JUDGMENT OF THE GENERAL COURT (Ninth Chamber, Extended Composition)

12 December 2018 ( *1 )

(Competition — Agreements, decisions and concerted practices — Abuse of a dominant position — Market for perindopril, a medicinal product intended for the treatment of cardiovascular diseases, in its originator and generic versions — Decision finding an infringement of Articles 101 and 102 TFEU — Principle of impartiality — Consultation of the Advisory Committee on Restrictive Practices and Dominant Positions — Right to an effective remedy — Brevity of the period of time for lodging applications in the light of the length of the contested decision — Patent dispute settlement agreements — Licensing agreements — Technology acquisition agreements — Exclusive purchasing agreement — Potential competition — Restriction of competition by object — Restriction of competition by effect — Balance between competition law and patent law — Classification as separate infringements or as a single infringement — Definition of the relevant market at the level of the compound of the medicinal product concerned — Fines — Imposition of cumulative fines under Articles 101 and 102 TFEU — Principle that offences and penalties must have a proper legal basis — Value of sales — Method of calculation in the event of cumulative infringements on the same markets)

In Case T‑691/14,

Servier SAS, established in Suresnes (France),

Servier Laboratories Ltd, established in Wexham (United Kingdom),

Les Laboratoires Servier SAS, established in Suresnes,

represented initially by I.S. Forrester QC, J. Killick, Barrister, O. de Juvigny, lawyer, and M. Utges Manley, Solicitor, and subsequently by J. Killick, O. de Juvigny, M. Utges Manley, J. Jourdan and T. Reymond, lawyers,

applicants,

supported by

European Federation of Pharmaceutical Industries and Associations (EFPIA), established in Geneva (Switzerland), represented by F. Carlin, Barrister, N. Niejahr and C. Paillard, lawyers,

intervener,

v

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

defendant,

APPLICATION under Article 263 TFEU for annulment of Commission Decision C(2014) 4955 final of 9 July 2014 relating to a proceeding under Article 101 and Article 102 TFEU [Case AT.39612 — Perindopril (Servier)] in so far as it concerns the applicants and, in the alternative, for reduction of the fine imposed on the applicants by that decision,

THE GENERAL COURT (Ninth Chamber, Extended Composition),

composed of S. Gervasoni (Rapporteur), President, E. Bieliūnas, L. Madise, R. da Silva Passos and K. Kowalik-Bańczyk, Judges,

Registrar: G. Predonzani, Administrator,

having regard to the written part of the procedure and further to the hearing on 6 to 9 June 2017,

gives the following

Judgment ( 1 )

I. Background to the dispute

A. The applicants

1 The Servier group, composed, inter alia, of Servier SAS, its parent company established in France, Les Laboratoires Servier SAS and Servier Laboratories Ltd (individually or jointly, ‘Servier’ or ‘the applicants’), brings together pharmaceutical companies at the global level. Stichting FIRS, a non-profit foundation under Netherlands law, has exclusive control over the operation of the group’s parent company.

B. Perindopril and its patents

1. Perindopril

2 Servier developed perindopril, a medicinal product used in cardiovascular medicine, primarily intended for the treatment of hypertension and heart failure, by inhibiting the angiotensin converting enzyme (‘ACE’).

3 The active pharmaceutical ingredient of perindopril (‘API’), that is to say, the biologically active chemical substance which produces the desired therapeutic effects, takes the form of a salt. The salt used initially was erbumine (or tert-butylamine), which is in its crystalline form on account of the synthesis process applied by Servier.

2. Compound patent

4 The perindopril compound patent (patent EP0049658, ‘the 658 patent’) was filed with the European Patent Office (EPO) on 29 September 1981. The 658 patent was due to expire on 29 September 2001, but protection was prolonged in a number of EU Member States, including the United Kingdom, until 22 June 2003, in accordance with 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). In France, protection under the 658 patent was prolonged until 22 March 2005 and, in Italy, until 13 February 2009.

3. Secondary patents

5 In 1988, Servier also filed a number of patents before the EPO relating to processes for the manufacture of the perindopril compound with an expiry date of 16 September 2008: patents EP0308339, EP0308340, EP0308341 and EP0309324 (respectively, ‘the 339 patent’, ‘the 340 patent’, ‘the 341 patent’ and ‘the 324 patent’).

6 Servier filed new patents relating to erbumine and its manufacturing processes with the EPO in 2001, including patent EP1294689 (known as ‘the beta patent’ — ‘the 689 patent’), patent EP1296948 (known as ‘the gamma patent’ — ‘the 948 patent’), and patent EP1296947 (known as ‘the alpha patent’ — ‘the 947 patent’).

7 The 947 patent application relating to the alpha crystalline form of erbumine and the process for its preparation was filed on 6 July 2001 and granted by the EPO on 4 February 2004.

8 Servier also filed national patent applications in several EU Member States before they were parties to the Convention on the Grant of European Patents, which was signed in Munich on 5 October 1973 and entered into force on 7 October 1977 (‘the EPC’). Servier filed, for example, patent applications relating to the 947 patent in Bulgaria (BG 107532), the Czech Republic (PV 2003-357), Estonia (P200300001), Hungary (HU225340), Poland (P348492) and Slovakia (PP0149-2003). All the patent applications in question were filed on the same date: 6 July 2001. The patents were granted on 16 May 2006 in Bulgaria, on 17 August 2006 in Hungary, on 23 January 2007 in the Czech Republic, on 23 April 2007 in Slovakia and on 24 March 2010 in Poland.

4. Second generation perindopril

9 From 2002, Servier began developing a second generation perindopril product, manufactured using another salt, arginine, instead of erbumine. Perindopril arginine showed improvements in terms of shelf life, which increased from two to three years; stability, enabling the use of a single type of packaging for all climatic zones; and storage, since it required no particular storage conditions.

10 Servier applied for a European patent for perindopril arginine (patent EP1354873B, ‘the 873 patent’) on 17 February 2003. The 873 patent was granted to Servier on 17 July 2004 with an expiry date of 17 February 2023. The introduction of perindopril arginine in the European Union markets started in 2006.

C. Disputes relating to perindopril

1. Disputes before the EPO

11 Ten generic companies, including Niche Generics Ltd (‘Niche’), Krka Tovarna Zdravil d.d. (‘Krka’), Lupin Ltd and Norton Healthcare Ltd, a subsidiary of Ivax Europe (‘Ivax’) which subsequently merged with Teva Pharmaceuticals Ltd (individually or together with other members of the Teva group, ‘Teva’), filed opposition proceedings against the 947 patent before the EPO in 2004, seeking the revocation in full of that patent on grounds of lack of novelty, lack of inventive step and insufficient disclosure of the invention.

12 On 27 July 2006, the Opposition Division of the EPO confirmed the validity of the 947 patent after Servier made some minor amendments to its original claims (‘the EPO decision of 27 July 2006’). Seven companies brought an appeal against that decision. Niche withdrew from the opposition procedure on 9 February 2005, Krka on 11 January 2007 and Lupin on 5 February 2007. By decision of 6 May 2009, the EPO’s Technical Board of Appeal annulled the EPO decision of 27 July 2006 and revoked the 947 patent. Servier’s request for a revision of that decision was rejected on 19 March 2010.

13 On 11 August 2004, Niche also filed an opposition against the 948 patent before the EPO, but withdrew from the procedure on 14 February 2005.

14 On 13 April 2005, Teva filed opposition proceedings against the 873 patent. The Opposition Division rejected that opposition on the ground that Teva had not demonstrated that that patent had insufficient inventive step. On 22 December 2008, Teva filed an appeal against that decision, before withdrawing the appeal on 8 May 2012.

2. Disputes before the national Courts

15 The validity of the 947 patent has, moreover, been challenged by generic companies before the courts of certain Member States, notably in the Netherlands and the United Kingdom.

(a) Dispute between Servier and Niche and Servier and Matrix

16 In the United Kingdom, on 25 June 2004, Servier brought an action for infringement before the High Court of Justice (England & Wales), Chancery Division (Patents Court), against Niche, in relation to the 339, 340 and 341 patents, after Niche applied for marketing authorisations in the United Kingdom for a generic version of perindopril, developed in partnership with Matrix Laboratories Ltd (‘Matrix’) under an agreement concluded on 26 March 2001 (‘the Niche-Matrix agreement’). On 9 July 2004 Niche served on Servier a counterclaim for a declaration of invalidity of the 947 patent.

17 The hearing before the High Court of Justice (England & Wales), Chancery Division (Patents Court), concerning the merits of the alleged infringement, was finally scheduled for 7 and 8 February 2005, but lasted for only half a day because a settlement agreement was concluded between Servier and Niche on 8 February 2005, which put an end to the litigation between those parties.

18 Matrix was kept informed by Niche on the progress of that litigation procedure and was also associated with that procedure as it gave evidence before the High Court of Justice (England & Wales), Chancery Division (Patents Court), on behalf of Niche. Moreover, on 7 February 2005, Servier sent a formal warning letter to Matrix, accusing it of infringing the 339, 340 and 341 patents and threatening to bring an action for infringement.

19 In the autumn of 2004, Servier began to consider acquiring Niche. To that end, Servier carried out a due diligence, of which the first phase was completed on 10 January 2005, the date on which Servier submitted a preliminary non-binding offer to acquire Niche’s capital for an amount between 15 and 45 million pounds sterling (GBP). Following the second phase of the due diligence, which took place on 21 January 2005, Servier informed Niche verbally on 31 January 2005 that it did not wish to proceed with the acquisition.

(b) Disputes between Servier and Ivax and Servier and Teva

20 In the United Kingdom, on 9 August 2005, Ivax requested the revocation of the 947 patent before the High Court of Justice (England & Wales), Chancery Division (Patents Court). In October 2005, Servier and Ivax decided, however, to stay the proceedings until the adoption of the final decision in the opposition proceedings before the EPO. In return, Servier gave Ivax, its licensees and its customers an undertaking that, for the period of the stay and in the United Kingdom, it would not commence proceedings, seek an account of profits or any financial relief other than a reasonable royalty in respect of any acts of infringement of the 947 patent, or seek injunctive relief or delivery up. Servier also undertook to continue proceedings before the EPO diligently and not to seek an interim injunction in any infringement action brought once the proceedings before the EPO had been concluded.

