Darunavir - UK

On May 03, 2017, Mr Justice Arnod of England and Wales High Court found SPC based on a Markush formula valid in Sandoz v Searle case.

In these proceedings the Claimant (Sandoz) challenge the validity of supplementary protection certificate SPC/GB07/038 ("the SPC") under Article 3(a) for a product described in the SPC as "Darunavir or the pharmaceutically acceptable salt, ester or prodrug thereof". The proprietor of the SPC is the First Defendant ("Searle") and the exclusive licensee is the Second Defendant ("JSI"). The SPC covers a product which is marketed in Europe by companies related to JSI under the trade mark Prezista. Prezista®is an anti-retroviral medication used in the treatment of human immunodeficiency virus (HIV). The Claimants seek to revoke the SPC, which expires on 23 February 2019 (including a paediatric extension of six months), in order to clear the way for the marketing of a generic darunavir product. The Claimants have admitted for the purpose of these proceedings only that, if the SPC is valid, then the marketing of their product prior to the expiry of the SPC would infringe it.

Article 3 of SPC regulation which relates to conditions for obtaining a certificate state that a certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application: (a) the product is protected by a basic patent in force. The interpretation of Article 3(a) has been the subject of a number of references to the CJEU from the English courts, the most recent of which arose in the case of Teva UK Ltd v Gilead Sciences Inc [2017] EWHC 13 (Pat) that is currently pending before the CJEU. 

The Patent, EP0810209 is entitled "Alpha- and beta-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors". The application was filed on 24 August 1993 with a claimed priority date of 25 August 1992. The Patent expired on 23 August 2013. Claim 1 is to a compound presented by Formula I. The claimants argued that darunavir was not "protected" by the claims of the patent because darunavir was not specifically identified by name or structure in the claims or in the specification, and because of the lack of any teaching in the patent pointing to darunavir. Claimants' objection is that claim 1 is of excessive breadth because it encompasses a vast number of compounds which the skilled person could not make even a tiny fraction of and which it is not plausible would all be efficacious as protease inhibitors (and the same goes for claims 2, 5, 10 and 11). This was despite the fact that it was agreed that darunavir fell within the Markush formulae of the claims. For the purposes of determining whether Markush claims complied with Article 3(a), the claimants had proposed a test which required determining whether the skilled person would consider the product to be part of the subject-matter of the patent based on their reading of the specification and their common general knowledge as at the priority date without undue burden or further invention.

Arnold J dismissed the claimants' test as unworkable and not in keeping with the "simple and transparent" system that had been envisaged by the European Commission before the SPC Regulation came into force. It is clear from this that the 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)." I cannot see that there is any tenable interpretation of Article 3(a) which leads to the conclusion that darunavir is not "protected" by the Patent. 

For the reasons given above, Arnold J concluded that the SPC complies with Article 3(a) of the SPC Regulation. Accordingly, the Claimants' claim is dismissed.