| SODBA SPLOŠNEGA SODIŠČA (deveti senat) | JUDGMENT OF THE GENERAL COURT (Ninth Chamber) |
| z dne 8. septembra 2016 ( *1 ) | 8 September 2016 ( 1 ) |
| „Konkurenca — Omejevalni sporazumi — Trg zdravil proti depresiji z aktivno farmacevtsko učinkovino citalopram — Pojem omejevanje konkurence zaradi cilja — Potencialna konkurenca — Generična zdravila — Ovire za vstop na trg zaradi patentov — Sporazumi med imetnikom patentov in podjetji za generična zdravila — Člen 101(1) in (3) PDEU — Napačna uporaba prava in presoja — Obveznost obrazložitve — Pravica do obrambe — Pravna varnost — Globe“ | ‛Competition — Agreements, decisions and concerted practices — Market for antidepressant medicinal products containing the active pharmaceutical ingredient citalopram — Concept of restriction of competition ‘by object’ — Potential competition — Generic medicinal products — Barriers to market entry resulting from the existence of patents — Agreements concluded between a patent holder and generic undertakings — Article 101(1) and (3) TFEU — Errors of law and of assessment — Obligation to state reasons — Rights of defence — Legal certainty — Fines’ |
| V zadevi T‑472/13, | In Case T‑472/13, |
| H. Lundbeck A/S s sedežem v Valbyju (Danska), | H. Lundbeck A/S, established in Valby (Denmark), |
| in | and |
| Lundbeck Ltd s sedežem v Milton Keynesu (Združeno kraljestvo), | Lundbeck Ltd, established in Milton Keynes (United Kingdom), |
| ki ju zastopata R. Subiotto, QC, in T. Kuhn, odvetnika, | represented by R. Subiotto QC, and T. Kuhn, lawyer, |
| tožeči stranki, | applicants, |
| ob intervenciji | supported by |
| European Federation of Pharmaceutical Industries and Associations (EFPIA) s sedežem v Ženevi (Švica), ki ga zastopata F. Carlin, barrister, in M. Healy, solicitors, | European Federation of Pharmaceutical Industries and Associations (EFPIA), established in Geneva (Switzerland), represented by F. Carlin, Barrister, and M. Healy, Solicitor, |
| intervenient, | intervener, |
| proti | v |
| Evropski komisiji, ki so jo najprej zastopali J. Bourke, F. Castilla Contreras, B. Mongin, T. Vecchi in C. Vollrath, nato F. Castilla Contreras, B. Mongin, T. Vecchi, C. Vollrath, in T. Christoforou, agenti, | European Commission, represented initially by J. Bourke, F. Castilla Contreras, B. Mongin, T. Vecchi and C. Vollrath, and subsequently by F. Castilla Contreras, B. Mongin, T. Vecchi, C. Vollrath and T. Christoforou, acting as Agents, |
| tožena stranka, | defendant, |
| zaradi predloga za razglasitev delne ničnosti Sklepa Komisije C(2013) 3808 final z dne 19. junija 2013 v zvezi s postopkom na podlagi člena 101 [PDEU] in člena 53 Sporazuma o Evropskem gospodarskem prostoru (zadeva AT/39226 – Lundbeck) ter znižanja zneska globe, ki je bila s tem sklepom naložena tožečima strankama, | APPLICATION for annulment in part of Commission Decision C(2013) 3803 final of 19 June 2013 relating to a proceeding under Article 101 [TFEU] and Article 53 of the EEA Agreement (Case AT.39226 — Lundbeck) and for reduction of the amount of the fine imposed on the applicants by that decision, |
| SPLOŠNO SODIŠČE (deveti senat), | THE GENERAL COURT (Ninth Chamber), |
| v sestavi G. Berardis (poročevalec), predsednik, O. Czúcz in A. Popescu, sodnika, | composed of G. Berardis (Rapporteur), President, O. Czúcz and A. Popescu, Judges |
| sodni tajnik: L. Grzegorczyk, administrator, | Registrar: L. Grzegorczyk, Administrator, |
| na podlagi pisnega postopka in obravnave z dne 26. novembra 2015 | having regard to the written procedure and further to the hearing on 26 November 2015, |
| izreka naslednjo | gives the following |
| Sodbo | Judgment |
| Povzetek dejanskega stanja | Summary of the facts and background to the dispute |
| I – Družbe, obravnavane v tej zadevi | I – The companies involved in the present case |
| 1 | H. Lundbeck A/S je družba danskega prava, ki je nadrejena skupini družb, tudi družbi Lundbeck Ltd v Združenem kraljestvu, in je specializirana za raziskave, razvoj, trženje, prodajo in distribucijo farmacevtskih proizvodov za zdravljenje patologij, ki prizadenejo osrednji živčni sistem, tudi depresije (v nadaljevanju: družba Lundbeck). | 1 | H. Lundbeck A/S (‘Lundbeck’) is a company governed by Danish law which controls a group of companies, including Lundbeck Ltd, established in the United Kingdom, specialising in the research, development, manufacture, marketing, sale and distribution of pharmaceuticals for the treatment of disorders in the central nervous system, including depression. |
| 2 | Družba Lundbeck je proizvajalec originalnih zdravil, torej podjetje, ki svojo dejavnost osredotoča na raziskovanje novih zdravil in njihovo trženje. | 2 | Lundbeck is an ‘originator’ undertaking, namely an undertaking whose activities are focused on researching new medicinal products and bringing them to the market. |
| 3 | Merck KGaA je družba nemškega prava, specializirana za farmacijo, ki je imela v času sklenitve zadevnih sporazumov posredno prek skupine Merck Generics Holding GmbH v stoodstotni lasti svojo hčerinsko družbo Generics UK Limited (v nadaljevanju: družba GUK), družbo za razvoj in trženje generičnih farmacevtskih proizvodov v Združenem kraljestvu. | 3 | Merck KGaA (‘Merck’) is a company governed by German law specialising in the pharmaceutical sector which, at the time the agreements concerned were concluded, indirectly held 100% — through the group Merck Generics Holding GmbH (‘Merck Generics’) — of its subsidiary Generics UK Limited (‘GUK’), a company responsible for the development and marketing of generic pharmaceutical products in the United Kingdom. |
| 4 | Evropska komisija je družbi Merck in GUK v času upoštevnih dejstev obravnavala kot eno podjetje v smislu prava konkurence (v nadaljevanju: podjetje Merck (GUK)). | 4 | The Commission regarded Merck and GUK as constituting a single undertaking for the purpose of competition law at the time of the infringements (‘Merck (GUK)’). |
| 5 | Arrow Group A/S, ki se je avgusta 2003 preimenovala v Arrow Group ApS (v nadaljevanju: povsod: družba Arrow Group), je družba danskega prava na vrhu skupine družb, ki so prisotne v več državah članicah in so od leta 2001 dejavne pri razvoju in prodaji generičnih zdravil. | 5 | Arrow Group A/S, which was renamed Arrow Group ApS in August 2003 (hereinafter referred to without distinction as ‘Arrow Group’), is a company governed by Danish law at the head of a group of companies, present in several Member States, which since 2001 has been active in the development and sales of generic medicinal products. |
| 6 | Arrow Generics Ltd je družba prava Združenega kraljestva, hčerinska družba, ki je bila sprva v stoodstotni, nato pa po februarju 2002 v 76‑odstotni lasti družbe Arrow Group. | 6 | Arrow Generics Ltd is a company incorporated in the United Kingdom, a subsidiary owned at first as to 100% and then, from February 2002, as to 76% by Arrow Group. |
| 7 | Resolution Chemicals Ltd je družba prava Združenega kraljestva, specializirana za proizvodnjo aktivnih farmacevtskih učinkovin (v nadaljevanju: AFU) za generična zdravila. Do septembra 2009 jo je nadzorovala družba Arrow Group. | 7 | Resolution Chemicals Ltd is a company incorporated in the United Kingdom specialising in the production of active pharmaceutical ingredients (‘APIs’) for generic medicinal products. Until September 2009 it was controlled by Arrow Group. |
| 8 | Komisija je družbe Arrow Group, Arrow Generics Ltd in Resolution Chemicals Ltd v času upoštevnih dejstev obravnavala kot eno podjetje (v nadaljevanju: podjetje Arrow). | 8 | The Commission regarded Arrow Group, Arrow Generics Ltd and Resolution Chemicals Ltd as constituting a single undertaking (‘Arrow’) at the time of the infringements. |
| 9 | Alpharma Inc. je bila družba prava Združenih držav Amerike, ki je po celem svetu poslovala v farmacevtskem sektorju, zlasti v zvezi z generičnimi zdravili. Do leta 2008 jo je nadzirala družba norveškega prava A.L. Industrier AS. Nato jo je kupilo britansko farmacevtsko podjetje, ki ga je nato kupilo farmacevtsko podjetje iz Združenih držav. Pri tem prestrukturiranju je Alpharma Inc. aprila 2010 najprej postala Alpharma, LLC, nato pa 15. aprila 2013 družba Zoetis Products LLC. | 9 | Alpharma Inc. was a company incorporated in the United States of America active in the pharmaceutical sector on a worldwide scale, in particular in generic medicinal products. Until December 2008 it was controlled by A.L. Industrier AS, a company governed by Norwegian law. It was subsequently bought by a United Kingdom pharmaceutical undertaking, which, in turn, was bought by a United States pharmaceutical undertaking. In the context of those restructurings, Alpharma Inc. became, first of all, in April 2010, Alpharma LLC, and then, on 15 April 2013, Zoetis Products LLC. |
| 10 | Alpharma ApS je bila družba danskega prava v posredni stoodstotni lasti družbe Alpharma Inc. Imela je več hčerinskih družb v Evropskem gospodarskem prostoru (EGP). Po več prestrukturiranjih je Alpharma ApS 31. marca 2008 postala Axellia Pharmaceuticals ApS, ki se je leta 2010 preimenovala v Xellia Pharmaceuticals ApS (v nadaljevanju: družba Xellia). | 10 | Alpharma ApS was a company governed by Danish law indirectly controlled as to 100% by Alpharma Inc. It had a number of subsidiaries in the European Economic Area (EEA). Following a number of company restructurings, on 31 March 2008 Alpharma ApS became Axellia Pharmaceuticals ApS, renamed Xellia Pharmaceuticals ApS (‘Xellia’) in 2010. |
| 11 | Komisija je družbe Alpharma Inc., A.L. Industrier AS in Alpharma ApS v času upoštevnih dejstev obravnavala kot eno podjetje (v nadaljevanju: podjetje Alpharma). | 11 | The Commission regarded Alpharma Inc., A.L. Industrier AS and Alpharma ApS as constituting a single undertaking (‘Alpharma’) at the time of the infringements. |
| 12 | Ranbaxy Laboratories Ltd je družba indijskega prava, specializirana za razvoj in proizvodnjo AFU ter generičnih zdravil. | 12 | Ranbaxy Laboratories Ltd is a company governed by Indian law specialising in the development and production of APIs and generic medicinal products. |
| 13 | Ranbaxy (UK) Ltd je družba angleškega prava, hčerinska družba družbe Ranbaxy Laboratories, ki je zadolžena za prodajo proizvodov zadnjenavedene v Združenem kraljestvu. | 13 | Ranbaxy (UK) Ltd is a company governed by English law and a subsidiary of Ranbaxy Laboratories and is responsible for the sale of the latter’s products in the United Kingdom. |
| 14 | Komisija je družbi Ranbaxy Laboratories Ltd in Ranbaxy (UK) Ltd v času upoštevnih dejstev obravnavala kot eno podjetje (v nadaljevanju: podjetje Ranbaxy). | 14 | The Commission regarded Ranbaxy Laboratories Ltd and Ranbaxy (UK) Ltd as constituting a single undertaking (‘Ranbaxy’) at the time of the infringements. |
| II – Zadevni proizvod in patenti v zvezi z njim | II – The relevant product and the applicable patents |
| 15 | Proizvod, na katerega se nanaša ta zadeva, je zdravilo proti depresiji z AFU citalopram. | 15 | The relevant product for the purposes of the present case is the antidepressant medicinal product containing the API known as citalopram. |
| 16 | Družba Lundbeck je leta 1977 na Danskem prijavila patent za AFU citalopram in dva postopka alkilacije in cianacije, ki se uporabljata pri proizvodnji navedene AFU. Patenti v zvezi s to AFU in tema dvema postopkoma (v nadaljevanju: izvirni patenti) so bili izdani na Danskem in v več zahodnoevropskih državah med letoma 1977 in 1985. | 16 | In 1977, Lundbeck filed a patent application in Denmark for the citalopram API and two processes — a cyanation process and an alkylation process — to produce that API. Patents for that API and those two processes (‘the original patents’) were issued in Denmark and in a number of Western European countries between 1977 and 1985. |
| 17 | Kar zadeva EGP, je zaščita na podlagi izvirnih patentov ter – odvisno od primera – dodatnih varstvenih certifikatov (v nadaljevanju: DVC) iz Uredbe Sveta (EGS) št. 1768/92 z dne 18. junija 1992 o uvedbi dodatnega varstvenega certifikata za zdravila (UL, posebna izdaja v slovenščini, poglavje 13, zvezek 11, str. 200) potekla med letoma 1994 (v Nemčiji) in 2003 (v Avstriji). Kar zadeva posebej Združeno kraljestvo so izvirni patenti potekli januarja 2002. | 17 | As regards the European Economic Area (EEA), the protection afforded by the original patents and, where appropriate, the supplementary protection certificates (‘SPCs’) provided for in Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ 1992 L 182, p. 1), expired between 1994 (as regards Germany) and 2003 (as regards Austria). In particular, in the case of the United Kingdom, the original patents expired in January 2002. |
| 18 | Družba Lundbeck je sčasoma razvila druge učinkovitejše postopke za proizvodnjo citaloprama, v zvezi s katerimi je prijavila in pogosto tudi pridobila patente v več državah EGP ter pri Svetovni organizaciji za intelektualno lastnino (SOIL) in Evropskem patentnem uradu (EPU) (v nadaljevanju: novi patenti družbe Lundbeck). | 18 | Over time, Lundbeck developed other, more effective, processes for the production of citalopram, in respect of which it applied for and often obtained patents in several EEA countries and also from the World Intellectual Property Organisation (WIPO) and the European Patent Office (EPO) (‘Lundbeck’s new patents’). |
| 19 | Natančneje, prvič, družba Lundbeck je leta 1998 in 1999 pri EPU vložila dve prijavi za patente v zvezi s proizvodnjo citaloprama po postopkih z uporabo joda oziroma amida. EPU je družbi Lundbeck 19. septembra 2001 izdal patent za zaščito postopka z uporabo amida (v nadaljevanju: patent za amid), 26. marca 2003 pa patent za zaščito postopka z uporabo joda (v nadaljevanju: patent za jod). | 19 | In particular, first, in 1998 and in 1999 Lundbeck applied to the EPO for two patents relating to the production of citalopram by processes using iodo and amide, respectively. The EPO granted Lundbeck a patent protecting the process using amide (‘the amide patent’) on 19 September 2001 and a patent protecting the process using the iodo (‘the iodo patent’) on 26 March 2003. |
| 20 | Drugič, družba Lundbeck je 13. marca 2000 pri danskih organih vložila zahtevo za patent v zvezi s postopkom za proizvodnjo citaloprama, ki je določal metodo prečiščevanja uporabljenih soli s kristalizacijo. Podobne prijave so bile vložene v drugih državah EGP ter pri SOIL in EPU. Družba Lundbeck je pridobila patente za zaščito postopka z uporabo kristalizacije v več državah članicah v prvi polovici leta 2002, v Združenem kraljestvu 30. januarja 2002. EPU je izdal patent za kristalizacijo 4. septembra 2002. Poleg tega je družba Lundbeck na Nizozemskem že 6. novembra 2000 pridobila uporabni model za ta postopek (v nadaljevanju: uporabni model družbe Lundbeck), torej šest let veljaven patent, pridobljen brez prave predhodne presoje. | 20 | Secondly, on 13 March 2000 Lundbeck filed a patent application with the Danish authorities relating to a process for the production of citalopram which envisaged a method of purification of the salts used by means of crystallisation. Similar applications were filed in other EEA countries and also with the WIPO and the EPO. Lundbeck obtained patents protecting the crystallisation process in a number of Member States during the first half of 2002: 30 January 2002 in the case of the United Kingdom (‘the crystallisation patent’). The EPO granted a crystallisation patent on 4 September 2002. In addition, in the Netherlands, Lundbeck had already obtained, on 6 November 2000, a utility model for that process (‘Lundbeck’s utility model’), that is to say, a patent valid for six years, granted without a genuine prior examination. |
| 21 | Tretjič, družba Lundbeck je 12. marca 2001 vložila patentno prijavo pri organih Združenega kraljestva v zvezi s postopkom za proizvodnjo citaloprama z uporabo metode prečiščenja soli s filmsko destilacijo. Organi Združenega kraljestva so družbi Lundbeck 3. oktobra 2001 izdali patent za navedeno metodo filmske destilacije (v nadaljevanju: patent za filmsko destilacijo). Vendar je bil ta patent 23. junija 2004 razveljavljen, ker ni bil nov glede na drug patent družbe Lundbeck. Družba Lundbeck je podoben patent 29. junija 2002 pridobila na Danskem. | 21 | Thirdly, on 12 March 2001, Lundbeck filed a patent application with the United Kingdom authorities for a citalopram production process using a salt purification method by film distillation. The United Kingdom authorities granted Lundbeck a patent for that film distillation method on 3 October 2001 (‘the film distillation patent’). However, that patent was revoked on 23 June 2004 for lack of novelty by comparison with another Lundbeck patent. Lundbeck obtained a similar patent in Denmark on 29 June 2002. |
| 22 | Nazadnje, družba Lundbeck je konec leta 2002 ali na začetku leta 2003 nameravala dati na trg novo zdravilo proti depresiji, Cipralex, ki je temeljilo na AFU escitalopram (ali S‑citalopram). To novo zdravilo je bilo namenjeno istim bolnikom kot so tisti, ki so se lahko zdravili s patentiranim zdravilom Cipramil družbe Lundbeck, ki je temeljilo na AFU citalopram. AFU citalopram je bila zaščitena z veljavnimi patenti vsaj do leta 2012. | 22 | Lastly, Lundbeck planned to launch a new antidepressant medicinal product, Cipralex, based on the API known as escitalopram (or S-citalopram), by the end of 2002 or the beginning of 2003. That new medicinal product was designed for the same patients as those who could be treated by Lundbeck’s patented medicinal product Cipramil, based on the citalopram API. The escitalopram API was protected by patents valid until at least 2012. |
| III – Sporni sporazumi | III – The agreements at issue |
| 23 | Družba Lundbeck je leta 2002 sklenila šest sporazumov v zvezi s citalopramom (v nadaljevanju: sporni sporazumi) s podjetji, ki proizvajajo in/ali prodajajo generična zdravila, in sicer podjetji Merck (GUK), Alpharma, Arrow in Ranbaxy (v nadaljevanju: generična podjetja). | 23 | In 2002, Lundbeck entered into six agreements concerning citalopram (‘the agreements at issue’) with four undertakings active in the production and/or sale of generic medicinal products, namely Merck (GUK), Alpharma, Arrow and Ranbaxy (‘the generic undertakings’). |
| A – Sporazuma s podjetjem Merck (GUK) | A – The agreements with Merck (GUK) |
| 24 | Družba Lundbeck je s podjetjem Merck (GUK) sklenila dva sporazuma. | 24 | Lundbeck entered into two agreements with Merck (GUK). |
| 25 | Prvi sporazum je začel veljati 24. januarja 2002, sprva za obdobje enega leta in izključno na ozemlju Združenega kraljestva (v nadaljevanju: sporazum GUK za Združeno kraljestvo). Podpisala ga je družba prava Združenega kraljestva Lundbeck Ltd, hčerinska družba družbe Lundbeck A/S v Združenem kraljestvu. Ta sporazum je bil nato podaljšan za šest mesecev do 31. julija 2003. Nato sta stranki 6. avgusta 2003, po kratkem vstopu na trg podjetja Merck (GUK) med 1. in 4. avgustom, podpisali drugo podaljšanje za največ šest mesecev, ki pa se bi lahko skrajšalo, če družba Lundbeck ne bi sodno ukrepala zoper druga generična podjetja, ki bi poskušala vstopiti na trg, ali po koncu spora med družbama Lundbeck in Lagap Pharmaceuticals Ltd, drugim generičnim podjetjem (v nadaljevanju: spor Lagap). | 25 | The first agreement came into effect on 24 January 2002 for a period of one year, and covered only the territory of the United Kingdom (‘the GUK United Kingdom agreement’). It was signed by Lundbeck A/S’s subsidiary, Lundbeck Ltd, a company incorporated in the United Kingdom. That agreement was subsequently extended for a period of six months, ending on 31 July 2003. Next, after Merck (GUK) briefly entered the market between 1 and 4 August, a second extension of the agreement was signed by the parties on 6 August 2003, for a maximum period of six months, which could be reduced if Lundbeck failed to initiate legal proceedings against other generic undertakings which attempted to enter the market or on determination of the litigation between Lundbeck and Lagap Pharmaceuticals Ltd, another generic undertaking (‘the Lagap litigation’). |
| 26 | V tem sporazumu sta se stranki med drugim dogovorili, da: | — | obstaja tveganje, da nekatera dejanja, ki jih družba GUK namerava storiti v zvezi s trženjem, distribucijo in prodajo „Proizvodov“, lahko pomenijo kršitev pravic intelektualne lastnine družbe Lundbeck, in da bi lahko ta zoper njo vložila tožbe (člen 2.1 sporazuma GUK za Združeno kraljestvo), ti „Proizvodi“ pa so v členu 1.1 sporazuma opredeljeni kot „proizvodi iz citaloprama, ki jih je družba GUK razvila v obliki surovine, v nepakiranem stanju ali v obliki tablet, kot so navedeni v Prilogi in proizvedeni v skladu s specifikacijo proizvodov kot jo je predložila družba GUK na dan podpisa v prilogi 2;“ | — | bo družba Lundbeck na podlagi sporazuma med strankama družbi GUK 31. januarja 2002 plačala dva milijona britanskih funtov (GBP) v zameno za dobavo „Proizvodov“ v količinah, določenih v sporazumu (člen 2.2 sporazuma GUK za Združeno kraljestvo); | — | se družba GUK poleg tega zavezuje, da bo 2. aprila 2002 v zameno za dodatno plačilo enega milijona GBP dobavila „Proizvode“, kot so opredeljeni v prilogi (člen 2.3 sporazuma GUK za Združeno kraljestvo); | — | sta plačilo in dobava „Proizvodov“ družbe GUK na podlagi členov 2.2 in 2.3 celovita in končna rešitev vsakršnih zahtevkov, ki bi jih družba Lundbeck lahko imela zoper družbo GUK zaradi kršitve njenih pravic intelektualne lastnine v zvezi s „Proizvodi“, ki jih je družba GUK dobavila do tega dne (člen 2.4 sporazuma GUK za Združeno kraljestvo); | — | se družba Lundbeck zavezuje svoje „Končne proizvode“ prodajati družbi GUK, družba GUK pa se zavezuje, da bo te „Končne proizvode“ kupovala izključno pri družbi Lundbeck zaradi nadaljnje prodaje družbe GUK in njenih povezanih družb v Združenem kraljestvu za obdobje in pod pogoji, določenimi v sporazumu (člen 3.2 sporazuma GUK za Združeno kraljestvo), ti „Končni proizvodi“ pa so opredeljeni v členu 1.1 sporazuma kot „proizvodi z vsebnostjo citaloprama v obliki končnega paketa, ki ga [družba Lundbeck] dobavi družbi GUK v skladu s tem sporazumom;“ | — | se družba Lundbeck zavezuje plačati družbi GUK pet milijonov GBP zajamčenega čistega dobička, če družba GUK pri njej naroči dogovorjeno količino „Končnih proizvodov“ med trajanjem sporazuma (ali manjši znesek, izračunan obročno glede na izvedena naročila) (člen 6.2 sporazuma GUK za Združeno kraljestvo). | 26 | Under that agreement, the parties agreed, in particular, that: | — | there was a risk that certain actions envisaged by GUK in respect of the marketing, distribution and sale of the ‘Products’ might constitute an infringement of Lundbeck’s intellectual property rights and could give rise to claims on the part of Lundbeck (Article 2.1 of the GUK United Kingdom agreement), the ‘Products’ being defined in Article 1.1 of the GUK United Kingdom agreement as ‘the citalopram products developed by GUK in raw material, bulk product and finished pack form as set out in the Schedule and manufactured in accordance with the specification for Products as supplied by GUK at the date of signature. Attached to Schedule 2’; | — | in view of the agreement between the parties, Lundbeck would pay GUK the sum of 2 million pounds sterling (GBP), in consideration for the delivery of the ‘Products’, in the quantities set out in the agreement, on 31 January 2002 (Article 2.2 of the GUK United Kingdom agreement); | — | GUK also undertook, in consideration of a further payment of GBP 1 million, to deliver the ‘Products’, as specified in the schedule, on 2 April 2002 (Article 2.3 of the GUK United Kingdom agreement); | — | the payments made and the delivery of the ‘Products’ by GUK pursuant to Articles 2.2 and 2.3 of the GUK United Kingdom would constitute full and final settlement of any claim that Lundbeck might have against GUK for infringement of its intellectual property rights in connection with the ‘Products’ delivered by GUK up to that date (Article 2.4 of the UK agreement); | — | Lundbeck undertook to sell its ‘Finished Products’ to GUK and GUK undertook to purchase those ‘Finished Products’ exclusively from Lundbeck for resale by GUK and its affiliates in the United Kingdom during the term and subject to the conditions of the agreement (Article 3.2 of the GUK United Kingdom agreement), those ‘Finished Products’ being defined in paragraph 1.1 of the agreement as ‘products containing citalopram in finished pack form to be supplied by [Lundbeck] to GUK pursuant to this Agreement’; | — | Lundbeck undertook to pay GBP 5 million of guaranteed net profits to GUK, on condition that GUK ordered the agreed volume of ‘Finished Products’ during the term of the agreement (or a lesser amount to be calculated pro rata to the volume ordered) (Article 6.2 of the GUK United Kingdom agreement). |
| 27 | S prvim podaljšanjem sporazuma je bilo med drugim določeno mesečno plačilo 400.000 GBP za to, da je družba GUK izvajala člen 6.2 sporazuma, spremenjena pa je bila tudi opredelitev „čistega dobička“. | 27 | The first extension of the GUK United Kingdom agreement provided, in particular, for monthly payments of the sum of GBP 400000 per month for the implementation of Article 6.2 of the agreement by GUK and amended the definition of ‘net profits’. |
| 28 | Z drugim podaljšanjem sporazuma je bilo med drugim določeno mesečno plačilo 750.000 GBP za to, da je družba GUK izvajala člen 6.2 sporazuma. | 28 | The second extension of the GUK United Kingdom agreement provided, in particular, for monthly payments of the sum of GBP 750000 per month for the implementation of Article 6.2 of the agreement by GUK. |
| 29 | Sporazum GUK za Združeno kraljestvo je potekel 1. novembra 2003 po poravnavi spora Lagap. Družba Lundbeck je v času trajanja sporazuma plačala družbi GUK skupaj 19,4 milijona eurov v protivrednosti. | 29 | The GUK United Kingdom agreement expired on 1 November 2003, following the settlement of the Lagap litigation. In total, over the entire term of the agreement, Lundbeck transferred the equivalent of EUR 19.4 million to GUK. |
| 30 | Družbi Lundbeck in GUK sta 22. oktobra 2002 sklenili drugi sporazum, ki je zajemal EGP, razen Združeno kraljestvo (v nadaljevanju: sporazum GUK za EGP). Ta sporazum je določal plačilo 12 milijonov eurov, v zameno za to pa se je družba GUK zavezala, da na celotnem ozemlju EGP (razen v Združenem kraljestvu) ne bo prodajala niti dobavljala farmacevtskih proizvodov z vsebnostjo citaloprama in da si bo kar najbolj prizadevala, da bo družba Natco Pharma Ltd (v nadaljevanju: družba Natco) – proizvajalka AFU citalopram, razvitega z njenimi proizvodnimi postopki, ki ga je podjetje Merck (GUK) uporabljalo za trženje svoje različice generičnega citaloprama (v nadaljevanju: AFU družbe Natco ali citalopram družbe Natco) – v EGP v času trajanja sporazuma prenehala dobavljati citalopram ali proizvode z vsebnostjo citaloprama (člena 1.1 in 1.2 sporazuma GUK za EGP). Družba Lundbeck se je zavezala, da ne bo sprožila sodnih postopkov proti družbi GUK, če bo ta spoštovala svoje obveznosti na podlagi člena 1.1 sporazuma (člen 1.3 sporazuma GUK za EGP). | 30 | A second agreement was concluded between Lundbeck and GUK on 22 October 2002, covering the EEA excluding the United Kingdom (‘the GUK EEA agreement’). That agreement provided for payment of the sum of EUR 12 million, in consideration whereof GUK undertook not to sell or supply pharmaceutical products containing citalopram throughout the EEA (excluding the United Kingdom) and to use all reasonable efforts to ensure that Natco Pharma Ltd (‘Natco’) — the manufacturer of the citalopram API used by Merck (GUK) to market its version of generic citalopram (‘the Natco API’ or ‘the Natco citalopram’) — ceased to supply citalopram and products containing Citalopram in the EEA during the term of the agreement (Articles 1.1 and 1.2 of the GUK EEA agreement). Lundbeck undertook not to bring legal proceedings against GUK, on condition that GUK complied with its obligations under Article 1.1 of the GUK EEA agreement (Article 1.3 of the GUK EEA agreement). |
| 31 | Sporazum GUK za EGP je potekel 22. oktobra 2003. Družba Lundbeck je v skladu s tem sporazumom družbi GUK plačala skupaj 12 milijonov eurov. | 31 | The GUK EEA agreement expired on 22 October 2003. In total, Lundbeck transferred the equivalent of EUR 12 million to GUK under that agreement. |
| B – Sporazuma s podjetjem Arrow | B – The agreements with Arrow |
| 32 | Družba Lundbeck je s podjetjem Arrow podpisala dva sporazuma. | 32 | Lundbeck signed two agreements with Arrow. |
| 33 | Prvi od navedenih sporazumov, ki se je nanašal na ozemlje Združenega kraljestva, so 24. januarja 2002 sklenile družba Lundbeck na eni strani ter družbi Arrow Generics in Resolution Chemicals (v nadaljevanju: skupaj: družba Arrow UK) na drugi (v nadaljevanju: sporazum Arrow UK). | 33 | The first of those agreements, relating to the territory of the United Kingdom, was concluded on 24 January 2002 between, on the one hand, Lundbeck and, on the other, Arrow Generics and Resolution Chemicals (together ‘Arrow UK’) (‘the Arrow UK agreement’). |
| 34 | Prvotno trajanje sporazuma Arrow UK je bilo do 31. decembra 2002 ali – če bi se predčasno končal – do datuma pravnomočnosti sodne odločitve o tožbi, ki jo je družba Lundbeck nameravala vložiti zoper družbo Arrow UK pri sodiščih Združenega kraljestva, ker je zadnjenavedena kršila njene patente (v nadaljevanju: tožba zaradi kršitve zoper družbo Arrow) (člen 4.1 sporazuma Arrow UK). Pozneje je bil ta sporazum dvakrat podaljšan s podpisom aneksov. Prvo podaljšanje je zajemalo obdobje med 1. januarjem in 1. marcem 2003 (člen 3.1 prvega aneksa k sporazumu Arrow UK), z drugim pa je bilo določeno, da ta sporazum poteče 31. januarja 2004 ali sedem dni po podpisu sodne odločbe, s katero se konča spor Lagap (člen 4.1 drugega aneksa k sporazumu Arrow UK). Ker je bil navedeni spor končan s poravnavo 13. oktobra 2003, je sporazum Arrow UK potekel 20. oktobra istega leta. Iz tega sledi, da je ta sporazum skupaj trajal od 24. januarja 2002 do 20. oktobra 2003 (v nadaljevanju: trajanje sporazuma Arrow UK). | 34 | The initial term of the Arrow UK agreement was until 31 December 2002 or, if it had been earlier, until the date on which a definitive decision had been delivered in the action which Lundbeck intended to bring against Arrow UK before the United Kingdom courts concerning Arrow UK’s alleged infringement of its patents (‘the infringement action against Arrow’) (Article 4.1 of the Arrow UK agreement). That agreement was extended, on two occasions, by the signing of addenda. The first extension covered the period from 1 January until 1 March 2003 (Article 3.1 of the first addendum to the Arrow UK agreement), while the second extension provided that the agreement was to end either on 31 January 2004 or seven days after signature of the court decision determining the Lagap litigation (Article 4.1 of the second addendum to the Arrow UK agreement). As that litigation was settled on 13 October 2003, the Arrow UK agreement ended on 20 October 2003. It follows that the overall duration of that agreement was from 24 January 2002 until 20 October 2003 (‘the term of the Arrow UK agreement’). |
| 35 | V zvezi z vsebino sporazuma Arrow UK je treba ugotoviti, da: | — | v prvi uvodni izjavi preambule k temu sporazumu (v nadaljevanju: preambula sporazuma Arrow UK) je med drugim navedeno, da je družba Lundbeck imetnica patentov za kristalizacijo in filmsko destilacijo; | — | v četrti uvodni izjavi preambule sporazuma Arrow UK je pojasnjeno, da je „družba Arrow [UK] pridobila dovoljenje tretje osebe, da v Združeno kraljestvo uvaža citalopram, ki ga ne proizvaja družba Lundbeck ali se ne proizvaja z dovoljenjem družbe Lundbeck (opredelitev ‚navedeni Citalopram,‘ zaradi izogibanja vsakršnemu dvomu zajema samo citalopram, namenjen trženju in prodaji v Združenem kraljestvu, ne pa tudi Citalopram, namenjen trženju in prodaji v drugih državah)“; | — | v šesti uvodni izjavi preambule sporazuma Arrow UK je navedeno, da je družba Lundbeck „navedeni Citalopram“ laboratorijsko preizkusila, na podlagi česar je lahko utemeljeno sklepala, da se s tem citalopramom kršijo med drugim patenti iz prve alineje zgoraj; | — | v sedmi uvodni izjavi preambule sporazuma Arrow UK je navedeno, da družba Arrow UK ne priznava, da je kršila te patente, niti da so ti veljavni, priznava pa, da družba Lundbeck meni, da bi bili lahko veljavni in kršeni, česar družba Arrow UK ne more ovreči z neizpodbitnimi dokazi; | — | v osmi uvodni izjavi preambule sporazuma Arrow UK je opozorjeno, da je družba Lundbeck grozila z vložitvijo predloga za izdajo začasne odredbe, in da namerava vložiti tožbo zaradi kršitev zoper družbo Arrow [UK]; | — | je v členu 1.1 navedenega sporazuma določeno, da „se družba Arrow [UK] v svojem imenu in v imenu vseh pridruženih in povezanih subjektov zavezuje, da med [trajanjem sporazuma Arrow UK] na ozemlju Združenega kraljestva ne bo proizvajala, odsvajala, ponujala odsvojitve, uporabljala ali, po drugem datumu dobave, uvažala ali hranila zaradi odsvojitve ali za drug namen (1) [‚]navedeni Citalopram[‘] ali (2) kateri koli drug citalopram, s katerim se po mnenju družbe Lundbeck kršijo pravice [intelektualne] lastnine, in da bo za to, da bo družba Lundbeck lahko ugotovila obstoj kršitve, tej v [času trajanja sporazuma Arrow UK] dobavila dovolj vzorcev za analizo vsaj en mesec pred vsakršno zagroženo proizvodnjo, uvozom, prodajo ali ponudbo prodaje do končne odločitve [o tožbi zaradi kršitev zoper družbo Arrow UK], zoper katero ni pravnega sredstva […];“ | — | je v členu 1.2 navedenega sporazuma navedeno, da družba Arrow UK soglaša s tem, da se njene zaveze iz člena 1.1 sporazuma vključijo v sklep, katerega sprejetje bi družba Lundbeck lahko zahtevala pri pristojnem sodišču Združenega kraljestva; | — | je v členu 2.1 navedenega sporazuma opozorjeno, da bo družba Lundbeck vložila tožbo zaradi kršitev zoper družbo Arrow [UK], takoj ko bo mogoče, vsekakor pa najpozneje 31. marca 2002; | — | je v členu 2.2 navedenega sporazuma določeno, da družba Lundbeck v zameno za zaveze iz člena 1.1 sporazuma Arrow UK in za to, da družba Arrow UK ne bo zahtevala „cross‑undertaking in damages“ (torej znesek, ki bi ga morala družba Lundbeck v skladu s pravom Anglije in Walesa deponirati pri sodišču, pri katerem je nameravala v okviru tožbe zaradi kršitev zoper družbo Arrow [UK] predlagati sprejetje začasne odredbe), plača družbi Arrow UK pet milijonov GBP v štirih obrokih, ta znesek je bil pozneje v skladu s členom 2.1 prvega aneksa k sporazumu Arrow UK povišan za 450.000 GBP, nato pa še za 1,35 milijona GBP v skladu s členoma 2.1 in 3 drugega aneksa k navedenemu sporazumu; | — | je v členu 2.3 navedenega sporazuma določeno, da če bi bilo s pravnomočno odločbo v okviru tožbe zaradi kršitev zoper družbo Arrow UK ugotovljeno, da družba Arrow UK ni kršila pravic intelektualne lastnine družbe Lundbeck, bo znesek iz člena 2.2 navedenega sporazuma pomenil celotno in končno nadomestilo, ki bi ga družba Arrow UK lahko dobila od družbe Lundbeck zaradi izgub, ki jih je utrpela zaradi obveznosti na podlagi člena 1.1 sporazuma Arrow UK; | — | člen 3.4 sporazuma določa, da bo družba Arrow UK dostavila družbi Lundbeck svojo zalogo „navedenega Citaloprama“ v dveh fazah, od katerih bi se morala prva, ki zadeva približno 3,975 milijona pakiranih tablet, zgoditi najpozneje 6. februarja 2002, druga, ki zadeva približno 1,1 milijona nepakiranih tablet, pa najpozneje 15. februarja 2002. | 35 | As regards the content of the Arrow United Kingdom agreement, it should be observed that: | — | the first recital in the preamble to that agreement (‘the Arrow UK preamble’) refers, inter alia, to the fact that Lundbeck is the holder of the crystallisation and film distillation patents; | — | the fourth recital in the Arrow UK preamble states that ‘… Arrow [UK] has obtained a licence from a third party to import into the [United Kingdom] Citalopram not manufactured by Lundbeck or with the consent of Lundbeck (“the said Citalopram”, which definition shall for the avoidance of doubt comprise only citalopram for marketing and sale in the [United Kingdom] and shall exclude Citalopram for marketing and sale in other countries)’; | — | the sixth recital in the Arrow UK preamble states that Lundbeck performed a laboratory analysis of ‘the said Citalopram’ which gave it substantial reason to believe that that citalopram infringed, in particular, the patents referred to in the first indent above; | — | the seventh recital in the Arrow UK preamble states that Arrow UK does not consider that it has infringed those patents or that they are valid, but accepts that Lundbeck believes that they may be valid and have been infringed, which Arrow UK is unable to disprove by incontrovertible evidence; | — | the eighth recital in the preamble to that agreement observes that Lundbeck has threatened to seek an interim injunction and that it intends to bring infringement proceedings against Arrow; | — | Article 1.1 of that agreement provides that ‘Arrow [UK] on its own behalf and on behalf of all associated and related entities undertakes during the [term of the Arrow UK agreement] not in the United Kingdom to make, dispose of, offer to dispose of, use or, after the second delivery date, import or keep for disposal or otherwise (1) the said Citalopram or (2) any other Citalopram which Lundbeck alleges to infringe its [intellectual property] Rights and, to enable Lundbeck to ascertain if there may be an infringement, during the [term of the Arrow UK agreement] to provide Lundbeck with sufficient samples for analysis purposes at least one month prior to any threatened manufacture, importation, sale or offer for sale pending a final unappealable decision in [the infringement action against Arrow] …’; | — | Article 1.2 of that agreement states that Arrow UK has agreed that the undertakings given by it and referred to in Article 1.1 of the Arrow UK agreement may be incorporated in an order that Lundbeck might ask the competent United Kingdom court to make; | — | Article 2.1 of that agreement states that Lundbeck will commence the infringement action against Arrow as soon as possible and in any event no later than 31 March 2002; | — | Article 2.2 of that agreement states that, in consideration of the undertakings in Article 1.1 of the Arrow UK agreement and Arrow not seeking a ‘cross-undertaking in damages’ (i.e. the amount which, in accordance with the laws of England and Wales, Lundbeck would have had to deposit with the Court if it intended to seek an injunction in the infringement action against Arrow), Lundbeck is to pay Arrow UK GBP 5 million, in four instalments, that sum having subsequently been increased by GBP 450000 under Article 2.1 of the first addendum to the Arrow UK agreement, and by GBP 1.35 million in application of Articles 2.1 and 3 of the second addendum to the Arrow UK agreement; | — | Article 2.3 of that agreement establishes that, in the event that the final decision in the infringement action against Arrow should find that Arrow UK had not infringed Lundbeck’s intellectual property rights, the amount specified in Article 2.2 of that agreement would constitute the full and final compensation that Arrow UK could obtain from Lundbeck for loss sustained as a result of the obligations arising under Article 1.1 of the Arrow UK agreement; | — | Article 3.4 of the agreement provides that Arrow UK is to deliver to Lundbeck its stock ‘of said Citalopram’ in two stages, the first of which, covering approximately 3.975 million packed tablets, by no later than 6 February 2002 and the second, covering around 1.1 million bulk tablets, by no later than 15 February 2002. |
| 36 | Poleg tega je treba pojasniti, da je družba Lundbeck 6. februarja 2002 pridobila sklep iz člena 1.2 sporazuma Arrow UK (v nadaljevanju: sklep s soglasjem družbe Arrow). | 36 | It should be observed, moreover, that on 6 February 2002 Lundbeck obtained the order referred to in Article 1.2 of the Arrow UK agreement (‘the Arrow consent order’). |
| 37 | Drugi sporazum v zvezi z Dansko sta 3. junija 2002 sklenili družbi Lundbeck in Arrow Group (v nadaljevanju: danski sporazum Arrow). | 37 | The second agreement, concerning Denmark, was concluded on 3 June 2002 between Lundbeck and Arrow Group (‘the Arrow Danish agreement’). |
| 38 | Danski sporazum Arrow je bil sklenjen za obdobje od podpisa, 3. junija 2002, do 1. aprila 2003, ali – če bi se predčasno končal – do datuma pravnomočne sodne odločbe o tožbi zaradi kršitev zoper družbo Arrow [Group]. Ker take odločbe ni bilo, je navedeni sporazum veljal od 3. junija 2002 do 1. aprila 2003 (v nadaljevanju: trajanje danskega sporazuma Arrow). | 38 | The Arrow Danish agreement was intended to run from the date of signature, 3 June 2002, until 1 April 2003 or until such earlier date of a definitive decision in the infringement action against Arrow. As no such decision was delivered, the agreement was in force from 3 June 2002 until 1 April 2003 (‘the term of the Arrow Danish agreement’). |
| 39 | V zvezi z vsebino danskega sporazuma Arrow je treba ugotoviti, da: | — | so prva, tretja ter od pete do devete uvodne izjave njegove preambule v bistvu enake prvi, četrti, šesti, sedmi in osmi uvodni izjavi preambule sporazuma Arrow UK, medtem ko deveta uvodna izjava preambule danskega sporazuma Arrow omenja sklep s soglasjem družbe Arrow [Group]; | — | člen 1.1 navedenega sporazuma določa, da „se družba Arrow [Group] strinja z opustitvijo in prenehanjem vsakršnega uvoza, izdelave, proizvodnje, prodaje ali drugega trženja proizvodov z vsebnostjo Citaloprama, s katerim se po mnenju družbe Lundbeck kršijo njene pravice intelektualne lastnine na [danskem] ozemlju med trajanjem [danskega sporazuma Arrow];“ | — | člen 2.1 navedenega sporazuma določa, da družba Lundbeck plača družbi Arrow Group 500.000 ameriških dolarjev (USD) kot nadomestilo za zaveze zadnjenavedene; | — | člen 2.2 navedenega sporazuma določa, da če bi bilo s pravnomočno odločbo v okviru tožbe zaradi kršitev zoper družbo Arrow [Group] ugotovljeno, da družba Arrow Group ni kršila pravic intelektualne lastnine družbe Lundbeck, bo znesek iz člena 2.1 navedenega sporazuma pomenil celotno in končno nadomestilo, ki bi ga družba Arrow Group lahko dobila od družbe Lundbeck zaradi izgub, ki jih je utrpela zaradi obveznosti na podlagi člena 1.1 danskega sporazuma Arrow; | — | je v členu 3.1 navedenega sporazuma dodano, da družba Lundbeck po ceni 147.000 USD kupi zalogo citaloprama od družbe Arrow Group, kar pomeni približno en milijon tablet. | 39 | As regards the content of the Arrow Danish agreement, it should be observed that: | — | the first, third and fifth to ninth recitals in the preamble thereto correspond, in essence, to the first, fourth and sixth to eighth recitals in the Arrow UK preamble, it being noted that the ninth recital in the Arrow Danish preamble refers to the Arrow consent order; | — | Article 1.1 of that agreement provides that ‘Arrow [Group] consents to cancel, cease and desist from any importation, manufacture, production, sale or other marketing of products containing Citalopram which Lundbeck alleges to infringe its intellectual property rights in the [Danish] territory for the term of [the Arrow Danish agreement]’; | — | Article 2.1 of that agreement states that, as compensation for the undertakings given by Arrow Group, Lundbeck is to pay Arrow Group the sum of 500000 United States dollars (USD); | — | Article 2.2 of that agreement establishes that, in the event that the final decision in the infringement proceedings against Arrow should find that Arrow Group had not infringed Lundbeck’s intellectual property rights, the amount specified in Article 2.1 of that agreement would constitute the full and final compensation that Arrow Group could obtain from Lundbeck for loss sustained as a result of the obligations arising under Article 1.1 of the Arrow Danish agreement; | — | Article 3.1 of that agreement adds that Lundbeck is to purchase Arrow Group’s stock of citalopram, consisting of approximately 1 million tablets, for the price of USD 147000. |
| C – Sporazum s podjetjem Alpharma | C – The agreement with Alpharma |
| 40 | Družba Lundbeck je sporazum s podjetjem Alpharma podpisala 22. februarja 2002 (v nadaljevanju: sporazum Alpharma) za obdobje od navedenega datuma do 30. junija 2003 (v nadaljevanju: trajanje sporazuma Alpharma). | 40 | Lundbeck signed an agreement with Alpharma on 22 February 2002 (‘the Alpharma agreement’), to run from that date until 30 June 2003 (‘the term of the Alpharma agreement’). |
| 41 | Podjetje Alpharma je januarja 2002, pred sklenitvijo tega sporazuma, pri družbi Alfred E. Tiefenbacher GmbH & Co. (v nadaljevanju: družba Tiefenbacher) kupilo zalogo tablet generičnega citaloprama, razvitega iz AFU citalopram, ki jo po svojih postopkih proizvaja indijska družba Cipla (v nadaljevanju: citalopram družbe Cipla ali AFU družbe Cipla), od katere jih je naročilo še več. | 41 | Before concluding that agreement, in January 2002 Alpharma had bought from Alfred E. Tiefenbacher GmbH & Co. (‘Tiefenbacher’) a stock of generic citalopram tablets developed on the basis of the citalopram API produced by the Indian company Cipla according to its own processes (‘the Cipla citalopram’ or ‘the Cipla API’) and had ordered further supplies. |
| 42 | V zvezi s preambulo sporazuma Alpharma je treba med drugim ugotoviti, da: | — | je v prvi uvodni izjavi je opozorjeno, da „je družba Lundbeck imetnica pravic intelektualne lastnine, ki zajemajo zlasti patente v zvezi s proizvodnjo […] AFU ‚Citalopram‘ (pisano z velikim tiskanim ‚C‘ v celotnem besedilu sporazuma), vključno s patenti iz priloge A […]“ navedenega sporazuma (v nadaljevanju: priloga A); | — | je v drugi uvodni izjavi navedeno, da družba Lundbeck proizvaja in prodaja farmacevtske proizvode z vsebnostjo „Citaloprama“ v vseh državah članicah ter na Norveškem in v Švici, te države pa so skupaj opredeljene kot „Ozemlje“; | — | je v tretji in četrti uvodni izjavi omenjeno, da je podjetje Alpharma brez soglasja družbe Lundbeck proizvajalo ali kupovalo farmacevtske proizvode z vsebnostjo „Citaloprama“ na „Ozemlju“; | — | je v peti in šesti uvodni izjavi navedeno, da je družba Lundbeck laboratorijsko preizkusila proizvode podjetja Alpharma, na podlagi rezultatov pa je utemeljeno menila, da se s proizvodnimi metodami za te proizvode kršijo njene pravice intelektualne lastnine; | — | je v sedmi uvodni izjavi opozorjeno, da je družba Lundbeck 31. januarja 2002 vložila tožbo pri sodišču Združenega kraljestva (v nadaljevanju: tožba zaradi kršitev zoper podjetje Alpharma) s predlogom, da se podjetju Alpharma prepove „prodaja proizvodov z vsebnostjo Citaloprama zaradi kršitve pravic intelektualne lastnine družbe Lundbeck;“ | — | je v osmi uvodni izjavi navedeno, da podjetje Alpharma priznava, da so ugotovitve družbe Lundbeck pravilne in se zavezuje, da „takih proizvodov“ ne bo tržila; | — | deveta in deseta uvodna izjava določata, da se družba Lundbeck: | — | — | „zavezuje, da bo podjetju Alpharma plačala nadomestilo zaradi izognitve patentnemu sporu“, katerega izid ni mogoče napovedati s popolno gotovostjo in ki bi bil drag in dolgotrajen; | — | „zavezuje, da bo zaradi rešitve spora od podjetja Alpharma kupila njeno celotno zalogo proizvodov z vsebnostjo Citaloprama in ji plačala nadomestilo za te proizvode“. | 42 | As concerns the preamble to the Alpharma agreement, it should be observed, in particular, that: | — | the first recital states that ‘Lundbeck owns intellectual property rights including, in particular, patent rights relating to the manufacture of the [API] “Citalopram” [written with an upper case “C” throughout the agreement], including the patents set out in Appendix A’ to that agreement (‘Appendix A’); | — | the second recital states that Lundbeck produces and sells pharmaceutical products containing ‘Citalopram’ in all Member States and also in Norway and Switzerland, those countries being together defined as ‘the Territory’; | — | the third and fourth recitals mention that Alpharma has produced or purchased pharmaceutical products containing ‘Citalopram’ in ‘the Territory’, without Lundbeck’s consent; | — | the fifth and sixth recitals state that Alpharma’s products have been subjected to laboratory analyses by Lundbeck, the results of which gave Lundbeck substantial reason to believe that the production methods used to produce those products infringed its intellectual property rights; | — | the seventh recital recalls that, on 31 January 2002, Lundbeck filed a lawsuit with a United Kingdom court (‘the infringement action against Alpharma’) seeking an injunction ‘against Alpharma’s sale of products containing Citalopram for infringing Lundbeck’s intellectual property rights’; | — | the eighth recital states that Alpharma acknowledges that Lundbeck’s findings are correct and undertakes to refrain from marketing of ‘such products’; | — | The ninth and tenth recitals state that Lundbeck: | — | ‘has agreed to compensate Alpharma in order for Lundbeck to avoid patent litigation’, the outcome of which cannot be predicted with absolute certainty and which would be costly and time-consuming; | — | ‘in order to settle the dispute, [has] agreed to purchase all of Alpharma’s stock of products containing Citalopram and to compensate Alpharma for such products’. |
| 43 | V zvezi z vsebino sporazuma Alpharma je treba zlasti ugotoviti, da: | — | člen 1.1 določa, da podjetje Alpharma in njegove hčerinske družbe „razveljavijo, prenehajo in opustijo vsakršen uvoz, […] proizvodnjo […] ali prodajo farmacevtskih proizvodov z vsebnostjo Citaloprama na Ozemlju […] v [upoštevnem obdobju]“, in da družba Lundbeck umakne tožbo zaradi kršitev zoper podjetje Alpharma; | — | v isti točki je pojasnjeno, da se ne uporablja za escitalopram; | — | člen 1.2 določa, da „se bo podjetje Alpharma pri kakršni koli ugotovljeni kršitvi [člena 1.1] ali na predlog družbe Lundbeck […] prostovoljno podredilo začasni odredbi katerega koli pristojnega sodišča v kateri koli državi Ozemlja“, in da družba Lundbeck lahko doseže tako odredbo brez zagotovitve zavarovanja; | — | je v členu 1.3 pojasnjeno, da družba Lundbeck kot nadomestilo za obveznosti iz navedenega sporazuma in zaradi izognitve stroškom in trajanju spora podjetju Alpharma plača 12 milijonov USD, od tega 11 milijonov USD za proizvode podjetja Alpharma z vsebnostjo „Citaloprama“, in sicer v treh obrokih po štiri milijone USD, ki se nakažejo 31. marca 2002, 31. decembra 2002 oziroma 30. junija 2003; | — | člen 2.2 določa, da podjetje Alpharma najpozneje do 31. marca 2002 dostavi družbi Lundbeck celotno zalogo proizvodov z vsebnostjo „Citaloprama“, s katero razpolaga na ta datum, in sicer 9,4 milijona tablet, s katerimi že razpolaga ob sklenitvi sporazuma Alpharma, in 16 milijonov tablet, ki jih je naročilo. | 43 | As regards the body of the Alpharma agreement, it should be observed, in particular, that: | — | Article 1.1 stipulates that Alpharma and its affiliates ‘shall cancel, cease and desist from any importation, … production, … or sale of pharmaceutical products containing Citalopram in the Territory … during [the relevant period]’ and that Lundbeck is to withdraw the infringement action against Alpharma; | — | that same article specifies that it is not to apply to escitalopram; | — | Article 1.2 provides that ‘[i]n the event of any breach of the obligation set forth in Article 1.1 or at the request of Lundbeck, Alpharma … will voluntarily submit to an interim injunction by any competent court in any applicable country in the Territory’ and that Lundbeck is to be entitled to obtain such injunction without providing any kind of security; | — | Article 1.3 states that, as compensation for the obligations set out in that agreement and in order to avoid the costs and time of litigation, Lundbeck is to pay to Alpharma the sum of USD 12 million, of which USD 11 million is to be for Alpharma’s products containing ‘Citalopram’, in three instalments of USD 4 million to be paid on 31 March 2002, 31 December 2002 and 30 June 2003 respectively; | — | Article 2.2 establishes that, no later than 31 March 2002, Alpharma is to deliver to Lundbeck its entire current stock of products containing ‘Citalopram’, namely the 9.4 million tablets already in its possession at the time of conclusion of the Alpharma agreement and the 16 million tablets which it had ordered. |
| 44 | Priloga A vsebuje seznam 28 prijav v zvezi s pravicami intelektualne lastnine, ki jih je družba Lundbeck vložila pred njegovim podpisom, od katerih je bilo devetim že ugodeno na navedeni datum. Te pravice intelektualne lastnine so se nanašale na postopke za proizvodnjo AFU citalopram, zaščitenih s patenti za kristalizacijo in filmsko destilacijo. | 44 | Appendix A contains a list of 28 intellectual property rights applications lodged by Lundbeck before the signing of the agreement, including nine which had already been granted by that date. Those intellectual property rights related to the processes used to produce the citalopram API covered by the crystallisation and film distillation patents. |
| 45 | Sicer pa je treba pojasniti, da je sodišče Združenega kraljestva 2. maja 2002 izdalo sklep s soglasjem, ki določa, da se postopek s tožbo zaradi kršitev zoper podjetje Alpharma prekine zaradi sklenitve sporazuma med družbo Lundbeck in med drugim podjetjem Alpharma, po katerem zadnjenavedeno in njegove hčerinske družbe „razveljavijo, prenehajo in opustijo vsakršen uvoz, […] proizvodnjo […] ali prodajo v [državah članicah], na Norveškem in v Švici (v nadaljevanju: Upoštevna Ozemlja), farmacevtskih proizvodov z vsebnostjo citaloprama, proizvedenega po postopkih, prijavljenih s [patenti za kristalizacijo in filmsko destilacijo, ki so jih odobrili organi Združenega kraljestva], ali s kakršnim koli drugim enakovrednim patentom, odobrenim ali prijavljenim na Upoštevnih Ozemljih do 30. junija 2002“ (v nadaljevanju: sklep s soglasjem podjetja Alpharma). | 45 | Furthermore, it should be noted that on 2 May 2002 a United Kingdom court granted a consent order staying all proceedings in the infringement action against Alpharma because of the conclusion of the agreement between Lundbeck and, among others, Alpharma, according to which Alpharma and its affiliates agreed to ‘cancel, cease and desist from all importation ... production ... or sale, in [the Member States], Norway and Switzerland (‘the Relevant Territories’) of pharmaceutical products containing citalopram manufactured using processes claimed in [the crystallisation and film distillation patents granted by the United Kingdom authorities] or any equivalent patent granted or applied for in relation to the Relevant Territories … until 30 June 2003’ (‘the Alpharma consent order’). |
| D – Sporazum s podjetjem Ranbaxy | D – The agreement with Ranbaxy |
| 46 | Družba Lundbeck je sporazum s podjetjem Ranbaxy Laboratories podpisala 16. junija 2002 (v nadaljevanju: sporazum Ranbaxy) za obdobje 360 dni. Ta sporazum je bil z aneksom, podpisanim 19. februarja 2003 (v nadaljevanju: aneks Ranbaxy), podaljšan do 31. decembra 2003. Skupno je torej trajal od 16. junija 2002 do 31. decembra 2003 (v nadaljevanju: trajanje sporazuma Ranbaxy). | 46 | Lundbeck signed an agreement with Ranbaxy Laboratories on 16 June 2002 (‘the Ranbaxy agreement’), for a term of 360 days. Under an addendum signed on 19 February 2003 (‘the Ranbaxy addendum’), that agreement was extended until 31 December 2003. The total duration of the agreement is therefore from 16 June 2002 until 31 December 2003 (‘the term of the Ranbaxy agreement’). |
| 47 | V skladu s preambulo sporazuma Ranbaxy (v nadaljevanju: preambula sporazuma Ranbaxy): | — | je družba Ranbaxy Laboratories v Indiji prijavila dva patenta za postopek v zvezi s citalopramom in je proizvajala proizvode z vsebnostjo citaloprama z namenom trženja med drugim v EGP (druga in tretja uvodna izjava preambule sporazuma Ranbaxy ter priloga A k sporazumu Ranbaxy); | — | je družba Lundbeck ta citalopram laboratorijsko preizkusila in na podlagi tega ugotovila, da se z uporabljenimi postopki krši patent za amid in patent za jod, vendar zadnjenavedeni še ni bil odobren (glej točko 19 zgoraj), družba Ranbaxy Laboratoires pa izpodbija obstoj takih kršitev (od pete do osme uvodne izjave preambule sporazuma Ranbaxy); | — | sta družbi Lundbeck in Ranbaxy Laboratories sklenili sporazum zaradi izognitve patentnemu sporu, ki bi bil drag in dolgotrajen in katerega izida ni mogoče napovedati s popolno gotovostjo (deveta uvodna izjava preambule sporazuma Ranbaxy). | 47 | According to the preamble to the Ranbaxy agreement (‘the Ranbaxy preamble’): | — | Ranbaxy Laboratories filed two process patent applications in India relating to citalopram and manufactured medicinal products containing citalopram with the intention of marketing such products, in particular in the EEA (second and third recitals in the Ranbaxy preamble and Appendix A to the Ranbaxy agreement); | — | Lundbeck performed laboratory analyses on that citalopram and concluded that the processes used infringed the amide patent and the iodo patent, the latter not having been granted yet (see paragraph 19 above), whereas Ranbaxy Laboratories disputed the existence of such infringements (fifth to eighth recitals in the preamble); | — | Lundbeck and Ranbaxy Laboratories arrived at an agreement in order to avoid costly and time-consuming patent litigation, the outcome of which could not be predicted with absolute certainty (ninth recital in the Ranbaxy preamble). |
| 48 | Sporazum Ranbaxy med drugim določa: | — | „Družba Ranbaxy Laboratories pod pogoji [tega sporazuma] in pod pogojem plačila družbe Lundbeck ne uveljavlja nobene pravice iz prijave patenta [navedene v preambuli] ali iz katere koli proizvodne metode, ki jo uporablja družba Ranbaxy Laboratories, ter razveljavi, preneha in opusti proizvodnjo ali prodajo farmacevtskih proizvodov na tej podlagi [med drugim v EGP] med trajanjem tega sporazuma […]“ (člen 1.1 sporazuma Ranbaxy in člen 1.0 aneksa Ranbaxy); | — | družbi Ranbaxy Laboratories in Ranbaxy (UK) se „pri kršitvi obveznosti iz člena 1.1 ali na zahtevo družbe Lundbeck“ prostovoljno podredita začasnim odredbam, ki jih sprejmejo pristojna nacionalna sodišča, ne da bi bilo treba družbi Lundbeck deponirati kakršno koli zavarovanje ali se kakor koli zavezati, razen tistega kar izhaja iz tega sporazuma (člen 1.2 sporazuma Ranbaxy); | — | družba Lundbeck v zameno za sporazum med strankama plača družbi Ranbaxy Laboratories 9,5 milijona USD po obrokih, ki se razporedijo v upoštevnem obdobju (člen 1.3 sporazuma Ranbaxy in člen 2.0 aneksa Ranbaxy); | — | družba Lundbeck proda družbi Ranbaxy Laboratories ali družbi Ranbaxy (UK) tablete citaloprama s 40‑odstotnim popustom na tovarniško ceno, zato da jih ti dve lahko prodata na trgu Združenega kraljestva (člen 1.3 priloge B sporazuma Ranbaxy); | — | družbi Lundbeck in Ranbaxy Laboratories se zavezujeta, da druga zoper drugo ne bosta vložili tožb na podlagi nobenega od patentov, navedenih zgoraj v sporazumu (člen 1.4 sporazuma Ranbaxy). | 48 | According to the Ranbaxy agreement, in particular: | — | ‘Subject to the terms and conditions of this Agreement and subject to payment of the Settlement Amount by Lundbeck, [Ranbaxy Laboratories] shall not … claim any rights on the Patent Application [referred to in the preamble] or any production method used by [Ranbaxy Laboratories] and shall cancel, cease and desist from any manufacture or sale of pharmaceutical products based hereon [in particular in the EEA] during the term of this Agreement’ (Article 1.1 of the Ranbaxy agreement and Article 1.0 of the Ranbaxy addendum); | — | ‘In the event of any breach of the obligation set forth in Article 1.1 or at the request of Lundbeck’, Ranbaxy Laboratories and Ranbaxy (UK) would voluntarily submit to an interim injunction by any competent national court, without Lundbeck providing any kind of security or any undertaking other than the undertakings arising under that agreement (Article 1.2 of the Ranbaxy agreement); | — | in consideration of the agreement arrived at between the parties, Lundbeck was to pay to Ranbaxy Laboratories the sum of USD 9.5 million, in instalments over the relevant period (Article 1.3 of the Ranbaxy agreement and Article 2.0 of the Ranbaxy addendum); | — | Lundbeck was to sell citalopram tablets to Ranbaxy Laboratories or Ranbaxy (UK), with a discount of 40% on the ex-factory price, so that they could sell those tablets on the United Kingdom market (Article 1.3 of, and Appendix B to, the Ranbaxy agreement); | — | Lundbeck and Ranbaxy Laboratories undertook not to initiate legal proceedings against each other on the basis of any of the patents referred to earlier in the agreement itself (Article 1.4 of the Ranbaxy agreement). |
| IV – Ukrepanje Komisije v farmacevtskem sektorju in upravni postopek | IV – Steps taken by the Commission in the pharmaceutical sector and administrative procedure |
| 49 | Konkurrence‑ og Forbrugerstyrelsen (danski organ [za varstvo] konkurence in potrošnikov, v nadaljevanju: KFST) je Komisijo Evropskih skupnosti oktobra 2003 obvestil o obstoju zadevnih sporazumov. | 49 | In October 2003, the Commission of the European Communities was informed of the agreements at issue by the Konkurrence- og Forbrugerstyrelsen (the Danish authority for [the protection of] competition and consumers, ‘the KFST’). |
| 50 | Ker se je večina sporazumov nanašala na celoten EGP ali vsekakor na druge države članice kot Kraljevino Dansko, je bilo dogovorjeno, da bo Komisija preiskala njihovo skladnost s pravom konkurence, KFST pa tega vprašanja ne bo več obravnaval. | 50 | Since most of those agreements concerned the whole of the EEA or, at in any event, Member States other than the Kingdom of Denmark, it was agreed that the Commission would examine their compatibility with competition law, while the KFST would not pursue the matter. |
| 51 | Komisija je med letoma 2003 in 2006 pri družbi Lundbeck in drugih družbah iz farmacevtskega sektorja izvedla preglede v smislu člena 20(4) Uredbe Sveta (ES) št. 1/2003 z dne 16. decembra 2002 o izvajanju pravil konkurence iz členov 81 [ES] in 82 [ES] (UL, posebna izdaja v slovenščini, poglavje 8, zvezek 2, str. 205). Družbi Lundbeck in še neki drugi družbi je poslala tudi zahteve za informacije v smislu člena 18(2) navedene uredbe. | 51 | Between 2003 and 2006, the Commission carried out inspections within the meaning of Article 20(4) of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles [101 TFEU] and [102 TFEU] (OJ 2003 L 1, p. 1) at the premises of Lundbeck and other companies active in the pharmaceutical sector. It also sent Lundbeck and another company requests for information within the meaning of Article 18(2) of that regulation. |
| 52 | Komisija je 15. januarja 2008 v skladu s členom 17 Uredbe št. 1/2003 sprejela sklep o uvedbi preiskave v farmacevtskem sektorju (zadeva COMP/D2/39514). Edini člen tega sklepa določa, da se bo preiskava nanašala na uvajanje inovativnih in generičnih zdravil za uporabo v humani medicini na trg. | 52 | On 15 January 2008, the Commission adopted the decision initiating an inquiry into the pharmaceutical sector, pursuant to Article 17 of Regulation No 1/2003 (Case No COMP/D2/39514). The single article of that decision stated that the inquiry would relate to the introduction of innovative and generic medicinal products for human consumption on to the market. |
| 53 | Komisija je 8. julija 2009 sprejela sporočilo s povzetkom poročila njene preiskave farmacevtskega sektorja. To sporočilo je v tehnični prilogi vsebovalo celotno različico navedenega poročila o preiskavi v obliki delovnega dokumenta Komisije, razpoložljivega izključno v angleščini. | 53 | On 8 July 2009, the Commission adopted a communication summarising its report of the inquiry into the pharmaceutical sector. That communication included, in a technical annex, the full version of the inquiry report, in the form of a Commission working document, available only in English. |
| 54 | Komisija je 7. januarja 2010 uvedla formalni postopek zoper družbo Lundbeck. | 54 | On 7 January 2010, the Commission opened formal proceedings against Lundbeck. |
| 55 | Komisija je med letom 2010 in v prvem polletju leta 2011 družbi Lundbeck in zlasti družbam, ki so bile stranke spornih sporazumov, poslala zahteve za informacije. | 55 | In 2010 and the first half of 2011, the Commission sent requests for information to Lundbeck and to the other companies which were parties to the agreements at issue. |
| 56 | Komisija je 24. julija 2012 uvedla postopek zoper družbe, ki so bile stranke spornih sporazumov, in jim poslala obvestilo o ugotovitvah o možnih kršitvah, ter zoper družbo Lundbeck. | 56 | On 24 July 2012, the Commission opened proceedings against the companies which were parties to the agreements at issue and sent them, and Lundbeck, a statement of objections. |
| 57 | Vsi naslovniki tega obvestila, ki so to zahtevali, so bili zaslišani na zaslišanjih 14. in 15. marca 2013. | 57 | All the addressees of that statement of objections who had requested a hearing were heard at the hearings on 14 and 15 March 2013. |
| 58 | Komisija je 12. aprila 2013 naslovnikom obvestila o ugotovitvah o možnih kršitvah poslala dopis o ugotovljenih dejstvih. | 58 | On 12 April 2013, the Commission sent a letter of facts to all the addressees of the statement of objections. |
| 59 | Pooblaščenec za zaslišanje je svoje končno poročilo izdal 17. junija 2013. | 59 | The hearing officer issued his final report on 17 June 2013. |
| 60 | Komisija je 19. junija 2013 sprejela Sklep C(2013) 3803 final v zvezi s postopkom na podlagi člena 101 [PDEU] in člena 53 Sporazuma o Evropskem gospodarske prostoru (zadeva AT/39226 – LUNDBECK, v nadaljevanju: izpodbijani sklep). | 60 | On 19 June 2013, the Commission adopted Decision C(2013) 3803 final relating to a proceeding under Article 101 [TFEU] and Article 53 of the EEA Agreement (Case AT.39226 — Lundbeck) (‘the contested decision’). |
| V – Izpodbijani sklep | V – Contested decision |
| 61 | Komisija je z izpodbijanim sklepom odločila, da sporni sporazumi pomenijo omejevanje konkurence „zaradi cilja“ v smislu člena 101(1) PDEU in člena 53(1) Sporazuma EGP (člen 1(1) izpodbijanega sklepa). | 61 | By the contested decision, the Commission considered that the agreements at issue constituted restrictions of competition ‘by object’ within the meaning of Article 101(1) TFEU and Article 53(1) of the EEA Agreement (Article 1(1) of the contested decision). |
| 62 | Oba sporazuma med podjetjem Merck (GUK) in družbo Lundbeck sta pomenila enotno in nadaljevano kršitev, ki je trajala od 24. januarja 2002 do 1. novembra 2003. | 62 | The two agreements between Merck (GUK) and Lundbeck were considered to have constituted a single and continuous infringement lasting from 24 January 2002 until 1 November 2003. |
| 63 | Iz povzetka v točkah 824 in 874 obrazložitve izpodbijanega sklepa izhaja, da se je Komisija v zvezi s tem oprla zlasti na te elemente: | — | družba Lundbeck in podjetje Merck (GUK) sta bila v času sklenitve navedenih sporazumov vsaj potencialna konkurenta v Združenem kraljestvu in EGP ter dejanska konkurenta v Združenem kraljestvu pred drugim podaljšanjem sporazuma GUK za Združeno kraljestvo; | — | družba Lundbeck je v skladu z navedenimi sporazumi na podjetje Merck (GUK) prenesla veliko vrednost; | — | ta prenos vrednosti je bil povezan s tem, da je podjetje Merck (GUK) sprejelo omejitve za vstop na trge iz navedenih sporazumov, zlasti z zavezo, da ne bo prodajalo citaloprama družbe Natco ali katerega koli drugega generičnega citaloprama v Združenem kraljestvu in EGP v upoštevnem času trajanja teh sporazumov; | — | ta prenos vrednosti je približno ustrezal pričakovanemu dobičku podjetja Merck (GUK), če bi uspešno vstopilo na trg; | — | družba Lundbeck ni mogla doseči takih omejitev z uveljavljanjem patentiranih postopkov, ker so obveznosti podjetja Merck (GUK) na podlagi teh sporazumov presegale pravice, ki jih imajo imetniki patentiranih postopkov; | — | navedeni sporazumi niso določali nobene zaveze družbe Lundbeck, da zoper podjetje Merck (GUK) ne bo vložila tožb zaradi kršitev, če bi to po poteku teh sporazumov vstopilo na trg s citalopramom. | 63 | As is apparent from the summary set out in recitals 824 and 874 of the contested decision, the Commission relied, in particular, on the following factors in that respect: | — | at the time of concluding those agreements, Lundbeck and Merck (GUK) were at least potential competitors in the United Kingdom and in the EEA and actual competitors in the United Kingdom before the second extension of the GUK United Kingdom agreement; | — | Lundbeck transferred significant value to Merck (GUK) pursuant to those agreements; | — | that transfer of value was linked to the acceptance by Merck (GUK) of the limitations on market entry set out in those agreements, notably its commitment not to sell Natco’s citalopram or any other generic citalopram in the United Kingdom and in the EEA during the relevant term of those agreements; | — | that transferred value corresponded approximately to the profits Merck (GUK) expected to make if it had successfully entered the market; | — | Lundbeck could not have obtained those limitations on entry through enforcement of its process patents, since the obligations on Merck (GUK) under those agreements went beyond the rights granted to holders of process patents; | — | those agreements contained no commitment from Lundbeck to refrain from bringing infringement proceedings against Merck (GUK) if the latter entered the market with generic citalopram after the expiry of the agreements. |
| 64 | Oba sporazuma med podjetjem Arrow in družbo Lundbeck sta pomenila enotno in nadaljevano kršitev, ki je trajala od 24. januarja 2002 do 20. oktobra 2003. | 64 | The two agreements between Arrow and Lundbeck were considered to have constituted a single and continuous infringement lasting from 24 January 2002 until 20 October 2003. |
| 65 | Iz povzetkov v točkah 962 in 1013 obrazložitve izpodbijanega sklepa v zvezi s sporazumom Arrow UK oziroma danskim sporazumom Arrow izhaja, da se je Komisija oprla zlasti na te elemente: | — | družba Lundbeck in podjetje Arrow sta bila v času sklenitve navedenih sporazumov vsaj potencialna konkurenta v Združenem kraljestvu in na Danskem; | — | družba Lundbeck je v skladu z navedenimi sporazumi na podjetje Arrow prenesla veliko vrednost; | — | ta prenos vrednosti je bil povezan s tem, da je podjetje Arrow sprejelo omejitve za vstop na trg citaloprama v Združenem kraljestvu in na Danskem iz navedenih sporazumov, zlasti z zavezo podjetja Arrow, da v upoštevnem času trajanja teh sporazumov ne bo prodajalo generičnega citaloprama, za katerega družba Lundbeck meni, da krši njegove patente; | — | ta prenos vrednosti je približno ustrezal pričakovanemu dobičku podjetja Arrow, če bi uspešno vstopilo na trg; | — | družba Lundbeck takih omejitev ne bi mogla doseči z uveljavljanjem svojih novih patentov, ker so obveznosti podjetja Arrow na podlagi teh sporazumov presegale pravice, ki jih imajo imetniki patentiranih postopkov; | — | navedeni sporazumi niso določali nobene zaveze družbe Lundbeck, da zoper podjetje Arrow ne bo vložila tožb zaradi kršitev, če bi to po poteku enega ali drugega sporazuma vstopilo na trg z generičnim citalopramom v Združenem kraljestvu ali na Danskem. | 65 | As is apparent from the summaries in recitals 962 and 1013 of the contested decision, relating to Arrow UK agreement and the Arrow Danish agreement respectively, the Commission relied, in particular, on the following factors: | — | at the time those agreements were concluded, Lundbeck and Arrow were at least potential competitors in the United Kingdom and in Denmark; | — | Lundbeck transferred significant value to Arrow pursuant to those agreements; | — | that transfer of value was linked to Arrow’s acceptance of the limitations on its entry to the citalopram market in the United Kingdom and in Denmark contained in those agreements, in particular Arrow’s commitment not to sell generic citalopram, which Lundbeck regarded as infringing its patents, during the respective terms of those agreements; | — | that transferred value corresponded approximately to the profit that Arrow expected to make if it had successfully entered the market; | — | Lundbeck could not have obtained those limitations through enforcement of its new patents, since the obligations on Arrow under those agreements went beyond the rights granted to holders of process patents; | — | those agreements contained no commitment from Lundbeck to refrain from bringing infringement proceedings against Arrow if the latter entered the United Kingdom or Danish markets with generic citalopram after the expiry of one of those agreements. |
| 66 | V zvezi s sporazumom Alpharma se je Komisija, kot izhaja iz povzetka v točki 1087 obrazložitve izpodbijanega sklepa, oprla zlasti na te elemente: | — | družba Lundbeck in podjetje Alpharma sta bili v času sklenitve navedenega sporazuma vsaj potencialna konkurenta v več državah EGP; | — | družba Lundbeck je v skladu z navedenim sporazumom na podjetje Alpharma prenesla veliko vrednost; | — | ta prenos vrednosti je bil povezan s tem, da je podjetje Alpharma sprejelo omejitve za vstop na trg iz navedenega sporazuma, zlasti z zavezo podjetja Alpharma, da v upoštevnem času ne bo prodajalo generičnega citaloprama v EGP; | — | ta prenos vrednosti je približno ustrezal pričakovanemu dobičku podjetja Alpharma, če bi uspešno vstopilo na trg; | — | družba Lundbeck takih omejitev ne bi mogla doseči z uveljavljanjem svojih patentov za kristalizacijo in filmsko destilacijo, ker so obveznosti podjetja Alpharma na podlagi tega sporazuma presegale pravice, ki jih imajo imetniki patentiranih postopkov; | — | sporazum ni določal nobene zaveze družbe Lundbeck, da zoper podjetje Alpharma ne bo vložila tožb zaradi kršitev, če bi to po njegovem poteku vstopila na trg z generičnim citalopramom. | 66 | As regards the Alpharma agreement, as stated in the summary set out in recital 1087 of the contested decision, the Commission relied, in particular, on the following factors: | — | at the time when they concluded that agreement, Lundbeck and Alpharma were at least potential competitors in a number of EEA countries; | — | Lundbeck transferred significant value to Alpharma pursuant to that agreement; | — | that transfer of value was linked to Alpharma’s acceptance of the limitations on entry to the market contained in that agreement, and in particular to Alpharma’s commitment not to sell any generic citalopram in the EEA during the relevant period; | — | that transferred value corresponded approximately to the profit Alpharma expected to make if it had successfully entered the market; | — | Lundbeck could not have obtained those limitations through the application of the crystallisation and film distillation patents, since the obligations placed on Alpharma under that agreement went beyond the rights granted to holders of process patents; | — | the agreement contained no commitment from Lundbeck to refrain from bringing infringement proceedings against Alpharma if the latter entered the market with generic citalopram after the expiry of the agreement. |
| 67 | V zvezi s sporazumom Ranbaxy se je Komisija, kot izhaja iz povzetka v točki 1174 obrazložitve izpodbijanega sklepa, oprla zlasti na te elemente: | — | družba Lundbeck in podjetje Ranbaxy sta bila v času sklenitve navedenega sporazuma vsaj potencialna konkurenta v EGP; | — | družba Lundbeck je v skladu z navedenim sporazumom na podjetje Ranbaxy prenesla veliko vrednost; | — | ta prenos vrednosti je bil povezan s tem, da je podjetje Ranbaxy sprejelo omejitve za vstop na trg iz navedenega sporazuma, zlasti z zavezo podjetja Ranbaxy, da v upoštevnem času ne bo proizvajalo niti prodajalo svojega citaloprama v EGP, bodisi prek svojih hčerinskih družb bodisi pred tretjih oseb; | — | ta prenos vrednosti je precej presegal pričakovani dobiček podjetja Ranbaxy s prodajo do tedaj proizvedenega generičnega citaloprama; | — | družba Lundbeck takih omejitev ne bi mogla doseči z uveljavljanjem svojih patentiranih postopkov, ker so obveznosti podjetja Ranbaxy na podlagi tega sporazuma presegale pravice, ki jih ima imetnik patentiranih postopkov; | — | sporazum ni določal nobene zaveze družbe Lundbeck, da zoper podjetje Ranbaxy ne bo vložila tožb zaradi kršitev, če bi to po njegovem poteku vstopilo na trg z generičnim citalopramom. | 67 | As regards the Ranbaxy agreement, as is apparent from the summary set out in recital 1174 of the contested decision, the Commission relied, in particular, on the following factors: | — | at the time of concluding that agreement, Lundbeck and Ranbaxy were at least potential competitors in the EEA; | — | Lundbeck transferred significant value to Ranbaxy pursuant to that agreement; | — | that transfer of value was linked to Ranbaxy’s acceptance of the limitations on its entry to the market set out in that agreement, and in particular to Ranbaxy’s commitment not to manufacture or sell citalopram in the EEA during the relevant period, whether through its own subsidiaries or via third parties; | — | that transferred value considerably exceeded the profit that Ranbaxy could have expected to make by selling the generic citalopram it had manufactured until then; | — | Lundbeck could not have obtained those limitations by enforcing its process patents, since the obligations on Ranbaxy under that agreement went beyond the rights granted to holders of process patents; | — | that agreement contained no commitment from Lundbeck to refrain from bringing infringement proceedings against Ranbaxy if the latter entered the market with its generic citalopram after the expiry of the agreement. |
| 68 | Komisija je vsem strankam spornih sporazumov naložila tudi globe. Pri tem je uporabila Smernice o načinu določanja glob, naloženih v skladu s členom 23(2)(a) Uredbe št. 1/2003 (UL 2006, C 210, str. 2, v nadaljevanju: smernice iz leta 2006). Komisija je v zvezi z družbo Lundbeck ravnala v skladu s splošno metodologijo iz smernic iz leta 2006, ki temelji na vrednosti prodaje zadevnega proizvoda, ki jo je dosegel vsak od udeležencev omejevalnega sporazuma (točke od 1316 do 1358 obrazložitve izpodbijanega sklepa). Nasprotno pa je v zvezi z drugimi strankami spornih sporazumov, torej generičnimi podjetji, uporabila možnost iz točke 37 navedenih smernic, da ne uporabi te metodologije zaradi posebnosti zadeve v zvezi s temi strankami (točka 1359 obrazložitve izpodbijanega sklepa). | 68 | The Commission also imposed fines on all the parties to the agreements at issue. To that end, it applied the Guidelines on the method of setting fines imposed pursuant to Article 23(2)(a) of Regulation No 1/2003 (OJ 2006 C 210, p. 2) (‘the 2006 Guidelines’). In Lundbeck’s case, the Commission followed the general methodology described in the 2006 Guidelines, based on the value of sales of the relevant product made by each participant in an infringement (recitals 1316 to 1358 of the contested decision). In the case of the other parties to those agreements however, namely the generic undertakings, it made use of the possibility, provided for in point 37 of those Guidelines, to depart from that methodology, in view of the particularities of the case so far as those parties were concerned (recital 1359 of the contested decision). |
| 69 | Komisija je tako v zvezi z navedenimi strankami sporazumov menila, da je treba pri določitvi osnovnega zneska globe zaradi zagotovitve zadostnega odvračilnega učinka te globe upoštevati višino zneskov, ki jih je družba Lundbeck prenesla v skladu s spornimi sporazumi, brez razlikovanja med kršitvami glede na značaj ali geografsko območje teh kršitev ali glede na tržne deleže zadevnih podjetij, kar so dejavniki, ki so bili v izpodbijanem sklepu obravnavani samo zaradi izčrpnosti (točka 1361 obrazložitve izpodbijanega sklepa). | 69 | Thus, as regards the parties to the agreements at issue other than Lundbeck, the Commission considered that, in order to determine the basic amount of the fine and to ensure that the fine would have a sufficient deterrent effect, it was appropriate to take account of the value of the sums transferred to them by Lundbeck pursuant to those agreements, without differentiating between the infringements on the basis of their nature or geographic scope, or on the basis of the market share of the undertakings concerned, those factors being addressed only for the sake of completeness (recital 1361 of the contested decision). |
| 70 | Nasprotno pa je Komisija v zvezi z družbo Lundbeck uporabila splošno metodo, opisano v svojih smernicah, in se oprla na vrednost prodaje na zadevnih trgih. Ker se je prodaja citaloprama družbe Lundbeck v času trajanja spornih sporazumov precej zmanjšala, in ker ti niso zajemali celotnega poslovnega leta, je Komisija izračunala povprečno letno vrednost prodaje. Pri tem je najprej izračunala povprečno mesečno vrednost prodaje citaloprama družbe Lundbeck med trajanjem vsakega spornega sporazuma, nato pa to vrednost pomnožila z dvanajst (točka 1326 obrazložitve in opomba 2215 izpodbijanega sklepa). | 70 | As regards Lundbeck, the Commission applied the general method described in the 2006 Guidelines, taking as a basis the value of sales on the relevant market. Since Lundbeck’s sales of citalopram had significantly decreased during the course of the agreements, and since the agreements did not cover a full business year, the Commission calculated an average annual value of sales. For that purpose, it first calculated the monthly average value of Lundbeck’s sales of citalopram during the term of each of the agreements at issue, then multiplied that value by 12 (recital 1326 and footnote No 2215 of the contested decision). |
| 71 | Komisija je družbi Lundbeck naložila tudi štiri ločene globe, glede na to, da so zaradi šestih spornih sporazumov nastale štiri ločene kršitve, ker je zaradi dveh sporazumov med družbo Lundbeck in podjetjem Merck (GUK) nastala ena, enotna in nadaljevana kršitev, tako kot pri dveh sporazumih med družbo Lundbeck in podjetjem Arrow. Komisija je, da bi se izognila nesorazmerni globi, ob upoštevanju okoliščin zadeve uporabila korekcijski faktor navzdol, ki temelji na metodi, ki odraža geografsko in časovno prekrivanje različnih kršitev (točka 1329 obrazložitve izpodbijanega sklepa). Posledica te metode je bilo 15‑odstotno znižanje za vsako kršitev, pri kateri je bilo ugotovljeno prekrivanje (opomba 2218 izpodbijanega sklepa). | 71 | The Commission also imposed four separate fines on Lundbeck, since the six agreements at issue were regarded as giving rise to four separate infringements, in so far as the two agreements between Lundbeck and Merck (GUK) gave rise to a single and continuous infringement, as did the two agreements between Lundbeck and Arrow. In order to avoid arriving at a disproportionate fine, the Commission nevertheless applied a negative weighting in the light of the circumstances of the case, based on a method reflecting the geographic and temporal overlaps between the various infringements (recital 1329 of the contested decision). That method resulted in a reduction of 15% for each infringement where overlaps were found (footnote No 2218 of the contested decision). |
| 72 | Komisija je zaradi teže ugotovljenih kršitev, ki jih je opredelila kot „resne“, ker so zajemale izključitev s trga, zaradi velikega tržnega deleža družbe Lundbeck za proizvode, na katere so se nanašale te kršitve, zelo velikega geografskega področja uporabe spornih sporazumov in tega, da so bili vsi ti sporazumi izvedeni, menila, da je treba delež vrednosti prodaje določiti na 11 % za kršitve, katerih geografski obseg je bil celoten EGP, in 10 % za druge (točki 1331 in 1332 obrazložitve izpodbijanega sklepa). | 72 | In the light of the gravity of the infringements found, which the Commission classified as ‘serious’, since they entailed market exclusion; Lundbeck’s high market share of the product to which the infringements related; the wide geographic scope of the agreements at issue; and the fact that all the agreements had been implemented, the Commission considered that the proportion of the value of sales to be applied should be set at 11% for the infringements where the geographic scope was the entire EEA and 10% for the other infringements (recitals 1331 and 1332 of the contested decision). |
| 73 | Komisija je na podlagi točke 25 smernic iz leta 2006 zaradi zagotovitve zadostne odvračilnosti glob v zvezi s tem zneskom uporabila množitelj zaradi upoštevanja trajanja kršitev (točke od 1334 do 1337 obrazložitve izpodbijanega sklepa) in 10 % višji znesek za prvo storjeno kršitev, torej tisto v zvezi s sporazumi s podjetjem Arrow (točka 1340 obrazložitve izpodbijanega sklepa). | 73 | The Commission applied a multiplier to that amount to take account of the duration of the infringements (recitals 1334 to 1337 of the contested decision) and an additional amount of 10% for the first infringement committed, that is to say, the infringement concerning the agreements with Arrow, in application of point 25 of the 2006 Guidelines, in order to ensure that the fines would be sufficiently deterrent (recital 1340 of the contested decision). |
| 74 | Komisija pa je zaradi trajanja celotne preiskave znesek naloženih glob vsem naslovnikom izpodbijanega sklepa znižala za 10 % (točki 1349 in 1380 obrazložitve izpodbijanega sklepa). | 74 | In view of the total length of the investigation, the Commission nevertheless granted a reduction of 10% of the amount of the fines imposed on all the addressees of the contested decision (recitals 1349 and 1380 of the contested decision). |
| 75 | Komisija je na podlagi navedenih preudarkov, in ker je sporazum GUK za Združeno kraljestvo podpisala družba Lundbeck Ltd, družbi Lundbeck A/S naložila skupno globo v višini 93.766.000 EUR, od tega 5.306.000 EUR solidarno z družbo Lundbeck Ltd, ki je sestavljena tako (točki 1238 in 1358 obrazložitve ter člen 2 izpodbijanega sklepa): | — | 19.893.000 EUR za sporazuma s podjetjem Merck (GUK), od tega 5.306.000 EUR solidarno z družbo Lundbeck Ltd; | — | 12.951.000 EUR za sporazuma s podjetjem Arrow; | — | 31.968.000 EUR za sporazum s podjetjem Alpharma; | — | 28.954.000 EUR za sporazum s podjetjem Ranbaxy. | 75 | On the basis of those considerations, and taking into account the fact that the GUK United Kingdom agreement had been signed by Lundbeck Ltd, the Commission imposed a total fine of EUR 93766000 on Lundbeck A/S, of which EUR 5306000 jointly and severally with Lundbeck Ltd, composed as follows (recitals 1238 and 1358 and Article 2 of the contested decision): | — | EUR 19893000 for the agreements concluded with Merck (GUK), of which EUR 5306000 jointly and severally with Lundbeck Ltd; | — | EUR 12951000 for the agreements concluded with Arrow; | — | EUR 31968000 for the agreement concluded with Alpharma; and | — | EUR 28954000 for the agreement concluded with Ranbaxy. |
| Postopek in predlogi strank | Procedure and forms of order sought |
| 76 | Tožeči stranki Lundbeck A/S in Lundbeck Ltd sta 30. avgusta 2013 v sodnem tajništvu Splošnega sodišča vložili to tožbo. | 76 | By application lodged at the Court Registry on 30 August 2013, the applicants, Lundbeck A/S and Lundbeck Ltd, brought the present action. |
| 77 | Združenju European Federation of Pharmaceutical Industries and Associations (v nadaljevanju: združenje EFPIA ali intervenient) je bila s sklepom predsednika devetega senata z dne 20. maja 2014 dovoljena intervencija v tem postopku v podporo stališčem tožečih strank. | 77 | By order of the President of the Ninth Chamber of 20 May 2014, the European Federation of Pharmaceutical Industries and Associations (‘EFPIA’ or ‘the intervener’) was granted leave to intervene in the present proceedings, in support of the form of order sought by the applicants. |
| 78 | Glavne stranke so bile v okviru ukrepov procesnega vodstva iz člena 64 Poslovnika Splošnega sodišča z dne 2. maja 1991 pozvane, naj se v okviru svojih stališč o intervencijski vlogi združenja EFPIA pisno opredelijo do morebitnih posledic sodbe z dne 11. septembra 2014, CB/Komisija (C‑67/13 P, ZOdl., EU:C:2014:2204), za obravnavano zadevo. | 78 | In the context of measures of organisation of procedure provided for in Article 64 of the Rules of Procedure of the General Court of 2 May 1991, the main parties were invited to comment in writing, in the context of their observations on EFPIA’s statement in intervention, on the possible consequences for the present case of the judgment of 11 September 2014 in CB v Commission (C‑67/13 P, ECR, EU:C:2014:2204). |
| 79 | Glavne stranke so svoja stališča poslale v zahtevanem roku z vlogami, ki so jih v sodnem tajništvu Splošnega sodišča vložile 15. januarja 2015. | 79 | The main parties submitted their observations within the prescribed period, by pleadings lodged at the Court Registry on 15 January 2015. |
| 80 | Pisni del postopka je bil končan istega dne. | 80 | The written stage of the procedure was closed on the same day. |
| 81 | Splošno sodišče (deveti senat) je na predlog sodnika poročevalca odločilo, da začne ustni postopek, ter v okviru ukrepov procesnega vodstva iz člena 89 svojega poslovnika strankam zastavilo vprašanja in jih pozvalo, naj nanje odgovorijo pisno. | 81 | On a proposal from the Judge-Rapporteur, the Court (Ninth Chamber) decided to open the oral part of the procedure and, by way of measures of organisation of procedure provided for in Article 89 of its Rules of Procedure, put a number of questions to the parties, to be answered in writing. |
| 82 | Stranke so na navedena vprašanja odgovorile v zahtevanem roku z vlogami, ki so jih v sodnem tajništvu Splošnega sodišča vložile 30. oktobra 2015. | 82 | The parties answered those questions within the prescribed period, by pleadings received at the Court Registry on 30 October 2015. |
| 83 | Stranke so na obravnavi 26. novembra 2015 podale ustne navedbe in odgovorile na ustna vprašanja Splošnega sodišča. | 83 | The parties presented oral argument and replied to the questions put by the Court at the hearing on 26 November 2015. |
| 84 | Tožeči stranki Splošnemu sodišču predlagata, naj: | — | s pripravljalnim ukrepom naloži Komisiji predložitev nezakritih različic njenega dopisovanja s KFST; | — | izpodbijani sklep razglasi za ničen; | — | podredno, odpravi globe, ki so bile tožečima strankama naložene na podlagi tega sklepa; | — | še bolj podredno, bistveno zniža navedene globe; | — | Komisiji vsekakor naloži plačilo stroškov tega postopka; | — | sprejme vse druge ukrepe, za katere meni, da so ustrezni. | 84 | The applicants claim that the Court should: | — | adopt a measure of inquiry requesting the Commission to produce unredacted versions of its correspondence with the KFST; | — | annul the contested decision; | — | in the alternative, annul the fines imposed on the applicants pursuant to that decision; | — | in the further alternative, substantially reduce those fines; | — | in any event, order the Commission to pay the costs incurred by the applicants; | — | take any other measure that the Court may deem appropriate. |
| 85 | Komisija predlaga Splošnemu sodišču, naj: | — | tožbo zavrne kot neutemeljeno; | — | tožečima strankama naloži plačilo stroškov, razen stroškov intervenienta; | — | intervenientu naloži plačilo njegovih stroškov. | 85 | The Commission contends that the Court should: | — | dismiss the action as unfounded; | — | order the applicants to pay the costs, with the exception of those incurred by the intervener; | — | order the intervener to bear its own costs. |
| 86 | Intervenient Splošnemu sodišču predlaga, naj: | — | izpodbijani sklep v delu, v katerem se nanaša na tožeči stranki, razglasi za ničen; | — | Komisiji naloži plačilo stroškov, ki jih je priglasil intervenient. | 86 | The intervener claims that the Court should: | — | annul the contested decision in so far as it concerns the applicants; | — | order the Commission to pay the costs incurred by the intervener. |
| 87 | V zvezi s predlogom tožečih strank, da naj Splošno sodišče s pripravljalnim ukrepom naloži Komisiji predložitev nezakritih različic dopisovanja s KFST je treba ugotoviti, da sta tožeči stranki po spontani predložitvi teh dokumentov v okviru tega postopka na obravnavi potrdili, da z njim ne želita več vztrajati. | 87 | As regards the applicants’ head of claim asking the Court to adopt a measure of inquiry requesting the Commission to produce unredacted versions of its correspondence with the KFST, it must be noted that, following the spontaneous communication of those documents in the present proceedings, the applicants confirmed at the hearing that they did not wish to maintain that head of claim. |
| Pravo | Law |
| 88 | Tožeči stranki v utemeljitev tožbe navajata deset tožbenih razlogov. Obravnavati jih je treba po vrstnem redu kot sta jih navedli. | 88 | The applicants raise ten pleas in law in support of their action. It is appropriate to examine those pleas in the order in which they have been set out by the applicants. |
| I – Prvi tožbeni razlog: napačna uporaba prava in presoja, ker se v izpodbijanem sklepu ugotavlja, da so bila generična podjetja in družba Lundbeck v času sklenitve spornih sporazumov vsaj potencialni konkurenti | I – The first plea in law, alleging errors of law and of assessment in that the contested decision considered that the generic undertakings and Lundbeck were at least potential competitors at the time the agreements at issue were concluded |
| 89 | Tožeči stranki navajata, da se v izpodbijanem sklepu pri ugotavljanju, ali se z določenim sporazumom omejuje potencialna konkurenca, napačno razlaga upoštevna sodna praksa, po kateri morajo brez sporazuma obstajati dejanske in konkretne možnosti za vstop na trg, in menita, da Komisija ni upoštevala bistvenih dejstev v zvezi s tem. | 89 | The applicants submit that the contested decision misinterprets the relevant case-law on establishing whether an agreement restricts potential competition, which presupposes the existence of real concrete possibilities of entering the market in the absence of the agreement, and they maintain that the Commission disregarded essential facts in that respect. |
| 90 | Pred obravnavanjem trditev tožečih strank je treba na kratko spomniti na upoštevno sodno prakso in na pristop Komisije iz izpodbijanega sklepa v zvezi s potencialno konkurenco med družbo Lundbeck in generičnimi podjetji. | 90 | Before examining the applicants’ arguments, it is appropriate to give a brief summary of the relevant case-law and of the approach taken by the Commission in the contested decision as regards the potential competition between Lundbeck and the generic undertakings. |
| A – Analiza v zvezi s potencialno konkurenco v izpodbijanem sklepu | A – Analysis relating to potential competition in the contested decision |
| 91 | Komisija je v točkah od 615 do 620 obrazložitve izpodbijanega sklepa obravnavala posebnosti farmacevtskega sektorja in razlikovala med dvema fazama, v katerih lahko nastane potencialna konkurenca v tem sektorju. | 91 | In recitals 615 to 620 of the contested decision, the Commission examined the specific characteristics of the pharmaceutical sector and identified two phases in which potential competition could occur in that sector. |
| 92 | Prva faza se lahko začne več let pred potekom patenta za AFU, ko generični proizvajalci, ki želijo dati na trg generično različico zadevnega zdravila, začnejo razvijati proizvodne postopke za uspešno izdelavo proizvoda, ki izpolnjuje zakonodajne zahteve. V drugi fazi mora nato generično podjetje zaradi priprave na dejanski vstop na trg pridobiti dovoljenje za promet (v nadaljevanju: DZP) v smislu Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani (UL, posebna izdaja v slovenščini, poglavje 13, zvezek 27, str. 69), naročiti tablete pri enem ali več generičnih proizvajalcih ali jih sâmo proizvesti, ter najti distributerje ali vzpostaviti lastno distribucijsko mrežo, torej izvesti več predhodnih ukrepov, brez katerih nikoli ne bi bilo dejanske konkurence na trgu. | 92 | The first phase may begin several years before the expiry of the patent on an API, when generic producers that want to launch a generic version of the medicinal product concerned begin developing viable production processes leading to a product that meets regulatory requirements. Next, in the second phase, in order to prepare for actual market entry, a generic undertaking must apply for marketing authorisations (‘MAs’) pursuant to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, p. 67), order tablets from one or more generic producers or produce them itself and find distributors or set up its own distribution network, that is to say, it must take a series of preliminary steps, without which there would never be any effective competition on the market. |
| 93 | Zaradi prihodnjega poteka patenta za AFU torej nastane dinamičen konkurenčni proces, v katerem različna podjetja, ki proizvajajo generična zdravila, konkurirajo za prvo mesto pri vstopu na trg. Prvo od teh podjetij, ki vstopi na trg, lahko namreč ustvari velik dobiček dokler se konkurenca ne okrepi in se cene občutno znižajo. Zato so ta podjetja pripravljena izvesti precejšnje naložbe in prevzeti velika tveganja, zato da prva vstopijo na trg zadevnega proizvoda nemudoma po poteku patenta za AFU. | 93 | The impending expiry of the patent on an API therefore generates a dynamic competitive process, during which the various undertakings producing generic medicinal products compete to be the first to enter the market. The first of those undertakings to enter the market can generate significant profits, before competition intensifies and prices fall drastically. That is why those undertakings are willing to make considerable investments and take significant risks in order to be the first to enter the market for the product concerned once the patent on the API concerned expires. |
| 94 | Podjetja, ki proizvajajo generična zdravila ali ki jih nameravajo prodajati so v okviru teh dveh faz potencialne konkurence pogosto soočena z vprašanji patentnega prava in prava intelektualne lastnine. Vendar načeloma najdejo način, da se izognejo kršitvi obstoječih patentov, kot so patentirani postopki. V zvezi s tem imajo namreč več možnosti, na primer možnost zahtevati ugotovitev, da kršitve ni, ali „sprostiti pot“ s seznanitvijo proizvajalca originalnih zdravil o nameravanem vstopu na trg. Prav tako lahko te proizvode dajo na trg „s tveganjem“ in se zoper potencialne očitke o kršitvah branijo ali v zvezi s tem vložijo nasprotno tožbo za izpodbijanje veljavnosti patentov, na katere se opira tožba zaradi kršitev. Nazadnje lahko tudi sodelujejo s svojim proizvajalcem AFU pri spremembi proizvodnega postopka ali zmanjšanju tveganja kršitve, ali pa spremenijo proizvajalca AFU, da se izognejo temu tveganju. | 94 | In those two phases of potential competition, undertakings which produce generic medicinal products or which intend to sell them are often confronted with issues concerning patent law and intellectual property law. Nevertheless, they generally find a way to avoid infringing existing patents, such as process patents. They have various options in that respect, such as seeking a declaration of non-infringement or ‘clearing the way’ by informing the originator undertaking of their intention to enter the market. They may also launch their products ‘at risk’, defending themselves against any allegations of infringement or bringing a counter-claim calling into question the validity of the patents relied on in support of an infringement action. Lastly, they may also work with their API supplier in order to alter the production process or reduce the risk of infringement, or they may switch to another API producer in order to avoid such risk. |
| 95 | Komisija je v točkah od 621 do 623 obrazložitve izpodbijanega sklepa spomnila, da so v obravnavani zadevi izvirni patenti družbe Lundbeck v večini držav EGP potekli januarja 2002. Zaradi tega je nastal dinamičen konkurenčni proces, v katerem je več podjetij, ki proizvajajo ali prodajajo generična zdravila, ukrepalo s ciljem biti prvo, ki bo vstopilo na trg. Družba Lundbeck se je te nevarnosti zavedala od decembra 1999, ko je v svoj strateški načrt za leto 2000 zapisala svoje pričakovanje „da bodo generiki do leta 2002 prevzeli znaten delež prodaje Cipramila“. Podobno je družba Lundbeck decembra 2001 v svoj strateški načrt za leto 2002 zapisala svoje pričakovanje, da bo trg Združenega kraljestva resno prizadela konkurenca generikov. Komisija je na podlagi teh dejavnikov ugotovila, da so generična podjetja v času sklenitve spornih sporazumov vršila konkurenčni pritisk na družbo Lundbeck. | 95 | In recitals 621 to 623 of the contested decision, the Commission noted that, in the present case, Lundbeck’s original patents had expired by January 2002 in most EEA countries. That had generated a dynamic competitive process, in which several undertakings producing or selling generic medicinal products had taken steps in order to be the first to enter the market. Lundbeck had been aware of that threat since December 1999, when it wrote in a strategic plan for 2000 that ‘by 2002 ... generics [were] expected to have captured a substantial share of Cipramil sales’. Likewise, in December 2001, Lundbeck wrote in its strategic plan for 2002 that it expected that the United Kingdom market in particular would be severely hit by generic competition. In the light of those factors, the Commission took the view that the generic undertakings were exerting competitive pressure on Lundbeck at the time the agreements at issue were concluded. |
| 96 | Poleg tega je Komisija v točkah od 624 do 633 obrazložitve izpodbijanega sklepa ugotovila, da je izpodbijanje patentov izraz potencialne konkurence v farmacevtskem sektorju. V zvezi s tem je opozorila, da podjetjem, ki želijo prodajati generična zdravila v EGP, pri pridobitvi DZP ali za začetek trženja svojih proizvodov ni treba dokazati, da ti ne kršijo nobenega patenta. Proizvajalec originalnih zdravil mora dokazati, da ti proizvodi vsaj na prvi pogled kršijo enega njegovih patentov, da lahko sodišče zadevnemu podjetju prepove nadaljnjo prodajo njegovih proizvodov na trgu. V obravnavani zadevi je Komisija zlasti na podlagi presoje strank spornih sporazumov menila, da je obstajala do 60‑odstotna možnost, da bi sodišče razveljavijo patent za kristalizacijo, na katerega se je družba Lundbeck močno oprla zaradi preprečitve vstopa generikov v Združenem kraljestvu, in da ga generična podjetja niso dojemala kot nov. V takih okoliščinah je Komisija menila, da je to, da generična podjetja vstopajo na trg „s tveganjem“ in da so lahko soočena s tožbami družbe Lundbeck zaradi kršitev, izraz potencialne konkurence. Zato je Komisija ugotovila, da patentirani postopki družbe Lundbeck niso omogočali preprečitve vsakršne možnosti za vstop generičnih podjetij na trg. | 96 | In addition, in recitals 624 to 633 of the contested decision, the Commission stated that challenging patents is an expression of potential competition in the pharmaceutical sector. It noted, in that respect, that in the EEA, undertakings that wish to sell generic medicinal products are not required to demonstrate that their products do not infringe any patents in order to obtain an MA or to begin marketing those products. It is for the originator undertaking to prove, at least in a prima facie fashion, that those products infringe one of its patents, in order to obtain a court injunction prohibiting any further sales of those products on the market. In the present case, the Commission considered, relying inter alia on the assessments of the parties to the agreements at issue, that the crystallisation patent, on which Lundbeck heavily relied in order to block the market entry of generics in the United Kingdom, had a 60% chance of being held invalid by a court and that it was not perceived as novel by the generic undertakings. In those circumstances, the Commission considered that the possibility for generic undertakings to enter the market ‘at risk’ and potentially face infringement actions brought by Lundbeck was an expression of potential competition. Accordingly, the Commission concluded that Lundbeck’s process patents were not capable of blocking all possibilities of market entry open to the generic undertakings. |
| 97 | Komisija je v točki 635 obrazložitve izpodbijanega sklepa opredelila osem možnih načinov vstopa na zadevni trg, in sicer: | — | prvič, dajanje proizvoda na trg „s tveganjem“ z izpostavljanjem morebitnim tožbam družbe Lundbeck zaradi kršitev; | — | drugič, prizadevanje za „sprostitev poti“ s proizvajalcem originalnih zdravil pred vstopom na trg, zlasti v Združenem kraljestvu; | — | tretjič, predlog za ugotovitev neobstoja kršitve pri nacionalnem sodišču pred vstopom na trg; | — | četrtič, uveljavljanje neveljavnosti patenta pri nacionalnem sodišču v nasprotni tožbi zoper tožbo proizvajalca originalnega zdravila zaradi kršitev patenta; | — | petič, izpodbijanje patenta pri pristojnih nacionalnih organih ali pri EPU s predlogom za razveljavitev ali zožitev patenta; | — | šestič, sodelovanje s trenutnim proizvajalcem AFU ali njegovim dobaviteljem – v primeru podjetja Merck (GUK) družbo Schweizerhall Pharma International GmbH (v nadaljevanju: družba Schweizerhall) – pri spremembi proizvodnega postopka AFU tako, da se odpravi ali zmanjša tveganje kršitve patentiranih postopkov proizvajalca originalnih zdravil; | — | sedmič, uporaba drugega proizvajalca AFU v okviru obstoječe dobaviteljske pogodbe; | — | osmič, uporaba drugega proizvajalca AFU zunaj obstoječe dobaviteljske pogodbe, bodisi ker to navedena pogodba dovoljuje bodisi ker bi bila izključna dobaviteljska pogodba lahko razveljavljena, če bi bilo ugotovljeno, da so bili z dobavljeno AFU kršeni patentirani postopki družbe Lundbeck. | 97 | In recital 635 of the contested decision, the Commission identified eight possible routes to the market in the present case, namely: | — | first, launching the product ‘at risk’ and facing possible infringement actions brought by Lundbeck; | — | secondly, making efforts to ‘clear the way’ with the originator undertaking before entering the market, especially in the United Kingdom; | — | thirdly, requesting a declaration of non-infringement from a national court before entering the market; | — | fourthly, claiming patent invalidity before the national courts, as a counter-claim to a claim of patent infringement made by the originator undertaking; | — | fifthly, opposing a patent before the competent national authorities or the EPO and requesting that the patent be revoked or narrowed; | — | sixthly, working with the current API producer or its supplier — in the case of Merck (GUK), Schweizerhall Pharma International GmbH (‘Schweizerhall’) — to change the API producers’ process in such a way as to eliminate or reduce the risk of infringement of the originator undertaking’s process patents; | — | seventhly, switching to another API producer within the existing supply contract; | — | eighthly, switching to another API producer outside of the existing supply contract, either because the existing supply contract permits it or possibly because an exclusive supply contract could be invalidated if the supplied API were found to infringe Lundbeck’s process patents. |
| B – Uporabljiva načela in sodna praksa | B – Applicable principles and case-law |
| 1. Pojem potencialna konkurenca | 1. The concept of potential competition |
| 98 | Najprej je treba ugotoviti, da se člen 101(1) PDEU glede na pogoje iz te določbe v zvezi z vplivom na trgovino med državami članicami in posledicami za konkurenco uporablja samo v sektorjih, odprtih za konkurenco (glej sodbo z dne 29. junija 2012, E.ON Ruhrgas in E.ON/Komisija, T‑360/09, ZOdl., EU:T:2012:332, točka 84 in navedena sodna praksa). | 98 | It must be noted, first of all, that, having regard to the requirements set out in Article 101(1) TFEU regarding effect on trade between Member States and repercussions on competition, that provision applies only to sectors open to competition (see judgment of 29 June 2012 in E.ON Ruhrgas and E.ON v Commission, T‑360/09, ECR, EU:T:2012:332, paragraph 84 and the case-law cited). |
| 99 | V skladu s sodno prakso preizkus konkurenčnih razmer na določenem trgu ne temelji samo na obstoječi konkurenci med podjetji, ki so že na zadevnem trgu, ampak tudi na potencialni konkurenci, da bi se ob upoštevanju strukture trga ter gospodarskega in pravnega okvira njegovega delovanja ugotovilo, ali obstajajo dejanske in konkretne možnosti za konkurenco med zadevnimi podjetji ali za vstop novega konkurenta na zadevni trg in njegovo konkuriranje tam že prisotnim podjetjem (sodbe z dne 15. septembra 1998, European Night Services in drugi/Komisija, T‑374/94, T‑375/94, T‑384/94 in T‑388/94, ZOdl., EU:T:1998:198, točka 137, z dne 14. aprila 2011, Visa Europe in Visa International Service/Komisija, T‑461/07, ZOdl., EU:T:2011:181, točka 68, ter zgoraj v točki 98 navedena sodba E.ON Ruhrgas in E.ON/Komisija, EU:T:2012:332, točka 85). | 99 | According to the case-law, the examination of conditions of competition on a given market must be based not only on existing competition between undertakings already present on the relevant market but also on potential competition, in order to ascertain whether, in the light of the structure of the market and the economic and legal context within which it functions, there are real concrete possibilities for the undertakings concerned to compete among themselves or for a new competitor to enter the relevant market and compete with established undertakings (judgments of 15 September 1998 in European Night Services and Others v Commission, T‑374/94, T‑375/94, T‑384/94 and T‑388/94, ECR, EU:T:1998:198, paragraph 137; 14 April 2011 in Visa Europe and Visa International Service v Commission, T‑461/07, ECR, EU:T:2011:181, paragraph 68, and E.ON Ruhrgas and E.ON v Commission, cited in paragraph 98 above, EU:T:2012:332, paragraph 85). |
| 100 | Komisija mora pri preizkusu, ali je neko podjetje potencialen konkurent na trgu, preveriti, ali bi, če se obravnavani sporazum ne bi sklenil, obstajale dejanske in konkretne možnosti, da to podjetje vstopi na navedeni trg in konkurira na trgu že prisotnim podjetjem. Tak dokaz ne sme temeljiti samo na hipotezi, ampak mora biti podprt z dejstvi ali analizo strukture upoštevnega trga. Tako podjetja ni mogoče opredeliti kot potencialnega konkurenta, če njegov vstop na trg ni ekonomsko uspešna strategija (glej zgoraj v točki 98 navedeno sodbo E.ON Ruhrgas in E.ON/Komisija, EU:T:2012:332, točka 86 in navedena sodna praksa). | 100 | In order to determine whether an undertaking is a potential competitor in a market, the Commission is required to determine whether, if the agreement in question had not been concluded, there would have been real concrete possibilities for it to enter that market and to compete with established undertakings. Such a demonstration must not be based on a mere hypothesis, but must be supported by factual evidence or an analysis of the structures of the relevant market. Accordingly, an undertaking cannot be described as a potential competitor if its entry into a market is not an economically viable strategy (see judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 98 above, EU:T:2012:332, paragraph 86 and the case-law cited). |
| 101 | Iz tega nujno izhaja, da je namen podjetja, da vstopi na trg, morda upošteven pri proučitvi, ali je podjetje mogoče šteti za potencialnega konkurenta na navedenem trgu, vendar je bistveni element, na katerem mora temeljiti ta opredelitev, njegova sposobnost, da vstopi na navedeni trg (glej zgoraj v točki 98 navedeno sodbo E.ON Ruhrgas in E.ON/Komisija, EU:T:2012:332, točka 87 in navedena sodna praksa). | 101 | It necessarily follows that, while the intention of an undertaking to enter a market may be of relevance in order to determine whether it can be considered to be a potential competitor in that market, nonetheless the essential factor on which such a description must be based is whether it has the ability to enter that market (see judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 98 above, EU:T:2012:332, paragraph 87 and the case-law cited). |
| 102 | V zvezi s tem je treba spomniti, da odgovor na vprašanje, ali je potencialna konkurenca – ki je lahko že zgolj obstoj podjetja zunaj tega trga – omejena, ne more biti odvisen od zmožnosti dokazovanja, da to podjetje namerava v bližnji prihodnosti vstopiti na navedeni trg. To podjetje lahko namreč že z obstojem izvaja konkurenčni pritisk na trenutno delujoča podjetja na tem trgu, pri čemer je ta pritisk verjetnost vstopa novega konkurenta, če trg postane privlačnejši (zgoraj v točki 99 navedena sodba Visa Europe in Visa International Service/Komisija, EU:T:2011:181, točka 169). | 102 | It should, in that regard, be recalled that whether potential competition — which may be no more than the existence of an undertaking outside that market — is restricted cannot depend on whether it can be demonstrated that that undertaking intends to enter that market in the near future. The mere fact of its existence may give rise to competitive pressure on the undertakings currently operating in that market, a pressure represented by the likelihood that a new competitor will enter the market if the market becomes more attractive (judgment in Visa Europe and Visa International Service v Commission, cited in paragraph 99 above, EU:T:2011:181, paragraph 169). |
| 103 | Poleg tega je bilo v sodni praksi pojasnjeno, da to, da že prisotno podjetje na trgu želi skleniti sporazume ali izvajati mehanizme izmenjave informacij z drugimi podjetji, ki na tem trgu niso prisotna, resno kaže na to, da na ta trg ni nemogoče vstopiti (glej v tem smislu sodbi z dne 12. julija 2011, Hitachi in drugi/Komisija, T‑112/07, ZOdl., EU:T:2011:342, točka 226, in z dne 21. maja 2014, Toshiba/Komisija, T‑519/09, EU:T:2014:263, točka 231). | 103 | Moreover, it also follows from the case-law that the very fact that an undertaking already present on the market seeks to conclude agreements or to establish information exchange mechanisms with other undertakings which are not present on the market provides a strong indication that the market in question is not impenetrable (see, to that effect, judgments of 12 July 2011 in Hitachi and Others v Commission, T‑112/07, ECR, EU:T:2011:342, paragraph 226, and 21 May 2014 in Toshiba v Commission, T‑519/09, EU:T:2014:263, paragraph 231). |
| 104 | Čeprav iz navedene sodne prakse izhaja, da se Komisija lahko med drugim opre na dojemanje na trgu prisotnega podjetja pri presoji, ali so druga podjetja njegovi potencialni konkurenti, pa povsem teoretična možnost vstopa na trg ne zadostuje za dokazovanje obstoja potencialne konkurence. Komisija mora torej z dejstvi ali analizo strukture upoštevnega trga dokazati, da bi se vstop na trg lahko zgodil dovolj hitro, da bi nevarnost potencialnega vstopa lahko vplivala na ravnanje udeležencev na trgu, na podlagi ekonomsko sprejemljivih stroškov (glej v tem smislu zgoraj v točki 98 navedeno sodbo E.ON Ruhrgas in E.ON/Komisija, EU:T:2012:332, točki 106 in 114). | 104 | Although it follows from that case-law that the Commission may rely inter alia on the perception of the undertaking present on the market in order to assess whether other undertakings are potential competitors, nevertheless, the purely theoretical possibility of market entry is not sufficient to establish the existence of potential competition. The Commission must therefore demonstrate, by factual evidence or an analysis of the structures of the relevant market, that the market entry could have taken place sufficiently quickly for the threat of a potential entry to influence the conduct of the participants in the market, on the basis of costs which would have been economically viable (see, to that effect, judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 98 above, EU:T:2012:332, paragraphs 106 and 114). |
