Keywords
Summary

Keywords

Approximation of laws – Uniform legislation – Industrial and commercial property – Patent right – Supplementary protection certificate for medicinal products – Field of application

(Council Regulation No 1768/92, Art. 2; Council Directive 65/65)

Summary

A product which was placed on the market in the European Community as a medicinal product for human use before a marketing authorisation was obtained in accordance with Directive 65/65, on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended by Directive 89/341 and, in particular, without undergoing safety and efficacy testing, does not fall within the field of application of Regulation No 1768/92, 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 field is defined in Article 2 of that regulation, as amended, and may not be the subject of a supplementary protection certificate.

(see para. 36, operative part)