8The background to the dispute was set out in paragraphs 1 to 38 of the judgment under appeal as follows:‘The companies involved in the present case1 H. Lundbeck A/S (“Lundbeck”) is a company governed by Danish law which controls a group of companies specialising in the research, development, manufacture, marketing, sale and distribution of pharmaceuticals for the treatment of disorders in the central nervous system, including depression.2 Lundbeck is an “originator” undertaking, namely an undertaking whose activities are focused on researching new medicinal products and bringing them to the market.3 Alpharma Inc. was a company incorporated in the United States of America active in the pharmaceutical sector on a worldwide scale, in particular in generic medicinal products. Until December 2008 it was controlled by A.L. Industrier AS[,] a company governed by Norwegian law. It was subsequently bought by a United Kingdom pharmaceutical undertaking, which, in turn, was bought by a United States pharmaceutical undertaking. In the context of those restructurings, Alpharma Inc. became, first of all, in April 2010, Alpharma LLC, and then, on 15 April 2013, Zoetis Products LLC (“Zoetis”) and, finally, on 6 July 2015, it returned to being Alpharma LLC.4 Alpharma Inc. controlled all the shares in Alpharma ApS, a company governed by Danish law, which had a number of subsidiaries in the European Economic Area (EEA) (hereinafter referred to, overall, as the “Alpharma group”). Following a number of company restructurings, on 31 March 2008 Alpharma ApS became Axellia Pharmaceuticals ApS, renamed Xellia Pharmaceuticals ApS … in 2010.The relevant product and the applicable patents5 The relevant product for the purposes of the present case is the antidepressant medicinal product containing the active pharmaceutical ingredient (“API”) known as citalopram.6 In 1977, Lundbeck filed a patent application in Denmark for the citalopram API and two processes – an alkylation process and a cyanation process – to produce that API. Patents for that API and those processes … were issued in Denmark and in a number of western European countries between 1977 and 1985.7 As regards the EEA, the protection afforded by [those 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, [those patents] expired in January 2002.8 Over time, Lundbeck developed other, more effective, processes for the production of citalopram, in respect of which it applied for and often obtained patents in several EEA countries and also from the World Intellectual Property Organisation (WIPO) and the European Patent Office (EPO).9 First, on 13 March 2000 Lundbeck filed a patent application with the Danish authorities relating to a process for the production of citalopram which envisaged a method of purification of the salts used by means of crystallisation. Similar applications were filed in other EEA countries and also with the WIPO and the EPO. Lundbeck obtained patents protecting the crystallisation process (“the crystallisation patents”) in a number of Member States during the first half of 2002, in particular on 30 January 2002 in the case of the United Kingdom and on 11 February 2002 in the case of Denmark. The EPO granted a crystallisation patent on 4 September 2002. In addition, in the Netherlands, Lundbeck had already obtained, on 6 November 2000, a utility model for that process … that is to say, a patent valid for six years, granted without a prior examination.10 Secondly, on 12 March 2001, Lundbeck filed a patent application with the [authorities of the United Kingdom of Great Britain and Northern Ireland] for a citalopram production process using a salt purification method by film distillation. The United Kingdom authorities granted Lundbeck a patent for that film distillation method on 3 October 2001 (“the film distillation patent”). However, that patent was revoked on 23 June 2004 for lack of novelty by comparison with another Lundbeck patent.11 Lastly, Lundbeck planned to launch a new antidepressant medicinal product, Cipralex, based on the API known as escitalopram (or S-citalopram), by the middle of 2002 or the beginning of 2003. That new medicinal product was designed for the same patients as those who could be treated by Lundbeck’s patented medicinal product Cipramil, based on the citalopram API. The escitalopram API was protected by patents valid until at least 2012.Agreement entered into by Lundbeck with the Alpharma group and other matters relating to the background12 During 2002, Lundbeck entered into six agreements concerning citalopram (“the agreements in question”) with undertakings active in the production and/or sale of generic medicinal products ([“the manufacturers of generic medicines”]), including the Alpharma group.13 The relevant agreement for the purposes of the present case (“the agreement at issue”) was concluded between Lundbeck and Alpharma ApS on 22 February 2002 and covered the period running from that date until 30 June 2003 (“the relevant period”).14 Before concluding that agreement, in January 2002 the Alpharma group had bought from Alfred E. Tiefenbacher GmbH & Co. (“Tiefenbacher”) a stock of generic citalopram tablets produced on the basis of the API of the Indian company Cipla and had ordered further supplies.15 As regards the preamble to the agreement at issue (“the preamble”), it should be observed, in particular, that:– the first recital states that “Lundbeck owns intellectual property rights including, in particular, patent rights relating to the manufacture of the [API] ‘Citalopram’ [(written with an upper case ‘C’ throughout the agreement)], including the patents set out in Appendix A” to that agreement …;– the second recital states that Lundbeck produces and sells pharmaceutical products