Gilead Sciences is battling the US government in court over a patent to prevent HIV

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The Gilead Sciences logo displayed on a laptop screen and medical pills are seen in this illustration photo taken in Krakow, Poland on October 18, 2021. (Photo by Jakub Porzycki/NurPhoto via Getty Images)

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Gilead Sciences and the US government faced off in court on Tuesday in the first day of a trial to investigate allegations that the drugmaker infringed on patents for a key HIV prevention drug scheme.

The US 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 raking in billions of dollars selling PrEP without paying royalties to the CDC.

The US filed suit against Gilead in 2019. Gilead has denied US allegations that the company infringes any CDC patents by selling its oral drugs PrEP, Truvada and Descovy.

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

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

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

“Gilead repeatedly refused to obtain a CDC license to use the patented regimens,” Justice Department attorneys wrote in the original complaint. “In effect, Gilead reaped billions from PrEP by selling Truvada and Descovy, but the CDC didn’t pay royalties.”

“Accordingly, Gilead knowingly and willfully caused CDC patent infringement and continues to do so,” the DOJ said.

Gilead rejects the CDC’s claims that the agency’s scientists developed the PrEP regimen. The company said it is not required to apply for a license from the CDC or pay licensing fees to the agency.

This two-drug PrEP regimen has been instrumental in reducing new HIV infections in communities at higher risk from the virus, such as men who have sex with men, after decades of failed vaccine development efforts.

Subsequent clinical trials have shown that PrEP is 99% effective in preventing HIV infection.

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