| 2. Dokazno breme | 2. The burden of proof |
| 105 | Iz sodne prakse in člena 2 Uredbe št. 1/2003 izhaja, da mora stranka ali organ, ki zatrjuje kršitev pravil o konkurenci, to tudi dokazati. Tako mora Komisija v primeru spora o obstoju kršitve dokazati kršitve, ki jih zatrjuje, ter predložiti dokaze, ki pravno zadostno dokazujejo obstoj dejstev, ki pomenijo kršitev (glej sodbo z dne 12. aprila 2013, CISAC/Komisija, T‑442/08, ZOdl., EU:T:2013:188, točka 91 in navedena sodna praksa). | 105 | It follows from settled case-law, and from Article 2 of Regulation No 1/2003, that it is for the party or the authority alleging an infringement of the competition rules to prove its existence. Thus, where there is a dispute as to the existence of an infringement, it is incumbent on the Commission to prove the infringements which it has found and to adduce evidence capable of demonstrating to the requisite legal standard the existence of circumstances constituting an infringement (see judgment of 12 April 2013 in CISAC v Commission, T‑442/08, ECR, EU:T:2013:188, paragraph 91 and the case-law cited). |
| 106 | V tem okviru je treba dvom sodišča razlagati v korist podjetja, naslovnika odločbe o ugotovitvi kršitve. Sodišče torej ne more sklepati, da je Komisija pravno zadostno dokazala obstoj zadevne kršitve, če še vedno dvomi o tem vprašanju, zlasti v okviru tožbe za razglasitev ničnosti sklepa o naložitvi globe (glej zgoraj v točki 105 navedeno sodbo z dne CISAC/Komisija, EU:T:2013:188, točka 92 in navedena sodna praksa). | 106 | In that context, any doubt on the part of the Court must operate to the advantage of the undertaking to which the decision finding an infringement was addressed. The Court cannot therefore conclude that the Commission has established the infringement in question to the requisite legal standard if it still entertains any doubts on that point, in particular in proceedings for annulment of a decision imposing a fine (see judgment in CISAC v Commission, cited in paragraph 105 above, EU:T:2013:188, paragraph 92 and the case-law cited). |
| 107 | Upoštevati je namreč treba domnevo nedolžnosti, kot izhaja zlasti iz člena 48 Listine Evropske unije o temeljnih pravicah. Z vidika narave zadevnih kršitev ter narave in stopnje strogosti sankcij, ki so zanje predpisane, se domneva nedolžnosti uporablja zlasti v postopkih – ki se nanašajo na kršitev pravil o konkurenci, ki veljajo za podjetja – v katerih se lahko naložijo globe ali periodične denarne kazni (glej v tem smislu zgoraj v točki 105 navedeno sodbo CISAC/Komisija, EU:T:2013:188, točka 93 in navedena sodna praksa). | 107 | It is necessary to take into account the principle of the presumption of innocence resulting in particular from Article 48 of the Charter of Fundamental Rights of the European Union. Given the nature of the infringements in question and the nature and degree of severity of the penalties which may ensue, the presumption of innocence applies, inter alia, to the procedures relating to infringements of the competition rules applicable to undertakings that may result in the imposition of fines or periodic penalty payments (see, to that effect, judgment in CISAC v Commission, cited in paragraph 105 above, EU:T:2013:188, paragraph 93 and the case-law cited). |
| 108 | Poleg tega je treba upoštevati nezanemarljiv poseg v ugled, ki ga za fizično ali pravno osebo pomeni ugotovitev, da je bila vpletena v kršitev pravil o konkurenci (glej zgoraj v točki 105 navedeno sodbo CISAC/Komisija, EU:T:2013:188, točka 95 in navedena sodna praksa). | 108 | In addition, account must be taken of the non-negligible stigma attached to a finding of involvement in an infringement of the competition rules for a natural or legal person (see judgment in CISAC v Commission, cited in paragraph 105 above, EU:T:2013:188, paragraph 95 and the case-law cited). |
| 109 | Zato se mora Komisija sklicevati na natančne in dosledne dokaze, da bi dokazala obstoj kršitve in da bi utemeljila trdno prepričanje, da gre pri zatrjevanih kršitvah za omejevanje konkurence v smislu člena 101(1) PDEU (glej zgoraj v točki 105 navedeno sodbo CISAC/Komisija, EU:T:2013:188, točka 96 in navedena sodna praksa). | 109 | Thus, the Commission must show precise and consistent evidence in order to establish the existence of the infringement and to support the firm conviction that the alleged infringement constitutes a restriction of competition within the meaning of Article 101(1) TFEU (see judgment in CISAC v Commission, cited in paragraph 105 above, EU:T:2013:188, paragraph 96 and the case-law cited). |
| 110 | Vendar je treba spomniti, da ni nujno, da vsak dokaz, ki ga predloži Komisija, izpolnjuje ta merila glede vsakega elementa kršitve. Dovolj je, da sklenjen krog indicev, na katerega se sklicuje institucija – če se presoja celostno – izpolnjuje to zahtevo (glej zgoraj v točki 105 navedeno sodbo CISAC/Komisija, EU:T:2013:188, točka 97 in navedena sodna praksa). | 110 | However, it is important to emphasise that it is not necessary for every item of evidence produced by the Commission to satisfy those criteria in relation to every aspect of the infringement. It is sufficient if the set of indicia relied on by the institution, viewed as a whole, meets that requirement (see judgment in CISAC v Commission, cited in paragraph 105 above, EU:T:2013:188, paragraph 97 and the case-law cited). |
| 111 | Nazadnje, ugotoviti je treba, da če Komisija dokaže udeležbo zadevnega podjetja pri protikonkurenčnem ukrepu, mora to podjetje – ne samo na podlagi nerazkritih dokumentov, ampak tudi z vsemi drugimi razpoložljivimi sredstvi – drugače pojasniti svoje ravnanje (glej v tem smislu sodbo z dne 7. januarja 2004, Aalborg Portland in drugi/Komisija, C‑204/00 P, C‑205/00 P, C‑211/00 P, C‑213/00 P, C‑217/00 P in C‑219/00 P, ZOdl., EU:C:2004:6, točki 79 in 132). | 111 | Lastly, it must be pointed out that, when the Commission establishes that the undertaking in question has participated in an anticompetitive measure, it is for that undertaking to provide, using not only documents that were not disclosed but also all the means at its disposal, a different explanation for its conduct (see, to that effect, judgment of 7 January 2004 in Aalborg Portland and Others v Commission, C‑204/00 P, C‑205/00 P, C‑211/00 P, C‑213/00 P, C‑217/00 P and C‑219/00 P, ECR, EU:C:2004:6, paragraphs 79 and 132). |
| 112 | Če pa ima Komisija listinske dokaze o protikonkurenčnem ravnanju, ne zadostuje, da zadevna podjetja navedejo okoliščine, ki dejstva, ki jih je ugotovila Komisija, prikazujejo drugače in tako omogočajo, da se njena razlaga dejstev nadomesti z drugo. Če obstajajo listinski dokazi, morajo navedena podjetja ne le podati drugačno razlago dejstev, ki jih je ugotovila Komisija, temveč tudi zanikati obstoj teh dejstev, podprtih z dokazili, ki jih je predložila Komisija (glej v tem smislu zgoraj v točki 105 navedeno sodbo CISAC/Komisija, EU:T:2013:188, točki 99 in 102 ter navedena sodna praksa). | 112 | Nevertheless, where the Commission has documentary evidence of an anticompetitive practice, it is not sufficient for the undertakings concerned to prove circumstances which cast the facts established by the Commission in a different light and thus allow another explanation of the facts to be substituted for the one adopted by the Commission. In the presence of documentary evidence, the burden is on those undertakings not merely to submit another explanation for the facts found by the Commission but to challenge the existence of those facts established on the basis of the documents produced by the Commission (see, to that effect, judgment in CISAC v Commission, cited in paragraph 105 above, EU:T:2013:188, paragraphs 99 and 102 and the case-law cited). |
| 3. Obseg nadzora Splošnega sodišča | 3. The extent of the Court’s review |
| 113 | Spomniti je treba, da lahko sodišče Unije na podlagi člena 263 PDEU opravlja nadzor tako nad dejstvi kot nad uporabo prava v zvezi s trditvami, ki jih tožeče stranke navedejo zoper izpodbijano odločitev, ter da ima pooblastilo za presojo dokazov in razglasitev ničnosti izpodbijane odločitve. Čeprav ima torej Komisija diskrecijo na področjih, ki zahtevajo kompleksno ekonomsko presojo, to ne pomeni, da se mora sodišče Unije vzdržati nadzora nad razlago podatkov ekonomske narave, ki jo opravi Komisija. Sodišče Unije mora namreč med drugim preveriti ne le vsebinsko pravilnost navedenih dokazov, njihovo verodostojnost in skladnost, ampak tudi, ali ti dokazi vsebujejo vse upoštevne podatke, ki jih je treba upoštevati pri presoji zapletenega položaja, in ali lahko utemeljijo iz njih izpeljane ugotovitve (glej v tem smislu sodbo z dne 10. julija 2014, Telefónica in Telefónica de España/Komisija, C‑295/12 P, ZOdl., EU:C:2014:2062, točki 53 in 54 ter navedena sodna praksa). | 113 | It must be borne in mind that Article 263 TFEU involves review by the EU judicature, in respect of both the law and the facts, of the arguments relied on by applicants against the contested decision, which means that it has the power to assess the evidence and annul that decision. Accordingly, whilst, in areas giving rise to complex economic assessments, the Commission has a margin of discretion, that does not mean that the Court must refrain from reviewing the Commission’s interpretation of information of an economic nature. The Court must not only establish whether the evidence put forward is factually accurate, reliable and consistent but must also determine whether that evidence contains all the relevant data that must be taken into consideration in appraising a complex situation and whether it is capable of substantiating the conclusions drawn from it (see, to that effect, judgment of 10 July 2014 in Telefónica and Telefónica de España v Commission, C‑295/12 P, ECR, EU:C:2014:2062, paragraphs 53 and 54 and the case-law cited). |
| 114 | Na tej podlagi je treba presoditi trditve tožečih strank v zvezi z odsotnostjo potencialne konkurence med njima in generičnimi podjetji ob sklenitvi spornih sporazumov. | 114 | The applicants’ arguments concerning the absence of potential competition between them and the generic undertakings at the time the agreements were concluded must be examined in the light of those considerations. |
| C – Prvi del: dajanje zdravil na trg, s katerimi so bile kršene pravice intelektualne lastnine tretjih oseb, ni izraz potencialne konkurence v smislu člena 101 PDEU | C – The first part, alleging that the launch of medicinal products that infringe third parties ’ intellectual property rights is not the expression of potential competition under Article 101 TFEU |
| 115 | Tožeči stranki trdita, da je bilo v izpodbijanem sklepu napačno uporabljeno pravo s presojo, da je dajanje zdravil na trg, s katerimi so bile kršene pravice intelektualne lastnine tretjih oseb, izraz potencialne konkurence v smislu člena 101 PDEU. Utemeljevanje obstoja potencialne konkurence na hipotezi dajanja generičnih zdravil na trg s tveganjem tožbe zaradi kršitev na podlagi patentov teh tretjih oseb naj ne bi bilo združljivo z varstvom patentov in izključnih pravic, ki iz njih izhajajo. S členom 101 PDEU naj bi bila varovana samo zakonita konkurenca, ta pa ne more obstajati, kadar izključna pravica, kot je patent, pravno ali dejansko preprečuje vstop na trg. | 115 | The applicants submit that the contested decision is vitiated by an error in law in that it takes the view that the launch of medicinal products that infringe third parties’ intellectual property rights is the expression of potential competition under Article 101 TFEU. Basing the existence of potential competition on the hypothesis of the launch of generic medicinal products on the market, with the risk of facing infringement proceedings on the basis of those third parties’ patents, is incompatible with the protection conferred on patents and the exclusive rights to which they give rise. Article 101 TFEU protects only lawful competition, which cannot exist where an exclusive right, like a patent, precludes market entry, in law or in fact. |
| 116 | Komisija te trditve zavrača. | 116 | The Commission disputes those arguments. |
| 117 | Spomniti je treba, da je poseben cilj intelektualne lastnine med drugim zagotoviti imetniku patenta – kot nadomestilo za ustvarjalni napor izumitelja – izključno pravico do uporabe izuma pri proizvodnji in prvemu dajanju industrijskih proizvodov v promet, bodisi neposredno bodisi s podelitvijo licenc tretjim osebam, in tudi pravico do izpodbijanja kakršne koli kršitve (sodba z dne 31. oktobra 1974, Centrafarm in de Peijper, 15/74, ZOdl., EU:C:1974:114, točka 9). | 117 | The Court notes that the specific purpose of industrial property is, inter alia, to ensure that the patentee, in order to reward the creative effort of the inventor, has the exclusive right to use an invention with a view to manufacturing industrial products and putting them into circulation for the first time, either directly or by the grant of licences to third parties, as well as the right to oppose infringements (judgment of 31 October 1974 in Centrafarm and de Peijper, 15/74, ECR, EU:C:1974:114, paragraph 9). |
| 118 | Vendar sodna praksa nikakor ne izključuje uporabe člena 101(1) PDEU za sporazume o poravnavah v zvezi s patenti. Nasprotno, določa, da navedeni člen ne vpliva na obstoj pravic na področju intelektualne lastnine, določenih v zakonodaji države članice, vendar pa se lahko za pogoje za njihovo izvajanje uporabljajo prepovedi, ki jih določa. Tako je lahko vsakokrat, kadar se zdi, da je obstoj take pravice predmet, sredstvo ali posledica omejevalnega sporazuma (glej v tem smislu zgoraj v točki 17 navedeno sodbo Centrafarm in de Peijper, EU:C:1974:114, točki 39 in 40). | 118 | However, the case-law in no way excludes the application of Article 101(1) TFEU to settlement agreements that may be concluded in relation to patents. On the contrary, if follows from the case-law that, although the existence of rights recognised under the industrial property legislation of a Member State is not affected by Article 101(1) TFEU, the conditions under which those rights may be exercised may nevertheless fall within the prohibitions contained in that article. This may be the case whenever the exercise of such a right appears to be the object, the means or the consequence of an agreement, decision or concerted practice (see, to that effect, judgment in Centrafarm and de Peijper, cited in paragraph 117 above, EU:C:1974:114, paragraphs 39 and 40). |
| 119 | Podobno se Komisija v skladu s sodno prakso – čeprav opredelitev obsega patenta ni njena naloga – ne more vzdržati kakršnega koli ukrepanja, kadar je patent upošteven za ugotavljanje obstoja kršitve členov 101 in 102 PDEU (sodba z dne 25. februarja 1986, Windsurfing International/Komisija, 193/83, ZOdl., EU:C:1986:75, v nadaljevanju: sodba Windsurfing, točka 26). Sodišče je pojasnilo tudi, da posebnega predmeta patenta ni mogoče razlagati tako, da zagotavlja zaščito tudi zoper tožbe za izpodbijanje veljavnosti patenta, ker je v javnem interesu, da se odpravijo kakršne koli ovire za gospodarsko dejavnost, ki lahko izhajajo iz nepravilno podeljenega patenta (zgoraj navedena sodba Windsurfing, EU:C:1986:75, točka 92). | 119 | Likewise, according to the case-law, although the Commission is not competent to determine the scope of a patent, it may not refrain from all action when the scope of the patent is relevant for the purposes of determining whether there has been an infringement of Articles 101 TFEU and 102 TFEU (judgment of 25 February 1986 in Windsurfing International v Commission, 193/83, ECR, ‘the Windsurfing judgment’, EU:C:1986:75, paragraph 26). The Court of Justice has also held that the specific subject matter of the patent cannot be interpreted as also affording protection against actions brought in order to challenge the patent’s validity, in view of the fact that it is in the public interest to eliminate any obstacle to economic activity which may arise where a patent was granted in error (the Windsurfing judgment, EU:C:1986:75, paragraph 92). |
| 120 | V obravnavani zadevi pa trditve tožečih strank temeljijo na napačni premisi, da so na eni strani generična podjetja nedvomno kršila njune patente, in na drugi, da bi ti patenti gotovo prestali ugovore neveljavnosti, ki bi jih generična podjetja uveljavljala v morebitnih postopkih zaradi kršitev. | 120 | In the present case, the applicants’ argument is based on the erroneous premiss that, first, the generic undertakings undoubtedly infringed the applicants’ patents and, secondly, those patents would certainly have withstood the claims of invalidity that would have been raised by the generic undertakings in infringement actions. |
| 121 | Čeprav je namreč res, da se veljavnost patentov domneva, dokler jih za to pristojni organ ali sodišče izrecno ne prekliče ali razveljavi, pa ta domneva veljavnosti ni enaka domnevi nezakonitosti generičnih proizvodov, ki so veljavno na trgu in za katere imetnik patenta meni, da se z njimi krši patent. | 121 | Whilst patents are indeed presumed valid until they are expressly revoked or invalidated by a competent authority or court, that presumption of validity cannot be equated with a presumption of illegality of generic products validly placed on the market which the patent holder deems to be infringing the patent. |
| 122 | Kot utemeljeno navaja Komisija, ne da bi tožeči stranki to izpodbijali, morata ti stranki v obravnavani zadevi pred nacionalnimi sodišči dokazati, da bi generiki, ki bi vstopili na trg, kršili kateri koli od njunih patentiranih postopkov, saj vstop s tveganjem ni nezakonit. Poleg tega bi lahko generična podjetja v primeru tožbe zaradi kršitev, ki bi jo zoper njih vložila družba Lundbeck, z nasprotno tožbo izpodbijala veljavnost patenta, na katerega bi se sklicevala družba Lundbeck. Take tožbe so namreč v patentih sporih pogoste in velikokrat vodijo v ugotovitev neveljavnosti patentiranega postopka, na katerega se sklicuje imetnik (glej točki 75 in 76 obrazložitve izpodbijanega sklepa). Tako iz dokazov v točkah 157 in 745 obrazložitve izpodbijanega sklepa izhaja, da je družba Lundbeck v zvezi s patentom za kristalizacijo to verjetnost sama ocenila na od 50 do 60 %. | 122 | As the Commission rightly points out, without this being called into question by the applicants, in the present case it was for the applicants to prove before the national courts, in the event that generics entered the market, that those generics infringed one of their process patents, since an ‘at risk’ entry is not unlawful in itself. Moreover, in the context of an infringement action brought by Lundbeck against the generic undertakings, those undertakings could have contested the validity of the patent on which Lundbeck relied by raising a counter-claim. Such claims occur frequently in patent litigation and lead, in numerous cases, to a declaration of invalidity of the process patent relied on by the patent holder (see recitals 75 and 76 of the contested decision). Thus, it can be seen from the evidence set out in recitals 157 and 745 of the contested decision that Lundbeck itself estimated the probability that its crystallisation patent would be held invalid at 50 to 60%. |
| 123 | Poleg tega iz izpodbijanega sklepa jasno izhaja, da se je Komisija pri dokazovanju obstoja potencialne konkurence v obravnavani zadevi oprla na sodno prakso iz zgoraj v točki 99 navedenih sodb European Night Services in drugi/Komisija (EU:T:1998:198) ter Visa Europe in Visa International Service/Komisija (EU:T:2011:181), po kateri je treba preveriti, ali ob upoštevanju strukture trga in gospodarskega ter pravnega okvira njegovega delovanja obstajajo dejanske in konkretne možnosti za konkurenco med zadevnimi podjetji ali za vstop novega konkurenta na zadevni trg in njegovo konkuriranje tam že prisotnim podjetjem (točki 610 in 611 obrazložitve izpodbijanega sklepa). | 123 | In addition, it is clear from the contested decision that, in order to establish the existence of potential competition in the present case, the Commission relied on the case-law established in the judgments in European Night Services and Others v Commission, cited in paragraph 99 above (EU:T:1998:198), and Visa Europe and Visa International Service v Commission, cited in paragraph 99 above (EU:T:2011:181), according to which it must be examined whether, given the structure of the market and the economic and legal context within which it functions, there are real concrete possibilities for the undertakings concerned to compete among themselves or for a new competitor to enter the relevant market and compete with established undertakings (recitals 610 and 611 of the contested decision). |
| 124 | V zvezi s tem je treba na podlagi elementov, na katere je bilo opozorjeno zgoraj v točki 122, ugotoviti, da Komisija ni storila napake pri presoji, da patentirani postopki družbe Lundbeck ne pomenijo nujno nepremostljivih ovir za generična podjetja (glej v tem smislu zgoraj v točki 103 navedeno sodbo Toshiba/Komisija, EU:T:2014:263, točka 230), ki želijo in so pripravljena vstopiti na trg citaloprama ter so v času sklenitve spornih sporazumov že izvedla znatne naložbe v ta namen. | 124 | In that respect, in view of the factors recalled in paragraph 122 above, it must be found that the Commission did not commit an error in considering that Lundbeck’s process patents did not necessarily constitute insurmountable barriers for the generic undertakings (see, to that effect, judgment in Toshiba v Commission, cited in paragraph 103 above, EU:T:2014:263, paragraph 230), which were willing and ready to enter the citalopram market, and which had already made considerable investments to that end at the time the agreements at issue were concluded. |
| 125 | Resda je mogoče, da bi lahko v določenih primerih tožeči stranki uspeli pri pristojnih sodiščih zoper generična podjetja doseči začasne odredbe ali odškodnine. Vendar iz dokazov v izpodbijanem sklepu za vsako generično podjetje izhaja, da takrat te možnosti niso dojemala kot dovolj verjetno grožnjo zanje. Podjetje Merck (GUK) je tako na primer po objavi patenta za kristalizacijo družbe Lundbeck menilo, da citalopram družbe Natco „ni sporen“, da „nobena objavljena prijava patenta […] ne predstavlja težave“, in da ob upoštevanju izjav strokovnjakov ni bilo „nikakršne težave na področju patentov“ (točke 237, 248 in 334 obrazložitve izpodbijanega sklepa). | 125 | It is indeed possible that, in certain cases, the applicants might have been successful before the competent courts and obtained injunctions or damages against the generic undertakings. However, it can be seen from the evidence in the contested decision as regards each of the generic undertakings that that possibility was not perceived at the time as a sufficiently credible threat to them. Thus Merck (GUK) had taken the view, for example, following the publication of the crystallisation patent, that the Natco citalopram was ‘non-infringing’, that ‘none of the published patent applications ... constitute a problem’ and that, in the light of expert statements, it did ‘not have a patent problem at all’ (recitals 237, 248 and 334 of the contested decision). |
| 126 | Poleg tega nikakor ni bilo gotovo, da bi tožeči stranki dejansko vložili tožbe ob vstopu generikov na trg. Resda je v izpodbijanem sklepu potrjeno, da sta po njuni splošni strategiji grozili s tožbami zaradi kršitev ali da bosta take tožbe vložili na podlagi njunih patentiranih postopkov. Vendar je bila kakršna koli odločitev o pravnih sredstvih odvisna od presoje tožečih strank, kako verjetno bi bila tožba uspešna in ali bi bilo za generični proizvod na trgu ugotovljeno, da gre za kršitev. Sta se pa zavedali, da „bi lahko generični proizvajalci citalopram proizvajali po postopku, opisanem v [njunem] izvirnem patentu, s katerim je bila zaščitena AFU […], ali pa bi vložili v iznajdbo povsem novega postopka“ (točka 150 obrazložitve izpodbijanega sklepa). Poleg tega se je družba Lundbeck v zvezi z možnimi nasprotnimi tožbami zavedala, da patent za kristalizacijo ni bil „najbolj trden patent“, in da so nekateri njeni konkurenti menili, da gre za „srednješolsko kemijo“ (točka 149 obrazložitve izpodbijanega sklepa). | 126 | In addition, it was not at all certain that the applicants would have actually initiated litigation in the event that generics entered the market. The contested decision indeed acknowledges that the applicants had put in place a general strategy consisting in threatening infringement actions or bringing such actions on the basis of their process patents. Nevertheless, any decision to bring an action depended on the applicants’ assessment of the probability that an action would be successful and that a marketed generic product would be held to be infringing. Yet they were aware that ‘generic [manufacturers] could have produced citalopram by using the process described in [the applicants’] original compound patent ... or they could have invested to invent an entirely new process’ (recital 150 of the contested decision). Furthermore, faced with possible counter-claims, Lundbeck knew that the crystallisation patent was ‘not the strongest of all patents’ and that it was considered by some of its rivals to be ‘high school chemistry’ (recital 149 of the contested decision). |
| 127 | Nazadnje, ugotoviti je treba, da so izvirni patenti družbe Lundbeck v času sklenitve spornih sporazumov že potekli, in da patent za kristalizacijo v Združenem kraljestvu v smislu člena 25 UK Patent Act 1977 ob sklenitvi sporazumov GUK za Združeno kraljestvo in Arrow UK še ni bil dokončno odobren. Sprejetje začasnih ukrepov v korist družbe Lundbeck v Združenem kraljestvu zoper podjetji Merck (GUK) in Arrow je bilo torej, če že ne nemogoče, pa vsaj zelo malo verjetno, če bi ti dve podjetji vstopili na trg Združenega kraljestva pred datumom izdaje tega patenta. Zato je malo verjetno, da bi lahko družba Lundbeck dosegla začasne odredbe zoper vsa generična podjetja, tudi če bi sistematično vlagala tožbe zoper njih. Podobno je bil patent za jod podeljen šele 26. marca 2003. | 127 | Lastly, it must be observed that, in the present case, Lundbeck’s original patents had already expired when the agreements at issue were concluded, and that the crystallisation patent had not yet been definitively granted in the United Kingdom, for the purpose of Article 25 of the UK Patents Act 1977, when the GUK United Kingdom agreement and the Arrow UK agreement were concluded. The grant of interim measures in favour of Lundbeck in the United Kingdom against Merck (GUK) and Arrow would therefore have been, if not impossible, at the very least unlikely in the event that those undertakings entered the United Kingdom market before that patent was granted. Consequently, it is unlikely that Lundbeck could have obtained injunctions against all of the generic undertakings, even if it had systematically brought actions against them. Likewise, the iodo patent was not granted until 26 March 2003. |
| 128 | Zato je treba ugotoviti – tako kot Komisija v točki 635 obrazložitve izpodbijanega sklepa – da so imela generična podjetja v času sklenitve spornih sporazumov nasploh več konkretnih in dejanskih možnosti za vstop na trg (točka 97 zgoraj). Med temi je zlasti dajanje na trg generičnega proizvoda „s tveganjem“, z možnostjo soočenja z družbo Lundbeck v okviru morebitnih sporov. | 128 | It must therefore be found, as the Commission did in recital 635 of the contested decision, that in general the generic undertakings had several routes — constituting real concrete possibilities — to enter the market at the time the agreements at issue were concluded (paragraph 97 above). Those possible routes included, inter alia, launching the generic product ‘at risk’, with the possibility of having to face proceedings brought by Lundbeck. |
| 129 | Taka možnost je dejansko izraz potencialne konkurence v položaju, kakršen je tisti v obravnavani zadevi, v katerem so izvirni patenti družbe Lundbeck za citalopram ter za postopka alkilacije in cianacije potekli, in v katerem so obstajali drugi postopki, po katerih je mogoče proizvesti generični citalopram, za katere ni bilo dokazano, da se z njimi kršijo drugi patenti družbe Lundbeck, kar sta tožeči stranki sami priznali v odgovoru na obvestilo o ugotovitvah o možnih kršitvah. Poleg tega ukrepi in naložbe generičnih podjetij zaradi vstopa na trg citaloprama pred sklenitvijo spornih sporazumov, ki jih Komisija za vsako generično podjetje opisuje v izpodbijanem sklepu (glej točke od 738 do 743 in od 827 do 832 obrazložitve za podjetje Merck (GUK), točke od 877 do 883 in od 965 do 969 obrazložitve za podjetje Arrow, točke od 1016 do 1018 obrazložitve za podjetje Alpharma ter točke od 1090 do 1102 obrazložitve za podjetje Ranbaxy) in katerih obstoja tožeči stranki nista zanikali, kažejo na to, da so bila ta pripravljena za vstop na trg in prevzem tveganja, ki ga tak vstop pomeni. | 129 | That possibility represents the expression of potential competition, in a situation such as that in the present case where Lundbeck’s original patents, concerning both the citalopram API and the cyanation and alkylation processes, had expired and where there were other processes allowing the production of generic citalopram that had not been found to infringe other Lundbeck patents, which the applicants themselves acknowledged in their reply to the statement of objections. In addition, the steps taken and investments made by the generic undertakings in order to enter the citalopram market before concluding the agreements at issue, as set out by the Commission in the contested decision as regards each of the generic undertakings (see recitals 738 to 743 and 827 to 832 as regards Merck (GUK), recitals 877 to 883 and 965 to 969 as regards Arrow, recitals 1016 to 1018 as regards Alpharma and recitals 1090 to 1102 as regards Ranbaxy) — the existence of which has not been contested by the applicants — show that they were ready to enter the market and to accept the risks involved in such an entry. |
| 130 | Nazadnje, zavrniti je treba tudi trditev tožečih strank, da vstop generičnih podjetij s tveganjem ne bi bil zakonit, zaradi česar ne more biti obravnavan kot zakonito izvajanje dejanske ali potencialne konkurence. | 130 | Lastly, the applicants’ argument that an ‘at risk’ entry of the generic undertakings would have been unlawful, with the result that it cannot be regarded as the lawful exercise of actual or potential competition, must also be rejected. |
| 131 | Sodna praksa namreč zahteva samo dokaz, da so imela generična podjetja dejanske in konkretne možnosti ter sposobnost vstopiti na trg, kar gotovo drži, ker so izvedla znatne naložbe zaradi vstopa na trg, ker so že pridobila DZP ali ukrenila vse potrebno za njihovo pridobitev v ustreznem roku. V zvezi s tem je treba spomniti, da so nekatera celo uspela na lastno tveganje priti na trg pred sklenitvijo spornih sporazumov ali po njej. Tako je družba NM Pharma, distributer podjetja Merck (GUK) na Švedskem, dosegla „spodbudno“ prodajo v skoraj petih mesecih na švedskem trgu pred sklenitvijo sporazuma za EGP, ne da bi jo družba Lundbeck ovirala (točka 837 obrazložitve izpodbijanega sklepa). Tudi podjetje Merck (GUK) je uspelo v Združenem kraljestvu avgusta 2003 prodati tablete citaloprama v vrednosti 3,3 milijona GBP, preden je doseglo drugo, donosnejše podaljšanje sporazuma GUK za Združeno kraljestvo. Sprejetje teze tožečih strank bi pomenilo strinjanje s tem, da celo tak dejanski vstop na trg ni izraz potencialne konkurence, samo zato ker sta bili prepričani o njegovi nezakonitosti in ker bi ga lahko potencialno izpodbijali z zahtevanjem začasnih odredb ali odškodnine s sklicevanjem na njune patentirane postopke. Iz razlogov, navedenih v točkah od 120 do 122 zgoraj, pa je treba take utemeljitve zavrniti. | 131 | The case-law requires only that it be demonstrated that the generic undertakings had real concrete possibilities and the capacity to enter the market, which is certainly the case when those undertakings had made significant investments in order to enter the market and when they had already obtained MAs or had taken the necessary steps to obtain them within a reasonable period. In that respect, it must be borne in mind that some of them even entered the market, at their own risk, before or after the conclusion of the agreements at issue. Thus, NM Pharma, Merck (GUK)’s distributor in Sweden, had made ‘encouraging’ sales for almost five months on the Swedish market, before the conclusion of the EEA agreement, without being worried by Lundbeck (recital 837 of the contested decision). Merck (GUK) had also been able to sell generic citalopram tablets for a value of GBP 3.3 million in the United Kingdom in August 2003, before obtaining a second, more lucrative, extension of the GUK United Kingdom agreement. To accept the applicants’ argument would amount to accepting that such an effective entry to the market does not constitute the expression of potential competition, simply because the applicants were convinced of the unlawful nature of that entry and they could potentially have tried to prevent it by relying on their process patents in infringement actions. For the reasons set out in paragraphs 120 to 122 above, that line of argument must be rejected. |
| 132 | Zato tožeči stranka napačno menita, da je Komisija kršila domnevo veljavnosti njunih patentov in pravic intelektualne lastnine v zvezi z njimi s tem, da je vstop generičnih podjetij na trg „s tveganjem“ v obravnavani zadevi opredelila kot izraz potencialne konkurence med družbo Lundbeck in temi podjetji v obravnavani zadevi. | 132 | Accordingly, the applicants are not correct in their submission that the Commission disregarded the presumption of validity of their patents and the related intellectual property rights by characterising the ‘at risk’ entry of generic undertakings to the market as the expression of potential competition between Lundbeck and those undertakings in the present case. |
| 133 | Prvi del je zato treba zavrniti. | 133 | The first part must therefore be rejected. |
| D – Drugi del: Komisija se je pri sklepu, da so bila generična podjetja dejanski ali potencialni konkurenti družbe Lundbeck, oprla na subjektivno presojo | D – The second part, alleging that the Commission relied on subjective assessments in concluding that the generic undertakings were actual or potential competitors of Lundbeck |
| 134 | Tožeči stranki menita, da se izpodbijani sklep pri dokazovanju, ali so stranke spornih sporazumov potencialni konkurenti, napačno opira na subjektivno presojo teh strank v zvezi z veljavnostjo patenta in tem, ali se ga z nekim proizvodom krši ali ne. | 134 | The applicants maintain that the contested decision errs in relying on the subjective assessment of the parties to the agreements at issue as to whether a patent is valid and whether a product is infringing or non-infringing in order to determine whether those parties were potential competitors. |
| 135 | Prvič, menita da v izpodbijanem sklepu ni zadostno dokazana subjektivna presoja generičnih podjetij, da je obstajala dejanska možnost razsodbe sodišča, da so patenti družbe Lundbeck nični in/ali da niso bili kršeni. V skladu s členom 2 Uredbe št. 1/2003 pa je morala Komisija dokazati, da je bil v obdobjih, ki jih zajemajo sporni sporazumi, vstop brez kršitev možen. Taka presoja naj bi temeljila tudi na nezadostnih in spreminjajočih se informacijah, zato ne morejo biti uporabljene kot dokaz obstoja potencialne konkurence med strankami spornih sporazumov. | 135 | In the first place, they maintain that the contested decision does not prove to the requisite standard that the generic undertakings’ subjective assessment was that they considered that there was a realistic prospect that a court would find that Lundbeck’s patents were invalid and/or that they were not infringed. Under Article 2 of Regulation No 1/2003, it is for the Commission to prove that a non-infringing market entry was possible during the periods covered by the agreements at issue. Such an assessment is based, moreover, on insufficient information which did not remain constant and could not therefore be used to demonstrate the existence of potential competition between the parties to the agreements at issue. |
| 136 | Drugič, izpodbijani sklep naj bi bil napačen in naj ne bi upošteval objektivnih dejavnikov, ki potrjujejo težave generičnih podjetij pri vstopanju na trg, kot na primer znanstveni dokazi, ki jih je predložila družba Lundbeck in ki dokazujejo obstoj kršitve, potrditev veljavnosti patenta za kristalizacijo v vseh upoštevnih vidikih tako od pritožbenega senata EPU kot nizozemskega patentnega urada, ali pa to, da je družba Lundbeck dosegla začasne odredbe ali druge oblike začasnih ukrepov v več kot 50 % postopkov, ki jih je sprožila v letih 2002–2003. V izpodbijanem sklepu naj torej ne bi bila zadostno dokazana sposobnost generičnih podjetij, da vstopijo na trg, prav tako naj v njem ne bi bilo odgovorjeno na vprašanje, ali so bili patenti družbe Lundbeck veljavni in kršeni v času sklenitve spornih sporazumov, kar naj bi bilo objektivno vprašanje. | 136 | In the second place, they argue that the contested decision is flawed and fails to take account of the objective elements which confirm the difficulty which the generic undertakings encountered in entering the market, such as the scientific evidence supplied by Lundbeck proving the existence of a patent infringement, the confirmation, by both the EPO Appeal Board and the Netherlands Patent Office, of the validity of the crystallisation patent on all relevant aspects, or the fact that Lundbeck had been granted preliminary injunctions or other forms of interim relief in more than 50% of the proceedings which it had initiated in 2002-2003. The contested decision therefore fails to establish to the requisite standard the ability of the generic undertakings to enter the market and does not resolve the question whether Lundbeck’s patents were valid and had been infringed at the time of the conclusion of the agreements at issue, which is an objective question. |
| 137 | Komisija te trditve zavrača. | 137 | The Commission disputes those arguments. |
| 138 | Uvodoma je treba potrditi pristop Komisije, kot izhaja iz celotnega izpodbijanega sklepa, da se upoštevajo predvsem dokazi pred sklenitvijo spornih sporazumov ali ob njej (glej v tem smislu sodbo z dne 11. julija 2014, Esso in drugi/Komisija, T‑540/08, ZOdl., EU:T:2014:630, točka 75 in navedena sodna praksa). | 138 | As a preliminary point, the Court confirms the Commission’s approach, as it can be seen from the contested decision as a whole, which consisted in principally taking into account evidence prior to or contemporaneous with the date on which the agreements at issue were concluded (see, by analogy, judgment of 11 July 2014, Esso and Others v Commission, T‑540/08, ECR, EU:T:2014:630, paragraph 75 and the case-law cited). |
| 139 | Komisija namreč na eni strani ne more rekonstruirati preteklosti z domišljanjem dogodkov, ki bi se lahko zgodili, pa se niso prav zaradi teh sporazumov. Na drugi strani pa so stranke teh sporazumov zdaj vsekakor zainteresirane utemeljevati, da niso imele nobene dejanske možnosti za vstop na trg, ali da so menile, da se z njihovimi proizvodi krši kateri od patentov družbe Lundbeck. Vendar so se za določen način ravnanja in sklenitev spornih sporazumov odločile izključno na podlagi njihovih takratnih informacij in njihovega takratnega dojemanja trga. | 139 | First, the Commission cannot reconstruct the past by imagining the events that would have occurred and which did not in fact occur as a result of those agreements. Secondly, the parties to those agreements now have every interest in arguing that they had no realistic perspective of entering the market or that they thought that their products infringed one of Lundbeck’s patents. Nevertheless, it is solely on the basis of the information available to them at the time and their perception of the market at that time that they decided to adopt a particular course of conduct and concluded the agreements at issue. |
| 140 | Sicer pa je tak pristop v skladu z usmeritvami zgoraj v točki 119 navedene sodbe Windsurfing (EU:C:1986:75, točka 26), v kateri je Sodišče menilo, da Komisija ni pristojna za opredelitev obsega patenta, ne more pa opustiti kakršnega koli ukrepanja, če je obseg patenta upošteven za ugotavljanje kršitve členov 101 in 102 PDEU. | 140 | Moreover, that approach is consistent with the Windsurfing judgment, cited in paragraph 119 above (EU:C:1986:75, paragraph 26), where the Court of Justice held that the Commission was not competent to determine the scope of a patent, but that it could not refrain from all action when the scope of a patent was relevant for the purpose of determining whether there had been an infringement of Articles 101 TFEU and 102 TFEU. |
| 141 | Komisija torej ni storila napake s tem, da se je oprla na objektivne dokumente, ki odražajo, kako so stranke spornih sporazumov ob njihovi sklenitvi dojemale moč patentiranih postopkov družbe Lundbeck (glej zlasti točko 669 obrazložitve izpodbijanega sklepa) pri presoji konkurenčnega položaja med temi strankami, vendar je mogoče upoštevati tudi poznejše dokaze, če omogočajo razjasnitev njihovega takratnega stališča, potrditev ali izpodbijanje njihovih utemeljitev v zvezi s tem in boljše razumevanje zadevnega trga. Ti poznejši dokazi pa vsekakor ne morejo biti odločilni pri presoji obstoja potencialne konkurence med strankami spornih sporazumov. | 141 | The Commission therefore did not err in relying on objective documents reflecting the perception that the parties to the agreements at issue had of the strength of Lundbeck’s process patents at the time those agreements were concluded (see inter alia recital 669 of the contested decision) in order to evaluate the competitive situation between those parties, it being noted that subsequent evidence may also be taken into account provided that it is capable of clarifying those parties’ positions at the time, confirming or challenging their arguments in that respect as well as allowing a better understanding of the market concerned. In any event, that subsequent evidence cannot be decisive in the examination of the potential competition between the parties to the agreements at issue. |
| 142 | Tožeči stranki poleg tega napačno trdita, da se je Komisija pri ugotavljanju obstoja potencialne konkurence med generičnimi podjetji v izpodbijanem sklepu „skoraj izključno“ oprla na tako subjektivno presojo. Komisija je namreč podrobno analizirala dejanske in konkretne možnosti vsakega zadevnega generičnega podjetja za vstop na trg in se pri tem oprla na objektivne dokaze kot, na primer, že izvedene naložbe, ukrepe za pridobitev DZP in sklenjene dobaviteljske pogodbe med drugim z njihovimi dobavitelji AFU. Tožeči stranki sta sicer te različne dokaze izrecno izpodbijali za vsako generično podjetje in bodo obravnavani od šestega do devetega dela spodaj. | 142 | In addition, the applicants wrongly submit that the Commission relied ‘almost exclusively’ on such subjective assessments in order to establish the existence of potential competition between them and the generic undertakings in the contested decision. The Commission in fact carried out a careful examination, as regards each of the generic undertakings concerned, of the real concrete possibilities they had of entering the market, relying on objective evidence such as the investments already made, the steps taken in order to obtain an MA and the supply contracts concluded with, amongst others, their API suppliers. Those various pieces of evidence have also been expressly contested by the applicants, as regards each generic undertaking, and will be examined in the sixth to ninth parts below. |
| 143 | Podobno tožeči stranki ne moreta uspeti s trditvijo, da Komisija ni dovolj upoštevala dokazov, ki sta jih predložili in ki naj bi dokazovali, da so generična podjetja kršila njune patente, ali da je patent za kristalizacijo veljaven, kar naj bi med drugim leta 2009 v celoti potrdil EPU. | 143 | Similarly, the applicants cannot succeed in their argument that the Commission did not take sufficient account of the evidence which they supplied, showing that their patents were infringed by the generic undertakings and that the crystallisation patent was valid, which was confirmed, inter alia, by the EPO on all relevant aspects in 2009. |
| 144 | Na eni strani, čeprav bi bilo mogoče na podlagi drugih izjav v času sklenitve spornih sporazumov sklepati, da so generična podjetja dvomila v to, da s svojimi proizvodi ne kršijo patentov, ali da je bila družba Lundbeck prepričana v veljavnost svojih patentov, pa to ne zadostuje za ovrženje sklepa, da so bila generična podjetja razumljena kot potencialna grožnja za družbo Lundbeck in so lahko že samo s svojim obstojem vršila konkurenčni pritisk nanjo in na že prisotna podjetja na istem trgu (glej v tem smislu zgoraj v točki 99 navedeno sodbo Visa Europe in Visa International Service/Komisija, EU:T:2011:181, točka 169). Največjo dokazno vrednost ima v zvezi s tem dejstvo, da je družba Lundbeck sklenila sporazume z generičnimi podjetji, da bi preložila njihov vstop na trg (glej v tem smislu zgoraj v točki 103 navedeno sodbo Toshiba/Komisija, EU:T:2014:263, točka 231). | 144 | First, although other statements contemporaneous with the conclusion of the agreements at issue might suggest that the generic undertakings had doubts concerning the non-infringing nature of their products, or that Lundbeck was convinced of the validity of its patents, those statements are not enough to call into question the conclusion that the generic undertakings were perceived as a potential threat for Lundbeck and were liable, by their very existence, to exert competitive pressure on Lundbeck and on the undertakings operating in the same market (see, to that effect, judgment in Visa Europe and Visa International Service v Commission, cited in paragraph 99 above, EU:T:2011:181, paragraph 169). The strongest evidence in that respect is the very fact that Lundbeck concluded agreements with generic undertakings in order to delay their entry to the market (see, to that effect, judgment in Toshiba v Commission, cited in paragraph 103 above, EU:T:2014:263, paragraph 231). |
| 145 | Na drugi strani dokazi, na katere se opirata tožeči stranki in so iz časa po sklenitvi spornih sporazumov, ne morejo biti odločilni pri presoji obstoja potencialne konkurence v času sklenitve navedenih sporazumov. Tudi če je EPU leta 2009 v vseh upoštevnih vidikih potrdil patent za kristalizacijo (glej točko 166 obrazložitve izpodbijanega sklepa), so tako generična podjetja kot družba Lundbeck v času sklenitve spornih sporazumov dvomili v veljavnost tega patenta, in ni bilo izključeno, da bi ga lahko nacionalno sodišče razveljavilo, kot se je sicer sprva zgodilo pri EPU (točki 151 in 166 obrazložitve izpodbijanega sklepa). | 145 | Secondly, the evidence invoked by the applicants which dates from after the conclusion of the agreements at issue cannot be decisive in evaluating the existence of potential competition at the time those agreements were concluded. Even if the EPO had confirmed the crystallisation patent on all relevant aspects in 2009 (see recital 166 of the contested decision), it is nevertheless the case that, at the time the agreements at issue were concluded, the generic undertakings as well as Lundbeck itself doubted the validity of that patent and it was possible that a national court might declare it invalid, as had initially occurred at the EPO (recitals 151 and 166 of the contested decision). |
| 146 | Poleg tega – kot utemeljeno navaja Komisija – v času sklenitve spornih sporazumov na predlog družbe Lundbeck ni bil izdal noben začasni ukrep, niti zoper generična podjetja, kot je podjetje Merck (GUK), ki je uporabljalo citalopram družbe Natco, niti zoper generična podjetja kot sta podjetji Arrow in Alpharma, ki sta uporabljali citalopram družbe Cipla ali generični citalopram, razvit iz AFU citalopram, ki ga je po svojih postopkih proizvajala indijska družba Matrix (v nadaljevanju: citalopram družbe Matrix ali AFU družbe Matrix), niti zoper generična podjetja, ki so uporabljala generični citalopram, razvit iz AFU citalopram, ki ga je po svojih postopkih proizvajalo podjetje Ranbaxy (v nadaljevanju: citalopram podjetja Ranbaxy ali AFU podjetja Ranbaxy), niti ni nobeno sodišče EGP ugotovilo kršitve patentov za kristalizacijo, za amid ali za jod. | 146 | Furthermore, as the Commission rightly submits, at the time the agreements at issue were concluded, no interim measure had been obtained by Lundbeck, whether against generic undertakings using the Natco citalopram, such as Merck (GUK), against generic undertakings using the Cipla citalopram or the generic citalopram developed from the API produced by the Indian company Matrix (‘the Matrix citalopram’ or ‘the Matrix API’), such as Arrow and Alpharma, or against generic undertakings using the generic citalopram developed from the citalopram API produced by Ranbaxy (‘the Ranbaxy citalopram’ or ‘the Ranbaxy API’), and no court in the EEA had found an infringement of the crystallisation, amide or iodo patents. |
| 147 | Tožeči stranki torej napačno trdita, da se je Komisija pri ugotovitvi, da so bili družba Lundbeck in generična podjetja v času sklenitve spornih sporazumov potencialni konkurenti, v bistvu oprla na subjektivno presojo. | 147 | The applicants are therefore incorrect in their submission that the Commission relied mainly on subjective assessments in order to find that Lundbeck and the generic undertakings were potential competitors at that time the agreements at issue were concluded. |
| 148 | Zato je treba tudi drugi del zavrniti. | 148 | Accordingly, the second part must also be rejected. |
| E – Tretji del: izpodbijanje veljavnega patenta ne pomeni dejanskih in konkretnih možnosti za vstop na trg | E – The third part, alleging that challenging a valid patent does not constitute a real concrete possibility of entering the market |
| 149 | Tožeči stranki trdita, da je Komisija napačno uporabila pravo s presojo, da izpodbijanje veljavnega patenta pomeni dejansko in konkretno možnost za vstop na trg. Še posebej se ne strinjata s tem, da predlaganje ugotovitve neobstoja kršitve, uveljavljanje neveljavnosti patenta ali izpodbijanje patenta pred nacionalnimi organi, pristojnimi za patente, ali pred EPU, lahko pomeni ustrezen način vstopa generičnih podjetij na trg, ne glede na patentirane postopke družbe Lundbeck. | 149 | The applicants submit that the Commission erred in law in taking the view that challenging a valid patent constitutes a real concrete possibility of entering the market. They deny, in particular, that seeking a declaration of non-infringement, or claiming that a patent is invalid, or opposing a patent before the national patent authorities, or before the EPO, could constitute appropriate routes whereby the generic undertakings could enter the market, notwithstanding Lundbeck’s processing patents. |
| 150 | Prvič, menita da so v izpodbijanem sklepu pomešani vstop na trg in naložbe, ki omogočajo tak vstop, in da se z njim preveč razširjajo meje potencialne konkurence. Sodna praksa naj bi zahtevala, da se dokažejo realne in konkretne možnosti za vstop na trg in da se ta vstop izvede dovolj hitro, da lahko grožnja s potencialnim vstopom omejuje ravnanje udeležencev na trgu. Ugotovitev dejanskih in konkretnih možnosti za izvedbo naložb, ki bi – če bi bile uspešne – omogočale vstop na trg, ne izpolnjuje tega pogoja. | 150 | In the first place, they maintain that the contested decision confuses market entry with the investments that allow market entry, and that it unduly stretches the boundaries of potential competition. The case-law requires that real concrete possibilities of entering the market be established and that market entry be sufficiently rapid for the threat of potential entry to constitute a constraint on the conduct of market participants. Establishing that there were real concrete possibilities of making investments that, if successful, could allow market entry fails to satisfy that test. |
| 151 | Drugič, domnevna veljavnost patentov naj bi onemogočala sklepanje, da možnost izpodbijanja veljavnosti tega patenta pomeni dejansko in konkretno možnost za vstop na trg. Pristop Komisije v zvezi s tem naj bi bil v nasprotju z zgoraj v točki 99 navedeno sodbo European Night Services in drugi/Komisija (EU:T:1998:198, točka 139). | 151 | In the second place, the presumption of validity enjoyed by patents means that the possibility of challenging the validity of that patent cannot be regarded as constituting a real concrete possibility of entering the market. The approach taken by the Commission in that regard contradicts the judgment of 15 September 1998 in European Night Services and Others v Commission, cited in paragraph 99 above (EU:T:1998:198, paragraph 139). |
| 152 | Tretjič, tudi če bi izpodbijanje patentov lahko pomenilo dejansko in konkretno možnost vstopa na trg, to izpodbijanje ne bi omogočalo dovolj hitrega vstopa. Po navedbah Komisije iz njene preiskave v farmacevtskem sektorju naj bi izpodbijanje patenta trajalo skoraj tri leta, kar naj generičnim podjetjem ne bi omogočalo dovolj hitrega vstopa. Izpodbijani sklep naj v zvezi s tem ne bi bil jasen, če generična podjetja ne bi mogla zakonito vstopiti na trg v času trajanja spornih sporazumov, pa zadnjenavedeni nikakor ne bi mogli vplivati na konkurenco. | 152 | In the third place, even if patent challenges could have constituted a real concrete possibility of entering the market, those challenges would not have made it possible to enter the market sufficiently quickly. As the Commission stated in its pharmaceutical sector inquiry, challenging a patent takes on average almost three years and would therefore not have enabled the generic undertakings to enter the market sufficient quickly. The contested decision is vague on that point, whereas, if the generic undertakings could not have lawfully entered the market during the term of the agreements at issue, the agreements could not have had any impact on competition. |
| 153 | Četrtič, tožeči stranki menita, da bi bilo treba v izpodbijanem sklepu dokazati, tudi če bi bilo stališče Komisije pravilno, da bi generična podjetja brez spornih sporazumov sodno ukrepala in verjetno uspela pri nacionalnih sodiščih ali vsaj, da bi imela možnost za uspeh pri izpodbijanju patentov. | 153 | In the fourth place, the applicants maintain that, even if the Commission’s view is accepted, the contested decision should at least have demonstrated that, in the absence of the agreements at issue, the generic undertakings would have initiated legal actions and would probably have been successful before the national courts or at least that they had prospects of being successful if they challenged the patents. |
| 154 | Nazadnje, tožeči stranki trdita, da teza Komisije temelji na neutemeljeni pristranskosti zoper patentirane postopke v primerjavi s patentiranimi učinkovinami. | 154 | Lastly, the applicants submit that the Commission’s position is based on an unjustified bias against process patents as opposed to compound patents. |
| 155 | Tudi intervenient trdi, da se v izpodbijanem sklepu napačno sklepa, da so bili družba Lundbeck in generična podjetja potencialni konkurenti. Tak sklep naj ne bi dovolj upošteval domneve veljavnosti patentov družbe Lundbeck in dejstva, da bi začasne odredbe pomenile nepremostljivo oviro za generična podjetja pri njihovem poskusu vstopa na trg. Nasprotuje tudi stališču, da je izpodbijanje veljavnosti patentov sestavni del konkurenčnega procesa. | 155 | The intervener also argues that, in the contested decision, the Commission errs in taking the view that Lundbeck and the generic undertakings were potential competitors. Such a finding fails to take sufficient account of the presumption that Lundbeck’s patents were valid or of the fact that interim injunctions would have represented an insurmountable barrier for the generic undertakings if they had attempted to enter the market. The intervener also rejects the argument that challenging the validity of patents is an inherent part of the competitive process. |
| 156 | Komisija te trditve zavrača. | 156 | The Commission disputes those arguments. |
| 157 | V nasprotju s trditvami tožečih strank je treba ugotoviti, da Komisija v izpodbijanem sklepu ni menila, da zgolj možnost izpodbijanja veljavnosti patenta pri sodišču ali pristojnih organih zadostuje kot dokaz obstoja potencialne konkurence. Komisija je namreč pri dokazovanju obstoja potencialne konkurence med generičnimi podjetji in družbo Lundbeck v obravnavani zadevi upoštevala več dejavnikov, kot na primer precejšnje naložbe in že izvedena prizadevanja generičnih podjetij pri pripravi njihovega vstopa na trg, to, da so že pridobila DZP ali ukrenila vse potrebno za njihovo pridobitev v ustreznem roku, da sta tožeči stranki priznali, da je obstajalo nekaj postopkov za proizvodnjo citaloprama, s katerimi se ne kršijo njuni patenti, da nobeno sodišče ni ugotovilo, da se z generičnimi proizvodi v času sklenitve spornih sporazumov kršijo patenti, in da je obstajalo nezanemarljivo tveganje, da bi bili nekateri patentirani postopki družbe Lundbeck lahko razveljavljeni. Poleg tega je eno od generičnih podjetij, namreč podjetje Merck (GUK), pred ali med trajanjem spornih sporazumov celo uspelo vstopiti na trg. Nazadnje, to, da sta se tožeči stranki odločili plačati precejšnje zneske generičnim podjetjem, da bi jih med trajanjem spornih sporazumov zadržali zunaj trga, prav tako dokazuje, da so bila zadnjenavedena potencialni konkurenti, ker sta jih dojemali kot grožnjo, ki vrši konkurenčni pritisk na njun položaj na trgu (točki 103 in 144 zgoraj). | 157 | It must be noted that, contrary to the applicants’ arguments, the Commission did not take the view, in the contested decision, that the mere possibility of challenging the validity of a patent before a court or before the competent authorities suffices to establish the existence of potential competition. In order to establish the existence of potential competition between the generic undertakings and Lundbeck in the present case, the Commission took several factors into consideration, such as the significant investments and efforts already made by the generic undertakings in order to prepare their entry to the market, the fact that they had already obtained MAs or had taken the necessary steps to obtain one within a reasonable period, the fact that the applicants had acknowledged that there were a certain number of processes available to produce citalopram without infringing their patents, the fact that, at the time the agreements at issue were concluded, no court had found the generic products to be infringing and the fact that there was a non-negligible possibility that some of Lundbeck’s process patents might be declared invalid. In addition, a generic undertaking, namely Merck (GUK), even succeeded in entering the market before and during the term of the agreements at issue. Lastly, the fact that the applicants decided to pay significant amounts to the generic undertakings in order to keep them out of the market during the period of the agreements at issue also shows that those generic undertakings were potential competitors, since they were perceived by the applicants as a threat exerting competitive pressure on their position on the market (paragraphs 103 and 144 above). |
| 158 | Tega sklepanja ne more ovreči nobena trditev tožečih strank. | 158 | None of the arguments put forward by the applicants is capable of undermining that conclusion. |
| 159 | Kar zadeva namreč, prvič, naložbe generičnih podjetij zaradi priprave na njihov vstop na trg, zadostuje ugotovitev, da Komisija ni nikoli menila, da take naložbe same po sebi zadostujejo kot dokaz obstoja potencialne konkurence med njimi in tožečima strankama. Nasprotno, Komisija se je v zvezi s tem oprla na več upoštevnih dejavnikov pri vsakem generičnem podjetju (glej točko 157 zgoraj). Poleg tega za obstoj potencialne konkurence – kot utemeljeno navaja Komisija – ni treba dokazati, da bi generična podjetja gotovo vstopila na trg in da bi bil tak vstop neizogibno uspešen, ampak samo to, da so imela dejanske in konkretne možnosti za to. V nasprotnem primeru bi se izničila vsakršna razlika med dejansko in potencialno konkurenco. | 159 | As regards, first, the investments made by the generic undertakings in order to prepare their entry to the market, it suffices to note that the Commission never considered that such investments sufficed by themselves to demonstrate the existence of potential competition between those undertakings and the applicants. The Commission, on the contrary, relied on a set of relevant factors, relating to each generic undertaking, in that respect (see paragraph 157 above). Moreover, as the Commission rightly submitted, in order to establish the existence of potential competition, it is not necessary to demonstrate with certainty that the generic undertakings would have entered the market and that that entry would inevitably have been successful, but only that they had real concrete possibilities in that respect. To assert the contrary would amount to denying any distinction between actual and potential competition. |
| 160 | Resda je v sodni praksi pojasnjeno, da povsem teoretična možnost vstopa na trg ne zadostuje za dokazovanje obstoja potencialne konkurence in da mora Komisija z dejstvi ali analizo strukture upoštevnega trga dokazati, da bi se vstop na trg lahko zgodil dovolj hitro, da bi nevarnost potencialnega vstopa lahko vplivala na ravnanje udeležencev na trgu, na podlagi ekonomsko sprejemljivih stroškov (točka 104 zgoraj). | 160 | The case-law indeed indicates that the purely theoretical possibility of market entry is not sufficient to establish the existence of potential competition and that the Commission must demonstrate, by factual evidence or an analysis of the structures of the relevant market, that the market entry could have taken place sufficiently quickly for the threat of a potential entry to influence the conduct of the participants in the market, on the basis of costs which would have been economically viable (paragraph 104 above). |
| 161 | Vendar ne kaže, da bi Komisija v obravnavani zadevi ravnala v nasprotju z navedeno sodno prakso, ker analiza farmacevtskega sektorja, ki jo je Komisija opravila v izpodbijanem sklepu, in tudi poseben položaj vsakega od generičnih podjetij v času sklenitve spornih sporazumov (točka 129 zgoraj), zadostno dokazujeta, da vstop zadnjenavedenih na trg citaloprama ni bil zgolj teoretična možnost, ampak da so imela dejanske in konkretne možnosti v zvezi s tem, kot izhaja iz analize od šestega do devetega dela spodaj. Sicer pa bi bilo presenetljivo, če bi izkušeno podjetje kot je družba Lundbeck, privolilo v izplačilo več milijonov eurov generičnim podjetjem v zameno za njihovo zavezo, da določen čas ne bodo vstopila na trg, če bi bila njihova možnost za vstop na trg povsem teoretična. | 161 | It does not appear, however, that the Commission disregarded that case-law in the present case, since the analysis of the pharmaceutical sector carried out by the Commission in the contested decision, as well as the particular situation of each generic undertaking at the time the agreements at issue were concluded (paragraph 129 above), adequately demonstrate that the entry of those generic undertakings to the citalopram market was not a mere theoretical possibility, but that they had real concrete possibilities in that respect, as can be seen from the examination of the sixth and ninth parts of the first plea in law below. Moreover, it would be surprising if an undertaking as experienced as Lundbeck would have decided to pay several million euros to the generic undertakings in exchange for their commitment not to enter the market during a certain period if the possibility that those generic undertakings could enter the market was purely theoretical. |
| 162 | Drugič, zgoraj v točki 99 navedena sodba European Night Services in drugi/Komisija (EU:T:1998:198, točka 139), na katero se sklicujeta tožeči stranki, ne nasprotuje pristopu Komisije v obravnavani zadevi. Čeprav je namreč Splošno sodišče v navedeni sodbi omenilo obstoj izključnih pravic, ki so v večini držav članic pred sprejetjem Direktive Sveta z dne 29. julija 1991 o razvoju železnic Skupnosti (UL, posebna izdaja v slovenščini, poglavje 7, zvezek 1, str. 341) dejansko ali pravno preprečevale opravljanje storitev mednarodnega prevoza potnikov in dostop do infrastrukture, pa tak položaj ni prenosljiv v obravnavano zadevo, ker patentirani postopki družbe Lundbeck nikakor niso primerljivi z izključnimi pravicami, ki so jih imela železniška podjetja pred sprejetjem navedene direktive, in ker se zadevni trgi bistveno razlikujejo. Poleg tega je Splošno sodišče – kot utemeljeno ugotavlja Komisija – v zadevi, v kateri je bila izdana navedena sodba, Komisiji očitalo, da pri ugotavljanju obstoja potencialne konkurence ni podrobno analizirala trga in da se je oprla na hipoteze, ki jih ni potrjevalo nobeno dejstvo niti analiza strukture upoštevnega trga. Nasprotno pa tožeči stranki v obravnavani zadevi ne moreta utemeljeno trditi, da so vse upoštevne okoliščine, povzete zgoraj v točki 157 in podrobno opisane v izpodbijanem sklepu za vsako generično podjetje, povsem teoretične domneve, ki niso podprte s podrobno analizo značilnosti upoštevnega trga. | 162 | Secondly, the judgment in European Night Services and Others v Commission, cited in paragraph 99 above (EU:T:1998:198, paragraph 139), relied on by the applicants, does not oppose the approach taken by the Commission in the present case. Although, in that judgment, the Court referred to the existence of exclusive rights precluding, de jure or de facto, in most Member States, both the provision of international passenger services and access to the infrastructure, before the adoption of Council Directive 91/440/EEC of 29 July 1991 on the development of the Community’s railways (OJ 1991 L 237, p. 25), that situation cannot be transposed to the present case, since Lundbeck’s process patents are in no way comparable to the exclusive rights enjoyed by railway undertakings before the adoption of that directive and there are significant differences between the markets concerned. In addition, as the Commission rightly submits, in the case that gave rise to that judgment, the Court had criticised the Commission for failing to carry out a detailed analysis of the market in order to establish the existence of potential competition and for having relied on hypothesises unsupported by any evidence or any analysis of the structures of the relevant market. In the present case, however, the applicants cannot legitimately argue that all of the relevant circumstances, summarised in paragraph 157 above and set out in detail in the contested decision, for each generic undertaking, are purely theoretical speculations unsupported by a detailed analysis of the characteristics of the relevant market. |
| 163 | Tretjič, spomniti je treba, da se s sodno prakso za dokaz obstoja potencialne konkurence zahteva le, da se vstop na trg zgodi v razumnem času, ni pa določila natančnega roka v zvezi s tem. Zato Komisiji ni treba dokazati, da bi generična podjetja gotovo vstopila na trg pred potekom spornih sporazumov, da bi dokazala obstoj potencialne konkurence v obravnavani zadevi, še posebej zato, ker lahko potencialna konkurenca v farmacevtskem sektorju – kot je Sodišče že ugotovilo –obstaja precej pred potekom patenta (glej v tem smislu sodbo z dne 6. decembra 2012, AstraZeneca/Komisija, C‑457/10 P, ZOdl., EU:C:2012:770, točka 108). | 163 | Thirdly, it must be recalled that, in order to establish the existence of potential competition, the case-law requires only that the entry to the market take place within a reasonable period, without fixing a specific limit in that respect. The Commission therefore does not need to demonstrate with certainty that the entry of the generic undertakings to the market would have taken place before the expiry of the agreements at issue in order to be able to establish the existence of potential competition in the present case, particularly since, as the Court of Justice has already held, potential competition may be exerted long before the expiry of a patent (see, to that effect, judgment of 6 December 2012 in AstraZeneca v Commission, C‑457/10 P, ECR, EU:C:2012:770, paragraph 108). |
| 164 | V zvezi s tem je treba ugotoviti, da navedba Sodišča, da potencialna konkurenca lahko obstaja pred potekom patenta, ni odvisna od dejstva, da so bili zadevni DVC pridobljeni na goljufiv ali nezakonit način. V zadevi, v kateri je bila izdana zgoraj v točki 163 navedena sodba AstraZeneca/Komisija (EU:C:2012:770, točka 108), je šlo namreč med drugim za zlorabo prevladujočega položaja, ki jo je storilo podjetje, ki je z zavajajočimi navedbami doseglo, da so mu pristojni nacionalni organi izdali DVC, kar mu je omogočilo, da je tudi po poznejšem poteku patentov, s katerimi je bilo varovano njegovo zdravilo, preprečevalo vstop generičnih različic tega zdravila na trg. V tem okviru je Sodišče v bistvu menilo, da protikonkurenčnost navedenih navedb ni bila ovržena s tem, da so bile prijave za DVC vložene od pet do šest let pred njihovim začetkom veljavnosti in ker so bile do takrat pravice tožečih strank varovane z zakonitimi patenti. Po mnenju Sodišča taki nezakoniti DVC ne povzročajo le velikega izključevalnega učinka po poteku trajanja osnovnih patentov, ampak lahko z vplivanjem na potencialno konkurenco celo pred tem potekom spremenijo tudi strukturo trga. Zato navedena sodna praksa potrjuje, da potencialna konkurenca obstaja že pred potekom patentov, s katerimi je varovano zdravilo, in da je ukrepanje pred tem potekom upoštevno za presojo, ali je bila ta konkurenca omejena. | 164 | In that respect, it should be noted that the remark of the Court of Justice concerning the fact that potential competition may be exerted before the expiry of a patent is independent of the fact that the SPCs at issue in that judgment had been obtained fraudulently or irregularly. The case that gave rise to the judgment in AstraZeneca v Commission, cited in paragraph 163 above (EU:C:2012:770, paragraph 108) concerned, inter alia, an abuse of a dominant position committed by an undertaking which had submitted misleading representations in order to obtain, from the competent national authorities, SPCs allowing it to prevent the entry to the market of generic versions of its medicinal product, even after the future expiry of the patents protecting that product. In that context, the Court of Justice considered, in essence, that the anticompetitive character of those representations was not called into question by the fact that those SPCs had been requested between five and six years before their entry into force and that, until that time, the appellants’ rights had been protected by regular patents. According to the Court of Justice, not only did such unlawful SPCs lead to a significant exclusionary effect after the expiry of the basic patents, but they were also liable to alter the structure of the market by adversely affecting potential competition even before that expiry. Accordingly, that case-law confirms that potential competition already exists before the expiry of patents protecting a medicinal product and that the steps taken before that expiry are relevant in assessing whether that competition was restricted. |
| 165 | Četrtič, tožeči stranki napačno trdita, da bi morala Komisija dokazati, da bi generična podjetja sprožila sodne postopke in uspela pred pristojnimi nacionalnimi sodišči. Iz točke 624 in naslednjih obrazložitve izpodbijanega sklepa namreč izhaja, da generičnim podjetjem ni bilo treba dokazati, da njihovi generični proizvodi ne pomenijo kršitve, zato da bi pridobila DZP in tržila te proizvode na trgu, česar pa tožeči stranki sicer ne izpodbijata. Podjetje Merck (GUK) je tako na Švedskem maja 2002 uspelo vstopiti na trg prek svojega distributerja, družbe NM Pharma, ne da bi bilo treba ugotoviti neobstoj kršitve in ne da bi družba Lundbeck zoper njega sprožila sodne postopke. Proizvajalec originalnih zdravil – torej v tem primeru družba Lundbeck – je tisti, ki mora dokazati, da ti proizvodi kršijo enega od njegovih patentov, kar je po njeni lastni presoji posebej težko dokazati v zvezi s patentiranimi postopki (glej točko 629 obrazložitve izpodbijanega sklepa). Poleg tega – kot navaja Komisija – ni gotovo, da bi družba Lundbeck vsekakor sprožila sodne postopke zoper generična podjetja ob njihovem vstopu na trg (glej točko 126 zgoraj). Še manj je gotovo, da bi družba Lundbeck uspela, če bi se za take postopke odločila (glej točko 122 zgoraj ter točki 75 in 76 obrazložitve izpodbijanega sklepa). | 165 | Fourthly, the applicants wrongly argue that the Commission should have demonstrated that the generic undertakings would have brought legal proceedings and that they would have been successful before the competent national courts. It can be seen from recital 624 et seq. of the contested decision that the generic undertakings were not required to demonstrate that their generic products did not infringe any patent in order to obtain an MA and sell their products in the market, which, moreover, is not called into question by the applicants. Thus, Merck (GUK) was able to enter the market through its distributor NM Pharma in Sweden in May 2002, without having obtained a declaration of non-infringement and without having had legal actions brought against it by Lundbeck. It was for the originator undertaking, namely, in the present case, Lundbeck, to prove that those products infringed one of its patents, which, according to its own estimates, was particularly difficult to establish, as regards process patents (see recital 629 of the contested decision). In addition, as the Commission submits, it is not certain that Lundbeck would have necessarily brought legal proceedings against the generic undertakings if they had entered the market (see paragraph 126 above). It is even less certain that Lundbeck would have been successful, if it had decided to bring such proceedings (see paragraph 122 above and recitals 75 and 76 of the contested decision). |
| 166 | Nazadnje, spomniti je treba, da Komisija ni kršila domneve veljavnosti patentiranih postopkov družbe Lundbeck (točke od 121 do 132 zgoraj). Tožeči stranki zato ne moreta trditi, da izpodbijani sklep temelji na negativni pristranskosti zoper te patente. Komisija je namreč upoštevala obstoj teh patentov, vendar je menila – ne da bi v zvezi s tem storila napako pri presoji – da ti niso omogočali preprečitve vsakršnega vstopa generičnih podjetij na trg v času sklenitve spornih sporazumov. | 166 | Lastly, it must be recalled that the Commission did not disregard the presumption of validity enjoyed by Lundbeck’s process patents (paragraphs 121 to 132 above). The applicants therefore cannot argue that the contested decision is based on a negative bias against such patents. The Commission took account of the existence of those patents but considered, without committing an error of assessment in that respect, that those patents were not capable of blocking any entry of generic undertakings to the market at the time the agreements at issue were concluded. |
| 167 | Tretji del je torej treba zavrniti. | 167 | The third part must therefore be rejected. |
| F – Četrti del: odsotnost DZP preprečuje obstoj dejanske ali potencialne konkurence | F – The fourth part, alleging that the lack of an MA prevents the existence of actual or potential competition |
| 168 | Tožeči stranki trdita, da je Komisija napačno ugotovila obstoj potencialne konkurence – čeprav nekatera generična podjetja niso imela DZP – samo zato, ker so si prizadevala za njihovo pridobitev pred sklenitvijo spornih sporazumov (točka 620 obrazložitve izpodbijanega sklepa). Ta ugotovitev naj bi bila v nasprotju z nekaterimi deli izpodbijanega sklepa (zlasti v točki 85 obrazložitve) ter z ugotovitvami preiskave farmacevtskega sektorja in posameznimi ugotovitvami zadevnih strank glede potrebnega roka za pridobitev DZP, ki naj bi bil najmanj štirinajst mesecev, v nekaterih državah EGP pa lahko traja do petindvajset mesecev. Po njunem mnenju bi bilo treba v izpodbijanem sklepu in concreto presoditi, ali je imelo vsako generično podjetje dejanske in konkretne možnosti za pridobitev DZP v času trajanja spornih sporazumov v različnih zadevnih državah, ker je vsaka država ločen geografski trg in ker so nekateri sporazumi zajemali posamezne države. Vsekakor pa naj DZP ne bi dopuščala takojšnjega vstopa na trg, ker so za to potrebne dodatne pripravljalne faze. | 168 | The applicants submit that the Commission wrongly concluded that there was potential competition despite the fact that some of the generic undertakings did not have an MA, simply because they had tried to obtain one before the agreements at issue were concluded (recital 620 of the contested decision). That finding is inconsistent with certain passages in the contested decision (recital 85 in particular) and also with the findings of the pharmaceutical sector inquiry and the individual observations of the parties concerned on the time taken to obtain an MA, which was at least 14 months and could take as long as 25 months in certain EEA countries. It would have been better, in the applicants’ submission, if the contested decision had assessed in concreto whether each generic undertaking had real concrete possibilities of obtaining an MA during the term of the agreements at issue, and to do so in each of the countries concerned, since each country constituted a separate geographic market and certain agreements related to individual countries. In any event, an MA would not make it possible to enter the market immediately, since additional preparatory stages are necessary in that respect. |
| 169 | Komisija te trditve zavrača. | 169 | The Commission disputes those arguments. |
| 170 | V zvezi s tem je treba najprej v nasprotju z navedbami tožečih strank ugotoviti, da je Komisija za vsako generično podjetje presodila, ali je v času sklenitve spornih sporazumov imelo DZP ali pa bi DZP lahko pridobilo v dovolj bližnji prihodnosti. | 170 | In that respect, it must be noted, first of all, contrary to the applicants’ arguments, that the Commission evaluated, as regards each generic undertaking, whether it had an MA at the time the agreements at issue were concluded or whether it could have obtained an MA in a sufficiently near future. |
| 171 | Poleg tega je treba ugotoviti, da potencialna konkurenca med drugim zajema dejavnosti generičnih podjetij za pridobitev potrebnih DZP ter izvedbo vseh upravnih in poslovnih ukrepov, potrebnih za pripravo vstopa na trg (glej točke od 91 do 94 zgoraj). To potencialno konkurenco varuje člen 101 PDEU. Če bi bilo namreč brez kršenja prava konkurence mogoče plačati podjetjem, ki se pripravljajo za dajanje generičnega zdravila na trg, med katerimi je pridobitev DZP, in ki so s tem namenom izvedla znatne naložbe, za ustavitev ali zgolj upočasnitev tega procesa, dejanske konkurence nikoli ne bi bilo ali pa bi se zgodile znatne zamude na škodo potrošnikov, v obravnavanem primeru torej bolnikov ali zdravstvenih zavarovalnic. | 171 | It must also be observed that potential competition includes inter alia the activities of generic undertakings seeking to obtain the necessary MAs, as well as all the administrative and commercial steps required in order to prepare for entry to the market (see paragraphs 91 to 94 above). That potential competition is protected by Article 101 TFEU. If it were possible, without infringing competition law, to pay undertakings taking the necessary steps to prepare for the launch of a generic medicinal product, including obtaining an MA, and which have made significant investments to that end, to cease or merely slow that process, effective competition would never take place, or would suffer significant delays, at the expense of consumers, that is to say, in the present case, patients or national health insurance schemes. |
| 172 | Tako je Komisija v zvezi s podjetjem Merck (GUK) ugotovila, da je to pridobilo DZP v Združenem kraljestvu 9. januarja 2002, in da je imel tudi njegov distributer, družba NM Pharma, na Švedskem DZP od maja 2002. Podjetje Merck (GUK) in družba NM Pharma sta nameravali izkoristiti 90‑dnevni rok za medsebojno priznavanje iz člena 18 Direktive 2001/83 za pridobitev DZP v drugih državah EGP (točka 326 obrazložitve izpodbijanega sklepa). | 172 | Thus, the Commission found that Merck (GUK) had obtained an MA in the United Kingdom on 9 January 2002, and that its distributor NM Pharma also had an MA in Sweden since May 2002. Merck (GUK) and NM Pharma intended to use the 90-day mutual recognition period laid down in Article 18 of Directive 2001/83 in order to obtain MAs in other countries in the EEA (recital 326 of the contested decision). |
| 173 | Komisija je v zvezi s položajem družbe Arrow v Združenem kraljestvu v točkah od 878 do 881 obrazložitve izpodbijanega sklepa ugotovila, da je ta družba sklenila sporazum z družbo Tiefenbacher, da bi lahko uporabljala DZP, za katerega je družba Tiefenbacher zaprosila v Združenem kraljestvo na podlagi DZP, ki ga je zadnjenavedena že imela na Nizozemskem. Komisija je pojasnila tudi, da se je tik pred podpisom sporazuma Arrow UK pričakovalo, da bodo organi Združenega kraljestva to DZP izdali zelo hitro, in da je poznejša zamuda nastala zato, ker sta tožeči stranki izpodbijali na Nizozemskem izdano DZP. | 173 | As regards Arrow’s position in the United Kingdom, in recitals 878 to 881 of the contested decision, the Commission noted that that undertaking had entered into an agreement with Tiefenbacher, in order to use the MA that Tiefenbacher had requested in the United Kingdom, on the basis of an MA which the latter already possessed in the Netherlands. The Commission also noted that, in the phase immediately preceding the conclusion of the Arrow UK agreement, it was expected that the United Kingdom authorities would issue that MA in the very near future and that the delay which subsequently occurred was due to the applicants’ challenging the MA granted in the Netherlands. |
| 174 | Kar zadeva položaj podjetja Arrow na Danskem, je Komisija v točkah 967 in 968 obrazložitve izpodbijanega sklepa opozorila na to, da je v preambuli danskega sporazuma Arrow navedeno, da bo to podjetje ravnokar pridobilo „dovoljenje“ tretje osebe, kopija DZP te tretje osebe pa je bila priložena sporazumu. Kot utemeljeno izpostavlja Komisija, dejstvo da podjetje Arrow nazadnje ni kupilo tega DZP, ne pomeni, da v času sklenitve navedenega sporazuma ni imelo dejanske in konkretne možnosti za vstop na trg. | 174 | As regards Arrow’s position in Denmark, in recitals 967 and 968 of the contested decision, the Commission emphasised that the preamble to the Danish Arrow agreement mentioned that Arrow was about to obtain a ‘licence’ from a third party and that a copy of the MA granted to that third party was annexed to the agreement. As the Commission rightly submits, the fact that Arrow ultimately did not purchase that MA does not mean that it did not have a real concrete possibility of entering the market at the time that agreement was concluded. |
| 175 | Kar zadeva podjetje Alpharma zlasti iz točk 476, 485, 520 in 530 obrazložitve izpodbijanega sklepa izhaja, da je to podjetje v skladu z dobaviteljsko pogodbo z družbo Tiefenbacher vsaj na Nizozemskem in v Nemčiji lahko uporabljalo DZP, ki so bila izdana zadnjenavedeni, in da je lahko bodisi samo zaprosilo za DZP za druge države članice EGP bodisi zaprosilo družbo Tiefenbacher, da razširi postopek medsebojnega priznavanja na te druge države. | 175 | As regards Alpharma, it can be seen from recitals 476, 485, 520 and 530 of the contested decision that it could use the MAs granted to Tiefenbacher, pursuant to its supply contract with the latter, at least as regards the Netherlands and Germany, and could either itself request an MA for the other EEA Member States or ask Tiefenbacher to extend the mutual recognition procedure to those other countries. |
| 176 | Poleg tega je podjetje Alpharma oktobra leta 2001 načrtovalo pridobitev DZP in dajanje na trg generičnega citaloprama na različne datume leta 2002 v Avstriji, na Danskem, na Finskem, v Nemčiji, na Nizozemskem, na Švedskem in v Združenem kraljestvu. Podobno so bila v času podpisa sporazuma Alpharma izdana štiri DZP (na Danskem, Finskem, Nizozemskem in Švedskem), za DZP za Združeno kraljestvo pa se je pričakovalo, da bo izdano v kratkem (glej točko 281 spodaj). Sicer pa je podjetje Alpharma v času trajanja tega sporazuma pridobilo DZP za druge štiri države EGP (Norveško, Nemčijo, Avstrijo in Združeno kraljestvo). | 176 | In addition, in October 2001 Alpharma intended to obtain MAs and launch generic citalopram, on various dates in 2002, in Austria, Denmark, Finland, Germany, the Netherlands, Norway, Sweden and the United Kingdom. Similarly, when the Alpharma agreement was concluded, four MAs had been granted (in Denmark, Finland, the Netherlands and in Sweden), and the MA for the United Kingdom was expected to be issued in the very near future (see paragraph 281 below). Moreover, during the term of that agreement, Alpharma received MAs for four other countries in the EEA (Norway, Germany, Austria and the United Kingdom). |
| 177 | Kar zadeva podjetje Ranbaxy, je Komisija v točki 1094 obrazložitve izpodbijanega sklepa v bistvu ugotovila, da je to podjetje pri pristojnem organu Združenega kraljestva junija 2002 predložilo osnovno dokumentacijo o zdravilu (Drug Master File, v nadaljevanju: DMF) v zvezi s svojo AFU citalopram. S tem ukrepom – tudi če ni bil nujen za pridobitev DZP – se je olajšal postopek, ki generičnemu podjetju, ki že ima DZP za tablete generičnega citaloprama, proizvedene iz AFU, kot je to pri podjetju Ranbaxy, po katerem se zaprosi za spremembo njegovega DZP tako, da to zajema tudi citalopram podjetja Ranbaxy. Predložitev DMF pristojnim organom omogoča proizvajalcu AFU, da ne razkrije zaupnih podatkov generičnim podjetjem, ki kupujejo njegovo AFU in želijo vložiti prošnjo za DZP za zdravila, ki jih proizvajajo iz te AFU. | 177 | As regards Ranbaxy, in recital 1094 of the contested decision, the Commission noted, in essence, that that undertaking had filed a Drug Master File (‘DMF’) for its citalopram API with the competent United Kingdom authority in June 2002. That step, although not necessary in order to obtain an MA, facilitated the procedure allowing a generic undertaking that already held an MA on generic citalopram tablets produced on the basis of a different API than that of Ranbaxy to request a variation of its MA so that it also included the Ranbaxy citalopram. The filing of a DMF with the competent authorities allows the API manufacturer not to disclose confidential information to the generic undertakings that purchase its API and wish to lodge an MA application in respect of the medicinal products that they produce using that API. |
| 178 | Poleg tega se je Komisija v točki 1095 obrazložitve izpodbijanega sklepa oprla na to, da je podjetje Ranbaxy na sestanku aprila 2002 obvestilo družbo Lundbeck o tem, da bi lahko v osmih mesecih pridobilo DZP in da trenutno potekajo pogovori s potencialnim kupcem njegovega citaloprama, ki bi lahko z njim vstopil na trg v treh ali štirih mesecih, po spremembi DZP, ki ga že ima. Trditev tožečih strank, da so bile take navedbe zgolj „blefiranje“, bo podrobneje obravnavana pri devetem delu tega tožbenega razloga spodaj. | 178 | In addition, in recital 1095 of the contested decision, the Commission relied on the fact that, at a meeting held in April 2002, Ranbaxy had informed Lundbeck that it could obtain an MA within eight months and that it was in discussions with a potential purchaser of its citalopram, a purchaser which could enter the market with that citalopram within three to four months, following a variation of the MA that it already held. The applicants’ argument that such statements were merely ‘bluffing’ will be examined in more detail below, in the ninth part of the present plea in law. |
| 179 | Navedeni dejavniki kažejo na to, da so generična podjetja v času sklenitve spornih sporazumov že pridobila DZP ali so izvedla ustrezne ukrepe za njegovo pridobitev v kratkoročnem ali srednjeročnem obdobju, ali pa so bili njihovi proizvodi zajeti z drugimi DZP. Čeprav je bilo za pridobitev DZP nazadnje potrebno več časa, kot je bilo predvideno, pa še vedno drži, da so imela generična podjetja v času sklenitve spornih sporazumov dejanske in konkretne možnosti za pridobitev teh DZP v dovolj kratkem roku in da so lahko vstopila na trg citaloprama v več državah EGP z uporabo postopka medsebojnega priznavanja iz člena 18 Direktive 2001/83, s čimer so vršila konkurenčni pritisk na družbo Lundbeck. Spomniti je treba tudi, da so generična podjetja v obravnavani zadevi svoje priprave na vstop na trg citaloprama začela od enega do treh let pred potekom izvirnih patentov družbe Lundbeck (glej točke 219, 373, 476 in 549 obrazložitve izpodbijanega sklepa) in da so intenzivno tekmovala za to, da bi prva vstopila na trg ob poteku teh patentov (glej točko 622 obrazložitve izpodbijanega sklepa). | 179 | Those elements show that the generic undertakings concerned had either already obtained an MA at the time the agreements at issue were concluded, were taking the necessary steps to obtain one in the short or medium term, or were able to have their products covered by other MAs. Although, in certain cases, obtaining an MA might ultimately have taken more time than foreseen, it is nevertheless the case that, at the time the agreements at issue were concluded, the generic undertakings had real concrete possibilities of obtaining those MAs within a sufficiently short period and of entering the citalopram market in several EEA countries, by using the mutual recognition procedure laid down in Article 18 of Directive 2001/83, thereby exerting competitive pressure on Lundbeck. In addition, it must be recalled that in the present case, the generic undertakings had begun making preparations to enter the citalopram market one to three years before the expiry of Lundbeck’s original patents (see recitals 219, 373, 476 and 549 of the contested decision), and that they were engaged in an intense race to be the first to enter the market after the expiry of those patents (see recitals 622 of the contested decision). |
| 180 | Komisija torej ni storila napake pri ugotovitvi iz točke 620 obrazložitve izpodbijanega sklepa, da odsotnost DZP ni pomenila, da generična zdravila niso mogla vstopiti na trg v bližnji prihodnosti, medtem ko so si generična podjetja še naprej prizadevala za pridobitev potrebnih dovoljenj v zvezi s tem pred sklenitvijo spornih sporazumov z družbo Lundbeck. | 180 | The Commission therefore did not err in finding, in recital 620 of the contested decision, that the absence of an MA did not mean that the generic medicinal products were not capable of entering the market in the near future, while the generic undertakings continued to take steps to obtain the necessary authorisations in that respect before concluding the agreements at issue with Lundbeck. |
| 181 | Sicer pa je treba spomniti, da se Komisija pri dokazovanju obstoja potencialne konkurence med generičnimi podjetji in družbo Lundbeck, čeprav gre za pomemben dejavnik v zvezi s tem, v izpodbijanem sklepu ni oprla samo na možnost generičnih podjetij, da pridobijo DZP, ampak na niz dejavnikov ob upoštevanju posebnega položaja vsakega generičnega podjetja v času sklenitve spornih sporazumov in posebnosti farmacevtskega sektorja (točke od 91 do 96 in 157 zgoraj). Opozoriti je treba tudi na to, da je dejstvo, da se je družba Lundbeck odločila skleniti sporazume z generičnimi podjetji, pomemben indic, da je ta podjetja v času sklenitve spornih sporazumov dojemala kot potencialno grožnjo (glej v tem smislu zgoraj v točki 103 navedeno sodbo Toshiba/Komisija, EU:T:2014:263, točka 231). | 181 | It must be recalled, moreover, that, even if it is an important factor in that respect, the Commission did not rely solely on the possibility of generic undertakings obtaining an MA in order to establish the existence of potential competition between them and Lundbeck in the contested decision, but rather on a set of factors taking account of the specific situation of each generic undertaking at the time the agreements at issue were concluded as well as the specific characteristics of the pharmaceutical sector (see paragraphs 91 to 96 and 157 above). In addition, it must be recalled that the very fact that Lundbeck decided to conclude agreements with the generic undertakings is a strong indication that it perceived those undertakings as a potential threat at the time the agreements at issue were concluded (see, to that effect, judgment in Toshiba v Commission, cited in paragraph 103 above, EU:T:2014:263, paragraph 231). |
| 182 | Zato je treba tudi četrti del zavrniti. | 182 | The fourth part must therefore also be rejected. |
| G – Peti del: generična podjetja naj med trajanjem spornih sporazumov ne bi mogla uporabljati drugih postopkov in/ali drugih proizvajalcev AFU | G – The fifth part, alleging that the generic undertakings could not have had recourse to other processes and/or other API producers during the term of the agreements at issue |
| 183 | Tožeči stranki izpodbijata ugotovitev v izpodbijanem sklepu, da sta bila med možnimi načini dostopa do trga (točka 635 obrazložitve izpodbijanega sklepa) tudi sodelovanje generičnega podjetja z njegovim proizvajalcem AFU pri spremembi postopka tega proizvajalca ali zamenjava za drugega proizvajalca AFU. Šlo naj bi za teoretične možnosti, ker na eni strani ni obstajala nobena poslovno uspešna metoda za proizvodnjo citaloprama, ki bi omogočala zakonit vstop na trg v EGP letih 2002 in 2003, na drugi pa naj generična podjetja ne bi imela dovolj časa za zamenjavo proizvajalca AFU pred potekom spornih sporazumov. | 183 | The applicants dispute the finding in the contested decision that the possible routes to the market (recital 635 of the contested decision) included, in particular, a generic undertaking working with its API producer to alter that producer’s process or switching to another API producer. They argue that those are theoretical alternative options because, first, there was no other commercially viable method of producing citalopram that would have permitted a lawful entry to the EEA market in 2002 and 2003 and, secondly, the generic undertakings would not have had sufficient time to switch to another API producer before the expiry of the agreements at issue. |
| 184 | Prvič, po mnenju tožečih strank naj ne bi bilo nobenega resnega dokaza za ovrženje dokazov družbe Lundbeck, da ni bilo nobenega poslovno uspešnega in neponarejenega postopka, ki bi omogočal vstop na trg leta 2002 in 2003. Nobeden od dokazov, na katerih temelji izpodbijani sklep v zvezi s podjetji Merck (GUK), Alpharma, Arrow in Ranbaxy, naj ne bi zadostoval za dokaz nasprotnega. | 184 | First, according to the applicants, there is no serious evidence to rebut Lundbeck’s evidence that no commercially viable and non-infringing process would have allowed market entry in 2002 and 2003. None of the evidence put forward in relation to Merck (GUK), Alpharma, Arrow and Ranbaxy is sufficient to prove the contrary. |
| 185 | Sicer pa naj bi se izpodbijani sklep napačno opiral na navedbe družbe Lundbeck pri dokazovanju, da so v času sklenitve spornih sporazumov obstajali drugi neponarejeni postopki (točka 634 obrazložitve izpodbijanega sklepa). Komisija naj bi napačno domnevala, da so bili vsi postopki, ki jih je v eni od svojih izjav naštela družba Lundbeck, neponarejeni, poslovno uspešni in v skladu z zakonodajnimi zahtevami EGP, čeprav naj noben od njih ne bi omogočal vstopa na trg v obdobju 2002‑2003 z zanesljivimi in neponarejenimi zdravili. Po mnenju tožečih strank se v izpodbijanem sklepu zanemarjajo številni dokazi, ki kažejo na to, da izvirni postopki cianacije in alkilacije ne morejo biti uporabljeni za uspešno proizvodnjo citaloprama. | 185 | Furthermore, the contested decision is wrong to rely on Lundbeck’s statements to show that other non-infringing processes were available at the time of the conclusion of the agreements at issue (recital 634 of the contested decision). The Commission wrongly presumed that all the processes listed by Lundbeck in one of its statements were non-infringing, commercially viable and compliant with EEA regulatory requirements, when none of them could have allowed market entry in 2002-2003 with reliable and non-infringing medicinal products. In the applicants’ submission, the contested decision ignores the extensive evidence showing that the original cyanation and alkylation processes could not be used to produce citalopram viably. |
| 186 | Drugič, po mnenju tožečih strank generična podjetja v nobenem primeru, tudi če bi bilo med trajanjem spornih sporazumov mogoče proizvesti generični citalopram po neponarejenem in poslovno uspešnem postopku (kar pa ni bilo), ne bi mogla opraviti zamenjave za ta postopek v mesecih, ki jih zajemajo sporni sporazumi, ali vsaj ne „dovolj hitro“, da bi grožnja s potencialnim vstopom pomenila dejanski konkurenčni pritisk med njihovim trajanjem. | 186 | Secondly, in any event, according to the applicants, even if generic citalopram produced using a non-infringing and commercially viable process had been available during the term of the agreements at issue (which was not the case), the generic undertakings could not have switched to that process during the months covered by the agreements at issue, or at the very least they could not have done so ‘sufficiently quickly’ for the threat of potential entry to represent an effective competitive constraint while those agreements were in force. |
| 187 | Taka zamenjava bi namreč pomenila večjo spremembo tipa II v smislu člena 3 Uredbe Komisije št. 541/95 z dne 10. marca 1995 o pregledu sprememb pogojev [dovoljenja za promet z zdravilom], ki ga je izdal pristojni organ države članice (UL L 55, str. 7, v nadaljevanju: sprememba tipa II), kar je postopek, ki se uporablja za spremembo obstoječega DZP zaradi spremembe proizvajalca AFU. Spremembo tipa II pa je najtežje doseči, ker je treba uporabiti postopek, enakovreden tistemu za vložitev nove vloge za DZP. Ta postopek bi lahko v celoti trajal do 19 mesecev. Poleg tega bi bilo treba k obdobju, potrebnemu za tako spremembo, prišteti še tisto, potrebno za raziskavo in razvoj novega postopka, za registracijo zdravila zaradi povračila, za pridobitev odobritve povračila ter za proizvodnjo in začetek prodaje zdravila. | 187 | Such a change would have entailed requesting a major variation, known as ‘type II’, within the meaning of Article 3 of Commission Regulation (EC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State (OJ 1995 L 55, p. 7), which is the procedure used for the variation of an existing MA, as a result of a change of API producer. A type II variation is the most laborious to obtain, necessitating the use of a procedure equivalent to that applicable to a new MA application. The total duration of that procedure can be up to 19 months. Furthermore, in addition to the time necessary to obtain such a variation, there is the time needed to research and develop the new process, to register the medicinal product for reimbursement, to obtain reimbursement approval, and to produce and start selling the medicinal product. |
| 188 | Komisija te trditve zavrača. | 188 | The Commission disputes those arguments. |
| 189 | Na prvem mestu, tožeči stranki napačno menita, da ni nobenega poslovno uspešnega in neponarejenega postopka, ki bi dopuščal vstop na trg med trajanjem spornih sporazumov. | 189 | In the first place, the applicants wrongly assert that no commercially viable and non-infringing procedure would have allowed market entry during the term of the agreements at issue. |
| 190 | Kot je navedeno v točki 150 obrazložitve izpodbijanega sklepa je namreč družba Lundbeck sprva v odgovoru na zahtevo Komisije za informacije pred obvestilom o ugotovitvah o možnih kršitvah menila, da bi generična podjetja lahko proizvedla generični citalopram po postopkih, opisanih v njenih izvirnih patentih (torej postopkih cianacije in alkilacije), ali z iznajdbo druge vrste postopka, tako da njeni patenti niso mogli preprečiti vsakršne konkurence generičnih podjetij. | 190 | As indicated in recital 150 of the contested decision, Lundbeck itself initially stated, in response to the Commission’s requests for information preceding the statement of objections, that the generic undertakings could have produced generic citalopram by using the procedures described in its original patents (that is to say, the cyanation and alkylation processes) or by inventing a new type of process, with the result that its patents were not capable of preventing all competition by the generic undertakings. |
| 191 | Poleg tega je družba Lundbeck potrdila, da njeni novi patenti niso mogli onemogočiti vsakršnih možnosti vstopa na trg, čeprav se je zdel postopek na podlagi kristalizacije najučinkovitejši. Komisija je tako na primer v točki 163 obrazložitve izpodbijanega sklepa ugotovila, da je družba Niche Generics Ltd vstopila na trg s pridobitvijo izjave o neobstoju kršitve za generični citalopram drugega indijskega proizvajalca AFU, in sicer družbe Sekhsaria. Poleg tega iz dokazov, navedenih v točki 634 obrazložitve izpodbijanega sklepa, izhaja, da so patentni strokovnjaki družbe Lundbeck marca 2002 izjavili, da „je mogoče proizvesti AFU, ki zelo verjetno ne zahteva kristalizacije proste baze“, torej tako AFU, ki ne temelji na patentu za kristalizacijo družbe Lundbeck. Tudi podpredsednik družbe Lundbeck je v svojem sporočilu za javnost z dne 9. novembra 2002 izjavil, da „bi bilo naivno misliti, da proizvajalci generičnih kopij ne morejo proizvesti Cipramila brez kršitve našega patenta“ (točka 634 obrazložitve izpodbijanega sklepa). | 191 | In addition, Lundbeck itself confirmed that its new process patents were not capable of blocking all possibilities of entering the market, even though the crystallisation-based process seemed to be the most effective. Thus, by way of example, the Commission noted, in recital 163 of the contested decision, that Niche Generics Ltd had entered the market by obtaining a declaration of non-infringement for the generic citalopram supplied by another Indian API producer, Sekhsaria. It can also be seen from the evidence referred to in recital 634 of the contested decision that, in March 2002, Lundbeck’s patent experts declared that ‘it [was] possible to make an [API] that very probably does not require crystallisation of the free base’, i.e. which was not based on Lundbeck’s crystallisation patent. Lundbeck’s Vice-President also stated in a press release of 9 November 2002 that ‘it would be naive to think that it is not possible for producers of generic copies to produce Cipramil without breaking our patent’ (recital 634 of the contested decision). |
| 192 | Tožeči stranki kljub temu trdita, da nista nikoli priznali, da bi bilo na eni strani mogoče uporabiti druge postopke za vstop na trg citaloprama brez kršenja njunih patentov, ali z varnimi zdravili, proizvedenimi v industrijskem obsegu, na drugi. | 192 | The applicants submit, nevertheless, that they have never acknowledged that other processes could be used to enter the citalopram market without infringing their patents or with safe medicinal products produced on an industrial scale. |
| 193 | Vendar je treba, prvič, spomniti na to, da se v času sklenitve spornih sporazumov nobeno sodišče EGP ni izreklo o tem, ali proizvodi, ki so jih razvila generična podjetja, pomenijo kršitev (glej točko 146 zgoraj). Zato tožeči stranki ne moreta utemeljeno trditi, da so bili z generičnimi zdravili, ki so jih razvila generična podjetja, kršeni njuni patentirani postopki, saj so kvečjemu pomenili potencialno kršitev v času sklenitve spornih sporazumov. | 193 | However, it must be recalled, first, that at the time the agreements at issue were concluded, no court in the EEA had ruled on the infringing nature of products developed by the generic undertakings (see paragraph 146 above). The applicants cannot validly argue, therefore, that the generic medicinal products developed by the generic undertakings infringed its process patents, when they were, at most, potentially infringing at the time the agreements at issue were concluded. |
| 194 | Drugič, kot navaja Komisija, dejstva ne podpirajo trditve, da industrijsko ne bi bilo mogoče razviti nobene neponarejene različice generičnega citaloprama. Na eni strani je treba spomniti, da bi se lahko kateri koli proizvajalec AFU oprl na izvirna postopka cianacije in alkilacije, ki sta bila objavljena skupaj s patentom za AFU citalopram družbe Lundbeck, ki je potekel (točka 16 zgoraj). Iz točke 158 obrazložitve izpodbijanega sklepa tako izhaja, da je svetovalec družbe Lundbeck v sporu Lagap, ki se je nanašal na citalopram družbe Matrix, priznal, da je bilo mogoče postopke, vsebovane v izvirnih patentih, razviti ekonomično, brez navedbe kakršnega koli roka v zvezi s tem, da je vse odvisno od načina izvedbe cianacije, in da je družba Matrix „cianacijo izvajala učinkovitejše kot so mislili da lahko“, kar kaže na to, da je bilo generični citalopram mogoče industrijsko proizvesti na podlagi izvirnih patentov družbe Lundbeck. | 194 | Secondly, as the Commission submits, the assertion that there was no non-infringing version of generic citalopram capable of being developed on an industrial scale is not supported by the facts. It must be borne in mind that any API producer could have used the original cyanation and alkylation processes as published with the patent on Lundbeck’s citalopram API, which had expired (paragraph 16 above). Thus, it can be seen from recital 158 of the contested decision that, in the context of the Lagap litigation, which concerned the Matrix citalopram, Lundbeck’s counsel acknowledged that it was possible that the processes set out in its original patents could be developed economically, without specifying any period in that respect, that it would depend on the manner in which the cyanation was carried out and that Matrix ‘[did] the cyanation more efficiently that we [had] believed that they could do it’, which shows that it was possible to produce generic citalopram on an industrial scale using Lundbeck’s original patents. |
| 195 | Vsekakor pa je v izpodbijanem sklepu zadostno dokazano, da je vsako generično podjetje imelo ali bi v dovolj kratkem času lahko imelo generično različico citaloprama na podlagi postopkov, za katere ni bilo dokazano, da se z njimi v času sklenitve spornih sporazumov krši kateri koli patent družbe Lundbeck. | 195 | In any event, the contested decision sufficiently establishes that each generic undertaking had, or could have obtained within a sufficiently short time, a generic version of citalopram based on processes which had not been held to infringe any of Lundbeck’ patents at the time the agreement were concluded. |
| 196 | Tako je citalopram družbe Natco, ki ga je uporabljalo podjetje Merck (GUK), temeljil na postopkih, zajetih z izvirnimi patenti družbe Lundbeck, ki so potekli, ali na drugih postopkih, katerih patenti so prav tako potekli (točki 228 in 281 obrazložitve izpodbijanega sklepa). Dobaviteljska pogodba med podjetjem Merck (GUK) in družbo Schweizerhall je izrecno določala, da AFU družbe Natco po njunem vedenju ni ponaredek (točka 235 obrazložitve izpodbijanega sklepa). Poleg tega je treba izpostaviti, da patent za kristalizacijo v času sklenitve sporazuma GUK za Združeno kraljestvo na dan 24. januarja 2002 niti v Združenem kraljestvu niti nikjer drugje v EGP še ni bil podeljen (glej točko 20 zgoraj). Vprašanje, ali se je s postopkom družbe Natco kršil patent za kristalizacijo, je bilo torej v času sklenitve navedenega sporazuma zgolj hipotetično. EPU je družbi Lundbeck ob sklenitvi sporazuma GUK za EGP resda že podelil patent za kristalizacijo, vendar ni bilo gotovo, da je AFU družbe Natco ponaredek, niti da bi bila veljavnost navedenega patenta potrjena v primeru spora (glej točko 122 zgoraj). | 196 | Thus, Natco citalopram, used by Merck (GUK), was based on processes covered by Lundbeck’s original patents, which had expired, or on other processes covered by patents which had also expired (recitals 228 and 281 of the contested decision). The supply contract concluded between Merck (GUK) and Schweizerhall expressly provided that the Natco API was, to their knowledge, non-infringing (recital 235 of the contested decision). In addition, it must be noted that, at the time the GUK United Kingdom agreement was concluded, on 24 January 2002, the crystallisation patent had not yet been issued, either in the United Kingdom or throughout the EEA (see paragraph 20 above). The question whether the Natco process potentially infringed the crystallisation patent was therefore only a hypothetical question at the time that agreement was concluded. It is true that, when the GUK EEA agreement was concluded, Lundbeck’s crystallisation patent had already been granted by the EPO, but it was in no way certain that the Natco API was infringing or that the validity of that patent would have been upheld in the event of litigation (see paragraph 122 above). |
| 197 | Sicer pa bi lahko podjetje Merck (GUK), tudi če bi družba Lundbeck vložila tožbe zaradi kršitev zoper podjetje Merck (GUK) in bi se izkazalo, da so proizvodi zadnjenavedenega ponaredki, kljub temu v razumnem roku pridobilo neponarejeni citalopram iz drugih virov. Čeprav je namreč podjetje Merck (GUK) sklenilo dobaviteljsko pogodbo z družbo Schweizerhall za osem let, je ta sporazum temeljil na hipotezi, da proizvod družbe Natco ni ponaredek (točka 235 obrazložitve izpodbijanega sklepa), tako da bi podjetje Merck (GUK) nedvomno lahko ta sporazum ob kršitvi odpovedalo, bodisi na podlagi izrecnih določb tega sporazuma bodisi na podlagi nemškega prava, ki se je uporabljalo za to pogodbo. Še posebej pa iz točk 248 in 351 obrazložitve izpodbijanega sklepa izhaja, da so obstajali drugi viri generičnega citaloprama na trgu, za katere je podjetje Merck (GUK) vedelo, zlasti prek družbe Merck dura GmbH, hčerinske družbe podjetja Merck (GUK) v Nemčiji. Vsekakor pa ni izključeno, tudi če bi bilo podjetje Merck (GUK) na podlagi sporazuma Schweizerhall zavezano, da se oskrbuje izključno pri družbi Natco in da bi se z generičnim citalopramom zadnjenavedene kršil patent za kristalizacijo, da bi lahko družba Natco proizvajala AFU citalopram po drugih neponarejenih postopkih, kot utemeljeno ugotavlja Komisija v točki 746 obrazložitve izpodbijanega sklepa. | 197 | Moreover, even if Lundbeck had brought infringement actions against Merck (GUK) and the latter’s products had been found to be infringing, Merck (GUK) would nevertheless have been able to obtain citalopram which had not been held to be infringing from other sources within a reasonable period. Although Merck (GUK) had concluded a supply agreement with Schweizerhall for a period of eight years, that agreement was based on the assumption that Natco’s product was non-infringing (recital 235 of the contested decision), with the result that Merck (GUK) would probably have been able to terminate that agreement in the event of infringement, whether on the basis of the express provisions of that agreement or pursuant to German law, the law applicable to that contract. It can be seen, inter alia, from recitals 248 and 351 of the contested that there were other sources of generic citalopram on the market, of which Merck (GUK) was aware, through, inter alia, Merck dura GmbH, Merck’s subsidiary in Germany. In any event, even if Merck (GUK) had been bound, under the Schweizerhall agreement, to use Natco as its exclusive supplier and the generic citalopram produced by the latter infringed the crystallisation patent, it is possible that Natco could have produced the citalopram API using other non-infringing processes, as the Commission rightly pointed out in recital 746 of the contested decision. |
| 198 | V zvezi z generičnim citalopramom, ki ga je družba Tiefenbacher dobavljala podjetjema Arrow in Alpharma, je treba ugotoviti, da je bil ta sprva proizveden po postopku Cipla I (v nadaljevanju: postopek Cipla I), za katerega je sicer obstajalo tveganje kršenja, vendar bi ga lahko družba Tiefenbacher preprosto zamenjala s citalopramom družbe Matrix, ki je bil sprva proizveden po postopku Matrix I, nato pa po novem postopku, ki ga je uporabljala družba Matrix (v nadaljevanju: postopek Matrix II). Spomniti pa je treba, da nobeno sodišče v EGP v času sklenitve spornih sporazumov ni ugotovilo, da postopka Cipla I in Matrix I pomenita kršitev (točka 146 zgoraj). | 198 | As regards the generic citalopram supplied by Tiefenbacher to Arrow and to Alpharma, it must be noted that, although that generic citalopram was initially produced using Cipla’s initial process (‘the Cipla I process’), in respect of which there was a risk of infringement, Tiefenbacher could have easily switched to Matrix citalopram, produced initially in accordance with Matrix’s initial process (‘the Matrix I process’) and subsequently in accordance with the new process used by Matrix (‘the Matrix II process’). It must be recalled that the Cipla I and Matrix I processes had not been held to be infringing by any EEA court at the time the agreements at issue were concluded (paragraph 146 above). |
| 199 | V zvezi s postopkom Matrix II, ki je bil uporabljen pri proizvodnji generičnega citaloprama, do katerega sta lahko podjetji Arrow in Alpharma dostopali prek družbe Tiefenbacher, iz točk 154, 155, 421 in 674 obrazložitve ter opombe 1828 izpodbijanega sklepa izhaja, da je bil ta postopek razvit maja 2002, zato da bi se izognilo poznejšemu tveganju, da bi citalopram družbe Matrix kršil patent za kristalizacijo. Družba Lundbeck je v okviru spora Lagap po pregledu prostorov družbe Matrix v Indiji priznala, da se s postopkom Matrix II ne kršijo njeni patenti. Zato je – kot utemeljeno opozarja Komisija – brezpredmetno, da so pred navedenim priznanjem nekatera nacionalna sodišča ugodila predlogom za začasne ukrepe družbe Lundbeck v zvezi s tem postopkom. Podobno ni mogoče ničesar sklepati na podlagi okoliščine, da bi lahko zadevno podjetje za to, da bi njegovo DZP zajelo tudi postopek Matrix II, vložilo zgolj vlogo za manjšo spremembo tipa I v smislu člena 3 Uredbe št. 541/95 (v nadaljevanju: sprememba tipa I), ki se med drugim uporablja za spremembo obstoječega DZP zaradi spremembe postopka, ki ga uporablja proizvajalec AFU. Ta okoliščina namreč ne more ovreči priznanja družbe Lundbeck v okviru spora Lagap, da ta postopek, ki ga je sicer pozneje uporabljalo več generičnih podjetij brez odziva družbe Lundbeck, ni pomenil kršitve. | 199 | As regards the Matrix II process, which was used to produce the generic citalopram to which Arrow and Alpharma could also have had access through Tiefenbacher, it follows from recitals 154, 155, 421 and 674 as well as footnote No 1828 of the contested decision that that process had already been developed in May 2002, in order to subsequently reduce the risk that the Matrix citalopram infringed the crystallisation patent. In the context of the Lagap litigation, following an inspection at Matrix’s premises in India, Lundbeck acknowledged that the Matrix II process did not infringe its patents. Accordingly, as the Commission rightly points out, it is immaterial that, before that admission, some national courts had granted Lundbeck’s requests for interim measures concerning that process. Likewise, no conclusion can be drawn from the fact that, in order to ensure that its MA also covers the Matrix II process, Tiefenbacher was able merely to file an application for a minor variation (type 1), within the meaning of Article 3 of Regulation No 541/95 (‘the type I variation’), which is the procedure used inter alia for the variation of an existing MA as a result of a modification of the process used by the same API producer. That circumstance does not call into question Lundbeck’s admission, in the Lagap litigation, of the non-infringing nature of that process which, moreover, was subsequently used by several generic undertakings without Lundbeck reacting. |
