Source: EURLEX
Language: en
Format: md

JUDGMENT OF THE COURT (First Chamber)

27 June 2024 ([\*](#Footnote*))

(Appeal – Competition – Pharmaceutical products – Market for perindopril – Article 101 TFEU – Agreements, decisions and concerted practices – Potential competition – Restriction of competition by object – Strategy to delay the market entry of generic versions of perindopril – Patent dispute settlement agreement)

In Case C‑164/19 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 22 February 2019,

**Niche Generics Ltd,** established in Hitchin (United Kingdom), represented initially by F. Carlin, Barrister, M. Healy, S. Mobley and H. Sheraton, Solicitors, B. Hoorelbeke, advocaat, and A. Robertson KC, and subsequently by F. Carlin, Barrister, S. Mobley and H. Sheraton, Solicitors, B. Hoorelbeke, advocaat, and A. Robertson KC,

appellant,

the other party to the proceedings being:

**European** **Commission,** represented initially by F. Castilla Contreras, B. Mongin and C. Vollrath, acting as Agents, and by S. Kingston, Senior Counsel, and subsequently by F. Castilla Contreras, B. Mongin, J. Norris and C. Vollrath, acting as Agents, and lastly by F. Castilla Contreras, J. Norris and C. Vollrath, acting as Agents,

defendant at first instance,

supported by:

**United Kingdom of Great Britain and Northern Ireland**, represented initially by D. Guðmundsdóttir, acting as Agent, and subsequently by S. Fuller, acting as Agent,

intervener in the appeal,

THE COURT (First Chamber),

composed of A. Arabadjiev (Rapporteur), President of the Chamber, K. Lenaerts, President of the Court, acting as Judge of the First Chamber, P.G. Xuereb, A. Kumin and I. Ziemele, Judges,

Advocate General: J. Kokott,

Registrar: M. Longar and R. Şereş, Administrators,

having regard to the written procedure and further to the hearing on 20 and 21 October 2021,

having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,

gives the following

**Judgment**

1        By its appeal, Niche Generics Ltd (‘Niche’) asks the Court of Justice to set aside the judgment of the General Court of the European Union of 12 December 2018, *Niche Generics* v *Commission* (T‑701/14, ‘the judgment under appeal’, EU:T:2018:921), by which the General Court dismissed its action seeking annulment, in so far as concerns Niche, 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’), and to cancel or reduce the fine imposed on it by that decision.

**Background to the dispute**

2        The background to the dispute, as apparent in particular from paragraphs 1 to 26 of the judgment under appeal, can be summarised as follows.

***Perindopril***

3        Servier SAS is the parent company of the Servier pharmaceutical group, which includes Les Laboratoires Servier SAS and Servier Laboratories Ltd (individually or jointly, ‘Servier’). Les Laboratoires Servier is specialised in developing originator medicines and its subsidiary Biogaran SAS in the development of generic medicines.

4        Servier developed perindopril, a medicinal product primarily intended for the treatment of hypertension and heart failure. That medicinal product is one of the angiotensin-converting enzyme inhibitors. The active ingredient of perindopril takes the form of a salt. The salt used initially was erbumine.

5        Patent EP0049658, relating to the active ingredient of perindopril, was filed with the European Patent Office (EPO) by a company in the Servier group on 29 September 1981. That patent was due to expire on 29 September 2001, but 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.

6        On 16 September 1988, Servier filed a number of patents before 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.

7        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. Servier also filed with the EPO patent EP1294689, relating to the beta crystalline form of perindopril erbumine and the process for its manufacture, and patent EP1296948 (‘the 948 patent’), relating to the gamma crystalline form of perindopril erbumine and the process for its manufacture.

8        On 6 July 2001, Servier also filed national patent applications in several Member States before they were parties to the Convention on the Grant of European Patents, which was signed in Munich on 5 October 1973 and entered into force on 7 October 1977. Servier filed, for example, patent applications relating to the 947 patent in Bulgaria (BG 107 532), the Czech Republic (PV 2003-357), Estonia (P200300001), Hungary (HU225340), Poland (P348492) and Slovakia (PP0149-2003). Those patents were granted on 16 May 2006 in Bulgaria, on 17 August 2006 in Hungary, on 23 January 2007 in the Czech Republic, on 23 April 2007 in Slovakia and on 24 March 2010 in Poland.

***Niche’s perindopril-related activities***

9        On 26 March 2001, Bioglan Generics Ltd (‘Bioglan’), a manufacturer of generic medicines established in the United Kingdom, and Medicorp Technologies India Ltd (‘Medicorp’), a manufacturer of generic medicines established in India, concluded a development and licensing agreement with a view to marketing a generic version of perindopril in the European Union. Medicorp was responsible for developing and supplying the active ingredient of that medicinal product. Bioglan was responsible for the business strategy and for obtaining marketing authorisations for that medicinal product.

10      In 2002, Unichem Laboratories Ltd (‘Unichem’), a medicines manufacturer established in India, and a number of Bioglan’s management shareholders set up Niche. The capital of that company was held as to 60% by Unichem and as to 40% by those shareholders.

11      On 15 April 2002, Niche took over Bioglan’s assets and business commitments.

12      On 27 March 2003, Medicorp and Unichem concluded an agreement under which Medicorp was responsible for developing and supplying the active ingredient of a generic version of perindopril and Unichem was to produce that medicine in tablet form.

13      On 20 May 2003, Matrix Laboratories Ltd (‘Matrix’), a company established in India and specialising in the production of active ingredients for the manufacture of generic medicines, merged with Medicorp and supplied an initial batch of a generic version of the active ingredient of perindopril and the file needed in order for Niche to prepare the marketing authorisation applications.

14      During the autumn of 2004, Servier considered acquiring Niche. On 10 January 2005, on completion of the first phase of a due diligence, Servier submitted a preliminary non-binding offer to acquire the capital of Niche. On 31 January 2005, after the second phase of that due diligence, Servier informed Niche verbally that it no longer wished to proceed with that acquisition.

15      On 22 June 2005, Matrix informed Niche that the agreement of 26 March 2001 was suspended with immediate effect until 16 September 2008, the expiry date of the 339, 340 and 341 patents.

16      In December 2006, Unichem acquired the whole of Niche’s capital.

***Disputes relating to perindopril***

17      Between 2003 and 2009, a number of disputes arose between Servier and manufacturers preparing to market a generic version of perindopril.

*The EPO decisions*

18      In 2004, 10 manufacturers of generic medicines, including Niche, 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.

19      On 11 August 2004, Niche filed an opposition against the 948 patent before the EPO.

20      On 27 July 2006, the EPO Opposition Division confirmed the validity of the 947 patent. That decision was challenged before the EPO Technical Board of Appeal. 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.

*The decisions of the national courts*

21      The validity of the 947 patent has been challenged before certain national courts by manufacturers of generic medicines, and Servier has brought actions for infringement and applications for interim injunctions against those manufacturers. Most of those proceedings were closed before the courts seised could give a final ruling on the validity of the 947 patent as the result of settlement agreements entered into by Servier, between 2005 and 2007, with a number of those manufacturers of generic medicines.

22      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 to market a generic version of perindopril on the UK market. On 8 August 2006, Servier obtained 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, thus allowing that undertaking 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.

23      In the Netherlands, on 13 November 2007, Katwijk Farma BV, a subsidiary of Apotex, brought an action before a court of that Member State seeking a declaration of invalidity 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 specialising in the manufacture of generic medicines, declared the 947 patent invalid in respect of the Netherlands. Following that decision, Servier and Katwijk Farma withdrew their claims.

*The dispute between Servier and Niche*

24      On 25 June 2004, Servier brought an action against Niche before the High Court of Justice (England & Wales), Chancery Division (patents court) for infringement of the 339, 340 and 341 patents, and Niche, by way of counterclaim, sought a declaration of invalidity of the 947 patent.

***The Niche agreement***

25      On 8 February 2005, Servier concluded an agreement with Niche and Unichem to settle the dispute referred to in the preceding paragraph of the present judgment and the opposition proceedings relating to the 947 and 948 patents then pending before the EPO (‘the Niche agreement’). Niche accordingly withdrew from the opposition relating to the 947 patent on 9 February 2005 and that relating to the 948 patent on 14 February 2005.

26      That agreement contained, first, a ‘non-marketing’ clause, by which Niche and Unichem 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, a ‘non-challenge’ clause, by which those undertakings undertook to refrain from or withdraw from any action seeking to challenge the validity of those patents or to obtain declarations of non-infringement.

27      In return, Servier undertook, first, not to bring any actions for infringement 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. It was provided that that compensation would give rise to payment of the sum of 11.8 million pounds sterling (GBP) (EUR 17 161 140) to Niche. The Niche agreement 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.

**The decision at issue**

28      On 9 July 2014, the Commission adopted the decision at issue.

29      In Article 1 of that decision, the Commission found that Niche and Unichem had infringed Article 101 TFEU, by participating in an agreement with Servier and Biogaran 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 that infringement had started on 8 February 2005, except as regards Latvia, where it had started on 1 July 2005, Bulgaria and Romania, where it had started on 1 January 2007, and Malta, where it had started on 1 March 2007; and that the infringement in question ended on 15 September 2008, except as regards the United Kingdom, where it ended on 6 July 2007, and the Netherlands, where it ended on 12 December 2007.