containing “Citalopram” in all Member States and also in Norway and Switzerland, those countries being together defined as “the Territory”;– the third and fourth recitals mention that the Alpharma group has produced or purchased pharmaceutical products containing “Citalopram” in “the Territory”, without Lundbeck’s consent;– the fifth and sixth recitals state that the Alpharma group’s products have been subjected to laboratory analyses by Lundbeck, the results of which gave Lundbeck substantial reason to believe that the production methods used to produce those products infringed its intellectual property rights;– the seventh recital recalls that, on 31 January 2002, Lundbeck filed a lawsuit with a United Kingdom court (“the UK infringement action”) seeking an injunction “against [the] Alpharma [group’s] sale of products containing Citalopram for infringing Lundbeck’s intellectual property rights”;– the eighth recital states that the Alpharma group acknowledges that Lundbeck’s findings are correct and undertakes to refrain from marketing “such products”;– the ninth and tenth recitals state that Lundbeck:– “has agreed to compensate [the] Alpharma [group] in order for Lundbeck to avoid … patent litigation”, the outcome of which cannot be predicted with absolute certainty and which would be costly and time-consuming;– “in order to settle the dispute, [has] agreed to purchase all of [the] Alpharma [group’s] stock of products containing Citalopram and to compensate [it] for such products”.16 As regards the body of the agreement at issue, it should be observed, in particular, that:– Article 1.1 [of the agreement at issue] stipulates that the Alpharma group and its “Affiliates” “shall cancel, cease and desist from any importation, … production, … or sale of pharmaceutical products containing Citalopram in the Territory … during [the relevant period]” and that Lundbeck is to withdraw the UK infringement action;– Article 1.1 also specifies that it is not to apply to “any product containing escitalopram”;– Article 1.2 provides that “in the event of any breach of the obligation set forth in Article 1.1 [of the agreement at issue] or at the request of Lundbeck, [the] Alpharma [group] … will voluntarily submit to an interim injunction by any competent court in any applicable country in the Territory” and that Lundbeck is to be entitled to obtain such injunction without providing any kind of security;– Article 1.3 states that, as compensation for the obligations set out in that agreement and in order to avoid the costs and time of litigation, Lundbeck is to pay to the Alpharma group the sum of [12 million United States dollars (USD)], of which USD 11 million is to be for the Alpharma group’s products containing “Citalopram”, in three instalments of USD 4 million, to be paid on 31 March 2002, 31 December 2002 and 30 June 2003 respectively;– Article 2.2 establishes that, no later than 31 March 2002, the Alpharma group is to deliver to Lundbeck its entire current stock of products containing “Citalopram”, namely the 9.4 million tablets already in its possession at the time of conclusion of the agreement at issue and the 16 million tablets which it had ordered.17 Appendix A [to the agreement at issue] contains a list of 28 intellectual property rights applications lodged by Lundbeck before the signature of [that 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 [patents] and [the] film distillation [patent].18 Furthermore, it should be noted that on 2 May 2002 a United Kingdom court granted a consent order staying all proceedings in the UK infringement action because of the conclusion of an agreement between Lundbeck and, among others, the Alpharma group, under which the latter would “cancel, cease and desist from all importation … production … or sale, in [the Member States], Norway and Switzerland (‘the Relevant Territories’) of pharmaceutical products containing citalopram manufactured using processes claimed in [the crystallisation patents and the film distillation patent granted by the United Kingdom authorities] or any equivalent patent granted or applied for in relation to the Relevant Territories … until 30 June 2003” …Steps taken by the Commission in the pharmaceutical sector and administrative procedure19 In October 2003, the Commission … was informed of the agreements in question by the Konkurrence- og Forbrugerstyrelsen (the Danish authority for [the protection of] competition and consumers, [“the Danish Competition Authority”]).20 Since most of those agreements concerned the whole of the EEA or, in any event, Member States other than the Kingdom of Denmark, it was agreed that the Commission would examine their compatibility with competition law, while [the Danish Competition Authority] would not pursue the matter.21 Between 2003 and 2006, the Commission carried out inspections within the meaning of Article 20(4) of [Regulation No 1/2003] at the premises of Lundbeck and other companies active in the pharmaceutical sector. It also sent Lundbeck and another company requests for information within the meaning of Article 18(2) of that regulation.22 On 15 January 2008, the Commission adopted the decision initiating an inquiry into the pharmaceutical sector, pursuant to Article 17 of Regulation No 1/2003 (Case No COMP/D2/39514). The single article of that decision stated that the inquiry would relate to the introduction of innovative and generic medicinal products for human consumption on to the market.23 On 8 July 2009, the Commission adopted a communication summarising its report of the inquiry into the pharmaceutical sector. That communication included, as a “technical annex”, the full version of the inquiry report, in the form of a Commission working document, available only in English.24 On 7 January 2010, the Commission opened proceedings against Lundbeck.25 In 2010 and the first half of 2011, the Commission sent requests for information to Lundbeck and, among others, to the other companies which were parties to the agreements in question, including the Alpharma group.26 On 24 July 2012, the Commission opened proceedings against the [manufacturers of generic medicines] which were parties to the agreements in question and sent them, and also Lundbeck, a statement of objections.