The national HIV advocacy group PrEP4All filed a federal lawsuit against four Trump administration agencies to force the release of an undisclosed agreement between them and pharmaceutical giant Gilead Sciences regarding HIV prevention research and policy.
It is the latest lawsuit in nearly seven years of legal actions aimed at uncovering details of the collaborations between the federal government and Gilead and the ownership of patents involving pre-exposure prophylaxis, or PrEP, which refers to the pills or injections taken by HIV-negative people to prevent acquiring the virus.
PrEP4All filed the current lawsuit against the Department of Health and Human Services (HHS), the Department of Justice (DOJ), the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) on April 28. Gilead Sciences is the main drugmaker of HIV antiretrovirals; the pharma giant is responsible for many of the blockbuster meds used for treatment and prevention, including three of the four PrEP drugs: Truvada, Descovy and Yeztugo.
PrEP4All’s lawsuit wants to make public the materials cooperative research and development agreement (M-CRADA) between the federal agencies and Gilead regarding their HIV prevention work. PrEP4All had already sought the M-CRADA through a formal Freedom of Information Act (FOIA) request, but when that failed to produce the documents, the advocates took legal action.
At the heart of the matter are questions about PrEP patents. Specifically, the U.S. government filed a lawsuit in 2019, United States v. Gilead, alleging that Gilead infringed on government-owned patents and then profited on the prevention research that was funded by taxpayers. In May 2023, a federal court jury in Delaware ruled in Gilead’s favor. The following month, the federal government sought a new trial, asking a judge to overturn the verdict because the jury had been misled.
The case was unexpectedly settled in January 2025. Details of the settlement were not disclosed, but in a statement, Gilead said it “will receive a license to certain current and future government PrEP patents that will protect Gilead’s freedom to operate for years to come.”
Details of the settlement revealed the existence of the M-CRADA, but the document’s individual elements were not disclosed. HIV advocates had not been aware of this agreement and have since been trying to bring its contents to public light.
In a statement, PrEP4All said it will publicly share the M-CRADA and analyze the information, as it may contain vital information about future HIV prevention research and public health strategies.
“If government held patents and taxpayer-funded science leads to lifesaving HIV prevention, then the public deserves full transparency on what happens next,” said PrEP4All executive director Jeremiah Johnson in a press release. “Right now, that transparency is missing—and that’s why we’re taking action. People deserve to understand the agreements shaping access to care that can impact their lives.”
“PrEP4All is yet again taking the U.S. government to court to vindicate its right to information,” added Christopher Morten, director of the Science, Health & Information Clinic at New York University School of Law and pro bono attorney for PrEP4All. “The public has a right to know what public agencies are up to, and that right is of the utmost importance when those agencies’ decisions impact public health. This FOIA lawsuit is unfortunately a necessary step because the agencies are months late in complying with their legal obligation to share information with the public.”
Of note, this PrEP4All lawsuit is not to be confused with a separate legal case involving Gilead’s alleged decision to delay development of potentially safer HIV medication. Last week, the California Supreme Court heard arguments regarding that case.
To date, the Food and Drug Administration (FDA) has approved four forms of PrEP: Truvada and Descovy are daily pills; Apretude is a shot given every two months; and Yeztugo is a twice-yearly injectable that is highly effective in women, gay men and gender-diverse populations. Due to insufficient evidence, Descovy is not yet indicated as PrEP for cisgender women and trans men. Generic (and much cheaper) versions of Truvada are available. To learn more about PrEP, see the POZ Basics on HIV Prevention: Pre-Exposure Prophylaxis (PrEP).
Under the rules of the Affordable Care Act (ACA, or Obamacare), health insurers must cover preventive health services that receive an A or B grade from the U.S. Preventive Services Task Force (USPSTF). In August 2023, USPSTF gave an A grade to all three PrEP forms of HIV prevention that had been approved at that time: Truvada, Descovy and Apretude. (Yeztugo, also known as lenacapavir, was approved in 2025; advocates urge health care insurers to cover it as well.)
In recent years, conservatives have filed lawsuits challenging the ACA’s mandate to cover preventive health services. These include not just PrEP but also cholesterol-lowering statins, vaccines and many screenings for cancer, diabetes and hepatitis.
In June 2025, the Supreme Court upheld the ACA mandate to cover these preventive services but stressed that the task force falls under the leadership of the nation’s health secretary. Currently, that person is Robert F. Kennedy Jr., who is already dismantling federal health programs and services. In 2025, he removed all members of the Advisory Committee on Immunization Practices (ACIP), a panel of experts that sets U.S. vaccine policy. As a result, the future of the USPSTF and PrEP insurance coverage remain unclear.
