JUDGMENT OF THE GENERAL COURT (Ninth Chamber)

8 September 2016 ( 1 )

‛Competition — Agreements, decisions and concerted practices — Market for antidepressant medicinal products containing the active pharmaceutical ingredient citalopram — Concept of restriction of competition ‘by object’ — Potential competition — Generic medicinal products — Barriers to market entry resulting from the existence of patents — Agreements concluded between a patent holder and generic undertakings — Article 101(1) and (3) TFEU — Errors of law and of assessment — Obligation to state reasons — Rights of defence — Legal certainty — Fines’

In Case T‑472/13,

H. Lundbeck A/S, established in Valby (Denmark),

and

Lundbeck Ltd, established in Milton Keynes (United Kingdom),

represented by R. Subiotto QC, and T. Kuhn, lawyer,

applicants,

supported by

European Federation of Pharmaceutical Industries and Associations (EFPIA), established in Geneva (Switzerland), represented by F. Carlin, Barrister, and M. Healy, Solicitor,

intervener,

v

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

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: L. Grzegorczyk, Administrator,

having regard to the written procedure and further to the hearing on 26 November 2015,

gives the following

Judgment

Summary of the facts and background to the dispute

I – The companies involved in the present case

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

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

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

4 The Commission regarded Merck and GUK as constituting a single undertaking for the purpose of competition law at the time of the infringements (‘Merck (GUK)’).

5 Arrow Group A/S, which was renamed Arrow Group ApS in August 2003 (hereinafter referred to without distinction as ‘Arrow Group’), is a company governed by Danish law at the head of a group of companies, present in several Member States, which since 2001 has been active in the development and sales of generic medicinal products.

6 Arrow Generics Ltd is a company incorporated in the United Kingdom, a subsidiary owned at first as to 100% and then, from February 2002, as to 76% by Arrow Group.

7 Resolution Chemicals Ltd is a company incorporated in the United Kingdom specialising in the production of active pharmaceutical ingredients (‘APIs’) for generic medicinal products. Until September 2009 it was controlled by Arrow Group.

8 The Commission regarded Arrow Group, Arrow Generics Ltd and Resolution Chemicals Ltd as constituting a single undertaking (‘Arrow’) at the time of the infringements.

9 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.

10 Alpharma ApS was a company governed by Danish law indirectly controlled as to 100% by Alpharma Inc. It had a number of subsidiaries in the European Economic Area (EEA). Following a number of company restructurings, on 31 March 2008 Alpharma ApS became Axellia Pharmaceuticals ApS, renamed Xellia Pharmaceuticals ApS (‘Xellia’) in 2010.

11 The Commission regarded Alpharma Inc., A.L. Industrier AS and Alpharma ApS as constituting a single undertaking (‘Alpharma’) at the time of the infringements.

12 Ranbaxy Laboratories Ltd is a company governed by Indian law specialising in the development and production of APIs and generic medicinal products.

13 Ranbaxy (UK) Ltd is a company governed by English law and a subsidiary of Ranbaxy Laboratories and is responsible for the sale of the latter’s products in the United Kingdom.

14 The Commission regarded Ranbaxy Laboratories Ltd and Ranbaxy (UK) Ltd as constituting a single undertaking (‘Ranbaxy’) at the time of the infringements.

II – The relevant product and the applicable patents

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

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

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

18 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) (‘Lundbeck’s new patents’).

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

20 Secondly, on 13 March 2000 Lundbeck filed a patent application with the Danish authorities relating to a process for the production of citalopram which envisaged a method of purification of the salts used by means of crystallisation. Similar applications were filed in other EEA countries and also with the WIPO and the EPO. Lundbeck obtained patents protecting the crystallisation process in a number of Member States during the first half of 2002: 30 January 2002 in the case of the United Kingdom (‘the crystallisation patent’). 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 genuine prior examination.

21 Thirdly, 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. Lundbeck obtained a similar patent in Denmark on 29 June 2002.

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

III – The agreements at issue

23 In 2002, Lundbeck entered into six agreements concerning citalopram (‘the agreements at issue’) with four undertakings active in the production and/or sale of generic medicinal products, namely Merck (GUK), Alpharma, Arrow and Ranbaxy (‘the generic undertakings’).

A – The agreements with Merck (GUK)

24 Lundbeck entered into two agreements with Merck (GUK).

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

26 Under that agreement, the parties agreed, in particular, that: — there was a risk that certain actions envisaged by GUK in respect of the marketing, distribution and sale of the ‘Products’ might constitute an infringement of Lundbeck’s intellectual property rights and could give rise to claims on the part of Lundbeck (Article 2.1 of the GUK United Kingdom agreement), the ‘Products’ being defined in Article 1.1 of the GUK United Kingdom agreement as ‘the citalopram products developed by GUK in raw material, bulk product and finished pack form as set out in the Schedule and manufactured in accordance with the specification for Products as supplied by GUK at the date of signature. Attached to Schedule 2’; — in view of the agreement between the parties, Lundbeck would pay GUK the sum of 2 million pounds sterling (GBP), in consideration for the delivery of the ‘Products’, in the quantities set out in the agreement, on 31 January 2002 (Article 2.2 of the GUK United Kingdom agreement); — GUK also undertook, in consideration of a further payment of GBP 1 million, to deliver the ‘Products’, as specified in the schedule, on 2 April 2002 (Article 2.3 of the GUK United Kingdom agreement); — the payments made and the delivery of the ‘Products’ by GUK pursuant to Articles 2.2 and 2.3 of the GUK United Kingdom would constitute full and final settlement of any claim that Lundbeck might have against GUK for infringement of its intellectual property rights in connection with the ‘Products’ delivered by GUK up to that date (Article 2.4 of the UK agreement); — Lundbeck undertook to sell its ‘Finished Products’ to GUK and GUK undertook to purchase those ‘Finished Products’ exclusively from Lundbeck for resale by GUK and its affiliates in the United Kingdom during the term and subject to the conditions of the agreement (Article 3.2 of the GUK United Kingdom agreement), those ‘Finished Products’ being defined in paragraph 1.1 of the agreement as ‘products containing citalopram in finished pack form to be supplied by [Lundbeck] to GUK pursuant to this Agreement’; — Lundbeck undertook to pay GBP 5 million of guaranteed net profits to GUK, on condition that GUK ordered the agreed volume of ‘Finished Products’ during the term of the agreement (or a lesser amount to be calculated pro rata to the volume ordered) (Article 6.2 of the GUK United Kingdom agreement).

27 The first extension of the GUK United Kingdom agreement provided, in particular, for monthly payments of the sum of GBP 400000 per month for the implementation of Article 6.2 of the agreement by GUK and amended the definition of ‘net profits’.

28 The second extension of the GUK United Kingdom agreement provided, in particular, for monthly payments of the sum of GBP 750000 per month for the implementation of Article 6.2 of the agreement by GUK.

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

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

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

B – The agreements with Arrow

32 Lundbeck signed two agreements with Arrow.

33 The first of those agreements, relating to the territory of the United Kingdom, was concluded on 24 January 2002 between, on the one hand, Lundbeck and, on the other, Arrow Generics and Resolution Chemicals (together ‘Arrow UK’) (‘the Arrow UK agreement’).

