Shire plc and its subsidiary, Shire Development LLC, announced that the United States District Court for Southern Florida has upheld its patent for 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.

The decision follows litigation by Shire 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 Lialda.

Judge Donald M. Middlebrooks issued a ruling holding that Actavis’ proposed ANDA formulation infringes US patent number 6,773,720 ('720 patent), the Orange Book listed patent for Lialda, which extends through June 8, 2020. Accordingly, Judge Middlebrooks entered an injunction prohibiting the FDA from approving the ANDA formulation until the expiration of the '720 patent and an injunction against Actavis prohibiting them from making, using, selling or importing their proposed ANDA product until after the expiration of the ‘720 patent. This is the second patent infringement trial in which the proposed ANDA product from Actavis (formerly Watson) has been found to infringe the ‘720 patent.

“Shire is very pleased that the court has once again ruled in our favour, reaffirming the validity of the patent protecting Lialda,” said James Harrington, senior vice president, global head of intellectual property, Shire. “This ruling supports the innovation and value we continue to bring to the patients who benefit from this important medicine that allows them to lead better lives.”

Shire’s Lialda remains the only once-daily mesalamine product indicated for both the induction of remission of mild to moderate ulcerative colitis and the maintenance of remission of ulcerative colitis.

Lialda is a prescription medication approved for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC.

The most common side effects reported in clinical studies of Lialda were ulcerative colitis, headache, passing gas, abnormal liver function test results, stomach ache.