On Dec. 19, 2024, we joined other professors of law, medicine, and public health to file an amicus brief in support of the U.S. government in the government’s landmark patent lawsuit against leading HIV drugmaker Gilead Sciences Inc.
On Jan. 15, 2025, the U.S. government and Gilead announced a settlement of the suit that — at least based on what’s been made public — allows Gilead to expropriate publicly funded, publicly owned patents essentially without recourse. Unless the Department of Health and Human Services commits to asserting its patent rights vigorously in the future on behalf of the public, this settlement could disturb the model of public-private partnership that sustains many of the United States’ most important medical breakthroughs. Gilead’s short-term win could come at massive cost to the future of pharmaceutical innovation and to the health of the American public.
The U.S. government filed the lawsuit in 2019, alleging that Gilead infringes several patents owned by HHS on HIV pre-exposure prophylaxis (PrEP). Scientists at the Centers for Disease Control and Prevention, an agency of HHS, first filed the patents in the 2000s after conducting breakthrough early-stage research on HIV prevention, establishing in animal studies that a once-a-day pill can block transmission of HIV.
HHS and the Department of Justice alleged that Gilead for years ignored the CDC’s clear contributions to the invention of PrEP, exaggerated the company’s own role in developing PrEP, refused to discuss taking a license to HHS’s patents, and failed to be a good-faith partner in maximizing Americans’ access to PrEP. HHS observed that “Gilead has profited from research funded by hundreds of millions of taxpayer dollars and reaped billions from PrEP through the sale of Truvada® and Descovy®.” At trial, HHS sought damages from Gilead of more than $1 billion — money that HIV/AIDS advocates say could and should be used to fund a national HIV prevention program that would greatly increase access to PrEP. HHS lost the trial and appealed to the Federal Circuit (the appellate court that hears patent appeals), where our amicus brief was filed.
The professors’ amicus brief of which we were part explained the context of the United States v. Gilead litigation and its policy consequences. Public-private partnerships drive many of the biggest pharmaceutical breakthroughs, including cancer treatments, Covid vaccines, and many more. As our brief explained, these partnerships help get discoveries to patients quickly and safely. Sustaining these partnerships requires mutual respect for contributions both public and private, including a willingness by private participants to acknowledge and pay for the public technologies they use. Our brief summarized Gilead’s seemingly unprecedented refusal to consider such public-private partnership, which would have included a license to HHS’s patents on PrEP.
The settlement between Gilead and HHS has not yet been made public. However, STAT’s Ed Silverman reported that Gilead received a license to HHS’s patents in exchange for a release from any obligation to pay Gilead damages for alleged breach of contracts between the company and the CDC. No money will change hands. All litigation has been dismissed with prejudice. It seems HHS traded away a claim for patent infringement potentially worth over $1 billion to avoid substantially smaller-scale liability.
Why? The settlement’s timing is odd. The government faced a long and uphill battle through the appeal and beyond, but its opening appeal brief had been filed, and the appeal seemed winnable. Who is responsible for the settlement? It’s currently unclear who in leadership at HHS and DOJ approved this deal.
The HIV/AIDS advocacy group PrEP4All, which helped instigate the litigation back in 2019, pulled no punches in a public statement denouncing the settlement: “This is a shocking injustice at a time when Americans are increasingly anxious about corporate greed limiting access to healthcare. And it is a late and completely unnecessary decision by a lame duck Biden administration that will unfortunately tarnish the President’s image as a champion of healthcare access.” PrEP4All added, “It’s outrageous that PrEP4All and other organizations weren’t consulted in the decision to abandon the litigation. With the dismissal of this litigation, Gilead has managed to avoid any responsibility and accountability for deliberately infringing government owned PrEP patents.”
We call on HHS and DOJ to release the settlement agreement, in full. The public needs to understand how and why this landmark litigation was resolved. The government owes patients, health care providers, and the public health community a full and public accounting of why it abandoned efforts to demand more from Gilead.