34 The initial term of the Arrow UK agreement was until 31 December 2002 or, if it had been earlier, until the date on which a definitive decision had been delivered in the action which Lundbeck intended to bring against Arrow UK before the United Kingdom courts concerning Arrow UK’s alleged infringement of its patents (‘the infringement action against Arrow’) (Article 4.1 of the Arrow UK agreement). That agreement was extended, on two occasions, by the signing of addenda. The first extension covered the period from 1 January until 1 March 2003 (Article 3.1 of the first addendum to the Arrow UK agreement), while the second extension provided that the agreement was to end either on 31 January 2004 or seven days after signature of the court decision determining the Lagap litigation (Article 4.1 of the second addendum to the Arrow UK agreement). As that litigation was settled on 13 October 2003, the Arrow UK agreement ended on 20 October 2003. It follows that the overall duration of that agreement was from 24 January 2002 until 20 October 2003 (‘the term of the Arrow UK agreement’).

35 As regards the content of the Arrow United Kingdom agreement, it should be observed that: — the first recital in the preamble to that agreement (‘the Arrow UK preamble’) refers, inter alia, to the fact that Lundbeck is the holder of the crystallisation and film distillation patents; — the fourth recital in the Arrow UK preamble states that ‘… Arrow [UK] has obtained a licence from a third party to import into the [United Kingdom] Citalopram not manufactured by Lundbeck or with the consent of Lundbeck (“the said Citalopram”, which definition shall for the avoidance of doubt comprise only citalopram for marketing and sale in the [United Kingdom] and shall exclude Citalopram for marketing and sale in other countries)’; — the sixth recital in the Arrow UK preamble states that Lundbeck performed a laboratory analysis of ‘the said Citalopram’ which gave it substantial reason to believe that that citalopram infringed, in particular, the patents referred to in the first indent above; — the seventh recital in the Arrow UK preamble states that Arrow UK does not consider that it has infringed those patents or that they are valid, but accepts that Lundbeck believes that they may be valid and have been infringed, which Arrow UK is unable to disprove by incontrovertible evidence; — the eighth recital in the preamble to that agreement observes that Lundbeck has threatened to seek an interim injunction and that it intends to bring infringement proceedings against Arrow; — Article 1.1 of that agreement provides that ‘Arrow [UK] on its own behalf and on behalf of all associated and related entities undertakes during the [term of the Arrow UK agreement] not in the United Kingdom to make, dispose of, offer to dispose of, use or, after the second delivery date, import or keep for disposal or otherwise (1) the said Citalopram or (2) any other Citalopram which Lundbeck alleges to infringe its [intellectual property] Rights and, to enable Lundbeck to ascertain if there may be an infringement, during the [term of the Arrow UK agreement] to provide Lundbeck with sufficient samples for analysis purposes at least one month prior to any threatened manufacture, importation, sale or offer for sale pending a final unappealable decision in [the infringement action against Arrow] …’; — Article 1.2 of that agreement states that Arrow UK has agreed that the undertakings given by it and referred to in Article 1.1 of the Arrow UK agreement may be incorporated in an order that Lundbeck might ask the competent United Kingdom court to make; — Article 2.1 of that agreement states that Lundbeck will commence the infringement action against Arrow as soon as possible and in any event no later than 31 March 2002; — Article 2.2 of that agreement states that, in consideration of the undertakings in Article 1.1 of the Arrow UK agreement and Arrow not seeking a ‘cross-undertaking in damages’ (i.e. the amount which, in accordance with the laws of England and Wales, Lundbeck would have had to deposit with the Court if it intended to seek an injunction in the infringement action against Arrow), Lundbeck is to pay Arrow UK GBP 5 million, in four instalments, that sum having subsequently been increased by GBP 450000 under Article 2.1 of the first addendum to the Arrow UK agreement, and by GBP 1.35 million in application of Articles 2.1 and 3 of the second addendum to the Arrow UK agreement; — Article 2.3 of that agreement establishes that, in the event that the final decision in the infringement action against Arrow should find that Arrow UK had not infringed Lundbeck’s intellectual property rights, the amount specified in Article 2.2 of that agreement would constitute the full and final compensation that Arrow UK could obtain from Lundbeck for loss sustained as a result of the obligations arising under Article 1.1 of the Arrow UK agreement; — Article 3.4 of the agreement provides that Arrow UK is to deliver to Lundbeck its stock ‘of said Citalopram’ in two stages, the first of which, covering approximately 3.975 million packed tablets, by no later than 6 February 2002 and the second, covering around 1.1 million bulk tablets, by no later than 15 February 2002.

36 It should be observed, moreover, that on 6 February 2002 Lundbeck obtained the order referred to in Article 1.2 of the Arrow UK agreement (‘the Arrow consent order’).

37 The second agreement, concerning Denmark, was concluded on 3 June 2002 between Lundbeck and Arrow Group (‘the Arrow Danish agreement’).

38 The Arrow Danish agreement was intended to run from the date of signature, 3 June 2002, until 1 April 2003 or until such earlier date of a definitive decision in the infringement action against Arrow. As no such decision was delivered, the agreement was in force from 3 June 2002 until 1 April 2003 (‘the term of the Arrow Danish agreement’).

39 As regards the content of the Arrow Danish agreement, it should be observed that: — the first, third and fifth to ninth recitals in the preamble thereto correspond, in essence, to the first, fourth and sixth to eighth recitals in the Arrow UK preamble, it being noted that the ninth recital in the Arrow Danish preamble refers to the Arrow consent order; — Article 1.1 of that agreement provides that ‘Arrow [Group] consents to cancel, cease and desist from any importation, manufacture, production, sale or other marketing of products containing Citalopram which Lundbeck alleges to infringe its intellectual property rights in the [Danish] territory for the term of [the Arrow Danish agreement]’; — Article 2.1 of that agreement states that, as compensation for the undertakings given by Arrow Group, Lundbeck is to pay Arrow Group the sum of 500000 United States dollars (USD); — Article 2.2 of that agreement establishes that, in the event that the final decision in the infringement proceedings against Arrow should find that Arrow Group had not infringed Lundbeck’s intellectual property rights, the amount specified in Article 2.1 of that agreement would constitute the full and final compensation that Arrow Group could obtain from Lundbeck for loss sustained as a result of the obligations arising under Article 1.1 of the Arrow Danish agreement; — Article 3.1 of that agreement adds that Lundbeck is to purchase Arrow Group’s stock of citalopram, consisting of approximately 1 million tablets, for the price of USD 147000.

C – The agreement with Alpharma

40 Lundbeck signed an agreement with Alpharma on 22 February 2002 (‘the Alpharma agreement’), to run from that date until 30 June 2003 (‘the term of the Alpharma agreement’).

41 Before concluding that agreement, in January 2002 Alpharma had bought from Alfred E. Tiefenbacher GmbH & Co. (‘Tiefenbacher’) a stock of generic citalopram tablets developed on the basis of the citalopram API produced by the Indian company Cipla according to its own processes (‘the Cipla citalopram’ or ‘the Cipla API’) and had ordered further supplies.

42 As concerns the preamble to the Alpharma agreement, 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 Alpharma has produced or purchased pharmaceutical products containing ‘Citalopram’ in ‘the Territory’, without Lundbeck’s consent; — the fifth and sixth recitals state that Alpharma’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 infringement action against Alpharma’) seeking an injunction ‘against Alpharma’s sale of products containing Citalopram for infringing Lundbeck’s intellectual property rights’; — the eighth recital states that Alpharma acknowledges that Lundbeck’s findings are correct and undertakes to refrain from marketing of ‘such products’; — The ninth and tenth recitals state that Lundbeck: — ‘has agreed to compensate Alpharma 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 Alpharma’s stock of products containing Citalopram and to compensate Alpharma for such products’.

