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ARTICLE · 15 DECEMBER 2021

Patent Case Summaries | Week Ending December 3, 2021

A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.

United StatesIntellectual Property

A weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.


Biogen International GmbH, et al. v. Mylan Pharmaceuticals Inc., No. 2020-1933 (Fed. Cir. (N.D. W.Va.) Nov. 30, 2021). Opinion by Reyna, joined by Hughes. Dissenting opinion by O'Malley.

The Federal Circuit affirmed the district court's determination that the claims of a Biogen patent are invalid for lack of written description.

Biogen's patent is directed to a method of treating multiple sclerosis (MS) with a drug called dimethyl fumarate (DMF), and the pertinent claims require a therapeutically effective amount of about 480 mg/day (DMF480). Mylan filed an Abbreviated New Drug Application seeking to manufacture, use, and market a generic DMF product for the treatment of MS. Biogen then sued Mylan for infringement.

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