24.7.2023

EN

Official Journal of the European Union

C 261/39

(Case T-299/23)

(2023/C 261/54)

Language of the case: German

Parties

Applicant: Hexal AG (Holzkirchen, Germany) (represented by: A. Meier, lawyer)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

—annul the contested decision; and

—order the European Commission to pay the costs of the proceedings.

Pleas in law and main arguments

The action, which is directed against Commission Implementing Decision [C(2023) 3067 final] of 2 May 2023 amending the marketing authorisation granted by Decision C(2014) 601 final for ‘Tecfidera — Dimethyl fumarate’, a medicinal product for human use, relies on two pleas in law.

By its first plea, the applicant submits that there has been a clear infringement of Article 14(11) of Regulation (EC) No 726/2004 (1) because the authorisation in respect of the new therapeutic indication of Tecfidera was not obtained during the first eight years after the granting of authorisation, but only at a later point in time.

By its second plea, the applicant submits that there has been a manifest error of assessment in the interpretation of the judgment of the European Court of Justice in joined cases C-438/21 P to C-440/21 P (2) and, as a result, the Commission has erred in law in concluding that Tecfidera does not belong to the global marketing authorisation of Fumaderm.

(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) Judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma, C-438/21 P to C-440/21 P, EU:C:2023:213.