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Document 62014TJ0691

Judgment of the General Court (Ninth Chamber, Extended Composition) of 12 December 2018 (Extracts).
Servier SAS and Others v European Commission.
Competition — Agreements, decisions and concerted practices — Abuse of a dominant position — Market for perindopril, a medicinal product intended for the treatment of cardiovascular diseases, in its originator and generic versions — Decision finding an infringement of Articles 101 and 102 TFEU — Principle of impartiality — Consultation of the Advisory Committee on Restrictive Practices and Dominant Positions — Right to an effective remedy — Brevity of the period of time for lodging applications in the light of the length of the contested decision — Patent dispute settlement agreements — Licensing agreements — Technology acquisition agreements — Exclusive purchasing agreement — Potential competition — Restriction of competition by object — Restriction of competition by effect — Balance between competition law and patent law — Classification as separate infringements or as a single infringement — Definition of the relevant market at the level of the compound of the medicinal product concerned — Fines — Imposition of cumulative fines under Articles 101 and 102 TFEU — Principle that offences and penalties must have a proper legal basis — Value of sales — Method of calculation in the event of cumulative infringements on the same markets.
Case T-691/14.

ECLI identifier: ECLI:EU:T:2018:922

JUDGMENT OF THE GENERAL COURT (Ninth Chamber, Extended Composition)

12 December 2018 ( *1 )

(Competition — Agreements, decisions and concerted practices — Abuse of a dominant position — Market for perindopril, a medicinal product intended for the treatment of cardiovascular diseases, in its originator and generic versions — Decision finding an infringement of Articles 101 and 102 TFEU — Principle of impartiality — Consultation of the Advisory Committee on Restrictive Practices and Dominant Positions — Right to an effective remedy — Brevity of the period of time for lodging applications in the light of the length of the contested decision — Patent dispute settlement agreements — Licensing agreements — Technology acquisition agreements — Exclusive purchasing agreement — Potential competition — Restriction of competition by object — Restriction of competition by effect — Balance between competition law and patent law — Classification as separate infringements or as a single infringement — Definition of the relevant market at the level of the compound of the medicinal product concerned — Fines — Imposition of cumulative fines under Articles 101 and 102 TFEU — Principle that offences and penalties must have a proper legal basis — Value of sales — Method of calculation in the event of cumulative infringements on the same markets)

In Case T‑691/14,

Servier SAS, established in Suresnes (France),

Servier Laboratories Ltd, established in Wexham (United Kingdom),

Les Laboratoires Servier SAS, established in Suresnes,

represented initially by I.S. Forrester QC, J. Killick, Barrister, O. de Juvigny, lawyer, and M. Utges Manley, Solicitor, and subsequently by J. Killick, O. de Juvigny, M. Utges Manley, J. Jourdan and T. Reymond, lawyers,

applicants,

supported by

European Federation of Pharmaceutical Industries and Associations (EFPIA), established in Geneva (Switzerland), represented by F. Carlin, Barrister, N. Niejahr and C. Paillard, lawyers,

intervener,

v

European Commission, represented initially by T. Christoforou, B. Mongin, C. Vollrath, F. Castilla Contreras and T. Vecchi, and subsequently by T. Christoforou, B. Mongin, C. Vollrath, F. Castilla Contreras and J. Norris-Usher, acting as Agents,

defendant,

APPLICATION under Article 263 TFEU for annulment of Commission Decision C(2014) 4955 final of 9 July 2014 relating to a proceeding under Article 101 and Article 102 TFEU [Case AT.39612 — Perindopril (Servier)] in so far as it concerns the applicants and, in the alternative, for reduction of the fine imposed on the applicants by that decision,

THE GENERAL COURT (Ninth Chamber, Extended Composition),

composed of S. Gervasoni (Rapporteur), President, E. Bieliūnas, L. Madise, R. da Silva Passos and K. Kowalik-Bańczyk, Judges,

Registrar: G. Predonzani, Administrator,

having regard to the written part of the procedure and further to the hearing on 6 to 9 June 2017,

gives the following

Judgment ( 1 )

I. Background to the dispute

A. The applicants

1

The Servier group, composed, inter alia, of Servier SAS, its parent company established in France, Les Laboratoires Servier SAS and Servier Laboratories Ltd (individually or jointly, ‘Servier’ or ‘the applicants’), brings together pharmaceutical companies at the global level. Stichting FIRS, a non-profit foundation under Netherlands law, has exclusive control over the operation of the group’s parent company.

B. Perindopril and its patents

1.   Perindopril

2

Servier developed perindopril, a medicinal product used in cardiovascular medicine, primarily intended for the treatment of hypertension and heart failure, by inhibiting the angiotensin converting enzyme (‘ACE’).

3

The active pharmaceutical ingredient of perindopril (‘API’), that is to say, the biologically active chemical substance which produces the desired therapeutic effects, takes the form of a salt. The salt used initially was erbumine (or tert-butylamine), which is in its crystalline form on account of the synthesis process applied by Servier.

2.   Compound patent

4

The perindopril compound patent (patent EP0049658, ‘the 658 patent’) was filed with the European Patent Office (EPO) on 29 September 1981. The 658 patent was due to expire on 29 September 2001, but protection was prolonged in a number of EU Member States, including the United Kingdom, until 22 June 2003, in accordance with 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). In France, protection under the 658 patent was prolonged until 22 March 2005 and, in Italy, until 13 February 2009.

3.   Secondary patents

5

In 1988, Servier also filed a number of patents before the EPO relating to processes for the manufacture of the perindopril compound with an expiry date of 16 September 2008: patents EP0308339, EP0308340, EP0308341 and EP0309324 (respectively, ‘the 339 patent’, ‘the 340 patent’, ‘the 341 patent’ and ‘the 324 patent’).

6

Servier filed new patents relating to erbumine and its manufacturing processes with the EPO in 2001, including patent EP1294689 (known as ‘the beta patent’ — ‘the 689 patent’), patent EP1296948 (known as ‘the gamma patent’ — ‘the 948 patent’), and patent EP1296947 (known as ‘the alpha patent’ — ‘the 947 patent’).

7

The 947 patent application relating to the alpha crystalline form of erbumine and the process for its preparation was filed on 6 July 2001 and granted by the EPO on 4 February 2004.

8

Servier also filed national patent applications in several EU Member States before they were parties to the Convention on the Grant of European Patents, which was signed in Munich on 5 October 1973 and entered into force on 7 October 1977 (‘the EPC’). Servier filed, for example, patent applications relating to the 947 patent in Bulgaria (BG 107532), the Czech Republic (PV 2003-357), Estonia (P200300001), Hungary (HU225340), Poland (P348492) and Slovakia (PP0149-2003). All the patent applications in question were filed on the same date: 6 July 2001. The patents were granted on 16 May 2006 in Bulgaria, on 17 August 2006 in Hungary, on 23 January 2007 in the Czech Republic, on 23 April 2007 in Slovakia and on 24 March 2010 in Poland.

4.   Second generation perindopril

9

From 2002, Servier began developing a second generation perindopril product, manufactured using another salt, arginine, instead of erbumine. Perindopril arginine showed improvements in terms of shelf life, which increased from two to three years; stability, enabling the use of a single type of packaging for all climatic zones; and storage, since it required no particular storage conditions.

10

Servier applied for a European patent for perindopril arginine (patent EP1354873B, ‘the 873 patent’) on 17 February 2003. The 873 patent was granted to Servier on 17 July 2004 with an expiry date of 17 February 2023. The introduction of perindopril arginine in the European Union markets started in 2006.

C. Disputes relating to perindopril

1.   Disputes before the EPO

11

Ten generic companies, including Niche Generics Ltd (‘Niche’), Krka Tovarna Zdravil d.d. (‘Krka’), Lupin Ltd and Norton Healthcare Ltd, a subsidiary of Ivax Europe (‘Ivax’) which subsequently merged with Teva Pharmaceuticals Ltd (individually or together with other members of the Teva group, ‘Teva’), filed opposition proceedings against the 947 patent before the EPO in 2004, seeking the revocation in full of that patent on grounds of lack of novelty, lack of inventive step and insufficient disclosure of the invention.

12

On 27 July 2006, the Opposition Division of the EPO confirmed the validity of the 947 patent after Servier made some minor amendments to its original claims (‘the EPO decision of 27 July 2006’). Seven companies brought an appeal against that decision. Niche withdrew from the opposition procedure on 9 February 2005, Krka on 11 January 2007 and Lupin on 5 February 2007. By decision of 6 May 2009, the EPO’s Technical Board of Appeal annulled the EPO decision of 27 July 2006 and revoked the 947 patent. Servier’s request for a revision of that decision was rejected on 19 March 2010.

13

On 11 August 2004, Niche also filed an opposition against the 948 patent before the EPO, but withdrew from the procedure on 14 February 2005.

14

On 13 April 2005, Teva filed opposition proceedings against the 873 patent. The Opposition Division rejected that opposition on the ground that Teva had not demonstrated that that patent had insufficient inventive step. On 22 December 2008, Teva filed an appeal against that decision, before withdrawing the appeal on 8 May 2012.

2.   Disputes before the national Courts

15

The validity of the 947 patent has, moreover, been challenged by generic companies before the courts of certain Member States, notably in the Netherlands and the United Kingdom.

(a)   Dispute between Servier and Niche and Servier and Matrix

16

In the United Kingdom, on 25 June 2004, Servier brought an action for infringement before the High Court of Justice (England & Wales), Chancery Division (Patents Court), against Niche, in relation to the 339, 340 and 341 patents, after Niche applied for marketing authorisations in the United Kingdom for a generic version of perindopril, developed in partnership with Matrix Laboratories Ltd (‘Matrix’) under an agreement concluded on 26 March 2001 (‘the Niche-Matrix agreement’). On 9 July 2004 Niche served on Servier a counterclaim for a declaration of invalidity of the 947 patent.

17

The hearing before the High Court of Justice (England & Wales), Chancery Division (Patents Court), concerning the merits of the alleged infringement, was finally scheduled for 7 and 8 February 2005, but lasted for only half a day because a settlement agreement was concluded between Servier and Niche on 8 February 2005, which put an end to the litigation between those parties.

18

Matrix was kept informed by Niche on the progress of that litigation procedure and was also associated with that procedure as it gave evidence before the High Court of Justice (England & Wales), Chancery Division (Patents Court), on behalf of Niche. Moreover, on 7 February 2005, Servier sent a formal warning letter to Matrix, accusing it of infringing the 339, 340 and 341 patents and threatening to bring an action for infringement.

19

In the autumn of 2004, Servier began to consider acquiring Niche. To that end, Servier carried out a due diligence, of which the first phase was completed on 10 January 2005, the date on which Servier submitted a preliminary non-binding offer to acquire Niche’s capital for an amount between 15 and 45 million pounds sterling (GBP). Following the second phase of the due diligence, which took place on 21 January 2005, Servier informed Niche verbally on 31 January 2005 that it did not wish to proceed with the acquisition.

(b)   Disputes between Servier and Ivax and Servier and Teva

20

In the United Kingdom, on 9 August 2005, Ivax requested the revocation of the 947 patent before the High Court of Justice (England & Wales), Chancery Division (Patents Court). In October 2005, Servier and Ivax decided, however, to stay the proceedings until the adoption of the final decision in the opposition proceedings before the EPO. In return, Servier gave Ivax, its licensees and its customers an undertaking that, for the period of the stay and in the United Kingdom, it would not commence proceedings, seek an account of profits or any financial relief other than a reasonable royalty in respect of any acts of infringement of the 947 patent, or seek injunctive relief or delivery up. Servier also undertook to continue proceedings before the EPO diligently and not to seek an interim injunction in any infringement action brought once the proceedings before the EPO had been concluded.

21

In the Netherlands, on 15 August 2007, Pharmachemie BV, a Teva subsidiary, brought an action before the Rechtbank Den Haag (District Court, The Hague, Netherlands) for revocation of the 947 patent, as validated in the Netherlands, on grounds of lack of novelty and inventive step and for non-reproducibility. The Rechtbank Den Haag (District Court, The Hague) upheld that action on 11 June 2008. Servier appealed against that judgment on 7 October 2008 but did not subsequently submit a statement of objections.

(c)   Disputes between Servier and Krka

22

In Hungary, on 30 May 2006, Servier applied for an interim injunction preventing the marketing of a generic version of perindopril placed on the market by Krka, as a result of the infringement of the 947 patent. That application was rejected in September 2006.

23

In the United Kingdom, on 28 July 2006, Servier brought an action for infringement of the 340 patent against Krka before the High Court of Justice (England & Wales), Chancery Division (Patents Court). On 2 August 2006, it also brought an action for infringement of the 947 patent against Krka and applied for an interim injunction. On 1 September 2006, Krka brought a counterclaim for annulment of the 947 patent and, on 8 September 2006, a separate counterclaim for annulment of the 340 patent. On 3 October 2006, the High Court of Justice (England & Wales), Chancery Division (Patents Court), granted Servier’s application for an interim injunction and denied the motion for summary judgment brought by Krka on 1 September 2006 seeking the invalidation of the 947 patent. On 1 December 2006, the infringement proceedings were discontinued as a result of the settlement reached between the parties and the interim injunction was lifted.

(d)   Dispute between Servier and Lupin

24

On 18 October 2006, Lupin submitted an application to the High Court of Justice (England & Wales), Chancery Division (Patents Court), for a declaration of invalidity of the 947 patent, as validated in the United Kingdom, and a declaration that the generic version of perindopril which it intended to market in the United Kingdom did not infringe that patent.

(e)   Disputes between Servier and Apotex

25

In the United Kingdom, Servier brought an action for infringement before the High Court of Justice (England & Wales), Chancery Division (Patents Court), against the company Apotex Inc. on 1 August 2006, claiming infringement of the 947 patent, since Apotex had launched a generic version of perindopril in the United Kingdom on 28 July 2006. Apotex brought a counterclaim for annulment of that patent. An interim injunction prohibiting Apotex from importing, offering to sell or selling perindopril was obtained on 8 August 2006. On 6 July 2007, the High Court of Justice (England & Wales), Chancery Division (Patents Court), ruled that the 947 patent was invalid because it lacked novelty and inventive step over the 341 patent. Consequently, the injunction was lifted immediately and Apotex was able to resume selling its generic version of perindopril on the United Kingdom market. On 9 May 2008, the Court of Appeal (England & Wales) (Civil Division) dismissed Servier’s appeal against the judgment of the High Court of Justice (England & Wales), Chancery Division (Patents Court).

26

On 9 October 2008, the High Court of Justice (England & Wales), Chancery Division (Patents Court), awarded damages to Apotex in the amount of GBP 17.5 million on account of the loss of revenue suffered during the period when the injunction was in force. On 29 March 2011, however, the High Court of Justice (England & Wales), Chancery Division (Patents Court), ordered Apotex to repay that sum to Servier on the basis of the ex turpi causa principle, since a valid Canadian patent protected the perindopril compound until 2018 and Apotex produced and sold its product in Canada. However, the Court of Appeal (England and Wales) (Civil Division) set aside that decision by judgment of 3 May 2012. On 29 October 2014, the Supreme Court of the United Kingdom dismissed Servier’s appeal against the judgment of the Court of Appeal (England and Wales) (Civil Division).

27

In the Netherlands, on 13 November 2007, Katwijk Farma BV, an Apotex subsidiary, brought an action before the Rechtbank Den Haag (District Court, The Hague) for annulment of the 947 patent, as validated in the Netherlands. Servier applied for an interim injunction against Katwijk Farma on 7 December 2007, which was rejected by the Rechtbank Den Haag (District Court, The Hague) on 30 January 2008. Following the annulment of the 947 patent for the Netherlands on 11 June 2008 by the Rechtbank Den Haag (District Court, The Hague) in the context of the action brought by Pharmachemie BV, Servier and Katwijk Farma withdrew from the ongoing proceedings.

D. Patent dispute settlements

28

Servier entered into a series of patent settlement agreements with a number of generic companies with which it was involved in patent disputes. However, it did not enter into a settlement agreement with Apotex.

1.   Agreements concluded by Servier with Niche and Unichem and with Matrix

29

On 8 February 2005, Servier concluded two settlement agreements, one with Niche and its parent company, Unichem Laboratories Ltd (‘Unichem’), and the other with Matrix. On the same day, Niche concluded a licensing and supply agreement with Biogaran, a wholly-owned subsidiary of Les Laboratoires Servier.

30

The agreement concluded by Servier with Niche and Unichem (‘the Niche agreement’) covered all the countries in which the 339, 340, 341 and 947 patents existed (Clause 3).

31

Under the Niche agreement, Niche and Unichem were to refrain from making, having made, keeping, importing, supplying, offering to supply or disposing of generic perindopril made using the process developed by Niche, which Servier regarded as infringing the 339, 340 and 341 patents, as validated in the United Kingdom, using a substantially similar process or using any other process that would infringe the 339, 340 and 341 patents (‘the process at issue’) until the local expiry date of those patents (Clause 3). However, they would be free, under the Niche agreement, to market perindopril made using the process at issue without infringing the patents after the expiry of those patents (Clauses 4 and 6). Moreover, Niche was required to cancel, terminate or suspend until the expiry date of the patents all of its existing contracts relating, on the one hand, to perindopril made using the process at issue and, on the other, to marketing authorisation applications for that perindopril (Clause 11). Furthermore, Niche and Unichem undertook not to make any applications for marketing authorisations for perindopril made using the process at issue and not to assist any third parties to obtain such a marketing authorisation (Clause 10). Lastly, they were to abstain from any invalidity and non-infringement actions against the 339, 340, 341, 947, 689 and 948 patents until their expiry, except as a defence to a patent infringement action (Clause 8). Niche also agreed to withdraw its oppositions to the 947 and 948 patents before the EPO (Clause 7).

32

In return, Servier undertook, first, not to bring any infringement actions against Niche, Niche customers or Unichem based on the 339, 340, 341 and 947 patents in respect of any act of alleged infringement occurring before the conclusion of the Niche agreement (Clause 5) and, secondly, to pay Niche and Unichem the sum of GBP 11.8 million in two instalments (Clause 13). That sum was to be paid in consideration for the commitments made by Niche and Unichem and for the ‘substantial costs and potential liabilities that may be incurred by Niche and Unichem as a consequence of ceasing their programme to develop perindopril made using the process [at issue]’.

33

Moreover, on 8 February 2005, Niche concluded a licensing and supply agreement with Biogaran (‘the Biogaran agreement’), relating to the transfer, first, of all the information and data which Niche held concerning three medicinal products and which were necessary to obtain marketing authorisations and, secondly, of its French marketing authorisation for one of those medicinal products. In return, Biogaran was to pay Niche the sum of GBP 2.5 million, which was non-refundable even if Biogaran failed to obtain the marketing authorisations. Biogaran was also required, after obtaining its marketing authorisations, to order the products concerned from Niche. In the event that the marketing authorisations were not obtained within 18 months of the date of entry into force of the agreement, that agreement would be automatically terminated (Clause 14.4), without either party being entitled to any compensation (Clause 14.5).

34

The agreement concluded by Servier with Matrix (‘the Matrix agreement’) covered all the countries in which the 339, 340, 341 and 947 patents existed, with the exception of one non-Member State of the European Economic Area (EEA) (Section 1(1)(xiii) of the Matrix agreement).

35

Under the Matrix agreement, Matrix committed to refrain from making, having made, keeping, importing, supplying, offering to supply or disposing of perindopril made using the process at issue until the local expiry date of those patents (Clauses 1 and 2). However, the agreement stipulated that Matrix would be free to deal in perindopril made using the process at issue without infringing the patents after the expiry of those patents (Clause 4). Moreover, Matrix was required to cancel, terminate or suspend until the expiry date of the patents all of its existing contracts relating to perindopril made using the process at issue and to marketing authorisation applications for that perindopril by 30 June 2005 at the latest (Clauses 7 and 8). Furthermore, it committed not to apply for marketing authorisations for perindopril made using the process at issue and not to assist any third parties to obtain such a marketing authorisation (Clause 6). Finally, Matrix was to abstain from any invalidity and non-infringement actions against the 339, 340, 341, 947, 689 and 948 patents until their expiry, except as a defence to a patent infringement action (Clause 5).

36

In return, Servier committed, first, not to bring any infringement actions against Matrix, based on the 339, 340, 341 and 947 patents, in respect of any act of alleged infringement occurring before the conclusion of the Matrix agreement (Clause 3) and, secondly, to pay Matrix the sum of GBP 11.8 million in two instalments (Clause 9). That sum was consideration for the commitments made by Matrix and for the ‘substantial costs and potential liabilities that may be incurred by Matrix as a consequence of ceasing its programme to develop and manufacture perindopril made using the process [at issue]’.

2.   Agreement concluded by Servier with Teva

37

On 13 June 2006, Servier concluded a settlement and exclusive purchasing agreement with Teva (‘the Teva agreement’). The perindopril referred to in the Teva agreement was perindopril erbumine (Clause 1.12).

38

Under the clauses concerning the settlement agreement, Teva undertook to destroy all perindopril owned or controlled by it and intended for sale in the United Kingdom (Clause 2.2). Moreover, Teva was to refrain, in the United Kingdom, from making, having made, keeping, importing, supplying, offering to supply or disposing of generic perindopril either manufactured in accordance with the process it had developed, which was considered by Servier to infringe the 947 and 339 to 341 patents, as validated in the United Kingdom, or infringing those patents until the termination or expiration of the Teva agreement or the expiration of those patents (Clause 2.3). Furthermore, Teva undertook not to challenge the abovementioned patents in the United Kingdom for the duration of the Teva agreement, it being stipulated that Teva was not prevented from continuing opposition proceedings against the disputed patents before the EPO (Clause 2.4).

39

In return for Teva’s undertakings, Servier undertook to waive any claims against Teva in respect of any infringement of the disputed patents in the United Kingdom prior to the entry into force of the Teva agreement (Clause 2.1).

40

Under the clauses concerning the exclusive purchasing obligation, Teva undertook to purchase exclusively from Servier all of its requirements for generic perindopril intended for distribution in the United Kingdom for the duration of the Teva agreement (Clauses 3.1 and 1.14). In the case of failure to supply by Servier, Teva had no other right of remedy or termination, but the right to payment of liquidated damages of GBP 500000 per month (Clauses 1.8 and 3.8.3).

41

Under the general provisions of the Teva agreement, that agreement had a duration of three years and was renewable for an additional two year period (Clauses 8.1 and 8.2). Moreover, on signature of the Teva agreement, upon presentation of an ‘appropriate invoice’, Servier had to pay Teva GBP 5 million as a ‘contribution towards the costs incurred by Teva in preparing to enter into this Agreement, including, without limitation, the costs of terminating its existing supply arrangements for the United Kingdom’ (Clause 10).

42

On 23 February 2007, Servier and Teva concluded an amendment to the Teva agreement (‘the amendment to the Teva agreement’), confirming the actual implementation of the exclusive purchasing obligation by setting a date on which Teva could start to distribute the generic perindopril supplied by Servier. That date either had to be set unilaterally by Servier, or it had to correspond to the date of revocation or expiry of the 947 patent, or be the date on which Apotex commenced distribution of generic perindopril in the United Kingdom following the settlement of its dispute with Servier.

3.   Agreements concluded by Servier with Krka

43

On 27 October 2006, Servier entered into a settlement agreement and a licence agreement with Krka, supplemented by an amendment made on 2 November 2006.

44

The settlement agreement with Krka provides that the 947 patent also covers equivalent national patents (Annex B).

45

In accordance with the settlement agreement with Krka, in force until the expiry or the revocation of the 947 or 340 patents, Krka undertook to withdraw any existing claim against the 947 patent worldwide and against the 340 patent in the United Kingdom, and not to challenge either of those patents worldwide in the future (Clause I(ii)). Moreover, Krka and its subsidiaries were not authorised to launch or to market any generic form of perindopril which would infringe the 947 patent for the duration of the validity of that patent and in the country in which it was still valid, unless otherwise expressly authorised by Servier (Clause V). Similarly, Krka could not supply to any third party a generic version of perindopril that would infringe the 947 patent, unless otherwise expressly authorised by Servier (Clause V(2)). In return, Servier was required to withdraw the proceedings pending worldwide against Krka based on the infringement of the 947 and the 340 patents, including its applications for interim injunction (Clause I(i)).

46

Pursuant to the licence agreement concluded with Krka for a period corresponding to the validity of the 947 patent (Article 5), Servier granted Krka an exclusive, irrevocable licence on the 947 patent to use, manufacture, sell, offer for sale, promote and import its own products which contain the alpha crystalline form of erbumine (Article 2) in the Czech Republic, Latvia, Lithuania, Hungary, Poland, Slovenia and Slovakia (Article 1). In return, Krka was required to pay Servier 3% royalties on its net sales prices throughout those territories (Article 3). Servier was entitled, in those States, to use the 947 patent directly or indirectly (that is to say for one of its subsidiaries or for one third party per country) (Article 2).

47

On 5 January 2007, Servier also entered into an assignment and licence agreement with Krka.

48

Pursuant to the assignment and licence agreement, Krka assigned two patent applications to Servier, one concerning a process for the preparation of perindopril (WO 2005 113500) and the other the preparation of formulations of perindopril (WO 2005 094793) (Article 1). The technology protected in those patent applications was used for the production of Krka’s perindopril.

49

Krka undertook not to challenge the validity of any patents granted on the basis of the applications at issue (Article 3).

50

In return for that assignment, Servier paid Krka EUR 15 million for each of the applications at issue (Article 2).

51

Servier also granted Krka a non-exclusive, irrevocable, non-assignable, royalty-free licence, with no right to sub-license (other than to its subsidiaries) on the applications or resulting patents, that licence being unrestricted in time, territory or scope of use (Article 4).

4.   Agreement concluded by Servier with Lupin

52

On 30 January 2007, Servier entered into a settlement agreement with Lupin (‘the Lupin agreement’).

53

Both parties thus decided to bring an end to the disputes between them concerning perindopril (Clauses 1.1, 1.2 and 1.4).

54

Moreover, Lupin undertook not to directly or indirectly seek or assist or procure any third party to revoke, invalidate or challenge the 947 patent or any patent held by Servier or its subsidiaries protecting perindopril, in any country other than a specific non-Member State of the EEA (Clause 1.3). Furthermore, Lupin and its subsidiaries were to refrain from selling or offering for sale any pharmaceutical product containing, as an API, ‘perindopril[-]erbumine … and any salt thereof’ in any country other than a specific non-EEA Member State (Clause 1.6). Lupin was, however, authorised to market products supplied by Servier or its own perindopril in countries where a generic version of perindopril authorised by Servier was on the market or in the event that all Servier’s relevant patents had expired or in countries in which a third party had placed a generic version of perindopril on the market and in which Servier had not brought any application for injunction seeking the prohibition of its sale (Clauses 1.6 and 4.1).

55

Moreover, in the context of the Lupin agreement, Servier and Lupin also concluded an agreement for the assignment of intellectual property rights and a licence agreement.

56

Servier acquired three perindopril process patent applications filed by Lupin:

application W0 2004/075889 (EP 1603558 B1) relating to a new process for the preparation of perindopril and salts thereof for EUR 20 million;

application W0 2006/097941 (EP 1861367 A) relating to a new and improved process for the purification of perindopril for EUR 10 million;

application W0 2005/037788 (EP 1675827 A1) relating to a new process for the preparation of ‘crystalline perindopril erbumine’ for EUR 10 million.

57

Servier also granted Lupin a non-exclusive, non-transferable, non-sublicensable, royalty-free, perpetual and irrevocable licence on those three patent applications for the purposes of manufacturing perindopril in the countries covered by the applications at issue (Clause 3.1).

58

The Lupin agreement provided, lastly, for the conclusion, within four weeks, of a supply contract between the parties, which was not, however, concluded.

E. The acquisition of enabling technologies

59

On 3 September 2001, the applicants concluded an agreement with Rolabo SL concerning the sale of a patent application filed by Rolabo on 24 July 2001, relating to a perindopril API and to a chemical dossier for the perindopril API, for 10 million US dollars (USD).

60

On 9 November 2004, the applicants concluded with Azad Pharmaceutical Ingredients AG (‘Azad’) an agreement to assign a patent application filed by Azad for two new polymorphic forms of perindopril, the delta and epsilon forms, and the related know-how worldwide, for an amount of EUR 13374243.

61

On 15 October 2007, the applicants concluded a memorandum of understanding with Sandoz AG, which provided that they would proceed with the acquisition of the perindopril API technology developed by Sandoz — if that technology proved to be a patent-free and industrially viable source of competition — for an amount possibly exceeding USD 50 million. Negotiations continued until July 2008, but no agreement was ultimately concluded.

F. The Sector Inquiry

62

On 15 January 2008, the Commission of the European Communities decided to open an inquiry into the pharmaceutical sector pursuant to Article 17 of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles [101] and [102 TFEU] (OJ 2003 L 1, p. 1) in order to identify the factors contributing to the decline in innovation in that sector, measured by the number of new medicines reaching the market, and the reasons for the delayed entry into the market of certain generic medicines.

63

The Commission published a preliminary report on the results of its inquiry on 28 November 2008, followed by a public consultation. On 8 July 2009, it adopted a communication giving a summary of its pharmaceutical sector inquiry report. The Commission stated, inter alia, in that communication, that the monitoring of patent settlements concluded between originator companies and generic companies should continue in order better to understand the use of that type of agreement and to identify those agreements that delay generic market entry to the detriment of EU consumers and may constitute an infringement of competition rules. The Commission subsequently published six annual reports on the monitoring of patent settlement agreements.

G. The administrative procedure and the contested decision

64

On 24 November 2008, the Commission made unannounced inspections, inter alia, of Servier’s premises. The Commission sent requests for information to several companies, including Servier, in January 2009. On 2 July 2009 the Commission decided to open proceedings.

65

In August 2009 and then between December 2009 and May 2012, the Commission sent new requests for information to Servier. As the latter refused to respond to certain parts of the requests for information of 7 February and 11 April 2011 relating to the Biogaran agreement, the Commission adopted a decision based on the provisions of Article 18(3) of Regulation No 1/2003. Servier provided the requested information on 7 November 2011.

66

Between 2009 and 2012, Servier was invited to attend a number of state of play meetings.

67

On 27 July 2012, the Commission issued a Statement of Objections to several companies including Servier, which submitted its reply on 14 January 2013.

68

Following the hearing of the companies concerned on 15, 16, 17 and 18 April 2013, further state of play meetings were arranged and additional requests for information sent to Servier.

69

On 18 December 2013, the Commission granted Servier access to evidence gathered or more widely disclosed after the Statement of Objections and sent a Letter of Facts to which Servier replied on 31 January 2014. The hearing officer issued his final report on 7 July 2014.

70

On 9 July 2014, the Commission adopted Decision C(2014) 4955 final relating to a proceeding under Article 101 and Article 102 TFEU [Case AT.39612 — Perindopril (Servier)] (‘the contested decision’), which was notified to the applicants on 11 July 2014.

71

The Commission considered that the applicants had infringed, first, Article 101 TFEU by participating in five patent settlement agreements with reverse payments (Articles 1 to 5 of the contested decision) and, secondly, Article 102 TFEU by drawing up and implementing — by means of technology acquisition and those five settlement agreements — an exclusionary strategy covering the market for formulations of perindopril in France, the Netherlands, Poland and the United Kingdom and the market for perindopril API technology (Article 6 of the contested decision).

72

For the infringements of Article 101 TFEU, the Commission imposed the following fines on the applicants, totalling EUR 289727200 (Article 7(1) to (5) of the contested decision):

in respect of the Niche agreement: EUR 131532600, jointly and severally with Biogaran;

in respect of the Matrix agreement: EUR 79121700;

in respect of the Teva agreement: EUR 4309000;

in respect of the agreements concluded with Krka: EUR 37661800;

in respect of the Lupin agreement: EUR 37102100.

73

For the infringement of Article 102 TFEU, the Commission imposed on the applicants a fine of EUR 41270000 (Article 7(6) of the contested decision).

II. Procedure and forms of order sought by the parties

74

By application lodged at the Registry of the General Court on 21 September 2014, the applicants brought the present action.

75

The applicants claim that the Court should:

annul, in whole or in part, Articles 1 to 8 of the contested decision in so far as they concern them;

in the alternative, annul or reduce by a very substantial amount the fines imposed on them;

grant them the benefit of any annulment, in whole or in part, of the contested decision in the actions brought by Biogaran and the other addressees of that decision;

order the Commission to pay the costs.

76

The Commission contends that the Court should:

dismiss the action;

order the applicants to pay the costs.

77

By document lodged on 2 February 2015, the European Federation of Pharmaceutical Industries and Associations (EFPIA) (‘the EFPIA’ or ‘the intervener’) sought leave to intervene in the proceedings in support of the form of order sought by the applicants.

78

The Commission requested confidential treatment, vis-à-vis the EFPIA, of certain elements of the application, the defence, the reply, the rejoinder, the response to certain measures of organisation of procedure, the observations relating to those responses and the applicants’ observations on the statement in intervention.

79

By order of the President of the Second Chamber of the Court of 14 October 2015, the EFPIA was granted leave to intervene in the present proceedings in support of the form of order sought by the applicants. Since the EFPIA did not challenge the requests for confidential treatment, the Court did not rule on whether they were well founded.

80

The intervener claims that the Court should:

annul the contested decision in so far as it concerns the applicants;

order the Commission to bear the costs of the intervener.

81

In the context of the measures of organisation of procedure provided for in Article 89(3)(a) and (d) of the Rules of Procedure of the General Court, the Commission was invited to respond in writing to questions and to produce documents relating, inter alia, to the consultation of the Advisory Committee on Restrictive Practices and Dominant Positions, to the calculation of the amount of the fine and to data concerning the agreements with Krka which were made confidential in the contested decision. It sent its replies within the prescribed period.

82

Following a change in the composition of the Chambers of the Court, the Judge-Rapporteur was assigned to the Ninth Chamber, to which the present case was accordingly allocated.

83

Acting on a proposal from the Ninth Chamber, the Court decided, pursuant to Article 28 of the Rules of Procedure, to assign the case to a Chamber sitting in extended composition.

84

Acting on a proposal from the Judge-Rapporteur, the Court decided to open the oral part of the procedure and, by way of measures of organisation of procedure pursuant to Article 89(3)(a) of the Rules of Procedure, put written questions to the parties, requesting them to answer those questions at the hearing.

85

On 24 February 2017, the parties were invited by the Court to attend an informal meeting, under Article 89(3)(e) of the Rules of Procedure, before the President of the Ninth Chamber (Extended Composition) of the General Court and Judge-Rapporteur, with a view to discussing the arrangements for the hearing and the confidential treatment of certain information. The applicants and the Commission attended that meeting, which was held at the Court on 3 May 2017.

86

At the hearing held from 6 to 9 June 2017, the parties presented oral argument and their answers to the written and oral questions put by the Court.

III. Law

A. Admissibility

1.   Admissibility of the third head of claim

(a)   Arguments of the parties

(b)   Findings of the Court

89

According to settled case-law, the conditions for the admissibility of an action concern an absolute bar to proceeding with the action which the Courts of the European Union may and must consider of their own motion should such an issue arise (judgments of 21 March 2002, Joynson v Commission, T‑231/99, EU:T:2002:84, paragraph 154, and of 14 December 2005, Honeywell v Commission, T‑209/01, EU:T:2005:455, paragraph 53). Therefore, even if the Commission, in its pleadings, did not dispute the admissibility of the applicants’ third head of claim, but did so only at the hearing in response to a question from the Court, it is for the Court to consider of its own motion the admissibility of that head of claim.

90

Under the first paragraph of Article 21 of the Statute of the Court of Justice of the European Union, applicable to the procedure before the General Court by virtue of the first paragraph of Article 53 thereof, and Article 44(1)(c) and (d) of the Rules of Procedure of the General Court of 2 May 1991, applicable at the time the action was brought, each application is required to state the subject matter of the proceedings, the form of order sought and a summary of the pleas in law on which the application is based. The purpose of that requirement is to obtain sufficiently clear and precise information to enable the defendant to defend itself properly and the EU judicature to exercise its power of review, if necessary without any further supporting information (judgments of 29 June 1995, ICI v Commission, T‑37/91, EU:T:1995:119, paragraph 42; of 24 February 2000, ADT Projekt v Commission, T‑145/98, EU:T:2000:54, paragraph 66; and of 16 March 2004, Danske Busvognmænd v Commission, T‑157/01, EU:T:2004:76, paragraph 45). Thus, as the Commission argued at the hearing, a general reference in the application to the pleas and arguments relied on in support of an action brought in a related case does not meet that requirement (judgment of 24 March 2011, Legris Industries v Commission, T‑376/06, not published, EU:T:2011:107, paragraph 32).

91

However, it should be noted that the Courts of the European Union were able to accept that pleas not expressly set out in the application could be regarded as validly raised by virtue of a reference to the pleas raised in another case in the event that the applicant had referred to its own written pleadings in another case (see judgment of 14 December 2005, Honeywell v Commission, T‑209/01, EU:T:2005:455, paragraphs 61 and 62 and the case-law cited). Those cases covered situations in which the parties were identical, as were the agents and lawyers representing them. On the other hand, the General Court held that to accept the admissibility of pleas in law not set out expressly in the application on the ground that they were raised by a third party in another case, to which reference is made in that application, would be to allow the mandatory requirements of Article 21 of the Statute of the Court of Justice of the European Union and of Article 44(1) of the Rules of Procedure of the General Court of 2 May 1991, to be circumvented (see, to that effect, judgments of 14 December 2005, Honeywell v Commission, T‑209/01, EU:T:2005:455, paragraphs 63 and 64; of 27 September 2012, Dura Vermeer Infra v Commission, T‑352/06, not published, EU:T:2012:483, paragraphs 25 and 26; of 27 September 2012, Koninklijke BAM Groep v Commission, T‑355/06, not published, EU:T:2012:486, paragraphs 26 and 27; and of 27 September 2012, Heijmans v Commission, T‑360/06, not published, EU:T:2012:490, paragraphs 25 and 26). Lastly, it must be recalled that each party is solely responsible for the content of the pleadings which it lodges, a rule laid down notably in Article 43(1) of the Rules of Procedure of 2 May 1991 (see, to that effect, judgments of 29 June 1995, ICI v Commission, T‑37/91, EU:T:1995:119, paragraph 46, and of 14 December 2005, Honeywell v Commission, T‑209/01, EU:T:2005:455, paragraph 66). In the present case, however, it is common ground that the applicants wish to rely on any possible annulment obtained by third parties and that, accordingly, neither the parties nor their representatives are identical.

92

Moreover, it should be recalled that a decision adopted in the sphere of competition law with respect to several undertakings, although drafted and published in the form of a single decision, must be seen as a set of individual decisions finding that each of the addressees is guilty of the infringement or infringements of which they are accused and imposing on them, where appropriate, a fine (see, to that effect, judgments of 14 September 1999, Commission and AssiDomän Kraft Products and Others, C‑310/97 P, EU:C:1999:407, paragraph 49, and of 15 October 2002, Limburgse Vinyl Maatschappij and Others v Commission, C‑238/99 P, C‑244/99 P, C‑245/99 P, C‑247/99 P, C‑250/99 P to C‑252/99 P and C‑254/99 P, EU:C:2002:582, paragraph 100). The Court of Justice has held that, if an addressee of a decision decided to bring an action for annulment, the matter to be tried by the EU judicature related only to those aspects of the decision which concern that addressee, whereas aspects concerning other addressees did not form part of the matter to be tried by the EU judicature (judgments of 14 September 1999, Commission and AssiDomän Kraft Products and Others, C‑310/97 P, EU:C:1999:407, paragraph 53; of 29 March 2011, ArcelorMittal Luxembourg v Commission and Commission v ArcelorMittal Luxembourg and Others, C‑201/09 P and C‑216/09 P, EU:C:2011:190, paragraph 142; and of 11 July 2013, Team Relocations and Others v Commission, C‑444/11 P, not published, EU:C:2013:464, paragraph 66). Consequently, the Court of Justice considers that, in principle, the authority of a ground of a judgment annulling a measure cannot apply to the situation of persons who were not parties to the proceedings and with regard to whom the judgment cannot therefore have decided anything whatever (judgment of 14 September 1999, Commission and AssiDomän Kraft Products and Others, C‑310/97 P, EU:C:1999:407, paragraph 55). Accordingly, the annulment of an individual decision has an erga omnes effect and is binding on everyone, but such annulment does not benefit everyone, unlike the annulment of an act of general application (see judgment of 15 July 2015, Emesa-Trefilería and Industrias Galycas v Commission, T‑406/10, EU:T:2015:499, paragraph 126 and the case-law cited).

93

Nevertheless, the Court of Justice introduced a qualification of that principle in the judgment of 22 January 2013, Commission v Tomkins (C‑286/11 P, EU:C:2013:29, paragraphs 43 to 49), in which it held that, to the extent that the liability of the parent company was derived exclusively from that of its subsidiary and where the parent company and its subsidiary had brought parallel actions having the same object, the General Court had not ruled ultra petita by taking into account the outcome of the action brought by the subsidiary in order to annul the contested decision in respect of the period in question as regards the parent company, even though the parent company had not challenged the existence of the infringement for the whole of the period challenged by its subsidiary. Nevertheless, the Court of Justice, in order to be able to apply such a solution to the fine imposed on a parent company whose liability is derived solely from that of its subsidiary, considered that there had to be special circumstances, inter alia the two companies had to have raised pleas ‘having the same object’ and the applicant parent company had to claim that such circumstances existed (see, to that effect, judgment of 11 July 2013, Team Relocation v Commission, C‑444/11 P, not published, EU:C:2013:464, paragraph 66).

