Shire Development LLC, a subsidiary of Shire Plc (SHPG,SHP.L) Thursday said it has won its patent litigation against Watson in connection with their abbreviated new drug application for a generic version of Shire's LIALDA.
After a five-day bench trial in the Southern District of Florida, the judge issued a ruling upholding the validity of the patent and said that Watson's proposed ANDA formulation infringes the claims of that patent.
Accordingly, Shire is entitled to an injunction which prohibits the FDA from approving the ANDA formulation until the expiration of the patent.
Shire's LIALDA is a mesalamine product indicated for both the induction of remission of mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.
"This ruling supports the innovative therapies that we develop in order to improve the lives of ulcerative colitis patients, " stated Roger Adsett, head of Shire's GI Business Unit.
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