| 200 | Podobno velja za novi postopek, ki ga je za proizvodnjo generičnega citaloprama uporabljala družba Cipla (v nadaljevanju: postopek Cipla II) in ki je bil tudi načeloma dostopen prek družbe Tiefenbacher. Komisija je namreč izpostavila – zlasti v točki 898 obrazložitve izpodbijanega sklepa – da ta postopek, razvit v obdobju, ki ga zajemajo sporni sporazumi, potencialno ni bil ponarejen, v zvezi z njim pa je bila septembra 2002 vložena vloga za spremembo DZP tipa I. podjetji Arrow in Alpharma bi torej lahko poskušali prodajati citalopram, proizveden po tem postopku, tako kot je to storila družba Neolab, ne da bi jima družba Lundbeck lahko nasprotovala, kot je Komisija navedla v opombi 1671 izpodbijanega sklepa. | 200 | Similar remarks can be made as regards the new process used by Cipla in order to produce the generic citalopram (‘the Cipla II process’), which was also, in principle, accessible through Tiefenbacher. The Commission showed, particularly in recital 898 of the contested decision, that that process, which was developed during the period covered by the agreements at issue, was potentially non-infringing and had been the subject matter of an application for a type I variation of an MA in September 2002. Thus, Arrow and Alpharma could have sought to sell citalopram produced using that process, as Neolab did, without Lundbeck being able effectively to oppose them, as the Commission indicated in footnote No 1671 of the contested decision. |
| 201 | Kar zadeva, nazadnje, postopek, ki ga je uporabljalo podjetje Ranbaxy, je treba ugotoviti, da je družba Lundbeck, celo po tem, ko je proučila reakcijske sheme navedenega podjetja, želela z njim skleniti sporazum, ki bi določal obrnjena plačila, namesto da bi pri nacionalnih sodiščih skušala doseči začasne odredbe. Iz tega sledi, da družba Lundbeck ni bila prepričana o ponarejenosti AFU, proizvedene po tem postopku, kot izhaja iz točk 564 in 1109 obrazložitve izpodbijanega sklepa. Poleg tega je podjetje Ranbaxy tako v zvezi z družbo Lundbeck kot generičnimi podjetji, potencialno zainteresiranimi za nakup njegove AFU, trdilo da zadnjenavedena ni ponaredek, kot je Komisija med drugim navedla v točki 1105 obrazložitve izpodbijanega sklepa. | 201 | As regards, lastly, the process used by Ranbaxy, it should be noted that Lundbeck, even after having examined Ranbaxy’s reaction schemes, wished to conclude an agreement with it providing for reverse payments, instead of applying to national courts for injunctions. It follows that Lundbeck was uncertain as to whether the API produced using that process was infringing, as can be seen from recitals 564 and 1109 of the contested decision. In addition, Ranbaxy claimed, both as regards Lundbeck and the generic undertakings potentially interested in purchasing its API, that the latter was not infringing, as the Commission noted, inter alia, in recital 1105 of the contested decision. |
| 202 | Poleg tega je treba spomniti, da tudi če bi se s proizvodi, ki so jih tržila generična podjetja, kršil kateri koli od patentov družbe Lundbeck – kar v času sklenitve spornih sporazumov v obravnavani zadevi ni bilo dokazano – bi lahko tudi generična podjetja izpodbijala veljavnost teh patentov pri pristojnih sodiščih (glej točko 122 zgoraj). | 202 | Furthermore, it must be recalled that, even if the products sold by the generic undertakings had infringed one of Lundbeck’s patents, which was not established at the time of the conclusion of the agreements at issue in the present case, the generic undertakings would also have been able to challenge the validity of those patents before the competent courts (see paragraph 122 above). |
| 203 | Na drugem mestu, zavrniti je treba trditev tožečih strank, da bi Komisija morala dokazati, da se je zamenjava postopka ali proizvajalca AFU zgodila med trajanjem spornih sporazumov. Komisija je bila za to, da dokaže obstoj potencialne konkurence med generičnimi podjetji in družbo Lundbeck, zavezana dokazati samo to, da so prvonavedena imela dejanske in konkretne možnosti za vstop na trg v dovolj kratkem roku zaradi vršenja dejanskega konkurenčnega pritiska na družbo Lundbeck v času sklenitve spornih sporazumov. Komisiji ni bilo treba dokazati, da bi generična podjetja med trajanjem spornih sporazumov lahko nedvomno pridobila poslovno uspešen in neponarejen postopek, ampak samo to, da so imela v času sklenitve teh sporazumov dejanske in konkretne možnosti v zvezi s tem, in da te možnosti niso bile zgolj teoretične. | 203 | In the second place, it is necessary to reject the applicants’ argument that the Commission should have demonstrated that moving to another process or to another API producer would have taken place during the duration of the agreements at issue. In order to establish the existence of potential competition between the generic undertakings and Lundbeck, the Commission was only required to show that they had real concrete possibilities of entering the market within a sufficiently short period to exert effective competitive pressure on Lundbeck at the time the agreements at issue were concluded. The Commission was not required to demonstrate that the generic undertakings would undoubtedly have been able to obtain a commercially viable and non-infringing process during the term of the agreements at issue, but only that they had real concrete possibilities in that respect, at the time of concluding those agreements, and that those possibilities were not purely theoretical. |
| 204 | Tožeči stranki pa ne zanikata, da so generična podjetja lahko spremenila obstoječe DZP ali zamenjale proizvajalca AFU v primeru večjega tveganja kršitve, vendar trdita, da bi to lahko trajalo več mesecev ali celo dlje kot so trajali sporni sporazumi. Ne moreta pa zahtevati, da Komisija dokaže kaj bi se zgodilo, če spornih sporazumov ne bi bilo, ko pa so v času njihove sklenitve obstajale številne možnosti za vstop generičnih podjetij na trg. Možnost spremembe obstoječega DZP ali pridobitev AFU drugega dobavitelja nista bili zgolj teoretični, kot kažejo dokazi, ki so v zvezi s tem v izpodbijanem sklepu navedeni za vsako generično podjetje (glej od šestega do devetega dela spodaj). Tožeči stranki sta na primer priznali, da bi družba Tiefenbacher kot posrednik za podjetji Arrow in Alpharma lahko na Nizozemskem v samo dveh mesecih in pol dosegla spremembo tipa I njenega DZP za citalopram družbe Matrix (točka 418 obrazložitve izpodbijanega sklepa). | 204 | The applicants do not deny that it was possible, for the generic undertakings, to vary an existing MA or to switch to another API producer in the event of an increased risk of infringement, but submit that this could have taken several months, or even longer than the term of the agreements at issue. They cannot, however, require the Commission to show what would have happened in the absence of the agreements at issue, in a context where numerous options were open to the generic undertakings in order to enter the market, at the time those agreements were concluded. The possibility of altering an existing MA or of obtaining the API from another supplier was not a purely theoretical possibility, as shown by the evidence set out in the contested decision, as regards each generic undertaking, in that respect (see the sixth to ninth parts below). The applicants themselves have acknowledged, for example, that Tiefenbacher, acting as an intermediary for Arrow and Alpharma, had obtained a type I variation of its MA issued for the Matrix citalopram in only two and a half months in the Netherlands (recital 418 of the contested decision). |
| 205 | Vsekakor pa taka možnost za večino generičnih podjetij verjetno niti ni bila potrebna za njihov vstop na trg, še manj pa za vršenje konkurenčnega pritiska na družbo Lundbeck, ker so izvedla potrebne ukrepe in v nekaterih primerih celo že pridobila DZP za vstop na trg z generičnim citalopramom svojega dobavitelja (ali v primeru podjetja Ranbaxy svojim lastnih generičnim citalopramom) in ker nobeno sodišče v času sklenitve spornih sporazumov tega ni razglasilo za ponaredek. Poleg tega je to – kar je bilo že ugotovljeno zgoraj v točki 181 – da je družba Lundbeck sklenila sporne sporazume z generičnimi podjetji, pomemben indic za to, da jih je dojemala kot potencialno grožnjo, ki vrši konkurenčni pritisk na njen tržni položaj. | 205 | In any event, that possibility was probably not even necessary for most generic undertakings in order to be able to enter the market, and even less so in order to be able to exert a competitive pressure on Lundbeck, since they were taking the necessary steps and had even, in certain cases, already obtained an MA in order to enter the market with the generic citalopram of their supplier (or their own generic citalopram in Ranbaxy’s case), which had not been declared infringing by any court at the time the agreements at issue were concluded. Moreover, as was already noted in paragraph 181 above, the very fact that Lundbeck concluded the agreements at issue with the generic undertakings constitutes an important indication that it perceived them as a potential threat exerting a competitive pressure on its position on the market. |
| 206 | Zato je treba peti del zavrniti. | 206 | The fifth plea in law must therefore be rejected. |
| H – Šesti del: odsotnost potencialne konkurence med družbo Lundbeck in podjetjem Merck (GUK) v času sklenitve spornih sporazumov | H – The sixth part, alleging the absence of potential competition between Lundbeck and Merck (GUK) at the time the agreements at issue were concluded |
| 207 | Tožeči stranki trdita, da je v izpodbijanem sklepu napačno ugotovljeno, da je bilo podjetje Merck (GUK) v času zatrjevane kršitve potencialni konkurent družbe Lundbeck v Združenem kraljestvu in mutatis mutandis v EGP. | 207 | The applicants claim that the contested decision was wrong to find that Merck (GUK) was a potential competitor of Lundbeck in the United Kingdom and, mutatis mutandis, in the EEA at the time of the alleged infringement. |
| 208 | Menita, da je sicer lahko upoštevno, ali je podjetje Merck (GUK) nameravalo vstopiti na trg, vendar pa je treba preizkusiti predvsem, ali je bilo tega zmožno. V izpodbijanem sklepu naj bi bilo spregledano, da je imelo podjetje Merck (GUK) dostop samo do citaloprama družbe Natco, s katerim se je kršil patent družbe Lundbeck za kristalizacijo, kar naj bi pomenilo, da ni bilo sposobno zakonito vstopiti na trg. | 208 | They maintain that, while GUK’s intention to enter the market may be relevant, the key test is whether it was actually able to enter the market. The contested decision obscures the fact that Merck (GUK) had access only to Natco’s citalopram, which infringed Lundbeck’s crystallisation patent, which means that it was not able to enter the market lawfully. |
| 209 | Poleg tega naj bi bilo v točki 754 obrazložitve izpodbijanega sklepa na podlagi dokumentov iz časa dejanskega stanja napačno ugotovljeno, da je bilo podjetje Merck (GUK) zelo prepričano v svoj položaj na področju patentov. Tožeči stranki menita, da je Komisija te dokumente navajala selektivno in jih vzela iz konteksta. | 209 | In addition, the contested decision is wrong to have found, in recital 754, on the basis of contemporaneous documents, that Merck (GUK) was very sure of its patent position. The applicants maintain that the Commission quoted those documents selectively and took them out of context. |
| 210 | Sicer pa podjetje Merck (GUK) po mnenju tožečih strank ni bilo potencialni konkurent družbe Lundbeck, ker v času trajanja spornih sporazumov ni moglo zamenjati AFU s tistimi, ki so bile proizvedene po neponarejenih postopkih. Leta 2003 naj namreč ne bi obstajal noben drug poslovno uspešen neponarejen generični proizvod. Vsekakor pa naj bi bil, tudi če bi podjetje Merck (GUK) lahko zamenjalo proizvajalca s tistim, ki proizvaja neponarejeno AFU, s tem, da je podjetje Merck (GUK) pridobilo citalopram pri tretjih osebah, kršen člen 1.3 sporazuma med njim in družbo Schweizerhall, po katerem naj bi podjetje Merck (GUK) pokrilo 100 % svojega letnega povpraševanja po AFU citalopram pri družbi Schweizerhall (točka 235 obrazložitve izpodbijanega sklepa). | 210 | Furthermore, in the applicants’ submission, Merck (GUK) was not a potential competitor of Lundbeck, since it could not have switched to other APIs produced using non-infringing processes during the term of the agreements at issue. In 2003, no other commercially viable non-infringing generic product existed. In any event, on the assumption that Merck (GUK) could have switched to other producers of non-infringing API, if Merck (GUK) had acquired citalopram from third parties it would have been in breach of Article 1.3 of its agreement with Schweizerhall, which provided that Merck (GUK) was to cover 100% of its annual demand for citalopram API with Schweizerhall (recital 235 of the contested decision). |
| 211 | Nazadnje, tožeči stranki menita, da v izpodbijanem sklepu ni obrazložena ugotovitev, da je bilo podjetje Merck (GUK) v času zatrjevane kršitve potencialni konkurent družbe Lundbeck v EGP (razen v Združenem kraljestvu). Ker je bila globa, naložena družbi Lundbeck, v izpodbijanem sklepu izračunana na podlagi vrednosti prodaje citaloprama v celotnem EGP, naj bi že samo ta dejavnik zadostoval za razveljavitev izpodbijanega sklepa. | 211 | Lastly, the applicants maintain that the contested decision does not state the reasons for its finding that Merck (GUK) was a potential competitor of Lundbeck in the EEA (excluding the United Kingdom) at the time of the alleged infringement. Since the Commission, in the contested decision, calculated the fine imposed on Lundbeck on the basis of sales of citalopram throughout the EEA, that factor alone is sufficient to render the contested decision invalid. |
| 212 | Tožeči stranki v zvezi s prodajo citaloprama na Švedskem prek družbe NM Pharma (točke od 836 do 838 obrazložitve izpodbijanega sklepa), zaradi katere je Komisija ugotovila, da je bilo podjetje Merck (GUK) resen potencialni konkurent tudi na drugih trgih EGP (točka 840 obrazložitve), trdita, da to, da sta se selektivno odločili za sodno pot na Švedskem, ne da bi sprožili postopke zoper družbo NM Pharma, ne dokazuje, da je imelo podjetje Merck (GUK) dejansko in konkretno sposobnost ali možnost za vstop na druge trge EGP. V izpodbijanem sklepu naj ne bi bilo zadostno dokazano, da je bilo podjetje Merck (GUK) dejanski ali potencialni konkurent družbe Lundbeck v vseh državah EGP, ker je imelo pred sklenitvijo sporazuma GUK za EGP samo DZP na Švedskem. Podjetje Merck (GUK) naj bi DZP v Nemčiji, Italiji, na Nizozemskem in v Španiji pridobilo šele po poteku sporazuma GUK za EGP, drugje pa med trajanjem tega sporazuma. | 212 | As regards sales of citalopram in Sweden via NM Pharma (recitals 836 to 838 of the contested decision), which led the Commission to find that Merck (GUK) was a serious potential competitor, including on other EEA markets (recital 840), the applicants claim that the fact that they chose to litigate selectively in Sweden, without initiating proceedings against NM Pharma, does not prove that Merck (GUK) had the ability to enter other markets in the EEA or real concrete possibilities of doing so. The contested decision does not show to the requisite standard that Merck (GUK) was an actual or potential competitor of Lundbeck in all EEA countries, since the only country in which it had an MA before the conclusion of the GUK EEA agreement was Sweden. Merck (GUK) obtained an MA in Germany, Italy, the Netherlands and Spain only after the expiry of the GUK EEA agreement, and did so elsewhere while that agreement was in force. |
| 213 | Komisija te trditve zavrača. | 213 | The Commission disputes those arguments. |
| 214 | Pred obravnavanjem trditev tožečih strank je treba na kratko spomniti na analizo potencialne konkurence med podjetjem Merck (GUK) in družbo Lundbeck, ki jo je Komisija opravila v izpodbijanem sklepu. Komisija je v zvezi s tem razlikovala med položajem v Združenem kraljestvu v času sklenitve sporazuma GUK za Združeno kraljestvo na eni strani in položajem v EGP v času sklenitve sporazuma GUK za EGP na drugi. | 214 | It is appropriate, before examining the applicants’ arguments, to briefly recall the examination of the potential competition between Merck (GUK) and Lundbeck carried out by the Commission in the contested decision. The Commission made a distinction, in that respect, between the prevailing situation in the United Kingdom at the time the GUK United Kingdom agreement was concluded, on the one hand, and the prevailing situation in the EEA at the time the GUK EEA agreement was concluded, on the other. |
| 1. Položaj v Združenem kraljestvu | 1. The situation in the United Kingdom |
| 215 | Kar zadeva najprej konkurenčni položaj v Združenem kraljestvu, je Komisija ugotovila, da je bila družba Lundbeck pred 24. januarjem 2002, ko je bil podpisan sporazum GUK za Združeno kraljestvo, edino podjetje, ki je prodajalo citalopram v Združenem kraljestvu. Izvirni patenti družbe Lundbeck v Združenem kraljestvu so potekli 5. januarja 2002. Od takrat naprej je bil torej trg citaloprama v Združenem kraljestvu načeloma odprt za generične proizvode, če so upoštevali pravne zahteve v zvezi s kakovostjo, varnostjo in zanesljivostjo, kar se potrjuje z DZP. Zato je bilo mogoče podjetja, ki so proizvajala ali nameravala prodajati proizvode iz generičnega citaloprama v Združenem kraljestvu in so imela dejansko možnost, da v bližnji prihodnosti pridobijo generični citalopram in DZP, obravnavati kot potencialne konkurente družbe Lundbeck. Vstop generikov, zlasti ob hkratnem vstopu več generičnih podjetij, bi zelo verjetno ustvaril intenziven proces cenovne konkurence, s katero bi se cene citaloprama hitro in znatno znižale (točka 738 obrazložitve izpodbijanega sklepa). | 215 | As regards, first of all, the competitive situation in the United Kingdom, the Commission found that in the period preceding 24 January 2002, the date on which the GUK United Kingdom agreement was signed, Lundbeck was the only undertaking selling citalopram in the United Kingdom. On 5 January 2002, Lundbeck’s original patents expired in the United Kingdom. From that date, the citalopram market in the United Kingdom was therefore in principle open to generic products, provided that they complied with the legal requirement in relation to quality, safety and efficacy, as confirmed by an MA. Accordingly, undertakings manufacturing or intending to sell genetic citalopram products in the United Kingdom which had a realistic prospect of obtaining supplies of generic citalopram and acquiring an MA in the near future could be regarded as potential competitors of Lundbeck. The market entry of generics, in particular by several generic undertakings simultaneously, would in all probability have generated an intense process of price competition that would have reduced citalopram prices quickly and steeply (recital 738 of the contested decision). |
| 216 | Podjetje Merck (GUK) je bilo, potem ko je družbo Lundbeck obvestilo o svoji nameri vstopiti na trg citaloprama, prvo generično podjetje, ki je pridobilo DZP za trg Združenega kraljestva, in sicer 9. januarja 2002. Medtem je podjetje Merck (GUK) nabralo zalogo 8 milijonov tablet citaloprama na podlagi AFU družbe Natco, pripravljenih za prodajo v Združenem kraljestvu (točka 741 obrazložitve izpodbijanega sklepa). | 216 | Merck (GUK), after informing Lundbeck of its intention to enter the citalopram market, was the first generic undertaking to obtain an MA for the United Kingdom market, on 9 January 2002. During that period, Merck (GUK) had assembled a stock of 8 million citalopram tablets made from Natco API, ready for sale in the United Kingdom (recital 741 of the contested decision). |
| 217 | Podjetje Merck (GUK) po tem, ko je z družbo Lundbeck 24. januarja 2002 podpisalo sporazum GUK za Združeno kraljestvo, generičnega citaloprama ni dalo na trg do konca trajanja sporazuma, ki je bilo sprva določeno do julija 2003. Kljub temu pa je podjetje Merck (GUK) med 1. in 4. avgustom 2003, preden je bil sporazum 6. avgusta 2003 drugič podaljšan, v Združenem kraljestvu dejansko prodalo za 3,3 milijona GBP svojega generičnega citaloprama (točka 742 obrazložitve izpodbijanega sklepa). | 217 | Following the conclusion of the GUK United Kingdom agreement with Lundbeck on 24 January 2002, Merck (GUK) abstained from launching generic citalopram on the market until the end of the term of the agreement, which was initially planned for July 2003. Nevertheless, between 1 and 4 August 2003, before the agreement was extended for a second time on 6 August 2003, Merck (GUK) indeed sold generic citalopram in the United Kingdom corresponding to GBP 3.3 million (recital 742 of the contested decision). |
| 218 | Komisija je v točki 743 obrazložitve izpodbijanega sklepa ugotovila, da ta dejstva zadostno dokazujejo, da je imelo podjetje Merck (GUK) v času podpisa sporazuma GUK za Združeno kraljestvo dejanske in konkretne možnosti za vstop na trg citaloprama v Združenem kraljestvu. Še več, to, da je podjetje Merck (GUK) avgusta 2003 dejansko na kratko vstopilo na trg, naj bi zadostno dokazovalo, da sta bila podjetje Merck (GUK) in družba Lundbeck v času podpisa spornih sporazumov januarja 2002 potencialna konkurenta. Poleg tega naj bi zgolj dejstvo, da je družba Lundbeck v skladu s temi sporazumi privolila v prenos velike vrednosti na podjetje Merck (GUK), zadostno dokazovalo, da je družba Lundbeck dojemala podjetje Merck (GUK) kot potencialnega konkurenta, katerega vstop na trg je bil mogoč in ki je pomenil grožnjo njenemu položaju na trgu v času podpisa spornih sporazumov. | 218 | The Commission concluded, in recital 743 of the contested decision, that those facts sufficiently demonstrated that Merck (GUK) had real concrete possibilities of entering the citalopram market in the United Kingdom at the time the GUK United Kingdom agreement was concluded. In addition, according to the Commission, the fact that Merck (GUK) actually briefly entered the market in August 2003 sufficiently demonstrated that Merck (GUK) and Lundbeck were potential competitors at the time the agreements at issue were concluded in January 2002. Furthermore, the very fact that Lundbeck agreed to transfer considerable value to Merck (GUK) under those agreements sufficiently demonstrated that Lundbeck perceived Merck (GUK) as a potential competitor, the market entry of which was plausible, and which constituted a threat to its position on the market at the time the agreements at issue were concluded. |
| 219 | Vendar tožeči stranki nasprotujeta temu, da navedeni elementi zadostujejo kot dokaz za obstoj potencialne konkurence med njima in podjetjem Merck (GUK), in menita, da bi morala Komisija dokazati predvsem sposobnost zadnjenavedenega, da vstopi na trg, ne pa da upošteva njegove namere v zvezi s tem. Izpodbijata tudi različne navedbe, ki jih je Komisija uporabila v izpodbijanem sklepu in so bile po njunem mnenju vzete iz konteksta in ne omogočajo dokazovanja, da se z AFU družbe Natco ni kršil noben patent družbe Lundbeck, zlasti patent za kristalizacijo. | 219 | The applicants nevertheless dispute that those factors are sufficient to establish the existence of potential competition between them and Merck (GUK) and argue that the Commission should have demonstrated, above all, Merck (GUK)’s capacity to enter the market instead of taking account of its intentions in that respect. They also call into question various statements used by the Commission in the contested decision which, in their view, were taken out of context and which were not capable of proving that the Natco API did not infringe any of Lundbeck’s patents and, in particular, the crystallisation patent. |
| 220 | Ugotoviti pa je treba, da se Komisija pri ugotavljanju obstoja potencialne konkurence med podjetjem Merck (GUK) in družbo Lundbeck ni oprla samo na njuno subjektivno presojo, ampak tudi na objektivne dejavnike, kot na primer to, da je podjetje Merck (GUK) v času sklenitve sporazuma GUK za Združeno kraljestvo sklenilo dobaviteljsko pogodbo z družbo Schweizerhall, po kateri se je oskrbelo s citalopramom družbe Natco, da je že ustvarilo veliko zalogo generičnega citaloprama, in da je 9. januarja 2002 pridobilo DZP v Združenem kraljestvu. | 220 | It suffices to note, however, that the Commission did not rely solely on the subjective assessments of Merck (GUK) and Lundbeck in order to establish the existence of potential competition between them, but rather on objective elements, such as the fact that Merck (GUK) had, at the time of concluding the GUK United Kingdom agreement, concluded a supply agreement with Schweizerhall, in order to obtain the Natco citalopram, that it had already assembled a large stock of generic citalopram and that it had obtained an MA in the United Kingdom on 9 January 2002. |
| 221 | Prvič, tožeči stranki kljub temu trdita, da podjetje Merck (GUK) ni moglo dati svojih generičnih proizvodov na trg, ne da bi kršilo njune patente. Ponovno pa gre za njuno subjektivno presojo, saj v času sklenitve sporazuma GUK za Združeno kraljestvo nobeno sodišče v EGP ni ugotovilo, da se z AFU družbe Natco, ki jo je podjetje Merck (GUK) uporabljalo pri proizvodnji svojega generičnega citaloprama, krši kateri koli patent družbe Lundbeck. Poleg tega patent družbe Lundbeck za kristalizacijo v času sklenitve tega sporazuma v Združenem kraljestvu sploh še ni bil podeljen. Nazadnje, spomniti je treba, da podjetju Merck (GUK) ni bilo treba dokazati, da njegovi proizvodi niso ponarejeni, da bi jih lahko tržilo v Združenem kraljestvu (glej točko 122 zgoraj). Tvegalo je kvečjemu predloge družbe Lundbeck za izdajo začasnih odredb ali njene tožbe zaradi kršitev, brez zagotovila, da bo ta uspela, ker je bil po lastni presoji družbe Lundbeck obstoj kršitve patentiranih postopkov še posebej težko dokazati (točka 629 obrazložitve izpodbijanega sklepa). Poleg tega bi lahko v primeru spora z nasprotno tožbo izpodbijalo veljavnosti patentov družbe Lundbeck (glej točko 122 zgoraj). | 221 | In the first place, the applicants nevertheless argue that Merck (GUK) would not have been able to launch its generic products on the market without infringing their patents. However, that is again their subjective assessment, since, at the time the GUK United Kingdom agreement was concluded, no court in the EEA had declared that the Natco API, used by Merck (GUK) to produce its generic citalopram, infringed any of Lundbeck’s patents. Moreover, at the time that agreement was concluded, Lundbeck’s crystallisation patent had not yet been granted in the United Kingdom. Lastly, it must be recalled that Merck (GUK) did not have to prove that its products were non-infringing in order to be able to market them in the United Kingdom (see paragraph 122 above). It risked, at most, having to face applications for injunctions or infringement actions brought by Lundbeck, without it being in any way certain, however, that the latter would succeed, since, according to Lundbeck’s own estimations, the infringement of process patents was particularly difficult to establish (recital 629 of the contested decision). In addition, it could, in the event of litigation, have challenged the validity of Lundbeck’s patents, by raising a counter-claim (see paragraph 122 above). |
| 222 | Komisija v nasprotju s trditvami tožečih strank ni bila zavezana z gotovostjo dokazati, da bi podjetje Merck (GUK) med trajanjem sporazumov vstopilo na trg z AFU, s katero se ne bi kršil nobeden od patentov družbe Lundbeck. Dokazati je morala samo to, da je imelo podjetje Merck (GUK) v času sklenitve spornih sporazumov dejanske in konkretne možnosti za vstop na trg, in da te možnosti niso bile zgolj teoretične, ampak so bile posledica dejanske sposobnosti vstopa na trg v dovolj kratkem roku za konkurenčni pritisk na družbo Lundbeck. | 222 | Contrary to the applicants’ assertion, the Commission was not required to establish with certainty that Merck (GUK) would have entered the market, during the term of the agreements, using an API that did not infringe any of Lundbeck’s patents. The Commission was only required to prove that Merck (GUK) had real concrete possibilities of entering the market, at the time the agreements at issue were concluded, and that those possibilities were not purely theoretical but showed a real capacity to enter the market within a sufficiently short period to exert competitive pressure on Lundbeck. |
| 223 | Tožeči stranki pa ob upoštevanju dejavnikov iz točke 738 in naslednjih obrazložitve, kot so povzeti v točkah od 215 do 218 zgoraj, ne moreta utemeljeno trditi, da Komisija te naloge ni opravila. Dejstvo, da je podjetje Merck (GUK) avgusta 2003 lahko za kratek čas vstopilo na trg s svojimi generiki, ko je menilo, da pogoji njegovega sporazuma z družbo Lundbeck niso več dovolj dobri (točka 755 obrazložitve izpodbijanega sklepa), zgovorno priča o tem, da je bilo podjetje Merck (GUK) v času sklenitve sporazuma GUK za Združeno kraljestvo vsaj potencialni konkurent družbe Lundbeck. Sprejetje teze tožečih strank bi pomenilo, da celo takrat podjetja Merck (GUK) ni bilo mogoče obravnavati kot potencialnega konkurenta družbe Lundbeck, čeprav je v Združenem kraljestvu prodalo za 3,3 milijona GBP tablet. Take utemeljitve seveda ni mogoče sprejeti. Nazadnje, to, da je družba Lundbeck želela skleniti sporazum s podjetjem Merck (GUK), da bi odložila njegov vstop na trg, prav tako priča o tem, da ga je dojemala kot grožnjo, ki lahko vrši konkurenčni pritisk na trgu citaloprama v času sklenitve tega sporazuma (glej točko 103 zgoraj). | 223 | In view of the factors set out in recital 738 et seq. of the contested decision, as summarised in paragraphs 215 to 218 above, the applicants cannot validly argue that the Commission did not accomplish that task. The fact that Merck (GUK) was able to enter the market with its generics briefly, on August 2003, when it considered that the conditions of its agreement with Lundbeck were no longer good enough (recital 755 of the contested decision), shows in a striking manner that Merck (GUK) was at the very least a potential competitor of Lundbeck at the time the GUK United Kingdom agreement was concluded. If the applicants’ argument were accepted, it would mean that, even at that time, Merck (GUK) could not be considered a potential competitor of Lundbeck, since it had not been established that its products did not infringe any of Lundbeck’s patents, even though it had sold tablets corresponding to a value of GBP 3.3 million in the United Kingdom. Such arguments clearly cannot be upheld. Lastly, the fact that Lundbeck preferred to conclude an agreement with Merck (GUK) in order to delay the latter’s market entry also shows that it considered Merck (GUK) to be a threat capable of exerting competitive pressure on the citalopram market, at the time that agreement was concluded (see paragraph 103 above). |
| 224 | Drugič, v zvezi s trditvijo tožečih strank, da podjetje Merck (GUK) med trajanjem spornih sporazumov ni imelo možnosti zamenjati proizvajalca AFU, je treba ugotoviti, da je taka trditev glede na navedeno brezpredmetna, ker Komisiji ni bilo treba z gotovostjo dokazati, da bi podjetje Merck (GUK) vstopilo na trg z neponarejeno AFU, da bi se ga lahko v času sklenitve teh sporazumov obravnavalo kot potencialnega konkurenta družbe Lundbeck. Vsekakor pa je – kot utemeljeno navaja Komisija – dobaviteljska pogodba, ki jo je podjetje Merck (GUK) sklenilo z družbo Schweizerhall, temeljila na hipotezi, da AFU družbe Natco ne krši nobenega od patentov družbe Lundbeck po poteku njenih izvirnih patentov. Če bi bilo presojeno, da so proizvodi podjetja Merck (GUK) na podlagi AFU družbe Natco ponaredki, bi torej podjetje Merck (GUK) verjetno lahko odpovedalo to pogodbo in se oskrbelo z generičnim citalopramom pri drugem dobavitelju, kot je bila družba Schweizerhall, ali pa bi si skupaj z družbo Schweizerhall prizadevalo za dobavo generičnega citaloprama, proizvedenega z neponarejenimi postopki (točka 197 zgoraj). | 224 | In the second place, as regards the applicants’ arguments that Merck (GUK) would not have been able to switch to another API producer during the term of the agreements at issue, it must be pointed out that such an argument is ineffective, in view of the foregoing, since the Commission was not required to establish with certainty that Merck (GUK) would have entered the market with a non-infringing API in order to be able to regard it as a potential competitor of Lundbeck at the time those agreements were concluded. In any event, as the Commission rightly points out, the supply contract that Merck (GUK) had concluded with Schweizerhall was based on the premiss that the Natco API did not infringe any of Lundbeck’s patents after the expiry of its original patents. In the event that Merck (GUK)’s products, based on the Natco API, were held to be infringing, it is very likely, therefore, that Merck (GUK) would have been able either to terminate that contract and seek to obtain generic citalopram from a supplier other than Schweizerhall, or to work with Schweizerhall in order to procure generic citalopram, obtained using non-infringing processes (paragraph 197 above). |
| 225 | Zato Komisija ni storila napake z ugotovitvijo v izpodbijanem sklepu, da je imelo podjetje Merck (GUK) dejanske in konkretne možnosti za vstop na trg citaloprama v Združenem kraljestvu, in da je bilo zato takrat vsaj potencialni konkurent družbe Lundbeck. | 225 | Accordingly, the Commission did not err in concluding in the contested decision that Merck (GUK) had real concrete possibilities of entering the citalopram market in the United Kingdom at the time the GUK United Kingdom was signed, and that consequently it was at the very least a potential competitor of Lundbeck at that time. |
| 2. Položaj v EGP | 2. The situation in the EEA |
| 226 | Dalje, Komisija je v zvezi s konkurenčnim položajem v EGP v točki 827 in naslednjih navedla razloge, iz katerih je menila, da je podjetje Merck (GUK) mogoče obravnavati kot potencialnega konkurenta družbe Lundbeck v večini držav EGP. Podjetje Merck (GUK) je v času sklenitve sporazumov z družbo Schweizerhall sklenilo sporazum o izključni dobavi AFU družbe Natco. Zaradi tega sporazuma je bila družba Schweizerhall privilegiran distributer družbe Natco za več držav EGP (in sicer Nemčijo, Francijo, Finsko, Norveško, Švedsko, Belgijo, Španijo in Italijo), podjetje Merck (GUK) pa njena „privilegirana stranka“ v tem smislu, da so se njegove potrebe po citalopramu obravnavale prednostno (točka 235 obrazložitve izpodbijanega sklepa). | 226 | As regards, next, the competitive situation in the EEA, the Commission set out, in recitals 827 et seq., the reasons why it considered that Merck (GUK) could be regarded as a potential competitor of Lundbeck in most of the EEA States. At the time the agreements were signed, Merck (GUK) had concluded an exclusive distribution agreement with Schweizerhall covering the Natco API. Under that agreement Schweizerhall became the preferred supplier of Natco for a number of EEA States (namely Belgium, Germany, Spain, France, Italy, the Netherlands, Finland, Sweden and Norway) and Merck (GUK) became its ‘preferred customer’, meaning that its citalopram supply needs would be given priority (recital 235 of the contested decision). |
| 227 | Družba NK Pharma, distributer podjetja Merck (GUK) za Švedsko, je maja 2002 pridobila DZP in vstopila na švedski trg. Družba NM Pharma je imela tudi široko distribucijsko mrežo na Norveškem in je nameravala švedsko DZP po postopku medsebojnega priznavanja iz Direktive 2001/83 uporabiti za pridobitev DZP na Norveškem, Finskem, Danskem, Nizozemskem, v Belgiji in Španiji. Podjetje Merck (GUK) pa je z uporabo svojega DZP, ki ga je pridobilo v Združenem kraljestvu, nameravalo pridobiti taka DZP za Irsko, Francijo, Nemčijo, Avstrijo, Italijo, Portugalsko in Grčijo (točki 829 in 830 obrazložitve izpodbijanega sklepa). Poleg tega je bila v točki D preambule sporazuma GUK za EGP priznana vloga podjetja Merck (GUK) kot potencialnega konkurenta na ozemlju EGP (točka 831 obrazložitve izpodbijanega sklepa). | 227 | In May 2002, NM Pharma, Merck (GUK)’s distributor for Sweden, obtained an MA and entered the Swedish market. NM Pharma also had a strong distribution network in Norway and intended to use its Swedish MA to obtain MAs in Belgium, Denmark, Spain, the Netherlands, Finland and Norway through the mutual recognition procedure laid down in Directive 2001/83. Merck (GUK), for its part, intended to obtain similar MAs for Germany, Ireland, Greece, France, Italy, Austria and Portugal by using its MA obtained in the United Kingdom (recitals 829 and 830 of the contested decision). In addition, point D of the preamble to the GUK EEA agreement recognised Merck (GUK)’s role as a potential competitor in the EEA (recital 831 of the contested decision). |
| 228 | Komisija je na podlagi teh dejavnikov lahko ugotovila, da sta bila podjetje Merck (GUK) in družba Lundbeck v času podpisa sporazuma GUK za EGP oktobra 2002 vsaj potencialna konkurenta. Podjetje Merck (GUK) naj bi bilo prek svojega distributerja, družbe NM Pharma, na Švedskem nekaj mesecev pred podpisom sporazuma celo dejanski konkurent družbe Lundbeck. Sicer pa naj bi zgolj dejstvo, da je družba Lundbeck v skladu z navedenim sporazumom privolila v prenos velike vrednosti na podjetje Merck (GUK), pomenilo da je družba Lundbeck dojemala podjetje Merck (GUK) kot potencialnega konkurenta, katerega vstop na trg je bil mogoč in je pomenil grožnjo za njen položaj na trgu citaloprama v času podpisa sporazuma GUK za EGP (točka 832 obrazložitve izpodbijanega sklepa). | 228 | Those factors allowed the Commission to conclude that Merck (GUK) and Lundbeck were at the very least potential competitors at the time the GUK EEA agreement was signed in October 2002. Merck (GUK) was even an actual competitor of Lundbeck in Sweden for several months preceding the signing of the agreement, through its distributor NM Pharma. Moreover, the very fact that Lundbeck agreed to transfer considerable value to Merck (GUK) under that agreement sufficiently demonstrated that Lundbeck perceived Merck (GUK) as a potential competitor, the market entry of which was plausible, and which constituted a threat to its position on the market at the time the GUK EEA agreement was signed (recital 832 of the contested decision). |
| 229 | Tožeči stranki pa kljub temu trdita, da so trgi za dobavo farmacevtskih proizvodov, kakršen je citalopram, nacionalni, zato bi morala Komisija presoditi, ali sta bila podjetje Merck (GUK) in družba Lundbeck potencialna konkurenta v vsaki državi EGP, ne pa da je opravila enotno presojo za celoten EGP. | 229 | The applicants submit, however, that the product markets for the supply of pharmaceutical products such as citalopram are national in scope and that the Commission ought therefore to have ascertained whether Merck (GUK) and Lundbeck were potential competitors in each Member State of the EEA, instead of making a single assessment for the whole of the EEA. |
| 230 | Vendar je treba ugotoviti, da analiza Komisije iz točk od 827 do 840 obrazložitve izpodbijanega sklepa (glej točke od 226 do 228 zgoraj) dovolj prepričljivo dokazuje, da je mogoče podjetje Merck (GUK) in družbo Lundbeck obravnavati kot potencialna konkurenta na celotnem ozemlju EGP v času sklenitve sporazuma GUK za EGP. To, da podjetje Merck (GUK) niti v času sklenitve sporazuma GUK za EGP niti celo med njegovim trajanjem ni pridobilo DZP v vseh državah EGP, ne pomeni, da v času sklenitve tega sporazuma ni imelo dejanskih in konkretnih možnosti za vstop na trge različnih držav EGP. | 230 | It must be pointed out, however, that the analysis carried out by the Commission in recitals 827 to 840 of the contested decision (see paragraphs 226 to 228 above) shows in a sufficiently convincing manner that Merck (GUK) and Lundbeck could be regarded as potential competitors in the whole of the EEA at the time the GUK EEA agreement was concluded. The fact that Merck (GUK) had not obtained an MA in all the EEA States at the time the GUK EEA agreement was concluded, nor during the term of that agreement, does not mean that it did not have real concrete possibilities to enter the markets of various EEA States, at the time that agreement was concluded. |
| 231 | Kot je namreč Komisija pokazala v točki 827 in naslednjih obrazložitve izpodbijanega sklepa, je podjetje Merck (GUK) za pridobitev DZP v drugih državah članicah nameravalo uporabiti postopek medsebojnega priznavanja iz Direktive 2001/83 na podlagi svojega DZP, ki ga je že pridobilo v Združenem kraljestvu, in DZP svojega distributerja, družbe NM Pharma, na Švedskem (glej točko 227 zgoraj). | 231 | As the Commission demonstrated in recitals 827 et seq. of the contested decision, Merck (GUK) had intended to use the mutual recognition procedure laid down in Directive 2001/83 in order to obtain MAs in other Member States by using the MA it had already obtained in the United Kingdom and the MA of its distributor, NM Pharma, in Sweden (see paragraph 227 above). |
| 232 | Sicer pa dejstvo, da sporazum GUK za EGP obsega celotno ozemlje EGP (razen Združeno kraljestvo), zadostno dokazuje, da je družba Lundbeck dojemala podjetje Merck (GUK) kot potencialno grožnjo na tem celotnem ozemlju in da je imelo to dejanske in konkretne možnosti za vstop na trg citaloprama, če ne v vseh državah EGP pa vsaj v veliki večini (glej točko 827 in naslednje obrazložitve izpodbijanega sklepa). Kot je Komisija navedla v opombi 1540 izpodbijanega sklepa, ji ni bilo treba dokazati, da bi podjetje Merck (GUK), če ne bi bilo sporazuma GUK za EGP, v času trajanja tega sporazuma gotovo vstopilo na trg vsake države članice EGP. Za nazaj namreč ni mogoče rekonstruirati, kdaj bi vstopilo na trg v vsaki državi članici EGP, cilj in učinek sporazuma GUK za EGP pa je bil ravno prekinitev prizadevanj podjetja Merck (GUK) v zvezi s tem. | 232 | Furthermore, the fact that the GUK EEA agreement covered the whole EEA territory (with the exception of the United Kingdom), sufficiently demonstrates that Lundbeck perceived Merck (GUK) as a potential threat in the whole of that territory and that the latter had real concrete possibilities of entering the citalopram market, if not in all the EEA States, then at least in a large majority of them (see recitals 827 et seq. of the contested decision). As the Commission indicated in footnote No 1540 of the contested decision, it was not required to prove that, in the absence of the GUK EEA agreement, Merck (GUK) would undoubtedly have entered the market in each EEA Member State during the term of that agreement. It is not possible to reconstruct, ex post, the date on which Merck (GUK) would have entered the market in each EEA Member State, when the purpose and effect of the GUK EEA agreement was precisely to interrupt the efforts made by Merck (GUK) in that respect. |
| 233 | Poleg tega se s tako utemeljitvijo ponovno zanemarja razlikovanje med dejansko in potencialno konkurenco, pri čemer zadnjenavedena ne zahteva dokazovanja zanesljivega vstopa na trg, ampak samo obstoj dejanskih in konkretnih možnosti v zvezi s tem. Iz točk od 328 do 347 obrazložitve izpodbijanega sklepa pa med drugim izhaja, da je imelo podjetje Merck (GUK) v času sklenitve sporazuma GUK za EGP namen in sposobnost tržiti citalopram v EGP v dovolj kratkem roku za vršenje konkurenčnega pritiska na družbo Lundbeck. | 233 | In addition, that argument once again disregards the distinction between actual and potential competition; the latter does not require the demonstration of certain market entry, but merely the existence of real concrete possibilities in that respect. It can be seen from recitals 328 and 347 of the contested decision, inter alia, that Merck (GUK) had the intention and capacity to sell citalopram in the EEA within a sufficiently short period to exert competitive pressure on Lundbeck, at the time the GUK EEA agreement was concluded. |
| 234 | Vsekakor pa iz izpodbijanega sklepa izhaja, da je Komisija upoštevala razlike med državami EGP, če so se izkazale za upoštevne pri analizi obstoja potencialne konkurence na tem ozemlju. Tako je Komisija v točki 327 obrazložitve izpodbijanega sklepa med drugim navedla, da je patent za AFU družbe Lundbeck v Avstriji – drugače kot v drugih državah članicah – potekel šele aprila 2003. V točkah 326, 347 ter od 827 do 830 obrazložitve izpodbijanega sklepa je analizirala tudi položaj v zvezi z DZP v različnih državah EGP. | 234 | In any event, it can be seen from the contested decision that the Commission took into account the differences between the EEA Member States when those differences were relevant for the purpose of examining the existence of potential competition in that territory. Thus, the Commission mentioned, in recital 827 of the contested decision, inter alia, that Lundbeck’s API patent expired only in April 2003 in Austria, unlike in the other Member States. It also examined the situation as regards the MAs in various EEA States in recitals 326, 347 and 827 to 830 of the contested decision. |
| 235 | V zvezi s trditvijo tožečih strank, da bi družba NM Pharma zagotovo naletela na oviro sodnih postopkov, ki bi jih tožeči stranki sprožili, zadostuje ugotovitev, da ta trditev ni v skladu z dejanskim stanjem, saj je družba NM Pharma za skoraj pet mesecev dejansko vstopila na švedski trg in tam dosegla „zelo spodbudno“ prodajo (točka 325 obrazložitve izpodbijanega sklepa), ne da bi družba Lundbeck zoper njo sprožila kakršen koli sodni postopek. | 235 | As regards the applicants’ argument that NM Pharma would have inevitably faced litigation brought by the applicants, it suffices to note that that assertion is not supported by the facts, since NM Pharma actually entered the Swedish market for almost five months, making ‘very encouraging’ sales (recital 325 of the contested decision), without facing any litigation from Lundbeck. |
| 236 | Zato je treba šesti del zavrniti. | 236 | The sixth part must therefore be rejected. |
| I – Sedmi del: neobstoj potencialne konkurence med družbo Lundbeck in podjetjem Arrow v času sklenitve spornih sporazumov | I – The seventh part, alleging the absence of potential competition between Lundbeck and Arrow at the time the agreements at issue were concluded |
| 237 | Tožeči stranki trdita, da podjetje Arrow v času sklenitve sporazuma Arrow UK in danskega sporazuma Arrow ni bilo njun potencialni konkurent. | 237 | The applicants maintain that at the time of the conclusion of the Arrow UK and Arrow Danish agreements, Arrow was not in a situation in which there was potential competition between it and the applicants. |
| 238 | Prvič, kar zadeva Združeno kraljestvo naj bi namreč podjetje Arrow DZP pridobilo šele julija 2002, to pa naj bi se poleg tega nanašalo na AFU družb Cipla in Matrix, pridobljenih po njunih izvirnih proizvodnih postopkih, to je postopkih Cipla I in Matrix I, s katerima se je po njunem mnenju kršil patent za kristalizacijo. Nobenega dokaza naj ne bi bilo, da je imelo podjetje Arrow razumne možnosti za dosego razveljavitve tega patenta. Sicer pa naj ne bi moglo pričakovati pomoči družbe Cipla pri dokazovanju neobstoja kršitve. | 238 | As regards the United Kingdom, the applicants argue, first, that Arrow did not have an MA until July 2002, and, moreover, that MA related to the APIs of Cipla and Matrix, obtained using their original production processes, the Cipla I process and the Matrix I process, which, according to them, infringed the crystallisation patent. There is no proof that Arrow had a reasonable prospect of having that patent declared invalid. Furthermore, Arrow could not rely on Cipla’s cooperation to prove that there was no infringement. |
| 239 | Drugič, podjetje Arrow naj ne bi imelo niti dejanskih niti konkretnih možnosti za zamenjavo s proizvodi AFU na podlagi postopkov Cipla II in Matrix II, ki pa so bili tudi ponarejeni, ali s citalopramom podjetja Ranbaxy, ki poleg tega, da sta se z njim kršila patenta za amid in jod, ni bil zajet z nobenim DZP. | 239 | Nor, secondly, did Arrow have real concrete possibilities of switching to APIs produced using the Cipla II and Matrix II processes, which in any event were also infringing, or to Ranbaxy’s citalopram, which, in addition to infringing the amide and iodo patents, was not covered by an MA. |
| 240 | Tretjič, tožeči stranki se sklicujeta na sodbo English High Court z dne 23. oktobra 2001 v zadevi Smithkline Beecham Plc v. Generics (UK) Ltd (2002) 25(1) I.P.D. 25005 (v nadaljevanju: sodba Paroksetin), iz katere naj bi izhajalo, da generično podjetje ne more vstopiti na trg dokler ne dokaže, da njegov proizvod ne pomeni nikakršne kršitve, česar pa naj podjetje Arrow ne bi moglo storiti. | 240 | Thirdly, the applicants invoke the judgment of the High Court of England and Wales, Chancery Division, of 23 October 2001 in Smithkline Beecham Plc v Generics (UK) Ltd ([2002] 25(1) I.P.D. 25005; ‘the Paroxetine judgment’), from which it follows, according to them, that a generic undertaking cannot enter the market before it has proved that its product does not constitute an infringement, which Arrow was unable to do. |
| 241 | Četrtič, to da sta tožeči stranki privolili v sklenitev sporazumov s podjetjem Arrow, po katerih sta bili zavezani k plačilu podjetju Arrow, naj ne bi pomenilo, da sta ga dojemali kot potencialnega konkurenta, ampak da ju je skrbela kršitev njunih patentov. | 241 | Fourthly, the fact that the applicants agreed to conclude agreements with Arrow under which they were required to make payments to Arrow does not mean that they perceived Arrow as a potential competitor, but that they feared that it would infringe their patents. |
| 242 | V zvezi z Dansko se tožeči stranki večinoma sklicujeta na utemeljitve v zvezi z Združenim kraljestvom, dodajata pa, da je podjetje Arrow vstopilo na danski trg šele leta 2005, in da so bile med trajanjem danskega sporazuma Arrow zoper več generičnih podjetij izdane začasne odredbe, ko so poskušala prodajati generični citalopram v tej državi članici. | 242 | As regards Denmark, the applicants refer to most of the arguments raised in respect of the United Kingdom, while adding that Arrow entered the Danish market only in 2005 and that during the term of the Arrow Danish agreement a number of generic undertakings were the subject of injunctions when they attempted to sell generic citalopram in that Member State. |
| 243 | Komisija zavrača vse te trditve. | 243 | The Commission contests all those arguments. |
| 1. Položaj v Združenem kraljestvu | 1. The situation in the United Kingdom |
| 244 | Na prvem mestu je treba analizirati trditve tožečih strank v zvezi z domnevnim neobstojem potencialne konkurence med njima in podjetjem Arrow v času sklenitve sporazuma Arrow UK. | 244 | It is appropriate to examine, in the first place, the applicants’ arguments concerning the alleged lack of potential competition between them and Arrow at the time the Arrow UK agreement was concluded. |
| 245 | V zvezi s trditvami tožečih strank glede domnevne nezmožnosti podjetja Arrow za vstop na trg s citalopramom družb Cipla ali Matrix, je treba navesti te ugotovitve. | 245 | As regards the applicants’ arguments relating to the alleged impossibility for Arrow to enter the market with the Cipla citalopram or the Matrix citalopram, it is necessary to note the following. |
| 246 | Prvič, Komisija je v točkah 375 in 878 obrazložitve izpodbijanega sklepa ugotovila, da je podjetje Arrow 22. maja 2001 sklenilo sporazum z družbo Tiefenbacher, da bo na eni strani kupilo DZP, za katera je zadnjenavedena v zvezi z generičnim citalopramom zaprosila v več državah EGP, na drugi pa tablete tega zdravila, proizvedene iz AFU družb Cipla ali Matrix. | 246 | First, in recitals 375 and 878 of the contested decision, the Commission found that, on 22 May 2001, Arrow had concluded an agreement with Tiefenbacher in order to purchase, on the one hand, the MAs that Tiefenbacher had requested in several EEA countries concerning generic citalopram and, on the other hand, tablets of that medicinal product produced using the Cipla or Matrix API. |
| 247 | Drugič, Komisija je v točkah 379 in 878 obrazložitve izpodbijanega sklepa ugotovila, da je podjetje Arrow 10. septembra 2001 pri družbi Tiefenbacher naročilo za 2,8 milijona nemških mark (DEM) tablet generičnega citaloprama, ki jih je deloma prejelo novembra 2001, deloma pa drugi teden januarja 2002. Te tablete so bile razvite iz AFU družbe Cipla po postopku Cipla I. | 247 | Secondly, in recitals 379 and 878 of the contested decision, the Commission noted that, on 10 September 2001, Arrow had ordered 2.8 million German marks (DM) worth of citalopram tablets from Tiefenbacher, which it received in part in November 2001 and in part during the second week of January 2002. Those tablets had been developed using the Cipla API, produced in accordance with the Cipla I process. |
| 248 | Tretjič, iz točke 382 obrazložitve izpodbijanega sklepa izhaja, da je 14. decembra 2001 potekal sestanek med tožečima strankama in družbo Tiefenbacher. Iz zabeležke tega sestanka, ki sta ga tožeči stranki predložili Splošnemu sodišču, je razvidno mnenje družbe Tiefenbacher, da bi se s citalopramom, proizvedenim po postopku Cipla I, lahko kršil patent za kristalizacijo, če bi bil podeljen v Združenem kraljestvu, čeprav je družba Cipla trdila, da njen postopek ustreza tistim, na katere se nanašajo izvirni patenti. Iz navedene zabeležke je razvidno tudi, da je podjetje Arrow želelo pripraviti obrambno strategijo zoper predloge za izdajo začasnih odredb, ki bi jih družba Lundbeck vložila pri pristojnih sodiščih zaradi nasprotovanja njegovemu vstopu na trg Združenega kraljestva. Poleg tega je v elektronskem sporočilu, s katerim je bila poslana navedena zabeležka, omenjeno da je sodelavec podjetja Arrow analiziral postopka Cipla I in Matrix I ter ugotovil, da se zdi, da se z njima ne krši patent za kristalizacijo. | 248 | Thirdly, it can be seen from recital 382 of the contested decision that, on 14 December 2001, a meeting was held between Arrow and Tiefenbacher. According to the notes on that meeting, which the applicants produced before the Court, Tiefenbacher considered that the citalopram produced in accordance with the Cipla I process could infringe the crystallisation patent, if it was granted in the United Kingdom, although Cipla argued that its process was one of those referred to in the original patents. Those notes also show that Arrow wanted to prepare a defence strategy as regards the applications for injunctions that Lundbeck was going to make before the competent courts in order to oppose Arrow’s entry to the United Kingdom market. In addition, the email accompanying those notes mentions the fact that an Arrow employee had examined the Cipla I and Matrix I processes and had concluded that they did not seem to infringe the crystallisation patent. |
| 249 | Četrtič, v skladu s točko 383 obrazložitve izpodbijanega sklepa je podjetje Arrow 21. decembra 2001 od družbe Tiefenbacher odkupilo vlogo za DZP, ki jo je ta predhodno vložila pri pristojnih organih Združenega kraljestva. Tej vlogi, ki je v skladu s postopkom medsebojnega priznavanja iz člena 18 Direktive 2001/83 temeljila na DZP, ki ga je družba Tiefenbacher predhodno pridobila na Nizozemskem, je bilo ugodeno julija 2002, potem ko ni uspela tožba družbe Lundbeck zoper zadnjenavedeno DZP na Nizozemskem. V zvezi s tem je treba ugotoviti – kot je Komisija izpostavila v točki 882 obrazložitve izpodbijanega sklepa – da se potencialna konkurenca začne pred izdajo DZP (točke od 92 do 94 zgoraj) in da je bilo DZP izdano med trajanjem sporazuma Arrow UK. | 249 | Fourthly, according to recital 383 of the contested decision, on 21 December 2001, Arrow purchased from Tiefenbacher the MA application that Tiefenbacher had previously lodged with the competent authorities in the United Kingdom. That application, which was based, in accordance with the mutual recognition procedure referred to in Article 18 of Directive 2001/83, on the MA that Tiefenbacher had already obtained in the Netherlands, was granted in July 2002, after the action that Lundbeck had brought in the Netherlands against that MA had failed. In that respect, it must be noted that, as the Commission mentioned in recital 882 of the contested decision, potential competition begins before the issue of an MA (paragraphs 92 to 94 above) and that, in any event, that MA was issued during the term of the Arrow UK agreement. |
| 250 | Petič, Komisija je v točki 387 obrazložitve izpodbijanega sklepa izpostavila, da je družba Cipla v elektronskem sporočilu, poslanem podjetju Arrow 15. januarja 2002, izrazila pripravljenost, da ga podpre v okviru morebitnega sodnega spora z družbo Lundbeck, čeprav je želela posredovati potrebne informacije v zvezi s svojim postopkom neposredno pristojnim organom in ne najprej tožečima strankama ali družbi Tiefenbacher. Zato je brezpredmetno, da družba Cipla v skladu z elektronskim sporočilom z dne 11. januarja 2002, navedenem v točki 385 obrazložitve izpodbijanega sklepa, ni želela dati več informacij o svojem postopku. | 250 | Fifthly, in recital 387 of the contested decision, the Commission emphasised the fact that, in an email sent to Arrow on 15 January 2002, Cipla stated that it was ready to support Arrow in any litigation with Lundbeck, although it wished to provide the necessary information concerning its process directly to the competent authorities, and not first to Arrow or to Tiefenbacher. Thus, it is irrelevant that, according to an email of 11 January 2002, mentioned in recital 385 of the contested decision, Cipla did not wish to provide further information on its process. |
| 251 | Šestič, iz točke 389 obrazložitve izpodbijanega sklepa izhaja, da je podjetje Arrow v elektronskem sporočilu z dne 22. januarja 2002 v odgovor na opozorilo tožečih strank, ki sta mu ga poslali dan prej, zadnjenavedeni obvestilo o svojem stališču, da ne krši njunih novih patentov. | 251 | Sixthly, it can be seen from recital 389 of the contested decision that, in an email of 22 January 2002, in response to a warning received from the applicants the day before, Arrow informed the applicants that it did not believe that it was infringing their new patents. |
| 252 | Sedmič, hčerinska družba podjetja Arrow, družba Resolution Chemicals, je v elektronskem sporočilu z dne 23. januarja 2002, omenjenem v točkah 390, 880 in 887 obrazložitve izpodbijanega sklepa in naslovljenem na nekega proizvajalca AFU citalopram, navedla, da bo „v Združenem kraljestvu začela [tržiti svoj proizvod] naslednji teden“. Družba Resolution Chemicals je v tem elektronskem sporočilu izrazila tudi interes za AFU tega proizvajalca kot drugi vir AFU. | 252 | Seventhly, in an email of 23 January 2002, cited in recitals 390, 880 and 887 of the contested decision and sent to another producer of the citalopram API, a subsidiary of Arrow, Resolution Chemicals stated that it would ‘launch [its product] in [the] UK [the following] week’. In that email, Resolution Chemicals also expressed an interest in the API of that supplier, as a second API source. |
| 253 | Osmič, opozoriti je treba na to, da podjetje Arrow v sedmi uvodni izjavi preambule sporazuma Arrow UK ni priznalo, da je kršilo nove patente družbe Lundbeck, ampak je navedlo samo to, da te obtožbe ne more ovreči z neizpodbitnimi dokazi. | 253 | Eighthly, it must be recalled that, in the seventh recital in the Arrow UK preamble, Arrow did not state that it had infringed Lundbeck’s new patents, but merely observed that it could not disprove that accusation by ‘any demonstrable inconvertible’ evidence. |
| 254 | Devetič, zlasti iz točk 157, 627, 669 in 745 obrazložitve ter opombe 322 izpodbijanega sklepa izhaja, da so tudi druga generična podjetja in družba Lundbeck dvomili v veljavnost patenta za kristalizacijo. Natančneje, zadnjenavedena je menila, da je verjetnost razveljavitve tega patenta od 50‑ do 60‑odstotna. Res je, da dokazi v zvezi s to oceno izvirajo iz časa po sklenitvi spornih sporazumov. Vendar tožeči stranki nista predložili nobenega dokaza, s katerim bi bilo mogoče pojasniti, kako bi bila njuna presoja tega vprašanja pred tem drugačna. Sicer pa je treba upoštevati tudi preudarke iz točke 122 zgoraj glede razveljavitve patentiranih postopkov. Če bi bil namreč patent za kristalizacijo razveljavljen, bi bilo to, da bi podjetje Arrow morebiti kršilo ta patent, brez posledic. | 254 | Ninthly, it can be seen inter alia from recitals 157, 627, 669 and 745 and footnote No 322 of the contested decision that the other generic undertakings and even Lundbeck itself had doubts regarding the validity of the crystallisation patent. In particular, Lundbeck estimated the probability that that patent would be invalidated at 50 to 60%. It is true that the evidence concerning that estimation dates from the period after the conclusion of the agreements at issue. However, the applicants have not provided any evidence capable of explaining how, hitherto, their assessment of that question would have been different. Furthermore, account must also be taken of the considerations set out in paragraph 122 above concerning the invalidation of the process patents. If the crystallisation patent had been declared invalid, any violation of that patent by Arrow would have been without consequences. |
| 255 | Ti dokazi zadostujejo za ugotovitev, da je bilo podjetje Arrow ob sklenitvi sporazuma Arrow UK potencialni konkurent družbi Lundbeck, ker je imelo dejanske in konkretne možnosti za vstop za trg s citalopramom družbe Cipla, proizvedenim po postopku Cipla I. | 255 | Those pieces of evidence are sufficient to support a finding that, when the Arrow UK agreement was concluded, Arrow was in a situation of potential competition with Lundbeck as a result of Arrow’s real concrete possibilities of entering the market with the Cipla citalopram, produced in accordance with the Cipla I process. |
| 256 | V zvezi z možnostjo podjetja Arrow, da zamenja proizvajalca AFU in začne uporabljati AFU družbe Matrix, proizvedeno po postopku Matrix I, ki bi ji jo lahko dobavila družba Tiefenbacher, je treba ugotoviti, da je podjetje Arrow v spremnem elektronskem sporočilu k zabeležki sestanka z dne 14. decembra 2001 (glej točko 248 zgoraj) menilo, da se s postopkom, ki ga družba Matrix uporablja za proizvodnjo AFU, verjetno ne krši patent za kristalizacijo. V tej zabeležki je omenjana tudi možnost, da bi podjetje Arrow prešlo na AFU družbe Matrix, ob domnevi, da take spremembe ne bi bilo mogoče izvesti v takratni fazi. V zvezi s tem je treba ugotoviti – kot je Komisija utemeljeno ugotovila v točkah 885, 886, 889 in 895 obrazložitve ter opombi 1636 izpodbijanega sklepa – da je sporazum podjetja Arrow z družbo Tiefenbacher tako zamenjavo dopuščal, in čeprav je bila morda taka možnost za podjetje Arrow manj ugodna kot sklenitev sporazuma z družbo Lundbeck, pa ne onemogoča sklepa, da je imelo dejansko in konkretno možnost vstopiti na trg s citalopramom, proizvedenim iz te AFU. | 256 | As regards the possibility for Arrow to switch API producer and use the Matrix API, produced in accordance with the Matrix I process, which Tiefenbacher could have provided to it, it must be observed that, according to the email accompanying the notes on the meeting of 14 December 2001 (see paragraph 248 above), Arrow believed that the process used by Matrix to produce that API probably did not infringe the crystallisation patent. Those notes also mention the possibility for Arrow to switch to the Matrix API, while presuming that it would not be possible to make such a switch at that stage. In that respect, it must be noted, as the Commission rightly observes in recitals 885, 886, 889 and 895 and in footnote No 1636 of the contested decision, that Arrow’s agreement with Tiefenbacher allowed such a switch, so the fact that that option may have been a less advantageous solution for Arrow than concluding an agreement with Lundbeck does not alter the conclusion that Arrow had a real concrete possibility of entering the market with the citalopram produced on the basis of that API. |
| 257 | V zvezi s trditvami tožečih strank glede postopkov Matrix II in Cipla II je treba napotiti na točki 198 in 200 zgoraj. | 257 | As regards the applicants’ argument concerning the Matrix II and Cipla II processes, reference should be made to paragraphs 198 to 200 above). |
| 258 | V zvezi z utemeljitvijo tožečih strank na podlagi sodbe Paroksetin je treba spomniti, da je vprašanje razlage nacionalnega prava države članice dejansko vprašanje (glej sodbi z dne 21. decembra 2011, A2A/Komisija, C‑318/09 P, EU:C:2011:856, točka 125 in navedena sodna praksa, in z dne 16. julija 2014, Zweckverband Tierkörperbeseitigung/Komisija, T‑309/12, EU:T:2014:676, točka 222 in navedena sodna praksa), v zvezi s katerim mora Splošno sodišče načeloma opraviti popolni nadzor (točka 113 zgoraj). | 258 | As regards the applicants’ argument based on the Paroxetine judgment, cited in paragraph 240 above, it must be borne in mind that a question relating to the interpretation of the national law of a Member State is a question of fact (see, to that effect and by analogy, judgments of 21 December 2011 in A2A v Commission, C‑318/09 P, EU:C:2011:856, paragraph 125 and the case-law cited, and of 16 July 2014 in Zweckverband Tierkörperbeseitigung v Commission, T‑309/12, EU:T:2014:676, paragraph 222 and the case-law cited) in respect of which the General Court is required, in principle, to carry out a comprehensive review (paragraph 113 above). |
| 259 | Zadevno sodišče je v zadevi, v kateri je bila izdana zgoraj v točki 240 navedena sodba Paroksetin, uporabilo načela, ki urejajo izdajanje začasnih odredb v angleškem pravu, in ocenilo, da se je tehtanje interesov nagnilo v korist proizvajalca originalnih zdravil zaradi posebnosti zadeve in še posebej dejstva, da zadevno generično podjetje ni „sprostilo poti“ s seznanitvijo navedenega proizvajalca originalnih zdravil o svoji trdni nameri, da svoj generični proizvod da na trg, čeprav se je na ta vstop pripravljalo štiri leta in kljub zavedanju, da ima prvonavedeno podjetje patent, ki mu omogoča vložitev tožbe zoper njega zaradi kršitev. | 259 | In the case that gave rise to the Paroxetine judgment, cited in paragraph 240 above, the court concerned applied the principles governing the grant of interim injunctions in English law and found that the balance of interests weighed in favour of the originator undertaking in view of the particular circumstances of the case and in particular the fact that the generic undertaking in question had not ‘cleared the way’ by informing the originator undertaking of its firm intention to launch its generic product on the market, even though it had been preparing for that entry for four years and despite the fact that it knew that the originator undertaking held patents allowing it to bring an infringement action against the generic undertaking. |
| 260 | Ne glede na to pa je treba ugotoviti – ne da bi se bilo treba izreči o razlagi in natančnem obsegu navedene sodbe – da obstaja več razlik med obravnavano zadevo in tisto, v kateri je bila izdana navedena sodba. | 260 | Nevertheless, without it being necessary to rule on the interpretation and the exact scope to be given to the Paroxetine judgment, cited in paragraph 240 above, it must be noted that there are several differences between the present case and the case which gave rise to that judgment. |
| 261 | Na eni strani namreč iz točke 374 obrazložitve izpodbijanega sklepa izhaja, da sta bili tožeči stranki in podjetje Arrow v stiku že 15. decembra 2000 zaradi pogovora o vprašanju generičnega citaloprama. Poleg tega je Komisija v točki 389 obrazložitve izpodbijanega sklepa ugotovila, da je podjetje Arrow januarja 2002 tožečima strankama potrdilo, da se pripravlja na vstop na trg Združenega kraljestva. | 261 | First, it can be seen from recital 374 of the contested decision that the applicants and Arrow had already been in contact on 15 December 2000 in order to discuss the issue of generic citalopram. In addition, in recital 389 of the contested decision, the Commission noted that, in January 2002, Arrow had confirmed to the applicants that it was preparing to enter the market in the United Kingdom. |
| 262 | Na drugi strani, medtem ko je v zadevi, v kateri je bila izdana zgoraj v točki 240 navedena sodba Paroksetin, patent, ki ga je domnevno kršilo zadevno generično podjetje, obstajal že ves čas, v katerem se je to pripravljalo na vstop na trg, pa je bila v obravnavani zadevi prijava patenta za kristalizacijo družbe Lundbeck v Združenem kraljestvu vložena šele 12. marca 2001, objavljena pa šele 4. julija 2001, patent pa je bil v smislu člena 25 UK Patents Act dokončno odobren šele 30. januarja 2002, torej po sklenitvi sporazuma Arrow UK. | 262 | In addition, whereas in the case that gave rise to the Paroxetine judgment, cited in paragraph 240 above, the patent allegedly infringed by the generic undertaking in question already existed throughout the period in which that undertaking was preparing to enter the market, in the present case, Lundbeck filed its application for the crystallisation patent in the United Kingdom only on 12 March 2001 and that application was not published until 4 July 2001, the patent itself being definitively issued, for the purpose of Article 25 of the UK Patents Act, only on 30 January 2002, after the Arrow UK agreement had been concluded. |
| 263 | Poleg tega tožeči stranki, razen nepopolnosti sistema varstva patentov v Evropi in iz tega izhajajoče asimetrije tveganj, nista pojasnili razlogov, iz katerih se je njuno podjetje, ki je izkušeno in mu svetujejo specializirani odvetniki, odločilo za sklenitev dragega sporazuma kot je sporazum Arrow UK, ki mu je omogočil zgolj odlog vstopa podjetja Arrow na trg v Združenem kraljestvu. Čeprav bi bila namreč njuna razlaga zgoraj v točki 240 navedene sodbe Paroksetin pravilna, tako kot njuno prepričanje, da lahko preprečita vstop generikov z uveljavljanjem njunih patentov, bi bili zoper podjetje Arrow v Združenem kraljestvu zagotovo odrejeni začasni ukrepi ob poskusu vstopa na ta trg z njenimi generičnimi zdravili, s čimer bi preprečili ta vstop v pričakovanju ugodne sodbe o vsebini. | 263 | Furthermore, the applicants have given no explanation, other than the imperfect nature of the patents system in Europe and the resulting asymmetry of risk, as to why the undertaking of which they form part — which is an experienced undertaking, advised by specialist lawyers — preferred to conclude a costly agreement such as the Arrow UK agreement, which merely allowed it delay Arrow’s entry to the United Kingdom market. If their interpretation of the Paroxetine judgment, cited in paragraph 240 above, and their belief that they would be able to block the entry of generics by enforcing their patents, were correct, interim measures would surely have been granted against Arrow in the United Kingdom if Arrow attempted to enter that market with its generic medicinal products, thus allowing them to block that entry pending a favourable judgment on the substance. |
| 264 | V delu, v katerem se tožeči stranki v bistvu sklicujeta na asimetrijo tveganja med njima in podjetjem Arrow, je treba ugotoviti, da samo s tako utemeljitvijo ni mogoče ovreči ugotovitve, da sta podjetje Arrow v času sklenitve sporazuma Arrow UK dojemali kot grožnjo na trgu citaloprama. | 264 | In so far as the applicants invoke, in essence, the asymmetry of risks between themselves and Arrow, it must be noted that such an argument is not capable, by itself, of calling into question the conclusion that they perceived Arrow as a threat on the citalopram market at the time the Arrow UK agreement was concluded. |
| 265 | V zvezi s trditvami tožečih strank, da podjetja Arrow nista dojemali kot potencialnega konkurenta, ampak kot podjetje, ki potencialno krši njune patente, je treba ugotoviti, da je zgolj dejstvo, da sta s podjetjem Arrow sklenili sporazum, močan indic za to, da sta zadnjenavedeno podjetje dojemali kot potencialnega konkurenta (glej točko 181 zgoraj). Poleg tega je treba spomniti, da se podjetje Arrow ni strinjalo s stališčem družbe Lundbeck, da so bili njeni patenti kršeni (glej sedmo uvodno izjavo preambule sporazuma Arrow UK, točka 35 zgoraj), česar v času sklenitve sporazuma Arrow UK ni potrdilo nobeno sodišče. | 265 | As regards the applicants’ arguments relating to the fact that they did not perceive Arrow as a potential competitor but rather as an undertaking that might infringe their patents, it must be pointed out that the very fact that they concluded an agreement with Arrow is a very strong indication that they perceived Arrow as a potential competitor (see paragraph 181 above). In addition, it must be borne in mind that Lundbeck’s belief that its patents had been infringed was not shared by Arrow (see the seventh recital in the preamble to the Arrow UK agreement and paragraph 35 above) and had not been confirmed by any court at the time the Arrow UK agreement was concluded. |
| 266 | Zato je treba skleniti, da Komisija ni storila napake pri presoji, ko je podjetje Arrow v izpodbijanem sklepu obravnavala kot potencialnega konkurenta družbe Lundbeck v Združenem kraljestvu. | 266 | Accordingly, it must be concluded that the Commission did not commit any error of assessment in treating Arrow as a potential competitor of Lundbeck in the United Kingdom in the contested decision. |
| 2. Položaj na Danskem | 2. The situation in Denmark |
| 267 | Na drugem mestu, v zvezi s potencialno konkurenco na Danskem je treba, prvič, zavrniti trditev tožečih strank, da podjetje Arrow ni vstopilo na trg ob poteku danskega sporazuma Arrow aprila leta 2003, pač pa šele leta 2005. V zvezi s tem je treba najprej ugotoviti, da gre za dokaz za nazaj in da se nanaša na dejansko in ne potencialno konkurenco. Poleg tega je treba ugotoviti, da položaj po poteku navedenega sporazuma ni bil primerljiv s tistim pred tem, ker so se medtem spremenile tržne razmere. | 267 | In the second place, as regards the potential competition in Denmark, it is appropriate first to reject the applicants’ argument concerning the fact that Arrow did not enter the market upon the expiry of the Arrow Danish agreement, in April 2003, but only in 2005. In that respect, it must be pointed out, first of all, that that argument concerns ex post evidence and that it relates to actual competition, and not potential competition. Moreover, it must be noted that the situation which existed after the expiry of that agreement was not comparable to that which preceded it, since the conditions on that market had changed in the meantime. |
| 268 | Drugič, v zvezi z dejstvom, da sta tožeči stranki dosegli več začasnih odredb na Danskem, je treba ugotoviti, da so te poznejše od sklenitve danskega sporazuma Arrow, čeprav se Komisiji ni bilo treba opirati nanje pri presoji, ali so bile v času sklenitve navedenega sporazuma možnosti podjetja Arrow za vstop na trg dejanske in konkretne. Tudi če bi bilo mogoče te začasne odredbe upoštevati, pa bi bilo treba upoštevati tudi odločitve po pritožbah, na podlagi katerih je bilo več na prvi stopnji doseženih začasnih odredb razveljavljenih, kar je Komisija ugotovila v točki 185 obrazložitve izpodbijanega sklepa. | 268 | Secondly, as regards the fact that the applicants obtained several injunctions in Denmark, it must be pointed out that those injunctions were granted after the Arrow Danish agreement had been concluded, with the result that the Commission was not required to take them into account in evaluating whether Arrow had real concrete possibilities of entering the market at the time that agreement was concluded. Even if those injunctions could be taken into account, that would also be the case for the decisions on appeal which withdrew several injunctions granted at first instance, as the Commission observed at recital 185 of the contested decision. |
| 269 | Tretjič, podjetje Arrow je resda ob sklenitvi danskega sporazuma Arrow vedelo, da je postopek Cipla I verjetno ponarejen, vendar bi lahko na eni strani poskušalo doseči razveljavitev patenta za kristalizacijo, na drugi pa si poskušalo najprej priskrbeti citalopram družbe Matrix, proizveden po postopku Matrix I, in nato citalopram, proizveden po postopkih Cipla II ali Matrix II, ali celo tistega podjetja Ranbaxy (glej točke od 198 do 201 in 256 zgoraj). V zvezi s tem je treba ugotoviti, da je podjetje Arrow celo po tem, ko je družba Lundbeck pridobila patent za kristalizacijo na Danskem, nadaljevalo s prizadevanjem za pridobitev DZP v razumnem roku, da bi lahko na danskem trgu prodajalo generični citalopram, ki ga je dobavila družba Tiefenbacher in je bil proizveden iz AFU družbe Cipla ali Matrix (glej točke 450, 454, 967 in 968 obrazložitve izpodbijanega sklepa ter tretjo uvodno izjavo preambule danskega sporazuma Arrow). | 269 | Thirdly, while it is true that, when the Arrow Danish agreement was concluded, Arrow knew that the Cipla I process was probably infringing, it is nevertheless the case that it could have sought to have the crystallisation patent declared invalid and, moreover, that it could have sought to obtain first the Matrix citalopram, produced in accordance with the Matrix I process, and then the citalopram produced in accordance with the Cipla II or Matrix II processes or even that of Ranbaxy (see paragraphs 198 to 201 and 256 above). In that respect, it must be noted that, even after Lundbeck had obtained the crystallisation patent in Denmark, Arrow continued to take steps to obtain an MA within a reasonable period, in order to be able to sell generic citalopram supplied by Tiefenbacher, produced using the Cipla API or the Matrix API, on the Danish market (see recitals 450, 454, 967 and 968 of the contested decision as well as the third recital in the preamble to the Arrow Danish agreement). |
| 270 | Iz tega sledi, da je Komisija utemeljeno presodila, da je bilo podjetje Arrow tudi na Danskem potencialni konkurent družbe Lundbeck. | 270 | It follows that the Commission rightly considered that Arrow was also a potential competitor of Lundbeck in Denmark. |
| 271 | Sedmi del je zato treba zavrniti. | 271 | Consequently, the seventh part of the plea must be rejected. |
| J – Osmi del: neobstoj potencialne konkurence med družbo Lundbeck in podjetjem Alpharma v času sklenitve spornih sporazumov | J – The eighth part, alleging the absence of potential competition between Lundbeck and Alpharma at the time the agreements at issue were concluded |
| 272 | Tožeči stranki trdita, da podjetje Alpharma ob sklenitvi sporazuma Alpharma ni bilo njun potencialni konkurent. | 272 | The applicants maintain that, at the time of the conclusion of the Alpharma agreement, Alpharma was not a potential competitor of the applicants. |
| 273 | Podjetje Alpharma naj namreč, prvič, ne bi imelo dostopa do nobenega citaloprama, s katerim niso bili kršeni njuni patenti, ker je moralo svoje proizvode kupovati pri družbi Tiefenbacher. Zadnjenavedena pa naj bi podjetju Alpharma dobavljala generični citalopram, proizveden po postopku Cipla I, ki je bil očitno ponarejen, in naj bi mu lahko dobavljala samo druge ponarejene proizvode, proizvedene po postopku Matrix I ali, pozneje, po postopkih Cipla II in Matrix II. Poleg tega naj dvomi podjetja Alpharma v zvezi z veljavnostjo patenta za kristalizacijo ne bi pomenili, da je bilo potencialni konkurent, zlasti zato, ker so ti dvomi temeljili na subjektivni presoji. | 273 | They argue, first, that Alpharma did not have access to any citalopram that did not infringe their patents, since it was obliged to buy its products from Tiefenbacher. Tiefenbacher supplied Alpharma with citalopram obtained using the Cipla I process, which was clearly infringing, and could have supplied it only with other infringing products obtained using the Matrix I process or, later, using the Cipla II and Matrix II processes. Furthermore, the fact that Alpharma had doubts as to the validity of the crystallisation patent does not mean that it was a potential competitor, particularly as those doubts were based on subjective assessments. |
| 274 | Drugič, tožeči stranki opozarjata na to, da je podjetje Alpharma imelo DZP samo za osem držav EGP, tudi za Združeno kraljestvo, ki je bilo izdano šele julija 2002. | 274 | Secondly, the applicants observe that Alpharma had an MA for only eight EEA countries, including the MA for the United Kingdom, which was not granted until July 2002. |
| 275 | Komisija te trditve zavrača. | 275 | The Commission disputes those arguments. |
| 276 | V zvezi s tem je treba spomniti, da je Komisija v točki 1035 obrazložitve izpodbijanega sklepa ugotovila, da je podjetje Alpharma v skladu z elektronskim sporočilom z dne 19. februarja 2002 direktorja podjetja Alpharma, zadolženega za konkretno zadevo, namesto sklenitve spornega sporazuma lahko vstopilo na trg s tabletami citaloprama, ki jih je že prejelo ali naročilo in so bile proizvedene po postopku Cipla I, in se sklicevalo na neveljavnost patenta za kristalizacijo, ki je bil s tem postopkom kršen, po informacijah, ki so bile takrat na voljo podjetju Alpharma in družbi Lundbeck. | 276 | In that respect, it must be recalled that, in recital 1035 of the contested decision, the Commission pointed out that, according to an email of 19 February 2002 from the managing director of Alpharma responsible for the dossier in question, instead of concluding the Alpharma agreement, the Alpharma group could have entered the market with the citalopram tablets it had already received or ordered, produced in accordance with the Cipla I process, and could have claimed that the crystallisation patent infringed by that process was invalid, according to the information available to the Alpharma group and Lundbeck at that time. |
| 277 | Na prvem mestu je treba ugotoviti, da tudi iz notranjega elektronskega sporočila z dne 14. februarja 2002 istega direktorja, navedenega v točki 516 obrazložitve izpodbijanega sklepa, izhaja da podjetje Alpharma nikakor ni izključevalo možnosti vstopa na trg s tabletami, ki jih je že prejelo ali naročilo. Avtor navedenega elektronskega sporočila je namreč sodelavcu pojasnil, da je podjetje Alpharma takrat uporabljalo dvojno strategijo („we are riding two horses“), ki je na eni strani zajemala pripravo dajanja citaloprama na trg v več državah EGP, na drugi pa pogajanja z družbo Lundbeck, in da se bo treba naslednji teden verjetno odločiti. V zvezi s tem je navedel, da zaradi sprejeta čim boljše odločitve potrebuje opis pravnega položaja v navedenih državah in tveganj, ki jim je podjetje Alpharma izpostavljeno. | 277 | In the first place, it must be observed that the fact that Alpharma in no way excluded the possibility of entering the market with the tablets that it had already received or ordered can also be seen from the internal email of 14 February 2002, from the same managing director, cited in recital 516 of the contested decision. In that email, the managing director explained to one of his colleagues that, at that time, Alpharma was employing a dual strategy, as shown by the expression ‘we are riding two horses’, consisting, on the one hand, of planning the launch of citalopram in several EEA countries and, on the other hand, of negotiating with Lundbeck, and that, the following week, it would probably be necessary to make a decision. In that respect, he stated that, in order to take the best possible decision, he needed a description of the legal situation in each of those countries and of the risks to which Alpharma was exposed. |
| 278 | Iz elektronskih sporočil z dne 14. in 19. februarja 2002 torej izhaja, da podjetje Alpharma ob zavedanju o tveganjih, ki jih vstop na trg lahko prinese, ni opustilo svojih načrtov, če z družbo Lundbeck ne bi moglo skleniti dovolj ugodnega sporazuma. Ker gre za notranjo elektronsko pošto, ni verjetno, da bi v njej izražena stališča pomenila blefiranje v razmerju do družbe Lundbeck. Poleg tega je bila zadnjenavedena izkušeno podjetje, ki je dolgo časa spremljalo dejavnosti podjetja Alpharma, kot dokazujejo dopisi, omenjeni med drugim v točkah 477 in 496 obrazložitve izpodbijanega sklepa. Ti dopisi so se med drugim sklicevali na uporabni model in patent za kristalizacijo družbe Lundbeck, tako da ni mogoče sklepati, da so v navedenih elektronskih sporočilih izražena stališča brez zavedanja o tveganjih v zvezi s pravicami intelektualne lastnine. | 278 | It therefore follows from the emails of 14 and 19 February 2002 that Alpharma, while aware of the risks that market entry might entail, would not have abandoned its plans if it had not concluded a sufficiently advantageous agreement with Lundbeck. Since those emails were internal, it is not credible that the positions expressed therein were intended to ‘bluff’ Lundbeck. Furthermore, Lundbeck was an experienced undertaking which had for a long time been monitoring the steps taken by Alpharma, as demonstrated, in particular, by the letters mentioned in recitals 477 and 496 of the contested decision. Those letters referred, amongst other things, to Lundbeck’s utility model as well as the crystallisation patent, with the result that it cannot be considered that the positions set out in those internal emails were expressed without knowledge of the risks relating to those intellectual property rights. |
| 279 | Sicer pa je treba spomniti na preudarke iz točk 122 in 254 zgoraj v zvezi z morebitno neveljavnostjo patenta za kristalizacijo. | 279 | Moreover, the considerations set out in paragraphs 122 and 254 above in relation to the potential invalidity of the crystallisation patent must be borne in mind. |
| 280 | Navedbe iz zgoraj navedenih elektronskih sporočil je treba razumeti ob upoštevanju dotedanjih ukrepov podjetja Alpharma za pripravo na vstop na trg. | 280 | The declarations contained in the abovementioned emails must be read in the light of the steps that Alpharma had taken until then in order to prepare for its entry to the market. |
| 281 | V zvezi s tem zlasti iz točk 476, 486, 490, 516 in 1017 obrazložitve izpodbijanega sklepa izhaja, da je podjetje Alpharma v času sklenitve sporazuma Alpharma: | — | imelo z družbo Tiefenbacher že sklenjen sporazum z dne 25. junija 2001 o dobavi generičnega citaloprama, proizvedenega iz AFU družbe Cipla ali Matrix; | — | lahko na podlagi navede pogodbe in predhodne pogodbe med istima strankama z dne 31. julija 2000 pridobilo DZP na Nizozemskem na podlagi tistega, ki ga je družba Tiefenbacher pridobila 31. avgusta 2001 pri organih iste države članice, in je lahko pridobilo DZP v drugih državah članicah EGP na podlagi postopka medsebojnega priznavanja iz Direktive 2001/83; | — | že imelo na zalogi 9,4 milijona tablet citaloprama, naročilo pa jih je še 16 milijonov; | — | že pridobilo DZP na Nizozemskem, Finskem, Danskem in Švedskem, 9. januarja 2002 pa mu je bilo zagotovljeno, da ga bo zelo kmalu pridobilo tudi v Združenem kraljestvu; | — | že objavilo cenik za svoj citalopram v Združenem kraljestvu. | 281 | In that regard, it can be seen, inter alia, from recitals 476, 486, 490, 516 and 1017 of the contested decision that, at the time the Alpharma agreement was concluded, Alpharma: | — | had already concluded a contract with Tiefenbacher, dated 25 June 2001, for the supply of generic citalopram produced using the Cipla API or the Matrix API; | — | could, pursuant to that contract and to a previous contract between the same parties, of 31 July 2000, obtain an MA in the Netherlands, on the basis of the MA issued to Tiefenbacher on 31 August 2001 by the authorities of that Member State, and could, pursuant to the mutual recognition procedure laid down in Directive 2001/83, obtain MAs in other EEA countries; | — | had already a stock of 9.4 million citalopram tablets and had ordered 16 million more; | — | had already obtained MAs in the Netherlands, in Finland, in Denmark and in Sweden and had received, on 9 January 2002, assurances that it would obtain one in the United Kingdom in the very near future; | — | had already published a list of prices for its citalopram in the United Kingdom. |
| 282 | Na drugem mestu je treba ugotoviti – tako kot Komisija v točki 1035 obrazložitve izpodbijanega sklepa – da bi lahko podjetje Alpharma v skladu z elektronskim sporočilom z dne 19. februarja 2002 namesto sklenitve sporazuma Alpharma svoj vstop na trg odložilo do pomladi ali poletja istega leta z zamenjavo za citalopram družbe Matrix, ki je bil v zvezi s patentom za kristalizacijo obravnavan kot neproblematičen. | 282 | In the second place, it must be observed that, as the Commission noted in recital 1035 of the contested decision, according to the email of 19 February 2002, instead of concluding the Alpharma agreement, Alpharma could also have delayed its entry to the market until spring or summer of that year and switched to the Matrix citalopram, which was not considered to be problematic as regards the crystallisation patent. |
| 283 | Res je sicer, da bi v skladu z elektronskim sporočilom z dne 19. februarja 2002 zamenjava za citalopram družbe Matrix povzročila resne nevšečnosti. Vendar je treba ugotoviti, prvič, da je pogodba med družbo Tiefenbacher in podjetjem Alpharma dopuščala zadnjenavedenemu, da pridobi tako citalopram družbe Cipla kot tisti družbe Matrix (glej točko 480 obrazložitve izpodbijanega sklepa). | 283 | It is indeed true that, according to the email of 19 February 2002, the switch to the Matrix citalopram presented serious drawbacks. However, it must be noted, first, that the contract between Tiefenbacher and Alpharma allowed the latter to obtain both the Cipla citalopram and the Matrix citalopram (see recital 480 of the contested decision). |
| 284 | Drugič, čeprav je v elektronskem sporočilu z dne 19. februarja 2002 navedeno, da bi zamenjava za AFU družbe Matrix povzročila odlog vstopa na trg, kar bi zmanjšalo pričakovani donos, pa je treba to pomanjkljivost uravnovesiti s prednostjo zmanjšanja tveganja kršenja patenta za kristalizacijo. Vsekakor pa navedeno elektronsko sporočilo, kljub navedenemu odlogu in njegovimi posledicami, nikakor ne ovrže tega, da je bila zamenjava za AFU družbe Matrix ekonomsko smiselna možnost. Gre samo za dejavnik, zaradi katerega je bilo finančno priporočljivo skleniti ugoden sporazum z družbo Lundbeck. To vprašanje pa ni upoštevno pri presoji, ali so obstajale dejanske in konkretne možnosti za vstop podjetja Alpharma na trg. | 284 | Secondly, although the email of 19 February 2002 states that the switch to the Matrix API would involve market entry being delayed, which would reduce the expected profits, that disadvantage must be weighed against the advantage of reducing the risk of infringement of the crystallisation patent. In any event, that email does not change the fact that, despite that delay and its consequences, the switch to the Matrix API constituted a viable economic option. It was simply a factor making it financially preferable to conclude an advantageous agreement with Lundbeck. That issue is irrelevant to the assessment of whether Alpharma had real concrete possibilities of entering the market. |
| 285 | Tretjič, to da je družba Matrix po sklenitvi sporazuma Alpharma spremenila postopek za proizvodnjo AFU citalopram, kot izhaja iz opombe 155 izpodbijanega sklepa, ne dokazuje, da je bil s prejšnjim postopkom kršen patent za kristalizacijo, ampak samo to, da si je družba Matrix pozneje prizadevala za preprečitev kakršnega koli tveganja kršitve. Poleg tega se je ta sprememba zgodila med trajanjem sporazuma, čeprav bi podjetje Alpharma lahko uporabilo novo AFU družbe Matrix, proizvedeno po postopku Matrix II, če ne bi bilo plačano za to, da je ostalo zunaj trga. Vsekakor pa je podjetje Alpharma 19. februarja 2002 menilo, da bi mu AFU družbe Matrix na podlagi postopka Matrix I, ki ga je takrat uporabljala, omogočila vstop na trg brez kršenja patenta za kristalizacijo. | 285 | Thirdly, the fact that, subsequent to the conclusion of the Alpharma agreement, Matrix altered the process that it used to produce the citalopram API, as can be seen from footnote No 155 of the contested decision, does not demonstrate that the process available hitherto infringed the crystallisation patent, but merely shows the efforts subsequently made by Matrix to avoid all risk of infringement. Moreover, that alteration took place during the term of that agreement, with the result that Alpharma could have used the new Matrix API, produced in accordance with the Matrix II process, if it had not been paid to stay out of the market. In any event, on 19 February 2002, the Alpharma group took the view that the Matrix API, based on the Matrix I process that Matrix used at the time, could allow it to enter the market without infringing the crystallisation patent. |
| 286 | Iz tega sledi, da je imelo podjetje Alpharma ob sklenitvi sporazuma Alpharma dejanske in konkretne možnosti za vstop na trg z generičnim citalopramom, proizvedenim po postopkih Cipla I ali Matrix I. Poleg tega je – kot je bilo analizirano zgoraj v točkah 198 in 200 – med trajanjem navedenega sporazuma postal razpoložljiv tudi generični citalopram, proizveden po postopkih Matrix II in Cipla II. | 286 | It follows that, when the Alpharma agreement was concluded, that undertaking had real concrete possibilities to enter the market with generic citalopram produced in accordance with the Cipla I or Matrix I processes. Moreover, as examined in paragraphs 198 and 200 above, during the term of that agreement, generic citalopram produced in accordance with the Matrix II and Cipla II processes also became available. |
| 287 | Ugotovitev, da je bilo podjetje Alpharma potencialni konkurent tožečih strank, ni ovržena z njunim sklicevanjem na izjavo za javnost podjetja Alpharma z dne 28. februarja 2002. Podjetje Alpharma je v tej izjavi v bistvu najavilo, da prelaga prodajo citaloprama vsaj do konca obdobja poletnih dopustov in da bi lahko po potrebi opustilo to načrtovano prodajo, ker njegova zaloga pomeni težavo glede na patente tožečih strank. Dodalo je, da mora najti drugega proizvajalca AFU in pridobiti potrebna dovoljenja. | 287 | The finding that Alpharma was a potential competitor of the applicants is not called into question by the reference that they make to a press release issued by Alpharma on 28 February 2002. By that press release, Alpharma announced, in essence, that it would postpone the launch of citalopram until at least the end of the summer holiday and that it might, if necessary, abandon that planned launch, on the ground that there was a problem with its stock in view of the applicants’ patents. It added that it had to seek a new API producer and obtain the necessary authorisations. |
| 288 | V zvezi s tem je treba ugotoviti – kot je Komisija ugotovila v točki 1055 obrazložitve izpodbijanega sklepa – da je iz te izjave razvidna sprememba načrtov podjetja Alpharma kot posledica njegove enostranske odločitve. Nikjer namreč ne omenja sporazuma Alpharma, v skladu z njegovo zaupnostjo, kot je določena v njegovem členu 3.1. Poleg tega je treba upoštevati, da se je želelo z navedeno izjavo dati pojasnila potencialnim strankam podjetja Alpharma. | 288 | In that respect, it must be observed that, as the Commission pointed out in recital 1055 of the contested decision, that press release presents the alteration of Alpharma’s plans as result of a unilateral decision of Alpharma. It contains no reference to the Alpharma agreement, in accordance with the confidential nature of that agreement, as laid down in point 3.1 thereof. Moreover, account must be taken of the fact that that press release was intended to provide an explanation to Alpharma’s potential customers. |
| 289 | Zato s to izjavo ni ovržena teza Komisije, ki temelji zlasti na elektronskih sporočilih z dne 14. in 19. februarja 2002 in do tedaj izvedenih ukrepih podjetja Alpharma, po kateri bi imelo to podjetje dejansko in konkretno možnost vstopa na trg, če ne bi sklenilo spornih sporazumov. | 289 | Accordingly, that press release does not undermine the Commission’s thesis — based, inter alia, on the emails of 14 and 19 February 2002 and on the steps that Alpharma had taken until then — that, if Alpharma had not concluded the Alpharma agreement, it would have had a real concrete possibility of entering the market. |
| 290 | V zvezi s trditvijo tožečih strank o tem, da podjetje Alpharma ni imelo DZP v vseh državah EGP zadostuje ugotovitev, da je že imelo več DZP in da je imelo dejanske in konkretne možnosti za pridobitev drugih na podlagi postopka medsebojnega priznavanja iz člena 18 Direktive 2001/83. Poleg tega take možnosti v skladu s preudarki iz točk 162 in 171 zgoraj dejansko pomenijo potencialno konkurenco. | 290 | As regards the applicants’ argument relating to the fact that Alpharma did not have an MA in all the EEA countries, it suffices to note that it already had several MAs and that it had real concrete possibilities of obtaining others through the mutual recognition procedure referred to in Article 18 of Directive 2001/83. Moreover, in view of the considerations set out in paragraphs 163 and 171 above, such possibilities indeed constitute potential competition. |
| 291 | Ob upoštevanju navedenega je treba osmi del zavrniti. | 291 | In the light of the foregoing, the eighth part of the plea must be rejected. |
| K – Deveti del: neobstoj potencialne konkurence med družbo Lundbeck in podjetjem Ranbaxy v času sklenitve spornih sporazumov | K – The ninth part, alleging the absence of potential competition between Lundbeck and Ranbaxy at the time the agreements at issue were concluded |
| 292 | Tožeči stranki trdita, da podjetje Ranbaxy ob sklenitvi sporazuma Ranbaxy ni bilo njun potencialni konkurent. | 292 | The applicants maintain that, at the time the Ranbaxy agreement was concluded, Ranbaxy was not in potential competition with the applicants. |
| 293 | Prvič, tožeči stranki navajata, da ju je podjetje Ranbaxy na sestanku 17. aprila 2002 resda obvestilo, da ima postopek, s katerim se ne krši patent, da predvideva pridobitev DZP v osmih mesecih, in da bo ravnokar sklenilo sporazum z drugim generičnim podjetjem, ki lahko kupi njegovo AFU in vstopi na trg z generičnim citalopramom, proizvedenim iz te AFU, v največ štirih mesecih, vendar je zgolj „blefiralo“, da bi ju prepričalo v sklenitev ugodnega sporazuma za podjetje Ranbaxy. To, da je zadnjenavedeno navajalo podobne razloge kot druga generična podjetja, ki so bila potencialni kupci njegove AFU, naj tudi ne bi imelo dokazne vrednosti. Natančneje, njegova izjava podjetju Alpharma naj bi se zgodila preden je družba Lundbeck proučila reakcijske sheme podjetja Ranbaxy, kar naj bi dokazovalo, da so se s postopkom zadnjenavedenega kršili njuni patenti za amid in jod. | 293 | First, the applicants submit that, although Ranbaxy informed them, at a meeting held on 17 April 2002, that it had a process that did not infringe any patent, that it intended to obtain an MA within eight months and that it was about to enter into an agreement with another generic undertaking which could purchase its API and enter the market with citalopram produced on the basis of that API within no more than four months, it was merely ‘bluffing’ in order to persuade them to enter into an agreement favourable to Ranbaxy. Nor does the fact that Ranbaxy made statements to the same effect to other generic undertakings who were potential buyers of its API have any evidential value. In particular, Ranbaxy’s statement to Alpharma preceded Lundbeck’s examination of Ranbaxy’s reaction schemes, which showed that Ranbaxy’s process infringed the amide and iodo patents. |
| 294 | Drugič, tožeči stranki izpostavljata, da podjetje Ranbaxy ni imelo dejanskih in konkretnih možnosti za pridobitev DZP med trajanjem sporazuma Ranbaxy. Zadnjenavedeno naj bi v upravnem postopku priznalo vse težave v zvezi z medsebojnim priznavanjem iz člena 18 Direktive 2001/83. | 294 | Secondly, the applicants submit that Ranbaxy had no real concrete possibility of obtaining an MA during the term of the Ranbaxy agreement. During the administrative procedure, Ranbaxy acknowledged all the problems associated with the mutual recognition procedure referred to in Article 18 of Directive 2001/83. |
| 295 | Tretjič, tožeči stranki opozarjata na to, da je podjetje Ranbaxy oktobra 2002 izjavilo, da po juniju 2002 ni prodalo nič citaloprama, ne samo v Evropi, ampak po celem svetu, kar naj bi dokazovalo, da tega ni moglo, ne glede na sporazum Ranbaxy, ki se je nanašal samo na EGP. | 295 | Thirdly, the applicants emphasise that, in October 2002, Ranbaxy stated that it had not sold any citalopram after June 2002, not only in Europe but in the entire world, which proves that it could not do so, independently of the Ranbaxy agreement, which related only to the EEA. |
| 296 | Četrtič, tožeči stranki opozarjata na to, da je podjetje Ranbaxy po poteku sporazuma v zvezi z njim od njiju zahtevalo dovoljenje za patent za jod, namesto da bi preprosto uporabljalo svoj postopek, kar naj bi dokazovalo, da se je z njim kršil navedeni patent. | 296 | Fourthly, the applicants observe that after the expiry of the agreement concerning it, Ranbaxy requested them to grant a licence for the iodo patent, instead of simply using its process, which confirms that that process infringed that patent. |
| 297 | Petič, v izpodbijanem sklepu naj ne bi bilo nobenega dokaza za to, da sta tožeči stranki in podjetje Ranbaxy dvomili v veljavnost patentov za amid in jod, ker so navedene izjave zadevale zgolj patent za kristalizacijo. | 297 | Fifthly, the contested decision adduces no evidence that the applicants or Ranbaxy had any doubts as to the validity of the amide and iodo patents, as the statements mentioned relate only to the crystallisation patent. |
| 298 | Komisija te trditve zavrača. | 298 | The Commission disputes those arguments. |
| 299 | Na prvem mestu, v zvezi s trditvami tožečih strank o domnevnem „blefiranju“ podjetja Ranbaxy je treba spomniti, da je Komisija zlasti v točkah 1095 in 1096 obrazložitve izpodbijanega sklepa izpostavila, da iz zapisnika sestanka med njima in podjetjem Ranbaxy z dne 17. aprila 2002 izhaja, da je zadnjenavedeno ob tej priložnosti navedlo, da je: | — | uporabljalo postopek, s katerim se ne kršijo patenti družbe Lundbeck; | — | družba Lundbeck vedela za ta postopek; | — | nameravalo vložiti vlogi za DZP za Združeno kraljestvo in Nemčijo, kjer je imelo svoje hčerinske družbe, in pričakovalo pridobitev teh DZP v osmih mesecih; | — | bilo blizu sklenitvi sporazuma z drugim generičnim podjetjem – ki ga ni imenovalo, vendar je družba Lundbeck menila, da gre za družbo Tiefenbacher ali družbo iz skupine Merck – na podlagi katerega bi svojo AFU pripeljalo na trg severne Evrope v treh ali štirih mesecih; | — | bila njegova svetovna proizvodna zmogljivost 4,5 tone AFU letno; | — | bilo pripravljeno skleniti sporazum z družbo Lundbeck. | 299 | In the first place, as regards the applicants’ argument concerning Ranbaxy’s alleged ‘bluffing’, it must be noted that, as the Commission emphasised, inter alia, in recitals 1095 and 1096 of the contested decision, it can be seen from the minutes of the meeting of 17 April 2002 between them and Ranbaxy, that, on that occasion, the latter had indicated the following: | — | it used a process which did not infringe Lundbeck’s patents; | — | Lundbeck knew of that process; | — | it intended to file MA applications for the United Kingdom and Germany, where it had its own subsidiaries, and it expected to receive those MAs within eight months; | — | it was nearing conclusion of an agreement with another generic undertaking — which it did not identify, but which Lundbeck believed to be Tiefenbacher or a company in the Merck group — on the basis of which it would be able to bring its API to the Northern Europe market within three to four months; | — | its production capacity was 4.5 tonnes of API per year worldwide; | — | it was ready to conclude an agreement with Lundbeck. |
| 300 | Podobno je treba ugotoviti, da je družba Lundbeck v skladu z navedenim zapisnikom vedela, da je lahko tak sporazum drag in težaven, zlasti ob upoštevanju prava konkurence (glej točki 188 in 1095 obrazložitve izpodbijanega sklepa). | 300 | Likewise, it must be pointed out that, according to those minutes, Lundbeck knew that such an agreement could be costly and difficult, in particular from a competition law perspective (see recitals 188 and 1095 of the contested decision). |
| 301 | Družba Lundbeck se je kljub temu odločila skleniti sporazum Ranbaxy, kar dokazuje, da je resno jemala grožnjo, ki jo je pomenilo to podjetje. | 301 | Nevertheless, Lundbeck decided to conclude the Ranbaxy agreement, which shows that it took seriously the threat posed by Ranbaxy. |
| 302 | V tem okviru je treba ugotoviti, da je v skladu s sodno prakso (glej točki 101 in 104 zgoraj) to, kako družba Lundbeck dojema podjetje Ranbaxy, dejavnik, ki se lahko upošteva, čeprav ne zadostuje kot dokaz za obstoj potencialne konkurence. | 302 | In that context, it must be noted that, in accordance with the case-law (see paragraphs 101 and 104 above), the perception that Lundbeck had of Ranbaxy is a factor that may be taken into consideration, although it does not suffice, by itself, to demonstrate the existence of potential competition. |
| 303 | V zvezi z možnostjo, da je na dojemanje tožečih strank vplivalo uspešno „blefiranje“ podjetja Ranbaxy, je treba najprej ugotoviti, da sta biti ti izkušeno podjetje, ki je dolgo spremljalo generična podjetja v zvezi s citalopramom (glej med drugim točke od 172 do 183 obrazložitve izpodbijanega sklepa). | 303 | As regards the possibility that the applicants’ perception was affected by ‘bluffing’ on Ranbaxy’s part, it must be noted, first of all, that the applicants are an experienced undertaking, which had for a long time monitored the steps taken by generic undertakings in relation to citalopram (see, inter alia, recitals 172 to 183 of the contested decision). |
| 304 | Tožeči stranki sta še posebej pozorno spremljali podjetje Ranbaxy, ker sta imeli med januarjem in julijem 2001 pogoste stike z navedenim ciljem raziskati možnost uporabe citaloprama podjetja Ranbaxy, v resnici pa je šlo za njuno zavlačevalno strategijo (glej točke od 549 do 552 obrazložitve izpodbijanega sklepa). Poleg tega sta tožeči stranki maja 2002 izvedeli, da je podjetje Ranbaxy v Indiji vložilo dve patentni prijavi, za kateri sta po analizi reakcijskih shem podjetja Ranbaxy menili, da bi bili lahko v nasprotju s patentoma za amid in jod (glej točke od 560 do 564 izpodbijanega sklepa). | 304 | The applicants had monitored Ranbaxy, in particular, especially closely, since, between January and July 2001, they had had frequent contacts, with the stated aim of exploring the possibility of using Ranbaxy’s citalopram, whereas it was in reality a delaying tactic on their part (see recitals 549 to 552 of the contested decision). In addition, in May 2002, the applicants learned that Ranbaxy had filed two patent applications in India and, after analysing Ranbaxy’s reaction schemes, they considered that those application could be in conflict with the amide and iodo patents (see recitals 560 to 564 of the contested decision). |
| 305 | Tožeči stranki se celo po podpisu sporazuma Ranbaxy nista nikoli pritoževali, da sta bili žrtvi blefiranja, ampak sta bili – kot izhaja iz točke 206 obrazložitve izpodbijanega sklepa – decembra 2002 zelo zadovoljni, da sta dosegli preložitev dajanja generičnega citaloprama na trg, določeno za prvo trimesečje leta 2002, s čimer so bile ustvarjene ugodne razmere za razvoj prodaje njunega novega zdravila, Cipralexa (glej točko 22 zgoraj). Ta sporazum sta s podpisom aneksa 19. februarja 2003 želeli celo podaljšati do 31. decembra 2003. Brez kakršnega koli dokaza v zvezi s tem pa ni verjetno, da bi lahko podjetje Ranbaxy v tako dolgem obdobju dvakrat preslepilo družbo Lundbeck. | 305 | Even after the Ranbaxy agreement had been signed, the applicants never complained that they had been the victims of a bluff; rather, as can be seen from recital 206 of the contested decision, they were delighted, in December 2002, that they had delayed the launch of generic citalopram, expected for the first quarter of 2002, which would have a positive effect on the sales development of their new medicinal product, Cipralex (see paragraph 22 above). They even wanted to extend that agreement until 31 December 2003 by signing an addendum, on 19 February 2003. In the absence of any evidence to that effect, it is not credible that Ranbaxy could have deceived Lundbeck twice, over such a long period. |
| 306 | Poleg tega je podjetje Ranbaxy – kot izhaja med drugim iz točke 1105 obrazložitve izpodbijanega sklepa – pred in po sklenitvi sporazuma Ranbaxy tretjim osebam zatrjevalo, da se z njegovimi postopki ne kršijo novi patenti družbe Lundbeck. Natančneje, Komisija je v točkah 554, 557 in 1093 obrazložitve izpodbijanega sklepa ugotovila, da je imelo podjetje Ranbaxy stike s podjetjem Arrow, najprej januarja in nato aprila leta 2002, ki so se končali s konkretno ponudbo zadnjenavedenemu v zvezi s prodajo od 500 do 1000 kg AFU. Ni pa verjeti, da je podjetje Ranbaxy svojim potencialnim strankam namenoma dajalo napačne informacije, da bi jih prepričalo v nakup svoje AFU. S takim ravnanjem bi se namreč izpostavilo odškodninskim tožbah svojih strank. Poleg tega je ena od teh od podjetja Ranbaxy prejela vso potrebno dokumentacijo za dokazovanje, da njegovi postopki niso ponarejeni. | 306 | In addition, it can be seen, inter alia, from recital 1105 of the contested decision, that before and after the conclusion of the Ranbaxy agreement, Ranbaxy stated to third parties that its processes did not infringe Lundbeck’s new patents. In particular, in recitals 554, 557 and 1093 of the contested decision, the Commission noted that Ranbaxy had had contacts with Arrow, first in January, then in April 2002, which ended with a concrete offer to the latter in relation to the sale of 500 to 1000 kg of API. It is not credible that Ranbaxy would have deliberately given false information to its potential customers with the aim of convincing them to purchase its API. Such conduct would have exposed it to actions for damages brought by those customers. Moreover, one of those customers had received from Ranbaxy all the documentation necessary to support the fact that its processes were not infringing. |
| 307 | To, da podjetje Ranbaxy ni moglo „blefirati“ tožečima strankama, potrjujejo tudi drugi dokazi, ki jih je Komisija navedla v izpodbijanem sklepu. | 307 | That Ranbaxy was not ‘bluffing’ the applicants is also confirmed by other evidence which the Commission adduced in the contested decision. |
| 308 | Tako je treba, prvič, spomniti da je podjetje Ranbaxy – kot je Komisija ugotovila v točki 1091 obrazložitve izpodbijanega sklepa – postopek za proizvodnjo citaloprama začelo razvijati že januarja leta 2001. Iz dokumenta, navedenega v točkah 552 in 1091 obrazložitve izpodbijanega sklepa, izhaja, da je bilo podjetje Ranbaxy, ko ga je družba Lundbeck julija leta 2001 obvestila, da ne želi kupiti 400 kg AFU, ki ji ga je to podjetje ponudilo, še posebej razočarano, ker se je ves čas pred tem, ko je družba Lundbeck dajala vtis, da se zanima za njegovo AFU, namenoma odreklo drugim razpoložljivim možnostim. | 308 | Thus, first, it must be recalled that, as the Commission noted in recital 1091 of the contested decision, Ranbaxy had already begun to develop a process to produce citalopram in January 2001. It can be seen from the document cited in recitals 552 and 1091 of the contested decision that, when, in July 2001, Lundbeck informed Ranbaxy that it did not wish to purchase the 400 kg of API that Ranbaxy had proposed, Ranbaxy was particularly disappointed because, throughout the previous period, in the course of which Lundbeck had led it to believe that it had an interest in Ranbaxy’s API, Ranbaxy had deliberately waived other opportunities. |
| 309 | Drugič, Komisija je v točkah 566 in 1092 obrazložitve izpodbijanega sklepa ugotovila, najprej, da je podjetje Ranbaxy decembra leta 2001 potencialni stranki v Italiji dalo tehnične podatke o svoji AFU, potem pa v prvi polovici leta 2002 16 kg AFU. Nato je januarja leta 2002 tudi potencialna stranka v Franciji prejela tehnične podatke. Pozneje leta 2002 je podjetje Ranbaxy potencialni švedski stranki poslalo majhno količino AFU. | 309 | Secondly, in recitals 566 and 1092 of the contested decision, the Commission found, first of all, that Ranbaxy had sent technical data concerning its API to a potential customer in Italy in December 2001, followed, in the first semester of 2002, by 16 kg of API. Next, in January 2002, a potential customer in France had also received technical data. Subsequently in 2002, Ranbaxy had sent a small quantity of API to a potential Swedish customer. |
| 310 | Tretjič, ugotoviti je treba – kot je Komisija izpostavila v točki 584 obrazložitve izpodbijanega sklepa – da je podjetje Ranbaxy julija leta 2002 prodalo majhno količino svoje AFU isti italijanski stranki, s katero je bila v stiku nekaj mesecev pred tem. Če pa je podjetje Ranbaxy lahko prodalo majhno količino AFU tik po sklenitvi spornega sporazuma, je imelo vsaj dejanske in konkretne možnosti to storiti že prej. | 310 | Thirdly, it must be observed that, as the Commission pointed out in recital 584 of the contested decision, in July 2002, Ranbaxy sold a small quantity of its API to the Italian customer with whom it had been in contact a few months earlier. If Ranbaxy was able to sell a small quantity of API just after the conclusion of the Ranbaxy agreement, it must at the very least have had real concrete possibilities to do so before then. |
| 311 | Nazadnje je treba ugotoviti, da se je podjetje Ranbaxy celo po tem, ko sta tožeči stranki proučili njegove reakcijske sheme, odločilo vložiti svoj DMF pri pristojnih organih Združenega kraljestva in nato vlogo za DZP. Ti ukrepi pa ne bi bili izvedeni, če bi bilo po navedeni proučitvi ugotovljeno, da se s postopkom, ki ga za proizvodnjo svoje AFU uporablja podjetje Ranbaxy, kršita patenta za amid in jod. | 311 | Lastly, it must be noted that, even after the applicants had examined its reaction schemes, Ranbaxy decided to file its DMF with the competent United Kingdom authorities and then applied for an MA. Those steps would not have been taken if, following that examination, it had been concluded that the process used by Ranbaxy to produce its API infringed the amide and iodo patents. |
| 312 | Na drugem mestu, v zvezi s trditvijo tožečih strank glede potrebnega roka za pridobitev DZP, je treba spomniti na preudarke iz točk 171, 177 in 178 zgoraj ter na roke, ki jih je podjetje Ranbaxy navedlo na sestanku z dne 17. aprila 2002 (glej točko 299, tretja in četrta alineja, zgoraj). | 312 | In the second place, as regards the applicants’ argument relating to the period necessary to obtain an MA, it is necessary to recall the considerations set out in paragraphs 171, 177 and 178 above as well as the evidence relating to the periods stated by Ranbaxy at the meeting of 17 April 2002 (see paragraph 299, third and fourth indents, above). |
