Federal Court Denies Biogen’s Appeal Over Tecfidera Patent

A federal appeals court has upheld Mylan’s challenge to a Biogen patent covering the latter’s blockbuster multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate).

The Biogen patent was deemed invalid because it failed to properly describe how the drug treats the debilitating neurological disease, the U.S. Court of Appeals for the Federal Circuit ruled, affirming a June 2020 decision by the U.S. District Court for the Northern District of West Virginia.

The appeals court ruling has serious implications for Biogen’s bottom line. Tecfidera is a top-selling drug for the company, as is its successor MS drug Vumerity, with the two therapies accounting for revenue of $3.9 billion in 2020.

But sales for both drugs dropped significantly last year, from $4.4 billion in 2019, and revenues are expected to decrease further as more generic competitors enters the MS market.