Yissum Research and Development Company of the Hebrew University of Jerusalem v Comptroller-General of Patents

The court referred questions concerning the meaning of Council Regulation 1768/92/EEC rather than deciding whether the proposed supplementary protection certificate should be granted. The term “product” in Article 1(b), and the related concept of active ingredients, raised questions not answered with sufficient certainty by existing authority. Where a related reference is already pending before the Court of Justice and the domestic issue is not acte clair, it is appropriate to make a further reference.

Yissum appealed against the hearing officer’s refusal of its application for a supplementary protection certificate for calcitriol under Council Regulation 1768/92/EEC. The application identified calcitriol as the product and relied on a marketing authorisation for Silkis ointment. It alternatively sought to identify the product as calcitriol combined with an ointment base.

The hearing officer considered that earlier marketing authorisations for calcitriol meant that the Article 3(d) condition was not met, and rejected the argument that the ointment base was an active ingredient. The central issues were the meaning of “product” and “combination of active ingredients” under Article 1(b), and whether the questions were acte clair in light of a pending reference.

The court did not finally determine entitlement to a supplementary protection certificate. It decided to refer questions to the Court of Justice concerning both Yissum’s primary and alternative cases.

1. The alternative case raised whether a combination of calcitriol and an ointment base could constitute a “combination of active ingredients” under Article 1(b) of Council Regulation 1768/92/EEC. The pending reference in Case 431/04 Massachusetts Institute of Technology’s Application asked a directly relevant question concerning whether all components must themselves have a therapeutic effect.

2. The primary case raised whether “product” could be defined by reference to calcitriol for a particular therapeutic use. The judge considered that the answer was not acte clair. Case C-31/03 Pharmacia Italia SpA’s Application did not resolve the issue because it concerned human and veterinary uses rather than a second medical use.

3. Following Case 283/81 CILFIT Srl v Ministry of Health, the acte clair test required certainty both as to the answer and as to the likelihood that other Community courts and the Court of Justice would adopt the same answer.

4. Although the court was not one of last resort and retained a discretion whether to refer, the existence and relevance of the MIT reference made a reference appropriate. Counsel were to be heard on the precise form of the questions.

• High Court (Patents Court): Appeal from the hearing officer’s decision dated 29 July 2004 (BL O/222/04). The substantive issues were not finally determined and questions were to be referred to the Court of Justice.