The US Government was slapped down by a federal jury on Tuesday which found that Gilead Sciences did not infringe US patents with its HIV-prevention regimens using the drugs Truvada and Descovy, and declaring the government’s patents invalid.
The government had argued that Gilead failed to compensate the US Centres 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.
Reuters reports that the lawsuit appears to mark the first time the government has sued a drugmaker to enforce its patent rights.
The government had claimed it was entitled to up to $691m in damages from Truvada for PrEP (pre-exposure prophylaxis) and $311m from Descovy for PrEP.
Gilead had 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 that 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 FDA approved Truvada for PrEP in 2012 and the related drug Descovy for PrEP in 2019. Gilead reported worldwide sales of more than $2bn last year from the two.
The government sued Gilead for patent infringement in 2019, claiming it “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.
See more from MedicalBrief archives:
‘Malicious’ Gilead vs US in mega HIV drug patent trial
US Health department sues Gilead Sciences over Truvada patent rights
Gilead accused of anti-competitive deals to block ARV generics