Sumitomo Dainippon and Sunovion file patent infringement law suits for Latuda

Japanese pharma company Sumitomo Dainippon (TYO: 4506) and its US subsidiary Sunovion Pharmaceuticals have jointly filed patent infringement law suits against Emcure Pharmaceuticals and InvaGen Pharmaceuticals.

The law suits concern Emcure and InvaGen’s submissions of Abbreviated New Drug Applications for their generic copies of Latuda (lurasidone) tablets, approved to treat bipolar depression, on which Sunovion and Sumitomo Dainippon allege infringement.

The US Food and Drug Administration will halt the approval of the ANDAs at least until April 28, 2018 (plus an additional six months if Sunovion is awarded an exclusivity extension in pediatrics) or the date of a district court decision finding the patent invalid, unenforceable or not infringed, whichever is sooner. The law suits specifically allege infringement of Sumitomo Dainippon Pharma’s US Patent No 5,532,372.