Source: EURLEX
Language: en
Format: md

JUDGMENT OF THE GENERAL COURT (Ninth Chamber)

12 December 2018 ([\*](#Footnote*))

(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 — Potential competition — Restriction of competition by object — Balance between competition law and patent law — Imputation of the unlawful conduct — Fines)

In Case T‑682/14,

**Mylan Laboratories Ltd,** established in Hyderabad (India),

**Mylan, Inc.,** established in Canonsburg, Pennsylvania (United States),

represented by S. Kon, C. Firth and C. Humpe, Solicitors,

applicants,

v

**European Commission,** represented initially by F. Castilla Contreras, T. Vecchi, and B. Mongin and subsequently by F. Castilla Contreras, B. Mongin and C. Vollrath, acting as Agents, and by S. Kingston, Barrister-at-law,

defendant,

APPLICATION under Article 263 TFEU for annulment of Commission Decision C(2014) 4955 final of 9 July 2014 relating to a proceeding under Article 101 and Article 102 TFEU [Case AT.39612 — Perindopril (Servier)] in so far as it concerns the applicants and, in the alternative, for annulment or reduction of the fine imposed on the applicants 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 27 June 2017,

gives the following

Judgment

**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, ‘the 658 patent’) was filed with the European Patent Office (EPO) on 29 September 1981. The 658 patent was due to expire on 29 September 2001, but protection was prolonged in a number of EU Member States, including the United Kingdom, until 22 June 2003, in accordance with Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ 1992 L 182, p. 1). In France, protection under the 658 patent was prolonged until 22 March 2005 and, in Italy, until 13 February 2009.

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, EP0308341 (respectively, ‘the 339 patent’, ‘the 340 patent’ and ‘the 341 patent’) and EP0309324.

5        Servier filed new patents relating to erbumine and its manufacturing processes with the EPO between 2001 and 2005, 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’). 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.

3.      **Second generation perindopril**

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

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

B.      **The applicants**

8        Matrix Laboratories Ltd (‘Matrix’) is an Indian company which primarily develops, produces and markets APIs for generic companies.

9        Following a number of shareholding acquisitions, including the acquisition of a majority shareholding on 8 January 2007, the second applicant, Mylan Inc., has held between 97 and 98% of Matrix’s capital since 2011. Matrix has been known as Mylan Laboratories Ltd, the name of the first applicant, since 5 October 2011.

C.      **The applicants’ perindopril activities**

10      On 20 May 2003, Matrix merged with Medicorp Technologies India Ltd (‘Medicorp’), which, on 26 March 2001, concluded a development and licensing agreement with another company, of which Niche Generics Ltd (‘Niche’) was the successor, with a view to marketing a generic version of perindopril (‘the Niche/Matrix agreement’). An amendment to that agreement, concluded on 30 March 2004, provided that Matrix was to take over all of Medicorp’s responsibilities and obligations under the Niche/Matrix agreement. Under that agreement, the two companies were to market generic perindopril in the European Union, with Matrix responsible primarily for developing and supplying perindopril’s API, while Niche was responsible primarily for taking the necessary steps to obtain marketing authorisations and for the business strategy.

11      On 27 March 2003, Medicorp had also concluded an agreement for the development and manufacture of perindopril tablets with Niche’s parent company, Unichem Laboratories Ltd (‘Unichem’), under which Medicorp would undertake to develop perindopril’s API and to provide it to Unichem, which was responsible for the production of perindopril in final dosage form. The amendment to that agreement, concluded on 12 April 2004, provided that Matrix was to take over all of Medicorp’s responsibilities and obligations under the agreement.

D.      **Disputes relating to perindopril**

1.      **Dispute before the EPO**

12      In 2004, 10 generic companies filed opposition proceedings against the 947 patent before the EPO seeking the revocation of that patent on grounds of lack of novelty, lack of inventive step and insufficient disclosure of the invention.

13      On 27 July 2006, the Opposition Division of the EPO confirmed the validity of the 947 patent after Servier made some minor amendments to its original claims. Seven companies brought an appeal against that decision. 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**

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

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

15      On 25 June 2004, Servier brought an action for infringement before the High Court of Justice (England & Wales), Chancery Division (Patents Court), against Niche, in relation to the 339, 340 and 341 patents, after Niche applied for marketing authorisations in the United Kingdom for the generic version of perindopril, developed in partnership with Matrix (see paragraph 10 above). On 9 July 2004 Niche served on Servier a counterclaim for a declaration of invalidity of the 947 patent.

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

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

(b)    **Dispute between Servier and Apotex**

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

E.      **The agreement concluded between Matrix and Servier**

19      Servier entered into a series of settlement agreements with a number of generic companies with which it was involved in patent disputes.

20      On 8 February 2005, Servier concluded a settlement agreement (‘the Agreement’) with Matrix. The territorial scope of the Agreement covered all the countries in which the 339, 340, 341 and 947 patents existed, with the exception of one of them (Section 1(1)(xiii) of the Agreement).

21      Under that agreement, Matrix committed to refrain from making, having made, keeping, importing, supplying, offering to supply or disposing of perindopril made using the process developed with Niche and which Servier considered as infringing the 339, 340 and 341 patents, as validated in the United Kingdom, using a substantially similar process or using any other process that would infringe the 339, 340 and 341 patents (‘the process at issue’) until the local expiry date of those patents (Clauses 1 and 2 of the Agreement) (‘the non-marketing clause’). However, the Agreement stipulated that Matrix would be free to deal in perindopril made using the process at issue without infringing the patents after the expiry of those patents (Clause 4 of the Agreement). Moreover, Matrix was required to cancel, terminate or suspend until the expiry date of the patents all of its existing contracts relating to perindopril made using the process at issue and to marketing authorisation applications for that perindopril by 30 June 2005 at the latest (Clauses 7 and 8 of the Agreement). Furthermore, it committed not to apply for marketing authorisations for perindopril made using the process at issue and not to assist any third parties to obtain such a marketing authorisation (Clause 6 of the Agreement). Finally, Matrix was to abstain from any invalidity and non-infringement actions against the 339, 340, 341, 947, EP1294689 and EP1296948 patents until their expiry, except as a defence to a patent infringement action (Clause 5 of the Agreement) (‘the non-challenge clause’).

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

F.      **Developments after the conclusion of the Agreement**

23      In accordance with the Agreement, in a letter sent to Niche dated 22 June 2005, Matrix declared that the Niche/Matrix agreement was to be suspended with immediate effect until the expiry of the 339, 340 and 341 patents in 2008.

24      Also in June 2005, Matrix acquired a company which has marketed a generic version of Servier’s perindopril in Belgium since September 2009 and another company which started to market perindopril in the Netherlands in November 2008 on the basis of a licensing and supply agreement for perindopril concluded with Krka Tovarna Zdravil d.d. Matrix has not owned these subsidiaries since September 2010.

25      A number of companies belonging to the Mylan group also started to market generic versions of perindopril purchased from Servier in Belgium, France, the Netherlands and the United Kingdom between 2007 and the end of 2009.

G.      **The Sector Inquiry**

26      On 15 January 2008, the Commission 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.

27      The Commission published a preliminary report on the results of its inquiry on 28 November 2008 as a basis for 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.

H.      **The administrative procedure and the contested decision**

28      On 24 November 2008, the Commission carried out unannounced inspections at the premises of the companies concerned. The Commission sent requests for information to several companies, including the applicants, in January 2009.

29      On 2 July 2009 the Commission decided to open proceedings against Servier and certain generic companies involved. It formally opened proceedings against Mylan on 27 July 2009.

30      In August 2009 and then between December 2009 and May 2012, the Commission sent new requests for information to the applicants. Between 2009 and 2012, the applicants were invited to attend a number of state of play meetings.

31      On 27 July 2012, the Commission issued a Statement of Objections to several companies including the applicants, which submitted their reply on 12 December 2012.

32      Following the hearing held on 15 to 18 April 2013 and attended by the companies concerned, further state of play meetings were arranged and additional requests for information sent.

33      On 18 December 2013, the Commission granted access to evidence gathered or more widely disclosed after the Statement of Objections and sent a Letter of Facts to which the applicants replied on 17 January 2014. On 4 April 2014, the Commission also sent Letters of Facts concerning solely the issue of parental liability to Mylan and Matrix in particular, to which they replied on 2 May 2014.

34      The Hearing Officer issued his final report on 7 July 2014.

35      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’).

36      Under Article 2 of the contested decision, the applicants infringed Article 101 TFEU by participating in a reverse payment patent dispute settlement agreement covering all Member States, except Croatia and Italy, for the period starting 8 February 2005, with regard to Mylan Laboratories, and for the period starting 8 January 2007, with regard to Mylan, except as regards Latvia (period starting 1 July 2005), Bulgaria and Romania (period starting 1 January 2007) and Malta (period starting 1 March 2007) and ending on 15 September 2008, except as regards the Netherlands (period ending 1 March 2007) and the United Kingdom (period ending 6 July 2007).

37      The Commission imposed on Mylan Laboratories a fine in the amount of EUR 17 161 140, of which EUR 8 045 914 jointly and severally with Mylan (Article 7(2) of the contested decision). The applicants are also 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).

II.    **Procedure and forms of order sought**

38      By application lodged at the Court Registry on 19 September 2014, the applicants brought the present action.

39      Acting upon a proposal of the Judge-Rapporteur, the Court decided to open the oral part of the procedure and, in the context of the measures of organisation of procedure laid down in Article 89(3)(a) of the Rules of Procedure of the General Court, put written questions to the parties, requesting them to answer those questions at the hearing.

40      At the hearing on 27 June 2017, the parties presented oral argument and their answers to the written and oral questions put by the Court.

41      The applicants claim that the Court should:

–        annul Articles 2, 7 and 8 of the contested decision in so far as they concern them;

–        in the alternative, annul Article 7 of the contested decision in so far as it imposes a fine on them;

–        in the further alternative, reduce the amount of the fine imposed on them;

–        in the final alternative, annul Articles 2, 7 and 8 of the contested decision in so far as they concern Mylan;

–        order the Commission to pay the costs.

42      The Commission contends that the Court should:

–        dismiss the application;

–        order the applicants to pay the costs.

III. **Law**

A.      **The claim for annulment of Articles 2, 7 and 8 of the contested decision in so far as they concern the applicants**

1.      **The plea alleging errors of law and of assessment in the analysis of potential competition on the market**

(a)    **The criteria for assessing potential competition**

(1)    *Arguments of the parties*

43      The applicants submit that the Commission applied an incorrect legal test in order to assess whether Matrix was a potential competitor to Servier. Rather than determining, in accordance with the case-law, whether there were real concrete possibilities of entering the market promptly using an economically viable strategy, the Commission considered that a company is a potential competitor if it has made efforts to develop the product in question, if the operator present on the market perceived that company to be a potential threat and if market entry, although difficult and remote, was not impossible.

44      In particular, the applicants note that the fact that efforts may have been made to overcome the regulatory, manufacturing or patent infringement-related barriers does not mean that those efforts were likely to be successful and that there was a real concrete possibility of market entry. Similarly, the Commission incorrectly took account of the subjective perception of Servier, which, as an originator company, feared the competition of many generic companies, whereas the assessment of potential competition must be objective. It also deprived of its substance the requirement of a sufficiently quick market entry, taking the view that the delays in the development of a product were the sign of competitive pressure exerted over a longer period.

45      The Commission contends that it has complied with the settled case-law according to which the main test in assessing potential competition is to ascertain whether, in the light of the structure of the market and the economic and legal context within which it functions, there are real concrete possibilities for the undertakings concerned to compete on the market. It adds that, on the basis of the analysis of the existing evidence, including, in particular, the advanced research and the steps to obtain marketing authorisations, it was able to conclude that ‘Matrix/Niche’ had the ability and intention to enter the EU market with its generic perindopril within a short period of time and, therefore, formed a real competitive threat to Servier, as Servier and other generic companies had already acknowledged.

(2)    *Findings of the Court*

46      It should be noted that, according to settled case-law, also cited by the applicants, an undertaking is a potential competitor if there are real concrete possibilities for it to enter the market in question and compete with established undertakings. Such a demonstration must not be based on a mere hypothesis, but must be supported by evidence or an analysis of the structures of the relevant market. Accordingly, an undertaking cannot be described as a potential competitor if its entry into a market is not an economically viable strategy (judgment of 29 June 2012, *E.ON Ruhrgas and E.ON* v *Commission*, T‑360/09, EU:T:2012:332, paragraph 86; see also, to that effect, judgment of 14 April 2011, *Visa Europe and Visa International Service* v *Commission*, T‑461/07, EU:T:2011:181, paragraphs 166 and 167 and the case-law cited). It necessarily follows that, while the intention of an undertaking to enter a market may be of relevance in order to determine whether it can be considered to be a potential competitor in that market, nonetheless the essential factor on which such a description must be based is whether it has the ability to enter that market (judgments of 14 April 2011, *Visa Europe and Visa International Service* v *Commission*, T‑461/07, EU:T:2011:181, paragraph 168; of 29 June 2012, *E.ON Ruhrgas and E.ON* v *Commission*, T‑360/09, EU:T:2012:332, paragraph 87; and judgment delivered today, *Servier and Others* v *Commission*, T‑691/14, paragraph 318 to 321).

47      Contrary to the applicants’ assertions, in the present case the Commission did not apply any criteria for assessing potential competition which were not consistent with the criterion of real concrete possibilities for market entry, as established in the case-law mentioned in paragraph 46 above.

48      First, the Commission did not apply the criterion of the lack of insurmountable barriers to market entry, which, as the applicants rightly submit, implies that any possibility — even hypothetical — of market entry is sufficient to establish the existence of potential competition, and thus differs from the real concrete possibilities criterion, in particular as regards the threshold for a finding of potential competition.

49      Although the Commission referred to the insurmountable barriers criterion several times in the contested decision (see inter alia recitals 1125 and 1181) and to the judgment of 21 May 2014, *Toshiba* v *Commission* (T‑519/09, not published, EU:T:2014:263), which applied that criterion, it also referred to the judgments of 15 September 1998, *European Night Services and Others* v *Commission* (T‑374/94, T‑375/94, T‑384/94 and T‑388/94, EU:T:1998:198); of 14 April 2011, *Visa Europe and Visa International Service* v *Commission* (T‑461/07, EU:T:2011:181); and of 29 June 2012, *E.ON Ruhrgas and E.ON* v *Commission* (T‑360/09, EU:T:2012:332), which applied the real concrete possibilities criterion, and also mentioned some of those judgments in the introduction to its presentation of the rules for determining potential competitors (recitals 1156 and 1157 of the contested decision).

50      The Commission also clearly indicated that the ability to enter a market, which is a characteristic of the real concrete possibilities criterion (see paragraph 46 above), remained ‘the crucial aspect in demonstrating potential competition’ (recital 1163 of the contested decision). Lastly, and above all, in its assessment of each of the generic companies in question as a potential competitor, the Commission concluded — on the basis of several pieces of information specific to each of them, concerning inter alia their production capacities and their stocks of products, their commercial contracts, the steps they had taken to obtain marketing authorisations and their litigation against Servier — that all of them had real concrete possibilities of entering the market. Such a detailed analysis on the basis of information specific to each alleged potential competitor is characteristic of the examination of its real concrete possibilities of entering the market and is not the same as merely checking whether there are insurmountable barriers to entry on a given market, which could result in a finding of potential competition simply because any operator entered the market in question.

51      It should be noted, moreover, that the applicants themselves acknowledged that the Commission also applied other criteria, including that of efforts to develop a generic product (see paragraph 43 above).

52      Secondly, it must be held, in that regard, that, contrary to the applicants’ assertions, that criterion of efforts to develop a generic product, as set out and applied in the contested decision, is consistent with the criterion of real concrete possibilities of market entry.

53      Efforts to develop a generic product, which the Commission specifies as concerning the manufacture of the product, compliance with the originator undertaking’s patents and the obtention of a marketing authorisation (see inter alia recitals 1125 and 1181 of the contested decision), clearly show an intention to enter the market. They are also indicative of an ability to enter the market, since they involve active steps taken to produce and market the generic medicinal product and since, as regards steps which have not yet been completed, such as an ongoing marketing authorisation procedure, they are taken into account, as the Commission states (see inter alia recital 1181 of the contested decision), only if they do not face insurmountable problems and therefore have a chance of succeeding. It should be pointed out, in that respect, that the Commission’s use of the insurmountable problems criterion in its analysis does not amount to basing that analysis on that criterion alone, but rather is intended solely and appropriately, for the purposes of establishing the real and concrete nature of the possibilities in question, to supplement the examination of the ability to obtain the marketing authorisation applied for based on the steps completed by the applicant.

54      Moreover, contrary to the applicants’ assertions, it is irrelevant (see paragraph 44 above) whether the efforts in question were ultimately successful. To take into account only efforts which were successful, and thus enabled market entry, at the time of assessing potential competition would amount to denying the distinction between potential competition, which implies an absence of market entry, and actual competition, which implies that that entry has taken place (see, to that effect, judgment of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraph 159). It must also be borne in mind that the mere existence of an undertaking outside the market with the ability to enter it may, in certain cases, give rise to competitive pressure on the undertakings currently operating in that market, a pressure represented by the likelihood that a new competitor will enter the market if the market becomes more attractive (judgment of 14 April 2011, *Visa Europe and Visa International Service* v *Commission*, T‑461/07, EU:T:2011:181, paragraph 169).

55      Thirdly, contrary to the applicants’ assertions, the analysis, from a temporal perspective, of potential competition carried out by the Commission in the contested decision is consistent with the applicable principles.

56      According to settled case-law cited by the Commission in the contested decision (recital 1158), an operator cannot be described as a potential competitor unless its potential entry could take place sufficiently quickly to form a constraint on market participants and thus exert competitive pressure on them (judgment of 14 April 2011, *Visa Europe and Visa International Service* v *Commission*, T‑461/07, EU:T:2011:181, paragraph 189; see also, to that effect, *E.ON Ruhrgas and E.ON* v *Commission*, T‑360/09, EU:T:2012:332, paragraph 114). That case-law refers to the Guidelines on the applicability of Article [101 TFEU] to horizontal co‑operation agreements (OJ 2001, C 3, p. 2; ‘the 2001 Guidelines on horizontal co‑operation agreements’) (see also the Guidelines on the applicability of Article 101 [TFEU] to horizontal co-operation agreements (OJ 2011, C 11, p. 1; ‘the 2011 Guidelines on horizontal co-operation agreements’)), which not only affirm the need for a sufficiently fast entry, but also set out indicative periods — of no more than one or three years, depending on the circumstances — that may constitute a sufficiently fast entry, on the basis on other guidelines as well as the Block Exemption Regulations.

