US Government Seeks New Judgment, Trial After Gilead’s HIV PrEP Victory

scales of justice_iStock, BrianAJackson

Pictured: Gavel and scales of justice/iStock, BrianAJackson

Wednesday, the U.S. government requested that a federal judge overturn a May decision in which a jury ruled Gilead’s HIV prevention medicines Truvada and Descovy did not infringe on government patents. The government is seeking both a new judgment and a new trial, according to Bloomberg Law.

On May 9, a Delaware jury ruled in favor of the California–based biopharma company, also deciding that the government’s patents in question were invalid.

In its lawsuit, the Trump administration, through the Department of Human and Health Services, claimed that the two-drug regimen was first invented and proposed for prophylaxis by researchers at the Centers for Disease Control and Prevention in the early 2000s and that Gilead had overstated its role in the invention, according to STAT News.

Gilead, for its part, maintained that using Truvada to prevent HIV was well-known by the time the government sought the patents, STAT reported. 

The jury found that Gilead was able to show “clear and convincing evidence” that all three patent claims were invalid.

Truvada was first approved for HIV pre-exposure prophylaxis (PrEP) in 2012. Descovy, an upgraded version of Truvada, was approved for the same purpose in October 2019. A month later, the government filed its lawsuit over these approvals. 

“Gilead has received billions of dollars in revenue from HIV prevention regimens invented by HHS researchers and patented by the United States,” Assistant Attorney General Jody Hunt of the Department of Justice’s civil division said in a statement at the time, adding that the action demonstrated the DOJ’s commitment to protecting the government’s intellectual property. The government was seeking royalties from Gilead, which it said refused to obtain a license from CDC, even as it brought in more than $10 billion in sales, according to Bloomberg Law.

Legal experts said this was the first time the U.S. government had launched a patent infringement suit against a pharmaceutical company, according to STAT.

The cost of the medicines appears to be the primary issue for the patient advocacy group PrEP4All and legal representatives, who wrote in a May 30 letter to HHS and the U.S. Attorney General that “long-overdue royalties paid by Gilead for its infringement would also provide resources to mitigate the significant harms caused by Gilead’s wanton and flagrant disregard of the wellbeing and health of marginalized communities...” The preventative medicines cost over $20,000 per patient per year, according to the authors.

Descovy earned Gilead just over $1.6 billion in U.S. revenue in 2022, while Truvada brought in $113 million, according to the company’s fourth-quarter and full-year earnings report.

Heather McKenzie is a senior editor at BioSpace, focusing on neuroscience, oncology and gene therapy. You can reach her at Follow her on LinkedIn and Twitter@chicat08

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