Gilead Sciences Inc. (NASDAQ: GILD) is being sued by the federal government over the patent rights to Truvada, Gilead’s HIV prevention drug. The lawsuit, filed in U.S. District Court for the District of Delaware by the Department of Health and Human Services, alleges that the government owns the PrEP, or pre-exposure prophylaxis, patent for both Truvada and Descovy, Gilead’s next generation PrEP approved last month.
The lawsuit alleges Gilead contributed nothing more than donated Truvada tablets to multimillion-dollar human trials, which were mainly funded by the U.S. government and philanthropic donors. The studies were sponsored by the CDC, the National Institute of Allergy and Infectious Diseases and the Bill and Melinda Gates Foundation. CDC researchers discovered the proper dosage, used proprietary animal modeling techniques, and painstakingly recreated the environment of sexual transmission in macaques. The combined public and philanthropic funding was $29 million to $62 million per year, while funding from Gilead was up to $2 million per year.
HHS Secretary Alex M. Azar II said in a statement, “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. 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.”
In response, Gilead says that the government’s patent claims are “invalid.” The company said in a statement, “We are surprised that the government has requested that a district court judge and jury look at the same issues of patent validity that the Patent Office will be deciding. We will be asking the district court to stay the litigation until the Patent Office has an opportunity to undertake the review that we already have requested.”