1. Regulation 469/20091 (the Regulation) recognises amongst the other purposes identified in the recitals, the need for the grant of an SPC by each of the Member States of the Community to holders of national or European patents to be under the same conditions, as indicated in recitals 7 and 8. In the absence of Community harmonisation of patent law, what is meant in Article 3(a) of the Regulation by "the product is protected by a basic patent in force" and what are the criteria for deciding this?
2. In a case like the present one involving a medicinal product comprising more than one active ingredient, are there further or different criteria for determining whether or not "the product is protected by a basic patent" according to Article 3(a) of the Regulation and, if so, what are those further or different criteria?
3. Is one of these further or different criteria whether the active ingredients are admixed together rather than being delivered in separate formulations but at the same time?For the purposes of Article 3(a), is a multi-disease vaccine comprising multiple antigens "protected by a basic patent" if one antigen of the vaccine is "protected by the basic patent in force"?
4. In a case like the present one involving a medicinal product comprising more than one active ingredient, is it relevant to the assessment of whether or not "the product is protected by a basic patent" according to Article 3(a) that the basic patent is one of a family of patents based on the same original patent application and comprising a parent patent and two divisional patents which between them protect all the active ingredients in the medicinal product?
5. In a case like the present one involving a basic patent with claims to "a process to obtain a product" in the sense of Article l(c), does the "product" of Article 3(a) have to be obtained directly by means of that process?
6. Does the SPC Regulation and, in particular, Article 3(b), permit the grant of a Supplementary Protection Certificate for a single active ingredient where:
a basic patent in force protects the single active ingredient within the meaning of Article 3(a) of the SPC Regulation; and
a medicinal product containing the single active ingredient together with one or more other active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC2 or 2001/82/EC3 which is the first marketing authorization that places the single active ingredient on the market?
7. Does the answer to Question 7 differ depending on whether the authorisation is for the single active ingredient admixed with the one or more other active ingredients rather than being delivered in separate formulations but at the same time?
____________1 - Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version) (Text with EEA relevance ) OJ L 152, p. 12 - Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use OJ L 311, p. 67