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 — Rights of defence — Fines)
In Case T‑469/13,
Generics (UK) Ltd, established in Potters Bar (United Kingdom), represented by I. Vandenborre and T. Goetz, lawyers,
applicant,
v
European Commission, represented initially by J. Bourke, F. Castilla Contreras and T. Vecchi, and subsequently by Castilla Contreras, Vecchi, B. Mongin and C. Vollrath, acting as Agents, assisted by S. Kingston, Barrister,
defendant,
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 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’) 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 applicant’), 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 was informed of the agreements in question by the Konkurrence- og Forbrugerstyrelsen (KFST, the Danish authority for competition and consumers).
19 Since most of those agreements concerned the whole of the EEA or, at 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 TFEU] and [102 TFEU] (OJ 2003 L 1, p. 1) at the premises of Lundbeck and other companies active in the pharmaceutical sector. It also sent Lundbeck and another company requests for information within the meaning of Article 18(2) of that regulation.
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 companies 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 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). In Lundbeck’s case, the Commission followed the general methodology described in the those 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 none the less 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 of 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 The written part of the procedure was closed on 18 July 2014.
39 Following the judgment of 11 September 2014 in CB v Commission (C‑67/13 P, ECR, EU:C:2014:2204), the applicant requested leave to submit additional observations on the inferences to be drawn from that judgment in the present case. The Court granted that request, and therefore invited the parties to submit their written observations on the possible consequences of that judgment, in the context of measures of organisation of procedure provided for in Article 64 of the Rules of Procedure of the General Court of 2 May 1991.
40 The parties complied with that request within the prescribed period.
41 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, requested the Commission to lodge a document and put a number of questions to the parties, to be answered in writing.
42 The parties complied with those measures within the prescribed period.
43 The parties presented oral argument and replied to the questions put by the Court at the hearing on 8 October 2015.
44 The applicant claims that the Court should:
– annul the contested decision, in whole or in part;
– in the alternative, annul or reduce substantially the amount of the fine;
– order the Commission to pay the costs.
45 The Commission contends that the Court should:
– dismiss the application;
– order the applicant to pay the costs.
Law
46 In support of its action, the applicant relies on seven pleas in law. By its first four pleas in law, the applicant alleges, in essence, errors of law and assessment concerning (i) the interpretation of the concept of restriction by object stemming from Article 101(1) TFEU and its application to the agreements at issue (first, second and third pleas in law) and (ii) the conclusion that GUK and Lundbeck were potential competitors at the time the agreements at issue were concluded (fourth plea in law). The applicant’s other pleas in law concern, in essence, an infringement of Article 101(3) TFEU (fifth plea in law), an infringement of its rights of defence (sixth plea in law) and a request for annulment or reduction of the fine imposed on it (seventh plea in law).
47 It is appropriate to examine, in the first place, the fourth plea in law, then, in the second place, the first, second and third pleas in law taken together and, lastly, the applicant’s other pleas in law.
I – The fourth plea in law, alleging, in essence, that the Commission was wrong to conclude, in the contested decision, that Lundbeck and Merck (GUK) were potential competitors at the time the agreements at issue were concluded
48 The applicant argues that the Commission was wrong to conclude that Merck (GUK) had the ability to effectively launch generic citalopram on the market and that the launch of that product was an economically viable strategy in order to find that Merck (GUK) and Lundbeck were potential competitors at the time the agreements at issue were concluded. In the applicant’s submission, the Commission’s analysis is based on an incomplete assessment of the relevant facts and an erroneous application of the case-law.
49 The applicant submits that, before it has obtained a marketing authorisation (MA) within the meaning of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), no generic undertaking is entitled to launch its product, which means that it does not have the ability to enter the market within the meaning of the relevant case-law. Furthermore, the facts of the present case are different from those at issue in the case that gave rise to the judgment of 8 July 2004 in Dalmine v Commission (T‑50/00, ECR, EU:T:2004:220), which the Commission cites in support of its assertion that the absence of an MA does not mean that the product is not capable of being marketed in the near future.
50 Given that it had not received an MA in a number of EEA Member States, the applicant submits that the Commission could not conclude that Merck (GUK) had committed an infringement in the whole of the EEA without examining whether, in the absence of the settlement agreements, there would have been a real and concrete possibility of entering each of those markets and that such entry would have constituted an economically viable strategy. The Commission therefore also made an error of law in concluding that, for the purposes of finding a restriction by object, the geographic scope and the duration of the infringement were determined by the object of the agreement and not by the date on which the undertaking had the ability to enter the market.
51 In addition, the Commission failed to take account of the avalanche of process patents which Lundbeck had put into place. It seems to assume, on the contrary, that in the absence of the settlement agreements Merck (GUK) would have been able to launch its generic products immediately, which was not the case. Furthermore, the Commission erred in failing to determine whether Merck (GUK) could actually have employed some of the means of entering the market identified at recital 635 of the contested decision. In particular, the Commission was wrong to suppose that Merck (GUK) could have obtained an allegedly non-infringing generic citalopram from a source other than Natco within a reasonable period. Likewise, the Commission disregarded the evidence relating to the risks, uncertainty, duration and significant costs involved in patent litigation, or the risk that the applicant would have to pay very high damages if it entered the market ‘at risk’.
52 The Commission disputes those arguments.
53 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
54 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.
55 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 an MA pursuant to Directive 2001/83/EC, 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.
56 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.
57 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.
58 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.
59 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.
60 Accordingly, the Commission concluded that Lundbeck’s process patents were not capable of blocking all possibilities of market entry open to the generic undertakings. In recital 635 of the contested decision, it identified eight possible routes to the market in the present case:
– 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.
61 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
62 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).
63 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 market, 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).
64 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).
65 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 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 citalopram market at the time the agreements at issue were concluded.
2. The situation in the EEA
66 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).
67 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).
68 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
69 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).
70 According to the case-law, the examination of conditions of competition on a given market must be based not only on existing competition between undertakings already present on the relevant market but also on potential competition, in order to ascertain whether, in the light of the structure of the market and the economic and legal context within which it functions, there are real concrete possibilities for the undertakings concerned to compete among themselves or for a new competitor to enter the relevant market and compete with established undertakings (judgments of 15 September 1998 in European Night Services and Others v Commission, T-374/94, T-375/94, T-384/94 and T-388/94, ECR, EU:T:1998:198, paragraph 137; 14 April 2011 in Visa Europe and Visa International Service v Commission, T-461/07, ECR, EU:T:2011:181, paragraph 68; and E.ON Ruhrgas and E.ON v Commission, cited in paragraph 69 above, EU:T:2012:332, paragraph 85).
71 In order to determine whether an undertaking is a potential competitor in a market, the Commission is required to determine whether, if the agreement in question had not been concluded, there would have been real concrete possibilities for it to enter that market and to compete with established undertakings. Such a demonstration must not be based on a mere hypothesis, but must be supported by evidence or an analysis of the structures of the relevant market. Accordingly, an undertaking cannot be described as a potential competitor if its entry into a market is not an economically viable strategy (see judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 69 above, EU:T:2012:332, paragraph 86 and the case-law cited).
72 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, none the less 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 69 above, EU:T:2012:332, paragraph 87 and the case-law cited).
73 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 70 above, EU:T:2011:181, paragraph 169).
74 Moreover, it also follows from the case-law that the very fact that an undertaking already present on the market seeks to conclude agreements or to establish information exchange mechanisms with other undertakings which are not present on the market provides a strong indication that the market in question is not impenetrable (see, to that effect, judgments of 12 July 2011 in Hitachi and Others v Commission, T-112/07, ECR, EU:T:2011:342, paragraph 226, and 21 May 2014 in Toshiba v Commission, T-519/09, EU:T:2014:263, paragraph 231).
75 Although it follows from that case-law that the Commission may rely inter alia on the perception of the undertaking present on the market in order to assess whether other undertakings are potential competitors, nevertheless, the purely theoretical possibility of market entry is not sufficient to establish the existence of potential competition. The Commission must therefore demonstrate, by evidence or an analysis of the structures of the relevant market, that the market entry could have taken place sufficiently quickly for the threat of a potential entry to influence the conduct of the participants in the market, on the basis of costs which would have been economically viable (see, to that effect, judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 69 above, EU:T:2012:332, paragraphs 106 and 114).
2. The burden of proof
76 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).
77 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 76 above, EU:T:2013:188, paragraph 92 and the case-law cited).
78 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 76 above, EU:T:2013:188, paragraph 93 and the case-law cited).
79 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 76 above, EU:T:2013:188, paragraph 95 and the case-law cited).
80 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 76 above, EU:T:2013:188, paragraph 96 and the case-law cited).
81 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 76 above, EU:T:2013:188, paragraph 97 and the case-law cited).
82 Lastly, it must be pointed out that, when the Commission establishes that an undertaking has participated in an anti-competitive 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).
83 Nevertheless, where the Commission has documentary evidence of an anti-competitive 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 76 above, EU:T:2013:188, paragraphs 99 and 102 and the case-law cited).
3. The extent of the Court’s review
84 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
85 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.
86 As a preliminary point, the applicant’s argument that the Commission disregarded the relevant case-law in assessing the existence of potential competition between Merck (GUK) and Lundbeck must be rejected.
87 It is clear from, inter alia, recitals 610 and 611 of 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 70 above (EU:T:1998:198), and Visa Europe and Visa International Service v Commission, cited in paragraph 70 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.
88 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, paragraph 70 above, EU:T:2011:181, paragraph 189).
89 Next, the Court confirms the Commission’s approach, as it can be seen from the contested decision as a whole, which consisted in principally taking into account evidence prior to or contemporaneous with the date on which the 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.
90 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 could not be decisive in the examination of the existence of potential competition between the parties to the agreement at issue.
91 First, as regards the applicant’s argument that none of the generic undertakings were able to enter the market before obtaining an MA, it must noted, as the Commission pointed out, that that argument appears to disregard the distinction between actual competition and potential competition.
92 Article 101 TFEU protects not only actual competition, but also potential competition between undertakings (paragraph 70 above).
93 As the Commission noted in recitals 615 to 620 of the contested decision (paragraphs 54 and 55 above), potential competition begins well before the actual market entry of generic undertakings, in particular by their efforts to obtain the necessary MAs as well as the completion of all the administrative and commercial steps required in order to prepare their market entry. That potential competition must be protected, since, if it were possible, without infringing competition law, to pay undertakings which are taking those steps to prepare their market entry and which have made significant investments to that end to stop or simply slow that process, actual competition would never take place, or would suffer significant delays, to the detriment of consumers.
94 That reasoning is supported by the case-law established in the judgment of 6 December 2012 in AstraZeneca v Commission (C‑457/10 P, ECR, EU:C:2012:770, paragraph 108), in which the Court of Justice held that unlawful SPCs not only led to a significant exclusionary effect after the expiry of the basic patents, but were also liable to alter the structure of the market by adversely affecting potential competition even before that expiry.
95 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 anti-competitive 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 patents protecting a medicinal product and that the steps taken before that expiry are relevant in assessing whether that competition was restricted.
96 Furthermore, contrary to the applicant’s assertions, the Commission did not find in the contested decision that the patents on which Lundbeck relied had to have been enforced in legal proceedings in order to produce their effects vis-à-vis its competitors, but rather that those patents, even if they were valid, did not authorise the conclusion of agreements intended to exclude potential competitors from the market for a certain period in return for payment.
97 Thus, contrary to the applicant’s assertions, in order to conclude that there was potential competition between Merck (GUK) and Lundbeck in the entire EEA in the present case, 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 70 above, EU:T:2011:181, paragraph 168).
98 The analysis carried out by the Commission in recitals 827 to 840 of the contested decision (paragraphs 66 to 68 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.
99 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 67 above).
