Judgment of the Court (Grand Chamber): Teva UK Ltd and Others v Gilead Sciences Inc.
JUDGMENT OF THE COURT (Grand Chamber) (Reference for a preliminary ruling â Medicinal products for human use â Treatment of human immunodeficiency virus (HIV) â Originator medicines and generic medicines â Supplementary protection certificate â Regulation (EC) No 469/2009 â Article 3(a) â Conditions for obtaining â Concept of a âproduct protected by a basic patent in forceâ â Criteria for assessment) In Case Câ121/17, REQUEST for a preliminary ruling under Article 267 TFEU from the High Court of Justice (England & Wales), Chancery Division (Patents Court), made by decision of 23 February 2017, received at the Court on 8 March 2017, in the proceedings Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK) Ltd, trading as âMylanâ, v Gilead Sciences Inc., THE COURT (Grand Chamber), composed of K. Lenaerts, President, A. Tizzano, Vice-President, R. Silva de Lapuerta, M. IleÅ¡iÄ, J.L. da Cruz Vilaça, C.G. Fernlund and C. Vajda, Presidents of Chambers, J.-C. Bonichot, A. Arabadjiev, C. Toader, M. Safjan, S. Rodin, and K. Jürimäe (Rapporteur), Judges, Advocate General: M. Wathelet, Registrar: L. Hewlett, Principal Administrator, having regard to the written procedure and further to the hearing on 20 February 2018, after considering the observations submitted on behalf of: â Teva UK Ltd, by D. Alexander, QC, and S. Carter and L. Lane, Barristers, instructed by C. Tunstall, Solicitor, â Accord Healthcare Ltd, by D. Alexander, QC and K. Pickard, Barrister, instructed by S. Ma, Solicitor, â Lupin (Europe) Ltd and Lupin Ltd, by D. Alexander, QC, and J. Riordan, Barrister, instructed by D. Rose, Solicitor, â Generics (UK) Ltd, trading as âMylanâ, by D. Alexander, QC, and J. Delaney, Barrister, instructed by M. Royle, Solicitor, â Gilead Sciences Inc., by T. Mitcheson, QC, and J. Whyte, Barrister, instructed by S. Moore, Solicitor, â the United Kingdom Government, by G. Brown, acting as Agent, and by N. Saunders, Barrister, â the Greek Government, by M. Tassopoulou, D. Tsagkaraki and S. Papaioannou, acting as Agents, â the Latvian Government, by I. Kucina, acting as Agent, â the Netherlands Government, by M.K. Bulterman and M. Gijzen, acting as Agents, â the European Commission, by Ã. Gippini Fournier and J. Samnadda, acting as Agents, after hearing the Opinion of the Advocate General at the sitting on 25 April 2018, gives the following Judgment 1 This request for a preliminary ruling concerns the interpretation of Article 3(a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ 2009 L 152, p. 1). 2 The request has been made in proceedings between Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd and Generics (UK) Ltd, trading as âMylanâ, on the one hand and, on the other, Gilead Science Inc. (âGileadâ) concerning the validity of a supplementary protection certificate (âthe SPCâ) granted to the latter for a pharmaceutical product for the treatment of human immunodeficiency virus (âHIVâ). Legal context European Patent Convention 3 Under the heading âExtent of protectionâ, Article 69 of the Convention on the Grant of European Patents, signed in Munich on 5 October 1973, in the version applicable at the material time in the main proceedings (âthe EPCâ), stipulates as follows: â(1)   The extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims. (2)   For the period up to grant of the European patent, the extent of the protection conferred by the European patent application shall be determined by the claims contained in the application as published. However, the European patent as granted or as amended in opposition, limitation or revocation proceedings shall determine retroactively the protection conferred by the application, in so far as such protection is not thereby extended.â 4 Article 1 of the Protocol on the Interpretation of Article 69 of the EPC, which forms an integral part of the convention pursuant to Article 164(1) thereof, provides as follows: âArticle 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.â European Union law 5 Recitals 3 to 5, 7, 9 and 10 of Regulation No 469/2009 state as follows: â(3) Medicinal products, especially those that are the result of long, costly research will not continue to be developed in the [Union] and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research. (4) At the moment the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research. (5) This situation leads to a lack of protection which penalises pharmaceutical research. ⦠(7) A uniform solution at [Union] level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the [Union] and thus directly affect the functioning of the internal market. ⦠(9) The duration of the protection granted by the [SPC] should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a[n SPC] should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains authorisation to be placed on the market in the [Union]. (10) All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken
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