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 — Agreements concluded between a patent holder and a generic undertaking — Error of law — Error of assessment — Imputability of infringements — Liability of a parent company for infringements of the competition rules committed by its subsidiaries — Legal certainty — Reasonable time — Fines)

In Case T‑470/13,

Merck KGaA, established in Darmstadt (Germany), represented initially by B. Bär-Bouyssière, K. Lillerud, L. Voldstad, B. Marschall, P. Sabbadini, R. De Travieso, M. Holzhäuser and S. O, lawyers, M. Marelus, Solicitor, and R. Kreisberger and L. Osepciu, Barristers, and subsequently by B. Bär-Bouyssière, L. Voldstad, M. Holzhäuser, A. Cooke, M. Gampp, lawyers, M. Marelus, R Kreisberger and L. Osepciu,

applicant,

v

European Commission, represented initially by J. Bourke, F. Castilla Contreras and T. Vecchi, and subsequently by F. Castilla Contreras, T. Vecchi, B. Mongin and C. Vollrath, acting as Agents, assisted by S. Kingston, Barrister,

defendant,

supported by

Generics (UK) Ltd, established in Potters Bar (United Kingdom), represented initially by G. Drauz, M. Rosenthal and B. Record, lawyers, and subsequently by G. Drauz and M. Rosenthal,

intervener,

APPLICATION for annulment 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 applicant 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 8 October 2015,

gives the following

Judgment

 Summary of the facts and background to the dispute

I –  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’ undertaking, namely an undertaking whose activities are focused on researching new medicinal products and bringing them to the market.

3        Merck KGaA (‘Merck’ or ‘the applicant’) is a company governed by German law specialising in the pharmaceutical sector which, at the time the agreements concerned were concluded, indirectly held 100% — through the group Merck Generics Holding GmbH (‘Merck Generics’) — of its subsidiary Generics UK Limited (‘GUK’ or ‘the intervener’), a company responsible for the development and marketing of generic pharmaceutical products in the United Kingdom. The Commission regarded Merck and GUK as constituting a single undertaking for the purpose of competition law at the time of the infringement (‘Merck (GUK)’).

II –  The relevant product and the applicable patents

4        The relevant product for the purposes of the present case is the antidepressant medicinal product containing the active pharmaceutical ingredient (‘API’) citalopram.

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

6        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 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.

7        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).

8        Thus, 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 in a number of Member States during the first half of 2002, in particular on 30 January 2002 in the case of the United Kingdom (‘the crystallisation patent’). The EPO granted a crystallisation patent on 4 September 2002.

9        Lastly, Lundbeck planned to launch a new antidepressant medicinal product, Cipralex, based on the escitalopram API (or S-citalopram), by the end 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.

III –  The agreements at issue

10      During 2002 Lundbeck entered into six agreements concerning citalopram (‘the agreements in question’) with four undertakings active in the production and/or sale of generic medicinal products (‘the generic undertakings’), including Merck (GUK).

11      The first agreement between Lundbeck and Merck (GUK) came into effect on 24 January 2002, for a period of one year, and covered only the territory of the United Kingdom (‘the UK agreement’). That agreement was subsequently extended for a period of six months, ending on 31 July 2003. Next, after Merck (GUK) briefly entered the United Kingdom market between 1 and 4 August 2003, a second extension of the agreement was signed by the parties on 6 August 2003, for a maximum period of six months, which could be reduced if Lundbeck failed to initiate legal proceedings against other generic undertakings which attempted to enter the market or on determination of the litigation between Lundbeck and Lagap Pharmaceuticals Ltd, another generic undertaking (‘Lagap’ and ‘the Lagap litigation’).

12      According to the terms of the UK agreement:

–        there was a risk that certain actions envisaged by GUK in respect of the marketing, distribution and sale of the ‘Product’ might constitute an infringement of Lundbeck’s intellectual property rights and could give rise to claims on the part of Lundbeck (Article 2.1 of the UK agreement), the ‘Products’ being defined in Article 1.1 of the agreement as ‘the citalopram products developed by GUK in raw material, bulk product and finished pack form as set out in the Schedule and manufactured in accordance with the specification for Products as supplied by GUK at the date of signature. Attached to Schedule 2’;

–        Lundbeck would pay GUK the sum of 2 million pounds sterling (GBP), in consideration for the delivery of the ‘Products’, in the quantities set out in the agreement, on 31 January 2002 (Article 2.2 of the UK agreement);

–        GUK also undertook, in consideration of a further payment of GBP 1 million, to deliver the ‘Products’, as specified in the schedule, on 2 April 2002 (Article 2.3 of the UK agreement);

–        the payments made and the delivery of the ‘Products’ by GUK pursuant to Articles 2.2 and 2.3 of the agreement would constitute full and final settlement of any claim that Lundbeck might have against GUK for infringement of its intellectual property rights in connection with the ‘Products’ delivered by GUK up to that date (Article 2.4 of the UK agreement);

–        Lundbeck undertook to sell its ‘Finished Products’ to GUK and GUK undertook to purchase those ‘Finished Products’ exclusively from Lundbeck for resale by GUK and its affiliates in the United Kingdom during the term and subject to the conditions of the agreement (Article 3.2 of the UK agreement), those ‘Finished Products’ being defined in paragraph 1.1 of the agreement as ‘products containing citalopram in finished pack form to be supplied by [Lundbeck] to GUK pursuant to this Agreement’;

–        Lundbeck undertook to pay the sum of GBP 5 million guaranteed net profits to GUK, on condition that GUK ordered the agreed volume of ‘Finished Products’ during the term of the agreement (or a lesser amount to be calculated pro rata to the volume ordered) (Article 6.2 of the UK agreement).

13      The first extension of the UK agreement provided, in particular, for monthly payments of the sum of GBP 400 000 per month for the implementation of Article 6.2 of the agreement by GUK and amended the definition of ‘net profits’.

14      The second extension of the UK agreement provided, in particular, for monthly payments of the sum of GBP 750 000 per month for the implementation of Article 6.2 of that agreement by GUK. 

15      The UK agreement expired on 1 November 2003, following the settlement of the Lagap litigation. In total, over the entire term of the agreement, Lundbeck transferred the equivalent of EUR 19.4 million to GUK. 

16      A second agreement was concluded between Lundbeck and GUK on 22 October 2002, covering the EEA excluding the United Kingdom (‘the EEA agreement’). That agreement provided for payment of the sum of EUR 12 million, in consideration whereof GUK undertook not to sell or supply pharmaceutical products containing citalopram throughout the EEA (excluding the United Kingdom) and to use all reasonable efforts to ensure that Natco Pharma Ltd (‘Natco’) — the manufacturer of the generic citalopram that Merck (GUK) had intended to market (‘the Natco citalopram’) — ceased to supply citalopram and products containing citalopram in the EEA during the term of the agreement (Articles 1.1 and 1.2 of the EEA agreement). Lundbeck undertook not to bring legal proceedings against GUK, on condition that it complied with its obligations under Article 1.1 of the agreement (Article 1.3 of the EEA agreement).

17      The EEA agreement expired on 22 October 2003. In total, Lundbeck transferred the equivalent of EUR 12 million to GUK under that agreement.

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

18      In October 2003, the Commission of the European Communities was informed of the agreements at issue by the Konkurrence- og Forbrugerstyrelsen (the Danish authority for competition and consumers, ‘the KFST’).

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

20      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 [EC] and 102 [EC] (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.

21      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.

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

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

24      In 2010 and the first half of 2011, the Commission sent requests for information to Lundbeck and, among others, to the companies which were parties to the agreements in question, including the applicant.

25      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.

26      All the addressees of that statement of objections who had requested a hearing were heard at the hearings on 14 and 15 March 2013.

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

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

29      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’).

V –  Contested decision

30      By the contested decision, the Commission considered that the UK agreement and the EEA agreement (together ‘the agreements at issue’), as well as the other agreements in question, constituted a restriction of competition ‘by object’ within the meaning of Article 101(1) TFEU and Article 53(1) of the EEA Agreement (Article 1(1) of the contested decision). The agreements at issue were considered to have constituted a single and continuous infringement lasting from 24 January 2002 until 1 November 2003.

31      As is apparent from the summary set out in recitals 824 and 874 of the contested decision, the Commission relied, in particular, on the following factors:

–        at the time of concluding the agreements at issue, Lundbeck and Merck (GUK) were at least potential competitors in the United Kingdom and in the EEA and actual competitors in the United Kingdom before the second extension of the UK agreement;

–        Lundbeck transferred significant value to Merck (GUK) pursuant to those agreements;

–        that transfer of value was linked to the acceptance by Merck (GUK) of the limitations on its market entry set out in those agreements, notably its commitment not to sell the Natco citalopram or any other generic citalopram in the United Kingdom and in the EEA during the period concerned;

–        that transferred value corresponded approximately to the profits Merck (GUK) expected to make if it had successfully entered the market;

–        Lundbeck could not have obtained those limitations on entry through enforcement of its process patents, since the obligations on Merck (GUK) under the agreements at issue went beyond the rights granted to holders of process patents;

–        the agreements at issue contained no commitment from Lundbeck to refrain from infringement proceedings if Merck (GUK) entered the market with generic citalopram after the expiry of the agreements at issue.

32      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’). In Lundbeck’s case, the Commission followed the general methodology described in the 2006 Guidelines, based on the value of sales of the relevant product made by each participant in an infringement (recitals 1316 to 1358 of the contested decision). In the case of the other parties to the agreements in question, 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).

33      Thus, as regards the parties to the agreements in question other than Lundbeck, including Merck (GUK), 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 the agreements in question, 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). In order to take account of the distribution costs incurred by Merck (GUK), the Commission nonetheless applied a reduction of 10% to that undertaking’s turnover (recital 1373 of the contested decision).

34      In view of the total length of the investigation, the Commission granted a reduction of 10% of the fines imposed on all the addressees of the contested decision (recitals 1349 and 1380 of the contested decision).

35      In the light of the separation of Merck from GUK in 2007, the Commission applied the maximum amount of 10% of turnover provided for in Article 23(2) of Regulation No 1/2003 separately to Merck and GUK (recital 1382 to the contested decision).

36      On the basis of those considerations, the Commission imposed a fine of EUR 21 411 000 on Merck, of which EUR 7 766 843 jointly and severally with GUK (Article 2(1) of the contested decision).

 Procedure and forms of order sought

37      By application lodged at the Court Registry on 30 August 2013, the applicant brought the present action.

38      By order of the President of the Ninth Chamber of 20 May 2014, GUK was granted leave to intervene in the present proceedings, in support of the form of order sought by the Commission as regards the rejection of the applicant’s 10th plea, whereby it seeks to impute liability to the applicant as the former parent company of GUK.

39      The written stage of the procedure was closed on 18 September 2014.

40      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).

41      The parties complied with that request within the prescribed period.

42      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 provided for in Article 89 of its Rules of Procedure, put a number of questions to the parties, to be answered in writing.

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

44      The parties presented oral argument and answered the oral questions put to them by the Court at the hearing on 8 October 2015.

45      The applicant claims that the Court should:

–        annul Article 1(1) and Article 2(1) of the contested decision, and also Article 2(5) and Articles 3 and 4 of that decision, in so far as they apply to the applicant;

–        in the alternative, annul or reduce the amount of the fine imposed on it;

–        in any event, order the Commission to pay the costs.

46      The Commission contends that the Court should:

–        dismiss the application;

–        order the applicant to pay the costs.

47      The intervener claims that the Court should dismiss the application in so far as it concerns the applicant’s tenth plea in law.

 Law

48      The applicant puts forward thirteen pleas in law in support of its action.

49      By its first plea in law, the applicant alleges that the Commission erred in its interpretation of the concept of a restriction by object within the meaning of Article 101 TFEU. The applicant alleges, by its second plea in law, that the theory of harm applied by the Commission is fundamentally flawed, by its third plea in law, that the Commission’s approach is contrary to the principle of legal certainty, and by its fourth plea in law, that the Commission erred in failing to take proper account of the factual, economic and legal context, which shows that in the absence of the agreements Merck (GUK) would not have launched citalopram any more quickly in the United Kingdom or other EEA markets. By its fifth plea in law, the applicant alleges that the Commission erred in its assessment of the scope of the agreements at issue. By its sixth plea in law, the applicant alleges that the Commission erred in law and in fact in finding that Lundbeck and Merck (GUK) were potential competitors. By its seventh plea in law, the applicant alleges that the Commission made a manifest error of assessment in concluding that Merck (GUK) had an anticompetitive intention in concluding the agreements at issue. By its eighth plea in law, the applicant alleges that the Commission erred in fact in its findings as to the size and purpose of the value transfer between Lundbeck and Merck (GUK). By its ninth plea in law, the applicant alleges that the Commission did not properly assess the arguments raised by the parties under Article 101(3) TFEU. By its tenth plea in law, the applicant alleges that the Commission failed to have due regard to evidence from Merck rebutting the presumption of decisive influence over its subsidiary GUK and, consequently, erred in fact and law in finding that that presumption was not rebutted. The applicant alleges, by its eleventh plea in law, a breach of the ‘reasonable time’ requirement, by its twelfth plea in law, a breach of the parties’ right to be heard, and by its thirteenth plea in law, that the Commission erred in its assessment of the penalties.

50      Since some of those pleas in law and some of the arguments put forward in support of them overlap, it is appropriate to examine first of all the applicant’s arguments raised in the context of the fourth and sixth pleas in law relating, in essence, to the examination in the contested decision of the potential competition between Merck (GUK) and Lundbeck.

51      It is appropriate to examine, next, the arguments raised in the context of the first, second, fourth, fifth, seventh and eighth pleas in law relating to the concept of restriction by object for the purpose of Article 101(1) TFEU and the manner in which that concept was applied by the Commission in the contested decision and, lastly, the tenth, third, eleventh and thirteenth pleas in law, in that order.

52      As a preliminary point, it is necessary to examine the admissibility of the ninth and twelfth pleas in law, as this has been challenged by the Commission.

I –  The admissibility of the ninth and twelfth pleas in law, alleging an infringement of Article 101(3) TFEU and a breach of the parties’ right to be heard.

53      The applicant merely states, in the context of the ninth plea, that the Commission did not correctly assess its arguments relating to the application of Article 101(3) TFEU to the agreements at issue, in breach of the legal principles laid down by the Court of Justice in the judgment of 6 October 2009 in GlaxoSmithKline Services and Others v Commission and Others (C‑501/06 P, C‑513/06 P, C‑515/06 P and C‑519/06 P, ECR, EU:C:2009:610, paragraph 83). It refers generally to the arguments raised in that respect by GUK in its action in Case T‑469/13, Generics (UK) v Commission.

54      In the context of the 12th plea, the applicant submits that it was not given the opportunity to respond to a number of objections formulated for the first time in the contested decision and amending the Commission’s findings as set out in the statement of objections. The applicant also refers in that regard to the arguments put forward by GUK in its application in the pending Case T‑469/13, Generics (UK) v Commission.

55      The Commission submits that those two pleas in law are inadmissible; the applicant has not responded to that submission.

56      It must be recalled that, pursuant to Article 21 of the Statute of the Court of Justice of the European Union and Article 44(1) of the Rules of Procedure of 2 May 1991, an application must contain the subject matter of the proceedings, the pleas in law and arguments relied on and a summary of those pleas in law. That statement must be sufficiently clear and precise to enable the defendant to prepare his defence and the Court to rule on the application, if necessary, without any further information. In order to guarantee legal certainty and sound administration of justice it is necessary, in order for an action to be admissible, that the basic legal and factual particulars relied on be indicated, at least in summary form, coherently and intelligibly in the application itself (see, to that effect, order of 25 July 2000 in RJB Mining v Commission, T‑110/98, ECR, EU:T:2000:199, paragraph 23, and judgment of 3 February 2005 in Chiquita Brands and Others v Commission T‑19/01, ECR, EU:T:2005:31, paragraph 64).

57      In that regard, while the body of the application may be supported and supplemented on specific points by references to extracts from documents annexed thereto, a general reference to other documents, even those annexed to the application, cannot make up for the absence of the essential arguments in law which, in accordance with the abovementioned provisions, must appear in the application (order of 21 May 1999 in Asia Motor France and Others v Commission, T‑154/98, ECR, EU:T:1999:109, paragraph 49).

58      It must be pointed out that, in the present case, the ninth and tenth pleas in law are entirely unsupported in the application and are each dealt with in a single paragraph, referring to the arguments made by GUK in the pending Case T‑469/13, Generics (UK) v Commission. Furthermore, the applicant has not put forward any arguments in its reply to clarify those pleas. Although GUK was granted leave to intervene in the present case, the pending Case T‑469/13, Generics (UK) v Commission remains a separate case and was not joined to the present case.

59      Accordingly, in view of the case-law cited above, the ninth and twelfth pleas in law must be rejected as inadmissible.

II –  The sixth plea in law, alleging that the Commission erred in law and in fact in finding that Lundbeck and Merck (GUK) were potential competitors, and the fourth plea in law, in so far as it is based on the same line of argument

60      The applicant maintains, in the first place, that the Commission erred in law in its choice of the relevant test for examining the existence of potential competition in the present case. It submits that, according to the case-law, the relevant test for an undertaking to be considered a potential competitor on a market is that it must have a real and concrete possibility of entering that market, while a purely theoretical possibility of entry is not sufficient for that purpose. The fact that the undertaking intends to enter a market is not decisive in that regard; what is decisive is its ability to enter the market. The Commission itself stated in its Guidelines on the applicability of Article 101 [TFEU] to horizontal cooperation agreements (OJ 2011 C 11, p. 1) that undertakings are not competitors if entry to the market by one of them would be unlawful in that it would infringe the other’s intellectual property rights. The applicant submits that this also follows from Regulation No (EC) No 772/2004 of 27 April 2004 on the application of Article [101(3) TFEU] to categories of technology transfer agreements (OJ L 123, p. 11), and from the Guidelines on the application of Article 81 of the EC Treaty to technology transfer agreements (OJ 2004 C 101, p. 2), according to which non-challenge clauses included in settlement agreements are considered to fall outside the scope of Article 101(1) TFEU. 

61      In addition, the applicant maintains that the Commission erred in law in relying on the fact that Lundbeck perceived Merck (GUK) as a potential competitor as a basis for finding the existence of potential competition. The notion of potential competition is an objective notion and the subjective perception of one of the parties cannot be regarded as a relevant factor for that purpose. The Commission’s reference in the contested decision to the judgment of 12 July 2011 in Hitachi and Others v Commission (T‑112/07, ECR, EU:T:2011:342) is inappropriate, since, in the case that gave rise to that judgment, the question was whether there had been a ‘common understanding’ between the European and the Japanese suppliers of gas insulated switchgear. Likewise, the reference to the judgment of 6 December 2012 in AstraZeneca v Commission (C‑457/10 P, ECR, EU:C:2012:770) is misleading, since, unlike the situation in the case that gave rise to that judgment, it has not been established in the present case that the patents at issue were obtained fraudulently or illegally.

62      In the second place, the applicant maintains that the Commission made an error of fact in concluding that there was a ‘real and concrete’ possibility that Merck (GUK) could enter the United Kingdom and EEA markets and compete with Lundbeck.

63      In the third place, the applicant submits that the Commission was wrong to conclude that there was actual competition between Lundbeck and Merck (GUK) at the material time. Merck (GUK)’s sales in the United Kingdom between 1 and 4 August 2003 were made ‘at risk’ and Lundbeck would inevitably have brought legal proceedings and sought interim measures against Merck (GUK) if the UK Agreement had not been extended on 7 August 2003. Furthermore, the fact that NM Pharma, an independent company with no structural links with Merck (GUK), had begun to market the generic at risk in Sweden is also irrelevant, since Merck (GUK) had asked it to suspend its sales of the generic product.

64      The Commission disputes those arguments.

65      Before examining the applicant’s arguments, it is appropriate to give a brief summary of the relevant case-law and of the approach taken by the Commission in the contested decision as regards the potential competition between Merck (GUK) and Lundbeck.

A –  Analysis relating to potential competition in the contested decision

66      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.

67      The first phase may begin several years before the 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 production 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 marketing authorisations (MAs) pursuant to 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 L 311, p. 67), 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.

68      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 those 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.

69      In those two 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.

70      In recitals 621 to 623 of the contested decision, the Commission noted that, in the present case, Lundbeck’s 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. In the light of those factors, the Commission took the view that the generic undertakings were exerting competitive pressure on Lundbeck at the time the agreements at issue were concluded.

71      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, the 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 in a prima facie fashion, that those products infringe one of its patents, in order to obtain a court injunction prohibiting the generic undertakings from making any further sales of those products on the market. In the present case, the Commission considered, relying inter alia on the assessments of the parties to the agreements at issue, that the crystallisation patent, on which Lundbeck heavily relied in order to block the market entry of generics in the United Kingdom, had a 60% chance of being held invalid by a court and that it was not perceived as novel by the generic undertakings. In those circumstances, the Commission considered that the possibility for generic undertakings to enter the market ‘at risk’ and potentially face infringement actions brought by Lundbeck was an expression of potential competition. Accordingly, the Commission concluded that Lundbeck’s process patents were not capable of blocking all possibilities of market entry open to the generic undertakings.

72      In recital 635 of the contested decision, the Commission identified eight possible routes to the market in the present case, namely:

–        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 — in the case of Merck (GUK), Schweizerhall Pharma International GmbH (‘Schweizerhall’) — to change the API producers’ process in such a way as to eliminate or reduce the risk of infringement of the originator undertaking’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 permitted it or possibly because an exclusive supply contract could be invalidated if the supplied API were found to infringe Lundbeck’s process patents.

73      As regards, in particular, the examination of the competitive relationship between Lundbeck and Merck (GUK) at the time the agreements at issue were concluded, the Commission made a distinction, in the contested decision, between the situation in the United Kingdom and the situation in the EEA.

1.     The situation in the United Kingdom

74      As regards, first of all, the competitive situation in the United Kingdom, the Commission found that, during the period preceding 24 January 2002, the date on which the UK agreement was signed, Lundbeck was the only undertaking selling citalopram in the United Kingdom. On 5 January 2002, Lundbeck’s original patents expired in the United Kingdom. From that date, the citalopram market in the United Kingdom was therefore in principle open to generic products containing citalopram, provided that they complied with the legal requirement in relation to quality, safety and efficacy, as confirmed by an MA. The Commission therefore took the view that undertakings manufacturing or intending to sell genetic citalopram products in the United Kingdom which had a realistic prospect of obtaining supplies of generic citalopram and acquiring an MA in the near future could be regarded as potential competitors of Lundbeck. The market entry of generics, in particular by several generic undertakings simultaneously, would in all probability have generated an intense process of price competition that would have reduced citalopram prices quickly and steeply (recital 738 of the contested decision).

75      Merck (GUK), after informing Lundbeck of its intention to enter the citalopram market, was the first generic undertaking to obtain an MA for the United Kingdom, on 9 January 2002. During that period, Merck (GUK) had assembled a stock of 8 million citalopram tablets produced by Natco and ready to be sold in the United Kingdom (recital 741 of the contested decision).

76      Following the conclusion of the UK agreement with Lundbeck on 24 January 2002, Merck (GUK) abstained from launching generic citalopram on the market until the end of the term of the agreement, which was initially planned for July 2003. Nevertheless, between 1 and 4 August 2003, before the agreement was extended for a second time on 6 August 2003, Merck (GUK) indeed sold generic citalopram in the United Kingdom corresponding to GBP 3.3 million (recital 742 of the contested decision).

77      The Commission concluded, in recital 743 of the contested decision, that those facts sufficiently demonstrated that Merck (GUK) had real concrete possibilities of entering the citalopram market in the United Kingdom at the time the agreements at issue were concluded. In addition, according to the Commission, the fact that Merck (GUK) briefly entered the market in August 2003 sufficiently demonstrated that Merck (GUK) and Lundbeck were potential competitors at the time the agreements at issue were concluded in January 2002. Furthermore, the very fact that Lundbeck agreed to transfer considerable value to Merck (GUK) under those agreements demonstrated that Lundbeck perceived Merck (GUK) as a potential competitor, the market entry of which was plausible, and which constituted a threat to its position on the citalopram market at the time the agreements at issue were concluded.

2.     The situation in the EEA

78      As regards the competitive situation in the EEA, the Commission set out, in recital 827 et seq. of the contested decision, the reasons why it considered that Merck (GUK) could be regarded as a potential competitor of Lundbeck in most of the EEA States. On 15 May 2001, Merck (GUK) had concluded an exclusive supply agreement with Schweizerhall concerning the generic citalopram produced by Natco (‘the Schweizerhall agreement’). Under that agreement Schweizerhall became the preferred supplier of Natco for a number of EEA States (namely Belgium, Germany, Spain, France, Italy, the Netherlands, Finland, Sweden and Norway) and Merck (GUK) became its ‘preferred customer’, meaning that Merck (GUK) would cover 100% of its annual generic citalopram supply needs with Schweizerhall and that those needs would be given priority (recital 235 of the contested decision).

79      In May 2002, NM Pharma, Merck (GUK)’s distributor for Sweden, obtained an MA and entered the Swedish market. NM Pharma also had a strong distribution network in Norway and intended to use its Swedish MA to obtain MAs in Belgium, Denmark, Spain, the Netherlands, Finland and Norway, through the mutual recognition procedure laid down in Directive 2001/83. Merck (GUK), for its part, intended to obtain similar MAs for Ireland, France, Germany, Austria, Italy, Portugal and Greece, by using its MA obtained in the United Kingdom (recitals 829 and 830 of the contested decision). In addition, the Commission relied on point D of the preamble to the EEA agreement, which recognised Merck (GUK)’s role as a potential competitor in the EEA (recital 831 of the contested decision).

