Mylan announces court decision that Biogen’s Tecfidera patent is invalid.

Mylan N.V. announced that the U.S. District Court for the Northern District of West Virginia invalidated Biogen’s Tecfidera patent, U.S. Patent No. 8,399,514, for lack of written description.

The ?514 patent claimed methods of treating multiple sclerosis (MS) using a dose of 480 mg/day of dimethyl fumarate delayed release capsules. THis decision clears the way for Mylan’s launch of its dimethyl fumarate product upon the receipt of FDA approval. The ‘514 patent could have otherwise delayed generic competition until 2028.