Gilead notches trial win in high-stakes HIV patent case against US government

It's extremely unusual for the U.S. government to go after a pharmaceutical company for alleged patent infringement, much less take the case to trial. But in the government's case against Gilead Sciences, the California drugmaker has come out on top.

After years of litigation, Gilead prevailed following the trial in a Delaware federal court. The jury found the patents at issue were invalid, The New York Times reports.

With that, the company doesn't have to pay the more than $1 billion that the government sought with its patent infringement case.

The company is "pleased" with the decision, Gilead’s executive vice president of corporate affairs and general counsel Deb Telman said in an emailed statement.

“Today’s decision confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP available to all who need it,” Telman said. “Gilead will continue to champion collaborations, including our efforts with the U.S. Health and Human Services Department (HHS) and CDC that span more than 15 years, as we all work together toward our common goal to end the HIV epidemic for everyone, everywhere.”

The case centers on Gilead’s HIV prevention drugs Truvada and Descovy, which the government argued infringed patents stemming from work at the Centers for Disease Control and Prevention (CDC).

The case dates all the way back to the mid-2000s, when Gilead and the CDC collaborated on research to determine whether the drugs could prevent HIV virus transmission in addition to treating the virus.

The U.S. then locked down four patents for the CDC’s work and offered Gilead licenses on the patents in exchange for a royalty, an offer the drugmaker rejected. That led to a 2019 lawsuit.

In 2020, the company shot back with a lawsuit against the U.S. government, claiming that it broke the terms of their partnership by obtaining the patents. Gilead won that case last year, when the U.S. Court of Federal Claims determined that the government did in fact violate three material transfer agreements.

Descovy pulled in $1.9 billion last year, while aging Truvada, which suffered a patent expiry in 2021, generated $147 million.