Court of Justice of the European Communities (including Court of First Instance Decisions)

JUDGMENT OF THE GENERAL COURT (Ninth Chamber)

8 September 2016 (*)

(Competition — Agreements, decisions and concerted practices — Market for antidepressant medicinal products containing the active pharmaceutical ingredient citalopram — Concept of restriction of competition by object — Potential competition — Generic medicinal products — Barriers to market entry resulting from the existence of patents — Agreement concluded between a patent holder and a generic undertaking — Fines — Legal certainty — Principle that penalties must have a proper legal basis — 2006 Guidelines on the method of setting fines — Duration of the Commission’s investigation)

In Case T‑460/13,

Sun Pharmaceuticals Industries Ltd, formerly Ranbaxy Laboratories Ltd, established in Vadodara (India),

Ranbaxy (UK) Ltd, established in London (United Kingdom),

represented by R. Vidal, A. Penny, Solicitors, and B. Kennelly, Barrister,

applicants

v

European Commission, represented by C. Vollrath, F. Castilla Contreras and B. Mongin, acting as Agents, and by D. Bailey, Barrister,

defendant,

APPLICATION for annulment in part of Commission Decision C(2013) 3803 final of 19 June 2013 relating to a proceeding under Article 101 [TFEU] and Article 53 of the EEA Agreement (Case AT.39226 — Lundbeck) and for reduction of the amount of the fine imposed on the applicants by that decision,

THE GENERAL COURT (Ninth Chamber),

composed of G. Berardis (Rapporteur), President, O. Czúcz and A. Popescu, Judges,

Registrar: S. Spyropoulos, Administrator,

having regard to the written part of the procedure and further to the hearing on 22 October 2015,

gives the following

Judgment

 Background to the dispute

 The companies involved in the present case

1        H. Lundbeck A/S (‘Lundbeck’) is a company governed by Danish law which controls a group of companies specialising in the research, development, manufacture, marketing, sale and distribution of pharmaceuticals for the treatment of disorders in the central nervous system, including depression.

2        Lundbeck is an ‘originator’ laboratory, namely an undertaking whose activities are focused on researching new medicinal products and bringing them to the market.

3        Ranbaxy Laboratories Ltd was a company governed by Indian law specialising in the development and production of generic active pharmaceutical ingredients (‘APIs’) and generic medicinal products. On 25 March 2015, it ceased to exist, following its merger with Sun Pharmaceuticals Industries Ltd, a company governed by Indian law.

4        Ranbaxy (UK) Ltd is a company governed by English law which was a subsidiary of Ranbaxy Laboratories, responsible for the sale of the latter’s products in the United Kingdom. It is now a subsidiary of Sun Pharmaceuticals Industries.

 The relevant product and the applicable patents

5        The relevant product for the purposes of the present case is the antidepressant medicinal product containing an API known as citalopram.

6        In 1977, Lundbeck filed a patent application in Denmark for the citalopram API and two processes — an alkylation process and a cyanation process — to produce that API. Patents for that API and those processes (‘the original patents’) were issued in Denmark and in a number of western European countries between 1977 and 1985.

7        As regards the European Economic Area (EEA), the protection afforded by the original patents and, where appropriate, the supplementary protection certificates (‘SPCs’) provided for in 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), expired between 1994 (as regards Germany) and 2003 (as regards Austria). In particular, in the case of the United Kingdom, the original patents expired in January 2002.

8        Over time, Lundbeck developed other, more effective, processes for the production of citalopram, in respect of which it applied for and often obtained patents in several EEA countries and also from the World Intellectual Property Organisation (WIPO) and the European Patent Office (EPO).

9        In particular, first, in 1998 and 1999 Lundbeck applied to the EPO for two patents relating to the production of citalopram by processes using iodo and amide, respectively. The EPO granted Lundbeck a patent protecting the process using amide (‘the amide patent’) on 19 September 2001 and a patent protecting the process using iodo (‘the iodo patent’) on 26 March 2003.

10      Secondly, on 13 March 2000 Lundbeck filed a patent application with the Danish authorities relating to a process for the production of citalopram which envisaged a method of purification of the salts used by means of crystallisation. Similar applications were filed in other EEA countries and also with the WIPO and the EPO. Lundbeck obtained patents protecting the crystallisation process (‘the crystallisation patents’) in several Member States during the first half of 2002, notably on 30 January 2002 in the case of the United Kingdom. The EPO granted a crystallisation patent on 4 September 2002. In addition, in the Netherlands, Lundbeck had already obtained, on 6 November 2000, a utility model for that process, that is to say, a patent valid for six years, granted without a prior examination.

11      Lastly, Lundbeck planned to launch a new antidepressant medicinal product, Cipralex, based on the API known as escitalopram (or S-citalopram), by the middle of 2002 or the beginning of 2003. That new medicinal product was designed for the same patients as those who could be treated by Lundbeck’s patented medicinal product Cipramil, based on the citalopram API. The escitalopram API was protected by patents valid until at least 2012.

 The agreement concluded between Lundbeck and Ranbaxy Laboratories

12      In 2002 Lundbeck entered into six agreements concerning citalopram (‘the agreements in question’) with undertakings active in the production or sale of generic medicinal products (‘the generic undertakings’), including Ranbaxy Laboratories.

13      The agreement of relevance to the present case (‘the agreement at issue’), concluded between Lundbeck and Ranbaxy Laboratories, took effect on 16 June 2002, for a term of 360 days. Under an addendum signed on 19 February 2003 (‘the addendum’), that agreement was extended until 31 December 2003. The total duration of the agreement is therefore from 16 June 2002 until 31 December 2003 (‘the relevant period’).

14      According to the preamble to the agreement at issue (‘the preamble’):

–        Ranbaxy Laboratories filed two process patent applications in India relating to citalopram and manufactured medicinal products containing citalopram with the intention of marketing such products, in particular in the EEA (second and third recitals in the preamble and annex A to the agreement at issue);

–        Lundbeck performed laboratory analyses of that citalopram and concluded that the processes used infringed the amide patent and the iodo patent, the latter not having yet been granted (see paragraph 9 above), whereas Ranbaxy Laboratories disputed the existence of such infringements (fifth to eighth recitals in the preamble);

–        Lundbeck and Ranbaxy Laboratories arrived at an agreement in order to avoid costly and time-consuming patent litigation, the outcome of which could not be predicted with absolute certainty (ninth recital in the preamble).

15      According to the agreement at issue, in particular:

–        ‘Subject to the terms and conditions of this Agreement and subject to payment of the Settlement Amount by Lundbeck, [Ranbaxy Laboratories] shall not … claim any rights on the Patent Application [referred to in the preamble] or any production method used by [Ranbaxy Laboratories] and shall cancel, cease and desist from any manufacture or sale of pharmaceutical products based hereon [in particular in the European Economic Area (EEA)] during the term of this Agreement’ (Article 1.1 of the agreement at issue (‘Article 1.1’) and Article 1.0 of the addendum);

–        ‘In the event of any breach of the obligation set forth in Article 1.1 or at the request of Lundbeck’, Ranbaxy Laboratories and Ranbaxy (UK) would voluntarily submit to an interim injunction by any competent national court, without Lundbeck providing any kind of security or any undertaking other than the undertakings arising under that agreement (Article 1.2 of the agreement at issue);

–        in consideration of the agreement arrived at between the parties, Lundbeck was to pay to Ranbaxy Laboratories the sum of 9.5 million United States Dollars (USD), in instalments over the relevant period (Article 1.3 of the agreement at issue and Article 2.0 of the addendum);

–        Lundbeck was to sell Cipramil tablets (see paragraph 11 above) to Ranbaxy Laboratories or Ranbaxy (UK), with a discount of 40% on the ex-factory price, so that they could sell those tablets on the United Kingdom market (Article 1.3 of, and Appendix B to, the agreement at issue);

–        Lundbeck and Ranbaxy Laboratories undertook, during the relevant period, not to initiate legal proceedings against each other on the basis of any of the patents referred to earlier in the agreement at issue itself (Article 1.4 of the agreement at issue).

 Steps taken by the Commission in the pharmaceutical sector and administrative procedure

16      In October 2003, the Commission of the European Communities was informed of the agreements in question by the Konkurrence- og Forbrugerstyrelsen (the Danish authority for [the protection of] competition and consumers, ‘the KFST’).

17      Since most of those agreements concerned the whole of the EEA or, in any event, Member States other than the Kingdom of Denmark, it was agreed that the Commission would examine their compatibility with competition law, while the KFST would not pursue the matter.

18      Between 2003 and 2006, the Commission carried out inspections within the meaning of Article 20(4) of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles [101 TFEU] and [102 TFEU] (OJ 2003 L 1, p. 1) at the premises of Lundbeck and other companies active in the pharmaceutical sector. It also sent Lundbeck and another company requests for information within the meaning of Article 18(2) of that regulation.

19      On 15 January 2008, the Commission adopted the decision initiating an inquiry into the pharmaceutical sector pursuant to Article 17 of Regulation No 1/2003 (Case No COMP/D2/39514). The single article of that decision stated that the inquiry would relate to the introduction of innovative and generic medicinal products for human consumption on to the market.

20      On 8 July 2009, the Commission adopted a communication summarising its report of the inquiry into the pharmaceutical sector. That communication included, as a ‘technical annex’, the full version of the inquiry report in the form of a Commission working document, available only in English.

21      On 7 January 2010, the Commission opened proceedings against Lundbeck.

22      In 2010 and the first half of 2011, the Commission sent requests for information to Lundbeck and, among others, to the other companies which were parties to the agreements in question, including Sun Pharmaceuticals, Ranbaxy Laboratories and Ranbaxy (UK).

23      On 24 July 2012, the Commission opened proceedings against the generic undertakings which were parties to the agreements in question and sent them, and Lundbeck, a statement of objections.

24      All the addressees of that statement of objections who had requested a hearing made oral submissions at the hearings on 14 and 15 March 2013.

25      On 12 April 2013, the Commission sent a letter of facts to all the addressees of the statement of objections.

26      The hearing officer issued his final report on 17 June 2013.

27      On 19 June 2013, the Commission adopted Decision C(2013) 3803 final relating to a proceeding under Article 101 [TFEU] and Article 53 of the EEA Agreement (Case AT.39226 — Lundbeck) (‘the contested decision’).

 The contested decision

28      By the contested decision, the Commission considered that the agreement at issue, like the other agreements in question, constituted restrictions of competition by object for the purpose of Article 101(1) TFEU and Article 53(1) of the EEA Agreement, committed by Lundbeck and by Ranbaxy Laboratories and Ranbaxy (UK) (together ‘Ranbaxy’) (Article 1(4) of the contested decision).

29      As is apparent from the summary set out in recital 1174 of the contested decision, the Commission relied, in particular, when making that finding, on the following factors:

–        at the moment when they concluded the agreement at issue, Lundbeck and Ranbaxy were at least potential competitors in the EEA;

–        under the agreement at issue, Lundbeck transferred significant value to Ranbaxy;

–        that transfer of value was linked to Ranbaxy’s acceptance of the limitations on its entry to the market set out in that agreement, and in particular to Ranbaxy’s commitment not to manufacture or sell citalopram in the EEA during the relevant period, whether through its own subsidiaries or via third parties;

–        that transferred value considerably exceeded the profit that Ranbaxy could have expected to make by selling the generic citalopram it had manufactured until then;

–        Lundbeck could not have obtained those limitations by enforcing its process patents, since the obligations on Ranbaxy as a result of that agreement went beyond the rights granted to holders of process patents;

–        the agreement at issue contained no commitment from Lundbeck to refrain from bringing infringement proceedings against Ranbaxy if the latter entered the market with its generic citalopram after the expiry of that agreement.

30      The Commission also imposed fines on all the parties to the agreements in question. To that end, it applied 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 2006 Guidelines’). Although, in the case of Lundbeck, the Commission followed the general methodology described in the 2006 Guidelines, based on the value of sales of the product achieved by that undertaking (recitals 1316 to 1358 of the contested decision), in the case of the other parties to the agreements in question, however, namely the generic undertakings, it made use of the possibility, provided for in point 37 of those guidelines, to depart from that methodology, in view of the particularities of the case so far as those parties were concerned (recital 1359 of the contested decision).

31      Thus, as regards the parties to the agreements in question other than Lundbeck, including Ranbaxy, the Commission considered that, in order to determine the basic amount of the fine and to ensure that the fine would have a sufficient deterrent effect, it was appropriate to take account of the value of the sums transferred to them by Lundbeck pursuant to those agreements, without differentiating between the infringements on the basis of their nature or geographic scope, or on the basis of the market share of the undertakings concerned, those factors being addressed only for the sake of completeness (recital 1361 of the contested decision).

32      As regards Ranbaxy, the Commission considered that the total amount which it had received from Lundbeck corresponded to the payments provided for in the agreement at issue and the addendum thereto, that is to say, USD 9.5 million, plus the value of the 40% discount on the purchase of Cipramil from Lundbeck which Ranbaxy had been granted under that agreement (see the fourth indent of paragraph 15 above), which was estimated as amounting to GBP 3 million. When converted into euros, that total amount was EUR 12.7 million (recital 587 to the contested decision). However, in order to take account of the distribution costs incurred by Ranbaxy, the Commission applied a reduction of 10% to its turnover from the distribution of Cipramil purchased from Lundbeck (recital 1373 and footnote No 2264 to the contested decision). The basic amount was thus set at EUR 11.5 million (recital 1374 to the contested decision).

33      In view of the total length of the investigation, the Commission reduced by 10% the amount of the fines imposed on all the addressees of the contested decision (recitals 1349 and 1380 of the contested decision).

34      On the basis of those considerations, the Commission imposed a fine of EUR 10 323 000 jointly and severally on Ranbaxy Laboratories and Ranbaxy (UK) (Article 2(4) of the contested decision).

 Procedure and forms of order sought

35      By application lodged at the Court Registry on 28 August 2013, the applicants, Ranbaxy Laboratories and Ranbaxy (UK), brought the present action.

36      The written stage of the procedure was closed on 18 July 2014.

37      On 27 November 2014, in the context of the measures of organisation of procedure provided for in Article 64 of the Rules of Procedure of the General Court of 2 May 1991, the parties were invited to comment in writing on the possible consequences for the present case of the judgment of 11 September 2014 in CB v Commission (C‑67/13 P, ECR, EU:C:2014:2204).

38      The parties answered that question within the prescribed period.

39      On a proposal from the Judge-Rapporteur, the Court (Ninth Chamber) decided to open the oral part of the procedure and, by way of measures of organisation of procedure as provided for in Article 89 of its Rules of Procedure, requested the Commission to lodge a document and put a number of questions to the parties, to be answered in writing.

40      The parties complied with those measures within the prescribed period.

41      The parties presented oral argument and their replies to the questions from the Court at the hearing on 22 October 2015.

42      By letter of 9 December 2015, the applicants informed the Court of the fact that Ranbaxy Laboratories had ceased to exist following its merger with Sun Pharmaceuticals Industries.

43      The applicants claim that the Court should:

–        annul Article 1(4) of the contested decision, in so far as it concerns them;

–        annul Article 2(4) of the contested decision, in so far as it imposes a fine on them, or, in the alternative, reduce the amount of the fine;

–        order the Commission to pay the costs.

44      The Commission contends that the Court should:

–        dismiss the application;

–        order the applicants to pay the costs.

 Law

45      In support of their action, the applicants raise four pleas in law, alleging, essentially, first, that the agreement at issue does not constitute a restriction by object; secondly, manifest errors of assessment as regards potential competition; thirdly, manifest errors of assessment in the interpretation of the agreement at issue; and, fourthly, that the fine is unjustified and disproportionate.

46      It is appropriate to consider (i) the second plea in law, then (ii) the third plea in law, next (iii) the first plea in law and, lastly (iv) the fourth plea in law.

 The second plea in law, alleging a manifest error of assessment as regards potential competition

47      The applicants dispute the assessment, made by the Commission in the contested decision, that at the time of the conclusion of the agreement at issue, they had to be regarded as potential competitors of Lundbeck, in particular because the original patents had expired; they had developed their own process for the production of citalopram API; they could have obtained, in the near future, a marketing authorisation (‘MA’), within the meaning of 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); they had explored the possibility of becoming an API supplier for Lundbeck and had then sought other purchasers for their API.

48      The Commission disputes the applicants’ arguments.

49      Before examining those arguments in detail, it is necessary briefly to recall the analysis of potential competition carried out in the contested decision, in particular as regards the applicants, and to make a number of preliminary observations concerning the case-law relating to that competition, to the burden of proof and to the extent of the Court’s review.

 Analysis relating to potential competition in the contested decision

50      In recitals 615 to 620 of the contested decision, the Commission examined the specific characteristics of the pharmaceutical sector and identified two phases in which potential competition could occur in that sector.

51      The first phase may begin several years before the impending expiry of the patent on an API, when generic producers that want to launch a generic version of the medicinal product concerned begin developing viable processes leading to a product that meets regulatory requirements. Next, in the second phase, in order to prepare for actual market entry, a generic undertaking must apply for an MA, order tablets from one or more generic producers or produce them itself and find distributors or set up its own distribution network, that is to say, it must take a series of preliminary steps, without which there would never be any effective competition on the market.

