Keywords

Summary



Keywords

1. Approximation of laws — Uniform laws — Industrial and commercial property — Patent law — Supplementary protection certificate for medicinal products — Grant pursuant to the transitional provision contained in Article 19 of Regulation No 1768/92 — Condition — First authorisation to place on the market in the Community obtained after a fixed reference date — Different dates for different Member States — Whether the principle of equality of treatment or the obligation to state reasons has been infringed — No such infringement — (Council Regulation No 1768/92, Art. 19)

2. Approximation of laws — Uniform laws — Industrial and commercial property — Patent law — Supplementary protection certificate for medicinal products — Grant pursuant to the transitional provision contained in Article 19 of Regulation No 1768/92 — Condition — First authorisation to place on the market in the Community — Definition — (Council Regulation No 1768/92, Art. 19)

3. Approximation of laws — Uniform laws — Industrial and commercial property — Patent law — Supplementary protection certificate for medicinal products — Grant pursuant to the transitional provision contained in Article 19 of Regulation No 1768/92 — First authorisation to place on the market in the Community prior to the reference date fixed — Invalidity of the certificate — (Council Regulation No 1768/92, Arts 15 and 19)

Summary

1. Article 19 of Regulation No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products, which provides that any product which, on the date on which the Regulation enters into force, is protected by a valid patent and for which the first authorisation to place it on the market as a medicinal product in the Community was obtained after the reference date fixed may be granted such a certificate, does not infringe either the principle of equality of treatment or the obligation to state reasons, in so far as it lays down different dates for different Member States.

see paras 40, 47, operative part 1

2. So far as concerns medicinal products for human use, the phrase "first authorisation to place ... on the market ... in the Community" , in Article 19(1) of Regulation No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products, refers solely to the authorisation required under the provisions on medicinal products, within the meaning of Directive 65/65 relating to proprietary medicinal products, and does not therefore refer to authorisations required under legislation on pricing of or reimbursement for medicinal products.

Moreover, that phrase refers to the first authorisation granted in any of the Member States rather than to only the first authorisation granted in the Member State in which the application was submitted.

see paras 60, 74, 79, operative part 2

3. A supplementary protection certificate which, contrary to the requirements of Article 19 of Regulation No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products, has been granted in a case where the first marketing authorisation in the Community was obtained prior to the reference date fixed by that provision is invalid pursuant to Article 15 thereof. Failure to comply with the requirement that the first marketing authorisation in the Community should have been obtained after that date would jeopardise the practical effect of that provision, which is to ensure that a certificate can no longer be granted where the first marketing authorisation in the Community was obtained too long ago.

see paras 87, 92, operative part 3