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

JUDGMENT OF THE GENERAL COURT (Ninth Chamber)

8 September 2016 (*)

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

In Case T‑471/13,

Xellia Pharmaceuticals ApS, established in Copenhagen (Denmark),

Alpharma LLC, formerly Zoetis Products LLC, established in Florham Park, New Jersey (United States),

represented by D. Hull, Solicitor,

applicants,

v

European Commission, represented by F. Castilla Contreras and B. Mongin, acting as Agents, and by B. Rayment, Barrister,

defendant,

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

THE GENERAL COURT (Ninth Chamber),

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

Registrar: S. Spyropoulos, Administrator,

having regard to the written procedure and further to the hearing on 14 October 2015,

gives the following

Judgment

 Background to the dispute

 The companies involved in the present case

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

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

3        Alpharma Inc. was a company incorporated in the United States of America active in the pharmaceutical sector on a worldwide scale, in particular in generic medicinal products. Until December 2008 it was controlled by A.L. Industrier AS., a company governed by Norwegian law. It was subsequently bought by a United Kingdom pharmaceutical undertaking, which, in turn, was bought by a United States pharmaceutical undertaking. In the context of those restructurings, Alpharma Inc. became, first of all, in April 2010, Alpharma LLC, and then, on 15 April 2013, Zoetis Products LLC (‘Zoetis’) and, finally, on 6 July 2015, it returned to being Alpharma LLC.

4        Alpharma Inc. controlled all the shares in Alpharma ApS, a company governed by Danish law, which had a number of subsidiaries in the European Economic Area (EEA) (hereinafter referred to, overall, as the ‘Alpharma group’). Following a number of company restructurings, on 31 March 2008 Alpharma ApS became Axellia Pharmaceuticals ApS, renamed Xellia Pharmaceuticals ApS (‘Xellia’) in 2010.

 The relevant product and the applicable patents

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

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

7        As regards the EEA, the protection afforded by the original patents and, where appropriate, the supplementary protection certificates (‘SPCs’) provided for in Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ 1992 L 182, p. 1), expired between 1994 (as regards Germany) and 2003 (as regards Austria). In particular, in the case of the United Kingdom, the original patents expired in January 2002.

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

9        First, on 13 March 2000 Lundbeck filed a patent application with the Danish authorities relating to a process for the production of citalopram which envisaged a method of purification of the salts used by means of crystallisation. Similar applications were filed in other EEA countries and also with the WIPO and the EPO. Lundbeck obtained patents protecting the crystallisation process (‘the crystallisation patents’) in a number of Member States during the first half of 2002, in particular on 30 January 2002 in the case of the United Kingdom and on 11 February 2002 in the case of Denmark. The EPO granted a crystallisation patent on 4 September 2002. In addition, in the Netherlands, Lundbeck had already obtained, on 6 November 2000, a utility model for that process (‘Lundbeck’s utility model’), that is to say, a patent valid for six years, granted without a prior examination.

10      Secondly, on 12 March 2001, Lundbeck filed a patent application with the United Kingdom authorities for a citalopram production process using a salt purification method by film distillation. The United Kingdom authorities granted Lundbeck a patent for that film distillation method on 3 October 2001 (‘the film distillation patent’). However, that patent was revoked on 23 June 2004 for lack of novelty by comparison with another Lundbeck patent.

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

 Agreement entered into by Lundbeck with the Alpharma group and other matters relating to the background

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

13      The relevant agreement for the purposes of the present case (‘the agreement at issue’) was concluded between Lundbeck and Alpharma ApS on 22 February 2002 and covered the period running from that date until 30 June 2003 (‘the relevant period’).

14      Before concluding that agreement, in January 2002 the Alpharma group had bought from Alfred E. Tiefenbacher GmbH & Co. (‘Tiefenbacher’) a stock of generic citalopram tablets produced on the basis of the API of the Indian company Cipla and had ordered further supplies.

15      As regards the preamble to the agreement at issue (‘the preamble’), it should be observed, in particular, that:

–        the first recital states that ‘Lundbeck owns intellectual property rights including, in particular, patent rights relating to the manufacture of the [API] “Citalopram” [(written with an upper case “C” throughout the agreement)], including the patents set out in Appendix A’ to that agreement (‘Appendix A’);

–        the second recital states that Lundbeck produces and sells pharmaceutical products containing ‘Citalopram’ in all Member States and also in Norway and Switzerland, those countries being together defined as ‘the Territory’;

–        the third and fourth recitals mention that the Alpharma group has produced or purchased pharmaceutical products containing ‘Citalopram’ in ‘the Territory’, without Lundbeck’s consent;

–        the fifth and sixth recitals state that the Alpharma group’s products have been subjected to laboratory analyses by Lundbeck, the results of which gave Lundbeck substantial reason to believe that the production methods used to produce those products infringed its intellectual property rights;

–        the seventh recital recalls that, on 31 January 2002, Lundbeck filed a lawsuit with a United Kingdom court (‘the UK infringement action’) seeking an injunction ‘against [the] Alpharma [group’s] sale of products containing Citalopram for infringing Lundbeck’s intellectual property rights’;

–        the eighth recital states that the Alpharma group acknowledges that Lundbeck’s findings are correct and undertakes to refrain from marketing ‘such products’;

–        the ninth and tenth recitals state that Lundbeck:

–        ‘has agreed to compensate [the] Alpharma [group] in order for Lundbeck to avoid ... patent litigation’, the outcome of which cannot be predicted with absolute certainty and which would be costly and time-consuming;

–        ‘in order to settle the dispute, [has] agreed to purchase all of [the] Alpharma [group’s] stock of products containing Citalopram and to compensate [it] for such products’.

16      As regards the body of the agreement at issue, it should be observed, in particular, that:

–        Article 1.1 (‘Article 1.1’) stipulates that the Alpharma group and its ‘Affiliates’ ‘shall cancel, cease and desist from any importation, … production, … or sale of pharmaceutical products containing Citalopram in the Territory … during [the relevant period]’ and that Lundbeck is to withdraw the UK infringement action;

–        Article 1.1 also specifies that it is not to apply to ‘any product containing escitalopram’;

–        Article 1.2 provides that ‘in the event of any breach of the obligation set forth in Article 1.1 or at the request of Lundbeck, [the] Alpharma [group] … will voluntarily submit to an interim injunction by any competent court in any applicable country in the Territory’ and that Lundbeck is to be entitled to obtain such injunction without providing any kind of security;

–        Article 1.3 states that, as compensation for the obligations set out in that agreement and in order to avoid the costs and time of litigation, Lundbeck is to pay to the Alpharma group the sum of USD 12 million, of which USD 11 million is to be for the Alpharma group’s products containing ‘Citalopram’, in three instalments of USD 4 million, to be paid on 31 March 2002, 31 December 2002 and 30 June 2003 respectively;

–        Article 2.2 establishes that, no later than 31 March 2002, the Alpharma group is to deliver to Lundbeck its entire current stock of products containing ‘Citalopram’, namely the 9.4 million tablets already in its possession at the time of conclusion of the agreement at issue and the 16 million tablets which it had ordered.

17      Appendix A contains a list of 28 intellectual property rights applications lodged by Lundbeck before the signature of the agreement at issue, including nine which had already been granted by that date. Those intellectual property rights related to the processes used to produce the citalopram API covered by the crystallisation and film distillation patents.

18      Furthermore, it should be noted that on 2 May 2002 a United Kingdom court granted a consent order staying all proceedings in the UK infringement action because of the conclusion of an agreement between Lundbeck and, among others, the Alpharma group, under which the latter would ‘cancel, cease and desist from all importation ... production ... or sale, in [the Member States], Norway and Switzerland (“the Relevant Territories”) of pharmaceutical products containing citalopram manufactured using processes claimed in [the crystallisation and film distillation patents granted by the United Kingdom authorities] or any equivalent patent granted or applied for in relation to the Relevant Territories … until 30 June 2003’ (‘the consent order of 2 May 2002’).

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

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

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

21      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.

22      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.

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

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

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

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

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

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

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

30      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’).

 Contested decision

31      By the contested decision, the Commission considered that the agreement at issue, and likewise 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, committed by Lundbeck and also by Alpharma ApS, Alpharma Inc. and A.L. Industrier (Article 1(3) of the contested decision).

32      As is apparent from the summary set out in recital 1087 of the contested decision, the Commission relied, in particular, when making that finding, on the following factors:

–        at the time when they concluded the agreement at issue, Lundbeck and the Alpharma group were at least potential competitors in a number of EEA countries;

–        under that agreement, Lundbeck transferred significant value to the Alpharma group;

–        that transfer of value was linked to the Alpharma group’s acceptance of the limitations on market entry contained in that agreement, and in particular to the Alpharma group’s commitment not to sell any generic citalopram in the EEA during the relevant period;

–        that transferred value corresponded approximately to the profit that the Alpharma group could have made if it had successfully entered the market;

–        Lundbeck would not have been able to obtain those limitations through enforcement of the crystallisation and film distillation patents (‘Lundbeck’s new patents’), since the obligations placed on the Alpharma group under the agreement at issue went beyond the rights granted to holders of process patents;

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

33      The Commission also imposed fines on all the parties to the agreements in question. To that end, it applied the Guidelines on the method of setting fines imposed pursuant to Article 23(2)(a) of Regulation No 1/2003 (OJ 2006 C 210, p. 2) (‘the 2006 Guidelines’). Although, in the case of Lundbeck, the Commission followed the general methodology described in the 2006 Guidelines, based on the value of sales of the product achieved by that undertaking (recitals 1316 to 1358 of the contested decision), in the case of the other parties to the agreements in question, however, namely the generic undertakings, it made use of the possibility, provided for in point 37 of those guidelines, to depart from that methodology, in view of the particularities of the case so far as those parties were concerned (recital 1359 of the contested decision).

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

35      As regards the Alpharma group, the Commission considered that the sums which Lundbeck had paid to it amounted to USD 11.1 million, equivalent to EUR 11.7 million, according to the average exchange rate in 2002. That amount consisted of (i) USD 10.1 million for the purchase of the Alpharma group’s stock of citalopram, allowing for a reduction of USD 900 000 applied to the instalment paid by Lundbeck on 31 December 2002 (see the fourth indent of paragraph 16 above) on the ground that the number of tablets received had been lower than the agreed level, and (ii) USD 1 million in respect of the litigation costs saved as a result of the conclusion of the agreement at issue (recitals 545, 547, 1071 and 1374 and footnote No 1867 of the contested decision).

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

37      Last, the Commission applied the second subparagraph of Article 23(2) of Regulation No 1/2003 (which provides that, for each undertaking participating in an infringement, the fine is not to exceed 10% of its total turnover in the preceding business year) separately to Xellia, Zoetis and A.L. Industrier, since those companies no longer belonged to the same undertaking at the time of adoption of the contested decision (recital 1384 of the contested decision). In the case of A.L. Industrier, the Commission took into account the turnover achieved in 2011, and not that achieved in 2012, since it considered that the figures for 2012 did not relate to a year of normal economic activity (recitals 1386 and 1387 of the contested decision).

38      On the basis of those considerations, the Commission imposed a fine of EUR 10 530 000 jointly and severally on Xellia and Zoetis, while the joint and several liability of A.L. Industrier was limited to an amount of EUR 43 216 (recital 1396 and Article 2(3) of the contested decision).

 Procedure and forms of order sought

39      By application lodged at the Court Registry on 30 August 2013, Xellia and Zoetis (see paragraphs 3 and 4 above), brought the present action.

40      The written part of the procedure was closed on 18 July 2014.

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

42      The parties responded to that request within the prescribed period.

43      On a proposal from the Judge-Rapporteur, the Court (Ninth Chamber) decided to open the oral part of the procedure and, by way of measures of organisation of procedure as provided for in Article 89 of its Rules of Procedure, put a number of questions to the parties, requesting them to answer in writing: the parties complied with that request within the prescribed period.

44      The parties presented oral argument and replied to the questions put by the Court at the hearing on 14 October 2015.

45      The applicants, Xellia and Alpharma LLC, claim that the Court should, in essence:

–        primarily annul Articles 1 to 3 of the contested decision in so far as they concern the applicants;

–        in the alternative, annul in part Article 1 of the contested decision, in so far as it concerns the applicants, and reduce the fine imposed on them in Article 2(3) of that decision;

–        order the Commission to pay the costs.

46      The Commission contends that the Court should:

–        dismiss the application;

–        order the applicants to pay the costs.

 Law

47      In support of their action, the applicants raise eight pleas in law, alleging, in essence, first, a manifest error of assessment as regards the Commission’s interpretation of the scope of the agreement at issue; second, errors of law and of assessment as regards the characterisation of the Alpharma group as a potential competitor to Lundbeck; third, a manifest error of assessment in the characterisation of the agreement at issue as a restriction of competition by object; fourth, an error of law as regards the finding of the existence of such a restriction when that agreement reflects the exclusionary scope of Lundbeck’s patents; fifth, breach of the rights of the defence; sixth, breach of the principle of non-discrimination owing to the fact that Zoetis is an addressee of the contested decision; seventh, errors affecting the calculation of the amount of the fine imposed on the applicants; and, eighth, a manifest error of assessment in connection with the maximum amount of the fine in respect of which A.L. Industrier is jointly and severally liable.

48      It is appropriate to consider (i) the second plea in law, then (ii) the first plea in law and, finally, (iii) the other pleas in law in the order used by the applicants.

 The second plea in law, alleging errors of law and of assessment as regards the characterisation of the Alpharma group as a potential competitor

49      The applicants’ second plea, which relates to potential competition, is divided into two parts, the first concerning the legal standard to be applied and the second concerning whether the Commission proved to the requisite standard that such competition existed in the present case.

50      Before examining the parts of the plea in detail, it is necessary briefly to recall the analysis of potential competition made in the contested decision, in particular as regards the Alpharma group, and to make a number of preliminary observations concerning the case-law relating to that competition, to the burden of proof and to the extent of the Court’s review.

 Analysis relating to potential competition in the contested decision

51      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.

52      The first phase may begin several years before the impending expiry of the patent on an API, when generic producers that want to launch a generic version of the medicinal product concerned begin developing viable processes leading to a product that meets regulatory requirements. Next, in the second phase, in order to prepare for actual market entry, a generic undertaking must apply for marketing authorisations (‘MAs’) for the purposes 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), 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.

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

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

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

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

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

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

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

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

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

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

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

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

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

58      As regards, in particular, the examination of competition between Lundbeck and the Alpharma group at the time of conclusion of the agreement at issue, the Commission, in recitals 1016 to 1039 of the contested decision, noted, inter alia, that the Alpharma group:

–        had already entered into an agreement with Tiefenbacher, under which it could purchase generic citalopram produced by the Indian companies, Cipla or Matrix, and use the MAs that Tiefenbacher already held;

–        had obtained MAs in the Netherlands, Finland, Denmark and Sweden and expected to receive one imminently in the United Kingdom as well;

–        had 9.4 million generic citalopram tablets in stock, produced using Cipla’s process, and had ordered 16 million more;

–        had published sales prices in the United Kingdom;

–        was planning to enter the market in a number of EEA countries within a period of two to six weeks;

–        had reached the conclusion that the process used by Cipla to produce citalopram infringed the crystallisation patent but considered that it had a reasonable chance of avoiding an injunction blocking its market entry and of securing invalidation of that patent;

–        had the option of switching to citalopram produced by Matrix, which was using a process that was considered not to infringe Lundbeck’s new patents.

 Applicable principles and case-law

–       Potential competition

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

60      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 59 above, EU:T:2012:332, paragraph 85).

61      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 the undertaking 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 59 above, EU:T:2012:332, paragraph 86 and the case-law cited).

62      It necessarily follows that, while the intention of an undertaking to enter a market may be of relevance in order to determine whether it can be considered to be a potential competitor in that market, nonetheless the essential factor on which such a description must be based is whether it has the ability to enter that market (see judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 59 above, EU:T:2012:332, paragraph 87 and the case-law cited).

63      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 60 above, EU:T:2011:181, paragraph 169).

64      Moreover, the case-law has also stated 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).

65      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 59 above, EU:T:2012:332, paragraphs 106 and 114).

–       The burden of proof

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

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

68      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 66 above, EU:T:2013:188, paragraph 93 and the case-law cited).

69      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 66 above, EU:T:2013:188, paragraph 95 and the case-law cited).

70      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 66 above, EU:T:2013:188, paragraph 96 and the case-law cited).

