Tenofovir & Emtricitabine - UK

On Jan 13, 2017, in his decision in “Teva UK Limited and Others v Gilead Sciences Inc” Arnold J has again referred a question to the CJEU concerning the interpretation of Article 3(a) of Regulation 469/2009 (the “SPC Regulation”) namely: what are the criteria for deciding whether a product (active ingredient or combination of active ingredients) is “protected” by a basic patent in force?

Teva, Accord, Lupin and Generics UK ltd commenced invalidity proceedings against one of Gilead’s SPCs. The SPC is for a composition containing tenofovir disoproxil with emtricitabine. Gilead’s combination product is TRUVADA® - an anti-retroviral used in treating HIV.

Gilead’s SPC relies on the marketing authorisation for Truvada and EP 0 915 894 (“the Patent”), claim 27 of which reads as follows:

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

Claimants argued that the case law is clear enough and no reference to the CJEU was needed and, in any event, emtricitabine is not “specified” in claim 27. Gilead in response argued that its SPC complies with the SPC Regulation as it is enough that its product falls within the scope of one of the basic patent’s claims using the “extent of protection” rules.

Arnold J decided that the infringement test for Art 3(a) had clearly been rejected but also came to the conclusion that “it is not sufficient for the product in question to fall within the scope of protection of the basic patent applying the Extent of Protection Rules. Something more is required”. His conclusion was therefore that “the test to be applied in order to determine whether a product is “protected” by a basic patent within the meaning of Article 3(a) remains unclear”, which necessitated a referral to the CJEU.