80      Those are the factors on the basis of which the Commission concluded that Merck (GUK) and Lundbeck were at the very least potential competitors at the time the EEA agreement was signed in October 2002. Merck (GUK) was even an actual competitor of Lundbeck in Sweden for several months preceding the signing of the agreement, through its distributor NM Pharma. Moreover, the very fact that Lundbeck agreed to transfer considerable value to Merck (GUK) under that agreement sufficiently demonstrated that Lundbeck perceived Merck (GUK) as a potential competitor, the market entry of which was plausible, and which constituted a threat to its position on the market at the time the EEA agreement was signed (recital 832 of the contested decision).

B –  Applicable principles and case-law

1.     The concept of potential competition

81      It must be noted, first of all, 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).

82      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, of 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 81 above, EU:T:2012:332, paragraph 85).

83      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 factual 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 81 above, EU:T:2012:332, paragraph 86 and the case-law cited).

84      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 81 above, EU:T:2012:332, paragraph 87 and the case-law cited).

85      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 82 above, EU:T:2011:181, paragraph 169).

86      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 in Hitachi and Others v Commission, cited in paragraph 61 above, EU:T:2011:342, paragraph 226, and of 21 May 2014 in Toshiba v Commission, T‑519/09, EU:T:2014:263, paragraph 231).

87      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 factual 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 81 above, EU:T:2012:332, paragraphs 106 and 114).

2.     The burden of proof

88      It follows from settled case-law, and from Article 2 of Regulation No 1/2003, that it is for the party or the authority alleging an infringement of the competition rules to prove its existence. Thus, 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).

89      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 88 above, EU:T:2013:188, paragraph 92 and the case-law cited).

90      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 88 above, EU:T:2013:188, paragraph 93 and the case-law cited).

91      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 88 above, EU:T:2013:188, paragraph 95 and the case-law cited).

92      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 88 above, EU:T:2013:188, paragraph 96 and the case-law cited).

93      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 88 above, EU:T:2013:188, paragraph 97 and the case-law cited).

94      Lastly, it must be pointed out that, when the Commission establishes that an undertaking 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).

95      Nevertheless, 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 88 above, EU:T:2013:188, paragraphs 99 and the case-law cited).

3.     The extent of the Court’s review

96      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 the applicant 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).

C –  The potential competition between Merck (GUK) and Lundbeck

97      The applicant’s arguments concerning the absence of potential competition between Merck (GUK) and Lundbeck at the time the agreements were concluded must be examined in the light of those considerations.

98      As a preliminary point, it is necessary to confirm the Commission’s approach, as 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 agreements at issue were 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 those agreements. Secondly, the parties to those agreements 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 agreements at issue.

99      The Commission therefore did not err in evaluating the competitive situation between Merck (GUK) and Lundbeck as it was at the time the agreements were concluded; subsequent evidence can always also be taken into account provided that it allows the position of those undertakings at the material time to be better established, supports or undermines those undertakings’ argument in that respect or enables a better understanding of the operation 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 agreements at issue.

1.     The application of the appropriate legal test to the present case and the taking into account of Lundbeck’s perception in order to find the existence of potential competition between Merck (GUK) and Lundbeck

100    The applicant submits that the Commission did not apply the correct legal test in the present case in order to assess whether there was potential competition between Merck (GUK) and Lundbeck.

101    That allegation must be rejected.

102    It is clear from the contested decision that, in order to establish the existence of potential competition in the present case, the Commission relied on the case-law established in the judgments in European Night Services and Others v Commission, cited in paragraph 82 above (EU:T:1998:198), and Visa Europe and Visa International Service v Commission, cited in paragraph 82 above (EU:T:2011:181), according to which it must be examined whether, given 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 (recitals 610 and 611 of the contested decision).

103    The Commission also rightly noted, in recital 612 of the contested decision, that the essential factor in that respect was the need for the potential entry to take place with sufficient speed to form a constraint on market participants (judgment in Visa Europe and Visa International Service v Commission, cited in paragraph 82 above, EU:T:2011:181, paragraph 189).

104    The applicant nevertheless submits that the Commission committed an error of fact and of law in taking account of the fact that Lundbeck perceived Merck (GUK) as a potential competitor in order to find the existence of potential competition between them, relying inter alia on the judgment in Hitachi and Others v Commission, cited in paragraph 61 above (EU:T:2011:342).

105    In the case that gave rise to that judgment, the Court held that the very existence of a notification and project loading mechanism in proving the existence of the common understanding concerning gas insulated switchgear, involving Japanese producers, constituted a serious indicator that the Japanese producers were perceived by the European producers as potential credible competitors on the EEA market (judgment in Hitachi and Others v Commission, cited in paragraph 61 above, EU:T:2011:342, paragraph 226).

106    Accordingly, the Commission did not err in considering that the perception of market operators and the very existence of an agreement between Lundbeck and Merck (GUK) intended to limit the latter’s commercial autonomy by preventing it from entering the market with its generic products constituted relevant factors in assessing the existence of potential competition in the present case.

107    It must be noted, moreover, that the Commission simply pointed out, in recital 614 of the contested decision, that the perception of undertakings already present on the market (incumbents) should play a role in the assessment of whether potential competition exists. The Commission did not take the view, however, that this was the only relevant factor, as the applicant alleges.

108    In the present case, the Commission relied on objective elements, such as the grant of an MA, the steps already taken and the investments already made by Merck (GUK) as well as the large stock of citalopram tablets amassed at the time the agreements at issue were concluded, in order to establish the existence of potential competition between it and Lundbeck (paragraph 74 to 80 above). Moreover, Lundbeck’s perception is described in the contested decision on the basis of objective evidence dating from a period in tempore non suspecto prior to the signing of the agreements at issue.

109    Therefore, contrary to the applicant’s assertions, the Commission did not disregard the case-law according to which the essential factor on which a description of an undertaking as a potential competitor must be based is whether it has the ability to enter the market (paragraph 84 above).

110    Likewise, the reference to the judgment in AstraZeneca v Commission, cited in paragraph 61 above (EU:C:2012:770, paragraph 108), is set out in recital 619 of the contested decision, in the section on potential competition relating to the specific features of the pharmaceutical sector, and is intended to indicate that generic undertakings may become a competitive threat for undertakings already present on the market well before the expiry of the patent on the API.

111    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 patents is independent of the fact that the SPCs at issue in that judgment had been obtained fraudulently or irregularly. 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 allowing it to prevent the market entry of generic version 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 regular 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. Accordingly, that case-law confirms that potential competition already exists before the expiry of the patents protecting a medicinal product and that the steps taken before that expiry are relevant in assessing whether that competition was restricted.

112    As regards the applicant’s argument based on the Commission’s guidelines on the applicability of Article 101 TFEU to horizontal cooperation agreements, Regulation No 772/2004 and the Guidelines on technology transfer agreements (paragraph 60 above), it must be pointed out that, while it is true that Article 1(1)(j)(ii) of Regulation No 772/2004 provides that potential competitors on the product market are undertakings which would, on realistic grounds, undertake the necessary additional investments or other necessary switching costs so that they could timely enter, without infringing each other’s intellectual property rights, the relevant product and geographic markets in response to a small and permanent increase in relative prices, it must be borne in mind that it was in no way established that the applicant’s generic products infringed Lundbeck’s patents, since it was precisely the uncertainty surrounding that issue which was eliminated by the agreements at issue, but which did not prevent, by itself, the applicant from entering the market with those products. As the Commission noted in recital 677 of the contested decision, the Guidelines on technology transfer agreements stated that ‘particularly convincing evidence of the existence of a blocking position [was] required where the parties [could] have a common interest in claiming the existence of a blocking position in order to be qualified as non-competitors’. In any event, the agreements at issue did not provide for the transfer of a Lundbeck technology to Merck (GUK), with the result that those guidelines are not applicable in the present case.

113    Furthermore, contrary to the applicant’s assertions, it can be seen from the evidence on which the contested decision is based, the relevance of which will be examined below, that the Commission did not rely on purely theoretical possibilities in order to establish the existence of potential competition between Merck (GUK) and Lundbeck in the contested decision, but rather it established, on the contrary, that Merck (GUK) had real concrete possibilities of entering the market within a reasonable period and that it constituted a competitive threat to Lundbeck at the time the agreements at issue were concluded.

114    Accordingly, the applicant’s complaint that the Commission did not apply the appropriate legal test in the contested decision in establishing the existence of potential competition between Merck (GUK) and Lundbeck must be rejected.

2.     The existence of a real concrete possibility of Merck (GUK) entering the United Kingdom and EEA markets and entering into competition with Lundbeck

115    The applicant disputes the conclusion that Merck (GUK) and Lundbeck were potential competitors at the time the agreements at issue were concluded and puts forward several arguments in that respect, in the context of the fourth and sixth pleas in law.

a)     The inevitability of litigation with Lundbeck in the event that generic citalopram entered the market:

116    The applicant submits that Lundbeck would inevitably have brought infringement actions against Merck (GUK) if the latter had brought generic citalopram to the market, that Lundbeck’s crystallisation patent gave it a blocking position and that, in the absence of a decision of a court in the United Kingdom declaring that patent invalid, the Commission should have found that there was no potential competition between Merck (GUK) and Lundbeck.

117    In addition, according to the applicant, the very fact of having obtained a new blocking patent shortly before the expiry of the patent would have prevented or suspended the impending potential competition. The applicant disputes the argument that Merck (GUK) was prepared to enter the market before the conclusion of the UK agreement, and submits that those circumstances do not show that Merck (GUK) considered that it was in a position to market its generic version of citalopram at the time the UK agreement was concluded.

118    However, it must be pointed out, first of all, that that argument is intended to call into question the distinction between actual competition and potential competition, since, according to the applicant, there could be no potential competition as long as it was not demonstrated with absolute certainty that, in the absence of the agreements at issue, Merck (GUK) would have entered the market without being sued for infringement by Lundbeck.

119    It must therefore be found in that respect, as the Commission did in recital 635 of the contested decision, that in general the generic undertakings had several routes — constituting real concrete possibilities — to enter the market at the time the agreements at issue were concluded (paragraph 72 above). Those possible routes included, inter alia, launching the generic product ‘at risk’, with the possibility of having to face proceedings brought by Lundbeck.

120    That possibility represents the expression of potential competition, in a situation in which, as in the present case, Lundbeck’s original patents, concerning both the citalopram API and the cyanation and alkylation processes, had expired and where there were other processes allowing the production of generic citalopram that had not been found to infringe other Lundbeck patents (see recitals 248 and 351 of the contested decision). In addition, the steps taken and the investments made by Merck (GUK) in order to enter the citalopram market before concluding the agreements at issue, as set out by the Commission in recital 739 et seq. of the contested decision (paragraph 75 above) — the existence of which has not been contested by the applicant — show that it was ready to enter the market and to accept the risks involved in such an entry.

121    It must also be pointed out that the Commission did not ignore the existence of Lundbeck’s new process patents and, in particular, the crystallisation patent, contrary to the applicant’s assertions.

122    Although it is true, as the Commission acknowledged in recital 745 of the contested decision, that Lundbeck could have argued before the competent national courts that one or several of its process patents had been infringed by the applicant’s generic versions of citalopram, such an infringement still had to be established and the burden of proof in that respect rested on Lundbeck. Moreover, as the Commission noted in the same recital, the generic undertakings such as the applicant could, in the event of litigation, have not only sought to demonstrate that their products did not infringe any of Lundbeck’s process patents, but also sought to call into question the validity of those patents through a counter-claim, if, for example, those patents were actually not innovative or were covered by existing inventions.

123    According to Lundbeck’s reply to the statement of objections, proving the infringement of a process patent was ‘very difficult’ (recital 745 of the contested decision). In a press release of 9 November 2002, Lundbeck’s Vice-President stated that ‘it would be naive to think that it is not possible for producers of generic copies to produce Cipramil without breaking our patent’ (recital 150 of the contested decision). Lastly, it can be seen from Lundbeck’s internal assessments of August and September 2003, issued in the context of the Lagap litigation, that it had itself estimated that there was a 50 to 60% probability that its crystallisation patent would be invalidated in the event of litigation (recital 157 of the contested decision).

124    In those circumstances, it is difficult to dispute that Lundbeck’s process patents, and in particular its crystallisation patent, did not constitute insurmountable barriers for the generic undertakings, such as the applicant, which were ready and willing to enter the citalopram market and which had already made significant investments to that end when the agreements at issue were concluded.

125    It is indeed possible that, in certain cases, Lundbeck might have been successful before the competent courts and obtained injunctions or damages against Merck (GUK). However, it can be seen from the evidence supporting the contested decision that that possibility was not perceived by the applicant as a sufficiently credible threat when the agreements at issue were concluded. The applicant had considered, inter alia, following the publication of Lundbeck’s crystallisation patent, that its generic medicinal product was ‘non-infringing’, that ‘none of the published patent applications ... constitute[d] a problem’ and that, in the light of expert statements, it did ‘not have a patent problem at all’ (recitals 237, 248 and 334 of the contested decision). It can also be seen from an internal email of Merck (GUK) of 13 September 2001 that, when Lundbeck had initially threatened to ‘sue [Merck (GUK)] to hell’ in the event of patent infringement, Merck (GUK) had replied: ‘good luck ... this does not affect us launching [our product]’ (recital 240 of the contested decision).

126    Moreover, the documents in the file also show that there was no certainty that Lundbeck would have actually brought legal proceedings if Merck (GUK) had sold generic citalopram. The contested decision indeed acknowledges that Lundbeck had put in place a general strategy consisting in threatening the generic undertakings with infringement actions or bringing such actions on the basis of its process patents. Nevertheless, any decision to bring an action depended on Lundbeck’s assessment of the probability that an action would be successful and that a marketed generic product would be held to be infringing one of its patents. It can be seen from Lundbeck’s reply to the Commission’s requests for information in the administrative procedure, that ‘generic [manufacturers] could have produced citalopram by using the process described in Lundbeck’s original compound patent ... or they could have invested to invent an entirely new process’ (recital 150 of the contested decision). Furthermore, as regards a possible counter-claim challenging the validity of its crystallisation patent, Lundbeck knew that that patent was ‘not the strongest of all patents’ and that it was considered by its rivals to be ‘high school chemistry’ (recital 149 of the contested decision).

127    In addition, it can be seen from the documents in the file that Lundbeck did not bring proceedings against Merck (GUK) on any of the occasions in which the latter actually entered the market, first in Sweden through its distributor NM Pharma in May 2002, and then in the United Kingdom in August 2003, before the UK Agreement was extended a second time, because Merck (GUK) had initially deemed Lundbeck’s offer ‘not good enough’ (recital 299 of the contested decision) for it to remain outside the market. It is true that, as the applicant submits, that decision not to bring legal proceedings against Merck (GUK) could be justified in view of the extension of the UK agreement. However, it must be pointed out that the EEA agreement was concluded more than five months after NM Pharma had launched its generic product, with ‘very encouraging’ sales (recital 325 of the contested decision) and without facing any legal action from Lundbeck (recital 837 of the contested decision). In that context, it must be noted that, although NM Pharma had been approached by Lundbeck in order to conclude an agreement of the same type as the agreements at issue, it refused to enter into such discussions on the ground that it was contrary to its competition policy (recital 190 of the contested decision).

128    Lastly, it must be pointed out that, even if Lundbeck had brought infringement actions against Merck (GUK) and the latter’s products had been found to be infringing, Merck (GUK) would nevertheless have been able to obtain citalopram which had not been held to be infringing from other sources within a reasonable period. Although the applicant had concluded a supply agreement with Schweizerhall for a period of eight years, that agreement was based on the assumption that Natco’s product was non-infringing (recital 235 of the contested decision), with the result that Merck (GUK) would probably have been able to terminate that agreement in the event of infringement, whether on the basis of the express provisions of that agreement or pursuant to German law, the law applicable to that contract. It can be seen, inter alia, from recitals 248 and 351 of the contested decision that there were other sources of generic citalopram on the market, of which Merck (GUK) was aware, through, inter alia, Merck dura GmbH, Merck’s subsidiary in Germany. In any event, even if Merck (GUK) had been bound, under the Schweizerhall agreement, to use Natco as its exclusive supplier and the generic citalopram produced by the latter had infringed the crystallisation patent, it is possible that Natco could have produced the citalopram API using other non-infringing processes (recital 746 of the contested decision).

129    That adequately demonstrates that, far from being inevitable, the possibility of a legal action brought by Lundbeck formed part of the risks that a generic undertaking such as Merck (GUK), having made considerable investments and taken significant steps in order to enter the market, was ready to accept before the agreements at issue were concluded. Furthermore, the applicant has not established that such actions, if they had been brought, would have been decided, in every case, in Lundbeck’s favour and that they would have constituted an insurmountable barrier to its entering the citalopram market.

130    The evidence on which the applicant relies in attempting to call that conclusion into question shows, at most, that there was uncertainty as to whether Merck (GUK)’s generic products infringed Lundbeck’s patents, which the Commission does not dispute. Although Lundbeck initially threatened Merck (GUK) with infringement actions, it ultimately preferred to conclude the agreements at issue and to pay Merck (GUK) not to enter the market with its generic products during the term of those agreements. In accordance with the case-law cited in paragraph 86 above, that evidence confirms the existence of potential competition between Merck (GUK) and Lundbeck in the present case.

131    The present complaint must, therefore, be rejected.

b)     The impact of the Paroxetine judgment on Lundbeck’s opposition to the launch of generic citalopram and on the risk assessment carried out by Merck (GUK)

132    The applicant submits that, even if Merck (GUK)’s market entry would not have infringed Lundbeck’s crystallisation patent, such an at risk entry would not have constituted a viable option, as a result of the judgment of the High Court of Justice (England & Wales), Chancery Division, of 23 October 2001 in Smithkline Beecham Plc v Generics (UK) Ltd ([2002] 25(1) I.P.D. 25005, ‘the Paroxetine judgment’), which allowed Lundbeck to obtain interim measures prohibiting the sale of generic citalopram until the resolution of that litigation.

133    It maintains that the Paroxetine judgment fundamentally altered the legal context in which the generic undertakings operated. That judgment established a presumption that the courts will grant an injunction prohibiting the marketing of generic citalopram unless the generic undertaking has first taken steps to ‘clear the way’. The judgment marked a radical departure from the approach previously taken by the courts in the United Kingdom and was the first patent case for some time in which interim measures had been granted. The decision altered the situation and caused Merck (GUK) to review its strategy on the launch of citalopram in the United Kingdom. In that regard, according to the applicant, the Commission disregarded the fact that the specific purpose of the obligation to clear the way stemming from the Paroxetine judgment was to ensure that the issue of the grant of interim measures would not arise.

134    The applicant takes issue with the Commission for not having taken proper account of that judgment in the contested decision, which would have enabled it to establish that the grant of interim relief would have blocked market entry by Merck (GUK) for what would probably have been a longer period than the term of each of the agreements at issue. The Paroxetine judgment is mentioned only in two footnotes to the contested decision, but the Commission did not draw all the inferences and did not address the question whether, in the absence of the agreements at issue, the situation would have been more competitive. In the applicant’s submission, there is no evidence that Merck (GUK) would have launched its generic if it had not reached a sufficiently attractive agreement with Lundbeck and if there was a risk that it would face legal action.

135    The Commission disputes those arguments.

136    In that respect, 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 of 16 July 2014 in Zweckverband Tierkörperbeseitigung v Commission, T‑309/12, EU:T:2014:676, paragraph 222) in respect of which the General Court is required, in principle, to carry out a comprehensive review (paragraph 96 above).

137    In the case that gave rise to the Paroxetine judgment, Mr Justice Jacob of the High Court of Justice (England & Wales), Chancery Division applied the principles governing the grant of interim injunctions in English law and found that the balance of interests weighed in favour of the originator undertaking in view of the particular circumstances of the case, in particular the fact that GUK had not ‘cleared the way’ by informing the originator undertaking of its firm intention to launch its generic product on the market, even though it had been preparing for that entry for four years and despite the fact that it knew that the originator undertaking held patents allowing it to bring an infringement action against it.

138    Without it being necessary to rule on the interpretation and the exact scope of that judgment, it must be noted, as the Commission points out, that in the present case — unlike the facts of the case that gave rise to the Paroxetine judgment — Merck (GUK) had taken steps to inform Lundbeck of its firm intention to enter the market well before it intended to launch its generic products. The contested decision thus refers to the existence of a meeting between Lundbeck and Merck (GUK) as early as February 1999, from which it can already be seen that Lundbeck was aware of Merck (GUK)’s intention to develop and sell a generic version of citalopram, and that numerous contacts between Lundbeck and Merck (GUK) took place in the course of 2000 and 2001.

139    Moreover, contrary to the situation at issue in the case that gave rise to the Paroxetine judgment, in the present case, the crystallisation patent was published and granted within the meaning of Article 25 of the UK Patents Act 1977 only on 30 January 2002 in the United Kingdom, that is to say shortly after Merck (GUK) obtained an MA in the United Kingdom, on 9 January 2002, and well after it had begun taking steps to enter the citalopram market with a generic version of that product. Accordingly, it is erroneous to state, as the applicant does, that Lundbeck could have requested interim measures before that date and, under the principles set out in the Paroxetine judgment, it is at the very least doubtful that, if Merck (GUK) had entered the market at risk, Lundbeck would have been able to obtain interim measures after that date in the present case by relying on the crystallisation patent in order to block that entry.

140    As regards the applicant’s argument that the Commission did not take sufficient account of that judgment in the contested decision, it must be recalled that, first of all, the Commission is not obliged to adopt a position on all the arguments relied on by the parties concerned and it is sufficient if it sets out the facts and the legal considerations having decisive importance in the context of the decision (judgments of 1 July 2008 in Chronopost and La Poste v UFEX and Others, C‑341/06 P and C‑342/06 P, ECR, EU:C:2008:375, paragraph 96, and of 3 March 2010 in Freistaat Sachsen and Others v Commission, T‑102/07 and T‑120/07, ECR, EU:T:2010:62, paragraph 180).

141    Accordingly, in view of the differences between the applicant’s situation in the present case and that at issue in the case that gave rise to the Paroxetine judgment, the Commission was entitled to take the view that the Paroxetine case did not constitute an essential part of its analysis for the purpose of determining whether the applicant and Lundbeck were potential competitors at the time the agreements at issue were concluded. The various letters and communications invoked by the applicant in support of its arguments show only that, although Merck (GUK) was confident in its patent position, it was not certain that it would succeed in the event of litigation with Lundbeck and that it therefore preferred to conclude lucrative agreements with the latter, which the Commission does not dispute.

142    In any event, it must be pointed out that the Commission indeed took account of the Paroxetine judgment, in particular in footnote No 312 of the contested decision, where it found that it was difficult to see how that judgment could have made Lundbeck less inclined to litigate, if that judgment was indeed more favourable to patent holders. Likewise, as regards Merck (GUK), the Commission considered, in footnote No 1134 of the contested decision, that, despite that judgment, a producer of generics was still entitled to launch its product at risk without having to prove that its product did not infringe any patent. The burden of proof therefore rested, in that respect, even in the United Kingdom after the Paroxetine judgment, on the undertaking holding the patent, and the evidence adduced by the applicant does not call that conclusion into question.

143    It follows from the foregoing that the applicant’s complaint that the Commission did not take sufficient account of the implications of the Paroxetine judgment, and, in particular, of the impact of that judgment on Lundbeck’s opposition to the launch of generic citalopram and on the risk assessment carried out by Merck (GUK) in that respect must be rejected.

c)     The absence of other routes to the market which would have allowed Merck (GUK) to launch its generic on the market well before the expiry of the agreements at issue

144    The applicant disputes the eight possible routes to the market identified by the Commission in recital 635 to the contested decision and takes issue with the Commission for not having identified which of those eight possible routes would have been taken in the absence of the agreements at issue.

145    The Commission disputes those arguments.

146    It must be noted, as the applicant submits, that, in recital 635 of the contested decision, the Commission identified eight possible routes to the market which were in principle open to generic undertakings such as the applicant at the time the agreements at issue were concluded.

147    The first four of those potential routes consisted, first, in launching the generic product ‘at risk’ and facing possible infringement actions brought by Lundbeck, secondly, making efforts to ‘clear the way’ before entering the market, thirdly, requesting a declaration of non-infringement from a national court and, fourthly, claiming patent invalidity before the national courts, as a counter-claim in infringement proceedings.

148    Those four routes — which concern patent litigation with Lundbeck that would have considerably delayed the market entry of generics — would not, according to the applicant, have allowed the market entry of generic products before the term of the agreements at issue expired. Accordingly, in the applicant’s submission, the Commission should have evaluated the likely duration of that litigation in the contested decision.

149    It must be noted however that, as the Commission submits, that interpretation is not supported by the facts, as set out in, inter alia, paragraphs 74 to 80 above, which show that Merck (GUK) was ready to enter the United Kingdom market imminently, once Lundbeck’s original patents had expired, that is to say, in principle, in January 2002 and at the latest during the first quarter of 2002. Moreover, it must be borne in mind that Merck (GUK) had already obtained an MA for the United Kingdom on 9 January 2002 and that it was planning to obtain similar MAs in several other EEA States. It can also be seen from Lundbeck’s strategic plan of 2003, referred to in recital 206 of the contested decision, that Lundbeck itself had confirmed that ‘the expected entry of generic citalopram in [the first quarter of] 2002 [had been] very effectively postponed until October 2002’ and that ‘it remain[ed] obvious that the absence of generics for 10 months longer than expected in 2002 [would] continue to have a positive effect’.

