Tenofovir disoproxil & Emtricitabine - Germany

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.

As per the decision summary reported on ‘SPC blog’, the 4th Nullity Senate of the German Federal Patent Court nullified Gilead’s German SPC. Gilead’s holds German SPC DE 2005 000 0041.8, which had been granted for tenofovir disoproxil in combination with emtricitabine. 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’.

Generic filers specifically argued that emtricitabine is not implicitly, but necessarily and specifically mentioned in claim 27. The term ‘other therapeutic ingredients’ is very general & covers wide compound classes with different medicinal characteristics. The FPC decided that this term was insufficient to specify the active ingredient emtricitabine according to the criteria set by the Eli Lilly decision. Consequently, the requirements of Article 3(a) SPC-Regulation were not fulfilled for the product in dispute.

On similar line, on Apr. 25, 2018, Advocate General Wathelet (UK) also found that the combination (Tenofovir & Emtricitabine) SPC was not protected by same basic patent.