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Document 62019CJ0151
Judgment of the Court (First Chamber) of 27 June 2024.#European Commission v KRKA, tovarna zdravil, d.d.#Appeal – Competition – Pharmaceutical products – Market for perindopril – Article 101 TFEU – Agreements, decisions and concerted practices – Market sharing – Potential competition – Restriction of competition by object – Strategy to delay the market entry of generic versions of perindopril – Patent dispute settlement agreement – Patent licence agreement – Technology assignment and licence agreement.#Case C-151/19 P.
Judgment of the Court (First Chamber) of 27 June 2024.
European Commission v KRKA, tovarna zdravil, d.d.
Appeal – Competition – Pharmaceutical products – Market for perindopril – Article 101 TFEU – Agreements, decisions and concerted practices – Market sharing – Potential competition – Restriction of competition by object – Strategy to delay the market entry of generic versions of perindopril – Patent dispute settlement agreement – Patent licence agreement – Technology assignment and licence agreement.
Case C-151/19 P.
Judgment of the Court (First Chamber) of 27 June 2024.
European Commission v KRKA, tovarna zdravil, d.d.
Appeal – Competition – Pharmaceutical products – Market for perindopril – Article 101 TFEU – Agreements, decisions and concerted practices – Market sharing – Potential competition – Restriction of competition by object – Strategy to delay the market entry of generic versions of perindopril – Patent dispute settlement agreement – Patent licence agreement – Technology assignment and licence agreement.
Case C-151/19 P.
ECLI identifier: ECLI:EU:C:2024:546
JUDGMENT OF THE COURT (First Chamber)
27 June 2024 (*)
(Appeal – Competition – Pharmaceutical products – Market for perindopril – Article 101 TFEU – Agreements, decisions and concerted practices – Market sharing – Potential competition – Restriction of competition by object – Strategy to delay the market entry of generic versions of perindopril – Patent dispute settlement agreement – Patent licence agreement – Technology assignment and licence agreement)
In Case C‑151/19 P,
APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 22 February 2019,
European Commission, represented initially by F. Castilla Contreras, B. Mongin and C. Vollrath, acting as Agents, and by D. Bailey, Barrister, and subsequently by F. Castilla Contreras and C. Vollrath, acting as Agents, and by D. Bailey, Barrister,
appellant,
supported by:
United Kingdom of Great Britain and Northern Ireland, represented initially by D. Guðmundsdóttir, acting as Agent, subsequently by L. Baxter, D. Guðmundsdóttir, F. Shibli and J. Simpson, acting as Agents, and by J. Holmes KC, and P. Woolfe, Barrister, and lastly by S. Fuller, acting as Agent, and by J. Holmes KC, and P. Woolfe, Barrister,
intervener in the appeal,
the other party to the proceedings being:
KRKA, tovarna zdravil, d.d., established in Novo mesto (Slovenia), represented by T. Ilešič and M. Kocmut, odvetnika,
applicant at first instance,
THE COURT (First Chamber),
composed of A. Arabadjiev (Rapporteur), President of the Chamber, K. Lenaerts, President of the Court, acting as Judge of the First Chamber, P.G. Xuereb, A. Kumin and I. Ziemele, Judges,
Advocate General: J. Kokott,
Registrar: M. Longar and R. Şereş, Administrators,
having regard to the written procedure and further to the hearing on 20 and 21 October 2021,
having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,
gives the following
Judgment
1 By its appeal, the European Commission seeks to have set aside the judgment of the General Court of the European Union of 12 December 2018, Krka v Commission (T‑684/14, ‘the judgment under appeal’, EU:T:2018:918), by which the General Court annulled Article 4, in so far as it found that KRKA, tovarna zdravil, d.d. (‘Krka’) had participated in the agreements referred to in that article, Article 7(4)(a), and, in so far as they concern Krka, Articles 8 and 9 of European 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)) (‘the decision at issue’).
I. Background to the dispute
2 The background to the dispute, as described in particular in paragraphs 1 to 37 of the judgment under appeal, may be summarised as follows.
3 Servier SAS is the parent company of the Servier pharmaceutical group which includes Les Laboratoires Servier SAS and Servier Laboratories Ltd (individually or jointly, ‘Servier’). Les Laboratoires Servier is specialised in the development of originator medicines, while its subsidiary Biogaran SAS is specialised in the development of generic medicines.
A. Servier’s perindopril
4 Servier developed perindopril, a medicinal product primarily intended for the treatment of hypertension and heart failure. That medicinal product is one of the angiotensin converting enzyme inhibitors. The angiotensin converting enzyme inhibitors which existed at the material time were classified both at the third level of the Anatomical Therapeutic Chemical (ATC) classification of the World Health Organisation (WHO), which corresponds to therapeutic indications, and at the fourth level of that classification, corresponding to the mode of action, in the same group, entitled ‘[angiotensin converting enzyme] inhibitors, plain’. The active ingredient of perindopril takes the form of a salt. The salt used initially was erbumine.
5 Patent EP0049658, relating to the active ingredient of perindopril, was filed with the European Patent Office (EPO) on 29 September 1981 by a company in the Servier group. That patent was due to expire on 29 September 2001, but its protection was prolonged in a number of Member States, including the United Kingdom, until 22 June 2003. In France, protection under the patent was prolonged until 22 March 2005 and, in Italy, until 13 February 2009.
6 On 16 September 1988, Servier filed a number of patents with the EPO relating to processes for the manufacture of the active ingredient of perindopril, with an expiry date of 16 September 2008, that is to say, patents EP0308339, EP0308340 (‘the 340 patent’), EP0308341 and EP0309324.
7 On 6 July 2001, Servier filed patent EP1296947 (‘the 947 patent’), with the EPO, relating to the alpha crystalline form of perindopril erbumine and the process for its manufacture, which was granted by the EPO on 4 February 2004.
8 On 6 July 2001, Servier also filed national patent applications in several 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. Servier filed, for example, patent applications relating to the 947 patent in Bulgaria (BG 107 532), the Czech Republic (PV 2003-357), Estonia (P200300001), Hungary (HU225340), Poland (P348492) and Slovakia (PP0149-2003). Those 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.
B. Krka’s perindopril
9 From 2003, Krka, a company established in Slovenia which manufactures generic medicines, started to develop medicinal products based on the active ingredient perindopril, composed of the alpha crystalline form of erbumine covered by the 947 patent (‘Krka’s perindopril’). In 2005 and 2006, it obtained a number of marketing authorisations and began marketing the medicinal product in question in several Member States in central and eastern Europe, including Hungary and Poland. During that period, it also made preparations to place the medicinal product on the market in other Member States, including France, the Netherlands and the United Kingdom.
C. Disputes relating to perindopril
10 Between 2003 and 2009, a number of disputes were conducted between Servier and manufacturers preparing to market a generic version of perindopril.
1. The EPO decisions
11 In 2004, 10 manufacturers of generic medicines, including Niche Generics Ltd (‘Niche’), Krka, Lupin Ltd and Norton Healthcare Ltd, a subsidiary of Ivax Europe, which subsequently merged with Teva Pharmaceutical Industries Ltd, the ultimate parent company in the Teva group, specialising in the manufacture of generic medicines, filed opposition proceedings against the 947 patent before the EPO, seeking its revocation on grounds of lack of novelty, lack of inventive step and insufficient disclosure of the invention.
12 On 27 July 2006, the EPO Opposition Division confirmed the validity of the 947 patent (‘the EPO decision of 27 July 2006’). That decision was challenged before the EPO Technical Board of Appeal. After concluding a settlement agreement with Servier, Niche withdrew from the opposition proceedings on 9 February 2005. Krka and Lupin withdrew the proceedings before the EPO Technical Board of Appeal on 11 January 2007 and 5 February 2007, respectively.
13 By decision of 6 May 2009, the EPO 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 of the Technical Board of Appeal was rejected on 19 March 2010.
2. The decisions of the national courts
14 The validity of the 947 patent has been challenged before certain national courts by manufacturers of generic medicines, and Servier has brought actions for infringement and has applied for interim injunctions against those manufacturers. The majority of those proceedings were closed before the courts seised were able to give a final ruling on the validity of the 947 patent, as a result of settlement agreements concluded by Servier, between 2005 and 2007, with Niche, Matrix, Teva, Krka and Lupin.
15 In the United Kingdom, only the dispute between Servier and Apotex Inc. gave rise to a finding, by a court, that the 947 patent was invalid. On 1 August 2006, Servier brought an action for infringement of the 947 patent before the High Court of Justice (England & Wales), Chancery Division (patents court) (United Kingdom), against Apotex, which had begun marketing a generic version of perindopril on the UK market. On 8 August 2006, Servier was granted an interim injunction against Apotex. On 6 July 2007, following a counterclaim by Apotex, that interim injunction was lifted and the 947 patent was declared invalid, thereby enabling Apotex to place a generic version of perindopril on the market in the United Kingdom. On 9 May 2008, the decision declaring the 947 patent invalid was confirmed on appeal.
16 In the Netherlands, on 13 November 2007, Katwijk Farma BV, an Apotex subsidiary, brought an action before a court of that Member State seeking a declaration of invalidity of the 947 patent. Servier applied to that court for an interim injunction, which was refused on 30 January 2008. By decision of 11 June 2008 in proceedings brought by Pharmachemie BV, a company in the Teva group, that court declared the 947 patent invalid for the Netherlands. Following that decision, Servier and Katwijk Farma withdrew their claims.
17 A number of disputes between Servier and Krka relating to perindopril were also brought before national courts.
18 In Hungary, on 30 May 2006, Servier applied for an interim injunction preventing the marketing of Krka’s perindopril, as a result of the infringement of the 947 patent. That application was rejected in September 2006.
19 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, Servier brought an action for infringement of the 947 patent and an application for an interim injunction against Krka before that court. On 1 September 2006, Krka brought an initial counterclaim seeking the invalidation of the 947 patent, with an attached motion for summary judgment, and on 8 September 2006, a second counterclaim seeking the invalidation of the 340 patent. On 3 October 2006, that court granted Servier’s application for an interim injunction and dismissed the motion for summary judgment lodged by Krka on 1 September 2006 (‘the decision of the High Court of 3 October 2006’). On 1 December 2006, the proceedings were discontinued as a result of the settlement reached between the parties and that interim injunction was lifted.
D. The Krka agreements
20 Servier and Krka concluded three agreements (‘the Krka agreements’). On 27 October 2006, they concluded a settlement agreement (‘the Krka settlement agreement’) and a licence agreement, which was supplemented by an amendment on 2 November 2006 (‘the Krka licence agreement’ and, both those agreements together, ‘the Krka settlement and licence agreements’). In addition, on 5 January 2007, Servier and Krka concluded an assignment and licence agreement (‘the Krka assignment and licence agreement’).
21 The Krka settlement agreement covered the 947 patent and the equivalent national patents. By that agreement, in force until the expiry or the revocation of the 947 or the 340 patent, Krka undertook to withdraw any claim against the 947 patent worldwide and against the 340 patent in the United Kingdom, and not to challenge either of those two patents worldwide in the future. Moreover, Krka and its subsidiaries were not authorised to launch or to market a generic version of perindopril which would infringe the 947 patent for the duration of the validity of that patent and in the countries in which it was still valid, unless expressly authorised by Servier. Similarly, Krka could not supply to any third party a generic version of perindopril that would infringe the 947 patent, unless expressly authorised by Servier. In return, Servier was required to withdraw its actions against Krka for infringement of the 947 and 340 patents, including its pending applications for interim injunctions, worldwide.
22 Pursuant to the Krka licence agreement, the duration of which corresponded to the validity of the 947 patent, Servier granted Krka an exclusive, irrevocable licence on that patent to use, manufacture, sell, offer for sale, promote and import its own products which contain the alpha crystalline form of erbumine in the Czech Republic, Latvia, Lithuania, Hungary, Poland, Slovenia and Slovakia (‘Krka’s core markets’). In return, Krka was required, under Article 3 of that agreement, to pay Servier 3% royalties on its net sales throughout those territories. 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.
23 Pursuant to the Krka assignment and licence agreement, Krka assigned two patent applications to Servier, one concerning a process for the synthesis of perindopril (WO 2005 113500) and the other the preparation of formulations of perindopril (WO 2005 094793). The technology protected in those patent applications was used for the production of Krka’s perindopril. Krka undertook not to challenge the validity of any patents granted on the basis of those applications. In return for that assignment, Servier paid Krka the sum of EUR 30 million.
24 In addition, by that agreement, Servier also granted Krka a non-exclusive, irrevocable, non-assignable, royalty-free licence, with no right to sublicense (other than to its subsidiaries) on the applications or resulting patents, that licence being unrestricted in time, territory or scope of use.
II. The decision at issue
25 On 9 July 2014, the Commission adopted the decision at issue.
26 In Article 4 of that decision, the Commission found that Krka had infringed Article 101 TFEU by participating in the Krka agreements. In particular, the Commission stated that those agreements had constituted a single and continuous infringement covering all the Member States of the European Union at the material time, with the exception of those constituting Krka’s core markets; that the infringement had started on 27 October 2006, except in relation to Bulgaria and Romania, where it had started on 1 January 2007, Malta, where it had started on 1 March 2007, and Italy, where it had started on 13 February 2009; and that that infringement had ended on 6 May 2009, except in the case of the United Kingdom, where it ended on 6 July 2007, and the Netherlands, where it ended on 12 December 2007.
27 In Article 7(4)(a) of the decision at issue, the Commission imposed on Krka a fine of EUR 10 million. In Article 8 of that decision, the Commission ordered the undertakings referred to in Articles 1 to 6 of that decision, including Krka, to refrain from repeating the infringement penalised and from any act or conduct having the same or similar object or effect. In Article 9 of that decision, the Commission referred to Krka as one of the persons to whom that decision was addressed.
III. The procedure before the General Court and the judgment under appeal
28 By document lodged at the Registry of the General Court on 19 September 2014, Krka brought an action for annulment of the decision at issue.
29 In its action at first instance, Krka raised six pleas in law in support of its claim for annulment of the decision at issue. The General Court upheld the third and fourth pleas in law, by which Krka disputed the characterisation of the Krka agreements as a restriction of competition by object within the meaning of Article 101(1) TFEU, and the fifth plea in law, by which it disputed the characterisation of those agreements as a restriction of competition by effect within the meaning of Article 101(1) TFEU. Consequently, the General Court annulled Article 4 of that decision in so far as it found that Krka had participated in the agreements referred to in that article; Article 7(4)(a), which imposed a fine on Krka; and Articles 8 and 9 in so far as they concerned Krka.
IV. Procedure before the Court of Justice and forms of order sought
30 By document lodged at the Registry of the Court of Justice on 22 February 2019, the Commission brought the present appeal.
31 By document lodged at the Registry of the Court on 5 June 2019, the United Kingdom of Great Britain and Northern Ireland sought leave to intervene in the present case in support of the form of order sought by the Commission. By decision of 8 July 2019, the President of the Court of Justice granted that application.
32 The Court invited the parties to submit their written observations by 4 October 2021 on the judgments of 30 January 2020, Generics (UK) and Others (C‑307/18, EU:C:2020:52); of 25 March 2021, Lundbeck v Commission (C‑591/16 P, EU:C:2021:243); of 25 March 2021, Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission (C‑586/16 P, EU:C:2021:241); of 25 March 2021, Generics (UK) v Commission (C‑588/16 P, EU:C:2021:242); of 25 March 2021, Arrow Group and Arrow Generics v Commission (C‑601/16 P, EU:C:2021:244); and of 25 March 2021, Xellia Pharmaceuticals and Alpharma v Commission (C‑611/16 P, EU:C:2021:245). The parties complied with that request within the prescribed period.
33 By its appeal, the Commission claims that the Court should:
– set aside points 1 to 4 of the operative part of the judgment under appeal;
– refer the case back to the General Court; and
– order Krka to pay the costs.
34 Krka claims that the Court should:
– dismiss the appeal in its entirety; and
– order the Commission to pay the costs.
35 The United Kingdom of Great Britain and Northern Ireland waived the right to lodge a statement in intervention.
V. The request that the oral part of the procedure be reopened
36 By document lodged at the Court Registry on 7 September 2022, Krka requested that the oral part of the procedure be reopened. In support of that request, Krka invokes the need to respond to the Opinion of the Advocate General in Commission v Servier and Others (C‑176/19 P, EU:C:2022:576), as a result of associative links between that case and the present appeal. In that regard, Krka claims in essence that that Opinion, although directly relevant to the present case, was delivered without the Advocate General defining her position on the arguments and evidence put forward by Krka in the present case.
37 According to Krka, that evidence shows that there was no market-sharing agreement. First, the Krka settlement agreement did not prevent Krka from developing a perindopril other than that composed of the alpha crystalline form of erbumine protected by the 947 patent. Second, Krka developed and launched, on markets where Servier held a patent, a generic version of perindopril which did not infringe the 947 patent. Third, Krka’s exclusion from the markets other than those covered by the Krka licence agreement is the result not of an agreement to share markets but of the protection arising from that patent. Fourth, because Krka held marketing authorisations only for its own perindopril, it could not have entered the markets where Servier enjoyed the protection of that patent. Fifth, Krka had recognised the validity of that patent and, as a result, decided to settle its disputes with Servier. Accordingly, had an Opinion been heard in this case, the Advocate General appointed could not have failed to confirm the outcome adopted by the General Court in the judgment under appeal.
38 In that regard, it should be borne in mind that the Statute of the Court of Justice of the European Union and the Rules of Procedure of the Court of Justice make no provision for the parties to submit observations in response to the Advocate General’s Opinion (judgment of 31 January 2023, Puig Gordi and Others, C‑158/21, EU:C:2023:57, paragraph 37 and the case-law cited).
39 It is true that the Court may at any time, after hearing the Advocate General, order the reopening of the oral part of the procedure, in accordance with Article 83 of its Rules of Procedure, in particular if it considers that it lacks sufficient information or where the case must be decided on the basis of an argument which has not been debated between the parties.
40 In the present case, the Court finds, having heard the Advocate General, that the request that the oral part of the procedure be reopened submitted by Krka seeks exclusively to respond to the Opinion of the Advocate General in Commission v Servier and Others (C‑176/19 P, EU:C:2022:576), and does not invoke any elements that the parties were unable to debate in the written and oral parts of the procedure in the present case. Since the Court has at its disposal, at the close of the written and oral parts of the procedure, all the elements necessary, it is therefore sufficiently informed to make a ruling on the present appeal, and it is not necessary to decide the present case on the basis of arguments which have not been debated between the parties.
41 In the light of the foregoing, there is no need to grant the request that the oral part of the procedure be reopened.
VI. The appeal
42 In support of its appeal, the Commission raises seven grounds. By its first to sixth grounds of appeal, the Commission claims that the General Court erred in law in finding that the Krka agreements did not constitute a restriction of competition by object within the meaning of Article 101(1) TFEU. By its seventh ground of appeal, the Commission submits that the General Court erred in law in finding that the Commission had not established that those agreements constituted a restriction of competition by effect.
A. The first to sixth grounds of appeal, relating to the existence of a restriction of competition by object within the meaning of Article 101(1) TFEU
43 The first ground of appeal is directed against the General Court’s assessment of the potential competition from Krka. The second and third grounds of appeal relate to the existence of a market-sharing agreement between Servier and Krka. The fourth ground of appeal addresses the General Court’s assessment of the intentions of those undertakings. The fifth ground of appeal concerns the taking into account of the procompetitive effects of the Krka licence agreement. The sixth ground of appeal is directed against the characterisation of the Krka assignment and licence agreement as a restriction of competition by object.
1. The relevant sections of the decision at issue and the relevant paragraphs of the judgment under appeal
(a) The decision at issue
44 In recitals 1670 to 1859 of the decision at issue, the Commission assessed the Krka agreements in the light of Article 101 TFEU. For the reasons set out in recitals 1670 to 1812 of that decision, it found that those agreements constituted a single and continuous infringement the object of which was to restrict competition by sharing the markets for perindopril in the European Union between those two undertakings.
45 First, it is apparent from recitals 1701 to 1763 of the decision at issue that the object of the Krka settlement and licence agreements was to share and allocate the EU markets between Servier and Krka. The licence agreement authorised Krka to continue or to start marketing a generic version of perindopril as part of a de facto duopoly with Servier in Krka’s core markets. That authorisation was the quid pro quo for Krka’s commitment, under the Krka settlement agreement, to refrain from competing with Servier in the other national markets in the territory of the European Union, which constitute Servier’s core markets (‘Servier’s core markets’). The Commission therefore considered that that licence agreement represented the inducement offered by Servier for Krka to accept the restrictions agreed in the Krka settlement agreement.
46 Second, the Commission found, in recitals 1764 to 1810 of the decision at issue, that the Krka assignment and licence agreement had made it possible for the parties to strengthen their competitive position, as it resulted from the Krka settlement and licence agreements, by preventing Krka from assigning its technology for the production of perindopril to other manufacturers of generic medicines who could then have used it to market generic versions of that medicinal product on Servier’s core markets. Since the payment by Servier to Krka of the sum of EUR 30 million was unconnected with the income that Servier could achieve or expect from the commercial exploitation of the technology thus transferred by Krka, the payment of that sum was viewed by the Commission as a sharing of the revenues resulting from the reinforcement of market allocation between Servier and Krka.
(b) The judgment under appeal
47 The General Court set out, in the first place, in paragraphs 134 to 153 of the judgment under appeal, the conditions under which the insertion, into patent dispute settlement agreements, of non-challenge clauses in respect of patents and non-marketing clauses in respect of generic products is anticompetitive. According to the General Court, such an insertion is anticompetitive if it is based not on the parties’ recognition of the validity of the patent and of the infringing nature of the generic products concerned, but on a significant and unjustified reverse payment made by the patent holder to the manufacturer of generic medicines, which induces the latter to agree to those clauses. The General Court found, in paragraph 150 of the judgment under appeal, that, where they involve such an inducement, agreements of that nature must be regarded as market exclusion agreements, by which the ‘stayers’ are to compensate the ‘goers’.
48 In the second place, the General Court explained, in paragraphs 164 to 177 of the judgment under appeal, that, where a normal commercial agreement is linked to a patent dispute settlement agreement including non-marketing and non-challenge clauses, such a contractual arrangement must be regarded as anticompetitive if the value transferred by the patent holder to the manufacturer of generic medicines under the commercial agreement exceeds the value of the asset transferred by that company pursuant to that agreement. In other words, such a contractual arrangement must be regarded as anticompetitive if the normal commercial agreement linked to the settlement agreement serves, in reality, to mask a value transfer from the patent holder to the manufacturer of generic medicines, for which there is no quid pro quo other than that manufacturer’s undertaking not to compete.
49 In the third place, the General Court ruled, in paragraphs 179 to 268 of the judgment under appeal, on the particular situation of the linking of a settlement agreement with a licence agreement, such as the linking resulting from the Krka settlement and licence agreements. It took the view that, in such a situation, the considerations relevant to the linking of a settlement agreement with a normal commercial agreement, summarised in the preceding paragraph of the present judgment, do not apply. It is apparent from paragraphs 179 to 183 of the judgment under appeal that the linking of a settlement agreement to a licence agreement is an appropriate means of resolving a dispute, allowing the generic company to enter the market and satisfying the wishes of both parties. Moreover, the presence, in a settlement agreement, of non-marketing and non-challenge clauses is legitimate where that agreement is based on the parties’ recognition of the validity of the patent. A licence agreement, which is meaningful only if the licence is actually used, is necessarily based on the parties’ recognition of the validity of the patent.
50 In paragraphs 184 and 188 of the judgment under appeal, the General Court held that, in order to establish that the linking of a settlement agreement with a licence agreement in fact masks a reverse payment from the patent holder to the manufacturer of generic medicines, the Commission must demonstrate that the royalty paid to the patent holder under that licence agreement by that manufacturer is abnormally low.
51 The General Court, in essence, stated in paragraphs 189 to 192 of the judgment under appeal that the abnormally low level of that royalty must be particularly clear for the purpose of characterising a settlement agreement as a restriction of competition by object, since the anticompetitive nature of the non-marketing and non-challenge clauses in that agreement is mitigated by the procompetitive effect of the licence agreement, which would encourage the entry of the manufacturer of generic medicines on the market.
52 The General Court concluded, in paragraph 199 of the judgment under appeal, that ‘where there is a genuine dispute involving litigation between the parties concerned and a licence agreement that is directly connected with the settlement of that dispute, the linking of that agreement to the settlement agreement does not constitute a strong indication of the existence of a reverse payment. In such circumstances, it is therefore for the Commission to demonstrate, on the basis of other evidence, that the licence agreement does not constitute a transaction concluded at arm’s length and thus masks a reverse payment’.
53 It was in the light of those factors that the General Court examined, in paragraphs 200 to 267 of the judgment under appeal, the Krka settlement and licence agreements, and reached the conclusion, in paragraph 268 of that judgment, that those agreements did not reveal ‘a sufficient degree of harm to competition that the Commission could validly conclude that they constituted a restriction [of competition] by object’.
2. Preliminary considerations relating to the examination of the substance of the first to sixth grounds of appeal
54 Before examining the merits of the grounds of appeal relating to the existence of a restriction of competition by object, it should be noted that, unlike the circumstances underlying the cases in which the Court was called upon to rule on the legal characterisation, in the light of Article 101 TFEU, of agreements under which a manufacturer of originator medicines compensated a manufacturer of generic medicines economically in return for the latter’s refraining from entering the market, in particular the cases which gave rise to the judgments of 30 January 2020, Generics (UK) and Others (C‑307/18, EU:C:2020:52), and of 25 March 2021, Lundbeck v Commission (C‑591/16 P, EU:C:2021:243), and unlike the other agreements concluded by Servier that formed the subject matter of the decision at issue, the Krka settlement and licence agreements did not provide for any payment from the manufacturer of originator medicines to the manufacturer of generic medicines. On the contrary, the Krka licence agreement provided for payments from the manufacturer of generic medicines to the manufacturer of originator medicines.
55 On the other hand, according to recitals 1731 to 1749 of the decision at issue, the Krka settlement and licence agreements allowed Servier to delay the entry into the market of generic medicines produced by Krka. In the territory of the European Union, it is alleged that those two undertakings divided the national markets into two spheres of influence, comprising, for each of them, their core markets, within which they could operate in the assurance, in the case of Servier, that it would not be subject to competitive pressure from Krka beyond the limits resulting from those agreements and, in the case of Krka, that it would not run the risk of being sued for infringement by Servier.
