In a recent judgement (Sandoz Limited and G.D. Searle LLC  EWHC 987 (Pat)) the UK High Court has upheld the validity of an SPC where the specific compound for which marketing authorisation has been granted falls within the scope of a claim defining a class of alternative compounds (a so-called Markush claim), but is not itself specifically identified in the claims.
The validity of the SPC in question turned on the interpretation of Article 3(a) of the SPC Regulation (EC No. 469/2009), which requires that the product for which an SPC is sought is “protected by a basic patent in force”. In this decision, the High Court provided an analysis of what is meant by “protected by a basic patent” and held that Searle’s SPC granted for the anti-retroviral drug darunavir is valid despite the compound not being specifically identified in the claims of the patent on which the SPC is based.
The claimants (Sandoz and Hexal AG) sought to revoke the SPC held by Searle on the basis that the requirements of Article 3(a) of the SPC Regulation were not met. In particular, the claimants argued that the Markush formulation of the claims defined an extremely large number of alternative compounds and the skilled person would not have been able to specifically identify darunavir from the content of the application at the priority date. It was thus contended that darunavir could not be considered to be “protected by the basic patent”. In reply, the defendants (Searle and Janssen Sciences Ireland) submitted that darunavir falls within the scope of the Markush claim of the basic patent and, therefore, that darunavir is “protected” by the claims of the patent according to any tenable interpretation of the requirements of Article 3(a).
The High Court agreed with the defendants and held that the SPC met the requirements of Article 3(a) of the SPC Regulation. It was noted that the Court of Justice of the European Union (CJEU) held in the Medeva decision that Article 3(a) required the product to be “specified” or “identified” in the wording of the claims, but that the CJEU Lilly decision meant such identification in the claim did not need to be by means of a specific structural formula. It was also noted that the Lilly decision permitted the claim in question to cover a large number of other compounds in addition to the active ingredient in question. Following this analysis, the High Court held that an SPC for a product which is encompassed within a Markush claim of the basic patent but not specifically identified is able to meet the requirements of Article 3(a) of the SPC Regulation. As a result, the claimants’ claim for invalidity of the SPC was dismissed.
In the judgement, Mr Justice Arnold reiterated his comments from earlier judgements that the CJEU case law to date does not provide a clear test to determine whether the requirements of Article 3(a) have been met. He proposed that the relevant interpretation of Article 3(a) should be that the product is “protected” by the basic patent if: (i) the product falls within the scope of the claim; and (ii) the product does so because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the patent. This is a restatement of the test applied by Arnold J in relation to Article 3(c) of the SPC Regulation in Teva UK Ltd and Merck Sharp & Dohme Corp  EWHC 539 (Pat) (reported here).
The interpretation of Article 3(a) of the SPC Regulation remains contentious. Indeed, a recent referral to the CJEU by the UK High Court has again submitted the question “What are the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of the SPC Regulation?” (CJEU case C–121/17). We await the outcome of this referral for further guidance on how Article 3(a) should be interpreted.