Drugmaker Gilead Sciences said Thursday it remained "committed" to working with the federal government on curbing the HIV epidemic despite a new lawsuit alleging it infringed on government patents with its HIV-prevention drugs.
HHS sued Gilead on Wednesday claiming it willfully infringed on the Centers for Disease Control and Prevention's 2015 patent for Truvada and Descovy as a pre-exposure prophylaxis treatment. The U.S. Food and Drug Administration approved Truvada in 2012 for PrEP and Descovy last month. They are the only medications approved for preventing HIV infection.
Gilead pledged in May to donate more than two million doses of its pre-exposure prophylaxis drug Truvada to help achieve the Trump administration's goal of ending the HIV epidemic in the U.S. by 2030.
"Despite this patent dispute, Gilead will continue to work collaboratively with federal agencies, including HHS and CDC, on efforts to end the HIV epidemic in the United States," the company said in a statement Thursday. "We remain committed to supporting the government's efforts to substantially increase the number of people at risk for HIV who have access to PrEP through our historic donation and through our own ongoing efforts to address the social and structural barriers to care."
HHS did not respond to requests for comment on Thursday.
HHS Secretary Alex Azar on Wednesday recognized Gilead's role in getting PrEP to market, saying it has led to saving lives and reducing the spread of HIV. But he said the government was forced to sue after the drugmaker refused the agency's "multiple attempts" to license its patents.
"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 government claims the CDC conducted most of the research that led to Truvada's discovery as a pre-exposure prophylactic. The center applied for a patent to use Truvada's for PrEP in 2006, which was awarded in 2015, one of the four patents the federal government has on the drugs.
But Gilead contended the patents are invalid because it had the idea of using the drug pre- and post-exposure first. The drugmaker is challenging the patents.
"The fact remains that Gilead invented Truvada and funded the clinical trials that led to its 2004 FDA approval for use in combination with other antiretroviral agents to treat HIV," the company said. "The company has spent an estimated $1.1 billion on R&D related to Truvada—any claim to the contrary is false."
HIV activists praised the government for suing Gilead, although some were critical of HHS for not taking action sooner. Truvada sales generated nearly $3 billion in 2018 alone, according to Gilead's financial statements.
Critics have blamed Gilead for limiting access to Truvada for PrEP by making it cost prohibitive to those who need it most or are at greatest risk of HIV infection. The cost of Truvada has gone up from an average list price of $1,391 a month in 2012 to $2,100 a month.
In 2015, 90,000 prescriptions for PrEP were filled compared to the 1.1 million Americans estimated that would have benefited from taking the medication, according to the CDC's most recent figures. The most at-risk populations for HIV infection—African American and Latino adults—made up only 14,000 of Truvada prescriptions filled that year despite accounting for nearly three-fourths of those at risk.
"HHS' decision to sue Gilead for patent infringement on Truvada Descovy PrEP is a necessary first step to ensure access to effective HIV prevention for everyone who needs it," said the PrEP4All Coalition, a patient advocacy organization.
Christopher Morten, a teaching fellow at New York University School of Law's Engelberg Center on Innovation Law and Policy who has represented PrEp4All in past litigation, said he was hopeful the money that the government might receive from Gilead stemming from the litigation would be used to expand access to PrEP and treatment in the most heavily affected areas of the country.
"This is an opportunity for HHS and CDC to expand the work that they do now on preventing HIV in the United States and caring for people with HIV," Morten said. "I think the most important thing now is for all of us to keep the pressure on HHS to use its patents strategically."