100 The applicant submits, however, that even such market entry cannot be regarded as proof of its ability to enter the market, since it was unlawful. In its view, this means that, even when it actually entered the United Kingdom and Swedish markets, it could not be regarded as an actual or potential competitor of Lundbeck, since it had not been established that its generic products did not infringe any of the latter’s patents.
101 That line of argument cannot succeed.
102 The case-law cited in paragraphs 69 to 75 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.
103 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 concluding the EEA agreement, without worrying about Lundbeck (paragraph 123 below).
104 In addition, the applicant’s argument is based on the erroneous premiss that, first, its generic undertakings 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.
105 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 unlawfulness of generic products validly placed on the market which the holder of a patent considers to be infringing.
106 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).
107 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.
108 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.
109 Lastly, contrary to the applicant’s assertions, it can be seen from the contested decision that the Commission took account of the differences between the EEA States when those differences appeared relevant for the purpose of its examination 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.
110 In any event, it must be noted that, according to the case-law, a restriction of competition is liable to affect trade between Member States where it is likely to divert trade patterns from the course which they would otherwise have followed. Furthermore, the capability of a cartel to affect trade between Member States, that is to say, its potential effect, is sufficient for it to fall within the scope of Article 101 TFEU and it is not necessary to demonstrate an actual effect on trade in all the Member States. As the Commission rightly noted in recital 1192 of the contested decision, the requirement that trade between Member States be affected means that there must be an effect on cross-border economic activity between at least two Member States. It is none the less necessary for the potential effect of the cartel on inter-State trade to be appreciable, or, in other words, that it be not insignificant (see judgment of 29 June 2012 in GDF Suez v Commission, T‑370/09, ECR, EU:T:2012:333, paragraphs 123 and 124 and the case-law cited).
111 The applicant’s argument therefore cannot call into question the finding of an infringement of the treaty provisions on competition in the present case, since it does not dispute that it could have obtained MAs, and indeed had obtained such MAs in at least two EEA Member States (namely Sweden and the United Kingdom), before concluding the agreements at issue and that those agreements had had an impact on the sale of its generic products in those States and on its possibilities of entering the market of other Member States through the mutual recognition procedure laid down in Directive 2001/83 (recitals 829 and 830 of the contested decision).
112 The applicant also disputes, in that respect, the reference to the judgment in Dalmine v Commission, paragraph 49 above (EU:T:2004:220), made by the Commission in recital 620 of the contested decision. The Commission indeed relied on that judgment in order to support its position that the absence of an MA did not mean that the generic product could not enter the market within a short period, as long as the generic undertaking was pursuing its efforts to obtain such regulatory approval before concluding an agreement with the originator undertaking.
113 It is true that, although the legal obstacles arising from a patent may prove to be different from the practical obstacles which were at issue in the case that gave rise to the judgment in Dalmine v Commission, paragraph 49 above (EU:T:2004:220), nevertheless the Commission did not err in finding that the existence of such obstacles is not enough to preclude the existence of potential competition between Merck (GUK) and Lundbeck at the time the agreements at issue were concluded, since it does not appear from the file that those obstacles were insurmountable in this case and that they were perceived as such by the parties to those agreements.
114 In any event, it must be recalled that Merck (GUK) had already obtained MAs in the United Kingdom, as had NM Pharma in Sweden (paragraphs 63 and 67 above), with the result that Merck (GUK)’s entry to the market in several EEA Member States was sufficiently certain and imminent at the time the agreements at issue were concluded.
115 Secondly, the applicant incorrectly submits that the Commission did not take account of Lundbeck’s new process patents, in particular the crystallisation patent.
116 The Commission found, first of all, 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. Those possible routes included, inter alia, launching the generic product ‘at risk’, with the possibility of having to face litigation brought by the originator undertaking, in this case Lundbeck.
117 That possibility represents the expression of potential competition, in a situation in which, as in the present case, the 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 inter alia 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 — 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.
118 Furthermore, 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.
119 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).
120 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.
121 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 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 e-mail 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: ‘[G]ood luck ... this does not affect us launching [our product]’ (see recital 240 of the contested decision).
122 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).
123 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 respect, 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).
124 Moreover, it is not true that Merck (GUK) would in no event have been able to obtain non-infringing citalopram 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).
125 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.
126 Lastly, the applicant wrongly submits that the Commission committed a manifest error of assessment in concluding that Merck (GUK) and Lundbeck were potential competitors by relying principally on Lundbeck’s perception in that respect.
127 The perception of market actors may, according to the case-law, constitute a relevant factor in evaluating the existence of potential competition (judgment in Hitachi and Others v Commission, paragraph 74 above, EU:T:2011:342, paragraph 226), even though that analysis must first of all be based on objective factors (see the case-law mentioned in paragraphs 70 to 75 above).
128 Furthermore, it must be pointed out that, 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 63 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.
129 Accordingly, in view of all the foregoing, the fourth plea in law must be rejected.
II – First, second and third pleas, alleging, in essence, infringement of Article 101(1) TFEU
130 By its first, second and third pleas in law, the applicant essentially contests the Commission’s assessment, in the contested decision, of the content, the purpose and the context of the agreements at issue in finding that there was, in the present case, a restriction of competition by object, within the meaning of Article 101(1) TFEU. It considers that, in reaching that conclusion, the Commission disregarded the presumption of validity enjoyed by Lundbeck’s patents. It also calls into question the Commission’s assessment of the payments made by Lundbeck under the agreements at issue.
131 Before examining the applicant’s arguments relating to the content, the purpose and the context of the agreements at issue, 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’.
A – Applicable principles and case-law
132 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.’
133 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 39 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).
134 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 39 above, EU:C:2014:2204, paragraph 50; see also, to that effect, judgment in Allianz Hungária Biztosító and Others, cited in paragraph 133 above, EU:C:2013:160, paragraph 35 and the case-law cited).
135 Consequently, it is established that certain collusive behaviour, such as that leading to horizontal price-fixing by cartels or consisting in the exclusion of some competitors from the market, may be considered so likely to have negative effects, in particular on the price, quantity or quality of the goods and services, that it may be considered redundant, for the purposes of applying Article 101(1) TFEU, to prove that they have actual effects on the market. Experience shows that such behaviour leads to falls in production and price increases, resulting in poor allocation of resources to the detriment, in particular, of consumers (judgment in CB v Commission, cited in paragraph 39 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).
136 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 133 above, EU:C:2013:160, paragraph 34, and CB v Commission, cited in paragraph 39 above, EU:C:2014:2204, paragraph 52).
137 In order to establish the anti-competitive 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 (judgment in CB v Commission, cited in paragraph 39 above, EU:C:2014:2204, paragraph 53; see also, to that effect, judgment in Allianz Hungária Biztosító and Others, cited in paragraph 133 above, EU:C:2013:160, paragraph 36).
138 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 (see judgments in Allianz Hungária Biztosító and Others, cited in paragraph 133 above, EU:C:2013:160, paragraph 37 and the case-law cited, and CB v Commission, cited in paragraph 39 above, EU:C:2014:2204, paragraph 54 and the case-law cited).
B – Analysis relating to the existence of a restriction of competition by object in the contested decision
139 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).
140 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).
141 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).
142 It can also be seen from the contested decision that, although the restrictions set out in the agreements at issue fell within the scope of the Lundbeck patents (that is to say that those agreements prevented only the market entry of generic citalopram deemed by the parties to those agreements to potentially infringe those patents and not that of every type of generic citalopram), they were nevertheless 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).
143 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).
144 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).
145 The applicant’s arguments concerning the content, the context and the purpose of the agreements at issue seeking to call into question the existence of a restriction by object in the present case must be examined in the light of those considerations.
C – Examination of whether there is a restriction of competition by object within the meaning of Article 101(1) TFEU
146 As a preliminary point, it is appropriate to examine the applicant’s arguments alleging that the Commission misconstrued the concept of restriction of competition by object, as set out in the recent case-law of the Court of Justice, in particular the judgment in CB v Commission, cited in paragraph 39 above (EU:C:2014:2204).
147 The applicant submits, in its further observations submitted following the judgment in CB v Commission, cited in paragraph 39 above (EU:C:2014:2204), first, that it clearly followed from that judgment that the Commission had not sufficiently explained why the agreements at issue were in themselves sufficiently harmful to competition, secondly, that the contested decision had not identified the experience that would allow it to conclude that the agreements at issue were so likely to restrict competition that it was not necessary to examine their effects and, thirdly, that the contested decision did not establish how the agreements at issue had fundamentally changed the structure of the market, as in the case that gave rise to the BIDS judgment, cited in paragraph 135 above (EU:C:2008:643), with the result that they could not be regarded as a restriction by object.
148 However, it can be seen from the case-law cited above, in particular the judgment in CB v Commission, cited in paragraph 39 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.
149 It is true that, in its judgment in CB v Commission, cited in paragraph 39 above (EU:C:2014:2204), the Court of Justice rejected the General Court’s analysis in the judgment of 29 November 2012 in CB v Commission (T-491/07, 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 (judgment in CB v Commission, cited in paragraph 39 above, EU:C:2014:2204, paragraph 58).
150 However, it does not follow that the Commission is required to examine the effects of an agreement if it is able to establish, to the requisite legal standard, that it may be considered — in view of its content, the scope of its provisions and its objectives, taken in their economic and legal context — to be sufficiently harmful to competition (paragraphs 135 to 137 above).
151 Moreover, contrary to what is claimed by the applicant, it is not necessary that the same type of agreement 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 39 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 39 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).
152 Furthermore, it must be recalled that, contrary to the applicant’s assertions, the concept of a restriction of competition by object does not give rise to a presumption, since it is for the Commission to establish, on the basis of objective evidence, that the requirements for a finding of a restriction by object are met. Still less is it 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 of 13 October 2011 in Pierre Fabre Dermo-Cosmétique, C‑439/09, ECR, 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).
153 Accordingly, 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.
1. The content of the agreements at issue
154 As regards, first of all, the content of the agreements at issue, the applicant submits that the Commission made a manifest error of assessment when it considered that those agreements were intended to restrict GUK’s activities and that those restrictions exceeded the scope of Lundbeck’s existing patents.
a) The UK agreement
155 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, which refer to the potentially infringing nature of the Natco citalopram.
156 The applicant takes issue, in particular, with the Commission’s interpretation, in the contested decision, of Article 3.2 of the UK agreement.
157 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’.
158 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.
159 It is clear from the definition of ‘Finished Products’ in Article 1.1 of the UK agreement (paragraph 157 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.
160 Moreover, contrary to the Commission’s assertion, the applicant has never accepted that the expression ‘Finished Products’ used in the UK agreement could cover types of finished products other than those of Lundbeck, as defined in Article 1.1 of the UK agreement, with the result that it undertook not to launch any type of generic citalopram.
161 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.
162 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.
163 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.
164 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 66 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.
165 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.
166 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. As the applicant submits, 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.
167 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.
168 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.
169 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 124 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.
170 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.
171 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.
172 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.
173 As the Commission submits, such commitments are, in any event, anti-competitive 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.
174 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 142 and 143 above).
175 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.
176 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.
177 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.
178 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 177 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) if they could purchase it directly from the API producer or from its preferred supplier.
179 Accordingly, the applicant’s argument that the UK agreement did not contain restrictions going beyond the scope of Lundbeck patents, as set out in paragraphs 142 and 170 above, must be rejected as ineffective. In addition, the argument that the UK agreement was not intended to restrict Merck (GUK)’s activities must be rejected as unfounded.
b) The EEA agreement
180 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 and it is not intended to restrict its activities unduly.
181 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.
182 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 in the United Kingdom by Merck (GUK) had been carried out without a licence from Lundbeck.
183 However, that does not confirm the applicant’s interpretation that Article 1.1 of the EEA agreement referred solely to the Natco citalopram.
184 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 163 above).
185 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.
186 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.
187 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 165 above)
188 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.
189 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.
