On March 16, 2022, the Federal Circuit denied Biogen's petition for rehearing of its November 2021 decision in Biogen Int'l GmbH v. Mylan Pharms., Inc., 18 F.4th 1333, 1343 (Fed. Cir. 2021), which found that Biogen's patent U.S. 8,399,514 ("the '514 patent") covering the treatment of multiple sclerosis (MS) with dimethyl fumarate (DMF, Brand name Tecfidera') invalid for lack of written description.
The core issue in the panel's 2-1 decision in November 2021 was whether the specification of the '514 patent sufficiently supported the claimed therapeutically effective DMF dose 480 mg per day (DMF480) in MS treatment. The panel majority found that the DMF480 dose was disclosed only once in the specification and only appeared at the end of a dose range among a series ranges, and held that the specification's focus on basic research and the mere disclosure of broad dosage ranges showed that the inventors did not possess the therapeutically effective DMF480 dose at the time of filing the application. The panel majority asserted that what matters in this case is whether "a skilled artisan could deduce simply from reading the...