56 While it is therefore clear from the evidence in the decision at issue that Servier did not make any reverse payment as such to Krka under the Krka settlement agreement, it is also clear, according to the Commission, that those undertakings geographically divided the various national markets within the European Union. It will therefore be necessary to take those circumstances into consideration in order to rule, in particular, on the second and third grounds of appeal, and to assess whether, and if so to what extent, the Commission’s line of argument seeking to call into question the legal criteria on the basis of which the General Court upheld the pleas at first instance relied on by Krka to challenge the characterisation of the Krka settlement and licence agreements as a restriction of competition by object is well founded.
57 In that regard, it should be recalled that Article 101(1) TFEU states that all agreements between undertakings, decisions by associations of undertakings and concerted practices which may affect trade between Member States and which have as their object or effect the prevention, restriction or distortion of competition within the internal market are incompatible with the internal market and are prohibited.
58 Accordingly, if the conduct of undertakings is to be subject to the prohibition in principle laid down in Article 101(1) TFEU, that conduct must reveal the existence of coordination between them, in other words, an agreement between undertakings, a decision by an association of undertakings or a concerted practice (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 31 and the case-law cited).
59 The latter requirement means, with respect to horizontal cooperation agreements entered into by undertakings that operate at the same level of the production or distribution chain, that the coordination involves undertakings which are in competition with each other, if not in reality, then at least potentially (judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 32).
60 In addition, it is necessary to demonstrate, in accordance with the very wording of that provision, either that that conduct has as its object the prevention, restriction or distortion of competition, or that that conduct has such an effect (judgment of 21 December 2023, European Superleague Company, C‑333/21, EU:C:2023:1011, paragraph 158). It follows that that provision, as interpreted by the Court, makes a clear distinction between the concept of restriction by object and the concept of restriction by effect, each of those concepts being subject to different rules with regard to what must be proved (judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 63).
61 Accordingly, as regards practices characterised as restrictions of competition by object, there is no need to investigate nor a fortiori to demonstrate their effects on competition, in so far as experience shows that such behaviour leads to falls in production and price increases, resulting in poor allocation of resources to the detriment, in particular, of consumers (see, to that effect, judgments of 19 March 2015, Dole Food and Dole Fresh Fruit Europe v Commission, C‑286/13 P, EU:C:2015:184, paragraph 115, and of 21 December 2023, European Superleague Company, C‑333/21, EU:C:2023:1011, paragraph 159).
62 On the other hand, where the anticompetitive object of an agreement, a decision by an association of undertakings or a concerted practice is not established, it is necessary to examine its effects in order to prove that competition has in fact been prevented or restricted or distorted to an appreciable extent (see, to that effect, judgment of 26 November 2015, Maxima Latvija, C‑345/14, EU:C:2015:784, paragraph 17).
63 That distinction arises from the fact that certain forms of collusion between undertakings can be regarded, by their very nature, as being injurious to the proper functioning of normal competition (judgments of 20 November 2008, Beef Industry Development Society and Barry Brothers, C‑209/07, EU:C:2008:643, paragraph 17, and of 14 March 2013, Allianz Hungária Biztosító and Others, C‑32/11, EU:C:2013:160, paragraph 35). The concept of restriction of competition by object must be interpreted strictly and can be applied only to certain agreements between undertakings which reveal, in themselves and having regard to the content of their provisions, their objectives, and the economic and legal context of which they form part, a sufficient degree of harm to competition for the view to be taken that it is not necessary to assess their effects (see, to that effect, judgments of 26 November 2015, Maxima Latvija, C‑345/14, EU:C:2015:784, paragraph 20, and of 21 December 2023, European Superleague Company, C‑333/21, EU:C:2023:1011, paragraphs 161 and 162 and the case-law cited).
64 The Court has already held that market-sharing agreements constitute particularly serious breaches of the competition rules (see, to that effect, judgments of 11 July 2013, Gosselin Group v Commission, C‑429/11 P, EU:C:2013:463, paragraph 50; of 5 December 2013, Solvay Solexis v Commission, C‑449/11 P, EU:C:2013:802, paragraph 82; and of 4 September 2014, YKK and Others v Commission, C‑408/12 P, EU:C:2014:2153, paragraph 26). The Court has moreover held that agreements of that nature have, in themselves, an object restrictive of competition and fall within a category of agreements expressly prohibited by Article 101(1) TFEU, and that such an object cannot be justified by an analysis of the economic context of the anticompetitive conduct concerned (judgment of 19 December 2013, Siemens and Others v Commission, C‑239/11 P, C‑489/11 P and C‑498/11 P, EU:C:2013:866, paragraph 218).
65 As regards such categories of agreements, it is thus only if Article 101(3) TFEU applies and all of the conditions provided for in that provision are observed that they may be granted the benefit of an exemption from the prohibition laid down in Article 101(1) TFEU (see, to that effect, judgments of 20 November 2008, Beef Industry Development Society and Barry Brothers, C‑209/07, EU:C:2008:643, paragraph 21, and of 21 December 2023, European Superleague Company, C‑333/21, EU:C:2023:1011, paragraph 187).
66 The implementation of the principles set out above with regard to collusive practices in the form of horizontal cooperation agreements between undertakings, such as the Krka agreements, involves determining, at an initial stage, whether those practices may be classified as a restriction of competition by undertakings which are in competition with each other, even if only potentially. If that is the case, it is necessary to ascertain, at a second stage, whether, in the light of their economic characteristics, those practices fall within the characterisation of a restriction of competition by object.
67 As regards the first stage of that analysis, the Court has already held that, in the specific context of the opening of the market for a medicinal product to the manufacturers of generic medicines, it is necessary to determine, in order to assess whether one of those manufacturers, although absent from a market, is a potential competitor of a manufacturer of originator medicines present in that market, whether there are real and concrete possibilities of the former moving into that market and competing with the latter (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 36 and the case-law cited).
68 Thus, it is necessary to assess, first, whether, at the time those agreements were concluded, the manufacturer of generic medicines had taken sufficient preparatory steps to enable it to enter the market concerned within such a period of time as would impose competitive pressure on the manufacturer of originator medicines. Such steps permit the conclusion that a manufacturer of generic medicines has a firm intention and an inherent ability to enter the market of a medicine containing an active ingredient that is in the public domain, even when there are process patents held by the manufacturer of originator medicines. Second, it must be determined that the market entry of such a manufacturer of generic medicines does not meet barriers to entry that are insurmountable (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraphs 43 to 45).
69 The Court has already held that any patents protecting an originator medicine or one of its manufacturing processes are indisputably part of the economic and legal context characterising the relationships of competition between the holders of those patents and the manufacturers of generic medicines. However, the assessment of the rights conferred by a patent must not consist in a review of the strength of the patent or of the probability of a dispute between the patent holder and a manufacturer of generic medicines concluding with a finding that the patent is valid and has been infringed. That assessment must rather concern the question whether, notwithstanding the existence of that patent, the manufacturer of generic medicines has real and concrete possibilities of entering the market at the relevant time (judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 50).
70 Furthermore, a finding of potential competition between a manufacturer of generic medicines and a manufacturer of originator medicines can be confirmed by additional factors, such as the conclusion of an agreement between them when the manufacturer of generic medicines was not present on the market concerned, or the existence of transfers of value to that manufacturer in exchange for the postponement of its market entry (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraphs 54 to 56).
71 At a second stage of that analysis, in order to determine whether a delay in the market entry of generic medicines, as the result of a patent dispute settlement agreement, in exchange for transfers of value by the manufacturer of originator medicines to the manufacturer of those generic medicines must be regarded as a collusive practice constituting a restriction of competition by object, it is necessary to examine first of all whether those transfers of value may be fully justified by the need to compensate for the costs of or disruption caused by that dispute, such as the expenses and fees of the latter manufacturer’s advisers, or by the need to provide remuneration for the actual and proven supply of goods or services by the manufacturer of generic medicines to the manufacturer of the originator medicine. If that is not the case, it must be ascertained whether those transfers of value can have no explanation other than the commercial interest of those manufacturers of medicinal products not to engage in competition on the merits. For the purposes of that analysis, it is necessary, in each individual case, to assess whether the net gain from the transfers of value was sufficiently large actually to act as an incentive to the manufacturer of generic medicines to refrain from entering the market concerned and, therefore, not to compete on the merits with the manufacturer of originator medicines, without its being necessary for that net gain necessarily to be greater than the profits which the manufacturer of generic medicines would have made if it had been successful in the patent proceedings (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraphs 84 to 94).
72 In that regard, it must be borne in mind that challenges to the validity and scope of a patent are part of normal competition in the sectors where there exist exclusive rights in relation to technology, so that settlement agreements whereby a manufacturer of generic medicines that is seeking to enter a market recognises, at least temporarily, the validity of a patent held by a manufacturer of originator medicines and gives an undertaking, as a result, not to challenge that patent nor indeed to enter that market are liable to restrict competition (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 81 and the case-law cited).
73 In the light of the foregoing, the General Court was required to apply the criteria set out in paragraphs 71 and 72 of the present judgment in order to rule on those of Krka’s arguments, invoked in particular in the context of the third plea at first instance, that relate to the existence of a restriction of competition by object and thus to determine whether the Commission was entitled, in the decision at issue, to find the existence of such a restriction.
74 Thus, once the existence of the elements relating to potential competition, which are the subject of the first ground of appeal, had been established, the General Court needed, at that second stage, to ascertain whether the Krka settlement and licence agreements constituted a market-sharing agreement which restricted competition by object within the meaning of Article 101(1) TFEU, a category of agreements expressly prohibited by that provision. The General Court was required to examine, in that context, the objectives of those agreements and the economic link which existed between them, according to the decision at issue, and, more specifically, whether the transfer of value by Servier to Krka by means of the Krka licence agreement was sufficiently significant to induce Krka to share markets with Servier, by refraining, even if only temporarily, from entering Servier’s core markets in return for the assurance that it would be able to market its generic version of perindopril on its own core markets without incurring the risk that it would be the subject of patent infringement actions brought by Servier.
75 Furthermore, the General Court had to take into account the intentions of the undertakings involved, in order to ascertain whether, in the light of the factors referred to in the preceding paragraph, those intentions bore out its analysis of the objective aims that those undertakings were seeking to achieve from a competition standpoint, bearing in mind nevertheless that, according to the case-law of the Court of Justice, the fact that those undertakings acted without having an intention to prevent, restrict or distort competition and the fact that they pursued certain legitimate objectives are not decisive for the purposes of the application of Article 101(1) TFEU (judgment of 21 December 2023, European Superleague Company, C‑333/21, EU:C:2023:1011, paragraph 167 and the case-law cited).
3. The first ground of appeal
76 By its first ground of appeal, which is divided into five parts, the Commission disputes the General Court’s finding that Krka no longer represented a source of competitive pressure on Servier when the Krka settlement and licence agreements were concluded.
(a) The first and second parts
(1) Arguments of the parties
77 By the first part of its first ground of appeal, directed against paragraphs 262 and 400 of the judgment under appeal, the Commission disputes the General Court’s finding that the fact that Krka continued to exert competitive pressure on Servier after the EPO decision of 27 July 2006 could be explained by Krka’s desire to strengthen its position in the negotiations with Servier with a view to concluding the Krka settlement agreement. The General Court seems to have found that Krka was no longer a potential competitor of Servier, without applying the appropriate legal test, that is to say, the test consisting in examining whether there were real and concrete possibilities of Krka entering Servier’s core markets. Furthermore, the General Court relied on a subjective factor – Krka’s desire to strengthen its position in the negotiations with Servier – which is irrelevant for the purposes of assessing that potential competition. Moreover, the General Court substituted its own assessment for that of the Commission by holding that Krka continued to exert competitive pressure on Servier after that EPO decision only in order to strengthen its position in negotiations with that undertaking, but did not explain why Krka was allegedly unable, in the absence of the agreements at issue, to enter the market.
78 By the second part of its first ground of appeal, the Commission submits that the findings made by the General Court, in paragraphs 206, 243, 264 and 392 of the judgment under appeal, relating to Krka’s recognition of the validity of the 947 patent and of the EPO decision of 27 July 2006, were made in infringement of the rules on the production of evidence. By failing to rule on Krka’s second plea at first instance, alleging that there was no potential competition, the General Court failed to take into account all relevant evidence and failed to observe the proper scope of the review of legality which it is required to carry out under Article 263 TFEU with regard to Commission decisions relating to proceedings applying Articles 101 and 102 TFEU.
79 Krka submits that the first part is based on a misreading of the judgment under appeal. Contrary to the Commission’s claim, paragraphs 262 and 400 of that judgment do not address the topic of potential competition exerted by Krka on Servier. Furthermore, it is clear from paragraphs 48 and 49 of that judgment that the intention of the General Court was not to respond to the second plea at first instance, relating to potential competition. In any event, evidence contemporaneous to the date on which the Krka settlement and licence agreements were concluded confirms that Krka and Servier were, at that time, neither actual nor potential competitors.
80 As regards the second part, Krka submits that, under the guise of alleging that an incorrect legal test had been applied in order to assess whether there was potential competition, the Commission is seeking to call into question the factual assessments by the General Court to the effect that Servier and Krka had objective reasons for believing the 947 patent to be valid. The assertion that the General Court was required to review the evidence and reasoning provided by the Commission relating to potential competition is unfounded, in accordance with the case-law of the Court of Justice. Once it had upheld the pleas relating to the absence of a restriction of competition by object and by effect, the General Court was not required to rule on the plea alleging the absence of potential competition.
(2) Findings of the Court
81 Krka claims, in essence, that the second part of the first ground of appeal is inadmissible because the Commission’s arguments are aimed at requesting the Court to carry out a new assessment of the facts.
82 In that regard, it should be recalled that it is apparent from Article 256(1) TFEU and the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union that an appeal is to be limited to points of law and that the General Court therefore has sole jurisdiction to find and appraise the relevant facts and evidence. The assessment of the facts and evidence does not, save where the facts or evidence are distorted, constitute a point of law, which is subject, as such, to review by the Court of Justice on appeal. Such a distortion must be obvious from the documents on the Court’s file, without there being any need to carry out a new assessment of the facts and evidence (judgment of 10 July 2019, VG v Commission, C‑19/18 P, EU:C:2019:578 paragraph 47 and the case-law cited).
83 However, where the General Court has found or appraised the facts, the Court of Justice has jurisdiction to carry out a review, provided that the General Court has defined their legal nature and determined the legal consequences. The jurisdiction of the Court of Justice to review extends, inter alia, to the question whether the General Court has taken the right legal criteria as the basis for its appraisal of the facts (see, to that effect, judgment of 2 March 2021, Commission v Italy and Others, C‑425/19 P, EU:C:2021:154, paragraph 53 and the case-law cited).
84 In the present case, by the second part of its first ground of appeal, the Commission submits that the General Court failed, first, to rule on the complaints relating to potential competition developed in the context, inter alia, of the second plea in the action at first instance and, second, to analyse the reasoning and all of the evidence relating to potential competition set out in recitals 1686 to 1690 of the decision at issue, thereby infringing the rules governing the production of evidence and the scope of judicial review. Contrary to Krka’s submission, those arguments concern points of law and therefore fall within the jurisdiction of the Court of Justice in the context of an appeal, in accordance with the case-law cited in paragraphs 82 and 83 of the present judgment.
85 On the substance, by the first two parts of its first ground of appeal, the Commission submits, in essence, that the General Court, in its analysis of the characterisation of the Krka agreements in the light of the concept of a restriction of competition by object, took into consideration Krka’s alleged recognition of the validity of the 947 patent, relying, inter alia, on an incorrect legal test, on an incomplete assessment of the evidence set out in the decision at issue and on an irrelevant subjective factor and, by doing so, failed to observe the proper scope of the review of legality which it was required to carry out in relation to that decision. The Commission submits, in particular, that the General Court could not take a view on Krka’s alleged recognition of the validity of the 947 patent without examining the evidence referred to in the decision at issue from which it is clear that Krka was a potential competitor of Servier. According to that institution, that evidence shows that Krka, which had both a firm intention and an inherent ability to enter the perindopril market, was a potential competitor of Servier.
86 In the first place, it is necessary to reject Krka’s claim that the Commission’s line of argument developed in the context of the first part of the first ground of appeal is the result of a misreading of the judgment under appeal.
87 The General Court found, first of all, in paragraph 206 of the judgment under appeal, that there were, at the time the Krka settlement and licence agreements were concluded, ‘consistent indications capable of leading the parties to believe that the 947 patent was valid’; and, then, in paragraph 207 of that judgment, that the EPO decision of 27 July 2006 confirming the validity of the 947 patent had therefore been ‘one of the driving factors leading to the settlement and licence agreements’. It inferred, lastly, in paragraph 208 of that judgment that ‘the linking of those two agreements was justified and therefore [did] not constitute a strong indication of … a reverse payment from Servier to Krka giving rise to the licence agreement’.
88 Similarly, the General Court considered, in paragraph 262 of the judgment under appeal, that the fact that Krka had continued to challenge Servier’s patents and to market its product even though the validity of the 947 patent had been upheld by the EPO Opposition Division was not a decisive factor for the purpose of establishing the existence of a restriction of competition by object, since the fact that Krka continued to exert competitive pressure on Servier can be explained by Krka’s desire, despite the expected litigation risks, to strengthen its position in the negotiations that it was likely to have with Servier with a view to reaching a settlement.
89 That reasoning is understandable only if it is considered that the General Court necessarily held that, after the EPO had confirmed the validity of the 947 patent, Krka’s perindopril, composed of the alpha crystalline form of erbumine protected by that patent, could no longer compete with Servier’s perindopril, thus putting an end to all potential competition between those undertakings. From that point of view, the Krka settlement agreement, by which that undertaking refrained from entering Servier’s markets, merely reflects the rights arising from that patent and cannot therefore be perceived as the real consideration for Servier’s grant of a licence to that patent on Krka’s core markets. The General Court expressly stated in paragraphs 471 and 472 of the judgment under appeal that it had to be concluded ‘without there being any need to examine the other pleas in law, that the Commission erred in finding an infringement under Article 101(1) TFEU as regards the agreements between Servier and Krka’ and, therefore, Article 4 of the decision at issue had to be annulled. It is therefore clear from those grounds, read in the light of paragraphs 48 and 49 of that judgment, that the General Court made those findings without ruling on the second plea of Krka’s action at first instance, alleging the absence of potential competition. However, it is apparent from the grounds which led to the annulment of that decision that the General Court did in fact examine certain complaints falling within the scope of that plea and a number of recitals of that decision which relate to the issue of potential competition between Krka and Servier.
90 It is apparent from the findings made, inter alia, in paragraphs 179 to 268 and 378 to 471 of the judgment under appeal that the General Court relied decisively on Krka’s alleged recognition of the validity of the 947 patent following the EPO decision of 27 July 2006 and that of the High Court of 3 October 2006, as regards the characterisation of the Krka agreements both as a restriction of competition by object and as a restriction of competition by effect. Since the General Court considered that the possibility of Krka’s entering Servier’s core markets in order to compete with Servier depended essentially on whether, at the date of the Krka agreements, Krka recognised the validity of the 947 patent, and Krka’s status as a potential competitor to Servier resulting from the possibility of Krka’s entering those markets, it must be held that there is a close link between that alleged recognition and Krka’s status as a potential competitor to Servier.
91 In those circumstances, contrary to Krka’s assertion, the fact that the General Court, after upholding that undertaking’s line of argument relating to the existence of an infringement of Article 101(1) TFEU, stated in paragraph 471 of the judgment under appeal that, since the pleas relating to the absence of a restriction of competition by object and the plea relating to the absence of a restriction of competition by effect were well founded, it was necessary to conclude that the Commission erred in finding an infringement of Article 101 TFEU as regards the Krka agreements, ‘without there being any need to examine the other pleas in law’, which included the second plea in that action, therefore does not mean that the first part of the Commission’s first ground of appeal is based on a misreading of that judgment. It is apparent, in particular, from paragraphs 203, 204 and 206 to 208 of that judgment that the General Court, by holding that, at the time the Krka settlement and licence agreements were concluded, there were consistent indications capable of leading Servier and Krka to believe that the 947 patent was valid, inferred from those indications that competition between those undertakings on the national markets within the European Union was now precluded and that there was no potential competition between them. In so doing, it necessarily examined certain complaints put forward by Krka at first instance relating to potential competition.
92 In the second place, the General Court was required to apply the criteria set out in paragraphs 67 to 70 of the present judgment in order to rule on those arguments invoked by Krka, in particular, in the context of its second plea at first instance, that relate to potential competition and thus to determine whether the Commission had been entitled, in the decision at issue, to conclude that Krka was a potential competitor of Servier at the time the Krka agreements were concluded.
93 In view of the characteristics of the infringement of Article 101 TFEU found in the decision at issue, the General Court therefore had to examine whether those agreements had been concluded between undertakings in a potential competitive relationship and could be classified as a restriction of competition. To that end, that court was required to ascertain whether the Commission had been right to consider that, on the date those agreements were concluded, there were real and concrete possibilities that Krka would enter the relevant market and compete with Servier, in view of sufficient preparatory steps and the absence of insurmountable barriers to that entry, and it was possible to confirm the finding of potential competition, where appropriate, by additional factors, such as the existence of a transfer of value to Krka in exchange for the postponement of its market entry.
94 Admittedly, where the validity of a patent protecting an originator medicine or one of its manufacturing processes has been definitively established before all the courts before which that question has been brought, it would hardly be conceivable that other aspects of the economic and legal context characterising objectively the competitive relationships between the holder of those patents and a manufacturer of generic medicines could justify the conclusion that there is still a potential competitive relationship between them. However, where disputes between them on the question of the validity of the patent in question are still pending, it is for the administrative authority or the competent court to examine all the relevant evidence before reaching the conclusion that that holder and that manufacturer are not potential competitors, as is apparent from the case-law referred to in paragraph 69 of the present judgment.
95 However, instead of applying the criteria set out in paragraphs 67 to 70, 93 and 94 of the present judgment in order to carry out the necessary verifications to determine whether Krka was a potential competitor of Servier, as it was required to do, the General Court merely stated, in essence, in particular in paragraphs 206, 262 and 264 of the judgment under appeal, that those two undertakings were convinced that the 947 patent was valid and, without specific reasons or supporting evidence, that Krka’s conduct consisting in maintaining competitive pressure on Servier could be explained by Krka’s desire to strengthen its position in the negotiations that it was likely to have with Servier with a view to reaching a settlement agreement accompanied by a licence agreement, the obtaining of such a licence having become the commercial solution preferred by Krka on the perindopril market.
96 It follows that the first part of the first ground of appeal is well founded. The General Court was mistaken as to the legal relevance of the patent situation found to exist on the markets in question, as well as of the parties’ intentions, and erred in law in the application of Article 101(1) TFEU by assessing the concept of potential competition according to incorrect criteria.
97 As regards the second part of the first ground of appeal, the General Court was required, in accordance with what has been held in paragraph 94 of the present judgment and in the light of the case-law cited in paragraph 69 thereof, to take into account all the relevant factors on the basis of which the Commission considered, in the decision at issue, that Krka and Servier were in a potential competitive relationship. By limiting, in essence, its analysis of the relationship between those two undertakings, on the date of conclusion of the Krka settlement and licence agreements, to the patent situation alone and, in particular, to the perception that Krka may have had of the validity of the 947 patent, as well as to the parties’ intentions, in the light more particularly of the EPO decision of 27 July 2006 and that of the High Court of 3 October 2006, the General Court infringed that obligation.
98 Not only did the General Court err in law as regards the review which it is required to conduct of Commission decisions relating to proceedings under Articles 101 and 102 TFEU, but it also infringed its obligation under Article 36 of the Statute of the Court of Justice of the European Union, applicable to the General Court by virtue of the first paragraph of Article 53 thereof, to state the reasons on which its judgments are based, having failed to set out, in paragraph 206 of the judgment under appeal, the reasons on which it relied in order to find implicitly, in that paragraph, that Servier and Krka were no longer potential competitors, even though the evidence set out, inter alia, in recitals 1686 to 1690 of the decision at issue was aimed at demonstrating the contrary. The fact that the General Court did not expressly state that it had ruled out the existence of potential competition between Krka and Servier is not such as to call into question that finding relating to a failure to state reasons. It cannot be accepted that the General Court may, by failing to set out an essential step in its own reasoning, dispense with its obligation to state the reasons on which its judgments are based and thus prevent the Court of Justice from being in a position to exercise its power of review on appeal.
99 It follows that the first and second parts of the first ground of appeal must be upheld.
(b) The third and fifth parts
(1) Arguments of the parties
100 By the third and fifth parts of its first ground of appeal, directed against paragraphs 203, 204, 206, 235 and 261 to 264 and paragraphs 253, 260 and 387, respectively, of the judgment under appeal, the Commission alleges that the General Court distorted the EPO decision of 27 July 2006 and the decision of the High Court of 3 October 2006.
101 In the first place, those distortions vitiated the General Court’s finding that there were consistent indications capable of leading the parties to believe that the 947 patent was valid. Similarly, those distortions affected the General Court’s finding that recognition of the validity of the 947 patent led Krka to prefer to enter its own core markets with the benefit of the protection conferred by the Krka licence agreement, rather than to enter Servier’s core markets and expose itself to the risk of being the subject of infringement actions.
102 In the second place, the Commission criticises the General Court for concluding, in paragraph 253 of the judgment under appeal, that the EPO decision of 27 July 2006 and the decision of the High Court of 3 October 2006 had ‘substantially altered the context in which the [Krka settlement and licence agreements] were concluded, in particular as regards the perception that Krka, as well as Servier, could have of the validity of the 947 patent’. In its view, no document contemporary to those agreements serves to support that finding. On the contrary, the evidence available to the General Court – in particular that relating to the rejection of an injunction applied for by Servier in Hungary – and the temporary nature of the injunctions obtained by Servier, have the effect of invalidating that finding. The Commission also claims in that context that the reasoning of the judgment under appeal is insufficient and contradictory.