94

However, the Court of Justice did not define that concept of ‘same object’ and has developed its position on the question whether special circumstances such as those at issue in the judgment of 22 January 2013, Commission v Tomkins (C‑286/11 P, EU:C:2013:29), involved a matter of public policy and had to be raised by a court of its own motion. Accordingly, it first applied that solution when two companies had contested the duration of the infringement and at least part of the contested period was identical (judgment of 22 January 2013, Commission v Tomkins, C‑286/11 P, EU:C:2013:29, paragraphs 43 and 44). The Court of Justice nevertheless also upheld a judgment of the General Court which adopted the same approach where the subsidiary had obtained a reduction in the amount of the fine imposed on it, on the basis of a failure properly to take into account its cooperation under the leniency programme, holding, in that case, that the parent company had sought, in the alternative, the reduction of the fine imposed on its subsidiary and, jointly and severally, on itself, and that ‘the purpose of [certain of its] pleas in law was, inter alia, to justify the grant of such a reduction’ (judgment of 26 September 2013, Alliance One International v Commission, C‑679/11 P, not published, EU:C:2013:606, paragraphs 103 to 107). Finally, in a judgment of 17 September 2015, Total v Commission (C‑597/13 P, EU:C:2015:613, paragraphs 31 to 42), the Court of Justice criticised a judgment of the General Court which failed to take into account, in the judgment relating to the parent company, a reduction in the amount of the fine granted to its subsidiary in another judgment delivered on the same day, on account of the method which the Commission, when calculating the amount of the fine, had used to define the multiplier corresponding to the duration of the infringement. However, the parent company had neither raised such a plea (it had, by contrast, contested the duration of the infringement) nor asked the General Court to be allowed to benefit from a reduction in the amount of the fine which had been imposed on it, if its subsidiary obtained such a reduction.

95

In the present case, Biogaran, a subsidiary of Servier, has also brought an action (case giving rise to the judgment delivered today, Biogaran v Commission (T‑677/14)) against Articles 1, 7 and 8 of the contested decision. Nevertheless, as the Commission pointed out at the hearing, the circumstances of the present case differ from those obtaining in the case which gave rise to the judgment of 22 January 2013, Commission v Tomkins (C‑286/11 P, EU:C:2013:29), and in the subsequent case-law, in particular in that the applicants’ liability is not solely derived from that of their subsidiary Biogaran (recitals 3006 to 3013 of the contested decision). Moreover, in any event, since the action brought by Biogaran in the case which gave rise to the judgment delivered today, Biogaran v Commission (T‑677/14), was dismissed by that judgment, the applicants’ claim to be allowed to benefit from any annulment in favour of Biogaran cannot succeed.

96

The applicants also claim that they should be allowed to benefit from any annulment obtained by another addressee of the contested decision ‘in order to avoid any difference in the treatment of situations which are legally and factually identical’. They argue that both the principle of equal treatment and a ‘general duty of consistency’ require application of that approach.

97

It must be recalled, in that regard, that the principle of equal treatment is a general principle of EU law, enshrined in Articles 20 and 21 of the Charter of Fundamental Rights of the European Union, which requires that comparable situations must not be treated differently and that different situations must not be treated in the same way unless such treatment is objectively justified (see judgment of 14 September 2010, Akzo Nobel Chemicals and Akcros Chemicals v Commission and Others, C‑550/07 P, EU:C:2010:512, paragraphs 54 and 55 and the case-law cited). A decision adopted in the sphere of competition law with respect to several undertakings, although drafted and published in the form of a single decision, must be seen as a set of individual decisions finding that each of the addressees is guilty of the infringement or infringements of which they are accused and imposing on them, where appropriate, a fine (see paragraph 92 above). Those undertakings are therefore, a priori, and without exception, in different situations. Consequently, the principle of equality of treatment does not allow the European Union judicature to derogate from the procedural rules governing the admissibility of the form of order sought by allowing an addressee of a competition law decision to benefit from annulment by another addressee of that decision on the basis of pleas raised only by the latter.

98

Moreover, the obligation on the General Court to state the reasons for its judgments cannot extend to imposing on it an obligation to justify the solution arrived at in one case in the light of that found in another, even if it concerned the same decision (see, to that effect, judgment of 11 July 2013, Team Relocation v Commission, C‑444/11 P, not published, EU:C:2013:464, paragraph 66).

99

It follows from the foregoing that the applicants’ third head of claim, seeking to benefit from any annulment obtained by other addressees of the contested decision on the basis of the pleas put forward by those other addressees, is inadmissible. Even if that head of claim were admissible, it must be rejected as unfounded, since the applicants cannot validly rely, for their benefit, as is apparent from paragraphs 92 to 98 above, on a solution adopted to the benefit of the other addressees of the contested decision.

2.   Admissibility of certain annexes to the application

(a)   Arguments of the parties

(b)   Findings of the Court

102

The Commission argues that Annexes A 2 and A 3 to the application are inadmissible under the maxim iura novit curia. The annexes, which have a purely evidential and instrumental function, cannot, in fact, be used for the discussion or further development of a point of EU law, which falls within the sole competence of the Court. The Commission relies on the judgments of 5 July 2011, Edwin v OHIM (C‑263/09 P, EU:C:2011:452, paragraph 53), and of 20 March 2013, El Corte Inglés v OHIM — Chez Gerard (CLUB GOURMET) (T‑571/11, EU:T:2013:145, paragraph 35), according to which the maxim iura novit curia applies only to EU law and not to national law. It should be recalled that that maxim means that it is solely for the court, and not the parties, to determine the meaning of the law. The case-law has applied that maxim in order to emphasise that, although the Court must rule only on the heads of claim put forward by the parties, whose role it is to define the framework of the dispute, the Court cannot confine itself to the arguments put forward by the parties in support of their claims, or it might be forced to base its decision on erroneous legal considerations (orders of 27 September 2004, UER v M6 and Others, C‑470/02 P, not published, EU:C:2004:565, paragraph 69, and of 13 June 2006, Mancini v Commission, C‑172/05 P, EU:C:2006:393, paragraph 41; judgments of 21 September 2010, Sweden and Others v API and Commission, C‑514/07 P, C‑528/07 P and C‑532/07 P, EU:C:2010:541, paragraph 65, and of 8 July 2010, Commission v Putterie-De-Beukelaer, T‑160/08 P, EU:T:2010:294, paragraph 65). Similarly, according to that maxim, determining the meaning of the law does not fall within the scope of application of a principle which allows the parties a free hand to determine the scope of the case and the EU Court is therefore not obliged to inform the parties of the interpretation it intends to give in order to enable them to adopt a position on that subject (see judgment of 5 October 2009, Commission v Roodhuijzen, T‑58/08 P, EU:T:2009:385, paragraph 36 and the case-law cited), without prejudice to compliance by the EU Court with the obligation to allow the parties to be apprised of, and to be able to debate and be heard on, the matters of fact and of law which will determine the outcome of the proceedings (judgment of 2 December 2009, Commission v Ireland and Others, C‑89/08 P, EU:C:2009:742, paragraph 56). That maxim cannot, however, mean that annexes to the application relating to the interpretation of EU law are inadmissible.

103

Moreover, the objection of inadmissibility raised by the Commission seems to be motivated by the fact that the two annexes at issue contain opinions given for the benefit of the applicants by Sir Jacobs and Ms Macken, in their capacity as lawyers, but whose status as former Members of the Court of Justice of the European Union is well known, and that the applicants are relying on that latter status. When the Commission was asked at the hearing whether, through its challenge to the admissibility of the legal opinions thus given, it intended to rely on the failure of those former members of the Court of Justice to fulfil their obligations under the Code of Conduct of the Members of the Court of Justice of the European Union (OJ 2007 C 223, p. 1), in particular under Article 6 of that Code of Conduct, concerning the undertakings of Members after ceasing to hold office, the Commission replied that it did not intend to do so. The Court took formal notice of this in the minutes of the hearing.

104

In the alternative, the Commission argues that, according to the case-law, a legal opinion annexed to an application is admissible only to support and supplement the essential elements which must be included in the application, provided that the relevant parts of the documents annexed are identified and referenced in the application. In the present case, with respect to certain pleas, the texts and arguments in Annexes A 2 and A 3 to the application contain most, if not all, of the applicants’ arguments.

105

It must be borne in mind, in that regard, that, according to the case-law set out in paragraph 90 above, under Article 21 of the Statute of the Court of Justice of the European Union and Article 44(1)(c) of the Rules of Procedure of the General Court of 2 May 1991, applicable at the time the action was brought, each application is required to state the subject matter of the proceedings and a summary of the pleas in law on which the application is based, and it is necessary, in order for an action to be admissible, that the basic legal and factual particulars relied on be indicated, at least in summary form, coherently and intelligibly in the text of the application itself.

106

Whilst the body of the application may be supported and supplemented on specific points by references to extracts from documents annexed thereto, a general reference to other documents, even those annexed to the application, cannot make up for the absence of the essential arguments in law which, in accordance with the abovementioned provisions, must appear in the application. Furthermore, it is not for the Court to seek and identify in the annexes the pleas and arguments on which it may consider the action to be based, since the annexes have a purely evidential and instrumental function (see judgment of 17 September 2007, Microsoft v Commission, T‑201/04, EU:T:2007:289, paragraph 94 and the case-law cited). Consequently, in the present case, the Court can take into consideration Annexes A 2 and A 3 to the application only in so far as they support or supplement pleas or arguments expressly set out by the applicants in the body of the application and in so far as it is possible for the Court to determine precisely what are the matters they contain that support or supplement those pleas or arguments (judgment of 17 September 2007, Microsoft v Commission, T‑201/04, EU:T:2007:289, paragraph 99).

107

As regards, more particularly, Annex A 2 to the application, it must be held, contrary to what the Commission submits, that the essence of the applicants’ arguments is indeed contained in the body of the application and that the elements set out in that annex merely support and supplement, on specific points, the pleas and arguments contained in the body of the application, which it is easy for the Court to identify.

108

For example, the applicants stated, in paragraph 103 of the application, that the contested decision acknowledged that patent dispute settlements between competitors had in general a legitimate objective and that certain Member States encouraged the seeking of settlements. In paragraph 24 of Annex A 2 to the application, to which paragraph 103 of the application refers, it is likewise stated that there is a strong public interest in the settlement of disputes, that many national legal systems encourage, or even require, the seeking of a settlement as a pre-condition for bringing court proceedings, and that the contested decision, in that it constitutes a restriction on the right to reach a settlement, runs counter to that policy and results in the imposition of unnecessary costs on the parties and the courts. Since the applicants therefore put forward, in paragraph 24 of Annex A 2 to the application, arguments which merely support and supplement the elements expressly relied on in the body of the application, those arguments are admissible.

109

With regard to paragraphs 29 and 818 of the application, in connection with which the Commission claims that the applicants merely referred to Sir Jacobs’ opinion, it should be noted that the applicants set out in detail in paragraphs 816 to 822 of the application the reasons why the Commission could not, in their view, impose a fine on them on account of the unprecedented and unforeseeable nature of the position adopted by the Commission and that paragraphs 70 and 76 of Annex A 2 to the application do not contain new arguments or discussions in that regard.

110

As regards paragraph 147 of the application, in which the applicants state that the approach which they propose to adopt in order to identify settlement agreements contrary to the provisions of Article 101 TFEU is consistent with the position adopted by the judgment of the Supreme Court of the United States of 17 June 2013, Federal Trade Commission v. Actavis (570 U. S. (2013), ‘the Actavis judgment’), it must be observed that that paragraph refers, by means of footnote 153, to paragraphs 32 and 33 of Annex A 2. However, in paragraph 32 of that annex, the applicants merely support that argument and, in paragraph 33 of that annex, they confine themselves to arguing that the scope of the Actavis judgment cannot be limited to a national context unconnected with EU law and that the view of the Supreme Court of the United States deserves particular respect, given its reputation and experience in competition law. Consequently, those arguments are admissible.

111

As regards Annex A 3 to the application, it must be held, as the Commission argues, that, although, in paragraph 11 of the application, the applicants maintain that the Commission’s attitude is not neutral with regard to intellectual property rights, they nevertheless merely refer to paragraphs 8, 15, 31, 34 and 41 of Annex A 3 to the application, in which Ms Macken puts forward arguments relating to (i) the need to draw a distinction between the various areas of intellectual property, (ii) the fact that the granting of a monopoly over patents is the quid pro quo for the disclosure of the invention to the public, (iii) the erroneous use of the concept of ‘market exclusivity’ by the Commission in the contested decision and (iv) a misinterpretation by the Commission of the EPC. Consequently, those arguments are not admissible, with the exception of that relating to the fact that the granting of a monopoly over patents is the quid pro quo for the disclosure of the invention to the public. In paragraph 67 of the application, the applicants referred to the fact that the Commission ‘completely disregarded that essential aspect of patents, namely their publication for the purpose of disseminating inventions’.

112

Similarly, in paragraph 68 of the application, the applicants claim that the Commission cited in a biased way the statements of the Court of Appeal (England & Wales) (Civil division) in the judgment of 9 May 2008 dismissing Servier’s appeal against the judgment of the High Court of Justice (England & Wales), Chancery Division (Patents Court), and criticise the Commission for not taking into account the report of Professor S. annexed to their response to the statement of objections in that regard. They also refer to paragraphs 113 to 117 of Annex A 3 to the application. In those paragraphs, Ms Macken does not merely supplement or expand on those arguments, but puts forward arguments relating to the Commission’s alleged misuse of evidence which allowed it to conclude that the 947 patent was invalid. She thus sets out arguments seeking to call into question the Commission’s interpretation of the statement by the applicant’s Patent Director referred to in recitals 127 and 185 of the contested decision, of the statement by Krka’s legal adviser referred to in recital 883 of that decision and of the statement by Krka’s sales manager for western Europe referred to in paragraph 895 of that decision. Consequently, those arguments are not admissible.

113

With regard to paragraph 76 of the application, it is also necessary to hold, as the Commission points out, that, although the applicants stated in footnote 79 of the application that the sending of letters of formal notice was lawful, they merely referred to paragraphs 58 to 67 of Annex A 3 to the application to explain the grounds supporting a finding that the sending of such letters is lawful. The arguments put forward in Annex A 3 to the application on that point are therefore not admissible.

114

In paragraph 103 of the application, the applicants merely pointed out that the contested decision acknowledged that patent dispute settlements between competitors had in general a legitimate objective and that certain Member States encouraged the seeking of settlements. However, paragraphs 50 to 54 of Annex A 3 to the application, to which paragraph 103 of the application refers (footnote 113), criticise the Commission for not having adequately assessed the settlement practices used worldwide, which are set out in detail.

115

With regard to paragraph 46 of the reply, the applicants argue that the idea that it would be preferable for any litigation to result in a judgment is ‘contrary to current thinking in relation to judicial proceedings’, referring to paragraph 112 of Annex A 3 to the application, which states that the Commission’s approach is contrary to Directive 2008/52/EC of the European Parliament and of the Council of 21 May 2008 on certain aspects of mediation in civil and commercial matters (OJ 2008 L 136, p. 3). Since those arguments do not merely support or supplement the elements expressly relied upon in the body of the application, they are inadmissible.

116

Finally, in paragraph 262 of the application, the applicants stated that it was of primary importance for Teva to be among the first generic undertakings to enter the market in the United Kingdom, referring to paragraph 90 of Annex A 3 to the application. Contrary to what the Commission maintains, in that paragraph of Annex A 3 to the application, the applicants have merely supported and supplemented that assertion by setting out the reasons why a generic undertaking has an interest in entering a market only if it is among the first entrants. Accordingly, the arguments put forward in Annex A 3 to the application on that point are admissible.

B. Substance

1.   Infringement of the principle of impartiality and of the right to sound administration

(a)   Arguments of the parties

(b)   Findings of the Court

119

As a preliminary point it should be noted that the guarantees afforded by the EU legal order in administrative proceedings include, in particular, the principle of sound administration, affirmed in Article 41 of the Charter of Fundamental Rights, which entails the duty of the competent institution to examine carefully and impartially all the relevant aspects of the individual case (judgments of 30 September 2003, Atlantic Container Line and Others v Commission, T‑191/98 and T‑212/98 to T‑214/98, EU:T:2003:245, paragraph 404, and of 27 September 2012, Shell Petroleum and Others v Commission, T‑343/06, EU:T:2012:478, paragraph 170). That requirement of impartiality encompasses, on the one hand, subjective impartiality, in so far as no member of the institution concerned who is responsible for the matter may show bias or personal prejudice, and, on the other hand, objective impartiality, in so far as there must be sufficient guarantees to exclude any legitimate doubt as to bias on the part of the institution concerned (see judgment of 11 July 2013, Ziegler v Commission, C‑439/11 P, EU:C:2013:513, paragraph 155 and the case-law cited). It is also important to note that the Commission may not be classified as a ‘tribunal’ within the meaning of Article 6 of the Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘the ECHR’), and it is thus Article 41 of the Charter of Fundamental Rights, not Article 47 thereof, which governs the administrative procedure relating to restrictive practices before the Commission (see judgment of 11 July 2013, Ziegler v Commission, C‑439/11 P, EU:C:2013:513, paragraph 154 and the case-law cited).

120

The applicants rely on two judgments of the European Court of Human Rights (‘the ECtHR’). In the first place, the applicants rely on the judgment of the ECtHR of 25 March 2008, Vitan v. Romania (CE:ECHR:2008:0325JUD004208402), relating to the presumption of innocence, enshrined in Article 6(2) of the ECHR, in which the ECtHR found a breach of that provision, because the prosecutor in charge of the criminal investigation relating to the applicant had stated at a press conference that the applicant was guilty of trading in influence, although the applicant’s guilt had not yet been lawfully established, and the prosecutor had not ‘qualified his remarks or taken care to place them in the context of the proceedings pending against the applicant’ (paragraphs 70 and 71). In that respect, it is important to recall that, according to the case-law of the ECtHR, the principle of the presumption of innocence may be infringed not only by a court or tribunal but also by other public authorities, that it is appropriate to emphasise the importance of the choice of words used by State officials in the statements they make before a person has been tried and convicted of an offence and that what matters for the purposes of the application of Article 6(2) of the ECHR is the actual meaning of the statements in question and not their literal form (see ECtHR, 15 March 2011, Begu v. Romania, CE:ECHR:2011:0315JUD002044802, paragraph 126 and the case-law cited). The ECtHR nevertheless acknowledges that Article 6(2) of the ECHR cannot prevent, in the light of Article 10 thereof, which protects freedom of expression, the authorities from informing the public about criminal investigations in progress, but it requires that they do so with all the discretion and circumspection necessary if the presumption of innocence is to be respected (ECtHR, 10 February 1995, Allenet de Ribemont v. France, CE:ECHR:1995:0210JUD001517589, paragraph 38).

121

In the second place, the applicants rely on the judgment of the ECtHR of 16 September 1999, Buscemi v. Italy (CE:ECHR:1999:0916JUD002956995), in which the ECtHR found that there had been a breach of Article 6(1) of the ECHR and of the right of every person to a fair hearing by an independent and impartial tribunal, where the President of the court publicly used expressions which implied that he had already formed an unfavourable view of the applicant’s case before presiding over the court that had to decide it (paragraphs 68 and 69). In that judgment, the ECtHR also recalled that the judicial authorities were required to exercise maximum discretion with regard to the cases with which they deal in order to preserve their image as impartial judges and that that discretion should dissuade them from making use of the press, even when provoked (paragraph 67). It should be recalled, however, that in the case-law of the EU Courts the Commission cannot be described as a ‘court’ within the meaning of Article 6 of the ECHR (see paragraph 119 above).

122

The applicants rely, moreover, on the judgment of 8 July 2008, Franchet and Byk v Commission (T‑48/05, EU:T:2008:257, paragraphs 210 to 219), in which the General Court found, within the context of an action for compensation, an infringement by the European Anti-Fraud Office (OLAF) of the principles of the presumption of innocence and sound administration and of its obligation of confidentiality, in that it provoked the disclosure in the press of sensitive elements of ongoing investigations and stated that the applicants were likely to have committed a ‘“vast enterprise of looting” of European Union funds’ (paragraph 216).

123

Moreover, the Court has already provided clarification concerning the duty of impartiality and the principle of sound administration which the Commission is required to observe in competition law cases. Accordingly, in the judgment of 20 March 2002, ABB Asea Brown Boveri v Commission (T‑31/99, EU:T:2002:77, paragraphs 99 to 107), the Court rejected a plea alleging infringement of the principle of sound administration in a case in which the applicant had, at its hearing before the Commission, been subject to a derogatory remark concerning its reputation and to a series of tendentious questions about facts which it no longer disputed, on the part of a Commission official dealing with the case which led to the contested decision, and in which the same official had, at a conference on issues of competition law held before the adoption of the Commission’s decision, expressed his views using a quotation casting discredit on the applicant’s activities. Indeed, while acknowledging that those remarks showed regrettable behaviour and language on the part of a member of the team responsible for dealing with the case and recalling that the Commission’s Director-General of the Directorate-General for Competition had apologised to the applicant following the remark made at the conference, the Court held that those remarks were not of such a kind as to cast doubt on the degree of care and impartiality with which the Commission conducted its investigation into the infringement at issue and that the regrettable conduct on the part of a member of the team dealing with a case did not in itself vitiate the legality of the decision adopted by the College of Commissioners.

124

As regards the combining by the Commission of the functions of investigation and punishment of infringements of the competition rules, the Court of Justice has ruled that it was not in itself contrary to Article 6 of the ECHR as interpreted by the ECtHR (see, to that effect, judgment of 18 July 2013, Schindler Holding and Others v Commission, C‑501/11 P, EU:C:2013:522, paragraphs 33 and 34) and the General Court has held that it did not constitute an infringement of the requirement of impartiality (see, to that effect, judgment of 27 June 2012, Bolloré v Commission, T‑372/10, EU:T:2012:325, paragraphs 65 to 67). The absence of separation between the functions of investigation and punishment within the Commission does, however, entail a particular responsibility on the part of the members of that institution, in particular on the part of the Commissioner responsible for competition, to avoid any bias in the investigation and conduct of infringement proceedings, since they have the power to punish the undertakings concerned at the end of those proceedings.

125

The Court has, moreover, held that the Commission’s assertion that it is determined that the members of anticompetitive cartels should not escape, on procedural grounds, the penalties applicable under EU law is not an infringement of the principle of impartiality but merely the assertion of a clear intention, wholly consistent with the task entrusted to the Commission, of making good, on a case-by-case basis, the procedural irregularities found, in order not to undermine the effectiveness of EU competition law (judgment of 27 June 2012, Bolloré v Commission, T‑372/10, EU:T:2012:325, paragraphs 73 and 74).

126

It should also be borne in mind that the EU judicature — in order to reject a plea alleging infringement of the right to a fair trial or of the principle of sound administration, based on the public positions adopted by the Commission or one of its representatives during the administrative procedure — has already relied on the ground that there was nothing in the Court’s file to support the presumption that the contested decision would not have been taken, or would have been drawn up in a different way, if the public statements which are the subject matter of this submission had not been made (see, to that effect, judgments of 16 December 1975, Suiker Unie and Others v Commission, 40/73 to 48/73, 50/73, 54/73 to 56/73, 111/73, 113/73 and 114/73, EU:C:1975:174, paragraph 91, and of7 July 1994, Dunlop Slazenger v Commission, T‑43/92, EU:T:1994:79, paragraph 29). According to the case-law, it is thus for the applicant to produce at least some indicia to support such a conclusion (judgment of 15 March 2006, BASF v Commission, T‑15/02, EU:T:2006:74, paragraph 606).

127

It is also important to recall that the functioning of the Commission is governed by the principle of collegiate responsibility laid down in Article 250 TFEU, which is based on the equal participation of the Commissioners in the adoption of decisions, from which it followed in particular that decisions should be the subject of collective deliberation and that all the members of the College of Commissioners should bear collective responsibility at political level for all decisions adopted. This is particularly so in the case of acts which are expressly described as decisions which the Commission finds necessary to adopt with regard to undertakings for the purpose of ensuring observance of the competition rules and by which it finds an infringement of those rules, issues directions to those undertakings and imposes pecuniary sanctions upon them. The operative part of, and the statement of reasons for, a decision constitute an indivisible whole and it is therefore for the College of Commissioners alone to adopt both the operative part and the statement of reasons, in accordance with the principle of collegiate responsibility (judgment of 27 September 2012, Heijmans Infrastructuur v Commission, T‑359/06, not published, EU:T:2012:489, paragraphs 126 and 127). The Court has also held, in matters relating to State aid, that the expression of an opinion by the Commissioner responsible for competition matters on a procedure in progress is, in so far as it is strictly personal and without prejudice, attributable to that Commissioner alone and does not predetermine the position that the College of Members of the Commission will adopt at the end of the procedure (judgment of 8 July 1999, Vlaamse Televisie Maatschappij v Commission, T‑266/97, EU:T:1999:144, paragraphs 49 and 54). Moreover, it cannot be assumed that the Commissioners were constrained in their freedom of assessment by a misplaced feeling of solidarity towards their colleague with responsibility for competition matters (judgment of 15 March 2006, BASF v Commission, T‑15/02, EU:T:2006:74, paragraph 610).

128

As regards objective impartiality, which refers to the fact that the institution must provide sufficient guarantees to exclude any legitimate doubt, it should be pointed out that the Commission, as it stated at the hearing in reply to a question from the Court, has adopted several internal documents requiring it to comply with certain rules when communicating publicly. In particular, the Code of Conduct for Commissioners (C(2011) 2904), adopted in 2011, provides in Article 1.7 thereof that, in accordance with the principle of collegiality, Members of the Commission are to refrain from making any comment that would call into question a decision taken by the Commission and are also to refrain from disclosing what is said at meetings of the Commission. Moreover, the Annex to Decision 2000/633/EC, ECSC, Euratom of 17 October 2000 amending its Rules of Procedure (OJ 2000 L 267, p. 63), entitled ‘Code of good administrative behaviour for Staff of the European Commission in their relations with the public’, states in its provisions that ‘quality service calls for the Commission and its staff to be courteous, objective and impartial’, and in paragraph 2 thereof, concerning objectivity and impartiality, that ‘staff shall always act objectively and impartially, in the [European Union] interest and for the public good’ and that ‘they shall act independently within the framework of the policy fixed by the Commission and their conduct shall never be guided by personal or national interest or political pressure’. Similarly, the Code of Ethics and Integrity of DG Competition, adopted on 28 June 2010, recommends that its staff, with regard to freedom of expression, avoid any discussion of a case concerning which the Commission has not adopted an official position and, with regard to contacts with the media, avoid talking about a case which is still the subject of investigation and in respect of which the Commission has not adopted an official position.

129

The applicants claim that the Ombudsman has already established an instance of maladministration concerning the Commissioner responsible for competition who was in office when the contested decision was adopted, in so far as he had, as in the present case, made public statements suggesting that he had already reached a conclusion before the end of the investigation.

130

In that regard, it should be recalled that a finding by the Ombudsman of an ‘act of maladministration’ is not binding on the Courts of the European Union and can constitute nothing more than an indication of infringement, by the institution concerned, of the principle of sound administration. Proceedings before the Ombudsman, who does not have the power to make binding decisions, are for EU citizens an extrajudicial alternative remedy to an action before those Courts, which meets specific criteria and does not necessarily have the same objective as legal proceedings (judgment of 25 October 2007, Komninou and Others v Commission, C‑167/06 P, not published, EU:C:2007:633, paragraph 44). A fortiori, interpretations of EU law by the Ombudsman are incapable of binding the Courts of the European Union.

131

In the present case, as regards subjective impartiality, which relates to the fact that a member of the institution concerned who is responsible for the case must not show bias or personal prejudice, the applicants criticise each of the consecutive Commissioners for Competition, Ms N. Kroes and Mr J. Almunia, for having made, on three occasions, public comments on the outcome of the investigation relating to the applicants during the administrative procedure. As the applicants pointed out at the hearing, those two Commissioners were still in office within the Commission when the contested decision was adopted, were involved in adopting it and were directly responsible for the investigation of the case at various times. Moreover, the contested decision is signed by Mr Almunia.

132

In the first place, it is apparent from the file that, at the press conference on the presentation of the conclusions of the pharmaceutical sector inquiry report, Ms Kroes stated that ‘unfortunately, the report confirm[ed] that there [we]re competition problems in the pharma sector’, that ‘company practices [we]re a significant factor behind them’ and that, ‘in particular, the report conclude[d] that makers of original medicines [we]re actively trying to delay the entry of generic medicines onto their markets’ (speech published on the DG Competition website). According to the applicants, Ms Kroes further stated that ‘overall it is indeed a conclusion that there [wa]s something rotten in the state’ (extract from the website of the EU Observer online newspaper). The Commission submits in the rejoinder that those remarks were merely reported by a journalist and that the article confirms that the term ‘rotten’ related to the sector inquiry and not to the applicants. At the same press conference, the same Commissioner for Competition referred, in a separate part entitled ‘Competition cases and scrutiny’, to the opening of proceedings against the applicants and certain generic undertakings, stating that ‘it concern[ed] suspected breaches of the [FEU] Treaty’s rules on both restrictive business practices (Article [101 TFEU]) and abuse of a dominant market position (Article [102 TFEU])’, that ‘the case w[ould] look at the agreements between Servier and a number of generic companies’ and that ‘these agreements [had] affected the entry of generic competitors against perindopril, a leading drug that combat[ed] heart-disease and high blood pressure’. The Commissioner for Competition therefore clearly distinguished the results of the sector inquiry from the decision to initiate proceedings against the applicants. As regards the latter, the Commissioner for Competition was careful to point out that potential infringements of the competition rules were at issue. The mere circumstance that she referred, in the following sentence, to the fact that the agreements in question had affected the entry of generic medicines into the market cannot, in itself, imply that she considered that an infringement of the competition rules had taken place, in the light of the context referred to in the preceding sentence. At that press conference, the Commissioner for Competition therefore merely informed the public about investigations in progress, with the discretion and circumspection necessary if the presumption of innocence is to be respected.

133

In the second place, on 8 October 2012, during a speech to the European Parliament presenting the Commission’s competition policy work programme for 2013-2014, Mr Almunia referred, in particular, to the procedure relating to the agreements at issue, stating that, ‘in the pharmaceutical industry, … and Servier [had] received [the Commission’s] objections before the summer’, that he was ‘concerned that these companies misused their patents to keep markets closed to cheap generic medicines’ and that he ‘hope[d] that the decisions [which would be] adopt[ed] — hopefully in 2013 — [would] change current practices by some players in the industry that le[ft] a lot to be desired’ (speech published on the DG Competition website). By stating that the Commission had sent a statement of objections to the applicants and to other undertakings in the present case and in another case and that decisions would be adopted in 2013, the Commissioner did not fail to fulfil his obligation of impartiality, however, and merely informed Parliament about investigations in progress, with the discretion and circumspection necessary if the presumption of innocence is to be respected. Indeed, it is necessary to recall the preliminary nature of the statement of objections, the function of that document, as defined by the European Union regulations, being to give undertakings all the information necessary to enable them properly to defend themselves, before the Commission adopts a final decision (see judgment of 27 September 2012, Koninklijke Wegenbouw Stevin v Commission, T‑357/06, EU:T:2012:488, paragraph 43 and the case-law cited). Although the Commission, under Article 27(1) of Regulation No 1/2003, must thus base its final decision only on objections on which the parties have been able to comment, it is not required to reproduce all the evidence set out in the statement of objections, particularly if that evidence appears insufficient. It is therefore inherent in the nature of the statement of objections that it is provisional and subject to amendments to be made by the Commission in its further assessment on the basis of the observations submitted to it by the parties and subsequent findings of fact (judgment of 10 July 2008, Bertelsmann and Sony Corporation of America v Impala, C‑413/06 P, EU:C:2008:392, paragraph 63). Moreover, following communication of the statement of objections, by which the Commission considers on first analysis that an infringement has been committed, the duty of circumspection of the Commissioner for Competition need not necessarily be so broad, since that Commissioner may, in public statements, set out with all due caution, as regards a provisional assessment, the allegations made against an undertaking at that stage of the procedure.

134

In the third place and finally, it is apparent from the file that, on 12 April 2013, Mr Almunia stated, in a speech to the American Bar Association in Washington which was transcribed in the press, that ‘the Commission … [would] decide in the coming months on the legality of agreements between pharmaceutical undertakings seeking to delay the entry into the market of cheaper generic medicines’ and that ‘the results of the sector inquiry will be reflected in decisions in the … and Servier cases’ (extract from the MLex website). It should be emphasised that that article only indirectly reports the remarks of the Commissioner. Moreover, even if the Commissioner for Competition actually made those remarks, they can be interpreted only as meaning that there was a possibility that a decision might be adopted in the case at issue (see, to that effect and by analogy, judgment of 8 July 1999, Vlaamse Televisie Maatschappij v Commission, T‑266/97, EU:T:1999:144, paragraph 53). Therefore, the Commissioner for Competition merely informed the public about investigations in progress, with the discretion and circumspection necessary if the presumption of innocence is to be respected. In any event, it must be borne in mind that those remarks were merely the expression of the Commissioner for Competition’s opinion on an ongoing procedure, and were attributable to that Commissioner alone and did not predetermine the position that the College of Members of the Commission adopted at the end of the procedure (see paragraph 127 above).

135

Consequently, there is no need to examine the applicants’ argument that the contested decision would have been different in the absence of those statements by the Commissioners.

136

In support of this plea, the applicants also criticise the Commissioner for Competition and his cabinet for not having been present during most of the hearing. However, the fact, emphasised at the hearing by the applicants, that Mr Almunia did not attend their hearing before the Commission and was represented by a member of his cabinet is not such as to establish that the decision to impose a penalty had already been adopted, in principle, even before that hearing. Moreover, there is no provision requiring the participation of the Commissioner or a member of his cabinet at the hearing. The EU Courts take the view that the principle of proper administration cannot transform into an obligation that which the legislature did not view as being one (see, to that effect, judgment of 27 September 2012, Koninklijke Wegenbouw Stevin v Commission, T‑357/06, EU:T:2012:488, paragraph 242).

137

The applicants also complain that the Commission failed to comply with the applicable rules and standards of evidence, referring to several recitals of the contested decision which they contest in other pleas in their application (distortion of the facts, error in the legal criterion applicable to the classification of an infringement by object, an unreasonable interpretation of the concept of potential competition, etc.). In the reply, they argue that those examples are intended to establish bias vitiating the investigation. As claimed by the Commission, that line of argument of the applicants is, however, indissociable from the question whether the findings of fact made in the contested decision are duly supported by the evidence which the institution has produced and whether the Commission committed errors of law in its analysis (see, to that effect, judgment of 24 October 1991, Atochem v Commission, T‑3/89, EU:T:1991:58, paragraph 39). Consequently, those arguments will be examined subsequently, in the context of the substantive pleas. In any event, it must be pointed out that those arguments are based on mere assertions and are not such as to show that the Commission did in fact pre-judge the outcome of the administrative procedure or lacked objectivity in its investigation (see, to that effect, judgment of 6 July 2000, Volkswagen v Commission, T‑62/98, EU:T:2000:180, paragraph 272).

138

Lastly, the applicants argue that the absence of a re-examination of the case by an internal panel within DG Competition demonstrates the partiality of the contested decision and justifies its annulment on the grounds of infringement of the principle of the presumption of innocence and of Article 41 of the Charter of Fundamental Rights. However, it is important to note that no provision of a regulation or internal rule of the Commission requires that the Commission organise a re-examination of every case by an internal panel and to recall that the principle of proper administration cannot transform into an obligation that which the legislature did not view as being one (see paragraph 136 above). A peer review system was indeed set up within DG Competition in 2004. Nevertheless, it is apparent from a document published in September 2011 by the Commission, entitled ‘Procedure for the application of Articles 101 and 102 TFEU: key players and the balance of power’, that the Director-General of DG Competition determines, in agreement with the Commissioner for Competition, the cases in which that internal panel is organised, that the decision to form such a panel and its composition are not made public and that the peer review of a case under no circumstances involves the parties to the proceedings or any other third party. The organisation of such a re-examination by DG Competition is therefore not required in all cases, with the result that the Commission cannot be criticised for not having organised such a re-examination in the present case.

139

The plea must therefore be rejected.

2.   The lack of effective consultation of the Advisory Committee on Restrictive Practices and Dominant Positions

(a)   Arguments of the parties

(b)   Findings of the Court

142

Article 14(1) of Regulation No 1/2003, which is contained in Chapter IV on cooperation between the Commission and the competition authorities and courts of the Member States, provides that ‘the Commission shall consult an Advisory Committee on Restrictive Practices and Dominant Positions prior to the taking of any decision under Articles 7, 8, 9, 10, 23, Article 24(2) and Article 29(1)’ of that regulation. Article 14(2) of Regulation No 1/2003 provides that ‘for the discussion of individual cases, the Advisory Committee shall be composed of representatives of the competition authorities of the Member States’. Article 14(3) of Regulation No 1/2003 stipulates that the Advisory Committee is to deliver a written opinion on the Commission’s preliminary draft decision and Article 14(5) of that regulation provides that ‘the Commission shall take the utmost account of the opinion delivered by the Advisory Committee’ and ‘shall inform the Committee of the manner in which its opinion has been taken into account’. Furthermore, ‘at the request of one or several members, the positions stated in the opinion shall be reasoned’ (Article 14(3) of Regulation No 1/2003). Paragraph 58 of the Commission Notice on cooperation within the Network of Competition Authorities (OJ 2004 C 101, p. 43, ‘the Notice on cooperation within the Network of Competition Authorities’) provides that ‘the Advisory Committee is the forum where experts from the various competition authorities discuss individual cases and general issues of [EU] competition law’.

143

As regards procedure, Article 14(3) of Regulation No 1/2003 provides that the consultation of the Advisory Committee ‘may take place at a meeting convened and chaired by the Commission, held not earlier than 14 days after dispatch of the notice convening it, together with a summary of the case, an indication of the most important documents and a preliminary draft decision’. Nevertheless, ‘where the Commission dispatches a notice convening the meeting which gives a shorter period of notice than those specified above, the meeting may take place on the proposed date in the absence of an objection by any Member State’. Paragraph 66 of the Notice on cooperation within the Network of Competition Authorities states that ‘the Council Regulation allows for the possibility of the Member States agreeing upon a shorter period of time between the sending of the invitation and the meeting’. Article 14(3) of Regulation No 1/2003 provides, moreover, that the Advisory Committee ‘may deliver an opinion even if some members are absent and are not represented’. Article 14(4) of Regulation No 1/2003 provides, lastly, that ‘consultation may also take place by written procedure’, but that ‘if any Member State so requests, the Commission shall convene a meeting’. According to that provision, ‘in case of written procedure, the Commission shall determine a time limit of not less than 14 days within which the Member States are to put forward their observations for circulation to all other Member States’.

144

The document entitled ‘Working Arrangements for the Antitrust Advisory Committee’ of 19 December 2008, adduced by the Commission on 6 November 2015 in response to a measure of organisation of procedure, sets out the various steps leading up to the consultation of the Advisory Committee and, in particular, those allowing the national competition authorities to assess the case as the investigation progresses.

145

In the first place, it should be noted, in that respect, that, under Article 11(2) of Regulation No 1/2003, ‘the Commission shall transmit to the competition authorities of the Member States copies of the most important documents it has collected with a view to applying Articles 7, 8, 9, 10 and Article 29(1)’ of that regulation and, ‘at the request of the competition authority of a Member State, the Commission shall provide it with a copy of other existing documents necessary for the assessment of the case’. Article 11(6) of Regulation No 1/2003 provides, in addition, that ‘the initiation by the Commission of proceedings for the adoption of a decision under Chapter III shall relieve the competition authorities of the Member States of their competence to apply Articles [101 and 102 TFEU]’ and that, ‘if a competition authority of a Member State is already acting on a case, the Commission shall only initiate proceedings after consulting with that national competition authority’. Under those provisions, the Commission is to immediately deliver to the national competition authorities, after their notification to the undertaking concerned or their reception, the initial decision initiating the proceedings, the statement of objections addressed to that undertaking, the latter’s response to that statement of objections and the other most important documents relating to the case (see paragraphs 6 and 7 of the Working Arrangements for the Antitrust Advisory Committee).

