25 March 2021 (*1)

[Text rectified by order of 3 September 2021]

(Appeal – Competition – Agreements, decisions and concerted practices – Pharmaceutical products – Market for antidepressants (citalopram) – Settlement agreements relating to disputes concerning process patents concluded by a manufacturer of originator medicines who is the holder of those patents and manufacturers of generic medicines – Article 101 TFEU – Potential competition – Restriction by object – Characterisation – Calculation of the amount of the fine – Rights of the defence – Reasonable time – Loss of documents due to the passage of time – General duty of care – Regulation (EC) No 1/2003 – Second subparagraph of Article 23(2) – Maximum amount of the fine – Taking into account the business year preceding that in which the European Commission’s decision was adopted – Last full year of normal economic activity)

In Case C‑611/16 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 25 November 2016,

Xellia Pharmaceuticals ApS, established in Copenhagen (Denmark),

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

represented by D.W. Hull, solicitor,

appellants,

the other parties to the proceedings being:

[As rectified by order of 3 September 2021] European Commission, represented by F. Castilla Contreras, T. Vecchi, B. Mongin and C. Vollrath, acting as Agents, and B. Rayment, Barrister,

defendant at first instance,

supported by:

United Kingdom of Great Britain and Northern Ireland, represented initially by D. Guðmundsdóttir, Z. Lavery and D. Robertson, acting as Agents, and J. Holmes QC, and subsequently by D. Guðmundsdóttir, acting as Agent, and J. Holmes QC,

intervener in the appeal,

THE COURT (Fourth Chamber),

composed of M. Vilaras, President of the Chamber, D. Šváby (Rapporteur), S. Rodin, K. Jürimäe and P.G. Xuereb, Judges,

Advocate General: J. Kokott,

Registrars: M. Aleksejev, Head of Unit, and C. Strömholm, Administrator,

having regard to the written procedure and further to the hearing on 24 January 2019,

having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,

gives the following

By their appeal, Xellia Pharmaceuticals ApS and Alpharma LLC ask the Court of Justice to set aside the judgment of the General Court of the European Union of 8 September 2016, Xellia Pharmaceuticals and Alpharma v Commission (T‑471/13, not published, EU:T:2016:460; ‘the judgment under appeal’), by which the General Court dismissed their action seeking, first, 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) (‘the decision at issue’) and, second, reduction of the amount of the fine imposed on them by that decision.

Legal context

Regulation (EC) No 1/2003,

Under the heading ‘Investigations into sectors of the economy and into types of agreements’, the first subparagraph of Article 17(1) of Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles [101 and 102 TFEU] (OJ 2003 L 1, p. 1) provides:

‘Where the trend of trade between Member States, the rigidity of prices or other circumstances suggest that competition may be restricted or distorted within the [internal market], the Commission may conduct its inquiry into a particular sector of the economy or into a particular type of agreements across various sectors. In the course of that inquiry, the Commission may request the undertakings or associations of undertakings concerned to supply the information necessary for giving effect to Articles [101and 102 TFEU] and may carry out any inspections necessary for that purpose.’

Article 21(3) of that regulation provides:

‘A decision adopted pursuant to paragraph 1 cannot be executed without prior authorisation from the national judicial authority of the Member State concerned. The national judicial authority shall control that the Commission decision is authentic and that the coercive measures envisaged are neither arbitrary nor excessive having regard in particular to the seriousness of the suspected infringement, to the importance of the evidence sought, to the involvement of the undertaking concerned and to the reasonable likelihood that business books and records relating to the subject matter of the inspection are kept in the premises for which the authorisation is requested. The national judicial authority may ask the Commission, directly or through the Member State competition authority, for detailed explanations on those elements which are necessary to allow its control of the proportionality of the coercive measures envisaged. However, the national judicial authority may not call into question the necessity for the inspection nor demand that it be provided with information in the Commission’s file. The lawfulness of the Commission decision shall be subject to review only by the Court of Justice.’