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

58      In the present case, the Commission took into account the specific features of the economic and legal context of the present case by assessing the duration of each of the steps required in order to enter the market (recital 1182 and footnote 1669 to the contested decision). It should be pointed out that, precisely because of the particular features of the pharmaceutical sector and in particular the various steps that must be taken and the existence of patents, generic companies often begin their efforts to enter the market well before the expiry of the patents, in order to have completed the necessary steps by the time those patents expire at the latest. These efforts are therefore likely to exert competitive pressure on the originator undertaking, before, or even well before, the expiry of the patents and the actual market entry of the generic companies (see paragraph 105 below; see also, to that effect, judgments of 6 December 2012, *AstraZeneca* v *Commission*, C‑457/10 P, EU:C:2012:770, paragraph 108; of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraph 163; and of 8 September 2016, *Sun Pharmaceutical Industries and Ranbaxy (UK)* v *Commission*, T‑460/13, not published, under appeal, EU:T:2016:453, paragraphs 77 to 79).

59      Moreover, the Commission relied on the idea of competitive pressure inherent in potential competition in considering that any delays in the process of entering the market experienced by the generic companies were not sufficient by themselves to prevent those companies being regarded as potential competitors when they continued to exert such pressure due to their ability to enter the market and cited, to that effect, the judgment of 3 April 2003, *BaByliss* v *Commission* (T‑114/02, EU:T:2003:100). Contrary to the applicants’ submission, the Commission did not turn the requirement of sufficiently fast market entry ‘on its head’ by inferring from that judgment that delays that reflect complexities in the development of a product may suggest that the time frame over which competitive pressure may be exerted by a potential entrant is longer (recital 1159 of the contested decision). In so far as the delays concerned do not call into question the ability of the operator in question to enter the market and, more generally, its real concrete possibilities of entering the market, the Commission correctly considered that that operator exercises competitive pressure, in respect of which it should be borne in mind that such pressure may be exerted well before the market entry and thus during the efforts made to prepare for that entry (see paragraph 58 above). In that regard, it is irrelevant that that competitive pressure does not lead to a fall in prices, since such a fall in prices is not inherent in potential competition, but rather occurs as a result of a competitor entering the market and thus as a result of actual competition.

60      Fourthly, the criticism that the Commission took into account Servier’s subjective perception of Matrix as a potential competitor and disregarded the objective test of potential competition, namely whether there are real concrete possibilities of entering the market in question, cannot be accepted.

61      It is apparent from the contested decision that the Commission used the criterion of the incumbent’s perception, not as a key or decisive criterion, but as one of a number of criteria to determine whether the generic companies were potential competitors. In particular, it considered, in its presentation of the criteria for assessing potential competition, that, in order to ascertain whether the generic companies exerted competitive pressure on Servier, the perception of the incumbent, Servier, and that of other generic competitors would ‘also’ be taken into account (recital 1163 of the contested decision). Subsequently, in its assessment of the generic companies, including Matrix, as potential competitors, the Commission took account of Servier’s perception together with other elements showing Matrix’s ability and intention to enter the market and, moreover, that perception played only a very marginal role in comparison with the other elements (see paragraphs 77 to 83 below). Accordingly, it cannot therefore be maintained that, as the applicants submit, the Commission attributed more importance to Servier’s perception than to the generic companies’ intentions to enter the market in its analysis of potential competition.

62      In addition, contrary to the applicants’ assertions, the Commission did not intend to treat the criterion of the incumbent’s perception as anything other than an additional criterion of assessment by citing paragraph 169 of the judgment of 14 April 2011, *Visa Europe and Visa International Service* v *Commission* (T‑461/07, EU:T:2011:181), according to which, by its mere existence, an undertaking may give rise to competitive pressure represented by the likelihood that it will enter the market. That paragraph, as set out in essence in recital 1161 of the contested decision, follows inter alia paragraph 168 of that judgment which states that the essential factor on which the description of an undertaking as a potential competitor must be based is whether it has the ability to enter the market, which is also stated in essence in recital 1163 of the contested decision. Thus, the competitive pressure felt by the incumbent, referred to by the General Court and by the Commission in the contested decision, is that exerted by an undertaking with the ability to enter the market.

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

64      Contrary to the applicants’ assertions, the General Court clearly took account of the criterion of the incumbent’s perception in the judgment of 12 July 2011, *Hitachi and Others* v *Commission* (T‑112/07, EU:T:2011:342) in order to establish the existence of potential competition. It follows from paragraphs 90, 226 and 319 of that judgment, referred to in recital 1160 of the contested decision, that not only did the agreements at issue in that case between the European and Japanese producers constitute serious indicators that the Japanese producers were perceived by the European producers as credible potential competitors, they also showed that there were possibilities for the Japanese producers to penetrate the European market (see also, to that effect, judgment of 21 May 2014, *Toshiba* v *Commission*, T‑519/09, not published, EU:T:2014:263, paragraph 231). It is true that the General Court also carried out an objective analysis of the competitive situation, by examining inter alia the ability of the Japanese producers to enter the European market (judgment of 12 July 2011, *Hitachi and Others* v *Commission*, T‑112/07, EU:T:2011:342, paragraphs 157, 160 and 319 to 332), as, moreover, the Commission pointed out in recital 1160 of the contested decision. However, that objective analysis only serves to demonstrate that the subjective criterion of the incumbent’s perception is only one criterion among others for assessing the existence of potential competition.

65      It also follows from that case-law that, among the factors capable of demonstrating the incumbent’s perception that there is potential competition, the very fact that an undertaking already present on the market seeks to enter into agreements with undertakings with similar activities in the same sector but which are not present on that market, and a fortiori the conclusion of such agreements, is particularly strong evidence (see, to that effect, judgment of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraph 144). Thus, since the applicants do not dispute that such an agreement was concluded between Matrix and Servier, their allegation that some generic companies did not perceive Matrix as a potential competitor, even if it were proved, could not outweigh Servier’s perception of Matrix as a potential competitor, as indicated by the conclusion of the Agreement.

66      It follows from all the foregoing that the Commission did not apply any incorrect criteria for the assessment of potential competition in the present case.

(b)    **The allegedly incorrect assessment of Matrix as a potential competitor**

(1)    *Arguments of the parties*

(i)    *Matrix (alone) as a potential competitor*

67      The applicants submit that the Commission did not examine sufficiently whether Matrix, alone, was a potential competitor to Servier. As a mere API manufacturer based in India and with no presence in the European Union, with neither the ability to manufacture the end product, nor the know-how to carry out the regulatory procedure to obtain marketing authorisations, which is also not involved in a dispute concerning Servier’s patents, Matrix could not be considered to be a potential competitor to Servier.

68      In addition, the applicants, first, reject any analysis based on the potential competition of the product co-developed by Niche and Matrix, in view of the independence of both companies and the absence of an agreement between them to settle with Servier. The applicants refer in particular to several documents that demonstrate that Niche would have settled with Servier independently of Matrix, having regard, in particular, to Niche’s intention to withdraw from the project for the product co-developed with Matrix, and that Servier would have settled with Niche, independently of Matrix, as Servier had also claimed, in particular in view of its aggressive anti-generic strategy highlighted by the Commission in other parts of the contested decision. Furthermore, the applicants accuse the Commission of having, for the first time in its written pleadings, justified its combined analysis of the potential competition from Niche and Matrix by the fact that a separate analysis risked undermining the effectiveness of Article 101 TFEU.

69      The applicants add, secondly, that the issue, analysed by the Commission in the part of the contested decision regarding the anticompetitive effects of the Agreement, of whether Matrix would have been able to find an alternative partner to Niche and with that partner form a significant threat to Servier is irrelevant for the purposes of assessing its status as a potential competitor.

70      According to the applicants, in addition and in any event, the Commission has not demonstrated that Matrix, at such an advanced stage in the attempts to market the generic perindopril, would have been able to find a partner to replace Niche. The Commission failed to consider a number of factors which show that Matrix would not have been able to find an alternative partner to develop perindopril. The applicants refer, in that regard, to Servier’s anti-generic strategy, which is also mentioned in the contested decision, and its intention to remove Matrix, inter alia by purchasing its API technology, which would have dissuaded Matrix’s potential partners, the technical barriers to the manufacture of perindopril related to the issues that arose with Matrix’s API and the regulatory barriers related to the preparation of the marketing authorisation dossier, and the significant uncertainty any potential partner would have faced as a result of the patent position, which entailed the very likely prospect of future litigation with Servier. The applicants add that the Commission wrongly considered that the acquisition by Matrix of two companies established in the European Union demonstrates that Matrix could have entered into a relationship with those companies to market perindopril, since that acquisition took place after the conclusion of the Agreement and the two companies in question did not have the capacity to turn the API into an end product. Moreover, contrary to the Commission’s view, Teva, which had envisaged a partnership with Niche only, could not be regarded as a potential partner for Matrix.

71      The Commission contends that the argument alleging that it was required to prove that Matrix, acting alone, would have been a potential competitor, has no legal or economic basis in a situation where Niche and Matrix were engaged in a joint project which aimed to develop and launch a competing product to Servier’s. It submits, in response to the applicants’ arguments, that the analysis of potential competition proposed by the applicants would seriously compromise the effectiveness of Article 101 TFEU, particularly in the pharmaceutical sector in which medicines often come to market through partnerships.

72      The Commission adds, first, that, in the present case, Matrix was, in any event, a potential competitor to Servier, independently of Niche. In that regard, it relies on the clauses of the Niche/Matrix agreement that provide for the possibility of Matrix marketing perindopril directly, Servier’s subsequent insistence on concluding an agreement with Matrix, which it perceived to be a potential competitor, and the fact that Matrix was not dependent upon Niche to find a route to market and, on its own initiative, terminated the Niche/Matrix agreement.

73      The Commission explains, secondly, that its thorough examination in the contested decision of the various factors which the applicants allege were not taken into account enabled it to determine that Matrix could have found a partner to replace Niche. Accordingly, it is clear from the documents in the file that other generic companies were very interested in marketing generic perindopril and Servier’s alleged intention to purchase Matrix’s API technology is merely an illustration of the competitive threat posed by the API suppliers. Moreover, Matrix worked to resolve any technical issues that arose and could have received assistance from Niche, as provided for in the event of termination of the Niche/Matrix agreement. Furthermore, according to the Commission, there was no need to submit a new marketing authorisation application. Finally, the Commission relies on the belief of Niche and Matrix that the action for infringement brought by Servier based on the 339, 340 and 341 patents would be rejected and that the 947 patent would be declared invalid, in order to exclude the relevance, in the present case, of the patent litigation. The acquisition of two companies by Matrix confirms Matrix’s continued interest in marketing perindopril and its ability to do so. The Commission submits that Teva had the capacity to assume the commitments of the partnership previously guaranteed by Niche and had initiated discussions with a view to concluding an agreement with Matrix.

(ii) *Matrix (with Niche) as a potential competitor*

74      The applicants submit, in the alternative, that the Commission has not demonstrated sufficiently that Matrix, with Niche, was a potential competitor to Servier. In particular, they criticise the Commission for not having given sufficient weight to the technical issues arising from the development of Matrix’s API, the regulatory position and Niche’s strategy to avoid infringing Servier’s patents. They explain that those technical issues (reduced particle size of the API, presence of impurities, tablets were not as hard) resulted from a change in the manufacturing process of the product’s API by Matrix in order to avoid infringing Servier’s process patents (patents 339, 340 and 341), but which led to a risk of infringing the 947 patent, which Niche was unable to overcome, in view of its financial difficulties, by pursuing the litigation or by launching the product at risk. In that regard, the applicants criticise the Commission for having disregarded Servier’s patents which, although contested, were presumed to be valid since a decision settling that dispute had not been adopted and, in so doing, for having infringed 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’). They add that the technical issues encountered also undermined the prospect of obtaining a marketing authorisation and even led Niche to fear the worst case scenario that production needed to be started again. The applicants note, in that regard, that the UK regulatory authority had raised a number of issues which had to be addressed by Matrix and that the marketing authorisation granted to one of Niche’s customers was irrelevant, since it was not based on the new manufacturing process.

75      All of those issues, at the very least, delayed Matrix’s and Niche’s market entry considerably and the fact that they may have been actively trying to find solutions does not indicate whether solutions would have been found and whether they would have been found within a sufficiently short period of time.

76      The Commission contends that the issues in question do not constitute extremely serious obstacles and, even less so, insurmountable barriers to market entry, recalling the case-law in accordance with which a delay in the process of market entry is consistent with a finding of potential competition where the potential entrant exerts competitive pressure on the incumbent. It states, in particular, with regard to Servier’s patents, that the presumption of the validity of those patents did not mean that a generic company was precluded from entering the market, those patents did not create a ‘blocking position’ within the meaning of the 2004 Guidelines on technology transfer agreements and it is clear from the evidence that the existence of those patents did not constitute an absolute barrier to entry which would preclude all competition.

(2)    *Findings of the Court*

77      It should be borne in mind that, in the contested decision, the Commission considered that the development partners, Niche and Unichem, on one hand, and Matrix, on the other, were closely intertwined in their activities aimed at launching a generic version of perindopril on the market and that Matrix (with Niche and Unichem) was a prominent potential competitor of Servier that had the intention and the ability to enter the market within a short period of time (recitals 1421, 1427 and 1434), on the basis of the following five considerations.

78      First, the Commission noted that Niche, Unichem and Matrix had for several years invested resources in order to develop a product which could be launched as a generic alternative to Servier’s perindopril, and that venture was well progressed. That was shown, first, by the work towards obtaining marketing authorisations, which were expected to be obtained in 2005 and one of which had actually been obtained in the Netherlands by a customer of Niche in May 2005, and, secondly, by the commercial batches of API which were being prepared for the expected commercial launch and which Matrix regarded as sufficient to satisfy the anticipated orders (recital 1422 of the contested decision).

79      Secondly, the Commission pointed out that Niche had concluded 14 agreements with business partners that were keen on selling generic perindopril in Europe, which showed its belief that it would be able to market perindopril within a short period of time. It stated that, in October 2004, Niche had requested one of its customers to indicate its launch orders for 2005 in order to plan its production for 2005 and that, just a few days before the conclusion of the Agreement, it was negotiating a supply agreement with one of the largest generic companies (recital 1423 of the contested decision).

80      Thirdly, the Commission found that Servier itself considered that the cooperation between, on the one hand, Matrix — which was regarded as much more than ‘a simple supplier of the API’ — and, on the other hand, Niche and Unichem represented a ‘generic threat’, on the basis of, inter alia, due diligence which Servier had carried out with a view to acquiring Niche, and which highlighted the latter’s financial situation (recital 1424 and footnote 1966 of the contested decision).

81      Fourthly, the Commission referred to the patent litigation in which Niche — assisted by Matrix — had engaged. It pointed out, first, that Matrix had been informed about the litigation before the High Court of Justice (England & Wales), Chancery Division (Patents Court), and the EPO on a continuous basis and that it had, inter alia, provided witness statements to Niche for the purposes of that litigation and, secondly, that it was apparent from several statements made by Niche that the latter was confident that it would succeed in that litigation (recital 1425 of the contested decision).

82      Fifthly, the Commission emphasised that Matrix believed in the common project, which would have been economically viable, in view of the significant revenues it could have generated (recital 1426 of the contested decision).

83      Lastly, the Commission added, in reply to the various assertions made by Niche, Matrix and Servier during the administrative procedure, that a potential competitor did not have to have a readily marketable product, as long as it was able to enter the market within a short period of time and that it did not face difficulties which, taken together, would constitute insurmountable barriers. The absence of such difficulties in the present case was shown by the continuing cooperation between Niche and Matrix to resolve any outstanding problems (recitals 1428 to 1430 of the contested decision). As regards Matrix’s arguments that it did not have the capability to produce a final perindopril product, that it could not apply for a marketing authorisation since it was not established in the European Union, that the conclusion of an agreement with a marketing partner other than Niche was not a viable commercial option and that the competitive environment used to evaluate the potential competition was not appropriate, the Commission replied as follows in recital 1432 of the contested decision:

‘The assessment of potential competition between Servier and Matrix undertaken by the Commission is based on the product that was co-developed between Niche and Matrix which exercised a competitive threat on Servier at the time and resulted in the settlement agreement’s conclusion. In addition, the Commission has referred to the options that Matrix would have in the absence of the agreement both with and without the involvement of Niche (see [recital] (1493)) and has therefore not confused the relevant competitive environment contrary to what is claimed by Matrix. There are elements which enable to doubt that Servier would have settled only with Niche or that it would not have imposed obligations on Matrix’s behaviour through Niche. The negotiation of the Niche/Unichem settlement agreement is illustrative of Servier’s wish to subject the payments to Niche to the performance of obligations not to manufacture perindopril by Matrix ... It is evident that the source of the active ingredient which could also market the product had to be eliminated to prevent any entry sooner or later ... The documents cited at [recitals] (543) and (622) show that it would be irrational for Servier to settle with Niche without making sure that Matrix will be prevented from importing a product onto the UK market. In any event, the Commission has demonstrated that the settlement agreement covered the product co-developed by Niche and Matrix and that it was with this product that these companies were potential competitors of Servier. As to the absence of EU presence, the Commission notes that Matrix had acquired two companies based in the EU a few months following the settlement ... Although these companies are alleged by Matrix to have been primarily distribution businesses, these acquisitions show that Matrix could have looked for (and enter[ed] into a relationship with) an EU company looking to develop and commercialise the perindopril product. Hence the possibility to find an alternative EU partner was not as impossible as claimed, in particular if the termination clause of the development agreement between Niche and Matrix is taken into account (see footnote 2032). This clause allowed Matrix to gather certain data from Niche and, however limited this information could be, this clause would have permitted Matrix not to start the whole project anew.’

84      It follows that it was primarily Matrix with Niche, rather than Matrix alone, that the Commission assessed as a potential competitor.

85      The applicants criticise that assessment of Niche and Matrix, taken together, as a potential competitor, submitting that they are two autonomous companies and that there was no agreement between them to pursue a settlement with Servier (see paragraph 68 above).

86      That complaint cannot be maintained.

87      It should be borne in mind that a potential competitor is an undertaking that has real concrete possibilities of entering the market in question and that the essential factor on which that classification must be based is the ability of that undertaking to enter the market (see paragraph 46 above). That ability must be examined in the light of the facts of the case and the structures of the relevant market (see also paragraph 46 above), in particular the practice of using partnerships in order to access the market. The Court of Justice and the General Court have thus examined whether there are real concrete possibilities of entering a market by concluding agreements with partners (see, to that effect, judgments of 28 February 1991, *Delimitis*, C‑234/89, EU:C:1991:91, paragraph 21, and of 14 April 2011, *Visa Europe and Visa International Service* v *Commission*, T‑461/07, EU:T:2011:181, paragraphs 83 and 90 to 94) and the General Court has even criticised the Commission for failing to taken into account the capacity of a group which does not manufacture the product in question to enter the market through agreements with companies which manufacture that product (see, to that effect, judgment of 25 October 2002, *Tetra Laval* v *Commission*, T‑5/02, EU:T:2002:264, paragraph 331).