150    In view of that evidence, the applicant cannot maintain that the market entry of citalopram would have been entirely impossible before the expiry of the agreements at issue, even in the absence of those agreements, as a result of legal actions that could have been brought by Lundbeck. In addition, as noted in paragraphs 116 to 129 above, it is far from certain that, if such actions had been brought by Lundbeck, they would have inevitably given rise to interim measures or would have made it impossible for the applicant to enter the market during the term of the agreements at issue.

151    In any event, as the Commission rightly submits, it was not required to establish that, in the absence of the agreements at issue, Merck (GUK) would undoubtedly have entered the market before those agreements expired, but only that it had real concrete possibilities of doing so, and that those possibilities were not purely theoretical but showed a real capacity to enter the market within a sufficiently short period to exert competitive pressure on Lundbeck (see, to that effect, judgment in Visa Europe and Visa International Service v Commission, cited in paragraph 82 above, EU:T:2011:181, paragraph 168).

152    It is true that the Commission cannot rely on purely theoretical possibilities, which are entirely unfeasible in practice, in order to establish the existence of potential competition. However, the Commission also cannot be required to show that those possibilities would undoubtedly have materialised, in the absence of the agreements at issue, nor to establish which of those possibilities was the most likely to occur. It is sufficient for the Commission to establish, on the basis of objective evidence, that real concrete possibilities of entering the market existed at the time the agreements at issue were concluded, as is the case here (paragraphs 74 to 80 above).

153    Accordingly, since at least two of the eight possible routes to the market identified by the Commission in recital 635 of the contested decision (paragraph 72 above), namely the launch at risk and the possibility of having Lundbeck’s patent declared invalid before the national courts, constituted real concrete possibilities for Merck (GUK) to enter the market, it does not assist the applicant to argue that the other routes identified in a general manner by the Commission in the same recital would not have allowed it to enter the market in the absence of the agreements at issue.

154    In any event, the fifth route identified in recital 635 of the contested decision (paragraph 72 above) concerns the possibility of requesting, before the competent national patent authorities or before the EPO, that Lundbeck’s crystallisation patent (or any other patent) be revoked or narrowed. The applicant submits, in that respect, that the precedent concerning Merck dura, a subsidiary of Merck in Germany, mentioned by the Commission in recital 166 of the contested decision, is not appropriate since the opposition procedure brought by Merck dura was not resolved before the expiry of the agreements at issue.

155    In that respect, it must be again be pointed out that the very fact that a similar action brought by Merck dura succeeded, even after the expiry of the agreements at issue, does not mean that market entry in the United Kingdom or the EEA was not a real concrete possibility for the applicant, but shows, on the contrary, that it exerted competitive pressure on Lundbeck in several EEA States.

156    Lastly, the last three routes identified in recital 635 of the contested decision (paragraph 72 above) concern the possibility of using another API based on a process that did not infringe Lundbeck’s patents or switching to another API producer. According to the applicant, those possibilities are wholly unrealistic, since, first, Merck (GUK) was bound by an exclusive supply agreement with Schweizerhall for a period of eight years; secondly, no non-infringing version of citalopram was available at the time; and, thirdly, even on the assumption that a change of process would have been possible, it would not have enabled generic citalopram to enter the market more quickly, as such a procedure can last between 14 and 25 months, or even longer.

157    The applicant cannot maintain, however, that those last three routes did not represent real concrete possibilities of entering the market.

158    First, even though Merck (GUK) was in principle required to cover its citalopram requirements with Natco under the supply contract concluded with Schweizerhall (paragraph 78 above), that agreement could probably have been terminated in the event of infringement and, if not, Natco could have altered its production method in order to circumvent Lundbeck’s patents by relying on non-infringing patents (paragraph 128 above).

159    Secondly, as the Commission submits, the assertion that there was no non-infringing version of generic citalopram is not supported by the facts. It must be borne in mind that any API producer could have used the original cyanation and alkylation processes as published with the patent on Lundbeck’s API, which had expired (paragraph 5 above). Thus, it can be seen from recital 158 of the contested decision that, in the context of the Lagap litigation, which concerned the generic citalopram in the form of API produced by Matrix, another Indian producer of generic citalopram, Lundbeck’s counsel acknowledged that Matrix ‘[did] the cyanation more efficiently than we [had] believed that they could do it’, which shows that it was possible to produce generic citalopram on an industrial scale using Lundbeck’s original patents.

160    In addition, Lundbeck itself confirmed that its new process patents were not capable of blocking all possibilities of entering the market, even though the crystallisation-based process seemed to be the most effective. Thus, by way of example, the Commission noted, in recital 163 of the contested decision, that Niche Generics Ltd had entered the market by obtaining a declaration of non-infringement for the generic citalopram supplied by another Indian API producer, Sekhsaria. It can also be seen from the evidence referred to in recital 634 of the contested decision that, in March 2002, Lundbeck’s patent experts declared that ‘it [was] possible to make an [API] that very probably [did] not require crystallisation of the free base’, i.e. which was not based on Lundbeck’s crystallisation patent. Lundbeck’s Vice-President also stated in a press release of 9 November 2002 that ‘it would be naive to think that it is not possible for producers of generic copies to produce Cipramil without breaking our patent’.

161    Thirdly, it is apparent from the statistics of the UK Medicines Control Agency referred to in recital 86 of the contested decision that a major variation of an MA, known as ‘type II’, 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 L 55, p. 7) — which is the procedure used when a generic undertaking which has already obtained an MA wishes to switch to another API supplier and therefore to another manufacturing process — normally took a maximum of 90 days from receipt of the application along with a complete dossier. A ‘type I’ variation, which is the procedure used in order to make minor changes to an existing MA without changing API supplier, took a maximum of 30 days (recital 86 of the contested decision). The periods of 14 to 25 months invoked by the applicant, mentioned by the Commission in recital 85 of the contested decision, are therefore not relevant, since they concern the total time required for the grant of an initial MA and not for the variation of an existing MA. 

162    Accordingly, that complaint must also be rejected.

d)     The complaint that the Commission ought to have examined the competitive situation in each EEA Member State in order to be able to conclude that there was potential competition throughout the EEA.

163    The applicant argues that the product markets for the supply of pharmaceutical products such as citalopram are national in scope and that the Commission ought therefore to have ascertained whether Merck (GUK) and Lundbeck were potential competitors in each Member State of the EEA in which it found an infringement, instead of making a single assessment for the whole of the EEA. It submits that, at the time the EEA agreement was concluded, Merck (GUK) had not obtained an MA in Greece, Spain, Italy, the Netherlands, Iceland or Lichtenstein, and that it had not obtained price approval and inclusion on the list of reimbursed medicines in France. Moreover, after the expiry of the EEA agreement, Merck (GUK) was still not able to market its generic in a number of States, including Denmark, Luxembourg, Portugal and Norway, for reasons entirely unrelated to the EEA agreement.

164    It must be found, however, that, contrary to the applicant’s assertions, in order to conclude that there was potential competition between Merck (GUK) and Lundbeck in the entire EEA, the Commission was in no way required to establish that Merck (GUK) actually entered the citalopram market in all the Member States of the EEA during the term of the agreements at issue, nor that it had already obtained an MA in all those States, but only that it had real concrete possibilities of doing so — without those possibilities being purely theoretical — which showed a real ability to enter the market within a sufficiently short period to exert competitive pressure on Lundbeck (see, to that effect, judgment in Visa Europe and Visa International Service v Commission, cited in paragraph 82 above, EU:T:2011:181, paragraph 168).

165    The analysis carried out by the Commission in recitals 827 to 840 of the contested decision (paragraphs 78 to 80 above) and the evidence on which the Commission relied in that respect show that Merck (GUK) and Lundbeck were potential competitors throughout the EEA at the time the EEA agreement was concluded. The fact that, in some States, obtaining an MA could have taken more time or that the generic product was not included in the list of reimbursed medicinal products does not alter that conclusion.

166    It must also be pointed out that Merck (GUK) actually entered the United Kingdom market in August 2003 as well as the Swedish market, through NM Pharma, from May to October 2002. That demonstrates not only that Merck (GUK) was an actual competitor of Lundbeck in the United Kingdom and in Sweden, but also that it was a potential competitor of Lundbeck throughout the EEA, because of the use of the mutual recognition procedure laid down in Directive 2001/83, at the time the agreements at issue were concluded (paragraph 79 above).

167    Furthermore, the very fact that the EEA agreement covered the whole EEA territory (with the exception of the United Kingdom) demonstrates that Lundbeck perceived Merck (GUK) as a potential threat in the whole of that territory and that the latter had real concrete possibilities of entering the EEA markets at the time the agreements at issue were concluded.

168    In addition, it can be seen from the contested decision that the Commission took into account the differences between the EEA Member States when those differences were relevant for the purpose of examining the existence of potential competition in that territory. Thus, the Commission mentioned, in recital 827 of the contested decision, that Lundbeck’s API patent expired only in April 2003 in Austria, unlike in the other Member States. It also examined the situation as regards the MAs in various EEA States in recitals 326, 347 and 827 to 830 of the contested decision.

169    The Commission therefore did not err in concluding, in the contested decision, that Lundbeck and Merck (GUK) were potential competitors at the time the agreements at issue were concluded.

3.     The existence of actual competition between Lundbeck and Merck (GUK) at the material time

170    As regards the complaint that the Commission wrongly concluded that there was actual competition between Lundbeck and Merck (GUK) during the relevant period, it must be pointed out at the outset that that complaint is ineffective and, in any event, unfounded.

171    Even if that complaint were well founded, it would not be capable of calling into question the conclusion that Merck (GUK) and Lundbeck were potential competitors at the time the agreements at issue were concluded. The Commission was in no way required to establish that Merck (GUK) and Lundbeck were actually competitors at the time the agreements at issue were concluded. It only relied on the two examples concerning the United Kingdom market and the Swedish market in order to demonstrate that Merck (GUK) and Lundbeck were at the very least potential competitors at the time the agreements at issue were concluded.

172    In any event, it must be emphasised, as the Commission submits, that the applicant does not dispute that it actually entered the United Kingdom market from 1 to 4 August 2003, that is to say, immediately after the first extension of the UK agreement expired, on 31 July 2003. Nor does it dispute that NM Pharma actually entered the Swedish market for five months, from 21 May to 22 October 2002, before the EEA agreement was concluded.

173    It follows from those factual elements, which have not been contested by the applicant, that Merck (GUK) was an actual competitor of Lundbeck in the United Kingdom from 1 to 4 August 2003 and in Sweden from May to October 2002, through its distributor NM Pharma. In that respect, even though NM Pharma was a different undertaking, as the applicant points out, it was Merck (GUK)’s exclusive distributor in Sweden and it is apparent from Merck (GUK)’s internal emails, referred to in recitals 314 and 319 of the contested decision, that it is with Merck (GUK) and not with NM Pharma that Lundbeck negotiated the EEA agreement, by which Merck (GUK) undertook, inter alia, to no longer supply generic citalopram to NM Pharma in Sweden. In this way, Lundbeck was able successfully to obtain the withdrawal of generics from the Swedish market and, therefore, from a substantial part of the EEA (paragraph 79 above).

174    The applicant nevertheless submits that such market entry was ‘at risk’ and unlawful, with the result that it cannot be regarded as the legitimate exercise of actual or potential competition.

175    That line of argument cannot succeed.

176    The case-law cited in paragraphs 81 to 87 above requires only that it be shown that Merck (GUK) had real concrete possibilities of entering the market, which is certainly the case where a generic undertaking is able to enter the market, even at its own risk.

177    Accordingly, the applicant cannot argue that such real concrete possibilities did not exist in the present case, when it sold tablets amounting to GBP 3.3 million in the United Kingdom in August 2003 and NM Pharma, Merck (GUK)’s distributor in Sweden, had — for almost five months — made ‘very encouraging’ sales (recital 837 of the contested decision) on the Swedish market, before the conclusion of the EEA agreement, without worrying about Lundbeck (paragraph 127 below).

178    In addition, the applicant’s argument is based on the erroneous premiss that, first, its generic products undoubtedly infringed Lundbeck’s patents and, secondly, those patents would certainly have withstood the claims of invalidity that would have been raised by it in infringement actions.

179    Whilst patents are indeed presumed valid until they are expressly revoked or invalidated by a competent authority or court, that presumption of validity cannot be equated with a presumption of illegality of generic products validly placed on the market which the patent holder deems to be infringing the patent.

180    It must be recalled in that respect, and the parties do not dispute, that the possibility for a generic undertaking to sell its generic products on the market, which arises as a result of the granting of an MA, does not depend upon that undertaking demonstrating that those products are not infringing (recital 624 of the contested decision).

181    The applicant therefore errs in its argument that an at risk market entry could not suffice to establish the existence of a situation of, at the very least, potential competition between it and Lundbeck. It is also to no avail that the applicant submits that Merck (GUK) and Lundbeck were not actual competitors during a certain period in Sweden and in the United Kingdom, since the Commission did not need to demonstrate this in order to establish the existence of potential competition between them.

182    Accordingly, all of the applicant’s arguments raised in the context of the fourth and sixth pleas in law, in so far as they are intended to call into question the Commission’s conclusion that there was potential competition between Merck (GUK) and Lundbeck at the time the agreements at issue were concluded, must be rejected.

III –  The first, second, fourth, fifth, seventh and eighth pleas in law, alleging, in essence, infringement of Article 101(1) TFEU

183    By all of those pleas in law, the applicant calls into question the Commission’s interpretation of Article 101(1) TFEU (first plea in law) and the theory of harm on which it relied in that respect in concluding that the agreements at issue constituted a restriction of competition by object for the purpose of that provision (second plea in law). It also submits that the Commission did not take adequate account of the factual, economic and legal context, which shows that, absent the agreements at issue, Merck (GUK) would not have entered the United Kingdom market and the other EEA markets any more quickly (fourth plea in law). The applicant argues, moreover, that the Commission committed an error of assessment in examining the scope of the agreements at issue (fifth plea in law), in finding that the applicant had an anticompetitive intention in concluding the agreements at issue (seventh plea in law), and in its conclusions relating to the size and purpose of the value transfer made under those agreements (eighth plea in law).

184    Before examining the applicant’s various arguments, it is appropriate to summarise briefly the relevant case-law and the approach taken by the Commission in the contested decision in finding that the agreements at issue in the present case constituted a restriction of competition ‘by object’, and to examine the more general arguments put forward by the applicant in that respect.

A –  Applicable principles and case-law

185    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.’

186    In that regard, it is apparent 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 40 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. 359 and 360; and 14 March 2013 in Allianz Hungária Biztosító and Others, C‑32/11, ECR, EU:C:2013:160, paragraph 34).

187    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 40 above, EU:C:2014:2204, paragraph 50; see also, to that effect, judgment in Allianz Hungária Biztosító and Others, cited in paragraph 186 above, EU:C:2013:160, paragraph 35 and the case-law cited).

188    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 (see judgment in CB v Commission, cited in paragraph 40 above, EU:C:2014:2204, paragraph 51 and the case-law cited; 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).

189    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 186 above, EU:C:2013:160, paragraph 34, and CB v Commission, cited in paragraph 40 above, EU:C:2014:2204, paragraph 52).

190    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 186 above, EU:C:2013:160, paragraph 36 and in CB v Commission, cited in paragraph 40 above, EU:C:2014:2204, paragraph 53).

191    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 186 above, EU:C:2013:160, paragraph 37, and CB v Commission, cited in paragraph 40 above, EU:C:2014:2204, paragraph 54).

192    It must be examined, in the light of those principles, whether the Commission was entitled to characterise the agreements at issue as a restriction by object for the purpose of Article 101(1) TFEU, in view of the content, the purpose and the context of those agreements.

B –  Analysis relating to the existence of a restriction of competition by object in the contested decision

193    The Commission considered, in the contested decision, that the agreements at issue 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 (paragraph 31 above).

194    It considered, therefore, that the fact that Lundbeck’s original patents had expired before the conclusion of the agreements at issue, but that it had obtained — or was about to obtain — several process patents at the time those agreements were concluded, including the crystallisation patent, was a significant element of the economic and legal context in which the agreements at issue were concluded. The Commission took the view, however, that a patent did not grant the right to limit the commercial autonomy of parties by going beyond the rights granted by that patent (recital 638 of the contested decision).

195    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 payments’) (recitals 639 and 640 of the contested decision).

196    It can also be seen from the contested decision that, even if the restrictions set out in the agreements at issue fell within the scope of the Lundbeck patents — that is to say that the agreements prevented only the market entry of generic citalopram deemed to potentially infringe those patents by the parties to the agreements and not that of 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).

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

198    It must be noted, in that respect, that the Commission did not find, in the contested decision, that all patent settlement agreements containing reverse payments were contrary to Article 101(1) TFEU; it found 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 at issue, 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).

199    The applicant’s various pleas in law must be assessed in the light of those considerations.

C –  The first plea in law, alleging that the Commission erred in its interpretation of the concept of a restriction by object within the meaning of Article 101 TFEU

200    The applicant recalls, first of all, the relevant legal principles for determining a restriction by object for the purpose of Article 101(1) TFEU. Thus, it is necessary to examine whether the actual object of the agreement, having regard to the economic and legal context in which it must be applied, is sufficiently harmful for competition. Such a presumption of a harmful effect on competition applies only if it is based on the serious nature of the restriction and on experience showing that such restrictions are likely to produce negative effects on the market. The concept of restriction by object must therefore be interpreted strictly and be limited to cases in which a particularly serious inherent capacity for negative effects can be identified.

201    In the applicant’s submission, the approach adopted by the Commission in recital 652 of the contested decision inter alia is erroneous, since it relied on a formulation, not recognised in the case-law, according to which the decisive criterion for establishing a restriction by object is whether an agreement has the objective of restricting competition. The Commission also departed from its own approach on that issue, as defined in the guidelines on the application of Article [101(3) TFEU] (OJ 2004 C 101, p. 97), and applied a lower threshold than that set out in those guidelines.

202    Thus, the applicant claims that the judgment of 13 October 2011 in Pierre Fabre Dermo-Cosmétique (C‑439/09, ECR, EU:C:2011:649), which the Commission cites in support of its approach, must be distinguished from the present case, since, in the case that gave rise to that judgment, the Commission had already made clear in its Guidelines that restrictions of the type concerned, consisting in a ban on passive internet sales, constituted a restriction by object.

203    Likewise, the relevance of the judgment of 29 November 2012 in CB v Commission (T‑491/07, EU:T:2012:633), on which the Commission relies in the contested decision, is called into question by the applicant, in so far as that judgment states explicitly that the restrictive effects of a particular practice must be clear, without the need for a full analysis of its effects, before that practice can be characterised as a restriction by object within the meaning of Article 101 TFEU. 

204    In response to a question put to it by the Court concerning the inferences to be drawn from the judgment in CB v Commission, cited in paragraph 40 above (EU:C:2014:2204), the applicant submitted that that judgment confirmed its interpretation that the concept of restriction of competition by object should be applied strictly and be reserved only for cases in which there is no doubt as to the harmful nature of the agreement or practice concerned on competition. In this case, according to the applicant, there is no such certainty, since if the agreements at issue had not been signed it is not certain that the generic undertakings would have been able to enter the market, because of the process patents held by Lundbeck. Thus, unlike the other cases in which a restriction by object could be established, in the present case there are no clearly identifiable harmful effects on competition.

205    Therefore, in the applicant’s submission, although a patent settlement providing for reverse payments may, in theory, restrict competition, in circumstances which it is by definition impossible to verify, the Commission cannot characterise agreements making provision for such payments as restrictions of competition by object.

206    The Commission disputes those arguments.

207    It must be pointed out, first of all, that it can be seen from the case-law cited above, in particular the judgment in CB v Commission, cited in paragraph 40 above (EU:C:2014:2204), that, by that judgment, the Court of Justice did not call into question the basic principles concerning the concept of a restriction by object set out in the previous case-law.

208    It is true that, in its judgment in CB v Commission, cited in paragraph 40 above (EU:C:2014:2204, paragraph 58), the Court of Justice rejected the General Court’s analysis in the judgment in CB v Commission, cited in paragraph 203 above (EU:T:2012:633), according to which the concept of restriction of competition by object should not be interpreted in a restrictive manner. 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 (paragraph 186 above).

209    However, the applicant’s argument that the Commission should have examined the effects of the agreements at issue is not correct, since, although the Commission established to the requisite legal standard that those agreements could be regarded — given their content, the scope of their provisions and their objectives, viewed in their economic and legal context — as sufficiently harmful to competition, it was not required, in addition, to examine the specific effects of those agreements on competition in order to establish the existence of a restriction of competition by object, for the purpose of Article 101(1) TFEU (paragraphs 186 to 190 above).

210    It can be seen from the general scheme of the contested decision, in particular recitals 802, 821, 871, 1300, 1331, 1332, 1338, 1361 and 1362, that the Commission considered that the agreements at issue were akin to market exclusion agreements, which are among the most serious restrictions of competition and which were therefore, by their very nature, harmful to the normal operation of competition. In doing so, the Commission correctly applied the case-law cited in paragraphs 186 to 191 above.

211    The Commission also recalled the wording of its Guidelines on the application of Article [101(3) TFEU] (paragraph 201 above) in recital 656 of the contested decision, and extracts from its Guidelines on the applicability of Article 101 TFEU to horizontal co-operation agreements (paragraph 60 above) in recitals 654 and 655 of the contested decision for the purpose of interpreting the concept of restriction of competition by object, and the applicant has not shown how the Commission committed a manifest error of assessment in that respect. It can be seen from those two instruments that agreements which are intended to share markets and consumers constitute restrictions of competition by object and that one of the ultimate aims of Article 101 TFEU is to protect the competitive process.

212    Moreover, contrary to what is claimed by the applicant, it is not necessary that the same type of agreements have already been censured by the Commission in order for the agreement in question to constitute 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 40 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 40 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).

213    In addition, it must be borne in mind that the concept of restriction of competition by object does not give rise to an irrebuttable presumption, since it follows from the case-law that Article 101(3) TFEU is intended also to apply to such restrictions (see, to that effect, judgments in Pierre Fabre Dermo-Cosmétique, cited in paragraph 202 above, EU:C:2011:649, paragraph 59, and of 15 July 1994 in Matra Hachette v Commission, T‑17/93, ECR, EU:T:1994:89, paragraph 85).

214    It follows from the foregoing that the applicant cannot succeed in its submission that the Commission did not apply the appropriate legal test in the present case.

215    It must nevertheless be verified whether, on the basis of the evidence available to it at the time it adopted the contested decision, the Commission was entitled to conclude that it followed from the content of the agreements at issue, their objectives and their economic and legal context, that they could be regarded as being particularly harmful to competition and therefore characterised as a restriction by object for the purpose of Article 101(1) TFEU.

D –  The second plea in law, alleging that the theory of harm applied by the Commission is fundamentally flawed

216    By its second plea, the applicant claims that the theory of harm applied by the Commission in the contested decision is fundamentally flawed. This plea is divided into four parts.

1.     The first part, alleging that the Commission erred in law failing to have proper regard to Lundbeck’s ownership of the crystallisation patent

217    The applicant observes, first of all, that a patent confers an exclusive right to commercialisation of the invention to the patent holder, in order to ensure sufficient compensation to the inventor and in order to preserve incentives for research and development in general and to stimulate innovation. The Court of Justice confirmed in its judgment of 31 October 1974 in Centrafarm and De Peijper (15/74, ECR, EU:C:1974:114) that, in relation to patents, the specific subject matter of the industrial property is the guarantee 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.

218    Thus, in the applicant’s submission, the idea that valid intellectual property rights must be capable of being fully exploited and protected to reward innovation is reflected in the doctrine of the presumptive validity of patents, which states that, once granted, patents are presumed to be valid. That presumptive validity is specifically recognised in EU law and in particular by the judgment of 1 July 2010 in AstraZeneca v Commission (ECR, EU:T:2010:266, paragraph 362). It follows that a patent settlement agreement which delays generic entry to the market, within the scope of a validly granted patent, does not restrict competition, since, in the absence of any settlement of that type, the presumptively valid patent already prohibits the market entry of that generic.

219    The applicant submits that, in the present case, Lundbeck was the holder of a crystallisation patent that the generic citalopram infringed. That patent has not been the subject of any court decision in the EEA and has therefore not been declared invalid by any national court. Nor did the Commission undertake any assessment of the validity of the crystallisation patent in the contested decision, with the consequence that Lundbeck was the holder of a presumptively valid patent at the time of conclusion of the agreements at issue, which entitled it to oppose the entry to the market of generic medicinal products, which means that the agreements at issue did not entail barriers to competition other than those that could have been obtained legally in the absence of these agreements.

220    In the applicant’s submission, the Commission’s ‘ex ante’ approach in the contested decision has the absurd result that a patent settlement agreement which merely limited the market entry of a generic which would have unlawfully infringed a valid patent nonetheless constituted a restriction by object solely because the outcome of patent validity proceedings could not have been predicted with total accuracy at the time when the agreement was concluded. Such an analysis is, according to the applicant, fundamentally flawed. A restriction of competition can be established only where an agreement leads to a less competitive market than would have existed in the absence of the agreement, and the mere fact that litigation between undertakings was avoided is wholly irrelevant as regards competition law.

221    The applicant therefore maintains that the Commission ought to have undertaken its own assessment of the validity of the patent in the contested decision in order to be able to find an infringement of Article 101(1) TFEU. Thus, first, the Commission’s approach renders meaningless the presumptive validity of patents and inflicts serious damage on the public policy objectives underlying the patent system. While an analogy may be drawn between the patent system abuses found in the case that gave rise to the judgment in AstraZeneca v Commission, cited in paragraph 218 above (EU:T:2010:266), and a settlement agreement concluded when the patent that is the subject of the dispute was obtained fraudulently or dishonestly, the same does not apply where the patent has been validly and lawfully granted. Secondly, according to the applicant, the Commission’s approach is directly contrary to the public interest in promoting the settlement of disputes, which are a legitimate way of ending private disagreements, since, in maintaining that legal actions against the process patents are an expression of potential competition on the part of generic undertakings, it leaves no room for the settlement of patent disputes.

