By Blake Brittain
(Reuters) – A federal jury on Tuesday found that Gilead Sciences Inc did not infringe U.S. patents with its HIV-prevention regimen using the drugs Truvada and Descovy, handing the government a defeat in its billion-dollar lawsuit.
The Delaware jury found the government’s patents were invalid and not infringed.
The federal government had argued that Gilead failed to compensate the U.S. Centers for Disease Control and Prevention (CDC) for discovering that its drug Truvada, which was first approved to treat HIV, could also help prevent infection by the virus.
The lawsuit appears to mark the first time the U.S. government sued a drugmaker to enforce its patent rights.
The government said in a court filing it was entitled to up to $691 million in damages from Truvada for PrEP (pre-exposure prophylaxis) and $311 million from Descovy for PrEP.
Gilead general counsel Deb Telman said on Tuesday that the company was pleased with the verdict, which “confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP available to all who need it.”
Foster City, California-based Gilead collaborated with the CDC in the mid-2000s to test if Truvada could prevent transmission of the virus that causes AIDS in addition to treating it.
The government obtained multiple patents for HIV prevention drug regimens it says CDC researchers developed. It said at the trial that three of the patents also cover Gilead’s pre-exposure prophylaxis regimen for lowering HIV infection risk.
The U.S. Food and Drug Administration approved Gilead’s Truvada for PrEP in 2012 and its related drug Descovy for PrEP in 2019.
Gilead reported worldwide sales of more than $2 billion last year from Truvada and Descovy.
Descovy, with $1.8 billion in 2022 sales, was Gilead’s fourth-best selling product behind the HIV drugs Biktarvy and Genvoya and COVID-19 treatment Veklury (remdesivir).
The federal government sued Gilead for patent infringement in 2019, claiming the company “exaggerated” its role in developing PrEP, ignored the CDC’s contributions and refused to license the CDC’s patents.
Another court decided in a separate lawsuit last year that the government breached research agreements with Gilead by applying for the patents without giving sufficient notice.
(Reporting by Blake Brittain in Washington; Editing by David Bario and Bill Berkrot)