21 In the Netherlands, on 15 August 2007, Pharmachemie BV, a Teva subsidiary, brought an action before the Rechtbank Den Haag (District Court, The Hague, Netherlands) for revocation of the 947 patent, as validated in the Netherlands, on grounds of lack of novelty and inventive step and for non-reproducibility. The Rechtbank Den Haag (District Court, The Hague) upheld that action on 11 June 2008. Servier appealed against that judgment on 7 October 2008 but did not subsequently submit a statement of objections.

(c) Disputes between Servier and Krka

22 In Hungary, on 30 May 2006, Servier applied for an interim injunction preventing the marketing of a generic version of perindopril placed on the market by Krka, as a result of the infringement of the 947 patent. That application was rejected in September 2006.

23 In the United Kingdom, on 28 July 2006, Servier brought an action for infringement of the 340 patent against Krka before the High Court of Justice (England & Wales), Chancery Division (Patents Court). On 2 August 2006, it also brought an action for infringement of the 947 patent against Krka and applied for an interim injunction. On 1 September 2006, Krka brought a counterclaim for annulment of the 947 patent and, on 8 September 2006, a separate counterclaim for annulment of the 340 patent. On 3 October 2006, the High Court of Justice (England & Wales), Chancery Division (Patents Court), granted Servier’s application for an interim injunction and denied the motion for summary judgment brought by Krka on 1 September 2006 seeking the invalidation of the 947 patent. On 1 December 2006, the infringement proceedings were discontinued as a result of the settlement reached between the parties and the interim injunction was lifted.

(d) Dispute between Servier and Lupin

24 On 18 October 2006, Lupin submitted an application to the High Court of Justice (England & Wales), Chancery Division (Patents Court), for a declaration of invalidity of the 947 patent, as validated in the United Kingdom, and a declaration that the generic version of perindopril which it intended to market in the United Kingdom did not infringe that patent.

(e) Disputes between Servier and Apotex

25 In the United Kingdom, Servier brought an action for infringement before the High Court of Justice (England & Wales), Chancery Division (Patents Court), against the company Apotex Inc. on 1 August 2006, claiming infringement of the 947 patent, since Apotex had launched a generic version of perindopril in the United Kingdom on 28 July 2006. Apotex brought a counterclaim for annulment of that patent. An interim injunction prohibiting Apotex from importing, offering to sell or selling perindopril was obtained on 8 August 2006. On 6 July 2007, the High Court of Justice (England & Wales), Chancery Division (Patents Court), ruled that the 947 patent was invalid because it lacked novelty and inventive step over the 341 patent. Consequently, the injunction was lifted immediately and Apotex was able to resume selling its generic version of perindopril on the United Kingdom market. On 9 May 2008, the Court of Appeal (England & Wales) (Civil Division) dismissed Servier’s appeal against the judgment of the High Court of Justice (England & Wales), Chancery Division (Patents Court).

26 On 9 October 2008, the High Court of Justice (England & Wales), Chancery Division (Patents Court), awarded damages to Apotex in the amount of GBP 17.5 million on account of the loss of revenue suffered during the period when the injunction was in force. On 29 March 2011, however, the High Court of Justice (England & Wales), Chancery Division (Patents Court), ordered Apotex to repay that sum to Servier on the basis of the ex turpi causa principle, since a valid Canadian patent protected the perindopril compound until 2018 and Apotex produced and sold its product in Canada. However, the Court of Appeal (England and Wales) (Civil Division) set aside that decision by judgment of 3 May 2012. On 29 October 2014, the Supreme Court of the United Kingdom dismissed Servier’s appeal against the judgment of the Court of Appeal (England and Wales) (Civil Division).

27 In the Netherlands, on 13 November 2007, Katwijk Farma BV, an Apotex subsidiary, brought an action before the Rechtbank Den Haag (District Court, The Hague) for annulment of the 947 patent, as validated in the Netherlands. Servier applied for an interim injunction against Katwijk Farma on 7 December 2007, which was rejected by the Rechtbank Den Haag (District Court, The Hague) on 30 January 2008. Following the annulment of the 947 patent for the Netherlands on 11 June 2008 by the Rechtbank Den Haag (District Court, The Hague) in the context of the action brought by Pharmachemie BV, Servier and Katwijk Farma withdrew from the ongoing proceedings.

D. Patent dispute settlements

28 Servier entered into a series of patent settlement agreements with a number of generic companies with which it was involved in patent disputes. However, it did not enter into a settlement agreement with Apotex.

1. Agreements concluded by Servier with Niche and Unichem and with Matrix

29 On 8 February 2005, Servier concluded two settlement agreements, one with Niche and its parent company, Unichem Laboratories Ltd (‘Unichem’), and the other with Matrix. On the same day, Niche concluded a licensing and supply agreement with Biogaran, a wholly-owned subsidiary of Les Laboratoires Servier.

30 The agreement concluded by Servier with Niche and Unichem (‘the Niche agreement’) covered all the countries in which the 339, 340, 341 and 947 patents existed (Clause 3).

31 Under the Niche agreement, Niche and Unichem were to refrain from making, having made, keeping, importing, supplying, offering to supply or disposing of generic perindopril made using the process developed by Niche, which Servier regarded as infringing the 339, 340 and 341 patents, as validated in the United Kingdom, using a substantially similar process or using any other process that would infringe the 339, 340 and 341 patents (‘the process at issue’) until the local expiry date of those patents (Clause 3). However, they would be free, under the Niche agreement, to market perindopril made using the process at issue without infringing the patents after the expiry of those patents (Clauses 4 and 6). Moreover, Niche was required to cancel, terminate or suspend until the expiry date of the patents all of its existing contracts relating, on the one hand, to perindopril made using the process at issue and, on the other, to marketing authorisation applications for that perindopril (Clause 11). Furthermore, Niche and Unichem undertook not to make any applications for marketing authorisations for perindopril made using the process at issue and not to assist any third parties to obtain such a marketing authorisation (Clause 10). Lastly, they were to abstain from any invalidity and non-infringement actions against the 339, 340, 341, 947, 689 and 948 patents until their expiry, except as a defence to a patent infringement action (Clause 8). Niche also agreed to withdraw its oppositions to the 947 and 948 patents before the EPO (Clause 7).

32 In return, Servier undertook, first, not to bring any infringement actions against Niche, Niche customers or Unichem based on the 339, 340, 341 and 947 patents in respect of any act of alleged infringement occurring before the conclusion of the Niche agreement (Clause 5) and, secondly, to pay Niche and Unichem the sum of GBP 11.8 million in two instalments (Clause 13). That sum was to be paid in consideration for the commitments made by Niche and Unichem and for the ‘substantial costs and potential liabilities that may be incurred by Niche and Unichem as a consequence of ceasing their programme to develop perindopril made using the process [at issue]’.

33 Moreover, on 8 February 2005, Niche concluded a licensing and supply agreement with Biogaran (‘the Biogaran agreement’), relating to the transfer, first, of all the information and data which Niche held concerning three medicinal products and which were necessary to obtain marketing authorisations and, secondly, of its French marketing authorisation for one of those medicinal products. In return, Biogaran was to pay Niche the sum of GBP 2.5 million, which was non-refundable even if Biogaran failed to obtain the marketing authorisations. Biogaran was also required, after obtaining its marketing authorisations, to order the products concerned from Niche. In the event that the marketing authorisations were not obtained within 18 months of the date of entry into force of the agreement, that agreement would be automatically terminated (Clause 14.4), without either party being entitled to any compensation (Clause 14.5).

34 The agreement concluded by Servier with Matrix (‘the Matrix agreement’) covered all the countries in which the 339, 340, 341 and 947 patents existed, with the exception of one non-Member State of the European Economic Area (EEA) (Section 1(1)(xiii) of the Matrix agreement).

35 Under the Matrix agreement, Matrix committed to refrain from making, having made, keeping, importing, supplying, offering to supply or disposing of perindopril made using the process at issue until the local expiry date of those patents (Clauses 1 and 2). However, the agreement stipulated that Matrix would be free to deal in perindopril made using the process at issue without infringing the patents after the expiry of those patents (Clause 4). Moreover, Matrix was required to cancel, terminate or suspend until the expiry date of the patents all of its existing contracts relating to perindopril made using the process at issue and to marketing authorisation applications for that perindopril by 30 June 2005 at the latest (Clauses 7 and 8). Furthermore, it committed not to apply for marketing authorisations for perindopril made using the process at issue and not to assist any third parties to obtain such a marketing authorisation (Clause 6). Finally, Matrix was to abstain from any invalidity and non-infringement actions against the 339, 340, 341, 947, 689 and 948 patents until their expiry, except as a defence to a patent infringement action (Clause 5).

36 In return, Servier committed, first, not to bring any infringement actions against Matrix, based on the 339, 340, 341 and 947 patents, in respect of any act of alleged infringement occurring before the conclusion of the Matrix agreement (Clause 3) and, secondly, to pay Matrix the sum of GBP 11.8 million in two instalments (Clause 9). That sum was consideration for the commitments made by Matrix and for the ‘substantial costs and potential liabilities that may be incurred by Matrix as a consequence of ceasing its programme to develop and manufacture perindopril made using the process [at issue]’.

2. Agreement concluded by Servier with Teva

37 On 13 June 2006, Servier concluded a settlement and exclusive purchasing agreement with Teva (‘the Teva agreement’). The perindopril referred to in the Teva agreement was perindopril erbumine (Clause 1.12).

38 Under the clauses concerning the settlement agreement, Teva undertook to destroy all perindopril owned or controlled by it and intended for sale in the United Kingdom (Clause 2.2). Moreover, Teva was to refrain, in the United Kingdom, from making, having made, keeping, importing, supplying, offering to supply or disposing of generic perindopril either manufactured in accordance with the process it had developed, which was considered by Servier to infringe the 947 and 339 to 341 patents, as validated in the United Kingdom, or infringing those patents until the termination or expiration of the Teva agreement or the expiration of those patents (Clause 2.3). Furthermore, Teva undertook not to challenge the abovementioned patents in the United Kingdom for the duration of the Teva agreement, it being stipulated that Teva was not prevented from continuing opposition proceedings against the disputed patents before the EPO (Clause 2.4).