103 Krka submits that those third and fifth parts are inadmissible. The third part, it claims, does not precisely identify the evidence that was allegedly distorted or indicate the errors of appraisal purportedly committed by the General Court. Furthermore, the Commission is attempting to have the Court of Justice reassess the facts. As regards the fifth part, the Commission is seeking, by that part, to have the Court of Justice reassess the evidence.
104 On the substance, Krka submits that the third and fifth parts are unfounded. The General Court carried out a thorough examination of all the evidence showing that, after the EPO decision of 27 July 2006, Krka had accepted the validity of the 947 patent and continued its litigation solely in order to strengthen its position with view to negotiating a settlement agreement with Servier. The complaint that the temporary nature of the injunctions obtained by Servier contradicts the General Court’s assessment is manifestly unfounded. Indeed, Krka’s access to Servier’s core markets is, Krka submits, a separate matter from that undertaking’s recognition of the validity of the 947 patent.
(2) Findings of the Court
105 As regards the admissibility of the third and fifth parts of the first ground of appeal, it should be borne in mind that, on appeal, complaints based on findings of fact and on the assessment of those facts in the contested decision are admissible on appeal where it is claimed that the General Court has made findings which the documents in the file show to be substantially incorrect or that it has distorted the clear sense of the evidence before it (judgment of 18 January 2007, PKK and KNK v Council, C‑229/05 P, EU:C:2007:32, paragraph 35).
106 That distortion must be obvious from the documents in the Court’s file, without there being any need to carry out a new appraisal of the facts and the evidence (judgment of 28 January 2021, Qualcomm and Qualcomm Europe v Commission, C‑466/19 P, EU:C:2021:76, paragraph 43). Although such a distortion may consist in an interpretation of a document that is at odds with its content, that must be manifestly clear from the file and the General Court must have manifestly exceeded the limits of a reasonable assessment of the evidence. In that regard, it is not sufficient to show that a document could be interpreted in a different way from that adopted by the General Court (judgment of 17 October 2019, Alcogroup and Alcodis v Commission, C‑403/18 P, EU:C:2019:870, paragraph 64 and the case-law cited).
107 Contrary to Krka’s submissions, the Commission precisely identified the evidence the distortion of which it alleges, that is to say, the EPO decision of 27 July 2006 and the decision of the High Court of 3 October 2006.
108 Before examining the substance of the Commission’s complaints alleging distortion, it should be noted at the outset that, notwithstanding the fact that the first two parts of the first ground of appeal have been upheld, with the consequence that the finding that the General Court’s reasoning in relation to potential competition was vitiated by errors of law, it is still useful to examine the other parts of that ground of appeal in order to establish whether, irrespective of the fact that the General Court failed to apply the requisite legal criteria and failed to take into account all the relevant evidence, its interpretation of the evidence which it actually examined is vitiated by illegality and, in particular, by a possible distortion of that evidence, as the Commission claims.
109 In paragraph 201 of the judgment under appeal, the General Court examined whether there were genuine disputes between Servier and Krka and whether the Krka licence agreement appeared to have a sufficiently direct connection with the settlement of those disputes to justify its linking to the Krka settlement agreement. In paragraphs 203 and 204 of that judgment, the General Court noted the existence of disputes between Servier and Krka which had given rise (i) to the EPO decision of 27 July 2006 and (ii) to the decision of the High Court of 3 October 2006. In paragraph 206 of that judgment, the General Court stated that there were, at the time the Krka settlement and licence agreements were concluded, ‘consistent indications capable of leading the parties to believe that the 947 patent was valid’ and referred, in that regard, to paragraphs 203 and 204 of that judgment.
110 In order to assess whether the General Court distorted the decision of the High Court of 3 October 2006 and the EPO decision of 27 July 2006, the review carried out by the Court of Justice is limited to verifying that the General Court did not manifestly exceed the limits of a reasonable assessment of that evidence. The task of the Court of Justice is not to assess independently whether the Commission has discharged its burden of proof necessary to show the existence of a restriction of competition by object, but to determine whether, in finding that that was not the case, the General Court construed that evidence in a manner manifestly at odds with its wording (see, by analogy, judgment of 10 February 2011, Activision Blizzard Germany v Commission, C‑260/09 P, EU:C:2011:62, paragraph 57).
111 The Commission’s complaints alleging distortion must be examined in the light of those considerations.
(i) The decision of the High Court of 3 October 2006
112 Paragraph 204 of the judgment under appeal is worded as follows:
‘… On 1 September 2006, Krka had 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 brought by Krka on 1 September 2006. On 1 December 2006, the ongoing proceedings were discontinued as a result of the settlement reached between the parties and the interim injunction was lifted.’
113 It follows from the wording of paragraph 204 that, by referring to the denial of ‘the motion brought by Krka on 1 September 2006’, the General Court was referring to the rejection by the decision of the High Court of 3 October 2006 of Krka’s counterclaim.
114 However, that decision, which is set out in Annex B.2 to the Commission’s defence at first instance, first, states that Servier’s application for an interim injunction was granted and, second, dismisses not Krka’s counterclaim but the application that that counterclaim seeking the invalidation of the 947 patent be granted by means of a motion for summary judgment.
115 It follows that, in paragraph 208 of the judgment under appeal, the General Court distorted the clear and precise terms of the decision of the High Court of 3 October 2006, even though it faithfully referred to that decision in paragraphs 12 and 334 of that judgment.
116 On the basis of that distortion, the General Court, first of all, stated, in paragraph 206 of the judgment under appeal, that ‘there [were], at the time the [Krka] settlement and licence agreements were concluded, consistent indications capable of leading the parties to believe that the 947 patent was valid’ and, next, in paragraph 253 of that judgment, that the two events consisting of the EPO decision of 27 July 2006 and the decision of the High Court of 3 October 2006 ‘substantially altered the context in which the agreements were concluded, in particular as regards the perception that Krka, as well as [Servier], could have of the validity of the 947 patent’. Lastly, on the basis of that latter finding, the General Court held, in paragraph 260 of that judgment, that the occurrence of those two events ‘considerably limits’ the relevance of a Servier document relating to its strategy towards Krka. Furthermore, in paragraph 235 of that judgment, the General Court stated that Krka had settled with Servier not in return for the earnings obtained from the Krka licence agreement, but because Krka ‘recognised the validity of the 947 patent’, which was the ‘decisive factor’ in that regard.
117 The decision of the High Court of 3 October 2006, given its provisional nature and the preliminary procedure at the end of which that decision was adopted, in no way prejudged the substantive outcome of the dispute. The national court merely found, in reality, in accordance with the criteria for granting summary judgment, that Krka’s counterclaim was manifestly unfounded, while pointing out in that regard, in paragraph 70 of that decision, that there was ‘no doubt that Krka has shown that there is a serious issue to be tried that the sale of [Servier’s perindopril] tablets before the priority date deprives the [947] patent of novelty’, stating, however, that it was not ‘persuaded that Servier [has] no real prospects of defending [the 947] patent against that attack’.
118 By thus distorting the clear and precise terms of the decision of the High Court of 3 October 2006, the General Court vitiated paragraphs 204, 206, 235, 253 and 260 of the judgment under appeal with illegality.
(ii) The EPO decision of 27 July 2006
119 Paragraph 203 of the judgment under appeal is worded as follows:
‘In 2004, ten generic companies, including Krka, had filed opposition proceedings against the 947 patent before the EPO, seeking the revocation of that patent in its entirety on grounds of lack of novelty, lack of inventive step and insufficient disclosure of the invention. On 27 July 2006, the EPO’s Opposition Division confirmed the validity of that patent following minor amendments to Servier’s original claims. Seven companies then brought an appeal against the EPO decision of 27 July 2006. Krka withdrew from the opposition proceedings on 11 January 2007, pursuant to the settlement agreement concluded with Servier.’
120 The General Court thus gave a precise account of the content of the EPO decision of 27 July 2006.
121 However, it must be noted that the statement, in paragraph 206 of the judgment under appeal, that ‘there [were], at the time the [Krka] settlement and licence agreements were concluded, consistent indications capable of leading the parties to believe that the 947 patent was valid’ is based, at least in part, on the distortion of the decision of the High Court of 3 October 2006, on which the General Court also relied in paragraphs 253 and 260 of that judgment.
122 Furthermore, that statement by the General Court disregards several other items of evidence referred to in the decision at issue, which, according to the Commission, prove that, although the EPO decision of 27 July 2006 constituted a setback for Krka, that undertaking was far from having resigned itself to recognising the validity of the 947 patent. The decision at issue mentions, inter alia, in recitals 1687 to 1689 that Krka, which had appealed against that EPO decision, also continued the challenge to the 947 patent by bringing, on 1 September 2006, in the United Kingdom, a counterclaim against Servier seeking a declaration of invalidity of that patent. The decision of the High Court of 3 October 2006 emphasises that Krka had a ‘powerful base’ for attacking the 947 patent. The decision at issue also refers to statements by Krka’s employees in response to that decision, which contradict any sense of resignation with regard to the EPO decision of 27 July 2006 and to the fact that Krka obtained, in September 2006, the dismissal of the action for infringement of the 947 patent brought by Servier in Hungary and continued to market its generic version of perindopril on the market of that Member State.
123 It was on the basis of that material that, in recital 1690, the decision at issue made the following finding as regards Krka’s position following the EPO decision of 27 July 2006:
‘Krka’s assessment of the patent situation was certainly influenced by the Opposition Decision, and the grant of the interim injunctions against Krka and Apotex in the UK. Yet, the above strongly suggests that, from an ex ante perspective, nothing precluded a real concrete possibility for Krka to invalidate the 947 patent in full trial.’
124 It is therefore clear, on reading that material, that the decision at issue, examined as a whole, was intended to demonstrate, on the basis of a body of consistent evidence, that Krka had not resigned itself to recognising the validity of the 947 patent following the EPO decision of 27 July 2006, despite the doubts to which that decision could have given rise as regards the chances of obtaining the revocation of that patent. In paragraph 206 of the judgment under appeal, the General Court stated, without giving adequate reasons, since it did not examine all the evidence relied on in that regard in the decision at issue, that ‘there were … consistent indications capable of leading the parties to believe that the 947 patent was valid’. Thus, the General Court not only failed to take into consideration the matters referred to in paragraphs 122 and 123 of the present judgment, but also failed to explain the reasons for that omission, whereas the existence of an infringement of the competition rules can only be correctly determined if the evidence upon which the contested decision is based is considered, not in isolation, but as a whole, account being taken of the specific features of the market of the products in question (judgment of 14 July 1972, Imperial Chemical Industries v Commission, 48/69, EU:C:1972:70, paragraph 68).
125 In so doing, the General Court distorted the meaning and scope of the decision at issue in so far as it relates to the effects of the EPO decision of 27 July 2006 on Krka’s recognition of the validity of the 947 patent (see, by analogy, judgment of 11 September 2003, Belgium v Commission, C‑197/99 P, EU:C:2003:444, paragraphs 66 and 67). In addition, it infringed its obligation under Article 36 of the Statute of the Court of Justice of the European Union, applicable to the General Court by virtue of the first paragraph of Article 53 of that Statute, to state the reasons on which its judgments are based, since it failed to set out the grounds on which it based its assessment, in paragraph 206 of the judgment under appeal, in a manner sufficient to enable the persons concerned to be apprised of those grounds and the Court of Justice to have the evidence available to it to exercise its power of review on appeal (see, to that effect, judgment of 25 November 2020, Commission v GEA Group, C‑823/18 P, EU:C:2020:955, paragraph 42 and the case-law cited).
126 Therefore, in addition to the distortion of the decision of the High Court of 3 October 2006 established in paragraph 118 of the present judgment, paragraph 206 of the judgment under appeal is based on a distortion of the decision at issue and is vitiated by a failure to state reasons.
127 In the light of the foregoing, the third and fifth parts of the first ground of appeal must be upheld.
(c) The fourth part
(1) Arguments of the parties
128 By the fourth part of its first ground of appeal, the Commission criticises the General Court for having distorted, in paragraph 236 of the judgment under appeal, Krka’s estimate of EUR 10 million over a period of three years as the opportunity cost of not reaching a settlement with Servier, finding that estimate to be an indication of Krka’s recognition of the validity of the 947 patent. First, that estimate was provided in April 2013, with the result that it could not be used retroactively as evidence of Krka’s perception at the time of the conclusion of the Krka settlement and licence agreements. Second, Krka’s expected profits were one of the reasons why the Krka licence agreement constituted an inducement to reach a settlement. Third, there was no evidence on the basis of which to assert, as the General Court did in paragraph 236 of that judgment, that it was unlikely that Krka would decide to make an ‘at risk’ entry to its core markets, which were covered by the Krka licence agreement. On the contrary, recital 1675 of the decision at issue referred to serious evidence of such an intention on the part of Krka.
129 Krka submits that the case file does not reveal any obvious distortion. The Commission is seeking to make its own interpretation of the evidence prevail over that of the General Court.
(2) Findings of the Court
130 It should be noted that, by the fourth part of its first ground of appeal, the Commission, under the guise of an alleged distortion of an item of evidence, is in reality seeking to have that evidence reassessed, which does not fall within the jurisdiction of the Court of Justice in appeal proceedings.
131 The fourth part of the first ground of appeal must therefore be rejected as inadmissible.
132 In the light of all the foregoing considerations, the fourth part of the first ground of appeal must be rejected and the first to third and fifth parts of that ground must be upheld.
4. The second ground of appeal
133 By its second ground of appeal, the Commission disputes the General Court’s findings in relation to the Krka licence agreement as an inducement to Krka to accept the restrictions of competition contained in the Krka settlement agreement. That ground has eight parts.
(a) The second part
(1) Arguments of the parties
134 By the second part of its second ground of appeal, the Commission complains that the General Court held, in paragraphs 199 and 201 to 208 of the judgment under appeal, that, where there is a genuine dispute relating to a patent, the linking of a settlement agreement with a licence agreement does not constitute a strong indication of reverse payment. That formalistic approach is contrary to the case-law, in particular the judgment of 4 October 2011, Football Association Premier League and Others (C‑403/08 and C‑429/08, EU:C:2011:631, paragraph 136), which requires, in order to identify a restriction of competition by object, account to be taken of the content, objective and economic and legal context of the agreements at issue.
135 Krka submits that that line of argument is the result of a misreading of the judgment under appeal. The General Court, in paragraphs 201 to 268 and 279 to 298 of that judgment, relied not on the form of the Krka settlement and licence agreements but on their content, objectives and economic and legal context. Furthermore, the Commission’s line of argument is refuted by point 204 of the Communication from the Commission entitled ‘Guidelines on the application of Article [101 TFEU] to technology transfer agreements’ (OJ 2004 C 101, p. 2). It is clear, furthermore, from points 234 and 236 of the Communication from the Commission entitled ‘Guidelines on the application of Article 101 of the Treaty on the Functioning of the European Union to technology transfer agreements’ (OJ 2014 C 89, p. 3), that that institution encourages licence agreements as a means of settling patent disputes and does not regard a licence and non-assertion agreement as being, in itself, a restriction of competition.
(2) Findings of the Court
136 Since the second part of the second ground of appeal relates to the criteria in the light of which the General Court had to assess the existence of a restriction of competition by object, it is appropriate to examine it first.
137 As regards the Commission’s criticisms of paragraph 199 of the judgment under appeal, it should be borne in mind that, in that paragraph, the General Court held that, where there is a genuine dispute relating to a patent and a licence agreement directly connected with the settlement of that dispute, an agreement settling that dispute, containing competition-restricting clauses such as non-challenge and non-marketing clauses, linked to a licence agreement concerning that patent, can be classified as a restriction of competition by object only if the Commission can demonstrate that that licence agreement does not constitute a transaction concluded at arm’s length and thus masks a reverse payment.
138 Although the infringement of Article 101 TFEU found by the decision at issue consisted in Servier and Krka dividing the markets into two areas, only one of which falls within the scope of that infringement, the General Court stated, in essence, in paragraphs 199 to 201 of the judgment under appeal, that it would confine itself to examining whether the Krka licence agreement could be justified by the Krka settlement agreement or whether, on the contrary, that licence agreement actually masked a reverse payment inducing Krka to agree to the non-marketing and non-challenge clauses provided for in that settlement agreement. That reasoning disregards (i) the fact that the Krka licence agreement concerns markets which do not fall within the scope of the infringement of Article 101 TFEU and (ii) the nature of that infringement, consisting not in a mere patent dispute settlement agreement in return for a reverse payment, but in an agreement to share markets.
139 Thus, paragraphs 199 to 201 of the judgment under appeal lays down criteria for assessing the existence of a restriction of competition by object which are incompatible with those referred to in paragraphs 66 to 72 of the present judgment and which are based on a misinterpretation of Article 101(1) TFEU. It must be stated that the differences between those legal criteria applied by the General Court and those referred to in paragraphs 66 to 72 of the present judgment are not merely semantic but lead to substantially different results.
140 In addition, it must be borne in mind that, in paragraph 208 of the judgment under appeal, the General Court held that, ‘having regard to the scope of the terms of the [Krka settlement and licence agreements] and the context in which those agreements were signed, it must be held that the linking of those two agreements was justified and therefore does not constitute a strong indication of the existence of a reverse payment from Servier to Krka giving rise to the licence agreement’, while referring the reader to paragraph 184 of that judgment.
141 It is true that the fact that undertakings conclude a patent dispute settlement agreement linked to a licence agreement concerning that patent does not, in itself, constitute conduct restricting competition. Nevertheless, such agreements may, depending on both their content and their economic context, serve as an instrument for influencing the commercial conduct of the undertakings in question so as to restrict or distort competition on the market on which they carry on business (see, by analogy, judgment of 17 November 1987, British American Tobacco and Reynolds Industries v Commission, 142/84 and 156/84, EU:C:1987:490, paragraph 37).
142 In order to be caught by the prohibition laid down in Article 101(1) TFEU, a collusive practice must fulfil certain conditions depending not on the legal nature of that practice or on the legal instruments intended to implement it, but on its relationship with competition. Since the application of that provision is based on an assessment of the economic impacts of the practice in question, that provision cannot be interpreted as establishing any kind of advance judgment with regard to a category of agreements determined by their legal nature, since every agreement must be assessed in the light of its specific content and economic context and, in particular, in the light of the situation on the market concerned (see, to that effect, judgments of 30 June 1966, LTM, 56/65, EU:C:1966:38, p. 248, and of 17 November 1987, British American Tobacco and Reynolds Industries v Commission, 142/84 and 156/84, EU:C:1987:490, paragraph 40). The effectiveness of EU competition law would be seriously jeopardised if the parties to anticompetitive agreements could evade the application of Article 101 TFEU simply by giving such agreements particular forms (today’s judgment, Commission v Servier and Others, C‑176/19 P, paragraph 179).
143 Apart from the fact that, in the present case, the Krka settlement and licence agreements relate to separate markets and that the markets covered by the Krka licence agreement do not fall within the scope of the infringement of Article 101 TFEU, it must be pointed out that, while the conclusion by the holder of a patent of a settlement agreement with a manufacturer of generic medicines accused of infringement does constitute an expression of the intellectual property right of that holder, which permits that holder, inter alia, to oppose any infringement, the fact remains that that patent does not permit its holder to enter into contracts that are contrary to Article 101 TFEU (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 97).
144 Moreover, characterisation as a restriction of competition by object does not depend either on the form of the contracts or other legal instruments intended to implement such a collusive practice or on the subjective perception that the parties may have of the outcome of the dispute between them as to the validity of a patent.
145 Furthermore, as noted in paragraph 75 of the present judgment, the fact that undertakings the conduct of which could be regarded as a restriction of competition by object acted without having an intention to prevent, restrict or distort competition and the fact that they pursued certain legitimate objectives are not decisive for the purposes of the application of Article 101(1) TFEU (see. to that effect, judgment of 21 December 2023, European Superleague Company, C‑333/21, EU:C:2023:1011, paragraph 167 and the case-law cited). Only the assessment of the degree of economic harm of that practice to the proper functioning of competition in the market concerned is relevant. That assessment must be based on objective considerations, where necessary as a result of a detailed analysis of that practice, its objectives and the economic and legal context of which it forms part (see, to that effect, judgments of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraphs 84 and 85, and of 25 March 2021, Lundbeck v Commission, C‑591/16 P, EU:C:2021:243, paragraph 131).
146 That is why, in order to determine whether a collusive practice may be classified as a restriction of competition by object, it is necessary to examine its content, its origin and its legal and economic context, in particular the specific characteristics of the market in which its effects will actually occur. The fact that the terms of an agreement intended to implement that practice do not reveal an anticompetitive object is not, in itself, decisive (see, 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, paragraphs 23 to 25, and of 28 March 1984, Compagnie royale asturienne des mines and Rheinzink v Commission, 29/83 and 30/83, EU:C:1984:130, paragraph 26).
147 However, instead of carrying out such an assessment of the collusive practice implemented by means of the Krka settlement and licence agreements in the light of its specific content and its economic impacts, the General Court, in paragraphs 179 to 199 of the judgment under appeal, developed criteria to identify, in a general and abstract manner, the conditions under which a combination of a patent dispute settlement agreement and a licence agreement relating to that patent may, in view of the legal characteristics of those agreements alone, be classified as a restriction of competition by object within the meaning of Article 101(1) TFEU. Applying those criteria to the Krka settlement and licence agreements, the General Court focused its analysis on the form and legal characteristics of those agreements, rather than examining their actual relationship with competition. It thus disregarded the principles governing the application and interpretation of Article 101(1) TFEU referred to in paragraphs 142 and 146 of the present judgment and vitiated paragraphs 179 to 208 of the judgment under appeal with illegality.
148 Accordingly, the second part of the second ground of appeal must be upheld.
(b) The first, third and fourth parts
(1) Arguments of the parties
149 By the first part of its second ground of appeal, the Commission complains that the General Court’s reasoning is contradictory. In paragraph 265 of the judgment under appeal, the General Court recognised that the Krka licence agreement was a condition for that undertaking to agree to the non-compete and non-challenge clauses, which, as the General Court pointed out in paragraph 152 of that judgment, are ‘inherently restrictive’. However, it refused to infer from this that that licence agreement induced Krka to settle the disputes relating to the 947 patent, by relying on two erroneous grounds, namely (i) the parties’ perception of the validity of that patent and (ii) the fact that that licence agreement was concluded at arm’s length. The General Court, in relying on the fiction of a settlement based on the merits of the 947 patent and of a licence for that patent concluded at arm’s length, therefore did not, for the purposes of the legal characterisation of those agreements as a restriction of competition by object, attach sufficient importance to the objective pursued by those agreements. The General Court also overlooked statements by which Krka acknowledged that it had ‘sacrificed’ its entry into Servier’s core markets in order to be able to remain on its seven core markets.
150 By the third part, the Commission criticises the grounds set out in paragraphs 173, 199, 211 to 220 and 225 of the judgment under appeal, by which the General Court considered that the Krka licence agreement had been concluded at arm’s length. That consideration is in fact irrelevant, since the decisive factor is that the Krka settlement and licence agreements were based not on each party’s assessment of the validity of the 947 patent, but on their common objective of sharing the markets, at the expense of consumers, by means of the Krka agreements, taken as a whole.
151 By the fourth part, the Commission complains that, in paragraphs 173 and 213 to 218 of the judgment under appeal, the General Court limited its analysis of the inducive nature of the Krka licence agreement to the question whether the royalty rate provided for in that agreement was abnormally low. The General Court should have analysed that agreement, together with the Krka settlement agreement, and examined the effect of those agreements on the parties’ incentives to compete with each other and the profit – estimated at over EUR 25 million – which Servier forewent by concluding that licence agreement.
152 As regards the first part, Krka submits that the Commission’s line of argument is the result of a misreading of the judgment under appeal. The General Court found not that Krka had made the Krka licence agreement a condition of its agreeing to the non-marketing and non-challenge clauses, but that the Commission had not established ‘the existence of a reverse payment resulting from the granting of a licence’ and that none of the other factors relied on by the Commission could call that conclusion into question, as is clear from paragraphs 220 and 222 of that judgment. Furthermore, the General Court cannot be criticised for failing to take into account all the facts and evidence, since it is clear from paragraph 265 of that judgment that the General Court took into account the evidence referred to in recitals 913 and 1746 to 1748 of the decision at issue.
153 Krka submits that the third and fourth parts are inadmissible because they seek to challenge factual assessments. Moreover, the General Court correctly noted that, in the absence of an agreement with Servier, Krka would not have been able to market its perindopril composed of the alpha crystalline form of erbumine that was covered by the 947 patent on any market whatsoever.
154 Krka states that the fourth part is based on a misreading of the judgment under appeal. The General Court did in fact carry out an overall assessment of the evidence in order to determine whether there was a transfer of value. Acting in its absolute discretion, it found, inter alia, that the Krka licence agreement had not induced Krka to refrain from competing with Servier.
(2) Findings of the Court
155 It should be noted at the outset that the third and fourth parts of the second ground of appeal are admissible because, in essence, they do not seek to call into question factual findings but the criterion applied by the General Court for the purposes of assessing the inducement for Krka to settle the disputes relating to the 947 patent by the Krka settlement agreement.
156 By the first, third and fourth parts of the second ground of appeal, which it is appropriate to examine together, the Commission essentially criticises the General Court for having held that the Krka licence agreement had not induced that undertaking to conclude the Krka settlement agreement. The Commission claims that the General Court relied on a limited and reductive analysis of the content, objectives and economic context of the infringement resulting from those agreements.
157 As regards the first part of the second ground of appeal, it should be noted that, as the Commission claims, paragraph 265 of the judgment under appeal is contradictory. It is apparent from that paragraph that the conclusion of the Krka licence agreement was the ‘condition’ or, in other words, the inducement offered to Krka for it to agree to the non-marketing and non-challenge clauses contained in the Krka settlement agreement. It follows that, irrespective of whether the level of the royalty provided for by that licence agreement was appropriate in the light of the market conditions, it was the access to its core markets without risk of patent infringement which motivated Krka to refrain from selling its perindopril on Servier’s core markets. Therefore, the General Court could not, without contradicting itself, assert, in that paragraph, that the Commission had not established that the royalty rate ‘was not chosen on the basis of commercial considerations, but rather in order to induce Krka to accept [those] clauses’.
