Judgments nº T-682/14 of Tribunal General de la Unión Europea, December 12, 2018

Resolution DateDecember 12, 2018
Issuing OrganizationTribunal General de la Unión Europea
Decision NumberT-682/14

(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 - Potential competition - Restriction of competition by object - Balance between competition law and patent law - Imputation of the unlawful conduct - Fines)

In Case T-682/14,

Mylan Laboratories Ltd, established in Hyderabad (India),

Mylan, Inc., established in Canonsburg, Pennsylvania (United States),

represented by S. Kon, C. Firth and C. Humpe, Solicitors,

applicants,

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 S. Kingston, Barrister-at-law,

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 annulment or 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 27 June 2017,

gives the following

Judgment

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, ‘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.

  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, EP0308341 (respectively, ‘the 339 patent’, ‘the 340 patent’ and ‘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’). 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) on 17 February 2003. That 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.

    B. The applicants

    8 Matrix Laboratories Ltd (‘Matrix’) is an Indian company which primarily develops, produces and markets APIs for generic companies.

    9 Following a number of shareholding acquisitions, including the acquisition of a majority shareholding on 8 January 2007, the second applicant, Mylan Inc., has held between 97 and 98% of Matrix’s capital since 2011. Matrix has been known as Mylan Laboratories Ltd, the name of the first applicant, since 5 October 2011.

    C. The applicants’ perindopril activities

    10 On 20 May 2003, Matrix merged with Medicorp Technologies India Ltd (‘Medicorp’), which, on 26 March 2001, concluded a development and licensing agreement with another company, of which Niche Generics Ltd (‘Niche’) was the successor, with a view to marketing a generic version of perindopril (‘the Niche/Matrix agreement’). An amendment to that agreement, concluded on 30 March 2004, provided that Matrix was to take over all of Medicorp’s responsibilities and obligations under the Niche/Matrix agreement. Under that agreement, the two companies were to market generic perindopril in the European Union, with Matrix responsible primarily for developing and supplying perindopril’s API, while Niche was responsible primarily for taking the necessary steps to obtain marketing authorisations and for the business strategy.

    11 On 27 March 2003, Medicorp had also concluded an agreement for the development and manufacture of perindopril tablets with Niche’s parent company, Unichem Laboratories Ltd (‘Unichem’), under which Medicorp would undertake to develop perindopril’s API and to provide it to Unichem, which was responsible for the production of perindopril in final dosage form. The amendment to that agreement, concluded on 12 April 2004, provided that Matrix was to take over all of Medicorp’s responsibilities and obligations under the agreement.

    D. Disputes relating to perindopril

  4. Dispute before the EPO

    12 In 2004, 10 generic companies 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.

    13 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 Opposition Division and revoked the 947 patent. Servier’s request for a revision of that decision was rejected on 19 March 2010.

  5. Disputes before the national courts

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

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

    15 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 the generic version of perindopril, developed in partnership with Matrix (see paragraph 10 above). On 9 July 2004 Niche served on Servier a counterclaim for a declaration of invalidity of the 947 patent.

    16 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.

    17 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.

    (b) Dispute between Servier and Apotex

    18 On 1 August 2006, Servier brought an action for infringement before the High Court of Justice (England & Wales), Chancery Division (Patents Court), against the company Apotex, claiming infringement of the 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 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) (Civil Division), 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) dismissed Servier’s appeal against the judgment of the High Court of Justice (England & Wales), Chancery Division (Patents Court).

    E. The agreement concluded between Matrix and Servier

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

    20 On 8 February 2005, Servier concluded a settlement agreement (‘the Agreement’) with Matrix. The territorial scope...

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