The Trump administration took the rare step Wednesday of filing a patent infringement lawsuit against pharmaceutical manufacturer Gilead Sciences over sales of Truvada for HIV prevention, a crucial therapy invented and patented by Centers for Disease Control researchers.
“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. The complaint filed today seeks to ensure that they do,” said Alex Azar, the secretary of the Department of Health and Human Services, in a statement.
In a news release Wednesday night, HHS said Gilead had “willfully and deliberatively induced infringement of the HHS patents.’’
The department said as a result, “Gilead has profited from research funded by hundreds of millions of taxpayer dollars and reeped billions from PrEP’’ through the sale of Truvada and a newer Gilead drug, Descovy. Despite efforts by the government to reach an agreement, the department said, “Gilead has repeatedly refused to obtain licenses for the use of the HHS patents.’’
The action follows an article in March in The Washington Post that described the standoff between Gilead and the CDC and the National Institutes of Health over the patent for Truvada for PrEP. The Post reported on frustration among activists and researchers that the government had not taken legal action in the face of Gilead’s defiance, despite having won its patents in 2015.
In April, The Post reported that the Department of Justice had opened a review of the patent.
Gilead has disputed the government’s patents, filing a formal challenge to the patents in August. Gilead did not respond to a request for comment Wednesday night.
HIV activists said the government’s move was a “first step’’ toward making Truvada for PrEP more widely available.
Truvada for PrEP is the linchpin of public health strategies to eradicate HIV and AIDS by 2030, a goal adopted by President Trump. But the cost of the drug — $20,000 a year — has been criticized by activists and public health officials. Gilead earned $3 billion on sales of Truvada in 2018.
“For nearly a decade, Gilead’s price gouging on PrEP has prevented hundreds of thousands of Americans from accessing this technology, despite it being a taxpayer funded invention,’’ said a statement by the PrEP4All Coalition. “If HHS is truly invested in ending the HIV epidemic, it will use these patents as leverage to ensure that everyone who needs PrEP can get it.”
The CDC and other federal health officials have said little about the dispute previously. HHS said Wednesday that CDC scientists discovered the prevention use Truvada — which Gilead had developed to treat HIV after infection — in the mid-2000s.
In its challenge filed with the U.S. Patent and Trademark Office in August, Gilead said independent researchers had already discussed the idea of using Truvada to prevent HIV by the time CDC applied for its patent.