US government appeals Gilead's trial win in Truvada, Descovy patent fight

As Gilead Sciences tussles with a web of HIV drug litigation, a high-stakes case tied to patents for prevention medicines is coming back to test the drugmaker.

On Friday, the U.S. Department of Justice appealed Gilead’s May 2023 victory in a Delaware court, which found that use of Gilead's pre-exposure prophylaxis (PrEP) regimens did not infringe three key patents the U.S. has credited to the CDC.

The federal jury further ruled that the patents were invalid due to obviousness, letting Gilead avoid paying the $1 billion the government was seeking in its infringement case.

The latest challenge to Gilead’s PrEP patents comes after the Delaware federal court in March granted the government's motion to dispute the jury’s findings.

Gilead, for its part, stood by the earlier jury decision and said it's proud to have developed Truvada and Descovy, a company spokesperson told Fierce Pharna. 

"Gilead will continue to champion collaborations, including our efforts with the U.S. Health and Human Services Department 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," she added.

It’s unusual for the U.S. government to challenge a company over alleged patent infringement, much less take the case to trial. Gilead’s PrEP imbroglio dates back to the mid-2000s, when Gilead and the CDC teamed up on research to determine whether HIV treatments could help prevent virus transmission.

The U.S. ultimately locked down several patents stemming from the CDC work and offered Gilead licenses to the patents in exchange for a royalty. But when the drugmaker refused that offer, a 2019 lawsuit from the government ensued.

The PrEP back-and-forth comes as Gilead wrangles other, unrelated HIV litigation.

Last month, for instance, Gilead proposed a $40 million settlement to resolve claims from more than 2,000 plaintiffs that the company intentionally delayed the introduction of newer and safer HIV meds.

At the time, Gilead said the one-time payment was meant to avoid the cost and distraction of litigation. The company stressed that the proposed settlement was “in no way” an admission of wrongdoing or liability.

Separately, Gilead is awaiting a decision this month in similar yet separate state litigation in the California Supreme Court, which also centers around claims Gilead delayed the rollout of newer HIV treatments to maintain profits on older drugs.

For all of 2023, Truvada—which the FDA approved for HIV prevention in 2012—generated $114 million. Newer drug Descovy, which scored its U.S. PrEP greenlight in 2019, brought home nearly $2 billion.

Editor's note: This story has been updated with comments from Gilead Sciences.