Actavis plc (NYSE: ACT) today confirmed that the United States Court of Appeals for the Federal Circuit has reversed a lower court ruling that Actavis' generic version of Shire's Lialda® (mesalamine extended-release tablets) infringes United States Patent No. 6,773,720 (the '720 Patent).
The Appeals Court found that the U.S. District Court for the Southern District of Florida did not correctly construe the claims of the '720 Patent, and remanded the case to the District Court for further proceedings using claim constructions consistent with the Appeals Court's ruling.
Actavis' Abbreviated New Drug Application for its generic version of Lialda® is currently pending with the U.S. Food and Drug Administration (FDA).
Lialda® is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC. For the 12 months ended January 31, 2014 total U.S. sales of Lialda® were approximately $576 million, according to IMS Health.