Gilead SPC decision on Truvada 'leads to successful clarification in English court'

This week’s verdict from Britain’s  High Court on Gilead Sciences’ (Nasdaq: GILD) antiretroviral product Truvada (emtricitabine/tenofovir) has been welcomed by Medicines for Europe, the trade group representing generic and biosimilar drugmakers.

The High Court has determined that the contested supplementary protection certificate (SPC) on Truvada held by Gilead is invalid by applying the criteria laid down by a recent referral to the Court of Justice of the European Union (CJEU). Mr Justice Arnold held that Gilead’s SPC failed the CJEU’s test as Gilead’s basic patent on which the SPC was based did not describe the combination of tenofovir and emtricitabine and did not specifically identify emtricitabine.

This judgment applying the CJEU decision should now assist in the resolution of a number of parallel cases in national courts across Europe.