1 By their appeal, Servier SAS, Servier Laboratories Ltd and Les Laboratoires Servier SAS seek to have set aside in part the judgment of the General Court of the European Union of 12 December 2018, Servier and Others v Commission (T‑691/14, ‘the judgment under appeal’, EU:T:2018:922), by which the General Court dismissed in part their action for annulment 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’), in so far as that decision concerns them, and, in the alternative, for reduction of the fine imposed on them by that decision. I. Legal context A. Regulation (EC) No 1/2003
2 Article 2 of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles [101] and [102 TFEU] (OJ 2003 L 1, p. 1), entitled ‘Burden of proof’, provides: ‘In any national or Community proceedings for the application of Articles [101] and [102 TFEU], the burden of proving an infringement of Article [101](1) or of Article [102 TFEU] shall rest on the party or the authority alleging the infringement. The undertaking or association of undertakings claiming the benefit of Article [101](3) [TFEU] shall bear the burden of proving that the conditions of that paragraph are fulfilled.’ B. The 2004 Guidelines on technology transfer agreements
3 Paragraph 209 of the European Commission Guidelines of 27 April 2004 on the application of Article [101 TFEU] to technology transfer agreements (OJ 2004 C 101, p. 2; ‘the 2004 Guidelines on technology transfer agreements’) provides: ‘In the context of a settlement and non-assertion agreement, non-challenge clauses are generally considered to fall outside Article [101(1) TFEU]. It is inherent in such agreements that the parties agree not to challenge ex post the intellectual property rights covered by the agreement. Indeed, the very purpose of the agreement is to settle existing disputes and/or to avoid future disputes.’ C. The Guidelines on the application of Article 101 [TFEU] to technology transfer agreements
4 Points 242 and 243 of the Guidelines on the application of Article 101 [TFEU] to technology transfer agreements (OJ 2014 C 89, p. 3) provide: ‘Non-challenge clauses in settlement agreements 242. In the context of a settlement agreement, non-challenge clauses are generally considered to fall outside Article 101(1) [TFEU]. It is inherent in such agreements that the parties agree not to challenge ex post the intellectual property rights which were the centre of the dispute. Indeed, the very purpose of the agreement is to settle existing disputes and/or to avoid future disputes. 243. However, non-challenge clauses in settlement agreements can under specific circumstances be anticompetitive and may be caught by Article 101(1) [TFEU]. The restriction of the freedom to challenge an intellectual property right is not part of the specific subject matter of an intellectual property right and may restrict competition. For instance, a non-challenge clause may infringe Article 101(1) where an intellectual property right was granted following the provision of incorrect or misleading information … Scrutiny of such clauses may also be necessary if the licensor, besides licensing the technology rights, induces, financially or otherwise, the licensee to agree not to challenge the validity of the technology rights or if the technology rights are a necessary input for the licensee’s production …’ II. Background to the dispute
5 The background to the dispute, as described, inter alia, in paragraphs 1 to 73 of the judgment under appeal, may be summarised as follows. A. Perindopril
6 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.
7 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 active ingredient of perindopril takes the form of a salt. The salt used initially was erbumine.
8 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 that patent was prolonged until 22 March 2005 and, in Italy, until 13 February 2009.
9 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, namely: patents EP0308339 (‘the 339 patent’), EP0308340 (‘the 340 patent’), EP0308341 (‘the 341 patent’) and EP0309324.
10 On 6 July 2001, Servier filed with the EPO patent EP1296947 (‘the 947 patent’), 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.
11 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. Disputes relating to perindopril
12 Between 2003 and 2009, a number of disputes arose between Servier and manufacturers preparing to market a generic version of perindopril. 1. The EPO decisions
13 In 2004, 10 manufacturers of generic medicines, including Niche Generics Ltd (‘Niche’), KRKA, tovarna zdravil, d.d. (‘Krka’), Lupin Ltd and Norton Healthcare Ltd, a subsidiary of Ivax Europe, which subsequently merged with Teva Pharmaceutical Industries Ltd, the parent company of the Teva group, which is specialised in the manufacture of generic medicines, filed opposition proceedings against the 947 patent before the EPO, seeking the revocation of that patent on grounds of lack of novelty, lack of inventive step and insufficient disclosure of the invention.
14 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 contested 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 from the proceedings before the EPO Technical Board of Appeal on 11 January and 5 February 2007, respectively.
15 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
16 The validity of the 947 patent has been challenged before certain national courts by manufacturers of generic medicines, and Servier has brought infringement actions and applications 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 Laboratories Ltd (‘Matrix’), Teva, Krka and Lupin.
17 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.
18 In the Netherlands, on 13 November 2007, Katwijk Farma BV, a subsidiary of Apotex, brought an action before a court of that Member State for invalidation of the 947 patent. Servier made an application to that court for an interim injunction, which was rejected on 30 January 2008. That court, by a decision of 11 June 2008 in proceedings brought on 15 August 2007 by Pharmachemie BV, a company in the Teva group, invalidated the 947 patent in respect of the Netherlands. Following that decision, Servier and Katwijk Farma withdrew their claims. C. The settlement agreements regarding the disputes relating to perindopril 1. The Niche and Matrix agreements
19 Niche is a subsidiary of Unichem Laboratories Ltd (‘Unichem’), a company governed by Indian law, which is specialised in the manufacture of generic medicines. On 26 March 2001, the companies which Niche and Matrix succeeded in law concluded a cooperation agreement for the development of a generic version of perindopril. Under that agreement, the company which Matrix succeeded in law was responsible for the production of the active ingredient of that medicinal product, while the other company which was a party to that agreement was responsible for obtaining marketing authorisations and for distributing that medicinal product.
20 On 25 June 2004, Servier brought an action for infringement of the 339, 340 and 341 patents before the High Court of Justice (England & Wales), Chancery Division (patents court), against Niche which, by way of counterclaim, sought a declaration of invalidity of the 947 patent. Matrix participated in those proceedings by giving evidence. The date of the hearing in those proceedings had been set for 7 and 8 February 2005.
21 On 8 February 2005, Servier concluded two settlement agreements in respect of those disputes and of the proceedings before the EPO relating to the 947 patent, the first with Niche and Unichem (‘the Niche agreement’) and the second with Matrix (‘the Matrix agreement’).
22 Each of those agreements contained, first, ‘non-marketing’ clauses, by which those undertakings undertook, until the expiry of Servier’s relevant patents relating to perindopril, to refrain from making, supplying or marketing any generic form of perindopril manufactured using the processes protected by those patents and, second, ‘non-challenge’ clauses, by which those undertakings undertook to abstain from and withdraw from any action seeking to challenge the validity of those patents or to obtain declarations of non-infringement.
23 In return, Servier undertook, first, not to bring any infringement actions against those undertakings and, second, to compensate them for the costs that could result from the cessation of their programme to develop a version of perindopril manufactured using the processes protected by Servier’s patents. That compensation was to give rise to two payments, the first to Niche, and the second to Matrix, each in the sum of 11.8 million pounds sterling (GBP). Those agreements covered, inter alia, all the Member States of the European Economic Area (EEA) in which the 339, 340, 341 and 947 patents were in force.
24 Under a third agreement, also concluded on 8 February 2005, Niche undertook to transfer to Biogaran marketing authorisation dossiers concerning three medicinal products other than perindopril and a marketing authorisation obtained in France for one of those three medicinal products (‘the Biogaran agreement’). In return, Biogaran was to pay Niche the sum of GBP 2.5 million, which was non-refundable even if those marketing authorisations were not obtained. 2. The Teva agreement
25 On 9 August 2005, Ivax brought an action before the High Court of Justice (England & Wales), Chancery Division (patents court), seeking a declaration of invalidity of the 947 patent. Those proceedings were suspended pending the adoption of the decision terminating the proceedings before the EPO relating to the revocation of that patent.
26 On 13 June 2006, Servier and Teva UK Limited concluded a settlement agreement (‘the Teva agreement’). That agreement, which covered only the United Kingdom, had a duration of three years, renewable for an additional period of two years. Under that agreement, Teva undertook to purchase exclusively from Servier perindopril intended for distribution in the United Kingdom. In addition to that exclusive supply clause, that agreement also contained a non-challenge clause in respect of the 339, 340, 341 and 947 patents, of which Servier was the holder, and a non-marketing clause, the scope of which was the territory of the United Kingdom. Under that non-marketing clause, Teva was required to refrain from producing or marketing in that former Member State any generic form of perindopril which Servier regarded as an infringement of its patents. In return, Servier paid Teva the sum of GBP 5 million.
27 The Teva agreement also contained a liquidated damages clause. According to that clause, if Servier were to fail to supply perindopril to Teva as of 1 August 2006, it would then be required to pay liquidated damages in the amount of GBP 500 000 per month to Teva, the latter thus having no right of remedy against Servier and no right to terminate the Teva agreement.
28 Since it had not supplied Teva with perindopril as at 1 August 2006, Servier paid Teva liquidated damages in the amount of GBP 5.5 million, in accordance with the Teva agreement, thereby bringing the total amount of the payments made under the Teva agreement to GBP 10.5 million.
29 On 23 February 2007, Servier and Teva concluded an amendment to the Teva agreement. While confirming the exclusive supply clause, that amendment provided that Teva could begin to distribute Servier’s perindopril either on a date set by Servier, on the date of revocation or expiry of the 947 patent, or on the date from which Apotex commenced distribution of a generic version of perindopril in the United Kingdom. 3. The Krka agreements
30 On 3 October 2006, in the context of actions for infringement of the 340 and 947 patents, the High Court of Justice (England & Wales), Chancery Division (patents court), issued an interim injunction against Krka and denied the motion for summary judgment by which Krka challenged, by way of counterclaim, the validity of the 947 patent.
31 Following that decision and the EPO decision of 27 July 2006, Servier and Krka concluded three agreements (‘the Krka agreements’). On 27 October 2006, they concluded a settlement agreement regarding the disputes relating to the 340 and 947 patents and a licence agreement and, on 5 January 2007, they concluded an assignment and licence agreement.
32 Under that settlement agreement, Servier withdrew its actions for infringement of those patents against Krka, and Krka waived its right to challenge the validity of those patents worldwide and to market a generic version of perindopril that would infringe the 947 patent.
33 Pursuant to the licence agreement, Servier granted Krka an exclusive, irrevocable licence on the 947 patent in the Czech Republic, Latvia, Lithuania, Hungary, Poland, Slovenia and Slovakia. In return, Krka was required to pay Servier 3% royalties on its net sales throughout those territories.
34 Pursuant to the assignment and licence agreement, Krka assigned two patent applications to Servier relating to perindopril. In return for that assignment, Servier paid Krka the sum of EUR 30 million. 4. The Lupin agreement
35 On 18 October 2006, Lupin brought an action before the High Court of Justice (England & Wales), Chancery Division (patents court), for a declaration of invalidity of the 947 patent and a declaration that the generic version of perindopril which it intended to market in the United Kingdom did not infringe that patent.
36 On 30 January 2007, Servier and Lupin brought an end to that dispute and to the proceedings between them before the EPO relating to the 947 patent, by means of a settlement agreement (‘the Lupin agreement’).
37 That agreement contained a ‘non-challenge’ clause whereby Lupin undertook not to challenge Servier’s patents relating to perindopril. It also contained a ‘non-marketing’ clause. Under the latter clause, Lupin undertook to refrain from selling a generic version of ‘perindopril erbumine … and any salt thereof’. It is apparent from paragraph 54 of the judgment under appeal that ‘Lupin was, however, authorised to market products supplied by Servier or its own perindopril in countries where a generic version of perindopril authorised by Servier was on the market or in the event that all Servier’s relevant patents had expired or in countries in which a third party had placed a generic version of perindopril on the market and in which Servier had not brought any application for injunction seeking the prohibition of its sale’. Those non-challenge and non-marketing clauses applied to the territories of all EEA Member States.
38 In addition, the Lupin agreement contained an assignment and licence clause under which Lupin assigned to Servier intellectual property rights covered by three patent applications relating to processes for the preparation of perindopril, rights which Servier undertook to license back to Lupin. In return for that assignment, Servier paid Lupin EUR 40 million.
39 Lastly, the Lupin agreement provided that Servier and Lupin would use ‘all reasonable means’ to conclude a supply agreement under which Servier would supply perindopril to Lupin. III. The decision at issue
40 On 9 July 2014, the Commission adopted the decision at issue. The Commission considered, first, that the Niche, Matrix, Teva, Krka and Lupin agreements constituted restrictions of competition by object and by effect. Consequently, it characterised those agreements as infringements of Article 101 TFEU. The Commission took the view, second, that the conclusion of those agreements, in conjunction with other actions such as the acquisition of technologies relating to the active ingredient of perindopril, constituted a strategy on Servier’s part intended to delay the entry of generic versions of that medicinal product onto the market, in which Servier held a dominant position. The Commission considered that that abuse of a dominant position constituted an infringement of Article 102 TFEU.
41 In Articles 1 to 5 of that decision, the Commission found that Servier had infringed Article 101 TFEU by participating in the Niche, Matrix, Teva, Krka and Lupin agreements. In particular, in Articles 1 and 2 of that decision, the Commission stated that the Niche agreement and the Matrix agreement had each constituted an infringement covering all the States that were members of the European Union on the date of adoption of that decision, except for Italy and Croatia, that the start date of those infringements had been 8 February 2005, except as regards Latvia, where they had started on 1 July 2005, Bulgaria and Romania, where they had started on 1 January 2007, and Malta, where they had started on 1 March 2007, and that the end date of those infringements had been 15 September 2008, except as regards the United Kingdom, where they had ended on 6 July 2007, and the Netherlands, where they had ended on 12 December 2007.
42 In Article 3 of the decision at issue, the Commission found that the Teva agreement constituted an infringement covering the United Kingdom, which had started on 13 June 2006 and ended on 6 July 2007.
43 In Article 5 of the decision at issue, the Commission found that the Lupin agreement constituted an infringement covering all the States that were then members of the European Union, except Croatia. The Commission stated that the start date of that infringement had been 30 January 2007, except as regards Malta, where it had started on 1 March 2007, and Italy, where it had started on 13 February 2009, and that the end date of that infringement had been 6 May 2009, except as regards the United Kingdom, where it had ended on 6 July 2007, the Netherlands, where it had ended on 12 December 2007, and France, where it had ended on 16 September 2008.
44 In Article 7(1) to (5) of the decision at issue, the Commission set the total amount of the fines imposed on Servier for the infringements of Article 101 TFEU at EUR 289 727 200, including EUR 131 532 600 for its participation in the Niche agreement, EUR 79 121 700 for its participation in the Matrix agreement, EUR 4 309 000 for its participation in the Teva agreement, EUR 37 661 800 for its participation in the Krka agreements and EUR 37 102 100 for its participation in the Lupin agreement. IV. The procedure before the General Court and the judgment under appeal
45 By document lodged at the Registry of the General Court on 21 September 2014, Servier brought an action seeking, principally, the annulment of the decision at issue and, in the alternative, a reduction in the amount of the fine imposed on it by that decision.
46 By document lodged on 2 February 2015, the European Federation of Pharmaceutical Industries and Associations (EFPIA) sought leave to intervene in support of the form of order sought by Servier. That request was granted by an order of the President of the Second Chamber of the General Court of 14 October 2015.
47 In its action at first instance, Servier raised 17 pleas in law in support of its claim for annulment of the decision at issue.
48 As regards the infringements of Article 101 TFEU, the General Court upheld the pleas directed against the finding of an infringement resulting from the Krka agreements. It rejected those relating to the unlawful nature of the Niche, Matrix, Teva and Lupin agreements (‘the agreements at issue’). It rejected Servier’s alternative claims seeking cancellation or reduction of the fines imposed on it on account of its participation in the Niche, Teva and Lupin agreements. By contrast, the General Court reduced the amount of the fine imposed on Servier on account of its participation in the Matrix agreement to EUR 55 385 190. V. The procedure before the Court of Justice and the forms of order sought
49 By document lodged at the Registry of the Court of Justice on 28 February 2019, Servier brought the present appeal.
50 By document lodged at the Registry of the Court on 22 May 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 16 June 2019, the President of the Court of Justice granted that application.
51 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). Servier, the Commission and the United Kingdom complied with that request within the prescribed period.
52 By its appeal, Servier claims that the Court should: - principally, set aside points 4 to 6 of the operative part of the judgment under appeal; - annul Article 1(b), Article 2(b), Article 3(b), Article 5(b) and, consequently, Article 7(1)(b), Article 7(2)(b), Article 7(3)(b) and Article 7(5)(b) of the decision at issue or, in the alternative, refer the case back to the General Court for a ruling on the effects of the agreements at issue; - in the alternative, set aside points 4 and 5 of the operative part of the judgment under appeal in so far as they confirm the findings made in the decision at issue concerning the existence of separate infringements and cumulative fines in respect of the Niche and Matrix agreements and, consequently, annul Article 1(b), Article 2(b), Article 7(1)(b) and Article 7(2)(b) of that decision; - in the further alternative, set aside points 4 and 5 of the operative part of the judgment under appeal and annul Article 7(1)(b), Article 7(2)(b), Article 7(3)(b) and Article 7(5)(b) of the decision at issue in view of the ground of appeal concerning breach of the principles of legality of criminal offences and penalties and of proportionality in the determination of the amount of the fine; - set aside point 5 of the operative part of the judgment under appeal and annul Article 5(b) and Article 7(5)(b) of the decision at issue in view of the ground of appeal concerning the duration of the alleged infringement and the calculation of the amount of the fine in relation to the Lupin agreement and, consequently, set the amount of the fine in the exercise of its unlimited jurisdiction; and - order the Commission to pay the costs.
53 The Commission contends that the Court should: - dismiss the appeal; and - order the appellants to pay the costs relating to the proceedings before both the General Court and the Court of Justice.
54 EFPIA contends that the Court should: - set aside points 4 to 6 of the operative part of the judgment under appeal; - annul Article 1(b), Article 2(b), Article 3(b) and Article 5(b) of the decision at issue and, consequently, Article 7(1)(b), Article 7(2)(b), Article 7(3)(b) and Article 7(5)(b) of that decision, or, in the alternative, refer the case back to the General Court; and - order the Commission to pay the costs of the appeal and of the proceedings at first instance.
55 The United Kingdom contends that the Court should grant the form of order sought by the Commission. VI. The appeal
56 Servier relies on seven grounds in support of its appeal. The first ground of appeal alleges errors of law as regards the concept of restriction of competition by object within the meaning of Article 101(1) TFEU. The second ground of appeal alleges errors of law as regards potential competition exerted by the manufacturers of generic medicines on Servier. The third, fourth and fifth grounds of appeal concern the General Court’s findings with respect to the Niche, Matrix, Teva and Lupin agreements. In the alternative, Servier alleges, by its sixth ground of appeal, errors of law as regards the characterisation of the Niche and Matrix agreements as separate infringements. In the further alternative, Servier alleges, by its seventh ground of appeal, breach of the principle of legality of criminal offences and penalties and of the principle of proportionality, as regards the fines imposed on it under Article 101 TFEU. A. Preliminary observations on admissibility
57 In so far as the Commission disputes the admissibility of some of the grounds and arguments of the appeal, by alleging, inter alia, that Servier has not identified the grounds of the judgment under appeal to which they relate, that it has made general assertions unrelated to the objections and the reasoning set out in the decision at issue and in the judgment under appeal, that it has reiterated some of its arguments put forward at first instance without explaining how they establish errors of law committed by the General Court, and that it is challenging factual assessments made by that court, it is appropriate to recall at the outset the limits of the judicial review exercised by the Court of Justice on appeal.
58 In that regard, it should first of all be pointed out 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 exclusive jurisdiction to find and appraise the relevant facts and to assess the evidence (judgment of 10 July 2019, VG v Commission , C‑19/18 P, EU:C:2019:578, paragraph 47 and the case-law cited).
59 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).
60 Next, it should be noted that complaints based on findings of fact and on the assessment of those facts in the contested decision are admissible on appeal where it is contended 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).
61 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).
62 Lastly, it should be borne in mind that it follows from Article 256 TFEU, the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union and Article 168(1)(d) and Article 169(2) of the Rules of Procedure of the Court of Justice that an appeal must indicate precisely the contested elements of the judgment or order which the appellant seeks to have set aside and also the legal arguments specifically advanced in support of the appeal (see, to that effect, judgment of 20 September 2016, Mallis and Others v Commission and ECB , C‑105/15 P to C‑109/15 P, EU:C:2016:702, paragraphs 33 and 34). According to the settled case-law of the Court of Justice, that requirement is not satisfied by an appeal which confines itself to reproducing the pleas in law and arguments previously submitted to the General Court. Such an appeal amounts in reality to no more than a request for re-examination of the application submitted to the General Court, which the Court of Justice does not have jurisdiction to undertake (judgment of 24 March 2022, Hermann Albers v Commission , C‑656/20 P, EU:C:2022:222, paragraph 35 and the case-law cited).