43 As regards the body of the Alpharma agreement, it should be observed, in particular, that: — Article 1.1 stipulates that Alpharma 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 infringement action against Alpharma; — that same article specifies that it is not to apply to escitalopram; — Article 1.2 provides that ‘[i]n the event of any breach of the obligation set forth in Article 1.1 or at the request of Lundbeck, Alpharma … 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 Alpharma the sum of USD 12 million, of which USD 11 million is to be for Alpharma’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, Alpharma 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 Alpharma agreement and the 16 million tablets which it had ordered.

44 Appendix A contains a list of 28 intellectual property rights applications lodged by Lundbeck before the signing of the agreement, 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.

45 Furthermore, it should be noted that on 2 May 2002 a United Kingdom court granted a consent order staying all proceedings in the infringement action against Alpharma because of the conclusion of the agreement between Lundbeck and, among others, Alpharma, according to which Alpharma and its affiliates agreed to ‘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 Alpharma consent order’).

D – The agreement with Ranbaxy

46 Lundbeck signed an agreement with Ranbaxy Laboratories on 16 June 2002 (‘the Ranbaxy agreement’), for a term of 360 days. Under an addendum signed on 19 February 2003 (‘the Ranbaxy addendum’), that agreement was extended until 31 December 2003. The total duration of the agreement is therefore from 16 June 2002 until 31 December 2003 (‘the term of the Ranbaxy agreement’).

47 According to the preamble to the Ranbaxy agreement (‘the Ranbaxy preamble’): — Ranbaxy Laboratories filed two process patent applications in India relating to citalopram and manufactured medicinal products containing citalopram with the intention of marketing such products, in particular in the EEA (second and third recitals in the Ranbaxy preamble and Appendix A to the Ranbaxy agreement); — Lundbeck performed laboratory analyses on that citalopram and concluded that the processes used infringed the amide patent and the iodo patent, the latter not having been granted yet (see paragraph 19 above), whereas Ranbaxy Laboratories disputed the existence of such infringements (fifth to eighth recitals in the preamble); — Lundbeck and Ranbaxy Laboratories arrived at an agreement in order to avoid costly and time-consuming patent litigation, the outcome of which could not be predicted with absolute certainty (ninth recital in the Ranbaxy preamble).

48 According to the Ranbaxy agreement, in particular: — ‘Subject to the terms and conditions of this Agreement and subject to payment of the Settlement Amount by Lundbeck, [Ranbaxy Laboratories] shall not … claim any rights on the Patent Application [referred to in the preamble] or any production method used by [Ranbaxy Laboratories] and shall cancel, cease and desist from any manufacture or sale of pharmaceutical products based hereon [in particular in the EEA] during the term of this Agreement’ (Article 1.1 of the Ranbaxy agreement and Article 1.0 of the Ranbaxy addendum); — ‘In the event of any breach of the obligation set forth in Article 1.1 or at the request of Lundbeck’, Ranbaxy Laboratories and Ranbaxy (UK) would voluntarily submit to an interim injunction by any competent national court, without Lundbeck providing any kind of security or any undertaking other than the undertakings arising under that agreement (Article 1.2 of the Ranbaxy agreement); — in consideration of the agreement arrived at between the parties, Lundbeck was to pay to Ranbaxy Laboratories the sum of USD 9.5 million, in instalments over the relevant period (Article 1.3 of the Ranbaxy agreement and Article 2.0 of the Ranbaxy addendum); — Lundbeck was to sell citalopram tablets to Ranbaxy Laboratories or Ranbaxy (UK), with a discount of 40% on the ex-factory price, so that they could sell those tablets on the United Kingdom market (Article 1.3 of, and Appendix B to, the Ranbaxy agreement); — Lundbeck and Ranbaxy Laboratories undertook not to initiate legal proceedings against each other on the basis of any of the patents referred to earlier in the agreement itself (Article 1.4 of the Ranbaxy agreement).

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

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

50 Since most of those agreements concerned the whole of the EEA or, at 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.

51 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.

52 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.

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

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

55 In 2010 and the first half of 2011, the Commission sent requests for information to Lundbeck and to the other companies which were parties to the agreements at issue.

56 On 24 July 2012, the Commission opened proceedings against the companies which were parties to the agreements at issue and sent them, and Lundbeck, a statement of objections.

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

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

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

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

V – Contested decision

61 By the contested decision, the Commission considered that the agreements at issue constituted restrictions of competition ‘by object’ within the meaning of Article 101(1) TFEU and Article 53(1) of the EEA Agreement (Article 1(1) of the contested decision).

62 The two agreements between Merck (GUK) and Lundbeck were considered to have constituted a single and continuous infringement lasting from 24 January 2002 until 1 November 2003.

63 As is apparent from the summary set out in recitals 824 and 874 of the contested decision, the Commission relied, in particular, on the following factors in that respect: — at the time of concluding those agreements, Lundbeck and Merck (GUK) were at least potential competitors in the United Kingdom and in the EEA and actual competitors in the United Kingdom before the second extension of the GUK United Kingdom agreement; — Lundbeck transferred significant value to Merck (GUK) pursuant to those agreements; — that transfer of value was linked to the acceptance by Merck (GUK) of the limitations on market entry set out in those agreements, notably its commitment not to sell Natco’s citalopram or any other generic citalopram in the United Kingdom and in the EEA during the relevant term of those agreements; — that transferred value corresponded approximately to the profits Merck (GUK) expected to make if it had successfully entered the market; — Lundbeck could not have obtained those limitations on entry through enforcement of its process patents, since the obligations on Merck (GUK) under those agreements went beyond the rights granted to holders of process patents; — those agreements contained no commitment from Lundbeck to refrain from bringing infringement proceedings against Merck (GUK) if the latter entered the market with generic citalopram after the expiry of the agreements.

64 The two agreements between Arrow and Lundbeck were considered to have constituted a single and continuous infringement lasting from 24 January 2002 until 20 October 2003.

65 As is apparent from the summaries in recitals 962 and 1013 of the contested decision, relating to Arrow UK agreement and the Arrow Danish agreement respectively, the Commission relied, in particular, on the following factors: — at the time those agreements were concluded, Lundbeck and Arrow were at least potential competitors in the United Kingdom and in Denmark; — Lundbeck transferred significant value to Arrow pursuant to those agreements; — that transfer of value was linked to Arrow’s acceptance of the limitations on its entry to the citalopram market in the United Kingdom and in Denmark contained in those agreements, in particular Arrow’s commitment not to sell generic citalopram, which Lundbeck regarded as infringing its patents, during the respective terms of those agreements; — that transferred value corresponded approximately to the profit that Arrow expected to make if it had successfully entered the market; — Lundbeck could not have obtained those limitations through enforcement of its new patents, since the obligations on Arrow under those agreements went beyond the rights granted to holders of process patents; — those agreements contained no commitment from Lundbeck to refrain from bringing infringement proceedings against Arrow if the latter entered the United Kingdom or Danish markets with generic citalopram after the expiry of one of those agreements.

66 As regards the Alpharma agreement, as stated in the summary set out in recital 1087 of the contested decision, the Commission relied, in particular, on the following factors: — at the time when they concluded that agreement, Lundbeck and Alpharma were at least potential competitors in a number of EEA countries; — Lundbeck transferred significant value to Alpharma pursuant to that agreement; — that transfer of value was linked to Alpharma’s acceptance of the limitations on entry to the market contained in that agreement, and in particular to Alpharma’s commitment not to sell any generic citalopram in the EEA during the relevant period; — that transferred value corresponded approximately to the profit Alpharma expected to make if it had successfully entered the market; — Lundbeck could not have obtained those limitations through the application of the crystallisation and film distillation patents, since the obligations placed on Alpharma under that agreement went beyond the rights granted to holders of process patents; — the agreement contained no commitment from Lundbeck to refrain from bringing infringement proceedings against Alpharma if the latter entered the market with generic citalopram after the expiry of the agreement.

