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to Section One | to Arts & Entertainment
posted Friday, November 8, 2019 - Volume 47 Issue 45
Feds sue Gilead over PrEP patents
Section One
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Feds sue Gilead over PrEP patents

by Mike Andrew - SGN Staff Writer

Federal attorneys filed suit on November 8 against Gilead Sciences, the pharmaceutical giant that makes and markets PrEP medications Truvada and Descovy.

According to the lawsuit, Gilead infringed on patents owned by the federal Department of Health and Human Services (HHS), and refused attempts by HHS to license its patents and collect royalties.

Gilead's HIV-prevention drugs can cost patients up to $20,000 a year. The government lawsuit accuses the company of earning billions from research funded by US taxpayers without paying taxpayers back.

Gilead makes more than $3 billion a year on Truvada. HHS says hundreds of millions of dollars in taxpayer money went into research that led to the government patents.

'Gilead must respect the US patent system, the groundbreaking work by CDC [Centers for Disease Control and Prevention] researchers, and the substantial taxpayer contributions to the development of these drugs,' HHS Secretary Alex M. Azar II said in a statement. 'The complaint filed today seeks to ensure that they do.'

Wider access to PrEP is central to the government's goal, announced in February, to reduce new HIV infections by 75% over five years, and to 'end the HIV epidemic in America' by 2030.

HIV activists say the price tag of PrEP medications limits accessibility for high-risk people with low incomes, thwarting efforts to control the disease.

In May, Gilead said it would donate enough PrEP medications to supply 200,000 patients with the drug for up to 11 years. Some one million Americans are estimated to be at risk for infection, and only about 270,000 people are currently on PrEP.

PrEP4All, an activist group that has pushed for wider access to medications, called the government lawsuit 'a necessary first step to ensure access to effective HIV prevention for everyone who needs it.'

'For nearly a decade, Gilead's price gouging on PrEP has prevented hundreds of thousands of Americans from accessing this life-saving medication, despite it being a taxpayer-funded invention,' the group said in a statement.

'If HHS is truly invested in ending the HIV epidemic, it will use these patents as leverage to ensure that everyone who needs PrEP can get it.'

Gilead has not responded to the lawsuit with a statement. The company previously characterized the government's patent claims as invalid.

In Africa, generic Truvada costs about $60 per patient per year. Gilead has sued companies that have tried to bring generic versions to the United States. Settlements to those legal actions have effectively kept the generic drug out of the US market.

Descovy, approved by the FDA in October, contains a newer version of tenofovir, the active ingredient in Truvada. Gilead has been marketing it as a replacement for Truvada, but so far it has been tested only in men and Trans women. For final approval, the FDA will require the company to study the drug on cisgender women.

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Feds sue Gilead over PrEP patents
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