190 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.
191 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.
192 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.
193 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.
194 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.
195 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 anti-competitive, 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.
196 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.
197 Accordingly, the applicant’s argument that the EEA agreement was not intended to restrict its activities unduly and did not contain any restrictions going beyond the scope of Lundbeck’s patents must be rejected.
c) The alleged absence of certain references in the agreements at issue.
198 The applicant submits that the Commission incorrectly stated in the contested decision that the relevant process patents were not even identified (recital 753 of the contested decision), that it was unlikely that the agreements at issue would clarify the patent situation (recital 814 of the contested decision) and that no litigation was pending between the parties (recital 681 of the contested decision), even though it recognised that a potential dispute between the parties was imminent in its analysis of potential competition. Lastly, the applicant challenges the Commission’s assertion that Merck (GUK)’s commitment was not given in exchange for consideration in the form of a commitment from Lundbeck not to initiate infringement proceedings if Merck (GUK) placed generic citalopram on the market (recital 769 of the contested decision).
199 As regards the applicant’s allegations that the Commission relied on certain considerations relating to the existence of litigation between Lundbeck and Merck (GUK) in order to support its finding of potential competition between them, whereas, in its examination of the agreements at issue, it maintained that there was no litigation between the parties, it must be pointed out that those allegations arise from an erroneous reading of the contested decision.
200 The Commission found, in recital 681 of the contested decision inter alia, that there was no litigation between Lundbeck and the various parties to the agreements in question (with the exception of Alpharma), including the applicant, pending before a court when those agreements were concluded. The Commission acknowledged, however, the existence of potential litigation between Lundbeck and Merck (GUK) in various parts of the contested decision (in particular in recitals 194 and 749 of the contested decision). However, ‘potential litigation’ and ‘pending litigation’ are different concepts. The Commission also acknowledged, at the hearing, that it never disputed that there was an underlying patent dispute between the parties. Accordingly, the contested decision is not vitiated by any contradiction in that it found that there was potential litigation between the parties to the agreements at issue, even though there was no pending litigation between them at the time the agreements were concluded.
201 In that respect, the reference, in recital 247 of the contested decision, to the fact that Merck (GUK) stated, following the seizure of its products in Hamburg (Germany) by the German customs authorities, on 15 November 2001, that ‘the patent litigation with Lundbeck ha[d] started today’ is not enough to support the conclusion that there was litigation pending before a national court. Moreover, the goods seized were returned two weeks later, well before the agreements at issue were concluded.
202 Furthermore, the fact that the EEA agreement contained a list of Lundbeck’s patents that Merck (GUK) was allegedly infringing does not call into question the Commission’s finding that the EEA agreement did not allow the resolution of any dispute between the parties to it, since Lundbeck was bound not to bring infringement actions only during the term of that agreement, and was free to do so upon its expiry (paragraph 1.3 of the EEA agreement). The EEA agreement merely postponed the resolution of their dispute, while eliminating any uncertainty linked to the at risk market entry of Merck (GUK) with its generic products during the period concerned.
203 Likewise, even though the UK agreement refers indirectly to the Natco citalopram, it does not specifically identify any of Lundbeck’s patents that was being infringed and does not contain any provision that would facilitate the market entry of generics upon its expiry. That agreement therefore also did not enable the resolution of the underlying patent dispute between the parties to it, but merely postponed that issue to a later date.
204 Lastly, although some clarifications were obtained regarding the patent situation during the term of the agreements at issue, those clarifications arose from the development of the Lagap litigation in the United Kingdom rather than from efforts made pursuant to, and by the parties to, those agreement. Although Merck (GUK) actually wrote to Lundbeck asking it to specify the patents, if any, it considered Merck (GUK)’s products might infringe, Lundbeck never replied to that letter, which the applicant does not dispute.
205 Accordingly, the Commission did not err in finding, in recital 758 of the contested decision inter alia, that the agreements at issue were not suitable to resolve a dispute or potential litigation between Merck (GUK) and Lundbeck.
2. The purpose of the agreements at issue
a) Lundbeck’s general strategy, intended to delay the marketing of generics
206 As regards the purpose of the agreements at issue, the applicant takes issue with the Commission for having presumed the existence of an intention on the part of the parties to the agreements reflecting a general strategy to delay the marketing of generic products, when the agreements in reality allowed the marketing of those products. Furthermore, the Commission allegedly fails to explain how Lundbeck’s perspective is decisive, or even relevant, to the assessment of whether the applicant infringed competition law, when its incentives were manifestly different. Any settlement agreement is a compromise between fundamentally diverging objectives and perspectives.
207 It must be recalled that, according to the case-law, an anti-competitive intention by the parties to an agreement is not as a matter of law a necessary factor in order to find that that agreement is anti-competitive, although it may constitute a relevant factor in that respect (paragraph 138 above).
208 In recital 803 et seq. of the contested decision, the Commission mainly examined Lundbeck’s anti-competitive intention 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).
209 As the Commission rightly found, those factors clearly show the anti-competitive intention of the parties to the agreements at issue, consisting in sharing the originator undertaking’s monopoly rent, in exchange for the exclusion of generics from the market. The fact that the agreements might have also pursued other objectives cannot call that finding into question. According to the case-law, 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 135 above, EU:C:2008:643, paragraph 21 and the case-law cited), and an agreement is not exempt from competition law merely because it concerns a patent or is intended to settle patent litigation (see, to that effect, judgment of 27 September 1988 in Bayer and Maschinenfabrik Hennecke, 65/86, ECR, EU:C:1988:448, paragraph 15).
210 Furthermore, the fact that the adoption of anti-competitive 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 49 above, EU:T:2004:220, paragraph 211, and of 8 July 2004 in Corus UK v Commission, T‑48/00, ECR, EU:T:2004:219, paragraph 73).
211 Moreover, it is doubtful that the parties sought to clarify the situation concerning Lundbeck’s patents, since the agreements at issue did not contain any clause under which Lundbeck undertook not to contest the potential entry of Merck (GUK) to the market upon the expiry of that agreement. On the contrary, under those agreements, 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 could infringe 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.
212 The applicant nevertheless submits that the Commission ought to have determined whether, on the basis of the relevant documents, there was consistent, reliable and precise evidence that Merck (GUK) had objectively a realistic prospect of success in litigation over Lundbeck’s patents rather than relying on the subjective perceptions of the parties to the agreements. Such an approach would require, however, that the Commission evaluate, as a national court would, the validity and scope of Lundbeck’s patents, even though such an examination had not been carried out at the time the agreements at issue were concluded.
213 According to the case-law, the Commission is not competent to determine the scope of a patent, although it may not refrain from all action when the scope of the patent is relevant for the purposes of determining whether there has been an infringement of Articles 101 and 102 TFEU (judgment of 25 February 1986 in Windsurfing International v Commission, 193/83, ECR, EU:C:1986:75, paragraph 26).
214 It must be found, therefore, that the Commission did not err in relying instead on the parties’ perception of their position as regards patents and of their chances of succeeding in the event of litigation at the time the agreements at issue were concluded in order to establish the existence of a restriction by object in the present case (paragraphs 76 and 77 above). That approach is entirely consistent with the case-law cited in paragraph 138 above. In addition, the Commission relied in that respect on objective elements such as documents or evidence from the parties to the agreements in tempore non suspecto. The fact that those parties may have made different statements subsequently is of little evidential value and cannot call into question the factual evidence identified by the Commission in its decision (see, to that effect, judgment of 8 July 2008 in Lafarge v Commission, T‑54/03, EU:T:2008:255, paragraph 509).
b) The relevance of the United Kingdom case-law
215 It is necessary to examine the arguments relating to the relevance of the case that gave rise to 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’), and of the Lagap litigation in order to assess the purpose of the agreements at issue, since those cases, according to the applicant, shed a different light on the objectives pursued by the parties to the agreements.
216 In the applicant’s submission, the Commission ought to have determined whether, on the basis of the relevant documents, there was consistent, reliable and precise evidence that Merck (GUK) had a realistic prospect of success in litigation concerning Lundbeck’s patents. In that respect, it takes the view that the Commission should have taken account of Merck (GUK)’s perspective, which was strongly influenced by its failure before the High Court of Justice (England & Wales), Chancery Division, in the case that gave rise to the Paroxetine judgment, just before the negotiations with Lundbeck concerning the UK agreement began.
The Paroxetine judgment
217 In the first place, the applicant submits that the Paroxetine judgment fundamentally altered the regulatory environment as regards patents in the United Kingdom, by shifting the burden of proof to the generic undertaking seeking to launch its product on the market, and that the Commission failed to take account of the relevance of that judgment in examining the purpose of the agreements at issue.
218 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 and the case-law cited) in respect of which the Court is required, in principle, to carry out a comprehensive review (paragraph 84 above).
219 In that case, 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 and 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.
220 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.
221 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 by relying on the crystallisation patent in order to block that entry.
222 In addition, it can be seen from the documents in the file that it is essentially because of the payment 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.
223 First, it can be seen from a Merck (GUK) internal e-mail 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).
224 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 generic products on 5 January 2002 if Lundbeck did not make a sufficiently attractive offer, irrespective of the Paroxetine judgment (recital 255 of the contested decision).
225 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).
226 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.
227 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.
228 In the second place, as regards the alleged failure to state reasons for the contested decision in that respect, it must be recalled that, according to the case-law, 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).
229 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 could take the view, without committing an error, that the Paroxetine case did not constitute an essential part of its analysis for the purpose of establishing a restriction of competition by object for the purpose of Article 101(1) TFEU. The various letters and communications invoked by the applicant in support of its arguments show only that, although it 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.
230 In any event, it must be pointed out that the Commission indeed took account of the Paroxetine judgment in the contested decision. It noted, in particular, in footnote No 312, that it was difficult to see how that judgment would have made Lundbeck less inclined to litigate, if that judgment was indeed more favourable to patent holders. Likewise, as regards Merck (GUK), the Commission rightly 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.
231 It follows from the foregoing that the applicant’s complaint that the Commission did not take sufficient account of the implications of the United Kingdom case-law and, in particular, of the Paroxetine judgment, must be rejected.
The Lagap litigation
232 The applicant submits that the agreements at issue limited the delays relating to its market entry, referring, in that respect, to the Lagap litigation in the United Kingdom, which was a key case for removing the obstacles linked to the Lundbeck patents. The outcome of that case was even explicitly referred to in the second extension of the UK agreement, as determinative of the duration of that agreement.
233 That argument cannot succeed however, since the initial version of the UK agreement made no reference to that litigation, which began in October 2002, after the agreement had been concluded. Moreover, it can be seen from a Lundbeck internal e-mail 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 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.
234 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 the generic citalopram 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).
235 Lastly, 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.
236 All of the applicant’s arguments seeking to call into question the Commission’s assessment, in the contested decision, of the purpose of the agreements at issue must therefore be rejected.
3. The context of the agreements at issue
237 The applicant maintains, lastly, that the Commission failed to take account of the context in which the agreements at issue were concluded when finding, inter alia, that the reverse payments made under those agreements induced Merck (GUK) to conclude those agreements, giving rise to the certainty that Merck (GUK) would not enter the market. The applicant argues that the Commission reversed the burden of proof in that respect, since it did not refute the findings in relation to the various legitimate reasons for the transfer of value which the applicant proposed in the course of the administrative procedure. The applicant submits, moreover, that the Commission disregarded the presumption of validity enjoyed by Lundbeck’s patents by characterising the agreements at issue as a restriction by object within the meaning of Article 101(1) TFEU.
a) The presumption of validity of Lundbeck’s patents
238 The applicant submits, by its second plea, that the Commission’s analysis is vitiated by a fundamental error of law, since it ignores the existence of Lundbeck’s validly granted patents. According to the applicant, since Merck (GUK) was faced with a series of presumptively valid patents, and since it had identified a risk of infringement and litigation, it was entitled and able to resolve a dispute relating to those patents by means of a settlement agreement, provided that the terms of that agreement remained within the scope of that legally approved monopoly. An assertion to the contrary would amount to denying the presumption of validity of patents and requiring generic undertakings to bring legal proceedings or to exhaust the other possibilities, irrespective of the consequences in terms of costs and risks.
