U.S. Government Files Appeal Over Gilead Truvada, Descovy HIV Drug Patents

Appeal comes as Gilead continues to face thousands of HIV drug lawsuits in California state court, alleging that users experienced bone fractures and kidney injuries due to Truvada and other TDF-based medications.

A little more than a year ago, a Delaware jury rejected a patent lawsuit filed by the U.S. government, which claimed the government partially owned Gilead’s HIV drugs Truvada and Descovy, accusing the manufacturer of illegally profiting from taxpayer dollars used to research the blockbuster treatments.

The Gilead HIV drug patent lawsuit was first filed by the U.S. Department of Justice in November 2019, alleging that the government spent hundreds of millions of dollars in clinical studies helping to develop Truvada and Descovy as pre-exposure prophylaxis (PrEP) treatments to prevent the spread of HIV. However, federal attorneys claim Gilead took that money and ran, and then profited from selling the drugs to taxpayers at inflated prices.

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

Earlier this year, the U.S. District Court for the District of Delaware issued a memorandum (PDF) granting the government the right to file an appeal. Late last week, the Justice Department filed a Notice of Appeal (PDF), again seeking 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.

The government argues that it was barred from preventing key evidence at trial, and that it should have been granted a favorable verdict based on matters of law.

According to the government’s original 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 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.

Gilead HIV Drug Lawsuit Settlement

The appeal comes about a month after Gilead announced it has agreed to pay $40 million to settle more than 2,600 HIV drug lawsuits filed by patients over its tenofovir disoproxil fumarate (TDF) medications, including Truvada, Atripla, Stribild and others.

Although the company promoted the drugs as safe and effective, plaintiffs indicate that the drug maker was aware of a safer alternative design, involving the compound tenofovir alafenamide fumarate (TAF), which reduces the risk of bone problems kidney damage and other side effects. However, Gilead allegedly delayed development of TAF-based HIV drugs until the existing TDF-based drugs neared the end of patent protections, extending the drug maker’s monopoly over the market by avoiding competition from generic competitors.

For the agreement to be finalized, it must be signed onto by 98% of eligible plaintiffs and approved by a federal judge. Gilead indicates that the settlement is not an admission of guilt.

However, the deal does not impact tens of thousands of lawsuits over the HIV drugs pending in state court, where the vast majority of claims were filed. Gilead continues to face an estimated 24,000 lawsuits that are currently centralized in the California state court system, where individual cases may soon start to go before juries.

The California state court judge presiding over the litigation is moving forward with a series of “bellwether” trials, which will allow individual representative cases to go before a jury, to help gauge how they may respond to certain evidence and testimony that will be repeated throughout the claims.

While the outcome of these early test trials will not be binding on other plaintiffs, the lawsuit payout awarded may influence the amount Gilead must pay to settle TDF-based HIV drug lawsuits, and avoid the need for each individual claim to go before a jury in California state court.