Lawsuit Filed Against Gilead Over HIV PrEP Patents

Lawsuit Filed Against Gilead Over HIV PrEP Patents

Introduction

The U.S. government has sued Gilead Sciences over HIV PrEP patents claiming that the patents belong to the Department of Health and Human Services, and the manufacturers are using it without paying royalties.

According to a complaint, Gilead allegedly violated four government patents for Truvada (emtricitabine and tenofovir disoproxil fumarate) and Descovy (emtricitabine and tenofovir alafenamide), which are meant for pre-exposure prophylaxis (PrEP) to prevent the transmission of HIV. The lawsuit states that the manufacturer relied on the U.S. Centers for Disease Control's  (CDC) research for the approval of Truvada by the U.S. Food & Drug Administration (FDA) for Truvada approval. CDC, previously received patents for emtricitabine and tenofovir in 2006.

Gilead is facing Allegations including, that the manufacturer failed to warn about their tenofovir disoproxil fumarate HIV medication Truvada, Viread, Atripla, Complera, and Stribild led to kidney problems and bone loss. The lawsuits are consolidated under MDL-2881, IN RE: Tenofovir Disoproxil Fumarate Products Liability Litigation, filed on December 19, 2018, in the Judicial Panel on Multidistrict Litigation.

Tenofovir Disoproxil Fumarate (TDF) is an orally administered prodrug of tenofovir. Tenofovir is similar to Adefovir, which is used for the treatment of HIV and chronic hepatitis B virus infections. Gilead Sciences Inc. originally developed it under the brand name Viread, tenofovir disoproxil fumarate, or TDF. Gilead sells five different TDF brand name drugs in the United States, and the drug also comes in generic form.