239 The Commission’s interpretation of the judgment of 1 July 2010 in AstraZeneca v Commission (T‑321/05, ECR, EU:T:2010:266) in the contested decision is incorrect, since, in that judgment, the Court expressly rejected the view that a patent right must have been exercised in legal proceedings before having any effect on competitors, because competition law cannot require that competitors contravene public regulations by infringing exclusive rights. The Commission therefore erred in law in maintaining that the generic undertakings were under an obligation to initiate legal proceedings when they were faced with a validly issued patent, irrespective of the consequences in terms of risks and costs.
240 Likewise, the reference in the contested decision to the judgment of 25 February 1986 in Windsurfing International v Commission, cited in paragraph 213 above (EU:C:1986:75), is misleading, since the Commission ignores the fact that the extract from that judgment referred to in the contested decision related to surfboards which were not patent-protected and restrictions which were not covered by the subject-matter of a patent. In addition, the Court of Justice expressly acknowledged in that judgment that a patent holder may also enforce its rights by means of an agreement, without initiating judicial proceedings, provided that the agreement actually relates to the product covered by the patent, which is the case here.
241 Moreover, the Commission’s assertion that the agreements at issue, even if they fell within the scope of the patent, would infringe Article 101 TFEU because they transformed the uncertainty associated with the possible entry of the generic product to the market, including by means of patent litigation, into the certainty of no competition, disregards the true rationale of those agreements, which were intended to resolve a patent dispute. There is no ground for the conclusion that competition would take place solely by means of litigation and not by other means, such as settlement agreements, which facilitate early entry to the market.
242 The Commission disputes those arguments.
243 It must be recalled, first of all, that, although the existence of rights recognised under the industrial property legislation of a Member State is not affected by the provisions of Article 101 TFEU, 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 of 31 October 1974 in Centrafarm and de Peijper, 15/74, ECR, EU:C:1974:114, paragraphs 39 and 40).
244 Likewise, according to the case-law, although the Commission is not competent to determine the scope of a patent, it is still the case that it may not refrain from all action when the scope of the patent is relevant for the purposes of determining whether there has been an infringement of Articles 101 and 102 TFEU (judgment in Windsurfing International v Commission, cited in paragraph 213 above, 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 (judgment in Windsurfing International v Commission, cited in paragraph 213 above, EU:C:1986:75, paragraph 92).
245 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 243 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 of which they form part that the purpose of those agreements is to restrict competition.
246 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 illegality of generic products validly placed on the market which the patent holder deems to be infringing the patent. 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 50-60%.
247 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.
248 In addition, the Commission was not required to carry out its own assessment of the validity of Lundbeck’s crystallisation patent in the context of 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).
249 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).
250 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 (see inter alia recital 669 of the contested decision), is consistent with the judgment in Windsurfing International v Commission, cited in paragraph 213 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 and 102 TFEU.
251 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.
252 In view of all the foregoing, it must be held that the Commission did not disregard the presumption of validity enjoyed by Lundbeck’s patents and that it took due account of the existence of those patents and, in particular, of the crystallisation patent, as relevant contextual elements in determining the existence of a restriction of competition by object in the present case (recital 661 and 662 of the contested decision).
b) The transfer of value from Lundbeck to Merck (GUK)
253 It must be borne in mind, as a preliminary point, that the Commission took the size of the reverse payments into account as a contextual element in establishing the existence of an infringement by object for the purpose of Article 101(1) TFEU, as can be seen from recitals 661 and 662 of the contested decision in particular.
(i) The assessment of the reverse payments in the contested decision
254 The applicant submits, in the context of its third plea in law, that the Commission erred in law in finding that the payments made under the agreements at issue were determinative for the purposes of its legal assessment.
255 First, it maintains, that the Commission reversed the burden of proof by asserting that it was for Merck (GUK) to rebut the Commission’s conclusions as regards the value transfer by providing alternative, legitimate reasons.
256 Secondly, the applicant submits that the Commission failed to set out a consistent legal test for the assessment of the reverse payments in the contested decision.
257 Thirdly, the applicant maintains that the Commission committed a fundamental error of law in finding that the mere existence of a payment proved that Merck (GUK)’s decision concerning the date of the launch of generic citalopram was not based on the assessment of the strength of the patent and on the risk of infringement and the related litigation. In that regard, the applicant takes issue with the Commission for not having addressed the economic theory that it put forward, which clearly showed that the mere existence of a reverse payment does not demonstrate a restriction of competition and depends on the timetable of past and expected future events. In addition, the asymmetry of the risks between the parties as to the outcome of the litigation and its likelihood, and also the risk aversion of one or other of the parties, may explain the fact that a payment is made to overcome that asymmetry and to enable the parties to avoid lengthy proceedings that could delay the marketing of the generic product. A settlement agreement providing for such payment could therefore be beneficial for consumers where the parties would have been unable to arrive at an entry-date-only agreement.
258 Fourthly, there are fundamental differences between the case that gave rise to the BIDS judgment, cited in paragraph 135 above (EU:C:2008:643), and the agreements in the present case, since that case did not concern patent rights that enabled competitors to be legally excluded from the market. Furthermore, in that case the cartel had been concluded in order to exclude most of the operators already present on the market, and not in a situation where a generic undertaking like Merck (GUK) might hypothetically have been able to enter the market successfully.
259 The Commission disputes those arguments.
260 As a preliminary point, it must be borne in mind that, as the Commission submits, the contested decision acknowledges that the existence of a reverse payment in the context of a settlement agreement is not always problematic, particularly when that payment is linked to the strength of the patent, as perceived by each of the parties to the agreement, it is necessary in order to find an acceptable and legitimate solution in the eyes of the two parties and it is not linked to a delay in the market entry of generics (recitals 638 and 639 of the contested decision).
261 In addition, the Commission did not find, in the contested decision, that all the 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 absence of a clause allowing Merck (GUK) to launch their generic undertakings 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 object of the agreements at issue was to restrict competition, for the purpose of Article 101(1) TFEU, in the present case (see recitals 661 and 662 of the contested decision).
262 Contrary to the applicant’s assertion, the very existence of a reverse payment may constitute an indication of the weakness of a patent and of the fact that the holder of that patent is not entirely convinced of its chances of succeeding in litigation.
263 Although the position adopted by United States law cannot take precedence over that adopted by European Union law (see, to that effect, judgment of 30 September 2003 in Container Line and Others v Commission, T‑191/98 and T‑212/98 to T‑214/98, ECR, EU:T:2003:245, paragraph 1407), it must be pointed out that the Supreme Court of the United States has adopted a similar approach, in holding that the presence of such a payment could provide a workable 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, judgment of the Supreme Court of the United States of 17 June 2013 in Federal Trade Commission v. Actavis, 570 U.S. (2013)).
264 In a situation where the parties to a settlement agree that there is a genuine risk of patent infringement, it is rather surprising to see the holder of the patent at issue paying the generic undertaking to withdraw its generic product from the market. In the event that the generic undertaking has already entered the market, by infringing the patent of the originator undertaking, it would — on the contrary — be logical that the payment be made to the latter, in order to compensate the damages suffered due to the unlawful market entry of the generics.
265 It is true that, as the applicant submits, the asymmetry of risks between the generic undertaking and the patent holder may lead the latter to make a reverse payment in order to avoid all risk, even minimal, that the generic undertakings may enter the market, especially when the patented product, like Cipramil in the present case, is its flagship product, representing the majority of its turnover (recitals 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).
266 It must be recalled, however, that the fact that the adoption of anti-competitive 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 (paragraph 210 above), 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 the monopoly rent, to the detriment of consumers, as in the present case.
267 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 in the present case show that it was ready to run the risks that such market entry entailed (paragraphs 66 and 67 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.
268 Lastly, it must be found, as the Commission submits, that the existence of a reverse payment may constitute an indication that there is a restriction of competition by object, where it is apparent that that payment induced the generic undertaking not to pursue its efforts to enter the market, as in the present case.
269 Moreover, the applicant wrongly submits that the Commission reversed the burden of proof in that respect. The Commission relied on objective elements, such as the content of the meeting between Lundbeck and Merck (GUK) of 11 December 2001, in order to conclude 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 patents 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). Furthermore, 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.
270 It must be held, therefore, that the Commission fulfilled its obligations as regards the burden of proof in the present case, in accordance with the case-law cited in paragraphs 76 to 83 above.
271 Lastly, contrary to the applicant’s assertion, the Commission did not commit any error of law in relying on the BIDS judgment, cited in paragraph 135 above (EU:C:2008:643), since, as in the case that gave rise to that judgment, the agreements at issue also limited the ability of economic operators to determine autonomously the policy that they intended to pursue on the market, by preventing the normal process of competition from running its course (see, to that effect, the BIDS judgment, cited in paragraph 135 above, EU:C:2008:643, paragraphs 33 to 35).
272 It is true that, unlike the circumstances in the case that gave rise to the BIDS judgment, cited in paragraph 135 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 plea in law. Article 101 TFEU protects potential competition as well as actual competition (paragraph 70 above).
273 Furthermore, in paragraphs 84 and 85 of the judgment in CB v Commission, cited in paragraph 39 above (EU:C:2014:2204), the Court essentially highlighted the fact that the agreements referred to in the case that gave rise to the BIDS judgment, cited in paragraph 135 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 39 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.
274 In that respect, even if the paragraphs in question of the judgment in CB v Commission, cited in paragraph 39 above (EU:C:2014:2204), may be read as meaning that the 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 allowed the applicant’s market entry to be delayed, thus allowing Lundbeck to maintain high prices for Cipramil and to ensure favourable conditions for the launch of Cipralex, which was supposed to replace Cipramil in the near future (paragraph 9 above and recitals 129 to 132 of the contested decision).
275 Moreover, according to the case-law, an agreement is not exempt from competition law merely because it concerns a patent or is intended to settle patent litigation, and it 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 paragraph 209 above).
276 Accordingly, the applicant’s arguments raised in the context of the third plea in law must be rejected.
(ii) The alternative explanations put forward by the applicant concerning the existence of the reverse payments
277 The applicant submits that the Commission wrongly rejected the alternative explanations it had attempted to put forward concerning the reasons why Lundbeck had paid it EUR 19.4 million as regards the UK agreement and EUR 12 million as regards the EEA agreement (see recitals 796 to 802 of the contested decision).
The alleged objective of resolving the patent disputes
278 The applicant argues that the agreements at issue were concluded in order to resolve patent infringement issues and potential litigation.
279 In that respect, it must be recalled that, in recital 803 et seq. of the contested decision, the Commission explained that, although it was 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 upon the conclusion of those agreements, 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) had accepted to stay out of the market for a certain period, as long as the numbers ‘stacked up’ (recital 255 of the contested decision).
280 The fact that those agreements could have had the additional objective of avoiding the uncertainties of potential litigation in no way changes 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, paragraph 135 above, EU:C:2008:643, paragraph 21 and the case-law cited).
281 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 and that those agreements contain clauses going beyond what was necessary in order to enable such a settlement without infringing competition (paragraphs 154 to 205 above). In addition, it must be noted, as the Commission submits, that the UK agreement did not even specify the Lundbeck patent that Merck (GUK) allegedly infringed.
282 The applicant nevertheless considers that the conclusions in the contested decision are based on a series of selective extracts from documents cited out of context and that the Commission did not take account of other documents or information presented during the administrative procedure or proposed an erroneous interpretation of them.
