A Gilead Sciences logo and medical pills are seen on a laptop screen 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 on Tuesday, the US government faced off in court on the first day of a trial investigating allegations that a pharmaceutical company had infringed a patent on a key HIV-prevention drug regimen.
The United States is seeking 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 from selling his PrEP without paying royalties to his CDC.
The United States filed a lawsuit against Gilead in 2019. Gilead has rejected US allegations that the company’s marketing of his PrEP oral drugs, Truvada and Desicovy, infringes his CDC patents.
The trial in the U.S. District Court for Delaware is scheduled to last six days.
CDC scientists 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’s Truvada and Desicovy both contain emtricitabine and tenofovir. In 2022, he had approximately $2 billion in combined worldwide sales for Truvada and Deskovy.
“Gilead has repeatedly refused to obtain a license from the CDC to use its patented regimen,” Justice Department attorneys wrote in the original complaint. “In fact, Gilead has made billions of dollars from PrEP through sales of Truvada and Desicovy, but does not pay royalties to the CDC.”
“Therefore, Gilead knowingly induces infringement of the CDC’s patents and will continue to do so,” DOJ said.
Gilead rejects CDC’s claims that agency scientists developed the PrEP regimen. The company said it is not obligated to apply for a license to the CDC or pay royalties to the CDC.
“Gilead not only invented Truvada and Desicovy, but the concept of using Truvada to prevent HIV was well known at the time the government tried to patent it,” said a Gilead spokesperson. says.
After decades of unsuccessful vaccine development efforts, this two-drug PrEP regimen could play a key role in reducing new HIV infections in communities at high risk of the virus, including men who have sex with men. I have fulfilled.
Subsequent clinical trials have demonstrated that PrEP is 99% effective in preventing HIV infection.
