Government Lawsuit Alleges HIV Drug Maker Gilead Profited Illegally From Taxpayer Research

Gilead faces a lawsuit brought by the United States government, which accuses the HIV drug maker of illegally profiting from taxpayer research through the sale of the widely used treatments Truvada and Descovy.

The U.S. Department of Justice issued a press release announcing the lawsuit on Thursday, which was filed in Delaware federal court against Gilead Sciences. The patent lawsuit indicates the government spent hundreds of millions of dollars on clinical studies, and now Gilead is profiting by selling the drugs to the taxpayers who helped created it at highly inflated prices.

Gilead is allegedly infringing on four patents owned by the U.S. Department of Health and Human Services (HHS) through its sale of Truvada and Descovy as pre-exposure prophylaxix (PrEP), according to the lawsuit. The two HIV drugs are believed to be 99% effective at preventing the transmission of HIV when taken daily by those without the disease.

According to the lawsuit, Gilead originally obtained FDA approval for the drugs to be used in combination with other drugs. However, in the early 2000’s, researchers at the U.S. Centers for Disease Control and Prevention (CDC) created new regimens to prevent the spread of HIV. Those regimens were patented by the U.S. government.

Gilead then began to sell the drugs, emtricitabine and tenofovir, which had previously only been for treatment of already infected persons, as Trudava for PrEP, and has generated billions of dollars in sales among individuals who are at high risk of developing HIV.

“It was only after CDC’s innovative PrEP work and subsequent human trials that Gilead sought FDA approvals for Truvada, and more recently Descovy, to be used as part of PrEP drug regimens to prevent HIV,” the Justice Department press release states. “Gilead now markets and sells Truvada and Descovy for PrEP regimens that CDC developed and patented.”

Justice department officials say Gilead never sought to obtain a licenses for use of the patented treatments, and in fact has explicitly refused to do so and challenged the validity of the patents in court.

“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 press 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 HIV drug lawsuit comes as lawmakers are attempting to get Gilead to bring down the price tag for Truvada, which can cost up to $2,000 a month for those without insurance. Bringing the price down would be key in helping the drugs get to critical populations at high risk of HIV, and thus would help combat the spread of the disease, experts say.

When Truvada first went on the market in 2004, it cost $800 per month. At a recent congressional hearing, the late Congressman Elijah Cummings noted that, over the same time period, Gilead had generated $36 billion on Truvada alone.

Just before the hearing, held in May, Gilead said it was donating 2.4 million Truvada pills, which would serve about 200,000 at-risk individuals without health insurance. However, there are an estimated 1.1 million such individuals in the U.S., and U.S. customers, or their insurance companies, pay 250 times as much for Truvada as someone in Australia pays for the exact same medication.

In addition to the Justice Department lawsuit, Gilead faces a growing number of individual HIV drug lawsuits over bone and kidney problems linked to Truvada and other medications that contain tenofovir disoproxil fumarate (TDF). Those plaintiffs claim that Gilead knew about a safer alternative in 2004, known as tenofovir alafenamide (TAF), which is used in Descovy and other drugs introduced in recent years, yet held off on development of the newer drugs until Truvada and other TDF-based drugs started facing generic competition.