283 Thus, it refers to an e-mail of 6 June 2006 drafted by the CEO of Merck Generics, from which it can be seen, according to the applicant, that Merck (GUK)’s justification for concluding the agreements at issue was that it feared that it would not prevail in the courts. The Commission took the view, however, that that e-mail had to be read in full and in context, that is to say as seeking to explain to Natco the reasons for the conclusion of an agreement as regards the EEA (footnote No 1347 of the contested decision).
284 While it is true that it is an internal e-mail, as the applicant submits, and that it mentions the fear of not prevailing in the courts, express reference is made to two options or to ‘two ways [of] look[ing] at [the situation]’ in order to explain to Natco why Merck (GUK) was preparing to sign an agreement covering the whole of the EEA and which therefore made it much more difficult for Natco to market its product in the EEA. It can also be seen from that e-mail that Merck (GUK) feared that it would have to compensate Natco and that it was seeking to transfer that cost to Lundbeck through the compensation requested under that agreement.
285 The Commission acknowledged, moreover, in recital 754 of the contested decision, that some documents suggested that Merck (GUK) had some doubts as to the non-infringing nature of its generic produced by Natco. However, the Commission rightly took the view that, overall, the evidence showed that Merck (GUK) was particularly confident in its patent position and that it thought that it was very unlikely that a court would find that Lundbeck’s patents were both valid and infringed by Merck (GUK)’s products (see inter alia recital 744 of the contested decision). Moreover, no court in the EEA had found an infringement of the crystallisation patent or had ruled on the validity of that patent at the time the agreements at issue were concluded (recital 159 of the contested decision).
286 The applicant also refers to an internal e-mail of 19 November 2001, in which a GUK patent manager considered that the process relating to the Natco citalopram ‘literally infringed’ one of Lundbeck’s process patents. The Commission examined that e-mail in recitals 248 and 754 of the contested decision, from which it can be seen that the same expert found that the patent application in question clearly lacked originality and that the patent should not, therefore, be granted. The applicant nevertheless submits that the expert in question acknowledged in that same e-mail that the patent in question covered the process used by Natco to produce the citalopram API and that it should therefore be monitored.
287 However, those factors are not sufficient to show that Merck (GUK) decided to conclude the agreements at issue and to accept the limitations on its autonomy flowing from that agreement in order to resolve a patent dispute, even a potential one, solely because of its perception of Lundbeck’s patents at that time and of the risks linked to the potential litigation it would have had to face if it entered the market, and not because of the reverse payments offered by Lundbeck. In the absence of any other convincing explanation as regards the nature and amount of those payments, the Commission could rightly conclude that they had served as compensation that led Merck (GUK) to accept limits on its commercial autonomy.
288 The applicant argues, however, that the Commission should have dealt with the decisive question of whether the risk assessment carried out by Merck (GUK) took sufficient account of the risks of infringement linked to the Lundbeck patent. It must be pointed out, however, as the Commission submits, that, even though the evidence shows that Merck (GUK) was not absolutely certain that the Natco citalopram did not infringe the Lundbeck crystallisation patent, it can be seen from the evidence cited in recital 838 of the contested decision, inter alia, that Merck (GUK) was very confident regarding the solidity of its patent position at the time the agreements at issue were concluded.
289 According to the applicant, there was, on the contrary, significant uncertainty regarding the infringing nature of the generic citalopram products, which were affected by a number of Lundbeck’s patents, since several of Lundbeck’s patent applications had not yet been granted shortly before the expiry of the original patent covering the substance.
290 It suffices to find, in that respect, that the Commission never claimed that there was no uncertainty regarding patents, but 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 agreements at issue had eliminated the uncertainty, for Merck (GUK) and Lundbeck, linked, inter alia, to the potential patent litigation, but that those undertakings had done so through anti-competitive instruments, namely agreements providing for market withdrawal 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.
291 However, the applicant disputes that a reverse payment no larger than the expected profits could have induced it to conclude the agreements at issue and submits that the Commission did not explain how that finding is sufficient to establish an infringement of competition law.
292 It must be held that the applicant’s argument on that point is based on a misreading of the contested decision.
293 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, in the present case, to establish an infringement of the provisions of the Treaty concerning free competition. 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 actual object of the reverse payment was to settle a dispute between the parties, without, however, delaying the market entry of generics.
294 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, in contrast with the agreements at issue, the payment made by Lundbeck was not made in exchange for an exclusion from the market, but was accompanied, on the contrary, by an acceptance of non-infringement and a commitment not to hinder the market entry of generics.
295 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 (paragraphs 31 and 144 above) 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 (recital 824 of the contested decision).
296 Furthermore, 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 present case. In the absence of any alternative explanation, that payment may be regarded as 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 (paragraphs 262 to 268 above) 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).
The alleged objective of compensating the costs incurred under the agreements at issue
297 The applicant submits that the Commission did not take account of the distribution costs incurred under the UK agreement, which led Merck (GUK) to conclude that it was struggling to make a profit. Likewise, as regards the EEA agreement, it did not take account of the evidence showing that the payment of EUR 12 million was intended to cover actual and expected costs and not profits.
– The UK agreement
298 As regards the UK agreement, the applicant submits that the Commission ignored the fact that the distribution arrangements under that agreement entailed significant costs for Merck (GUK), which led that undertaking to conclude, in an internal e-mail of April 2003, that it was ‘struggling to make a profit’ on the basis of the payments received under that agreement.
299 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 UK 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).
300 As regards, more specifically, 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 services provided by Merck (GUK), but rather constituted a guaranteed amount, intended to compensate Merck (GUK) for its commitment not to sell generic citalopram.
301 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 those distribution services without incurring any costs. However, the Commission took account of the fact that, under Article 6.2 of the UK agreement, Merck (GUK)’s net profits from the sale of Lundbeck’s Cipramil were capped at GBP 5 million, even if Merck (GUK) ordered more than 125 000 boxes of tablets from Lundbeck during the term of that agreement. That therefore enabled it to increase its profit margins by reducing the number of boxes distributed. 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, in an internal e-mail, that the GBP 5 million constituted net profits, without making any deductions (recitals 294 and 797 of the contested decision).
302 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 12 above) gives a total 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 (GUK) incurring any additional distribution costs.
303 The applicant nevertheless contests the Commission’s interpretation, in recital 797 of the contested decision, of the e-mail of 11 March 2003, reproduced in recital 294 of the contested decision. That internal Merck (GUK) e-mail includes, in a table, the amounts due under the agreements at issue. One of the columns, entitled ‘guaranteed profits Feb 02-Jan 03’, includes the figure 5 000. The author of that e-mail stated: ‘I have not shown what profit has been realized in each financial year but could do so if you need it’, which implies, according to the applicant, that the amount indicated cannot be regarded as guaranteed profits without making any deductions. However, as the Commission submits, that statement does not imply that the guaranteed profits, indicated as such in the e-mail, should be understood as being gross of certain costs. It appears rather that the author of that e-mail had not broken down the identified profits by financial year. In any event, even if certain costs should have been deducted, the applicant never specified the amount of those costs or to what they should have corresponded exactly, as the parties confirmed at the hearing.
304 The e-mail of April 2003, referred to in recital 295 of the contested decision, in which an employee of Merck (GUK) stated that Merck (GUK) was ‘struggling to make a profit’, must be read in its context, the CEO of Merck (GUK) having decided to slow the rate of sales of Cipramil to 150 000 boxes per month, in order to improve the gross profit margin, since the guaranteed GPB 5 million would then be divided between fewer sales (see footnote No 1465 of the contested decision). Following that change of course, Merck (GUK) first rejected Lundbeck’s offer in the negotiations for a second extension of the UK agreement, then briefly entered the market before Lundbeck made a more enticing offer.
305 It is therefore sufficiently clear from the documents in the file and from the foregoing considerations that the payments made under the UK agreement were not paid in exchange for distribution services but rather with a view to compensating the profits that Merck (GUK) estimated it could make if it marketed its generic products (paragraph 290 above) and therefore in exchange for its commitment not to enter the market with its generic products based on the Natco citalopram during the term of that agreement.
306 In that respect, it is also necessary to reject the applicant’s argument that there was no evidence to prove that Merck (GUK) obtained more revenue in the context of the UK agreement than it would have obtained if it had succeeded in litigation. That argument completely ignores the fact that the payments at issue were accompanied by a commitment, from Merck (GUK), to withdraw from the market with its generic products during the term of the agreement and to deliver those products to Lundbeck. It is true that if Merck (GUK) had succeeded in litigation against Lundbeck or if Lundbeck had dropped its claims, as in Neolab’s case (paragraph 293 above), Merck (GUK) would have undoubtedly obtained damages equivalent to the profits it would have obtained if it had immediately entered the market. However, in that case, such compensation would not have allowed the market entry of generics to be delayed, but would, on the contrary, have been accompanied by the immediate market entry of those generics (paragraph 294 above).
307 The applicant’s argument, alleging that the reverse payments made under the UK agreement were intended to compensate the distribution costs incurred under the agreement must therefore be rejected.
– The EEA agreement
308 As regards the EEA agreement, it must be recalled, first of all, that — unlike the UK agreement — it did not impose any obligation on Merck (GUK) to distribute Lundbeck’s citalopram in the form of finished products. Merck (GUK) therefore could not have incurred distribution costs under that agreement.
309 The applicant nevertheless argues that the EUR 12 million paid under the EEA agreement corresponded, first, to the costs — amounting to EUR 5 million — incurred by GUK in order to obtain the API from Natco and to compensation of EUR 2.5 million intended for NM Pharma and, secondly, to the internal costs linked to the transformation of API into finished products through Alphapharm, another subsidiary of Merck Generics, for USD 3 795 000 and USD 345 000.
310 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 compensation referred to by the applicant therefore corresponds to estimates of costs which were never actually incurred.
311 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.
312 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.
313 Accordingly, 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. The applicant’s allegations that Lundbeck’s payments constituted compensation for the additional costs that it incurred are not supported by any evidence. Consequently, 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.
314 It must therefore 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).
315 The applicant’s argument that the payment of EUR 12 million granted under the EEA agreement was intended to cover the actual and anticipated costs generated by that agreement and not profits must therefore also be rejected.
c) The applicant’s other arguments concerning the analysis of the context in which Merck (GUK) concluded the agreements at issue
316 Generally, the applicant also takes issue with the Commission for assuming that in the absence of the agreements at issue, the entry of the generics to the market would have been immediate and that those agreements allegedly impeded such entry. According to the applicant, that analysis fails to take account of the contemporaneous documents which show that there was a significant risk of patent infringement and that a launch at risk would have entailed substantial financial risks for Merck (GUK). Consequently, in the applicant’s view, the Commission did not correctly assess the overall economic and legal context in which the agreements at issue were concluded when it found that there was an infringement by object.
317 First, as regards the applicant’s allegation that the exchange of e-mails of 6 June 2002 between Merck (GUK)’s Intellectual Property Director and its CEO was dismissed as irrelevant, it must be pointed out, as the Commission submits, that, on the contrary, the content of those e-mails is examined in recitals 330 and 331 of the contested decision.
318 The Commission thus considered that the assertion that Merck (GUK) feared it would not succeed before the courts had to be read in the context of that e-mail exchange, from which it can be seen that GUK’s most senior executive responsible for intellectual property issues took the view that the amount Lundbeck proposed to pay Merck (GUK) in the draft EEA agreement was ‘far too low’, that ‘if Merck and Natco [were] Lundbeck’s worst nightmare [the latter could] afford to pay more for the advantage [it received]’, that ‘[Merck (GUK)’s] patent position [was] strong and [that] Lundbeck [had] so far not responded in the UK to [Merck (GUK)’s] letters’ and that ‘this [had to] bode well and [would] make it extremely difficult for any future attempts by Lundbeck to get an injunction in the UK’. In reply, GUK’s CEO, referred to as a ‘Merck (GUK) employee’ in the contested decision, adopted a more commercial and nuanced approach, considering that there were two ways to look at the situation, the first being that Merck (GUK) was settling because it could not succeed before the courts, in which case ‘Natco would not sell any material anyway .... at least in any injunction period’ and the second being that it was ‘logical to “look after” Natco’ in terms of compensation in the event the agreement was concluded and that the best solution would be to ‘pass this cost on to Lundbeck’ as much as possible.