158 In the light of the characteristics of the infringement found by the Commission which are recalled in paragraphs 44 and 45 of the present judgment, the General Court was required, in order to rule on those of Krka’s arguments, invoked in the context of the third plea at first instance, that relate to the existence of a restriction of competition by object, to apply the criteria recalled in paragraphs 61, 63 to 66, 71, 72, 74 and 75 of the present judgment to the unlawful practice resulting from the Krka settlement and licence agreements. It was thus incumbent on the General Court to assess the degree of economic harm of that practice, by carrying out a detailed analysis of its characteristics, its objectives and the economic and legal context of which it forms part.
159 As has been noted in paragraph 137 of the present judgment, the General Court found, in essence, in paragraph 199 of the judgment under appeal, that, where there is a genuine dispute, the linking of a licence agreement to an agreement settling that dispute does not constitute a strong indication of the existence of a reverse payment, and that it is for the Commission to ‘demonstrate … that the licence agreement does not constitute a transaction concluded at arm’s length’, with the effect that that institution could not find that there was a restriction of competition by object in the present case.
160 It follows that, by focusing its analysis on the Krka licence agreement, whereas it should have examined the infringement found by the Commission, taken as a whole, as resulting from the combination of that agreement and the Krka settlement agreement, the General Court erred in law in the interpretation and application of Article 101 TFEU. That error led the General Court to restrict the scope of its analysis of the characterisation of a restriction of competition by object to the question whether the Commission had succeeded in establishing that the royalty rate provided for in the Krka licence agreement was abnormally low.
161 By merely finding, for the reasons set out in paragraphs 209 to 220 of the judgment under appeal, that the Commission had not established that Servier had granted Krka a licence at an abnormally low price, the General Court ignored the essential elements of the infringement referred to in paragraphs 44 and 45 of the present judgment and failed to examine, in the light of the parties’ reciprocal commitments and incentives, whether the Krka licence agreement might have induced that undertaking to refrain from competing with Servier.
162 It follows that, by relying on the fact that the royalty rate provided for by the Krka licence agreement was not abnormally low, without analysing in the light of the economic and legal context which gave rise to a sharing of markets resulting from that agreement in conjunction with the Krka settlement agreement whether the transfer of value resulting from the fact that the Krka licence agreement allowed that undertaking to market its products on its core markets without risk of infringement was sufficiently large to actually induce Krka not to enter Servier’s core markets, the General Court erred in law in the interpretation and application of Article 101(1) TFEU and vitiated the lawfulness of the grounds set out in paragraphs 199, 209 to 220 and 265 of the judgment under appeal.
163 The first, third and fourth parts of the second ground of appeal must, therefore, be upheld.
(c) The fifth to eighth parts
(1) Arguments of the parties
164 By the fifth part of its second ground of appeal, the Commission submits that the grounds set out in paragraphs 211 to 220 of the judgment under appeal are based on the distortion of several items of evidence. First, contrary to what is stated in paragraphs 214 and 216 of that judgment, the Commission did not consider that the royalty rate provided for in the Krka licence agreement was much lower than Servier’s operating profit, but that the loss suffered by Servier constituted a net transfer of value to Krka. Second, in paragraph 215 of that judgment, the General Court distorted the fact that that royalty represented a small proportion of Krka’s profits from the markets covered by that licence agreement. Third, contrary to what is stated in paragraph 217 of that judgment, the fact that the licence granted to Krka is not exclusive does not prevent it from constituting a sufficient inducement, since it offered that undertaking, on its core markets, the prospect of constituting a de facto duopoly with Servier.
165 By the sixth part, the Commission criticises the General Court for having held, in paragraphs 228 to 234 of the judgment under appeal, that it would be paradoxical to consider that the broader the terms of a patent licence, the greater the incentive to conclude a settlement agreement containing competition-restricting clauses, and the easier it would be to characterise those agreements as a restriction of competition by object. That assertion is based on a misreading of the decision at issue, from which it is apparent that the Krka licence agreement served to induce that undertaking to refrain from entering Servier’s core markets, which were not covered by the Krka licence agreement.
166 By the seventh part, the Commission criticises paragraph 233 of the judgment under appeal in so far as it states that the decision at issue obliges the patent holder to grant a licence over the entire territory covered by a settlement agreement. The decision at issue does not lay down such an obligation.
167 By the eighth part, the Commission criticises the General Court for having held, in paragraph 234 of the judgment under appeal, that, in order for an agreement to be regarded as an ‘inducement’ for a party, that agreement must compensate that party for the loss resulting from the clauses prohibiting it from entering certain markets. That assessment, first, is contrary to the case-law, which merely requires that a transfer of value be sufficiently high to induce a manufacturer of generic medicines to refrain from entering the market and, second, distorts the evidence referred to in footnote 2348 to the decision at issue, on the basis of which the Commission considered that the profits that Krka expected to make on its core markets as a result of the Krka licence agreement were sufficiently high to persuade it to refrain from entering Servier’s core markets.
168 Krka claims that the fifth part is inadmissible, because it seeks to challenge factual assessments and does not precisely identify the distortions and errors alleged. On the substance, none of the distortions relied upon is well founded.
169 According to Krka, the sixth and seventh parts are unfounded and in fact confirm the judgment under appeal. In paragraph 70 of its appeal, the Commission concedes that ‘the patent holder has several, lawful options, including that it could reach a settlement based on each party’s assessment that the disputed patent is valid and the [generic] product infringes that patent (without being obliged to grant a licence) or, alternatively, the patent holder could enter into a settlement agreement with the same geographic scope as the licence’. The option regarded as lawful by the Commission corresponds to the facts of the present case as found by the General Court.
170 In Krka’s view, it is clear from paragraphs 228 to 235 of the judgment under appeal that the eighth part is manifestly unfounded.
(2) Findings of the Court
171 By the fifth part of its second ground of appeal, the Commission submits that the General Court distorted several items of evidence in its assessments made, in paragraphs 211 to 220 of the judgment under appeal, on the level at which the royalty rate of the Krka licence agreement was set, in order to determine whether that agreement could have induced that undertaking to refrain from entering Servier’s core markets. The Court of Justice has already held, in paragraphs 160 to 162 of the present judgment, that that reasoning of the General Court is based on the application of a legally incorrect criterion, relating to the question whether the Krka licence agreement had been concluded at arm’s length. Since paragraphs 211 to 220 of the judgment under appeal are vitiated by illegality as a result of that error of law, it is not necessary to rule on that fifth part.
172 By the sixth to eighth parts of its second ground of appeal, the Commission criticises the findings made in paragraphs 228 to 234 of the judgment under appeal, by which the General Court rejected the Commission’s reasoning that the Krka licence agreement constituted an inducement to postpone its entry into Servier’s core markets, on the ground, in essence, that the scope of the non-marketing and non-challenge clauses set out in the Krka settlement agreement was broader than that of the Krka licence agreement. Those findings of the General Court are based on the premiss that a licence agreement concluded at arm’s length therefore satisfies the test laid down by the General Court in paragraph 199 of that judgment and cannot therefore constitute an inducement to conclude a dispute settlement agreement relating to that patent containing competition-restricting clauses. Since that criterion is incorrect in law, the findings made in paragraphs 230 to 234 of that judgment are based on a premiss which is itself incorrect and are therefore vitiated by illegality. Consequently, the sixth to eighth parts of that ground of appeal must be upheld.
173 In the light of the foregoing, the second ground of appeal must be upheld.
5. The third ground of appeal
174 By its third ground of appeal, the Commission claims that the General Court erred in law in the application of the concept of a restriction of competition by object, within the meaning of Article 101(1) TFEU. That ground of appeal consists of six parts.
(a) The first part
(1) Arguments of the parties
175 By the first part of its third ground of appeal, the Commission criticises paragraphs 240 to 242 of the judgment under appeal, in which the General Court held that a market-sharing agreement presupposes a ‘hermetic’ division of the markets between the parties. That assessment is contrary to Article 101(1)(c) TFEU, which, as is apparent from the judgment of 27 July 2005, Brasserie nationale and Others v Commission (T‑49/02 to T‑51/02, EU:T:2005:298, paragraph 156), does not impose any condition of that nature for classification as a market-sharing agreement or, as follows, in particular, from the judgment of 20 January 2016, Toshiba Corporation v Commission (C‑373/14 P, EU:C:2016:26, paragraph 28), for classification of that type of agreement as a restriction of competition by object.
176 According to Krka, that line of argument is based on a misreading of the judgment under appeal. In paragraphs 239 to 250 of that judgment, the General Court did not require a ‘hermetic’ division of the markets, but rather found that the purpose of the Krka agreements was not a sharing of markets. In relation to Krka’s core markets, the General Court found that the EPO decision of 27 July 2006 allowed Servier to exclude Krka’s perindopril. Not only did the Krka licence agreement not have anticompetitive effects, it had, moreover, a procompetitive effect. In relation to Servier’s core markets, the Commission explicitly admitted that the patent situation prevented Krka from marketing its perindopril. Krka held no marketing authorisations for a non-infringing version of perindopril. Krka was therefore excluded from Servier’s core markets not on account of the Krka settlement agreement but due to the combined effect of the EPO decision of 27 July 2006 and the absence of any marketing authorisations for a non-infringing version of perindopril.
(2) Findings of the Court
177 After concluding, in essence, in paragraph 221 of the judgment under appeal, that the Commission could not characterise the Krka settlement and licence agreements as a restriction of competition by object, the General Court held that that conclusion could not be called into question by any of the other factors relied on in the decision at issue. Thus, for the reasons set out in paragraphs 239 to 250 of that judgment, the General Court held that the Commission was not justified in finding that those agreements constituted a sharing of markets between Servier and Krka. In particular, in paragraph 241 of that judgment, it found that Servier was not excluded from Krka’s core markets. In paragraph 242 of that judgment, the General Court inferred from that finding that ‘there was no part of the market which, under the [Krka] settlement and licence agreements, was reserved for Krka’ and that, therefore, it could not ‘be concluded that there was market sharing – in the sense of a hermetic division between the parties to the agreement[s] – of that part of the internal market’.
178 However, the fact that an agreement which shares markets is not ‘hermetic’ by no means precludes its being classified as a restriction of competition by object. Article 101(1)(c) TFEU expressly prohibits agreements which share markets. It follows from the case-law referred to in paragraph 64 of the present judgment that horizontal cooperation agreements between undertakings concerning the sharing of markets are, in view of their particularly serious nature, classified as restrictive of competition by object (today’s judgment, Commission v Servier and Others, C‑176/19 P, paragraph 216).
179 In that regard, Article 101(1)(c) TFEU does not contain any specific condition providing that the prohibition which it lays down is to be limited solely to agreements which establish a ‘hermetic’ division between those markets, by means, for example, of provisions reserving access to some of those markets to one of those undertakings, to the exclusion of the other, or prohibiting exports from one market to another. Thus, in the absence of any specific provision in that regard, there is no need to distinguish between market-sharing agreements on the basis of a condition which Article 101(1) TFEU does not lay down and which no consideration relating to the purpose or general scheme of that provision makes it possible to envisage.
180 Moreover, the General Court’s interpretation would amount to allowing agreements consisting in sharing markets to avoid being characterised as restrictions of competition by object, in particular by reserving certain markets to one undertaking in exchange for the grant by that undertaking of a patent licence to another undertaking operating at the same level of the production or distribution chain, thus allowing the second undertaking to enter other markets without risk of infringement, which would reduce the full effectiveness of the prohibition laid down in Article 101(1)(c) TFEU, and would seriously undermine the implementation of EU competition law, given the clearly anticompetitive nature of such agreements.
181 Accordingly, in holding, in paragraph 242 of the judgment under appeal, that, since the Krka settlement and licence agreements had not reserved a part of the market for Krka, ‘it therefore cannot be concluded that there was market sharing – in the sense of a hermetic division between the parties to [those agreements] – of [a] part of the internal market’, the General Court relied on a misinterpretation of Article 101(1) TFEU and vitiated paragraph 242 of that judgment with illegality.
182 Consequently, the first part of the third ground of appeal must be upheld.
(b) The second part
(1) Arguments of the parties
183 By the second part of its third ground of appeal, the Commission criticises paragraph 248 of the judgment under appeal, according to which a contractual framework based on the parties’ recognition of the validity of the patent concerned cannot be classified as a market exclusion agreement. The General Court distorted the clear sense of the evidence relating to the parties’ perception of the validity of the 947 patent. Even if the Krka settlement agreement was based on that recognition, that agreement could not escape the prohibition laid down in Article 101(1) TFEU, since the object of that agreement was to divide the market.
184 Krka disputes the admissibility of that second part. The Commission does not precisely indicate the evidence that was distorted, or demonstrate the errors of appraisal which, in its view, led to that distortion. The complaint alleging an error in law is, for its part, unfounded, because it is based on the incorrect premiss that there was a market-sharing agreement.
(2) Findings of the Court
185 Contrary to what Krka claims, the Commission indicated the evidence it alleges has been distorted, by referring precisely, in a footnote, to the evidence to which the fourth part of its first ground of appeal relates. The second part of the third ground of appeal is therefore admissible.
186 In paragraph 248 of the judgment under appeal, the General Court held that, ‘since it has not been shown that there was an inducement …, the non-marketing and non-challenge clauses must be regarded as arising from a legitimate patent dispute settlement agreement which is linked to a licence agreement’ and that ‘such a contractual framework, based on the recognition of the validity of the patent, cannot, therefore, be classified as a market exclusion agreement’.
187 It must be held, in accordance with what has been held in paragraphs 69 and 94 of the present judgment, that, although the recognition of the validity of a patent which is the subject of a dispute between two parties may constitute a relevant factor in assessing whether, on the same market, the restrictions of competition brought about by a settlement agreement in that dispute may be mitigated or even neutralised by the conclusion, between those parties, of an agreement licensing that patent, that recognition is not, in itself, a decisive, or even relevant, factor in determining whether a collusive practice such as that attributed, by the decision at issue, to Servier and Krka, consisting of market sharing by means of a patent dispute settlement agreement which relates, inter alia, to markets covered by the geographic scope of the infringement, and of a licence agreement for that patent relating to markets which are not covered by it, may be classified as a restriction of competition by object.
188 It follows from the considerations set out in paragraphs 69, 94, 141 to 147 and 187 of the present judgment that, by relying (i) on Krka’s recognition of the 947 patent even though that factor is not, in itself, decisive and (ii) on the content and form of the Krka settlement and licence agreements rather than on the specific analysis of their harmfulness to competition, in the light of the context of which they form part, in order to invalidate the characterisation of those agreements as a restriction of competition by object, the General Court erred in law.
189 It is in fact true that a patent dispute settlement agreement and a licence agreement for that patent may be concluded, with a legitimate aim and entirely lawfully, on the basis of the parties’ recognition of the validity of that patent, in the absence of any other circumstance constituting an infringement of Article 101 TFEU. However, the fact that such agreements pursue a legitimate objective is not such as to exclude them from the application of Article 101 TFEU if it is established that they also have the aim of sharing markets or restricting competition in other ways (see, to that effect, judgments of 30 January 1985, BAT Cigaretten-Fabriken v Commission, 35/83, EU:C:1985:32, paragraph 33, and of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraph 70).
190 Therefore, the second part of the third ground of appeal must be upheld.
(c) The third part
(1) Arguments of the parties
191 By the third part of its third ground of appeal, the Commission submits that, in paragraphs 223 and 224 of the judgment under appeal, the General Court distorted the terms of the Krka licence agreement. The General Court stated that the possible establishment of a de facto duopoly in the seven Member States covered by that agreement – Krka’s core markets – was not the result of the terms of that agreement, but of subsequent choices made individually by Servier and Krka. That assertion is contradicted by Article 2(2) of that agreement, according to which Servier undertook not to authorise a third operator to use the 947 patent on those seven national markets.
192 Krka submits that it is clearly apparent from the decision at issue that the Commission’s complaints were directed not against the fact that Krka was the sole beneficiary of a licence for the 947 patent, but against the advantage that that licence gave to Krka. In paragraph 223 of the judgment under appeal, the General Court, correctly, rejected that complaint, finding that the ‘advantageous duopoly between Servier and Krka’ did not result ‘from [the Krka licence agreement] itself, but from the choices made by Servier and Krka after that agreement’. It follows that the General Court was correct to find that the Commission had failed to establish that Krka had been induced, by means of that licence agreement, to conclude the Krka settlement agreement and, as a result, that the characterisation as a restriction of competition by object could not be upheld.
(2) Findings of the Court
193 In paragraph 223 of the judgment under appeal, the General Court held that, even if the Krka licence agreement allowed the implementation of an ‘advantageous duopoly’ between Servier and Krka, ‘that duopoly did not result from the agreement itself, but from the choices made by Servier and Krka after that agreement, namely, Servier’s choice not to grant a licence to another generic company or to sell its own generic version of perindopril at a low price … and Krka’s choice not to adopt an aggressive pricing policy’.
194 In that regard, it should be noted that Article 2 of the Krka licence agreement, which is referred to in paragraph 20 of the judgment under appeal and which is set out in Annex B.3 to the Commission’s defence in Case T‑684/14, is worded as follows:
‘SERVIER hereby grants to KRKA the exclusive, irrevocable [licence] on the 947 patent and KRKA hereby accepts from SERVIER such licence to use, manufacture, sell, offer for sale, promote and import KRKA Products which contain crystalline form alpha of perindopril tertbutylamine salt in the Territory during the term of this Agreement.
Notwithstanding the above, SERVIER shall be entitled directly or through one of its Affiliates or through solely one third party per country, to use the 947 patent to do any of the above stated operations in the Territory.
KRKA is not allowed to grant [sublicences], other than to KRKA’s affiliates, without a prior written consent of SERVIER.’
195 It is thus apparent from those clear and precise terms that Servier granted Krka, on an exclusive and irrevocable basis, the licence to the 947 patent, subject to Servier’s right to use that patent ‘directly or through one of its Affiliates or through solely one third party per country’. Although the existence of that reservation may help to explain the cautious language used by the Commission, which merely referred, inter alia in recitals 1728, 1734 and 1742 of the decision at issue, to a ‘de facto’ duopoly on Krka’s core markets, the fact remains that the wording of that reservation, read in the light of the exclusive and irrevocable nature of the licence granted to Krka, cannot be interpreted as allowing Servier to grant a licence to that patent to another manufacturer of generic medicines who, while acting independently of Servier, could compete with Krka. Thus, by stating, in paragraph 223 of the judgment under appeal, that a duopoly between Servier and Krka resulted not from the provisions of the Krka licence agreement but from the subsequent choice made by Servier ‘not to grant a licence to another generic company’, the General Court interpreted that agreement in a manner incompatible with its wording. By distorting the sense of that agreement, the General Court vitiated paragraph 223 of that judgment with illegality.
196 In those circumstances, the third part of the third ground of appeal must be upheld.
(d) The fourth part
(1) Arguments of the parties
197 By the fourth part of its third ground of appeal, the Commission submits that the General Court erred in law in finding, in paragraphs 225 and 226 of the judgment under appeal, that the decision at issue could not rely on the establishment of a duopoly between Servier and Krka in order to find the existence of a restriction of competition by object without analysing the potential effects of the Krka settlement and licence agreements. In the Commission’s view, the object of those agreements was to change appreciably the structure of Servier’s core markets by granting Krka a licence in return for the latter’s undertaking not to enter those markets. Consequently, the examination of their effects was not necessary and was undertaken in the decision at issue only for the sake of completeness.
198 Krka counters that that line of argument is the result of a misreading of the judgment under appeal. The General Court, acting in its absolute discretion, found that the factors on the basis of which the Commission alleged that a de facto duopoly was possible were not objectively foreseeable at the time the Krka settlement and licence agreements were concluded, and were merely hypothetical.
(2) Findings of the Court
199 It should be borne in mind that, as follows from the case-law cited in paragraph 63 of the present judgment, the concept of restriction of competition by object can be applied only to certain agreements 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.
200 In order to determine whether an agreement between undertakings reveals such a degree of harm, regard must be had to the content of its provisions, its objectives and the economic and legal context of which it forms a part. When determining that context, it is also necessary to take into consideration the nature of the goods or services affected, as well as the real conditions of the functioning and structure of the market or markets in question (judgment of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraph 53).
201 However, as has been pointed out in paragraphs 60 and 61 of the present judgment, and as the Commission rightly points out, as regards practices classified as restrictions of competition by object, there is no need to investigate or, a fortiori, to demonstrate their effects on competition. Experience shows that certain behaviour is in itself likely to have negative consequences on markets (see, to that effect, judgments of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraph 51, and of 21 December 2023, European Superleague Company, C‑333/21, EU:C:2023:1011, paragraph 162). In addition, it is apparent from the case-law referred to in paragraph 64 of the present judgment that agreements which aim to share markets have, in themselves, an object restrictive of competition and fall within a category of agreements expressly prohibited by Article 101(1) TFEU, and that that prohibition cannot be called into question by an analysis of the economic context of the anticompetitive conduct concerned.
202 Therefore, as the General Court itself noted in paragraphs 124 and 225 of the judgment under appeal, it is apparent from the case-law of the Court of Justice referred to in paragraphs 199 to 201 of the present judgment 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. The General Court also held in paragraph 225 of that judgment, referring exclusively to the Opinion of Advocate General Wahl in ING Pensii (C‑172/14, EU:C:2015:272), 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. In paragraph 226 of that judgment, it therefore stated that ‘the alleged potential effects in question, that is to say, the duopoly alleged by the Commission, are based on hypothetical circumstances which were therefore not objectively foreseeable at the time of the conclusion of the [Krka] settlement and licence agreements’.
203 It must be stated that paragraph 225 of the judgment under appeal is vitiated by an internal contradiction, since it indicates both that the effects of a restriction of competition by object do not have to be assessed in order to establish the existence of that restriction and that such effects cannot be ignored when examining the restrictive object of an agreement. Those two statements are incompatible.
204 Moreover, paragraph 225 of the judgment under appeal contains an error of law in so far as the General Court observed that the Commission and the Courts of the European Union cannot, when examining whether an agreement restricts competition by object, completely ignore its potential effects. That observation, which is not based on any judgment of the Court of Justice, directly contradicts the case-law referred to in paragraphs 199 to 201 of the present judgment, according to which, as regards practices characterised as restrictions of competition by object, there is no need to investigate nor a fortiori to demonstrate their effects on competition.
205 That incorrect assessment confuses, moreover, the exercise of ascertaining whether conduct is capable, by its very nature, of systematically harming competition by reason of its particular characteristics and whether it therefore reveals a sufficient degree of harm to competition to be classified as a restriction of competition by object with that of analysing the actual or potential effects of specific conduct in a particular case, which is relevant solely for the assessment of the existence of a possible restriction of competition by effect.
206 In order to determine whether conduct presents such a degree of harm, it is not necessary to examine, nor, a fortiori, to prove, the effects of that conduct on competition, be they actual or potential, or negative or positive (see. to that effect, judgment of 21 December 2023, European Superleague Company, C‑333/21, EU:C:2023:1011, paragraphs 159, 162 and 166 and the case-law cited).
207 In the light of the case-law referred to in paragraphs 199 to 201 and 206 of the present judgment, which precludes the effects of an agreement or a practice from being taken into account, the General Court erred in law, in paragraph 226 of the judgment under appeal, by introducing, in its reasoning relating to the restriction of competition by object found in the decision at issue and based on the fact that the Krka settlement and licence agreements gave rise to a sharing of geographic markets in the European Union, considerations relating to the allegedly hypothetical nature of the potential effects of those agreements, considerations which it was not for the Commission to take into account in that regard.
208 The fourth part of the third ground of appeal must therefore be upheld.
(e) The fifth part
(1) Arguments of the parties
209 By the fifth part of its third ground of appeal, the Commission criticises the General Court for having, in paragraph 259 of the judgment under appeal, rejected Lupin’s statement referred to in recital 1730 of the decision at issue, according to which it ‘would seem the rationale for [the Krka settlement agreement] from Servier’s view is that it protects the key markets where high level substitution and/or [international non-proprietary name] prescribing is prevalent’, on the ground that that statement does not prove Servier’s intention to adopt market-sharing or market exclusion agreements with Krka. According to the Commission, that statement was not intended to prove Servier’s intention, but to corroborate a subsequent statement by Krka, which demonstrated that the Krka settlement and licence agreements had made a form of market sharing possible, thereby helping to establish the anticompetitive object of those agreements.
210 Krka disputes that line of argument. In paragraph 259 of the judgment under appeal, the General Court, according to Krka, found that the existence of a market-sharing agreement could not be established from that statement by Lupin. Krka notes that, in the decision at issue, the Commission referred to that statement not in a section concerning the object of the Krka settlement and licence agreements, but in a section concerning Servier’s interest in Krka’s commitments contained in the Krka settlement agreement.
(2) Findings of the Court
211 It should be recalled that it is apparent from Article 256(1) TFEU and the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union that an appeal is limited to points of law and that the General Court therefore has sole jurisdiction to find and appraise the relevant facts and evidence. The assessment of the facts and evidence does not, save where the facts and evidence are distorted, constitute a point of law which is subject, as such, to review by the Court of Justice on appeal (judgment of 16 February 2023, Commission v Italy, C‑623/20 P, EU:C:2023:97, paragraph 116 and the case-law cited).
212 In the present case, it must be stated that the Commission does not allege distortion, with the result that the fifth part of the third ground of appeal is inadmissible.
(f) The sixth part
(1) Arguments of the parties
213 By the sixth part of its third ground of appeal, the Commission asserts that, in paragraphs 130, 182 and 194 of the judgment under appeal, the General Court misinterpreted Commission Regulation (EC) No 772/2004 of 27 April 2004 on the application of Article [101](3) TFEU] to categories of technology transfer agreements (OJ 2004 L 123, p. 11), and the Commission Notice entitled ‘Guidelines on the application of Article [101 TFEU] to technology transfer agreements’ (OJ 2004 C 101, p. 2).
214 Krka submits that the General Court found that the Krka settlement and licence agreements did not constitute a restriction of competition by object in reliance on an overall analysis of the terms of those agreements and of the context in which they were concluded. In its view, the Commission ignores the fact that Krka’s perindopril could not be marketed on Servier’s core markets not on account of those agreements but as result of the 947 patent.
