Generics (UK) Ltd v Synaptech Inc, Opinion of Advocate General Mengozzi, 31 March 2011, Case C-427/09
"In the light of all of the foregoing considerations and, without prejudice to the observations at points 33 to 35 above, I propose that the following reply be given to the questions referred by the Court of Appeal for a preliminary ruling:
(1) A marketing authorisation for a medicinal product granted by the competent authorities of a Member State pursuant to the transitional arrangements introduced by Article 24 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products – in conjunction with Article 39 of Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, and as amended by Article 37 of that directive – on the basis of a marketing authorisation granted prior to the transposition of Directive 65/65 into the legal order of that Member State, may constitute the first marketing authorisation for the purposes of Article 13 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products.
For the purposes of the application of Article 13 of Regulation No 1768/92, an authorisation granted for use of a product, as a medicinal product, other than that or those protected by the patent which is the basic patent within the meaning of Article 1(c) of the regulation, may also constitute the first authorisation to place the product on the market in the Community.
(2) A marketing authorisation for a medicinal product granted by the competent Austrian authorities in accordance with the national legislation, and maintained in force following the accession of Austria to the European Economic Area, initially, and to the Community, subsequently, must be treated as an authorisation granted in accordance with Directive 65/65 for the purposes of applying Article 13 of Regulation No 1768/92."
Read the Opinion (in English) here.