71      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 66 above, EU:T:2013:188, paragraph 97 and the case-law cited).

72      Lastly, it must be pointed out that, when the Commission establishes that the undertaking in question has participated in an anticompetitive measure, it is for that undertaking to provide, using not only documents that were not disclosed but also all the means at its disposal, a different explanation for its conduct (see, to that effect, judgment of 7 January 2004 in Aalborg Portland and Others v Commission, C‑204/00 P, C‑205/00 P, C‑211/00 P, C‑213/00 P, C‑217/00 P and C‑219/00 P, ECR, EU:C:2004:6, paragraphs 79 and 132).

73      Where the Commission has documentary evidence of an anticompetitive practice, it is not sufficient for the undertakings concerned to prove circumstances which cast the facts established by the Commission in a different light and thus allow another explanation of the facts to be substituted for the one adopted by the Commission. In the presence of documentary evidence, the burden is on those undertakings not merely to submit another explanation for the facts found by the Commission but to challenge the existence of those facts established on the basis of the documents produced by the Commission (see, to that effect, judgment in CISAC v Commission, cited in paragraph 66 above, EU:T:2013:188, paragraph 99 and the case-law cited).

–       The extent of the Court’s review

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

75      Those considerations serve as the reference framework for examination of the two parts that make up the present plea.

 The first part

76      By the first part of the second plea, the applicants maintain that the Commission applied the wrong legal test when establishing whether the Alpharma group was a potential competitor of Lundbeck. In that context, they observe that the Commission merely asked itself whether, at the time of the conclusion of the agreement at issue, market entry was, for the Alpharma group, a plausible assumption, on the basis, in particular, of Lundbeck’s subjective view, while it ought to have adduced proof that such entry was a real concrete possibility, corresponding to a viable economic strategy. According to the applicants, the Commission should, to that end, have conducted a detailed analysis of the costs of the Alpharma group, including any damages that might have to be paid in the event of infringement, and of its profits.

77      The Commission does not deny that it was required to prove that the Alpharma group had a real concrete possibility of entering the market and that there had to be a viable economic strategy, but it maintains that that is not the same as its being required to demonstrate, following an analysis of, in particular, the potential costs of such entry, that the entry would be bound to succeed.

78      The Court notes that the parties do not really disagree over the majority of the principles that follow from the case-law referred to in paragraphs 59 to 65 above.

79      The issues in dispute concern the importance of Lundbeck’s perception of the Alpharma group’s role and the meaning of the expressions ‘real concrete possibilities’ and ‘economically viable strategy’.

80      As regards the first issue, the Court confirms the Commission’s opinion that that perception is important, which is consonant with the case-law referred to in paragraphs 64 and 65 above. That is not, however, the only factor to be taken into account. In addition, that perception must be demonstrated on the basis of specific evidence.

81      As regards the second issue, it should be observed that, as the Commission correctly maintains, the two expressions in question have, in essence, the same meaning. In addition, the Commission is also correct in its contention that, in using those expressions, the case-law does not require that, for an undertaking to be characterised as a potential competitor, it is necessary to show that its market entry, were it to take place, would be bound to succeed. The existence of risk and uncertainty is inherent in the fact that the competition in question is potential. However, the Commission is required to show, again by means of specific evidence, that there is a real concrete possibility of the undertaking concerned entering the market.

82      The applicants are thus incorrect in their assertion that the Commission applied the wrong legal test. The question whether the contested decision is supported by sufficient evidence in that regard forms the subject matter of the second part of this plea.

 The second part

83      In the context of the second part of this plea, the applicants dispute the proposition in recital 1035 of the contested decision that, at the time when the agreement at issue was concluded, the Alpharma group had the option, inter alia, of entering the market with the citalopram tablets which it had already received or ordered from Tiefenbacher and the option of launching some months later with tablets using the Matrix API.

84      The Commission disputes the applicants’ arguments.

–       The Alpharma group’s ability to enter the market with the tablets that it had already received or ordered

85      The Court observes that, in recital 1027 of the contested decision, the Commission reproduced the text of an email, dated 19 February 2002, from a managing director of the Alpharma group responsible for the relevant dossier (‘the email of 19 February 2002’), who, three days before the agreement at issue was concluded:

–        recalled that the group planned to launch citalopram produced using Cipla’s process in a number of Member States;

–        noted that that process was now considered to infringe Lundbeck’s new patents;

–        referred to the preparation of a defence in that regard, entailing a claim of invalidity against those patents, in respect of which the chances of success were reasonable;

–        mentioned the costs related to that claim, pointing out that, if the claim was successful, it would be possible to recover a substantial part of the costs from Lundbeck which would, however, itself be able to claim substantial damages if it won the case;

–        mentioned the possibility of using citalopram produced using the Matrix process, which he regarded as not giving rise to problems with regard to Lundbeck’s new patents, while admitting that a change of API supplier would delay market entry by three to four months and reduce by USD 2 million profits connected with that entry, whose net present value was estimated to be USD 10 million;

–        recommended that efforts should be made to conclude an agreement with Lundbeck if a reasonable settlement could be achieved, serving the legal and commercial interests of the Alpharma group.

86      In recital 1035 of the contested decision, the Commission pointed out that, according to the email of 19 February 2002, instead of concluding the agreement at issue, the Alpharma group could have entered the market with the citalopram tablets that it had already received or ordered, produced using the Cipla process, and could have claimed that the crystallisation patent infringed by that process was invalid, according to the information available to the Alpharma group and Lundbeck at that time.

87      The applicants argue that that was not an economically viable strategy.

88      In that regard, it should be observed that the applicants themselves acknowledge that the Alpharma group considered that its chances of invalidating the crystallisation patent were reasonable, as follows in particular from the email of 19 February 2002.

89      Furthermore, the parties are, in essence, in agreement on the fact that Lundbeck had a similar point of view. That is consistent with a number of items of evidence referred to in the contested decision, from which it is apparent that Lundbeck acknowledged that the likelihood of that patent being held invalid was estimated at between 50 and 60% (see, for example, recitals 157, 627, 669 and 745 and footnote No 322 of the contested decision).

90      It is therefore necessary to establish whether, from the perspective of the Alpharma group, the fact that it had a reasonable chance of that kind was sufficient to encourage it to continue with its plan, as presented inter alia in the email of 19 February 2002, to enter the market with the citalopram tablets that it had already received or ordered.

91      The point must be made in that regard that, until the conclusion of the agreement at issue, the Alpharma group had taken numerous steps and made significant investments for the purpose of entering the market.

92      Indeed, as can be seen inter alia from recitals 476, 485, 490, 516 and 1017 of the contested decision, which refer to or cite a number of documents on the Commission’s case file, the Alpharma group, at the time when the agreement at issue was concluded:

–        had already concluded a contract with Tiefenbacher, dated 25 June 2001, for the supply of citalopram produced using the Cipla or the Matrix processes;

–        could, pursuant to that contract and to a previous contract between the same parties, of 31 July 2000, obtain an MA in the Netherlands, on the basis of the MA issued to Tiefenbacher on 31 August 2001 by the authorities of that Member State, and could, pursuant to the mutual recognition procedure laid down in Directive 2001/83, obtain MAs in other EEA countries;

–        had already 9.4 million citalopram tablets in stock and 16 million more on order;

–        had already obtained MAs in the Netherlands, Finland, Denmark and Sweden and had received, on 9 January 2002, assurances that it would obtain one in the United Kingdom in the very near future;

–        had already published a list of prices for its citalopram in the United Kingdom.

93      Those findings are not challenged by the applicants.

94      In the first place, the applicants assert, however, that the Commission did not take account of the damages which the Alpharma group would have had to pay Lundbeck in the event that it was unsuccessful in a probable lawsuit, of the related litigation costs or of the risk that it would have to indemnify its downstream customers. They argue that the amount arising as a result of all those factors would greatly exceed the profits which the Alpharma group expected to make in the event of market entry.

95      In that regard, the Court observes, first, that the applicants base their estimate relating to the aforementioned damages on an internal document dating from 2003 and claim that it is the maximum amounts set out therein, namely USD 21.7 million, which must be taken into account rather than the likely amounts which are also included in that document, since, if the Alpharma group had entered the market in February 2002, it would have been the first generic undertaking to do so and would have thus caused greater damage to Lundbeck than the damage considered likely in 2003.

96      As the Commission rightly points out, there is nothing to suggest that the data set out in that document, which concern a launch of generic citalopram in 2004, can be transposed to the situation as it stood in 2002. Furthermore, it has not been proved that the Alpharma group was, in 2002, the only generic undertaking in a position to enter the market. Similarly, that document specifies that, in five of the seven countries concerned, the risk of the Alpharma group losing a case was low, while, in the two other countries concerned, it was medium. Thus, the applicants are not justified in taking into account the full amount of USD 21.7 million or even in applying to that amount a single coefficient of 50% based on their probable chances in litigation. Moreover, whilst it is true that Lundbeck, in a document dating from 2003 to which the applicants refer, estimated that it could obtain damages ranging from EUR 20 to 55 million from the generic undertakings if it chose to bring actions against them, it must be observed that those figures concern all the undertakings with which Lundbeck could have been in dispute and not solely the Alpharma group.

97      Therefore, the documents at issue do not demonstrate that the Alpharma group, because of the risk that it would have to pay Lundbeck damages, did not have a real concrete possibility of entering the market with the tablets that it had already received or ordered.

98      Secondly, the applicants maintain that the contested decision failed to analyse litigation costs sufficiently, as the Commission took into consideration only the sum of USD 1 million mentioned in that respect in the agreement at issue.

99      On that point, it should be noted that the applicants have failed to produce any documents which permit the inference that, before concluding the agreement at issue, the Alpharma group had made estimates of those costs which would have led it to abandon its planned market entry despite the fact that, according to the email of 19 February 2002, the existence of costs related to a possible lawsuit with Lundbeck was not, at that time, regarded as a factor rendering the option of market entry economically non-viable.

100    In addition, since the parties to the agreement at issue themselves assessed the costs of any litigation that might arise between them at USD 1 million, the Commission was not required to investigate the matter further. In that regard, it must be observed that the wording of Article 1.3 of the agreement at issue does not make clear whether that amount was intended to relate solely to the costs associated with the UK infringement action, which was already pending, or to other possible lawsuits as well. In any event, it was not essential for the Alpharma group to effect parallel market entry in a number of countries; it could instead have focused its efforts on a limited number of countries, which would have allowed it to avoid multiple lawsuits. Moreover, the internal email cited in recital 508 of the contested decision shows that this possibility was envisaged by the Alpharma group (through the phrase ‘our major efforts should be focused on [the] UK and the Nordic countries’).

101    It should also be noted that, according to an internal email of the Alpharma group of 8 February 2002, which is included in the Commission’s case file and has been produced before the Court, the group was contemplating splitting with Tiefenbacher the costs relating to possible litigation with Lundbeck. In that regard, the applicants have not substantiated their claim that Tiefenbacher might not have been receptive to such a split.

102    Accordingly, the applicants’ present arguments are not capable of establishing that the Commission made an error in its assessment of potential competition.

103    Thirdly, the applicants mention the fact that the Commission failed to take due account of the risk that the Alpharma group would have to indemnify its downstream customers in the event of Lundbeck bringing actions against them. They submit that that risk dissuaded the group from entering the market.

104    In this connection, recitals 497 and 508 of the contested decision state that Lundbeck had in fact threatened wholesalers and pharmacies in the Netherlands. However, the Alpharma group email of 23 January 2002, on which the applicants rely, does not show that those threats had definitively convinced the Alpharma group to delay the projected launch of generic citalopram on the Netherlands market. Rather, the email of 19 February 2002 includes the Netherlands amongst the countries whose markets the Alpharma group had planned to enter within the following two to six weeks.

105    That information is also to be found in an internal email of 14 February 2002 (‘the email of 14 February 2002’), which is quoted in recital 516 of the contested decision.

106    Furthermore, although it appears from an email from an unidentified person to a generic undertaking other than the Alpharma group, which has been produced by the applicants, that the Netherlands wholesalers and pharmacies were seeking ‘protection’ from the generic undertakings against possible lawsuits brought by Lundbeck, that does not mean that the Alpharma group was persuaded that a request of that kind from the wholesalers and pharmacies was well founded.

107    Consequently, nor is this argument of the applicants capable of establishing that the Commission made an error in its assessment of potential competition.

108    In any event, it follows inter alia from the emails of 14 and 19 February 2002 that the Alpharma group, whilst aware of the risks that market entry might entail, would not necessarily have abandoned its plans if it had not been able to conclude a sufficiently advantageous agreement with Lundbeck. The fact that, until the conclusion of the agreement at issue, market entry remained a real concrete possibility for the Alpharma group is subsequently confirmed by an email from a Vice-President of Alpharma Inc., dated 19 February 2002 (‘the Vice-President’s email’), which was included in the Commission’s case file and has been produced before the Court. The author of the email explains that, until an agreement with Lundbeck was signed, the Alpharma group’s outside intellectual property counsel was not to be informed of the on-going negotiations, since, in the event of the group having to respond to an injunction, it was necessary for it to be prepared. The fact that the Alpharma group was preparing itself for the eventuality of its being the target of an injunction means that, for the group, market entry was a real concrete possibility in the event of a failure to conclude a sufficiently advantageous agreement with Lundbeck.

109    That finding is not called into question by the statement made to the press on 29 May 2002 by an Alpharma group executive (‘the statement of 29 May 2002’), relied on by the applicants, according to which that person thought that the legal situation was unclear and that the risk outweighed any potential profit.

110    That statement in fact describes the situation as it was several months after the agreement at issue was concluded.

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

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

113    The evidential value of the statement put forward by the applicants is therefore reduced.

114    Moreover, that evidential value is further diminished owing to the fact that the Alpharma group, which had accepted in secret the restrictions on its commercial autonomy arising from the agreement at issue against the payments provided for therein, had to justify, if only to its potential customers, the changes to the plans it had previously announced.

115    It follows that the applicants’ arguments summarised in paragraph 94 above must be rejected.

116    In the second place, the applicants maintain that, although the Alpharma group had taken steps and made investments with the aim of entering the market, its perspective had changed dramatically over the period immediately prior to the conclusion of the agreement at issue because of the discovery of matters which allegedly are of fundamental importance and were not previously known about or occurred just before that agreement was concluded. The matters in question are the fact that the Cipla process infringed Lundbeck’s utility model (see paragraph 9 above), Tiefenbacher’s obtaining of information, the grant of the crystallisation patent in the United Kingdom and the advice of outside counsel.

117    In that regard, first, it should be recalled that, as follows from recital 477 of the contested decision, Lundbeck, on 11 January 2001, sent the Alpharma group a warning letter informing it that the group’s activities relating to citalopram might infringe Lundbeck’s intellectual property rights in respect of processes for obtaining that API, including its utility model.

118    It cannot therefore be considered that the Alpharma group found out about the existence of that utility model only in 2002.

119    Secondly, it is certainly noteworthy that the fact that Lundbeck obtained, on 30 January 2002, the crystallisation patent in the United Kingdom came as a surprise to the Alpharma group since it was not expecting the patent application filed by Lundbeck on 12 March 2001 to be granted, as can be seen from a statement made by the director of the Alpharma group responsible inter alia for intellectual property (‘the IP director’) produced by the applicants.

120    Similarly, whilst it follows from the email of 17 September 2001 — cited in part in recital 482 of the contested decision and produced in full before the Court — that Tiefenbacher had reassured the Alpharma group that the Cipla process did not infringe Lundbeck’s new patents, the group subsequently came to the conclusion that that process infringed the crystallisation patent, as is apparent inter alia from the email of 19 February 2002.

121    Accordingly, the applicants are not incorrect in their assertion that, in January and February 2002, the Alpharma group had received new information and analysis which had not hitherto been available to it.

122    It is also the case that, in that period, the Alpharma group sought advice from at least one outside counsel. It follows from the only advisory opinion included in the case file, dated 19 February 2002, that the Cipla process was considered to infringe the crystallisation patent. Nevertheless, as the applicants admit, that advice indicates, in essence, that there was a reasonable chance of having that patent declared invalid and is thus consistent with the view of the managing director of the Alpharma group expressed in the email of 19 February 2002 and with the opinion set out by the IP director in his email of 26 January 2002, cited in recitals 1026, 1031 and 1032 of the contested decision.