…30 On 19 June 2013, the Commission adopted [the decision at issue].The [decision at issue]31 By the [decision at issue], the Commission considered that the agreement at issue, and likewise the other agreements in question, constituted a restriction of competition by object within the meaning of Article 101(1) TFEU and Article 53(1) of the [Agreement on the European Economic Area of 2 May 1992 (OJ 1994 L 1, p. 3)], committed by Lundbeck and also by Alpharma ApS, Alpharma Inc. and A.L. Industrier (Article 1(3) of the [decision at issue]).32 As is apparent from the summary set out in recital 1087 of the [decision at issue], the Commission relied, in particular … on the following factors:– at the time when they concluded the agreement at issue, Lundbeck and the Alpharma group were at least potential competitors in a number of EEA countries;– under that agreement, Lundbeck transferred significant value to the Alpharma group;– that transfer of value was linked to the Alpharma group’s acceptance of the limitations on market entry contained in that agreement, and in particular to the Alpharma group’s commitment not to sell any generic citalopram in the EEA during the relevant period;– that transferred value corresponded approximately to the profit that the Alpharma group could have made if it had successfully entered the market;– Lundbeck would not have been able to obtain those limitations through enforcement of the crystallisation [patents] and [the] film distillation [patent] (“Lundbeck’s new [process] patents”), since the obligations placed on the Alpharma group under the agreement at issue went beyond the rights granted to holders of process patents;– the agreement at issue contained no commitment from Lundbeck to refrain from bringing infringement proceedings against the Alpharma group if the latter entered the market with generic citalopram after the expiry of the agreement at issue.33 The Commission also imposed fines on all the parties to the agreements in question. To that end, it applied [the 2006 Guidelines]. Although, in the case of Lundbeck, the Commission followed the general methodology described in the 2006 Guidelines, based on the value of sales of the product achieved by that undertaking (recitals 1316 to 1358 of the [decision at issue]), in the case of the other parties to the agreements in question, however, namely the [manufacturers of generic medicines], 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 [decision at issue]).34 Thus, as regards the parties to the agreements in question other than Lundbeck, including the Alpharma group, the Commission considered that, in order to determine the basic amount of the fine and to ensure that the fine would have a sufficient deterrent effect, it was appropriate to take account of the value of the sums transferred to them by Lundbeck pursuant to those agreements, without differentiating between the infringements on the basis of their nature or geographic scope, or on the basis of the market share of the undertakings concerned, those factors being addressed only for the sake of completeness (recital 1361 of the [decision at issue]).35 As regards the Alpharma group, the Commission considered that the sums which Lundbeck had paid to it amounted to USD 11.1 million, equivalent to EUR 11.7 million, according to the average exchange rate in 2002. That amount consisted of (i) USD 10.1 million for the purchase of the Alpharma group’s stock of citalopram, allowing for a reduction of USD 900000 applied to the instalment paid by Lundbeck on 31 December 2002 (see the fourth indent of paragraph 16 [of the judgment under appeal]) on the ground that the number of tablets received had been lower than the agreed level, and (ii) USD 1 million in respect of the litigation costs saved as a result of the conclusion of the agreement at issue (recitals 545, 547, 1071 and 1374 and footnote [1867] of the [decision at issue]).36 In view of the total length of the investigation, the Commission reduced by 10% the amount of the fines imposed on all the addressees of the [decision at issue] (recitals 1349 and 1380 of the [decision at issue]).37 Last, the Commission applied the second subparagraph of Article 23(2) of Regulation No 1/2003 (which provides that, for each undertaking participating in an infringement, the fine is not to exceed 10% of its total turnover in the preceding business year) separately to [Xellia Pharmaceuticals], Zoetis and A.L. Industrier, since those companies no longer belonged to the same undertaking at the time of adoption of the [decision at issue] (recital 1384 of the [decision at issue]). In the case of A.L. Industrier, the Commission took into account the turnover achieved in 2011, and not that achieved in 2012, since it considered that the figures for 2012 did not relate to a year of normal economic activity (recitals 1386 and 1387 of the [decision at issue]).38 On the basis of those considerations, the Commission imposed a fine of EUR 10530000 jointly and severally on [Xellia Pharmaceuticals] and Zoetis, while the joint and several liability of A.L. Industrier was limited to an amount of EUR 43216 (recital 1396 and Article 2(3) of the [decision at issue]).’
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