Case C-493/12: Judgment of the Court (Third Chamber) of 12 December 2013 (request for a preliminary ruling from the High Court of Justice (Chancery Division) — United Kingdom) — Eli Lilly and Company Ltd v Human Genome Sciences Inc (Medicinal products for human use — Supplementary protection certificate — Regulation (EC) No 469/2009 — Article 3 — Conditions for obtaining such a certificate — Concept of a ‘product protected by a basic patent in force’ — Criteria — Wording of the claims of the basic patent — Precision and specificity — Functional definition of an active ingredient — Structural definition of an active ingredient — European Patent Convention)
Date: 2013-12-12
Institutions: Court of Justice
Subjects: medicinal product, patent, pharmaceutical legislation








C_2014045EN.01001401.xml










15.2.2014   


EN


Official Journal of the European Union


C 45/14





Judgment of the Court (Third Chamber) of 12 December 2013 (request for a preliminary ruling from the High Court of Justice (Chancery Division) — United Kingdom) — Eli Lilly and Company Ltd v Human Genome Sciences Inc
(Case C-493/12) (1)

(Medicinal products for human use - Supplementary protection certificate - Regulation (EC) No 469/2009 - Article 3 - Conditions for obtaining such a certificate - Concept of a ‘product protected by a basic patent in force’ - Criteria - Wording of the claims of the basic patent - Precision and specificity - Functional definition of an active ingredient - Structural definition of an active ingredient - European Patent Convention)
2014/C 45/24
Language of the case: English

Referring court

High Court of Justice (Chancery Division)

Parties to the main proceedings


Applicant: Eli Lilly and Company Ltd

Defendant: Human Genome Sciences Inc

Re:

Interpretation of Article 3(a) and (c) 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) — Conditions for obtaining a certificate — Concept of a ‘product protected by a basic patent in force’ — Criteria for assessment — Application of criteria to products not composed of a combination of medicinal products and medical devices

Operative part of the judgment

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 must be interpreted as meaning that, in order for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of that provision, it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Where the active ingredient is covered by a functional formula in the claims of a patent issued by the European Patents Office, Article 3(a) of that regulation does not, in principle, preclude the grant of a supplementary protection certificate for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention on the Grant of European Patents and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court.


(1)  OJ C 9, 12.1.2013.