Дело T-***/**: *****************, Определение от **.**.2022 г.

Текст

... lpharma – dimethyl fumarate – Application for suspension of operation of a measure – No urgency)

In Case T‑269/22 R,

Biogen Netherlands BV, established in Badhoevedorp (Netherlands), represented by C. Schoonderbeek, lawyer,

applicant,

v

European Commission, represented by L. Haasbeek and A. Sipos, acting as Agents,

defendant,

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order

1. By its application based on Articles 278 and 279 TFEU, the applicant, Biogen Netherlands BV, seeks suspension of the operation of Commission Implementing Decision C(2022) 3253 final of 13 May 2022 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Dimethyl fumarate Polpharma – dimethyl fumarate’ as a medicinal product for human use (‘the contested decision’).

Background to the dispute and forms of order sought

2. The applicant is a biotechnology company which develops and markets various medicinal products, including medicinal products used in the treatment of multiple sclerosis.

3. On 28 February 2012, Biogen Idec Limited lodged with the European Medicines Agency (EMA) an application for marketing authorisation, pursuant to Article 4(1) of 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), for the medicinal product for human use Tecfidera – dimethyl fumarate (‘Tecfidera’), indicated for the treatment of multiple sclerosis.

4. On 30 January 2014, the European Commission ...