222    Therefore, in the applicant’s submission, the Commission ought rather to have made an ex post assessment of the agreements at issue, based on all the relevant information available to it at the time of its assessment, including by reference to the relevant legal context. The question whether an agreement restricts competition is an objective question which concerns effects in the market and not a subjective question concerned with the parties’ intentions when they entered into the agreement.

223    The Commission disputes those arguments.

224    As regards, first of all, the judgment in Centrafarm and de Peijper, cited in paragraph 217 above (EU:C:1974:114), referred to by the applicant, it must be pointed out that, as the Commission submits, that judgment in no way excludes the application of Article 101(1) TFEU to settlement agreements in relation to patents, but provides, on the contrary, that, although the existence of rights recognised under the industrial property legislation of a Member State is not affected by the provisions of that article, the conditions under which those rights may be exercised may nevertheless 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, cited in paragraph 217 above, EU:C:1974:114, paragraphs 39 and 40).

225    Likewise, according to the case-law, 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 TFEU and 102 TFEU (judgment of 25 February 1986 in Windsurfing International v Commission, 193/83, ECR, ‘the Windsurfing judgment’, EU:C:1986:75, paragraph 26). The Court of Justice has also held that the specific subject matter of the patent cannot be interpreted as also affording protection against actions brought in order to challenge the patent’s validity, in view of the fact that it is in the public interest to eliminate any obstacle to economic activity which may arise where a patent was granted in error (the Windsurfing judgment, EU:C:1986:75, paragraph 92).

226    Accordingly, while it is true 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 in Centrafarm and de Peijper, cited in paragraph 217 above, EU:C:1974:114, paragraph 9), the existence of a patent does not entail the right to exclude temporarily or definitively an actual or potential competitor from the market, under the guise of settling certain disputes, where the outcome of those disputes is highly uncertain and it can be seen both from the content of the agreements in question and from the context in which they were concluded that the purpose of those agreements is to restrict competition.

227    Contrary to the applicant’s assertion, that does not call into question the presumption of validity enjoyed by patents; that presumption of validity cannot amount to a presumption of unlawfulness of all generic products validly placed on the market which are deemed to be infringing by a patent holder. As the Commission submits, 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 an at risk entry is not in itself unlawful. Moreover, in the context of an infringement action brought by Lundbeck against the generic producers, those producers 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. Thus, 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%.

228    According to the case-law, the very fact that a real concrete possibility of entering the market may be eliminated through an agreement between competitors suffices, in principle, to render that agreement contrary to Article 101(1) TFEU.

229    In addition, the Commission was not required to carry out its own assessment of the validity of Lundbeck’s crystallisation patent in an analysis based on the concept of restriction by object, in the absence of a final judgment on the existence of an infringement and on the validity of Lundbeck’s patents before the national courts (recitals 185 and 671 of the contested decision).

230    Although some proceedings were brought before the national courts, including the Lagap litigation in the United Kingdom which led to a settlement, none led to a final judgment resolving the issue of the validity of Lundbeck’s crystallisation patent or whether the generic products of Natco sold by Merck (GUK) were infringing (recital 159 of the contested decision).

231    The approach adopted by the Commission in the contested decision, which consists in taking account of the existence of Lundbeck’s process patents, and of examining the perception, by the parties to the agreements at issue, of Lundbeck’s patents and, in particular, of the crystallisation patent, at the time those agreements were concluded (recital 669 of the contested decision), is consistent with the Windsurfing judgment, cited in paragraph 225 above (EU:C:1986:75, paragraph 26), in which the Court of Justice held that it was not for the Commission to determine the scope of a patent, but that it could not refrain from all action when the scope of the patent is relevant for the purposes of determining whether there has been an infringement of Article 101 TFEU and 102 TFEU.

232    It can be seen from the evidence set out, inter alia, in recital 838 of the contested decision that Merck (GUK) was particularly confident that the Natco citalopram did not infringe Lundbeck’s crystallisation patent and that, at the time the agreements at issue were concluded, Merck (GUK) intended to launch its product in the United Kingdom and in several EEA States in the near future. Furthermore, it can be seen from the evidence set out in recital 754 of the contested decision that Merck (GUK), like other generic undertakings, had doubts as to the validity of the crystallisation patent and considered that its chances of succeeding in the event of litigation with Lundbeck were high.

233    Those factors confirm that the Commission indeed took account of the existence of Lundbeck’s crystallisation patent as one of the contextual elements that allowed it to establish the existence of a restriction by object in the present case (recital 661 and 662 of the contested decision).

234    Lastly, it must be borne in mind that the contested decision does not censure all settlement agreements in relation to patents, only those which, as in the present case, are akin to market exclusion agreements, due to the presence of a series of factors (paragraphs 31 and 198 above).

235    The applicant’s complaint must therefore be rejected.

2.     The second part, alleging that the Commission erred in law in treating settlement agreements in relation to patents as equivalent to market exclusion agreements

236    The applicant submits that the Commission committed an error of law in treating the agreements in the present case, which were patent settlement agreements, in the same way as market exclusion agreements such as those at issue in the case that gave rise to the BIDS judgment, cited in paragraph 188 above (EU:C:2008:643), or in the case that gave rise to the judgment of 16 June 2011 in Gosselin Group v Commission (T‑208/08 and T‑209/08, ECR, EU:T:2011:287). The two cases are fundamentally different, since in the present case Lundbeck had a legitimate right to oppose infringements of its patent.

237    In reality, according to the applicant, the agreements at issue did not restrict competition by comparison with the situation that would have existed in the absence of the agreements at issue (‘the counterfactual scenario’) and it is meaningless to find that the payments provided for in those agreements induced Merck (GUK) not to launch its medicinal products if the market entry of the generic medicinal products could not have taken place more quickly in the absence of the agreements at issue. Those agreements were concluded because of Lundbeck’s unrelentingly aggressive campaign of threatening Merck (GUK) with infringement proceedings in the United Kingdom and throughout the EEA. 

238    The Commission disputes those arguments.

239    It must be noted, first of all, that the Commission referred to the BIDS judgment, cited in paragraph 188 above (EU:C:2008:643), and the judgment in Gosselin Group v Commission, cited in paragraph 236 above (EU:T:2011:287), in recitals 657 and 658 of the contested decision in order to highlight certain similarities between the cases that gave rise to those judgment and the agreements at issue.

240    Thus, in the case that gave rise to the judgment in BIDS, cited in paragraph 188 above (EU:C:2008:643), the undertakings present on the market had paid some of their competitors to withdraw from the market, in order to improve their situation by maintaining artificially high prices, to the detriment of consumers.

241    Likewise, in the case that gave rise to the judgment in Gosselin Group v Commission, cited in paragraph 236 above (EU:T:2011:287), the competing removal undertakings agreed not to compete, in order to maintain higher price levels, again to the detriment of consumers.

242    The Commission acknowledged, however, that the main difference between those cases and the agreements at issue, by which potential competitors agreed to prevent generics from entering the market, resulted from the fact that those agreements had been concluded against the background of patent settlements and uncertainty regarding the outcome of potential litigation concerning those patents.

243    In doing so, the Commission did not commit an error of law.

244    As in the case that gave rise to the BIDS judgment, cited in paragraph 188 above (EU:C:2008:643), the agreements at issue 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 188 above, EU:C:2008:643, paragraphs 33 to 35).

245    It is true that, unlike the circumstances in the case that gave rise to the BIDS judgment, cited in paragraph 188 above (EU:C:2008:643), the agreements at issue were concluded in a context in which Lundbeck possessed patents allowing it to prevent the market entry of infringing products. It must be recalled, nevertheless, that, in the present case, the existence of new Lundbeck process patents did not preclude the generic undertakings from being considered potential competitors of Lundbeck, as can be seen from the assessment of the fourth and sixth pleas in law. Article 101 TFEU protects potential competition as well as actual competition (paragraph 82 above).

246    Furthermore, in paragraphs 84 and 85 of the judgment in CB v Commission, cited in paragraph 40 above (EU:C:2014:2204), the Court of Justice essentially highlighted the fact that the agreements referred to in the case that gave rise to the BIDS judgment, cited in paragraph 188 above (EU:C:2008:643), modified the structure of the market and presented a degree of harm such that they could be regarded as a restriction by object, whereas that was not the case as regards the conduct at issue in the case that gave rise to the judgment in CB v Commission, cited in paragraph 40 above (EU:C:2014:2204), which consisted in the obligation imposed on banks to pay a fee or to limit their bank card issuing activities.

247    In that respect, even if paragraphs 84 and 85 of the judgment in CB v Commission, cited in paragraph 40 above (EU:C:2014:2204), could be read as meaning that alteration of the structure of the market is a condition sina qua non for finding a restriction by object, the agreements at issue affected the structure of the markets concerned in the present case, since they delayed the applicant’s market entry, thus allowing Lundbeck to maintain high prices for Cipramil and to ensure more favourable conditions for the launch of Cipralex, which was supposed to replace Cipramil shortly (paragraph 9 above and recitals 129 to 132 of the contested decision).

248    In addition, 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). Furthermore, it may be regarded as having a restrictive object even if it does not have the restriction of competition as its sole aim but pursues other legitimate objectives (see the BIDS judgment, cited in paragraph 188 above, EU:C:2008:643, paragraph 21 and the case-law cited).

249    Contrary to the applicant’s assertion, it is sufficiently clear from the documents in the file and in particular from the minutes of the meeting of 11 December 2001 mentioned in recital 255 of the contested decision that the agreements at issue induced Merck (GUK) not to enter the market with its generic products during the term of those agreements by means of a considerable reverse payment. In so doing, as the Commission found in recitals 644 to 646 of the contested decision, Lundbeck and Merck (GUK) were able to share some of the profits that Lundbeck continued to make through sales of Cipramil, to the detriment of consumers which continued to pay higher prices than they would have paid if generics had entered the market.

250    It is true that it was not certain, at the time the agreements at issue were concluded, that Merck (GUK) would have entered the market immediately without having to confront Lundbeck in any infringement actions. However, as pointed out in paragraph 227 above, the outcome of such actions was highly uncertain and it is precisely the transformation of that uncertainty, which existed at the time of the agreements at issue were concluded, into the certainty that Merck (GUK) would not enter the market with its generic products during the term of those agreements by means of considerable reverse payments which constitutes a restriction of competition by object in the present case.

251    In the light of those considerations, that complaint must be rejected.

3.     The third part, alleging that the Commission erred in law in failing to conduct an assessment of the actual effects of the patent settlement agreements

252    By this part, the applicant again submits that even if the crystallisation patent would not ultimately have been held by a court either to be valid or to have been infringed, the agreements would not have had a restrictive effect on the relevant markets if they had not delayed the marketing of Merck (GUK)’s generic citalopram, since such marketing would not have been quicker in the absence of the agreements at issue. Thus, in order to find an infringement of Article 101 TFEU, the Commission ought first of all to have identified what the situation would have been in the absence of the agreements at issue and then to have examined whether those agreements produced a more or less restrictive effect than the counterfactual scenario. However, in the contested decision the Commission merely presumed that the agreements had an inherent risk of causing particularly harmful effects for competition and characterised the agreements as a restriction by object, without considering whether, on the facts, the agreements had more or less restrictive effects than the counterfactual scenario.

253    In addition, this is the first time that the Commission has analysed patent settlement agreements and it could not therefore rely on existing experience to show that those settlement agreements by their very nature have serious anticompetitive effects. The Commission ought to have taken a similar approach to that taken in Mastercard (decision of 19 December 2007, COMP 34.579, OJ 2009 C‑264, p. 8), where it had considered that, given that it was clearly established that Mastercard’s interchange fees had had the effect of restricting and distorting competition to the detriment of merchants, it was not necessary to reach a definitive conclusion as to whether those fees were a restriction by object.

254    The applicant also submits that the Commission altered its stance during the procedure, since it initially considered that those settlement agreements did not infringe Article 101(1) TFEU, as is clear from the KFST’s 2004 press release, which states that:

‘The Commission finds that this is a grey zone, and it has not been clarified how close we are to the “black zone” in the present case. ... It is the Commission’s opinion that the amounts in the Lundbeck case are of such size that it is not possible immediately to render probable that they constitute compensation for keeping a competitor out of the market. It is therefore doubtful whether the agreements are anticompetitive. Consequently, the Commission does not wish to initiate proceedings against Lundbeck. However, the Commission will at the beginning of 2004 initiate a general analysis of this type of cases to result in the establishment of a general standard determining how the cases are to be considered.’

255    The applicant therefore maintains that an assessment based on the effects of the agreement, rather than on their object, was necessary in the present case. First, such an assessment would also have been compatible with the way in which such agreements are dealt with in the law of the United States of America. In the judgment of 17 June 2013 in Federal Trade Commission v. Actavis (570 U.S. (2013), ‘the Actavis judgment’), the Supreme Court of the United States refused to apply the approach based on a ‘quick look’, which is similar to the concept of restriction by object for the purpose of Article 101(1) TFEU, and considered that it was appropriate to apply the rule of reason to such agreements, which means that the administration is required to demonstrate that its arguments are well founded.

256    Secondly, such an approach would have been compatible with the examination, under Article 101(1) TFEU, of the non-challenge clauses in the settlement agreements. The applicant claims that GUK did not give an undertaking in the agreements at issue not to challenge Lundbeck’s patents. Those agreements do not set any limit to GUK’s ability to challenge Lundbeck’s patents. Therefore, the reference in the contested decision to the Windsurfing judgment, cited in paragraph 225 above (EU:C:1986:75), where the Court of Justice considered that a non-challenge clause in a licence agreement was unlawful on the basis that it eliminated the possibility that legal actions could be brought against the licensed patents, is inappropriate. In the judgment in Bayer and Maschinenfabrik Hennecke (EU:C:1988:448), the Court of Justice also considered that non-challenge clauses in settlement agreements could not be assumed to have anticompetitive effects. Consequently, the Commission cannot justify the decision to characterise the agreements at issue as an infringement by object by the fact that they preclude any legal action, since strictly identical considerations did not prevent it from concluding that non-challenge clauses did not fall within the scope of Article 101(1) TFEU. 

257    The Commission disputes those arguments.

258    It must be recalled, first of all, that, pursuant to the case-law cited in paragraph 188 above, the Commission is not required to examine the specific effects of an agreement on the market when the very object of that agreement is to restrict competition, that it to say where it is sufficiently clear from the agreement itself, having regard to its context, that it is of a nature particularly harmful to competition and is likely to have negative effects on competition.

259    The applicant nevertheless submits that the Commission could not apply the concept of restriction by object in the present case, since this was the first time that it analysed settlement agreements between a patent holder and generic undertakings.

260    It must be borne in mind, in that respect, that it is established that certain collusive behaviour 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) EC, 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 (see, to that effect, judgment in CB v Commission, cited in paragraph 40 above, EU:C:2014:2204, paragraph 51).

261    That is the case here, since, by the agreements at issue, Lundbeck and Merck (GUK) agreed not to compete on the citalopram market during a certain period, to the detriment of consumers which could have benefited from generic medicinal products at a much lower price if those medicinal products had entered the market (paragraph 249 above). The fact that Lundbeck held certain process patents does not change that analysis, since, in view of the circumstances of the present case, where Merck (GUK) was a potential competitor of Lundbeck, those patents did not prevent the at risk market entry of Merck (GUK) and there were serious doubts concerning the outcome of the potential litigation in relation to the validity of those patents or the infringing nature of the generics (paragraph 227 above).

262    Furthermore, the fact that in the past the Commission did not take the view that a certain kind of agreement was, by its very object, restrictive of competition cannot, in itself, prevent it from doing so in the future following an individual, detailed examination of the measures at issue in the light of their content, purpose and context (paragraph 212 above).

263    As regards the reference made by the applicant to the Mastercard case (paragraph 253 above), it should be recalled that, according to settled case-law, the Commission’s practice in previous decisions cannot itself serve as a legal framework for the imposition of fines in competition matters and that 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 markets, products, the undertakings and periods concerned, are not likely to be the same (see judgment of 7 June 2007 in Britannia Alloys & Chemicals v Commission, C‑76/06 P, ECR, EU:C:2007:326, paragraph 60 and the case-law cited).

264    In any event, although the Commission, in certain cases, preferred to adopt an approach based on the demonstration of the effects on competition, that cannot deprive it of the possibility of applying the concept of restriction by object in other cases, when it is possible and justified to do so.

265    Similarly, the fact that the Commission considered in its Final Report in the Pharmaceutical Sector Inquiry that some agreements might require an in-depth analysis does not mean that it could not apply the concept of restriction by object to those agreements, if it were to transpire, following an in-depth analysis of their context, that they were, by their very nature, sufficiently harmful to competition and likely to have negative effects on competition (paragraphs 187, 188 and 212 above).

266    The applicant nevertheless considers that the Commission ‘changed its mind’, since the KFST had stated in a press release of 28 January 2004 that it was ‘doubtful’ whether the agreements at issue were anticompetitive and that the Commission considered that that type of agreements was in a ‘grey zone’.

267    In that respect, while it is true that that document referred to the Commission’s opinion regarding the anticompetitive character of the agreements at issue, it must be pointed out that it is not a press release issued directly by the Commission or by its services but rather a press release issued by a national competition authority. According to the case-law, 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 Article 101 TFEU (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).

268    In any event, that document clearly states that, following a preliminary assessment, there were doubts as to whether or not those agreements were restrictive of competition, in view inter alia of the size of the payment made by Lundbeck to the generic producers, and that the Commission was therefore going to launch a broader investigation into that type of agreements in the pharmaceutical field. Similarly, it is clear from the KFST press release that all agreements whose object is to acquire market exclusion of a competitor are anticompetitive.

269    It is precisely following that investigation, which allowed it to get a clearer idea of the operation of settlement agreements in the pharmaceutical sector, that the Commission initiated proceedings on the basis of Article 101(1) TFEU against Lundbeck and generic producers such as the applicant.

270    The applicant therefore cannot succeed in its argument that the Commission changed its stance and that this precluded it from applying the concept of restriction by object to the agreements at issue, since it is precisely following an in-depth investigation of the pharmaceutical sector that the Commission was able to clarify its approach and fully understand the anticompetitive nature of certain agreements, in particular those involving significant reverse payments, as in the present case, by carrying out an in-depth assessment of their content, their context and their purpose (recitals 638 to 641 of the contested decision).

271    The applicant also invokes the Actavis judgment, cited in paragraph 255 above, in order to support its argument that the Commission should have examined the specific effects of the agreements at issue, rather than applying the concept of restriction by object.

272    Even if the applicant’s interpretation of the Actavis judgment, cited in paragraph 255 above, were well founded and the approach adopted by the Commission in the contested decision did not correspond to the approach preferred by the Supreme Court of the United States, it has already been held that a position adopted by United States law cannot take precedence over that adopted by EU law and that an infringement of United States 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).

273    In any event, the judgment containing the majority opinion of the Supreme Court of the United States in the case that gave rise to the judgment in the Actavis, cited in paragraph 255 above — and not the dissenting opinion of Chief Justice Roberts — clearly establishes that the fact that an agreement falls within the scope of a patent does not make that agreement exempt from an antitrust action. Since the concept of restriction by object does not exist in United States law and is not comparable to the ‘per se’ rule because of the possibility of justifying that restriction under Article 101(3) TFEU, it is not correct to equate the ‘rule of reason’ in United States law with the examination of effects under Article 101(1) TFEU, as the applicant suggests. Moreover, contrary to the applicant’s submission, the contested decision is not based on assumptions, but on a detailed and minute analysis of the agreements at issue, their content, their purpose and their context, leading to the conclusion that they restrict competition by their very object.

274    Lastly, the applicant submits that an approach based on effects would have been compatible with the examination of non-challenge clauses in settlement agreements carried out by the Court of Justice in the Windsurfing judgment, cited in paragraph 225 above (EU:C:1986:75). According to the applicant, it did not undertake, in the agreements at issue, not to challenge Lundbeck’s patents.

275    In recital 601 of the contested decision, the Commission referred to the Windsurfing judgment, cited in paragraph 225 above (EU:C:1986:75), in which the Court of Justice considered that a provision imposing an obligation on licensees not to challenge the validity of licensed patents manifestly did not fall within the specific subject matter of the patent, which could not be interpreted as also affording protection against actions brought in order to challenge the patent’s validity, in view of the fact that it is in the public interest to eliminate any obstacle to economic activity which may arise where a patent was granted in error. The Court therefore regarded that obligation as an unlawful restriction of competition (the Windsurfing judgment, cited in paragraph 225 above, EU:C:1986:75, paragraphs 92 and 93).

276    The Commission submits that it referred to that judgment in support of the principle that an agreement restricts competition if it precludes the possibility of competition unrestrained by a given patent and the principle that an agreement is not immune from competition law simply because it relates to a patent. However, contrary to the applicant’s assertion, the Commission does not submit that the agreements at issue contained non-challenge clauses analogous to those at issue in the case that gave rise to the Windsurfing judgment, cited in paragraph 225 above (EU:C:1986:75). The Commission only took account of the fact that those agreements do not contain any provision allowing Merck (GUK) to directly enter the market after their expiry, while providing that Lundbeck would undertake not to bring infringement actions against Merck (GUK) at that time.

277    It is irrelevant, therefore, whether or not Merck (GUK) was precluded from challenging the validity of Lundbeck’s patents during the term of the agreements at issue, since the Commission did not erroneously rely on the presence of such non-challenge clauses in the agreements at issue in order to find a restriction of competition by object in the contested decision (paragraph 31 above).

278    Accordingly, that complaint must also be rejected.

4.     The fourth part, alleging that the Commission erred in law in its assessment of the relevance of the reverse payments as regards Article 101(1) TFEU

279    The applicant takes issue with the distinction which the Commission draws in the contested decision between, on the one hand, patent settlement agreements which make no provision for compensation for the generic undertaking and, on the other hand, those which make provision for such payment in return for its commitment not to sell the generic version of the patented medicinal product during the period covered by the patent. According to the approach taken by the Commission, whereas the first category of agreements is not contrary to Article 101(1) TFEU, the second category is. Such a distinction is illogical, according to the applicant, since the fact that the originator undertaking may choose to pay the generic undertaking in the context of a settlement agreement has absolutely no impact on competition.

280    The applicant maintains that the presence of a reverse payment is not relevant for the assessment of the restrictive nature of a settlement agreement. The Commission’s approach, according to which the commitment not to enter the market does not result from the parties’ assessment of the merits of the exclusive right itself, but from a transfer of value which overshadows that assessment and induces the generic undertaking not to pursue its own efforts to enter the market, is fallacious and incorrect. Such an approach fails to take account of the asymmetry of risks and profits at stake between a patent holder convinced of the validity of the patent and the generic undertaking: even where the patent holder’s legal position is strong there is still a risk of failure and that small risk provides the greatest incentive to conclude a settlement agreement. The Commission was wrong to rely on the idea that the existence of a reverse payment can be assimilated to a weak patent, when the relevant question is whether the agreements at issue restricted competition by comparison with the situation that would have prevailed in their absence.

281    In addition, the Commission’s approach — that the patent holder paid the generic undertaking for the certainty that the generic undertaking would not enter the market during the period of the agreements, rather than endure the uncertainty of the possible marketing of the generic citalopram in the event of an infringement action — is contrary to the Commission’s position on non-challenge clauses. First, if the Commission’s approach were to be followed, each patent settlement agreement providing for reverse payment would constitute an infringement by object of Article 101(1) TFEU, even where that settlement fell within the scope of the patent, even if the patent was valid and infringed and would in all likelihood have been held to have been infringed and even if the market entry of the generic medicinal product would not have been quicker in the absence of such a settlement. Secondly, in considering that the settlement of a patent dispute by means of a payment does not fall within the specific subject matter of the patent, the Commission disregarded the logic attached to intellectual property rights, since the outcome of an infringement action is always uncertain (even a strong case would have no more than a 70% chance of success). The agreements at issue could therefore be contrary to Article 101(1) TFEU only if it were found that they had anticompetitive effects and not by considering that a settlement agreement providing for a reverse payment constitutes, as a matter of principle, an infringement by object.

282    The Commission disputes those arguments.

283    It must be recalled, in that respect, that the Commission did not state that the existence of a reverse payment, the amount of which seemed to correspond to the profits expected by the generic undertaking, was sufficient to establish an infringement of the provisions of the Treaty concerning free competition in the present case. On the contrary, the Commission considered that settlement agreements providing for some payments, even reverse payments, were not always problematic from a competition law perspective, provided that those payments were linked to the strength of the patent concerned, as perceived by each of the parties, and that they 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 the company Neolab Ltd, with which Lundbeck had also concluded a settlement agreement, which was not considered to be problematic — even though it involved a reverse payment — since that payment to Neolab had been accompanied by, on the one hand, a commitment on Neolab’s part not to seek damages from Lundbeck before the competent courts and, on the other hand, a commitment on Lundbeck’s part not to bring any claims under its patents during a certain period (recitals 164 and 639 of the contested decision). In that case, the reverse payment did not constitute a payment made in exchange for exclusion from the market, but were accompanied, on the contrary, by an acceptance of non-infringement and a commitment not to hinder the market entry of generics.

284    Although it is true that, in Neolab’s case, there was also a first settlement agreement between the same parties which provided that Neolab’s entry to the market would be delayed, pending the outcome of the Lagap litigation, 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 ultimately decided to settle its litigation 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 deemed it preferable to settle its dispute with Neolab, by accepting to pay it the damages incurred in respect of the year when it withdrew 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, by contrast with the agreements at issue, the actual object of the reverse payment in the Neolab case was to settle a dispute between the parties, without, however, delaying the market entry of generics.

