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.
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Biogen has conceded that generics to its Tecfidera treatment for relapsing remitting multiple sclerosis may launch “at risk” in the EU, after the US-based player was recently granted further patent protection until 2028.
Viatris has welcomed a decision by the US Court of Appeals for the Federal Circuit not to rehear litigation with Biogen over Tecfidera, after a split decision by the court last year confirmed a patent invalidity ruling that allowed generics to launch in 2020. Biogen told Generics Bulletin it was disappointed with the decision and is evaluating its next steps.
In 2021, courts across the US and beyond continued to weigh key patent litigation fights, alongside the thorny issue of induced infringement via label carve outs and controversial charges for generic price fixing.