JUDGMENT OF THE GENERAL COURT (Ninth Chamber)
12 December 2018 (*)
(Competition — Agreements, decisions and concerted practices — Market for perindopril, a medicinal product intended for the treatment of cardiovascular diseases, in its originator and generic versions — Decision finding an infringement of Article 101 TFEU — Patent dispute settlement agreement — Technology acquisition agreement — Restriction of competition by object — Balance between competition law and patent law — Fines)
In Case T‑680/14,
Lupin Ltd, established in Maharashtra (India), represented initially by M. Pullen, R. Fawcett-Feuillette, Solicitors, M. Hoskins QC, V. Wakefield, Barrister and M. Boles, Solicitor, and subsequently by M. Hoskins, V. Wakefield, M. Boles, K. Vernon and S. Smith, Solicitors, and lastly by M. Hoskins, V. Wakefield, S. Smith and C. Wall, Solicitor,
applicant,
v
European Commission, represented initially by F. Castilla Contreras, B. Mongin and T. Vecchi, and subsequently by F. Castilla Contreras, B. Mongin and C. Vollrath, acting as Agents, and by B. Rayment, Barrister,
defendant,
APPLICATION under Article 263 TFEU for partial annulment of Commission Decision C(2014) 4955 final of 9 July 2014 relating to a proceeding under Article 101 and Article 102 TFEU [Case AT.39612 — Perindopril (Servier)] in so far as it concerns the applicant, and, in the alternative, for annulment or reduction of the fine imposed on the applicant by that decision,
THE GENERAL COURT (Ninth Chamber),
composed of S. Gervasoni (Rapporteur), President, L. Madise and R. da Silva Passos, Judges,
Registrar: C. Heeren, Administrator,
having regard to the written part of the procedure and further to the hearing on 4 July 2017,
gives the following
Judgment
I. Background to the dispute
A. Perindopril
1 The Servier group, composed of Servier SAS and several subsidiaries (individually or jointly, ‘Servier’), developed perindopril, a medicinal product used in cardiovascular medicine, primarily intended for the treatment of hypertension and heart failure, by inhibiting the angiotensin converting enzyme.
2 The active pharmaceutical ingredient (‘API’) of perindopril, that is to say, the biologically active chemical substance which produces the desired therapeutic effects, takes the form of a salt. The salt used initially was erbumine (or tert-butylamine), which is in its crystalline form on account of the synthesis process applied by Servier.
1. The compound patent
3 The perindopril compound patent (patent EP0049658) was filed with the European Patent Office (EPO) on 29 September 1981. That patent was due to expire on 29 September 2001, but protection was prolonged in a number of EU Member States, including the United Kingdom, until 22 June 2003, in accordance with Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ 1992 L 182, p. 1).
2. Secondary patents
4 In 1988, Servier also filed a number of patents with the EPO relating to processes for the manufacture of the perindopril compound with an expiry date of 16 September 2008: patents EP0308339, EP0308340 (‘the 340 patent’), EP0308341 and EP0309324.
5 Servier filed new patents relating to erbumine and its manufacturing processes with the EPO in 2001, including patent EP1294689 (known as ‘the beta patent’), patent EP1296948 (known as ‘the gamma patent’), and patent EP1296947 (known as ‘the alpha patent’ — ‘the 947 patent’).
6 The 947 patent application relating to the alpha crystalline form of erbumine and the process for its preparation was filed on 6 July 2001 and granted by the EPO on 4 February 2004.
7 Servier also filed national patent applications in several EU Member States before they were parties to the Convention on the Grant of European Patents, which was signed in Munich on 5 October 1973 and entered into force on 7 October 1977. Servier filed, for example, patent applications relating to the 947 patent in Bulgaria (BG 107 532), the Czech Republic (PV 2003-357), Estonia (P 200 300 001), Hungary (HU 225340), Poland (P 348492) and Slovakia (PP 0149-2003). All the patent applications in question were filed on the same date: 6 July 2001. The patents were granted on 16 May 2006 in Bulgaria, on 17 August 2006 in Hungary, on 23 January 2007 in the Czech Republic, on 23 April 2007 in Slovakia and on 24 March 2010 in Poland.
B. The applicant
8 Lupin Ltd is the parent company, registered in India, of the companies which form part of the Lupin group (individually or jointly, ‘Lupin’ or ‘the applicant’).
C. Disputes relating to perindopril
1. Disputes before the EPO
9 Ten generic companies, including Niche Generics Ltd (‘Niche’), Krka Tovarna Zdravil d.d. (‘Krka’), Lupin and Norton Healthcare Ltd, a subsidiary of Ivax Europe which subsequently merged with Teva Pharmaceuticals Ltd (individually or together with other members of the Teva group, ‘Teva’), filed opposition proceedings against the 947 patent before the EPO in 2004, seeking the revocation in full of that patent on grounds of lack of novelty, lack of inventive step and insufficient disclosure of the invention.
10 On 27 July 2006, the EPO’s Opposition Division confirmed the validity of that patent following minor amendments to Servier’s original claims. Seven companies brought an appeal against the Opposition Division’s decision. Niche withdrew from the opposition procedure on 9 February 2005, Krka on 11 January 2007 and Lupin on 5 February 2007. By decision of 6 May 2009, the EPO’s technical board of appeal annulled the decision of the Opposition Division and revoked the 947 patent. Servier’s request for a revision of that decision was rejected on 19 March 2010.
2. Disputes before the national courts
11 The validity of the 947 patent has, moreover, been challenged by generic companies before the courts of certain Member States, notably in the Netherlands and the United Kingdom.
(a) Dispute between Servier and Krka
12 In Hungary, on 30 May 2006, Servier applied for an interim injunction preventing the marketing of a generic version of perindopril placed on the market by Krka, as a result of the infringement of the 947 patent. That application was rejected in September 2006.
13 In the United Kingdom, on 28 July 2006, Servier brought an action for infringement of the 340 patent against Krka before the High Court of Justice (England and Wales), Chancery Division (Patents Court). On 2 August 2006, it also brought an action for infringement of the 947 patent against Krka and applied for an interim injunction. On 1 September 2006, Krka brought a counterclaim for annulment of the 947 patent and, on 8 September 2006, a separate counterclaim for annulment of the 340 patent.
14 On 3 October 2006, the High Court of Justice (England and Wales), Chancery Division (Patents Court) granted Servier’s application for an interim injunction and denied the motion for summary judgment brought by Krka on 1 September 2006 seeking the invalidation of the 947 patent. On 1 December 2006, the infringement proceedings were discontinued as a result of the settlement reached between the parties and the interim injunction was lifted.
(b) Dispute between Servier and Lupin
15 On 18 October 2006, Lupin submitted an application to the High Court of Justice (England and Wales), Chancery Division (Patents Court), for a declaration of invalidity of the 947 patent, as validated in the United Kingdom, and a declaration that the generic version of perindopril which it intended to market in the United Kingdom did not infringe that patent.
(c) Dispute between Servier and Apotex
16 In the United Kingdom, Servier brought an action for infringement before the High Court of Justice (England & Wales), Chancery Division (Patents Court) against the company Apotex Inc. on 1 August 2006, claiming infringement of the 947 patent, since Apotex had launched a generic version of perindopril in the United Kingdom on 28 July 2006. Apotex brought a counterclaim for annulment of that patent. An interim injunction prohibiting Apotex from importing, offering to sell or selling perindopril was obtained on 8 August 2006. On 6 July 2007, the High Court of Justice (England & Wales), Chancery Division (Patents Court) ruled that the 947 patent was invalid because it lacked novelty and inventive step over patent EP0308341. Consequently, the injunction was lifted immediately and Apotex was able to resume selling its generic version of perindopril on the United Kingdom market. On 9 May 2008, the Court of Appeal (England & Wales) (Civil Division) dismissed Servier’s appeal against the judgment of the High Court of Justice (England & Wales), Chancery Division (Patents Court). On 9 October 2008, the High Court of Justice (England & Wales), Chancery Division (Patents Court) awarded damages to Apotex in the amount of 17.5 million pounds sterling (GBP) on account of the loss of revenue suffered during the period when the injunction was in force.
D. Patent dispute settlements
17 Servier entered into a series of settlement agreements with a number of generic companies with which it was involved in patent disputes.
18 On 30 January 2007, Servier entered into a settlement agreement with Lupin (‘the Lupin agreement’).
19 Both parties thus decided to bring an end to the disputes between them concerning perindopril (Clauses 1.1, 1.2 and 1.4 of the Lupin agreement).
20 Moreover, Lupin undertook not to directly or indirectly seek or assist or procure any third party to revoke, invalidate or challenge the 947 patent or any patent held by Servier or its subsidiaries protecting perindopril, in any country other than a specific non-Member State of the European Economic Area (EEA) (Clause 1.3 of the Lupin agreement). Furthermore, Lupin and its subsidiaries were to refrain from selling or offering for sale any pharmaceutical product containing, as an API, ‘perindopril erbumine ... and any salt thereof’ in any country other than a specific non-EEA Member State (Clause 1.6 of the Lupin agreement). Lupin was, however, authorised to market products supplied by Servier or its own perindopril (i) in countries where a generic version of perindopril authorised by Servier was on the market, (ii) in the event that all Servier’s relevant patents had expired or (iii) in countries in which a third party had placed a generic version of perindopril on the market and in which Servier had not brought any application for injunction seeking the prohibition of its sale (Clauses 1.6 and 4.1 of the Lupin agreement).
21 Furthermore, in the context of the Lupin agreement, Servier acquired three perindopril process patent applications filed by Lupin:
– application W0 2004/075889 (EP 1603558 B1) relating to a new process for the preparation of perindopril and salts thereof for EUR 20 million;
– application W0 2006/097941 (EP 1861367 A) relating to a new and improved process for the purification of perindopril for EUR 10 million;
– application W0 2005/037788 (EP 1675827 A1) relating to a new process for the preparation of ‘crystalline perindopril erbumine’ for EUR 10 million.
22 Servier granted Lupin a non-exclusive, non-transferable, non-sublicensable, royalty-free, perpetual and irrevocable licence on those three patent applications for the purposes of manufacturing perindopril in the countries covered by the applications at issue (Clause 3.1 of the Lupin agreement).
23 The Lupin agreement provided, lastly, for the conclusion of a supply contract between the parties within four weeks of the date of signing of the contract (Clause 4 of the Lupin agreement). That contract was not, however, concluded.
E. The Sector Inquiry
24 On 15 January 2008, the Commission of the European Communities decided to open an inquiry into the pharmaceutical sector pursuant to Article 17 of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles [101] and [102 TFEU] (OJ 2003 L 1, p. 1) in order to identify the factors contributing to the decline in innovation in that sector, measured by the number of new medicines reaching the market, and the reasons for the delayed entry into the market of certain generic medicines.
25 The Commission published a preliminary report on the results of its inquiry on 28 November 2008, followed by a public consultation. On 8 July 2009, it adopted a communication giving a summary of its pharmaceutical sector inquiry report. The Commission stated, inter alia, in that communication, that the monitoring of patent settlements concluded between originator companies and generic companies should continue in order better to understand the use of that type of agreement and to identify those agreements that delay generic market entry to the detriment of EU consumers and may constitute an infringement of competition rules. The Commission subsequently published six annual reports on the monitoring of patent settlement agreements.
F. The administrative procedure
26 On 24 November 2008, the Commission carried out unannounced inspections, inter alia, at the applicant’s premises. The Commission sent requests for information to several companies, including the applicant, in January 2009.
27 On 2 July 2009 the Commission decided to open proceedings against Servier and several other companies, including the applicant.
28 In August 2009 and then between December 2009 and May 2012, the Commission sent further requests for information to the applicant. Between 2009 and 2012, the applicant was invited to attend a number of state of play meetings.
29 On 27 July 2012, the Commission issued a Statement of Objections to several companies including the applicant, which submitted its reply on 5 December 2012.
30 Following the hearing of the companies concerned between 15 and 18 April 2013, further state of play meetings were arranged and additional requests for information sent.
31 On 18 December 2013, the Commission granted access to evidence gathered or more widely disclosed after the Statement of Objections and sent the applicant a Letter of Facts to which it replied on 22 January 2014.
32 The Hearing Officer issued his final report on 7 July 2014.
33 On 9 July 2014, the Commission adopted Decision C(2014) 4955 final relating to a proceeding under Article 101 and Article 102 TFEU [Case AT.39612 — Perindopril (Servier)] (‘the contested decision’).
34 Under Article 5 of the contested decision, the applicant infringed Article 101 TFEU by participating in an agreement covering all Member States, except Croatia, for the period starting 30 January 2007 — except as regards Malta, where the infringement started on 1 March 2007, and Italy, where the infringement started on 13 February 2009 — and ending on 6 May 2009, except as regards the United Kingdom, where the infringement ended on 6 July 2007, the Netherlands, where the infringement ended on 12 December 2007, and France, where the infringement ended on 16 September 2008.
35 The Commission imposed a fine of EUR 40 million on Lupin (Article 7(5)(a) of the contested decision). Lupin was also ordered to refrain from repeating the infringement penalised and from any act or conduct having the same or similar object or effect (Article 8 of the contested decision).
Procedure and forms of order sought
36 By application lodged at the Court Registry on 19 September 2014, the applicant brought the present action.
37 Acting on a proposal from the Judge-Rapporteur, the Court decided to open the oral part of the procedure and, by way of measures of organisation of procedure pursuant to Article 89(3)(a) of its Rules of Procedure, put a written question to the parties, requesting them to answer that question at the hearing.
38 At the hearing on 4 July 2017, the parties presented oral argument and their answers to the written and oral questions put by the Court.
39 The applicant claims that the Court should:
– annul the contested decision, in so far as the Commission found that it had infringed Article 101 TFEU;
– in the alternative, annul the fine imposed on it or, in the further alternative, reduce that fine;
– order the Commission to pay the costs.
40 The Commission contends that the Court should:
– dismiss the application;
– order the applicant to pay the costs.
II. Law
41 In its action, the applicant puts forward both a claim for annulment of the contested decision in its entirety and a claim for annulment or reduction of the fine.
A. The claim for annulment of the contested decision
42 In support of its claim, the applicant disputes, on the one hand, the finding of a restriction of competition by object and, on the other hand, the finding of a restriction of competition by effect.
1. The erroneous finding of a restriction of competition by object
(a) Arguments of the parties
43 The present plea comprises three parts, alleging, first, an error of law, secondly, an error of assessment and, thirdly, various criticisms stemming from the Commission’s incorrect definition of the infringement.
44 In the first part of the present plea, the applicant submits that the Commission erred in law in using the inducement criterion to establish the existence of a restriction by object.
45 Thus, according to the applicant, the ‘crux of the Commission’s analysis’ is based on the existence of an anticompetitive inducement provided by the patent holder to the generic company. This is a novel condition which is not found in the case-law.
46 According to the applicant, the case-law cited by the Commission in the contested decision is not relevant. Thus, the judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers (C‑209/07, EU:C:2008:643), does not concern intellectual property rights and does not involve any settlement agreement, the judgment of 30 January 1985, BAT Cigaretten-Fabriken v Commission (35/83, EU:C:1985:32), concerns a contrived conflict rather than a genuine dispute, the judgment of 25 February 1986, Windsurfing International v Commission (193/83, EU:C:1986:75), does not concern a settlement agreement and the relevant passage of the judgment of 27 September 1988, Bayer and Maschinenfabrik Hennecke (65/86, EU:C:1988:448) is an obiter dictum.
47 According to the applicant, the issue of whether or not an inducement exists for the generic company is ‘entirely neutral in competition terms’. That criterion differs from the criterion established by the case-law relating to the sufficient degree of harm to competition. The Commission therefore erred in law.
48 Moreover, requiring a generic company to conclude a settlement agreement solely on the basis of its assessment of the validity of the patent at issue is unrealistic. As a result, first, of the uncertainty which, in a genuine dispute, surrounds the validity of the patent and the existence of an infringement, and, secondly, the financial consequences for the generic company of a decision not to enter the market, that company, according to the applicant, will give up the opportunity to market a generic product only in exchange for compensation which, in most cases, will take the form of a financial transfer.
49 Furthermore, according to the applicant, patent dispute settlements may allow for a more efficient allocation of resources than the pursuit of the dispute to judgment.
50 According to the applicant, an agreement providing for early market entry, that is to say entry before the expiry of the patent at issue, does not constitute sufficient compensation for a generic company since the ability to act swiftly is an essential component of its commercial strategy. The applicant adds that agreements providing for the early market entry of a generic company have an effect on competition that is equivalent to non-marketing and non-challenge clauses, except that the generic manufacturer’s agreement not to put its product on the market applies until a future date agreed between the parties.
51 The applicant challenges the concept of ‘significant inducement’ used by the Commission in the contested decision, as it would require the generic company to reject a beneficial offer and would therefore result in conduct contrary to the rationale behind litigation and settlement between commercial entities. Moreover, application of that concept could result in the generic company bearing the costs, having regard to the procedural rules as applicable in the United Kingdom.
52 The applicant submits that three objectives must be reconciled: competition law, patent law and efficient conduct of litigation. In its view, it is not necessary to adopt a new criterion for reconciling those three objectives. In that regard, the applicant, relying on the case-law of the Courts of the European Union, in particular that relating to what it refers to as ‘ancillary restraints’, submits that not every restriction on the freedom of action of parties constitutes a restriction of competition.
53 In the context of the second part of the present plea, the applicant submits that it did not commit any infringement by object under Article 101 TFEU.
54 The applicant argues that the litigation between it and Servier was a genuine dispute and that the outcome of that dispute was uncertain.
55 Furthermore, the applicant states that it had very good reasons for wanting to settle the dispute.First, it was not able to obtain a marketing authorisation quickly. Secondly, given that other generic companies had already entered the market, or were likely to enter it, the applicant was not going to be in a position to benefit from the significant advantage conferred on the first generic manufacturer to launch its product on the market. Thirdly, in the context of its distribution strategy, the applicant had entered into contracts with another company which had announced its intention to end its partnership with Lupin. Fourthly, the validity of Servier’s patents was challenged by other companies, and the applicant, who was able to rely on a judicial decision in its favour, was not required to pursue its own costly litigation to judgment. Fifthly, the financial compensation offered by Servier was ‘attractive’.
56 The applicant adds that the appropriate framework for dealing with the issue of inducement is not Article 101 TFEU but Article 102 TFEU. It was not obliged to reject the commercially attractive offer made to it or to request that an offer of a lower amount be made to it.