30      In Article 7(1)(a) of the decision at issue, the Commission imposed a fine of EUR 13 968 773 on Niche and Unichem, jointly and severally, in respect of the infringement of Article 101 TFEU.

**The procedure before the General Court and the judgment under appeal**

31      By document lodged at the Registry of the General Court on 22 September 2014, Niche brought an action seeking the annulment of the decision at issue and the cancellation of or a reduction of the fine imposed on it by that decision.

32      In its action at first instance, Niche invoked 11 pleas in law in support of the forms of order sought, the first, third, fourth, sixth, seventh and ninth of which are relevant for the purposes of this appeal. Those pleas concerned the applicability of Article 101(1) TFEU (first plea), the concept of a restriction of competition by object within the meaning of that provision (third and fourth pleas), the exemption criteria under Article 101(3) TFEU (sixth plea), respect for the rights of the defence and for the principle of sound administration (seventh plea) and, lastly, the principle of proportionality (ninth plea).

33      By the judgment under appeal, the General Court dismissed Niche’s action in its entirety.

**The procedure before the Court of Justice and the forms of order sought**

34      By document lodged at the Registry of the Court of Justice on 22 February 2019, Niche brought the present appeal.

35      By document lodged at the Registry of the Court on 5 June 2019, the United Kingdom of Great Britain and Northern Ireland sought leave to intervene in the present case in support of the form of order sought by the Commission. By decision of 1 July 2019, the President of the Court of Justice granted that application.

36      By letter of 16 September 2019, the United Kingdom waived its right to lodge a statement in intervention.

37      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). Niche and the Commission complied with that request within the prescribed period.

38      By its appeal, Niche claims that the Court should:

–        set aside the judgment under appeal in its entirety;

–        annul the decision at issue in its entirety in so far as it relates to Niche; and

–        order the Commission to pay its own costs and Niche’s costs in connection with these proceedings and the proceedings before the General Court.

39      The Commission claims that the Court should:

–        dismiss the appeal in its entirety; and

–        order Niche to pay the costs.

**The appeal**

40      Niche relies on eight grounds in support of its appeal. The first ground alleges, in essence, an error of law in the application of the Court’s case-law on restraints on competition that are ancillary to an operation or activity not covered by the prohibition rule under Article 101(1) TFEU. The second ground alleges errors of law relating to the characterisation of the Niche agreement as a restriction of competition by object. The third ground alleges that the General Court infringed its obligation to state reasons for its judgments. The fourth ground alleges errors of law relating to the concept of potential competition. The fifth ground alleges a breach of the principle of equal treatment. The sixth ground alleges an infringement of Article 101(3) TFEU. The seventh ground alleges breach of the rights of defence and of the principle of sound administration. The eighth ground alleges a breach of the principle of proportionality in relation to the fine imposed on Niche.

41      Since the application of Article 101(1) TFEU presupposes, inter alia, coordination between undertakings that are in competition with each other, if not in reality, then at least potentially (see, to that effect, judgment of 30 January 2020, *Generics (UK) and Others*, C‑307/18, EU:C:2020:52, paragraph 32), it is appropriate to examine in the first place the fourth ground, relating to the General Court’s assessment of the potential competition exerted by Niche in relation to Servier.

***The fourth ground of appeal, relating to potential competition***

*Arguments of the parties*

42      By its fourth ground of appeal, which is divided into three parts, Niche criticises the General Court’s finding that Niche was a potential competitor of Servier.

43      By the first part, Niche asserts that, by holding in paragraphs 128 and 130 of the judgment under appeal that, in the absence of a final decision finding Niche’s perindopril to be infringing, Servier’s patents could not constitute insurmountable barriers to its market entry, the General Court committed an error of law affecting the assessment of whether there was a potential competitive relationship with Servier. According to Niche, a patent can constitute a legal barrier to market entry even where there is no such decision. The fact that the manufacturer of a generic medicine may be able to enter the market by running the risk of being the subject of infringement actions by the manufacturer of the originator medicine is not, in its view, sufficient to establish that there is a potential competitive relationship between those undertakings.

44      By the second part, Niche submits that, in paragraphs 111 to 183 of the judgment under appeal, the General Court erred in law by examining separately each of the barriers with which Niche was confronted. The case-law of the EU Courts requires the General Court to evaluate the cumulative effect of those barriers on the possibilities for market access, and it should consequently have been led, in the present case, to find that in the light of the evidence in the file there was an insurmountable barrier to Niche’s entry to the perindopril market.

45      By the third part, Niche alleges that the General Court made a manifest error of assessment when applying the legal test for potential competition. It relies on two complaints in that respect.

46      First, according to Niche, in paragraph 175 of the judgment under appeal the General Court wrongly denied the probative value of notes made by a Unichem director relating to the assessment of the financial obstacles encountered by Niche. The General Court thereby committed a manifest error of assessment and disregarded the rules relating to the production of evidence.

47      Second, according to Niche, the General Court distorted the facts that demonstrated that Niche was facing insurmountable barriers.

48      In paragraph 138 of the judgment under appeal, the General Court failed to take into account the fact that, in the context of the infringement action brought by Servier in the United Kingdom, its counterclaim had been dismissed.

49      Moreover, in paragraph 161 of that judgment, the General Court relied on the fact that one of Niche’s business partners had obtained a marketing authorisation for Niche’s perindopril in the Netherlands. However, according to Niche, that authorisation could not be used for the generic version of perindopril composed of the active ingredient manufactured by Matrix. Consequently, the General Court erred when it found that the authorisation in question proved that Niche could enter the market. Those distortions related to essential elements of Niche’s arguments to the effect that it was not a potential competitor of Servier.

50      The Commission submits that the fourth ground of appeal is inadmissible in part. Since Niche did not specifically invoke the cumulative effect of the barriers encountered, before the General Court, the second part is inadmissible. Moreover, the third part is seeking to ask the Court of Justice to re-examine the facts and evidence and is, therefore, also inadmissible. The Commission submits that the fourth ground is, in any event, unfounded.

*Findings of the Court*

–       *The first part*

51      In order to respond to Niche’s line of argument to the effect that the General Court erred in law by finding that the Commission had been able to establish that Niche was a potential competitor of Servier, it should be recalled that, in the specific context of the opening of the market for a medicinal product to the manufacturers of generic medicines, it is necessary to determine, in order to assess whether one of those manufacturers, although absent from a market, is a potential competitor of a manufacturer of originator medicines present in that market, whether there are real and concrete possibilities of the former moving into that market and competing with the latter (see, to that effect, judgment of 30 January 2020, *Generics (UK) and Others*, C‑307/18, EU:C:2020:52, paragraph 36 and the case-law cited).

52      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).

53      In that regard, 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 originator medicines concerned (judgment of 30 January 2020, *Generics (UK) and Others*, C‑307/18, EU:C:2020:52, paragraph 46).

54      Admittedly, where the validity of such a patent has been definitively established before all the courts before which that question has been brought, it would hardly be conceivable that other aspects of the economic and legal context characterising objectively the competitive relationships between the holder of that patent and a manufacturer of generic medicines could justify the conclusion that there was still a potential competitive relationship between them. However, it is nevertheless for the administrative authority or the competent court to examine all the relevant elements before reaching the conclusion that that holder and that manufacturer are not potential competitors, especially where disputes between them on the question of the validity of the patent in question are still pending.

55      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).

56      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).

57      In the present case, the General Court held, in essence, in paragraphs 73 to 75 of the judgment under appeal, that a potential competitor is one which has real and concrete possibilities of entering the market in question. Such a finding must, according to that court, be based fundamentally on the ability to enter that market, supported, where applicable, by the intention to do so, while furthermore, if a market is characterised by barriers to entry, an examination of whether those barriers are insurmountable is a useful adjunct to the examination of whether there are real and concrete possibilities, based on its ability and intention, of the undertaking in question entering that market.

58      In paragraphs 76 to 80 of the judgment under appeal, the General Court stated that the evidence of potential competition can be reinforced 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 arriving on that market. It noted, in that respect, referring to its own case-law, that the conclusion of an agreement between those undertakings can constitute evidence of that perception capable of supporting the existence of potential competition.

59      It held, furthermore, in paragraphs 82 to 86 of that judgment, that, for an undertaking to be characterised as a potential competitor, it must be able to make its market entry sufficiently quickly to constitute a constraint on the undertakings present on that market and thus exert competitive pressure on them.

60      It is clear from those considerations that the General Court committed no error of law and ruled in accordance with what has been stated in paragraphs 51 to 56 of the present judgment when it set out the criteria from which it can be concluded that there is a potential competitive relationship between a manufacturer of originator medicines and a manufacturer of generic medicines. The criteria adopted by the General Court in fact correspond, in essence, to those adopted 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).

61      Niche nevertheless asserts that the General Court erred in law by finding, in essence, in paragraphs 128 and 130 of the judgment under appeal, that, in the absence of a final judicial decision finding there to be an infringement, the existence of a valid patent does not prevent potential competition from being exerted.

