According to an HHS news release, the filing asserts that Gilead has profited from research funded by taxpayers “and reaped billions” from the sale of two medications, Truvada (emtricitabine/tenofovir disoproxil fumarate; FTC/TDF) and Descovy (FTC/tenofovir alafenamide; FTC/TAF).

In a statement, the PrEP4All Collaboration, a group of activists seeking wider patient access to HIV PrEP, called the lawsuit “a necessary first step to ensure access to effective HIV prevention for everyone who needs it.”

Approved for use in the United States since 2012, HIV PrEP is highly effective at preventing HIV infection, but it is also expensive. According to a Gilead spokesperson, the cost of both FTC/TDF — which will come off patent in 2020 — and FTC/TAF — which was approved for PrEP just last month — is $1,758 per month.

 

The U.S. is suing Gilead for infringement of PrEP patents.

Source: Adobe Stock. 

“For nearly a decade, Gilead’s price gouging on PrEP has prevented hundreds of thousands of Americans from accessing this technology, despite it being a taxpayer-funded invention,” PrEP4All said.

In a statement, Gilead questioned the validity of patents granted to HHS since 2015 for HIV PrEP and post-exposure prophylaxis and rejected “any notion of willful infringement.”

“HHS improperly filed for patents without alerting Gilead, despite its obligation to do so, and we have openly explained the defects in the patents since becoming aware of them,” Gilead said.

The company originally received FDA approval for both medicines for the treatment of HIV infection. Following research and clinical trials undertaken by the CDC, Gilead then procured FDA approvals for both drugs to be used as PrEP, HHS said.

“HHS recognizes Gilead’s role in selling Truvada and Descovy to patients for prevention of HIV. Communities have put these drugs to use in saving lives and reducing the spread of HIV,” HHS Secretary Alex M. Azar II said in the release. “However, Gilead must respect the U.S. patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs. The complaint filed today seeks to ensure that they do.”

The Washington Post reported in April that the U.S. Department of Justice had launched a review of the government’s patent for HIV PrEP. In August, the paper said Gilead had filed a formal challenge to dispute government patents related to the medications.