4.4

Article 23(2) of that regulation provides:

‘The Commission may by decision impose fines on undertakings and associations of undertakings where, either intentionally or negligently:

(a) they infringe Article [101 or 102 TFEU]; or

…

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

…’

The 2006 Guidelines on the method of setting fines

Points 19 to 22 and 37 of 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’), state as follows:

‘19. The basic amount of the fine will be related to a proportion of the value of sales, depending on the degree of gravity of the infringement, multiplied by the number of years of infringement.

22. In order to decide whether the proportion of the value of sales to be considered in a given case should be at the lower end or at the higher end of that scale, the Commission will have regard to a number of factors, such as the nature of the infringement, the combined market share of all the undertakings concerned, the geographic scope of the infringement and whether or not the infringement has been implemented.

…

37. Although these Guidelines present the general methodology for the setting of fines, the particularities of a given case or the need to achieve deterrence in a particular case may justify departing from such methodology or from the limits specified in point 21.’

The decision of 15 January 2008 initiating an inquiry into the pharmaceutical sector

Recitals 3 to 5 and recital 8 of the Commission decision of 15 January 2008 initiating an inquiry into the pharmaceutical sector, pursuant to Article 17 of Regulation (EC) No 1/2003 (Case No COMP/D2/39.514) (‘the decision of 15 January 2008 initiating an inquiry into the pharmaceutical sector’) are worded as follows:

‘(3) Certain circumstances relating to competition by innovative and generic medicines in general suggest that competition may be restricted or distorted in the pharmaceutical sector in Europe, such as a decline in innovation as measured by the number of novel medicines reaching the market and instances of lacking timely entry by suppliers of generic medicines.

(4) There are indications of commercial practices by pharmaceutical suppliers including notably patenting or the exercise of patents which may not serve to protect innovation but to block innovative and/or generic competition, litigation, which may be vexatious, and agreements, which may be collusive.

(5) These practices may cause market distortion when they unduly fence off incumbent suppliers of drugs from innovative or generic competition, for example, due to de facto extended patent protection through unilateral conduct or agreements. Such practices may limit consumer choice, reduce economic incentives to invest in research and development of new products and damage public and private health budgets.

…

(8) To the extent that the inquiry into the pharmaceutical sector reveals the possible existence of anticompetitive agreements or practices or abuses of a dominant position, the Commission or, where appropriate, the national competition authorities could envisage taking the appropriate measures to restore competition in the sector, including opening investigations against individual entities possibly resulting in decisions based on Article [101] and/or Article [102 TFEU].’

Background to the dispute

7.7

The present appeal is one of six related appeals brought against six judgments of the General Court that were delivered following actions for annulment brought against the decision at issue, namely, in addition to the present appeal: the appeal lodged in Case C‑586/16 P (Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission) against the judgment of 8 September 2016, Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission (T‑460/13, not published, EU:T:2016:453); the appeal lodged in Case C‑588/16 P (Generics (UK) v Commission) against the judgment of 8 September 2016, Generics (UK) v Commission (T‑469/13, not published, EU:T:2016:454); the appeal lodged in Case C‑591/16 P (Lundbeck v Commission) against the judgment of 8 September 2016, Lundbeck v Commission (T‑472/13, EU:T:2016:449); the appeal lodged in Case C‑601/16 P (Arrow Group and Arrow Generics v Commission) against the judgment of 8 September 2016, Arrow Group and Arrow Generics v Commission (T‑467/13, not published, EU:T:2016:450); and the appeal lodged in Case C‑614/16 P (Merck v Commission) against the judgment of 8 September 2016, Merck v Commission (T‑470/13, not published, EU:T:2016:452).

8.8

The 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 case

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

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

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

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

The relevant product and the applicable patents

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

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

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.

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.

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).

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.

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.

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

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

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.

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”).

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.

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”.

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

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].

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 procedure

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”]).

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.

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.

On 15 January 2008, the Commission adopted the decision initiating an inquiry into the pharmaceutical sector, pursuant to Article 17 of Regulation (EC) 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.

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.

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

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.

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.

…

On 19 June 2013, the Commission adopted [the decision at issue].

The [decision at issue]

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]).

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 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;

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;

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.

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.

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]).

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]).

