Language of document :

Reference for a preliminary ruling from Court of Appeal (Civil Division) (England and Wales) made on 28 October 2009 - Generics (UK) Ltd v Synaptech Inc

(Case C-427/09)

Language of the case: English

Referring court

Court of Appeal (Civil Division) (England and Wales)

Parties to the main proceedings

Applicant: Generics (UK) Ltd

Defendant: Synaptech Inc

Questions referred

For the purposes of Article 13(1) of Council Regulation (EEC) No 1768/921, is the "first authorisation to place the product on the market in the Community" the first authorisation to place the product on the market in the Community which was issued in accordance with Council Directive 65/65/EEC2 (now replaced with Directive 2001/83/EC3) or will any authorisation that enables the product to be placed on the market in the Community or EEA suffice?

If, for the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, an "authorisation to place the product on the market in the Community" must have been issued in accordance with Directive 65/65/EEC (now replaced with Directive 2001/83/EC), is an authorisation that was granted in 1963 in Austria in accordance with the national legislation in force at that time (which did not comply with the requirements of Directive 65/65/EEC) and that was never amended to comply with Directive 65/65/EEC and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65/EEC for that purpose?

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1 - Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal productsOJ L 182, p. 1

2 - 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 productsOJ 22, p. 369

3 - Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human useOJ L 311, p. 67