52      The impending expiry of the patent on an API therefore generates a dynamic competitive process, during which the various generic undertakings compete to be the first to enter the market. The first generic undertaking to enter the market can generate significant profits, before competition intensifies and prices fall drastically. That is why generic undertakings are willing to make considerable investments and take significant risks in order to be the first to enter the market for the product concerned once the patent on the API concerned expires.

53      In those phases of potential competition, generic undertakings are often confronted with issues concerning patent law and intellectual property law. Nevertheless, they generally find a way to avoid infringing existing patents, such as process patents. They have various options in that respect, such as seeking a declaration of non-infringement or ‘clearing the way’ by informing the originator undertaking of their intention to enter the market. They may also launch their products ‘at risk’, defending themselves against any allegations of infringement or bringing a counter-claim calling into question the validity of the patents relied on in support of an infringement action. Lastly, they may also work with their API supplier in order to alter the production process or reduce the risk of infringement, or they may switch to another API producer in order to avoid such risk.

54      In recitals 621 to 623 of the contested decision, the Commission noted that, in the present case, the original patents had expired by January 2002 in most EEA countries. That had generated a dynamic competitive process, in which several generic undertakings had taken steps in order to be the first to enter the market. Lundbeck had been aware of that threat since December 1999, when it wrote in a strategic plan for 2000 that ‘by 2002 … generics [were] expected to have captured a substantial share of Cipramil sales’. Likewise, in December 2001, Lundbeck wrote in its strategic plan for 2002 that it expected that the United Kingdom market in particular would be severely hit by generic competition. Accordingly, the Commission had no doubt that the generic undertakings exerted competitive pressure on Lundbeck at the time when the agreements in question were concluded.

55      In addition, in recitals 624 to 633 of the contested decision, the Commission stated that challenging patents is an expression of potential competition in the pharmaceutical sector. It noted, in that respect, that in the EEA, generic undertakings are not required to demonstrate that their products do not infringe any patents in order to obtain an MA or to begin marketing those products. It is for the originator undertaking to prove, at least prima facie, that those products infringe one of its patents, in order to obtain a court injunction prohibiting the generic undertaking concerned from making further sales of its products on the market.

56      Finally, the Commission observed that Lundbeck’s process patents were not capable of blocking all possibilities of market entry open to the generic undertakings. In recital 635 of the contested decision, the Commission identified eight possible routes to the market:

–        first, launching the product ‘at risk’ and facing possible infringement actions brought by Lundbeck;

–        secondly, making efforts to ‘clear the way’ with the originator undertaking before entering the market, especially in the United Kingdom;

–        thirdly, requesting a declaration of non-infringement from a national court before entering the market;

–        fourthly, claiming patent invalidity before the national courts, as a counter-claim to a claim of patent infringement made by the originator undertaking;

–        fifthly, opposing a patent before the competent national authorities or the EPO and requesting that the patent be revoked or narrowed;

–        sixthly, working with the current API producer or its intermediary to change the API producers’ process in such a way as to eliminate or reduce the risk of infringement of Lundbeck’s process patents;

–        seventhly, switching to another API producer within the existing supply contract;

–        eighthly, switching to another API producer outside of the existing supply contract, either because the existing supply contract permits it or possibly because an exclusive supply contract could be invalidated if the supplied API were found to infringe Lundbeck’s process patents.

57      As regards, in particular, the examination of competition between Lundbeck and the applicants at the time of conclusion of the agreement at issue, the Commission, in recitals 1090 to 1118 of the contested decision, noted, inter alia, that the applicants:

–        had already started developing a process to manufacture citalopram in 2001;

–        had had contacts with Lundbeck in order to sell it their product;

–        had sought to sell their product to other generic undertakings, claiming that their product did not infringe any patent, and had maintained that position vis-à-vis Lundbeck, in particular at a meeting that took place on 17 April 2002;

–        had applied in India for patents concerning their process;

–        had begun taking the necessary steps to obtain an MA covering their product.

 Applicable principles and case-law

–       Potential competition

58      It must be noted that, having regard to the requirements set out in Article 101(1) TFEU regarding effect on trade between Member States and repercussions on competition, that provision applies only to sectors open to competition (see judgment of 29 June 2012 in E.ON Ruhrgas and E.ON v Commission, T‑360/09, ECR, EU:T:2012:332, paragraph 84 and the case-law cited).

59      According to the case-law, the examination of conditions of competition on a given market must be based not only on existing competition between undertakings already present on the relevant market but also on potential competition, in order 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 among themselves or for a new competitor to enter the relevant market and compete with established undertakings (judgments of 15 September 1998 in European Night Services and Others v Commission, T‑374/94, T‑375/94, T‑384/94 and T‑388/94, ECR, EU:T:1998:198, paragraph 137; 14 April 2011 in Visa Europe and Visa International Service v Commission, T‑461/07, ECR, EU:T:2011:181, paragraph 68, and E.ON Ruhrgas and E.ON v Commission, cited in paragraph 58 above, EU:T:2012:332, paragraph 85).

60      In order to determine whether an undertaking is a potential competitor in a market, the Commission is required to determine whether, if the agreement in question had not been concluded, there would have been real concrete possibilities for it to enter that market and to 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 (see judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 58 above, EU:T:2012:332, paragraph 86 and the case-law cited).

61      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 (see judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 58 above, EU:T:2012:332, paragraph 87 and the case-law cited).

62      It should, in that regard, be recalled that whether potential competition — which may be no more than the existence of an undertaking outside that market — is restricted cannot depend on whether it can be demonstrated that that undertaking intends to enter that market in the near future. The mere fact of its existence may give rise to competitive pressure on the undertakings then 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 in Visa Europe and Visa International Service v Commission, cited in paragraph 59 above, EU:T:2011:181, paragraph 169).

63      Moreover, it also follows from the case-law that the very fact that an undertaking already present on the market seeks to conclude agreements or to establish information exchange mechanisms with other undertakings which are not present on the market provides a strong indication that the market in question is not impenetrable (see, to that effect, judgments of 12 July 2011 in Hitachi and Others v Commission, T‑112/07, ECR, EU:T:2011:342, paragraph 226, and 21 May 2014 in Toshiba v Commission, T‑519/09, EU:T:2014:263, paragraph 231).

64      Although it follows from that case-law that the Commission may rely inter alia on the perception of the undertaking present on the market in order to assess whether other undertakings are potential competitors, nevertheless, the purely theoretical possibility of market entry is not sufficient to establish the existence of potential competition. The Commission must therefore demonstrate, by evidence or an analysis of the structures of the relevant market, that the market entry could have taken place sufficiently quickly for the threat of a potential entry to influence the conduct of the participants in the market, on the basis of costs which would have been economically viable (see, to that effect, judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 58 above, EU:T:2012:332, paragraphs 106 and 114).

–       The burden of proof

65      It follows from Article 2 of Regulation No 1/2003 and settled case-law that in the area of competition law, where there is a dispute as to the existence of an infringement, it is incumbent on the Commission to prove the infringements which it has found and to adduce evidence capable of demonstrating to the requisite legal standard the existence of circumstances constituting an infringement (see judgment of 12 April 2013 in CISAC v Commission, T‑442/08, ECR, EU:T:2013:188, paragraph 91 and the case-law cited).

66      In that respect, any doubt on the part of the Court must operate to the advantage of the undertaking to which the decision finding an infringement was addressed. The Court cannot therefore conclude that the Commission has established the infringement in question to the requisite legal standard if it still entertains any doubts on that point, in particular in proceedings for annulment of a decision imposing a fine (see judgment in CISAC v Commission, cited in paragraph 65 above, EU:T:2013:188, paragraph 92 and the case-law cited).

67      It is necessary to take into account the principle of the presumption of innocence resulting in particular from Article 48 of the Charter of Fundamental Rights of the European Union. Given the nature of the infringements in question and the nature and degree of severity of the penalties which may ensue, the presumption of innocence applies, inter alia, to the procedures relating to infringements of the competition rules applicable to undertakings that may result in the imposition of fines or periodic penalty payments (see, to that effect, judgment in CISAC v Commission, cited in paragraph 65 above, EU:T:2013:188, paragraph 93 and the case-law cited).

68      In addition, account must be taken of the non-negligible stigma attached to a finding of involvement in an infringement of the competition rules for a natural or legal person (see judgment in CISAC v Commission, cited in paragraph 65 above, EU:T:2013:188, paragraph 95 and the case-law cited).

69      Thus, the Commission must show precise and consistent evidence in order to establish the existence of the infringement and to support the firm conviction that the alleged infringement constitutes a restriction of competition within the meaning of Article 101(1) TFEU (see judgment in CISAC v Commission, cited in paragraph 65 above, EU:T:2013:188, paragraph 96 and the case-law cited).

70      However, it is important to emphasise that it is not necessary for every item of evidence produced by the Commission to satisfy those criteria in relation to every aspect of the infringement. It is sufficient if the set of indicia relied on by the institution, viewed as a whole, meets that requirement (see judgment in CISAC v Commission, cited in paragraph 65 above, EU:T:2013:188, paragraph 97 and the case-law cited).

71      Lastly, it must be pointed out that, when the Commission establishes that the undertaking in question has participated in an anticompetitive measure, it is for that undertaking to provide, using not only documents that were not disclosed but also all the means at its disposal, a different explanation for its conduct (see, to that effect, judgment of 7 January 2004 in 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, ECR, EU:C:2004:6, paragraphs 79 and 132).

72      Where the Commission has documentary evidence of an anticompetitive practice, it is not sufficient for the undertakings concerned to prove circumstances which cast the facts established by the Commission in a different light and thus allow another explanation of the facts to be substituted for the one adopted by the Commission. In the presence of documentary evidence, the burden is on those undertakings not merely to submit another explanation for the facts found by the Commission but to challenge the existence of those facts established on the basis of the documents produced by the Commission (see, to that effect, judgment in CISAC v Commission, cited in paragraph 65 above, EU:T:2013:188, paragraph 99 and the case-law cited).

–       The extent of the Court’s review

73      It must be borne in mind that Article 263 TFEU involves review by the EU judicature, in respect of both the law and the facts, of the arguments relied on by applicants against the contested decision, which means that it has the power to assess the evidence and annul that decision. Accordingly, whilst, in areas giving rise to complex economic assessments, the Commission has a margin of discretion, that does not mean that the Court must refrain from reviewing the Commission’s interpretation of information of an economic nature. The Court must not only establish whether the evidence put forward is factually accurate, reliable and consistent but must also determine whether that evidence contains all the relevant data that must be taken into consideration in appraising a complex situation and whether it is capable of substantiating the conclusions drawn from it (see, to that effect, judgment of 10 July 2014 in Telefónica and Telefónica de España v Commission, C‑295/12 P, ECR, EU:C:2014:2062, paragraphs 53 and 54 and the case-law cited).

74      The applicants’ arguments should be considered in the light of those principles.

 The time frame of potential competition

75      The applicants submit that, in contrast to the Commission’s assertions, in recitals 615 to 620 of the contested decision and in its pleadings before the Court, potential competition did not begin several years before the expiry of the original patents. They argue that such an approach creates a delay of eight years or more between the beginning of the competitive process and the actual market entry of competitors, which is unacceptable.

76      The Commission disputes the applicants’ arguments.

77      In that respect, it must be stated that the steps necessary for obtaining MAs and preparing for market entry constitute potential competition, when they are carried out by generic undertakings which have made significant investments in terms of human and economic resources in order to launch their generic medicinal product.

78      That potential competition is protected by Article 101 TFEU. If it were possible, without infringing competition law, to pay undertakings taking the necessary steps to prepare for the launch of a generic medicinal product, including obtaining an MA, and which have made significant investments to that end, to cease or merely slow that process, effective competition would never take place, or would suffer significant delays, at the expense of consumers, that is to say, in the present case, patients or health insurance schemes.

79      That approach is consistent with the case-law arising from the judgment of 6 December 2012 in AstraZeneca v Commission (C‑457/10 P, ECR, EU:C:2012:770, paragraph 108). The case that gave rise to that judgment concerned, inter alia, an abuse of a dominant position committed by an undertaking which had submitted misleading representations in order to obtain, from the competent national authorities, SPCs (see paragraph 7 above) allowing it to prevent the entry to the market of generic versions of its medicinal product, even after the future expiry of the patents protecting that product. In that context, the Court of Justice considered, in essence, that the anticompetitive character of those representations was not called into question by the fact that those SPCs had been requested between five and six years before their entry into force and that, until that time, the appellants’ rights had been protected by lawful patents. According to the Court of Justice, not only did such unlawful SPCs lead to a significant exclusionary effect after the expiry of the basic patents, but they were also liable to alter the structure of the market by adversely affecting potential competition even before that expiry. In that respect, it should be noted that the remark of the Court of Justice concerning the fact that potential competition begins before the expiry of the patents is independent of the fact that the SPCs at issue in that judgment had been obtained fraudulently or irregularly. Accordingly, that case-law confirms that potential competition already exists before the expiry of patents protecting a medicinal product and that the steps taken before that expiry are relevant in assessing whether that competition was restricted.

80      In the contested decision, independently of its general statements concerning the activities of API producers several years before the expiry of the patent protecting an API, the Commission carried out a detailed examination of the steps taken by the applicants in order to prepare their market entry until the signing of the agreement at issue, while placing those steps in the context that arose as a result of the fact that the original patents had expired or would soon expire in numerous EEA countries (see paragraph 7 above).

81      It follows that the Commission did not err in finding that, at the time the agreement at issue was concluded, the applicants were in a situation of potential competition with Lundbeck. Accordingly, the present arguments must be rejected, without it being necessary to rule on the extent to which the activities in which the applicants may have engaged several years before the expiry of the original patents were, by themselves, relevant.

 The minutes of the meeting of 17 April 2002 and the other evidence used by the Commission.

82      The applicants submit that the only concrete evidence on which the Commission relied in order to evaluate potential competition in the contested decision consists in the minutes, drafted by Lundbeck, of a meeting between those two undertakings that took place on 17 April 2002 (‘the minutes of 17 April 2002’). That document merely shows that the applicants intended to enter the market, not that they had the capacity to do so, and, moreover, has no probative value, since it presents only the position of exaggerated strength which the applicants wished to demonstrate to Lundbeck in the negotiations leading to the signature of the agreement at issue. The Commission ought to have examined the situation as a whole, and objectively, which would have led it to conclude that the applicants were unable to enter the market.

83      The Commission disputes the applicants’ arguments.

84      In that respect, in the first place, it is necessary to examine whether the minutes of the meeting of 17 April 2002 constitute evidence within the meaning of the case-law cited in paragraphs 69 and 70 above.

85      In that context, it must be borne in mind that, as the Commission highlighted, in particular in recital 1096 of the contested decision, it is clear from the minutes of the meeting of 17 April 2002, the text of which is quoted in recital 1095 of that decision, that, in that meeting, the applicants indicated the following to Lundbeck:

–        they had a process which did not infringe Lundbeck’s patents;

–        Lundbeck knew of that process;

–        they intended to file MA applications for the United Kingdom and Germany, where they had their own subsidiaries, and they expected to receive those MAs within eight months;

–        they were nearing conclusion of an agreement with another generic undertaking — which they did not identify, but which Lundbeck believed to be Alfred E. Tiefenbacher GmbH & Co. (‘Tiefenbacher’) or a company in the group led by group Merck KGaA — on the basis of which they would be able to bring their API to the northern Europe market within three to four months;

–        their production capacity was 4.5 tonnes of API per year worldwide;

–        they were ready to conclude an agreement with Lundbeck.

86      Likewise, it must be pointed out that, according to those minutes, Lundbeck knew that such an agreement could be costly and difficult, in particular from a competition law perspective.

87      Nevertheless, Lundbeck decided to conclude the agreement at issue, which shows that it took seriously the threat posed by the applicants according to the minutes of the meeting of 17 April 2002. Indeed, one month after that meeting, Lundbeck continued to fear that the applicants might enter the market in August 2002 through Tiefenbacher, as can be seen from the internal email of 21 May 2002, cited inter alia in recital 1097 of the contested decision.

88      In that context, it must be noted that, in accordance with the case-law cited in paragraphs 62 and 63 above, the perception that Lundbeck had of the applicants is a factor that may be taken into consideration, although it does not suffice, by itself, to demonstrate the existence of potential competition.

89      As regards the possibility that Lundbeck’s perception was affected by successful ‘bluffing’ by the applicants, it must be noted, first, that Lundbeck was an experienced undertaking which had for a long time monitored the steps taken by generic undertakings in relation to citalopram (see, inter alia, recitals 172 to 183 of the contested decision).

