Case C‑493/12

Eli Lilly and Company Ltd

v

Human Genome Sciences Inc

(Request for a preliminary ruling from the High Court of Justice (England and Wales), Chancery Division (Patents Court))

‛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’

Summary — Judgment of the Court (Third Chamber), 12 December 2013

1. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Conditions for granting — Active ingredient protected by a basic patent in force — Concept — Criteria for assessment — Wording of the claims of the basic patent — Need for a structural definition of the active ingredient — None — Functional definition of that active ingredient — Lawfulness — Conditions — Precision and specificity — Determination by the national court

   (European Parliament and Council Regulation No 469/2009, Art. 3(a))

2. Approximation of laws — Uniform legislation — Industrial and commercial property — Patent right — Supplementary protection certificate for medicinal products — Purpose

   (European Parliament and Council Regulation No 469/2009)

1.  Article 3(a) of Regulation No 469/2009 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.

   With regard to the requirements laid down by the Convention on the Grant of European Patents, the Court does not have jurisdiction to interpret the provisions of that convention, since, unlike the Member States, the European Union has not acceded to the convention. The Court cannot, therefore, provide further guidance to the referring court concerning the manner in which it is determine the extent of the claims of a patent issued by the European Patents Office.

   (see paras 40, 44, operative part)

2.  See the text of the decision.

   (see paras 41-43)