Sandoz Among Winners As US Court Applies Tecfidera Patent Invalidity Ruling

Delaware Court Matches Mylan West Virginia Invalidity Decision

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

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