63 However, provided that an appellant challenges the interpretation or application of EU law by the General Court, the points of law examined at first instance may be discussed again in the course of an appeal. Indeed, if an appellant could not thus base its appeal on pleas in law and arguments already relied on before the General Court, an appeal would be deprived of part of its purpose (judgment of 24 March 2022, Hermann Albers v Commission , C‑656/20 P, EU:C:2022:222, paragraph 36 and the case-law cited). B. The first and second grounds of appeal, relating to the criteria for assessing the concepts of restriction of competition by object and of potential competition
64 By its first and second grounds of appeal, Servier submits that the General Court erred in law in the interpretation and application of the concepts of restriction of competition by object and of potential competition. 1. Admissibility
65 The Commission contends that the first and second grounds of appeal are inadmissible in part. It criticises the general and abstract nature of part of the line of argument put forward by Servier which, it argues, did not set out with the requisite degree of precision the grounds of the judgment under appeal which it contests and the errors of law on which it relies. In addition, the Commission maintains that Servier merely repeats arguments put forward at first instance without explaining what errors of law the General Court committed in rejecting those arguments. According to the Commission, it follows that the first and second grounds of appeal are admissible only in so far as Servier’s line of argument is linked to a complaint specific to the Niche, Matrix, Teva or Lupin agreement, identifies precisely the ground of the judgment under appeal contested by it, and sets out the error of law allegedly committed by the General Court.
66 In the present case, it is true that the first and second grounds of appeal raised by Servier seek to call into question, in a general and abstract manner, the validity of the legal criteria on the basis of which the General Court ruled on whether the agreements at issue should be characterised as a restriction of competition by object. It is also true that, in the context of those grounds of appeal, the appeal does not indicate systematically and precisely the paragraphs of the judgment under appeal that are contested or the legal arguments seeking to demonstrate the existence of errors of law, and occasionally confines itself to repeating arguments put forward at first instance.
67 However, as the Commission expressly acknowledges, that line of argument, despite its general nature, overlaps with and supplements the line of argument which Servier develops specifically in relation to each of the agreements at issue, in the context of the third, fourth, fifth and sixth grounds of its appeal. The fact that Servier chose to divide its legal arguments concerning the unlawful nature of the agreements at issue into two parts, one general and relevant for the purpose of examining all those agreements, and the other specific to each of those agreements taken individually, does not render it inadmissible in the light of the principles referred to in paragraphs 58 to 63 of the present judgment. It is apparent from a combined reading of all those grounds of appeal that the appeal makes it possible to identify in a sufficiently precise manner both the paragraphs of the judgment under appeal that are contested by Servier and the legal arguments relied on in support of its criticisms.
68 Since the first and second grounds of appeal are sufficiently clear and precise to enable the Commission to defend itself and the Court to exercise its power of review, those grounds of appeal are admissible. The Court will rule on the other pleas of inadmissibility raised more specifically by the Commission in the context of the examination of the third, fourth, fifth and sixth grounds of appeal. 2. Substance (a) Preliminary observations
69 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.
70 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).
71 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 who 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).
72 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).
73 Accordingly, as regards practices characterised as restrictions of competition by object, there is no need to examine, nor a fortiori to prove, 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).
74 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).
75 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).
76 In that regard, in the economic and legal context of which the conduct in question forms a part, it is necessary to take into consideration the nature of the products or services concerned, as well as the real conditions of the structure and functioning of the sectors or markets in question. It is not, however, 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, paragraph 166).
77 As regards the objectives pursued by the conduct in question, a determination must be made of the objective aims which that conduct seeks to achieve from a competition standpoint. Nevertheless, 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).
78 The application of the principles set out above with regard to collusive practices in the form of horizontal cooperation agreements between undertakings, such as the agreements at issue, involves determining, at an initial stage, whether those practices may be classified as a restriction of competition by undertakings that 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.
79 As regards the initial 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 not present in 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).
80 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 for 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).
81 The Court of Justice 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).
82 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).
83 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 it being necessary for that net gain to be necessarily 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).
84 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 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).
85 It is in the light of the foregoing that it must be ascertained whether the General Court erred in law in ruling on Servier’s arguments, invoked in particular in the context of the fourth plea at first instance, alleging errors of law in the definition of the legal criteria applicable to the analysis of the object and effects of the agreements at issue in the light of Article 101 TFEU, and on the arguments developed more specifically as regards the application of those criteria to each of those agreements.
86 Thus, once the existence of the elements relating to potential competition, which are the subject of the general criticisms made in the context of the second ground of appeal, has been established, it is necessary, at the second stage of the abovementioned analysis, to ascertain whether the General Court did not err in law in finding that the agreements at issue restricted competition by object within the meaning of Article 101(1) TFEU. It is also necessary to ascertain whether the General Court examined, in that context, the objectives of those agreements and, more specifically, the question whether the transfers of value by Servier to the manufacturers of generic medicines were sufficiently significant to induce those manufacturers to refrain, even if only temporarily, from entering the perindopril market.
87 Furthermore, it must be ensured that the General Court took into account, if necessary, the intentions of the undertakings involved in order to ascertain whether those intentions bore out its analysis, in the light of the factors referred to in the preceding paragraph, of the objective aims which those undertakings were seeking to achieve from a competition standpoint, bearing in mind nevertheless that, according to the case-law referred to in paragraph 77 of the present judgment, 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. 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).
88 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 economic and legal 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).
89 In the present case, in a part of the judgment under appeal dealing with the errors of law allegedly committed by the Commission relating to the concept of restriction of competition by object, the General Court first of all examined in a general manner, in paragraphs 219 to 307 of that judgment, the criteria for considering that patent dispute settlement agreements fall within that concept, before setting out, in paragraphs 316 to 386 of that judgment, the criteria for assessing potential competition. In so doing, it reversed the order in which those two elements, set out in paragraph 78 of the present judgment, must in principle be examined, since it is not necessary to examine whether agreements have as their object the restriction of competition if the undertakings in question are not in competition with each other. However, that reversal in itself has no bearing on the merits of the General Court’s analysis of those two elements in the present case. Indeed, when subsequently ruling specifically on the pleas put forward at first instance concerning the unlawful nature of the agreements at issue in the light of Article 101 TFEU, the General Court followed that order, since it systematically examined the question whether there was a potential competitive relationship between the parties to those agreements before analysing whether those agreements should be characterised as a restriction of competition by object.
90 In the light of the foregoing, in so far as the second ground of appeal relates to the criteria concerning potential competition, it is appropriate to rule on that ground of appeal first, and then to examine the first ground of appeal, which relates to the criteria for characterisation as a restriction of competition by object. (b) The criteria relating to potential competition (second ground of appeal) (1) Arguments of the parties
91 By its second ground of appeal, which is divided into three parts, Servier submits that the judgment under appeal is based on a broad interpretation of the concept of potential competition and reverses the burden of proof borne by the Commission. It maintains, as a preliminary point, that the mere conclusion of a patent dispute settlement agreement does not permit the inference that there is potential competition between the parties to that agreement. Furthermore, it argues that, in paragraph 386 of the judgment under appeal, the General Court held that it was sufficient, in order to establish the existence of a potential competitive relationship, that the Commission, in the absence of evidence to the contrary concerning technical, regulatory or financial difficulties, compile a body of consistent evidence attesting to steps being taken to produce and market the product at issue within a sufficiently short period to form a constraint on the incumbent operator in the market concerned. According to Servier, that assessment led the General Court to make three errors of law.
92 By the first part of its second ground of appeal, Servier submits that the General Court disregarded the patent-related obstacles. It maintains that that court held, in paragraphs 384, 444 and 728 of the judgment under appeal, that, in the absence of any final decision of an authority with respect to the existence of acts of infringement and the validity of a patent, the parties’ assessment of the chances of success of litigation could be taken into account only by reference to the intention of the parties. According to Servier, the General Court therefore ruled out the possibility that, prior to the adoption of such a decision, the parties’ perception of the validity of a patent could be taken into consideration for the purpose of determining whether the manufacturers of generic medicines had the ability to enter the market concerned. Since, by definition, a settlement agreement relating to a dispute can be concluded only prior to the adoption of such a decision, it argues that the General Court thus required a condition which was impossible to satisfy and unsuited to the context of pharmaceutical patent disputes. In addition, Servier criticises the General Court for having rejected, in paragraphs 366, 367, 591 and 592 of the judgment under appeal, the taking into account of court injunctions in that context owing to their provisional nature.
93 According to Servier, even in the absence of such a decision, the ability of a manufacturer of generic medicines to enter the market may be called into question by the existence of a patent if it is perceived as being sufficiently strong to deter that manufacturer from entering ‘at risk’, given the possibility of being the subject of an infringement action brought by the manufacturer of the originator medicine. Servier states, in that regard, that the General Court expressly found such a deterrent effect resulting from Krka’s perception of the validity of the 947 patent. It submits that the General Court thus erred in law in such a way as to vitiate the characterisation of Niche, Matrix, Teva and Lupin as potential competitors of Servier.
94 By the second part of its second ground of appeal, Servier submits that the General Court erred in law in holding, in paragraph 386 of the judgment under appeal, that a body of evidence attesting to the existence of mere steps being taken to produce and market a generic medicine, in respect of which the chances of success within a short period of time are unknown, was sufficient to demonstrate a real and concrete ability to enter the market. According to Servier, such steps attest - at most - to a desire to enter the market, but are not sufficient to establish, where there are very high barriers to entry, the concrete likelihood of sufficiently rapid market entry, which would depend on the development stage of the generic medicine and on the ability of the manufacturer of that medicinal product to obtain a marketing authorisation. It argues that, in those circumstances, the General Court could not rule out the possibility, in paragraph 340 of that judgment, that delays in the process of market entry experienced by the manufacturers of generic medicines might adversely affect their ability to enter that market. Servier also alleges several errors relating to the assessment of potential competition as regards the agreements at issue.
95 By the third part of its second ground of appeal, Servier, supported by EFPIA, criticises the General Court for holding that, in order to call into question the evidence of the existence of potential competitive relationships relied on by the Commission, it was for the undertakings liable for the infringements established by the decision at issue to prove that the arrival of new entrants on the market met insurmountable barriers. It maintains that, in so doing, the General Court reversed the burden of proof borne by the Commission and required of those undertakings proof that was impossible to adduce ( probatio diabolica ). In order to call into question the evidence of the existence of potential competition, Servier argues that it is sufficient to show that the Commission’s claims are doubtful or erroneous.
96 Moreover, it maintains that, in paragraph 386 of the judgment under appeal, the General Court could not, without infringing the principle of sound administration, impose on Servier the burden of demonstrating that manufacturers of generic medicines were faced with insurmountable barriers since, according to Servier, only those manufacturers have relevant information in that regard. It submits that, by refusing to use its investigative powers to gather such information, the Commission infringed the principle of sound administration.
97 The Commission, supported by the United Kingdom, disputes those arguments. (2) Findings of the Court
98 As regards the criteria for establishing whether two undertakings are potential competitors of each other, the General Court held, in essence, in paragraphs 318 to 321 of the judgment under appeal, that a potential competitor is one which has real and concrete possibilities of entering the market in question. According to that court, such a finding must be based on two criteria, namely, first, the ability and, second, the intention to enter that market, it being specified that the first of those criteria is essential. It also held, in paragraphs 334 to 341 of that judgment, that an undertaking cannot be described as a potential competitor unless its potential market entry could take place sufficiently quickly to form a constraint on the undertakings present on that market and thus exert competitive pressure on them.
99 In paragraphs 342 to 348 of the judgment under appeal, the General Court observed that evidence of the existence of potential competition may be supported by the perception, on the part of the undertakings present on the market, of the competitive threat represented by the possibility of a new entrant joining that market. It noted, in that regard, referring to its own case-law, that the conclusion of an agreement between those undertakings may constitute an indication of that perception capable of supporting a finding of potential competition.
100 Where, on the basis of those criteria, it can be established that manufacturers of generic medicines have real and concrete possibilities of entering the market, such a finding cannot, according to the General Court, for the reasons set out in paragraphs 319 to 324 of the judgment under appeal, be called into question by the existence of barriers to that entry, such as patents or the obligation to obtain a marketing authorisation, unless those barriers are insurmountable.
101 In that regard, the General Court held, in essence, in paragraphs 355 to 368 and 384 of that judgment, that, in the absence of a final court decision finding an infringement, the existence of a valid patent does not prevent potential competition from taking place. According to the General Court, the exclusive right conferred by a patent does not preclude manufacturers of generic medicines from taking steps to be in a position to enter the market for the originator medicine following the expiry of that patent and, thus, exerting competitive pressure on the holder of that patent before that expiry.
102 In particular, the General Court stated, in paragraphs 359 to 361 of that judgment, that, although a patent enjoys a presumption of validity from the date of its registration, patent infringement cannot be presumed, but must be established by a court. Similarly, according to the General Court, in the absence of a finding of patent infringement, a declaration that a patent is invalid, such as that resulting from the EPO decision of 27 July 2006, does not exclude the possibility of potential competition.
103 The General Court also stated, in paragraph 358 of the judgment under appeal, that the legislation governing the grant of marketing authorisations for medicinal products does not constitute an insurmountable barrier to potential competition taking place, since that legislation allows the competent authorities to grant such an authorisation for a generic medicine even if the reference medicinal product is protected by a patent.
104 It follows from the foregoing that, contrary to what Servier submits, the General Court did not err in law and ruled in a manner consistent with what has been stated in paragraphs 79 to 82 of the present judgment in setting out the criteria for concluding that there is a potential competitive relationship between a manufacturer of originator medicines and a manufacturer of generic medicines. The criteria applied by the General Court correspond, in essence, to those applied by the Court of Justice in paragraphs 36 to 57 of the judgment of 30 January 2020, Generics (UK) and Others (C‑307/18, EU:C:2020:52).
105 As regards, in particular, the two criteria relating to the ability and the intention to enter the market in question, referred to in paragraph 318 of the judgment under appeal, it must be held that they correspond to those applied by the Court of Justice, inter alia in paragraph 44 of the judgment of 30 January 2020, Generics (UK) and Others (C‑307/18, EU:C:2020:52), relating to the firm intention and the inherent ability of a manufacturer of generic medicines 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.
106 As regards the complaint set out as a preliminary point in the context of the second ground of appeal, it is true, as Servier in essence asserts, that the existence of a potential competitive relationship between two undertakings operating at the same level of the production chain and one of which has no presence in the market cannot be inferred from the mere fact that those undertakings concluded a settlement agreement. However, the conclusion of such an agreement constitutes a strong indication that a competitive relationship existed between those undertakings (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others , C‑307/18, EU:C:2020:52, paragraph 55 and the case-law cited). Accordingly, the General Court did not err in law in relying on the very existence of the agreements at issue in support of the conclusion that Servier and the manufacturers of generic medicines in question were potential competitors.
107 As regards the first part of the second ground of appeal, Servier is not justified in claiming that the General Court erred in law in refusing to accept that the perception on the part of a manufacturer of generic medicines of the strength of a patent, the validity of which has not been definitively established by way of judicial proceedings, may be taken into consideration in order to determine whether the manufacturers of generic medicines had the ability to enter the market.
108 In the present case, the General Court did not consider, inter alia in paragraphs 384, 444 and 728 of the judgment under appeal, that the perception on the part of a manufacturer of generic medicines of the strength of a patent, the validity of which has not been definitively established by way of judicial proceedings, is entirely irrelevant for the purpose of assessing whether Servier and the manufacturers of generic medicines were potential competitors. By contrast, it found that, although that perception may be relevant for the purpose of determining whether such a manufacturer intended to enter the market in question, it has no role to play in determining that manufacturer’s ability to make such an entry.
109 In that regard, it should be recalled 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 which has in fact a firm intention and an inherent ability to enter the market, and which, 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 the originator medicine concerned (judgment of 30 January 2020, Generics (UK) and Others , C‑307/18, EU:C:2020:52, paragraph 46).
110 It must be held that the General Court’s reasoning, summarised in paragraph 108 of the present judgment, is not vitiated by any error of law in the light of that case-law and of the case-law referred to in paragraph 81 of the present judgment. It follows, inter alia, from that case-law that, although it is indisputably part of the relevant context, the existence of a patent protecting an originator medicine or one of its manufacturing processes, the validity of which has not been definitively established by way of judicial proceedings, and therefore a fortiori the perception of the strength of such a patent which a manufacturer of generic medicines may have, is not in itself decisive in the assessment of any potential competitive relationship between that manufacturer and the holder of that patent.
111 In addition, although the perception on the part of a manufacturer of generic medicines of the strength of a patent, as shown not by its own statements but by contemporaneous and reliable evidence, is one of the relevant factors among others, such as the preparatory steps taken with a view to entering the market, for assessing the intentions of that manufacturer and, therefore, any firm intention on its part to make such an entry, that perception - which is, by definition, subjective - is not relevant, in principle, for the purpose of assessing the inherent ability of such a manufacturer actually to enter the market, nor, moreover, is it relevant for assessing the objective existence of insurmountable barriers to such entry.
112 As regards Servier’s argument that the General Court dismissed the relevance of interim injunctions granted by a national court prohibiting a manufacturer of generic medicines from entering the market of a medicine containing an active ingredient that is in the public domain, the Court of Justice has already emphasised the limited importance of such injunctions for the purpose of assessing whether such a manufacturer and the patent holder are potential competitors, since it is an interim measure which in no way prejudges the merits of an infringement action (judgment of 30 January 2020, Generics (UK) and Others , C‑307/18, EU:C:2020:52, paragraph 53). Moreover, contrary to Servier’s line of argument, the General Court did not reject the taking into account of such interim injunctions in paragraphs 366, 367, 591 and 592 of the judgment under appeal, but simply held, in accordance with that case-law, that the grant of such injunctions, and a fortiori the mere risk of such a grant, could not in themselves prevent such a manufacturer from being a potential competitor.
113 Servier nevertheless submits that the grounds of the judgment under appeal relating to the importance to be attached to the perception on the part of the manufacturer of generic medicines of the strength of the patent are contradictory. It maintains, as set out in paragraph 93 of the present judgment, that the General Court accepted, in essence, that Krka’s recognition of the validity of the 947 patent had the consequence of precluding the agreements concluded with that manufacturer of generic medicines from being characterised as a restriction of competition by object, whereas that court held the contrary with regard to the agreements at issue.
114 However, it is sufficient to note that it is apparent, inter alia, from paragraph 304 of the judgment delivered today in Commission v Servier and Others (C‑176/19 P), that errors of law made by the General Court affect the entirety of the reasoning - set out in paragraphs 943 to 1032 of the judgment under appeal - relating to the characterisation of the settlement and licence agreements concluded with Krka as a restriction of competition by object. In particular, it is apparent from paragraphs 294 and 295 of the judgment delivered today in Commission v Servier and Others (C‑176/19 P), that the General Court verified the characterisation of the unlawful practice attributed to Servier and Krka as a restriction of competition by object on the basis of incorrect criteria, in the light of which it attached decisive importance to Krka’s recognition of the validity of the 947 patent, even though that factor was not, in itself, decisive.
115 Since the Commission’s appeal in Case C‑176/19 P was upheld in part, the Court of Justice set aside point 1 of the operative part of the judgment under appeal, by which the General Court had annulled Article 4 of the decision at issue finding that the Krka agreements constituted an infringement of Article 101 TFEU. 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 gave final judgment, in particular, on the first part of the ninth plea in law of Servier’s action in Case T‑691/14.
116 For the reasons set out in paragraphs 427 to 440 of its judgment delivered today in Commission v Servier and Others (C‑176/19 P), the Court of Justice rejected the line of argument by which Servier disputed the existence of potential competition exerted by Krka. In paragraph 441 of that judgment, the Court of Justice rejected a complaint by which Servier submitted that, on account, inter alia, of the EPO decision of 27 July 2006, Krka 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. The Court definitively held that that complaint was unfounded in the light, inter alia, of the case-law referred to in paragraphs 81 and 109 of the present judgment.
117 It follows from the foregoing that the contradictory reasoning relied on by Servier in the first part of the second ground of the present appeal is based on grounds of the judgment under appeal which have been definitively invalidated by the Court of Justice. In the absence of the alleged contradiction, Servier’s complaint alleging contradictory reasoning and, consequently, the first part of the second ground of appeal, must be rejected.
118 As regards the second part of the second ground of appeal, contrary to what Servier claims, the taking of administrative steps to obtain a marketing authorisation for a generic medicinal product may be taken into account in order to demonstrate that the manufacturer of that medicinal product had real and concrete possibilities of entering the market of the originator medicinal product. In accordance with the factors referred to in paragraph 80 of the present judgment, steps of that nature are relevant for the purpose of proving both the firm intention and the inherent ability of such a manufacturer to enter that market.
119 Servier also submits that the General Court erred in law in refusing to consider, in paragraph 340 of the judgment under appeal, that delays in the process of market entry experienced by a manufacturer of generic medicines might adversely affect that manufacturer’s ability to enter that market.