The settlement of United States v. Gilead will likely have far-reaching ripple effects. As our amicus brief described, HIV PrEP is just one of many examples of medical breakthroughs that originated in the National Institutes of Health, CDC, and other laboratories of HHS. A disproportionate share of the most valuable drugs, vaccines, and other medical tools start in HHS’s laboratories and make their way to patients through public-private partnership overseen by HHS.
Gilead’s lawyers suggested there was something exceptional, even villainous, about HHS’s decision to patent HIV PrEP and ask Gilead for a license as part of broader public-private partnership. In fact the government’s patenting and licensing of its breakthrough invention of HIV PrEP was routine. What was exceptional was Gilead’s refusal to consider a license even as it earned billions.
As our amicus brief explained, Gilead’s precedent now risks undermining the norms of public-private partnership that undergird much of the U.S. pharmaceutical system. More companies may borrow Gilead’s playbook and try to profit from NIH and CDC research without paying patent licenses and without partnering with the agencies on clinical trials, regulatory approval, patient education, and other initiatives that help get products to patients safely, speedily, and widely. Gilead’s blatant disregard for the patents and the knowledge contributed by the government threatens the stability not just of this relationship, but of future partnerships. Without robust public-private partnerships, the United States could lose its leadership in biomedical innovation.
Since the settlement, Gilead has promised to “work together [with HHS] toward our common goal to end the HIV epidemic for everyone, everywhere.” HHS must hold Gilead to its promise.
Going forward, HHS must remain assertive about its own rights and the public’s interests as it continues to seek and shape other public-private partnerships. HHS’s recent agreement with Pfizer and BioNTech to recover unpaid royalties on NIH-owned coronavirus vaccine patents is a promising sign that HHS is continuing to enforce its patents. We also laud NIH’s recently announced Intramural Research Program Access Planning Policy, designed to expand equitable patient access to products that emerge from NIH’s intramural research, which promises to use licenses to NIH-owned patents in ways that increase patient access.
Early actions of the second Trump administration now threaten greater disruptions to the country’s health and research ecosystems. Indeed, they threaten horrific chaos. If the Trump administration is interested in truly disrupting the status quo to Americans’ benefit, it should focus on the lessons of United States v. Gilead — on disrupting the privatization of public knowledge. The American people deserve a better deal with the companies that benefit from publicly funded research. We hope that HHS’s leadership will recognize the immense benefits not just of government research but of vigorous oversight of the companies that exploit that research.
Disclosure: Four of the authors (C.J.M., B.A., A.K., and K.Z.) are lawyers and law students who have represented PrEP4All, pro bono. They advocated the United States v. Gilead litigation and a settlement that would have secured royalty payments to the CDC.
Christopher J. Morten, J.D., Ph.D., is associate clinical professor of law, Columbia Law School. Ben Anderson is a student attorney at the NYU School of Law Science, Health, & Information Clinic. Charles Duan, J.D., is assistant professor of law, American University Washington College of Law. Gregg Gonsalves, Ph.D., is associate professor of epidemiology, Yale School of Public Health. Cynthia M. Ho, J.D., is Clifford E. Vickrey research professor, Loyola University Chicago School of Law. Amy Kapczynski, J.D., M.A., M.Phil., is professor of law, Yale Law School. Jordan Paradise, J.D., is Georgia Reithal professor of law, Loyola University Chicago School of Law. Reshma Ramachandran, M.D., M.P.P., M.H.S., is assistant professor of medicine, Yale School of Medicine. Joseph S. Ross, M.D., M.H.S., is professor of medicine and public health, Yale School of Medicine. Michael S. Sinha, M.D., J.D., M.P.H., F.C.L.M., is assistant professor of law, Saint Louis University School of Law. Anthony D. So, M.D., M.P.A., is distinguished professor of the practice, Johns Hopkins Bloomberg School of Public Health. Liza Vertinsky, J.D., M.A., Ph.D., is professor of law, University of Maryland Francis King Carey School of Law. Kiran Zelbo is a student attorney at the NYU School of Law Science, Health, & Information Clinic.