67 As regards the Ranbaxy agreement, as is apparent from the summary set out in recital 1174 of the contested decision, the Commission relied, in particular, on the following factors: — at the time of concluding that agreement, Lundbeck and Ranbaxy were at least potential competitors in the EEA; — Lundbeck transferred significant value to Ranbaxy pursuant to that agreement; — that transfer of value was linked to Ranbaxy’s acceptance of the limitations on its entry to the market set out in that agreement, and in particular to Ranbaxy’s commitment not to manufacture or sell citalopram in the EEA during the relevant period, whether through its own subsidiaries or via third parties; — that transferred value considerably exceeded the profit that Ranbaxy could have expected to make by selling the generic citalopram it had manufactured until then; — Lundbeck could not have obtained those limitations by enforcing its process patents, since the obligations on Ranbaxy under that agreement went beyond the rights granted to holders of process patents; — that agreement contained no commitment from Lundbeck to refrain from bringing infringement proceedings against Ranbaxy if the latter entered the market with its generic citalopram after the expiry of the agreement.

68 The Commission also imposed fines on all the parties to the agreements at issue. To that end, it applied the Guidelines on the method of setting fines imposed pursuant to Article 23(2)(a) of Regulation No 1/2003 (OJ 2006 C 210, p. 2) (‘the 2006 Guidelines’). In Lundbeck’s case, the Commission followed the general methodology described in the 2006 Guidelines, based on the value of sales of the relevant product made by each participant in an infringement (recitals 1316 to 1358 of the contested decision). In the case of the other parties to those agreements 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).

69 Thus, as regards the parties to the agreements at issue other than Lundbeck, 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).

70 As regards Lundbeck, the Commission applied the general method described in the 2006 Guidelines, taking as a basis the value of sales on the relevant market. Since Lundbeck’s sales of citalopram had significantly decreased during the course of the agreements, and since the agreements did not cover a full business year, the Commission calculated an average annual value of sales. For that purpose, it first calculated the monthly average value of Lundbeck’s sales of citalopram during the term of each of the agreements at issue, then multiplied that value by 12 (recital 1326 and footnote No 2215 of the contested decision).

71 The Commission also imposed four separate fines on Lundbeck, since the six agreements at issue were regarded as giving rise to four separate infringements, in so far as the two agreements between Lundbeck and Merck (GUK) gave rise to a single and continuous infringement, as did the two agreements between Lundbeck and Arrow. In order to avoid arriving at a disproportionate fine, the Commission nevertheless applied a negative weighting in the light of the circumstances of the case, based on a method reflecting the geographic and temporal overlaps between the various infringements (recital 1329 of the contested decision). That method resulted in a reduction of 15% for each infringement where overlaps were found (footnote No 2218 of the contested decision).

72 In the light of the gravity of the infringements found, which the Commission classified as ‘serious’, since they entailed market exclusion; Lundbeck’s high market share of the product to which the infringements related; the wide geographic scope of the agreements at issue; and the fact that all the agreements had been implemented, the Commission considered that the proportion of the value of sales to be applied should be set at 11% for the infringements where the geographic scope was the entire EEA and 10% for the other infringements (recitals 1331 and 1332 of the contested decision).

73 The Commission applied a multiplier to that amount to take account of the duration of the infringements (recitals 1334 to 1337 of the contested decision) and an additional amount of 10% for the first infringement committed, that is to say, the infringement concerning the agreements with Arrow, in application of point 25 of the 2006 Guidelines, in order to ensure that the fines would be sufficiently deterrent (recital 1340 of the contested decision).

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

75 On the basis of those considerations, and taking into account the fact that the GUK United Kingdom agreement had been signed by Lundbeck Ltd, the Commission imposed a total fine of EUR 93766000 on Lundbeck A/S, of which EUR 5306000 jointly and severally with Lundbeck Ltd, composed as follows (recitals 1238 and 1358 and Article 2 of the contested decision): — EUR 19893000 for the agreements concluded with Merck (GUK), of which EUR 5306000 jointly and severally with Lundbeck Ltd; — EUR 12951000 for the agreements concluded with Arrow; — EUR 31968000 for the agreement concluded with Alpharma; and — EUR 28954000 for the agreement concluded with Ranbaxy.

Procedure and forms of order sought

76 By application lodged at the Court Registry on 30 August 2013, the applicants, Lundbeck A/S and Lundbeck Ltd, brought the present action.

77 By order of the President of the Ninth Chamber of 20 May 2014, the European Federation of Pharmaceutical Industries and Associations (‘EFPIA’ or ‘the intervener’) was granted leave to intervene in the present proceedings, in support of the form of order sought by the applicants.

78 In the context of measures of organisation of procedure provided for in Article 64 of the Rules of Procedure of the General Court of 2 May 1991, the main parties were invited to comment in writing, in the context of their observations on EFPIA’s statement in intervention, 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).

79 The main parties submitted their observations within the prescribed period, by pleadings lodged at the Court Registry on 15 January 2015.

80 The written stage of the procedure was closed on the same day.

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

82 The parties answered those questions within the prescribed period, by pleadings received at the Court Registry on 30 October 2015.

83 The parties presented oral argument and replied to the questions put by the Court at the hearing on 26 November 2015.

84 The applicants claim that the Court should: — adopt a measure of inquiry requesting the Commission to produce unredacted versions of its correspondence with the KFST; — annul the contested decision; — in the alternative, annul the fines imposed on the applicants pursuant to that decision; — in the further alternative, substantially reduce those fines; — in any event, order the Commission to pay the costs incurred by the applicants; — take any other measure that the Court may deem appropriate.

85 The Commission contends that the Court should: — dismiss the action as unfounded; — order the applicants to pay the costs, with the exception of those incurred by the intervener; — order the intervener to bear its own costs.

86 The intervener claims that the Court should: — annul the contested decision in so far as it concerns the applicants; — order the Commission to pay the costs incurred by the intervener.

87 As regards the applicants’ head of claim asking the Court to adopt a measure of inquiry requesting the Commission to produce unredacted versions of its correspondence with the KFST, it must be noted that, following the spontaneous communication of those documents in the present proceedings, the applicants confirmed at the hearing that they did not wish to maintain that head of claim.

Law

88 The applicants raise ten pleas in law in support of their action. It is appropriate to examine those pleas in the order in which they have been set out by the applicants.

I – The first plea in law, alleging errors of law and of assessment in that the contested decision considered that the generic undertakings and Lundbeck were at least potential competitors at the time the agreements at issue were concluded

89 The applicants submit that the contested decision misinterprets the relevant case-law on establishing whether an agreement restricts potential competition, which presupposes the existence of real concrete possibilities of entering the market in the absence of the agreement, and they maintain that the Commission disregarded essential facts in that respect.

90 Before examining the applicants’ arguments, it is appropriate to give a brief summary of the relevant case-law and of the approach taken by the Commission in the contested decision as regards the potential competition between Lundbeck and the generic undertakings.

A – Analysis relating to potential competition in the contested decision

91 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.