120 However, as is apparent, in essence, from paragraph 340 of that judgment, and as the Advocate General observed, in essence, in point 103 of her Opinion, a postponement of entry caused by such delays is not sufficient, by itself, to call into question the status of a manufacturer of generic medicines as a potential competitor, particularly if that manufacturer takes steps to resolve the difficulties which caused those delays. What is important in that regard is determining whether that manufacturer of generic medicines continues to exert competitive pressure on the manufacturer of originator medicines as a result of its firm intention and inherent ability to achieve such entry. As is apparent from paragraph 80 of the present judgment, it is necessary, in order to determine whether those conditions are satisfied, to assess whether that manufacturer of generic medicines has taken sufficient preparatory steps to enable it to enter the market within a period of time capable of putting competitive pressure on the manufacturer of originator medicines, although, as the Court has already had the opportunity to state, it is of no relevance whether the steps taken to that end will in fact be finalised in due time or will be successful (judgment of 25 March 2021, Lundbeck v Commission , C‑591/16 P, EU:C:2021:243, paragraph 84).
121 It follows that, in holding, in paragraph 340 of the judgment under appeal, that, in the decision at issue, the Commission was entitled to take the view that ‘any delays in the process of entering the market experienced by the generic companies were not sufficient by themselves to prevent those companies being regarded as potential competitors when they continued to exert such pressure due to their ability to enter’, the General Court did not err in law.
122 In the light of the foregoing, the second part of the second ground of appeal must be rejected.
123 As regards the third part of the second ground of appeal, contrary to what Servier claims, the General Court did not reverse the burden of proof in paragraph 386 of the judgment under appeal. In paragraph 386 of that judgment, the General Court merely held that, in the absence of evidence to the contrary concerning technical, regulatory, commercial or financial difficulties, the Commission could establish the ability and intention of manufacturers of generic medicines to enter the market, and thus their real and concrete possibilities of entering that market, if it had gathered a body of consistent evidence attesting, at the very least, to steps being taken to produce and market the medicinal product at issue within a sufficiently short period to constitute a constraint on the manufacturer of the originator medicinal product. According to the settled case-law of the Court of Justice, in matters of liability for an infringement of the competition rules, the factual evidence on which a party relies may be of such a kind as to require the other party to provide an explanation or justification, failing which it is permissible to conclude that the burden of proof has been discharged (judgments of 1 July 2010, Knauf Gips v Commission , C‑407/08 P, EU:C:2010:389, paragraph 80, and of 25 March 2021, Lundbeck v Commission , C‑591/16 P, EU:C:2021:243, paragraph 79).
124 In accordance with that case-law, if the Commission succeeds in establishing the existence of potential competition between two undertakings, on the basis of a body of consistent evidence, and without disregarding any evidence to the contrary of which it actually became aware in the course of the investigation conducted by it on an adversarial basis, including evidence relating to potential barriers to market entry, it is for those undertakings to refute the existence of such competition by adducing evidence to the contrary, which they may do either in the context of the administrative procedure or, for the first time, in the context of the proceedings before the General Court (see, in the latter regard, judgment of 21 January 2016, Galp Energía España and Others v Commission , C‑603/13 P, EU:C:2016:38, paragraph 72). Such a burden does not constitute either an undue reversal of the burden of proof or a probatio diabolica , since it is sufficient for the undertakings in question to adduce evidence of a positive fact, namely the existence of technical, regulatory, commercial or financial difficulties which, according to them, constitute insurmountable barriers to one of them entering the market. Once such evidence has been adduced, it is for the Commission to ascertain whether it invalidates its analysis as to the existence of potential competition.
125 If, on the other hand, it were for the Commission to establish, in the negative, that there were no such difficulties, and, therefore, that there was no insurmountable barrier whatsoever to the market entry of one of the undertakings in question, such a burden of proof would constitute a probatio diabolica for that institution. Furthermore, the General Court correctly observed, in paragraph 386 of the judgment under appeal, that evidence relating to the existence of potential competition is often data internal to the undertakings in question, which the latter are best placed to gather.
126 Similarly, it cannot be considered that the burden of proof described in paragraph 124 of the present judgment constitutes a breach of the principle of sound administration, on the ground that it would amount to requiring the manufacturer of originator medicines to produce, in its defence, evidence which is not in its possession but in the possession of the manufacturers of generic medicines. That complaint disregards the right of access to the file in competition cases, the purpose of which is to enable the addressees of the statement of objections to acquaint themselves, from the stage of the administrative procedure, with the evidence in the Commission’s file, so that they can defend themselves. That right of access to the file means that the Commission must provide the undertaking concerned with the opportunity to examine all the documents in the investigation file that might be relevant for that undertaking’s defence. Those documents comprise both inculpatory and exculpatory evidence, with the exception of business secrets of other undertakings, internal documents of the Commission and other confidential information (judgment of 14 May 2020, NKT Verwaltungs and NKT v Commission , C‑607/18 P, EU:C:2020:385, paragraphs 261 and 262 and the case-law cited). Thus, all the evidence of which the Commission is aware at the stage of the administrative procedure, including evidence adduced by the manufacturers of generic medicines and which is potentially exculpatory, must be included in the file to which the manufacturer of originator medicines in principle has access, so that that manufacturer has the opportunity to identify any insurmountable barriers in respect of those manufacturers of generic medicines, if they exist, and to rely on them during the administrative procedure or before the General Court.
127 Therefore, the third part of the second ground of appeal must be rejected, as must, accordingly, the second ground of appeal in its entirety. (c) The criteria relating to characterisation as a restriction of competition by object (first ground of appeal) (1) Arguments of the parties
128 By its first ground of appeal, Servier disputes the criteria on the basis of which the General Court held that the agreements at issue constituted restrictions of competition by object. That ground is divided into three parts.
129 By the first part of its first ground of appeal, Servier submits that, in accordance with the Opinion of Advocate General Wahl in CB v Commission (C‑67/13 P, EU:C:2014:1958, point 56), the concept of restriction of competition by object, which must be interpreted strictly, is reserved for conduct the harmful nature of which is proven and easily identifiable, in the light of experience and economics.
130 According to Servier, such experience was lacking on the date of the decision at issue. It maintains that, in the absence of previous decisions of the Commission or of the Courts of the European Union, the present case was a novel one at that time. Servier submits, in that regard, that the judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers (C‑209/07, EU:C:2008:643), is not relevant, since it does not concern a settlement agreement relating to pharmaceutical patent disputes. It argues that the request for a preliminary ruling which gave rise to the judgment of 30 January 2020, Generics (UK) and Others (C‑307/18, EU:C:2020:52), shows that the characterisation of that type of settlement agreement as a restriction of competition by object remained uncertain and debated. According to Servier, the present case also differs from the one which gave rise to the judgment of 25 March 2021, Lundbeck v Commission (C‑591/16 P, EU:C:2021:243), subsequent to the facts of the present case, in which the agreements in question were not actually intended to settle a dispute.
131 Furthermore, Servier disputes the assertion that the infringements of Article 101(1) TFEU imputed to it are easily identifiable. It maintains that the Commission, the General Court, the case-law of the courts of the United States of America and the legal literature prior to the adoption of the decision at issue accept that a settlement agreement relating to pharmaceutical patent disputes is not, in itself, anticompetitive. It argues, moreover, that the Commission took several hundred pages to set out its reasoning on that point.
132 By the second part of its first ground of appeal, Servier, supported by EFPIA, complains that the General Court failed to draw any conclusions from the rule, set out in paragraph 304 of the judgment under appeal and in point 56 of the Opinion of Advocate General Wahl in CB v Commission (C‑67/13 P, EU:C:2014:1958), according to which the concept of restriction of competition by object does not cover agreements which have ambivalent potential effects on the market or which are necessary for the pursuit of a main objective that does not restrict competition.
133 In that regard, it argues, agreements which bring a patent dispute to an end, without exceeding the scope of that patent, are legitimate and consistent with the public interest. In the present case, Servier maintains that, although 3 of the 10 opponents of the 947 patent withdrew from the proceedings before the EPO after having concluded a settlement agreement with Servier, that circumstance had no effect, since those proceedings continued. Moreover, it asserts that, among the agreements at issue, the Teva and Lupin agreements could have had the pro-competitive effect of bringing forward the date on which non-infringing generic medicines entered the market.
134 By the third part of its first ground of appeal, Servier submits that the General Court failed to take into account the economic and legal context of the agreements at issue. It maintains that the General Court merely held, in paragraph 272 of the judgment under appeal, that such a characterisation arises where an agreement (i) includes a payment or an inducement in the form of a benefit for a manufacturer of generic medicines as well as non-challenge and non-marketing clauses, and (ii) is concluded between undertakings in a situation of potential competition, that situation being defined broadly.
135 Servier asserts, as a preliminary point, that not every agreement restricting a competitor’s commercial freedom is necessarily restrictive of competition. It argues that such a characterisation is precluded where that restriction is ancillary to a legitimate agreement, in particular with respect to non-challenge clauses provided for under a patent dispute settlement agreement. Servier relies in that regard on paragraph 209 of the 2004 Guidelines on technology transfer agreements.
136 Servier submits, in the first place, that the General Court erred in law in holding, in paragraphs 269 to 271 of the judgment under appeal, that the existence of a ‘reverse payment’, that is to say, a payment from the manufacturer of originator medicines to the manufacturer of generic medicines intended to induce the latter manufacturer to reach a settlement, allows such an agreement to be characterised as a restriction of competition by object. It argues that, due to the excessively abstract nature of that assessment, the General Court disregarded the specific features and the real and concrete effects of the agreements at issue.
137 According to Servier, in the present case, the relevant background information demonstrates that the entry of manufacturers of generic medicines on the perindopril market was delayed, not because of the agreements at issue, but because of the 947 patent. It maintains that all the manufacturers of generic medicines which opposed that patent were forced to wait for the expiry of that patent before entering that market.
138 Servier submits in that regard that the General Court held that the Krka agreements did not constitute an infringement of Article 101(1) TFEU, after taking into account the effects of those agreements and the recognition by Krka of the validity of the 947 patent. That court thus confirmed that non-challenge and non-marketing clauses are not inherently harmful to competition.
139 In the second place, Servier submits that, contrary to what is stated in paragraph 267 of the judgment under appeal, a reverse payment is not, in itself, anticompetitive, but can be explained by the strength of the patent concerned. It argues that a strong patent induces manufacturers of generic medicines to settle. Servier maintains that, in accordance with the case-law resulting from the judgment of 25 February 1986, Windsurfing International v Commission (193/83, EU:C:1986:75, paragraph 26), the General Court should have taken such an objective factor into consideration. It argues that, in the present case, the strength of the 947 patent was recognised in the EPO decision of 27 July 2006 and by the High Court of Justice (England & Wales), Chancery Division (patents court), which granted interim injunctions against Apotex and Krka, facts which, moreover, the General Court took into account, in paragraph 971 of the judgment under appeal, in holding that they had constituted ‘one of the driving factors’ leading to the Krka agreements.
140 According to Servier, by stating, in paragraph 280 of the judgment under appeal, that the anticompetitive object of a settlement agreement may be presumed where that payment exceeds the costs inherent in the settlement of patent disputes, without the Commission being required to demonstrate that they correspond at least to the benefits expected by the manufacturer of generic medicines, the General Court relied on a broad interpretation of the concept of restriction of competition by object. It maintains that that broad interpretation not only departs from the principles recognised by the case-law, but also amounts to relieving the Commission of the burden of proving the infringement the existence of which it alleges.
141 The Commission, supported by the United Kingdom, disputes those arguments. (2) Findings of the Court
142 As regards the criteria for characterising a patent dispute settlement agreement as a restriction of competition by object, Servier submits, in essence, by the three parts raised in support of its first ground of appeal, which it is appropriate to examine together, that such characterisation is reserved for agreements the harmful nature of which is proven and easily identifiable. It maintains that such characterisation is inapplicable to those agreements in respect of which the potential effects on the market are ambivalent or which are necessary for the pursuit of a main objective that does not restrict competition. By failing to apply those criteria, it argues, the General Court erred in law.
143 It should be noted at the outset that, in the light of the criteria recalled in paragraphs 69 to 77 of the present judgment, on the basis of which an agreement between undertakings may be characterised as a restriction of competition by object, within the meaning of Article 101(1) TFEU, that line of argument must be rejected.
144 Servier is not justified in claiming that that characterisation must be rejected on the ground, in particular, that the Commission has no previous decision-making practice relating to such agreements. It is in no way necessary that the same type of agreement has already been censured by the Commission in order for such agreements to be considered to be restrictive of competition by object, and that remains the case even if they occur in a specific context, such as that of intellectual property rights. All that matters are the specific characteristics of such agreements, from which any particular harmfulness for competition can be inferred, where necessary as a result of a detailed analysis of those agreements, their objectives and the economic and legal context of which they form part (judgments of 25 March 2021, Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission , C‑586/16 P, EU:C:2021:241, paragraphs 85 to 87, and of 25 March 2021, Lundbeck v Commission , C‑591/16 P, EU:C:2021:243, paragraphs 130 and 131).
145 Similarly, Servier cannot criticise the General Court for not having taken into account the positive or at least ambivalent effects on competition to which the agreements at issue would, according to Servier, be likely to give rise, since, in accordance with the case-law referred to in paragraphs 76 and 77 of the present judgment, an examination of the effects of those agreements is not necessary, or even relevant, for the purpose of determining whether they may be characterised as a restriction of competition by object.
146 In addition, it must be stated that, in the present case, the General Court, in paragraphs 219 to 222 of the judgment under appeal, set out rules and principles which correspond, in essence, to those described in paragraphs 69 to 77 of the present judgment. Accordingly, those paragraphs of the judgment under appeal are not vitiated by an error of law.
147 As regards the line of argument based on the case-law of the Court of Justice relating to restrictions ancillary to legitimate agreements, it should be noted that the General Court held, in paragraphs 282 to 291 of the judgment under appeal, that the Commission had been entitled to refrain from examining whether it was necessary to apply that case-law.
148 In that regard, it must be pointed out that, if a given operation or activity is not covered by the prohibition rule laid down in Article 101(1) TFEU, owing to its neutrality, in that it does not involve any restriction of competition, an ancillary restriction of the commercial autonomy of one or more of the participants in that operation or activity is not covered by that prohibition rule either if that restriction is objectively necessary to the implementation of that operation or that activity and proportionate to the objectives of one or the other (see, to that effect, judgment of 11 September 2014, MasterCard and Others v Commission , C‑382/12 P, EU:C:2014:2201, paragraph 89 and the case-law cited).
149 Where it is not possible to dissociate such an ancillary restriction from the main operation or activity without jeopardising its existence and aims, it is necessary to examine the compatibility of that restriction with Article 101 TFEU in conjunction with the compatibility of the main operation or activity to which it is ancillary, even though, taken in isolation, such a restriction may appear on the face of it to be covered by the prohibition rule in Article 101(1) TFEU (judgment of 23 January 2018, F. Hoffmann-La Roche and Others , C‑179/16, EU:C:2018:25, paragraph 70).
150 Where it is a matter of determining whether a restriction can escape the prohibition laid down in Article 101(1) TFEU because it is ancillary to a main operation that is not anticompetitive in nature, it is necessary to inquire whether that operation would be impossible to carry out in the absence of the restriction in question. The fact that that operation is simply more difficult to implement or indeed less profitable without the restriction concerned cannot be deemed to invest that restriction with the objective necessity required in order for it to be classified as ‘ancillary’. Indeed, such an interpretation would effectively extend that concept to restrictions which are not strictly indispensable to the implementation of the main operation. Such an outcome would undermine the effectiveness of the prohibition laid down in Article 101(1) TFEU (judgment of 23 January 2018, F. Hoffmann-La Roche and Others , C‑179/16, EU:C:2018:25, paragraph 71).
151 In the present case, the General Court held, in paragraph 291 of the judgment under appeal, that the restrictions of competition resulting from the non-challenge and non-marketing clauses provided for in the agreements at issue were not based on the recognition of the validity of Servier’s patents but on a transfer of value from Servier to the manufacturer of generic medicines in question constituting an inducement, for that manufacturer, not to exert competitive pressure on Servier. Thus, it rejected the application of the case-law referred to in paragraph 148 of the present judgment on the ground that the agreements at issue constituted restrictions of competition by object which cannot be regarded as ‘[operations] which [are] in no way anticompetitive’ because of their alleged neutrality in terms of competition. In addition, it noted that non-challenge and non-marketing clauses could be a necessary ancillary only to a settlement agreement based on a recognition of the validity of the patent in question by the parties to that agreement, which was not the case here. In those circumstances, the General Court correctly held, in paragraph 291 of the judgment under appeal, that the Commission had validly been entitled to refrain from examining whether that case-law relating to ancillary restrictions applied.
152 In paragraphs 296 to 307 of the judgment under appeal, the General Court examined Servier’s complaints that, since the effects of the agreements at issue on competition were ambivalent in nature, those agreements could not be characterised as a restriction of competition by object.
153 In that context, in paragraph 304 of the judgment under appeal, the General Court held that the Commission and the Courts of the European Union cannot, when examining whether the object of an agreement is restrictive and, in particular, in assessing the economic and legal context of that agreement, completely ignore its potential effects, with the result that agreements which, having regard to their context, have ambivalent potential effects on the market cannot be regarded as being a restriction of competition by object.
154 However, that ground is contrary to the case-law referred to in paragraphs 73, 76 and 77 of the present judgment, according to which, as regards practices characterised as restrictions of competition by object, there is no need to examine, nor a fortiori, to prove their effects on competition, be they actual or potential, or negative or positive.
155 On the basis of that error of law, the General Court decided, in paragraphs 305 and 306 of the judgment under appeal, to rule on Servier’s complaints concerning the allegedly ambivalent effects of the agreements at issue in the context of the examination of the pleas specific to each of those agreements. It must be observed, however, without prejudice to the examination below of Servier’s arguments relating to each of those agreements, put forward in the context of its third, fourth and fifth grounds of appeal, that that error of law has no consequence, in principle, for the legality of the judgment under appeal, since, in any event, the General Court rejected all the arguments relating to the allegedly pro-competitive or ambivalent effects of the agreements at issue, put forward by Servier at first instance, on other grounds.
156 In that regard, Servier submits, in essence, that the General Court refused to take into consideration the fact that the object of the agreements at issue was not to undermine competition, but to bring to an end the disputes between Servier and the manufacturers of generic medicines, since those manufacturers recognised the strength of the 947 patent. It maintains that the purpose of the Lupin agreement, moreover, was the early market entry of Lupin and that the main aim of the Teva agreement was to supply Teva with perindopril. Servier states, in that context, that the General Court nevertheless took into account Krka’s recognition of the validity of that patent and considered that the agreements concluded with that undertaking did not constitute an infringement of Article 101 TFEU.
157 However, it is sufficient to recall that, while the objective aims which agreements seek to achieve from a competition standpoint are indeed relevant for the purpose of assessing their possible 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 bring to an end a dispute concerning the validity of a patent is economically 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.
158 In addition, Servier’s complaint that there is a contradiction between the assessments made by the General Court with regard to the agreements at issue and those made with regard to the Krka agreements must be rejected for the reasons set out in paragraphs 114 to 117 of the present judgment. In paragraphs 442 to 474 of the judgment delivered today in Commission v Servier and Others (C‑176/19 P), the Court of Justice, after upholding the Commission’s appeal in part, definitively rejected Servier’s line of argument seeking to challenge the characterisation of the settlement and licence agreements concluded with Krka as restrictions of competition by object. In the absence of the alleged contradiction, that complaint must be rejected.
159 As regards the importance that should be attached to reverse payments for the purpose of characterising patent dispute settlement agreements as restrictions of competition by object, the General Court, in paragraphs 256 to 273 of the judgment under appeal, stated, in essence, that the presence, in that type of agreement, of clauses restricting competition, such as non-challenge and non-marketing clauses, where it is associated with a reverse payment, may give rise to such a characterisation if that payment is not justified by consideration other than that consisting in the commitment made by the manufacturer of generic medicines to refrain from competing with the manufacturer of originator medicines which is the holder of the patent or patents concerned.
160 In paragraphs 277 to 280 of the judgment under appeal, the General Court held, in essence, that, in order to determine whether that condition is satisfied, it is necessary to examine whether that reverse payment is aimed at compensating costs inherent in the settlement that are borne by the manufacturer of generic medicines. The General Court stated that those costs include, in particular, expenses incurred in the context of the disputes which are the subject of the settlement agreement, provided that those expenses have been established by the parties to that agreement and that they are not disproportionate to the amount of the expenses that are objectively indispensable to the litigation. By contrast, according to the judgment under appeal, those costs do not include either the value of the stock of infringing medicinal products or the research and development costs incurred in developing those medicinal products. Those costs also exclude, as a general rule, sums payable as compensation under contracts concluded by the manufacturer of generic medicines with third parties, including for termination.
161 By its arguments summarised in paragraphs 139 and 140 of the present judgment, Servier disputes that reasoning, maintaining that it amounts to considering that any payment which exceeds the amount of the costs inherent in the settlement of the dispute constitutes a reverse payment, even if that amount is lower than the amount of the profits which the manufacturer of generic medicines could expect to derive from its market entry.
162 In addition, Servier submits that the General Court erred in law in holding, in paragraph 280 of the judgment under appeal, that the costs inherent in the settlement of a patent dispute do not, in principle, include the compensation which a manufacturer of generic medicines may have to pay to third parties for the harm that they may have suffered as a result of that manufacturer’s decision not to market the generic medicine which is the subject of that dispute.