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]).

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]).

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]).

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]).

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]).

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]).

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]).

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]).

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]).’

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]).

The procedure before the General Court and the judgment under appeal

The procedure before the General Court and the judgment under appeal

By document lodged at the Registry of the General Court on 28 August 2013, Xellia Pharmaceuticals (‘Xellia’) and Zoetis, now Alpharma LCC, brought an action for annulment in part of the decision at issue and reduction of the fine imposed on them by the Commission.

By document lodged at the Registry of the General Court on 28 August 2013, Xellia Pharmaceuticals (‘Xellia’) and Zoetis, now Alpharma LCC, brought an action for annulment in part of the decision at issue and reduction of the fine imposed on them by the Commission.

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

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

By the judgment under appeal, the General Court dismissed that action in its entirety.

By the judgment under appeal, the General Court dismissed that action in its entirety.

Procedure before the Court of Justice

Procedure before the Court of Justice

By document lodged at the Registry of the Court of Justice on 25 November 2016, Xellia and Alpharma LLC (‘the appellants’) brought the present appeal.

By document lodged at the Registry of the Court of Justice on 25 November 2016, Xellia and Alpharma LLC (‘the appellants’) brought the present appeal.

By documents lodged at the Registry of the Court of Justice on 28 July 2017, the United Kingdom sought leave to intervene in support of the form of order sought by the Commission in the present case and in Cases C‑586/16 P (Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission), C‑588/16 P (Generics (UK) v Commission), C‑601/16 P (Arrow Group and Arrow Generics v Commission) and C‑614/16 P (Merck v Commission), referred to in paragraph 7 of the present judgment. By orders of 25 October 2017, Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission (C‑586/16 P, not published, EU:C:2017:831), of 25 October 2017, Generics (UK) v Commission (C‑588/16 P, not published, EU:C:2017:829), of 25 October 2017, Arrow Group and Arrow Generics v Commission (C‑601/16 P, not published, EU:C:2017:826), of 25 October 2017, Xellia Pharmaceuticals and Alpharma v Commission (C‑611/16 P, not published, EU:C:2017:825) and of 25 October 2017, Merck v Commission (C‑614/16 P, not published, EU:C:2017:828), the President of the Court granted those applications. However, in the light, in particular, of the order of the President of the Court of 5 July 2017, Lundbeck v Commission (C‑591/16 P, not published, EU:C:2017:532), the latter ordered, in all of those cases, that the confidential version of the decision at issue, inter alia, was to be treated as confidential in relation to the United Kingdom, and only a non-confidential version of that decision was served on the United Kingdom.

By documents lodged at the Registry of the Court of Justice on 28 July 2017, the United Kingdom sought leave to intervene in support of the form of order sought by the Commission in the present case and in Cases C‑586/16 P (Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission), C‑588/16 P (Generics (UK) v Commission), C‑601/16 P (Arrow Group and Arrow Generics v Commission) and C‑614/16 P (Merck v Commission), referred to in paragraph 7 of the present judgment. By orders of 25 October 2017, Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission (C‑586/16 P, not published, EU:C:2017:831), of 25 October 2017, Generics (UK) v Commission (C‑588/16 P, not published, EU:C:2017:829), of 25 October 2017, Arrow Group and Arrow Generics v Commission (C‑601/16 P, not published, EU:C:2017:826), of 25 October 2017, Xellia Pharmaceuticals and Alpharma v Commission (C‑611/16 P, not published, EU:C:2017:825) and of 25 October 2017, Merck v Commission (C‑614/16 P, not published, EU:C:2017:828), the President of the Court granted those applications. However, in the light, in particular, of the order of the President of the Court of 5 July 2017, Lundbeck v Commission (C‑591/16 P, not published, EU:C:2017:532), the latter ordered, in all of those cases, that the confidential version of the decision at issue, inter alia, was to be treated as confidential in relation to the United Kingdom, and only a non-confidential version of that decision was served on the United Kingdom.