146

In the second place, the Working Arrangements for the Antitrust Advisory Committee provide, in paragraphs 33 to 36, that, for each case in which the Commission addresses a statement of objections to an undertaking, the Commission must, not later than 45 days following the notification of the statement of objections to the parties concerned, appoint one of the national competition authorities as the rapporteur in the case (‘the NCA rapporteur’), on a rotating basis that corresponds to the rotating presidencies of the Council of the European Union, unless it is necessary to choose another national competition authority in the interests of objectivity, in which case the Commission may, subject to the agreement of the first national competition authority, choose the next authority on that list of rotating presidencies (paragraphs 28, 33 and 34). The NCA rapporteur, who is responsible for helping the other national competition authorities to understand the case and for informing them of the significant procedural steps in the administrative proceedings, works to that end in close cooperation with the Commission (paragraphs 40 and 42). The Working Arrangements for the Antitrust Advisory Committee also recommend that the NCA rapporteur should circulate a list of key questions in the case not later than five days prior to the Advisory Committee meeting (paragraph 44(i)) and should present the case and its issues at the beginning of the Advisory Committee meeting (paragraph 44(ii)).

147

In the third place, according to Article 11(1) of Commission Regulation (EC) No 773/2004 of 7 April 2004 relating to the conduct of proceedings by the Commission pursuant to Articles [101 and 102 TFEU] (OJ 2004 L 123, p. 18), ‘the Commission shall give the parties to whom it has addressed a statement of objections the opportunity to be heard before consulting the Advisory Committee referred to in Article 14(1) of Regulation … No 1/2003’. Article 14(3) of Regulation No 773/2004 provides, moreover, that ‘the Commission shall invite the competition authorities of the Member States to take part in the oral hearing’ and that ‘it may likewise invite officials and civil servants of other authorities of the Member States’. Paragraph 12 of the Working Arrangements for the Antitrust Advisory Committee states that the participation of the national competition authorities in the oral hearing of a case is useful for the efficient functioning of the Advisory Committee. However, no provision stipulates that the NCA rapporteur is to play a particular role at the hearing.

148

According to the case-law on the corresponding provisions of Regulation No 17 of the Council of 6 February 1962, First Regulation implementing Articles [101 and 102 TFEU] (OJ, English Special Edition 1959-1962, p. 87), which was succeeded by Regulation No 1/2003, consultation of the Advisory Committee is an essential procedural requirement, breach of which affects the legality of the Commission’s final decision if it is proved that the failure to comply with the rules on consultation prevented the Advisory Committee from delivering its Opinion in full knowledge of the facts. The substance of the obligations under the provisions governing the consultation of the Advisory Committee, and the question whether or not they constitute essential requirements, must therefore be determined in each case in the light of that purpose of enabling the committee to carry out its advisory task in full knowledge of the facts (see, to that effect, judgments of 10 July 1991, RTE v Commission, T‑69/89, EU:T:1991:39, paragraphs 21 and 23, and of 15 March 2000, Cimenteries CBR and Others v Commission, T‑25/95, T‑26/95, T‑30/95 to T‑32/95, T‑34/95 to T‑39/95, T‑42/95 to T‑46/95, T‑48/95, T‑50/95 to T‑65/95, T‑68/95 to T‑71/95, T‑87/95, T‑88/95, T‑103/95 and T‑104/95, EU:T:2000:77, paragraph 742).

149

In that regard, it was considered, with regard to the documents to be sent to the Advisory Committee, that, although that consultation falls within the framework of cooperation between the Commission and the Member States and is not intended to set up adversarial proceedings against the undertakings concerned, the committee must have, in particular, entirely objective information on the views and essential arguments expressed by the undertakings concerned in their comments on all the objections raised against them by the Commission once the investigation is completed. The minutes of the hearing are thus, in principle, among the ‘most important documents’ within the meaning of Article 10(5) of Regulation No 17, and must therefore be sent to the Advisory Committee when it is convened. However, it is not an essential procedural requirement that the minutes of the hearing be sent to the Advisory Committee unless, in a specific case, it proves necessary in order to enable the committee to deliver its Opinion in full knowledge of the facts, that is to say without being misled in a material respect by inaccuracies or omissions. That is not the case when the minutes of the hearing do not contain any important new information not contained in the written comments, accompanying the notice convening the Advisory Committee, made by the undertaking concerned in reply to the statement of objections. In such an event, the fact that the Commission did not send the minutes of the hearing to the Advisory Committee when it was convened does not affect the applicant’s right to a fair hearing and has no repercussions on the outcome of the consultation procedure. The omission cannot, therefore, render the whole administrative procedure invalid and thereby call into question the legality of the final decision (judgment of 10 July 1991, RTE v Commission, T‑69/89, EU:T:1991:39, paragraphs 21 to 23).

150

Moreover, it was held that the fact that the Commission did not provide the exact amount of a proposed fine to the Advisory Committee did not constitute a breach of the essential procedural requirement to consult the Advisory Committee, since that committee was given all the essential information required to draw up an opinion concerning fines. The Advisory Committee must be kept informed only of the proposed criteria for imposing the fine (see, to that effect, judgment of 15 March 2000, Cimenteries CBR and Others v Commission, T‑25/95, T‑26/95, T‑30/95 to T‑32/95, T‑34/95 to T‑39/95, T‑42/95 to T‑46/95, T‑48/95, T‑50/95 to T‑65/95, T‑68/95 to T‑71/95, T‑87/95, T‑88/95, T‑103/95 and T‑104/95, EU:T:2000:77, paragraphs 747 and 748). Paragraph 23 of the Working Arrangements for the Antitrust Advisory Committee thus points out the need to ensure the confidentiality of exchanges of views within the committee, in particular about the level of fines. Paragraph 24 of the Working Arrangements for the Antitrust Advisory Committee provides that, with respect to fixing the level of the fine, the Commission should distribute at the meeting of the Advisory Committee a document explaining the method of calculation chosen, with specific reference to 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 Guidelines on the method of setting fines’), that members of the Advisory Committee may request additional time to examine that document and that, at the end of the meeting, that document is to be returned to the Commission.

151

In the present case, in the first place, the applicants submit that the Commission did not effectively consult the Advisory Committee, based on the failure to send the part of the preliminary draft decision relating to the fines and the responses of the undertakings to the statement of objections, on the short notice period for the transmission of the contested preliminary draft decision to its members, on the omissions contained in the summary of the preliminary draft decision sent to the national competition authorities and on the insufficient reasoning for the Advisory Committee’s opinion. Those arguments must be examined in the light of the documents in the file and, in particular, the factual details provided by the Commission on 6 November 2015, in response to the abovementioned measure of organisation of procedure, and at the hearing.

152

As regards the applicants’ argument relating to the failure to send the part of the preliminary draft decision concerning the fines, the applicants withdrew it at the hearing, and formal notice of this was taken in the minutes of the hearing. Although, at the hearing, the applicants nevertheless argued that the national competition authorities had not received notification of the method of calculating the amount of the fine at the meetings of the Advisory Committee, that criticism has no basis in fact, since it is apparent from the file that, on 3 July 2014, Chapter 10, concerning the fines, a chapter containing an explanation of the main elements of that method, was sent by the Commission to the national competition authorities with a reminder of the invitation to the second meeting of the Advisory Committee of 7 July 2014. In that regard, it should be pointed out that the national competition authorities had previously received the responses of the undertakings to the statement of objections, on 23 July 2013, as well as a Letter of Facts, on 19 December 2013, and the replies of the undertakings to that letter, on 13 February 2014. Finally, on 20 May 2014, the Commission sent them a Letter of Facts concerning the imputation of the liability for the infringements and the replies of Mylan, Niche and Unichem to that letter.

153

As regards the notice period for the transmission of the draft decision, it is apparent from the file that the Commission sent that draft decision to the national competition authorities of the Member States in three steps: Chapters 1 to 4 were sent on 12 June 2014 with the invitation to the first meeting of the Advisory Committee on 30 June 2014, Chapters 5 to 9 were sent on 20 June 2014 with a summary of the draft decision and Chapter 10, concerning the fines (excluding the exact amount of those fines), was sent on 3 July 2014, with a reminder of the invitation sent on 30 June 2014 to the second meeting of the Advisory Committee of 7 July 2014, which was to cover the entirety of the draft decision. In that regard, it is important to point out that, although, as the applicants claim, on page 109 of the DG Competition manual of procedure for competition policy matters, paragraph 10 provides that two meetings of that Committee are usually organised, one dealing with the substance of the case and the other with the amount of the fines, those provisions nonetheless do not require systematic compliance with that organisational arrangement. Moreover, it is clear from the file that, in the present case, the Commission expressly indicated, in the invitation to the second meeting, sent on 30 June 2014, and in the email of 3 July 2014, that the agenda for the meeting of 7 July 2014 concerned the discussion of the case in its entirety.

154

It is true that that staggered transmission of the documents, which in some cases did not comply with the prescribed period of 14 days, showed some haste on the Commission’s part — probably linked to the fact that it had, as from its transmission of the invitation to the meeting of 30 June 2014, announced to the national competition authorities that it intended to adopt its decision on 9 July 2014 — and that it did not place the members of the Advisory Committee in the best conditions to express their views. However, it must be noted that no national competition authority raised any objection to the dates of these meetings, even though, under Article 14(3) of Regulation No 1/2003, such objections would have prevented the meetings in question from being held. In addition, it is clear from the file that the Commission sent the national competition authorities, on 6 July 2009, the initial decision opening the proceedings, on 31 July 2012, the statement of objections addressed to the undertakings concerned, on 23 July 2013, the responses of the undertakings to the statement of objections, on 19 December 2013, a Letter of Facts, on 13 February 2014, the replies of the undertakings to that letter and, on 20 May 2015, a Letter of Facts concerning the imputation of the liability for the infringements and the replies of Mylan, Niche and Unichem to that letter. In addition, on 25 June 2014, the Commission sent the national competition authorities the draft final report drawn up by the Hearing Officer.

155

Consequently, although it may be regrettable, in particular, that Chapters 5 to 9 of the draft decision, given their length (approximately 600 pages) and complexity, were sent by the Commission to the national competition authorities of the Member States only 10 days before the first meeting of the Advisory Committee, it must be considered, in the light of all the considerations set out in paragraphs 153 and 154 above, that the members of the Advisory Committee were sufficiently informed of the substance of the case and of the content of the draft decision and that, consequently, the Advisory Committee was able to give its opinion in full knowledge of the facts.

156

It must also be noted that, contrary to the submissions of the applicants, neither Article 14(3) of Regulation No 1/2003 nor paragraph 66 of the Commission Notice on cooperation within the Network of Competition Authorities provides that the Commission must obtain the express prior agreement of the competition authorities of the Member States in order to derogate from the prescribed period of 14 days between the transmission of the invitation to the members of the Advisory Committee and the meeting of that committee. Indeed, it follows from Article 14(3) of Regulation No 1/2003 that, where the Commission dispatches a notice convening a meeting which gives a period of notice shorter than that stated above, it is for Member States to raise any objection in that respect, failing which the meeting is to take place on the date set by the Commission. Moreover, as regards the alleged infringement of the principle of sound administration, it is important to recall that that principle cannot transform into an obligation that which the legislature did not view as being one (see paragraph 136 above).

157

As regards the opinion delivered by the Advisory Committee, it must be borne in mind, first, that, under Article 14(6) of Regulation No 1/2003, that opinion is not published as a matter of course, the Court of Justice even holding that the failure to disclose the opinion to the undertakings concerned is not contrary to the principle of the right to a fair hearing (see, to that effect, judgment of 7 June 1983, Musique Diffusion française and Others v Commission, 100/80 to 103/80, EU:C:1983:158, paragraphs 35 and 36), and, secondly, that the provisions of Article 14(3) of Regulation No 1/2003 provide that the positions stated in that opinion are to be reasoned only at the request of one or several members of that committee, which was not the case here. Moreover, Article 27(2) of Regulation No 1/2003 provides that the parties which are the subject of the procedure conducted by the Commission under Article 101 TFEU do not have access to the correspondence exchanged between the Commission and the competition authorities of the Member States or between those competition authorities, including the documents drawn up pursuant to Articles 11 and 14 of that regulation. Furthermore, under Article 28(2) of Regulation No 1/2003, officials and servants of the Commission and of the competition authorities of the Member States are not to disclose information acquired or exchanged by them pursuant to that regulation and of the kind covered by the obligation of professional secrecy, and that obligation also applies to all representatives and experts of Member States attending meetings of the Advisory Committee pursuant to Article 14 of Regulation No 1/2003. Consequently, the applicants cannot effectively argue that the opinion given by the Advisory Committee was insufficiently reasoned. In addition, having regard to the applicable provisions, the fact that the opinion was brief and lacking in detail does not mean that the Advisory Committee did not have at its disposal all the elements necessary to reach a decision in full knowledge of the facts, nor that that committee did not deliver its opinion in full knowledge of the facts, even if its opinion was brief.

158

Lastly, the applicants claim that, since the summary of the preliminary draft decision sent by the Commission to the members of the Advisory Committee was partial and incomplete, the committee was not able to take a decision in full knowledge of the facts. However, it should be recalled, as the Commission argues, that the purpose of that summary is not to identify the arguments put forward by the undertaking concerned in its defence, but to facilitate discussion within the Advisory Committee on the wording of the preliminary draft decision. In any event, in the present case, it is clear from the Commission’s reply to the measure of organisation of procedure that the Commission, in its summary accompanying the preliminary draft decision, presented the main points of that preliminary draft decision, highlighting the most difficult aspects of its analysis (criteria for identifying the existence of a restriction of competition by object, definition of the market, application of Article 102 TFEU). The mere fact that the Commission failed to mention, in that summary, the status of all the disputes relating to the 947 patent, the interpretation of the scope of certain stipulations in the settlement agreements, the facts subsequent to the invalidation of patent 947 by the EPO or the differences between the acquisition of Rolabo’s technology and the technology of another company cannot lead to the conclusion that the Advisory Committee — which had, moreover, a considerable number of documents relating to the case and, in particular, the arguments put forward by the applicants in their observations on the statement of objections and on the Letter of Facts (see paragraphs 152 and 154 above) — was unable to give its opinion in full knowledge of the facts.

159

In the second place, the applicants maintain that the Advisory Committee was not properly consulted, in that only a small number of its members attended its meetings and the NCA rapporteur in the case, who had not been appointed within the prescribed period, was not present at the hearing of the parties and at the second meeting of the Advisory Committee.

160

The applicants complain that the Commission failed to appoint the NCA rapporteur not later than 45 days following the notification of the statement of objections and deliberately chose a national competition authority which had not been present at the hearing.

161

It is common ground that the Working Arrangements for the Antitrust Advisory Committee provide that the appointment of the NCA rapporteur is to be made, in principle, not later than 45 days following the notification of the statement of objections and on the basis of an objective criterion, that is to say, in principle, on a rotating basis that corresponds to the rotating presidencies of the Council (see paragraph 146 above). In the present case, it is apparent from the file that the procedure for appointing the NCA rapporteur commenced on 7 May 2014, that the appointment of the Bundeswettbewerbsbehörde (Federal Competition Authority, Austria, ‘the BWB’) as the NCA rapporteur was made on 3 June 2014 — or after the hearing but well before the meetings of the Advisory Committee — and that it was made on the basis of an objective criterion, that is to say the order of the rotating presidencies of the Council. However, the mere infringement of the 45-day time limit for the appointment of the NCA rapporteur, an infringement acknowledged by the Commission at the hearing, cannot be regarded in the present case as having prevented the Advisory Committee from exercising its functions in full knowledge of the facts. Indeed, the NCA rapporteur’s role in the understanding of the case by the national competition authorities and in providing them with information is particularly important only at the stage of preparing the meetings of the Advisory Committee (see paragraph 164 below) and, in the present case, at that stage of the procedure, the NCA rapporteur had been appointed. With regard to the appointment of the BWB as the NCA rapporteur, it is important to point out, first, that the applicants have not adduced any evidence to show that the appointment was linked to the absence of that national competition authority from the hearing of 15, 16, 17 and 18 April 2013 and, secondly, that the appointment was, in any event, made on the basis of a purely objective criterion, that is to say the order of the rotating presidents of the Council.

162

The applicants also claim that the Advisory Committee could not have reached a decision in full knowledge of the facts, since the NCA rapporteur attended neither the hearing of the parties of 15, 16, 17 and 18 April 2013 nor the Advisory Committee meeting of 7 July 2014. The Commission maintains that no provision is made for the mandatory participation of the NCA rapporteur at the hearing and submits that eight Member States were present at the hearing.

163

It is important to point out that, although paragraph 12 of the Working Arrangements for the Antitrust Advisory Committee states that the participation of the national competition authorities in the oral hearing of a case is useful for the efficient functioning of the Advisory Committee, there is, by contrast, no provision requiring the NCA rapporteur to participate in the hearing, as Article 14(3) of Regulation No 773/2004 provides solely that the competition authorities of the Member States are invited to take part in the oral hearing, especially since all the national competition authorities receive a copy of the minutes of the hearing. It may also be pointed out that, as the Commission argues, the national competition authorities were duly invited to participate in the hearing and eight of them were indeed represented (see, for a case in which the national competition authorities were not invited to the hearing, judgment of 21 September 2017, Feralpi v Commission, C‑85/15 P, EU:C:2017:709, paragraphs 38 to 44). It is also appropriate to recall that the NCA rapporteur’s role in the understanding of the case by the NCAs and in providing them with information is of particular importance before the Advisory Committee but not at the stage of the hearing. The Working Arrangements for the Antitrust Advisory Committee thus recommend that the NCA rapporteur circulates a list of key questions in the case — not later than five days prior to the first Advisory Committee meeting, seeking in particular to determine whether the NCAs can indicate their overall agreement with the preliminary draft decision, whether they have observations on certain aspects and whether they recommend publication of the opinion (paragraph 44(i)) — and presents the case and its issues at the beginning of the first Advisory Committee meeting (paragraph 44(ii)). However, it is clear from the file that the BWB actually had discussions with the Commission in order to draw up the list of questions sent by the Commission to the members of the Advisory Committee for examination and that it participated in the first meeting of the Advisory Committee, during which it presented its report, and it is not disputed by the applicants that, on that occasion, it fully played its role as the NCA rapporteur. Moreover, the mere fact that the Commission sent the other national competition authorities the list of the main issues in the case on the morning of 26 June 2014, that is four days before the first meeting of the Advisory Committee, while the Working Arrangements for the Antitrust Advisory Committee recommend that that period should be five days, is not sufficient to conclude that the Advisory Committee was not in a position to reach a decision in full knowledge of the facts. Contrary to what the applicants claim, the Commission was also not required to appoint another NCA rapporteur, since paragraph 38 of the Working Arrangements for the Antitrust Advisory Committee provides only for the possibility of replacing the natural person representing the national competition authority with another natural person from the same authority where necessary. Therefore, the fact that, in the present case, the BWB attended neither the hearing of the parties on 15, 16, 17 and 18 April 2013 nor, regrettably, the second meeting of the Advisory Committee of 7 July 2015 did not prevent the Advisory Committee from reaching a decision in full knowledge of the facts.

164

As regards the complaint concerning the presence of a limited number of Member States at the meetings of the Advisory Committee, it is apparent from the file that, at the meeting of 30 June 2014, only five national competition authorities were represented (those of the Kingdom of Spain, the Italian Republic, the Republic of Austria, the Republic of Finland and the Kingdom of Sweden) and that, at the meeting of 7 July 2014, only two national competition authorities were represented (those of the Federal Republic of Germany and the Republic of Finland). It indeed follows that a limited number of representatives of Member States participated in the opinion delivered by the Advisory Committee in the present case, since, under paragraphs 20 and 21 of the Working Arrangements for the Antitrust Advisory Committee, only the observations and comments made by members present at the meeting are to be taken into account in the opinion of the Advisory Committee. When asked at the hearing about the reasons for such low participation and the possibility of postponement of the Advisory Committee meetings, the Commission stated that it had known about strikes on the railways and had contacted the members of the committee to ascertain whether they had specific comments but had not considered postponing the meetings.

165

Although it is true that, in such circumstances, it would have been appropriate for the Commission to postpone the meetings of the Advisory Committee, it cannot, however, be inferred from the low number of representatives of Member States at the meetings that the Commission disregarded the procedural requirement to consult the Advisory Committee in the present case.

166

It should be noted, first of all, that, although it may seem unusual and scarcely compatible with a certain conception of sound administration, no provision is made for any quorum rule for the adoption of opinions of the Advisory Committee. Moreover, Article 14(3) of Regulation No 1/2003 expressly provides that the Advisory Committee may deliver an opinion ‘even if some members are absent and are not represented’. Next, it must be borne in mind that the Commission is required to enable the competition authorities of the Member States to participate in the Advisory Committee and that, in the present case, it took all the necessary steps to that end, since it sent them the invitations to the meetings of the Advisory Committee of 30 June and 7 July 2014 as well as all the necessary documents since the opening of the proceedings (see paragraphs 153 and 154 above) and that no objection was raised as regards the date of those meetings (see paragraph 154 above). Lastly, it should be noted that the Advisory Committee can act as a forum helping to safeguard the consistent application of the EU competition rules, as stated in recital 19 of Regulation No 1/2003, only if the competition authorities of the Member States are willing to cooperate effectively, since the Commission has no enforcement powers in that respect.

167

The plea must therefore be rejected.

3.   Infringement of the right to an effective remedy, the rights of the defence and the principle of equality of arms

(a)   Arguments of the parties

(b)   Findings of the Court

170

It should be pointed out that the principle of effective judicial protection is a general principle of EU law to which expression is now given by Article 47 of the Charter of Fundamental Rights (judgment of 8 December 2011, Chalkor v Commission, C‑386/10 P, EU:C:2011:815, paragraph 52). That principle comprises various elements; in particular, the rights of the defence, the principle of equality of arms, the right of access to a tribunal and the right to be advised, defended and represented (judgment of 6 November 2012, Otis and Others, C‑199/11, EU:C:2012:684, paragraph 48). The principle of equality of arms, which is a corollary of the very concept of a fair hearing, implies that each party must be afforded a reasonable opportunity to present his case, including his evidence, under conditions that do not place him at a substantial disadvantage vis-à-vis his opponent (judgments of 6 November 2012, Otis and Others, C‑199/11, EU:C:2012:684, paragraph 71, and of 12 November 2014, Guardian Industries and Guardian Europe v Commission, C‑580/12 P, EU:C:2014:2363, paragraph 31).

171

The applicants claim that the constraints to which they were subject in lodging the application placed them at a substantial disadvantage vis-à-vis the Commission, which was not subject to any constraints of time or length in drafting the contested decision. It should, however, be recalled that, according to the case-law of the ECtHR on the interpretation of Article 6(1) of the ECHR, to which reference must be made in accordance with Article 52(3) of the Charter of Fundamental Rights, the ‘right to a court’ is not absolute. The exercise of that right is subject to limitations, inter alia as to the conditions for the admissibility of an action (judgment of 28 February 2013, Review Arango Jaramillo and Others v EIB, C‑334/12 RX-II, EU:C:2013:134, paragraph 43). While the persons concerned should expect those rules to be applied, the application of such rules should nevertheless not prevent litigants from availing themselves of an available legal remedy (judgment of 28 February 2013, Review Arango Jaramillo and Others v EIB, C‑334/12 RX-II, EU:C:2013:134, paragraph 43). The ECtHR thus considers that those limitations must not restrict a litigant’s access in such a way or to such an extent that the very essence of the right is impaired, and such limitations will not be compatible with Article 6(1) of the ECHR if they do not pursue a legitimate aim or if there is not a reasonable relationship of proportionality between the means employed and the aim sought to be achieved (see ECtHR, 6 December 2011, Anastasakis v. Greece, CE:ECHR:2011:1206JUD004195908, paragraph 24 and the case-law cited).

172

According to settled case-law of the Court of Justice, the strict interpretation of European Union legislation concerning procedural time limits satisfies the requirement of legal certainty and the need to avoid any discrimination or any arbitrary treatment in the administration of justice (see judgment of 15 January 1987, Misset v Council, 152/85, EU:C:1987:10, paragraph 11 and the case-law cited, and order of 8 November 2007, Belgium v Commission, C‑242/07 P, EU:C:2007:672, paragraph 16 and the case-law cited) and in no way affects the right to effective judicial protection (see, to that effect, order of 17 May 2002, Germany v Parliament and Council, C‑406/01, EU:C:2002:304, paragraph 20). As the Commission argues, the principle of equality of arms does not require that the period allowed for bringing the action for annulment should be the same length as the administrative procedure. The purpose of the administrative procedure is to enable the Commission to carry out an investigation to determine whether a decision finding an infringement of Articles 101 and 102 TFEU must be adopted and to enable the undertakings to prepare their defence. It must be borne in mind, in that regard, that respect for the rights of the defence 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 (judgments of 7 June 1983, Musique Diffusion française and Others v Commission, 100/80 to 103/80, EU:C:1983:158, paragraph 10, and of 7 January 2004, 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, EU:C:2004:6, paragraph 66). To that effect, Regulation No 1/2003 provides that the parties are to be sent a statement of objections which must set forth clearly all the essential facts upon 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. For that reason, the Commission may, and even must, take into account the factors emerging from the administrative procedure in order, inter alia, to abandon such objections as have been shown to be unfounded (judgment of 7 January 2004, 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, EU:C:2004:6, paragraph 67).

173

In the present case, it must be held that, although, in accordance with the provisions of the sixth paragraph of Article 263 TFEU and Article 102(2) of the Rules of Procedure of 2 May 1991, the applicants had a period of 2 months and 10 days from the date of notification of the contested decision in which to bring an action against it, and although that period made the task of drafting the application particularly difficult, in view of the exceptional length of the contested decision, which was moreover notified during the summer period, they nevertheless had the opportunity to have many exchanges with the Commission in relation to the case during the administrative procedure. The Commission, for example, sent requests for information to the applicants in January 2009, August 2009 and then from December 2009 to May 2012. Furthermore, the applicants were invited to attend a number of state of play meetings from 2009 to 2012. On 27 July 2012, the Commission issued a Statement of Objections, to which the applicants submitted a reply on 14 January 2013. The applicants were subsequently heard on 15, 16, 17 and 18 April 2013, further state of play meetings were arranged and additional requests for information sent to the applicants. On 18 December 2013, the Commission granted the applicants access to evidence gathered or more widely disclosed after the Statement of Objections and sent a Letter of Facts to which the applicants replied on 31 January 2014. In addition, it is important to recall that, during the written phase of the proceedings before the Court, the applicants were able to benefit from all the extensions of the time limits which they had requested and therefore were not, broadly speaking, placed at a substantial disadvantage vis-à-vis the Commission in the present proceedings, in spite of the particular constraints to which they were subject in submitting the application.

174

As regards the length of the application, it should be recalled that, according to the case-law of the ECtHR, the rules relating to the formalities to be complied with in bringing an action are intended to ensure the sound administration of justice and that the persons concerned should expect those rules to be applied (ECtHR, 6 December 2011, Anastasakis v. Greece, CE:ECHR:2011:1206JUD004195908, paragraph 24). As regards the procedure before the Court, it is important to note that, pursuant to paragraph 15 of the Practice Directions to Parties before the General Court of 24 January 2012 (OJ 2012 L 68, p. 23), in force on the date the application was lodged, the length of the application is in principle limited to 50 pages, but is always determined on the basis of the complexity in law or in fact of the case in question (see, to that effect, order of 10 April 2014, Langguth Erben v OHIM, C‑412/13 P, not published, EU:C:2014:269, paragraph 63). In the present case, the applicants have relied on the complexity in law of the case in question and have been authorised by the Court to lodge a 186-page application, drafted with reduced line spacing and accompanied by 10158 pages of annexes. Although it is true that the contested decision is particularly lengthy and in certain respects repetitive, this is nonetheless explained, as the Commission argues, by the number of infringements which are alleged against the applicants and which have certain common features, as well as by the standards of proof required by the case-law of the EU Courts concerning infringements of Articles 101 and 102 TFEU. Moreover, as the Commission points out, the applicants had the opportunity to respond to the statement of objections, which is 755 pages in length, and produced a document of more than 600 pages. The length of the application and the number of pleas raised show, furthermore, that the applicants had the time — with no doubt considerable effort, it is true — to prepare their arguments. They cannot, therefore, claim to have been subject to insurmountable difficulties in accessing the Court and to have been placed at a substantial disadvantage vis-à-vis the Commission.

175

As regards the argument relating to the repetitions and references on which the Commission relied in the contested decision, it must be recalled that it is for the Commission, in accordance with Article 296 TFEU, to set out its reasoning in a clear and unequivocal fashion, so as to make the persons concerned aware of the reasons for the measure and to enable the court having jurisdiction to exercise its power of review. Those requirements to be satisfied by the statement of reasons depend on the circumstances of each case, in particular the content of the measure in question, the nature of the reasons given and the interest which the addressees of the measure, or other parties to whom it is of direct and individual concern, may have in obtaining explanations. It is not necessary for the reasoning to go into all the relevant facts and points of law, since the question whether the statement of reasons for a measure meets the requirements of Article 296 TFEU must be assessed with regard not only to its wording but also to its context and to all the legal rules governing the matter in question (see judgment of 27 September 2012, Heijmans Infrastructuur v Commission, T‑359/06, not published, EU:T:2012:489, paragraph 133 and the case-law cited). Contrary to what the applicants maintain, the mere fact that the Commission referred to the same internal documents on numerous occasions in the contested decision and that it made a significant number of references to other parts of the contested decision cannot suffice to establish that the contested decision did not allow them to ascertain the reasons for the measure taken or prevented the Court from exercising its power of review.

176

As regards the argument based on the absence of a clear legal criterion, the applicants have stated that it corresponds with other pleas in their application. It will therefore be examined in the context of the corresponding pleas.

177

Finally, nor is it possible to accept the applicants’ arguments based on the judgments of the ECtHR of 27 October 1993, Dombo Beheer B. V. v. The Netherlands (CE:ECHR:1993:1027JUD001444888), of 15 July 2003, Ernst and Others v. Belgium (CE:ECHR:2003:0715JUD003340096), and of 18 April 2006, Vezon v. France (CE:ECHR:2006:0418JUD006601801). Indeed, the facts and points of law in those cases were very different from those in the present case. Accordingly, the case which gave rise to the judgment of the ECtHR of 27 October 1993, Dombo Beheer B. V. v. The Netherlands (CE:ECHR:1993:1027JUD001444888), in which the ECtHR found a breach of Article 6 of the ECHR, involved a dispute between two private individuals in which one of the two parties had been placed at a substantial disadvantage vis-à-vis the other party, who was the only one able to use witness statements. In the case which gave rise to the judgment of the ECtHR of 15 July 2003, Ernst and Others v. Belgium (CE:ECHR:2003:0715JUD003340096), in which the ECtHR held that there was no breach of Article 6 of the ECHR, the question at issue was whether a State could offer an applicant court access limited to a preliminary issue of admissibility, on the ground that his action was directed against a judge having the right to choose the court having jurisdiction. Finally, the case which gave rise to the judgment of the ECtHR of 18 April 2006, Vezon v. France (CE:ECHR:2006:0418JUD006601801), concerned an infringement of the right to a fair trial, on account of a legislative measure definitively and retroactively determining the merits of ongoing disputes before national courts, which was not, however, justified by an adequate reason relating to the public interest.

178

It follows from the foregoing that the plea, even assuming that it is effective in supporting a criticism of the lawfulness of the contested decision, is, in any event, unfounded.

4.   The distortion of the facts

(a)   Arguments of the parties

(b)   Findings of the Court

184

The Commission challenges the admissibility of this plea on the basis of the provisions of Article 44(1)(c) of the Rules of Procedure of 2 May 1991, applicable in the present case, according to which the application must contain the subject matter of the proceedings and a summary of the pleas in law on which the application is based. That information must be sufficiently clear and precise to enable the defendant to prepare its defence and the Court to rule on the application, if necessary without any further information. In order to guarantee legal certainty and sound administration of justice it is necessary, in order for an action to be admissible under the aforementioned provisions, that the basic legal and factual particulars relied on be indicated, at least in summary form, coherently and intelligibly in the application itself (order of 28 April 1993, De Hoe v Commission, T‑85/92, EU:T:1993:39, paragraph 20). More particularly, the Court of Justice has held that, although it must be accepted that the statement of the grounds for instituting the proceedings need not conform with the phraseology or the list provided for by the second paragraph of Article 263 TFEU, it may be sufficient for the grounds for instituting the proceedings to be expressed in terms of their substance rather than of their legal classification, provided, however, that it is sufficiently clear from the application which of the grounds referred to in the Treaty is being invoked (judgment of 15 December 1961, Fives Lille Cail and Others v High Authority, 19/60, 21/60, 2/61 and 3/61, EU:C:1961:30, p. 294).

185

In the present case, the applicants essentially criticise the Commission for having failed to present certain facts objectively and for having relied on irrelevant facts in order to establish the existence of an infringement. However, although they describe this plea as ‘distortion of the factual context underlying the practices which are the subject of the decision’, the applicants have not specified which rule of law infringed by the Commission is capable of forming the basis for the action, and the information which they provide in their application is not sufficiently clear and precise to enable the Commission to respond to the arguments raised and the EU judicature to exercise its power of review. Indeed, the arguments they put forward could form part of a plea alleging an error of fact, an error regarding the legal characterisation of the facts, an infringement of the principle of impartiality or the duty of diligence, misuse of powers or even damage to reputation capable of justifying an action for compensation.

186

Accordingly, this plea must, for that reason, be declared inadmissible.

187

In the alternative, the Commission argues that this plea is also inadmissible since only the applicants’ conduct which was held to constitute an infringement of Articles 101 and 102 TFEU in the operative part of the contested decision adversely affects them and is capable of being challenged in legal proceedings.

188

According to the case-law, only the operative part of a decision is capable of producing legal effects and of adversely affecting a person’s interests and the assessments made in the recitals are not in themselves capable of forming the subject of an application for annulment. Those assessments can be subject to judicial review by the EU judicature only to the extent that, as grounds of an act adversely affecting a person’s interests, they constitute the essential basis for the operative part of that act (order of 28 January 2004, Netherlands v Commission, C‑164/02, EU:C:2004:54, paragraph 21, and judgment of 17 September 1992, NBV and NVB v Commission, T‑138/89, EU:T:1992:95, paragraph 31) and if, in particular, those grounds are likely to alter the substance of what was decided in the operative part of the measure in question (see judgment of 12 October 2007, Pergan Hilfsstoffe für industrielle Prozesse v Commission, T‑474/04, EU:T:2007:306, paragraph 73 and the case-law cited). It must be borne in mind in that regard that the statement of the reasons for an act is indispensable for determining the exact meaning of what is stated in the operative part (judgments of 15 May 1997, TWD v Commission, C‑355/95 P, EU:C:1997:241, paragraph 21, and of 20 November 2002, Lagardère and Canal+ v Commission, T‑251/00, EU:T:2002:278, paragraph 67).

189

In the present case, it must therefore be determined whether the elements criticised by the applicants contained in Section 4 of the contested decision constitute the essential basis for its operative part and whether those assessments are likely to alter the substance of what was decided in that operative part.

190

It is important to note that the Commission stated, in recitals 85 and 110 of the contested decision, as regards the presentation of the various constituent elements of the applicants’ anti-generic strategy (in particular the creation of a ‘patent cluster’ with ‘paper’ patents and the gradual transition to the arginine salt), that the description of the practices which were not assessed in Section 5 (examination of the settlements under Article 101 TFEU) and Section 8 (examination of the technology acquisition and settlements under Article 102 TFEU) of the contested decision was without prejudice to their legality under competition law. Similarly, in recital 2764 of the contested decision, the Commission specified that none of the elements of the applicants’ general strategy ‘can per se be qualified as problematic under Union competition law’. Moreover, in recitals 2917 and 2960, the Commission recalled that, ‘concerning the abuse of a dominant position, the subject matter of this decision is the overall infringement of Article 102 [TFEU], which consists in the combination of the chain of patent settlements agreements and the acquisition of the Azad technology’. Furthermore, the applicants themselves asked the Court to make confidential vis-à-vis the intervener a number of passages of the contested decision relating to their anti-generic strategy, on the ground that that factual information and its interpretation did not fall within the scope of the complaints made against them by the Commission and that, if that information were disclosed to the public, it would have a serious adverse effect on the applicants by undermining the presumption of innocence and their reputation. The constituent elements of the applicants’ anti-generic strategy which were not classified as an infringement by the Commission therefore were not taken into account for the purposes of establishing and penalising the infringements referred to in the operative part of the contested decision.

191

The applicants claim, however, that, in recital 2766 of the contested decision, which appears in Section 8 of the contested decision, the Commission stated that the assessment of the practices penalised in the case of Article 102 TFEU ‘will take into account the full factual setting, including other practices flowing from the strategy for which the contribution to foreclosure effects is not established in this Decision’. Moreover, in recital 2772 of the contested decision, the Commission stated that the applicants’ anti-generic strategy, described in Section 4 of that decision, and in particular the creation of a patent cluster, constituted ‘important factual elements which help to explain, for example in assessing the anticompetitive foreclosure effects of Servier’s conduct, why the degree of (potential) competition for the supply of generic perindopril was particularly limited’.

192

In its defence, the Commission submits that it was required to set out in the contested decision practices forming part of the applicants’ anti-generic strategy but not classified as infringements of Articles 101 and 102 TFEU, in order to be able to examine the infringements in their legal, economic and factual context. At the hearing, the Commission emphasised the importance of Section 4 of the contested decision in understanding Servier’s overall strategy towards generic companies and the scope of its practices on the market, by distinguishing between the factual context of those practices, clarified in particular by Section 4 of that decision, and whether or not they constituted an infringement. That distinction was clearly made in recital 2766 of the contested decision.

193

It is true that, according to settled case-law, in order to determine whether an agreement between undertakings reveals a sufficient degree of harm that it may be considered a ‘restriction of competition by object’ within the meaning of Article 101(1) TFEU, regard must be had, inter alia, to the economic and legal context of which it forms part (see judgment of 16 July 2015, ING Pensii, C‑172/14, EU:C:2015:484, paragraph 33 and the case-law cited). In order to assess the agreement at issue, it is important to place it in the economic and legal context in the light of which it was concluded by the parties. Such a procedure is not to be regarded as an unwarrantable interference in legal transactions or circumstances which were not the subject of the proceedings before the Commission (judgment of 13 July 1966, Consten and Grundig v Commission, 56/64 and 58/64,EU:C:1966:41, p. 342). When determining that legal and economic context, it is 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 (see judgments of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraph 53 and the case-law cited, and of 19 March 2015, Dole Food and Dole Fresh Fruit Europe v Commission, C‑286/13 P, EU:C:2015:184, paragraph 117 and the case-law cited).

194

Similarly, as part of its examination of the conduct of a dominant undertaking and for the purposes of identifying any abuse of a dominant position, the Commission, is obliged to consider all the relevant facts surrounding that conduct (see, to that effect, judgments of 15 March 2007, British Airways v Commission, C‑95/04 P, EU:C:2007:166, paragraph 67, and of 27 March 2012, Post Danmark, C‑209/10, EU:C:2012:172, paragraph 26). Moreover, it must be observed in that regard that where the Commission undertakes an assessment of the conduct of an undertaking in a dominant position, that assessment being an essential prerequisite of a finding that there is an abuse of such a position, the Commission is necessarily required to assess the business strategy pursued by that undertaking. For that purpose, it is clearly legitimate for the Commission to refer to subjective factors, such as the motives underlying the business strategy in question (judgment of 19 April 2012, Tomra Systems and Others v Commission, C‑549/10 P, EU:C:2012:221, paragraph 19).

195

It is apparent from paragraphs 193 and 194 above that, although the Commission is required to take into consideration the context in which the conduct of an undertaking takes place in order to examine whether it is compatible with Articles 101 and 102 TFEU, that consideration of the context cannot lead to the conclusion or support a finding that there has been an infringement based on different behaviour found to be contrary to or not consistent with competition law, without that behaviour itself being classified as an infringement.

196

In the present case, it is apparent from the contested decision (see paragraph 190 above) that the constituent elements of the applicants’ anti-generic strategy, referred to in Section 4 of the contested decision and presenting Servier’s actions in a negative light, were not classified as an infringement by the Commission and were not taken into account in classifying as an infringement the practices which it penalised with a fine. If the Commission had indeed taken them into consideration in order to classify the practices penalised as an infringement, it would have been open to the criticism that it found infringements based in part on suspicions or assertions resulting not solely from the practices which it decided to penalise but from other conduct. Such an approach could result in an undertaking’s presumed poor reputation, inferred from mere allegations or from facts not clearly established, being analysed as a factor in the examination of the anticompetitive practices alleged against it. However, the impartiality and objectivity which must prevail in the Commission’s classification of infringements and their penalisation, as well as the right to respect for the presumption of innocence, exclude in principle that type of assumption. The Commission’s ambiguity as to the significance of those elements – very critical of Servier’s attitude – set out in Section 4 of the contested decision, which the Commission claims to be both important in its analysis and not open to challenge before the courts, is indicative of possible uncertainties surrounding those grounds of the contested decision.

