The Department of Health and Human Services says in a new lawsuit that they own the patents to Truvada, a.k.a. PrEP, and they’re hauling Bay Area pharma giant Gilead Sciences to court in a case that could remake the HIV treatment landscape.

We think of the antiviral HIV treatment Pre-Exposure Prophylaxis (PrEP) as a revolutionary regimen that not only treats AIDS, but also has been shown to prevent the spread of the infection when taken regularly by HIV-negative people. And it does! Porn stars use it! State Senator Scott Wiener uses it! But PrEP, a treatment that comes in the form of a drug called Truvada manufactured by Foster City-based pharmaceutical company Gilead Sciences, is incredibly pricey at $2,000 a month. HIV activists point out that the drug only costs $6 a month to produce. Sure, that’s just typical American pharmaceutical industry exploitation, but the federal government sees an even more insidious wrinkle in the outlandish cost of PrEP drugs. The Centers for Disease Control argues that they actually own the patent to Truvada, and the New York Times reports that the Trump administration is suing Gilead Sciences for patent infringement.

“PrEP is not Gilead’s invention, it’s the American taxpayer’s invention and because [the CDC] invented it and owns four patents protecting that invention, Gilead needs to in some way pay back the American taxpayers,” PrEP4All co-founder James Krellenstein told Out magazine just after the lawsuit was filed Wednesday. “That can be in monetary royalties — the Financial Times estimates that Gilead owes at least a billion dollars back to the American taxpayer — but it can also be other things. Like commitments to increase access and make sure PrEP is universally available.”

Gilead Sciences has not commented on the lawsuit, but in May announced they’d donate enough Truvada to treat “200,000 patients annually for up to 11 years,” according to the Times. Still, that’s just a small fraction of the estimated more than a million Americans who need the drug, but are priced out from using it.

This is a rare example of the Trump administration taking the lead of far-left Democrats in Congress. Back in May, Alexandria Ocasio-Cortez (D-NY) ripped Gilead Sciences CEO Daniel O’Day a new one over the pricing of drug that was invented through taxpayer-funded research.

“We the people developed this drug, we paid for this drug, we led and developed all of the grounding patents to create PrEP, and that patent has been privatized,” Ocasio-Cortez said at the hearing. “People are dying because of it.”

Holy shit. Dr. Robert Grant, the father of PrEP development (principal investigator on all the original trials), will be...

Posted by Peter Staley on Wednesday, May 15, 2019

The core of this lawsuit comes down to who really invented PrEP, which doesn’t just treat HIV, but can prophylactically prevent the spread of the infection. "Gilead Sciences did not provide leadership, innovation, or funding for these projects," said Dr. Robert Grant, described by Public Citizen as the ‘father of PrEP.’ "Gilead’s role was limited to donating study medication and placebos."

Related: PrEP Could Become Over-the-Counter Drug In California [SFist]

Image: Tony Webster via Flickr