Dutch Decision Invalidates Truvada SPC
Basic Patent Did Not Identify Emtricitabine
Gilead’s Truvada is not entitled to an SPC in the Netherlands because the patent on which the SPC application referred mentions only one of the two active ingredients in the combination antiretroviral.
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A supplementary protection certificate for Gilead’s Truvada combination antiviral is invalid because emtricitabine is not disclosed in the relevant patent, a UK appeals court has confirmed. But questions around the correct legal test remain unanswered.
Both steps of a test laid down by the Court of Justice for the European Union for invalidating supplementary protection certificates for combination products were satisfied by Mylan and Teva in an Irish dispute over protection for Gilead’s Truvada combination antiretroviral.
A court decision to invalidate Gilead’s UK supplementary protection certificate (SPC) on Truvada (tenofovir disoproxil/emtricitabine) is a “major first step in ensuring timely and appropriate generic competition” to the combination antiretroviral, as well as “a step forward in ensuring certainty and quality of the patent and SPC systems” in Europe, according to Medicines for Europe.