197

Finally, it should be noted that, even if the various aspects of the applicants’ overall anti-generic strategy form part of the context of the infringements established by the contested decision, those assessments do not, however, appear to have been capable of altering the substance of the operative part of the contested decision. Indeed, it must be borne in mind that consideration of the context in identifying the anticompetitive object cannot remedy a failure actually to identify an anticompetitive object (Opinion of Advocate General Wahl in CB v Commission, C‑67/13 P, EU:C:2014:1958, point 44). Similarly, as regards Article 102 TFEU, although the Commission is obliged to consider all of the relevant facts surrounding the conduct at issue for the purposes of identifying any abuse of a dominant position, the existence of any anticompetitive intent nevertheless constitutes only one of a number of facts which may be taken into account in order to determine that a dominant position has been abused (see, to that effect, judgment of 19 April 2012, Tomra Systems and Others v Commission, C‑549/10 P, EU:C:2012:221, paragraphs 18 to 20).

198

This plea must therefore, and in any event, be rejected as ineffective, since it is directed against the grounds of the contested decision which do not relate to the applicants’ conduct and practices constituting infringements of competition law and penalised by that decision. It should be noted, however, that many of the factual elements criticised by the applicants under this plea (in particular the acquisition of alternative technologies and the patent dispute settlements) relate directly to the practices which the Commission classified as an infringement and are also reproduced under other pleas, as the Commission argues in its defence. Those elements, which may thus be relevant, will be examined in the course of the analysis of those pleas.

5.   Errors of law in defining the concept of a restriction of competition by object

211

By this plea, the applicants and the intervener submit that the Commission erred in law by classifying the patent dispute settlement agreements as restrictions of competition by object and that it disregarded the scope of the intellectual property rights represented by the patents. Consequently, it is for the Court to determine whether such settlement agreements may constitute a restriction of competition by object and, if so, under what conditions, and also to examine whether, in its analysis, the Commission disregarded the scope of the patents.

212

It should be borne in mind, in that regard, that, in the contested decision, the Commission analysed how, in its view, patent dispute settlement agreements should be assessed in the light of the provisions of Article 101(1) TFEU and, in particular, the possibility of classifying such agreements as restrictions by object (recitals 1102 to 1155 of the contested decision).

213

In essence, while acknowledging that companies are generally entitled to settle litigation, including patent litigation (recital 1118 of the contested decision), the Commission considered that patent dispute settlement agreements must comply with EU competition law and, more specifically, with the provisions of Article 101(1) TFEU (see inter alia recitals 1119, 1122 and 1123 of the contested decision).

214

The Commission also took into account the specific context in which competition operates between originator undertakings and generic companies in the pharmaceutical sector. In particular, it referred to the importance of patent challenges in that sector (recitals 1125 to 1132 of the contested decision).

215

In the light of those factors, the Commission considered that, in principle, it might be reasonable for parties to conclude a settlement agreement to resolve a dispute and even to include non-marketing and non-challenge clauses (recitals 1133 and 1136 of the contested decision).

216

However, the Commission took the view that, depending on the specific circumstances of the case, a patent dispute settlement agreement by which a generic company accepts restrictions on its ability and incentives to compete in return for a value transfer, either in the form of significant sums of money or another significant inducement, could be a restriction of competition by object contrary to Article 101 TFEU (recital 1134 of the contested decision). In such a situation, the generic company’s decision not to pursue its independent efforts to enter the market results, not from the parties’ assessment of the merits of the patent, but from a transfer of value from the originator company to the generic company (recital 1137 of the contested decision) and, accordingly, from an exclusionary payment which amounts to the ‘buying off’ of competition (recital 1140 of the contested decision).

217

Consequently, the Commission stated that, in order to determine whether or not the settlement agreements at issue constituted restrictions of competition by object, it would carry out a case-by-case analysis of the facts relating to each of those agreements. To that end, it stated that it would seek in particular to determine (i) whether ‘the generic undertaking and the originator undertaking were at least potential competitors’, (ii) whether ‘the generic undertaking committed itself in the agreement to limit, for the duration of the agreement, its independent efforts to enter one or more EU markets with a generic product’ and (iii) whether ‘the agreement was related to a transfer of value from the originator undertaking as a significant inducement which substantially reduced the incentives of the generic undertaking to independently pursue its efforts to enter one or more EU markets with the generic product’ (recital 1154 of the contested decision).

218

The Commission then applied the three criteria referred to in paragraph 217 above to each of the patent dispute settlement agreements at issue and concluded, in respect of each of those agreements, that those three criteria were met and that, consequently, those agreements should be classified, inter alia, as restrictions of competition by object.

(a)   Whether the patent settlement agreements are restrictions by object

(1) Restrictions of competition by object

219

Article 101(1) TFEU provides that 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 are to be prohibited as incompatible with the internal market. According to settled case-law since the judgment of 30 June 1966, LTM (56/65, EU:C:1966:38, p. 249), the alternative nature of those requirements, indicated by the use of the conjunction ‘or’, leads to the need to consider, in the first place, the precise purpose of the agreement, in the economic context in which it is to be applied. Where, however, an analysis of the terms of the agreement at issue does not reveal a sufficient degree of harm to competition, the effects of the agreement should then 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 (see judgments of 19 March 2015, Dole Food and Dole Fresh Fruit Europe v Commission, C‑286/13 P, EU:C:2015:184, paragraph 116 and the case-law cited, and of 16 July 2015, ING Pensii, C‑172/14, EU:C:2015:484, paragraph 30 and the case-law cited). However, where the anticompetitive object of an agreement is established, it is not necessary to examine its effects on competition (see judgment of 20 January 2016, Toshiba Corporation v Commission, C‑373/14 P, EU:C:2016:26, paragraph 25 and the case-law cited). Thus, in the contested decision, the Commission rightly pointed out, first, that the anticompetitive object and effect of an agreement are not cumulative but alternative conditions for assessing whether an agreement comes within the scope of the prohibition laid down in Article 101(1) TFEU (recital 1109) and, secondly, that it is not necessary to show actual anticompetitive effects of conduct where the anticompetitive object of that conduct is proved (recital 1112).

220

The concept of restriction of competition by object can be applied only to certain types of coordination between undertakings that reveal, by their very nature, a sufficient degree of harm to the proper functioning of normal competition that it may be found that there is no need to examine their effects (see, to that effect, judgments of 30 June 1966, LTM, 56/65, EU:C:1966:38, p. 249; of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraphs 49, 50 and 58 and the case-law cited; of 16 July 2015, ING Pensii, C‑172/14, EU:C:2015:484, paragraph 31; and of 26 November 2015, Maxima Latvija, C‑345/14, EU:C:2015:784, paragraph 20).

221

According to the case-law of the Court of Justice, in order to determine whether an agreement between undertakings reveals a sufficient degree of harm that it may be considered a ‘restriction of competition by object’ within the meaning 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 part (see judgment of 16 July 2015, ING Pensii, C‑172/14, EU:C:2015:484, paragraph 33 and the case-law cited). When determining the economic and legal 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 (see judgment of 19 March 2015, Dole Food and Dole Fresh Fruit Europe v Commission, C‑286/13 P, EU:C:2015:184, paragraph 117 and the case-law cited). Nevertheless, it must be borne in mind that the examination of the real conditions of the functioning and structure of the market in question cannot lead the General Court to assess the effects of the coordination concerned (see, to that effect, judgment of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraphs 72 to 82), since otherwise the distinction established in Article 101(1) TFEU would lose its effectiveness.

222

In addition, although the parties’ intention is not a necessary factor in determining whether a type of coordination 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 (see judgment of 19 March 2015, Dole Food and Dole Fresh Fruit Europe v Commission, C‑286/13 P, EU:C:2015:184, paragraph 118 and the case-law cited). However, the mere fact that an agreement also pursues legitimate objectives is not sufficient to preclude a finding of restriction of competition by object (judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers, C‑209/07, EU:C:2008:643, paragraph 21; see also, to that effect, judgments of 8 November 1983, IAZ International Belgium and Others v Commission, 96/82 to 102/82, 104/82, 105/82, 108/82 and 110/82, EU:C:1983:310, paragraph 25, and of 6 April 2006, General Motors v Commission, C‑551/03 P, EU:C:2006:229, paragraph 64).

223

The applicants maintain that the Commission erred in law by considering that a mere possibility that an agreement might have a negative effect on competition was sufficient in order to classify it as a restriction of competition by object. It is true that, in recital 1111 of the contested decision, the Commission stated, citing the case-law of the Court of Justice (judgments of 4 June 2009, T-Mobile Netherlands and Others, C‑8/08, EU:C:2009:343, paragraph 31, and of 14 March 2013, Allianz Hungária Biztosító and Others, C‑32/11, EU:C:2013:160, paragraphs 35 to 38), that, ‘in order for an agreement to be regarded as having an anticompetitive object, it is sufficient that it has the potential to have a negative impact on competition’ and that ‘in other words, the agreement must simply be capable in an individual case, having regard to the specific legal and economic context, of resulting in the prevention, restriction or distortion of competition within the internal market’.

224

In that regard, it is necessary, first of all, to point out that the Commission, in the contested decision, correctly set out the case-law on the definition of restriction of competition by object, as referred to in paragraphs 219 to 222 above. It can be seen from recitals 1109, 1110, 1112 to 1117 and 1211 of the contested decision that the Commission set out that case-law without erring in law and that it applied that case-law in its analysis of each agreement (see, inter alia, recitals 1369 to 1375, 1475 to 1481, 1622 to 1627, 1763, 1804 to 1810 and 1994 to 2000 of the contested decision). It is irrelevant that the Commission did not use the words ‘sufficient degree of harm’ in the contested decision, since it is apparent from that decision that it correctly grasped the concept of restriction of competition by object. In particular, it indicated in recitals 1110 and 1113 of that decision that those restrictions were ‘those which, “by their very nature”, can be regarded as being injurious to the proper functioning of normal competition’, that, ‘in order to assess if an agreement involves a restriction by object, regard must be had inter alia to the content of its provisions, the objectives it seeks to attain and the economic and legal context of which it forms a part’, and that ‘when determining that context, it is also appropriate 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’. It also rightly noted that, ‘although the parties’ intention is not a necessary factor in determining whether an agreement involves a restriction of competition by object, there is nothing prohibiting the Commission or the Courts of the Union from taking that aspect into account’ (recital 1113 of the contested decision).

225

Next, it must be pointed out that, in paragraph 31 of the judgment of 4 June 2009, T-Mobile Netherlands and Others (C-8/08, EU:C:2009:343), repeated in paragraph 38 of the judgment of 14 March 2013, Allianz Hungária Biztosító and Others (C‑32/11, EU:C:2013:160), the Court of Justice did not intend to assert that an agreement with a low degree of harm which, as a consequence, only might have a negative effect on competition could constitute a restriction of competition by object, but only, first, that the identification of the actual effects of an agreement on competition was not relevant in the analysis of a restriction of competition by object and, secondly, that the mere fact that an agreement was not implemented cannot preclude a finding that it constitutes a restriction of competition by object. A reading of paragraph 31 of the judgment of 4 June 2009, T-Mobile Netherlands and Others (C‑8/08, EU:C:2009:343), in particular in the light of paragraphs 29 and 30 thereof and of point 46 of the Opinion of Advocate General Kokott in that case, to which the judgment refers expressly, and point 47 of that Opinion, allows that paragraph to be placed in the context of the distinction between restrictions of competition by effect and by object.

226

Consequently, the applicants’ arguments that the Commission committed an error of law in recital 1111 of the contested decision must be rejected.

227

The applicants and the intervener further claim, relying on the judgment of 11 September 2014, CB v Commission (C‑67/13 P, EU:C:2014:2204), that the concept of infringement by object should be interpreted restrictively, contrary to the approach taken by the Commission in the contested decision.

228

In that regard, it must be noted that, in the judgment of 11 September 2014, CB v Commission (C‑67/13 P, EU:C:2014:2204, paragraph 58), the Court of Justice stated that the concept of restriction of competition by object could be applied only to certain types of coordination between undertakings which reveal a sufficient degree of harm to competition that it may be found that there is no need to examine their effects and not to agreements which are in no way established to be, by their very nature, harmful to the proper functioning of normal competition. It therefore held that the General Court had erred in law in finding that the concept of restriction of competition by object must not be interpreted restrictively. The Court of Justice did not, however, call into question the case-law according to which the types of agreement referred to in Article 101(1)(a) to (e) TFEU do not constitute an exhaustive list of prohibited collusion (judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers, C‑209/07, EU:C:2008:643, paragraph 23; see also, to that effect, judgment of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraph 58), which is clear from the use of the term ‘in particular’ in Article 101(1) TFEU (Opinion of Advocate General Trstenjak in Beef Industry Development Society and Barry Brothers, C‑209/07, EU:C:2008:467, point 46).

229

It must next be pointed out that, in the present case, the Commission took an approach consistent with the judgment of 11 September 2014, CB v Commission (C‑67/13 P, EU:C:2014:2204), by assessing the agreements at issue in the light of the criteria set out in paragraphs 219 to 222 above (see paragraph 224 above), criteria which are in themselves restrictive, since they require the identification of a sufficient degree of harm. Contrary to the applicants’ and the intervener’s assertions, the Commission’s analysis did not, a priori, have to apply a more restrictive approach than that entailed by the criteria for assessing the concept of restriction of competition by object, but it required the identification of a restriction of competition revealing a sufficient degree of harm or, failing that, an analysis of the actual anticompetitive effects of the agreements at issue.

230

The applicants also submit that the absence of precedent precludes any classification as a restriction by object and argue that the former head of unit responsible for the case publicly recognised that it was unprecedented, as the Commission acknowledged in the contested decision itself. However, it should be noted that the practices referred to in Article 101(1)(a) to (e) TFEU do not constitute an exhaustive list of prohibited collusion (judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers, C‑209/07, EU:C:2008:643, paragraph 23) and that, even though experience may undoubtedly show that certain types of cooperation are inherently harmful to competition (judgment of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraph 51), 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 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 (see judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 438 and the case-law cited).

231

Similarly, contrary to what is maintained by the applicants, the mere fact that a case-by-case approach is necessary in order to identify a restriction of competition by object does not preclude such a classification. The case-law does not require that an agreement be considered to be prima facie or undoubtedly sufficiently harmful to competition, without a concrete and individual examination of its content, its purpose, and its legal and economic context by the Commission or the EU judicature, in order to be regarded as a restriction of competition by object within the meaning of Article 101(1) TFEU (see, to that effect, judgments of 14 March 2013, Allianz Hungária Biztosító and Others, C‑32/11, EU:C:2013:160, paragraph 51, and of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 775).

232

The applicants and the intervener also complain that the contested decision is vitiated by a contradiction in the reasoning, since it is stated in recital 2764 that the patent settlements are not in themselves anticompetitive under Article 102 TFEU. However, it is clear from the sentence in question in recital 2764 of the contested decision that the Commission was referring solely to the practices which were described in the contested decision as forming part of the applicants’ general anti-generic strategy but which were not classified in the contested decision as infringements of competition law. Consequently, that sentence did not refer to the settlements concluded by the applicants. Moreover, it is apparent from the contested decision, and in particular Section 8.3 thereof, that the Commission considered that the settlements concluded by the applicants constituted abusive conduct contributing to the overall single and continuous exclusionary strategy which infringed the provisions of Article 102 TFEU. The contested decision is therefore not vitiated by the alleged contradiction in the reasoning.

233

Having set out the conditions for applying the concept of restriction of competition by object and having examined the applicants’ complaints criticising the interpretation of that concept, it must be noted that, in the present case, the agreements at issue were intended, according to the applicants, to settle disputes between the contracting parties and were concluded in the specific context of patent law, since the disputes in question concerned the applicants’ patents. Since determining whether there is a restriction by object entails an examination of the content of the terms of the agreement in question, its objectives, and its economic and legal context (see paragraph 221 above), it is necessary in the present case to analyse the clauses prohibiting patent challenges and the clauses prohibiting the marketing of products which infringe those patents, contained in settlement agreements in general and in the agreements at issue in particular, in the light of their objective of settling patent disputes and the specific context, namely that of patents, in order to verify whether the Commission, correctly and in accordance with legally appropriate criteria, classified those agreements as restrictive of competition by object.

(2) Intellectual property rights and, in particular, patents

234

The specific purpose of awarding a patent is to ensure that its proprietor, 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, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraph 9). When granted by a public authority, a patent is normally presumed to be valid and an undertaking’s ownership of that right is presumed to be lawful. The mere possession by an undertaking of such an exclusive right normally results in keeping competitors away, since public regulations require them to respect that exclusive right (judgment of 1 July 2010, AstraZeneca v Commission, T‑321/05, EU:T:2010:266, paragraph 362).

235

The exercise of the rights arising under a patent granted in accordance with the legislation of a Member State does not, of itself, constitute an infringement of the rules on competition laid down by the Treaty (judgment of 29 February 1968, Parke, Davis and Co., 24/67, EU:C:1968:11, p. 71). Intellectual property rules are even essential in order to maintain competition undistorted on the internal market (judgment of 16 April 2013, Spain and Italy v Council, C‑274/11 and C‑295/11, EU:C:2013:240, paragraph 22). First, by rewarding the creative effort of the inventor, patent law contributes to promoting an environment conducive to innovation and investment and, secondly, it is intended to make public the modes of operation of inventions and thus allow further breakthroughs to emerge. Paragraph 7 of the 2004 Guidelines on technology transfer agreements, the provisions of which were included in their entirety in point 7 of the 2014 Guidelines on technology transfer agreements, thus acknowledges that:

‘[There is no] inherent conflict between intellectual property rights and the Community competition rules. Indeed, both bodies of law share the same basic objective of promoting consumer welfare and an efficient allocation of resources. Innovation constitutes an essential and dynamic component of an open and competitive market economy. Intellectual property rights promote dynamic competition by encouraging undertakings to invest in developing new or improved products and processes. So does competition by putting pressure on undertakings to innovate. Therefore, both intellectual property rights and competition are necessary to promote innovation and ensure a competitive exploitation thereof.’

236

According to settled case-law, the right to property, which includes intellectual property rights, constitutes a general principle of EU law (judgment of 29 January 2008, Promusicae, C‑275/06, EU:C:2008:54, paragraph 62; see also, to that effect, judgment of 12 July 2005, Alliance for Natural Health and Others, C‑154/04 and C‑155/04, EU:C:2005:449, paragraph 126 and the case-law cited).

237

However, intellectual property rights, and in particular patent rights, are not absolute; rather they must be viewed in relation to their social function and must be reconciled with other fundamental rights, and they may be restricted in order to meet the objectives of general interest pursued by the European Union, provided that those restrictions do not constitute, in relation to the aim pursued, a disproportionate and intolerable interference, impairing the very substance of the right guaranteed (see judgment of 12 July 2005, Alliance for Natural Health and Others, C‑154/04 and C‑155/04, EU:C:2005:449, paragraph 126 and the case-law cited). For example, the Court of Justice has held, in disputes relating to the interpretation of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ 2009 L 152, p. 1), that it is necessary to balance the interests of the patent-holding pharmaceutical industry and those of public health (see, to that effect, judgment of 12 March 2015, Actavis Group PTC and Actavis UK, C‑577/13, EU:C:2015:165, paragraph 36 and the case-law cited).

238

It should also be borne in mind that Article 3(3) TEU states that the European Union is to establish an internal market, which — in accordance with Protocol No 27 on the internal market and competition, annexed to the Treaty of Lisbon (OJ 2010 C 83, p. 309), which, under Article 51 TEU, has the same legal value as the Treaties — includes a system ensuring that competition is not distorted. Articles 101 and 102 TFEU are among the competition rules referred to in Article 3(1)(b) TFEU which are necessary for the functioning of that internal market. The function of those rules is precisely to prevent competition from being distorted to the detriment of the public interest, individual undertakings and consumers, thereby ensuring the well-being of the European Union (judgment of 17 February 2011, TeliaSonera Sverige, C‑52/09, EU:C:2011:83, paragraphs 20 to 22).

239

Although the Treaties have never expressly provided for reconciliation between intellectual property rights and competition law, Article 36 EC, the provisions of which were reproduced in Article 36 TFEU, nevertheless provided for a reconciliation of intellectual property rights with the principle of free movement of goods, by indicating that the provisions of the Treaty relating to the prohibition of quantitative restrictions between Member States were not to preclude restrictions on imports, exports or goods in transit justified, inter alia, on grounds of the protection of industrial and commercial property, while specifying that those restrictions should not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. The Court of Justice considers that Article 36 EC thus intended to draw a distinction between the existence of a right conferred by the legislation of a Member State in regard to the protection of artistic and intellectual property, which cannot be affected by the provisions of the Treaty, and the exercise of such right, which might constitute a disguised restriction on trade between Member States (see, to that effect, judgment of 6 October 1982, Coditel and Others, 262/81, EU:C:1982:334, paragraph 13).

240

The EU legislature has moreover had occasion to point out the need for such reconciliation. Thus, Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ 2004 L 157, p. 45), the objective of which is to approximate national laws so as to ensure a high, equivalent and homogeneous level of protection of intellectual property in the internal market (recital 10) and ‘to ensure full respect for intellectual property, in accordance with Article 17(2) of [the Charter of Fundamental Rights]’ (recital 32), states that it ‘should not affect the application of the rules of competition, and in particular Articles [101] and [102 TFEU]’ and that ‘the measures provided for in this Directive should not be used to restrict unduly competition in a manner contrary to the Treaty’ (recital 12).

241

The Court of Justice has developed case-law in relation to various types of intellectual property rights intended to reconcile the competition rules with the exercise of these rights, without affecting their substance, by using the same reasoning as that which allows it to reconcile those rights and the free movement of goods. Thus, for the Court of Justice, the misuse of intellectual property rights must be penalised, but not the lawful exercise of those rights, which it defines on the basis of their specific subject matter, a concept which is used synonymously in the Court’s case-law with the concepts of the actual substance of those rights and the essential prerogatives of their proprietor. According to the Court of Justice, the exercise of the prerogatives which form part of the specific subject matter of an intellectual property right thus concerns the existence of that right (see, to that effect, Opinion of Advocate General Gulmann in RTE and ITP v Commission, C‑241/91 P, EU:C:1994:210, points 31 and 32 and the case-law cited). Nevertheless, the Court of Justice considers that the exercise of the exclusive right by the proprietor may, in exceptional circumstances, also give rise to conduct contrary to the competition rules (judgment of 6 April 1995, RTE and ITP v Commission, C‑241/91 P and C‑242/91 P, EU:C:1995:98, paragraph 50; see also, to that effect, judgment of 17 September 2007, Microsoft v Commission, T‑201/04, EU:T:2007:289, paragraph 691).

242

As regards patents, the Court of Justice has ruled that it is possible that the provisions of Article 101 TFEU may apply if the use of one or more patents, in concert between undertakings, were to lead to the creation of a situation which may come within the concepts of agreements between undertakings, decisions of associations of undertakings or concerted practices within the meaning of Article 101(1) TFEU (judgment of 29 February 1968, Parke, Davis and Co., 24/67, EU:C:1968:11, p. 71). It further considered, in 1974, that although the existence of rights recognised under the industrial property legislation of a Member State is not affected by Article 101 TFEU, the conditions under which those rights may be exercised may nevertheless fall within the prohibitions contained in that article and that this may be the case whenever the exercise of such a right appears to be the object, the means or the consequences of a restrictive agreement (judgment of 31 October 1974, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraphs 39 and 40).

243

It must borne in mind that, in the absence of harmonisation at the European Union level of the patent law applicable in the present case, the extent of the patent protection conferred by a patent granted by a national patent office or by the EPO can only be determined in the light of non-European Union rules, that is to say, national law or the EPC (see, to that effect, judgments of 16 September 1999, Farmitalia, C‑392/97, EU:C:1999:416, paragraph 26, and of 24 November 2011, Medeva, C‑322/10, EU:C:2011:773, paragraphs 22 and 23). Consequently, where, in the context of an action for annulment brought against a Commission decision, the EU judicature is called upon to examine a settlement agreement in relation to a patent governed by rules other than those of EU law, it is not for it to define the scope of that patent or to rule on its validity. It should also be noted that, in the present case, in the contested decision, although the Commission referred, in recitals 113 to 123, to the applicants’ strategy of creating a ‘patent cluster’ and ‘paper patents’, it did not, however, rule on the validity of the disputed patents at the time the agreements were concluded.

244

While it is not for the Commission or the General Court to rule on the validity of a patent, the existence of the patent must nevertheless be taken into account in the analysis carried out in the framework of the EU competition rules. The Court of Justice has already stated that although the Commission is not competent to determine the scope of a patent, it is still the case that 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 Article 101 or 102 TFEU, since even in cases where the protection afforded by a patent is the subject of proceedings before the national courts, the Commission must be able to exercise its powers in accordance with the provisions of Regulation No 1/2003, the Commission’s findings do not in any way pre-empt the determinations made later by national courts in disputes brought before them on the subject of patent rights and the Commission’s decision is subject to review by the EU judicature (judgment of 25 February 1986, Windsurfing International v Commission, 193/83, EU:C:1986:75, paragraphs 26 and 27).

245

Lastly, it must be noted that intellectual property rights are protected by the Charter of Fundamental Rights. Under Article 17(1) of the Charter of Fundamental Rights, to which the Treaty of Lisbon has conferred the same legal value as the Treaties (Article 6(1) TEU), ‘everyone has the right to own, use, dispose of and bequeath his or her lawfully acquired possessions’, ‘no one may be deprived of his or her possessions, except in the public interest and in the cases and under the conditions provided for by law, subject to fair compensation being paid in good time for their loss’, and ‘the use of property may be regulated by law in so far as is necessary for the general interest’. Article 17(2) of the Charter of Fundamental Rights states, moreover, that ‘intellectual property shall be protected’. Consequently, the guarantees provided for in Article 17(1) of the Charter of Fundamental Rights apply also to intellectual property. The Court of Justice has held that the recognition of intellectual property rights in the Charter of Fundamental Rights entails a need for a high level of protection of those rights and that it is necessary to strike a balance between maintaining free competition — in respect of which primary law and, in particular, Articles 101 and 102 TFEU prohibit anticompetitive agreements, decisions and concerted practices and abuses of a dominant position — and the requirement to safeguard the patent holder’s intellectual property rights, guaranteed by Article 17(2) of the Charter of Fundamental Rights (see, to that effect, judgment of 16 July 2015, Huawei Technologies, C‑170/13, EU:C:2015:477, paragraphs 42 and 58).

(3) Patent dispute settlements

246

As a preliminary point, it must be noted that the discussion below does not concern patents obtained fraudulently, ‘fictitious’ disputes or disagreements which have not reached the judicial stage. The Commission acknowledged in recital 1170 of the contested decision that, at the time the settlement agreements were concluded, the applicants and the generic companies were all parties to, or associated with a dispute before a national court or the EPO concerning the validity of some of the applicants’ patents or the infringing nature of the product developed by the generic company.

247

First of all, it should be noted that it is a priori legitimate for the parties to a dispute relating to a patent to conclude a settlement agreement rather than pursuing litigation before a court. As the Commission rightly stated in recital 1102 of the contested decision, companies are generally entitled to settle litigation, including patent litigation, and those settlements often benefit both parties to the dispute and allow for a more efficient allocation of resources than if litigation were to be pursued to judgment. An applicant is not required to pursue litigation which it voluntarily initiated. It should be added that the settlement of disputes before the courts, in addition to the fact that it generates a cost for society, cannot be regarded as the preferred and ideal route for conflict resolution. An increase in litigation before the courts may reflect failures or shortcomings which could be remedied in other ways or be dealt with by appropriate prevention actions. If the national systems for granting patents or that of the EPO were experiencing such difficulties, for example by being too liberal in granting protection to processes which are devoid of inventive character, those problems could not justify an obligation or even an incentive for undertakings to pursue patent disputes until a judicial outcome is reached.

248

Likewise, paragraphs 204 and 209 of the 2004 Guidelines on technology transfer agreements, which are applicable at the very least to agreements concerning the licensing of technology, acknowledge the possibility of concluding settlement and non-assertion agreements which include the granting of licences and indicate that, in the context of such a settlement and non-assertion agreement, non-challenge clauses are generally considered to fall outside the scope of Article 101(1) TFEU. Point 235 of the 2014 Guidelines on technology transfer agreements, which replaced the 2004 Guidelines, also states that ‘settlement agreements in the context of technology disputes are, as in many other areas of commercial disputes, in principle a legitimate way to find a mutually acceptable compromise to a bona fide legal disagreement’. That paragraph also states that ‘the parties may prefer to discontinue the dispute or litigation because it proves to be too costly, time-consuming and/or uncertain as regards its outcome’, and that ‘settlements can also save courts and/or competent administrative bodies effort in deciding on the matter and can therefore give rise to welfare enhancing benefits’.

249

Moreover, the Commission itself uses an administrative procedure in relation to agreements and concerted practices which is similar in some respects to a settlement agreement. The settlement procedure, which was established by Commission Regulation (EC) No 622/2008 of 30 June 2008 amending Regulation No 773/2004, as regards the conduct of settlement procedures in cartel cases (OJ 2008 L 171, p. 3), is intended to simplify and speed up administrative procedures and to reduce the number of cases brought before the EU judicature, and thus to enable the Commission to handle more cases with the same resources (judgment of 20 May 2015, Timab Industries and CFPR v Commission, T‑456/10, EU:T:2015:296, paragraphs 59 and 60).

250

In addition, according to the case-law, the ability to assert one’s rights through the courts and the judicial control which that entails constitute the expression of a general principle of law which underlies the constitutional traditions common to the Member States and which is laid down in Articles 6 and 13 of the ECHR. As access to the courts is a fundamental right and a general principle ensuring the rule of law, it is only in wholly exceptional circumstances that the fact that legal proceedings are brought is capable of constituting an infringement of competition law (judgment of 17 July 1998, ITT Promedia v Commission, T‑111/96, EU:T:1998:183, paragraph 60). As the Court of Justice noted, the need for a high level of protection for intellectual-property rights means that, in principle, the proprietor may not be deprived of the right to have recourse to legal proceedings to ensure effective enforcement of his exclusive rights (judgment of 16 July 2015, Huawei Technologies, C‑170/13, EU:C:2015:477, paragraph 58). Symmetrically, the fact that a company decides to use extrajudicial means of resolving a dispute rather than pursuing the litigation route is merely an expression of the same freedom to choose the means of defending its rights and cannot, in principle, constitute an infringement of competition law.

251

Although access to the courts is a fundamental right, it cannot however be considered that it is an obligation, even if it would help to increase competition between economic operators. First, it should be noted that, despite the wide range of procedures and systems for the grant of patents in the various EU Member States and before the EPO at the time of the facts of the present case, an intellectual property right granted by a public authority is normally assumed to be valid and an undertaking’s ownership of that right is assumed to be lawful (judgment of 1 July 2010, AstraZeneca v Commission, T‑321/05, EU:T:2010:266, paragraph 362). Secondly, while it is indeed in the public interest to eliminate any obstacle to economic activity which might arise where a patent was granted in error (see, to that effect, judgment of 25 February 1986, Windsurfing International v Commission, 193/83, EU:C:1986:75, paragraphs 92 and 93) and while it is generally acknowledged that public budgets, including those dedicated to covering health expenditure, are under significant constraints and that competition, in particular competition provided by generic medicinal products developed by generic companies, can effectively contribute to keeping those budgets under control, it should also be borne in mind, as the Commission rightly stated in recital 1201 of the contested decision, that any undertaking remains free to decide whether or not to bring an action against the patents covering the originator medicinal products held by the originator companies. In addition, such a decision to bring or not to bring an action or to settle a dispute does not, in principle, prevent other undertakings from challenging those patents.

252

It follows from all the foregoing that, for the purposes of reconciling patent law and competition law in the particular context of settlements between parties to a patent dispute, a balance must be struck between, on the one hand, the need to allow undertakings to make settlements, the increased use of which is beneficial for society and, on the other hand, the need to prevent the risk of misuse of settlement agreements, contrary to competition law, leading to entirely invalid patents being maintained and, especially in the medicinal products sector, an unjustified financial burden for public budgets.

(4) The reconciliation of patent settlement agreements and competition law

253

It should be noted that the use of a settlement to resolve a patent dispute does not exempt the parties from the application of competition law (see, to that effect, judgments of 27 September 1988, Bayer and Maschinenfabrik Hennecke, 65/86, EU:C:1988:448, paragraph 15, and of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 118; see, by analogy, judgment of 30 January 1985, BATCigaretten-Fabriken v Commission, 35/83, EU:C:1985:32, paragraph 33; see, also, paragraph 204 of the 2004 Guidelines on technology transfer agreements and point 237 of the 2014 Guidelines on technology transfer agreements).

254

The Court of Justice has thus held, in particular, that a non-challenge clause in respect of a patent, including when it was inserted into an agreement intended to settle a dispute pending before a court, might, in the light of the legal and economic context, restrict competition within the meaning of Article 101(1) TFEU (judgment of 27 September 1988, Bayer and Maschinenfabrik Hennecke, 65/86, EU:C:1988:448, paragraphs 14 to 16).

255

It is therefore necessary to identify the relevant factors which justify a conclusion that a non-challenge clause in respect of a patent and, more broadly, a patent settlement agreement restricts competition by object, bearing in mind that determining whether there is a restriction by object entails an examination of the content of the terms of the agreement in question, its objectives, and its economic and legal context (see paragraph 221 above).

256

As a preliminary point, it should be noted that a patent dispute settlement agreement may have no negative impact on competition. That is the case, for example, if the parties agree that the patent at issue is not valid and therefore provide for the immediate market entry of the generic company.

257

The agreements at issue in the present case do not fall into that category because they contain non-challenge clauses in respect of patents and non-marketing clauses in respect of products, which are, by themselves, restrictive of competition. The non-challenge clause undermines the public interest in eliminating any obstacle to economic activity which may arise where a patent was granted in error (see, to that effect, judgment of 25 February 1986, Windsurfing International v Commission, 193/83, EU:C:1986:75, paragraph 92) and the non-marketing clause entails the exclusion from the market of one of the patent holder’s competitors.

258

Nevertheless, the insertion of such clauses may be legitimate, but only in so far as it is based on the parties’ recognition of the validity of the patent in question (and, consequently, of the infringing nature of the generic products concerned).

259

First, non-marketing and non-challenge clauses are necessary for the settlement of some disputes related to patents. If the parties to a dispute were unable to make use of such clauses, the settlement of the dispute would be of no interest in cases in which both parties agree on the validity of the patent. It must, moreover, be noted in this connection that the Commission stated, in paragraph 209 of the 2004 Guidelines on technology transfer agreements, that ‘it is inherent in [settlement agreements] that the parties agree not to challenge ex post the intellectual property rights covered by the agreement [since] the very purpose of the agreement is to settle existing disputes and/or to avoid future disputes’. It is equally necessary, in order to achieve that purpose, that the parties agree that no infringing product may be marketed.

260

Secondly, the insertion of non-marketing clauses merely, in part, reinforces the pre-existing legal effects of a patent which the parties explicitly or implicitly recognise as valid. A patent normally enables its holder to prevent its competitors from marketing the product covered by the patent or a product obtained through the process covered by the patent (see paragraph 234 above). However, by agreeing to a non-marketing clause, the generic company undertakes not to sell products likely to infringe the patent in question. If that clause is limited to the scope of the patent at issue, it may be regarded as essentially duplicating the effects of that patent, in so far as it is based on the recognition of the validity of that patent. As regards non-challenge clauses, the patent cannot be interpreted as affording protection against actions brought in order to challenge the validity of a patent (judgment of 25 February 1986, Windsurfing International v Commission, 193/83, EU:C:1986:75, paragraph 92). The effects of those clauses therefore do not overlap with the effects of the patent. However, when a non-challenge clause is adopted as part of the settlement of a genuine dispute in which the competitor has already had the opportunity to challenge the validity of the patent concerned and ultimately acknowledges that validity, such a clause cannot be regarded, in that context, as undermining the public interest in eliminating any obstacle to economic activity which may arise where a patent was granted in error (see paragraph 257 above).

261

The Commission itself stated, in the contested decision, that non-marketing clauses and non-challenge clauses were generally inherent in any settlement. It thus considered that ‘when in a patent dispute or patent litigation, a settlement is reached on the basis of each party’s assessment of the patent case before them, such a patent settlement is unlikely to infringe competition law even though it may contain an obligation on the generic undertaking not to use the invention covered by the patent during the period of patent protection (e.g. a non-compete clause) and/or an obligation not to challenge the patent concerned in court (e.g. a non-challenge clause)’ (recital 1136 of the contested decision).

262

Thus, the mere presence, in settlement agreements, of non-marketing clauses and non-challenge clauses whose scope is limited to that of the patent in question does not — despite the fact that those clauses are, by themselves, restrictive (see paragraph 257 above) — justify a finding of a restriction of competition sufficiently harmful to be described as a restriction by object, where those agreements are based on the recognition, by the parties, of the validity of the patent (and, consequently, the infringing nature of the generic products concerned).

263

The presence of non-marketing and non-challenge clauses whose scope is limited to that of the patent in question is, however, problematic when it is apparent that the generic company’s agreement to those clauses is not based on its recognition of the validity of the patent. As the Commission rightly points out, ‘even if the limitations in the agreement on the generic undertaking’s commercial autonomy do not go beyond the material scope of the patent, they constitute a breach of 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 1137 of the contested decision).

264

In that respect, it should be noted that the existence of a ‘reverse payment’, that is to say a payment from the originator company to the generic company, is doubly suspect in the context of a settlement agreement. In the first place, it must be borne in mind that a patent is intended to reward the creative effort of the inventor by allowing him to make a fair profit from his investment (see paragraph 234 above) and that a valid patent must, in principle, allow a transfer of value to its holder — for example, through a licence agreement — and not vice versa. In the second place, the existence of a reverse payment gives rises to doubts as to whether the settlement is actually based on the recognition, by the parties to the agreement, of the validity of the patent in question.

265

However, the mere presence of a reverse payment does not mean that there is a restriction by object. It is possible that some reverse payments, where they are inherent in the settlement of the dispute in question, may be justified (see paragraphs 277 to 280 below). However, where an unjustified reverse payment occurs in the conclusion of the settlement, the generic company must then be regarded as having been induced by that payment to agree to the non-marketing and non-challenge clauses and it must be concluded that there is a restriction by object. In that case, the restrictions of competition introduced by the non-marketing and non-challenge clauses no longer relate to the patent and to the settlement, but rather can be explained by the conferral of a benefit inducing the generic company to abandon its competitive efforts.

266

It must be pointed out that, although neither the Commission nor the Courts of the European Union are competent to rule on the validity of the patent (see paragraphs 243 and 244 above), it is nevertheless the case that those institutions may, in the context of their respective powers and without ruling on the intrinsic validity of the patent, find that it has been used abnormally, in a manner which has no relation to its specific subject matter (see, to that effect, judgments of 29 February 1968, Parke, Davis and Co., 24/67, EU:C:1968:11, pp. 71 and 72, and of 31 October 1974, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraphs 7 and 8; see also, by analogy, judgments of 6 April 1995, RTE and ITP v Commission, C‑241/91 P and C‑242/91 P, EU:C:1995:98, paragraph 50, and of 4 October 2011, Football Association Premier League and Others, C‑403/08 and C‑429/08, EU:C:2011:631, paragraphs 104 to 106).

267

Inducing a competitor to accept non-marketing and non-challenge clauses, in the sense described in paragraph 265 above, or its corollary, accepting such clauses because of an inducement, constitutes an abnormal use of the patent.

268

As the Commission rightly stated in recital 1137 of the contested decision, ‘patent law does not provide for a right to pay actual or potential competitors to stay out of the market or to refrain from challenging a patent prior to entering the market’. Likewise, according to the Commission, ‘patent holders are not entitled to pay generic companies to keep them off the market and reduce the risks of competition, whether in the context of a patent settlement agreement or otherwise’ (recital 1141 of the contested decision). Lastly, the Commission correctly added that ‘paying or otherwise inducing potential competitors to stay out of the market [was] not part of any patent right, nor [was] it one of the means provided for under patent law to enforce the patent’ (recital 1194 of the contested decision).

269

Where an inducement has been found, the parties may no longer rely on their recognition, in the context of the settlement, of the validity of the patent. The fact that the validity of the patent is confirmed by a judicial or administrative body is, in that regard, irrelevant.

270

It is then the inducement, and not the recognition of the validity of the patent by the parties to the settlement, which must be regarded as the real cause of the restrictions of competition introduced by the non-marketing and non-challenge clauses (see paragraph 257 above), which — since they are in that case entirely illegitimate — therefore reveal a sufficient degree of harm to the proper functioning of normal competition that a restriction by object may be found.

271

Where they involve an inducement, the agreements in question must therefore be regarded as market exclusion agreements, in which the ‘stayers’ are to compensate the ‘goers’. Such agreements actually constitute a buying-off of competition and must therefore be classified as restrictions of competition by object, as follows from the judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers (C‑209/07, EU:C:2008:643, paragraphs 8 and 31 to 34), and the Opinion of Advocate General Trstenjak in Beef Industry Development Society and Barry Brothers, (C‑209/07, EU:C:2008:467, point 75), referred to in inter alia recitals 1139 and 1140 of the contested decision. Moreover, the exclusion of competitors from the market constitutes an extreme form of market sharing and of limitation of production (judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 435) which, in a context such as that of the agreements in question, reveals a degree of harm which is all the greater since the companies excluded are generic companies, the market entry of which is, as a rule, favourable to competition and which also contributes to the public interest in lowering the cost of healthcare. Lastly, that market exclusion is augmented, in the agreements at issue, by the fact that it is not possible for the generic company to challenge the patent at issue.