92 The first phase may begin several years before the expiry of the patent on an API, when generic producers that want to launch a generic version of the medicinal product concerned begin developing viable production processes leading to a product that meets regulatory requirements. Next, in the second phase, in order to prepare for actual market entry, a generic undertaking must apply for marketing authorisations (‘MAs’) pursuant to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, p. 67), order tablets from one or more generic producers or produce them itself and find distributors or set up its own distribution network, that is to say, it must take a series of preliminary steps, without which there would never be any effective competition on the market.

93 The impending expiry of the patent on an API therefore generates a dynamic competitive process, during which the various undertakings producing generic medicinal products compete to be the first to enter the market. The first of those undertakings to enter the market can generate significant profits, before competition intensifies and prices fall drastically. That is why those 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.

94 In those two phases of potential competition, undertakings which produce generic medicinal products or which intend to sell them 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.

95 In recitals 621 to 623 of the contested decision, the Commission noted that, in the present case, Lundbeck’s original patents had expired by January 2002 in most EEA countries. That had generated a dynamic competitive process, in which several undertakings producing or selling generic medicinal products had taken steps in order to be the first to enter the market. Lundbeck had been aware of that threat since December 1999, when it wrote in a strategic plan for 2000 that ‘by 2002 ... generics [were] expected to have captured a substantial share of Cipramil sales’. Likewise, in December 2001, Lundbeck wrote in its strategic plan for 2002 that it expected that the United Kingdom market in particular would be severely hit by generic competition. In the light of those factors, the Commission took the view that the generic undertakings were exerting competitive pressure on Lundbeck at the time the agreements at issue were concluded.

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

97 In recital 635 of the contested decision, the Commission identified eight possible routes to the market in the present case, namely: — first, launching the product ‘at risk’ and facing possible infringement actions brought by Lundbeck; — secondly, making efforts to ‘clear the way’ with the originator undertaking before entering the market, especially in the United Kingdom; — thirdly, requesting a declaration of non-infringement from a national court before entering the market; — fourthly, claiming patent invalidity before the national courts, as a counter-claim to a claim of patent infringement made by the originator undertaking; — fifthly, opposing a patent before the competent national authorities or the EPO and requesting that the patent be revoked or narrowed; — sixthly, working with the current API producer or its supplier — in the case of Merck (GUK), Schweizerhall Pharma International GmbH (‘Schweizerhall’) — to change the API producers’ process in such a way as to eliminate or reduce the risk of infringement of the originator undertaking’s process patents; — seventhly, switching to another API producer within the existing supply contract; — eighthly, switching to another API producer outside of the existing supply contract, either because the existing supply contract permits it or possibly because an exclusive supply contract could be invalidated if the supplied API were found to infringe Lundbeck’s process patents.

B – Applicable principles and case-law

1. The concept of potential competition

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

99 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 98 above, EU:T:2012:332, paragraph 85).

100 In order to determine whether an undertaking is a potential competitor in a market, the Commission is required to determine whether, if the agreement in question had not been concluded, there would have been real concrete possibilities for it to enter that market and to compete with established undertakings. Such a demonstration must not be based on a mere hypothesis, but must be supported by factual evidence or an analysis of the structures of the relevant market. Accordingly, an undertaking cannot be described as a potential competitor if its entry into a market is not an economically viable strategy (see judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 98 above, EU:T:2012:332, paragraph 86 and the case-law cited).

101 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 98 above, EU:T:2012:332, paragraph 87 and the case-law cited).

102 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 currently operating in that market, a pressure represented by the likelihood that a new competitor will enter the market if the market becomes more attractive (judgment in Visa Europe and Visa International Service v Commission, cited in paragraph 99 above, EU:T:2011:181, paragraph 169).

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

104 Although it follows from that case-law that the Commission may rely inter alia on the perception of the undertaking present on the market in order to assess whether other undertakings are potential competitors, nevertheless, the purely theoretical possibility of market entry is not sufficient to establish the existence of potential competition. The Commission must therefore demonstrate, by factual evidence or an analysis of the structures of the relevant market, that the market entry could have taken place sufficiently quickly for the threat of a potential entry to influence the conduct of the participants in the market, on the basis of costs which would have been economically viable (see, to that effect, judgment in E.ON Ruhrgas and E.ON v Commission, cited in paragraph 98 above, EU:T:2012:332, paragraphs 106 and 114).

2. The burden of proof

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

106 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 105 above, EU:T:2013:188, paragraph 92 and the case-law cited).

107 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 105 above, EU:T:2013:188, paragraph 93 and the case-law cited).

108 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 105 above, EU:T:2013:188, paragraph 95 and the case-law cited).

109 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 105 above, EU:T:2013:188, paragraph 96 and the case-law cited).

110 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 105 above, EU:T:2013:188, paragraph 97 and the case-law cited).

111 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).

112 Nevertheless, where the Commission has documentary evidence of an anticompetitive practice, it is not sufficient for the undertakings concerned to prove circumstances which cast the facts established by the Commission in a different light and thus allow another explanation of the facts to be substituted for the one adopted by the Commission. In the presence of documentary evidence, the burden is on those undertakings not merely to submit another explanation for the facts found by the Commission but to challenge the existence of those facts established on the basis of the documents produced by the Commission (see, to that effect, judgment in CISAC v Commission, cited in paragraph 105 above, EU:T:2013:188, paragraphs 99 and 102 and the case-law cited).

3. The extent of the Court’s review

113 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).

114 The applicants’ arguments concerning the absence of potential competition between them and the generic undertakings at the time the agreements were concluded must be examined in the light of those considerations.

C – The first part, alleging that the launch of medicinal products that infringe third parties ’ intellectual property rights is not the expression of potential competition under Article 101 TFEU

115 The applicants submit that the contested decision is vitiated by an error in law in that it takes the view that the launch of medicinal products that infringe third parties’ intellectual property rights is the expression of potential competition under Article 101 TFEU. Basing the existence of potential competition on the hypothesis of the launch of generic medicinal products on the market, with the risk of facing infringement proceedings on the basis of those third parties’ patents, is incompatible with the protection conferred on patents and the exclusive rights to which they give rise. Article 101 TFEU protects only lawful competition, which cannot exist where an exclusive right, like a patent, precludes market entry, in law or in fact.

116 The Commission disputes those arguments.

117 The Court notes 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).

118 However, the case-law in no way excludes the application of Article 101(1) TFEU to settlement agreements that may be concluded in relation to patents. On the contrary, if follows from the case-law that, although the existence of rights recognised under the industrial property legislation of a Member State is not affected by Article 101(1) 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, cited in paragraph 117 above, EU:C:1974:114, paragraphs 39 and 40).

119 Likewise, according to the case-law, although the Commission is not competent to determine the scope of a patent, it may not refrain from all action when the scope of the patent is relevant for the purposes of determining whether there has been an infringement of Articles 101 TFEU and 102 TFEU (judgment of 25 February 1986 in Windsurfing International v Commission, 193/83, ECR, ‘the Windsurfing judgment’, EU:C:1986:75, paragraph 26). The Court of Justice has also held that the specific subject matter of the patent cannot be interpreted as also affording protection against actions brought in order to challenge the patent’s validity, in view of the fact that it is in the public interest to eliminate any obstacle to economic activity which may arise where a patent was granted in error (the Windsurfing judgment, EU:C:1986:75, paragraph 92).

120 In the present case, the applicants’ argument is based on the erroneous premiss that, first, the generic undertakings undoubtedly infringed the applicants’ patents and, secondly, those patents would certainly have withstood the claims of invalidity that would have been raised by the generic undertakings in infringement actions.