123    Consequently, although some of the applicants’ arguments are well founded, they do not call into question the fact that, even in the light of the new factors mentioned in paragraphs 119 to 121 above and the advice mentioned in paragraph 122 above, the Alpharma group continued to consider that, despite the existence of certain risks, it had a reasonable chance of having the crystallisation patent declared invalid and that, in view in particular of the steps already taken and the investments already made, market entry thus remained a real concrete possibility, which was an alternative to concluding a sufficiently advantageous agreement with Lundbeck.

124    It must be made clear in that regard that the fact that conclusion of the agreement at issue may have represented for the parties thereto the most economically advantageous solution is irrelevant for the purpose of establishing whether the option of market entry was a real concrete possibility for the Alpharma group. Indeed, the fact that the adoption of anticompetitive conduct may prove to be the most cost-effective or least risky course of action for an undertaking in no way excludes the application of Article 101 TFEU (see, to that effect, judgments of 8 July 2004 in Corus UK v Commission, T‑48/00, ECR, EU:T:2004:219, paragraph 73, and Dalmine v Commission, T‑50/00, ECR, EU:T:2004:220, paragraph 211).

125    The present arguments must therefore be rejected.

126    In the third place, the applicants contend that the payments which the Alpharma group secured from Lundbeck do not permit the inference that those undertakings were potential competitors but are explained by the fact that the group’s ‘bluff’ succeeded and by the asymmetry of the risks, which placed Lundbeck at a disadvantage.

127    As a preliminary point in this regard, attention must be drawn to the fact that the payments in question were not the only factor on which the Commission relied in order to assess potential competition. In fact, it took that factor into account in the general context of (i) the steps which the Alpharma group had already taken and the investments that it had already made and (ii) the options which the group was considering, according to the documentary evidence available to the Commission.

128    Next, it must be observed, first, that the applicants have not produced any evidence which casts doubt on the fact that — as is apparent in particular from the emails mentioned in paragraph 108 above — a few days prior to the conclusion of the agreement at issue the Alpharma group was still considering market entry to be a real concrete possibility, which represented an alternative to concluding a sufficiently advantageous agreement with Lundbeck. Since the documents in question are internal to the Alpharma group, it cannot be maintained that they are intended to ‘bluff’ Lundbeck.

129    Secondly, Lundbeck — which was an experienced operator and which had over a long period been monitoring the steps taken by the generic undertakings with regard to citalopram, as demonstrated, in particular, by the warning letter of 11 January 2001, the letter mentioned in recital 496 of the contested decision and Lundbeck’s response to a request for information made by the Commission (which the applicants have produced in an annex to the application) — expected that the Alpharma group would enter the market, at the very least in the United Kingdom.

130    Furthermore, even after the agreement at issue had been signed, Lundbeck never complained that it had been the victim of a bluff; rather, as can be seen from recital 206 of the contested decision, it was delighted, in December 2002, that it had delayed the launch of generic citalopram, expected for the first quarter of 2002, which would have a positive effect on the sales development of its new medicinal product, Cipralex (see paragraph 11 above). In that regard, it follows from the evidence produced by the Commission, and in particular from the witness statement made by a Lundbeck staff member in the proceedings between Lundbeck and the generic undertaking Lagap Pharmaceuticals Ltd, that, in 2002, Lundbeck wished to prevent the price of Cipramil falling as a result of the arrival of generic citalopram on the market, since the level of that price would be decisive when it came to setting the price of Cipralex.

131    Therefore, in the absence of any evidence to support that assertion, it is not credible that the Alpharma group could have deceived Lundbeck over such a long period.

132    Furthermore, the fact, to which the applicants allude, that Lundbeck, in Article 1.3 of the agreement at issue, required the Alpharma group to produce its MA for the United Kingdom as a condition for Lundbeck’s making the second of the payments provided for, shows only that Lundbeck was not absolutely certain that the Alpharma group met all the conditions necessary for market entry but in no way contradicts the fact that, in Lundbeck’s view too, that group had a real concrete possibility of entering the market.

133    Thirdly, as regards the asymmetry of risks, it must be observed, first, that, by concluding the agreement at issue, both parties thereto were able to exchange uncertainties for certainties. The Alpharma group did not know whether its market entry would be successful and Lundbeck did not know whether it would be successful in litigation or what the presence of generics on the market would cause it to lose. By contrast, on the one hand, the payments provided for in that agreement constituted a definite benefit for the Alpharma group and, on the other hand, Lundbeck was assured that the group would comply with the obligations arising from that agreement. It follows that there were risks and benefits for both parties.

134    In so far as the applicants’ argument implies that the Alpharma group had little to lose as regards its market entry whilst the consequences of that entry for Lundbeck would have been disastrous, such an argument suggests rather that the group was a potential competitor, since it was ready to enter the market, at no great risk to itself, if it were not paid to refrain from doing so. In accordance with the case-law set out in paragraphs 63 to 65 above, the Alpharma group was thus exerting competitive pressure on Lundbeck.

135    Finally, it is true that asymmetry of risks can encourage a patent holder to make a transfer of value to generic undertakings capable of infringing the patent (a ‘reverse payment’) to avoid any risk, even slight, of those undertakings entering the market, especially where the patented product, like Cipramil in the present case, is the flagship product representing most of its turnover (see recitals 26 and 120 of the contested decision). However, the fact that conduct may be rational from an economic or commercial point of view does not exempt it from the application of the Treaty provisions on free competition, when it seeks to limit market access or even to exclude actual or potential competitors from that market and to share the benefits arising from that exclusion or limitation, to the detriment of consumers, that is to say, patients or health insurance schemes in the present case (see paragraph 124 above). In any event, it is apparent from the file that the risks were not as asymmetrical as the applicant claims. As has been noted in paragraph 89 above, Lundbeck acknowledged that there was a likelihood of between 50 and 60% that the crystallisation patent could be declared invalid. Furthermore, although Cipramil was Lundbeck’s flagship product, the Alpharma group had made, what was for it, significant investments to prepare for its market entry and sought a return on those investments.

136    In the light of all the foregoing, it may be concluded that the fact that it was probable that the Cipla process infringed the crystallisation patent did not represent for the Alpharma group a barrier to market entry of such magnitude that the group was not a potential competitor to Lundbeck (see, to that effect and by analogy, judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 59 above, EU:T:2012:332, paragraph 123).

–       The Alpharma group’s ability to enter the market with citalopram produced using the Matrix process

137    In recital 1035 of the contested decision, the Commission stated that, according to the email of 19 February 2002, instead of concluding the agreement at issue, the Alpharma group could have delayed its market entry until the spring or summer of that year and switched to citalopram produced using the Matrix process, which was not considered to be problematic as regards the crystallisation patent.

138    The applicants argue that the switch to citalopram produced using the Matrix process presented serious problems, including the need to carry out a further series of administrative steps.

139    Concerning that point, it must first be observed that the contract entered into between Tiefenbacher and the Alpharma group permitted the latter to obtain citalopram produced in accordance with the processes of both Cipla and Matrix (see paragraph 92 above). That is confirmed by an email from Tiefenbacher which the applicants have produced before the Court.

140    Secondly, it is true that the email of 19 February 2002 states that the switch to citalopram produced in accordance with the Matrix process would entail a delay in market entry, which would reduce expected profits. However, that drawback must be weighed against the advantage entailed by reducing the risk of infringing the crystallisation patent. In any event, that email in no way claims that, because of that delay and its consequences, the switch in question was not an economically viable option. It was simply a factor making it financially preferable to conclude an advantageous agreement with Lundbeck.

141    As has already been observed in paragraphs 124 and 135 above, that issue is irrelevant for the purpose of determining whether there was a real concrete possibility of the Alpharma group entering the market.

142    Thirdly, contrary to what the applicants maintain, the statement of 29 May 2002 does not undermine — on the ground that it allegedly demonstrates that the Alpharma group had some doubts about whether the Matrix process might infringe the crystallisation patent — the findings made above. In that regard, it is appropriate to refer to the reasoning set out in paragraphs 109 to 114 above. Moreover, assuming such ex post facto evidence to be relevant even though it sheds no light on the Alpharma group’s position prior to conclusion of the agreement at issue, it must be noted that the statement is inconsistent with the Alpharma group’s internal analysis from 2003 concerning the amounts of damages for patent infringement (see paragraph 95 above), which shows that, at that point, the option of launching citalopram produced in accordance with the Matrix process remained viable, at least in certain EEA countries.

143    Fourthly, the fact, alluded to by the applicants, that, subsequent to the conclusion of the agreement at issue, Matrix altered its process, as is stated in footnote No 155 of the contested decision, does not establish that the process that was previously available infringed the crystallisation patent, but merely shows the efforts subsequently made by Matrix to avoid all risk of infringement. Moreover, that alteration took place during the relevant period and the Alpharma group could therefore have used citalopram produced in accordance with the new Matrix procedure. In any event, on 19 February 2002, the Alpharma group took the view that the process that Matrix was using at the time could allow the group to enter the market without infringing the crystallisation patent.

144    Fifthly, as to the practical difficulties, mentioned by the applicants, which they claim would have been entailed by the switch to citalopram produced in accordance with the Matrix process and which concern amendment of the MAs, the supply chain for the tablets and approvals relating to the pricing of the product and to reimbursement by health insurance schemes, it must be noted that, as the Commission submits, the applicants have not demonstrated that it would have been impossible for the Alpharma group to react to those difficulties in such a way as to achieve market entry in the relevant period. Indeed, the email of 19 February 2002 referred only to a delay until the spring or summer of that year.

145    In any event, reference should be made to the analysis of potential competition set out in the contested decision and summarised in paragraphs 51 to 57 above, from which it is apparent that potential competition begins well before the point when a generic undertaking is ready to enter the market.

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

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

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

149    In those circumstances, all the steps which the applicants could have taken to prepare for the market launch of citalopram produced in accordance with the Matrix process amount to potential competition, as the Commission rightly observed in recital 1035 of the contested decision.

150    Sixthly, as to the fact, mentioned by the applicants, that the Alpharma group did not enter the market with Matrix citalopram as soon as the agreement at issue expired, the Court observes that such an argument confuses the concepts of potential competition and actual competition and is accordingly ineffective, by virtue of the grounds set out in paragraphs 145 to 149 above.

151    In any event, the agreement at issue significantly reduced the interest of the Alpharma group in moving swiftly to carry out the steps necessary to prepare market entry and make profits from sales, since it was in receipt of the substantial amounts that Lundbeck paid to it.

152    Furthermore, the applicants do not counter the Commission’s argument, set out in recital 548 and footnote No 999 of the contested decision and also put forward before the Court, that Tiefenbacher refused to work with the Alpharma group following the latter’s admission that citalopram produced using the Cipla process infringed Lundbeck’s new patents. Since, in order to obtain citalopram produced using Matrix’s new process, with which it finally entered the market, the Alpharma group needed to use Tiefenbacher, which was Matrix’s distributor, the Commission’s argument appears well founded.

153    Accordingly, the fact that the Alpharma group did not enter the market immediately after the relevant period does not affect the assessment of potential competition at the time when the agreement at issue was concluded.

154    In those circumstances, it must be concluded that, at the time of conclusion of the agreement at issue, even the switch to citalopram produced in accordance with the Matrix process, which was the second scenario considered in recital 1035 of the contested decision, represented for the Alpharma group a real concrete possibility of market entry.

155    Since the considerations set out in paragraphs 85 to 154 above permit the inference that the Alpharma group had at least two real concrete possibilities of entering the market and since those possibilities meant that it exerted competitive pressure on Lundbeck, it is not necessary to consider the question whether, in the contested decision, the Commission undertook a sufficient examination of whether the Alpharma group also had other possible routes to the market amongst the eight options outlined in recital 635 of the contested decision, which the applicants dispute.

156    In the light of the foregoing considerations, the present plea in law must be rejected.

 The first plea in law, alleging a manifest error of assessment as regards the Commission’s interpretation of the scope of the agreement at issue

157    The applicants claim that the Commission made a manifest error of assessment in considering that, by the agreement at issue, the Alpharma group had undertaken not to sell any generic citalopram during the relevant period. In their submission, the Commission did not have any evidence establishing that, instead of merely providing that the Alpharma group would refrain from selling generic citalopram that would infringe Lundbeck’s patents, including those set out in Appendix A, that agreement also prevented Alpharma from selling citalopram that would not infringe any patent owned by Lundbeck.

158    The applicants maintain that, although the wording of Article 1.1 (see the first indent of paragraph 16 above) is certainly not clear, as the Commission acknowledged during the administrative procedure, it may be concluded from the context and the available evidence that the word ‘Citalopram’ in that article must be interpreted as meaning that it refers only to citalopram that would infringe Lundbeck’s patents.

159    The Commission disputes the applicants’ arguments.

160    Before examining the applicants’ arguments in detail, the Court observes that the principles concerning the burden of proof have been set out in paragraphs 66 to 73 above.

161    It is in the light of those principles that the Court must determine whether the matters put forward by applicants are sufficient to call into question the Commission’s interpretation of the agreement at issue, on the basis of evidence relating to the wording of its provisions, to its preamble and to the context in which it came into being.

 Interpretation of the agreement at issue

162    The Commission, inter alia in recitals 1042, 1059 and 1061 of the contested decision, interpreted Article 1.1 as meaning that, by that article, the Alpharma group had agreed not to sell any citalopram during the relevant period, or, at least, had accepted restrictions on its ability to sell citalopram which greatly exceeded the restrictions that Lundbeck could have obtained by means of litigation on the basis of its new patents.

163    In order to support their contention that the restrictions on their conduct, which the Alpharma group had accepted under Article 1.1, did not exceed those inherent in the obligation to respect Lundbeck’s patents, including those listed in Appendix A, the applicants rely, in particular, on (i) the wording of Article 1.1, (ii) on certain recitals in the preamble, (iii) circumstances relating to the conclusion of the agreement at issue, (iv) the consent order of 2 May 2002, (v) certain documents of which the Commission allegedly failed to take due account and (vi) the date of the applicants’ market entry.

–       The wording of Article 1.1

164    It should be recalled that Article 1.1 stipulates that the Alpharma group, and its ‘affiliates’, ‘shall cancel, cease and desist from any importation, … production, … or sale of pharmaceutical products containing Citalopram in the Territory … during [the relevant period]’ and that Lundbeck is to withdraw the UK infringement action. It also states that that article does not apply to ‘any product containing escitalopram’.

165    According to the applicants, first, the fact that, in the agreement at issue, in particular in Article 1.1, the word ‘Citalopram’ was written with an upper case ‘C’ means that the parties to that agreement wished to employ a defined term, so as to refer only to citalopram that infringed Lundbeck’s patents. Next, they submit that the existence of a defined term is confirmed, a contrario, by the fact that, in Article 1.1, the word ‘escitalopram’ is not capitalised (see the second indent of paragraph 16 above). Finally, they submit that, in the body of Article 1.1, the word ‘any’ does not pertain to ‘Citalopram’ but rather to the importation, production or sale of ‘Citalopram’.

166    The Commission disputes the applicants’ arguments.

167    It must certainly be acknowledged that, as the applicants point out, throughout the agreement at issue, including in Article 1.1, the word ‘Citalopram’ is always written with an upper case ‘C’. Likewise, it is the case that that agreement uses words written with an initial upper case letter where it employs defined terms, as is the case with the words ‘Territories’ in the second recital in the preamble and ‘Subsidiaries’ in Article 1.1. However, those defined terms are set out explicitly, with a precise definition of their scope where they first appear. It is therefore clear that ‘Territories’ is a term used to refer to the group formed by the Member States, Norway and Switzerland, and the term ‘Affiliates’ refers to any company which, directly or indirectly, controls or is controlled or is under common control with Alpharma ApS.

168    By contrast, the agreement at issue contains no definition of the term ‘Citalopram’ which would enable a more restrictive meaning to be attributed to that term than that of its international non-proprietary name of citalopram, as an API recognised by the World Health Organisation (WHO), as the Commission notes.

169    Moreover, as the Commission stated correctly in recital 1050 of the contested decision and as it has submitted before the Court, the fact that Article 1.1 provides, right at the end, that it does not apply to escitalopram confirms that, where the parties to that agreement wished to restrict the scope of the obligations arising from that article, they did so explicitly.

170    In that regard, while the absence, highlighted by the applicants, of an upper case ‘e’ in the word ‘escitalopram’ reveals inconsistency in the spelling of words used in the agreement at issue to refer to APIs, it must be observed that that fact is not a sufficient ground for considering that the parties to that agreement wished to restrict the scope of the word ‘Citalopram’.

