The Gilead Sciences logo displayed on a laptop screen and medical pills are seen in this illustration photo taken in Krakow, Poland, October 18, 2021. (Photo by Jakub Porzycki/NurPhoto via Getty Images)
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Teachings of Gilead and the U.S. government faced off in court on Tuesday on the primary day of a trial that can examine allegations that the drugmaker infringed on patents on a key HIV-preventing drug regimen.
The US is trying to implement 4 patents issued to the Centers for Disease Control and Prevention for a two-drug regimen often called pre-exposure prophylaxis, or PrEP for brief. The federal government accuses Gilead of reaping billions of dollars from the sale of PrEP without paying royalties to the CDC.
The US filed a lawsuit against Gilead in 2019. Gilead rejected US allegations that the corporate’s sales of its oral PrEP drugs, Truvada and Descovy, infringe all CDC patents.
The trial in Delaware federal district court is anticipated to last six days.
Researchers on the CDC discovered in the mid-2000s that two drugs, emtricitabine and tenofovir, taken together were very effective in stopping HIV infection, according to a US government lawsuit.
Gilead’s Truvada and Descovy contain emtricitabine and tenofovir. Truvada and Descovy combined worldwide sales of roughly $2 billion in 2022.
“Gilead has repeatedly refused to obtain a license from the CDC to use the patented schemes,” DoJ lawyers wrote in the unique grievance. “Indeed, Gilead raised billions from PrEP through the sale of Truvada and Descova, but didn’t pay CDC any royalties.”
“Subsequently, Gilead knowingly and intentionally infringed CDC patents and continues to achieve this,” the Department of Justice said.
Gilead rejects the CDC’s claims that the agency’s scientists developed the PrEP regimen. The corporate said it was not obligated to apply for a license with the CDC or pay any licensing fees to the agency.
“Not only did Gilead invent Truvada and Descova, however the concept of using Truvada to prevent HIV was well-known when the federal government was trying to get its patents,” a Gilead spokesperson said.
This two-drug PrEP regimen has been instrumental in limiting latest HIV infections in communities which might be more vulnerable to the virus, reminiscent of men who’ve sex with men, after a long time of failed attempts to develop a vaccine.
Subsequent clinical trials have shown that PrEP is 99% effective in stopping HIV infection.