88      It follows that the classification of an undertaking as a potential competitor cannot be rejected merely because it is not able to enter a given market by itself, where it has the possibility of finding business partners through which it can access that market, or has already concluded an agreement with those business partners (see, to that effect, judgments of 14 April 2011, *Visa Europe and Visa International Service* v *Commission*, T‑461/07, EU:T:2011:181, paragraphs 82 and 83 and the case-law cited, and of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraphs 197 and 204). Contrary to the applicants’ arguments at the hearing in response to a question put to them by the Court in relation to that case-law, taking into consideration business partnerships in the assessment of potential competition does not amount to attributing an ability to enter the market to an operator which does not actually have such an ability, in order to subsequently penalise it despite its inability to enter the market. It is intended merely to take into account, as required by the case-law relating to the assessment of real concrete possibilities, the reality and the structure of the relevant market and, in particular, the fact that several operators have an ability to enter that market jointly, but not alone.

89      Thus, in the present case, the Commission rightly assessed Matrix, together with Niche, as a potential competitor, by checking whether, through the Niche/Matrix agreement, these two companies were able to enter the market with the generic perindopril produced as a result of the implementation of their agreement.

90      It should be noted, in that respect, that, contrary to the applicants’ assertions, the joint perindopril project resulting from that agreement had not been abandoned at the date of conclusion of the agreements with Servier. The applicants merely allege that that project was abandoned, and submit that the negotiations between Servier and Niche which began in May 2004 were concealed from Matrix, that Niche breached a clause of the Niche/Matrix agreement, that correspondence from Niche after the conclusion of the agreements with Servier indicated that the project was ‘doomed’ and that Niche received legal advice that the project should be abandoned. In doing so, they in no way call into question the findings in the contested decision, based inter alia on the replies of Niche and Matrix to the Commission’s requests for information and on the various exchanges between Niche and Matrix concerning the implementation of their agreement (see also paragraphs 121 and 127 below), according to which Niche and Matrix had initially continued their joint project based on the Niche/Matrix agreement after the conclusion of the Servier agreements on 8 February 2005, before Matrix declared the suspension of the Niche/Matrix agreement with immediate effect on 22 June 2005, and neither party at any point considered it necessary to terminate that agreement (recitals 625 to 632 of the contested decision). The Commission therefore rightly took that agreement into account in its analysis of potential competition.

91      That conclusion is not called into question by the fact that Niche and Matrix are two autonomous companies (see paragraph 68 above). That autonomy does not change the fact that they concluded an agreement intended to allocate the tasks necessary in order to enter the market, and that agreement — as is apparent from the foregoing (see paragraph 88 above) — must be taken into account in assessing the ability of these companies to enter the market.

92      Nor is that conclusion called into question by the submission that Niche and Matrix each concluded an agreement with Servier and settled independently of one other (see paragraph 68 above). That allegation merely shows the autonomy of the two companies in question, which indeed allows each of them to conclude agreements with other companies independently of one another, but does not call into question the existence of the Niche/Matrix agreement that they concluded together and which they had not terminated at the time of, and because of, the conclusion of their agreements with Servier, which were both concluded on the same day (see paragraph 90 above).

93      The applicants’ argument that Servier would have settled with Niche independently of Matrix (see also paragraph 68 above) relates to Servier’s perception of Matrix as a potential competitor, namely that Servier did not regard Matrix as a potential competitor since it did not consider it necessary to conclude an agreement with Matrix to prevent it from entering the market. In the present case, it suffices to point out that Servier did conclude such an agreement with Matrix, which constitutes particularly strong evidence for the purpose of establishing the perception of potential competition by the incumbent operator (see paragraph 65 above), and, in this instance, Servier’s perception that Matrix was a potential competitor.

94      It should also be added that, contrary to the applicants’ assertions, the Commission cannot be criticised on the ground that it gave decisive weight to the Niche/Matrix agreement in its analysis of potential competition. As the Commission rightly submits, it did not consider in the contested decision that the conclusion of an agreement to develop a product to compete with that of the originator undertaking was sufficient to render the two parties to that agreement potential competitors of that company. The Commission examined in detail the features of that agreement and its implementation in order to conclude that Niche and Matrix were potential competitors. Moreover, although the Commission primarily assessed the perindopril project based on the Niche/Matrix agreement, it did so because it considered that that agreement allowed Niche and Matrix to enter the market and thus be classified as potential competitors of Servier. It cannot however be inferred from this that the Commission would not have further developed its analysis of the possibilities for Matrix to find another partner, if it had considered that Niche’s partnership with Matrix was not sufficient to classify the latter as a potential competitor (see also paragraph 88 above).

95      In view of all of the foregoing, it is necessary to reject the arguments criticising the joint assessment of Niche and Matrix as potential competitors and to determine whether, in the present case, the Commission was right to consider that Niche and Matrix could be classified as potential competitors of Servier on the basis of the Niche/Matrix agreement.

96      In that respect, it must be emphasised, as a preliminary point, that the applicants do not dispute that Matrix had started preparing perindopril API batches for a commercial launch, that Niche had taken steps in order to obtain marketing authorisations (see paragraph 78 above), that it had concluded 14 agreements with commercial partners wishing to sell generic perindopril in Europe (see paragraph 79 above), and that the market entry of Niche and of Matrix would have been economically viable (see paragraph 82 above).

97      Those elements, since they show steps to achieve the production and the imminent marketing of perindopril and the profitability prospects of that marketing, show that Niche and Matrix not only intended to take the risk of entering the European market, but also had the ability to enter it.

98      It must therefore be determined whether the applicants’ arguments concerning the barriers linked to Servier’s patents, and the technical, regulatory and financial difficulties faced by Niche and Matrix, are capable of calling into question their ability and their intention to enter the market, as inferred from the abovementioned elements, and thus their real concrete possibilities of competing with Servier (see, to that effect, judgment delivered today, *Servier and Others* v *Commission*, T‑691/14, paragraphs 386 and 441).

(i)    *The barriers linked to Servier’s patents*

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

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

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

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

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

103    Contrary to the applicants’ assertions, those findings of the Commission are not vitiated by any errors.

104    Although, as the applicants state, the exclusive right conferred by a patent normally has the effect of keeping competitors away, since public regulations require them to respect that exclusive right (judgment of 1 July 2010, *AstraZeneca* v *Commission*, T‑321/05, EU:T:2010:266, paragraph 362), that competition-excluding effect concerns the actual competitors selling infringing products. A patent confers on its holder the exclusive right to use an invention with a view to manufacturing industrial products and putting them into circulation for the first time, as well as the right to oppose infringements (judgments of 31 October 1974, *Centrafarm and de Peijper*, 15/74, EU:C:1974:114, paragraph 9; of 14 July 1981, *Merck*, 187/80, EU:C:1981:180, paragraph 9; and of 16 July 2015, *Huawei Technologies*, C‑170/13, EU:C:2015:477, paragraph 46), but does not, by itself, preclude operators from taking the necessary steps to be in a position to enter the relevant market following the expiry of the patent and, thus, exerting competitive pressure on the patent holder characteristic of the existence of potential competition before that expiry. Nor does it preclude operators from carrying out the actions necessary for the manufacture and marketing of a non-infringing product, as a result of which they may be regarded as actual competitors of the patent holder upon their market entry and, as the case may be, as potential competitors until that market entry (see, to that effect, judgment of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraph 164).

105    Furthermore, ruling on the appeal brought against the judgment of 1 July 2010, *AstraZeneca* v *Commission* (T‑321/05, EU:T:2010:266), the Court of Justice itself acknowledged, in its judgment of 6 December 2012, *AstraZeneca* v *Commission* (C‑457/10 P, EU:C:2012:770, paragraph 108), that potential competition could exist in a market even before the expiry of a patent. More specifically, the Court of Justice held, in that judgment, to which the Commission referred in recitals 1165 and 1169 of the contested decision, that supplementary protection certificates which are intended to extend the protection conferred by a patent lead to significant exclusionary effects after the expiry of the patents, but that they were ‘also liable to alter the structure of the market by adversely affecting potential competition even before that expiry’.

106    That is particularly the case in the pharmaceutical sector, in which, under the legislation governing the grant of the marketing authorisations required in order to market a medicinal product, the competent authorities may grant a marketing authorisation for a generic product even if the reference product is protected by a patent. It follows from Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended, that marketing authorisation applications for generic products may be dealt with in a shortened procedure based on the results of tests and trials submitted in the marketing authorisation application for the originator product and that the data relating to these results may be used and allow, consequently, the grant of a marketing authorisation before the expiry of the patent on the originator product (Article 10 of Directive 2001/83; see also recitals 74 and 75 of the contested decision). Thus, the legislation on the marketing of pharmaceutical products itself states that a generic company can enter the market with a lawfully granted marketing authorisation or, at the very least, begin the procedure for obtaining the marketing authorisation during the protection period of the originator undertaking’s patent.

107    Furthermore, the system of protection of patents is designed in such a way that, although patents are presumed to be valid from the date of their registration (judgment of 1 July 2010, *AstraZeneca* v *Commission*, T‑321/05, EU:T:2010:266, paragraph 362), that presumption of validity does not automatically imply that all products placed on the market are infringing (see, to that effect, judgment of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraphs 121 and 122). As the Commission rightly points out in the contested decision (recitals 1169 to 1171), there is no presumption of infringement, since infringement must be established by a court. As can be seen from the judgment of 25 February 1986, *Windsurfing International* v *Commission* (193/83, EU:C:1986:75, paragraph 52), if a private operator which holds a patent could substitute its own discretion for that of the competent authority as regards the existence of an infringement of its patent, it could use that discretion in order to extend the protection of its patent (see also recital 1171 and footnote 1642 of the contested decision).

108    Contrary to the applicants’ assertions, the Commission’s approach in that respect does not overturn the presumption of validity enjoyed by patents. The applicants rely on an erroneous reading of the contested decision, since the Commission indicated in that decision, in essence and correctly (see paragraphs 105 to 107 above), not that the patent was presumed invalid until the adoption of a court decision relating to its validity and to the existence of an infringement, but that, until the adoption of such a decision, the presumption of validity of the patent did not prevent an at risk market entry (see recitals 1171 and 1176 of the contested decision).

109    It should be noted that the same lack of a presumption of infringement applies in the event of a declaration of validity of the patent in question by a competent authority. Since a patent does not, as such, prevent the market entry of actual or potential competitors, the declaration of validity of that patent, if it is not accompanied by a declaration of infringement, does not preclude such competition.

110    It is therefore possible for an operator to take the risk of entering the market with a product, including by potentially infringing the patent in force, and that at risk entry or launch (see inter alia recitals 75 and 1176 of the contested decision) could be successful, if the patent holder decides not to bring an infringement action or, in the event that such an action is brought, if that infringement action is dismissed (see, to that effect, judgment of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraphs 128 and 165).

111    It may also be noted in that regard that, contrary to the applicants assertions, the Commission was entitled to take the view, in recitals 1132 and 1169 of the contested decision, that patent challenges and decisions in relation to these patents constituted an ‘expression of competition’ as regards patents. In view of the risk of infringement to which all generic companies are exposed and the fact that private operators are not competent to determine whether infringement has occurred (see paragraph 107 above), litigation is one of the means by which generic companies can reduce that risk and enter the market, either by obtaining a declaration of non-infringement or by having the potentially infringed patent declared invalid (see, to that effect, judgment of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraph 122). It also follows that, as long as the generic company has the possibility of bringing litigation to challenge the patents concerned and thus clear a path to the market, it may be considered that those patents do not constitute insurmountable barriers to access and, accordingly, do not prevent potential competition from taking place.

112    It follows from all the foregoing that the Commission did not err in finding that, in the present case, Servier’s patents were not insurmountable barriers to the market entry of the generic companies. At the time the agreements at issue were concluded, no final decision on the merits of an infringement action had found that the products of those companies, including those of Niche and Matrix, were infringing. The Commission correctly considered that Servier’s patents did not create a ‘blocking position’ within the meaning of the 2004 Guidelines on technology transfer agreements (see paragraph 99 above), even if those guidelines were applicable. Since only a decision finding an infringement of the intellectual property right concerned, that is to say an infringement of the patent at issue, could prevent an at risk market entry, the ‘court decisions’ mentioned in those guidelines (paragraph 32) as evidence of the existence of a blocking position refer to decisions finding an infringement of that patent, and no such decisions were adopted in the present case (judgment delivered today, *Servier and Others* v *Commission*, T‑691/14, paragraph 370).

113    Contrary to the applicants’ assertions, in the absence of any decisions finding an infringement and, a fortiori, of any final decisions in that respect and, thus, in the absence of any insurmountable barriers arising from those patents, the Commission rightly took account of the parties’ subjective perceptions of the patent litigation in order to determine whether the generic companies had real concrete possibilities of overcoming the patent-related barriers and entering the market (see, to that effect, judgment of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraph 141). The assessments of the parties themselves concerning the possibilities of those patents being declared invalid or being infringed are liable to shed light on those parties’ intentions as regards, amongst other things, litigation. In particular, when those assessments are made by generic companies, they may contribute to establishing their intention — taking into account their subjective perception of the patents concerned — of entering the market, but not their ability to enter as such, since establishing the infringement and invalidity of patents falls within the exclusive competence of the national courts and the EPO (see paragraph 107 above and paragraph 172 below). Since intention is regarded as a relevant criterion for determining whether there are real concrete possibilities of entering the market (see paragraph 46 above), it follows that the parties’ subjective assessments may validly be taken into account for the purpose of establishing those possibilities. It must nevertheless be pointed out that, inasmuch as the intention of entering a market, while relevant for the purposes of verifying whether a company may be classified as a potential competitor, is used only on a supplementary basis (see also paragraph 46 above), those assessments are also used only on a supplementary basis in determining whether that company constitutes a potential competitor. They must therefore be compared with elements on the basis of which the ability to enter the market can be assessed as well as, where appropriate, other elements also capable of showing a company’s intentions as regards market entry, in order to determine whether it may be concluded that there are real concrete possibilities of overcoming the patent-related barriers (judgment delivered today, *Servier and Others* v *Commission*, T‑691/14, paragraph 384).

114    Similarly, contrary to the applicants’ further arguments, the fact that the Commission mentioned alternative means of accessing the market, in particular launching at risk (see paragraph 101 above), does not disregard the rules applicable to the determination of potential competition. By referring to those alternatives in the part of the contested decision setting out the rules that it intended to apply in order to determine whether the generic companies in question were potential competitors, the Commission merely referred to possibilities of entering a market on which patents are in force. Subsequently, in its analysis of each of the agreements at issue, it examined whether those possibilities could be regarded as real and concrete and whether they corresponded to an economically viable strategy in view of the specific features of each of the generic companies in question. It did not, however, infer from the mere existence of those alternative possibilities that the generic companies, and in particular Niche and Matrix, had real concrete possibilities of entering the market on the basis of an economically viable strategy.

115    Furthermore, inasmuch as the applicants dispute the existence in the present case of real concrete possibilities for Niche and Matrix to overcome the patent-related barriers, it must be noted that they rely on a comment made by Niche concerning its intention not to enter the market. That comment, according to which the risk for Niche of being ordered to pay damages to Servier for infringement of its patents was too high for it to enter the market at risk, set out in Niche’s reply to the Statement of Objections, is not — in the absence inter alia of any challenges to the recitals of the contested decision describing the patent litigation brought by Niche against Servier concerning the perindopril developed in partnership with Matrix — sufficient to call into question the classification of Niche and Matrix as potential competitors. It should be added that the same would apply if it were necessary to take into account the documents from Niche or its advisers submitted by the applicants for the purpose of establishing Niche’s serious concerns about infringing Servier’s patents and thus the difficulties for Matrix of finding a partner willing to conclude a partnership in those circumstances. Like the abovementioned comment by Niche indicating an intention not to enter the market, those documents — if it were established that they could also be interpreted as establishing such an intention — would have to be compared with the litigation brought by Niche, which shows, at the very least, a materialised, and not merely theoretical, intention to overcome the patent-related barriers (see, to that effect, judgment delivered today, *Niche Generics* v *Commission*, T‑701/14, paragraph 139).

116    The applicants’ arguments in relation to the barriers linked to Servier’s patents cannot, therefore, call into question the real concrete possibilities for Niche and Matrix to compete with Servier.

(ii) *Technical difficulties*

117    It should be noted, at the outset, that since assessing the real concrete possibilities of manufacturing a product is not the same as assessing the real concrete possibilities of obtaining a marketing authorisation, but some manufacturing problems may have consequences as regards the grant of a marketing authorisation, the applicants’ arguments concerning the technical difficulties of Niche and Matrix will be considered before those relating to their difficulties in obtaining the requested marketing authorisations.

118    It should be noted that those technical difficulties are only briefly mentioned by the Commission in the part of the contested decision specifically devoted to the assessment of Niche and Matrix as potential competitors (recitals 1282 to 1298 and 1421 to 1434; see also paragraphs 77 to 83 above) and that the Commission does not discuss them in the part of the contested decision setting out the criteria for assessing potential competition (recitals 1156 to 1183). However, those difficulties are examined in detail in the part of the contested decision describing the agreements between Servier, on the one hand, and Niche and Matrix, on the other, and the circumstances in which they were concluded (recitals 463 to 479) and it is apparent that the Commission primarily relied on the efforts made to find solutions to the technical difficulties in question and the lack of evidence that those difficulties were insurmountable (recital 479; see also recitals 1296 and 1429).

119    The applicants do not dispute that Matrix and Niche worked to obtain a marketable product and mainly submit, in essence, that the technical barriers involved in manufacturing that product were insurmountable.

120    With regard to the barrier represented by the impurities detected, the applicants essentially conclude that it was insurmountable because of the cessation of production requested by Niche in January 2005.

121    However, it is clear from the email in question, dated 4 January 2005, sent by Niche to Unichem and Matrix, that Niche asked Matrix to continue its research in relation to the origin of the impurity, taking into account Unichem’s different analysis in that respect, and to stop its production, if possible, until a solution was found to the impurity problem, in the event that the rate of impurity in the material already produced was higher than 0.1% The cessation of production requested by Niche was therefore hypothetical, and an email sent by Niche to Matrix on 7 March 2005 indicated, moreover, that the manufacturing process was stopped only after the Agreement was concluded (recital 626 of the contested decision). In addition, and in any event, that cessation of production was temporary, since it was limited to the time required to resolve the technical difficulty in question, the resolution of which was, moreover, also the subject of an exchange between Matrix and Unichem beginning on 21 January 2005. Above all, even if that cessation of production had led to the ‘worst case scenario’ referred to by Niche, that is to say having to ‘start production afresh’ (recital 474 of the contested decision), it must be pointed out that the possibility of starting afresh demonstrates precisely that the impurity problem was not insurmountable.

122    As regards tablet hardness, the applicants refer to a report on tests carried out in March 2005 on the product of Niche and Matrix sent by Niche’s consultant to the latter on 7 April 2005, from which it appears that tablet hardness problems persisted at that date. However, that document — which was drawn up after the conclusion of the agreements between Servier, on the one hand, and Niche and Matrix, on the other, on 8 February 2005 and which relates to information which post-dates those agreements — reflects the implementation of the agreements and, in particular, of their provisions prohibiting the manufacture of a product infringing Servier’s patents. Accordingly, it cannot be determined from that document whether Niche and Matrix encountered insurmountable technical difficulties or whether they had limited their efforts to overcome those difficulties in view of those provisions (see, to that effect, judgment delivered today, *Servier and Others* v *Commission*, T‑691/14, paragraph 464).

