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Court maintains patent protection for ulcerative colitis drug Lialda
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Shire has won its patent infringement trial against Watson regarding Lialda delayed-release tablets for induction and maintenance treatment of ulcerative colitis, according to a company press release.
The patent suit was filed by Shire against Watson Pharmaceuticals Inc., Watson Laboratories, Inc.-Florida, Watson Pharma, Inc. and Watson Laboratories, Inc. (now Actavis, collectively), regarding the company’s Abbreviated New Drug Application (ANDA) for a generic version of Lialda (mesalamine, Shire).
The United States District Court for Southern Florida upheld Shire’s patent, ruling that Actavis’ proposed formulation infringes on it, and accordingly, that the FDA cannot approve the ANDA formulation until the patent expires, and that Actavis cannot make, use, sell or import their proposed ANDA product until the patent expires. As a result, Shire’s patent will extend through June 8, 2020.
This is the second trial ruling that this proposed ANDA product infringes on Shire’s patent, according to the press release.
“Shire is very pleased that the court has once again ruled in our favor, reaffirming the validity of the patent protecting Lialda,” James Harrington, Senior Vice President, Global Head of Intellectual Property, Shire, said in the press release.
Disclosure: Harrington is employed by Shire.