39 In return for Teva’s undertakings, Servier undertook to waive any claims against Teva in respect of any infringement of the disputed patents in the United Kingdom prior to the entry into force of the Teva agreement (Clause 2.1).

40 Under the clauses concerning the exclusive purchasing obligation, Teva undertook to purchase exclusively from Servier all of its requirements for generic perindopril intended for distribution in the United Kingdom for the duration of the Teva agreement (Clauses 3.1 and 1.14). In the case of failure to supply by Servier, Teva had no other right of remedy or termination, but the right to payment of liquidated damages of GBP 500000 per month (Clauses 1.8 and 3.8.3).

41 Under the general provisions of the Teva agreement, that agreement had a duration of three years and was renewable for an additional two year period (Clauses 8.1 and 8.2). Moreover, on signature of the Teva agreement, upon presentation of an ‘appropriate invoice’, Servier had to pay Teva GBP 5 million as a ‘contribution towards the costs incurred by Teva in preparing to enter into this Agreement, including, without limitation, the costs of terminating its existing supply arrangements for the United Kingdom’ (Clause 10).

42 On 23 February 2007, Servier and Teva concluded an amendment to the Teva agreement (‘the amendment to the Teva agreement’), confirming the actual implementation of the exclusive purchasing obligation by setting a date on which Teva could start to distribute the generic perindopril supplied by Servier. That date either had to be set unilaterally by Servier, or it had to correspond to the date of revocation or expiry of the 947 patent, or be the date on which Apotex commenced distribution of generic perindopril in the United Kingdom following the settlement of its dispute with Servier.

3. Agreements concluded by Servier with Krka

43 On 27 October 2006, Servier entered into a settlement agreement and a licence agreement with Krka, supplemented by an amendment made on 2 November 2006.

44 The settlement agreement with Krka provides that the 947 patent also covers equivalent national patents (Annex B).

45 In accordance with the settlement agreement with Krka, in force until the expiry or the revocation of the 947 or 340 patents, Krka undertook to withdraw any existing claim against the 947 patent worldwide and against the 340 patent in the United Kingdom, and not to challenge either of those patents worldwide in the future (Clause I(ii)). Moreover, Krka and its subsidiaries were not authorised to launch or to market any generic form of perindopril which would infringe the 947 patent for the duration of the validity of that patent and in the country in which it was still valid, unless otherwise expressly authorised by Servier (Clause V). Similarly, Krka could not supply to any third party a generic version of perindopril that would infringe the 947 patent, unless otherwise expressly authorised by Servier (Clause V(2)). In return, Servier was required to withdraw the proceedings pending worldwide against Krka based on the infringement of the 947 and the 340 patents, including its applications for interim injunction (Clause I(i)).

46 Pursuant to the licence agreement concluded with Krka for a period corresponding to the validity of the 947 patent (Article 5), Servier granted Krka an exclusive, irrevocable licence on the 947 patent to use, manufacture, sell, offer for sale, promote and import its own products which contain the alpha crystalline form of erbumine (Article 2) in the Czech Republic, Latvia, Lithuania, Hungary, Poland, Slovenia and Slovakia (Article 1). In return, Krka was required to pay Servier 3% royalties on its net sales prices throughout those territories (Article 3). Servier was entitled, in those States, to use the 947 patent directly or indirectly (that is to say for one of its subsidiaries or for one third party per country) (Article 2).

47 On 5 January 2007, Servier also entered into an assignment and licence agreement with Krka.

48 Pursuant to the assignment and licence agreement, Krka assigned two patent applications to Servier, one concerning a process for the preparation of perindopril (WO 2005 113500) and the other the preparation of formulations of perindopril (WO 2005 094793) (Article 1). The technology protected in those patent applications was used for the production of Krka’s perindopril.

49 Krka undertook not to challenge the validity of any patents granted on the basis of the applications at issue (Article 3).

50 In return for that assignment, Servier paid Krka EUR 15 million for each of the applications at issue (Article 2).

51 Servier also granted Krka a non-exclusive, irrevocable, non-assignable, royalty-free licence, with no right to sub-license (other than to its subsidiaries) on the applications or resulting patents, that licence being unrestricted in time, territory or scope of use (Article 4).

4. Agreement concluded by Servier with Lupin

52 On 30 January 2007, Servier entered into a settlement agreement with Lupin (‘the Lupin agreement’).

53 Both parties thus decided to bring an end to the disputes between them concerning perindopril (Clauses 1.1, 1.2 and 1.4).

54 Moreover, Lupin undertook not to directly or indirectly seek or assist or procure any third party to revoke, invalidate or challenge the 947 patent or any patent held by Servier or its subsidiaries protecting perindopril, in any country other than a specific non-Member State of the EEA (Clause 1.3). Furthermore, Lupin and its subsidiaries were to refrain from selling or offering for sale any pharmaceutical product containing, as an API, ‘perindopril[-]erbumine … and any salt thereof’ in any country other than a specific non-EEA Member State (Clause 1.6). Lupin was, however, authorised to market products supplied by Servier or its own perindopril in countries where a generic version of perindopril authorised by Servier was on the market or in the event that all Servier’s relevant patents had expired or in countries in which a third party had placed a generic version of perindopril on the market and in which Servier had not brought any application for injunction seeking the prohibition of its sale (Clauses 1.6 and 4.1).

55 Moreover, in the context of the Lupin agreement, Servier and Lupin also concluded an agreement for the assignment of intellectual property rights and a licence agreement.

56 Servier acquired three perindopril process patent applications filed by Lupin: – application W0 2004/075889 (EP 1603558 B1) relating to a new process for the preparation of perindopril and salts thereof for EUR 20 million; – application W0 2006/097941 (EP 1861367 A) relating to a new and improved process for the purification of perindopril for EUR 10 million; – application W0 2005/037788 (EP 1675827 A1) relating to a new process for the preparation of ‘crystalline perindopril erbumine’ for EUR 10 million.

57 Servier also granted Lupin a non-exclusive, non-transferable, non-sublicensable, royalty-free, perpetual and irrevocable licence on those three patent applications for the purposes of manufacturing perindopril in the countries covered by the applications at issue (Clause 3.1).

58 The Lupin agreement provided, lastly, for the conclusion, within four weeks, of a supply contract between the parties, which was not, however, concluded.

E. The acquisition of enabling technologies

59 On 3 September 2001, the applicants concluded an agreement with Rolabo SL concerning the sale of a patent application filed by Rolabo on 24 July 2001, relating to a perindopril API and to a chemical dossier for the perindopril API, for 10 million US dollars (USD).

60 On 9 November 2004, the applicants concluded with Azad Pharmaceutical Ingredients AG (‘Azad’) an agreement to assign a patent application filed by Azad for two new polymorphic forms of perindopril, the delta and epsilon forms, and the related know-how worldwide, for an amount of EUR 13374243.

61 On 15 October 2007, the applicants concluded a memorandum of understanding with Sandoz AG, which provided that they would proceed with the acquisition of the perindopril API technology developed by Sandoz — if that technology proved to be a patent-free and industrially viable source of competition — for an amount possibly exceeding USD 50 million. Negotiations continued until July 2008, but no agreement was ultimately concluded.

F. The Sector Inquiry

62 On 15 January 2008, the Commission of the European Communities decided to open an inquiry into the pharmaceutical sector pursuant to Article 17 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) in order to identify the factors contributing to the decline in innovation in that sector, measured by the number of new medicines reaching the market, and the reasons for the delayed entry into the market of certain generic medicines.

63 The Commission published a preliminary report on the results of its inquiry on 28 November 2008, followed by a public consultation. On 8 July 2009, it adopted a communication giving a summary of its pharmaceutical sector inquiry report. The Commission stated, inter alia, in that communication, that the monitoring of patent settlements concluded between originator companies and generic companies should continue in order better to understand the use of that type of agreement and to identify those agreements that delay generic market entry to the detriment of EU consumers and may constitute an infringement of competition rules. The Commission subsequently published six annual reports on the monitoring of patent settlement agreements.

G. The administrative procedure and the contested decision

64 On 24 November 2008, the Commission made unannounced inspections, inter alia, of Servier’s premises. The Commission sent requests for information to several companies, including Servier, in January 2009. On 2 July 2009 the Commission decided to open proceedings.

65 In August 2009 and then between December 2009 and May 2012, the Commission sent new requests for information to Servier. As the latter refused to respond to certain parts of the requests for information of 7 February and 11 April 2011 relating to the Biogaran agreement, the Commission adopted a decision based on the provisions of Article 18(3) of Regulation No 1/2003. Servier provided the requested information on 7 November 2011.

66 Between 2009 and 2012, Servier was invited to attend a number of state of play meetings.

67 On 27 July 2012, the Commission issued a Statement of Objections to several companies including Servier, which submitted its reply on 14 January 2013.

68 Following the hearing of the companies concerned on 15, 16, 17 and 18 April 2013, further state of play meetings were arranged and additional requests for information sent to Servier.

69 On 18 December 2013, the Commission granted Servier access to evidence gathered or more widely disclosed after the Statement of Objections and sent a Letter of Facts to which Servier replied on 31 January 2014. The hearing officer issued his final report on 7 July 2014.

70 On 9 July 2014, the Commission adopted Decision C(2014) 4955 final relating to a proceeding under Article 101 and Article 102 TFEU [Case AT.39612 — Perindopril (Servier)] (‘the contested decision’), which was notified to the applicants on 11 July 2014.

71 The Commission considered that the applicants had infringed, first, Article 101 TFEU by participating in five patent settlement agreements with reverse payments (Articles 1 to 5 of the contested decision) and, secondly, Article 102 TFEU by drawing up and implementing — by means of technology acquisition and those five settlement agreements — an exclusionary strategy covering the market for formulations of perindopril in France, the Netherlands, Poland and the United Kingdom and the market for perindopril API technology (Article 6 of the contested decision).