123    It follows that the applicants have not established that the technical difficulties encountered by Niche and Matrix were insurmountable. While they also argue that these difficulties would, at the very least, have delayed the development process of the product of Niche and Matrix, it must be noted that, given the average time of two to three years required to develop a perindopril API technology for commercial use, found by the Commission in the contested decision on the basis of the facts of the case (footnote 1669) and not disputed by the applicants, and the fact that Niche and Matrix started their collaboration in March 2001, the date of the Niche/Matrix agreement, the efforts taken into account by the Commission, in 2004-2005, were the last efforts before the finalisation in the present case of the regulatory procedures, which are normally carried out in parallel with the last steps in product development. Thus, such efforts, made at an advanced stage of development of the generic product, are likely, if successful, to allow sufficiently fast market entry and may be regarded as exerting competitive pressure on the originator undertaking (judgment delivered today, *Servier and Others* v *Commission*, T‑691/14, paragraph 459). It follows that the delays suffered at that stage are not sufficient in themselves to preclude the classification of Niche and Matrix as potential competitors, since they do not call into question the competitive pressure resulting from the efforts made by those companies at an advanced stage of the development of their product (see also paragraph 59 above).

124    The applicants’ arguments relating to the technical difficulties encountered by Niche and Matrix cannot, therefore, call into question those companies’ real concrete possibilities of competing with Servier.

(iii) *Regulatory difficulties*

125    It should be noted, as a preliminary point, that the Commission did not deny, in the contested decision, that the regulatory barriers linked to the procedure for granting marketing authorisations could constitute insurmountable barriers to entry. It nevertheless considered that the absence of a marketing authorisation did not mean that the product could not reach the market, as long as the generic company continued its efforts to obtain regulatory approval and these attempts did not face objectively insurmountable problems at the time of the settlement (recitals 1180 and 1181). The Commission found, more specifically as regards Niche and Matrix, that steps had been taken to obtain marketing authorisations, which were expected to be obtained in 2005 and one of which had actually been obtained in the Netherlands by a customer of Niche in May 2005 (recital 1422 of the contested decision; see also paragraph 78 above).

126    It must be held that the arguments put forward by the applicants do not establish that Niche and Matrix faced objectively insurmountable problems in the marketing authorisation procedure.

127    First, the applicants rely on a letter from the United Kingdom regulatory authority dated 19 April 2005, to which they considered they were unable to respond. Apart from the fact that the applicants mention only one request of that nature whereas Niche and its partners had initiated marketing authorisation procedures in several European countries (the Czech Republic, Denmark, France, Hungary, the Netherlands, Portugal, Slovenia, Sweden, the United Kingdom) (see recital 454 of the contested decision), it should be noted that, as the Commission submits, it is apparent from a letter of 13 May 2005 from Niche to Matrix that Niche was confident that it could respond to most of the requests and that it would leave it to Matrix to answer two of them. It follows that Niche maintained its efforts to obtain the marketing authorisation concerned and that it cannot be inferred from the request of the United Kingdom regulatory authority that Niche’s attempts to obtain a marketing authorisation in that country faced objectively insurmountable problems.

128    Secondly, the applicants rely on the problem of the impurities detected in the product of Niche and Matrix. The Court has concluded that that problem was not insurmountable and, accordingly, that it did not prevent the development of a product which could be placed on the market (see paragraph 123 above). It can therefore be concluded that, even if the studies and other additional actions which that technical difficulty allegedly made necessary in order to obtain the marketing authorisation would have delayed the grant of that marketing authorisation, they would not have made the grant of that authorisation impossible.

129    With regard to these delays, it should be emphasised that, since competitive pressure is likely to be exerted from the submission of the application for a marketing authorisation and for as long as efforts are made to obtain the marketing authorisation without encountering objectively insurmountable problems, the delays suffered in the marketing authorisation procedures do not suffice, by themselves, to preclude the classification of the marketing authorisation applicants concerned as potential competitors. In addition, since the marketing authorisation procedure generally precedes market entry and since the grant of a marketing authorisation allows, in principle, immediate market entry and thus effective competition, to require that the marketing authorisation be obtained particularly quickly or without any delays would amount to denying the difference between actual competition and potential competition (see judgment delivered today, *Servier and Others* v *Commission*, T‑691/14, paragraph 478 and the case-law cited).

130    The applicants’ arguments relating to the regulatory obstacles faced by Niche and Matrix cannot therefore call into question their real concrete possibilities of competing with Servier, even if, as the applicants maintain, the Commission should not have taken into account the marketing authorisation obtained by a customer of Niche in May 2005 in order to infer such possibilities from it.

(iv) *Financial difficulties*

131    It should be noted that, by arguing that Niche had serious financial difficulties and that it did not have the necessary funds to pursue the patent litigation, the applicants seek to call into question Niche’s financial capacity to enter the market at risk.

132    However, the applicants rely, in that respect, on a statement to that effect by Niche in its response to the Statement of Objections and on the letter from Niche’s lawyer dated 5 February 2005, that is to say three days before the conclusion of the Agreement, according to which any order for damages relating to the 947 patent would exceed Niche’s financial capacity. They do not, by contrast, provide any estimate, even approximate, of the damages invoked or of Niche’s financial situation and they fail to mention either the payments and loans made by Unichem and Niche’s management to cover the litigation expenses or the envisaged sharing of those litigation expenses. It cannot, therefore, be considered that the applicants have established that Niche was, in view of its finances, unable to enter the market with Matrix.

133    It follows from all the foregoing that the applicants’ arguments concerning the barriers linked to Servier’s patents and to the technical, regulatory and financial difficulties of Niche and Matrix do not call into question their ability and their intention to enter the market, as established by the Commission in the contested decision (see paragraph 97 above). The Commission was therefore right to consider that, on the basis of the Niche/Matrix agreement, as implemented, Niche and Matrix could be classified as potential competitors of Servier.

134    It also follows that the Commission was not required, in order to determine whether Matrix could be classified as a potential competitor, to examine whether it had real concrete possibilities of finding other partners, with the result that the applicants’ arguments criticising that analysis (see paragraphs 69 and 70 above) must be rejected as ineffective.

135    Consequently, the plea alleging errors of law and of assessment in the analysis of Matrix as a potential competitor must be rejected.

2.      **The plea alleging errors of law and of assessment in the classification of the Agreement as a restriction by object**

(a)    **The misinterpretation and misapplication of the concept of ‘restriction by object’**

(1)    *Arguments of the parties*

136    The applicants submit, in the first place, that the Commission sought to broaden the concept of ‘restriction by object’ by concluding that the Agreement was restrictive of competition by object on the basis of a mere possibility of harm to competition. However, the concept of ‘restriction by object’ should be interpreted restrictively and concern only collusions which, by their very nature, are harmful to the proper functioning of normal competition, because they necessarily lead to a restriction of competition, based on experience. The applicants reject any analogy in that regard between the Agreement and the agreement at issue in the judgment of 20 November 2008, *Beef Industry Development Society and Barry Brothers* (C‑209/07, EU:C:2008:643).

137    The applicants submit, in the second place, that, rather than the ‘value transfer’ criterion, the Commission should have applied the criterion of the ‘scope of the patent’ to assess whether the patent agreements implemented are restrictive by object, since that criterion ensures a ‘proper balance’ between competition law and the protection of patent rights and respects the presumption of validity of patents.

138    The applicants submit, on the basis of that criterion, that the Commission incorrectly assessed the non-marketing and non-challenge clauses in the Agreement, since the obligations imposed on Matrix by those clauses fell within the scope of the patents at issue and, in particular, did not prevent Matrix from marketing non-infringing perindopril. They also dispute the Commission’s interpretation of Clauses 1, 4 and 7 of the Agreement, from which it is clear, contrary to the Commission’s considerations, that the non-marketing obligation concerns Servier’s process patents (the 339, 340 and 341 patents) and not the 947 patent.

139    The Commission contends that, in order to reach the conclusion that Article 101 TFEU had been infringed, it applied the test of the restriction of competition by object, as defined by the case-law, by examining whether there was any indication that the agreements at issue would cause a sufficient degree of harm to competition, by taking account, in respect of each agreement, of the content of its terms, the objectives it sought to attain, the economic and legal context of which it formed a part and the intentions of the parties. It notes the three criteria used in the present case to reach the conclusion that the Agreement restricts competition by object, namely the potential competition between the originator company and the generic company, the commitment of the generic company to limit its efforts to enter the market and the existence of a value transfer from the originator company representing a significant inducement to reduce the incentives of the generic company to pursue such efforts. It states that the consideration, as part of the first criterion, of whether there is potential competition, and therefore whether there is the real concrete possibility of market entry, does not imply that a mere possibility of restricting competition constitutes a restriction by object. The Commission considers, lastly, that the arguments put forward by the applicants to distinguish the present case from the case which gave rise to the judgment of 20 November 2008, *Beef Industry Development Society and Barry Brothers* (C‑209/07, EU:C:2008:643) are unconvincing.

140    With regard to the complaint concerning the criterion of the scope of the patent, the Commission considers that that complaint must be rejected as ineffective, since the Agreement goes well beyond the scope of Servier’s process patents. It refers, moreover, to the contested decision, according to which, even in the case of restrictions falling within the scope of the patent, that is to say restrictions which, in theory, could have been obtained by applying Servier’s process patents, such restrictions will be anticompetitive where, in practice, they are obtained not through the parties’ assessment of the strength of the patent, but as a result of a value transfer from the originator undertaking substantially reducing the incentives of the generic company to pursue its efforts independently to enter one or more EU markets with a generic product.

141    Furthermore, the Commission considers that the non-marketing clause prohibited Matrix from entering the market with any perindopril using a process that infringed the process patents and that the claim that the 947 patent was not included in that clause is irrelevant, since any infringement of that patent could result in proceedings being brought by Servier. It adds that the applicants completely disregard the non-challenge clause.

(2)    *Findings of the Court*

(i)    *Errors of law*

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

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

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

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

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

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

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

149    The Commission then applied the three criteria referred to in paragraph 148 above to each of the patent dispute settlement agreements at issue and concluded, in respect of each of those agreements, that those three criteria were met and that, consequently, those agreements should be classified, inter alia, as restrictions of competition by object.

–       *Restrictions of competition by object*

150    Article 101(1) TFEU provides that all agreements between undertakings, decisions by associations of undertakings and concerted practices which have ‘as their object or effect’ the prevention, restriction or distortion of competition within the internal market are to be prohibited as incompatible with the internal market. According to settled case-law since the judgment of 30 June 1966, *LTM* (56/65, EU:C:1966:38, p. 249), the alternative nature of those requirements, indicated by the use of the conjunction ‘or’, leads to the need to consider, in the first place, the precise purpose of the agreement, in the economic context in which it is to be applied. Where, however, an analysis of the terms of the agreement 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).

151    The concept of restriction of competition by object can therefore 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).

152    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.

153    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).

154    It must be held that, contrary to the applicants’ assertions, the Commission, in the contested decision, correctly applied the concept of restriction of competition by object and the criteria for assessing that concept, as explained in paragraphs 151 to 153 above. Indeed, the Commission stated, in recitals 1110 and 1113 of the contested decision, that restrictions by object are ‘those which, “by their very nature”, can be regarded as being injurious to the proper functioning of normal competition’, that ‘[i]n 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, ‘[w]hen 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).

155    In particular, it cannot be maintained that the Commission erred in law by considering that a mere possibility that the Agreement would harm competition was sufficient in order to classify it as a restriction of competition by object (see paragraph 136 above). It is true that, in recital 1111 of the contested decision, the Commission stated, citing the case-law of the Court of Justice (judgments of 4 June 2009, *T-Mobile Netherlands and Others*, C‑8/08, EU:C:2009:343, paragraph 31, and of 14 March 2013, *Allianz Hungária Biztosító and Others*, C‑32/11, EU:C:2013:160, paragraphs 35 to 38), that, ‘[i]n order for an agreement to be regarded as having an anticompetitive object, it is sufficient that it has the potential to have a negative impact on competition’ and that ‘[i]n other words, the agreement must simply be capable in an individual case, having regard to the specific legal and economic context, of resulting in the prevention, restriction or distortion of competition within the internal market’.

156    However, it is necessary, first of all, to bear in mind that the Commission correctly set out the case-law on the definition and assessment of restrictions of competition by object in the contested decision, in particular in recitals 1109 and 1110, 1112 to 1117 and 1211 (see paragraph 154 above), and to note that it applied that case-law in the analysis of the Agreement (see, inter alia, recitals 1475 to 1481 of the contested decision).

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

158    In addition, as regards the applicants’ argument that the concept of infringement by object should be interpreted restrictively, contrary to the approach taken by the Commission in the contested decision (see paragraph 136 above), it must be noted that, in the judgment of 11 September 2014, *CB* v *Commission* (C‑67/13 P, EU:C:2014:2204, paragraph 58), the Court of Justice stated that the concept of restriction of competition by object could be applied only to certain types of coordination between undertakings which reveal a sufficient degree of harm to competition that it may be found that there is no need to examine their effects and not to agreements which are in no way established to be, by their very nature, harmful to the proper functioning of normal competition. It therefore held that the General Court had erred in law in finding that the concept of restriction of competition by object must not be interpreted restrictively. The Court of Justice did not, however, call into question the case-law according to which the types of agreement referred to in Article 101(1)(a) to (e) TFEU do not constitute an exhaustive list of prohibited collusion (judgment of 20 November 2008, *Beef Industry Development Society and Barry Brothers*, C‑209/07, EU:C:2008:643, paragraph 23; see also, to that effect, judgment of 11 September 2014, *CB* v *Commission*, C‑67/13 P, EU:C:2014:2204, paragraph 58), which is clear from the use of the term ‘in particular’ in Article 101(1) TFEU (Opinion of Advocate General Trstenjak in *Beef Industry Development Society and Barry Brothers*, C‑209/07, EU:C:2008:467, point 46).

159    It must next be pointed out that, in the present case, the Commission took an approach consistent with the judgment of 11 September 2014, *CB* v *Commission* (C‑67/13 P, EU:C:2014:2204), in assessing the agreements at issue in the light of the criteria set out in paragraphs 151 to 153 above (see paragraph 156 above), criteria which are in themselves restrictive, since they require the identification of a sufficient degree of harm. Contrary to the applicants’ assertions, the Commission’s analysis did not, a priori, have to apply a more restrictive approach than that entailed by the criteria for assessing the concept of restriction of competition by object, but it required the identification of a restriction of competition revealing a sufficient degree of harm or, failing that, an analysis of the actual anticompetitive effects of the agreements at issue.

160    Likewise, contrary to the applicants’ submissions (see paragraph 136 above), 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).

161    Nor does the case-law require that an agreement be considered to be prima facie or undoubtedly sufficiently harmful to competition, without a concrete and individual examination of its content, its purpose and its legal and economic context being carried out by the Commission or the Courts of the European Union, in order to be regarded as a restriction of competition by object within the meaning of Article 101(1) TFEU (see, to that effect, judgments of 14 March 2013, *Allianz Hungária Biztosító and Others*, C‑32/11, EU:C:2013:160, paragraph 51, and of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraph 775).

162    Having set out the conditions for applying the concept of restriction of competition by object and having examined the applicants’ complaints criticising the interpretation of that concept, it must be noted that, in the present case, the Agreement was intended, according to the applicants, to settle disputes between the contracting parties and was concluded in the specific context of patent law, since the disputes in question concerned Servier’s patents. Since determining whether there is a restriction by object entails an examination of the content of the terms of the agreement in question, its objectives, and its economic and legal context (see paragraph 152 above), it is necessary in the present case to analyse the clauses prohibiting patent challenges and the clauses prohibiting the marketing of products which infringe those patents, contained in settlement agreements in general and in the Agreement in particular, in the light of their objective of settling patent disputes and their specific context, namely that of patents, in order to verify whether the Commission, correctly and in accordance with legally appropriate criteria, classified the Agreement as restrictive of competition by object.

–       *Intellectual property rights and, in particular, patents*

163    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).

164    The exercise of the rights arising under a patent granted in accordance with the legislation of a Member State does not, of itself, constitute an infringement of the rules on competition laid down by the Treaty (judgment of 29 February 1968, *Parke, Davis and Co.*, 24/67, EU:C:1968:11, p. 71). Intellectual property rules are even essential in order to maintain competition undistorted on the internal market (judgment of 16 April 2013, *Spain and Italy* v *Council*, C‑274/11 and C‑295/11, EU:C:2013:240, paragraph 22). First, by rewarding the creative effort of the inventor, patent law contributes to promoting an environment conducive to innovation and investment and, secondly, it is intended to make public the modes of operation of inventions and thus allow further breakthroughs to emerge. Paragraph 7 of the 2004 Guidelines on technology transfer agreements, the provisions of which were included in their entirety in point 7 of the Guidelines of 28 March 2014 on the application of Article 101 of the Treaty on the Functioning of the European Union to technology transfer agreements (OJ 2014 C 89, p. 3; ‘the 2014 Guidelines on technology transfer agreements’), thus acknowledges that:

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

165    According to settled case-law, the right to property, which includes intellectual property rights, constitutes a general principle of EU law (see 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).

166    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).

167    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).

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

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

170    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).

171    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).

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

173    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).

174    Lastly, it must be noted that intellectual property rights are protected by the Charter of Fundamental Rights. Under Article 17(1) of the Charter of Fundamental Rights, to which the Treaty of Lisbon has conferred the same legal value as the Treaties (Article 6(1) TEU), ‘[e]veryone has the right to own, use, dispose of and bequeath his or her lawfully acquired possessions’, ‘[n]o 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 ‘[t]he 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 ‘[i]ntellectual 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 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).

–       *Patent dispute settlement agreements*

175    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 — like Matrix in the present case (see paragraph 17 above) — 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.

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

177    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 Articles 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 ‘[t]he 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 ‘[s]ettlements can also save courts and/or competent administrative bodies effort in deciding on the matter and can therefore give rise to welfare enhancing benefits’.

178    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).

179    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 also 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, and as the applicants essentially argue, 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.

180    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 those patents.

181    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.

–       *The reconciliation of patent settlement agreements and competition law*

182    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, *BAT Cigaretten-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).

183    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).

184    It is therefore necessary to identify the relevant factors which justify a conclusion that a non-challenge clause in respect of a patent and, more broadly, a patent settlement agreement restricts competition by object, bearing in mind that determining whether there is a restriction by object entails an examination of the content of the terms of the agreement in question, its objectives, and its economic and legal context (see paragraph 162 above).

185    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.

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

187    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).

188    First, as the applicants submit, 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, as the applicants submit, the Commission stated, in paragraph 209 of the 2004 Guidelines on technology transfer agreements, that ‘[i]t 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.

189    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 163 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 186 above).

190    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).

191    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 186 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).