62      It should be noted, in that respect, that the General Court, after examining, in paragraphs 101 to 110 of the judgment under appeal, the steps taken by Niche together with its partner Matrix with a view to entering the perindopril market, in paragraphs 117 to 127 of that judgment took into consideration the potential barriers to such an entry which arose, according to Niche, from the existence of Servier’s patents. In paragraph 128 of that judgment, the General Court inferred that it ‘follows from all the foregoing that the Commission did not err in finding that, in the present case, Servier’s patents were not insurmountable barriers to the market entry of the generic companies’. Next, it observed that, ‘at the time the agreements at issue were concluded, no final decision on the merits of an infringement action had found that the products of those companies, including those of [Niche], were infringing’. In paragraph 130 of that judgment, the General Court reiterated that assessment, rejecting Niche’s arguments to the contrary based on the General Court’s case-law.

63      Accordingly, in contrast to what Niche is claiming, the General Court did not hold that a patent the validity of which– and, as the case may be, infringement by the marketing of another undertaking’s product – have not been determined by a final judicial decision can never be taken into account as a barrier to that undertaking’s entry to a market, but rather, after analysing all the considerations referred to in paragraphs 121 to 140 of the judgment under appeal, it held that the Commission had not erred by finding that Servier’s patents did not in the present case constitute insurmountable barriers to Niche’s market entry. The General Court therefore ruled in accordance with the case-law referred to in paragraphs 52 to 55 of the present judgment. It follows that paragraphs 120 and 130 of the judgment under appeal are not vitiated by the error of law alleged by Niche.

64      Accordingly, the first part of the fourth ground of appeal must be rejected.

–       *The second part*

65      In relation to the plea of inadmissibility raised by the Commission, to the effect that the line of argument developed by Niche under the second part of the fourth ground of appeal is inadmissible because it was not raised at first instance, it should be recalled that, according to Article 170 of the Rules of Procedure of the Court of Justice, an appeal cannot change the subject matter of the proceedings before the General Court. The Court’s jurisdiction in an appeal is confined to a review of the findings of law on the pleas argued before the General Court. A party cannot therefore put forward for the first time before the Court of Justice a plea in law which it has not raised before the General Court, since that would amount to allowing that party to bring before the Court of Justice, whose jurisdiction in appeals is limited, a case of wider ambit than that which came before the General Court (judgment of 25 March 2021, *Slovak Telekom* v *Commission*, C‑165/19 P, EU:C:2021:239, paragraphs 98 and 99 and the case-law cited).

66      However, an appellant is entitled to lodge an appeal relying, before the Court of Justice, on grounds which arise from the judgment under appeal itself and seek to criticise, in law, its correctness (judgment of 16 March 2023, *American Airlines* v *Commission*, C‑127/21 P, EU:C:2023:209, paragraph 143 and the case-law cited).

67      By asserting that the General Court erred in law by failing to take into consideration the cumulative effect of all the barriers that Niche alleged were insurmountable, Niche is not changing the subject matter of the proceedings before the General Court, but is criticising the grounds of the judgment under appeal.

68      Consequently, the second part of the fourth ground of appeal is admissible.

69      On the substance, it must be borne in mind that, in EU law, the prevailing principle is that evidence may be freely adduced and that the only criterion for the purpose of assessing the evidence adduced is its credibility (judgments of 25 January 2007, *Dalmine* v *Commission*, C‑407/04 P, EU:C:2007:53, paragraphs 49 and 63, and of 27 April 2017, *FSL and Others* v *Commission*, C‑469/15 P, EU:C:2017:308, paragraph 38).

70      In order to satisfy the burden of proof incumbent on it, the Commission must gather sufficiently serious, precise and consistent evidence to support the firm conviction that the alleged infringement took place (see, to that effect, judgments of 28 March 1984, *Compagnie royale asturienne des mines and Rheinzink* v *Commission*, 29/83 and 30/83, EU:C:1984:130, paragraph 20, and of 25 January 2007, *Sumitomo Metal Industries and Nippon Steel* v *Commission*, C‑403/04 P and C‑405/04 P, EU:C:2007:52, paragraphs 42 and 45).

71      However, it is not necessary for every item of evidence produced by the Commission to satisfy those criteria in relation to every aspect of the infringement. It is sufficient if the body of evidence relied on by the institution, viewed as a whole, meets that requirement (see, to that effect, judgments of 15 October 2002, *Limburgse Vinyl Maatschappij and Others* v *Commission*, C‑238/99 P, C‑244/99 P, C‑245/99 P, C‑247/99 P, C‑250/99 P to C‑252/99 P and C‑254/99 P, EU:C:2002:582, paragraphs 513 to 523, and of 14 May 2020, *NKT Verwaltungs and NKT* v *Commission*, C‑607/18 P, EU:C:2020:385, paragraph 180).

72      Furthermore, according to the Court’s case-law, 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).

73      Where the Court still has a doubt, the benefit of that doubt must be given to the undertaking to which the decision finding an infringement was addressed, having regard to the presumption of innocence which applies to procedures relating to infringements of the 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).

74      It is clear from the foregoing that, if the Commission succeeds in establishing, on the basis of a body of consistent evidence and without disregarding any barriers to market entry of which it is aware, the existence of potential competition exerted by a manufacturer of generic medicines on a manufacturer of originator medicines, 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, on that latter point, judgment of 21 January 2016, *Galp Energía España and Others* v *Commission*, C‑603/13 P, EU:C:2016:38, paragraph 72).

75      In the present case, the General Court explained, in paragraphs 101 to 109 of the judgment under appeal, that it could be found, on the basis of the evidence gathered by the Commission and referred to in the decision at issue, that Niche was a potential competitor of Servier. Consequently, it held, in paragraph 110 of that judgment, that it was necessary to determine whether Niche’s arguments concerning the patent-related and technical, regulatory, financial and commercial barriers were capable of calling into question its ability to enter the market and its intention to do so. The General Court carried out such an examination, in a detailed and comprehensive manner, in paragraphs 111 to 186 of that judgment. On the basis of its examination and on conclusion of an assessment of the facts and evidence put before it, in paragraph 187 of the judgment under appeal the General Court rejected the arguments by means of which Niche was disputing that it had the ability and the intention to enter the market.

76      In making that ruling, first, the General Court found, without erring in law, that it was for Niche to challenge the elements on the basis of which the Commission had been able to find that there was a potential competitive relationship between Niche and Servier, by submitting evidence to the contrary.

77      Second, the General Court did not err in law by examining the alleged barriers to Niche’s market entry one by one, without also verifying whether, notwithstanding the fact that none of those barriers was in itself insurmountable, their cumulative effect nevertheless gave rise to an insurmountable barrier. Such an examination is not, theoretically, necessary, and Niche has moreover not set out, either before the General Court or on appeal, what should have constituted the examination of the evidence that it criticises the General Court for failing to carry out in that respect.

78      It follows that the second part of the fourth ground of appeal must be rejected.

–       *The third part*

79      As regards the admissibility of the third part of the fourth ground of appeal, it should 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).

80      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 of 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).

81      Complaints based on findings of fact and on the assessment of those facts in the contested decision are admissible on appeal where it is claimed that the General Court has made findings which the documents in the file show to be substantially incorrect or that it has distorted the clear sense of the evidence before it (judgment of 18 January 2007, *PKK and KNK* v *Council*, C‑229/05 P, EU:C:2007:32, paragraph 35).

82      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).

83      In the present case, by its first complaint, under the guise of claiming an infringement of the rules on the production of evidence summarised in paragraphs 69 to 73 of the present judgment, Niche is in reality disputing the General Court’s factual appraisal, in paragraph 175 of the judgment under appeal, of the probative value of notes made by a director of Unichem regarding the effect on Niche’s financial situation of the costs associated with patent litigation.

84      According to the case-law referred to in paragraphs 79 to 82 of the present judgment, such reasoning does not fall within the jurisdiction of the Court of Justice in appeal proceedings. The Commission’s plea of inadmissibility must therefore be upheld and the third part of the fourth ground of appeal must be rejected.

85      Furthermore, by its second complaint, Niche alleges that the General Court distorted the facts, first, because when it relied, in paragraph 138 of the judgment under appeal, on the fact that on 9 July 2004 in infringement proceedings relating to the 339, 340 and 341 patents, Niche had served Servier with a counterclaim seeking a declaration of invalidity in respect of the 947 patent, that court did not mention that the counterclaim in question had been rejected by the United Kingdom court with jurisdiction on 28 July 2004. It is, in reality, apparent from the evidence that Niche produced before the General Court that the claim in question was unsuccessful, with the effect that paragraph 138 of the judgment under appeal distorts the fact relating to Niche’s submission of that counterclaim, by omitting to mention another circumstance, that is to say, that that claim was rejected shortly after it was served, which significantly diminishes its importance.

86      It should nevertheless be noted that, in the same sentence of paragraph 138 of the judgment under appeal, the General Court also refers to an opposition against the 947 patent that Niche brought before the EPO subsequently, in November 2004. The General Court was relying on both those circumstances in the next part of its reasoning when it found, at the end of that paragraph 138, that it could not be inferred from the allegations and documents put forward by Niche that it did not intend to enter the market because the risks of infringing Servier’s 947 patent were too high. In those circumstances, and also having regard to the case-law referred to in paragraph 53 of the present judgment, and to all the circumstances relating to the steps taken by Niche with a view to entering the perindopril market that were analysed by the General Court, in particular in paragraphs 117 to 127 of the judgment under appeal, it must be held that the complaint relating to the distortion found in the preceding paragraph concerns an aspect included only for the sake of completeness and cannot therefore undermine the conclusion reached by the General Court in paragraph 138 of the judgment under appeal or, therefore, lead to the third part of the fourth ground of appeal being upheld, since it is ineffective.

