High Court refers questions to the ECJ on the creation of supplementary protection certificates for medicinal products

Proceedings in Yissum Research and Development Co of the Hebrew University of Jerusalem v Comptroller-General of Patents [2004] EWHC 2880 have been stayed pending the outcome of a reference to the ECJ.

Appeal

Yissum Research and Development Co ("Yissum") appealed against a ruling of the Comptroller-General, who had rejected Yissum's application for a supplementary protection certificate "SPC" in respect of a European patent. The Comptroller-General rejected the application on grounds that, in contravention of Article 3(d) of Regulation 1768/92 (the "Regulation"), marketing authorisations had previously been granted in respect of other medicinal products with the same sole active ingredient, calcitriol. He also rejected Yissum's alternative argument that the product was entitled to protection as a combination of calcitriol and an ointment base.

Questions referred to the ECJ

Richard Arnold QC concluded that Yissum's appeal raised questions of interpretation of the Regulation and referred two questions to the ECJ:

• whether "active ingredient" has to relate to the product protected by the basic patent and has to incorporate its application or use, and whether "product", for the purposes of Article 1(b) of the Regulation, refers to the active ingredient itself or to the medicinal products of which it is the sole active ingredient; and
• following the questions referred to the ECJ in Case 431/04, Massachusetts Institute of Technology's Application, whether "combination of active ingredients of a medicinal product" for the purposes of Article 1(b) of the Regulation, means that all components of the combination had to be active ingredients with a therapeutic effect, or whether a combination of two substances comprising two components, of which one was a known substance with a specific indication and the other rendered possible a pharmaceutical form of the product which brought about a changed efficacy of the product for that indication, constituted a "combination of active ingredients of a medicinal product".