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

122 As the Commission rightly points out, without this being called into question by the applicants, in the present case it was for the applicants to prove before the national courts, in the event that generics entered the market, that those generics infringed one of their process patents, since an ‘at risk’ entry is not unlawful in itself. Moreover, in the context of an infringement action brought by Lundbeck against the generic undertakings, those undertakings could have contested the validity of the patent on which Lundbeck relied by raising a counter-claim. Such claims occur frequently in patent litigation and lead, in numerous cases, to a declaration of invalidity of the process patent relied on by the patent holder (see recitals 75 and 76 of the contested decision). Thus, it can be seen from the evidence set out in recitals 157 and 745 of the contested decision that Lundbeck itself estimated the probability that its crystallisation patent would be held invalid at 50 to 60%.

123 In addition, it is clear from the contested decision that, in order to establish the existence of potential competition in the present case, the Commission relied on the case-law established in the judgments in European Night Services and Others v Commission, cited in paragraph 99 above (EU:T:1998:198), and Visa Europe and Visa International Service v Commission, cited in paragraph 99 above (EU:T:2011:181), according to which it must be examined whether, given the structure of the market and the economic and legal context within which it functions, there are real concrete possibilities for the undertakings concerned to compete among themselves or for a new competitor to enter the relevant market and compete with established undertakings (recitals 610 and 611 of the contested decision).

124 In that respect, in view of the factors recalled in paragraph 122 above, it must be found that the Commission did not commit an error in considering that Lundbeck’s process patents did not necessarily constitute insurmountable barriers for the generic undertakings (see, to that effect, judgment in Toshiba v Commission, cited in paragraph 103 above, EU:T:2014:263, paragraph 230), which were willing and ready to enter the citalopram market, and which had already made considerable investments to that end at the time the agreements at issue were concluded.

125 It is indeed possible that, in certain cases, the applicants might have been successful before the competent courts and obtained injunctions or damages against the generic undertakings. However, it can be seen from the evidence in the contested decision as regards each of the generic undertakings that that possibility was not perceived at the time as a sufficiently credible threat to them. Thus Merck (GUK) had taken the view, for example, following the publication of the crystallisation patent, that the Natco citalopram was ‘non-infringing’, that ‘none of the published patent applications ... constitute a problem’ and that, in the light of expert statements, it did ‘not have a patent problem at all’ (recitals 237, 248 and 334 of the contested decision).

126 In addition, it was not at all certain that the applicants would have actually initiated litigation in the event that generics entered the market. The contested decision indeed acknowledges that the applicants had put in place a general strategy consisting in threatening infringement actions or bringing such actions on the basis of their process patents. Nevertheless, any decision to bring an action depended on the applicants’ assessment of the probability that an action would be successful and that a marketed generic product would be held to be infringing. Yet they were aware that ‘generic [manufacturers] could have produced citalopram by using the process described in [the applicants’] original compound patent ... or they could have invested to invent an entirely new process’ (recital 150 of the contested decision). Furthermore, faced with possible counter-claims, Lundbeck knew that the crystallisation patent was ‘not the strongest of all patents’ and that it was considered by some of its rivals to be ‘high school chemistry’ (recital 149 of the contested decision).

127 Lastly, it must be observed that, in the present case, Lundbeck’s original patents had already expired when the agreements at issue were concluded, and that the crystallisation patent had not yet been definitively granted in the United Kingdom, for the purpose of Article 25 of the UK Patents Act 1977, when the GUK United Kingdom agreement and the Arrow UK agreement were concluded. The grant of interim measures in favour of Lundbeck in the United Kingdom against Merck (GUK) and Arrow would therefore have been, if not impossible, at the very least unlikely in the event that those undertakings entered the United Kingdom market before that patent was granted. Consequently, it is unlikely that Lundbeck could have obtained injunctions against all of the generic undertakings, even if it had systematically brought actions against them. Likewise, the iodo patent was not granted until 26 March 2003.

128 It must therefore be found, as the Commission did in recital 635 of the contested decision, that in general the generic undertakings had several routes — constituting real concrete possibilities — to enter the market at the time the agreements at issue were concluded (paragraph 97 above). Those possible routes included, inter alia, launching the generic product ‘at risk’, with the possibility of having to face proceedings brought by Lundbeck.

129 That possibility represents the expression of potential competition, in a situation such as that in the present case where Lundbeck’s original patents, concerning both the citalopram API and the cyanation and alkylation processes, had expired and where there were other processes allowing the production of generic citalopram that had not been found to infringe other Lundbeck patents, which the applicants themselves acknowledged in their reply to the statement of objections. In addition, the steps taken and investments made by the generic undertakings in order to enter the citalopram market before concluding the agreements at issue, as set out by the Commission in the contested decision as regards each of the generic undertakings (see recitals 738 to 743 and 827 to 832 as regards Merck (GUK), recitals 877 to 883 and 965 to 969 as regards Arrow, recitals 1016 to 1018 as regards Alpharma and recitals 1090 to 1102 as regards Ranbaxy) — the existence of which has not been contested by the applicants — show that they were ready to enter the market and to accept the risks involved in such an entry.

130 Lastly, the applicants’ argument that an ‘at risk’ entry of the generic undertakings would have been unlawful, with the result that it cannot be regarded as the lawful exercise of actual or potential competition, must also be rejected.

131 The case-law requires only that it be demonstrated that the generic undertakings had real concrete possibilities and the capacity to enter the market, which is certainly the case when those undertakings had made significant investments in order to enter the market and when they had already obtained MAs or had taken the necessary steps to obtain them within a reasonable period. In that respect, it must be borne in mind that some of them even entered the market, at their own risk, before or after the conclusion of the agreements at issue. Thus, NM Pharma, Merck (GUK)’s distributor in Sweden, had made ‘encouraging’ sales for almost five months on the Swedish market, before the conclusion of the EEA agreement, without being worried by Lundbeck (recital 837 of the contested decision). Merck (GUK) had also been able to sell generic citalopram tablets for a value of GBP 3.3 million in the United Kingdom in August 2003, before obtaining a second, more lucrative, extension of the GUK United Kingdom agreement. To accept the applicants’ argument would amount to accepting that such an effective entry to the market does not constitute the expression of potential competition, simply because the applicants were convinced of the unlawful nature of that entry and they could potentially have tried to prevent it by relying on their process patents in infringement actions. For the reasons set out in paragraphs 120 to 122 above, that line of argument must be rejected.

132 Accordingly, the applicants are not correct in their submission that the Commission disregarded the presumption of validity of their patents and the related intellectual property rights by characterising the ‘at risk’ entry of generic undertakings to the market as the expression of potential competition between Lundbeck and those undertakings in the present case.

133 The first part must therefore be rejected.

D – The second part, alleging that the Commission relied on subjective assessments in concluding that the generic undertakings were actual or potential competitors of Lundbeck

134 The applicants maintain that the contested decision errs in relying on the subjective assessment of the parties to the agreements at issue as to whether a patent is valid and whether a product is infringing or non-infringing in order to determine whether those parties were potential competitors.

135 In the first place, they maintain that the contested decision does not prove to the requisite standard that the generic undertakings’ subjective assessment was that they considered that there was a realistic prospect that a court would find that Lundbeck’s patents were invalid and/or that they were not infringed. Under Article 2 of Regulation No 1/2003, it is for the Commission to prove that a non-infringing market entry was possible during the periods covered by the agreements at issue. Such an assessment is based, moreover, on insufficient information which did not remain constant and could not therefore be used to demonstrate the existence of potential competition between the parties to the agreements at issue.

