On October 25, 2024, the European Patent Office (EPO) Opposition Division upheld the validity of Biogen Inc.'s patent EP 2 653 873, which is related to its multiple sclerosis drug, TECFIDERA® (dimethyl fumarate). This patent, which claims treating relapsing remitting multiple sclerosis using dimethyl fumarate dosed at 480 mg per day, is set to expire in February 2028.
The 480 mg per day dosage is the European Medicines Agency (EMA) recommended maintenance dose for TECFIDERA. This decision by the EPO is subject to appeal to the EPO's Technical Boards of Appeal, and the patent's validity can also be challenged in individual European Union countries. TECFIDERA is expected to have regulatory marketing protection in the EU until February 3, 2025.
This favorable patent decision is important for Biogen as it helps to protect the revenue stream from one of its established multiple sclerosis treatments against generic competition. TECFIDERA is a widely prescribed oral medication for relapsing MS globally, with over 600,000 patients treated and more than 1,400,000 patient-years of exposure.
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