Judge Rules Mylan Infringed Shire’s Patent on Ulcerative Colitis Drug

A federal judge validated Shire’s patent on its delayed-release Lialda, ruling that Mylan infringed two of the patent’s claims when seeking to launch a generic of the bowel disease drug.

U.S. District Judge Charlene Honeywell for the Middle District of Florida granted Shire a permanent injunction that prohibits Mylan from marketing a Lialda generic before the reference drug’s patent expires in 2020. The ruling follows a four-day bench trial held in September.

Mylan’s generic formulation “seeks to ‘piggyback’” on Lialda by using the same active ingredient and dissolution profile as the reference drug. The evidence — including Mylan’s own admission that its generic contains 5- amino-salicylic acid, the active ingredient in Lialda — shows direct infringement, the judge wrote.