On 27 November 2018, the Court of Justice decided that the present case would be assigned to the Fourth Chamber, which was to give judgment following a joint hearing in respect of the present case and Cases C‑586/16 P (Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission), C‑588/16 P (Generics (UK) v Commission), C‑591/16 P (Lundbeck v Commission), C‑601/16 P (Arrow Group and Arrow Generics v Commission) and C‑614/16 P (Merck v Commission) and having heard an Opinion of the Advocate General.

On 27 November 2018, the Court of Justice decided that the present case would be assigned to the Fourth Chamber, which was to give judgment following a joint hearing in respect of the present case and Cases C‑586/16 P (Sun Pharmaceutical Industries and Ranbaxy (UK) v Commission), C‑588/16 P (Generics (UK) v Commission), C‑591/16 P (Lundbeck v Commission), C‑601/16 P (Arrow Group and Arrow Generics v Commission) and C‑614/16 P (Merck v Commission) and having heard an Opinion of the Advocate General.

On the basis of Article 61(2) of the Rules of Procedure of the Court of Justice, on 29 November 2018 the Court sent a set of written questions to the parties to the proceedings in the present case to be answered orally at the hearing and a provisional plan for the hearing of oral submissions which set out in detail how the hearing was to be conducted. Following the observations of the parties to the proceedings, a final plan for the hearing was sent to them on 22 January 2019.

On the basis of Article 61(2) of the Rules of Procedure of the Court of Justice, on 29 November 2018 the Court sent a set of written questions to the parties to the proceedings in the present case to be answered orally at the hearing and a provisional plan for the hearing of oral submissions which set out in detail how the hearing was to be conducted. Following the observations of the parties to the proceedings, a final plan for the hearing was sent to them on 22 January 2019.

The hearing in this case and in the cases referred to in paragraph 14 of the present judgment was held on 24 January 2019.

The hearing in this case and in the cases referred to in paragraph 14 of the present judgment was held on 24 January 2019.

On 6 February 2020, the Advocate General, on the basis of Article 62 of the Rules of Procedure, sent a question to the parties to the proceedings in the present case to be answered in writing in which she invited them to state their views on the possible effect of the judgment of 30 January 2020, Generics (UK) and Others (C‑307/18, EU:C:2020:52) on the grounds of appeal raised in the present case relating to the existence of potential competition between Lundbeck and the manufacturers of generic medicines and to the characterisation of the agreements concluded between Lundbeck and those manufacturers as ‘restrictions by object’. The replies to that question were received by the Court on 6 March 2020.

On 6 February 2020, the Advocate General, on the basis of Article 62 of the Rules of Procedure, sent a question to the parties to the proceedings in the present case to be answered in writing in which she invited them to state their views on the possible effect of the judgment of 30 January 2020, Generics (UK) and Others (C‑307/18, EU:C:2020:52) on the grounds of appeal raised in the present case relating to the existence of potential competition between Lundbeck and the manufacturers of generic medicines and to the characterisation of the agreements concluded between Lundbeck and those manufacturers as ‘restrictions by object’. The replies to that question were received by the Court on 6 March 2020.

By decision of 10 March 2020, the Court decided, following delivery of the judgment of 30 January 2020, Generics (UK) and Others (C‑307/18, EU:C:2020:52), to give judgment in the present case without an Opinion.

By decision of 10 March 2020, the Court decided, following delivery of the judgment of 30 January 2020, Generics (UK) and Others (C‑307/18, EU:C:2020:52), to give judgment in the present case without an Opinion.

Forms of order sought by the parties before the Court of Justice

Forms of order sought by the parties before the Court of Justice

By their appeal, the appellants claim that the Court of Justice should:

By their appeal, the appellants claim that the Court of Justice should:

–set aside the judgment under appeal in whole or in part;

–set aside the judgment under appeal in whole or in part;

–annul the decision at issue in whole or in part;

–annul the decision at issue in whole or in part;

–cancel or substantially reduce the fine imposed on them;

–cancel or substantially reduce the fine imposed on them;

–in the alternative, refer the case back to the General Court for determination in accordance with the judgment of the Court of Justice; and

–in the alternative, refer the case back to the General Court for determination in accordance with the judgment of the Court of Justice; and

–order the Commission to pay the costs of the present proceedings and the costs incurred before the General Court.

