Supplementary Protection Certficates

European practice

New proceedings initiated at the European Court of Justice

Case No C-202/05

05 March 2007

The preliminary ruling of the Court of Justice of the European Communities is requested on the interpretation of Article 1(b) of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (hereafter "the Regulation").
Reference has been made to the Court of Justice of the European Communities by order of the High Court of Justice (England and Wales), Chancery Division (Patents Court) of 20 December 2004, received at the Court Registry on 9 May 2005, for a preliminary ruling in the proceedings between Yissum Research and Development Company of the Hebrew University of Jerusalem and Comptroller-General of Patents.
The High Court of Justice (England and Wales), Chancery Division (Patents Court) has referred the following questions to the Court of Justice:
1. In a case in which the basic patent protects a second medical application of a therapeutic agent what is meant by "product" in Article 1 (b) of the Regulation and in particular does the application of the therapeutic agent play any part in the definition of "product" for the purpose of the Regulation?
2. Does the term "combination of active ingredients of a medicinal product" within the meaning of Article l(b) of the Regulation mean that each component of the combination must have therapeutic activity?
3. Is there a "combination of active ingredients of a medicinal product" where a combination of substances comprising two components of which one component is a substance with a therapeutic effect for a specific indication and the other component renders possible a form of the medicinal product that brings about efficacy of the medicinal product for that indication?