57 The applicant submits that a settlement is of no interest for the patent holder if the other party to the dispute is free to relitigate the same dispute immediately following the settlement. The non-challenge clause was therefore necessary for the conclusion of the Lupin agreement.
58 Furthermore, the applicant submits that the non-marketing clause was necessary for the conclusion of the Lupin agreement. Moreover, in its view, that clause was not absolute in that agreement. The applicant states that it was able to enter the perindopril market on the basis of either authorisation by Servier, or Servier’s inability to prevent the entry of a generic company. In the situations set out in the Lupin agreement, which provide for Lupin’s market entry, it was stated that Servier would supply perindopril to Lupin.
59 The applicant also states that the non-marketing obligation ceased to apply where certain conditions set out in the Lupin agreement were satisfied. In that regard, the applicant relies on certain provisions of the Lupin agreement which, in its view, favour competition because they enable Lupin to enter the market prior to the expiry of the 947 patent.
60 In the context of the third part of the present plea, the applicant criticises the contested decision with regard to the Commission’s definition of the infringement.
61 In the applicant’s view, the Commission has not established that a restriction of competition relating to products other than erbumine was a possibility.
62 Moreover, according to the applicant, it was proportionate to extend the scope of the non-challenge and non-marketing clauses beyond the 947 patent in order to settle any current or potential dispute between the parties relating to perindopril.
63 Servier had established a dense network of patents around perindopril. Thus, even if the applicant had been able to overcome the major obstacle represented by the 947 patent, it would have had to face potential litigation relating to the other patents held by Servier, litigation that was all the more likely given that Servier was an extremely active litigator.
64 The applicant also states that, irrespective of whether it could develop or acquire a product that could be marketed without infringing Servier’s patents, the likelihood that Servier would, in any event, challenge such marketing, was high.
65 The applicant concludes in that regard that, if the Lupin agreement had not covered all relevant patents, there would have been a genuine risk of disputes.
66 The applicant submits, furthermore, that the Commission should have separated, in the Lupin agreement, the part relating to perindopril erbumine and that relating to any other perindopril salt, as that agreement did not constitute an infringement in so far as it related to erbumine.
67 The Commission submits that the general principles it applied for the purposes of assessing the settlement at issue were not novel, but were established by settled case-law.
68 It also submits that an inducement led Lupin to accept restrictions on its market entry, which enabled Servier to protect its ‘rents’. That inducement cannot therefore be regarded as being ‘neutral in competition terms’.
69 The Commission adds that just because a payment may be commercially attractive to the parties, competition law cannot be ignored. Similarly, again according to the Commission, even if the applicant had commercial reasons for settling, that does not justify concluding an agreement that infringes competition law. Moreover, none of the evidence relied on by the applicant establishes, in the Commission’s view, that the adoption of a settlement agreement was imperative.
70 The Commission also takes the view that the case-law on which the applicant bases its challenge of the contested decision does not support the conclusion that that decision is unlawful. The very purpose of the Lupin agreement was to restrict competition. Consequently, according to the Commission, the anticompetitive clauses contained in that agreement cannot be regarded as a necessary adjunct to an agreement that otherwise has a neutral or positive impact on competition.
71 The Commission disputes the applicant’s claim that the non-marketing clause was not absolute. It states, in particular, that the scope of that clause was such that the market launch of the applicant’s product was totally dependent on the choices made by Servier.
72 The Commission disputes the applicant’s claim that the scope of the anticompetitive clauses was proportionate to settling the dispute at issue, relying on the fact, inter alia, that the Lupin agreement was based on litigation which was not anticipated, and even less imminent.
(b) Findings of the Court
73 It is necessary to examine in turn each of the three parts of the present plea, namely, first, the part alleging an error of law, secondly, the part alleging that there was no infringement, and, lastly, the part alleging the incorrect definition of the infringement.
(1) Error of law
74 In order to analyse the first part of the present plea, it is necessary first of all to examine the concept of restriction of competition by object, patent law and the importance of patent settlements so as to be able to determine, subsequently, the manner in which patent settlement agreements and competition law may be reconciled.
(i) Restrictions of competition by object
75 Article 101(1) TFEU provides that all agreements between undertakings, decisions by associations of undertakings and concerted practices which have ‘as their object or effect’ the prevention, restriction or distortion of competition within the internal market are to be prohibited as incompatible with the internal market. According to settled case-law since the judgment of 30 June 1966, LTM (56/65, EU:C:1966:38, p. 249), the alternative nature of those requirements, indicated by the use of the conjunction ‘or’, leads to the need to consider, in the first place, the precise purpose of the agreement at issue, in the economic context in which it is to be applied. Where, however, an analysis of the terms of the agreement at issue does not reveal a sufficient degree of harm to competition, the effects of the agreement should then be considered and, for it to be caught by the prohibition, it is necessary to find that factors are present which show that competition has in fact been prevented, restricted or distorted to an appreciable extent (see judgments of 19 March 2015, Dole Food and Dole Fresh Fruit Europe v Commission, C‑286/13 P, EU:C:2015:184, paragraph 116 and the case-law cited, and of 16 July 2015, ING Pensii, C‑172/14, EU:C:2015:484, paragraph 30 and the case-law cited). However, where the anticompetitive object of an agreement is established, it is not necessary to examine its effects on competition (see judgment of 20 January 2016, Toshiba Corporation v Commission, C‑373/14 P, EU:C:2016:26, paragraph 25 and the case-law cited). Thus, in the contested decision, the Commission rightly pointed out, first, that the anticompetitive object and effect of an agreement are not cumulative but alternative conditions for assessing whether an agreement comes within the scope of the prohibition laid down in Article 101(1) TFEU (recital 1109 of the contested decision) and, secondly, that it is not necessary to show actual anticompetitive effects of conduct where the anticompetitive object of that conduct is proved (recital 1112 of the contested decision).
76 The concept of restriction of competition by object can be applied only to certain types of coordination between undertakings that reveal, by their very nature, a sufficient degree of harm to the proper functioning of normal competition that it may be found that there is no need to examine their effects (see, to that effect, judgments of 30 June 1966, LTM, 56/65, EU:C:1966:38, p. 249; of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraphs 49, 50 and 58 and the case-law cited; of 16 July 2015, ING Pensii, C‑172/14, EU:C:2015:484, paragraph 31; and of 26 November 2015, Maxima Latvija, C‑345/14, EU:C:2015:784, paragraph 20).
77 According to the case-law of the Court of Justice, in order to determine whether an agreement between undertakings reveals a sufficient degree of harm that it may be considered a ‘restriction of competition by object’ within the meaning of Article 101(1) TFEU, regard must be had to the content of its provisions, its objectives and the economic and legal context of which it forms part (see judgment of 16 July 2015, ING Pensii, C‑172/14, EU:C:2015:484, paragraph 33 and the case-law cited). When determining the economic and legal context, it is also necessary to take into consideration the nature of the goods or services affected, as well as the real conditions of the functioning and structure of the market or markets in question (see judgment of 19 March 2015, Dole Food and Dole Fresh Fruit Europe v Commission, C‑286/13 P, EU:C:2015:184, paragraph 117 and the case-law cited). Nevertheless, it must be borne in mind that the examination of the real conditions of the functioning and structure of the market in question cannot lead the General Court to assess the effects of the coordination concerned (see, to that effect, judgment of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraphs 72 to 82), since otherwise the distinction established in Article 101(1) TFEU would lose its effectiveness.
78 In addition, although the parties’ intention is not a necessary factor in determining whether a type of coordination between undertakings is restrictive, there is nothing prohibiting the competition authorities, the national courts or the Courts of the European Union from taking that factor into account (see judgment of 19 March 2015, Dole Food and Dole Fresh Fruit Europe v Commission, C‑286/13 P, EU:C:2015:184, paragraph 118 and the case-law cited). However, the mere fact that an agreement also pursues legitimate objectives is not sufficient to preclude a finding of restriction of competition by object (judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers, C‑209/07, EU:C:2008:643, paragraph 21; see also, to that effect, judgments of 8 November 1983, IAZ International Belgium and Others v Commission, 96/82 to 102/82, 104/82, 105/82, 108/82 and 110/82, EU:C:1983:310, paragraph 25, and of 6 April 2006, General Motors v Commission, C‑551/03 P, EU:C:2006:229, paragraph 64).
79 It should also be noted that the practices listed in Article 101(1)(a) to (e) TFEU do not constitute an exhaustive list of prohibited collusion (judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers, C‑209/07, EU:C:2008:643, paragraph 23) and that, even though experience may undoubtedly show that certain types of cooperation are inherently harmful to competition (judgment of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraph 51), the fact that the Commission has not, in the past, considered that a certain type of agreement was, by its very object, restrictive of competition is not, in itself, such as to prevent it from doing so in the future following an individual and detailed examination of the measures in question (see judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 438 and the case-law cited).
80 Similarly, the mere fact that a case-by-case approach is necessary in order to identify a restriction of competition by object does not preclude such a classification. The case-law does not require that an agreement be considered to be prima facie or undoubtedly sufficiently harmful to competition, without a concrete and individual of its content, its purpose, and its legal and economic context by the Commission or the EU judicature, in order to be regarded as a restriction on competition by object within the meaning of Article 101(1) TFEU (see, to that effect, judgments of 14 March 2013, Allianz Hungária Biztosító and Others, C‑32/11, EU:C:2013:160, paragraph 51, and of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 775).
81 In the present case, the Commission, in the contested decision, correctly set out the case-law on the definition of restriction of competition by object, as referred to in paragraphs 75 to 78 above. It can be seen from recitals 1109, 1110, 1112 to 1117 and 1211 of the contested decision that the Commission set out that case-law without erring in law and that it also applied that case-law in its analysis of each agreement (see, inter alia, recitals 1369 to 1375, 1475 to 1481, 1622 to 1627, 1763, 1804 to 1810 and 1994 to 2000 of the contested decision). It is irrelevant that the Commission did not use the words ‘sufficient degree of harm’ in the contested decision, since it is apparent from that decision that it correctly grasped the concept of restriction of competition by object. In particular, it indicated in recitals 1110 and 1113 of that decision that those restrictions were ‘those which, “by their very nature”, can be regarded as being injurious to the proper functioning of normal competition’, that, ‘in order to assess if an agreement involves a restriction by object, regard must be had inter alia to the content of its provisions, the objectives it seeks to attain and the economic and legal context of which it forms a part’, and that ‘when determining that context, it is also appropriate to take into consideration the nature of the goods or services affected, as well as the real conditions of the functioning and structure of the market or markets in question’. It also rightly noted that, ‘although the parties’ intention is not a necessary factor in determining whether an agreement involves a restriction of competition by object, there is nothing prohibiting the Commission or the Courts of the Union from taking that aspect into account’ (recital 1113 of the contested decision).
82 Thus, the Commission adopted an approach consistent with the judgment of 11 September 2014, CB v Commission (C‑67/13 P, EU:C:2014:2204), by analysing the Lupin agreement in the light of the criteria referred to in paragraphs 75 to 78 above, which are inherently restrictive since they require the identification of a sufficient degree of harm. The Commission’s analysis did not, a priori, have to apply a more restrictive approach than that entailed by the criteria of the concept of restriction of competition by object, but it required the identification of a restriction of competition showing a sufficient degree of harm or, in the alternative, the assessment of the actual anticompetitive effects of the Lupin agreement.
83 Having set out the conditions for applying the concept of restriction of competition by object and having found that the Commission properly took those conditions into account, it must be noted that, in the present case, the Lupin agreement was intended, according to the applicant, to settle disputes between the contracting parties and was concluded in the specific context of patent law. Since determining whether there is a restriction by object entails an examination of the content of the terms of the agreement in question, its objectives, and its economic and legal context (see paragraph 77 above), it is necessary to analyse the clauses prohibiting challenges to a patent and the clauses prohibiting the marketing of products which infringe that patent contained in settlement agreements in general and in the Lupin agreement in particular, in the light of the objective of settling patent disputes and the specific context, namely that of patents, in order to verify whether the Commission, correctly and in accordance with legally appropriate criteria, classified that agreement as restrictive of competition by object.
(ii) Intellectual property rights and, in particular, patents
84 The specific purpose of awarding a patent is to ensure that its proprietor, in order to reward the creative effort of the inventor, has the exclusive right to use an invention with a view to manufacturing industrial products and putting them into circulation for the first time, either directly or by the grant of licences to third parties, as well as the right to oppose infringements (judgment of 31 October 1974, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraph 9). When granted by a public authority, a patent is normally presumed to be valid and an undertaking’s ownership of that right is presumed to be lawful. The mere possession by an undertaking of such an exclusive right normally results in keeping competitors away, since public regulations require them to respect that exclusive right (judgment of 1 July 2010, AstraZeneca v Commission, T‑321/05, EU:T:2010:266, paragraph 362).
85 The exercise of the rights arising under a patent granted in accordance with the legislation of a Member State does not, of itself, constitute an infringement of the rules on competition laid down by the Treaty (judgment of 29 February 1968, Parke, Davis and Co., 24/67, EU:C:1968:11, p. 71). Intellectual property rules are even essential in order to maintain competition undistorted on the internal market (judgment of 16 April 2013, Spain and Italy v Council, C‑274/11 and C‑295/11, EU:C:2013:240, paragraph 22). First, by rewarding the creative effort of the inventor, patent law contributes to promoting an environment conducive to innovation and investment and, secondly, it is intended to make public the modes of operation of inventions and thus allow further breakthroughs to emerge. Paragraph 7 of the Guidelines on the application of Article [101 TFEU] to technology transfer agreements (OJ 2004 C 101, p. 2; ‘the 2004 Guidelines on technology transfer agreements’), thus acknowledges that there is no ‘inherent conflict between intellectual property rights and the Union competition rules’. According to those provisions, ‘both bodies of law share the same basic objective of promoting consumer welfare and an efficient allocation of resources’, ‘innovation constitutes an essential and dynamic component of an open and competitive market economy’ and ‘intellectual property rights promote dynamic competition by encouraging undertakings to invest in developing new or improved products and processes’. Moreover, according to paragraph 7 of the 2004 Guidelines on technology transfer agreements, ‘so does competition by putting pressure on undertakings to innovate’, and ‘therefore, both intellectual property rights and competition are necessary to promote innovation and ensure a competitive exploitation thereof’. Those provisions were included in their entirety in point 7 of the Guidelines on the application of Article 101 [TFEU] to technology transfer agreements (OJ 2014 C 89, p. 3; ‘the 2014 Guidelines on technology transfer agreements’), which replaced the 2004 Guidelines.
86 According to settled case-law, the right to property, which includes intellectual property rights, constitutes a general principle of EU law (judgment of 29 January 2008, Promusicae, C‑275/06, EU:C:2008:54, paragraph 62; see also, to that effect, judgment of 12 July 2005, Alliance for Natural Health and Others, C‑154/04 and C‑155/04, EU:C:2005:449, paragraph 126 and the case-law cited).
87 However, intellectual property rights, and in particular patent rights, are not absolute; rather they must be viewed in relation to their social function and must be reconciled with other fundamental rights, and they may be restricted in order to meet the objectives of general interest pursued by the European Union, provided that those restrictions do not constitute, in relation to the aim pursued, a disproportionate and intolerable interference, impairing the very substance of the right guaranteed (see judgment of 12 July 2005, Alliance for Natural Health and Others, C‑154/04 and C‑155/04, EU:C:2005:449, paragraph 126 and the case-law cited). For example, the Court of Justice has held, in disputes relating to the interpretation of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ 2009 L 152, p. 1), that it is necessary to balance the interests of the patent-holding pharmaceutical industry and those of public health (see, to that effect, judgment of 12 March 2015, Actavis Group PTC and Actavis UK, C‑577/13, EU:C:2015:165, paragraph 36 and the case-law cited).
88 It should also be borne in mind that Article 3(3) TEU states that the European Union is to establish an internal market, which — in accordance with Protocol No 27 on the internal market and competition, annexed to the Treaty of Lisbon (OJ 2010 C 83, p. 309), which, under Article 51 TEU, has the same legal value as the Treaties — includes a system ensuring that competition is not distorted. Articles 101 and 102 TFEU are among the competition rules referred to in Article 3(1)(b) TFEU which are necessary for the functioning of that internal market. The function of those rules is precisely to prevent competition from being distorted to the detriment of the public interest, individual undertakings and consumers, thereby ensuring the well-being of the European Union (judgment of 17 February 2011, TeliaSonera Sverige, C‑52/09, EU:C:2011:83, paragraphs 20 to 22).
89 Although the treaties have never expressly provided for reconciliation between intellectual property rights and competition law, Article 36 EC (which became Article 30 EC), the provisions of which were reproduced in Article 36 TFEU, nevertheless provided for a reconciliation of intellectual property rights with the principle of free movement of goods, by indicating that the provisions of the Treaty relating to the prohibition of quantitative restrictions between Member States were not to preclude restrictions on imports, exports or goods in transit justified, inter alia, on grounds of the protection of industrial and commercial property, while specifying that those restrictions should not constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. The Court of Justice considers that Article 36 EC thus intended to draw a distinction between the existence of a right conferred by the legislation of a Member State in regard to the protection of artistic and intellectual property, which cannot be affected by the provisions of the Treaty, and the exercise of such right, which might constitute a disguised restriction on trade between Member States (see, to that effect, judgment of 6 October 1982, Coditel and Others, 262/81, EU:C:1982:334, paragraph 13).
90 The EU legislature has moreover had occasion to point out the need for such reconciliation. Thus, Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights (OJ 2004 L 157, p. 45), the objective of which is to approximate national laws so as to ensure a high, equivalent and homogeneous level of protection of intellectual property in the internal market (recital 10 of that directive) and ‘to ensure full respect for intellectual property, in accordance with Article 17(2) of [the Charter of Fundamental Rights of the European Union]’ (recital 32 of that directive), states that it ‘should not affect the application of the rules of competition, and in particular Articles [101] and [102 TFEU]’ and that ‘the measures provided for in this Directive should not be used to restrict unduly competition in a manner contrary to the Treaty’ (recital 12 of that directive).
91 The Court of Justice has developed case-law in relation to various types of intellectual property rights intended to reconcile the competition rules with the exercise of these rights, without affecting their substance, by using the same reasoning as that which allows it to reconcile those rights and the free movement of goods. Thus, for the Court of Justice, the misuse of intellectual property rights must be penalised, but not the lawful exercise of those rights, which it defines on the basis of their specific subject matter, a concept which is used synonymously in the Court’s case-law with the concepts of the actual substance of those rights and the essential prerogatives of their proprietor. According to the Court of Justice, the exercise of the prerogatives which form part of the specific subject matter of an intellectual property right thus concerns the existence of that right (see, to that effect, Opinion of Advocate General Gulmann in RTE and ITP v Commission, C‑241/91 P, EU:C:1994:210, points 31 and 32 and the case-law cited). Nevertheless, the Court of Justice considers that the exercise of the exclusive right by the proprietor may, in exceptional circumstances, also give rise to conduct contrary to the competition rules (judgment of 6 April 1995, RTE and ITP v Commission, C‑241/91 P and C‑242/91 P, EU:C:1995:98, paragraph 50; see also, to that effect, judgment of 17 September 2007, Microsoft v Commission, T‑201/04, EU:T:2007:289, paragraph 691).
92 As regards patents, the Court of Justice has ruled that it is possible that the provisions of Article 101 TFEU may apply if the use of one or more patents, in concert between undertakings, were to lead to the creation of a situation which may come within the concepts of agreements between undertakings, decisions of associations of undertakings or concerted practices within the meaning of Article 101(1) TFEU (judgment of 29 February 1968, Parke, Davis and Co., 24/67, EU:C:1968:11, pp. 71 and 72). It further considered, in 1974, that although the existence of rights recognised under the industrial property legislation of a Member State is not affected by Article 101 TFEU, the conditions under which those rights may be exercised may nevertheless fall within the prohibitions contained in that article and that this may be the case whenever the exercise of such a right appears to be the object, the means or the consequence of a restrictive agreement (judgment of 31 October 1974, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraphs 39 and 40).
93 It must borne in mind that, in the absence of harmonisation of patent law at the European Union level applicable in the present case, the extent of the patent protection conferred by a patent granted by a national patent office or by the EPO can only be determined in the light of rules that do not fall within the scope of EU law but under national law or the Convention on the Grant of European Patents (see, to that effect, judgments of 16 September 1999, Farmitalia, C‑392/97, EU:C:1999:416, paragraph 26; and of 24 November 2011, Medeva, C‑322/10, EU:C:2011:773, paragraphs 22 and 23). Consequently, where, in the context of an action for annulment brought against a Commission decision, the EU judicature is called upon to examine a settlement agreement in relation to a patent governed by rules other than those of EU law, it is not for it to define the scope of that patent or to rule on its validity.
94 While it is not for the Commission or the General Court to rule on the validity of a patent, the existence of the patent must nevertheless be taken into account in the analysis carried out in the framework of the EU competition rules. The Court of Justice has already stated that, although the Commission is not competent to determine the scope of a patent, it is still the case that it may not refrain from all action when the scope of the patent is relevant for the purposes of determining whether there has been an infringement of Article 101 or 102 TFEU, since even in cases where the protection afforded by a patent is the subject of proceedings before the national courts, the Commission must be able to exercise its powers in accordance with the provisions of Regulation No 1/2003, the Commission’s findings do not in any way pre-empt the determinations made later by national courts in disputes brought before them on the subject of patent rights and the Commission’s decision is subject to review by the EU judicature (judgment of 25 February 1986, Windsurfing International v Commission, 193/83, EU:C:1986:75, paragraphs 26 and 27).
95 Lastly, it must be noted that intellectual property rights are protected by the Charter of Fundamental Rights of the European Union. Under Article 17(1) of the Charter of Fundamental Rights, to which the Treaty of Lisbon has conferred the same legal value as the Treaties (Article 6(1) TEU), ‘everyone has the right to own, use, dispose of and bequeath his or her lawfully acquired possessions’, ‘no one may be deprived of his or her possessions, except in the public interest and in the cases and under the conditions provided for by law, subject to fair compensation being paid in good time for their loss’, and ‘the use of property may be regulated by law in so far as is necessary for the general interest’. Article 17(2) of the Charter of Fundamental Rights states, moreover, that ‘intellectual property shall be protected’. Consequently, the guarantees provided for in Article 17(1) of the Charter of Fundamental Rights apply also to intellectual property. The Court of Justice has held that the recognition of intellectual property rights in the Charter of Fundamental Rights entails a need for a high level of protection of those rights and that it is necessary to strike a balance between maintaining free competition — in respect of which primary law and, in particular, Articles 101 and 102 TFEU prohibit anticompetitive agreements, decisions and concerted practices and abuses of a dominant position — and the requirement to safeguard the patent holder’s intellectual property rights, guaranteed by Article 17(2) of the Charter of Fundamental Rights (see, to that effect, judgment of 16 July 2015, Huawei Technologies, C‑170/13, EU:C:2015:477, paragraphs 42 and 58).
(iii) Patent dispute settlements
96 As a preliminary point, it must be noted that the discussion below does not concern patents obtained fraudulently, ‘fictitious’ disputes or disagreements which have not reached the judicial stage. The Commission acknowledged in recital 1170 of the contested decision that, at the time the settlement agreements were concluded, Servier and the generic companies were all parties to, or associated with a dispute before a national court or the EPO concerning the validity of some of Servier’s patents or the infringing nature of the product developed by the generic company.
97 First of all, it should be pointed out that it is a priori legitimate for the parties to a dispute relating to a patent to conclude a settlement agreement rather than pursuing litigation before a court. As the Commission rightly stated in recital 1102 of the contested decision, companies are generally entitled to settle litigation, including patent litigation, and those settlements often benefit both parties to the dispute and allow for a more efficient allocation of resources than if litigation were to be pursued to judgment. An applicant is not required to pursue litigation which it voluntarily initiated. It should be added that the settlement of disputes before the courts, in addition to the fact that it generates a cost for society, cannot be regarded as the preferred and ideal route for conflict resolution. An increase in litigation before the courts may reflect failures or shortcomings which could be remedied in other ways or be dealt with by appropriate prevention actions. If the national systems for granting patents or that of the EPO were experiencing such difficulties, for example by being too liberal in granting protection to processes which are devoid of inventive character, those problems could not justify an obligation, or even an incentive, for undertakings to pursue patent disputes until a judicial outcome is reached.
98 Likewise, paragraphs 204 and 209 of the 2004 Guidelines on technology transfer agreements, which are applicable at the very least to agreements concerning the licensing of technology, acknowledge the possibility of concluding settlement and non-assertion agreements which include the granting of licences and indicate that, in the context of such a settlement and non-assertion agreement, non-challenge clauses are generally considered to fall outside the scope of Article 101(1) TFEU. Point 235 of the 2014 Guidelines on technology transfer agreements, which replaced the 2004 Guidelines, also states that ‘settlement agreements in the context of technology disputes are, as in many other areas of commercial disputes, in principle a legitimate way to find a mutually acceptable compromise to a bona fide legal disagreement’. That paragraph also states that ‘the parties may prefer to discontinue the dispute or litigation because it proves to be too costly, time-consuming and/or uncertain as regards its outcome’, and that ‘settlements can also save courts and/or competent administrative bodies effort in deciding on the matter and can therefore give rise to welfare enhancing benefits’.
99 Moreover, the Commission itself uses an administrative procedure in relation to agreements and concerted practices which is similar in some respects to a settlement agreement. The settlement procedure, which was established by Commission Regulation (EC) No 622/2008 of 30 June 2008 amending Regulation No 773/2004, as regards the conduct of settlement procedures in cartel cases (OJ 2008 L 171, p. 3), is intended to simplify and speed up administrative procedures and to reduce the number of cases brought before the EU judicature, and thus to enable the Commission to handle more cases with the same resources (judgment of 20 May 2015, Timab Industries and CFPR v Commission, T‑456/10, EU:T:2015:296, paragraphs 59 and 60).
100 In addition, according to the case-law, the ability to assert one’s rights through the courts and the judicial control which that entails constitute the expression of a general principle of law which underlies the constitutional traditions common to the Member States and which is laid down in Articles 6 and 13 of the Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950. As access to the courts is a fundamental right and a general principle ensuring the rule of law, it is only in wholly exceptional circumstances that the fact that legal proceedings are brought is capable of constituting an infringement of competition law (judgment of 17 July 1998, ITT Promedia v Commission, T‑111/96, EU:T:1998:183, paragraph 60). As the Court of Justice has noted, the need for a high level of protection for intellectual property rights means that, in principle, the proprietor may not be deprived of the right to have recourse to legal proceedings to ensure effective enforcement of his exclusive rights (judgment of 16 July 2015, Huawei Technologies, C‑170/13, EU:C:2015:477, paragraph 58). Symmetrically, the fact that a company decides to use extrajudicial means of resolving a dispute rather than pursuing the litigation route is merely an expression of the same freedom to choose the means of defending its rights and cannot, in principle, constitute an infringement of competition law.
101 Although access to the courts is a fundamental right, it cannot however be considered that it is an obligation, even if it would help to increase competition between economic operators. First, it should be noted that, despite the wide range of procedures and systems for the grant of patents in the various EU Member States and before the EPO at the time of the facts of the present case, an intellectual property right granted by a public authority is normally presumed to be valid and an undertaking’s ownership of that right is presumed to be lawful (judgment of 1 July 2010, AstraZeneca v Commission, T‑321/05, EU:T:2010:266, paragraph 362). Secondly, while it is indeed in the public interest to eliminate any obstacle to economic activity which might arise where a patent was granted in error (see, to that effect, judgment of 25 February 1986, Windsurfing International v Commission, 193/83, EU:C:1986:75, paragraphs 92 and 93) and while it is generally acknowledged that public budgets, including those dedicated to covering health expenditure, are under significant constraints and that competition, in particular competition provided by generic medicinal products developed by generic companies, can effectively contribute to keeping those budgets under control, it should also be borne in mind, as the Commission rightly stated in recital 1201 of the contested decision, that any undertaking remains free to decide whether or not to bring an action against the patents covering the originator medicinal products held by the originator companies. In addition, such a decision to bring or not to bring an action or to settle a dispute does not, in principle, prevent other undertakings from challenging that patent.
102 It follows from all of the foregoing that, for the purposes of reconciling patent law and competition law in the particular context of settlements between parties to a patent dispute, a balance must be struck between, on the one hand, the need to allow undertakings to make settlements, the increased use of which is beneficial for society and, on the other hand, the need to prevent the risk of misuse of settlement agreements, contrary to competition law, leading to entirely invalid patents being maintained and, especially in the medicinal products sector, an unjustified financial burden for public budgets.
(iv) The reconciliation of patent settlement agreements and competition law
103 It should be noted that the use of a settlement to resolve a patent dispute does not exempt the parties from the application of competition law (see, to that effect, judgments of 27 September 1988, Bayer and Maschinenfabrik Hennecke, 65/86, EU:C:1988:448, paragraph 15, and of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 118; see, by analogy, judgment of 30 January 1985, BATCigaretten-Fabriken v Commission, 35/83, EU:C:1985:32, paragraph 33; see, also, paragraph 204 of the 2004 Guidelines on technology transfer agreements and point 237 of the 2014 Guidelines on technology transfer agreements).
104 The Court of Justice has thus held, in particular, that a non-challenge clause in respect of a patent, including when it was inserted into an agreement intended to settle a dispute pending before a court, might, in the light of the legal and economic context, restrict competition within the meaning of Article 101(1) TFEU (judgment of 27 September 1988, Bayer and Maschinenfabrik Hennecke, 65/86, EU:C:1988:448, paragraphs 14 to 16).
105 It is therefore necessary to identify the relevant factors which justify a conclusion that a non-challenge clause in respect of a patent and, more broadly, a patent settlement agreement restricts competition by object, bearing in mind that determining whether there is a restriction by object entails an examination of the content of the terms of the agreement in question, its objectives, and its economic and legal context (judgment of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraph 53).
106 As a preliminary point, it should be noted that a patent dispute settlement agreement may have no negative impact on competition. That is the case, for example, if the parties agree that the patent at issue is not valid and therefore provide for the immediate market entry of the generic company.
107 The settlement agreement at issue in the present case does not fall into that category because it contains non-challenge clauses in respect of patents and non-marketing clauses in respect of products, which are, by themselves, restrictive of competition. The non-challenge clause undermines the public interest in eliminating any obstacle to economic activity which may arise where a patent was granted in error (see, to that effect, judgment of 25 February 1986, Windsurfing International v Commission, 193/83, EU:C:1986:75, paragraph 92) and the non-marketing clause entails the exclusion from the market of one of the patent holder’s competitors.
108 Nevertheless, the insertion of such clauses may be legitimate, but only in so far as it is based on the parties’ recognition of the validity of the patent in question and, consequently, of the infringing nature of the generic products concerned.
109 First, non-marketing and non-challenge clauses are necessary for the settlement of some disputes related to patents. If the parties to a dispute were unable to make use of such clauses, the settlement of the dispute would be of no interest in cases in which both parties agree on the validity of the patent. It must, moreover, be noted in this connection that the Commission stated, in paragraph 209 of the 2004 Guidelines on technology transfer agreements that ‘it is inherent in [settlement agreements] that the parties agree not to challenge ex post the intellectual property rights covered by the agreement [since] the very purpose of the agreement is to settle existing disputes and/or to avoid future disputes’. It is equally necessary, in order to achieve that purpose, that the parties agree that no infringing product may be marketed.
110 Secondly, the insertion of non-marketing clauses merely, in part, reinforces the pre-existing legal effects of a patent which the parties explicitly or implicitly recognise as valid. A patent normally enables its holder to prevent its competitors from marketing the product covered by the patent or a product obtained through the process covered by the patent (see paragraph 84 above). By agreeing to a non-marketing clause, the generic company undertakes not to sell products likely to infringe the patent in question. If that clause is limited to the scope of the patent at issue, it may be regarded as essentially duplicating the effects of that patent, in so far as it is based on the recognition of the validity of that patent. As regards non-challenge clauses, the patent cannot be interpreted as affording protection against actions brought in order to challenge the validity of a patent (judgment of 25 February 1986, Windsurfing International v Commission, 193/83, EU:C:1986:75, paragraph 92). The effects of those clauses therefore do not overlap with the effects of the patent. However, when a non-challenge clause is adopted as part of the settlement of a genuine dispute in which the competitor has already had the opportunity to challenge the validity of the patent concerned and ultimately acknowledges that validity, such a clause cannot be regarded, in that context, as undermining the public interest in eliminating any obstacle to economic activity which may arise where a patent was granted in error (see paragraph 107 above).
111 The Commission itself stated, in the contested decision, that non-challenge clauses and non-marketing clauses were generally inherent in any settlement. It thus considered that ‘when in a patent dispute or patent litigation, a settlement is reached on the basis of each party’s assessment of the patent case before them, such a patent settlement is unlikely to infringe competition law even though it may contain an obligation on the generic undertaking not to use the invention covered by the patent during the period of patent protection (e.g. a non-compete clause) and/or an obligation not to challenge the patent concerned in court (e.g. a non-challenge clause)’ (recital 1136 of the contested decision).
112 Thus, the mere presence, in settlement agreements, of non-marketing clauses and non-challenge clauses whose scope is limited to that of the patent in question does not — despite the fact that those clauses are, by themselves, restrictive (see paragraph 107 above) — justify a finding of a restriction of competition sufficiently harmful to be described as a restriction by object, where those agreements are based on the recognition, by the parties, of the validity of the patent and, consequently, the infringing nature of the generic products concerned.
113 The presence of non-marketing and non-challenge clauses whose scope is limited to that of the patent in question is, however, problematic when it is apparent that the generic company’s agreement to those clauses is not based on its recognition of the validity of the patent. As the Commission rightly points out, ‘even if the limitations in the agreement [at issue] on the generic undertaking’s commercial autonomy do not go beyond the material scope of the patent, they constitute a breach of Article 101 [TFEU] when those limitations cannot be justified and do not result from the parties’ assessment of the merits of the exclusive right itself’ (recital 1137 of the contested decision).
114 In that respect, it should be noted that the existence of a ‘reverse payment’, that is to say a payment from the originator company to the generic company, is doubly suspect in the context of a settlement agreement. In the first place, it must be borne in mind that a patent is intended to reward the creative effort of the inventor by allowing him to make a fair profit from his investment (judgment of 31 October 1974, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraph 9) and that a valid patent must, in principle, allow a transfer of value to its holder — for example, through a licence agreement — and not vice versa. In the second place, the existence of a reverse payment gives rises to doubts as to whether the settlement is actually based on the recognition, by the parties to the agreement at issue, of the validity of the patent in question.
115 However, the mere presence of a reverse payment does not mean that there is a restriction by object. It is possible that some reverse payments, where they are inherent in the settlement of the dispute in question, may be justified. However, where an unjustified reverse payment occurs in the conclusion of the settlement, the generic company must then be regarded as having been induced by that payment to agree to the non-marketing and non-challenge clauses and it must be concluded that there is a restriction by object. In that case, the restrictions of competition introduced by the non-marketing and non-challenge clauses no longer relate to the patent and to the settlement, but rather can be explained by the conferral of a benefit inducing the generic company to abandon its competitive efforts.
116 It must be pointed out that, although neither the Commission nor the Courts of the European Union are competent to rule on the validity of the patent, it is nevertheless the case that those institutions may, in the context of their respective powers and without ruling on the intrinsic validity of the patent, find that it has been used abnormally, in a manner which has no relation to its specific subject matter (see, to that effect, judgments of 29 February 1968, Parke, Davis and Co., 24/67, EU:C:1968:11, pp. 71 and 72, and of 31 October 1974, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraphs 7 and 8; see also, by analogy, judgments of 6 April 1995, RTE and ITP v Commission, C‑241/91 P and C‑242/91 P, EU:C:1995:98, paragraph 50, and of 4 October 2011, Football Association Premier League and Others, C‑403/08 and C‑429/08, EU:C:2011:631, paragraphs 104 to 106).
117 Inducing a competitor to accept non-marketing and non-challenge clauses, in the sense described in paragraph 115 above, or its corollary, accepting such clauses because of an inducement, constitutes an abnormal use of the patent.
