Keywords
Summary

Keywords

Approximation of laws — Uniform legislation — Industrial and commercial property — Patent law — Supplementary protection certificate for medicinal products — Authorisation to place a product on the market — Automatic recognition by a State of the European Economic Area of an authorisation to place a product on the Swiss market — Regarded as first authorisation to place a product on the market in the Community

(EEA Agreement, Annex II, as amended by Annex 2 to the Decision of the EEA Council No 1/95; Council Regulation No 1768/92, Art. 13)

Summary

Article 13 of Regulation No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products is to be read, for the purposes of the application of the Agreement on the European Economic Area, as providing that the certificate is to take effect at the end of the lawful term 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 lodged and the date of the first authorisation to place the product on the market in the territory of one of the States covered by the EEA Agreement, reduced by a period of five years.

The EEA Agreement, Annex II to which, as amended by Annex 2 to the Decision of the EEA Council No 1/95 on the entry into force of the Agreement on the European Economic Area for the Principality of Liechtenstein, permits the latter to apply, in parallel to the Community legislation, the Swiss technical regulations and standards deriving from its regional union with Switzerland, recognises that two types of marketing authorisation may co-exist in the Principality of Liechtenstein, namely, first, marketing authorisations issued by the Swiss authorities, which are automatically recognised in Liechtenstein, and, second, marketing authorisations issued in Liechtenstein in accordance with the Community legislation.

It thus follows from Article 13 of Regulation No 1768/92, read in conjunction with the EEA Agreement, as amended, that an authorisation to place a medicinal product on the market issued by the Swiss authorities and automatically recognised in Liechtenstein within the framework of its regional union with Switzerland must be regarded as the first authorisation to place the product on the market within the meaning of Article 13.

(see paras 26, 28-30, 33, operative part)