Judgment_paragraph 5 · Synthon BV v Merz Pharma GmbH & Co. KGaA (C-195/09)

5Article 2 of that regulation, entitled ‘Scope’, is worded as follows:‘Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Council Directive 65/65/EEC [of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to 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; “Directive 65/65”)] 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 1981 L 317, p. 1), as amended by Council Directive 90/676/EEC of 13 December 1990 (OJ 1990 L 373, p. 15)], may, under the terms and conditions provided for in this Regulation, be the subject of [an SPC].’

Synthon BV v Merz Pharma GmbH & Co. KGaA (C-195/09)

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