118 As the Commission rightly stated in recital 1137 of the contested decision, ‘patent law does not provide for a right to pay actual or potential competitors to stay out of the market or to refrain from challenging a patent prior to entering the market’. Likewise, according to the Commission, ‘patent holders are not entitled to pay generic companies to keep them off the market and reduce the risks of competition, whether in the context of a patent settlement agreement or otherwise’ (recital 1141 of the contested decision). Lastly, the Commission correctly added that ‘paying or otherwise inducing potential competitors to stay out of the market [was] not part of any patent right, nor [was] it one of the means provided for under patent law to enforce the patent’ (recital 1194 of the contested decision).
119 Where an inducement has been found, the parties may no longer rely on their recognition, in the context of the settlement, of the validity of the patent. The fact that the validity of the patent is confirmed by a judicial or administrative body is, in that regard, irrelevant.
120 It is then the inducement, and not the recognition of the validity of the patent by the parties to the settlement, which must be regarded as the real cause of the restrictions of competition introduced by the non-marketing and non-challenge clauses (see paragraph 107 above), which — since they are in that case entirely illegitimate — therefore reveal a sufficient degree of harm to the proper functioning of normal competition that a restriction by object may be found.
121 Where they involve an inducement, the agreements in question must therefore be regarded as market exclusion agreements, in which the ‘stayers’ are to compensate the ‘goers’. Such agreements actually constitute a buying-off of competition and must therefore be classified as restrictions of competition by object, as follows from the judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers (C‑209/07, EU:C:2008:643, paragraphs 8 and 31 to 34), and the Opinion of Advocate General Trstenjak in Beef Industry Development Society and Barry Brothers (EU:C:2008:467, point 75), referred to in inter alia recitals 1139 and 1140 of the contested decision. Moreover, the exclusion of competitors from the market constitutes an extreme form of market sharing and of limitation of production (judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 435), which, in a context such as that of the Lupin agreement, reveals a degree of harm which is all the greater since the companies excluded are generic companies, the market entry of which is, as a rule, favourable to competition and which also contributes to the public interest in lowering the cost of healthcare. Lastly, that market exclusion is augmented by the fact that it is not possible for the generic company to challenge the patent at issue.
122 It follows from all of the foregoing that, in the context of patent dispute settlement agreements, a finding of a restriction of competition by object presupposes that the settlement agreement contains both an inducement in the form of a benefit for the generic company and a corresponding limitation of the generic company’s efforts to compete with the originator company. Where those two conditions are met, a finding of restriction of competition by object must be made in view of the harmfulness of that agreement to the proper functioning of normal competition.
123 Thus, where a patent settlement agreement contains non-marketing and non-challenge clauses, whose inherently restrictive nature (see paragraph 107 above) has not been validly called into question, the existence of an inducement for the generic company to agree to those clauses permits the conclusion that there is a restriction by object, and does so even if there is a genuine dispute, the settlement agreement includes non-marketing and non-challenge clauses whose scope does not exceed that of the patent at issue and that patent could — having regard, in particular, to the decisions adopted by the competent administrative authorities or courts — legitimately be regarded as valid by the parties to the agreement at issue at the time it was adopted.
124 In the contested decision, the Commission rightly examined whether the settlement agreement at issue in the present case involved a value transfer from the originator company to the generic company representing a ‘significant’ inducement, that is to say liable to lead the latter to accept non-marketing and non-challenge clauses, and concluded, having found such an inducement, that there was a restriction of competition by object.
125 It follows from all the foregoing that the Commission did not vitiate the contested decision by an error of law by applying the inducement criterion for the purpose of distinguishing settlement agreements which constitute restrictions by object from those which do not constitute such restrictions, referred to below as the ‘inducement’ or ‘inducive benefit’ criterion.
126 Nor can such an error of law be inferred from any alleged failure to take into account the context of the Lupin agreement (see, as regards the concept of context, judgment of 11 September 2014, CB v Commission, C‑67/13 P, EU:C:2014:2204, paragraph 53), since it also follows from the foregoing considerations that the inducement criterion is based on an analysis of the substance of the Lupin agreement not only with regard to its stated aim, namely to settle patent disputes, but also its specific context, which is characterised by the presence, in the pharmaceutical sector, of patents constituting exclusive rights which enjoy a presumption of validity and the possession of which normally results in keeping competitors away (see paragraph 84 above). The context in which the Lupin agreement was concluded was given particular attention in the present case since the Commission sought to demonstrate that Lupin was a potential competitor to Servier.
127 The first part of the present plea, alleging an error of law, must therefore be rejected.
128 The foregoing conclusion is not called into question by the applicant’s arguments set out in the following paragraphs.
129 In the first place, as can be seen from the above considerations, and contrary to the applicant’s submissions, the Commission could validly adopt the inducement criterion, relying on the case-law of the Courts of the European Union.
130 In particular, the Commission rightly relied on the judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers (C‑209/07, EU:C:2008:643) and did not, in doing so, disregard the fact that the Lupin agreement concerned intellectual property rights implemented in the context of a dispute settlement.
131 The finding of an inducement implies that the market exclusion of a generic company entailed by the agreement at issue results, not from the effects of the patents at issue and their legitimate use in the context of a settlement, but rather from an inducement, representing the financial consideration for that exclusion, in the same way as the exclusion of certain undertakings from the Irish beef market resulted from financial consideration paid to them by their competitor.
132 It should also be underlined that the Commission fully observed the conditions for the application of competition law to intellectual property rights and the presumption of validity enjoyed by those rights, since it classified as restrictions by object only those agreements that constituted an abnormal use of the patent in that they were based on a financial inducement and not on the recognition of the validity of the patent.
133 Lastly, in view of paragraphs 31 to 34 of the judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers (C‑209/07, EU:C:2008:643), it cannot be concluded that the element of payment in the case that gave rise to that judgment had no effect on the assessment of whether there was a restriction by object. The Court of Justice, after noting that the mechanism at issue was intended to ‘encourage the withdrawal of competitors’, stated that agreements that are intended to enable several undertakings to implement a common policy which has as its object the ‘encouragement’ of some of them to withdraw from the market conflicts patently with the concept inherent in the Treaty provisions relating to competition.
134 The other judgments cited by the Commission in the contested decision, as can be seen from paragraphs 103 to 127 above, do not play a sufficiently decisive role in the Commission’s line of reasoning — which allows it to use the inducement criterion as a means of distinguishing, amongst patent settlement agreements, those which constitute restrictions of competition by object — that any error in their interpretation could be effectively invoked.
135 In the second place, the applicant submits that, because of the legitimate objective of patent settlement agreements, the Commission should have applied the objective necessity test, according to which an agreement may be exempted from the application of Article 101(1) TFEU if it has a legitimate purpose and the restrictions on competition which it imposes are objectively necessary and proportionate.
136 It should be noted in that respect that, according to the case-law, if a given operation or activity is not covered by the prohibition laid down in Article 101(1) TFEU, owing to its neutrality or positive effect in terms of competition, a restriction of the commercial autonomy of one or more of the participants in that operation or activity is not covered by that prohibition either if that restriction is objectively necessary to the implementation of that operation or that activity and proportionate to the objectives of one or the other (see judgment of 11 September 2014, MasterCard and Others v Commission, C‑382/12 P, EU:C:2014:2201, paragraph 89 and the case-law cited). Where it is not possible to dissociate such a restriction from the main operation or activity without jeopardising its existence and aims, it is necessary to examine the compatibility of that restriction with Article 101 TFEU in conjunction with the compatibility of the main operation or activity to which it is ancillary, even though, taken in isolation, such a restriction may appear on the face of it to be covered by the prohibition in Article 101(1) TFEU (judgment of 11 September 2014, MasterCard and Others v Commission, C‑382/12 P, EU:C:2014:2201, paragraph 90).
137 It is true that since increasing the use of settlements to resolve disputes is a legitimate objective (see paragraphs 96 to 101 above), such settlements do not in principle come within the prohibition laid down in Article 101(1) TFEU.
138 However, the Commission was entitled to refrain from examining whether it was necessary to apply the ancillary restraints doctrine, since it considered that the non-challenge and non-marketing clauses were not based on the recognition of the validity of the patent, but on a transfer of value from the originator company to the generics company constituting an inducement, for the latter, not to exert competitive pressure on the former.
139 First, in such a case, the agreement at issue, which is actually a market exclusion agreement (see paragraph 121 above), cannot be characterised as a transaction which is in no way anticompetitive owing to its neutrality or positive effect in terms of competition.
140 Secondly, although a patent dispute settlement agreement which has a neutral or positive effect as regards competition cannot in principle be excluded from the scope of the ancillary restraints doctrine, it is also necessary to examine the scope of the ancillary restriction of competition, which entails an examination of, inter alia, whether the restriction is objectively necessary for the implementation of the main operation or activity (judgments of 18 September 2001, M6 and Others v Commission, T‑112/99, EU:T:2001:215, paragraph 106, and of 29 June 2012, E.ON Ruhrgas and E.ON v Commission, T‑360/09, EU:T:2012:332, paragraph 64).
141 Non-challenge and non-marketing clauses are inherent, and thus necessary, only in some settlements agreements, namely those which are based on the recognition of the validity of the patent or patents in question (see paragraph 109 above). Where there is an inducement, a settlement agreement is not based on that recognition and the non-challenge and non-marketing clauses therein cannot be regarded as being necessary.
142 The Commission was therefore entitled, since it used the inducement as a criterion to identify the agreements that constituted restrictions by object, not to apply the ancillary restraints doctrine to the settlement agreement at issue in the present case.
143 It should be added that the reasoning of the Court of Justice in the judgment of 19 February 2002, Wouters and Others (C‑309/99, EU:C:2002:98, paragraphs 97 and 110), is similar to that applied in relation to ancillary restraints, since the Court of Justice examined, in that judgment, whether an agreement relating to the cooperation between lawyers and members of other professions adopted by a body such as the Bar of a Member State was necessary for the proper practice of the legal profession and therefore for the sound administration of justice, despite the competition-restricting effects inherent in it.
144 It must therefore also be concluded that, since the Commission used the inducement as a criterion to identify the agreements that constituted restrictions by object, it was entitled not to apply the solution adopted in the judgment of 19 February 2002, Wouters and Others (C‑309/99, EU:C:2002:98).
145 In the third place, the argument that the Commission’s reasoning, which is based on the inducement criterion, is ‘unrealistic’ or that it ‘turns on its head’ the process of a settlement between commercial partners cannot be accepted. The competition rules must be respected, even if they lead an undertaking to adopt conduct which is not the most favourable to it or the most rational, in particular from an economic perspective. In that respect, it must be noted that the fact that the adoption of anticompetitive conduct may prove to be the most profitable or least risky solution for an undertaking in no way precludes the application of Article 101 TFEU (see, to that effect, judgments of 8 July 2004, Corus UK v Commission, T‑48/00, EU:T:2004:219, paragraph 73, and of 8 July 2004, Dalmine v Commission, T‑50/00, EU:T:2004:220, paragraph 211), in particular if that behaviour consists in paying actual or potential competitors not to enter the market (see, to that effect, judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraphs 379 and 380).
146 In the fourth place, the fact that a generic company involved in litigation with an originator company might, under national law provisions of a Member State, be penalised as regards costs if it refused to enter into an agreement with the originator company, cannot be taken into account in determining the interpretation to be given to the concept of an infringement of competition law for the purpose of Article 101 TFEU.
147 According to settled case-law, the need for the uniform application of EU law and the principle of equality require that the terms of a provision of EU law which makes no express reference to the law of the Member States for the purpose of determining its meaning and scope must normally be given an autonomous and uniform interpretation throughout the European Union, which must take into account the context of the provision and the purpose of the legislation in question (see judgment of 27 February 2003, Adolf Truley, C‑373/00, EU:C:2003:110, paragraph 35 and the case-law cited). In the present case, Article 101 TFEU makes no express reference to the law of the Member States. In addition, the concept of an infringement of competition law, for the purpose of Article 101 TFEU, is an autonomous concept of EU law in the area of competition law, in respect of which the European Union has exclusive competence under Article 3 TFEU.
148 For the sake of completeness, it should be noted that the Commission states, without being challenged on that point, that the provisions invoked by the applicant leave a margin of discretion to the national court and that there is no basis for the assertion that a national court would penalise a party that rejected a settlement offer which, if accepted, would infringe competition law.
149 It should be added, similarly, that, in the case of a dispute between an originator company and a generic company concerning a patent held by the former, it seems unlikely that the latter, if it won the case before the national court — whether the patent were found to be invalid or not infringed — could be penalised for having refused an offer of a settlement agreement including non-marketing and non-challenge clauses, that is to say an offer based on the recognition of both the validity of the patent and the existence of an infringement. The approach adopted in such a judgment would be contrary to the premiss on which the settlement offer proposed by the originator company was based. It seems unlikely then that, in the context of the discretion available to it, the national court would order the generic company to bear the costs, even though it was entitled, legally, to refuse the settlement offer made to it.
150 In the fifth place, even if the applicant had intended to allege a breach of the principle that offences and penalties must have a proper legal basis because of the novel nature of the infringement found, that argument must be rejected for the reasons set out in paragraphs 272 to 288 below.
151 It follows from all the foregoing that the first part of the present plea in law must be rejected.
(2) The absence of infringement
152 It is necessary to examine in turn the two conditions on the basis of which a restriction by object may be found, namely the inducive benefit for the generic company and the corresponding limitation of its efforts to compete with the originator company (see paragraph 122 above).
(i) The absence of an inducive benefit
153 It follows from Article 2 of Regulation No 1/2003 and from settled case-law that, in the field of competition law, where there is a dispute as to the existence of an infringement, it is incumbent on the Commission to prove the infringements found by it and to adduce evidence capable of demonstrating to the requisite legal standard the existence of the circumstances constituting an infringement (judgments of 17 December 1998, Baustahlgewebe v Commission, C‑185/95 P, EU:C:1998:608, paragraph 58, and of 8 July 1999, Commission v Anic Partecipazioni, C‑49/92 P, EU:C:1999:356, paragraph 86; see, also, judgment of 12 April 2013, CISAC v Commission, T‑442/08, EU:T:2013:188, paragraph 91 and the case-law cited).
154 In that context, any doubt on the part of the Court must operate to the advantage of the undertaking to which the decision finding an infringement was addressed. The Court cannot therefore conclude that the Commission has established the infringement in question to the requisite legal standard if it still entertains any doubts on that point, in particular in proceedings for annulment of a decision imposing a fine (see judgment of 12 April 2013, CISAC v Commission, T‑442/08, EU:T:2013:188, paragraph 92 and the case-law cited).
155 It is necessary to take into account the principle of the presumption of innocence resulting in particular from Article 48 of the Charter of Fundamental Rights. Given the nature of the infringements in question and the nature and degree of severity of the penalties which may ensue, the presumption of innocence applies, inter alia, to the procedures relating to infringements of the competition rules applicable to undertakings that may result in the imposition of fines or periodic penalty payments (see judgment of 12 April 2013, CISAC v Commission, T‑442/08, EU:T:2013:188, paragraph 93 and the case-law cited).
156 In addition, account must be taken of the non-negligible stigma attached to a finding of involvement in an infringement of the competition rules for a natural or legal person (see judgment of 12 April 2013, CISAC v Commission, T‑442/08, EU:T:2013:188, paragraph 95 and the case-law cited).
157 Thus, the Commission must show precise and consistent evidence in order to establish the existence of the infringement and to support the firm conviction that the alleged infringement constitutes a restriction of competition within the meaning of Article 101(1) TFEU (see judgment of 12 April 2013, CISAC v Commission, T‑442/08, EU:T:2013:188, paragraph 96 and the case-law cited).
158 It is not necessary for every item of evidence produced by the Commission to satisfy those criteria in relation to every aspect of the infringement. It is sufficient if the set of indicia relied on by the Commission, viewed as a whole, meets that requirement (see judgment of 12 April 2013, CISAC v Commission, T‑442/08, EU:T:2013:188, paragraph 97 and the case-law cited).
159 The existence of an anticompetitive practice or agreement must sometimes even be inferred from a number of coincidences and indicia which, taken together, may, in the absence of another plausible explanation, constitute evidence of an infringement of the competition rules (judgment of 7 January 2004, Aalborg Portland and Others v Commission, C‑204/00 P, C‑205/00 P, C‑211/00 P, C‑213/00 P, C‑217/00 P and C‑219/00 P, EU:C:2004:6, paragraph 57).
160 For example, although parallel behaviour may not by itself be identified with a concerted practice, it may however amount to strong evidence of such a practice if it leads to conditions of competition which do not correspond to the normal conditions of the market (judgment of 14 July 1972, Farbenfabriken Bayer v Commission, 51/69, EU:C:1972:72, paragraph 25).
161 Likewise, the presence of a ‘side deal’ — the expression used by the Commission in recital 1190 of the contested decision — may constitute, as regards the settlement of a patent dispute, a strong indication of the existence of an inducement and, consequently, of a restriction of competition by object (see paragraphs 115 to 123 above).
162 It should be explained in that respect that a side deal is a normal commercial agreement linked to a settlement agreement which contains clauses which are by themselves restrictive (see paragraph 107 above). Such a link exists, in particular, where the two agreements are concluded on the same day, where they are legally linked, the binding nature of one of the agreements being conditional upon the conclusion of the other agreement, or where, in the light of the context in which they are concluded, the Commission is able to establish that they are indissociable.It may be added that, the shorter the time between the conclusion of each agreement, the easier it will be for the Commission to establish that indissociable nature.
163 It should also be noted that the fact that the settlement agreement and the side deal are concluded on the same day or that there is a contractual link between them is an indication that those agreements form part of a single contractual framework. If those agreements were not concluded on the same day (and if there were no contractual link between them), one of the parties to the negotiation would grant the other party everything it wants without any certainty of ultimately obtaining the expected quid pro quo. That temporal or legal link between the two agreements is also an indication that they were negotiated together.
164 The side deal is a normal commercial agreement that could exist independently without the settlement of a dispute being at issue. Likewise, the conclusion of a settlement agreement does not require the concurrent conclusion of a commercial agreement. Thus, the two agreements do not need to be linked. Moreover, that linkage cannot be justified by the settlement of a dispute, because the purpose of the side deal is not to reach such a settlement but rather to carry out a commercial transaction.
165 In addition, a side deal involves value transfers, of a financial or non-financial nature, between the parties. It may involve, in particular, the transfer of value from the patent holder to the generic company.
166 There is therefore a risk that the linking of a commercial agreement with a settlement agreement containing non-marketing and non-challenge clauses, which are, by themselves, restrictive of competition (see paragraph 107 above), is actually intended — under the guise of a commercial transaction, taking the form, as the case may be, of a complex contractual arrangement — to induce the generic company to accept those clauses, through a value transfer provided for in the side deal.