(2) Findings of the Court
215 It should be noted that paragraph 130 of the judgment under appeal, which, in essence, merely recalls and comments on a number of paragraphs in the guidelines referred to in paragraph 213 of the present judgment, forms part of the preliminary considerations which led the General Court to state, in paragraph 131 of the judgment under appeal, that ‘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’. Since such preliminary considerations, by reason of their general nature, have no bearing on the operative part of that judgment, the complaint directed against paragraph 130 of that judgment is therefore ineffective. In addition, it follows from the considerations set out in paragraphs 142 to 147 of the present judgment, in response to the second part of the second ground of appeal, that paragraphs 179 to 208 of the judgment under appeal are vitiated by illegality. Accordingly, it is not necessary to respond to the complaints calling into question paragraphs 182 and 194 of the judgment under appeal.
216 Since the first to fourth parts are well founded, the third ground of appeal must be upheld.
6. The fourth ground of appeal
217 By its fourth ground of appeal, the Commission challenges the findings made by the General Court in relation to the intention of the parties to the Krka agreements. That ground of appeal has four parts.
(a) The first part
(1) Arguments of the parties
218 By the first part of its fourth ground of appeal, the Commission criticises the General Court for having held, in paragraph 251 of the judgment under appeal, that the decision at issue had failed to demonstrate that Servier or Krka had intended to conclude anticompetitive agreements. Such proof is not required, since the infringement attributed to those undertakings is a restriction of competition by object. Even if those undertakings did not intend to restrict competition, that circumstance has no bearing on the fact that the Krka agreements revealed, in Servier’s core markets, a sufficient degree of harm to competition to justify their characterisation as a restriction of competition by object.
219 Krka submits that, although proof of the anticompetitive intention of the parties is not required in order to establish that an agreement between undertakings restricts competition, nothing prevents the competition authorities or the courts from taking such an intention into account. The General Court held, correctly, that the Commission had not succeeded in establishing that the parties intended to share the national perindopril markets.
(2) Findings of the Court
220 After holding, in essence, in paragraph 221 of the judgment under appeal, that the Commission could not characterise the Krka settlement and licence agreements as a restriction of competition by object, the General Court held that that assessment could not be called into question by the other factors relied on in the decision at issue. Among those factors, paragraph 251 of that judgment states that ‘the Commission failed to demonstrate that Servier or Krka had intended to conclude a market-sharing or market exclusion agreement, that Servier had intended to induce Krka not to compete or that Krka had intended to agree, in exchange for an inducive benefit, not to exert competitive pressure on Servier’. For the reasons set out in paragraphs 252 to 260 of that judgment, the General Court then rejected certain evidence, relating to the intentions of the parties to the Krka agreements and referred to by the decision at issue, and found, in paragraph 261 of that judgment, that, in any event, the Commission had not been able to produce a body of relevant and consistent evidence capable of calling into question the conclusion which it had reached in paragraph 221 of the judgment under appeal.
221 In that regard, it should be recalled that, as noted in paragraphs 75 and 145 of the present judgment, the fact that undertakings whose conduct could be regarded as a restriction of competition by object acted without having an intention to prevent, restrict or distort competition and the fact that they pursued certain legitimate objectives are not decisive for the purposes of the application of Article 101(1) TFEU (see, to that effect, judgment of 21 December 2023, European Superleague Company, C‑333/21, EU:C:2023:1011, paragraph 167 and the case-law cited). Although evidence of the intentions of the parties to an agreement can, in certain cases, contribute to establishing the objective aims that that agreement is intended to achieve from a competition standpoint, it is clear from the case-law recalled in the present paragraph that, when it criticised the Commission for failing to demonstrate, in essence, that either Servier or Krka intended to restrict competition between them, whereas no such demonstration was required in order to establish the existence of a restriction of competition by object, the General Court erred in law and vitiated paragraph 251 of the judgment under appeal with illegality.
222 The first part of the fourth ground of appeal must, therefore, be upheld.
(b) The second part
(1) Arguments of the parties
223 By the second part of its fourth ground of appeal, the Commission submits that the General Court, in ruling in paragraphs 252 to 260 of the judgment under appeal on Servier’s and Krka’s intention to share the markets, erred in its interpretation of the principles governing the analysis of the evidence. It puts forward four complaints in that respect.
224 First, as regards the recognition by Servier and Krka of the validity of the 947 patent, the General Court confined itself, in paragraphs 253 to 260 of that judgment, to examining certain documents referred to in the decision at issue, whereas it was required to ascertain whether all the documentary evidence, analysed as a whole, made it possible to establish an infringement according to the standard of proof required. The General Court thus failed to take into consideration the documents referred to in recitals 873, 874 and 1759 of the decision at issue.
225 Second, as regards the importance attached, in paragraph 252 of that judgment, to the content of the Krka settlement and licence agreements, the General Court, in essence, followed an erroneous line of reasoning, of an ‘a contrario’ nature, and misinterpreted the case-law arising from the 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), concerning the inferences that may be drawn from indicia where the parties have not kept documentary evidence of the content of their agreement. The General Court inferred from this that the fact that the content of an agreement is available qualifies the relevance of the other documentary evidence. In the absence of that error of law, the General Court would have had to take into account an email from Krka of 29 September 2005 identifying the anticompetitive strategy pursued together with Lupin’s statement, which is referred to in recitals 1730 and 1748 of the decision at issue, corroborating the existence of that strategy.
226 Third, in paragraph 252 of the judgment under appeal, the General Court erred in law by holding, in a general and abstract manner, that documents contemporaneous with agreements ‘cannot easily call into question a finding based on the actual content of the agreements’. There is no such hierarchy in the production of evidence. The General Court failed to have regard to the essential function of evidence, which is to establish convincingly the merits of an argument, and erred in law by failing to verify the credibility of all the evidence referred to in recitals 1758 to 1760 of the decision at issue.
227 Fourth, the Commission submits that paragraph 255 of the judgment under appeal is insufficiently reasoned. In particular, that judgment fails to explain why the evidence referred to in recitals 1758 to 1760 of the decision at issue, read in conjunction with recitals 1687 to 1690 of that decision, was not sufficient to establish that Krka did not recognise the validity of the 947 patent.
228 According to Krka, the Commission’s line of argument aimed at calling into question both the General Court’s factual findings and its assessment of the evidence must be rejected as inadmissible.
229 Furthermore, that line of argument is unfounded.
230 First, the General Court did in fact examine whether the Commission’s findings were supported by all the evidence relied on in the decision at issue. That said, the General Court was not required to provide an account that followed all the arguments exhaustively, or to comment expressly on every item of evidence submitted by the Commission.
231 Second, the allegation that the Krka agreements had not been well publicised is contradicted by Lupin’s internal document referred to in recital 915 of the decision at issue. Krka notes that the Commission was able easily to obtain the full content of the Krka agreements.
232 Third, the argument that the General Court established a hierarchy of evidence is in its view unfounded. The General Court verified the reliability of all the factual material underpinning recitals 1758 to 1760 of the decision at issue.
233 Fourth, Krka submits that the Commission’s complaint directed against the probative value of the facts and the evidence on which the General Court relied in order to find that, at the time the Krka settlement and licence agreements were concluded, Krka believed the 947 patent to be valid is inadmissible.
(2) Findings of the Court
234 By the second part of its fourth ground of appeal, the Commission is not asking the Court of Justice to reassess facts or evidence, but is invoking the infringement of procedural rules relating to evidence. In contrast to Krka’s assertion, such a line of argument falls within the jurisdiction of the Court in appeal proceedings and is, therefore, admissible.
235 On the substance, since the Commission has put forward, in the context of its first complaint, arguments which overlap with those relied on in the fourth part of its fourth ground of appeal, it is appropriate to examine all of those arguments in the context of the assessment of that fourth part.
236 As regards the fourth complaint, alleging a failure to state reasons, it should be borne in mind that, according to the settled case-law of the Court of Justice, the statement of the reasons on which a judgment is based must clearly and unequivocally disclose the General Court’s thinking, so that the persons concerned can be apprised of the justification for the decision taken and the Court of Justice can exercise its power of review (judgment of 9 March 2023, Les Mousquetaires and ITM Entreprises v Commission, C‑682/20 P, EU:C:2023:170, paragraph 40 and the case-law cited).
237 In paragraph 255 of the judgment under appeal, the General Court rejected the evidence referred to in recitals 849 to 854 and 1758 to 1760 of the decision at issue, on the ground that it was too ‘fragmentary or ambiguous’ to cast doubt on the General Court’s finding that Krka had ultimately recognised the validity of the 947 patent. Although that reasoning is laconic, it is nevertheless sufficient for the purpose of understanding, in the light of paragraph 252 of that judgment, the reasons why the General Court thus disregarded that evidence. Since the fourth complaint is unfounded, it must be rejected.
238 As regards the second and third complaints, which it is appropriate to examine together, the Commission submits, in essence, that paragraph 252 of the judgment under appeal is vitiated by an error of law in that the General Court held that documents contemporaneous with agreements cannot easily call into question a finding based on the actual content of the agreements.
239 In paragraph 252 of the judgment under appeal, the General Court correctly recalled, referring to the judgment of 25 January 2007, Sumitomo Metal Industries and Nippon Steel v Commission (C‑403/04 P and C‑405/04 P, EU:C:2007:52, paragraph 51), that, even if the Commission discovers evidence explicitly showing unlawful contact between traders, it will normally be only fragmentary and sparse, so that it is often necessary to reconstitute certain details by deduction. However, the General Court considered, in paragraph 252, that the Krka settlement and licence agreements were ‘genuine contracts which, moreover, were well publicised (recital 915 of the [decision at issue])’, that, ‘since the Commission could easily obtain the full content of the agreements at issue, the applicability of the case-law which has just been cited is less evident’ and that, ‘thus, inferences drawn from partial extracts of emails or other documents purporting to establish the intentions of the parties cannot easily call into question a finding based on the actual content of the agreements, that is to say, on the legally binding relationship which the parties have decided to establish between themselves’.
240 In that regard, it must be borne in mind that, in EU law, the prevailing principle is that evidence may be freely adduced and that the only criterion for the purpose of assessing the evidence adduced is its credibility (judgments of 25 January 2007, Dalmine v Commission, C‑407/04 P, EU:C:2007:53, paragraphs 49 and 63, and of 27 April 2017, FSL and Others v Commission, C‑469/15 P, EU:C:2017:308, paragraph 38).
241 In order to satisfy the burden of proof incumbent on it, the Commission must gather sufficiently serious, precise and consistent evidence to support the firm conviction that the alleged infringement took place (see, to that effect, judgments of 28 March 1984, Compagnie royale asturienne des mines and Rheinzink v Commission, 29/83 and 30/83, EU:C:1984:130, paragraph 20, and of 25 January 2007, Sumitomo Metal Industries and Nippon Steel v Commission, C‑403/04 P and C‑405/04 P, EU:C:2007:52, paragraphs 42 and 45).
242 However, 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 body of evidence relied on by the institution, viewed as a whole, meets that requirement (see, to that effect, judgments 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 513 to 523, and of 14 May 2020, NKT Verwaltungs and NKT v Commission, C‑607/18 P, EU:C:2020:385, paragraph 180).
243 Those principles relating to the production of evidence apply not only where the Commission must infer the actual existence of a collusive practice from fragmentary and sparse evidence, but also where the content of agreements intended to implement that practice was available to the Commission. In such a situation, the actual content of those agreements does not necessarily make it possible to determine whether those agreements form part of an anticompetitive practice or, a fortiori, whether that practice reveals a sufficient degree of harm in order to be characterised as a restriction of competition by object (today’s judgment, Commission v Servier and Others, C‑176/19 P, paragraph 274).
244 As has already been stated, in paragraph 146 of the present judgment, in response to the second part of the second ground of appeal, the fact that the terms of agreements intended to implement a collusive practice do not reveal an anticompetitive object is not, in itself, decisive. That is why it is necessary to take into account not only the content of those agreements, but also their objectives and the economic and legal context of which they form part (see, to that effect, judgments of 26 November 2015, Maxima Latvija, C‑345/14, EU:C:2015:784, paragraph 20, and of 23 January 2018, F. Hoffmann-La Roche and Others, C‑179/16, EU:C:2018:25, paragraphs 78 and 79). In that regard, although the parties’ intention is not a necessary factor in determining whether an agreement between undertakings is restrictive, there is nothing prohibiting the competition authorities, the national courts or the Courts of the European Union from taking that factor into account (judgment of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraph 54 and the case-law cited), in particular in order to understand the true object of that agreement in the light of the context in which it was concluded, as held in paragraph 221 of the present judgment.
245 Therefore, first, the General Court infringed the principle that evidence may be freely adduced in EU law by holding, in paragraph 252 of the judgment under appeal, that there is a distinction in law, as regards the taking into account of fragmentary and sparse evidence in order to establish the existence of an infringement, between situations in which the content of anticompetitive agreements is available to the Commission and those in which that content is not available to it. Second, the General Court erred in law by observing, in paragraph 252, that ‘inferences drawn from partial extracts of emails or other documents purporting to establish the intentions of the parties cannot easily call into question a finding based on the actual content of the agreements, that is to say, on the legally binding relationship which the parties have decided to establish between themselves’. In so doing, the General Court vitiated its findings set out in paragraphs 252 to 261 of that judgment with illegality.
246 The second and third complaints of the second part of the fourth ground of appeal must therefore be upheld.
(c) The third part
(1) Arguments of the parties
247 By the third part of its fourth ground of appeal, the Commission submits that, for the reasons set out in the fifth part of its first ground of appeal, paragraphs 253 and 260 of the judgment under appeal are vitiated by an error of law.
248 According to Krka, the third part must be rejected for the same reasons as those which in its view justify rejecting the fifth part of the first ground of appeal.
(2) Findings of the Court
249 Since the fifth part of the first ground of appeal has been upheld in paragraph 127 of the present judgment, it is not necessary to rule separately on the third part of the fourth ground of appeal.
(d) The fourth part
(1) Arguments of the parties
250 By the fourth part of its fourth ground of appeal, the Commission criticises the General Court for having infringed, in paragraphs 235, 236, 246, 262 and 396 of the judgment under appeal, the principles requiring it to carry out an analysis of all the evidence. The General Court ‘preferred’ subjective evidence that postdates the conclusion of the Krka settlement and licence agreements to the contemporaneous evidence referred to in paragraphs 251 to 260 of that judgment, whereas the contemporaneous evidence would have enabled it to ascertain whether Krka actually recognised the validity of the 947 patent. Even though that undertaking claimed that the EPO decision of 27 July 2006 had led it to believe that the 947 patent was valid, such a claim could not stand up to an assessment of all the evidence. The General Court erred in law by failing to review all the evidence referred to in Section 5.5 of the decision at issue.
251 Krka asserts that that line of argument is unfounded. The General Court carried out a thorough and diligent evaluation of all relevant items of evidence, considered both individually and as a whole.
(2) Findings of the Court
252 By the first complaint of the second part of the fourth ground of appeal, and by the fourth part of that ground of appeal, the Commission submits, in essence, that the General Court erred in law in ruling on the existence of a restriction of competition by object on the basis of an incomplete and selective assessment of the evidence of Krka’s recognition of the validity of the 947 patent and of the intentions of the parties to the Krka agreements.
253 In that respect, it has been held in paragraphs 124 to 126 of the present judgment that, by failing to take into consideration the matters referred to in paragraphs 122 and 123 of the present judgment relating to Krka’s perception of the validity of the 947 patent, and by failing to explain the reasons for that omission, whereas the existence of an infringement of the competition rules can be assessed correctly only if the evidence relied on by the decision at issue is considered as a whole, the General Court distorted the decision at issue, resulting in the judgment under appeal being vitiated by a failure to state reasons. In those circumstances, the first complaint of the second part and the fourth part of the fourth ground of appeal must be upheld.
254 In the light of the foregoing considerations, the first part, the first to third complaints of the second part and the fourth part of the fourth ground of appeal must be upheld.
7. The fifth ground of appeal
255 By its fifth ground of appeal, the Commission disputes the General Court’s findings relating to the procompetitive effects of the Krka licence agreement.
(a) Arguments of the parties
256 By its fifth ground of appeal, the Commission criticises paragraphs 243 to 245 and 267 of the judgment under appeal, by which the General Court took into account the positive effects of the Krka licence agreement in Krka’s core markets. The General Court made three errors. First of all, since no infringement was found on those markets, the alleged positive effects do not justify the restriction of competition on the other markets. Next, the General Court misconstrued the judgment of 13 July 1966, Consten and Grundig v Commission (56/64 and 58/64, EU:C:1966:41), according to which, in essence, an exclusive distribution agreement which establishes absolute territorial protection constitutes a restriction of competition by object. Lastly, the General Court misconstrued the settled case-law according to which the weighing up of the positive and negative effects of an agreement on competition can be carried out only in the context of Article 101(3) TFEU.
257 Krka disputes that line of argument. First of all, it reiterates that it was not the Krka settlement and licence agreements but Servier’s patents – the validity of which the parties have recognised – that eliminated competition on Servier’s core markets. From that perspective, the Krka licence agreement is procompetitive.
258 Next, Krka submits that the Commission’s line of argument is based on a misinterpretation of the case-law arising from the judgment of 13 July 1966, Consten and Grundig v Commission (56/64 and 58/64, EU:C:1966:41), which concerned neither intellectual property rights nor the settlement of disputes relating to those rights, but an exclusive distribution agreement based on vertical cooperation. In the present case, according to Krka, the licence granted by Servier was not exclusive and the Krka settlement and licence agreements conferred no absolute territorial protection on the parties. Servier was able to remain in Krka’s core markets and Krka was able to market a non-infringing version of its perindopril on Servier’s core markets.
259 Lastly, Krka submits that the Commission’s line of argument is based on a misreading of paragraphs 239 to 250 of the judgment under appeal. The General Court did not weigh up the positive and negative effects of the Krka settlement and licence agreements, and sought, rather, to determine whether those agreements constituted a sharing of markets. That was the context in which the General Court found, inter alia, the existence of competition between Servier and Krka on Krka’s core markets. If the effects of those agreements on the markets in question were irrelevant, as the Commission was claiming, then there would have been no need to devote Section 5.5.3.3.3.2 of the decision at issue to that point.
(b) Findings of the Court
260 It should be borne in mind that, as the Court of Justice has held, in order to determine whether conduct reveals the degree of harm required in order to constitute a restriction of competition by object within the meaning of Article 101(1) TFEU, it is not necessary to examine nor, a fortiori, to prove, the effects of that conduct on competition, be they actual or potential, or negative or positive (judgment of 21 December 2023, European Superleague Company, C‑333/21, EU:C:2023:1011, paragraphs 159 and 166 and the case-law cited). It follows that any positive or procompetitive effects of conduct cannot be taken into account in order to determine whether it should be characterised as a restriction of competition by object under Article 101(1) TFEU, including in the context of any examination of whether the conduct at issue reveals the degree of harm required in order to be characterised as such.
261 In any event, as noted in paragraph 138 of the present judgment, the Krka licence agreement concerns markets which do not fall within the geographic scope of the infringement of Article 101 TFEU. In those circumstances, any procompetitive effects that that agreement might have on those markets, even if they exist, would be irrelevant, from a logical standpoint, for the purpose of determining the existence of the infringement found in the present case on Servier’s core markets.
262 Therefore, by relying, in paragraph 267 of the judgment under appeal and in paragraph 268 thereof which draws the appropriate conclusions, on the procompetitive effects that it had found to exist on Krka’s core markets, in paragraphs 243 to 245 of that judgment, the General Court erred in its interpretation and application of Article 101(1) TFEU and vitiated all those paragraphs with illegality.
263 The fifth ground of appeal must, therefore, be upheld.
8. Interim conclusion on the first to fifth grounds of appeal
264 By the judgment under appeal, the General Court held, in essence, that, in order to characterise the Krka settlement and licence agreements as a restriction of competition by object, it was for the Commission to establish, first, that there was a sufficiently direct link between those two agreements for their association to be justified and, second, that, in the absence of such a link, it was for the Commission to prove that the Krka licence agreement had not been concluded at arm’s length, but masked a reverse payment from Servier to Krka intended to delay Krka’s entry into Servier’s core markets.
265 As is apparent from paragraphs 95 to 97 and 142 to 147 of the present judgment, the General Court disregarded the very nature of the infringement of Article 101 TFEU attributed to Servier and Krka, an infringement which was not limited to a patent dispute settlement agreement in return for reverse payment but pursued the broader objective of sharing markets between those undertakings. It also disregarded the geographic scope of that infringement which did not extend to Krka’s core markets.
266 That error of law led the General Court, as is apparent from paragraphs 141 to 147 of the present judgment, to verify whether the unlawful practice attributed to Servier and Krka should be characterised as a restriction of competition by object by analysing the form and legal characteristics of the agreements intended to implement that practice, rather than by having regard to the economic impacts of that practice. It is in the light of those incorrect criteria that the General Court attached decisive importance to Krka’s recognition of the validity of the 947 patent and to the question whether the royalty rate of the Krka licence agreement was in line with normal market conditions, whereas, as is apparent from paragraphs 158 to 162 and 186 to 189 of the present judgment, those factors were not, in themselves, decisive.
267 Furthermore, when, on the basis of those errors of law, the General Court examined whether the conclusion of the Krka settlement and licence agreements was justified by the fact that Krka, having suffered two legal setbacks, was no longer convinced that the 947 patent was invalid, the General Court, as is apparent from paragraphs 109 to 126 of the present judgment, distorted the clear and precise sense of one of those judicial decisions and, as regards the other, distorted the decision at issue and infringed its obligation to state reasons.
268 In addition, in order to support the conclusion – vitiated by the errors of law just summarised – that the Commission could not characterise the Krka settlement and licence agreements as a restriction of competition by object, the General Court disputed seven factors which, according to the decision at issue, demonstrated that the Krka licence agreement was the quid pro quo for that undertaking’s commitment not to compete with Servier on its core markets.
269 First, the General Court disputed, in paragraphs 223 to 227 of the judgment under appeal, the prospect of a de facto duopoly between Servier and Krka being established on Krka’s core markets, on the ground that that duopoly was the result not of the Krka licence agreement, but of subsequent choices made by the parties to that agreement. However, that finding is based solely on an examination of the content of the clauses of that agreement, without regard to its economic context, and on a distortion of the wording of one of those clauses, as is apparent from paragraphs 141 to 147 and 193 to 195 of the present judgment.
270 Second, the General Court rejected, in paragraphs 228 to 235 of the judgment under appeal, the possibility that the Krka licence agreement could have constituted the quid pro quo for the Krka settlement agreement, on the ground that it was Krka’s recognition of the validity of the 947 patent that was the decisive factor in its decision to settle. However, that assessment is based (i) on the error of law found in paragraphs 186 to 189 of the present judgment as regards the decisive nature of that recognition and (ii) on the distortions and failure to state reasons found in paragraphs 109 to 126 and in paragraphs 252 to 254 of the present judgment.
271 Third, the General Court stated, in paragraphs 236 to 238 of the judgment under appeal, that Krka’s assessment of the opportunity cost of the Krka settlement agreement did not establish that the Krka licence agreement was the quid pro quo for the Krka settlement agreement, but rather confirms that Krka recognised the validity of the 947 patent. However, that circumstance is not, in itself, decisive, as is apparent from paragraphs 186 to 189 of the present judgment.
272 Fourth, the General Court found, in paragraphs 238 to 250 of the judgment under appeal, first of all, that, in the absence of markets reserved for Krka, the Commission had not proved the existence of a ‘hermetic’ division of the markets, next, that the licence had had a procompetitive effect on Krka’s core markets, and, lastly, that no part of the market had been unlawfully reserved for Servier. However, it is apparent from paragraphs 178 to 181, 188 and 189 of the present judgment that those findings are based on (i) a formalistic analysis of the Krka settlement and licence agreements rather than on the specific analysis of their harmfulness to competition and (ii) an error of interpretation of Article 101(1) TFEU, since the prohibition of agreements aimed at partitioning markets is not applicable only to agreements that effect a ‘hermetic’ division between those markets.
273 Fifth, the General Court held, in paragraphs 251 to 261 of the judgment under appeal, that the Commission had failed to demonstrate that Servier and Krka intended to conclude a market-sharing agreement. However, besides the fact that, as held in paragraph 221 of the present judgment, the Commission was not required to prove that Servier or Krka intended to restrict competition between them, it is apparent from paragraphs 109 to 126 and 238 to 245 of the present judgment that that finding is based on a distortion of the decision at issue and of the decision of the High Court of 3 October 2006, on an infringement of the obligation to state reasons for judgments and on an incorrect application of the principles relating to the production of evidence.
274 Sixth, the General Court found, in paragraphs 262 to 264 of the judgment under appeal, that the fact that Krka continued to challenge Servier’s patents after the EPO decision of 27 July 2006 did not mean that that decision did not have a decisive impact on Krka’s perception of the validity of the 947 patent and that Krka continued to exert competitive pressure on Servier. According to the General Court, that continuation of litigation could be explained by Krka’s desire to strengthen its position in the negotiations with Servier and by its belief that it would run only a limited risk of being the subject of actions for infringement. However, it is apparent from paragraphs 92 to 99 and 109 to 126 of the present judgment that that finding of the General Court is based on the incorrect premiss that Krka’s recognition of the validity of the 947 patent was decisive, a premiss which is itself based on the distortion not only of an item of evidence but also of the decision at issue as such and on a failure to state reasons in the judgment under appeal.
275 Seventh, the General Court reiterated, in paragraphs 265 to 267 of the judgment under appeal, its position that (i) the Krka licence agreement was based on that undertaking’s recognition of the validity of the 947 patent and (ii) the Commission had not established that that agreement had not been concluded at arm’s length. However, it is apparent from paragraphs 57 to 71, 93 to 96 and 158 to 162 of the present judgment that those findings are based on the application of criteria which are wrong in law.
276 In the light of all the foregoing and having regard to the breadth, nature and scope of the errors of law made by the General Court identified in the analysis of the first to fifth grounds of appeal, it must be held that those errors affect the entirety of the reasoning – set out in paragraphs 179 to 268 of the judgment under appeal – relating to the characterisation of the Krka settlement and licence agreements as a restriction of competition by object.
