U.S. Government Sues Gilead Over PrEP Patent Infringement

Officials have accused the company, which sells HIV-prevention drugs, of earning billions from taxpayer-funded research with no return to taxpayers.

The Trump administration has filed a lawsuit against Gilead Sciences, the pharmaceutical company the manufactures Pre-exposure prophylaxis (PrEP), the potentially life-saving HIV prevention drug also known by its brand name Truvada.

The suit, filed this Wednesday, has accused Gilead, which has earned billions in profit from taxpayer-funded medical research with no return to taxpayers, of patent infringement, The New York Times reports. Government officials from the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Service claim Gilead has infringed upon patents owned by HHS—and has refused repeated attempts from the government to license its patents and obtain royalty payments.

The drug manufacturer has publicly rebuffed the CDC’s 2015 patent on PrEP, all the while continuing to pull in staggering profits from sales of Truvada and Descovy, a newer HIV medication.

“Gilead must respect the U.S. patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs,” HHS secretary Alex M. Azar II said in a press statement. “The complaint filed today seeks to ensure that they do.”

As NewNowNext previously reported, HIV/AIDS activists have long criticized Gilead’s high retail markups on Truvada, which can cost uninsured patients thousands of dollars for a monthlong supply. (No generic option is currently available in the U.S.)

Though PrEP is available at little to no cost to Americans on Medicaid or private health insurance plans, the list price per year is about $20,000, The Times reported last July.

HIV/AIDS advocates and LGBTQ activists from groups like PrEP4All have urged Gilead to break its brand-name patent on PrEP, with some success. As NewNowNext reported in May, a generic version of Truvada will be available as early as 2020, a year earlier than expected.

Though this lawsuit does suggest a desire from the Trump administration to combat the spread of HIV/AIDS in the U.S., advocates have still called the president’s commitment to the cause into question. And for good reason: In 2017, Trump fired the remaining members of Obama’s Presidential Advisory Council on HIV/AIDS with no warning or explanation. In 2018, he took the side of conservative Christians and put a halt to medical research using stem cells that might have been close to finding a cure for HIV.

As recently as this July, the United Nations claimed that the global fight to end the spread of HIV/AIDS has largely stalled.

Brooklyn-based writer and editor. Probably drinking iced coffee or getting tattooed.
@_sammanzella