Federal Government Sues Gilead Over HIV PrEP Patents

Published on November 11, 2019 by Sandy Liebhard

The United States government has filed suit against Gilead Sciences, Inc., alleging certain HIV drug patents actually belong to the nation’s taxpayers.

““HHS recognizes Gilead’s role in selling Truvada and Descovy to patients for prevention of HIV.  Communities have put these drugs to use in saving lives and reducing the spread of HIV,” said Health & Human Services (HHS) Secretary Alex Azar II.  “However, Gilead must respect the U.S. patent system, the groundbreaking work by CDC researchers, and the substantial taxpayer contributions to the development of these drugs. The complaint filed today seeks to ensure that they do.”

About Gilead’s HIV PreP Patents

According to a complaint now pending in Delaware Federal Court, Gilead is allegedly infringing on four government patents for Truvada (emtricitabine and tenofovir disoproxil fumarate) and Descovy (emtricitabine and tenofovir alafenamide).  Both drugs are indicated for pre-exposure prophylaxis (PrEP) to prevent the transmission of HIV, the virus that causes AIDS.

The U.S. Centers for Disease Control (CDC) received patents for emtricitabine and tenofovir in 2006. The newly filed lawsuit contends that Gilead relied on the CDC’s research in its application to the U.S. Food & Drug Administration (FDA) for Truvada approval.

The company has since generated about $3 billion from from sales of Truvada and stands to make at least as much from Descovy, which received FDA approval for PrEP last month. Gilead claims that the new drug is less likely to cause kidney damage or bone loss compared to Truvada.

Earlier this year, Gilead requested that HHS’s PrEP patents be cancelled, arguing other researchers had already suggested using emtricitabine and tenofovir for HIV prevention. Gilead has also sued any generic drug maker that’s tried to enter the PrEP market, reaching secret out-of-court settlements – pay-for-delay deals — with every single one.

Government’s PrEP Lawsuit Represents Major Policy Reversal

The federal government’s decision to take Gilead to court over its PrEP patents is a significant reversal from the position taken just months ago.

This past May, Gilead and HHS announced the company would donate enough Truvada to cover 200,000 patients for up to 11 years. Four months later, HHS awarded the company a $6 million contract to distribute donated Truvada and Descovy to 4,000 needy people.

But critics pointed out that 4,000 people didn’t come close to meeting the overall need for PrEP, noting that Gilead already had a program that has provided Truvada free of charge to about 20,000 people each year.

“I’m very confused about who except Gilead is benefiting from this arrangement,” Jeremiah Johnson, a project director at Treatment Action Group, told The New York Times.

A lawsuit like this is highly unusual. But the federal government has set a goal of eradicating HIV by 2030, something which won’t be accomplished unless PrEP becomes much more affordable. Right now, Truvada and Descovy each cost about $20,000 per year.

If the suit is successful, HHS could be due billions of back royalties from Gilead. The government could also use the litigation as leverage to force Gilead to lower prices on Truvada and Descovy as part of any settlement.

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