272

It follows from all the foregoing that, in the context of patent dispute settlement agreements, a finding of a restriction of competition by object presupposes that the settlement agreement contains both an inducement in the form of a benefit for the generic company and a corresponding limitation of the generic company’s efforts to compete with the originator company. Where those two conditions are met, a finding of restriction of competition by object must be made in view of the harmfulness of that agreement to the proper functioning of normal competition.

273

Thus, where a patent settlement agreement contains non-marketing and non-challenge clauses, the inherently restrictive nature of which (see paragraph 257 above) has not been validly called into question, the existence of an inducement for the generic company to agree to those clauses supports the conclusion that there is a restriction by object, even if there is a genuine dispute, the settlement agreement includes non-marketing and non-challenge clauses the scope of which does not exceed that of the patent at issue and that patent could — having regard, in particular, to the decisions adopted by the competent administrative authorities or courts — legitimately be regarded as valid by the parties to the agreement at the time it was adopted.

274

In the contested decision, the Commission rightly examined whether the agreements at issue in the present case involved a value transfer from the originator company to the generic company representing a ‘significant’ inducement, that is to say liable to lead the latter to accept non-marketing and non-challenge clauses, and concluded, having found such an inducement, that there was a restriction of competition by object.

275

It follows from all the foregoing that the Commission did not vitiate the contested decision by an error of law by applying the inducement criterion for the purpose of distinguishing settlement agreements which constitute restrictions by object from those which do not constitute such restrictions, referred to below as the ‘inducement’ or ‘inducive benefit’ criterion.

276

Nor can such an error of law be inferred from any alleged failure to take into account the context of the agreements at issue (see, as regards the concept of context, judgment of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraph 53), since it also follows from the foregoing considerations that the inducement criterion is based on an analysis of the substance of the agreements at issue not only with regard to their stated aim, namely to settle patent disputes, but also their specific context, which is characterised by the presence, in the pharmaceutical sector, of patents constituting exclusive rights which enjoy a presumption of validity and the possession of which normally results in keeping competitors away (see paragraph 234 above). The context in which the agreements at issue were concluded was given particular attention in the present case since the Commission sought to demonstrate, for each of those agreements, that the generic company in question was a potential competitor to Servier, that is to say that it had real concrete possibilities of entering the market (see paragraph 317 et seq. below). For the purposes of supplementing the response provided to the plea alleging an error of law committed by the Commission in finding the existence of a restriction by object and making it possible subsequently to examine whether, for each agreement, the Commission committed an error of assessment, it remains necessary to set out in detail the circumstances in which an inducement may be found to exist.

(5) The inducement

277

In order to establish whether or not a reverse payment, that is to say a transfer of value from the originator company to the generic company, constitutes an inducement to accept non-marketing and non-challenge clauses, it is necessary to examine, taking into account its nature and its justification, whether the transfer of value covers costs inherent in the settlement of the dispute. In the contested decision, the Commission therefore rightly examined whether the value transfer corresponded to the specific costs of the settlement for the generic company (recitals 1333 et seq., 1461 et seq., 1592 et seq. and 1969 et seq. of the contested decision).

278

If a reverse payment provided for in a settlement agreement containing clauses restrictive of competition is aimed at compensating costs borne by the generic company that are inherent in that settlement, that payment cannot in principle be regarded as an inducement. Because they are inherent in the settlement agreement, there is an implication that those costs are, as such, based on the recognition of the validity of the disputed patents which that settlement is intended to affirm by bringing to an end the challenges to that validity and the potential infringement of those patents. It therefore cannot be considered that such a reverse payment creates doubts as to whether that settlement is based on the parties’ recognition of the validity of the patent in question (see paragraphs 264 and 265 above). Nevertheless, a finding of an inducement and of a restriction of competition by object is not ruled out in such a case. It means however that the Commission must prove that the amounts corresponding to those costs inherent in the settlement, even if they are established and precisely quantified by the parties to that settlement, are excessive (see, to that effect, recitals 1338, 1465, 1600 and 1973 of the contested decision). Such a disproportion would demonstrate that the costs concerned are not inherently linked with the settlement and, accordingly, it could not be inferred from the reimbursement of those costs that the settlement agreement is based on the recognition of the validity of the patents at issue.

279

It may be considered, as the applicants and the Commission acknowledged at the hearing, that the costs inherent in the settlement of the dispute include, in particular, litigation expenses incurred by the generic company in the context of the dispute between it and the originator company. These expenses were incurred solely for the purposes of the litigation concerning the validity or the infringement of the patents in question, which the settlement is intended to bring to an end on the basis of an agreement acknowledging the validity of the patents. The compensation of those costs is therefore directly linked to that settlement. Consequently, where the litigation expenses of the generic company are established by the parties to the settlement, the Commission can find them to be inducive only by showing that they are disproportionate. In that respect, amounts corresponding to litigation expenses which have not been proved, on the basis of specific and detailed documents, to be objectively indispensable for the conduct of the litigation — having regard inter alia to the legal and factual complexity of the issues dealt with and the generic company’s financial interest in the dispute — must be regarded as disproportionate.

280

By contrast, some costs incumbent upon the generic company are, a priori, too extraneous to the dispute and to its settlement to be regarded as inherent in the settlement of a patent dispute. Those include, for example, the costs of manufacturing the infringing products, corresponding to the value of the stock of those products, and research and development expenses incurred in developing those products. Such costs and expenses are a priori incurred independently of the occurrence of litigation and its settlement and do not represent losses because of that settlement, as is clear from, in particular, the fact that, despite the marketing of the products in question being prohibited under the settlement agreement, they are often sold on markets not covered by that agreement and the fact that the research in question may be used to develop other products. The same is true of sums which must be paid by the generic company to third parties as a result of contractual commitments which were not undertaken in the context of the dispute (for example supply contracts). Such costs incurred in terminating contracts concluded with third parties or in compensating third parties are usually imposed by the contracts in question or are directly connected with those contracts, which, moreover, were concluded by the generic company concerned independently of any dispute with the originator company or its settlement. It is therefore for the parties to the agreement in question, if they do not wish the payment of those costs to be regarded as an inducement, and indicative of a restriction of competition by object, to demonstrate that those costs are inherent in the dispute or in its settlement, and then to justify the amount. They could also, to the same end, invoke the insignificant amount of the repayment of those costs which are a priori not inherent in the settlement of the dispute, showing that that amount is insufficient to constitute a significant inducement to accept the clauses restricting competition stipulated in the settlement agreement (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 360).

281

It is necessary, in order to conclude the analysis of the Commission’s alleged error of law in finding that there was a restriction of competition by object, to examine three subordinate arguments put forward by the applicants and the intervener, based on the applicability to the agreements at issue of the ancillary restraints doctrine, on the implications of US law for the solution to the dispute and on the ambivalent effects caused by the patent settlement agreements.

(6) Whether the ancillary restraints doctrine is applicable to settlement agreements

282

The applicants and the intervener submit that, because of the legitimate objective of patent settlement agreements, the Commission should have applied the objective necessity test, according to which an agreement may be exempted from the application of Article 101(1) TFEU if it has a legitimate purpose and the restrictions on competition which it imposes are objectively necessary and proportionate.

283

As a preliminary point, it should be noted that the applicants did not invoke the application of the ancillary restraints doctrine during the administrative procedure and that the contested decision does not mention it.

284

According to the case-law, if a given operation or activity is not covered by the prohibition 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 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, MasterCard and Others v Commission, C‑382/12 P, EU:C:2014:2201, paragraph 89 and the case-law cited). Where it is not possible to dissociate such a restriction, classified as an ancillary restraint, 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 in Article 101(1) TFEU (judgment of 11 September 2014, MasterCard and Others v Commission, C‑382/12 P, EU:C:2014:2201, paragraph 90).

285

The Commission argues that the precondition for the application of the objective necessity test is not fulfilled, since a patent dispute settlement cannot, in principle, be regarded as an operation which is in no way anticompetitive because of its neutrality or its positive effect on competition. It is true that it follows from settled case-law that the settlement of a dispute does not exempt the parties from the application of the competition rules, since Article 101(1) TFEU made no distinction between agreements whose object is to put an end to litigation and those concluded with other aims in mind (see paragraph 253 above). However, as the applicants and the intervener correctly argue, the case-law does not rule out the possibility that a settlement may not fall within the scope of the prohibition laid down in Article 101(1) TFEU because of its neutrality or its positive effects as regards competition. The application of the objective necessity test in a particular case presupposes that the main operation or activity is in no way anticompetitive because of its neutrality or its positive effect on competition, but it does not require that the main operation or activity be, by its very nature and irrespective of the circumstances of each case, in no way anticompetitive. It is also apparent from the case-law that the main operation or activity cannot be assessed in abstracto but rather depends on the ancillary clauses and restrictions specific to each case (see, to that effect, judgments of 28 January 1986, Pronuptia de Paris, 161/84, EU:C:1986:41, paragraph 14; of 15 December 1994, DLG, C‑250/92, EU:C:1994:413, paragraph 31; and of 12 December 1995, Oude Luttikhuis and Others, C‑399/93, EU:C:1995:434, paragraphs 12 to 14). In addition, it must be borne in mind that numerous provisions of EU law encourage the settlement of disputes (see paragraphs 247 to 250 above).

286

Moreover, the Commission cannot rely on the judgment of 27 September 1988, Bayer and Maschinenfabrik Hennecke (65/86, EU:C:1988:448), to reject, in principle, any possibility of applying the ancillary restraints doctrine to the settlement of disputes. While it is apparent from that judgment that the Court of Justice refused to follow the reasoning proposed by the Commission consisting in regarding a clause prohibiting challenges to a patent contained in a licensing agreement as compatible with Article 101(1) TFEU where certain conditions are fulfilled and stated that Article 101(1) TFEU made no distinction between agreements whose object is to put an end to litigation and those concluded with other aims in mind, it did not however rule out the possibility that a settlement agreement which contains non-challenge and non-marketing clauses might, depending on the legal and economic context, not be anticompetitive (judgment of 27 September 1988, Bayer and Maschinenfabrik Hennecke (65/86, EU:C:1988:448, paragraph 21). Furthermore, that judgment was delivered not in the context of the settlement of a dispute but in the context of a licence agreement.

287

Although a patent dispute settlement agreement which has a neutral or positive effect as regards competition cannot in principle be excluded from the scope of the ancillary restraints doctrine, it is nonetheless necessary to carry out an assessment of the scope of the ancillary restraint of competition, which entails a double assessment. It is necessary to establish, first, whether the restriction is objectively necessary for the implementation of the main operation or activity and, secondly, whether it is proportionate to it (judgments of 18 September 2001, M6 and Others v Commission, T‑112/99, EU:T:2001:215, paragraph 106, and of 29 June 2012, E.ON Ruhrgas and E.ON v Commission, T‑360/09, EU:T:2012:332, paragraph 64).

288

As regards the first condition, according to the case-law, it is necessary to establish whether that operation or activity would be impossible to carry out in the absence of the restriction in question. Thus, the fact that that operation or activity 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 or activity. Such an outcome would undermine the effectiveness of the prohibition laid down in Article 101(1) TFEU (see, to that effect, judgment of 11 September 2014, MasterCard and Others v Commission, C‑382/12 P, EU:C:2014:2201, paragraph 91).

289

As regards, non-challenge and non-marketing clauses, they are inherent in some settlement agreements, namely those which are based on the recognition of the validity of the patent or patents in question (see paragraph 259 above). Such clauses — provided that they reflect the recognition of the validity of the patents by each of the parties and that their scope is limited to that of the patent in question must therefore be regarded as capable of satisfying the first condition of the exception provided by the ancillary restraints doctrine.

290

As regards the second condition, it must be borne in mind that, where a restriction is objectively necessary to implement a main operation or activity, it is still necessary to verify whether its duration and its material, temporal and geographic scope do not exceed what is necessary to implement that operation or that activity. If the scope of the restriction exceeds what is necessary in order to implement the main operation or activity, it must be assessed separately under Article 101(3) TFEU (judgment of 18 September 2001, M6 and Others v Commission, T‑112/99, EU:T:2001:215, paragraph 113). Consequently, a settlement agreement containing non-challenge and non-marketing clauses which do not exceed the duration and scope of the patent the validity of which is recognised therein could benefit from the application of the ancillary restraints doctrine.

291

However, in the present case, the Commission was entitled to refrain from examining whether it was necessary to apply the ancillary restraints doctrine, since it considered that the non-challenge and non-marketing clauses were not based on the recognition of the validity of the patent, but on a transfer of value from the originator company to the generics company constituting an inducement, for the latter, not to exert competitive pressure on the company holding the patent. In such a case, the settlement agreement constitutes a restriction of competition by object which cannot be regarded as an operation which is in no way anticompetitive because of its neutrality or its positive effect on competition. Moreover, non-challenge and non-marketing clauses may be a necessary ancillary only to a settlement agreement based on recognition of the validity of the patent in question by the parties to that agreement (see paragraph 289 above). However, where it involves an inducement, a settlement is not based on such recognition. The non-challenge and non-marketing clauses cannot therefore be regarded as necessary for such a settlement.

(7) The reconciliation of patent settlement agreements and US competition law

292

The applicants rely on the Actavis judgment, maintaining that the Supreme Court of the United States has rejected the approach adopted by the Commission in the present case. The Commission, which referred to that judgment in the contested decision (recital 1199), nevertheless argues that it adopted the same approach as the Supreme Court of the United States, by taking the view that there was no presumption that settlement agreements entailing a transfer of value from the originator company to the generic company were unlawful.

293

The Actavis judgment concerns settlement agreements concluded in the pharmaceutical sector, in which generic companies undertook not to enter the market until a date prior to the expiry date of the patent of the originator company (65 months before the expiry date of the patent for Actavis) and to promote the medicinal product in question to doctors, in return for significant payments (for Actavis, annual payments of USD 19 to 30 million for nine years).

294

It should be noted that, according to settled case-law, national practices, even on the supposition that they are common to all the Member States, cannot prevail in the application of the competition rules set out in the Treaty (see, to that effect, judgment of 17 January 1984, VBVB and VBBB v Commission,43/82 and 63/82, EU:C:1984:9, paragraph 40) and that is the case, a fortiori, as regards the national practices of third countries (see, to that effect, judgment of 28 February 2002, Compagnie générale maritime and Others v Commission, T‑86/95, EU:T:2002:50, paragraph 341 and the case-law cited). The approach adopted by EU competition law as regards the distinction between restrictions on competition by object and by effect differs from United States antitrust law, which draws a distinction between restrictions of competition per se, namely cases in which the anticompetitive effects are so obvious that they require only a ‘quick look’ approach, without taking the context into account, and which are necessarily and irremediably prohibited, and infringements which must be proved according to the rule of reason, that is to say following an examination balancing the pro- and anticompetitive effects of the agreement. First, EU law does not regard any restriction of competition as necessarily and irremediably unlawful, since a restriction of competition by object may, in principle, fall within the exceptions laid down in Article 101(3) TFEU. Secondly, as noted in the case-law, the existence of a rule of reason in EU competition law cannot be upheld (judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission, T‑360/09, EU:T:2012:332, paragraph 65; see also, to that effect, judgment of 23 October 2003, Van den Bergh Foods v Commission, T‑65/98, EU:T:2003:281, paragraph 106). Moreover, the differences between the prevailing regulatory context in the United States and in the European Union, as regards pharmaceutical patents in particular, make it even more difficult to apply the approach adopted in the Actavis judgment, by analogy, to the present case (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 513).

295

Accordingly, the applicants’ argument alleging the failure to have regard to the position of the Supreme Court of the United States must be rejected as ineffective.

(8) The ambivalent effects of the settlement agreements

296

The applicants take the view that the effects of the settlement agreements are ambivalent in nature and cannot, therefore, be classified as a restriction of competition by object.

297

They argue, in the first place, that such agreements have ambivalent potential effects on patent challenges, where there are parallel disputes and where, in proceedings before the EPO, the withdrawal by a party of its opposition does not preclude continuation of the proceedings, since its arguments may be raised by the EPO’s Opposition Division, or Board of Appeal, of its own motion. Moreover, the contested decision failed to take into account the fact that settlement agreements have only ambivalent effects on future disputes, since generic undertakings remain free as to whether or not to bring costly legal proceedings, which may in any event prove to be pointless in certain Member States where proceedings before the EPO are pending.

298

In the second place, the applicants take the view that the potential effects of those agreements on the entry of generics onto the market are also ambivalent, depending on the terms of the agreements and the context in which they apply. Accordingly, it is necessary to take into account the existence of the dispute and the parties’ likelihood of success, the existence of other disputes and the possibility of developing other alternative forms of the product. Moreover, those agreements could allow a faster entry of generics onto the market. Finally, the Commission should take into account the ability and intention of generic undertakings to enter the market at risk.

299

In the third place, the applicants take the view that the Commission cannot penalise patent dispute settlement agreements without assessing their actual effects on the market, in common with the position adopted by the Supreme Court of the United States in the Actavis judgment.

300

The Commission contends that that argument is ineffective, since, in order to determine whether an agreement constitutes a restriction of competition by object, its effects need not be taken into account and a restriction of competition by object may even, in some cases, owing to subsequent circumstances, have no effect. When analysing a restriction by object, it is therefore not necessary to establish which counterfactual situations might arise in the absence of the agreements.

301

In the alternative, the Commission submits, with regard to the effects of the settlement agreements on the patent challenges, that, in the present case, the applicants endeavoured to conclude agreements with all their potential competitors and that only two of the five agreements concluded by them included a clause allowing the entry of the generic undertakings into the market if the patent at issue was annulled.

302

The Commission further submits that it examined, in the contested decision, the ability and intention of each generic undertaking to enter the market at risk.

303

Finally, the Commission argues that the contested decision is not inconsistent with the approach adopted by the Supreme Court of the United States in the Actavis judgment, in the light of the differences between the European concept of restriction by object and the American concept of restriction per se. It also recalls that the case-law of the EU Courts rejects the existence of a rule of reason, since the pro-competitive benefits of an agreement must be examined in the context of Article 101(3) TFEU.

304

As the applicants submit, it must be held that the Commission and the Courts of the European Union cannot, when examining whether an agreement restricts competition by object and, in particular, in assessing the economic and legal context of that agreement, completely ignore its potential effects (Opinion of Advocate General Wahl in ING Pensii, C‑172/14, EU:C:2015:272, point 84). It should be borne in mind that agreements which are restrictive of competition by object are those which reveal a sufficient degree of harm, in that they are so likely to have anticompetitive effects, that it may be found that there is no need to examine their specific effects on the market (see, to that effect, judgment of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraphs 49 and 51 and the case-law cited). It follows that agreements which, having regard to their context, have ambivalent potential effects on the market cannot be regarded as being a restriction of competition by object (Opinion of Advocate General Wahl in CB v Commission, C‑67/13 P, EU:C:2014:1958, point 56).

305

However, in the present case, in so far as the applicants are primarily putting forward, in support of their claims concerning the ambivalent potential effects of the agreements at issue, arguments based on each of those agreements and their context, it is appropriate to respond to the claims in question in the context of the response to the criticisms levelled against the classification of each agreement as a restriction by object, especially since, as the Commission rightly points out, the assessment of the existence of a restriction by object must be made for each agreement as a whole, without separately analysing the restrictive nature of the non-challenge clauses and the non-marketing clauses.

306

In the response to the pleas criticising the assessment of each of the agreements at issue, the question whether the Commission validly found that there was a restriction by object in spite of the claimed potentially pro-competitive effects resulting, in particular, from the context in which those agreements were concluded will therefore be examined and it should be noted in this connection that only those forming the subject matter of the analysis of the restrictions of competition by object will be taken into account (see paragraphs 525, 644 and 989 below).

307

Moreover, as is clear from paragraphs 293 to 295 above, the applicants cannot rely effectively on the Actavis judgment.

(b)   The Commission’s criteria for classifying the settlement agreements as restrictions by object

308

It is in the light of the foregoing considerations that it is necessary to examine the applicants’ arguments relating specifically to each of the three main criteria used by the Commission to classify the settlement agreements at issue as restrictions of competition by object, that is to say, first, the status of the generic undertakings as potential competitors, secondly, the commitment of those undertakings to limit their efforts to enter the market with a generic product and, thirdly, a transfer of value from the originator company to the generic company representing a significant inducement for the latter to limit its efforts at entry (recital 1154 of the contested decision).

(1) The criterion of potential competition

(i) Arguments of the parties

(ii) Findings of the Court

316

The applicants complain, in essence, that the Commission erred in law in using incorrect criteria in order to classify as potential competitors the generic undertakings which concluded the agreements at issue with the applicants. The applicants also criticise the Commission’s assessment of the obstacles to the existence of that potential competition resulting from their patents.

– The criteria for assessing potential competition

The definition of the concept of potential competitor

317

The applicants criticise the Commission for having confined itself, for the purposes of ascertaining whether there was potential competition between the parties to the agreements at issue, to verifying the absence of insurmountable barriers to the entry of generic companies to the market and for not having examined whether those companies had real concrete possibilities of entering that market (see paragraph 309 above).

318

It is indeed apparent from the case-law cited by the applicants that an undertaking is a potential competitor if there are real concrete possibilities for it to enter the market in question and compete with established undertakings. Such a demonstration must not be based on a mere hypothesis, but must be supported by 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 (judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission, T‑360/09, EU:T:2012:332, paragraph 86; see also, to that effect, judgment of 14 April 2011, Visa Europe and Visa International Service v Commission, T‑461/07, EU:T:2011:181, paragraphs 166 and 167 and the case-law cited). 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 (judgments of 14 April 2011, Visa Europe and Visa International Service v Commission, T‑461/07, EU:T:2011:181, paragraph 168, and of 29 June 2012, E.ON Ruhrgas and E.ON v Commission, T‑360/09, EU:T:2012:332, paragraph 87).

319

In other contexts, it has also been held that an undertaking constitutes a potential competitor if there exist no insurmountable barriers to its entry to the market (see, to that effect, judgments of 21 May 2014, Toshiba v Commission, T‑519/09, not published, EU:T:2014:263, paragraph 230, confirmed by the judgment of 20 January 2016, Toshiba Corporation v Commission, C‑373/14 P, EU:C:2016:26, paragraphs 28, 29, 32 and 34, and of 28 June 2016, Portugal Telecom v Commission, T‑208/13, EU:T:2016:368, paragraph 181).

320

It thus follows from the case-law that, depending on the context and the unlawful conduct in question, the threshold for a finding of potential competition may vary. The examination solely of insurmountable barriers to market entry implies that any possibility — even hypothetical — of market entry is sufficient to establish the existence of potential competition, whereas the analysis of real concrete possibilities for market entry means that potential competition could be found to exist only if there are realistic possibilities of entry, which could have taken place in the absence of any restrictive measure

321

Nevertheless, the fact remains that verifying whether certain barriers to entry to the market, in the present case mainly consisting of patents and the obligation to obtain a marketing authorisation, are insurmountable neither calls into question nor is inconsistent with the examination of the real concrete possibilities for entry of generic undertakings based on the examination of their ability and their intention to enter. As the Commission rightly emphasised in the contested decision (footnote 1666) and at the hearing, that verification of the absence of insurmountable barriers ‘served to verify if, in spite of generic company’s general ability and proven intention to enter, there were objective reasons rendering generic entry impossible’ and, thus, to supplement the analysis based on the real concrete possibilities criterion. Indeed, in the presence of insurmountable barriers to entry on a market, it cannot be considered that an operator has real concrete possibilities of entering that market. Therefore, if a market is characterised by barriers to entry, an objective examination of whether those barriers are insurmountable is a useful adjunct to the examination of whether there are real concrete possibilities, based on the individual criteria of the ability and intention of the undertaking in question to enter the market.

322

Reference to the criterion of insurmountable barriers on several occasions in the contested decision (see, in particular, recitals 1125 and 1181) cannot, therefore, lead to the conclusion, as drawn by the applicants, that the Commission adopted a definition of potential competition based solely on that criterion.

323

This is particularly true, since the Commission cited, together with the judgment of 21 May 2014, Toshiba v Commission (T‑519/09, not published, EU:T:2014:263), which applied the criterion of insurmountable barriers (see paragraph 319 above), the judgments of 15 September 1998, European Night Services and Others v Commission (T‑374/94, T‑375/94, T‑384/94 and T‑388/94, EU:T:1998:198), and of 14 April 2011, Visa Europe and Visa International Service v Commission (T‑461/07, EU:T:2011:181), which used the real concrete possibilities criterion, referring to them, moreover, in the introduction to its presentation of the rules on the determination of potential competitors (recitals 1156 and 1157 of the contested decision), as well as several other judgments recalling and applying that definition of potential competition, including the judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission (T‑360/09, EU:T:2012:332) (see paragraph 318 above). The Commission also clearly indicated that the ability to enter a market, which is a characteristic of the real concrete possibilities criterion (see paragraph 318 above), remained ‘the crucial aspect in demonstrating potential competition’ (recital 1163 of the contested decision). Lastly, and above all, in its assessment of each of the generic companies in question as a potential competitor, the Commission concluded — on the basis of several pieces of information specific to each of them, concerning inter alia their production capacities and their stocks of products, their commercial contracts, the steps they had taken to obtain marketing authorisations and their litigation against Servier — that all of them had real concrete possibilities of entering the market (see paragraphs 432 to 438, 579 to 585 and 718 to 722 below). Such a detailed analysis on the basis of information specific to each alleged potential competitor is characteristic of the examination of its real concrete possibilities of entering the market and is not the same as merely checking whether there are insurmountable barriers to entry on a given market, which could result in a finding of potential competition simply because any operator entered the market in question.

324

Those findings are not called into question by the applicants’ claims that the Commission relied essentially on the intention of the generic undertakings to enter the market and on a set of unrealistic assumptions (see paragraph 309 above), since it is clear from the wording of the reply that the applicants are contesting, by those claims, not the criterion used, but the application in the present case of the real concrete possibilities criterion, which is examined below in the context of the response to the complaints directed against the assessment of each of the agreements at issue.

325

It follows that, contrary to what the applicants claim, the Commission assessed potential competition on the relevant market on the basis of the real concrete possibilities criterion.

326

Moreover, it may be noted that, contrary to what the Commission claimed in the rejoinder, referring to the judgment of 20 January 2016, Toshiba Corporation v Commission (C‑373/14 P, EU:C:2016:26) (see paragraph 312 above), it could not limit itself in the present case to verifying the absence of insurmountable barriers to market entry in order to infer the existence of potential competition on that market (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraphs 99 to 101).

327

It is indeed apparent from paragraphs 28, 29, 32 and 34 of the judgment of 20 January 2016, Toshiba Corporation v Commission (C‑373/14 P, EU:C:2016:26), that, in respect of market-sharing agreements, the analysis of the economic and legal context of which the practice forms part may be limited to what is strictly necessary in order to establish the existence of a restriction of competition by object and, in particular, to verifying that the barriers to entry on the market at issue cannot be described as insurmountable (see also, to that effect, judgment of 28 June 2016, Portugal Telecom v Commission, T‑208/13, EU:T:2016:368, paragraphs 177 and 181).

328

However, it must be borne in mind, first of all, that it is clear from the judgment of 20 January 2016, Toshiba Corporation v Commission (C‑373/14 P, EU:C:2016:26), read in the light of the Opinion of Advocate General Wathelet in Toshiba Corporation v Commission (C‑373/14 P, EU:C:2015:427, points 69, 70, 89 and 90), that the limitation established by that judgment of the analysis of the economic and legal context results from the particularly obvious nature of some restrictions by object which, in particular because the agreements in question are neither atypical nor complex, do not require an in-depth analysis of the economic and legal context to establish that they are by nature sufficiently harmful.

329

In the present case, because the agreements at issue were concluded in the form of patent settlements, the unlawful nature of those agreements and the fact that they constituted restrictions on competition by object might not have been evident to an outside observer. It is, in that regard, revealing that the Commission analysed both their anticompetitive objective and their anticompetitive effect. It is also confirmed by the Commission’s classification of the agreements at issue as restrictions by object within the meaning of the judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers (C‑209/07, EU:C:2008:643), without it being necessary to rule at this stage on that classification. Indeed, although it is clear from paragraph 34 of that judgment that market exclusion agreements conflict ‘patently’ with the conception inherent in the Treaty provisions relating to competition, the Court of Justice did not hold that the agreements at issue in that case were, for an outside observer, patently or evidently, exclusion agreements and thus restrictions by object which do not require a detailed analysis of their economic and legal context. On the contrary, it carried out such an analysis of that context and of the clauses and objectives of the agreements at issue in order to conclude therefrom that they were exclusion agreements and, consequently, ‘patently’ agreements restrictive of competition by object (judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers, C‑209/07, EU:C:2008:643, paragraphs 31 to 40).

330

It should be noted, next, that in the case which gave rise to the judgment of 20 January 2016, Toshiba Corporation v Commission (C‑373/14 P, EU:C:2016:26), the production and marketing ability of the producers which participated in the practices at issue were not disputed and the relevant market was not subject to any monopoly. In the present case, however, the ability of the generic companies to produce and market the product at issue is precisely what is disputed, particularly in the light of the exclusive rights represented by the applicants’ patents (see paragraph 234 above and paragraph 357 below). It cannot therefore be inferred from that judgment that the finding that an agreement is a restriction of competition by object does not require, in general, and in particular in circumstances such as those in the present case, verification that the parties to the agreement have real concrete possibilities of entering the relevant market.

331

It follows from all the foregoing that the complaint based on the application of an incorrect definition of potential competition must be rejected.

The criterion of sufficiently fast entry

332

In the contested decision, the Commission, based on the judgments of 3 April 2003, BaByliss v Commission (T‑114/02, EU:T:2003:100), and of 14 April 2011, Visa Europe and Visa International Service v Commission (T‑461/07, EU:T:2011:181), considered that the essential factor for an undertaking to be classified as a potential competitor was that it could enter the market sufficiently quickly to form a constraint on market participants. The Commission pointed out that, although delays might reflect the difficulty of entry in terms of costs and time and that market entry might be less commercially attractive because of those delays, they did not in themselves call into question the ability to enter the market or the constraint on Servier or the other generic undertakings. In the present case, the Commission concluded, referring to the temporal indications given in the exemption regulations and in its guidelines — in particular the Guidelines on the applicability of Article 101 [TFEU] to horizontal cooperation agreements (OJ 2011 C 11, p. 1, ‘the 2011 Guidelines on horizontal cooperation agreements’), which provide for a period not exceeding three years — as well as the indicative and actual lengths of legal proceedings, of the granting of marketing authorisations and of the development of APIs, that the delays alleged by the applicants and the generic companies did not appear to be sufficiently long for the generic challenger not to exert competitive pressure (recitals 1158, 1159, 1182 and footnote 1669 of the contested decision, see also recitals 1125, 1126 and 1296 of that decision).

333

Contrary to the applicants’ assertions, that analysis, from a temporal perspective, of potential competition carried out by the Commission is consistent with the applicable principles.

334

According to settled case-law, an operator cannot be described as a potential competitor unless its potential entry could take place sufficiently quickly to form a constraint on market participants and thus exert competitive pressure on them (judgment of 14 April 2011, Visa Europe and Visa International Service v Commission, T‑461/07, EU:T:2011:181, paragraph 189; see also, to that effect, judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission, T‑360/09, EU:T:2012:332, paragraph 114).

335

That case-law took into account the Guidelines on the applicability of Article [101 TFEU] to horizontal cooperation agreements (OJ 2001 C 3, p. 2; ‘the 2001 Guidelines on horizontal cooperation agreements’) (see also the 2011 Guidelines on horizontal cooperation agreements), which not only affirm the need for a sufficiently fast entry, but also set out indicative periods — of no more than one or three years, depending on the circumstances — that may constitute a sufficiently fast entry, on the basis on other guidelines as well as the Block Exemption Regulations.

336

However, as stated in both those guidelines (footnote 9 of the 2001 Guidelines on horizontal cooperation agreements and footnote 3 of the 2011 Guidelines on horizontal cooperation agreements) and the case-law (see, to that effect, judgment of 14 April 2011, Visa Europe and Visa International Service v Commission, T‑461/07, EU:T:2011:181, paragraphs 171 and 189), these periods are indicative only and the concept of ‘sufficiently fast’ entry depends on the facts of the case at hand and its legal and economic context, which must be taken into account in order to determine whether the undertaking outside the market exerts competitive pressure on the undertakings currently operating in that market (see, to that effect, judgment of 14 April 2011, Visa Europe and Visa International Service v Commission, T‑461/07, EU:T:2011:181, paragraph 169).

337

In the present case, the Commission took into account the specific features of the economic and legal context of the present case by assessing the duration of each of the steps required in order to enter the market. It should be pointed out that, precisely because of the particular features of the pharmaceutical sector and in particular the various steps that must be taken and the existence of patents, generic companies often begin their efforts to enter the market well before the expiry of the patents, in order to have completed the necessary steps by the time those patents expire at the latest. These efforts are therefore likely to exert competitive pressure on the originator undertaking, before, or even well before, the expiry of the patents and the actual market entry of the generic companies (see paragraph 356 below; see also, to that effect, judgments of 6 December 2012, AstraZeneca v Commission, C‑457/10 P, EU:C:2012:770, paragraph 108; of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 163; and of 8 September 2016, Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission, T‑460/13, not published, under appeal, EU:T:2016:453, paragraphs 77 to 79).

338

As the applicants rightly maintain (see paragraph 311 above), it cannot be inferred from this that a generic undertaking may be regarded as one of their potential competitors as soon as and solely because it starts to develop a generic form of perindopril. It is true that the Commission stated, in recital 1125 of the contested decision, that potential competition from generic companies starts when the companies that want to launch a generic medicine begin developing commercially viable technologies for production of the API and the finished product. However, it is apparent from the following statements in that recital, which refer to the subsequent analysis of each of the generic undertakings in question as a potential competitor, and above all from that analysis and the general considerations of the contested decision relating to the criterion of sufficiently fast entry (see paragraph 332 above), that the Commission did not intend to find that the exertion of competitive pressure began on the date that development of the generic product commenced, but wished to highlight the possibility of the exertion of competitive pressure from that commencement date, in the event that the conditions for the exertion of such pressure were met. In any event, even if recital 1125 is interpreted as fixing the start of potential competition on the date that development of the generic product commenced, the criticism of that assessment should be rejected as ineffective, since the Commission has not relied on that recital to conclude that the generic undertakings in question were potential competitors. As the Commission rightly points out, on the date of assessing whether the generic companies were potential competitors, that is at the time of concluding the agreements at issue, it had considered that all those companies had reached an advanced stage of development of their perindopril and had not given a view on their prior status as potential competitors, when they commenced that development (see paragraph 315 above).

339

Similarly, the Commission indeed noted, in footnote 1840 in recital 1296 of the contested decision, the three-year period mentioned in the 2011 Guidelines on horizontal cooperation agreements, but it did not draw any decisive inference from that in the present case, with the result that the complaints criticising it for taking that period into account, in view inter alia of the time required to develop perindopril (recital 3137 of the contested decision), must be rejected as ineffective.

340

Secondly, the Commission relied on the idea of competitive pressure inherent in potential competition in considering that any delays in the process of entering the market experienced by the generic companies were not sufficient by themselves to prevent those companies being regarded as potential competitors when they continued to exert such pressure due to their ability to enter the market and cited, to that effect, the judgment of 3 April 2003, BaByliss v Commission (T‑114/02, EU:T:2003:100). Contrary to the applicants’ assertions, the Commission relied, correctly, on that judgment, since, even though, in that judgment, the Court was ruling on a very different context from that of the present case, it nevertheless took a position on the impact of several deferrals of BaByliss’ market entry on its status as a potential competitor, an impact which is precisely examined in the contested decision. The Court held, in that respect — which, moreover, is not disputed by the applicants — that the deferrals of market entry did not call into question BaByliss’ status as a potential competitor, relying on several factors showing that competitive pressure was exerted as a result of its ability to enter the market in question (judgment of 3 April 2003, BaByliss v Commission, T‑114/02, EU:T:2003:100, paragraphs 102 to 106). It therefore also follows that, in so far as the interest on the part of generic companies to be the first to enter the market may, at the most, have an impact on their intention to enter that market, in view of the size of the expected profits, but not, as such, on their ability to enter it, the Commission was correct, in recital 1182 of the contested decision and contrary to the applicants’ submissions, to dismiss the relevance of that interest on the part of generic companies for the purposes of assessing the alleged delays. In fact, the ability to enter the market must be examined in the light of the economically viable strategy criterion (see paragraph 318 above), that is to say it corresponds to a merely profitable entry, and not to the most profitable of possible market entries, in which the generic company in question would be the first to enter the market and thus the only company to compete with the originator company during a certain period (see, to that effect, judgment of 8 September 2016, Xellia Pharmaceuticals and Alpharma v Commission, T‑471/13, not published, under appeal, EU:T:2016:460, paragraph 124).

341

It follows that all the complaints directed against the Commission’s temporal assessment of the potential competition must be rejected.

The criterion of the incumbent operators’ perception

342

In the contested decision, la Commission found, relying on the judgments of 12 July 2011, Hitachi and Others v Commission (T‑112/07, EU:T:2011:342), and of 21 May 2014, Toshiba v Commission (T‑519/09, not published, EU:T:2014:263), that the perception of the market incumbent should play a role in the assessment of potential competition. According to the Commission, if a market incumbent, who is an experienced operator, perceives a competitive threat from generic companies, such a threat is likely to form a competitive constraint on its behaviour on the market, which is relevant for assessing potential competition. The Commission stated, referring to the judgment of 14 April 2011, Visa Europe and Visa International Service v Commission (T‑461/07, EU:T:2011:181), that potential competition could be no more than the existence of an undertaking outside the market, and its mere existence could give rise to competitive pressure, which is represented by the likelihood of entry (recitals 1160 to 1162). The Commission concluded that, in order to answer the question whether generic companies exert competitive pressure on Servier, the perception of the incumbent operator, Servier, and the perception of other generic competitors would also be taken into account (recital 1163). In the present case, the Commission considered that the generic companies were perceived as potential competitors by both Servier and their own generic rivals (recital 1183).

343

It may be noted from the outset that the Commission, in the contested decision, used the criterion of the incumbent operator’s perception as one of a number of criteria for determining the status of the generic undertakings as potential competitors, as is demonstrated both by the adverb ‘also’ recalled in paragraph 342 above and by the examination of the other criteria for assessing potential competition for each of those companies (see paragraphs 432 to 438, 579 to 585 and 718 to 722 below).

344

Contrary to what the applicants claim, the use of the criterion of the incumbent’s perception as one of a number of criteria for assessing potential competition is consistent with the case-law applicable in the present case, as relied on by the applicants.

345

Indeed, contrary to the applicants’ assertions, the General Court clearly took account of the criterion of the incumbent’s perception in the judgment of 12 July 2011, Hitachi and Others v Commission (T‑112/07, EU:T:2011:342), in order to establish the existence of potential competition. It follows in particular from paragraphs 90, 226 and 319 of that judgment, referred to in recital 1160 of the contested decision, that not only did the agreements at issue in that case between the European and Japanese producers constitute serious indicators that the Japanese producers were perceived by the European producers as potential credible competitors, they also showed that there were possibilities for the Japanese producers to penetrate the European market (see also, to that effect, judgment of 21 May 2014, Toshiba v Commission, T‑519/09, not published, EU:T:2014:263, paragraph 231). It is true that the General Court also carried out an objective analysis of potential competition, by examining inter alia the ability of the Japanese producers to enter the European market (judgment of 12 July 2011, Hitachi and Others v Commission, T‑112/07, EU:T:2011:342, paragraphs 157 and 160), as, moreover, the Commission pointed out in recital 1160 of the contested decision. However, that objective analysis only serves to demonstrate that the subjective criterion of the incumbent’s perception is only one criterion among others for assessing the existence of potential competition.

346

In the judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission (T‑360/09, EU:T:2012:332, paragraph 115), invoked by the applicants, the Court held that the existence of an agreement, and thus the perception of the parties to that agreement, was not enough, by itself, to demonstrate or did not necessarily imply the existence of potential competition at the date of signature of the agreement. Contrary to the applicants’ assertions, it was thus not concluded in that judgment that the criterion of the incumbent operator’s perception was irrelevant, but merely that that operator’s perception alone was not sufficient to establish the existence of potential competition in the absence of any other evidence capable of doing so.

347

It follows that, according to the case-law, the criterion of the incumbent operator’s perception is a relevant, but not sufficient, criterion for assessing the existence of potential competition. As the applicants rightly submit, given its subjective, and thus variable nature — which depends on the operators in question, their knowledge of the market and their contacts with their possible competitors — the perception of these operators, even experienced ones, cannot by itself lead to the conclusion that another operator is one of their potential competitors. However, that perception may support the conclusion that an operator has the ability to enter a market and, accordingly, may contribute to its classification as a potential competitor (see, to that effect, judgments of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraphs 103 and 104, and of 8 September 2016, Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission, T‑460/13, not published, under appeal, EU:T:2016:453, paragraph 88).