163 In that regard, it should be recalled that, in accordance with the case-law, a manufacturer of generic medicines, after assessing its chances of success in the court proceedings between it and the manufacturer of the originator medicine concerned, may decide to abandon entry to the market in question and to conclude with that manufacturer an agreement in settlement of those proceedings. Such an agreement cannot be considered, in all cases, to be a restriction by object within the meaning of Article 101(1) TFEU. The fact that such an agreement involves transfers of value by the manufacturer of originator medicines in favour of a manufacturer of generic medicines does not constitute a sufficient ground for characterising it as a restriction of competition by object, since those transfers of value may prove to be justified. That may be the case where the manufacturer of generic medicines receives from the manufacturer of originator medicines sums which correspond in fact to compensation for the costs of or disruption caused by the litigation between them, or which correspond to remuneration for the actual supply of goods or services to the manufacturer of originator medicines (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others , C‑307/18, EU:C:2020:52, paragraphs 84 to 86).
164 Consequently, where a settlement agreement relating to a dispute concerning the validity of a patent between a manufacturer of generic medicines and a manufacturer of originator medicines, which is the holder of that patent, involves transfers of value by the manufacturer of originator medicines in favour of the manufacturer of generic medicines, it is necessary to ascertain, first, whether the net gain from those transfers may be fully justified, as envisaged in the preceding paragraph, 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 from the manufacturer of generic medicines to the manufacturer of the originator medicine (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others , C‑307/18, EU:C:2020:52, paragraph 92). Indeed, the settlement of such a dispute implies that the manufacturer of generic medicines recognises the validity of the patent in question, since it waives its right to challenge it. It follows that it is only where a ‘reverse’ payment, by the manufacturer of originator medicines to the manufacturer of generic medicines, is by way of the reimbursement of such costs or of remuneration for the supply of such goods or services that it can be regarded as consistent with such recognition and, therefore, as capable of being justified in terms of competition.
165 Second, if that net gain from the transfers is not fully justified by such a need, it must be ascertained whether, in the absence of such justification, those transfers can have no explanation other than the commercial interest of those manufacturers of medicines not to engage in competition on the merits. For the purposes of that analysis, it is necessary to determine whether that gain, including any justified costs, is sufficiently large actually to act as an incentive for the manufacturer of generic medicines to refrain from entering the market concerned; however, there is no requirement that the net gain should necessarily be greater than the profits which that manufacturer 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 87 to 94).
166 It follows that the General Court did not err in law when it held, in essence, in paragraphs 277 to 280 of the judgment under appeal, that the compensation by Servier of the litigation expenses incurred by a manufacturer of generic medicines in the context of the dispute between them which was settled was justified by the fact that such expenses were ‘inherent’ in that settlement, provided that they were not excessive and, therefore, disproportionate, but that other costs which were too ‘extraneous’ to that dispute and to its settlement could not be regarded as inherent to them. That approach, by taking into account the circumstances in which it is possible to justify the ‘reverse’ payment of costs in order to conclude that there has been no inducive transfer of value, corresponds, in essence, to the approach which stems from the case-law recalled in paragraphs 163 and 164 of the present judgment.
167 As regards, specifically, the reimbursement by the manufacturer of originator medicines of the compensation which the manufacturer of generic medicines might possibly have to pay to third parties, it must be pointed out, as the Advocate General observed in point 159 of her Opinion, in the part of that opinion dealing with Niche’s situation, that a payment of that nature is the direct consequence not of the intention of the manufacturers of medicinal products to settle disputes between them concerning patents, but of the decision of the manufacturer of generic medicines not to enter the market for the medicinal product concerned. It follows that the General Court did not err in law, in paragraph 280 of the judgment under appeal, in holding, in essence, that the reimbursement of such compensation may not be regarded as inherent in a settlement agreement such as the agreements at issue.
168 In the light of those factors, and contrary to the arguments put forward by Servier, the General Court also did not reverse the burden of proof in paragraph 280 of the judgment under appeal. Leaving aside the wording used in paragraph 280 of that judgment, the General Court confined itself, in essence, to considering that any costs owed to third parties by the manufacturer of generic medicines by way of compensation due to that manufacturer’s decision not to enter the market concerned must, where they have been covered by the manufacturer of originator medicines, be included in the transfers of value to the manufacturer of generic medicines, in respect of which the net gain must be analysed. In stating, in paragraph 280 of that judgment, that ‘it is therefore for the parties to the agreement in question, if they do not wish the payment of those costs to be regarded as an inducement, and indicative of a restriction of competition by object, to demonstrate that those costs are inherent in the dispute or in its settlement, and then to justify the amount’, the General Court correctly applied the rules relating to the allocation of the burden of proof referred to in paragraph 123 of the present judgment.
169 In the light of the foregoing and having regard in particular to the fact that, subject to the considerations set out in paragraph 155 of the present judgment in the context of the examination of the third, fourth and fifth grounds of appeal, the error of law vitiating paragraph 304 of the judgment under appeal has no bearing on the legality of the judgment under appeal, the first ground of appeal must be rejected. C. The third and sixth grounds of appeal, relating to the Niche and Matrix agreements 1. The third ground of appeal
170 By its third ground of appeal, Servier disputes the General Court’s assessments regarding the application of Article 101(1) TFEU to the Niche and Matrix agreements. That ground of appeal consists of two parts. (a) The first part, relating to potential competition (1) Arguments of the parties
171 By the first part of its third ground of appeal, Servier submits that, in considering that Niche and Matrix were its potential competitors, the General Court made several errors of law.
172 By its first complaint, Servier maintains that the General Court made an incorrect assessment of the obstacles to entry to the perindopril market resulting from the strength of Servier’s patents.
173 First of all, by reiterating, in essence, the arguments relied on in the context of its second ground of appeal, Servier alleges that the General Court, in paragraph 444 of the judgment under appeal, dismissed, as a matter of principle, the relevance of the perception which Niche and Matrix might have had of those patent-related obstacles in the analysis of their ability to enter the market, by holding that only a finding, by way of a judicial decision, that acts of infringement have occurred could constitute an insurmountable barrier to their market entry.
174 Next, it submits that the General Court failed to take into consideration both the fact that customers of Niche, and in particular Sandoz, had terminated their agreements with Niche due to the risk of infringement, and Matrix’s attempts to develop a non-infringing form of its generic version of perindopril. According to Servier, those factors constitute objective evidence of the existence of patent-related obstacles to the market entry of those undertakings.
175 Lastly, it argues that the General Court failed to ascertain whether Niche and Matrix had a real and concrete possibility of entering the market in the near future. According to Servier, Niche could not quickly overcome the patent-related obstacles.
176 For the sake of completeness, Servier submits that, in paragraphs 446 and 447 of the judgment under appeal, the General Court distorted the facts in stating that Niche, by approaching Servier, was seeking to ‘clear the way’ and to enter the perindopril market despite the patent-related obstacles. It claims that, in fact, Niche, which knew that its perindopril was infringing, wanted to avoid litigation with Servier.
177 By its second complaint, Servier submits that, in holding that the steps taken by Niche and Matrix were sufficient to demonstrate that those undertakings could enter the perindopril market in the near future, the General Court erred in law.
178 First, it maintains that the General Court confused the ability to enter the market with the intention to enter that market. According to Servier, the ability to enter the market depends on the existence of obstacles resulting from patents. It argues that, by contrast, steps such as those seeking to obtain a marketing authorisation are not sufficient, in themselves, to prove such an ability, as is apparent from paragraphs 458 and 476 of the judgment under appeal. In that regard, Servier refers to the arguments which it put forward in the context of the second part of the second ground of appeal, summarised in paragraph 94 of the present judgment.
179 Second, Servier submits that, in order to demonstrate that Niche and Matrix could enter the perindopril market, it was for the Commission to analyse the technical, regulatory, patent-related and financial difficulties with which those undertakings were confronted. It maintains that the evidence set out by the General Court in paragraphs 461, 462 and 480 of the judgment under appeal confirms that the Commission had examined only the steps taken by those undertakings. According to Servier, by failing to censure the lack of analysis of Niche and Matrix’s real and concrete chances of overcoming the technical and regulatory problems, the General Court failed to fulfil its obligation to exercise its power of review and erred in law.
180 By its third complaint, Servier submits that, by requiring it, in paragraphs 463, 480, 483 to 486, 489 and 498 of the judgment under appeal, to demonstrate that Niche and Matrix’s entry to the perindopril market met insurmountable barriers, the General Court reversed the burden of proof which the Commission bears under Article 2 of Regulation No 1/2003. Servier refers in that regard to the arguments which it put forward in the context of the third part of its second ground of appeal.
181 By its fourth complaint, Servier submits that the General Court failed to examine whether the barriers encountered by Niche and Matrix in entering the perindopril market, taken as a whole, precluded the conclusion that those undertakings were potential competitors of Servier. It argues that the fact that each of those barriers, taken individually, could be overcome, does not mean that Niche and Matrix could overcome all of those barriers. It maintains that, in so doing, the General Court infringed its obligation to exercise its power of review and its obligation to examine the evidence not separately, but as a whole.
182 By its fifth complaint, Servier submits that, in paragraph 481 of the judgment under appeal, the General Court misinterpreted the principle of sound administration. It maintains that, in accordance with that principle, the Commission is required to examine all the factors that are relevant for analysing a given situation and, if necessary, to request additional information in order to verify and substantiate its conclusions. It asserts that the Commission refused to grant Servier’s request, made during the administrative procedure, for the production of correspondence between Niche or its partners and the national authorities concerning applications for marketing authorisation for a generic version of perindopril. It argues that, in paragraph 481 of the judgment under appeal, the General Court rejected Servier’s complaint alleging breach of the principle of sound administration on the ground, inter alia, that the documents requested were not of ‘considerable importance’. According to Servier, the application of such a criterion, which is extraneous to the case-law of the Court of Justice, constitutes an error of law.
183 The Commission disputes those arguments. (2) Findings of the Court
184 By its first complaint, Servier alleges that the General Court failed to take sufficient account of the patent-related obstacles. However, the three main arguments put forward in support of that complaint, referred to in paragraphs 173 to 175 of the present judgment, disregard the fact that the General Court did indeed take into account those patent-related obstacles and are, to that extent, based on a misreading of the judgment under appeal. Indeed, as observed in paragraph 108 of the present judgment, the General Court did not consider, inter alia in paragraph 444 of the judgment under appeal, that the perception on the part of a manufacturer of generic medicines of the strength of a patent is entirely irrelevant for the purpose of assessing whether Servier, on the one hand, and Niche and Matrix, on the other, were potential competitors; rather, it considered that that perception may be relevant solely for the purpose of determining whether Niche and Matrix intended to enter the market and not for assessing their ability to make such an entry. As held in paragraphs 107 to 111 of the present judgment, the General Court did not err in law in that regard.
185 As regards the General Court’s alleged failure to take into account the fact that customers of Niche, and in particular Sandoz, terminated their cooperation with that undertaking in relation to the marketing of perindopril due to the risk of infringement, it should be recalled that, according to settled case-law, the obligation to state reasons does not require the General Court to provide an account which follows exhaustively and one by one all the arguments put forward by the parties to the case and that the reasoning may therefore be implicit on condition that it enables the persons concerned to know why the General Court has not upheld their arguments and provides the Court of Justice with sufficient material for it to exercise its power of review (judgment of 16 February 2017, Tudapetrol Mineralölerzeugnisse Nils Hansen v Commission , C‑94/15 P, EU:C:2017:124, paragraph 21 and the case-law cited).
186 It is true that the General Court did not expressly address those arguments put forward by Servier but, as the Commission contends and as is apparent from recital 465 of the decision at issue, which Servier does not dispute, Sandoz’s decision had been taken in January 2004, that is to say, before the decision of Niche and Matrix to amend their process for manufacturing perindopril and, therefore, before the preparatory steps taken by Niche and Matrix, described in paragraphs 433 to 440, 446 and 447 of the judgment under appeal, on which the General Court relied in order to establish the intention of those undertakings to enter the European perindopril markets. In those circumstances, since the factual matter in question is not, in any event, capable of affecting the General Court’s findings, that court did not infringe the obligation to state the reasons on which its judgments are based by not expressly addressing Servier’s arguments in that regard.
187 As regards the line of argument relating to Matrix’s attempts to develop a non-infringing form of its generic version of perindopril, it is sufficient to note that that line of argument seeks to call into question the General Court’s assessment of the facts in paragraph 447 of the judgment under appeal and that it must therefore be rejected as inadmissible.
188 As for the argument that the General Court failed to ascertain whether Niche and Matrix had a real and concrete possibility of entering the market in the near future, it should be borne in mind that that argument is based on an incorrect legal test since, in accordance with the case-law referred to in paragraph 80 of the present judgment, the preparatory steps taken by the manufacturer of generic medicines must enable it to enter the market concerned within such a period of time as would impose competitive pressure on the manufacturer of originator medicines. In any event, it is apparent from paragraphs 442 to 499 of the judgment under appeal that the General Court examined that matter thoroughly before concluding that the competitive pressure exerted by Niche and Matrix was real.
189 As regards the argument which Servier puts forward for the sake of completeness in support of its first complaint, it must be held that it is inadmissible. Under the guise of an alleged distortion, Servier, by claiming, in particular, that Niche’s initiative to ‘clear the way’ to market entry had not been taken in good faith, seeks in reality to challenge the factual assessments made by the General Court in paragraph 446 of the judgment under appeal, which does not fall within the jurisdiction of the Court of Justice in appeal proceedings, as recalled in paragraph 58 of the present judgment.
190 It follows that Servier’s first complaint, summarised in paragraph 173 of the present judgment, must be rejected.
191 By its second complaint, Servier disputes, by its first argument, the General Court’s assessment that the steps taken in order to obtain marketing authorisations may be taken into account for the purpose of demonstrating the existence of potential competition. However, that argument must be rejected for the reasons set out in paragraph 118 of the present judgment. Steps such as those seeking to obtain a marketing authorisation for a generic medicine are relevant for the purpose of proving both the ability and the intention of the manufacturer of that medicine to enter the market (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others , C‑307/18, EU:C:2020:52, paragraph 44).
192 By its second argument, Servier complains, in essence, that the General Court failed to analyse the likelihood that Niche and Matrix would succeed in overcoming the technical and regulatory difficulties with which they were confronted.
193 That argument cannot be accepted.
194 First of all, that argument is based on a premiss which is legally incorrect. Contrary to what Servier claims, unless it were to be held that there is no distinction between actual and potential competition, it is not necessary to demonstrate with certainty that the manufacturers of generic medicines would have entered the market and that that entry would have been successful, but only that those manufacturers had real and concrete possibilities in that respect (judgment of 25 March 2021, Lundbeck v Commission , C‑591/16 P, EU:C:2021:243, paragraph 63).
195 Next, it must be observed that the General Court carried out, in paragraphs 442 to 499 of the judgment under appeal, a detailed examination of the allegedly insurmountable barriers encountered by Niche and Matrix, from a patent-related, technical, regulatory and financial perspective. On the basis of that examination and following an assessment of the facts and evidence before it, the General Court rejected Servier’s claims disputing that Niche and Matrix had the ability and intention to enter the market. In the light of those factors, Servier cannot maintain that the General Court did not carry out a full analysis of all the barriers relied on in order to dispute the existence of a potential competitive relationship with Niche and Matrix.
196 Lastly, in so far as Servier disputes the factual assessments thus made by the General Court on the basis of that analysis, it is sufficient to note that such a line of argument is inadmissible in appeal proceedings.
197 By its third complaint, Servier submits that the General Court reversed the burden of proof in relation to insurmountable barriers to entering the market concerned. However, it is sufficient to recall that, for the reasons set out in paragraphs 123 to 125 of the present judgment, Servier’s line of argument alleging a reversal of the burden of proof and a probatio diabolica in that regard has been rejected. Accordingly, the third complaint must also be rejected.
198 By its fourth complaint, Servier complains that the General Court examined the barriers encountered by Niche and Matrix not as a whole, but separately.
199 Contrary to what the Commission contends, the fourth complaint is not inadmissible on account of the fact that it was not raised by Servier in its action at first instance. Since that complaint is directed against the application by the General Court of the rules governing the burden of proof and the assessment of evidence, it may be raised in the appeal proceedings.
200 As regards the substance, it should be borne in mind that, according to the case-law of the Court of Justice, evidence of an infringement in the field of competition law may be provided by the Commission, by means of a body of objective and consistent evidence, which, viewed as a whole, may, in the absence of another plausible explanation, constitute evidence of such an infringement even if one or another piece of that body of evidence is not, in itself, sufficient in this respect (judgment of 18 March 2021, Pometon v Commission , C‑440/19 P, EU:C:2021:214, paragraph 101 and the case-law cited).
201 As regards evidence of the existence of potential competition exerted by a manufacturer of generic medicines on a manufacturer of originator medicines, in accordance with the case-law referred to in the preceding paragraph of the present judgment and as held in paragraphs 123 to 125 of the present judgment, if the Commission succeeds in establishing the existence of potential competition, on the basis of a body of consistent evidence and without disregarding any barriers to market entry of which it is aware, it is for the undertakings concerned to refute the existence of such competition by adducing evidence to the contrary.
202 Where the Court still has a doubt, the benefit of that doubt must be given to the undertakings accused of the infringement, having regard to the presumption of innocence which applies to the procedures relating to infringements of competition rules that may result in the imposition of fines or periodic penalty payments (judgment of 16 February 2017, Hansen & Rosenthal and H&R Wax Company Vertrieb v Commission , C‑90/15 P, EU:C:2017:123, paragraph 18 and the case-law cited).
203 In the present case, the General Court stated, in paragraphs 432 to 440 of the judgment under appeal, that the evidence gathered by the Commission and referred to in the decision at issue supported the conclusion that Niche and Matrix were potential competitors of Servier, and, in paragraphs 441 to 499 of that judgment, it examined all the possible barriers to their market entry of which it was aware. Consequently, it held, without erring in law, that it was for Servier to adduce evidence to the contrary, relying, where necessary, on other barriers to such entry. As pointed out in paragraph 195 of the present judgment, following a full and detailed examination of Servier’s arguments, the General Court rejected the claims disputing that Niche and Matrix had the ability and intention to enter the market.
204 In the light of those factors, it must be observed, moreover, that the General Court did not err in law by examining one by one the alleged barriers to market entry by Niche and Matrix, without also ascertaining whether, notwithstanding the fact that none of those barriers was insurmountable on its own, their cumulative effect nevertheless gave rise to an insurmountable barrier. Such an examination is not, in principle, necessary, and as the Advocate General observed in point 91 of her Opinion, Servier did not explain, either before the General Court or in its appeal, what the examination of the evidence - which it alleges the General Court did not carry out in that regard - should have involved.
205 It follows from the foregoing that the fourth complaint must be rejected as unfounded.
206 By its fifth complaint, Servier complains that the General Court failed to find that the Commission infringed the principle of sound administration on account of the fact that the Commission did not order the production of correspondence between Niche or its partners and the national authorities concerning applications for marketing authorisation for a generic version of perindopril.
207 It must be held that, in accordance with what has been stated in paragraphs 80 and 120 of the present judgment with regard to the relevance of the steps taken to obtain marketing authorisations for the purpose of assessing potential competition, the General Court correctly pointed out, in paragraph 479 of the judgment under appeal, that, for the purpose of determining the existence of potential competition, the Commission could rely on the fact that the manufacturer of the generic medicine had applied for a marketing authorisation and actively participated in the procedure for the grant of such an authorisation. By contrast, it is for that manufacturer to provide evidence of the existence of problems objectively preventing that authorisation from being obtained.
208 However, as the Advocate General observed in point 103 of her Opinion, in the same way as the likely outcome of ongoing proceedings relating to the validity of a patent is not decisive for the purpose of assessing whether there is a potential competitive relationship, as is apparent from the case-law referred to in paragraph 81 of the present judgment, it is also not for the Commission to assess the chances of success or the likely outcome of a marketing authorisation procedure initiated before the national authorities by such a manufacturer at a time when that procedure is, or was, ongoing. Thus, in the absence of a final decision bringing such a procedure to an end, any problems objectively preventing the authorisation sought from being obtained cannot be established on the basis of evidence relating to doubts expressed by the competent national authorities, without prejudice to their final decision, as to the chances of the procedure leading to an authorisation.
209 Having noted, in paragraph 480 of the judgment under appeal, that Niche had filed several applications for marketing authorisations and had participated in the procedures for obtaining them, the General Court held, in paragraph 481 of that judgment, that the Commission could not be criticised for having refused to grant the request for production of all correspondence exchanged between Niche and the competent authorities with regard to those marketing authorisation procedures. In that respect, the General Court held, in essence, that, since Servier had in its possession, in the course of the administrative procedure, a table summarising the content of that correspondence, the Commission’s refusal to order the production of the documents concerned was justified, given that those documents were not of ‘considerable importance’ for Servier’s defence. In that regard, the General Court emphasised, inter alia, the fact that Niche had not produced the correspondence in question, either during the administrative procedure or before the General Court, in support of its complaints seeking to call into question its own status as a potential competitor of Servier.
