On 3 May 2017, Mr Justice Arnold handed down his decision in Sandoz v Searle  EWHC 987 (Pat). The case related to a nullity action brought by Sandoz and Hexal in relation to SPC/GB07/038, which is owned by Searle and exclusively licensed to Janssen Sciences Ireland (the co-Defendant). The product underlying the SPC is darunavir, an anti-retroviral protease inhibitor marketed as Prezista. In summary, the Claimants’ case was that darunavir is not specified or identified in any of the claims of the basic patent and is not therefore “protected by” that patent for the purposes of Article 3(a) of the SPC Regulation (Regulation (EC) No 469/2009). In this regard, both sides were agreed that there is no specific reference to darunavir anywhere in the specification. However, and importantly, the claims of the basic patent include markush formulae which cover darunavir if the appropriate selections are made. The key issue to be decided was therefore whether a compound could be sufficiently specified/identified in the wording of the claims for Art 3(a) purposes if the compound was not specified/identified in the patent other than as one member of a large class of compounds disclosed within a markush formula.
In a positive decision for innovative pharmaceutical companies, Arnold J found in favour of the Defendants and upheld the SPC (he helpfully summarises both sides’ arguments and his analysis at paragraphs 58-68). In doing so, he focused on Lilly v HGS (C-493/12), where the CJEU stated that it is not necessary for Art 3(a) purposes for an active ingredient to be identified in a claim by means of a structural formula. Arnold J’s view was that the Lilly decision made it clear that “identification of the active ingredient in the claim by means of a structural formula is permissible, but not essential; that it is not necessary for the claim individually to name or depict the active ingredient; and that it is not necessarily an objection that the claim in question covers a large number of other compounds in addition to the active ingredient in question (since, if that was so, it would have provided a simple answer to the Lilly case)” (see paragraph 63). As a result, Arnold J concluded that it is sufficient for Art 3(a) purposes for a basic patent’s claim to specify an active ingredient by means of a markush formula which covers it.
The question surrounding whether markush claims would be sufficient for Art 3(a) purposes has been troubling those interested in SPCs for some time. Indeed, Arnold J himself mentioned the issue at paragraph 53 of the Novartis v MedImmune  EWHC 181 (Pat) case back in 2012. In light of the policy behind the SPC Regulation and the fact that markush claims are a common way to claim compounds, this clear decision from Arnold J, a judge with vast SPC experience, is very welcome. Additionally, it is worth noting that this decision has come at a time when Arnold J’s reference to the CJEU in Teva v Gilead  EWHC 13 (Pat), which relates to the appropriate test to be applied when considering Art 3(a), is pending. Whilst that case relates to a combination product, the question referred by him on the Art 3(a) test is not limited to such products and, interestingly, it is clear from paragraph 65 of the Sandoz judgment that Arnold J’s view is that the test he proposed in Teva v Gilead should also be considered for use in single active ingredient cases.