| 313 | Ker so namreč na eni strani ukrepi generičnega podjetja, kakršno je podjetje Ranbaxy, za pripravo na vstop na trg z generičnim citalopramom, tudi tisti v zvezi s potrebnim postopkom za pridobitev DZP, upoštevni pri presoji potencialne konkurence, na drugi strani pa je družba Lundbeck te ukrepe jemala resno, je brezpredmetno, ali bi se potrebni postopki za pridobitev DZP lahko končali v rokih, ki jih je predvidelo podjetje Ranbaxy, ali pozneje. | 313 | Since the steps taken by a generic undertaking such as Ranbaxy in order to prepare its entry to the market with generic citalopram, including as regards the procedures necessary to obtain MAs, are relevant for the assessment of potential competition and, moreover, those steps were taken seriously by Lundbeck, it is irrelevant whether the procedures necessary in order to obtain those MAs could succeed within the periods envisaged by Ranbaxy, or later. |
| 314 | Pojasniti je treba, da je končan postopek za pridobitev DZP sicer nujen za obstoj dejanske konkurence, vendar pa je postopek za njegovo pridobitev, kadar ga sproži podjetje, ki se že dolgo resno pripravlja na vstop na trg, izraz potencialne konkurence, čeprav lahko v resnici zahteva več časa, kot ga zainteresirani predvidevajo. | 314 | It must be noted that, although the success of the procedure to obtain an MA is indispensable in order for effective competition to exist, the path to obtaining such an MA, when it is taken by an undertaking which has for a long time been seriously preparing its market entry, constitutes potential competition, even though it may in fact take longer than envisaged by the interested parties. |
| 315 | V zvezi s tem je treba ugotoviti – tudi če je podjetje Ranbaxy podcenilo trajanje potrebnega postopka za pridobitev DZP – prvič, da je družba Lundbeck kljub temu čutila toliko konkurenčnega pritiska, da je verjela, da je v njenem interesu plačilo prvonavedenemu za omejitev ali celo izključitev njegovega dostopa do trga med trajanjem sporazuma Ranbaxy. | 315 | In that respect, even if Ranbaxy underestimated the period necessary in order to obtain an MA, it must be noted, first, that Lundbeck nevertheless felt competitive pressure, to the point that it believed it to be in its interest to pay Ranbaxy in order to limit, or even exclude, its access to the market during the term of the Ranbaxy agreement. |
| 316 | Drugič, to plačilo je zmanjšalo potrebo podjetja Ranbaxy, da kar najbolj pospeši izdajo DZP, ker si je s sklenitvijo spornih sporazumov glede na svojo velikost zagotovilo znaten donos v zameno za to omejitev ali izključitev. To, da je zaradi „preoblikovanja“ dokumentacije svojo vlogo za DZP vložilo avgusta leta 2002, čeprav so bili po ugotovitvah Komisije iz opombe 1887 izpodbijanega sklepa vsi upoštevni rezultati testov poslani iz Indije junija, potrjuje da se mu po sklenitvi sporazuma z družbo Lundbeck ni posebej mudilo s pridobitvijo DZP. | 316 | Secondly, that payment necessarily made Ranbaxy’s need to accelerate as much as possible the procedure for obtaining an MA less pressing, since, by concluding the Ranbaxy agreement, it was ensured significant profits, given its scale, in consideration for that limitation or exclusion. The fact that, as a result of a ‘reformatting’ of the dossier, it filed its MA request in August 2002, even though, according to the Commission’s findings in footnote 1887 of the contested decision, all the relevant test results had been sent from India in June, confirms that it was not in any particular hurry to obtain an MA, after the conclusion of the agreement concluded with Lundbeck. |
| 317 | Vsekakor je treba najprej ugotoviti, da morajo v skladu s členom 17(1) Direktive 2001/83 države članice sprejeti vse ustrezne ukrepe, da zagotovijo, da se postopek za pridobitev dovoljenja za promet z zdravilom konča v 210 dneh od predložitve popolne vloge. Če bi torej podjetje Ranbaxy vložilo vlogo z vsemi potrebnimi podatki, bi jo morali pristojni organi obravnavati v krajšem roku, kot je osem mesecev, navedenih v zapisniku sestanka z dne 17. aprila 2002. | 317 | In any event, it must be noted, first of all, that according to Article 17(1) of Directive 2001/83, the Member States are to take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 210 days after the submission of a valid application. Thus, if Ranbaxy had made a request containing all the necessary information, the competent authorities would have treated it in a period even briefer than the eight months mentioned in the minutes of the meeting of 17 April 2002. |
| 318 | Res je, da se navedeni rok 210 dni, določen v členu 17(1) Direktive 2001/83, prekine, če pristojni organ meni, da vloga ni popolna in pozove zadevno podjetje, naj predloži dodatne podatke. | 318 | It is true that that period of 210 days laid down by Article 17(1) of Directive 2001/83 is suspended if the competent authority considers that an application is not valid and asks the undertaking concerned to provide it with further information. |
| 319 | Vendar družba Lundbeck ob sestavi zapisnika sestanka z dne 17. aprila 2002 ni omenila, da osemmesečni rok, ki ga je predvidevalo podjetje Ranbaxy, ni uresničljiv, ampak je samo ugotovila, da bi lahko sporazum stal od 10 do 20 milijonov USD ali celo več (točka 1095 obrazložitve izpodbijanega sklepa). | 319 | However, when it drafted the minutes of the meeting of 17 April 2002, Lundbeck did not insert a remark to indicate that the period of eight months envisaged by Ranbaxy was unrealistic, but only noted that an agreement could cost USD 10 to 20 million or more (recital 1095 of the contested decision). |
| 320 | It tega sledi, da je imelo podjetje Ranbaxy dejansko in konkretno možnost pridobiti DZP med trajanjem sporazuma Ranbaxy, kar je v okoliščinah zadeve zadostovalo za vršenje konkurenčnega pritiska na družbo Lundbeck. | 320 | It follows that Ranbaxy had a real concrete possibility of obtaining an MA during the term of the Ranbaxy agreement, which was sufficient, in the circumstances of the present case, to exert a competitive pressure on Lundbeck. |
| 321 | Dalje, spomniti je treba, da je imelo podjetje Ranbaxy v skladu z zapisnikom sestanka z dne 17. aprila 2002 možnost kupiti obstoječe DZP ali svojo AFU prodati generičnemu podjetju, ki že ima DZP, vendar je bila pri teh dveh možnostih potrebna sprememba navedenih DZP tipa II. | 321 | Next, it must be recalled that according to the minutes of the meeting of 17 April 2002, Ranbaxy had the possibility of purchasing an existing MA or of selling its API to a generic undertaking which already held an MA. Those two options required, however, that those MAs be subject to a Type II variation. |
| 322 | Ugotoviti je treba – kot je bilo ugotovljeno zgoraj v točkah 306 in 309 – da je podjetje Ranbaxy pred sklenitvijo sporazuma z družbo Lundbeck izvedlo več ukrepov za prodajo svoje AFU in ne za prodajo končnih proizvodov, proizvedenih iz nje. To, da bi bila lahko prodaja končnih proizvodov donosnejša, ne onemogoča sklepa, da je bila prodaja AFU dejanska in konkretna možnost podjetja Ranbaxy za konkuriranje družbi Lundbeck, kot je bilo navedeno v zapisniku sestanka z dne 17. aprila 2002. | 322 | It must be noted that, as was pointed out in paragraphs 306 and 309 above, before concluding the agreement with Lundbeck, Ranbaxy had taken several steps to sell its API, and not to sell finished products made from that API. The fact that the sale of finished products may have been more profitable does not prevent the sale of its API being considered as a real concrete possibility for Ranbaxy to compete with Lundbeck, as was mentioned in the minutes of the meeting of 17 April 2002. |
| 323 | Nazadnje, kot je Komisija izpostavila v opombi 1885 izpodbijanega sklepa, je rok od treh do štirih mesecev, omenjen v zapisniku sestanka z dne 17. aprila 2002, združljiv s statistiko pristojnega organa Združenega kraljestva v zvezi s trajanjem postopkov spremembe tipa II, ki jo je Komisija predložila Splošnemu sodišču in iz katere izhaja, da se je med marcem 2001 in februarjem 2002 večina teh postopkov končala v devetdesetih dneh. | 323 | Lastly, as the Commission mentioned in footnote No 1885 of the contested decision, the period of three to four months mentioned in the minutes of the meeting of 17 April 2002 is compatible with the statistics of the competent United Kingdom authority concerning the period of the procedures relating to Type II variations that the Commission produced before the Court, from which it follows that, between March 2001 and February 2002, most of those procedures were completed within a period of 90 days. |
| 324 | V zvezi s tem je sicer res – kot izhaja iz uvodnih pojasnil k navedeni statistiki – da se je navedeno obdobje računalo od vložitve popolne vloge, brez upoštevanja prekinitev zaradi zahtev po dodatnih podatkih. Vendar je pristojni organ Združenega kraljestva – kot je Komisija izpostavila v odgovoru na vprašanje Splošnega sodišča – potrdil, da je bilo v obdobju, ki ga zajema zadevna statistika, o petdesetih odstotkih vlog za spremembe tipa II odločeno v največ devetdesetih dneh. V štiridesetih odstotkih primerov namreč ni bilo nobene zahteve po dodatnih podatkih, v desetih odstotkih primerov pa taka zahteva ni podaljšala postopka prek navedenega roka. | 324 | In that respect, it is true that, as can be seen from the introductory explanations to those statistics, that period was calculated on the basis of the filing of a complete application, without taking into account suspensions due to requests for further information. However, as the Commission stated in its reply to a question from the Court, the competent United Kingdom authority confirmed that, during the period referred to by the statistics at issue, 50% of applications for Type II variations submitted were determined within a maximum period of 90 days. In 40% of cases, no request for further information was made and, in 10% of cases, the sending of such a request did not extend the procedure beyond that period of 90 days. |
| 325 | Ta statistika torej potrjuje, da je obstajala dejanska in konkretna možnost spremembe obstoječega DZP, tako da bi se nanašalo na citalopram, proizveden po postopkih podjetja Ranbaxy, v roku, kakršen je omenjen v zapisniku sestanka z dne 17. aprila 2002, ker bi vloga za spremembo lahko spadala med enega od primerov iz točke 324 zgoraj. | 325 | Those statistics therefore confirm that there was a real concrete possibility of varying an existing MA so that it referred to the citalopram produced in accordance with the Ranbaxy processes within a period of the order of that mentioned in the minutes of the meeting of 17 April 2002, since the application for a variation could fall within one of the cases referred to in paragraph 324 above. |
| 326 | Poleg tega je treba ugotoviti, da se pojasnila pristojnega organa Združenega kraljestva iz časa po podpisu sporazuma Ranbaxy in celo po sprejetju izpodbijanega sklepa – ker so bila predložena za namene postopka pred Splošnim sodiščem – nanašajo na položaj v času pogajanj o spornih sporazumih in zagotavljajo podrobnosti za razlago dejavnikov iz izpodbijanega sklepa. Zato je ta pojasnila mogoče upoštevati pod pogoji, navedenimi zgoraj v točkah od 138 do 141. | 326 | Moreover, it must be noted that, although the explanations provided by the competent United Kingdom authority date from after the conclusion of the Ranbaxy agreement and even after the adoption of the contested decision, given that they were provided for the purposes of the proceedings before the Court, they refer to the prevailing situation at the time the Ranbaxy agreement was being negotiated and provide details for the interpretation of the factors set out in the contested decision. Thus, those explanations may be taken into account under the conditions referred to in paragraphs 138 to 141 above. |
| 327 | Na tretjem mestu, v zvezi z navedbo podjetja Ranbaxy, po kateri citaloprama med trajanjem sporazuma Ranbaxy po juniju 2002 ni prodajalo v Evropi ali drugod po svetu (glej točko 577 obrazložitve izpodbijanega sklepa), je treba ugotoviti, da to ni upoštevna okoliščina za presojo potencialne konkurence v EGP v času sklenitve navedenega sporazuma. To, da podjetje Ranbaxy ni prodajalo niti zunaj EGP, namreč kvečjemu dokazuje, da to podjetje ni bilo dejanski konkurent družbe Lundbeck zunaj EGP, nikakor pa ne vpliva na obstoj potencialne konkurence bodisi v EGP bodisi zunaj njega. Sicer pa je treba ugotoviti, da Komisiji ni bilo treba analizirati potencialne konkurence zunaj EGP. | 327 | In the third place, as regards the fact that Ranbaxy stated that, during the term of the Ranbaxy agreement, it had not sold any citalopram in Europe, or in the entire world after June 2002 (see recital 577 of the contested decision), it must be pointed out that it is not relevant to the assessment of potential competition in the EEA at the time that agreement was concluded. The fact that Ranbaxy also made no sales outside the EEA demonstrates, at most, that that undertaking was not in actual competition with Lundbeck outside the EEA, but has no impact on the existence of a relationship of potential competition, whether within the EEA or outside that territory. Moreover, it must be noted that the Commission was in no way required to examine potential competition outside the EEA. |
| 328 | Na četrtem mestu, v zvezi s trditvijo tožečih strank, da ju je podjetje Ranbaxy januarja leta 2004 prosilo za licenco za patent za jod, ki je bil izdan 23. marca 2003, je treba ugotoviti, da to ne pomeni, da pred letom 2004 ni imelo dejanskih in konkretnih možnosti za vstop na trg s svojimi proizvodi. Razlogi za prošnjo za licenco so namreč lahko različni, kot na primer preprečitev tožbe zaradi kršitev. Možno je, da je podjetje Ranbaxy ocenilo, da bi se tožeči stranki strinjali z odobritvijo licence po znižani ceni, s čimer bi se z majhnimi stroški zaščitilo pred tveganjem potencialne kršitve patenta za jod. Zato sporazum o licenci ne vpliva na vprašanje, ali sta bili v času sklenitve sporazuma Ranbaxy potencialni konkurentki podjetja Ranbaxy. | 328 | In the fourth place, as regards the applicants’ argument relating to the fact that, in January 2004, Ranbaxy asked them for a licence covering the iodo patent, granted on 23 March 2003, it must be pointed out that this does not mean that it did not have real concrete possibilities of entering the market with its products before 2004. A licence request may be motivated by several different reasons, such as avoiding any infringement action. Ranbaxy may have believed that the applicants would grant it a licence at a reduced price, which would have allowed it to protect itself, at a low cost, from any risk of potentially infringing the iodo patent. Accordingly, the licence agreement invoked by the applicants is not decisive to the issue whether they were potential competitors of Ranbaxy at the time the Ranbaxy agreement was concluded. |
| 329 | Na petem mestu, tako kot tožeči stranki je treba ugotoviti, da se v izpodbijanem sklepu, kot kaže, nikjer ne omenjajo dvomi v veljavnost patentov za amid in jod. Vendar je treba ugotoviti – poleg tega, da patent za jod ob sklenitvi sporazuma Ranbaxy še ni bil podeljen in torej ne bi mogel biti uporabljen kot podlaga za tožbo zaradi kršitev – da presoja potencialne konkurence med družbo Lundbeck in podjetjem Ranbaxy v izpodbijanem sklepu temelji na dokazih, ki dokazujejo, da se je podjetje Ranbaxy pripravljalo za vstop na trg, ker je menilo, da njegov postopek ni ponarejen, in ne na možnosti, da doseže razveljavitev patentov družbe Lundbeck, ki bi bili lahko kršeni. | 329 | In the fifth place, it must be noted, as the applicants submit, that the contested decision does not appear to contain any reference to the existence of doubts as to the validity of the amide and iodo patents. However, apart from the fact that the iodo patent had not been granted when the Ranbaxy agreement was concluded, with the result that it could not be used as a basis for an infringement action, it must be noted that the assessment of the potential competition between Lundbeck and Ranbaxy carried out in the contested decision is based on the evidence showing that Ranbaxy was preparing to enter the market because it considered that its process was not infringing, rather that the possibility of obtaining the cancellation of those of Lundbeck’s patents which were liable to be infringed. |
| 330 | Ob upoštevanju navedenega je treba deveti del, in prvi tožbeni razlog v celoti, zavrniti. | 330 | In the light of the foregoing, the ninth part of the first plea in law must be rejected, as must the first plea in law in its entirety. |
| II – Drugi, tretji, četrti, peti in šesti tožbeni razlog: v bistvu gre za kršitev člena 101(1) PDEU | II – The second, third, fourth, fifth and sixth pleas in law, alleging, in essence, infringement of Article 101(1) TFEU |
| 331 | Pred obravnavanjem trditev tožečih strank v zvezi z vsebino, namenom in okvirom spornih sporazumov je treba na kratko povzeti, kako je Komisija v izpodbijanem sklepu pristopila k opredelitvi spornih sporazumov kot omejitev konkurence „zaradi cilja“ v obravnavani zadevi, in upoštevno sodno prakso. | 331 | Before examining the applicants’ arguments relating to the content, the purpose and the context of the agreements at issue, it is appropriate to summarise briefly the approach taken by the Commission in the contested decision in finding that the agreements at issue in the present case were a restriction of competition ‘by object’, and the relevant case-law. |
| A – Analiza obstoja omejitve konkurence „zaradi cilja “ v izpodbijanem sklepu | A – Analysis relating to the existence of a restriction of competition ‘by object ’ in the contested decision |
| 332 | Komisija je v izpodbijanem sklepu presodila, da so sporni sporazumi omejitev konkurence „zaradi cilja“ v smislu člena 101(1) PDEU, pri čemer se je oprla na več dejavnikov v zvezi z vsebino, okvirom in namenom navedenih sporazumov (točke od 61 do 67 zgoraj). | 332 | The Commission considered, in the contested decision, that the agreements at issue constituted a restriction of competition ‘by object’, for the purpose of Article 101(1) TFEU by relying, in that respect, on a series of factors relating to the content, the context and the purpose of those agreements (paragraphs 61 to 67 above). |
| 333 | Tako je menila, da je bil pomemben dejavnik gospodarskega in pravnega okvira, v katerem so bili sklenjeni sporni sporazumi, to, da so izvirni patenti družbe Lundbeck potekli pred sklenitvijo spornih sporazumov, vendar je zadnjenavedena v času sklenitve teh sporazumov pridobila – ali je bila tik pred tem, da pridobi – več patentiranih postopkov, med njimi patent za kristalizacijo. Vendar je Komisija menila, da patent ne daje pravice do omejevanja poslovne samostojnosti strank onkraj pravic, ki jih ta patent zagotavlja (točka 638 obrazložitve izpodbijanega sklepa). | 333 | It therefore found that the fact that Lundbeck’s original patents had expired before the conclusion of the agreements at issue, but that it had obtained — or was about to obtain — several process patents at the time those agreements were concluded, including the crystallisation patent, was a significant element of the economic and legal context in which the agreements at issue were concluded. The Commission took the view, however, that a patent did not grant the right to limit the commercial autonomy of parties by going beyond the rights granted by that patent (recital 638 of the contested decision). |
| 334 | Zato je menila, da z vidika prava konkurence vse patentne poravnave niso nujno problematične, vendar pa je tako, kadar taki sporazumi določajo izključitev s trga ene od strank, ki je vsaj potencialna konkurentka druge stranke, za določen čas, in kadar se na njihovi podlagi prenese vrednost imetnika patenta v korist generičnega podjetja, ki bi lahko kršilo ta patent (v nadaljevanju: obrnjena plačila) (točki 639 in 640 obrazložitve izpodbijanega sklepa). | 334 | It thus considered that although all patent settlements were not necessarily problematic from a competition law perspective, such agreements were problematic where they provided for the exclusion from the market of one of the parties, which was at the very least a potential competitor of the other party, for a certain period, and where they were accompanied by a transfer of value from the patent holder to the generic undertaking liable to infringe that patent (‘reverse payments’) (recitals 639 and 640 of the contested decision). |
| 335 | Iz izpodbijanega sklepa izhaja tudi, da tudi če omejitve iz spornih sporazumov spadajo na področje uporabe patentov družbe Lundbeck (torej, da sporazumi preprečujejo samo vstop generičnega citaloprama, za katerega stranke sporazuma ocenjujejo, da je ponarejen, in ne katere koli vrste generičnega citaloprama), pa se z njimi kljub temu omejuje konkurenca „zaradi cilja“, ker se z njimi prepreči ali naredi nesmiselno kakršno koli izpodbijanje patentov družbe Lundbeck pri nacionalnih sodiščih, po mnenju Komisije pa je tovrstno izpodbijanje del običajnega konkurenčnega procesa na področju patentov (točke od 603 do 605, 625, 641 in 674 obrazložitve izpodbijanega sklepa). | 335 | It can also be seen from the contested decision that, even if the restrictions set out in the agreements at issue fell within the scope of the Lundbeck patents — that is to say that the agreements prevented only the market entry of generic citalopram deemed to potentially infringe those patents by the parties to the agreements and not that of every type of generic citalopram — they would nevertheless constitute restrictions on competition ‘by object’, since, inter alia, they prevented or rendered pointless any type of challenge to Lundbeck’s patents before the national courts, whereas, according to the Commission, that type of challenge is part of normal competition in relation to patents (recitals 603 to 605, 625, 641 and 674 of the contested decision). |
| 336 | Drugače povedano, po mnenju Komisije naj bi se s spornimi sporazumi negotovost v zvezi z izidom takih sporov spremenila v gotovost, da generiki ne bodo vstopili na trg, kar je prav tako lahko omejitev konkurence zaradi cilja, kadar te omejitve ne izhajajo iz presoje strank o prednosti zadevne izključne pravice, ampak iz višine obrnjenega plačila, ki v takem primeru zasenči tako presojo in spodbudi generično podjetje, da si samostojno ne prizadeva za vstop na trg (točka 641 obrazložitve izpodbijanega sklepa). | 336 | In other words, according to the Commission, the agreements at issue transformed the uncertainty in relation to the outcome of such litigation into the certainty that the generics would not enter the market, which may also constitute a restriction on competition by object when such limits do not result from an assessment, by the parties, of the merits of the exclusive right at issue, but rather from the size of the reverse payment which, in such a case, overshadows that assessment and induces the generic undertaking not to pursue its independent efforts to enter the market (recital 641 of the contested decision). |
| 337 | Na podlagi teh preudarkov je treba obravnavati trditve tožečih strank, s katerimi skušata izpodbiti obstoj omejitve zaradi cilja v obravnavani zadevi. | 337 | The applicants’ arguments seeking to call into question the existence of a restriction by object in the present case must be examined in the light of those considerations. |
| B – Uporabljiva načela in sodna praksa | B – Applicable principles and case-law |
| 338 | Spomniti je treba, da člen 101(1) PDEU določa, da so „[k]ot nezdružljivi z notranjim trgom […] prepovedani vsi sporazumi med podjetji, sklepi podjetniških združenj in usklajena ravnanja, […] katerih cilj oziroma posledica je preprečevanje, omejevanje ali izkrivljanje konkurence na notranjem trgu, zlasti tisti, ki: | (a) | neposredno ali posredno določajo nakupne ali prodajne cene ali druge pogoje poslovanja; | (b) | omejujejo ali nadzorujejo proizvodnjo, trge, tehnični razvoj ali naložbe; | (c) | določajo razdelitev trgov in virov nabave; | (d) | uvajajo neenake pogoje za primerljive posle z drugimi trgovinskimi partnerji in jih tako postavljajo v podrejen konkurenčni položaj; | (e) | sklepanje pogodb, ki sopogodbenikom narekujejo sprejetje dodatnih obveznosti, ki po svoji naravi ali glede na trgovinske običaje nimajo nikakršne zveze s predmetom takšnih pogodb“. | 338 | It must be recalled that Article 101(1) TFEU provides that ‘the following shall be prohibited as incompatible with the internal market: all agreements between undertakings, decisions by associations of undertakings and concerted practices ... which have as their object or effect the prevention, restriction or distortion of competition within the internal market, and in particular those which: | (a) | directly or indirectly fix purchase or selling prices or any other trading conditions; | (b) | limit or control production, markets, technical development, or investment; | (c) | share markets or sources of supply; | (d) | apply dissimilar conditions to equivalent transactions with other trading parties, thereby placing them at a competitive disadvantage; | (e) | make the conclusion of contracts subject to acceptance by the other parties of supplementary obligations which, by their nature or according to commercial usage, have no connection with the subject of such contracts.’ |
| 339 | V zvezi s tem je iz sodne prakse razvidno, da so nekatere vrste dogovarjanja med podjetji za konkurenco tako škodljive, da je mogoče šteti, da ugotavljanje njihovih posledic ni potrebno (zgoraj v točki 78 navedena sodba CB/Komisija, EU:C:2014:2204, točka 49; glej v tem smislu tudi sodbi z dne 30. junija 1966, LTM, 56/65, ZOdl., EU:C:1966:38, točki 359 in 360, in z dne 14. marca 2013, Allianz Hungária Biztosító in drugi, C‑32/11, ZOdl., EU:C:2013:160, točka 34). | 339 | In that regard, it is apparent from the case-law that certain types of coordination between undertakings reveal a sufficient degree of harm to competition for the examination of their effects to be considered unnecessary (judgment in CB v Commission, cited in paragraph 78 above, EU:C:2014:2204, paragraph 49; see also, to that effect, judgments of 30 June 1966 in LTM, 56/65, ECR, EU:C:1966:38, pp. 359 and 360, and 14 March 2013 in Allianz Hungária Biztosító and Others, C‑32/11, ECR, EU:C:2013:160, paragraph 34). |
| 340 | Ta sodna praksa izhaja iz dejstva, da je mogoče nekatere oblike dogovarjanja med podjetji že zaradi njihove narave obravnavati kot škodljive za dobro delovanje običajnega konkurenčnega trga (zgoraj v točki 78 navedena sodba CB/Komisija, EU:C:2014:2204, točka 50; glej v tem smislu tudi zgoraj v točki 339 navedeno sodbo Allianz Hungária Biztosító in drugi, EU:C:2013:160, točka 35 in navedena sodna praksa). | 340 | That case-law arises from the fact that certain forms of coordination between undertakings can be regarded, by their very nature, as being injurious to the proper functioning of normal competition (judgment in CB v Commission, cited in paragraph 78 above, EU:C:2014:2204, paragraph 50; see also, to that effect, judgment in Allianz Hungária Biztosító and Others, cited in paragraph 339 above, EU:C:2013:160, paragraph 35 and the case-law cited). |
| 341 | Posledično je ustaljeno, da je mogoče šteti, da imajo nekatera tajna ravnanja, kot so tista, katerih posledica je to, da karteli določijo horizontalne cene, ali s katerimi so nekateri konkurenti izključeni s trga, tako negativne posledice zlasti na ceno, količino ter kakovost proizvodov in storitev, da za namene uporabe člena 101(1) PDEU ni treba dokazovati njihovih konkretnih posledic za trg. Izkušnje namreč kažejo, da taka ravnanja pomenijo zmanjšanje proizvodnje in zvišanje cene, kar negativno vpliva na razdelitev virov zlasti na škodo potrošnikov (glej zgoraj v točki 78 navedeno sodbo CB/Komisija, EU:C:2014:2204, točka 51 in navedena sodna praksa; glej v tem smislu tudi sodbo z dne 20. novembra 2008, Beef Industry Development Society in Barry Brothers, C‑209/07, ZOdl., v nadaljevanju: sodba BIDS, EU:C:2008:643, točki 33 in 34). | 341 | Consequently, it is established that certain collusive behaviour, such as that leading to horizontal price-fixing by cartels or consisting in the exclusion of some competitors from the market, may be considered so likely to have negative effects, in particular on the price, quantity or quality of the goods and services, that it may be considered redundant, for the purposes of applying Article 101(1) TFEU, to prove that they have actual effects on the market. Experience shows that such behaviour leads to falls in production and price increases, resulting in poor allocation of resources to the detriment, in particular, of consumers (see judgment in CB v Commission, cited in paragraph 78 above, EU:C:2014:2204, paragraph 51 and the case-law cited; see also, to that effect, judgment of 20 November 2008 in Beef Industry Development Society and Barry Brothers, C‑209/07, ECR, ‘the BIDS judgment’, EU:C:2008:643, paragraphs 33 and 34). |
| 342 | Če se z analizo vrste dogovarjanja med podjetji ne ugotovi zadostna stopnja škodljivosti za konkurenco, pa je treba proučiti posledice takega dogovarjanja in za njegovo prepoved zahtevati predložitev dokazov, ki dokazujejo, da je bila konkurenca dejansko znatno preprečena, omejena ali izkrivljena (zgoraj v točki 339 navedena sodba Allianz Hungária Biztosító in drugi, EU:C:2013:160, točka 34, in zgoraj v točki 78 navedena sodba CB/Komisija, EU:C:2014:2204, točka 52). | 342 | Where the analysis of a type of coordination between undertakings does not reveal a sufficient degree of harm to competition, the effects of the coordination should, on the other hand, be considered and, for it to be caught by the prohibition, it is necessary to find that factors are present which show that competition has in fact been prevented, restricted or distorted to an appreciable extent (judgments in Allianz Hungária Biztosító and Others, cited in paragraph 339 above, EU:C:2013:160, paragraph 34, and CB v Commission, cited in paragraph 78 above, EU:C:2014:2204, paragraph 52). |
| 343 | Pri dokazovanju protikonkurenčnosti določenega sporazuma in presoji, ali je ta tako škodljiv, da se šteje za omejitev konkurence „zaradi cilja“ v smislu člena 101(1) PDEU, je treba upoštevati vsebino njegovih določb, cilje, ki se želijo z njim doseči, ter pravni in gospodarski okvir, v kateri je umeščen. Pri presoji navedenega okvira je treba upoštevati tudi naravo zadevnega blaga ali storitev ter dejanske pogoje delovanja in strukturo zadevnega trga ali trgov (zgoraj v točki 339 navedena sodba Allianz Hungária Biztosító in drugi, EU:C:2013:160, točka 36, in zgoraj v točki 78 navedena sodba CB/Komisija, EU:C:2014:2204, točka 53). | 343 | In order to establish the anticompetitive nature of an agreement and assess whether it reveals a sufficient degree of harm to competition that it may be considered a restriction of competition by object for the purpose of Article 101(1) TFEU, regard must be had to the content of its provisions, its objectives and the economic and legal context of which it forms a part. When determining that context, it is also necessary to take into consideration the nature of the goods or services affected, as well as the real conditions of the functioning and structure of the market or markets in question (judgments in Allianz Hungária Biztosító and Others, cited in paragraph 339 above, EU:C:2013:160, paragraph 36 and in CB v Commission, cited in paragraph 78 above, EU:C:2014:2204, paragraph 53). |
| 344 | Poleg tega lahko organi, pristojni za varstvo konkurence, nacionalna sodišča in sodišča Unije vseeno upoštevajo namen strank, čeprav to ni nujni dejavnik za opredelitev omejujoče narave sporazuma (zgoraj v točki 339 navedena sodba Allianz Hungária Biztosító in drugi, EU:C:2013:160, točka 37, in zgoraj v točki 78 navedena sodba CB/Komisija, EU:C:2014:2204, točka 54 in navedena sodna praksa). | 344 | In addition, although the parties’ intention is not a necessary factor in determining whether an agreement between undertakings is restrictive, there is nothing prohibiting the competition authorities, the national courts or the Courts of the European Union from taking that factor into account (judgments in Allianz Hungária Biztosító and Others, cited in paragraph 339 above, EU:C:2013:160, paragraph 37, and CB v Commission, cited in paragraph 78 above, EU:C:2014:2204, paragraph 54 and the case-law cited). |
| C – Drugi tožbeni razlog: očitno napačna uporaba prava in ugotovitev dejanskega stanja ter neobrazloženost pri presoji vloge prenosa vrednosti v spornih sporazumih | C – The second plea in law, alleging a manifest error of law and of fact and a failure to state reasons in assessing the role of value transfers in the agreements at issue |
| 345 | Po mnenju tožečih strank je bilo v sklepu napačno presojeno, da določitev plačil družbe Lundbeck v spornih sporazumih pomeni, da so imeli ti sporazumi protikonkurenčni cilj, saj naj bi iz teh plačil izhajalo, da omejitve iz vsakega od navedenih sporazumov ne ustrezajo presoji strank o moči upoštevnih patentov in njihovi kršitvi (prvi del). V izpodbijanem sklepu naj bi se tudi zmotno ugotovilo, da so omejitve iz spornih sporazumov zmanjševale ali odpravljale spodbude generičnim podjetjem, da si samostojno prizadevajo za vstop na trg, čeprav te omejitve niso presegale tistih, ki so vgrajene v obstoj patentov družbe Lundbeck. V izpodbijanem sklepu naj ne bi bilo dokazano, da so imela plačila družbe Lundbeck tak učinek, ali da se zadevne omejitve niso ujemale s presojo strank (drugi del). Teza Komisije v zvezi s tem naj ne bi bila skladna in uresničljiva ter naj bi uporabljala neizvedljiv pravni preizkus (tretji del). | 345 | According to the applicants, the decision errs where it takes the view that the fact that the agreements at issue provide for payments by Lundbeck means that those agreements had an anticompetitive object, on the ground that those payments showed that the restrictions in each of the agreements did not correspond to the parties’ assessments of the strength of the relevant patents and their infringement (first part). In addition, the decision errs when it concludes that the restrictions in the agreements at issue reduced or eliminated the generic undertakings’ incentives to pursue independently their efforts to enter the market even if those restrictions did not exceed the restrictions inherent in Lundbeck’s patents. The decision does not establish that the payments made by Lundbeck had that effect or that the restrictions in question did not correspond to the parties’ assessment (second part). The argument employed by the Commission in the contested decision in that respect is inconsistent and unrealistic and applies an unworkable legal test (third part). |
| 1. Prvi del | 1. The first part |
| 346 | Tožeči stranki menita, da je v izpodbijanem sklepu napačno uporabljeno pravo in napačno ugotovljeno dejansko stanje s tem, da se v njem ugotavlja, da sporni sporazumi ne odražajo ocene strank o moči patentov. | 346 | The applicants maintain that the decision is incorrect in law and in fact when it concludes that the agreements at issue did not reflect the parties’ assessment of the strength of the patents. |
| 347 | Opozarjata, da se v izpodbijanem sklepu ugotavlja, da je sporazum o poravnavi verjetno zakonit, ker „je bil sklenjen na podlagi nasprotujočih si ocen strank o stanju patentov“ (točka 604 obrazložitve), vendar bi se z omejitvami, določenimi v okviru poravnave, „lahko kršil člen 101 [PDEU], kadar teh omejitev ne bi bilo mogoče upravičiti in ne bi izhajale iz ocene strank o utemeljenosti izključne pravice“ (točka 641 obrazložitve). Ugotovitev iz izpodbijanega sklepa, da sporni sporazumi ne odražajo ocene strank o moči patentov na eni strani, pa naj ne bi bila podprta z nobenim pisnim dokazom, ki bi dokazoval nezaupanje strank v moč zadevnih patentov, na drugi strani pa naj bi temeljila na neutemeljeni domnevi, da prenosi vrednosti pomenijo, da se omejitve iz teh sporazumov ne ujemajo z oceno strank o moči navedenih patentov. | 347 | They observe that the contested decision states that a settlement agreement is probably lawful if it ‘has been reached on [the basis of] each party’s competing assessment of the patent situation’ (recital 604) but that the restrictions provided for in a settlement ‘are likely to breach Article 101 [TFEU] when those limitations cannot be justified and do not result from the parties’ assessment of the merits of the exclusive right itself’ (recital 641). However, the contested decision’s finding that the agreements at issue did not reflect the parties’ assessment of the strength of the patents (i) is not supported by any written evidence showing the parties’ lack of confidence in the strength of the patents and (ii) is based on an unfounded presumption that the value transfers meant that the restrictions in those agreements did not match the parties’ assessment of the strength of the patents. |
| 348 | Komisija te trditve zavrača. | 348 | The Commission disputes those arguments. |
| 349 | Spomniti je treba na to, da je Komisija v izpodbijanem sklepu ocenila, da je to, da so bile omejitve iz spornih sporazumov dosežene z znatnimi obrnjenimi plačili, odločilno za pravno presojo teh sporazumov (točka 660 obrazložitve izpodbijanega sklepa). | 349 | It must be recalled that the Commission considered, in the contested decision, that the fact that the restrictions contained in the agreements at issue had been obtained through significant reverse payments was decisive for the legal assessment of those agreements (recital 660 of the contested decision). |
| 350 | Kljub temu pa se v izpodbijanem sklepu priznava, da obstoj obrnjenega plačila v okviru patentne poravnave ni vedno problematičen, zlasti kadar je to plačilo povezano z močjo patenta, kot ga dojema vsaka od strank, kadar je potrebno za to, da se za vsako od strank najde sprejemljiva in legitimna rešitev, in kadar ni povezano z omejitvami, s katerimi se želi preložiti vstop generikov na trg (točki 638 in 639 obrazložitve izpodbijanega sklepa). Kot primer je navedena družba Neolab, s katero je družba Lundbeck prav tako sklenila poravnavo, ki ni bila obravnavana kot problematična, čeprav je določala obrnjeno plačilo, ker je bilo plačilo družbi Neolab opravljeno v zameno za njeno zavezo, da pri pristojnih sodiščih ne bo zahtevala odškodnine, in ker se je družba Lundbeck odpovedala uveljavljanju kakršnega koli patentnega zahtevka v določenem obdobju (točki 164 in 639 obrazložitve izpodbijanega sklepa). V tem primeru je bil namreč dejanski cilj obrnjenega plačila ureditev spora med strankama, ne pa preložitev vstopa generika na trg. | 350 | The contested decision nevertheless acknowledges that the existence of a reverse payment in the context of a patent settlement is not always problematic, particularly when (i) that payment is linked to the strength of the patent, as perceived by each of the parties, (ii) it is necessary in order to find an acceptable and legitimate solution in the eyes of the two parties and (iii) it is not accompanied by restrictions intended to delay the market entry of generics (recitals 638 and 639 of the contested decision). It thus took as an example the company Neolab, with which Lundbeck had also concluded a settlement agreement, which was not considered to be problematic — even though it involved a reverse payment — since that payment to Neolab had been made in exchange for a commitment on Neolab’s part not to seek damages before the competent courts and Lundbeck had agreed to not bring any claims under its patents during a certain period (recitals 164 and 639 of the contested decision). In that case, the actual object of the reverse payment was to settle a dispute between the parties, without, however, delaying the market entry of generics. |
| 351 | Čeprav je res – kot navajata tožeči stranki – da je v primeru družbe Neolab obstajala tudi prva poravnava med strankama, ki je določala preložitev vstopa družbe Neolab na trg do rešitve spora Lagap, pa ta poravnava ni bila povezana s prenosom vrednosti, ampak je bila pogojena s tem, da družba Lundbeck plača družbi Neolab odškodnino v primeru neugodne sodbe v tem sporu. Ko se je družba Lundbeck nazadnje odločila, da svoj spor z družbo Lagap poravna, je bila družba Neolab še vedno zainteresirana za pridobitev odškodnine, če bi dosegla neveljavnost patenta družbe Lundbeck. V tem okviru je družba Lundbeck raje poravnala svoj spor z družbo Neolab in pristala, da ji plača odškodnino za leto, ko se je umaknila s trga, ter se zavezala, da ne bo uveljavljala patentnih zahtevkov v primeru njenega vstopa na trg (točka 164 obrazložitve izpodbijanega sklepa). Zadnjenavedena zaveza je torej ključna, ker obrnjeno plačilo družbe Lundbeck v nasprotju s spornimi sporazumi v obravnavani zadevi ni pomenilo povračila za izključitev s trga, ampak je bilo povezano s sprejetjem neobstoja kršitev in zavezo za neoviranje vstopa generikov na trg. | 351 | Although it is true that, as the applicants submit, in Neolab’s case, there was also a first settlement agreement between the parties which provided that Neolab’s entry to the market would be delayed, pending the outcome of the Lagap litigation, that settlement agreement was not accompanied by a transfer of value and was conditional upon Lundbeck paying damages to Neolab in the event of an unfavourable judgment in that litigation. After Lundbeck ultimately decided to settle its dispute with Lagap amicably, Neolab still had an interest in obtaining damages by having Lundbeck’s patent declared invalid. In that context, Lundbeck deemed it preferable to settle its dispute with Neolab also, by accepting to pay it the damages incurred in respect of the year when it withdrew from the market, and by committing not to make any patent claims in the event that Neolab entered the market (recital 164 of the contested decision). That latter commitment is therefore crucial, since, contrary to the agreements at issue in the present case, the payment made by Lundbeck was not made in exchange for an exclusion from the market, but was accompanied, on the contrary, by an acceptance of non-infringement and a commitment not to hinder the market entry of Neolab with its generics. |
| 352 | Nasprotno pa je Komisija utemeljeno menila, da je mogoče sklepati, kadar je obrnjeno plačilo povezano z izključitvijo konkurentov s trga ali z omejitvijo spodbud za izvedbo vstopa, da taka omejitev ne izhaja izključno iz ocene strank o moči patentov, ampak je bila dosežena s takim plačilom (točka 604 obrazložitve izpodbijanega sklepa), ki zato pomeni izplačilo konkurentov. | 352 | However, where a reverse payment is combined with an exclusion of competitors from the market or a limitation of the incentives to seek market entry, the Commission rightly took the view that it was possible to consider that such a limitation did not arise exclusively from the parties’ assessments of the strength of the patents but rather was obtained by means of that payment (recital 604 of the contested decision), constituting, therefore, a buying-off of competition. |
| 353 | Velikost obrnjenega plačila namreč lahko kaže na moč ali šibkost patenta kot ga dojemajo stranke sporazumov v času njihove sklenitve, in na to, da proizvajalec originalnih zdravil sprva ni bil prepričan o svojih možnostih za uspeh v sporu. V tem smislu je tudi Supreme Court of the United States (Vrhovno sodišče Združenih držav) menilo, da je znatno obrnjeno plačilo v patentni poravnavi lahko praktični nadomestek za šibkost patenta, ne da bi bilo treba sodišču poglobljeno obravnavati veljavnost tega patenta (glej v tem smislu sodbo Vrhovnega sodišča Združenih držav z dne 17. junija 2013, Federal Trade Commission proti Actavis, 570 U.S. (2013), v nadaljevanju: sodba Actavis). Poleg tega tožeči stranki ob sklicevanju na točko 640 obrazložitve izpodbijanega sklepa priznavata, da večje, kot so po mnenju proizvajalca originalnih zdravil možnosti za to, da bo njegov patent razveljavljen ali da ne bo kršen, in večja, kot bi bila škoda zaradi uspešnega vstopa generikov na trg, več denarja bi bil proizvajalec originalnih zdravil pripravljen plačati generičnim podjetjem za to, da bi se temu tveganju izognil. | 353 | The size of a reverse payment may constitute an indicator of the strength or weakness of a patent, as perceived by the parties to the agreements at the time they were concluded, and of the fact that originator undertaking was not initially convinced of its chances of succeeding in the event of litigation. Similarly, the Supreme Court of the United States has also held that the presence of a significant reverse payment in a patent settlement agreement can provide a workable surrogate for the weakness of a patent, without a court having to carry out a detailed analysis of the validity of that patent (judgment of the Supreme Court of the United States of 17 June 2013 in Federal Trade Commission v. Actavis, 570 U.S. (2013), ‘the Actavis judgment’). Moreover, the applicants, citing recital 640 of the contested decision in their written pleadings, seem to acknowledge that, the higher the originator undertaking estimates the chances of its patent being found invalid or not infringed, and the higher the damage to the originator undertaking resulting from successful generic entry, the more money it will be willing to pay the generic undertakings to avoid that risk. |
| 354 | V zvezi s tem je treba poudariti, da Komisija v izpodbijanem sklepu ni ugotovila, da so vse patentne poravnave z obrnjenimi plačili v nasprotju s členom 101(1) PDEU, ampak samo to, da je na podlagi nesorazmernosti teh plačil v povezavi z drugimi dejavniki – kot je to, da ti zneski, kot kaže, ustrezajo vsaj pričakovanim dobičkom generičnih podjetij ob vstopu na trg, odsotnost določb, ki generičnim podjetjem omogočajo dajanje njihovih proizvodov na trg po poteku sporazumov, ne da bi jih skrbele tožbe družbe Lundbeck zaradi kršitev, ali pa to, da so v teh sporazumih omejitve, ki presegajo obseg patentov družbe Lundbeck – mogoče sklepati, da je cilj spornih sporazumov v obravnavani zadevi omejevanje konkurence v smislu navedene določbe (glej točki 661 in 662 obrazložitve izpodbijanega sklepa). | 354 | It must be noted, in that respect, that the Commission did not find, in the contested decision, that all patent settlement agreements containing reverse payments were contrary to Article 101(1) TFEU; it found only that the disproportionate nature of such payments, combined with several other factors — such as the fact that the amounts of those payments seemed to correspond at least to the profit anticipated by the generic undertakings if they had entered the market, the absence of provisions allowing the generic undertakings to launch their product on the market upon the expiry of the agreement without having to fear infringement actions brought by Lundbeck, or the presence, in those agreements, of restrictions going beyond the scope of Lundbeck’s patents — led to the conclusion that the agreements at issue had as their object the restriction of competition, within the meaning of Article 101(1) TFEU, in the present case (see recitals 661 and 662 of the contested decision). |
| 355 | Zato je treba ugotoviti, da Komisija ni storila napake s tem, da je v izpodbijanem sklepu menila, da sta obstoj obrnjenega plačila in njegova nesorazmernost upoštevna pri dokazovanju, da so bili sporni sporazumi omejitev konkurence „zaradi cilja“ v smislu člena 101(1) PDEU, ker je proizvajalec originalnih zdravil s tem plačilom spodbudil generična podjetja k opustitvi njihovih samostojnih prizadevanj za vstop na trg. | 355 | It must be found, therefore, that the Commission did not err in considering, in the contested decision, that the very existence of reverse payments and the disproportionate nature of those payments were relevant factors in establishing whether the agreements at issue constituted restrictions of competition ‘by object’ for the purpose of Article 101 TFEU in that, by those payments, the originator undertaking provided an incentive to the generic undertakings not to continue their independent efforts to enter the market. |
| 356 | Te ugotovitve ni mogoče ovreči z nobeno trditvijo tožečih strank. | 356 | None of the applicants’ arguments is such as to call that conclusion into question. |
| 357 | Tožeči stranki na prvem mestu trdita, da v izpodbijanem sklepu ni dokazano, da sporni sporazumi ne odražajo ocene strank o moči patentov. V izpodbijanem sklepu naj bi se konkretne določbe spornih sporazumov dobesedno razumele ter naj bi se sklicevalo na ločene navedbe družbe Lundbeck in generičnih podjetij v zvezi z morebitno neveljavnostjo ali neobstojem kršitev patenta za kristalizacijo, in na podlagi tega sklepalo, da se stranki nista dogovorili na podlagi moči patentov. Navedene določbe in navedbe, ki naj bi bile edini pisni dokazi v sklepu, pa naj ne bi dokazovale, da sta stranki dvomili v moč patentov družbe Lundbeck. | 357 | In the first place, the applicants submit that the contested decision does not establish that the agreements at issue did not reflect the parties’ assessment of the strength of the patents. The contested decision refers to a literal reading of specific clauses of the agreements at issue and to isolated statements of Lundbeck and of the generic undertakings concerning the possible invalidity or the possible non-infringement of the crystallisation patent, and concludes that the parties did not reach an agreement on the basis of the strength of the patents. However, those clauses and those statements, which constitute the only documentary evidence in the decision, do not show that the parties were in any doubt as to the strength of Lundbeck’s patents. |
| 358 | Vendar tožeči stranki ne izpodbijata tega, da so plačila po spornih sporazumih pomenila „povračilo za“ zaveze generičnih podjetij in da so bila „povezana“ z zavezami generičnih podjetij, da na trg ne dajo citaloprama, s katerim se kršijo patenti družbe Lundbeck. Ne zanikata ni tega, da bi plačila lahko pomenila dodatno spodbudo za generična podjetja, da se poravnajo. Kljub temu pa po njunem mnenju zgolj povračilo ali zgolj povezava ne dokazuje, da so plačila „zasenčila“ oceno strank v spornih sporazumih o moči patentov, tako da „posledična izključitev s trga ni bila dosežena z močjo patenta, ampak z zneskom prenosa vrednosti“ (točki 604 in 641 obrazložitve izpodbijanega sklepa). | 358 | The applicants do not dispute, however, that the payments provided for in the agreements at issue represented ‘consideration for’ and were ‘related to’ the generic undertakings’ commitments to refrain from launching citalopram that infringed Lundbeck’s patents. Nor do they deny that the payments may have represented an additional incentive for the generic undertakings to find a settlement. Nonetheless, in their submission, a mere ‘consideration’ or ‘relation’ does not prove that the payments ‘overshadowed’ the parties’ assessment of the merits of the patents in such a way that ‘the result of market exclusion [was] achieved not by the strength of the patent, but by the amount of the value transfer’ (recitals 604 and 641 of the contested decision). |
| 359 | Zadostuje ugotovitev, da je taka trditev brezpredmetna, ker temelji na napačnem razumevanju izpodbijanega sklepa. | 359 | It suffices to note that that argument is ineffective, since it is based on an erroneous reading of the contested decision. |
| 360 | Komisija namreč v izpodbijanem sklepu ni ugotovila, da se člen 101(1) PDEU ne uporablja samo za poravnave, ki temeljijo „izključno“ na oceni strank o moči patentov. Nasprotno, menila je, da se ta določba, kadar ob upoštevanju več dejavnikov v zvezi s tem (glej točko 365 zgoraj) ti sporazumi vsebujejo znatna obrnjena plačila, s katerimi se zmanjšuje ali odpravlja vsakršna spodbuda za generična podjetja, da vstopijo na trg v določenem obdobju, ne rešujejo pa osnovnega patentnega spora, uporablja za te sporazume (točka 604 obrazložitve izpodbijanega sklepa). V takem primeru namreč prenos vrednosti nadomešča samostojno oceno strank o moči patentov proizvajalca originalnih zdravil podjetja in oceno njihovih možnosti za uspeh v morebitnem sporu na podlagi teh patentov ali o njihovi veljavnosti (glej točko 353 zgoraj). | 360 | The Commission did not consider, in the contested decision, that only settlements based ‘exclusively’ on the parties’ assessment of the strength of the patents were outside the scope of Article 101(1) TFEU. Rather, it took the view, taking into account a series of factors in that respect (see paragraph 354 above), that where such agreements contain significant reverse payments, which reduce or eliminate any incentive for the generic undertakings to enter the market for a certain period, without, however, resolving the underlying patent dispute, those agreements fall within the scope of Article 101(1) TFEU (recital 604 of the contested decision). In such cases, the transfer of value replaces the autonomous assessment, by the parties, of the strength of the originator undertaking’s patents and the assessment of their chances of succeeding in potential litigation based on those patents or concerning their validity (see paragraph 353 above). |
| 361 | V obravnavani zadevi pa je treba spomniti – tako kot je to storila Komisija – prvič, da se stranke spornih sporazumov niso strinjale o tem, ali so bili patenti družbe Lundbeck dovolj trdni za preprečitev vstopa generičnega citaloprama na trg, zato ti patenti niso mogli biti odločilni pri odločitvi generičnih podjetij, da ne vstopijo na trg. Plačila so tako služila kot sprožilec („dealclincher“) za dogovor in so bila ključna za to, da se je generična podjetja prepričalo, naj si prenehajo prizadevati za vstop na trg. | 361 | First, in the present case, it must be recalled, as the Commission submits, that the parties to the agreements at issue were in dispute over whether Lundbeck’s patents were sufficiently strong to prevent the market entry of generic citalopram and that those patents cannot have constituted the decisive basis of the generic undertakings’ commitment not to enter the market. The payments thus served as a ‘deal clincher’ and were decisive in convincing the generic undertakings to abandon their efforts to enter the market. |
| 362 | Drugič, tožeči stranki ne izpodbijata tega, da so lahko bili zneski, ki sta jih izplačali generičnim podjetjem, izračunani tako, da se je kot podlaga upošteval dobiček ali promet, ki so ga zadnjenavedena pričakovala med trajanjem spornih sporazumov, če bi bila vstopila na trg, kar je pomemben dejavnik v zvezi s tem. Tožeči stranki sta na obravnavi navedli, da so tak izračun lahko opravila samo generična podjetja in ne oni sami, kar pa ne vpliva na navedeno ugotovitev. | 362 | Secondly, the applicants do not dispute that the amounts which they paid to the generic undertakings may have been calculated by taking into consideration the profit or turnover which those undertakings expected to make during the term of the agreements at issue if they had entered the market, which is a significant factor in that respect. At the hearing, the applicants submitted that such a calculation could only have been made by the generic undertakings, and not by themselves, which in no way changes that finding. |
| 363 | Tretjič, dokazi v zvezi z obdobjem pred sklenitvijo spornih sporazumov kažejo na to, da so generična podjetja opravila znatne napore za pripravo svojega vstopa na trg, in da se niso nameravala odpovedati tem naporom zaradi patentov družbe Lundbeck. Res je, da je obstajala negotovost glede tega, ali bi pristojno sodišče njihove proizvode spoznalo za ponaredke. Vendar je iz izpodbijanega sklepa razvidno, da so imela generična podjetja resnične možnosti za uspeh v primeru spora (glej točko 122 zgoraj ter točki 75 in 76 izpodbijanega sklepa). Zato sta tožeči stranki s sklenitvijo spornih sporazumov to negotovost zamenjali za gotovost, da generična podjetja ne bodo vstopila na trg, in sicer z znatnimi obrnjenimi plačili (točka 604 obrazložitve izpodbijanega sklepa), s čimer sta odpravili vsakršno – celo potencialno – konkurenco na trgu med njihovim trajanjem. | 363 | Thirdly, the evidence relating to the period preceding the conclusion of the agreements at issue shows that the generic undertakings had made considerable efforts to prepare for their market entry and that they did not intend to desist from those efforts on account of Lundbeck’s patents. It is true that there was uncertainty as to whether their products would have eventually been declared infringing by a competent court. The contested decision demonstrates, however, that the generic undertakings had a real chance of succeeding in the event of litigation (see paragraph 122 above and recitals 75 and 76 of the contested decision). Accordingly, by concluding the agreements at issue, the applicants exchanged that uncertainty for the certainty that the generic undertakings would not enter the market, by means of significant reverse payments (recital 604 of the contested decision), thus eliminating all competition, even potential, on the market, during the term of those agreements. |
| 364 | Na drugem mestu, tožeči stranki menita, da v izpodbijanem sklepu ni dokazano, kako obstoj prenosa vrednosti kaže na to, da se omejitve ne ujemajo z oceno strank o moči zadevnih patentov. Menita, da izpodbijani sklep temelji na obstoju njunih plačil generičnim podjetjem, na podlagi česar se domneva, da so stranke dvomile v veljavnost in/ali kršitev upoštevnih patentov. Napačna naj bi bila trditev, da „večja, kot je po mnenju proizvajalca originalnih zdravil možnost, da bo njegov patent razglašen za neveljaven ali da ne bo kršen […], več denarja je pripravljen plačati generičnemu proizvajalcu za preprečitev tega tveganja“ (točka 640 obrazložitve izpodbijanega sklepa). Zato naj bi se z izpodbijanim sklepom kršila veljavna dokazna pravila, ki Komisiji nalagajo, da ovrže kakršna koli pojasnila prenosa vrednosti, ki niso protikonkurenčni dogovori. | 364 | In the second place, the applicants maintain that the contested decision fails to show how the existence of a value transfer indicates that the restrictions did not match the parties’ assessment of the strength of the patents at issue. In their submission, the contested decision relies on the fact that the applicants made payments to the generic undertakings as a basis for the presumption that the parties had doubts as to the validity or the infringement of the relevant patents. It is incorrect to assert that ‘the higher the originator undertaking estimates the chance of its patent being found invalid or not infringed ..., the more money it will be willing to pay the generic undertaking to avoid that risk’ (recital 640 of the contested decision). The contested decision therefore breaches the applicable evidential rules, under which the Commission is required to rebut all explanations for the value transfers other than anticompetitive collusion. |
| 365 | Tožeči stranki navajata, da je ekonomsko domnevo, kakršna je tista, na katero naj bi se v izpodbijanem sklepu opirala Komisija, mogoče upoštevati, samo če temelji na trdni izkustveni in teoretični podlagi, in da lahko Komisija uveljavlja nezadostno jasno domnevo, samo če dokaže, da gre za edino smiselno razlago. To pravilo bi bilo treba po analogiji uporabiti za domnevo, da obrnjeno plačilo iz poravnave pomeni, da so stranke dvomile v moč upoštevnega patenta. | 365 | The applicants claim that an economic presumption, such as that on which the Commission relies in the contested decision, can be accepted only if it is based on robust empirical and theoretical foundations, and that the Commission can rely on an insufficiently clear presumption only if it has proved that that was the only plausible explanation. This standard must apply by analogy to the inference that a reverse payment in a settlement implies that the parties lack confidence in the strength of the relevant patent. |
| 366 | V zvezi s tem je treba v skladu s sodno prakso, navedeno zgoraj v točkah od 105 do 112, ugotoviti, da se je Komisija v izpodbijanem sklepu oprla na vse tiste dokaze, ki dokazujejo, da je bila višina obrnjenih plačil generičnim podjetjem tista, ki jih je spodbudila k privolitvi v omejitve njihovega ravnanja, in ne obstoj patentiranih postopkov družbe Lundbeck ali celo želja po preprečitvi stroškov v zvezi z morebitnim sporom (glej zlasti točki 255 in 748 obrazložitve izpodbijanega sklepa ter točki 354 in 363 zgoraj). V izpodbijanem sklepu je na primer v zvezi s podjetjem Merck (GUK) dokazano, da so ti zneski ustrezali donosu, ki si ga je obetalo z vstopom na trg, ne da bi se mu bilo treba še naprej prizadevati za to in prevzemati tveganja takega vstopa (točke 350, 809 in 862 obrazložitve izpodbijanega sklepa). Podobni preudarki so v točkah 398, 460, 1071 in 1157 obrazložitve izpodbijanega sklepa v zvezi s podjetji Arrow, Alpharma in Ranbaxy. | 366 | It must be pointed out, in that respect, that, in accordance with the case-law cited in paragraphs 105 to 112 above, in the present case, the Commission relied on a body of evidence in the contested decision to demonstrate that it is principally the size of the reverse payments to the generic undertakings which induced those undertakings to accept the limitations governing their behaviour and not the existence of Lundbeck’s process patents or even the desire to avoid the expenses linked to potential litigation (see inter alia recitals 255 and 748 of the contested decision and paragraphs 354 and 363 above). As regards Merck (GUK), for example, the contested decision shows that those amounts corresponded to the profits that it expected to make by entering the market, without it having to continue its efforts and bear the risks of such an entry (recitals 350, 809 and 862 of the contested decision). Similar considerations are set out in recitals 398, 460, 1071 and 1157 of the contested decision as regards Arrow, Alpharma and Ranbaxy. |
| 367 | Tožeči stranki se poleg tega sklicujeta na točko 640 obrazložitve izpodbijanega sklepa (točka 364 zgoraj), v kateri je Komisija ugotovila, da je višina obrnjenega plačila pogosto obratno sorazmerna s tveganjem – kakor ga dojema proizvajalec originalnih zdravil – doseganja sodbe, s katero bi se ugotovila neveljavnost njegovega patenta ali to, da generični proizvodi niso ponaredki, in tudi s škodo, ki bi mu nastala zaradi vstopa teh proizvodov na trg. Tožeči stranki ne izpodbijata niti tega, da so obrnjena plačila pomenila povračilo za zaveze generičnih podjetij, da ne vstopijo na trg z generičnim citalopramom, za katerega sta menili, da se z njim kršijo njuni patenti, niti tega, da bi ta plačila lahko dodatno spodbudila generična podjetja k sklenitvi spornih sporazumov. | 367 | In addition, in their pleadings the applicants themselves quote recital 640 of the contested decision (paragraph 353 above), where the Commission found that the size of a reverse payment is often linked to the risk, as perceived by the originator undertaking, of a judgment finding its patent invalid or the generic products non-infringing, as well as the damage to the originator undertaking resulting from the market entry of those products. The applicants also do not dispute that the reverse payments represent consideration for the commitments made by the generic undertakings to abstain from entering the market with generic citalopram which the applicants considered to infringe their patents, nor that those payments could have represented an additional incentive to conclude the agreements at issue. |
| 368 | Sicer pa dokazi iz časa spornih sporazumov kažejo na to, da sta tožeči stranki nameravali uporabiti „veliko količino [USD]“ za izključitev generikov s trga (točka 131 obrazložitve izpodbijanega sklepa), čeprav sta dvomili v veljavnost njunih patentov in v njune možnosti uspeha v primeru sodnega spora (točka 149 obrazložitve izpodbijanega sklepa in točka 126 zgoraj). | 368 | In addition, the evidence contemporaneous to the agreements at issue shows that the applicants intended to use ‘a large pile of [USD]’ to exclude generics from the market (recital 131 of the contested decision) whereas they doubted the validity of their patents and their chances of succeeding in proceedings before a court (recital 149 of the contested decision and paragraph 126 above). |
| 369 | Vsekakor pa Komisiji pri dokazovanju obstoja kršitve zaradi cilja v obravnavani zadevi ni bilo treba neizpodbitno dokazati, da sta tožeči stranki dvomili v veljavnost njunih patentov, ker dokazi v izpodbijanem sklepu dokazujejo, da so bila generična podjetja prepričana v svoje možnosti vstopa na trg v dovolj kratkem roku, bodisi z izpodbijanjem trditev tožečih strank o kršenju bodisi z izpodbijanjem veljavnosti njunih patentov v primeru spora (glej prvi tožbeni razlog zgoraj). Pomembno je torej to, da je v času sklenitve spornih sporazumov obstajala negotovost v zvezi z možnostjo generičnih podjetij za vstop na trg, ne da bi se izpostavila prepovedim ali tožbam zaradi kršitev, ali za uspešno izpodbijanje veljavnosti patentov tožečih strank, in da so ti sporazumi to negotovost z visokimi obrnjenimi plačili spremenili v gotovost, da generična podjetja ne bodo vstopila na trg med trajanjem spornih sporazumov (točki 337 in 372 zgoraj). | 369 | In any event, the Commission was not required to demonstrate irrefutably that the applicants doubted the validity of their patents in order to establish the existence of an infringement by object in the present case, since the evidence set out in the contested decision shows that the generic undertakings were confident of their chances of being able to enter the market within a sufficiently short period, either by overcoming the applicants’ infringement allegations, or by challenging the validity of their patents, in the event of a dispute (see the first plea in law above). What matters, therefore, is that there was uncertainty, at the time the agreements at issue were concluded, as to the possibility, for the generic undertakings, of entering the market without being subject to injunctions or infringement actions, or of successfully challenging the validity of the applicants’ patents, and that those agreements had replaced that uncertainty, by means of significant reverse payments, with the certainty that the generic undertakings would not enter the market during the term of the agreements at issue (paragraphs 336 and 363 above). |
| 370 | Na tretjem mestu, tožeči stranki menita, da v izpodbijanem sklepu niso ovržena druga pojasnila prenosov vrednosti in opozarja na to, da sta v njunem odgovoru na obvestilo o ugotovitvah o možnih kršitvah navedli, da zadevna plačila kažejo na pritisk generičnih podjetij nanju zaradi asimetrije med njunimi in njihovimi tveganji. Tožeči stranki naj bi namreč tvegali znatno in nepopravljivo škodo zaradi kršitev generičnih podjetij, medtem ko naj bi bilo tveganje zadnjenavedenih majhno, celo neobstoječe. Ta asimetrija naj bi pojasnjevala, zakaj sta tožeči stranki v spornih sporazumih privolili v obrnjena plačila v njuno breme. Ta problem „izsiljevanja“ naj bi se kazal v vsakem od sporazumov, opredeljenih v obvestilu o ugotovitvah o možnih kršitvah. | 370 | In the third place, the applicants contend that the contested decision does not rebut the alternative explanations for the value transfers, and point out that in their reply to the statement of objections they claimed that the payments at issue demonstrated the pressure applied by the generic undertakings because of the asymmetry of the risks borne by the applicants and those borne by the generic undertakings. The applicants were at risk of sustaining considerable and irreversible damage as a result of the infringement by the generic undertakings, whereas the latter undertakings faced little or no risk. That asymmetry explains why the applicants agreed to make the reverse payments specified in the agreements at issue. That ‘hold-up’ problem is apparent in each of the agreements identified in the statement of objections. |
| 371 | V izpodbijanem sklepu, zlasti v točki 644 obrazložitve, naj bi bil obstoj navedene asimetrije tveganj potrjen z navedbo, da bi bil donos, ki bi ga generično podjetje ustvarilo z vstopom na trg, manjši ali celo precej manjši od izgub, ki bi jih proizvajalec originalnih zdravil verjetno utrpel ob vstopu generičnih zdravil na trg. Poleg tega naj bi bile tudi odškodnine, na katerih plačilo bi lahko bila obsojena generična podjetja, samo delček potencialne škode, ki bi originalnemu podjetju nastala zaradi nezakonitega vstopa na trg. Generičnim podjetjem naj namreč v nekaterih primerih ne bi bilo treba nadomestiti nobene nepopravljive škode, povzročene z njihovim nezakonitim vstopom. Sicer pa bi se lahko višina cen ali nadomestil, ki jih določijo javni organi, samodejno znižala od vstopa generičnih različic na trg, ne glede na to, ali se z njimi kršijo veljavni patenti ali ne. Tudi stroški več patentnih sporov bi bili izjemno visoki. | 371 | According to the applicants, the contested decision, particularly in recital 644, recognises that asymmetry of risks, when it states that the profit that a generic undertaking could make from entering the market would be lower, indeed considerably lower, than the losses which the originator undertaking would be likely to make if generic medicinal products entered the market. In addition, the damages which the generic undertakings might be ordered to pay would represent only a fraction of the potential damage that would probably be caused to the originator undertaking by the unlawful entry of the generic undertakings. In some cases the generic undertakings would not have to pay compensation for any of the irreversible damage caused by their unlawful entry. Furthermore, the price levels or reimbursement levels, set by the public authorities, might be automatically lowered upon the entry of generic versions to the market, independently of whether or not those versions infringe valid patents. The costs incurred in litigating multiple patent disputes would also be extremely high. |
| 372 | Generična podjetja naj bi torej izkoristila to asimetrijo tveganj z zavajanjem, da se pripravljajo na prodajo svojih ponarejenih proizvodov, dala pa jim je tudi potrebno moč, da izsilijo plačilo od družbe Lundbeck. Tudi v ekonomski literaturi in izpodbijanem sklepu, zlasti točki 640 obrazložitve, naj bi bilo potrjeno, da bolj kot proizvajalec originalnih zdravil ocenjuje, da bo škoda zaradi vstopa generičnih podjetij na trg visoka, več denarja je pripravljen plačati tem podjetjem za preprečitev tega tveganja. | 372 | It is therefore, according to the applicants, that asymmetry of risks which the generic undertakings exploited by giving the misleading impression that they were about to sell their infringing products, and which gave them the necessary power to extract payments from Lundbeck. Both the economic literature and the contested decision, in particular in recital 640, also recognise that the greater the damage the originator undertaking estimates it will suffer as a result of market entry by generic undertakings, the more money it may be willing to pay those undertakings in order to avoid such a risk. |
| 373 | Zato Komisija po mnenju tožečih strank v izpodbijanem sklepu napačno domneva, da ocena generičnega podjetja o moči patenta določa njegovo motivacijo za dajanje na trg določenega zdravila, čeprav je ta ocena samo eno od upoštevnih meril za odločitev o dajanju na trg in mogoče ni upoštevna, kadar generična podjetja pričakujejo dobiček iz kršitve. | 373 | Accordingly, in the applicants’ submission, the Commission, in the contested decision, errs when it presumes that a generic undertaking’s assessment of the strength of a patent is the sole factor that determines its incentive to launch a medicinal product, whereas such an assessment is only one of a number of criteria of relevance to the decision to launch and may not be relevant when the generic undertakings expect to make a profit from an infringement. |
| 374 | Zato naj se v izpodbijanem sklepu – brez povezave med plačili in subjektivnim dojemanjem strank spornih sporazumov o njihovih patentnih zahtevkih – ne bi mogla utemeljiti ugotovitev, da je plačilo vodilo generična podjetja v privolitev v omejitve, v katere ne bi privolila zgolj na podlagi njihove ocene moči patentov. Zato naj bi po mnenju tožečih strank odpadla prva vzročna zveza, na kateri temelji teorija v izpodbijanem sklepu, ugotovitev, da se s spornimi sporazumi krši člen 101(1) PDEU, pa naj bi bila brez podlage. | 374 | Consequently, in the absence of a link between the payments and the subjective perceptions of the parties to the agreements at issue of their respective patent claims, the contested decision cannot substantiate the finding that the payment induced the generic undertakings to accept limitations that they would not have accepted on the sole basis of their assessment of the strength of the patents. According to the applicants therefore, the first causal link on which the contested decision bases its theory falls, and the conclusion that the agreements at issue infringe Article 101(1) TFEU is baseless. |
| 375 | Tudi intervenient meni, da bi morala Komisija dokazati, da ni druge zakonite razlage prenosa vrednosti ob upoštevanju, prvič, tveganja nepopravljive škode za imetnika patentov v primeru nezakonitega vstopa generikov na trg, drugič, možnosti doseganja ustreznega nadomestila z odškodnino ali možnost doseganja začasnih odredb, in tretjič, stroškov v zvezi s sprožitvijo več postopkov pri različnih sodiščih, vključno s tveganjem različnih rezultatov pri različnih sodiščih. Komisija bi morala zato dokazati, zakaj obstoj prenosa vrednosti spremeni zakonito poravnavo v protikonkurenčni horizontalni sporazum. | 375 | The intervener also maintains that the Commission ought to have shown that there was no other lawful explanation for the value transfer, taking into account, first, the risk of irreparable damage for the patent-holder in the event of the generics’ unlawful entry to the market; secondly, the likelihood of being able to obtain adequate compensation by way of damages or being able to obtain interim relief; thirdly, the costs associated with bringing proceedings before multiple courts, including the risk of different courts arriving at different outcomes. The Commission is therefore required to show why the existence of a value transfer transforms a lawful settlement agreement into an anticompetitive horizontal agreement. |
| 376 | Ugotoviti je treba, da je Komisija v nasprotju z navedbami tožečih strank v izpodbijanem sklepu zavrnila druga pojasnila tožečih strank o obstoju nasprotnih plačil v spornih sporazumih, med drugim tista v zvezi s „teorijo blefiranja“ in asimetrijo tveganj. | 376 | It must be pointed out that, contrary to the applicants’ assertions, the Commission refuted, in the contested decision, the other explanations put forward by the applicants concerning the existence of reverse payments in the agreements at issue, in particular those relating to the ‘bluff theory’ and the asymmetry of risks. |
| 377 | Komisija je tako v izpodbijanem sklepu potrdila, da je za proizvajalca originalnih zdravil lahko poslovno smiselno, da plača generičnim podjetjem in s tem prepreči njihov vstop na trg, ob upoštevanju sredstev, ki jih lahko izgubi ob takem vstopu. Poleg tega ta sredstva verjetno presegajo donos, ki bi ga generična podjetja ustvarila pri takem vstopu, če njihovi proizvodi ne bi bili spoznani za ponaredke ali če bi dosegla neveljavnost zadevnih patentov. Vendar je Komisija menila, da bi v takem primeru izgubili potrošniki, ker bi bili prikrajšani za možnost kupovanja po nižjih cenah zaradi vstopa generikov na trg (točka 640 obrazložitve izpodbijanega sklepa). | 377 | The Commission thus recognised, in the contested decision, that it could make sense, from a commercial perspective, for the originator undertaking to pay the generic undertakings in order to prevent their market entry, in view of the amounts that it could lose in the event of such entry. In addition, those amounts would probably exceed the profits that the generic undertakings would have made in the event of such entry, if their products were not considered to be infringing or if they succeeded in having the patents concerned invalidated. In such a case, however, the Commission considered that consumers would be worse off, since they would be deprived of the possibility of paying lower prices due to the market entry of generics (recital 640 of the contested decision). |
| 378 | Tožeči stranki v zvezi s tem navajata, da bi bila v nekaterih primerih tveganja generičnih podjetij v zvezi z vstopom na trg zelo majhna ali celo neobstoječa, in ta bi se lahko izognila začasnim odredbam ali odškodninam v primeru nezakonitega vstopa, zlasti z umetnimi mehanizmi kot je prenos dobička med različnimi pravnimi subjekti. Poleg tega naj bi bilo v izpodbijanem sklepu potrjeno, da bi bile odškodnine, ki bi jim lahko bile naložene, pogosto precej nižje od škode, ki bi jo utrpel proizvajalec originalnih zdravil ob nezakonitem vstopu na trg zaradi negativne spirale cen, ki bi jo povzročil tak vstop (točki 93 in 645 obrazložitve izpodbijanega sklepa). | 378 | The applicants submit in that respect that, in certain cases, the risks relating to market entry, if any, are very small for generic undertakings, which could avoid injunctions precluding that market entry or orders to pay damages in the event of unlawful entry, in particular by means of artificial arrangements such as the transfer of profits between various legal entities. Moreover, the contested decision acknowledges that the damages that they could be ordered to pay will often be substantially lower than the damage suffered by the originator undertaking in the event of unlawful market entry, because of the downward spiral of prices caused by such entry (recitals 93 and 645 of the contested decision). |
| 379 | Res je, da je mogoče z asimetrijo tveganj generičnih podjetij in proizvajalca originalnih zdravil deloma pojasniti razloge, iz katerih je zadnjenavedeni plačal znatna obrnjena plačila, da bi se izognil kakršnemu koli – celo minimalnemu – tveganju, da bi generična podjetja lahko vstopila na trg. To je še posebej tako, kadar je s patentom zaščiteno zdravilo – kot v obravnavani zadevi Cipramil – najpomembnejši proizvod proizvajalca originalnih zdravil, ki je temelj njegovega prometa (točki 26 in 120 obrazložitve izpodbijanega sklepa). | 379 | It is true that the asymmetry of the risks faced by the generic undertakings and the originator undertaking can partly explain why the latter may decide to grant significant reverse payments in order to avoid any risk, even small, that the generics might enter the market. That is particularly so where the patented medicinal product, like Cipramil in the present case, is the flagship product of the originator undertaking, representing most of its turnover (recitals 26 and 120 of the contested decision). |
| 380 | Spomniti pa je treba, da to, da je lahko protikonkurenčno ravnanje stroškovno najučinkovitejša ali vsaj najmanj tvegana rešitev za podjetje, nikakor ne izključuje uporabe člena 101(1) PDEU (glej v tem smislu sodbi z dne 8. julija 2004, Corus UK/Komisija, T‑48/00, ZOdl., EU:T:2004:219, točka 73, in z dne 8. julija 2004, Dalmine/Komisija,T‑50/00, ZOdl., EU:T:2004:220, točka 211), zlasti kadar gre za plačilo dejanskih ali potencialnih konkurentov za to, da ostanejo zunaj trga in da se z njimi razdeli dobiček zaradi odsotnosti generičnih zdravil s tega trga na škodo potrošnikov, kot se je zgodilo v obravnavani zadevi. | 380 | It must be recalled, however, that the fact that the adoption of anticompetitive behaviour may be the most cost-effective or least risky course of action for an undertaking in no way excludes the application of Article 101 TFEU (see, to that effect, judgments of 8 July 2004 in Corus UK v Commission, T‑48/00, ECR, EU:T:2004:219, paragraph 73, and 8 July 2004 in Dalmine v Commission, T‑50/00, ECR, EU:T:2004:220, paragraph 211), particularly if that behaviour consists in paying actual or potential competitors not to enter the market and sharing with those competitors the profits resulting from the absence of generic medicinal products on that market, to the detriment of consumers, as in the present case. |
| 381 | Po mnenju tožečih strank naj bi asimetrija tveganj generičnim podjetjem omogočila, da so z „blefiranjem“ od tožečih strank pridobila precejšnja denarna sredstva, s pretvarjanjem, da se pripravljajo na vstop na trg z neponarejenimi proizvodi. | 381 | According to the applicants, the asymmetry of risks allowed the generic undertakings to ‘bluff’ the applicants in order to obtain significant amounts of money, by pretending that they were preparing to enter the market with non-infringing products. |
| 382 | Vendar se s tem zgolj potrjuje teza Komisije, da je v času sklenitve spornih sporazumov obstajala velika negotovost glede morebitnih patentnih sporov in da je bila ta negotovost odpravljena in nadomeščena z gotovostjo, da generična podjetja med trajanjem teh sporazumov ne bodo vstopila na trg. | 382 | However, that merely confirms the Commission’s theory that there was significant uncertainty, at the time the agreements at issue were concluded, as regards the outcome of the potential patent litigation, and that that uncertainty was eliminated and replaced by the certainty that the generic undertakings would not enter the market during the term of those agreements. |
| 383 | Sicer pa to, da je lahko nasprotno plačilo edini način za doseganje sporazuma s „preseganjem razlik“ med strankama tega sporazuma, ne pomeni, da je tako plačilo zakonit način dogovarjanja, ali da se za tak sporazum ne uporablja pravo konkurence, še posebej, kadar se zdi, da je višina tega plačila povezana s pričakovanim donosom generičnih podjetij ob vstopu na trg, kadar sporazum ne omogoča rešitve osnovnega patentnega spora med strankami in kadar ta vsebuje omejitve, ki presegajo obseg patenta proizvajalca originalnih zdravil (točka 365 zgoraj ter točki 661 in 662 obrazložitve izpodbijanega sklepa). | 383 | Furthermore, the fact that a reverse payment may constitute the only means of reaching an agreement by ‘bridging the gap’ between the parties to that agreement, does not mean that such a payment constitutes a legitimate means of reaching such an agreement or that that agreement is exempt from the application of competition law, in particular in circumstances where (i) the amount of that payment appears to be linked to the profits expected by those generic undertakings if they had entered the market, (ii) the agreement does not enable the resolution of the underlying patent dispute and (iii) the agreement contains restrictions going beyond the scope of the originator undertaking’s patents (see paragraph 354 above and recitals 661 and 662 of the contested decision). |
| 384 | Poleg tega bi tožeči stranki, če bi bili tako prepričani o veljavnosti svojih patentov in glede na to, da bi se s proizvodi, ki so jih nameravala tržiti generična podjetja, ti kršili, pri pristojnih nacionalnih sodiščih lahko dosegli odredbe o prepovedi takega vstopa ali pa – ob nezakonitem vstopu generičnih podjetij – da bi ta podjetja plačala odškodnine. Tako kot v primeru družbe Neolab (točka 350 zgoraj) bi lahko sklenili tudi poravnavo z namenom rešitve osnovnega patentnega spora, ne da bi bile morebitne dosežene omejitve poslovne samostojnosti generičnih podjetij po takem sporazumu motivirane z obrnjenim plačilom. | 384 | In addition, if the applicants were so convinced of the validity of their patents, and of the fact that the products that the generic undertakings intended to sell infringed them, they could have obtained orders to prevent market entry before the competent national courts, or, in the event that the generic undertakings unlawfully entered the market, obtained damages from them. They could also, as in Neolab’s case (paragraph 350 above), reach a settlement with the genuine purpose of resolving the underlying patent dispute, without the limitations on the commercial autonomy of the generic undertakings potentially obtained under such an agreement being motivated by a reverse payment. |
| 385 | Čeprav je možno – kot priznava Komisija – da bi proizvajalcu originalnih zdravil ob nezakonitem vstopu generičnih podjetij na trg nastala nepopravljiva škoda zaradi nepovratnega znižanja cen, ki bi ga povzročil tak vstop, pa je znižanje reguliranih cen po poteku patenta za AFU značilno za farmacevtske trge, s katerim sta tožeči stranki seznanjeni in je torej običajno poslovno tveganje, ki ne more upravičiti protikonkurenčnih sporazumov. Sicer pa taka znižanja cen zaradi posega regulatorja po poteku patenta za AFU ponazarjajo ravnovesje, ki so ga države članice vzpostavile med varstvom patentov proizvajalca originalnih zdravil na eni strani ter prihranki državnih proračunov in potrošnikov zaradi vstopa generikov na trg in posledic konkurence na drugi. | 385 | Although it is possible, as the Commission acknowledges, that the originator undertaking may have suffered irreparable harm in the event of unlawful entry of the generic undertakings to the market, as a result of the irreversible price falls that such entry would have brought about, regulatory price cuts following the expiry of an API patent are a characteristic of pharmaceutical markets known to the applicants and therefore constitute a normal commercial risk which cannot justify the conclusion of anticompetitive agreements. Furthermore, such price cuts resulting from a regulatory intervention, in a context where the API patent has already expired, illustrate the balance which the Member States have struck between the protection afforded to the patent of the originator undertaking, on the one hand, and the savings for State budgets and for consumers achieved by the entry of generics to the market and the effects of competition, on the other. |
| 386 | Zato bi strinjanje s tezo tožečih strank v zvezi z asimetrijo tveganj v bistvu pomenilo sklepanje, da sta se s sklenitvijo sporazumov, kakršni so sporni sporazumi z generičnimi podjetji, lahko zaščitili pred nepovratnim znižanjem cen, ki ga po njunih lastnih navedbah ni bilo mogoče preprečiti, tudi če bi uspeli v tožbah zaradi kršitev pred nacionalnimi sodišči. S sklenitvijo teh sporazumov bi torej lahko ohranili višje cene njunih proizvodov v škodo potrošnikov in zdravstvenih proračunov držav, čeprav tega ne bi bilo mogoče doseči, če bi nacionalna sodišča potrdila veljavnost njunih patentov in bi bili proizvodi generičnih podjetij spoznani za ponaredke. To bi bilo očitno v nasprotju s cilji določb Pogodbe o konkurenci, ki so med drugim namenjene varstvu potrošnikov pred neupravičenim zvišanjem cen zaradi dogovora med konkurenti (glej v tem smislu sodbi z dne 19. marca 2015, Dole Food in Dole Fresh Fruit Europe/Komisija, C‑286/13 P, ZOdl., EU:C:2015:184, točka 115 in navedena sodna praksa, in z dne 9. julija 2015, InnoLux/Komisija, C‑231/14 P, ZOdl., EU:C:2015:451, točka 61). Nobenega razloga ni za sklepanje, da bi bil tak dogovor v obravnavani zadevi zakonit, z izgovorom da so bili nekateri patentirani postopki sporni, če obranjenje teh patentov pred nacionalnimi sodišči niti po najugodnejšem scenariju za tožeči stranki ne bi vodila do enakih negativnih posledic za konkurenco in še posebej za potrošnike. | 386 | Accordingly, to accept the applicants’ argument concerning the asymmetry of risks would amount, ultimately, to considering that they could — by concluding agreements such as the agreements at issue with the generic undertakings — protect themselves against an irreversible price fall which, according to their own assertions, could not have been avoided even if they had been successful in infringement actions brought before the national courts. They could therefore, by concluding such agreements, maintain higher prices for their products, to the detriment of consumers and the healthcare budgets of States, even though such an outcome could not have been obtained if the national courts had confirmed the validity of their patents and the products of the generic undertakings had been held to be infringing. Such an outcome would be manifestly contrary to the objectives of the treaty provisions on competition, which are intended inter alia to protect consumers from unjustified price increases resulting from collusion between competitors (see, to that effect, judgments of 19 March 2015 in Dole Food and Dole Fresh Fruit Europe v Commission, C‑286/13 P, ECR, EU:C:2015:184, paragraph 115 and the case-law cited, and 9 July 2015 in InnoLux v Commission, C‑231/14 P, ECR, EU:C:2015:451, paragraph 61). There is no reason to suppose that such collusion would be lawful in the present case, under the pretext that certain process patents were in dispute, when the defence of those patents before the national courts could not, even in the most favourable scenario for the applicants, have led to the same negative consequences for competition and, in particular, for consumers. |
| 387 | Ni namreč mogoče sprejeti, da podjetja poskušajo omiliti učinke pravnih pravil, ki jih štejejo za pretirano neugodne, s sklenitvijo omejevalnih sporazumov, katerih cilj je odprava teh neugodnosti, saj naj bi ta pravila ustvarjala neravnotežje v njihovo škodo (glej sodbo z dne 27. julija 2005, Brasserie nationale in drugi/Komisija, od T‑49/02 do T‑51/02, ZOdl., EU:T:2005:298, točka 81 in navedena sodna praksa). | 387 | It should be recalled that it is indeed unacceptable for undertakings to attempt to mitigate the effects of legal rules which they consider excessively unfavourable by entering into restrictive arrangements intended to offset those disadvantages on the pretext that those rules have created an imbalance detrimental to them (see judgment of 27 July 2005 in Brasserie nationale and Others v Commission, T‑49/02 to T‑51/02, ECR, EU:T:2005:298, paragraph 81 and the case-law cited). |
| 388 | Nazadnje, v zvezi s trditvijo tožečih strank – ki ju podpira intervenient – da sporni sporazumi omogočajo preprečitev znatnih stroškov v zvezi s sodnimi postopki v različnih državah članicah in tveganje različnih odločitev v teh sodnih postopkih pri več sodiščih, je treba najprej ugotoviti, da večina spornih sporazumov nikjer konkretno ne omenja stroškov sodnih postopkov, ki bi se preprečili, niti nikakršne ocene teh stroškov. Poleg tega tožeči stranki nista pojasnili načina, kako so bila izračunana obrnjena plačila, razen da so posledica njunih pogajanj z generičnimi podjetji, v izpodbijanem sklepu pa je več dokazov, ki kažejo na to, da so ti zneski bolj ali manj ustrezali pričakovanim donosom generičnih podjetij v primeru vstopa na trg ali odškodninam, ki bi jih lahko dosegla, če bi uspela v sodnih postopkih zoper družbo Lundbeck (glej zlasti točke 398, 460, 809, 862, 1071 in 1157 obrazložitve izpodbijanega sklepa). | 388 | Lastly, inasmuch as the applicants, supported by the intervener, argue that the agreements at issue would have allowed the avoidance of significant costs linked to litigation in various Member States, as well as the risk of conflicting decisions resulting from such litigation before multiple courts, it must be pointed out, first of all, that most of the agreements at issue contain no specific reference to the costs of the litigation that would be avoided, nor the least estimate of those costs. Furthermore, the applicants have not provided any explanation regarding the manner in which the amounts of the reverse payments were calculated, except that they resulted from their negotiations with the generic undertakings, whereas the contested decision contains numerous pieces of evidence showing that those amounts broadly corresponded to the profits expected by the generic undertakings if they had entered the market or to the damages that they might have obtained if they had succeeded in litigation against Lundbeck (see, inter alia, recitals 398, 460, 809, 862, 1071 and 1157 of the contested decision). |
| 389 | Vsekakor pa je v nasprotju z zatrjevanjem tožečih strank malo verjetno, da bi bili stroški v zvezi z morebitnimi sodnimi postopki v različnih državah EGP višji od plačil, ki so jih generična podjetja prejela v skladu s spornimi sporazumi v obravnavani zadevi in so znašala več milijonov eurov. Ni namreč pogosto, da farmacevtska podjetja sprožijo sodne postopke v vseh državah članicah hkrati. Kot kaže primer družbe Lagap v Združenem kraljestvu (točka 63 obrazložitve izpodbijanega sklepa), se načeloma osredotočijo na nekaj testnih postopkov in ne sprožajo več postopkov pri različnih sodiščih, če gre za enaka vprašanja. V primeru družbe Lagap pa so se tožeče stranke nazadnje odločile poravnati, da so se izognile porazu, ki bi bil uporabljen zoper njih pred drugimi sodišči (točka 160 obrazložitve izpodbijanega sklepa). | 389 | In any event, contrary to the applicants’ assertions, it is unlikely that the costs relating to any litigation in the various EEA countries would have been greater than the payments obtained by the generic undertakings under the agreements at issue in the present case, which amounted to several million euros. Pharmaceutical undertakings do not often initiate litigation in all the Member States simultaneously. Usually, as the Lagap case in the United Kingdom shows (recital 63 of the contested decision), they decide to focus on a few test cases, rather than bringing multiple actions before different courts when the same issues are in question. In the Lagap case, however, the applicants ultimately decided to settle in order to avoid a defeat that would be used against them in other jurisdictions (recital 160 of the contested decision). |
| 390 | Poleg tega je v izpodbijanem sklepu potrjeno, da obstajajo drugi načini za mirno rešitev spora, sprejemljivi z vidika prava konkurence, kot pa preložitev vstopa potencialnih konkurentov na trg z obrnjenimi plačili, kot se je zgodilo v obravnavani zadevi (točka 354 zgoraj). V skladu s sodno prakso konkretnega predmeta patenta ni mogoče razlagati tako, da zagotavlja varstvo tudi pred tožbami za izpodbijanje veljavnosti patenta, ker je v javnem interesu, da se odpravijo vsakršne ovire za gospodarsko dejavnost, ki izhaja iz napačne podelitve patenta (zgoraj v točki 119 navedena sodba Windsurfing International/Komisija, EU:C:1986:75, točka 92). Čeprav sta tožeči stranki lahko utemeljeno sklenili poravnave z generičnimi podjetji zaradi preprečitve stroškov morebitnih sodnih postopkov, pa nista smeli s tem z njuno lastno presojo o veljavnosti njunih patentov in o tem, ali so proizvodi generičnih podjetij ponaredki ali ne, nadomestiti presoje neodvisnega sodišča, tako da sta generičnim podjetjem plačali za strinjanje s to presojo in opustitev vstopa na trg za določen čas. | 390 | Moreover, the contested decision acknowledges that there are ways of resolving a dispute amicably, which are acceptable from a competition law perspective, other than those consisting in delaying the market entry of potential competitors through reverse payments, as in the present case (paragraph 354 above). According to the case-law, the specific subject matter of the patent cannot be interpreted as also affording protection against actions brought in order to challenge the patent’s validity, in view of the fact that it is in the public interest to eliminate any obstacle to economic activity, which may arise where a patent was granted in error (see, to that effect, the Windsurfing judgment, cited in paragraph 119 above, EU:C:1986:75, paragraph 92). Although the applicants were entitled to enter into settlements with the generic undertakings in order to avoid the costs of potential litigation, they could not, on that ground, substitute their own assessment of the validity of their patents and the infringing nature of the generic undertakings’ products for that of an independent judge while paying the generic undertakings to comply with that assessment and refrain from entering the market for a certain period. |
| 391 | Zato je bilo v izpodbijanem sklepu pravilno ugotovljeno, da se je z obrnjenimi plačili spodbudilo generična podjetja v strinjanje z omejitvami njihove poslovne svobode, določenimi v spornih sporazumih, z drugimi pojasnili tožečih strank za utemeljitev teh plačil pa te ugotovitve ni mogoče ovreči. | 391 | Accordingly, the contested decision rightly concluded that the reverse payments had induced the generic undertakings to accept the limitations on their autonomy laid down in the agreements at issue, and the alternative explanations put forward by the applicants in order to justify those payments are not such as to call that conclusion into question. |
| 392 | Prvi del je treba zato zavrniti. | 392 | The first part must therefore be rejected. |
| 2. Drugi del | 2. The second part |
| 393 | Tožeči stranki menita, da je v izpodbijanem sklepu napačno ugotovljeno, da so pogodbene omejitve na podlagi spornih sporazumov odpravile druge spodbude za vstop na trg. | 393 | The applicants maintain that the contested decision wrongly finds that the contractual limitations imposed in the agreements at issue removed the other incentives to enter the market. |
| 394 | Na prvem mestu navajata, da omejitve, ki izhajajo iz obsega patentov, ne zmanjšujejo niti odpravljajo spodbud za nadaljevanje samostojnih prizadevanj za vstop na trg. Generična podjetja, ki privolijo v opustitev vstopa na trg s ponarejenimi zdravili v zameno za prenos vrednosti, bi torej lahko še vedno želela doseči sodno ugotovitev, da njihova zdravila niso ponaredki ali da domnevno kršeni patent ni veljaven. Sicer pa naj nič ne bi omogočalo sklepanja, da se s plačilom za opustitev dajanja ponarejenih zdravil na trg zmanjša spodbuda generičnemu podjetju za nadaljnje prizadevanje za vstop na trg z neponarejenimi zdravili. To, da se generično podjetje zadovolji z vrednostjo, ki jo prenese proizvajalec originalnih zdravil, in ne skuša izpodbijati upoštevni patent, čeprav ni nobene določbe o prepovedi izpodbijanja, pomeni samo to, da to podjetje dvomi o svojih možnostih za uspešno razveljavitev patenta. | 394 | They submit, in the first place, that the limitations falling within the scope of the patents do not reduce or eliminate incentives to sustain independent efforts to enter the market. Thus, the generic undertakings which agree to refrain from entering the market with infringing medicinal products in exchange for a value transfer might still want to obtain a judgment finding that their medicinal products are non-infringing or that the patent which is alleged to be infringed is invalid. Nor is there any reason to conclude that a payment for refraining to launch infringing medicinal products will reduce a generic undertaking’s incentive to maintain its efforts to enter the market with non-infringing medicinal products. The fact that a generic undertaking is satisfied with the value transferred by the originator undertaking and does not seek to challenge the relevant patent, in spite of the absence of a no-challenge clause, suggests only that that undertaking lacks confidence in its chances of having the patent declared invalid. |
| 395 | Zato tožeči stranki menita, da zakonita domneva, po kateri izključitev s trga zaradi plačila omejuje konkurenco zaradi cilja, s tem, da zmanjša ali odpravi spodbudo generičnim podjetjem za nadaljevanje samostojnega prizadevanja za vstop na trg, lahko nastane, samo kadar pogodbene omejitve ne izhajajo iz obsega upoštevnega patenta. | 395 | The applicants therefore maintain that a legal presumption that market exclusion in exchange for a payment constitutes a restriction by object by reducing or eliminating the generic undertakings’ incentive to pursue independent efforts to enter the market can arise only if the contractual restrictions fall outside the scope of the relevant patent. |
| 396 | Na drugem mestu, tožeči stranki menita, da v izpodbijanem sklepu ni zadostno obrazložena ugotovitev, da prenosi vrednosti neizpodbitno zmanjšujejo spodbude generičnim podjetjem za sprožitev sodnih postopkov. V izpodbijanem sklepu naj bi bilo priznano, da je možnost sklenitve poravnave z obrnjenim plačilo nekaj časa po vložitvi tožbe zoper proizvajalca originalnih zdravil lahko spodbuda generičnemu podjetju za vložitev take tožbe (točka 711 obrazložitve). To priznanje naj bi bilo v nasprotju s sklepanjem v izpodbijanem sklepu, po katerem bi obrnjena plačila verjetno zgolj odvrnila generična podjetja od sprožitve sodnih postopkov (točka 966 obrazložitve). To notranje neskladje naj bi razkrivalo, da izpodbijani sklep ne temelji na dosledni ekonomski podlagi, in zmanjšuje težo njegovega sklepanja, da so „znatna“ obrnjena plačila nujno v škodo potrošnikov (točka 646 obrazložitve). | 396 | In the second place, the applicants maintain that the contested decision does not state sufficient reasons for its finding that the value transfers indisputably reduce the generic undertakings’ incentive to litigate. The contested decision acknowledges that the prospect of entering into a settlement agreement specifying a reverse payment some time after initiating proceedings against the originator undertaking may provide an incentive for the generic undertakings to bring such an action (recital 711). That recognition contradicts the contested decision’s reasoning that reverse payments would in all likelihood only deter generic undertakings from initiating proceedings (recital 966). That internal inconsistency shows that the contested decision lacks a rigorous economic foundation and undermines the finding that ‘considerable’ reverse payments must be bad for consumers (recital 646). |
| 397 | Komisija te trditve zavrača. | 397 | The Commission disputes those arguments. |
| 398 | Najprej, v zvezi s trditvijo tožečih strank, da sporni sporazumi ne vsebujejo nobenih določb, ki bi generičnim podjetjem preprečevale izpodbijanje veljavnosti njunih patentov, zato ti sporazumi niso odpravili vsakršne spodbude za vstop teh podjetij na trg, je treba najprej ugotoviti, da je taka trditev brezpredmetna, ker je v izpodbijanem sklepu ugotovljeno samo to, da so v spornih sporazumih določena nasprotna plačila spodbudila generična podjetja v strinjanje z omejitvami njihove poslovne svobode, s katerimi se sicer ne bi strinjala, ne pa da so odpravila kakršno koli spodbudo v zvezi s tem (točke 604 in od 659 do 661 obrazložitve izpodbijanega sklepa). | 398 | As regards the applicants’ argument that the agreements at issue did not contain any provision preventing the generic undertakings from contesting the validity of their patents, with the result that those agreements did not remove all incentive for those undertakings to enter the market, it must be pointed out, first of all, that that argument is ineffective, since the contested decision states only that the reverse payments provided for in the agreements at issue encouraged or induced the generic undertakings to accept limitations on their commercial autonomy that they would not have accepted in the absence of those payments, and not that they removed all incentives in that respect (recitals 604 and 659 to 661 of the contested decision). |
| 399 | Tudi če namreč sporni sporazumi ne bi vsebovali nobene določbe o neizpodbijanju, generična podjetja ne bi imela interesa za izpodbijanje patentov družbe Lundbeck po sklenitvi spornih sporazumov, ker so obrnjena plačila približno ustrezala njihovim pričakovanim donosom ob vstopu na trg ali odškodninam, ki bi jih lahko prejela ob uspehu v sodnih postopkih zoper družbo Lundbeck (glej točko 388 zgoraj). Tudi če bi bila ta plačila nižja od pričakovanih donosov, bi vendarle šlo za zanesljiv in takojšen donos brez tveganj zaradi vstopa na trg. Sicer pa dejansko stanje v obravnavani zadevi potrjuje tako razlago, ker nobeno generično podjetje ni izpodbijalo patentov družbe Lundbeck niti ni vstopilo na trg med trajanjem spornih sporazumov. Čeprav je podjetje Merck (GUK) v Združenem kraljestvu po poteku sporazuma GUK za Združeno kraljestvo za nekaj dni dejansko vstopilo na trg citaloprama, pa je bilo to zato, ker je menilo, da pogoji, ki jih je za podaljšanje tega sporazuma predlagala družba Lundbeck, niso bili dovolj dobri in je želelo donosnejše povračilo za drugo podaljšanje tega sporazuma (točka 299 obrazložitve izpodbijanega sklepa). | 399 | In any case, even though the agreements at issue did not contain any no-challenge clause, the generic undertakings had no incentive to challenge Lundbeck’s patents after concluding the agreements at issue, since the reverse payments broadly correspond to the profits that the generic undertakings expected to make if they had entered the market or to the damages that they would have obtained if they had succeeded in litigation against Lundbeck (see paragraph 388 above). Even if those payments were less than the expected profits, they nevertheless constituted a certain and immediate profit, without necessitating the risks that market entry would have entailed. Moreover, the events in the present case support that interpretation, since no generic undertakings contested Lundbeck’s patents or entered the market during the term of the agreements at issue. Although Merck (GUK) indeed entered the citalopram market in the United Kingdom for a few days, after the expiry of the GUK United Kingdom agreement, it did so because it considered that the conditions offered by Lundbeck in order to extend that agreement were not good enough and it wanted more lucrative remuneration in exchange for a second extension of that agreement (recital 299 of the contested decision). |
| 400 | Dalje, v delu v katerem tožeči stranki trdita, da bi generična podjetja lahko vstopila na trg z neponarejenimi generičnimi proizvodi, je treba napotiti na sklepanje spodaj pri šestem tožbenem razlogu glede obravnave vsebine in področja uporabe spornih sporazumov. | 400 | Next, inasmuch as the applicants claim that the generic undertakings could have entered the market using non-infringing generic products, reference must be made to the examination below of the sixth plea in law, relating to the assessment of the content and scope of the agreements at issue. |
| 401 | Vsekakor pa je v izpodbijanem sklepu pravilno ugotovljeno, tudi če bi omejitve iz spornih sporazumov spadale v obseg patentov družbe Lundbeck v tem smislu, da bi jih bilo mogoče doseči tudi v sodnih postopkih, da je šlo zgolj za možnost v času sklenitve spornih sporazumov. Nadomestitev te negotovosti v zvezi s ponarejenostjo proizvodov generičnih podjetij in veljavnostjo patentov tožečih strank z gotovostjo, da generična podjetja ne bodo vstopila na trg med trajanjem spornih sporazumov, je sama po sebi omejitev konkurence zaradi cilja v obravnavani zadevi, ker je bil tak rezultat dosežen z obrnjenim plačilom (glej točki 336 in 363 zgoraj). | 401 | In any event, even if the restrictions contained in the agreements at issue potentially fell within the scope of Lundbeck’s patents, in that they could also have been obtained through litigation, the contested decision rightly finds that this was merely a possibility at the time the agreements at issue were concluded. Replacing that uncertainty in relation to whether or not the generic undertakings were infringing and to the validity of the applicants’ patents with the certainty that the generic undertakings would not enter the market during the term of the agreements at issue constitutes, as such, a restriction on competition by object in the present case, since that result was obtained through a reverse payment (see paragraphs 336 and 363 above). |
| 402 | Nazadnje, tožeči stranki ne moreta uspeti s trditvijo, da izpodbijani sklep v zvezi s tem ni zadostno obrazložen. Več delov izpodbijanega sklepa, v katerih se obravnavajo obrnjena plačila in na katere se tožeči stranki sklicujeta, namreč kaže na to, da sta razumeli tezo Komisije v zvezi s tem, čeprav se z njo ne strinjata. Sicer pa v izpodbijanem sklepu ni nobenega nasprotja pri tem, ko na eni strani priznava, da možnost obrnjenih plačil proizvajalca originalnih zdravil lahko spodbudi generična podjetja k vložitvi tožb, na drugi strani pa bi obrnjena plačila v skladu s spornimi sporazumi odvrnila generična podjetja od vložitve takih tožb v obravnavani zadevi. Kot je namreč Komisija v bistvu navedla zlasti v točkah 639 in 660 obrazložitve izpodbijanega sklepa, poravnave z določenimi plačili – celo obrnjenimi – niso vedno problematične z vidika prava konkurence, zlasti kadar ne določajo nobene omejitve za vstop generikov na trg in se z njimi, nasprotno, generičnim podjetjem nadomesti izgubljeni dobiček, ko proizvajalec originalnih zdravil potrdi, da se z njihovimi generičnimi proizvodi ne krši noben patent. | 402 | Lastly, the applicants cannot succeed in their argument that the contested decision fails to state sufficient reasons in that respect. The numerous passages in the contested decision relating to the reverse payments, referred to by the applicants themselves, show that they understood the Commission’s view in that respect, even if they did not share it. In addition, there is no contradiction, in the contested decision, in the fact that it acknowledges, on the one hand, that the possibility of obtaining reverse payments from the originator undertaking may encourage the generic undertakings to bring legal actions, whereas, on the other hand, the reverse payments obtained under the agreements at issue would have dissuaded the generic undertakings from bringing such actions in the present case. As the Commission indicates, in essence, in recitals 639 and 660 of the contested decision, inter alia, settlements providing for payments — even reverse payments — are not always problematic from a competition law perspective, particularly when they are not accompanied by any restriction on the market entry of generics but are intended, on the contrary, to offer compensation to the generic undertakings for their lost profits, once the originator undertaking acknowledges that their generic products do not infringe any patent. |
| 403 | Zato je treba skleniti, da Komisija ni storila napake pri presoji, ko je v izpodbijanem sklepu ugotovila, da so omejitve iz spornih sporazumov, dosežene v zameno za znatna obrnjena plačila, zmanjšale spodbudo generičnim podjetjem za vstop na trg. | 403 | Consequently, it must be concluded that the Commission did not commit any error of assessment in finding, in the contested decision, that the restrictions set out in the agreements at issue — obtained in exchange for significant reverse payments — had reduced the incentives for the generic undertakings to enter the market. |
| 404 | Zato je treba tudi drugi del zavrniti. | 404 | Accordingly, the second part must also be rejected. |
| 3. Tretji del | 3. The third part |
| 405 | Tožeči stranki menita, da v izpodbijanem sklepu uporabljeni standard, po katerem s prenosom vrednosti spodbujene patentne poravnave omejujejo konkurenco zaradi cilja, ni izvedljiv. | 405 | The applicants maintain that the standard applied in the decision, namely that patent settlement agreements induced by a value transfer constitute restrictions of competition by object, is unworkable. |
| 406 | Navajata, prvič, da ta standard notranje ni skladen in da odvrača od sklenitve sporazumov, ki določajo hiter vstop na trg in koristijo potrošnikom, ker ima drugačne posledice glede na to, ali se prenos vrednosti izvede v obliki gotovinskega plačila ali v obliki hitrega vstopa na trg. | 406 | First, they claim that that standard is intrinsically inconsistent and has a dissuasive effect on the conclusion of agreements providing for early market entry, which benefit consumers, since it leads to different results depending on whether the value transfer takes the form of a cash payment or a rapid entry to the market. |
| 407 | Drugič, menita da sporazum ne more temeljiti „izključno“ na oceni strank o moči patenta, in da standard, ki ga je uporabila Komisija, v praksi prepoveduje kakršno koli obrnjeno plačilo. Nobena poravnava ne more temeljiti „izključno“ na oceni strank o moči patenta preprosto zato, ker naj „moč“ patenta ne bi bila določen pojem. Če bi se zahtevalo, da morajo poravnave temeljiti „izključno“ na oceni strank o moči patenta, bi se s tem zahtevalo, da stranke sprožijo sodne postopke. Sklep naj ne bi dopuščal nobenega manevrskega prostora za uporabo obrnjenega plačila za odvračanje generičnega podjetja od kršitev patentov proizvajalca originalnih zdravil. | 407 | Secondly, they maintain that an agreement cannot be based ‘purely’ on the parties’ assessment of the strength of the patent and that the standard applied by the Commission prohibits, in practice, all reverse payments. No settlement agreement can be based ‘purely’ on the parties’ assessment of the strength of the patent, for the simple reason that the ‘strength’ of a patent is not a clear-cut concept. If settlement agreements had to be based ‘purely’ on the parties’ assessment of the strength of the patent, that would amount to requiring the parties to litigate. The decision leaves no discretion to the parties to use a reverse payment in order to deter a generic undertaking from infringing an originator undertaking’s patents. |
| 408 | Tretjič, tožeči stranki menita, da pravni preizkus na podlagi plačanega zneska v praksi ni izvedljiv, ker v izpodbijanem sklepu ni določen noben jasen prag za ugotavljanje, ali je plačilo sprejemljivo ali protikonkurenčno. | 408 | Thirdly, the applicants submit that the legal test based on the amount of the payment is unworkable in practice, since the contested decision established no clear threshold for the purpose of determining whether a payment is acceptable or anticompetitive. |
| 409 | Komisija te trditve zavrača. | 409 | The Commission disputes those arguments. |
| 410 | Prvič, trditev tožečih strank, da izpodbijani sklep odvrača poravnave, ki določajo hiter vstop generikov na trg, očitno ni utemeljena, ker je Komisija nasprotno menila, da so sporni sporazumi problematični z vidika prava konkurence, ker je bil njihov cilj preložitev vstopa generikov na trg in ne olajševanje takega vstopa. Sicer pa je treba spomniti, da je Komisija upoštevala tudi, da sporni sporazumi ne vsebujejo nobene zaveze družbe Lundbeck, da ne bo tožila generičnih podjetij zaradi kršitev, če bi ta vstopila na trg citaloprama po njihovem poteku (točka 662 obrazložitve izpodbijanega sklepa). | 410 | First, the Court finds that the applicants’ argument that the contested decision will have a dissuasive effect on the conclusion of settlement agreements providing for the rapid market entry of generics is manifestly unfounded, since the Commission, on the contrary, considered that the agreements at issue were problematic from a competition law perspective because their object was to delay the market entry of generics and not to facilitate such entry. Moreover, it must be recalled that the Commission also took account of the fact that the agreements at issue did not contain any commitment from Lundbeck to refrain from bringing infringement proceedings against the generic undertakings if the latter entered the market with generic citalopram after the expiry of the agreements (recital 662 of the contested decision). |
