11.9.2010   

EN

Official Journal of the European Union

C 246/28

1.

Regulation 469/2009 (1) (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.

In a case like the present one involving a multi-disease vaccine, 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?

4.

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’?

5.

For the purposes of Article 3(a), is a multi-disease vaccine comprising multiple antigens ‘protected by a basic patent’ if all antigens directed against one disease are ‘protected by the basic patent in force’?

6.

Does the SPC Regulation and, in particular, Article 3(b); permit the grant of a Supplementary Protection Certificate for a single active ingredient or combination of active ingredients where: