Lawsuit filed against Gilead Sciences for HIV/AIDS drug tenofovir
AIDS Healthcare Foundation (AHF) filed a federal lawsuit against Gilead Sciences Inc. seeking to invalidate patents on key AIDS drug tenofovir. Tenofovir is a component in Genvoya, Gilead’s four-in-one Fixed Dose Combination (FDC) to treat HIV/AIDS patients as well as Gilead’s similar predecessor FDC, Stribild.
The lawsuit asserts that TAF, a prodrug of the compound tenofovir, is not a new compound, and is using a preexisting patent licensing agreement with Emory University to block entry by potential competitors and prevent competition.
Comment: In January 2013, shortly after the FDA approved Stribild, the Fixed Dose Combination that Genvoya is now based on, Gilead filed a citizen’s petition with the FDA seeking an extension on its patent protection on Stribild from three years to five years. In October 2014, the FDA denied Gilead’s petition for the patent extension.
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