285    In the present case, however, the Commission rightly considered, relying on the evidence set out inter alia in recital 809 of the contested decision, that the existence of a reverse payment — the amount of which corresponded, in Merck (GUK)’s view, to the profits that it estimated it would be able to obtain by entering the citalopram market with its generic products — was one of the relevant factors to be taken into account as a contextual element in establishing the existence of a restriction of competition by object within the meaning of Article 101(1) TFEU (paragraph 31 above and recital 824 of the contested decision).

286    In any event, the Commission cannot be required to show that the reverse payments exceeded the profits expected by Merck (GUK) if it marketed its generics in order to show the existence of a restriction by object. The mere existence of a reverse payment could therefore be taken into account by the Commission as a relevant contextual element, in order to establish the existence of such a restriction. In the absence of any plausible alternative explanation, that payment may be regarded as being consideration for the restrictions imposed by the agreements at issue, since it is not certain that Merck (GUK) would have accepted those restrictions in the absence of that payment and it can be seen from the evidence referred to in the contested decision that it accepted those restrictions provided that the numbers ‘stacked up’ (recital 255 and 299 of the contested decision).

287    In addition, as the Commission submits, the disproportionate nature of a reverse payment may be an indication that the patent holder paid the generic undertaking not to enter the market, as in the present case. The size of a reverse payment may indeed constitute an indicator of the strength or weakness of a patent, as perceived by the parties to the agreements at the time they were concluded, and of the fact that the originator undertaking was not initially convinced of its chances of succeeding in the event of litigation. Thus, the Commission did not err in finding, in recital 640 of the contested decision, that the higher the originator undertaking estimates the chances of its patent being found invalid or not infringed, and the higher the damage to the originator undertaking resulting from successful generic entry, the more money it will be willing to pay the generic undertakings to avoid that risk. Similarly, the Supreme Court of the United States has also held that the presence of a significant reverse payment in a patent settlement agreement can provide a surrogate for the weakness of a patent, without a court having to carry out a detailed analysis of the validity of that patent (see, to that effect, the Actavis judgment, cited in paragraph 255 above).

288    It is true that, as the applicant submits, the asymmetry of risks between the parties to the agreements may lead the originator undertaking to make a reverse payment in order to avoid all risk, even minimal, that the generic undertakings may enter the market and provoke an irreversible downward price spiral, especially when the patented product, like Cipramil in the present case, is its flagship product, representing the majority of its turnover (recital 26 and 120 of the contested decision) and the undertaking in question, like Lundbeck, is seeking a favourable window in order to launch the successor of that product on the market (recital 135 et seq. of the contested decision).

289    However, the fact that the adoption of anticompetitive behaviour may 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 in Dalmine v Commission, T‑50/00, ECR, EU:T:2004:220, paragraph 211), particularly if that behaviour consists in paying actual or potential competitors not to enter the market and sharing with those competitors the profits resulting from a monopoly rent, to the detriment of consumers, as in the present case.

290    From the applicant’s perspective, while it is true that the Commission cannot require that a undertaking take commercial risks that it does not wish to take, the steps taken and the investments made by Merck (GUK) in order to enter the market show that it was ready to run the risks that such market entry entailed (paragraphs 74 to 80 above). Accordingly, although Merck (GUK) was not required to enter the market if, having regard solely to Lundbeck’s process patents, it considered that that entry was too risky, it could not, however, conclude agreements such as the agreements at issue, by which it undertook not to enter the market with its generics in exchange for considerable reverse payments, especially where those payments correspond to the profits that it expected to make by entering the market.

291    Furthermore, the evidence set out inter alia in recitals 255 and 748 of the contested decision show that it was principally the size of the reverse payments to Merck (GUK) that induced it to accept the limits on its conduct and not the existence of Lundbeck’s process patent or even the desire to avoid the costs of potential litigation (recital 255 and 748 of the contested decision). From Merck (GUK)’s perspective, those amounts constituted compensation for lost profits, corresponding to the profits that it expected to make by entering the market, without it having to continue its efforts and bear the risks of such an entry (recitals 350 of the contested decision). In that regard, it must be pointed out that the applicant has provided no other plausible explanation as to why Lundbeck paid it EUR 19.4 million under the UK Agreement and EUR 12 million under the EEA agreement (paragraph 286 above).

292    Lastly, the applicant errs in its argument that the Commission could not apply the concept of restriction by object in the present case, since it would amount to characterising all settlement agreements containing reverse payments as agreements contrary to Article 101 TFEU, without carrying out a concrete analysis of their effects on the market. As recalled in paragraph 283 above, the Commission did not find in the contested decision that all agreements containing reverse payments were contrary to Article 101(1) TFEU; it found only that the disproportionate nature of such payments, combined with several other factors — such as, in the present case, the absence of a clause allowing Merck (GUK) to launch their generic undertakings on the market upon the expiry of the agreement at issue 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 object of the agreements at issue was to restrict competition, within the meaning of Article 101(1) TFEU, in the present case (see recitals 661 and 662 of the contested decision).

293    Accordingly, that complaint must be rejected, as must the second plea in law in its entirety.

E –  The fourth plea in law, alleging that the Commission did not take proper account of the factual, economic and legal context surrounding the agreements at issue

294    The applicant submits that the Commission failed to take account of factors which together show that, in the absence of the agreements at issue, it would not have been able to market generic citalopram any more quickly in the United Kingdom or on the other EEA markets.

295    It submits that it was aware that the launch at risk of its generic would have led to long and costly proceedings and the grant of interim measures in favour of Lundbeck. Having considered the time and cost involved in defending itself in such proceedings, it considered that they were too significant for it to risk incurring them. That is clear from a number of passages in the contested decision (recitals 245, 355, 357 and 362 of the contested decision).

296    The applicant also maintains that the agreements at issue actually had pro-competitive effects, since they gave Merck (GUK) an opportunity to take the necessary steps to ‘clear the way’ for market entry, within the meaning of the Paroxetine judgment. That is borne out by a number of items in the file, which show that Merck (GUK) thought that it would be able to enter the citalopram market after the expiry of the agreements at issue. The fact that the UK agreement was extended on two occasions was connected with the outcome of the Lagap litigation, which both parties saw as a test case that would determine the validity of Lundbeck’s crystallisation patent. The Commission’s finding that that litigation had no influence on the conclusion of the UK agreement is therefore incorrect.

297    The Commission disputes those arguments.

298    First of all, it must be borne in mind that, at the time the agreements at issue were concluded, it was in no way certain that Lundbeck would inevitably be able to block Merck (GUK)’s market entry by relying on its process patents.

299    Accordingly, in so far as, by those arguments, the applicant seeks to call into question the Commission’s finding concerning the existence of a situation of potential competition between Merck (GUK) and Lundbeck, it must be pointed out that those arguments have already been examined and rejected in the context of the sixth plea in law and the part of the fourth plea in law based on that line of argument (paragraph 182 above).

300    In addition, those arguments are not capable of calling into question the correctness of the Commission’s conclusion that the agreements at issue constituted a restriction by object for the purpose of Article 101(1) TFEU. Since Merck (GUK) was a potential competitor of Lundbeck at the time the agreements at issue were concluded and since those agreements restricted its commercial autonomy by inducing it not to continue its efforts to enter the market with its generic products during the term of those agreements, it does not avail the applicant to argue that it was not certain that it would have entered the market during the term of those agreements if they had not been concluded.

301    It must be borne in mind that Article 101(1) TFEU protects not only actual competition between undertakings in the market, but also potential competition (paragraph 82 above). Potential competition entails, by definition, a certain degree of uncertainty and the Commission cannot be required to demonstrate that the generic undertakings would undoubtedly have entered the market during the term of the agreements at issue in order to establish the existence of potential competition between Merck (GUK) and Lundbeck, nor, a fortiori, in order to establish that that potential competition was reduced or eliminated by the agreements at issue.

302    The Court considers it appropriate, however, to examine some of the arguments put forward by the applicant in the context of this plea, in so far as they are intended also to call into question the Commission’s finding, in the contested decision, relating to the context and the purpose of the agreements at issue.

303    Thus, in the first place, as regards the applicant’s argument that the agreements at issue allowed the parties to avoid long and costly litigation and the grant of interim measures in favour of Lundbeck, it must be recalled that, although it is not impossible that the intention to settle a dispute may have been one of the objectives pursued by the parties to the agreements at issue when those agreements were concluded, it was nevertheless the case that Lundbeck’s objective during the negotiations was to ensure that the generics were excluded from the market (recital 814 of the contested decision) and that it was in exchange for a substantial payment that Merck (GUK) agreed to stay out of the market for a certain period, as long as the numbers ‘stacked up’ (recital 255 of the contested decision).

304    The Commission never claimed that there was no uncertainty regarding patents, but rather that it is principally because of the size of the payments offered by Lundbeck under the agreements at issue that Merck (GUK) decided to conclude those agreements. The Commission acknowledged that the parties to the agreements at issue had eliminated the uncertainty linked, inter alia, to the potential patent litigation, but that those undertakings had done so through anticompetitive instruments, namely agreements providing for a limitation of one party’s commercial autonomy in exchange for payment. In addition, it can be seen inter alia from recitals 748, 755 and 809 of the contested decision that the amounts of the reverse payments made by Lundbeck under the agreements at issue corresponded to the profits that Merck (GUK) expected to make if it entered the market with its generic products.

305    Accordingly, the fact that those agreements could have had the additional objective of avoiding the uncertainties of potential litigation cannot call into question that conclusion, since it is settled case-law 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 188 above, EU:C:2008:643, paragraph 21 and the case-law cited). Furthermore, 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 in Bayer and Maschinenfabrik Hennecke, cited in paragraph 248 above, EU:C:1988:448, paragraph 15).

306    In addition, even if the agreements at issue could have had the objective of avoiding the costs linked to the occurrence of litigation, it must be pointed out that no reference is made to those costs or even to an estimate thereof in the agreements at issue. In addition, it must be noted that the UK agreement did not even specify the Lundbeck patent that Merck (GUK) allegedly infringed.

307    In the second place, as regards the applicant’s argument that the agreements at issue had pro-competitive effects, it must be pointed out that, even if that were the case, those pro-competitive effects would have to be examined under Article 101(3) TFEU, unless the restrictions on competition provoked by those agreements are ancillary to those effects, in that they are objectively necessary and proportional to the implementation of those effects (see, to that effect, judgment of 11 September 2014 in MasterCard and Others v Commission, C‑382/12 P, ECR, EU:C:2014:2201, paragraphs 89 to 91 and the case-law cited), which the applicant has not sought to demonstrate in the present case.

308    Article 2 of Regulation No 1/2003 provides, as does the case-law (judgment in GlaxoSmithKline Services and Others v Commission, cited in paragraph 53 above, EU:C:2009:610, paragraph 82), that it is the party relying on the application of Article 101(3) TFEU who bears the burden of proof in that respect. The applicant has not sought to demonstrate that all of the conditions for the application of Article 101(3) TFEU were satisfied in the present case, but merely referred to the arguments put forward by GUK in that respect in its action (paragraph 53 to 59 above).

309    Accordingly, that argument must necessarily be rejected.

310    In addition, it can be seen from the documents in the file that it is essentially because of the transfer of value proposed by Lundbeck that Merck (GUK) agreed to conclude the agreements at issue, and not in order to ‘clear the way’ for the marketing of its generic product or to comply with the Paroxetine judgment.

311    First, it can be seen from a Merck (GUK) internal email of 28 September 2001 that it had taken steps in order to conclude an agreement with Lundbeck as early as that date, that is to say, before the Paroxetine judgment had been delivered (recital 244 of the contested decision).

312    Secondly, Merck (GUK) had reaffirmed its intention, in a letter of 24 October 2001, that is to say, the day after the delivery of that judgment, to ‘attack [Lundbeck] by all possible means’ (recital 246 of the contested decision). Likewise, it can be seen from a meeting held between Lundbeck and Merck (GUK) on 11 December 2001 that the latter intended to launch its generics on 5 January 2002 if Lundbeck did not make a sufficiently attractive offer, irrespective of the Paroxetine judgment (recital 255 of the contested decision).

313    Thirdly, if Merck (GUK) actually sought to comply with that judgment in order to ‘clear the way’, it is difficult to understand why it agreed to deliver all of its generic citalopram products to Lundbeck so that they could be withdrawn from the market (paragraph 2.2 of the UK agreement).

314    Fourthly, the applicant does not explain how the Paroxetine judgment, delivered by a court in the United Kingdom, could have affected its competitive position in the EEA and influenced its decision not to enter the markets of other EEA States.

315    Fifthly, it must be borne in mind, as the Commission points out, that Merck (GUK) briefly entered the United Kingdom market in August 2003, because Lundbeck’s offer was not ‘good enough’ (recital 299 of the contested decision), before again withdrawing by extending its agreement with Lundbeck when the payment promised by the latter was deemed satisfactory, which removes all credibility from the applicant’s argument.

316    It must also be pointed out that, as the Commission submits, the applicant has not provided any other plausible explanation for the reverse payments made under the agreements at issue or for the size of those payments, if the intention of the parties to those agreements was indeed to ‘clear the way’ for the marketing of generic citalopram (paragraph 286 above).

317    It must also be noted that the agreements at issue do not contain any provision that would have allowed Merck (GUK) to enter the market immediately upon the expiry of those agreements without facing infringement actions brought by Lundbeck. The argument that market entry would not have occurred any more quickly in the absence of those agreements is therefore, in any event, unfounded, since it is based on the erroneous premiss that the generic products infringed Lundbeck’s patents and that those patents would have undoubtedly resisted any invalidity claims.

318    It can be seen from the evidence set out inter alia in recitals 286 and 794 of the contested decision that the objective of those agreements was to allow Lundbeck to ‘buy time’ as regards the imminent market entry of generics, regardless of the outcome of its legal actions, in order to create a window of opportunity for the launch of escitalopram (recital 135 et seq. of the contested decision). In that respect, it can be seen from the evidence set out by the Commission in recitals 129 to 132 of the contested decision inter alia that, in 2002, Lundbeck wanted to avoid a situation in which the price of its medicinal product based on the citalopram API, Cipramil, fell as a result of the market entry of generic citalopram, since that price level would have a decisive influence on the price set for Cipralex in numerous States (paragraph 247 above).

319    Lastly, the assertion that the Lagap litigation in the United Kingdom served as a test case to clear the way is unconvincing, since the initial version of the UK agreement made no reference to that litigation, which began in October 2002, after that agreement had been concluded. Moreover, it can be seen from a Lundbeck internal email of 29 September 2003 that it intended to extend the UK agreement again in the event of ‘total victory’ in the Lagap litigation (recital 305 of the contested decision). Although the first and second extensions of the UK agreement refer to that litigation, this was in all likelihood because that agreement, intended to delay Merck (GUK)’s market entry, and the payments arising from it would have been useless for Lundbeck once Lagap Pharmaceuticals or any other generic undertaking was able to enter the citalopram market in the United Kingdom, as the Commission rightly indicated in recital 685 of the contested decision and as can also be seen from recital 306 of that decision.

320    In addition, as the Commission indicated in recital 687 of the contested decision, the generic citalopram at issue in the Lagap litigation (that of the Indian company Matrix) was different from that produced by Natco which Merck (GUK) intended to market, with the result that that trial could not have been decisive as regards the applicant’s decision to conclude the agreements at issue. Even if the Matrix citalopram had been held to be infringing in the Lagap litigation, which was ultimately not the case, that could not have had any impact on Merck (GUK)’s products, which were based on the Natco citalopram. The Lagap litigation would therefore — at most — have clarified the situation as regards the validity of the Lundbeck crystallisation patent, but that question was also not resolved definitively, since the parties in that case ultimately decided to settle, at the request of Lundbeck, which feared a ‘humiliating defeat’ which would have been used against it in other jurisdictions, as can be seen from an internal Lundbeck document drafted a few days after the settlement in the Lagap litigation (recital 160 of the contested decision).

321    In addition, since the Lagap litigation concerned only the United Kingdom, its outcome could not have been decisive as regards the patent situation in the rest of the EEA. Moreover, the EEA agreement does not contain any reference to that litigation, although it was signed subsequently.

322    Accordingly, the applicant’s complaints alleging a failure to take into account the context in which the agreements at issue were concluded — and the rest of the fourth plea in law in its entirety — must be rejected.

F –  The fifth plea in law, alleging an error of assessment in the examination of the content of the agreements at issue

323    The applicant claims that the Commission made an error of assessment in interpreting the content of the agreements at issue, in particular in considering that they exceeded the scope of Lundbeck’s crystallisation patent. This plea is divided into two parts, alleging that the Commission erred in concluding (i) that the agreements at issue had limited sales of citalopram other than that produced by Natco and (ii) that the agreements at issue had been concluded irrespective of whether the Natco citalopram infringed Lundbeck’s patents.

1.     The first part, alleging that the Commission wrongly concluded that the agreements at issue had limited the sales of citalopram other than that of Natco

324    In the context of the first part of the plea, the applicant maintains, in the first place, that the UK agreement was strictly intended to prevent Merck (GUK) from selling the Natco citalopram, which in Lundbeck’s view infringed its crystallisation patent, for the entire term of that agreement, but that it did not prevent the purchase and resale of other forms of generic citalopram which did not infringe Lundbeck’s patents.

325    Thus, the Commission acknowledged that the preamble to the UK agreement covered only the Natco citalopram, but it nonetheless considered that the exclusive purchase obligation imposed by Article 3.2 of the UK agreement constituted an obligation that went beyond the scope of Lundbeck’s patents. In fact, that article contains only an obligation for Merck (GUK) to buy ‘Finished Products’, that is to say, the medicinal product Cipramil, from Lundbeck. The agreement therefore did not restrict Merck (GUK)’s freedom, on the one hand, to develop a generic version of citalopram or to purchase it from other manufacturers and, on the other hand, to manufacture, market, distribute or resell that generic version of citalopram, whether as a raw material, in bulk form or as a finished product. In addition, although Merck (GUK) may not have intended to buy citalopram which was not produced by Natco, that does not mean that the agreements exceeded the material scope of Lundbeck’s patent. In that case, the restrictions of competition resulted from the Schweizerhall agreement and not from the UK Agreement.

326    The applicant submits, in the second place, that the EEA agreement, and in particular Article 1.1, which contains an obligation for Merck (GUK) to cease the sale and supply of pharmaceutical products containing citalopram, did not cover all forms of citalopram, in spite of the wording of that article. It is necessary to place that article in its context, and in particular to take account of the preamble to the agreement, from which it is clear that the scope of that agreement is limited to sales by Merck (GUK) of the Natco citalopram, which was the only form of citalopram distributed by Merck (GUK) at the time, and which was regarded by Lundbeck as infringing its patents. In any event, according to the applicant, even on the assumption that the EEA agreement did in fact prevent Merck (GUK) from marketing citalopram-based medicinal products produced through non-infringing processes, such an obligation would have had no effect on competition in the EEA market, since the agreement with Schweizerhall required Merck (GUK) to obtain supplies of citalopram from Natco and, moreover, Merck (GUK) would not have been able to obtain a type II variation of its MA during the term of that agreement.

327    The Commission contests those arguments.

a)     The UK agreement

328    As regards, first of all, the UK agreement, the applicant maintains that that agreement covers exclusively the Natco citalopram, in respect of which there was a dispute linked to Lundbeck’s patents, which is apparent, in particular, from Articles 1.1 and 2.1 of the agreement and points B and C in the preamble to that agreement, which refer to the potentially infringing nature of the Natco citalopram.

329    The applicant takes issue, in particular, with the Commission’s interpretation, in the contested decision, of Article 3.2 of the UK agreement.

330    Article 3.2 of the UK agreement states that Lundbeck ‘agrees to sell the Finished Products and GUK agrees to exclusively purchase the Finished Products from [Lundbeck] for resale by GUK and its Affiliates in the [United Kingdom] during the Term [of the agreement]’. Those ‘Finished Products’ are defined in Article 1.1 of the UK agreement as ‘products containing citalopram in finished pack form to be supplied by [Lundbeck] to GUK pursuant to this Agreement’.

331    In that respect, it must be pointed out that, as the applicant submits, the Commission’s interpretation of Article 3.2 of the UK agreement in the contested decision, according to which Merck (GUK) undertook to purchase citalopram exclusively in the form of finished products from Lundbeck in order to sell them in the United Kingdom, to the exclusion of all other citalopram, cannot be accepted.

332    It is clear from the definition of ‘Finished Products’ in Article 1.1 of the UK agreement (paragraph 330 above) that they refer to finished products from Lundbeck, namely Cipramil. By that article, Merck (GUK) therefore only undertook to purchase Cipramil tablets from Lundbeck, with a view to their resale in the United Kingdom, under a distribution agreement. The term ‘exclusively’ used in that provision does not mean, contrary to the Commission’s assertion, that Merck (GUK) undertook to sell citalopram exclusively in the form of finished products from Lundbeck, but rather that it undertook to purchase Cipramil, for resale in the United Kingdom, from Lundbeck only, excluding other suppliers. Contrary to the Commission’s assertion in recital 779 of the contested decision, that interpretation is not absurd, since the purpose of the term ‘exclusively’ in Article 3.2 could thus have been to preclude Merck (GUK) from acquiring Cipramil from wholesalers or suppliers other than Lundbeck, in accordance with Lundbeck’s objective of increasing the volume of sales of Cipramil.

333    Furthermore, the Commission wrongly relied on point D of the preamble to the UK agreement, the wording of which is essentially identical to Article 3.2 of the agreement, in order to support its interpretation, since reference is also made in that article to ‘Finished Products’ — with upper case initial letters — which are clearly defined in Article 1.1 of that agreement.

334    In addition, as the Commission itself acknowledges in recital 781 of the contested decision, a literal interpretation of Article 3.2 of the UK agreement leads to the conclusion that that provision did not prevent Merck (GUK) from acquiring citalopram in the form of API from third parties, which would potentially have allowed it to launch another generic version of citalopram on the market.

335    It must be noted that Article 2.2 of the UK agreement provides only that Merck (GUK) undertakes to deliver to Lundbeck all of its ‘Products’, which are defined in Article 1.1 of the agreement as ‘the citalopram products ... in raw material, bulk product and finished pack form as set out in the Schedule and manufactured in accordance with the specification for Products as supplied by GUK at the date of signature [of the agreement]. Attached to Schedule 2’. That schedule actually refers to the Natco citalopram. That means that Merck (GUK) was solely required, under that provision, to deliver its existing citalopram stock, which already existed at the time the agreement was signed, and not any other type of generic citalopram, from producers other than Natco, that Merck (GUK) could have acquired subsequently. The Commission also acknowledges, in recital 763 of the contested decision inter alia, that that obligation concerned only the Natco citalopram.

336    In recital 783 of the contested decision, the Commission nevertheless considered that, if Merck (GUK) had purchased citalopram in the form of API from third parties, it would have thereby breached Article 1.3 of its supply contract with Schweizerhall (paragraph 78 above), which provided that Merck (GUK) would cover 100% of its annual demand for generic citalopram with Schweizerhall. The Commission therefore took the view, in footnote No 1435 of the contested decision, that even if it were formally possible for Merck (GUK) to enter the market with generic citalopram acquired from sources other than Natco under the UK agreement, it could not do so because of the Schweizerhall agreement. According to the Commission, those two agreements reinforced each other and must therefore be read together.

337    It must be noted, however, as the applicant submits, that such an obligation on Merck (GUK) to acquire generic citalopram from Natco exclusively, via Schweizerhall, does not arise from the provisions of the UK agreement but from the Schweizerhall agreement.

338    The Commission cannot rely on the provisions of another agreement which does not concern the same parties in order to determine the content of articles of the UK agreement and, in particular, in order to establish whether or not those articles contain restrictions going beyond the scope of Lundbeck’s patents. Such an interpretation would lead to the conclusion that any type of agreement concluded by Merck (GUK) containing restrictions concerning the Natco citalopram, which was nevertheless identified as potentially infringing by the parties to the UK agreement, went beyond the scope of Lundbeck’s patents, due to the exclusive supply obligation under the Schweizerhall agreement, which was concluded previously and between different parties.

339    Accordingly, even though Lundbeck may have been aware of the existence of the Schweizerhall agreement, the Commission cannot rely on that circumstance in order to conclude that Article 3.2 of the UK agreement was intended, in itself, to prevent Merck (GUK) from entering the market with any type of citalopram, whether or not it came from Natco, and whether or not it was deemed to be potentially infringing by the parties.

340    It is true that, as the Commission submits, in interpreting the agreements at issue, it is necessary to take into account not only their wording, but also their context and objectives. That method of interpretation cannot, however, lead the Commission to ignore the wording of the provisions of an agreement, where that wording is sufficiently clear.

341    Moreover, it must be noted, in that respect, that the Commission itself stated, in recital 635 and footnote No 1562 of the contested decision, and in reply to a question put to it by the Court, that the Schweizerhall agreement could have been terminated in the event of an infringement of Lundbeck’s patents (see paragraph 128 above). It is difficult to reconcile that interpretation of the Schweizerhall agreement with the interpretation of the UK agreement proposed by the Commission in the contested decision, according to which the restrictions went beyond the scope of Lundbeck’s patents due to Merck (GUK)’s obligation, under the Schweizerhall agreement, to purchase generic citalopram exclusively from Schweizerhall. As the applicant submits in that respect, the fact that it may not have intended to purchase citalopram that was not produced by Natco does not mean that the UK agreement contained such a restriction going beyond the scope of Lundbeck’s patents.