171    Likewise, whilst the applicants’ observation concerning the position of the word ‘any’ in Article 1.1 is correct, the fact remains that the expression ‘pharmaceutical products containing Citalopram’, although it does not contain the word ‘any’ in conjunction with ‘Citalopram’, nevertheless is of such general scope that it may be interpreted as meaning that it does not relate solely to citalopram produced using processes that were acknowledged to infringe Lundbeck’s new patents.

172    The applicants’ arguments relating to the wording of Article 1.1 must therefore be rejected.

–       The preamble

173    In order to assess the applicants’ arguments relating to the preamble, the content of the first, seventh and eighth recitals should be recalled.

174    According to the first recital in the preamble, ‘Lundbeck owns intellectual property rights including, in particular, patent rights relating to the manufacture and production of the [API] Citalopram, including the patents set out in Appendix A hereto’.

175    It follows from the seventh recital in the preamble that Lundbeck had filed the UK infringement action ‘seeking an injunction against sales [by the Alpharma group] of products containing Citalopram for infringing Lundbeck’s intellectual property rights’.

176    Finally, according to the eighth recital in the preamble, the Alpharma group acknowledged that the findings by Lundbeck in relation to the infringement of its patents were correct and undertook to refrain from marketing ‘such products’.

177    In the first place, the applicants maintain that, in the first recital of the preamble, the term ‘Citalopram’ is used to refer to citalopram produced using the processes covered by Lundbeck’s patents set out in the Appendix.

178    The Commission disputes the applicants’ arguments.

179    It must be observed, as the Commission noted in essence in recital 1047 of the contested decision, that the mere reference, in the first recital in the preamble, to the fact that Lundbeck owns patents relating to ‘Citalopram’, including those listed in Appendix A, does not allow the conclusion that the parties to the agreement at issue intended, even if only implicitly, to include a definition of the word ‘Citalopram’ which would not coincide with that normally attributable to citalopram without an upper case ‘c’, namely an API, irrespective of the process used to produce it.

180    In the second place, the applicants seek to rely on the seventh and eighth recitals in the preamble which, read together, in their submission permit the conclusion that the Alpharma group undertook not to sell citalopram produced in accordance with processes (i) which Lundbeck, in the context of the UK infringement action, had claimed infringed its new patents and (ii) in respect of which the Alpharma group had acknowledged that Lundbeck’s position was well founded.

181    The Commission disputes the applicants’ arguments.

182    In that respect, as the Commission in essence observed in recitals 1047 to 1049 of the contested decision and as it has submitted before the Court, the seventh and eighth recitals of the preamble do indeed recall the context in which the agreement at issue came about but are not decisive in terms of their ability to attribute restricted meaning to the word ‘Citalopram’. First, the seventh recital is not worded in terms defining that word, but refers to the application for an injunction prohibiting the sale of products containing ‘Citalopram’ on account of the infringement of patents belonging to Lundbeck. Secondly, even if, in the eighth recital, the expression ‘such products’ designates only products which contain citalopram synthesised using processes covered by that application for an injunction and which the Alpharma group acknowledged infringed Lundbeck’s patents, that fact does not permit the conclusion that, within the agreement at issue as a whole, including Article 1.1 thereof, the word ‘Citalopram’ included only those products.

183    In the absence of clear restrictions in the meaning of the word ‘Citalopram’ arising from the preamble, it may not be considered that, by mere references to the background to the conclusion of the agreement at issue, the parties to that agreement intended to restrict the scope of the obligations assumed by the Alpharma group solely to the citalopram acknowledged to have been produced in breach of Lundbeck’s new patents.

184    The applicants’ arguments in this regard must therefore be rejected.

–        Certain circumstances relating to the conclusion of the agreement at issue

185    The applicants maintain that the agreement at issue was essentially drafted by Lundbeck and that under Danish law, which governs the agreement, ambiguous terms must be interpreted against the drafter. It is obvious that only Lundbeck had an interest in the Alpharma group entering into a contractual obligation not to sell any citalopram during the relevant period. Moreover, according to the applicants, even Lundbeck’s interest in that regard must be qualified since it would have made little sense for Lundbeck to pay the Alpharma group to refrain from selling citalopram that did not infringe its patents when such citalopram, assuming that it existed, could in any event have been placed on the market by other generic undertakings.

186    The Commission disputes the applicants’ arguments.

187    In this connection, the Court finds that it can be seen from the documents before it, in particular from a number of Alpharma group internal emails of 20 February 2002, included in the administrative case file and produced before the Court, that the Alpharma group played an active role in the drafting of the agreement at issue. Those emails refer to a revised version of the agreement at issue which was produced following comments from employees of the Alpharma group and outside counsel. It is also stated therein that when the revised text came to be sent to Lundbeck, the latter should be informed that the changes had been made since the text might differ from what it was expecting.

188    It follows that the applicants’ present argument has no basis in fact, irrespective of what the applicable law may be and the possible consequences thereof.

189    In any event, the Court observes that both Lundbeck and the Alpharma group were well-informed and seasoned operators in the pharmaceutical sector and had made qualified staff and advisers responsible for negotiating the agreement at issue. Therefore, it cannot be presumed that the drafting of the provisions of that agreement was vague, much less that possible ambiguities in those provisions pursued the interests of a single party. The fact, also advanced by the applicants, that the Commission, during the administrative procedure, asked those undertakings for their observations on the scope of the agreement at issue shows that the Commission observed the adversarial principle but does not affect the validity of the interpretation of Article 1.1 which it adopted in the contested decision.

190    Finally, as to the fact, relied on by the applicants, that other generic undertakings could have brought to the market forms of generic citalopram which, in the applicants’ submission, were not covered by Article 1.1, it should be noted that, while knowing that it could not prevent generic citalopram from ever entering the market, Lundbeck was seeking to delay that entry. The exclusion of the Alpharma group, which had taken numerous steps with the aim of entering the market, formed part of that strategy.

191    It follows that the scope of the agreement at issue was defined by both parties thereto, who shared the aim of reaching a mutually advantageous agreement, as the Commission in essence stated in recitals 1076 to 1079 of the contested decision.

192    Consequently, the applicants’ arguments must be rejected.

–       The consent order of 2 May 2002

193    The applicants refer to the consent order of 2 May 2002 (see paragraph 18 above), the terms of which are relevant for the purpose of interpreting Article 1.1, inasmuch as that order was made in order to put an end to the UK infringement action following the conclusion of the agreement at issue. In that regard, the applicants emphasise that the order, whilst imposing on the Alpharma group restrictions coinciding, including from a territorial point of view, with the restriction arising under Article 1.1, specifies that the scope of those restrictions is limited to ‘pharmaceutical products containing citalopram made utilising any of the processes claimed under [Lundbeck’s new patents]’. The applicants also take issue with the argument set out in the contested decision that the consent order of 2 May 2002 was drafted more narrowly than Article 1.1 because it would otherwise have been difficult for a court to agree to it.

194    The Commission disputes the applicants’ arguments.

195    In that regard, it is indeed true that the consent order of 2 May 2002 is worded in the terms referred to by the applicants, which clearly include restrictions on the Alpharma group’s conduct which are less broad than those arising from Article 1.1, as interpreted by the Commission in the contested decision.

196    It is also true that there is a connection between that order and the agreement at issue. That order was adopted in order to stay the UK infringement action, precisely because the agreement at issue had been concluded.

197    Nevertheless, those factors are not sufficient to interpret Article 1.1 as coinciding with the scope of the consent order of 2 May 2002.

198    As the Commission noted in recital 1054 of the contested decision, the two are separate legal instruments. What matters in order for it to be possible for the agreement at issue to have constituted the reason for the consent order of 2 May 2002 is that the obligations accepted by the Alpharma group under the agreement at issue should be sufficient that, throughout the term of that agreement, Lundbeck had no further interest in pursuing the UK infringement action, which was limited to the question whether the Alpharma group was already infringing Lundbeck’s new patents. That condition is fulfilled, even if the scope of the Alpharma agreement exceeds that of that order.

199    Moreover, since it was not necessary to disclose before the national court which adopted the consent order of 2 May 2002 the precise scope of the agreement at issue, it is entirely reasonable that Lundbeck and the Alpharma group merely restated, in the text of the order that they submitted to that court, only the obligations arising from that agreement that were relevant for the purposes of the UK infringement action. Furthermore, the lack of a direct correspondence between the agreement at issue and the order of 2 May 2002 is confirmed by the fact that the order makes no reference to the fact that that agreement provided for a payment to the Alpharma group, even though that was a fundamental element with regard to its conclusion.

200    It follows that the consent order of 2 May 2002 does not allow Article 1.1 to be interpreted in the sense suggested by the applicants.

201    The applicants’ present arguments thus cannot succeed.

–       Certain documents of which the Commission did not take due account

202    The applicants complain that the Commission failed to take due account of a number of documents, prepared immediately before and after the agreement at issue was concluded, which they maintain support their interpretation of Article 1.1.

203    In the first place, the applicants refer to the email of 19 February 2002 (see paragraph 85 above). They argue that the managing director of the Alpharma group who was responsible for the relevant dossier mentioned in that email not only the possibility of concluding an agreement with Lundbeck but also that of entering the market, within three to four months, with citalopram tablets which Tiefenbacher could supply to the Alpharma group using the Matrix API. According to the applicants, it was not necessarily a question of mutually exclusive options, as the Commission held in the contested decision, but of cumulative options, provided that the Alpharma group could actually obtain that API.

204    The Commission disputes the applicants’ arguments.

205    In that regard, it follows from the very wording of the email of 19 February 2002 that its author presented the settlement with Lundbeck and market entry, including with the Matrix API, as alternative options and not as cumulative options.

206    That conclusion is borne out by the fact that, as the Commission points out, the author of the email of 19 February 2002, in the email of 14 February 2002 (see paragraph 105 above) explained to one of his colleagues that, at that time, the Alpharma group was employing a dual strategy, as shown by the expression ‘we are riding two horses’, consisting, on the one hand, of planning the launch of citalopram in several EEA countries and, on the other hand, of negotiating with Lundbeck, and that, the following week, it would probably be necessary to make a decision. In that respect, he stated that, in order to take the best possible decision, he needed a description of the legal situation in each of those countries and of the risks to which the Alpharma group was exposed.

207    Consequently, the applicants have no grounds for maintaining that the email of 19 February 2002 demonstrates that the agreement at issue was drafted in terms which kept open the option of entering the market with citalopram considered not to infringe Lundbeck’s new patents.

208    In the second place, the applicants rely on a statement which the managing director of the Alpharma group who wrote the email of 19 February 2002 made to the press on 28 February 2002 (‘the statement of 28 February 2002’). That statement mentioned the fact that the launch of generic citalopram had been postponed but that the possibility of its taking place after the summer holiday period was not ruled out, if the difficulties arising from Lundbeck’s new patents were resolved in the meantime. They argue that, since the relevant period extended well beyond those holidays, that statement confirms that Article 1.1 did not prevent the Alpharma group from selling all citalopram during that period.

209    The Commission disputes the applicants’ arguments.

210    It must be observed that, by the statement of 28 February 2002, the Alpharma group announced, in essence, that it was postponing sales of citalopram until at least the end of the summer holiday period and that it might, if necessary, abandon that sales project, on the ground that there was a problem with its stock in view of Lundbeck’s patents. It added that it had to seek a new API producer and obtain the necessary authorisations.

211    It must be noted that, as the Commission stated in recital 1055 of the contested decision, that statement, which post-dates the conclusion of the agreement at issue, presents the Alpharma group’s change of plans as the result of a unilateral decision on its part, separate from the payments provided for in the agreement at issue. The considerations set out in paragraphs 110 to 114 above concerning the statement of 29 May 2002 are therefore applicable by analogy. It follows that the statement of 28 February 2002 is not a significant contextual element in interpreting the scope of the agreement at issue.

212    In any event, it must be observed that, although the Alpharma group mentioned the possibility of entering the market after the summer, it also referred to the possibility of abandoning the project, a possibility which is consistent with the Commission’s interpretation of the agreement at issue.

213    Under those circumstances, that press statement does not allow the conclusion that Article 1.1 concerned only citalopram produced in accordance with processes acknowledged to be infringing.

214    In the third place, the applicants refer to an email of 12 March 2002 from a manager at Lundbeck involved in the relevant dossier (‘the email of 12 March 2002’), referred to in recital 1056 of the contested decision. That manager asserted in the email that, although there was considerable uncertainty, he did not believe that the Alpharma group would enter the United Kingdom market with generic citalopram in the foreseeable future. According to the applicants, since it was not conceivable that the Alpharma group would breach the agreement at issue, there would have been no uncertainty if Article 1.1 had the scope which the Commission attributes to it. In their view, that uncertainty concerned whether the Alpharma group might obtain citalopram that did not infringe Lundbeck’s new patents.

215    The Commission disputes the applicants’ arguments.

216    As the Commission observes, the email of 12 March 2002 is a response to another email which mentioned a price list from the Alpharma group relating to citalopram and asked the addressee to check the situation with that group. According to the Commission, since, in his reply to that request, the author of the email of 12 March 2002 indicates that it is probably an old price list and specifies that he has not contacted the Alpharma group on that matter, there is nothing in that email which calls into question the contested decision’s interpretation of the scope of the agreement at issue.

217    If the scope of the agreement at issue was limited to citalopram produced in accordance with the Cipla process, which the Alpharma group had already received or ordered, Lundbeck ought to have been concerned about that price list, with the result that the author of the email of 12 March 2002 would have probably taken steps to determine whether the group had already been able to obtain citalopram produced in accordance with other processes which were not covered by the obligations arising from the agreement at issue interpreted in that manner. Therefore, the fact that the author of that email did not follow up on the request he had received from his colleague while stating that he did not think that the Alpharma group would enter the market in the foreseeable future suggests that he considered that the agreement at issue did not concern only citalopram produced in accordance with the Cipla process.

218    However, since these are mere hypotheses, it must be noted that the email of 12 March 2002 does not allow firm conclusions to be drawn as to the scope of the agreement at issue. In that regard, it must be noted that the Commission did not rely on that email to substantiate its interpretation, but mentioned it in the contested decision solely for the purpose of rejecting an argument which the applicants sought to derive from the email in support of their interpretation of the agreement at issue.

219    In the fourth place, the applicants deny that the Commission’s interpretation of Article 1.1 is confirmed by the email of 20 February 2002 from an Alpharma group executive (‘the email of 20 February 2002’), according to whom the agreement at issue lacked a clause specifying that Lundbeck would not oppose Alpharma’s entry to the market after the expiry of that agreement. They submit that that statement does not mean that the Alpharma group had to remain outside the market until that expiry. They also state that the executive concerned was on holiday when the agreement at issue was concluded and that he commented on an unknown draft of that agreement.

220    The Commission disputes the applicants’ arguments.

221    It must be recalled that, according to the extract from the email of 20 February 2002 reproduced in recital 1051 of the contested decision, the IP director (see paragraph 119 above) commented as follows on the draft of the agreement at issue which had been sent to him:

‘I miss something stating that Lundbeck don’t carry on with the same old argument after June 2003. If we for instance change to Matrix API and we are free of the Lundbeck patent, then I don’t want to be dragged round the circus once more.’

222    The full version of that email, which is included in the Commission’s case file and has been produced before the Court, shows that the IP director in question proposed adding the following recital to the preamble:

‘Whereas, Lundbeck has agreed not to injunc[t] or otherwise prosecute [the Alpharma group] for manufacturing, importing, selling, etc. Citalopram containing product[s] after the termination of this contract.’

223    Whilst it is true that a recital such as that mentioned in paragraph 222 above is not included in the agreement at issue, the fact remains that the IP director took the view that the version of the agreement at issue on which he was commenting included an obligation on the Alpharma group to remain outside the market during the relevant period, not only as regards citalopram produced in accordance with the Cipla process which it had already received or ordered but also as regards citalopram produced in accordance with other processes, including Matrix’s, which was considered not to be problematic so far as Lundbeck’s new patents were concerned (see the fifth indent of paragraph 85 above).

224    It is true that the applicants are correct when they observe that neither the Commission nor the Court has the draft of the agreement at issue on which the IP director commented.

225    Thus, it is not possible to determine whether Article 1.1 as it appeared in that draft corresponded to the article as it appears in the definitive version of the agreement at issue.

226    However, it must be noted that, given the concern expressed in the email of 20 February 2002, it is clear that the word ‘Citalopram’ was used by the IP director to refer also to citalopram produced in accordance with the Matrix process. Moreover, the Alpharma group employee to whom that email was sent replied that the agreement at issue was being revised and that she was waiting for a new draft.