167 Consequently, the fact that a commercial agreement, which does not normally have the settlement of a dispute as its subject matter (see paragraph 164 above), and which serves as a vehicle for a transfer of value from the originator company to the generic company, is, in the circumstances set out in paragraph 162 above, linked with a settlement agreement containing competition-restricting clauses is a strong indication of the existence of a reverse payment (see paragraph 114 above).
168 However, the strong indication referred to in paragraph 167 above is not sufficient and the Commission must therefore support it with other consistent evidence justifying the conclusion that there is a reverse payment. Such a payment, in the specific context of side deals, corresponds to the part of the payment made by the originator company which exceeds the ‘normal’ value of the asset traded (or, as the case may be, to the part of the ‘normal’ value of the asset traded which exceeds the payment made by the generic company).
169 It should be noted, in that respect, that the Commission, relying on various indicia, including the fact that Lupin gave no guarantee that a patent would be granted, that it would be valid or that the products or processes claimed would be non-infringing (Clause 2.2(a) of the Lupin agreement), stated twice in the contested decision that the acquisition of Lupin’s technology had not been negotiated ‘at arm’s length’ (recitals 1950 and 1952 of the contested decision).
170 It should be noted that the concept of ‘normal competitive conditions’, which is similar to that of ‘arm’s length’, even though it is not used in relation to agreements, decisions and concerted practices, is not alien to competition law, since it is used in the particular field of State aid in order to determine whether a State has acted like a private investor (judgment of 2 September 2010, Commission v Scott, C‑290/07 P, EU:C:2010:480, paragraph 68), that is to say, whether the advantage granted to the undertakings in question constitutes the normal remuneration for a quid pro quo obtained by the State.That concept may therefore constitute, by analogy, a relevant reference parameter when determining whether two companies that concluded a commercial transaction did so on the basis of economic considerations limited to the economic value of the asset traded, that is to say, for example, to its prospects of profitability, and, thus, at arm’s length.
171 Where there are indicia or evidence put forward by the Commission in order to support a finding that the side deal was not concluded at arm’s length, the parties to the agreements may present their version of the facts, supporting their claims with the evidence that they are able to provide and which permit the conclusion that the commercial agreement, although linked to the settlement agreement, is justified by reasons other than the exclusion of a competitor by means of a reverse payment. The parties to the agreements may thus argue that the side deal was concluded at arm’s length by adducing relevant evidence concerning, for example, the industrial and commercial practices in the sector or the particular circumstances of the case.
172 In the light of all the evidence available to it and, as the case may be, the lack of an explanation or the lack of a plausible explanation from the parties to the agreements in question, the Commission may be justified in finding, following an overall assessment, that the side deal was not concluded at arm’s length, that is to say that the payment made by the originator company exceeds the value of the asset traded (or that the value of the asset transferred to the generic company exceeds the payment made by the latter). The Commission may thus conclude that there is a reverse payment (within the meaning of that expression in relation to side deals, see paragraph 168 above).
173 A reverse payment, if it is not intended to compensate for costs inherent in the settlement, therefore constitutes an inducive benefit (see paragraph 115 above). That is the case where the purpose of a side deal is not to settle a dispute but rather to carry out a commercial transaction (see paragraph 164 above).
174 However, the parties to the agreement may still argue that the benefit in question is insignificant, if the amount of that benefit is insufficient to be regarded as a significant inducement to accept the competition-restricting clauses set out in the settlement agreement (see paragraph 124 above).
175 The specific circumstances of the present case must be examined in the light of the foregoing considerations.
176 It should be noted that Servier and Lupin concluded, on the same day, a settlement agreement containing non-marketing and non-challenge clauses and a technology assignment agreement by which Servier purchased from Lupin three patent applications filed by the latter. Moreover, those two agreements were concluded in the form of a single agreement. The link between the two agreements is therefore clear.
177 In addition, the assignment agreement served as a vehicle for a transfer of value from Servier to Lupin.
178 It follows from the foregoing that the assignment agreement constituted a side deal which served as a vehicle for a transfer of value from the originator company to the generic company. It is a strong indication that the transfer of value in question is not merely the quid pro quo for the asset transferred under the side deal, but also involves a reverse payment, within the meaning of that expression in relation to side deals (see paragraph 168 above).
179 Moreover, it is common ground that Servier paid Lupin EUR 40 million under the assignment agreement, which is a significant amount in absolute terms, as the Commission correctly noted in recitals 1871 and 1947 of the contested decision.
180 That amount exceeded the profits that Lupin could expect from its independent market entry during the first two to three years of marketing, as the Commission rightly found in recital 1974 of the contested decision.
181 It is also common ground that the amount in question was greater than the investments made by another comparable generic company, for the purposes of developing its own perindopril, as highlighted by the Commission in recital 1962 of the contested decision.That piece of evidence, relied on by the Commission, is particularly relevant, contrary to the applicant’s submissions.
182 It should be added that Lupin did not transfer patents, but mere patent applications. In addition, it was expressly stipulated in the Lupin agreement that Lupin gave no assurance that a patent would be granted, that it would be valid or that any product or process claimed would be non-infringing (Clause 2.2(a) of the Lupin agreement).
183 Lastly, it is common ground that although, in their replies to the statement of objections, Servier and Lupin both denied that the settlement depended on the terms of the assignment of the patent applications, Lupin had previously stated that the assignment of those applications was an integral part of the discussions concerning the settlement of the dispute. It had also described the payments received as ‘settlement monies’ or ‘settlement sums’ (recital 1937 of the contested decision).
184 The applicant has not produced any evidence to establish that the transfer of value under the assignment agreement corresponded to a transaction carried out at arm’s length.
185 The applicant even states the following in the application:
‘The generic will ... expect something of value in return for giving up its possible entitlement to market its product. The natural means of compensating a generic in such circumstances is the payment by the originator to the generic of a sum of money. Therefore, in many cases, the payment of a significant inducement by the originator to the generic will be an essential part of achieving a
settlement.’
186 A fortiori, the applicant has not adduced any specific evidence to show that the acquisition of Lupin’s patent applications for EUR 40 million could reasonably be regarded as a profitable investment (see, to continue the analogy with the concept of a ‘private investor in a market economy’ begun in paragraph 170 above, paragraph 84 of the judgment of 12 December 2000, Alitalia v Commission, T‑296/97, EU:T:2000:289, in which it is stated that ‘the conduct of a private investor in a market economy is guided by prospects of profitability’) or, at the very least, as being such as to generate income for their acquirer capable of compensating for the high cost of acquiring those applications.
187 Thus, the evidence produced by the applicant does not justify the conclusion that the value transfer at issue corresponded to a transaction carried out at arm’s length.
188 In that respect, it should be noted that the Commission, relying, inter alia, on the case-law cited in paragraph 159 above (recital 1940 of the contested decision), considered that ‘neither Servier nor Lupin were able to provide a plausible description of the factors determining how the final sum of EUR 40 million [had been] reached’ (recital 1955 of the contested decision). The Commission also stated, in recital 1944 of the contested decision, that it was entitled to draw inferences from ‘a situation where potential exculpatory evidence [could] only come from the parties themselves’, and that ‘the parties [were] unable to produce such evidence despite several requests from information’. It added, in recital 1964 of the contested decision, that ‘Servier [had been] unable to produce any contemporaneous documents that would be informative as to the amount of savings expected from acquiring Lupin’s technology’. Lastly, it concluded, in view, inter alia, of ‘the absence of evidence’ of Servier’s commercial interest in the technology transferred by Lupin, that the transfer of value under the assignment agreement represented a significant inducement (recital 1978 of the decision).
189 In view of all of the evidence discussed before the Court, it must be concluded that the Commission established the existence of a reverse payment which was not inherent in the settlement agreement at issue (see paragraph 173 above) and was therefore an inducement.
190 It should be noted that it is not necessary, when finding an infringement, to determine the exact amount of the inducive benefit which corresponds to the part of the value transfer that exceeds the value of the asset traded (see paragraph 168 above).
191 In that respect, it suffices to note, in view of the considerations set out in paragraphs 179 to 190 above, that it has not been established that the benefit in question is insignificant, that is to say, of an amount insufficient to be regarded as a significant inducement to accept the anticompetitive clauses contained in the settlement agreement (see paragraph 174 above).
(ii) The absence of a limitation of the generic company’s efforts to compete with the originator company
192 In the present case, the Lupin agreement contains non-marketing and non-challenge clauses, which, as noted in paragraph 107 above, are, by themselves, restrictive of competition.
193 The applicant submits however that the non-marketing and non-challenge clauses in the Lupin agreement are in no way restrictive of competition, in view of the manner in which other clauses in that agreement limit that restrictiveness. It is necessary to examine the validity of that assertion.
194 As a preliminary point, it must be noted that the products covered by the Lupin agreement are defined in recital A of that agreement, which refers to ‘pharmaceutical products containing, as an active ingredient, perindopril tert-butylamine (also known as perindopril erbumine) and any salt thereof (“the Products”).’
195 Even though recital A of the Lupin agreement refers to ongoing litigation which, at the European level, only concerns the 947 patent, as is apparent from recitals B and D of that agreement, that clause, in view of its wording, does not appear to refer only to products containing perindopril erbumine in its alpha form, that is to say those covered by the 947 patent, but rather all products containing erbumine, regardless of its form.
196 In addition, the expression ‘any salt thereof’ is ambiguous. On the one hand, from a grammatical perspective, the term ‘thereof’ refers more obviously to perindopril tert-butylamine, that is to say erbumine, than to perindopril in its entirety, since the latter is not mentioned, as such, in that part of the sentence. On the other hand, it is not disputed that erbumine is a salt, with the result that the term ‘thereof’ should not refer to erbumine, but, more generally, to perindopril in its entirety.
197 Consequently, it is difficult to determine, in view of the wording of the clauses of the Lupin agreement, whether the products covered by that agreement are limited to the alpha form of erbumine or also include other forms of erbumine, or even other salts of perindopril.
198 In that context of uncertainty, it must be verified whether the scope of the non-marketing and non-challenge clauses was limited to the extent that these clauses were no longer restrictive.
199 In the first place, the restrictive nature of the non-challenge clause is clear, since Clause 1.3 of the Lupin agreement stipulates that:
‘Following the date of this Agreement Lupin shall not directly or indirectly seek or assist or procure any third party to revoke, invalidate or otherwise challenge the Patents or any patent owned by Servier or its affiliates covering the Products in any country other than [a specific non-EEA Member State].’
200 In addition, it is apparent from the separate terms ‘the Patents’ and the ‘Servier Patents’, defined respectively in recital D and Clause 1.3 of the Lupin agreement, that that provision applies not only to the patents referred to in recitals B, C and D (including the 947 patent), which were the subject of litigation between Lupin and Servier, but also, at least potentially, to a series of patents which were not identified by name and which protect the products covered by the Lupin agreement.
201 In the second place, as regards the scope of the non-marketing clause, Clause 1.6 of the Lupin agreement prohibits Lupin from marketing the products referred to in that agreement.
202 It is apparent, however, from the terms of Clause 1.6 of the Lupin agreement that, where the circumstances set out in Clause 4.1 of that agreement apply, Lupin may sell or offer for sale products supplied by Servier or its own products. Clause 4.1 of the Lupin agreement sets out the circumstances in which Servier is required to sell its products to Lupin. Three scenarios are envisaged in that provision.
203 In the first scenario, Lupin may enter one of the national markets covered by the Lupin agreement if some of Servier’s products are marketed by a third party in that market. In the second scenario, Lupin may enter such a market if Servier’s patent application is rejected or if its patent expires, is declared invalid or is revoked. Lastly, in the third scenario, Lupin may enter such a market if a generic product not produced by Servier is sold on that market — unless Servier has applied for an injunction and that application has not been rejected — and the generic medicinal product is not being sold in breach of an injunction applying in that market.
204 Thus, in essence, the market entry of Lupin, including with its own products (see paragraph 202 above), is possible in two cases.
205 First, Lupin may enter the market if Servier authorises the sale of its products by a third party, decides not to submit a patent application or decides not to apply for an injunction, that is to say in circumstances that depend on a discretion on the part of Servier over which Lupin has no influence. In this first case, the application of the circumstances set out in Clause 4.1 of the Lupin agreement cannot be regarded as calling into question, by itself, the restrictive nature of the non-marketing clause (see paragraph 107 above) or, a fortiori, as facilitating Lupin’s market entry.
206 Secondly, Lupin may enter the market if Servier’s patents do not allow it to oppose that entry. In that case, Clause 4.1 of the Lupin agreement does not allow Lupin to make an early market entry in relation to the effects of a patent that is still valid or enforceable. It merely reflects the absence of a valid or enforceable patent, thus avoiding a situation in which the non-marketing clause would be devoid of any link with such a patent and would then clearly show a sufficient degree of harm to the proper functioning of normal competition for it to be classified as a restriction by object (see paragraph 242 below). In this second case, the application of the circumstances set out in Clause 4.1 of the Lupin agreement cannot therefore be regarded as calling into question, by itself, the restrictive nature of the non-marketing clause (see paragraph 107 above) and, a fortiori, as facilitating Lupin’s market entry.
207 The non-marketing clause must therefore be held to be restrictive, despite the provisions of Clause 4.1 of the Lupin Agreement.
208 The above conclusion is not called in question by the other arguments put forward by the applicant.
209 First, the applicant submits that the Lupin agreement allowed Lupin to enter the market early, that is to say before the date on which the validity of the 947 patent was expected to come to an end. According to the applicant, such early entry reduces or even neutralises the competition-restricting nature of a non-marketing clause.
210 It should be noted that, even though that interpretation is not evident due to the complex wording of Clause 1.6 of the Lupin agreement, it could be accepted that that clause, read in conjunction with Clause 4.1(c) of the same agreement, allows the early market entry of Lupin with its own products where a generic ‘Product’ which is not produced by Servier has entered the market without breaching an injunction (and, moreover, where an application for an injunction lodged by Servier is not currently under examination).
211 Since the term ‘Product’, as set out in Clause 4.1(c) of the Lupin agreement, begins with an upper-case letter, it must be understood within the meaning of the definition given in recital A of that agreement, where that term is defined with an upper-case first letter (see paragraph 194 above).
212 In the light of recital A of the Lupin agreement, which seems to refer to products containing erbumine, regardless of its form (see paragraph 195 above), Clause 4.1(c) of that agreement could be interpreted, where it refers to products which are not sold in breach of an injunction, as referring to products containing forms of erbumine other than the alpha form. Thus, the Lupin agreement could be interpreted as authorising Lupin to enter the market after a third party has entered the market with generic perindopril containing a non-alpha form of erbumine.
213 In addition, the ambiguous wording of recital A of the Lupin agreement also creates uncertainty as to whether Clause 4.1(c) of that agreement could be interpreted, where it refers to products which are not sold in breach of an injunction, as also referring to products not containing erbumine (see paragraph 196 above). That could then lead to the conclusion that the agreement authorised Lupin to enter the market after a third party has entered the market with any generic perindopril in the form of a salt, including a salt other than erbumine.
214 The Lupin agreement could therefore be interpreted as providing for the market entry of Lupin, with its own products, before the expected end date of the validity of the 947 patent, since any marketing by a third party of products which do not contain the alpha form of erbumine — because it could not breach an injunction protecting that patent — would in turn allow Lupin to enter the market with its own products.
215 However, because of the uncertainties surrounding the scope of Clauses 1.6 and 4.1 of the Lupin agreement, set out in paragraphs 209 to 213 above, Lupin could fear that the non-marketing clause would continue to apply after a third party had entered the market with generic perindopril composed of a non-alpha form of erbumine or generic perindopril not composed of erbumine. That doubt was such as to deter it from entering the market. There was additional uncertainty due to the fact that, even if the term ‘Product’ were interpreted broadly (as covering any salt of perindopril), Servier could nevertheless apply for an injunction, even in respect of a product which clearly did not infringe any of its patents, in particular the 947 patent, which would effectively prevent the application of Clause 4.1(c) of the Lupin agreement until that application was rejected.
216 Consequently, the non-marketing clause must be found to be restrictive irrespective of the interpretation given to recital A of the Lupin agreement, especially since the uncertainties arising from the complexity of an agreement or the ambiguity of its wording must not allow the parties to avoid liability as regards competition law.
217 Even if the interpretation of the Lupin agreement presented in paragraph 214 were accepted, the hypothetical nature of the events mentioned at the end of paragraphs 212 and 213 above — that is to say the marketing of a generic product by a third party — precludes the conclusion that the restrictive nature of the non-marketing clause is neutralised and that therefore there is no infringement in that respect. It is necessary to distinguish between, on the one hand, the issue of the very existence of the infringement, which cannot be called into question by the mere possibility that future events may occur, and, on the other hand, that of the duration of the infringement, which may depend on the actual occurrence of such events.
218 In addition, the early entry of Lupin depends, in any event, on the marketing of a generic product by a third party, that is to say a circumstance which is both unconnected with the parties to the agreement and uncertain. That entry is therefore not the result of a clear choice of those parties on which they could rely in order to establish that the agreement between them — and, in particular, the non-marketing clause in that agreement — is not restrictive of competition.
219 Secondly, it is true that the Lupin agreement provides in Clause 4.2 for the future conclusion of a supply agreement between the parties. However, the implementation of such an agreement depends on the occurrence of one of the circumstances envisaged in Clause 4.1 of the Lupin agreement. Since, as has just been indicated, the implementation of that latter clause does not justify the conclusion that the non-marketing clause is not restrictive, the same is true of the supply agreement mentioned in Clause 4.2 of the Lupin agreement.
220 In addition, it may be observed that no supply agreement has been concluded between the parties. Furthermore, the Lupin agreement did not provide that failure to adopt a supply agreement would have significant legal consequences for the parties, such as, for example, termination of the Lupin agreement as a whole or of the non-marketing and non-challenge clauses in it. Thus, even if a supply agreement could be regarded as being likely to facilitate the market entry of a generic company that would be a potential competitor of the originator company, in the present case, the Lupin agreement, which merely provided for a supply agreement in principle, without providing for measures or sanctions to ensure the implementation of that agreement, could not be regarded as facilitating Lupin’s market entry.