| 411 | Poleg tega je v izpodbijanem sklepu potrjeno, da poravnave v nekaterih primerih niso problematične, tudi če vsebujejo obrnjena plačila, če poleg tega določajo takojšen vstop generikov na trg (glej primer družbe Neolab, naveden zgoraj v točki 350). Komisija je povsem utemeljeno različno obravnavala sporazume z obrnjenimi plačili in tiste brez takih plačil, ker tako plačilo spodbuja generična podjetja k sprejetju omejitev, ki jih brez tega ne bi sprejela (glej točko 349 in naslednje zgoraj). Sicer pa sporazum, ki omogoča hitrejši vstop na trg, seveda ni problematičen z vidika prava konkurence, zato takega povračila za druge zaveze iz poravnave ni mogoče primerjati z obrnjenim plačilom, s katerim se želi preložiti tak vstop. | 411 | Furthermore, the decision acknowledges that, in certain cases, settlements are not problematic, even when they provide for reverse payments, if they also provide for the immediate market entry of generics (see the example of Neolab, cited in paragraph 350 above). The Commission’s treatment of the agreements accompanied by a reverse payment differently from those which did not provide for a reverse payment is entirely justifiable, in view of the incentive that such a payment provides to the generic undertakings to accept restrictions that they would not have accepted in the absence of that incentive (see paragraph 349 et seq. above). In addition, an agreement allowing quicker market entry is clearly not problematic as regards competition law, with the result that the provision of such consideration for other commitments contained in a settlement is not comparable to a reverse payment intended to delay such entry. |
| 412 | Drugič, spomniti je treba, da v izpodbijanem sklepu ni ugotovljeno, da mora sporazum temeljiti izključno na oceni strank tega sporazuma o moči patenta, da se člen 101(1) PDEU ne uporablja (točka 360 zgoraj). Tožeči stranki torej napačno trdita, da se z izpodbijanim sklepom odpravlja kakršna koli spodbuda za sklenitev patentnih poravnav, kar vodi v plaz sodnih postopkov po celotnem EGP. Komisija je namreč izpodbijala samo tiste sporazume v obliki poravnav, katerih cilj v resnici ni rešitev osnovnega patentnega spora med strankami takega sporazuma in ki določajo obrnjena plačila v zameno za zavezo generičnih podjetij, da ne bodo vstopila na trg. Sicer pa proizvajalec originalnih zdravil, čeprav je Komisija res menila, da so takih sporazumi protikonkurenčni, ni zavezan sprožiti sodnih postopkov za zaščito svojih patentov v vseh državah EGP, ker lahko vedno na primer sklene poravnave brez obrnjenih plačil ali poravnave, ki kljub določitvi takih plačil ne določajo nobene omejitve za vstop generikov na trg (glej primer družbe Neolab, naveden zgoraj v točki 350). | 412 | Secondly, it must be recalled that the contested decision does not establish that an agreement must be based exclusively on the assessment of the parties to that agreement of the strength of a patent in order for Article 101(1) TFEU not to apply (paragraph 360 above). The applicants are therefore wrong in their submission that the contested decision removes all incentive to conclude patent settlements, thus leading to an avalanche of litigation throughout the EEA. The Commission criticised only the agreements concluded in the form of settlements, as in the present case, the real purpose of which is not to resolve the underlying patent dispute between the parties to that agreement and which provide for reverse payments in exchange for the generic undertakings’ commitment not to enter the market. In addition, while it is true that the Commission considered that such agreements were anticompetitive, there is no obligation on the originator undertaking to initiate litigation in every EEA jurisdiction in order to protect its patents, since it is still possible, for example, to conclude settlements which do not contain any reverse payment or to conclude settlements which, although they provide for such payments, are not accompanied by any restriction on the market entry of generics (see the example of Neolab, cited in paragraph 350 above). |
| 413 | Nazadnje, trditev tožečih strank, da jima izpodbijani sklep ne pušča nobenega manevrskega prostora za uporabo obrnjenih plačil za odvračanje generičnih podjetij od kršitev njunih patentov, ponovno temelji na napačni premisi, da se s proizvodi generičnih podjetij kršijo njuni patenti, čeprav to v času sklenitve spornih sporazumov ni bilo dokazano. | 413 | Lastly, the applicants’ argument that the contested decision did not allow them any discretion to use reverse payments in order to dissuade the generic undertakings from infringing their patents is again based on the erroneous premiss that the products of the generic undertakings infringed their patents, whereas this had not been established at the time the agreements at issue were concluded. |
| 414 | Tretjič, Komisija je v izpodbijanem sklepu pojasnila, da so bila obrnjena plačila v obravnavani zadevi še posebej problematična, ker so zneski iz spornih sporazumov v glavnem ustrezali pričakovanim donosom generičnih podjetij ob vstopu na trg ali odškodninam, ki bi jih lahko pridobila, če bi uspela v sodnih postopkih zoper družbo Lundbeck (točka 388 zgoraj). V takem primeru je namreč vsakršna spodbuda generičnim podjetjem za vstop na trg bistveno zmanjšana, če ne odpravljena. Pomembno je torej to, da so bili v obravnavani zadevi zneski obrnjenih plačil, določeni v vsakem od spornih sporazumov, dovolj visoki za to, da so generična podjetja lahko privolila v omejitev njihove samostojnosti in za to, da se je zmanjšala njihova spodbuda za vstop na trg z generičnimi proizvodi (glej zlasti točko 644 obrazložitve izpodbijanega sklepa). | 414 | Thirdly, the Commission explained, in the contested decision, that the reverse payments were particularly problematic, in the present case, since the amounts provided for in the agreements at issue broadly corresponded to the profits expected by the generic undertakings if they had entered the market or to the damages that they would have obtained if they had succeeded in litigation against Lundbeck (paragraph 388 above). In such a case, any incentive for the generic undertakings to enter the market is considerably reduced, if not eliminated. What is important, therefore, is that in the present case the amounts of the reverse payments provided for in each of the agreements at issue were sufficiently high to allow the generic undertakings to accept the limitations on their autonomy and to reduce their incentives to enter the market with their generic products (see inter alia recital 644 of the contested decision). |
| 415 | Res je, da se je Komisija pri dokazovanju obstoja omejitve zaradi cilja v obravnavani zadevi oprla na več dejavnikov (glej točko 354 zgoraj ter točki 661 in 661 obrazložitve izpodbijanega sklepa). Vendar tožeči stranki ne moreta Komisiji očitati, da v izpodbijanem sklepu ni zadostno pojasnila, kolikšen pomen pripisuje temu, da so obrnjena plačila ustrezala pričakovanim donosom generičnih podjetij. Vsekakor je treba izpostaviti – tako kot je to storila Komisija – da ta ni zavezana, da v svojih odločbah določi splošne pravne standarde, ampak samo to, da v vsakem posamičnem primeru ugotovi, ali so obravnavani sporazumi v skladu z določbami Pogodbe o konkurenci, in jih v zvezi s tem obrazloži dovolj jasno in prepričljivo. Na podlagi navedenega pa je treba ugotoviti, da je Komisija te zahteve v obravnavani zadevi izpolnila. | 415 | It is true that the Commission relied on a series of factors in order to establish the existence of a restriction by object in the present case (see paragraph 354 above and recitals 661 and 662 of the contested decision). However, the applicants cannot succeed in their submission that the Commission did not sufficiently clarify, in the contested decision, the significance that it attached to the fact that the reverse payments corresponded to the profits expected by the generic undertakings. In any event, as the Commission emphasises, it is not required, in its decisions, to lay down generally applicable legal rules, but only to determine, in each specific case, whether the agreements that it examines are compatible with the treaty provisions on competition, giving sufficiently clear and convincing reasons in that respect. In view of the foregoing, it must be held that the Commission satisfied those requirements in the present case. |
| 416 | Zato je treba tretji del in torej drugi tožbeni razlog v celoti zavrniti. | 416 | Accordingly, the third part of the plea must be rejected, as must the second plea in law in its entirety. |
| D – Tretji tožbeni razlog: očitno napačna uporaba prava pri uporabi načel v zvezi z omejevanjem konkurence zaradi cilja | D – The third plea in law, alleging a manifest error of law in the application of the principles relating to the notion of restriction of competition by object |
| 417 | Tožeči stranki menita, da je bilo v izpodbijanem sklepu napačno uporabljeno pravo z ugotovitvijo, da sporni sporazumi pomenijo omejevanje konkurence zaradi cilja na podlagi ustaljenih načel o razlagi člena 101(1) PDEU. Natančneje, sklep naj bi bil napačen, prvič, zaradi enačenja teh sporazumov s tistimi iz zadeve, v kateri je bila izdana zgoraj v točki 341 navedena sodba BIDS (EU:C:2008:643), in tistimi v drugih klasičnih zadevah v zvezi z razdelitvijo trga, ki se ne nanašajo na izvajanje patentov, drugič, z ugotovitvijo da lahko zgolj prenos vrednosti povzroči, da patentna poravnava omejuje konkurenco zaradi cilja, tretjič, ker se v njem ne priznava, da cilj spornih sporazumov, torej spoštovanje patentov družbe Lundbeck, onemogoča ugotovitev omejevanja konkurence zaradi cilja, in četrtič, s sklepanjem, da položaj, ki bi nastal brez spornih sporazumov (v nadaljevanju: scenarij v nasprotju z dejstvi), izključuje kakršno koli omejevanje konkurence zaradi cilja v obravnavani zadevi. | 417 | The applicants maintain that the contested decision is vitiated by an error of law since it concludes that the agreements at issue constitute restrictions of competition by object by applying the established principles applicable to the interpretation of Article 101(1) TFEU. In particular, the contested decision errs, first, by treating the agreements at issue in the present case as comparable to the agreements at issue in the case that gave rise to the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643), and in other classic market-sharing cases which did not involve patent enforcement; secondly, by finding that a value transfer could in itself make a patent settlement agreement restrictive by object; thirdly, by not recognising that the objective pursued by the agreements at issue in the present case, namely compliance with Lundbeck’s patents, precluded the finding of a restriction by object; and, fourthly, by failing to recognise that the situation that would have prevailed in the absence of the agreements at issue (‘the counterfactual scenario’) precluded the existence of any restriction of competition by object in the present case. |
| 1. Prvi del | 1. The first part |
| 418 | Tožeči stranki menita, da je Komisija storila napako, ko je v izpodbijanem sklepu sporne sporazume izenačila s sporazumi o razdelitvi trgov, kot so tisti iz zgoraj v točki 341 navedene sodbe BIDS (EU:C:2008:643). | 418 | The applicants submit that the Commission, in the contested decision, errs when it treats the agreements at issue as being equivalent to market-sharing agreements such as those at issue in the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643). |
| 419 | Tožeči stranki v zvezi s tem navajata, prvič, da se zadevni sporazumi iz zgoraj v točki 341 navedene sodbe BIDS (EU:C:2008:643) v nasprotju s položajem v obravnavani zadevi ne nanašajo na ohranitev patenta, ki daje njegovemu imetniku pravico, da prepreči vstop ponarejenih proizvodov na trg, in nepopravljivo škodo, ki bi jo tak vstop povzročil. | 419 | In that regard, first, the applicants claim that, unlike the situation in the present case, the agreements at issue in the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643), were not intended to preserve a patent which conferred on its holder the right to prevent the market entry of infringing products and the irreparable damage that would have followed from such an entry. |
| 420 | Drugič, v nasprotju s položajem v obravnavani zadevi naj bi podjetja, ki so izstopala z upoštevnega trga v skladu z zadevnimi sporazumi iz zgoraj v točki 341 navedene sodbe BIDS (EU:C:2008:643), zanesljivo konkurirala podjetjem, ki so ostala na tem trgu, če ti sporazumi ne bi bili sklenjeni. | 420 | Secondly, unlike the situation in the present case, the undertakings leaving the relevant market under the agreements at issue in the case that gave rise to the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643), would certainly have competed with the undertakings remaining on the market if those agreements had not been concluded. |
| 421 | Tretjič, v nasprotju s sklepanjem v obravnavani zadevi bi se zadevni sporazumi iz zgoraj v točki 341 navedene sodbe BIDS (EU:C:2008:643) obravnavali kot taki, ki omejujejo konkurenco, celo če ne bi bilo plačila. To da so v navedeni zadevi obstajala izravnalna plačila, naj ne bi bilo odločilno za presojo, da so ti sporazumi pomenili omejevanje konkurence zaradi cilja. | 421 | Thirdly, unlike the reasoning used in the present case, the agreements at issue in the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643), would have been deemed to be restrictive of competition even in the absence of any payment. The fact that in that case compensatory payments were involved was not decisive for the conclusion that those agreements had as their object the restriction of competition. |
| 422 | Komisija te trditve zavrača. | 422 | The Commission disputes those arguments. |
| 423 | Prvič, ugotoviti je treba, da Komisija v točkah 657 in 658 obrazložitve izpodbijanega sklepa ni napačno uporabila prava pri uporabi analogije med sporazumi iz zgoraj v točki 341 navedene sodbe BIDS (EU:C:2008:643) in spornimi sporazumi. | 423 | First, it must be pointed out that the analogy made by the Commission in recitals 657 and 658 of the contested decision, between the agreements at issue in the case that gave rise to the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643), and the agreements at issue in the present case, is not vitiated by any error of law. |
| 424 | Kot namreč izhaja zlasti iz točke 8 navedene sodbe, so v navedeni zadevi podjetja, ki so poslovala na trgu predelave govejega mesa na Irskem, uvedla mehanizem, po katerem so se nekatera podjetja zavezala, da bodo dve leti ostala zunaj navedenega trga, tista podjetja, ki so ostala na tem trgu, pa so jim za to plačala. Podobna dinamika je nastala v obravnavani zadevi s sklenitvijo spornih sporazumov, v skladu s katerimi je družba Lundbeck kot glavno ali celo edino podjetje, prisotno na trgu vseh držav, ki jih zadevajo ti sporazumi, plačalo generičnim podjetjem, ki so bila potencialni konkurenti, da za določen čas ostanejo zunaj trga. | 424 | As can be seen from, inter alia, paragraph 8 of that judgment, in that case, the undertakings active in the beef processing market in Ireland had created a mechanism by which some undertakings agreed to stay out of that market for two years in exchange for payments from the undertakings that stayed in the market. A similar dynamic arose in the present case through the conclusion of the agreements at issue, pursuant to which Lundbeck, which was the principal, or even the only, undertaking on the market in the countries concerned by those agreements, paid the generic undertakings, which were potential competitors, so that they would stay out of the market for a certain period. |
| 425 | Iz tega sledi, da gre tako v zgoraj v točki 341 navedeni sodbi BIDS (EU:C:2008:643) kot v obravnavani zadevi za sporazume, ki omejujejo možnost konkurenčnih gospodarskih subjektov, da samostojno določajo politiko, ki jo želijo uresničevati na trgu, s preprečitvijo običajnega delovanja konkurence (glej v tem smislu zgoraj v točki 341 navedeno sodbo BIDS, EU:C:2008:643, točke od 33 do 35). | 425 | It follows that both the case that gave rise to the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643), and the present case concern agreements that limited the ability of competing economic operators to determine independently the policy that they intended to adopt on the market, by preventing the normal operation of the competitive process (see, to that effect, the BIDS judgment, cited in paragraph 341 above, EU:C:2008:643, paragraphs 33 to 35). |
| 426 | V zvezi s trditvijo tožečih strank, da so bili sporni sporazumi drugače kot v zadevi, v kateri je bila izdana zgoraj v točki 341 navedena sodba BIDS (EU:C:2008:643), sklenjeni v okoliščinah, ko sta imeli patente, ki so jima omogočali preprečitev vstopa ponarejenih proizvodov na trg, je treba najprej spomniti, da v obravnavani zadevi obstoj novih patentiranih postopkov družbe Lundbeck ni onemogočal obravnavanja generičnih podjetij kot njenih potencialnih konkurentov, kot izhaja iz obravnave prvega tožbenega razloga. Po členu 101 PDEU pa je potencialna konkurenca varovana enako kot dejanska konkurenca (glej točko 99 zgoraj). | 426 | As regards the applicants’ argument that, unlike in the case that gave rise to the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643), the agreements at issue in the present case were concluded in a context in which they held patents allowing them to prevent the market entry of infringing products, it must be pointed out, first of all, that in the present case, the existence of Lundbeck’s new process patents did not mean that the generic undertakings could not be regarded as potential competitors of Lundbeck, as can be seen from the analysis of the first plea in law. Article 101 TFEU protects potential competition as well as actual competition (see paragraph 99 above). |
| 427 | Poleg tega je treba spomniti, da v skladu s sodno prakso določen sporazum ni izvzet iz prava konkurence samo zato, ker se nanaša na patent ali se želi z njim patentni spor rešiti s poravnavo (glej v tem smislu sodbo z dne 27. septembra 1988, Bayer in Maschinenfabrik Hennecke, 65/86, ZOdl., EU:C:1988:448, točka 15). Poleg tega je mogoče šteti, da ima sporazum omejevalen namen, tudi če njegov edini namen ni omejevanje konkurence, ampak sledi tudi drugim, legitimnim ciljem (glej zgoraj v točki 341 navedeno sodbo BIDS, EU:C:2008:643, točka 21 in navedena sodna praksa). | 427 | In addition, it must be recalled that, according to the case-law, an agreement is not exempt from competition law merely because it concerns a patent or is intended to settle a patent dispute (see, to that effect, judgment of 27 September 1988 in Bayer and Maschinenfabrik Hennecke, 65/86, ECR, EU:C:1988:448, paragraph 15). Furthermore, an agreement may be regarded as having a restrictive object even if it does not have the restriction of competition as its sole aim but also pursues other legitimate objectives (see the BIDS judgment, cited in paragraph 341 above, EU:C:2008:643, paragraph 21 and the case-law cited). |
| 428 | Drugič, čeprav je res, da so bila zadevna podjetja v zadevi, v kateri je bila izdana zgoraj v točki 341 navedena sodba BIDS (EU:C:2008:643), dejanski konkurenti, ker se je nameravalo z zadevnimi sporazumi doseči izstop s trga podjetij, ki so bila tam že prisotna, medtem ko so bili v obravnavani zadevi družba Lundbeck in generična podjetja zgolj potencialni konkurenti, pa Sodišče v navedeni sodbi od Komisije kljub temu ni zahtevalo dokaza, da bi podjetja brez sporazumov ostala na trgu. Analiza učinkov sporazumov je namreč pri omejevanju konkurence zaradi cilja nepotrebna (glej točko 341 zgoraj). Sodišče je v navedeni zadevi ugotovilo samo to, da sta obravnavana sporazuma namenjena temu, da več podjetjem omogočita izvajanje skupne politike, katere cilj je spodbujanje nekaterih izmed teh podjetij, da se umaknejo s trga, s čimer naj bi se posledično zmanjšale presežne zmogljivosti, ki vplivajo na njihovo donosnost s tem, da jim preprečujejo doseči ekonomičnost obsega. Zato je ugotovilo, da ta vrsta sporazumov očitno nasprotuje zasnovi določb Pogodbe v zvezi s konkurenco, v skladu s katerimi vsak gospodarski subjekt samostojno določi politiko, ki jo namerava voditi na trgu, ob tem pa spomnilo, da je namen člena 101(1) PDEU prepovedati vse oblike usklajevanja, ki tveganja konkurence namenoma nadomestijo s praktičnim sodelovanjem med podjetji (zgoraj v točki 341 navedena sodba BIDS, EU:C:2008:643, točki 33 in 34). | 428 | Secondly, although it is true that, in the case that gave rise to the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643), the undertakings at issue were actual competitors, since the agreements in that case were intended to remove from the market undertakings which were already present on that market, whereas, in the present case, Lundbeck and the generic undertakings were merely potential competitors, it is nevertheless the case that, in the BIDS judgment, the Court of Justice did not require the Commission to demonstrate that, in the absence of those agreements, the undertakings would have stayed on the market. In the context of a restriction of competition by object, it is unnecessary to examine the effects of the agreements (see paragraph 341 above). The Court merely found, in that case, that the agreements in question were intended to implement a common policy which had as its object the encouragement of some of them to withdraw from the market and the reduction, as a consequence, of the overcapacity which affected their profitability by preventing them from achieving economies of scale. It therefore held that that type of agreement conflicted patently with the concept inherent in the treaty provisions relating to competition, according to which each economic operator must determine independently the policy which it intends to adopt on the common market, noting that Article 101(1) TFEU is intended to prohibit any form of coordination which deliberately substitutes practical cooperation between undertakings for the risks of competition (see the BIDS judgment, cited in paragraph 341 above, EU:C:2008:643, paragraphs 33 and 34). |
| 429 | V obravnavani zadevi pa so stranke spornih sporazumov dale prednost nadomestitvi tveganj, ki so značilna za običajno konkurenco, negotovosti v zvezi z veljavnostjo patentiranih postopkov družbe Lundbeck in vprašanjem, ali se s proizvodi, ki so jih nameravala tržiti generična podjetja, ti patenti kršijo ali ne, z gotovostjo, da ne bodo vstopila na trg med trajanjem teh sporazumov, z znatnimi obrnjenimi plačili, ki so približno ustrezala donosom, ki bi jih dosegla, če bi vstopila na trg. Zato ni pomembno, ali bi podjetja zanesljivo vstopila na trg med trajanjem spornih sporazumov, ker se je ravno s temi sporazumi ta možnost odpravila in se nadomestila z gotovostjo, da tja ne bodo vstopila. Stranke spornih sporazumov so bile torej s takim ravnanjem lahko udeležene pri dobičku, ki ga je družba Lundbeck še naprej lahko ustvarjala na škodo potrošnikov, ki so še naprej plačevali višje cene kot bi jih, če bi generiki vstopili na trg (glej točke od 644 do 646 obrazložitve izpodbijanega sklepa). | 429 | In the present case, the parties to the agreements at issue preferred to replace the risks inherent in the normal competitive process and the state of uncertainty surrounding the validity of Lundbeck’s process patents and whether or not the products that the generic undertakings intended to market infringed those patents, with the certainty that those undertakings would not enter the market during the term of those agreements, in return for significant reverse payments which corresponded approximately to the profits that those undertakings would have made if they had entered the market. It is therefore irrelevant whether the undertakings would undoubtedly have entered the market during the term of the agreements at issue, since those agreements eliminated that very possibility, replacing it with the certainty that those undertakings would not enter the market with their products during that period. By doing so, the parties to the agreements at issue were able to share a part of the profits that Lundbeck continued to enjoy, to the detriment of consumers who continued to pay higher prices than those they would have paid if the generics had entered the market (see recitals 644 to 646 of the contested decision). |
| 430 | Tretjič, zavrniti je treba tudi trditev tožečih strank, da bi bili sporazumi iz zadeve, v kateri je bila izdana zgoraj v točki 341 navedena sodba BIDS (EU:C:2008:643), drugače od spornih sporazumov v obravnavani zadevi protikonkurenčni celo brez plačil, določenih v navedenih sporazumih. Ugotoviti je namreč treba – tako kot Komisija – da so bila plačila v navedenih dveh zadevah odločilna, ker so spodbudila podjetja za umik s trga. Tako je v zadevi, v kateri je bila izdana zgoraj v točki 341 navedena sodba BIDS (EU:C:2008:643), malo verjetno, da bi izstopajoča podjetja privolila v umik s trga brez plačil podjetij, ki so ostala. Podobno v obravnavani zadevi iz spisa izhaja, da generična podjetja brez obrnjenih plačil ne bi privolila v enostransko opustitev vstopa na trg, potem ko so izvedla precej ukrepov in velike naložbe. | 430 | Thirdly, the Court must also reject the applicants’ argument that, unlike the agreements at issue in the present case, the agreements at issue in the case that gave rise to the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643), would have been anticompetitive even in the absence of the payments provided for in those agreements. As the Commission submitted, in both cases, the payments played a decisive role in that they induced the undertakings to withdraw from the market. Thus, in the case that gave rise to the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643), it is unlikely that the ‘going’ undertakings would have agreed to withdraw from the market in the absence of payments from the ‘staying’ undertakings. Likewise, in the present case, it can be seen from the file that the generic undertakings would not have agreed to stay out of the market unilaterally, after having taken significant steps and having made significant investments, in the absence of reverse payments. |
| 431 | Komisija je resda potrdila, da sklenitev patentne poravnave v nekaterih primerih ni protikonkurenčna, zlasti kadar ta temelji na oceni vsake stranke sporazuma o moči patentov, ali kadar določa obrnjeno plačilo, ne da bi odložila vstop generikov na trg (točki 638 in 639 obrazložitve izpodbijanega sklepa). Vendar je v obravnavani zadevi Komisija pravilno menila, da so bila obrnjena plačila odločilna, ker so omogočila družbi Lundbeck, da je dosegla zaveze generičnih podjetij, ki jih brez teh plačil ne bi mogla, in zato odložila njihov vstop na trg. | 431 | The Commission indeed acknowledged that, in certain cases, the conclusion of a patent settlement is not anticompetitive, particularly where it is based on the assessment of the strength of the patents made by each of the parties to the agreement, or where it provides for a reverse payment, without however delaying the market entry of generics (recitals 638 and 639 of the contested decision). In the present case, however, the Commission rightly considered that the reverse payments had played a decisive role, in that they had allowed Lundbeck to obtain commitments from the generic undertakings which they would not have been able to obtain in the absence of those payments, thereby delaying the market entry of those undertakings. |
| 432 | Tožeči stranki sta v odgovor na vprašanje Splošnega sodišča v zvezi s posledicami zgoraj v točki 78 navedene sodbe CB/Komisija (EU:C:2014:2204) navedli, da ta sodba potrjuje njuno stališče, da je Komisija napačno opredelila sporne sporazume kot omejitev konkurence zaradi cilja. Sodišče naj bi namreč, prvič, spomnilo, da je treba pojem omejevanja konkurence zaradi cilja razlagati ozko. Drugič, obstoj omejitve zaradi cilja naj bi bilo mogoče ugotoviti, samo če je sporazum sam po sebi dovolj škodljiv. Vendar naj bi bila v skladu z izpodbijanim sklepom za odgovor na vprašanje, ali je mogoče poravnavo oceniti kot skladno s pravom konkurence, potrebna temeljita analiza posameznega sporazuma z upoštevanjem dejanskega, gospodarskega in pravnega okvira. Prav tako naj bi iz notranjega sporočila KFST izhajalo, da Komisija ni menila, da je višina plačil v primeru družbe Lundbeck jasen primer podjetja, ki plačuje svoje konkurente za to, da ostanejo zunaj trga. Zato menita, da se Komisija s svojim pristopom v resnici želi izogniti analizi dejanskega stanja in dokaznemu bremenu, ki ga ima v zvezi z dokazovanjem obstoja omejitve konkurence na podlagi učinkov sporazuma. Tretjič, okoliščin sklenitve spornih sporazumov, torej zlasti obstoja veljavnih patentiranih postopkov, omejenega trajanja sporazumov, posebnega zakonodajnega okvira v EGP ter odsotnosti neponarejenih proizvodov na razpolago v dovolj kratkem roku, naj ne bi bilo mogoče zanemariti. Četrtič, pridobljene izkušnje naj bi bile pomembne pri ugotavljanju, ali je cilj določenega ravnanja omejevanje konkurence. Te izkušnje bi bilo treba razumeti tako, kot tradicionalno izhaja iz ekonomske analize, ki jo potrjujejo organi, pristojni za varstvo konkurence, in po potrebi sodna praksa. V obravnavani zadevi pa naj takih izkušenj ne bi bilo. | 432 | In answer to a question from the Court concerning the implications of the judgment in CB v Commission, cited in paragraph 78 above (EU:C:2014:2204), the applicants claimed that that judgment supported their view that the Commission had erred in classifying the agreements at issue as restrictions by object. First, the Court of Justice held that the concept of restriction by object had to be interpreted restrictively. Secondly, a restriction by object could be found only if the agreement revealed, in itself, a sufficient degree of harm. According to the contested decision, however, the question whether a settlement agreement may be deemed compatible with competition law requires a thorough analysis of the individual agreement, in the light of its factual, economic and legal context. It also follows from an internal KFST memorandum that the Commission had not considered that the size of the payments in the Lundbeck case constituted a clear example of a company paying its competitors to stay out of the market. The applicants maintain, therefore, that by its approach the Commission seeks in reality to avoid the factual analysis and the burden of proof which it bears when it has to establish a restriction of competition based on the effects of an agreement. Thirdly, the context in which the agreements at issue were concluded, namely, in particular, the existence of valid process patents, the limited duration of the agreements, the specific regulatory framework in the EEA and the absence of non-infringing products available within a sufficiently brief period, cannot be ignored. Fourthly, past experience is important for establishing whether conduct has the object of restricting competition. Past experience must be understood to mean what can traditionally be seen to follow from economic analysis, as confirmed by the competition authorities and supported, if necessary, by case-law. In fact, no experience of that type existed in the present case. |
| 433 | Komisija pa je pojasnila, da je uporabila ustaljeno sodno prakso na tem področju, na kakršno je opozorilo Sodišče v zgoraj v točki 78 navedeni sodbi CB/Komisija (EU:C:2014:2204). | 433 | The Commission explained that it applied the settled case-law in the area, as noted by the Court of Justice in the judgment in CB v Commission, cited in paragraph 78 above (EU:C:2014:2204). |
| 434 | Ugotoviti je treba namreč, da Sodišče z navedeno sodbo ni ovrglo temeljnih načel v zvezi s pojmom omejevanja „zaradi cilja“, ki izhajajo iz predhodne sodne prakse. Sodišče je resda v svoji sodbi zavrnilo analizo Splošnega sodišča iz sodbe z dne 29. novembra 2012, CB/Komisija (T‑491/07, EU:T:2012:633), ki je menilo, da pojma omejevanje konkurence „zaradi cilja“ ni treba razlagati ozko. Opozorilo je, da se pojem omejevanje konkurence „zaradi cilja“ lahko uporabi zgolj za nekatere vrste dogovorov med podjetji, pri katerih je stopnja škodljivosti za konkurenco taka, da je mogoče šteti, da ugotavljanje njihovih posledic ni potrebno, sicer bi bila Komisija odvezana dolžnosti dokazovanja dejanskih posledic sporazumov na trg, za katere nikakor ni ugotovljeno, da že po naravi škodujejo dobremu delovanju običajne konkurence (zgoraj v točki 78 navedena sodba CB/Komisija, EU:C:2014:2204, točka 58). | 434 | It must be observed that, by the judgment in CB v Commission, cited in paragraph 78 above (EU:C:2014:2204), the Court of Justice did not call into question the basic principles concerning the concept of a restriction ‘by object’ set out in the previous case-law. It is true that, in its judgment, the Court of Justice rejected the General Court’s analysis in the judgment of 29 November 2012 in CB v Commission (T‑491/07, EU:T:2012:633), according to which the concept of restriction of competition ‘by object’ should not be interpreted in a restrictive manner. The Court of Justice noted that the concept of restriction of competition ‘by object’ could be applied only to certain types of coordination between undertakings which revealed a sufficient degree of harm to competition that it could be found that there was no need to examine their effects, otherwise the Commission would be exempted from the obligation to prove the actual effects on the market of agreements which were in no way established to be, by their very nature, harmful to the proper functioning of normal competition (judgment in CB v Commission, cited in paragraph 78 above, EU:C:2014:2204, paragraph 58). |
| 435 | Iz celotne strukture izpodbijanega sklepa ter zlasti točk 802 in 1338 obrazložitve pa izhaja, da so bili sporni sporazumi primerljivi s sporazumi o izključitvi s trga, ki spadajo med najhujše omejitve konkurence. Izključitev konkurentov s trga je skrajna oblika razdelitve trga in omejevanja proizvodnje. Tožeči stranki ne moreta očitati Komisiji, da v obravnavani zadevi ni upoštevala obstoja njunih patentiranih postopkov ali zakonodajnega okvira EGP kot upoštevnih elementov okvira v zvezi s tem. Iz točk od 666 do 671 obrazložitve izpodbijanega sklepa izhaja, da je Komisija upoštevala patentirane postopke tožečih strank, menila pa je, da ti – tudi če so veljavni – ne dopuščajo izključevanja vsakršne konkurence v zvezi z AFU citalopram. Poleg tega je Komisija upoštevala tudi to, da je v času sklenitve spornih sporazumov obstajala negotovost glede veljavnosti patentov tožečih strank, zlasti patenta za kristalizacijo, in da se v času sklenitve spornih sporazumov o tem ni izreklo nobeno sodišče v EGP. | 435 | It follows from the general scheme of the contested decision and from recitals 802 and 1338 in particular, that the agreements at issue were comparable to market exclusion agreements, which are among the most serious restrictions of competition. The exclusion of competitors from the market constitutes an extreme form of market sharing and of limitation of production. The applicants cannot claim that the Commission did not take account of the existence of their process patents or of the specific legislative context of the EEA in the present case as relevant background factors in that respect. It can be seen from recitals 666 to 671 of the contested decision that the Commission took account of the applicants’ process patents, but took the view that, even if those patents were presumed to be valid, they did not allow the exclusion of all competition in relation to the citalopram API. In addition, the Commission also took account of the fact that there was uncertainty, at the time the agreements at issue were concluded, regarding the validity of the applicants’ patents, in particular the crystallisation patent, and that no court in the EEA had ruled on that issue at the time the agreements at issue were concluded. |
| 436 | Zato je treba presoditi, da je Komisija pravilno uporabila sodno prakso, navedeno v točkah od 339 do 345 zgoraj, v kateri se je ugotavljalo, ali se lahko za določen sporazum že po njegovi naravi šteje, da dovolj resno omejuje konkurenco, da bi ga bilo mogoče v določeni obravnavani zadevi opredeliti kot omejitev „zaradi cilja“ (glej med drugim točko 651 obrazložitve izpodbijanega sklepa). | 436 | Accordingly, it must be held that the Commission correctly applied the case-law referred to in paragraphs 338 to 344 above, which consists in determining whether an agreement may, by its very nature, be regarded as restricting competition in a sufficiently serious manner as to be classified as a restriction ‘by object’ in the case at hand (see, inter alia, recital 651 of the contested decision). |
| 437 | Zato Komisiji ni bilo treba analizirati tudi konkretnih učinkov spornih sporazumov na konkurenco in zlasti vprašanja, ali bi generična podjetja brez teh sporazumov vstopila na trg brez kršitve katerega od patentov družbe Lundbeck, zato da dokaže obstoj omejevanja konkurence zaradi cilja v smislu člena 101(1) PDEU, ker so imela ta generična podjetja dejanske in konkretne možnosti v zvezi s tem in so bila potencialni konkurenti družbe Lundbeck v času sklenitve spornih sporazumov (glej prvi tožbeni razlog zgoraj). | 437 | Accordingly, the Commission was not required also to examine the specific effects of the agreements at issue on competition and, in particular, whether, in the absence of those agreements, the generic undertakings would have entered the market without infringing one of Lundbeck’s patents, in order to be able to establish the existence of a restriction of competition by object, within the meaning of Article 101(1) TFEU, since those generic undertakings had real concrete possibilities in that respect and were potential competitors of Lundbeck at the time the agreements at issue were concluded (see the first plea in law above). |
| 438 | Sicer pa se v nasprotju z zatrjevanjem tožečih strank za to, da je mogoče določene sporazume obravnavati kot omejitev konkurence zaradi cilja, ne zahteva, da Komisija istovrstne sporazume že prej obsodi. Vloga izkušenj, ki jo je Sodišče omenilo v točki 51 zgoraj v točki 78 navedene sodbe CB/Komisija (EU:C:2014:2204), ne zadeva konkretne kategorije sporazuma v konkretnem sektorju, ampak opozarja na dejstvo, da so pri nekaterih oblikah dogovorov načeloma in glede na pridobljene izkušnje negativne posledice za konkurenco tako verjetne, da ni treba dokazati, da imajo take učinke v posameznem obravnavanem primeru. To, da je Komisija v preteklosti menila, da sporazum določene vrste zaradi svojega cilja ne omejuje konkurence, samo po sebi ne preprečuje, da bi v prihodnje po posamičnem in podrobnem preizkusu vsebine, namena in okvira spornih ukrepov menila drugače (glej v tem smislu zgoraj v točki 78 navedeno sodbo CB/Komisija, EU:C:2014:2204, točka 51; glej tudi sklepne predloge generalnega pravobranilca N. Wahla v zadevi CB/Komisija, C‑67/13 P, ZOdl., EU:C:2014:1958, točka 142, in sklepne predloge generalnega pravobranilca M. Watheleta v zadevi Toshiba Corporation/Komisija, C‑373/14 P, ZOdl., EU:C:2015:427, točka 74). | 438 | Moreover, contrary to what is claimed by the applicants, it is not necessary that the same type of agreement have already been censured by the Commission in order for them to constitute a restriction of competition by object. The role of experience, mentioned by the Court of Justice in paragraph 51 of the judgment in CB v Commission (cited in paragraph 78 above, EU:C:2014:2204), does not concern the specific category of an agreement in a particular sector, but rather refers to the fact that it is established that certain forms of collusion are, in general and in view of the experience gained, so likely to have negative effects on competition that it is not necessary to demonstrate that they had such effects in the particular case at hand. The fact that the Commission has not, in the past, considered that a certain type of agreement was, by its very object, restrictive of competition is therefore not, in itself, such as to prevent it from doing so in the future following an individual and detailed examination of the measures in question having regard to their content, purpose and context (see, to that effect, judgment in CB v Commission, cited in paragraph 78 above, EU:C:2014:2204, paragraph 51; the Opinion of Advocate General Wahl in CB v Commission, C‑67/13 P, ECR, EU:C:2014:1958, point 142, and the Opinion of Advocate General Wathelet in Toshiba Corporation v Commission, C‑373/14 P, ECR, EU:C:2015:427, point 74). |
| 439 | Tožeči stranki torej napačno trdita, da Komisija ni zadostno dokazala, da je mogoče sporne sporazume zaradi njihove vsebine in ciljev ob upoštevanju njihovega gospodarskega in pravnega okvira obravnavati kot dovolj škodljive za konkurenco (glej točko 343 zgoraj). | 439 | The applicants are therefore wrong in their submission that the Commission did not sufficiently establish that the agreements at issue could be regarded, by their content and their objectives, viewed in their economic and legal context, as sufficiently harmful to competition (see paragraph 343 above). |
| 440 | Prvi del je zato treba zavrniti. | 440 | The first part must therefore be rejected. |
| 2. Drugi del | 2. The second part |
| 441 | Tožeči stranki menita, da je Komisija napačno uporabila pravo z ugotovitvijo v izpodbijanem sklepu, da prenos vrednosti sam po sebi zadostuje za to, da je sporazum o patentni poravnavi omejevalen zaradi cilja. | 441 | The applicants maintain that the Commission errs in law when it finds in the contested decision that a value transfer is in itself sufficient to make a patent settlement agreement restrictive by object. |
| 442 | Izpostavljata, da je v izpodbijanem sklepu ugotovljeno, da „je treba upoštevati sredstva, ki jih imetniki patentov uporabljajo za obrambo svojih pravic“ (točka 641 obrazložitve), kar naj bi pomenilo, da je lahko sporazum že samo zaradi „sredstev“ protikonkurenčen zaradi cilja. Nobena predhodna zadeva pa naj ne bi kazala na to, da bi lahko zunanja spodbuda, bodisi v obliki ekonomskih ugodnosti bodisi fizičnega ali psihičnega pritiska, sama po sebi naredila sicer zakonit sporazum protikonkurenčen. Poleg tega, če zunanja spodbuda ne more upravičiti sicer protikonkurenčnega sporazuma, ne more niti sicer zakonitega sporazuma narediti protikonkurenčnega. Nazadnje, sodna praksa Sodišča naj bi potrjevala, da je treba protikonkurenčni cilj določenega sporazuma ugotavljati neodvisno od vsakršne presoje finančnih spodbud strankam. V izpodbijanem sklepu naj bi bil torej napačno pripisan odločilen pomen plačilu, čeprav je to v pravu konkurence nevtralno. | 442 | They observe that the contested decision states that the ‘means used by patent holders to defend their rights matter’ (recital 641), which means that the ‘means’ can in themselves render an agreement anticompetitive by object. However, there is no precedent that would indicate that an extraneous inducement, whether in the form of economic benefits or of physical or psychological pressure, can by itself make anticompetitive an agreement that would otherwise be lawful. Furthermore, if the existence of an extraneous inducement cannot justify what would otherwise be an anticompetitive agreement, it is similarly incapable of making an otherwise lawful agreement anticompetitive. Last, the case-law of the Court of Justice confirms that the anticompetitive object of an agreement must be established independently of any consideration of the parties’ financial incentives. The contested decision errs in that it attaches decisive importance to the payment, whereas the payment is neutral under competition law. |
| 443 | Komisija te trditve zavrača. | 443 | The Commission disputes those arguments. |
| 444 | Ker tožeči stranki v tem delu izpodbijata presojo Komisije o obrnjenih plačilih v izpodbijanem sklepu, je treba v zvezi s tem napotiti na preudarke o tem vprašanju pri drugem tožbenem razlogu (glej točke od 345 do 416 zgoraj). | 444 | In so far as, by this part, the applicants call into question the Commission’s assessment of the reverse payments in the contested decision, reference must be made, in that respect, to the considerations concerning that issue in the context of the second plea in law (see paragraphs 345 to 416 above). |
| 445 | Poleg tega je treba dodati, da sodna praksa, na katero se sklicujeta tožeči stranki in po kateri v zvezi z obstojem kršitve ni pomembno, ali je bila sklenitev sporazuma v poslovnem interesu strank, ki so tak sporazum sklenile (glej sodbo z dne 25. januarja 2007, Sumitomo Metal Industries in Nippon Steel/Komisija, C‑403/04 P in C‑405/04 P, ZOdl., EU:C:2007:52, točki 44 in 45 ter navedena sodna praksa), pomeni samo to, da stranke sporazuma ne morejo trditi, da je bil ta sporazum stroškovno najučinkovitejša rešitev za izognitev prepovedi iz člena 101(1) PDEU (glej točko 380 zgoraj). Ne nasprotuje pa temu, da Komisija pri ugotavljanju obstoja omejitve zaradi cilja upošteva vsebino sporazuma ter njegov namen in okvir sklenitve, kot je v obravnavani zadevi obstoj znatnih obrnjenih plačil. | 445 | In addition, it must be added that the case-law relied on by the applicants, according to which it does not matter, as far as the existence of the infringement is concerned, whether or not the conclusion of the agreement was in the commercial interests of the parties concluding that agreement (see, to that effect, judgment of 25 January 2007 in Sumitomo Metal Industries and Nippon Steel v Commission, C‑403/04 P and C‑405/04 P, ECR, EU:C:2007:52, paragraphs 44 and 45 and the case-law cited), means only that the parties to an agreement cannot maintain that that agreement was the most cost-effective option in order to circumvent the prohibition laid down in Article 101 TFEU (see paragraph 380 above). It does not, however, prevent the Commission from taking account of the content of an agreement, as well as its purpose and the context in which it was concluded — such as, in the present case, the presence of significant reverse payments — in order to establish the existence of a restriction by object. |
| 446 | Zato je treba zavrniti tudi drugi del. | 446 | Accordingly, the second part must also be rejected. |
| 3. Tretji del | 3. The third part |
| 447 | Tožeči stranki navajata, da je bilo v izpodbijanem sklepu napačno uporabljeno pravo, prvič, s tem, da ni bilo priznano, da so bili sporni sporazumi potrebni za uresničitev zakonitega cilja, in sicer zaščite in izvedbe patenta, in drugič, z napačno uporabo sodne prakse o „drugih zakonitih ciljih“ v obravnavani zadevi. | 447 | The applicants submit that the decision is vitiated by an error of law, first, in that it fails to recognise that the agreements at issue were necessary in order to achieve a legitimate objective, namely to protect and enforce a patent, and, secondly, in that it misapplies the case-law on ‘other legitimate objectives’ in the present case. |
| 448 | Tožeči stranki se sklicujeta na ustaljeno sodno prakso sodišč Unije, po kateri se z omejitvijo svobode ravnanja strank samodejno ne omejuje konkurenca, še posebej kadar je ta omejitev potrebna za uresničitev glavnega cilja, ki je z vidika konkurence nevtralen ali jo spodbuja. Zaščita naložb imetnika pravice intelektualne lastnine pa bi po njunem mnenju lahko bila tak zakonit cilj. | 448 | In the first place, the applicants rely on a consistent line of decisions of the Courts of the European Union in which it has been held that a restriction of the parties’ freedom of action does not automatically restrict competition, particularly if that restriction is necessary in order to pursue a primary object which is neutral as regards competition or promotes competition. The protection of the investment made by the holder of an intellectual property right may in the applicants’ submission constitute such a legitimate objective. |
| 449 | S spornimi sporazumi v obravnavani zadevi naj bi se uresničeval zakonit cilj zaščite in zagotovitve spoštovanja patentiranih postopkov družbe Lundbeck ter s tem varovala naložba družbe Lundbeck s preprečitvijo nepopravljive škode, ki bi jo povzročilo dajanje generičnih zdravil na trg. Poleg tega naj bi generična podjetja z njimi pridobila potreben čas za ugotovitev, ali so bili patenti družbe Lundbeck kršeni, ne da bi se izpostavljala stroškom in drugim izdatkom ali zamudnih sodnim postopkom. Tudi obseg in trajanje spornih sporazumov naj bi bila sorazmerna, ker je bil njihov edini namen preprečiti generičnim podjetjem trženje citaloprama, s katerim se kršijo patenti družbe Lundbeck, in ker je bilo njihovo trajanje ne nazadnje vezano na izid spora Lagap v Združenem kraljestvu, v katerem naj bi se obravnavali osnovni spori in ugotovilo, ali lahko družba Lundbeck še naprej upravičeno uveljavlja svoje patentirane postopke. | 449 | In the present case, the agreements at issue pursued the legitimate objective of protecting and enforcing Lundbeck’s process patents and thus safeguarding Lundbeck’s investment by preventing the irreparable harm resulting from the launch of generic medicinal products. The agreements also gave the generic undertakings the necessary time to determine whether Lundbeck’s patents were infringed, without being obliged to incur the costs or other burdens or suffer the delays inherent in litigation. In addition, the scope and duration of the agreements at issue were proportionate, since the agreements were intended solely to prevent the generic undertakings from marketing citalopram that infringed Lundbeck’s patents, and their duration was ultimately linked to the outcome of the Lagap litigation in the United Kingdom, which was intended to address the underlying disputes and to establish whether Lundbeck would still have a reason to enforce its process patents. |
| 450 | Komisija te trditve zavrača. | 450 | The Commission disputes those arguments. |
| 451 | V zvezi s tem je treba spomniti, da če določena transakcija ali dejavnost zaradi svoje nevtralnosti ali pozitivnega učinka na konkurenco ne spada na področje uporabe načela prepovedi iz člena 101(1) PDEU, tudi omejitev poslovne samostojnosti enega ali več udeležencev te transakcije ali dejavnosti ne spada na področje uporabe omenjenega načela, če je ta omejitev objektivno nujna za izvršitev te transakcije ali dejavnosti in sorazmerna s cilji ene ali druge (sodba z dne 11. septembra 2014, MasterCard in drugi/Komisija, C‑382/12 P, ZOdl., EU:C:2014:2201, točka 89 in navedena sodna praksa). | 451 | It must be recalled that, according to the case-law, if a given operation or activity is not covered by the prohibition rule laid down in Article 101(1) TFEU, owing to its neutrality or positive effect in terms of competition, a restriction of the commercial autonomy of one or more of the participants in that operation or activity is not covered by that prohibition rule either if that restriction is objectively necessary to the implementation of that operation or that activity and proportionate to the objectives of one or the other (see judgment of 11 September 2014 in MasterCard and Others v Commission, C‑382/12 P, ECR, EU:C:2014:2201, paragraph 89 and the case-law cited). |
| 452 | Kadar namreč take omejitve ni mogoče ločiti od glavne transakcije ali dejavnosti brez ogrožanja njenega obstoja in ciljev, je treba preveriti skladnost te omejitve s členom 101 PDEU skupaj s skladnostjo glavne transakcije ali dejavnosti, do katere je v pomožnem razmerju, in to čeprav se lahko za enako omejitev, če se obravnava ločeno, na prvi pogled zdi, da spada na področje uporabe načela prepovedi iz člena 101(1) PDEU (zgoraj v točki 451 navedena sodba MasterCard in drugi/Komisija, EU:C:2014:2201, točka 90). | 452 | Where it is not possible to dissociate such a restriction from the main operation or activity without jeopardising its existence and aims, it is necessary to examine the compatibility of that restriction with Article 101 TFEU in conjunction with the compatibility of the main operation or activity to which it is ancillary, even though, taken in isolation, such a restriction may appear on the face of it to be covered by the prohibition rule in Article 101(1) TFEU (judgment in MasterCard and Others v Commission, cited in paragraph 451 above, EU:C:2014:2201, paragraph 90). |
| 453 | Kadar je treba ugotoviti, ali se lahko protikonkurenčna omejitev izogne prepovedi, določeni v členu 101(1) PDEU, ker je pomožna glavni transakciji, ki ni protikonkurenčna, je treba raziskati, ali izvršitev te transakcije brez zadevne omejitve ne bi bila mogoča. Zaradi dejstva, da bi bila omenjena transakcija brez zadevne omejitve zgolj težje izvedljiva oziroma manj dobičkonosna, se zadevna omejitev ne more šteti za „objektivno nujno“, kar se zahteva za njeno opredelitev kot pomožno. Taka razlaga bi namreč privedla do tega, da bi razširila ta pojem na omejitve, ki niso strogo nujne za izvršitev glavne transakcije. To pa bi ogrozilo učinkovitost prepovedi, določene v členu 101(1) PDEU (zgoraj v točki 451 navedena sodba MasterCard in drugi/Komisija, EU:C:2014:2201, točka 91). | 453 | Where it is a matter of determining whether an anticompetitive restriction can escape the prohibition laid down in Article 101(1) TFEU because it is ancillary to a main operation that is not anticompetitive in nature, it is necessary to inquire whether that operation would be impossible to carry out in the absence of the restriction in question. The fact that that operation is simply more difficult to implement or even less profitable without the restriction concerned cannot be deemed to give that restriction the ‘objective necessity’ required in order for it to be classified as ancillary. Such an interpretation would effectively extend that concept to restrictions which are not strictly indispensable to the implementation of the main operation. Such an outcome would undermine the effectiveness of the prohibition laid down in Article 101(1) TFEU (judgment in MasterCard and Others v Commission, cited in paragraph 451 above, EU:C:2014:2201, paragraph 91). |
| 454 | Pogoj nujnosti omejitve torej zahteva dvojno proučitev. Po eni strani je namreč treba proučiti, ali je omejitev objektivno potrebna za izvedbo glavne transakcije, in po drugi, ali je sorazmerna glede nanjo (glej zgoraj v točki 98 navedeno sodbo E.ON Ruhrgas in E.ON/Komisija, EU:T:2012:332, točka 64 in navedena sodna praksa). | 454 | The condition that a restriction be necessary therefore implies a two-fold examination. It is necessary to establish, first, whether the restriction is objectively necessary for the implementation of the main operation and, secondly, whether it is proportionate to it (see judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 98 above, EU:T:2012:332, paragraph 64 and the case-law cited). |
| 455 | Poleg tega je treba poudariti, da če obstoja pravila razumne presoje ni mogoče dopustiti v konkurenčnem pravu Unije, potem bi bilo pogoj objektivne nujnosti v okviru opredelitve pomožnih omejitev zmotno razlagati v smislu, kot da zahteva tehtanje učinkov, ki govorijo v prid in proti konkurenčnosti nekega sporazuma (glej v tem smislu zgoraj v točki 98 navedeno sodbo E.ON Ruhrgas in E.ON/Komisija, EU:T:2012:332, točka 65 in navedena sodna praksa). | 455 | Moreover, it must be emphasised that inasmuch as the existence of a rule of reason in EU competition law cannot be upheld, it would be wrong, when classifying ancillary restrictions, to interpret the requirement for objective necessity as implying a need to weigh the pro and anticompetitive effects of an agreement (see, to that effect, judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 98 above, EU:T:2012:332, paragraph 65 and the case-law cited). |
| 456 | V obravnavani zadevi tožeči stranki trdita, da so omejitve poslovne samostojnosti generičnih podjetij pomožne v razmerju do uresničitve glavnega cilja, ki je varstvo njunih pravic intelektualne lastnine. | 456 | In the present case, the applicants submit that the restrictions on the generic undertakings’ commercial autonomy were ancillary to the achievement of the main object, which was the protection of their intellectual property rights. |
| 457 | Take utemeljitve ni mogoče sprejeti. | 457 | That argument cannot be upheld. |
| 458 | Tožeči stranki namreč, prvič, nista dokazali, da so bile omejitve, dogovorjene v spornih sporazumih, objektivno nujne za varstvo njunih pravic intelektualne lastnine v smislu zgoraj navedene sodne prakse. Svoje pravice bi lahko na eni strani zaščitili z vložitvijo tožb pri pristojnih nacionalnih sodiščih ob kršitvi njunih patentov. Na drugi strani – kot je Komisija navedla v točki 638 in naslednjih obrazložitve izpodbijanega sklepa – obstaja več načinov poravnave patentnega spora brez dogovora o omejitvah za vstop generikov na trg z obrnjenimi plačili, ki približno ustrezajo pričakovanim donosom generikov ob vstopu na trg (glej točki 334 in 411 zgoraj). Tožeči stranki torej nista dokazali, da so bile omejitve objektivno nujne za uresničitev zatrjevanega cilja, torej zagotovitve spoštovanja njunih pravic intelektualne lastnine. | 458 | First, the applicants have not demonstrated that the restrictions set out in the agreements at issue were objectively necessary in order to protect their intellectual property rights, within the meaning of the abovementioned case-law. They could have protected those rights by bringing actions before the competent national courts in the event that their patents were infringed. Furthermore, as the Commission indicated in recital 638 et seq. of the contested decision, there are numerous ways of settling a patent dispute without agreeing to restrictions on the market entry of generic undertakings, by means of reverse payments corresponding approximately to the profits expected by those undertakings if they had entered the market (see paragraphs 334 and 411 above). The applicants have therefore failed to establish that those restrictions were objectively necessary for the achievement of the alleged objective, namely protecting their intellectual property rights. |
| 459 | Drugič, spomniti je treba, da v skladu s sodno prakso določen sporazum ni izvzet iz prava konkurence samo zato, ker se nanaša na patent ali se želi z njim patentni spor rešiti s poravnavo, in da je mogoče šteti, da ima sporazum omejevalen namen, tudi če njegov edini namen ni omejevanje konkurence, ampak sledi tudi drugim, legitimnim ciljem (glej točko 427 zgoraj in navedeno sodno prakso). To, da je lahko šlo za stroškovno najučinkovitejšo ali najmanj tvegano rešitev, nikakor ne izključuje uporabe člena 101(1) PDEU (točka 380 zgoraj). | 459 | Secondly, it must be recalled that, according to the case-law, an agreement is not exempt from competition law merely because it concerns a patent or is intended to settle a patent dispute, and it may be regarded as having a restrictive object even if it does not have the restriction of competition as its sole aim but also pursues other legitimate objectives (see paragraph 427 above and the case-law cited). The fact that it may have been the most cost-effective or least risky option from a commercial perspective in no way precludes the application of Article 101 TFEU (paragraph 380 above). |
| 460 | Tretjič, tudi če bi bilo v spornih sporazumih dogovorjene omejitve mogoče obravnavati kot objektivno nujne za uresničitev po zatrjevanju tožečih strank glavnega cilja, to je zagotovitve spoštovanja njunih pravic intelektualne lastnine, pa še vedno niso sorazmerne z uresničitvijo navedenega cilja. V nasprotju z zatrjevanjem tožečih strank se s spornimi sporazumi ni rešil noben patentni spor, ker so določali le, da bodo generična podjetja proti plačilu za določen čas ostala zunaj trga citaloprama, določali niso niti tega, da lahko po poteku tega časa vstopijo na trg, ne da bi bila izpostavljena tožbam družbe Lundbeck zaradi kršitev. Poleg tega je obseg omejitev iz navedenih sporazumov pogosto presegal obseg patentov družbe Lundbeck (glej šesti tožbeni razlog spodaj). Nazadnje, tožeči stranki napačno trdita, da je bila zadeva Lagap v Združenem kraljestvu ključna za rešitev sporov z generičnimi podjetji, ker so bili sporazumi GUK za Združeno kraljestvo, Arrow UK, danski Arrow, Alpharma in Ranbaxy – kot je Komisija navedla v točki 683 in naslednjih obrazložitve izpodbijanega sklepa – vsi sklenjeni preden je družba Lundbeck 14. oktobra 2002 v Združenem kraljestvu zoper družbo Lagap vložila tožbo zaradi kršitev. Kar zadeva edini pozneje sklenjen sporazum, to je sporazum GUK za EGP, spor z družbo Lagap dejansko ni bil upošteven, ker je bila zadevna AFU v postopku zoper družbo Lagap, ki je temeljila na postopku Matrix II, drugačna od AFU družbe Natco, iz katere je bil proizveden generični citalopram, ki ga je podjetje Merck (GUK) nameravalo tržiti (točka 687 obrazložitve izpodbijanega sklepa). | 460 | Thirdly, in any event, even if the restrictions agreed under the agreements at issue could be regarded as objectively necessary for the achievement of the main objective alleged by the applicants, namely protecting their intellectual property rights, they are nevertheless disproportionate to the achievement of that objective. Contrary to the applicants’ assertions, the agreements at issue did not resolve any patent dispute, since they provided only that the generic undertakings would stay out of the citalopram market for a certain period, in return for payment, without even providing that at the end of that period they could enter that market without having to face infringement actions from Lundbeck. Moreover, the scope of the restrictions contained in those agreements often went beyond the scope of Lundbeck’s patents (see the sixth plea in law below). Lastly, the applicants wrongly assert that the Lagap case in the United Kingdom was a key case enabling it to resolve the disputes with the generic undertakings, since, as the Commission points out in recital 683 et seq. of the contested decision, the GUK United Kingdom, Arrow UK, Arrow Danish, Alpharma and Ranbaxy agreements were all concluded before Lundbeck had brought an infringement action against Lagap in the United Kingdom, on 14 October 2002. As regards the only agreement concluded subsequently, namely the GUK EEA agreement, the litigation with Lagap was not really relevant, since the API at issue in the Lagap trial, based on the Matrix II process, was different from the Natco API, on the basis of which the generic citalopram that Merck (GUK) intended to sell was produced (recital 687 of the contested decision). |
| 461 | Tožeči stranki torej napačno trdita, da so bile v spornih sporazumih dogovorjene omejitve nujno potrebne in sorazmerne za zaščito njunih pravic intelektualne lastnine. | 461 | The applicants’ assertion that the restrictions contained in the agreements at issue were objectively necessary and proportional in order to protect their intellectual property rights is therefore wrong. |
| 462 | Dalje, tožeči stranki menita, da je v izpodbijanem sklepu napačno uporabljena sodna praksa o drugih zakonitih ciljih v obravnavani zadevi. V njem naj bi bilo namreč navedeno, da to, da ima sporazum lahko druge povsem zakonite cilje, ne onemogoča ugotovitve obstoja omejitve zaradi cilja. Vendar naj bi se zadeve, na katere se je Komisija sklicevala v podporo tej trditvi, nanašale na položaje, v katerih je bilo mogoče zakoniti cilj doseči brez omejevanja konkurence, medtem ko so bili v obravnavani zadevi sporni sporazumi nujni za zagotovitev spoštovanja patentov družbe Lundbeck. | 462 | In the second place, the applicants maintain that, in the contested decision, the Commission misapplies the case-law on ‘other legitimate objectives’ in the present case. The Commission asserts in the contested decision that the fact that an agreement may also have other, entirely legitimate objectives does not preclude the possibility of finding a restriction by object. However, according to the applicants, the cases cited by the Commission in support of that assertion relate to situations where the legitimate objective could have been achieved without restricting competition, whereas in the present case the agreements at issue were necessary in order to ensure compliance with Lundbeck’s patents. |
| 463 | Intervenient podpira trditve tožečih strank in prav tako meni, da je Komisija napačno uporabila pravni preizkus za uporabo člena 101(1) PDEU. Meni, da sodna praksa Sodišča temelji na preizkusu „objektivne nujnosti“, s katerim se ugotavlja, ali se člen 101 PDEU uporablja ali ne. Zato bi morala Komisija analizirati, ali je bila poravnava sklenjena v dobri veri za rešitev resničnega patentnega spora in ali so bile dogovorjene omejitve nujne in sorazmerne temu zakonitemu cilju. | 463 | The intervener supports the applicants’ arguments and also maintains that the Commission misapplied the legal test for the application of Article 101(1) TFEU. In its submission, the case-law of the Court of Justice is based on an ‘objective necessity’ test which is applied in order to determine whether Article 101 TFEU is applicable. The Commission ought therefore to have examined whether a settlement agreement had been concluded in good faith in order to resolve a genuine patent dispute and whether the restrictions agreed were necessary and proportionate to that legitimate objective. |
| 464 | V zvezi s tem je treba ugotoviti, da v nasprotju s trditvami tožečih strank in intervenienta Komisija ni napačno uporabila prava z uporabo sodne prakse o drugih zakonitih ciljih v obravnavani zadevi (glej točko 427 zgoraj in navedeno sodno prakso) in z zavrnitvijo trditev tožečih strank v zvezi s tem v točki 653 obrazložitve izpodbijanega sklepa, ker so tudi te trditve temeljile na napačni premisi, da po zatrjevanju tožečih strank zakonitega cilja varovanja njunih pravic intelektualne lastnine ni bilo mogoče doseči brez omejitve konkurence (glej točke od 458 do 461 zgoraj). | 464 | It must be stated in that respect that, contrary to the assertions of the applicants and the intervener, the Commission did not commit an error of law in applying the case-law on other legitimate objectives in the present case (see paragraph 427 above and the case-law cited) and in rejecting the applicants’ arguments in that respect, in recital 653 of the contested decision, since those arguments were also based on the erroneous premiss that the legitimate objective alleged by the applicants, namely protecting their intellectual property rights, could not have been achieved without restricting competition (see paragraphs 458 to 461 above). |
| 465 | Zato je treba tretji del zavrniti. | 465 | Accordingly, the third part must be rejected. |
| 4. Četrti del | 4. The fourth part |
| 466 | Tožeči stranki menita, da je bilo v sklepu napačno uporabljeno pravo s tem, da v njem ni bilo priznano, da scenarij v nasprotju z dejstvi v obravnavani zadevi izključuje možnost ugotovitve omejitve konkurence zaradi cilja. | 466 | The applicants maintain that the decision is vitiated by an error of law in that it does not recognise that the counterfactual scenario in the present case precludes the possibility of a finding of a restriction of competition by object. |
| 467 | Trdita, da se v izpodbijanem sklepu zanemarja dejstvo, da generična podjetja tudi brez spornih sporazumov ne bi prodajala neponarejenega citaloprama. Iz ustaljene sodne praksa pa naj bi izhajalo, da je splošno merilo za presojo, ali je cilj ali učinek določenega sporazuma omejevanje konkurence, kako bi delovala konkurenca na upoštevnem trgu, če zadevnega sporazuma ne bi bilo. Najmanjši dvom v obstoj konkurence brez sporazuma bi torej zadostoval za izključitev kršitve člena 101 PDEU. Poleg tega naj bi bila odprava negotovosti značilna za vsakršno poravnavo, v izpodbijanem sklepu pa naj bi se priznavalo, da je možno, da se s poravnavami, s katerimi se preloži vstop na trg, v določenih primerih ne krši člen 101 PDEU. | 467 | They submit that the contested decision disregards the fact that, even without the agreements at issue, the generic undertakings would not have sold non-infringing citalopram. It has consistently been held that the general criterion for deciding whether an agreement has the object or the effect of restricting competition is how competition would have operated in the market in question in the absence of that agreement. If there is the slightest doubt that competition would have existed in the absence of the agreement that is enough to preclude any infringement of Article 101 TFEU. Furthermore, the removal of uncertainty is inherent in any settlement agreement and the contested decision recognises that settlement agreements which delay market entry may in certain cases not infringe Article 101 TFEU. |
| 468 | Resničnih možnosti za vstop na enega ali več trgov v EGP v času trajanja spornih sporazumov, ki se navajajo v izpodbijanem sklepu, naj ne bi bilo, vsekakor pa naj bi bile to samo možnosti, kar pomeni najmanj to, da ni bilo gotovo, da bi generična podjetja brez teh sporazumov prodajala neponarejeni citalopram. Po mnenju tožečih strank naj namreč generična podjetja ne bi imela nobenega DZP, in tudi če bi svoje ponarejene generične proizvode lahko dala na trg, bi zoper njih zahtevali prepovedi. Poleg tega so se lahko ta podjetja odločila za to, da ostanejo zunaj trga ali da z njega izstopijo, zato da bi se izognila sporu z družbo Lundbeck. Sicer pa naj bi več generičnih podjetij dejavno nadaljevalo s pripravami za vstop na trg, med drugim z nadaljnjimi raziskavami v zvezi z neponarejenim citalopramom, sporni sporazumi pa naj jim tudi ne bi preprečevali izpodbijanja veljavnosti patentov družbe Lundbeck. | 468 | The realistic prospects referred to in the contested decision of entering one or more markets in the EEA during the period covered by the agreements at issue are unfounded and in any event are mere possibilities, which means at the very least that it was not certain that, in the absence of those agreements, the generic undertakings would have sold non-infringing citalopram. In fact, according to the applicants, the generic undertakings did not have an MA and, on the assumption that they could have launched their infringing generic products, they would have been faced with injunctions sought by the applicants. In addition, those undertakings could have chosen to stay out of the market or to exit the market in order to avoid litigation with Lundbeck. Furthermore, a number of generic undertakings continued to prepare for their market entry, in particular by continuing their research into non-infringing citalopram, and the agreements at issue did not prevent them from challenging the validity of Lundbeck’s patents either. |
| 469 | Komisija te trditve zavrača. | 469 | The Commission disputes those arguments. |
| 470 | Prvič, v delu v katerem tožeči stranki skušata ovreči ugotovitev, da so bila generična podjetja v času sklenitve spornih sporazumov potencialni konkurenti družbe Lundbeck, in ker so bile te trditve zavrnjene že zgoraj v okviru prvega tožbenega razloga, je treba napotiti na navedbe v zvezi s tem. | 470 | First, inasmuch as, by their arguments, the applicants appear to seek to call into question the conclusion that the generic undertakings were potential competitors of Lundbeck at the time the agreements at issue were concluded, those arguments were already rejected in the context of the first plea in law above and reference must be made to the considerations set out in that respect. |
| 471 | Poleg tega je treba spomniti, da je člen 101 PDEU namenjen varovanju tako potencialne kot dejanske konkurence med podjetji na trgu (glej točko 99 zgoraj). Tožeči stranki torej ne moreta uspešno ponovno trditi, da je povsem negotovo, da bi generična podjetja dejansko vstopila na trg med trajanjem spornih sporazumov, ker se s tako utemeljitvijo zanemarja razlikovanje med dejansko in potencialno konkurenco. | 471 | Moreover, it must be recalled that Article 101 TFEU is intended to protect potential competition as well as actual competition between undertakings on the market (see paragraph 99 above). It is thus to no avail that the applicants again submit that there is no certainty that the undertakings would have actually entered the market during the term of the agreements at issue, since that argument disregards the distinction between actual competition and potential competition. |
| 472 | Drugič, v delu, v katerem tožeči stranki trdita, da bi morala Komisija proučiti scenarij, nasproten dejanskemu stanju v obravnavani zadevi, je treba spomniti, da je morala Komisija pri omejitvah konkurence zaradi cilja dokazati samo to, da so sporni sporazumi dovolj škodljivi za konkurenco glede na vsebino njihovih določb, cilje, ki se želijo z njimi doseči, ter pravni in gospodarski okvir, v katerega so umeščeni, ni pa ji treba analizirati njihovih učinkov (točka 341 zgoraj). | 472 | Secondly, inasmuch as the applicants submit that the Commission should have examined the counter factual scenario in the present case, it must be recalled that, as regards restrictions on competition by object, the Commission was only required to demonstrate that the agreements at issue revealed a sufficient degree of harm to competition, in view of the content of their provisions, the objectives that they are intended to achieve and the economic and legal context of which they formed part, without being required, however, to examine their effects (paragraph 341 above). |
| 473 | Analiza hipotetičnega scenarija v nasprotju z dejstvi bi bila – poleg tega da bi bila težko izvedljiva, ker bi morala Komisija rekonstruirati dogodke, ki bi se zgodili brez spornih sporazumov, cilj teh sporazumov pa je bil ravno preložitev vstopa generičnih podjetij na trg (glej točki 138 in 139 zgoraj) – bolj presoja učinkov spornih sporazumov na trg kot objektivna presoja zadostne škodljivosti teh sporazumov za konkurenco. Taka presoja učinkov pa se ne zahteva v okviru analize obstoja omejitev konkurence zaradi cilja (točka 341 zgoraj). | 473 | The examination of a hypothetical counterfactual scenario — besides being impracticable since it requires the Commission to reconstruct the events that would have occurred in the absence of the agreements at issue, whereas the very purpose of those agreements was to delay the market entry of the generic undertakings (see paragraphs 138 and 139 above) — is more an examination of the effects of agreements at issue on the market than an objective examination of whether they are sufficiently harmful to competition. Such an examination of effects is not required in the context of an analysis based on the existence of a restriction of competition by object (paragraph 341 above). |
| 474 | Zato tudi če nekatera generična podjetja ne bi vstopila na trg med trajanjem spornih sporazumov zaradi tožb zaradi kršitev, ki bi jih vložila družba Lundbeck, ali zaradi nezmožnosti pridobitve DZP v dovolj kratkem roku, je pomembno to, da so ta podjetja v času sklenitve spornih sporazumov z družbo Lundbeck imela dejanske in konkretne možnosti za vstop na trg in s tem vršenje konkurenčnega pritiska nanjo. Ta konkurenčni pritisk pa je bil med trajanjem spornih sporazumov onemogočen, kar je samo po sebi omejitev konkurence zaradi cilja v smislu člena 101(1) PDEU. | 474 | Accordingly, even if some generic undertakings would not have entered the market during the term of the agreements at issue, as a result of infringement actions brought by Lundbeck, or because it was impossible to obtain an MA within a sufficiently short period, what matters is that those undertakings had real concrete possibilities of entering the market at the time the agreements at issue were concluded with Lundbeck, with the result that they exerted competitive pressure on the latter. That competitive pressure was eliminated for the term of the agreements at issue, which constitutes, by itself, a restriction of competition by object, for the purpose of Article 101(1) TFEU. |
| 475 | Čeprav je res, da je cilj poravnav pogosto zmanjšanje negotovosti, značilnih za sodne postopke, pa te poravnave niso izvzete iz uporabe prava konkurence (glej točko 427 zgoraj). Poleg tega – kot je Komisija ugotovila v izpodbijanem sklepu – so še posebej problematične, kadar določajo plačilo potencialnih konkurentov za to, da ti za določen čas ostanejo zunaj trga, ne rešijo pa nobenega osnovnega patentnega spora, kakršen je v obravnavani zadevi. | 475 | Although it is true that settlements are often intended to reduce the uncertainty inherent in litigation, such settlements are not exempt from the application of competition law (see paragraph 427 above). In addition, as the Commission found in the contested decision, settlements are particularly problematic when they are intended to pay potential competitors to stay out of the market for a certain period, without, however, resolving the underlying patent dispute, as in the present case. |
| 476 | Zato je Komisija pravilno menila, da sporni sporazumi spadajo med sporazume med konkurenti o izključitvi s trga in da imajo lahko negativne učinke na konkurenco, ne da bi bilo treba pri uporabi člena 101(1) PDEU dokazati, da imajo take učinke. | 476 | Accordingly, the Commission rightly considered that the agreements at issue were akin to market exclusion agreements between competitors and that they were liable to have negative effects on competition, without it being necessary, for the purpose of Article 101(1) TFEU, to demonstrate that they had had such effects. |
| 477 | Zato je treba zavrniti tudi četrti del in s tem tretji tožbeni razlog v celoti. | 477 | Consequently, the fourth part must also be rejected, as, accordingly, must the third plea in law in its entirety. |
| E – Četrti tožbeni razlog: napačna uporaba prava in neobrazloženost pri zavrnitvi preizkusa obsega patenta kot bistvenega standarda presoje sporazumov o patentni poravnavi po členu 101(1) PDEU | E – The fourth plea in law, alleging an error of law and a failure to state reasons in rejecting the scope-of-the-patent test as the key standard in assessing patent settlement agreements under Article 101(1) TFEU |
| 478 | Tožeči stranki menita, da Komisija napačno ni priznala, da se člen 101(1) PDEU ne uporablja za sporazume z omejitvami, ki so značilne za izvrševanje pravic, ki jih patent daje svojemu imetniku, in je napačno navedla, da se navedena določba verjetno uporablja za sporazume z omejitvami, ki presegajo obseg tega patenta. Po njunem mnenju je bilo v izpodbijanem sklepu, prvič, napačno uporabljeno pravo, ker ni bil upoštevan preizkus obsega patenta kot standard upoštevne presoje sporazumov o patentnih poravnavah po členu 101(1) PDEU, in drugič, utemeljitev v izpodbijanem sklepu za zavrnitev tega preizkusa ni jasna in logična ter je v nasprotju s ključnimi utemeljitvami v preostalem delu izpodbijanega sklepa. | 478 | The applicants maintain that the Commission is wrong not to accept that agreements containing restrictions which correspond to those inherent in the exercise of the rights which a patent confers on its holder are not covered by Article 101(1) TFEU and is wrong to suggest that agreements imposing restrictions which go beyond the scope of the patent are likely to be caught by that provision. In their submission, first, the contested decision is vitiated by an error of law in that it rejects the ‘scope of the patent’ test as the relevant standard for assessing patent settlement agreements under Article 101(1) TFEU and, secondly, the argument used by the Commission in the contested decision in order to reject that test is unclear, illogical and contradicted by the key reasoning underlying the rest of the contested decision. |
| 1. Prvi del | 1. The first part |
| 479 | Na prvem mestu, tožeči stranki menita, da se s pogodbenimi omejitvami znotraj časovnega, teritorialnega in materialnega obsega pravic imetnika patenta ne krši pravo konkurence, ker so te omejitve podobne tistim, ki so značilne za osnovni patent, ne glede na to, ali poravnava zajema prenos vrednosti proizvajalca originalnih zdravil v korist generičnega proizvajalca. | 479 | In the first place, the applicants claim that the contractual restrictions falling within the patent-holder’s temporal, territorial and material rights do not infringe competition law, because those restrictions are analogous to the restrictions inherent in the underlying patent, irrespective of whether the settlement agreement also involves a value transfer from the originator undertaking to the generic manufacturer. |
| 480 | Tak pogoj naj bi bil v skladu z načelom o domnevi veljavnosti patentov dokler se izrecno ne razglasijo za neveljavne. Sodišče naj bi v zgoraj v točki 119 navedeni sodbi Windsurfing (EU:C:1986:75) priznalo, da je vsaka določba v zvezi s proizvodi, varovanimi s patentom, utemeljena z varstvom pravice intelektualne lastnine. Obseg patenta naj bi bil torej upošteven pri presoji kršitve člena 101 PDEU. | 480 | Such a condition is consistent with the principle that patents are presumed valid until expressly declared invalid. In the Windsurfing judgment, cited in paragraph 119 above (EU:C:1986:75), the Court of Justice accepted that any clause relating to products covered by a patent was justified on the ground that it protected an intellectual property right. The scope of the patent is therefore relevant for the purposes of determining whether there has been an infringement of Article 101 TFEU. |
| 481 | Na drugem mestu, tožeči stranki menita, da je treba vsako poravnavo povezovati s sporom „v dobri veri“ med strankama sporazuma, ki se nanaša na veljavnost in/ali kršitev patenta. Taki sporazumi naj bi bili sami po sebi zakoniti in uporabni in bi bili lahko podvrženi nadzoru konkurence, samo če bi bil osnovni spor fiktiven. | 481 | In the second place, the applicants maintain that every settlement agreement must be linked to a ‘bona fide’ dispute between the parties to the agreement concerning the validity and/or the infringement of a patent. Such agreements are intrinsically lawful and useful and would be subject to antitrust scrutiny only if the underlying dispute were fictitious. |
| 482 | Na področju poravnav v zvezi s patenti in generičnimi zdravili pa bi bilo treba spor opredeliti kot resničen, kadar na eni strani ni dokazano, da je imetnik patenta vedel ali bil trdno prepričan, da patent ni veljaven, na drugi strani pa ta imetnik nima zadostnih dokazov za trditev, da se z generičnimi zdravili krši njegov patent. Če imetnik patenta samo dvomi v njegovo veljavnost, ti dvomi – ki odražajo negotovost, značilno za rešitev kakršnega koli spora – ne vplivajo dovolj na resničnost spora in na nezakonitost sporazuma o poravnavi. Zato izjave, kakršne se večkrat navajajo v izpodbijanem sklepu in so bile izrečene več kot leto in pol po sklenitvi spornih sporazumov, po katerih naj bi eden od zaposlenih pri družbi Lundbeck ocenjeval, da obstaja šestdesetodstotno tveganje, da bi sodišča Združenega kraljestva razveljavila patent za kristalizacijo, nikakor ne morejo biti upoštevane kot dokaz, da je družba Lundbeck menila, da patent za kristalizacijo ni veljaven, ali da ni nikakršne možnosti za to, da ga uveljavi na sodišču. | 482 | As regards settlement agreements concerning patents and generic medicinal products, a dispute must be classified as authentic where, first, it is not established that the patent-holder knew or was firmly persuaded that the patent was invalid and, secondly, the patent-holder had sufficient evidence to claim that the generic medicinal products infringed its patent. If a patent-holder merely had doubts as to the validity of the patent, those doubts, which reflect the uncertainty inherent in the outcome of any dispute, would not be sufficient to affect the genuine nature of the dispute and to render a settlement agreement unlawful. Accordingly, statements such as those repeatedly cited in the contested decision, made more than one and a half years after the conclusion of the agreements at issue, and suggesting that a Lundbeck employee had estimated at 60% the chances of the crystallisation patent being declared invalid by the United Kingdom courts, cannot be taken to indicate that Lundbeck believed that the crystallisation patent was invalid or that it had no chance of having it enforced before a court. |
| 483 | Na tretjem mestu, tožeči stranki zato menita, da je preizkus obsega patenta edini ustrezen standard. Najprej, tak preizkus naj bi omogočal vzpostavitev ustreznega ravnovesja med pravom konkurence in patentnim pravom. Dalje, odgovarjal naj bi na skrbi Komisije v zvezi s patentnimi poravnavami, ker lahko generično podjetje, ki sklene tak sporazum, vstopi na trg tako, da ne krši materialnega, časovnega ali teritorialnega obsega zadevnega patenta. Nazadnje, ne bi naj imel pomanjkljivosti, ki jih ima preizkus, uporabljen v izpodbijanem sklepu. | 483 | In the third place, the applicants argue, therefore, that the ‘scope of the patent’ test is the only appropriate standard. First of all, that test strikes a reasonable balance between competition law and patent law. Furthermore, it meets the Commission’s concerns in relation to patent settlement agreements, since a generic undertaking concluding such an agreement is able, in particular, to enter the market in a way that does not infringe the material, temporal or territorial scope of the patent at issue. Lastly, it is not tainted by the flaws that vitiate the test applied in the contested decision. |
| 484 | Na četrtem mestu, po mnenju tožečih strank naj nobeden od spornih sporazumov ne bi kršil člena 101 PDEU, ker vsi izpolnjujejo, na eni strani, pogoj, da so znotraj obsega patenta, ker pogodbene omejitve veljajo samo za ponarejena zdravila in ne presegajo teritorialnega in časovnega obsega patentiranih postopkov družbe Lundbeck, in na drugi strani pogoja resničnosti spora, ker noben dokaz ne kaže na to, da je družba Lundbeck menila, da njeni patenti niso veljavni, poleg tega pa je imela znanstvene dokaze za to, da so generična podjetja kršila njene patentirane postopke. | 484 | In the fourth place, according to the applicants, none of the agreements at issue infringes Article 101 TFEU, because they all satisfy the ‘scope of the patent’ condition, since the contractual restrictions were limited to infringing medicinal products and did not exceed the territorial and temporal scope of Lundbeck’s process patents, and also satisfy the ‘genuine dispute’ condition, since there is no evidence to suggest that Lundbeck considered that its patents were invalid and since, in addition, Lundbeck had scientific evidence that the generic undertakings infringed its process patents. |
| 485 | Komisija te trditve zavrača. | 485 | The Commission disputes those arguments. |
| 486 | Najprej je treba opozoriti na to, da člen 101(1) PDEU v skladu s sodno prakso ne razlikuje med sporazumi s ciljem končanja spora in tistimi z drugimi cilji (zgoraj v točki 430 navedena sodba Bayer in Maschinenfabrik Hennecke, EU:C:1988:448, točka 15). Čeprav člen 101 PDEU ne vpliva na pravice, ki jih priznava zakonodaja države članice na področju intelektualne lastnine, pa se prepovedi iz tega člena lahko uporabljajo za pogoje njihovega izvrševanja. To je lahko vsakokrat, kadar se zdi, da je izvrševanje take pravice predmet, sredstvo ali posledica omejevalnega sporazuma (zgoraj v točki 117 navedena sodba Centrafarm in de Peijper, EU:C:1974:115, točki 39 in 40). | 486 | It must be recalled, first of all, that, according to the case-law, Article 101(1) TFEU makes no distinction between agreements whose object is to put an end to litigation and those concluded with other aims in mind (judgment in Bayer and Maschinenfabrik Hennecke, cited in paragraph 427 above, EU:C:1988:448, paragraph 15). Although the rights recognized under the industrial property legislation of a Member State are not affected by Article 101 TFEU, the circumstances in which they are exercised may nevertheless fall within the scope of the prohibitions laid down in that article. This may be the case whenever the exercise of such a right appears to be the object, the means or the consequence of an agreement (judgment in Centrafarm and de Peijper, cited in paragraph 117 above, EU:C:1974:114, paragraphs 39 and 40). |
| 487 | Čeprav je posebni cilj industrijske lastnine resda predvsem zagotoviti imetniku, da se nagradi ustvarjalno prizadevanje izumitelja, izključno pravico do uporabe izuma za izdelavo industrijskih proizvodov in njihovo prvo dajanje v promet bodisi neposredno bodisi s podelitvijo licenc tretjim osebam, in tudi pravico do nasprotovanja ponarejanju (zgoraj v točki 117 navedena sodba Centrafarm in de Peijper, EU:C:1974:115, točka 9), pa tega ni mogoče razlagati kot zagotovilo varstva tudi pred tožbami za izpodbijanje veljavnosti patenta, ker je v javnem interesu, da se odpravi vsakršna ovira za gospodarsko dejavnost, ki bi lahko izhajala iz nepravilno podeljenega patenta (zgoraj v točki 119 navedena sodba Windsurfing, EU:C:1986:75, točka 92). | 487 | Accordingly, whilst the specific subject matter of the industrial property is, in particular, the guarantee that the patentee, to reward the creative effort of the inventor, has the exclusive right to use an invention with a view to manufacturing industrial products and putting them into circulation for the first time, either directly or by the grant of licences to third parties, as well as the right to oppose infringements (judgment in Centrafarm and de Peijper, cited in paragraph 117 above, EU:C:1974:115, paragraph 9), that right cannot be interpreted as also affording protection against actions brought in order to challenge the patent’s validity, in view of the fact that it is in the public interest to eliminate any obstacle to economic activity which may arise where a patent was granted in error (judgment in Windsurfing, cited in paragraph 119 above, EU:C:1986:75, paragraph 92). |
| 488 | V zvezi s tem je treba ugotoviti, da v nasprotju z zatrjevanjem tožečih strank preudarki iz točke 92 zgoraj v točki 117 navedene sodbe Windsurfing (EU:C:1986:75) ne veljajo za določbe, ki so očitno zunaj obsega patenta. Sodišče je namreč v točki 46 navedene sodbe menilo, da tudi če bi nemški patent zajemal celotno jadralno desko, torej tudi desko, kar pomeni, da je bila zadevna določba znotraj obsega patenta, to ne pomeni, da je taka določba v skladu s členom 101 PDEU. | 488 | It must be noted, in that respect, that, contrary to the applicants’ submission, the considerations set out in paragraph 92 of the Windsurfing judgment, cited in paragraph 119 above (EU:C:1986:75), do not only apply to clauses which clearly fall outside the scope of the patent. In paragraph 46 of that judgment, the Court of Justice held that, even on the assumption that the German patent covered the complete sailboard, and therefore included the board, which would have meant that the clause in question fell within the scope of the patent, it could not be accepted that that clause was compatible with Article 101 TFEU. |
| 489 | Poleg tega Komisija v skladu s sodno prakso, čeprav ne sme opustiti vsakršno ukrepanje, kadar je obseg patenta upošteven za presojo kršitve členov 101 in 102 PDEU, ni pristojna za opredelitev obsega patenta (zgoraj v točki 119 navedena sodba Windsurfing International/Komisija, EU:C:1986:75, točka 26). | 489 | In addition, according to the case-law, although the Commission may not refrain from all action when the scope of the patent is relevant for the purposes of determining whether there has been an infringement of Articles 101 TFEU and 102 TFEU, it is not competent to determine the scope of a patent (judgment in Windsurfing International v Commission, cited in paragraph 119 above, EU:C:1986:75, paragraph 26). |
| 490 | Komisija je ob upoštevanju te sodne prakse ter ciljev, značilnih za člen 101 PDEU, ki med drugim zahtevajo, da vsak gospodarski subjekt samostojno določi politiko, ki jo namerava voditi na trgu (glej v tem smislu zgoraj v točki 341 navedeno sodbo BIDS, EU:C:2008:643, točki 33 in 34), zaradi zaščite potrošnikov pred neupravičenimi zvišanji cen zaradi dogovora med konkurenti (glej točko 386 zgoraj) utemeljeno zavrnila uporabo preizkusa obsega patenta v obravnavani zadevi za presojo spornih sporazumov z vidika člena 101(1) PDEU. | 490 | In the light of that case-law, and of the inherent objectives of Article 101 TFEU, which require, inter alia, that each economic operator must determine independently the policy which it intends to adopt on the market (see, to that effect, the BIDS judgment, cited in paragraph 341 above, EU:C:2008:643, paragraphs 33 and 34) in order to protect consumers from unjustified price increases resulting from collusion between competitors (see paragraph 386 above), the Commission was entitled to refuse to apply the ‘scope of the patent’ test in the present case in order to evaluate the agreements at issue in the light of Article 101(1) TFEU. |
| 491 | Kot je namreč Komisija navedla v točki 698 izpodbijanega sklepa, je ta preizkus z vidika prava konkurence problematičen iz več razlogov. Prvič, vodi v domnevo, da se z generičnim zdravilom krši patent proizvajalca originalnih zdravil in s tem omogoča izključitev generičnega zdravila na tej podlagi, čeprav vprašanje o ponarejenosti generičnega zdravila še ni rešeno. Drugič, temelji na domnevi, da bi bil vsak patent, na katerega bi se sklicevalo v okviru poravnave, obravnavan kot veljaven ob izpodbijanju njegove veljavnosti, čeprav za to ne bi bilo pravne ali dejanske podlage (točka 122 zgoraj). Preizkus obsega patenta torej temelji na subjektivni presoji tožečih strank o obsegu njunih patentov in njihovi veljavnosti, čeprav bi lahko imelo nacionalno sodišče ali pristojni organ drugačno stališče. | 491 | As the Commission rightly noted in recital 698 of the contested decision, that test is problematic from a competition law perspective in several respects. First, it leads to a presumption that a generic medicinal product infringes the originator undertaking’s patent and thus allows the generic medicinal product to be excluded on that basis, when the question whether it infringes any patents is an unresolved issue. Secondly, it is based on the premiss that any patent invoked in the context of a settlement agreement will be held valid if its validity is challenged, although there is no basis in law or in practice for that outcome (paragraph 122 above). The ‘scope of the patent’ test is therefore based on a subjective assessment, by the applicants, of the scope of their patents and of their validity, whereas a national court or competent authority may have taken a different view. |
| 492 | Vrhovno sodišče Združenih držav je ob koncu intenzivne razprave o tem prav tako sprejelo enak pristop pri zavrnitvi preizkusa obsega patenta, ki so ga uporabila nekatera nižja sodišča, v zgoraj v točki 353 navedeni sodbi Actavis, v kateri je menilo, da sporazum, zato ker spada v obseg patenta, ni izvzet iz tožb s področja prava konkurence. | 492 | Moreover, the Supreme Court of the United States, concluding an intense debate on that issue, adopted the same approach by rejecting the ‘scope of the patent’ test applied by some lower courts in its Actavis judgment, cited in paragraph 353 above, in which it held that the fact that an agreement fell within the scope of a patent did not exempt it from an antitrust action. |
| 493 | To, ali določena omejitev spada v obseg patenta, je namreč ugotovitev, ki izhaja iz analize obsega in veljavnosti tega patenta in ni – kot navajata tožeči stranki – izhodišče take analize (glej v tem smislu zgoraj v točki 353 navedeno sodbo Actavis). | 493 | Whether or not a restriction falls within the scope of a patent is a conclusion that follows from an examination of the scope and validity of that patent and not, as the applicants suggest, the starting point of such an examination (see paragraph 353 above as regards the Actavis judgment). |
| 494 | Ko torej tožeči stranki skušata trditi, da se s proizvodi, ki so jih generična podjetja nameravala tržiti, kršijo njuni patenti, ali da spadajo v njihov materialni, časovni ali teritorialni obseg, gre v resnici zgolj za domneve, ki temeljijo na njuni lastni subjektivni presoji, saj ne izpodbijata tega, da nobeno nacionalno sodišče niti pristojni organ ni dokazalo, da so ti proizvodi v času sklenitve spornih sporazumov kršili kateri koli od njunih patentiranih postopkov (točka 145 zgoraj). Poleg tega patent za kristalizacijo v času sklenitve večine sporazumov – kot poudarja Komisija – sploh še ni bil podeljen (točka 145 zgoraj), tako da niti obseg patentov tožečih strank niti obseg omejitev iz navedenih sporazumov, nista bila jasna. | 494 | Thus, when the applicants argue that the products that the generic undertakings intended to market infringed their patents, or fell within the material, temporal or territorial scope of those patents, those arguments are merely speculations based on their own subjective assessments, since they do not dispute that, at the time the agreements at issue were concluded, no national court or competent authority had established that those products infringed one of their process patents (paragraph 145 above). In addition, as the Commission emphasises, the crystallisation patent had not even been issued when most of the agreements at issue were concluded (paragraph 127 above), with the result that the scope of the applicants’ patents was uncertain, as was the scope of the restrictions contained in those agreements. |
| 495 | Poleg tega to, da je Komisija nekatere omejitve iz spornih sporazumov obravnavala kot take, ki so potencialno znotraj obsega patentov družbe Lundbeck, pomeni samo to, da bi lahko tožeči stranki dosegli primerljive omejitve s sodnimi odločbami pri uveljavljanju njunih patentov, če bi uspeli pred pristojnimi nacionalnimi sodišči. V tem smislu bi sporni sporazumi, tudi če bi prav tako vsebovali omejitve, potencialno znotraj obsega patentov tožečih strank, presegli posebno vsebino njunih pravic intelektualne lastnine, ki med drugim res zajemajo pravico do izpodbijanja kršitev, ne pa tudi pravice do sklenitve sporazumov, s katerimi se dejanskim ali potencialnim konkurentov plača za to, da ne vstopijo na trg (glej točko 487 zgoraj in točko 698 obrazložitve izpodbijanega sklepa). | 495 | Moreover, the fact that some restrictions contained in the agreements at issue were considered by the Commission as potentially falling within the scope of Lundbeck’s patents means only that the applicants could have obtained comparable restrictions through court rulings enforcing their patents, assuming that they succeeded in actions brought before the competent national courts. In that respect, even if the agreements at issue also contained restrictions potentially falling within the scope of the applicants’ patents, those agreements went beyond the specific subject matter of their intellectual property rights, which indeed included the right to oppose infringements, but not the right to conclude agreements by which actual or potential competitors were paid not to enter the market (see paragraph 487 above and recital 698 of the contested decision). |
| 496 | Tožeči stranki kljub temu trdita, da so med strankami spornih sporazumov v obravnavani zadevi obstajali resnični patentni spori, zato sta lahko te spore reševali s poravnavami, ne da bi kršili člen 101 PDEU. | 496 | The applicants nevertheless submit that there were real patent disputes between the parties to the agreements at issue in the present case, with the result that they could settle those disputes without infringing Article 101 TFEU. |
| 497 | Vendar je dvomljivo, ali bi sporni sporazumi dejansko omogočili rešitev osnovnih patentnih sporov med tožečima strankama in generičnimi podjetji, ker ti sporazumi ne določajo nobenega takojšnjega vstopa generikov na trg po njihovem poteku skupaj z zavezo tožečih strank, da ne bosta sprožili patentnih postopkov (glej točko 354 zgoraj in točko 662 obrazložitve izpodbijanega sklepa). | 497 | It is doubtful, however, that the agreements at issue really resolved the underlying patent disputes between the applicants and the generic undertakings, since those agreements do not provide for any immediate market entry for the generics upon the expiration of the agreement, accompanied by a commitment from the applicants to refrain from bringing patent infringement proceedings (see paragraph 354 above and recital 662 of the contested decision). |
| 498 | Sicer pa – tudi če bi sporni sporazumi omogočali rešitev spora s poravnavo med strankami – zadostuje opozorilo, da člen 101(1) PDEU ne razlikuje med sporazumi s ciljem končanja spora in tistimi z drugimi cilji (zgoraj v točki 427 navedena sodba Bayer in Maschinenfabrik Hennecke, EU:C:1988:448, točka 15). Ker pa je protikonkurenčni cilj teh sporazumov zadostno dokazan, saj gre za sporazume o odplačni izključitvi potencialnih konkurentov s trga, bi morali tožeči stranki – tudi če bi ti sporazumi lahko koristili konkurenci in potrošnikom – take ugodne učinke za konkurenco dokazati in jih analizirati z vidika člena 101(3) PDEU (glej obravnavo sedmega tožbenega razloga spodaj), ne pa da o njih presoja Komisija v okviru prvega odstavka istega člena (glej v tem smislu sodbo z dne 27. julija 2005, Brasserie nationale in drugi/Komisija, od T‑49/02 do T‑51/02, ZOdl., EU:T:2005:298, točka 85). | 498 | In addition, even if the agreements at issue had settled a dispute between the parties, it must be recalled that Article 101(1) TFEU makes no distinction between agreements whose purpose is to put an end to litigation and those concluded with other aims in mind (see, to that effect, judgment in Bayer and Maschinenfabrik Hennecke, cited in paragraph 427 above, EU:C:1988:448, paragraph 15). The anticompetitive object of those agreements being sufficiently established — since they amount to agreements excluding potential competitors from the market in exchange for payment — even if they might also have benefited competition and consumers, those effects must be demonstrated by the applicants and examined in the light of Article 101(3) TFEU (see the examination of the seventh plea in law below), and not evaluated by the Commission in the context of the first paragraph of that article (see, to that effect, judgment of 27 July 2005 in Brasserie nationale and Others v Commission, cited in paragraph 387 above, EU:T:2005:298, paragraph 85). |
| 499 | Zato tožeči stranki napačno trdita, da pravni preizkus, ki ga je uporabila Komisija, ni imel podlage v sodni praksi, ali da se prepoved iz člena 101(1) PDEU uporablja za uveljavljanje pravic intelektualne lastnine samo v izjemnih okoliščinah. Komisija ni napačno uporabila prava z zavrnitvijo preizkusa obsega patenta kot upoštevnega za analizo spornih sporazumov z vidika člena 101(1) PDEU. Kot navaja Komisija, je bil v obravnavani zadevi upošteven preizkus pojem omejitve zaradi cilja, ki je bil razvit v sodni praksi sodišč Unije (točke od 338 do 344 zgoraj). | 499 | Accordingly, the applicants are wrong in their assertion that the legal test applied by the Commission was not based on the case-law and that the exercise of intellectual property rights falls within the prohibition laid down in Article 101(1) TFEU only in exceptional circumstances. The Commission did not commit any error of law in rejecting the ‘scope of the patent’ test as the relevant test for the purpose of examining the agreements at issue in the light of Article 101(1) TFEU. As the Commission points out, the relevant test in the present case was the concept of restriction by object, as developed by the case-law of the European Union courts (paragraphs 338 to 344 above). |
| 500 | Zato se je Komisija pri ugotovitvi, da je bil cilj spornih sporazumov omejiti konkurenco v smislu člena 101(1) PDEU, v obravnavani zadevi pravilno oprla na več dejavnikov kot okvirnih elementov, kot na primer na obstoj obrnjenega plačila, pomen tega plačila in to, da je, kot kaže, ustrezalo pričakovanim donosom generičnih podjetij ob vstopu na trg, pa tudi na odsotnost določbe, ki bi olajšala vstop generikov na trg po poteku spornih sporazumov in na obstoj omejitev, ki presegajo obseg patentov tožečih strank (glej točki 661 in 662 obrazložitve izpodbijanega sklepa). | 500 | Consequently, the Commission was entitled, in the present case, to rely on a series of factors as contextual elements — such as the existence of a reverse payment, the size of that payment and the fact that it appeared to correspond to the profits expected by the generic undertakings if they had entered the market, as well as the absence of a clause enabling the generic undertakings to enter the market upon the expiry of the agreements at issue and the presence of restrictions going beyond the scope of the applicants’ patents — in order to find that those agreements had the object of restricting competition within the meaning of Article 101 TFEU (see recitals 661 and 662 of the contested decision). |
| 501 | Zato je treba prvi del zavrniti. | 501 | The first part of the fourth plea must therefore be rejected. |
| 2. Drugi del | 2. The second part |
| 502 | Tožeči stranki na prvem mestu trdita, da je zavrnitev preizkusa obsega patenta obrazložena samo v točki 698 obrazložitve izpodbijanega sklepa, v kateri je poleg tega nelogično sklepanje, ker po njunem mnenju ta preizkus ne spodbuja generičnih podjetij, da opustijo vsakršno prizadevanje za vstop na trge, ampak samo prodajo ponarejenih proizvodov. | 502 | The applicants argue, in the first place, that the reasons for rejecting the ‘scope of the patent’ test are stated only in recital 698 of the contested decision, which, moreover, is vitiated by illogical reasoning, since, in their submission, that test does not encourage generic undertakings to abandon their efforts to enter the markets, but only their efforts to sell infringing products. |
| 503 | Poleg tega pravica do izpodbijanja kršitev pomeni tudi, da lahko imetnik patenta izpodbija kršitve s sklenitvijo poravnave. Taka pravica naj bi v nasprotju z navedbami v izpodbijanem sklepu izhajala tudi iz posebne vsebine patenta. Zgoraj v točki 119 in v izpodbijanem sklepu navedeno sodbo Windsurfing (EU:C:1986:75) naj bi bilo mogoče uporabiti samo v podporo utemeljitvi, da družba Lundbeck ni pooblaščena za reševanje kolizije med proizvodi dveh tretjih proizvajalcev, kar pa se v obravnavani zadevi ni zgodilo. Sicer pa naj bi bila utemeljitev v izpodbijanem sklepu, da so poravnave dovoljene, samo če temeljijo na subjektivni oceni strank o moči patenta, v nasprotju z navedbo, da imetniki patentov ne bi smeli sami presojati o tem, ali se z generičnimi zdravili krši njihov patent. V izpodbijanem sklepu naj ne bi bilo pojasnjeno niti to, zakaj navedenega preizkusa obsega patenta, ki obstaja v pravu Združenih držav Amerike, ne bi bilo mogoče prenesti v pravo Unije. | 503 | In addition, the right to oppose infringements also implies that the patent-holder can oppose infringements by entering into a settlement agreement. Such a right also flows from the specific subject matter of a patent, contrary to what the contested decision suggests. The Windsurfing judgment, cited in paragraph 119 above (EU:C:1986:75), cited in the contested decision, can be relied on only to support the assertion that Lundbeck is not entitled to decide on a conflict between the products of two third party manufacturers, which is not the issue in this case. Furthermore, the argument raised by the contested decision, that settlement agreements are permissible only if they are based on the parties’ subjective assessment of the strength of the patent, contradicts the assertion that patent-holders should not be able to assess for themselves whether the generic medicinal products infringe their patent. Nor does the contested decision explain how the ‘scope of the patent’ test, which exists in the law of the United States of America, is not transposable to EU law. |
| 504 | Tožeči stranki na drugem mestu trdita, da to, da je Komisija zavrnila preizkus obsega patenta, ni v skladu s ključnim sklepanjem v izpodbijanem sklepu, na katerega je Komisija oprla svojo presojo spornih sporazumov. Komisija naj bi namreč sklep, da je bil cilj teh sporazumov omejevanje konkurence, oprla na trditev, da so vsebovali omejitve, ki so presegale obseg patentov družbe Lundbeck, ker se je z njimi preprečeval vstop katerega koli generičnega citaloprama na trg, ne glede na to, ali je bil ponarejen ali ne. Drugje pa naj bi Komisija navedla, da nasprotna plačila kažejo na to, da je bil cilj spornih sporazumov zavezati generična podjetja k temu, da ostanejo zunaj trga generičnega citaloprama ves čas njihovega trajanja, ne glede na to, ali so zdravila, ki bi jih ta podjetja lahko prodajala, ponarejena ali ne. | 504 | The applicants maintain, in the second place, that the Commission’s rejection of the ‘scope of the patent’ test is inconsistent with the key reasoning in the contested decision, in which the Commission focused its assessment of the agreements at issue. The Commission based its finding that the agreements had as their object the restriction of competition on the assertion that they contained restrictions going beyond the scope of Lundbeck’s patents, since they were intended to prevent the market entry of any generic citalopram, irrespective of whether it was infringing. Elsewhere, however, the Commission stated that the reverse payments as such indicated that the agreements at issue had the object of committing the generic undertakings to stay out of the generic citalopram market for the duration of the agreements, irrespective of whether or not the medicinal products which those undertakings might have been able to sell were infringing. |
| 505 | To naj bi dokazovalo, da je imel preizkus obsega patenta ključno vlogo pri analizi Komisije, kar naj bi bilo v nasprotju z njeno navedbo, da vprašanje, ali so bili sporni sporazumi znotraj obsega patentov družbe Lundbeck, ne bi bistveno spremenilo pravne analize Komisije glede teh omejitev. | 505 | That shows that the ‘scope of the patent’ test played a crucial role in the Commission’s analysis, which is at odds with its assertion that the question whether the agreements at issue remained within the scope of Lundbeck’s patents would not have fundamentally changed the Commission’s legal analysis of those restrictions. |
| 506 | Komisija te trditve zavrača. | 506 | The Commission disputes those arguments. |
| 507 | Prvič, opozoriti je treba, da mora biti obrazložitev, ki se zahteva s členom 296 PDEU, prilagojena naravi obravnavanega akta in mora jasno in nedvoumno izražati razlogovanje institucije, ki je akt izdala, tako da se lahko stranke seznanijo z utemeljitvijo sprejetega ukrepa, pristojno sodišče pa opravi nadzor (sodba z dne 29. septembra 2011, Elf Aquitaine/Komisija, C‑521/09 P, ZOdl., EU:C:2011:620, točka 147 in navedena sodna praksa). | 507 | First, it should be borne in mind that the statement of reasons required by Article 296 TFEU must be appropriate to the measure at issue and must disclose in a clear and unequivocal fashion the reasoning followed by the institution which adopted that measure in such a way as to enable the persons concerned to ascertain the reasons for it and to enable the competent court to exercise its power of review (see judgment of 29 September 2011 in Elf Aquitaine v Commission, C‑521/09 P, ECR, EU:C:2011:620, paragraph 147 and the case-law cited). |
| 508 | Tako v zvezi s posamičnimi odločbami iz ustaljene sodne prakse izhaja, da je namen obveznosti obrazložitve take odločbe poleg omogočanja sodnega nadzora zagotavljati zadevnim osebam zadostne informacije, na podlagi katerih lahko ugotovijo, ali odločba morda vsebuje napako, ki omogoča njeno izpodbijanje. Vendar je treba opozoriti, da je obveznost obrazložitve iz člena 296 PDEU bistvena postopkovna zahteva, ki jo je treba razlikovati od vprašanja utemeljenosti obrazložitve, ki je del vsebinske zakonitosti spornega akta (zgoraj v točki 509 navedena sodba Elf Aquitaine/Komisija, EU:C:2011:620, točki 146 in 148 ter navedena sodna praksa). | 508 | Thus, it is settled case-law that the purpose of the obligation to state the reasons on which an individual decision is based is, in addition to permitting review by the Courts, to provide the person concerned with sufficient information to know whether the decision may be vitiated by an error enabling its validity to be challenged. It should be borne in mind, however, that the obligation laid down in Article 296 TFEU to state adequate reasons is an essential procedural requirement that must be distinguished from the question whether the reasoning is well founded, which goes to the substantive legality of the measure at issue (judgment in Elf Aquitaine v Commission, cited in paragraph 507 above, EU:C:2011:620, paragraph 146 and 148 and the case-law cited). |
| 509 | V obravnavani zadevi je treba, kar zadeva obrazloženost izpodbijanega sklepa v zvezi z zavrnitvijo preizkusa obsega patenta, ugotoviti, da je Komisija izrecno odgovorila na trditve tožečih strank o tem vprašanju v točki 698 izpodbijanega sklepa. Komisija je v njej pojasnila razloge, iz katerih ta preizkus ne odgovarja na vprašanja, ki se porajajo v zvezi s spornimi sporazumi z vidika prava konkurence (glej točko 491 zgoraj). Poleg tega iz strukture celotnega izpodbijanega sklepa izhaja, da je Komisija uporabila pojem omejitve zaradi cilja v skladu s členom 101 PDEU z upoštevanjem gospodarskega in pravnega okvira njihove sklenitve in več dejavnikov v zvezi s tem (glej točko 354 zgoraj), s tem pa je nujno zavrnila preizkus obsega patenta kot upošteven pravni preizkus za presojo teh sporazumov z vidika člena 101(1) PDEU. | 509 | In the present case, as regards the statement of reasons, in the contested decision, for the rejection of the ‘scope of the patent’ test, it must be noted that the Commission expressly responded to the applicants’ arguments on that point in recital 698 of the contested decision. In particular, the Commission explained in that recital the reasons why that test did not respond to the concerns posed by the agreements at issue from a competition law perspective (see paragraph 491 above). In addition, it is apparent from the broad logic of the contested decision that the Commission applied the concept of restriction by object, pursuant to Article 101(1) TFEU, to the agreements at issue, taking into account the economic and legal context in which they were concluded, and taking account of a series of factors in that respect (see paragraph 354 above), thereby necessarily ruling out the ‘scope of the patent’ test as the relevant legal test in order to evaluate those agreements from the perspective of Article 101(1) TFEU. |
| 510 | Tožeči stranki zato ne moreta Komisiji očitati, da v izpodbijanem sklepu ni zadostno obrazložila zavrnitve preizkusa obsega patenta, in tudi vprašanja, ali imajo imetniki patentov pravico izpodbijati kršitve s poravnavami, kar spada v vsebinsko presojo izpodbijanega sklepa, ki je bila opravljena zgoraj v okviru drugega in tretjega tožbenega razloga. | 510 | The applicants cannot therefore claim that the Commission did not provide sufficient reasons, in the contested decision, for the rejection of the ‘scope of the patent’ test, or on whether patent holders are entitled to oppose infringements by settling their disputes, an issue concerning the substance of the contested decision, which has been examined in the context of the second and third pleas above. |
| 511 | Poleg tega tožeči stranki ne moreta uspeti s trditvijo, da bi Komisija morala svoj sklep obrazložiti s sklicevanjem na pravne preizkuse, ki se uporabljajo v Združenih državah Amerike. Razsojeno je namreč že bilo, da stališče prava tretje države ne more biti vodilo za stališče prava Unije, in da kršitev takega prava ne more biti sama po sebi taka nepravilnost, ki bi povzročila nezakonitost odločitve, sprejete na podlagi prava Unije (glej v tem smislu sodbo z dne 30. septembra 2003, Atlantic Container Line in drugi/Komisija, T‑191/98 in od T‑212/98 do T‑214/98, ZOdl., EU:T:2003:245, točki 1406 in 1407 ter navedena sodna praksa). | 511 | In addition, the applicants cannot succeed in their assertions that the Commission should have provided reasons for the contested decision by referring to the legal tests applicable in United States law. It has already been held that a legal position adopted by the law of a third country cannot take precedence over that adopted by EU law and that an infringement of that law does not constitute as such a defect resulting in the illegality of a decision adopted under EU law (see, to that effect, judgment of 30 September 2003, Atlantic Container Line and Others v Commission, T‑191/98 and T‑212/98 to T‑214/98, ECR, EU:T:2003:245, paragraphs 1406 and 1407 and the case-law cited). |
