Biogen: win in EU court for TECFIDERA
(CercleFinance.com) - Biogen announced today that the Court of Justice of the European Union has ruled in favour of Biogen, the European Medicines Agency (EMA), and the European Commission in its appeal of a Court of First Instance decision annulling the EMA's refusal to evaluate a generic version of TECFIDERA on the grounds of regulatory data protection and marketing.
With this favourable ruling, Biogen believes that TECFIDERA is entitled to regulatory marketing protection in the European Union until at least 4 February 2024. Biogen will seek to enforce this protection and will continue to enforce its patent EP 2 653 873 related to TECFIDERA, which expires in 2028.
Biogen's FY 2023 financial guidance published on 15 February 2023 assumed a favorable decision, as is the case here.
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With this favourable ruling, Biogen believes that TECFIDERA is entitled to regulatory marketing protection in the European Union until at least 4 February 2024. Biogen will seek to enforce this protection and will continue to enforce its patent EP 2 653 873 related to TECFIDERA, which expires in 2028.
Biogen's FY 2023 financial guidance published on 15 February 2023 assumed a favorable decision, as is the case here.
Copyright (c) 2023 CercleFinance.com. All rights reserved.