17.7.2023

Official Journal of the European Union

C 252/67

(Case T-278/23)

(2023/C 252/80)

Language of the case: English

Parties

Applicants: Zentiva k.s. (Prague, Czech Republic), Zentiva Pharma GmbH (Frankfurt am Main, Germany) (represented by: K. Roox, T. De Meese and J. Stuyck, lawyers)

Defendant: European Commission

Form of order sought

The applicants claim that the Court should:

—declare their request for annulment admissible and well-founded;

—annul Commission Implementing Decision C(2023)3067(final) of 2 May 2023 (published on 4 May 2023) amending the marketing authorisation granted by Decision C(2014)601(final) for ‘Tecfidera — Dimethyl fumarate’, a medicinal product for human use (‘the contested decision’), as well as any later decision, to the extent that they perpetuate and/or replace that decision including any follow-up regulatory actions, in so far as they relate to the applicants;

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

Pleas in law and main arguments

In support of the action, the applicants rely on eight pleas in law.

1.First plea in law, alleging failure by the European Commission to observe the time limit for obtaining an extension of market protection as required by Article 14(11) Regulation EC No. 726/2004 of the European Parliament and of the Council. (1)

2.Second plea in law, alleging that the European Commission misapplies the law, as the Commission erred with respect to the scope of the 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) and in particular by considering the ad hoc assessment report of 11 November 2021 irrelevant.

3.Third plea in law, alleging that the European Commission made an error in basing the contested decision on the wrong scientific facts available at the time of its decision.

4.Fourth plea in law, invoking a plea of illegality against Biogen’s marketing authorisation granted by the Commission Implementing Decision C(2014)601(final) (2) and requesting the annulment of the contested decision as a consequence.

5.Fifth plea in law, alleging infringement of the fundamental rights and in particular, the right to a fair trial, the right of defence, the right to be heard, and the right to a legal basis pursuant to Article 47 of the Charter of Fundamental Rights of the European Union.

6.Sixth plea in law, alleging that the contested decision infringes the applicants’ legal certainty.

7.Seventh plea in law, alleging that the contested decision violates the applicants’ legitimate expectations.

8.Eight plea in law, alleging that the contested decision violates the applicants’ right to property, laid down in Article 17 of the Charter of Fundamental Rights of the European Union.

*

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).

*

Commission Implementing Decision C(2014)601(final) of 30 January 2014 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Tecfidera — Dimethyl fumarate’, a medicinal product for human use.