342    Accordingly, it must be found that the Commission did not establish to the requisite legal standard, in the contested decision, that the restrictions set out in the UK Agreement went beyond the scope of Lundbeck’s patents, that is to say that such restrictions could not have been obtained by Lundbeck before a court with jurisdiction to rule on patent-related matters if the generic products based on the Natco citalopram that Merck (GUK) intended to bring to the market had been held to be infringing and if those patents had survived any counter-claims challenging their validity.

343    However, that finding is not capable of affecting the examination of the lawfulness of the contested decision, since the complaint put forward by the applicant is ineffective, for the reasons set out below.

344    First, it must be noted that the applicant does not dispute that, under Article 1.1 of the UK agreement, it undertook not to enter the market with the Natco citalopram and that, under Articles 2.2 and 2.3 of the same agreement, it undertook to deliver the entirety of its stock of citalopram (recitals 771 and 772 of the contested decision) to Lundbeck, nor the fact that it obtained GBP 3 million from Lundbeck in exchange for that commitment (paragraph 12 above). Similarly, the applicant does not dispute that, under Article 2.7 of the UK Agreement, it undertook not to grant or license, during the term of that agreement, a copy of the MAs it had already obtained in the United Kingdom.

345    As the Commission submits, such commitments are, in any event, anticompetitive by their very object, whether or not they went beyond the scope of Lundbeck’s patents, since, far from resolving any patent dispute between the parties to the UK agreement, they were obtained in exchange for significant reverse payments and they were intended to prevent Merck (GUK) from entering the market during the term of the agreement with its generic products containing the Natco citalopram, on which it had hitherto based its entire strategy for competing with Lundbeck on the United Kingdom market.

346    As the Commission emphasised in recitals 641 and 820 of the contested decision, what matters, in that respect, is that the UK agreement transformed the uncertainty regarding the outcome of any infringement actions into the certainty that Merck (GUK) would not enter the market with its generic products during the term of that agreement, whereas the limitations on Merck (GUK)’s commercial autonomy did not arise exclusively from an evaluation, by the parties to the agreement, of Lundbeck’s patents, but rather from the size of the reverse payment which, in such a case, overshadowed that evaluation and induced Merck (GUK) not to pursue its efforts to enter the market (paragraphs 196 and 197 above).

347    Secondly, it should be pointed out, for the sake of completeness, that the Commission rightly found, in recital 784 of the contested decision inter alia, that, due to the provisions of the UK Agreement, taken in context, Merck (GUK) no longer had any incentive to purchase citalopram in the form of API from a third party, or to sell citalopram in the form of finished products other than those of Lundbeck, even though it was in principle free to do so under the UK Agreement.

348    It must be borne in mind, first of all, that Merck (GUK) undertook, under Article 3.2 of the UK agreement, to sell Lundbeck’s Cipramil in the United Kingdom during the term of the agreement and that, under Article 6.2 of that agreement, the payment of GBP 5 million, described as ‘net profits’, was conditional upon the sale of a certain volume of those medicinal products in the United Kingdom during the term of that agreement. It must also be noted that the sum in question was to be paid in several tranches, which allowed Lundbeck to ensure satisfactory performance of the agreement.

349    Accordingly, even though Merck (GUK) could, in theory, have sold types of finished products other than those of Lundbeck, it had no incentive to do so, since it was able, without taking any risks, to obtain GBP 5 million as guaranteed profits for the sale of Cipramil under Article 6.2 of the UK agreement.

350    Likewise, although Merck (GUK) could, in theory, have purchased generic citalopram in the form of API from a third party, it had no incentive to do so, since it had already undertaken, under the Schweizerhall agreement, to obtain all the generic citalopram it needed from Natco for eight years. Furthermore, even if the Schweizerhall agreement could have been terminated and the applicant had been able, despite everything, to switch to another API producer, it had no incentive to sell that API itself in the form of finished products, for the same reasons as set out in paragraph 349 above, and, moreover, as the Commission notes in recital 784 of the contested decision, there is no apparent reason why third parties would purchase generic citalopram in the form of API from Merck (GUK), in order to resell it in the form of finished products in the United Kingdom, if they could purchase it directly from the API producer or from its preferred supplier.

351    Accordingly, the applicant’s argument that the Commission wrongly concluded that the UK agreement had limited the sales of citalopram other than that produced by Natco or, in other words, that it did not contain restrictions going beyond the scope of Lundbeck’s patents, as defined in paragraphs 196 and 342 above, must be rejected as ineffective.

b)     The EEA agreement

352    As regards the EEA agreement, the applicant also submits that that agreement, and in particular Article 1.1 thereof, does not cover all forms of citalopram, only Natco citalopram, with the result that it does not go beyond the scope of Lundbeck’s patents.

353    It must be pointed out, however, that the wording of the first sentence of Article 1.1 of the EEA agreement provides that Merck (GUK) ‘shall cease the sale and supply of pharmaceutical products containing Citalopram in the [EEA] ... (including, without limitation, ceasing to sell and supply NM Pharma AB) during the term of this Agreement’, without further details.

354    Points D and E in the preamble to that agreement indeed refer to the fact that Merck (GUK) was the distributor of products containing citalopram manufactured or delivered by Natco, and to the fact that the sale and supply of products containing citalopram by Merck (GUK) in the United Kingdom had been carried out without a licence from Lundbeck.

355    However, that does not confirm the applicant’s interpretation that Article 1.1 of the EEA agreement referred solely to the Natco citalopram.

356    If the parties to the EEA agreement had wished to refer only to the Natco citalopram, they would have referred expressly to that citalopram in Article 1.1, and in the preamble to that agreement, and not to ‘pharmaceutical products containing citalopram’ in general, as the Commission rightly points out. They could also have defined the term ‘citalopram’ so as to specify that that term covered only certain types of citalopram, produced using certain methods, as in the UK agreement (see paragraph 335 above).

357    In addition, the interpretation proposed by the applicant is implausible, when compared with the wording of Article 1.3 of the EEA agreement, pursuant to which Lundbeck undertakes not to initiate legal proceedings against Merck (GUK), provided that the latter observes Article 1.1 of the agreement. If the applicant’s interpretation were accepted, that would mean that Lundbeck undertook not to bring any infringement action against Merck (GUK), provided that the latter refrained from selling or supplying Natco citalopram within the EEA, even if it sold another version of citalopram from another producer. That is hard to reconcile with the context in which the agreements at issue were concluded, which demonstrates inter alia that Lundbeck had the firm intention to prevent any entry of generics to the market.

358    The applicant argues, however, that the Commission did not take due account of the supply agreement concluded with Schweizerhall or of the fact that it obliged the applicant to obtain all of the citalopram it required from Natco, which implies that the agreement could not cover other types of citalopram.

359    It must be pointed out, however, that even though Merck (GUK) was in principle obliged, pursuant to its supply agreement with Schweizerhall, to purchase and sell generic citalopram produced by Natco exclusively for eight years, that obligation did not arise from the provisions of the EEA agreement but from the Schweizerhall agreement (paragraph 337 above)

360    Accordingly, by imposing an obligation on Merck (GUK) to refrain from selling or supplying products containing citalopram to its affiliates or to any other third party (including NM Pharma, which had begun to sell citalopram in Sweden) during the term of the EEA agreement, Article 1.1 of that agreement contained restrictions going beyond the scope of Lundbeck’s patents, since that obligation was not limited to the citalopram deemed potentially infringing by the parties to that agreement.

361    Furthermore, it must be recalled that Article 1.1 of the EEA agreement not only imposed an obligation on Merck (GUK) to refrain from selling or supplying products containing citalopram for the term of the agreement, but also to use all reasonable efforts to ensure that Natco ceased to supply citalopram and products containing citalopram in the EEA during the term of the agreement.

362    Nothing indicates that that obligation was merely an insignificant, or even non-existent, commitment, as the applicant asserts. As the Commission submits, that clause was deemed sufficiently important by the parties to the agreement to be a condition for the payment of EUR 12 million. Moreover, Article 1.2 of the EEA agreement expressly provides that Lundbeck is not to be required to make any payment not yet due in the event that Natco supplies Citalopram or products containing citalopram in the EEA during the term of the agreement.

363    Accordingly, even if Merck (GUK) did not have the power to prevent Natco from supplying citalopram in the EEA, as the applicant maintains, it is nevertheless the case that Article 1.1 of the EEA agreement provided a strong incentive for Merck (GUK) to take all the necessary steps and use ‘all reasonable efforts’ in that respect, or risk losing a substantial part of the payments promised by Lundbeck under that agreement.

364    That shows, as the Commission rightly found in recital 848 of the contested decision, that the objective of the EEA agreement was not only to eliminate Merck (GUK) from the EEA markets, as a seller of generic products based on the Natco citalopram, but also to eliminate Natco as a producer of generic citalopram in that territory.

365    It must be concluded, therefore, that it is sufficiently clear from the content of the EEA agreement, read in context, that Merck (GUK) had, under the clauses of that agreement, abandoned all possibility of selling its generic version of citalopram, whether or not it came from Natco, and whether or not it potentially infringed Lundbeck’s patent.

366    Accordingly, the Commission did not err in finding, in recital 846 of the contested decision, that the EEA agreement and, in particular, Article 1.1 of that agreement, had to be interpreted as obliging Merck (GUK) to cease selling and supplying all types of citalopram in the EEA during the term of the agreement, an obligation which went beyond the scope of Lundbeck’s patents.

367    In any event, whatever the interpretation given to that agreement, and whether or not the restrictions imposed on Merck (GUK) fall within the scope of Lundbeck’s patents, those restrictions were nevertheless anticompetitive, since it had not been established that the Natco citalopram infringed one of those patents, Merck (GUK) had expressly disputed that its generic products were infringing (point G of the preamble to the EEA agreement) and the restrictions on its commercial autonomy were induced by significant reverse payments which constituted the consideration for those restrictions (paragraphs 345 and 346 above).

368    In addition, as the Commission found in recital 847 of the contested decision, the agreements at issue did not provide any consideration for the restrictions in question — such as the possibility for Merck (GUK) to enter the market immediately upon the expiry of the agreements without having to fear infringement actions from Lundbeck — other than the reverse payments promised by Lundbeck, with the result that those agreements were not intended to resolve any patent dispute.

369    Accordingly, the applicant’s argument that the EEA agreement did not contain any restriction going beyond the scope of Lundbeck’s patents must be rejected.

2.     The second part, alleging that the Commission wrongly concluded that the agreements at issue had been concluded irrespective of whether the Natco citalopram infringed Lundbeck’s patents.

370    The applicant claims, in the context of the second part of the plea, that the Commission’s finding, in recitals 768 and 844 of the contested decision, that the obligations placed on Merck (GUK) by the agreements at issue had been determined irrespective of whether or not the Natco citalopram infringed Lundbeck’s process patents is misleading. In the applicant’s submission, the very purpose of the agreements at issue, as with any other patent settlement agreement, was to amicably resolve Lundbeck’s patent claims. Since neither party could be certain whether a court would make a finding of infringement or no infringement given the vagaries of litigation, the agreements at issue were specifically concluded in order to avoid an infringement action by Lundbeck against Merck (GUK), and the time-consuming and expensive litigation that would have resulted.

371    The Commission disputes those arguments.

372    It must be observed, first of all, as the Commission noted in recital 815 of the contested decision, that the UK agreement did not even specify the patent which, according to Lundbeck, Merck (GUK) had infringed. In that context, it must be noted that, at the time that agreement was concluded, the crystallisation patent had not yet been granted definitively in the United Kingdom, with the result that it could not yet be relied on effectively in support of a potential infringement action (paragraph 139 above).

373    In addition, it must be recalled that the agreements at issue did not contain any clause allowing Merck (GUK) to enter the citalopram market directly after their expiry or providing that Lundbeck would not bring infringement actions against it at that time (paragraph 276 above).

374    Accordingly, it is at the very least doubtful that the objective of the agreements at issue was to settle a patent dispute.

375    It must also be borne in mind that the Commission did not rule out the possibility that one of the objectives pursued by the parties to the agreements at issue may have been to settle a dispute, or deny that there was uncertainty regarding patents, but it considered that, although the agreements at issue had eliminated the uncertainty linked to Lundbeck’s patents, they had done so by anticompetitive means, by imposing restrictions on Merck (GUK)’s commercial autonomy in exchange for considerable reverse payments corresponding to the profits expected by Merck (GUK) if it entered the market with the relevant generic products.

376    It is settled case-law 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 188 above, EU:C:2008:643, paragraph 21 and the case-law cited). Furthermore, 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 in Bayer and Maschinenfabrik Hennecke, cited in paragraph 248 above, EU:C:1988:448, paragraph 15).

377    Accordingly, the fact that the agreements at issue may have had the additional objective of avoiding the uncertainties of potential litigation does not call into question the existence of a restriction by object in the present case, in view of the evidence relating to the content, the purpose and the context of the agreements at issue, as found by the Commission in the contested decision and noted in paragraph 31 above.

378    Accordingly, that complaint must also be rejected, as must the fifth plea in law in its entirety.

G –  The seventh plea in law, alleging that the Commission made a manifest error of assessment in concluding that Merck (GUK) had an anticompetitive intention in concluding the agreements at issue

379    The applicant claims, in the context of this plea, that the Commission misunderstood the reasons why Merck (GUK) had concluded the agreements at issue when it found that Merck (GUK) had intended to restrict competition. Thus, as regards the UK Agreement, the finding at recital 814 to the contested decision that Merck (GUK) and Lundbeck shared an anticompetitive intention is wrong, for the following reasons.

380    First, the passages in the contested decision concerning the parties’ intentions show an anticompetitive intention on the part of Lundbeck and give minimal consideration to Merck (GUK)’s intentions.

381    Secondly, there is no precise and consistent evidence to substantiate the finding that Merck (GUK) intended to restrict competition by sharing profits in return for its exclusion from the market. A proper assessment of the evidence shows that Merck (GUK)’s behaviour was perfectly rational in the light of Lundbeck’s general conduct, in particular its threats of legal action, and in the light of the regulatory environment created in part by the Paroxetine judgment. Thus, the fact that Merck (GUK) was aware of Lundbeck’s strategy does not mean that it had anticompetitive intentions, but merely indicates that it was faced with an originator undertaking intent upon blocking the market entry of its generic. Likewise, the fact that Merck (GUK) sought to maintain profit levels by adopting an alternative course to the marketing of the generic citalopram is not proof of an anticompetitive intention, since any rational undertaking will adopt behaviour that will maximise its profits. Merck (GUK)’s intention to base its launch strategy on the most profitable and least risky course is normal commercial behaviour for an undertaking and it is not the function of competition law to require undertakings to behave otherwise.

382    Thirdly, Merck (GUK) had a commercial interest in contemplating an arrangement with Lundbeck, in order to achieve early market entry through the distribution of products bearing the Lundbeck brand. Rather than create a less competitive situation, the agreements at issue gave Merck (GUK) a window of opportunity during which it was thus able to ‘clear the way’ in order to improve the prospects of launching its generic on the market after the agreements had expired. Merck (GUK) expected, moreover, that other market operators would enter the market with their version of generic citalopram and therefore did not intend to delay the entry of generic citalopram as such.

383    Likewise, as regards the EEA agreement, the applicant disputes the relevance of the evidence used by the Commission to establish the existence of an anticompetitive intent on the applicant’s part. Merck (GUK) did not enter into the EEA agreement in order to achieve its exclusion from the market, but, rather, in order to seek a viable commercial arrangement that enabled it to find an alternative to protracted and costly legal proceedings and to the inevitable exclusion from the EEA markets to which it was exposed in the event of marketing at risk.

384    The Commission disputes those arguments.

385    It must be borne in mind, in that regard, that, according to the case-law, an anticompetitive intention by the parties is not as a matter of law a necessary factor in order to determine that an agreement is anticompetitive (paragraph 191 above).

386    In recital 803 et seq. of the contested decision, the Commission mainly examined Lundbeck’s anticompetitive intent in concluding the agreements at issue and rejected the argument of the parties to those agreements that they had intended to resolve a dispute amicably and to clarify the situation as regards Lundbeck’s patents. The Commission stated that, although this may have been one of the objectives pursued by the parties when concluding the agreements, it was nevertheless the case that one of the objectives pursued by Lundbeck in the negotiations was to exclude the generics from the market, and that, in return for a substantial payment, Merck (GUK) had agreed to stay out of the market for a certain period, as long as the numbers ‘stack[ed] up’ (recital 255 of the contested decision).

387    As the Commission rightly found, those factors clearly show the anticompetitive intention of the parties to the agreements at issue, consisting in sharing the monopoly rent, in exchange for market exclusion. The fact that the agreements may have also pursued other objectives does not call that conclusion into question, since it is settled case-law 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 188 above, EU:C:2008:643, paragraph 21 and the case-law cited).

388    Furthermore, the fact that the adoption of anticompetitive conduct may prove to be the most profitable or least risky solution for an undertaking in no way precludes the application of Article 101 TFEU (see, to that effect, judgments in Dalmine v Commission, cited in paragraph 289 above, EU:T:2004:220, paragraph 211, and in Corus UK v Commission, cited in paragraph 289 above, EU:T:2004:219, paragraph 73).

389    Moreover, it is doubtful that the parties sought to clarify the situation concerning Lundbeck’s patents, since the UK agreement did refer to any patent allegedly infringed by Merck (GUK) (recital 814 of the contested decision), Lundbeck did not undertake not to contest the potential market entry of Merck (GUK) upon the expiry of the agreements at issue and, on the contrary, Merck (GUK) undertook not to enter the market with its generic products during the entire term of the agreements, even though it disputed that those products infringed any of Lundbeck’s patents (preamble to the UK agreement). It can be seen from the documents in the file, however, that Merck (GUK) decided that it was financially more advantageous to remain outside the market and accept a payment of EUR 31.6 million by way of compensation, even though it was entirely confident that its generic product was non-infringing when the agreements at issue were signed (paragraphs 249 and 291 above).

390    Those factors therefore demonstrate to the requisite legal standard that the Commission did not err in concluding that Merck (GUK) had an anticompetitive intention in concluding the agreements at issue.

391    The seventh plea in law must therefore also be rejected.

H –  The eighth plea in law, alleging that the Commission erred in fact in its findings as to the size and purpose of the value transfer between Lundbeck and Merck (GUK)

392    By this plea, the applicant maintains that the Commission was wrong to find that all the payments made under the agreements at issue constituted a net profit for Merck (GUK), which induced the latter not to launch its generic product on the citalopram market. In fact, those payments reflect only the parties’ evaluation of the risks and the value of avoiding infringement proceedings.

393    It is appropriate to examine in succession all of the arguments put forward in the context of this plea in law.

1.     The error of assessment allegedly made by the Commission in finding that Merck (GUK)’s profits from the payments made for distribution services under the UK Agreement and its extensions amounted to GBP 9.65 million

394    The applicant submits that the Commission erred in fact in finding that GUK’s profits from the payments made for distribution services under the UK Agreement (as extended) amounted to GBP 9.65 million. In fact, Merck (GUK)’s profits from the UK agreement were significantly lower than the net profits evaluated by the Commission, which did not include the necessary distribution and warehousing costs incurred by Merck (GUK) under the UK agreement.

395    The Commission disputes those arguments.

396    It must be found, first of all, contrary to the applicant’s assertions, that the Commission did not find that all of the payments made under the agreements at issue constituted net profits for Merck (GUK). Thus, as regards the UK agreement, the Commission made a distinction, in recital 795 of the contested decision, between, on the one hand, the guaranteed profits paid pursuant to Article 6.2 of the agreement, amounting to GPB 9.65 million in total for the entire duration of the agreement, that is to say from 24 January 2002 to 1 November 2003 and, on the other hand, the GBP 3 million paid in exchange for Merck (GUK)’s stock of generic citalopram. Of that GBP 3 million, the Commission regarded only 2 million as a net profit for Merck (GUK) (recital 789 of the contested decision).

397    As regards, the fact that it did not take into account the distribution costs incurred by Merck (GUK) under the UK agreement in the amount of GPB 9.65 million, the Commission explained, in recital 790 of the contested decision, why it considered that the GPB 5 million initially paid (to which GPB 2.4 million and GPB 2.25 million were added pursuant to the two extensions of the agreement) was not linked to any distribution expenses incurred by Merck (GUK), but rather constituted a guaranteed amount, intended to compensate Merck (GUK) for its commitment not to sell generic citalopram.

398    The Commission nevertheless acknowledged, in recital 790 et seq. of the contested decision, that, although Lundbeck already had a well-developed distribution system in the United Kingdom, the distribution agreement with Merck (GUK) was not necessarily without use for Lundbeck and did not mean that Merck (GUK) had performed its distribution services without incurring any costs. However, the Commission took account of the fact that the profits that Merck (GUK) could make by selling Lundbeck citalopram were capped at 125 000 boxes per month, which allowed it to increase its profit margins by reducing the number of boxes distributed. Under Article 6.2 of the UK agreement, Merck (GUK)’s net profits from the sale of Lundbeck’s citalopram were capped at GBP 5 million, even if Merck (GUK) had ordered more than 125 000 boxes from Lundbeck during the term of that agreement. In addition, it can be seen from that provision that, if the market price of Cipramil fell, Lundbeck undertook to reduce the price at which it sold that product to Merck (GUK) in order to ensure that the latter could obtain the GBP 5 million of net profits (recital 790 of the contested decision). Lastly, the Commission took account of the fact that Merck (GUK) had itself indicated that the GBP 5 million constituted net profits, without making any deductions (recitals 294 and 797 of the contested decision).

399    The GBP 5 million of guaranteed profits, together with the GBP 2 million of profits for the delivery of Merck (GUK)’s generic citalopram stock to Lundbeck (paragraph 396 above) gives a total net profit of GBP 7 million, which corresponded to the lower end of the range of projected profits estimated by Merck (GUK) for the first year of marketing its generic (recitals 748, 755 and 809 of the contested decision). Moreover, as the Commission noted, the guaranteed net profit increased from GBP 400 000 per month to GPB 750 000 per month during the second extension of the agreement, without Merck incurring any additional distribution costs.

400    It is therefore sufficiently clear from the documents in the file that the payments totalling GBP 9.65 million were not made in consideration for distribution services but rather by way of compensation for the profits that Merck (GUK) considered it would be able to achieve if it marketed its generic citalopram. In that regard, it must be emphasised, in any event, that the applicant has not sought to give an estimate of the distribution costs that Merck (GUK) actually incurred, but has merely, by general assertions, claimed that all of the payments made under Article 6.2 of the UK agreement corresponded entirely to distribution and warehousing costs incurred by Merck (GUK), without calling into question the evidence put forward by the Commission in the contested decision in order to establish the contrary.

401    That complaint must therefore be rejected.

2.     The allegation that there is no evidence to support the finding that the payments for distribution services made by Lundbeck to Merck (GUK) were not merely payments for commercially valuable services

402    The applicant submits that there is no evidence to support the Commission’s finding that the payments for distribution services made by Lundbeck to Merck (GUK) under the UK agreement were not merely payments for commercially valuable services. Thus, in the applicant’s submission, the clause providing for a lump sum if Lundbeck should fail to deliver its finished products to Merck (GUK) at cost price (Article 6.2 of the UK agreement) did not actually give Lundbeck the option not to supply the agreed volume of citalopram. Likewise, the definition of ‘volume’ in Article 1(1) of that agreement did not impose an obligation on Merck (GUK) to order the full volume set out in the schedule. The UK agreement provided only that Merck (GUK) was entitled to receive all the net profits only if it ordered and sold the entire agreed volume. If sales were below the agreed volume, Merck (GUK) should have received the net profits in proportion to that volume. The Commission was therefore wrong to find that UK agreement entitled Merck (GUK) to receive net profits independently of the quantity of Lundbeck citalopram which it purchased and resold.

403    The Commission disputes those arguments.

404    In that respect, it must be pointed out, first of all, that the applicant’s argument is based on an erroneous premiss that all of the payments made by Lundbeck to Merck (GUK) under the UK agreement were payments made exclusively for distribution services. That assertion, which has in no way been demonstrated or supported by figures, is clearly contradicted by the content of that agreement and its context as established in the contested decision (paragraphs 389, 399 and 400 above).

405    It must be recalled that the payments due from Lundbeck under Article 6.2 of the UK agreement were independent of the quantities of Lundbeck’s Cipramil that Merck actually distributed and that the amount of those payments was capped, even if Merck (GUK) ordered more boxes from Lundbeck than the number specified in the UK agreement. Merck (GUK) was therefore certain to receive all of the guaranteed net profits, provided that it ordered the entirety of the agreed volume from Lundbeck (paragraph 398 above). In addition, if Lundbeck was not able to deliver its products for any reason, it would have to pay Merck (GUK) the profits expected by the latter.

406    Those factors sufficiently demonstrate that those payments were not made for commercially valuable distribution services, but rather in exchange for Merck (GUK)’s commitments under the UK agreement, as the Commission rightly found in recital 787 et seq. of the contested decision (paragraphs 397 to 400 above).

407    In any event, even assuming that those payments could also have been made in exchange for services of commercial value to the parties, the applicant has not demonstrated how the other provisions of the UK agreement, such as the obligation for Merck (GUK) to withdraw from the market with its generic products and to deliver the entirety of its stock of generic citalopram to Lundbeck (paragraphs 2.2 and 2.3 and point C of the preamble to the UK agreement), were provisions of a classic distribution agreement for commercially valuable services and not provisions restricting competition for which the payment of a guaranteed net profit constituted the consideration (recital 790 of the contested decision and paragraphs 398 to 400 above).

408    Furthermore, it must again be recalled 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 188 above, EU:C:2008:643, paragraph 21 and the case-law cited).

