Gilead ratchets up its Truvada patent fight with U.S. in new breach-of-contract lawsuit

Gilead Sciences sued the Department of Health and Human Services for breach of contract in the latest development in the patent dispute between the drugmaker and the U.S. government. (Gilead China)

Gilead Sciences and federal authorities have been locked in a high-stakes fight over patents on an HIV prevention drug, and now Gilead has filed the latest salvo. In a new lawsuit, the Big Biotech claims the U.S. secured its patents by breaching contracts with the company.

Gilead sued the federal government Friday in the Court of Federal Claims, claiming the Centers for Disease Control and Prevention (CDC) violated four material transfer agreements and one clinical trial agreement.

The agreements between the company and the agency “governed the terms of the more than 15-year collaboration” between the parties on HIV prevention drugs, and Gilead says the government violated terms of the deals by seeking its own patents.

Specifically, Gilead says the federal government sought patent protections for HIV prevention drug Truvada without notifying the company as it was required to do. Under the agreements, Gilead says, the company provided “significant” drug quantities to federal researchers “free of charge” for trials. The government was in turn responsible for notifying the company if it made any discoveries. The clinical trial agreement specified that U.S. officials wouldn’t seek to patent the work, according to the suit.

Gilead says the Department of Health and Human Services (HHS) in 2006 “improperly” filed for patent protections and didn’t notify the company. Patent officials granted the HHS a series of four patents starting in 2015, covering the use of Gilead’s medicines for HIV prevention. Now, the HHS is suing Gilead for violations of those patents, which Gilead maintains are invalid. 

The CDC didn't respond to a request for comment.

RELATED: Gilead loses again in PrEP patent fight with HHS, sending dispute to federal court 

It’s the latest in a back-and-forth between the parties, which have traded jabs since at least last year. Gilead sought to challenge the patents at the U.S. Patent and Trademark Office, but those petitions fell short.

But meanwhile, Gilead and HHS are also partners in a free drug distribution program after Gilead’s sizable donation agreement last year. And as the COVID-19 pandemic plays out, the company said it’s committed to helping in that response. Gilead’s remdesivir is among the most promising drug candidates against COVID-19, though recent early data for the med have raised questions about its efficacy.

Gilead is seeking a declaration from the court that the government breached the contracts, plus damages. The company says it’s had to pay attorney fees so far as part of the patent disputes and has suffered reputational harm.