Gilead Takes Over Federal Authorities For HIV Drug Patents

Gilead Takes Over Federal Authorities For HIV Drug Patents

Introduction

Manufacturers of HIV drug Truvada, Gilead Sciences, filed a lawsuit against the U.S. government, alleging that the U.S. Centers for Disease Control and Prevention (CDC) violated a contract, governing the collaboration on HIV drug, between the company and government agency.

According to the lawsuit filed, the manufacturer indicated that the U.S. government violated four Material Transfer Agreements (MTAs) and a Clinical Trial Agreement between the company and the CDC. Gilead initially received approval from the FDA for the use of drugs combined with other treatments. However, as per the lawsuit, in the early 2000s, researchers at CDC created new regimens, patented by the U.S. government, to prevent the spread of HIV.

Last year, in November 2019, the U.S. Department of Justice filed a lawsuit, claiming that the government spent hundreds of millions of dollars on clinical studies, and Gilead profited by selling the drugs at highly inflated prices.

The recent case is the latest rift between the federal government and Gilead, over who owns the patent for the HIV drug.

Along with the legal dispute with the Justice Department, Gilead is also facing an increasing number of complaints filed by plaintiffs nationwide, alleging side effects of tenofovir disoproxil fumarate (TDF) infused HIV drugs like Truvada, Stribild, and other medications.