87      Second, Niche alleges that there is a distortion in paragraph 161 of the judgment under appeal, since the General Court mentioned ‘the success of one of its partners which obtained a marketing authorisation for its product in the Netherlands in the same period’ in order to prove that Niche’s market entry was possible, even though that authorisation did not concern an identical form of perindopril. It is sufficient, however, to note that that reference, in addition to the fact that it merely reinforces a finding based on other circumstances also set out in paragraph 161 of the judgment under appeal, does not specify which version of perindopril was covered by the authorisation obtained in the Netherlands, and the General Court therefore did not distort that fact.

88      In the light of the foregoing, the fourth ground of appeal is rejected.

***The second ground of appeal, relating to characterisation as a restriction of competition by object***

*Arguments of the parties*

89      By its second ground of appeal, which is divided into two parts, Niche asserts that the General Court erred in law by holding that the Commission was entitled to characterise the Niche agreement as a restriction of competition by object within the meaning of Article 101(1) TFEU.

90      By the first part of its second ground of appeal, Niche submits that the General Court ruled on the characterisation as a restriction of competition by object on the basis of incorrect legal criteria. It recalls that the concept in question must be interpreted strictly, in the light of the wording and objective of the agreement in question and its economic and legal context, the essential criterion being whether the coordination between undertakings reveals, in itself, a sufficient degree of harm to the proper functioning of normal competition. According to Niche, the General Court disregarded those factors.

91      In the first place, Niche submits that the General Court failed to take into account the relevant factual context in the light of the wording and purpose of the Niche agreement.

92      The General Court stated, in paragraph 256 of the judgment under appeal, that non-marketing and non-challenge clauses ‘are, by themselves, restrictive of competition’. According to Niche, in addition to the fact that that statement contradicts the statement in paragraph 315 of that judgment, according to which those clauses ‘are … inherent in some settlement agreements’, it also disregards the fact that the Niche agreement enabled that company, from 2008, to enter the perindopril market with no risk of being subject to infringement actions in respect of the EP1294689, 947 and 948 patents. The General Court distorted its legal arguments in that respect, with the effect that the findings in paragraph 303 of the judgment under appeal are incorrect and cannot serve as the basis for holding that the restrictions accepted by Niche were inherently anticompetitive.

93      In the second place, Niche submits that the General Court did not take the relevant economic and legal context into account.

94      According to Niche, on the date on which an agreement is concluded to settle disputes relating to a patent, the Commission cannot know whether that patent is valid or whether it has been infringed, or whether the parties to that agreement are potential competitors or whether the agreement in question merely reflects the rights protected by that patent. The Commission cannot find any such agreement to be, inherently, anticompetitive. The uncertainty as regards the validity of that patent or whether it has been infringed necessarily prevents an agreement of that kind, containing non-challenge and non-marketing clauses, from being found to be, inherently, injurious to competition.

95      The General Court considered, in paragraph 286 of the judgment under appeal, that the fact that the holder of a patent induces a manufacturer of generic medicines to conclude a settlement agreement by means of a transfer of value to that manufacturer constitutes abnormal use of that patent. However, in Niche’s view, such a transfer of value constitutes neither a restriction of competition nor abnormal use of a patent, but is, rather, common practice in European patent litigation.

96      By the second part of its second ground of appeal, Niche claims that a transfer of value cannot, in itself, constitute a decisive factor for the purposes of characterising an agreement as a restriction of competition by object.

97      First of all, Niche believes such a criterion to be ineffective, because it does not make it possible to distinguish between harmless restrictions and those that are inherently injurious to competition.

98      Next, Niche asserts that that criterion is too broad. When it held, in paragraphs 292 and 293 of the judgment under appeal, that only the costs inherent in the settlement of disputes – such as those covering litigation expenses – can be regarded as being justified, the General Court interpreted the concept of a restriction of competition by object too broadly. The existence of a reverse payment cannot, in itself, be regarded as unlawful, in the light of the recognised importance of settlement agreements, of the risks associated with launching a generic medicine and of the cost, uncertainties and complexity of litigation.

99      Lastly, when it held, in paragraph 294 of the judgment under appeal, that it is for undertakings to demonstrate that a reverse payment covers costs inherent in the dispute settlement or that the payment in question is insufficient to induce a manufacturer of generic medicines to settle, the General Court reversed the burden of proving the elements of the infringement, which lies with the Commission.

100    The Commission claims that the second ground of appeal is unfounded.

*Findings of the Court*

101    Under its second ground of appeal, Niche puts forward a complaint criticising the General Court for ruling on the characterisation of the Niche agreement as a restriction of competition by object on the basis of a misinterpretation and a distortion of the provisions of that agreement. The arguments put forward by Niche in that respect overlap with those set out in greater detail in the second part of its first ground of appeal. It will therefore be appropriate to examine all the arguments relating to the interpretation and distortion of that agreement as part of the appraisal of the second part of the first ground of appeal.

102    As to the remainder, the line of argument developed in the second ground of appeal seeks in essence to assert that whether or not a patent dispute settlement agreement constitutes a restriction of competition by object should not depend on the existence of a reverse payment, that is to say, on a transfer of value from the manufacturer of originator medicines to the manufacturer of generic medicines. According to Niche, that test has the effect of overly broadening the scope of that concept and of reversing the burden of proving the infringement.

103    As part of that line of argument, referring to paragraph 256 of the judgment under appeal, Niche disputes that the object of the non-challenge and non-marketing clauses contained in the Niche agreement is anticompetitive.

104    It can in fact be seen from paragraph 256 of that judgment that the General Court found that such clauses ‘are, by themselves, restrictive of competition’. The General Court noted in that regard, in particular, that non-challenge clauses undermine the public interest in eliminating any obstacle to economic activity which may arise where a patent was granted in error, and that non-marketing clauses entail the exclusion from the market of one of the patent holder’s competitors.

105    The Court of Justice has already held that challenges to the validity and scope of a patent are part of normal competition in the sectors where there exist exclusive rights in relation to technology, so that settlement agreements whereby a manufacturer of generic medicines that is seeking to enter a market recognises, at least temporarily, the validity of a patent held by a manufacturer of originator medicines and gives an undertaking, as a result, not to challenge that patent and not 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).

106    Admittedly, an agreement to settle a patent dispute may be concluded, with a legitimate aim and entirely lawfully, on the basis of the parties’ recognition of the validity of the patent in question, in the absence of any other circumstance constituting an infringement of Article 101 TFEU. Such an agreement can even include non-challenge and non-marketing clauses, the scope of which is limited to that of the patent in question, as the General Court held in paragraphs 257 and 262 of the judgment under appeal. Nevertheless, as can be seen from the next part of the General Court’s reasoning, in particular from paragraphs 258 to 275 of the judgment under appeal, characterisation of such an agreement as a restriction of competition by object also depends on other characteristics of that agreement and on the circumstances in which it was concluded, as a result of which the agreement can, if applicable, be regarded as revealing a sufficient degree of harm to competition.

107    It must therefore be found, subject to examination of all the complaints alleging that the Niche agreement was distorted, which will be examined under the third ground of appeal, that the General Court did not err in law when it held, in paragraphs 255 to 263 of the judgment under appeal, in particular in paragraph 256 of that judgment, that the non-challenge and non-marketing clauses contained in the Niche agreement could constitute restrictions of competition by object, on the basis of their characteristics and the circumstances in question as a whole.

108    As regards the criticism levelled against the criteria that the General Court used to characterise an agreement between undertakings as a restriction of competition by object, it must be found that, as the General Court held, in essence, in paragraphs 263 and 264 of the judgment under appeal, the presence of non-challenge and non-marketing clauses may give rise to characterisation of the agreement as a restriction of competition by object where it is apparent that the manufacturer of generic medicines does not agree to those clauses on the basis of its recognition of the validity of the patent held by the manufacturer of originator medicines, but on the basis of a payment to it by the latter. The test for determining whether a settlement agreement such as the Niche agreement constitutes a restriction of competition by object is whether the ‘reverse’ transfers of value from the manufacturer of originator medicines to the manufacturer of generic medicines constitute the real consideration for the latter refraining from entering 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).

109    It should be noted in that respect that, if it is to be subject to the prohibition in principle laid down in Article 101(1) TFEU, a collusive practice must have as its ‘object or effect’ the prevention, restriction or distortion to an appreciable extent of competition within the internal market. 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, paragraphs 62 and 63).

110    Accordingly, as regards practices characterised as restrictions of competition by object, there is no need to investigate nor, a fortiori, to demonstrate, their effects on competition, in so far as experience shows that such behaviour leads to falls in production and price increases, resulting in poor allocation of resources to the detriment, in particular, of consumers (see, to that effect, judgments of 19 March 2015, *Dole Food and Dole Fresh Fruit Europe* v *Commission*, C‑286/13 P, EU:C:2015:184, paragraph 115, and of 21 December 2023, *European Superleague Company*, C‑333/21, EU:C:2023:1011, paragraph 159).

