Acorda patent challenge and restructuring news

The U.S. District Court for the District of Delaware invalidated four of the five Orange Book-listed patents protecting Acorda’s multiple sclerosis drug Ampyra dalfampridine on grounds of obviousness. Acorda said it plans to appeal the decision. The four invalidated patents -- U.S. Patent Nos. 8,007,826; 8,663,685; 8,354,437; and 8,440,703 -- covered use of a 10 mg dose of the formulation to treat walking impairments in MS patients. The court upheld one Ampyra patent, U.S. Patent No. 5,540,938, which expires in July 2018. It covers use of a sustained-release formulation of 4-aminopyridine (4-AP).

Acorda filed the suit in 2014 alleging that several generics manufacturers, including Apotex Inc. (Toronto, Ontario), the Roxane Laboratories Inc. subsidiary of Hikma Pharmaceuticals plc (LSE:HIK, London, U.K.), Mylan N.V. (NASDAQ:MYL; Tel Aviv:MYL, Canonsburg, Pa.) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA, Petah Tikva, Israel), infringed the five patents...