Last Friday, May 5, 2006, the ECJ gave its judgement in Massachusetts Institute of Technology (C-431/04) concerning SPC (supplementary protection certificates) and the meaning of "combination of active ingredients" in article 1(b) of EU Regulation 1768/92.
The ECJ did not follow the Opinion of Advocate-General Léger of on 24 November 2005.
The drug in question had two elements: an active ingredient, carmustine, and a polymeric, biodegradable excipient, polifeprosan. The national (German) courts held that no SPC could be granted for carmustine on its own since that active ingredient was already covered by a marketing authorisation and had been for a long time.
MIT had also requested that an SPC be granted for carmustine in combination with polifeprosan, arguing that the drug used the excipient as a necessary form of administration of the active ingredient in order to avoid toxic effect. Effectively, did use of this excipient together with the active ingredient amount to a combination of active ingredients? This was the issue referred to the ECJ by the German courts.
In a concise, 32 paragraph, judgment, the ECJ ruled that:
“Article 1(b) of Regulation 1768/92 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.”
This goes against A-G Léger's Opinion who advised that:
“The concept of “combination of active ingredients of a medicinal product” within the meaning of Article 1(b) of Regulation 1768/92 must be 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.”
The Questions Referred
The questions referred by the German Bundesgerichtshof were:
1. Does the concept of “combination of active ingredients of a medicinal product” within the meaning of Article 1(b) of Regulation [No 1768/92] mean that the components of the combination 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 a 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 implantation with controlled release of the active ingredient to avoid toxic effects)?