U.S. sues Gilead, claiming it owns HIV PrEP patent

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The Department of Health and Human Services is suing Gilead Sciences over the patent rights to Truvada, the HIV prevention drug better known as PrEP.

That led Krellenstein and others to research the various patents that apply to the compounds, formulations and uses of these drugs for prevention purposes. “He was advocating very, very strongly because he was appalled about the price gouging that Gilead was doing with his invention and the massive barriers that caused for uptake,” Krellenstein said of the doctor who called him.

Christopher J. Morten, an NYU researcher and a lawyer for the PrEP4All Collaboration, said, “Gilead knew at least from 2008 that it was at risk of liability of patent infringement if it sold Truvada or Descovy as PrEP.” The lawsuit lays out a timeline that alleges Gilead contributed nothing more than donated Truvada tablets to multimillion-dollar human trials that were funded by the U.S. government and philanthropic donors.On Aug. 2, 2004, Gilead Sciences received FDA approval for Truvada as a drug to treat, not prevent, HIV. At the time, Truvada was considered one of the least toxic combination HIV-treatment tablets.

That is because, “in the mid-1990’s, high doses of subcutaneous tenofovir alone had been shown to have prophylactic activity in macaques exposed intravenously to simian immunodeficiency virus , a virus similar to HIV,”

 

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