227    In those circumstances, it must be concluded that, if the parties to that agreement had wanted, when the final revisions were being made, to give a narrower meaning to the word ‘Citalopram’, they would have done so explicitly; that was not the case, however.

228    As to the applicants’ argument that the IP director who wrote the email of 20 February 2002 was on holiday when the agreement at issue was being negotiated, the Court observes that it is apparent from the documents before it that he was not on holiday on 18 February 2002, when he replied to an email which had been sent to him on 13 February 2002. He therefore had full knowledge of the facts when he wrote the email of 20 February 2002. Furthermore, account must be taken of the fact that, as the Commission submits, relying on two emails from the Alpharma group of 23 and 24 January 2002 which are included in the Commission’s case file and have been produced before the Court, the IP director was Alpharma’s patent expert. It is therefore inconceivable that he should have been kept out of the negotiations concerned.

229    Consequently, the Court upholds the conclusion which follows from recital 1051 of the contested decision that the email of 20 February 2002 is an important item of evidence permitting the inference that the agreement at issue must be interpreted to the effect that the obligations undertaken by the Alpharma group in Article 1.1 were not limited to citalopram produced in accordance with the processes which were acknowledged to infringe Lundbeck’s new patents.

230    The applicants’ present arguments must therefore be rejected.

231    In the fifth place, the applicants submit that the interpretation of Article 1.1 is not affected by the fact that, in an email of 6 November 2002 to an Alpharma-group employee (‘the email of 6 November 2002’), a Lundbeck employee stated that he was proceeding on the principle that the tablets which, under Article 2.2 of the agreement at issue (see the last indent of paragraph 16 above), were to be delivered to Lundbeck had been produced by Tiefenbacher with Matrix’s API rather than Cipla’s. They submit that, given the considerable delay in the Alpharma group’s delivering to Lundbeck the last part of the stock which it had ordered from Tiefenbacher, it was natural that Lundbeck should ask whether Tiefenbacher had changed API producer.

232    The Commission disputes the applicants’ arguments.

233    As a preliminary point, the Court notes that, as the Commission acknowledged at the hearing, the email of 6 November 2002 is the same document as the one mentioned, with the incorrect date of 7 November 2002, in recitals 543 and 1051 of the contested decision.

234    In addition, it must be recalled that, under Article 2.2 of the agreement at issue, the Alpharma group was — no later than 31 March 2002 — to deliver to Lundbeck its entire current stock of products containing ‘Citalopram’.

235    It follows from the documents before the Court that that delivery was delayed with the result that, in November 2002, that obligation had not yet been fully performed.

236    It was against that background that, in response to an email from the Alpharma group stating that there would be a delivery at the end of the month, Lundbeck, in the email of 6 November 2002, stated that it was proceeding on the basis that the shipment concerned tablets containing citalopram produced in accordance with the new Matrix process.

237    Since that delivery entailed performing, belatedly, the obligation laid down in Article 2.2 of the agreement at issue, which contains the same term ‘Citalopram’ as that used in Article 1.1, the Commission could logically conclude that the email of 6 November 2002 supported its interpretation of the scope of the latter term, which was thus not limited to citalopram produced in accordance with the Cipla process, whose infringing nature was acknowledged by the parties to that agreement.

238    In that regard, it should be acknowledged that, from a quantitative point of view, the tablets in question had already been ordered by the Alpharma group from Tiefenbacher before the conclusion of the agreement at issue. However, from a qualitative point of view, it is clear that, if that agreement had had the scope which the applicants claim it did, it could not have formed the basis for that delivery. If the aim of the agreement at issue had been limited to the Alpharma group delivering to Lundbeck tablets containing citalopram which the parties accepted infringed Lundbeck’s new patents, that agreement could not have been a basis for the delivery of tablets containing citalopram produced in accordance with a process — Matrix’s — which the parties did not consider to infringe those patents.

239    It follows that the email of 6 November 2002 precludes the interpretation of Article 1.1 which the applicants advocate, as the Commission in essence found in recital 1051 of the contested decision.

240    In view of all the foregoing observations concerning the documents relied on by the applicants, it must be concluded that none of those documents supports the restrictive interpretation of the obligations laid down in Article 1.1 which the applicants put forward.

–       The date of the Alpharma group’s market entry

241    The applicants point out that the Alpharma group did not enter the market immediately upon expiry of the agreement at issue (30 June 2003) but did so only from August 2003, which means, so they argue, that it was not the obligations entered into in Article 1.1 which had prevented the group from entering the market at an earlier date. According to the applicants, even at the end of the relevant period there was uncertainty about whether it was possible to sell generic citalopram without infringing Lundbeck’s new patents. In particular, it was not certain whether the Matrix process was non-infringing with regard to those patents.

242    The Commission disputes the applicants’ arguments.

243    In that regard, the Court notes that the considerations set out in paragraphs 151 to 153 above support the conclusion that the fact that the Alpharma group did not enter the market immediately after the relevant period does not affect the interpretation to be given to Article 1.1. Reasons other than the uncertainties to which the applicants refer explain that market entry was subsequently delayed. Moreover the fact that there may have been uncertainties regarding the infringing nature of the Matrix process does not call in question the fact that the agreement at issue gave Lundbeck the certainty that the applicants would not enter the market, during the relevant period, with citalopram produced in accordance with the Matrix process.

 Conclusions on the scope of the obligations entered into by the Alpharma group

244    In the light of all the foregoing considerations, it must be held that the Commission has proved to a sufficient legal standard that a literal, contextual and teleological interpretation of the agreement at issue allowed the conclusion that the obligations assumed by the Alpharma group under Article 1.1 were not limited to citalopram produced in accordance with processes which that group and Lundbeck had acknowledged infringed Lundbeck’s new patents. Those obligations concerned not only the citalopram that the Alpharma group already had in stock, produced in accordance with the Cipla process, but also citalopram that it had ordered or would have ordered from Tiefenbacher, irrespective of the process used by the API producer which supplied Tiefenbacher.

245    That interpretation of Article 1.1 is sufficient for the view to be taken that the obligations undertaken therein by the Alpharma group exceeded those that Lundbeck could have obtained through enforcement of its new patents.

246    In those circumstances it is not necessary to consider whether, as the Commission maintained in recitals 1062 to 1064 of the contested decision and as it argues before the Court, the fact that Article 1.2 of the agreement at issue (see the third indent of paragraph 16 above) stipulates that the Alpharma group agrees voluntarily to submit to an interim injunction not only ‘in the event of any breach of the obligation set forth in Article 1.1’ but also ‘at the request of Lundbeck’ shows that Lundbeck had a right of veto over any sale of generic citalopram by the Alpharma group during the relevant period.

247    Since the applicants have not succeeded in rebutting the evidence by which the Commission proved that the agreement at issue included restrictions for the Alpharma group which went beyond those that Lundbeck could have obtained by relying on its new patents and winning its case in the event of litigation in that regard, the present plea must be rejected.

 The third plea in law, alleging a manifest error of assessment in the characterisation of the agreement at issue as a restriction of competition by object

248    The applicants maintain that the agreement at issue does not correspond to the concept of a restriction by object within the meaning of Article 101(1) TFEU, a concept which is to be interpreted strictly, as is clear from the judgment in CB v Commission, cited in paragraph 41 above (EU:C:2014:2204).

249    The Commission disputes the applicants’ arguments.

250    Before examining the applicants’ arguments in further detail, it is necessary to make some preliminary observations on, inter alia, the judgment in CB v Commission, cited in paragraph 41 above (EU:C:2014:2204), and briefly to recall the analysis relating to the existence of a restriction of competition by object made in the contested decision.

 Preliminary observations

251    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.’

252    In that regard, it is clear from the case-law that certain types of coordination between undertakings reveal a sufficient degree of harm to competition for the examination of their effects to be considered unnecessary (judgment in CB v Commission, cited in paragraph 41 above, EU:C:2014:2204, paragraph 49; see also, to that effect, judgments of 30 June 1966 in LTM, 56/65, ECR, EU:C:1966:38, pp. 249 and 250, and 14 March 2013 in Allianz Hungária Biztosító and Others, C‑32/11, ECR, EU:C:2013:160, paragraph 34).

253    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 41 above, EU:C:2014:2204, paragraph 50; see also, to that effect, judgment in Allianz Hungária Biztosító and Others, cited in paragraph 252 above, EU:C:2013:160, paragraph 35 and the case-law cited).

254    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 41 above, EU:C:2014:2204, paragraph 51; see also, to that effect, judgment of 20 November 2008 in Beef Industry Development Society and Barry Brothers, C‑209/07, ECR, ‘the BIDS judgment’, EU:C:2008:643, paragraphs 33 and 34).

255    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 252 above, EU:C:2013:160, paragraph 34, and CB v Commission, cited in paragraph 41 above, EU:C:2014:2204, paragraph 52).

256    In order to establish the anticompetitive nature of an agreement and assess whether it reveals a sufficient degree of harm to competition that it may be considered a restriction of competition by object for the purpose of Article 101(1) TFEU, regard must be had to the content of its provisions, its objectives and the economic and legal context of which it forms a part. When determining that context, it is also necessary to take into consideration the nature of the goods or services affected, as well as the real conditions of the functioning and structure of the market or markets in question (judgments in Allianz Hungária Biztosító and Others, cited in paragraph 252 above, EU:C:2013:160, paragraph 36, and CB v Commission, cited in paragraph 41 above, EU:C:2014:2204, paragraph 53).

257    In addition, although the parties’ intention is not a necessary factor in determining whether an agreement between undertakings is restrictive, there is nothing prohibiting the competition authorities, the national courts or the Courts of the European Union from taking that factor into account (judgments in Allianz Hungária Biztosító and Others, cited in paragraph 252 above, EU:C:2013:160, paragraph 37, and CB v Commission, cited in paragraph 41 above, EU:C:2014:2204, paragraph 54).

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

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

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

260    It therefore considered 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 reverse payment (recitals 639 and 640 of the contested decision).

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

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

263    It must be noted, in that respect, that the Commission did not assert, in the contested decision, that all patent settlement agreements containing reverse payments were contrary to Article 101(1) TFEU; 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 object of the agreements in question was to restrict competition, within the meaning of Article 101(1) TFEU, in the present case (see recitals 661 and 662 of the contested decision).

264    As regards more specifically the classification of the agreement at issue, the main factors relied upon by the Commission are those referred to in paragraph 32 above.

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

 The existence of a restriction by object in the present case

266    It should be observed that the examination of the first and second pleas has shown that (i) by the agreement at issue, the Alpharma group undertook not to enter the market during the relevant period, on the terms set out in paragraph 244 above, in return for the amounts paid to it by Lundbeck and (ii) the Alpharma group was a potential competitor of Lundbeck.

267    As the Commission appositely pointed out in recitals 1300, 1331, 1332, 1338, 1361 and 1362 of the contested decision, that is, in essence, a market exclusion agreement. Such an agreement broadly equates to two examples of particularly restrictive agreements covered by the non-exhaustive list contained in Article 101(1) TFEU, namely those listed under points (b) and (c) (see paragraph 251 above), since market exclusion is an extreme form of the desire to share a market and limit production.

268    Furthermore, even assuming that, as the applicants maintain, the scope of the agreement at issue coincided with that of Lundbeck’s new patents, that would not affect the possibility, referred to in recital 1035 of the contested decision, of the Alpharma group entering the market with tablets which it had already received or ordered (see paragraph 83 above); therefore the Commission would in any event have been justified in considering the agreement at issue to be a restriction of competition by object. Even if that assumption were accepted, it would have to be concluded that the Alpharma group had forgone, in return for a reverse payment, the possibility of entering the market with citalopram produced in accordance with the Cipla process, which was alleged to infringe a patent in respect of which there was a reasonable chance of it being declared invalid. That possibility was real and concrete for the Alpharma group, as is apparent from the examination of the second plea, with the result that the payment was a determining factor in its decision to forgo it.

269    Accordingly, the Commission, which bears the burden of proof, in accordance with the case-law referred to in paragraphs 66 to 73 above, had sufficient evidence to classify the agreement at issue as a restriction by object, unless other factors relating to its objectives, viewed in their economic and legal context, gave it grounds for finding that the agreement was not sufficiently harmful to competition.

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

271    Nevertheless, the Commission also relied on earlier case-law, which the judgment in CB v Commission, cited in paragraph 41 above (EU:C:2014:2204), did not call into question.

272    It is true that, in the judgment in CB v Commission, cited in paragraph 41 above (EU:C:2014:2204), the Court of Justice rejected the General Court’s analysis in the judgment in CB v Commission, cited in paragraph 270 above (EU:T:2012:633), according to which the concept of restriction of competition by object should not be interpreted restrictively. The Court of Justice noted that the concept of restriction of competition by object could be applied only to certain types of coordination between undertakings which revealed a sufficient degree of harm to competition that it could be found that there was no need to examine their effects, otherwise the Commission would be exempted from the obligation to prove the actual effects on the market of agreements which were in no way established to be, by their very nature, harmful to the proper functioning of normal competition (see, to that effect, judgment in CB v Commission, cited in paragraph 41 above, EU:C:2014:2204, paragraph 58).

273    However, it does not follow that the Commission was required to examine the effects of the agreement at issue if it was able to establish, to the requisite legal standard, that the agreement could be considered — in view of its content, the scope of its provisions and its objectives, taken in their economic and legal context — to be sufficiently harmful to competition (paragraphs 254 to 256 above).

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

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

275    The applicants maintain that the objective aim of the agreement at issue was to settle a genuine dispute, which concerned the UK infringement action and related in particular to what to do with the citalopram tablets which the Alpharma group had received or ordered.

276    The Commission disputes the applicants’ arguments.

277    It should be observed at the outset that an agreement may be regarded as having a restrictive object even if it does not have the restriction of competition as its sole aim but also pursues other legitimate objectives (see the BIDS judgment, cited in paragraph 254 above, EU:C:2008:643, paragraph 21 and the case-law cited). Similarly, it must be recalled that, according to the case-law, an agreement is not exempt from competition law merely because it concerns a patent or is intended to settle a patent dispute (see, to that effect, judgment of 27 September 1988 in Bayer and Maschinenfabrik Hennecke, 65/86, ECR, EU:C:1988:448, paragraph 15).

278    Next, it must be recalled that the examination of the first plea permitted the Court to establish that the agreement at issue had a broader scope than that of the UK infringement action, which related specifically to the tablets which the Alpharma group had already received or ordered.

279    In any event, that action was simply suspended for the relevant period, with no guarantee that it would be withdrawn at the end of that period. The agreement at issue does not provide that Lundbeck should subsequently refrain from pursuing the Alpharma group for infringement of its new patents. Moreover, it is clear from Lundbeck’s statement cited in recital 80 of the contested decision that it did not consider that the agreements in question, including the agreement at issue, resolved any dispute.

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

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

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

283    The applicants’ present arguments must therefore be rejected.

–       Lack of certainty as regards the outcome of a potential patent dispute

284    The applicants claim that the Commission did not establish with certainty that the Alpharma group would be likely to prevail in a potential patent dispute with Lundbeck.

285    The Commission disputes the applicants’ arguments.

286    In that regard, it suffices to observe that an agreement can have a restrictive object even if it restricts only potential competition.

287    It was held in the context of the examination of the second plea in law that the Alpharma group had real concrete possibilities of entering the market instead of concluding the agreement at issue and was therefore a potential competitor to Lundbeck. Accordingly, the Commission was not required to establish with certainty that the Alpharma group would have been successful if it had opted for litigation.

288    In fact, that argument seeks to call into question the distinction between actual and potential competition, inasmuch as, in the applicants’ view, no potential competition can exist as long as it has not been shown with absolute certainty that, in the absence of the agreement at issue, the Alpharma group would have actually entered the market with its generic citalopram, if need be after succeeding in any litigation that could have arisen between it and Lundbeck. Such an argument has already been rejected in the examination of the second plea in law.

289    Accordingly, the applicants’ present argument is unfounded.

–       The amounts of the payments made by Lundbeck

290    In the applicants’ submission, the amount that the Alpharma group received from Lundbeck pursuant to the agreement at issue was much lower than the profits that it was expecting to make from the sale of the citalopram tablets which it had already received or ordered. The Commission failed to take account of the sale prices published by the Alpharma group, the application of which would have brought the group USD 17.1 million. In any event, even if the profits that the Alpharma group might have obtained by entering the market could be estimated at USD 10 million, as the Commission claims on the basis of the email of 19 February 2002, the applicants submit that the agreement at issue produced a lower profit, since it was necessary to deduct from the amount paid by Lundbeck the costs already incurred by the Alpharma group, which, moreover, are difficult to estimate owing to the length of the Commission’s investigation, but which reduce the profits from the agreement to USD 7.7 million at most.