210 In the present case, in the light of what has been held in paragraph 208 of the present judgment, it must be observed that the requested access to the correspondence in question was not capable of enabling Servier to provide evidence of the existence of problems objectively preventing the marketing authorisations sought by Niche and Matrix from being obtained. Thus, it must be held that the Commission was not obliged to order the production of that correspondence and that the General Court therefore did not err in law in the present case by not finding that the Commission had infringed the principle of sound administration. Accordingly, the fifth complaint must be rejected as unfounded.
211 In the light of all of the foregoing, the first part of the third ground of appeal must be rejected. (b) The second part, relating to the characterisation as a restriction of competition by object (1) Arguments of the parties
212 By the second part of the third ground of appeal, Servier criticises the General Court for upholding the characterisation of the Niche and Matrix agreements as a restriction of competition by object.
213 As a preliminary point, Servier refers to its arguments developed in the context of its first ground of appeal, as set out in paragraphs 129 to 140 of the present judgment, by which it submits that, in paragraphs 526, 552, 555, 557 and 558 of the judgment under appeal, the General Court applied legal criteria contrary to the case-law relating to the concept of restriction of competition by object.
214 By its first complaint, Servier submits that the General Court erred in holding that the payments of GBP 11.8 million made to Niche and Matrix were consideration for those undertakings’ decision not to compete with Servier. It maintains that it is clear from the wording of the Niche agreement that that sum was consideration for the costs and compensation that could be charged to Niche and Unichem as a consequence of ceasing their programme to develop a generic version of perindopril which constituted an infringement of Servier’s patents. According to Servier, the General Court erred in holding, in paragraph 537 of the judgment under appeal, that those costs and compensation were not inherent in the settlement agreement, even though that agreement exposed Niche and Matrix to a high risk of incurring liability. It argues that the General Court erred in holding, in paragraph 539 of the judgment under appeal, that the costs and compensation actually paid by Niche and Matrix were lower in amount than the GBP 11.8 million which they had each received from Servier. It submits that this relates to evidence subsequent to the date on which the Niche and Matrix agreements were concluded, at which time the risk incurred by those undertakings could not be accurately assessed.
215 By its second complaint, Servier submits, in essence, that, in confirming that the payments of GBP 11.8 million received by Niche and Matrix constituted consideration for the non-challenge and non-marketing clauses entered into by those companies, the General Court made three errors.
216 First, it argues that the General Court refused, in paragraph 541 of the judgment under appeal, to examine the inducive nature of those payments by comparing their amount with the profits that Niche and Matrix could each expect from their entry to the perindopril market. According to Servier, that comparison was not pointless, as the General Court held, but necessary. It maintains, moreover, that the Commission made such a comparison in recital 1338 of the decision at issue, the validity of which Servier challenged in its action at first instance. It argues that the General Court thus substituted its own grounds for those of the Commission.
217 Second, it submits that, by holding that Servier had not established that the sum of GBP 11.8 million was insufficient to constitute an inducement not to enter the market concerned, the General Court reversed the burden of proof and infringed the principle of the presumption of innocence.
218 Third, it maintains that, in paragraph 563 of the judgment under appeal, the General Court failed to take into account, in the context of the Niche, Matrix and Biogaran agreements, the patent-related, regulatory, technical and financial obstacles with which Niche and Matrix were confronted. It argues that that court merely examined that context as part of its analysis of potential competition, whereas, according to Servier, those obstacles constitute the real cause of the acceptance of the non-challenge and non-marketing clauses.
219 As regards, more specifically, the Biogaran agreement, Servier disputes the assertion that the sum of GBP 2.5 million paid to Niche under that agreement exceeded the value of the marketing authorisation dossiers transferred to Biogaran. Even if that were the case, Servier submits that that would not have been sufficient to establish the inducive nature of that payment in the absence of consideration of the context of that agreement. Servier states that the amount of that payment, which was regarded by the decision at issue only as an additional inducement, was too low to have induced Niche to settle.
220 The Commission disputes those arguments. (2) Findings of the Court
221 By its preliminary arguments, Servier reiterates that the General Court applied incorrect legal criteria in assessing whether there was a restriction of competition by object, referring to the arguments put forward in support of its first ground of appeal. Those preliminary arguments must be rejected for the same reasons as those set out in paragraphs 142 to 169 of the present judgment.
222 By its first complaint, Servier disputes the General Court’s assessment that its payments of the sum of GBP 11.8 million to Niche and Matrix were made in return for those manufacturers not entering the market. However, it must be stated that those arguments are based entirely on the premiss that the compensation which a manufacturer of generic medicines may have to pay to third parties for the harm that they may have suffered as a result of that manufacturer’s decision not to market the generic medicine which is the subject of that dispute is, in principle, part of the costs inherent in the settlement of a patent dispute. For the reasons set out in paragraph 167 of the present judgment, that premiss is incorrect. The first complaint must therefore be rejected.
223 By its second complaint, Servier submits, by its first argument, that the General Court should have compared the payments of the sum of GBP 11.8 million made to Niche and Matrix with the profits which those manufacturers could expect to derive from their entry to the perindopril market. However, that argument is unfounded. It is sufficient to recall that, in accordance with what has been held in paragraph 165 of the present judgment, in order to ascertain whether the transfers of value by the manufacturer of originator medicines in favour of the manufacturer of generic medicines constitute consideration for the latter manufacturer’s decision not to enter the market concerned, it is necessary to determine whether the net gain from those transfers of value is sufficiently large actually to act as an incentive to the manufacturer of generic medicines to make such a decision; however, there is no requirement that the net gain should necessarily be greater than the profits which that manufacturer 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 87 to 94).
224 By its second argument, Servier complains that the General Court reversed the burden of proof as regards the comparison referred to in the preceding paragraph of the present judgment. However, it follows from that paragraph that that argument is ineffective since that alleged reversal of the burden of proof relates to a comparison which it was not necessary to carry out.
225 By its third argument, Servier complains that the General Court failed to take into account the obstacles with which Niche and Matrix were confronted. It must be observed that, by that argument, Servier disputes the anticompetitive nature of the object pursued by the Niche, Matrix and Biogaran agreements, claiming that those undertakings wished to settle not because of the inducement resulting from a reverse payment offered by Servier, but because of the obstacles faced by their plans to enter the perindopril market. It thus relies on the intention of those undertakings and the fact that they were pursuing a legitimate, and not anticompetitive, aim.
226 In that regard, it should be recalled that, as is apparent from paragraphs 159 to 168 of the present judgment, the General Court did not commit any error of law in paragraphs 277 to 280 of the judgment under appeal such as to render unlawful its assessment of the situation of Niche and Matrix, carried out in paragraphs 527 to 547 of that judgment, as regards the inducive nature of the transfers of value made to them by Servier and its subsidiary Biogaran. As to the remainder, in so far as Servier seeks to call into question the factual assessments made by the Commission in that regard, its complaints are inadmissible.
227 As regards Servier’s arguments alleging patent-related obstacles to Niche and Matrix entering the market, it must be stated that they overlap with the arguments put forward in the context of potential competition, which the Court of Justice rejected in paragraphs 184 to 211 of the present judgment. In so far as the Court of Justice held that the General Court did not commit any error of law vitiating its assessment that those obstacles did not constitute insurmountable barriers to such entry, there is no reason to consider, in the absence of such barriers, that those obstacles are capable of calling into question the inducive nature of the transfers of value established, by constituting the real reason for the decision of Niche and Matrix not to enter the perindopril market in the European Union.
228 In so far as Servier relies on the absence of anticompetitive intent on the part of the parties to the Niche and Matrix agreements, it should be recalled that, as is apparent from paragraph 157 of the present judgment, 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). 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 bring to an end a dispute concerning the validity of a patent is economically 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. Servier’s third argument is therefore unfounded.
229 In the light of the foregoing considerations, the second part of the third ground of appeal must be rejected and, accordingly, the third ground of appeal must be rejected in its entirety. 2. The sixth ground of appeal, relating to the characterisation of the Niche and Matrix agreements as separate infringements
230 By its sixth ground of appeal, Servier contests the grounds on which the General Court refused to consider that the Niche and Matrix agreements constituted a single infringement. (a) Arguments of the parties
231 According to Servier, by confirming, in paragraph 1302 of the judgment under appeal, that the Niche and Matrix agreements constituted two separate infringements, for each of which the Commission was entitled to impose an individual fine on Niche and on Matrix, the General Court erred in law.
232 In the first place, Servier submits that continuous conduct, characterised by several acts with a common objective, constitutes a single infringement. It maintains that the Niche and Matrix agreements - signed on the same day, in the same place and by the same Servier representative - shared the same objective, as is apparent from paragraph 1296 of the judgment under appeal. According to Servier, contrary to the General Court’s finding in paragraph 1280 of that judgment, those agreements gave rise to coordination of Niche and Matrix’s conduct vis-à-vis Servier. It argues that, on account of the complementarity of those agreements, the General Court should have upheld the plea in law by which Servier claimed that those agreements constituted a single infringement.
233 In the second place, Servier submits that the General Court rejected classification as a single infringement on the basis of legally incorrect criteria. It argues in that regard that, in paragraphs 1296, 1297 and 1300 of the judgment under appeal, the General Court appears to have rejected classification as a single infringement on the ground that Niche and Matrix did not share the same intention. However, it maintains, such a subjective criterion is extraneous to the case-law of the General Court, which requires that that classification be based not on the subjective intention of the parties, but on objective factors (judgment of 3 March 2011, Siemens v Commission , T‑110/07, EU:T:2011:68, paragraph 246). According to Servier, since the General Court considered, on the basis of the evidence referred to in paragraph 1296 of the judgment under appeal, that the Niche and Matrix agreements pursued the same objective, it should have reached the conclusion that there had been a single infringement, notwithstanding certain differences of intention between those undertakings.
234 Servier also submits that, in paragraph 1298 of the judgment under appeal, the General Court referred to the fact that there was no ‘community of interest’ between Niche and Matrix. It maintains that that criterion is neither relevant nor necessary in the light of the case-law. It argues that, in any event, that assessment by the General Court is based on a distortion of the facts, in so far as those undertakings had concluded an oral profit-sharing agreement and an agreement to share liability vis-à-vis distributors, as is apparent from paragraph 1299 of the judgment under appeal.
235 In the third place, according to Servier, the General Court could not rely on the minor differences between the Niche and Matrix agreements referred to in paragraph 1298 of the judgment under appeal in order to call into question the existence of a common objective pursued by those undertakings.
236 In the fourth place, it submits that the General Court could not rely on disagreements between Niche and Matrix during the implementation of their agreements with Servier, in order to reject, in paragraph 1299 of the judgment under appeal, the existence of a single infringement. It maintains that such disagreements arose after the conclusion of those agreements.
237 In the fifth place, Servier submits that the fact that Matrix was not involved from the beginning of the negotiations between Niche and Servier or that it was unaware of the existence of the Biogaran agreement is not such as to call into question the existence of a single infringement.
238 The Commission disputes those arguments. (b) Findings of the Court
239 By its arguments, Servier submits that the General Court applied an incorrect legal test to determine whether Niche and Matrix had committed two separate infringements. It alleges distortion of the facts in its statement of the sixth ground of appeal, and disputes, in essence, the legal characterisation of the facts adopted by the General Court in the judgment under appeal.
240 It is clear from the settled case-law of the Court of Justice that an infringement of Article 101(1) TFEU can result not only from an isolated act, but also from a series of acts or from continuous conduct, even if one or more aspects of that series of acts or continuous conduct could also, in themselves and taken in isolation, constitute an infringement of that provision. Accordingly, if the various instances of conduct form part of an ‘overall plan’, because their identical object distorts competition within the internal market, the Commission is entitled to impute responsibility for those instances of conduct on the basis of participation in the infringement considered as a whole (see, to that effect, judgment of 6 December 2012, Commission v Verhuizingen Coppens , C‑441/11 P, EU:C:2012:778, paragraph 41 and the case-law cited).
241 An undertaking which has participated in such a single and continuous infringement through its own conduct, which fell within the definition of an ‘agreement’ or a ‘concerted practice’ having an anticompetitive object within the meaning of Article 101(1) TFEU and was intended to help bring about the infringement as a whole, may accordingly be held liable also in respect of the conduct of other undertakings in the context of that infringement throughout the period of its participation in the infringement (see, to that effect, judgment of 6 December 2012, Commission v Verhuizingen Coppens , C‑441/11 P, EU:C:2012:778, paragraph 42 and the case-law cited).
242 In that regard, it should be recalled that, for the purpose of characterising various instances of conduct as a single and continuous infringement, it is not necessary to ascertain whether they present a link of complementarity, in the sense that each of them is intended to deal with one or more consequences of the normal pattern of competition, and, through interaction, contribute to the attainment of the set of anticompetitive effects desired by those responsible, within the framework of a global plan having a single objective. On the other hand, the condition relating to a ‘single objective’ does require that it be ascertained whether there are any elements characterising the various instances of conduct forming part of the infringement which are capable of indicating that the instances of conduct in fact implemented by other participating undertakings do not have the same object or the same anticompetitive effect and, consequently, do not form part of an ‘overall plan’ by virtue of their identical object that distorts the normal pattern of competition within the internal market (judgment of 26 January 2017, Villeroy & Boch v Commission , C‑644/13 P, EU:C:2017:59, paragraph 50 and the case-law cited).
243 It should also be noted that, as the Advocate General observed, in essence, in points 239 and 240 of her Opinion, in order to characterise instances of conduct as separate infringements or as a single infringement, the Commission must demonstrate objectively, on the basis of the material in the case file and subject to review by the EU judicature, that the criteria established for characterising conduct in one way or the other are satisfied. As the General Court held in paragraph 1294 of the judgment under appeal, if it is shown that the Commission erred in making that legal characterisation of the facts, the infringement decision must be annulled and the amount of the fine set must be recalculated.
244 In the present case, the General Court recalled, in essence, the elements of the case-law referred to in paragraph 242 of the present judgment, stating in paragraph 1295 of the judgment under appeal that, ‘in order to find a single infringement, it is for the Commission to establish that the agreements at issue form part of an overall plan knowingly implemented by the undertakings in question with a view to achieving a single anticompetitive objective and that the Commission is required to examine in that regard all the facts capable of establishing or of casting doubt on that overall plan’. It must be held that the General Court did not err in law as regards the legal test applicable for the purpose of identifying a single infringement.
245 As regards the assessment of the facts of the case, the General Court considered, in paragraphs 1296 and 1297 of the judgment under appeal, that, although it was true that Servier had pursued one and the same objective when concluding the Niche and Matrix agreements, that fact did not establish that, for their part, Niche and Matrix had together pursued the same objective, thus attesting to a common plan, nor a fortiori that they participated in that common plan with Servier. In so doing, the General Court correctly applied the criteria set out in paragraphs 240 to 242 of the present judgment, according to which characterisation as a ‘single infringement’ requires that each of the instances of anticompetitive conduct concerned form part of the same overall plan as a result of their identical anticompetitive object.
246 In paragraphs 1298 and 1299 of the judgment under appeal, the General Court considered that the conclusion of the Niche and Matrix agreements on the same day, in the same place and by the same representative was not a circumstance sufficient to establish the existence of a common plan between Niche and Matrix. It noted that there were several differences between the provisions of those agreements and rejected evidence of the existence of an oral agreement between Niche and Matrix concerning the implementation of those agreements, and concluded on that basis that those undertakings did not have a ‘common plan’ allowing their conduct to be classified as a ‘single infringement’.
247 As regards the factual circumstances surrounding the conclusion of the Niche and Matrix agreements, the General Court considered, in paragraph 1300 of the judgment under appeal, that those circumstances demonstrated that Matrix had sought to seize an opportunity offered by Servier rather than acted in concert with Niche in the context of a common plan to terminate their project concerning perindopril. Matrix’s participation in the discussions that led to the conclusion of the Niche and Matrix agreements, of which it was informed only belatedly, was, according to the General Court, limited to the negotiation of the transfer of value from Servier to Matrix. Furthermore, the General Court noted, in paragraph 1301 of the judgment under appeal, that the Biogaran agreement had been concluded without Matrix’s knowledge.
248 Servier nevertheless argues that the General Court attached too much importance to the parties’ intention, whereas the case-law requires an objective assessment of the connection between anticompetitive conduct and an overall plan.
249 However, as the Advocate General noted in point 248 of her Opinion, in order for a single infringement to be found, it must be established that the conduct of the undertakings forms part of an overall plan by reason of its contribution to the achievement of a common economic objective (see, to that effect, judgment of 16 June 2022, Toshiba Samsung Storage Technology and Toshiba Samsung Storage Technology Korea v Commission , C‑700/19 P, EU:C:2022:484, paragraph 107 and the case-law cited). Proof of such a common objective may therefore be established, inter alia, on the basis of evidence relating to the parties’ intention, since the concept of an overall plan implies that the parties had the intention to cooperate in order to implement that plan and their intentions in respect of that cooperation are therefore relevant, provided that they are established on the basis of objective and reliable evidence, for the purpose of determining whether their conduct constitutes a single infringement.
250 In those circumstances, Servier is not justified in claiming that the General Court’s legal characterisation of the facts is based on an incorrect legal test. Nor has it established any distortion of the facts by the General Court.
251 The sixth ground of appeal must therefore be rejected. D. The fourth ground of appeal, relating to the Teva agreement
252 By its fourth ground of appeal, Servier disputes the General Court’s assessments regarding the application of Article 101(1) TFEU to the Teva agreement. That ground of appeal consists of two parts. 1. The first part, relating to potential competition (a) Arguments of the parties
253 By the first part of its fourth ground of appeal, Servier submits that the General Court’s analysis of potential competition is vitiated by several errors of law. On the basis of the arguments developed in the context of the second ground of appeal, Servier complains generally that the General Court imposed on it, in paragraphs 589, 591, 592, 600, 601 and 603 of the judgment under appeal, the burden of demonstrating that Teva’s market entry met insurmountable barriers in order to establish the absence of potential competition.
254 By its first complaint, Servier disputes the assessment, made in paragraphs 589, 591, 592 and 596 of the judgment under appeal, that its patents, as well as the perception that the parties might have had of them, and more specifically the risk of an interim injunction being granted on the basis of those patents, did not constitute insurmountable barriers to such entry.
255 By its second complaint, Servier criticises the General Court for having held, in paragraph 599 of the judgment under appeal, that delays in marketing authorisation procedures are not sufficient to preclude a manufacturer of generic medicines from having the status of a potential competitor. It maintains that the General Court did not analyse the effect of such delays, whereas Servier had established that those delays had jeopardised Teva’s project. It argues that the General Court also dismissed the importance, for manufacturers of generic medicines, of being among the first to enter the market concerned, whereas the Commission had expressly acknowledged that importance in recital 1126 of the decision at issue.
256 By its third complaint, Servier alleges several distortions.
257 First, it submits that, in paragraphs 586 and 609 to 612 of the judgment under appeal, the General Court distorted the evidence produced by Servier showing that Teva had no stock of perindopril benefiting from a marketing authorisation.
258 Second, Servier maintains that, in paragraph 594 of the judgment under appeal, the General Court distorted the application at first instance by stating that Servier had not disputed the statement by which Teva indicated that it was prepared to take on the risk of being the subject of an infringement action on account of its entry to the perindopril market.
259 By its fourth complaint, Servier complains that the General Court refused, in paragraph 610 of the judgment under appeal, to take account of evidence concerning defects in the generic perindopril produced on the basis of the active ingredient supplied by Hetero Drugs Ltd (‘Hetero’) on the ground that that evidence was subsequent to the conclusion of the Teva agreement. It submits that, since that evidence predates the Commission’s investigation, it has high probative value. According to Servier, in holding, in paragraph 611 of the judgment under appeal, that the email sent by Teva to Hetero on 15 October 2007 was intended ‘clearly to implement’ the Teva agreement, the General Court distorted that email.
260 The Commission disputes those arguments. (b) Findings of the Court
261 The preliminary arguments and the first complaint concerning the burden of proving the existence of insurmountable barriers to market entry are based on a misconception as to the legal criteria applicable to the assessment of potential competition, as held in paragraphs 81, 107 to 111 and 123 to 125 of the present judgment. Those arguments and that complaint must therefore be rejected for the same reasons as those set out in those paragraphs.
262 Similarly, in so far as that complaint relates more specifically to the risk of an interim injunction being granted on the basis of those patents, it should be recalled, as held in paragraph 112 of the present judgment, that the grant of such injunctions, and a fortiori the mere risk of such a grant, cannot in themselves prevent a manufacturer of generic medicines from being a potential competitor.
263 As regards the second complaint, it should be recalled that, in accordance with what has been held in paragraph 120 of the present judgment, a delay in the marketing authorisation procedures is not sufficient, by itself, to call into question status as a potential competitor. That complaint must therefore be rejected for the same reasons as those set out in paragraph 120 above. As regards the reference, in recital 1126 of the decision at issue, to the ‘first mover’ advantage enjoyed by the first manufacturer of generic medicines to launch its product, it is in no way apparent from that reference that only a manufacturer which is in a position to launch its product first may be regarded as a potential competitor of the manufacturer of originator medicines. As to the remainder, it is sufficient to note that Servier disputes the General Court’s factual assessments relating to such a delay and that its line of argument is therefore inadmissible.
