Mylan Triumphs In Tecfidera Patent Challenge
Biogen's Tecfidera Future Uncertain After Patent Challenge Loss To Mylan
Following a district court decision invalidating the '514 patent for Tecfidera, Mylan says it looks forward to launching a generic after final FDA approval is granted, despite Biogen saying it will appeal the ruling. The ANDA has a November action date.
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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.
As anticipated by the street, Viatris has prevailed over Biogen on the originator’s appeal of a district court ruling that invalidated a key US patent shielding its Tecfidera treatment for multiple sclerosis. However, the Federal Circuit was not aligned on its decision.
With a federal district court decision opening the door for a multitude of generic Tecfidera products, the market has reacted, suggesting as many as five ANDA products are primed for launch.