291    The applicants submit that the fact that the profits made pursuant to the agreement at issue were lower than the profits expected as a result of the Alpharma group’s market entry shows that the group was seriously concerned about the risk of infringing Lundbeck’s new patents; the reasons for concluding the agreement at issue thus lay largely in the strength of Lundbeck’s patents and not in the payment received by the group.

292    The Commission disputes the applicants’ arguments.

293    In the first place, it must be stated that, as the Commission rightly observes, the applicants have no grounds for stating that they expected profits amounting to USD 17.1 million. First, it must be noted that the amount referred to by the applicants corresponds to turnover rather than profit. Next, the applicants’ new calculation is based on retail prices pertaining solely to the United Kingdom and concerning only one month: that is not a reliable basis. Finally and most importantly, the argument now put forward by the applicants conflicts with the email of 19 February 2002, which states that the net profit expected from market entry was USD 10 million. As the Commission rightly pointed out in footnote No 1865 of the contested decision, the assessment which the Alpharma group managing director who wrote that email made three days before the agreement at issue was concluded is clearly the most reliable indication in this regard, drawn up in tempore non suspecto.

294    In the second place, it should be observed that the total of the payments made by Lundbeck to the Alpharma group under Article 1.3 of the agreement at issue — namely USD 12 million of which USD 11 million represented ‘compensation’ for the group’s agreeing to deliver to Lundbeck the citalopram tablets which it had received or ordered — corresponds essentially to the estimated profit in the email of 19 February 2002.

295    In that regard, it must be recalled that, as is apparent from the internal Alpharma group email referred to in recital 1077 of the contested decision, on 21 January 2002 the Alpharma group was considering concluding an agreement with Lundbeck in the event inter alia of Lundbeck agreeing to pay an amount of between USD 18 and 20 million. The fact that, one month later, the Alpharma group signed an agreement entailing a lower payment shows that — probably because of information obtained in the meantime as to the risks of infringement and the chances of obtaining a declaration of invalidity in respect of the crystallisation patent — it had revised its terms downwards, whilst retaining a significant profit.

296    In the third place, as is apparent from the explanation which Lundbeck provided to the Commission, as set out in recital 526 of the contested decision, the sum of USD 12 million provided for in the agreement at issue was paid ‘in lieu of any damages that might be available to [the Alpharma group] in the event that its citalopram products were not infringing’. In recital 1071 of the contested decision, the Commission correctly observed that that reference to damages implied that Lundbeck’s payment was linked to the profits expected by the Alpharma group. Indeed, the amount of those damages necessarily depended on the size of the profits which the group could have made from its sales of generic citalopram.

297    In the fourth place, as regards the applicants’ argument that it is necessary to deduct from the amount paid by Lundbeck the costs which the Alpharma group had incurred, in particular USD 3.9 million, corresponding to EUR 3.7 million, in buying or ordering citalopram, it must first of all be noted that those costs were not incurred for the purposes of the conclusion of the agreement at issue; consequently they are not to be deducted from the profit which the agreement generated for the group.

298    Next, on the assumption that it was necessary to deduct those costs from that profit, the Alpharma group would admittedly have received a lower net sum than the profit mentioned in the email of 19 February 2002. However, that sum represented a definite profit for the Alpharma group, whereas the profits that might arise from market entry were subject to uncertainties.

299    Finally, in so far as the applicants rely on the asymmetry of risks, a similar argument was rejected in the context of the assessment of the second part of the second plea in law (see paragraphs 133 to 135 above).

300    The applicants’ present arguments must therefore be rejected.

–       Analogies with the case giving rise to the BIDS judgment

301    The applicants deny that the circumstances of the present case can be treated — as the Commission treated them in the contested decision — as being analogous to the circumstances of the case that gave rise to the BIDS judgment, cited in paragraph 254 above (EU:C:2008:643) (‘the BIDS case’). They submit that the existence in the present case of patents is a critical difference between the agreement in question in the BIDS case and the agreement at issue.

302    The Commission disputes the applicants’ arguments.

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

304    That finding of the Commission must be upheld.

305    As can be seen from, inter alia, paragraph 8 of the BIDS judgment, cited in paragraph 254 above (EU:C:2008:643), the undertakings active on the beef processing market in Ireland had created a mechanism by which some undertakings agreed to stay out of that market for two years in exchange for payments from the undertakings that stayed in the market. A similar dynamic arose in the present case through the conclusion of the agreement at issue, pursuant to which the principal, or even the only, undertaking present on the market with citalopram in the countries concerned by that agreement, paid the applicants, which were potential competitors, so that they would stay out of the market for a given period.

306    It follows that both the BIDS case and the present case concern agreements that limited the ability of competing economic operators to determine independently the policy that they intended to adopt on the market, by preventing the normal operation of the competitive process (see, to that effect, the BIDS judgment, cited in paragraph 254 above, EU:C:2008:643, paragraphs 33 to 35).

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

308    Furthermore, it must be recalled that, in paragraphs 84 and 85 of the judgment in CB v Commission, cited in paragraph 41 above (EU:C:2014:2204), the Court of Justice essentially highlighted the fact that the agreements referred to in the BIDS case changed the structure of the market and revealed such a degree of harm that they could be classified as a restriction by object, whereas that was not the case of the conduct at issue in the case that gave rise to the judgment in CB v Commission, which consisted in the obligation imposed on banks to pay a fee or limit their bank card issuing activities.

309    In that regard, even if paragraphs 84 and 85 of the judgment in CB v Commission, cited in paragraph 41 above (EU:C:2014:2204), may be read as meaning that the alteration of the structure of the market is a condition sine qua non for finding a restriction by object, the agreement at issue affected the structure of the market concerned, since it was intended to delay the applicants’ entry to that market, thus allowing Lundbeck to retain high prices for Cipramil and to ensure favourable conditions for the launch of Cipralex, which was supposed to replace Cipramil in the treatment of numerous patients (see paragraphs 11 and 130 above).

310    Consequently, the Commission was entitled, in the contested decision, to apply by analogy the BIDS judgment, cited in paragraph 254 above (EU:C:2008:643), and therefore the applicants’ present argument must be rejected.

–       The lack of precedents and the absence of legal certainty

311    The applicants submit that the contested decision is the first case in which the Commission has dealt with agreements providing for reverse payments.

312    In that context, they refer to a press release from KFST dated 28 January 2004 (‘the KFST press release’), which, in their submission, shows that the Commission considered that the agreements in question were in a grey area; that is, in their view, incompatible with the characteristics inherent in all restrictions by object.

313    The Commission disputes the applicants’ arguments.

314    It must be noted that, well before the date of conclusion of the agreement at issue, the Court had ruled on the application of competition law in fields characterised by the presence of intellectual property rights.

315    In that regard, it is true that the Court of Justice has acknowledged that the specific purpose of industrial property is, inter alia, to ensure that the patentee, in order to reward the creative effort of the inventor, has the exclusive right to use an invention with a view to manufacturing industrial products and putting them into circulation for the first time, either directly or by the grant of licences to third parties, as well as the right to oppose infringements (judgment of 31 October 1974 in Centrafarm and de Peijper, 15/74, ECR, EU:C:1974:114, paragraph 9). However, it has also established that, although the existence of rights recognised under the industrial property legislation of a Member State is not affected by Article 101 TFEU, the conditions under which those rights may be exercised may nevertheless fall within the prohibitions contained in that article. This may be the case whenever the exercise of such a right appears to be the object, the means or the consequence of an agreement, decision or concerted practice (see, to that effect, judgment in Centrafarm and de Peijper, EU:C:1974:114, paragraphs 39 and 40).

316    Likewise, the Court of Justice has established that although the Commission is not competent to determine the scope of a patent, it may not refrain from all action when the scope of the patent is relevant for the purposes of determining whether there has been an infringement of Articles 101 and 102 TFEU (judgment of 25 February 1986 in Windsurfing International v Commission, 193/83, ECR, EU:C:1986:75, paragraph 26). In the same judgment, the Court stated that the specific subject matter of the patent cannot be interpreted as also affording protection against actions brought in order to challenge its validity (judgment in Windsurfing International v Commission, EU:C:1986:75, paragraph 92).

317    Lastly, according to the case-law, an agreement is not exempt from competition law merely because it concerns a patent or is intended to settle a patent dispute (see paragraph 277 above).

318    Moreover, it must be noted that both Lundbeck and the Alpharma group were aware that their conduct was at least capable of posing problems from the point of view of competition law. As far as Lundbeck is concerned, it follows in particular from the email referred to in recital 188 of the contested decision that the conclusion of agreements with generic undertakings was considered ‘difficult’ from the point of view of competition law. As far as the Alpharma group is concerned, it follows from the Vice-President’s email (see paragraph 108 above) that an outline of the agreement at issue had been sent to an adviser with expertise in competition matters, which confirms that the group had asked itself whether its conduct was compatible with competition law.

319    Moreover, it is not necessary that the same type of agreement should have already been censured by the Commission in order for them to be considered a restriction of competition by object. The role of experience, mentioned by the Court of Justice in paragraph 51 of the judgment in CB v Commission, cited in paragraph 41 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 41 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).

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

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

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

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

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

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

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

327    The applicants’ present arguments must therefore be rejected.

–       United States case-law

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

329    The Commission disputes the applicants’ arguments.

330    These arguments must be rejected.

331    Even if the applicants’ reading of the Actavis judgment, cited in paragraph 328 above, is justified and the approach taken by the Commission in the contested decision is not consistent with that adopted by the US authorities, it has already been held that a position adopted by US law cannot take precedence over that adopted by EU law and that an infringement of US law does not constitute as such a defect resulting in the illegality of a decision adopted under EU law (see, to that effect, judgment of 30 September 2003 in Atlantic Container Line and Others v Commission, T‑191/98 and T‑212/98 to T‑214/98, ECR, EU:T:2003:245, paragraph 1407).

332    In any event, the judgment containing the majority opinion of the Supreme Court of the United States in the Actavis case (Actavis judgment, cited in paragraph 328 above) — and not the dissenting opinion of Judge Roberts — clearly establishes that the fact that an agreement falls within the scope of a patent does not exempt it from an antitrust action. As the concept of restriction by object does not exist in US law and is not equivalent to the ‘per se’ rule because of the possibility of justifying such a restriction under Article 101(3) TFEU, it is not correct to equate the ‘rule of reason’ under US law to the ‘effects’ test pursuant to Article 101(1) TFEU, as the applicants propose. Moreover, contrary to the applicants’ contention, the contested decision does not rely on presumptions, but on an analysis of the agreements, their content and their context, before concluding that they restrict competition by their very object.

333    In the light of all the foregoing considerations, the present plea must be rejected in its entirety.

 The fourth plea in law, alleging an error of law as regards the finding of the existence of a restriction by object when the agreement at issue reflects the exclusionary scope of Lundbeck’s patents

334    The applicants maintain that the agreement at issue could not restrict competition, even potential competition, since its scope was limited to the citalopram that infringed Lundbeck’s new patents, as follows from their first plea, and therefore coincided with the exclusionary scope of Lundbeck’s new patents. In that regard, they observe that any patent, including process patents, benefits from a presumption of validity which the Commission ignored or reversed.

335    The Commission disputes the applicants’ arguments.

336    First, it should be borne in mind that, following the examination of the first plea in law, it was concluded that the scope of the agreement at issue was as summarised in paragraph 244 above.

337    The applicants therefore have no grounds for maintaining that the consequences of that agreement coincide with those flowing from Lundbeck’s new patents. In particular, the parties to that agreement were of the view that the Matrix process did not infringe those patents.

338    Secondly, it must be noted that, in any event, Lundbeck, by the agreement at issue, received an assurance that the Alpharma group would not seek to enter the market with citalopram liable to infringe its new patents, whilst, if Lundbeck had chosen to block the group by actions based on its new patents, it would have not been certain of success.

339    In that regard, in the light of the principles deriving from the case-law set out in paragraphs 315 and 316 above, the presumption of validity enjoyed by all patents cannot be equated with a presumption of illegality of any product placed on the market which the patent holder deems to be infringing his 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 entry ‘at risk’ by a generic undertaking is not in itself unlawful. Moreover, in the context of an infringement action, the defendant could have challenged the validity of the patent on which Lundbeck relied by bringing a counter-claim. Such claims occur frequently in patent litigation and lead, in numerous cases, to a declaration of invalidity of the process patent relied on by the patent holder, as the Commission noted in recital 76 of the contested decision.

340    In the present case, as the examination of the second plea has made clear, such a strategy was precisely one of the real concrete possibilities available to the Alpharma group as an alternative to entering into the agreement at issue.

341    As regards the reference made by the applicants to the Guidelines on the application of Article [101 TFEU] to technology transfer agreements (OJ 2004 C 101, p. 2), it must be noted, as the Commission did in recital 677 of the contested decision, that these are not applicable to the present case, given that Lundbeck did not transfer any technology to the generic undertakings by means of the agreement at issue.

342    In any event, according to paragraph 32 of the Guidelines on the application of Article 101 TFEU to technology transfer agreements, the guidelines refer to the possibility of authorising an agreement if a blocking position actually exists, on the basis of objective factors which the parties to a technology transfer agreement must produce, and not on the basis of a presumption. Such a blocking position did not exist in the present case since the Alpharma group had real concrete possibilities of entering the market.

343    Finally, as regards the argument which the applicants seek to base on the judgment of 16 December 1999 in Micro Leader v Commission (T‑198/98, ECR, EU:T:1999:341), the context of that case was very different from that of the present case. The Court had to ascertain whether the Commission was justified in rejecting the applicant’s complaint alleging that the conduct of the companies Microsoft France and Microsoft Corporation seeking to prevent the importation into France of Microsoft software marketed in Canada was contrary to Articles 101 and 102 TFEU. The Court therefore had to determine whether the Commission had considered with sufficient care the factual and legal matters put forward by the applicant, in order to assess whether those matters were indicative of anticompetitive conduct (see, to that effect, judgment in Micro Leader v Commission, EU:T:1999:341, paragraphs 1, 7 and 27).

344    That was the context in which the Court held that it could not be inferred from the evidence set out by the applicant that Microsoft Corporation’s decision to prohibit the importation and resale in France of French-language software marketed in Canada had been taken in the framework of an agreement or concerted practice with its distributors in Canada, the object of which was to partition the markets (see, to that effect, judgment in Micro Leader v Commission, cited in paragraph 343 above, EU:T:1999:341, paragraph 33).

345    Similarly, the Court stated that, even if Microsoft Corporation had in fact restricted in that way the opportunities for Canadian distributors to sell their products outside Canada, it would merely have been enforcing the copyright it held over its products under Article 4(c) of Council Directive 91/250/EEC of 14 May 1991 on the legal protection of computer programs (OJ 1991 L 122, p. 42), given that the marketing in Canada of copies of Microsoft Corporation’s software did not exhaust its copyright (see, to that effect, judgment in Micro Leader v Commission, cited in paragraph 343 above, EU:T:1999:341, paragraph 34).

346    It is apparent from that summary that, in view of the specific circumstances of the case that gave rise to that judgment, the Court was not required to rule on whether there was any uncertainty concerning whether the intellectual property right in question enabled its holder to obtain, through an enforcement action, the same result as that obtained by means of the conduct complained of. Nor was the Court required to state its view on the consequences which such uncertainty could have had with regard to whether an infringement of competition law existed. By contrast, as can be seen in particular from paragraphs 336 to 340 above, the Alpharma group and Lundbeck were faced with such uncertainties and preferred to exchange them for certainties, by concluding the agreement at issue.

347    Accordingly, the applicants cannot derive any useful argument from the judgment which they invoke.

348    In view of all the foregoing considerations, the fourth plea in law must be rejected.

 The fifth plea in law, alleging breach of the rights of the defence

349    The applicants maintain that the Commission irremediably compromised their rights of defence by failing to inform them in a timely manner of the existence of an investigation concerning them and of its objections regarding them. Although it learned of the agreement at issue in 2003, the Commission did not contact Zoetis in this connection until 19 March 2010 and contacted Xellia only on 14 March 2011. The statement of objections dates only from 24 July 2012.