90      Lundbeck had monitored the applicants, in particular, especially closely, since, between January and July 2001, they had had frequent contacts, with the stated aim of exploring the possibility of Lundbeck — which was encountering difficulties in producing enough citalopram — using the applicants’ API, whereas it was in reality a delaying tactic on Lundbeck’s part (see recitals 549 to 552 of the contested decision). In addition, in May 2002, Lundbeck learned that the applicants had filed two patent applications in India and, after analysing the applicants’ reaction schemes, it considered that those applications could be in conflict with the amide and iodo patents (see recitals 560 to 564 of the contested decision).

91      Lastly, even after the agreement at issue had been signed, Lundbeck never complained that it had been the victim of a bluff; rather, as can be seen from recital 206 of the contested decision, it was delighted, in December 2002, that it had delayed the launch of generic citalopram, expected for the first quarter of 2002, which would have a positive effect on the sales development of its new medicinal product, Cipralex (see paragraph 11 above). It even wanted to extend that agreement until 31 December 2003 by signing an addendum, on 19 February 2003. In the absence of any evidence to that effect, it is not credible that the applicants could have deceived Lundbeck twice, over such a long period.

92      Moreover, it must be noted that the fact that the minutes of the meeting of 17 April 2002 were drafted by Lundbeck has no effect on their evidential value. The agreement at issue was considered to be an infringement by object committed not only by the applicants, but also by Lundbeck. Accordingly, the document in question is also disadvantageous to the latter.

93      In addition, those minutes predate the conclusion of the agreement at issue and the beginning of the Commission’s investigation and were therefore drafted in tempore non suspecto.

94      In that regard, the Court confirms the Commission’s approach, as it can be seen from the contested decision as a whole, which consisted in principally taking into account evidence prior to or contemporaneous with the date on which the agreement at issue was concluded (see, to that effect, judgment of 11 July 2014 in Esso and Others v Commission, T‑540/08, ECR, EU:T:2014:630, paragraph 75 and the case-law cited). First, the Commission cannot reconstruct the past by imagining the events that would have occurred and which did not in fact occur as a result of that agreement. Secondly, the parties to that agreement now have every interest in arguing that they had no realistic perspective of entering the market or that they thought that their products infringed one of Lundbeck’s patents. Nevertheless, it is solely on the basis of the information available to them at the time and their perception of the market at that time that they decided to adopt a particular course of conduct and concluded the agreement at issue.

95      The Commission therefore did not err in taking as its point of reference the time when that agreement was concluded in order to evaluate the competitive situation between the applicants and Lundbeck, it being noted that subsequent evidence may also be taken into account provided that it is capable of clarifying those parties’ positions at the time, confirming or casting doubt on their arguments in that respect as well as allowing a better understanding of the market concerned. In any event, that subsequent evidence cannot be decisive in the examination of the potential competition between the parties to the agreement at issue.

96      Accordingly, it must be held that the minutes of the meeting of 17 April 2002 constitute a very relevant piece of evidence on which the Commission was justified in relying.

97      In the second place, it must be noted that the Commission also took account of other factors, including the fact that the original patents had expired.

98      As regards the original patent covering the API, it must be noted that, as the Commission emphasised, in particular in recital 127 of the contested decision, in which it cited an extract of Lundbeck’s business plan for 1999, Lundbeck feared that the generic undertakings might enter the market with citalopram and compete with Cipramil after the expiry of that patent.

99      Similarly, as can be seen inter alia from recitals 150 and 634 of the contested decision, in reply to questions from the Commission prior to the notification of the statement of objections, Lundbeck acknowledged that, after the expiry of the original patents, the generic undertakings could have produced citalopram using the processes covered by those patents, even though they were not very efficient.

100    The fact that, in its reply to the statement of objections, Lundbeck changed its position is not capable of calling into question the evidential value of those factors, since that change of position occurred in tempore suspecto (see, to that effect, judgment of 8 July 2008 in Lafarge v Commission, T‑54/03, EU:T:2008:255, paragraph 509).

101    In addition, it can be seen from the documents cited in recitals 382 and 482 and from footnote No 1640 of the contested decision that Tiefenbacher considered that it was possible to produce citalopram using a process corresponding to one of the processes covered by the original patents.

102    Similarly, it follows from recital 158 of the contested decision that, in the litigation between Lundbeck and another generic undertaking, Lundbeck’s counsel acknowledged that Matrix used one of the processes covered by those patents ‘more efficiently than [they had] believed that [it] could do it’. That shows that it was possible to produce generic citalopram using the processes covered by the original patents, even though it may have been of inferior quality or more difficult to produce on an industrial scale than by using the processes covered by Lundbeck’s new patents.

103    In any event, even if it were not possible to use the processes referred to in the original patents on an industrial scale, it was still possible to adapt those processes in order to make them more efficient. In that respect, it can be seen from recital 150 of the contested decision that Lundbeck acknowledged that, between 2002 and 2004, there were several processes available to produce citalopram which were different from the process covered by the crystallisation patent.

104    In the light of those assessments from experienced undertakings in the economic sector concerned, the Commission was entitled to consider that the expiry of the original patents was an important factor in the assessment of potential competition. The fact, were it to be proved, that no generic undertaking had applied for an MA concerning the citalopram produced using the processes covered by the original patents does not call into question that finding, but signifies, at most, that those undertakings preferred to work with citalopram produced using more profitable processes.

105    As regards in particular the steps taken by the applicants in order to prepare for their market entry, first, it must be borne in mind that, as the Commission noted in recitals 550 to 552 and 1091 of the contested decision, the applicants had already begun to develop a process to develop citalopram in January 2001 and had been in contact with Lundbeck with a view to becoming an API supplier to the latter, which had encountered difficulties in producing enough. It can be seen from the document cited in recitals 552 and 1091 of the contested decision that, when, in July 2001, Lundbeck informed them that it did not wish to purchase the 400 kg of API that they had proposed, the applicants were particularly disappointed because, throughout the previous period, in the course of which Lundbeck had led them to believe that it had an interest in their API, they had deliberately waived other opportunities.

106    Secondly, in recitals 566 and 1092 of the contested decision, the Commission found, first of all, that the applicants had sent technical data concerning their API to a potential customer in Italy in December 2001, followed, in the first semester of 2002, by 16 kg of API. Next, in January 2002, a potential customer in France had also received technical data. Lastly, in 2002, the applicants had sent a small quantity of API to a potential Swedish customer.

107    Thirdly, in recitals 554, 557 and 1093 of the contested decision, the Commission found that the applicants had had contacts with the generic undertaking belonging to the holding company Arrow Group A/S (‘Arrow’), first in January 2002, and then in April 2002. Those contacts culminated in a concrete offer to Arrow concerning the sale of 500 to 1000 kg of API.

108    Fourthly, it must be recalled that the Commission also noted, in recital 1094 of the contested decision, that, on 14 June 2002, two days before the conclusion of the agreement at issue, the applicants filed, with the United Kingdom Medicines Control Agency (which was absorbed, in 2003, by the Medicines and Healthcare products Regulatory Agency; generally ‘the competent United Kingdom authority’), the Drug Master File for their API, which could constitute the basis for the filing of an MA application with that authority.

109    Lastly, it must be observed that, as the Commission pointed out in recital 584 of the contested decision, in July 2002, the applicants sold a small quantity of their API to the Italian customer with whom they had been in contact a few months earlier (see paragraph 106 above). Since the applicants were able to sell a small quantity of API just after the conclusion of the agreement at issue, they must at the very least have had real concrete possibilities to do so before then. Moreover, it must be noted that, even if — as the applicants argued at the hearing, referring to their reply to the statement of objections — sending a small quantity of API to a potential customer does not constitute an actual sale, but rather the supply of a sample, it is a preparatory step to actual sales and therefore constitutes potential competition. The applicants’ arguments that sending samples was intended only to ‘whet the appetite’ of potential customers and therefore was not a competitive action ignores the difference between potential competition and actual competition.

110    It follows that, contrary to applicants’ assertions, first, the minutes of the meeting of 17 April 2002 constitute a piece of evidence with very high evidential value and, secondly, the Commission assessed the existence of potential competition on the basis of not only those minutes, but also other relevant evidence.

111    The applicants’ arguments must therefore be rejected.

 On the period necessary for the applicants’ API to be covered by an MA

112    The applicants submit, in essence, that, despite their statements recorded in the minutes of the meeting of 17 April 2002, the Commission should not have considered that they had the possibility of obtaining, within a period of eight months, an MA for the generic citalopram produced using their processes. They also would not have been able, within a period of three to four months, to extend an existing MA belonging to other generic undertakings to that generic citalopram, since such an extension would only have been possible following a major variation of that MA, known as a ‘type II’ variation, within the meaning of Article 3 of Commission Regulation (EC) No 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State (OJ 1995 L 55, p. 7) (‘the type II variation’). In reality, those periods would have been much longer, as demonstrated by the fact that they obtained an MA only in January 2004, that is to say after the expiry of the agreement at issue. Thus, as it was impossible for them to make sales, the agreement could not restrict any competition.

113    The Commission disputes the applicants’ arguments.

114    As a preliminary point, in view of the considerations set out in paragraphs 77 to 110 above, those arguments may be rejected as ineffective.

115    First, it has been established that the steps taken by the applicants in order to prepare their market entry with generic citalopram, including as regards the procedure for obtaining MAs, were relevant for the purpose of assessing the potential competition. Secondly, those steps were taken seriously by Lundbeck, which decided to conclude an agreement with the applicants, which it perceived as a competitive threat as regards the sale of citalopram.

116    In those circumstances, it is immaterial whether the procedures necessary to obtain those MAs could have been completed in the periods envisaged by the applicants — as indicated inter alia in the minutes of the meeting of 17 April 2002 — or later.

117    In that respect, even if the applicants underestimated the period necessary in order to obtain an MA, it must be noted, first, that Lundbeck nevertheless felt competitive pressure from the applicants, to the point that it believed it to be in its interest to pay them in order to limit, or even exclude, their access to the market during the relevant period.

118    Secondly, that payment necessarily made the applicants’ need to accelerate as much as possible the procedure for obtaining an MA less pressing, since, by concluding the agreement at issue, they were ensured significant profits, given their scale, in consideration for that limitation or exclusion. The fact that, as a result of a ‘reformatting’ of the dossier, referred to by the applicants, they filed their MA request in August 2002, even though, according to the Commission’s findings in footnote No 1887 of the contested decision, all the relevant test results had been sent from India in June, confirms that they were not in any particular hurry to obtain an MA, after the conclusion of the agreement at issue.

119    Thirdly, although the success of that procedure to obtain an MA is indispensable in order for effective competition to exist, the path to obtaining such an MA, when it is taken by an undertaking which has for a long time been seriously preparing its market entry, constitutes potential competition, even though it may in fact take longer than envisaged by the interested parties.

120    In any event, in the first place, it must be noted that, according to Article 17(1) of Directive 2001/83, the Member States are to take all appropriate measures to ensure that the procedure for granting an MA for medicinal products is completed within a maximum of 210 days after the submission of a valid application. Thus, if the applicants had made a request containing all the necessary information, the competent authorities would have treated it in a period even briefer than the eight months mentioned in the minutes of the meeting of 17 April 2002.

121    It is true that the applicants submit that the period of 210 days set out in Article 17(1) of Directive 2001/83 is suspended when the competent authority considers that an application is not valid and asks the undertaking concerned to submit additional information and argue that none of the procedures for the grant of the 14 MA applications they had made between 2002 and 2004 with the competent United Kingdom authority lasted less than a year and that some lasted several years.

122    However, it must be observed that the applicants alone are responsible for how complete their MA applications are.

123    In that regard, it can be seen from the reply of another generic undertaking to a question put to it during the administrative procedure, produced before the Court, that the period for the grant of an MA concerning generic citalopram was between seven and eight months.

124    In addition, when it drafted the minutes of the meeting of 17 April 2002, Lundbeck did not insert any remark to indicate that the period of eight months envisaged by the applicants was not realistic.

125    It follows that the applicants had a real concrete possibility of obtaining an MA during the relevant period, which was sufficient, in the circumstances of the present case, to exert competitive pressure on Lundbeck.

126    In the second place, it must be recalled that the applicants acknowledge that they also had the possibility of purchasing an existing MA or of selling their API to a generic undertaking which already held an MA. Those two options required, however, that those MAs undergo a type II variation.

127    While it is true that the applicants argue that they were not interested in those possibilities, it must nevertheless be noted that, as was pointed out in paragraphs 105 to 107 and 109 above, before concluding the agreement at issue, the applicants had taken several steps to sell their API, and not to sell finished products made from that API. The fact that the sale of finished products may have been more profitable does not prevent the sale of their API being considered as a real concrete possibility for the applicants to compete with Lundbeck, as was mentioned in the minutes of the meeting of 17 April 2002.

128    As regards the applicants’ argument that the type II variation necessary for that purpose would have taken longer than the period of three to four months mentioned in those minutes, first, it must be noted that that period corresponds, in essence, to the period indicated by the applicants in their reply to the statement of objections. In that respect, it is clear that they had no reason to ‘bluff’ the Commission, as is claimed.

129    Secondly, that period corresponds to that which — according to an internal document in the Commission’s file produced before the Court — Lundbeck had envisaged as regards a type II variation that another generic undertaking could have made.

130    Thirdly, as the Commission mentioned in footnote No 1885 of the contested decision, that period of three to four months is compatible with the statistics of the competent United Kingdom authority concerning the duration of procedures relating to type II variations, which the Commission produced before the Court, from which it can be seen that, between March 2001 and February 2002, most of those procedures were completed within a period of 90 days.

131    In that respect, it is true that, as can be seen from the introductory explanations to those statistics, that period was calculated on the basis of the filing of a complete application, without taking into account suspensions due to requests for further information, which the parties also acknowledged in their written responses to a question from the Court.

132    However, as the Commission emphasised in its reply to the abovementioned question, the competent United Kingdom authority confirmed that, during the period referred to by the statistics at issue, 50% of applications submitted for type II variations were determined within a maximum period of 90 days. In 40% of cases, no request for further information was made and, in 10% of cases, the sending of such a request did not extend the procedure beyond that period of 90 days.

133    Those statistics therefore confirm that there was a real concrete possibility of varying an existing MA so that it referred to the citalopram produced in accordance with the applicants’ processes within a period of the order of that mentioned in the minutes of the meeting of 17 April 2002, since the application for a variation could fall within one of the cases referred to in paragraph 132 above.

134    Moreover, it must be noted that, although the explanations provided by the competent United Kingdom authority date from after the conclusion of the agreement at issue and even after the adoption of the contested decision, given that they were provided for the purposes of the proceedings before the Court, they refer to the situation prevailing at the time the agreement at issue was being negotiated and provide details for the interpretation of the factors set out in the contested decision. Thus, those explanations may be taken into account under the conditions referred to in paragraph 95 above.

135    Fourthly, the applicants themselves, in response to the abovementioned written question from the Court, referred to statistics of the European Medicines Agency (EMA), concerning 2002 and 2003, from which it can be seen that less than a third of applications for type II variations were dealt with in a period greater than 120 days. Those statistics confirm, under the conditions referred to in paragraph 95 above, that the period referred to in the minutes of the meeting of 17 April 2002 was a real concrete possibility that allowed, in the circumstances of the present case, competitive pressure to be exerted on Lundbeck.

136    Furthermore, the fact that the applicants had already contacted several other generic undertakings which might have been interested in their API entirely undermines their arguments, made inter alia in response to a written question from the Court, that (see paragraphs 105 to 107, 109 and 127 above) the period necessary to obtain a type II variation had to be increased in order to take account of the time necessary to find commercial partners in possession of an MA on which a type II variation could be carried out.

137    In view of the foregoing, it must be concluded that the applicants’ arguments concerning the period necessary in order to obtain an MA are ineffective (see paragraphs 114 to 119 above) and, in any event, unfounded, since they do not call into question the fact that the minutes of the meeting of 17 April 2002 mention real concrete possibilities of obtaining an MA enabling the market launch of the citalopram manufactured using the applicants’ process.

 The presumption of validity of the amide and iodo patents

138    The applicants submit that they had significant doubts concerning the compatibility of their process with the amide and iodo patents, which enjoyed a presumption of validity. Thus, they argue that the Commission did not prove that, if they had not concluded the agreement at issue, they would have entered the market at their own risk.

139    The Commission disputes the applicants’ arguments.

140    As a preliminary point, it must be borne in mind that the Court of Justice has indeed acknowledged that the specific purpose of industrial property is, inter alia, to ensure that the patentee, 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 in Centrafarm and de Peijper, 15/74, ECR, EU:C:1974:114, paragraph 9). However, it has also established 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 fall within the prohibitions contained in that article. This may be the case whenever the exercise of such a right appears to be the object, the means or the consequence of an agreement, decision or concerted practice (see, to that effect, judgment in Centrafarm and de Peijper, EU:C:1974:114, paragraphs 39 and 40).

141    Likewise, the Court of Justice has established that although the Commission is not competent to determine the scope of a patent, 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 Articles 101 and 102 TFEU (judgment of 25 February 1986 in Windsurfing International v Commission, 193/83, ECR, EU:C:1986:75, paragraph 26). In the same judgment, the Court stated that the specific subject matter of the patent cannot be interpreted as also affording protection against actions brought in order to challenge its validity (judgment in Windsurfing International v Commission, EU:C:1986:75, paragraph 92).

