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Supplementary protection certificates

Supplementary protection certificates can be granted after the expiry of a patent for the invention, provided that the subject-matter of the patent is a product, a process to obtain the product or an application of the product, for which an official authorisation is needed prior to commercial exploitation.

'Product' means the active ingredient or combination of active ingredients of a medicinal product or plant protection product.

Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version) and Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, with all subsequent amendments, are directly applicable for supplementary protection certificates in Slovenia. For the purpose of implementing those Regulations, the Government of the Republic of Slovenia issued a Decree implementing Council Regulations concerning the creation of a supplementary protection certificate for medicinal products and for plant protection products.

Duration of a supplementary protection certificate

Supplementary protection certificate takes effect immediately after the expiry of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was filed and the date of the first authorization to place the product on the market in the Community (EC Member States, Norway, Iceland and Liechtenstein), reduced by a period of five years. However, the duration of the certificate may not exceed five years from the date on which it takes effect.

The periods laid down in previous paragraph shall be extended by six months in the case where Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for pediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 applies. In that case, the duration of the period laid down in previous paragraph may be extended only once.

Note:

Swiss marketing authorizations are effective (with possible time delay) in Liechtenstein and count as authorizations issued in the Community.

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