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The Gilead Sciences logo is displayed on a laptop screen and prescription pills in this illustration photo taken in Krakow, Poland on Oct. 18, 2021. (Photo by Jakub Porzycki/NurPhoto via Getty Images)
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Gilead Sciences The US government faced off in court on Tuesday on the first day of the trial, which will investigate allegations that the drugmaker infringed patents on a drug system important for HIV prevention.
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 making billions of dollars in sales of PrEP without paying royalties to the Centers for Disease Control and Prevention.
The United States filed the lawsuit against Gilead in 2019. Gilead has rejected US allegations that the company’s sales of the oral PrEP drugs, Truvada and Descovy, violate any CDC patents.
The trial in the federal district court of Delaware is expected to last six days.
Scientists at the CDC discovered in the mid-2000s that two drugs, emtricitabine and tenofovir, were highly effective in preventing HIV infection, according to a US government lawsuit.
Gilead Truvada and Descovy both contain emtricitabine and tenofovir. The company’s combined worldwide sales of Truvada and Descovy will be approximately $2 billion in 2022.
“Gilead has repeatedly refused to obtain a license from the Centers for Disease Control and Prevention to use the patented systems,” Justice Department attorneys wrote in the original complaint. “In fact, Gilead made billions in PrEP by selling Truvada and Descovy, but it never paid any royalties to the CDC.”
“Accordingly, Gilead willfully caused and continues to infringe CDC patents,” the Justice Department said.
Gilead rejects claims by the Centers for Disease Control and Prevention (CDC) that the agency’s scientists developed PrEP. The company said it is not obligated to apply for a license from the CDC or pay any royalties to the agency.
The two-drug PrEP regimen has played a major role 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 efforts to develop a vaccine.
Subsequent clinical trials have shown that PrEP is 99% effective in preventing HIV infection.
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