Tenofovir & Emtricitabine – UK

On Apr. 25, 2018, in a request for a preliminary ruling, Advocate General Wathelet delivered judgment in SPC case involving Gilead’s Truvada (Tenofovir + Emtricitabine) product.

The High Court of Justice, Chancery Division (Patents Court), lodged this request for a preliminary ruling with the Court Registry on 8 March 2017. It concerned the interpretation of Article 3(a) of Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products. This request was made in proceedings brought by Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd and Generics (UK), trading as ‘Mylan’, against Gilead Sciences Inc. (‘Gilead’) contending that the SPC does not comply with Article 3(a) of that regulation. In the main proceedings, the applicants are challenging the validity of Gilead’s supplementary protection certificate (‘SPC’) SPC/GB05/041 for a product described in the SPC as a ‘composition containing both Tenofovir disoproxil (TD), optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine’. The product covered by the SPC is an anti-retroviral medication used in the treatment of human immunodeficiency virus (HIV) and is marketed by Gilead under the trade mark Truvada.

Gilead holds European patent No EP 0 915 894 (‘the basic patent’). This patent was expired on 24 July 2017. It covers, in general terms, a series of molecules, which are helpful in the therapeutic treatment of a number of viral infections in humans and animals, in particular HIV. Claim 27, which is important here, reads as:

 ‘A pharmaceutical composition comprising a compound according to any one of claims 1 to 25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients’.

The applicants in the main proceedings contended that claim 27 does not require the presence of any ‘other therapeutic ingredients’ since such ingredients are only ‘optionally’ present. Gilead asserted that in order for Article 3(a) of Regulation No 469/2009 to be satisfied, it is necessary and sufficient that the product in question falls within the scope of protection of at least one claim of the basic patent applying the Extent of Protection Rules. It takes the view that the combination of TD and emtricitabine does fall within the scope of protection of claim 27 of the patent under Article 69 of the EPC and under the Protocol on interpretation.

Court said the fact that a substance or combination of substances falls within the scope of protection of the basic patent is a necessary, but not sufficient, requirement for it to constitute a product protected by a patent within the meaning of Article 3(a) of Regulation No 469/2009. Court specifically held that the active ingredient emtricitabine is claimed solely through the use of completely indeterminate expressions such as ‘comprising’ and ‘optionally other therapeutic ingredients’, terms which may cover multiple substances that are not specifically and precisely identifiable on the priority date of the patent. Therefore, the combination containing the active ingredients TD and emtricitabine, that is to say, the medicinal product marketed under the name Truvada, is not protected by the basic patent within the meaning of Article 3(a) of Regulation No 469/2009, even though that combination may fall within the protection of claim 27 of the patent at issue in the main proceedings under Article 69 of the EPC.