350    Owing to the excessive time that elapsed, the applicants claim that they no longer had exculpatory evidence, such as drafts of, and comments on, the agreement at issue, citalopram business plans, explanations and testimony of the staff employed by them at the material time who were involved in the case and exchanges with their outside counsel, who destroyed the file relating to the applicants in 2007, in accordance with the regulations of the Danish Law Society. They submit that this is not simply a matter of a few lost documents but concerns instead all the essential documents for their defence.

351    They further submit that they were under no heightened duty to retain the documents, since they were unaware that they were under investigation.

352    The Commission disputes the applicants’ arguments.

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

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

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

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

357    In that regard, it has been held that the excessive duration of the first phase may have an effect on the future ability of the undertakings concerned to defend themselves, in particular by reducing the effectiveness of the rights of the defence where they are relied on in the second phase, owing to the passage of time and the resulting difficulty in obtaining exculpatory evidence. It is necessary, however, in such a case, for the undertakings concerned to demonstrate in a sufficiently precise manner that they experienced difficulties in defending themselves against the Commission’s claims, specifying the documents or testimonies that they could no longer obtain and the reasons why that was capable of compromising their defence (see, to that effect, judgments in Technische Unie v Commission, cited in paragraph 356 above, EU:C:2006:593, paragraphs 54 and 60 to 71, and of 29 March 2011 in ArcelorMittal Luxembourg v Commission and Commission v ArcelorMittal Luxembourg and Others, C‑201/09 P and C‑216/09 P, ECR, EU:C:2011:190, paragraph 118).

358    Similarly, according to the case-law, those undertakings must indicate in detail, if not the specific items of evidence that have disappeared, at least the incidents, events or circumstances which prevented them, during the period in question, from complying with their obligation of diligence and brought about the alleged disappearance of the evidence alluded to. Only by examining such specific indications can the European Union judicature assess whether an undertaking has shown to the requisite legal standard that it experienced the alleged difficulties in defending itself against the Commission’s claims as a result of the excessive length of the administrative procedure, or whether, instead, those difficulties in fact derive from a failure to comply with its obligation of diligence (judgment in ArcelorMittal Luxembourg v Commission and Commission v ArcelorMittal Luxembourg and Others, cited in paragraph 357 above, EU:C:2011:190, paragraphs 120 to 122).

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

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

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

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

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

–        in January 2008, the Commission decided to launch a sector inquiry into the pharmaceutical sector, which was closed with the adoption of a final report on 8 July 2009 (see paragraphs 22 and 23 above);

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

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

–        on 19 March 2010, the Commission informed Alpharma Inc. (see paragraph 3 above) of the existence of the investigation;

–        on 14 March 2011, it provided Xellia with the same information;

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

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

361    It must be observed that the first phase began, in respect of Zoetis, on 19 March 2010 and, in respect of Xellia, on 14 March 2011, when the Commission took the initial measures implying an accusation of infringement, and was closed on 24 July 2012, the date of the statement of objections. Such periods are not unreasonable.

362    First, in so far as the applicants base their plea on the date on which the Commission first became aware of the agreement at issue in order to establish that the Commission failed to fulfil its obligation to adopt a decision within a reasonable period and thus infringed their rights of defence, it must be stressed that nowhere is that approach followed in the case-law, which takes as its starting point the date of the initial measures implying an accusation of infringement (see, to that effect, judgment in Technische Unie v Commission, cited in paragraph 356 above, EU:C:2006:593, paragraph 43).

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

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

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

366    Thirdly, as regards the KFST press release, which suggested, according to the applicants, that the Commission would not initiate any proceedings against the Alpharma group, it must be observed that, in the light of the considerations set out in paragraphs 320 to 325 above in that regard, the applicants cannot reasonably claim that such a press release encouraged them not to take measures to defend themselves, still less that such encouragement, if established, would be attributable to the Commission and the excessive duration of the administrative proceedings before it.

367    Fourthly, the Court notes that the applicants merely put forward in support of their argument the loss of three categories of documents, namely drafts and comments relating to the agreement at issue (for example the draft mentioned in the email of 20 February 2002), citalopram business plans and documents of outside counsel.

368    In that regard, even if the applicants’ claims fulfilled the conditions of precision and specificity required by the case-law referred to in paragraph 357 above, it must be stated that, in view of the KFST press release and the sector inquiry opened by the Commission, a diligent undertaking should have retained — at least until the expiry of the maximum limitation period prescribed by EU law (see paragraph 363 above) — any documents that might prove useful in its defence in the event of proceedings being initiated in respect of an infringement of competition law.

369    Diligence is among the conditions which the case-law (see paragraph 358 above) requires a party to meet in order to be able successfully to plead infringement of its rights of defence owing to the allegedly unreasonable length of the proceedings.

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

371    As regards more particularly the documents of the Alpharma group’s external counsel, which that counsel destroyed in 2007 in accordance with the regulations of the Danish Law Society, the Court observes that the applicants have not provided further particulars concerning those regulations and that, in any event, had they been diligent, they could themselves have kept copies of those documents.

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

373    Moreover, assuming that the present plea may be interpreted as also requesting the Court to reduce the amount of the fine imposed on the applicants even in the absence of an illegality justifying the annulment of the contested decision, it should be recalled that the review of legality of decisions adopted by the Commission is supplemented by the unlimited jurisdiction which the Courts of the European Union are 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).

374    It is therefore for the Court, in the exercise of its unlimited jurisdiction, to assess, on the date on which it adopts its decision, whether the fine imposed on the applicant was one whose amount properly reflects the gravity and duration of the infringement in question (judgments in InnoLux v Commission, cited in paragraph 373 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).

375    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).

376    In the present case, even if it were considered that the case-law of the Court of Justice (see, to that effect, judgment of 8 May 2014 in Bolloré v Commission C‑414/12 P, EU:C:2014:301, paragraphs 106 and 107) could be interpreted as not precluding the Court, in the exercise of its unlimited jurisdiction, from reducing a fine in order to censure solely an infringement of the rights of the defence, it must be noted that the Commission has already taken into account the duration of the administrative proceedings and has accordingly granted a 10% reduction in the amount of the fines imposed on the applicants and other addressees of the contested decision (see paragraph 36 above).The Court therefore considers, in the exercise of its unlimited jurisdiction, that it is not in any event appropriate further to reduce the amount of the fine for which the applicants are liable.

377    In the light of the foregoing considerations, the present plea in law must also be rejected in so far as concerns the exercise of unlimited jurisdiction.

 The sixth plea in law, alleging breach of the principle of non-discrimination owing to the fact that Zoetis is an addressee of the contested decision

378    The applicants maintain that the Commission breached the principle of non-discrimination, since, as regards the infringement committed by the Alpharma group, it considered that both Zoetis, in its capacity as intermediate parent company of the company that signed the agreement at issue, and A.L. Industrier, in its capacity as the ultimate parent company of the undertaking concerned, were liable for the infringement, while, in the case of another of the agreements in question, namely the agreement concluded between Lundbeck and Generics UK Ltd, which belonged to the Merck group, only the ultimate parent company of that group, Merck KGaA, was held liable, and not also the intermediate parent company, Merck Generics Holding GmbH.

379    The Commission contends that, even if the principle of non-discrimination is applicable in relation to the imputation of an infringement to intermediate holding companies, in the present case the different treatment of Zoetis and Merck Generics Holding was justified. At the time when the contested decision was adopted, Merck still controlled Merck Generics Holding, whereas A.L. Industrier no longer controlled Zoetis.

380    In that regard, it should be recalled that, when the amount of the fine is determined, there cannot, by the application of different methods of calculation, be any discrimination between the undertakings which have participated in the same infringement of Article 101 TFEU (see judgment of 12 November 2014 in Guardian Industries and Guardian Europe v Commission, C‑580/12 P, EU:C:2014:236, paragraph 62 and the case-law cited).

381    Similarly, when the Commission adopts, in respect of one agreement, decision or concerted practice and within the framework set by the case-law, one specific method for the determination of the responsibility of the parent companies concerned for the infringements of their subsidiaries, there cannot, by the application of a different method for determining that responsibility, be any discrimination between the parent companies whose subsidiaries have participated in that agreement, decision or concerted practice (see judgment in Bolloré v Commission, cited in paragraph 376 above, EU:C:2014:301, paragraph 93 and the case-law cited).

382    It is true that, in the judgment of 13 July 2011 in ThyssenKrupp Liften Ascenseurs v Commission (T‑144/07, T‑147/07 to T‑150/07 and T‑154/07, ECR, EU:T:2011:364, paragraph 119), to which the Commission refers, it was held that the possibility of imposing a penalty on the ultimate parent company for its subsidiary’s unlawful conduct does not mean that an intermediate holding company or the subsidiary itself may not be penalised, provided that the Commission was entitled to regard those companies as forming a single undertaking. Thus, in such case, the Commission may, if the conditions governing imputation are met, choose to penalise the subsidiary which participated in the infringement, the intermediate parent company which controlled it during the period concerned and the ultimate parent company of the group.

383    However, in the case that gave rise to the judgment in ThyssenKrupp Liften Ascenseurs v Commission, cited in paragraph 382 above (EU:T:2011:364), the Court did not rule on whether the principle of non-discrimination applied when the Commission chose to impose a fine not only on the companies that had participated in the infringements found and their ultimate parent companies, but also on companies which occupied a position between those companies in the structure of each undertaking concerned.

384    Applying that principle in the present case therefore does not conflict with the judgment in ThyssenKrupp Liften Ascenseurs v Commission, cited in paragraph 382 above (EU:T:2011:364).

385    Consequently, it is necessary to determine whether the Commission infringed the principle of non-discrimination by addressing the contested decision not only to A.L. Industrier and Xellia, but also to Zoetis, when it did not address it to Merck Generics Holding.

386    For that purpose, in the first place it should be recalled that that principle requires that comparable situations must not be treated differently and different situations must not be treated in the same way unless such treatment is objectively justified (see judgment of 14 September 2010 in Akzo Nobel Chemicals and Akcros Chemicals v Commission, C‑550/07 P, ECR, EU:C:2010:512, paragraph 55 and the case-law cited).

387    In the second place, it must be stated that, during the relevant period, Alpharma ApS, Alpharma Inc. and A.L. Industrier formed a single undertaking, whilst that was no longer the case at the time of the adoption of the contested decision. In fact, at that point, Xellia, which was the successor to Alpharma ApS, Zoetis, which was the successor to Alpharma Inc., and A.L. Industrier each formed part of different undertakings, as is clear from recitals 50 to 52 and 1269 to 1275 of the contested decision.

388    In that regard, contrary to the applicants’ contention, it is immaterial that, in recital 1272 of the contested decision, the Commission defined Alpharma Inc. as the ‘parent company’ of Alpharma ApS rather than as the intermediate holding company.

389    It is clear from the contested decision, in particular from recitals 43, 1275, 1284 and 1286, that the Commission held that A.L. Industrier, which controlled Alpharma Inc., formed with that company a single undertaking that also included Alpharma ApS. Moreover, the applicants do not dispute that those three companies formed a single undertaking at the time of the conclusion of the agreement at issue.

390    As regards the Merck group, it follows from the contested decision (footnote No 31) that Generics UK, which was the company that entered into the two agreements in question with Lundbeck, was, during the period covered by those agreements, controlled by Merck Generics Holding, which was in turn controlled by Merck. The contested decision also explains that, in 2007, Generics UK was sold to another undertaking, with the result that it left the Merck group (recital 33).

391    However, it follows from the Commission’s answer to a question put by the Court and from a document produced by the Commission on the same occasion that, at the time of the adoption of the contested decision, Merck and Merck Generics Holding still formed part of the same undertaking. Although, as the applicants submit, that fact was not mentioned in the contested decision, the Court notes that the document in question is part of the Commission’s administrative file and was accordingly available to the Commission when it adopted that decision.

392    Furthermore, it should be observed that, in view of the financial situation of A.L. Industrier, the Commission was wholly justified in holding Zoetis jointly and severally liable for the infringement committed by Xellia, since, otherwise, Xellia alone would have been liable for almost the entirety of the fine related to the infringement committed by the Alpharma group, which would have made it less certain that the fine would have been paid. By contrast, as long as Merck controls Merck Generics Holding, the financial resources of the latter may be used to pay the fine imposed on the Merck group, without it being essential for that purpose to refer to it in the operative part of the contested decision.

393    Finally, as regards the applicants’ argument that the Commission does not have authority so far as concerns the so-called ‘internal’ allocation of liability as between those held jointly and severally liable, it is certainly consistent with the case-law (see, to that effect, judgment of 10 April 2014 in Areva and Others v Commission, C‑247/11 P and C‑253/11 P, ECR, EU:C:2014:257, paragraphs 152 and 158), but it is ineffective given that it is not capable of calling into question the reasoning set out in paragraphs 387 to 392 above.

394    In view of the foregoing, the present plea must be rejected and there is no need to rule on whether it is admissible even though it is contrary to Xellia’s interests.

 The seventh plea in law, alleging errors affecting the calculation of the amount of the fine imposed on the applicants

395    The applicants maintain that the Commission made six errors affecting the calculation of the fine which it imposed on them.

 The gravity of the infringement alleged against the applicants

396    The applicants maintain that the Commission failed to take account of what they claim is the limited gravity of the infringement found in the contested decision, which was classified as ‘serious’ and not as ‘very serious’, as it was in the statement of objections. That change was not reflected in the basic amount of the fine.

397    The Commission disputes the applicants’ arguments.

398    It should be recalled that, as is apparent from the examination of the second and third pleas in law, the agreement at issue is a restriction of competition by object, given that Lundbeck paid the Alpharma group, which was a potential competitor, so that the latter would accept limitations on its conduct in the market during the relevant period. Thus, the Commission had no reason to consider that the gravity of the infringement committed by Lundbeck and the Alpharma group was limited.

399    So far as the applicants’ reference to the statement of objections is concerned, suffice it to note, as the Commission does, that the applicants are incorrect when they state that the statement of objections had set the basic amount of the fine at EUR 11.7 million. In the statement of objections the Commission had neither mentioned nor set any basic amount in respect of the Alpharma group but had merely specified the elements that the Commission intended to take into account in setting the fines for the generic undertakings concerned, as is apparent from recital 856 of the statement of objections. The amounts of the payments made by Lundbeck to those undertakings were simply mentioned in the context of the need to ensure the deterrent effect of the fines and, where appropriate, to increase the fines in order to exceed the amounts of the payments made by Lundbeck.

400    It follows that the present arguments cannot succeed.

 Legal uncertainty

401    The applicants submit that the Commission failed to take into consideration the legal uncertainty that existed concerning the evaluation of the agreements in question in the light of competition law.

402    The Commission disputes the applicants’ arguments.

403    It should be recalled that, according to the case-law, the principle that penalties must have a proper legal basis and the principle of legal certainty cannot be interpreted as prohibiting the gradual clarification of the rules of liability but may preclude the retroactive application of a new interpretation of a rule establishing an offence. That is particularly true of a judicial interpretation which produces a result that was not reasonably foreseeable at the time when the offence was committed, especially in the light of the interpretation put on the provision in the case-law at the material time (see judgment in Telefónica and Telefónica de España v Commission, cited in paragraph 74 above, EU:C:2014:2062, paragraphs 147 and 148 and the case-law cited).

404    In that regard, it follows from the case-law that the scope of what is foreseeable depends to a considerable degree on the content of the text at issue, the field which it covers and the number and status of those to whom it is addressed, and that a law may still satisfy the requirement of foreseeability even if the person concerned has to take appropriate legal advice to assess, to a degree that is reasonable in the circumstances, the consequences which a given action may entail (judgment of 28 June 2005 in Dansk Rørindustri and Others v Commission, C‑189/02 P, C‑202/02 P, C‑205/02 P to C‑208/02 P and C‑213/02 P, ECR, EU:C:2005:408, paragraph 219).

405    Moreover, with regard to whether an offence was committed intentionally or negligently and is therefore liable to be penalised by the imposition of a fine in accordance with the first subparagraph of Article 23(2) of Regulation No 1/2003, it is settled case-law that that condition is satisfied where the undertaking concerned cannot be unaware of the anticompetitive nature of its conduct, whether or not it is aware that it is infringing the competition rules of the Treaty (see judgment in Schenker & Co. and Others, cited in paragraph 321 above, EU:C:2013:404, paragraph 37 and the case-law cited).

