- The U.S. government on Wednesday accused Gilead of illegally profiting from taxpayer-funded HIV research, suing the biotech in federal district court for infringing on patents tied to the preventive use of two HIV drugs.
- The lawsuit escalates a dispute between Gilead and the Department of Health and Human Services, which holds four patents for research done in the 2000s by the Centers for Disease Control and Prevention on pre-exposure prophylaxis HIV treatment.
- Gilead has refused to license those patents from HHS, the agency said, and in August contested their validity by requesting the U.S. Patent Office review all four patents. Gilead sells two drugs, Truvada and Descovy, for PrEP, expanding the use of which is a major component of the Trump administration's plans to reduce new HIV infections in the U.S.
The legal challenge intensifies the pressure on Gilead, which has been under fire for its pricing of Truvada (emtricitabine/tenofovir). In May, the drugmaker's new CEO Daniel O'Day was forced to defend the company in a contentious congressional hearing that spotlighted the contributions of government research to Truvada's PrEP approval.
Truvada, which is also cleared to treat existing HIV infections, is one of the most important drugs in Gilead's three-decade history, earning the drugmaker more than $30 billion since its first approval in 2004.
Sales for PrEP use don't account for all of that, but the indication is the focus of government lawyers as well as activists who charge Gilead's high prices have prevented broad access to the drug. Truvada costs roughly $1,800 a month in the U.S. at list price, more than twice as much as what it cost in 2004.
Gilead recently won Food and Drug Administration approval for PrEP use of a successor drug called Descovy, which contains emtricitabine with a new version of tenofovir. Regulators cleared the treatment for adults and teenagers at risk of sexually acquiring HIV, but notably restricted use of the drug in cisgender women at risk of infection through vaginal sex.
Descovy is similarly expensive as Truvada. As generic competitors to Truvada could arrive next year, Gilead hopes to encourage switching to Descovy, which the company says is safer.
Gilead maintains that it alone is responsible for the invention and development of Truvada. In May, O'Day said the company has spent $1.1 billion on research around the drug and its use, a claim the company repeated in a Thursday statement.
In that statement, the drugmaker said it intends to ask the district court to stay HHS' lawsuit until the Patent Office has reached a ruling on the validity of the patents.
Gilead reiterated its role in inventing and developing Truvada, and noted its "support [of] the clinical trials that led to the approval of Truvada for PrEP."
HHS, unsurprisingly, holds a different view of the part played by Gilead.
"As its PrEP sales have skyrocketed, Gilead has exaggerated its role in developing PrEP," the agency wrote in its lawsuit, filed in Delaware district court.
"In so doing, Gilead has ignored CDC's clear contributions and baselessly denied the validity of CDC's patents. Gilead's only contribution to CDC's patented research was providing samples of the drugs that CDC used for testing purposes."
In its suit, HHS is seeking damages from Gilead for alleged infringement of the CDC patents, arguing that they entitle the agency to license PrEP regimens like Truvada's and receive a royalty for its use.
"HHS's decision to sue Gilead for patent infringement on Truvada and Descovy PrEP is a necessary first step to ensure access to effective HIV prevention for everyone who needs it," said the activist group PrEP4All in a statement.
"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."
While more than one million Americans could benefit from PrEP, less than 150,000 have been prescribed the drug regimen, according to a perspective piece published in the New England Journal of Medicine last year.
In May, Gilead committed to donating enough supply of Trvuada to treat as many as 200,000 uninsured Americans at risk for the virus each year. The company also reached an agreement with Teva to permit entry of a generic version of Truvada next September, earlier than previously expected.