| 512 | Vsekakor zadostuje ugotovitev, da je v sodbi z večinskim stališčem Vrhovnega sodišča Združenih držav v zadevi Actavis (točka 353 zgoraj) – in ne ločenim mnenjem vrhovnega sodnika Robertsa – jasno ugotovljeno, da to, da spada v obseg patenta, določenega sporazuma ne izvzema iz tožb s področja prava konkurence, s čimer je bil zavrnjen preizkus obsega patenta kot upoštevno pravilo za presojo protikonkurenčnosti sporazumov o patentnih poravnavah z obrnjenimi plačili (tako imenovanih „pay for delay“ poravnav), kakršni so sporni sporazumi v obravnavani zadevi. | 512 | In any event, it suffices to note that the judgment containing the majority opinion of the Supreme Court of the United States in the case that gave rise to the Actavis judgment, cited in paragraph 353 above — and not the dissenting opinion of Chief Justice Roberts — clearly established that the fact that an agreement falls within the scope of a patent does not make that agreement exempt from an antitrust action, thus rejecting the ‘scope of the patent’ test as the relevant rule for the purpose of examining the anticompetitive nature of patent settlement agreements containing reverse payments (known as ‘pay for delay’ settlements) such as the agreements at issue in the present case. |
| 513 | Res je – kot sta na obravnavi navedli tožeči stranki – da je zakonodajni okvir v Združenih državah drugačen od tistega v različnih državah članicah Unije. Komisija zato pri obravnavi spornih sporazumov z vidika člena 101 PDEU upravičeno ni podrobneje obravnavala utemeljitev tožečih strank v zvezi z uporabo preizkusa obsega patenta, ki so ga uporabila nekatera nižja sodišča Združenih držav v zadevi Actavis (točka 353 zgoraj). | 513 | It is true that, as the applicants noted at the hearing, the prevailing regulatory context in the United States is different from that in the various EU Member States. The Commission was therefore right not to examine further the applicants’ arguments concerning the application of the ‘scope of the patent’ test, which had been applied by some lower courts in the United States before the Actavis judgment, cited in paragraph 353 above, in order to examine the agreements at issue in the light of Article 101 TFEU. |
| 514 | Drugič, tožeči stranki napačno trdita, da je izpodbijani sklep sam s seboj v nasprotju, ker na eni strani priznava, da so bili sporni sporazumi protikonkurenčni, ne glede na to, ali vsebujejo omejitve zunaj obsega patenta, na drugi strani pa, da ti sporazumi vsebujejo omejitve zunaj obsega njunih patentov, ker se z njimi želi preprečiti, da bi generična podjetja prodajala kateri koli generični citalopram. | 514 | Secondly, the applicants wrongly submit that the contested decision is contradictory, since it indicates, on the one hand, that the agreements at issue were anticompetitive, whether or not they contained restrictions going beyond the scope of the applicants’ patents and, on the other hand, that those agreements contained restrictions going beyond the applicants’ patents, since they were intended to prevent the sale of all types of generic citalopram by the generic undertakings. |
| 515 | Komisija je namreč v točkah 661 in 662 obrazložitve izpodbijanega sklepa pojasnila, da je bilo to, da družba Lundbeck ne bi mogla doseči enakih omejitev vstopa generikov na trg z uveljavljanjem patentiranih postopkov, med drugim pomemben indic, da so bili sporni sporazumi v nasprotju s členom 101(1) PDEU. Drugače povedano, vprašanje ali so omejitve v spornih sporazumih spadale v obseg patentov tožečih strank je bilo obravnavano kot upošteven, ne pa odločilen dejavnik pri ugotavljanju obstoja omejitve zaradi cilja v smislu navedene določbe, kar jasno izhaja tudi iz točke 641 obrazložitve izpodbijanega sklepa (točke 335, 337 in 354 zgoraj). Zato glede tega v izpodbijanem sklepu ni nobenega nasprotja. | 515 | The Commission explained, in recitals 661 and 662 of the contested decision inter alia, that the fact that Lundbeck could not have obtained the same limitations on the market entry of generics through the enforcement of its patents was an important indication, amongst others, that the agreements at issue were contrary to Article 101(1) TFEU. In other words, the issue whether the restrictions contained in the agreements at issue fell outside the scope of the applicants’ patents was considered as a relevant, but not decisive, factor in establishing the existence of a restriction of competition by object for the purpose of that provision, which is also apparent from recital 641 of the contested decision (paragraphs 335, 336 and 354 above). There is therefore no contradiction in the contested decision on that point. |
| 516 | Zato je treba četrti tožbeni razlog zavrniti. | 516 | The fourth plea must therefore be rejected. |
| F – Peti tožbeni razlog: očitna napako pri presoji dejanskega stanja, kršitev dolžne skrbnosti in neobrazloženost, ker so bili ukrepi družbe Lundbeck opredeljeni kot celovita strategija proti vstopanju generikov, upoštevna za presojo spornih sporazumov po členu 101(1) PDEU | F – The fifth plea in law, alleging a manifest error of assessment of the facts, breach of the duty of care and failure to state reasons in characterising Lundbeck’s actions as an overall strategy against the entry of generics to the market relevant for the assessment of the agreements at issue under Article 101(1) TFEU |
| 517 | Po mnenju tožečih strank izpodbijani sklep ni zadostno obrazložen, v njem so očitne napake pri presoji dejanskega stanja in kršitve dolžne skrbnosti Komisije, ker se osredotoča na nekaj izbranih navedb in zanemarja bistvena dejstva pri ugotovitvi, da sta vodili „celovito strategijo“ proti generičnim različicam citaloprama, in se na to domnevno strategijo opira pri presoji spornih sporazumov po členu 101(1) PDEU. | 517 | According to the applicants, the contested decision is insufficiently reasoned, is vitiated by manifest errors of assessment of the facts and breaches the Commission’s duty of care, in that it focused on a few selected statements and disregarded key facts when concluding that the applicants pursued an ‘overall strategy’ against generic versions of citalopram and relied on that alleged strategy when assessing the agreements at issue under Article 101(1) TFEU. |
| 518 | Tožeči stranki na prvem mestu trdita, da je bila njuna celovita strategija sestavljena iz enostranskih ukrepov, ki niso bili povezani s spornimi sporazumi, vsekakor pa niso bili nezakoniti. Menita, da je Komisija storila več resnih napak s tem, da je v izpodbijanem sklepu navedla, da sta v okviru domnevne celovite strategije proti vstopu generikov na trg citaloprama vodili več politik, in sicer, prvič, ustvaritev priložnosti za dajanje na trg escitaloprama, drugič, vložitev patentiranih postopkov za proizvodnjo citaloprama, tretjič, intervencija v postopkih izdaje DZP za generične različice citaloprama, četrtič, odprava konkurenčne grožnje prihodnjih proizvajalcev AFU citalopram, in petič, spodbujanje generičnih podjetij k opustitvi prizadevanj za vstop na trg citaloprama. | 518 | In the first place, the applicants claim that their overall strategy consisted of unilateral actions which were unrelated to the agreements at issue and in any event were not illegal. They maintain that the Commission made a number of serious errors in maintaining in the contested decision that they had pursued several policies forming part of an alleged overall strategy against generic entry to the citalopram market, namely (i) creating a window of opportunity for the launch of escitalopram; (ii) filing process patents for the manufacture of citalopram; (iii) intervening in MA procedures for the generic versions of citalopram; (iv) eliminating the competitive threat of future manufacturers of citalopram API; and (v) inciting generic undertakings to abandon their efforts to enter the citalopram market. |
| 519 | Na drugem mestu navajata, da v izpodbijanem sklepu ni pojasnjeno, zakaj je njuno ravnanje upoštevno pri ugotovitvi obstoja kršitve člena 101(1) PDEU. Po mnenju tožečih strank sicer zakoniti sporazumi ne morejo zaradi namena strank postati nezdružljivi s pravom konkurence. Subjektivni namen teh strank naj bi bil pomožen h glavnemu vprašanju, ali omejitev konkurence izhaja iz objektivnih ciljev teh sporazumov glede na okvir, v katerega spadajo. Izpodbijani sklep se napačno osredotoča na enostransko ravnanje družbe Lundbeck, ne pojasni pa, kako so se generična podjetja strinjala z domnevnim namenom družbe Lundbeck in ali so bila s tem namenom seznanjena. Zato naj Komisija na podlagi tega ravnanja ne bi mogla sklepati o ujemanju volj družbe Lundbeck in generičnih podjetij, da se omeji konkurenca generične različice citaloprama. | 519 | In the second place, the applicants submit that the contested decision does not explain how their actions are relevant to a finding of an infringement of Article 101(1) TFEU. They maintain that the parties’ intention cannot make what are otherwise lawful agreements incompatible with competition law. The parties’ subjective intention is ancillary to the main issue, namely whether a restriction of competition is apparent from the objective aims pursued by those agreements, in the light of their context. The contested decision wrongly focuses on Lundbeck’s unilateral conduct and fails to explain how the generic undertakings shared Lundbeck’s alleged intention or whether they were aware of that intention. Consequently, the Commission cannot rely on that conduct to establish the existence of a concurrence of wills between Lundbeck and the generic undertakings with the aim of containing competition from the generic version of citalopram. |
| 520 | Tožeči stranki na tretjem mestu menita, da je Komisija kršila svojo dolžno skrbnost, v skladu s katero mora skrbno in nepristransko obravnavati vse upoštevne vidike obravnavane zadeve, s tem, da ni upoštevala nobenega drugega dejstva, ki kaže na to, da so se z njunimi ukrepi uresničevali zakoniti cilji, kot je uporaba veljavnega patenta za izpodbijanje vstopa ponaredkov, dajanje na trg inovativnega proizvoda, ki je v korist potrošnikom, obveščanje zdravstvenih organov o potencialnih varnostnih tveganjih ali pridobitev dodatne proizvodne zmogljivosti. | 520 | In the third place, the applicants maintain that the Commission breached its duty of care, which requires that it examine all the relevant aspects of the case carefully and impartially, by failing to take account of all the other facts indicating that their actions were intended to implement legitimate objectives, such as enforcing a valid patent against infringing entry, launching an innovative product for the benefit of consumers, informing the health authorities of potential safety risks or obtaining additional production capacity. |
| 521 | Na četrtem mestu tožeči stranki menita, da so nekatera njuna ravnanja v izpodbijanem sklepu napačno opredeljena kot nezakonita, kot na primer premik njunih poslovnih prizadevanj k učinkovitejšemu novemu proizvodu Cipralexu, vložitev več patentnih prijav v zvezi s postopki za proizvodnjo citaloprama, njune intervencije v postopkih izdaje DZP, ali njuno poslovanje s proizvajalci AFU. Tožeči stranki tudi menita, da se v izpodbijanem sklepu napačno namiguje na to, da sta med sporom Lagap priznali, da generični proizvodi na podlagi postopka, ki ga je uporabljala družba Matrix, niso ponaredki, čeprav je bilo DZP na podlagi postopka Matrix II, ki vsebuje dodatno fazo pranja, v Združenem kraljestvu izdano šele 4. junija 2003. Družba Lundbeck naj poleg tega nikoli ne bi priznala, da je družba Matrix uporabljala postopek v industrijskem obsegu, ki je bil hkrati poslovno uspešen in ni bil ponarejen. | 521 | In the fourth place, the applicants contend that the contested decision errs in characterising some of their actions as illegal, such as the switching of their commercial efforts to a new, more effective product, Cipralex, the filing of several patent applications covering processes for the manufacture of citalopram, their interventions in MA procedures, or their dealings with API producers. The applicants also maintain that the contested decision is wrong to suggest that, in the course of the Lagap trial, they accepted that the generic products based on the process used by Matrix were not infringing, when the MA based on the Matrix II process, including a ‘washing step’, was not granted in the United Kingdom until 4 June 2003. Moreover, Lundbeck never accepted that Matrix had employed a process used on a commercial scale that was both commercially viable and non-infringing. |
| 522 | Komisija te trditve zavrača. | 522 | The Commission disputes those arguments. |
| 523 | Najprej je treba spomniti, da je Komisija povsem pravilno upoštevala namen tožečih strank v času sklenitve spornih sporazumov, ker je v sodni praksi potrjeno, da je namen strank lahko upošteven pri ugotavljanju obstoja omejitve zaradi cilja v smislu člena 101(1) PDEU (točka 344 zgoraj). | 523 | It must be recalled, first of all, that the Commission was fully entitled to take into account the applicants’ intention at the time the agreements at issue were concluded, since the case-law recognises that the parties’ intention may be a relevant factor for the purpose of establishing the existence of a restriction by object within the meaning of Article 101(1) TFEU (paragraph 344 above). |
| 524 | Dalje, v delu, v katerem tožeči stranki trdita, da njuna strategija ni bila nezakonita, ker je zajemala razvoj novega patentiranega proizvoda escitaloprama, registracijo patentiranih postopkov za citalopram ali obrambo lastnih patentov z intervencijo v postopkih izdaje DZP generičnim podjetjem, je treba ugotoviti, da v izpodbijanem sklepu ni bilo ugotovljeno, da ta ravnanja niso bila zakonita. Komisija je te dejavnike zgolj upoštevala kot upoštevna dejstva, ki omogočajo umestitev spornih sporazumov v širši okvir, s čimer je pokazala, da sta tožeči stranki želeli z vsemi možnimi sredstvi – zakonitimi in nezakonitimi – odložiti vstop generikov na trg, da bi ustvarili priložnost za dajanje escitaloprama na trg (točka 123 in naslednje obrazložitve izpodbijanega sklepa). Navedene trditve so zato v glavnem brezpredmetne. | 524 | Next, inasmuch as the applicants submit that their strategy was not unlawful, in that it consisted, inter alia, in developing a new patented product, escitalopram, in registering process patents for citalopram, or in defending those process patents by intervening in the MA procedures of generic undertakings, it must be found that the contested decision does not establish that such actions were, in themselves, unlawful. The Commission solely took into account the factors, as relevant factual evidence, that allowed the agreements at issue to be placed in their wider context and demonstrated that the applicants sought to delay the market entry of generics in order to find a suitable window for the launch of escitalopram (recitals 123 et seq. of the contested decision), by all possible means, whether lawful or unlawful. Those arguments are therefore largely ineffective. |
| 525 | Kljub temu pa je treba ugotovitve v obsegu, v katerem je mogoče trditve tožečih strank razlagati tako, da se z njimi skuša izpodbijati dejanska presoja Komisije v izpodbijanem sklepu z uveljavljanjem izkrivljanja dokazov v zvezi s tem, navesti v nadaljevanju. | 525 | Nevertheless, inasmuch as the applicants’ arguments may also be interpreted as challenging the factual assessments carried out by the Commission in the contested decision, by alleging a distortion of the evidence in that respect, the following must be noted. |
| 526 | Prvič, v zvezi z zatrjevanjem tožečih strank, da je za njune patente veljala domneva veljavnosti in da nobeno sodišče ni ugotovilo odsotnosti kršitev generičnih podjetij v času sklenitve spornih sporazumov, je treba opozoriti na to, da Komisija v izpodbijanem sklepu ni ugotovila, da patentirani postopki tožečih strank niso bili veljavni, ali da nista imeli nobene možnosti za izpodbijanje vstopa generikov na trg, če bi ti vstopili s tveganjem, ampak da je obstajala negotovost v zvezi s tem in da je bila znatno zmanjšana ali odpravljena s spornimi sporazumi (točke 336, 363 in 429 zgoraj). | 526 | First, as regards the applicants’ allegations that their process patents enjoyed a presumption of validity and that no court had found the absence of infringement by the generic undertakings at the time the agreements at issue were infringed, it must be recalled that the Commission never found, in the contested decision, that the applicants’ process patents were not valid or that they had no chance of opposing the market entry of generic undertakings if the latter had entered the market ‘at risk’, but that there was uncertainty in that respect, which was considerably reduced or eliminated by the agreements at issue (paragraphs 336, 363 and 429 above). |
| 527 | Poleg tega je Komisija notranje ocene družbe Lundbeck v zvezi z možnostmi razveljavitve patenta za kristalizacijo v izpodbijanem sklepu uporabila predvsem za dokazovanje, da so bili družba Lundbeck in generična podjetja v času sklenitve spornih sporazumov potencialni konkurenti (točka 96 zgoraj in točka 627 obrazložitve izpodbijanega sklepa). Ne glede na okvir, v katerem je bila ta izjava dana, in na identiteto njenega avtorja, iz nje dejansko izhaja – kot je Komisija ugotovila v izpodbijanem sklepu – da je obstajala negotovost glede tega, ali bi patenti družbe Lundbeck omogočali zaustavitev vsakršnega vstopa generičnih podjetij na trg, in da so imela zadnjenavedena za to v času sklenitve spornih sporazumov dejanske in konkretne možnosti. Sicer pa tožeči stranki priznavata, da so bili nacionalni razveljavitveni postopki velika neznanka. | 527 | In addition, Lundbeck’s internal estimates concerning the chances of the crystallisation patent being invalidated were used principally by the Commission in the contested decision in order to establish that Lundbeck and the generic undertakings were potential competitors at the time of concluding the agreements at issue (see paragraph 96 above and recital 627 and the contested decision). Regardless of the context in which that statement was made, or the identity of its author, it is apparent from it, as the Commission noted in the contested decision, that there was uncertainty as to whether Lundbeck’s patents would have enabled it to block the market entry of all the generic undertakings, and that those generic undertakings had real concrete possibilities to enter the market at the time the agreements at issue were concluded. The applicants also acknowledge that the invalidity proceedings at the national level were characterised by significant unknowns. |
| 528 | Drugič, tožeči stranki napačno menita, da se izpodbijani sklep ne opira na noben konkreten dokument pri dokazovanju povezave med spornimi sporazumi in dajanjem na trg escitaloprama. Izpodbijani sklep se namreč v zvezi s tem opira zlasti na izvleček strateškega načrta družbe Lundbeck za leto 1993 (točka 135 obrazložitve), dokument, pripravljen za sestanek upravnega odbora družbe Lundbeck A/S dne 24. aprila 1998 (točka 136 obrazložitve), dokument družbe Lundbeck z dne 24. septembra 1999 (točka 138 obrazložitve), poslovni in finančni načrt družbe Lundbeck za leta 1999 (točka 137 obrazložitve), 2001 (točka 139 obrazložitve) in 2002 (točka 140 obrazložitve), in na rokopis zabeležke strateškega sestanka družbe Lundbeck na začetku leta 2003 (točka 141 obrazložitve). Zadnjenavedeni dokument na primer dokazuje, da se je družba Lundbeck nameravala boriti proti generikom zaradi ustvaritve priložnosti za prehod na escitalopram. Poleg tega je družba Lundbeck v svojem poslovnem in finančnem načrtu za leto 2003 ugotovila, da je bil vstop generikov, sprva predviden za prvo četrtletje leta 2002, zelo učinkovito preložen do oktobra 2002, in da je očitno, da ima odsotnost generikov pozitiven učinek za razvoj prodaje Cipralexa (escitaloprama) leta 2003 (točka 206 obrazložitve izpodbijanega sklepa). | 528 | Secondly, the applicants wrongly submit that the contested decision does not rely on any specific document in order to establish a link between the agreements at issue and the launch of escitalopram. The contested decision is based, inter alia, in that respect, on Lundbeck’s strategic plan for 1993 (recital 135), on a document prepared for a Lundbeck A/S board meeting of 24 April 1998 (recital 136), on a Lundbeck document of 24 September 1999 (recital 138), on Lundbeck’s Budget and Activity Plan for 1999 (recital 137), 2001 (recital 139), and 2002 (recital 140), and on handwritten notes taken at a Lundbeck strategic meeting at the beginning of 2003 (recital 141). That latter document, for example, shows that Lundbeck was considering fighting the generics in order to create a window of opportunity to switch to escitalopram. In addition, in Lundbeck’s Budget and Activity Plan for 2003, Lundbeck had concluded that the market entry of generics, initially expected for the first quarter of 2002, had been very effectively postponed until October 2002, and that it was obvious that the absence of generics had had a positive effect on the development of Cipralex sales (escitalopram) in 2003 (recital 206 of the contested decision). |
| 529 | Tretjič, tožeči stranki ne moreta uspeti niti z uveljavljanjem izkrivljenja podrobnosti postopka Lagap v Združenem kraljestvu v izpodbijanem sklepu. Iz dokazov, ki jih je predložila Komisija in jih tožeči stranki niti ne izpodbijata, namreč izhaja, da sta tožeči stranki v navedenem postopku trdili, da se je s citalopramom, ki ga je proizvajala družba Matrix, kršil patent za kristalizacijo, vendar pa je šlo ponovno za njuno subjektivno presojo, ker te trditve ni nikoli potrdilo sodišče, ki je odločalo o zadevi, ker sta tožeči stranki raje sklenili poravnavo z družbo Lagap in se izognili porazu, ki bi bil po njunih lastnih besedah „ponižujoč“ in bi „bil uporabljen zoper njiju pred drugimi sodišči“ (točka 160 obrazložitve izpodbijanega sklepa). Tožeči stranki nista dokazali, zakaj naj bi se z izpodbijanim sklepom izkrivili dokazi v zvezi s tem v njem. | 529 | Thirdly, the applicants’ allegation of a distortion, in the contested decision, of the details of the Lagap trial in the United Kingdom also cannot succeed. It can be seen from the evidence put forward by the Commission, which, moreover, is not called into question by the applicants, that, although, in the context of that trial, the applicants indeed claimed that the citalopram produced by Matrix infringed the crystallisation patent, this was again their subjective assessment, since that allegation was never confirmed by the court adjudicating on the case, the applicants having preferred to reach a settlement with Lagap in order to avoid a defeat which, in their own words, would have been ‘humiliating’ and would have been ‘used against [them] in other jurisdictions’ (recital 160 of the contested decision). The applicants have not established how the Commission distorted the evidence set out in the contested decision in that respect. |
| 530 | Tožeči stranki kljub temu navajata, da je bilo DZP v zvezi z dodatno fazo pranja (torej postopkom Matrix II) v Združenem kraljestvu izdano šele 3. decembra 2003, zato je generični citalopram, ki se je v Združenem kraljestvu tržil pred tem datumom, temeljil na postopku Matrix I, glede katerega sta menili, da krši njune patente, ker temelji na ponarejenih podatkih. To pa ni bilo nikoli dokazano; nasprotno, iz točke 155 obrazložitve izpodbijanega sklepa izhaja, da je sodišče Združenega kraljestva, ki je odločalo o sporu zoper družbo Lagap, v vmesni sodbi z dne 14. februarja 2003 ugotovilo, da „je bila družba Lundbeck takrat prisiljena priznati, da njeno trdno in neomajno prepričanje, da ni mogoče, da družba Lagap in njeni dobavitelji uporabljajo neponarejen postopek, ni bilo utemeljeno“, zato tožeči stranki ne moreta uveljavljati izkrivljenja dokazov v zvezi s tem. | 530 | The applicants nevertheless maintain that the MA relating to the additional ‘washing step’ (that is to say the Matrix II process) was not granted until 3 December 2003 in the United Kingdom, with the result that the generic citalopram sold before that date in the United Kingdom was based on the Matrix I process, which, according to the applicants, infringed their patents since it was based on falsified data. However, that has never been established; rather, on the contrary, it can be seen from recital 155 of the contested decision that, in an interim ruling of 14 February 2003, the United Kingdom judge ruling on the action against Lagap stated that ‘Lundbeck now had to admit ... that their firm and unshakeable confidence that it was impossible for Lagap and its suppliers to be operating a non-infringing process was unfounded’, with the result that the applicants cannot allege distortion of the evidence in that respect. |
| 531 | Četrtič, v zvezi s trditvijo tožečih strank, da je bil namen njunega poslovanja s proizvajalci AFU izključno najti rešitev za težave z zmogljivostmi, ki so jih imeli, je treba ugotoviti, da taka razlaga ni verjetna glede na dokaze, ki jih je Komisija predložila v točki 172 in naslednjih obrazložitve izpodbijanega sklepa. Natančneje, težko je razumeti, zakaj bi bilo za družbo Lundbeck nujno ali celo koristno, da kupi italijansko podjetje VIS Farmaceutici S.p.A (v nadaljevanju: družba VIS) in da umakne DMF tega podjetja iz vloge za DZP družbe Tiefenbacher, o kateri so odločali nizozemski organi (točka 176 obrazložitve izpodbijanega sklepa), za rešitev takih težav z zmogljivostmi. | 531 | Fourthly, as regards the applicants’ allegation that the sole purpose of their dealings with the API producers was to find a solution to the capacity problems with which they were faced, it must be pointed out that this explanation is unlikely, in view of the evidence adduced by the Commission in recitals 172 et seq. of the contested decision. In particular, it is difficult to understand why it was essential or even useful for Lundbeck to take over the Italian business VIS Farmaceutici S.p.A (‘VIS’) and to withdraw its DMF from Tiefenbacher’s MA, which was pending before the Netherlands authorities (recital 176 of the contested decision), in order to resolve such capacity problems. |
| 532 | Nazadnje, tožeči stranki napačno trdita, da je bilo v izpodbijanem sklepu ugotovljeno, da nista uspeli z njunimi tožbami proti kršitvam. Nasprotno, v njem je potrjeno, da sta tožeči stranki pri nekaterih sodiščih lahko sprva dosegli začasne odredbe ali zasege v nekaterih državah, vendar so bili ti, potem ko so številna generična podjetja prešla na postopek Matrix II, bodisi odpravljeni ali zavrnjeni bodisi so bile sklenjene poravnave. V izpodbijanem sklepu je ugotovljeno samo, da nobeno sodišče v EGP v času sklenitve spornih sporazumov ni ugotovilo, da je patent za kristalizacijo veljaven in da je bil kršen (točka 185 obrazložitve izpodbijanega sklepa), česar tožeči stranki sicer ne izpodbijata (točka 145 zgoraj). | 532 | Lastly, the applicants’ submission that the contested decision found that their infringement actions had failed is incorrect. On the contrary, the contested decision acknowledges that, initially, the applicants were able to obtain injunctions in certain courts or seizure orders in certain States, but that, after numerous generic undertakings switched to the Matrix II process, those injunctions or seizure orders were either lifted or denied, or resulted in settlements. The contested decision merely concludes that at the time the agreements at issue were concluded, no court in the EEA had found that the crystallisation patent was both valid and infringed (recital 185 of the contested decision), which, moreover, the applicants do not dispute (paragraph 145 above). |
| 533 | Na podlagi navedenih preudarkov je treba peti tožbeni razlog zavrniti kot brezpredmeten ali vsekakor neutemeljen. | 533 | In view of all the foregoing, it is necessary to reject the fifth plea as ineffective or, in any event, unfounded. |
| G – Šesti tožbeni razlog: očitno napačna presoja dejanskega stanja, ker je v izpodbijanem sklepu ugotovljeno, da sporni sporazumi vsebujejo omejitve, ki presegajo tiste, značilne za izvrševanje pravic na podlagi patentov družbe Lundbeck | G – The sixth plea in law, alleging a manifest error of assessment of the facts in that the contested decision finds that the agreements at issue contained restrictions going beyond those inherent in the exercise of the rights conferred by Lundbeck’s patents |
| 534 | Tožeči stranki trdita, da je bila v izpodbijanem sklepu storjena očitna napaka pri presoji, ker v njem niso bile obravnavane vse okoliščine spornih sporazumov in ker je bilo napačno ugotovljeno, da so ti vsebovali omejitve, ki presegajo tiste, značilne za izvrševanje pravic, ki jih jima dajejo njuni patenti. Vsi sporni sporazumi naj bi bili znotraj obsega patentov družbe Lundbeck in naj bi samo preprečevali prodajo ponarejenega citaloprama. | 534 | The applicants claim that the contested decision is vitiated by a manifest error of assessment in that it fails to examine all the circumstances of the agreements at issue and incorrectly finds that those agreements contained restrictions going beyond those inherent in the exercise of the rights which their patents confer on them. They maintain that each of the agreements at issue remained within the scope of their patents and prevented only the sale of infringing citalopram. |
| 535 | Tožeči stranki na prvem mestu menita, da je v izpodbijanem sklepu napačno ugotovljeno, da so sporni sporazumi generičnim podjetjem preprečevali prodajo citaloprama, tudi neponarejenega, in so torej presegli pravice tožečih strank na podlagi njunih patentov. | 535 | In the first place, the applicants maintain that the contested decision wrongly concludes that the agreements at issue prevented the generic undertakings from selling citalopram, including non-infringing citalopram, and therefore went beyond the rights which the applicants derived from their patents. |
| 536 | Trdita, da če bi želeli generičnim podjetjem preprečiti prodajo vseh vrst citaloprama, bi morali skleniti sporazume z vsemi potencialno vstopajočimi, v tistem času pa naj bi bilo več kot 300 generičnih podjetij, ki so v EGP prodajala zdravila proti depresiji. Družba Lundbeck naj ne bi imela nobenega verjetnega razloga za preprečitev prodaje neponarejenih zdravil samo štirim generičnim podjetjem. | 536 | They claim that, if they had intended to prevent the generic undertakings from selling all citalopram, they would have had to enter into agreements with all potential entrants, when at the time there were more than 300 generic undertakings selling antidepressants in the EEA. Lundbeck had no plausible reason to prevent the sale of non-infringing medicinal products by only four generic undertakings. |
| 537 | Tožeči stranki na drugem mestu trdita, da v izpodbijanem sklepu pri ugotovitvi, da so sporni sporazumi presegli obseg njunih patentov, pri nobenem od teh sporazumov niso bile upoštevane vse okoliščine v zvezi z njimi in ni bila proučena prava volja strank, ki je lahko razvidna iz določb pogodbe in ravnanja zadevnih podjetij. | 537 | In the second place, the applicants claim that, for each of the agreements at issue, the contested decision fails to take account of all the relevant circumstances and fails to examine the faithful expression of the parties’ intention, which may result both from the clauses of a contract and from the conduct of the undertakings concerned, in finding that those agreements went beyond the scope of the applicants’ patents. |
| 538 | Komisija te trditve zavrača. | 538 | The Commission disputes those arguments. |
| 539 | Uvodoma je treba tako kot Komisija ugotoviti, da tudi če sporni sporazumi ne bi presegali obsega patentov tožečih strank, bi kljub temu pomenili omejitev konkurence zaradi cilja v smislu člena 101(1) PDEU, ker so tvorili omejevalne sporazume, s katerimi se je preložil vstop generičnih podjetij na trg v zameno za znatna obrnjena plačila (glej drugi, tretji in četrti tožbeni razlog zgoraj) in ki so negotovost v zvezi s tem vstopom spremenili v gotovost, da se ne bo zgodil med trajanjem spornih sporazumov (točka 363 zgoraj). | 539 | As a preliminary point, it must be noted that, as the Commission submits, even if the agreements at issue had not gone beyond the scope of the applicants’ patents, those agreements would nevertheless have constituted restrictions on competition by object for the purpose of Article 101(1) TFEU, since they consisted in agreements intended to delay the market entry of generic undertakings, in exchange for significant reverse payments (see the second, third and fourth pleas in law above), which transformed the uncertainty in relation to that market entry into the certainty that it would not take place during the term of the agreements at issue (paragraph 363 above). |
| 540 | Ta tožbeni razlog je zato brezpredmeten. | 540 | The present plea in law is therefore ineffective. |
| 541 | Kljub temu pa je treba podredno obravnavati trditve tožečih strank v zvezi s tem v obsegu, v katerem Komisija meni, da tožeči stranki ne izpolnjujeta pogojev, ki sta jih sami postavili, ker pogodbene omejitve iz spornih sporazumov ne veljajo samo za ponarejene proizvode in presegajo obseg zadevnih patentov. | 541 | It is appropriate, nevertheless, to examine the applicants’ arguments in that respect, as a secondary point, inasmuch as the Commission maintains that the applicants do not meet the conditions that they themselves established, since the contractual restrictions contained in the agreements at issue are not limited to potentially infringing products and exceed the scope of the patents in question. |
| 1. Sporazum GUK za Združeno kraljestvo | 1. The GUK United Kingdom agreement |
| 542 | Po mnenju tožečih strank je v izpodbijanem sklepu napačno ugotovljeno, prvič, da je obveznost podjetja Merck (GUK), da ne bo dalo na trg citaloprama, ki je temeljil samo na AFU družbe Natco, veljala ne glede na to, ali je bila AFU družbe Natco ponarejena ali ne, in drugič, da je obveznost izključnega odkupa iz tega sporazuma preprečevala podjetju Merck (GUK) prodajo katere koli druge generične različice citaloprama. | 542 | According to the applicants, the contested decision errs when it considers, first, that Merck (GUK)’s obligation not to launch citalopram based on only Natco’s API applied irrespective of whether Natco’s API was infringing and, secondly, that the exclusive purchase obligation in that agreement prevented Merck (GUK) from selling any other generic version of citalopram. |
| 543 | Komisija te trditve zavrača. | 543 | The Commission disputes those arguments. |
| 544 | Tožeči stranki na prvem mestu menita, da je v izpodbijanem sklepu napačno ugotovljeno, da je bil sporazum GUK za Združeno kraljestvo ovira za prodajo citaloprama družbe Natco ne glede na to, ali je bil ta ponarejen. Trdita, da se je sporazum GUK za Združeno kraljestvo nanašal samo na en proizvod, in sicer citalopram družbe Natco, ki ga je družba Lundbeck preizkusila in ocenila, da se z njim kršijo njeni patenti. | 544 | In the first place, the applicants argue that the contested decision was wrong to find that the GUK United Kingdom agreement prevented sales of Natco’s citalopram, irrespective of whether it was infringing. They submit that the GUK United Kingdom agreement applied to only one product, namely the Natco citalopram, which Lundbeck had tested and found to infringe its patents. |
| 545 | Izpodbijani sklep naj bi se pri ugotovitvi, da patenti družbe Lundbeck, v konkretnem primeru patent za kristalizacijo, niso bili veljavni niti kršeni, in da nobena objavljena patentna prijava ni problematična, napačno opiral na navedbe v dveh notranjih elektronskih sporočilih podjetja Merck (GUK). V izpodbijanem sklepu naj prav tako ne bi bili upoštevani drugi dokumenti podjetja Merck (GUK) iz upoštevnega obdobja dejanskega stanja, ki kažejo na to, da je bilo zadnjenavedeno zelo zaskrbljeno, da se z AFU družbe Natco kršijo patenti družbe Lundbeck, niti tega, da je podjetje Merck (GUK) med upravnim postopkom priznalo, da ni prepričano, da se s postopkom družbe Natco ne kršijo patentirani postopki družbe Lundbeck. | 545 | The contested decision incorrectly relies on statements in two Merck (GUK) internal emails for its finding that Lundbeck’s patents, in point of fact the crystallisation patent, were neither valid nor infringed, and that none of the published patent applications constituted a problem. Furthermore, the contested decision fails to have regard to other Merck (GUK) documents contemporaneous with the facts which show that Merck (GUK) had serious concerns that Natco’s API infringed Lundbeck’s patents, or to the fact that during the administrative procedure Merck (GUK) admitted that it was not confident that Natco’s process did not infringe Lundbeck’s process patents. |
| 546 | Tožeči stranki tudi menita, da sporazum GUK za Združeno kraljestvo nikakor ni mogel zajemati citaloprama, proizvedenega na podlagi različnih neponarejenih postopkov, ker naj ga družba Natco in podjetje Merck (GUK) v kratkem obdobju trajanja tega sporazuma ne bi mogla zamenjati za novo zdravilo. | 546 | In addition, the applicants contend that the GUK United Kingdom agreement could not in any event encompass citalopram produced according to different and non-infringing processes, since Natco and Merck (GUK) would have been unable to switch to a new medicinal product during the brief term of that agreement. |
| 547 | V zvezi s tem je treba spomniti, da iz točke C preambule sporazuma GUK za Združeno kraljestvo izrecno izhaja, da se podjetje Merck (GUK) ni strinjalo s tem, da je njegov proizvod ponaredek, ampak da je priznalo, da obstaja tveganje patentnega spora, kar bi lahko povzročilo zamude in nevšečnosti. | 547 | It must be borne in mind, in that respect, that it is clear from point C of the preamble to the GUK United Kingdom agreement that Merck (GUK) did not accept that its product was infringing, but that it acknowledged that there was a risk of patent litigation, which could give rise to delays and disadvantages. |
| 548 | Poleg tega je treba ugotoviti – tako kot Komisija v točki 768 obrazložitve izpodbijanega sklepa – da v sporazumu GUK za Združeno kraljestvo sploh ni bilo opredeljeno, kateri patent tožečih strank naj bi bil kršen. | 548 | In addition, it must be pointed out, as the Commission noted in recital 768 of the contested decision, that the GUK United Kingdom agreement did not even specify which of the applicants’ patents had allegedly been infringed. |
| 549 | Tožeči stranki zato napačno ponovno trdita, da so bili generični proizvodi podjetja Merck (GUK) ponarejeni, ker taka trditev temelji zgolj na njuni lastni subjektivni presoji (točka 122 zgoraj). To, da je morda podjetje Merck (GUK) dvomilo v ponarejenost svojih proizvodov, samo potrjuje negotovost, v kateri so se znašli tožeči stranki in generična podjetja v času sklenitve spornih sporazumov, ne omogoča pa ugotovitve, da je bila AFU družbe Natco ponarejena. Poleg tega objektivni dokazi, na katere se je Komisija oprla v izpodbijanem sklepu, nasprotno kažejo na to, da je bilo podjetje Merck (GUK) prepričano v svoj uspeh ob sporu z družbo Lundbeck (točka 125 zgoraj). | 549 | The applicants are therefore wrong to assert, again, that the generic products of Merck (GUK) were infringing, an assertion based only on their own subjective assessment (paragraph 221 above). The fact that Merck (GUK) may have had doubts as to whether its products were infringing merely confirms the state of uncertainty which the applicants and the generic undertakings were in at the time the agreements at issue were concluded, but in no way establishes that Natco’s API was infringing. In addition, the objective evidence on which the Commission relied in the contested decision shows rather that Merck (GUK) was confident about its chances of succeeding in the event of litigation with Lundbeck (paragraph 125 above). |
| 550 | Ker so bile druge trditve tožečih strank zavrnjene že v okviru obravnave prvega tožbenega razloga v zvezi s potencialno konkurenco, je treba napotiti na ta tožbeni razlog in na točke od 207 do 236 zgoraj v zvezi s konkretnim položajem podjetja Merck (GUK). | 550 | Since the applicants’ other arguments have already been rejected in the context of the examination of the first plea in law concerning potential competition, reference must be made to the examination of that plea and to paragraphs 207 to 236 above as regards the situation of Merck (GUK) in particular. |
| 551 | Zato je treba zavrniti trditev tožečih strank, da je Komisija napačno ugotovila, da je bila s sporazumom GUK za Združeno kraljestvo omejena prodaja citaloprama družbe Natco ne glede na to, ali je bil ponarejen. | 551 | Accordingly, the applicants’ argument that the Commission wrongly concluded that the GUK United Kingdom agreement had limited the sales of Natco citalopram, irrespective of whether it was infringing, must be rejected. |
| 552 | Na drugem mestu, tožeči stranki sklepanje v izpodbijanem sklepu, da je določba o izključnosti iz člena 3.2 sporazuma GUK za Združeno kraljestvo preprečevala podjetju Merck (GUK) vstop na trg z drugo generično različico citaloprama, bodisi v obliki končnega proizvoda bodisi v obliki AFU, ocenjujeta za napačno. Menita, da se je podjetje Merck (GUK) v členu 3.2 zavezalo samo, da bo pretisne omote z 28 tabletami Cipramila po 20 g kupovalo izključno pri družbi Lundbeck, ni pa bila družba GUK omejena pri nakupu niti končnih zdravil z vsebnostjo citaloprama, ki niso od družbe Lundbeck, niti citaloprama v kateri drugi obliki, na primer AFU citalopram tretjih oseb. | 552 | In the second place, the applicants argue that the contested decision is wrong to find that the exclusivity clause in Article 3.2 of the United Kingdom agreement prevented Merck (GUK) from entering the market with another generic version of citalopram, whether in the form of a finished product or in the form of an API. In their submission, Article 3.2 merely required Merck (GUK) to purchase blisterpacks containing 28 Cipramil 20 mg tablets exclusively from Lundbeck, and did not restrict GUK’s freedom to buy either non-Lundbeck finished medicinal products containing citalopram or citalopram in any other form, for example citalopram API, from any third party. |
| 553 | V nasprotju z navedbami Komisije v izpodbijanem sklepu je taka razlaga smiselna, ker bi podjetje Merck (GUK) brez take določbe lahko kupovalo Cipramil družbe Lundbeck pri tretjih osebah, na primer pri grosistih, s čimer bi se izničil cilj družbe Lundbeck glede povečanja skupne prodaje tega končnega zdravila v Združenem kraljestvu. | 553 | Contrary to the Commission’s assertion in the contested decision, such an interpretation is logical, since, in the absence of such a clause, Merck (GUK) would have been able to buy Lundbeck’s Cipramil from third parties, such as wholesalers, which would have defeated Lundbeck’s objective of increasing the overall sales of that medicinal product in the United Kingdom. |
| 554 | Poleg tega naj bi bilo v izpodbijanem sklepu potrjeno, da „če bi se besedilo teh določb razlagalo dobesedno, bi bilo možno, da podjetju Merck (GUK) v členu 3.2 dejansko ni bil onemogočen nakup AFU citalopram pri tretjih osebah“ (točka 781 obrazložitve). Vendar naj bi bilo v izpodbijanem sklepu napačno sklepanje, da je bil podjetju Merck (GUK) onemogočen nakup AFU citalopram pri tretjih osebah, ker ni imelo nobene spodbude za to. Podjetje Merck (GUK) naj bi namreč na eni strani lahko neomejeno prodajalo citalopram, ki ni bil od družbe Lundbeck, v obliki končnega proizvoda, razen ponarejenega citaloprama družbe Natco, na drugi strani pa družba Lundbeck – če bi podjetje Merck (GUK) z nakupom AFU citalopram pri tretjih osebah kršilo člena 1.3 svojega sporazuma z družbo Schweizerhall, po katerem se je podjetje Merck (GUK) zavezalo, da bo pokrilo svojo celotno letno potrebo po AFU citalopram pri njej (točka 783 obrazložitve) – ni poznala te določbe in torej ni mogla vedeti, da podjetje Merck (GUK) domnevno ni imelo nobene spodbude za nakup AFU pri tretjih osebah. Vsekakor pa naj odsotnost spodbude ne bi izhajala iz sporazuma GUK za Združeno kraljestvo in zato ne more biti upoštevana pri opredelitvi njegovega področja uporabe. | 554 | In addition, the contested decision acknowledges that, ‘based on a literal interpretation of the wording used in these provisions, Merck (GUK) may indeed have not been restrained in Article 3.2 from buying citalopram API from third parties’ (recital 781). However, the contested decision wrongly finds that Merck (GUK) was prevented from buying citalopram API from third parties in that it had no incentive to do so. In fact, Merck (GUK) was free to sell non-Lundbeck citalopram in finished product form, with the exception of Natco’s infringing citalopram, and, moreover, if by buying citalopram API from third parties Merck (GUK) had breached Article 1.3 of its agreement with Schweizerhall, under which Merck (GUK) undertook to cover all of its annual demand for citalopram with Schweizerhall (recital 783), Lundbeck was not aware of that provision and could not therefore be aware that Merck (GUK) had no incentive to buy API from third parties. In any event, such a lack of incentive was not a consequence of the GUK United Kingdom agreement and it cannot therefore be used to define the scope of that agreement. |
| 555 | Komisija te trditve zavrača in opozarja na to, da člen 3.2 sporazuma GUK za Združeno kraljestvo določa, da se „družba GUK zavezuje, da bo končne proizvode kupovala izključno pri [družbi Lundbeck] in jih prodajala naprej prek družbe GUK in njenih povezanih družb“. Običajni pomen te določbe naj bi bil to, da je lahko podjetje Merck (GUK) končne proizvode kupovalo samo pri družbi Lundbeck, ne pa pri drugih dobaviteljih. To razlago naj bi potrjevala točka D preambule, v kateri je navedeno, da „sta se stranki dogovorili tudi, da družba GUK pokrije svoje potrebe po končnih proizvodih tako, da jih kupuje pri [družbi Lundbeck]“. Tožeči stranki naj bi med upravni postopkom celo priznali, da se je podjetje Merck (GUK) „zavezalo, da svoje potrebe po citalopramu pokrije tako, da ga kupuje izključno pri družbi Lundbeck in prodaja naprej v Združenem kraljestvu“. Te zaveze pa naj bi jasno presegale obseg patentov družbe Lundbeck. | 555 | The Commission disputes those arguments and submits that Article 3.2 of the GUK United Kingdom agreement states that ‘GUK agrees to exclusively purchase the Finished Products from [Lundbeck] for resale by GUK and its Affiliates’. That provision means, in its ordinary sense, that Merck (GUK) could acquire finished products only from Lundbeck, to the exclusion of other suppliers. That interpretation is confirmed by recital D in the preamble, which provides that the ‘parties have further agreed that GUK shall purchase its requirements of the Finished Products from [Lundbeck]’. The applicants even acknowledged during the administrative procedure that Merck (GUK) had ‘agreed to exclusively purchase its requirements of citalopram from Lundbeck for resale in the [United Kingdom]’. Those commitments clearly go beyond the scope of Lundbeck’s patents. |
| 556 | Komisija zavrača razlago tožečih strank, da se pojem „Končni Proizvodi“ nanaša izključno na Cipramil družbe Lundbeck. Ta pojem naj bi bil namreč v členu 1.1 sporazuma opredeljen kot „proizvodi z vsebnostjo citaloprama v obliki končnega pakiranja, ki jih [družba Lundbeck] dobavi družbi GUK v skladu s tem sporazumom“. Na podlagi razlage tožečih strank naj bi bila beseda „izključno“ odveč, ker je podjetje Merck (GUK) Cipramil družbe Lundbeck očitno lahko kupovalo samo pri družbi Lundbeck. Beseda „izključno“ naj bi torej pomenila, da je moralo podjetje Merck (GUK) vse svoje potrebe po citalopramu v obliki končnega proizvoda pokriti z nakupi pri družbi Lundbeck. Poleg tega bi bilo treba to določbo razlagati v skladu z namenom tožečih strank, da preprečita samostojno nastopanje generičnih podjetij na trgu. | 556 | The Commission rejects the interpretation, proposed by the applicants, that ‘finished product’ refers only to Lundbeck’s Cipramil. In fact, the expression is defined in Article 1.1 of the agreement as ‘products containing citalopram in finished pack form to be supplied by [Lundbeck] to GUK pursuant to this Agreement’. The interpretation proposed by the applicants makes the word ‘exclusively’ redundant, since Merck (GUK) could clearly buy Lundbeck’s Cipramil only from Lundbeck. The word ‘exclusively’ therefore means that Merck (GUK) was to cover all of its requirements of finished product citalopram by buying it from Lundbeck. Furthermore, that provision should be interpreted in the light of the parties’ intention, which was to avoid an independent presence of generic undertakings on the market. |
| 557 | V zvezi z nakupom AFU citalopram pri tretjih osebah naj bi bilo v izpodbijanem sklepu potrjeno, da dobesedna razlaga člena 3.2 sporazuma GUK za Združeno kraljestvo nedvomno ni preprečevala nakupa AFU pri tretjih. Kljub temu pa je bilo v izpodbijanem sklepu ugotovljeno, da podjetje Merck (GUK) ob upoštevanju pogodbe o dobavi med podjetjem Merck (GUK) in družbo Schweizerhall iz maja 2011, katere določbe so podkrepile tiste iz sporazuma GUK za Združeno kraljestvo, ni imelo nobene spodbude več za nakup AFU citalopram pri tretjih osebah. Čeprav bi namreč podjetje Merck (GUK) kupovalo AFU, ki ni bila od družbe Natco, da bi samo proizvajalo in prodajalo končni proizvod, bi tvegalo kršitev svoje obveznosti na podlagi sporazuma GUK za Združeno kraljestvo, da „pokrije svoje potrebe“ po citalopramu v obliki končnih proizvodov izključno pri družbi Lundbeck. | 557 | As regards purchases of citalopram API from third parties, the contested decision acknowledged that a literal interpretation of Article 3.2 of the GUK United Kingdom agreement clearly did not prevent Merck (GUK) from purchasing API from third parties. However, the contested decision concluded that, given the supply contract concluded between Merck (GUK) and Schweizerhall in May 2011, the terms of which reinforced those of the GUK United Kingdom agreement, Merck (GUK) had no incentive to purchase citalopram API from third parties. Even if Merck (GUK) had purchased non-Natco API in order to produce and sell a finished product itself, it would have been at risk of breaching its obligation under the GUK United Kingdom agreement to purchase ‘its requirements’ of finished product citalopram exclusively from Lundbeck. |
| 558 | V zvezi s tem je treba tako kot tožeči stranki skleniti, da ni sprejemljiva razlaga člena 3.2 sporazuma GUK za Združeno kraljestvo, ki jo je v izpodbijanem sklepu sprejela Komisija in po kateri se je podjetje Merck (GUK) zavezalo, da bo citalopram v obliki končnih proizvodov kupovalo izključno pri družbi Lundbeck zaradi trženja v Združenem kraljestvu, ob izključitvi katerega koli drugega citaloprama. | 558 | In that respect, it must be pointed out that, as the applicants submit, the Commission’s interpretation of Article 3.2 of the GUK United Kingdom agreement in the contested decision, according to which Merck (GUK) undertook to purchase citalopram exclusively in the form of finished products from Lundbeck in order to sell them in the United Kingdom, to the exclusion of all other citalopram, cannot be accepted. |
| 559 | Iz opredelitve „Končnih Proizvodov“ v členu 1.1 sporazuma GUK za Združeno kraljestvo (točka 26 zgoraj) namreč jasno izhaja, da so to končni proizvodi družbe Lundbeck, torej Cipramil. Podjetje Merck (GUK) se je torej s to določbo zavezalo samo h kupovanju tablet Cipramila družbe Lundbeck zaradi njihove nadaljnje prodaje v Združenem kraljestvu v skladu s pogodbo o distribuciji. Beseda „izključno“ iz navedene določbe v nasprotju z zatrjevanjem Komisije ne pomeni, da se je podjetje Merck (GUK) zavezalo h kupovanju in prodaji citaloprama izključno v obliki končnih proizvodov družbe Lundbeck, ob izključitvi katerega koli drugega citaloprama, ampak zavezo k temu, da bo Cipramil zaradi nadaljnje prodaje v Združenem kraljestvu kupovalo izključno pri družbi Lundbeck, ob izključitvi drugih dobaviteljev. V nasprotju z zatrjevanjem Komisije v točki 779 obrazložitve izpodbijanega sklepa taka razlaga ni absurdna, ker je bil torej lahko namen besede„izključno“ iz člena 3.2 preprečiti, da bi se podjetje Merck (GUK) lahko oskrbelo s Cipramilom pri grosistih ali drugih dobaviteljih kot je bila družba Lundbeck, v skladu s ciljem zadnjenavedene, da poveča obseg prodaje Cipramila. | 559 | It is clear from the definition of ‘Finished Products’ in Article 1.1 of the GUK United Kingdom agreement (paragraph 26 above) that they refer to finished products from Lundbeck, namely Cipramil. By that article, Merck (GUK) therefore only undertook to purchase Cipramil tablets from Lundbeck, with a view to their resale in the United Kingdom, under a distribution agreement. The term ‘exclusively’ used in that provision does not mean, contrary to the Commission’s assertion, that Merck (GUK) undertook to purchase and sell citalopram exclusively in the form of finished products from Lundbeck, excluding any other citalopram, but rather that it undertook to purchase Cipramil, for resale in the United Kingdom, from Lundbeck only, excluding other suppliers. Contrary to the Commission’s assertion in recital 779 of the contested decision, that interpretation is not absurd, since the purpose of the term ‘exclusively’ in Article 3.2 could thus have been to preclude Merck (GUK) from acquiring Cipramil from wholesalers or suppliers other than Lundbeck, in accordance with Lundbeck’s objective of increasing the volume of sales of Cipramil. |
| 560 | Poleg tega se je Komisija v podporo svoji razlagi napačno oprla na točko D preambule sporazuma GUK za Združeno kraljestvo, katere besedilo je v bistvu enako členu 3.2 sporazuma, ker so tudi tam navedeni „Končni Proizvodi“ z veliko začetnico, ki so jasno opredeljeni v členu 1.1 navedenega sporazuma. | 560 | Furthermore, the Commission wrongly relied on point D of the preamble to the GUK United Kingdom agreement, the wording of which is essentially identical to Article 3.2 of the agreement, in order to support its interpretation, since reference is also made in that article to ‘Finished Products’ — with upper case initial letters — which are clearly defined in Article 1.1 of that agreement. |
| 561 | Sicer pa dobesedna razlaga člena 3.2 sporazuma GUK za Združeno kraljestvo – kot je Komisija sama priznala v točki 781 izpodbijanega sklepa – vodi v sklep, da ta določba podjetju Merck (GUK) ni preprečevala kupovanja citaloprama v obliki AFU pri tretjih osebah. | 561 | In addition, as the Commission itself acknowledges in recital 781 of the contested decision, a literal interpretation of Article 3.2 of the GUK United Kingdom agreement leads to the conclusion that that provision did not prevent Merck (GUK) from acquiring citalopram in the form of API from third parties. |
| 562 | Ugotoviti je namreč treba, da člen 2.2 sporazuma GUK za Združeno kraljestvo določa samo to, da se podjetje Merck (GUK) zavezuje, da bo družbi Lundbeck dobavilo vse svoje „Proizvode“, ki so bili v členu 1.1 sporazuma opredeljeni kot „proizvodi citaloprama v obliki surovine, v nepakiranem stanju ali kot končni proizvod, kot so opredeljeni v Prilogi, ter proizvodi v skladu z opisom proizvodov, ki ga družba GUK predloži ob podpisu [sporazuma] in so navedeni v Prilogi 2“. Navedena Priloga pa dejansko omenja AFU družbe Natco. To pomeni, da se je podjetje Merck (GUK) na podlagi te določbe zavezalo samo k temu, da bo dobavilo svojo obstoječo zalogo citaloprama, ki je že obstajala v času podpisa sporazuma, ne pa katero drugo vrsto generičnega citaloprama od drugih proizvajalcev, kot je družba Natco, ki bi ga podjetje Merck (GUK) lahko kupilo pozneje. Sicer pa je Komisija v točki 763 izpodbijanega sklepa priznala, da se ta obveznost nanaša samo na AFU družbe Natco. | 562 | It must be noted that Article 2.2 of the GUK United Kingdom agreement provides only that Merck (GUK) undertakes to deliver to Lundbeck all of its ‘Products’, which are defined in Article 1.1 of the agreement as ‘the citalopram products … in raw material, bulk product and finished pack form as set out in the Schedule and manufactured in accordance with the specification for Products as supplied by GUK at the date of signature [of the agreement]. Attached to Schedule 2.’ That schedule actually refers to the Natco API. That means that Merck (GUK) was solely required, under that provision, to deliver its existing citalopram stock, which already existed at the time the agreement was signed, and not any other type of generic citalopram, from producers other than Natco, that Merck (GUK) could have acquired subsequently. The Commission also acknowledges, in recital 763 of the contested decision inter alia, that that obligation concerned only the Natco API. |
| 563 | Komisija je v točki 783 izpodbijanega sklepa kljub temu menila, da če bi podjetje Merck (GUK) kupovalo citalopram v obliki AFU pri tretjih osebah, bi kršilo člen 1.3 svoje dobaviteljske pogodbe z družbo Schweizerhall, ki je določala, da podjetje Merck (GUK) pokrije 100 % svoje letne potrebe po generičnem citalopramu pri zadnjenavedeni družbi (točka 210 zgoraj). Zato je Komisija v opombi 1435 izpodbijanega sklepa menila, da tudi če bi podjetje Merck (GUK) v skladu s sporazumom GUK za Združeno kraljestvo formalno lahko vstopilo na trg z generičnim citalopramom iz drugih virov, kot je bila družba Natco, pa to ni bilo mogoče zaradi sporazuma Schweizerhall. Po mnenju Komisije pa se ta dva sporazuma medsebojno podpirata, zato ju je treba brati skupaj. | 563 | In recital 783 of the contested decision, the Commission nevertheless considered that, if Merck (GUK) had purchased citalopram in the form of API from third parties, it would have breached Article 1.3 of its supply contract with Schweizerhall, which provided that Merck (GUK) would cover 100% of its annual demand for generic citalopram with Schweizerhall (see paragraph 210 above). The Commission therefore took the view, in footnote No 1435 of the contested decision, that, even if it were formally possible for Merck (GUK) to enter the market with generic citalopram acquired from sources other than Natco under the GUK United Kingdom agreement, it could not do so because of the Schweizerhall agreement. According to the Commission, those two agreements reinforced each other and must therefore be read together. |
| 564 | Vendar je treba tako kot tožeči stranki ugotoviti, da tudi če bi vedeli za obveznost podjetja Merck (GUK) glede kupovanja generičnega citaloprama izključno pri družbi Natco na podlagi dobaviteljske pogodbe z družbo Schweizerhall, taka obveznost ne izhaja iz določb sporazuma GUK za Združeno kraljestvo, ampak iz sporazuma Schweizerhall. | 564 | It must be pointed out, however, as the applicants submit, that, even if they had been aware of Merck (GUK)’s obligation to acquire generic citalopram from Natco exclusively, pursuant to a supply contract concluded with Schweizerhall, that obligation does not arise from the provisions of the GUK United Kingdom agreement but from the Schweizerhall agreement. |
| 565 | Komisija pa se na določbe drugega sporazuma, ki ni med istimi strankami, ne more opirati pri ugotavljanju vsebine določb sporazuma GUK za Združeno kraljestvo, in še posebej na to, ali te določbe vsebujejo omejitve onkraj obsega patentov družbe Lundbeck ali ne. Taka razlaga bi namreč dopuščala sklepanje, da so vse vrste sporazumov, ki jih je sklenilo podjetje Merck (GUK) in so vsebovali omejitve v zvezi z AFU družbe Natco, ki pa sta jo stranki sporazuma GUK za Združeno kraljestvo opredelili kot potencialno ponarejeno, presegale obseg patentov družbe Lundbeck zaradi obveznosti izključne dobave iz sporazuma Schweizerhall, sklenjenega pred tem med drugimi strankami. | 565 | The Commission cannot rely on the provisions of another agreement which does not concern the same parties in order to determine the content of articles of the GUK United Kingdom agreement and, in particular, in order to establish whether or not those articles contain restrictions going beyond the scope of Lundbeck’s patents. Such an interpretation would lead to the conclusion that any type of agreement concluded by Merck (GUK) containing restrictions concerning the Natco API, which was nevertheless identified as potentially infringing by the parties to the GUK United Kingdom agreement, went beyond the scope of Lundbeck’s patents, due to the exclusive supply obligation under the Schweizerhall agreement, which was concluded previously and between different parties. |
| 566 | Zato se Komisija, tudi če bi družba Lundbeck vedela za obstoj sporazuma Schweizerhall, na to ne bi mogla opirati pri sklepanju, da se je želelo s členom 3.2 sporazuma GUK za Združeno kraljestvo preprečiti podjetju Merck (GUK) vstop na trg s katero koli vrsto citaloprama, ne glede na to, ali je od družbe Natco ali ne, in ne glede na to, ali sta stranki presodili, da je potencialno ponarejen ali ne. | 566 | Accordingly, even though Lundbeck may have been aware of the existence of the Schweizerhall agreement, the Commission cannot rely on that fact in order to conclude that Article 3.2 of the GUK United Kingdom agreement was intended, in itself, to prevent Merck (GUK) from entering the market with any type of citalopram, whether or not it came from Natco, and whether or not it was deemed to be infringing by the parties. |
| 567 | Res je, kot navaja Komisija, da je treba pri razlagi spornih sporazumov upoštevati ne samo njihovo besedilo, ampak tudi njihov okvir in cilje. Pri taki metodi razlage pa Komisija ne sme zanemariti besedila določbe sporazuma, če je to besedilo dovolj jasno. | 567 | It is true that, as the Commission submits, in interpreting the agreements at issue, it is necessary to take into account not only their wording, but also their context and objectives. That method of interpretation cannot, however, lead the Commission to ignore the wording of the provisions of an agreement, where that wording is sufficiently clear. |
| 568 | Sicer pa je treba v zvezi s tem ugotoviti, da je Komisija v točki 635 obrazložitve, opombi 1562 izpodbijanega sklepa in v odgovoru na vprašanje Splošnega sodišča navedla, da bi bil sporazum Schweizerhall lahko ob kršitvi patentov družbe Lundbeck odpovedan (glej točko 224 zgoraj). Taka razlaga sporazuma Schweizerhall pa je težko v skladu z razlago sporazuma GUK za Združeno kraljestvo, ki jo je Komisija predlagala v izpodbijanem sklepu, da so omejitve presegale obseg patentov družbe Lundbeck zaradi obveznosti podjetja Merck (GUK) na podlagi sporazuma Schweizerhall, da generični citalopram kupuje izključno pri zadnjenavedeni. To, da podjetje Merck (GUK) morda ni nameravalo kupovati citaloprama, ki ga ni proizvajala družba Natco, namreč ne pomeni, da je sporazum GUK za Združeno kraljestvo vseboval omejitev onkraj obsega patentov družbe Lundbeck. | 568 | Moreover, it must be noted, in that respect, that the Commission itself stated, in recital 635 and footnote No 1562 of the contested decision, and in reply to a question put to it by the Court, that the Schweizerhall agreement could have been terminated in the event of infringement of Lundbeck’s patents (see paragraph 224 above). It is difficult to reconcile that interpretation of the Schweizerhall agreement with the interpretation of the GUK United Kingdom agreement proposed by the Commission in the contested decision, according to which the restrictions went beyond the scope of Lundbeck’s patents due to Merck (GUK)’s obligation, under the Schweizerhall agreement, to purchase generic citalopram exclusively from Schweizerhall. The fact that Merck (GUK) may not have intended to purchase citalopram that was not produced by Natco does not mean that the GUK United Kingdom agreement contains such restrictions going beyond the scope of Lundbeck’s patents. |
| 569 | Zato je treba ugotoviti, da Komisija, ki nosi dokazno breme v zvezi s tem (točke od 105 do 112 zgoraj), v izpodbijanem sklepu ni pravno zadostno dokazala, da so omejitve iz sporazuma GUK za Združeno kraljestvo presegale obseg patentov družbe Lundbeck, torej, da družba Lundbeck takih omejitev ne bi mogla doseči pri pristojnem patentnem sodišču, če bi bilo razsojeno, da so generični proizvodi na podlagi AFU družbe Natco, ki jih je podjetje Merck (GUK) nameravalo tržiti, ponaredki, in če bi ti patenti prestali morebitne nasprotne tožbe, s katerimi bi se izpodbijala njihova veljavnost. | 569 | Accordingly, it must be found that the Commission, which bears the burden of proof in that respect (paragraphs 105 to 112 above), did not establish to the requisite legal standard, in the contested decision, that the restrictions contained in the GUK United Kingdom agreement went beyond the scope of Lundbeck’s patents, that is to say that such restrictions could not have been obtained by Lundbeck before a court with jurisdiction to rule on patent-related matters if the generic products based on the Natco API that Merck (GUK) intended to bring to the market had been held to be infringing and if those patents had survived any counter-claims challenging their validity. |
| 570 | Vendar ta ugotovitev ne more vplivati na presojo zakonitosti izpodbijanega sklepa, ker je očitek tožečih strank brezpredmeten, in sicer iz razlogov v nadaljevanju. | 570 | However, that finding is not capable of affecting the examination of the lawfulness of the contested decision, since the complaint put forward by the applicants is ineffective, for the reasons set out below. |
| 571 | Prvič, ugotoviti je treba, da tožeči stranki ne izpodbijata tega, da se je podjetje Merck (GUK) v skladu s členom 1.1 sporazuma GUK za Združeno kraljestvo zavezalo, da ne bo vstopilo na trg s svojimi generičnimi proizvodi na podlagi AFU družbe Natco, in da se je v skladu s členoma 2.2 in 2.3 navedenega sporazuma zavezalo, da jima dobavi celotno zalogo citaloprama (točki 771 in 772 obrazložitve izpodbijanega sklepa), niti tega, da sta podjetju Merck (GUK) plačali 3 milijone GBP v zameno za to zavezo (točka 26 zgoraj). Podobno tožeči stranki ne izpodbijata tega, da se je podjetje Merck (GUK) v skladu s členom 2.7 sporazuma GUK za Združeno kraljestvo zavezalo, da med trajanjem tega sporazuma ne bo izdalo ali licenciralo kopij svojih že pridobljenih DZP v Združenem kraljestvu. | 571 | First, it must be noted that the applicants do not dispute that, under Article 1.1 of the GUK United Kingdom agreement, Merck (GUK) undertook not to enter the market with its generic products based on the Natco API and that, under Articles 2.2 and 2.3 of the same agreement, Merck (GUK) undertook to deliver the entirety of its stock of citalopram to the applicants (recitals 771 and 772 of the contested decision), nor the fact that they paid GBP 3 million to Merck (GUK) in exchange for that commitment (paragraph 26 above). Similarly, the applicants do not dispute that, under Article 2.7 of the GUK United Kingdom agreement, Merck (GUK) undertook not to grant or license, during the term of that agreement, a copy of the MAs it had already obtained in the United Kingdom. |
| 572 | Kot pa je navedla Komisija, so take zaveze vsekakor protikonkurenčne že zaradi svojega cilja, ne glede na to, ali presegajo obseg patentov družbe Lundbeck ali ne, ker so bile – čeprav se z njimi ni rešil noben patentni spor med strankama sporazuma GUK za Združeno kraljestvo – dosežene v zameno za znatna obrnjena plačila, in ker je bil njihov cilj preprečiti podjetju Merck (GUK) – in kateremu koli drugemu podjetju, ki je želelo uporabljati svoje DZP – da med trajanjem sporazuma vstopi na trg s svojimi generičnimi proizvodi na podlagi AFU družbe Natco, ki so bili temelj njegove dotedanje strategije za vstop na trg. | 572 | As the Commission submits, such commitments are, in any event, anticompetitive by their very object, whether or not they went beyond the scope of Lundbeck’s patents, since, far from resolving any patent dispute between the parties to the GUK United Kingdom agreement, they were obtained in exchange for significant reverse payments and they were intended to prevent Merck (GUK) — and any undertaking that wished to use its MA — from entering the market during the term of the agreement with its generic products, based on the Natco API, on which it had hitherto based its entire strategy for entering the market. |
| 573 | Kot je Komisija izpostavila v točkah 641 in 820 izpodbijanega sklepa, je v zvezi s tem pomembno, da je bila s sporazumom GUK za Združeno kraljestvo negotovost v zvezi z morebitnim izidom tožb zaradi kršitev spremenjena v gotovost, da podjetje Merck (GUK) med trajanjem sporazuma ne bo vstopilo na trg v svojimi generičnimi proizvodi, omejitve poslovne samostojnosti podjetja Merck (GUK) pa niso izhajale izključno iz analize strank sporazuma glede patentov družbe Lundbeck, ampak iz višine obrnjenega plačila, ki je v tem primeru zasenčilo to presojo in spodbudilo generično podjetje k opustitvi njegovih prizadevanj za vstop na trg. | 573 | As the Commission emphasised in recitals 641 and 820 of the contested decision, what matters, in that respect, is that the GUK United Kingdom agreement transformed the uncertainty regarding the outcome of any infringement actions into the certainty that Merck (GUK) would not enter the market with its generic products during the term of that agreement, whereas the limitations on Merck (GUK)’s commercial autonomy did not arise exclusively from an evaluation, by the parties to the agreement, of Lundbeck’s patents, but rather from the size of the reverse payment which, in such a case, overshadowed that evaluation and induced the generic undertaking not to pursue its efforts to enter the market. |
| 574 | Drugič, zaradi popolnosti je treba ugotoviti, da je Komisija v točki 784 izpodbijanega sklepa pravilno ugotovila, da podjetje Merck (GUK) zaradi določb sporazuma GUK za Združeno kraljestvo, razumljenih v njihovem okviru, ni bilo več spodbujeno h kupovanju citaloprama v obliki AFU pri tretjih osebah ali prodaji citaloprama v obliki končnih proizvodov, ki ni bil od družbe Lundbeck, čeprav bi v skladu z navedenim sporazumom to načeloma lahko počelo. | 574 | Secondly, it should be pointed out, for the sake of completeness, that the Commission rightly found, in recital 784 of the contested decision inter alia, that, due to the provisions of the GUK United Kingdom Agreement, taken in context, Merck (GUK) no longer had any incentive to purchase citalopram in the form of API from a third party, or to sell citalopram in the form of finished products other than those of Lundbeck, even though it was in principle free to do so under that agreement. |
| 575 | Najprej je treba namreč ugotoviti, da se je podjetje Merck (GUK) v skladu s členom 3.2 sporazuma GUK za Združeno kraljestvo zavezalo, da bo med trajanjem sporazuma v Združenem kraljestvu prodajalo Cipramil družbe Lundbeck, in da je bilo v skladu s členom 6.2 navedenega sporazuma plačilo zneska 5 milijonov GBP, opredeljenega kot „čisti dobiček“, pogojeno s prodajo določenega obsega teh zdravil v Združenem kraljestvu med trajanjem sporazuma. Poleg tega je treba spomniti, da je bilo treba ta znesek plačati v več obrokih, s čimer si je družba Lundbeck zagotovila ustrezno izvajanje sporazuma. | 575 | It must be borne in mind, first of all, that Merck (GUK) undertook, under Article 3.2 of the GUK United Kingdom agreement, to sell Lundbeck’s Cipramil in the United Kingdom during the term of the agreement and that, under Article 6.2 of that agreement, the payment of GBP 5 million, described as ‘net profits’, was conditional upon the sale of a certain volume of those medicinal products in the United Kingdom during the term of that agreement. It must also be noted that the sum in question was to be paid in several tranches, which allowed Lundbeck to ensure satisfactory performance of the agreement. |
| 576 | Zato podjetje Merck (GUK), tudi če bi teoretično pri tretjih osebah lahko kupovalo generični citalopram v obliki AFU in prodajalo druge vrste končnih proizvodov, kot so tisti družbe Lundbeck, za to ne bi bilo zainteresirano, ker bi lahko brez vsakršnega tveganja pridobilo 5 milijonov GBP kot zajamčeni donos od prodaje Cipramila v skladu s členom 6.2 sporazuma GUK za Združeno kraljestvo, kakršen koli poskus vstopa na trg z drugimi generičnimi proizvodi pa bi ga lahko izpostavil tožbam zaradi kršitev in odškodninskim tožbam družbe Lundbeck. Poleg tega, kot navaja Komisija v točki 784 obrazložitve izpodbijanega sklepa, ni nobenega očitnega razloga za to, da bi tretje osebe kupovale generični citalopram v obliki AFU prek podjetja Merck (GUK) za nadaljnjo prodajo v obliki končnih proizvodov v Združenem kraljestvu, če bi ga lahko kupovale pri proizvajalcu AFU ali neposredno pri svojem prednostnem dobavitelju. | 576 | Accordingly, even though Merck (GUK) could, in theory, have purchased generic citalopram in the form of API from a third party and sold types of finished products other than those of Lundbeck, it had no incentive to do so, since it was able, without taking any risks, to obtain GBP 5 million as guaranteed profits for the sale of Cipramil under Article 6.2 of the GUK United Kingdom agreement, whereas any attempt to enter the market with other generic products could have exposed it to infringement actions and actions for damages brought by Lundbeck. Furthermore, as the Commission notes in recital 784 of the contested decision, there is no apparent reason why third parties would purchase generic citalopram in the form of API from Merck (GUK), in order to resell it in the United Kingdom in the form of finished products, if they could purchase it directly from the API producer or from its preferred supplier. |
| 577 | Zato je treba kot neupoštevno zavrniti trditev tožečih strank, da je Komisija napačno ugotovila, da se je s sporazumom GUK za Združeno kraljestvo omejevala prodaja citaloprama, ki ni bil proizveden iz AFU družbe Natco. | 577 | Accordingly, the applicants’ argument that the Commission wrongly concluded that the GUK United Kingdom agreement had limited the sales of citalopram other than that produced on the basis of the Natco IPA must be rejected as ineffective. |
| 2. Sporazum GUK za EGP | 2. The GUK EEA agreement |
| 578 | Tožeči stranki v zvezi s sporazumom GUK za EGP menita, da je v izpodbijanem sklepu napačno sklepanje, da je ta sporazum zajemal neponarejeni citalopram in da je bil njegov namen izključiti družbo Natco kot dobavitelja AFU. | 578 | As regards the GUK EEA agreement, the applicants maintain that the contested decision was wrong to find that the scope of that agreement included non-infringing citalopram and that it was intended to eliminate Natco as an API supplier. |
| 579 | Tožeči stranki na prvem mestu menita, da je bilo v izpodbijanem sklepu napačno ugotovljeno, da se je sporazum GUK za EGP uporabljal za katero koli vrsto citaloprama. V izpodbijanem sklepu naj bi bila napačno uporabljena besedilna razlaga člena 1.1 sporazuma GUK za EGP, ki določa, da bo GUK „prenehal prodajati in dobavljati farmacevtske proizvode z vsebnostjo Citaloprama“, po danskem pravu, ki se je uporabljalo za ta sporazum, pa bi morala razlaga sporazumov temeljiti na skupni volji strank. Volja strank, ki jo potrjujejo točke D, F in G preambule sporazuma, pa je bila, da se ta uporablja samo za citalopram na podlagi AFU družbe Natco. Poleg tega naj bi bilo treba ta sporazum razlagati v povezavi in v skladu s sporazumom GUK za Združeno kraljestvo, ker ta dva sporazuma po mnenju Komisije pomenita enotno in nadaljevano kršitev. | 579 | In the first place, the applicants maintain that the contested decision was wrong to find that the GUK EEA agreement applied to any type of citalopram. The contested decision wrongly makes a literal interpretation of Article 1.1 of the GUK EEA agreement, which states that GUK is to ‘cease the sale and supply of pharmaceutical products containing Citalopram’, when in Danish law, which is the law applicable to that agreement, the interpretation of agreements must be based on the common intention of the parties. In fact the parties’ intention, as confirmed by recitals D, F and G in the preamble to the agreement, was that the agreement was to apply only to citalopram based on Natco’s API. In addition, that agreement should be interpreted in conjunction with and consistently with the GUK United Kingdom agreement, since according to the Commission those two agreements constitute a single and continuous infringement. |
| 580 | Razlaga Komisije v členu 1.1 sporazuma GUK za EGP naj ne bi upoštevala niti tega, da je družba Merck dura, nemška hčerinska družba družbe Merck, od 15. aprila 2002 in med celotnim trajanjem sporazuma GUK za EGP nadaljevala s prodajo citaloprama družbe Tiefenbacher v Nemčiji, in da je družba Lundbeck tožila družbo Merck dura zaradi kršitve, ne pa izvršila navedenega sporazuma. V skladu s členom 1.1 navedenega sporazuma, ki določa prepoved prodaje in dobave proizvodov z vsebnostjo citaloprama podjetju Merck (GUK), pa je bila družba Merck dura „povezana stranka“ podjetja Merck (GUK) v smislu navedene določbe, kar pomeni, da se je besedilo „proizvodi z vsebnostjo citaloprama“ lahko nanašalo samo na citalopram družbe Natco in ne na katero koli vrsto citaloprama. | 580 | Nor does the Commission’s interpretation of Article 1.1 of the GUK EEA agreement take account of the fact that Merck dura, a German subsidiary of Merck, continued to sell Tiefenbacher’s citalopram in Germany from 15 April 2002 and throughout the period covered by the GUK EEA agreement, and that Lundbeck initiated infringement proceedings against Merck dura rather than enforcing that agreement. Under Article 1.1 of the agreement, under which Merck (GUK) is prohibited from selling or supplying products containing citalopram, Merck dura was an ‘affiliate’ of Merck (GUK) for the purposes of that provision, which means that the expression ‘products containing citalopram’ could refer only to Natco’s citalopram and not to any type of citalopram. |
| 581 | Nazadnje, tožeči stranki izpodbijata sklep Komisije v točki 845 obrazložitve izpodbijanega sklepa, da zgolj iz tega, da je imelo podjetje Merck (GUK) sklenjeno pogodbo, po kateri je moralo do leta 2008 vse svoje potrebe pokriti z nakupi pri družbi Natco, logično ne izhaja, da bi morala biti njegova obveznost opustitve prodaje citaloprama med trajanjem sporazuma GUK za EGP prav tako omejena na citalopram družbe Natco. Tako sklepanje naj bi bilo očitno v nasprotju z utemeljitvijo v izpodbijanem sklepu v zvezi s sporazumom GUK za Združeno kraljestvo, da pogodbena zaveza podjetja Merck (GUK), da vse svoje potrebe pokrije z nakupi pri družbi Natco, dokazuje, da podjetje Merck (GUK) ni bilo spodbujeno k prodaji AFU ali končnih proizvodov tretjih oseb na tej podlagi. | 581 | Lastly, the applicants take issue with the Commission’s finding at recital 845 of the contested decision that it does not follow logically that, simply because Merck (GUK) had a contract to buy all its requirements from Natco until 2008, its commitment to refrain from selling citalopram during the term of the GUK EEA agreement should also be limited to citalopram from Natco. Such a finding clearly contradicts the reasoning in the contested decision concerning the GUK United Kingdom agreement, according to which Merck (GUK)’s contractual commitment to cover all its supply requirements from Natco shows that Merck (GUK) had no incentive to sell API or finished products obtained from third parties on this basis. |
| 582 | Tožeči stranki na drugem mestu menita, da je bilo v izpodbijanem sklepu napačno ugotovljeno, da se je želelo s sporazumom s podjetjem Merck (GUK) za EGP izključiti družbo Natco kot dobavitelja AFU. | 582 | In the second place, the applicants maintain that the contested decision was wrong to find that the GUK EEA agreement was intended to eliminate Natco as a supplier of API. |
| 583 | Zanikata, da je bil člen 1.1 sporazuma GUK za EGP, po katerem si mora podjetje Merck (GUK) „po najboljših močeh prizadevati zagotoviti, da družba Natco preneha dobavljati Citalopram in zdravila v zvezi s Citalopramom na Ozemlju“, namenjen izločitvi družbe Natco kot dobavitelja AFU. Ta določba naj bi bila zgolj orodje za zagotovitev, da podjetje Merck (GUK) ne bi moglo zaobiti navedeni sporazum in prodajati ponarejeni citalopram na podlagi AFU družbe Natco, na primer prek druge družbe. Temeljil naj bi na napačnem prepričanju družbe Lundbeck vsaj do junija 2002, da je bilo podjetje Merck (GUK) izključni distributer družbe Natco. Sicer pa, če Komisija v zvezi s sporazumom GUK za Združeno kraljestvo priznava, da omejitve glede AFU družbe Natco niso bile zunaj obsega patentov družbe Lundbeck, bi moralo enako veljati tudi za pogodbene omejitve iz sporazuma GUK za EGP. | 583 | The applicants deny that Article 1.1 of the GUK EEA agreement, according to which Merck (GUK) was to ‘use all reasonable efforts to ensure that Natco cease[ed] to supply Citalopram and products containing Citalopram in the Territory’, was intended to eliminate Natco as a supplier of API. That provision was merely a tool designed to ensure that Merck (GUK) could not circumvent the agreement and sell infringing citalopram based on Natco’s API through, for example, a different company. It is based on the fact that Lundbeck believed — wrongly — at least until June 2002 that Merck (GUK) was Natco’s exclusive distributor. Furthermore, if the Commission acknowledges, as regards the GUK United Kingdom agreement, that the limitations placed on Natco’s API were not outside the scope of Lundbeck’s patents, the same conclusion must apply to the contractual limitations in the GUK EEA agreement. |
| 584 | Komisija te trditve zavrača. | 584 | The Commission disputes those arguments. |
| 585 | V zvezi s tem je treba ugotoviti, da je v besedilu prvega stavka člena 1.1 sporazuma GUK za EGP določeno, da se podjetje Merck (GUK) „zavezuje, da med trajanjem sporazuma ne bo več prodajalo in kupovalo farmacevtskih proizvodov z vsebnostjo citaloprama na ozemlju EGP (vključno z neomejenim prenehanjem prodaje in dobave družbi NM Pharma AB)“ brez dodatnih podrobnosti. | 585 | It must be pointed out, in that respect, that the wording of the first sentence of Article 1.1 of the GUK EEA agreement provides that Merck (GUK) ‘shall cease the sale and supply of pharmaceutical products containing Citalopram in the [EEA] ... (including, without limitation, ceasing to sell and supply NM Pharma AB) during the term of this Agreement’, without further details. |
| 586 | Res je, da je v točkah D in E preambule navedenega sporazuma navedeno, da je bilo podjetje Merck (GUK) distributer proizvodov z vsebnostjo citaloprama, ki jih je proizvajala ali dobavljala družba Natco, in da je podjetje Merck (GUK) prodajo in dobavo proizvodov z vsebnostjo citaloprama v Združenem kraljestvu izvajalo brez licence družbe Lundbeck. | 586 | Points D and E in the preamble to that agreement indeed refer to the fact that Merck (GUK) was the distributor of products containing citalopram manufactured or delivered by Natco, and to the fact that the sale and supply of products containing citalopram in the United Kingdom by Merck (GUK) had been carried out without a licence from Lundbeck. |
| 587 | Vendar na podlagi tega ni mogoče potrditi razlage tožečih strank, da se je člen 1.1 sporazuma GUK za Združeno kraljestvo nanašal izključno na citalopram družbe Natco. | 587 | However, that does not confirm the applicants’ interpretation that Article 1.1 of the GUK EEA agreement referred solely to the Natco citalopram. |
| 588 | Če bi namreč stranki sporazuma GUK za EGP želeli vključiti izključno citalopram družbe Natco, bi besedilo člena 1.1 zapisali tako, da bi izrecno navedli ta citalopram, tako kot v preambuli sporazuma, in ne nasploh „farmacevtske proizvode z vsebnostjo citaloprama“, kakor utemeljeno navaja Komisija. Prav tako bi lahko opredelili pojem „citalopram“ in tako pojasnili, da zajema zgolj nekatere vrste citaloprama, proizvedenega po določenih metodah, tako kot v sporazumu UK (glej točko 562 zgoraj). | 588 | If the parties to the GUK EEA agreement wished to refer only to the Natco citalopram, they would have referred expressly to that citalopram in Article 1.1, and in the preamble to that agreement, and not to ‘pharmaceutical products containing citalopram’ in general, as the Commission rightly points out. They could also have defined the term ‘citalopram’ so as to specify that that term covered only certain types of citalopram, produced using certain methods, as in the United Kingdom agreement (see paragraph 562 above). |
| 589 | Poleg tega razlaga, ki jo predlagata tožeči stranki, ni verjetna glede na besedilo člena 1.3 sporazuma GUK za EGP, po katerem se družba Lundbeck zavezuje, da ne bo vložila nobene tožbe zoper podjetje Merck (GUK), če bo to spoštovalo člen 1.1 sporazuma. Strinjanje z razlago tožečih strank bi namreč pomenilo, da se je družba Lundbeck zavezala, da ne bo vložila nobene tožbe zaradi kršitev zoper podjetje Merck (GUK), če se bo zadnjenavedeno vzdržalo prodaje ali dobave citaloprama družbe Natco v EGP, tudi če bi prodajalo drugačno različico citaloprama drugega proizvajalca. To je težko združljivo z okoliščinami sklenitve spornih sporazumov, iz katerih med drugim izhaja, da je bila družba Lundbeck trdno odločena, da prepreči vsakršen vstop generikov na trg. | 589 | In addition, the interpretation proposed by the applicants is implausible, when it is compared with the wording of Article 1.3 of the GUK EEA agreement, pursuant to which Lundbeck undertakes not to initiate legal proceedings against Merck (GUK), provided that the latter observes Article 1.1 of the agreement. If the applicants’ interpretation were accepted, that would mean that Lundbeck undertook not to bring any infringement action against Merck (GUK), provided that the latter refrained from selling or supplying Natco citalopram within the EEA, even if it sold another version of citalopram from another producer. That is hard to reconcile with the context in which the agreements at issue were concluded, which demonstrates, inter alia, that Lundbeck had the firm intention to prevent any entry of generics to the market. |
| 590 | Tožeči stranki pa kljub temu trdita, da je družba Merck dura, hčerinska družba podjetja Merck (GUK), lahko vstopila na trg v Nemčiji, čeprav je bila povezana oseba v smislu člena 1.1 sporazuma GUK za EGP, kar naj bi pomenilo, da besedilo „proizvodi z vsebnostjo citaloprama“ iz navedenega člena lahko pomeni samo citalopram družbe Natco in ne kateri koli citalopram. | 590 | The applicants nevertheless submit that Merck dura, a German subsidiary of Merck (GUK), was able to enter the citalopram market in Germany, even though it was an affiliate within the meaning of Article 1.1 of the GUK EEA agreement, which implies that the expression ‘products containing citalopram’ in that article could refer only to Natco citalopram, and not to any type of citalopram. |
| 591 | Vendar je treba tako kot Komisija ugotoviti, da se je člen 1.1 sporazuma za EGP, enako kot ves preostali sporazum, uporabljal izključno za podjetje Merck (GUK) glede na relativno učinkovanje pogodbe, tako da obveznost podjetja Merck (GUK), da ne bo prodajalo generičnega citaloprama svojim povezanim družbam, ne pomeni, da te povezane družbe, kakršna je bila družba Merck dura, ne morejo kupovati od drugega vira in same prodajati generični citalopram, kakor je v obravnavani zadevi počela družba Merck dura s tem, da je kupovala pri družbi Tiefenbacher. Zato na podlagi tega, da je družba Merck dura med trajanjem sporazuma za EGP vstopila na nemški trg, niti tega, da sta tožeči stranki vložili tožbe zaradi kršitev zoper njo, ni mogoče sklepati, da se besedilo „proizvodi z vsebnostjo citaloprama“ iz člena 1.1 navedenega sporazuma ne nanaša na vse vrste citaloprama, ampak samo na citalopram družbe Natco. | 591 | It must be noted, however, as the Commission submits, that Article 1.1 of the GUK EEA agreement applies only to Merck (GUK), as does the rest of the agreement, by virtue of the principle of privity of contract, with the result that the obligation for Merck (GUK) not to sell generic citalopram to its affiliates does not mean that those affiliated companies, such as Merck dura, could not procure generic citalopram from another source and sell it themselves, as Merck dura did in the present case by purchasing generic citalopram from Tiefenbacher. It therefore cannot be inferred from the fact that Merck dura entered the German market during the term of the GUK EEA agreement, nor from the fact that the applicants brought infringement actions against it, that the terms ‘products containing Citalopram’ in Article 1.1 of that agreement did not refer to any type of citalopram but only to Natco citalopram. |
| 592 | Zato je člen 1.1 sporazuma GUK za EGP s tem, da je določal obveznost podjetja Merck (GUK), da med celotnim trajanjem tega sporazuma ne bo prodajalo ali dobavljalo proizvodov z vsebnostjo citaloprama svojim povezanim družbam ali kateri koli tretji osebi (vključno z družbo NM Pharma, ki je začela prodajati citalopram na Švedskem), vseboval omejitve onkraj obsega patentov družbe Lundbeck, ker taka obveznost ni bila omejena na citalopram, ki sta ga stranki sporazuma ocenili za potencialno ponarejen. | 592 | Accordingly, by imposing an obligation on Merck (GUK) to refrain from selling or supplying products containing citalopram to those affiliates or to any other third party (including NM Pharma which had begun to sell citalopram in Sweden) during the term of the GUK EEA agreement, Article 1.1 of that agreement contained restrictions going beyond the scope of Lundbeck’s patents, since that obligation was not limited to the citalopram deemed potentially infringing by the parties to that agreement. |
| 593 | Spomniti je treba tudi na to, da člen 1.1 sporazuma GUK za EGP ni določal samo obveznosti podjetja Merck (GUK), da med trajanjem sporazuma ne prodaja ali dobavlja proizvodov z vsebnostjo citaloprama, ampak tudi to, da si bo po najboljših močeh prizadevalo zagotoviti, da družba Natco med trajanjem sporazuma na ozemlju EGP preneha dobavljati citalopram in proizvode z vsebnostjo citaloprama. | 593 | Furthermore, it must be recalled that Article 1.1 of the GUK United Kingdom agreement not only imposed an obligation on Merck (GUK) to refrain from selling or supplying products containing citalopram for the term of the agreement, but also to use all reasonable efforts to ensure that Natco ceased to supply citalopram and products containing citalopram in the EEA during the term of the agreement. |
| 594 | Nič pa ne kaže na to, da je bila ta obveznost zgolj nepomembna ali celo neobstoječa zaveza, ali da je temeljila na napačnem prepričanju tožečih strank, da je bilo podjetje Merck (GUK) izključni distributer družbe Natco. Kot namreč navaja Komisija sta stranki sporazuma to določbo ocenili kot dovolj pomembno za pogojevanje plačila 12 milijonov EUR z njo. Sicer pa je bilo v členu 1.2 sporazuma GUK za EGP izrecno določeno, da družba Lundbeck ni bila zavezana izplačati še nezapadlih plačil, če bi družba Natco med trajanjem sporazuma dobavila citalopram ali proizvode z vsebnostjo citaloprama na ozemlju EGP. | 594 | Nothing indicates that that obligation was merely an insignificant, or even non-existent, commitment or that it was based on the applicants’ erroneous belief that Merck (GUK) was Natco’s exclusive distributor. As the Commission submits, that clause was deemed sufficiently important by the parties to the agreement to be a condition for the payment of EUR 12 million. Moreover, Article 1.2 of the GUK EEA agreement expressly provides that Lundbeck is not to be required to make any payment not yet due in the event that Natco supplies Citalopram or products containing citalopram in the EEA during the term of the agreement. |
| 595 | Čeprav podjetje Merck (GUK) družbi Natco ni moglo preprečiti dobave citaloprama na ozemlju EGP, kot navajata tožeči stranki, pa je člen 1.1 sporazuma GUK za EGP podjetje Merck (GUK) močno spodbujal k temu, da ukrene vse potrebno in si „po najboljših močeh“ prizadeva za to, če ne želi ostati brez znatnega dela plačil, ki jih je obljubila družba Lundbeck po tem sporazumu. | 595 | Accordingly, even if Merck (GUK) did not have the power to prevent Natco from supplying citalopram in the EEA, as the applicants maintain, it is nevertheless the case that Article 1.1 of the GUK EEA agreement provided a strong incentive for Merck (GUK) to take all the necessary steps and use ‘all reasonable efforts’ in that respect, or risk losing a substantial part of the payments promised by Lundbeck under that agreement. |
| 596 | To dokazuje – kot je Komisija pravilno ugotovila v točki 848 obrazložitve izpodbijanega sklepa – da objektivni cilj sporazuma GUK za EGP ni bil samo izločiti podjetje Merck (GUK) s trgov EGP kot prodajalca generičnih proizvodov na podlagi citaloprama družbe Natco, ampak tudi izločitev družbe Natco kot proizvajalke generičnega citaloprama na tem ozemlju. | 596 | That shows, as the Commission rightly found in recital 848 of the contested decision, that the objective goal of the GUK EEA agreement was not only to eliminate Merck (GUK) from the EEA markets, as a seller of generic products based on the Natco citalopram, but also to eliminate Natco as a producer of generic citalopram in that territory. |
| 597 | Zato je treba razsoditi, da je mogoče na podlagi vsebine sporazuma GUK za EGP, razlaganega v njegovem okviru, zadostno sklepati, da je podjetje Merck (GUK) v skladu z določbami tega sporazuma opustilo vsakršno možnost prodaje svoje generične različice citaloprama, ne glede na to, ali je bil od družbe Natco ali ne, in ne glede na to, ali je potencialno kršilo patent družbe Lundbeck ali ne. | 597 | It must be held, therefore, that it is sufficiently clear from the content of the GUK EEA agreement, read in context, that Merck (GUK) had, under the clauses of that agreement, abandoned all possibility of selling its generic version of citalopram, whether or not it came from Natco, and whether or not it potentially infringed Lundbeck’s patent. |
| 598 | Zato Komisija ni storila napake z mnenjem v točki 846 obrazložitve izpodbijanega sklepa, da je treba sporazum GUK za EGP in še posebej člen 1.1 tega sporazuma razlagati tako, da je podjetje Merck (GUK) zavezoval, da med trajanjem sporazuma preneha prodajati in dobavljati vse vrste citaloprama na celotnem ozemlju EGP, kar je bilo zunaj obsega patentov družbe Lundbeck. | 598 | Accordingly, the Commission did not err in finding, in recital 846 of the contested decision, that the GUK EEA agreement and, in particular, Article 1.1 of that agreement, had to be interpreted as obliging Merck (GUK) to cease selling and supplying all types of citalopram in the EEA during the term of the agreement, which went beyond the scope of Lundbeck’s patents. |
| 599 | Vsekakor pa so omejitve, ne glede na razlago tega sporazuma in ne glede na to, ali te omejitve za podjetje Merck (GUK) spadajo v obseg patentov družbe Lundbeck ali ne, kljub temu protikonkurenčne, ker ni bilo dokazano, da se s citalopramom, ki ga proizvaja družba Natco, krši kateri od teh patentov, ker je podjetje Merck (GUK) izrecno zanikalo, da so njegovi generični proizvodi ponarejeni (glej točko C preambule sporazuma UK in točko G preambule sporazuma GUK za EGP), in ker so bile omejitve njegove poslovne samostojnosti spodbujene z znatnimi obrnjenimi plačili, ki so bila povračilo za te omejitve (glej točki 572 in 573 zgoraj). | 599 | In any event, whatever the interpretation given to that agreement, and whether or not the restrictions imposed on Merck (GUK) fall within the scope of Lundbeck’s patents, those restrictions were nevertheless anticompetitive by object, since it was not established that the citalopram produced by Natco infringed one of those patents, Merck (GUK) had expressly disputed that its generic products were infringing (see point C of the preamble to the UK agreement and point G of the preamble to the GUK EEA agreement) and the restrictions on its commercial autonomy were induced by significant reverse payments, which constituted the consideration for those restrictions (see paragraphs 572 and 573 above). |
| 600 | Poleg tega sporni sporazumi, kot je Komisija ugotovila v točki 847 obrazložitve izpodbijanega sklepa, niso vsebovali nobenega povračila za zadevne omejitve – kot je na primer možnost, da bi podjetje Merck (GUK) po poteku sporazumov takoj vstopilo na trg, ne da bi se mu bilo treba bati tožb družbe Lundbeck zaradi kršitev – razen obrnjenih plačil, ki jih je obljubila zadnjenavedena, zato se niso nanašali na rešitev patentnega spora. | 600 | In addition, as the Commission found in recital 847 of the contested decision, the agreements at issue did not provide any consideration for the restrictions in question — such as the possibility for Merck (GUK) to enter the market immediately upon the expiry of the agreements without having to fear infringement actions from Lundbeck — other than the reverse payments promised by Lundbeck, with the result that those agreements were not intended to resolve any patent dispute. |
| 601 | Zato je treba očitek tožečih strank, da sporazum GUK za EGP ni vseboval nobene omejitve zunaj obsega patentov družbe Lundbeck, zavrniti kot brezpredmeten, vsekakor pa kot neutemeljen. | 601 | Accordingly, the applicants’ submission that the GUK EEA agreement did not contain any restriction going beyond the scope of Lundbeck’s patents must be rejected as ineffective and, in any event, unfounded. |
| 3. Sporazum Arrow UK | 3. The Arrow UK agreement |
| 602 | Tožeči stranki trdita, da je Komisija storila očitno napako pri presoji s tem, da je sporazum Arrow UK razlagala tako, da podjetju Arrow preprečuje prodajo katerega koli generičnega citaloprama med trajanjem tega sporazuma, ki naj bi se nanašal samo na citalopram, s katerim so bili kršeni njuni patenti. To naj bi dokazovalo besedilo tega sporazuma in okoliščine njegove sklenitve, med drugim še posebej obstoj patentnega spora s podjetjem Arrow in spor Lagap. | 602 | The applicants maintain that the Commission made a manifest error of assessment in interpreting the Arrow UK agreement as preventing Arrow from selling any form of generic citalopram during the term of that agreement, which applied only to citalopram infringing the applicants’ patents. That is shown by the wording of that agreement and by the circumstances surrounding its conclusion, including, in particular, a patent dispute with Arrow and the Lagap litigation. |
| 603 | Komisija te trditve zavrača. | 603 | The Commission disputes those arguments. |
| 604 | Tožeči stranki na prvem mestu zanikata, da se besedilo „navedeni citalopram“, opredeljen v četrti uvodni izjavi preambule sporazuma Arrow UK in uporabljen v členu 1.1 sporazuma Arrow UK (glej točko 35, druga in tretja alineja, zgoraj), nanaša na kateri koli citalopram, ki bi ga podjetje Arrow lahko kupovalo pri družbi Tiefenbacher. Menita, da se to besedilo nanaša samo na citalopram, ki ga je podjetje Arrow že kupilo ali naročilo pri zadnjenavedeni družbi in s katerim so bili kršeni njuni patenti. | 604 | In the first place, the applicants deny that the expression ‘the said Citalopram’, defined in the fourth recital in the Arrow UK preamble and used in Article 1.1 of the Arrow UK agreement (see the second and sixth indents of paragraph 35 above), refers to any type of citalopram that Arrow could buy from Tiefenbacher. According to the applicants, that expression refers only to citalopram which Arrow had already bought or ordered from Tiefenbacher and which infringed their patents. |
| 605 | Razlaga navedenega besedila, ki jo predlagata tožeči stranki, naj bi bila na eni strani potrjena z dejstvom, navedenim v šesti uvodni izjavi preambule sporazuma Arrow UK (glej točko 35, tretja alineja, zgoraj), da je bil „navedeni Citalopram“ laboratorijsko preizkušen, na drugi strani pa naj ne bi bila ovržena s tem, da se člen 1.1 sporazuma Arrow UK sklicuje na prepoved uvoza med drugim „navedenega citaloprama“ po drugem datumu dobave, opredeljenem v členu 3.4 sporazuma Arrow UK (glej točko 35, zadnja alineja, zgoraj, v nadaljevanju: drugi datum dobave). To sklicevanje naj bi namreč veljalo zgolj za besedilo „katerega koli drugega citaloprama“ iz člena 1.1 sporazuma Arrow UK. Vsekakor pa naj bi podjetje Arrow celo po drugem datumu dobave razpolagalo s tabletami citaloprama, ki jih je naročila družba Tiefenbacher in niso bile dobavljene tožečima strankama. | 605 | According to the applicants, their proposed interpretation of that expression is confirmed by the fact, set out in the sixth recital in the Arrow UK preamble (see the third indent of paragraph 35 above) that laboratory tests had been performed on ‘the said Citalopram’, and their interpretation is not called into question by the reference, in Article 1.1 of the Arrow UK agreement, to a prohibition on importing, in particular, ‘the said Citalopram’ after the second date of delivery defined in Article 3.4 of the Arrow UK agreement (see the last indent of paragraph 35 above) (‘the second delivery date’). That reference applies only to the expression ‘other Citalopram’, employed in Article 1.1 of the Arrow UK agreement. In any event, even after the second delivery date, Arrow was in possession of citalopram tablets ordered from Tiefenbacher which had not been delivered to the applicants. |
| 606 | Spomniti je treba, da se člen 1.1 sporazuma Arrow UK glasi: | „Družba Arrow [UK] se v svojem imenu in v imenu vseh povezanih oseb zavezuje, da med [trajanjem sporazuma UK] na ozemlju Združenega kraljestva ne bo proizvajala, prodajala, predlagala prodaje, uporabljala ali – po drugem datumu dobave – uvažala ali hranila za prodajo ali drug namen (1) [‚]navedenega Citaloprama[‘] ali (2) katerega koli drugega citaloprama, s katerim se po mnenju družbe Lundbeck kršijo njene pravice [intelektualne] lastnine, in da bo, da se družbi Lundbeck omogoči ugotovitev obstoja kršitve, tej med [trajanjem sporazuma UK] dobavila dovolj vzorcev za analizo vsaj en mesec pred vsakršno zagroženo proizvodnjo, uvozom, prodajo ali ponudbo prodaje do izdaje končne neizpodbojne odločbe v [okviru postopka zaradi kršitev v UK] […].“ | 606 | It must be noted that Article 1.1 of the Arrow UK agreement provides as follows: | ‘Arrow [UK] on its own behalf and on behalf of all associated and related entities undertakes during the [term of the UK agreement] not in the United Kingdom to make, dispose of, offer to dispose of, use or, after the Second Delivery date, import or keep for disposal or otherwise (1) the said Citalopram or (2) any other Citalopram which Lundbeck alleges to infringe its [intellectual property] Rights and, to enable Lundbeck to ascertain if there may be an infringement, during the [term of the Arrow UK agreement] to provide Lundbeck with sufficient samples for analysis purposes at least one month prior to any threatened manufacture, importation, sale or offer for sale pending a final unappealable decision in [the infringement action against Arrow]’. |
| 607 | Pri razlagi pomena besedila „navedeni citalopram“ iz člena 1.1 sporazuma Arrow UK je treba opozoriti, da: | — | je to besedilo opredeljen izraz iz četrte uvodne izjave preambule sporazuma Arrow UK, ki se glasi: „Družba Arrow [UK] je pridobila licenco tretje osebe, da v Združeno kraljestvo uvaža citalopram, ki ga ne proizvaja družba Lundbeck niti se ne proizvaja po njenem pooblastilu (‚navedeni Citalopram,‘ katerega opredelitev zaradi izogibanja dvomu zajema samo Citalopram, namenjen trženju in prodaji v Združenem kraljestvu, ne pa tudi tisti, namenjen trženju in prodaji v drugih državah);“ | — | iz člena 3.4 sporazuma Arrow UK izhaja, da je „drugi datum dobave“ iz člena 1.1 sporazuma Arrow UK datum, ko je morala družba Arrow UK dobaviti družbi Lundbeck drugi del svoje zaloge „navedenega Citaloprama“, in da je bilo treba to dobavo opraviti najpozneje do 15. februarja 2002. | 607 | In order to interpret the meaning of the expression ‘the said Citalopram’ contained in Article 1.1 of the Arrow UK agreement, it must be noted that: | — | that expression is a defined term used in the fourth recital of the Arrow UK preamble, which is worded as follows: ‘Arrow [UK] has obtained a licence from a third party to import into the [United Kingdom] Citalopram not manufactured by Lundbeck or with the consent of Lundbeck (“the said Citalopram”, which definition shall for the avoidance of doubt comprise only Citalopram for marketing and sale in the [United Kingdom] and shall exclude Citalopram for marketing and sale in other countries)’; | — | it is clear from Article 3.4 of the Arrow UK agreement that the ‘Second Delivery date’ referred to in Article 1.1 of the Arrow UK agreement is the date on which Arrow was to deliver to Lundbeck the second stage of its stock ‘of the said Citalopram’ and that that delivery was to take place no later than 15 February 2002. |
| 608 | Komisija je v točkah 905, od 910 do 913 in 916 obrazložitve izpodbijanega sklepa menila, da je treba besedno zvezo „navedeni citalopram“ razlagati tako, da se ne nanaša samo na citalopram, ki ga je podjetje Arrow že kupilo pri družbi Tiefenbacher, ampak tudi na ves citalopram, ki bi ga lahko kupilo pri isti družbi v prihodnje, tudi če je bila uporabljena AFU od tedaj naprej proizvedena po postopkih Cipla II ali Matrix II. Pri tem se je Komisija oprla na to, da člen 1.1 sporazuma Arrow UK omenja obdobje po „drugem datumu dobave“, kot izhaja iz člena 3.4 sporazuma Arrow UK, kar po njenem mnenju onemogoča omejitev besedne zveze „navedeni Citalopram“ na tisti, ki ga je podjetje Arrow že imelo na zalogi, in na besedilo četrte uvodne izjave preambule UK, iz katerega naj bi sledilo, da je „navedeni Citalopram“ ves citalopram, ki ga proizvaja družba Tiefenbacher in ga zajema njeno DZP. | 608 | In recitals 905, 910 to 913 and 916 of the contested decision, the Commission considered that the expression ‘the said Citalopram’ should be interpreted as covering not only the citalopram that Arrow had already purchased from Tiefenbacher but also any citalopram that it could buy from that undertaking subsequently, even if the API used was henceforth produced in accordance with the Cipla II or Matrix II processes. To that end, the Commission relied on the reference, in Article 1.1 of the Arrow UK agreement, to the period after the ‘Second Delivery date’, set out in Article 3.4 of the Arrow UK agreement, which, according to the Commission, prevents restriction of the concept of ‘the said Citalopram’ to the stock already held by Arrow and on the wording of the fourth recital in the Arrow UK preamble, from which it is apparent that ‘the said Citalopram’ is any citalopram produced by Tiefenbacher and covered by its MA. |
| 609 | Na podlagi navedenih elementov je treba ugotoviti, da se z eno od obveznosti iz člena 1.1 sporazuma Arrow UK tožečima strankama prepoveduje uvoz ali hramba „navedenega Citaloprama“ po drugem datumu dobave iz člena 3.4 tega sporazuma. Ta obveznost pa je smiselna in lahko polno učinkuje, samo če se ta besedna zveza uporablja tudi za citalopram, ki dejansko izvira od družbe Tiefenbacher, sta ga pa tožeči stranki naročili po tej dobavi. Glede tega je treba ugotoviti, da nič v tej določbi ne omogoča sklepanja, da se zgoraj navedena obveznost ne nanaša na „navedeni Citalopram“, ampak samo na „kateri koli drug citalopram, s katerim se po mnenju družbe Lundbeck kršijo njene pravice [intelektualne] lastnine“. | 609 | In the light of the abovementioned factors, it must be observed that one of the obligations provided for in Article 1.1 of the Arrow UK agreement consists of prohibiting Arrow from importing or keeping ‘the said Citalopram’ after the second delivery date referred to in Article 3.4 of that agreement. That obligation only has meaning and effectiveness if that expression also relates to citalopram indeed originating from Tiefenbacher, but ordered by Arrow after that delivery. As regards that point, it must be noted that nothing in the wording of that clause allows the view that the abovementioned obligation does not concern ‘the said Citalopram’ but only relates to ‘any other Citalopram which Lundbeck alleges to infringe its [intellectual property] Rights’. |
| 610 | Podobno je opredelitev „navedeni Citalopram“ v četrti uvodni izjavi preambule sporazuma Arrow UK zapisana z besedami, ki jih ni mogoče razlagati tako, da se nanašajo samo na citalopram, ki ga je podjetje Arrow že kupilo pri družbi Tiefenbacher. Ta uvodna izjava namreč pomeni, da je v opredelitev „navedeni Citalopram“ vključen ves citalopram, ki je zajet z DZP družbe Tiefenbacher. To DZP pa je veljalo za citalopram, proizveden po postopkih Cipla I in Matrix I, ne glede na to, da so bile tablete na zalogi pri podjetju Arrow proizvedene izključno po postopku Cipla I. | 610 | Likewise, the definition of ‘the said Citalopram’ in the fourth recital in the Arrow UK preamble is worded so that it cannot be interpreted as referring only to the citalopram that Arrow had already purchased from Tiefenbacher. That recital means that any citalopram covered by Tiefenbacher’s MA was included in the definition of ‘the said Citalopram’. That MA applied to citalopram produced in accordance with the Cipla I and Matrix I processes, irrespective of the fact that the tablets that Arrow had in stock were produced only in accordance with the Cipla I process. |
| 611 | Čeprav je res, da prosilec za ali imetnik DZP lahko organ, ki naj bi ga ali ga je že izdal, zaprosi za spremembe zaradi širitve obsega na druge postopke, tožeči stranki kljub temu utemeljeno trdita, da nič v zadevni uvodni izjavi ne omogoča ugotovitve, da sta stranki sporazuma Arrow UK z opredelitvijo„navedeni Citalopram“ zajeli tudi AFU citalopram, proizveden po postopkih Cipla II in Matrix II, ki nista bila zajeta z „licenco“ iz navedene uvodne izjave. Ta dva postopka bi bila namreč lahko zajeta z DZP družbe Tiefenbacher šele po njegovi spremembi. | 611 | While it is true that the applicant for or holder of an MA may make a request to the authority which is to grant or has granted that MA for variations in order to extend its scope to other processes, the applicants are nevertheless justified in claiming that there is nothing in the recital in question which can establish that the parties to the Arrow UK agreement, when they defined ‘the said Citalopram’, also covered the citalopram API produced in accordance with the Cipla II and Matrix II processes, which were not included in the ‘licence’ referred to in that recital. Those processes could have been covered by Tiefenbacher’s MA only after that MA was varied. |
| 612 | Nazadnje, te razlage ne more ovreči dejstvo – na katero se sklicuje Komisija – da je bila v sklepu s soglasjem podjetja Arrow (točka 36 zgoraj) besedna zveza „navedeni Citalopram“ zamenjana z besedilom „Citalopram, ki ga ne proizvaja družba Lundbeck ali se ne proizvaja po njenem pooblastilu“. Sklep s soglasjem je namreč ne glede na to, da je bil sprejet po sklenitvi sporazuma Arrow UK, od njega ločen pravni instrument. | 612 | Finally, that interpretation is not called into question by the fact, relied on by the Commission, that, in the Arrow consent order (paragraph 36 above), the expression ‘the said Citalopram’ was replaced by the expression ‘Citalopram not manufactured by Lundbeck or with the consent of Lundbeck’. The consent order, although it was adopted following the conclusion of the Arrow UK agreement, is a separate legal instrument from that agreement. |
| 613 | Zato je treba besedno zvezo „navedeni Citalopram“ razlagati tako, da pomeni kateri koli generični citalopram, ki ga proizvaja družba Tiefenbacher po postopkih, ki jih uporabljata družbi Cipla ali Matrix, in ga je podjetje Arrow že kupilo na datum sklenitve sporazuma Arrow UK ali ga bi lahko kupilo v prihodnje in je bil zajet z DZP družbe Tiefenbacher. | 613 | Consequently, ‘the said Citalopram’ must be understood to mean any generic citalopram produced by Tiefenbacher using the processes used by Cipla or Matrix that Arrow had already purchased on the date of signature of the Arrow UK agreement or that it could have purchased subsequently, which was covered by the Tiefenbacher MA. |
| 614 | Tožeči stranki na drugem mestu menita, da jima besedilo „kateri koli drug citalopram, s katerim se po mnenju družbe Lundbeck kršijo njene pravice [intelektualne] lastnine“ iz člena 1.1 sporazuma Arrow UK, ni dajalo pravice do veta, ker naj se ne bi mogli opirati zgolj na uveljavljanje ponarejenosti citaloprama, ki bi ga podjetje Arrow lahko uporabilo, ampak naj bi morali dokazati kršitev njunih patentov prek mehanizma vzorčenja iz navedenega člena, kar naj bi bilo v skladu z napotki iz zgoraj v točki 240 navedene sodbe Paroksetin. V zvezi s tem tožeči stranki izpostavljata, da sporazum Arrow UK ni preprečeval podjetju Arrow, da pred pristojnimi sodišči izpodbija morebitne njune navedbe, da se s citalopramom, ki bi ga podjetje Arrow nameravalo uporabiti, kršijo njuni patenti. | 614 | In the second place, according to the applicants, the expression ‘any other Citalopram which Lundbeck alleges to infringe its [intellectual property] Rights’, used in Article 1.1 of the Arrow UK agreement, does not confer a right of veto on them, as they could not merely rely on the infringing nature of the citalopram that Arrow might seek to use, but would have had to prove that their patents were infringed, by means of the sampling mechanism provided for in that provision, which is consistent with the Paroxetine judgment, cited in paragraph 240 above. In that regard, the applicants emphasise that the Arrow UK agreement did not prevent Arrow from challenging before the competent courts any allegations by the applicants that the citalopram that Arrow might have sought to use infringed their patents. |
| 615 | Opozoriti je treba na to, da je Komisija v točkah 917 ter od 922 do 924 obrazložitve izpodbijanega sklepa presodila, da je zadevno besedilo dopuščalo družbi Lundbeck, da z vetom prepreči podjetju Arrow uvoz ali prodajo citaloprama, proizvedenega po katerem koli postopku, ker je družba Lundbeck lahko zgolj navedla svoje mnenje, da se z določenim postopkom kršijo njene pravice intelektualne lastnine. Komisija je ugotovila tudi, da mehanizem vzorčenja iz člena 1.1 sporazuma Arrow UK nikoli ni bil uporabljen, ker podjetje Arrow ni imelo nobenega interesa za izpodbijanje navedb družbe Lundbeck v zvezi z rezultati morebitnih preizkusov, niti za to, da ji predloži AFU za preizkušanje, dokler je družba Lundbeck opravljala dogovorjena plačila. | 615 | It must be recalled that, inter alia, in recitals 917 and 922 to 924 of the contested decision, the Commission considered that the expression in question allowed Lundbeck to veto the importation or sale by Arrow of citalopram produced using any process, in so far as Lundbeck needed only to declare that it believed that a given process infringed its intellectual property rights. The Commission also noted that the sampling mechanism provided for in Article 1.1 of the Arrow UK agreement had never been used, since Arrow had no interest in challenging Lundbeck’s claims concerning the outcome of possible tests, or even in submitting APIs to it for testing as long as Lundbeck made the agreed payments. |