9. The sixth ground of appeal
277 By its sixth ground of appeal, the Commission disputes the refusal by the General Court to characterise the Krka assignment and licence agreement as a restriction of competition by object within the meaning of Article 101(1) TFEU.
(a) Arguments of the parties
278 The Commission submits that the General Court erred in law by refusing, in paragraphs 279 to 298 of the judgment under appeal, to recognise that the Krka assignment and licence agreement constituted a restriction of competition by object. The General Court held that that characterisation was based on the incorrect finding that there was market sharing between Krka and Servier. Since, according to the Commission, that finding is based on an incorrect premiss, it cannot be allowed to stand. That institution submits moreover that the General Court did not provide an adequate statement of reasons for that finding.
279 Krka submits that the reasoning in the judgment under appeal is sufficient. It also asserts that the General Court, after refuting, in paragraphs 239 and 250 of that judgment, the existence of a market-sharing agreement, and finding, in paragraphs 291 to 293 and 298 of that judgment, that the Commission had failed to establish that the Krka licence agreement had induced Krka to conclude the Krka settlement agreement, was entitled to find that the Krka assignment and licence agreement did not constitute a restriction of competition by object.
(b) Findings of the Court
280 In paragraphs 291, 292 and 297 of the judgment under appeal, the General Court noted that, in the decision at issue, the Commission had characterised the Krka assignment and licence agreement as a restriction of competition by object by relying on the finding of the existence of a market-sharing agreement as a result of the Krka settlement and licence agreements. That finding having been invalidated by the General Court, the latter considered that it was also necessary, for that reason alone, to reject the characterisation of the Krka assignment and licence agreement as a restriction of competition by object.
281 However, it follows from the examination of the first to fifth grounds of appeal that the General Court’s reasoning – set out in paragraphs 179 to 268 of the judgment under appeal – relating to the characterisation of the Krka settlement and licence agreements is vitiated by illegality in its entirety. Since the premiss of the reasoning by which the General Court rejected the characterisation of the Krka assignment and licence agreement as a restriction of competition by object is thus vitiated, the sixth ground of appeal must be upheld.
B. The seventh ground of appeal, relating to the existence of a restriction of competition by effect within the meaning of Article 101(1) TFEU
282 The seventh ground of appeal criticises the General Court’s finding that the Krka agreements cannot be characterised as a restriction of competition by effect.
1. The relevant sections of the decision at issue and the relevant paragraphs of the judgment under appeal
(a) The decision at issue
283 In recitals 1214 to 1218 of the decision at issue, the Commission stated that, in order to assess the anticompetitive effects of an agreement, account should be taken of the actual circumstances in which those effects are produced, in the light not only of current competition, but also of potential competition. In recitals 1219 and 1220 of that decision, the Commission stated that that assessment should be carried out on the basis of the facts at the time that agreement was concluded, while taking into account how it was actually implemented.
284 In recitals 1221 to 1227 of the decision at issue, the Commission stated that the effects of an agreement must be compared with what would have happened in the absence of that agreement, in particular as regards potential competition. According to recitals 1228 to 1243 of that decision, the main competitive constraint exercised on the perindopril market resulted from the entry into that market of generic versions of that medicinal product, without which Servier could maintain its prices at a level above the competitive price. The settlement agreements concluded by that undertaking with manufacturers of generic medicines therefore directly produced anticompetitive effects. In recitals 1244 to 1269 of that decision, the Commission stated that, after the conclusion of settlement agreements with Niche, Matrix, Teva, Krka and Lupin, only two manufacturers of generic medicines – Apotex and Sandoz – constituted a significant threat of entry to Servier’s core markets, which shows that, faced with a small number of potential competitors, the elimination of a single one is sufficient to significantly reduce the likelihood of such entry.
285 As regards, more specifically, the characterisation of the Krka agreements as a restriction of competition by effect on the markets in France, the Netherlands and the United Kingdom, which were the only ones relied on for the purposes of establishing that infringement, it is apparent from recitals 1813 to 1850 of the decision at issue that Krka was a potential competitor of Servier on those markets and had real and concrete possibilities of entering those markets within a short period. Krka had initiated litigation in the United Kingdom and was preparing to enter those markets. By inducing that undertaking to abandon that plan, the Krka agreements had the effect of eliminating a source of potential competition.
286 In addition, those agreements significantly reduced the risk of entry of other manufacturers of generic medicines to which Krka could have supplied perindopril products. On the basis of those factors, the Commission found that those agreements had the effect of appreciably restricting potential competition, noting in that regard, in recital 1850 of that decision, that those agreements ‘appreciably increased the likelihood that Servier’s market exclusivity would remain uncontested for a longer period of time and that consumers would forego a significant reduction of prices that would ensue from timely and effective generic entry’.
(b) The judgment under appeal
287 For the reasons set out in paragraphs 315 to 472 of the judgment under appeal, the General Court upheld the fifth plea at first instance, by which Krka disputed the characterisation of the Krka agreements as a restriction of competition by effect on the three geographic markets concerned.
288 In the first place, after recalling, in paragraphs 317 to 342 of that judgment, the grounds which led the Commission to adopt that classification, the General Court held, in paragraphs 345 to 377 of that judgment, that the case-law relating to the taking into account of the potential effects of an agreement, in particular that resulting from the judgments of 21 January 1999, Bagnasco and Others (C‑215/96 and C‑216/96, EU:C:1999:12, paragraph 34), of 23 November 2006, Asnef-Equifax and Administración del Estado (C‑238/05, EU:C:2006:734, paragraph 50), of 28 February 2013, Ordem dos Técnicos Oficiais de Contas (C‑1/12, EU:C:2013:127, paragraph 71), and of 26 November 2015, Maxima Latvija (C‑345/14, EU:C:2015:784, paragraph 30), is inapplicable where that agreement has already been implemented. According to the General Court, the Commission cannot find a restriction of competition by effect solely on the basis of a limitation, or even the elimination, of a source of potential competition. Proof of such effects requires account to be taken, in the interests of being realistic, of all the relevant factual developments, including those subsequent to the conclusion of the agreement concerned.
289 In the second place, the General Court found, in paragraphs 378 to 455 of the judgment under appeal, that the Commission, by relying solely on an impediment to potential competition and on hypothetical considerations, erred in characterising the Krka settlement agreement and the Krka assignment and licence agreement as restrictive of competition by effect.
290 First of all, for the reasons set out in paragraphs 380 to 425 of that judgment, the General Court held that the Commission had not demonstrated that, in the absence of the non-marketing clause provided for in the Krka settlement agreement, Krka would probably have entered the markets in France, the Netherlands and the United Kingdom. According to that judgment, the Commission failed to take into account the fact that Krka recognised the validity of the 947 patent and failed to demonstrate that, in the absence of that agreement, competition would probably have been more open, since it had not specified the probable effects of such a situation on prices, production or innovation.
291 Next, the General Court held, in paragraphs 426 to 451 of that judgment, that the Commission had not established that, in the absence of the non-challenge clause provided for in the Krka settlement agreement, it was probable, or even plausible, that the continuation of the litigation relating to the 947 patent would have allowed a faster or more complete invalidation of the patent. According to the General Court, the Commission therefore failed to demonstrate that that clause had the effect of restricting competition.
292 Lastly, the General Court noted, in paragraphs 452 and 453 of that judgment, that the Commission had not demonstrated that the Krka assignment and licence agreement had the effect of restricting competition, since that agreement did not provide for any exclusionary measure similar to a non-marketing clause.
293 In the third place, after upholding, in paragraphs 454 and 455 of the judgment under appeal, the plea alleging the absence of anticompetitive effects of the Krka agreements, the General Court examined ‘whether the Commission ‘[had] in addition, … vitiated [the decision at issue] by an error of law’. In that regard, it found, in paragraphs 457 to 470 of that judgment, that, by failing to take into account the course of events observable at the date of the decision at issue and by analysing competition in the absence of the Krka agreements on the basis of hypothetical considerations, the Commission had unjustifiably limited its examination of the effects on competition of those agreements, both in the light of the case-law relating to the taking into account of potential effects on competition and of the case-law relating to the elimination of potential competition. In the General Court’s view, such an incomplete examination is contrary to the distinction established in Article 101(1) TFEU between restrictions of competition by object and restrictions of competition by effect.
2. Arguments of the parties
294 The seventh ground of appeal consists of seven parts.
295 By the first part, the Commission complains that the General Court held, in paragraphs 366, 416, 417 and 465 to 470 of the judgment under appeal, that the effect of restricting potential competition, although an actual effect, was not sufficient for a finding of a restriction of competition by effect.
296 By the second part, the Commission submits that the General Court erred in its interpretation and application of Article 101(1) TFEU, in paragraphs 360 to 362, 365, 366 and 463 of the judgment under appeal, in finding that taking potential effects into account was not sufficient to establish the effects of an agreement which had already been implemented.
297 By the third part, the Commission criticises paragraphs 398, 399, 403, 406, 407, 411, 412, 416, 441, 446 and 449 of the judgment under appeal. It complains that the General Court held that it was required to demonstrate that Krka would probably have entered the perindopril market in France, the Netherlands and the United Kingdom in the absence of the Krka agreements, in particular by engaging in speculation on the outcome of the disputes relating to the 947 patent.
298 By the fourth part, the Commission criticises paragraphs 368 to 371, 389, 408, 419, 436, 438, 448 and 458 of the judgment under appeal. In particular, the General Court required, in paragraph 368 of that judgment, that the Commission take into account factual developments subsequent to the conclusion of the agreements. However, an agreement must be analysed at the date on which it was concluded, on the basis of the likely developments that would have occurred on the market in the absence of that agreement.
299 By the fifth part, the Commission submits that, in paragraphs 386 to 389 and 392 of the judgment under appeal, the General Court distorted the decision at issue in stating that that decision had not taken into account the effects of the 947 patent and Krka’s recognition of the validity of that patent.
300 By the sixth part, the Commission complains that the General Court substituted its own assessment of the facts for the findings in the decision at issue, thereby exceeding the limits of the review of lawfulness. The General Court thus held, in paragraphs 400 to 408 of the judgment under appeal (i) that Krka’s decision to continue to challenge the 947 patent, after the EPO decision of 27 July 2006, was a mere ploy intended to strengthen its position in its negotiations with Servier, whereas that assessment is not based on any contemporaneous evidence and (ii) that Krka would probably not have entered Servier’s core markets.
301 By the seventh part, the Commission takes issue with paragraphs 435 to 447 of the judgment under appeal. The General Court wrongly placed on the Commission the burden of demonstrating that Krka’s continuance of the legal proceedings relating to the patents would have made it possible to invalidate the 947 patent more quickly or more fully.
302 In respect of the first part, Krka recalls that, in paragraph 315 of the judgment under appeal, the General Court explained that demonstrating an effect restrictive of competition consists in ‘show[ing] – by a comparison between the competition that existed when the agreement was in force and the competition that would have occurred if that agreement had not been concluded – that the competitive situation was worse when that agreement was in force’. In the present case, the General Court correctly found that the Commission had failed to establish that the competitive situation would have been better in the absence of the Krka agreements. Analysis of competition on the market at the time those agreements were concluded should take into account the fact that the validity of the 947 patent had been confirmed by the EPO decision of 27 July 2006 and was recognised by Krka. Under those circumstances, even if Krka was a potential competitor of Servier, its exclusion from the market could not, of itself, affect competition, unless it is demonstrated that, in the absence of those agreements, Krka would probably have entered Servier’s core markets. Such a burden of proof is reasonable and accords with the spirit of the distinction between restrictions of competition by object and restrictions of competition by effect. The Commission therefore erred, according to Krka, by stating that the elimination of an important source of potential competition can, in itself, give rise to a reasonable degree of probability that competition will be restricted.
303 In respect of the second part, Krka submits that the General Court correctly applied the case-law that requires evidence establishing that competition was actually prevented, restricted or distorted. The General Court added, correctly, in paragraphs 367 to 369 of the judgment under appeal, that the demonstration in question must be realistic and must take into account all the relevant factual developments, including those subsequent to the conclusion of the agreement concerned but occurring before a decision is adopted by the Commission.
304 According to Krka, agreements that have been implemented but have no actual effects cannot harm competition. Furthermore, although Article 101(1) TFEU permits both the actual and potential effects of an agreement on competition to be taken into account, that latter category of effects can only be taken into consideration so long as the agreement in question has not been implemented. It is not permissible under the case-law to find that an implemented agreement can be characterised as a restriction of competition by effect solely by reason of its potential effects. Krka submits in that respect that the examination of the relevant case-law undertaken by the General Court in paragraphs 345 to 365 of the judgment under appeal is not vitiated by any error of law. Krka states that, in line with the judgment of 28 February 2013, Ordem dos Técnicos Oficiais de Contas (C‑1/12, EU:C:2013:127, paragraph 72), potential effects are not possible effects that in reality did not happen, but effects that, although future, are likely to happen.
305 In respect of the third part, Krka notes that, in recitals 1715, 1718 and 1720 of the decision at issue, the Commission had found that one of the effects of the non-marketing clause provided for in the Krka settlement agreement had been to prevent an ‘at risk’ entry by Krka into Servier’s core markets. The General Court held that finding not to be justified. The Commission could not assert that the Krka agreements had the effect of preventing Krka from entering Servier’s core markets. In fact, as a result of the EPO decision of 27 July 2006, such an entry was unlikely since it would have exposed Krka to the risk of being the subject of infringement actions. The Commission accordingly appears to have relied on a counterfactual scenario that ignores the fact that, as a result of that EPO decision, Krka had recognised the validity of the 947 patent and decided to develop a generic version of perindopril that does not infringe the 947 patent.
306 According to Krka, the case-law requires the counterfactual scenario to be realistic and, where appropriate, to take account of the likely developments that would occur on the market in the absence of the agreements in question. According to the judgment of 11 September 2014, MasterCard and Others v Commission (C‑382/12 P, EU:C:2014:2201, paragraph 173), such a scenario should be not only economically viable but also plausible, or indeed likely.
307 In Krka’s view, the counterfactual scenario used by the Commission clearly did not satisfy those criteria. First, although Krka’s perindopril obtained marketing authorisation in May 2006, it was not immediately placed on the market in France, the Netherlands and the United Kingdom. Krka states that it wanted to await the outcome of the opposition proceedings before the EPO. Consequently, after the EPO decision of 27 July 2006, it would not enter those markets because its strategy of seeking to obtain revocation of the 947 patent had failed. Second, in the United Kingdom, Krka was subject to an interim injunction that deprived it of any real and concrete possibility of entering the market of that then Member State.
308 Krka states that, in practice, it is common to expect that the national courts will grant interim measures as soon the EPO confirms the validity of a patent. Even if Krka had entered the markets in France, the Netherlands and the United Kingdom, it would then undoubtedly have been the subject of interim injunctions.
309 In respect of the fourth part, Krka recalls that the counterfactual scenario must be realistic and must take into account all the relevant factual developments.
310 In respect of the fifth part, Krka submits that the complaint relating to distortion is inadmissible, since the Commission is in reality seeking a reassessment of the evidence by the Court of Justice. That complaint is in any event, unfounded. In Krka’s view, the Commission has not in any way established the existence of the alleged distortions. The General Court, in paragraphs 337, 338 and 388 of the judgment under appeal, analysed the recitals of the decision at issue to which the Commission refers.
311 In respect of the sixth part, Krka submits that the Commission is asking the Court of Justice to re-examine the facts. On the substance, Krka refers to its observations in response to, first, the fourth part of the first ground of appeal and, second, the third part of the present ground of appeal, by which it set out why, in the absence of the Krka settlement and licence agreements, its entry into the markets in France, the Netherlands and the United Kingdom would have been unlikely.
312 Krka disputes the admissibility of the seventh part, since the distortion alleged by the Commission does not satisfy the necessary conditions. On the substance, the Commission’s statement that there were other possible counterfactual hypotheses is, according to Krka, wrong and unsupported by any evidence in the file.
3. Findings of the Court
313 In respect of the admissibility of the fifth to seventh parts of the seventh ground of appeal, it should be noted that by those parts the Commission alleges, in turn, a distortion of the decision at issue, failure to observe the limits of judicial review and misconstruction of the burden of proof to be met by that institution in order to establish a restriction of competition by effect. In contrast to Krka’s claim, the errors of law thereby alleged by the Commission are all matters within the jurisdiction of the Court of Justice in appeal proceedings. It follows that the fifth to seventh parts of the seventh ground of appeal are admissible.
314 On the substance, by its seventh ground of appeal, the Commission essentially criticises the General Court for having considered that the decision at issue had not established that the Krka agreements had had the effect of restricting potential competition, since that institution had failed to prove that, in the absence of those agreements, Krka would probably have entered Servier’s core markets.
315 In that respect, it should be noted that an agreement between undertakings may fall within the scope of Article 101(1) TFEU, not only on account of its object, but also because of its effects on competition, including where those effects affect potential competition exerted by one or more undertakings which, although absent from the relevant market, have the ability to enter it, and thereby affect the conduct of undertakings already present on that market. The burden of proving such effects on potential competition is borne by the Commission (today’s judgment, Commission v Servier and Others, C‑176/19 P, paragraph 338).
316 According to the settled case-law of the Court of Justice, recalled by the General Court in paragraph 315 of the judgment under appeal, in order to assess the existence of anticompetitive effects caused by an agreement between undertakings, it is necessary to compare the competitive situation resulting from that agreement and the situation that would exist in its absence (see, to that effect, judgments of 30 June 1966, LTM, 56/65, EU:C:1966:38, p. 250; of 11 September 2014, MasterCard and Others v Commission, C‑382/12 P, EU:C:2014:2201, paragraph 161; and 18 November 2021, Visma Enterprise, C‑306/20, EU:C:2021:935, paragraph 74).
317 The purpose of that ‘counterfactual’ method is to identify, in the context of the application of Article 101(1) TFEU, the existence of a causal link between, on the one hand, an agreement between undertakings and, on the other, the structure or functioning of competition on the market within which that agreement produces its effects. That method thus makes it possible to ensure that characterisation as a restriction of competition by effect is reserved for agreements displaying not a mere correlation to a deterioration in the competitive situation of that market, but for those agreements that are the cause of that deterioration.
318 The raison d’être of the counterfactual method is that any attempt to identify such a relationship of cause and effect runs up against the fact that it is impossible, in practice, to observe the state of the market at the same time with and without the agreement concerned, as those two states are, by definition, mutually exclusive. It is therefore necessary to compare the observable situation, namely that resulting from that agreement, with the situation which would have arisen had that agreement not been adopted. That method therefore requires an observable situation to be compared with a scenario which, by definition, is hypothetical, in the sense that it has not materialised. When appraising the effects of an agreement between undertakings in the light of Article 101 TFEU, it is necessary to take into consideration the actual context in which that agreement is situated, in particular the economic and legal context in which the undertakings concerned operate, the nature of the goods or services affected, as well as the real conditions of the functioning and the structure of the market or markets in question. It follows that the counterfactual scenario, envisaged on the basis of the absence of that agreement, must be realistic and credible (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraphs 115 to 120).
319 It is therefore essential, for the correct application of the counterfactual method, to ensure that the comparison made is based on sound and verifiable grounds, as regards both the observed situation – that resulting from the agreement between undertakings – and the counterfactual scenario. In order to do so, the time reference point for making such a comparison must be the same for the situation observed and for the counterfactual scenario, since the anticompetitive nature of an act must be evaluated at the time when it was committed (see, to that effect, judgment of 6 December 2012, AstraZeneca v Commission, C‑457/10 P, EU:C:2012:770, paragraph 110).
320 It follows that, in so far as the counterfactual scenario is intended to give a realistic picture of the market situation as it would have occurred in the absence of the agreement that was concluded, that scenario cannot be based on events subsequent to the date of conclusion of that agreement precisely because, on that date, those events had not occurred and, in the circumstances of the present case, could not occur in the future due to the existence of the Krka agreements (today’s judgment, Commission v Servier and Others, C‑176/19 P, paragraph 343).
321 Unlike the counterfactual scenario, the situation observed is that corresponding to the competitive conditions which exist at the time of conclusion of the agreement and which result from it. That situation is what actually occurred and it is therefore not necessary to rely on realistic assumptions in order to assess it. Accordingly, for the purposes of establishing an infringement of Article 101 TFEU, events subsequent to the conclusion of that agreement may be taken into account in order to assess that situation. However, in accordance with the case-law referred to in paragraph 319 of the present judgment, such events are relevant only in so far as they help to determine the competitive conditions obtaining at the time when that infringement was committed, as they result directly from the existence of that agreement.
322 In the present case, in paragraphs 317 to 341 of the judgment under appeal, the General Court analysed the approach taken by the Commission in the decision at issue in order to characterise the patent dispute settlement agreements between Servier and the manufacturers of generic medicines referred to in that decision, and emphasised the hypothetical nature of that approach. It moreover held, in paragraphs 345 to 377 of that judgment, that the case-law according to which an agreement between undertakings may be classified as a restriction of competition by effect by reason of its potential effects ceases to be applicable once the agreement has been implemented.
323 As the actual effects of such an agreement on competition can be observed in the light of events subsequent to its conclusion, the General Court held, in paragraphs 360 and 361 of that judgment, that it would be paradoxical to allow the Commission to prove the existence of anticompetitive effects by merely carrying out a counterfactual analysis on the basis solely of the potential effects of an agreement, when (i) the Commission has observable evidence as to the actual effects of that agreement and (ii) it is only where there is a restriction of competition by object that the burden, which falls on the Commission, to prove the anticompetitive effects may be lightened.
324 In so doing, the General Court misconstrued, in three main respects, the characteristics of the counterfactual method inherent in the assessment of a restriction of competition by effect, for the purposes of applying Article 101 TFEU.
325 In the first place, the General Court held that the assessment of the anticompetitive effects of the Krka settlement agreement was based on a hypothetical approach and an incomplete examination of those effects, since the Commission had not included in the counterfactual scenario the actual course of events subsequent to that agreement. However, that reasoning of the General Court disregards the fact that, as recalled in paragraphs 318 to 320 of the present judgment, identifying the anticompetitive effects of an agreement requires recourse to a counterfactual scenario which, by definition, is hypothetical, in the sense that it has not materialised, and which cannot therefore be based on matters subsequent to the conclusion of that agreement. It follows that the General Court erred in law in the interpretation and application of Article 101(1) TFEU and vitiated with illegality the grounds set out in paragraphs 317 to 341, 389, 408, 419, 441, 448, 457 to 461 and 465 of the judgment under appeal.
326 In the second place, by holding, in paragraphs 345 to 377 of the judgment under appeal, that the case-law according to which an agreement between undertakings may be classified as a restriction of competition by effect by reason of its potential effects ceases to be applicable once that agreement has been implemented, on the ground that the actual effects of that agreement on competition can be observed, the General Court based its reasoning on an imperfect understanding of the raison d’être, object and functioning of the counterfactual method, which are recalled in paragraphs 317 to 321 of the present judgment.
327 It is true that, in the case of an agreement the implementation of which has changed the number or conduct of undertakings already present within the same market, the application of the counterfactual method may, from a practical point of view and depending on the factual circumstances, amount to a comparison between, on the one hand, the state of competition between those undertakings before the conclusion of that agreement and, on the other, the coordination between those undertakings brought about by the implementation of that agreement, which may be evidenced, where applicable, by events subsequent to its conclusion.
328 However, where an agreement leads not to a change but, on the contrary, to keeping unchanged the number or the conduct of competing undertakings already present within that market by postponing or delaying the entry of a new competitor to that market, a mere comparison between the situations found to exist on that market before and after the implementation of that agreement would be insufficient to support the conclusion that there has been no anticompetitive effect. In such a situation, the anticompetitive effect arises from the certain disappearance, as a result of that agreement, of a source of competition which, at the time that agreement was concluded, remains potential, in so far as it is exerted by an undertaking which, although not yet present on the market concerned, is nevertheless capable of affecting the conduct of the undertakings already present on that market because of the credible threat of its entering that market.
329 Moreover, the distinction drawn by the General Court in paragraphs 345 to 377 of the judgment under appeal, for the purposes of classifying agreements concluded by undertakings as a restriction of competition by effect, depending on whether or not the agreement has been implemented, disregards the settled case-law of the Court of Justice, according to which restrictive effects on competition may be both actual and potential, but must be sufficiently appreciable (see, to that effect, judgments of 9 July 1969, Völk, 5/69, EU:C:1969:35, paragraph 5/7, and of 23 November 2006, Asnef-Equifax and Administración del Estado, C‑238/05, EU:C:2006:734, paragraph 50), and would be tantamount to reducing the full effectiveness of the prohibition laid down in Article 101(1) TFEU.
330 In the third place, as noted in paragraph 317 of the present judgment, the counterfactual method is not intended to foresee what a party’s conduct would have been if it had not concluded an agreement with its competitor or competitors, but to identify a causal relationship between that agreement and a deterioration in the competitive situation on the market, on the basis of a counterfactual scenario which, although hypothetical, must nevertheless be realistic and credible. In that regard, the Court has already had occasion to state, in the context of a patent dispute settlement agreement in return for reverse payment, that the sole purpose of the counterfactual scenario is to establish the realistic possibilities with respect to the conduct of the manufacturer of generic medicines in the absence of that agreement. While that counterfactual scenario cannot be unaffected by the chances of success of that manufacturer in the patent proceedings or again in relation to the probability of the conclusion of a less restrictive agreement, those factors constitute, however, only some factors among many to be taken into consideration. Consequently, it is not for the entity bearing the burden of proving the existence of appreciable potential or real effects on competition, when it establishes the counterfactual scenario, to make a definitive finding in relation to the chances of success of the manufacturer of generic medicines in the patent dispute or to the probability of the conclusion of a less restrictive agreement (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraphs 119 to 121).
331 It follows from those factors that the Commission is required to prove that the counterfactual scenario used in a decision finding the existence of a restriction of competition by effect is realistic and credible.