409    This complaint must therefore also be rejected.

3.     The error of assessment allegedly committed by the Commission in concluding that the GBP 3 million paid by Lundbeck for the purchase of Merck (GUK)’s stock, pursuant to the UK agreement, constituted an incentive for Merck (GUK) not to enter the market.

410    The applicant submits that the Commission incorrectly concluded that the GBP 3 million paid by Lundbeck to Merck (GUK) for the purchase of the latter’s stock, pursuant to the UK agreement, constituted an incentive for Merck (GUK) not to enter the market. The mere fact that Lundbeck purchased Merck (GUK)’s citalopram stock at the resale price, as opposed to the purchase price, is not relevant in that respect. The applicant emphasises, moreover, that the UK agreement provided that the payments made and the delivery of products by Merck (GUK) under Articles 2.2 and 2.3 of that agreement constituted full and final settlement of any claim.

411    The Commission disputes those arguments.

412    As the Commission submits, Articles 2.2 and 2.3 of the UK agreement are clear. They provide that Merck (GUK) is to receive a payment of GBP 3 million in exchange for its commitment to deliver all its generic citalopram products to Lundbeck within the prescribed periods. The Commission considered that, of that GBP 3 million, GBP 2 million constituted a net profit for Merck (GUK), in exchange for its commitment not to enter the market (paragraph 396 above).

413    The applicant merely asserts that the payment of that GBP 2 million represented the value that Lundbeck accorded to the patent settlement or the amount that Lundbeck was ready to pay in order to avoid the risk of a negative outcome in an infringement action. The fact that that amount may have represented the value, in Lundbeck’s view, of the restrictions imposed on Merck (GUK) and, inter alia, that of the delivery of its stock of generic citalopram does not mean that such an amount was necessary in order to settle a dispute, and still less that it was lawful as regards competition law.

414    This complaint must therefore also be rejected.

4.     The allegation that there is no evidence that the GUK made a profit of EUR 12 million under the EEA agreement

415    In the applicant’s submission, there is no evidence to support the Commission’s finding that Merck (GUK) made a profit of EUR 12 million under the EEA agreement. That amount was never regarded by the parties as a net profit, but mainly covered the costs associated with the supply of citalopram, distributor compensation and the costs of processing the API. The Commission’s finding that the suspension of Merck (GUK)’s commitments to its distributor did not appear to have given rise to any costs is therefore incorrect. In addition, by permitting the purchase of the API, that payment facilitated Merck (GUK)’s preparations for the launch of a generic version of citalopram once the patent situation was clarified.

416    The Commission disputes those arguments.

417    First, it must be pointed out, in that respect, that it can be seen from a Merck (GUK) internal overview of March 2003, mentioned in recital 854 of the contested decision, that Merck (GUK) itself characterised the EUR 12 million as profits, without making any deductions for any costs incurred. Secondly, it does not appear from the evidence adduced by the applicant that costs were actually incurred because of the suspension of some citalopram orders from its suppliers. As the Commission submits, the amounts referred to by the applicant therefore correspond to estimates of costs which were never actually incurred.

418    Thus, there is no evidence that Merck (GUK) had to compensate Natco or NM Pharma, which the applicant did not dispute in either the reply or at the hearing. Even though it had initially envisaged having to ‘look after’ Natco and it had considered that it was clearly preferable to pass that cost on to Lundbeck, it can be seen from an internal Lundbeck document of 28 June 2002, cited in recital 337 of the contested decision, that Lundbeck ultimately refused to provide compensation for Natco.

419    Furthermore, even if some costs may have been incurred, Merck (GUK) has not established that those costs were incurred due to the performance of the EEA agreement and that they would not have been incurred, in any event, in the absence of the agreements at issue or upon their expiry. The suspension of certain orders or of API already ordered did not generate any additional costs for Merck (GUK), since, in August 2003, it ultimately sold tablets in the United Kingdom for GPB 3 million, which clearly shows that there was no problem as regards the conservation of API and that it was able to use the tablets it had already ordered profitably (recitals 345 and 854 of the contested decision). Moreover, as the Commission explains in recital 854 of the contested decision, Merck (GUK) was able to suspend the existing API orders without incurring additional costs in that respect.

420    Therefore, even if, from Merck (GUK)’s perspective, the EEA agreement gave rise to costs amounting to EUR 12 million, the guaranteed payment from Lundbeck would have compensated it for costs that it never actually incurred or that it would in any event have incurred in the absence of that agreement. Consequently, the applicant’s allegations that Lundbeck’s payments constituted compensation for the additional costs that it incurred are not supported by any evidence. Moreover, as the Commission rightly stated in recital 855 of the contested decision and in the present action, the applicant has not provided any convincing alternative explanation concerning the size of the reverse payment made under that agreement.

421    Accordingly, it must be held that the Commission established to the requisite legal standard that it was principally the size of the reverse payment to Merck (GUK) that had induced the latter to accept the limitations on its conduct and that that payment constituted compensation for the profits that it expected to make on the market, without it having to continue its efforts and to take on the risks entailed in such market entry (recital 350 of the contested decision).

422    That complaint must therefore also be rejected, as must the eighth plea in law in its entirety.

IV –  The tenth plea in law, alleging that the Commission failed to have due regard to evidence adduced by Merck rebutting the presumption of decisive influence over its former subsidiary GUK and, consequently, erred in fact and law in finding that that presumption was not rebutted

423    The applicant claims, by this plea, that the Commission did not take proper account of the evidence it adduced in order to rebut the presumption that it exercised decisive influence over its former subsidiary GUK at the material time.

424    Thus, in its response to the statement of objections, the applicant showed, first, that there were no cross-directorships between it and GUK during the relevant period; secondly, that it and GUK maintained completely separate operations and had separate human resources, logistics, sales, production and financial services; thirdly, that GUK did not submit operational reports to it and that it was not until one month after the UK agreement had been concluded that an employee of its corporate relations department became aware of that agreement; and, fourthly, that the personnel that it seconded to GUK were treated with suspicion and kept apart from the latter’s business.

425    The applicant also denies that the control agreement concluded between it and Merck Generics could be interpreted as a legal link between GUK and itself over and above its 100% shareholding in GUK at the time. The applicant maintains that it is not so much a question of whether Merck Generics controlled GUK, but rather of determining the division of operations between itself and Merck Generics. The applicant therefore maintains that all the evidence adduced by the Commission and the intervener concerning the links between GUK and Merck Generics are irrelevant for the purpose of demonstrating that it was involved in GUK’s activities.

426    The Commission, supported by the intervener, disputes those arguments.

427    It must be borne in mind, as a preliminary point, that the competition law of the European Union covers the activities of undertakings and that the concept of an undertaking covers any entity engaged in an economic activity, regardless of its legal status and the way in which it is financed (see judgment of 10 September 2009 in Akzo Nobel and Others v Commission, C‑97/08 P, ECR, paragraph 54 and the case-law cited).

428    The Court of Justice has also stated that the concept of an undertaking, in that same context, must be understood as designating an economic unit even if in law that economic unit consists of several persons, natural or legal (see judgment in Akzo Nobel and Others v Commission, cited in paragraph 427 above, EU:C:2009:536, paragraph 55 and the case-law cited).

429    When such an economic entity infringes the competition rules, it falls, according to the principle of personal responsibility, to that entity to answer for that infringement (see judgment in Akzo Nobel and Others v Commission, cited in paragraph 427 above, EU:C:2009:536, paragraph 56 and the case-law cited).

430    The infringement of competition law must, however, be imputed unequivocally to a legal person on whom fines may be imposed and the statement of objections must be addressed to that person. It is also necessary that the statement of objections indicate in which capacity a legal person is called on to answer the allegations (see, to that effect, Akzo Nobel and Others v Commission, cited in paragraph 427 above, paragraph 57 and the case-law cited).

431    In addition, it is also clear from settled case-law that the conduct of a subsidiary may be imputed to the parent company in particular where, although having a separate legal personality, that subsidiary does not decide independently upon its own conduct on the market, but carries out, in all material respects, the instructions given to it by the parent company, having regard in particular to the economic, organisational and legal links between those two legal entities (see judgment in Akzo Nobel and Others v Commission, cited in paragraph 427 above, EU:C:2009:536, paragraph 58 and the case-law cited).

432    That is the case because, in such a situation, the parent company and its subsidiary form a single economic unit and therefore form a single undertaking for the purposes of the case-law mentioned at paragraphs 427 and 428 above. Thus, the fact that a parent company and its subsidiary constitute a single undertaking within the meaning of Article 101 TFEU enables the Commission to address a decision imposing fines to the parent company, without having to establish the personal involvement of the latter in the infringement (see, to that effect, judgment in Akzo Nobel and Others v Commission, cited in paragraph 427 above, EU:C:2009:536, paragraph 59 and the case-law cited).

433    In the specific case where a parent company has a 100% shareholding in a subsidiary which has infringed the European Union competition rules, first, the parent company can exercise a decisive influence over the conduct of the subsidiary and, secondly, there is a rebuttable presumption that the parent company does in fact exercise a decisive influence over the conduct of its subsidiary (see, to that effect, Akzo Nobel and Others v Commission, cited in paragraph 427 above, EU:C:2009:536, paragraph 60 and the case-law cited).

434    In those circumstances, it is sufficient for the Commission to prove that the subsidiary is wholly owned by the parent company in order to presume that the parent exercises a decisive influence over the commercial policy of the subsidiary. The Commission will then be able to regard the parent company as jointly and severally liable for the payment of the fine imposed on its subsidiary, unless the parent company, which has the burden of rebutting that presumption, adduces sufficient evidence to show that its subsidiary acts independently on the market (see judgment in Akzo Nobel and Others v Commission, cited in paragraph 427 above, EU:C:2009:536, paragraph 61 and the case-law cited).

435    It has been held in the case-law, for the same reasons as set out in paragraphs 431 to 433 above, that the presumption of liability that arises where a company holds 100% of another company’s capital applies not only where there is a direct relationship between the parent company and its subsidiary, but also where, as in the present case, that relationship is indirect through the interposition of another company (judgments of 20 January 2011 in General Química and Others v Commission, C‑90/09 P, ECR, EU:C:2011:21, paragraph 88; 14 July 2011 in Total and Elf Aquitaine v Commission, T‑190/06, ECR, EU:T:2011:378, paragraph 42, and of 6 March 2012 in FLSmidth v Commission, T‑65/06, EU:T:2012:103, paragraph 27).

436    In the present case, the Commission found, in recital 1243 of the contested decision, that GUK, the company which concluded the agreements at issue with Lundbeck, was indirectly wholly owned by Merck at the time those agreements were concluded and that it could therefore be presumed that the latter exercised a decisive influence over its subsidiary.

437    In recital 1244 et seq. of the contested decision, the Commission responded to the applicant’s arguments made in reply to the Statement of Objections and intended to rebut that presumption. It considered that none of the evidence adduced was sufficient to conclude that GUK had acted independently on the market.

438    The applicant submits, nevertheless, that the body of evidence submitted in reply to the Statement of Objections should have led the Commission to conclude that the presumption that it exercised a decisive influence over its subsidiary had been rebutted.

439    That argument cannot be upheld.

440    It must be pointed out, first of all, that the applicant does not dispute the evidence put forward by the Commission in recital 1244 et seq. of the contested decision in response to its arguments which confirms the existence of a presumption of decisive influence over its subsidiary GUK in the present case, but seeks only to minimise its importance or merely repeats the same arguments put forward to the Commission in reply to the Statement of Objections.

441    Accordingly, inasmuch as the applicant makes a general reference to the pieces of evidence adduced by the Commission in the context of the administrative procedure, which are reproduced in Annex 14 of the application, it must be recalled that such a general reference to other documents, even documents annexed to the application, in support of arguments which are not substantiated in the application, must be declared inadmissible in view of the case-law cited in paragraphs 56 and 57 above.

442    In addition, the applicant submits, first of all, that the fact that it seconded one of its executives to GUK in order to establish consistent procurement practices in the two groups does not indicate that it was perfectly aware of GUK’s activities. That executive did not send it reports on operational matters, but solely on questions relating to employment and human resources, and that secondment was unsuccessful, since the executive in question was treated with suspicion and shut out of GUK’s business.

443    However, as the Commission observed in recital 1247 of the contested decision, even if that secondment was unsuccessful — which seems unlikely in view of its duration (almost six years) — that would not suffice to call into question the existence of an economic unit between the two companies, since the very ability to impose such a secondment shows that Merck was actively involved in the management of its subsidiary. The Commission therefore did not disregard the evidence put forward by the applicant in that respect, as the applicant submits, but rather considered, rightly, that that evidence was not sufficient to rebut the presumption that Merck exercised a decisive influence over its subsidiary.

444    In addition, the applicant submits that the inquiries sent by Merck’s press service to GUK concerning the UK agreement — mentioned by the Commission in recital 1250 of the contested decision, in order to establish that Merck operated as a conglomerate as regards communication — actually indicate that it only found out about the agreements concluded by GUK after the fact.

445    In that regard, it must be recalled that it is not because of a relationship between the parent company and its subsidiary in instigating the infringement or, a fortiori, because the parent company is involved in the infringement, but because they constitute a single undertaking in the sense described above that the Commission is able to address the decision imposing fines to the parent company of a group of companies (judgments of 30 September 2009 in Arkema v Commission, T‑168/05, EU:T:2009:367, paragraph 77, and in Total and Elf Aquitaine v Commission, cited in paragraph 435 above, EU:T:2011:378, paragraph 50). The case-law therefore does not require that the parent company was aware of the infringement at that time it was committed by its subsidiary in order for that parent company to be regarded as constituting a single undertaking for the purpose of competition law and for a fine to be imposed on it on that basis (see, to that effect, judgment of 15 July 2015 in Socitrel and Companhia Previdente v Commission, T‑413/10 and T‑414/10, ECR (Extracts), EU:T:2015:500, paragraph 252 and the case-law cited).

446    In any event, it can be seen from the evidence referred to in recital 1250 of the contested decision and from the intervener’s observations that certain Merck managers were directly informed of GUK’s commercial strategy and the implementation of the agreements at issue.

447    Thus, the executive seconded by Merck to its subsidiary GUK, [confidential], (1) was directly responsible for strategic communication with Natco during the term of the agreements at issue and was responsible for explaining, inter alia, Merck Generics’ future strategy with respect to the launch of citalopram after the expiry of the agreements at issue as well as the reasons why those agreements had been concluded. That executive also had to report to the head of Merck’s ‘Corporate Procurement’ department, [confidential], with respect to his business targets. As the Commission found, those factors sufficiently demonstrate Merck’s direct involvement in GUK’s illegal activities.

448    In addition, it can be seen from the documents in the file, and it has not been disputed by the applicant, that the managing director of GUK, [confidential], who co-signed the EEA agreement with Lundbeck, was at that time also the Regional Director Europe for Merck Generic’s business in Europe, the Middle East and Africa. That person reported directly to the director of Merck Generics, [confidential], who was not only aware of the agreements concluded, but also participated actively in their drafting. The latter regularly reported on the performance of his duties to the managing director of Merck, [confidential], as can be seen inter alia from the email sent on 21 February 2002, concerning the media coverage of the UK agreement recently concluded between GUK and Lundbeck.

449    In addition, as the applicant itself acknowledges, under German law, a 100% shareholding in a GmbH theoretically allows its single shareholder to exercise virtually absolute power by replacing the decisions of the management by its own decisions as shareholder. That step may even be institutionalised through an advisory council composed of members of the shareholder’s board of directors and empowered to micromanage members of the subsidiary’s board of directors, by giving that council the power to take decisions concerning the strategic and day-to-day business of that subsidiary. Accordingly, regardless of the scope of the control agreement subsequently concluded between Merck and its subsidiary Merck Generics, the Commission did not err in finding that there were links of control between Merck and its subsidiaries Merck Generics and GUK, which the applicant has not been able to rebut.

450    The tenth plea must therefore be rejected.

V –  The third plea in law, alleging infringement of the principle of legal certainty

451    By its third plea in law, the applicant maintains that the Commission breached the principle of legal certainty by finding that the patent settlement agreements had restricted competition by object in the present case, since, first, the Commission performed a U-turn as regards the lawfulness of those specific agreements and, secondly, its policy had always been that non-challenge clauses in settlement agreements did not fall within the scope of Article 101(1) TFEU. 

452    In addition, there is a manifest breach of that principle in the present case because an EU competition authority described the Commission’s viewpoint in respect of those agreements as being that they were in a grey zone that did not warrant prosecution. In an analogous case, the Commission accepted the need to take into account the fact that a new interpretation of an abstract and general norm was not foreseeable to the operators concerned. The Commission should therefore have adopted a similar approach in the present case and assessed only future agreements under competition law, as the KFST suggested it would do.

453    The Commission contests those allegations.

454    According to the case-law, the principle of legal certainty requires that EU rules enable those concerned to know precisely the extent of the obligations which are imposed on them, and that those persons must be able to ascertain unequivocally what their rights and obligations are and take steps accordingly (see judgment 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 68 and the case-law cited).

455    In the present case, contrary to the applicant’s assertions, it was not unforeseeable that agreements by which an originator undertaking pays a generic undertaking, with which it is at the very least in potential competition, for the latter not to enter the market with its generic products during the term of those agreements, and without any commitment allowing it to enter the market upon the expiry of those agreements, would be considered contrary to Article 101(1) TFEU by their very object.

456    Market-sharing or exclusion agreements are among the most serious restrictions of competition expressly referred to in Article 101(1) TFEU (paragraph 185 above).

457    In addition, the case-law has progressively clarified the concept of restriction by object for the purpose of Article 101(1) TFEU and has clearly established that that concept applies to agreements which, by their very nature, are sufficiently harmful to competition (paragraph 186 et seq. above).

458    The fact that, in the present case, the agreements were concluded in a context involving intellectual property rights, cannot allow the applicant to conclude that the Commission’s approach was entirely new or that it made a U-turn as regards its assessment of the lawfulness of those types of agreement.

459    The case-law prior to the agreements at issue specified that an agreement was not excluded from the scope of competition law simply because it concerned a patent or was intended to settle a patent dispute (see, to that effect, judgment in Bayer and Maschinenfabrik Hennecke, cited in paragraph 248 above, EU:C:1988:448, paragraph 15) and that substituting the discretionary assessment of one of the parties for the decisions of national courts in order to conclude that a patent had been infringed did not fall within the specific subject matter of the patent and therefore constituted a restriction of competition (see, to that effect, judgment in Windsurfing, cited in paragraph 225 above, EU:C:1986:75, paragraph 92).

460    Moreover, contrary to what is claimed by the applicant, it is not necessary that the same type of agreements have already been censured by the Commission in order for the agreement in question to constitute a restriction of competition by object (paragraph 212 above).

461    In addition, it is apparent from the contested decision that some generic undertakings perceived the infringing nature of agreements proposed by Lundbeck and refused to enter into such agreements precisely for that reason (recital 190 of the contested decision). Similarly, an employee of Lundbeck also reacted to certain email exchanges establishing the price and volume of citalopram purchased by Merck (GUK) from Lundbeck under the agreements at issue, stating that he ‘strongly disagree[d] with the content of this email’ and that Lundbeck and Merck (GUK) ‘[could not] and [would] not agree selling prices’, since ‘this [was] illegal’ (recital 265 of the contested decision). In a document entitled ‘Generic Citalopram update 22.11.2002’, Lundbeck had also noted that the conclusion of agreements with generic undertakings was ‘tricky’, on the ground, inter alia, that ‘it [was] illegal to block competition’ (recital 191 of the contested decision).

462    That evidence shows that the restrictions of competition imposed by the agreements at issue could reasonably be perceived by the parties to those agreements as being contrary to Article 101(1) TFEU, and this was therefore far from unforeseeable at the material time.

463    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. A law may still satisfy the requirement of foreseeability even if the person concerned has to take appropriate legal advice to assess, to a degree that is reasonable in the circumstances, the consequences which a given action may entail. This is particularly true in relation to persons carrying on a professional activity, who are used to having to proceed with a high degree of caution when pursuing their occupation. Such persons can therefore be expected to take special care in evaluating the risk that such an activity entails (see judgment of 16 September 2013 in Wabco Europe and Others v Commission, T‑380/10, ECR, EU:T:2013:449, paragraph 175 and case-law cited).

464    Lastly, it is necessary to reject the applicant’s argument that the Commission departed from its own practice concerning non-challenge clauses.

465    It must be recalled, in that respect, that the Commission did not find that the agreements at issue contained non-challenge clauses similar to those at issue in the case that gave rise to the Windsurfing judgment, cited in paragraph 225 above (EU:C:1986:75). However, the Commission took account of the fact that those agreements did not contain any provision allowing Merck (GUK) to enter the citalopram market directly after their expiry and providing that Lundbeck would not bring infringement actions against it if it did so (paragraph 276 above).

466    Likewise, the applicant’s argument that the KFST press release suggested that such agreements were not contrary to Article 101 TFEU cannot succeed, for the reasons set out in paragraph 267 et seq. above.

467    Consequently the third plea in law must be rejected.

VI –  The eleventh plea in law, concerning a breach of the reasonable time principle

468    The applicant claims that the excessive duration of the administrative procedure in the present case affected the ability of the undertakings concerned to defend themselves effectively, which, according to the case-law, has an impact on the validity of that procedure. More than eight and a half years elapsed between the date on which the Commission became aware of the agreements at issue and the date on which it opened formal proceedings against Merck and GUK. In addition, the KFST stated that the Commission would not initiate infringement proceedings in respect of the agreements at issue. That statement, in conjunction with the time that elapsed, gave rise to a lack of documents and access to potential witnesses, and affected Merck’s ability to defend itself effectively against a number of essential objections relating to the infringement that were raised by the Commission. Lastly, the fact that Merck had access to the file during the investigation did not resolve those problems.

469    The Commission disputes those arguments.

470    It must be borne in mind that compliance with the reasonable time requirement in the conduct of administrative procedures relating to competition policy 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).

471    It is also settled case-law that the question whether the duration of an administrative proceeding is reasonable must be determined in relation to 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 of 30 September 2003 in Aristoteleio Panepistimio Thessalonikis v Commission, T‑196/01, ECR, EU:T:2003:249, paragraph 230).

472    Furthermore, it must be borne in mind that the fact that a reasonable time is exceeded, even on the assumption that it is established, does not necessarily constitute a ground for annulment of the decision. 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, to that effect, judgment of 18 June 2008 in Hoechst v Commission, T‑410/03, ECR, EU:T:2008:211, paragraph 227 and the case-law cited).

473    It must also be pointed out 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 corresponding to 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 infringement concerned (judgment of 21 September 2006 in Nederlandse Federatieve Vereniging voor de Groothandel op Elektrotechnisch Gebied v Commission, C‑113/04 P, ECR, EU:C:2006:593, paragraph 42 and 43).

474    It that respect, the Court of Justice has 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, because of the passage of time and the resulting difficulty of obtaining exculpatory evidence. It is necessary, however, in such a case, that the undertakings concerned demonstrate in a sufficiently precise manner that they experienced difficulties in defending themselves against the Commission’s allegations, specifying the documents or testimonies that they could no longer obtain and the reasons why this is liable to undermine their defence (see, to that effect, judgments in Technische Unie v Commission, cited in paragraph 473 above, EU:C:2006:593, paragraphs 54 and 60 to 71, and ArcelorMittal Luxembourg v Commission and Commission v ArcelorMittal Luxembourg and Others, cited in paragraph 225 above, EU:C:2011:190, paragraph 118).

475    Likewise, 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 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 454 above, EU:C:2011:190, paragraphs 120 to 122).

476    In the present case, the applicant submits that a lack of documentation and of access to witnesses affected its ability to defend itself effectively against the objections raised by the Commission, as regards inter alia the passages of the contested decision concerning GUK’s subjective intention when it concluded the agreements at issue, GUK’s opinion on the strength of Lundbeck’s crystallisation patent and on whether Natco’s citalopram infringed that patent and, lastly, the level of profits actually made by GUK in the context of the agreements at issue.

477    As a preliminary point, it is appropriate to recall the sequence of events that led to the adoption of the contested decision (recitals 8 to 19 of the contested decision):

–        in October 2003, the Commission first became aware of the agreements at issue, through information sent to it by the KFST in the context of its investigation;

–        in January 2005, the Commission carried out inspections in Denmark, Italy and Hungary, mainly at the premises of Lundbeck;

–        in 2006, requests for information were sent to the competition authorities in all of the Member States, as well as to Lundbeck and to CF Pharma;

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

–        in January 2008, the Commission decided to launch an inquiry into the pharmaceutical sector, which resulted in the adoption of a final report on 8 July 2009;

–        in December 2009, the Commission carried out further inspections at the premises of Lundbeck Italia SpA and of Italian generic undertakings;

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

–        on 19 March 2010, the Commission sent Merck a request for information in the proceedings opened against Lundbeck;

–        on 24 July 2012, the Commission opened formal proceedings against Merck;

–        on 14 and 15 March 2013, the Commission held a hearing with the parties;

–        on 21 June 2013, the Commission adopted the contested decision.

478    First of all, it suffices to note that the second phase of the procedure lasted less than a year as regards the applicant, which cannot be regarded as excessive.

479    Next, it must be noted that the first phase of the procedure began, as regards the applicant, on 19 March 2010, when the Commission took the first measures accusing Merck of having committed an infringement, and that it ended on 24 July 2012, when the Commission notified the statement of objections.

480    The applicant submits that it is mainly because of the sale of its subsidiary GUK in 2007 that it had more difficulties in obtaining documents and witnesses for its defence, which implies that, even if its opportunities to defend itself might indeed have been jeopardised, this occurred before the Commission had even conducted the first inspections as regards the applicant. In those circumstances, any breach of the applicant’s rights of defence attributable to the Commission as a result of the excessive duration of the first phase of the administrative procedure cannot be established in the present case (see, to that effect, judgment in Technische Unie v Commission, cited in paragraph 472 above, EU:C:2006:593, paragraph 69).

