District court again sides with Shire in Lialda dispute

The U.S. District Court of Southern Florida upheld a patent protecting ulcerative colitis drug Lialda mesalamine from Shire plc (LSE:SHP; NASDAQ:SHPG) and granted an injunction blocking approval and sale of a generic form of the drug from Allergan plc (NYSE:AGN) until the patent expires in 2020. It is the only Orange Book-listed patent for Lialda.

Shire had alleged that an ANDA submitted by Watson Pharmaceuticals Inc., which is now part of Allergan, infringed its U.S. Patent No. 6,773,720. The same district court had found in favor of Shire in 2013 as well. The case was twice appealed, to the U.S. Court of Appeals for the Federal Circuit (CAFC) and the U.S. Supreme Court, but it was remanded back to the district court on jurisdictional grounds (see BioCentury Extra, June 5, 2015). ...