332 In the present case, the General Court was required to ascertain whether the counterfactual scenario used by the Commission met those criteria. Since the restriction of competition found in the decision at issue consisted of the certain and deliberate elimination of the source of potential competition exerted by Krka on Servier by means of its perindopril composed of the alpha crystalline form of erbumine protected by the 947 patent, analysis of the counterfactual scenario amounted, in essence, to analysing whether that potential competition existed, since the elimination of such competition, if established, is by definition a sufficiently appreciable effect on competition for the purpose of the case-law recalled in paragraph 329 of the present judgment. Thus, in order to determine whether, by prohibiting Krka from entering the markets in France, the Netherlands and the United Kingdom, the Krka agreements had a proven effect on potential competition, it was necessary to ascertain, in accordance with the case-law referred to in paragraph 68 and what has been held in paragraph 328 of the present judgment, whether Krka had a real and concrete possibility of entering those markets within a period of time capable of putting competitive pressure on Servier, with the result that the threat of such an entry could be regarded as realistic and credible.
333 By holding, in paragraphs 380 to 406 of the judgment under appeal, that the Commission had not proved that, in the absence of the non-marketing clause provided for in the Krka settlement agreement, Krka would probably have entered the markets in France, the Netherlands and the United Kingdom and, in paragraphs 426 to 451 of that judgment, that the Commission had not proved that, in the absence of the non-challenge clause provided for in that agreement, the continuation of the litigation challenging the validity of the 947 patent would, to use the words of paragraph 440 of that judgment, ‘probably, or even plausibly, have allowed a faster or more complete invalidation of the patent’, the General Court erred in its interpretation and application of Article 101(1) TFEU and paragraphs 385 to 406 and 426 to 451 of the judgment under appeal were as a result vitiated with illegality.
334 The errors of law thus identified vitiate with illegality the entirety of the General Court’s reasoning relating to the characterisation of the Krka agreements as a restriction of competition by effect set out in paragraphs 315 to 472 of the judgment under appeal.
335 In the light of the foregoing, the seventh ground of appeal must be upheld, without its being necessary to rule separately on each of the parts of that ground of appeal, and in particular on the fifth part, alleging distortion of the decision at issue, and on the sixth part, alleging that the General Court substituted its own assessment for that of the Commission.
C. Conclusion on the appeal
336 Since the seven grounds of appeal have been upheld, the judgment under appeal must be set aside.
VII. The consequences of setting aside the judgment under appeal
337 In accordance with the first paragraph of Article 61 of the Statute of the Court of Justice of the European Union, the Court of Justice may, where it sets aside the decision of the General Court, either itself give final judgment in the matter, where the state of the proceedings so permits, or refer the case back to the General Court for judgment.
338 In the present case, as regards the pleas in law of the action at first instance seeking annulment of Article 4 of the decision at issue, which relates to the infringement of Article 101 TFEU, the Court considers that the state of the proceedings does not permit final judgment to be given on the matter in its entirety. By the fourth plea in law of its action at first instance, Krka claims that the Commission contradicted itself in the reasoning of the decision at issue and made several errors in characterising the Krka assignment and licence agreement as a restriction of competition by object. As is apparent from paragraph 280 of the present judgment, the General Court invalidated that characterisation – on the sole ground that it had rejected the same characterisation in relation to the Krka settlement and licence agreements – without, however, ruling on the substance of that fourth plea. The case must therefore be referred back to the General Court for judgment on the fourth plea in law of the action at first instance relating to the characterisation of the Krka assignment and licence agreement as a restriction of competition by object within the meaning of Article 101(1) TFEU.
VIII. The action before the General Court
339 In the context of its action at first instance, by its first and second pleas Krka disputes the existence of potential competition with Servier. By its third plea, it disputes the characterisation of the Krka settlement agreement as a restriction of competition by object. By its fifth plea, it disputes the characterisation of the Krka agreements as a restriction of competition by effect. By its sixth plea, it criticises the Commission for failing to find that those agreements were covered by the exemption under Article 101(3) TFEU.
340 In the light, in particular, of the fact that those pleas were the subject of an exchange of arguments before the General Court and that their examination does not require the adoption of any additional measure of organisation of procedure or inquiry, the Court of Justice considers that the state of the proceedings permits final judgment to be given in respect of the pleas in question.
A. The first to third pleas in law at first instance, relating to the characterisation of the Krka settlement and licence agreements as a restriction of competition by object
341 By its first and second pleas, Krka disputes, in essence, the existence of actual or potential competition between it and Servier. By its third plea, Krka denies that the Krka licence agreement may have induced it to conclude the Krka settlement agreement, and disputes the claim that those agreements can be compared to a market-sharing agreement and characterised as a restriction of competition by object. Accordingly, the arguments developed in respect of those three pleas relate either to whether Krka was an actual or potential competitor of Servier at the time of the conclusion of the Krka settlement and licence agreements, notwithstanding the successive legal defeats suffered by Krka in its attempts to have the 947 patent invalidated, or to whether those agreements, taken together, constituted a market-sharing agreement falling within the characterisation of a restriction of competition by object within the meaning of Article 101(1) TFEU.
342 In accordance with what has been held in paragraph 93 of the present judgment, it is necessary to ascertain, first of all and in so far as Krka raised that question before the General Court, whether the Commission was entitled to characterise the Krka agreements as a restriction of the potential competition exerted by Krka on Servier. To that end, it is necessary to examine whether, on the date on which the Krka settlement and licence agreements were concluded, there were real and concrete possibilities for Krka to enter the perindopril market and compete with Servier. That examination requires that it be determined whether Krka had taken sufficient steps for it to be established that it had the firm intention and inherent ability to enter the market within a period of time capable of putting competitive pressure on Servier, and that it be verified that there were no insurmountable barriers to that entry, bearing in mind that any finding of potential competition can, where appropriate, be confirmed by additional factors.
343 If that is the case, it will then be necessary to determine, secondly, in accordance with what has been held in paragraphs 74 and 75 of the present judgment, whether the Krka settlement and licence agreements constituted a market-sharing agreement which restricted competition by object within the meaning of Article 101(1) TFEU, as the Commission found to be so in the decision at issue. To that end, it will be necessary to examine the objectives of those agreements and the economic link which, according to the decision at issue, existed between them. More specifically, it will be necessary to assess whether the transfer of value by Servier to Krka, by means of the Krka licence agreement, was sufficiently significant to induce Krka to agree to share the national markets for perindopril with Servier, by refraining, even if only temporarily, from entering Servier’s core markets in return for the assurance that it would be able to market its generic version of perindopril on its own core markets, without incurring the risk that it would be the subject of infringement actions brought by Servier. Lastly, it will be necessary to take into account, in so far as Krka raises that issue in a relevant manner, the intentions of the parties to the Krka agreements, since they can help establish the objective aims that those agreements were intended to achieve.
1. The potential competition exerted by Krka on Servier
(a) Arguments of the parties
344 By its first and second pleas in law, Krka disputes, in essence, the findings made in the decision at issue as regards the existence, on the date on which the Krka settlement and licence agreements were concluded, of potential competition exerted by Krka on Servier.
345 In the first place, Krka submits that the Commission failed properly to analyse the legal, factual and economic context.
346 Krka recalls that its initial strategy consisted in developing a generic version of perindopril falling within the scope of the protection resulting from the 947 patent. The EPO decision of 27 July 2006 shattered its hopes of that patent being revoked. Not believing that it would succeed, on appeal, in persuading the EPO Boards of Appeal to overturn that decision, Krka then resigned itself to accepting the validity of that patent. Accordingly, on the date on which the Krka settlement and licence agreements were concluded, Servier, as can be seen from recital 2572 of the decision at issue, held several patents, thereby preventing Krka from marketing its perindopril, on account of the risk that it would be the subject of infringement proceedings and of the costs associated with such a commercial strategy.
347 Krka alleges that the Commission ignored at least three essential factors.
348 First, the Commission failed to take into account the fact that Krka’s perindopril infringed the 947 patent. That medicinal product was in fact the only one available to Krka, as the Commission, according to Krka, expressly acknowledged in recitals 822, 827 to 829, 834, 1675, 2674, 2690, 2815 and 2862 of the decision at issue.
349 Second, the Commission overlooked the fact that the EPO decision of 27 July 2006 adversely affected Krka’s relations with its potential customers. Thus, following that decision, Ratiopharm informed Krka that it no longer intended to launch Krka’s perindopril on the markets in France and the United Kingdom and on other smaller markets.
350 Third, the Commission ignored the fact that, after the EPO decision of 27 July 2006, Krka decided to cease all activity associated with its perindopril as a result of its infringing nature, as the minutes of Krka’s internal meetings, in particular those of 13 and 14 September 2006, attest. Krka states that it immediately embarked on research with a view to developing a non-infringing version of perindopril.
351 In the second place, Krka asserts that, in the light of those factors, on the date on which the Krka settlement and licence agreements were concluded, it was not a potential competitor of Servier. The decision at issue is based on hypothetical, unrealistic and unsupported considerations.
352 The Commission’s assessment is incorrect in so far as it finds, in recitals 1675 and 1693 of the decision at issue, that after the EPO decision of 27 July 2006, Krka continued to market its perindopril and brought legal proceedings in the United Kingdom. Krka notes that it was Servier that took the initiative to bring infringement proceedings in the United Kingdom. By filing a counterclaim, Krka acted as a prudent business owner, even though it was not successful. Krka asserts that if it did not immediately withdraw from the proceedings between it and Servier and cease marketing its perindopril, this was because it needed time to develop its plans for marketing a generic version of perindopril and for strategic reasons intended to improve its position in negotiations with Servier with a view to reaching a settlement. The Commission furthermore confirmed indirectly, according to Krka, in recital 2756 of the decision at issue, that Krka was not a potential competitor on the date on which the Krka settlement and licence agreements were concluded.
353 The Commission disputes those arguments.
(b) Findings of the Court
354 As a preliminary point, it should be recalled that the existence of an infringement of the competition rules can only be correctly determined if the evidence upon which the contested decision is based is considered, not in isolation, but as a whole, account being taken of the specific features of the market of the products in question (judgment of 14 July 1972, Imperial Chemical Industries v Commission, 48/69, EU:C:1972:70, paragraph 68). The scope of judicial review provided for in Article 263 TFEU extends to all the elements of Commission decisions relating to proceedings under Articles 101 and 102 TFEU, in respect of which it is necessary to ensure an in-depth review, in law and in fact, in the light of the pleas raised by the parties (judgments of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraph 44, and of 21 January 2016, Galp Energía España and Others v Commission, C‑603/13 P, EU:C:2016:38, paragraph 72).
355 According to recitals 1672 to 1700 of the decision at issue, Krka was the first manufacturer of generic medicines to challenge Servier’s position on the perindopril market. Those two undertakings were already actual competitors on the markets in the Czech Republic, Lithuania, Hungary, Poland and Slovenia, where Krka had started marketing a generic version of perindopril. On the other national markets within the European Union, Krka was a potential competitor of Servier. Krka was preparing its entry to those other markets by means of concrete and sufficient steps, having, inter alia, obtained marketing authorisations in France, the Netherlands and the United Kingdom, and already had a product ready to be launched. On some of those other markets, it benefited from cooperation from commercial partners. The Commission found, in recital 1685 of that decision, that it was apparent from numerous items of documentary evidence predating the EPO decision of 27 July 2006 that Krka was at that time confident of success in proceedings between Krka or its commercial partners and Servier concerning the validity of the 340 and 947 patents.
356 Thus, according to the decision at issue, before the conclusion of the Krka settlement and licence agreements, Krka was already competing with Servier on certain national markets and, on those where it was not yet present, it not only had the ability to enter within a short period of time, but also had the firm intention of doing so. In the light of those factors, Krka could be considered to be a potential competitor of Servier.
357 Krka does not dispute those factors as such, but submits that the Commission could not consider that, at the time the Krka settlement and licence agreements were concluded, it could still be considered to be a potential competitor of Servier. Krka complains, in essence, that the Commission distorted the intentions of the parties, and more particularly those of Krka, by refusing to accept that the series of court defeats which Krka had suffered convinced it that the 947 patent was valid and that it was therefore preferable for it to negotiate with Servier with a view to obtaining a licence for that patent on its core markets. It also states that the EPO decision of 27 July 2006 had adversely affected its relations with its potential customers.
358 In the present case, in order to determine whether Krka is justified in claiming that, on account of the EPO decision of 27 July 2006 and the decision of the High Court of 3 October 2006, it no longer had the ability or the firm intention to enter Servier’s core markets, and therefore no longer constituted a source of potential competition, it should be borne in mind that the existence of a patent which protects the manufacturing process of an active ingredient that is in the public domain cannot, as such, be regarded as an insurmountable barrier, and does not mean that a manufacturer of generic medicines who has in fact a firm intention and an inherent ability to enter the market, and who, by the steps taken, shows a readiness to challenge the validity of that patent and to take the risk, upon entering the market, of being subject to infringement proceedings brought by the patent holder, cannot be characterised as a potential competitor of the manufacturer of originator medicines concerned (judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 46). Furthermore, as held in paragraph 94 of the present judgment, where disputes between them on the question of the validity of the patent in question are still pending, it is necessary to examine all the relevant evidence before reaching the conclusion that the patent holder and such a manufacturer of generic medicines are not potential competitors.
359 Admittedly, Ratiopharm, a potential customer of Krka with a view to an entry into certain of Servier’s core markets, informed Krka, following the EPO decision of 27 July 2006, that it was not prepared to launch Krka’s perindopril on those markets ‘as long as the [947] patent is upheld’. Although that decision by a third-party undertaking not to envisage an ‘at risk’ entry into those markets undoubtedly made such an entry more difficult for Krka, it is nevertheless clear from the elements relied on by the Commission, construed as a whole, that that fact did not cause Krka to abandon its plan to enter Servier’s core markets with its perindopril as soon as possible.
360 Indeed, as regards Krka’s firm intention to continue its efforts to market its perindopril, and the question whether the legal defeats suffered by Krka constituted an insurmountable barrier to its entry within a period of time capable of putting competitive pressure on Servier on the latter’s core markets, for the purpose of the case-law referred to in paragraph 68 of the present judgment, it is apparent from the evidence cited by the Commission in recitals 1686 to 1691 of the decision at issue that neither the EPO decision of 27 July 2006 nor the decision of the High Court of 3 October 2006 prompted Krka to cease its efforts to enter those markets. Furthermore, during that period, as is apparent from recitals 1687 and 1700 of the decision at issue, which Krka does not dispute, Krka succeeded in obtaining, in Hungary, in September 2006, the rejection of Servier’s application for interim measures relating to the 947 patent, whereas Krka already marketed, on the Hungarian market, its perindopril composed of the alpha crystalline form of erbumine protected by the 947 patent.
361 More specifically, in recitals 1687 and 1688 of the decision at issue, the Commission referred to documents showing, on the contrary, that Krka was critical of the EPO decision of 27 July 2006 and determined not to resign itself to it. It follows, inter alia, from the testimony of one of Krka’s employees, quoted in full in recitals 895 and 1688 of that decision, that ‘especially what bothers us is that the trial was discriminative against [the] generic industry and we shall not let them go just like that’. Such an assertion, made on behalf of Krka, casts doubt on the claim that Krka had given up on challenging the validity of the 947 patent with a view to being able to enter Servier’s core markets. In addition, the specific actions taken by Krka after the EPO decision of 27 July 2006 confirm that that undertaking had not accepted the validity of that patent, since it continued to challenge its validity before the EPO and, on 1 and 8 September 2006, filed counterclaims against Servier for invalidity of the 947 and 340 patents in the context of the infringement proceedings brought by Servier in the United Kingdom.
362 Moreover, no document contemporaneous with the Krka settlement and licence agreements indicates that the EPO decision of 27 July 2006 and the decision of the High Court of 3 October 2006 changed Krka’s perception of the validity of the 947 patent to such an extent as to lead it to abandon its marketing plans for its own perindopril. In particular, Krka’s internal documents, dated 13 and 14 September 2006, to which that undertaking refers, and according to which the activities relating to Krka’s perindopril were to cease in favour of work on the development of a non-infringing version of that medicinal product, cannot be interpreted as reflecting a strategic decision of Krka’s management. As the Commission stated in recital 1687 of the decision at issue, those internal documents merely recorded views expressed at operational meetings within that undertaking’s Research and Development Department, whose interpretation by Krka is, in any event, contradicted by the fact that that undertaking continued producing its perindopril, composed of the alpha crystalline form of erbumine protected by the 947 patent, as demonstrated by the same internal documents of Krka, as the Commission noted in footnote 2260 to that decision.
363 It is true that Krka submits, in essence, that the filing of a counterclaim before the United Kingdom court hearing proceedings brought by Servier and the continuance of its activities relating to the marketing of its generic version of perindopril could be explained by legitimate commercial objectives, that is to say, by the obligation to act diligently to protect its interests and by its wish to strengthen its negotiating position vis-à-vis Servier. However, those allegedly legitimate commercial objectives are not relevant to assessing the existence of potential competition between Krka and Servier but solely, if applicable, to assessing the object of the Krka settlement and licence agreements. Indeed, while, by those claims, Krka confines itself to invoking factors relating to its intention, those claims are not such as to cast doubt on the fact that, notwithstanding its court defeats, Krka had not put an end to its plans to market a perindopril composed of the alpha crystalline form of erbumine protected by the 947 patent.
364 In any event, in the light of the evidence to the contrary relied on by the Commission in recitals 1686 to 1691 of that decision, those internal documents do not convincingly establish that Krka, as that undertaking asserts, definitively abandoned its intention to enter Servier’s core markets with that perindopril following the EPO decision of 27 July 2006. That evidence shows objectively that Krka continued to have an inherent ability to gain access to Servier’s core markets and the intention of entering those markets.
365 In so far as Krka complains that the Commission ‘distorted’ the parties’ intentions, it should be borne in mind that the Commission acknowledged, in recitals 1688 and 1690 of the decision at issue, that Krka was no longer so firmly convinced of the strength of its litigation position following the EPO decision of 27 July 2006 and that it was in reaction to that decision that Krka had taken the initiative of contacting Servier in order to consider the possibility of Servier granting it a licence under the 947 patent for certain geographic markets.
366 However, nor does that initiative show that Krka had decided not to compete with Servier on the latter’s core markets by means of its perindopril composed of the alpha crystalline form of erbumine protected by the 947 patent. As is apparent from the evidence relied on by the Commission in recitals 912 and 1688 of the decision at issue, Krka was aware that Servier had agreed to negotiate with it following the EPO decision of 27 July 2006 because it represented ‘a serious threat’ to Servier, which ‘believed that Krka had [some] of the best and most comprehensive evidence in the opposition before the EPO and in [the] UK revocation’. It follows that the existence of the dispute between Krka and Servier concerning the validity of the 947 patent, which was the subject of proceedings pending before the EPO and in the United Kingdom and which those two undertakings regarded as serious, constitutes further evidence of the potential competitive relationship between them (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 52), that competition being, moreover, likely to crystallise within a period of time capable of putting competitive pressure on Servier within the meaning of the case-law cited in paragraph 68 of the present judgment. That is necessarily the case since the existence of that competition actually influenced Servier’s commercial conduct by leading it to grant a licence to Krka on Krka’s core markets.
367 It should be recalled in that regard that the conclusion of an agreement between a number of undertakings, operating at the same level in the production chain, some of which have no presence in the market concerned, constitutes a strong indication that a competitive relationship exists between those undertakings (judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 55 and the case-law cited).
368 If the fact that Krka negotiated with Servier with the aim of concluding agreements such as the Krka settlement and licence agreements was sufficient to demonstrate that Krka no longer had the firm intention to compete with Servier by means of its perindopril composed of the alpha crystalline form of erbumine protected by the 947 patent, or even that there was an insurmountable barrier to such entry to Servier’s core markets, notwithstanding the existence of objective evidence such as that cited by the Commission in recitals 1686 to 1691 of the decision at issue, that would mean, contrary to the case-law recalled in the previous paragraph, that the decision of an undertaking to negotiate and then conclude an agreement with another undertaking operating at the same level of the production chain, with the aim of substituting cooperation for competition on the merits, could result in it no longer being a potential competitor of the other party to the contract. If that were the case, the deliberate choice of an undertaking to pursue a commercial policy consisting in concluding an agreement having an anticompetitive object could remove that agreement from the scope of the prohibition laid down in Article 101(1) TFEU and thus deprive that provision of a significant part of its effectiveness.
369 As regards Krka’s argument that the Commission indirectly confirmed, in recital 2756 of the decision at issue, that Krka was not a potential competitor of Servier on the perindopril market on the date on which the Krka settlement and licence agreements were concluded, it should be noted that that recital does not form part of the analysis of such potential competition for the purposes of the application of Article 101 TFEU, but relates to whether Servier held a dominant position on the market for the technology relating to the active ingredient of that medicinal product, for the purposes of the application of Article 102 TFEU. Accordingly, although there is no requirement to rule in the present judgment on the validity of the information referred to in that recital, it must be found that that argument cannot call into question the considerations set out in paragraphs 358 to 368 of the present judgment.
370 In the light of the foregoing, Krka’s line of argument does not invalidate the Commission’s finding, in recital 1700 of the decision at issue, that, on the date the Krka settlement and licence agreements were concluded, Krka was a potential competitor of Servier.
371 The first and second pleas in law of Krka’s action at first instance must therefore be rejected.
2. The existence of a market-sharing agreement
(a) Arguments of the parties
372 By the first part of the third plea in law of its action at first instance, Krka submits that the Commission erred in the factual and legal analysis of the Krka settlement and licence agreements.
373 In the first place, after reiterating that, on the date on which those agreements were concluded, it was not an ‘at least’ potential competitor of Servier, Krka disputes the Commission’s finding that the Krka licence agreement served to induce Krka to conclude the Krka settlement agreement.
374 First of all, the licence agreement was not the quid pro quo for the settlement agreement. The Krka settlement agreement did not in fact involve any financial quid pro quo from Servier to Krka.
375 Next, the Krka licence agreement was concluded at arm’s length. It was an ordinary patent licence. Krka disputes the estimate, given in recital 1738 of the decision at issue, putting the value of that licence agreement at EUR 10 million, since such an estimate was speculative. According to Krka, the Krka licence agreement was a commercial agreement with ordinary consideration, under which both parties had rights and obligations, with no transfer of value.
376 Lastly, the existence of a market-sharing agreement is refuted by the fierce competition between Servier and Krka on Krka’s core markets, as the Commission moreover stated in recitals 1725 and 2350 of the decision at issue. The fact that the Krka licence agreement granted Krka an exclusive licence on its core markets, according to Krka, reflects the existence of rights held by Servier as holder of the 947 patent.
377 Furthermore, Krka asserts that it did not refrain from entering Servier’s core markets in return for the Krka licence agreement. It repeats that that entry was impossible as a result of the 947 patent. Krka disputes the Commission’s interpretation of Krka’s own statements, in recitals 1746 and 1751 of the decision at issue. Contrary to that institution’s claims, Krka did not offer Servier a ‘withdrawal from competition’ but a settlement of the disputes relating to the 947 patent. In Krka’s view, Lupin’s statement, referred to in recital 1730 of the decision at issue, according to which it ‘would seem the rationale for [the Krka settlement agreement] from Servier’s view is that it protects the key markets where high level substitution and/or [international non-proprietary name] prescribing is prevalent’, was not communicated to it, is irrelevant and has no probative value.
378 The Krka settlement agreement had the effect not of restricting but of increasing competition. The Krka licence agreement enabled Krka, on its core markets, to compete with Servier. The Commission ignored the fact that patent licence agreements are inherently procompetitive, as is apparent from Regulation No 772/2004 and from the Guidelines on the application of Article 101 TFEU to technology transfer agreements, referred to in paragraph 213 of the present judgment.
379 Krka submits that its acceptance of the Krka settlement agreement is explained not by the conclusion of the Krka licence agreement but by the fact that from that time it recognised the validity of the 947 patent. The EPO decision of 27 July 2006 and the decision of the High Court of 3 October 2006 in fact convinced it that it was essential to end to the disputes between it and Servier in relation to the validity of that patent and the infringing nature of Krka’s perindopril.
380 Krka states that the Krka settlement agreement did not lead it to abandon its plan to enter the perindopril markets. The EPO decision of 27 July 2006 did indeed lead it to abandon the marketing of its perindopril, composed of the alpha crystalline form of erbumine protected by the 947 patent, on account of its infringing nature. That decision, it asserts, gave it an incentive to develop that medicinal product in a non-infringing form, for which it obtained marketing authorisations from 2009.
381 In the second place, Krka denies that the Krka settlement agreement restricts competition. That agreement did not in its view fall within the prohibition provided for in Article 101(1) TFEU, because according to Krka it pursued the legitimate objective of settling genuine disputes with Servier. That agreement was concluded not in return for the grant of a licence under the 947 patent but because Krka recognised the validity of that patent. Furthermore, that agreement did not lay down any restrictions on Krka’s commercial activities affecting non-infringing forms of perindopril or the active ingredient of that medicinal product.
382 Krka submits in that respect that the non-challenge and non-marketing clauses contained in the Krka settlement agreement did not restrict competition. According to Krka, the sole and legitimate objective of those clauses was to end the disputes between it and Servier. If those clauses prevented the marketing of perindopril composed of the alpha crystalline form of erbumine protected by the 947 patent, it was only because it was an infringing medicinal product.
383 In respect of the non-challenge clause, Krka asserts that the statement of reasons in the decision at issue is contradictory. On the one hand, that decision states that the clause in question restricts competition whereas, on the other, it acknowledges, in recital 1133, that the parties to a patent dispute are entitled to conclude a settlement agreement notwithstanding the utility of having a judicial decision.
384 The Commission’s assertion that the non-challenge clause in question had the effect of preventing an objective review of the validity of the 947 patent is incorrect because Krka’s discontinuance had no effect on the continuance of the court proceedings by the other parties to those proceedings.
385 By the second part of the third plea in law of its action at first instance, Krka submits that the Commission failed properly to examine the economic and legal context of the Krka settlement agreement, since it failed to take into consideration the nature of the goods affected, the real conditions of the functioning of the market or the structure of that market.
386 By the third part of the third plea in law of its action at first instance, Krka submits, in the alternative, that, even if the Krka licence agreement had constituted the quid pro quo for the Krka settlement agreement, the latter agreement did not infringe competition law, whether in the light of the criteria laid down, in United States law, by the judgment of the Supreme Court of the United States of 17 June 2013, Federal Trade Commission v. Actavis (570 U.S. (2013)), or, in EU law, by the Commission in the decision at issue.
