This document is an excerpt from the EUR-Lex website
Document 62017CA0121
Case C-121/17: Judgment of the Court (Grand Chamber) of 25 July 2018 (request for a preliminary ruling from the High Court of Justice (Chancery Division) — United Kingdom) — Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK) Ltd, trading as ‘Mylan’ v Gilead Sciences Inc. (Reference for a preliminary ruling — Medicinal products for human use — Treatment of human immunodeficiency virus (HIV) — Originator medicines and generic medicines — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3(a) — Conditions for obtaining — Concept of a ‘product protected by a basic patent in force’ — Criteria for assessment)
Case C-121/17: Judgment of the Court (Grand Chamber) of 25 July 2018 (request for a preliminary ruling from the High Court of Justice (Chancery Division) — United Kingdom) — Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK) Ltd, trading as ‘Mylan’ v Gilead Sciences Inc. (Reference for a preliminary ruling — Medicinal products for human use — Treatment of human immunodeficiency virus (HIV) — Originator medicines and generic medicines — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3(a) — Conditions for obtaining — Concept of a ‘product protected by a basic patent in force’ — Criteria for assessment)
Case C-121/17: Judgment of the Court (Grand Chamber) of 25 July 2018 (request for a preliminary ruling from the High Court of Justice (Chancery Division) — United Kingdom) — Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK) Ltd, trading as ‘Mylan’ v Gilead Sciences Inc. (Reference for a preliminary ruling — Medicinal products for human use — Treatment of human immunodeficiency virus (HIV) — Originator medicines and generic medicines — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3(a) — Conditions for obtaining — Concept of a ‘product protected by a basic patent in force’ — Criteria for assessment)
OJ C 328, 17.9.2018, p. 13–14
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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17.9.2018 |
EN |
Official Journal of the European Union |
C 328/13 |
Judgment of the Court (Grand Chamber) of 25 July 2018 (request for a preliminary ruling from the High Court of Justice (Chancery Division) — United Kingdom) — Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK) Ltd, trading as ‘Mylan’ v Gilead Sciences Inc.
(Case C-121/17) (1)
((Reference for a preliminary ruling - Medicinal products for human use - Treatment of human immunodeficiency virus (HIV) - Originator medicines and generic medicines - Supplementary protection certificate - Regulation (EC) No 469/2009 - Article 3(a) - Conditions for obtaining - Concept of a ‘product protected by a basic patent in force’ - Criteria for assessment))
(2018/C 328/15)
Language of the case: English
Referring court
High Court of Justice (Chancery Division)
Parties to the main proceedings
Applicants: Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK) Ltd, trading as ‘Mylan’
Defendant: Gilead Sciences Inc.
Operative part of the judgment
Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
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the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and |
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each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent. |