Gilead Sciences, US square off in billion-dollar HIV drug patent trial

The U.S. Food and Drug Administration approved Gilead's Truvada for HIV prevention in 2012 and approved its related drug Descovy for the same purpose in 2019.

Gilead made more than $2 billion last year from worldwide sales of Truvada and Descovy, according to a company report. Descovy, which earned Gilead over $1.8 billion last year, is its fourth-best selling drug behind the HIV drugs Biktarvy and Genvoya and COVID-19 treatment Veklury.

The federal government sued Gilead for patent infringement in 2019, claiming Gilead "exaggerated" its role in developing PrEP, ignored the CDC's contributions and refused to license the CDC's patents.

Gilead has denied the allegations and argued the patents are invalid. In parallel to the jury trial, Delaware U.S. District Judge Maryellen Noreika will separately consider Gilead's argument that the patents are unenforceable based on government misconduct.

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.

The damages in that case have not yet been determined but could offset any award the government wins in the infringement lawsuit.