192    The presence of non-marketing and non-challenge clauses whose scope is limited to that of the patent in question is, however, problematic when it is apparent that the generic company’s agreement to those clauses is not based on its recognition of the validity of the patent. As the Commission rightly points out, ‘even if the limitations in the agreement on the generic undertaking’s commercial autonomy do not go beyond the material scope of the patent, they constitute a breach of Article 101 [TFEU] when those limitations cannot be justified and do not result from the parties’ assessment of the merits of the exclusive right itself’ (recital 1137 of the contested decision).

193    In that respect, it should be noted that the existence of a ‘reverse payment’, that is to say a payment from the originator undertaking to the generic undertaking, is doubly suspect in the context of a settlement agreement. In the first place, it must be borne in mind that a patent is intended to reward the creative effort of the inventor by allowing him to make a fair profit from his investment (see paragraph 163 above) and that a valid patent must, in principle, allow a transfer of value to its holder, and not vice versa. In the second place, the existence of a reverse payment gives rises to doubts as to whether the settlement is actually based on the recognition, by the parties to the agreement, of the validity of the patent in question.

194    However, the mere presence of a reverse payment does not mean that there is a restriction by object. It is possible that some reverse payments, where they are inherent in the settlement of the dispute in question, may be justified (see paragraphs 213 to 216 below). However, where an unjustified reverse payment occurs in the conclusion of the settlement, the generic company must then be regarded as having been induced 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.

195    It must be pointed out that, although neither the Commission nor the Courts of the European Union are competent to rule on the validity of the patent (see paragraphs 172 and 173 above), it is nevertheless the case that those institutions may, in the context of their respective powers and without ruling on the intrinsic validity of the patent, find that it has been used abnormally, in a manner which has no relation to its specific subject matter (see, to that effect, judgments of 29 February 1968, *Parke, Davis and Co.*, 24/67, EU:C:1968:11, pp. 71 and 72, and of 31 October 1974, *Centrafarm and de Peijper*, 15/74, EU:C:1974:114, paragraphs 7 and 8; see also, by analogy, judgments of 6 April 1995, *RTE and ITP* v *Commission*, C‑241/91 P and C‑242/91 P, EU:C:1995:98, paragraph 50, and of 4 October 2011, *Football Association Premier League and Others*, C‑403/08 and C‑429/08, EU:C:2011:631, paragraphs 104 to 106).

196    Inducing a competitor to accept non-marketing and non-challenge clauses, in the sense described in paragraph 194 above, or its corollary, accepting such clauses because of an inducement, constitutes an abnormal use of the patent.

197    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).

198    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.

199    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 186 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.

200    Where they involve an inducement, the agreements in question must therefore be regarded as market exclusion agreements, in which the ‘stayers’ are to compensate the ‘goers’. Such agreements actually constitute a buying-off of competition and must therefore be classified as restrictions of competition by object, as follows from the judgment of 20 November 2008, *Beef Industry Development Society and Barry Brothers* (C‑209/07, EU:C:2008:643, paragraphs 8 and 31 to 34), and the Opinion of Advocate General Trstenjak in *Beef Industry Development Society and Barry Brothers* (C‑209/07, EU:C:2008:467, point 75), referred to inter alia in recitals 1139 and 1140 of the contested decision. Contrary to the applicants’ assertions (see paragraph 136 above), the Commission rightly classified such agreements as market exclusion agreements, like the agreements examined in the judgment of 20 November 2008, *Beef Industry Development Society and Barry Brothers* (C‑209/07, EU:C:2008:643). The finding of an inducement in those agreements implies that the market exclusion of generic companies which they entail results, not from the effects of the patents at issue and the legitimate objective of settling the disputes in relation to those patents, but rather from a payment or another commercial benefit, representing the consideration for that exclusion (see paragraph 199 above), like the financial consideration paid to the undertakings which agreed to leave the Irish beef market at issue in the case that gave rise to that judgment.

201    Moreover, the exclusion of competitors from the market constitutes an extreme form of market sharing and of limitation of production (judgment of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraph 435), which, in a context such as that of the agreements in question, reveals a degree of harm which is all the greater since the companies excluded are generic companies, the market entry of which is, as a rule, favourable to competition and which also contributes to the public interest in lowering the cost of healthcare. Furthermore, that market exclusion is augmented, in such agreements, by the fact that it is not possible for the generic undertaking to challenge the patent at issue.

202    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.

203    Thus, where a patent settlement agreement contains non-marketing and non-challenge clauses whose inherently restrictive nature (see paragraph 186 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 the time it was adopted.

204    Compliance with the scope of the patent at issue is therefore not sufficient to rule out the classification of the patent settlement agreements as a restriction by object. It therefore cannot — as the Commission rightly considered in recitals 1193 to 1201 of the contested decision and contrary to the applicants’ submissions (see paragraph 137 above) — be regarded by itself as a relevant criterion for assessing whether those agreements are restrictive by object. Such compliance with the scope of the patent at issue does not rule out the possibility that the market exclusion entailed by the patent settlement agreements is the result of an inducement to that effect, which constitutes abnormal use of the patent (see paragraph 196 above) and cannot be protected by virtue of respect for intellectual property rights and the presumption of validity attached to such rights (see, to that effect, judgment of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraph 495). It should be added that, contrary to the applicants’ further submission, the scope of the patent criterion was not implicitly adopted in the judgment of 25 February 1986, *Windsurfing International* v *Commission* (193/83, EU:C:1986:75). It is true that the Court of Justice, in finding that the first contested clause in that case was restrictive of competition, ruled out the invocation of the protection afforded by a patent which did not cover the product in question (paragraphs 51 to 53 of that judgment), but it also stated (paragraph 46 of that judgment) that, even on the assumption that the German patent in question covered the complete sailboard, and therefore included the board, which would have meant that the clause in question fell within the scope of the patent, that did not mean that that clause was compatible with Article 101 TFEU (see, to that effect, judgment of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraph 488).

205    It follows from the foregoing that the Commission rightly examined, in the contested decision, whether the agreements at issue 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.

206    By using that inducement criterion, the Commission precisely, and contrary to the applicants’ submissions (see paragraph 136 above), relied not on a mere possibility of harm to competition which depended on the outcome of litigation in relation to the patents at issue (see also paragraphs 155 to 157 above), but rather on a criterion — namely whether there was an inducement to accept non-marketing and non-challenge clauses — which supported the conclusion that the Agreement revealed a sufficient degree of harm to the proper functioning of normal competition.

207    Moreover, recital 1144 of the contested decision does not support the applicants’ argument. By stating in that recital, as highlighted by the applicants, that the mere removal of a possibility of entering the market constituted a restriction by object, the Commission precisely treated the Agreement as an agreement to exclude a potential competitor from the market, which is regarded as a restriction by object in the case-law (see, to that effect, judgment of 20 November 2008, *Beef Industry Development Society and Barry Brothers*, C‑209/07, EU:C:2008:643, paragraphs 9, 32 to 34 and 38; see, also, paragraph 200 above).

208    In addition, contrary to the applicants’ submissions, the Commission did not attach decisive weight to the ‘value transfer’ criterion (see paragraph 137 above). First, it must be noted, in so far as the applicants refer to the ‘value transfer’ criterion, that it is apparent from paragraphs 197 and 205 above that the Commission did not take the view that any benefit or value transfer was indicative of an object restrictive of competition, but rather that only agreements involving an inducement in the form of a benefit or value transfer — that is to say those in which the restrictive clauses can be explained by that inducement and not by the effects of the patents and the settlement of patent disputes — were sufficiently harmful to be classified as restrictions of competition by object (see also paragraphs 199 and 200 above). Secondly, it should be noted that the Commission did not merely examine whether there was such an inducement for the generic companies, but also, and rightly, whether there was a corresponding limitation of those companies’ efforts to compete with the originator company (see, inter alia, recital 1154 of the contested decision), two conditions which, if met, justify a finding of a restriction of competition by object (see paragraph 202 above).

209    It follows from all the foregoing that the Commission did not vitiate the contested decision by errors of law in 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.

(ii) *Errors of assessment*

210    The Commission also did not make an error of assessment in finding that the Agreement constituted a restriction of competition by object.

211    The Commission validly found that the Agreement contained an inducement for the applicants to accept the non-marketing and non-challenge clauses set out in the Agreement.

212    It should be noted, in that regard, that the applicants do not call into question the existence of non-marketing and non-challenge clauses in the Agreement. Nor have they submitted any evidence capable of calling into question the stipulation in Clause 9 of the Agreement of an inducive value transfer.

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

214    If the reverse payment provided for in a settlement agreement containing clauses restrictive of competition is aimed at compensating costs borne by the generic company that are inherent in that settlement, that payment cannot in principle be regarded as an inducement. Because they are inherent in the settlement agreement, there is an implication that those costs are, as such, based on the recognition of the validity of the disputed patents which that settlement is intended to affirm by bringing to an end the challenges to that validity and the potential infringement of those patents. It therefore cannot be considered that such a reverse payment creates doubts as to whether that settlement is based on the parties’ recognition of the validity of the patent in question (see paragraphs 193 and 194 above). Nevertheless, a finding of an inducement and of a restriction of competition by object is not ruled out in such a case. It means however that the Commission must prove that the amounts corresponding to those costs inherent in the settlement, even if they are established and precisely quantified by the parties to that settlement, are excessive (see, to that effect, recitals 1338, 1465, 1600 and 1973 of the contested decision). Such a disproportion would demonstrate that the costs concerned are not inherently linked with the settlement and, accordingly, it could not be inferred from the reimbursement of those costs that the settlement agreement is based on the recognition of the validity of the patents at issue.

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

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

217    In the present case, as the Commission correctly observed in recitals 1452 and 1453 of the contested decision, the existence of such an inducement is clear from the actual wording of the Agreement, which states in Clause 9 that, ‘[i]n consideration for the undertakings set out [in the Agreement], and the substantial costs and potential liabilities that may be incurred by Matrix as a consequence of ceasing its programme to develop and manufacture Perindopril made using the Process [at issue], Servier shall pay Matrix ... the sum of [GBP] 11 800 000.00’. The undertakings given are the non-marketing and non-challenge clauses, payment for which is thus expressly provided for in Clause 9. Moreover, as the Commission rightly submits in its written pleadings, the applicants have not offered any explanation for this value transfer other than that which is apparent from the terms of the Agreement.

218    Furthermore, it is irrelevant in this case that Clause 9 of the Agreement stipulates that the payment of the sum of GBP 11.8 million is consideration not only for the non-marketing and non-challenge clauses, but also — in some undefined proportion — consideration for other expenses, since that other compensation does not call into question the finding that the restrictive clauses at issue were purchased by Servier and, thus, the existence of an inducement for the applicants to accept those clauses.

219    Even on the assumption that those other expenses — or at least some of them —, described in the Agreement as the ‘substantial costs and potential liabilities that may be incurred by Matrix as a consequence of ceasing its programme to develop and manufacture Perindopril made using the Process [at issue]’, could be considered to be inherent in the settlement of the dispute such as to exclude their inducive effect, the Commission found (recitals 1462 to 1464 of the contested decision), and the applicants have not disputed, that Matrix had merely indicated the nature of the expenses covered and that it had neither established nor, a fortiori, quantified the ‘costs’ and ‘liabilities’ in question. It must be borne in mind that it is for the parties to the settlement to provide the Commission with evidence establishing that the costs allegedly inherent in the settlement are genuine, and to quantify those costs precisely (see paragraph 214 and 215 above).

220    It follows that the Commission validly found that the Agreement contained an inducement for Matrix to accept the non-marketing and non-challenge clauses set out in that agreement.

221    It also follows that, in view of the foregoing (see, in particular, paragraphs 194 to 200 above), the Commission rightly inferred from that finding that the Agreement restricted competition by object.

222    It is therefore irrelevant whether, as the applicants allege, the non-marketing and non-challenge clauses did not exceed the scope of the patents at issue. It must be borne in mind that the existence of an inducement for the generic company to accept non-marketing and non-challenge clauses justifies a finding of a restriction of competition by object, even if the settlement agreement includes clauses whose scope does not go beyond that of the patent at issue (see paragraphs 203 and 204 above). Without it being necessary to rule on whether the clauses of the Agreement fell within the scope of the patents at issue, the applicants’ arguments intended to establish that the obligations imposed by the non-marketing and non-challenge clauses did not exceed the scope of those patents (see paragraph 138 above) must, therefore, be rejected as ineffective.

223    It follows from all the foregoing that the first part of the present plea must be rejected.

(b)    **Incorrect assessment of the situation that would have existed had the Agreement not been concluded**

(1)    *Arguments of the parties*

224    The applicants, first, criticise the Commission for having considered that, in the absence of an agreement, Matrix would have continued or brought proceedings against Servier or negotiated a settlement providing for an early market entry. They state that, in the contested decision, the Commission ignored the fact that Matrix was not a party to the dispute between Servier and Niche and wrongly considered that Servier was likely to bring an action for infringement against Matrix, a mere API manufacturer, and that Matrix, which did not have the necessary resources for litigation, was likely to bring an action against Servier. Moreover, Matrix had no involvement in the negotiations regarding the Agreement and Servier was not willing to grant any early entry to the market, particularly since Matrix, a mere API manufacturer, did not have the capacity to enter the end-product market. The applicants submit, in the reply, that the consideration of the position in which Matrix would have found itself in the absence of an agreement and the options available to it does not amount to an analysis of the effects of the Agreement, but is part of the assessment of the context of the Agreement, which was disregarded by the Commission, the latter wrongly giving decisive weight to the inducive ‘value transfer’.

225    Secondly, the applicants argue that the obligations imposed by the Agreement did not prevent Matrix from doing anything it would have done without the Agreement, and they thus conclude that those obligations did not constitute serious restrictions of competition. Thus, the Agreement prevented it from manufacturing an API which infringed the process patents and Matrix never had any intention of manufacturing such an API. Moreover, the Agreement prevented it from bringing certain proceedings against Servier and there is no evidence that Matrix was able to bring such proceedings, or had even contemplated doing so. The applicants add that the Agreement did not have any competitively significant impact on account of Niche’s decision to abandon Matrix, which was therefore deprived of access to the market, irrespective of the Agreement.

226    The Commission contends that, for agreements such as that in the present case, which restrict competition without there being any need to take account of their effects, there is also no need to establish a counterfactual scenario, which was considered in the contested decision only as part of the analysis of the effects of the Agreement. In the rejoinder, it emphasises the importance, for the purposes of establishing a restriction of competition by object, of the criterion of the ‘value transfer’, for which the applicants have not provided any explanation other than that which follows from the terms of the Agreement.

227    The Commission then states, first, with regard to the counterfactual hypothesis concerning the proceedings between Matrix and Servier, that the applicants contradict themselves in arguing that Servier would never have sued Matrix, whereas they had previously asserted that Matrix would never have been able to enter the market without being sued by Servier. With regard to the counterfactual hypothesis concerning the conclusion of a settlement agreement providing for an early entry to the market, the Commission refers to its response to the arguments regarding potential competition and to the evidence and findings in the contested decision which the applicants have not disputed and which demonstrate that the significant amount of the value transfer induced Matrix to conclude the Agreement.

228    The Commission considers, secondly, that the applicants do not fully describe the obligations imposed by the Agreement. It adds that Servier would not have paid GBP 11.8 million to Matrix if Matrix would not have subsequently acted differently without the Agreement. Finally, in the Commission’s view, the Agreement removed all motivation and ability for Matrix to compete, given the obligation imposed on it to terminate the Niche/Matrix agreement.

(2)    *Findings of the Court*

229    It should be noted that the arguments put forward by the applicants in support of the second limb of the plea are all intended, in essence, to challenge the classification of Matrix as a potential competitor. By those arguments, the applicants dispute Matrix’s ability and intention to enter the market, and, in particular, its ability and its intention to bring proceedings against Servier’s patents and to manufacture an end product.

230    Since all of those arguments have been rejected in the context of the examination of the first plea (see paragraph 135 above), it follows that this part of the second plea must also be rejected. It should be added that the same would apply if, as the Commission submits (see paragraph 226 above and recital 1492 of the contested decision, to which the applicants also refer), the arguments in question were intended to call into question the counterfactual scenario established by the Commission in its analysis of the Agreement as restrictive of competition by effect, since it has been held that the Commission rightly classified the Agreement as a restriction of competition by object (see paragraphs 238 to 240 below).

231    The second plea must therefore be rejected in its entirety.

3.      **The plea alleging errors of law and of assessment in classifying the Agreement as a restriction by effect**

(a)    **Arguments of the parties**

(1)    *The absence of counterfactual analysis*

232    The applicants accuse the Commission of having erred in law by reusing its analysis of the Agreement as a restriction of competition by object for the purposes of analysing its restrictive effects. Thus, according to the applicants, by failing to analyse the difficulties encountered by Niche and Matrix, including, in particular, the fact that Matrix was not a generic company, the Commission did not establish the state of competition that would have existed without the Agreement and, accordingly, the anticompetitive effects of the Agreement.

233    The Commission states, on the contrary, that it carried out a counterfactual analysis in the contested decision, including an analysis of the competitive behaviour that Matrix would have been likely to adopt without the Agreement.

(2)    *The incorrect consideration of Servier’s dominant position*

234    The applicants submit that the Commission incorrectly relied on Servier’s dominant position to demonstrate that the Agreement had the effect of restricting competition, whereas that dominant position alone gave rise to the anticompetitive effects on the market.

235    The Commission contends that, in the contested decision, it took account of the content of the Agreement and the actual conditions in which it produced its effects, namely the economic and legal context, the nature of the product concerned, the real operating conditions and the structure of the market concerned, in order to assess whether the Agreement had had anticompetitive effects. It states that, in connection with that assessment, Servier’s market power was of utmost importance, since it increased the possibility of negative effects on competition within the market at issue.

(b)    **Findings of the Court**

236    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).

237    As noted in paragraph 150 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.

238    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.

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

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

B.      **The claim in the alternative for annulment of Article 7 of the contested decision in so far as it imposes a fine on the applicants**

1.      **The plea alleging infringement of the principle of legality of criminal offences and penalties and the principle of legal certainty**

(a)    **Arguments of the parties**

241    The applicants submit that, since the fines are criminal in nature, the Commission is obliged to observe the principle oflegality of criminal offences and penalties and its corollary, the principle of legal certainty. However, in the present case, the Commission infringed both of those principles by imposing a fine on the applicants for conduct which has never before been found to be anticompetitive and which they could not have anticipated being classified as such in the future. The applicants add that it was not foreseeable that the Commission would consider Matrix to be a potential competitor to Servier.

242    The Commission refers to its response to the plea alleging infringement of Article 23(2) of Regulation No 1/2003 and concludes that the applicants should reasonably have known that the Agreement constituted a restriction of competition.

(b)    **Findings of the Court**

243    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).

244    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).

245    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).

246    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).

247    It should be added that the need for professional advice appears all the more evident where, as was the case here, it is a question of preparing and drafting an agreement intended to prevent or to settle a dispute.

248    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 Matrix, 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).

249    In particular, Matrix could assume that accepting non-marketing and non-challenge clauses, by themselves restrictive of competition, on the basis of an inducement and not the recognition of the validity of the patent, rendered the inclusion of such clauses in a patent settlement agreement entirely illegitimate and constituted abnormal use of the patent, unrelated to its specific purpose (see paragraphs 199 and 204 above). Matrix 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).