–order the Commission to pay the costs of the present proceedings and the costs incurred before the General Court.

The Commission contends that the Court of Justice should:

The Commission contends that the Court of Justice should:

–dismiss the appeal as being entirely unfounded;

–dismiss the appeal as being entirely unfounded;

–order the appellants to pay the costs.

–order the appellants to pay the costs.

The United Kingdom claims that the Court of Justice should dismiss the appeal in its entirety.

The appeal

In support of their appeal, the appellants rely on nine grounds.

The first ground concerns a failure to recognise the presumption of validity of Lundbeck’s new process patents as part of the assessment of the existence of potential competition between Lundbeck and the Alpharma group, and the second ground alleges a reversal of the burden of proof and reliance by the General Court, in the context of that assessment, on evidence which was not contained in the decision at issue.

The third and fourth grounds allege, respectively, mischaracterisation of the agreement at issue as a ‘restriction by object’ and a failure to assess whether the Commission proved its allegations on the scope of the restrictions laid down in the agreement at issue with respect to the Alpharma group.

The fifth to ninth grounds allege, respectively, first, an error of law in the assessment of the duration of the Commission’s inquiry and harm to the appellants’ rights of defence; second, discriminatory treatment of Alpharma LLC; third, legal uncertainty which should have precluded the imposition of a fine on the Alpharma group; fourth, a failure to take account of the gravity of the infringement in setting the amount of the fine imposed on the Alpharma group by the decision at issue; and, fifth, an error in law in that the General Court applied the wrong legal standard to determine the relevant business year to be used to determine the maximum amount of the fine that could be imposed on A.L. Industrier.

It is appropriate to start by examining the first and second grounds together, then to move on to the third and fourth grounds, also together, and finally to examine the fifth to ninth grounds in turn.

First and second grounds of appeal

The relevant paragraphs of the judgment under appeal

By their second plea raised in their action for annulment, the appellants claimed that the Commission had made several errors of law and of assessment regarding the characterisation of the Alpharma group as a potential competitor of Lundbeck.

The General Court rejected that plea in paragraphs 49 to 156 of the judgment under appeal.

As a preliminary point, the General Court summarised the analysis of potential competition carried out in the decision at issue, in which it stated the following in paragraphs 51 to 58 of the judgment under appeal:

‘51 In recitals 615 to 620 of the [decision at issue], the Commission examined the specific characteristics of the pharmaceutical sector and identified two phases in which potential competition could occur in that sector.

52 The first phase may begin several years before the impending expiry of the patent on an API, when [manufacturers of generic medicines] that want to launch a generic version of the medicinal product concerned begin developing viable processes leading to a product that meets regulatory requirements. Next, in the second phase, in order to prepare for actual market entry, a [manufacturer of generic medicines] must apply for marketing authorisations (“MAs”) for the purposes of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), order tablets from one or more [manufacturers of generic medicines] 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.

…

54 In those phases of potential competition, [manufacturers of generic medicines] 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, …

…

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

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

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

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

–had published sales prices in the United Kingdom;

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

–had reached the conclusion that the process used by Cipla to produce citalopram infringed [Lundbeck’s patent protecting the crystallisation process in the United Kingdom] but considered that it had a reasonable chance of avoiding an injunction blocking its market entry and of securing invalidation of that patent;

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

As regards the possibility that the Alpharma group might enter the market, the General Court assessed two possible routes.

With regard to the first route, namely market entry by means of tablets manufactured using the process employed by Cipla to produce citalopram (‘the Cipla process’) which the Alpharma group had already received or ordered, the General Court recalled, in paragraph 85 of the judgment under appeal, the content of an email dated 19 February 2002 from a managing director of that group (‘the email of 19 February 2002’), mentioned in recital 1027 of the decision at issue, which referred, inter alia, to applications for declarations of invalidity in respect of Lundbeck’s new process patents, which had reasonable chances of success, and alluded to the possibility of using citalopram produced via the process employed by Matrix, which he regarded as not giving rise to problems with regard to Lundbeck’s new process patents. In paragraph 88 of that judgment, the General Court inferred from the above that the Alpharma group itself acknowledged that it considered that its chances of invalidating Lundbeck’s patent protecting the crystallisation process in the United Kingdom were reasonable.