142    In the light of the principles deriving from that case-law, the presumption of validity enjoyed by all patents cannot be equated with a presumption of illegality of generic products placed on the market which the patent holder deems to be infringing the patent. Accordingly, in the present case, it was for Lundbeck to prove before the national courts, in the event that generic medicinal products entered the market, that they infringed one of its process patents, since entry ‘at risk’ by a generic undertaking is not in itself unlawful. Moreover, in the context of an infringement action brought by Lundbeck against the generic undertakings, those undertakings could have contested the validity of the patent on which Lundbeck relied by raising a counter-claim. Such claims occur frequently in patent litigation and lead, in numerous cases, to a declaration of invalidity of the process patent relied on by the patent holder, as the Commission noted in recital 76 of the contested decision. For example, it can be seen from the evidence set out in recitals 157 and 745 of the contested decision that Lundbeck itself estimated the probability that its crystallisation patent would be held invalid at 50 to 60%.

143    Thus it is appropriate to examine whether the Commission proved that the applicants, after taking numerous steps in order to prepare for their market entry with citalopram in several EEA countries in the near future (see paragraphs 90, 105 to 107 and 109 above), were ready, at the time the agreement at issue was concluded, to run the risks involved in such an entry, if Lundbeck had not paid them to stay out of the market, by guaranteeing them, through that agreement, a return on the investments already made, without the applicants having to take the slightest risk.

144    In that respect, first, it must be noted that the applicants themselves acknowledge that, before concluding the agreement at issue, they believed that it was possible they would succeed in litigation with Lundbeck, in the context of an infringement action based on the amide and iodo patents. While it can be accepted that there were no certainties in that regard, it must nevertheless be borne in mind that, both during the meeting of 17 April 2002 and in the preamble to the agreement at issue, they maintained that their processes did not infringe Lundbeck’s patents. In particular, it must be noted that, as can be seen from inter alia the eighth and ninth recitals in the agreement at issue, the applicants have never admitted that the processes that they used, which corresponded to their patent applications in India, infringed Lundbeck’s intellectual property rights; rather, they wished to avoid litigation the outcome of which could not be foreseen with absolute certainty.

145    Secondly, it must be observed that the fact that, in the present case, Lundbeck agreed to conclude an agreement providing for payments from Lundbeck to the applicants constitutes a relevant piece of evidence which, in combination with the other evidence referred to above, proves that Lundbeck was not certain that it would succeed in the event of litigation. The applicants also acknowledge that there was uncertainty in that respect, even though they argue that that uncertainty was not sufficient to establish that they were potential competitors of Lundbeck. In view of those considerations, which are in accordance with the principles deriving from the case-law cited in paragraph 63 above, the Court can reject the applicants’ argument — formally set out in the context of the third plea in law, but which it is appropriate to deal with here — by which they dispute that the fact that Lundbeck paid them a total amount equivalent to EUR 12.7 million justifies the conclusion that Lundbeck doubted that it would succeed in litigation to demonstrate that the applicants’ citalopram infringed its amide and iodo patents and to confirm the validity of those patents.

146    In that respect, it is indeed true that Lundbeck, from January 2002, had begun to bring legal actions against generics undertakings, as the applicants submit. However, it did so, as the Commission emphasises, in reaction to the market entry of APIs allegedly produced in breach of the crystallisation patent, as can be seen from recital 185 of the contested decision, whereas the processes used by the applicants could only have infringed the amide and iodo patents. In any event, besides the fact that it was not certain that Lundbeck would seek injunctions against the applicants, it was even less certain that, even if it did so, it would obtain those injunctions. As is clear from that recital and from footnotes No 389 and 390 of the contested decision, several applications for interim measures made by Lundbeck against other generic undertakings had been rejected.

147    Thirdly, as regards the applicants’ argument that they were particularly worried about the iodo patent on the ground that it had not yet been granted and that they did not yet know its exact scope, it must be observed, as the Commission points out, that, for that same reason, the applicants could not be certain that that patent would be granted and that their processes infringed that patent.

148    Fourthly, it can be seen, inter alia, from recital 1105 of the contested decision, that before and after the conclusion of the agreement at issue, the applicants stated to third parties that their processes did not infringe Lundbeck’s new patents. It is not credible that they would have deliberately given false information to their potential customers with the aim of convincing them to purchase their API. Such conduct would have exposed them to actions for damages brought by those customers. Moreover, one of those customers had received from the applicants all the documentation necessary to support the fact that their processes were not infringing.

149    Fifthly, while it is true that an at risk market entry would have exposed the applicants to the possibility of having to pay damages to Lundbeck, it is also true that a rapid market entry could have entailed significant profits. Since the applicants had been preparing for their market entry for a long time and since they had not halted their steps to that end when the agreement at issue was signed, it cannot be considered that, if that agreement had not been concluded and the applicants had not received the payments provided for therein, they would have given up on their plan.

150    Sixthly, the applicants’ argument that the Commission relied solely on subjective elements must be rejected. It is principally on the basis of documents from, inter alia, the period prior to the conclusion of the agreement at issue, the text of that agreement and the conduct of the parties to that agreement that the Commission assessed whether the applicants had real concrete possibilities of entering the market (see paragraphs 82 to 110 above). Furthermore, in any event, the taking into account of subjective elements, such as Lundbeck’s perception, provided that it can be established on the basis of objective evidence, is in accordance with the case-law (see paragraphs 63 and 64 above).

151    In view of those considerations, the applicants’ present arguments must be rejected.

 The applicants’ remaining arguments

152    In the first place, the applicants submit that, even after the relevant period, they preferred to conclude a licence agreement with Lundbeck rather than enter the market with their own product, which confirms their fears concerning the infringement of the amide and iodo patents.

153    The Commission disputes that argument.

154    First, it must be noted that the licence agreement invoked by the applicants was concluded after the conclusion of the agreement at issue, with the result that it can be taken into account only under the conditions referred to in paragraph 95 above.

155    Secondly, as the Commission submits, the fact that, in January 2004, the applicants may have requested a licence from Lundbeck concerning the iodo patent does not mean that, because of the fear of infringing that patent, they could not have entered the market earlier, instead of concluding the agreement at issue. That patent was not granted until 23 March 2003. In addition, the Commission states that, in January 2004, the applicants had threatened to bring litigation concerning the iodo patent in the United Kingdom, as can be seen from the documents produced by the Commission in response to a written question from the Court. In those circumstances, the applicants could assume that Lundbeck would agree to grant them a licence at a reduced price, which allowed them to protect themselves, at low cost, from any risk of potentially infringing the iodo patent.

156    Accordingly, the licence agreement invoked by the applicants is not capable of calling into question the Commission’s conclusion that the applicants were potential competitors of Lundbeck at the time the agreement at issue was concluded.

157    In the second place, the applicants submit that the fact that, after the expiry of the agreement at issue, they waited five more months before entering the market shows that they were not able to do so at the time they signed that agreement. In their view, the Commission has not proved that, as a result of that agreement, their preparations to enter the market slowed.

158    The Commission disputes those arguments.

159    It must be noted that the arguments raised by the applicants confuse the concepts of potential competition and actual competition, and can therefore be rejected in view of the considerations set out in paragraphs 77 to 81 above.

160    Developing the line of reasoning set out in paragraphs 77 to 81 above, it must be noted that, as the Commission rightly submits, in the absence of the agreement at issue, the applicants could have sought, in 2002, to be one of the first generic undertakings to sell generic citalopram, as rational economic operators attracted by the prospect of the significant profits which such an early entry entailed. In that respect, the applicants themselves, in their reply to the statement of objections, acknowledged that, after the expiry of the agreement at issue (on 31 December 2003), other generic undertakings had already acquired 80% of the market, which implied that the level of profitability of the generic version of citalopram was well below that of 2002, as the Commission emphasised in recital 211 of the contested decision. That decline in profitability greatly reduced the applicants’ incentive to enter the market as fast as possible after the agreement had come to an end.

161    Accordingly, the actual date on which the applicants’ entered the market is not a reliable indicator of the existence of potential competition at the time the agreement at issue was concluded, with the result that the present argument can be rejected.

162    Since the above considerations are sufficient to justify the conclusion that the applicants had real concrete possibilities of entering the market with their API within a sufficiently short period to be characterised as potential competitors of Lundbeck, it is not necessary to rule on their arguments concerning the possibility that they could develop other processes.

163    In the light of all of the foregoing, the second plea must be rejected.

 The third plea in law, alleging manifest errors of assessment in the interpretation of the agreement at issue

164    In the context of the third plea in law, the applicants criticise, inter alia, the allegedly broad interpretation of the agreement at issue in the contested decision, according to which that agreement enabled Lundbeck, in return for high payments, to obtain much more that it would have been able to obtain by enforcing its amide and iodo patents.

165    The Commission disputes the applicants’ arguments.

166    It is appropriate to begin the examination of the present plea in law by recalling that the obligations undertaken by the applicants under the agreement at issue are those set out in Article 1.1 of that agreement, which provides as follows:

‘Subject to the terms and conditions of this Agreement and subject to payment of the Settlement Amount by Lundbeck, [Ranbaxy Laboratories] shall not … claim any rights on the [p]atent [a]pplication [referred to in the preamble] or any production method used by [Ranbaxy Laboratories] and shall cancel, cease and desist from any manufacture or sale of pharmaceutical products based hereon [in particular in the EEA] during the term of this Agreement …’

167    In recital 1121 of the contested decision in particular the Commission interpreted Article 1.1 as meaning that the applicants had accepted not to make or sell citalopram, whether in the form of API or medicinal products, in the EEA for the term of the agreement, irrespective of the production method used.

168    The applicants submit that that interpretation is incorrect and that the obligations deriving from Article 1.1 give rise to the same situation as that which would have existed if Lundbeck had brought legal actions against the applicants on the basis of its patents and had succeeded in each action.

169    In particular, they submit that the Commission did not take sufficient account of the fact that the agreement at issue was subject to Swedish law and that it misinterpreted the expressions ‘any production method used by Ranbaxy’ and ‘pharmaceutical products’ in Article 1.1.

 The relevance of the fact that the agreement at issue is subject to Swedish law

170    According to the applicants, the Commission did not take account of the legal principles of Swedish law concerning the interpretation of contracts, whereas the agreement at issue is subject to that law. As a matter of Swedish law, all contractual interpretation must be based on the text itself, as well as the preamble and the parties’ intentions. Particular regard must be had to the meaning which, in the industry and the regulatory context concerned, is normally attributed to the terms used in the contract in question.

171    The Commission disputes the applicants’ arguments.

172    First, it must be borne in mind that a question relating to the interpretation of the national law of a Member State is a question of fact (see, to that effect and by analogy, judgments of 21 December 2011 in A2A v Commission, C‑318/09 P, EU:C:2011:856, paragraph 125 and the case-law cited, and 16 July 2014 in Zweckverband Tierkörperbeseitigung v Commission, T‑309/12, EU:T:2014:676, paragraph 222 and the case-law cited) in respect of which the Court is required, in principle, to carry out a comprehensive review (see paragraph 73 above).

173    Secondly, it must be observed that, according to an opinion from a Swedish law firm produced by the applicants, in Swedish law, the starting point for all interpretation is the text of the agreement itself, the terms used must be read in their context and the intention of the parties may be relevant. While it is true that that opinion mentions the possibility that, in order to take account of the parties’ intentions, a text may be interpreted contrary to its wording, it nevertheless adds that that interpretative criterion is very rarely applied. In addition, it must be noted that, in the circumstances of the present case, it is obvious that the parties have, at present, every interest in presenting the agreement at issue in such a way as to reduce the probability that it constitutes a restriction of competition.

174    The applicants’ arguments concerning the interpretation of the two abovementioned provisions must be examined in the light of those principles, the substance of which is not disputed by the Commission.

 The meaning of the phrase ‘any production method used by Ranbaxy’

175    In recitals 1131 to 1137 of the contested decision, inter alia, the Commission concluded that the expression ‘any production method used by Ranbaxy’ covered not only the method that the applicants had when they concluded the agreement at issue, but also the methods that they might develop subsequently, during the relevant period.

176    The applicants dispute that interpretation and submit that that phrase covers only the processes which the applicants already had when the agreement at issue was concluded.

177    As regards the wording of that article, it must be noted that the use of the expression ‘any … method’ permits, in itself, the view that it did not concern only the methods already used by the applicants when they signed that agreement and that the methods that they might develop subsequently were also covered, as the Commission found in the contested decision.

178    It is necessary, however, to verify whether other factors arising from the agreement at issue itself or from the context in which it was concluded undermine that interpretation.

179    In that respect, first, the applicants submit that the preamble refers to the patent applications that it filed in India (third recital) as well as Lundbeck’s belief, based on the results of laboratory analyses, that those applications related to processes which infringed its amide and iodo patents (fifth to seventh recitals).

180    However, those are factors which explain the context in which the agreement at issue took place but do not suffice to call into question the fact that, in the light of its clear wording, Article 1.1 does not contain restrictions concerning the processes covered by the obligations undertaken by the applicants. If the parties to that agreement had intended to restrict the scope of those obligations to the processes corresponding to the applicants’ patent applications, they could have chosen suitable wording for that purpose, instead of choosing very broad wording, whose scope has to be restricted by an interpretation in the light of the preamble.

181    Secondly, the context in which the agreement at issue was concluded confirms the interpretation of Article 1.1 set out in paragraph 177 above. As the Commission noted, in essence, inter alia in recitals 130 to 132, 140, 204 and 206 of the contested decision, without being contradicted by the applicants, Lundbeck wished to delay the entry of generic citalopram on the market, in order to create the best possible conditions for the launch of its new medicinal product, Cipralex, which contained a patent-protected API (see paragraph 11 above).

182    In the light of that objective, it is inconceivable that Lundbeck would have agreed to pay the applicants the amounts provided for in the agreement at issue, if that agreement had allowed them to produce and sell generic citalopram using processes other than those covered by their patent applications filed in India. In reality, Lundbeck would not have concluded a costly agreement if it had not brought certainty that the applicants would keep out of the market with their generic citalopram during the relevant period, during which Lundbeck planned to begin to market Cipralex.

183    While it is true that the applicants did not have the same objective as Lundbeck as regards Cipralex, they nevertheless could not have failed to have been aware of it, particularly since they had a clear interest in obtaining specific sums from Lundbeck rather than taking the risks that their market entry would have entailed, like any commercial operation.

184    It follows from the foregoing that the Commission did not err in finding that the obligations accepted by the applicants under Article 1.1, read also in the light of their context, were not limited to citalopram produced in accordance with the processes that they were using at the time the agreement at issue was signed.

185    Accordingly, the arguments put forward by the applicants must be rejected, without it being necessary to rule on the merits of the Commission’s finding in recital 1133 of the contested decision, according to which the phrase ‘during the term of the Agreement’, at the end of the long sentence in the agreement at issue cited in paragraph 166 above, refers to ‘any production method used by Ranbaxy’, which the applicants dispute.

 The meaning of the phrase ‘pharmaceutical products’

186    In recitals 1125 to 1130 of the contested decision, the Commission, by rejecting an argument put forward by the applicants in response to the statement of objections, interpreted the phrase ‘pharmaceutical products’, in Article 1.1, as meaning that it included not only the citalopram-based finished products, but also that API itself and bulk products containing that API.

187    The applicants dispute that interpretation by referring to the preamble, arguing that it can be understood from that preamble that the word ‘citalopram’ is used to refer to the API, whereas the phrase ‘pharmaceutical products’ refers to finished products containing that API.

188    In that regard, first, as the Commission rightly submits, it must be noted that, if the parties to the agreement at issue had wished to limit the applicants’ commitment to finished products alone, they would have expressly stated so.

189    Secondly, it does not follow from the contested decision that Lundbeck considered that the phrase ‘pharmaceutical products’ in paragraph 1.1 had the limited scope that the applicants seek to attribute to it.

190    Thirdly, it must be recalled that, as the Commission pointed out in recital 568 of the contested decision, on 14 June 2002, Lundbeck sent the applicants, which had already signed the agreement at issue on 11 June 2002, a cover letter to that agreement (‘the cover letter’), which was worded as follows:

‘The Agreement is signed by Lundbeck and returned to Ranbaxy subject to the explicit proviso that the term ‘‘pharmaceutical products” also covers bulk and any other form containing the active ingredient and that products delivered to Ranbaxy under Article 1.3 are only for sale in the UK.’

191    The applicants signed the cover letter of 17 June 2002, after Lundbeck had signed the agreement at issue on 16 June 2002.

192    The cover letter therefore had the objective of making it even more explicit that the obligations accepted by the applicants under the agreement at issue also covered citalopram in bulk form and in any other form containing the API in question. It must be pointed out that such a broad wording also includes the API itself.

