WASHINGTON — The U.S. government and Department of Health and Human Services filed a patent infringement lawsuit against Gilead Sciences on Wednesday.
HHS made the announcement in a press release.
“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,” said HHS Secretary Alex M. Azar II. “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.”
Both Truvada and Descovy have been approved by the FDA for use in pre-exposure prophylaxis (PrEP) for HIV prevention.
The department said that Gilead got approval to market and distribute the drugs, but has never gotten licenses for the patents, which are held by HHS.
The United States Patent and Trademark Office granted four patents to HHS that protect CDC’s work and the taxpayers’ investment. These patents entitle HHS to license CDC’s PrEP regimens and receive a reasonable royalty for their use. Two other companies that manufacture generic equivalents of Truvada for PrEP in foreign countries have agreed to licenses with HHS.