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Viatris Celebrates As US Court Refuses Tecfidera Review

Originator Biogen Is ‘Disappointed With Decision’ And ‘Evaluating Next Steps’

 
• By Dave Wallace

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.

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The US Court of Appeals for the Federal Circuit has refused to rehear the litigation

Another option has been exhausted for Biogen in its continued pursuit of a reversal in US litigation over Tecfidera (dimethyl fumarate), after the US Court of Appeals for the Federal Circuit decided in a split ruling not to rehear litigation with Viatris. Biogen had petitioned the court for both a panel rehearing and a rehearing “en banc” before the entire bench.

A 2-1 split decision by the appeals court had late last year confirmed an earlier patent invalidity ruling that allowed generics to launch in 2020. (Also see "Federal Circuit Cements Viatris Victory Over Biogen On Key US Tecfidera Patent" - Generics Bulletin, 1 December, 2021

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