Medeva's SPC Applications, Re (Rev 1)

For a supplementary protection certificate involving a combination medicinal product, the meaning of product protected by a basic patent under the Council Regulation (EC) No 469/2009 and the relationship between the product and its marketing authorisation require authoritative interpretation where unresolved. An earlier Court of Justice decision concerning different pharmaceutical forms does not necessarily answer whether a combination is protected when only some active ingredients are claimed. The absence of harmonised European patent law, recurring issues and divergent national approaches may make a reference necessary. Under Article 267 TFEU, the appellate court must refer where the answer is necessary to enable it to give judgment.

Medeva appealed against the rejection of five applications for supplementary protection certificates. Its patent concerned a vaccine method using pertactin and filamentous haemagglutinin, while the marketing authorisations covered combination vaccines for several diseases. The Comptroller concluded that four applications failed under Article 3(a) because the products contained additional active ingredients, and that the fifth failed under Article 3(b) because its authorisation covered a wider combination. Kitchin J upheld that decision in [2010] EWHC 68 (Pat). On further appeal, the Court of Appeal considered whether the infringement test applied, whether multi-disease vaccines required special treatment, whether protection of only part of a vaccine was sufficient, and whether an authorisation for a wider combination could satisfy Article 3(b).

The Court of Appeal did not determine whether any of the applications satisfied the Regulation. It made a preliminary reference to the Court of Justice of the European Union and stayed the appeal.

1. Reference threshold. Under Article 267 TFEU, a reference is appropriate where a decision on the question is necessary to enable the appellate court to give judgment. That threshold was amply satisfied. There was substantial doubt about the effect of existing authority, divergence or uncertainty between national approaches, and repeated emergence of the same or similar issues.
2. Article 3(a). The Court of Justice decision in Farmitalia, Case C-392/97, had held that an SPC could cover a product in forms enjoying the protection of the basic patent and that the relevant protection was determined by the rules governing that patent. The Court of Appeal considered that the decision did not clearly address the materially different problem of a medicinal product combining active ingredients where only some were claimed. It also raised a real question whether European law permitted the product to be identified simply by reference to any product whose sale could be restrained under national infringement law. The absence of European harmonisation suggested that the concept might require an autonomous European meaning.
3. Combination vaccines. No decision of the Court of Justice had determined whether multi-disease vaccines required different criteria, or whether protection of one antigen or all antigens directed against one disease was sufficient under Article 3(a). The Court therefore referred those questions without deciding them.
4. Article 3(b). It was also unresolved whether an SPC could be granted for a patented ingredient or combination where the first valid authorisation covered that ingredient or combination together with additional active ingredients. The necessary relationship between the product, the authorisation and the medicinal product required clarification.
5. Order. The questions set out in the Schedule to the order were referred under Article 267 TFEU. Further proceedings in the appeal were stayed, the reference was directed to be transmitted under CPR Part 68, costs were reserved and liberty to apply was granted.

• Court of Appeal (Civil Division): The Court referred questions concerning Articles 3(a) and 3(b) of the Council Regulation (EC) No 469/2009 to the Court of Justice of the European Union and stayed the appeal.
• Chancery Division (Patents Court): Kitchin J dismissed Medeva’s appeal and upheld the Comptroller’s decision in [2010] EWHC 68 (Pat).
• Comptroller General of Patents: On 16 November 2009, the five SPC applications were rejected.