193    In addition, while it is true that the meaning of the terms ‘bulk products’ in the pharmaceutical sector may refer to unpackaged finished products, as the applicants submit, nevertheless, the term ‘bulk’ may be used to refer to an API, as can be seen, inter alia, from the letter that Lundbeck sent to the applicants on 14 January 2001, produced before the Court, and from the applicants’ website itself, as the Commission mentioned in its written pleadings before the Court, and which the applicants have not denied.

194    Fourthly, the interpretation of the phrase ‘pharmaceutical products’ proposed by the applicants is not effectively supported by their argument that they sold or sought to sell their API during the relevant period, while confirming to Lundbeck that they had respected the agreement at issue, which — according to the applicants — gives rise to the conclusion that that agreement did not impose any obligation on them concerning the API.

195    In that respect, it is indeed true that, as the Commission stated in recital 584 of the contested decision, in July 2002, that is to say during the relevant period, the applicants sold 2.5 kg of their API to an Italian company. However, as the Commission rightly submits, first of all, that quantity is very small by comparison with the 500 kg of API that the applicants had when the agreement at issue was concluded. Moreover, that sale took place soon after the signing of that agreement, with the result that it is entirely possible that a sales representative fulfilled an order made previously. Lastly, and above all, the applicants hid that sale from Lundbeck, since, in the email of 25 October 2002 cited in recital 577 of the contested decision, they wrote the following to Lundbeck:

‘This is to confirm that we have not sold any citalopram, not only in Europe but in the entire world after June [20]02.’

196    In that regard, the Court finds that the applicants’ arguments alleging that, in the context of that email, the term ‘citalopram’ must be understood as meaning ‘finished products containing citalopram’, and that the information provided to Lundbeck is therefore consistent with their conduct, are not credible. That meaning of the term citalopram proposed by the applicants contradicts the meaning that they invoke when that term is used in the agreement at issue, where, in their submission, it means ‘API’, and not ‘finished products’ (see paragraph 186 above).

197    As regards the fact that the applicants had contacts with Arrow, which was possibly interested in the purchase of their API, it must be noted that most of those contacts took place before the relevant period, as can be seen from recitals 554, 557 and 1093. In addition, it must be noted that, in fact, the applicants did not sell API to Arrow and have not explained why those contacts were unsuccessful. Moreover, it must also be taken into account that Arrow had also concluded an agreement with Lundbeck, intended to limit its market entry with generic citalopram.

198    In view of the foregoing, it must be concluded that the Commission did not err in considering that the phrase ‘pharmaceutical products’, in Article 1.1, should be interpreted as covering citalopram in any form whatsoever.

199    The applicants’ arguments in that regard must therefore be rejected.

200    The other arguments put forward by the applicants in the context of the present plea in law, concerning the payments provided for in the agreement at issue, were rejected in part in the examination of the second plea in law (see paragraph 145 above) and will be examined, as to the remainder, in the context of the first plea in law. Since those arguments concern, in essence, the role of the payments provided for in the agreement at issue and the allegedly pro-competitive effects of that agreement, they raise questions inherent to the existence, in the present case, of a restriction by object for the purpose of Article 101 TFEU, which is precisely the subject matter of the first plea in law.

201    In the light of the foregoing, the third plea in law must be rejected, subject to the examination of the arguments referred to in paragraph 200 above.

 The first plea in law, alleging that the agreement at issue is not a restriction by object

202    The applicants submit that, in view, in particular, of the allegedly criminal nature of the sanctions provided for in EU competition law and the fundamental rights that must be respected in that regard, the concept of restriction by object must be interpreted strictly and thus be applied only to conduct the anticompetitive effect of which is obvious on the basis of previous experience. The need for such a strict interpretation is explained, according to the applicants, by the fact that the classification of an agreement as a restriction by object leads to a reversal of the burden of proof, and even to a presumption that is irrebuttable in practice. The agreement at issue does not correspond to that concept and the Commission therefore ought to have assessed its effects before concluding that it was contrary to Article 101(1) TFEU.

203    In their written reply to the Court’s question concerning the judgment in CB v Commission, cited in paragraph 37 above (EU:C:2014:2204), the applicants emphasised that that judgment confirmed the need to interpret the concept of restriction by object strictly and to apply it only to agreements the actual — and not merely the potential — anticompetitive nature of which is easily identifiable, on the basis of previous experience, which is not the position in this case.

204    The Commission disputes the applicants’ arguments.

205    Before examining the applicants’ arguments in further detail, it is necessary to make some preliminary observations on, inter alia, the judgment in CB v Commission, cited in paragraph 37 above (EU:C:2014:2204), and briefly to recall the analysis relating to the existence of a restriction of competition by object carried out in the contested decision.

 Preliminary observations

206    It must be recalled that Article 101(1) TFEU provides as follows:

‘The following shall be prohibited as incompatible with the internal market: 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, and in particular those which:

(a)      directly or indirectly fix purchase or selling prices or any other trading conditions;

(b)      limit or control production, markets, technical development, or investment;

(c)      share markets or sources of supply;

(d)      apply dissimilar conditions to equivalent transactions with other trading parties, thereby placing them at a competitive disadvantage;

(e)      make the conclusion of contracts subject to acceptance by the other parties of supplementary obligations which, by their nature or according to commercial usage, have no connection with the subject of such contracts.’

207    In that regard, it is clear from the case-law that certain types of coordination between undertakings reveal a sufficient degree of harm to competition for the examination of their effects to be considered unnecessary (judgment in CB v Commission, cited in paragraph 37 above, EU:C:2014:2204, paragraph 49; see also, to that effect, judgments of 30 June 1966 in LTM, 56/65, ECR, EU:C:1966:38, pp. 249 and 250, and 14 March 2013 in Allianz Hungária Biztosító and Others, C‑32/11, ECR, EU:C:2013:160, paragraph 34).

208    That case-law arises from the fact that certain forms of coordination between undertakings can be regarded, by their very nature, as being injurious to the proper functioning of normal competition (judgment in CB v Commission, cited in paragraph 37 above, EU:C:2014:2204, paragraph 50; see also, to that effect, judgment in Allianz Hungária Biztosító and Others, cited in paragraph 207 above, EU:C:2013:160, paragraph 35 and the case-law cited).

209    Consequently, it is established that certain collusive behaviour, such as that leading to horizontal price-fixing by cartels or consisting in the exclusion of some competitors from the market, may be considered so likely to have negative effects, in particular on the price, quantity or quality of the goods and services, that it may be considered redundant, for the purposes of applying Article 101(1) TFEU, to prove that they have actual effects on the market. Experience shows that such behaviour leads to falls in production and price increases, resulting in poor allocation of resources to the detriment, in particular, of consumers (judgment in CB v Commission, cited in paragraph 37 above, EU:C:2014:2204, paragraph 51; see also, to that effect, judgment of 20 November 2008 in Beef Industry Development Society and Barry Brothers, C‑209/07, ECR, ‘the BIDS judgment’, EU:C:2008:643, paragraphs 33 and 34).

210    Where the analysis of a type of coordination between undertakings does not reveal a sufficient degree of harm to competition, the effects of the coordination should, on the other hand, 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 (judgments in Allianz Hungária Biztosító and Others, cited in paragraph 207 above, EU:C:2013:160, paragraph 34, and CB v Commission, cited in paragraph 37 above, EU:C:2014:2204, paragraph 52).

211    In order to establish the anticompetitive nature of an agreement and assess whether it reveals a sufficient degree of harm to competition that it may be considered a restriction of competition by object for the purpose 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 a part. When determining that context, it is also necessary to take into consideration the nature of the goods or services affected, as well as the real conditions of the functioning and structure of the market or markets in question (judgments in Allianz Hungária Biztosító and Others, cited in paragraph 207 above, EU:C:2013:160, paragraph 36, and in CB v Commission, cited in paragraph 37 above, EU:C:2014:2204, paragraph 53).

212    In addition, although the parties’ intention is not a necessary factor in determining whether an agreement between undertakings is restrictive, there is nothing prohibiting the competition authorities, the national courts or the Courts of the European Union from taking that factor into account (judgments in Allianz Hungária Biztosító and Others, cited in paragraph 207 above, EU:C:2013:160, paragraph 37, and CB v Commission, cited in paragraph 37 above, EU:C:2014:2204, paragraph 54).

 The analysis relating to the existence of a restriction of competition by object in the contested decision

213    The Commission considered, in the contested decision, that the agreements in question constituted a restriction of competition by object, for the purpose of Article 101(1) TFEU, by relying, in that respect, on a series of factors relating to the content, the context and the purpose of those agreements.

214    It thus found that the fact that Lundbeck’s original patents had expired before the conclusion of the agreements in question, but that it had obtained or applied for several process patents, including the crystallisation, amide and iodo patents, was a significant element of the economic and legal context in which those agreements had been concluded. The Commission observed, however, that a patent did not grant the right to limit the commercial autonomy of parties to an agreement by going beyond the rights granted by that patent to its holder (recital 638 of the contested decision).

215    It considered, therefore, that although all patent settlements were not necessarily problematic from a competition law perspective, such agreements were problematic where they provided for the exclusion from the market of one of the parties, which was at the very least a potential competitor of the other party, for a certain period, and where they were accompanied by a transfer of value from the patent holder to the generic undertaking liable to infringe that patent (‘reverse payment’) (recitals 639 and 640 of the contested decision).

216    It can also be seen from the contested decision that, even if the restrictions set out in the agreements in question fell within the scope of the Lundbeck patents — that is to say, that the agreements prevented only the market entry of generic citalopram produced by a process deemed by the parties to the agreements to potentially infringe those patents without covering every type of generic citalopram — they would nevertheless constitute restrictions on competition by object, since, inter alia, they prevented or rendered pointless any type of challenge to Lundbeck’s patents before the national courts, whereas, according to the Commission, that type of challenge is part of normal competition in relation to patents (recitals 603 to 605, 625, 641 and 674 of the contested decision).

217    In other words, according to the Commission, the agreements in question transformed the uncertainty in relation to the outcome of such litigation into the certainty that the generics would not enter the market, which may also constitute a restriction on competition by object when such limits do not result from an assessment, by the parties to those agreements, of the merits of the exclusive right at issue, but rather from the size of the reverse payment provided for which, in such a case, overshadows that assessment and induces the generic undertaking not to pursue its independent efforts to enter the market (recital 641 of the contested decision).

218    It must be noted, in that respect, that the Commission did not assert, in the contested decision, that all patent settlement agreements containing reverse payments were contrary to Article 101(1) TFEU; it stated only that the disproportionate nature of such payments, combined with several other factors — such as the fact that the amounts of those payments seemed to correspond at least to the profit anticipated by the generic undertakings if they had entered the market, the absence of provisions allowing the generic undertakings to launch their product on the market upon the expiry of the agreement without having to fear infringement actions brought by Lundbeck, or the presence, in those agreements, of restrictions going beyond the scope of Lundbeck’s patents — led to the conclusion that the agreements in question, in the present case, had as their object the restriction of competition, within the meaning of Article 101(1) TFEU (see recitals 661 and 662 of the contested decision).

219    As regards more specifically the classification of the agreement at issue, the main factors relied upon by the Commission are those referred to in paragraph 29 above.

220    It is necessary to examine, in the light of the principles and considerations set out above, whether, as the applicants claim, the Commission erred in concluding that the agreement at issue was a restriction by object within the meaning of Article 101(1) TFEU.

 The existence of a restriction by object in the present case

221    It must be borne in mind that it is clear from the examination of the second and third pleas in law that, first, by the agreement at issue, the applicants undertook not to enter the market during the relevant period and, secondly, the applicants were potential competitors of Lundbeck, despite the process patents that it had obtained or applied for.

222    As the Commission rightly pointed out in recitals 1300, 1331, 1332, 1338, 1361 and 1362 of the contested decision, that is, in essence, a market exclusion agreement. Such an agreement broadly equates to two examples of particularly restrictive agreements covered by the non-exhaustive list contained in Article 101(1) TFEU, namely those listed under points (b) and (c) (see paragraph 206 above), since market exclusion is an extreme form of the desire to share a market and limit production.

223    Accordingly, the Commission, which bears the burden of proof, in accordance with the case-law referred to in paragraphs 65 to 72 above, had sufficient evidence to classify the agreement at issue as a restriction by object, unless other factors relating to its objectives, viewed in their economic and legal context, gave it grounds for finding that the agreement was not sufficiently harmful to competition.

224    It is true, as the applicants claim, that, in that connection, the Commission, in the contested decision, referred to the judgment of 29 November 2012 in CB v Commission (T‑491/07, EU:T:2012:633), which had wrongly concluded that the concept of restriction by object should not be interpreted restrictively.

225    Nevertheless, the Commission also relied on earlier case-law, which the judgment in CB v Commission, cited in paragraph 37 above (EU:C:2014:2204), did not call into question.

226    It is true that, in the judgment in CB v Commission, cited in paragraph 37 above (EU:C:2014:2204), the Court of Justice rejected the General Court’s analysis in the judgment in CB v Commission, cited in paragraph 224 above (EU:T:2012:633), according to which the concept of restriction of competition by object should not be interpreted restrictively. The Court of Justice noted that the concept of restriction of competition by object could be applied only to certain types of coordination between undertakings which revealed a sufficient degree of harm to competition that it could be found that there was no need to examine their effects, otherwise the Commission would be exempted from the obligation to prove the actual effects on the market of agreements which were in no way established to be, by their very nature, harmful to the proper functioning of normal competition (see, to that effect, judgment in CB v Commission, cited in paragraph 37 above, EU:C:2014:2204, paragraph 58).

227    However, it does not follow that the Commission was required to examine the effects of the agreement at issue if it was able to establish, to the requisite legal standard, that the agreement could be considered — in view of its content, the scope of its provisions and its objectives, taken in their economic and legal context — to be sufficiently harmful to competition (paragraphs 209 to 211 above).

228    Lastly, it must be observed that the applicants wrongly submit that the concept of a restriction of competition by object gives rise to an irrebuttable presumption. It follows from the case-law that Article 101(3) TFEU, according to which certain agreements or concerted practices between undertakings may be regarded as compatible with the internal market, is also intended to apply to such restrictions (see, to that effect, judgments of 13 October 2011 in Pierre Fabre Dermo-Cosmétique, C‑439/09, ECR, EU:C:2011:649, paragraph 59, and 15 July 1994 in Matra Hachette v Commission, T‑17/93, ECR, EU:T:1994:89, paragraph 85).

229    Accordingly, it must be examined whether, as the applicants submit, the conclusions reached by the Commission as regards the context in which the agreement at issue arose call into question the classification applied to the agreement in the contested decision.

–       The classification of the agreement at issue as a settlement agreement

230    The applicants assert that the agreement at issue, which was intended to settle a genuine dispute between them and Lundbeck, must be regarded as an alternative way of exercising the fundamental right to enforce an individual’s rights by legal proceedings. The uncertainty to which the contested decision gives rise as regards the compatibility of such agreements with competition law deters the use of those forms of settlement agreements, in spite of the fact that they make commercial and economic sense, and de facto imposes an obligation on generic undertakings to challenge patents that nonetheless benefit from a presumption of validity and might be infringed by their medicinal products. In such a situation, those undertakings would have to pay huge damages and high litigation costs.

231    The Commission disputes the applicants’ arguments.

232    First, it should be observed at the outset that an agreement may be regarded as having a restrictive object even if it does not have the restriction of competition as its sole aim but also pursues other legitimate objectives (see the BIDS judgment, cited in paragraph 209 above, EU:C:2008:643, paragraph 21 and the case-law cited). Similarly, it must be recalled that, according to the case-law, an agreement is not exempt from competition law merely because it concerns a patent or is intended to settle a patent dispute (see, to that effect, judgment of 27 September 1988 in Bayer and Maschinenfabrik Hennecke, 65/86, ECR, EU:C:1988:448, paragraph 15).

233    Secondly, it must be noted that the agreement at issue did not resolve any dispute. Although, pursuant to Article 1.4 of the agreement at issue, Lundbeck and the applicants undertook not to initiate legal proceedings against each other on the basis of any patent referred to in the agreement at issue itself, that commitment was binding only during the relevant period. However, nowhere in the agreement at issue is there any provision that Lundbeck would not oppose the applicants’ market entry after the relevant period. Moreover, that is confirmed by Lundbeck’s statement cited in recital 80 of the contested decision, from which it can be seen that it did not consider that the agreements in question, including the agreement at issue, resolved any dispute.

234    Thirdly, it must be recalled that, upon examination of the third plea in law, it has been established that the agreement at issue had a much broader scope than that of any legal actions that Lundbeck could have brought against the applicants.

235    In any event, it must be noted that, even if Article 1.1 — in view inter alia of its context — had to be interpreted as meaning that, as the applicants submit, the scope of the resulting limitations on their conduct on the market coincided with the situation that would have prevailed if Lundbeck had brought legal actions against them on the basis of its patents and had succeeded in all of those actions, that does not mean that the agreement at issue could not be classified as a restriction by object.

236    Even if that were the case, the applicants were nevertheless potential competitors of Lundbeck and they accepted significant limitations on their commercial autonomy, in return for a payment from Lundbeck, determined by taking account of the expected profits if they entered the market with the generic citalopram produced using the processes available to them when that agreement was concluded, despite the uncertainty as regards the outcome of any litigation between the applicants and Lundbeck (see, inter alia, paragraphs 140 to 150, 216 and 217 above).

