The U.S. Department of Justice has filled a suit against Gilead Sciences, Inc. charging patent infringements.. (Photo Credit: magann via Adobe Stock)

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According to a press release by the Department of Justice, Gilead Sciences, Inc. has infringed upon four U.S. patents in connection with the pharmaceutical company’s Truvada and Descovy, which are marketed to prevent HIV as part of the PrEP regimen. In the press release, Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division says the “lawsuit demonstrates the Department’s commitment to protect the government’s intellectual property and hold accountable those who seek to unfairly gain from the government’s research without paying reasonable royalties as the law requires.” The lawsuit claims that Gilead has received billions of dollars in revenue off HIV prevention regimens that were developed by Centers of Diseases Control and Prevention researchers and taxpayer contributions.

PrEP has dramatically shifted the rate of new HIV infections and is critical to the government’s efforts to end the HIV epidemic. The groundbreaking HIV-prevention drug can be exorbitant and has caused a large amount of criticism for Gilead to date. Over a dozen lawsuits have been filed against the company for purposely delaying a safer, next-generation HIV drug to increase revenues despite the alleged harmful side effects of Truvada and other antiviral medications. In what became a viral confrontation, Rep. Alexandria Ocasio-Cortez (D-NY) questioned Gilead’s CEO, Daniel O’Day, during a congressional hearing in May on why the drug cost $2,000 a month in the U.S., compared with $8 in Australia. Ocasio-Cortez charged that the patents were “owned by the public” and “we the people, developed this drug.”

Gilead has not formally responded to the lawsuit, but previously said it would donate enough Truvada annually to supply 200,000 uninsured Americans with the drug. An estimated 1 million Americans are at risk for infection, and only about 270,000 are currently taking the drug. Gilead makes more than $3 billion a year on Truvada, according to The New York Times. The company has previously claimed that the government’s patent claims are invalid.