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Blockbuster PrEP Lawsuit: Gilead Wins Over U.S. Government

Blockbuster PrEP Lawsuit: Gilead Wins Over U.S. Government

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A jury favored the drugmaker against the CDC’s claims it's owed money for the preventative HIV medication.

A federal court jury in Delaware has ruled that Gilead Sciences did not violate patents held by the Centers for Disease Control and Prevention for an HIV prevention drug.

The U.S. government sued Gilead in 2019, arguing that the company was profiting off CDC patents through the sale of Truvada and Descovy, oral medications taken to prevent HIV infection. Gilead's combined worldwide sales of Truvada and Descovy were about $2 billion in 2022, according to company financial statements, and the CDC felt they were owed royalties.

However, after a multi-day trial, jurors found that the government’s patent claims on the HIV prevention regimen pre-exposure prophylaxis (PrEP) were not valid.

“Today’s decision confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP available to all who need it,” said Gilead general counsel Deb Telman in a statement, according to CNBC.

PrEP has played a vital role in helping reducing new HIV infections, particularly in higher-risk communities like men who have sex with other men. The concept of using Truvada to prevent HIV was well-known when the U.S. government filed for the patents, and Gilead claimed that it invented these drugs. However, the government argued that the CDC in the mid-2000s discovered that two drugs, emtricitabine and tenofovir, were highly effective in preventing HIV infection.

Truvada and Descovy both contain emtricitabine and tenofovir.

“Gilead will continue to champion collaborations, including our efforts with the U.S. Health and Human Services Department and CDC that span more than 15 years, as we all work together toward our common goal to end the HIV epidemic for everyone, everywhere,” Telman said.

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