387 As regards the latter criteria, Krka notes that it is clear from recital 1102 of the decision at issue that transfers of value are envisaged within a unilateral relationship, passing from the manufacturer of originator medicines to the manufacturer of the generic medicine. However, in the present case, the Commission asserted that the Krka licence agreement was the quid pro quo for the Krka settlement agreement. That assertion amounts to finding that those agreements gave rise to reciprocal transfers of value. Accordingly, in order to show that there was a net transfer of value to Krka, making it possible to conclude that there was an infringement of competition law, the Commission would have had to show that Servier’s gain on its core markets was smaller than Krka’s gain on its own core markets.
388 Furthermore, according to Krka, the Commission failed to establish, in the decision at issue, that the Krka settlement and licence agreements had the effect of reducing the incentive for Krka to continue its efforts to market its own perindopril. However, the Commission ignored the fact that Krka remained at liberty to develop a non-infringing form of that medicinal product. The Commission disregarded the fact that, after the EPO decision of 27 July 2006, Krka did not believe that it had any chance of obtaining the revocation of the 947 patent, and the fact that the Krka licence agreement had procompetitive effects on Krka’s core markets.
389 The Commission disputes those arguments.
(b) Findings of the Court
390 Krka asserts that the Krka settlement and licence agreements were concluded because of the recognition of the validity of the 947 patent and were aimed at finding a solution to the disputes between it and Servier in relation to the 947 patent.
391 However, by that line of argument, Krka is in essence merely reiterating its claims alleging recognition of the validity of that patent, relating to the absence of potential competition exerted by Krka and to the existence of an agreement to share markets. Those arguments have already been rejected for the reasons set out in paragraphs 355 to 370 and paragraphs 141 to 147 respectively, of the present judgment.
392 By its remaining arguments, Krka disputes, in essence, the existence of a market-sharing agreement whereby Krka refrained from entering Servier’s core markets in return for the establishment of a de facto duopoly on Krka’s core markets.
393 Since Krka relies on the allegedly ‘legitimate’ nature of the clauses of the Krka settlement and licence agreements, it should be noted at the outset that, although the objective aims that agreements are intended to achieve from a competition standpoint are relevant to determining whether they may have an anticompetitive object, the fact that the undertakings involved acted without having an intention to prevent, restrict or distort competition and the fact that they pursued certain legitimate objectives are not decisive for the purposes of the application of Article 101(1) TFEU (judgment of 21 December 2023, European Superleague Company, C‑333/21, EU:C:2023:1011, paragraph 167 and the case-law cited). Accordingly, the fact that a commercial strategy under which undertakings operating at the same level of the production chain negotiate such agreements between them in order to put an end to a dispute relating to the validity of a patent is logical and rational from the point of view of those undertakings in no way demonstrates that the pursuit of that strategy is justifiable from the point of view of competition law.
394 Furthermore, it is indeed true, as has been held in paragraph 189 of the present judgment, that patent dispute settlement agreements, like licence agreements associated with such agreements, may be concluded with a legitimate aim and entirely lawfully on the basis of the parties’ recognition of the validity of the patent in question. Moreover, settlement agreements are encouraged by the public authorities in that they make possible savings in terms of resources and are thus beneficial for the public at large (judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 79). Similarly, as Krka rightly points out in its application at first instance, it is undeniable that a licence agreement allowing a manufacturer of generic medicines to enter certain markets which are closed to competition because of the existence of a patent is likely, by definition, to produce procompetitive effects on those markets.
395 However, as is apparent from the case-law referred to in paragraph 189 of the present judgment, the fact that agreements pursue an objective which, in the abstract, may be legitimate cannot exclude those agreements from the application of Article 101 TFEU if it is established that those agreements also have the aim of sharing markets or restricting competition in other ways. Furthermore, as has been recalled in paragraphs 141 to 147 of the present judgment, the fact that an agreement takes a legal form which is in principle legitimate and that the wording of that agreement does not reveal an apparent anticompetitive object is not, in itself, decisive in determining whether the agreement gives rise to an infringement of Article 101(1) TFEU. Every agreement must be assessed in the light of its specific content and its economic context, and in particular in the light of the situation on the market concerned.
396 In the present case, the arguments put forward by Krka in the context of its third plea in law at first instance, which relate to the content of the Krka settlement and licence agreements, disregard, in the first place, the fact that the links between those agreements are such that it was essential to examine their clauses not in isolation, but as forming a whole. In the second place, those arguments do not take account of the fact that the Krka licence agreement authorised Krka to market its perindopril, composed of the alpha crystalline form of erbumine protected by the 947 patent, on its core markets, to which the infringement of Article 101(1) TFEU found in the decision at issue does not relate, whereas the settlement agreement prohibited Krka from marketing that medicinal product on Servier’s core markets, to which that infringement does relate.
397 As regards the links between the Krka settlement and licence agreements, it is clear from the wording of those agreements and the circumstances surrounding their conclusion, as reported by the Commission in recital 1703 of the decision at issue, that, economically, those agreements are connected in the sense that, as the Commission noted in recital 1702 of that decision, one could not have been concluded in the absence of the other. Moreover, that connection is demonstrated by the documentary evidence relied on by the Commission in recitals 1746 and 2103 of the decision at issue, from which it is apparent that Krka considered that the Krka licence agreement was a prerequisite for agreeing to refrain from entering Servier’s core markets, since the restrictions laid down in the Krka settlement agreement were indispensable in order to obtain that licence. Thus, in so far as Krka seeks, without disputing the existence of those links as such, to call into question the Commission’s analysis of those agreements on the basis of a line of argument which examines those agreements separately in order to establish the allegedly legitimate nature of their content, that line of argument is based on a false premiss. It also follows, as has been held in paragraph 157 of the present judgment, and contrary to Krka’s line of argument, that, irrespective of whether or not the level of the royalty provided for in the Krka licence agreement was appropriate in the light of market conditions, it was the access to its core markets without risk of patent infringement that led Krka to refrain from selling its perindopril, composed of the alpha crystalline form of erbumine protected by the 947 patent, on Servier’s core markets.
398 Moreover, Krka’s argument based on the allegedly procompetitive nature of the Krka licence agreement on Krka’s core markets is undermined by the fact that that agreement does not cover Servier’s core markets, which are the only ones to which the infringement of Article 101(1) TFEU found in the decision at issue relates. That procompetitive nature, even if it were established, would have a positive impact on competition only on Krka’s core markets. In any event, although the grant of a licence on certain markets in return for an undertaking by the licensee not to challenge the validity of the patent of the other contracting party in relation to those markets may, subject to an assessment of its specific content and economic context, be regarded as legitimate from a competition perspective, the same is not true where a set of agreements allows that licensee to enter certain geographic markets without risk of patent infringement while at the same time prohibiting it from entering other markets.
399 Such a set of agreements entails, in principle, a sharing of those markets and, therefore, a restriction of competition by object, which cannot be put into context or offset by any positive or procompetitive effects on any market whatsoever. The Commission is not to examine the effects of an agreement or of conduct in the context of its assessment of whether there may be a restriction of competition by object (see, to that effect, judgment of 21 December 2023, European Superleague Company, C‑333/21, EU:C:2023:1011, paragraphs 159 and 166 and the case-law cited).
400 Furthermore, as the Commission explained in recital 1745 of the decision at issue, it is precisely because the Krka licence agreement and the non-infringement obligation arising from the Krka settlement agreement do not cover the same national markets that, in its view, that licence agreement was not legitimate but, rather, constituted a significant economic incentive for Krka to accept the restrictions set out in the Krka settlement agreement and, therefore, to share those markets geographically with Servier. That quid pro quo is therefore comparable, from an economic point of view, to a transfer of value within the meaning of the case-law referred to in paragraph 71 of the present judgment. In order to determine whether that analysis is well founded, it is necessary, in accordance with that case-law, to assess whether that transfer of value from Servier to Krka can be explained solely by Servier and Krka’s interest in not engaging in competition on the merits.
401 In that regard, as has been recalled in paragraphs 355 and 356 of the present judgment, not only did Krka already sell its perindopril on some of its core markets but, in addition, it was ahead of Servier’s potential competitors in its plans for marketing a generic version of perindopril, in particular in France and the United Kingdom, two of Servier’s core markets. Furthermore, it is apparent from the data relating to the sales of perindopril in, inter alia, recitals 2273 to 2401 of the decision at issue that the price at which Servier sold that medicinal product on the markets in France, the Netherlands and the United Kingdom was much higher than that at which Krka sold its perindopril on the market in Poland. In those circumstances, Servier’s incentive to delay the entry of that medicinal product to its core markets was obvious and has not, moreover, been disputed.
402 As regards the question whether the Commission was entitled to take the view that the Krka licence agreement constituted consideration for the Krka settlement agreement, it must be borne in mind, first of all, that the Krka licence agreement granted Krka, exclusively and irrevocably, the rights to the 947 patent on Krka’s core markets, notwithstanding the possibility that Servier had reserved for itself of also exploiting those rights, directly or through its subsidiaries, or through one third party only per country. It follows from that arrangement that, on each of those markets, apart from Servier, its subsidiaries or a third party designated by it, Krka was the only undertaking able to market perindopril composed of the alpha crystalline form of erbumine protected by the 947 patent without risking infringement of that patent.
403 Next, as the Commission observed in recitals 1721, 1724, 1728 to 1730 and 1819 of the decision at issue, Servier’s decision not to oppose the marketing by Krka, on Krka’s core markets, of a generic version of perindopril amounts, from an economic point of view, to a transfer of value to Krka. As a result of such a quid pro quo, Servier and Krka were each able to maintain a more favourable position on their respective core markets, Servier having succeeded in eliminating the potential competition resulting from the entry of Krka’s perindopril, composed of the alpha crystalline form of erbumine protected by the 947 patent, on its core markets and Krka having obtained the certainty that it would be able to market that medicinal product on its own core markets, without risk of patent infringement.
404 In that context, Krka denies that it refrained from entering Servier’s core markets in return for the Krka licence agreement. However, it follows from the evidence relied on by the Commission in recitals 913 and 1748 of the decision at issue that Krka itself indicated to the Commission, on 4 August 2009, in response to a request for information from that institution, that it had ‘sacrificed’ Servier’s core markets, which ‘were less significant for Krka’, ‘[in return] for getting immediate access to markets in [central and eastern Europe]’. Without its being necessary to rule on Krka’s complaint relating to the relevance of the statement by Lupin referred to in recital 1730 of the decision at issue, it therefore follows from the evidence in the file before the Court of Justice that the prospect thus offered to Krka of being the only manufacturer of a generic version of perindopril on its core markets was preferable, from Krka’s subjective point of view – even if it had not refrained from entering Servier’s core markets in the absence of the grant of a licence covering its own core markets – to the prospect of legal proceedings on Servier’s core markets which were likely to be costly, the outcome of which was uncertain and which, if successful, would have benefited all the manufacturers of generic medicines, as the Commission found in recitals 844, 874, 914, 1759 and 1763 of the decision at issue.
405 In respect of Krka’s argument that the Commission downplayed the extent of the competition between it and Servier on Krka’s core markets, it should be noted that, although, in recitals 1728 and 1744 of the decision at issue, the Commission did not deny the existence of a certain degree of competition, the precise degree of competition on those markets is irrelevant because it does not alter the fact that Servier necessarily renounced market shares, and therefore part of its profits, in favour of Krka.
406 As regards Krka’s line of argument in the alternative, to the effect that Krka’s renunciation of Servier’s core markets can be analysed as a transfer of value from Krka to Servier, so that the present case concerns two reciprocal transfers of value, it is sufficient to note that that line of argument ignores the fact, noted in paragraphs 398 and 399 of the present judgment, that an arrangement such as that comprising the Krka settlement and licence agreements is restrictive of competition by object where that arrangement objectively results in a geographic division of the national markets.
407 As regards the question whether the transfer of value referred to in paragraph 403 of the present judgment was sufficiently significant to have induced Krka to conclude the Krka settlement agreement, it is apparent from recital 1738 of the decision at issue that Krka itself assessed the economic value thus transferred by Servier in return for its undertaking not to enter Servier’s core markets at approximately EUR 10 million over a period of three years. That estimate proved to be reliable since, as is apparent from the evidence in the file cited in footnote 4112 to that decision, during the term of the Krka settlement and licence agreements, Krka’s profits from the sale of perindopril on the markets in Hungary, Poland and the Czech Republic alone amounted to EUR 10 million. Even if the annual royalty payable by Krka to Servier under the Krka licence agreement is deducted from that amount of EUR 10 million, the fact remains that such a substantial transfer of value from Servier to Krka cannot be explained by any consideration from Krka other than its undertaking not to engage in competition with Servier on its core markets.
408 Krka asserts that it was prohibited from marketing its perindopril, composed of the alpha crystalline form of erbumine protected by the 947 patent, on Servier’s core markets, on account of its purportedly infringing nature, but that it remained free to market a non-infringing version of that medicinal product, which it was, moreover, in the process of developing. However, it is sufficient to note, in that regard, that the fact that a market-sharing agreement limits the opportunities for a potential competitor to compete with the patent holder without, however, completely ruling out the possibility that that competitor will compete in the long term by developing a non-infringing product, cannot invalidate the conclusion that such an agreement constitutes a restriction of competition by object.
409 As regards Krka’s line of argument that the Krka settlement agreement did not prevent Servier’s other potential competitors from pursuing their actions seeking to invalidate the 947 patent, it must be held that such a circumstance cannot justify, in the light of competition law, the fact that that agreement required Krka to abandon the ongoing litigation between it and Servier in that regard. That is all the more true since, as is apparent from the evidence referred to in paragraph 366 of the present judgment, Servier ‘believed that Krka had [some] of the best and most comprehensive evidence in the opposition before the EPO and in [the] UK revocation’, which means that the withdrawal of its legal actions was liable significantly to reduce the chances that that patent would be invalidated and therefore to strengthen the control that Servier could exert on the relevant markets.
410 It should be added, so far as this point is relevant, to the extent that Krka seeks, by some of its arguments, to downplay the degree of harmfulness of the Krka agreements, that there is no doubt that the restriction of competition found by the Commission was sufficiently harmful to be classified as a restriction of competition by object, within the meaning of the case-law of the Court of Justice (see, by analogy, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 67 and the case-law cited). As is apparent from the case-law referred to in paragraph 64 of the present judgment, agreements which aim to share markets have, in themselves, an object restrictive of competition and fall within a category of agreements expressly prohibited by Article 101(1) TFEU.
411 The assessment of all of the parties’ arguments and of the evidence in the file therefore leads to the conclusion that the Commission did not make a manifest error of assessment in finding, in recital 1745 of the decision at issue, that, although a patent licence may be a legitimate means for the holder of that patent to grant a third party the right to exploit the invention protected by that patent, the Krka licence agreement had served as an inducement to obtain Krka’s undertaking to refrain from entering Servier’s core markets, thus allowing those two undertakings to organise market sharing between themselves.
412 The third plea in law of Krka’s action at first instance must therefore be rejected and it must be held that Krka has not succeeded in invalidating the characterisation in the decision at issue of the practice relating to Servier and Krka’s sharing the perindopril market by means of the Krka settlement and licence agreements as a restriction of competition by object.
B. The fifth plea in law at first instance, relating to the existence of a restriction of competition by effect within the meaning of Article 101(1) TFEU
1. Arguments of the parties
413 By its fifth plea in law at first instance, Krka disputes the Commission’s assessment, in recital 1813 et seq. of the decision at issue, concerning the characterisation of the Krka agreements as a restriction of competition by effect.
414 Krka submits that, in order to find that such a restriction exists, the Commission had to establish not that those agreements were intended to restrict competition, but that competition had in fact been restricted. In its view, the Commission failed to prove that circumstance.
415 Krka alleges that the Commission’s counterfactual analysis was unrealistic. It notes that, after the EPO decision of 27 July 2006, three options were available to it, that is to say, either to market its infringing perindopril, to refrain from marketing that medicinal product, or to attempt to settle its disputes with Servier.
416 In that respect, Krka disputes the finding, in recital 1826 of the decision at issue, that, after the EPO decision of 27 July 2006, it continued its efforts to enter Servier’s core markets. It states that, from the time of that decision, it embarked on settling its disputes with Servier. The fact that it remained present on the perindopril markets in the Czech Republic, Lithuania, Hungary, Poland and Slovenia during those negotiations cannot be interpreted as meaning that it continued its efforts to enter the other markets.
417 Krka reiterates that it refrained from discontinuing its legal proceedings with Servier in relation to the 947 patent because it wished, first, to conduct its defence in the proceedings brought by Servier and, second, to strengthen its negotiating position with a view to a settlement with that undertaking.
418 Krka also disputes the Commission’s assertion, in recitals 1827 to 1830 of the decision at issue, that it was probable that, in the absence of the Krka agreements, its efforts to enter the perindopril market would have been successful. It criticises the assessment to the effect that, in that hypothetical situation, it would have continued to dispute the validity of Servier’s patents and to market its perindopril, and that it would have sold its technology relating to the active ingredient of that medicinal product to manufacturers of generic medicines.
419 Krka recalls that, after the EPO decision of 27 July 2006, it no longer believed it was possible to obtain revocation of the 947 patent.
420 After the EPO decision of 27 July 2006, any new entry of Krka’s perindopril would have exposed that undertaking to commercial risks that it was not prepared to bear. In its view, the Commission disregarded the fact that that decision had the effect of deterring Krka from entering the perindopril markets, until the 947 patent was revoked in May 2009, in respect of markets other than those covered by the Krka licence agreement.
421 Krka rejects the claim that it could have assigned its technology relating to the active ingredient of perindopril to other manufacturers of generic medicines, because, in reality, those manufacturers had no interest in that technology.
422 The Commission disputes those arguments.
2. Findings of the Court
423 It follows from the matters of law set out in paragraphs 316 to 335 of the present judgment that the arguments relating to the counterfactual scenario which have been put forward by Krka in the context of the present plea in law are based on a misinterpretation of the burden on the Commission to establish proof of the restrictive effects on competition of agreements which, like the Krka agreements, are aimed at establishing market sharing by delaying the market entry of a generic medicine.
424 As has already been held in paragraph 331 of the present judgment, it was for the Commission to prove that the counterfactual scenario used was realistic and credible. As is apparent, in essence, from paragraph 332 of the present judgment, in so far as, in the present case, the restriction of competition at issue related to the elimination of the source of potential competition exerted by Krka on Servier, the analysis of the counterfactual scenario corresponded, in essence, to the analysis of the existence of that potential competition, which was eliminated by the Krka agreements. Thus, in order to determine whether the Krka agreements, which prohibited Krka from entering the markets in France, the Netherlands and the United Kingdom, had a proven effect on potential competition, the Commission was required to ascertain whether, in the absence of those agreements, Krka would have had a real and concrete possibility of entering those markets within a period of time capable of putting competitive pressure on Servier, with the result that the threat of such an entry could be regarded as realistic and credible (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraphs 117 to 120).
425 By taking into account, in recitals 1826, 1829 and 1835 to 1846 of the decision at issue, the economic and legal context of the Krka agreements, the Commission was entitled to consider that Krka represented one of the most immediate threats for Servier, on account of the fact that it had real and concrete possibilities of entering the markets in France, the Netherlands and the United Kingdom. The fact that it is not possible to determine with certainty whether Krka would have actually entered those markets has no bearing on the fact that, although it wished to enter those markets and had the means to do so, it agreed with Servier to forego such a possibility, on terms mutually beneficial to those two undertakings.
426 In the absence of the Krka agreements, that possibility of entry by Krka, by means of its perindopril, composed of the alpha crystalline form of erbumine protected by the 947 patent, would not have been eliminated. Consequently, the Commission established that the elimination, through the implementation of those agreements, of that source of potential competition had the effect of appreciably restricting competition. Such an elimination of potential competition was therefore an effect that was neither hypothetical nor potential, but real, and such as to justify the characterisation in recital 1850 of the decision at issue as a restriction of competition by effect.
427 The remainder of Krka’s arguments are based either on the premiss that Krka no longer exerted potential competition on Servier following the EPO decision of 27 July 2006, or on the premiss that the Krka agreements did not constitute a market-sharing agreement. Since both those premisses are incorrect, as can be seen from paragraphs 390 to 411 of the present judgment, Krka’s arguments must, therefore, be rejected.
428 The fifth plea in law of Krka’s action at first instance must, therefore, be rejected.
C. The sixth plea in law at first instance, relating to Article 101(3) TFEU
1. Arguments of the parties
429 In the alternative, Krka submits that the Commission erred in assessing the arguments seeking to establish that the Krka settlement agreement satisfied the four cumulative conditions required by Article 101(3) TFEU in order to be exempt from the prohibition provided for in Article 101(1) TFEU. That agreement, according to Krka, contributed to improving the distribution of goods, enabling consumers to receive a fair share of the resulting benefits, any restrictions were necessary in order to achieve those benefits and no competitor was eliminated from a substantial part of the relevant market.
430 First of all, Krka asserts that it is evident that the Krka settlement agreement brought about benefits for consumers. The Krka licence agreement made it possible to market Krka’s perindopril in the seven national markets covered by that agreement, thereby giving patients a choice widened to include a cheaper medicine and enabling the health insurance systems to reduce the cost of reimbursing perindopril.
431 Next, Krka states that, in the light of the EPO decision of 27 July 2006, it could no longer market its perindopril as a result of the validity of the 947 patent. It was only once it had succeeded in settling its disputes with Servier in relation to the validity of that patent that Krka was able to enter into negotiations relating to the grant of a licence for the patent in question. It notes, first, that it had only weak negotiating powers and, second, that the Krka settlement agreement did not prevent it from competing with Servier by marketing a non-infringing version of perindopril. Krka notes that, on the markets covered by the Krka licence agreement, it offered consumers a second perindopril, thus widening patient choice and enabling the health insurance systems to make savings.
432 Lastly, Krka submits that the Krka settlement agreement did not eliminate but intensified competition on the perindopril market. It observes in that respect that a single competitor was better than no competitor at all.
433 The Commission disputes those arguments.
2. Findings of the Court
434 The applicability of the exemption provided for in Article 101(3) TFEU is subject to satisfaction of four cumulative requirements laid down in that provision. Those requirements are, first, that the arrangement concerned must contribute to improving the production or distribution of the goods or services in question, or to promoting technical or economic progress; second, that consumers must be allowed a fair share of the resulting benefit; third, that it must not impose on the participating undertakings restrictions that are not indispensable; and, fourth, that it must not afford them the possibility of eliminating competition in respect of a substantial part of the products or services in question (judgment of 23 January 2018, F. Hoffmann-La Roche and Others, C‑179/16, EU:C:2018:25, paragraph 97).
435 In relation to the third of those requirements, according to which only restrictions on competition regarded as being ‘indispensable’ may enjoy an exemption under Article 101(3) TFEU, the Commission stated, in recital 2108 of the decision at issue, that that requirement was not satisfied since the restrictions accepted by Krka on Servier’s core markets were not indispensable to achieving the claimed efficiency gains on Krka’s core markets. It is clear from that recital that, ‘to avoid market sharing, Krka and Servier could have negotiated a less restrictive settlement for the Member States most immediately affected by [the litigation relating to the 947 patent] (notably the UK and the Netherlands) where the restrictions would only be based on the merits of the litigation and not leveraged by an inducement unrelated to the litigation. Alternatively, the settlement could grant Krka earlier entry or a licence for the entire EU territory, or limit the restrictions from the settlement agreement to the Member States covered by the [Krka] licence agreement’.
436 It is important to note that Krka does not rely on any argument seeking specifically to question the validity of those findings by the Commission.
437 Moreover, the conclusion of a market-sharing agreement such as that resulting from the Krka agreements cannot be regarded as being indispensable to achieving the efficiency gains claimed by Krka, having regard to the harmfulness to competition of that type of agreement, recognised in the case-law of the Court of Justice referred to in paragraphs 64 and 65 of the present judgment, and to the seriousness of the infringement committed, as is apparent from the circumstances and the considerations set out in paragraphs 392 to 412 of the present judgment.
438 In the light of those factors, the restrictions of competition resulting from the Krka agreements cannot be regarded as being ‘indispensable’ within the meaning of the third requirement for enjoying an exemption under Article 101(3) TFEU (see, by analogy, judgment of 23 January 2018, F. Hoffmann-La Roche and Others, C‑179/16, EU:C:2018:25, paragraph 98).
439 The sixth plea in law of the action at first instance must therefore be rejected.
440 Although, by the present judgment, the Court of Justice has given final judgment on certain pleas at first instance, under Article 61 of the Statute of the Court of Justice of the European Union, the state of the proceedings does not permit final judgment to be given on the matter in its entirety, with the result that Case T‑684/14 must be referred back to the General Court for it to examine the pleas in law on which a final ruling has not yet been given.
441 Since, in accordance with the form of order sought by the Commission, the Court of Justice has definitively rejected the first to third, fifth and sixth pleas in law of Krka’s action at first instance, there will no longer be any need for the General Court to examine them.
442 However, by its fourth plea, Krka disputes the characterisation of the Krka assignment and licence agreement as a restriction of competition by object within the meaning of Article 101(1) TFEU. It will fall to the General Court to examine that plea on the basis of referral.
443 In the light of the foregoing considerations, the case must be referred back to the General Court for it to rule on the fourth plea of Krka’s action at first instance, relating to the characterisation of the Krka assignment and licence agreement as a restriction of competition by object within the meaning of Article 101(1) TFEU.
Costs
444 Since the case has been referred back to the General Court, the costs relating to the present appeal proceedings must be reserved.
On those grounds, the Court (First Chamber) hereby:
1. Sets aside the judgment of the General Court of the European Union of 12 December 2018, Krka v Commission (T‑684/14, EU:T:2018:918);
2. Refers the case back to the General Court of the European Union for it to rule on the fourth plea in law at first instance, relating to the characterisation of the assignment and licence agreement concluded on 5 January 2007 between Les Laboratoires Servier SAS and KRKA, tovarna zdravil, d.d. as a restriction of competition by object within the meaning of Article 101(1) TFEU;
3. Reserves the costs.
|
Arabadjiev |
Lenaerts |
Xuereb |
|
Kumin |
Ziemele |
Delivered in open court in Luxembourg on 27 June 2024.
|
A. Calot Escobar |
A. Arabadjiev |
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Registrar |
President of the Chamber |
* Language of the case: English.