Government’s Gilead HIV Drug Lawsuit Over Patent Rights Ends in Defense Verdict

The Gilead HIV drug lawsuit filed by the Justice Department claimed the drug maker violated patents held by the CDC for the use of Truvada and Descovy as preventative treatments.

A Delaware jury has ruled against the U.S. government in a patent lawsuit over Gilead’s HIV drugs, Truvada and Descovy, which the government claimed it partially owned.

In November 2019, the U.S. Department of Justice filed a lawuit against Gilead, which accused the HIV drug maker of illegally profiting from taxpayer researcher through the sale of Truvada and Descovy as pre-exposure prophylaxis (PrEP) treatments to prevent HIV.

The government claimed it spent hundreds of millions of dollars in clinical studies to help develop the two drugs, which Gilead has profited from by selling the drugs to taxpayers at inflated prices.

Following several years of litigation and a five-day trial, a jury in Delaware federal court ruled against the government on Tuesday, handing down a defense verdict in favor of Gilead. The jury rejected the argument that drug maker had violated three government patents involving the use of Trudava as a PrEP treatment.

According to the government’s lawsuit, Gilead originally obtained FDA approval for the drugs to be used in combination with other treatments. 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.

The federal government sought more than $1 billion in damages, claiming Gilead exaggerated its role in the development of PrEP drugs and ignored the CDC’s patents. However, last year another court ruled that the government had not given Gilead enough notice before applying for those patents.

Gilead HIV Drug Lawsuits

In addition to the claim by the federal government, Gilead still faces hundreds of HIV drug lawsuits brought by individual users, who allege the drug maker failed to adequately warn about side effects associated with the certain medications, and withheld safer designs for years.

Each of the injury plaintiffs indicate they suffered renal failure, kidney injury, bone loss, fractures or other complications associated with bone deterioration following exposure to tenofovir disoproxil fumarate (TDF) based HIV drugs sold by Gilead in recent years, including Viread, Truvada, Atripla, Complera and Stribild.

According to the injury complaints, Gilead has known for years that a less toxic version of the drugs could be developed, involving the antiviral tenofovir alafenamide fumarate (TAF), yet the drug maker continued to sell the more toxic versions without adequate warnings. It was only when it was going to face competition from generic equivalents, which would diminish sales, that the drug maker introduced and marketed TAF-based drugs, promoting them as safer than the toxic TDF-drugs they had sold for years.

Plaintiffs allege that the decision to withhold development of TAF-based drugs was part of a scheme intended to allow Gilead to maintain an essential monopoly on HIV treatments until at least 2032. However, as a result of this decision to place profits before consumer safety, thousands of individuals nationwide have been left with severe injuries that may have been avoided.

While some cases have been filed in federal court, the majority of the claims have been filed in California state courts. Given common questions of fact and law, the litigation is being coordinated in California state court during discovery and a series of early “bellwether” trials will be scheduled to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout hundreds of claims.