72 For the infringements of Article 101 TFEU, the Commission imposed the following fines on the applicants, totalling EUR 289727200 (Article 7(1) to (5) of the contested decision): – in respect of the Niche agreement: EUR 131532600, jointly and severally with Biogaran; – in respect of the Matrix agreement: EUR 79121700; – in respect of the Teva agreement: EUR 4309000; – in respect of the agreements concluded with Krka: EUR 37661800; – in respect of the Lupin agreement: EUR 37102100.

73 For the infringement of Article 102 TFEU, the Commission imposed on the applicants a fine of EUR 41270000 (Article 7(6) of the contested decision).

II. Procedure and forms of order sought by the parties

74 By application lodged at the Registry of the General Court on 21 September 2014, the applicants brought the present action.

75 The applicants claim that the Court should: – annul, in whole or in part, Articles 1 to 8 of the contested decision in so far as they concern them; – in the alternative, annul or reduce by a very substantial amount the fines imposed on them; – grant them the benefit of any annulment, in whole or in part, of the contested decision in the actions brought by Biogaran and the other addressees of that decision; – order the Commission to pay the costs.

76 The Commission contends that the Court should: – dismiss the action; – order the applicants to pay the costs.

77 By document lodged on 2 February 2015, the European Federation of Pharmaceutical Industries and Associations (EFPIA) (‘the EFPIA’ or ‘the intervener’) sought leave to intervene in the proceedings in support of the form of order sought by the applicants.

78 The Commission requested confidential treatment, vis-à-vis the EFPIA, of certain elements of the application, the defence, the reply, the rejoinder, the response to certain measures of organisation of procedure, the observations relating to those responses and the applicants’ observations on the statement in intervention.

79 By order of the President of the Second Chamber of the Court of 14 October 2015, the EFPIA was granted leave to intervene in the present proceedings in support of the form of order sought by the applicants. Since the EFPIA did not challenge the requests for confidential treatment, the Court did not rule on whether they were well founded.

80 The intervener claims that the Court should: – annul the contested decision in so far as it concerns the applicants; – order the Commission to bear the costs of the intervener.

81 In the context of the measures of organisation of procedure provided for in Article 89(3)(a) and (d) of the Rules of Procedure of the General Court, the Commission was invited to respond in writing to questions and to produce documents relating, inter alia, to the consultation of the Advisory Committee on Restrictive Practices and Dominant Positions, to the calculation of the amount of the fine and to data concerning the agreements with Krka which were made confidential in the contested decision. It sent its replies within the prescribed period.

82 Following a change in the composition of the Chambers of the Court, the Judge-Rapporteur was assigned to the Ninth Chamber, to which the present case was accordingly allocated.

83 Acting on a proposal from the Ninth Chamber, the Court decided, pursuant to Article 28 of the Rules of Procedure, to assign the case to a Chamber sitting in extended composition.

84 Acting on a proposal from the Judge-Rapporteur, the Court decided to open the oral part of the procedure and, by way of measures of organisation of procedure pursuant to Article 89(3)(a) of the Rules of Procedure, put written questions to the parties, requesting them to answer those questions at the hearing.

85 On 24 February 2017, the parties were invited by the Court to attend an informal meeting, under Article 89(3)(e) of the Rules of Procedure, before the President of the Ninth Chamber (Extended Composition) of the General Court and Judge-Rapporteur, with a view to discussing the arrangements for the hearing and the confidential treatment of certain information. The applicants and the Commission attended that meeting, which was held at the Court on 3 May 2017.

86 At the hearing held from 6 to 9 June 2017, the parties presented oral argument and their answers to the written and oral questions put by the Court.

III. Law

A. Admissibility

1. Admissibility of the third head of claim

(a) Arguments of the parties

…

(b) Findings of the Court

89 According to settled case-law, the conditions for the admissibility of an action concern an absolute bar to proceeding with the action which the Courts of the European Union may and must consider of their own motion should such an issue arise (judgments of 21 March 2002, Joynson v Commission, T‑231/99, EU:T:2002:84, paragraph 154, and of 14 December 2005, Honeywell v Commission, T‑209/01, EU:T:2005:455, paragraph 53). Therefore, even if the Commission, in its pleadings, did not dispute the admissibility of the applicants’ third head of claim, but did so only at the hearing in response to a question from the Court, it is for the Court to consider of its own motion the admissibility of that head of claim.

90 Under the first paragraph of Article 21 of the Statute of the Court of Justice of the European Union, applicable to the procedure before the General Court by virtue of the first paragraph of Article 53 thereof, and Article 44(1)(c) and (d) of the Rules of Procedure of the General Court of 2 May 1991, applicable at the time the action was brought, each application is required to state the subject matter of the proceedings, the form of order sought and a summary of the pleas in law on which the application is based. The purpose of that requirement is to obtain sufficiently clear and precise information to enable the defendant to defend itself properly and the EU judicature to exercise its power of review, if necessary without any further supporting information (judgments of 29 June 1995, ICI v Commission, T‑37/91, EU:T:1995:119, paragraph 42; of 24 February 2000, ADT Projekt v Commission, T‑145/98, EU:T:2000:54, paragraph 66; and of 16 March 2004, Danske Busvognmænd v Commission, T‑157/01, EU:T:2004:76, paragraph 45). Thus, as the Commission argued at the hearing, a general reference in the application to the pleas and arguments relied on in support of an action brought in a related case does not meet that requirement (judgment of 24 March 2011, Legris Industries v Commission, T‑376/06, not published, EU:T:2011:107, paragraph 32).

91 However, it should be noted that the Courts of the European Union were able to accept that pleas not expressly set out in the application could be regarded as validly raised by virtue of a reference to the pleas raised in another case in the event that the applicant had referred to its own written pleadings in another case (see judgment of 14 December 2005, Honeywell v Commission, T‑209/01, EU:T:2005:455, paragraphs 61 and 62 and the case-law cited). Those cases covered situations in which the parties were identical, as were the agents and lawyers representing them. On the other hand, the General Court held that to accept the admissibility of pleas in law not set out expressly in the application on the ground that they were raised by a third party in another case, to which reference is made in that application, would be to allow the mandatory requirements of Article 21 of the Statute of the Court of Justice of the European Union and of Article 44(1) of the Rules of Procedure of the General Court of 2 May 1991, to be circumvented (see, to that effect, judgments of 14 December 2005, Honeywell v Commission, T‑209/01, EU:T:2005:455, paragraphs 63 and 64; of 27 September 2012, Dura Vermeer Infra v Commission, T‑352/06, not published, EU:T:2012:483, paragraphs 25 and 26; of 27 September 2012, Koninklijke BAM Groep v Commission, T‑355/06, not published, EU:T:2012:486, paragraphs 26 and 27; and of 27 September 2012, Heijmans v Commission, T‑360/06, not published, EU:T:2012:490, paragraphs 25 and 26). Lastly, it must be recalled that each party is solely responsible for the content of the pleadings which it lodges, a rule laid down notably in Article 43(1) of the Rules of Procedure of 2 May 1991 (see, to that effect, judgments of 29 June 1995, ICI v Commission, T‑37/91, EU:T:1995:119, paragraph 46, and of 14 December 2005, Honeywell v Commission, T‑209/01, EU:T:2005:455, paragraph 66). In the present case, however, it is common ground that the applicants wish to rely on any possible annulment obtained by third parties and that, accordingly, neither the parties nor their representatives are identical.

93 Nevertheless, the Court of Justice introduced a qualification of that principle in the judgment of 22 January 2013, Commission v Tomkins (C‑286/11 P, EU:C:2013:29, paragraphs 43 to 49), in which it held that, to the extent that the liability of the parent company was derived exclusively from that of its subsidiary and where the parent company and its subsidiary had brought parallel actions having the same object, the General Court had not ruled ultra petita by taking into account the outcome of the action brought by the subsidiary in order to annul the contested decision in respect of the period in question as regards the parent company, even though the parent company had not challenged the existence of the infringement for the whole of the period challenged by its subsidiary. Nevertheless, the Court of Justice, in order to be able to apply such a solution to the fine imposed on a parent company whose liability is derived solely from that of its subsidiary, considered that there had to be special circumstances, inter alia the two companies had to have raised pleas ‘having the same object’ and the applicant parent company had to claim that such circumstances existed (see, to that effect, judgment of 11 July 2013, Team Relocation v Commission, C‑444/11 P, not published, EU:C:2013:464, paragraph 66).

94 However, the Court of Justice did not define that concept of ‘same object’ and has developed its position on the question whether special circumstances such as those at issue in the judgment of 22 January 2013, Commission v Tomkins (C‑286/11 P, EU:C:2013:29), involved a matter of public policy and had to be raised by a court of its own motion. Accordingly, it first applied that solution when two companies had contested the duration of the infringement and at least part of the contested period was identical (judgment of 22 January 2013, Commission v Tomkins, C‑286/11 P, EU:C:2013:29, paragraphs 43 and 44). The Court of Justice nevertheless also upheld a judgment of the General Court which adopted the same approach where the subsidiary had obtained a reduction in the amount of the fine imposed on it, on the basis of a failure properly to take into account its cooperation under the leniency programme, holding, in that case, that the parent company had sought, in the alternative, the reduction of the fine imposed on its subsidiary and, jointly and severally, on itself, and that ‘the purpose of [certain of its] pleas in law was, inter alia, to justify the grant of such a reduction’ (judgment of 26 September 2013, Alliance One International v Commission, C‑679/11 P, not published, EU:C:2013:606, paragraphs 103 to 107). Finally, in a judgment of 17 September 2015, Total v Commission (C‑597/13 P, EU:C:2015:613, paragraphs 31 to 42), the Court of Justice criticised a judgment of the General Court which failed to take into account, in the judgment relating to the parent company, a reduction in the amount of the fine granted to its subsidiary in another judgment delivered on the same day, on account of the method which the Commission, when calculating the amount of the fine, had used to define the multiplier corresponding to the duration of the infringement. However, the parent company had neither raised such a plea (it had, by contrast, contested the duration of the infringement) nor asked the General Court to be allowed to benefit from a reduction in the amount of the fine which had been imposed on it, if its subsidiary obtained such a reduction.

