Gilead and US face off in HIV drug patent trial

Pharma company Gilead has a few HIV-prevention drug regimens on the market in the US. Its medicines Truvada and Descovy help treat HIV, and they can also help prevent it. You might’ve heard about something called PrEP, which is a regimen for preventing HIV pre-exposure, or PEP, which is for post-exposure prevention. These both involve taking Truvada and Descovy.

These regimens have helped a lot of people stay HIV-free, and they’ve also made Gilead a lot of money. Truvada generated sales of US$147 million in 2022 and US$371 million the year before. Descovy brought in US$1.87 billion in 2022 and US$1.7 billion in 2021.

Now, the US government is accusing Gilead of failing to compensate the Centers for Disease Control and Prevention (CDC) after it was the one to figure out the HIV-treatment drugs Truvada could be used to prevent the disease.

Back in the mid-2000s, Gilead worked with the CDC to look into whether or not Truvada could prevent HIV on top of treating it. Gilead then filed four patents for HIV prevention drug regimens that the CDC researchers had invented. The regimen that’s really in the conversation is the one for PrEP.

According to the original complaint from the Department of Justice: “Gilead has repeatedly refused to obtain a license from CDC to use the patented regimens. Indeed, Gilead has reaped billions from PrEP through the sale of Truvada and Descovy but has not paid any royalties to CDC.”

Basically, the US is coming after Gilead for patenting drug regimens and then making money off of these regimens that were worked on by the CDC without actually giving the CDC any of that money. Now the US government is seeking US$1 billion in damages.

Meanwhile, Gilead is saying the CDC's claims that it developed the PrEP regimen aren’t true. And the company is also saying that it was never obligated to apply for a license with the CDC or pay the agency any royalties.

“Not only did Gilead invent Truvada and Descovy, but the concept of using Truvada to prevent HIV was well-known by the time the government tried to obtain its patents,” a Gilead spokesperson said.