348

The applicants’ arguments directed against the Commission’s taking into account of the perception of incumbent operators in order to establish the existence of potential competition must therefore be rejected.

– The barriers to potential competition constituted by the applicants’ patents

349

The applicants and the intervener criticise the Commission for classifying the generic companies as potential competitors of Servier in spite of the barriers to their entry to the market constituted by the patents held by Servier.

350

In the contested decision, the Commission considered that the parties were wrong to contend, relying in particular on the judgment of 1 July 2010, AstraZeneca v Commission (T‑321/05, EU:T:2010:266, paragraph 362), that market entry was impossible because the existence of a patent excluded any possibility of competition, and to draw the conclusion that Servier’s patents created a ‘one-way blocking position’ within the meaning of the 2004 Guidelines on technology transfer agreements, which, moreover, were not applicable in the present case (recitals 1167 and 1168 and footnote 1638).

351

The Commission added that, in any event, first, the generic companies could contest the validity of Servier’s patents. It referred, in that respect, to the judgment of 25 February 1986, Windsurfing International v Commission (193/83, EU:C:1986:75, paragraph 92), according to which it is in the public interest to eliminate, inter alia by contesting the validity of the patents, any obstacle to economic activity which may arise where a patent was granted in error, and to the judgment of 6 December 2012, AstraZeneca v Commission (C‑457/10 P, EU:C:2012:770, paragraph 108), which stated that potential competition may exist even before the expiry of the compound patent (recitals 1132, 1165 and 1169 and footnote 1640 of the contested decision). The Commission added that the fact that Servier had alleged or was expected to allege infringements of its patents was inconclusive for the determination whether those patents were able to block the entry of generics, emphasising that there was no presumption of infringement and that, throughout the relevant period, no court decision had established such an infringement (recitals 1169 to 1171 of the contested decision). It stated that, with respect to the perceived possibility of invalidity or of infringement of Servier’s patents, it would rely on the assessments of the parties themselves, as well as third parties, as indicated in documents pre-dating or contemporaneous with the conclusion of the agreements at issue (recital 1172 of the decision).

352

The Commission took the view that, secondly, the generic companies could also use alternative routes to access the markets where litigation was taking place (recital 1175). The generic companies remained free to launch perindopril at risk, that is to say with the risk that the originator undertaking might bring an infringement action. The Commission noted, in that respect, that, given the practice of filing process patents following the expiry of the compound patent, virtually all sales after that expiry are at risk and that Apotex’s market entry at risk in 2006 resulted in a judgment invalidating the 947 patent and the award of damages against Servier (recitals 1176 and 1177 of the contested decision). Furthermore, the generic companies could have changed their processes, either directly or by switching to another API supplier, in order to avoid infringement claims. According to the Commission, while those changes in the manufacturing process might have engendered some regulatory delays, they represented a viable alternative route to the market (recital 1178 of the contested decision).

353

The Commission concluded, in recital 1179 of the contested decision, as follows:

‘... the settlements were concluded in a situation where the perindopril compound patent had expired, and all of the generic parties were involved, directly or indirectly, in legal actions or disputes concerning one or more of Servier’s remaining patents, whether in the form of a defence against claims of infringement or actions or counterclaims to invalidate such patents. Generics could also elect other patent related measures as potential avenues to the market. The Commission will examine in detail if generic undertakings seeking to overcome patent barriers and launch generic perindopril were a source of competitive pressure on Servier in spite of its patents. It may be recalled, in this respect, that all of the agreements covered by this Decision were concluded at a point in time where there was uncertainty whether any patent had been infringed and whether in particular the 947 patent could be invalidated. The mere existence, and enforcement, of Servier’s patents thus did not bar all scope for potential or actual competition.’

354

The applicants and the intervener argue, in essence, that that analysis by the Commission fails to take into account the effects, as provided for the legislation or established by case-law, of a patent declared or presumed to be valid. They also criticise the Commission for disregarding the 2004 and 2014 Guidelines on technology transfer agreements and certain considerations which the Commission expressed in its assessment of Servier’s abuse of a dominant position in the contested decision and in other decisions.

The failure to take into account the effects of Servier’s patents declared or presumed to be valid

355

According to the applicants and the intervener, a patent presumed to be valid constitutes, at the very least from the declaration of validity until its expiry, a legal prohibition on market entry preventing any potential competition.

356

However, it is clear from paragraph 108 of the judgment of 6 December 2012, AstraZeneca v Commission (C‑457/10 P, EU:C:2012:770), cited by the Commission in the contested decision (see paragraph 351 above), that potential competition may exist in a market even before the expiry of a patent. More specifically, the Court of Justice held that supplementary protection certificates which are intended to extend the protection conferred by a patent lead to significant exclusionary effects after the expiry of the patents, but that they were also liable to alter the structure of the market by adversely affecting potential competition even before that expiry, and that finding concerning the exertion of potential competition before the expiry of the patents was independent of the fact that the supplementary protection certificates at issue in that judgment had been obtained fraudulently or irregularly (judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 164). Accordingly, the exclusive right represented by the patent does not, as such, prevent potential competition from taking place during the exclusivity period in question.

357

Although, as the applicants and the intervener state, such an exclusive right normally has the effect of keeping competitors away, since public regulations require them to respect that exclusive right (judgment of 1 July 2010, AstraZeneca v Commission, T‑321/05, EU:T:2010:266, paragraph 362; see, also, paragraph 234 above), that competition-excluding effect concerns the actual competitors selling infringing products. A patent confers on its holder the exclusive right to use an invention with a view to manufacturing industrial products and putting them into circulation for the first time, as well as the right to oppose infringements (judgments of 31 October 1974, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraph 9, and of 16 July 2015, Huawei Technologies, C‑170/13, EU:C:2015:477, paragraph 46; see, also, paragraph 234 above), but does not, by itself, preclude operators from taking the necessary steps to be in a position to enter the relevant market following the expiry of the patent and, thus, exerting competitive pressure on the patent holder characteristic of the existence of potential competition before that expiry. Nor does it preclude operators from carrying out the actions necessary for the manufacture and marketing of a non-infringing product, as a result of which they may be regarded as actual competitors of the patent holder upon their market entry and, as the case may be, as potential competitors until that market entry (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 164).

358

That is particularly the case in the pharmaceutical sector, in which, under the legislation governing the grant of the marketing authorisations required in order to market a medicinal product, the competent authorities may grant a marketing authorisation for a generic product even if the reference product is protected by a patent. It follows from 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 2001 L 311, p. 67), as amended, that marketing authorisation applications for generic products may be dealt with in a shortened procedure based on the results of tests and trials submitted in the marketing authorisation application for the originator product and that the data relating to these results may be used and allow, consequently, the grant of a marketing authorisation before the expiry of the patent on the originator product (Article 10 of Directive 2001/83; see also recitals 74 and 75 of the contested decision). Thus, the legislation on the marketing of pharmaceutical products itself states that a generic company can enter the market with a lawfully granted marketing authorisation or, at the very least, begin the procedure for obtaining the marketing authorisation during the protection period of the originator undertaking’s patent. Contrary to the applicants’ submissions, the same is true in the national legislation transposing Directive 2001/83, since it is clear from the final report of 8 July 2009 of the Commission’s sector inquiry into the pharmaceutical sector, on which they rely, that the Slovak authorities amended their legislation to that effect and that the Hungarian authorities require only a ‘patent declaration’ whereby a generic company undertakes not to market an infringing product before the expiry of the patent in question. The fact, emphasised by the applicants, that an internal email from Servier states that ‘it seems that the perindopril dossiers [of certain generic companies] are blocked by [the Slovak regulatory authority] for as long as the 947 patent is in force’ cannot call that finding into question.

359

Furthermore, the system of protection of patents is designed in such a way that, although patents are presumed to be valid from the date of their registration (judgment of 1 July 2010, AstraZeneca v Commission, T‑321/05, EU:T:2010:266, paragraph 362), that presumption of validity does not automatically imply that all products placed on the market are infringing (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraphs 121 and 122). As the Commission rightly points out in the contested decision (see paragraph 351 above), and the applicants do not specifically dispute this, there is no presumption of infringement, since infringement must be established by a court. As can be seen from the judgment of 25 February 1986, Windsurfing International v Commission (193/83, EU:C:1986:75, paragraph 52), if a private operator which holds a patent could substitute its own discretion for that of the competent authority as regards the existence of an infringement of its patent, it could use that discretion in order to extend the protection of its patent (see also recital 1171 and footnote 1642 of the contested decision). It is therefore possible for an operator to take the risk of entering the market with a product, including by potentially infringing the patent in force, and that at risk entry or launch (see inter alia recitals 75 and 1176 of the contested decision) could be successful, if the patent holder decides not to bring an infringement action or, in the event that such an action is brought, if that infringement action is dismissed (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraphs 128 and 165). It should be pointed out, in that regard, that this possibility of entering the market at risk helps to demonstrate that patents do not constitute insurmountable barriers to the market entry of generic companies, but does not in itself imply that those companies have real concrete possibilities of entering that market, which depend on their ability and their intention to make such an at risk market entry.

360

Contrary to the intervener’s assertions, the Commission’s approach in that respect does not overturn the presumption of validity enjoyed by patents, by finding that potential competition exists, unless a court has confirmed the validity of the patent and a court has ruled that the valid patent was infringed. The intervener relies on an erroneous reading of the contested decision, since the Commission indicated in that decision, in essence and correctly (see paragraphs 357 to 359 above), not that the patent was presumed invalid until the adoption of a court decision relating to its validity and to the existence of an infringement, but that, until the adoption of such a decision, the presumption of validity of the patent did not prevent an at risk market entry (see recitals 1171 and 1176 of the contested decision).

361

It should be noted that the same lack of a presumption of infringement applies where the patent in question has been declared valid by a competent authority. Since a patent does not, as such, prevent the market entry of actual or potential competitors, the declaration of validity of that patent, if it is not accompanied by a declaration of infringement, does not preclude such competition. Accordingly, contrary to the applicants’ submissions, the fact that the EPO decision of 27 July 2006 declared the 947 patent valid is not in itself sufficient to prevent potential competition from taking place.

362

Those findings are not called into question by the case-law cited by the intervener.

363

First, the judgments of 15 September 1998, European Night Services and Others v Commission (T‑374/94, T‑375/94, T‑384/94 and T‑388/94, EU:T:1998:198), and of 29 June 2012, E.ON Ruhrgas and E.ON v Commission (T‑360/09, EU:T:2012:332), do not concern intellectual property rights, but rather exclusive rights precluding, de jure or de facto, the provision of the services at issue and access to infrastructure. In addition, even if it were considered that the ‘de facto territorial monopolies’ mentioned in the judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission (T‑360/09, EU:T:2012:332, paragraph 102), are not unlike the exclusive rights which patents constitute (see paragraph 234 above), it is clear from that judgment that the Court found that there was no potential competition, not because of the mere existence of those monopolies, but because the Commission had not demonstrated to the requisite legal standard that there were real concrete possibilities for another gas supplier to enter the German gas market despite those monopolies, thereby acknowledging that such monopolies did not suffice by themselves to preclude the existence of potential competition (see, to that effect, judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission, T‑360/09, EU:T:2012:332, paragraphs 103 to 107).

364

Secondly, although the judgments of 31 May 1979, Hugin Kassaregister and Hugin Cash Registers v Commission (22/78, EU:C:1979:138), and of 6 October 1994, Tetra Pak v Commission (T‑83/91, EU:T:1994:246), concern intellectual property rights and, in particular, as regards the latter, patents, it cannot however be inferred from those judgments that the patents and other intellectual property rights in question constituted insurmountable barriers to market entry precluding the existence of potential competition. In the judgment of 31 May 1979, Hugin Kassaregister and Hugin Cash Registers v Commission (22/78, EU:C:1979:138, paragraph 9), the Court of Justice found that a monopoly existed, as moreover the applicant in that case admitted, and thus the lack of effective competition on the market for spare parts for cash registers manufactured by that party, for a number of ‘commercial reasons’, including, but not limited to — as is, incidentally, more apparent from the report for the hearing in that case (p. 1885) — the United Kingdom legislation on designs and trade marks. Likewise, in the judgment of 6 October 1994, Tetra Pak v Commission (T‑83/91, EU:T:1994:246, paragraph 110), the General Court indeed held that the numerous patents at issue prevented new competitors from entering the market in aseptic machines. However, it cannot be inferred from this that the patents were regarded in themselves as insurmountable barriers to market entry on the market concerned, given the large number of patents at issue, emphasised by the Court, the existence of technological obstacles which were also taken into account in concluding that there were barriers to entry, and above all the presence of a competitor holding 10% of the market in question.

365

Nor are those findings called into question by Article 9(1) of Directive 2004/48, also referred to by the intervener, which provides that Member States are to ensure that the judicial authorities may issue against the alleged infringer an interlocutory injunction intended to prevent any imminent infringement of an intellectual property right or to forbid on a provisional basis the continuation of the alleged infringements of that right.

366

Such interlocutory or provisional injunctions indeed preclude the entry of an alleged infringer onto the market and thus the operation of real competition on that market for the period established by those injunctions. However, in view of that provisional nature, and in the absence of a final decision finding such an infringement and adopting the necessary corrective measures, such interlocutory or provisional injunctions are only temporary obstacles and not insurmountable barriers preventing steps being taken to market the allegedly infringing product and thus precluding the operation of potential competition.

367

Indeed, in the light of the limited time for analysis available to the competent authority to reach its decision and of the requirements laid down by Article 9(3) of Directive 2004/48 for the imposition of a provisional measure — in particular that the competent authority must satisfy itself with a sufficient degree of certainty that an intellectual property right is being infringed — the adoption of such provisional decisions is based only on a, necessarily summary, prima facie assessment of the alleged infringement, which must be confirmed or, where appropriate, invalidated following a more in-depth assessment of the conditions required to establish the existence of an infringement. Moreover, the generic companies concerned have the possibility of preventing the adoption of a decision against them, not only by submitting contrary arguments in the course of the proceedings on the merits, but also by challenging at the same time the validity of the patent at issue by way of a counterclaim for a declaration of invalidity of that patent. Accordingly, the granting of a provisional order or interim injunction, and a fortiori the mere risk of such an order or injunction being adopted, in the light in particular of the adoption of such interim decisions against other generic companies, cannot as such prevent a generic company actually or potentially affected by that type of decision from being a potential competitor.

368

Moreover, a judgment on the merits finding the existence of an infringement is itself provisional as long as the possible remedies have not been exhausted. Contrary to the intervener’s assertions, the Commission was entitled to take the view, in recitals 1132 and 1169 of the contested decision, that patent challenges and decisions in relation to these patents constituted an ‘expression of competition’ as regards patents. In view of the risk of infringement to which all generic companies are exposed and the fact that private operators are not competent to determine whether infringement has occurred (see paragraph 359 above), litigation is one of the means by which generic companies can reduce that risk and enter the market, either by obtaining a declaration of non-infringement or by having the potentially infringed patent declared invalid (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 122). It also follows that, as long as the generic company has the possibility to bring litigation to challenge the patents concerned and the infringement of them and thus clear a path to the market, it may be considered that those patents do not, in principle, constitute insurmountable barriers to access.

Failure to take into account the 2004 and 2014 Guidelines on technology transfer agreements

369

It cannot be considered that the 2004 and 2014 Guidelines on technology transfer agreements, assuming that they are applicable in the present case, were disregarded by the Commission in the contested decision.

370

First, contrary to the assertions of the applicants and the intervener, the decisions finding that the patents at issue were valid, and in particular the EPO decision of 27 July 2006, do not attest to a ‘blocking position’ resulting from the patents and regarded by the 2004 and 2014 Guidelines on technology transfer agreements as preventing potential competition from taking place. Indeed, in the 2004 Guidelines on technology transfer agreements (paragraph 32) and in the 2014 Guidelines on technology transfer agreements (paragraph 32), blocking positions are defined as situations in which an operator cannot enter the market without infringing the intellectual property rights of another operator. However, it should be recalled that decisions declaring the validity of a patent do not, on their own, prevent an at risk market entry and that this can be prevented only by a decision finding an infringement of the intellectual property right concerned, that is to say an infringement of the patent at issue (see paragraphs 359 and 361 above). Thus, the ‘court decisions’ referred to in the 2004 Guidelines on technology transfer agreements (paragraph 32) and the ‘final court decision[s]’ referred to in the 2014 Guidelines on technology transfer agreements (paragraph 33) as evidence of the existence of a blocking position refer not to decisions finding the validity of a patent but to decisions finding an infringement of that patent.

371

Secondly, contrary to the applicants’ submissions, nor has the Commission disregarded the recommendations in the 2014 Guidelines on technology transfer agreements concerning the analysis of potential competition in the absence of a blocking position established by a court decision. It should be recalled in that regard that, under paragraph 31 of the 2014 Guidelines on technology transfer agreements, an operator ‘can be considered a potential competitor on the product market if it is likely that, in the absence of the agreement, it would undertake the necessary additional investments to enter the relevant market in response to a small but permanent increase in product prices’ and ‘likely entry should be assessed on realistic grounds, that is to say based on the facts of the case at hand’. Moreover, according to paragraph 33 of those guidelines:

‘In the absence of certainty, for example in the form of a final court decision, that a blocking position exists, the parties, when addressing the question whether they are potential competitors, will have to base themselves on all the available evidence at the time, including the possibility that intellectual property rights are infringed and whether there are effective possibilities to work around existing intellectual property rights. Substantial investments already made or advanced plans to enter a particular market, can support the view that the parties are at least potential competitors, even if a blocking position cannot be excluded ...’

372

As is apparent from paragraphs 323 and 325 above, the Commission applied in the present case the real concrete possibilities criterion to establish whether the generic companies in question were potential competitors and thus relied, in accordance with the abovementioned paragraphs of the 2014 Guidelines on technology transfer agreements, not on the absence of impossibility of entry, but on the likelihood of entry assessed on realistic grounds and available information concerning, inter alia, the existence of any dispute between the parties, the state of development of their products and the steps taken by them to obtain marketing authorisation (see also paragraphs 432 to 438, 579 to 585 and 718 to 722 below). Moreover, in the event that the applicants’ arguments are to be interpreted as calling into question the Commission’s finding of the generic companies’ probability of entry onto the market, those arguments will be examined below in the context of the analysis of the complaints challenging the status of each of those companies as potential competitors.

373

It must also be added that, contrary to the intervener’s assertions, it is precisely as a result of that analysis of the generic companies’ probabilities of entry to the market, as required by the 2004 and 2014 Guidelines on technology transfer agreements and as carried out by the Commission, that the existence of potential competition is not inferred ipso facto from the absence of an established blocking position, but requires, in order to be demonstrated, a true analysis which could lead to a company being found not to be a potential competitor in spite of the absence of a blocking position resulting from the patents.

Inconsistency in the contested decision

374

According to the applicants, the Commission’s position is contrary to its findings in the contested decision relating to Servier’s abuse of a dominant position. In particular, they criticise the Commission for having, in a contradictory manner, recognised the exclusionary power of Servier’s patents in the part of the contested decision dedicated to the abuse of Servier’s dominant position (recitals 2572, 2857 and 2972) and ruled out the risk of the generic companies being excluded from the market as a result of those patents in the part of the contested decision relating to Article 101 TFEU.

375

That allegation of contradiction can be rejected at this stage, without it being necessary to rule on the Commission’s definition of the relevant markets in its analysis of the restrictive effects on competition of the agreements at issue and the abuse of Servier’s dominant position.

376

It should be pointed out, first, that, although the Commission did in fact conclude in the contested decision (recitals 2857 and 2972) that there was no actually viable source of competition on the market, the concept of viability used in those recitals to define the relevant market, namely the upstream technology market for the production of perindopril API, and to determine the existence of a dominant position on that market for the purposes of applying Article 102 TFEU differs from that used to determine the economically viable nature of a market entry in the context of the application of Article 101 TFEU. That concept of viability is more broadly understood as covering ‘economic and regulatory viability’ and that regulatory viability is strictly understood as being excluded where there is a patent on the market which prevents the technology in question being regarded as substitutable for that covered by the patent (footnote 3386 of the contested decision; see also recitals 2748 and 2754 of the contested decision). It may further be pointed out, for the purpose of ruling out the relevance in the present case of the assessments made by the Commission in recitals 2857 and 2972 of the contested decision, that they relate to the existence of actual and effective competition on the market in question, and not to the prospect of entry to the market of potential competitors.

377

It should also be pointed out, secondly, that in the other passages of the contested decision cited by the applicants and the intervener (recitals 2571 and 2572), devoted to defining the finished product market and determining whether Servier held a dominant position on that market, the Commission considered in essence that Servier’s patents were significant but not absolute barriers to market entry, in accordance with its assessment of the potential competition on that market.

The contradiction between the contested decision and other Commission decisions

378

According to the applicants and the intervener, the Commission’s position contradicts some of its previous decisions (Commission Decision 94/770/EC of 6 October 1994 relating to a proceeding pursuant to Article [101 TFEU] and Article 53 of the EEA Agreement (Case IV/34.776 — Pasteur Mérieux-Merck) and Commission Decision C(2013) 8535 final of 26 November 2013, relating to a proceeding under Article 6 of Council Regulation No 139/2004 (Case COMP/M.6944 — Thermo Fisher Scientific/Life Technologies)). Whereas, in those other decisions, the Commission concluded from the existence of patents or patent disputes that there was no significant competitive pressure from generic companies, in the contested decision it considered that, despite the existence of those same disputes that could lead to the generic companies’ market exclusion, those generic companies were potential competitors to Servier capable of exerting a significant competitive pressure on Servier’s perindopril.

379

It must be held, in that regard, that the contested decision does not, in any event, contradict the Commission decisions cited by the applicants and the intervener. It must be borne in mind, first of all, that since patents do not, in principle, constitute insurmountable barriers to the market entry of a competitor, but may give rise to such barriers depending on the outcome of patent litigation and have an impact on the real concrete possibilities of entering that market (see paragraph 359 to 368 above and paragraphs 442 to 453, 589 to 597 and 726 to735 below), it cannot be ruled out that the Commission could, in some of its decisions, including inter alia the two abovementioned decisions, have relied on the existence of patents in order to find a lack of potential competition. It should be noted, next, that in those two decisions, the Commission found the existence of barriers to market entry and the lack of potential competition by relying, not only on the existence of patents or patent disputes, but also on other factors, such as the difficulty of obtaining marketing authorisations, the size of the investments required or the existing commercial relationships, with the result that it cannot be inferred that the existence of patents or patent disputes precludes, as such, the operation of potential competition.

380

It follows from all the foregoing that the Commission did not err in finding that, in the present case, Servier’s patents were not insurmountable barriers to the market entry of the generic companies. At the time the agreements at issue were concluded, no final decision on the merits of an infringement action had found that the products of those companies were infringing.

381

It therefore remains to be examined whether the Commission also correctly considered that the generic undertakings had, given the particular characteristics of each, real concrete possibilities of entering the relevant market and, to that end, to respond to the arguments calling into question the existence of such possibilities put forward in the specific line of argument relating to each of the agreements at issue. It should be made clear at this stage that that examination of the complaints directed against the Commission’s assessment of the real concrete possibilities for generic undertakings to enter the market must be assessed in the light of the following four principles and considerations.

382

First, it is important to recall that it is apparent from the case-law relating to the determination of whether there are real concrete possibilities of entering a market (see paragraph 318 above) that the essential factor on which the description of an undertaking as a potential competitor must be based is whether it has the ability to enter that market and that its intention of entering that market, while relevant for the purposes of verifying whether it may be classified as a potential competitor, is used only on a supplementary basis. More specifically, while the intention to enter the market is neither necessary in order to find that there is potential competition on that market (judgment of 14 April 2011, Visa Europe and Visa International Service v Commission, T‑461/07, EU:T:2011:181, paragraph 169), nor capable of calling that finding into question, nevertheless, when such an intention is established, it may support the conclusion that a given operator has the ability to enter the market and thus contribute to its classification as a potential competitor.

383

It is also apparent that the criterion based on market entry representing an economically viable strategy, as required by that case-law, does not constitute an independent criterion separate from the main criterion of the ability to enter the market and from the supplementary criterion of the intention to enter that market (see, to that effect, judgment of 8 September 2016, Xellia Pharmaceuticals and Alpharma v Commission, T‑471/13, not published, under appeal, EU:T:2016:460, paragraph 81). On the one hand, that criterion is referred to in the judgments in question as an elaboration of the real and concrete nature of the possibilities of entry to the market and precedes the setting out of the main criterion of the ability of entering the market and the supplementary criterion of the intention to enter that market, presented as ‘necessarily result[ing]’ therefrom. On the other hand, those same judgments do not examine it distinctly and independently of verification of the ability and intention to enter the market, since it can reasonably be inferred from the fact that an undertaking has both the ability to enter the market — in the light of its means of production and marketing as well as its financial resources — and the intention to enter that market — having regard in particular to the prospects of profit and profitability — that that entry represents an economically viable strategy for the undertaking concerned.

384

Secondly, as the Commission rightly found in the contested decision (recital 1172; see also paragraph 351 above), the assessments of the parties themselves concerning the possibilities of the applicants’ patents being declared invalid or being infringed may be taken into account in order to determine whether the generic companies had real concrete possibilities of entering the market (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 141). In the absence of any decision by a public authority relating to the infringement and validity of Servier’s patents, the assessments of the parties themselves concerning the possibilities of those patents being declared invalid or being infringed are liable to shed light on those parties’ intentions as regards, amongst other things, litigation. In particular, when those assessments are made by generic companies, they may contribute to establishing their intention — taking into account their subjective perception of the patents concerned — of entering the market, but not their ability to enter as such, since establishing the infringement and invalidity of patents falls within the exclusive competence of the national courts and the EPO (see paragraph 243 and 359 above). Since intention is regarded as a relevant criterion for determining whether there are real concrete possibilities of entering the market (see paragraph 382 above), it follows that the parties’ subjective assessments may validly be taken into account for the purpose of establishing those possibilities. It must nevertheless be pointed out that, inasmuch as the intention of entering a market, while relevant for the purposes of verifying whether a company may be classified as a potential competitor, is used only on a supplementary basis, those assessments are also used only on a supplementary basis in determining whether that company constitutes a potential competitor. They must, moreover, be compared with other elements also capable of showing a company’s intentions as regards market entry.

385

Thirdly, the existence of real concrete possibilities of entering the market is assessed on the date of conclusion of the agreements at issue (see, to that effect, judgments of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraphs 138, 139 and 203, and of 8 September 2016, Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission, T‑460/13, not published, under appeal, EU:T:2016:453, paragraphs 94 and 95). In order to determine whether such agreements are restrictive of competition for the purposes of Article 101 TFEU, it is necessary to determine what actual or potential competition existed on the relevant market at the time the agreements were concluded. It follows that arguments and documents based on data subsequent to the conclusion of the agreements at issue cannot be taken into account, since such data reflect the implementation of those agreements and not the competitive situation on the market when they were concluded.

386

Fourthly, the burden of proving the existence of real concrete possibilities of a competitor entering the market, like the more general burden of proving the existence of an infringement (Article 2 of Regulation No 1/2003), rests with the Commission (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 105). Nevertheless, to the extent that most of the data which may be used to establish the ability and intention of generic undertakings to enter the market, and thus their real concrete possibilities of entering that market, are data internal to those undertakings, which the latter are best placed to gather, it must be held that the Commission has, in the absence of evidence to the contrary concerning technical, regulatory, commercial or financial difficulties, sufficiently established the existence of such possibilities in the circumstances of the case in question, if it has gathered a body of consistent evidence attesting, at the very least, to steps being taken to produce and market the product at issue within a sufficiently short period to form a constraint on the incumbent operator. It may be inferred from such steps that the company in question had not only the ability but also the intention to take the risk of entering the market (see, to that effect, paragraph 33 of the 2014 Guidelines on technology transfer agreements; see also, to that effect, judgment of 8 September 2016, Arrow Group and Arrow Generics v Commission, T‑467/13, not published, under appeal, EU:T:2016:450, paragraph 81).

(2) The criterion relating to the commitment of the generic companies to limit their independent efforts to enter the market

(i) Arguments of the parties

(ii) Findings of the Court

391

First, it must be noted that the Commission, in the contested decision, did not examine in isolation the general lawfulness of non-challenge and non-marketing clauses. It is apparent from recital 1154 of the contested decision that, in order to determine whether the agreements at issue constituted restrictions of competition by object, the Commission did not merely examine whether they contained non-challenge and non-marketing clauses, but also analysed whether the parties to the settlement were potential competitors and whether the non-challenge and non-marketing clauses were based on a transfer of value from the originator company to the generics company constituting an inducement, for the latter, not to exert competitive pressure on the company holding the patent. Consequently, the applicants and the intervener cannot criticise the Commission for having found that the mere presence of non-challenge and non-marketing clauses in a settlement suffices to establish its anticompetitive nature.

392

Next, as regards the arguments of the applicants and the intervener relating to the necessary presence of non-challenge and non-marketing clauses in any settlement, reference should be made to the considerations set out in paragraphs 258 to 275 above, setting out the conditions under which the Commission may establish the existence of a restriction by object where a settlement contains such clauses.

393

As regards the arguments of the applicants and the intervener relating to the application of the ancillary restraints doctrine in the present case, it is appropriate to reject those arguments by reference to paragraph 291 above.

394

As regards the applicants’ argument that the Commission has already regarded as unproblematic an agreement requiring a generic company to withdraw from the market pending the settlement of a parallel dispute, in exchange for compensation in the event that the litigation was unsuccessful, it is important to recall that, according to the case-law, the principle of equal treatment, which constitutes a general principle of EU law, requires that comparable situations must not be treated differently and that different situations must not be treated in the same way unless such treatment is objectively justified (judgments of 13 December 1984, Sermide, 106/83, EU:C:1984:394, paragraph 28, and of 14 May 1998, BPB de Eendracht v Commission, T‑311/94, EU:T:1998:93, paragraph 309).

395

It must be emphasised, however, that, when an undertaking has, by its conduct, infringed Article 101 TFEU, it cannot escape being penalised on the ground that another undertaking has not been fined. Even if the Commission had erred in considering that the Lundbeck-Neolab agreements were consistent with Article 101(1) TFEU, respect for the principle of equal treatment must be reconciled with respect for the principle of legality, according to which no person may rely, in support of his claim, on an unlawful act committed in favour of another (judgments of 31 March 1993, Ahlström Osakeyhtiö and Others v Commission, C‑89/85, C‑104/85, C‑114/85, C‑116/85, C‑117/85 and C‑125/85 to C‑129/85, EU:C:1993:120, paragraph 197, and of 14 July 1994, Parker Pen v Commission, T‑77/92, EU:T:1994:85, paragraph 86).

396

In any event, there are important differences between the agreements at issue and the Lundbeck-Neolab agreements, which the Commission described as unproblematic in the light of competition law in 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). Indeed, it is clear from recital 164 of that decision that Neolab entered the United Kingdom citalopram market in October 2002, that Lundbeck brought an action for infringement of one of its patents in November 2002 and that Neolab then lodged a counterclaim for invalidity of the patent at issue. In the context of a voluntary injunction granted in the course of the national court proceedings, Neolab undertook, by a first agreement, not to market its generic product until the judgment was delivered in a parallel case between Lundbeck and Lagap concerning the same patent or at the latest until 30 November 2003. In return, Lundbeck undertook to pay compensation to Neolab in the event of invalidation of the patent at issue. However, since Lundbeck reached a settlement with Lagap on 13 October 2003, Lundbeck and Neolab were released from their undertakings and Neolab resumed the sale of its generic product on 30 October 2003. On 22 December 2003, Neolab and Lundbeck, by a second agreement, concluded a settlement providing for the payment by Lundbeck to Neolab of damages as compensation for the inability to sell the generic product during the period covered by the voluntary injunction and containing an undertaking by both parties to the agreement not to pursue the litigation relating to the infringement and invalidity of the patent at issue until 31 March 2004.

397

As regards the first agreement, it differed from the agreements at issue in the present case, in so far as (i) it was concluded after the generic undertaking first entered the market, (ii) the restriction at issue appeared to result from an injunction granted in the context of court proceedings, (iii) the subject matter of the agreement was solely a non-marketing commitment of limited duration, namely pending settlement of the dispute having the same subject matter, and (iv) that agreement provided for the payment of damages by the originator company only in the event that its patent was declared invalid.

398

As regards the second agreement, although it indeed provided for a payment from the originator company to the generic company, it nevertheless also differed from the agreements at issue in that the generic company was already present on the market when that agreement was concluded and that agreement did not call into question that presence on the market. Moreover, the payment by the originator company to the generic company was intended only to compensate for the inability to sell the generic product during the period covered by the voluntary injunction and thus to prevent Neolab from bringing an action for damages on that basis.

399

Finally, as regards the applicants’ argument that the Commission must, in order to find that the interruption of litigation constitutes a restriction of competition, establish that the continuance of litigation is necessary and sufficient to maintain competition, it is necessary to recall that the determination of a restriction of competition by object (see paragraph 220 et seq. above) requires the Commission neither to assess the degree to which competition might be affected by the agreement at issue nor to establish that the continuance of litigation is necessary to maintain competition.

(3) The criterion relating to the transfer of value to the generic companies

(i) Arguments of the parties

(ii) Findings of the Court

406

It must be noted at the outset that the Commission did not consider in the contested decision that the mere presence of a transfer of value from the originator company to the generic company was sufficient, in itself, to prove the existence of a sufficient degree of harm to competition. It is apparent from recital 1154 of the contested decision that, in order to determine whether the agreements at issue constituted restrictions of competition by object, the Commission examined whether the parties to the settlements were potential competitors, whether those settlements included non-challenge and non-marketing clauses and whether the originator company had obtained the non-marketing and non-challenge undertaking from the generic company in return for a transfer of value (see also paragraphs 265 to 272 above).

407

Moreover, it is clear from paragraphs 265 to 273 above that, where a patent settlement is concluded between two potential competitors and contains non-marketing and non-challenge clauses, the existence of an inducement for the generic company to accept those clauses is, in itself, a basis for the finding of a restriction by object.

408

The arguments put forward by the applicants and the intervener do not allow that finding to be called in question.

409

First, as regards the argument that originator producers are required to make greater concessions in settlements than are required of generic companies, on account of the more significant litigation risks to which originator producers are exposed, it is necessary to bear in mind, as the Commission points out, that the applicants have not adduced any evidence to support that claim, and merely refer to their response to the statement of objections. Moreover, even assuming the existence of a more significant risk for the originator company, such a risk would not be such as to justify a reverse transfer of value constituting an inducement for the generic company to give up its efforts to enter the market.

410

As regards the intervener’s arguments that national pricing systems for medicinal products have an adverse effect on originator producers and that national judicial mechanisms do not provide an effective remedy to the entry of generic companies on the market at risk, it is important to recall that, assuming those facts to be established, they are not such as to justify an agreement having an anticompetitive object. According to settled case-law, it is 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 (judgment of 27 July 2005, Brasserie nationale and Others v Commission, T‑49/02 to T‑51/02, EU:T:2005:298, paragraph 81; see also, to that effect, judgment of 15 October 2002, Limburgse Vinyl Maatschappij and Others v Commission, C‑238/99 P, C‑244/99 P, C‑245/99 P, C‑247/99 P, C‑250/99 P to C‑252/99 P and C‑254/99 P, EU:C:2002:582, paragraphs 487 and 488).

411

As regards the applicants’ arguments that the Commission should have taken account of the commercial considerations and profit expectations of the parties to the settlements in order to assess the inducive nature of the transfer of value, it is apparent from paragraph 277 above that, in order to establish whether or not the transfer of value from the originator company to the generic company constitutes an inducement to accept non-marketing and non-challenge clauses, the Commission rightly examined whether the value transfer corresponded to the specific costs of the settlement for the generic company. The relevant criterion therefore involves identification of the costs borne by the generic company that are inherent in that settlement and not the taking into account of the commercial considerations of the parties to the settlement.

412

It should be added, as regards all the arguments referred to in the three preceding paragraphs, 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, Corus UK v Commission, T‑48/00, EU:T:2004:219, paragraph 73, and of 8 July 2004, Dalmine v Commission, T‑50/00, EU:T:2004:220, paragraph 211), in particular if that behaviour consists in paying actual or potential competitors not to enter the market (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraphs 379 and 380).

413

Secondly, the applicants cannot criticise the Commission for having derogated from the three criteria set out in recital 1154 of the contested decision by classifying agreements for the early entry of generic companies to the market as lawful, even though they include a significant inducement. It is clear from recitals 1138, 1200 and 1203 of the contested decision that the Commission merely noted that a settlement agreement authorising the entry of a generic company to the market before the expiry of the patent at issue could constitute an agreement which is favourable to competition and therefore lawful. However, in such an agreement, although the parties agree an early date for the entry of the generic product to the market, they do not provide for the originator company to grant an inducement to the generic company in order for that generic company to delay the entry of its product to the market.

414

Moreover, the applicants cannot criticise the Commission for having failed to investigate the 57 settlements listed in its annual monitoring exercises involving a transfer of value. On the one hand, it must be recalled that, when an undertaking has, by its conduct, infringed Article 101 TFEU, it cannot escape being penalised on the ground that another undertaking has not been fined, since respect for the principle of equal treatment must be reconciled with respect for the principle of legality, according to which no person may rely, in support of his claim, on an unlawful act committed in favour of another (see paragraph 395 above). On the other hand, a patent dispute settlement cannot be regarded as unlawful merely because it involves a transfer of value from the originator company to the generic company, an approach that was not adopted by the Commission in the contested decision, in which the Commission correctly examined whether the parties to the settlements were potential competitors, whether those settlements contained non-challenge and non-marketing clauses and whether the originator company had obtained the non-marketing and non-challenge undertakings from the generic company in exchange for a transfer of value (see paragraph 406 above).

415

Thirdly, the applicants criticise the Commission for having used a broad definition of significant value transfer, by taking into account side deals concluded at arm’s length. However, as the Commission rightly pointed out in recital 1190 of the contested decision, the inducement from the originator company to accept non-marketing and non-challenge clauses may take the form of a side deal to the settlement. Although side deals are normal commercial agreements, which may exist independently, the Commission, rightly, examined in the present case whether certain side deals forming an integral part of the dispute settlements at issue involved transfers of value from the patent holder to the generic company.

416

Fourthly, the applicants criticise the Commission for having taken into account the incentives of the generic company to continue litigation solely in the context of the analysis of the potential competition and not in the assessment of the transfer of value. However, it is apparent from paragraph 277 above that, in order to establish whether or not the transfer of value from the originator company to the generic company constituted an inducement to accept non-marketing and non-challenge clauses, the Commission rightly examined whether the value transfer corresponded to the specific costs of the settlement for the generic company. The relevant criterion therefore lies in the identification of the costs borne by the generic company that are inherent in that settlement and not in any asymmetry of information existing between the parties or in their respective commercial interests.

417

Finally, the applicants complain that the Commission disregarded certain contractual stipulations in the agreements concluded with Teva, Krka and Lupin which were likely to accelerate the entry of generic producers onto the market. That argument will be examined in the context of the pleas relating to the agreements at issue.

418

It follows from all the foregoing that the Commission correctly defined the three criteria used to classify the patent dispute settlements as restrictions by object and has not, therefore, committed any error of law relating to the concept of restriction of competition by object.

6.   The agreements concluded with Niche and Matrix

(a)   The status of Niche and Matrix as potential competitors

(b)   Errors of law and of assessment in relation to the classification of the Niche and Matrix agreements as restrictions of competition by object

(1) Arguments of the parties

(2) Findings of the Court

525

As regards the errors of law allegedly committed by the Commission in classifying the Niche and Matrix agreements as restrictions by object, without examining whether they were ‘so likely’ to have negative effects and therefore whether their potential effects were ambivalent (see paragraph 503 above), reference should be made to paragraphs 223 to 226, 304 to 306 and 418 above. As regards the ambivalent potential effects relied on by the applicants, based on the patent-related difficulties and the technical, regulatory and financial difficulties faced by Niche and Matrix, it should be added that those difficulties were properly considered by the Commission as not impeding Niche and Matrix’s real and concrete possibilities of competing with the applicants (see paragraph 501 above) and those difficulties therefore cannot support the conclusion that the Niche and Matrix agreements have ambivalent potential effects.

526

As regards the errors of assessment relied on, it is necessary to examine the applicants’ arguments relating to the presence in the Niche and Matrix agreements, on the one hand, of an inducement in the form of a benefit for Niche and Matrix and, on the other hand, of a corresponding limitation of their efforts to compete with the originator company, conditions which, if fulfilled, require a finding of the existence of a restriction by object (see paragraph 272 above). It must be pointed out in that regard that the applicants do not call into question the existence of non-marketing and non-challenge clauses in the Niche and Matrix agreements, which are by themselves restrictive of competition (see paragraph 257 above), but argue that those clauses do not reveal a sufficient degree of harm in the present case and dispute that the transfers of value provided for by the Niche and Matrix agreements may be regarded as inducive value transfers.