95 In the present case, Biogaran, a subsidiary of Servier, has also brought an action (case giving rise to the judgment delivered today, Biogaran v Commission (T‑677/14)) against Articles 1, 7 and 8 of the contested decision. Nevertheless, as the Commission pointed out at the hearing, the circumstances of the present case differ from those obtaining in the case which gave rise to the judgment of 22 January 2013, Commission v Tomkins (C‑286/11 P, EU:C:2013:29), and in the subsequent case-law, in particular in that the applicants’ liability is not solely derived from that of their subsidiary Biogaran (recitals 3006 to 3013 of the contested decision). Moreover, in any event, since the action brought by Biogaran in the case which gave rise to the judgment delivered today, Biogaran v Commission (T‑677/14), was dismissed by that judgment, the applicants’ claim to be allowed to benefit from any annulment in favour of Biogaran cannot succeed.

96 The applicants also claim that they should be allowed to benefit from any annulment obtained by another addressee of the contested decision ‘in order to avoid any difference in the treatment of situations which are legally and factually identical’. They argue that both the principle of equal treatment and a ‘general duty of consistency’ require application of that approach.

97 It must be recalled, in that regard, that the principle of equal treatment is a general principle of EU law, enshrined in Articles 20 and 21 of the Charter of Fundamental Rights of the European Union, which requires that comparable situations must not be treated differently and that different situations must not be treated in the same way unless such treatment is objectively justified (see judgment of 14 September 2010, Akzo Nobel Chemicals and Akcros Chemicals v Commission and Others, C‑550/07 P, EU:C:2010:512, paragraphs 54 and 55 and the case-law cited). A decision adopted in the sphere of competition law with respect to several undertakings, although drafted and published in the form of a single decision, must be seen as a set of individual decisions finding that each of the addressees is guilty of the infringement or infringements of which they are accused and imposing on them, where appropriate, a fine (see paragraph 92 above). Those undertakings are therefore, a priori, and without exception, in different situations. Consequently, the principle of equality of treatment does not allow the European Union judicature to derogate from the procedural rules governing the admissibility of the form of order sought by allowing an addressee of a competition law decision to benefit from annulment by another addressee of that decision on the basis of pleas raised only by the latter.

98 Moreover, the obligation on the General Court to state the reasons for its judgments cannot extend to imposing on it an obligation to justify the solution arrived at in one case in the light of that found in another, even if it concerned the same decision (see, to that effect, judgment of 11 July 2013, Team Relocation v Commission, C‑444/11 P, not published, EU:C:2013:464, paragraph 66).

99 It follows from the foregoing that the applicants’ third head of claim, seeking to benefit from any annulment obtained by other addressees of the contested decision on the basis of the pleas put forward by those other addressees, is inadmissible. Even if that head of claim were admissible, it must be rejected as unfounded, since the applicants cannot validly rely, for their benefit, as is apparent from paragraphs 92 to 98 above, on a solution adopted to the benefit of the other addressees of the contested decision.

2. Admissibility of certain annexes to the application

(a) Arguments of the parties

…

(b) Findings of the Court

102 The Commission argues that Annexes A 2 and A 3 to the application are inadmissible under the maxim iura novit curia. The annexes, which have a purely evidential and instrumental function, cannot, in fact, be used for the discussion or further development of a point of EU law, which falls within the sole competence of the Court. The Commission relies on the judgments of 5 July 2011, Edwin v OHIM (C‑263/09 P, EU:C:2011:452, paragraph 53), and of 20 March 2013, El Corte Inglés v OHIM — Chez Gerard (CLUB GOURMET) (T‑571/11, EU:T:2013:145, paragraph 35), according to which the maxim iura novit curia applies only to EU law and not to national law. It should be recalled that that maxim means that it is solely for the court, and not the parties, to determine the meaning of the law. The case-law has applied that maxim in order to emphasise that, although the Court must rule only on the heads of claim put forward by the parties, whose role it is to define the framework of the dispute, the Court cannot confine itself to the arguments put forward by the parties in support of their claims, or it might be forced to base its decision on erroneous legal considerations (orders of 27 September 2004, UER v M6 and Others, C‑470/02 P, not published, EU:C:2004:565, paragraph 69, and of 13 June 2006, Mancini v Commission, C‑172/05 P, EU:C:2006:393, paragraph 41; judgments of 21 September 2010, Sweden and Others v API and Commission, C‑514/07 P, C‑528/07 P and C‑532/07 P, EU:C:2010:541, paragraph 65, and of 8 July 2010, Commission v Putterie-De-Beukelaer, T‑160/08 P, EU:T:2010:294, paragraph 65). Similarly, according to that maxim, determining the meaning of the law does not fall within the scope of application of a principle which allows the parties a free hand to determine the scope of the case and the EU Court is therefore not obliged to inform the parties of the interpretation it intends to give in order to enable them to adopt a position on that subject (see judgment of 5 October 2009, Commission v Roodhuijzen, T‑58/08 P, EU:T:2009:385, paragraph 36 and the case-law cited), without prejudice to compliance by the EU Court with the obligation to allow the parties to be apprised of, and to be able to debate and be heard on, the matters of fact and of law which will determine the outcome of the proceedings (judgment of 2 December 2009, Commission v Ireland and Others, C‑89/08 P, EU:C:2009:742, paragraph 56). That maxim cannot, however, mean that annexes to the application relating to the interpretation of EU law are inadmissible.

103 Moreover, the objection of inadmissibility raised by the Commission seems to be motivated by the fact that the two annexes at issue contain opinions given for the benefit of the applicants by Sir Jacobs and Ms Macken, in their capacity as lawyers, but whose status as former Members of the Court of Justice of the European Union is well known, and that the applicants are relying on that latter status. When the Commission was asked at the hearing whether, through its challenge to the admissibility of the legal opinions thus given, it intended to rely on the failure of those former members of the Court of Justice to fulfil their obligations under the Code of Conduct of the Members of the Court of Justice of the European Union (OJ 2007 C 223, p. 1), in particular under Article 6 of that Code of Conduct, concerning the undertakings of Members after ceasing to hold office, the Commission replied that it did not intend to do so. The Court took formal notice of this in the minutes of the hearing.

104 In the alternative, the Commission argues that, according to the case-law, a legal opinion annexed to an application is admissible only to support and supplement the essential elements which must be included in the application, provided that the relevant parts of the documents annexed are identified and referenced in the application. In the present case, with respect to certain pleas, the texts and arguments in Annexes A 2 and A 3 to the application contain most, if not all, of the applicants’ arguments.

105 It must be borne in mind, in that regard, that, according to the case-law set out in paragraph 90 above, under Article 21 of the Statute of the Court of Justice of the European Union and Article 44(1)(c) of the Rules of Procedure of the General Court of 2 May 1991, applicable at the time the action was brought, each application is required to state the subject matter of the proceedings and a summary of the pleas in law on which the application is based, and it is necessary, in order for an action to be admissible, that the basic legal and factual particulars relied on be indicated, at least in summary form, coherently and intelligibly in the text of the application itself.

106 Whilst the body of the application may be supported and supplemented on specific points by references to extracts from documents annexed thereto, a general reference to other documents, even those annexed to the application, cannot make up for the absence of the essential arguments in law which, in accordance with the abovementioned provisions, must appear in the application. Furthermore, it is not for the Court to seek and identify in the annexes the pleas and arguments on which it may consider the action to be based, since the annexes have a purely evidential and instrumental function (see judgment of 17 September 2007, Microsoft v Commission, T‑201/04, EU:T:2007:289, paragraph 94 and the case-law cited). Consequently, in the present case, the Court can take into consideration Annexes A 2 and A 3 to the application only in so far as they support or supplement pleas or arguments expressly set out by the applicants in the body of the application and in so far as it is possible for the Court to determine precisely what are the matters they contain that support or supplement those pleas or arguments (judgment of 17 September 2007, Microsoft v Commission, T‑201/04, EU:T:2007:289, paragraph 99).

107 As regards, more particularly, Annex A 2 to the application, it must be held, contrary to what the Commission submits, that the essence of the applicants’ arguments is indeed contained in the body of the application and that the elements set out in that annex merely support and supplement, on specific points, the pleas and arguments contained in the body of the application, which it is easy for the Court to identify.

108 For example, the applicants stated, in paragraph 103 of the application, that the contested decision acknowledged that patent dispute settlements between competitors had in general a legitimate objective and that certain Member States encouraged the seeking of settlements. In paragraph 24 of Annex A 2 to the application, to which paragraph 103 of the application refers, it is likewise stated that there is a strong public interest in the settlement of disputes, that many national legal systems encourage, or even require, the seeking of a settlement as a pre-condition for bringing court proceedings, and that the contested decision, in that it constitutes a restriction on the right to reach a settlement, runs counter to that policy and results in the imposition of unnecessary costs on the parties and the courts. Since the applicants therefore put forward, in paragraph 24 of Annex A 2 to the application, arguments which merely support and supplement the elements expressly relied on in the body of the application, those arguments are admissible.

109 With regard to paragraphs 29 and 818 of the application, in connection with which the Commission claims that the applicants merely referred to Sir Jacobs’ opinion, it should be noted that the applicants set out in detail in paragraphs 816 to 822 of the application the reasons why the Commission could not, in their view, impose a fine on them on account of the unprecedented and unforeseeable nature of the position adopted by the Commission and that paragraphs 70 and 76 of Annex A 2 to the application do not contain new arguments or discussions in that regard.

110 As regards paragraph 147 of the application, in which the applicants state that the approach which they propose to adopt in order to identify settlement agreements contrary to the provisions of Article 101 TFEU is consistent with the position adopted by the judgment of the Supreme Court of the United States of 17 June 2013, Federal Trade Commission v. Actavis (570 U. S. (2013), ‘the Actavis judgment’), it must be observed that that paragraph refers, by means of footnote 153, to paragraphs 32 and 33 of Annex A 2. However, in paragraph 32 of that annex, the applicants merely support that argument and, in paragraph 33 of that annex, they confine themselves to arguing that the scope of the Actavis judgment cannot be limited to a national context unconnected with EU law and that the view of the Supreme Court of the United States deserves particular respect, given its reputation and experience in competition law. Consequently, those arguments are admissible.