111    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).

112    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).

113    As Niche asserts, the concept of a 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).

114    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).

115    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).

116    Accordingly, the assessment of the degree of economic harm of an agreement to the proper functioning of competition in the market concerned must be based on objective considerations, where necessary as a result of a detailed analysis of the agreement at issue, 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).

117    In that context, it should also be noted that 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 concerned and to conclude with the latter an agreement in settlement of those proceedings. As noted in paragraph 106 of the present judgment, such an agreement cannot in all cases be regarded as 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 the originator medicine to a manufacturer of generic medicines is not sufficient ground to classify 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 that correspond in fact to compensation for the costs of or disruption caused by the litigation between them, or that 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).

118    Consequently, wherever an agreement to settle a dispute relating to the validity of a patent, between a manufacturer of generic medicines and a manufacturer of originator medicines that holds that patent, involves transfers of value from the manufacturer of originator medicines to the manufacturer of generic medicines, it is necessary to determine, at the first stage, whether the net gain arising from those transfers 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 (see, to that effect, judgment of 30 January 2020, *Generics (UK) and Others*, C‑307/18, EU:C:2020:52, paragraph 92).

119    The settlement of such a dispute implies that the manufacturer of generic medicines recognises the validity of the patent in question, because it waives the 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.

120    At the second stage, 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 examination it is necessary to determine whether that net gain, including any justified expenses, is sufficiently large actually to act as an incentive for the manufacturer of generic medicines to refrain from entering the market concerned, and there is no requirement that that net gain be necessarily greater than the profits which it 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).

121    In the present case, in paragraphs 255 to 274 of the judgment under appeal, the General Court held that the presence in a patent dispute settlement agreement of competition-restricting clauses such as non-challenge and non-marketing clauses, where it is associated with a reverse payment, can be characterised as a restriction of competition by object 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.

122    In paragraphs 291 to 294 of that judgment, 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 intended to compensate for the costs inherent in the settlement that were borne by the manufacturer of generic medicines. The General Court clarified that those costs include, in particular, the expenses borne in the context of the proceedings to which the settlement agreement relates, provided those expenses have been established by the parties to that agreement and are not disproportionate to the amount of the expenses objectively indispensable to the litigation. By contrast, according to the judgment under appeal, the costs inherent in the settlement do not include the value of the stock of infringing medicines or the research and development costs incurred in developing those medicines. According to that judgment, 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 of contract.

123    That assessment by the General Court of the circumstances in which the ‘reverse’ payment of such expenses can be justified and that it can therefore be concluded that there has been no inducement in the form of a transfer of value corresponds, in essence, to the assessment that emerges from the case-law of the Court of Justice summarised in paragraphs 117, 118 and 120 of the present judgment, and reveals no error of law.

124    Niche nevertheless submits that, in paragraph 294 of the judgment under appeal, the General Court reversed the burden of proof to be borne by the Commission.

125    It is also apparent from paragraph 294 of the judgment under appeal that, although the reimbursement by a manufacturer of originator medicines of the litigation expenses borne by a manufacturer of generic medicines in connection with a dispute between them that has been settled may be justified by the fact that those expenses are ‘inherent’ in that settlement, provided they are not excessive and therefore disproportionate, other expenses that are too ‘extraneous’ to the dispute and to its settlement cannot, in contrast, be regarded as inherent in that dispute and its settlement. The General Court found that it is for those undertakings, if they do not wish the payment of those costs by the patent holder ‘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’.

126    As regards the reimbursement by the manufacturer of originator medicines of the value of the stock of infringing medicines, of the research and development costs incurred in developing those medicines and of any compensation that the manufacturer of generic medicines might possibly have to pay to third parties, as can be seen from paragraph 167 of today’s judgment in *Servier and Others* v *Commission* (C‑201/19 P), payments of that kind are the direct consequence not of the intention of the manufacturers of medicines 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 294 of the judgment under appeal by holding, in essence, that such a reimbursement cannot be regarded as being inherent in a settlement agreement such as the Niche agreement.

127    In the light of the foregoing, contrary to Niche’s line of argument, nor did the General Court reverse the burden of proof in paragraph 294 of the judgment under appeal. The General Court, in essence, merely found that where costs such as those referred to in the preceding paragraph of the present judgment have been reimbursed by the manufacturer of originator medicines, analysis of the net gain from transfers of value to the manufacturer of generic medicines must include those costs. When it stated, also in paragraph 294, 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 on the allocation of the burden of proof referred to in paragraph 72 of the present judgment.

128    In the light of the foregoing, the second ground of appeal must be rejected.

***The third ground of appeal, alleging a failure to state reasons***

*Arguments of the parties*

129    By its third ground of appeal, Niche submits that, by rejecting its interpretation of Clause 6 of the Niche agreement, in paragraph 303 of the judgment under appeal, and finding that that clause did not allow an early market entry by Niche before the 947 patent expired in 2021, the General Court infringed the obligation to state reasons for its judgments.

130    Niche submits that the General Court omitted to respond to the argument that – according to the principles of English law applicable to that agreement and in particular according to the analysis of those principles apparent from the expert report by a professor of English law produced by Niche before the General Court at the stage of the reply at first instance – the Niche agreement should have been interpreted as conferring a right on Niche to enter the perindopril market without being subject to actions for infringement of the 947 patent, as soon as the 339, 340 and 341 patents expired in 2008.

131    That argument was crucial to assessing the pleas in law at first instance relating, first, to the ‘objective necessity’ test arising from the Court’s case-law on restraints that are ancillary to legitimate agreements; second, to the concept of a restriction of competition by object; and, third, to the conditions for the exemption under Article 101(3) TFEU to apply.

132    The Commission disputes those arguments.

*Findings of the Court*

133    According to the settled case-law of the Court of Justice, the statement of the reasons on which a judgment is based must clearly and unequivocally disclose the General Court’s thinking, so that the persons concerned can be apprised of the justification for the decision taken and the Court of Justice can exercise its power of review (judgment of 9 March 2023, *Les Mousquetaires and ITM Entreprises* v *Commission*, C‑682/20 P, EU:C:2023:170, paragraph 40 and the case-law cited).

134    Furthermore, it can be seen from that case-law that the General Court’s duty to state reasons does not require it 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 General Court’s reasoning may therefore be implicit, on condition that it enables the persons concerned to know why it has not upheld their arguments and provides the Court of Justice with sufficient material for it to exercise its power of review (judgment of 11 May 2017, *Dyson*  v *Commission*, C‑44/16 P, EU:C:2017:357, paragraph 38 and the case-law cited).

135    In the present case, it should be noted at the outset that Niche’s assertion as to the correct interpretation of the Niche agreement would mean, in essence, that Clause 6 of that agreement, albeit without explicitly so stating, gave rise to Niche being granted a licence to exploit the 947 patent, with no specific consideration in return, from 2008. The General Court, in paragraph 303 of the judgment under appeal, concluded from a combined reading of Clauses 3, 5 and 6 of the Niche agreement that the Commission had, correctly, found that Clause 6 of that agreement did not allow an early market entry by Niche before expiry of the 947 patent, contrary to what Niche was claiming.

136    The reasoning that the General Court followed in paragraph 303 of the judgment under appeal is, in itself, clear, understandable and such as to state adequate reasons for the conclusion it is intended to support.

137    Having regard to the circumstances described above, and in particular in the absence of explanations by Niche lending credibility to its assertion that, contrary to the interpretation of the terms of the Niche agreement put forward by the Commission, Clause 6 of that agreement authorised Niche’s early entry to the perindopril markets before expiry of the 947 patent, with no specific consideration in return, Niche’s arguments at first instance did not require a specific response from the General Court to the matters contained in expert opinions, including in the opinion of a professor of English law invoked before it by Niche.

138    The third ground of appeal must therefore be rejected as unfounded.

***The first ground of appeal, relating to ancillary restraints***

*Arguments of the parties*

139    By its first ground of appeal, Niche submits that, in paragraphs 315 to 319 of the judgment under appeal, the General Court made errors of law in applying the case-law of the Court of Justice on restrictions of competition ancillary to legitimate agreements. Niche asserts, in essence, that the General Court wrongly held that the fact that a manufacturer of originator medicines, by means of a reverse payment, induced a manufacturer of generic medicines to conclude an agreement to settle patent disputes which contained non-challenge and non-marketing clauses means that those clauses can be found not to be ‘objectively necessary’ in order to settle disputes. That first ground is divided into two parts.

140    By the first part, Niche submits that the application of the ‘objective necessity’ test for an ancillary restraint does not involve carrying out an examination of the economic terms of a settlement agreement. The existence of a reverse payment does not, in its view, mean that an ancillary restriction of competition that is necessary and proportionate can be characterised as a restriction of competition by object.

141    The General Court’s assertion, in paragraph 318 of the judgment under appeal, that the Niche agreement is not a genuine patent settlement agreement but a market exclusion agreement, is based on a mistaken analogy with the judgment of 20 November 2008, *Beef Industry Development Society and Barry Brothers* (C‑209/07, EU:C:2008:643), which concerned a situation in which the agreement at issue did not relate to intellectual property rights and did not pursue any legitimate objective.

