BRIEF—Favorable EU court ruling for Biogen's Tecfidera

The Court of Justice of the European Union decided in favor of US biotech major Biogen, the European Medicines Agency (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 the multiple sclerosis therapy’s regulatory data and marketing protection.

Since the impact of generic copies from 2020, sales of Tecfidera have dropped from an annual level of $4.4 billion in 2019 to just $1.44 billion in 2022.

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.