Biotechnology company Biogen Inc. (BIIB) announced Thursday a favorable decision from the Court of Justice of the European Union relating to TECFIDERA (dimethyl fumarate) regulatory data and marketing protection.
The company noted that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency or EMA, and the European Commission in their appeal of a General Court decision annulling the EMA's refusal to evaluate a generic version of TECFIDERA (dimethyl fumarate) 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 said it will seek to enforce this protection and continue to enforce its EP 2 653 873 patent related to TECFIDERA, which expires in 2028.
The company noted that its fiscal 2023 financial guidance issued on February 15 assumed a favorable decision such as this in this case.
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