(i) The absence of inducive value transfer

527

It should be noted, as a preliminary point, that the mere presence of a transfer of value from the originator company to the generic company cannot lead to the conclusion that there is a restriction by object. Only where an unjustified reverse payment occurs in the conclusion of the settlement, that is to say where the generic company is induced by that payment to agree to the non-marketing and non-challenge clauses, must it be concluded that there is such a restriction. In that case, the restrictions of competition introduced by the non-marketing and non-challenge clauses no longer relate to the patent and to the settlement, but rather can be explained by the inducement (see paragraph 265 above).

528

In order to establish whether or not a reverse payment, that is to say a transfer of value from the originator company to the generic company, constitutes an inducement to accept non-marketing and non-challenge clauses, it is necessary to examine, taking into account its nature and its justification, whether the transfer of value covers costs inherent in the settlement of the dispute (see paragraph 277 above). In the contested decision, the Commission therefore rightly examined whether the value transfer provided for in the Niche and Matrix agreements corresponded to the specific costs of the settlement for the generic company (recitals 1333 to 1337 and 1461 to 1464 of the contested decision).

529

If a reverse payment provided for in a settlement agreement containing clauses restrictive of competition is aimed at compensating costs borne by the generic company that are inherent in that settlement, that payment cannot in principle be regarded as an inducement. Nevertheless, a finding of an inducement and of a restriction of competition by object is not ruled out in such a case. It means however that the Commission must prove that the amounts corresponding to those costs inherent in the settlement, even if they are established and precisely quantified by the parties to that settlement, are excessive (see paragraph 278 above).

530

The costs inherent in the settlement of the dispute include, in particular, litigation expenses incurred by the generic undertaking in the context of the dispute between it and the originator company. The compensation of those costs is directly linked to that settlement. Consequently, where the litigation expenses of the generic company are established by the parties to the settlement, the Commission can find them to be inducive only by showing that they are disproportionate (see paragraph 279 above).

531

By contrast, some costs incumbent upon the generic company are, a priori, too extraneous to the dispute and to its settlement to be regarded as inherent in the settlement of a patent dispute. Those include, for example, the costs of manufacturing the infringing products, corresponding to the value of the stock of those products, and research and development expenses incurred in developing those products. The same is true of sums which must be paid by the generic undertaking to third parties as a result of contractual commitments which were not undertaken in the context of the dispute (for example supply contracts). It is therefore for the parties to the agreement, if they do not wish the payment of those costs to be regarded as an inducement, and indicative of a restriction of competition by object, to demonstrate that those costs are inherent in the dispute or in its settlement, and then to justify the amount. They could also, to the same end, invoke the insignificant amount of the repayment of those costs which are a priori not inherent in the settlement of the dispute, showing that that amount is insufficient to constitute a significant inducement to accept the clauses restricting competition stipulated in the settlement agreement (see paragraph 280 above).

532

In the present case, as regards the Niche agreement and as the Commission correctly observed in recital 1322 of the contested decision, the existence of such an inducement is clear from the actual wording of the agreement, which states in Clause 13 that, ‘in consideration for the undertakings set out [in the agreement], and the substantial costs and potential liabilities that may be incurred by Niche and Unichem as a consequence of ceasing their programme to develop and manufacture Perindopril made using the Process [at issue], Servier shall pay Niche and Unichem … the sum of [GBP] 11 800 000.00’. The undertakings given are the non-marketing and non-challenge clauses, payment for which is thus expressly provided for in Clause 13.

533

That interpretation of the wording of the Niche agreement is, moreover, not called into question by the applicants’ claim that the phrase ‘in consideration for’ is the standard formula in English law to indicate the reciprocity necessary for the validity of any contract. Even if it were concluded that that phrase is a kind of stylistic formula to which it would not be appropriate to attach significance, the fact remains that that formula, according to the applicants themselves, indicates reciprocity and thus the fact that the sum provided for in Article 13 of the Niche agreement is given in exchange for the obligations imposed on Niche by that agreement.

534

Nor is that interpretation of the Niche agreement invalidated by the alleged asymmetry between the risks for the originator company and those to which the generic company is exposed or by the alleged negotiating talents of Niche. It is true that such an asymmetry of risks and the negotiating talents of the generic company may partly explain why the originator company may be led to grant significant reverse payments to the generic company. However, the grant of a significant payment is intended precisely to avoid all risk, even minimal, that the generic companies may enter the market and, thus, supports the finding that the originator company has paid in order to side-line the generic companies. It must also be noted that the fact that the adoption of anticompetitive conduct may prove to be the most profitable or least risky solution for an undertaking, or that it is intended to correct an imbalance detrimental to that undertaking, in no way precludes the application of Article 101 TFEU (see, to that effect, judgments of 8 July 2004, Corus UK v Commission, T‑48/00, EU:T:2004:219, paragraph 73; of 8 July 2004, Dalmine v Commission, T‑50/00, EU:T:2004:220, paragraph 211; and of 27 July 2005, Brasserie nationale and Others v Commission, T‑49/02 to T‑51/02, EU:T:2005:298, paragraph 81), in particular if that behaviour consists in paying actual or potential competitors not to enter the market (judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraphs 379 and 380).

535

Furthermore, it is irrelevant in this case that Clause 13 of the Niche agreement stipulates that the payment of the sum of GBP 11.8 million is consideration not only for the non-marketing and non-challenge clauses, but also — in some undefined proportion — consideration for other expenses, since that other compensation does not call into question the finding that the restrictive clauses at issue were purchased by the applicants and, thus, the existence of an inducement for Niche to accept those clauses.

536

Those other expenses, described in the Niche agreement as ‘substantial costs and potential liabilities that may be incurred by Niche and Unichem as a consequence of ceasing their programme to develop Perindopril made using the Process [at issue]’, were described by Niche, during the administrative procedure (recital 1326 of the contested decision), and by the applicants themselves, in their pleadings, as covering the costs of developing Niche’s perindopril and the compensation due to Niche’s customers for breach of its contractual obligations to them. Such costs are not, a priori, inherent in the settlement of a patent dispute (see paragraph 531 above) and the applicants fail to establish that they are inherent in the settlement concluded in the present case.

537

In particular, even if, as the applicants argue in essence, the compensation payable to Niche’s customers would not have been payable if Niche had pursued its litigation against the applicants, such compensation is in the present case too extraneous to the dispute and to its settlement to be regarded as costs inherent in that settlement, since that compensation was payable, according to the applicants, in the event of ‘voluntary termination of the project’, implying termination of the contracts with their customers, and the Niche agreement gave Niche the option of merely suspending, rather than terminating, contractual relations with its customers (Clause 11 of the Niche agreement). Moreover, the applicants themselves conceded at the hearing that the compensation in question might have had to be paid to Niche’s customers irrespective of the Niche agreement. It may also be noted that the information provided by the applicants to contest the amount of that compensation, as assessed by the Commission in the contested decision at GBP 1.3 million (recital 1335), is not conclusive, since it indicates either sums lower than that amount or mere claims of higher sums.

538

As regards ‘the legal costs’ referred to in the contested decision (recital 1334), Niche described them during the administrative procedure as relating to legal costs included in the costs of development (recital 601 of the contested decision), which, it should be recalled, are not inherent in the settlement (see paragraph 531 above), whereas the applicants describe them as ‘lawyers’ fees and patent fees’, which may constitute litigation expenses inherent in the settlement (see paragraph 530 above). However, even assuming that the amount of GBP 1.1 million claimed for ‘lawyers’ fees and patent fees’ is a litigation expense the reimbursement of which may, in principle, reasonably be provided for in a settlement, that amount cannot form part of the costs inherent in the settlement concluded in the present case. It is clear from the arguments and documents produced by the applicants that the costs in question related to a period until the end of 2003, that is to say prior to the start of the litigation between Niche and the applicants (see paragraphs 11, 13 and 16 above) which was brought to an end by the Niche agreement.

539

It may be added, for the sake of completeness, that even if that amount of GBP 1.1 million were to be added to the development costs and costs of compensation to Niche’s customers assessed, respectively, at GBP 1.2 million and 1.3 million by the Commission in the contested decision (recital 1336), without those amounts being validly contested by the applicants (see in particular paragraph 537 above), the total amount resulting (GBP 3.6 million) is clearly less than GBP 11.8 million.

540

It follows that the Commission validly found, in the contested decision (recital 1348), that the Niche agreement contained an inducement for Niche to accept the non-marketing and non-challenge clauses set out in that agreement, and the Commission was not also required, as the applicants maintain (see paragraph 513 above), to ascertain whether those clauses would have been less restrictive in scope in the absence of that inducive payment. A finding that there was an inducement to accept non-marketing and non-challenge clauses requires only the existence of such clauses — irrespective of whether they are more or less restrictive in scope — and an analysis of the costs covered by the transfer of value in question (see paragraphs 528 to 531 above).

541

It also follows that it is necessary to reject as ineffective the complaint alleging that the Commission committed an error of assessment in declaring that the amount paid to Niche pursuant to the Niche agreement was equivalent to more than 10 years of planned sales and more than 20 years of planned gross profit (see paragraph 514 above). Even if the Commission committed such an error, it has no bearing on the classification of the transfer of value from the applicants to Niche as an inducement, since it is clear from paragraphs 536 to 538 above that that transfer of value did not cover the costs inherent in the settlement of the dispute and it is in no way claimed, nor a fortiori established, that the amount of that transfer was insignificant and thus insufficient to qualify as an inducement.

542

Moreover, as regards the additional inducement resulting from the amount paid to Niche pursuant to the Biogaran agreement (recitals 1349 to 1354 of the contested decision), it is necessary to consider, as will be set out in detail in paragraphs 798 to 810 below, that the fact that a commercial agreement, which does not normally have the settlement of a dispute as its subject matter, and which serves as a vehicle for a transfer of value from the originator company to the generic company, is linked with a settlement agreement containing competition-restricting clauses is a strong indication of the existence of a ‘reverse payment’, that is to say of a transfer of value for which there is no real consideration under that commercial side deal (see paragraph 804 below), a payment which therefore also constitutes an inducive benefit if it is not intended to compensate for costs inherent in the settlement of the dispute. Where there is information or evidence put forward by the Commission in order to support such a strong indication and thereby establish the existence of a reverse payment, the parties to the agreements may present their version of the facts, supporting their claims with the evidence that they are able to provide and which permit the conclusion that the commercial agreement, although linked to the settlement agreement, is justified by reasons other than the exclusion of a competitor by means of a reverse payment.

543

In the present case, the Commission has put forward several items of evidence showing the existence of a link between the Niche agreement and the Biogaran agreement and of a mismatch between the transfer of value provided for by the Biogaran agreement and the obligations imposed on Niche by that agreement. First, the Commission took into account the fact that the agreements were negotiated during the same period and were concluded between the same undertakings on the same date as well as the fact that both agreements provided for a payment in two instalments, on the same dates. Secondly, while the applicants argued that there was no link between the two agreements, Niche stated that the Biogaran agreement had been proposed by the applicants in order to provide Niche with ‘the total overall consideration agreed for entering into the Global Settlement Agreement’. The Commission also interpreted an email sent by Biogaran’s counsel to Niche on 4 February 2005, stating that ‘in consideration of the amount at stake we find it necessary to have further rights on additional products and certain freedom on the supply side of the Products’, as meaning that the amount to be transferred to Niche had been fixed before the parties agreed on the scope of the products covered by the Biogaran agreement. The Commission also considered that the contractual provisions of the Biogaran agreement, and in particular Clauses 14.4 and 14.5 thereof, provided for automatic termination of that agreement in the event of a failure to obtain marketing authorisations within 18 months, without Biogaran having any entitlement to compensation from Niche, contrary to the provisions contained in other agreements concluded by Biogaran relating to the acquisition of product dossiers. Finally, the Commission noted that, with the exception of one product, Biogaran had not obtained marketing authorisations on the basis of the dossiers transferred by Niche and that Biogaran’s turnover connected with the Biogaran agreement had amounted to between EUR 100000 and 200000.

544

The applicants do not put forward any argument calling into question that analysis, with the exception of a complaint alleging that Biogaran’s interest in concluding the Biogaran agreement was not taken into account. Apart from the fact that such an interest cannot be regarded as sufficient to justify the amount of the transfer of value provided for by the Biogaran agreement, it may be noted that recital 1351 of the contested decision reveals a number of findings which cast doubt on the existence of such an interest on the part of Biogaran. According to those findings, which are not disputed by the applicants, the amount which was to be transferred to Niche by Biogaran had been decided before Niche and Biogaran agreed on the products covered by the Biogaran agreement, that agreement could be terminated by the parties within 18 months without either party being entitled to compensation and no provision was made for any reimbursement to Biogaran in the event that the transferred marketing authorisations were not obtained within a certain period. Accordingly, the Commission was right to consider that the Biogaran agreement constituted an additional inducement for Niche to accept the restrictive clauses of the Niche agreement.

545

Moreover, as regards the applicants’ claims seeking to be allowed to benefit from any annulment of the contested decision or from any reduction in the amount of the fine which Biogaran might obtain in Case T‑677/14, it is appropriate to refer to paragraphs 89 to 99 above.

546

As regards the Matrix agreement, it should be noted that Clause 9 thereof is similar to Clause 13 of the Niche agreement and that it is therefore necessary to reject, for the same reasons, the arguments criticising the Commission’s assessments concerning the Matrix agreement in the same way as the assessments concerning the Niche agreement. As regards the argument, specifically directed against the Commission’s analysis of the Matrix agreement, that the compensation of Niche’s customers was also of concern to Matrix, on the basis of its joint liability with Niche, it is necessary to recall that such costs cannot be regarded as costs inherent in the settlement of a dispute (see paragraph 531 above) and, accordingly, justify the transfer of value provided for by the Matrix agreement, especially since neither the applicants nor Matrix were in a position to establish that the amount of GBP 11.8 million covered such costs or other costs inherent in the settlement of the dispute.

547

It follows that the Commission also validly found, in the contested decision (see, in particular, recitals 1452, 1453, 1463, 1464 and 1467), that the Matrix agreement included an inducement for Matrix to agree to the non-marketing and non-challenge clauses provided for by that agreement.

(ii) The non-challenge and non-marketing clauses were not sufficiently harmful

548

It should be noted that the applicants do not dispute the existence of non-challenge and non-marketing clauses in the Niche and Matrix agreements.

549

Under the non-challenge clauses contained in the Niche and Matrix agreements, those two companies had to abstain from any invalidity and non-infringement actions against the 339, 340, 341, 689, 947 and 948 patents, and Niche was also required to withdraw its oppositions to the 947 and 948 patents before the EPO (Clauses 7 and 8 of the Niche agreement and Clause 5 of the Matrix agreement). Under the non-marketing clauses contained in the Niche and Matrix agreements, those two undertakings were to refrain from making, keeping, importing, supplying, offering to supply or disposing of perindopril and from carrying out an act likely to infringe the 339 to 341 patents concerning perindopril (Clause 3 of the Niche agreement and Clause 1 of the Matrix agreement). They also had to refrain from applying for marketing authorisations for perindopril (Clause 10 of the Niche agreement and Clause 6 of the Matrix agreement) and were obliged to terminate or suspend their contracts relating to perindopril concluded with third parties (Clause 11 of the Niche agreement and Clause 7 of the Matrix agreement).

550

However, the applicants dispute that the non-challenge and non-marketing clauses contained in the Niche and Matrix agreements were sufficiently harmful or significant in nature.

551

In the first place, they argue that the non-challenge and non-marketing clauses are inherent in the settlement agreements.

552

Although non-challenge and non-marketing clauses are indeed necessary for the settlement of certain patent disputes (see paragraph 259 above), it should be recalled that such clauses lose their legitimacy and reveal a sufficient degree of harm to normal competition where it is the inducement, such as that found in the present case, and not the recognition of the validity of the patents at issue by the parties, which is the real cause of the restrictions of competition introduced by those clauses (see paragraph 270 above).

553

It should also be noted — in response to the applicants’ argument that the loss of the opportunity to have a dispute settled in one’s favour which is entailed by the non-challenge clause cannot be sufficient to classify an agreement intended to settle a genuine dispute as a restriction by object (see paragraph 505 above) — that, while not precluding entry to the market as such, the non-challenge clause prevents inter alia litigation intended to ‘clear the way’ in the context of an at-risk launch and thus the use of one of the means to allow such entry to the market (see also paragraph 257 above). It is also important to recall that the Commission, in the present case, classified as a restriction by object not merely the non-challenge clauses contained in the Niche and Matrix agreements, but those agreements in their entirety, including the non-challenge clauses and non-marketing clauses and an inducement to accept such clauses (recitals 1375 and 1481 of the contested decision).

554

The applicants submit, in the second place, that the non-challenge and non-marketing clauses contained in the Niche and Matrix agreements do not reveal a sufficient degree of harm, in that their effects derive from the existence of the patents at issue and not from the terms of those agreements.

555

In that regard, it should be recalled that the existence of an inducement for the generic undertaking to agree to non-marketing and non-challenge clauses supports a finding of a restriction by object, even though the settlement includes clauses having a scope not exceeding that of the patent at issue (see paragraph 273 above). Thus, even if, as the applicants claim, the non-marketing clauses do not prevent Niche and Matrix from entering the market with a non-infringing product and are limited to the effects produced by an injunction for infringement of the patents at issue, or even allow those companies, as a result also of the amount received in the context of the transfer of value, to undertake with their partners the development of a new non-infringing perindopril project (see paragraph 506 above), the Niche and Matrix agreements nonetheless constitute a restriction by object.

556

In the third place, the applicants dispute that the non-challenge clauses are sufficiently harmful in nature, claiming that they concerned only one of the many opponents who brought opposition proceedings against the 947 patent before the EPO and had no effect on the other generic undertakings on account of the limitation of the litigation to that concerning the infringement.

557

It must be held that even if the claims that the Niche and Matrix agreements had effects only on the generic undertakings party to those agreements were established, those claims would not call into question the exclusion of those companies from the market imposed by the non-marketing and non-challenge clauses in return for an inducive value transfer and, thus, the sufficient degree of harm of the agreements concerned, thereby rendering the examination of their specific effects superfluous.

558

It follows that the Commission did not wrongly consider that the Niche and Matrix agreements were restrictive of competition by object.

559

That conclusion is not called into question by the alleged errors of assessment made by the Commission in the presentation of the economic and legal context of the Niche and Matrix agreements and in its consideration of the parties’ subjective intentions.

560

Indeed, the applicants’ allegation concerning the lack of anticompetitive intent and the pursuit of legitimate objectives of the parties to the Niche and Matrix agreements, which in particular led Niche to take the initiative in contacting the applicants, is not capable of calling into question either the existence of an inducive benefit or the anticompetitive nature of the non-marketing and non-challenge clauses in the agreements. Consequently, even if the arguments in question had an established factual basis, they would not be capable, in any event, of invalidating the Commission’s finding that the Niche and Matrix agreements constituted restrictions by object.

561

It should also be added that the parties’ intention is not a necessary factor in determining whether a type of coordination between undertakings is restrictive (see paragraph 222 above).

562

In addition, since the Niche and Matrix agreements contained non-marketing and non-challenge clauses, the inherently restrictive nature of which has not been validly called into question, and since the Commission found that there was an inducement, it could correctly regard those agreements as market exclusion agreements, which thus pursued an anticompetitive objective. According to settled case-law, the mere fact that an agreement also pursues legitimate objectives is not enough to preclude the classification of that agreement as a restriction of competition by object (see paragraph 222 above).

563

As regards the alleged errors of assessment made by the Commission in taking into account the economic and legal context of the Niche and Matrix agreements, the applicants repeat, in that regard, their arguments criticising the ability and the intention of Niche and Matrix to enter the market, having regard, in particular, to the applicants’ patents and the disputes relating to those patents as well as Niche’s financial and regulatory difficulties (see paragraphs 507 and 519 above). Since those arguments were examined and rejected in the context of the plea challenging the status of Niche and Matrix as potential competitors (see paragraphs 432 to 501 above), they cannot call into question the nature of the Niche and Matrix agreements as restrictions by object.

564

It follows from the foregoing that the plea alleging errors of law and of assessment in relation to the classification of the Niche and Matrix agreements as restrictions of competition by object must be rejected in its entirety.

(c)   Errors of law and of assessment in relation to the classification of the Niche and Matrix agreements as restrictions of competition by effect

565

The applicants maintain that the Commission made various errors of law and of assessment in relation to the classification of the Niche and Matrix agreements as restrictions of competition by effect.

566

It should be borne in mind that where some of the grounds in a decision on their own provide a sufficient legal basis for the decision, any errors in the other grounds of the decision have no effect on its operative part. Moreover, where the operative part of a Commission decision is based on several pillars of reasoning, each of which would in itself be sufficient to justify that operative part, that decision should, in principle, be annulled by the Court only if each of those pillars is vitiated by an illegality. In such a case, an error or other illegality which affects only one of the pillars of reasoning cannot be sufficient to justify annulment of the decision at issue because that error could not have had a decisive effect on the operative part adopted by the Commission (see judgment of 14 December 2005, General Electric v Commission, T‑210/01, EU:T:2005:456, paragraphs 42 and 43 and the case-law cited).

567

As noted in paragraph 219 above, in deciding whether an agreement is prohibited by Article 101(1) TFEU, there is no need to take account of its actual effects once it is apparent that its object is to prevent, restrict or distort competition within the internal market.

568

Consequently, where the Commission bases a finding of infringement both on the existence of a restriction by object and on the existence of a restriction by effect, an error rendering unlawful the ground based on the existence of a restriction by effect does not, in any event, have a decisive effect on the operative part adopted by the Commission in its decision, since the ground based on the existence of a restriction by object, which can by itself justify the finding of an infringement, is not vitiated by an illegality.

569

In the present case, it is clear from the examination of the plea alleging errors of law and of assessment in relation to the classification of the Niche and Matrix agreements as restrictions of competition by object that the applicants have not shown that the Commission erred in concluding, in the contested decision, that the agreements in question had as their object the prevention, restriction or distortion of competition within the internal market, within the meaning of Article 101(1) TFEU.

570

The present plea in law must therefore be rejected as ineffective.

7.   The agreement concluded with Teva

(a)   The status of Teva as a potential competitor

(b)   Errors of law and of assessment in relation to the classification of the Teva agreement as a restriction of competition by object

(1) Arguments of the parties

(2) Findings of the Court

643

It is necessary to examine the applicants’ arguments relating to the presence in the Teva agreement, first, of an inducement in the form of a benefit for Teva and, secondly, of a corresponding limitation of Teva’s efforts to compete with the originator company, conditions which, if fulfilled, require a finding of the existence of a restriction by object (see paragraph 272 above). In the present case, since the finding of an inducement depends in part on the restrictive nature of certain clauses in the Teva agreement, the complaints directed against the assessment of the clauses of the agreement will be examined in the first place, before those criticising the assessment of the value transfer provided for in that agreement. As regards the alternative complaint concerning the duration of the applicants’ alleged infringement on the basis of the Teva agreement, it will be examined last.

(i) The absence of a limitation of the generic company’s efforts to compete with the originator company

644

As a preliminary point, it is necessary to reject the applicants’ allegations of errors of law and of assessment made by the Commission in classifying the Teva agreement as a restriction by object, although its potential effects were pro-competitive and its restrictive effects purely hypothetical (see paragraph 634 above). It must of course be recalled that the Commission and the Courts of the European Union cannot, when examining whether an agreement restricts competition by object and, in particular, in assessing the economic and legal context of that agreement, completely ignore its potential effects (see case-law cited in paragraph 304 above). However, it is also apparent from the case-law that establishing the existence of a restriction of competition by object cannot, under the guise, inter alia, of the examination of the economic and legal context of the agreement at issue, lead to the assessment of the effects of that agreement, since otherwise the distinction between a restriction of competition by object and by effect laid down in Article 101(1) TFEU would lose its effectiveness (see paragraph 221 above). For the purposes of verifying the specific capability of an agreement to produce competition-restricting effects characteristic of agreements with an anticompetitive object, the analysis of the potential effects of an agreement must therefore be limited to those resulting from information objectively foreseeable at the time of the conclusion of that agreement (see, to that effect, Opinion of Advocate General Wahl in ING Pensii, C‑172/14, EU:C:2015:272, point 84; see also, to that effect, judgment of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraphs 80 to 82). In the present case, the alleged potential effects, whether they are non-restrictive of competition or pro-competitive, are based on hypothetical circumstances which were therefore not foreseeable at the time of the conclusion of the Teva agreement, such as the decision of the EPO concerning the validity of the 947 patent or the entry of other generic companies into the United Kingdom market, which cannot be taken into account in assessing whether that agreement is restrictive of competition by object (see also paragraphs 667 and 668 below).

645

As regards, next, the claims that the clauses of the Teva agreement are not by nature intrinsically anticompetitive, it should be recalled, in the first place, that the fact that non-challenge and non-marketing clauses are inherent in settlements does not prevent settlement agreements which include such clauses from being classified as restrictions of competition by object (see paragraph 273 above). It may be added that, although the applicants claim that the ancillary restraints doctrine is applicable to the Teva agreement, on the ground that its non-challenge and non-marketing clauses are necessary and proportionate to the settlement of the dispute in question, it has already been held that that link of necessity and proportionality could be broken in the event of a finding that there is an inducement to accept such clauses (see paragraph 291 above). Thus, that doctrine could be applied to the Teva agreement only if the transfer of value provided for by that agreement did not constitute an inducement (see paragraphs 679 to 699 below).

646

It must be considered, in the second place, that the arguments put forward by the applicants do not call into question the restrictive nature of the non-challenge clause in the Teva agreement.

647

Under that clause, Teva undertook not to challenge the 947 and 339 to 341 patents in the United Kingdom for the duration of the Teva agreement, it being stipulated that it was not prevented from continuing opposition proceedings against those patents before the EPO (Clause 2.4 of the Teva agreement).

648

The Commission considered, in the contested decision, that that non-challenge clause had two main consequences: first, it prevented Teva from establishing that the product it intended to market was non-infringing and, secondly, it prevented an objective legal review of the validity of the applicants’ patents in the United Kingdom (recital 1546).

649

It must be noted, first of all, that the applicants do not dispute that first consequence of the non-challenge clause contained in the Teva agreement, but maintain that such a consequence is inherent in any non-challenge clause contained in a settlement (see paragraph 625 above). It must be borne in mind, in that regard, that the fact that such a clause is inherent in the settlement is not in itself sufficient to preclude the finding of an anticompetitive objective (see paragraphs 273 and 645 above).

650

It must be held, next, that it is irrelevant in the present case that the non-challenge clause covers only litigation in the United Kingdom and does not include proceedings before the EPO, since the territorial scope of the Teva agreement is limited to the United Kingdom, within which any challenge to the validity of the 947 patent and the process patents is prohibited. It should be borne in mind, in that respect, that an agreement may be classified as a restriction by object, even if its territorial scope is limited to one Member State (see, to that effect, judgment of 24 September 2009, Erste Group Bank and Others v Commission, C‑125/07 P, C‑133/07 P and C‑137/07 P, EU:C:2009:576, paragraph 38 and the case-law cited).

651

Moreover, even if, as the applicants argue, the non-challenge clause were not capable of affecting the proceedings for the revocation of the 947 patent initiated in the United Kingdom by a subsidiary of Teva, proceedings which were suspended pending a final decision in the opposition proceedings before the EPO not covered by the Teva agreement, that clause nevertheless prevents, at the very least, the introduction of other invalidity actions against that patent for the term of the Teva agreement and, under Clause 2.4 of that agreement, that prohibition applies to both Teva UK Ltd and its subsidiaries and both to direct actions and to any assistance to a third party with a view to invalidating the applicants’ patents. Teva’s active participation in the opposition proceedings before the EPO, inter alia by the notification of the decisions of the United Kingdom courts concerning the validity of the 947 patent, as alleged by the applicants (see paragraph 635 above), is therefore irrelevant in the present case.

652

Nor can the Commission be criticised for not having established that there was a serious basis for calling into question the validity of the applicants’ process patents (see paragraph 635 above). Such evidence is not required to establish the restrictive nature of a non-challenge clause, which depends on the elimination of real concrete possibilities of overcoming patent-related obstacles, which, in order to be established, do not necessarily presuppose evidence of the likely success of the action for invalidity of the patents concerned (see paragraph 368 above).

653

Lastly, the applicants’ claim that the non-challenge clause did not prevent third parties from challenging their patents (see paragraph 635 above) is irrelevant. Indeed, such a claim that the Teva agreement had potential effects solely on that generic company does not call into question, as such, the restrictive nature of the non-challenge clause contained in the Teva agreement (see also paragraphs 556 and 557 above).

654

It must be held, in the third place, that the exclusive purchasing clause was rightly classified by the Commission as restrictive of competition.

655

That clause, as provided for in Clause 3 of the Teva agreement, reads as follows:

‘3. Exclusive purchasing obligation

3.1.   For the duration of this Agreement, Teva shall purchase all Teva and its Affiliates’ requirements for Perindopril for supply or disposal in the United Kingdom exclusively from Servier or Servier’s Affiliates.

3.3.   Teva shall not, and shall procure that its Affiliates shall not, actively sell or promote Product to consumers outside the United Kingdom.

3.4.   Subject to receipt by Servier or its Affiliates of confirmed orders from Teva for the quantities of Product set out below, submitted on or before the Order Dates, Servier or its Affiliates shall supply Teva with the following quantities of Product by the following dates:

3.4.1. 150000 (one hundred and fifty thousand) packs of 30, 2 mg tablets by 1 August 2006 and in subsequent months 75000 (seventy five thousand) such packs per month;

3.4.2. 240000 (two hundred and forty thousand) packs of 30, 4 mg tablets by 1 August 2006 and in subsequent months 120000 (one hundred and twenty thousand) such packs per month; and

3.4.3. 80000 (eighty thousand) packs of 30, 8 mg tablets by 1 January 2007 (or such date as the parties may agree) and in subsequent months 40000 (forty thousand) such packs per month.

3.8.   If, in respect of any month during the term of this Agreement:

3.8.1. Servier has received from Teva confirmed orders for Product, for delivery for the United Kingdom during such month, such confirmed orders having been submitted on or before the relevant Order Dates; and

3.8.2. Servier and its Affiliates have, within ten Working Days of the delivery date thereof, failed to deliver to Teva the total Product ordered by Teva in accordance with the provisions of Clause 3.4 and 3.8.1 for delivery during such month,

3.8.3. Servier shall, subject to Clause 3.9 pay Teva the Liquidated Damages in respect of that month and Teva and its Affiliates shall have no other right or remedy (including any right of termination) in respect of any failure by Servier to supply Product to Teva.

…’

656

It must also be borne in mind that, under the non-marketing clause laid down in Clause 2.3 of the Teva agreement, Teva was to refrain, in the United Kingdom, from making, having made, keeping, importing, supplying, offering to supply or disposing of generic perindopril either manufactured in accordance with the process it had developed, and which Servier regarded as infringing the 947 and 339 to 341 patents, or infringing those patents until the termination or expiration of the Teva agreement or the expiration of those patents.

657

The Commission considered, in recitals 1552 to 1555 of the contested decision, that, since the non-marketing clause (Clause 2.3) and the exclusive purchasing clause (Clause 3.1) of the Teva agreement affected Teva’s ability to compete or to choose independently its source of perindopril for supply on the United Kingdom market, those clauses should be analysed together as a single non-compete obligation. It stated that, whatever the patent situation of the possible alternative sources of perindopril (infringing or non-infringing), the only options left open to Teva by the exclusive purchasing clause were either to sell Servier’s product exclusively, or to receive compensation for failure to supply (liquidated damages of GBP 500000 per month of default).

658

It must be pointed out that the applicants’ arguments challenging the Commission’s assessment in that respect are based on an erroneous interpretation of the exclusive purchasing clause of the Teva agreement.

659

It is apparent from the Teva agreement that there was an alternative between supply and the payment of damages in the event of a failure to supply, since, alongside the obligation to supply, which is indeed mentioned as such in Clause 3.4 of the Teva agreement, that agreement envisaged the possibility of non-supply, which could not be challenged before a court, would not enable Teva to terminate the agreement, and was not even subject to any conditions, such as a temporal limitation, other than the payment of damages (Clauses 3.8.2, 3.8.3 and 8.3 of the Teva agreement).

660

It should be noted that the prohibition of challenges and of termination in the event of failure to supply provided for in Clause 3.8.3 of the Teva agreement (‘the non-termination clause’) played a decisive role in that interpretation of the exclusive purchase clause, since it replaced the penalisation of a breach of a contractual obligation by a court or by the termination of the contractual relationship with pre-established pecuniary compensation and thus created an alternative between supply and damages. In that regard, it is irrelevant whether those damages result from a breach of the supply obligation or from a possibility for Servier not to supply Teva.

661

The result is, in any event, as the Commission rightly considered in the contested decision (recital 1559), a non-supply option, left entirely to Servier’s discretion, which prevented Teva from entering the market and which also distinguishes the clauses concerned from the clauses typically contained in a supply agreement.

662

By contrast, Teva was subject to an exclusive purchasing obligation, rightly described as an ‘absolute’ obligation by the Commission (recital 1588 of the contested decision), since Teva could not withdraw from it in order to source perindopril from other perindopril suppliers — whether that perindopril was infringing or not — and enter the market with that perindopril, even if Servier failed to supply, since, under the non-termination clause, the agreement could not be terminated on that basis. As the Commission rightly stated in recital 1557 of the contested decision, the non-termination clause, combined with the exclusive purchasing clause, obliged Teva to source generic perindopril exclusively from Servier, and thus prevented it from sourcing from other suppliers, including those that did not infringe any of Servier’s patents.

663

It follows that the exclusive purchasing and non-termination clauses not only overlap with the non-marketing obligation laid down in Clause 2.3 of the Teva agreement, since they prohibit the acquisition and, accordingly, the sale of perindopril produced by third parties that infringes the patents at issue, but also extend that obligation beyond the patents at issue, since they prohibit the acquisition and the sale of perindopril produced by third parties that does not infringe the patents at issue.

664

It follows that the Teva agreement’s exclusive purchasing and non-termination clauses are, by themselves, particularly capable of preventing Teva from procuring and thus entering the market with a third party’s product, just as that entry is moreover already prevented both as regards the applicants’ products and those of third parties by the non-marketing clause set out in Clause 2.3 of the agreement, the competition-restricting nature of which is not disputed by the applicants.

665

It must also be held that the limitation of the exclusive purchasing clause and of the non-marketing clause to perindopril erbumine cannot call into question their restrictive nature (see paragraph 626 above).

666

The applicants point out that those clauses related only to perindopril erbumine and do not dispute that the product which Teva intended to market at the time of the conclusion of the Teva agreement was perindopril erbumine. Thus, the non-marketing and exclusive purchasing clauses prevented Teva from entering the market with perindopril erbumine, which it was planning to market for the duration of the Teva agreement. Therefore, even if Teva could have entered the market with perindopril composed of a salt other than erbumine during the period covered by the Teva agreement, the fact remains that that agreement prevented Teva from competing with the applicants using perindopril erbumine and restricted competition in that respect. In addition, it may be noted that the evidence submitted by the applicants to establish Teva’s entry into the United Kingdom market with a salt other than erbumine concerns information subsequent to the expiry of the Teva agreement.

667

The claims of the applicants concerning the ambivalent potential effects of the exclusive purchasing clause are also irrelevant in the present case (see paragraph 636 above). It must be borne in mind that such potential effects, based, in the present case, on circumstances which were not foreseeable when the Teva agreement was concluded, cannot be taken into account in assessing whether that agreement is restrictive of competition by object (see paragraph 644 above). It may be added that, in any event, contrary to the applicants’ submissions, it cannot be considered that the alleged potential effects of the Teva agreement were not restrictive of competition, or indeed pro-competitive.

668

If the 947 patent had been invalidated by the EPO, the Teva agreement would have prevented Teva from entering the market with its product or that of Krka by virtue of the non-marketing clause, which would have remained in force — as shown by the reference to the ‘expiration’ of the patents in Clause 2.3 of the Teva agreement, as opposed to the term ‘revocation’ used in Clause II of the amendment to the Teva agreement — even though that invalidation would have allowed the market entry of generic products that potentially infringed that patent. In addition, even if the applicants supplied Teva with generic perindopril in that situation, as they assert (see paragraph 616 above), that market entry of Teva with the applicants’ generic product would not have created a situation of competition as regards the applicants and Teva would not, moreover, have been the sole, and thus the first, market entrant given the abovementioned entry of other generic companies. Likewise, in the event that the validity of the 947 patent had been confirmed by the EPO, Teva would still have been prevented from obtaining generic perindopril, including non-infringing generic perindopril, from any undertakings other than the applicants, and its supply by the applicants, even more hypothetical in that case, as they themselves recognise (see paragraph 636 above), would also not have allowed it to enter into competition with the applicants. It must be added, in that latter regard, that the fact that the Commission set the end of the infringement on the date that Teva had entered the United Kingdom market with the applicants’ product cannot be interpreted as acknowledgement, by the Commission, that Teva entered the market in July 2007 in competition with the applicants. The Commission itself indicated in the contested decision (recitals 2125 and 3133) that the end date of the infringement was set at 6 July 2007 in order to adopt a conservative approach and to use a date which would be favourable to the parties to the agreement.

669

For the same reasons, the applicants’ allegations concerning their intention to supply Teva in the event that the 947 patent was invalidated by the EPO and Teva’s objective of early entry, or even entry as the first generic company, to the United Kingdom market are also irrelevant in the present case.

670

Lastly, the Commission cannot be criticised (see paragraph 624 above) for relying, solely for the purposes of supporting its analysis, on the interpretation of the Teva agreement carried out by the High Court of Justice (England & Wales), Chancery Division (Patents Court), in its judgment of 9 October 2008 (recitals 1572 and 1573 of the contested decision).

671

It follows from all the foregoing that the Commission did not erroneously assess the exclusive purchasing and non-termination clauses in the Teva agreement in considering that those two clauses, combined in the non-marketing clause set out in Clause 2.3 of the Teva agreement, had to be analysed together as a ‘non-compete obligation’ (recital 1552 of the contested decision) and, thus, as an overall non-marketing obligation imposed on Teva.

672

It follows that, contrary to what the applicants essentially submit, those clauses do not correspond to those typically set out in a supply agreement, nor to those in a typical exclusive purchasing agreement (see also paragraphs 661 and 662 above), and cannot therefore be analysed in the same way as clauses contained in a side deal to a settlement, since such side deals correspond to typical commercial agreements (see paragraphs 798 to 808 below).

673

It also follows that the applicants’ arguments based on typical supply agreements or exclusive purchasing agreements must be rejected.

674

In particular, the applicants’ allegation that such agreements are a common practice in the pharmaceutical sector is irrelevant in the present case, since the exclusive purchasing clause of the agreement does not correspond to the typical clauses mentioned by the applicants. It should be added that, in any event, practices of private undertakings cannot prevail in the application of the competition rules set out in the Treaty, even where they are tolerated or approved by the authorities of a Member State (see, to that effect, judgment of 17 January 1984, VBVB and VBBB v Commission, 43/82 and 63/82, EU:C:1984:9, paragraph 40).

675

Nor is Regulation No 2790/1999 relevant, especially since, under Article 2(4) thereof, it does not apply to exclusivity agreements concluded by competing undertakings, such as those in question in the present case, both of which are seeking to market perindopril under their own name. Indeed, it has been found that Teva was a potential competitor of the applicants (see paragraph 614 above) and that status is not called into question by the conclusion of an agreement usually concluded between undertakings operating at different levels of the production or distribution chain.

676

As regards the Commission’s assessment of the Servier/Generics agreement concluded less than a year after the Teva agreement, it should be noted that the Commission found, in recital 745 of the contested decision, without being contradicted by the applicants, that the exclusive purchasing clause contained in the Servier/Generics agreement did not provide for any payment or damages in the event of failure to supply by the applicants. Moreover, it is clear from the file that nor was that clause combined with a non-termination clause and a non-marketing clause, since Generics had not developed any competing perindopril, with the result that the assessments relating to that agreement could not be transposed to the Teva agreement.

677

Finally, in so far as the Commission clearly identified the specific and, in the present case, problematic aspects of the exclusive purchasing clause in the Teva agreement (see, in particular, recitals 1553 to 1574 of the contested decision), it cannot be inferred from the contested decision that the Commission prohibited, in principle, any concurrent conclusion of an exclusive distribution agreement and a settlement agreement.

678

It follows from all the foregoing that the Commission rightly considered that the Teva agreement restricted Teva’s efforts to compete with the applicants.

(ii) The absence of an inducement in the form of a benefit

679

The Commission considered, in the contested decision, that the lump sum of GBP 5 million (‘the lump sum’) and the liquidated damages of GBP 500000 per month totalling GBP 5.5 million for the 11 months of non-supply by Servier (‘the final liquidated damages’), represented a substantial sum of money — GBP 10.5 million — which had served as a significant inducement for Teva to refrain from competing with the applicants (recital 1622).

680

In order to establish whether or not a reverse payment, that is to say a transfer of value from the originator company to the generic company, constitutes an inducement to accept non-marketing and non-challenge clauses, it is necessary to examine, taking into account its nature and its justification, whether the transfer of value covers only costs inherent in the settlement of the dispute. In the contested decision, the Commission therefore rightly examined whether the value transfer corresponded to the specific costs of the settlement for the generic company (see recitals 1592 to 1599 of the contested decision).