250    In addition, it must be noted that, well before the date of conclusion of the 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 and the case-law cited).

251    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).

252    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.

253    Lastly, it must be pointed out that, by the Agreement, Matrix and Servier actually decided to conclude a market exclusion agreement (see paragraphs 200 and 221 above). Although it was only in a judgment delivered after the conclusion of the 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, Matrix could not, therefore, have been unaware of the anticompetitive nature of its conduct.

254    Indeed, although, because the 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 the Agreement.

255    Moreover, the conclusion set out in paragraph 249 above cannot be called into question by the applicants’ argument alleging that the Commission’s finding of potential competition between Servier and Matrix was not foreseeable. In view of the analysis of the plea relating to the finding of potential competition between Servier and Matrix (see paragraphs 77 to 135 above) and taking into account the case-law of the Court of Justice, which allows for the gradual, case-by-case clarification of the rules on criminal liability by judicial interpretation (see paragraph 245 above), Matrix could reasonably foresee that it would be regarded by the Commission as a potential competitor of Servier. It should be added that the very presence in the Agreement of a non-marketing clause is a factor which also justifies the conclusion that Matrix saw itself as at least a potential competitor of Servier.

256    It follows from all of the foregoing that the present plea must be rejected.

2.      **The plea alleging infringement of Article 23(2) of Regulation No 1/2003**

(a)    **Arguments of the parties**

257    The applicants submit that the Commission infringed Article 23(2) of Regulation No 1/2003 since it imposed a fine on them whereas Matrix had not acted intentionally or negligently. Matrix had no intention of restricting competition, since entering into the Agreement was the only rational option available to it to limit its losses resulting from the abusive conduct of Servier, which induced Matrix’s business partner not to enter the market. Matrix was therefore the victim of Servier in the sense that it was forced by Servier to act in the way it did. Moreover, it did not act negligently, since it could not reasonably have anticipated on the date of conclusion of the Agreement that it would be found to infringe Article 101 TFEU.

258    The Commission refers to its arguments put forward in response to the plea relating to potential competition in order to submit that Matrix was in no way forced to enter into the Agreement and adds that Matrix’s claim that its intention was to limit its losses by entering into the Agreement is unsubstantiated. Moreover, it argues that the nature of the Agreement as a restriction by object, excluding an actual or potential competitor from the market in return for payment, is nothing new and that the practices of certain countries with regard to different settlements are irrelevant in the present case.

(b)    **Findings of the Court**

259    In relation to the question whether the infringements were committed intentionally or negligently and are, therefore, liable to be punished by a fine in accordance with Article 23(2) of Regulation No 1/2003, it follows from the case-law that that condition is satisfied where the undertaking concerned cannot be unaware of the anticompetitive nature of its conduct (judgments of 18 June 2013, *Schenker & Co. and Others*, C‑681/11, EU:C:2013:404, paragraph 37; of 10 July 2014, *Telefónica and Telefónica de España* v *Commission*, C‑295/12 P, EU:C:2014:2062, paragraph 156; and of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraph 762).

260    In this case, Matrix, which agreed to be paid to stay out of the market, could not have been unaware of the anticompetitive nature of that conduct.

261    An agreement which has as its object 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, according to the case-law, is ‘patently’ unlawful (see paragraph 253 above).

262    Although, because the 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 the Agreement (see paragraph 254 above).

263    The conclusion in paragraph 260 above cannot be called into question by the applicants’ other arguments.

264    In the first place, the applicants submit that Matrix was the victim of Servier in the sense that it was forced by the latter to sign the Agreement, without any possibility of resisting, which, they argue, shows that the Agreement was concluded neither intentionally nor negligently.

265    However, it has not been established that Matrix was forced in that way.

266    Indeed, the very existence of an inducive benefit, which was found in paragraph 220 above, shows that Matrix benefited from the Agreement, which contradicts the argument that Servier forced it to enter the Agreement. That argument is even less credible given that the amount of the value transfer received by Matrix, GBP 11.8 million, is significant, which is an indication of the influence that it had in the negotiation.

267    In any event, even if Servier exerted irresistible pressure on Matrix to the extent that it was forced to sign the Agreement, the latter could have reported the pressure to the competent authorities and lodged a complaint with the Commission under Article 7(2) of Regulation No 1/2003 (see, to that effect, judgments 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, paragraphs 369 and 370; of 8 December 2011, *Chalkor* v *Commission*, C‑386/10 P, EU:C:2011:815, paragraph 79; and of 6 April 1995, *Sotralentz* v *Commission*, T‑149/89, EU:T:1995:69, paragraph 53). Matrix was therefore still able to prevent the implementation of the infringement in question.

268    In the second place, the ‘prospect’ of having ‘no return on the investment ... made in trying to develop a Perindopril API’, the lack of any ‘other option but to enter the Settlement if it wanted to recoup its investment in the Perindopril project’, or the circumstance that Matrix’s intention was to ‘mitigate its losses in the Perindopril project’, could not, even if they were established, lead to the conclusion that the Agreement was not concluded intentionally or negligently. These elements show rather that Matrix’s decision to conclude the Agreement was a deliberate choice based on a cost-benefit analysis.

269    It follows from all the foregoing that the present plea must be rejected.

C.      **The claim in the further alternative for a reduction in the amount of the fine imposed on the applicants by Article 7 of the contested decision**

1.      **Arguments of the parties**

270    The applicants submit that the amount of the fine imposed on them is manifestly disproportionate to the gravity of the infringement committed, that the Commission did not take account of all the relevant circumstances of the case in assessing that gravity and that the amount of value transferred cannot serve as a reference for assessing the gravity of the infringement.

271    According to the applicants, the General Court should reduce the amount of the fine in the exercise of its unlimited jurisdiction and taking into account a number of mitigating circumstances, namely that they are an API manufacturer, like other companies that have not been penalised; unlike Niche, they had limited involvement in the discussions concerning settlements; they were a victim of Servier’s conduct; there was no viable option available to them other than entering into the Agreement; the lack of precedent and the novel nature of the imputed infringement.

272    The Commission justifies the use of the amount of value transferred on the basis of 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’), which allows it to depart from the usual methodology, in particular where, as in the present case, Matrix did not make any sales in the Union in accordance with the provisions of the Agreement. It further argues that that value was the best economic approximation of the parties’ assessment of the distortion of competition created by the Agreement. It adds that it also took account of the gravity of the infringement, Servier’s very high market share, the broad geographic scope of the Agreement, its implementation and the duration of the infringement.

273    The Commission highlights the differences between Matrix’s case and that of other API manufacturers and the fact that Matrix signed the Agreement in return for a large payment. As to the remainder, it refers to its arguments in response to the previous pleas.

2.      **Findings of the Court**

274    In the first place, as regards 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).

275    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).

276    However, it should be noted that the value chosen by the Commission in the present case for the purpose of determining the amount of the fine, namely the amount of the value transfer received by the generic undertaking, is equivalent to the cost that Servier was prepared to pay to exclude a competitor from the market and the price that the generic company was ready to accept to withdraw from the market, which, in the light of the case-law cited in paragraph 275 above, gives a reliable indication of the gravity of the infringement and the particular circumstances of the case. That value is the result of negotiations in which the generic undertaking participated and reflects the conduct of that company, the role that it played in the infringement, the benefit that it was able to gain from that infringement, and the value of the goods concerned, as estimated by the parties to the Agreement.

277    In addition, the amount of the value transfer ultimately included in the Agreement is the result of a negotiation in which the circumstances that the parties to the Agreement considered to be relevant for the purpose of determining that amount — including, as the case may be, the fact that Matrix had lost its commercial partner allowing it to enter the market — were necessarily taken into account by those parties. Those circumstances were therefore also taken into account, albeit indirectly, by the Commission when it determined the amount of the fine on the basis of that value transfer.

278    As is apparent from the foregoing considerations, the applicants are not justified in claiming that the method chosen by the Commission led it to set a fine disproportionate to the gravity of the infringement.

279    Since the applicants argue that the Commission disregarded, as such, point 20 of the Guidelines on the method of setting fines, which provides that the gravity of the infringement is to be assessed by taking account of all the relevant circumstances of the case, it must be noted that the Commission applied the provisions of point 37 of the Guidelines on the method of setting fines, which allow it to depart from the methodology set out in those Guidelines and, inter alia, in point 20 thereof. The applicants do not dispute the validity of that application. Thus, they cannot reasonably maintain that the Commission failed to comply with the provisions of point 20 of those guidelines.

280    In any event, it is appropriate to refer to the considerations set out in paragraphs 276 and 277 above, from which it is apparent that the method of calculation of the fine adopted by the Commission enabled it to take into account all the relevant circumstances of the case.

281    Lastly, even if the applicants intended to dispute the validity of the Commission’s application of point 37 of the Guidelines on the method of setting fines, it must be borne in mind that the Commission may, for the purpose of fixing the fine, have regard both to the total turnover of the undertaking, which gives an indication, albeit approximate and imperfect, of the size of the undertaking and of its economic power, and to the proportion of that turnover accounted for by the goods in respect of which the infringement was committed, which gives an indication of the scale of the infringement (judgment of 22 October 2015, *AC-Treuhand* v *Commission*, C‑194/14 P, EU:C:2015:717, paragraph 62).

282    Thus, point 13 of the Guidelines on the method of setting fines states that, ‘[i]n determining the basic amount of the fine to be imposed, the Commission will take the value of the undertaking’s sales of goods or services to which the infringement directly or indirectly … relates in the relevant geographic area within the EEA’. Those Guidelines state, in point 6 thereof, that ‘[t]he combination of the value of sales to which the infringement relates and of the duration of the infringement is regarded as providing an appropriate proxy to reflect the economic importance of the infringement as well as the relative weight of each undertaking in the infringement’.

283    It follows that point 13 of those Guidelines pursues the objective of adopting, in principle, as the starting point for the setting of the fine imposed on an undertaking, an amount which reflects the economic significance of the infringement and the relative size of the undertaking’s contribution to it (judgment of 22 October 2015, *AC-Treuhand* v *Commission*, C‑194/14 P, EU:C:2015:717, paragraph 64).

284    As can be seen from the judgment of 22 October 2015, *AC-Treuhand* v *Commission* (C‑194/14 P, EU:C:2015:717, paragraph 65), point 37 of the Guidelines on the method of setting fines states however that, ‘[a]lthough these Guidelines present the general methodology for the setting of fines, the particularities of a given case or the need to achieve deterrence in a particular case may justify departing from such methodology.’

285    In the present case, it is common ground that, by reason of the very purpose of the Agreement, which is a market exclusion agreement, Matrix was not present on that market at the time of the infringement.

286    Accordingly, the Commission was not able to use the value of sales of the product co-developed by Matrix and Niche on the relevant market during the infringement and, in particular, during the last full business year of its participation in the infringement, that is to say during the period to which reference is made in point 13 of the Guidelines on the method of setting fines.

287    Those particular circumstances entitled the Commission, on the basis of point 37 of the Guidelines on the method of setting fines, to depart from the methodology set out in those Guidelines (see, to that effect, judgments of 22 October 2015, *AC-Treuhand* v *Commission*, C‑194/14 P, EU:C:2015:717, paragraph 67, and of 6 February 2014, *AC-Treuhand* v *Commission*, T‑27/10, EU:T:2014:59, paragraphs 301 to 305).

288    The Court has, moreover, already held, in similar circumstances, that it could not seriously be disputed that, in view of the lack of sales on the market by the generic undertaking, the Commission was obliged to depart from that methodology (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 421).

289    In the second place, the mitigating circumstances invoked by the applicants cannot be accepted.

290    First, Matrix, which agreed, in return for a value transfer, to comply with non-marketing and non-challenge clauses (see paragraph 220 above), cannot be regarded as having been the ‘victim’ of Servier’s conduct. In that respect, it is appropriate to refer to the considerations set out in paragraph 264 to 266 above.

291    In any event, even if Servier had indeed exerted irresistible pressure on Matrix, to the extent that it was forced to sign the Agreement, which has not been established, Matrix could have reported that pressure to the competent authorities and lodged a complaint with the Commission under Article 7(2) of Regulation No 1/2003 (see paragraph 267 above). Since it chose not to report that infringement, the Court considers that it should not benefit from a reduction of the fine in respect of mitigating circumstances (see, to that effect, judgments 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, paragraphs 367 to 370, and of 5 October 2011, *Romana Tabacchi* v *Commission*, T‑11/06, EU:T:2011:560, paragraph 212).

292    Secondly, as regards the agreement between Servier and Azad, to which the applicants refer, it is common ground that that agreement was — unlike the agreement with Matrix — a technology transfer agreement which did not provide for any non-marketing or non-challenge clause. Those clauses are, by themselves, restrictive of competition and, where there is an inducement, reveal a sufficient degree of harm to the proper functioning of normal competition to justify a finding of a restriction by object (see paragraphs 186 and 199 above).

293    In the light of the different situations concerned, the fact that Azad, unlike Matrix, did not receive a fine does not justify the conclusion that the principle of equal treatment was infringed.

294    Thirdly, although the applicants maintain that ‘the approach adopted by the Commission is also fundamentally unfair by putting Matrix on the same footing as Niche despite the fact that Matrix had very limited involvement in the settlement discussions with Servier’, it remains the case that Matrix received an inducive value transfer amounting to GBP 11.8 million. That justifies the decision to order Matrix to pay a similar amount as a fine, since the method used by the Commission to calculate the amount of the fine, based on the amount of the value transfer, allows it — as mentioned above (see paragraph 277 above) — to assess specifically the relevant circumstances in relation to each of the agreements concluded between Servier and the generic companies, for the purpose of setting a fine, for each of those agreements, adapted to the different contexts in question. In any event, a fine less than the amount of the value transfer received by Matrix would not be sufficiently dissuasive (see paragraph 300 to 307 below).

295    Fourthly, the arguments based on the absence of any ‘other realistic practical or commercial option than to sign the Settlement’ or ‘the absence of any realistic prospect for Matrix of entering the market with its perindopril product at the time of the Settlement’, which, as is apparent from paragraph 268 above, do not exonerate Matrix from its unlawful conduct, also fail to demonstrate mitigating circumstances, since, in particular, they effectively show that the conclusion of the Agreement by Matrix was a deliberate choice based on a cost-benefit analysis.

296    Fifthly, the applicants cannot validly invoke the lack of any precedent and the novel nature of the infringement.

297    Not only could Matrix have reasonably foreseen that its conduct was caught by the prohibition laid down in Article 101(1) TFEU (see paragraph 249 above), but, moreover, it could not have been unaware of the anticompetitive nature of its conduct (see paragraphs 260 to 262 above).

298    It follows from all of the foregoing that the present plea must be rejected.

299    Moreover, there is nothing to suggest that the amount of the fine is disproportionate. There is therefore no need to reduce it.

300    In addition, it must be noted that 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 (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 (see, to that effect, judgment of 27 September 2006, *Archer Daniels Midland* v *Commission*, T‑329/01, EU:T:2006:268, paragraph 141).

301    In the present case, if the fine imposed on Matrix were set at a level below that of the inducive benefit which it enjoyed because of the infringement, the fine would not have a deterrent effect.

302    Admittedly, since the Agreement is an exclusion agreement, it entails, for the excluded generic company, a loss as regards the profits it could have made by entering the market.

303    However, that loss is the direct result of the unlawful conduct of the generic company. It is the necessary and foreseeable consequence of the choice, made by that company, not to enter the market. That loss cannot be taken into account for the purposes of reducing the amount of the fine designed to penalise the infringement.

304    Moreover, at the time a generic company is in a position to enter the market or, on the contrary, receive a value transfer not to do so, the payments that it could obtain through an agreement with an originator company are certain, whilst the profits that might result from market entry are subject to the vagaries of a commercial operation of that kind (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 432), vagaries which are all the greater in the case of an at risk entry.

305    Thus, if the amount of the fine imposed on a generic company were set at a lower level than that of the inducive benefit which it enjoyed as a result of an infringement, that company might find it preferable to conclude an agreement with an originator undertaking allowing it, even if that agreement gave rise to a penalty, to retain a part of the inducive benefit obtained from the infringement, rather than to enter the market at risk.

306    In the light of the foregoing considerations, the deterrent effect of the fine justifies the Commission’s decision not to set it at an amount less than the amount of the inducive value transfer provided for in the agreement at issue.

307    Consequently, there is no need, in any event, to reduce the amount of the fine set by the Commission.

D.      **The claim in the final alternative for annulment of Articles 2, 7 and 8 of the contested decision in so far as they concern Mylan**

1.      **The plea alleging infringement of Mylan’s rights of defence**

(a)    **Arguments of the parties**

308    The applicants accuse the Commission of having, in breach of Mylan’s rights of defence, based the liability of Mylan as a parent company on four elements of fact, which are set out in the contested decision but not mentioned in the Statement of Objections or in a supplementary Statement of Objections and which appear only in a ‘Letter of Facts’ dated 4 April 2014 sent after the Statement of Objections.

309    The Commission states that, in accordance with the case-law and the notice on best practices for the conduct of proceedings concerning Articles 101 and 102 TFEU (OJ 2011 C 308, p. 6; ‘the notice on best practices’), in particular paragraphs 110 and 111 thereof, it communicated the facts at issue to Mylan in a Letter of Facts which did not alter the objections raised in the Statement of Objections, or the intrinsic nature of the infringements described therein, including, in particular, the conclusion that Mylan exercised decisive influence over Matrix. According to the Commission, that Letter of Facts merely disclosed to the parties the new evidence on which it intended to rely in order to corroborate the existing objections and rebut the arguments raised by the applicants in the response to the Statement of Objections. The Commission adds that Mylan had the opportunity to respond and did actually respond to that Letter of Facts.

(b)    **Findings of the Court**

310    It must be borne in mind that Regulation No 1/2003 provides that the parties are to be sent a Statement of Objections which must set out clearly all the essential matters on which the Commission relies at that stage of the procedure. That Statement of Objections constitutes the procedural safeguard applying the fundamental principle of EU law which requires observance of the rights of the defence in all proceedings (see judgment of 3 September 2009, *Papierfabrik August Koehler and Others* v *Commission*, C‑322/07 P, C‑327/07 P and C‑338/07 P, EU:C:2009:500, paragraph 35 and the case-law cited).

311    That principle requires, in particular, that the Statement of Objections which the Commission sends to an undertaking on which it envisages imposing a penalty for an infringement of the competition rules contain the essential elements used against it, such as the facts, the characterisation of those facts and the evidence on which the Commission relies, so that the undertaking may submit its arguments effectively in the administrative procedure brought against it (see judgment of 3 September 2009, *Papierfabrik August Koehler and Others* v *Commission*, C‑322/07 P, C‑327/07 P and C‑338/07 P, EU:C:2009:500, paragraph 36 and the case-law cited).

312    In particular, the Statement of Objections must specify unequivocally the legal person on whom fines may be imposed, it must be addressed to that person and it must indicate in what capacity that person is called upon to answer the allegations (see judgment of 7 June 2011, *Total and Elf Aquitaine* v *Commission*, T‑206/06, not published, EU:T:2011:250, paragraph 132 and the case-law cited).

