Judgments nº T-679/14 of Tribunal General de la Unión Europea, December 12, 2018

• Resolution Date: December 12, 2018
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-679/14

(Competition - Agreements, decisions and concerted practices - Perindopril market, medicinal product intended for the treatment of cardiovascular diseases, in its originator and generic versions - Decision finding an infringement of Article 101 TFEU - Principle of impartiality - Consultation of the Advisory Committee on Restrictive Practices and Dominant Positions - Patent dispute settlement and exclusive purchasing agreement - Potential competition - Restriction of competition by object - Balance between competition law and patent law - Conditions for exemption under Article 101(3) TFEU - Fines)

In Case T-679/14

Teva UK Ltd, established in West Yorkshire (United Kingdom),

Teva Pharmaceuticals Europe BV, established in Utrecht (Netherlands),

Teva Pharmaceutical Industries Ltd, established in Jerusalem (Israel),

represented by D Tayar and A. Richard, lawyers,

applicants,

supported by

European Generic medicines Association AISBL (EGA), established in Brussels (Belgium), represented by S.-P. Brankin, Solicitor, and E. Wijckmans, lawyer,

intervener

v

European Commission, represented initially by F. Castilla Contreras, T. Vecchi and B. Mongin, and subsequently by F. Castilla Contreras, B. Mongin and C. Vollrath, acting as Agents, and by G. Peretz, Barrister,

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),

composed of S. Gervasoni (Rapporteur), President, L. Madise and R. da Silva Passos, Judges,

Registrar: C. Heeren, Administrator,

having regard to the written part of the procedure and further to the hearing on 22 June 2017,

gives the following

Judgment

1. Background to the dispute

   A. Perindopril and its patents

   1 The Servier group, composed of Servier SAS and several subsidiaries (individually or jointly, ‘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.

   2 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.

   1. Compound patent

      3 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).

   2. Secondary patents

      4 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’).

      5 Servier filed new patents relating to erbumine and its manufacturing processes with the EPO between 2001 and 2005, 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’). 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.

   3. Second generation perindopril

      6 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.

      7 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. Servier launched perindopril arginine on the United Kingdom market in April 2008, whereas generic perindopril had already been on the market for several months.

      B. The applicants

      8 Teva Pharmaceutical Industries Ltd is a multinational pharmaceutical company that develops, produces and markets generic medicines for all major medical treatment categories. It also produces APIs for its own pharmaceutical production and for other manufacturers. Teva UK Ltd is a wholly owned subsidiary of Teva Pharmaceuticals Europe BV, which itself is a wholly owned subsidiary of Teva Pharmaceutical Industries (together or individually, ‘Teva’ or ‘the applicants’). Teva is one of the largest pharmaceutical companies in the world operating in the generic medicinal products sector.

      9 On 26 January 2006, Teva merged with Ivax Europe (‘Ivax’), a multinational pharmaceutical company which manufactures generic medicines and which therefore became a wholly owned subsidiary of Teva.

      C. Teva’s perindopril activities

      10 Before their merger, Teva and Ivax each developed their own perindopril project.

      11 Accordingly, between 1999 and 2005, Teva tried, without success, to source perindopril API from a number of suppliers.

      12 In 2003, following its failed negotiations with Servier concerning the conclusion of an agreement to market and supply Servier’s generic perindopril, Ivax started to develop its own perindopril. Accordingly, on 24 September 2003, it concluded a contract to supply perindopril API with Hetero Drugs Ltd and, on 21 December 2005, it concluded a manufacturing and supply agreement with Alembic Pharmaceuticals Ltd for the manufacture of perindopril as an end product from that API.

      13 In 2003, Ivax also started discussions with Krka Tovarna Zdravil d.d. (‘Krka’) which, at that time, was developing its own perindopril. Negotiations intensified in May 2006 following the merger of Ivax and Teva, but were ultimately unsuccessful and, on 18 May 2006, Teva announced to Krka its decision not to pursue their cooperation on perindopril in the United Kingdom.

      D. Disputes relating to perindopril

   1. Disputes before the EPO

      14 In 2004, 10 generic companies, including Norton Healthcare Ltd, a subsidiary of Ivax, filed opposition proceedings against the 947 patent before the EPO seeking the revocation of that patent on grounds of lack of novelty, lack of inventive step and insufficient disclosure of the invention.

      15 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. Seven companies brought an appeal against that decision. By decision of 6 May 2009, the EPO’s Technical Board of Appeal annulled the decision of the EPO’s Opposition Division of 27 July 2006 and revoked the 947 patent. Servier’s request for a revision of that decision was rejected on 19 March 2010.

      16 On 13 April 2005, Teva filed opposition proceedings against the 873 patent. The Opposition Division rejected that opposition on the ground, in particular, 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

      17 The validity of the 947 patent has also been disputed by generic companies before the courts of certain Member States, notably in the United Kingdom.

      (a) Dispute between Servier and Ivax

      18 On 9 August 2005, Ivax requested the revocation of the 947 patent, as validated in the United Kingdom (‘the UK 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 UK 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.

      (b) Dispute between Servier and Apotex

      19 On 1 August 2006, Servier brought an action for infringement before the High Court of Justice (England & Wales), Chancery Division (Patents Court) against Apotex Inc, claiming infringement of the UK 947 patent, since the latter had launched a generic version of perindopril in the United Kingdom on 28 July 2006. Apotex brought a counterclaim for annulment of the UK 947 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 UK 947 patent was invalid because it lacked novelty and inventive step over another patent held by Servier. Consequently, the injunction was lifted immediately and Apotex was able to resume selling its...