111 As regards Annex A 3 to the application, it must be held, as the Commission argues, that, although, in paragraph 11 of the application, the applicants maintain that the Commission’s attitude is not neutral with regard to intellectual property rights, they nevertheless merely refer to paragraphs 8, 15, 31, 34 and 41 of Annex A 3 to the application, in which Ms Macken puts forward arguments relating to (i) the need to draw a distinction between the various areas of intellectual property, (ii) the fact that the granting of a monopoly over patents is the quid pro quo for the disclosure of the invention to the public, (iii) the erroneous use of the concept of ‘market exclusivity’ by the Commission in the contested decision and (iv) a misinterpretation by the Commission of the EPC. Consequently, those arguments are not admissible, with the exception of that relating to the fact that the granting of a monopoly over patents is the quid pro quo for the disclosure of the invention to the public. In paragraph 67 of the application, the applicants referred to the fact that the Commission ‘completely disregarded that essential aspect of patents, namely their publication for the purpose of disseminating inventions’.

112 Similarly, in paragraph 68 of the application, the applicants claim that the Commission cited in a biased way the statements of the Court of Appeal (England & Wales) (Civil division) in the judgment of 9 May 2008 dismissing Servier’s appeal against the judgment of the High Court of Justice (England & Wales), Chancery Division (Patents Court), and criticise the Commission for not taking into account the report of Professor S. annexed to their response to the statement of objections in that regard. They also refer to paragraphs 113 to 117 of Annex A 3 to the application. In those paragraphs, Ms Macken does not merely supplement or expand on those arguments, but puts forward arguments relating to the Commission’s alleged misuse of evidence which allowed it to conclude that the 947 patent was invalid. She thus sets out arguments seeking to call into question the Commission’s interpretation of the statement by the applicant’s Patent Director referred to in recitals 127 and 185 of the contested decision, of the statement by Krka’s legal adviser referred to in recital 883 of that decision and of the statement by Krka’s sales manager for western Europe referred to in paragraph 895 of that decision. Consequently, those arguments are not admissible.

113 With regard to paragraph 76 of the application, it is also necessary to hold, as the Commission points out, that, although the applicants stated in footnote 79 of the application that the sending of letters of formal notice was lawful, they merely referred to paragraphs 58 to 67 of Annex A 3 to the application to explain the grounds supporting a finding that the sending of such letters is lawful. The arguments put forward in Annex A 3 to the application on that point are therefore not admissible.

114 In paragraph 103 of the application, the applicants merely pointed out that the contested decision acknowledged that patent dispute settlements between competitors had in general a legitimate objective and that certain Member States encouraged the seeking of settlements. However, paragraphs 50 to 54 of Annex A 3 to the application, to which paragraph 103 of the application refers (footnote 113), criticise the Commission for not having adequately assessed the settlement practices used worldwide, which are set out in detail.

115 With regard to paragraph 46 of the reply, the applicants argue that the idea that it would be preferable for any litigation to result in a judgment is ‘contrary to current thinking in relation to judicial proceedings’, referring to paragraph 112 of Annex A 3 to the application, which states that the Commission’s approach is contrary to Directive 2008/52/EC of the European Parliament and of the Council of 21 May 2008 on certain aspects of mediation in civil and commercial matters (OJ 2008 L 136, p. 3). Since those arguments do not merely support or supplement the elements expressly relied upon in the body of the application, they are inadmissible.

116 Finally, in paragraph 262 of the application, the applicants stated that it was of primary importance for Teva to be among the first generic undertakings to enter the market in the United Kingdom, referring to paragraph 90 of Annex A 3 to the application. Contrary to what the Commission maintains, in that paragraph of Annex A 3 to the application, the applicants have merely supported and supplemented that assertion by setting out the reasons why a generic undertaking has an interest in entering a market only if it is among the first entrants. Accordingly, the arguments put forward in Annex A 3 to the application on that point are admissible.

B. Substance

1. Infringement of the principle of impartiality and of the right to sound administration

(a) Arguments of the parties

…

(b) Findings of the Court

119 As a preliminary point it should be noted that the guarantees afforded by the EU legal order in administrative proceedings include, in particular, the principle of sound administration, affirmed in Article 41 of the Charter of Fundamental Rights, which entails the duty of the competent institution to examine carefully and impartially all the relevant aspects of the individual case (judgments of 30 September 2003, Atlantic Container Line and Others v Commission, T‑191/98 and T‑212/98 to T‑214/98, EU:T:2003:245, paragraph 404, and of 27 September 2012, Shell Petroleum and Others v Commission, T‑343/06, EU:T:2012:478, paragraph 170). That requirement of impartiality encompasses, on the one hand, subjective impartiality, in so far as no member of the institution concerned who is responsible for the matter may show bias or personal prejudice, and, on the other hand, objective impartiality, in so far as there must be sufficient guarantees to exclude any legitimate doubt as to bias on the part of the institution concerned (see judgment of 11 July 2013, Ziegler v Commission, C‑439/11 P, EU:C:2013:513, paragraph 155 and the case-law cited). It is also important to note that the Commission may not be classified as a ‘tribunal’ within the meaning of Article 6 of the Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘the ECHR’), and it is thus Article 41 of the Charter of Fundamental Rights, not Article 47 thereof, which governs the administrative procedure relating to restrictive practices before the Commission (see judgment of 11 July 2013, Ziegler v Commission, C‑439/11 P, EU:C:2013:513, paragraph 154 and the case-law cited).

120 The applicants rely on two judgments of the European Court of Human Rights (‘the ECtHR’). In the first place, the applicants rely on the judgment of the ECtHR of 25 March 2008, Vitan v. Romania (CE:ECHR:2008:0325JUD004208402), relating to the presumption of innocence, enshrined in Article 6(2) of the ECHR, in which the ECtHR found a breach of that provision, because the prosecutor in charge of the criminal investigation relating to the applicant had stated at a press conference that the applicant was guilty of trading in influence, although the applicant’s guilt had not yet been lawfully established, and the prosecutor had not ‘qualified his remarks or taken care to place them in the context of the proceedings pending against the applicant’ (paragraphs 70 and 71). In that respect, it is important to recall that, according to the case-law of the ECtHR, the principle of the presumption of innocence may be infringed not only by a court or tribunal but also by other public authorities, that it is appropriate to emphasise the importance of the choice of words used by State officials in the statements they make before a person has been tried and convicted of an offence and that what matters for the purposes of the application of Article 6(2) of the ECHR is the actual meaning of the statements in question and not their literal form (see ECtHR, 15 March 2011, Begu v. Romania, CE:ECHR:2011:0315JUD002044802, paragraph 126 and the case-law cited). The ECtHR nevertheless acknowledges that Article 6(2) of the ECHR cannot prevent, in the light of Article 10 thereof, which protects freedom of expression, the authorities from informing the public about criminal investigations in progress, but it requires that they do so with all the discretion and circumspection necessary if the presumption of innocence is to be respected (ECtHR, 10 February 1995, Allenet de Ribemont v. France, CE:ECHR:1995:0210JUD001517589, paragraph 38).

121 In the second place, the applicants rely on the judgment of the ECtHR of 16 September 1999, Buscemi v. Italy (CE:ECHR:1999:0916JUD002956995), in which the ECtHR found that there had been a breach of Article 6(1) of the ECHR and of the right of every person to a fair hearing by an independent and impartial tribunal, where the President of the court publicly used expressions which implied that he had already formed an unfavourable view of the applicant’s case before presiding over the court that had to decide it (paragraphs 68 and 69). In that judgment, the ECtHR also recalled that the judicial authorities were required to exercise maximum discretion with regard to the cases with which they deal in order to preserve their image as impartial judges and that that discretion should dissuade them from making use of the press, even when provoked (paragraph 67). It should be recalled, however, that in the case-law of the EU Courts the Commission cannot be described as a ‘court’ within the meaning of Article 6 of the ECHR (see paragraph 119 above).

122 The applicants rely, moreover, on the judgment of 8 July 2008, Franchet and Byk v Commission (T‑48/05, EU:T:2008:257, paragraphs 210 to 219), in which the General Court found, within the context of an action for compensation, an infringement by the European Anti-Fraud Office (OLAF) of the principles of the presumption of innocence and sound administration and of its obligation of confidentiality, in that it provoked the disclosure in the press of sensitive elements of ongoing investigations and stated that the applicants were likely to have committed a ‘“vast enterprise of looting” of European Union funds’ (paragraph 216).

123 Moreover, the Court has already provided clarification concerning the duty of impartiality and the principle of sound administration which the Commission is required to observe in competition law cases. Accordingly, in the judgment of 20 March 2002, ABB Asea Brown Boveri v Commission (T‑31/99, EU:T:2002:77, paragraphs 99 to 107), the Court rejected a plea alleging infringement of the principle of sound administration in a case in which the applicant had, at its hearing before the Commission, been subject to a derogatory remark concerning its reputation and to a series of tendentious questions about facts which it no longer disputed, on the part of a Commission official dealing with the case which led to the contested decision, and in which the same official had, at a conference on issues of competition law held before the adoption of the Commission’s decision, expressed his views using a quotation casting discredit on the applicant’s activities. Indeed, while acknowledging that those remarks showed regrettable behaviour and language on the part of a member of the team responsible for dealing with the case and recalling that the Commission’s Director-General of the Directorate-General for Competition had apologised to the applicant following the remark made at the conference, the Court held that those remarks were not of such a kind as to cast doubt on the degree of care and impartiality with which the Commission conducted its investigation into the infringement at issue and that the regrettable conduct on the part of a member of the team dealing with a case did not in itself vitiate the legality of the decision adopted by the College of Commissioners.

124 As regards the combining by the Commission of the functions of investigation and punishment of infringements of the competition rules, the Court of Justice has ruled that it was not in itself contrary to Article 6 of the ECHR as interpreted by the ECtHR (see, to that effect, judgment of 18 July 2013, Schindler Holding and Others v Commission, C‑501/11 P, EU:C:2013:522, paragraphs 33 and 34) and the General Court has held that it did not constitute an infringement of the requirement of impartiality (see, to that effect, judgment of 27 June 2012, Bolloré v Commission, T‑372/10, EU:T:2012:325, paragraphs 65 to 67). The absence of separation between the functions of investigation and punishment within the Commission does, however, entail a particular responsibility on the part of the members of that institution, in particular on the part of the Commissioner responsible for competition, to avoid any bias in the investigation and conduct of infringement proceedings, since they have the power to punish the undertakings concerned at the end of those proceedings.

