Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection
Biogen (Nasdaq: BIIB) announced a favorable ruling from the Court of Justice of the European Union regarding the regulatory marketing protection for its drug TECFIDERA (dimethyl fumarate). The court's decision upheld Biogen's position that TECFIDERA is entitled to regulatory protection in the EU until at least February 4, 2024, and reinforced its patent rights, which expire in 2028. This outcome aligns with Biogen's previously issued 2023 financial guidance. The company remains proactive in defending its intellectual property and advancing its extensive pipeline of therapies across various medical areas.
- Court ruling supports TECFIDERA's regulatory marketing protection until at least February 4, 2024.
- Strengthened patent enforcement for TECFIDERA, expiring in 2028.
- Aligns with previously issued 2023 financial guidance.
- None.
CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in favor of 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 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.
About Biogen
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.
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| MEDIA CONTACT: Biogen Jack Cox + 1 210 544 7920 public.affairs@biogen.com | INVESTOR CONTACT: Biogen Mike Hencke +1 781 464 2442 IR@biogen.com |
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