481    In addition, first, in so far as the applicant relies on the date on which the Commission first became aware of the agreements at issue in order to establish that it failed to meet its obligation to adopt a decision within a reasonable period and therefore infringed the applicant’s rights of defence, it must be noted that that approach is in no way adopted in the case-law, according to which the first phase begins on the date on which the Commission takes the first measures which imply an accusation of an infringement (see, to that effect, judgment in Technische Unie v Commission, cited in paragraph 472 above, EU:C:2006:593, paragraph 43).

482    Moreover, it must 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, 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 for 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, with the result that the Commission cannot put off a decision about fines indefinitely without incurring the risk of the limitation period expiring.

483    Where there is a complete system of rules covering in detail the limitation 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).

484    Secondly, it must be noted that the duration of the first stage of the procedure — even if it could be calculated from the end of the infringement as the applicant proposes — would be almost seven years as regards the applicant. That duration can be justified by the particular circumstances of the present case, from which it is clear that, in addition to the numerous requests for information that it sent to the undertakings concerned, the Commission deemed it necessary to launch a sector inquiry in order to analyse all of the practices concerning settlements in the pharmaceutical sector and to obtain a detailed view of the competitive landscape in that sector. Thus, the whole procedure was not marked by any prolonged period of inactivity which was not justified by the Commission’s need to conduct a more general investigation in the sector concerned.

485    In addition, it must be pointed out that the Commission took account of that duration in order to grant a reduction of 10% of the amount of the fine imposed on the applicant and on the other addressees of the contested decision, in recital 1380 of the contested decision.

486    Thirdly, as regards the KFST press release, which suggested, according to the applicant, that the Commission would not bring any proceedings against it, it must be pointed out that that document clearly stated that, following a preliminary assessment, there were doubts as to whether or not the agreements in question were restrictive of competition, in view inter alia of the size of the payment made by Lundbeck to the generic producers, and that the Commission was therefore going to launch a broader investigation into that type of agreements in the pharmaceutical sector. The applicant therefore cannot validly allege that that press release induced it not to take measures to ensure its defence, and even less that such an inducement, were it established, would be attributable to the Commission and to the excessive duration of the administrative procedure before it.

487    Lastly, it must be observed, as the Commission submits, that the applicant had access to the entire administrative file and all of the evidence relied on by the Commission and did not make any specific reasoned complaint regarding the importance of accessing any element withdrawn from the file during the administrative procedure or in the course of the present action.

488    In that respect, even if, by its allegations, the applicant had satisfied the conditions of precision and specificity required by the case-law cited in paragraph 474 above, it must be noted that, in view of the KFST press release and of the sector inquiry conducted by the Commission, a diligent undertaking would have conserved any document that might be useful to its defence in any potential competition law infringement proceedings, at least until the expiry of the maximum limitation period laid down in EU law (paragraph 482 above), irrespective of the periods potentially in force under the national law of the Member States.

489    Indeed, diligence is one of the conditions set out in the case-law (paragraph 475 above) that must be satisfied in order for a party to be able to invoke an infringement of its rights of defence due to the allegedly unreasonable duration of the procedure.

490    Accordingly, in view of all the foregoing, the present plea in law must be rejected.

VII –  The thirteenth plea in law, alleging that the Commission erred in its assessment of the penalties imposed

491    The applicant claims, in the context of this plea, that the Commission’s approach when setting the fines imposed on the generic undertakings ought to have led it not to impose any fine or, at the very least, to impose only a small fine. Because it departed from its normal practice as defined in its 2006 Guidelines (paragraph 32 above), the Commission ought to have adjusted the basic amount of the fines to take account of the duration or the gravity of the infringements.

492    The Commission disputes the applicant’s arguments.

493    Before examining this plea in law, 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).

494    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 493 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).

495    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).

496    As a preliminary point, it must be borne in mind that the applicant was ordered to pay a fine of EUR 21 411 000, of which EUR 7 766 843 jointly and severally with GUK (Article 2(1) of the contested decision). That amount was calculated by taking account of the value of the payments obtained under the agreements at issue (recitals 1361 and 1374 of the contested decision) and by applying the ceiling of 10% laid down in Article 23 of Regulation No 1/2003 separately for Merck and for GUK (recital 1382 of the contested decision).

A –  The complaint alleging that the Commission was not entitled to impose a fine under Article 23(2)(a) of Regulation No 1/2003 in the present case

497    The applicant submits, primarily, that the Commission was not entitled to impose a fine on it, since any infringement committed by Merck was committed neither intentionally nor negligently. In the applicant’s submission, the Commission cannot liken the present case to one involving financial incentives to leave the market, since the reverse payments were made in order to settle probable litigation, which raised novel and complex questions about their effect on competition. The Commission has therefore not clearly established that before the adoption of the contested decision patent settlements were covered by Article 101 TFEU. In addition, the Commission was wrong to find that Merck (GUK) was aware that the agreements at issue were aimed at restricting competition, since their objective was to avoid interim injunctions and costly litigation.

498    The Commission disputes those arguments.

499    In that respect, it must be noted that the applicant repeats its arguments made in the context of other pleas according to which it was not clearly established that settlement agreements providing for reverse payments, as in the present case, infringed Article 101(1) TFEU.

500    Since all of those arguments were rejected in the context of the examination of the various pleas set out above, they must, consequently, also be rejected in the context of a plea alleging that the Commission was not entitled to impose a fine.

501    According to the case-law, it is not necessary that the applicant was actually aware that it was infringing Article 101(1) TFEU by concluding the agreements at issue in order to find that the infringement was committed deliberately or negligently, within the meaning of the first sub-paragraph of Article 23(2) of Regulation No 1/2003; rather, it must be determined whether, in view of the content of the agreements, their legal and economic context and the conduct of the parties, the parties were aware or ought to have been aware of the fact that the restrictions imposed by those agreements were liable to affect trade between Member States. In other words, the condition laid down in the first subparagraph of Article 23(2) of Regulation No 1/2003 is satisfied when 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, to that effect, judgments of 8 November 1983 in IAZ International Belgium and Others v Commission, 96/82 to 102/82, 104/82, 105/82, 108/82 and 110/82, ECR, EU:C:1983:310, paragraph 45; of 9 November 1983 in Nederlandsche Banden-Industrie-Michelin v Commission, 322/81, ECR, EU:C:1983:313, paragraph 107; and Schenker & Co. and Others, cited in paragraph 267 above, EU:C:2013:404, paragraph 37).

502    In the present case, the Commission correctly noted, in recitals 1312 and 1313 of the contested decision, that a literal reading of Article 101(1) TFEU made it clear that agreements between competitors for the exclusion of some of them from the market were illegal. The fact that, in the present case, the agreements at issue were concluded in the form of settlement agreements concerning intellectual property rights cannot allow the applicant to infer that their unlawfulness in the light of competition law was completely unforeseeable.

503    It can be seen from recital 190 of the contested decision, for example, that, when Lundbeck proposed the same type of agreement to NM Pharma, the latter stated that it could not engage in discussion on the topic due to its code of conduct and its antitrust policy. Likewise, it can be seen from recital 265 of the contested decision that — reacting to an email sent to Merck (GUK) on 18 January 2002 indicating the estimated profits that would be made if Merck (GUK) purchased Lundbeck citalopram — a Lundbeck employee commented that he ‘strongly disagree[d] with the content of this email ... [since] this [was] illegal’.

504    Likewise, it is not necessary, in order to establish an infringement of Article 101(1) TFEU, that the Commission show that the same types of practices or agreements have already been censured in relation to Article 101(1) TFEU, since it was already sufficiently established at the time the agreements at issue were concluded that the exclusion of actual or potential competitors from the market constituted a restriction of competition by object (paragraphs 456 to 463 above).

505    The Commission therefore did not err in finding, in recital 1301 of the contested decision, that the generic undertakings such as the applicant could not have been unaware that their conduct — consisting in agreeing not to enter the citalopram market with their generic medicinal products in exchange for considerable payments — constituted an intentional, or at the very least negligent, infringement of the competition rules.

506    The applicant’s first complaint must therefore be rejected.

B –  The complaint alleging a breach of the principle that penalties must have a proper legal basis

507    The applicant submits that the imposition of a fine on it was contrary to the principle of nullum crimen, nulla poena sine lege, that is to say, the principle that penalties must have a proper legal basis. That principle prohibits the imposition of a fine on the basis of an interpretation of a legislative provision that was not foreseeable at the time when the infringement was committed.

508    The Commission disputes those arguments.

509    It must be borne in mind that the principle of legal certainty and the principle that penalties must have a proper legal basis, laid down by Article 7 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950, and Article 49 of the Charter of Fundamental Rights, 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 (see, to that effect, judgment in Telefónica and Telefónica de España v Commission, cited in paragraph 96 above, EU:C:2014:2062, paragraph 148 and the case-law cited).

510    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 96 above, EU:C:2014:2062, paragraph 149 and the case-law cited).

511    In addition, 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. A law may still satisfy the requirement of foreseeability even if the person concerned has to take appropriate legal advice to assess, to a degree that is reasonable in the circumstances, the consequences which a given action may entail. This is particularly true in relation to persons carrying on a professional activity, who are used to having to proceed with a high degree of caution when pursuing their occupation. Such persons can therefore be expected to take special care in evaluating the risk that such an activity entails (see judgments of 8 July 2008 in AC-Treuhand v Commission, T‑99/04, ECR, EU:T:2008:256, paragraph 142 and the case-law cited, and in Wabco Europe and Others v Commission, cited in paragraph 463 above, EU:T:2013:449, paragraph 175 and the case-law cited).

512    In the present case, the Commission correctly noted, in recitals 1312 and 1313 of the contested decision, that a literal reading of Article 101(1) TFEU made it clear that agreements between competitors for the exclusion of some of them from the market were illegal. The fact that, in the present case, the agreements at issue were concluded in the form of settlement agreements concerning intellectual property rights cannot allow the applicant to infer that their unlawfulness in the light of competition law was completely unforeseeable (paragraphs 456 to 463 above).

513    Furthermore, it is clear from the KFST press release that agreements whose object is to acquire market exclusion of a competitor are anticompetitive. Following its detailed investigation of the pharmaceutical sector, the Commission was able to refine its approach and fully comprehend the anticompetitive nature of certain agreements, including where those agreements involve a significant reverse payment, such as in the present case (paragraphs 266 to 270 above).

514    This complaint must therefore also be rejected.

C –  The complaint alleging the existence of exceptional circumstances justifying the imposition of only a symbolic fine

515    The applicant submits, in the alternative, that the infringement found was novel and called for only a symbolic fine, in the light of paragraph 4 of the Commission’s Notice on informal guidance relating to novel questions concerning Articles [101 TFEU] and [102 TFEU] (OJ 2004 C 101, p. 78). In the applicant’s submission, the Commission cannot depart from that statement of fining policy without breaching the principle of legitimate expectations.

516    The Commission disputes those arguments.

517    It must be borne in mind, as a preliminary point, that, according to the case-law, the Commission has a margin of discretion when fixing the amount of fines, in order that it may direct the conduct of undertakings towards compliance with the competition rules. Furthermore, the fact that in the past the Commission has applied fines of a particular level for certain types of infringements does not mean that it is precluded from increasing that level within the limits indicated in Regulation No 1/2003, if that is necessary to ensure implementation of European Union competition policy. The proper application of the European Union competition rules in fact requires that the Commission may at any time adjust the level of fines to the needs of that policy (see judgment of 25 October 2011 in Aragonesas Industrias y Energía v Commission, T‑348/08, ECR, EU:T:2011:621, paragraph 293 and the case-law cited).

518    The applicant refers, however, to paragraph 4 of the informal guidance (paragraph 515 above), where it is indicated that it is the practice of the Commission to impose more than symbolic fines only in cases where it is established, either in horizontal instruments or in the case-law and practice that a certain behaviour constitutes an infringement.

519    It must nevertheless be noted that, even assuming that the informal guidance could be binding on the Commission in the same way as its guidelines (see, to that effect, judgment of 11 July 2013 in Ziegler v Commission, C‑439/11 P, ECR, EU:C:2013:513, paragraphs 59 and 60 and the case-law cited), it was adopted and published in the Official Journal of the European Union only in 2004, that is to say, after the expiry of the agreements at issue. The applicant therefore cannot rely on that guidance in order to claim that it could not have foreseen, when it concluded the agreements at issue, that anything more than a symbolic fine would be imposed on it (see, to that effect, Deltafina v Commission, T‑29/05, ECR, EU:T:2010:355, paragraph 430).

520    In any event, it was sufficiently established in practice and in the case-law that conduct aimed at excluding competitors from the market constituted a restriction of competition within the meaning of Article 101(1) TFEU (paragraphs 185 to 188 and 512 above).

521    Accordingly, that complaint must also be rejected.

D –  The complaint alleging an excessive delay in the Commission’s conduct of the investigation justifying an additional reduction of the fine

522    The applicant submits, in the further alternative, that the substantial delay in the Commission’s conduct of the investigation warrants a further reduction of the fine.

523    The Commission disputes those arguments.

524    In that respect, it must be recalled that the duration of the procedure cannot be considered excessive or unreasonable, in view of the particular circumstances of the present case (paragraphs 478 to 484 above).

525    In any event, even assuming, first, that the present part may be interpreted as also requesting the Court to reduce the amount of the fine imposed on the applicant even in the absence of an illegality justifying the annulment of the contested decision and, secondly, that the case-law of the Court of Justice stemming from the 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 penalise such a breach of the principle that action must be taken within a reasonable period, it must be pointed out that the Commission itself granted a reduction of 10% of the fine imposed on the applicant and the other addressees of the contested decision in order to take account of the duration of the procedure, in recital 1380 of the contested decision.

526    In those circumstance, the General Court considers, in the exercise of its unlimited jurisdiction, provided for in Article 31 of Regulation No 1/2003 in accordance with Article 261 TFEU (see the case-law cited in paragraphs 493 to 495 above), that it is not necessary to grant an additional reduction of the fine imposed on the applicant, since the fine imposed by the Commission appears sufficient and fair in view of the circumstances of the present case.

E –  The complaint alleging that the Commission committed a manifest error of assessment in failing to attribute full liability for the infringement to GUK

527    The applicant maintains that the Commission made a manifest error of assessment in failing to make clear what proportion of the amount of EUR 7.76 million imposed on GUK jointly and severally with Merck should be borne by each of the two companies. In the applicant’s submission, it was incumbent on the Commission to determine the relative liability of each of the parties held jointly and severally liable and it ought to have ordered GUK to pay the whole of that part of the fine, as it was solely responsible for the infringement. The applicant relies, in that respect, on the judgment of 3 March 2011 in Siemens and VA Tech Transmission & Distribution v Commission (T‑122/07 to T‑124/07, ECR, EU:T:2011:70).

528    The Commission disputes those arguments.

529    It must be noted that the judgment of the General Court invoked by the applicant was explicitly set aside on the point in question by the judgment of 10 April 2014 in Commission and Others v Siemens Österreich and Others (C‑231/11 P to C‑233/11 P, ECR, EU:C:2014:256).

530    After recalling that the rules governing EU competition law, including those relating to the Commission’s power to impose penalties, the EU law principle of personal liability for an infringement and the principle that the penalty must be specific to the offender and the offence, which must be complied with when the power to impose penalties is being exercised, relate only to the undertaking per se, not the natural or legal persons forming part of the undertaking, the Court of Justice held, in that judgment, that, while it follows from Article 23(2) of Regulation No 1/2003 that the Commission is entitled to hold a number of companies jointly and severally liable for payment of a fine inasmuch as they formed part of the same undertaking, it is not possible to conclude on the basis of either the wording of that provision or the objective of the joint and several liability mechanism that that power to impose penalties extends, beyond the determination of joint and several liability from an external perspective, to the power to determine the shares to be paid by those held jointly and severally liable from the perspective of their internal relationship (judgment in Commission and Others v Siemens Österreich and Others, cited in paragraph 529 above, EU:C:2014:256, paragraphs 56 and 58).

531    According to the Court of Justice, on the contrary, the objective of joint and several liability resides in the fact that it constitutes an additional legal device available to the Commission to strengthen the effectiveness of the action taken by it for the recovery of fines imposed for infringement of the competition rules, since that mechanism reduces for the Commission, as creditor of the debt represented by such fines, the risk of insolvency, which is part of the objective of deterrence pursued generally by competition law (see judgment in Commission and Others v Siemens Österreich and Others, cited in paragraph 529 above, EU:C:2014:256, paragraphs 59 and the case-law cited).

532    The determination, in the context of the internal relationship of those held jointly and severally liable for payment of a fine, of the shares each of them is required to pay does not pursue that dual objective. That is a contentious issue, to be resolved at a later stage, and, in principle, the Commission no longer has any interest in the matter, where the fine has been paid in full by one or more of those held liable (judgment in Commission and Others v Siemens Österreich and Others, cited in paragraph 529 above, EU:C:2014:256, paragraph 60).

533    Moreover, neither Regulation No 1/2003 nor EU law in general contain rules for the resolution of such a dispute, which concerns the internal allocation of the debt for the payment of which the companies concerned are held jointly and severally liable. In those circumstances, where there is no contractual agreement as to the shares to be paid by those held jointly and severally liable for payment of the fine, it is for the national courts to determine those shares, in a manner consistent with EU law, by applying the national law applicable to the dispute (judgment in Commission and Others v Siemens Österreich and Others, cited in paragraph 529 above, EU:C:2014:256, paragraphs 61 and 62).

534    The applicant’s assertion that the Commission erred in remaining silent on the question of the relative liability of the parties and the internal allocation of the payment of the part of the fine imposed on Merck and GUK jointly and severally is therefore incorrect.

535    It must be noted, however, that the Court of Justice also explicitly rejected, in the same judgment, the General Court’s conclusion that in the absence of any finding in the Commission’s decision imposing on several companies joint and several liability for payment of a fine that, within the undertaking, certain companies have a greater share of responsibility than others for the undertaking’s participation in the cartel during a specific period, it must be presumed that they share equal responsibility and, accordingly, must pay an equal share of the fines for which they have been held jointly and severally liable (judgment in Commission and Others v Siemens Österreich and Others, cited in paragraph 529 above, EU:C:2014:256, paragraph 69).

536    The Court of Justice held that EU law does not lay down such a rule imposing liability in equal shares that is applicable by default, since the shares to be paid by those held jointly and severally liable for payment of a fine must, subject to compliance with EU law, be determined in accordance with national law (judgment in Commission and Others v Siemens Österreich and Others, cited in paragraph 529 above, EU:C:2014:256, paragraph 70).

537    That said, the Court of Justice noted that, in principle, EU law does not preclude the internal allocation of such a fine in accordance with a rule of national law which determines the individual shares of those held jointly and severally liable by taking account of their relative responsibility or culpability for the commission of the infringement for which the undertaking of which they formed part is responsible, as well as, where appropriate, a rule applicable by default, under which, if it cannot be shown by the companies claiming that there should not be equal shares that some companies have a greater degree of responsibility than others for the undertaking’s participation in the cartel during a specific period, the companies concerned must be considered to be equally liable (judgment in Commission and Others v Siemens Österreich and Others, cited in paragraph 529 above, EU:C:2014:256, paragraph 71).

538    In the present case, the contested decision does not specify the manner in which Merck and GUK should allocate the payment of the fine imposed on them jointly and severally. Accordingly, the explanations provided by the Commission in the defence, according to which Merck and GUK are required to contribute equally to the payment of the fine imposed, although incorrect in view of the abovementioned case-law, are not such as to render the contested decision unlawful.

539    In the light of the foregoing, the thirteenth plea in law must be rejected, including as regards the exercise, by the General Court, of its unlimited jurisdiction.

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

 Costs

541    Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the Commission has applied for costs and the applicant has been unsuccessful, the latter must be ordered to bear its own costs and to pay those incurred by the Commission.

542    In accordance with Article 138(3) of the Rules of Procedure, the intervener must be ordered to bear its own costs.

On those grounds,

THE GENERAL COURT (Ninth Chamber)

hereby:

1.      Dismisses the action;

2.      Orders Merck KGaA to bear its own costs and those incurred by the European Commission;

3.      Orders Generics (UK) Ltd to bear its own costs.

Berardis Czúcz Popescu

Delivered in open court in Luxembourg on 8 September 2016.

[Signatures]

Table of contents

Summary of the facts and background to the dispute

I –  The companies involved in the present case

II –  The relevant product and the applicable patents

III –  The agreements at issue

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

V –  Contested decision

Procedure and forms of order sought

Law

I –  The admissibility of the ninth and twelfth pleas in law, alleging an infringement of Article 101(3) TFEU and a breach of the parties’ right to be heard.

II –  The sixth plea in law, alleging that the Commission erred in law and in fact in finding that Lundbeck and Merck (GUK) were potential competitors, and the fourth plea in law, in so far as it is based on the same line of argument

A –  Analysis relating to potential competition in the contested decision

1.  The situation in the United Kingdom

2.  The situation in the EEA

B –  Applicable principles and case-law

1.  The concept of potential competition

2.  The burden of proof

3.  The extent of the Court’s review

C –  The potential competition between Merck (GUK) and Lundbeck

1.  The application of the appropriate legal test to the present case and the taking into account of Lundbeck’s perception in order to find the existence of potential competition between Merck (GUK) and Lundbeck

2.  The existence of a real concrete possibility of Merck (GUK) entering the United Kingdom and EEA markets and entering into competition with Lundbeck

a)  The inevitability of litigation with Lundbeck in the event that generic citalopram entered the market:

b)  The impact of the Paroxetine judgment on Lundbeck’s opposition to the launch of generic citalopram and on the risk assessment carried out by Merck (GUK)

c)  The absence of other routes to the market which would have allowed Merck (GUK) to launch its generic on the market well before the expiry of the agreements at issue

d)  The complaint that the Commission ought to have examined the competitive situation in each EEA Member State in order to be able to conclude that there was potential competition throughout the EEA.

3.  The existence of actual competition between Lundbeck and Merck (GUK) at the material time

III –  The first, second, fourth, fifth, seventh and eighth pleas in law, alleging, in essence, infringement of Article 101(1) TFEU

A –  Applicable principles and case-law

B –  Analysis relating to the existence of a restriction of competition by object in the contested decision

C –  The first plea in law, alleging that the Commission erred in its interpretation of the concept of a restriction by object within the meaning of Article 101 TFEU

D –  The second plea in law, alleging that the theory of harm applied by the Commission is fundamentally flawed

1.  The first part, alleging that the Commission erred in law failing to have proper regard to Lundbeck’s ownership of the crystallisation patent

2.  The second part, alleging that the Commission erred in law in treating settlement agreements in relation to patents as equivalent to market exclusion agreements

3.  The third part, alleging that the Commission erred in law in failing to conduct an assessment of the actual effects of the patent settlement agreements

4.  The fourth part, alleging that the Commission erred in law in its assessment of the relevance of the reverse payments as regards Article 101(1) TFEU

E –  The fourth plea in law, alleging that the Commission did not take proper account of the factual, economic and legal context surrounding the agreements at issue

F –  The fifth plea in law, alleging an error of assessment in the examination of the content of the agreements at issue

1.  The first part, alleging that the Commission wrongly concluded that the agreements at issue had limited the sales of citalopram other than that of Natco

a)  The UK agreement

b)  The EEA agreement

2.  The second part, alleging that the Commission wrongly concluded that the agreements at issue had been concluded irrespective of whether the Natco citalopram infringed Lundbeck’s patents.

G –  The seventh plea in law, alleging that the Commission made a manifest error of assessment in concluding that Merck (GUK) had an anticompetitive intention in concluding the agreements at issue

H –  The eighth plea in law, alleging that the Commission erred in fact in its findings as to the size and purpose of the value transfer between Lundbeck and Merck (GUK)

1.  The error of assessment allegedly made by the Commission in finding that Merck (GUK)’s profits from the payments made for distribution services under the UK Agreement and its extensions amounted to GBP 9.65 million

2.  The allegation that there is no evidence to support the finding that the payments for distribution services made by Lundbeck to Merck (GUK) were not merely payments for commercially valuable services

3.  The error of assessment allegedly committed by the Commission in concluding that the GBP 3 million paid by Lundbeck for the purchase of Merck (GUK)’s stock, pursuant to the UK agreement, constituted an incentive for Merck (GUK) not to enter the market.

4.  The allegation that there is no evidence that the GUK made a profit of EUR 12 million under the EEA agreement

IV –  The tenth plea in law, alleging that the Commission failed to have due regard to evidence adduced by Merck rebutting the presumption of decisive influence over its former subsidiary GUK and, consequently, erred in fact and law in finding that that presumption was not rebutted

V –  The third plea in law, alleging infringement of the principle of legal certainty

VI –  The eleventh plea in law, concerning a breach of the reasonable time principle

VII –  The thirteenth plea in law, alleging that the Commission erred in its assessment of the penalties imposed

A –  The complaint alleging that the Commission was not entitled to impose a fine under Article 23(2)(a) of Regulation No 1/2003 in the present case

B –  The complaint alleging a breach of the principle that penalties must have a proper legal basis

C –  The complaint alleging the existence of exceptional circumstances justifying the imposition of only a symbolic fine

D –  The complaint alleging an excessive delay in the Commission’s conduct of the investigation justifying an additional reduction of the fine

E –  The complaint alleging that the Commission committed a manifest error of assessment in failing to attribute full liability for the infringement to GUK

Costs

* Language of the case: English.

1 Confidential information omitted.