Biogen's Tecfidera Safe Following IPR Decision – For Now
Tecfidera accounts for nearly one-third of Biogen's revenues, so the patent decision relieves one overhang for the company. However, other ANDA challenges are ongoing.
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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.
Mylan is aiming to be a first mover on generic Tecfidera (dimethyl fumarate), a brand with $3.3bn of sales last year, after successfully invalidating a key US patent shielding the multiple-sclerosis treatment until 2028. However, Biogen has procured a temporary injunction for now, as it seeks to defend its position on appeal.
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.