Judgments nº T-684/14 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-684/14

(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 - Licensing agreement - Technology acquisition agreement - Restriction of competition by object - Restriction of competition by effect - Balance between competition law and patent law)

In Case T-684/14,

Krka Tovarna Zdravil d.d., established in Novo Mesto (Slovenia), represented by T. Ilešič and M. Kocmut, lawyers,

applicant,

v

European Commission, represented by F. Castilla Contreras, B. Mongin and C. Vollrath, acting as Agents, assisted by D. Bailey, 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,

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 20 June 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 (‘the 341 patent’) and EP0309324.

   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’), 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 (‘the EPC’). 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 The Krka group is composed of the parent company, Krka Tovarna Zdravil d.d., and several subsidiaries in Slovenia and other countries (individually or jointly ‘Krka’ or ‘the applicant’).

   C. Disputes relating to perindopril

   1. Disputes before the EPO

   9 Ten generic companies, including Niche Generics Ltd, Krka, Lupin Ltd and Norton Healthcare Ltd, a subsidiary of Ivax Europe which subsequently merged with Teva Pharmaceuticals Ltd 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. On 27 July 2006, the EPO’s Opposition Division 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 Generics 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.

   2. Disputes before the national courts

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

   (a) Dispute between Servier and Krka

   11 On 30 May 2006, Servier applied for an interim injunction in Hungary 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.

   12 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. 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 Apotex

   13 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).

   14 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. On 29 March 2011, however, the High Court of Justice (England and 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).

   15 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

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

   17 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.

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

   19 In accordance with the settlement agreement with Krka, in force until the expiry or the revocation of the 947 or...