Case details
Summary
A national court may withdraw referred questions where a subsequent ruling of the Court of Justice has determined them. A reference should be maintained where the subsequent ruling does not resolve the remaining question and its interpretation is still necessary.
Here, the ruling in Massachusetts Institute of Technology was determinative of questions concerning combinations of active ingredients under Article 1(b) of the Regulation. Those questions were therefore withdrawn, while the separate question concerning the meaning of “product” was maintained.
Factual background
Yissum appealed against a decision of the Comptroller-General’s hearing officer refusing a supplementary protection certificate for a patent concerning compositions containing 1-alpha-hydroxycholecalciferol. The court had referred questions concerning the interpretation of Council Regulation 1768/92/EEC to the Court of Justice under Article 234 EC.
After the Court of Justice ruled in Massachusetts Institute of Technology, the parties agreed that two questions were no longer necessary. The issue was whether those questions should be withdrawn and whether the remaining question concerning the meaning of “product” should be maintained.
Held
- The reference was withdrawn in relation to questions 2 and 3. The ruling of the Court of Justice in Massachusetts Institute of Technology was determinative of those questions, which concerned the meaning of “combination of active ingredients of a medicinal product” under Article 1(b) of the Regulation. The parties agreed, and the court accepted, that no further ruling was required on them.
- The reference was maintained in relation to question 1. The subsequent ruling did not make the meaning of “product” in Article 1(b) sufficiently clear, particularly in a case involving a second medical application of a therapeutic agent. The court considered it necessary to obtain a ruling because different answers had been proposed in observations filed with the Court of Justice.
- The operative decision was therefore to withdraw questions 2 and 3 and maintain the reference on question 1.
The court’s approach to earlier authorities
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Appellate history
The judgment concerned an appeal by Yissum from the hearing officer’s decision dated 29 July 2004, reported as BL O/222/04. The court had previously made the reference by judgment dated 10 December 2004, [2004] EWHC 2880 (Pat).
Key cases cited
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