The United States government filed a patent infringement lawsuit against Gilead Sciences in federal district court, accusing the drug maker of “willfully and deliberatively” infringing on HHS patents for pre-exposure prophylaxis, or PrEP, for HIV prevention.
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.
“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.
“The United States Patent and Trademark Office granted four patents to HHS that protect CDC’s work and the taxpayers’ investment,” the HHS said in announcing the lawsuit. “These patents entitle HHS to license CDC’s PrEP regimens and receive a reasonable royalty for their use. Two other companies that manufacture generic equivalents of Truvada for PrEP in foreign countries have agreed to licenses with HHS.”
According to The Washington Post, Gilead earned $3 billion last year through the sale of FTC/TDF.
“The fact remains that Gilead invented Truvada and funded the clinical trials that led to its 2004 FDA approval for use in combination with other antiretroviral agents to treat HIV,” Gilead said. “The company has spent an estimated $1.1 billion on [research and development] related to Truvada — to develop the two individual drugs that make up Truvada, invent the combination product that is Truvada, invent its use for HIV treatment and support the clinical trials that led to the approval of Truvada for PrEP. Similarly, Gilead invented and shouldered the cost of developing Descovy. Any claim to the contrary is false.”