142    Furthermore, according to Niche, the General Court erred in law by holding, in paragraph 319 of the judgment under appeal, that inducing a competitor to accept a restriction of competition is neither normal nor objectively necessary for the protection arising from a patent. That statement is not based on any case-law precedent and disregards the fact that it is standard practice for a patent holder to end a dispute and protect itself against the market entry of a third party by means of a payment.

143    In that context, Niche submits that it was for the Commission to demonstrate that a transfer of value masked unlawful horizontal coordination. In the present case, the General Court acknowledged that there was no fraud and that the dispute was legitimate, and refrained from ruling on the validity or infringement of the 947 patent. The General Court should not have allowed the Commission merely to invoke a transfer of value in order to establish an infringement.

144    By the second part, Niche submits that the General Court misinterpreted the Niche agreement. Application of the ‘objective necessity’ test should have led the General Court to hold that the non-challenge and non-marketing clauses in that agreement were necessary and proportionate to the settlement of the disputes relating to Servier’s patents. Niche notes, in that respect, that the agreement in question preserved first, Niche’s right to ‘launch at risk’ a generic version of perindopril; second, its right to enter the market as of 2008, that is to say, 13 years before expiry of the 947 patent; and, third, its right to retain the marketing authorisations and to place customer relationships on hold so that there could be a ‘prompt resurrection’ in 2008.

145    Niche asserts that, in paragraph 303 of the judgment under appeal, the General Court rejected that interpretation of the Niche agreement by manifestly distorting the arguments set out in its pleadings at first instance.

146    First of all, the General Court’s statement that Niche ‘does not dispute that Clause 3 of the [Niche agreement] prohibit[ed it] from manufacturing and marketing the perindopril that it had developed with Matrix’ is incorrect. That Clause 3 related only to the perindopril manufactured using the Matrix process or a substantially similar process.

147    Next, Niche denies that it accepted that Clause 6 of the Niche agreement was intended solely to clarify the expiry date of the non-marketing obligation under Clause 3 of that agreement. On the contrary, Niche claimed that the purpose of that Clause 6 was to enable it to enter the market as from 2008, with no fear of being subject to actions for infringement of Servier’s patents.

148    Lastly, Niche denies that it acknowledged that Clause 6 of that agreement was ‘intended to prevent … a situation in which the generic companies would be able to market their product immediately after [the] expiry’ of the 339, 340 and 341 patents. In reality, since, in order to enter the market as soon as possible, there would be a temptation to begin production before those patents expired, that Clause 6 was intended to ensure that only perindopril manufactured after that date could be marketed.

149    The Commission disputes those arguments. The first part of the first ground of appeal is, in its view, unfounded. According to the Commission, the second part of that ground of appeal is inadmissible, because Niche is seeking a re-assessment by the Court of Justice of the facts and evidence relating, inter alia, to whether the Niche agreement enabled Niche’s early market entry.

*Findings of the Court*

–       *The first part*

150    Niche submits that the General Court misapplied the rules relating to restrictions of competition ancillary to legitimate agreements.

151    It should be recalled 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 the sense 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).

152    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).

153    In the present case, the General Court found, in paragraph 316 of the judgment under appeal, that, where the real reason for a settlement agreement is not the parties’ recognition of the validity of the patent but a wish to ‘induce’ the manufacturer of generic medicines to agree to non-marketing and non-challenge clauses, ‘the restrictions on competition introduced by [those clauses] cannot … be regarded as objectively necessary and thus as ancillary to the settlement’.

154    In paragraphs 318 and 319 of the judgment under appeal, the General Court stated that ‘as a result … of the inducement for the generic company to accept [non-challenge and non-marketing clauses], the agreements at issue are market exclusion agreements … and not genuine settlement agreements, thus precluding a finding in the present case of a neutral or positive operation as regards competition’. In paragraph 319 of that judgment, the General Court noted in that respect that ‘inducing a competitor to accept [such] clauses is an abnormal use of the patent …, which is not covered by the specific subject matter of [that] patent and, thus, not objectively necessary for its protection’. In paragraph 320 of that judgment, the General Court concluded from those considerations that the Commission had been entitled not to apply the case-law of the Court of Justice on restraints that are ancillary to legitimate agreements.

155    The General Court thus correctly applied the case-law of the Court of Justice referred to in paragraphs 151 and 152 of the present judgment. Furthermore, Niche’s argument claiming that reverse payments such as the payment it received from Servier are common cannot succeed since it does not in any respect call into question the fact that the payment in question was anticompetitive in the light of that case-law.

156    The first part of the first ground of appeal must therefore be rejected.

–       *The second part*

157    By a first argument, Niche submits that the General Court misinterpreted the provisions of the Niche agreement. However, the interpretation of a term of a contract by the General Court constitutes a question of fact which, unless there is distortion, cannot be subject, as such, to review by the Court of Justice in the context of an appeal (judgment of 16 November 2017, *Ludwig-Bölkow-Systemtechnik* v *Commission*, C‑250/16 P, EU:C:2017:871, paragraph 49 and the case-law cited). Since Niche has not claimed a distortion of that agreement, that first argument must therefore be rejected as inadmissible.

158    Niche’s second argument is that, in paragraph 303 of the judgment under appeal, the General Court distorted the terms of its pleadings at first instance and, therefore, wrongly rejected its interpretation of the provisions of the Niche agreement.

159    In that respect, as noted in paragraph 81 of the present judgment, complaints based on findings of fact and on the assessment of those facts in the contested decision are admissible on appeal where it is claimed that the General Court has made findings which the documents in the file show to be substantially incorrect or that it has distorted the clear sense of the evidence before it (judgment of 18 January 2007, *PKK and KNK* v *Council*, C‑229/05 P, EU:C:2007:32, paragraph 35).

160    It follows that, contrary to the Commission’s assertion, the complaints of distortion that Niche alleges are not, in their entirety, inadmissible.

161    On the substance, as noted in paragraph 82 of the present judgment, a 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).

162    It is clear that, in the present case, none of the three distortions of the pleadings at first instance alleged by Niche satisfies those criteria.

163    Niche states that it asserted, before the General Court, that Clause 3 of the Niche agreement did not prevent it from producing and marketing a non-infringing generic version of perindopril that was not manufactured on the basis of the Matrix process.

164    It is apparent from reading the passage of the application at first instance that it claims has been distorted that Niche was claiming that Clause 3 of the Niche agreement – which, according to Niche, concerned only perindopril ‘manufactured using the disputed Matrix process or a substantially similar process’ – did not go beyond the scope of those patents and did not prevent it from marketing a generic version of perindopril composed of an active ingredient other than the alpha crystalline form of erbumine.

165    It must therefore be found that the assertion, in paragraph 303 of the judgment under appeal, that Niche ‘does not dispute that Clause 3 of the [Niche agreement] prohibited it from manufacturing and marketing the perindopril that it had developed with Matrix’ does not contain any manifest distortion of the terms of Niche’s application at first instance, since that application did not explain in what respect the perindopril ‘that it had developed with Matrix’ was different from that ‘manufactured using the disputed Matrix process or a substantially similar process’.

166    The second allegation of distortion consists in asserting that the General Court held, wrongly, that Niche had accepted that Clause 6 of the Niche agreement was intended only to ‘clarify the end’ of the prohibition on marketing the perindopril developed with Matrix.

167    However, that allegation is based on a misreading of the judgment under appeal. In fact, in paragraph 303 of that judgment the General Court merely set out the terms of Clause 6 of the Niche agreement, stating ‘that it follows from the very wording of [that Clause 6] that the envisaged marketing possibility was intended only to clarify the end of [the prohibition under Clause 3 of that agreement], by stipulating that [Niche] could manufacture and sell [the perindopril that it had developed with Matrix] and any perindopril falling within the scope of the [339, 340 and 341] patents after their expiry, but not that it could sell perindopril falling within the scope of the 947 patent before its expiry, without facing actions for the infringement of that patent brought by Servier’. The General Court therefore did not attribute that statement about the scope of that Clause 6 to Niche.

168    As regards the third distortion alleged by Niche, in the guise of claiming distortion of its pleadings at first instance, Niche is clearly disputing in reality the validity of the General Court’s interpretation of the Niche agreement, in particular the interpretation resulting from a combined reading of Clauses 3, 5 and 6 thereof, although without indicating in what respect the General Court distorted those clauses or the elements contained in its pleadings at first instance. On that last point, it is not clear from Niche’s appeal how the General Court distorted Niche’s pleadings at first instance by finding, in paragraph 303 of the judgment under appeal, that Niche had ‘itself recognised the utility and the commercial logic of Clause 6 of the [Niche agreement], regardless of the interpretation that it put forward in the present action’, in the sense that that clause was intended to prevent the manufacturers of generic medicines from entering each national market immediately after expiry of the 339, 340 and 341 patents. Niche asserts before the Court of Justice that Clause 6 is ‘meaningful’ because it is intended to ensure that only perindopril manufactured after expiry of those patents enjoyed protection, but not perindopril manufactured earlier in anticipation of that expiry. It appears that that explanation of the commercial objective of Clause 6 corresponds, in essence, to the General Court’s explanation set out in the present paragraph.

169    The second part of the first ground of appeal and, consequently, the complaint put forward under the second ground of appeal and referred to in paragraph 101 of the present judgment, must therefore be rejected.

