U.S. Sues Gilead Sciences Over HIV Prevention Drug

In a rare move by the Trump administration, the U.S. filed a patent infringement lawsuit against Gilead Sciences, manufacturer of Truvada, an HIV prevention drug. The therapy was invented and patented by researchers at the Centers for Disease Control.

Alex Azar, secretary of the Department of Health and Human Services, stated that “Gilead must respect the U.S. patent system” and that the lawsuit filed on Wednesday will “ensure that they do.”

In a press release, HHS said Gilead “willfully and deliberately induced infringement of the HHS patents.”

As a result, the department said, Gilead has generated hundreds of millions in profits from patents that were funded by taxpayers. In 2018, Gilead generated $3 billion in sales of Truvada.

The pill, known as PrEP, is for pre-exposure prophylaxis, and costs approximately $1,750 per month. The cost of the drug has steadily increased since its approval in 2004. At the time of approval, the wholesale cost for a month’s supply of the drug was $650.

When the drug was approved for HIV prevention in 2012, the cost shot up to $1,159.

Gilead argued that the increased price supported more research.

HHS says that “Gilead has repeatedly refused to obtain licenses for the use of HHS patents.” Gilead has been in talks with HHS for the last three years, but has refused to agree to a license.

HIV activists say the move is a step towards making Truvada more widely available to those in need.

Truvada for PrEP has been the focal point of public health strategies to eliminate HIV and AIDS by 2030. But the high cost of the drug has been criticized by public health officials and activists.

PrEP4All Collaboration says Gilead’s “price gouging” has kept Truvada out of reach for hundreds of thousands of Americans. The organization is calling for HHS to leverage its patents to ensure everyone who needs PrEP can receive it.