Sandoz Among Winners As US Court Applies Tecfidera Patent Invalidity Ruling

Delaware Court Matches Mylan West Virginia Invalidity Decision

17 Sep 2020

In infringement proceedings involving Biogen’s key Tecfidera patent expiring in February 2028, a district court in Delaware has decided that a recent West Virginia invalidity ruling applies under collateral estoppel. The decision means a host of ANDA sponsors could now press on with an “at-risk” launch, like Mylan – the recipient of the invalidity decision – did last month.

Gavel — Tecfidera ANDA sponsors have much to gain given the value of the US market • Source: Shutterstock

Further generic versions of Biogen’s Tecfidera (dimethyl fumarate) blockbuster could hit the US market after a federal district court in Delaware said it was bound by an invalidity ruling obtained by Mylan from a rival court, despite the Delaware court having previously presided over a separate trial on the patent’s validity.

Delaware district judge Maryellen Noreika concluded that a recent finding of invalidity rendered in the Northern District of West Virginia,...