237    In that respect, it must be noted that nothing proves that the amount of the payments provided for in the agreement at issue was determined by taking into account the costs that would have been incurred in the event of litigation on the issue whether the applicants’ processes infringed the amide and iodo patents and whether those patents were valid. On the contrary, the profits expected by the applicants were a decisive element in that respect.

238    Although the applicants submit that the size of the amount paid by Lundbeck was established on the basis of a balancing of the risks, they nevertheless acknowledge that they have no evidence concerning that balancing of risks, allegedly because of the long duration of the procedure.

239    In any event, at the hearing, the applicants submitted that the USD 9.5 million provided for in Article 1.3 of the agreement at issue and Article 2.0 of the addendum thereto (see paragraph 15, third indent, above) had been determined on the basis of objective factors, such as the damages that the parties to that agreement could incur as a result of patent litigation. In fact, the amount of those damages necessarily depended on the size of the profits which the group could have made from its sales of generic citalopram.

240    The applicants also submitted at the hearing that the profits that they could have obtained by entering the market were greater than the USD 2 million referred to in recital 1157 of the contested decision as regards the 500 kg of API that it already had, since they could easily have produced additional API.

241    It must be noted that, although the applicants’ arguments in that respect cast doubt on the assertion that the USD 9.5 million paid by Lundbeck significantly exceeded their expected profits if they entered the market, they in no way call into question the existence of a close link between those profits and that amount, a link that the Commission referred to in recital 1158 of the contested decision. In that recital, the Commission emphasised that the amount paid by Lundbeck had probably been influenced by the fact that the applicants had a worldwide citalopram production capacity of 4.5 tonnes per year.

242    Fourthly, it must be borne in mind that the Commission did not state that the existence of a reverse payment, the amount of which appeared to correspond to the profits expected by the generic undertaking, was sufficient to establish an infringement of the Treaty rules on free competition in the present case. On the contrary, the Commission considered that settlement agreements providing for certain payments, even reverse payments, were not always problematic from a competition law perspective, provided that such payments were linked to the strength of the patent concerned, as perceived by each of the parties, and were not accompanied by restrictions intended to delay the market entry of generics (recitals 638 and 639 of the contested decision). It thus took as an example Neolab Ltd, with which Lundbeck had concluded a settlement agreement, which had not been considered to be problematic — even though it involved a reverse payment — since that payment to Neolab had been made in exchange for a commitment on Neolab’s part not to seek damages before the competent courts and Lundbeck had agreed not to bring any claims under its patents during a certain period (recitals 164 and 639 of the contested decision). In that case, the actual object of the reverse payment had been to settle a dispute between the parties, without, however, delaying the market entry of generics.

243    Although it is true that, in Neolab’s case, there had also been a first settlement agreement between the parties which provided that Neolab’s entry to the market would be delayed, pending the outcome of the litigation between Lundbeck and Lagap Pharmaceuticals Ltd, a generic undertaking, that settlement agreement was not accompanied by a transfer of value and was conditional upon Lundbeck paying damages to Neolab in the event of an unfavourable judgment in that litigation. After Lundbeck had finally decided to settle its dispute with Lagap amicably, Neolab still had an interest in obtaining damages, which required that it first have Lundbeck’s patent declared invalid. In that context, Lundbeck had deemed it preferable to settle its dispute with Neolab, by agreeing to pay it the damages incurred in respect of the year in which it had withdrawn from the market, and by committing not to make any patent claims in the event that Neolab entered the market (recital 164 of the contested decision). That latter commitment is therefore crucial, since, contrary to the agreement at issue, the reverse payment made by Lundbeck did not constitute a payment made in exchange for exclusion from the market, but was accompanied, on the contrary, by an acceptance of non-infringement and a commitment not to hinder the market entry of Neolab with its generics.

244    That was not the situation in the present case. Accordingly, the Commission could impose fines in respect of the agreement at issue, without thereby ruling out any possibility of patent disputes being settled amicably in a manner compatible with competition law.

245    In those circumstances, the applicants’ arguments must be rejected.

–       The allegedly pro-competitive character of the agreement at issue

246    The applicants submit that the agreement at issue had a pro-competitive character, since it provided that they would distribute Lundbeck’s Cipramil (see paragraph 15, fourth indent, above), as a finished product, which allowed the applicants to develop relationships with wholesalers and allowed Lundbeck to increase the sales of its product.

247    In that respect, it must be borne in mind that the applicants became distributors of Cipramil and enjoyed a discount of 40% on the purchase of Cipramil under Article 1.3 of the agreement at issue, that is to say the same provision which provided for the payments which constituted the consideration for the obligations described in paragraph 1.1.

248    Accordingly, as the Commission rightly submits, it is not a separate distribution agreement, with a pro-competitive character. The provisions concerning distribution were an integral part of the agreement at issue and served to supplement the consideration granted to the applicants for refraining from the production and sale of their own citalopram during the relevant period, as Lundbeck admitted, according to the documents cited in recitals 576 and 1152 of the contested decision.

249    Moreover, it is immaterial whether discounts are common in the pharmaceutical sector, given that the discount at issue was not granted under normal conditions of competition. In addition, the applicants do not explain the reason, other than as consideration for the obligations set out in Article 1.1, that Lundbeck granted them 10% of its Cipramil sales in the United Kingdom, at a price 40% less than Lundbeck’s ex-factory price, which constituted a loss of GBP 3 million for Lundbeck.

250    In those circumstances, it cannot be considered that the agreement at issue had a pro-competitive character.

251    It follows that the applicants’ arguments are not well founded.

–       The analogies with the case that gave rise to the BIDS judgment

252    The applicants deny that the circumstances of the present case can be treated — as the Commission treated them in the contested decision — as being analogous to the circumstances of the case that gave rise to the BIDS judgment, paragraph 209 above (EU:C:2008:643) (‘the BIDS case’). In that case, there was no uncertainty as to the fact that the parties to the agreement concerned were competitors or that the objective nature of the agreement was restriction of competition. However, in the present case, the parties to the agreement at issue were not potential competitors, due to Lundbeck’s patents, which enjoyed a presumption of validity, and the fact that the applicants did not have an MA. That absence of potential competition is confirmed by the fact that the applicants did not begin to sell their citalopram until five months after the expiry of the relevant period.

253    The Commission disputes the applicants’ arguments.

254    It must be recalled that, in recitals 657 and 658 of the contested decision, the Commission found that there were parallels between the agreements to which the BIDS case related and the agreements in question, including the agreement at issue.

255    That finding of the Commission must be upheld.

256    As can be seen from, inter alia, paragraph 8 of the BIDS judgment, cited in paragraph 209 above (EU:C:2008:643), the undertakings active on the beef processing market in Ireland had created a mechanism by which some undertakings agreed to stay out of that market for two years in exchange for payments from the undertakings that stayed in the market. A similar dynamic arose in the present case through the conclusion of the agreement at issue, pursuant to which the principal, or even the only, undertaking present on the market with citalopram in the countries concerned by that agreement paid the applicants, which were potential competitors, so that they would stay out of the market for a given period.

257    It follows that both the BIDS case and the present case concern agreements that limited the ability of competing economic operators to determine independently the policy that they intended to adopt on the market, by preventing the normal operation of the competitive process (see, to that effect, the BIDS judgment, cited in paragraph 209 above, EU:C:2008:643, paragraphs 33 to 35).

258    It is true that, unlike the situation in the BIDS case, the agreement at issue was concluded in a context in which Lundbeck held patents allowing it to prevent the market entry of products which infringed them. It must be recalled, nevertheless, that, in the present case, the existence of Lundbeck’s patents, in particular the amide and iodo patents, did not preclude the applicants from being considered potential competitors of Lundbeck, as can be seen from the assessment of the second plea in law. Likewise, it is true that, in the BIDS case, the undertakings in question were actual competitors, since that case concerned the removal from the market of undertakings which were already present on that market, whereas, in the present case, Lundbeck and the applicants were potential competitors. However, Article 101 TFEU protects potential competition as well as actual competition.

259    Furthermore, it must be recalled that, in paragraphs 84 and 85 of the judgment in CB v Commission, cited in paragraph 37 above (EU:C:2014:2204), the Court of Justice essentially highlighted the fact that the agreements referred to in the BIDS case changed the structure of the market and revealed such a degree of harm that they could be classified as a restriction by object, whereas that was not the case of the conduct at issue in the case that gave rise to the judgment in CB v Commission, cited in paragraph 37 above (EU:C:2014:2204), which consisted in the obligation imposed on banks to pay a fee or limit their bank card issuing activities.

260    In that regard, even if paragraphs 84 and 85 of the judgment in CB v Commission, cited in paragraph 37 above (EU:C:2014:2204), may be read as meaning that the alteration of the structure of the market is a condition sine qua non for finding a restriction by object, the agreement at issue affected the structure of the market concerned, since it was intended to delay the applicants’ market entry, thus allowing Lundbeck to retain high prices for Cipramil and to ensure favourable conditions for the launch of Cipralex, which was supposed to replace Cipramil in the treatment of numerous patients (see paragraphs 11, 91 and 181 above).

261    Consequently, the Commission was entitled, in the contested decision, to apply by analogy the BIDS judgment, cited in paragraph 209 above (EU:C:2008:643), and therefore the applicants’ present argument must be rejected.

262    Furthermore, the applicants’ other arguments concerning the lack of an MA and the date of their market entry after the relevant period have already been rejected in the context of the second plea in law (see paragraphs 112 to 137 above).

–       The intentions of the parties to the agreement at issue

263    The applicants claim that, in order to classify the agreement at issue as a restriction by object, the Commission ascribed excessive significance to the subjective intention of the parties at the time when they concluded that agreement, whereas the question whether an agreement entails such a restriction should be assessed objectively. According to the applicants, while it is true that the parties’ subjective intention may confirm the existence of a restriction by object, it cannot be the determining factor for that purpose. In the present case, the Commission considered that the limitations on the applicants’ conduct arising from the agreement at issue were restrictions by object on the ground that they were not the result of assessments of the strength of the patents in question undertaken independently by the parties, but rather constituted the consideration for the payments which Lundbeck had undertaken to make, sharing with the applicants the profits which it received by virtue of its monopoly in the sales of citalopram. Such a subjective test gives rise to significant uncertainty and cannot therefore be used in order to establish whether a settlement agreement in the pharmaceutical sector constitutes a restriction by object.

264    The Commission disputes the applicants’ arguments.

265    In that respect, first, it must be recalled that the case-law on the concept of restriction by object allows the intentions of the parties to an agreement to be taken into account (see paragraph 212 above), provided that the Commission’s conclusion is also based on objective elements.

266    Secondly, it must be pointed out that, in the contested decision, the agreement at issue was found to contain a restriction of competition by object because of its objectives, its content and the context in which it had been concluded. In that respect, as can be seen from the examination of the second and third pleas in law, the Commission relied inter alia on objective evidence, relating to the statements and conduct of the parties to that agreement, dating, in particular, from before that agreement was signed and therefore in tempore non suspecto.

267    The applicants’ arguments must therefore be rejected.

–       The lack of precedents and the absence of legal certainty

268    The applicants emphasise that it took the Commission 10 years to decide that the agreements in question, including the agreement at issue, constituted restrictions by object, which is incompatible with the obvious nature that such restrictions must have. Besides, the Commission itself considered that such agreements, which for a long time have been in common usage in the EEA without intervention by the Commission, were in a ‘grey zone’, as stated in a KFST press release of 28 January 2004 (‘the KFST press release’). The scope of the concept of restriction by object was therefore vague at the time of conclusion of the agreement at issue and the applicants were therefore unable to realise that it entailed such a restriction.

269    The Commission disputes the applicants’ arguments.

270    In that respect, it must be noted that, well before the date on which the agreement at issue was concluded, the Court had ruled on the application of competition law in fields characterised by the presence of intellectual property rights, as can be seen inter alia from the considerations set out in paragraphs 140, 141 and 232 above).

271    Moreover, it must be noted that Lundbeck was aware that its conduct was at least capable of posing problems from the point of view of competition law. It admitted this in the minutes of the meeting of 17 April 2002 (see paragraph 86 above) and in the letter cited in recital 188 of the contested decision. That perception was shared, for example, by the generic undertaking mentioned in recital 190 of the contested decision. Accordingly, it is not credible that the applicants did not understand that their conduct was problematic from a competition law perspective.

272    Moreover, it is not necessary that the same type of agreement should have already been censured by the Commission in order for them to be considered a restriction of competition by object. The role of experience, mentioned by the Court of Justice in paragraph 51 of the judgment in CB v Commission (cited in paragraph 37 above, EU:C:2014:2204), does not concern the specific category of an agreement in a particular sector, but rather refers to the fact that it is established that certain forms of collusion are, in general and in view of the experience gained, so likely to have negative effects on competition that it is not necessary to demonstrate that they had such effects in the particular case at hand. 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 therefore 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 having regard to their content, purpose and context (see, to that effect, judgment in CB v Commission, cited in paragraph 37 above, EU:C:2014:2204, paragraph 51; the Opinion of Advocate General Wahl in CB v Commission, C‑67/13 P, ECR, EU:C:2014:1958, point 142, and the Opinion of Advocate General Wathelet in Toshiba Corporation v Commission, C‑373/14 P, ECR, EU:C:2015:427, point 74).

273    As regards more specifically the KFST press release, on which the applicants rely, whilst it is true that it refers to the Commission’s opinion regarding the anticompetitive nature of the agreements in question, including the agreement at issue, it must be noted that it was not issued directly by the Commission or its departments, but is a press release from a national competition authority.

274    In that regard, it follows from the case-law that national competition authorities cannot cause undertakings to entertain a legitimate expectation that their conduct does not infringe Article 101 TFEU, since they do not have the power to adopt a negative decision, that is to say, a decision concluding that there is no infringement of that provision (see, to that effect, judgment of 18 June 2013 in Schenker & Co. and Others, C‑681/11, ECR, EU:C:2013:404, paragraph 42 and the case-law cited).

275    Furthermore, the KFST press release clearly states that, following a preliminary assessment, there were doubts as to whether or not those agreements were anticompetitive, in view in particular of the size of the payment made by Lundbeck to the generic undertakings, and that the Commission was therefore going to launch a broader investigation into that type of agreement in the pharmaceutical field.

276    It was specifically following that investigation, which enabled the Commission to form a clearer idea of the operation of settlements in the pharmaceutical sector, that the Commission opened proceedings on the basis of Article 101(1) TFEU against Lundbeck and generic undertakings such as the applicants.

277    Finally and in any event, it is also clear from the KFST press release that any agreement whose object is to acquire the market exclusion of a competitor is anticompetitive.

278    The applicants cannot therefore claim that the Commission changed its view and that that prevents it from applying the concept of restriction by object, given that it was specifically following a detailed investigation of the pharmaceutical sector that the Commission was able to refine its approach and fully comprehend the anticompetitive nature of certain agreements, in particular where those agreements involve a significant reverse payment.

279    It follows that, at the time of conclusion of the agreement at issue, it was already established that a patent holder was not entitled to pay a potential competitor to give up some or indeed all real concrete possibilities of entering the market in exchange for a sum paid by that holder and determined on the basis of the profits expected by that competitor in the event of market entry. A fortiori, at the time when the contested decision was issued, the Commission was entitled to take the view that experience showed that agreements such as those in question could be restrictions by object, provided that its examination of the legal and economic context in which they had been concluded did not preclude such a finding.

280    The applicants’ present arguments must therefore be rejected.

–       Infringement of the principle of protection of legitimate expectations

281    The applicants allege, in essence, a breach of the principle of protection of legitimate expectations, in that the Commission did not respect the Guidelines on the applicability of Article 101 [TFEU] to horizontal cooperation agreements (OJ 2001 C 3, p. 2). According to the applicants, those guidelines contain an exhaustive list of the forms of collusion that could constitute restrictions by object, which in no way refers to agreements such as those referred to in the contested decision.

282    The Commission disputes the applicants’ arguments.

283    It suffices to note, as the Commission submits, that those guidelines were not intended to provide a binding and exhaustive definition of restrictions by object, but merely presented examples of that type of restriction, in particular in points 18, 25 and 188. Moreover, points 18 and 25 refer to agreements intended to share customers and limit production, to which the agreement at issue is very similar. The exclusion of a potential competitor from the market is an extreme form of the desire to share customers and limit production.

284    Accordingly, the Commission did not infringe the principle of protection of legitimate expectations, with the result that the applicants’ arguments cannot succeed.

–       Lundbeck’s refusal to purchase the applicants’ API

285    The applicants maintain that, in the light of the situation in which they found themselves, and especially the fact that Lundbeck had led them to believe that it was interested in their API — which it was not —, the only remaining solution that made commercial sense was to conclude the agreement at issue.

