A confidential research and development agreement between the Biden administration and Gilead Sciences, obtained by HIV advocacy group PrEP4All through a 15-month Freedom of Information Act battle and reported by STAT News on July 13, has reignited criticism of the lame-duck settlement that ended a years-long patent dispute over the HIV prevention drug Truvada.
Advocates say the deal amounted to a giveaway of publicly funded intellectual property worth billions of dollars.
The patent dispute
The conflict dates to 2019, when the Trump administration sued Gilead on behalf of the Centers for Disease Control and Prevention (CDC), alleging that the company had infringed four government-held patents covering the use of Truvada as pre-exposure prophylaxis (PrEP) for HIV. CDC researchers had been the first to prove Truvada’s preventive efficacy in a landmark study largely funded by federal grants. The government filed for patent protection in 2006, and four patents were approved in 2015.
Gilead argued the patents were invalid due to obviousness. In May 2023, a Delaware federal jury agreed, ruling that Gilead did not infringe and that the government’s patents were invalid. The government appealed.
The settlement
On January 15, 2025, four days before President Trump’s second inauguration, the Biden administration’s Department of Justice and Department of Health and Human Services settled the case. The terms: Gilead received a license to “certain current and future government PrEP patents,” the government dropped its appeal of the 2023 verdict, and no monetary payment was made by Gilead.
“The government gave up its patent rights without getting a cent in royalties,” said Jeremiah Johnson, executive director of PrEP4All, in a statement. “This is a shocking injustice.”
The M-CRADA (Materials Cooperative Research and Development Agreement), the confidential R&D pact between the government and Gilead, had been kept secret since the settlement was signed. PrEP4All finally obtained it in July 2026 after filing a FOIA lawsuit against the Trump administration’s agencies.
The numbers at stake
The financial context is striking. Gilead generated over $10 billion in U.S. PrEP revenue between 2015 and 2021, built on foundational research supported by $143 million in taxpayer funding. The government’s original damages demand was estimated at $691 million for Truvada and $311 million for Descovy.
At the time of the settlement, the average wholesale price of Truvada exceeded $20,000 per patient per year, roughly 350 times the manufacturing cost. Generic versions cost as little as $70 per month in other countries.
PrEP4All and allied groups argue that the government could have used its march-in rights under the Bayh-Dole Act to break Gilead’s patent exclusivity on public health grounds, but never did. An estimated 2.25 million Americans could benefit from PrEP, but fewer than 600,000 currently use it.
The broader implications
The settlement has become a flashpoint in the ongoing debate over public investment in pharmaceutical research versus corporate pricing. Critics say the Biden administration, which had positioned itself as a champion of healthcare access, squandered a historic opportunity to address drug pricing.
“The lame-duck Biden administration’s decision to drop the appeal and sign a secret R&D agreement with Gilead will tarnish the President’s image as a champion of healthcare access,” Johnson said.
The case also has implications for Gilead’s next-generation PrEP drug, lenacapavir, a twice-yearly injectable that activists worry may be locked into similar pricing and access terms through the M-CRADA.
The M-CRADA was signed by the Biden administration. The current Trump administration has not commented on the agreement or indicated whether it intends to revisit the settlement terms.
Sources
“Pharmalot: AIDS activists slam Biden R&D deal with Gilead over HIV prevention patents.” STAT News (July 13, 2026). https://www.statnews.com/pharmalot/2026/07/13/aids-activists-slam-biden-deal-with-gilead-over-hiv-prevention-patents/
PrEP4All press releases and FOIA filings (2025-2026).