319 It is therefore clear from that exchange, which was duly taken into account by the Commission in the contested decision, that Merck (GUK) would have had to face commercial uncertainty if a patent action had been brought before the courts. However, there is nothing to indicate that Merck (GUK) envisaged accepting the limitations on its conduct without the considerable sums promised by Lundbeck under the agreements at issue. On the contrary, the evidence shows that Merck (GUK) was particularly confident regarding its patent position at the time the agreements at issue were concluded and that everything was being done to ensure market entry upon the expiry of Lundbeck’s original patents (paragraph 211 above).
320 Likewise, it can be seen from the internal Merck (GUK) e-mail of 19 November 2001 that, although the author of that e-mail indicates that the Natco citalopram ‘literally infringes’ one of Lundbeck’s patents, he goes on to state that that patent must be invalid due to lack of novelty. In addition, the patent mentioned in that e-mail was not the crystallisation patent and had been granted only in Spain (footnote No 508 of the contested decision). The observation that that patent would ‘need to be monitored’ does not establish, in view of the evidence adduced by the Commission in the contested decision, that Merck (GUK) considered that Lundbeck’s patents were a problem.
321 While it is true that Merck (GUK)’s e-mail of 21 June 2001, sent to a distributor in Sweden, pre-dates the publication of Lundbeck’s application for the crystallisation patent, as the applicant submits, that e-mail nevertheless shows that, at that time, Merck (GUK) considered that it was likely to succeed in the event of litigation and that the risk of being subject to injunctions in Sweden if it marketed its product through its distributor NM Pharma was low (recitals 316 and 836 of the contested decision).
322 Moreover, as regards the threats made by Lundbeck to the generic manufacturers in 2001 following the Paroxetine judgment, according to which those manufacturers ‘must be patent infringing’ and that Lundbeck would ‘sue [them] to hell’, it suffices to point out, as the Commission noted in recital 748 of the contested decision, that, far from being intimidated by those threats, the applicant replied as follows: ‘good luck ... this does not affect us launching [our product]’.
323 Lastly, inasmuch as the applicant repeats its allegation that the Commission should have taken a position on the validity of the crystallisation patent, on whether or not the applicant’s generic products were infringing and on the uncertainty for the generic undertakings given the existence and the scope of that patent, it is appropriate to refer to the considerations set out in paragraph 288 et seq. above.
324 Secondly, inasmuch as the applicant repeats its allegation that the Commission cannot rely on the alleged belief of an undertaking concerning the outcome of hypothetical litigation in order to establish the existence of a restriction on competition by object for the purpose of Article 101(1) TFEU, it must be noted, again, that the Commission did not commit any error in relying on those contextual elements in the present case (paragraph 214 above).
325 Thirdly, the applicant complains that the Commission did not examine whether litigation was a realistic alternative, especially since that litigation would have taken place on an EEA-wide basis.
326 The Commission, in recitals 77 and 78 of the contested decision, examined the regulatory framework applicable to patents and the rules governing the burden of proof in litigation. Thus, it noted that it was for each party to prove its allegations in the event of litigation. The Commission also found that the presumption of validity enjoyed by a patent did not mean that a generic undertaking could never market its products on the market in the presence of such patents, since an MA could be granted by the competent authorities in the EEA regardless of the patent situation.
327 In addition, the Commission also established, rightly, that, contrary to the applicant’s assertions, the agreements at issue had not actually enabled the resolution of litigation, even potential litigation. Although those agreements indeed induced the applicant not to enter the market with its generic products during the term of those agreements, in exchange for payment, thus avoiding the risks of litigation, they in no way guaranteed the applicant that it would be able to enter the market without facing those risks upon the expiry of those agreements, since Lundbeck in no way undertook, under those agreements, not to bring infringement actions if Merck (GUK) entered the market after those agreements expired. Furthermore, there was no certainty that Lundbeck would have actually initiated litigation in all cases (paragraph 122 above).
328 Lastly, it must be borne in mind that, according to the case-law, 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 (paragraph 280 above).
329 In the present case, even if the applicant deemed it preferable to conclude the agreements at issue rather than entering the citalopram market ‘at risk’ with its generic product and having to face potential litigation, it is nevertheless the case that the agreements at issue, by providing for its withdrawal from the market in return for payment during a certain period, contained sufficiently serious restrictions of competition to constitute, in view of the other contextual elements taken into account by the Commission, a restriction of competition by object for the purpose of Article 101(1) TFEU.
330 Consequently, the applicant’s argument, which consists in highlighting the high costs that would have been incurred in various patent actions, must also be rejected.
331 The Commission does not dispute that, depending on the court and the type of case, the costs of patent litigation may be high. However, it rightly considered that those costs formed part of the risks inherent in any patent litigation, but that Merck (GUK) was confident in its chances of succeeding in the event of litigation, even though it was aware of the inevitable degree of risk involved in any patent litigation. The Commission therefore did not err in finding that the risks inherent in launching generic products on the market and in potential litigation did not justify the conclusion of an agreement providing for market exclusion or imposing limitations on the commercial autonomy of one party in exchange for payment, as in the present case.
332 While it is true that the Commission cannot require an undertaking to take commercial risks that it does not wish to take, the steps taken and investments made by Merck (GUK) in order to enter the market show that it was ready to accept the risks involved in such market entry in the present case (paragraphs 66 and 67 above and recital 739 et seq. of the contested decision). It is therefore erroneous to take the view, as the applicant does, that the contested decision requires generic undertakings to engage in costly litigation or to take risks that they do not wish to take, since the contested decision does not censure all types of patent settlement agreements, only those which provide for market exclusion in return for payment, as in the present case (paragraph 144 above).
333 Fourthly, the applicant submits that, if Merck (GUK) had sought to launch its generic on the market, it would have been prevented from launching its product because it would have been exposed to patent litigation for a longer period than that during which it undertook not to launch its products on the market under the agreements at issue. It refers to a table showing the probable launch date of its generic in several EEA States, based on the average duration of litigation in those States as estimated by the Commission in its Final Report in the Pharmaceutical Sector Inquiry.
334 It must be pointed out, first of all, that that argument again confuses the concepts of actual competition and potential competition.
335 In addition, that argument is based on the erroneous premiss that, if Merck (GUK) had attempted to launch its generic products on the market, it would have inevitably faced legal actions brought by Lundbeck in all the EEA States where those products were launched and Lundbeck would have inevitably succeeded, in every case, in obtaining injunctions or damages.
336 However, as the Commission found in recitals 303, 755 and 837 of the contested decision, when Merck (GUK) briefly entered the citalopram market in the United Kingdom in August 2003, and in Sweden, through its distributor NM Pharma, in May 2002, it was not sued by Lundbeck.
337 Moreover, according to Merck (GUK)’s estimates at the time, Lundbeck had little chance of succeeding in the event of litigation. In Sweden, for example, it had considered that the risk that Lundbeck would obtain an injunction was very low (recital 836 of the contested decision). Lundbeck itself stated that ‘it would be naive to think that it is not possible for producers of generic copies to produce Cipramil without breaking [its] patent’ (recital 634 of the contested decision).
338 Lastly, it must be recalled that the burden of proof rested on Lundbeck to prove that Merck (GUK)’s generic products infringed its patents and that, in the absence of such proof, Merck (GUK) could lawfully continue to sell its products, provided that it had obtained an MA for that purpose, which it had in the present case, at least as regards the United Kingdom and Sweden.
339 Fifthly, the applicant nevertheless submits that, if NM Pharma had remained on the Swedish market, it would certainly have been sued by Lundbeck and that it would have been exposed to the risk of having to pay considerable damages, capable of putting its business in jeopardy.
340 However, even if it were established that Lundbeck would inevitably have brought legal proceedings, it cannot be inferred from this, as the applicant submits, that Lundbeck would certainly have been successful in those actions, or that it would have inevitably obtained damages.
341 It is true that there was a risk, for Merck (GUK) or NM Pharma, of being exposed to such actions, but that risk formed part of the risks inherent in any launch of generic products on the market and did not justify the conclusion of an agreement providing for market exclusion in return for payment as in the present case.
342 Moreover, the figures referred to by the applicant concerning the damages that it might hypothetically have had to pay do not take account of the profits that Merck (GUK) would have made from the sale of generic citalopram, as the Commission points out. Those profits would have been even greater if Merck (GUK) had been the first generic undertaking to launch its product on the market. Thus, NM Pharma’s sales in Sweden were ‘very encouraging’ (recitals 325 and 336 of the contested decision) and Merck (GUK)’s sales in the United Kingdom, in no more than four days, between 1 and 4 August 2003, had reached GPB 3.3 million (recital 742 of the contested decision).
343 In the light of the foregoing, the applicant’s first, second and third pleas must be rejected.
III – The fifth plea in law, alleging that the Commission was wrong in concluding that the agreements at issue did not satisfy the conditions for exemption laid down in Article 101(3) TFEU
344 The applicant claims, in the alternative, that, on the assumption that the existence of a restriction by object has been established, the Commission was wrong to find that the agreements at issue did not satisfy the conditions for exemption laid down in Article 101(3) TFEU. The Commission failed to carry out a full analysis of all the agreements taken individually, but summarily rejected the applicability of Article 101(3) TFEU to all the agreements at issue, even though it recognised that an agreement may be intended to resolve a dispute between the parties amicably, with a view to avoiding further costly litigation and the risk of a potentially adverse judicial decision for either party.
345 The applicant maintains that the information which it supplied during the administrative procedure clearly permits the conclusion that the agreements at issue enabled it to launch its generic citalopram before Lundbeck’s patents had expired, thereby avoiding the risk of being ordered to pay damages and saving the costs of litigation. However, the Commission did not undertake a serious examination of those factors, within the meaning of the case-law.
346 The Commission submits that it already examined those arguments in the contested decision and that it rejected the application of Article 101(3) TFEU to the agreements at issue in recital 1212 et seq. of that decision.
347 It must be borne in mind that Article 101(3) TFEU allows undertakings to defend themselves against a finding of an infringement of Article 101(1) TFEU by demonstrating that four conditions are met:
– first, the agreement in question must contribute to improving production or distribution or to promoting technical or economic progress;
– secondly, the agreement must not impose restrictions which are not indispensable to the attainment of those objectives;
– thirdly, it must give consumers a fair share of the benefits obtained;
– fourthly, it must not allow undertakings to eliminate all competition or a substantial part of that competition in respect of the products in question.
348 Article 2 of Regulation No 1/2003 provides, as does the case-law (judgment of 6 October 2009 in GlaxoSmithKline Services and Others v Commission, C‑501/06 P, C‑513/06 P, C‑515/06 P and C‑519/06 P, ECR, 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, which means that it must demonstrate that those four conditions are satisfied as regards the infringement in question.
349 In the first place, the applicant submits that the agreements at issue allowed it to achieve other legitimate objectives.
350 First, the applicant submits that the agreements at issue enabled it to accelerate the launch of generic citalopram, and in that regard it takes issue with the way in which the Commission rejected that argument at recitals 1228 to 1230 of the contested decision, without any prospective analysis involving an examination of whether it was more likely that the agreements at issue would make it possible to obtain appreciable objective advantages or that they would not. In fact, the available data show that, if it had initiated proceedings instead of concluding the agreements at issue, it could not reasonably have expected to launch its product before the expiry of those agreements, since the average duration of patent litigation in the EEA was 2.8 years.
