United States Files Patent Infringement Lawsuit Against Gilead Related to Truvada® and Descovy® for Pre-exposure Prophylaxis of HIV

Cross-posted from U.S. Department of Health and Human Services

[Yesterday] the United States, on behalf of the Department of Health and Human Services, filed a complaint in federal district court against Gilead Sciences, Inc. and Gilead Sciences Ireland UC (collectively, Gilead) seeking damages for Gilead’s infringement of HHS patents related to pre-exposure prophylaxis (or PrEP) for HIV prevention. Despite multiple attempts by HHS to license its patents, Gilead has refused. In the complaint, HHS alleges that Gilead has willfully and deliberatively induced infringement of the HHS patents. The complaint further alleges that, as a result of such infringement, Gilead has profited from research funded by hundreds of millions of taxpayer dollars and reaped billions from PrEP through the sale of Truvada® and Descovy®.

Gilead manufactures, markets, and sells Truvada® and Descovy® for PrEP. Originally, Gilead obtained FDA approval for the use of those products for post-infection HIV treatment in combination with other drugs. But after the Centers for Disease Control and Prevention’s (CDC) groundbreaking PrEP work and subsequent human trials, Gilead also obtained FDA approvals for Truvada®, and more recently Descovy®, to be used as PrEP regimens. Gilead now markets and sells Truvada® and Descovy® for use as the PrEP regimens that HHS has patented. Nevertheless, Gilead has repeatedly refused to obtain licenses for the use of the HHS patents.

“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.”

Since the beginning of the AIDS epidemic in the early 1980s, researchers worldwide sought drug-based strategies to effectively prevent the spread of HIV. For over two decades, none succeeded. During that time, over 25 million people died due to AIDS.1 And the number of people living with HIV reached its highest level—about 40.3 million people.2

In the mid-2000s, researchers at the CDC succeeded where others had not. These scientists developed innovative two-drug regimens to effectively prevent HIV infection. This type of regimen is known as PrEP.

Numerous human PrEP trials have confirmed that, when used as directed, the PrEP regimens invented by CDC are 99% effective in preventing HIV infection in at-risk patients. Hundreds of millions of taxpayer dollars funded many of these trials.

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.

The claims asserted against Gilead are allegations only, there has been no determination of liability.

Footnotes

1. UNAIDS, AIDS Epidemic Update: Special Report on HIV Prevention 2 (Dec. 2005), available at https://data.unaids.org/publications/irc-pub06/epi_update2005_en.pdf - PDFExit Disclaimer.
2. Id.