In paragraphs 91 and 92 of that judgment, the General Court noted that the Alpharma group had taken numerous steps and made significant investments in order to enter the market, which the Court listed.

In paragraph 108 of that judgment, the General Court noted that it was apparent from an Alpharma group internal email of 14 February 2002 and from the email of 19 February 2002 that that group, whilst aware of the risks that market entry might entail, would not necessarily have abandoned its plans if it had not been able to conclude a sufficiently advantageous agreement with Lundbeck.

In paragraph 123 of the judgment under appeal, the General Court added that, although the fact that, on 30 January 2002, Lundbeck obtained the patent protecting the crystallisation process in the United Kingdom surprised the Alpharma group, since it had expected Lundbeck’s application to be refused, that group continued to consider that, despite the existence of certain risks, it had a reasonable chance of having that patent annulled and that, in view in particular of the steps already taken and the investments already made, market entry thus remained a real concrete possibility, which was an alternative option to concluding a sufficiently advantageous agreement with Lundbeck.

In paragraph 132 of that judgment, the General Court held that, also according to Lundbeck, the Alpharma group had a real and concrete possibility of entering the market.

Lastly, in paragraph 136 of that judgment, that court held that the fact that it was probable that the Cipla process infringed Lundbeck’s patent protecting the crystallisation process in the United Kingdom did not represent for the Alpharma group a barrier to market entry of such magnitude that the group could not be considered to be a potential competitor of Lundbeck.

As regards the second route of market entry, by means of citalopram produced via the process used by Matrix, the General Court noted, in paragraphs 139, 143 and 154 respectively of the judgment under appeal, that the contract concluded between Tiefenbacher and the Alpharma group permitted the latter to obtain citalopram produced in accordance with the processes used by Cipla and Matrix, that the Alpharma group took the view that the process that Matrix was using at the time to produce citalopram could allow the group to enter the market without infringing Lundbeck’s patent protecting the crystallisation process in the United Kingdom, and that, on that basis, at the time of conclusion of the agreement at issue, even the switch to citalopram produced in accordance with the Matrix process constituted for the Alpharma group a real and concrete possibility of market entry.

Consequently, in paragraph 155 of the judgment under appeal, the General Court held that the Alpharma group had at least two real and concrete possibilities of entering the market and, owing to those possibilities, was exerting competitive pressure on Lundbeck.

Last, in response to the appellants’ fourth plea in support of their action for annulment, alleging an error of law as regards the finding of the existence of a ‘restriction by object’ when the agreement at issue reflected the exclusionary power of Lundbeck’s new process patents, the General Court held, inter alia, in paragraph 339 of the judgment under appeal, as follows:

‘339 … in the light of the principles deriving from the case-law set out in paragraphs 315 and 316 [of the judgment under appeal], the presumption of validity enjoyed by all patents cannot be equated with a presumption of illegality of any product placed on the market which the patent holder deems to be infringing his patent. As the Commission submits, in the present case it was for Lundbeck to prove before the national courts, in the event that generic medicinal products entered the market, that they infringed one of its process patents, since entry “at risk” by a [manufacturer of generic medicines] is not in itself unlawful. Moreover, in the context of an infringement action, the defendant could have challenged the validity of the patent on which Lundbeck relied by bringing a counter-claim. Such claims occur frequently in patent litigation and lead, in numerous cases, to a declaration of invalidity of the process patent relied on by the patent holder, as the Commission noted in recital 76 of the [decision at issue].’

Arguments of the parties

By their first ground of appeal, directed against, inter alia, paragraphs 54 and 339 of the judgment under appeal, the appellants criticise the General Court for concluding that the Alpharma group was a potential competitor of Lundbeck despite evidence which clearly showed that that group’s products infringed Lundbeck’s new process patents, which had to be presumed to be valid.