351 It must be noted, in that respect, as the Commission submits, that the agreements at issue rather allowed Merck (GUK)’s potentially immediate market entry in the United Kingdom, and in other EEA markets, to be delayed, and even led to NM Pharma withdrawing from the Swedish market even though it had been present on that market successfully for over five months. Furthermore, there is no certainty that Lundbeck would have brought infringement actions against Merck (GUK) if the latter had entered the market at risk, and it is even less likely that it would have been successful in all cases. Lastly, the agreements at issue do not contain any provision guaranteeing that the generic undertakings would be able to enter the market upon the expiry of those agreements.
352 Secondly, the applicant submits that the agreements at issue enabled it to avoid significant litigation costs and exposure to damages that would have jeopardised its financial viability. It asserts that it sufficiently substantiated the efficiency gains resulting from the litigation costs thus avoided, contrary to the Commission’s finding in the contested decision, and that the avoidance of potentially dangerous proceedings entails substantial efficiency gains.
353 It suffices to note, in that respect, that the Commission rejected that argument in recitals 1222 and 1223 of the contested decision, in which it found that the agreements at issue did not enable the avoidance of litigation costs, since they did not contain any undertaking from Lundbeck not to initiate such litigation after the expiry of those agreements. As the Commission submits, the fact that no proceedings were initiated by Lundbeck after the expiry of the agreements at issue was attributable, not to those agreements, but solely to the fact that other generic undertakings had already successfully entered the market.
354 Moreover, it must be pointed out that, as the Commission noted in recital 1123 of the contested decision, no party to the agreements at issue sufficiently substantiated what specific efficiency gains would have resulted from avoiding those costs, given that, according to the case-law, the efficiencies covered by Article 101(3) TFEU must be objective and not just subjective benefits for the parties such as an increase of their profits (see, to that effect, judgment of 13 July 1966 in Consten and Grundig v Commission, 56/64 and 58/64, ECR, EU:C:1966:41, p. 503).
355 Thirdly, the applicant maintains that the EEA agreement enabled it to avoid the risk of diverging court decisions within the EEA. The Commission did not respond to that argument, although it considered in its Inquiry Report on the pharmaceutical sector that that risk inevitably harmed legal certainty for the undertakings that market a given product on other European Union markets.
356 However, the applicant does not show how the agreements at issue enabled diverging court decisions to be avoided, when they contained no commitment on Lundbeck’s part not to bring proceedings after the agreements had expired. Accordingly, the figures put forward by the applicant, which report several million euros of legal costs avoided for the whole of the EEA, are irrelevant, since it does not appear that those costs would certainly have been incurred in the absence of the agreements at issue. While it is true that, ultimately, no proceedings were initiated by Lundbeck after the expiry of those agreements, that is principally because such proceedings were of no further interest, since other generic undertakings, such as Lagap in the United Kingdom, had already entered the market at that time.
357 In the second place, the applicant submits that the agreements at issue were necessary in order to yield the invoked efficiency gains.
358 First, it disputes, in that regard, the presumption on which the Commission relied in the contested decision, namely that a settlement agreement relating only to the date of entry to the market and containing no reverse payment would have enabled Merck (GUK) to launch its generic on the date in question.
359 It suffices to note that the applicant has adduced no solid evidence in that regard and that it merely refers to its previous arguments, based in particular on the economic theory that reverse payments may be justified in some cases. It does not dispute, however, that, in the present case, the agreements at issue contained considerable reverse payments which were linked to an undertaking on Merck (GUK)’s part to withdraw from the market with its generic products during the term of those agreements. The Commission was therefore not required to establish that Merck (GUK) would certainly have entered the market earlier in the absence of the agreements at issue, since it is the very fact that that possibility was eliminated that constitutes a restriction of competition in the present case (paragraph 174 above).
360 Secondly, as the Commission maintains, the applicant has not shown — on the assumption that the agreements resulted in reduced litigation costs or enabled diverging court decisions to be avoided — how those advantages would offset the resulting disadvantages for competition.
361 It must be held, as the Commission submits, that — even if the restrictions laid down in the agreements at issue had enabled the advantages alleged by the applicant to be attained — those restrictions clearly went beyond what was necessary under the second condition in Article 101(3) TFEU, given that the conclusion of other types of settlement agreement, less restrictive of competition, was possible.
362 Thirdly, the applicant has adduced no evidence showing why it was necessary to enter into those agreements in order to finance its research and development activities.
363 In the third place, in the applicant’s submission, the agreements at issue allowed consumers a fair share of the benefit, since they enabled a generic product to be placed on the market long before the expiry of the patents in force and within a shorter period than that expected for entry if litigation had taken place and, furthermore, they allowed Merck (GUK) to avoid losses and significant risks in the form of litigation costs and damages, which would have hampered its product development and launch initiatives.
364 That argument must also be rejected.
365 It is clear from the evidence in the file and, in particular, from the content of the agreements at issue, that they contained no specific date on which the generic producers could have entered the citalopram market before the expiry of Lundbeck’s patents. As the Commission found in recital 662 of the contested decision, the agreements at issue did not contain any commitment from Lundbeck to refrain from bringing infringement actions if generics entered the market after the expiry of those agreements. Those agreements therefore did not really resolve a dispute or enable a more rapid market entry of generics, as the applicant claims, but rather merely allowed Lundbeck to buy time by delaying the entry of generics into the citalopram market in exchange for the payment of considerable amounts to generic producers such as Merck (GUK).
366 Accordingly, the Commission did not err in concluding that the conditions of Article 101(3) TFEU were not met in the present case.
367 The fifth plea in law must therefore also be rejected.
IV – The sixth plea in law, alleging an infringement of the applicant’s rights of defence
368 The applicant submits, by this plea, that the contested decision infringed its rights of defence by introducing new evidence and allegations in the contested decision that were not set out in the statement of objections or the letter of facts.
369 It must be recalled that observance of the rights of the defence is a fundamental right of EU law, enshrined in Article 41(2)(a) of the Charter of Fundamental Rights of the European Union, which requires that the rights of the defence be observed in all proceedings (see judgment of 17 December 2014 in Pilkington Group and Others v Commission, T-72/09, EU:T:2014:1094, paragraph 232 and the case-law cited).
370 Respect for the rights of the defence thus requires that the undertaking concerned must have been afforded the opportunity, during the administrative procedure, to make known its views on the truth and relevance of the facts and circumstances alleged and on the documents used by the Commission to support its claim that there has been an infringement of the Treaty (see, to that effect, judgment in Aalborg Portland and Others v Commission, cited in paragraph 82 above, EU:C:2004:6, paragraph 66; see also, to that effect, judgment of 13 February 1979 in Hoffmann-La Roche v Commission, 85/76, ECR, EU:C:1979:36, paragraph 9).
371 In that connection, Article 27(1) of Regulation No 1/2003 provides (i) that the Commission is to give the undertakings or associations of undertakings which are the subject of the proceedings conducted by the Commission the opportunity to be heard on the matters to which the Commission has taken objection and (ii) that the Commission is to base its decisions only on objections on which the parties concerned have been able to comment.
372 That requirement must be interpreted in the light of the case-law to the effect that the statement of objections must set out clearly all the essential facts on which the Commission is relying at that stage of the procedure. However, that may be done summarily and the decision is not necessarily required to be a replica of the Commission’s statement of objections, since the statement of objections is a preparatory document containing assessments of fact and of law which are purely provisional in nature (see judgment in Aalborg Portland and Others v Commission, cited in paragraph 82 above, EU:C:2004:6, paragraph 67 and the case-law cited).
373 The applicant’s arguments should be examined in the light of those considerations.
374 First, the applicant argues that the Commission found for the first time in the contested decision that the reverse payments were decisive for the legal assessment of the case, irrespective of whether or not the restrictions agreed by the parties in the agreements at issue fell within the scope of the patent (recital 660 of the contested decision). In the statement of objections, on the contrary, the Commission found that the existence of payments was only one of the factors, amongst others, that contributed to the finding of a restriction by object.
375 The applicant wrongly asserts that the contested decision is no longer based on the allegation that the existence of reverse payments was only one of the factors, amongst others, that contributed to the finding of a restriction by object. That conclusion is apparent from recitals 661 and 662 as well as recitals 824 and 874 of the contested decision (paragraph 31 above). It must be held in that regard, contrary to the applicant’s assertions, that recital 480 of the statement of objections expressly stated that the existence of a reverse payment was decisive for the purposes of the legal assessment of the agreements at issue, in the same words as used in recital 660 of the contested decision. Furthermore, it is also clear from the statement of objections that limitations within the scope of the patent may also constitute restrictions by object. Thus, it is indicated, in recital 479 of the statement of objections, that agreements which, without having regard solely to the strength of the patents, merely postpone the potential generic market entry through positive inducements from the patent holder undertaking to the generic undertaking may constitute a restriction of competition by object, including, in particular, when those limitations exceed the scope of those patents.
376 Secondly, the applicant maintains that the Commission found for the first time, in footnote 1435 and recital 766 of the contested decision, that the agreements at issue and the Schweizerhall agreement ‘reinforced each other’. That new allegation was an essential element of the Commission’s finding that the agreements at issue went beyond the scope of Lundbeck’s patents since they were not restricted to the Natco product, whereas the statement of objections considered that such a restriction was a necessary consequence of the UK agreement.
377 In that respect, it must be recalled that it has been found, in the examination of the first plea in law, that the Commission committed an error of assessment in carrying out such a combined interpretation of those two agreements in order to conclude that the UK agreement contained restrictions going beyond the scope of Lundbeck’s patents (paragraphs 155 to 170 above).
378 That error of assessment has not, however, been deemed sufficient to call into question the lawfulness of the contested decision, since that decision does not make the existence of a restriction of competition by object conditional upon the presence, in the agreements at issue, of restrictions going beyond the scope of Lundbeck’s patents (paragraphs 142 and 143 above).
379 Accordingly, even if an infringement of the applicant’s rights of the defence could be established on that point, it could not have had any impact on the lawfulness of the contested decision.
380 It is settled case-law that an infringement of the rights of the defence is not capable, in itself, of affecting the validity of the contested decision as a whole where the decision is not based solely on the information in question. Instead, in such a case, the Court must disregard that information when it examines the validity of the decision (see, to that effect, judgments of 7 June 1983 in Musique Diffusion française and Others v Commission, 100/80 to 103/80, ECR, EU:C:1983:158, paragraph 30, and 14 May 1998 in Mo och Domsjö v Commission, T‑352/94, ECR, EU:T:1998:103, paragraph 74). In the present case, the reference to the Schweizerhall agreement in paragraph 178 above was made for the sake of completeness and does not constitute a necessary element for the examination of the merits of the contested decision.
381 Thirdly, the applicant submits that the possibility that Merck (GUK) could change its source of API by terminating its existing supply contract with Schweizerhall does not appear in the statement of objections. It argues that the Commission alleged for the first time, in recitals 635 and 845 of the contested decision, that Merck (GUK) could have entered the EEA markets without much delay by acquiring an existing MA or by terminating its supply agreement with Schweizerhall concerning the Natco citalopram, even though neither of those assertions was made in the statement of objections.
382 The Commission refers, in that respect, to the recitals of the statement of objections which relate to the potential and actual competition between Merck (GUK) and Lundbeck. It refers solely, however, to one paragraph in the letter of facts, from which it can be seen that, in September 2001, Merck (GUK) planned to seek a second source of citalopram, but that it had ultimately abandoned that plan.
383 It must be pointed out that that reference, in the statement of facts, does not relate specifically to the issue whether Merck (GUK) could terminate its agreement with Schweizerhall and thus enter the citalopram market with generic citalopram other than that of Natco, which is set out in recital 635 and footnote No 1562 of the contested decision.
