Supplementary Protection Certficates

European practice

Case No C-431/04 (Massachusetts Institute of Technology)

On 7 October 2004 the Bundesgerichtshof (Federal Court of Justice, Germany) filed a request with the European Court of Justice for a preliminary ruling in order to interpret 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 (hereinafter: the Regulation).
The Bundesgerichtshof has referred the following questions to the Court of Justice:
1) Does the term "combination of active ingredients of a medicinal product" within the meaning of Article 1(b) of the Regulation mean that the components of the combinations must all be active ingredients with a therapeutic effect?
2) Is there a "combination of active ingredients of a medicinal product" also where a combination of substances comprises two components of which one component is a known substance with therapeutic effect for a specific indication and the other component renders possible a pharmaceutical form of the medicinal product that brings about a changed efficacy of the medicinal product for this indication (in-vivo transplantation with controlled release of the active ingredient to avoid toxic effects)?
The European Court of Justice has published his judgement on 4 May 2006. The Court rules as follows: Article 1(b) of the Regulation must be interpreted so as not to include in the concept of 'combination of active ingredients of a medicinal product' a combination of two substances, only one of which has therapeutic effects of its own for a specific indication, the other rendering possible a pharmaceutical form of the medicinal product which is necessary for the therapeutic efficacy of the first substance for that indication.
The Case No C-431/04