2 April 2014Americas

Actavis wins Lialda generic appeal

The US Court of Appeals for the Federal Circuit has reversed a lower court decision that found Actavis’s generic version of Shire’s ulcerative colitis drug Lialda (mesalamine) infringes US patent 6,773,720.

Circuit judge Todd Hughes ruled on March 28 that the US District Court for the Southern District of Florida’s constructions of Lialda’s active ingredient’s “inner lipophilic matrix” and “outer hydrophilic matrix”, claimed in the ‘720 patent, “impermissibly broaden” the ordinary meaning of the terms.

The appeals court has referred the case to the district court for further proceedings using claim constructions consistent with its opinion.

The ‘720 patent claims a controlled-release oral pharmaceutical composition for treating inflammatory bowel diseases including Crohn’s disease and mild to moderate ulcerative colitis.

Dublin-headquartered Shire sued Actavis for patent infringement after the pharmaceutical company, also based in Dublin, filed an Abbreviated New Drug Application with the US Food and Drug Administration for approval to market a generic version of Lialda.

It told LSIPR in a statement that it "remains dedicated to defending its IP".

According to IMS Health figures quoted by Actavis, Lialda generated revenues of $576 million in the 12 months to January 31, 2014.

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