170    It follows that the first ground of appeal must be rejected in its entirety.

***The fifth ground of appeal, relating to unequal treatment***

*Arguments of the parties*

171    By its fifth ground of appeal, Niche claims that it received unequal treatment compared with Krka in so far as, in relation to Niche, the General Court applied a strict test for the existence of a restriction of competition by object. In its judgment of 12 December 2018, *Krka* v *Commission* (T‑684/14, EU:T:2018:918), in contrast, the General Court examined whether the Krka agreements constituted a restriction of competition by effect, which it did not do in the judgment under appeal in relation to the Niche agreement.

172    In the first place, Niche submits that its situation was similar to that of Krka. Those undertakings were both manufacturers of generic medicines, had tried for many years to manufacture or obtain non-infringing perindopril and had ultimately concluded patent dispute settlement agreements with Servier. Both those agreements provided for a transfer of value from Servier.

173    In the second place, the fact that Niche accepted a transfer of value from Servier in the form of a payment rather than of a royalty under a licence agreement cannot amount to an objective justification for the difference in treatment compared with Krka.

174    The Commission disputes those arguments.

*Findings of the Court*

175    It should be noted that, according to the case-law referred to in paragraphs 110, 114 and 115 of the present judgment, in relation to practices characterised as restrictions of competition by object, it is not necessary to investigate nor, a fortiori, to demonstrate their effects on competition, be they actual or potential, or negative or positive.

176    In the present case, it follows from the rejection of the first, second and fourth grounds of appeal that the General Court did not err in law when, in paragraph 322 of the judgment under appeal, it rejected the plea in law at first instance alleging errors of law and of assessment allegedly committed by the Commission in relation to the characterisation of the Niche agreement as a restriction of competition by object.

177    It is clear, in particular, from recital 1407 of the decision at issue that the infringement referred to in Article 1 of that decision was based on the dual characterisation of the Niche agreement as a restriction of competition by object and by effect. Accordingly, when it held, in paragraphs 323 to 327 of the judgment under appeal, that, even if the plea in law at first instance by which Niche disputed the characterisation of the Niche agreement as a restriction of competition by effect had been well founded, that plea could not have led to annulment of the operative part of the decision at issue, the General Court merely drew the appropriate inferences from the alternative nature of the requirement laid down in Article 101(1) TFEU, relating to the existence of a restriction of competition by object or by effect, in accordance with the case-law referred to in paragraphs 109, 110, 114 and 115 of the present judgment. In those circumstances, the General Court did not commit an error of law when, in paragraph 327 of the judgment under appeal, it rejected that plea in law as ineffective.

178     In its judgment of 12 December 2018, *Krka* v *Commission* (T‑684/14, EU:T:2018:918), in contrast, the General Court, in paragraph 268, upheld Krka’s third plea in law, alleging that there was no restriction of competition by object in relation to the settlement and licence agreements and, in paragraph 298, its fourth plea, alleging that there was no restriction of competition by object in relation to the assignment agreement. In those circumstances, in the light of the alternative nature of the requirement laid down in Article 101(1) TFEU relating to the existence of a restriction of competition by object or by effect, the General Court was obliged to examine in addition, in that judgment, Krka’s fifth plea, alleging the absence of any restriction of competition by effect since, in the absence of such an examination, it would not have been in a position to rule on the validity of the Commission’s finding that Krka had infringed Article 101(1) TFEU. Accordingly, the difference between the treatment of that fifth plea in law and the treatment of Niche’s plea in law at first instance relating to the characterisation of the Niche agreement as a restriction of competition by effect can be explained by an objective difference between the situations.

179    In so far as Niche asserts that the General Court applied a stricter test for the existence of a restriction of competition by object, it is apparent, inter alia, from paragraph 276 of today’s judgment in *Commission* v *Krka* (C‑151/19 P), that errors of law made by the General Court affect the entirety of the reasoning – set out in paragraphs 179 to 268 of the judgment of the General Court of 12 December 2018, *Krka* v *Commission* (T‑684/14, EU:T:2018:918) – relating to the characterisation of the settlement and licence agreements concluded with Krka as a restriction of competition by object.

180    As the Commission’s appeal in Case C‑151/19 P was upheld, the Court of Justice set aside the judgment of 12 December 2018, *Krka* v *Commission* (T‑684/14, EU:T:2018:918), 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 rejecting, in particular, the first to third pleas in law, relating to the characterisation of the settlement and licence agreements concluded by Krka as a restriction of competition by object; the fifth plea, relating to the existence of a restriction of competition by effect; and the sixth plea, relating to Article 101(3) TFEU, of Krka’s action at first instance in Case T‑684/14. It follows that Niche is not justified in asserting a breach of the principle of equal treatment by comparison with what was held in Case T‑684/14.

181    The fifth ground of appeal must therefore be rejected.

***The sixth ground of appeal, relating to Article 101(3) TFEU***

*Arguments of the parties*

182    By its sixth ground of appeal, Niche claims that the General Court erred in law in paragraphs 356 and 357 of the judgment under appeal, by rejecting the line of argument to the effect that the Niche agreement should have enjoyed an exemption under Article 101(3) TFEU. The General Court allegedly held, contrary to Niche’s arguments to that effect, that that agreement did not allow the undertaking in question to market a version of perindopril composed of the alpha crystalline form of erbumine protected by the 947 patent without waiting for that patent to expire in 2021. That finding is based on a distortion, in paragraph 303 of the judgment under appeal, of the arguments and evidence put forward by Niche at first instance in relation to the interpretation of the Niche agreement.

183    The Commission disputes that line of argument.

*Findings of the Court*

184    The applicability of the exemption provided for in Article 101(3) TFEU is subject to the satisfaction of four cumulative requirements laid down in that provision. Those requirements are, first, that the arrangement concerned must contribute to improving the production or distribution of the goods or services in question, or to promoting technical or economic progress; second, that consumers must be allowed a fair share of the resulting benefit; third, that it must not impose on the participating undertakings restrictions that are not indispensable; and, fourth, that it must not afford them the possibility of eliminating competition in respect of a substantial part of the products or services in question (judgments of 23 January 2018, *F. Hoffmann-La Roche and Others*, C‑179/16, EU:C:2018:25, paragraph 97, and of 18 January 2024, *Lietuvos notarų rūmai and Others*, C‑128/21, EU:C:2024:49, paragraph 100).

185    In order to demonstrate that the General Court erred in applying Article 101(3) TFEU, in particular in relation to the first of the requirements laid down by that provision, Niche submits that the General Court relied on a misinterpretation and a manifest distortion of the legal arguments and the evidence relating to the Niche agreement. The sixth ground of appeal is therefore based on Niche alleging the errors of interpretation and the distortions that it alleged in relation to paragraph 303 of the judgment under appeal in the context of the second part of its first ground of appeal and in the first part of its second ground of appeal. For the reasons set out in paragraphs 157 to 169 of the present judgment, those arguments have been rejected in their entirety.

186    In so far as Niche alleges a distortion of the evidence comprising the ‘expert opinions’ submitted before the General Court, it is sufficient to note that the General Court, in setting out its own analysis of Clauses 3, 5 and 6 of the Niche agreement, did not comment on or, a fortiori, distort any expert opinions, including the opinion of a professor of English law to which Niche referred.

187    The sixth ground of appeal is therefore based on an incorrect premiss.

188    In those circumstances, it must be found that, when it held, in paragraphs 356 and 357 of the judgment under appeal, in relation to the efficiency gain claimed by Niche resulting from the fact that the Niche agreement allegedly enabled it to sell a version of perindopril covered by the 947 patent before expiry of that patent in 2021, that the agreement in question did not provide for any such possibility and that, therefore, the Commission had correctly found that the first requirement laid down in Article 101(3) TFEU was not satisfied, the General Court committed no error of law in the application of that provision.

189    Consequently, the General Court did not err in law, in paragraph 358 of the judgment under appeal, when it held, in the light of the cumulative nature of the four requirements laid down by Article 101(3) TFEU, that the Commission was entitled to decide that the Niche agreement could not enjoy an exemption under that provision.

190    It follows that the sixth ground of appeal must be rejected.

***The seventh ground of appeal, alleging breach of the rights of the defence and of the principle of sound administration***

*Arguments of the parties*

191    By its seventh ground of appeal, Niche alleges breach of the rights of the defence and of the principle of sound administration. That ground is divided into two parts.

192    By the first part, Niche claims that, in paragraphs 61 and 62 of the judgment under appeal, the General Court infringed the rights of the defence and the principle of sound administration by failing to observe the legal criteria on the basis of which a party can be deemed to have waived the confidentiality of communications between lawyer and client. According to Niche, under the case-law of the European Court of Human Rights, such a waiver must be knowing and intelligent and attended by minimum safeguards commensurate with its importance. However, that is not, in its view, the situation in the present case.

193    In March 2009, Niche, which was at the time represented by a lawyer, had asked the Commission to give confidential treatment to an email of 5 February 2005 from its intellectual property counsel, which that institution agreed to do, before taking the view, in Niche’s view wrongly, that Niche had subsequently waived the confidential treatment that it had originally requested.

