Official Journal of the European Union

EN

C series

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C/2025/1546

17.3.2025

(Case T-18/25)

(C/2025/1546)

Language of the case: English

Parties

Applicant: Apellis Europe BV (Amsterdam, Netherlands) (represented by: A. Koyuncu, V. Sturla and M. Aretz, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

—declare the action admissible and well founded;

—annul the Commission Decision C(2024) 9160 final of 16 December 2024, addressed to the Applicant and refusing marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) for ‘Syfovre – Pegcetacoplan’ (the ‘Contested Decision’); and,

—order the European Commission to pay the applicant’s costs.

Pleas in law and main arguments

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

1.First plea in law, alleging the infringement of Articles 10(1) and 12(2) of Regulation 726/2004 by proceeding with the decision-making process after the withdrawal of a Marketing Authorisation (MA) application. It is clear from the wording of Articles 10 and 12 that a Commission decision can only be adopted when there is still a pending application for an MA. This is confirmed by (i) the basic principles of EU pharmaceutical law, (ii) the case law of the CJEU as shown by Case C-477/11 P, Sepracor Pharmaceuticals (Ireland) v Commission (2), and (iii) other Commission precedents where the Commission did not adopt a formal decision in similar situations of withdrawn applications. EU law does not authorise nor oblige the Commission to adopt a formal decision on an MA application after the applicant withdraws the application.

2.Second plea in law, alleging the infringement of Article 41 of the Charter of Fundamental Rights of the European Union and the general legal principle of the right to be heard. The Commission refused to forward the applicant’s submissions of 8 and 27 November 2024 to the members of the Standing Committee on Medicinal Products for Human Use, denying the applicant’s right to present arguments.

(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) Order of 14 May 2012, Sepracor Pharmaceuticals (Ireland) v Commission (C-477/11 P, not published, EU:C:2012:292).

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ELI: http://data.europa.eu/eli/C/2025/1546/oj

ISSN 1977-091X (electronic edition)

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