406    In the present case, it follows from the examination of the third plea in law (see in particular paragraphs 314 to 318 above) that there was no legal uncertainty regarding the possibility of classifying as a restriction by object an agreement which had the characteristics of the agreement at issue and which came about in the context of that agreement.

407    Since the Alpharma group was not unaware that conclusion of the agreement at issue might be problematic from the perspective of competition law, the present arguments must be rejected.

 The geographic scope of the infringement alleged against the applicants

408    According to the applicants, the Commission failed to prove that the geographic scope of the infringement at issue extended throughout the EEA.

409    The Commission disputes the applicants’ arguments.

410    It must be observed that, as follows from the email of 19 February 2002, at the time when the agreement at issue was concluded, the Alpharma group was preparing for market entry in numerous countries although not in all those covered by the definition of ‘Territory’ set out in the second recital in the preamble (see the second indent of paragraph 15 above).

411    However, the obligations which that group accepted in exchange for Lundbeck’s payments concerned the ‘Territory’, the definition of which was set out in the second recital in the preamble, so that the geographic scope of the restriction by object censured by the contested decision extends to that territory as a whole.

412    In that regard, as the Commission, in recital 1365 of the contested decision, correctly pointed out, since the case involved a restriction of competition by object, it is irrelevant, for the purpose of establishing the gravity of that restriction, in which countries the agreement at issue produced effects.

413    The present arguments must therefore be rejected.

 The determination of the basic amount

414    The applicants object to the fact that the basic amount of their fine corresponds to 100% of the value of Lundbeck’s payments to the Alpharma group, which are considered to correspond to the value of expected sales of its generic citalopram, whereas in Lundbeck’s case only a small proportion, between 10 and 11%, of the value of its sales of citalopram was taken into account.

415    In that connection, they point first to the fact that the Alpharma group incurred costs, some of which can no longer be proved because of the unreasonable length of the Commission’s investigation. Secondly, they maintain that the only improper gains arising from the agreement at issue are those which exceed the profits which the Alpharma group would have made in the case of market entry.

416    The Commission disputes the applicants’ arguments.

417    It should be recalled that, as was observed in paragraph 33 above, the Commission used two different methods to calculate, first, the amount of the fine to be imposed on Lundbeck and, secondly, the amount of the fines to be imposed on the generic undertakings, including the Alpharma group.

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

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

420    The method applied to the Alpharma group therefore consisted in using as the basic amount the value of the payments which it had received from Lundbeck, that is to say, EUR 11.7 million.

421    In view of the lack of sales on the market by the Alpharma group, it cannot seriously be disputed that the Commission was obliged to depart from the general methodology. Moreover, the applicants do not criticise the Commission for not having taken as its basis the value of citalopram sales by the Alpharma group.

422    Instead, first, they object to the fact that the Commission took as a basic amount the total value of those payments, rather than a proportion of them, as it did, following the general methodology, as regards the value of Lundbeck’s sales.

423    In that regard, it should be noted that there are fundamental differences between the general methodology and that which the Commission applied to the generic undertakings.

424    Indeed, in the case of the general methodology, the objective of taking into account the value of sales as provided for in point 13 of the 2006 Guidelines is to adopt as the starting point for the setting of the fine to be imposed on an undertaking an amount which reflects the economic significance of the infringement and the relative size of the undertaking’s contribution to it (see, to that effect, judgment of 23 April 2015 in LG Display and LG Display Taiwan v Commission, C‑227/14 P, ECR, EU:C:2015:258, paragraph 53 and the case-law cited). Thereafter, pursuant to points 19 and 21 of those guidelines, the Commission, according to the gravity of the infringement, will set the proportion of that value of sales to be used for determining the basic amount. That proportion may, as a rule, be set at up to 30% and must be multiplied by a coefficient based on the duration of the infringement, in accordance with point 24 of the 2006 Guidelines. Next, pursuant to point 25 of the guidelines, irrespective of the duration of the undertaking’s participation in the infringement, the Commission will include in the basic amount a sum of between 15 and 25% of the value of sales in order to deter undertakings from entering into horizontal price-fixing, market-sharing and output-limitation agreements, or even other infringements.

425    However, the method adopted with regard inter alia to the Alpharma group does not provide for all those stages, given that the Commission used directly as a basic amount the value of the payments made by Lundbeck.

426    It is true that, in inter alia recitals 528 and 1071 of the contested decision, the Commission stated that those payments roughly matched the resale value of the tablets which the Alpharma group had already received or ordered at the time the agreement at issue was concluded. That does not mean, however, that the Commission was obliged, with regard to the group, to use the value of those payments as an estimate of the value of sales for the purposes of point 13 of the 2006 Guidelines and subsequently to apply to that value the various stages provided for by the general methodology.

427    It must also be noted that the Commission applied the same method to all the generic undertakings that were addressees of the contested decision and accordingly complied with the principle of equal treatment.

428    Secondly, the applicants complain that the Commission took into account the total amount of the payment made by Lundbeck to the Alpharma group without deducting the costs which the latter had incurred in preparing its market entry, or at the least the purchase price of the citalopram tablets which it had received or ordered, namely EUR 3.7 million.

429    On that point, the Court notes that the purpose of a fine is not simply to remove the benefits that an undertaking has obtained through its anticompetitive conduct, but also to deter that undertaking and other undertakings from engaging in such conduct. Thus, even assuming that, in not deducting the costs in question from the amount of EUR 11.7 million, the Commission imposed a fine which exceeded the net gain for the Alpharma group from the agreement at issue, that fine would nonetheless not be disproportionate. Furthermore, as the Commission stated in recital 1371 of the contested decision, the costs which that group had incurred were related to market entry rather than to conclusion of the agreement at issue; there was consequently no direct link between those costs and the amount of Lundbeck’s payments (see paragraph 297 above).

430    Finally and in any event, it should be observed that, as the fifth plea in law has been rejected, the applicants are unfounded in their contention that the duration of the procedure did not allow them to quantify the other costs incurred by the Alpharma group.

431    Thirdly, the applicants maintain that the Commission should have deducted from the amount of EUR 11.7 million the profits which the Alpharma group would have made had it entered the market.

432    In that regard, it is appropriate to refer to the reasoning set out in paragraph 429 above. Moreover, it must be borne in mind that the payments arising under the agreement at issue were certain, whilst the profits that might have resulted from market entry were subject to the vagaries of a commercial operation of that kind.

433    In view of the foregoing observations, the applicants’ present arguments must be rejected.

 The possibility of reducing the fine owing to the existence of Lundbeck’s new patents

434    The applicants submit that, if the Court should consider that the agreement at issue is an infringement by object only in so far as its scope exceeds that of the restrictions inherent in Lundbeck’s new patents, their fine should be reduced by excluding from the basic amount the USD 11 million corresponding to Lundbeck’s purchase of the infringing citalopram tablets received or ordered by the Alpharma group.

435    The Commission disputes the applicants’ arguments.

436    It must be recalled that, in the examination of the third and fourth pleas in law, it was established (i) that Lundbeck’s new patents did not prevent the Alpharma group being characterised as a potential competitor to Lundbeck and (ii) that the agreement at issue is a restriction by object irrespective of the existence of those patents and of whether or not the scope of that agreement exceeded that of those patents (see, in particular, paragraphs 338 and 339 above).

437    Therefore the premiss on which the applicants’ present arguments are based is unfounded. It must also be observed that Lundbeck did not buy the tablets which the Alpharma group had already received or ordered from Tiefenbacher at the purchase price but at a much higher price.

438    In those circumstances, the present arguments cannot succeed.

 The exchange rate used by the Commission

439    In the applicants’ submission, in order to ensure that they were not penalised unnecessarily, the Commission ought to have applied the current dollar/euro exchange rate, since the euro strengthened significantly during the unreasonably long investigation.

440    The Commission disputes the applicants’ arguments.

441    It must be noted that, as the Commission correctly observes, the exchange rate applicable at the time of the events in question is the exchange rate which best reflects the value of the amount paid by Lundbeck at that time.

442    The length of the procedure which, moreover, is not unreasonable, as the rejection of the fifth plea shows, does not cast doubt on that observation.

443    Therefore, this argument must be rejected, as must, in consequence, the seventh plea in law in its entirety.

 The eighth plea in law, alleging a manifest error of assessment in relation to the maximum amount of the fine in respect of which A.L. Industrier is jointly and severally liable

444    The applicants maintain that, when it applied to A.L. Industrier the maximum amount provided for in the second subparagraph of Article 23(2) of Regulation No 1/2003 (see paragraphs 37 and 38 above), the Commission made an error in using the turnover achieved by that company in 2011 instead of its significantly higher 2012 turnover. They submit that 2012 must be regarded as a full year of normal economic activity for the purpose of applying that provision.

445    According to the applicants, that error penalised them, since, as a result of it, A.L. Industrier is jointly and severally liable for only a very small share of the fine which the Commission imposed on account of the infringement committed by the Alpharma group and since the major part of that fine must be paid solely by the applicants.

446    The Commission disputes the applicants’ arguments.

447    In the first place, it should be recalled that the second subparagraph of Article 23(2) of Regulation No 1/2003 provides:

‘For each undertaking and association of undertakings participating in the infringement, the fine shall not exceed 10% of its total turnover in the preceding business year.’

448    In the second place, it follows from the case-law that, if several addressees of a Commission decision imposing a fine for an infringement of competition law constituted the undertaking which committed that infringement at the date when the decision was adopted, the 10% ceiling provided for in Article 23(2) of Regulation No 1/2003 (‘the ceiling’) can be calculated on the basis of the overall turnover of that undertaking. By contrast, if, as in the present case, that economic entity has been split to form several separate entities at the time when the decision is adopted, each addressee of that decision is entitled to have the ceiling applied individually to it (judgment of 24 March 2011 in Comap v Commission, T‑377/06, ECR, EU:T:2011:108, paragraph 111; see also, to that effect, judgments of 4 September 2014 in YKK and Others v Commission, C‑408/12 P, ECR, EU:C:2014:2153, paragraph 59, and 15 June 2005 in Tokai Carbon and Others v Commission, T‑71/03, T‑74/03, T‑87/03 and T‑91/03, EU:T:2005:220, paragraph 390).

449    In the third place, the case-law has also made clear that, for the purposes of calculating the ceiling, the Commission must, in principle, take into account the turnover achieved by the undertaking concerned in the last full business year at the date of adoption of the decision imposing the fine. It is apparent, however, from the context and the objectives pursued by the legislation in question, that where the turnover in the business year preceding the adoption of the Commission’s decision does not represent a full year of normal economic activity over a period of 12 months and, thus, does not provide any useful indication as to the actual economic situation of the undertaking concerned and the appropriate level of fine to impose on it, that turnover cannot be taken into account in determining the ceiling. In the latter situation, which will arise only in exceptional circumstances, the Commission is obliged, for the purposes of calculating the ceiling, to refer to the last full business year corresponding to a full year of normal economic activity (see judgment of 12 December 2012 in 1. garantovaná v Commission, T‑392/09, EU:T:2012:674, paragraph 86 and the case-law cited).

450    In the present case, those principles are not disputed but the parties disagree on whether 2012 was a year of normal economic activity for A.L. Industrier.

451    In that regard, it should be noted that, in recitals 1386 and 1387 of the contested decision, the Commission observed, referring to A.L. Industrier’s annual report for 2012, that in 2012 that company was in the process of winding down its assets, which would lead to a decrease of its turnover to zero. The Commission concluded that 2012 was not a year of normal business activity.

452    It must be noted that, as the Commission points out in its written answer to a question put by the Court, the selling off of a company’s assets, although it may entail an increase in its income, does not represent normal business activity but is designed to convert those assets into cash with a view to distributing it to the shareholders (see, to that effect, 1. garantovaná v Commission, cited in paragraph 449 above, EU:T:2012:674, paragraphs 99 and 105).

453    It is true that, as the applicants maintain on the basis of the annual report mentioned in paragraph 451 above, the sale of A.L. Industrier’s assets was not completed in 2012 and the funds realised from that sale were not immediately distributed to the shareholders because of the uncertainty generated by the statement of objections, which was also addressed to A.L. Industrier.

454    However, those circumstances do not call into question the fact that, in the course of 2012, A.L. Industrier had sold its principal asset, A.L. Eiendomsutvikling AS, which did not represent normal business activity.

455    As to the fact that the profits deriving from that sale were not immediately distributed to the shareholders, that shows a degree of prudence on the part of the board of A.L. Industrier but nonetheless does not suffice to render 2012 a year of normal business activity.

456    The Commission was therefore justified in not calculating the ceiling applicable to A.L. Industrier on the basis of its 2012 turnover.

457    In their written reply to a question put by the Court, the applicants argued that the Commission should have taken as its basis A.L. Industrier’s 2005 turnover, since, thereafter, that company no longer controlled the Alpharma group and was no longer active in the pharmaceutical sector, which drastically reduced its turnover.

458     It must be observed in that regard, that, according to the case-law, the objective sought by the establishment, in Article 23(2), of a limit of 10% of the turnover of each undertaking participating in an infringement is, inter alia, to ensure that the imposition of a fine higher in amount than that limit should not exceed the capacity of an undertaking to make payment at the time when it is identified as responsible for the infringement and a financial penalty is imposed on it by the Commission (judgment in YKK v Commission, cited in paragraph 448 above, EU:C:2014:2153, paragraph 63; see also, to that effect, judgments in Tokai Carbon and Others v Commission, cited in paragraph 448 above, EU:T:2005:220, paragraph 389, and of 16 November 2011 in Kendrion v Commission, T‑54/06, EU:T:2011:667, paragraph 91).

459    Consequently, the Commission, after deciding that the ceiling applicable to A.L. Industrier could not be set on the basis of 2012 — that is to say, the year immediately preceding that in which the contested decision was adopted — could not go back as far as 2005 but had to use the turnover of the last year preceding 2012 in which A.L. Industrier’s business activities had been normal, irrespective of the sectors in which that company was active.

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

 Costs

461    Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicants have been unsuccessful, they must be ordered to pay 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 Xellia Pharmaceuticals ApS and Alpharma LLC to pay the costs.

Delivered in open court in Luxembourg on 8 September 2016.

[Signatures]

Table of contents

Background to the dispute

The companies involved in the present case

The relevant product and the applicable patents

Agreement entered into by Lundbeck with the Alpharma group and other matters relating to the background

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

Contested decision

Procedure and forms of order sought

Law

The second plea in law, alleging errors of law and of assessment as regards the characterisation of the Alpharma group as a potential competitor

Analysis relating to potential competition in the contested decision

Applicable principles and case-law

– Potential competition

– The burden of proof

– The extent of the Court’s review

The first part

The second part

– The Alpharma group’s ability to enter the market with the tablets that it had already received or ordered

– The Alpharma group’s ability to enter the market with citalopram produced using the Matrix process

The first plea in law, alleging a manifest error of assessment as regards the Commission’s interpretation of the scope of the agreement at issue

Interpretation of the agreement at issue

– The wording of Article 1.1

– The preamble

– Certain circumstances relating to the conclusion of the agreement at issue

– The consent order of 2 May 2002

– Certain documents of which the Commission did not take due account

– The date of the Alpharma group’s market entry

Conclusions on the scope of the obligations entered into by the Alpharma group

The third plea in law, alleging a manifest error of assessment in the characterisation of the agreement at issue as a restriction of competition by object

Preliminary observations

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

The existence of a restriction by object in the present case

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

– Lack of certainty as regards the outcome of a potential patent dispute

– The amounts of the payments made by Lundbeck

– Analogies with the case giving rise to the BIDS judgment

– The lack of precedents and the absence of legal certainty

– United States case-law

The fourth plea in law, alleging an error of law as regards the finding of the existence of a restriction by object when the agreement at issue reflects the exclusionary scope of Lundbeck’s patents

The fifth plea in law, alleging breach of the rights of the defence

The sixth plea in law, alleging breach of the principle of non-discrimination owing to the fact that Zoetis is an addressee of the contested decision

The seventh plea in law, alleging errors affecting the calculation of the amount of the fine imposed on the applicants

The gravity of the infringement alleged against the applicants

Legal uncertainty

The geographic scope of the infringement alleged against the applicants

The determination of the basic amount

The possibility of reducing the fine owing to the existence of Lundbeck’s new patents

The exchange rate used by the Commission

The eighth plea in law, alleging a manifest error of assessment in relation to the maximum amount of the fine in respect of which A.L. Industrier is jointly and severally liable

Costs

* Language of the case: English.

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