Gilead and the US are in a court docket battle over an HIV-prevention drug

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

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Gilead Sciences and the U.S. government faced Tuesday the first day of a trial in court investigating claims that the drugmaker violated patents on a key HIV-prevention drug.

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

The US filed the lawsuit against Gilead in 2019. Gilead has denied US allegations that the company’s sale of its oral PrEP drugs Truvada and Descovy infringes any CDC patents.

The trial in the Delaware District Court is expected to last six days.

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

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

“Gilead has repeatedly refused to obtain a license from CDC to use the patented therapies,” Justice Department attorneys wrote in the original complaint. “In fact, Gilead made billions from PrEP through the sale of Truvada and Descovy, but paid no royalties to CDC.”

“Accordingly, Gilead has willfully and willfully caused and continues to infringe CDC’s patents,” the DOJ said.

Gilead rejects claims by the CDC that agency scientists developed the PrEP regimen. The company said it has no obligation to apply for a license from the CDC or pay royalties to the agency.

“Not only did Gilead invent Truvada and Descovy, but the concept of using Truvada to prevent HIV was already known when the government tried to obtain its patents,” said a Gilead spokesman.

This two-drug regimen of PrEP has played a key role in reducing new HIV infections in communities that are at higher risk from the virus, such as those in the United States, after decades of failed efforts to develop a vaccine. B. Men who have sex with men.

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

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