US Wants Another Shot at Gilead’s HIV-Prevention Drug Royalties

The US government, one week after a federal jury voided three of its patents for an HIV-prevention treatment, said it would renew its bid for judgments on a raft of disputed issues and seek a new trial over royalties from Gilead Sciences Inc.’s Truvada and Descovy.

The government intends to file a renewed motion for judgments on direct infringement and on the validity-related issues of anticipation, obviousness, and enablement, according to a joint status report filed Tuesday in the US District Court for the District of Delaware.

The move signals that any fog the case has brought to the research partnerships with the federal government on which the industry relies isn’t likely to dissipate anytime soon.

The US Health and Human Services Department sued Gilead and its Gilead Sciences Ireland UC subsidiary in November 2019, alleging that researchers at the Centers for Disease Control and Prevention in the mid-2000s developed the breakthrough approach for preventing HIV infections now known as pre-exposure prophylaxis, or PrEP.

A jury on May 9 voided the government-owned patents, which cover the two-drug PrEP regimen. It also found that Gilead’s Truvada and Descovy for PrEP wouldn’t have infringed the patents even if they were valid.

The government’s bid for a new trial also will include the issues of induced infringement, damages, the court’s exclusion of evidence from the jury trial regarding Gilead’s four petitions for administrative validity reviews, and the court’s “failure to exclude from the jury trial evidence related to the material transfer agreements and their intellectual property provisions.”

The US proposed a schedule that would have any post-trial motion and an opening brief totaling 30 pages due by June 6, with Gilead’s opposing brief due within 28 days of its filing. The government also asked for 15 pages to reply to Gilead’s response.

Gilead doesn’t plan to pursue “any further relief beyond denial” of the government’s motions. Though it said the existing page limits and local scheduling rules “are appropriate,” the company “does not oppose” the court’s consideration of the request.

The verdict marked a thorough success for Gilead and saved it from potentially having to pay as much as $1 billion in royalties. But Gilead’s victory has pharmaceutical industry insiders and healthcare advocates split on whether and how the fallout might affect such collaborations moving forward.

Lawrence Gostin, director of the World Health Organization Collaborating Center on National and Global Health Law, last week told Bloomberg Law the government’s loss means it “may very well go back to being highly deferential to Big Pharma, and gun-shy about going to court again.”

Hans Sauer, deputy general counsel for the Biotechnology Innovation Organization trade group, said that at this stage “it is neither clear nor likely that this dispute will significantly affect government-industry scientific collaboration.”

Wilmer Cutler Pickering Hale & Dorr LLP and Richards, Layton & Finger PA represent Gilead and Gilead Ireland. The Justice Department is representing the Health and Human Services Department.

The case is United States v. Gilead Sciences Inc., D. Del., No. 19-cv-2103, joint status report filed 5/16/23.