Mylan ‘Likely To Win’ On US Tecfidera Challenge
Verdict In Litigation Is Expected By 20 June
Mylan was shot down in February this year by the USPTO after challenging Biogen’s key US patent 8,399,514 protecting Tecfidera. However, the ANDA sponsor has been backed by Bernstein to prevail in separate district court proceedings, clearing a path to potential market entry years earlier than otherwise anticipated.
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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.
Having developed a novel bioequivalent alternative to Biogen's Tecfidera brand through the FDA's 505(b)(2) pathway, Banner Life Sciences has defended itself, with success, against claims that its product infringed a key method-of-use patent shielding the multi-billion-dollar multiple-sclerosis brand.
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.