Astellas Pharma Inc v Comptroller-General of Patents

For Article 3(a) of the Council Regulation 1768/92/EEC, the relevant question is which active ingredients of a combination product are protected by the claims of the basic patent. A combination is not protected merely because it would infringe a patent protecting one of its ingredients. The court followed the approach that the ingredient which brings the combination within the claim is the protected product. A patent claim may cover a product without disclosing it, but coverage alone does not establish that the combination itself is protected. Where the marketing authorisation is for a combination, an applicant cannot amend the application to obtain an SPC for one ingredient unless the authorisation is also for that ingredient. The appeal was dismissed.

Astellas appealed from the decision of a hearing officer, Dr Lawrence Cullen, refusing an application for a supplementary protection certificate under the Council Regulation 1768/92/EEC. The application concerned Profender, a veterinary product containing emodepside and praziquantel. The basic patent claimed emodepside but did not disclose or claim praziquantel or the combination.

The appeal raised whether the patent protected the combination for Article 3(a), whether the infringement test should replace the approach in Takeda Chemical Industries Ltd’s SPC Applications (No 3), and whether Astellas could amend the application to seek an SPC for emodepside alone.

The appeal was dismissed. The hearing officer had correctly refused the SPC application.

1. Article 3(a) requires identification of the active ingredients relevant to whether the product falls within the scope of a claim of the basic patent. Where a combination contains ingredients A and B, and the patent claims A alone, A is protected, but the combination A plus B is not protected as such. This was the test articulated in Gilead Sciences Inc’s SPC Application at [2008] EWHC 1902 (Pat) [33].
2. Claim 19 used “comprises” in its usual inclusive sense and therefore covered products containing substances in addition to the claimed compound. It did not follow that the claim disclosed a combination of the claimed compound with another active ingredient. A claim may cover a product without disclosing it, as recognised in A.C. Edwards Ltd v Acme Signs & Displays Ltd [1992] RPC 131.
3. Although Profender was covered by claim 19, emodepside alone was what brought the product within the claim. Praziquantel and the excipient BHA did no such work. Profender was therefore not protected by the basic patent within Article 3(a).
4. The court was not persuaded that Takeda Chemical Industries Ltd’s SPC Applications (No 3) was wrong. The distinction between the scope of patent protection and infringement remained material. The arguments identified in Gilead Sciences Inc’s SPC Application justified consideration by a higher court, and possibly the Court of Justice, but the referral decision was left to the Court of Appeal.
5. An amendment seeking an SPC for emodepside alone would fail Article 3(b), because the marketing authorisation was for Profender and not for emodepside as a separate product. The court relied on Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd [2009] EWCA Civ 646 at [57]–[58].

1. High Court (Patents Court): the appeal from the hearing officer’s decision was dismissed.
2. Hearing officer: Dr Lawrence Cullen refused application SPC/GB/06/002 in decision BL O/052/09 dated 20 February 2009.