313    However, there is no provision which prevents the Commission from sending to the parties, after the Statement of Objections, fresh documents which it considers support its argument, provided that it gives the undertakings the necessary time to submit their views on the subject (judgment of 20 March 2002, *LR AF 1998* v *Commission*, T‑23/99, EU:T:2002:75, paragraph 190; see, also, to that effect, judgment of 25 October 1983, *AEG* v *Commission*, 107/82, EU:C:1983:293, paragraph 29; paragraphs 109 to 112 of the notice on best practices).

314    In the present case, Mylan was informed as from the Statement of Objections that the infringement committed by Matrix was imputed to it and was given the opportunity to respond (see paragraph 31 above). In addition, the applicants do not dispute that Mylan replied on 2 May 2014 to the Letter of Facts of 4 April 2014 concerning the imputation to Mylan of the infringement committed by Matrix and, moreover, annexed that reply to their application.

315    It cannot therefore be considered that Mylan’s rights of defence were infringed as a result of the communication of the Letter of Facts in question (see, to that effect, judgment of 8 September 2016, *Lundbeck* v *Commission*, T‑472/13, under appeal, EU:T:2016:449, paragraph 704).

316    In so far as the applicants also criticise the Commission for not sending them a supplementary Statement of Objections instead of the Letter of Facts in question, it should be noted that the communication to the parties concerned of further objections is necessary only in the event that the administrative procedure leads the Commission to take new facts into account against the undertakings or to alter materially the evidence for the contested infringements, that is to say, if additional objections are issued or the intrinsic nature of the infringement in question is altered (judgments 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 192, and of 24 May 2012, *MasterCard and Others* v *Commission*, T‑111/08, EU:T:2012:260, paragraph 268; paragraph 110 of the notice on best practices).

317    In the present case, even though certain factual information, as supported by evidence, highlighted different indicators of the exercise of decisive influence than those set out in the Statement of Objections, in order to supplement the body of evidence initially used by the Commission in the light of the replies to the Statement of Objections, it cannot be held that, in doing so, the Commission formulated additional objections against Mylan or that it changed the basis for or the extent of the imputation to it of Matrix’s infringement. The Commission merely supplemented its analysis of the organisational links between the two companies, referred to an indicator from the reply to a request for information prior to the Statement of Objections and responded to an argument made by the applicants concerning the transactions concluded between Mylan and Matrix.

318    It follows from all the foregoing that the plea alleging infringement of Mylan’s rights of defence must be rejected.

2.      **The pleas relating to the incorrect imputation of the infringement to Mylan**

(a)    **Arguments of the parties**

(1)    *Infringement of the principle of personal liability and the presumption of innocence*

319    The applicants accuse the Commission of having held Mylan liable for the infringement at issue whereas Mylan never had full ownership of Matrix’s share capital during the relevant period, since Mylan acquired a 71.5% shareholding in Matrix only approximately two years after the Agreement was entered into, it did not know and could not reasonably have known that the Agreement infringed Article 101 TFEU, in view of, inter alia, the practices at that time, in particular in Europe, and the validity of the 947 patent, and there was nothing it could have done to bring the infringement to an end. By holding it liable in those circumstances for the infringement committed by its subsidiary and without even taking account of whether it exercised decisive influence over Matrix, the Commission infringed the principle of personal liability and the presumption of Mylan’s innocence.

320    The Commission contends that the imputation of liability to Mylan as parent company for Matrix’s infringement from 8 January 2007 is explained by the fact that, from that date, Mylan exercised decisive influence over Matrix’s conduct, as shown by a number of factors mentioned in the contested decision, which enabled it, inter alia, to bring the infringement to an end. It adds that, as a large US generic company and having regard to the audit report prior to the acquisition of Matrix and decisions by US courts, Mylan should at least have suspected that accepting a significant payment for staying out of the market would raise potentially serious concerns as regards competition. Lastly, the Commission considers that the imputation of the infringement to Mylan is in accordance with the case-law concerning the imputation of infringements committed by subsidiaries to their parent companies and does not infringe the presumption of Mylan’s innocence in any way.

(2)    *The manifestly incorrect assessment of the existence of a decisive influence by Mylan over Matrix’s conduct*

321    The applicants submit that the Commission did not determine that Mylan exercised decisive influence over Matrix on the basis of concrete factual evidence.

322    First, the Commission did not take account of the fact that Matrix continued to operate as an entirely independent undertaking after the shareholding acquisitions by Mylan. In particular, neither the authorisation schedules which required Matrix to consult Mylan, which did not concern the day-to-day management of the subsidiary and were not translated into action, nor the parallel obligations to be accountable to Mylan, which were incumbent on only those employees performing purely operational functions and were not accompanied by any evidence of actual intervention by Mylan, nor the obligation to file consolidated accounts, which could only corroborate other evidence of decisive influence, are capable of demonstrating that Mylan exercised decisive influence over Matrix.

323    Secondly, the Commission wrongly considered that the board of directors was the key decision-making body of Matrix, whereas that role fell to the management committee in which no members of Mylan staff or management participated. The applicants add that the Commission wrongly inferred from the participation of two Mylan board members in Matrix’s board of directors and from the location of the meetings of that board that decisive influence was exercised over Matrix’s commercial policy, whereas, in particular, those Mylan board members did not participate in meetings in which issues regarding Matrix were discussed.

324    Thirdly, the Commission has not demonstrated that Mylan intervened in the management of Matrix’s subsidiaries, since, in particular, it identified only two interventions in that regard, which, moreover, were not capable of demonstrating that decisive influence had been exercised, and it erroneously relied on the redirection, based on commercial strategy considerations, of the activities of a wholly owned subsidiary of Matrix to a subsidiary of Mylan.

325    Fourthly, the Commission wrongly considered that transactions between Matrix and Mylan, in particular loan contracts, were not concluded under market conditions and that transactions concluded under market conditions do not, in themselves, prove the absence of decisive influence.

326    The Commission notes, as a preliminary point, that the applicants’ summary of the part of the contested decision in which Mylan’s exercise of decisive influence over Matrix is assessed is incomplete.

327    The Commission then states, first, that the exercise of decisive influence does not necessarily involve the day-to-day management of the subsidiary’s activities, that Mylan’s consent was obligatory for strategic transactions and had actually been given for some of those transactions, that Matrix’s obligation to report to Mylan enabled it to intervene if it considered that its subsidiary was acting contrary to its position, as is shown by the minutes of a meeting of Matrix’s board of directors, and that the obligation to file consolidated accounts corroborates other evidence demonstrating Mylan’s decisive influence over Matrix.

328    Secondly, the Commission considers that the simultaneous directorships between Matrix and Mylan, in particular within Matrix’s board of directors, demonstrate functional links between the two companies, which are accentuated further by the holding of some meetings of the executive bodies of Matrix, an Indian company, in the United States, where Mylan’s headquarters are located.

329    The Commission notes, thirdly, that Mylan was kept informed of the activities of Matrix’s subsidiaries, that it advised Matrix on their management and that it had imposed on Matrix a specific audit method for its subsidiaries. It adds that the applicants had still not explained what strategic advantage Matrix received from redirecting the activities of one of its subsidiaries to a subsidiary of Mylan.

330    Fourthly, the Commission reiterates that it is clear from the evidence mentioned in the contested decision that Mylan had granted Matrix three loans with favourable terms compared with those available on the market.

(b)    **Findings of the Court**

331    It must be borne in mind that, in accordance with settled case-law, the concept of an undertaking covers any entity engaged in an economic activity, regardless of its legal status and the way in which it is financed. That concept must be understood as designating an economic unit even if in law that unit consists of several natural or legal persons. When such an economic entity infringes the competition rules, it is for that entity, according to the principle of personal responsibility, to answer for that infringement (see judgments of 10 September 2009, *Akzo Nobel and Others* v *Commission*, C‑97/08 P, EU:C:2009:536, paragraphs 54 to 56 and the case-law cited, and of 19 July 2012, *Alliance One International and Standard Commercial Tobacco* v *Commission*, C‑628/10 P and C‑14/11 P, EU:C:2012:479, paragraph 42 and the case-law cited).

332    Specifically, the conduct of a subsidiary may be imputed to the parent company in particular where, although having a separate legal personality, that subsidiary does not decide independently upon its own conduct on the market, but carries out, in all material respects, the instructions given to it by the parent company, having regard in particular to the economic, organisational and legal links between those two legal entities (see judgment of 10 September 2009, *Akzo Nobel and Others* v *Commission*, C‑97/08 P, EU:C:2009:536, paragraph 58; see, also, judgment of 19 July 2012, *Alliance One International and Standard Commercial Tobacco* v *Commission*, C‑628/10 P and C‑14/11 P, EU:C:2012:479, paragraph 43 and the case-law cited).

333    In such a situation, since the parent company and its subsidiary form a single economic unit and therefore form a single undertaking for the purposes of Article 101 TFEU, the Commission may address a decision imposing fines on the parent company, without having to establish the personal involvement of the latter in the infringement (judgment of 10 September 2009, *Akzo Nobel and Others* v *Commission*, C‑97/08 P, EU:C:2009:536, paragraph 59; see, also, judgment of 19 July 2012, *Alliance One International and Standard Commercial Tobacco* v *Commission*, C‑628/10 P and C‑14/11 P, EU:C:2012:479, paragraph 44 and the case-law cited).

334    It should also be noted that, in order to be able to impute the conduct of a subsidiary to the parent company, the Commission cannot merely find that the parent company is in a position to exercise decisive influence over the conduct of its subsidiary, but must also check whether that influence was actually exercised on the basis of factual evidence, including, in particular, any management power of the parent company over its subsidiary (see, to that effect, judgments of 25 October 1983, *AEG* v *Commission*, 107/82, EU:C:1983:293, paragraph 50; of 11 July 2013, *Commission* v *Stichting Administratiekantoor Portielje*, C‑440/11 P, EU:C:2013:514, paragraph 44; and of 26 September 2013, *The Dow Chemical Company* v *Commission*, C‑179/12 P, not published, EU:C:2013:605, paragraph 67). It should be noted, in that respect, that the exercise of decisive influence by a parent company over its subsidiary’s conduct may be inferred from a body of consistent evidence, even if some of that evidence, taken in isolation, is insufficient to establish the existence of such influence (judgments of 1 July 2010, *Knauf Gips* v *Commission*, C‑407/08 P, EU:C:2010:389, paragraph 65, and of 18 January 2017, *Toshiba* v *Commission*, C‑623/15 P, not published, EU:C:2017:21, paragraph 47).

335    In the present case, the Commission considered, in the contested decision, that Matrix had to be held solely liable for the infringement in respect of the period from 8 February 2005 to 7 January 2007 and that Mylan and Matrix were jointly and severally liable for that infringement in respect of the period beginning on 8 January 2007, when Mylan increased its holding in Matrix to 71.5%, until the end of the infringement. It found that Mylan exercised decisive influence over Matrix’s commercial policy as from that date and during that period, on the basis of the following six considerations (recitals 3028 and 3045 of the contested decision).

336    First, according to the Commission, Mylan had systematic and timely access to strategic information and had influence over the decision-making processes. In particular, under ‘authorisation schedules’ put in place in March 2007, Matrix was required not only to consult Mylan before concluding business development agreements, but also to obtain the prior consent of Mylan before making certain strategic transactions. The Commission emphasised that Matrix had confirmed that Mylan was indeed consulted on significant matters. It added that some of Matrix’s senior managers had to report to Mylan, with the result that Mylan was kept informed of business developments concerning Matrix’s commercial or regulatory affairs and could intervene if the latter did not act in accordance with its guidance (recitals 3029 to 3034 to the contested decision).

337    Secondly, the Commission noted that the vice-chairman of the board of directors and chief executive officer (CEO) of Mylan was appointed as a member and non-executive chairman of Matrix’s board of directors in January 2007, had a casting vote and had expressed Mylan’s expectations as regards Matrix. Similarly, two Mylan employees, who held posts in Mylan and who had previously exercised functions in Matrix, were appointed, respectively, as non-executive vice-chairman of Matrix’s board of directors and as managing director and CEO of Matrix. The Commission added that, in addition to those three managers, additional Mylan representatives sometimes took part in Matrix’s board meetings, some of which took place in the United States between January and May 2007 (recitals 3035 and 3036 of the contested decision).

338    Thirdly, the Commission considered that Mylan’s influence over Matrix could also be inferred from Mylan’s intervention in the management of Matrix’s subsidiaries, from the advice given to Matrix concerning the management and the audit methods of its subsidiaries and from the appointment of one of Mylan’s managers to the board of directors of one of Matrix’s subsidiaries (recital 3037 of the contested decision).

339    Fourthly, the Commission found that Mylan’s obligation to file consolidated financial statements with Matrix, even if it was mandatory under US law, supports the finding that Mylan exerted decisive influence over Matrix (recital 3038 of the decision).

340    Fifthly, the Commission took the view that the fact that Matrix and Mylan concluded transactions at arm’s length was not in itself an indication that the parent company exercised no decisive influence over its majority-owned subsidiary. It also referred to three loans granted by Mylan to Matrix which were allegedly not concluded at arm’s length (recitals 3039 and 3040 of the contested decision).

341    Sixthly, the Commission noted that, as the result of a due diligence report, Mylan was aware of the Agreement at the time of its acquisition of a 71.5% shareholding in Matrix. It also considered that Mylan knew or should have known that the Agreement was a restriction of competition contrary to Article 101 TFEU, given in particular the scrutiny of similar patent settlements by the competent US authorities. The Commission added that the fact that Mylan never raised any objections to the Agreement or took any measures aimed at discontinuing Matrix’s involvement in the infringement showed that Mylan had tacitly approved the infringement, which in itself amounts to additional evidence that Mylan exercised decisive influence over the conduct of Matrix (recitals 3041 to 3044 to the contested decision).

342    The applicants contest each of the elements relied on by the Commission in the contested decision in order to establish a body of evidence demonstrating that Mylan actually exercised decisive influence over the conduct of Matrix.

343    As regards, in the first place, Mylan’s influence over Matrix’s decision-making processes, the applicants submit that Matrix continued to function as an independent undertaking after its acquisition by Mylan and complain that the Commission attached too much importance to the authorisation schedules, the obligations to report and other consultations (see paragraph 322 above).

344    It must be noted, first of all, that, according to the case-law, a — greater or lesser — degree of autonomy of a subsidiary in its own commercial management is not necessarily incompatible with the parent company’s decisive influence over that subsidiary (judgment of 12 December 2012, *1. garantovaná* v *Commission*, T‑392/09, not published, EU:T:2012:674, paragraph 48; see also, to that effect, judgments of 8 May 2013, *Eni* v *Commission*, C‑508/11 P, EU:C:2013:289, paragraph 64, and of 16 June 2011, *FMC* v *Commission*, T‑197/06, EU:T:2011:282, paragraph 122). Thus, contrary to the applicants’ submission, it cannot be inferred from the fact that Matrix continued its activities at its own premises, in its own name and maintained its management and decision-making bodies that Mylan could not or did not exercise decisive influence over its conduct (see, to that effect, judgment of 27 October 2010, *Alliance One International and Others* v *Commission*, T‑24/05, EU:T:2010:453, paragraph 222). Likewise, the fact that a subsidiary presents itself as a separate company to the outside world, as regards investors or business partners, is not sufficient to establish its autonomy (see, to that effect, as regards the conduct adopted during the administrative procedure before the Commission, judgment of 12 December 2012 in *1. garantovaná* v *Commission*, T‑392/09, not published, EU:T:2012:674, paragraph 56). Those elements of autonomy are merely the result of the fact that the subsidiary retains its separate legal personality, which does not prevent it from, as the case may be, forming an economic unit with its parent company.

345    It should be pointed out, next, that it is clear from the case-law that the obligation for the subsidiary to engage in prior consultation with the parent company or to obtain its prior approval is a strong indication that that parent company actually exercises decisive influence over its subsidiary. In particular, in a situation where the parent company must approve its subsidiary’s proposals, the fact that the subsidiary is required to obtain that approval and therefore the parent company has the right to refuse to give it is evidence of a decisive influence (see, to that effect, judgments of 27 October 2010, *Alliance One International and Others* v *Commission*, T‑24/05, EU:T:2010:453, points 183 to 187, and of 13 December 2013, *HSE* v *Commission*, T‑399/09, not published, EU:T:2013:647, paragraph 84).

346    In the present case, the applicants do not dispute the existence of those approval and consultation requirements. They do, however, contend that the approval requirements did not relate to the Agreement and concerned only exceptional matters outside day-to-day business or commercial policy and, moreover, that both the approval and the consultation requirements were never or only exceptionally implemented during the relevant period.

347    It must be borne in mind, in that respect, that the possibility of exerting decisive influence over the commercial policy of an undertaking does not require proof of interference in the day-to-day management of that undertaking’s operation, but rather influence over the general strategy which defines the orientation of the undertaking. Thus, a single commercial policy within a group may also be inferred indirectly from the totality of the economic and legal links between the parent company and its subsidiaries. For example, the parent company’s influence over its subsidiaries as regards corporate strategy, operational policy, business plans, investment, capacity, provision of finance, human resources and legal matters may have indirect effects on the market conduct of the subsidiaries and of the whole group. Ultimately, the decisive factor is whether the parent company exercises an influence that suffices to direct the conduct of its subsidiary to such an extent that the two must be regarded as one economic unit (judgment of 9 September 2015, *Toshiba* v *Commission*, T‑104/13, EU:T:2015:610, paragraph 121, and Opinion of Advocate General Kokott in *Akzo Nobel and Others* v *Commission*, C‑97/08 P, EU:C:2009:262, points 89 to 93; see also, to that effect, judgment of 26 September 2013, *The Dow Chemical Company* v *Commission*, C‑179/12 P, not published, EU:C:2013:605, paragraph 64).

348    According to the case-law, the veto rights which give the parent company control over its subsidiary are therefore those which relate to decisions on commercial strategy issues, such as the business plan or the course of action on the market, but also, in view of the need to take into account all of the economic and legal links between the parent company and its subsidiary (see paragraph 347 above), to the budget, major investments or acquisitions or the appointment of senior management (see, to that effect, judgments of 12 December 2007, *Akzo Nobel and Others* v *Commission*, T‑112/05, EU:T:2007:381, paragraph 82; of 17 May 2011, *Elf Aquitaine* v *Commission*, T‑299/08, EU:T:2011:217, paragraph 103; of 7 June 2011, *Total and Elf Aquitaine* v *Commission*, T‑206/06, not published, EU:T:2011:250, paragraph 97; and of 9 September 2015, *Toshiba* v *Commission*, T‑104/13, EU:T:2015:610, paragraph 107, upheld by judgment of 18 January 2017, *Toshiba* v *Commission*, C‑623/15 P, not published, EU:C:2017:21, paragraphs 71 and 72). In the present case, it is precisely the ‘Strategic Transactions (in the nature of joint ventures, acquisitions, major asset purchases etc.)’, which concern key strategic actions, that had to be approved by Mylan.

