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Federal Circuit Cements Viatris Victory Over Biogen On Key US Tecfidera Patent

US Appeals Court Split 2-1; Analyst Predicts ‘Case Is Likely Concluded’

 
• By Dean Rudge

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.

Court of Appeals for Federal Circuit Lafayette Park Across from White House Washington DC
The Federal Circuit did not overturn the June 2020 decision • Source: Shutterstock

A US district court in West Virginia “did not clearly err” in determining that Biogen’s key US patent 8,399,514 shielding its multiple sclerosis treatment Tecfidera (dimethyl fumarate) through 2028 was invalid for lack of written description, the US Court of Appeals for the Federal Circuit has ruled, cementing victory for ANDA sponsor Viatris’ Mylan.

“We hold that the district court did not clearly err in determining that Mylan has established its burden of showing, by clear and convincing evidence, that the asserted ’514 patent claims are invalid for lack of written description,” the Federal Circuit decided

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