384 It must be noted, however, that this is not an essential element of the contested decision, since it is only one of eight potential means of accessing the market, identified, in a general manner, by the Commission in recital 635 of the contested decision in order to establish the existence of potential competition between the generic undertakings and Lundbeck, and that the Commission’s conclusion on that point as regards Merck (GUK) in particular is based on a number of other pieces of evidence (paragraphs 62 to 68 above).
385 Accordingly, even if an infringement of the applicant’s rights of defence were established in that respect, it could not have any impact on the lawfulness of the contested decision (see the case-law cited in paragraph 380 above), since, even leaving aside that element, the applicant has not established that the Commission would have come to a different conclusion in the contested decision, whether in its examination in relation to potential competition or the existence of a restriction of competition by object for the purpose of Article 101(1) TFEU.
386 In the present case, the reference to the possibility of terminating the Schweizerhall agreement in paragraph 124 above was made for the sake of completeness and does not constitute an essential element for the examination of the merits of the contested decision.
387 Fourthly, the applicant submits that, whereas the statement of objections established that Merck (GUK) would in all likelihood have entered the market, the contested decision merely asserts that there was a real, concrete and realistic possibility that Merck (GUK) would try to enter the market.
388 It suffices to note, in that respect, contrary to the applicant’s assertion, that the statement of objections did not state that Merck (GUK) would have entered the market in the absence of the agreements at issue, but rather that there was a strong likelihood that Merck (GUK) would have been able to enter the market in the absence of those agreements (recitals 488, 520 and 528 of the statement of objections). That approach is therefore broadly similar to that adopted by the Commission in the contested decision, namely that Merck (GUK) had real concrete possibilities of entering several EEA markets (recitals 743 and 832 of the contested decision). While it is true that there is, in certain parts of the contested decision, a certain shift in terminology, in that it is stated that there were real concrete possibilities that Merck (GUK) would have ‘tried’ to enter the market (recital 761 of the contested decision) or that there was a considerable likelihood that Merck (GUK) would have ‘sought’ to enter the market with Natco citalopram (recital 839 of the contested decision), it is nevertheless the case that the test relating to the existence of potential competition applied by the Commission in the contested decision — which is, moreover, in accordance with the case-law (paragraphs 69 to 75 above) — is sufficiently clear from the statement of objections, with the result that the applicant was able to make known its views on that point adequately.
389 Fifthly, the applicant submits that the Commission alleged for the first time in the contested decision that the agreements at issue had an appreciable effect on competition, relying on Lundbeck’s market shares, which the applicant was unable to verify (recital 215 of the contested decision).
390 That argument must therefore be rejected at the outset as ineffective. As the Commission rightly noted in recital 724 of the contested decision, an agreement that may affect trade between Member States and that has an anti-competitive object constitutes, by its nature and independently of any concrete effect that it may have, an appreciable restriction on competition (judgment of 13 December 2012 in Expedia, C‑226/11, ECR, EU:C:2012:795, paragraph 37). The Commission was not therefore required to establish in detail, in the statement of objections or in the contested decision, the existence of an appreciable restriction on competition, since it established that the agreements at issue had an anti-competitive object and could affect trade between Member States.
391 In any event, it must be found that the statement of objections contains numerous elements relating to the effects of the agreements at issue on competition, such as, inter alia, the estimate of Lundbeck’s market share in the years following the market entry of generic citalopram (recital 109), Lundbeck’s estimate that the sales of generics would cover 60% of the citalopram market (recital 172), Lundbeck’s statement that the generic products had proved to have a significant impact on sales of branded products in the United Kingdom (recital 173), the evidence showing that the price of generic citalopram in the UK fell by almost 69 % in a few months after Lagap entered the United Kingdom market (recital 186), or the fact that the market entry of generics generally tends to strongly reduce prices (recital 48).
392 Contrary to the applicant’s assertions, the contested decision contains numerous passages which reflect those considerations (see inter alia recitals 196, 197, 209 to 213 and 726 of the contested decision). The indication of Lundbeck’s market shares in recital 215 of the contested decision, which the applicant claims it was unable to comment on, is therefore not decisive in that respect, with the result that a potential infringement of the rights of the defence on that point could not have had any impact on the contested decision (see the case-law cited in paragraph 380 above).
393 Sixthly, according to the applicant, the Commission incorrectly relied on ‘several expert opinions’ in footnote 652 of the contested decision, without providing the slightest evidence in that regard.
394 In that respect, it should be noted that reference is made, in recital 334 of the contested decision, to the fact that a Merck (GUK) manager asked, in a internal e-mail exchange, what the issues were as regards patents, stating: ‘we even have expert statements available about our process’. Merck (GUK) stated, however, in reply to the letter of facts, that those expert statements, which show the confidence it had at the time in the fact that its products were not infringing, were issued at the end of 2001, without taking account of the crystallisation patent.
395 It is difficult to see, however, how the reference to those ‘expert statements’ in footnote No 652 of the contested decision constitutes an essential element of that decision, for the purpose of the case-law cited in paragraph 372 above, as the applicant argues. It must be pointed out, as the Commission submits, that the contested decision is based on numerous other pieces of evidence which show the confidence that Merck (GUK) had, before or during the term of the agreements at issue, that its products were not infringing (see inter alia recitals 357, 754 and 838 of the contested decision). In any event, even if that were the case, as the Commission submits, that quotation was used only in the letter of facts, on which the applicant was able to make known its views.
396 Consequently, since, even if an infringement of the applicant’s rights of defence could be found, to the extent indicated in paragraphs 376 and 381 above, that infringement could not bring about the annulment of the contested decision, for the reasons stated above, the applicant’s sixth plea in law must be rejected.
V – The seventh plea in law, relating to a request for annulment or reduction of the amount of the fine
397 By its last plea in law, the applicant requests, in essence, the annulment of the contested decision, at the very least in so far as it imposes a fine on the applicant, or the reduction of that fine.
398 Before examining that plea, 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).
399 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, paragraph 398 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).
400 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).
401 As a preliminary point, it must be borne in mind that a fine of EUR 7 766 843 was imposed jointly and severally on the applicant and Merck (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).
402 First, the applicant submits that the Commission has failed to provide clear, precise and consistent evidence to support its finding of a restriction by object, and that there is therefore no basis for the imposition of a fine.
403 Secondly, it maintains that the Commission has failed to provide any clear, precise and consistent evidence to support its finding that the applicant committed the alleged infringement intentionally or negligently, within the meaning of Article 23(1) of Regulation No 1/2003.
404 Thirdly, the applicant contends that the facts at issue raise novel and complex issues for which there was no precedent at the time when the agreements at issue were concluded and that it could not have foreseen that those agreements would constitute a restriction of competition by object, since settlement agreements connected with patents are not in themselves illegal and the Commission had considered, according to a press-release of the KFST in 2004, that those agreements were in a grey area and that it was not certain that they would restrict competition. Thus, Merck (GUK)’s decision to postpone the launch of its citalopram was not anti-competitive, or at least its anti-competitive nature was not sufficiently foreseeable, and, accordingly, a fine is not justified.
405 The Commission contests those allegations.
406 First of all, in so far as the applicant reiterates, in this plea, its arguments relating to the characterisation of the agreements at issue as a restriction of competition by object, those arguments must necessarily be rejected for the same reasons as set out in the examination of the other pleas above.
407 Moreover, 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 establish that the infringement was committed intentionally or negligently, within the meaning of the first sentence of Article 23(2) of Regulation No 1/2003; what matters is to determine whether, in the light of the wording of the agreements, of their legal and economic context and of the behaviour of the parties, those parties were aware or ought to have been aware that the restrictions in those agreements were liable to infringe the rules of competition laid down in 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; 9 November 1983 in Nederlandsche BandenIndustrie-Michelin v Commission, 322/81, ECR, EU:C:1983:313 paragraph 107; and 18 June 2013 in Schenker & Co. and Others, C‑681/11, ECR, EU:C:2013:404, paragraph 37).
408 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.
409 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 e-mail 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’.
410 Furthermore, 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 150 and 151 above).
411 As regards the KFST press release, it must be noted, first of all, that it was not issued by the Commission but by a competition authority of a Member State. It must be pointed out that an undertaking which has infringed Article 101 TFEU may not escape imposition of a fine where the infringement has resulted from that undertaking erring as to the lawfulness of its conduct on account of the legal advice given by a lawyer or of the terms of a decision of a national competition authority (see judgment in Schenker & Co. and Others, cited in paragraph 407 above, EU:C:2013:404, paragraph 43).
412 Moreover, in the present case, far from raising doubts as to the applicability of Article 101 TFEU to the agreements at issue, that press release specified that the agreements at issue could influence competition if it appeared that Lundbeck had paid competitors to stay out of the market. Thus, that document clearly stated 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 undertakings, and that the Commission was therefore going to launch a broader investigation into that type of agreement in the pharmaceutical field. It is therefore clear from that press release that agreements whose purpose was to buy the market exclusion of a competitor were anti-competitive. Following its detailed investigation of the pharmaceutical sector, the Commission was able to refine its approach and fully comprehend the anti-competitive nature of certain agreements, including where those agreements involve a significant reverse payment, such as in the present case.
413 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 reverse payments — constituted an intentional or at least negligent infringement of the competition rules laid down in the treaty.
414 Lastly, as regards the exercise by the Court of its unlimited jurisdiction, it must be emphasised that, in recital 1373 of the contested decision, the Commission considered that, although Merck (GUK) had failed
to substantiate with sufficient evidence the actual distribution costs incurred as a result of the agreements at issue, it was appropriate to reduce the amount of value that Lundbeck transferred to Merck (GUK) by 10% of the turnover generated by the latter by distributing citalopram under those agreements. In reply to a question put to it by the Court, the Commission explained the method it used in that respect. Furthermore, in recital 1380 of the contested decision, the Commission decided to grant 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.
415 In those circumstances, the Court considers, in the exercise of its unlimited jurisdiction, provided for Article 31 of Regulation No 1/2003 in accordance with Article 261 TFEU, 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.
416 In the light of the foregoing, the seventh plea in law must be rejected, including as regards the exercise, by the Court, of its unlimited jurisdiction.
417 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
418 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 applicant has been unsuccessful, it must be ordered to pay the costs, in accordance with the form of order sought by the Commission.
On those grounds,
THE GENERAL COURT (Ninth Chamber)
hereby:
1) Dismisses the action;
2) Orders Generics (UK) Ltd to pay the costs.
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 fourth plea in law, alleging, in essence, that the Commission was wrong to conclude, in the contested decision, that Lundbeck and Merck (GUK) were potential competitors at the time the agreements at issue were concluded
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
II – First, second and third pleas, 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 – Examination of whether there is a restriction of competition by object within the meaning of Article 101(1) TFEU
1. The content of the agreements at issue
a) The UK agreement
b) The EEA agreement
c) The alleged absence of certain references in the agreements at issue.
2. The purpose of the agreements at issue
a) Lundbeck’s general strategy, intended to delay the marketing of generics
b) The relevance of the United Kingdom case-law
The Paroxetine judgment
The Lagap litigation
3. The context of the agreements at issue
a) The presumption of validity of Lundbeck’s patents
b) The transfer of value from Lundbeck to Merck (GUK)
(i) The assessment of the reverse payments in the contested decision
(ii) The alternative explanations put forward by the applicant concerning the existence of the reverse payments
The alleged objective of resolving the patent disputes
The alleged objective of compensating the costs incurred under the agreements at issue
– The UK agreement
– The EEA agreement
c) The applicant’s other arguments concerning the analysis of the context in which Merck (GUK) concluded the agreements at issue
III – The fifth plea in law, alleging that the Commission was wrong in concluding that the agreements at issue did not satisfy the conditions for exemption laid down in Article 101(3) TFEU
IV – The sixth plea in law, alleging an infringement of the applicant’s rights of defence
V – The seventh plea in law, relating to a request for annulment or reduction of the amount of the fine
Costs