Judgments nº T-680/14 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-680/14

(Competition - Agreements, decisions and concerted practices - Market for perindopril, a medicinal product intended for the treatment of cardiovascular diseases, in its originator and generic versions - Decision finding an infringement of Article 101 TFEU - Patent dispute settlement agreement - Technology acquisition agreement - Restriction of competition by object - Balance between competition law and patent law - Fines)

In Case T-680/14,

Lupin Ltd, established in Maharashtra (India), represented initially by M. Pullen, R. Fawcett-Feuillette, Solicitors, M. Hoskins QC, V. Wakefield, Barrister and M. Boles, Solicitor, and subsequently by M. Hoskins, V. Wakefield, M. Boles, K. Vernon and S. Smith, Solicitors, and lastly by M. Hoskins, V. Wakefield, S. Smith and C. Wall, Solicitor,

applicant,

v

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

defendant,

APPLICATION under Article 263 TFEU for partial 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 applicant, and, in the alternative, for annulment or reduction of the fine imposed on the applicant 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 4 July 2017,

gives the following

Judgment

1. Background to the dispute

   A. Perindopril

   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 (‘API’) of perindopril, 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. The compound patent

      3 The perindopril compound patent (patent EP0049658) was filed with the European Patent Office (EPO) on 29 September 1981. That 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 with the EPO relating to processes for the manufacture of the perindopril compound with an expiry date of 16 September 2008: patents EP0308339, EP0308340 (‘the 340 patent’), EP0308341 and EP0309324.

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

      6 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.

      7 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. Servier filed, for example, patent applications relating to the 947 patent in Bulgaria (BG 107 532), the Czech Republic (PV 2003-357), Estonia (P 200 300 001), Hungary (HU 225340), Poland (P 348492) and Slovakia (PP 0149-2003). 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.

      B. The applicant

      8 Lupin Ltd is the parent company, registered in India, of the companies which form part of the Lupin group (individually or jointly, ‘Lupin’ or ‘the applicant’).

      C. Disputes relating to perindopril

   1. Disputes before the EPO

      9 Ten generic companies, including Niche Generics Ltd (‘Niche’), Krka Tovarna Zdravil d.d. (‘Krka’), Lupin and Norton Healthcare Ltd, a subsidiary of Ivax Europe 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.

      10 On 27 July 2006, the EPO’s Opposition Division confirmed the validity of that patent following minor amendments to Servier’s original claims. Seven companies brought an appeal against the Opposition Division’s 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 decision of the Opposition Division and revoked the 947 patent. Servier’s request for a revision of that decision was rejected on 19 March 2010.

   2. Disputes before the national courts

      11 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 Krka

      12 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.

      13 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 and 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.

      14 On 3 October 2006, the High Court of Justice (England and 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.

      (b) Dispute between Servier and Lupin

      15 On 18 October 2006, Lupin submitted an application to the High Court of Justice (England and 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.

      (c) Dispute between Servier and Apotex

      16 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 patent EP0308341. 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). On 9 October 2008, the High Court of Justice (England & Wales), Chancery Division (Patents Court) awarded damages to Apotex in the amount of 17.5 million pounds sterling (GBP) on account of the loss of revenue suffered during the period when the injunction was in force.

      D. Patent dispute settlements

      17 Servier entered into a series of settlement agreements with a number of generic companies with which it was involved in patent disputes.

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

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

      20 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 European Economic Area (EEA) (Clause 1.3 of the Lupin agreement). 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 of the Lupin...