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Case T-327/23: Action brought on 9 June 2023 — Biogen Netherlands v Commission
ECLI:EU:UNKNOWN:62023TN0327
62023TN0327
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Valentina R., lawyer
14.8.2023
Official Journal of the European Union
C 286/32
(Case T-327/23)
(2023/C 286/43)
Language of the case: English
Parties
Applicant: Biogen Netherlands BV (Amsterdam, Netherlands) (represented by: C. Schoonderbeek and B. Jong, lawyers)
Defendant: European Commission
Form of order sought
The applicant claims that the Court should:
—annul the decision of the European Commission, the Defendant, of 15 February 2023 (C(2023)1211 (final)) granting marketing authorisation under Regulation (EC) No 726/2004 (1) for ‘Dimethyl Fumarate Accord — dimethyl fumarate’, a medicinal product for human use; and,
—order the Commission to pay the costs.
Plea in law and main arguments
In support of the action, the applicant relies on a single plea in law, alleging incorrect interpretation of the concept of the global marketing authorisation as laid down in Article 6(1), second subparagraph, of the Directive (2) and application of this concept to the medicinal products Tecfidera and Fumaderm leading to the incorrect conclusion in the Contested Decision that, at the relevant time, regulatory data protection for Tecfidera had already expired.
(1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004, L 136, p. 1).
(2) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001, L 311, p. 67).