Mylan enjoined from bringing Lialda generic to market

Mylan's plans to bring a generic version of Shire's bowel disease drug Lialda (mesalamine) to market were shut down when a  district court judge held that the action would infringe Shire's patent.

The decision by the US District Court for the Middle District of Florida was handed down on Friday, January 27, after a four-day bench trial held in September last year.  Shire filed suit alleging patent infringement after Mylan filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration.  Mylan was seeking approval to market a generic of Lialda, which is protected by US patent number 6,773,720.  Following the suit, Mylan filed counterclaims for a declaratory judgment that the patent was not infringed.  In the decision, the district court permanently enjoined Mylan from bringing the generic to market.  The district court said in its decision that "Shire has established a preponderance of the evidence that Mylan's ANDA product" infringes claims of the '720 patent. Shire told LSIPR that it "is pleased with the favourable decision that was issued by the court regarding Lialda". The company added: "No ANDA's for a generic version of Lialda have been approved. Shire will continue to vigorously defend its patents to protect the innovation and value Shire products bring to patients."