136 In the second place, they argue that the contested decision is flawed and fails to take account of the objective elements which confirm the difficulty which the generic undertakings encountered in entering the market, such as the scientific evidence supplied by Lundbeck proving the existence of a patent infringement, the confirmation, by both the EPO Appeal Board and the Netherlands Patent Office, of the validity of the crystallisation patent on all relevant aspects, or the fact that Lundbeck had been granted preliminary injunctions or other forms of interim relief in more than 50% of the proceedings which it had initiated in 2002-2003. The contested decision therefore fails to establish to the requisite standard the ability of the generic undertakings to enter the market and does not resolve the question whether Lundbeck’s patents were valid and had been infringed at the time of the conclusion of the agreements at issue, which is an objective question.

137 The Commission disputes those arguments.

138 As a preliminary point, the Court confirms the Commission’s approach, as it can be seen from the contested decision as a whole, which consisted in principally taking into account evidence prior to or contemporaneous with the date on which the agreements at issue were concluded (see, by analogy, judgment of 11 July 2014, Esso and Others v Commission, T‑540/08, ECR, EU:T:2014:630, paragraph 75 and the case-law cited).

139 First, the Commission cannot reconstruct the past by imagining the events that would have occurred and which did not in fact occur as a result of those agreements. Secondly, the parties to those agreements now have every interest in arguing that they had no realistic perspective of entering the market or that they thought that their products infringed one of Lundbeck’s patents. Nevertheless, it is solely on the basis of the information available to them at the time and their perception of the market at that time that they decided to adopt a particular course of conduct and concluded the agreements at issue.

140 Moreover, that approach is consistent with the Windsurfing judgment, cited in paragraph 119 above (EU:C:1986:75, paragraph 26), where the Court of Justice held that the Commission was not competent to determine the scope of a patent, but that it could not refrain from all action when the scope of a patent was relevant for the purpose of determining whether there had been an infringement of Articles 101 TFEU and 102 TFEU.

141 The Commission therefore did not err in relying on objective documents reflecting the perception that the parties to the agreements at issue had of the strength of Lundbeck’s process patents at the time those agreements were concluded (see inter alia recital 669 of the contested decision) in order to evaluate the competitive situation between those parties, 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 challenging 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 agreements at issue.

142 In addition, the applicants wrongly submit that the Commission relied ‘almost exclusively’ on such subjective assessments in order to establish the existence of potential competition between them and the generic undertakings in the contested decision. The Commission in fact carried out a careful examination, as regards each of the generic undertakings concerned, of the real concrete possibilities they had of entering the market, relying on objective evidence such as the investments already made, the steps taken in order to obtain an MA and the supply contracts concluded with, amongst others, their API suppliers. Those various pieces of evidence have also been expressly contested by the applicants, as regards each generic undertaking, and will be examined in the sixth to ninth parts below.

143 Similarly, the applicants cannot succeed in their argument that the Commission did not take sufficient account of the evidence which they supplied, showing that their patents were infringed by the generic undertakings and that the crystallisation patent was valid, which was confirmed, inter alia, by the EPO on all relevant aspects in 2009.

144 First, although other statements contemporaneous with the conclusion of the agreements at issue might suggest that the generic undertakings had doubts concerning the non-infringing nature of their products, or that Lundbeck was convinced of the validity of its patents, those statements are not enough to call into question the conclusion that the generic undertakings were perceived as a potential threat for Lundbeck and were liable, by their very existence, to exert competitive pressure on Lundbeck and on the undertakings operating in the same market (see, to that effect, judgment in Visa Europe and Visa International Service v Commission, cited in paragraph 99 above, EU:T:2011:181, paragraph 169). The strongest evidence in that respect is the very fact that Lundbeck concluded agreements with generic undertakings in order to delay their entry to the market (see, to that effect, judgment in Toshiba v Commission, cited in paragraph 103 above, EU:T:2014:263, paragraph 231).

145 Secondly, the evidence invoked by the applicants which dates from after the conclusion of the agreements at issue cannot be decisive in evaluating the existence of potential competition at the time those agreements were concluded. Even if the EPO had confirmed the crystallisation patent on all relevant aspects in 2009 (see recital 166 of the contested decision), it is nevertheless the case that, at the time the agreements at issue were concluded, the generic undertakings as well as Lundbeck itself doubted the validity of that patent and it was possible that a national court might declare it invalid, as had initially occurred at the EPO (recitals 151 and 166 of the contested decision).

146 Furthermore, as the Commission rightly submits, at the time the agreements at issue were concluded, no interim measure had been obtained by Lundbeck, whether against generic undertakings using the Natco citalopram, such as Merck (GUK), against generic undertakings using the Cipla citalopram or the generic citalopram developed from the API produced by the Indian company Matrix (‘the Matrix citalopram’ or ‘the Matrix API’), such as Arrow and Alpharma, or against generic undertakings using the generic citalopram developed from the citalopram API produced by Ranbaxy (‘the Ranbaxy citalopram’ or ‘the Ranbaxy API’), and no court in the EEA had found an infringement of the crystallisation, amide or iodo patents.

147 The applicants are therefore incorrect in their submission that the Commission relied mainly on subjective assessments in order to find that Lundbeck and the generic undertakings were potential competitors at that time the agreements at issue were concluded.

148 Accordingly, the second part must also be rejected.

E – The third part, alleging that challenging a valid patent does not constitute a real concrete possibility of entering the market

149 The applicants submit that the Commission erred in law in taking the view that challenging a valid patent constitutes a real concrete possibility of entering the market. They deny, in particular, that seeking a declaration of non-infringement, or claiming that a patent is invalid, or opposing a patent before the national patent authorities, or before the EPO, could constitute appropriate routes whereby the generic undertakings could enter the market, notwithstanding Lundbeck’s processing patents.

150 In the first place, they maintain that the contested decision confuses market entry with the investments that allow market entry, and that it unduly stretches the boundaries of potential competition. The case-law requires that real concrete possibilities of entering the market be established and that market entry be sufficiently rapid for the threat of potential entry to constitute a constraint on the conduct of market participants. Establishing that there were real concrete possibilities of making investments that, if successful, could allow market entry fails to satisfy that test.

151 In the second place, the presumption of validity enjoyed by patents means that the possibility of challenging the validity of that patent cannot be regarded as constituting a real concrete possibility of entering the market. The approach taken by the Commission in that regard contradicts the judgment of 15 September 1998 in European Night Services and Others v Commission, cited in paragraph 99 above (EU:T:1998:198, paragraph 139).

152 In the third place, even if patent challenges could have constituted a real concrete possibility of entering the market, those challenges would not have made it possible to enter the market sufficiently quickly. As the Commission stated in its pharmaceutical sector inquiry, challenging a patent takes on average almost three years and would therefore not have enabled the generic undertakings to enter the market sufficient quickly. The contested decision is vague on that point, whereas, if the generic undertakings could not have lawfully entered the market during the term of the agreements at issue, the agreements could not have had any impact on competition.

153 In the fourth place, the applicants maintain that, even if the Commission’s view is accepted, the contested decision should at least have demonstrated that, in the absence of the agreements at issue, the generic undertakings would have initiated legal actions and would probably have been successful before the national courts or at least that they had prospects of being successful if they challenged the patents.

154 Lastly, the applicants submit that the Commission’s position is based on an unjustified bias against process patents as opposed to compound patents.

155 The intervener also argues that, in the contested decision, the Commission errs in taking the view that Lundbeck and the generic undertakings were potential competitors. Such a finding fails to take sufficient account of the presumption that Lundbeck’s patents were valid or of the fact that interim injunctions would have represented an insurmountable barrier for the generic undertakings if they had attempted to enter the market. The intervener also rejects the argument that challenging the validity of patents is an inherent part of the competitive process.

