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Friday 5 May 2017

Darunavir and the interpretation of Article 3(a) by Mr Justice Arnold

Earlier this week, Mr Justice Arnold handed down a decision (here, [2017] EWHC 987 (Pat)) relating to the validity of Searle’s SPC to darunavir  in view of Article 3(a) of the SPC Regulation.

The facts of the case are as follows: G.D. Searle LLC hold SPC/GB07/038 (“the SPC”) to darunavir.  Janssen Sciences Ireland UC is the exclusive licensee. The SPC is based on EP 0 810 209, to which claim 1 is directed to a compound presented by Formula I

wherein the substituents P1, P2, R2, R3, and R4 are listed.

Sandoz and Hexal challenged the validity of the SPC on the basis that it does not comply with Article 3(a) of the SPC Regulation because darunavir is not specified or identified in any of the claims of the patent.  In particular, they argued that although darunavir falls within the scope of the claims, it is not specifically identified by name or structure in the claims or in the specification, nor is there any teaching in the patent which points to darunavir.

After briefly reviewing the CJEU’s  “guidance” in the Medeva and Lilly cases in relation to whether a product satisfies the requirement of Article 3(a) of the SPC regulation, Mr Justice Arnold came to the conclusion that it is sufficient for the claim to specify the product by means of a Markush formula which covers it.  Not entirely happy with the CJEU’s unclear tests, he also referred to what he considered as a better test, and as he advanced in Teva v Gilead, which would require that the product falls within the claim and that it embodies the inventive advance (or technical contribution) of the claim.

Kristina Cornish and Dayle Callaghan of Kilburn & Strode LLP were part of the team acting for the defendant in this successful matter.