A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Sunday 6 March 2011

The Daiichi questions -- now on Curia

Another of the references for a preliminary ruling by the Patents Court (England and Wales) is now on the Curia website. This is Case C-6/11 Daiichi Sankyo Company v Comptroller-General of Patents (there's some background here and here on The SPC Blog).  The questions referred for rulings by the Court of Justice of the European Union are as follows:
1. Regulation 469/2009 (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 Art 3(a) of the Regulation and, if so, what are those further or different criteria? 
In order for a combination of active ingredients cited in an authorisation for placing a medicinal product on the market to be the subject of an SPC, and having regard to the wording to Article 4 of the Regulation, is the condition that the product be "protected by a basic patent" within the meaning of Articles 1 and 3 of the Regulation satisfied if the product infringes the basic patent under national law? 
In order for a combination of active ingredients cited in an authorisation for placing a medicinal product on the market to be the subject of an SPC, and having regard to the wording to Article 4 of the Regulation, does satisfaction of the condition that the product be "protected by a basic patent" within the meaning of Articles 1 and 3 of the Regulation depend upon whether the basic patent contains one (or more) claims which specifically mention a combination of (1) a class of compounds which includes one of the active ingredients in the said product and (2) a class of further active ingredients which may be unspecified but which includes the other active ingredient in the said product; or is it sufficient that the basic patent contains one (or more) claims which (1) claim a class of compounds which includes one of the active ingredients in the said product and (2) use specific language which as a matter of national law extends the scope of protection to include the presence of further other unspecified active ingredients including the other active ingredient in the said product?
The SPC Blog once again thanks the eagle-eyed Michèle Lavé (Cabinet Michèle Lavé) for letting us know.

No comments: