PrEP4All, the national nonprofit organization focused on expanding access to HIV prevention and creating a national, federally funded PrEP program, today released newly obtained government records revealing that the U.S. government abandoned a historic opportunity to protect taxpayers’ investment in PrEP and expand access to HIV prevention through a National PrEP Program.

The records — including the complete settlement agreement and previously undisclosed supporting documents in United States v. Gilead — were obtained only after PrEP4All pursued months of Freedom of Information Act (FOIA) litigation against the federal government. The case involved government-held patents for PrEP (pre-exposure prophylaxis), one of the most effective biomedical tools for preventing HIV, developed through at least $143 million in taxpayer-funded research.

Together, the documents confirm what advocates had feared for years: despite government-held patents stemming from taxpayer-funded research, the federal government ultimately surrendered its remaining leverage over Gilead without securing meaningful public benefit in return. The groundbreaking 2019 case was originally brought by the first Trump administration at the behest of PrEP4All.

“It’s hard to picture a worse outcome from this case. At a time when state prevention programs are shutting down due to attacks on federal HIV funding and out-of-control healthcare prices, this was an opportunity to secure over $1 billion in funds to establish a National PrEP Program and put us back on track to end HIV as an epidemic by 2030.” says Jeremiah Johnson, Executive Director of PrEP4All. “Instead, the Biden administration decided in the eleventh hour to abandon its appeal of the case, give up its remaining leverage over the company, and essentially reward Gilead for infringing on government-held patents.”

While advocates had hoped that a final materials cooperative research and development agreement, or M-CRADA, that was referenced in the original U.S. v. Gilead settlement agreement would shed light on some kind of favorable outcome for the government—and by extension the communities most in need of PrEP access—the agreement contained only boilerplate language on collaborations, vaguely aspiring to future research on PrEP, with no meaningful concessions by the company. The M-CRADA and settlement agreement together reveal that the government yielded its patent rights for little in return, giving Gilead carte blanche to continue to freely reap the rewards of taxpayer-funded research. 

Under both the Biden and second Trump administrations, the Department of Health & Human Services (HHS) and Department of Justice (DOJ)—which litigated United States v. Gilead on behalf of the government and the American public—have declined to offer any public statement explaining the decision to settle the case when and how they did. Neither HHS nor DOJ made the U.S. v. Gilead settlement agreement or M-CRADA publicly available. PrEP4All first brought the settlement agreement to light earlier this year, after filing and then litigating a Freedom of Information Act request. PrEP4All likewise obtained the M-CRADA via a Freedom of Information Act request and was again forced to litigate to compel release of the document. 

“Gilead did not lead or pay for the foundational research for Truvada as PrEP. Gilead did not want to cooperate with government efforts to obtain FDA approval for Truvada as PrEP. Gilead remained a reluctant participant in PrEP’s development and rollout until it discovered that there was big money to be made,” explained Christopher Morten, Director of the Science, Health & Information Clinic at NYU Law and long-time pro bono attorney for PrEP4All. “After Gilead realized PrEP’s multi-billion dollar potential and jacked up its prices, the company rebuffed repeated requests by the Centers for Disease Control & Prevention (CDC) to pay reasonable royalties, in recognition of the government’s research and development of PrEP. When, after much urging by PrEP4All and other advocates, the first Trump administration took action to bring Gilead to court, the company spent many millions on lawyers to swamp the arguments of HHS and DOJ attorneys. In the end, Gilead keeps well over $10 billion in profits on PrEP—and that’s just counting sales to U.S. patients. In effect, Gilead gets away with exploitation of patients, taxpayers, and government scientists. The lopsided settlement creates a bad policy precedent and unnecessary injustice.”

Despite the disappointing outcome, advocates remain undaunted in their pursuit of fair and equitable access to PrEP. “We have been pursuing every pathway and knocking on every door to ensure that justice will prevail for communities in need of PrEP.” explains Johnson. “Policymakers still have the chance to realize the promise that U.S. v. Gilead represented, by supporting innovative PrEP legislation introduced by Rep. Bonnie Watson Coleman that would establish a National PrEP Program. They can also call for robust federal funding for HIV prevention that would expand National PrEP Program pilots established by the CDC following advocacy led by PrEP4All. And they can work with advocates to demand that Gilead set a public health price for lenacapavir (Yeztugo), a six-month injectable form of PrEP supported once again by taxpayer research yet out of reach of publicly funded programs due to its $28,000 price tag.”

“One way or another, we will get PrEP to everyone who needs it.”

See more coverage at STAT News – AIDS activists slam Biden R&D deal with Gilead over HIV prevention drug patents