286    The Commission disputes the applicants’ arguments.

287    It must be observed that, in view of the circumstances of the present case highlighted in the examination of the second and third pleas in law, it cannot be found that, after Lundbeck revealed that it was not interested in purchasing the applicants’ API (see paragraph 90 above), the only option open to the applicants was to reach an agreement that would prevent them from entering the market with their citalopram during a certain period, without any guarantee that they would not be sued for infringement subsequently, in exchange for reverse payments, the amount of which exceeded or at the very least corresponded to the profits they expected to make if they entered the market.

288    First, as potential competitors of Lundbeck, the applicants had a real concrete possibility of entering the market. They could therefore have continued their efforts to sell their generic medicinal product themselves or have become the API suppliers of other generic undertakings. Secondly, they could have concluded an agreement with Lundbeck that did not restrict competition.

289    Moreover, while it is true that the agreement at issue was an advantageous solution for both the applicants and Lundbeck, it must be borne in mind that the fact that the adoption of anticompetitive conduct may prove to be the most cost-effective or least risky course of action for an undertaking in no way excludes the application of Article 101 TFEU (see, to that effect, judgments of 8 July 2004 in Corus UK v Commission, T‑48/00, ECR, EU:T:2004:219, paragraph 73, and Dalmine v Commission, T‑50/00, ECR, EU:T:2004:220, paragraph 211).

290    Accordingly, those arguments cannot be accepted.

–       The United States case-law

291    The applicants refer to the judgment of the Supreme Court of the United States of 17 June 2013 in Federal Trade Commission v Actavis (570 U.S. (2013), ‘the Actavis judgment’) in which the Supreme Court declined to find that an agreement similar to the agreement at issue could be characterised as a ‘per se’ violation within the meaning of United States (US) antitrust law, which corresponds to the concept of restriction by object in EU law, and held that the evaluation of that agreement had to apply the ‘rule of reason’, which corresponds to an analysis of its anticompetitive effects.

292    The Commission disputes the applicants’ arguments.

293    These arguments must be rejected.

294    Even if the applicants’ reading of the Actavis judgment, cited in paragraph 291 above, is justified and the approach taken by the Commission in the contested decision is not consistent with that adopted by the US authorities, it has already been held that a position adopted by US law cannot take precedence over that adopted by EU law and that an infringement of US law does not constitute as such a defect resulting in the illegality of a decision adopted under EU law (see, to that effect, judgment of 30 September 2003 in Atlantic Container Line and Others v Commission, T‑191/98 and T‑212/98 to T‑214/98, ECR, EU:T:2003:245, paragraph 1407).

295    In any event, the judgment containing the majority opinion of the Supreme Court of the United States in the Actavis case (the Actavis judgment, cited in paragraph 291 above) — and not the dissenting opinion of Judge Roberts — clearly establishes that the fact that an agreement falls within the scope of a patent does not exempt it from an antitrust action. As the concept of restriction by object does not exist in US law and is not equivalent to the ‘per se’ rule because of the possibility of justifying such a restriction under Article 101(3) TFEU, it is not correct to equate the ‘rule of reason’ under US law to the ‘effects’ test pursuant to Article 101(1) TFEU, as the applicants propose. Moreover, contrary to the applicants’ contention, the contested decision does not rely on presumptions, but on an analysis of the agreements, their content and their context, before concluding that they restrict competition by their very object.

296    In the light of all the foregoing considerations, it is necessary to reject both the first plea in law and the arguments set out in the third plea in law which were examined in the context of that plea, relating to the role of the payments provided for in the agreement at issue and the alleged pro-competitive effects of that agreement. Moreover, the argument put forward by the applicants in that context, relating to an alleged ‘bluff’ on their part as regards Lundbeck, must be rejected in view of the considerations set out in paragraphs 63, 64 and 84 to 111 above.

 The fourth plea in law, alleging that the fine is unjustified and disproportionate

297    By their fourth plea in law, which they raise in the alternative, the applicants ask the Court to find that the fine imposed on them is unjustified and disproportionate and should therefore be reduced to zero or, in the further alternative, to an amount less than that set by the Commission in the contested decision.

298    The present plea consists, in essence, of three parts, alleging, first, that the contested decision is novel and that there has been a breach of the principle of legal certainty, the principle that penalties must have a proper legal basis, the principle of non-retroactivity and the principle of protection of legitimate expectations; secondly, that there has been a breach of the 2006 Guidelines; and, thirdly, that the duration of the investigation was unreasonable.

299    Before examining those parts, it must be recalled that the review of legality of decisions adopted by the Commission is supplemented by the unlimited jurisdiction which the EU judicature is afforded by Article 31 of Regulation No 1/2003, in accordance with Article 261 TFEU. That jurisdiction empowers the Court, in addition to carrying out a mere review of the lawfulness of the penalty, to substitute its own appraisal for the Commission’s and, consequently, to cancel, reduce or increase the fine or penalty payment imposed (judgment of 27 February 2014 in InnoLux v Commission, T‑91/11, ECR, EU:T:2014:92, paragraph 156).

300    It is therefore for the Court, in the exercise of its unlimited jurisdiction, to assess, on the date on which it adopts its decision, whether the fine imposed on the applicant was one whose amount properly reflects the gravity and duration of the infringement in question (judgments in InnoLux v Commission, cited in paragraph 299 above, EU:T:2014:92, paragraph 157, and of 10 December 2014 in ONP and Others v Commission, T‑90/11, ECR, EU:T:2014:1049, paragraph 352).

301    It must be pointed out, however, that the exercise of unlimited jurisdiction is not a review that is conducted by the Court of its own motion (judgment of 8 December 2011 in KME Germany and Others v Commission, C‑389/10 P, ECR, EU:C:2011:816, paragraph 131).

 The first part, alleging that the contested decision is novel and that there has been a breach of the principle of legal certainty, the principle that penalties must have a proper legal basis, the principle of non-retroactivity and the principle of protection of legitimate expectations

302    By the first part of the present plea in law, the applicants claim that the Commission ought not to have imposed a fine on them or, at most, ought merely to have imposed a symbolic fine, since at the time of the conclusion of the agreement at issue there was significant legal ambiguity about settlement agreements providing for reverse payments. The applicants maintain that an allegedly extensive and novel interpretation of Article 101(1) TFEU in the contested decision breaches the principle of legal certainty, the principle that penalties must have a proper legal basis (nulla poena sine lege), the principle of non-retroactivity and the principle of protection of legitimate expectations.

303    The Commission disputes the applicants’ arguments.

304    It should be recalled that, according to the case-law, the principle that penalties must have a proper legal basis and the principle of legal certainty cannot be interpreted as prohibiting the gradual clarification of the rules of liability but may preclude the retroactive application of a new interpretation of a rule establishing an offence. That is particularly true of a judicial interpretation which produces a result that was not reasonably foreseeable at the time when 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 in Telefónica and Telefónica de España v Commission, cited in paragraph 73 above, EU:C:2014:2062, paragraphs 147 and 148 and the case-law cited).

305    In that regard, it follows from the case-law that the scope of what is foreseeable depends to a considerable degree on the content of the text at issue, the field which it covers and the number and status of those to whom it is addressed, and that 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 (judgment of 28 June 2005 in 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, ECR, EU:C:2005:408, paragraph 219).

306    Moreover, with regard to whether an offence was committed intentionally or negligently and is therefore liable to be penalised by the imposition of a fine in accordance with the first subparagraph of Article 23(2) of Regulation No 1/2003, it is settled case-law that that condition is satisfied where the undertaking concerned cannot be unaware of the anticompetitive nature of its conduct, whether or not it is aware that it is infringing the competition rules of the Treaty (see judgment in Schenker & Co. and Others, cited in paragraph 274 above, EU:C:2013:404, paragraph 37 and the case-law cited).

307    In the present case, it follows from the examination of the third plea in law (see in particular paragraphs 268 to 280 above) that there was no legal uncertainty regarding the possibility of classifying as a restriction by object an agreement which had the characteristics of the agreement at issue and which came about in the context of that agreement.

308    Since the applicants could not have been unaware that the conclusion of the agreement at issue was problematic from the perspective of competition law, the present argument must be rejected.

309    That conclusion cannot be called into question by the applicants’ line of argument based on certain precedents in which undertakings that had committed an infringement of competition law were granted a reduction of the amount of the fine because they could not have known with certainty that their conduct was anticompetitive.

310    First, as regards the case that gave rise to the judgment of 3 July 1991 in AKZO v Commission (C‑62/86, ECR, EU:C:1991:286), it must be observed that the Court of Justice, in order to grant a reduction of 25%, took account of not only the novelty of the infringement in question, but also other factors, in particular the fact that it did not significantly affect the market shares of the undertakings concerned (paragraph 163 of that judgment). Those considerations are not applicable in the present case. In addition, the infringement in question in that case related to an abuse of a dominant position as a result of the application of ‘predatory prices’, that is to say conduct the unlawful nature of which is not as obvious as conduct consisting in excluding a competitor from the market in return for payment.

311    Secondly, as regards the case that gave rise to the judgment in AstraZeneca v Commission, cited in paragraph 79 above (EU:C:2012:770), it suffices to note that, according to the Court of Justice, even though the Commission and the Courts of the European Union had not yet had the opportunity to rule specifically on conduct such as that which characterised the abuses of a dominant position in question in that case, the undertaking concerned was aware of the highly anticompetitive nature of its conduct and should have expected it to be incompatible with the competition rules under European Union law (see, to that effect, judgment in AstraZeneca v Commission, cited in paragraph 79 above, EU:C:2012:770, paragraph 164). Accordingly, no reduction of the fine had to be granted. The same reasoning applies in the present case, since neither Lundbeck nor the applicants were unaware (or could reasonably have been unaware) of the anticompetitive nature of their conduct (see paragraph 271 above).

312    Thirdly, as regards the case that gave rise to the judgment of 9 September 2009 in Clearstream v Commission (T‑301/04, ECR, EU:T:2009:317), it must be noted that that judgment does not deal with the question of the non-imposition of the fine at issue in Commission Decision C(2004) 1958 final of 2 June 2004 relating to a proceeding under Article [102 TFEU] (Case COMP/38.096 — Clearstream (Clearing and Settlement)). Accordingly, the applicants cannot rely on that judgment; they may only rely on that decision. In that regard, it must be borne in mind that, according to settled case-law, the Commission’s previous decision-making practice does not in itself serve as a legal framework for the fines imposed in competition matters, since that framework is defined solely in Regulation No 1/2003 and in the applicable guidelines. Consequently, decisions in other cases can give only an indication for the purpose of determining whether there might be discrimination, since the facts of those cases, such as the markets, the products, the undertakings and the periods concerned, are not likely to be the same (see, to that effect, judgments in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 58 above, EU:T:2012:332, paragraphs 260 to 262, and of 27 February 2014 in LG Display and LG Display Taiwan v Commission, T‑128/11, EU:T:2014:88, paragraph 143). In the present case, the facts of the case that gave rise to the abovementioned decision, such as the markets, the products, the countries, the undertakings and the periods in question, are not comparable to those of the present case, with the result that that decision is not relevant in assessing whether the fine is justified and proportionate.

313    In view of the foregoing considerations, the present part must be rejected.

 The second part, alleging a breach of the 2006 Guidelines

314    In the context of the second part of the present plea in law, the applicants submit that the Commission did not comply with the 2006 Guidelines when it determined the amount of the fine imposed on them.

315    In the first place, the applicants submit that the Commission did not sufficiently explain its reasons for departing from the general methodology laid down in the 2006 Guidelines, based on the value of sales of the relevant product. In addition, the applicants maintain that the Commission ought not to have relied on considerations associated with an objective of general deterrence, in view of the fact that, until the adoption of the contested decision, settlement agreements involving reverse payments had not been considered to be anticompetitive.

316    The Commission disputes the applicants’ arguments.

317    In that respect, it should be recalled that, as was observed in paragraph 30 above, the Commission used two different methods to calculate, first, the amount of the fine to be imposed on Lundbeck and, secondly, the amount of the fines to be imposed on the generic undertakings, including the applicants.

318    As regards Lundbeck, the Commission used the general method provided for in the 2006 Guidelines and thus calculated the basic amount on the basis of a proportion of the value of the sales of goods or services, made by Lundbeck, related directly or indirectly to the infringements, in the relevant geographic area within the EEA (points 13 and 19 of those guidelines). The figure adopted was 10 or 11%, depending on the geographic scope of the agreements in question.

319    As regards the applicants, like, moreover, the other generic undertakings concerned, the Commission noted that, as a result of the agreement at issue, they had sold virtually no citalopram during the relevant period and it therefore considered that it was necessary to apply point 37 of the 2006 Guidelines, which states that the particularities of a given case or the need to achieve deterrence in a particular case may justify departing from the general methodology.

320    The method applied to the applicants therefore consisted in using as the basic amount the value of the payments which it had received from Lundbeck, that is to say, EUR 11.5 million (see paragraph 32 above).

321    In view of the applicants’ lack of sales on the market, it cannot seriously be disputed that the Commission was obliged to depart from the general methodology.

322    Similarly, it must be observed that the method used by the Commission in the present case as regards the applicants enabled the Commission to deprive the applicants of the profits they had obtained by concluding the agreement at issue.

323    Furthermore, even if, by the application of that method, the Commission had fixed the amount of the fine imposed on the applicants at an amount which exceeded those profits, 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 to deter that undertaking and other undertakings from engaging in such conduct. Thus, even if that were the case, the amount of the fine imposed by the Commission would nevertheless not be disproportionate.

324    Lastly, it follows from the considerations set out in paragraphs 268 to 280 and 304 to 307 above that there was no legal uncertainty regarding the possibility of an agreement such as the agreement at issue being characterised as an infringement by object. Accordingly, the applicants’ complaint that the Commission did not have to pursue, in the present case, an objective of general deterrence is based on an erroneous premiss.

325    Consequently, the applicants’ arguments cannot be accepted.

326    In the second place, the applicants take issue with the merits of the Commission’s decision to calculate the basic amount of that fine according to a method based on the size of the amounts that Lundbeck paid them. First of all, the Commission included in its calculation a sum of GBP 3 million to reflect the discount which they received when purchasing the Cipramil produced by Lundbeck which they distributed. Such a discount on the ex-factory price is common practice in business relationships, as may be seen from other distribution agreements concluded by the applicants, and therefore does not form part of the profit which they made under the agreement at issue, when their distribution costs are also taken into account.

327    The Commission disputes the applicants’ arguments.

328    In that regard, it is appropriate to refer to the reasoning set out in paragraphs 246 to 251 above. In addition, it must be noted that the fact that the applicants may also have enjoyed discounts in the context of the distribution of other medicinal products cannot alter the fact that the discount in question formed part of the consideration obtained by the applicants in exchange for the obligations imposed by Article 1.1.

329    Moreover, as can be seen from recital 1373 and footnote No 2264 of the contested decision, and from the Commission’s written reply to a question put to it by the Court, account was taken of the distribution costs incurred by the applicants in calculating the amount of the fine. The Commission applied a discount of 10% of the applicants’ turnover derived from the distribution of Cipramil, which was GBP 8.5 million. Since the applicants could not produce evidence concerning the extent of their distribution costs and, in the reply to the statement of objections, they merely stated that those costs amounted to a proportion between 15 and 25% of the value of their Cipramil sales, the Commission chose a percentage between those proposed by the applicants and a percentage — 1% — corresponding to Lundbeck’s distribution costs, according to the information that Lundbeck provided in that respect during the administrative procedure concerning its own sales. Since the relevant turnover amounted to GBP 8.5 million (recital 585 of the contested decision), the equivalent of EUR 12.3 million, the Commission subtracted EUR 1.23 million from the total amount that Lundbeck had transferred to the applicants under the agreement at issue, namely EUR 12.7 million. The basic amount of the fine imposed on the applicants was set, after rounding down, at EUR 11.5 million.

330    It must be noted that the applicants do not call into question those calculations, but merely submit that they do not have more specific information on their distribution costs, as a result of the duration of the procedure.

331    In view of the foregoing considerations, the applicants’ arguments must be rejected.

332    In the third place, the applicants take issue with the Commission for not having taken into account the fact that their role in the alleged infringement was passive and subordinate and that Lundbeck had misled them, depriving them of other viable options.

333    The Commission disputes the applicants’ arguments.

334    It must be emphasised that, even leaving aside the fact that passive participation in an infringement is not a mitigating circumstance within the meaning of the 2006 Guidelines, as the Commission rightly submits, it is the applicants which requested Lundbeck to conclude an agreement, as can be seen inter alia from recital 558 of the contested decision. In any event, it must be noted that both the applicants and Lundbeck had an interest in concluding the agreement at issue, which allowed them to share the rent from Lundbeck’s monopoly on citalopram sales and to avoid the risks inherent in the applicants’ market entry.

335    Lastly, the fact that Lundbeck may have misled the applicants cannot justify their decision to participate in an anticompetitive agreement or constitute a mitigating circumstance.

336    It follows that the applicants’ arguments are not well founded.

337    In the fourth place, according to the applicants, the Commission ignored the fact that the agreement at issue concerned only the amide and iodo patents, which were of marginal importance by comparison with the crystallisation patent.

