Gilead Settles HIV Drug Lawsuit Over Patent on Truvada and Descovy

The U.S. government and Gilead have reached a settlement agreement, which ends years of litigation over who owns the patent for critical HIV drugs, including Truvada and Descovy.

Gilead issued a press statement announcing the agreement on January 15, which was reached with the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services.

The Gilead HIV drug settlement comes after a patent lawsuit was first filed by the DOJ in November 2019, alleging that the U.S. government spent hundreds of millions of dollars in clinical studies helping to develop Truvada and Descovy as pre-exposure prophylaxis (PrEP) treatments, to help prevent the spread of HIV. However, federal attorneys claimed Gilead profited from that information and funding, by selling the drugs to taxpayers at inflated prices.

In May 2023, jurors in Delaware rejected the claims, and granted Gilead a defense verdict at trial. The government quickly sought to reverse the judgment or have a new trial scheduled.

The DOJ’s appeal sought to legally force Gilead to pay $1 billion in penalties and acknowledge the U.S. Centers for Disease Control and Prevention’s (CDC) contributions and patent rights. However, as part of the Gilead settlement, the federal government has withdrawn this appeal.

The settlement between Gilead and the U.S. Justice Department does not have any impact on thousands of HIV drug lawsuits currently being pursued by former patients, which allege that Gilead failed to warn that side effects of Truvada and certain other HIV-prevention drugs increase the risk of kidney injuries and bone problems.

Justice Department Claims Against Gilead

In the past, the DOJ has argued that while Gilead received approval from the FDA for its HIV drugs to be used in combination with other medications as HIV treatments, it was the CDC that created the PrEP regimens, which were patented by the U.S. government.

The federal government sought more than $1 billion in damages, and claimed that Gilead exaggerated its role in the development of PrEP drugs and ignored the CDC’s patents.

According to Gilead’s press release, not only has the government withdrawn its appeal, but the settlement gives Gilead a license to “certain current and future government PrEP patents.” However, no financial details have yet been made available.

The statement indicates the Gilead settlement ends five years of litigation.

January 2025 Gilead HIV Drug Lawsuit Update

In June 2024, Gilead reached another settlement to resolve more than 2,600 federal HIV drug lawsuits filed by individual plaintiffs for about $40 million, resolving certain claims over the company’s tenofovir disoproxil fumarate (TDF) medications, including Truvada, Atripla, Stribild and others. However, that Gilead settlement still left thousands of cases unresolved.

Complaints have been filed by former users of the HIV drugs, who suffered bone fractures and kidney problems, alleging that Gilead delayed development of a safer formulation for its medications, involving the compound tenofovir alafenamide fumarate (TAF), used in Descovy. Plaintiffs say Gilead sat on the safer TAF-based HIV drugs until the existing patent on older TDF-based medications neared the end, in order to maximize profits and avoid generic competition.

There are currently tens of thousands of lawsuits over Truvada and other HIV drugs that are pending in California state court, which are expected to go before juries if the drug maker fails to reach another settlement with plaintiffs.