Official Journal of the European Union

C 338/26

(Case T-256/23 R)

(Interim relief - Medicinal products for human use - Marketing authorisation - Application for interim measures - Application for injunction - Lack of urgency)

(2023/C 338/35)

Language of the case: English

Parties

Applicant: Mylan Ireland Ltd (Dublin, Ireland) (represented by: K. Roox, T. De Meese, J. Stuyck and C. Dumont, lawyers)

Defendant: European Commission (represented by: E. Mathieu, L. Haasbeek and A. Spina, acting as Agents)

Re:

By its application based on Articles 278 and 279 TFEU, the applicant seeks, in essence, first, suspension of operation of Commission Implementing Decision C(2023) 3067 final of 2 May 2023 amending Commission Implementing Decision C(2014) 601 final of 30 January 2014 granting marketing authorisation (‘MA’) for the medicinal product for human use Tecfidera — Dimethyl fumarate under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1), as amended, and any subsequent decision or act extending or replacing the contested decision in so far as they concern it, and, second, an injunction requiring the European Commission to refrain from taking any other measures which would amount to a withdrawal of the MA enjoyed by it or a prohibition on placing generic Dimethyl fumarate products on the market.

Operative part of the order

1.The application for interim measures is dismissed.

2.There is no longer any need to rule on the application to intervene submitted by Biogen Netherlands BV or on the application for confidential treatment submitted by Mylan Ireland Ltd.

3.The costs relating to the proceedings for interim relief are reserved.

4.Each party shall bear its own costs relating to the application to intervene submitted by Biogen Netherlands.