Gilead Sciences logo displayed on a laptop screen and medical pills are seen on 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 U.S. government faced off in court Tuesday in the primary day of a trial that may probe allegations that the drugmaker violated patents for an important HIV prevention drug regimen.
The U.S. is attempting to implement 4 patents issued to the Centers for Disease Control and Prevention on a two-drug regimen referred to as pre-exposure prophylaxis, or PrEP for brief. The federal government accuses Gilead of reaping billions of dollars in PrEP sales without paying royalties to the CDC.
The U.S. filed the lawsuit against Gilead in 2019. Gilead has rejected U.S. allegations that the corporate’s sales of its PrEP oral medications, Truvada and Descovy, infringe on any CDC patents.
The trial in Delaware federal district court is predicted to last six days.
Scientists on the CDC discovered within the mid-2000s that two drugs, emtricitabine and tenofovir, taken together were highly effective in stopping HIV infection, in response to U.S. government’s lawsuit.
Gilead’s Truvada and Descovy each contain emtricitabine and tenofovir. The corporate’s combined sales worldwide for Truvada and Descovy were about $2 billion in 2022.
“Gilead has repeatedly refused to acquire a license from CDC to make use of the patented regimens,” Justice Department lawyers wrote in the unique criticism. “Indeed, Gilead has reaped billions from PrEP through the sale of Truvada and Descovy, but has not paid any royalties to CDC.”
“Accordingly, Gilead has willfully and deliberately induced infringement of CDC’s patents and continues to achieve this,” the DOJ said.
Gilead rejects CDC claims that agency scientists developed the the PrEP regimen. The corporate said it is not obligated to use for a license with the CDC or pay the agency any royalties.
“Not only did Gilead invent Truvada and Descovy, however the concept of using Truvada to forestall HIV was well-known by the point the federal government tried to acquire its patents,” a Gilead spokesperson said.
This two-drug PrEP regimen has played a key part in reducing latest HIV infections in communities that face the next risk from the virus, similar to men who’ve sex with men, after many years of failed efforts to develop a vaccine.
Subsequent clinical trials have demonstrated that PrEP is 99% effective at stopping HIV infection.