125 The Court has, moreover, held that the Commission’s assertion that it is determined that the members of anticompetitive cartels should not escape, on procedural grounds, the penalties applicable under EU law is not an infringement of the principle of impartiality but merely the assertion of a clear intention, wholly consistent with the task entrusted to the Commission, of making good, on a case-by-case basis, the procedural irregularities found, in order not to undermine the effectiveness of EU competition law (judgment of 27 June 2012, Bolloré v Commission, T‑372/10, EU:T:2012:325, paragraphs 73 and 74).

126 It should also be borne in mind that the EU judicature — in order to reject a plea alleging infringement of the right to a fair trial or of the principle of sound administration, based on the public positions adopted by the Commission or one of its representatives during the administrative procedure — has already relied on the ground that there was nothing in the Court’s file to support the presumption that the contested decision would not have been taken, or would have been drawn up in a different way, if the public statements which are the subject matter of this submission had not been made (see, to that effect, judgments of 16 December 1975, Suiker Unie and Others v Commission, 40/73 to 48/73, 50/73, 54/73 to 56/73, 111/73, 113/73 and 114/73, EU:C:1975:174, paragraph 91, and of7 July 1994, Dunlop Slazenger v Commission, T‑43/92, EU:T:1994:79, paragraph 29). According to the case-law, it is thus for the applicant to produce at least some indicia to support such a conclusion (judgment of 15 March 2006, BASF v Commission, T‑15/02, EU:T:2006:74, paragraph 606).

127 It is also important to recall that the functioning of the Commission is governed by the principle of collegiate responsibility laid down in Article 250 TFEU, which is based on the equal participation of the Commissioners in the adoption of decisions, from which it followed in particular that decisions should be the subject of collective deliberation and that all the members of the College of Commissioners should bear collective responsibility at political level for all decisions adopted. This is particularly so in the case of acts which are expressly described as decisions which the Commission finds necessary to adopt with regard to undertakings for the purpose of ensuring observance of the competition rules and by which it finds an infringement of those rules, issues directions to those undertakings and imposes pecuniary sanctions upon them. The operative part of, and the statement of reasons for, a decision constitute an indivisible whole and it is therefore for the College of Commissioners alone to adopt both the operative part and the statement of reasons, in accordance with the principle of collegiate responsibility (judgment of 27 September 2012, Heijmans Infrastructuur v Commission, T‑359/06, not published, EU:T:2012:489, paragraphs 126 and 127). The Court has also held, in matters relating to State aid, that the expression of an opinion by the Commissioner responsible for competition matters on a procedure in progress is, in so far as it is strictly personal and without prejudice, attributable to that Commissioner alone and does not predetermine the position that the College of Members of the Commission will adopt at the end of the procedure (judgment of 8 July 1999, Vlaamse Televisie Maatschappij v Commission, T‑266/97, EU:T:1999:144, paragraphs 49 and 54). Moreover, it cannot be assumed that the Commissioners were constrained in their freedom of assessment by a misplaced feeling of solidarity towards their colleague with responsibility for competition matters (judgment of 15 March 2006, BASF v Commission, T‑15/02, EU:T:2006:74, paragraph 610).

128 As regards objective impartiality, which refers to the fact that the institution must provide sufficient guarantees to exclude any legitimate doubt, it should be pointed out that the Commission, as it stated at the hearing in reply to a question from the Court, has adopted several internal documents requiring it to comply with certain rules when communicating publicly. In particular, the Code of Conduct for Commissioners (C(2011) 2904), adopted in 2011, provides in Article 1.7 thereof that, in accordance with the principle of collegiality, Members of the Commission are to refrain from making any comment that would call into question a decision taken by the Commission and are also to refrain from disclosing what is said at meetings of the Commission. Moreover, the Annex to Decision 2000/633/EC, ECSC, Euratom of 17 October 2000 amending its Rules of Procedure (OJ 2000 L 267, p. 63), entitled ‘Code of good administrative behaviour for Staff of the European Commission in their relations with the public’, states in its provisions that ‘quality service calls for the Commission and its staff to be courteous, objective and impartial’, and in paragraph 2 thereof, concerning objectivity and impartiality, that ‘staff shall always act objectively and impartially, in the [European Union] interest and for the public good’ and that ‘they shall act independently within the framework of the policy fixed by the Commission and their conduct shall never be guided by personal or national interest or political pressure’. Similarly, the Code of Ethics and Integrity of DG Competition, adopted on 28 June 2010, recommends that its staff, with regard to freedom of expression, avoid any discussion of a case concerning which the Commission has not adopted an official position and, with regard to contacts with the media, avoid talking about a case which is still the subject of investigation and in respect of which the Commission has not adopted an official position.

129 The applicants claim that the Ombudsman has already established an instance of maladministration concerning the Commissioner responsible for competition who was in office when the contested decision was adopted, in so far as he had, as in the present case, made public statements suggesting that he had already reached a conclusion before the end of the investigation.

130 In that regard, it should be recalled that a finding by the Ombudsman of an ‘act of maladministration’ is not binding on the Courts of the European Union and can constitute nothing more than an indication of infringement, by the institution concerned, of the principle of sound administration. Proceedings before the Ombudsman, who does not have the power to make binding decisions, are for EU citizens an extrajudicial alternative remedy to an action before those Courts, which meets specific criteria and does not necessarily have the same objective as legal proceedings (judgment of 25 October 2007, Komninou and Others v Commission, C‑167/06 P, not published, EU:C:2007:633, paragraph 44). A fortiori, interpretations of EU law by the Ombudsman are incapable of binding the Courts of the European Union.

131 In the present case, as regards subjective impartiality, which relates to the fact that a member of the institution concerned who is responsible for the case must not show bias or personal prejudice, the applicants criticise each of the consecutive Commissioners for Competition, Ms N. Kroes and Mr J. Almunia, for having made, on three occasions, public comments on the outcome of the investigation relating to the applicants during the administrative procedure. As the applicants pointed out at the hearing, those two Commissioners were still in office within the Commission when the contested decision was adopted, were involved in adopting it and were directly responsible for the investigation of the case at various times. Moreover, the contested decision is signed by Mr Almunia.

132 In the first place, it is apparent from the file that, at the press conference on the presentation of the conclusions of the pharmaceutical sector inquiry report, Ms Kroes stated that ‘unfortunately, the report confirm[ed] that there [we]re competition problems in the pharma sector’, that ‘company practices [we]re a significant factor behind them’ and that, ‘in particular, the report conclude[d] that makers of original medicines [we]re actively trying to delay the entry of generic medicines onto their markets’ (speech published on the DG Competition website). According to the applicants, Ms Kroes further stated that ‘overall it is indeed a conclusion that there [wa]s something rotten in the state’ (extract from the website of the EU Observer online newspaper). The Commission submits in the rejoinder that those remarks were merely reported by a journalist and that the article confirms that the term ‘rotten’ related to the sector inquiry and not to the applicants. At the same press conference, the same Commissioner for Competition referred, in a separate part entitled ‘Competition cases and scrutiny’, to the opening of proceedings against the applicants and certain generic undertakings, stating that ‘it concern[ed] suspected breaches of the [FEU] Treaty’s rules on both restrictive business practices (Article [101 TFEU]) and abuse of a dominant market position (Article [102 TFEU])’, that ‘the case w[ould] look at the agreements between Servier and a number of generic companies’ and that ‘these agreements [had] affected the entry of generic competitors against perindopril, a leading drug that combat[ed] heart-disease and high blood pressure’. The Commissioner for Competition therefore clearly distinguished the results of the sector inquiry from the decision to initiate proceedings against the applicants. As regards the latter, the Commissioner for Competition was careful to point out that potential infringements of the competition rules were at issue. The mere circumstance that she referred, in the following sentence, to the fact that the agreements in question had affected the entry of generic medicines into the market cannot, in itself, imply that she considered that an infringement of the competition rules had taken place, in the light of the context referred to in the preceding sentence. At that press conference, the Commissioner for Competition therefore merely informed the public about investigations in progress, with the discretion and circumspection necessary if the presumption of innocence is to be respected.

133 In the second place, on 8 October 2012, during a speech to the European Parliament presenting the Commission’s competition policy work programme for 2013-2014, Mr Almunia referred, in particular, to the procedure relating to the agreements at issue, stating that, ‘in the pharmaceutical industry, … and Servier [had] received [the Commission’s] objections before the summer’, that he was ‘concerned that these companies misused their patents to keep markets closed to cheap generic medicines’ and that he ‘hope[d] that the decisions [which would be] adopt[ed] — hopefully in 2013 — [would] change current practices by some players in the industry that le[ft] a lot to be desired’ (speech published on the DG Competition website). By stating that the Commission had sent a statement of objections to the applicants and to other undertakings in the present case and in another case and that decisions would be adopted in 2013, the Commissioner did not fail to fulfil his obligation of impartiality, however, and merely informed Parliament about investigations in progress, with the discretion and circumspection necessary if the presumption of innocence is to be respected. Indeed, it is necessary to recall the preliminary nature of the statement of objections, the function of that document, as defined by the European Union regulations, being to give undertakings all the information necessary to enable them properly to defend themselves, before the Commission adopts a final decision (see judgment of 27 September 2012, Koninklijke Wegenbouw Stevin v Commission, T‑357/06, EU:T:2012:488, paragraph 43 and the case-law cited). Although the Commission, under Article 27(1) of Regulation No 1/2003, must thus base its final decision only on objections on which the parties have been able to comment, it is not required to reproduce all the evidence set out in the statement of objections, particularly if that evidence appears insufficient. It is therefore inherent in the nature of the statement of objections that it is provisional and subject to amendments to be made by the Commission in its further assessment on the basis of the observations submitted to it by the parties and subsequent findings of fact (judgment of 10 July 2008, Bertelsmann and Sony Corporation of America v Impala, C‑413/06 P, EU:C:2008:392, paragraph 63). Moreover, following communication of the statement of objections, by which the Commission considers on first analysis that an infringement has been committed, the duty of circumspection of the Commissioner for Competition need not necessarily be so broad, since that Commissioner may, in public statements, set out with all due caution, as regards a provisional assessment, the allegations made against an undertaking at that stage of the procedure.

