Sucampo Pharmaceuticals, Inc. today announced that it, its affiliate Sucampo AG, R-Tech Ueno, Ltd., Takeda Pharmaceutical Company Limited (Takeda), and certain affiliates of Takeda have filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Anchen Pharmaceuticals, Inc., Par Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc. (collectively, Anchen) related to an Abbreviated New Drug Application (ANDA) that Anchen filed with the U.S. Food and Drug Administration (FDA) to market a generic version of AMITIZA ® (lubiprostone) oral capsules, 8 mcg and 24 mcg. The lawsuit claims infringement of six patents that are listed in the FDA’s Orange Book and that are scheduled to expire between 2020 and 2027.
Sucampo commenced the lawsuit within 45 days from the receipt of a Notice letter sent by Anchen, dated December 26, 2012, regarding its filing of its ANDA. Under the Hatch-Waxman Act, as a result of the patent infringement lawsuit, final FDA approval of Anchen’s ANDA will be stayed up to 30 months from the January 2, 2013 date of receipt of the Notice letter.
“Sucampo’s patent estate for AMITIZA ® is strong, and the company intends to vigorously defend our intellectual property. We believe that the AMITIZA ® patents, granted by the US Patent & Trademark Office, are valid, enforceable, and infringed by Anchen’s proposed lubiprostone products,” said Thomas J. Knapp, Executive Vice President, Chief Legal Officer, and Corporate Secretary of Sucampo.