Sandoz Ltd & Anor v G.D. Searle LLC & Anor

For Article 3(a) of the Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products, the product must be protected as such by the basic patent. Infringement alone is insufficient. The inquiry concerns the extent of the invention and the patent claims, interpreted under Article 69 of the European Patent Convention (EPC) and its Protocol, rather than infringement rules. The requirement that the claims relate to the product implicitly, necessarily and specifically creates uncertainty for broad Markush claims. Such a claim may sometimes identify a product sufficiently, but it is not automatically adequate regardless of its breadth or obscure substituents. The court referred to the CJEU whether immediate recognition from the claims and structure is enough, or whether the skilled person must derive the necessary substituents from common general knowledge.

The respondents owned an SPC for darunavir and the European patent relied on as its basic patent. The appellants sought to clear the way for marketing a generic product, contending that darunavir was not protected under Article 3(a) of the SPC Regulation. Arnold J held that darunavir was protected and declined to refer questions to the CJEU: [2017] EWHC 987 (Pat). The appeal concerned the application of the CJEU’s decisions in Medeva and Eli Lilly to a broad Markush claim containing no express reference to darunavir. The central issue was whether the compound was sufficiently identified by the claims, including whether the skilled person had to derive its specific substituents from common general knowledge at the priority date.

Disposition. The court stayed the appeal and proposed referring a question to the CJEU. Lord Justice Kitchin and Lord Justice Lewison agreed with Lord Justice Floyd’s judgment. The Court of Appeal did not finally determine the validity of the SPC.

1. Article 3(a) of the Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products requires the product covered by the SPC to be protected as such by the basic patent. The ordinary infringement question is insufficient because a claim to one active ingredient may be infringed by a combination containing that ingredient without the patent protecting the combination as such.
2. The applicable rules are those governing the extent of the invention under the relevant patent law. For a European patent, those rules include Article 69 of the European Patent Convention (EPC) and its Protocol. The infringement rules, including section 60 of the Patents Act 1977, are not the relevant test. The claims have a key role and are interpreted with the description.
3. The court treated the CJEU’s formulation in Eli Lilly as requiring the claims to relate to the active ingredient implicitly, necessarily and specifically. A structural formula is not essential. A functional definition may suffice if that requirement is met.
4. The application of that requirement to Markush claims remained uncertain. A Markush claim may be sufficiently precise where the substituents or classes of substituents can be identified by the skilled person. It does not follow that every Markush formula is sufficient, however broadly framed or obscure the relevant substituent. The court regarded it as arguable that the substituents must be identifiable from the patent and common general knowledge at the priority date.
5. The court considered that a better test might ask whether the product falls within the claim and embodies the core inventive technical advance of the patent. If that test were adopted, darunavir would satisfy it. The court nevertheless regarded the correct EU-law test as unclear and referred the issue for a preliminary ruling.

• Court of Appeal (Civil Division): stayed the appeal and proposed a reference to the CJEU.
• High Court of Justice, Chancery Division, Patents Court: Arnold J held that darunavir was protected by the basic patent and declined to refer questions to the CJEU: [2017] EWHC 987 (Pat).