The anti-HIV drug Truvada is a fixed-dose combination of the two active ingredients tenofovir disoproxil and emtricitabine. The patent of tenofovir disoproxil (EP 0 915 894 B1) expired at the end of July. Gilead’s Truvada SPC which is based on said patent covers the combination of tenofovir disoproxil and emtricitabine and does not expire until February 2020.
Four nullity actions have been filed against the Truvada SPC with the Federal Patent Court (4 Ni 12/17). The Truvada SPC has been challenged by all claimants for not complying with Article 3(a) of Regulation (EC) 469/2009, since in the claimants’ view, the combination of tenofovir disproxil and emtricitabine is not protected by the basic patent. At the beginning of August, the Federal Patent Court issued the qualified guidance order also considering the Truvada SPC as being invalid, since the combination of tenofovir and emtricitabine lacks protection by the basic patent. The oral hearing in the case on the merits will take place before the Federal Patent Court in May of next year.
An Isenbruck Bösl Hörschler team of our partners Fritz Lahrtz and Ulrike Herr is currently representing one of the pharmaceutical companies together with an attorney-at-law from the Munich office of an international law firm. They would be happy to answer any questions you may have.