681

If a reverse payment provided for in a settlement agreement containing clauses restrictive of competition is aimed at compensating costs borne by the generic company that are inherent in that settlement, that payment cannot in principle be regarded as an inducement. Nevertheless, a finding of an inducement and of a restriction of competition by object is not ruled out in such a case. It means however that the Commission must prove that the amounts corresponding to those costs inherent in the settlement, even if they are established and precisely quantified by the parties to that settlement, are excessive (see paragraph 278 above).

682

The costs inherent in the settlement of the dispute include, in particular, litigation expenses incurred by the generic undertaking in the context of the dispute between it and the originator company. The compensation of those costs is directly linked to that settlement. Consequently, where the litigation expenses of the generic company are established by the parties to the settlement, the Commission can find them to be inducive only by showing that they are disproportionate (see paragraph 279 above).

683

By contrast, some costs incumbent upon the generic company are, a priori, too extraneous to the dispute and to its settlement to be regarded as inherent in the settlement of a patent dispute. Those include, for example, the costs of manufacturing the infringing products, corresponding to the value of the stock of those products, and research and development expenses incurred in developing those products. The same is true of sums which must be paid by the generic undertaking to third parties as a result of contractual commitments which were not undertaken in the context of the dispute (for example supply contracts). It is therefore for the parties to the agreement, if they do not wish the payment of those costs to be regarded as an inducement, and indicative of a restriction of competition by object, to demonstrate that those costs are inherent in the dispute or in its settlement, and then to justify the amount. They could also, to the same end, invoke the insignificant amount of the repayment of those costs which are a priori not inherent in the settlement of the dispute, showing that that amount is insufficient to constitute a significant inducement to accept the clauses restricting competition stipulated in the settlement agreement (see paragraph 280 above).

– The final liquidated damages

684

Contrary to the applicants’ submissions, the Commission rightly considered that the final liquidated damages represented a payment made to Teva in exchange for its commitment not to compete with Servier (recital 1588 of the contested decision) and, accordingly, an inducement to accept a non-marketing obligation. The Commission rightly considered that the exclusive purchasing and non-termination clauses of the Teva agreement amounted to the imposition of a non-marketing obligation excluding Teva from the market (see paragraph 671 above) and, since Clauses 1.8 and 3.8.3 of the agreement provided for the payment of liquidated damages of GBP 500000 per month in the event that Servier failed to supply the product and that market exclusion thus materialised, the liquidated damages clearly constitute the quid pro quo for Teva’s not entering the market.

685

In that respect, the applicants’ argument that the liquidated damages are a traditional contractual arrangement in English law and reflect what could have been granted by a court for non-compliance with a supply obligation must be rejected as irrelevant. The existence of an inducement may be inferred in the present case from the fact that the payment was made, not in order to compensate for costs inherent in the settlement agreement or in the performance of a normal supply agreement, but as a quid pro quo for Teva’s not entering the market as provided for in the abovementioned clauses, irrespective of the legal mechanism used to achieve that quid pro quo and of whether that quid pro quo corresponds to the damages that a court would have granted (see paragraphs 680 and 681 above).

686

Nor is the applicants’ comparison with the Commission’s assessment relating to the Lundbeck-Neolab agreements (see paragraphs 394 to 398 above) capable of calling into question the nature of the final liquidated damages as an inducement.

– The lump sum

687

The arguments put forward by the applicants as regards the lump sum, provided for in Clause 10.1 of the Teva agreement, do not call into question the Commission’s finding of an inducement.

688

It should be noted, in that respect, that Clause 10.1 of the Teva agreement stipulates as follows:

‘Servier shall, subject to receipt of an appropriate invoice from Teva, pay or procure that one of its Affiliates shall pay, Teva [GBP] 5000000 … within 10 Working Days of receipt of Teva’s invoice. Such invoice may be raised on signature of this Agreement and will be due immediately, always provided that Servier shall have 10 Working Days to make payment. Such payment shall be a contribution towards the costs incurred by Teva in preparing to enter into this Agreement, including without limitation the costs of terminating its supply arrangements for the United Kingdom.’

689

In the contested decision, the Commission found, as a preliminary point, that no specific amount had been reported by Teva ex post for the various costs alleged to have been compensated by the lump sum, with the exception of legal costs of less than EUR 100000 for the litigation brought by Ivax against Servier in the United Kingdom (recitals 1594 and 1597). It nevertheless evaluated the other costs liable, in its view, to fall within the scope of Clause 10.1 of the Teva agreement, including those corresponding to the value of Teva’s perindopril stock that had to be destroyed and to Teva’s perindopril development costs, and found that they represented in total less than 40% of the lump sum (recitals 1596 to 1599 of the contested decision).

690

It follows that the Commission considered that, even though some of the costs covered by Clause 10.1 of the Teva agreement could be regarded as inherent in the settlement of the dispute between the applicants and Teva, the latter had not quantified the costs in question, nor a fortiori established the amount of those costs, with the exception of legal costs that had been quantified, but in an approximate way and without establishing the amount of those costs. In the contested decision, the Commission referred to the fact that Teva only ‘reported’ (recital 797) or ‘submitted’ (recital 1597) legal costs of ‘less than EUR 100000’ and confirmed, in response to a question asked at the hearing, that Teva had not submitted any evidence with its estimated figure.

691

The applicants do not put forward any argument, nor a fortiori adduce any evidence, such as the ‘appropriate invoice’ mentioned in Clause 10.1 of the agreement, capable of calling into question the Commission’s analysis in that respect.

692

First, the applicants merely refer to ‘the destruction of stock’ and indicate its value. However, compensation for the value of stock to be destroyed cannot, a priori, be described as costs inherent in a settlement (see paragraphs 280 and 683 above).

693

In any event, the applicants fail to establish the value of that stock. On the one hand, the amount in euros claimed by them does not correspond to the amount in pounds sterling referred to in the contested decision (recital 1596), having regard to the exchange rate used by the Commission (see, in particular, footnote 4109 of the contested decision). On the other hand, and above all, the applicants adduce no evidence in support of their claim other than their own statements and those of Teva in reply to the statement of objections, as well as a document from Teva making no reference to any specific figure. Thus, even if it were to be considered that, in the present case, payment of the value of the stock of Teva products to be destroyed was inherent in the Teva agreement, in that that destruction was provided for by that agreement (Article 2.2), that payment could not, in the absence of evidence of its amount, avoid being classified as an inducive payment (see paragraph 683 above).

694

The applicants refer, secondly, to the sum of GBP 1 million which Teva contemplated having to pay to one of its commercial partners as a result of the termination of the commercial partnership in question. In addition to the fact that the sums to be paid by the generic undertaking to third parties by reason of the termination of ongoing contracts are not a priori costs inherent in a settlement (see paragraph 683 above), it may be noted that the alleged amount is nowhere set out in the contract in question annexed to the application.

695

Although the applicants claim, thirdly, that the initial amount corresponded to the damages which they would have had to pay Teva in the event that an injunction was wrongly granted and which they would have avoided paying by virtue of the Teva agreement, it must be noted that, by that allegation, the applicants seek, in essence, to prove that the lump sum was justified by comparing that sum to the amount of costs of a different nature which are not covered by Article 10.1 of the agreement. That provision — although drafted in a non-restrictive manner — is limited to the ‘costs incurred by Teva’ and does not include costs incurred or avoided by the applicants. By their allegation, the applicants also confuse the issue whether the lump sum is justified in the light of the settlement, which is the only settlement at issue in the present case, and the issue of the proportionality of that amount; the proposed comparison might in certain circumstances be relevant for assessing the latter. However, it should be noted that they are two separate assessments that the Commission must carry out in turn. Thus, it is for the Commission, when assessing the restrictive nature of a patent dispute settlement involving a value transfer, to examine, in the first place, whether the costs covered by the value transfer are justified in the light of the settlement and, in particular, whether the value transfer corresponds to the established amount of costs which may by their very nature be regarded as inherent in the settlement, then, in the second place, if it considers those costs are justified, to verify that the amount of those costs is not disproportionate in view of, inter alia, the type of costs concerned (see paragraphs 681 and 682 above).

696

It should also be noted that, even if the proposed comparison were relevant for the purpose of ascertaining whether the lump sum was justified in the light of the settlement, the applicants have not provided any assessment of the costs allegedly avoided. They merely refer to substantial damages in the event of a decision against them in the substantive proceedings which follow the grant of an injunction in their favour.

697

Finally, in so far as the applicants maintain, fourthly, that the initial amount was intended to ‘secure’ the exclusive purchasing clause (see paragraph 628 above), it must be concluded that they regard that amount as a quid pro quo for that clause and thus, essentially acknowledge that it is an inducement, since that clause has been interpreted as imposing a non-marketing obligation on Teva (see paragraphs 684 and 685 above).

698

It follows that the Commission validly found, in the contested decision (recitals 1608 and 1622), that the Teva agreement contained an inducement for Teva to accept the non-marketing and non-challenge clauses set out in that agreement, and the Commission was not also required to ascertain, as the applicants maintain (see paragraph 628 above), whether those clauses would have been less restrictive in scope in the absence of that inducive payment. A finding that there was an inducement to accept non-marketing and non-challenge clauses requires only the existence of such clauses — irrespective of whether they are more or less restrictive in scope — and an analysis of the costs covered by the transfer of value in question (see paragraphs 680 and 681 above).

699

The existence of that inducement is not capable of being called into question by the applicants’ allegation that the Commission wrongly ‘conflated’ the initial amount and the final liquidated damages in order to infer ‘a net value transfer for the amount of GBP 10.5 million’. Admittedly, as the applicants rightly point out, unlike the initial amount determined by Clause 10.1 of the Teva agreement, the amount of the final liquidated damages results from the implementation of the Teva agreement, in particular from the applicants’ failure to supply Teva, and not, with respect to an amount of GBP 5.5 million thereof, from the relevant clause of the agreement providing solely for monthly compensation of GBP 500000. However, although it may be inferred that the amount of GBP 10.5 million corresponds to the amount of the transfer of value actually paid to Teva and not to the amount of the transfer of value arising solely from the clauses of the Teva agreement, the fact remains that, for the same reasons as those that led to the conclusion that the initial amount and the monthly compensation of GBP 500000 were an inducement, the full amount of that actual transfer also constitutes an inducement.

700

It follows that, in view of the foregoing (see, in particular, paragraphs 265 to 271 above), the Commission rightly inferred from the finding of that inducement, the two parts of which were provided for in the Teva agreement, that that agreement restricted competition by object.

701

That conclusion is not called into question by the alleged distortion of the objective of the Teva agreement and of the intentions of the parties to that agreement.

702

The applicants’ allegation that the parties to the Teva agreement lack anticompetitive intent and that the agreement pursues legitimate objectives, including inter alia Teva’s early entry — or even entry as the first generic company — to the United Kingdom market, is not capable of calling into question either the existence of an inducive benefit or the competition-restricting nature of the non-marketing and non-challenge clauses in the Teva agreement (see also paragraph 669 above). Consequently, even if the arguments in question had an established factual basis, they would not be capable, in any event, of invalidating the Commission’s finding that the Teva agreement constituted a restriction by object.

703

It should also be added that the parties’ intention is not a necessary factor in determining whether a type of coordination between undertakings is restrictive (see paragraph 222 above).

704

In addition, since the Teva agreement contained non-marketing and non-challenge clauses, the inherently restrictive nature of which has not been validly called into question, and since the Commission found that there was an inducement, it could correctly regard the Teva agreement as a market exclusion agreement, which thus pursued an anticompetitive objective. According to settled case-law, the mere fact that an agreement also pursues legitimate objectives is not enough to preclude the classification of that agreement as a restriction of competition by object (see paragraph 222 above).

(iii) The alternative complaint concerning the duration of the infringement

705

The applicants criticise the Commission for having fixed the start of the infringement alleged against them based on the Teva agreement on the date that that agreement was concluded (13 June 2006), instead of on the date on which Teva obtained the marketing authorisation in the United Kingdom (12 December 2006) (see paragraph 641 above).

706

It should be recalled, in that regard, that, on the one hand, the examination of conditions of competition and the restrictions imposed on that competition must be based not only on existing competition between undertakings already present on the market but also on potential competition between those established undertakings and other undertakings not yet present on the market (see judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission, T‑360/09, EU:T:2012:332, paragraph 85 and the case-law cited) and that, on the other hand, the Commission rightly found that Teva was a potential competitor of the applicants on the date that the Teva agreement was concluded (see paragraph 614 above), even though it did not have a marketing authorisation on that date (see paragraphs 478 and 599 above). It follows that the Commission did not err in considering that competition was restricted as soon as the Teva agreement was concluded on 13 June 2006 and that the infringement alleged against the applicants on the basis of that agreement started on that date.

707

The complaint criticising the Commission’s assessment of the duration of the infringement found to have occurred on the basis of the Teva agreement must therefore be rejected, as must the plea alleging errors of law and of assessment in classifying the Teva agreement as a restriction by object.

(c)   Errors of law and of assessment in relation to the classification of the Teva agreement as a restriction of competition by effect

708

The applicants maintain that the Commission made various errors of law and of assessment in relation to the classification of the Teva agreement as a restriction of competition by effect.

709

It is appropriate, in applying mutatis mutandis the considerations set out in paragraphs 566 to 570 above, to reject the present plea as ineffective.

8.   The agreement concluded with Lupin

(a)   The status of Lupin as a potential competitor

(b)   Errors of law and of assessment in relation to the classification of the agreement concluded with Lupin as a restriction of competition by object

(1) Arguments of the parties

(2) Findings of the Court

787

As regards the plea relating to the actual finding of the infringement, it is necessary to examine, in the first place, the applicants’ arguments seeking to call into question the two conditions for a finding of a restriction by object, that is to say an inducement in the form of a benefit for the generic company and the corresponding limitation of its efforts to compete with the originator company. It will next be necessary to consider whether the Commission could properly conclude that there was an infringement. Finally, it will be necessary to ensure that the Commission did not err in the definition of the scope ratione materiae of that infringement.

788

As regards the plea relating to the duration of the infringement, on which the applicants relied in the alternative, it will be examined last.

(i) The absence of an inducive benefit

789

It follows from Article 2 of Regulation No 1/2003 and from settled case-law that, in the field of competition law, where there is a dispute as to the existence of an infringement, it is incumbent on the Commission to prove the infringements found by it and to adduce evidence capable of demonstrating to the requisite legal standard the existence of the circumstances constituting an infringement (judgments of 17 December 1998, Baustahlgewebe v Commission, C‑185/95 P, EU:C:1998:608, paragraph 58, and of 8 July 1999, Commission v Anic Partecipazioni, C‑49/92 P, EU:C:1999:356, paragraph 86; see, also, judgment of 12 April 2013, CISAC v Commission, T‑442/08, EU:T:2013:188, paragraph 91 and the case-law cited).

790

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 of 12 April 2013, CISAC v Commission, T‑442/08, EU:T:2013:188, paragraph 92 and the case-law cited).

791

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. 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 judgment of 12 April 2013, CISAC v Commission, T‑442/08, EU:T:2013:188, paragraph 93 and the case-law cited).

792

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 of 12 April 2013, CISAC v Commission, T‑442/08, EU:T:2013:188, paragraph 95 and the case-law cited).

793

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 of 12 April 2013, CISAC v Commission, T‑442/08, EU:T:2013:188, paragraph 96 and the case-law cited).

794

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 Commission, viewed as a whole, meets that requirement (see judgment of 12 April 2013, CISAC v Commission, T‑442/08, EU:T:2013:188, paragraph 97 and the case-law cited).

795

The existence of an anticompetitive practice or agreement must sometimes even be inferred from a number of coincidences and indicia which, taken together, may, in the absence of another plausible explanation, constitute evidence of an infringement of the competition rules (judgment of 7 January 2004, 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, EU:C:2004:6, paragraph 57).

796

For example, although parallel behaviour may not by itself be identified with a concerted practice, it may however amount to strong evidence of such a practice if it leads to conditions of competition which do not correspond to the normal conditions of the market (judgment of 14 July 1972, Farbenfabriken Bayer v Commission, 51/69, EU:C:1972:72, paragraph 25).

797

Likewise, the presence of a ‘side deal’ — the expression used by the Commission in recital 1190 of the contested decision — may constitute, as regards the settlement of a patent dispute, a strong indication of the existence of an inducement and, consequently, of a restriction of competition by object (see paragraphs 265 to 273 above).

798

It should be explained in that respect that a side deal is a normal commercial agreement linked to a settlement agreement which contains clauses which are by themselves restrictive (see paragraph 257 above). Such a link exists, in particular, where the two agreements are concluded on the same day, where they are legally linked, the binding nature of one of the agreements being conditional upon the conclusion of the other agreement, or where, in the light of the context in which they are concluded, the Commission is able to establish that they are indissociable. It may be added that, the shorter the time between the conclusion of each agreement, the easier it will be for the Commission to establish that indissociable nature.

799

It should also be noted that the fact that the settlement agreement and the side deal are concluded on the same day or that there is a contractual link between them is an indication that those agreements form part of a single contractual framework. If those agreements were not concluded on the same day (and if there were no contractual link between them), one of the parties to the negotiation would grant the other party everything it wants without any certainty of ultimately obtaining the expected quid pro quo. That temporal or legal link between the two agreements is also an indication that they were negotiated together.

800

The side deal is a normal commercial agreement that could exist independently without the settlement of a dispute being at issue. Likewise, the conclusion of a settlement agreement does not require the concurrent conclusion of a commercial agreement. Thus, the two agreements do not need to be linked. Moreover, that linkage cannot be justified by the settlement of a dispute, because the purpose of the side deal is not to reach such a settlement but rather to carry out a commercial transaction.

801

In addition, a side deal involves value transfers, of a financial or non-financial nature, between the parties. It may involve, in particular, the transfer of value from the patent holder to the generic company.

802

There is therefore a risk that the linking of a commercial agreement with a settlement agreement containing non-marketing and non-challenge clauses, which are, by themselves, restrictive of competition (see paragraph 257 above), is actually intended — under the guise of a commercial transaction, taking the form, as the case may be, of a complex contractual arrangement — to induce the generic company to accept those clauses, through a value transfer provided for in the side deal.

803

Consequently, the fact that a commercial agreement, which does not normally have the settlement of a dispute as its subject matter (see paragraph 800 above), and which serves as a vehicle for a transfer of value from the originator company to the generic company, is, in the circumstances set out in paragraph 798 above, linked with a settlement agreement containing competition-restricting clauses is a strong indication of the existence of a reverse payment (see paragraph 264 above).

804

However, the strong indication referred to in the preceding paragraph is not sufficient and the Commission must therefore support it with other consistent evidence justifying the conclusion that there is a reverse payment. Such a payment, in the specific context of side deals, corresponds to the part of the payment made by the originator company which exceeds the ‘normal’ value of the asset traded (or, as the case may be, to the part of the ‘normal’ value of the asset traded which exceeds the payment made by the generic company).

805

It should be noted, in that respect, that the Commission, relying on various indicia, including the fact that Lupin gave no guarantee that a patent would be granted, that it would be valid or that the products or processes claimed would be non-infringing (Clause 2.2(a) of the Lupin agreement), stated twice in the contested decision that the acquisition of Lupin’s technology had not been negotiated ‘at arm’s length’ (recitals 1950 and 1952).

806

It should be noted that the concept of ‘normal competitive conditions’, which is similar to that of ‘arm’s length’, even though it is not used in relation to agreements, decisions and concerted practices, is not alien to competition law, since it is used in the particular field of State aid in order to determine whether a State has acted like a private investor (judgment of 2 September 2010, Commission v Scott, C‑290/07 P, EU:C:2010:480, paragraph 68), that is to say, whether the advantage granted to the undertakings in question constitutes the normal remuneration for a quid pro quo obtained by the State. That concept may therefore constitute, by analogy, a relevant reference parameter when determining whether two companies that concluded a commercial transaction did so on the basis of economic considerations limited to the economic value of the asset traded, for example to its prospects of profitability, and, thus, at arm’s length.

807

Where there are indicia or evidence put forward by the Commission in order to support a finding that the side deal was not concluded at arm’s length, the parties to the agreements may present their version of the facts, supporting their claims with the evidence that they are able to provide and which permits the conclusion that the commercial agreement, although linked to the settlement agreement, is justified by reasons other than the exclusion of a competitor by means of a reverse payment. The parties to the agreements may thus argue that the side deal was concluded at arm’s length by adducing relevant evidence concerning, for example, the industrial and commercial practices in the sector or the particular circumstances of the case.

808

In the light of all the evidence available to it and, as the case may be, the lack of an explanation or the lack of a plausible explanation from the parties to the agreements, the Commission may be justified in finding, following an overall assessment, that the side deal was not concluded at arm’s length, that is to say that the payment made by the originator company exceeds the value of the asset traded (or that the value of the asset transferred to the generic company exceeds the payment made by the latter). The Commission may thus conclude that there is a reverse payment (see paragraph 804 above).

809

A reverse payment, if it is not intended to compensate for costs inherent in the settlement, therefore constitutes an inducive benefit (see paragraphs 265 and 278 to 280 above). That is the case where the purpose of a side deal is not to settle a dispute but rather to carry out a commercial transaction (see paragraph 800 above).

810

However, the parties to the agreement may still argue that the benefit in question is insignificant, if the amount of that benefit is insufficient to be regarded as a significant inducement to accept the competition-restricting clauses set out in the settlement agreement (see paragraph 280 above).

811

The specific circumstances of the present case must be examined in the light of the foregoing considerations.

812

It should be noted that Servier and Lupin concluded, on the same day, a settlement agreement containing non-marketing and non-challenge clauses and a technology assignment agreement by which Servier purchased from Lupin three patent applications filed by the latter. Moreover, those two agreements were concluded in the form of a single agreement. The link between the two agreements is therefore clear.

813

In addition, the assignment agreement served as a vehicle for a transfer of value from Servier to Lupin.

814

It follows from paragraphs 812 and 813 above that the assignment agreement constituted a side deal which served as a vehicle for a transfer of value from the originator company to the generic company. It is a strong indication that the transfer of value in question is not merely the quid pro quo for the asset transferred under the side deal, but also involves a reverse payment (within the meaning of that expression in relation to side deals).

815

Moreover, it is common ground that Servier paid Lupin EUR 40 million under the assignment agreement, which is a significant amount in absolute terms, as the Commission correctly noted in recitals 1871 and 1947 of the contested decision.

816

That amount exceeded the profits that Lupin could expect from its independent market entry during the first two to three years of marketing, as the Commission rightly found in recital 1974 of the contested decision.

817

It is also common ground that the amount in question was greater than the investments made by another comparable generic company, for the purposes of developing its own perindopril, as highlighted by the Commission in recital 1962 of the contested decision. That piece of evidence, relied on by the Commission, is particularly relevant, contrary to the applicants’ submissions.

818

It should be added that Lupin did not transfer patents, but mere patent applications. In addition, it was expressly stipulated in the Lupin agreement that Lupin gave no assurance that a patent would be granted, that it would be valid or that any product or process claimed would be non-infringing (Clause 2.2(a) of the Lupin agreement).

819

Lastly, it is common ground that although, in their replies to the statement of objections, Servier and Lupin both denied that the settlement depended on the terms of the assignment of the patent applications, Lupin had previously stated that the assignment of those applications was an integral part of the discussions concerning the settlement of the dispute. It had also described the payments received as ‘settlement monies’ or ‘settlement sums’ (recital 1937 of the contested decision).

820

However, the applicants have not adduced any specific evidence to show that the acquisition of Lupin’s patent applications for EUR 40 million could reasonably be regarded as a profitable investment (see, to continue the analogy with the concept of a ‘private investor in a market economy’ begun in paragraph 806 above, paragraph 84 of the judgment of 12 December 2000, Alitalia v Commission, T‑296/97, EU:T:2000:289, in which it is stated that the conduct of a private investor in a market economy is guided by prospects of profitability) or, at the very least, as being such as to generate, for the acquirer of those applications, income capable of compensating for the high cost of acquiring them.

821

Admittedly, the applicants refer, albeit in scant detail, to the existence of transactions which, in their view, are comparable to the assignment agreement concluded with Lupin. Those transactions were, however, agreements to which the applicants were parties and may therefore only on an ancillary basis serve as a reference for the purpose of establishing that a transaction was carried out at arm’s length. Moreover, some of those transactions have been classified as an infringement of competition law by the Commission. Lastly, the applicants do not establish that the technology transferred in the context of those various transactions was equivalent to that at issue in the assignment agreement.

822

It is true that the applicants also refer, in that regard, to the opinion of a person who describes himself as an intellectual property consultant. However, that person himself states that he drew up his opinion on behalf of Servier. This necessarily limits the probative value of such an opinion. Most importantly, the conclusion of that opinion (‘I therefore consider that the purchases are within the limits of a company’s normal practice’) and the evidence upon which that conclusion is based are too general to establish that the transfer of value in question corresponded to a transaction carried out at arm’s length. Moreover, the transactions serving as a reference are again transactions in which Servier was involved and which, in some cases at least, have been regarded by the Commission as infringements of competition law.

823

Furthermore, even if it were established, as the applicants maintain, that Servier’s patent and production or other departments regarded Lupin’s technology as ‘interesting’, that fact would nevertheless not support a finding that the transfer of value in question corresponded to a transaction carried out at arm’s length.

824

Likewise, even assuming that ‘the price was negotiated from the initial claims until a level acceptable to both parties was reached’, this nevertheless would not support a finding that the value transfer at issue corresponded to a transaction carried out at arm’s length.

825

Thus, the evidence produced by the applicants does not justify, even taken into account cumulatively, the conclusion that the value transfer at issue corresponded to a transaction carried out at arm’s length.

826

In that respect, it should be noted that the Commission, relying, inter alia, on the case-law cited in paragraph 795 above (recital 1940 of the contested decision), considered that ‘neither Servier nor Lupin were able to provide a plausible description of the factors determining how the final sum of EUR 40 million [had been] reached’ (recital 1955 of the contested decision). The Commission also stated, in recital 1944 of the contested decision, that it was entitled to draw inferences from ‘a situation where potential exculpatory evidence [could] only come from the parties themselves’, and that ‘the parties [were] unable to produce such evidence despite several requests [for] information’. It added, in recital 1964 of the contested decision, that ‘Servier [had been] unable to produce any contemporaneous documents that would be informative as to the amount of savings expected from acquiring Lupin’s technology’. Lastly, it concluded, having regard, inter alia, to ‘the absence of evidence’ of Servier’s commercial interest in the technology transferred by Lupin, that the transfer of value under the assignment agreement represented a significant inducement (recital 1978 of the decision).

827

In view of all of the evidence discussed before the Court, it must be concluded that the Commission established the existence of a reverse payment which was not inherent in the settlement agreement at issue (see paragraph 809 above) and was therefore an inducement.

828

Lastly, it must be noted, in view of the considerations set out in paragraphs 815 to 827 above, that it has not been established that the benefit in question is insignificant, that is to say, of an amount insufficient to be regarded as a significant inducement to accept the anticompetitive clauses contained in the settlement agreement (see paragraph 810 above).

(ii) The absence of a limitation of the generic company’s efforts to compete with the originator company

829

In the present case, the Lupin agreement contains non-marketing and non-challenge clauses, which, as noted in paragraph 257 above, are, by themselves, restrictive of competition.

830

The applicants submit however that the non-marketing and non-challenge clauses in the Lupin agreement are in no way restrictive of competition, in view of the manner in which other clauses in the agreement limit that restrictiveness. It is necessary to examine the validity of that assertion.

831

As a preliminary point, it must be noted that the products covered by the Lupin agreement are defined in recital A of that agreement, which refers to ‘pharmaceutical products containing, as an active ingredient, perindopril tert-butylamine (also known as perindopril erbumine) and any salt thereof (“the Products”)’.

832

Even though recital A of the Lupin agreement refers to ongoing litigation which, at the European level, only concerns the 947 patent, as is apparent from recitals B and D of that agreement, that clause, in view of its wording, does not appear to refer only to products containing perindopril erbumine in its alpha form, that is to say those covered by the 947 patent, but rather all products containing erbumine, regardless of its form.

833

In addition, the expression ‘any salt thereof’ is ambiguous. On the one hand, from a grammatical perspective, the term ‘thereof’ refers more obviously to perindopril tert-butylamine, that is to say erbumine, than to perindopril in its entirety, since the latter is not mentioned, as such, in that part of the sentence. On the other hand, it is not disputed that erbumine is a salt, with the result that the term ‘thereof’ should not refer to erbumine, but, more generally, to perindopril in its entirety.

834

Consequently, it is difficult to determine, in view of the wording of the clauses of the agreement, whether the products covered by that agreement are limited to the alpha form of erbumine or also include other forms of erbumine, or even other salts of perindopril.

835

In that context of uncertainty, it must be verified whether the scope of the non-marketing and non-challenge clauses was limited to the extent that these clauses were no longer restrictive.

836

In the first place, the restrictive nature of the non-challenge clause is clear, since Clause 1.3 of the Lupin agreement stipulates that:

‘Following the date of this Agreement Lupin shall not directly or indirectly seek or assist or procure any third party to revoke, invalidate or otherwise challenge the Patents or any patent owned by Servier or its affiliates covering the Products in any country other than [a specific non-EEA Member State].’

837

In addition, it is apparent from the separate terms ‘the Patents’ and the ‘Servier Patents’, defined respectively in recital D and Clause 1.3 of the Lupin agreement, that that provision applies not only to the patents referred to in recitals B, C and D (including the 947 patent), which were the subject of litigation between Lupin and Servier, but also, at least potentially, to a series of patents which were not identified by name and which protect the products covered by the agreement.

838

In the second place, as regards the scope of the non-marketing clause, Clause 1.6 of the Lupin agreement prohibits Lupin from marketing the products referred to in the agreement.

839

It is apparent, however, from the terms of Clause 1.6 of the Lupin agreement that, where the circumstances set out in Clause 4.1 of that agreement apply, Lupin may sell or offer for sale products supplied by Servier or its own products. Clause 4.1 sets out the circumstances in which Servier is required to sell its products to Lupin. Three scenarios are envisaged in that provision.

840

In the first scenario, Lupin may enter one of the national markets covered by the agreement if some of Servier’s products are marketed by a third party in that market. In the second scenario, Lupin may enter such a market if Servier’s patent application is rejected or if its patent expires, is declared invalid or is revoked. Lastly, in the third scenario, Lupin may enter such a market if a generic product not produced by Servier is sold on that market — unless Servier has applied for an injunction and that application has not been rejected — and the generic medicinal product is not being sold in breach of an injunction applying in that market.

841

Thus, in essence, the market entry of Lupin, including with its own products (see paragraph 839 above), is possible in two cases.

842

First, Lupin may enter the market if Servier authorises the sale of its products by a third party, decides not to submit a patent application or decides not to apply for an injunction, that is to say in circumstances that depend on a discretion on the part of Servier over which Lupin has no influence. In this first case, the application of the circumstances set out in Clause 4.1 of the Lupin agreement cannot be regarded as calling into question, by itself, the restrictive nature of the non-marketing clause (see paragraph 257 above) or, a fortiori, as facilitating Lupin’s market entry.

843

Secondly, Lupin may enter the market if Servier’s patents do not allow it to oppose that entry. In that case, Clause 4.1 of the Lupin agreement does not allow Lupin to make an early market entry in relation to the effects of a patent that is still valid or enforceable. It merely reflects the absence of a valid or enforceable patent, thus avoiding a situation in which the non-marketing clause would be devoid of any link with such a patent and would then clearly show a sufficient degree of harm to the proper functioning of normal competition for it to be classified as a restriction by object (see paragraph 877 below). In this second case, the application of the circumstances set out in Clause 4.1 cannot therefore be regarded as calling into question, by itself, the restrictive nature of the non-marketing clause (see paragraph 257 above) and, a fortiori, as facilitating Lupin’s market entry.

844

The non-marketing clause must therefore be held to be restrictive, despite the provisions of Clause 4.1 of the Lupin agreement.

845

The above conclusion is not called in question by the other arguments put forward by the applicants.

846

First, the applicants submit that the agreement allowed Lupin to enter the market early, that is to say before the date on which the validity of the 947 patent was expected to come to an end. According to the applicant, such early entry reduces or even neutralises the competition-restricting nature of a non-marketing clause.

847

It should be noted that, even though that interpretation is not evident due to the complex wording of Clause 1.6 of the Lupin agreement, it could be accepted that that clause, read in conjunction with Clause 4.1(c) of the same agreement, allows the market entry of Lupin with its own products where a generic ‘Product’ which is not produced by Servier has entered the market without breaching an injunction (and, moreover, where an application for an injunction lodged by Servier is not currently under examination).

848

Since the term ‘Product’, as set out in Clause 4.1(c) of the Lupin agreement, begins with an upper-case letter, it must be understood within the meaning of the definition given in recital A of that agreement, where that term is defined with an upper-case first letter (see paragraph 831 above).

849

In the light of recital A of the Lupin agreement, which seems to refer to products containing erbumine, regardless of its form (see paragraph 832 above), Clause 4.1(c) of that agreement could be interpreted, where it refers to products which are not sold in breach of an injunction, as referring to products containing forms of erbumine other than the alpha form. Thus, the agreement could be interpreted as authorising Lupin to enter the market after a third party has entered the market with generic perindopril containing a non-alpha form of erbumine.

850

In addition, the ambiguous wording of recital A of the Lupin agreement also creates uncertainty as to whether Clause 4.1(c) of that agreement could be interpreted, where it refers to products which are not sold in breach of an injunction, as also referring to products not containing erbumine (see paragraph 833 above). That could then lead to the conclusion that the agreement authorised Lupin to enter the market after a third party has entered the market with any generic perindopril in the form of a salt, including a salt other than erbumine.

851

It may therefore be concluded that the agreement provided for the market entry of Lupin, with its own products, before the expected end date of the validity of the 947 patent, since any marketing by a third party of products which do not contain the alpha form of erbumine — because it could not breach an injunction protecting that patent — would in turn allow Lupin to enter the market with its own products.

852

However, because of the uncertainties surrounding the scope of Clauses 1.6 and 4.1 of the Lupin agreement, set out in paragraphs 846 to 850 above, Lupin could fear that the non-marketing clause would continue to apply after a third party had entered the market with generic perindopril composed of a non-alpha form of erbumine or generic perindopril not composed of erbumine. That doubt was such as to deter it from entering the market. There was additional uncertainty due to the fact that, even if the term ‘Product’ were interpreted broadly (as covering any salt of perindopril), Servier could nevertheless apply for an injunction, even in respect of a product which clearly did not infringe any of its patents, in particular the 947 patent, which would effectively prevent the application of Clause 4.1(c) of the Lupin agreement until that application was rejected.

853

In that regard, it may also be noted that, as regards the French market, the parties exchanged several letters concerning whether Sandoz’s entry to the market allowed Lupin to enter the market in turn. In a letter of 17 March 2009, Lupin thus asked Servier whether it was opposed to Lupin’s entry to the French market. By a letter of 31 March 2009, Servier merely stated that Sandoz’s product did not infringe any of its patents. As a result of that response, Lupin felt compelled to request, by letter of 3 April 2009, clarifications from Servier. It wrote, inter alia, the following:

‘Lupin does not think that Servier has any valid reason to oppose the sale by Lupin of its perindopril erbumine product in France to its local partner(s) or the resale of that product by that/those French partner(s). Your letter of 31 March 2009 does not clearly indicate whether Servier disagrees with any of those points. If Servier disagrees, please provide a full explanation of Servier’s position by 9 April 2009 by close of business.’

854

Accordingly, the very existence of Lupin’s letters and the content of the last of them reveal its uncertainties as to its ability to enter the French market without infringing the agreement.

855

Consequently, the non-marketing clause must be found to be restrictive irrespective of the interpretation given to recital A of the Lupin agreement, especially since the uncertainties arising from the complexity of an agreement or the ambiguity of its wording must not allow the parties to avoid liability as regards competition law.

856

Even if the interpretation of the agreement presented in paragraph 851 were accepted, the hypothetical nature of the events mentioned at the end of paragraphs 849 and 850 above — that is to say the marketing of a generic product by a third party — precludes the conclusion that the restrictive nature of the non-marketing clause is neutralised and that therefore there is no infringement in that respect. It is necessary to distinguish between, on the one hand, the issue of the very existence of the infringement, which cannot be called into question by the mere possibility that future events may occur, and, on the other hand, that of the duration of the infringement, which may depend on the actual occurrence of such events.

857

In addition, the early entry of Lupin depends, in any event, on the marketing of a generic product by a third party, that is to say a circumstance which is both unconnected with the parties to the agreement and uncertain. That entry is therefore not the result of a clear choice of those parties on which they could rely in order to establish that the agreement between them — and, in particular, the non-marketing clause in that agreement — is not restrictive of competition.

858

Secondly, it is true that the Lupin agreement provides in Clause 4.2 for the future conclusion of a supply agreement between the parties. However, the implementation of such an agreement depends on the occurrence of one of the circumstances envisaged in Clause 4.1 of the Lupin agreement. Since, as has just been indicated, the implementation of that latter clause does not justify the conclusion that the non-marketing clause is not restrictive, the same is true of the supply agreement mentioned in Clause 4.2.

859

In addition, it may be observed that no supply agreement has been concluded between the parties. Furthermore, the Lupin agreement did not provide that failure to adopt a supply agreement would have significant legal consequences for the parties, such as, for example, termination of the Lupin agreement as a whole or of the non-marketing and non-challenge clauses in it. Thus, even if a supply agreement could be regarded as being likely to facilitate the market entry of a generic company that would be a potential competitor of the originator company, in the present case, the Lupin agreement, which merely provided for a supply agreement in principle, without providing for measures or sanctions to ensure the implementation of that agreement, could not be regarded as facilitating Lupin’s market entry.

860

Admittedly, it is clear from Clause 4.2 of the Lupin agreement that the supply agreement was supposed to enable the application of Clause 4.1 of the Lupin agreement, which stipulated an ‘irrevocable’ commitment on Servier’s part to supply the ‘Products’, within the meaning of the agreement, to Lupin. However, the binding nature of Servier’s commitment must be put in perspective in the light of the considerations set out in paragraph 859 above.

861

Thirdly, although the applicants maintain that an interpretation of Clause 1.3 of the Lupin agreement as meaning that the non-challenge clause applies beyond the 947 patent alone must lead to the conclusion, under Clause 1.7 of that agreement, that Lupin had a free licence over all those patents, that claim is erroneous in the light of the terms of Clause 1.7, as translated into the language of the case by the applicants and according to which:

‘In order to avoid any confusion, this agreement does not grant Lupin any right or licence, in any jurisdiction, over the Servier Patents, it being understood that neither Servier nor its subsidiaries, licensees and/or assignees of the Servier Patents will exercise their rights over the Servier Patents in connection with Lupin’s exercise of its right to sell the Products manufactured by Lupin/Lupin (Europe) Limited granted under Clause 1.6.’

862

Indeed, the wording of that stipulation is unclear because of an at least apparent contradiction between the first part of the sentence (this agreement does not grant Lupin any right or licence, in any jurisdiction, over the Servier Patents) and the part which follows (it being understood that neither Servier nor its subsidiaries, licensees and/or assignees of the Servier Patents will exercise their rights over the Servier Patents in connection with Lupin’s exercise of its right to sell the Products manufactured by Lupin/Lupin (Europe) Limited granted under Clause 1.6). Moreover, the necessity of the first part of the sentence is not clear, since no stipulation in the agreement suggests that Lupin had a licence for rights other than those relating to the technology which it had assigned to Servier. Furthermore, any understanding of the clause is further complicated by the reference in it to Clause 1.6 of the Lupin agreement, itself referring to Clause 4.1 of that agreement, which lays down the conditions under which Lupin may enter the market with its own product. Thus, in the light of its wording, Clause 1.7 was likely to give rise to uncertainty which would deter Lupin from entering the market.

863

Above all, the non-use by Servier of its patent rights against Lupin depends on fulfilment of one of the conditions laid down in Clause 4.1 of the Lupin agreement (to which Clause 1.6 of that agreement refers). To the extent that, as stated in paragraphs 844 and 855 above, the implementation of Clause 4.1 does not support the conclusion that the non-marketing clause is not restrictive, the same applies to the implementation of Clause 1.7 of that agreement, including where the term ‘Servier Patents’ is understood broadly so as to include patents relating not only to the alpha form of erbumine, but also to other forms of erbumine or even to other perindopril salts.

864

It follows from the foregoing that the Commission was entitled to conclude that there was a limitation of Lupin’s efforts to compete with Servier.

(iii) The absence of infringement

865

In view of the considerations set out in paragraphs 789 to 864 above, it may be observed that the Commission rightly found both an inducive benefit and a corresponding limitation of Lupin’s efforts to compete with Servier.

866

As noted in paragraph 272 above, in the context of patent dispute settlement agreements, a finding of a restriction of competition by object presupposes that the settlement agreement contains both an inducive benefit to the generic company and a corresponding limitation of the generic company’s efforts to compete with the originator company. Where these two conditions are met, it must be found that there has been an inducement.