Keywords
Summary

Keywords

1. Approximation of laws – Uniform laws – Industrial and commercial property – Patent right – Supplementary protection certificate for medicinal products

(Council Regulation No 1768/92, Art. 1(b))

2. Approximation of laws – Uniform laws – Industrial and commercial property – Patent right – Supplementary protection certificate for medicinal products

(Council Regulation No 1768/92, Art. 1(b))

Summary

1. In the absence of any definition of the concept of ‘active ingredient’ of a medicinal product in Regulation No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products, the meaning and scope of those terms must be determined by considering the general context in which they are used and their usual meaning in everyday language.

(see para. 17)

2. Article 1(b) of Council Regulation No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products must be interpreted so as not to include in the concept of ‘combination of active ingredients of a medicinal product’ a combination of two substances, only one of which has therapeutic effects of its own for a specific indication, the other rendering possible a pharmaceutical form of the medicinal product which is necessary for the therapeutic efficacy of the first substance for that indication.

(see para. 31, operative part)