Shire plc, announced that its subsidiary, Shire Development LLC, has prevailed in its litigation against Watson Pharmaceuticals Inc., Watson Laboratories, Inc.-Florida, Watson Pharma, Inc. and Watson Laboratories, Inc. (collectively “Watson”, now “Actavis”) in connection with their Abbreviated New Drug Application (ANDA) for a generic version of Shire’s Lialda (mesalamine) delayed release tablets for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.
Following a five day bench trial in the Southern District of Florida, Judge Middlebrooks issued a ruling upholding the validity of the patent covering Lialda, US Patent No. 6,773,720 (the “’720 patent), and holding that the proposed ANDA formulation infringes the claims of that patent. Accordingly, Judge Middlebrooks confirmed that Shire is entitled to an injunction, which he will issue separately, which prohibits the FDA from approving the ANDA formulation until the expiration of the ‘720 patent.
“Shire is very pleased that the court has ruled in our favour. We rely on our patents to be able to continue to invest in therapies that bring value to our patients and their caregivers. 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.
Shire’s Lialda remains the only once-daily mesalamine product indicated for both the induction of remission of mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. No ANDA’s have been approved for generic versions of Lialda.