264 As regards the alleged distortion of the evidence of the absence of perindopril stocks held by Teva that were covered by a marketing authorisation, it must be stated, as the Commission contends, that, since Servier did not identify precisely the evidence which it alleges to have been distorted, the Commission is not in a position to respond to that complaint and the Court of Justice cannot exercise its power of review, with the result that that complaint must be rejected as inadmissible.
265 As regards the alleged distortion of Servier’s application at first instance in paragraph 594 of the judgment under appeal, in so far as the General Court notes that Servier did not dispute, at the level of the facts, the statement made in a declaration by Teva according to which the latter was prepared to launch its perindopril despite the risk of patent infringement actions, it must be stated that the General Court responded to the substance of Servier’s arguments, in any event, by observing, in paragraph 591 of that judgment, that the risks for Teva of being the subject of patent infringement actions and interim injunctions following its entry to the perindopril market did not make it possible ‘to rule out the existence of real and concrete possibilities for Teva to overcome the obstacles associated with the patents in question’. Furthermore, it follows from paragraph 594 of the judgment under appeal that, while Teva was aware of the risks of patent infringement and of interim injunctions being granted as from February 2006, it nonetheless continued with its preparatory steps, as is apparent from paragraph 598 of that judgment.
266 In addition, as recalled in paragraph 109 of the present judgment, 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 to market entry, and does not mean that a manufacturer of generic medicines which has in fact a firm intention and an inherent ability to enter the market, and which, by the steps taken, shows a readiness to challenge the validity of that patent and to take the risk, upon entering that market, of being subject to infringement proceedings brought by the holder of that patent, cannot be characterised as a potential competitor of the manufacturer of the originator medicine concerned (judgment of 30 January 2020, Generics (UK) and Others , C‑307/18, EU:C:2020:52, paragraph 46).
267 It is therefore apparent from the factors referred to in paragraph 265 of the present judgment that, without needing to rely on the fact that Servier allegedly did not dispute Teva’s intention to enter the market at risk, the General Court examined the substance of Servier’s arguments and provided reasons to the requisite legal standard, having regard to the case-law cited in paragraph 266 of the present judgment, for its conclusion that the existence of Servier’s patents did not constitute an insurmountable barrier to Teva’s potential market entry.
268 It follows that the complaint of distortion directed against paragraph 594 of the judgment under appeal is ineffective, since it relates to a ground included in the judgment under appeal purely for the sake of completeness.
269 By its fourth complaint, Servier disputes the assessment of Hetero’s email of 15 October 2007 under the guise of alleging that it was distorted. A complaint of that nature does not, in accordance with the case-law referred to in paragraph 58 of the present judgment, fall within the jurisdiction of the Court of Justice in appeal proceedings.
270 In the light of the foregoing, the first part of the fourth ground of appeal must be rejected. 2. The second part, relating to the characterisation as a restriction of competition by object
271 By the second part of its fourth ground of appeal, Servier criticises the General Court for having, in paragraphs 698, 700 and 704 of the judgment under appeal, confirmed the characterisation of the Teva agreement as a restriction of competition by object. In that regard, Servier, while reiterating the arguments set out in the context of the first ground of appeal, submits that the fact that the Teva agreement contains clauses restricting competition and a payment inducing Teva to agree to such clauses is not sufficient to characterise that agreement as a restriction of competition by object when, inter alia, that agreement also facilitated Teva’s early market entry and therefore produced pro-competitive effects.
272 Before addressing the specific complaints raised by Servier in that context, it should be recalled at the outset that, in accordance with the case-law referred to in paragraphs 73, 76 and 77 of the present judgment, any pro-competitive effects of an agreement are irrelevant in the context of the examination of its anticompetitive object, including for the purpose of ascertaining whether it is harmful. It must also be pointed out that, as is apparent from the case-law recalled in particular in paragraph 83 of the present judgment, a delay in the market entry of generic medicines in exchange for transfers of value by the manufacturer of originator medicines in favour of the manufacturer of those generic medicines must be regarded as constituting a restriction of competition by object where 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. (a) The objectives of the Teva agreement (1) Arguments of the parties
273 Servier submits that the General Court erred in law by failing to take into consideration the aims objectively pursued by the Teva agreement, on the sole ground that that agreement contained clauses restricting competition. According to Servier, the General Court disregarded the fact that the supply of perindopril to Teva was the main objective of that agreement. It maintains that the settlement of the disputes relating to Servier’s patents was merely a ‘secondary’ objective, the scope of which was limited, since it did not extend to the proceedings pending before the EPO concerning the validity of the 947 patent. According to Servier, those objectives are not, in themselves, harmful to competition.
274 In addition, it argues that the analogy drawn by the General Court in paragraph 704 of the judgment under appeal between the Teva agreement and the circumstances of the case which gave rise to the judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers (C‑209/07, EU:C:2008:643), is unfounded, since those circumstances related not to the entry of a new competitor to the market, but to the exit of competing undertakings already present on that market.
275 The Commission disputes those arguments. (2) Findings of the Court
276 Servier disputes the existence of a restriction of competition by object, relying on the alleged legitimacy of some of the objectives set out in the Teva agreement and of the parties’ intention in that regard. According to Servier, the General Court erred in law by failing to take those objectives and that intention into account when characterising the Teva agreement as a restriction of competition by object.
277 However, it should be borne in mind that, in order to characterise conduct as a restriction of competition by object, a determination must be made of the objective aims which that conduct seeks to achieve from a competition standpoint. By contrast, as held in paragraph 87 of the present judgment, the fact that the 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. 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).
278 Moreover, in so far as Servier, in stating that the Teva agreement had as its ‘main’ objective the supply of perindopril to Teva and as its ‘secondary’ objective the settlement of disputes, seeks to rely on the case-law relating to ancillary restrictions, it must be held, for the reasons set out in paragraphs 148 to 151 of the present judgment, that that case-law is not applicable to a situation such as the one presented by the Teva agreement. First, the clause in the Teva agreement providing for the supply of perindopril to Teva is not neutral from a competition standpoint due to the existence of reverse payments constituting transfers of value and, second, in view of the existence of those payments, the restrictions of competition arising from the non-challenge and non-marketing clauses cannot be regarded as being objectively necessary for that supply clause or for the settlement of disputes, a fortiori when the non-challenge and non-marketing clauses are read in the light of the exclusive nature of the supply clause.
279 Therefore, without its being necessary to rule on the relevance of the judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers (C‑209/07, EU:C:2008:643), the complaint raised by Servier must be rejected. (b) The ambivalence of the effects of the Teva agreement (1) Arguments of the parties
280 Servier submits that, on the date on which the Teva agreement was concluded, the potential effects of that agreement, taken as a whole and in so far as they were identifiable on that date, were ambivalent, with the result that the Teva agreement cannot be characterised as a restriction of competition by object, as is apparent from its arguments put forward under the first ground of appeal. It maintains that the General Court distorted the facts relating to the context of that agreement, in particular in paragraphs 644 and 667 of the judgment under appeal, and disregarded its pro-competitive effects.
281 The Commission disputes that line of argument. (2) Findings of the Court
282 Servier cannot rely on any positive or at least ambivalent effects on competition to which the Teva agreement would be likely to give rise, since, in accordance with the case-law referred to in paragraphs 73, 76 and 77 of the present judgment, an examination of such effects, be they actual or potential, or negative or positive, is not necessary for the purpose of determining whether that agreement may be classified as a restriction of competition by object. Thus, irrespective of the fact that the alleged positive effects resulting from Teva’s early market entry were not certain to occur, since Servier had the contractual right to block such entry in return for an additional reverse payment, that line of argument cannot succeed in any event. That complaint must therefore be rejected. (c) The harmfulness of the clauses of the Teva agreement (1) Arguments of the parties
283 As regards the non-challenge clause in the Teva agreement, Servier reiterates the line of argument developed in the context of its first ground of appeal, according to which that type of normal clause is not, in itself, harmful to competition. It submits that, in paragraphs 648 and 649 of the judgment under appeal, the General Court failed to have regard to the case-law arising from the judgment of 25 February 1986, Windsurfing International v Commission (193/83, EU:C:1986:75), and erred in holding that the fact that that clause did not include the proceedings before the EPO was irrelevant.
284 As regards the non-marketing clause in the Teva agreement, it argues that, in paragraphs 663 and 664 of the judgment under appeal, the General Court disregarded the fact that the scope of that clause was limited to the perindopril infringing Servier’s patents, leaving Teva free to develop a non-infringing form of that medicinal product. It maintains that the General Court also erred in rejecting, in paragraph 666 of that judgment, evidence relating to Teva’s development of a non-infringing version of that medicinal product. According to Servier, the General Court, moreover, erred in failing to take into account the fact that the supply of generic perindopril to Teva mitigated or even eliminated any restrictive effects of that clause. It submits that the General Court acknowledged, however, in paragraph 954 of the judgment under appeal, that the restriction of competition by the settlement agreement concluded with Krka could be offset by the pro-competitive effects of the licence agreement concluded with Krka.
285 As regards the exclusive supply clause, Servier puts forward three complaints.
286 First of all, it submits that the General Court distorted that clause. It maintains that, contrary to what the General Court stated in paragraph 662 of the judgment under appeal, that clause did not prohibit Teva from obtaining supplies from other suppliers. According to Servier, Teva therefore remained free to obtain supplies from third parties producing a version of perindopril other than that composed of the alpha crystalline form of erbumine protected by the 947 patent. It argues that the General Court incorrectly inferred, in paragraph 663 of that judgment, that the Teva agreement went beyond Servier’s patents.
287 Next, Servier submits that the General Court, in paragraph 672 of the judgment under appeal, stated, incorrectly and without providing reasons, that the exclusive supply clause was untypical. It asserts that that type of clause is lawful and frequently used, inter alia by Teva.
288 Lastly, Servier submits that the exclusive supply clause should have been assessed in its context, having regard to the competition that would have occurred in the absence of that clause. It argues that, in so far as the Teva agreement enabled Teva to enter the perindopril market, characterisation as a restriction of competition by object is precluded.
289 The Commission disputes both the admissibility and the merits of those arguments. (2) Findings of the Court
290 By those arguments, Servier disputes the General Court’s assessment regarding the characterisation of the Teva agreement as a restriction of competition by object, arguing, in essence, that neither the non-challenge clause, the non-marketing clause nor the exclusive supply clause in that agreement could have caused anticompetitive effects.
291 As recalled in paragraph 88 of the present judgment, 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 economic and legal 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.
292 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. 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).
293 Thus, 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, no longer to challenge that patent and not to enter that market are liable to have effects that restrict competition, since 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 (judgment of 30 January 2020, Generics (UK) and Others , C‑307/18, EU:C:2020:52, paragraph 81).
294 As the General Court, in essence, pointed out in paragraph 305 of the judgment under appeal, it is therefore necessary, in order to determine whether an agreement may be characterised as a restriction of competition by object, not to analyse each of its clauses separately, but to assess whether that agreement, taken as a whole, reveals a degree of economic harm to the proper functioning of competition in the market concerned which justifies such characterisation. By reason of the close links between the non-challenge, non-marketing and exclusive supply clauses of the Teva agreement, it was therefore essential to examine those clauses as forming a whole.
295 In addition, Servier’s arguments do not take account of the case-law referred to in paragraph 83 of the present judgment, from which it follows that the test for determining whether a settlement agreement such as the Teva agreement constitutes a restriction of competition by object consists in ascertaining whether the transfers of value by the manufacturer of originator medicines in favour of the manufacturer of generic medicines constitute a quid pro quo for the latter manufacturer’s decision not to enter the market concerned (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others , C‑307/18, EU:C:2020:52, paragraphs 87 to 94).
296 In the present case, in paragraphs 644 and 645 of the judgment under appeal, the General Court dismissed the relevance of the potentially neutral or pro-competitive effects of the Teva agreement and rejected the applicability of the case-law relating to ancillary restrictions, without committing any errors of law capable of calling into question the conclusion that was reached in those paragraphs, as is apparent from the grounds set out in paragraphs 76 and 77, 148 to 151, 272 and 278 of the present judgment.
297 As regards the restrictions imposed on Teva concerning its conduct on the market, the General Court, in essence, confirmed the findings made in the decision at issue. For the reasons set out in paragraphs 647 to 678 of the judgment under appeal, the General Court found, first, that the non-challenge clause prohibited Teva from establishing that its perindopril did not infringe Servier’s patents and from challenging their validity in the United Kingdom. Second, it found that the non-marketing clause required Teva to refrain, in the United Kingdom, from any production or marketing of its own perindopril which Servier regarded as infringing or of any version which Servier might regard as infringing. Third, it found that the exclusive supply clause, which was closely linked to the non-marketing clause, left Teva with an alternative of either distributing Servier’s perindopril composed of the alpha crystalline form of erbumine or, in the event of failure by Servier to supply, receiving liquidated damages in the amount of GBP 500 000 per month of default. The aggregate effect of that alternative and of the combination of those clauses was, in practice, to enable Servier to prevent Teva from marketing, in the United Kingdom, without its consent, a generic version of the perindopril composed of the alpha crystalline form of erbumine.
298 Servier complains that the General Court distorted the exclusive supply clause and the non-marketing clause. It submits that, contrary to what was held in paragraphs 662 and 663 of the judgment under appeal, first, those clauses covered only the version of perindopril composed of the alpha crystalline form of erbumine, with the result that Teva remained free to purchase other forms of perindopril from third parties and to market them and, second, the scope of those clauses did not go beyond the scope of Servier’s patents.
299 In that respect, as regards paragraph 663 of the judgment under appeal, it is apparent from paragraph 6 of that judgment that the 947 patent relates specifically to the version of perindopril composed of the alpha crystalline form of erbumine and its manufacturing processes, and that judgment does not contain any other explanation casting doubt on that fact. It follows from the wording of the Teva agreement that the non-marketing and exclusive supply clauses of that agreement also applied only to the perindopril composed of the alpha crystalline form of erbumine, which therefore necessarily fell within the scope of that patent. Thus, the finding in paragraph 663 of the judgment under appeal that those clauses extended beyond the scope of Servier’s patents covered by the Teva agreement is based on a distortion of that agreement.
300 However, the General Court took into account, correctly and unequivocally, the limitation of the application of those clauses to the perindopril composed of the alpha crystalline form of erbumine in its analysis of the object of those clauses from a competitive point of view, in paragraphs 665 and 666 of the judgment under appeal. It is therefore apparent from a reading of paragraphs 662, 665 and 666 of that judgment as a whole that there was no distortion by the General Court in that regard. Furthermore, as the Advocate General noted in point 175 of her Opinion, the General Court rejected Servier’s line of argument as irrelevant on the ground that the form of perindopril which Teva was considering marketing when the Teva agreement was signed was precisely the form which was the subject of the non-marketing and exclusive supply clauses contained in that agreement. In those circumstances, the fact that the scope of those clauses was limited to that form of perindopril does not call into question their competition-restricting nature as analysed by the General Court. Thus, the distortion of those clauses found in paragraph 299 of the present judgment does not invalidate the conclusion drawn by the General Court regarding the anticompetitive nature of those clauses and relates, ultimately, to a ground included in the judgment under appeal purely for the sake of completeness. Similarly, Servier’s argument relating to the allegedly normal nature of those clauses cannot succeed, since it does not in any way call into question that anticompetitive nature.
301 As to the remainder, it is necessary to reject Servier’s other arguments relating to the alleged non-harmful nature of the non-challenge and non-marketing clauses since, as the Commission contends, those arguments seek in fact to challenge the General Court’s assessments regarding the evidence submitted to it and the factual elements relevant for the purpose of interpreting the Teva agreement. (d) The reverse payment (1) Arguments of the parties
302 As a preliminary point, Servier reiterates that the stipulation, in a patent dispute settlement agreement, of a reverse payment is not, in itself, anticompetitive. It maintains that the same applies, a fortiori, where that type of payment is provided for in the context of a supply agreement such as the Teva agreement. Servier refers in that regard to its arguments set out in the third part of the first ground of appeal, summarised in paragraphs 139 and 140 of the present judgment.
303 As regards the liquidated damages clause provided for in the Teva agreement, Servier submits that the General Court made several errors of law in paragraphs 660 and 699 of the judgment under appeal in holding that those damages formed part of the reverse payment on the basis of which that agreement had been classified as a restriction of competition by object. It argues that the General Court, in paragraph 685 of the judgment under appeal, erred in rejecting the premiss that that type of clause was normal. It maintains that even if those damages were intended to compensate Teva in return for its decision not to enter the perindopril market, that would not be sufficient to characterise it as a reverse payment. According to Servier, those liquidated damages are linked not to the patent dispute settlement, but to the non-performance of the exclusive supply obligation laid down in the Teva agreement. By definition, the payment of such damages was uncertain. It submits that, accordingly, those damages should not have been taken into account in the comparison with the costs inherent in the patent dispute settlement.
304 As regards the payment of the sum of GBP 5 million to Teva, Servier refers to its arguments put forward in the context of the first ground of appeal, in order to dispute the relevance of that payment for the purpose of characterisation as a restriction of competition by object. According to Servier, that payment was intended to cover the costs incurred by Teva as a result of the termination of its agreements with Hetero and Alembic Pharmaceuticals Ltd for the manufacture of a generic version of perindopril, the destruction of existing stocks and legal costs. It argues that those costs stem directly from the Teva agreement.
305 Servier complains that the General Court distorted its arguments relating to the cause of the payment of the sum of GBP 5 million by having stated, in paragraph 697 of the judgment under appeal, that Servier had maintained that that payment was intended to ‘secure’ the exclusive supply clause provided for in the Teva agreement, whereas Servier had argued that the purpose of that agreement was, from its point of view, to secure Teva’s services as a distributor of generic medicines in the United Kingdom. It submits that the General Court failed to verify that point.
306 The Commission disputes both the admissibility and the merits of those arguments. (2) Findings of the Court
307 The argument that Servier’s payments to Teva should not be treated as a reverse payment on the ground that the Teva agreement is not a settlement agreement but rather an exclusive supply agreement cannot be accepted. Indeed, that circumstance does not alter the fact that, as is apparent from paragraphs 290 to 300 of the present judgment, that agreement contained restrictions of competition by object and, therefore, as pointed out, inter alia, in paragraph 272 of the present judgment, the payment by Servier of sums of money in return for Teva’s acceptance of those restrictions is capable of constituting such a payment.
308 Furthermore, in order to be caught by the prohibition laid down in Article 101(1) TFEU, a collusive practice must fulfil various 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, as recalled in paragraph 292 of the present judgment. As the application of that provision is based on an assessment of the economic repercussions 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). Moreover, 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.
309 The arguments by which Servier claims that neither the initial payment of GBP 5 million nor the liquidated damages of GBP 5.5 million should be regarded as forming part of a reverse payment must also be rejected. As is apparent from paragraphs 161 to 167 of the present judgment, it is necessary to ascertain whether the net gain from such transfers may be fully justified by the need to compensate for the costs of or disruption caused by that dispute and, if that is not the case, to assess whether that net gain from those 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.
310 It is apparent from a reading of paragraphs 687 to 699 of the judgment under appeal that the General Court analysed in detail the question whether the two payments at issue were necessary, in accordance with the conditions stemming from the case-law referred to in paragraphs 161 to 167 of the present judgment, and the question whether those two payments, having regard in particular to their size, had induced Teva to accept the restrictions of competition provided for in the Teva agreement. Since Servier did not succeed in adducing evidence capable of calling into question the findings made by the Commission in the decision at issue, the General Court, on the basis of the considerations set out in paragraphs 687 to 699 of the judgment under appeal, held, without erring in law, that the sum of GBP 10.5 million which Servier paid to Teva had induced the latter to refrain from entering the market.
311 Servier’s arguments relating to the reverse payment must therefore be rejected, as must the fourth ground of appeal in its entirety. E. The fifth ground of appeal, relating to the Lupin agreement
312 By its fifth ground of appeal, Servier disputes the General Court’s assessments regarding the application of Article 101(1) TFEU to the Lupin agreement. That ground of appeal consists of three parts. 1. The first part, relating to potential competition (a) Arguments of the parties
313 By the first part of its fifth ground of appeal, Servier complains that the General Court erred in law in its application of the legal test for characterising Lupin as a potential competitor and refers, in that regard, to its arguments developed in the context of its second ground of appeal.
314 In the first place, Servier submits that the judgment under appeal is vitiated by several distortions.
315 It maintains that, as regards the facts, the General Court stated, in paragraphs 729 and 730 of the judgment under appeal, that, after the EPO decision of 27 July 2006, the evidence in the file does not mention or even suggest that Lupin had considered abandoning its challenge to the validity of the 947 patent. It submits that that statement is incorrect and that the General Court distorted the facts in this respect. Servier argues that Lupin brought an appeal against that decision and filed an application for invalidation of the 947 patent before a court in the United Kingdom which was joined to those filed by Apotex and Krka, but that it was not confident of its chances of success, contrary to what is stated in recital 1016 of the decision at issue.
