Action brought on 10 January 2024 – Ferring Pharmaceuticals v Commission

(Case T-12/24)

Language of the case: English

Parties

Applicant: Ferring Pharmaceuticals A/S (Kastrup, Denmark) (represented by: F. Pochart and E. Mignon, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

declare the application for annulment admissible and well-founded;

annul Commission Implementing Decision C(2023) 6669 final of 29 September 2023 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council ¹ for “Degarelix Accord – degarelix acetate”, a medicinal product for human use, in its entirety (OJ C/2023/298) ;

order the Commission to bear the costs of the proceedings.

Pleas in law and main arguments

In support of the action, the applicant relies on two pleas in law.

First plea in law, alleging that the European Commission committed a violation of essential procedural requirements by deviating from the European guidelines on bioequivalence without justification and by relying on a draft foreign guideline instead.

Second plea in law, alleging that the European Commission committed a manifest error of assessment by allowing the applicant to the generic medicinal product not to provide the necessary bioequivalence studies.

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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).