INTERNATIONAL TREATIES
EC Treaty
Judgment of the Court of Justice of the European Communities dated 23 January 1997
(Case C-181/95, Biogen Inc. v. Smithkline Beecham Biologicals SA)*
Headword: Biogen/Smithkline
Regulation (EEC) No. 1768/921: Articles 1(c), 3(b) and (c), 6, 8(1)(b) and 13
Keyword: "Supplementary protection certificate for medicinal products - Entitlement to certificate where there are several basic patents - Marketing authorisation"
Headnotes
1. Approximation of laws - uniform legislation - industrial and commercial property - patent right - supplementary protection certificate for medicinal products - medicinal product protected by several basic patents - entitlement of each basic patent holder to a certificate (Council Regulation No. 1768/92, Articles 1(c), 3(c) and 6)
2. Approximation of laws - uniform legislation - industrial and commercial property - patent right - supplementary protection certificate for medicinal products - conditions for obtaining - provision of a copy of the marketing authorisation - obligation of the holder of the marketing authorisation to provide a copy to the holder of a basic patent - none - right of the competent national authority to refuse to grant a certificate failing presentation by the applicant of a copy of the authorisation - excluded (Council Regulation No. 1768/92 Article 8(1)(b))
Order
1. Where a medicinal product is covered by several basic patents, Council Regulation (EEC) No. 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products does not preclude the grant of a supplementary protection certificate to each holder of a basic patent.
2. Regulation No. 1768/92 does not require the holder of the marketing authorisation to provide the patent holder with a copy of that authorisation, referred to in Article 8(1)(b) of the Regulation.
3. Where the basic patent and the authorisation to place the product on the market as a medicinal product are held by different persons and the patent holder is unable to provide a copy of that authorisation in accordance with Article 8(1)(b) of Regulation No. 1768/92, an application for a certificate must not be refused on that ground alone.
EU 3/97
* Official headnotes and order; the full text of the decision is published in the Court of Justice Reports 1997, I-357 and, in slightly abridged form, in Mitt. 1997, 63, and GRUR Int. 1997, 363.