Sumitomo Dainippon Pharma Co., Ltd filed patent infringement lawsuits jointly with its U.S. subsidiary, Sunovion Pharmaceuticals Inc. (“Sunovion”) on February 13, 2018 (U.S. Eastern Time) in the U.S. District Court for the District of New Jersey against Emcure Pharmaceuticals Ltd. and in the U.S. District Court for the District of Delaware against Amneal Pharmaceuticals LLC regarding their submissions of Abbreviated New Drug Applications (“ANDAs”) for generic copies of LATUDA® (lurasidone HCl tablets). The lawsuits allege infringement of Sumitomo Dainippon Pharma’s U.S. Patent No. 9,815,827 (“the ’827 Patent”). These lawsuits are separate and different from the pending lawsuits, filed on January 14, 2015 in relation to Sumitomo Dainippon Pharma’s U.S. Patent No. 5,532,372.
Sumitomo Dainippon Pharma has granted Sunovion an exclusive license in the United States under the ’827 Patent, and Sunovion has been marketing lurasidone HCl tablets in the United States under the brand name LATUDA® since its launch in February 2011.
Sumitomo Dainippon Pharma and Sunovion continue to believe that our patent portfolio for LATUDA® is very strong and that we will continue to vigorously protect our patent rights for LATUDA®
The lawsuits will not materially affect Sumitomo Dainippon Pharma’s consolidated financial results of the fiscal year ending March 31, 2018. As to the financial impacts for the fiscal year ending March 31, 2019 and thereafter, we will make announcement as they become available. Given the above, it has been decided that the originally scheduled March 8, 2018 announcement of the new Mid-term Business Plan for the five fiscal years starting from fiscal year beginning April 1, 2018 is postponed.
