A rift between the Centers for Disease Control and Prevention and pharmaceutical giant Gilead Sciences grew Wednesday when the Trump administration sued Gilead in U.S. District Court, asserting that Gilead made billions of dollars on HIV prevention therapy while repeatedly ignoring government patents.
The patent infringement case against a major drug company, coming at a time of increasing political anger over drug prices, signals a shift in a relationship that typically has been collaborative. The San Francisco-based company has worked for years with the CDC to fight HIV, including providing free drugs for government experiments, as well as efforts to expand treatment of hepatitis C.
But the lawsuit filed on behalf of the Department of Health and Human Services this week describes how, beginning in 2015, Gilead repeatedly refused to recognize CDC patents for an HIV prevention called Truvada for PrEP.
"Gilead has repeatedly refused to obtain a license from CDC to use the patented regimens,'' the government said in its lawsuit, filed by the Justice Department in federal court in Delaware. "Meanwhile, Gilead has profited from research funded by hundreds of millions of taxpayer dollars. Indeed, Gilead has reaped billions from PrEP . . . but has not paid any royalties to CDC."
The government filed the unusual case as the Trump administration prepares an initiative to eradicate new cases of HIV and AIDS by 2030. Wider distribution of Truvada for PrEP is the linchpin of the plan.
Truvada was a combination tablet sold by Gilead beginning in 2004 to treat people already infected by HIV, the virus that causes AIDS. Meanwhile, the CDC proved in its government labs in Atlanta that Truvada could be used as a prophylactic to prevent HIV infection in monkeys. It filed patent applications, which resulted in patents being awarded to the government in 2015.
In the meantime, beginning with Food and Drug Administration approval of the prevention regimen in 2012, Gilead made billions of dollars marketing Truvada for PrEP, which is more than 96 percent effective at blocking the virus. But its high cost has been denounced by activists and members of Congress. The current price is about $20,000 a year for a single patient.
The high cost, the government said in its complaint, "is a major reason that many at risk of HIV infection in the United States are not currently taking Truvada for PrEP."
As Truvada faces generic competition next year, Gilead has recently won approval to market a newer, similar drug, Descovy, for HIV prevention. The government asserts that its PrEP patents also apply to Descovy.
The government's lawsuit follows a report 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 HIV/AIDS 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 Justice Department had opened a review of the patent.
In a news release Wednesday, HHS Secretary Alex Azar said the government filed the lawsuit to protect the public's investment in HIV prevention. "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," Azar said. "The complaint filed today seeks to ensure that they do."
The company said Thursday that it was surprised by the government's lawsuit. Gilead's stock had dropped 2.2 percent by the close of markets Thursday.
"Gilead has acted above board and in good faith to come to a resolution with HHS on the issue of the validity and ownership of the . . . PrEP patents,'' the company said in a statement. "We strongly believe that the patents granted to HHS since 2015 for PrEP . . . are not valid and reject any notion of willful infringement," it added. "HHS improperly filed for patents without alerting Gilead, despite its obligation to do so."
Gilead filed a formal challenge to the patents in August with the U.S. Patents and Trademark Office. Gilead said independent researchers had already discussed the idea of using Truvada to prevent HIV by the time the CDC applied for its patent.
A lawyer who frequently handles pharmaceutical patent issues, Chad Landmon of the firm Axinn, Veltrop and Harkrider, said the case will probably take several years to resolve, unless the parties settle.
"This is very rare," he said. "The government is sort of planting a flag on this one. Obviously the Trump administration has at times taken new and unique approaches to problems, and this is a new and unique strategy."
HIV activists said the government's move was a "first step" toward making Truvada for PrEP more widely available.
"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 Collaboration. "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."
Azar's action also won support from Capitol Hill.
"This is an important step in expanding access to HIV prevention medication," said Sen. Debbie Stabenow, D-Mich., who wrote Azar in April requesting answers about the government's Truvada for PrEP patent enforcement. "Drug companies should not be able to charge patients tens of thousands of dollars for lifesaving treatments discovered through taxpayer funded research, nor should they be allowed to infringe on government-owned intellectual property with impunity."
Gilead has pledged to provide free Truvada to help meet Trump's ambitious HIV eradication goals. HHS and Gilead said Wednesday that the dispute over the patent would not affect the pledge. The San Francisco-based company has said it will donate 2.4 million bottles per year of Truvada for PrEP to the effort. The CDC will decide where the drugs should be distributed.
This article was written by Chris Rowland, a reporter for The Washington Post.