221 Admittedly, it is clear from Clause 4.2 of the Lupin agreement that the supply agreement was supposed to enable the application of Clause 4.1 of the Lupin agreement, which stipulated an ‘irrevocable’ commitment on Servier’s part to supply the ‘Products’, within the meaning of the agreement, to Lupin. However, the binding nature of Servier’s commitment must be put in perspective in the light of the considerations set out in paragraph 220 above.
222 It follows from the foregoing that the Commission was entitled to conclude that there was a limitation of Lupin’s efforts to compete with Servier.
(iii) The absence of infringement
223 In view of the considerations set out in the two foregoing parts, it may be observed that the Commission rightly found both an inducive benefit and a corresponding limitation of Lupin’s efforts to compete with Servier.
224 As noted in paragraph 122 above, in the context of patent dispute settlement agreements, a finding of a restriction of competition by object presupposes that the settlement agreement contains both an inducive benefit to the generic company and a corresponding limitation of the generic company’s efforts to compete with the originator company. Where these two conditions are met, it must be found that there has been an inducement.
225 In the case of a patent settlement agreement containing non-marketing and non-challenge clauses, the inherently restrictive nature of which has not been validly called into question, the existence of an inducement to the generic company to accept those clauses justifies a finding of a restriction by object (see paragraph 123 above).
226 In the present case, the finding of a significant inducement (see paragraph 191 above) allowed the Commission to find a restriction of competition by object.
227 Consequently, contrary to the applicant’s submissions, the Commission was entitled to find a restriction of competition by object in the contested decision.
228 The foregoing conclusion cannot be called into question by the other arguments put forward by the applicant.
229 In the first place, as regards the applicant’s arguments relating, first, to the existence of a genuine dispute, secondly, to the opportunity that the conclusion of a settlement agreement represented for Lupin in view, inter alia, of the situation of uncertainty in which it found itself, thirdly, to the possibility for Lupin to rely on the outcome of proceedings brought by other undertakings, such as Apotex, against Servier’s patents and, fourthly, the necessity of non-marketing and non-challenge clauses in order to reach such a settlement, it suffices to point out that those arguments are not such as to call into question either the existence of an inducive benefit or the fact that the non-marketing and non-challenge clauses in the Lupin agreement are restrictive of competition by object.
230 Consequently, even if those arguments were based on established facts, they would not be capable, in any event, of invalidating the Commission’s finding of an inducement and, consequently, its finding of a restriction by object.
231 In the second place, although the applicant maintains that it was not required to reject the commercially attractive offer made to it or to request an offer of a lower amount, the commercial attractiveness of an offer does not guarantee that it complies with the competition rules. In that respect, it should be borne in mind that the fact that the adoption of anticompetitive conduct may prove to be the most profitable or least risky solution for an undertaking in no way precludes the application of Article 101 TFEU, in particular if that behaviour consists in paying actual or potential competitors not to enter the market (see the case-law cited in paragraph 145 above).
232 In addition, an undertaking is required to refuse an offer that would cause it to infringe the competition rules. Inducing a competitor to accept non-marketing and non-challenge clauses, or its corollary, accepting such clauses because of an inducement, constitute an abnormal use of the patent (see paragraph 117 above), contrary to competition law.
233 Furthermore, as regards the argument that the assignment agreement should have been examined in the light of Article 102 and not Article 101 TFEU, it must first of all be highlighted that the infringement found by the Commission arises from an agreement and not from unilateral conduct. It may also be noted that the applicant has neither established nor alleged — even assuming that such an argument could be effectively invoked — that it was forced to sign the settlement and assignment agreements contained in the Lupin agreement, without any possibility of resisting, and that, absent genuine consent on its part, those agreements do not fall within the scope of Article 101 TFEU.
234 Accordingly, the second part of the present plea in law must be rejected.
(3) The criticisms concerning the Commission’s definition of the scope of the infringement
235 In the third part of the present plea, the applicant, relying on the scope of the non-marketing and non-challenge clauses, criticises the Commission’s definition of the scope of the infringement in the contested decision.
236 As indicated in paragraph 197 above, it is difficult to determine, in the light of the wording of the clauses of the Lupin agreement, whether the products covered by that agreement were limited to the alpha form of erbumine or whether they also included other forms of erbumine, or even other salts of perindopril.
237 The scope of the non-marketing clause depends on the definition of the concept of ‘Products’ used in the Lupin agreement, since both Clause 1.6 and Clause 4.1 thereof, to which Clause 1.6 refers, make reference to that concept.
238 In addition, as regards the scope of the non-challenge clause, that clause applied not only to the patents referred to in recitals B, C and D of the Lupin agreement (including the 947 patent), but also to a series of patents which were not identified by name and the determination of which depended on the concept of ‘Products’, as defined in that agreement (see paragraph 198 above).
239 As the Commission rightly indicated in the contested decision (recital 1912 of that decision), the wording of the Lupin agreement generated uncertainty as to the scope of the non-marketing and non-challenge clauses.
240 Thus, the wording of the Lupin agreement generated doubts as to whether the non-marketing clause could apply to any form of erbumine, or even to salts of perindopril other than erbumine, and whether the non-challenge clause could apply to patents other than the 947 patent, including patents covering products which do not contain erbumine. That doubt was likely to deter Lupin from, on the one hand, entering the market, including with products containing forms of erbumine other than the alpha form, or salts of perindopril other than erbumine, and, on the other hand, from challenging patents covering perindopril containing forms of erbumine other than the alpha form, or salts of perindopril other than erbumine.
241 Given that the uncertainty arising from the complexity of an agreement or the ambiguity of its wording must not allow the parties to avoid liability under competition law (paragraph 216 above) — particularly since in this case they had sufficient means to seek the assistance of capable professionals, even within a short period, in order to limit the ambiguities in question — the Commission was entitled to conclude that the infringement extended to products not containing erbumine and, a fortiori, containing forms other than the alpha form protected by the 974 patent (recitals 1912, 1918 and 1919 of the contested decision).
242 In that respect, it should be noted that the existence of non-marketing and non-challenge clauses whose scope exceeds that of a specifically identified patent and the products covered by it reveals a sufficient degree of harm to the proper functioning of normal competition for their inclusion to be classified as a restriction by object, without it even being necessary to prove, in addition, the existence of an inducement. Those clauses cannot, in that case, be justified in any way by the settlement of a dispute in relation to a patent and their restrictive effects do not overlap with the effects of that patent (see paragraphs 108 to 112 above).
243 Even if the Commission had wrongly found that the infringement at issue concerned forms of erbumine other than the alpha form protected by the 947 patent, or salts other than erbumine, such an error, in view of the limited and incidental role of that finding in the Commission’s reasoning, would not be capable of calling into question the Commission’s conclusion concerning the existence of a restriction of competition by object arising from the Lupin agreement. The Commission’s reasoning is based in essence on the existence of an inducement which justifies the conclusion — even if the scope of the restrictive clauses of the settlement agreement is limited to the scope of that patent — that the patent was misused (see paragraphs 103 to 127 above).
244 In addition, the invocation, by the applicant, of the — in its view — proportionality or appropriateness of the scope of the non-marketing and non-challenge clauses is not capable of calling into question the Court’s conclusion in paragraph 227 above. The competition rules must be respected, even if they lead undertakings to adopt conduct which is not the most favourable to them, or even conduct which is unfavourable to them, in particular from an economic perspective (see paragraph 231 above).
245 As regards the argument that in the contested decision the Commission should have treated the part of the Lupin agreement concerning perindopril erbumine and the part concerning any other salt of perindopril separately, since the former did not, according to the applicant, constitute an infringement, it suffices to point out that the Lupin agreement constituted an infringement including as regards the alpha form of erbumine, that is to say the only product covered by the 947 patent.
246 Lastly, as noted in the minutes of the hearing, the applicant indicated at the hearing that it had not intended to invoke in the reply the plea alleging that the Commission failed to demonstrate potential competition between it and Servier. In any event, that plea — the belated presentation of which, at the reply stage, has not been justified in any way by the applicant, which has not identified any matter of fact or law that arose during the written part of the procedure — must be rejected as inadmissible.
247 It follows from the foregoing that the third part of the present plea, as well as that plea in its entirety, must be rejected.
2. The erroneous finding of a restriction of competition by effect
(a) Arguments of the parties
248 The applicant submits that the Commission did not apply the criteria laid down in the case-law for establishing the existence of a restriction by effect in so far as it relied on the existence of significant financial compensation.
249 The applicant relies on the same case-law that it invoked in the first plea, in particular the case-law relating to ‘ancillary restraints’.
250 The Commission points out that the other stages of the analysis in terms of restriction by effect are not disputed by the applicant and it refers, as regards the question of inducement, to the arguments it set out in the context of the first plea.
(b) Findings of the Court
251 It should be noted that where some of the grounds in a decision on their own provide a sufficient legal basis for the decision, any errors in the other grounds of the decision have no effect on its operative part. Moreover, where the operative part of a Commission decision is based on several pillars of reasoning, each of which would in itself be sufficient to justify that operative part, that decision should, in principle, be annulled by the Court only if each of those pillars is vitiated by an illegality. In such a case, an error or other illegality which affects only one of the pillars of reasoning cannot be sufficient to justify annulment of the decision at issue because that error could not have had a decisive effect on the operative part adopted by the Commission (see judgment of 14 December 2005, General Electric v Commission, T‑210/01, EU:T:2005:456, paragraphs 42 and 43 and the case-law cited).
252 As noted in paragraph 75 above, in deciding whether an agreement is prohibited by Article 101(1) TFEU, there is no need to take account of its actual effects once it is apparent that its object is to prevent, restrict or distort competition within the internal market.
253 Consequently, where the Commission bases a finding of infringement both on the existence of a restriction by object and on the existence of a restriction by effect, an error rendering unlawful the ground based on the existence of a restriction by effect does not, in any event, have a decisive effect on the operative part adopted by the Commission in that decision, inasmuch as the ground based on the existence of a restriction by object, which can by itself justify the finding of an infringement, is not vitiated by an illegality.
254 In the present case, it is clear from the examination of the plea alleging errors of law and of assessment in relation to the classification of the Lupin agreement as a restriction of competition by object that the applicant has not established that the Commission erred in concluding, in the contested decision, that the Lupin agreement had as its object the prevention, restriction or distortion of competition within the internal market, within the meaning of Article 101(1) TFEU.
255 The present plea in law must therefore be rejected as ineffective.
256 Since the Court has rejected all of the pleas raised by the applicant in support of its claim for the annulment of the contested decision in so far as the Commission found in that decision that it had infringed Article 101 TFEU, that claim must be rejected.
B. Objection to the fine and its amount
257 The applicant claims that the Court should annul the fine imposed on it or, in the alternative, reduce the amount of that fine.
258 In support of its claim, the applicant raises four separate pleas concerning, first, the novelty of the infringement found by the Commission, secondly, an unjustified difference in treatment between Lupin and Krka, thirdly, the application of a method of calculating the fine that did not take into account the gravity and the duration of the infringement and, fourthly, a failure to take into account the legitimacy of the transfer of value.
259 It is appropriate, in the first place, to examine the plea concerning the novelty of the infringement.
1. Novelty of the infringement
(a) Arguments of the parties
260 The applicant relies on the existence of case-law according to which the novelty of an infringement may justify a reduction of the fine.
261 It also invokes a practice in the Commission’s decisions of not imposing fines or merely imposing symbolic fines when examining new questions of law.
262 The applicant also submits that the Commission’s response in the contested decision to its arguments concerning the novelty of the conduct in question is erroneous.
263 First of all, it submits that it is not possible to establish from the case-law or from the Commission’s earlier decisions that an agreement which has the effect of excluding a generic company from the market constituted an infringement of Article 101 TFEU. It also states that it is clear from the contested decision itself (recital 1136 of that decision) that it is unlikely that a settlement agreement reached on the basis of the parties’ assessment of the possible outcome of the litigation between them infringes competition law even though it may contain anticompetitive clauses.
264 Next, according to the applicant, the fact that a settlement agreement becomes unlawful as a result of the payment of significant financial compensation by the patent holder to the generic company is a novel element which does not follow from the existing case-law.
265 The grant of compensation for the purposes of settling a dispute is a common practice. The novelty of the solution adopted by the Commission is all the more evident in the applicant’s case since the financial compensation was granted as a result of the assignment of patent applications.
266 Having regard to the foregoing, the applicant considers that no fine could be imposed on it other than a symbolic fine.
267 According to the Commission, it is not necessary to consider the infringement found against the applicant to be a novel infringement and, even if that were necessary, the fact that there has not previously been a specific ruling on a particular type of conduct does not preclude a finding of infringement or the imposition of a fine.
268 Moreover, according to the Commission, the applicant was aware of Servier’s strategy and of the lack of diligence demonstrated by Servier in incurring such a significant expense.
269 The Commission also relies on a press article which, in its view, establishes the evident nature of the infringement at issue.
270 In the Commission’s view, having regard to the overall circumstances of the case, there was no basis for a legitimate belief that the settlement agreement concluded in return for a very substantial payment which exceeded its expected profits from market entry, was lawful.
271 Lastly, the Commission states that the applicant accepts that the payment received from Servier had been made in return for concluding the settlement, and was not in exchange for the patent applications assigned by the applicant.
(b) Findings of the Court
272 As a preliminary point, it should be observed that the effective penalisation of infringements of competition law cannot go so far as to disregard the principle that offences and penalties must have a proper legal basis as enshrined in Article 49 of the Charter of Fundamental Rights (see, by analogy, as regards criminal penalties and the Member States’ obligation to counter illegal activities affecting the financial interests of the Union, judgment of 5 December 2017, M.A.S. and M.B., C‑42/17, EU:C:2017:936, paragraph 61).
273 It must next be observed that, according to the case-law of the Court of Justice, the principle that offences and penalties must have a proper legal basis implies that legislation must define clearly offences and the penalties which they attract. That requirement is satisfied where the individual concerned is in a position to ascertain from the wording of the relevant provision and, if need be, with the assistance of the courts’ interpretation of it, what acts and omissions will make him criminally liable (see judgment of 22 October 2015, AC-Treuhand v Commission, C‑194/14 P, EU:C:2015:717, paragraph 40 and the case-law cited).
274 The principle that offences and penalties must have a proper legal basis cannot be interpreted as precluding the gradual, case-by-case clarification of the rules on criminal liability by judicial interpretation, provided that the result was reasonably foreseeable at the time the offence was committed, especially in the light of the interpretation put on the provision in the case-law at the material time (see judgment of 22 October 2015, AC-Treuhand v Commission, C‑194/14 P, EU:C:2015:717, paragraph 41 and the case-law cited).
275 The scope of the notion of foreseeability depends to a considerable degree on the content of the text in issue, the field it covers and the number and status of those to whom it is addressed. A law may still satisfy the requirement of foreseeability even if the person concerned has to take appropriate legal advice to assess, to a degree that is reasonable in the circumstances, the consequences which a given action may entail. This is particularly true in relation to persons carrying on a professional activity, who are used to having to proceed with a high degree of caution when pursuing their occupation. Such persons can therefore be expected to take special care in evaluating the risk that such an activity entails (see judgment of 22 October 2015, AC-Treuhand v Commission, C‑194/14 P, EU:C:2015:717, paragraph 42 and the case-law cited).
276 It should be added that the need for professional advice appears all the more evident where, as was the case here, it is necessary to prepare and draft an agreement intended to prevent or to settle a dispute.
277 In that context, even though, at the time of the infringements found in the contested decision, the Courts of the European Union had not yet had the opportunity to rule specifically on a settlement agreement of the type concluded between Servier and Lupin, the latter should have expected, if necessary after taking appropriate legal advice, its conduct to be declared incompatible with the EU competition rules, especially in the light of the broad scope of the terms ‘agreement’ and ‘concerted practice’ established by the case-law of the Court of Justice (see, to that effect, judgment of 22 October 2015, AC-Treuhand v Commission, C‑194/14 P, EU:C:2015:717, paragraph 43).
278 In particular, the applicant could assume that accepting non-marketing and non-challenge clauses, by themselves restrictive of competition, on the basis of an inducement and not its recognition of the validity of the patent, rendered the inclusion of such clauses in a patent settlement agreement entirely illegitimate and constituted an abnormal use of the patent, unrelated to its specific purpose (see paragraph 117 above). The applicant could therefore reasonably have foreseen that its conduct was caught by the prohibition laid down in Article 101(1) TFEU (see, to that effect, judgments of 22 October 2015, AC-Treuhand v Commission, C‑194/14 P, EU:C:2015:717, paragraph 46, and of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 764).
279 In addition, it must be noted, first, that, well before the date of conclusion of the Lupin agreement, there was case-law on the application of competition law in fields characterised by the presence of intellectual property rights (see, to that effect, judgment of 8 September 2016, Xellia Pharmaceuticals and Alpharma v Commission, T‑471/13, not published, under appeal, EU:T:2016:460, paragraphs 314 and 315).
280 In that regard, it should be noted, first of all, that the Court of Justice held, as early as 1974, that although the existence of rights recognised under the industrial property legislation of a Member State was not affected by Article 101 TFEU, the conditions under which those rights could be exercised might nevertheless fall within the prohibitions contained in that article and that this might be the case whenever the exercise of such a right appeared to be the object, the means or the consequence of an agreement (judgment of 31 October 1974, Centrafarm and de Peijper, 15/74, EU:C:1974:114, paragraphs 39 and 40).
281 Next, since the judgment of 27 September 1988, Bayer and Maschinenfabrik Hennecke (65/86, EU:C:1988:448), it is clear that patent dispute settlements may be categorised as agreements within the meaning of Article 101 TFEU.
282 Secondly, it must be pointed out that, by the Lupin agreement, Lupin and Servier actually decided to conclude a market exclusion agreement (see paragraphs 223 to 226 above). Although it was only in a judgment delivered after the conclusion of the Lupin agreement that the Court of Justice held that market exclusion agreements, in which the ‘stayers’ are to compensate the ‘goers’, constitute a restriction of competition by object, it nonetheless made clear that that type of agreement conflicted patently with the concept inherent in the provisions of the Treaty relating to competition, according to which each economic operator must determine independently the policy which it intends to adopt on the market (judgment of 20 November 2008, Beef Industry Development Society and Barry Brothers, C‑209/07, EU:C:2008:643, paragraphs 8 and 32 to 34). In concluding such an agreement, the applicant could not, therefore, have been unaware of the anticompetitive nature of its conduct.
