FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

HHS Hits Gilead With Patent Infringement Suit Over PrEP Drugs

Nov. 19, 2019

The Department of Health and Human Services slapped Gilead with a patent infringement suit in a federal court over its HIV drugs Truvada and Descovy.

The lawsuit in the U.S. District Court for Delaware alleges that Truvada (emtricitabine / tenofovir) and Descovy (emtricitabine and tenofovir alafenamide) infringed on four patents that the Centers for Disease Control and Prevention (CDC) owns on the pre-exposure prophylaxis (PrEP) regimens.       

Truvada was approved in 2012 for use as a PreP regimen, and Descovy was approved in October 2019 as a PrEP regimen. Both drugs were originally approved to treat HIV in conjunction with other medications.

HHS alleges that Gilead has refused to get a license to use the patents despite the department’s multiple attempts to license them. The department further alleges that because Gilead has profited from PrEP without paying royalties, it has “willfully and deliberately” infringed on the patents.

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