Gilead Sciences battles U.S. government in court over HIV prevention patent

Gilead Sciences and the U.S. government faced off in court Tuesday in the first day of a trial that will probe allegations that the drugmaker violated patents for a crucial HIV prevention drug regimen.

The U.S. is trying to enforce four patents issued to the Centers for Disease Control and Prevention on a two-drug regimen known as pre-exposure prophylaxis, or PrEP for short. The government accuses Gilead of reaping billions of dollars in PrEP sales without paying royalties to the CDC.

The U.S. filed the lawsuit against Gilead in 2019. Gilead has rejected U.S. allegations that the company’s sales of its PrEP oral medications, Truvada and Descovy, infringe on any CDC patents.

The trial in Delaware federal district court is expected to last six days.

Scientists at the CDC discovered in the mid-2000s that two drugs, emtricitabine and tenofovir, taken together were highly effective in preventing HIV infection, according to U.S. government’s lawsuit.

Gilead’s Truvada and Descovy both contain emtricitabine and tenofovir. The company’s combined sales worldwide for Truvada and Descovy were about $2 billion in 2022.

“Gilead has repeatedly refused to obtain a license from CDC to use the patented regimens,” Justice Department lawyers wrote in the original complaint. “Indeed, Gilead has reaped billions from PrEP through the sale of Truvada and Descovy, but has not paid any royalties to CDC.”

“Accordingly, Gilead has willfully and deliberately induced infringement of CDC’s patents and continues to do so,” the DOJ said.

Gilead rejects CDC claims that agency scientists developed the the PrEP regimen. The company said it’s not obligated to apply for a license with the CDC or pay the agency any royalties.

“Not only did Gilead invent Truvada and Descovy, but the concept of using Truvada to prevent HIV was well-known by the time the government tried to obtain its patents,” a Gilead spokesperson said.

This two-drug PrEP regimen has played a key part in reducing new HIV infections in communities that face a higher risk from the virus, such as men who have sex with men, after decades of failed efforts to develop a vaccine.

Subsequent clinical trials have demonstrated that PrEP is 99% effective at preventing HIV infection.