IP Law Daily, PATENT NEWS: Jury clears Gilead’s HIV prevention drugs of infringing U.S. government patents, (May 10, 2023)

By Cheryl Beise, J.D.

The jury also found that the asserted claims of the government patents were invalid.

A federal jury in Wilmington, Delaware, has determined that Gilead Sciences’ HIV prevention treatment drugs Truvada and Descov did not infringe three patents owned by the U.S. government. The jury additionally found that each of the asserted patent claims were invalid as both anticipated and obvious. The patents relate to HIV prevention treatment known as pre-exposure prophylaxis, or PrEP, using the anti-retroviral active compounds emtricitabine and tenofovir. The lawsuit drew a great deal of attention when filed because the Government rarely sues to enforce its patents, much less to recoup a portion of profits earned by a pharmaceutical company it had partnered with (United States v. Gilead Sciences, Inc. May 9, 2023).

The lawsuit arose out of a ten-year collaboration between California-based biopharmaceutical manufacturer Gilead Sciences and the Centers for Disease Control and Prevention (CDC) to research methods of prevent HIV virus transmission. Between 2015 and 2019, CDC researchers obtained four U.S. patents—U.S. Patents Nos. 9,044,509, 9,579,333, 9,937,191, and 10,335,423—each entitled, “Inhibition of HIV infection through chemoprophylaxis.” The patents all claim priority to a provisional patent application filed in February of 2006. The patents cover PrEP therapy treatment methods using combinations of the anti-retroviral compounds emtricitabine and tenofovir. The advantage of invention is to reduce adverse side effects of treatment. The patents are owned by the U.S. Department of Health and Human Services (HHS).

In 2004, the Food and Drug Administration (FDA) approved Gilead’s Truvada drug for the treatment of HIV infections. In 2012, Gilead received approval to sell Truvada as a PrEP regimen. In April 2016, Gilead obtained FDA approval to sell Descovy for the treatment of HIV infections. In October 2019, Gilead received FDA approval to sell Descovy as a PrEP regimen. Both Truvada and Descovy include the active compounds emtricitabine and tenofovir.

In November 2019, the U.S. Government filed the present suit against Gilead Sciences Inc. and Gilead Sciences Ireland UC (collectively, “Gilead”) The complaint alleged that Gilead directly infringed and induced infringement of the four government’s patents by selling Descovy and Truvada as a PreEp treatment without obtaining a license. According to the Government, Gilead’s only contribution to CDC’s patented research was providing samples of the drugs that CDC used for testing purposes.

Only three claims of three patents remained in suit at the time of trial: claim 13 of the ’333 patent; claim 18 of the ’191 patent; and claim 18 of the ’423 patent. The jury found that Gilead did not infringe any of the four claims. The jury also determined that all four claims were invalid because they were anticipated and because they would have been obvious over prior art. Claim 18 of the ’423 patent was also found invalid for lack of enablement.

In a statement, Gilead said it was pleased with the verdict recognizing its independent creation of its Truvada and Descovy. “Gilead will continue to champion collaborations, including our efforts with the U.S. Health and Human Services Department (HHS) and Centers for Disease Control and Prevention (CDC) that span more than 15 years, as we all work together toward our common goal to end the HIV epidemic for everyone, everywhere,” the company said.

The case is No. 1:19-cv-02103-MN.

Attorneys: Lena A. Yueh, U.S. Department of Justice, for the United States. Frederick L. Cottrell, III (Richards, Layton & Finger, PA) for Gilead Sciences, Inc. and Gilead Sciences Ireland UC.

Companies: Gilead Sciences, Inc.; Gilead Sciences Ireland UC

MainStory: TopStory Patent DelawareNews GCNNews