News & Updates

PRESS RELEASE: PrEP4All Denounces DOJ Decision to Abandon Appeal in U.S. v. Gilead PrEP Patent Case

FOR IMMEDIATE RELEASE

For media inquiries, please contact Michael Chancley, Communications and Mobilization Manager, at michael@prep4all.org 

New York, NY (Thursday, January 16, 2025) PrEP4All strongly denounces the decision by the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) to abandon their efforts to appeal the government’s case in United States v. Gilead and secure reasonable compensation from Gilead following more than a decade of infringement on PrEP patents held by HHS. 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 and other HIV/AIDS advocacy organizations have supported the DOJ and HHS in their litigation from the very start, including with an amicus brief filed just last month. HHS’s complaint cited the work of PrEP4All and other advocacy organizations. This was a litigation brought on behalf of the community to advance the needs of the community. 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. Despite being shown repeatedly in trial documents as having been an unwilling participant in the development and FDA approval of PrEP, the company has nonetheless exploited patients and public science for over a decade while making over $10 billion from PrEP in the US alone. Gilead waited until taxpayers invested an estimated $143 million into the foundational research and only became an active participant once government and community advocates successfully proved that PrEP was effective and that there would be a demand for it. Rather than pay a reasonable royalty that could have been reinvested into efforts to increase equitable PrEP access, the company repeatedly ignored government requests to negotiate a deal and jacked prices of Truvada up by 45% over the six years following FDA approval, offering Truvada at 350 times the manufacturing cost by 2019. The consequences have been dire for communities in need of PrEP access, with communities of color and women being repeatedly left behind in access.  

“We are living in a time of unprecedented public concern about corporate interference in healthcare access; this was a rare opportunity for a behemoth like Gilead Sciences to be held accountable for selfishly undercutting PrEP access by taking advantage of taxpayer funded research and price gouging public and private payers, all without paying a cent in royalties, “ says Jeremiah Johnson, Executive Director of PrEP4All.In the five years it has taken for this case to wind through the courts, well over 150,000 unnecessary new HIV infections have happened in the US thanks in large part to Gilead’s irresponsible actions. With a final act of cowardice the Biden administration has allowed Gilead to avoid paying for its infringement of government innovation and undercut justice for our communities.”

The policy precedent set here could have harmful consequences for years to come. Chris Morten, Associate Clinical Professor of Law at Columbia Law School, said, “government-invented drugs and vaccines and government-owned patents on them are a cornerstone of the United States’s pharmaceutical system, as an amicus brief of professors of law, medicine, and public health recently explained. As HHS’s 2019 complaint stressed, Gilead broke the mold with its seemingly unprecedented refusal to consider public-private partnership and a license to HHS’s patents on PrEP. I’m disappointed that HHS has accepted a settlement that allows Gilead to walk away without paying a penny. HHS must stress that respect for the government’s own scientific contributions is essential to good-faith public-private partnership. If those partnerships break down, fewer medical breakthroughs may reach patients.”