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European Court of Justice rules against concept of combination of active ingredients

In a judgment of 4 May 2006, the European Court of Justice ruled against the concept of “combination of active ingredients”.

The German Federal Court of Justice (Bundesgerichtshof) had raised the question whether a supplementary protection certificate (SPC) could be granted for a product composed of an active ingredient (carmustine) and a slow release agent (polifeprosan).

The European Court of Justice has now decided that an SPC cannot be granted for such a combination, because the slow release agent is a substance which does not have any therapeutic effect of its own. It is therefore not seen as an “active ingredient”, which term is used to define the term “product” in the Council Regulation No 1768/92, governing the grant of SPC”s.

Interestingly, this ruling goes against the opinion of Advocate General Lëger of 24 November 2005. In his view the concept of “combination of active ingredients of a medicinal product” should have been interpreted as meaning that it does not preclude the grant of a supplementary protection certificate to a combination of two substances, one of which is a known substance with pharmacological properties of its own for a specific therapeutic indication and the other is necessary for the therapeutic efficacy of the first substance, for this indication.

For more information see: http://curia.eu.int (case C-431/04).