お知らせ
2011 08. 01.
European Court of Justice
In Europe, a national patent generally has a term of 20 years starting from the filing date. In order to at least partially compensate for the time lost to obtain a marketing authorization for a medicament, the Council of the EU has adopted the Council Regulation (EEC) No. 1768/92 of June 18, 1992, concerning the creation of a Supplementary Protection Certificate (SPC) for medicaments, wherein the requirements for a patent term extension are stipulated. In order to obtain an SPC, several prerequisites have to be met. In particular, a valid authorization to place a product protected by a patent on the market as a medicament has to be granted and said valid authorization must be the first authorization to place the product on the market as a medicament.
On July 28, 2011, the European Court of Justice published its decisions C 427/09 and C-195/09. In these decisions, the European Court of Justice commented on the question what authorization should be regarded as a valid authorization to place a product on the market in the sense of EEC No. 1768/92. In both cases, the product in question had been put on the market according to national law within the European Union. However, none of the products in question had gone through the administrative procedure laid down in the 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 products.
In both cases, the European Court of Justice decided that an SPC can only be obtained for a product which has gone through the administrative procedure laid down in the Council Directive 65/65/EEC. In particular, according to the European Court of Justice, a product which has not undergone the safety and efficacy testing laid out in the Council Directive 65/65/EEC is not within the scope of EEC No. 1768/92 concerning the creation of a supplementary protection certificate for medicinal products. Accordingly, an SPC cannot be granted for such a product.
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