316 It submits that, moreover, the General Court distorted the facts in holding, in paragraphs 748 and 749 of the judgment under appeal, that Lupin was, at the date on which the Lupin agreement was concluded, engaged in advanced negotiations with commercial partners for the distribution of a generic version of perindopril. Servier argues, however, that those negotiations were limited and were never completed.
317 It submits that the General Court also distorted the application at first instance in stating, in paragraph 736 of the judgment under appeal, that Servier did not, as regards Lupin, contest the assessment criteria applied by the Commission to establish the existence of potential competition.
318 In the second place, Servier complains that the General Court failed to take sufficient account of the patent-related and commercial situation with which Lupin was confronted.
319 It maintains that, as regards the patent-related situation, in paragraph 728 of the judgment under appeal, the General Court incorrectly held that Lupin’s perception of that situation was relevant only for the purpose of determining that undertaking’s intention to enter the market.
320 As regards the commercial difficulties, Servier criticises the General Court for having held, in paragraph 749 of the judgment under appeal, that Lupin had real and concrete possibilities of marketing its generic version of perindopril throughout the European Union, whereas it was present only in the United Kingdom. In that regard, Servier complains that the General Court distorted its line of argument by stating that it had merely relied on insurmountable commercial barriers, whereas Servier had submitted that Lupin, in the absence of commercial partners, could not enter the market in the near future, which, it claims, was subsequently confirmed by the facts.
321 The Commission disputes those arguments. (b) Findings of the Court
322 It must be stated that, under the guise of alleging that certain facts were substantially incorrect in the light of the documents in the file or that evidence was distorted, Servier is in fact challenging the General Court’s assessment of those facts and evidence in paragraphs 730, 748 and 749 of the judgment under appeal, which does not fall within the jurisdiction of the Court of Justice in appeal proceedings, in accordance with the case-law referred to in paragraph 58 of the present judgment.
323 As regards the claim that the General Court distorted Servier’s application at first instance, it must be observed that it is apparent from the clear and precise wording of paragraph 108 of that application that Servier contested the legal criteria applied by the Commission. Servier argued that that institution had misapplied the case-law relating to the assessment of potential competition. It maintained that, by finding in the decision at issue that the absence of insurmountable barriers encountered by manufacturers of generic medicines amounted to accepting the existence of real and concrete possibilities of entering the market, the Commission rendered the words ‘real and concrete’ meaningless and ‘adopted a legal test contrary to the case-law’.
324 However, leaving aside that distortion, it must be stated that the General Court did not confine itself to examining solely the question of the existence of possible insurmountable barriers to Lupin’s market entry, but also examined in detail, specifically in paragraphs 718 to 724 of the judgment under appeal, the preparatory steps taken by that undertaking with a view to entering the market, which supported the conclusion, in accordance with what has been held in paragraphs 79, 80 and 104 to 111 of the present judgment, that Lupin had the intention, the ability and, accordingly, real and concrete possibilities to make such an entry. Furthermore, in accordance with what has been held in paragraphs 118, 120 and 121 of the present judgment, the General Court did not err in law in holding, for the reasons set out in paragraphs 736 to 743 of the judgment under appeal, that Servier’s arguments relating to the difficulties encountered by Lupin in the context of the marketing authorisation procedures were not such as to call into question its status as a potential competitor. The distortion thus found therefore has no bearing on the validity of the operative part of the judgment under appeal.
325 In addition, it must be stated that Servier’s arguments concerning the assessment of the patent-related situation in respect of Lupin disregard the fact that the General Court did indeed take into account the patent-related obstacles and, to that extent, are based on a misreading of the judgment under appeal. As noted in paragraph 108 of the present judgment, the General Court did not consider, inter alia in paragraph 728 of the judgment under appeal, that the perception on the part of a manufacturer of generic medicines of the strength of a patent was entirely irrelevant for the purpose of assessing whether Servier and Lupin were potential competitors; rather, it considered that that perception could be relevant solely for the purpose of determining whether Lupin intended to enter the market and not for assessing its ability to make such an entry. As held in paragraphs 107 to 111 of the present judgment, the General Court did not err in law in that regard. Those arguments must therefore be rejected.
326 As regards Servier’s complaints relating to the regulatory and commercial obstacles which Lupin had to face, in particular those linked to the need to find commercial partners, and to the alleged distortion of Servier’s arguments at first instance concerning such commercial difficulties, Servier seeks, in fact, to call into question factual assessments made by the General Court in paragraphs 736 to 742 and 744 to 749 of the judgment under appeal which do not fall within the jurisdiction of the Court of Justice in appeal proceedings, in accordance with the case-law referred to in paragraph 58 of the present judgment.
327 The first part of the fifth ground of appeal must therefore be rejected. 2. The second part, relating to the characterisation as a restriction of competition by object
328 By the second part of its fifth ground of appeal, Servier, by reiterating the arguments developed in the context of its first ground of appeal, complains that the General Court erred in law in characterising the Lupin agreement as a restriction of competition by object. (a) The reverse payment (1) Arguments of the parties
329 Referring to the line of argument developed in the context of its first ground of appeal, Servier disputes the General Court’s reasoning according to which a commercial agreement concomitant with a patent dispute settlement agreement constitutes a reverse payment rendering that settlement agreement anticompetitive by object where that agreement was not concluded at arm’s length.
330 Servier objects to the General Court’s finding, in paragraph 827 of the judgment under appeal, that the payment of the sum of EUR 40 million to Lupin constituted a reverse payment. It submits that the comparison made by the General Court, in paragraph 816 of the judgment under appeal, between that sum and the profits expected by Lupin is irrelevant, since that sum represents consideration for patents and Lupin did not abandon entry to the market, but made such entry subject to compliance with certain conditions. According to Servier, even if that sum exceeded the value of the profits made by Lupin over two years, the Commission did not establish that that value was sufficient to induce Lupin to refrain indefinitely from entering the perindopril market.
331 The Commission disputes that line of argument. (2) Findings of the Court
332 It must be stated that Servier’s line of argument consists, in essence, in claiming that, contrary to what the General Court is alleged to have held, the payment of the sum of EUR 40 million which it made to Lupin in exchange for the assignment of intellectual property rights relating to three patent applications does not constitute a reverse payment, but rather legitimate consideration for the acquisition of those rights.
333 In that regard, it should be recalled that, although, as is apparent from paragraphs 163 and 166 of the present judgment, amounts which correspond to remuneration for the supply of goods or services to the manufacturer of originator medicines may prove to be justified, that is not the case where they are excessive and, therefore, not necessary for that purpose. In that situation, as held in paragraph 165 of the present judgment, it is necessary to ascertain whether the net gain from those amounts, including any justified costs, is sufficiently large actually to act as an incentive to a manufacturer of generic medicines to refrain from entering the market concerned; however, there is no requirement that the net gain should necessarily be greater than the profits which that manufacturer would have made if it had been successful in the patent proceedings which have been settled.
334 In the present case, the General Court found, in essence, in paragraphs 814 to 824 of the judgment under appeal, that the payment by Servier of the sum of EUR 40 million to Lupin in return for the assignment of three patent applications filed by Lupin had to be taken into account as part of the transfers of value which made it possible to determine that there had been a reverse payment constituting consideration for Lupin’s decision not to enter the market. In that regard, the General Court found, in paragraph 825 of that judgment, that Servier had not succeeded in producing evidence to justify the conclusion that that payment constituted a transaction carried out at arm’s length. Thus, taking the view, in essence, that the technology transferred did not justify the size of such an amount, the General Court concluded, in paragraph 827 of that judgment, that that payment was an inducement in the context of the settlement of the patent disputes between Servier and Lupin. In the light of the criteria referred to in the preceding paragraph of the present judgment, those assessments made by the General Court are not vitiated by any error of law.
335 In the absence of errors of law relied on by Servier that would allow the validity of those assessments made by the General Court to be called into question, it is necessary, as to the remainder, to reject Servier’s line of argument in so far as it seeks, in reality, to ask the Court of Justice to carry out a new appraisal of the facts and the evidence, which does not fall within its jurisdiction in appeal proceedings, in accordance with the case-law referred to in paragraph 58 of the present judgment.
336 Servier’s line of argument must therefore be rejected. (b) The harmfulness of the clauses of the Lupin agreement (1) Arguments of the parties
337 As regards the non-challenge clause provided for in the Lupin agreement, Servier criticises the General Court for having held, in paragraph 836 of the judgment under appeal, that that clause constituted a clear restriction of competition, without examining the context of that clause. According to Servier, the Lupin agreement had no effect on the challenge to the validity of the 947 patent by third parties such as Apotex, which, moreover, the General Court noted in relation to the agreements concluded between Servier and Krka. As regards Servier’s other patents, Servier asserts that Lupin had neither the intention nor the ability to challenge them, a fact which, it argues, the General Court failed to examine.
338 As regards the non-marketing clause provided for in the Lupin agreement, Servier disputes the assertion that that clause limited competition. It submits that, in paragraphs 843 and 844 of the judgment under appeal, the General Court failed to take into account the context of that clause, from which it is apparent that Lupin’s market entry in the United Kingdom was blocked by the 947 patent and the court injunctions obtained by Servier and by the fact that Lupin did not have marketing authorisations or commercial partners in that former Member State.
339 It maintains that, by contrast, the Lupin agreement provided that Lupin retained the possibility of entering the market for the perindopril covered by Servier’s patents, subject to the condition that Servier had previously authorised a third party to enter that market by means of a licence for its patents. It argues that such a possibility of early entry precludes the characterisation of the Lupin agreement as a restriction of competition by object. Servier submits that, in paragraph 954 of the judgment under appeal, the General Court expressly recognised that the anticompetitive effects of a non-marketing clause could be neutralised by the grant of a patent licence.
340 It maintains that, however, in paragraph 852 of the judgment under appeal, the General Court excluded such a possibility on account of the uncertain nature of such early entry. It claims that such a reason does not appear in the decision at issue. Servier submits that, by thus substituting its own grounds for those of the Commission, the General Court disregarded the limits of its powers and infringed the audi alteram partem rule. In any event, it argues, those grounds are manifestly incorrect and distort the facts.
341 As regards the clause envisaging the conclusion of an agreement for the supply of perindopril, Servier submits that it is pro-competitive, contrary to what the General Court held in paragraphs 858 and 859 of the judgment under appeal, since that clause allowed Lupin to enter the perindopril market. It maintains that that pro-competitive nature is not called into question either by the fact that Servier’s commitment to conclude a supply agreement with Lupin was subject to conditions or by the fact that no such agreement was ultimately concluded. As regards the absence of an express penalty in the event of failure to fulfil that commitment, Servier states that such a ground did not appear in the decision at issue. It argues that the only reason why no supply agreement was ultimately concluded was because Lupin managed to obtain a marketing authorisation for its perindopril.
342 As regards the assignment and licence clause provided for in the Lupin agreement, Servier submits that it could be construed as an implied licence on its own patents, and as a clause the effects of which would be pro-competitive. Servier complains that the General Court rejected that argument on the ground that the content of that clause was obscure and uncertain. It maintains that the first of those grounds, relating to the obscure nature of the content of that clause, is unfounded and does not appear in the decision at issue. It argues that the second of those grounds, based on the uncertain nature of the possibility that Servier would grant a patent licence to Lupin on account of the conditions referred to in paragraph 339 of the present judgment, does not call into question the pro-competitive nature of the assignment and licence clause.
343 The Commission disputes those arguments. (2) Findings of the Court
344 The General Court found, in paragraphs 836 and 837 of the judgment under appeal, that the competition-restricting nature of the non-challenge clause in the Lupin agreement was ‘clear’, since that clause provided that Lupin was required to refrain from challenging, in any of the EEA Member States, the validity of Servier’s patents protecting perindopril.
345 In paragraphs 839 to 864 of that judgment, the General Court found that the non-marketing clause provided for in the Lupin agreement prohibited Lupin from marketing a generic version of perindopril in any national market covered by that agreement, except in three situations: first, when Servier’s patents expired, were declared invalid or were revoked; second, if Servier authorised the marketing by a third party of a generic version produced by Servier; or, third, if Servier decided not to seek, or did not succeed in obtaining, an injunction against a third party marketing a generic version of perindopril which was not produced by Servier.
346 The General Court considered that, despite the ambiguities of certain clauses of the Lupin agreement as to whether the scope of that agreement extended to forms of perindopril other than that composed of the alpha crystalline form of erbumine covered by the 947 patent, the practical consequence of those clauses was to prohibit Lupin from entering the perindopril market as long as Servier’s patents remained in force, unless Servier previously authorised the entry of third parties to that market or unless those patents did not permit Servier to oppose such entry.
347 In paragraphs 858 to 860 of the judgment under appeal, the General Court dismissed as irrelevant the fact that the Lupin agreement provided for the future adoption of a supply agreement between Servier and Lupin, in essence because Servier was not obliged to conclude such an agreement and the failure to adopt such an agreement would not have significant legal consequences for the parties.
348 For the reasons set out in paragraphs 865 to 887 of the judgment under appeal, the General Court held that the restrictions thus imposed on Lupin’s conduct could validly be characterised by the Commission as a restriction of competition by object.
349 By its line of argument, Servier submits that the non-challenge, non-marketing and assignment and licence clauses, as well as the clause envisaging the conclusion of a supply agreement, provided for in the Lupin agreement, were not anticompetitive. It must be stated that that line of argument does not take into account the case-law referred to in paragraph 83 of the present judgment, from which it is clear that the test for determining whether an agreement such as the Lupin agreement constitutes a restriction of competition by object consists in ascertaining whether the transfers of value by the manufacturer of originator medicines in favour of the manufacturer of generic medicines constitute consideration for the latter manufacturer’s decision not to enter the market concerned. As is apparent from paragraphs 332 to 336 of the present judgment, the General Court did not err in law in holding that the Lupin agreement provided for a reverse payment in the amount of EUR 40 million.
350 It is also apparent from paragraph 293 of the present judgment 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, no longer to challenge that patent and not to enter that market are liable to have effects that restrict competition, since 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 (judgment of 30 January 2020, Generics (UK) and Others , C‑307/18, EU:C:2020:52, paragraph 81). Furthermore, the fact that an agreement limits the possibilities for a potential competitor to compete with the patent holder without, however, excluding all possibility of competition on the part of that competitor cannot invalidate the conclusion that such an agreement constitutes a restriction of competition by object.
351 Accordingly, since the General Court did not err in law in the grounds of the judgment under appeal summarised in paragraphs 344 to 348 of the present judgment, that line of argument must be rejected.
352 As to the remainder, with respect to Servier’s arguments summarised in paragraphs 339 to 342 of the present judgment, relating to the allegedly pro-competitive effects of the Lupin agreement, it is sufficient to point out that, in accordance with the case-law cited in paragraphs 73, 76 and 77 of the present judgment, such effects are not relevant in the context of the assessment of whether a restriction of competition by object exists. (c) The scope of the Lupin agreement (1) Arguments of the parties
353 Servier disputes the General Court’s assessment, made in paragraphs 875 to 877 of the judgment under appeal, that the Commission was justified in finding that the scope of the clauses restricting competition provided for in the Lupin agreement extended to products other than the perindopril composed of the alpha crystalline form of erbumine covered by the 947 patent, which was the subject of the disputes that were settled by means of that agreement, and could therefore justify the characterisation of that agreement as a restriction of competition by object.
354 It submits that, by thus endorsing the interpretation of the Lupin agreement most unfavourable to Servier, the General Court infringed the principle of the presumption of innocence and the case-law according to which, where the Court has a doubt, the benefit of that doubt must be given to the undertakings accused of the infringement.
355 Servier also maintains that the assessment, in paragraph 877 of the judgment under appeal, that non-marketing and non-challenge clauses provided for in a patent dispute settlement agreement may be characterised as a restriction of competition by object on the sole ground that they exceed the scope of a ‘specifically identified patent’ is legally incorrect. It argues that such an agreement could lawfully cover a set of patents in order to avoid future disputes. According to Servier, in the present case, the Lupin agreement in no way prevented Lupin from marketing versions of perindopril which did not infringe the 947 patent.
356 The Commission disputes those arguments. (2) Findings of the Court
357 In paragraph 877 of the judgment under appeal, the General Court noted that the presence, in a settlement agreement relating to a patent dispute, of non-challenge and non-marketing clauses the scope of which exceeds the scope of that patent ‘clearly reveals a degree of harm to the proper functioning of normal competition sufficient for their inclusion to be classified as a restriction by object, without its even being necessary to prove, in addition, the existence of an inducement’.
358 In paragraph 878 of that judgment, the General Court stated that, even if the Commission had wrongly found that the scope of the Lupin agreement exceeded that of the 947 patent, such an error would not be capable of calling into question the Commission’s finding of a restriction of competition by object, since that finding is based in essence on the existence of a reverse payment which induced Lupin not to enter the market concerned. It therefore follows from that assessment, and from the fact that Servier’s complaints seeking to dispute the existence of such a payment in the present case have been rejected in paragraphs 329 to 336 of the present judgment, that the considerations set out in paragraph 877 of the judgment under appeal were included purely for the sake of completeness. It follows that Servier’s complaints directed against paragraph 877 of that judgment are ineffective and must be rejected.
359 It follows from the foregoing that the second part of the fifth ground of appeal must be rejected. 3. The third part, relating to the end date of the infringement (a) Arguments of the parties
360 By the third part of its fifth ground of appeal, Servier complains that the General Court erred in law in determining the end date of the infringement relating to the Lupin agreement.
361 Servier states that it challenged, in its action at first instance, the determination of that date by arguing that the decision at issue was inconsistent and failed to state reasons in that regard. It submits that, as regards France, the Commission set the end of the infringement on the date on which another manufacturer of generic medicines, Sandoz AG, entered that market in September 2008. It maintains that, by contrast, as regards Belgium, the Czech Republic, Ireland and Hungary, the Commission disregarded the date on which Sandoz entered those markets and found that that infringement had ended with the adoption of the EPO decision of 6 May 2009.
362 According to Servier, by failing to censure that inconsistency and that manifest error of assessment, the General Court erred in law. It submits that the General Court relied, in paragraph 898 of the judgment under appeal, on the ambiguity of the wording of the Lupin agreement and, in particular, in paragraphs 899 and 903 of that judgment, on the fact that the parties continued to apply the Lupin agreement after Sandoz had entered the perindopril market. It argues that such reasons do not appear in the decision at issue. The General Court thus substituted its own reasons for those of the Commission. According to Servier, the reasons relied on by the General Court are incorrect. It maintains that if Lupin did not enter the market, that is because it did not possess the necessary authorisations to do so.
363 Servier submits that, in accordance with the terms of the Lupin agreement, Sandoz’s market entry had the effect of releasing Lupin from its non-marketing obligation, as is apparent from recital 2127 of the decision at issue as regards the market in France. It argues that, for the same reason, the General Court should have recognised that Sandoz’s entry also had had the effect of bringing to an end the infringement relating to the Lupin agreement in Belgium in July 2008, in the Czech Republic in January 2009, in Ireland in June 2008 and in Hungary in December 2008.
364 Servier asks the Court of Justice to annul Article 7(5)(b) of the decision at issue and to reduce the amount of the fine imposed on it from EUR 37 102 100 to EUR 34 745 100 accordingly.
365 The Commission disputes those arguments.
366 According to the Commission, the interpretation of the non-marketing clause provided for in the Lupin agreement which was set out in recital 1039 of the decision at issue is based on Servier’s statements. It contends that, in accordance with that interpretation, that clause continued to produce its effects after the entry into the markets in Belgium, the Czech Republic, Ireland and Hungary of a generic version of perindopril produced by Sandoz.
367 It maintains that, after the launch by Sandoz, on 17 September 2008, of that medicinal product, which did not contain any of the crystals protected by the 947 patent, Lupin asked Servier to confirm whether it could launch its generic medicine. According to the Commission, in its reply of 31 March 2009, Servier did not respond positively to that request. It contends that, in those circumstances, Lupin’s market entry became possible only as from the EPO decision of 6 May 2009. (b) Findings of the Court
368 By its line of argument, Servier submits, in essence, that, by refusing to consider that the infringement relating to the Lupin agreement had ended in the markets in Belgium, the Czech Republic, Ireland and Hungary on the date on which a generic version of perindopril produced by Sandoz entered those markets, as it had done in respect of the French market, the Commission vitiated the decision at issue with contradictory reasoning and a manifest error of assessment, which the General Court should have censured.
369 In that regard, it is apparent from recital 3136 of the decision at issue that the Commission considered that the infringements of Article 101 TFEU had started on the date of conclusion of the agreements at issue and had ended on ‘the date as of which the generic competitors [had been] able to engage in competitive behaviour’. According to Article 5 of that decision, the infringement relating to the Lupin agreement started on 30 January 2007 and ended on 6 May 2009, the date of adoption of the decision by which the EPO revoked the 947 patent, with the exception, however, of five national markets. Those markets include the market in France, in respect of which the Commission considered that that infringement had ended on 16 September 2008, the date on which a generic version of perindopril produced by Sandoz entered that market.
370 In recital 410 of the decision at issue, the Commission noted that Sandoz had launched its generic perindopril in Belgium in July 2008, in the Czech Republic in January 2009, in Ireland in June 2008 and in Hungary in December 2008.