| 616 | V zvezi s tem je treba izpostaviti – kot utemeljeno opozarja Komisija – da je podjetje Arrow v odgovor na njeno zahtevo za informacije z dne 18. decembra 2008, ki sta jo tožeči stranki predložili v prilogi k tožbi in je bila predmet razprave na obravnavi, priznalo: | „Preizkus iz [člena 1.1 sporazuma Arrow UK] je subjektiven preizkus zatrjevane kršitve in ne dejanska kršitev. Zato bi proizvodi z vsebnostjo citaloprama, v zvezi s katerimi nobeno sodišče ni ugotovilo odsotnosti kršitve [pravic intelektualne lastnine družbe Lundbeck], vendar dejansko ne pomenijo kršitve [teh pravic], lahko bili zajeti v področju uporabe [navedenega člena], ampak to je povsem običajno pri tovrstnih sporazumih.“ | 616 | In that regard, it must be stressed that, as the Commission correctly stated, Arrow, in reply to the Commission’s request for information of 18 December 2008, produced by the applicants themselves in annex to the application and which was a subject of discussion at the hearing, acknowledged the following: | ‘The test established [in Article 1.1 of the Arrow UK agreement] is a subjective test of alleged infringement, not actual infringement. Therefore, citalopram products that have not been found by a court to be non-infringing [of Lundbeck’s intellectual property rights] but do not actually infringe [those rights] could have been within the scope [of that article], but that is entirely usual in agreements of this nature’. |
| 617 | Ta izjava potrjuje tezo Komisije, da je imela družba Lundbeck v bistvu pravico veta. V nasprotju z zatrjevanjem tožečih strank te pravice ni mogoče enačiti s položajem, ki je nastal po zgoraj v točki 240 navedeni sodbi Paroksetin. Poleg preudarkov, navedenih zgoraj v točkah od 258 do 263, je treba ugotoviti, da mehanizem iz člena 1.1 sporazuma Arrow UK ne zajema posega sodišča, v primeru iz navedene sodbe pa je to jasno, vendar si ni mogoče predstavljati, da bi sodišče sprejelo začasni ukrep zgolj na podlagi trditev imetnika domnevno kršenega patenta. | 617 | That statement confirms the Commission’s view that Lundbeck had, in essence, a right of veto. Contrary to what the applicants claim, such a right may not be regarded as equivalent to the situation allegedly created by the judgment in Paroxetine, cited in paragraph 240 above. In addition to the considerations set out in paragraphs 258 to 263 above, it must be observed that the mechanism provided for in Article 1.1 of the Arrow UK agreement does not involve court intervention, while that is clearly the case in the scenario set out in that judgment, it being noted that is inconceivable that a court would adopt an interim measure on the basis of mere allegations made by the holder of a patent alleged to have been infringed. |
| 618 | Ugotoviti je treba tudi, da zaradi obstoja pravice veta ni brezpredmeten tisti del člena 1.1 sporazuma Arrow UK, ki se nanaša na „navedeni Citalopram“, ker družbi Lundbeck v zvezi z zadnjenavedenim svoje pravice veta sploh ni bilo treba izvršiti, ker so se prepovedi za podjetje Arrow glede tega citaloprama uporabljale, ne da bi bilo treba družbi Lundbeck narediti kar koli, razen izvršitve dogovorjenih plačil. | 618 | Moreover, it should be noted that the existence of that right of veto does not render superfluous the part of Article 1.1 of the Arrow UK agreement referring to ‘the said Citalopram’, given that, with regard to that citalopram, Lundbeck did not even have to exercise its right of veto, since the prohibitions imposed on Arrow concerning that citalopram were applicable without Lundbeck having to do anything other than make the payments provided for. |
| 619 | To, da je preizkus iz člena 1.1 sporazuma Arrow UK zaradi svoje subjektivnosti dajal družbi Lundbeck pravico veta, česar se je podjetje Arrow zavedalo, potrjuje neuporaba tega preizkusa med celotnim trajanjem sporazuma. Čeprav je namreč podjetje Arrow med trajanjem tega sporazuma še naprej iskalo nove vire AFU, pa družbi Lundbeck ni nikoli predložilo vzorcev v presojo. | 619 | That the test provided for in Article 1.1 of the Arrow UK agreement, by its subjective nature, served to confer a right of veto on Lundbeck, of which Arrow was aware, is corroborated by the fact that that test was not used at any time during the term of that agreement. Although, during the term of that agreement, Arrow continued to seek other sources of API, it never submitted samples to Lundbeck for examination. |
| 620 | V zvezi s tem je treba ugotoviti, da je mogoče iskanje podjetja Arrow glede tega pojasniti, prvič, z željo po vstopu na trge zunaj Združenega kraljestva. Podjetje Arrow se je namreč na eni strani pripravljalo na vstop na danski trg do sklenitve danskega sporazuma Arrow, kar se je zgodilo več mesecev pred sporazumom Arrow UK. Na drugi strani pa je podjetje Arrow, kot je Komisija navedla v točki 931 obrazložitve izpodbijanega sklepa, zanimal tudi švedski trg. Drugič, podjetje Arrow je potrebovalo alternativo družbi Tiefenbacher za izvedbo svojega načrta, po katerem bi lahko nazadnje samo proizvajalo tablete generičnega citaloprama z nakupom AFU neposredno pri proizvajalcih, brez uporabe posrednikov, kot je družba Tiefenbacher, ki je spreminjala to AFU v tablete (glej opombo 1935 izpodbijanega sklepa). | 620 | As regards that point, first, it must be noted that Arrow’s searches for that purpose can be explained by its intention to enter markets other than that of the United Kingdom. On the one hand, Arrow was preparing its entry to the Danish market up to the time of the conclusion of the Arrow Danish agreement, which took place several months after the Arrow UK agreement. On the other hand, as the Commission noted in recital 931 of the contested decision, Arrow was also interested in the Swedish market. Secondly, Arrow needed an alternative to Tiefenbacher in order to complete its plan to be able eventually to produce generic citalopram tablets itself, by purchasing the API directly from producers without using an intermediary such as Tiefenbacher which transformed that API into tablets (see footnote No 1935 of the contested decision). |
| 621 | Sicer pa bi tako iskanje lahko razkrivalo ukrepe za pripravo na obdobje po poteku sporazuma Arrow UK, ki je bil sprva sklenjen za manj kot leto, nato pa je bil dvakrat podaljšan. Ti preudarki veljajo tudi za to, da je podjetje Arrow med trajanjem sporazuma Arrow UK zahtevalo spremembo DZP, ki se je nanašalo na AFU družb Cipla in Matrix, tako da bi zajemalo tudi postopke Cipla II in Matrix II. | 621 | Moreover, such research could relate to steps taken in preparation for the period after the expiry of the Arrow UK agreement, which was initially concluded for a term of under one year and which was subsequently extended twice. Those considerations also apply in respect of the fact that, during the term of the Arrow UK agreement, Arrow requested a variation of the MA concerning the Cipla and Matrix APIs so that it would also cover the Cipla II and Matrix II processes. |
| 622 | Na podlagi teh preudarkov je mogoče zavrniti tudi trditev tožečih strank, da to, da je podjetje Arrow celo po sklenitvi sporazuma Arrow UK nadaljevalo z iskanjem dobaviteljev, ki bi mu lahko dobavili AFU, s katero se ne bi kršili patenti družbe Lundbeck, potrjuje da se je ta sporazum nanašal samo na citalopram, s katerim so se kršili ti patenti. | 622 | Those findings also make it possible to reject the applicants’ argument that the fact that, even after concluding the Arrow UK agreement, Arrow UK continued to seek suppliers capable of supplying it with an API that did not infringe Lundbeck’s patents confirms that that agreement related only to citalopram that did infringe those patents. |
| 623 | Tožeči stranki na tretjem mestu opozarjata na to, da je treba sporazum Arrow UK v skladu z angleškim pravom, ki ga ureja, razlagati na podlagi njegovega poslovnega namena, po katerem naj bi služil kot alternativa predlogu za začasno odredbo pri nacionalnem sodišču. Taka odredba pa bi se lahko nanašala samo na generični citalopram, s katerim so se kršili patenti družbe Lundbeck. | 623 | In the third place, the applicants note that, under English law, which governs the Arrow UK agreement, that agreement must be interpreted on the basis, in particular, of its commercial purpose, which was to serve as an alternative to an application for an interim injunction before the national court. Such an injunction could have related only to generic citalopram that infringed Lundbeck’s patents. |
| 624 | Vendar je treba ugotoviti, da sklicevanje tožečih strank na načela angleškega prava v zvezi z razlago pogodb ne more ovreči razlage, ki jo je sprejela Komisija. | 624 | It must be observed, however, that the reference made by the applicants to the principles of English law concerning the interpretation of contracts does not call into question the Commission’s interpretation. |
| 625 | Res je, da je vprašanje razlage nacionalnega prava države članice dejansko vprašanje, v zvezi s katerim mora Splošno sodišče načeloma opraviti popolni nadzor (točka 258 zgoraj). | 625 | It is true that a question relating to the interpretation of the national law of a Member State is a question of fact concerning which the Court must, in principle, carry out a comprehensive review (paragraph 258 above). |
| 626 | Vendar je bil poslovni cilj družbe Lundbeck, ki ga podjetje Arrow ni moglo zanemariti, da zadnjenavedenemu prepreči vstop na trg z generičnim citalopramom. Prav zaradi tega je družba Lundbeck plačala podjetju Arrow zneske, povezane z donosom, ki si ga je zadnjenavedeno obetalo z vstopom na trg. Zato ni presenetljivo, da sta se stranki sporazuma Arrow UK strinjali, da zagotovita družbi Lundbeck pravico veta, ki jo je bilo mogoče uporabiti tudi zoper citalopram, proizveden po postopkih Cipla II in Matrix II. | 626 | However, Lundbeck’s commercial objective, of which Arrow could not have failed to be aware, was to prevent Arrow from entering the market with generic citalopram. That is why Lundbeck paid Arrow amounts linked to the profits it hoped to obtain by entering the market. Under these circumstances, it is not surprising that the parties to the Arrow UK agreement agreed to grant Lundbeck a right of veto, which could also be used against citalopram produced in accordance with the Cipla II and Matrix II processes. |
| 627 | V resnici je tako plačilo težko združljivo z ohranitvijo možnosti podjetja Arrow, da začne prodajati citalopram, ki ni „navedeni citalopram“, torej tisti, proizveden po postopkih Cipla I in Matrix I. Če bi bilo drugače, bi podjetje Arrow lahko ne samo uživalo koristi od plačil družbe Lundbeck, ampak tudi donos od vstopa na trg, na primer z generičnim citalopramom, proizvedenim po postopkih Cipla II in Matrix II, družba Lundbeck pa bi morala nositi tako breme plačila kot izgube zaradi navedenega vstopa. | 627 | In fact, such a payment was hardly compatible with Arrow’s retaining the freedom to begin selling citalopram other than ‘the said Citalopram’, namely that produced in accordance with the Cipla I or Matrix I processes. Had it been otherwise, Arrow could have enjoyed not only payments made by Lundbeck but also the benefits of market entry, for example with generic citalopram produced in accordance with the Cipla II or Matrix II processes, while Lundbeck would have had to bear both the payments and the losses arising from that entry. |
| 628 | Na četrtem mestu, tožeči stranki trdita, da Komisija o področju uporabe sporazuma Arrow UK ne more sklepati na podlagi člena 3 druge priloge k temu sporazumu, po katerem bi morali, če bi se v sporu Lagap izkazalo, da patent za kristalizacijo ni veljaven, podjetju Arrow plačati 750.000 GBP za dobavo tablet, ki jih je zadnjenavedeno še imelo na zalogi. To plačilo bi bilo namreč utemeljeno s tem, da je veljavnost zadevnih tablet potekla oktobra 2003, čeprav jih podjetje Arrow nikoli ni moglo prodati na trgu. Sicer pa tožeči stranki uveljavljata nedopustnost tega očitka Komisije, ker ga ni uveljavljala niti v izpodbijanem sklepu niti v obvestilu o ugotovitvah o možnih kršitvah. | 628 | In the fourth place, the applicants claim that the Commission cannot draw any conclusion, as regards the scope of the Arrow UK agreement, from Article 3 of the second addendum to that agreement, according to which, in the event that the Lagap litigation showed that the crystallisation patent was invalid, they would have to pay Arrow GBP 750000 to deliver up its remaining stock of tablets. That payment was justified by the fact that the validity of the tablets in question expired in October 2003, so that it would not have been possible for Arrow to sell them on the market. Furthermore, the applicants claim that the Commission’s objection is inadmissible, since it was not raised in either the contested decision or the statement of objections. |
| 629 | V zvezi s tem je treba ugotoviti, da je ta trditev brezpredmetna, ker razlaga področja uporabe sporazuma Arrow UK iz izpodbijanega sklepa nikakor ne temelji na členu 3 druge priloge k temu sporazumu. Komisija se je na ta člen opirala šele pred Splošnim sodiščem in ga je zgolj omenila v točki 441 obrazložitve izpodbijanega sklepa, ne da bi na njegovi podlagi sklepala o čemer koli. | 629 | In that regard, it must be observed that that argument is ineffective, since the interpretation of the scope of the Arrow UK agreement adopted in the contested decision is in no way based on Article 3 of the second addendum to that agreement. It was only before the Court that the Commission relied on that article, which it merely referred to in recital 441 of the contested decision, without drawing any inferences from it. |
| 630 | Iz navedenega sledi, da Komisija ni storila napake s tem, da je člen 1.1 sporazuma Arrow UK razlagala tako, da je podjetju Arrow preprečeval vstop na trg Združenega kraljestva med trajanjem tega sporazuma, in to ne samo z generičnim citalopramom, ki ga je že naročilo pri družbi Tiefenbacher, pač pa tudi s katerim koli drugim generičnim citalopramom, ki bi ga morda pridobilo pozneje, tudi tistim, proizvedenim po postopkih Cipla II in Matrix II. | 630 | It follows from the foregoing that the Commission did not err in interpreting Article 1.1 of the Arrow UK agreement as seeking to prevent Arrow from entering the United Kingdom market during the term of that agreement, not only with generic citalopram which it had already ordered or purchased from Tiefenbacher, but also with any other generic citalopram that it could have obtained subsequently, including generic citalopram produced in accordance with the Cipla II and Matrix II processes. |
| 631 | Zato je treba ta očitek zavrniti. | 631 | Accordingly, the present complaint must be rejected. |
| 4. Danski sporazum Arrow | 4. The Arrow Danish agreement |
| 632 | Tožeči stranki trdita, da je Komisija storila očitno napako pri presoji s tem, da je danski sporazum Arrow razlagala tako, da je podjetju Arrow preprečeval prodajo vseh oblik generičnega citaloprama med trajanjem tega sporazuma, ki se je nanašal samo na citalopram, s katerim so bili kršeni njuni patenti. | 632 | The applicants claim that the Commission made a manifest error of assessment in interpreting the Arrow Danish agreement as preventing Arrow from selling any form of generic citalopram during the term of that agreement, which applied only to citalopram infringing their patents. |
| 633 | Prvič, člen 1.1 danskega sporazuma Arrow (glej zgoraj, točka 39, druga alineja) naj bi se v povezavi s preambulo in splošnim okvirom tega sporazuma nanašal samo na citalopram, ki ga je podjetje Arrow že uvozilo in sta ga tožeči stranki že laboratorijsko preizkusili. Šlo naj bi torej za citalopram družbe Tiefenbacher, s katerim so bili kršeni njuni patenti. | 633 | First, Article 1.1 of the Arrow Danish agreement (see the second indent of paragraph 39 above), read in the light of the preamble to and the general context of that agreement, refers only to the citalopram that Arrow had already imported and which the applicants had subjected to laboratory tests. It therefore relates to citalopram originating from Tiefenbacher, which infringed their patents. |
| 634 | Drugič, tožeči stranki trdita, da je treba v skladu z danskim pravom, ki ureja ta sporazum, poseben pomen pripisati skupni volji strank, ki je bila zagotovitev spoštovanja patentov tožečih strank. Preširoka razlaga Komisije naj bi bila zato v nasprotju z danskim pravom. | 634 | Secondly, the applicants submit that, under Danish law, which governs that agreement, particular importance must be placed on the common intention of the parties, which was to ensure compliance with the applicant’s patents. The Commission’s over-extensive interpretation is therefore contrary to Danish law. |
| 635 | Tretjič, tožeči stranki se opirata na podobne utemeljitve, kot so tiste, navedene v zvezi s sporazumom Arrow UK, zlasti v zvezi s tem, da je podjetje Arrow nadaljevalo z iskanjem drugih virov AFU in imelo možnost predlagati nacionalnemu sodišču, naj se izreče o morebitni nekršitvi njunih patentov. | 635 | Thirdly, the applicants put forward arguments similar to those referred to with respect to the Arrow UK agreement, particularly concerning the fact that Arrow had continued to seek other sources of API and could have sought a declaration from a national court that there was no infringement of the applicants’ patents. |
| 636 | Četrtič, tožeči stranki trdita, da če danski sporazum Arrow in sporazum Arrow UK pomenita enotno in nadaljevano kršitev, kot je navedeno v izpodbijanem sklepu, potem ni možno, da se prvi nanaša tudi na neponarejeni citalopram, drugi pa ne. | 636 | Fourthly, the applicants claim that if the Arrow Danish agreement and the Arrow UK agreement constitute a single and continuous infringement, as the contested decision alleges, it is inconceivable that the former should also apply to non-infringing citalopram, when the latter does not. |
| 637 | Komisija te trditve zavrača. | 637 | The Commission disputes those arguments. |
| 638 | Opozoriti je treba, da se člen 1.1 danskega sporazuma Arrow glasi: | „Družba Arrow [Group] soglaša, da bo prenehala z uvozom, izdelavo, proizvodnjo, prodajo ali drugim trženjem proizvodov z vsebnostjo citaloprama, s katerim se po mnenju družbe Lundbeck kršijo njene pravice intelektualne lastnine na ozemlju [Danske] med trajanjem [danskega sporazuma].“ | 638 | It must be noted that Article 1.1 of the Arrow Danish agreement states as follows: | ‘Arrow [Group] consents to cancel, cease and desist from any importation, manufacture, production, sale or other marketing of products containing citalopram which Lundbeck alleges to infringe its intellectual property rights in the territory [of Denmark] for the term of [the Danish agreement]’. |
| 639 | Tožeči stranki trdita, da je mogoče na podlagi preambule danskega sporazuma Arrow sklepati, da je treba navedeni člen razlagati tako, da se nanaša samo na citalopram, ki sta ga tožeči stranki že kupili pri družbi Tiefenbacher. | 639 | The applicants maintain that the preamble to the Arrow Danish agreement shows that that point must be interpreted as meaning that it concerns only the citalopram that Arrow had already purchased from Tiefenbacher. |
| 640 | Res je, da se v tretji in peti uvodni izjavi preambule danskega sporazuma Arrow glede na pojasnila v zvezi z njima iz točke 986 obrazložitve izpodbijanega sklepa, ki jih tožeči stranki ne izpodbijata, omenja dejstvo, da je bilo podjetje Arrow tik pred nakupom DZP, ki bi mu omogočalo, da na Danskem prodaja generični citalopram, proizveden na podlagi AFU družbe Cipla ali Matrix, ki ga je družba Lundbeck laboratorijsko preizkusila. V četrti uvodni izjavi navedene preambule je omenjena tudi namera podjetja Arrow, da iz Nemčije na Dansko uvozi nepakirani citalopram družbe Tiefenbacher. | 640 | It should be noted that it is true that the third and fifth recitals in the preamble to the Arrow Danish agreement, read in the light of the clarifications concerning them in recital 986 of the contested decision, which were not called into question by the applicants, refer to the fact that Arrow was about to purchase an MA which would have allowed it to sell in Denmark generic citalopram produced from the Cipla or Matrix API and which had been subjected to laboratory tests by Lundbeck. The fourth recital in that preamble also refers to Arrow’s intention to export bulk citalopram originating from Tiefenbacher from Germany to Denmark. |
| 641 | Vendar te omembe, čeprav pojasnjujejo okvir danskega sporazuma Arrow, ne zadostujejo za ovrženje jasnega besedila člena 1.1, katerega področja uporabe ni mogoče omejiti tako, kot predlagata tožeči stranki. | 641 | However, those references, while they explain the context in which the Arrow Danish agreement took place, are not sufficient to call into question the clear wording of Article 1.1, whose scope cannot be reduced to that proposed by the applicants. |
| 642 | Če bi namreč stranki tega sporazuma želeli omejiti obseg njegovih obveznosti v zvezi s citalopramom, ki ga je podjetje Arrow imelo na zalogi, bi se lahko za ta namen odločili za prilagoditev besedila, namesto da sta se odločili za zelo široko besedilo, katerega obseg je bilo treba omejiti z razlago v skladu z uvodnimi izjavami preambule, iz katerih besedila pa sicer ni jasna želja za uvedbo omejitev. | 642 | If the parties to that agreement had wished to reduce the scope of the obligations covered by it to the citalopram that Arrow had in stock, they could have chosen wording suitable for that purpose, instead of choosing wording which was very broad, whose scope had to be restricted by an interpretation in the light of the recitals in the preamble, which, moreover, did not express the clear intention to introduce restrictions. |
| 643 | Kar zadeva posebej sklicevanje tožečih strank na pomen skupne volje strank po danskem pravu, ki ureja zadevni sporazum, je treba ugotoviti, da tožeči stranki nista predložili nobenega dokaza, da je bila ta volja drugačna od tiste, ki jasno izhaja iz besedila sporazuma in ni v neskladju z uvodnimi izjavami njegove preambule. | 643 | As regards, more particularly, the reference by the applicants to the importance of the shared intention of the parties under Danish law, which governs the agreement in question, it must be noted that the applicants have not provided any evidence that that intention differed from the intention that was clearly apparent from the text of the agreement and which was not called into question by the recitals in its preamble. |
| 644 | Sicer pa ne more uspeti niti trditev tožečih strank, da sta oba sporazuma, ki sta ju sklenili s podjetjem Arrow, enotna in nadaljevana kršitev, zato bi bilo treba priznati omejeno področje uporabe danskega sporazuma Arrow zaradi skladnosti s sporazumom Arrow UK. Zadnjenavedeni sporazum namreč nima omejenega področja uporabe, kot mu ga pripisujeta tožeči stranki, kot izhaja iz analize v točkah od 604 do 629 zgoraj. | 644 | Moreover, the applicants’ argument that, since both agreements that they concluded with Arrow constitute a single and continuous infringement, the Arrow Danish agreement should be recognised as having a restricted scope for reasons of consistency with the Arrow UK agreement, cannot succeed either. Indeed, that agreement does not have the restricted scope that the applicants attribute to it, as is clear from the examination carried out in paragraphs 604 to 629 above. |
| 645 | Zato je treba skleniti, da Komisija ni storila nobene napake pri presoji, ko je člen 1.1 danskega sporazuma Arrow razlagala tako, da podjetje Arrow med njegovim trajanjem ne bo vstopilo na danski trg z nobenim citalopramom. | 645 | Accordingly, it must be concluded that the Commission made no error of assessment in considering that Article 1.1 of the Arrow Danish agreement should be interpreted as meaning that Arrow would not enter the Danish market during the term of that agreement with any generic citalopram. |
| 646 | Ob upoštevanju navedenih preudarkov je treba četrti del zavrniti. | 646 | In the light of the foregoing considerations, the fourth part must be rejected. |
| 5. Sporazum Alpharma | 5. The Alpharma agreement |
| 647 | Tožeči stranki trdita, da je Komisija storila očitno napako pri presoji s stališčem, da je sporazum Alpharma temu podjetju prepovedoval prodajati kateri koli citalopram med trajanjem tega sporazuma, ki naj bi se nanašal samo na generični citalopram, proizveden s kršitvijo patentov družbe Lundbeck, vključno s tistimi iz priloge A. | 647 | The applicants claim that the Commission made a manifest error of assessment in taking the view that the Alpharma agreement prohibited Alpharma from selling any form of generic citalopram during the term of that agreement, which related only to generic citalopram produced in breach of Lundbeck’s patents, including those listed in Appendix A. |
| 648 | Komisija te trditve zavrača. | 648 | The Commission disputes those arguments. |
| 649 | Ugotoviti je treba, da je Komisija v točkah 1042, 1059 in 1061 obrazložitve izpodbijanega sklepa razlagala člen 1.1 sporazuma Alpharma tako, da se je podjetje Alpharma z njim zavezalo, da v upoštevnem obdobju ne bo prodajalo nobenega citaloprama ali vsaj, da je soglašalo z omejenimi možnostmi za prodajo citaloprama, ki so precej presegale tiste, ki bi jih družba Lundbeck lahko dosegla prek sodnih postopkov na podlagi svojih novih patentov. | 649 | It must be noted that, inter alia in recitals 1042, 1059 and 1061 of the contested decision, the Commission interpreted Article 1.1 of the Alpharma agreement as meaning that, by that agreement, Alpharma had agreed not to sell any citalopram during the relevant period, or, at least, had accepted restrictions on its ability to sell citalopram which greatly exceeded the restrictions that Lundbeck could have obtained by means of litigation on the basis of its new patents. |
| 650 | Tožeči stranki na prvem mestu trdita, da je treba člen 1.1 sporazuma Alpharma razlagati ob upoštevanju okoliščin in razpoložljivih dokazov, na podlagi katerih je mogoče sklepati, da izraz „Citalopram“ v njem zajema samo citalopram, s katerim se kršijo njuni patenti. Ta razlaga naj bi izhajala iz razumevanja preambule sporazuma Alpharma in priloge A, v skladu s katerima je bil tak namen strank tega sporazuma. | 650 | The applicants maintain, in the first place, that the wording of Article 1.1 of the Alpharma agreement must be interpreted in the light of its context and the available evidence, from which it may be concluded that the word ‘Citalopram’ contained therein refers only to citalopram infringing their patents. That interpretation follows from a reading of the preamble to the Alpharma agreement and of Appendix A, which show that such was the intention of the parties to that agreement. |
| 651 | V zvezi s tem je treba opozoriti, da člen 1.1 sporazuma Alpharma določa, da podjetje Alpharma, vključno z njegovimi „Hčerinskimi družbami“, „preneha in se vzdrži vsakršnega uvoza, […] proizvodnje […] ali prodaje farmacevtskih proizvodov z vsebnostjo Citaloprama na Ozemlju […] v [upoštevnem obdobju]“, in da bo družba Lundbeck umaknila tožbo zaradi kršitev zoper podjetje Alpharma. V njem je tudi pojasnjeno, da se ta člen ne uporablja za „kateri koli proizvod z vsebnostjo escitaloprama“. | 651 | Article 1.1 of the Alpharma agreement stipulates that Alpharma, and its ‘[a]ffiliates’, ‘shall cancel, cease and desist from any importation, … production, … or sale of pharmaceutical products containing Citalopram in the Territory … during [the relevant period]’ and that Lundbeck is to withdraw the infringement action against Alpharma. It also states that that article does not apply to ‘any product containing escitalopram’. |
| 652 | Ugotoviti je treba, da se v sporazumu Alpharma, tudi v členu 1.1, ves čas uporablja beseda „Citalopram“ pisan z veliko tiskano črko „c“. Podobno se v tem sporazumu uporabljajo besede z veliko začetnico, kadar gre za opredeljene pojme kot na primer „Ozemlje“ iz druge uvodne izjave preambule in „Hčerinske družbe“ iz navedenega člena 1.1. Ti opredeljeni pojmi pa so izrecno določeni z natančno opredelitvijo njihovega obsega tam, kjer se prvič pojavijo. Jasno je torej, da je „Ozemlje“ pojem, ki označuje celoto, ki jo tvorijo države članice, Norveška in Švica, pojem „Hčerinske družbe“ pa se nanaša na vsako družbo, ki neposredno ali posredno nadzira, je pod nadzorom ali skupnim nadzorom z družbo Alpharma ApS. | 652 | It must be noted that the Alpharma agreement, including in Article 1.1, always uses the term ‘Citalopram’ with an upper case ‘C’. Likewise, that agreement uses words written with an initial upper case letter where it employs defined terms, as is the case with the words ‘Territories’ in the second recital in the preamble and ‘Subsidiaries’ in the abovementioned Article 1.1. However, those defined terms are set out explicitly, with a precise definition of their scope where they first appear. It is therefore clear that ‘Territories’ is a term used to refer to the group formed by the EU Member States, Norway and Switzerland, and the term ‘Affiliates’ refers to any company which, directly or indirectly, controls or is controlled or is under common control with Alpharma ApS. |
| 653 | Nasprotno pa sporazum Alpharma ne vsebuje nobene opredelitve pojma „Citalopram“, na podlagi katere bi mu bilo mogoče pripisati ožji pomen, kot ga ima splošno mednarodno poimenovanje citaloprama kot AFU, ki jo priznava Svetovna zdravstvena organizacija (WHO), kakor ugotavlja Komisija. | 653 | By contrast, the Alpharma agreement contains no definition of the term ‘Citalopram’ which would enable a more restrictive meaning to be attributed to that term than that of its international non-proprietary name of citalopram, as an API recognised by the World Health Organisation (WHO), as the Commission notes. |
| 654 | Sicer pa dejstvo, kot v točki 1050 obrazložitve izpodbijanega sklepa utemeljeno opozarja Komisija, da člen 1.1 sporazuma Alpharma na koncu določa, da se ne uporablja za escitalopram, potrjuje, da sta stranki tega sporazuma, kadar sta želeli omejiti obseg obveznosti na podlagi navedenega člena, to izrecno storili. | 654 | Moreover, as the Commission stated correctly in recital 1050 of the contested decision, the fact that Article 1.1 of the Alpharma agreement, provides, at the very end, that it does not apply to escitalopram confirms that, where the parties to that agreement wished to restrict the scope of the obligations arising from that article, they did so explicitly. |
| 655 | V zvezi s tem pa je treba ugotoviti – kot izpostavljata tožeči stranki – da odsotnost velike tiskane črke „e“ v besedi „escitalopram“, kaže na nedosledno zapisovanje besed v sporazumu Alpharma pri navajanju AFU, zato to ne zadostuje za sklep, da sta stranki tega sporazuma želeli omejiti obseg besede „Citalopram“. | 655 | In that regard, while the absence, highlighted by the applicants, of an upper case ‘e’ in the word ‘escitalopram’ reveals inconsistency in the spelling of words used in the Alpharma agreement to refer to APIs, it must be observed, however, that that fact is not sufficient to consider that the parties to that agreement wished to restrict the scope of the word ‘Citalopram’. |
| 656 | Dalje, v zvezi s preambulo sporazuma Alpharma je treba ugotoviti, da je v njeni prvi uvodni izjavi navedeno, da je „družba Lundbeck imetnica pravic intelektualne lastnine, ki med drugim zajemajo patente v zvezi s proizvodnjo AFU Citalopram, vključno s patenti iz priloge A“. | 656 | Next, as regards the preamble to the Alpharma agreement, it should be noted that the first recital in that preamble states that ‘Lundbeck owns intellectual property rights including, in particular, patent rights relating to the manufacture and production of the active chemical substance Citalopram, including the patents set out in Appendix A hereto’. |
| 657 | Iz sedme uvodne izjave preambule sporazuma Alpharma izhaja, da je družba Lundbeck zoper podjetje Alpharma vložila tožbo zaradi kršitev „s katero je predlagala, naj se [podjetju] Alpharma prepove prodaja proizvodov z vsebnostjo Citaloprama zaradi kršitve pravic intelektualne lastnine družbe Lundbeck“. | 657 | It follows from the seventh recital in the preamble to the Alpharma agreement that Lundbeck had lodged an action for infringement against Alpharma ‘seeking an injunction against sales [by the Alpharma group] of products containing Citalopram for infringing Lundbeck’s intellectual property rights’. |
| 658 | Nazadnje, iz osme uvodne izjave preambule izhaja, da je podjetje Alpharma priznalo, da so ugotovitve družbe Lundbeck v zvezi s kršitvijo njenih patentov pravilne, in se zavezalo, da „takih proizvodov“ ne bo dajalo na trg. | 658 | Finally, according to the eighth recital in the preamble, Alpharma acknowledged that the findings by Lundbeck in relation to the infringement of its patents were correct and that it undertook not to place ‘such products’ on the market. |
| 659 | V zvezi s tem je treba ugotoviti – kot je Komisija v bistvu ugotovila v točki 1047 obrazložitve izpodbijanega sklepa – da zgolj na podlagi sklicevanja v prvi uvodni izjavi preambule na to, da ima družba Lundbeck patente v zvezi s „Citalopramom“, ki so navedeni v prilogi A, ni mogoče sklepati, da sta stranki sporazuma – pa čeprav posredno – želeli v njej opredeliti besedo „Citalopram“ tako, da to ne bi ustrezalo običajni opredelitvi citaloprama brez velike tiskane črke „c“, torej AFU citalopram, ne glede na postopek njene proizvodnje. | 659 | It must be observed in that regard, as the Commission noted in essence in recital 1047 of the contested decision, that the mere reference, in the first recital in the preamble, to the fact that Lundbeck owned patents relating to ‘Citalopram’, which are listed in Appendix A, does not allow the conclusion that the parties to the Alpharma agreement intended, even if only implicitly, to include a definition of the word ‘Citalopram’ which would not coincide with that normally attributable to citalopram without an upper case ‘c’, namely the citalopram API, irrespective of the process used to produce it. |
| 660 | Poleg tega je – kot je Komisija izpostavila v točkah od 1047 do 1049 izpodbijanega sklepa – v sedmi in osmi uvodni izjavi preambule resda opozorjeno na okoliščine nastanka sporazuma Alpharma, vendar ti nista odločilni za pripis ožjega pomena besede „Citalopram“. V sedmi uvodni izjavi namreč na eni strani navedena beseda ni opredeljena, ampak je tam omenjen predlog za začasno odredbo o prepovedi prodaje proizvodov z vsebnostjo „Citaloprama“ zaradi kršitve patentov družbe Lundbeck. Na drugi strani, tudi če se v osmi uvodni izjavi besedna zveza „taki proizvodi“ nanaša izključno na proizvode z vsebnostjo citaloprama, sintetiziranega po postopkih, na katere se nanaša navedeni predlog in glede katerih je podjetje Alpharma priznalo, da so ponarejeni, na podlagi tega ni mogoče sklepati, da beseda „Citalopram“ v celotnem sporazumu Alpharma, vključno s členom 1.1, zajema zgolj te proizvode. | 660 | Furthermore, as the Commission observed in recitals 1047 to 1049 of the contested decision, the seventh and eighth recitals of the preamble do indeed recall the context in which the Alpharma agreement took place but are not decisive in terms of their ability to attribute restricted meaning to the word ‘Citalopram’. First, the seventh recital is not worded in terms defining that word, but refers to an application for an injunction prohibiting the sale of products containing ‘Citalopram’ on account of the infringement of patents belonging to Lundbeck. Secondly, even if, in the eighth recital, the expression ‘such products’ only covers products containing citalopram synthesised using processes covered by that application for an injunction whose infringing nature Alpharma acknowledged, that fact does not allow the conclusion that, within the entire Alpharma agreement, including Article 1.1 thereof, the word ‘Citalopram’ only included those products. |
| 661 | Zato brez jasnih omejitev pomena izraza „Citalopram“ v preambuli ni mogoče samo na podlagi sklicevanja na okoliščine sklenitve sporazuma Alpharma sklepati, da sta stranki tega sporazuma želeli omejiti obseg obveznosti podjetja Alpharma samo na citalopram, za katerega je priznalo, da so bili z njegovo proizvodnjo kršeni novi patenti družbe Lundbeck. | 661 | Accordingly, in the absence of clear restrictions in the meaning of the word ‘Citalopram’ arising from the preamble, it may not be considered that, by mere references to the background to the conclusion of the Alpharma agreement, the parties to that agreement intended to restrict the scope of the obligations assumed by Alpharma solely to the citalopram acknowledged to have been produced in breach of Lundbeck’s new patents. |
| 662 | Tožeči stranki se na drugem mestu opirata na dejstvo, da se je želelo z navedenim sporazumom rešiti spor med njima in podjetjem Alpharma prav zaradi njegove kršitve patentov. Omenjata tudi pomen spora Lagap. | 662 | In the second place, the applicants rely on the fact that that agreement was intended to settle a dispute between them and Alpharma specifically relating to Alpharma’s infringement of their patents. They also refer to the significance of the Lagap litigation. |
| 663 | V zvezi s tem je treba ugotoviti, prvič, da to, da je bil sporazum Alpharma sklenjen po tem, ko sta tožeči stranki vložili tožbo zaradi kršitev podjetja Alpharma, ki se je nanašala konkretno na tablete, ki jih je to podjetje že prejelo ali naročilo, ne pomeni, da je treba obveznosti iz člena 1.1 tega sporazuma kljub njegovemu širokemu besedilu razlagati tako, da so omejene na tisto, kar bi tožeči stranki lahko dosegli z navedeno tožbo. Drugič, s sporazumom Alpharma se navedeni postopek ni končal, ampak je bil samo prekinjen za upoštevno obdobje, brez jamstva za umik tožbe po njegovem koncu. Sporazum Alpharma namreč nikjer ne določa, da bo družba Lundbeck v prihodnje opustila postopanje zoper podjetje Alpharma zaradi kršitev njenih patentov. Poleg tega iz izjave družbe Lundbeck v točki 80 obrazložitve izpodbijanega sklepa izhaja njeno stališče, da sporni sporazumi, tudi sporazum Alpharma, ne rešujejo nobenega spora. Tretjič, spor Lagap, ki se je začel oktobra 2002, kakor izhaja iz točke 63 obrazložitve izpodbijanega sklepa, nikakor ne more vplivati na obseg obveznosti iz člena 1.1 sporazuma Alpharma. | 663 | In that regard, it must be observed, first, that the fact that the Alpharma agreement took place after the launch of the applicants’ infringement action against Alpharma, which specifically concerned tablets that that undertaking had already received or ordered, does not mean that the obligations set out in Article 1.1 of that agreement, despite its broad wording, must be interpreted as being restricted to what the applicants could have obtained from that action. Secondly, the Alpharma agreement did not resolve that action, which was simply suspended for the term of the Alpharma agreement, with no guarantee that it would be withdrawn at the end of that period. The Alpharma agreement does not provide that Lundbeck should subsequently refrain from pursuing the Alpharma group for infringement of its patents. Moreover, it is clear from Lundbeck’s statement cited in recital 80 of the contested decision that it did not consider that the agreements at issue, including the Alpharma agreement, resolved any disputes. Thirdly, the Lagap litigation, which began in October 2002, as is clear from recital 63 of the contested decision, can have no effect on the scope of the obligations arising from Article 1.1 of the Alpharma agreement. |
| 664 | Tožeči stranki se na tretjem mestu opirata na izjavo generalnega direktorja podjetja Alpharma, zadolženega za upoštevno zadevo, na tiskovni konferenci 28. februarja 2002 (v nadaljevanju: izjava z dne 28. februarja 2002), v kateri naj bi omenil, da je bilo dajanje generičnega citaloprama na trg odloženo, vendar ni bilo izključeno, da bi se lahko zgodilo po poletnih dopustih, če bi bile težave z novimi patenti družbe Lundbeck medtem razrešene. Ta izjava naj bi ob upoštevanju trajanja sporazuma Alpharma potrjevala, da se člen 1.1 ne nanaša na vsakršen citalopram. | 664 | In the third place, the applicants rely on a statement made to the press by the chief executive officer of Alpharma responsible for the relevant file on 28 February 2002 (‘the statement of 28 February 2002’), which mentions that the launch of the generic citalopram had been postponed, but that it was not precluded from taking place after the summer holidays, if the problems arising from Lundbeck’s new patents were resolved in the meantime. In view of the duration of the Alpharma agreement, the applicants maintain that that statement confirms that Article 1.1 of the Alpharma agreement did not refer to every type of citalopram. |
| 665 | Ugotoviti je treba, da je podjetje Alpharma z izjavo z dne 28. februarja 2002 v bistvu najavilo medijem, da bo odložilo prodajo citaloprama vsaj do konca poletnih dopustov in da bi lahko po potrebi opustilo projekt v zvezi s to prodajo, ker je njegova zaloga problematična z vidika patentov družbe Lundbeck. Dodalo je, da bo moralo poiskati drugega proizvajalca AFU in pridobiti potrebna dovoljenja. | 665 | It must be observed that, by the statement of 28 February 2002, Alpharma announced, in essence, that it would postpone the launch of sales of citalopram until at least the end of the summer holiday and that it might, if necessary, abandon that planned launch, on the ground that there was a problem with its stock in view of Lundbeck’s patents. It added that it had to seek a new API producer and obtain the necessary authorisations. |
| 666 | V zvezi s tem je treba ugotoviti – kot je Komisija ugotovila v točki 1055 obrazložitve izpodbijanega sklepa – da je iz te izjave, poznejše od sklenitve sporazuma Alpharma, razvidna sprememba načrtov podjetja Alpharma kot posledica njegove enostranske odločitve, neodvisne od plačila iz sporazuma Alpharma. Zato taka izjava, ob upoštevanju preudarkov iz točk 138 in 139 zgoraj, ne more imeti velike dokazne vrednosti, še posebej ker je podjetje Alpharma, ki je tajno privolilo v omejitve svoje poslovne svobode iz sporazuma Alpharma v zameno za tam določena plačila, moralo utemeljiti, pa čeprav samo svojim potencialnim strankam, spremembe prej najavljenih načrtov. Iz tega sledi, da izjava z dne 28. februarja 2002 ni pomemben element okvira za razlago področja uporabe sporazuma Alpharma. | 666 | It must be noted in that regard that, as the Commission stated in recital 1055 of the contested decision, that statement, which is dated after the conclusion of the Alpharma agreement, shows Alpharma’s change of plans as being the consequence of a unilateral decision on its part, separate from the payments provided for in the Alpharma agreement. Accordingly, in the light of the considerations set out in paragraphs 138 and 139 above, such a press release cannot have significant evidential value, particularly since Alpharma, which had accepted in secret restrictions on its commercial independence arising from the Alpharma agreement against the payments provided for therein, had to justify, if only to its potential customers, the changes to the plans it had announced previously. It follows that the statement of 28 February 2002 is not a significant contextual element in interpreting the scope of the Alpharma agreement. |
| 667 | Vsekakor je treba ugotoviti, da je podjetje Alpharma sicer omenilo možnost vstopa na trg po poletju, vendar je omenilo tudi možnost opustitve projekta, ki je v skladu z razlago sporazuma Alpharma, ki jo je sprejela Komisija. | 667 | In any event, it must be observed that, although Alpharma mentioned the possibility of entering the market after the summer, it also referred to the possibility of abandoning the project, a possibility which is in line with the Commission’s interpretation of the Alpharma agreement. |
| 668 | V teh okoliščinah navedena izjava ne omogoča sklepanja, da se je člen 1.1 sporazuma Alpharma nanašal samo na citalopram, proizveden po postopkih, katerih ponarejenost je bila potrjena. | 668 | Under those circumstances, that press release does not allow the conclusion that Article 1.1 of the Alpharma agreement concerned only citalopram produced in accordance with processes acknowledged to be infringing. |
| 669 | Tožeči stranki se na četrtem mestu sklicujeta na sklep s soglasjem podjetja Alpharma (glej točko 45 zgoraj), katerega vsebina naj bi bila upoštevna pri razlagi člena 1.1 sporazuma Alpharma, ker naj bi bil ta sklep sprejet zato, da bi se postopek zaradi kršitev podjetja Alpharma ustavil. Tožeči stranki v zvezi s tem izpostavljata, da je v tem sklepu pojasnjeno, da je obseg omejitev podjetja Alpharma omejen na citalopram, s katerim se kršijo njuni patenti. Poleg tega tožeči stranki izpodbijata utemeljitev iz izpodbijanega sklepa, da je bil sklep s soglasjem podjetja Alpharma zapisan bolj omejujoče kot člen 1.1 sporazuma Alpharma, ker bi ga sodišče sicer težko potrdilo. Izpostavljata, da bi sodišče enako težko zagotovilo spoštovanje tega člena, kakor ga je razlagala Komisija. | 669 | In the fourth place, the applicants refer to the Alpharma consent order (see paragraph 45 above), the terms of which are relevant for the purpose of interpreting Article 1.1 of the Alpharma agreement, in so far as that order was made in order to put an end to the Alpharma infringement proceedings. In that respect, the applicants maintain that that order states that the scope of the restrictions placed on Alpharma is limited to citalopram infringing their patents. Further, the applicants dispute the argument set out in the contested decision that the Alpharma consent order was drafted in more restrictive terms than those of Article 1.1 of the Alpharma agreement on the ground that it would otherwise have been difficult for a court to uphold it. They observe that it would also be difficult for a court to ensure compliance with that provision, as it was interpreted by the Commission. |
| 670 | V zvezi s tem je sicer res, da je sklep s soglasjem z dne 2. maja 2002 zapisan tako, kot sta navedli tožeči stranki (točka 45 zgoraj), iz česar jasno izhajajo manj obsežne omejitve ravnanja podjetja Alpharma, kot so tiste iz člena 1.1 sporazuma Alpharma, kakor ga je v izpodbijanem sklepu razložila Komisija. | 670 | In that regard, it is indeed true that the Alpharma consent order of 2 May 2002 is worded in the terms referred to by the applicants (paragraph 45 above) which clearly include restrictions on Alpharma’s conduct which are less broad than those arising from Article 1.1 of the Alpharma agreement, as interpreted by the Commission in the contested decision. |
| 671 | Res je tudi, da sta navedeni sklep in sporazum Alpharma povezana. Ta sklep je bil namreč sprejet zaradi prekinitve postopka zaradi kršitev zoper podjetje Alpharma, in to prav zaradi sklenitve navedenega sporazuma. | 671 | It is also true that there is a connection between that order and the Alpharma agreement. That order was adopted in order to stay the infringement proceedings against Alpharma precisely because the Alpharma agreement had been concluded. |
| 672 | Vendar ti dejavniki ne zadostujejo za tako razlago člena 1.1 sporazuma Alpharma, ki bi se ujemala z obsegom sklepa s soglasjem podjetja Alpharma. | 672 | Nevertheless, those factors are not sufficient to interpret Article 1.1 of the Alpharma agreement as coinciding with the scope of the Alpharma consent order. |
| 673 | Kot je namreč Komisija ugotovila v točki 1054 obrazložitve izpodbijanega sklepa, gre za dva ločena pravna akta. Pomembno je to, da bi morale za to, da bi sporazum Alpharma lahko bil razlog za obstoj sklepa s soglasjem z dne 2. maja 2002, obveznosti, v katere je podjetje Alpharma privolilo v sporazumu Alpharma, zadostovati za to, da družba Lundbeck med njegovim trajanjem ne bi imela več interesa za nadaljevanje postopka zoper podjetje Alpharma, ki je bil omejen na vprašanje, ali je podjetje Alpharma že kršilo nove patente družbe Lundbeck. Ta pogoj pa je izpolnjen, tudi če področje uporabe sporazuma Alpharma presega področje uporabe navedenega sklepa. | 673 | As the Commission noted in recital 1054 of the contested decision, the two are separate legal instruments. What matters in order for it to be possible for the Alpharma agreement to have constituted the reason for the Alpharma consent order is that the obligations agreed upon by Alpharma under the Alpharma agreement, should be sufficient that, throughout the term of that agreement, Lundbeck had no further interest in pursuing the infringement proceedings against Alpharma, which were limited to the question whether Alpharma was already infringing Lundbeck’s new patents. That condition is fulfilled, even if the scope of the Alpharma agreement exceeds that of that order. |
| 674 | Sicer pa je povsem razumljivo, ker nacionalnemu sodišču, ki je sprejelo sklep s soglasjem podjetja Alpharma, ni bilo treba razkriti natančnega področja uporabe sporazuma Alpharma, da sta stranki tega sporazuma v besedilu sklepa, ki sta mu ga predložili, povzeli samo tiste obveznosti iz navedenega sporazuma, ki so bile upoštevne za postopek zaradi kršitev zoper podjetje Alpharma. Poleg tega odsotnost neposrednega ujemanja sporazuma Alpharma in navedenega sklepa potrjuje tudi to, da v tem sklepu ni nikjer omenjeno, da je navedeni sporazum določal obrnjeno plačilo v korist podjetja Alpharma, čeprav je bil to temeljni dejavnik v zvezi z njegovo sklenitvijo. | 674 | Moreover, since it was not necessary to disclose before the national court which adopted the Alpharma consent order the precise scope of the Alpharma agreement, it is entirely reasonable that the parties to that agreement merely restated, in the text of the order submitted to that court, the obligations arising from that agreement which were relevant for the purposes of the infringement proceedings against Alpharma. Furthermore, the lack of a direct correspondence between the Alpharma agreement and that order is confirmed by the fact that that order makes no reference to the fact that that agreement provided for a reverse payment to Alpharma, even though that was a fundamental element with regard to its conclusion. |
| 675 | Iz navedenega sledi, da sklep s soglasjem podjetja Alpharma ne omogoča razlage člena 1.1 sporazuma Alpharma v smislu, kot predlagata tožeči stranki. | 675 | It follows that the Alpharma consent order does not allow Article 1.1 of the Alpharma agreement to be interpreted in the sense suggested by the applicants. |
| 676 | Tožeči stranki se na petem mestu sklicujeta na elektronsko sporočilo enega od njunih zaposlenih, vpletenega v zadevo, z dne 12. marca 2002 (v nadaljevanju: elektronsko sporočilo z dne 12. marca 2002), ki je navedel, da je kljub številnim negotovostim menil, da podjetje Alpharma v predvidljivi prihodnosti ne bo vstopilo na trg Združenega kraljestva. Po mnenju tožečih strank naj ne bi bilo nobene negotovosti, če bi imel člen 1.1 tako področje uporabe, kot mu ga pripisuje Komisija. | 676 | In the fifth place, the applicants refer to the email of 12 March 2002 from one of their executives involved in the file (‘the email of 12 March 2002’), which asserted that, although there was considerable uncertainty, he did not believe that Alpharma would enter the United Kingdom market in the foreseeable future. The applicants submit that there would have been no uncertainty if Article 1.1 of that agreement had the scope that the Commission attributed to it. |
| 677 | V zvezi s tem je treba ugotoviti, da je navedeno elektronsko sporočilo odgovor na drugo elektronsko sporočilo, v katerem je bil cenik podjetja Alpharma v zvezi s citalopramom in prošnja naslovniku elektronskega sporočila, da preveri, kako je s tem pri njem. Komisija meni, da je avtor elektronskega sporočila z dne 12. marca 2002 v odgovor na to prošnjo navedel, da gre verjetno za star cenik in pojasnil, da glede tega ni bil v stiku s podjetjem Alpharma, zato na podlagi ničesar v tem elektronskem sporočilu ni mogoče ovreči razlage področja uporabe sporazuma Alpharma v izpodbijanem sklepu. | 677 | It must be noted, in that regard, that that email is a reply to another email containing a price list from Alpharma relating to citalopram and asking the recipient of that email to check the situation with Alpharma. According to the Commission, since, in his reply to that request, the author of the email of 12 March 2002 indicates that it is probably an old price list and specifies that he has not contacted Alpharma on that matter, there is nothing in that email which can call into question the interpretation of the scope of the Alpharma agreement contained in the contested decision. |
| 678 | Če bi bilo namreč – kot navajata tožeči stranki – področje uporabe sporazuma Alpharma omejeno na citalopram, proizveden po postopku Cipla I, ki ga je podjetje Alpharma že prejelo ali naročilo, bi ju moral ta cenik skrbeti, tako da je avtor elektronskega sporočila z dne 12. marca 2002 verjetno ugotavljal, ali je podjetje Alpharma že morda pridobilo citalopram, proizveden po drugih postopkih, ki niso bili zajeti z obveznostmi na podlagi tako razlaganega sporazuma Alpharma. Zato dejstvo, da avtor navedenega elektronskega sporočila ni ukrepal po prejemu prošnje svojega sodelavca, pri tem pa menil, da podjetje Alpharma v predvidljivi prihodnosti ne bo vstopilo na trg, navaja k sklepu, da je menil, da se sporazum Alpharma nanaša samo na citalopram, proizveden po postopku Cipla I. | 678 | If the scope of the Alpharma agreement was limited to citalopram produced in accordance with the Cipla I process, which Alpharma had already received or ordered, as the applicants claim, they ought to have been concerned about that price list, so that the author of the email of 12 March 2002 would have probably taken steps to determine whether Alpharma had already been able to obtain citalopram produced in accordance with other processes which were not covered by the obligations arising from the Alpharma agreement interpreted in that manner. Therefore, the fact that the author of that email did not follow up on the request he received from his colleague while stating that he did not think that Alpharma would enter the market in the foreseeable future implies that he considered that the Alpharma agreement did not concern only citalopram produced in accordance with the Cipla I process. |
| 679 | Ker pa gre zgolj za hipoteze, je treba ugotoviti, da elektronsko sporočilo z dne 12. marca 2002 ne omogoča zanesljivega sklepanja o področju uporabe sporazuma Alpharma. V zvezi s tem je treba ugotoviti, da se Komisija v podporo svoji razlagi sporazuma Alpharma ni oprla na to elektronsko sporočilo, ampak ga je v izpodbijanem sklepu samo omenila pri zavrnitvi trditve tožečih strank v podporo njuni razlagi navedenega sporazuma. | 679 | However, since these are mere hypotheses, it must be noted that the email of 12 March 2002 does not allow firm conclusions to be drawn as to the scope of the Alpharma agreement. In that regard, it must be noted that the Commission did not rely on that email to support its interpretation of the Alpharma agreement, but merely referred to it in the contested decision in order to reject one of the applicants’ arguments in support of their interpretation of that agreement. |
| 680 | Na podlagi navedenih preudarkov je treba razsoditi, da je Komisija pravno zadostno dokazala, da je mogoče na podlagi jezikovne, kontekstualne in teleološke razlage sporazuma Alpharma skleniti, da obveznosti podjetja Alpharma v skladu s členom 1.1 navedenega sporazuma niso bile omejene na citalopram, proizveden po postopkih, v zvezi s katerimi sta podjetje Alpharma in družba Lundbeck soglašala, da kršijo nove patente zadnjenavedene. Te obveznosti se namreč niso nanašale samo na citalopram, ki ga je podjetje Alpharma že imelo na zalogi in je bil proizveden po postopku Cipla I, pač pa tudi na citalopram, ki ga je ali bo naročilo pri družbi Tiefenbacher, ne glede na postopek, ki ga je uporabil proizvajalec AFU, ki jo je dobavil družbi Tiefenbacher. | 680 | In the light of all the foregoing considerations, it must be held that the Commission has proved to a sufficient legal standard that a literal, contextual and teleological interpretation of the Alpharma agreement allowed the conclusion that the obligations assumed by Alpharma by virtue of Article 1.1 of that agreement were not limited to citalopram produced in accordance with processes which Alpharma and Lundbeck had acknowledged that they were infringing Lundbeck’s new patents. Those obligations concerned not only the citalopram that Alpharma already had in stock, produced in accordance with the Cipla I process, but also citalopram that it had ordered or would order from Tiefenbacher, irrespective of the process used by the API producer which supplied Tiefenbacher. |
| 681 | Na podlagi take razlage člena 1.1 sporazuma Alpharma je mogoče ugotoviti, da so obveznosti podjetja Alpharma presegale tiste, ki bi jih družba Lundbeck lahko dosegla z uveljavljanjem svojih novih patentov. | 681 | That interpretation of Article 1.1 of the Alpharma agreement allows the conclusion that the obligations undertaken in that agreement by Alpharma exceeded those that Lundbeck could have obtained through enforcement of its new patents. |
| 682 | Ker tožeči stranki nista uspeli ovreči dokazov, na podlagi katerih je Komisija dokazala, da je sporazum Alpharma vseboval omejitve za to podjetje, ki so presegale tiste, ki bi jih lahko dosegli z uveljavljanjem njunih novih patentov in z uspešnostjo v sodnih postopkih v zvezi s tem, je treba obravnavani del zavrniti. | 682 | Since the applicants have not succeeded in rebutting the evidence by which the Commission proved that the Alpharma agreement included restrictions for that undertaking which went beyond those that they could have obtained by relying on their new patents and obtaining damages in the event of litigation in that regard, the present part must be rejected. |
| 6. Sporazum Ranbaxy | 6. The Ranbaxy agreement |
| 683 | Tožeči stranki trdita, da je Komisija storila očitno napako pri presoji s stališčem, da je sporazum Ranbaxy temu podjetju omejeval ne samo prodajo citaloprama, proizvedenega po postopku, ki ga je že uporabljala, ampak tudi tistega, proizvedenega po postopkih, ki bi jih morda razvilo med trajanjem tega sporazuma. | 683 | The applicants claim that the Commission made a manifest error of assessment in concluding that the Ranbaxy agreement prohibited that undertaking from selling not only citalopram produced in accordance with the process already in use, but also citalopram produced in accordance with the processes that it might develop during the term of that agreement. |
| 684 | Komisija to razlago zavrača. | 684 | The Commission disputes that interpretation. |
| 685 | Tožeči stranki v zvezi s tem na prvem mestu trdita, da se člen 1.1 sporazuma Ranbaxy (glej točko 48, prva alineja, zgoraj) pri tem, ko omenja „kakršno koli proizvodno metodo, ki jo uporablja podjetje Ranbaxy“, ne nanaša na metode, ki bi jih zadnjenavedeno lahko razvilo po sklenitvi sporazuma Ranbaxy in s katerimi morda njuni patenti ne bi bili kršeni, kar naj sicer ne bi bilo možno. Menita, da razlaga Komisije ni združljiva z uvodnimi izjavami preambule sporazuma Ranbaxy in okoliščinami sklenitve tega sporazuma. | 685 | In the first place, the applicants maintain, in that regard, that Article 1.1 of the Ranbaxy agreement (see the first indent of paragraph 48 above), where it mentions ‘any production method used by [Ranbaxy]’, does not refer to the methods that Ranbaxy might be able to develop after the conclusion of the Ranbaxy agreement and which could not infringe their patents, a possibility which, moreover, did not exist. The applicants submit that the Commission’s interpretation is incompatible with the recitals in the Ranbaxy preamble and with the circumstances in which that agreement was concluded. |
| 686 | Opozoriti je treba na to, da so obveznosti podjetja Ranbaxy po sporazumu Ranbaxy navedene v členu 1.1 tega sporazuma, ki se glasi: | „Družba Ranbaxy Laboratories pod pogoji [tega sporazuma] in pod pogojem plačila družbe Lundbeck ne bo uveljavljala nobene pravice iz [p]rijave [p]atenta [iz preambule] ali iz kakršne koli proizvodne metode družbe Ranbaxy Laboratories ter bo prenehala, ustavila in opustila proizvodnjo ali prodajo farmacevtskih proizvodov na tej podlagi [zlasti v EGP] med trajanjem sporazuma […].“ | 686 | It must be recalled that the obligations undertaken by Ranbaxy by virtue of the Ranbaxy agreement are those set out in Article 1.1 of that agreement, which provides as follows: | ‘Subject to the terms and conditions of this Agreement and subject to payment of the Settlement Amount by Lundbeck, [Ranbaxy Laboratories] shall not … claim any rights on the [p]atent [a]pplication [referred to in the preamble] or any production method used by [Ranbaxy Laboratories] and shall cancel, cease and desist from any manufacture or sale of pharmaceutical products based hereon [in particular in the EEA] during the term of this Agreement …’. |
| 687 | Ugotoviti je treba, da je Komisija zlasti v točkah od 1131 do 1137 ugotovila, da besedilo „kakršna koli proizvodna metoda družbe Ranbaxy Laboratories“ ne zajema samo postopek, ki ga je podjetje Ranbaxy že uporabljalo do sklenitve sporazuma Ranbaxy, ampak tudi tiste, ki bi jih lahko razvilo pozneje med trajanjem tega sporazuma. | 687 | It must be observed that the Commission took the view, inter alia in recitals 1131 to 1137 of the contested decision, that the expression ‘any production method used by Ranbaxy’ covered not only the process already used by Ranbaxy at the time of conclusion of the Ranbaxy agreement, but also those that it might develop subsequently, during the term of that agreement. |
| 688 | Tožeči stranki to razlago izpodbijata in trdita, da navedeno besedilo zajema samo postopke podjetja Ranbaxy ob sklenitvi sporazuma Ranbaxy. | 688 | The applicants dispute that interpretation and claim that that expression covers only processes which Ranbaxy already had when the Ranbaxy agreement was concluded. |
| 689 | V zvezi z besedilom navedenega člena je treba ugotoviti, da je mogoče že samo na podlagi uporabe besedne zveze „kakršna koli […] metoda“ sklepati, da ni šlo samo za metode, ki jih je podjetje Ranbaxy uporabljalo ob podpisu tega sporazuma, in da so bile mišljene tudi metode, ki bi jih lahko razvilo pozneje, kot je Komisija ugotovila v izpodbijanem sklepu. | 689 | As regards the wording of that article, it must be noted that the use of the expression ‘any ... method’ permits, in itself, the view that it did not concern only the methods already used by Ranbaxy when it signed that agreement and that the methods that it might develop subsequently were also covered, as the Commission noted in the contested decision. |
| 690 | Kljub temu pa je treba preveriti, ali drugi elementi iz sporazuma Ranbaxy ali okoliščine njegove sklenitve izpodbijajo navedeno razlago. | 690 | It is necessary, however, to confirm whether other factors arising from the Ranbaxy agreement itself or from the context in which it was concluded undermine that interpretation. |
| 691 | V zvezi s tem tožeči stranki, prvič, opozarjata na to, da je v peti in šesti uvodni izjavi preambule sporazuma Ranbaxy omenjene prijave patentov podjetja Ranbaxy v Indiji (tretja uvodna izjava), ki so se po njunem mnenju na podlagi rezultatov laboratorijskih analiz nanašale na postopke, s katerimi so bili kršeni njuni patenti za amid in jod. | 691 | In that regard, first, the applicants submit that the fifth and sixth recitals in the Ranbaxy preamble refer to the patent applications filed by Ranbaxy in India (third recital) which, from their point of view, based on the results of laboratory analyses, related to processes which infringed its amide and iodo patents. |
| 692 | Vendar gre pri tem za dejavnike, ki pojasnjujejo okoliščine sklenitve sporazuma Ranbaxy, ne zadostujejo pa za ovrženje dejstva, da člen 1.1 sporazuma Ranbaxy glede na svoje jasno besedilo ne vsebuje omejitev v zvezi s postopki, na katere so se nanašale obveznosti podjetja Ranbaxy. Če pa bi stranki tega sporazuma želeli omejiti obseg teh obveznosti na postopke, ki ustrezajo prijavam patentov podjetja Ranbaxy, bi se odločili za ustrezno prilagojeno besedilo, namesto da sta se odločili za zelo široko besedilo, katerega obseg pa bi bilo treba zožiti s sistematsko razlago v skladu s preambulo. | 692 | However, those are factors which explain the context in which the Ranbaxy agreement took place but do not suffice to call into question the fact that, in the light of its clear wording, Article 1.1 of the Ranbaxy agreement does not contain restrictions concerning the processes covered by the obligations undertaken by Ranbaxy. If the parties to that agreement had intended to restrict the scope of those obligations to the processes corresponding to Ranbaxy’s patent applications, they could have chosen suitable wording for that purpose, instead of choosing very broad wording, whose scope has to be restricted by a constructive interpretation in the light of the preamble to that agreement. |
| 693 | Drugič, okoliščine sklenitve sporazuma Ranbaxy potrjujejo razlago člena 1.1 v točki 689 zgoraj. Kot je namreč Komisija v bistvu ugotovila zlasti v točkah od 130 do 132, 140, 204 in 206 obrazložitve izpodbijanega sklepa, je družba Lundbeck želela odložiti vstop generičnega citaloprama na trg, da bi ustvarila najboljše možne razmere za dajanje na trg svojega novega zdravila, Cipralexa, ki je bil varovan s patentom (glej točko 22 zgoraj). | 693 | Secondly, the context in which the Ranbaxy agreement was concluded confirms the interpretation of Article 1.1 of that agreement set out in paragraph 689 above. As the Commission noted in essence, inter alia in recitals 130 to 132, 140, 204 and 206 of the contested decision, Lundbeck wished to delay the entry of generic citalopram on the market, in order to create the best possible conditions for the launch of its new medicinal product Cipralex, which was protected by a patent (see paragraph 22 above). |
| 694 | Ob upoštevanju tega cilja ni predstavljivo, da bi tožeči stranki privolili v plačilo zneskov iz sporazuma Ranbaxy podjetju Ranbaxy, če bi mu ta sporazum dovoljeval proizvodnjo in prodajo generičnega citaloprama po drugih postopkih, kot so tisti iz njegovih prijav patentov v Indiji. Dejansko je malo verjetno, da bi družba Lundbeck sklenila drag sporazum, če se z njim ne bi zagotovilo, da bo podjetje Ranbaxy s svojim generičnim citalopramom ostalo zunaj trga med trajanjem tega sporazuma, med katerim pa je družba Lundbeck nameravala začeti s trženjem Cipralexa. | 694 | In the light of that objective, it is inconceivable that the applicants agreed to pay Ranbaxy the amounts provided for in the Ranbaxy agreement, if that agreement had allowed it to produce and sell generic citalopram using processes other than those covered by its patent applications filed in India. In reality, it is unlikely that Lundbeck would have concluded a costly agreement if it had not brought certainty that Ranbaxy would keep out of the market with its generic citalopram during the term of that agreement, during which Lundbeck planned to begin to market Cipralex. |
| 695 | Čeprav je res, da podjetje Ranbaxy ni imelo enakega cilja kot tožeči stranki v zvezi s Cipralexom, pa ni mogoče, da zanj ne bi vedelo, predvsem ker je imelo jasen interes prejeti določeno plačilo namesto tveganja, ki bi ga prinesel njegov vstop na trg. | 695 | While it is true that Ranbaxy did not have the same objective as the applicants as regards Cipralex, it nevertheless could not have failed to have been aware of it, in particular, since it had a clear interest in obtaining specific sums rather than taking the risks that its market entry would have entailed. |
| 696 | Na podlagi navedenih preudarkov je mogoče zavrniti tudi trditev tožečih strank, da bi morala Komisija na podlagi švedskega prava, ki ureja sporazum Ranbaxy, upoštevati tudi skupno voljo strank tega sporazuma. | 696 | Based on those considerations, the Court can also reject the applicants’ argument that, under Swedish law, which governs the Ranbaxy agreement, the Commission should have taken further into account the common intention of the parties to that agreement. |
| 697 | Iz navedenega sledi, da Komisija ni storila napake s tem, da je zlasti v točkah 1137 in 1172 obrazložitve izpodbijanega sklepa ugotovila, da obveznosti podjetja Ranbaxy po členu 1.1 sporazuma Ranbaxy ob upoštevanju njihovega okvira niso bile omejene na citalopram, proizveden po postopkih, ki jih je to podjetje uporabljalo v času podpisa tega sporazuma, zato so te obveznosti presegale obseg patentov družbe Lundbeck. | 697 | It follows from the foregoing that the Commission did not err in concluding, inter alia in recitals 1137 and 1172 of the contested decision, that the obligations undertaken by Ranbaxy under Article 1.1 of the Ranbaxy agreement, read also in the light of their context, were not limited to citalopram produced in accordance with the processes that it was using at the time of signature of that agreement, with the result that those obligations went beyond the scope of Lundbeck’s patents. |
| 698 | Tožeči stranki na drugem mestu trdita, da razlaga Komisije ni združljiva z njenim priznanjem, da je podjetje Ranbaxy lahko še naprej prodajalo citalopram, s katerim so bili kršeni njuni patenti, če je AFU za njegovo proizvodnjo izvirala od tretjih oseb. | 698 | In the second place, the applicants submit that the Commission’s interpretation cannot be reconciled with its acceptance of the fact that Ranbaxy remained free to sell citalopram infringing their patents, provided that the API came from a third party. |
| 699 | V zvezi s tem – kot utemeljeno ugotavlja Komisija – ni upoštevno, da je to v točki 694 obrazložitve izpodbijanega sklepa priznalo, da sporazum Ranbaxy temu podjetju ni preprečeval prodaje farmacevtskih proizvodov z vsebnostjo citaloprama, s katerim so se kršili patenti družbe Lundbeck, če je AFU izvirala od tretjih oseb. Obveznosti podjetja Ranbaxy, po razlagi člena 1.1 sporazuma Ranbaxy, kot jo je sprejela Komisija, v zvezi s prodajo citaloprama, ki ga je to podjetje samo proizvajalo, namreč niso povezane s povsem teoretično možnostjo, da bi podjetje Ranbaxy prodajalo proizvode z vsebnostjo citaloprama od drugih proizvajalcev AFU. V zvezi s tem je treba ugotoviti, da je bilo podjetje Ranbaxy v bistvu proizvajalec AFU in zato ni bilo zainteresirano za kupovanje AFU od drugih proizvajalcev za uporabo pri proizvodnji tablet citaloprama v obliki končnega proizvoda. | 699 | In that regard, as the Commission rightly points out, it is irrelevant that the Commission acknowledged in recital 694 of the contested decision that the Ranbaxy agreement did not prevent that company from selling pharmaceutical products containing citalopram, provided that the API came from a third party. The obligations undertaken by Ranbaxy in accordance with the Commission’s interpretation of Article 1.1 of the Ranbaxy agreement, which concern the sale of citalopram produced by that undertaking itself, are not linked to the purely theoretical possibility that Ranbaxy might sell products containing citalopram from other API producers. In that regard, it must be noted that Ranbaxy was essentially an API producer and accordingly had no interest in obtaining the API from elsewhere in order to produce citalopram in the form of finished products. |
| 700 | Na tretjem mestu, tožeči stranki trdita, da člen 1.4 sporazuma Ranbaxy (glej točko 48, zadnja alineja, zgoraj) temu podjetju ni preprečeval izpodbijanja veljavnosti njunih patentov. Tožba za ugotovitev neveljavnosti patenta naj se ne bi vlagala „na podlagi“ patenta, v navedenem členu pa je bila zaveza, da se ne bodo vložile tožbe „na podlagi“ patentov, navedenih v sporazumu Ranbaxy. Podjetju Ranbaxy naj bi bilo zgolj prepovedano vložiti tožbo zoper tožeči stranki zaradi kršitve patentov, ki jih je prijavilo v Indiji. | 700 | In the third place, the applicants maintain that Article 1.4 of the Ranbaxy agreement (see the last indent of paragraph 48 above) did not prevent Ranbaxy from challenging the validity of their patents. A legal action to have a patent declared invalid is not ‘based’ on the patent, whereas that article refers to the commitment not to initiate proceedings ‘based’ on the patents set out in the Ranbaxy agreement. All that Ranbaxy was prevented from doing was initiating proceedings against the applicants for infringement of the patents for which it had applied in India. |
| 701 | V zvezi s tem je treba najprej ugotoviti, da so te trditve brezpredmetne, ker opredelitev spornih sporazumov kot omejitev zaradi cilja, kakor izhaja iz točk 398 in 399 zgoraj, ne temelji na tem, da so v teh sporazumih določbe o neizpodbijanju. Poleg tega iz točke 1174 obrazložitve izpodbijanega sklepa jasno izhaja, da Komisija obstoja take določbe v sporazumu Ranbaxy ni omenila med upoštevnimi dejavniki za obstoj kršitve zaradi cilja. | 701 | In that regard, it must be observed, first of all, that those arguments are ineffective because, as is clear from paragraphs 398 and 399 above, the classification of the agreements at issue as restrictions by object does not rely on the presence in the agreement of no-challenge clauses. Moreover, it is clear from recital 1174 that the presence of such a clause in the Ranbaxy agreement was not referred to by the Commission as one of the relevant factors in concluding that there was infringement by object. |
| 702 | Vsekakor je treba ugotoviti, da je besedilo „se zavezuje, da ne bo vložila tožb […] na podlagi katerega koli zgoraj navedenega patenta“ iz člena 1.4 sporazuma Ranbaxy dovolj prožno, da lahko zajema tožbe za izpodbijanje veljavnosti zadevnih patentov. Sicer pa je treba ugotoviti, da podjetje Ranbaxy med trajanjem sporazuma Ranbaxy ni izpodbijalo veljavnosti teh patentov. | 702 | In any event, it must be noted that the expression ‘undertake not to initiate legal proceedings ... based on any of the patents set out above’ contained in Article 1.4 of the Ranbaxy agreement is sufficiently flexible to include actions seeking to challenge the validity of the patents in question. Furthermore, it must be noted that Ranbaxy did not contest the validity of those patents during the term of the Ranbaxy agreement. |
| 703 | Na četrtem mestu, tožeči stranki trdita, da je bil očitek v zvezi s členom 1.4 sporazuma Ranbaxy naveden zgolj v dopisu o dejstvih in ne že v obvestilu o ugotovitvah o možnih kršitvah, s čimer naj bi bila kršena pravica do obrambe. | 703 | In the fourth place, the applicants claim that the complaint relating to Article 1.4 of the Ranbaxy agreement was raised only in the letter of facts, and not in the statement of objections, which constituted a breach of the applicants’ rights of defence. |
| 704 | V zvezi s tem zadostuje ugotovitev, da tožeči stranki priznavata, da je bila navedena določba in razlaga, ki jo je v zvezi z njo v izpodbijanem sklepu sprejela Komisija, v dopisu o dejstvih, na katerega sta odgovorili, tudi glede tega. Iz tega sledi, da sta imeli možnost izjave o tem in zato njuna pravica do obrambe ni bila kršena (glej v tem smislu sodbo z dne 20. marca 2002, LR AF 1998/Komisija, T‑23/99, Recueil, EU:T:2002:75, točka 190 in navedena sodna praksa). | 704 | It is sufficient to note, in that regard, that the applicants acknowledge that that clause and the Commission’s interpretation thereof in the contested decision appeared in the letter of facts, to which they replied, including in respect of that point. It follows that they had the opportunity to express their views in that regard, with the result that their rights of defence were not infringed (see, to that effect, judgment of 20 March 2002 in LR AF 1998 v Commission, T‑23/99, ECR, EU:T:2002:75, paragraph 190 and the case-law cited). |
| 705 | Zato je treba tako obravnavani del kot tudi celoten šesti tožbeni razlog zavrniti. | 705 | The present part must therefore be rejected, as must the sixth plea in law in its entirety. |
| III – Sedmi tožbeni razlog: očitna napaka pri presoji, ker povečana učinkovitost na podlagi spornih sporazumov ni bilo pravilno ovrednotena | III – The seventh plea in law, alleging a manifest error of assessment in that the efficiency gains of the agreements at issue were not properly evaluated |
| 706 | Tožeči stranki opozarjata, da sta v odgovoru na obvestilo o ugotovitvah o možnih kršitvah navedli, da sporni sporazumi koristijo konkurenci, ker se je s poravnavami na eni strani ohranila motivacija za inovacije, na drugi strani pa olajšujejo generikom hitrejši vstop na trg. Komisija naj teh utemeljitev ne bi ustrezno obravnavala. Poleg tega naj ex post pojasnila Komisije v njenem odgovoru na tožbo ne bi bila dopustna. | 706 | The applicants observe that they claimed, in their reply to the statement of objections, that the agreements at issue favoured competition, since settlement agreements preserve the incentive to innovate and can facilitate earlier market entry. The Commission failed to examine those arguments to the requisite standard. In addition, the Commission’s ex post explanations in its defence are inadmissible. |
| 707 | Komisija te trditve zavrača. | 707 | The Commission disputes those arguments. |
| 708 | Ugotoviti je treba, da je Komisija morebitno uporabljivost člena 101(3) PDEU za sporne sporazume obravnavala v točki 1212 in naslednjih obrazložitve izpodbijanega sklepa. | 708 | It must be noted that the Commission examined the possible application of Article 101(3) TFEU to the agreements at issue in recital 1212 et seq. of the contested decision. |
| 709 | Tako je utemeljeno opozorila, da navedena določba podjetjem omogoča, da se zoper ugotovitev kršitve člena 101(1) zagovarjajo tako, da dokažejo izpolnjenost štirih pogojev: | — | prvič, sporazum mora prispevati k izboljšanju proizvodnje ali distribucije proizvodov ali k spodbujanju tehničnega ali gospodarskega napredka; | — | drugič, sporazum ne sme udeleženim podjetjem postavljati omejitev, ki niso nujne za doseganje teh ciljev; | — | tretjič, potrošnikom mora zagotavljati pravičen delež doseženih koristi; | — | četrtič, podjetjem ne sme dopuščati odprave konkurence ali njenega bistvenega dela v zvezi z zadevnimi proizvodi. | 709 | The Commission therefore rightly observed that Article 101(3) TFEU allowed undertakings to defend themselves against a finding of an infringement of Article 101(1) TFEU by demonstrating that four conditions were met: | — | first, the agreement in question must contribute to improving production or distribution or to promoting technical or economic progress; | — | secondly, the agreement in question must not impose restrictions which are not indispensable to the attainment of those objectives; | — | thirdly, it must give consumers a fair share of the benefits obtained; | — | fourthly, it must not allow undertakings to eliminate all competition or a substantial part of that competition in respect of the products in question. |
| 710 | V skladu s členom 2 Uredbe št. 1/2003 in sodno prakso (sodba z dne 6. oktobra 2009, GlaxoSmithKline Services in drugi/Komisija in drugi, C‑501/06 P, C‑513/06 P, C‑515/06 P in C‑519/06 P, ZOdl., EU:C:2009:610, točka 82) mora stranka, ki se sklicuje na člen 101(3) PDEU, s prepričljivimi trditvami in dokazi dokazati, da so izpolnjeni pogoji za upravičenost do izvzetja. | 710 | Article 2 of Regulation No 1/2003 provides, as does the case-law (see, to that effect, judgment of 6 October 2009 in GlaxoSmithKline Services and Others v Commission, C‑501/06 P, C‑513/06 P, C‑515/06 P and C‑519/06 P, ECR, EU:C:2009:610, paragraph 82), that it is for the party relying on the application of Article 101(3) TFEU to demonstrate, by means of convincing arguments and evidence, that the conditions for obtaining an exemption are satisfied. |
| 711 | Dokazno breme ima torej podjetje, ki prosi za izvzetje na podlagi člena 101(3) PDEU. Vendar lahko dejstva, na katere se sklicuje navedeno podjetje, drugo stranko zavežejo k pojasnilu ali upravičevanju, ker je sicer dopusten sklep, da je bilo zahtevam v zvezi z dokaznim bremenom zadoščeno (glej zgoraj v točki 710 navedeno sodbo GlaxoSmithKline Services in drugi/Komisija in drugi, točka 83 in navedena sodna praksa). | 711 | The burden of proof thus falls on the undertaking requesting an exemption under Article 101(3) TFEU. However, the facts relied on by that undertaking may be such as to oblige the other party to provide an explanation or justification, failing which it is permissible to conclude that the burden of proof has been discharged (see, to that effect, judgment in GlaxoSmithKline Services v Commission, cited in paragraph 710 above, paragraph 83 and the case-law cited). |
| 712 | Komisija je v nasprotju z zatrjevanjem tožečih strank v izpodbijanem sklepu ustrezno obravnavala različne trditve generičnih podjetij in tožečih strank med upravnim postopkom. | 712 | Contrary to the applicant’s claim, the Commission examined to the requisite standard, in the contested decision, the various arguments relied upon by the generic undertakings and by the applicants during the administrative procedure. |
| 713 | Prvič, v zvezi s trditvijo, da sporni sporazumi tožeči stranki spodbujajo k inovacijam, je treba tako kot Komisija ugotoviti – čeprav ta te trditve resda ni posebej obravnavala v delu sklepa v zvezi z uporabljivostjo člena 101(3) PDEU – da sta tožeči stranki v svojem odgovoru na obvestilo o ugotovitvah o možnih kršitvah zgolj splošno navedli, da se s poravnavami ohranja spodbuda k inovacijam, in se pri tem opirali na določeno ekonomsko raziskavo, nista pa pojasnili, kako naj bi sporni sporazumi ustvarili tako spodbudo v obravnavani zadevi, poleg zakonodajnega varstva na podlagi patentov, ali kako so bili v obravnavani zadevi izpolnjeni štirje pogoji za uporabo člena 101(3) PDEU. Z raziskavo, ki sta jo predložili tožeči stranki, se bolj dvomi v uporabljivost člena 101(1) PDEU, ker se v njej zavrača, da bi patentne poravnave, kot so sporni sporazumi, lahko negativno vplivale na potrošnike. Zato Komisiji te trditve, ker jo je zavrnila že pri presoji obstoja omejitve zaradi cilja (točke od 710 do 713 obrazložitve izpodbijanega sklepa), brez podrobnejših utemeljitev v zvezi s tem ni bilo treba ponovno obravnavati z vidika člena 101(3) PDEU. | 713 | First, as regards the argument that the agreements at issue encouraged the applicants’ incentive to innovate, while it is true that such an argument was not examined specifically by the Commission in the part of the decision relating to the assessment of the applicability of Article 101(3) TFEU, it must be noted, as the Commission states, that, in their reply to the statement of objections, the applicants merely declared in a general manner that settlement agreements in respect of patents preserved the incentive to innovate, relying on an economic study, but without explaining how the agreements at issue contributed to the generation of such an incentive in the present case, beyond the regulatory protection attached to the patents, or how the four conditions for application of Article 101(3) TFEU were satisfied in the present case. The study put forward by the applicants rather called into question the applicability of Article 101(1) TFEU itself, in so far as it disputed that settlement agreements in respect of patents, such as the agreements at issue, could have negative effects on consumers. Accordingly, since that argument had already been rejected by the Commission in the assessment of a restriction by object (recitals 710 to 713 of the contested decision), it was not required to examine it again under Article 101(3) TFEU, in the absence of more substantiated arguments in that regard. |
| 714 | Vsekakor pa je v obravnavani zadevi očitno, da sporni sporazumi, s katerimi se je želelo z obrnjenimi plačili preložiti vstop generikov na trg, niso bili nepogrešljivi za ohranitev spodbude tožečih strank za inovacije. Poleg tega si je težko zamisliti koristnost takih sporazumov za potrošnike. Nazadnje, pogoj v zvezi z odsotnostjo odprave konkurence v obravnavani zadevi prav tako ni izpolnjen, ker so bila generična podjetja ob sklenitvi spornih sporazumov res potencialni konkurenti in ker so se odplačno zavezala, da ne bodo vstopila na trg med trajanjem navedenih sporazumov. | 714 | In any event, it is clear in the present case that the agreements at issue, which sought to delay the entry of generics on the market by means of reverse payments, were not essential in order to preserve the applicants’ incentive to innovate. Furthermore, it is difficult to discern the benefits that consumers would derive from such agreements. Finally, the condition that all competition should not be eliminated is also not satisfied in the present case, given that the generic undertakings were indeed potential competitors when the agreements at issue were concluded and they agreed, against payment, not to enter the market during the term of those agreements. |
| 715 | Zato je treba razsoditi, da Komisija ni storila napake, ko trditve tožečih strank v zvezi s spodbudami spornih sporazumov k inovacijam v izpodbijanem sklepu ni ponovno obravnavala z vidika člena 101(3) PDEU. | 715 | It must therefore be held that the Commission did not err in not carrying out a further examination in the contested decision of the applicants’ arguments relating to the incentive to innovate resulting from the agreements at issue, in the light of Article 101(3) TFEU. |
| 716 | Drugič, Komisija je v točkah od 1228 do 1230 obrazložitve izpodbijanega sklepa povsem utemeljeno zavrnila trditev, da so sporni sporazumi omogočali hitrejši vstop generikov na trg, ker ni bila podprta z dejstvi, saj se družba Lundbeck v spornih sporazumih ni nikjer zavezala, da bo dopustila vstop generikov na trg po poteku sporazumov, in ker so v resnici preprečevali morebiten takojšnji vstop teh podjetij na trg. | 716 | Secondly, in recitals 1228 to 1230 of the contested decision the Commission was fully entitled to reject the claim that the agreements at issue were capable of ensuring earlier entry of generics on the market, because it was not corroborated by the facts, since the agreements at issue did not provide for any commitment whatsoever on the part of Lundbeck to authorise the entry of generics on the market once those agreements had expired and in fact they prevented their potentially immediate market entry. |
| 717 | Iz dokazov v spisu in še posebej vsebine spornih sporazumov namreč izhaja, da ti niso določali nobenega natančnega datuma, na katerega bi lahko generična podjetja pred potekom patentov družbe Lundbeck vstopila na trg. Kot je Komisija ugotovila v točki 662 obrazložitve izpodbijanega sklepa, sporni sporazumi niso vsebovali nobene zaveze družbe Lundbeck, da ne bo vložila tožb zaradi kršitev v primeru vstopa generikov na trg po poteku teh sporazumov. Sporni sporazumi torej v resnici niso rešili patentnega spora ali omogočili hitrejši vstop generikov na trg, kot navajata tožeči stranki, ampak so zgolj omogočili družbi Lundbeck, da s plačilom znatnih zneskov generičnim podjetjem pridobi čas z odložitvijo vstopa generikov na trg. | 717 | It is clear from the evidence in the file and, in particular, the content of the agreements at issue, that they contained no precise date on which the generic undertakings could have entered the market before the expiry of Lundbeck’s patents. As the Commission noted in recital 662 of the contested decision, the agreements at issue did not contain any commitment on Lundbeck’s part to refrain from infringement proceedings in the event that generics entered the market after the expiry of those agreements. The agreements at issue did not therefore genuinely resolve a patent dispute or allow earlier entry of generics on the market, as the applicants claim, but merely allowed Lundbeck to gain time by delaying the entry of generics on the market against payment of significant sums to the generic undertakings. |
| 718 | Tretjič, tudi trditev, da so se s spornimi sporazumi preprečili veliki stroški postopkov ali različne sodne odločbe, ni podprta z dejstvi, ker se zaradi teh sporazumov ni končal osnovni patentni spor med strankami teh sporazumov, saj ni bilo izključeno, da bi družba Lundbeck vložila tožbe zoper generična podjetja po poteku teh sporazumov, tudi pred različnimi sodišči v različnih državah članicah EGP. Zato niso upoštevne številke, ki jih navajata tožeči stranki in izkazujejo več milijonov eurov stroškov postopkov, ki niso nastali v EGP, ker ni izkazano, da bi ti stroški brez spornih sporazumov zanesljivo nastali. Čeprav je res, da družba Lundbeck nazadnje ni vložila nobene tožbe po poteku teh sporazumov, pa je to predvsem zato, ker družba Lundbeck za to ni bila več zainteresirana, ker so takrat druga generična podjetja, kot na primer družba Lagap v Združenem kraljestvu, že vstopila na trg. | 718 | Thirdly, the claim that the agreements at issue made it possible to avoid large litigation costs or differing court rulings is also not corroborated by the facts, since those agreements did not enable the underlying patent dispute between the parties to those agreements to be resolved, given that there was nothing to prevent Lundbeck from bringing legal proceedings against the generic undertakings on their expiry, including before different courts established in different EEA Member States. Accordingly, the figures put forward by the applicant, which report several million euros of legal costs avoided for the whole of the EEA, are irrelevant, in so far as it does not appear that those costs would certainly have been incurred in the absence of the agreements at issue. While it is true that, ultimately, no proceedings were initiated by Lundbeck after the expiry of those agreements, that is principally because such proceedings were of no further interest to Lundbeck, since other generic undertakings, such as Lagap in the United Kingdom, had already entered the market at that time. |
| 719 | Vsekakor pa tožeči stranki, tudi če bi se s spornimi sporazumi preprečili nekateri stroški v zvezi s potencialnimi postopki pred različnimi sodišči, nista dokazali, zakaj so bile omejitve konkurence iz teh sporazumov nujne za uresničitev tega cilja, čeprav je bilo mogoče skleniti druge vrste poravnav, ki ne bi bile protikonkurenčne (glej točki 350 in 529 zgoraj). Prav tako nista pojasnili, kako naj bi ti sporazumi potrošnikom zagotovili pravičen delež domnevno pridobljenih koristi. | 719 | In any event, even if the agreements at issue made it possible to avoid certain costs associated with potential proceedings before different courts, the applicants have failed to establish how the restrictions on competition arising from those agreements were indispensable for the achievement of that objective, given that the conclusion of other types of settlement agreements, with no anticompetitive aspect, was possible (see paragraphs 350 and 529 above). Furthermore, they have not explained how those agreements allowed consumers a fair share of the benefits allegedly obtained. |
| 720 | Zato je treba presoditi, da Komisija ni storila napake niti ni kršila pravil v zvezi z dokaznim bremenom, ko je ugotovila, da pogoji iz člena 101(3) PDEU v obravnavani zadevi niso bili izpolnjeni. | 720 | It must be held therefore that the Commission did not err or fail to observe the rules on the burden of proof in finding that the conditions laid down in Article 101(3) TFEU were not met in the present case. |
| 721 | Zato je treba sedmi tožbeni razlog zavrniti. | 721 | The seventh plea in law must therefore be rejected. |
| IV – Osmi tožbeni razlog: kršitev pravice do obrambe | IV – The eighth plea in law, alleging breach of the rights of the defence |
| 722 | Tožeči stranki trdita, da se z izpodbijanim sklepom krši njuna pravica do obrambe, ker je Komisija spremenila sestavine zatrjevane kršitve iz obvestila o ugotovitvah o možnih kršitvah, ne da bi ju pred tem zaslišala. Ne bi naj imeli možnosti zavrniti trditev Komisije, da so bila generična podjetja kljub možni ali verjetni kršitvi njunih patentov njuni potencialni konkurenti, ter stališča Komisije, da obrnjena plačila sama po sebi zadostujejo kot dokaz, da so sporni sporazumi kršitev zaradi cilja. Komisija bi poleg tega morala tožečima strankama omogočiti dostop do njene korespondence s KFST, ker bi ta korespondenca lahko vsebovala razbremenilne dokaze. | 722 | The applicants claim that the contested decision breaches their rights of defence, since the Commission altered the constituent elements of the infringement alleged in the statement of objections without first hearing them. They were not given the opportunity to rebut the Commission’s assertions about the generic undertakings being their potential competitors in spite of the possibility or likelihood that their patents were infringed, and about the Commission’s view that the reverse payments alone sufficed to establish that the agreements at issue constituted infringements by object. The Commission should also have given the applicants access to its correspondence with the KFST, since it might have contained exculpatory evidence. |
| A – Prvi del | A – The first part |
| 723 | Tožeči stranki menita, da se je s popolnim preoblikovanjem teorije Komisije kršila njuna pravica do izjave. Opozarjata, da v skladu s sodno prakso, čeprav so vsa dejstva, na katera se je Komisija oprla v izpodbijanem sklepu, obstajala že v obvestilu o ugotovitvah o možnih kršitvah, pravica do obrambe ni bila spoštovana, ker so bila ta dejstva navedena v različnih delih obvestila o ugotovitvah o možnih kršitvah brez medsebojne povezanosti in ne da bi jih Komisija kakor koli označila. | 723 | The applicants maintain that the complete reworking of the Commission’s theory constitutes a breach of their right to be heard. They submit that, according to the case-law, even though all the factual elements on which the Commission relied in the contested decision were already in the statement of objections, the rights of the defence were not respected since those factual elements had been set out at various points in that statement of objections, without any link being established between them and without being characterised in any particular way by the Commission. |
| 724 | Tožeči stranki trdita, da se je v izpodbijanem sklepu bistveno spremenilo stališče iz obvestila o ugotovitvah o možnih kršitvah v zvezi z vprašanjem potencialne konkurence, ki je bistvena sestavina zatrjevane kršitve. Komisija naj bi tako v izpodbijanem sklepu, prvič, bistveno spremenila svoje stališče z navedbo, da bi bilo treba tudi generična podjetja, ki niso imela dostopa do neponarejenega citaloprama, obravnavati kot potencialne konkurente družbe Lundbeck, drugič, razlikovala med dvema fazama izvrševanja potencialne konkurence, in tretjič, dodala, da se potencialna konkurenca izraža tudi z izpodbijanjem veljavnosti patentov, poskusi inovacij na podlagi patentiranih postopkov ali s sodnim zahtevanjem ugotovitve neponarejenosti, in celo z vstopom „s tveganjem“, ki naj bi bil bistvo konkurence v farmacevtskem sektorju. | 724 | In the first place, the applicants claim that the contested decision substantially departed from the position expressed in the statement of objections as regards the question of potential competition, which is a key constituent element of the alleged infringement. Thus, in the contested decision, the Commission (i) substantially changed its position by stating that even the generic undertakings that did not have access to non-infringing citalopram had to be regarded as potential competitors of Lundbeck, (ii) distinguished two stages in which potential competition existed, and (iii) added that potential competition was also expressed through challenges to the validity of patents, attempts to innovate on the basis of process patents, or proceedings seeking declarations of non-infringement, and even entry ‘at risk’, which is alleged to be the essence of competition in the pharmaceutical sector. |
| 725 | Komisija te trditve zavrača. | 725 | The Commission disputes those arguments. |
| 726 | Opozoriti je treba, da je spoštovanje pravice do obrambe temeljna pravica prava Unije, določena v členu 41(2)(a) Listine Unije o temeljnih pravicah, ki jo je treba spoštovati v vseh postopkih. | 726 | It must be recalled that observance of the rights of the defence is a fundamental right of EU law, enshrined in Article 41(2)(a) of the Charter of Fundamental Rights of the European Union, which requires observance of those rights in all proceedings. |
| 727 | Spoštovanje pravice do obrambe torej zahteva, da se zadevni družbi v upravnem postopku da možnost, da primerno predstavi svoje stališče o resničnosti in upoštevnosti zatrjevanih dejstev in okoliščin ter o dokumentih, ki jih Komisija navaja v podporo svoji trditvi o obstoju kršitve konkurenčnega prava (zgoraj v točki 111 navedena sodba Aalborg Portland in drugi/Komisija, EU:C:2004:6, točka 66; glej v tem smislu tudi sodbo z dne 13. februarja 1979, Hoffmann-La Roche/Komisija, 85/76, Recueil, EU:C:1979:36, točka 9). | 727 | Respect for the rights of the defence thus requires that the undertaking concerned must have been afforded the opportunity, during the administrative procedure, to make known its views on the truth and relevance of the facts and circumstances alleged and on the documents used by the Commission to support its claim that there has been an infringement of the Treaty (see, to that effect, judgment in Aalborg Portland and Others v Commission, cited in paragraph 111 above, EU:C:2004:6, paragraph 66; see also, to that effect, judgment of 13 February 1979 in Hoffmann-La Roche v Commission, 85/76, ECR, EU:C:1979:36, paragraph 9) |
| 728 | V tem smislu člen 27(1) Uredbe št. 1/2003 določa, da Komisija na eni strani podjetjem ali podjetniškim združenjem, podrejenim postopkom, ki jih vodi Komisija, da priložnost za zaslišanje v zvezi z zadevami, proti katerim Komisija ugovarja, na drugi strani pa, da odločbe Komisije temeljijo samo na ugovorih, h katerim so zadevne stranke imele priložnost dati pojasnila. | 728 | In that connection, Article 27(1) of Regulation No 1/2003 provides (i) that the Commission is to give the undertakings or associations of undertakings which are the subject of the proceedings conducted by the Commission the opportunity to be heard on the matters to which the Commission has taken objection and (ii) that the Commission is to base its decisions only on objections on which the parties concerned have been able to comment. |
| 729 | To zahtevo je treba razlagati v skladu s sodno prakso, po kateri morajo biti iz obvestila o ugotovitvah o možnih kršitvah jasno razvidni vsi bistveni elementi, na katere se je v tej fazi postopka oprla Komisija. Vendar je to lahko navedeno kot povzetek in ni nujno, da je odločba kopija obvestila o ugotovitvah o možnih kršitvah, saj je to obvestilo pripravljalni dokument, v katerem je presoja pravnih in dejanskih elementov samo začasna (glej zgoraj v točki 111 navedeno sodbo Aalborg Portland in drugi/Komisija, EU:C:2004:6, točka 67 in navedena sodna praksa). | 729 | That requirement must be interpreted in the light of the case-law to the effect that the statement of objections must set out clearly all the essential facts on which the Commission is relying at that stage of the procedure. However, that may be done summarily and the decision is not necessarily required to be a replica of the Commission’s statement of objections, since the statement of objections is a preparatory document containing assessments of fact and of law which are purely provisional in nature (see judgment in Aalborg Portland and Others v Commission, cited in paragraph 111 above, EU:C:2004:6, paragraph 67 and the case-law cited). |
| 730 | Na prvem mestu, v zvezi s trditvijo, da je Komisija v izpodbijanem sklepu bistveno spremenila svoje stališče glede vprašanja potencialne konkurence iz obvestila o ugotovitvah o možnih kršitvah, je treba ugotoviti, prvič, da Komisija v nasprotju z zatrjevanjem tožečih strank ni menila, da je mogoče samo generična podjetja, ki so že imela dostop do neponarejenega citaloprama, obravnavati kot potencialne konkurente družbe Lundbeck. Iz točk 468 in 469 obvestila o ugotovitvah o možnih kršitvah namreč med drugim izhaja stališče Komisije, da je mogoče generična podjetja in proizvajalca originalnih zdravil obravnavati kot potencialne konkurente, ne glede na to, ali se je z generičnimi proizvodi, ki so jih ta podjetja nameravala tržiti, kršil patentiran postopek ali ne. Poleg tega iz točk 519, 550, 586, 612, 645 in 683 obvestila o ugotovitvah o možnih kršitvah izhaja, da se je Komisija pri ugotavljanju obstoja vsaj potencialne konkurence med generičnimi podjetji in družbo Lundbeck oprla na več dejavnikov, tudi na to, da so generična podjetja že izvedla precej ukrepov za pripravo na svoj vstop na trg in da so za ta namen v nekaterih primerih že pridobila potrebna DZP ali zbrala precejšnjo zalogo generičnega citaloprama. | 730 | In the first place, as regards the argument that the Commission substantially changed its position concerning the question of potential competition in the contested decision compared with the statement of objections, first, it must be held, contrary to what the applicants claim, that it did not consider that only generic undertakings which had access to non-infringing citalopram could be regarded as potential competitors of Lundbeck. It is clear from recitals 468 to 469 of the statement of objections, inter alia, that the Commission considered that the generic undertakings and the originator undertaking could be regarded as potential competitors, independently of whether or not the generic products that those undertakings intended to bring to the market could have infringed a process patent. In addition, it is clear from recitals 519, 550, 586, 612, 645, and 683 of the statement of objections that the Commission relied on a set of factors, including the fact that the generic undertakings had already made significant efforts in order to prepare for their market entry, and in some cases, had already obtained the necessary MAs or assembled a large stock of generic citalopram for that purpose, in order to conclude that there was at least potential competition between them and Lundbeck. |
| 731 | Drugič, čeprav je Komisija v izpodbijanem sklepu (točka 91 zgoraj) razlikovala med dvema fazama glede potencialne konkurence, je treba ugotoviti, da v obravnavani zadevi ni sporno, da so izvirni patenti družbe Lundbeck v času sklenitve spornih sporazumov potekli v skoraj vseh državah članicah EGP, zato so bila vsa generična podjetja v napredni fazi priprav za vstop na trg. To, da je Komisija v točki 616 obrazložitve izpodbijanega sklepa menila, da se je potencialna konkurenca morda začela že leta pred potekom patenta za AFU, ni odločilno niti upoštevno za presojo položaja v zvezi s potencialno konkurenco med tožečima strankama in generičnimi podjetji v obravnavani zadevi. Zato taka presoja a fortiori ne more vplivati na pravico do obrambe tožečih strank v zvezi s tem. | 731 | Secondly, while the Commission distinguished two stages in relation to potential competition in the pharmaceutical sector in the contested decision (paragraph 91 above), it must be noted that, in the present case, the parties agree that Lundbeck’s original patents had expired in almost all EEA countries at the time when the agreements at issue were concluded, with the result that the generic undertakings were all at an advanced stage in their preparations for entering the market. The fact that the Commission considered, in recital 616 of the contested decision that potential competition could have begun years before the expiry of the patent on the API was not decisive or even relevant in respect of the assessment of the situation relating to potential competition between the applicants and the generic undertakings in the present case. A fortiori, therefore, such an assessment could have no effect on the applicants’ rights of defence in that regard. |
| 732 | Tretjič, iz obvestila o ugotovitvah o možnih kršitvah izhaja tudi, da je bil vstop generičnih podjetij „s tveganjem“ obravnavan kot del konkurenčnega procesa med njimi in družbo Lundbeck (glej zlasti točke 29, 488, 528, 562, 594, 621 in 656 obvestila o ugotovitvah o možnih kršitvah). Čeprav je res, da izpodbijani sklep vsebuje več podrobnosti v zvezi s tem, pa je treba opozoriti na to, da ni nujno, da je sklep kopija obvestila o ugotovitvah o možnih kršitvah (točka 729 zgoraj), in da mora Komisija imeti možnost v sklepu upoštevati odgovore podjetij na obvestilo o ugotovitvah o možnih kršitvah, tudi tako, da dopolni, razvije ali preoblikuje utemeljitve v podporo očitkov, ki jih bo ohranila (glej v tem smislu sodbo z dne 10. maja 2007, SGL Carbon/Komisija, C‑328/05 P, ZOdl., EU:C:2007:277, točka 62, in sodbo z dne 15. marca 2006, BASF/Komisija, T‑15/02, ZOdl., EU:T:2006:74, točka 93 in navedena sodna praksa). | 732 | Thirdly, it is also clear from the statement of objections that the entry ‘at risk’ of the generic undertakings was regarded as part of the competitive process between those undertakings and Lundbeck (see in particular recitals 29, 488, 528, 562, 594, 621 and 656 of the statement of objections). While it is true that the contested decision contains further developments in that regard, it must be recalled that that decision is not necessarily required to be a replica of the statement of objections (paragraph 729 above) and that the Commission must be able to take into account replies by the undertakings to the statement of objections, including by supplementing, developing or reformulating the arguments in support of the objections which it maintains (see, to that effect, judgments of 10 May 2007 in SGL Carbon v Commission, C‑328/05 P, ECR, EU:C:2007:277, paragraph 62, and 15 March 2006 in BASF v Commission, T‑15/02, ECR, EU:T:2006:74, paragraph 93 and the case-law cited). |
| 733 | Četrtič, tožeči stranki napačno trdita, da je Komisija v izpodbijanem sklepu ugotovila, da možnost patentnih sporov zadostuje za ugotovitev obstoja potencialne konkurence med njima in generičnimi podjetji. Tako izpodbijani sklep kot obvestilo o ugotovitvah o možnih kršitvah se namreč opirata na več dejavnikov v zvezi s tem, tudi na to, da so generična podjetja izvedla precej ukrepov za pripravo vstopa na trg (točki 96 in 730 zgoraj). Poleg tega je v obvestilu o ugotovitvah o možnih kršitvah navedeno tudi, da so patentni spori del konkurenčnega procesa v farmacevtskemu sektorju (glej zlasti točko 27 obvestila o ugotovitvah o možnih kršitvah). | 733 | Fourthly, the applicants are wrong to claim that the Commission noted, in the contested decision, that the possibility of patent litigation is sufficient to establish the existence of potential competition between them and the generic undertakings. The contested decision, like the statement of objections, is based on a set of factors in that regard, including the fact that the generic undertakings had taken significant steps to prepare for their market entry (paragraphs 96 and 730 above). Furthermore, the statement of objections also refers to the fact that patent disputes were an inherent part of the competitive process in the pharmaceutical sector (see in particular recital 27 of the statement of objections). |
| 734 | Tožeči stranki torej napačno trdita, da je Komisija od obvestila o ugotovitvah o možnih kršitvah do izpodbijanega sklepa bistveno spremenila svoje stališče v zvezi s potencialno konkurenco. | 734 | The applicants are therefore wrong to claim that between the statement of objections and the contested decision the Commission substantially changed its position concerning potential competition. |
| 735 | Na drugem mestu, tožeči stranki menita, da v obvestilu o ugotovitvah o možnih kršitvah ni jasnega in doslednega pravnega standarda za presojo obrnjenih plačil v sporazumih o patentnih poravnavah po pravu Unije o konkurenci. | 735 | In the second place, the applicants submit that the statement of objections did not set out a clear and coherent legal standard for the review of reverse payments in patent settlement agreements under EU competition law. |
| 736 | Podobno naj v obvestilu o ugotovitvah o možnih kršitvah ne bi bilo nobene navedbe v zvezi s pragom, od katerega bi bilo treba neki znesek obravnavati kot „znaten“, omenjeno je samo to, da je bilo generičnim podjetjem „ponujeno več denarja, kot bi ga lahko zaslužila na trgu s prodajo generičnih različic citaloprama“, s čimer naj bi se jih „spodbudilo k temu, da se odpovedo konkuriranju družbi Lundbeck“ (točka 710 obvestila o ugotovitvah o možnih kršitvah). | 736 | Likewise, the applicants argue that the statement of objections provided no indication of the threshold above which an amount of money should be classified as ‘considerable’, the only reference point being that the generic undertakings were ‘offered more money than they were likely to be able to make in the market by selling generic citalopram’, which, it is claimed, led to ‘an incentive to abandon their competitive challenge to Lundbeck’ (recital 710 of the statement of objections). |
| 737 | Tožečima strankama naj bi bilo zaradi odsotnosti jasnih standardov presoje onemogočeno, da učinkovito izrazita svoje stališče, kar naj bi bila še posebej huda pravna napaka, ker se v obravnavani zadevi postavljajo zapletena in nova pravna vprašanja in ker naj iz predhodne sodne prakse ne bi bilo mogoče izluščiti nobene druge usmeritve, kot je preizkus obsega patenta, ki je bil v izpodbijanem sklepu zavrnjen. | 737 | The applicants claim that the absence of a clear review standard prevented them from putting their views forward, which is a particularly serious legal flaw, since the present case raises complex and novel legal issues and since no guidance, other than the ‘scope of the patent’ test, which is rejected by the decision, could be inferred from previous case-law. |
| 738 | V zvezi s tem je treba razsoditi, da je v nasprotju z zatrjevanjem tožečih strank v točki 480 obvestila o ugotovitvah o možnih kršitvah izrecno navedeno, da je obstoj obrnjenih plačil odločilen za pravno presojo spornih sporazumov, s povsem enakim besedilom, kot je tisto v točki 660 obrazložitve izpodbijanega sklepa. Poleg tega se izpodbijani sklep, tako kot obvestilo o ugotovitvah o možnih kršitvah, opira tudi na utemeljitev, da je obstoj obrnjenih plačil v spornih sporazumih eden od upoštevnih dejavnikov za ugotovitev obstoja omejitve zaradi cilja (glej točki 661 in 662 obrazložitve izpodbijanega sklepa). Sicer pa je v obvestilu o ugotovitvah o možnih kršitvah, tako kot v izpodbijanem sklepu, navedeno, da so zneski obrnjenih plačil problematični, ker upoštevajo dobiček ali promet, ki bi ga generična podjetja dosegla ob vstopu na trg, s čimer se je zmanjšala spodbuda generičnim podjetjem, da si še naprej prizadevajo za vstop na trg (glej zlasti točke 469, 496, 543, 588, 638, 687 obvestila o ugotovitvah o možnih kršitvah in točko 366 zgoraj). | 738 | It must be held in that regard, contrary to the applicants’ claims, that recital 480 of the statement of objections expressly states that the existence of reverse payments is decisive for the purposes of the legal assessment of the agreements at issue, in the same words as contained in recital 660 of the contested decision. Furthermore, like the statement of objections, the contested decision is also based on the argument that the existence of reverse payments in the agreements at issue is one of the relevant factors for a finding of restriction by object (see recitals 661 and 662 of the contested decision). Moreover, the statement of objections states, like the contested decision, that the reverse payment amounts were problematic in so far as they took into account the profits or turnover that the generic undertakings would have made in the event of market entry, which reduced the incentive for the generic undertakings to pursue their efforts for market entry (see, in particular, recitals 469, 496, 543, 588, 638, 687 of the statement of objections and paragraph 366 above). |
| 739 | Zato je treba zavrniti tudi drugi očitek tožečih strank. | 739 | The applicant’s second complaint must therefore also be rejected. |
| 740 | Na tretjem mestu, tožeči stranki trdita, da je tako v izpodbijanem sklepu kot dopisu o dejstvih več elementov, ki jih v obvestilu o ugotovitvah o možnih kršitvah ni, kot na primer tržni deleži družbe Lundbeck na trgu zdravil proti depresiji v EGP (točka 215 obrazložitve izpodbijanega sklepa in točka 17 dopisa o dejstvih). Metoda, ki jo je Komisija uporabila za izračun teh tržnih deležev, in natančna opredelitev trga naj ne bi bili jasni in pojasnjeni ter naj ju ne bi bilo v dopisu o dejstvih. | 740 | In the third place, the applicants maintain that the contested decision and the letter of facts contain a number of elements that did not appear in the statement of objections, such as Lundbeck’s market shares in the market for antidepressants in the EEA (recital 215 of the contested decision and paragraph 17 of the letter of facts). The method used by the Commission to calculate those market shares and the precise market definition remain obscure and unexplained, nor do they appear in the letter of facts. |
| 741 | V zvezi s tržnimi deleži tožečih strank, ki jih je Komisija opisala dopisu o dejstvih z dne 12. aprila 2013 v podporo svojemu sklepu v zvezi z izkrivljanjem konkurence zaradi spornih sporazumov, je treba najprej spomniti, da sporazum, ki bi lahko prizadel trgovino med državami članicami in ki ima protikonkurenčni cilj, po svoji naravi in neodvisno od dejanskega učinka znatno omeji konkurenco (sodba z dne 13. decembra 2012, Expedia, C‑226/11, ZOdl., EU:C:2012:795, točka 37). Komisiji torej niti v obvestilu o ugotovitvah o možnih kršitvah niti v izpodbijanem sklepu ni bilo treba podrobno dokazati obstoja znatne omejitve konkurence, ker je zadostno dokazala, da imajo sporni sporazumi protikonkurenčni cilj in lahko prizadenejo trgovino med državami članicami (glej zlasti točke 196, 197, od 209 do 213, 724 in 726 obrazložitve izpodbijanega sklepa). Vsekakor sta tožeči stranki svoja stališča lahko izrazili po prejemu dopisa o dejstvih, zato se ne moreta sklicevati na kršitev njune pravice do obrambe v zvezi s tem (glej točko 704 zgoraj). | 741 | As regards the applicants’ market shares presented by the Commission in the letter of facts of 12 April 2013 in order to support its conclusion that the agreements at issue distorted competition, it must be noted, first, that an agreement that may affect trade between Member States and that has an anticompetitive object constitutes, by its nature and independently of any concrete effect that it may have, an appreciable restriction on competition (judgment of 13 December 2012 in Expedia, C‑226/11, ECR, EU:C:2012:795, paragraph 37). The Commission was not therefore required to establish in detail, in the statement of objections or in the contested decision, the existence of an appreciable restriction on competition, since it established that the agreements at issue had an anticompetitive object and could affect trade between Member States (see inter alia recitals 196, 197, 209 to 213, 724 and 726 of the contested decision). In any event, the applicants were able to comment following the communication of the letter of facts, with the result that they may not rely on an infringement of their rights of defence in that regard (see paragraph 704 above). |
| 742 | Zato je treba prvi del v celoti zavrniti. | 742 | The first part must therefore be rejected in its entirety. |
| B – Drugi del | B – The second part |
