"(1) For the purposes of Articles 13 and 19 of Council Regulation (EC) No 1768/92, is an authorisation a ‘first authorisation to place ... on the market in the Community’, if it is granted in pursuance of a national law which is compliant with Council Directive 65/65/EEC, or is it necessary that it be established in addition that, in granting the authorisation in question, the national authority followed an assessment of data as required by the administrative procedure laid down in that directive?This morning Advocate General Mengozzi gave the following somewhat bifurcated advice to the Court:
(2) For the purposes of Articles 13 and 19 of Council Regulation (EC) No 1768/92, does the expression ‘first authorisation to place ... on the market in the Community’ include authorisations which had been permitted by national law to co-exist with an authorisation regime which complies with Council Directive 65/65/EEC?
(3) Is a product which is authorised to be placed on the market for the first time in the EEC without going through the administrative procedure laid down in Council Directive 65/65/EEC within the scope of Council Regulation (EC) 1768/92 as defined by Article 2?
(4) If not, is an SPC granted in respect of such a product invalid?".
"95. Council Regulation ... 1768/92 ... must be interpreted, pursuant to Article 2 thereof, as meaning that products placed on the market as medicinal products in Community territory before obtaining a marketing authorisation in accordance with Council Directive 65/65 ...or with Council Directive 81/851 ... do not fall within the scope of the regulation.This post is simply to alert readers to the availability of the Opinion. Further comment will follow.
Supplementary protection certificates granted for such products must be deemed to be invalid.’
96. Should the Court not adopt that solution, I propose that it should give the following answers to the first and second questions ...
‘A marketing authorisation granted by the authorities of a Member State in accordance with the national provisions transposing Directive 65/65 may constitute the first marketing authorisation in the Community for the purpose of Articles 13 and 19 of Regulation No 1768/92, even when the administrative procedure for which the directive provides has not been implemented or has not been properly implemented, particularly as regards the carrying out of the toxicological and pharmacological tests and the clinical trials required by the directive.
A marketing authorisation granted by the competent authorities of a Member State, under the transitional arrangements provided for by Article 24 of Directive 65/65, in conjunction with Article 39 of Second Council Directive 75/319 ...as amended ..., may also constitute the first marketing authorisation of the product in the Community, on the basis of a marketing authorisation granted before the transposition of Directive 65/65 into the legal order of that Member State.
For the purposes of the application of Articles 13 and 19 of Regulation No 1768/92, a marketing authorisation granted for a use of the product as a medicinal product different from the use or uses protected by the patent constituting the basic patent under Article 1(c) of that regulation may also be regarded as the first marketing authorisation in the Community".