134 In the third place and finally, it is apparent from the file that, on 12 April 2013, Mr Almunia stated, in a speech to the American Bar Association in Washington which was transcribed in the press, that ‘the Commission … [would] decide in the coming months on the legality of agreements between pharmaceutical undertakings seeking to delay the entry into the market of cheaper generic medicines’ and that ‘the results of the sector inquiry will be reflected in decisions in the … and Servier cases’ (extract from the MLex website). It should be emphasised that that article only indirectly reports the remarks of the Commissioner. Moreover, even if the Commissioner for Competition actually made those remarks, they can be interpreted only as meaning that there was a possibility that a decision might be adopted in the case at issue (see, to that effect and by analogy, judgment of 8 July 1999, Vlaamse Televisie Maatschappij v Commission, T‑266/97, EU:T:1999:144, paragraph 53). Therefore, the Commissioner for Competition merely informed the public about investigations in progress, with the discretion and circumspection necessary if the presumption of innocence is to be respected. In any event, it must be borne in mind that those remarks were merely the expression of the Commissioner for Competition’s opinion on an ongoing procedure, and were attributable to that Commissioner alone and did not predetermine the position that the College of Members of the Commission adopted at the end of the procedure (see paragraph 127 above).

135 Consequently, there is no need to examine the applicants’ argument that the contested decision would have been different in the absence of those statements by the Commissioners.

136 In support of this plea, the applicants also criticise the Commissioner for Competition and his cabinet for not having been present during most of the hearing. However, the fact, emphasised at the hearing by the applicants, that Mr Almunia did not attend their hearing before the Commission and was represented by a member of his cabinet is not such as to establish that the decision to impose a penalty had already been adopted, in principle, even before that hearing. Moreover, there is no provision requiring the participation of the Commissioner or a member of his cabinet at the hearing. The EU Courts take the view that the principle of proper administration cannot transform into an obligation that which the legislature did not view as being one (see, to that effect, judgment of 27 September 2012, Koninklijke Wegenbouw Stevin v Commission, T‑357/06, EU:T:2012:488, paragraph 242).

137 The applicants also complain that the Commission failed to comply with the applicable rules and standards of evidence, referring to several recitals of the contested decision which they contest in other pleas in their application (distortion of the facts, error in the legal criterion applicable to the classification of an infringement by object, an unreasonable interpretation of the concept of potential competition, etc.). In the reply, they argue that those examples are intended to establish bias vitiating the investigation. As claimed by the Commission, that line of argument of the applicants is, however, indissociable from the question whether the findings of fact made in the contested decision are duly supported by the evidence which the institution has produced and whether the Commission committed errors of law in its analysis (see, to that effect, judgment of 24 October 1991, Atochem v Commission, T‑3/89, EU:T:1991:58, paragraph 39). Consequently, those arguments will be examined subsequently, in the context of the substantive pleas. In any event, it must be pointed out that those arguments are based on mere assertions and are not such as to show that the Commission did in fact pre-judge the outcome of the administrative procedure or lacked objectivity in its investigation (see, to that effect, judgment of 6 July 2000, Volkswagen v Commission, T‑62/98, EU:T:2000:180, paragraph 272).

138 Lastly, the applicants argue that the absence of a re-examination of the case by an internal panel within DG Competition demonstrates the partiality of the contested decision and justifies its annulment on the grounds of infringement of the principle of the presumption of innocence and of Article 41 of the Charter of Fundamental Rights. However, it is important to note that no provision of a regulation or internal rule of the Commission requires that the Commission organise a re-examination of every case by an internal panel and to recall that the principle of proper administration cannot transform into an obligation that which the legislature did not view as being one (see paragraph 136 above). A peer review system was indeed set up within DG Competition in 2004. Nevertheless, it is apparent from a document published in September 2011 by the Commission, entitled ‘Procedure for the application of Articles 101 and 102 TFEU: key players and the balance of power’, that the Director-General of DG Competition determines, in agreement with the Commissioner for Competition, the cases in which that internal panel is organised, that the decision to form such a panel and its composition are not made public and that the peer review of a case under no circumstances involves the parties to the proceedings or any other third party. The organisation of such a re-examination by DG Competition is therefore not required in all cases, with the result that the Commission cannot be criticised for not having organised such a re-examination in the present case.

139 The plea must therefore be rejected.

2. The lack of effective consultation of the Advisory Committee on Restrictive Practices and Dominant Positions

(a) Arguments of the parties

…

(b) Findings of the Court

142 Article 14(1) of Regulation No 1/2003, which is contained in Chapter IV on cooperation between the Commission and the competition authorities and courts of the Member States, provides that ‘the Commission shall consult an Advisory Committee on Restrictive Practices and Dominant Positions prior to the taking of any decision under Articles 7, 8, 9, 10, 23, Article 24(2) and Article 29(1)’ of that regulation. Article 14(2) of Regulation No 1/2003 provides that ‘for the discussion of individual cases, the Advisory Committee shall be composed of representatives of the competition authorities of the Member States’. Article 14(3) of Regulation No 1/2003 stipulates that the Advisory Committee is to deliver a written opinion on the Commission’s preliminary draft decision and Article 14(5) of that regulation provides that ‘the Commission shall take the utmost account of the opinion delivered by the Advisory Committee’ and ‘shall inform the Committee of the manner in which its opinion has been taken into account’. Furthermore, ‘at the request of one or several members, the positions stated in the opinion shall be reasoned’ (Article 14(3) of Regulation No 1/2003). Paragraph 58 of the Commission Notice on cooperation within the Network of Competition Authorities (OJ 2004 C 101, p. 43, ‘the Notice on cooperation within the Network of Competition Authorities’) provides that ‘the Advisory Committee is the forum where experts from the various competition authorities discuss individual cases and general issues of [EU] competition law’.

143 As regards procedure, Article 14(3) of Regulation No 1/2003 provides that the consultation of the Advisory Committee ‘may take place at a meeting convened and chaired by the Commission, held not earlier than 14 days after dispatch of the notice convening it, together with a summary of the case, an indication of the most important documents and a preliminary draft decision’. Nevertheless, ‘where the Commission dispatches a notice convening the meeting which gives a shorter period of notice than those specified above, the meeting may take place on the proposed date in the absence of an objection by any Member State’. Paragraph 66 of the Notice on cooperation within the Network of Competition Authorities states that ‘the Council Regulation allows for the possibility of the Member States agreeing upon a shorter period of time between the sending of the invitation and the meeting’. Article 14(3) of Regulation No 1/2003 provides, moreover, that the Advisory Committee ‘may deliver an opinion even if some members are absent and are not represented’. Article 14(4) of Regulation No 1/2003 provides, lastly, that ‘consultation may also take place by written procedure’, but that ‘if any Member State so requests, the Commission shall convene a meeting’. According to that provision, ‘in case of written procedure, the Commission shall determine a time limit of not less than 14 days within which the Member States are to put forward their observations for circulation to all other Member States’.

144 The document entitled ‘Working Arrangements for the Antitrust Advisory Committee’ of 19 December 2008, adduced by the Commission on 6 November 2015 in response to a measure of organisation of procedure, sets out the various steps leading up to the consultation of the Advisory Committee and, in particular, those allowing the national competition authorities to assess the case as the investigation progresses.

145 In the first place, it should be noted, in that respect, that, under Article 11(2) of Regulation No 1/2003, ‘the Commission shall transmit to the competition authorities of the Member States copies of the most important documents it has collected with a view to applying Articles 7, 8, 9, 10 and Article 29(1)’ of that regulation and, ‘at the request of the competition authority of a Member State, the Commission shall provide it with a copy of other existing documents necessary for the assessment of the case’. Article 11(6) of Regulation No 1/2003 provides, in addition, that ‘the initiation by the Commission of proceedings for the adoption of a decision under Chapter III shall relieve the competition authorities of the Member States of their competence to apply Articles [101 and 102 TFEU]’ and that, ‘if a competition authority of a Member State is already acting on a case, the Commission shall only initiate proceedings after consulting with that national competition authority’. Under those provisions, the Commission is to immediately deliver to the national competition authorities, after their notification to the undertaking concerned or their reception, the initial decision initiating the proceedings, the statement of objections addressed to that undertaking, the latter’s response to that statement of objections and the other most important documents relating to the case (see paragraphs 6 and 7 of the Working Arrangements for the Antitrust Advisory Committee).

146 In the second place, the Working Arrangements for the Antitrust Advisory Committee provide, in paragraphs 33 to 36, that, for each case in which the Commission addresses a statement of objections to an undertaking, the Commission must, not later than 45 days following the notification of the statement of objections to the parties concerned, appoint one of the national competition authorities as the rapporteur in the case (‘the NCA rapporteur’), on a rotating basis that corresponds to the rotating presidencies of the Council of the European Union, unless it is necessary to choose another national competition authority in the interests of objectivity, in which case the Commission may, subject to the agreement of the first national competition authority, choose the next authority on that list of rotating presidencies (paragraphs 28, 33 and 34). The NCA rapporteur, who is responsible for helping the other national competition authorities to understand the case and for informing them of the significant procedural steps in the administrative proceedings, works to that end in close cooperation with the Commission (paragraphs 40 and 42). The Working Arrangements for the Antitrust Advisory Committee also recommend that the NCA rapporteur should circulate a list of key questions in the case not later than five days prior to the Advisory Committee meeting (paragraph 44(i)) and should present the case and its issues at the beginning of the Advisory Committee meeting (paragraph 44(ii)).

147 In the third place, according to Article 11(1) of Commission Regulation (EC) No 773/2004 of 7 April 2004 relating to the conduct of proceedings by the Commission pursuant to Articles [101 and 102 TFEU] (OJ 2004 L 123, p. 18), ‘the Commission shall give the parties to whom it has addressed a statement of objections the opportunity to be heard before consulting the Advisory Committee referred to in Article 14(1) of Regulation … No 1/2003’. Article 14(3) of Regulation No 773/2004 provides, moreover, that ‘the Commission shall invite the competit