349    Similarly, the applicants’ argument that Mylan’s consent was not required for the conclusion of settlements, such as the Agreement, is irrelevant. The control exercised by the parent company over its subsidiary does not necessarily have to have a connection with the unlawful conduct (see judgment of 27 September 2012, *Shell Petroleum and Others* v *Commission*, T‑343/06, EU:T:2012:478, paragraph 61 and the case-law cited; see paragraph 367 below). In addition, the Commission imputed Matrix’s infringement to Mylan only as from 8 January 2007, almost two years after the conclusion of the Agreement, and thus it does not allege that Mylan gave prior approval for the signing of the Agreement.

350    As regards the allegation that the approval obligations were not implemented, it must be held that the existence of such obligations and the resulting decisive influence cannot be called into question by the fact that no strategic transaction outside the day-to-day management of the company (see paragraph 347 above) was concluded during the relevant period, which — it should be noted — lasted approximately 20 months (from 8 January 2007 to 15 September 2008) (see, to that effect, judgments of 11 July 2013, *Commission* v *Stichting Administratiekantoor Portielje*, C‑440/11 P, EU:C:2013:514, paragraphs 65, 66 and 68, and of 18 January 2017, *Toshiba* v *Commission*, C‑623/15 P, not published, EU:C:2017:21, paragraph 73). As regards the consultation obligations, it should be noted that the applicants do not advance any arguments, let alone adduce evidence, to challenge Matrix’s assertions that it consulted Mylan on important matters, as is clear from the examples of consultations which Matrix submitted to the Commission and which are referred to in recitals 3030 and 3033 of the contested decision. Moreover, the applicants merely referred to a single case in which Matrix did not consult Mylan when it should have done so and, moreover, they merely make an unsupported assertion to that effect. It is for the applicants which allege that the consultation obligations were ineffective to demonstrate this (see, to that effect, judgment of 14 March 2013, *Fresh Del Monte Produce* v *Commission*, T‑587/08, EU:T:2013:129, paragraphs 103 to 106 and the case-law cited). It may also be added that the applicants themselves referred, in their arguments relating to the obligation to report to the parent company, to a situation where Matrix consulted Mylan’s chief financial officer.

351    It should be recalled, lastly, that a flow of information between a parent company and its subsidiary and, a fortiori, an obligation to report to the parent company, also constitutes an indication of the exercise of control over the subsidiary’s decisions (see, to that effect, judgments of 20 January 2011, *General Química and Others* v *Commission*, C‑90/09 P, EU:C:2011:21, paragraph 107; of 6 March 2012, *FLSmidth* v *Commission*, T‑65/06, not published, EU:T:2012:103, paragraph 31; and the Opinion of Advocate General Mengozzi in *Evonik Degussa and AlzChem* v *Commission*, C‑155/14 P, EU:C:2015:529, point 75). Such information and reports show organisational links between the parent company and its subsidiary and allow the parent company to monitor and control the activities of its subsidiary in order to take specific measures in relation to it. It is also important to clarify that, contrary to what the applicants claim, a parent company may exercise decisive influence over its subsidiary even when it does not make use of any actual rights of supervision and refrains from giving any specific instructions or guidelines following the communication by the subsidiary of that information and those reports. Such instructions are merely a particularly clear indication of the existence of the parent company’s decisive influence over its subsidiary’s commercial policy, but the autonomy of the subsidiary cannot necessarily be inferred from their absence (judgment of 9 September 2015, *Toshiba* v *Commission*, T‑104/13, EU:T:2015:610, paragraph 121; see also, to that effect, judgment of 10 September 2009, *Akzo Nobel and Others* v *Commission*, C‑97/08 P, EU:C:2009:536, paragraph 73).

352    Moreover, it should be noted that the applicants themselves acknowledged that the reporting obligations, while limited to employees performing purely operational functions, related inter alia to commercial developments. They also did not dispute that, during the abovementioned consultation (see paragraph 350 above), Matrix sent information to Mylan concerning the ‘conversion of a finished dosage unit into an export orientated unit’ (see also recital 3034 of the contested decision). In addition, it must be noted that, given the presence of two Mylan managers at the head of Matrix’s board of directors — since the non-executive chairman and vice chairman of Matrix’s board of directors were members of Mylan’s board of directors as well as, respectively, Mylan’s CEO and head of global strategies in the office of the CEO — and the functions exercised by that board of directors, as explained by the applicants, Mylan was necessarily informed of a variety of information relating inter alia to the accounts and financial performance of its subsidiary (see, to that effect, judgments of 20 January 2011, *General Química and Others* v *Commission*, C‑90/09 P, EU:C:2011:21, paragraph 106; of 12 October 2011, *Alliance One International* v *Commission*, T‑41/05, EU:T:2011:586, paragraph 135; and of 16 September 2013, *Roca* v *Commission*, T‑412/10, EU:T:2013:444, paragraphs 72 and 74 (not published); see, also, paragraph 347 above).

353    As regards, in the second place, the organisational links between Matrix and Mylan, the applicants submit, primarily, that the Commission was wrong to infer from the composition, functions and meeting venues of Matrix’s board of directors that Mylan exercised decisive influence over the conduct of its subsidiary (see paragraph 323 above).

354    Even if the Commission had wrongly assessed the role and powers of Matrix’s Board, which would render the presence of Mylan managers on that board irrelevant for the purposes of establishing the exercise of decisive influence, nevertheless the applicants do not dispute that a Mylan manager held a leadership role, and even the main leadership role, within Matrix. A Mylan employee, who in 2007 became Mylan’s executive vice president and head of global operations, was the managing director and CEO of Matrix (see also recital 3036 of the contested decision).

355    It is apparent from the case-law that the actual exercise of management power by the parent company over its subsidiary can be shown by the presence, in leading positions of the subsidiary, of individuals holding managerial posts within the parent company. Such an accumulation of posts necessarily places the parent company in a position to have a decisive influence on its subsidiary’s market conduct since it enables members of the parent company’s board to ensure, while carrying out their managerial functions within the subsidiary, that the subsidiary’s course of conduct on the market is consistent with the line laid down at management level by the parent company (see, to that effect, judgments of 12 July 2011, *Fuji Electric* v *Commission*, T‑132/07, EU:T:2011:344, paragraphs 184 and 199; of 27 September 2012, *Nynäs Petroleum and Nynas Belgium* v *Commission*, T‑347/06, EU:T:2012:480, paragraphs 47 and 56; and of 9 September 2015, *Toshiba* v *Commission*, T‑104/13, EU:T:2015:610, paragraphs 100 and 115). It is immaterial in that regard whether, as in the present case, the director in question was appointed before Mylan’s acquisition of the shareholding in Matrix. The replacement of the former directors of that subsidiary is necessary only when those directors are not willing to follow the commercial policy advocated by the parent company. It cannot be presumed that that is always the case and it is entirely conceivable that the directors of a company would be willing to cooperate with that company’s new owner and that the latter would wish to keep them in their posts in order to avoid any disturbance to the normal business activity of the company which it has just acquired (see, to that effect, judgment of 13 December 2013, *HSE* v *Commission*, T‑399/09, not published, EU:T:2013:647, paragraphs 83, 85 and 86). It must also be borne in mind that, in the present case, the Matrix manager in question had an employment relationship with Mylan since the acquisition of the shareholding in Matrix and was seconded to Matrix by Mylan (see paragraph 354 above).

356    As regards, in the third place, the obligation to consolidate Mylan’s annual accounts with those of Matrix, the applicants submit that that obligation could only support other indicia of decisive influence and was not, by itself, capable of demonstrating the exercise of decisive influence (see paragraph 322 above).

357    It is indeed clear from the case-law, and in particular the judgment cited by the Commission in the contested decision (recital 3038), that the consolidation of the subsidiary’s annual accounts with those of the parent company does not by itself suffice for the conclusion to be drawn that that parent company exercises decisive influence over its subsidiary, but it supports that conclusion, even if that consolidation is mandatory under the applicable national law. The fact that, from an accounting perspective, a parent company presents itself and its subsidiaries towards the outside world as forming part of the same group of undertakings constitutes relevant indicia of the existence of an economic unity between them (judgments of 12 December 2012, *1. garantovaná* v *Commission*, T‑392/09, not published, EU:T:2012:674, paragraph 57, and of 13 December 2013, *HSE* v *Commission*, T‑399/09, not published, EU:T:2013:647, paragraphs 63 and 65).

358    It follows that, in the present case, having regard to the organisational, legal and personnel links between Mylan and Matrix highlighted above, the consolidation of the accounts of both companies could validly be regarded as confirming the exercise of decisive influence by Mylan over Matrix.

359    Accordingly, in the light of the foregoing findings, there is no need to examine the other indicia set out in that regard in the contested decision, the relevance of which has also been challenged by the applicants, and it must be concluded that the Commission proved to the requisite legal standard that the applicants exercised decisive influence over Matrix’s conduct, in view of the body of evidence composed solely of the following indicia, set out in the contested decision: the obligations as regards authorisation, consultation, reporting and consolidation of accounts as well as the cross-directorships between the subsidiary and its parent company.

360    It may be added, moreover, that, although the applicants challenge the relevance of the indicia based on Mylan’s intervention in the management of Matrix’s subsidiaries and the conclusion of contracts between those two companies, on which the Commission also relied in the contested decision (recitals 3037, 3039 and 3040), they do not call into question the statements made by Mylan’s representatives to Matrix’s board of directors and to its audit committee requesting Matrix to improve the management and, in particular, the presentation of accounts of its subsidiaries, or the three loans granted by Mylan to Matrix which amounted to a relatively large sum compared with Matrix’s sales. Those factors also support the finding that Mylan actually exercised decisive influence over Matrix, since the best way for Mylan to ensure the repayment of its loans is, as the Commission rightly pointed out in the contested decision (recital 3040), to exercise decisive influence over Matrix and since the abovementioned interventions by representatives of Mylan show, at the very least, a desire for budgetary control, which indicates that they are run as one (see, to that effect, judgment of 8 May 2013, *Eni* v *Commission*, C‑508/11 P, EU:C:2013:289, paragraph 64).

361    It follows from all the foregoing that the Commission correctly established and found that Mylan exercised decisive influence over Matrix’s conduct during the period from 8 January 2007 to 15 September 2008, despite the relatively short duration of that period.

362    In doing so, the Commission did not breach the principles of personal liability and the presumption of innocence.

363    The principle according to which liability for committing infringements is personal in nature, which applies to infringements of competition law, given the nature of the infringements in question and the degree of severity of the ensuing penalties (judgments of 8 July 1999, *Commission* v *Anic Partecipazioni*, C‑49/92 P, EU:C:1999:356, paragraph 78, and of 7 June 2011, *Total and Elf Aquitaine* v *Commission*, T‑206/06, not published, EU:T:2011:250, paragraph 238), must be reconciled with the concept of undertaking within the meaning of Article 101 TFEU.

364    Thus, where the economic unit infringes the competition rules, it must, according to the principle of personal liability, answer for that infringement (judgment of 17 May 2011, *Elf Aquitaine* v *Commission*, T‑299/08, EU:T:2011:217, paragraph 179). If a parent company is part of that economic unit, which may consist of several legal persons, the parent company is regarded as jointly and severally liable with the other legal persons making up that unit for infringements of competition law. Even if there is no evidence that the parent company participated directly, as a separate legal person, in the actual commission of the infringement, it exercises, in such a case, a decisive influence over the subsidiary or subsidiaries which participated directly in it. It also follows that, contrary to the applicants’ assertions, the liability of the parent company cannot be regarded as strict liability, since the parent company is one of the legal entities making up the undertaking which wrongly infringed the competition rules (judgment of 10 September 2009, *Akzo Nobel and Others* v *Commission*, C‑97/08 P, EU:C:2009:536, paragraph 77, and the Opinion of Advocate General Kokott in *Alliance One International and Standard Commercial Tobacco* v *Commission* and *Commission* v *Alliance One International and Others*, C‑628/10 P and C‑14/11 P, EU:C:2012:11, point 174).

365    Likewise, nor did the Commission infringe the principle of the presumption of innocence, which also applies to the procedures relating to infringements of the competition rules applicable to undertakings that may result in the imposition of fines, in view of the nature of the infringements in question and the nature and degree of severity of the ensuing penalties, and which entails that the Commission must show precise and consistent evidence in order to establish the existence of the infringement (see judgment of 13 December 2013, *HSE* v *Commission*, T‑399/09, not published, EU:T:2013:647, paragraph 107 and the case-law cited).

366    The imputation of the infringement in question to the parent company does not relate to the direct involvement of Mylan’s own staff or its management in the actual commission of the infringement, but to the fact that, during part of the infringement period, Mylan formed part of an economic unit with Matrix. Accordingly, it was sufficient for the Commission, in order to establish the imputation of the infringement in the present case, to prove that Mylan actually exercised decisive influence over Matrix’s conduct, and it did not have to demonstrate, in addition, that Mylan knew or should have known that the Agreement infringed Article 101 TFEU and did nothing to put an end to the infringement even though it could have done so.

367    Furthermore, although the applicants, by their arguments alleging Mylan’s lack of knowledge of the infringing nature of the Agreement and its inability to put an end to it, dispute that Mylan exercised decisive influence over Matrix’s conduct, it should be borne in mind that it is not because of a relationship between the parent company and its subsidiary in instigating the infringement or, a fortiori, because the parent company is directly involved in the infringement, but because they form a single undertaking in the sense described above that the Commission is able to address the decision imposing fines to the parent company of a group of companies (judgments of 30 September 2009, *Arkema* v *Commission*, T‑168/05, not published, EU:T:2009:367, paragraph 77, and of 2 February 2012, *EI du Pont de Nemours and Others* v *Commission*, T–76/08, not published, EU:T:2012:46, paragraph 76). The case-law therefore does not require that the parent company was aware of the infringement at that time it was committed by its subsidiary in order for that parent company to be regarded as constituting a single undertaking for the purpose of competition law and for a fine to be imposed on it on that basis (see judgment of 8 September 2016, *Merck* v *Commission*, T‑470/13, not published, under appeal, EU:T:2016:452, paragraph 445 and the case-law cited).

368    It should be added, in any event, that the applicants do not dispute that Mylan was aware of the Agreement at the time it acquired a majority shareholding in Matrix, that — as an ‘affiliate’ of Matrix — Mylan was bound by certain obligations laid down in the Agreement and that, accordingly, it could not have been unaware of the anticompetitive nature of the Agreement (see, by analogy, paragraphs 260 to 262 above). In addition, the elements put forward by the applicants to demonstrate that Mylan could not terminate the Agreement are irrelevant. First, it cannot be considered that Mylan could not put an end to the infringement because it had allegedly come to an end when Mylan acquired a majority holding in Matrix. Regardless of the arrangements for the payment of the value transfer, the Agreement was set to expire and indeed came to an end in most Member States in 2008. It may be observed, in this respect, that the applicants also do not dispute the infringement period found by the Commission corresponding to the duration of the Agreement. It cannot be inferred from the fact that Mylan’s consent was not required in order to conclude, amend or terminate settlement agreements that it was unable to bring an end to the infringement, taking into account Mylan’s actual exercise of decisive influence over Matrix which the Commission correctly established irrespective of the absence of that specific power of authorisation (see paragraphs 349 and 367 above).

369    Accordingly, all the pleas alleging the erroneous imputation of the infringement to Mylan must be rejected.

370    Since none of the pleas in law relied on by the applicants in support of their application for annulment of the contested decision is well founded or effective and since the examination of the arguments put forward in support of their application for reduction of the amount of the fine has not revealed any inappropriate elements in the Commission’s calculation of the amount of that fine, the action must be dismissed in its entirety.

**Costs**

371    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 the applicants have been unsuccessful, they must be ordered to pay, in addition to their own costs, the costs incurred by the Commission, 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 Mylan Laboratories Ltd and Mylan, Inc. to pay the costs.**

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| --- | --- | --- |
| Gervasoni | Madise | da Silva Passos |

Delivered in open court in Luxembourg on 12 December 2018.

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| E. Coulon |  | S. Gervasoni |

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| Registrar |  | President |

Table of contents

Background to the dispute

A. Perindopril

1. The compound patent

2. Secondary patents

3. Second generation perindopril

B. The applicants

C. The applicants’ perindopril activities

D. Disputes relating to perindopril

1. Dispute before the EPO

2. Disputes before the national courts

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

(b) Dispute between Servier and Apotex

E. The agreement concluded between Matrix and Servier

F. Developments after the conclusion of the Agreement

G. The Sector Inquiry

H. The administrative procedure and the contested decision

II. Procedure and forms of order sought

III. Law

A. The claim for annulment of Articles 2, 7 and 8 of the contested decision in so far as they concern the applicants

1. The plea alleging errors of law and of assessment in the analysis of potential competition on the market

(a) The criteria for assessing potential competition

(1) Arguments of the parties

(2) Findings of the Court

(b) The allegedly incorrect assessment of Matrix as a potential competitor

(1) Arguments of the parties

(i) Matrix (alone) as a potential competitor

(ii) Matrix (with Niche) as a potential competitor

(2) Findings of the Court

(i) The barriers linked to Servier’s patents

(ii) Technical difficulties

(iii) Regulatory difficulties

(iv) Financial difficulties

2. The plea alleging errors of law and of assessment in the classification of the Agreement as a restriction by object

(a) The misinterpretation and misapplication of the concept of ‘restriction by object’

(1) Arguments of the parties

(2) Findings of the Court

(i) Errors of law

– Restrictions of competition by object

– Intellectual property rights and, in particular, patents

– Patent dispute settlement agreements

– The reconciliation of patent settlement agreements and competition law

(ii) Errors of assessment

(b) Incorrect assessment of the situation that would have existed had the Agreement not been concluded

(1) Arguments of the parties

(2) Findings of the Court

3. The plea alleging errors of law and of assessment in classifying the Agreement as a restriction by effect

(a) Arguments of the parties

(1) The absence of counterfactual analysis

(2) The incorrect consideration of Servier’s dominant position

(b) Findings of the Court

B. The claim in the alternative for annulment of Article 7 of the contested decision in so far as it imposes a fine on the applicants

1. The plea alleging infringement of the principle of legality of criminal offences and penalties and the principle of legal certainty

(a) Arguments of the parties

(b) Findings of the Court

2. The plea alleging infringement of Article 23(2) of Regulation No 1/2003

(a) Arguments of the parties

(b) Findings of the Court

C. The claim in the further alternative for a reduction in the amount of the fine imposed on the applicants by Article 7 of the contested decision

1. Arguments of the parties

2. Findings of the Court

D. The claim in the final alternative for annulment of Articles 2, 7 and 8 of the contested decision in so far as they concern Mylan

1. The plea alleging infringement of Mylan’s rights of defence

(a) Arguments of the parties

(b) Findings of the Court

2. The pleas relating to the incorrect imputation of the infringement to Mylan

(a) Arguments of the parties

(1) Infringement of the principle of personal liability and the presumption of innocence

(2) The manifestly incorrect assessment of the existence of a decisive influence by Mylan over Matrix’s conduct

(b) Findings of the Court

Costs

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

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