283 Indeed, although, because the Lupin agreement was concluded in the form of a patent settlement, its unlawful nature might not have been evident to an outside observer such as the Commission, the same could not be said for the parties to that agreement.
284 Thirdly, the conclusion in paragraph 278 above cannot be called into question by the argument alleging that the Commission has a practice of not imposing fines or merely imposing symbolic fines when it examines new questions of law.
285 Despite the novelty of certain issues raised in the present case, Lupin could reasonably have foreseen that, in acting as it did, that is to say by agreeing to be paid to stay out of the market, its conduct was caught by the prohibition laid down in Article 101(1) TFEU (see paragraph 278 above).
286 It has even been noted in paragraph 282 above that Lupin could not have been unaware of the anticompetitive nature of its conduct in the present case.
287 In any event, according to the case-law, the Commission has a margin of discretion when setting the amount of fines, in order that it may channel the conduct of undertakings towards compliance with the competition rules. The fact that in the past the Commission has applied fines of a particular level for certain types of infringements, such as symbolic fines for infringements of an unprecedented nature, does not mean that it is precluded from increasing that level within the limits indicated in Regulation No 1/2003, if that is necessary to ensure the implementation of EU competition policy. The proper application of the EU competition rules in fact requires that the Commission may at any time adjust the level of fines to the needs of that policy (judgment of 8 September 2016, Lundbeck v Commission, T‑472/13, under appeal, EU:T:2016:449, paragraph 773).
288 It follows from all of the foregoing that the present plea must be rejected.
2. The difference in treatment between Lupin and Krka
(a) Arguments of the parties
289 The applicant submits that the Commission treated Krka more favourably than it since, unlike in the present case, the amount paid for the patents assigned from Krka to Servier was not taken into account by the Commission in calculating the basic amount of the fine.
290 The applicant states that it is established in the contested decision that the settlement agreement concluded between Servier and Krka and the assignment agreement concluded between those parties form part of a single and continuous infringement.
291 The Commission submits that it did not consider that the purchase of Krka’s patent applications by Servier constituted a reverse payment.
292 Consequently, in its view, the payment of EUR 30 million by Servier to Krka for the purchase of Krka’s technology could not be taken into account for the calculation of the amount of Krka’s fine, which is based solely on the value transfer that induced Krka to accept the competition-restricting commitments.
(b) Findings of the Court
293 As a preliminary point, it should be noted that, according to the settled case-law of the Court of Justice, when the amount of the fine is determined, there cannot, by the application of different methods of calculation, be any discrimination between the undertakings which have participated in the same infringement of Article 101 TFEU (see judgment of 12 November 2014, Guardian Industries and Guardian Europe v Commission, C‑580/12 P, EU:C:2014:2363, paragraph 62 and the case-law cited).
294 The Courts of the European Union have also held that the Commission’s practice in previous decisions does not itself serve as a legal framework for the fines imposed in competition matters and that decisions in other cases can give only an indication for the purpose of determining whether there is discrimination (judgment of 19 April 2012, Tomra Systems and Others v Commission, C‑549/10 P, EU:C:2012:221, paragraph 104), since the facts of those cases, such as markets, products, the undertakings and periods concerned, are not likely to be the same (judgment of 16 June 2011, Bavaria v Commission, T‑235/07, EU:T:2011:283, paragraph 290).
295 In the present case, although it is common ground that the agreements between Servier and each of the generic companies constituted separate infringements and that, consequently, the case-law cited in paragraph 293 above does not apply, those infringements were formally found and penalised in the same Commission decision and they concern contracts with certain similarities in terms of their subject matter and the context in which they were adopted, since, inter alia, they were concluded with the same originator company. Consequently, a comparison of the fines imposed on those different generic companies is not irrelevant with respect to the principle of equal treatment (see, to that effect, judgment of 27 September 2006, Archer Daniels Midland v Commission, T‑59/02, EU:T:2006:272, paragraph 316).
296 Moreover, it should be noted that, according to settled case-law, the principle of non-discrimination or equal treatment, which is a fundamental principle of law, prohibits comparable situations from being treated differently or different situations from being treated in the same way, unless such difference in treatment is objectively justified (see, to that effect, judgments of 8 October 1986, Christ-Clemen and Others v Commission, 91/85, EU:C:1986:373, paragraph 19, and of 8 January 2003, Hirsch and Others v ECB, T‑94/01, T‑152/01 and T‑286/01, EU:T:2003:3, paragraph 51 and the case-law cited).
297 The applicant submits that the Commission treated Krka more favourably than it since, unlike the amount that it received for the patent applications that it assigned to Servier, the amount paid for the patent applications assigned from Krka to Servier was not taken into account by the Commission in calculating the basic amount of Krka’s fine. That more favourable treatment constitutes, in the applicant’s submission, a breach of the principle of equal treatment.
298 It should be noted first of all that the Commission — applying point 37 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, ‘the Guidelines on the method of setting fines’) — adopted a different method from that set out in those guidelines by using, in order to determine the basic amount of the fines imposed on the generic companies, the inducive transfer of value to each of them. It should also be noted that that transfer of value, which was not in any way adjusted by the Commission, also constitutes the final amount of the fine.
299 Next, as regards Krka, it should be borne in mind that it had concluded with Servier, first of all, two connected agreements, a settlement agreement and a licence agreement allowing Krka to use the 947 patent, and then, several months later, a technology assignment agreement by which Krka assigned its patent applications to Servier for EUR 30 million.
300 With regard to the settlement and licence agreements, the Commission found an infringement by relying on the fact that the licence agreement, through the benefit that it generated for Krka, had induced that company to accept the non-marketing and non-challenge clauses in the settlement agreement (recitals 1731 and 1749 of the contested decision).
301 With regard to the technology assignment agreement, the Commission pointed out that that agreement had enabled Servier to strengthen its competitive position by protecting itself from the threat that generic companies might gain access to that technology (recitals 1805 and 1806 of the contested decision).
302 The Commission considered that the agreements mentioned in the two preceding paragraphs formed part of a single and continuous competition-restricting infringement (recital 1811 of the contested decision). It concluded the section of the contested decision devoted to the analysis of the restriction by object in relation to the various agreements between Servier and Krka by stating that those agreements ‘followed [the] objective to share markets by preventing or limiting generic competition between, or to, Krka and Servier’ (recitals 1812 of the contested decision).
303 The Commission also noted that the sum of EUR 30 million paid to Krka under the technology assignment agreement was not connected to Servier’s expected or actual earnings from the commercial exploitation of the rights in question and was, moreover, greater than the sum which Krka would likely have earned by transferring that technology to other generic companies (recital 1807 of the contested decision). According to the Commission, that payment actually served as a form of rent sharing between the parties (recital 1810 of the contested decision).
304 However, the Commission stated that Servier’s payment of EUR 30 million to Krka under the technology assignment agreement had not constituted an inducement for Krka to accept the non-marketing and non-challenge clauses in the settlement agreement concluded several months before the conclusion of the assignment agreement (recital 1678 and footnote 2419 of the contested decision).
305 In that respect, it should be borne in mind that the fact that a commercial agreement which does not have the settlement of a dispute as its subject matter and which serves as a vehicle for a transfer of value from the originator company to the generic company is linked with a settlement agreement containing competition-restricting clauses is a strong indication of the existence of an inducive reverse payment (see paragraph 167 above). Such a link exists where the two agreements are concluded on the same day, where they are legally linked, or where, in the light of the context in which they are concluded, the Commission is able to establish that they are indissociable (see paragraph 162 above).
306 There was no legal link between the settlement agreement and the technology assignment agreement concluded by Servier and Krka nor were they concluded concomitantly. In addition, the Commission took the view that it was not in a position to establish that those two agreements were indissociable or that, despite the lack of a connection between them, there were other indicia capable of establishing that the assignment agreement generated a reverse payment inducing Krka to accept the restrictive clauses of the settlement agreement.
307 By contrast, the assignment agreement between Lupin and Servier was connected, within the Lupin agreement, to their settlement agreement. The connection between those two agreements was therefore evident (see paragraph 305 above). On the basis of that connection, and other consistent evidence, the Commission concluded that the EUR 40 million payment from Servier constituted an inducement (recital 1978 of the contested decision).
308 It follows from the foregoing that the Commission applied the method adopted for setting the amount of the generic companies’ fines consistently to both Lupin and Krka and that, accordingly, no discrimination has been established (see, to that effect, judgment of 14 September 2017, LG Electronics and Koninklijke Philips Electronics v Commission, C‑588/15 P and C‑622/15 P, EU:C:2017:679, paragraphs 93 to 95).
309 In addition, it has not been established that the Commission misapplied the adopted method to Lupin or to Krka.
310 Lupin has not adduced evidence to support the conclusion that the payment of EUR 30 million made by Servier to Krka under the assignment agreement was inducive, or which casts doubt on the non-inducive nature of that payment.
311 In addition, the Commission rightly concluded that the EUR 40 million payment made by Servier to Lupin was inducive (see paragraphs 189 and 191 above).
312 Thus, Lupin and Krka were in different situations and that difference in their situations justified — given the method adopted by the Commission for setting the amount of the generic companies’ fines (see paragraph 298 above) — the Commission’s decision to treat Krka and Lupin differently, by taking into account in respect of one of them, and not the other, the amount of the transfer of value provided for in the assignment agreements that each of them had concluded.
313 Lastly, even if the Commission were wrong in not increasing the basic amount of the fine imposed on Krka in order to take account of the assignment agreement that that company had concluded with Servier, and Lupin could effectively rely on that error in order to obtain a reduction of the fine imposed on it, it could obtain such a reduction only if it were in a situation comparable to that of Krka, that is to say if it had itself concluded an agreement with Servier which was not a side deal to the settlement agreement but which formed part of a single and continuous infringement with that settlement agreement and if, moreover, the amount of its own fine, unlike that of Krka, had been increased on that basis.
314 However this is not the case.
315 It follows from all of the foregoing that Lupin’s allegation of a breach of the principle of equal treatment is unfounded.
316 The present plea in law must therefore be rejected.
3. The application of a method of calculating the fine that did not take into account the gravity and the duration of the infringement
(a) Arguments of the parties
317 The applicant criticises the method adopted by the Commission for determining the basic amount of each fine, as the Commission relied on the value of the transfer made to the generic company concerned.
318 According to the applicant, that method is contrary to Article 23(2)(a) of Regulation No 1/2003, since it does take into account the gravity and the duration of the infringement.
319 The applicant adds that, whilst the contested decision does, to a certain extent, refer to the gravity and duration of the infringement, these factors were clearly not actually taken into account because the Commission simply fined each undertaking according to the sums received as part of the settlement. Again according to the applicant, mere lip service to gravity and duration is not enough.
320 Furthermore, the Commission infringed the principle of equal treatment by imposing, on the basis of that calculation method, an unfair fine on the applicant. Thus, the applicant was penalised more severely than the other generic companies, even though it was not found in the contested decision that its conduct was more serious or had lasted for longer than that of those other companies.
321 The Commission failed to comply with its obligation to assess specifically the facts of each of the cases before it for the purposes of setting an appropriate amount for the fine.
322 The Commission contends that the calculation method used was appropriate, the amount of the value transfer received providing important indications relating to the gravity and the duration of the infringements.
323 The Commission also submits that the method adopted was consistent with point 37 of the Guidelines on the method of setting fines.
324 It states that, in the absence of any sales of the product in the geographic area concerned during the relevant period, it was necessary to apply a method not based on the value of sales.
325 Moreover, again according to the Commission, the method used was appropriate for ensuring that the fine acted as a deterrent since the amount of the fine is greater than the amount of gains improperly made as a result of the infringement.
326 The Commission states that it applied the same method to all the undertakings concerned and that it took into account the specific features of the case.
(b) Findings of the Court
327 In order to examine whether the Commission, in the contested decision, applied a method of calculating the fine which, in accordance with the provisions of Article 23(3) of Regulation No 1/2003, had regard to the gravity and the duration of the infringement, it is necessary first of all to set out the relevant grounds in the contested decision concerning the method adopted by the Commission and its capacity to take into account the gravity and the duration of the infringement.
328 In that respect, it is true, as the applicant submits, that the Commission indicated in recital 3151 of the contested decision that, in order to determine the basic amount of the fine imposed on each of the generic undertakings concerned, and its final amount (see paragraph 298 above), it had used the value transferred to the generic undertaking concerned in each infringement, ‘without differentiating between the infringements on the basis of various factors of gravity such as nature, market share and geographical scope’.
329 However, in recital 3146 of the contested decision, the Commission also stated that:
‘The generic undertakings agreed not to sell generic perindopril in the geographic area concerned by each agreement and therefore did not have any sales in the geographic areas concerned. Point 37 of the Guidelines on [the method of setting] fines should therefore be applied to the generic undertakings in this case. Point 37 of the Guidelines on [the method of setting] fines allows the Commission to depart from the normal methodology of the Guidelines on [the method of setting] fines because of the particularities of a given case or the need to achieve deterrence in a particular case.’
330 The Commission added the following in recital 3151 of the contested decision:
‘When assessing the gravity of each infringement, the Commission has regard to a number of factors, such as the nature of the infringement, the combined market share of all the undertakings concerned, the geographic scope of the infringement and whether or not the infringement has been implemented. These elements, which form part of a non-exhaustive list, are assessed below in this section for each infringement. Normally the gravity of the infringement determines the percentage of the value of sales taken into account when setting the fine. However, in this case by applying point 37 of the Guidelines on [the method of setting] fines, the Commission determines the basic amount for Niche/Unichem, Matrix, Teva, Krka and Lupin corresponding to the value transferred to the generic undertaking in each infringement.’
331 Lastly, the Commission noted the following in recital 3152 of the contested decision:
‘According to Regulation No 1/2003 and the Guidelines on [the method of setting] fines, the fine should relate to the following factors: (i) the gravity of the infringement, (ii) its duration, (iii) any aggravating or attenuating circumstances and (iv) the need to achieve deterrence. The Commission, in exercising its margin of discretion, considers that in the present case, given its particularities, the amount of the value transfer received by the generic companies provides important indications as to these factors.’
332 The Commission therefore considered, contrary to the applicant’s submissions, that the method that it had adopted for calculating the amount of the fine imposed on the generic companies, which was based on the amount of the value transfer enjoyed by each of the generic companies in question (see paragraph 298 above), allowed it to take adequate account of the specific circumstances of each case and, in particular, the gravity and the duration of each infringement.
333 The applicant disputes however that the amount of the value transfer genuinely reflects the gravity and the duration of the infringement. The method adopted by the Commission is therefore, according to the applicant, contrary to the provisions of Article 23(2)(a) of Regulation No 1/2003.
334 As a preliminary point, it should be noted that Lupin was not present on the market at issue at the time of the infringement, because of the very purpose of the Lupin agreement, which was a market exclusion agreement.
335 It was therefore impossible for the Commission to use, as the amount of the fine, the value of sales made by the generic company on the market in question in one of the years during which the infringement took place. It therefore had to rely on a different value in order to establish the amount of the fine.
336 The Commission used, in that respect, the amount of the value transfer from Servier to Lupin. It rightly considered (see paragraphs 362 to 398 below), that that amount was equivalent to the reverse payment that Lupin had received (see, inter alia, recitals 1978 and 1994 of the contested decision).
337 It should be pointed out that that reverse payment corresponds to the price that the originator company was prepared to pay to exclude a competing generic company from the market and to the price that that generic company was willing to accept to withdraw from the market — a price which was negotiated between those two companies.
338 As regards, first, the Commission’s alleged failure to take into account the gravity of the infringement, it is clear from the case-law of the Court of Justice that the gravity of infringements must be determined by reference to numerous factors such as, in particular, the particular circumstances of the case, its context and the dissuasive element of fines, although no binding or exhaustive list of the criteria to be applied has been drawn up (order of 25 March 1996, SPO and Others v Commission, C‑137/95 P, EU:C:1996:130, paragraph 54; judgments of 17 July 1997, Ferriere Nord v Commission, C‑219/95 P, EU:C:1997:375, paragraph 33, and of 28 June 2005, Dansk Rørindustri and Others v Commission, C‑189/02 P, C‑202/02 P, C‑205/02 P to C‑208/02 P and C‑213/02 P, EU:C:2005:408, paragraph 241).
339 The factors capable of affecting the assessment of the gravity of the infringements include the conduct of each of the undertakings, the role played by each of them in the establishment of the agreement, decision or concerted practice, the profit which they were able to derive from it, their size, the value of the goods concerned and the threat that infringements of that type pose to the objectives of the European Union (judgments of 7 June 1983, Musique Diffusion française and Others v Commission, 100/80 to 103/80, EU:C:1983:158, paragraph 129; and of 28 June 2005, Dansk Rørindustri and Others v Commission, C‑189/02 P, C‑202/02 P, C‑205/02 P to C‑208/02 P and C‑213/02 P, EU:C:2005:408, paragraph 242).
340 In the light of the case-law cited in paragraph 339 above, the amount of the value transfer is a reliable indicator of the gravity of the infringement and the particular circumstances of the case. That amount is the result of negotiations in which the generic company participated (see paragraph 337 above) and reflects at the same time the conduct of that company, the role that it played in the infringement and the benefit that it gained from it, as well as the value of the goods concerned, as estimated by the parties to the agreement at issue.
341 As regards, secondly, the Commission’s alleged failure to take into account the duration of the infringement for the purpose of determining the amount of the fine, it should be noted that the fact that the Commission has not adjusted the amount of the value transfer to take account of the duration of the infringement does not justify the conclusion that it did not take that duration into account.
342 During the negotiations in which the amount of the value transfer to the generic company is determined, the parties necessarily take into consideration an estimate of the profits that that generic company could make, during the duration of the agreement at issue, if it entered the market (recital 1196 of the contested decision), and the profits that the originator company would be able to make, during the duration of the agreement at issue, from the exclusion of the generic company from the market.
343 In setting the amount of the value transfer, the parties to the agreement in question therefore take into account the period during which the generic company agrees not to compete with the originator company, that is to say the foreseeable duration of that agreement.
344 By using the amount of the value transfer received by the generic company as the amount of the fine, the Commission therefore takes into account the foreseeable duration, as estimated by the parties, of the generic company’s participation in the infringement.
345 It can therefore be concluded that the Commission takes the duration of the infringement into consideration indirectly, but sufficiently, on the basis of the amount of the value transfer received by the generic company.