371 In the context of a plea at first instance relating to the fines imposed on it under Article 101 TFEU, Servier contested the duration of the infringement relating to the Lupin agreement. It claimed that the Commission should have concluded, as it had done in respect of the French market, that that infringement had ended in Belgium, the Czech Republic, Ireland and Hungary on the date on which Sandoz entered those markets.
372 The General Court held, in paragraph 894 of the judgment under appeal, that that agreement could be interpreted as allowing ‘the market entry of Lupin with its own products where a generic “Product” which is not produced by Servier has entered the market without breaching an injunction and where an application for an injunction lodged by Servier has not yet been dismissed’.
373 However, due to the ambiguous wording of the definition of the term ‘Product’ used in the Lupin agreement, the General Court considered that there was no clear answer to the question whether Sandoz’s entry to a market with a product which was not composed of the alpha crystalline form of erbumine protected by the 947 patent could have the consequence of terminating the effects of the non-marketing clause. According to the General Court, those uncertainties were such as to deter Lupin from entering the markets concerned, despite the arrival of the generic version of Sandoz’s perindopril on those markets.
374 The General Court held, in paragraph 902 of the judgment under appeal, that ‘the fact that the non-marketing clause … remained in force, thus indicating continued consensus between the parties - possibly contrary to the interpretation of the conditions of application of the contractual clause, which, a posteriori, might be adopted, in particular, by a court -, was sufficient to allow the Commission to find that the consensus between Servier and Lupin, and thus the infringement, continued despite Sandoz’s entries to the market’.
375 Lastly, the General Court observed, in paragraph 903 of the judgment under appeal, that ‘in any event, … the non-marketing clause continued to be applied by Servier and Lupin following the successive entries of Sandoz to the four markets in question’. Since an infringement may be found to continue beyond the period during which an agreement is formally in force, where the undertakings concerned continued to engage in prohibited conduct, the General Court rejected Servier’s arguments, for the reasons set out in paragraphs 905 and 906 of that judgment.
376 In the present case, as recalled in paragraph 369 of the present judgment, the Commission, in the decision at issue, took as a criterion for determining the end of the infringement period not the date as of which the unlawful conduct had ceased as such, but rather ‘the date as of which the generic competitors [had been] able to engage in competitive behaviour’. Consequently, in the absence of any indication to the contrary in the grounds of the judgment under appeal, it must be held that the situation resulting from the arrival on the national markets of the generic version of perindopril produced by Sandoz raised, in all the markets concerned, the question whether the non-marketing clause concerned continued to produce its effects.
377 However, in the judgment under appeal, the General Court did not put forward any explanation as to the reasons why the French market had been treated differently, in recital 2127 of the decision at issue, from the Belgian, Czech, Irish and Hungarian markets. It is true that in paragraph 900 of the judgment under appeal the General Court referred to uncertainties, even with regard to the French market, as to the date on which Lupin was free to enter that market on account of Sandoz’s entry to that market, but it did not draw any conclusions therefrom as regards the date on which the infringement ended on that market. Thus, the judgment under appeal does not make it possible to understand why the Commission did not, according to the General Court, act unlawfully in treating the French market differently from the four other markets referred to above.
378 Although that question, which is linked to the situation resulting from Sandoz’s arrival on the market, therefore arose in comparable terms in France, Belgium, the Czech Republic, Ireland and Hungary, the General Court did not uphold Servier’s plea for annulment alleging contradictory reasoning in the decision at issue.
379 In the light of the foregoing, it must be held that the judgment under appeal is vitiated by an error of law and that the third part of the fifth ground of appeal must be upheld. F. The seventh ground of appeal, relating to the fines
380 By its seventh ground of appeal, Servier disputes the General Court’s assessments regarding its applications for annulment of the fines imposed on it and regarding the calculation of the amounts of those fines. That ground of appeal consists of two parts. 1. The first part, relating to breach of the principle of legality of criminal offences and penalties (a) Arguments of the parties
381 According to Servier, by holding, in paragraph 1660 of the judgment under appeal, that Servier ‘should have expected, if necessary after taking appropriate legal advice, its conduct to be declared incompatible with the EU competition rules’, the General Court infringed the principle of legality of criminal offences and penalties enshrined in Article 49(1) of the Charter of Fundamental Rights of the European Union, failed to fulfil its obligation to state reasons, and ruled on the basis of a ground contradictory to that set out in paragraph 1666 of that judgment, according to which ‘the unlawful nature [of the agreements covered by the decision at issue] might not have been evident to an outside observer such as the Commission or lawyers specialising in the fields in question’.
382 Servier submits that, under that principle, the Commission cannot impose fines in a situation which is novel, characterised by a lack of previous decisions or case-law, and complex. According to Servier, the present case was both novel and complex. It maintains that the novelty of that case is evidenced by a statement made by the head of unit responsible for the Commission’s investigation which led to the adoption of the decision at issue, by recitals 3091, 3092 and 3107 of that decision, and by the assessments made by the General Court in paragraph 1660 of the judgment under appeal.
383 Servier argues that the complexity of the economic and legal questions raised is apparent in particular from the exceptional length of the decision at issue and from the statements to that effect made by the Commission to the Registrar of the General Court in the proceedings at first instance. It submits that that complexity led the Commission, in 2014, to amend the 2004 Guidelines on technology transfer agreements in order to clarify that settlement agreements could be prohibited under Article 101(1) TFEU.
384 Servier contests the judgment under appeal on the ground that the General Court distorted the facts by suggesting that it would have sufficed to take appropriate legal advice in order to identify the unlawful nature of its conduct under Article 101 TFEU.
385 The Commission disputes those arguments. (b) Findings of the Court
386 According to the case-law of the Court of Justice, the principle of legality of criminal offences and penalties requires the law to give a clear definition of offences and the penalties which they attract. That requirement is satisfied where the individual concerned is in a position to ascertain from the wording of the relevant provision and, if need be, with the assistance of the courts’ interpretation of it, what acts and omissions will make him or her criminally liable (judgment of 22 May 2008, Evonik Degussa v Commission and Council , C‑266/06 P, EU:C:2008:295, paragraph 39 and the case-law cited).
387 The principle that offences and penalties must be defined by law cannot therefore be interpreted as precluding the gradual, case-by-case clarification of the rules on criminal liability by judicial interpretation, provided that the result was reasonably foreseeable at the time the offence was committed, especially in the light of the interpretation put on the provision in the case-law at the material time (judgment of 22 October 2015, AC-Treuhand v Commission , C‑194/14 P, EU:C:2015:717, paragraph 41 and the case-law cited).
388 The scope of the notion of foreseeability depends to a considerable degree on the content of the text in issue, the field it covers and the number and status of those to whom it is addressed. A law may still satisfy the requirement of foreseeability even if the person concerned has to take appropriate legal advice to assess, to a degree that is reasonable in the circumstances, the consequences which a given action may entail. This is particularly true in relation to persons carrying on a professional activity, who are used to having to proceed with a high degree of caution when pursuing their occupation. Such persons can therefore be expected to take special care in evaluating the risk that such an activity entails (judgment of 22 October 2015, AC-Treuhand v Commission , C‑194/14 P, EU:C:2015:717, paragraph 42 and the case-law cited).
389 In the present case, in paragraphs 1656 to 1658 of the judgment under appeal, the General Court recalled that case-law of the Court of Justice. In paragraphs 1659 to 1665 of that judgment, the General Court stated, in essence, that, in view of the scope of the prohibition laid down in Article 101(1) TFEU, Servier could not have been unaware that, by paying the manufacturers of generic medicines not to enter the perindopril market, it was engaging in conduct prohibited by that provision. It should be pointed out in that regard that, for the reasons set out in paragraph 144 of the present judgment, the allegedly novel nature of the approach consisting in characterising the conduct at the origin of the infringements found as restrictions of competition by object is not liable to call that characterisation into question.
390 In addition, as the General Court pointed out, in paragraphs 1666 and 1667 of the judgment under appeal, the fact that the agreements at issue and their context were complex and might have given rise to certain difficulties during the administrative procedure, thereby justifying the length of that procedure and of the decision at issue, is not such as to call into question the fact that the undertakings involved could not have been unaware of the unlawful nature of those agreements. As is apparent from a reading of the judgment under appeal as a whole, the very object of those agreements was to remove Servier’s potential competitors, namely the manufacturers of generic medicines, from the perindopril market by making reverse payments, a method which is incompatible with free competition.
391 In those circumstances, the first part of the seventh ground of appeal must be rejected. 2. The second part, relating to breach of the principle of proportionality (a) Arguments of the parties
392 By the second part of its seventh ground of appeal, Servier criticises the judgment under appeal in so far as it rejected its plea at first instance alleging breach of the principle of proportionality, by which that undertaking challenged the setting of the basic amount of the fine for the infringement of Article 101 TFEU at 11% of the value of its sales.
393 It submits that the General Court failed to take into account the complex and novel nature of the situation at issue and a number of other contextual factors which would have justified a reduction in the amount of the fine imposed on Servier.
394 It maintains that, by dismissing, in paragraph 1797 of the judgment under appeal, the relevance of the judicial decisions recognising the validity of the 947 patent, the General Court disregarded the patent-related context of the case. Servier argues that it was paradoxically penalised more heavily on account of the fact that the EPO decision of 27 July 2006 had found in its favour, thereby prolonging the duration of the proceedings relating to the validity of the 947 patent. It maintains that it should not have been penalised as severely as if that patent had been invalidly granted.
395 Servier maintains that, in order to assess the gravity of the infringements, in recital 3130 of the decision at issue, the Commission took as a basis the size of Servier’s market shares, which it estimated at over 90%. According to Servier, in paragraph 1602 of the judgment under appeal, the General Court held that that estimation, which was based on an erroneous definition of the relevant market, was incorrect. It argues that the General Court failed, however, to draw the appropriate conclusions from that error with respect to the calculation of the amount of the fine. It submits that that court merely referred, in paragraph 1954 of the judgment under appeal, to a reading of paragraphs 1948 to 1953 of that judgment, without, however, stating the reasons why it had not reduced that amount. It maintains that, in so doing, the General Court infringed the principle of proportionality and its obligation to state reasons.
396 According to Servier, the General Court also failed to take into consideration the fact that the agreements at issue were not secret. It maintains that, in other cases, that fact led the Commission to apply a coefficient reflecting the gravity of the infringement which was lower than the one used in the present case.
397 Apart from the fact that those agreements did not delay the entry of generic medicines to the market, Servier submits that they could not be regarded, in paragraph 1883 of the judgment under appeal, as constituting an extreme form of market sharing and of limitation of production. It argues that such an assessment contradicts the one set out in paragraph 1666 of that judgment, according to which the unlawful nature of those agreements might not have been evident.
398 The Commission disputes those arguments. (b) Findings of the Court
399 At the outset, it is necessary to reject the argument that the General Court failed to take into account, for the purpose of assessing the gravity of the infringements, their allegedly novel nature. It should be recalled, in that regard, that, for the reasons set out in paragraph 144 of the present judgment, that fact has no bearing on the characterisation of the agreements at issue as a restriction of competition by object. Furthermore, as noted in paragraph 390 of the present judgment, the very object of those agreements was to remove Servier’s potential competitors from the market.
400 In addition, by relying on the importance of the rights conferred by the patents in order to contest paragraph 1797 of the judgment under appeal, Servier merely repeats its claim that the General Court failed to take into consideration the alleged recognition by the parties of the validity of the 947 patent. The General Court did not err in law in confirming the Commission’s analysis that the agreements at issue had as their object, in addition to the settlement of patent disputes, the exclusion of competitors from the market, which constitutes an extreme form of market sharing and of limitation of production.
401 Furthermore, contrary to what Servier claims and in the light of the object of the agreements at issue, the General Court did not err in law in holding, in paragraphs 1786 to 1791 of the judgment under appeal, that the Commission had been entitled, for the purpose of calculating the amount of the fines, to find that Servier had intentionally committed infringements of Article 101 TFEU.
402 As regards the assessment of Servier’s market shares, it must be held that the General Court did not err in law or distort the decision at issue in finding, in paragraph 1951 of the judgment under appeal, that the Commission had taken into account the fact that Servier had committed several infringements relating to the same product, in the same geographic areas and during the same periods of time. In order to avoid imposing a disproportionate penalty, the Commission decided to limit, in respect of each infringement, the proportion of the value of sales made by Servier taken into account for the purpose of determining the basic amount of the fine. That correction led to an average reduction of 54.5% in the overall values of sales taken into account in respect of the various infringements of Article 101 TFEU.
403 In the light of those reductions, the General Court was entitled to hold, in paragraph 1954 of the judgment under appeal, that the amounts of the fines were not disproportionate, even though the Commission had considered that Servier possessed a very high market share on the basis of a definition of the relevant market which the General Court held to be incorrect.
404 As regards Servier’s claim that the amount of the fines should have been reduced in view of the fact that the agreements at issue were not secret and had not delayed the market entry of generic versions of perindopril, it is sufficient to note that Servier is in fact asking the Court of Justice to carry out a new appraisal of the elements of the dispute at first instance. Such a request does not fall within the jurisdiction of the Court of Justice in appeal proceedings. Indeed, it is not for the Court of Justice, when ruling on questions of law in the context of an appeal, to substitute, on grounds of fairness, its own assessment for that of the General Court exercising its unlimited jurisdiction to rule on the amount of fines imposed on undertakings for infringements of EU law (judgment of 22 November 2012, E.ON Energie v Commission , C‑89/11 P, EU:C:2012:738, paragraph 125 and the case-law cited).
405 In the light of those considerations, the second part of the seventh ground of appeal and, as a consequence, that ground of appeal in its entirety, must be rejected. G. Conclusion on the appeal
406 Since the third part of the fifth ground of appeal has been upheld, it is necessary, in accordance with the form of order sought by Servier, to set aside point 5 of the operative part of the judgment under appeal, in so far as it rejects the complaints of Servier’s plea at first instance relied on in the alternative concerning the duration of the alleged infringement and the calculation of the amount of the fine for the infringement relating to the Lupin agreement. As to the remainder, the appeal is dismissed. VII. The action before the General Court
407 In accordance with the first paragraph of Article 61 of the Statute of the Court of Justice of the European Union, if the decision of the General Court is quashed, the Court of Justice may itself give final judgment in the matter, where the state of the proceedings so permits.
408 As is apparent from paragraph 891 of the judgment under appeal, in its action at first instance, Servier put forward, by a plea in the alternative, complaints disputing the duration of the infringement relating to the Lupin agreement, on the ground that the Commission should have concluded, as it had done in respect of the French market, that that infringement had ended in Belgium, the Czech Republic, Ireland and Hungary on the date on which Sandoz entered those markets.
409 Those complaints were the subject of an exchange of arguments before the General Court and 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 in Case T‑691/14 permits final judgment to be given as regards those complaints and that it is appropriate to give final judgment on them.
410 For the reasons set out in paragraphs 369 to 378 of the present judgment, the complaint alleging an error of law by the General Court, which did not find that the reasoning relating to the end of the infringement arising from the Lupin agreement on the French market, on the one hand, and on the Belgian, Czech, Irish and Hungarian markets, on the other, was contradictory, must be declared well founded.
411 Accordingly, Article 5 of the decision at issue must be annulled in so far as it provides that the end date of the infringement relating to the Lupin agreement was 6 May 2009 as regards Belgium, the Czech Republic, Ireland and Hungary. Article 7(5)(b) of that decision must also be annulled in so far as it sets the amount of Servier’s fine in respect of its participation in the Lupin agreement at EUR 37 102 100.
412 Having found that the decision at issue is unlawful, the Court may, in the exercise of its unlimited jurisdiction, substitute its own appraisal for the Commission’s and, consequently, cancel, reduce or increase the fine imposed. That power is exercised by taking into account all of the factual circumstances (judgment of 12 November 2014, Guardian Industries and Guardian Europe v Commission , C‑580/12 P, EU:C:2014:2363, paragraph 78 and the case-law cited).
413 Having regard to the fact that the legality of Article 5 of the decision at issue was not contested before the Courts of the European Union in so far as that article had determined that the infringement resulting from the Lupin agreement had ended on 16 September 2008 in France, on account of Sandoz’s entry to the market of that Member State on that date, it must be held that that fact has been definitively established. It follows that the contradictory reasoning in the decision at issue which leads the Court to annul Article 5 of that decision, in so far as it provides that the end date of the infringement which it has found was 6 May 2009 as regards Belgium, the Czech Republic, Ireland and Hungary, can be corrected only by applying the same reasoning as that adopted with respect to France, for the purpose of setting the amount of the fine relating to the infringement resulting from the Lupin agreement.
414 It must therefore be held, for the purpose of setting the amount of that fine, in accordance with the information set out in recital 410 of the decision at issue, that the infringement relating to the Lupin agreement ended in Belgium in July 2008, in the Czech Republic in January 2009, in Ireland in June 2008 and in Hungary in December 2008.
415 It follows from that finding that the duration to be taken into account for the purpose of determining the amount of the fine must be set at 1.4 years for Belgium, 1.9 years for the Czech Republic, 1.3 years for Ireland and 1.8 years for Hungary.
416 In the context of the present proceedings, Servier has submitted to the Court a calculation in the form of a table, setting out each of the stages of the method followed by the Commission to determine the amount of the fine for the infringement relating to the Lupin agreement. That calculation includes the revised infringement periods referred to in the preceding paragraph of the present judgment and is based on the data provided by the Commission in the proceedings at first instance. That calculation results in the corrected amount of that fine being set at EUR 34 745 100.
417 Since the Commission has not contested that amount or that calculation method, which corresponds, moreover, to the method which it had itself adopted in the decision at issue, it is appropriate, in the light of all the factual and legal circumstances of the present case, to set the amount of the fine imposed on Servier in Article 7(5)(b) of the decision at issue at EUR 34 745 100. Costs
418 Under Article 184(2) of the Rules of Procedure, where the appeal is well founded and the Court itself gives final judgment in the case, the Court is to make a decision as to the costs.
419 Under Article 138(1) of those rules, applicable to the appeal proceedings by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.
420 Under Article 138(3) of those rules, where each party succeeds on some and fails on other heads, the parties are to bear their own costs. However, if it appears justified in the circumstances of the case, the Court may order that one party, in addition to bearing its own costs, pay a proportion of the costs of the other party.
421 In the present case, Servier has applied for the Commission to be ordered to pay the costs relating to the appeal proceedings and the Commission has been unsuccessful, in part, in its form of order sought at the appeal stage and, in part, in its form of order sought at first instance.
422 Since the appeal has been upheld in part, each party must be ordered to bear its own costs relating to both the proceedings at first instance and to the appeal.
423 Under Article 184(4) of the Rules of Procedure, where the appeal has not been brought by an intervener at first instance, that intervener may not be ordered to pay costs in the appeal proceedings unless it participated in the written or oral part of the proceedings before the Court of Justice. Where an intervener at first instance takes part in the proceedings, the Court may decide that that intervener is to bear its own costs.
424 Since EFPIA took part in the proceedings before the Court of Justice, it is appropriate in the circumstances of the present case to order it to bear its own costs.
425 Article 140(1) of the Rules of Procedure, which applies to the appeal proceedings by virtue of Article 184(1) thereof, provides that the Member States which have intervened in the proceedings are to bear their own costs.
426 In the present case, the United Kingdom must bear its own costs. On those grounds, the Court (First Chamber) hereby: 1. Sets aside point 5 of the operative part of the judgment of the General Court of the European Union of 12 December 2018, Servier and Others v Commission (T ‑ 691/14, EU:T:2018:922), in so far as it rejects the complaints of the plea at first instance of Servier SAS, Servier Laboratories Ltd and Les Laboratoires Servier SAS, relied on in the alternative as regards the duration of the infringement period and the calculation of the amount of the fine for the infringement referred to in Article 5 of Commission Decision C(2014) 4955 final of 9 July 2014 relating to a proceeding under Article 101 and Article 102 [TFEU] (Case AT.39612 - Perindopril (Servier)); 2. Annuls Article 5 of Decision C(2014) 4955 final, in so far as it provides that the end date of the infringement which it finds was 6 May 2009 as regards Belgium, the Czech Republic, Ireland and Hungary; 3. Annuls Article 7(5)(b) of Decision C(2014) 4955 final, in so far as it sets the amount of the fine imposed on Servier SAS and Les Laboratoires Servier SAS, jointly and severally liable, at EUR 37 102 100; 4. Sets the amount of the fine imposed on Servier SAS and Les Laboratoires Servier SAS, jointly and severally liable, for the infringement found in Article 5 of Decision C(2014) 4955 final at EUR 34 745 100; 5. Dismisses the appeal as to the remainder; 6. Orders Servier SAS, Servier Laboratories Ltd and Les Laboratoires Servier SAS to bear their own costs relating to both the proceedings at first instance and the appeal proceedings; 7. Orders the European Commission to bear its own costs relating to both the proceedings at first instance and the appeal proceedings; 8. Orders the European Federation of Pharmaceutical Industries and Associations (EFPIA) to bear its own costs relating to both the proceedings at first instance and the appeal proceedings; 9. Orders the United Kingdom of Great Britain and Northern Ireland to bear its own costs. [Signatures] * Language of the case: French.