Merck Sharp & Dohme Corp. v Deutsches Patent- und Markenamt (C-125/10)

Judgment of 8 Dec 2011

law://eu/cjeu/2010/c-125-10/para_6@2026-11-13

6Under Article 3 of Regulation No 1768/92, entitled ‘Conditions for obtaining a[n] [SPC]’:‘A[n] [SPC] shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:(a) the product is protected by a basic patent in force;(b) a valid [marketing authorisation] as a medicinal product has been granted in accordance with [Council] Directive 65/65/EEC [of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products (OJ, English Special Edition 1965 – 1966, p.24)), as amended by Council Directive 89/341/EEC of 3 May 1989 (OJ 1989 L 142, p. 11)] or [Council] Directive 81/851/EEC [of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products (OJ 1989 L 317, p. 1), as amended by Council Directive 90/676/EEC Of 13 December 1990 (OJ 1990 L 373, p. 15)], as appropriate …;(c) the product has not already been the subject of a[n] [SPC];(d) the [marketing authorisation] referred to in (b) is the first [marketing authorisation] as a medicinal product.’

Merck Sharp & Dohme Corp. v Deutsches Patent- und Markenamt (C-125/10)

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