According to the appellants, it was for the General Court to satisfy itself that the Commission had submitted evidence showing to the requisite legal standard that Lundbeck’s new process patents were weak, failing which those patents had to be presumed to be valid and the entry of infringing products presumed to be unlawful. By failing to do so, the General Court allegedly infringed the basic principle that patents are to be presumed to be valid and disregarded the fact that a patent grants its holder an exclusive right and not merely a right to claim an exclusionary power by court action. In so doing, the General Court ‘dissociated’ its assessment under Article 101 TFEU from the principles deriving from patent law.

In that regard, the appellants claim that the status of being a competitor depends on whether the patent concerned is valid, which is uncertain until a final judicial decision is adopted, while maintaining that there is a presumption in competition law that patents are valid, and that presumption obliges the Commission, if it wishes to establish the existence of a restriction of competition, to demonstrate that the patent concerned is weak. In addition, they add that, if the presumption that patents are valid were not recognised, every settlement agreement would always be a restriction of competition.

The appellants argue that, in the present case, the Commission’s evidence that Lundbeck’s patent protecting the crystallisation process in the United Kingdom is weak was not examined by the General Court and cannot be established simply by referring to an email from an executive of the Alpharma group or to statements made by Lundbeck. In that regard, the Commission merely found, as is apparent from paragraph 54 of the judgment under appeal, that process patents are more vulnerable than the other types of patent.

In addition, the appellants claim that the Commission disregarded contemporaneous evidence showing that the two parties to the agreement at issue held the view that the Alpharma group’s products infringed Lundbeck’s new process patents.

By their second ground of appeal, the appellants complain that the General Court failed to verify whether the Commission had proved that, on the date of the agreement at issue, the Alpharma group actually had real possibilities of entering the market with the infringing tablets that it had purchased, thus reversing the burden of proof.

46In accordance with the judgment of 29 June 2012, E.ON Ruhrgas and E.ON v Commission (T‑360/09, EU:T:2012:332, paragraph 114), where a party is preparing to enter the market and encounters an unforeseen obstacle – in the present case, the infringing nature of its products – it is for the Commission to prove that, despite that obstacle, entry to the market remains, in spite of everything, an economically viable strategy. Thus, the appellants maintain that, in the present case, the Commission was required to prove that the probability that the Alpharma group would not succeed in litigation in respect of Lundbeck’s new process patents was relatively low in order for market entry to remain an economically viable strategy. The Commission did not adduce that evidence and merely stated that it was not certain that Lundbeck would be able to use its new process patents to block the Alpharma group’s market entry, as is apparent from recital 1039 of the decision at issue.

47Moreover, the appellants claim that the General Court reversed the burden of proof by requiring the appellants to prove that Lundbeck’s new process patents prevented market entry from being an economically viable strategy, proof which was particularly difficult to adduce given that the Commission waited six to seven years before notifying its objections to the Alpharma group.

48Furthermore, in paragraph 108 of the judgment under appeal, the General Court relied on evidence which was not contained in the decision at issue without allowing the appellants to dispute the relevance of that evidence and, therefore, infringed their rights of defence.

49The Commission claims that the first and second grounds of appeal must be dismissed.

Findings of the Court

50If the conduct of undertakings is to be subject to the prohibition in principle laid down in Article 101(1) TFEU, that conduct must not only reveal the existence of coordination between them – in other words, an agreement between undertakings, a decision by an association of undertakings or a concerted practice – but that coordination must also have a negative and appreciable effect on competition within the internal market (judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 31).

51The latter requirement means, with respect to horizontal cooperation agreements entered into by undertakings that operate at the same level of the production or distribution chain, that the coordination involves undertakings who are in competition with each other, if not in reality, then at least potentially (judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 32).

52In order to assess whether an undertaking that is not present in a market is a potential competitor of one or more other undertakings that are already present in that market, it must be determined whether there are real and concrete possibilities of the former joining that market and competing with one or more of the latter; however, that criterion does not require in any way that it be demonstrated with certainty that the former undertaking will in fact enter the market concerned and, a fortiori, that it will be capable, thereafter, of retaining its place there (judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraphs 36 and 38).

