Gilead Defeats Federal Government Lawsuit Alleging Patent Infringement for HIV Prevention DrugsMay 11, 2023

On Tuesday, May 9, 2023, a jury found that Gilead did not infringe on three patents held by the federal government, and furthermore, that the patents at issue are invalid. The government was seeking more than $1 billion in damages related to the sale of Truvada and Descovy for an HIV prevention regimen call pre-exposure prophylaxis, or PrEP.

In the mid-2000s, Gilead’s drug Truvada was approved to treat HIV. The CDC helped fund trials to see if Truvada could also block transmission of HIV. Gilead provided free doses of Truvada and placebo pills for the experiments. The research showed that Truvada could prevent infections and trials began on human subjects.

The CDC applied for several patents related to the research, which the jury found were invalid as anticipated or obvious. Gilead also won a separate federal court ruling that the CDC breached their research contracts with Gilead by failing to notify the company of its patent applications.

Gilead marketed and sold Truvada, and later Descovy, as drugs for PrEP. The Department of Health and Human Services notified Gilead about the CDC patents and urged Gilead to enter into a licensing agreement which would include paying royalties on Truvada and Descovy to the government. Gilead declined to do so.

Companies may enter licensing agreements with the government to share profits that come from inventions developed with taxpayer-support research. In this case, that sort of an agreement was never reached, and the government sued for damages.

Gilead stated that the jury’s verdict confirmed that Gilead has always had the rights to make the drugs for PrEP. Gilead’s worldwide sales of Truvada and Descovy were about $2 billion in 2022.

Julie L. Spieker is an Intellectual Property Attorney in the MVS Biotechnology & Chemical Practice Group as well as the Mechanical and Electrical Practice Group. To learn more, visit our MVS website , or contact Julie directly via email.

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