Gilead Sciences settles patent disputes with Lupin, Cipla and 3 others over HIV, Hepatitis B drugs generic versions

Generic drugmakers Apotex Inc, Lupin Ltd, Cipla Ltd, Macleods Pharmaceuticals Ltd and Hetero Labs Ltd will receive non-exclusive licenses to the patents, allowing them to sell generic versions of the HIV drugs starting in October 2031 and Vemlidy in January 2032, according to the filing.

The filing did not disclose additional settlement details, but said the licenses could begin earlier "in certain circumstances."

A spokesperson for Gilead said the company was pleased with the resolution. A representative for Apotex and attorneys for Lupin and Cipla declined to comment Monday.

The other companies and their attorneys did not immediately respond to requests for comment.

The disclosure came the same day a bench trial was scheduled to begin on Gilead's claims in Delaware federal court. Gilead told U.S. District Judge Maryellen Noreika that it had resolved the cases in a series of filings between Thursday and Sunday.

Foster City, California-based Gilead sold nearly $1.4 billion of Descovy, over $1 billion of Odefsey, and over $380 million of Vemlidy in the United States last year.

Gilead sued the drugmakers for infringement after they requested U.S. Food and Drug Administration approval for their proposed generics. The company requested a ruling that its patents were valid and an order to block the generics until they expired.

The generic drugmakers argued that the patents were invalid and unenforceable. They said in an August court filing that Gilead's patents covered "routine and predictable" variants of a "compound it did not invent."

The drugmakers said in the filing that Gilead's patents would have improperly maintained its monopoly on the drugs until August 2032.

The case is Gilead Sciences v. Apotex Inc, U.S. District Court for the District of Delaware, No. 1:20-cv-00189.

For Gilead: Juanita Brooks of Fish & Richardson

For Apotex: Stephen Auten, Richard Ruzich and Ian Scott of Taft Stettinius & Hollister

For Lupin: William Zimmerman, Jonathan Bachand and Andrea Cheek of Knobbe Martens Olson & Bear

For Macleods: Neal Seth and Adrienne Kosak of Wiley Rein

For Cipla: Jefferson Boggs, Christopher Sorenson, and Andrew Larsen of Merchant & Gould

For Hetero: Dennies Varughese and Joseph Kim of Sterne Kessler Goldstein & Fox