Jury clears Gilead in PrEP drug patent dispute with US government
09 May 2023
Drug ApprovalPatent Infringement
A US federal jury on Tuesday found that Gilead Sciences did not violate patents held by the Centers for Disease and Prevention (CDC) for a HIV prevention regimen, and voided three government-owned patents at the heart of the case. The verdict stems from a 2019 lawsuit filed by the Health and Human Services department accusing Gilead of profiting off CDC patents through the company's HIV-prevention regimen using Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide).
The decision in Delaware District Court "confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP (pre-exposure prophylaxis) available to all who need it," stated Gilead general counsel Deb Telman.
Government had sought $1 billion
Gilead collaborated with the CDC in the mid-2000s to test if Truvada could prevent transmission of HIV in addition to treating HIV infection. The FDA approved Gilead's Truvada for PrEP in 2012 and Descovy for PrEP in 2019, with the two products bringing in combined worldwide sales of about $2 billion last year. Descovy made up the bulk of that at $1.8 billion.
The US government argued that in the mid-2000s, the CDC had discovered that an approach combining emtricitabine and tenofovir was highly effective in preventing HIV infection. It sued Gilead for patent infringement in 2019, claiming the company "exaggerated" its role in developing PrEP, and "reaped billions" in sales without paying any royalty. The government was seeking up to $691 million in damages from Truvada for PrEP and $311 million from Descovy for PrEP.
Gilead denied the infringment accusations and argued the patents should be canceled. The Delaware jury on Tuesday agreed.
Meanwhile, a decision from the US Court of Federal Claims late last year, regarding a separate lawsuit, found that the US government had violated research agreements with Gilead by applying for PrEP patents without giving sufficient notice.
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