Official Journal of the European Union

C 298/2

(Case C-195/09)(1)

(Patent law - Medicinal products - Supplementary protection certificate for medicinal products - Regulation (EEC) No 1768/92 - Article 2 - Scope - Safety and efficacy testing laid down by Directive 65/65/EEC - Absence - Invalidity of the certificate)

2011/C 298/02

Language of the case: English

Referring court

Parties to the main proceedings

Applicant: Synthon BV

Defendant: Merz Pharma GmbH & Co KGaA

Re:

Reference for a preliminary ruling — High Court of Justice (Chancery Division) — Interpretation of Articles 13 and 19 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ 1992 L 182, p. 1) — Concept of first authorisation to place the product on the market — Authorisation issued in accordance with a national Law applying 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) — Obligation on the national authority issuing the authorisation to have assessed the particulars as provided for by that directive

Operative part of the judgment

1.Article 2 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as amended by the Act concerning the conditions of accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded, must be interpreted as meaning that a product, such as that at issue in the main proceedings, which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation 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 medicinal products, as amended by Council Directive 89/341/EEC of 3 May 1989, and, in particular, without undergoing safety and efficacy testing, is not within the scope of Regulation No 1768/92, as amended, and may not, therefore, be the subject of a supplementary protection certificate.

2.A supplementary protection certificate granted for a product outside the scope of Regulation No 1768/92, as amended, as that scope is defined in Article 2 of that regulation, is invalid.

(1)

OJ C 193, 15.8.2009.