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".