Re Council Regulation (EEC) No 1768/92

For the purposes of Article 3(a), a product is protected by a basic patent if it falls within the scope of a patent claim, interpreted under the applicable national patent law. For a product comprising active ingredients A and B, a patent claiming only A protects A, not the combination as such. A claim directed to a composition comprising A together with other active ingredients may, however, protect the combination where both ingredients bring it within the claim. The court should not impose an additional requirement of a clear pointer, specific disclosure, inventiveness or research effort.

Gilead Sciences, Inc appealed against the decision of the Comptroller of Patents, dated 10 January 2008, refusing its application for a supplementary protection certificate for a medicinal product containing tenofovir disoproxil and emtricitabine.

The dispute concerned Article 3(a) of Council Regulation (EEC) No 1768/92. The central question was whether the combination was protected by the basic patent, particularly claim 27, which covered a pharmaceutical composition comprising a claimed compound and optionally other therapeutic ingredients.

1. Appeal allowed. The combination of tenofovir and emtricitabine was protected by claim 27 of the basic patent within Articles 1(c) and 3(a) of the Regulation.
2. The court considered the approach in Takeda Chemical Industries Ltd’s SPC Applications (No.3) [2004] RPC 1. The relevant inquiry was to identify the active ingredients which were relevant to whether the product fell within the scope of a claim. Those ingredients, and only those ingredients, were protected within the meaning of the Regulation. Thus, a patent claiming A protected A, rather than a combination of A and B.
3. Claims 1 and 25 covered tenofovir, but the combination fell within those claims only because tenofovir was present. Claim 27 was materially different. It was directed to a composition comprising tenofovir together with a carrier and optionally other active ingredients. The combination fell within that claim because both tenofovir and emtricitabine were relevant to the claimed combination.
4. The proposed clear-pointer or specific-disclosure test had no sufficient foundation in the Regulation or the Patents Act 1977. There was no requirement that the particular ingredient be specifically disclosed or expressly supported in the body of the specification. Nor was it appropriate to investigate whether the claim was inventive, obvious or supported by significant research effort.
5. The court regarded the broader question whether the infringement approach or the Takeda approach was correct as difficult and potentially suitable for consideration by a higher court or the Court of Justice. It was unnecessary to decide that question because the combination was protected under either approach.
6. The SPC would be limited to the combination of tenofovir and emtricitabine. It would not extend to tenofovir alone or to any other use.

• High Court (Patents Court): On appeal from the Comptroller of Patents’ decision dated 10 January 2008, reported as BL 0/006/08, the appeal was allowed.