346 In addition, it should be borne in mind that Lupin was not present on the market at issue at the time of the infringement, due to the very purpose of the Lupin agreement, which was a market exclusion agreement, and that it was therefore impossible for the Commission to use the value of sales made by the generic company on the market in question during the years in which the infringement took place as the amount of the fine.
347 It is the use of a method based on the annual value of the sales made by the undertaking concerned, as set out in the Guidelines on the method of setting fines, which then entails that, in order for the duration of the infringement to be duly taken into account, that annual value be multiplied by the number of years that undertaking participated in the infringement.
348 That calculation, or an equivalent calculation applying a coefficient proportional to the actual duration of the infringement, is irrelevant in the context of a method based on the value transfer received by the generic company, since the amount of that transfer, unlike the annual value of the sales of the undertaking concerned, already takes account of the — foreseeable — duration of the agreement at issue and therefore of the infringement.
349 Thus, the Commission was entitled to use, as the amount of the fine, the amount of the value transfer received by the generic company without it being necessary, or even appropriate, to take account of the duration of the infringement in another way.
350 It follows from the foregoing that, by using the amount of the value transfer as the amount of the fine, the Commission did not disregard the provisions of Article 23(3) of Regulation No 1/2003.
351 Moreover, the applicant cannot succeed in its argument that, in breach of the principle of equal treatment, it was penalised to a greater extent than the other generic companies, even though the contested decision did not find that its conduct was more blameworthy than that of the other generic companies, nor that the infringement that it committed lasted longer than that of those other companies. It follows from the foregoing considerations that both the gravity of the infringement and its duration, as well as the particular circumstances of the case, are adequately reflected in the amount of the value transfer. Consequently, these elements are also reflected in the amount of the fine imposed by the Commission.
352 The only concrete circumstance on which the applicant relies in that respect, namely the fact that the duration of the infringement committed by Lupin was less than that of the infringements committed, respectively, by Niche and Unichem, by Teva and by Krka, does not support the conclusion that the Commission did not fulfil its duty to assess the facts of each case in order to set the amount of fines at an appropriate level.
353 In any event, a comparison between Lupin’s situation and that of Krka has already been carried out in the context of the second plea relating to the fine, in respect of which the Court has affirmed the Commission’s approach (see paragraph 293 et seq. above).
354 As regards the comparison between Lupin’s situation and that of Niche, Unichem and Teva, it must be found — given the specific features of the Lupin agreement and the increased gravity which results from those specific features (see paragraph 363 below) — that the amount of the fine imposed on Lupin could, in any event, be greater than that imposed on the generic companies that did not conclude side deals, even though its conduct was otherwise no more reprehensible than that of the other generic companies and the duration of the infringement committed by Lupin was less than that of the infringements committed by those companies.
355 It follows from all of the foregoing that the present plea must be rejected.
4. The failure to take into account the legitimacy of the value transfer
(a) Arguments of the parties
356 According to the applicant, the patent applications granted by Lupin to Servier had a certain value and the Commission could not ignore that value when setting the amount of the fine.
357 The applicant alleges, inter alia, that the Commission failed to determine what a reasonable value would have been for the patent applications.
358 The applicant asks the Court to determine a new amount by deducting the value of the patent applications from the amount of the fine set by the Commission. It proposes various methods of evaluation in that regard.
359 The applicant also states that there is no logical link between deducting the value of the patent applications at issue from the amount of the fine and the deterrent effect of the fine.
360 The Commission points out that, in addition to the payment of EUR 40 million to the applicant, Servier granted the applicant a royalty-free licence on the patent applications.
361 The Commission also states that, in so far as it had established the anticompetitive nature of the settlement, it was not required, for the purpose of setting the fine, to reach a conclusion as to what a reasonable market value of Lupin’s patent applications would actually have been under normal competition conditions.
(b) Findings of the Court
362 The applicant submits that the Commission erred in using the entirety of the value transfer received by applicant under the assignment agreement for the purpose of determining the amount of the fine. The applicant submits, in particular, that the Commission should have deducted the ‘legitimate’ value of the three patent applications transferred by Lupin to Servier from the amount of the fine.
363 However, an infringement of competition law committed through the use, via a side deal, of a method designed to hide the existence of that infringement (see paragraphs 384 and 385 below) is a particularly serious infringement, by its very nature (see, to that effect, judgment of 9 July 2009, Peugeot and Peugeot Nederland v Commission, T‑450/05, EU:T:2009:262, paragraph 284), which may justify taking into account the amount of the value transfer received by that generic company without deducting from that amount the quid pro quo which that company would have received from a transaction carried out at arm’s length.
364 In addition, the purpose of a fine is not simply to remove the benefits that an undertaking has obtained through its anticompetitive conduct, but also, as is apparent from point 4 of the Guidelines on the method of setting fines, to deter that undertaking and other undertakings from engaging in such conduct (see, to that effect, judgment of 8 September 2016, Xellia Pharmaceuticals and Alpharma v Commission, T‑471/13, not published, under appeal, EU:T:2016:460, paragraph 429). If the purpose of the fine were to be confined merely to negating the expected profit or advantage, insufficient account would be taken of the fact that the conduct in question constitutes an infringement of Article 101(1) TFEU and the punitive nature of the fine in relation to the actual infringement committed (judgment of 27 September 2006, Archer Daniels Midland v Commission, T‑329/01, EU:T:2006:268, paragraph 141).
365 If the amount of the fine had to be set by subtracting the ‘legitimate’ part of that transfer – to use the expression employed by the applicant, that is to say the part corresponding to the quid pro quo that would have resulted from a transaction carried out at arm’s length — from the total amount of the value transfer, the effect of the fine would be merely to annul the benefit gained from the infringement, which would limit its dissuasive nature.
366 Accordingly, it is not necessary to reduce the amount of the fine by subtracting the ‘legitimate’ part of the value transfer from the total amount, regardless of the method proposed by the applicant to determine the ‘legitimate’ value of the patent applications transferred by Lupin to Servier.
367 It should also be stated that, even if only the development costs of the patent applications in question were deducted from the total amount of the value transfer and therefore from the amount of the fine, the deterrent effect of that fine would be reduced because the generic company concerned would then be assured that, if it commits an offence, it will not suffer a loss or, at most, it will suffer only a limited loss.
368 The applicant’s submission in the reply that the Commission should have deducted the ‘legitimate’ value of the patent applications from the basic amount of the fine and subsequently increased that basic amount so as to ensure that the fine was dissuasive is not convincing and, moreover, it was not necessary for the Commission to do so.
369 Thus, where a generic company has been induced, by a side deal, to abandon its competitive efforts, the Commission is not required — when determining the extent of the inducive benefit for the purpose of calculating the fine (see paragraph 190 above) — to deduct from the total amount of the value transfer received by the generic company either the part of that amount corresponding to the quid pro quo that would have resulted from a transaction carried out at arm’s length (see paragraph 366 above) or any costs incurred in developing the asset transferred (see paragraph 367 above).
370 However, it cannot be ruled out that a breach of the principle of proportionality may arise where the Commission relies on the total amount of the value transfer received by the generic company to reflect the reverse payment that it received and the Commission thus sets the fine at an amount equivalent to the total amount of the value transfer.
371 In that respect, it should be noted that, in the specific context of side deals, the reverse payment corresponds to the part of the payment made by the originator company which exceeds the ‘normal’ value of the asset traded (see paragraphs 168 to 170 above).
372 Thus, where, in a side deal, the generic company transfers ownership of an asset to the originator company, the generic company’s capital is reduced by an amount equivalent to the ‘normal’ value of that asset. In that case the reverse payment does not correspond to the entire value transfer received by the generic company, merely to the part of that transfer which exceeds that ‘normal’ value.
373 In the event that the reverse payment represents only a very small part of the total amount of the value transfer received by the generic company, since the majority of the transfer corresponds to the ‘normal’ value of the asset transferred to the originator company, it cannot be ruled out that, by using the total amount of the value transfer received by the generic company as the amount of the fine, the Commission would impose a disproportionate fine on that company.
374 Furthermore, in such a case, the total amount of the value transfer received by the generic company would no longer be capable of accurately reflecting the reverse payment made to it. That amount therefore would not enable the gravity and the duration of the infringement to be adequately taken into account (see paragraphs 337 to 355 above).
375 The Commission can therefore rely on the total amount of the value transfer received by the generic company to reflect the reverse payment made to it and impose a fine of an equivalent amount on that company only where that amount does not appear to be out of proportion to the amount of the reverse payment.
376 However, the Commission cannot be required — in order to assess whether there is a disproportion such as that mentioned in paragraph 375 above — to distinguish, in all circumstances, within the value transfer in question, between, on the one hand, the inducive reverse payment and, on the other hand, the ‘legitimate’ payment corresponding to the normal value of the asset traded, and to determine their respective amounts precisely.
377 First, the Commission does not always have access to all the relevant factors to determine the ‘exact’ value of the asset traded.
378 For example, in the present case, Lupin did not provide an estimate of the total cost of its perindopril development programme (recital 1962 of the contested decision) and Servier did not provide any documents contemporaneous with the assignment agreement capable of shedding light on the amount of savings expected from the acquisition of Lupin’s technology (recital 1964 of the contested decision).
379 Although the Commission has extensive powers of investigation under Regulation No 1/2003, it may be faced with an absence of contemporaneous documents enabling it to determine the precise value of the asset traded.
380 In that case, the Commission’s calculation will depend on evaluations made after the acquisition in question provided to it by the parties to the agreement at issue for the purpose of the proceedings concerning them. The parties to that agreement will have an interest in increasing the value of the transferred asset in order to reduce accordingly the amount of the reverse payment.
381 Secondly, where a technology assignment agreement is at issue, as in the present case, it is not easy for the Commission to demonstrate that that technology was not purchased at arm’s length (see paragraph 170 above), that is to say at a price higher than the market price. In most cases, there are no exactly equivalent transactions.
382 Added to this is the fact that, in the field of technology, it is not unusual for the purchase price of a technology to exceed considerably the development costs of that technology, with the acquirer betting that the future income from that technology will be enough to compensate for the high cost of acquisition.
383 Thus, it is not always possible to establish an ‘exact’ or ‘objective’ evaluation of a technology.
384 It must be noted that, given the autonomous nature of a side deal (see paragraph 164 above), parties that wish to be wholly free to determine the terms of such an agreement and, in particular, the value transfers involved are able to do so. They have only then to ensure that that agreement and the settlement agreement are effectively independent.
385 Thus, a side deal results from the choice of the originator company and the generic company to connect two agreements which are in principle autonomous and thus to create an artificial link between those agreements capable of masking illegitimate value transfers which are difficult for the Commission to verify.
386 It follows from the foregoing that, where the parties to a settlement agreement containing restrictive clauses decide to link that agreement to a technology assignment agreement which is a vehicle for a transfer of value from the originator company to the generic company and it is found that that value transfer is inducive, and the settlement agreement thus constitutes a market exclusion agreement, the Commission must — in light of the elements that it is able to access, given, in particular, its extensive powers of investigation under Regulation No 1/2003 (see paragraph 379 above) — merely ensure that the total amount of the value transfer is not out of proportion to the amount of the reverse payment.
387 However, the generic company may also, if it believes that it is well founded, establish, by adducing all evidence to that effect, that the reverse payment made to it is considerably less that the total amount of the value transfer that it received, with the result that that amount is not capable of accurately reflecting that reverse payment and, accordingly, the gravity and the duration of the infringement.
388 In the present case, the Commission assessed the value, for Lupin, of the patent applications that the latter had transferred to Servier by using an approach based, first, on the development costs and, secondly, on the expected income (recital 1962, 1963, 1964 and 1974 of the contested decision).
389 With regard to the costs-based approach, the Commission found that Lupin had been unable to provide an estimate of the total cost of its perindopril development programme. In order to evaluate that cost, the Commission referred to the perindopril development programme of another generic company, considering that the cost incurred by the latter could not have been less than that incurred by Lupin (recital 1962 of the contested decision).
390 The wording of the contested decision in that respect, in particular the vocabulary used by the Commission (such as the expressions ‘unlikely’ or ‘it is safe to assume’), and, more generally, the caution evident in its findings show the difficulties that it encountered in assessing the exact value of Lupin’s patent applications.
391 However, the costs-based evaluation of the value of Lupin’s technology allowed the Commission to find a particularly significant reverse payment which was therefore enough to consider that the total amount of the value transfer, namely EUR 40 million, did not appear disproportionate (recital 1962 of the contested decision).
392 As regards the evaluation of Lupin’s patent applications on the basis of its profit expectations, the Commission necessarily relied on documents of a prospective nature. The certainty of the resulting evaluation is therefore limited. In addition, the documents in question are ‘strategy’ documents (recital 1974 of the contested decision) and it is therefore difficult to know the objective pursued by their author, which could have been, amongst other things, to convince the readers of those documents of the merits of the proposed commercial or industrial policy. Those documents are therefore not particularly objective. In addition, some of the projections in those documents are based on the assumption, which was itself uncertain when the Lupin agreement was concluded, that the 947 patent was invalid (recital 1974 of the contested decision).
393 Nevertheless, the evaluation of the patent applications on the basis of those documents enabled the Commission to find a sufficiently large reverse payment that taking the total amount of the value transfer, namely EUR 40 million, into account for the purpose of setting the fine did not appear to be disproportionate. In that regard, it should be pointed out that, as the Commission rightly noted (recital 1974 of the contested decision), Lupin’s profit forecast concerned the first two to three years of marketing its product, that is to say the years during which it could expect to enjoy the highest margins before having to face increased competition from other generic companies. In addition, expected profits are, by nature, uncertain, unlike the payment of a sum of money, which may lead the owner of a technology to transfer it at a price less than that corresponding to the profits that it could expect to gain from its use. That may justify a decision by the Commission to take a low evaluation of the expected profits from the use of a technology for the purpose of determining the transfer value of that technology.
394 Thus, an evaluation of Lupin’s patent applications based on its profit expectations did not enable the Commission to conclude that the amount of the value transfer was disproportionate to the value of the reverse payment.
395 As for the assessment of the value of Lupin’s patent applications in the light of the value of that technology for Servier, that evaluation supported the finding of a particularly significant reverse payment. There was no evidence that Lupin’s technology enabled any substantial improvement of Servier’s production process. Nor was it disputed that, even four years after the acquisition of Lupin’s technology, Servier had not carried out any development of its production process based on that technology (recital 1964 of the contested decision).
396 It follows from the foregoing, taking into account the Commission’s evaluation of Lupin’s patent applications in the light of the evidence available to it, that the total amount of the value transfer received by Lupin was not out of proportion to the reverse payment made to it and therefore adequately reflected that payment. The Commission therefore did not err in considering, for the purpose of calculating the fine, that the total amount of the value transfer was equivalent to the reverse payment that Lupin had received.
397 It should also be added that the applicant, which bears the burden of proving before the Court that the amount of the fine imposed on it was disproportionate, has not adduced any evidence that could lead the Court to conclude that the reverse payment made to Lupin was significantly less than the total amount of the value transfer that it received, with the result that that amount could not adequately reflect that reverse payment (see paragraph 387 above).
398 In that respect, the applicant’s allegations that ‘those patent transfers had substantial value running to millions of euros’ are not supported by evidence and, in any event, do not support the conclusion that the amount of the value transfer received by Lupin, namely EUR 40 million, was disproportionate by comparison with the amount of the reverse payment.
399 It follows from the foregoing that the present plea in law must be dismissed and the applicant’s claim for annulment of the fine must be rejected.
400 Furthermore, in the light of all the considerations set out in the present judgment, in particular in paragraphs 362 to 399 above, it must be concluded that the amount of the fine imposed on Lupin is not disproportionate.
401 In that respect, it must be pointed out, in particular, that the Lupin agreement is a market exclusion agreement pursuing anticompetitive objectives. Such an agreement, which limits production (see paragraph 121 above), must — under point 23 of the Guidelines on the method of setting fines — in principle, be heavily fined.
402 There is therefore no need to reduce the amount of the fine, including by an amount that would be less than the development costs of the patents at issue (see paragraph 367 above).
403 Since none of the pleas in law relied on by the applicant in support of its application for annulment of the contested decision is well founded or effective and since the examination of the arguments put forward in support of its application for reduction of the amount of the fine has not revealed any inappropriate elements in the Commission’s calculation of that amount, the action must be dismissed in its entirety.
Costs
404 Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since Lupin has been unsuccessful, it must be ordered to pay the costs, in accordance with the form of order sought by the Commission.
On those grounds,
THE GENERAL COURT (Ninth Chamber)
hereby:
1. Dismisses the action;
2. Orders Lupin Ltd to pay the costs.
Gervasoni | Madise | da Silva Passos |
Delivered in open court in Luxembourg on 12 December 2018.
E. Coulon | S. Gervasoni |
Registrar | President |
Table of contents
I. Background to the dispute
A. Perindopril
1. The compound patent
2. Secondary patents
B. The applicant
C. Disputes relating to perindopril
1. Disputes before the EPO
2. Disputes before the national courts
(a) Dispute between Servier and Krka
(b) Dispute between Servier and Lupin
(c) Dispute between Servier and Apotex
D. Patent dispute settlements
E. The Sector Inquiry
F. The administrative procedure
Procedure and forms of order sought
II. Law
A. The claim for annulment of the contested decision
1. The erroneous finding of a restriction of competition by object
(a) Arguments of the parties
(b) Findings of the Court
(1) Error of law
(i) Restrictions of competition by object
(ii) Intellectual property rights and, in particular, patents
(iii) Patent dispute settlements
(iv) The reconciliation of patent settlement agreements and competition law
(2) The absence of infringement
(i) The absence of an inducive benefit
(ii) The absence of a limitation of the generic company’s efforts to compete with the originator company
(iii) The absence of infringement
(3) The criticisms concerning the Commission’s definition of the scope of the infringement
2. The erroneous finding of a restriction of competition by effect
(a) Arguments of the parties
(b) Findings of the Court
B. Objection to the fine and its amount
1. Novelty of the infringement
(a) Arguments of the parties
(b) Findings of the Court
2. The difference in treatment between Lupin and Krka
(a) Arguments of the parties
(b) Findings of the Court
3. The application of a method of calculating the fine that did not take into account the gravity and the duration of the infringement
(a) Arguments of the parties
(b) Findings of the Court
4. The failure to take into account the legitimacy of the value transfer
(a) Arguments of the parties
(b) Findings of the Court
Costs
* Language of the case: English.
© European Union
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