Action brought on 21 September 2025 – Merck Europe v Commission

(Case T-637/25)

(C/2025/5725)

Language of the case: English

Parties

Applicant: Merck Europe BV (Amsterdam, Netherlands) (represented by: P. Bogaert, Z. Bertrand, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

—	annul the letter of the European Commission of 14 July 2025, restricting the terms of the marketing authorisation for the medicinal product Mavenclad; and

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

Pleas in law and main arguments

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

1.	First plea in law, alleging an infringement of the right to be heard, as the defendant did not grant the applicant an effective and timely opportunity to submit observations in the procedure leading to the adoption of the contested decision.

2.	Second plea in law, alleging an infringement of the duty to examine the matter carefully, as the defendant failed to consult the Committee for Medicinal Products for Human Use prior to the adoption of the contested decision, and failed to consider all factors relevant to the matter at hand.

3.	Third plea in law, alleging an infringement of the duty to provide sufficient reasoning, as the defendant failed to identify the legal basis of the contested decision, and failed to explain adequately the grounds for restricting Mavenclad’s marketing authorisation.

4.	Fourth plea in law, alleging an infringement of the principle of scientific excellence, manifest errors of assessment, and material inaccuracies, as the defendant relied on manifestly incorrect justifications for restricting the terms of Mavenclad’s marketing authorisation.

5.	Fifth plea in law, alleging an infringement of the principle of equal treatment, as the defendant treated Mavenclad differently from comparable medicinal products and in the same manner as medicinal products that are not comparable.