Biogen receives favorable court ruling on TECFIDERA

Biogen announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency, and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA because of TECFIDERA’s regulatory data and marketing protection. With this favorable decision, Biogen believes that TECFIDERA is entitled to regulatory marketing protection in the European Union until at least February 4, 2024. Biogen will seek to enforce this protection and continue to enforce its EP 2 653 873 patent related to TECFIDERA, which expires in 2028. Biogen’s Full Year 2023 Financial Guidance issued on February 15, 2023, assumed a favorable decision such as this in this case.