| 743 | Tožeči stranki menita, da jima je Komisija napačno zavrnila dostop do njenega dopisovanja s KFST. Čeprav je po njunem mnenju res, da Obvestilo Komisije o pravilih za vpogled v spis Komisije v zadevah na podlagi členov 81 in 82 [ES], členov 53, 54 in 57 Sporazuma EGP in Uredbe Sveta (ES) št. 139/2004 (UL 2005 C 235, str. 7) izvzema korespondenco med Komisijo in nacionalnimi organi, pristojnimi za konkurenco, iz pravice dostopa do spisa, pa iz ustaljene sodne prakse izhaja, da se lahko stranke, če izjemne okoliščine zadeve zahtevajo, seznanijo z notranjimi dokumenti Komisije. Dovolj naj bi bilo, da dokažeta obstoj možnosti, čeprav majhne, da bi bili nerazkriti dokumenti med upravnim postopkom uporabni za njuno obrambo. Tako naj bi bilo v obravnavani zadevi, ker naj bi korespondenca s KFST vsebovala potencialno razbremenilne dokaze, ki naj bi dejansko in v nasprotju z zatrjevanjem Komisije dokazovali nedorečenost prava konkurence glede poravnav z obrnjenimi plačili na dan, ko sta tožeči stranki sklenili sporne sporazume. Vsekakor pa naj bi Komisijino poznejše razkritje teh dokumentov dokazovalo, da ne vsebujejo nobene zaupne informacije, zato bi jih morala Komisija takoj razkriti. To naj bi zadostovalo za razveljavitev izpodbijanega sklepa. | 743 | The applicants maintain that the Commission was wrong to refuse them access to its communications with the KFST. While they accept that the Commission Notice on the rules for access to the Commission file in cases pursuant to Articles [101 TFEU] and [102 TFEU], Articles 53, 54 and 57 of the EEA Agreement and Council Regulation (EC) No 139/2004 (OJ 2005 C 325, p. 7) excludes correspondence between the Commission and the national competition authorities from the right of access to the file, it is settled case-law that, if the exceptional circumstances of the case so require, the Commission’s internal documents may be communicated to the parties. It is sufficient that the applicants demonstrate that there was even a small chance that the documents not disclosed during the administrative procedure could have been useful for their defence. That is the case here, since the correspondence with the KFST contains potentially exculpatory evidence, which could prove, from a factual aspect and contrary to the Commission’s contention, that there was uncertainty in competition law concerning settlement agreements specifying a reverse payment at the time when the applicants concluded the agreements at issue. In any event, the Commission’s subsequent disclosure of those documents shows that they contained no confidential information and the Commission ought therefore to have made them accessible immediately. That is a sufficient ground on which to annul the contested decision. |
| 744 | Komisija te trditve zavrača. | 744 | The Commission disputes those arguments. |
| 745 | V skladu s sodno prakso je mogoče ugotoviti kršitev pravice do obrambe – če je Komisija v upravnem postopku zavrnila prošnjo tožeče stranke za dostop do dokumentov, ki jih ni v preiskovalnem spisu – samo če se dokaže, da bi bil izid upravnega postopka lahko drugačen, če bi tožeča stranka v tem postopku imela dostop do zadevnih dokumentov (glej sodbo z dne 16. junija 2011, Solvay/Komisija, T‑186/06, ZOdl., EU:T:2011:276, točka 227 in navedena sodna praksa). | 745 | According to case-law, if, during the administrative procedure, the Commission has rejected an applicant’s request for access to documents which are not in the investigation file, an infringement of the rights of the defence may be found only if it is proved that the outcome of the administrative procedure might have been different if the applicant had had access to the documents in question during that procedure (see judgment of 16 June 2011 in Solvay v Commission, T‑186/06, ECR, EU:T:2011:276, paragraph 227 and the case-law cited). |
| 746 | Opozoriti je treba tudi na to, da kršitev pravice do obrambe vsekakor ne more sama po sebi vplivati na veljavnost izpodbijanega sklepa v celoti, če ta ne temelji samo na zadevnih informacijah. Nasprotno, v takem primeru mora Splošno sodišče pri proučitvi utemeljenosti odločbe prezreti vsebino teh dokumentov (glej v tem smislu sodbi z dne 7. junija 1983, Musique Diffusion française in drugi/Komisija, od 100/80 do 103/80, Recueil, EU:C:1983:158, točka 30, in z dne 14. maja 1998, Mo och Domsjö/Komisija, T‑352/94, Recueil, EU:T:1998:103, točka 74). | 746 | It must also be recalled that, in any event, an infringement of the rights of the defence is not capable, in itself, of affecting the validity of the contested decision as a whole where the decision is not based solely on the information in question. Instead, in such a case, it is for the Court to disregard the contents of those documents when it examines the validity of the decision (see, to that effect, judgments of 7 June 1983 in Musique Diffusion française and Others v Commission, 100/80 to 103/80, ECR, EU:C:1983:158, paragraph 30, and 14 May 1998 in Mo och Domsjö v Commission, T‑352/94, ECR, EU:T:1998:103, paragraph 74). |
| 747 | V obravnavani zadevi je treba v zvezi z obema dokumentoma iz korespondence med Komisijo in KFST spomniti, da ju je Komisija prostovoljno predložila v prilogi k svojemu odgovoru na tožbo kot odgovor na zahtevo tožečih strank. To je na eni strani poročilo KFST z dne 7. oktobra 2003 o preiskavi tega organa glede dejavnosti družbe Lundbeck in sporazumov, ki jih je sklenila na trgu zdravil proti depresiji, na drugi strani pa dopis KFST z dne 10. junija 2005 s povzetkom ugotovitev navedenega organa glede presoje teh sporazumov z vidika določb Pogodbe ES o svobodni konkurenci. | 747 | In the present case, as regards those two documents reporting the correspondence between the Commission and the KFST, it must be recalled that the Commission produced them voluntarily, in the annexes to its defence, in reply to the applicants’ request. The first of these is a report of the KFST of 7 October 2003 on the investigation carried out by that authority on Lundbeck’s activities and the agreements concluded by that company on the antidepressant pharmaceuticals market and the second is a memo of the KFST of 10 June 2005 stating, in summary, the conclusions of that authority on the assessment of those agreements in the light of the provisions of the EC Treaty on free competition. |
| 748 | Najprej je treba ugotoviti, da to nista neposredna dokumenta Komisije ali njenih služb, ampak sporočili nacionalnega organa, pristojnega za konkurenco. V skladu s sodno prakso pa nacionalni organi, pristojni za konkurenco, ker niso pristojni za izdajo negativne odločbe, to je odločbe o ugotovitvi neobstoja kršitve člena 101 PDEU, pri podjetjih ne morejo vzbuditi legitimno pričakovanje, da njihovo ravnanje ne krši navedene določbe (glej v tem smislu sodbo z dne 18. junija 2013, Schenker & Co. in drugi, C‑681/11, ZOdl., EU:C:2013:404, točka 42 in navedena sodna praksa). Zato se tožeči stranki, tudi če bi bila v teh dveh dokumentih ugotovljena odsotnost kršitve ali ovržena teorija Komisije iz izpodbijanega sklepa, nanju ne bi mogli uspešno sklicevati kot na razbremenilna dokaza, ker tudi če bi bila tožečima strankama sporočena med upravnim postopkom, taka komunikacija ne bi mogla vplivati na njegov izid. | 748 | It must be held, first, that these are not documents issued directly by the Commission or its departments, but communications from a national competition authority. According to case-law, national competition authorities cannot cause undertakings to entertain a legitimate expectation that their conduct does not infringe Article 101 TFEU, since they do not have the power to adopt a negative decision, that is to say, a decision concluding that there is no infringement of Article 101 TFEU (see, to that effect, judgment of 18 June 2013 in Schenker & Co. and Others, C‑681/11, ECR, EU:C:2013:404, paragraph 42 and the case-law cited). Accordingly, even if they had found that there was no infringement or called into question the theory adopted by the Commission in the contested decision, those documents could not properly be relied on as exculpatory evidence, since, even if they had been sent to the applicants during the administrative procedure, such a communication would have had no effect on the outcome of that procedure. |
| 749 | Vsekakor pa ta dva dokumenta – glede na to, da se z njima ne more ovreči presoja Komisije v izpodbijanem sklepu o spornih sporazumih – to presojo celo krepita, ker ti sporazumi po mnenju KFST iz njegovega poročila z dne 7. oktobra 2003 lahko vplivajo na konkurenco, saj je družba Lundbeck plačala konkurentom za to, da ne vstopijo na trg, zaradi česar so se nedvomno zvišale cene. Komisija je zato presodila, da ti sporazumi pomenijo zelo resno kršitev člena 101 PDEU. | 749 | In any event, those documents, far from calling into question the Commission’s assessment of the agreements at issue in the contested decision, rather reinforce it, given that, in the KFST’s view, in its report of 7 October 2003, the agreements at issue could influence competition, since Lundbeck had paid competitors to stay out of the market, leading indisputably to higher prices. The Commission therefore considered that those agreements constituted very serious infringements of Article 101 TFEU. |
| 750 | Čeprav je res, da iz dopisa KFST z dne 10. junija 2005 izhaja, da je po mnenju Komisije obstajal dvom, ali so bili ti sporazumi protikonkurenčni ali ne, zlasti zaradi višine plačila družbe Lundbeck generičnim podjetjem, je treba opozoriti, da je bila to zgolj predhodna presoja Komisije in da je na podlagi teh informacij sklenila uvesti širšo preiskavo o tej vrsti sporazumov v farmacevtskem sektorju, da bi oblikovala podrobnejše stališče o delovanju tega sektorja in združljivosti takih sporazumov s členoma 101 in 102 PDEU. Po tej preiskavi pa je Komisija zoper družbo Lundbeck in generična podjetja uvedla postopek na podlagi člena 101(1) PDEU. | 750 | While it is true that it is also apparent from the memo of the KFST of 10 June 2005 that, in the Commission’s view, there was doubt as to whether such agreements were anticompetitive or not, in the light in particular of the size of the payment made by Lundbeck to the generic undertakings, it must be held that that was merely a preliminary assessment by the Commission and that, as a result of that information, the Commission decided to initiate a wider investigation on that type of agreement in the pharmaceutical sector in order to form a more accurate opinion on the operation of that sector and the compatibility of such agreements with Articles 101 TFEU and 102 TFEU. Following that investigation, the Commission opened a procedure on the basis of Article 101(1) TFEU against Lundbeck and the generic undertakings. |
| 751 | Poleg tega iz navedenega sporočila KFST izhaja tudi, da je Komisija bistven pomen pripisovala dejstvu, da je visoko obrnjeno plačilo lahko indic za to, da je proizvajalec originalnih zdravil plačal generičnim podjetjem za to, da ostanejo zunaj trga. Iz navedenega sporočila izhaja, da je „vprašanje upravičenosti sporazuma odvisno med drugim od višine plačila“, da „če to pokrije samo pričakovane stroške spora pred sodišči, bi tak sporazum lahko bil zunaj področja uporabe člena [101] ali [102 PDEU]“, če pa je, „nasprotno, plačilo višje, ga je mogoče razumeti kot način plačila konkurentom, da ostanejo zunaj trga, kar je v nasprotju s členom [101] ali [102 PDEU]“. Iz izpodbijanega sklepa pa jasno izhaja, da je bilo to, da so bila obrnjena plačila iz spornih sporazumov v obravnavani zadevi visoka in so v glavnem ustrezala pričakovanim donosom generičnih podjetij ob vstopu na trg in ne stroškom morebitnih sporov, ki bi se jim izognilo, odločilno za ugotovitev obstoja kršitve člena 101(1) PDEU (točke 354, 414 in 415 zgoraj). | 751 | Furthermore, it is also clear from that memo of the KFST that the Commission attached considerable importance to the fact that a large reverse payment could be an indication that the originator undertaking had paid the generic undertakings to stay out of the market. It is clear from that memo that ‘whether the agreement can be justified ... depends, among other things, on the size of the payment’, that, ‘[i]f the payment only covers the costs that can be expected if the case is taken to court, then the agreement might fall out of the scope of Articles [101 TFEU] and [102 TFEU]’ and that ‘[h]owever, if the payment is more substantial it can be seen as a way of paying your competitors to stay out of the market and thereby an infringement of Article [101 TFEU] or [102 TFEU]’. It is also clear from the contested decision that the fact that the reverse payments contained in the agreements at issue in the present case were substantial and corresponded roughly to the profits expected by the generic undertakings in the event of market entry, and not the cost of potential litigation which had been avoided, was a key factor in concluding that there was an infringement of Article 101(1) TFEU (paragraphs 354, 414 and 415 above). |
| 752 | Tožeči stranki torej napačno trdita, da bi bila ta dva dokumenta koristna za njuno obrambo, če bi ji bila sporočena nemudoma med upravnim postopkom, ker dopuščata samo trditev, da je takrat obstajal dvom, ali bi bilo mogoče sporne sporazume takoj, brez poglobljene analize, opredeliti kot kršitev konkurence zaradi cilja v smislu člena 101(1) PDEU. Sodna praksa pa ne zahteva, da bi bilo treba sporazum opredeliti kot na prvi pogled ali nedvomno dovolj škodljiv za konkurenco brez poglobljene analize njegove vsebine, namena ter gospodarskih in pravnih okoliščin njegove sklenitve, zato da bi ga bilo mogoče opredeliti kot omejitev konkurence zaradi cilja v smislu navedene določbe (točke od 338 do 344 in 438 zgoraj). | 752 | The applicants are therefore wrong to state that those documents could have been useful for their defence if they had been received immediately during the administrative procedure, since they only permit the claim that there was doubt, at the time, as to whether the agreements at issue could be classified immediately, without detailed examination, as restrictions of competition by object within the meaning of Article 101(1) TFEU. The case-law does not, however, require that an agreement be considered to be prima facie or undoubtedly sufficiently harmful to competition, without a detailed examination of its content, purpose, legal and economic context in which it occurs, in order to be regarded as a restriction on competition by object within the meaning of that provision (paragraphs 338 to 344 and 438 above). |
| 753 | Zato je treba razsoditi, da pravica tožečih strank do obrambe v obravnavani zadevi ni bila kršena, ker se ni izkazalo, da bi se upravni postopek končal drugače, če bi med tem postopkom imeli dostop do zadevnih dokumentov (točka 745 zgoraj). | 753 | It must be held, accordingly, that the applicants’ rights of defence were not infringed in the present case, in so far as it does not appear that the administrative procedure could have led to a different result in the event that they had had access to the documents in question during that procedure (paragraph 745 above). |
| 754 | Zato je treba zavrniti drugi del in osmi tožbeni razlog v celoti. | 754 | Accordingly, the second part of the plea and the eighth plea in law must be rejected in their entirety. |
| V – Deveti tožbeni razlog: podredno, očitno napačna uporaba prava pri naložitvi glob družbi Lundbeck | V – The ninth plea in law, alleging, in the alternative that the imposition of fines on Lundbeck is vitiated by a manifest error of law |
| 755 | Tožeči stranki trdita, prvič, da ni predhodnih primerov s presojo sporazumov o patentni poravnavi, in drugič, da za patentne poravnave ni uporabljiva sodba z dne 1. julija 2010, AstraZeneca/Komisija (T‑321/05, ZOdl., EU:T:2010:266), zato za naložitev glob njima ni bilo nobene pravne podlage in da je bilo to v nasprotju z načelom pravne varnosti. | 755 | The applicants claim, first, that there are no earlier cases assessing patent settlement agreements and, secondly, that the judgment of 1 July 2010 in AstraZeneca v Commission (T‑321/05, ECR, EU:T:2010:266) cannot be applied to patent settlement agreements, so that the imposition of fines in relation to them was devoid of any foundation in law and was contrary to the principle of legal certainty. |
| 756 | Komisija te trditve zavrača. | 756 | The Commission disputes those arguments. |
| A – Prvi del | A – The first part |
| 757 | Tožeči stranki najprej trdita, da tudi če bi Komisija utemeljeno sklepala, da se je s spornimi sporazumi kršil člen 101 PDEU, ni bilo nobenega upravičenega razloga za to, da jima v obravnavani zadevi naloži globe, ker je šlo za nova in zapletena dejanska in pravna vprašanja, kar naj bi Komisija sicer priznavala. Z naložitvijo glob v takem primeru naj bi bili kršeni načeli pravne varnosti ter zakonitosti kaznivih dejanj in kazni (nullum crimen nulla poena sine lege). Sicer pa naj bi bilo v odgovoru na tožbo priznano, da gre za prvi sklep Komisije, s katerim je bila ugotovljena kršitev v zvezi s tako imenovanimi sporazumi „pay for delay“. | 757 | The applicants claim, first of all, that on the assumption that the Commission was correct to conclude that the agreements at issue had infringed Article 101 TFEU, there was no valid ground for imposing fines on them in the present case, because of the novelty and complexity of the factual and legal issues raised, which, moreover, the Commission acknowledges. The imposition of fines in such a situation fails to observe the principle of legal certainty and the principle that offences and penalties must have a proper legal basis (nullum crimen, nulla poena sine lege). Furthermore, the defence recognises that this is the first Commission decision finding an infringement in relation to ‘pay for delay’ agreements (agreements intended to delay the market entry of generics in exchange for payment). |
| 758 | Obstoječa sodna praksa, zlasti zgoraj v točki 341 navedena sodba BIDS (EU:C:2008:643), naj ne bi vsebovala nobene usmeritve, na podlagi katere bi bilo mogoče predvideti, da bodo obrnjena plačila iz spornih sporazumov odločilna za to, da bo Komisija ugotovila njihovo neskladnost s členom 101(1) PDEU. Komisija naj bi namreč trdila, da če ti sporazumi ne bi določali obrnjenih plačil, bi bili načeloma zakonito sredstvo za spoštovanje patentov družbe Lundbeck. Sicer pa tožeči stranki trdita, da zgoraj v točki 341 navedena sodba BIDS (EU:C:2008:643) ob sklenitvi spornih sporazumov še ni bila izdana. | 758 | The existing case-law, in particular the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643), provided no guidance to the effect that the reverse payments specified in the agreements at issue would serve as the decisive element for the Commission’s finding that the agreements infringed Article 101(1) TFEU. Indeed, the Commission maintained that, if those agreements had not made provision for reverse payments, they would in principle have been legitimate tools that would allow Lundbeck’s patents to be enforced. Moreover, the applicants claim that the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643), had not been delivered at the time when the agreements at issue were concluded. |
| 759 | Poleg tega naj bi KFST na začetku leta 2004 navedel ključne dejavnike glede pravne negotovosti v zvezi s patentnimi sporazumi, ki določajo obrnjena plačila. Natančneje, sporočilo za javnost KFST z dne 28. februarja 2004 naj bi jasno kazalo na to, da je Komisija takrat menila, da so bili zneski plačil družbe Lundbeck taki, da ni bilo mogoče utemeljeno dokazati, da se je z njimi plačalo konkurentu, da ostane zunaj trga. Sicer pa naj bi to, da je Komisija potrebovala deset let za oblikovanje stališča do pravne opredelitve sporazumov z določenim obrnjenim plačilom, kazalo na izredno zapletenost in zelo veliko novost vprašanj v zvezi s tem. | 759 | In addition, in early 2004, the KFST gave key indications as to the legal uncertainty surrounding reverse payment settlements. In particular, the KFST press release of 28 January 2004 shows that the Commission considered at the time that the amounts of the payments made by Lundbeck were such that it was not possible to show plausibly that they served as compensation in order to keep a competitor out of the market. Furthermore, the fact that the Commission took more than a decade to form a view on the legal characterisation of agreements specifying a reverse payment demonstrates the extreme complexity and the very great novelty of the underlying issues. |
| 760 | Komisija te trditve zavrača. | 760 | The Commission disputes those arguments. |
| 761 | Spomniti je treba, da načelo pravne varnosti zahteva, da ureditev Unije osebam, na katere se nanaša, omogoči, da se natančno seznanijo z obsegom obveznosti, ki jim jih nalaga, in da se lahko nedvoumno seznanijo s svojimi pravicami in obveznostmi ter ukrepajo v skladu z njimi (sodba z dne 29. marca 2011, ArcelorMittal Luxembourg/Komisija ter Komisija/ArcelorMittal Luxembourg in drugi, C‑201/09 P in C‑216/09 P, ZOdl., EU:C:2011:190, točka 68 in navedena sodna praksa). | 761 | The principle of legal certainty requires that EU rules enable those concerned to know precisely the extent of the obligations which are imposed on them, and that those persons must be able to ascertain unequivocally what their rights and obligations are and take steps accordingly (see judgment of 29 March 2011 in ArcelorMittal Luxembourg v Commission and Commission v ArcelorMittal Luxembourg and Others, C‑201/09 P and C‑216/09 P, ECR, EU:C:2011:190, paragraph 68 and the case-law cited). |
| 762 | Vendar je glede vprašanja, ali je bila kršitev storjena naklepno ali iz malomarnosti in ali jo je zato mogoče kaznovati z globo v skladu s členom 23(2), prvi pododstavek, Uredbe št. 1/2003, iz sodne prakse razvidno, da je ta pogoj izpolnjen, če zadevno podjetje ne more prezreti, da je njegovo ravnanje protikonkurenčno, ne glede na to, ali se zaveda, da je kršilo pravila o konkurenci iz Pogodbe (glej zgoraj v točki 748 navedeno sodbo Schenker & Co. in drugi, EU:C:2013:404, točka 37 in navedena sodna praksa). | 762 | However, with regard to whether an offence was committed intentionally or negligently and is therefore liable to be penalised by the imposition of a fine in accordance with the first subparagraph of Article 23(2) of Regulation No 1/2003, it is settled case-law that that condition is satisfied where the undertaking concerned cannot be unaware of the anticompetitive nature of its conduct, whether or not it is aware that it is infringing the competition rules of the Treaty (see judgment in Schenker & Co. and Others, cited in paragraph 748 above, EU:C:2013:404, paragraph 37 and the case-law cited). |
| 763 | Dalje, spomniti je treba, da načel zakonitosti kazni in pravne varnosti, določenih v členu 7 Evropske konvencije o človekovih pravicah in temeljnih svoboščinah, podpisane v Rimu 4. novembra 1950, in členu 49 Listine Unije o temeljnih pravicah, ni mogoče razlagati tako, da predpisujeta postopno pojasnjevanje pravil glede kazenske odgovornosti, temveč da lahko nasprotujeta retroaktivni uporabi nove razlage predpisa, ki določa kršitev (glej v tem smislu zgoraj v točki 113 navedeno sodbo z dne 10. julija 2014, Telefónica in Telefónica de España/Komisija, EU:C:2014:2062, točka 148 in sodna praksa). | 763 | Next, it must be noted that the principle of legal certainty and the principle that penalties must have a proper legal basis, laid down by Article 7 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950, and Article 49 of the Charter of Fundamental Rights of the European Union, cannot be interpreted as prohibiting the gradual clarification of the rules of liability but may preclude the retroactive application of a new interpretation of a rule establishing an offence (see, to that effect, judgment of 10 July 2014 in Telefónica and Telefónica de España v Commission, cited in paragraph 113 above, EU:C:2014:2062, paragraph 148 and the case-law cited). |
| 764 | V obravnavani zadevi v nasprotju z zatrjevanjem tožečih strank ni bilo nepredvidljivo, da bi bili lahko sporazumi, s katerimi je proizvajalec originalnih zdravil z znatnimi obrnjenimi plačili lahko izločil potencialne konkurente s trga za določen čas, v nasprotju s členom 101(1) PDEU, ne glede na to, ali presegajo obseg patentov ali ne (glej točke od 487 do 491 zgoraj). | 764 | In the present case, contrary to what the applicants claim, it was not unforeseeable that agreements by which the originator company was able to remove potential competitors from the market for a specified period, by means of significant reverse payments, might be contrary to Article 101(1) TFEU, whether or not they went beyond the scope of that company’s patents (see paragraphs 487 to 491). |
| 765 | Kot je Komisija utemeljeno ugotovila v točkah 1312 in 1313 obrazložitve izpodbijanega sklepa, je bilo mogoče na podlagi jezikovne razlage člena 101(1) PDEU razumeti, da sporazumi med konkurenti z namenom izključitve nekaterih med njimi s trga niso zakoniti. Sporazumi o razdelitvi ali izključitvi s trga so namreč med najresnejšimi kršitvami konkurence, ki so izrecno navedene v členu 101(1) PDEU (točka 338 zgoraj). | 765 | As the Commission stated correctly in recitals 1312 and 1313 of the contested decision, a literal reading of Article 101(1) TFEU made it clear that agreements between competitors for the exclusion of some of them from the market were illegal. Market-sharing or exclusion agreements are among the most serious restrictions of competition expressly referred to in Article 101(1) TFEU (paragraph 338 above). |
| 766 | Tožeči strani na podlagi tega, da so bili v obravnavani zadevi sporazumi sklenjeni v obliki poravnav s področja pravic intelektualne lastnine, ne moreta trditi, da je bila nezakonitost teh sporazumov po pravu konkurence povsem nova ali nepredvidljiva. | 766 | The fact that, in the present case, the agreements at issue were concluded in the form of settlement agreements concerning intellectual property rights cannot allow the applicants to infer that their unlawfulness under competition law was completely novel or unforeseeable. |
| 767 | Obseg pojma predvidljivosti je pretežno odvisen od vsebine besedila, ki ga zadeva, področja, ki ga pokriva, ter od števila in statusa njegovih naslovnikov. Zakon je lahko še vedno v skladu z zahtevo po predvidljivosti, tudi če mora zadevna oseba uporabiti pravno svetovanje za to, da v danih okoliščinah ustrezno presodi posledice določenega dejanja. To zlasti velja za strokovnjake, ki so vajeni, da morajo izkazovati izredno skrbnost pri opravljanju svoje dejavnosti. Zato je mogoče od njih pričakovati posebno skrbnost pri oceni tveganja, ki jih prinaša njihova dejavnost (glej sodbo z dne 28. junija 2005, Dansk Rørindustri in drugi/Komisija, C‑189/02 P, C‑202/02 P, od C‑205/02 P do C‑208/02 P in C‑213/02 P, ZOdl., EU:C:2005:408, točka 219 in navedena sodna praksa). | 767 | The scope of the notion of foreseeability depends to a considerable degree on the content of the text in issue, the field it covers and the number and status of those to whom it is addressed. A law may still satisfy the requirement of foreseeability even if the person concerned has to take appropriate legal advice to assess, to a degree that is reasonable in the circumstances, the consequences which a given action may entail. This is particularly true in relation to persons carrying on a professional activity, who are used to having to proceed with a high degree of caution when pursuing their occupation. Such persons can therefore be expected to take special care in evaluating the risk that such an activity entails (judgment of 28 June 2005 in Dansk Rørindustri and Others v Commission, C‑189/02 P, C‑202/02 P, C‑205/02 P to C‑208/02 P and C‑213/02 P, ECR, EU:C:2005:408, paragraph 219 and the case-law cited). |
| 768 | Nobena od trditev tožečih strank te ugotovitve ne more ovreči. | 768 | None of the arguments put forward by the applicants can call that conclusion into question. |
| 769 | Prvič, čeprav je namreč res, da je bila zgoraj v točki 341 navedena sodba BIDS (EU:C:2008:643), na katero se Komisija sklicuje v izpodbijanem sklepu, izdana po sklenitvi spornih sporazumov, pa je bilo že prej v sodni praksi pojasnjeno, da sporazum ni izvzet iz prava konkurence samo zato, ker se nanaša na patent ali se z njim s poravnavo rešuje patentni spor (glej v tem smislu zgoraj v točki 427 navedeno sodbo Bayer in Maschinenfabrik Hennecke, EU:C:1988:448, točka 15), in da se nadomestitev odločitev nacionalnih sodišč z diskrecijsko presojo ene od strank očitno ni nanašala na konkreten predmet patenta in je pomenila omejitev svobodne konkurence (glej v tem smislu zgoraj v točki 119 navedeno sodbo Windsurfing International/Komisija, EU:C:1986:75, točki 52 in 92). | 769 | First, while it is true that the BIDS judgment, cited in paragraph 341 above (EU:C:2008:643), relied on by the Commission in the contested decision, was delivered after the agreements at issue had been concluded, the earlier case-law nevertheless explained that an agreement was not exempt from competition law merely because it concerned a patent or was intended to settle a patent dispute (see, to that effect, judgment in Bayer and Maschinenfabrik Hennecke, cited in paragraph 427 above, EU:C:1988:448, paragraph 15) and that substituting the discretion of one of the parties for decisions of the national courts in order to find that a patent had been infringed clearly did not relate to the specific subject matter of the patent and constituted a restriction on free competition (see, to that effect, the Windsurfing judgment, cited in paragraph 119 above, EU:C:1986:75, paragraphs 52 and 92). |
| 770 | V zgoraj v točki 117 navedeni sodbi Centrafarm in de Peijper (EU:C:1974:115, točki 39 in 40) je bilo pojasnjeno tudi, da se prepovedi iz člena 101 PDEU lahko uporabljajo za pogoje za izvrševanje pravice intelektualne lastnine, in da je lahko tako vsakokrat, kadar se izkaže, da je izvrševanje take pravice predmet, sredstvo ali posledica omejevalnega sporazuma. | 770 | The judgment in Centrafarm and de Peijper, cited in paragraph 117 above (EU:C:1974:114, paragraphs 39 and 40) also specified that the conditions under which an intellectual property right may be exercised could fall under the prohibitions laid down in Article 101 TFEU and that that may be the case whenever the exercise of such a right appears to be the object, the means or the consequence of a restrictive agreement. |
| 771 | Drugič, v zvezi z dokumenti KFST in še posebej sporočilom za javnost z dne 28. januarja 2004 je treba najprej spomniti, da ne gre za dokument Komisije, ki zato ne more ustvariti legitimnih pričakovanj tožečih strank. Poleg tega je treba spomniti, da nacionalni organi, pristojni za konkurenco, niso pristojni za sprejetje negativne odločbe, torej odločbe o ugotovitvi neobstoja kršitve člena 101(1) PDEU (točka 746 zgoraj). | 771 | Secondly, as regards the KFST documents, in particular, the press release of 28 January 2004, it must be noted, first of all, that this is not a document originating from the Commission and therefore could not, as such, give rise to legitimate expectations on the part of the applicants. Moreover, it must be noted that national competition authorities do not have the power to adopt a negative decision, that is to say, a decision concluding that there is no infringement of Article 101(1) TFEU (paragraph 748 above). |
| 772 | Iz sporočila za javnost KFST tudi jasno izhaja, da so sporazumi s ciljem odplačne izključitve konkurenta s trga protikonkurenčni. Komisija je po koncu svoje podrobne preiskave farmacevtskega sektorja lahko natančneje opredelila svoj pristop in celovito razumela protikonkurenčnost nekaterih sporazumov, zlasti tistih z znatnimi obrnjenimi plačili kot v obravnavani zadevi (točke od 349 do 403 zgoraj). | 772 | Furthermore, it is clear from the KFST press release that agreements whose object is to acquire market exclusion of a competitor are anticompetitive. Following its detailed investigation of the pharmaceutical sector, the Commission was able to refine its approach and fully comprehend the anticompetitive nature of certain agreements, in particular where those agreements involved a significant reverse payment, as in the present case (paragraphs 349 to 403 above). |
| 773 | Tretjič, ker se tožeči stranki pri trditvi, da je bila v obravnavani zadevi ugotovljena kršitev nova in bi zahtevala zgolj simbolično globo, opirata na predhodno prakso Komisije, je treba spomniti, da ima Komisija v skladu s sodno prakso diskrecijsko pravico pri določanju zneskov glob, s katerimi želi usmerjati ravnanje podjetij v smeri spoštovanja pravil o konkurenci. Komisiji dejstvo, da je v preteklosti uporabljala globe na neki določeni ravni za določene vrste kršitev, ne jemlje možnosti te ravni povišati znotraj meja, določenih v Uredbi št. 1/2003, če je to potrebno za zagotovitev izvajanja konkurenčne politike Skupnosti. Učinkovita uporaba pravil Skupnosti o konkurenci, nasprotno, zahteva, da lahko Komisija v vsakem trenutku prilagodi raven kazni glede na potrebe te politike (glej sodbo z dne 25. oktobra 2011, Aragonesas Industrias y Energía/Komisija, T‑348/08, ZOdl., EU:T:2011:621, točka 293 in navedena sodna praksa). | 773 | Thirdly, in so far as the applicants rely on the earlier practice of the Commission in order to claim that the infringement found in the present case was new and required only a symbolic fine, it must be observed that, according to case-law, the Commission has a margin of discretion when setting the amount of fines in order that it may direct the conduct of undertakings towards compliance with the competition rules. The fact that in the past the Commission has applied fines of a particular level for certain types of infringements does not mean that it is precluded from increasing that level within the limits indicated in Regulation No 1/2003, if that is necessary to ensure implementation of European Union competition policy. The proper application of the European Union competition rules in fact requires that the Commission may at any time adjust the level of fines to the needs of that policy (see judgment of 25 October 2011 in Aragonesas Industrias y Energía v Commission, T‑348/08, ECR, EU:T:2011:621, paragraph 293 and the case-law cited). |
| 774 | Poleg tega to, da je Komisija v preteklosti menila, da sporazum določene vrste zaradi cilja ne omejuje konkurence, samo po sebi ne preprečuje, da bi v prihodnje po posamičnem in podrobnem preizkusu spornih ukrepov menila drugače. Zato se ne zahteva, da Komisija istovrstni sporazum opredeli kot nezakonit, zato da bi ga bilo mogoče obravnavati kot omejevalen zaradi cilja (točka 438 zgoraj). | 774 | Furthermore, the fact that in the past the Commission did not take the view that a certain kind of agreement was, by its very object, restrictive of competition cannot, in itself, prevent it from doing so in the future following an individual, detailed examination of the measures at issue in the light of their content, purpose and context. There is therefore no requirement for the same type of agreement to have been found unlawful by the Commission in order for them to be considered restrictive of competition by object (paragraph 438 above). |
| 775 | V skladu s sodno prakso tudi ni potrebno, da je sporazum na prvi pogled ali nedvomno dovolj škodljiv za konkurenco brez poglobljene analize njegove vsebine, namena ter gospodarskih in pravnih okoliščin njegove sklenitve, zato da bi ga bilo mogoče opredeliti kot omejitev konkurence zaradi cilja v smislu navedene določbe (točka 752 zgoraj). | 775 | Nor does the case-law require that an agreement be considered to be prima facie or undoubtedly sufficiently harmful to competition, without a detailed examination of its content, purpose, legal and economic context, in order to be regarded as a restriction on competition by object within the meaning of that provision (paragraph 752 above). |
| 776 | Nazadnje, iz izpodbijanega sklepa izhaja, da so nekatera generična podjetja podobne sporazume, kot so sporni sporazumi, dejansko razumela kot protikonkurenčne in zavrnila sklenitev teh sporazumov prav iz tega razloga (glej točko 190 obrazložitve izpodbijanega sklepa). Podobno se je eden od zaposlenih pri družbi Lundbeck odzval na nekatera izmenjana elektronska sporočila, v katerih je določena cena in količina citaloprama, ki ga je družba Lundbeck kupovala od podjetja Merck (GUK) v skladu s spornimi sporazumi, z navedbo, da „ostro zavrača vsebino tega elektronskega sporočila“, in da se „[ne moremo] in [ne smemo] dogovarjati o prodajnih cenah“, ker „to ne bi bilo zakonito“ (točka 265 obrazložitve izpodbijanega sklepa). Družba Lundbeck je v zvezi s sporazumom Ranbaxy med pogajanji o tem sporazumu navedla tudi, da bi bilo to drago in težko z vidika prava konkurence (glej točko 188 obrazložitve izpodbijanega sklepa). | 776 | Finally, it is apparent from the contested decision that certain generic undertakings were aware of the infringing nature of agreements similar to the agreements at issue and refused to enter into such agreements precisely for that reason (see recital 190 of the contested decision). Similarly, an employee of Lundbeck reacted to certain email exchanges establishing the price and volume of citalopram purchased by Merck (GUK) from Lundbeck under the agreements at issue, stating that he ‘strongly disagree[d] with the content of this email’ and that ‘[they could not] and [would] not agree selling prices’, since ‘this [was] illegal’ (recital 265 of the contested decision). As regards the Ranbaxy agreement, Lundbeck also stated, during the negotiations concerning that agreement, that it would be costly and difficult, in particular from a competition law perspective (see recital 188 of the contested decision). |
| 777 | Ti dejavniki dokazujejo, da bi stranke spornih sporazumov omejitve konkurence iz teh sporazumov – glede na to, da te takrat niso bile nepredvidljive – lahko razumno razumele kot kršitve člena 101(1) PDEU. | 777 | Those factors show that, far from being unforeseeable at the time, the restrictions on competition set out by the agreements at issue could reasonably have been perceived by the parties to those agreements as being contrary to Article 101(1) TFEU. |
| 778 | Zato tožeči stranki napačno trdita, da je Komisija v obravnavani zadevi kršila načeli pravne varnosti in zakonitosti kazni. | 778 | Consequently, the applicants are wrong to claim that the Commission infringed the principles of legal certainty and the principle that penalties must have a proper legal basis in the present case. |
| 779 | Prvi del je torej treba zavrniti. | 779 | The first part must therefore be rejected. |
| B – Drugi del | B – The second part |
| 780 | Tožeči stranki menita, da iz zgoraj v točki 755 navedene sodbe AstraZeneca/Komisija (EU:T:2010:266) izhaja, da glob ni upravičeno naložiti zaradi novosti zadeve, če se na eni strani na obravnavano ravnanje ne nanaša nobena predhodna sodna praksa, in če na drugi strani to ravnanje ni zelo protikonkurenčno, tako da zadevno podjetje ni moglo pričakovati, da ni zakonito. Po njunem mnenju pa je v točki 1300 obrazložitve izpodbijanega sklepa priznano, da je prvi pogoj v obravnavani zadevi izpolnjen, kar zadeva drugi pogoj pa sporni sporazumi niso zlorabna ravnanja, kot so bila tista v zadevi, v kateri je bila izdana zgoraj v točki 755 navedena sodba AstraZeneca/Komisija (EU:T:2010:266). Poleg tega naj podjetja, ki tako kot družba Lundbeck niso v prevladujočem položaju, ne bi nosila nobene posebne odgovornosti. Komisija naj zato v preiskavi na podlagi člena 101(1) PDEU ne bi smela ponovno uporabiti standarde iz zadeve, ki se nanaša na zlorabo prevladujočega položaja. | 780 | According to the applicants, it follows from the judgment in AstraZeneca v Commission, cited in paragraph 755 above (EU:T:2010:266) that imposing fines is not justified, on account of the novelty of a case, where (i) no previous case-law covered the conduct under consideration and (ii) that conduct is not highly anticompetitive, so that the undertaking concerned could not expect it to be illegal. In the applicants’ submission, recital 1300 of the contested decision acknowledges that the first condition is met in the present case, while, as regards the second condition, the agreements at issue are not abusive practices, such as those at issue in the case that gave rise to the judgment in AstraZeneca v Commission, cited in paragraph 755 above (EU:T:2010:266). In addition, no special responsibility is borne by undertakings which, like Lundbeck, are not in a dominant position. The Commission cannot therefore recycle in an investigation pursuant to Article 101(1) TFEU standards set in a case relating to an abuse of a dominant position. |
| 781 | Komisija te trditve zavrača. | 781 | The Commission disputes those arguments. |
| 782 | V zvezi s tem je treba ugotoviti – kot je Komisija opozorila v točki 1300 obrazložitve izpodbijanega sklepa – da je Sodišče v zgoraj v točki 162 navedeni sodbi z dne 6. decembra 2012, AstraZeneca/Komisija (EU:C:2012:770), v odgovor na podobno trditev tožeče stranke v navedeni zadevi razsodilo, da „čeprav Komisija in sodišči Unije še niso imeli možnosti, da bi se posebej izrekli o ravnanju, kakršno je značilno za ti zlorabi, se je skupina [AstraZeneca] zavedala močne protikonkurenčnosti svojega ravnanja in bi morala pričakovati, da to ni skladno s pravili konkurence prava Unije“. Tožeči stranki torej na podlagi navedene sodbe napačno sklepata, da Komisija ne sme naložiti globe brez predhodnih podobnih primerov, o katerih sta odločili sodišči Unije (točki 438 in 774 zgoraj). | 782 | It must be noted, in that regard, as the Commission pointed out in recital 1300 of the contested decision that, in its judgment of 6 December 2012 in AstraZeneca v Commission, cited in paragraph 162 above (EU:C:2012:770), the Court of Justice held, in reply to the applicant’s similar argument in that case, that ‘even though the Commission and the Courts of the European Union had not yet had the opportunity to rule specifically on conduct such as that which characterised those abuses, [AstraZeneca] was aware of the highly anticompetitive nature of its conduct and should have expected it to be incompatible with competition rules under EU law’. The applicants are therefore wrong to infer from that judgment that the Commission cannot impose a fine in the absence of similar precedents issued by the Courts of the European Union (paragraphs 438 and 774 above). |
| 783 | Poleg tega ravnanje tožečih strank v obravnavani zadevi – tako kot v zadevi, v kateri je bila izdana zgoraj v točki 755 navedena sodba AstraZeneca (EU:T:2010:266) – očitno ni del običajnega konkurenčnega procesa, ker se je z njim želelo izključiti potencialne konkurente s trga z znatnimi obrnjenimi plačili. To, da so lahko nekatere patentne poravnave tudi zakonite in se z njimi ne kršijo določbe Pogodbe o prosti konkurenci, ne spremeni dejstva, da so bili v obravnavani zadevi sporazumi, ki sta jih sklenili tožeči stranki, protikonkurenčni iz razlogov, ki jih je Komisija navedla v izpodbijanem sklepu (točka 354 zgoraj ter točki 661 in 662 obrazložitve izpodbijanega sklepa). | 783 | Furthermore, just as in the case that gave rise to the judgment in AstraZeneca, cited in paragraph 755 above (EU:T:2010:266), the applicants’ conduct in the present case was clearly not part of normal competition, since they aimed to exclude potential competitors from the market by means of significant reverse payments. The fact that some patent settlement agreements, moreover, may be legitimate and not infringe the provisions of the Treaty on free competition does not alter the fact that, in the present case, the agreements at issue concluded by the applicants were anticompetitive, for the reasons set out by the Commission in the contested decision (see paragraph 354 above and recitals 661 and 662 of the contested decision). |
| 784 | Nazadnje, čeprav je res, da imajo podjetja v prevladujočem položaju v skladu s členom 102 PDEU posebno odgovornost, da se vzdržijo določene vrste enostranskih ravnanj, ki škodujejo konkurenci, kot so tista iz zgoraj v točki 755 navedene sodbe AstraZeneca (EU:T:2010:266), pa za vsa podjetja – ne glede na to, ali so v prevladujočem položaju ali ne – velja tudi člen 101 PDEU, če so izpolnjeni pogoji za njegovo uporabo, in jim je mogoče naložiti globe na tej podlagi. Komisija pa je v obravnavani zadevi uporabila prav ta zadnjenavedeni člen in ne člen 102 PDEU. | 784 | Finally, while it is true that undertakings in a dominant position have a special responsibility under Article 102 TFEU not to adopt certain types of unilateral conduct that restrict competition, such as those at issue in the judgment in AstraZeneca, cited in paragraph 755 above (EU:T:2010:266), it is nevertheless the case that all undertakings, whether in a dominant position or not, are equally subject to Article 101 TFEU where the conditions for application of that article are met and may have fines imposed on them in that regard. It is that provision, and not Article 102 TFEU, that the Commission applied in the present case. |
| 785 | Zato je treba drugi del in deveti tožbeni razlog v celoti zavrniti. | 785 | The second part must therefore be rejected, as must the ninth plea in law in its entirety. |
| VI – Deseti tožbeni razlog: še bolj podredno, očitno napačna uporaba prava in ugotovitev dejanskega stanja pri izračunu glob | VI – The tenth plea in law, alleging, further in the alternative, manifest errors of law and of fact in calculating the fines |
| 786 | Tožeči stranki trdita, da bi bilo treba v izpodbijanem sklepu pri izračunu zneska globe vsekakor, prvič, uporabiti nižjo stopnjo teže kršitve, drugič, upoštevati da so zatrjevane kršitve trajale kratek čas, tretjič, opustiti naložitev kakršnega koli dodatnega zneska, in četrtič, uporabiti olajševalne okoliščine. | 786 | The applicants maintain that when setting the fine in the contested decision, the Commission ought in any event, first, to have used a lower rate of gravity; secondly, to have taken account of the fact that the alleged infringements lasted a short time; thirdly, not to have imposed an additional amount; and, fourthly, to have applied mitigating circumstances. |
| 787 | Komisija te trditve zavrača. | 787 | The Commission disputes those arguments. |
| 788 | Uvodoma je treba spomniti, da je Komisija uporabila splošno metodologijo iz smernic iz leta 2006, ki temelji na vrednosti prodaje zadevnega proizvoda, neposredno ali posredno povezanega s kršitvijo, v upoštevnem geografskem območju znotraj ozemlja EGP (točki 13 in 19 navedenih smernic). Sprejet je bil delež 10 % ali 11 % glede na geografski obseg spornih sporazumov (glej točke od 68 do 75 zgoraj ter točke od 1316 do 1358 izpodbijanega sklepa). | 788 | It should be recalled, as a preliminary point, that, as regards the applicants, the Commission followed the general methodology described in the 2006 Guidelines, based on the value of sales of the relevant product to which the infringement directly or indirectly relates, in the relevant geographic area within the EEA (points 13 and 19 of those Guidelines). The figure adopted was 10% or 11%, depending on the geographic scope of the agreements at issue (see paragraphs 68 to 75 above and recitals 1316 to 1358 of the contested decision). |
| 789 | Opozoriti je treba tudi na to, da je treba v skladu z ustaljeno sodno prakso pri določanju zneska glob upoštevati trajanje kršitev in vse dejavnike, ki lahko vplivajo na presojo njihove teže, kot so ravnanje posameznega podjetja, vloga, ki jo je posamezno podjetje imelo pri izvajanju usklajenih ravnanj, dobiček, ki so ga podjetja lahko imela zaradi teh ravnanj, njihova velikost in vrednost zadevnega blaga ter nevarnost, ki jo ta vrsta kršitev pomeni (glej sodbo z dne 8. decembra 2011, KME Germany in drugi/Komisija, C‑272/09 P, ZOdl., EU:C:2011:810, točka 96 in navedena sodna praksa). | 789 | It must also be recalled that, according to settled case-law, in order to determine the amount of the fines that are to be imposed for infringement of the competition rules, it is necessary to take account of the duration of the infringements and all the factors capable of affecting the assessment of their gravity, such as the conduct of each of the undertakings, the role played by each of them in the establishment of the concerted practices, the profit which they were able to derive from those practices, their size, the value of the goods concerned and the threat that infringements of that type pose (see judgment of 8 December 2011 in KME Germany and Others v Commission, C‑272/09 P, ECR, EU:C:2011:810, paragraph 96 and the case-law cited). |
| 790 | Sodišče je tudi navedlo, da je treba upoštevati objektivne dejavnike, kot so vsebina in trajanje protikonkurenčnih ravnanj, njihovo število in intenzivnost, obseg prizadetega trga in škoda, povzročena gospodarskemu javnemu redu (glej zgoraj v točki 789 navedeno sodbo KME Germany in drugi/Komisija, EU:C:2011:810, točka 97 in navedena sodna praksa). | 790 | The Court of Justice has also stated that objective factors such as the content and duration of the anticompetitive conduct, the number of incidents and their intensity, the extent of the market affected and the damage to the economic public order must be taken into account (see judgment in KME Germany and Others v Commission, cited in paragraph 789 above, EU:C:2011:810, paragraph 97 and the case-law cited). |
| 791 | V zvezi s tem je treba spomniti, da je obveznost obrazložitve še posebej pomembna. Komisija mora svojo odločbo obrazložiti, zlasti pa pojasniti, kako je pretehtala in ocenila dejavnike, ki jih je upoštevala. Sodišče mora po uradni dolžnosti preveriti, ali je obrazložitev podana (glej v tem smislu zgoraj v točki 789 navedeno sodbo KME Germany in drugi/Komisija, EU:C:2011:810, točka 101 in navedena sodna praksa). | 791 | In that regard, it should be noted that the obligation to state reasons is of particular importance. The Commission must state the reasons for its decision and, in particular, explain the weighting and assessment of the factors taken into account. The Court must establish of its own motion that there is a statement of reasons (see, to that effect, judgment in KME Germany and Others v Commission, cited in paragraph 789 above, EU:C:2011:810, paragraph 101 and the case-law cited). |
| 792 | Poleg tega mora sodišče Unije na podlagi dokazov, ki jih stranka predloži v podporo razlogom, opraviti nadzor zakonitosti. Sodišče se pri tem nadzoru niti glede izbire dejavnikov, ki jih upošteva pri uporabi meril iz smernic, niti glede ocenjevanja teh dejavnikov ne sme opirati na polje proste presoje Komisije, da bi opustilo izvedbo temeljitega nadzora tako nad uporabo prava kot nad dejstvi (zgoraj v točki 789 navedena sodba KME Germany in drugi/Komisija, EU:C:2011:810, točka 102). | 792 | Furthermore, the Court must carry out the review of legality incumbent upon it on the basis of the evidence adduced by the applicant in support of the pleas in law put forward. In carrying out such a review, the Court cannot rely on the Commission’s margin of discretion — either as regards the choice of factors taken into account in the application of the criteria mentioned in the Guidelines or as regards the assessment of those factors — as a basis for dispensing with an in-depth review of the law and of the facts (judgment in KME Germany and Others v Commission, cited in paragraph 789 above, EU:C:2011:810, paragraph 102). |
| 793 | Nadzor zakonitosti je dopolnjen z neomejeno sodno pristojnostjo, ki je v skladu s členom 261 PDEU sodišču Unije priznana na podlagi člena 31 Uredbe št. 1/2003. Ta pristojnost sodišču omogoča, da opravi le nadzor zakonitosti sankcije in nadomesti presojo Komisije s svojo ter tako odpravi, zniža ali zviša naloženo globo ali periodično denarno kazen (glej v tem smislu zgoraj v točki 789 navedeno sodbo KME Germany in drugi/Komisija, EU:C:2011:816, točka 103 in navedena sodna praksa). | 793 | The review of legality is supplemented by the unlimited jurisdiction which the Court enjoys under Article 31 of Regulation No 1/2003, in accordance with Article 261 TFEU. That jurisdiction empowers the Court, in addition to carrying out a mere review of the lawfulness of the penalty, to substitute its own appraisal for the Commission’s and, consequently, to cancel, reduce or increase the fine or penalty payment imposed (see, to that effect, judgment in KME Germany and Others v Commission, cited in paragraph 789 above, EU:C:2011:810, paragraph 103 and the case-law cited). |
| 794 | Vendar je treba poudariti, da izvajanje neomejene pristojnosti ne pomeni enako kot nadzor po uradni dolžnosti, in spomniti, da je postopek pred sodišči Unije kontradiktoren. Razen razlogov javnega reda, kot je neobstoj obrazložitve izpodbijane odločbe, ki jih mora sodišče preizkusiti po uradni dolžnosti, mora razloge zoper izpodbijano odločbo navesti tožeča stranka in predložiti dokaze v podporo tem razlogom (zgoraj v točki 789 navedena sodba KME Germany in drugi/Komisija, EU:C:2011:810, točka 104). | 794 | It must, however, be pointed out that the exercise of unlimited jurisdiction is not a review that is conducted by the Court of its own motion, and that proceedings before the Court are inter partes. With the exception of pleas involving matters of public policy which the Court is required to raise of its own motion, such as the failure to state reasons for a contested decision, it is for the applicant to raise pleas in law against that decision and to adduce evidence in support of those pleas (judgment in KME Germany and Others v Commission, cited in paragraph 789 above, EU:C:2011:810, paragraph 104). |
| 795 | Na podlagi teh ugotovitev je treba preizkusiti trditve tožečih strank. | 795 | The applicants’ arguments must be assessed in the light of those considerations. |
| A – Prvi del | A – The first part |
| 796 | Na Tožeči stranki trdita, da sta stopnji teže kršitve, in sicer 11 % od vrednosti prodaje za sporazume s podjetji Merck (GUK), Alpharma in Ranbaxy ter 10 % za sporazume s podjetjem Arrow, previsoki. V izpodbijanem sklepu naj namreč ne bi bil upoštevan, na prvem mestu, omejen obseg omejitev iz spornih sporazumov, ki naj bi vsaj deloma spadale v obseg patentov družbe Lundbeck. Tržni delež družbe Lundbeck naj bi bil v večini držav članic EGP manjši od 19 %, geografski obseg sporazumov pa naj bi bil omejen na tiste države članice EGP, v katerih so imela generična podjetja dejanske možnosti za vstop na trg. | 796 | The applicants claim that the rates of gravity, fixed at 11% of the value of sales for the agreements with Merck (GUK), Alpharma and Ranbaxy, and 10% for the agreements with Arrow, are too high. They maintain, in the first place, that the contested decision fails to take account of the limited scope of the restrictions in the agreements at issue, which are, at least in part, within the scope of Lundbeck’s patents. Lundbeck’s market share was below 19% in most EEA countries and the geographic scope of the agreements ought to have been limited to the EEA countries in which the generic undertakings had realistic prospects of entering the market. |
| 797 | Na drugem mestu, v sklepu naj ne bi bilo upoštevano, da sporni sporazumi niso bili tajni in da so vsebovali klasične določbe za tovrstne sporazume, kar naj bi v skladu z upravno prakso Komisije upravičevalo nižjo stopnjo teže kršitve. Na tretjem mestu, sporni sporazumi naj ne bi bili usklajeni, kar naj bi bilo sicer v sklepu potrjeno. Komisija pa naj v preteklosti bodisi ne bi naložila nobene globe bodisi je za tovrstne neusklajene omejevalne sporazume določila najnižjo stopnjo teže kršitve. Sklep naj bi bil torej napačen, ker se v njem ugotavlja, da so sporni sporazumi resne kršitve člena 101 PDEU. Načelo sorazmernosti naj bi nasprotno zahtevalo, da se stopnja teže kršitve v obravnavani zadevi določi v najnižjem delu razpona. | 797 | In the second place, the decision fails to take account of the fact that the agreements at issue were not secret and that they contained standard clauses for that type of agreement, which justifies a lower rate of gravity, in accordance with the Commission’s practice when adopting decisions. In the third place, the agreements at issue are not collusive in nature, as, moreover, the contested decision recognises. In the past, the Commission has either not imposed a fine, or imposed a very low fine, or set the rate of gravity at the lowest end of the scale for this type of non-collusive agreement. The decision therefore errs where it finds that the agreements at issue constitute serious infringements of Article 101 TFEU. The principle of proportionality requires, on the contrary, that the rate of gravity in the present case be set at the lowest level of the scale. |
| 798 | Komisija te trditve zavrača. | 798 | The Commission disputes those arguments. |
| 799 | V zvezi s tem je treba spomniti, da bo v skladu s točko 21 smernic iz leta 2006 upoštevani delež vrednosti prodaje določen v višini do 30 % vrednosti prodaje. V točki 22 teh smernic je pojasnjeno, da bo Komisija pri odločitvi, ali bi moral biti delež vrednosti prodaje, ki se upošteva v posameznem primeru, v spodnjem ali zgornjem delu tega razpona, upoštevala več dejavnikov, kot so narava kršitve, skupni tržni delež vseh zadevnih podjetij, geografski obseg kršitve in dejstvo, ali je bila kršitev izvršena ali ne. | 799 | In that regard, it must be noted that, by virtue of point 21 of the 2006 Guidelines, the proportion of the value of sales will be set at a level of up to 30%. Point 22 of those guidelines specifies that in order to determine whether the proportion of the value of sales to be considered in a given case should be at the lower end or at the higher end of that scale, the Commission will have regard to a number of factors, such as the nature of the infringement, the combined market share of all the undertakings concerned, the geographic scope of the infringement and whether or not the infringement has been implemented. |
| 800 | Ugotoviti je treba, prvič, da je Komisija zadevne kršitve v obravnavani zadevi utemeljeno opredelila kot „resne“, ker je šlo za omejitve konkurence zaradi cilja, katerih škodljivost za konkurenco je bila zadostno dokazana, s tem, da so bili konkurenti plačani za to, da za določen čas ostanejo zunaj trga (točka 1331 obrazložitve izpodbijanega sklepa). | 800 | First, it must be noted that the Commission correctly classified the infringements in the present case as ‘serious’, in so far as they concerned restrictions of competition by object, whose harmful effect on competition was sufficiently established, consisting of paying competitors to stay out of the market for a specified period (recital 1331 of the contested decision). |
| 801 | S tem, da bi lahko nekatere omejitve iz spornih sporazumov spadale v obseg patentov družbe Lundbeck (ki so opredeljeni zgoraj v točkah 335 in 569), navedenih ugotovitev ni mogoče ovreči, ker gre samo za enega od dejavnikov, ki jih je Komisija upoštevala pri ugotavljanju obstoja omejitve zaradi cilja v obravnavani zadevi (točka 354 zgoraj). Zato ni pomembno, da so ti morebiti vsebovali tudi omejitve, ki spadajo v obseg teh patentov, ker je odločilno to – kot je Komisija ugotovila v izpodbijanem sklepu – da je v času sklenitve spornih sporazumov obstajala negotovost glede tega, ali je bil s proizvodi, ki so jih generična podjetja nameravala tržiti, kršen kateri od patentov družbe Lundbeck, da bi bilo mogoče veljavnost zadnjenavedenih izpodbijati na sodišču, in da sta si tožeči strani z znatnimi obrnjenimi plačili zagotovili, da generična podjetja med trajanjem spornih sporazumov ne bodo vstopila na trg (točki 363 in 429 zgoraj). Vsekakor je Komisija utemeljeno menila, da so sporni sporazumi v veliki večini primerov vsebovali omejitve onkraj obsega patentov družbe Lundbeck (glej šesti tožbeni razlog). | 801 | The fact that certain restrictions contained in the agreements at issue may have fallen within the scope of Lundbeck’s patents (as defined in paragraphs 335 and 569 above) is not such as to call into question that finding since it was only one factor among a number taken into account by the Commission in order to establish the existence of a restriction by object in the present case (paragraph 354 above). It is therefore irrelevant that they also contained restrictions falling within the scope of those patents, since, as the Commission correctly noted in the contested decision, the decisive factor is that, at the time when the agreements at issue were concluded, there was uncertainty as to whether or not the products that the generic undertakings intended to sell infringed any of Lundbeck’s patents, that their validity could have been called into question before a court, and that it was by means of a significant reverse payment that the applicants had acquired the certainty that the generic undertakings would not enter the market during the term of the agreements at issue (paragraphs 363 and 429 above). In any case, the Commission was right to consider that the agreements at issue contained, in the great majority of cases, restrictions going beyond the scope of Lundbeck’s patents (see sixth plea in law above). |
| 802 | Drugič, Komisija ni storila napake z mnenjem, da je imela družba Lundbeck zelo velik tržni delež proizvoda, na katerega se nanašajo zadevne kršitve na trgih, ki so jih prizadeli sporni sporazumi. Tako iz izpodbijanega sklepa vsaj posredno izhaja, da je imela družba Lundbeck ob sklenitvi spornih sporazumov monopol za citalopram, ker so njeni izvirni patenti za AFU citalopram ravno takrat potekli in ker nobeno podjetje, ki je tržilo generična zdravila, še ni vstopilo na trg. Komisija je v točki 215 obrazložitve izpodbijanega sklepa poleg tega ugotovila, da tudi če bi bil upoštevni trg večji in bi zajemal vsa zdravila proti depresiji, bi imela družba Lundbeck v večini držav članic EGP na tem trgu znaten tržni delež. | 802 | Secondly, the Commission did not err in taking the view that Lundbeck held a very large share of the market of the product concerned by the infringements in question in the geographical markets affected by the agreements at issue. Indeed, it is apparent, at least implicitly, from the contested decision that Lundbeck had a monopoly in respect of citalopram at the time of concluding the agreements at issue, since its original patents concerning the citalopram API had just expired and no undertaking selling generics had yet entered the market. Furthermore, even if the relevant market had been larger and had included all antidepressant medicinal products, the Commission noted, in recital 215 of the contested decision, that Lundbeck held a significant share of that market in most EEA countries. |
| 803 | Tretjič, Komisija je pravilno menila, da je bil geografski obseg zadevnih kršitev zelo velik, ker so vse razen kršitve s podjetjem Arrow zajemale celoten EGP. | 803 | Thirdly, the Commission was right to consider that the infringements in question had a wide geographic scope, since, with the exception of the infringement with Arrow, they all covered the whole of the EEA. |
| 804 | Komisiji v nasprotju z zatrjevanjem tožečih strank v zvezi s tem ni bilo treba znižati osnovnega zneska globe tako, da bi upoštevala samo vrednosti prodaje v državah, v katerih so bila generična podjetja najdlje s pripravami za vstop na trg. Komisija se je namreč, ker je šlo za kršitve zaradi cilja, ker se je geografski obseg spornih sporazumov (razen sporazumov s podjetjem Arrow) raztezal na celoten EGP, pravilno oprla na ta geografski obseg, ne da bi podrobneje analizirala konkretne možnosti generičnih podjetij za vstop v vsako državo članico EGP. Stranke spornih sporazumov so bile namreč tiste, ki so opredelile geografski obseg teh sporazumov in torej zadevne kršitve v obravnavani zadevi s tem, da so določile, da ta zajema celoten EGP (razen sporazumov s podjetjem Arrow). | 804 | Contrary to the applicants’ claim in that regard, the Commission was not required to reduce the basic amount of the fine in order to take into account only the value of sales in the countries where the generic undertakings were at a more advanced stage in their preparations for entering the market. As they were infringements by object, the Commission was entitled, in so far as the infringements constituted by the agreements at issue (with the exception of the agreements concluded with Arrow) had a geographic scope of the whole of the EEA, to rely on that geographic scope without carrying out a detailed examination of the specific entry prospects of generic undertakings in each EEA State. It is the parties to the agreements at issue who specified the geographic scope of those agreements, and accordingly of the infringements in question in the present case, by deciding to provide that they would cover the whole of the EEA (with the exception of the infringement with Arrow). |
| 805 | Četrtič, Komisija tudi ni storila napake z upoštevanjem dejstva, da so bili vsi sporni sporazumi izvršeni, česar sicer tožeči stranki ne izpodbijata, ker generična podjetja med trajanjem spornih sporazumov niso vstopila na trg, razen podjetje Merck (GUK) pred drugim podaljšanjem sporazuma GUK za Združeno kraljestvo (točke 28, 131 in 399 zgoraj). | 805 | Nor, fourthly, did the Commission err in taking into account the fact that all the agreements at issue had been implemented, which the applicants do not dispute, because the generic undertakings did not enter the market during the term of the agreements at issue, with the exception of Merck (GUK) before the second extension of the GUK United Kingdom agreement (paragraphs 28, 131 and 399 above). |
| 806 | Zato je treba na podlagi navedeni preudarkov razsoditi, da Komisija ni napačno uporabila prava z določitvijo deleža vrednosti prodaje, ki se upošteva pri izračunu osnovnega zneska globe za družbo Lundbeck, v višini 11 % oziroma 10 %, ker je bil geografski obseg sporazumov, ki jih je zajemala kršitev, celoten EGP. Poleg tega navedenih stopenj teže kršitve, ki so v spodnjem delu razpona iz točke 21 smernic iz leta 2006, na podlagi navedenih dejavnikov ni mogoče obravnavati kot nesorazmerne. | 806 | Accordingly, in the light of all those circumstances, it must be held that, in setting the proportion of the value of sales to be taken into account in order to determine the basic amount of the fine imposed on Lundbeck at 11% or 10% depending on whether or not the geographic scope of the agreements to which the infringement relates was the whole of the EEA, the Commission did not err in law. Moreover, in the light of the foregoing, such rates of gravity, which are at the lower end of the scale provided for in point 21 of the 2006 Guidelines, cannot be considered to be disproportionate. |
| 807 | Tožeči stranki ne moreta uspeti niti s trditvijo, da bi morala Komisija zaradi nezaupnosti sporazumov pri izračunu zneska globe, ki jima jo je naložila, določiti nižjo stopnjo teže kršitev. | 807 | The applicant also claims in vain that the lack of secrecy in respect of the agreements justified the Commission’s establishing a lower level of gravity when setting the amount of the fine imposed on them. |
| 808 | Točka 23 smernic iz leta 2006 namreč določa, da „[h]orizontalni sporazumi o določitvi cen, razdelitvi trgov in omejitvi proizvodnje, ki so načeloma tajni, zaradi svoje narave štejejo za najresnejše kršitve konkurence. Z vidika politike konkurence jih je treba preganjati z visokimi globami. Posledično bo upoštevani delež prodaje pri takih kršitvah na splošno v zgornjem delu omenjenega razpona“. | 808 | Point 23 of the 2006 Guidelines provides that ‘horizontal price-fixing, market-sharing and output-limitation agreements, which are usually secret, are, by their very nature, among the most harmful restrictions of competition’, that ‘[a]s a matter of policy, they will be heavily fined’ and that, ‘[t]herefore, the proportion of the value of sales taken into account for such infringements will generally be set at the higher end of the scale’. |
| 809 | Zadostuje pa ugotovitev, da se Komisija, tudi če sporni sporazumi niso bili tajni, z določitvijo deleža upoštevne prodaje v višini 10 % oziroma 11 % v obravnavani zadevi ni postavila v zgornji del razpona iz točke 21 navedenih smernic, to je 30 % vrednosti prodaje. | 809 | It suffices to note that, even if the agreements at issue were not secret, by setting the proportion of sales taken into account at 10% and 11% respectively in the present case, the Commission was not at the top of the scale set out in point 21 of the Guidelines, which is set at 30% of the value of sales. |
| 810 | Poleg tega je treba opozoriti, da je Komisija v nekaterih primerih iz različnih razlogov sicer lahko menila, da ni bilo treba naložiti globe ali upoštevati vrednosti prodaje v najnižjem delu razpona stopnje teže kršitev, vendar v skladu z ustaljeno sodno prakso predhodna upravna praksa Komisije ni pravni okvir za globe na področju konkurence, glede na to, da je ta opredeljen le v Uredbi št. 1/2003 in smernicah. Tako so odločbe v drugih zadevah le informativne narave glede morebitnega obstoja diskriminacije, ker je malo verjetno, da so okoliščine v teh zadevah, kot so trgi, proizvodi, podjetja in zadevna obdobja, enake (glej v tem smislu zgoraj v točki 98 navedeno sodbo E.ON Ruhrgas in E.ON/Komisija, EU:T:2012:332, točke od 260 do 262 in navedena sodna praksa). V obravnavani zadevi pa okoliščine zadev v prejšnjih odločbah, ki ju navajata tožeči stranki, kot so trgi, proizvodi, države, podjetja in zadevna obdobja, niso primerljive s tistimi v obravnavanem primeru, tako da navedene odločbe niso upoštevne glede spoštovanja načela enakega obravnavanja v skladu z navedeno sodno prakso. | 810 | In addition, while the Commission has been able, in some cases, to consider that it was not necessary to impose a fine or to take into consideration a proportion of the value of sales at the lower end of the scale of gravity, for various reasons, it must be recalled that, according to settled case-law, the Commission’s earlier decision-making practice does not in itself serve as a legal framework for the imposition of fines in competition matters, since that framework is defined solely in Regulation No 1/2003 and in the Guidelines. Consequently, decisions in other cases can give only an indication for the purpose of determining whether there might be discrimination, since the facts of those cases, such as markets, products, the undertakings and periods concerned, are not likely to be the same (see, to that effect, judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 98 above, EU:T:2012:332, paragraphs 260 to 262 and the case-law cited). In the present case, the facts of the case in the previous decisions relied on by the applicants, such as the markets, goods, countries, undertakings and periods in question, are not comparable to those of the present case, with the result that those decisions are not relevant from the point of view of observance of the principle of equal treatment, in accordance with the case-law cited above. |
| 811 | Nazadnje, tožeči stranki napačno zatrjujeta kršitev načela sorazmernosti v obravnavani zadevi. Načelo sorazmernosti namreč v teh okoliščinah pomeni samo to, da mora Komisija določiti globo sorazmerno z dejavniki, ki se upoštevajo pri določitvi teže kršitve, in da mora te dejavnike upoštevati skladno in objektivno upravičeno (glej sodbo z dne 27. septembra 2006, Jungbunzlauer/Komisija, T‑43/02, ZOdl., EU:T:2006:270, točka 228 in navedena sodna praksa). Iz točk od 1330 do 1333 obrazložitve izpodbijanega sklepa pa izhaja, da je Komisija načela iz točke 22 smernic iz leta 2006 v obravnavani zadevi uporabila skladno in objektivno upravičeno. | 811 | Finally the applicants are wrong to allege infringement of the principle of proportionality in the present case. In this context, that principle requires only that the Commission set the fine proportionately to the factors taken into account for the purposes of assessing the gravity of the infringement and that it must apply those factors in a way which is consistent and objectively justified (see judgment of 27 September 2006 in Jungbunzlauer v Commission, T‑43/02, ECR, EU:T:2006:270, paragraph 228 and the case-law cited). It is clear from recitals 1330 to 1333 of the contested decision that the Commission applied the principles set out in point 22 of the 2006 Guidelines in a manner which is consistent and objectively justified in the present case. |
| 812 | Prvi del je torej treba zavrniti. | 812 | The first part must therefore be rejected. |
| B – Drugi del | B – The second part |
| 813 | Tožeči stranki trdita, da v točki 1335 obrazložitve izpodbijanega sklepa napačno ni bilo sprejeto, da so zatrjevane kršitve trajale manj časa. To trajanje bi moralo biti omejeno na čas, v katerem so bila generična podjetja dejansko pripravljena za vstop na trg, za kar bi potrebovala vsaj eno DZP v upoštevnih državah. V Avstriji pa je na primer patent za AFU potekel šele aprila 2003, zato kršitve, storjene s podjetji Merck (GUK), Alpharma in Ranbaxy, pred tem datumom niso mogle omejevati konkurence v Avstriji. Ta pristop naj bi bil podoben stališču Komisije iz odločbe C(2009) 5355 final z dne 8. julija 2009 v zvezi s postopkom na podlagi člena 81 [ES] (zadeva COMP/39.401 – E.ON/GDF) (povzetek v UL C 248, str. 5, v nadaljevanju: odločba E.ON/GDF), v kateri je bilo pri izračunu zneska globe upoštevano samo obdobje po letu 1998. | 813 | The applicants claim that the contested decision was wrong, in recital 1335, to refuse to accept that the alleged infringements were of shorter duration. The duration should be limited to the period during which the generic undertakings were actually ready to enter the market, which means that they must have had at least one MA in the relevant countries. In Austria, for example, the API patent did not expire until April 2003 and the infringements committed with GUK, Alpharma and Ranbaxy cannot therefore have restricted competition in Austria before that date. That approach is similar to the position taken by the Commission in Decision C(2009) 5355 final of 8 July 2009 relating to a proceeding under Article [101 TFEU] (Case COMP/39.401 — E.ON/GDF) (summary published in OJ 2009 C 248, p. 5; the ‘E.ON/GDF decision’), where only the period after 1998 was taken into consideration for the purposes of calculating the amount of the fine. |
| 814 | Komisija te trditve zavrača. | 814 | The Commission disputes those arguments. |
| 815 | V zvezi s tem je treba tako kot Komisija ugotoviti, da ta trditev pomeni zanikanje razlike med dejansko in potencialno konkurenco ter to, da člen 101 PDEU varuje tudi zadnjenavedeno (točka 99 zgoraj). Komisija pa je za vsa generična podjetja zadostno dokazala, da so imela dejanske in konkretne možnosti vstopa na trg, in da so bila torej potencialni konkurenti družbe Lundbeck v času sklenitve spornih sporazumov (glej prvi tožbeni razlog zgoraj). | 815 | In that respect, it must be noted, as the Commission states, that such an argument amounts to denying the distinction between actual competition and potential competition, and the fact that Article 101 TFEU also protects the latter (paragraph 99 above). The Commission has sufficiently established, for all the generic undertakings concerned, that they had real concrete possibilities of entering the market and that they were therefore potential competitors of Lundbeck at the time of conclusion of the agreements at issue (see the first plea in law above). |
| 816 | Zadeva, v kateri je bila izdana zgoraj v točki 98 navedena sodba E.ON Ruhrgas in E.ON/Komisija (EU:T:2012:332) tožečima strankama ni v nobeno pomoč, saj v navedeni zadevi – kot sami priznavata – kakršna koli konkurenca ni bila mogoča tudi brez protikonkurenčnega sporazuma za določen del obdobja kršitve, ker na trgu ni bilo konkurence zaradi nacionalne zakonodaje v navedenem obdobju, kar je ustvarilo dejanski monopol. Iz tega razloga je Splošno sodišče tudi delno razveljavilo odločbo Komisije v navedeni zadevi, ker obstoj omejitve konkurence na nemškem plinskem trgu v tem obdobju ni bil zadostno dokazan (zgoraj v točki 98 navedena sodba E.ON Ruhrgas in E.ON/Komisija, EU:T:2012:332, točki 105 in 155). V obravnavani zadevi pa je Komisija, nasprotno, zadostno pravno dokazala, da je bila konkurenca zaradi spornih sporazumov omejena ves čas njihovega trajanja. Tožeči stranki nista dokazali, da konkurenca – tudi potencialna – brez spornih sporazumov med njima in generičnimi podjetji ne bi bila mogoča ali obstoječa, niti da ti sporazumi sploh niso omejevali konkurence. | 816 | The case that gave rise to the judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 98 above (EU:T:2012:332), is of no assistance to the applicants, since in that case, as the applicants recognise, no competition was possible, even in the absence of the anticompetitive agreement for part of the infringement period, since the market was legally shielded against any competition by virtue of the national legislation applicable during that period, which created a de facto monopoly. It is moreover for that reason that the Commission decision was partially annulled by the Court, in so far as the existence of a restriction of competition on the German gas market was not sufficiently established during that period (judgment in E.ON Ruhrgas and E.ON v Commission, paragraph 98 above, EU:T:2012:332, paragraphs 105 and 155). In the present case, by contrast, the Commission established to the requisite legal standard in the contested decision that competition had been restricted by virtue of the agreements at issue, during their entire term. The applicants have failed to demonstrate that, in the absence of the agreements at issue, competition — even potential — between them and the generic undertakings would have been impossible or non-existent or that those agreements placed no restriction on competition. |
| 817 | Zato je treba drugi del zavrniti. | 817 | The second part must therefore be rejected. |
| C – Tretji del | C – The third part |
| 818 | Tožeči stranki menita, da jima ne bi smel biti naložen noben dodatni znesek, celo za sporazume s podjetjem Arrow (glej točko 73 zgoraj), ker zatrjevane kršitve ne ustrezajo nobenemu primeru, v katerem smernice iz leta 2006 priporočajo uporabo dodatnega zneska (to pa so „horizontalni sporazumi o določitvi cen, razdelitvi trga in omejitvi proizvodnje“), in ker naj ne bi bil potreben noben večji odvračilni učinek v zvezi s kršitvami, ki so se začele pred več kot desetimi leti in se niso ponovile. | 818 | The applicants maintain that no additional amount ought to have been imposed on them, not even for the agreements concluded with Arrow (see paragraph 73 above), since the alleged infringements do not correspond to any of the examples for which the 2006 Guidelines recommend the application of an additional amount (those cases being ‘horizontal price-fixing, market-sharing and output limitation agreements’) and since no increased deterrent effect is necessary in the case of infringements which began more than 10 years ago and have not been repeated. |
| 819 | Komisija te trditve zavrača. | 819 | The Commission disputes those arguments. |
| 820 | Najprej je treba spomniti, da točka 25 smernic iz leta 2006, ki določa vključitev vstopne pristojbine v osnovni znesek globe, določa, da: | „[…] bo Komisija, ne glede na trajanje udeležbe podjetja pri kršitvi, vključila v osnovni znesek še znesek med vključno 15 % in 25 % vrednosti prodaje, […] z namenom odvračanja podjetij od udeležbe pri horizontalnih sporazumih o določitvi cen, razdelitvi trga in omejitvi proizvodnje. Komisija lahko tako povečanje zneska uporabi tudi v primeru drugih kršitev. Pri odločitvi, kolikšen delež vrednosti prodaje naj se upošteva v posameznem primeru, bo Komisija upoštevala več dejavnikov, zlasti tiste iz točke 22 [kot so narava kršitve, skupni tržni delež vseh zadevnih podjetij, geografski obseg kršitve in dejstvo, ali je bila kršitev izvršena ali ne].“ | 820 | First, it must be noted that point 25 of the 2006 Guidelines, which provides for the inclusion of an entry fee in the basic amount of the fine, states as follows: | ‘Irrespective of the duration of the undertaking’s participation in the infringement, the Commission will include in the basic amount a sum of between 15% and 25% of the value of sales …, in order to deter undertakings from even entering into horizontal price-fixing, market-sharing and output-limitation agreements. The Commission may also apply such an additional amount in the case of other infringements. For the purpose of deciding the proportion of the value of sales to be considered in a given case, the Commission will have regard to a number of factors, in particular those referred in point 22 [namely, the nature of the infringement, the combined market share of all the undertakings concerned, the geographic scope of the infringement and whether or not the infringement has been implemented].’ |
| 821 | Tožeči stranki v bistvu trdita, da Komisija take vstopne pristojbine zaradi odvračilnosti ne sme vključiti v globo, ki jima je bila naložena, ker zatrjevane kršitve ne ustrezajo nobenemu primeru, v katerem Smernice iz leta 2006 priporočajo uporabo dodatnega zneska, in ker naj se kršitve, ki so se zgodile pred več kot desetimi leti, ne bi ponovile. | 821 | The applicants claim, in essence, that the Commission could not include such an entry fee in the fine imposed on them, as a deterrent, since the alleged infringements did not correspond to any example for which the 2006 Guidelines recommend the application of an additional amount, and in so far as the infringements, which began more than 10 years ago, have not been repeated. |
| 822 | Vendar je treba opozoriti na to, da nadzorna naloga, ki jo Komisiji daje pravo Unije, na področju prava konkurence zajema dolžnost preiskovanja in sankcioniranja posameznih kršitev in dolžnost izvajanja splošne politike, katere namen je, da se na področju konkurence uporabljajo načela, ki jih določa Pogodba, in da se v to usmeri delovanje podjetij. Iz tega sledi, da mora Komisija zagotoviti odvračilnost glob (glej v tem smislu sodbo z dne 17. decembra 2014, Pilkington Group in drugi/Komisija, T‑72/09, EU:T:2014:1094, točka 302 in navedena sodna praksa). | 822 | However, it must be noted that the task of supervision conferred upon the Commission by EU law in the field of competition law includes the duty to investigate and punish individual infringements, as well as the duty to pursue a general policy designed to apply, in competition matters, the principles laid down by the Treaty and to guide the conduct of undertakings in the light of those principles. It follows that the Commission must ensure that fines have a deterrent effect (see, to that effect, judgment of 17 December 2014 in Pilkington Group and Others v Commission, T‑72/09, EU:T:2014:1094, paragraph 302 and the case-law cited). |
| 823 | Zato namen odvračilnega učinka globe ni zgolj odvrniti zadevno podjetje od ponovitve kršitve. Komisija lahko določi višino glob zaradi okrepitve njihovega splošnega odvračilnega učinka, zlasti kadar so določene vrste kršitev sorazmerno pogoste ali se obravnavajo kot resne (glej zgoraj v točki 822 navedeno sodbo Pilkington Group in drugi/Komisija, EU:T:2014:1094, točka 303 in navedena sodna praksa). | 823 | Accordingly, the deterrent effect of the fine is not designed solely to deter the undertaking in question from repeating the infringement. The Commission has the power to determine the level of fines with a view to reinforcing their deterrent effect in general, especially where infringements of a given type are still relatively frequent or are regarded as serious (see judgment in Pilkington Group and Others v Commission, cited in paragraph 822 above, EU:T:2014:1094, paragraph 303 and the case-law cited). |
| 824 | Poleg tega so sporni sporazumi v obravnavani zadevi, kot je navedla Komisija, zelo podobni sporazumom o razdelitvi trga ali omejitvi proizvodnje, ki so izrecno omenjeni v točki 25 smernic (točka 820 zgoraj). Vsekakor pa je Komisija v navedeni točki teh smernic v skladu s sodno prakso pooblaščena, da določi tak dodatni znesek zaradi zagotovitve odvračilnosti globe za druge vrste kršitev. | 824 | Furthermore, as the Commission states, in the present case the agreements at issue were strongly akin to market-sharing or output-limitation agreements, which are explicitly referred to in point 25 of the 2006 Guidelines (point 820 above). In any event, that point of those Guidelines authorises the Commission, in accordance with the case-law, to apply such an additional amount in order to ensure that the fine has deterrent effect in respect of other types of infringements. |
| 825 | Zato je treba skleniti, da Komisija ni prekoračila diskrecijske pravice v zvezi z globami niti ni kršila smernic iz leta 2006, ko je zaradi zagotovitve zadostne odvračilnosti globe za tožeči stranki določila dodatni znesek v višini 10 % vrednosti letne prodaje za prvo kršitev s podjetjem Arrow (točka 1340 obrazložitve izpodbijanega sklepa). | 825 | It must therefore be concluded that the Commission did not exceed its discretion in respect of fines or infringe its 2006 Guidelines by applying an additional amount of 10% of the value of annual sales for the first infringement committed with Arrow in order to ensure that the fine imposed on the applicants had a sufficient deterrent effect (recital 1340 of the contested decision). |
| 826 | Zato je treba tudi tretji del zavrniti. | 826 | Accordingly, the third part must also be rejected. |
| D – Četrti del | D – The fourth part |
| 827 | Na prvem mestu, tožeči stranki menita, da Komisija družbi Lundbeck napačno ni priznala olajševalnih okoliščin, ker je podjetje razumno dvomilo v to, da je omejevalno ravnanje kršitev. Utemeljitev v izpodbijanem sklepu, da olajševalne okoliščine zaradi razumnega dvoma v obstoj kršitve ni več v smernicah iz leta 2006 (točka 1343 obrazložitve izpodbijanega sklepa), ni upošteven razlog za to, da se ne upošteva, ker naj bi tako smernice kot Splošno sodišče priznavala, da seznam olajševalnih okoliščin ni izčrpen. Poleg tega naj bi iz korespondence med KFST in Komisijo jasno izhajalo stališče zadnjenavedene, da pravni standard v tistem času ni bil jasen, zato ni mogel biti niti družbi Lundbeck. | 827 | The applicants maintain, first, that the Commission was wrong to refuse to grant Lundbeck the benefit of a mitigating circumstance on the basis of the existence of reasonable doubt on the part of the undertaking as to whether the restrictive conduct did indeed constitute an infringement. The argument in the contested decision that the mitigating circumstance based on reasonable doubt as to the existence of an infringement no longer appeared in the 2006 Guidelines (recital 1343 of the contested decision) is not a valid reason for not applying it, since both those Guidelines and the Court acknowledge that the list of mitigating circumstances is not exhaustive. In addition, the applicants argue that it is clear from the communications between KFST and the Commission that, in the Commission’s view, the legal standard was not clear at the time and cannot therefore have been clear to Lundbeck either. |
| 828 | Na drugem mestu, tožeči stranki trdita, da jima neutemeljeno ni bila priznana olajševalna okoliščina, ker so bile zatrjevane kršitve storjene iz malomarnosti, saj sta sporne sporazume skleniti v dobri veri, da bi generičnim podjetjem preprečili kršitev njunih patentov s tem, da sta omejili področje uporabe teh sporazumov samo na ponarejene proizvode in jih nista nikoli poskušali skrivati, kar bi počeli, če bi nameravali kršiti pravo konkurence EU. | 828 | In the second place, the applicants claim that they were unjustly deprived of the benefit of the mitigating circumstance that the alleged infringements were committed as a result of negligence, whereas they had concluded the agreements at issue in good faith in order to prevent the infringement of their patents by the generic undertakings, restricting the scope of the agreements solely to products infringing those patents and making no attempt to keep the agreements secret, as they would have done had they intended to infringe European Union competition law. |
| 829 | Komisija te trditve zavrača. | 829 | The Commission disputes those arguments. |
| 830 | Na prvem mestu, tako kot tožeči stranki je treba ugotoviti, da to, da obstoja razumnega dvoma v obstoj kršitve izrecno ni med izrecno navedenimi olajševalnimi okoliščinami v smernicah iz leta 2006, ne zadostuje za to, da ga Komisija samodejno ne upošteva kot olajševalno okoliščino. V sodni praksi je bilo namreč v zvezi s tem pojasnjeno, da smernice olajševalnih okoliščin, ki se lahko upoštevajo, ne določajo kot obveznih, zato si je Komisija pri splošni presoji pomena morebitnega zmanjšanja zneska glob na podlagi olajševalnih okoliščin pridržala določen prostor za prosto presojo (glej v tem smislu zgoraj v točki 380 navedeno sodbo z dne 8. julija 2004, Dalmine/Komisija, EU:T:2004:220, točka 326 in navedena sodna praksa). | 830 | In the first place, it must be noted, as the applicants observe, that the fact that the existence of reasonable doubt as to the existence of an infringement does not appear explicitly among the mitigating circumstances explicitly referred to in the 2006 Guidelines does not suffice for the Commission automatically to reject its application as a mitigating circumstance. Case-law specifies in that regard that in the absence of a mandatory indication in the Guidelines of the mitigating circumstances which may be taken into account, it must be held that the Commission retained a certain discretion in its global assessment of the size of any reduction in the fines to reflect mitigating circumstances (see, to that effect, judgment of 8 July 2004 in Dalmine v Commission, cited in paragraph 380 above, EU:T:2004:220, paragraph 326 and the case-law cited). |
| 831 | Vendar to, da določena odločba Komisije pomeni prvi primer uporabe pravil o konkurenci v zadevnem gospodarskem sektorju, ni mogoče opredeliti kot olajševalno okoliščino, če je kršitelj vedel ali bi moral vedeti, da bi lahko njegovo ravnanje povzročilo omejitev konkurence na trgu in težave z vidika prava konkurence (sodba z dne 8. marca 2011, World Wide Tobacco España/Komisija, T‑37/05, EU:T:2011:76, točka 160). | 831 | However, the fact that a Commission decision is the first application of the competition rules to a particular sector of the economy cannot be regarded as a mitigating factor if the perpetrator of the infringement knew or could not have been unaware that its conduct could lead to a restriction of competition on the market and pose problems with regard to competition law (see, to that effect, judgment of 8 March 2011 in World Wide Tobacco España v Commission, T‑37/05, EU:T:2011:76, paragraph 160). |
| 832 | V obravnavani zadevi pa bi tožeči stranki morali vedeti, da bi sporni sporazumi lahko kršili člen 101 PDEU. Ti sporazumi so bili namreč namenjeni izključitvi potencialnih konkurentov s trga med njihovim trajanjem, kar so resne kršitve, izrecno navedene v členu 101(1) PDEU. | 832 | In the present case, the applicants could not have been unaware that the agreements at issue were capable of infringing Article 101 TFEU. The agreements at issue intended to exclude potential competitors from the market during their terms, against payment, which falls within the scope of the serious infringements referred to explicitly in Article 101(1) TFEU. |
| 833 | Poleg tega iz izpodbijanega sklepa izhaja, da se je družba Lundbeck zavedala tega, da so sporni sporazumi potencialne kršitve (glej točko 776 zgoraj). | 833 | Furthermore, it is clear from the contested decision that Lundbeck was aware of the potentially infringing nature of those agreements (see paragraph 776 above). |
| 834 | Sicer pa je treba v zvezi s sporočili za javnost KFST, na katera se opirata tožeči stranki, opozoriti na to, da se podjetje, ki je kršilo člen 101 PDEU, ne more izogniti naložitvi globe, če je do kršitve prišlo, ker je bilo v zmoti glede zakonitosti svojega ravnanja zaradi pravnega nasveta odvetnika ali odločitve nacionalnega organa, pristojnega za konkurenco (zgoraj v točki 747 navedena sodba Schenker & Co. in drugi, EU:C:2013:404, točka 43). Poleg tega je bilo v obravnavani zadevi v teh sporočilih – ne glede na to, ali so izkazovala dvom v uporabljivost člena 101 PDEU za sporne sporazume – pojasnjeno, da bi sporni sporazumi lahko vplivali na konkurenco, če bi se izkazalo, da je družba Lundbeck plačala konkurentom za to, da ostanejo zunaj trga. | 834 | Moreover, as regards the KFST press releases relied on by the applicants, it must be noted that an undertaking which has infringed Article 101 TFEU may not escape imposition of a fine where the infringement has resulted from that undertaking erring as to the lawfulness of its conduct on account of the legal advice given by a lawyer or of the terms of a decision of a national competition authority (see judgment in Schenker & Co. and Others, cited in paragraph 748 above, EU:C:2013:404, paragraph 43). Furthermore, in the present case, far from raising doubts as to the applicability of Article 101 TFEU to the agreements at issue, those press releases specified that the agreements at issue could influence competition if it appeared that Lundbeck had paid competitors to stay out of the market. |
| 835 | Vsekakor pa takrat v okoliščinah, v katerih sta tožeči stranki razpolagali s patentiranimi postopki, na podlagi katerih bi lahko nasprotovali vstopu generičnih podjetij na trg – tudi če bi v času sklenitve spornih sporazumov lahko obstajal razumen dvom v dejavnike, ki jih je treba upoštevati pri ugotavljanju obstoja omejitve konkurence zaradi cilja v obravnavani zadevi – kljub vsemu ni moglo biti dvoma v to, da sporazumi, katerih cilj je bil tako kot v obravnavani zadevi plačilo potencialnim konkurentom za to, da za določen čas ostanejo zunaj trga, niso mogli biti v skladu s členom 101(1) PDEU, ker nikakor niso omogočali olajšanega vstopa generikov na trg, niti po njihovem poteku, in ker v resnici niso omogočali rešitve osnovnih patentnih sporov med strankami (točki 475 in 497 zgoraj). | 835 | In any event, even if reasonable doubt could have existed, at the time of concluding the agreements at issue, with regard to the factors to be taken into account for the purposes of establishing the existence of a restriction of competition by object in the present case, in a context where the applicants held process patents capable of preventing the entry of generic undertakings to the market, it is nevertheless the case that there could be no doubt, at that time, that agreements under which, as in the present case, potential competitors were to be paid to stay out of the market for a specified period could not comply with Article 101(1) TFEU, since they did not permit the entry of generics to the market to be facilitated in any way, including after their expiry, and they did not in fact allow the underlying patent dispute to be resolved between the parties (paragraphs 475 and 497 above). |
| 836 | Poleg tega so sporni sporazumi, razen sporazuma GUK za Združeno kraljestvo – kot je bilo ugotovljeno pri šestem tožbenem razlogu zgoraj – vsebovali omejitve onkraj obsega patentov družbe Lundbeck, zato tudi če bi bil preizkus obsega patentov, ki sta ga predlagali tožeči stranki, upošteven preizkus za presojo zakonitosti teh sporazumov na podlagi člena 101(1) PDEU, ti sporazumi ne bi prestali tega preizkusa in bi torej pomenili omejitve konkurence zaradi cilja v smislu navedene določbe. V zvezi s sporazumom GUK za Združeno kraljestvo je treba ugotoviti, da je ta skupaj s sporazumom GUK za EGP del enotne in nadaljevane kršitve družbe Lundbeck in podjetja Merck (GUK). Kot je bilo navedeno zgoraj, pa je Komisija zadostno dokazala, da je sporazum GUK za EGP vseboval omejitve onkraj obsega patentov družbe Lundbeck. | 836 | Furthermore, as established in the context of the sixth plea in law above, the agreements at issue, with the exception of the GUK United Kingdom agreement, contained restrictions going beyond the scope of Lundbeck’s patents, with the result that, even if the criterion of the scope of the patents, put forward by the applicants, had been the relevant legal criterion for assessing the legality of those agreements with regard to Article 101(1) TFEU, the agreements at issue would not have fulfilled that criterion and would therefore have constituted restrictions of competition by object within the meaning of that provision. As regards the GUK United Kingdom agreement, it must be noted that it forms part, with the EEA GUK agreements, of the same single and continuous infringement committed by Lundbeck and Merck (GUK). As stated above, the Commission has sufficiently established that the EEA GUK agreement contained restrictions going beyond the scope of Lundbeck’s patents. |
| 837 | Na drugem mestu, tožeči stranki trdita, da so bile zadevne kršitve v obravnavani zadevi storjene iz malomarnosti, kar naj bi bila tudi olajševalna okoliščina, ki upravičuje zmanjšanje globe. | 837 | In the second place, the applicants claim that the infringements at issue in the present case were committed as a result of negligence, which also constitutes a mitigating circumstance justifying a reduction of the fine. |
| 838 | V točki 29 smernic iz leta 2006 je pojasnjeno, da se osnovni znesek globe lahko zmanjša, kadar Komisija ugotovi, da obstajajo olajševalne okoliščine, kot na primer, kadar zadevno podjetje dokaže, da je bila kršitev storjena iz malomarnosti. | 838 | Point 29 of the 2006 Guidelines provides that the basic amount of the fine may be reduced where the Commission finds that mitigating circumstances exist, inter alia, for example, where the undertaking provides evidence that the infringement has been committed as a result of negligence. |
| 839 | V obravnavani zadevi pa je treba ugotoviti, da sta tožeči stranki sporne sporazume sklenili namerno in da je bil to del zavestne strategije za preprečevanje potencialnega takojšnjega vstopa generikov na trg (točki 126 in 528 zgoraj). | 839 | In the present case, however, it must be noted that the agreements at issue were concluded by the applicants intentionally and that they were part of a deliberate strategy to prevent the potentially immediate entry of generics to the market (paragraphs 126 and 528 above). |
| 840 | Trditev tožečih strank namreč ponovno temelji na premisi, da so sporni sporazumi preprečevali dostop do trga samo tistim generičnim proizvodom, s katerimi so bili potencialno kršeni njuni patenti. Kot je bilo prikazano zgoraj pri obravnavi šestega tožbenega razloga, pa ni tako. Vsekakor pa je obstajala negotovost glede tega, ali so patenti družbe Lundbeck veljavni in ali so bili kršeni s proizvodi, ki so jih generična podjetja nameravala tržiti v času sklenitve spornih sporazumov (glej drugi tožbeni razlog zgoraj), ki pa je bila s temi sporazumi odpravljena. Tožeči stranki zato napačno trdita, da so bile kršitve v obravnavani zadevi storjene iz malomarnosti in da bi jima morala Komisija priznati to olajševalno okoliščino. | 840 | The applicants’ argument again relies on the premiss that the agreements at issue only prevented access to the market of generic products which potentially infringed their patents. As demonstrated in the context of the sixth plea in law above, this is not the case. In any event, there was uncertainty as to whether Lundbeck’s patents were valid and whether they were infringed by the products that the generic undertakings had intended to sell at the time of conclusion of the agreements at issue (see the second plea in law above), uncertainty which was removed by those agreements. The applicants therefore wrongly claimed that the infringements were committed as a result of negligence in the present case and that the Commission should have granted them the benefit of that mitigating circumstance. |
| 841 | Poleg tega Komisija, tudi če bi bile kršitve storjene iz malomarnosti, kljub temu ni bila zavezana, da tožečima strankama prizna zmanjšanje globe. Kot namreč potrjuje besedilo točke 29 smernic iz leta 2006, ima Komisija v zvezi s tem diskrecijsko pravico, ob upoštevanju vseh okoliščin zadeve. Zato Komisija, čeprav so v smernicah navedene okoliščine gotovo med tistimi, ki jih Komisija lahko upošteva v določeni zadevi, ni zavezana – kadar podjetje predloži dokaze, ki kažejo na prisotnost takih okoliščin – da samodejno prizna dodatno zmanjšanje, brez celovite analize. Primernost morebitnega zmanjšanja globe zaradi olajševalnih okoliščin je namreč treba presojati celovito, ob upoštevanju vseh upoštevnih okoliščin zadeve (glej v tem smislu sodbo z dne 5. decembra 2013, Caffaro/Komisija, C‑447/11 P, EU:C:2013:797, točka 103). | 841 | Furthermore, even if the infringements had been committed as a result of negligence in the present case, the Commission was not required to grant a reduction in the fine to the applicants. As the wording of point 29 of the 2006 Guidelines confirms, the Commission has a discretion in that regard, taking account of all the circumstances of the case. Accordingly, although the circumstances set out in the Guidelines are certainly among those which may be taken into account by the Commission in a specific case, it is not required, where an undertaking puts forward evidence capable of indicating the presence of one of those circumstances, to grant a further reduction as a matter of course without performing an overall analysis. The appropriateness of any reduction in the fine in respect of mitigating circumstances must be examined comprehensively on the basis of all the relevant circumstances (see, to that effect, judgment of 5 December 2013 in Caffaro v Commission, C‑447/11 P, EU:C:2013:797, paragraph 103). |
| 842 | Splošno sodišče na podlagi vseh okoliščin zadeve in še posebej tega, da je Komisija upoštevala trajanje postopka, na podlagi česar je priznala 10‑odstotno zmanjšanje osnovnega zneska globe, naložene tožečima strankama, ob izvrševanju svojega pooblastila za odločanje v okviru neomejene pristojnosti na podlagi člena 31 Uredbe št. 1/2003 v skladu s členom 261 PDEU (točka 793 zgoraj) meni, da v obravnavani zadevi ni mogoče priznati olajševalnih okoliščin in da je treba potrditi tožečima strankama naloženo globo iz izpodbijanega sklepa. | 842 | In the light of all of the circumstances of the case and the fact, in particular, that the Commission took into account the length of the procedure in granting a 10% reduction in the basic amount of the fine imposed on the applicants, the Court considers, exercising its unlimited jurisdiction conferred by Article 31 of Regulation No 1/2003 in accordance with Article 261 TFEU (paragraph 793 above), that it is not necessary to grant the benefit of mitigating circumstances in the present case, and that the fine imposed on the applicants in the contested decision must be upheld. |
| 843 | Kar zadeva, natančneje, sporazum GUK za Združeno kraljestvo, je treba izpostaviti, da je bilo pri obravnavi šestega tožbenega razloga sicer ugotovljeno, da Komisija v izpodbijanem sklepu ni zadostno dokazala, da je ta sporazum vseboval omejitve onkraj obsega patentov družbe Lundbeck, vendar pa je bilo razsojeno, da ta očitek ni upošteven iz razlogov v točkah 539 ter od 570 do 577 zgoraj. Zato Splošnemu sodišču ni treba priznati zmanjšanja zneska globe tožečima strankama v zvezi s tem. | 843 | As regards, in particular, the GUK United Kingdom agreement, it must be stressed that, although it was observed in the context of the sixth plea in law, that the Commission had not sufficiently established, in the contested decision, that that agreement contained restrictions going beyond the scope of Lundbeck’s patents, such a complaint was deemed ineffective, for the reasons set out in paragraphs 539 and 570 to 577 above. There is therefore no need for the Court to grant a reduction in the amount of the fine imposed on the applicants in that regard. |
| 844 | Zato je treba zavrniti četrti del in deseti tožbeni razlog v celoti. | 844 | Accordingly, the fourth part and the tenth plea in law in its entirety must be rejected. |
| 845 | Ker nobeden od tožbenih razlogov, na katere sta se v podporo svojemu predlogu za razglasitev ničnosti izpodbijanega sklepa opirali tožeči stranki, ni utemeljen ali upošteven, analiza utemeljitev v podporo njunemu predlogu za spremembo zneska globe pa ni razkrila nepravilnosti pri izračunu njenega zneska, ki ga je opravila Komisija, je treba tožbo v celoti zavrniti. | 845 | Since none of the pleas in law relied on by the applicants in support of their application for annulment of the contested decision is well founded or effective and since the examination of the arguments put forward in support of their application for reduction of the amount of the fine has not revealed inappropriate elements in the Commission’s calculation of the amount of that fine, the action must be dismissed in its entirety. |
| Stroški | Costs |
| 846 | V skladu s členom 134 Poslovnika se neuspeli stranki naloži plačilo stroškov, če so bili ti priglašeni. Ker tožeči stranki nista uspeli, se jima v skladu s predlogom Komisije naloži plačilo stroškov. | 846 | Under Article 134 of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicants have been unsuccessful, they must be ordered to pay the costs, in accordance with the form of order sought by the Commission. |
| 847 | V skladu s členom 138(3) Poslovnika in predlogom Komisije je treba intervenientu naložiti plačilo njegovih stroškov. | 847 | In accordance with Article 138(3) of the Rules of Procedure and the form of order sought by the Commission, the intervener must be ordered to bear its own costs. |
| | Iz teh razlogov je | SPLOŠNO SODIŠČE (deveti senat) | razsodilo: | | On those grounds, | THE GENERAL COURT (Ninth Chamber) | hereby: |
| | 1. | Tožba se zavrne. | | 1. | Dismisses the action; |
| | 2. | Družbi H. Lundbeck A/S in Lundbeck Ltd nosita poleg svojih tudi stroške Komisije. | | 2. | Orders H. Lundbeck A/S and Lundbeck Ltd to bear their own costs and to pay the European Commission’s costs; |
| | 3. | European Federation of Pharmaceutical Industries and Associations (EFPIA) nosi svoje stroške. | | 3. | Orders the European Federation of Pharmaceutical Industries and Associations (EFPIA) to bear its own costs. |
| | Berardis | Czúcz | Popescu | Razglašeno na javni obravnavi v Luxembourgu, 8. septembra 2016. | Podpisi | | Berardis | Czúcz | Popescu | Delivered in open court in Luxembourg on 8 September 2016. | [Signatures] |
| Kazalo | Table of contents |
| | Povzetek dejanskega stanja | | Summary of the facts and background to the dispute |
| | I – Družbe, obravnavane v tej zadevi | | I – The companies involved in the present case |
| | II – Zadevni proizvod in patenti v zvezi z njim | | II – The relevant product and the applicable patents |
| | III – Sporni sporazumi | | III – The agreements at issue |
| | A – Sporazuma s podjetjem Merck (GUK) | | A – The agreements with Merck (GUK) |
| | B – Sporazuma s podjetjem Arrow | | B – The agreements with Arrow |
| | C – Sporazum s podjetjem Alpharma | | C – The agreement with Alpharma |
| | D – Sporazum s podjetjem Ranbaxy | | D – The agreement with Ranbaxy |
| | IV – Ukrepanje Komisije v farmacevtskem sektorju in upravni postopek | | IV – Steps taken by the Commission in the pharmaceutical sector and administrative procedure |
| | V – Izpodbijani sklep | | V – Contested decision |
| | Postopek in predlogi strank | | Procedure and forms of order sought |
| | Pravo | | Law |
| | I – Prvi tožbeni razlog: napačna uporaba prava in presoja, ker se v izpodbijanem sklepu ugotavlja, da so bila generična podjetja in družba Lundbeck v času sklenitve spornih sporazumov vsaj potencialni konkurenti | | I – The first plea in law, alleging errors of law and of assessment in that the contested decision considered that the generic undertakings and Lundbeck were at least potential competitors at the time the agreements at issue were concluded |
| | A – Analiza v zvezi s potencialno konkurenco v izpodbijanem sklepu | | A – Analysis relating to potential competition in the contested decision |
| | B – Uporabljiva načela in sodna praksa | | B – Applicable principles and case-law |
| | 1. Pojem potencialna konkurenca | | 1. The concept of potential competition |
| | 2. Dokazno breme | | 2. The burden of proof |
| | 3. Obseg nadzora Splošnega sodišča | | 3. The extent of the Court’s review |
| | C – Prvi del: dajanje zdravil na trg, s katerimi so bile kršene pravice intelektualne lastnine tretjih oseb, ni izraz potencialne konkurence v smislu člena 101 PDEU | | C – The first part, alleging that the launch of medicinal products that infringe third parties’ intellectual property rights is not the expression of potential competition under Article 101 TFEU |
| | D – Drugi del: Komisija se je pri sklepu, da so bila generična podjetja dejanski ali potencialni konkurenti družbe Lundbeck, oprla na subjektivno presojo | | D – The second part, alleging that the Commission relied on subjective assessments in concluding that the generic undertakings were actual or potential competitors of Lundbeck |
| | E – Tretji del: izpodbijanje veljavnega patenta ne pomeni dejanskih in konkretnih možnosti za vstop na trg | | E – The third part, alleging that challenging a valid patent does not constitute a real concrete possibility of entering the market |
| | F – Četrti del: odsotnost DZP preprečuje obstoj dejanske ali potencialne konkurence | | F – The fourth part, alleging that the lack of an MA prevents the existence of actual or potential competition |
| | G – Peti del: generična podjetja naj med trajanjem spornih sporazumov ne bi mogla uporabljati drugih postopkov in/ali drugih proizvajalcev AFU | | G – The fifth part, alleging that the generic undertakings could not have had recourse to other processes and/or other API producers during the term of the agreements at issue |
| | H – Šesti del: odsotnost potencialne konkurence med družbo Lundbeck in podjetjem Merck (GUK) v času sklenitve spornih sporazumov | | H – The sixth part, alleging the absence of potential competition between Lundbeck and Merck (GUK) at the time the agreements at issue were concluded |
| | 1. Položaj v Združenem kraljestvu | | 1. The situation in the United Kingdom |
| | 2. Položaj v EGP | | 2. The situation in the EEA |
| | I – Sedmi del: neobstoj potencialne konkurence med družbo Lundbeck in podjetjem Arrow v času sklenitve spornih sporazumov | | I – The seventh part, alleging the absence of potential competition between Lundbeck and Arrow at the time the agreements at issue were concluded |
| | 1. Položaj v Združenem kraljestvu | | 1. The situation in the United Kingdom |
| | 2. Položaj na Danskem | | 2. The situation in Denmark |
| | J – Osmi del: neobstoj potencialne konkurence med družbo Lundbeck in podjetjem Alpharma v času sklenitve spornih sporazumov | | J – The eighth part, alleging the absence of potential competition between Lundbeck and Alpharma at the time the agreements at issue were concluded |
| | K – Deveti del: neobstoj potencialne konkurence med družbo Lundbeck in podjetjem Ranbaxy v času sklenitve spornih sporazumov | | K – The ninth part, alleging the absence of potential competition between Lundbeck and Ranbaxy at the time the agreements at issue were concluded |
| | II – Drugi, tretji, četrti, peti in šesti tožbeni razlog: v bistvu gre za kršitev člena 101(1) PDEU | | II – The second, third, fourth, fifth and sixth pleas in law, alleging, in essence, infringement of Article 101(1) TFEU |
| | A – Analiza obstoja omejitve konkurence „zaradi cilja“ v izpodbijanem sklepu | | A – Analysis relating to the existence of a restriction of competition ‘by object’ in the contested decision |
| | B – Uporabljiva načela in sodna praksa | | B – Applicable principles and case-law |
| | C – Drugi tožbeni razlog: očitno napačna uporaba prava in ugotovitev dejanskega stanja ter neobrazloženost pri presoji vloge prenosa vrednosti v spornih sporazumih | | C – The second plea in law, alleging a manifest error of law and of fact and a failure to state reasons in assessing the role of value transfers in the agreements at issue |
| | 1. Prvi del | | 1. The first part |
| | 2. Drugi del | | 2. The second part |
| | 3. Tretji del | | 3. The third part |
| | D – Tretji tožbeni razlog: očitno napačna uporaba prava pri uporabi načel v zvezi z omejevanjem konkurence zaradi cilja | | D – The third plea in law, alleging a manifest error of law in the application of the principles relating to the notion of restriction of competition by object |
| | 1. Prvi del | | 1. The first part |
| | 2. Drugi del | | 2. The second part |
| | 3. Tretji del | | 3. The third part |
| | 4. Četrti del | | 4. The fourth part |
| | E – Četrti tožbeni razlog: napačna uporaba prava in neobrazloženost pri zavrnitvi preizkusa obsega patenta kot bistvenega standarda presoje sporazumov o patentni poravnavi po členu 101(1) PDEU | | E – The fourth plea in law, alleging an error of law and a failure to state reasons in rejecting the scope-of-the-patent test as the key standard in assessing patent settlement agreements under Article 101(1) TFEU |
| | 1. Prvi del | | 1. The first part |
| | 2. Drugi del | | 2. The second part |
| | F – Peti tožbeni razlog: očitna napako pri presoji dejanskega stanja, kršitev dolžne skrbnosti in neobrazloženost, ker so bili ukrepi družbe Lundbeck opredeljeni kot celovita strategija proti vstopanju generikov, upoštevna za presojo spornih sporazumov po členu 101(1) PDEU | | F – The fifth plea in law, alleging a manifest error of assessment of the facts, breach of the duty of care and failure to state reasons in characterising Lundbeck’s actions as an overall strategy against the entry of generics to the market relevant for the assessment of the agreements at issue under Article 101(1) TFEU |
| | G – Šesti tožbeni razlog: očitno napačna presoja dejanskega stanja, ker je v izpodbijanem sklepu ugotovljeno, da sporni sporazumi vsebujejo omejitve, ki presegajo tiste, značilne za izvrševanje pravic na podlagi patentov družbe Lundbeck | | G – The sixth plea in law, alleging a manifest error of assessment of the facts in that the contested decision finds that the agreements at issue contained restrictions going beyond those inherent in the exercise of the rights conferred by Lundbeck’s patents |
| | 1. Sporazum GUK za Združeno kraljestvo | | 1. The GUK United Kingdom agreement |
| | 2. Sporazum GUK za EGP | | 2. The GUK EEA agreement |
| | 3. Sporazum Arrow UK | | 3. The Arrow UK agreement |
| | 4. Danski sporazum Arrow | | 4. The Arrow Danish agreement |
| | 5. Sporazum Alpharma | | 5. The Alpharma agreement |
| | 6. Sporazum Ranbaxy | | 6. The Ranbaxy agreement |
| | III – Sedmi tožbeni razlog: očitna napaka pri presoji, ker povečana učinkovitost na podlagi spornih sporazumov ni bilo pravilno ovrednotena | | III – The seventh plea in law, alleging a manifest error of assessment in that the efficiency gains of the agreements at issue were not properly evaluated |
| | IV – Osmi tožbeni razlog: kršitev pravice do obrambe | | IV – The eighth plea in law, alleging breach of the rights of the defence |
| | A – Prvi del | | A – The first part |
| | B – Drugi del | | B – The second part |
| | V – Deveti tožbeni razlog: podredno, očitno napačna uporaba prava pri naložitvi glob družbi Lundbeck | | V – The ninth plea in law, alleging, in the alternative that the imposition of fines on Lundbeck is vitiated by a manifest error of law |
| | A – Prvi del | | A – The first part |
| | B – Drugi del | | B – The second part |
| | VI – Deseti tožbeni razlog: še bolj podredno, očitno napačna uporaba prava in ugotovitev dejanskega stanja pri izračunu glob | | VI – The tenth plea in law, alleging, further in the alternative, manifest errors of law and of fact in calculating the fines |
| | A – Prvi del | | A – The first part |
| | B – Drugi del | | B – The second part |
| | C – Tretji del | | C – The third part |
| | D – Četrti del | | D – The fourth part |
| | Stroški | | Costs |
| ( *1 ) Jezik postopka: angleščina. | ( 1 ) Language of the case: English. |