156 The Commission disputes those arguments.

157 It must be noted that, contrary to the applicants’ arguments, the Commission did not take the view, in the contested decision, that the mere possibility of challenging the validity of a patent before a court or before the competent authorities suffices to establish the existence of potential competition. In order to establish the existence of potential competition between the generic undertakings and Lundbeck in the present case, the Commission took several factors into consideration, such as the significant investments and efforts already made by the generic undertakings in order to prepare their entry to the market, the fact that they had already obtained MAs or had taken the necessary steps to obtain one within a reasonable period, the fact that the applicants had acknowledged that there were a certain number of processes available to produce citalopram without infringing their patents, the fact that, at the time the agreements at issue were concluded, no court had found the generic products to be infringing and the fact that there was a non-negligible possibility that some of Lundbeck’s process patents might be declared invalid. In addition, a generic undertaking, namely Merck (GUK), even succeeded in entering the market before and during the term of the agreements at issue. Lastly, the fact that the applicants decided to pay significant amounts to the generic undertakings in order to keep them out of the market during the period of the agreements at issue also shows that those generic undertakings were potential competitors, since they were perceived by the applicants as a threat exerting competitive pressure on their position on the market (paragraphs 103 and 144 above).

158 None of the arguments put forward by the applicants is capable of undermining that conclusion.

159 As regards, first, the investments made by the generic undertakings in order to prepare their entry to the market, it suffices to note that the Commission never considered that such investments sufficed by themselves to demonstrate the existence of potential competition between those undertakings and the applicants. The Commission, on the contrary, relied on a set of relevant factors, relating to each generic undertaking, in that respect (see paragraph 157 above). Moreover, as the Commission rightly submitted, in order to establish the existence of potential competition, it is not necessary to demonstrate with certainty that the generic undertakings would have entered the market and that that entry would inevitably have been successful, but only that they had real concrete possibilities in that respect. To assert the contrary would amount to denying any distinction between actual and potential competition.

160 The case-law indeed indicates that the purely theoretical possibility of market entry is not sufficient to establish the existence of potential competition and that the Commission must demonstrate, by factual evidence or an analysis of the structures of the relevant market, that the market entry could have taken place sufficiently quickly for the threat of a potential entry to influence the conduct of the participants in the market, on the basis of costs which would have been economically viable (paragraph 104 above).

161 It does not appear, however, that the Commission disregarded that case-law in the present case, since the analysis of the pharmaceutical sector carried out by the Commission in the contested decision, as well as the particular situation of each generic undertaking at the time the agreements at issue were concluded (paragraph 129 above), adequately demonstrate that the entry of those generic undertakings to the citalopram market was not a mere theoretical possibility, but that they had real concrete possibilities in that respect, as can be seen from the examination of the sixth and ninth parts of the first plea in law below. Moreover, it would be surprising if an undertaking as experienced as Lundbeck would have decided to pay several million euros to the generic undertakings in exchange for their commitment not to enter the market during a certain period if the possibility that those generic undertakings could enter the market was purely theoretical.

162 Secondly, the judgment in European Night Services and Others v Commission, cited in paragraph 99 above (EU:T:1998:198, paragraph 139), relied on by the applicants, does not oppose the approach taken by the Commission in the present case. Although, in that judgment, the Court referred to the existence of exclusive rights precluding, de jure or de facto, in most Member States, both the provision of international passenger services and access to the infrastructure, before the adoption of Council Directive 91/440/EEC of 29 July 1991 on the development of the Community’s railways (OJ 1991 L 237, p. 25), that situation cannot be transposed to the present case, since Lundbeck’s process patents are in no way comparable to the exclusive rights enjoyed by railway undertakings before the adoption of that directive and there are significant differences between the markets concerned. In addition, as the Commission rightly submits, in the case that gave rise to that judgment, the Court had criticised the Commission for failing to carry out a detailed analysis of the market in order to establish the existence of potential competition and for having relied on hypothesises unsupported by any evidence or any analysis of the structures of the relevant market. In the present case, however, the applicants cannot legitimately argue that all of the relevant circumstances, summarised in paragraph 157 above and set out in detail in the contested decision, for each generic undertaking, are purely theoretical speculations unsupported by a detailed analysis of the characteristics of the relevant market.

163 Thirdly, it must be recalled that, in order to establish the existence of potential competition, the case-law requires only that the entry to the market take place within a reasonable period, without fixing a specific limit in that respect. The Commission therefore does not need to demonstrate with certainty that the entry of the generic undertakings to the market would have taken place before the expiry of the agreements at issue in order to be able to establish the existence of potential competition in the present case, particularly since, as the Court of Justice has already held, potential competition may be exerted long before the expiry of a patent (see, to that effect, judgment of 6 December 2012 in AstraZeneca v Commission, C‑457/10 P, ECR, EU:C:2012:770, paragraph 108).

164 In that respect, it should be noted that the remark of the Court of Justice concerning the fact that potential competition may be exerted before the expiry of a patent is independent of the fact that the SPCs at issue in that judgment had been obtained fraudulently or irregularly. The case that gave rise to the judgment in AstraZeneca v Commission, cited in paragraph 163 above (EU:C:2012:770, paragraph 108) concerned, inter alia, an abuse of a dominant position committed by an undertaking which had submitted misleading representations in order to obtain, from the competent national authorities, SPCs allowing it to prevent the 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 regular patents. According to the Court of Justice, not only did such unlawful SPCs lead to a significant exclusionary effect after the expiry of the basic patents, but they were also liable to alter the structure of the market by adversely affecting potential competition even before that expiry. Accordingly, that case-law confirms that potential competition already exists before the expiry of patents protecting a medicinal product and that the steps taken before that expiry are relevant in assessing whether that competition was restricted.

165 Fourthly, the applicants wrongly argue that the Commission should have demonstrated that the generic undertakings would have brought legal proceedings and that they would have been successful before the competent national courts. It can be seen from recital 624 et seq. of the contested decision that the generic undertakings were not required to demonstrate that their generic products did not infringe any patent in order to obtain an MA and sell their products in the market, which, moreover, is not called into question by the applicants. Thus, Merck (GUK) was able to enter the market through its distributor NM Pharma in Sweden in May 2002, without having obtained a declaration of non-infringement and without having had legal actions brought against it by Lundbeck. It was for the originator undertaking, namely, in the present case, Lundbeck, to prove that those products infringed one of its patents, which, according to its own estimates, was particularly difficult to establish, as regards process patents (see recital 629 of the contested decision). In addition, as the Commission submits, it is not certain that Lundbeck would have necessarily brought legal proceedings against the generic undertakings if they had entered the market (see paragraph 126 above). It is even less certain that Lundbeck would have been successful, if it had decided to bring such proceedings (see paragraph 122 above and recitals 75 and 76 of the contested decision).

166 Lastly, it must be recalled that the Commission did not disregard the presumption of validity enjoyed by Lundbeck’s process patents (paragraphs 121 to 132 above). The applicants therefore cannot argue that the contested decision is based on a negative bias against such patents. The Commission took account of the existence of those patents but considered, without committing an error of assessment in that respect, that those patents were not capable of blocking any entry of generic undertakings to the market at the time the agreements at issue were concluded.

167 The third part must therefore be rejected.

F – The fourth part, alleging that the lack of an MA prevents the existence of actual or potential competition

168 The applicants submit that the Commission wrongly concluded that there was potent