Source: EURLEX
Language: en
Format: md

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| 8.10.2011 | EN | Official Journal of the European Union | C 298/3 |

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Judgment of the Court (Second Chamber) of 28 July 2011 (reference for a preliminary ruling from the Court of Appeal (England and Wales) (Civil Division) (United Kingdom)) — Generics (UK) Ltd v Synaptech Inc

(Case C-427/09)[(1)](#ntr1-C_2011298EN.01000301-E0001)

(Patent law - Medicinal products - Supplementary protection certificate for medicinal products - Regulation (EEC) No 1768/92 - Article 2 - Scope)

2011/C 298/04

Language of the case: English

Referring court

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

Parties to the main proceedings

Applicant: Generics (UK) Ltd

Defendant: Synaptech Inc

Re:

Reference for a preliminary ruling — Court of Appeal (England and Wales) (Civil Division) — Interpretation of Article 13(1) 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](./../../../legal-content/EN/AUTO/?uri=OJ:L:1992:182:TOC)) — Concept of first authorisation to place the product on the market — Account taken only of authorisations issued 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 (OJ, English Special Edition 1965-1966, p. 24) — Authorisation delivered in accordance with the legislation applicable in Austria before the latter acceded to the EEA.

Operative part of the judgment

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 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, as that scope is defined in Article 2 of that regulation, as amended, and may not be the subject of a supplementary protection certificate.

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