Drug companies often have disagreements about the patents behind lucrative medicines, but it's highly unusual for the U.S. to take a top pharmaceutical company all the way to a trial. In the case over Gilead Sciences' PrEP drugs, that's exactly what's happening.
Jury selection begins today in the U.S.' patent case against Gilead in Delaware federal court, according to a judge's order from late last week. The sides will present their cases at both a jury trial and at a bench trial, according to the order. In a bench trial, lawyers argue in front of a judge rather than a jury.
The case centers on Gilead's HIV prevention drug Truvada, which is now off patent, and its successor Descovy. Back in 2019, the U.S. government sued Gilead after the company allegedly balked at licensing U.S.-owned patents.
In the 2019 lawsuit, the U.S. said Gilead benefited from hundreds of millions of dollars in taxpayer-funded research. At the time, then-secretary of the Department of Health and Human Services (HHS) Alex Azar said the company “must respect the U.S. patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs.”
In the early 2000s, Centers for Disease Control and Prevention researchers developed two-drug regimens that can prevent HIV infection, according to the government's lawsuit. The U.S. scored four patents on the work. The U.S. then sought to license those patents to Gilead in exchange for a royalty, but the California-based drugmaker refused, HHS said.
Gilead, for its part, "strongly" believed the patents were invalid, the company said at the time. In 2020, the company filed its own lawsuit claiming the government violated the terms of their partnership by seeking the patents in the first place.
That tactic paid off. Late last year, the company scored a win in its own case, with the U.S. Court of Federal Claims ruling that the government violated three so-called material transfer agreements. Damages in that case have not yet been awarded.
Now, the government's case is heading to trial after years of court proceedings. The government is seeking more than $1 billion from Gilead, Reuters reports.
Gilead generated (PDF) $1.87 billion in worldwide sales from Descovy last year. Truvada, facing U.S. generic competition, pulled down $147 million.