194    In that respect, according to Niche, the warning contained in the letter of 20 July 2011, in which the Commission noted the significance of the legal consequences of that waiver, cannot, because it was worded too generally, be regarded as sufficient to protect that undertaking’s rights. In Niche’s view, it was incumbent on the Commission to explain why the documents in question could no longer benefit from confidential treatment. Niche states that it could not have waived its right knowingly and intelligently without understanding the criteria and reasons on the basis of which the Commission was rejecting a request for confidential treatment that it had previously accepted. Niche submits that the confidentiality of communications exists irrespective of whether the undertaking is represented by a lawyer. There is no evidence that the Commission alerted Niche to a misapprehension as to how confidential treatment could be requested even though it was no longer represented by a lawyer.

195    Furthermore, in the event of disagreement as to whether confidential treatment could be granted, that disagreement should have been referred to the hearing officer.

196    By the second part, Niche submits that the General Court erred in law in paragraph 68 of the judgment under appeal by holding that such an infringement of the rights of the defence could not give rise to the annulment of the decision at issue. The Commission cannot, as a matter of principle, rely on an item of evidence obtained in infringement of the rights of the defence. Furthermore, without the email of 5 February 2005, the Commission would not have been able to prove the parties’ anticompetitive intent and to characterise the Niche agreement as a restriction of competition by object.

197    The Commission disputes that line of argument.

*Findings of the Court*

198    In relation to proceedings concerning the application of Article 101 TFEU, the Court has already held that the privileged nature of correspondence between lawyers and their clients is among the rights of the defence that must be respected at the preliminary inquiry stage (see, to that effect, judgments of 18 May 1982, *AM & S Europe* v *Commission*, 155/79, EU:C:1982:157, paragraphs 18 to 23, and of 17 October 2019, *Alcogroup and Alcodis* v *Commission*, C‑403/18 P, EU:C:2019:870, paragraph 50 and the case-law cited).

199    Furthermore, as the General Court pointed out in paragraph 61 of the judgment under appeal, it is apparent from the case-law of the Court of Justice that, if the holder of evidence obtained by the Commission decides, in full knowledge of his or her rights, not to object to its use by the Commission despite being able to do so, that person cannot take issue with the Commission for having used that evidence in its investigation (see, to that effect, judgment of 18 May 1982, *AM & S Europe* v *Commission*, 155/79, EU:C:1982:157, paragraph 28).

200    It should also be recalled that Article 48(2) of the Charter of Fundamental Rights of the European Union (‘the Charter’), according to which respect for the rights of the defence of anyone who has been charged is guaranteed, corresponds to Article 6(3) of the Convention for the Protection of Human Rights and Fundamental Freedoms, signed at Rome on 4 November 1950 (‘the ECHR’). According to Article 52(3) of the Charter, which is intended to ensure the necessary consistency between the rights contained in the Charter and the corresponding rights guaranteed by the ECHR without adversely affecting the autonomy of EU law, the Court, when interpreting the rights guaranteed by Article 48(2) of the Charter, must, therefore, take account of the corresponding rights guaranteed by Article 6(3) ECHR, as interpreted by the European Court of Human Rights, as the minimum threshold of protection (see, to that effect, judgment of 2 February 2021, *Consob*, C‑481/19, EU:C:2021:84, paragraphs 36 and 37).

201    However, according to the case-law of the European Court of Human Rights, as summarised in particular in paragraph 115 of the judgment of 12 May 2017 *Simeonovi v. Bulgaria* (CE:ECHR:2017:0512JUD002198004), neither the letter nor the spirit of Article 6 ECHR prevents a person from waiving of his or her own free will, either expressly or tacitly, the entitlement to the guarantees of a fair trial. Nevertheless, such a waiver must be established in an unequivocal manner and be attended by minimum safeguards commensurate to its importance. It need not be explicit, but must be voluntary and constitute a knowing and intelligent relinquishment of a right. Before an accused can be said to have implicitly, through his or her conduct, waived an important right under Article 6, it must be shown that the person concerned could reasonably have foreseen what the consequences of that conduct would be. Moreover, the waiver must not run counter to any important public interest.

202    In the present case, the General Court found that Niche had expressly waived the confidentiality of the email of 5 February 2005 and that that undertaking had, at the Commission’s subsequent request, unambiguously confirmed its intention. It also noted that the Commission had repeatedly drawn Niche’s attention to the consequences of that waiver, while advising that undertaking to use the services of a lawyer.

203    In thus ascertaining the circumstances in which Niche had waived its right to the confidentiality of that email, the General Court did not fail to observe the case-law principles referred to in paragraphs 198, 199 and 201 of the present judgment, but applied criteria embodying those principles. Nor can the General Court be found to have failed to observe the principle of sound administration when it held, in the light of the circumstances of the present case, that the Commission exercised all due diligence in order to satisfy itself that Niche was able properly to evaluate its waiver of the right to assert the confidentiality of its email of 5 February 2005.

204    Niche also claims that it was necessary to refer the matter of the confidentiality of the email of 5 February 2004 to the hearing officer for determination. However, that argument must be rejected since not only is it unclear and imprecise and not based on any legal reasoning but it criticises the General Court for failing to find an infringement of a right of which Niche did not avail itself.

205    Since the first part of the seventh ground of appeal is not well founded, it must be rejected.

206    The second part is based on the premiss that Niche’s rights of the defence were infringed. Since that premiss has been rejected, that second part is also unfounded.

207    Having regard to the foregoing, the seventh ground of appeal is rejected.

***The eighth ground of appeal, alleging breach of the principle of proportionality***

*Arguments of the parties*

208    By its eighth ground of appeal, Niche submits that the General Court erred in law when it held, in paragraph 367 of the judgment under appeal, that the economic capacity of an offender is no longer a relevant factor for determining the gravity of an infringement or the proportionality of a fine. Even though that factor no longer formed part of the Commission’s methodology for calculating fines, it is nevertheless true, according to Niche, that it was still part of the Court of Justice’s ‘*acquis*’ by virtue of the principle of proportionality. The General Court should therefore, in the exercise of its unlimited jurisdiction, have taken into account the fact that the fine, which was the authorised maximum amount of 10% of Unichem’s worldwide turnover, far exceeded Niche’s financial capacity.

209    The Commission disputes that line of argument.

*Findings of the Court*

210    It should be noted that, in paragraph 367 of the judgment under appeal, the General Court held that the ‘effective economic capacity of offenders to cause significant damage to other operators’ criterion referred to in the Guidelines on the method of setting fines imposed pursuant to Article 15(2) of Regulation No 17 and Article 65(5) of the ECSC Treaty (OJ 1998 C 9, p. 3) as one of the factors for assessing the gravity of an infringement did not apply in the present case because new guidelines had come into force, in 2006, which no longer included such a criterion.

211    Contrary to what is stated in the eighth ground of appeal, that finding by the General Court, in paragraph 367 of the judgment under appeal, does not relate to whether the resources of the undertaking concerned should be taken into consideration in order to determine the amount of the fine, but to the separate issue of whether the effective capacity of an offender to cause significant harm to competition is relevant for the purposes of assessing the gravity of the infringement concerned. The eighth ground of appeal is therefore based on a misreading of the judgment under appeal.

212    Even if the eighth ground could be interpreted as meaning that Niche is criticising the General Court, in broad terms, for failing to have regard, in the exercise of its unlimited jurisdiction, to whether the fine was proportionate in the light of Niche’s limited resources and the difficulties it was facing, that reproach must also be found to be based on a misreading of the judgment under appeal. It can be seen from paragraph 368 of that judgment that the General Court held that Niche did not avail itself of the option of requesting a reduction in the fine on the grounds of its inability to pay, in accordance with point 35 of the Guidelines on the method of setting fines imposed pursuant to Article 23(2)(a) of Regulation No 1/2003 (OJ 2006 C 210, p. 2). Niche does not dispute that finding or claim the slightest distortion in that respect. In those circumstances, Niche cannot criticise the General Court for failing to rule on a complaint that it did not raise.

213    In the light of the foregoing, the eighth ground of appeal must be rejected.

**Costs**

214    Under Article 138(1) of the Rules of Procedure of the Court of Justice, which applies to 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.

215    Since the Commission has applied for costs to be awarded against Niche and the latter has been unsuccessful, Niche must be ordered to bear its own costs and to pay those incurred by the Commission.

216    Article 140(1) of the Rules of Procedure, which applies to appeal proceedings by virtue of Article 184(1) thereof, provides that the Member States and institutions which have intervened in the proceedings are to bear their own costs.

217    Consequently, the United Kingdom must bear its own costs.

On those grounds, the Court (First Chamber) hereby:

1.      **Dismisses the appeal;**

2.      **Orders Niche Generics Ltd to bear its own costs and to pay the costs incurred by the European Commission;**

3.      **Orders the United Kingdom of Great Britain and Northern Ireland to bear its own costs.**

|  |  |  |
| --- | --- | --- |
| Arabadjiev | Lenaerts | Xuereb |

|  |  |  |
| --- | --- | --- |
| Kumin |  | Ziemele |

Delivered in open court in Luxembourg on 27 June 2024.

|  |  |  |
| --- | --- | --- |
| A. Calot Escobar |  | A. Arabadjiev |

|  |  |  |
| --- | --- | --- |
| Registrar |  | President of the Chamber |

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[\*](#Footref*)      Language of the case: English.

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