53When the agreements in question are ones which have the effect of temporarily keeping several undertakings outside a market, such as the agreement at issue, it must be determined, having regard to the structure of the market and the economic and legal context within which it operates, whether there would have existed, in the absence of those agreements, real and concrete possibilities for those undertakings to enter that market and compete with the undertakings established in that market (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraphs 37 and 39).

54Specifically, with regard to such agreements occurring in the context of the opening, to the manufacturers of generic medicines, of the market, for a medicine containing an active ingredient that has recently entered the public domain, it should be established, by taking due account of the regulatory constraints that are characteristic of the medicine sector and of the intellectual property rights and, in particular, the patents held by the manufacturers of originator medicines relating to one or more processes for the manufacture of an active ingredient that is in the public domain (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraphs 40 and 41), whether the manufacturer of generic medicines has in fact a firm intention and an inherent ability to enter the market, and does not meet barriers to entry that are insurmountable (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 58).

55In order to do so, it is necessary to assess, first, whether, at the time when those agreements were concluded, that manufacturer had taken sufficient preparatory steps to enable it to enter the market concerned within such a period of time as would impose competitive pressure on the manufacturer of originator medicines. Second, it must be determined that the market entry of such a manufacturer of generic medicines does not meet barriers to entry that are insurmountable (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraphs 43 and 45). Furthermore, a finding of potential competition between a manufacturer of generic medicines and a manufacturer of originator medicines can be confirmed by additional factors, such as the conclusion of an agreement between them at a time when the former was not present on the market concerned (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraphs 54 to 56).

56Specifically, with regard to the assessment of whether there are barriers to entry into the market concerned which are insurmountable, the Court has held that the existence of a patent which protects the manufacturing process of an active ingredient that is in the public domain cannot, as such, be regarded as such an insurmountable barrier, regardless of the presumption of validity attached to that patent, since that presumption sheds no light, for the purposes of applying Articles 101 and 102 TFEU, on the outcome of any dispute in relation to the validity of that patent (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraphs 46 to 51).

57Consequently, the existence of such a patent does not, as such, mean that a manufacturer of generic medicines who has in fact a firm intention and an inherent ability to enter the market, and who, by the steps taken, shows a readiness to challenge the validity of that patent and to take the risk, upon entering the market, of being subject to infringement proceedings brought by the patent holder, cannot be characterised as a ‘potential competitor’ of the manufacturer of originator medicines concerned (judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 46).

58Furthermore, the Court has also held that it is not for the competition authority concerned to carry out a review of the strength of the patent at issue or of the probability of a dispute between the patent holder and a manufacturer of generic medicines being brought to an end with a finding that that patent is valid and has been infringed (judgment of 30 January 2020, Generics (UK) and Others, C‑307/18, EU:C:2020:52, paragraph 50).

59In the present case, it is apparent from the judgment under appeal – specifically, from paragraphs 58, 85, 91, 92, 123, 139, 143 and 154 thereof – that not only had the Alpharma group taken numerous steps to obtain MAs and made significant investments in order to enter the generic citalopram market, but also that it had at least two real and concrete possibilities of entering the market at the time the agreement at issue was concluded. The first, namely market entry with tablets manufactured using the Cipla process, which the Alpharma group had received or ordered from Tiefenbacher, had not been called into question by the new information brought to the attention of the Alpharma group in January and February 2002 as to whether the Cipla process was potentially infringing. The second possibility was that of entering the market with citalopram tablets manufactured via the Matrix process, which entailed no risk of infringement; the Alpharma group did not have such tablets at its disposal, but could obtain them in the short term through its contract with Tiefenbacher.

60In addition, the General Court held, in paragraphs 88 and 136 of the judgment under appeal, that the Alpharma group considered that Lundbeck’s patent protecting the crystallisation process in the United Kingdom did not constitute a barrier to its market entry and that, in the event of litigation, that group had reasonable chances of having that process patent annulled.

61Moreover, the General Court noted, in paragraph 132 of that judgment, that, according to Lundbeck itself, the Alpharma group was a potential competitor.