Tenofovir disoproxil & Emtricitabine - France

On May 25, 2018, the Paris Court of First Instance revoked the SPC on the combination of "tenofovir disoproxil & emtricitabine", marketed under trade name Truvada® by Gilead.

As per the decision summary reported on ‘SPC blog’, the Paris Court of First Instance held that "the patent on the basis of which the SPC 0032 was granted does not mention emtricitabine in the wording of its claims, neither makes it necessarily and specifically identifiable, nor does it mention a functional formula implicitly but necessarily and specifically.

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’.

Previously on Sep. 05, 2017 the High Court of Paris issued its decision on the validity of the Gilead SPC on Truvada® & denied injunction because of chances that SPC may be found invalid.

On similar line various courts have decided this issue:

On May 15, 2018, Federal Patent Court (FPC) of Germany revoked SPC to Gilead’s product, Truvada® in a validity proceeding challenged by generic filers.

On Apr. 25, 2018, in a request for a preliminary ruling, Advocate General Wathelet (UK) revoked the SPC.

On Oct. 26, 2017, the Danish Maritime and Commercial High Court issued a decision rejecting Gilead's motion for preliminary injunction against Accord Healthcare & found Gilead's Danish SPC for the combination invalid.

On Oct. 3, 2017, the Federal Patent Court of Switzerland rejected the application for annulment of SPC & held that it is only required by the law that the product is protected by a patent under fosinopril decision.