338    The Commission disputes the applicants’ arguments.

339    In that respect, it suffices to note that, as the Commission submits, the contested decision, in particular in recitals 563, 564, 1109, 1111, 1113 to 1115, 1135 and 1136 as well as footnotes Nos 295 and 1027, provides all the explanations necessary to understand that the possible breach of the amide and iodo patents by the processes available to the applicants when the agreement at issue was concluded was at the origin of the negotiations that led to the signing of that agreement, even though the scope of the restrictions set out in that agreement went beyond the restrictions that could be derived from those patents. The fact that the contested decision refers more often to the crystallisation patent does not call into question that finding and can be explained by the fact that the other agreements in question were linked to that patent, which was also invoked in the context of legal proceedings within the EEA. 

340    The present argument must therefore be dismissed.

341    In the fifth place, in the applicants’ submission, the Commission was mistaken when it considered that the agreement at issue had been implemented, in spite of what they claim to have been their competitive conduct on the market during the relevant period. Likewise, the Commission failed to draw the inferences from the lack of effects of the agreement, at least as regards the possibility for the applicants to sell citalopram in the form of API.

342    The Commission disputes the applicants’ arguments.

343    In that respect, it must be observed that the Commission did not rely on the implementation of the agreement in order to set the amount of the fine to be imposed on the applicants, amongst others, as can be seen from recital 1361 of the contested decision, but rather followed a different method, in view of the circumstances of the case. As noted in paragraphs 316 to 324 above, that method was appropriate.

344    Consequently, the first argument is unfounded.

345    In the sixth place, the applicants maintain that the Commission imposed on them a fine that was disproportionate in view of the duration of the relevant period and that, in any event, the duration of the infringement should be reduced to reflect the minimum period necessary for the applicants to obtain an MA.

346    The Commission disputes the applicants’ arguments.

347    In that respect, it must be noted, as the Commission submits, that the amounts that Lundbeck paid to the applicants reflected the value of the restrictions they had accepted during the relevant period. In addition, since those restrictions concerned potential competition and the latter could exist irrespective of whether an MA was obtained, there is no reason to reduce the fine in order to take account of the fact that the applicants could not enter the market from the beginning of the relevant period.

348    Accordingly, those arguments cannot be accepted.

349    In the seventh place, the applicants submit that the Commission did not take account of the fact that the public authorities in the United Kingdom encourage settlement agreements.

350    The Commission disputes those arguments.

351    In that respect, it suffices to note that, as the Commission rightly submits, the United Kingdom authorities have never encouraged the conclusion of settlement agreements contrary to Article 101 TFEU and that, in any event, the agreement at issue did not resolve any dispute, since Lundbeck in no way undertook not to sue the applicants if they entered the market with their citalopram after the relevant period.

352    That argument must therefore be rejected, as must the present part of the fourth plea in law in its entirety.

 The third part, alleging that the duration of the investigation was unreasonable

353    By the third part of the present plea in law, the applicants maintain that the duration of the Commission’s investigation culminating in the adoption of the contested decision ought to have led to a larger reduction of the fine than the 10% granted by the Commission.

354    In that regard, they claim that if the Commission had warned them before 2010 (see paragraph 22 above), as it did with Lundbeck, that it was in the process of investigating the agreement at issue, they would have been able to retain evidence useful to their defence, which they no longer had when they learnt that the Commission had initiated an investigation affecting them. In particular, the applicants observe that the vast majority of their employees who had been involved in the procedure culminating in the conclusion of the agreement at issue had already left the undertaking in 2010. As for the employees still present, they were no longer in a position to recall in detail the events which occurred at the relevant time.

355    Furthermore, the applicants maintain that they cannot be criticised for any lack of diligence on the ground that they did not retain the evidence that would have been useful to their defence for longer than the six-year period prescribed by what they claim are the relevant United Kingdom provisions. In that regard, they submit that the Commission, which denies the relevance of the KFST press release in respect of the lack of legal clarity invoked by the applicants, cannot rely on that document to support its assertion that they could suspect that the competition authorities would examine the agreement at issue.

356    The Commission disputes the applicants’ arguments.

357    First, it must be recalled that compliance with the requirement that administrative procedures relating to competition policy be conducted within a reasonable time constitutes a general principle of EU law whose observance the Courts of the European Union ensure (see judgment of 19 December 2012 in Bavaria v Commission, C‑445/11 P, EU:C:2012:828, paragraph 77 and the case-law cited).

358    It is also settled case-law that the question whether the duration of the administrative procedure is reasonable must be determined in the light of the particular circumstances of each case and, in particular, the background to the case, the various procedural stages followed, the complexity of the case and its importance for the various parties involved (judgments of 15 October 2002 in Limburgse Vinyl Maatschappij and Others v Commission, C‑238/99 P, C‑244/99 P, C‑245/99 P, C‑247/99 P, C‑250/99 P to C‑252/99 P and C‑254/99 P, ECR, EU:C:2002:582, paragraph 187, and 30 September 2003 in Aristoteleio Panepistimio Thessalonikis v Commission, T‑196/01, ECR, EU:T:2003:249, paragraph 230).

359    Furthermore, it must be borne in mind that the fact that a reasonable time is exceeded, on the assumption that it is established, does not necessarily constitute a ground for annulment of the decision that is challenged. For the purposes of the application of the competition rules, the fact of exceeding a reasonable time can constitute a ground for annulment, in the case of a decision finding infringements, only where it has been established that the breach of that principle adversely affected the rights of defence of the undertakings concerned. Other than in that specific case, failure to observe the duty to deal with the matter within a reasonable time has no effect on the validity of the administrative procedure under Regulation No 1/2003 (see judgment of 18 June 2008 in Hoechst v Commission, T‑410/03, ECR, EU:T:2008:211, paragraph 227 and the case-law cited).

360    It must also be noted that, according to the case-law, for the purposes of the application of the ‘reasonable time’ principle, a distinction must be drawn between the two phases of the administrative procedure, namely the investigation phase preceding the statement of objections (‘the first phase’) and the phase corresponding to the remainder of the administrative procedure (‘the second phase’), each of which has its own internal logic. The first phase, covering the period up to notification of the statement of objections, begins on the date on which the Commission takes measures which imply an accusation of an infringement and must enable the Commission to adopt a position on the course which the procedure is to follow. The second phase covers the period from notification of the statement of objections to adoption of the final decision. It must enable the Commission to reach a final decision on the alleged infringement (judgment of 21 September 2006 in Technische Unie v Commission, C‑113/04 P, ECR, EU:C:2006:593, paragraphs 42 and 43).

361    In that regard, it has been held that the excessive duration of the first phase may have an effect on the future ability of the undertakings concerned to defend themselves, in particular by reducing the effectiveness of the rights of the defence where they are relied on in the second phase, owing to the passage of time and the resulting difficulty in obtaining exculpatory evidence. It is necessary, however, in such a case, for the undertakings concerned to demonstrate in a sufficiently precise manner that they experienced difficulties in defending themselves against the Commission’s claims, specifying the documents or testimonies that they could no longer obtain and the reasons why that was capable of compromising their defence (see, to that effect, judgments in Technische Unie v Commission, cited in paragraph 360 above, EU:C:2006:593, paragraphs 54 and 60 to 71, and of 29 March 2011 in ArcelorMittal Luxembourg v Commission and Commission v ArcelorMittal Luxembourg and Others, C‑201/09 P and C‑216/09 P, ECR, EU:C:2011:190, paragraph 118).

362    Similarly, according to the case-law, those undertakings must indicate in detail, if not the specific items of evidence that have disappeared, at least the incidents, events or circumstances which prevented them, during the period in question, from complying with their obligation of diligence and brought about the alleged disappearance of the evidence alluded to. Only by examining such specific indications can the European Union judicature assess whether an undertaking has shown to the requisite legal standard that it experienced the alleged difficulties in defending itself against the Commission’s claims as a result of the excessive length of the administrative procedure, or whether, instead, those difficulties in fact derive from a failure to comply with its obligation of diligence (judgment in ArcelorMittal Luxembourg v Commission and Commission v ArcelorMittal Luxembourg and Others, cited in paragraph 361 above, EU:C:2011:190, paragraphs 120 to 122).

363    In order to apply those principles in the present case, it is necessary to begin by recalling below the sequence of the principal events leading to the adoption, on 19 June 2013, of the contested decision, as they are described, in particular, in Section 2.1 thereof:

–        in October 2003, the Commission first became aware of the agreements in question through information from the KFST;

–        in January 2005, the Commission conducted inspections in Denmark, Italy and Hungary, principally on Lundbeck’s premises;

–        in 2006, requests for information were sent to the competition authorities of all the Member States, and to Lundbeck and a generic undertaking;

–        in 2007, the Commission examined the replies to those requests and established a preliminary position in respect of Lundbeck’s practices and those of other undertakings involved;

–        in January 2008, the Commission decided to launch a sector inquiry into the pharmaceutical sector, which was closed with the adoption of a final report on 8 July 2009 (see paragraphs 19 and 20 above);

–        in December 2009, the Commission conducted new inspections at the premises of Lundbeck Italia SpA and Italian generic undertakings;

–        on 7 January 2010, the Commission opened formal proceedings against Lundbeck;

–        on 12 March 2010, the Commission notified the applicants of the existence of the investigation;

–        on 24 July 2012, the Commission opened formal proceedings against, amongst others, the applicants and sent them and Lundbeck a statement of objections.

364    It suffices to note that the second phase lasted under one year in respect of the applicants, which cannot be considered excessive.

365    It must be observed that the first phase began, in respect of the applicants, in March 2010, when the Commission took the initial measures implying an accusation of infringement, and was closed on 24 July 2012, the date of the statement of objections. That duration is not unreasonable.

366    First, in so far as the applicants base their plea on the date on which the Commission first became aware of the agreement at issue in order to establish that the Commission failed to fulfil its obligation to adopt a decision within a reasonable period and thus infringed their rights of defence, it must be stressed that nowhere is that approach followed in the case-law, which takes as its starting point the date of the initial measures implying an accusation of infringement (see, to that effect, judgment in Technische Unie v Commission, cited in paragraph 360 above, EU:C:2006:593, paragraph 43).

367    It must also be noted that Article 25(1)(b) of Regulation No 1/2003 provides that the Commission’s powers to impose fines are subject to a limitation period of five years. Under Article 25(2) of that regulation, time is to begin to run in the case of continuing infringements, as in the present case, on the day on which the infringement ceases. Under Article 25(3) and (4) of that regulation, requests for information, the initiation of proceedings and the notification of the statement of objections interrupt the limitation period, as regards all the participants in an infringement. Under Article 25(5) of Regulation No 1/2003, each interruption is to start time running afresh, but the limitation period is to expire at the latest on the day on which a period equal to twice the limitation period has elapsed without the Commission having imposed a fine or a periodic penalty payment: the Commission therefore cannot put off a decision on fines indefinitely without incurring the risk of the limitation period expiring.

368    Where there is a complete system of rules covering in detail the periods within which the Commission is entitled, without undermining the fundamental requirement of legal certainty, to impose fines on undertakings which are the subject of procedures under the competition rules, there is no room for consideration of the Commission’s duty to exercise its power to impose fines within a reasonable period (see, to that effect and by analogy, judgment of 19 March 2003 in CMA CGM and Others v Commission, T‑213/00, ECR, EU:T:2003:76, paragraph 324 and the case-law cited).

369    Secondly, it should be noted that the duration of the first phase, assuming that it may be calculated from the end of the infringement as the applicants propose, would be almost seven years in the applicants’ case. That period can be justified by the particular circumstances of the present case, from which it can be seen that, in addition to numerous requests for information, the Commission considered it necessary to conduct a sector inquiry in order to examine all the practices concerning settlements in the pharmaceutical sector and obtain a detailed view of the competitive environment in that sector. Thus, in the whole of the procedure specifically concerning the agreements in question there was no period of prolonged inactivity that could not be justified by the Commission’s need to carry out a more general inquiry into the sector concerned.

370    Thirdly, as regards the KFST press release, which suggested, according to the applicants, that the Commission would not initiate any proceedings against them, it must be observed that, in the light of the considerations set out in paragraphs 273 to 278 above in that regard, the applicants cannot reasonably claim that such a press release encouraged them not to take measures to defend themselves, still less that such encouragement, if established, would be attributable to the Commission and the excessive duration of the administrative proceedings before it.

371    Fourthly, it must be pointed out that the applicants merely submit generally that they could have produced internal emails and other documents, the correspondence at the time with Lundbeck, the agendas and minutes of meetings which took place at the relevant time and statements from their employees.

372    In that regard, even if the applicants’ claims fulfilled the conditions of precision and specificity required by the case-law referred to in paragraph 361 above, it must be noted that, in view of the KFST press release and the sector inquiry opened by the Commission, a diligent undertaking should have retained any documents that might prove useful in its defence in the event of proceedings being initiated in respect of an infringement of competition law, at least until the expiry of the maximum limitation period prescribed by EU law (see paragraph 367 above), irrespective of any limitation period that might be in force under the laws of the Member States.

373    Diligence is among the conditions which the case-law (see paragraph 362 above) requires a party to meet in order to be able successfully to plead infringement of its rights of defence owing to the allegedly unreasonable length of the proceedings.

374    As the applicants have failed to give details about the occurrence of specific events which might explain why the documents in question have gone astray, other than the mere passage of time, their argument cannot be upheld.

375    In those circumstances, the present part must be rejected in so far as it seeks the annulment of the contested decision.

376    Moreover, even if, first, the present part could be interpreted as also requesting the Court to reduce the amount of the fine imposed on the applicants even in the absence of an illegality justifying the annulment of the contested decision and, secondly, the case-law of the Court of Justice (see, to that effect, judgment of 8 May 2014 in Bolloré v Commission, C‑414/12 P, EU:C:2014:301, paragraphs 106 and 107) could be interpreted as not precluding the Court, in the exercise of its unlimited jurisdiction, from reducing a fine in order to censure solely an infringement of the rights of the defence, it must be noted that the Commission has already taken into account the duration of the administrative proceedings and has accordingly granted a 10% reduction in the amount of the fines imposed on the applicants and other addressees of the contested decision (see paragraph 33 above). The Court therefore considers, in the exercise of its unlimited jurisdiction, that it is not in any event appropriate further to reduce the amount of the fine for which the applicants are liable.

377    In the light of the foregoing, the present part must also be rejected as regards the exercise, by the Court, of its unlimited jurisdiction, as must the fourth plea in law in its entirety.

378    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 and since the examination of the arguments put forward in support of their application for variation of that decision has not revealed inappropriate elements in the Commission’s calculation of the amount of the fine, the action must be dismissed in its entirety.

 Costs

379    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. As the applicants have been unsuccessful, they must be ordered to pay the costs, in accordance with the form of order sought by the Commission.

On those grounds,

THE GENERAL COURT (Ninth Chamber)

hereby:

1.      Dismisses the action;

2.      Orders Sun Pharmaceuticals Industries Ltd and Ranbaxy (UK) Ltd to pay the costs.

Delivered in open court in Luxembourg on 8 September 2016.

[Signatures]

Table of contents

Background to the dispute

The companies involved in the present case

The relevant product and the applicable patents

The agreement concluded between Lundbeck and Ranbaxy Laboratories

Steps taken by the Commission in the pharmaceutical sector and administrative procedure

The contested decision

Procedure and forms of order sought

Law

The second plea in law, alleging a manifest error of assessment as regards potential competition

Analysis relating to potential competition in the contested decision

Applicable principles and case-law

– Potential competition

– The burden of proof

– The extent of the Court’s review

The time frame of potential competition

The minutes of the meeting of 17 April 2002 and the other evidence used by the Commission.

On the period necessary for the applicants’ API to be covered by an MA

The presumption of validity of the amide and iodo patents

The applicants’ remaining arguments

The third plea in law, alleging manifest errors of assessment in the interpretation of the agreement at issue

The relevance of the fact that the agreement at issue is subject to Swedish law

The meaning of the phrase ‘any production method used by Ranbaxy’

The meaning of the phrase ‘pharmaceutical products’

The first plea in law, alleging that the agreement at issue is not a restriction by object

Preliminary observations

The analysis relating to the existence of a restriction of competition by object in the contested decision

The existence of a restriction by object in the present case

– The classification of the agreement at issue as a settlement agreement

– The allegedly pro-competitive character of the agreement at issue

– The analogies with the case that gave rise to the BIDS judgment

– The intentions of the parties to the agreement at issue

– The lack of precedents and the absence of legal certainty

– Infringement of the principle of protection of legitimate expectations

– Lundbeck’s refusal to purchase the applicants’ API

– The United States case-law

The fourth plea in law, alleging that the fine is unjustified and disproportionate

The first part, alleging that the contested decision is novel and that there has been a breach of the principle of legal certainty, the principle that penalties must have a proper legal basis, the principle of non-retroactivity and the principle of protection of legitimate expectations

The second part, alleging a breach of the 2006 Guidelines

The third part, alleging that the duration of the investigation was unreasonable

Costs

* Language of the case: English.

© European Union
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