Orders nº T-549/18 of Tribunal General de la Unión Europea, February 10, 2021

• Resolution Date: February 10, 2021
• Issuing Organization: Tribunal General de la Unión Europea
• Decision Number: T-549/18

(Removal from the register)

In Case T-549/18,

Hexal AG, established in Holzkirchen (Germany), represented by M. Martens, lawyer, S. Faircliffe, Solicitor, and N. Carbonnelle, lawyer,

applicant,

v

European Medicines Agency (EMA), represented by S. Drosos, R. Pita and T. Jabłoński, acting as Agents,

defendant,

supported by

Sanofi-Aventis Groupe, established in Paris (France), represented by P. Bogaert, B. Van Vooren and C. Ryckman, lawyers,

and

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

interveners,

APPLICATION, first, for a declaration that the plea of illegality raised against Commission Implementing Decision C(2013) 5611 final of 26 August 2013 granting marketing authorisation for ‘AUBAGIO - Teriflunomide’, a medicinal product for human use, is admissible and well-founded, in so far as that decision confirms the conclusion of the Committee for Medicinal Products for Human Use (CHMP) that teriflunomide has new active substance status and, second, pursuant to Article 263 TFEU for the annulment of the decision of the EMA of 5 July 2008, not to validate the applicant’s marketing authorisation application for a generic version of the medicinal product Aubagio.

1 The applicant, Hexal AG, brought this action by application lodged at the Court Registry on 19 September 2018.

2 By documents lodged at the Registry of the Court on 21 December 2018 and 21 January 2019, respectively, Sanofi-Aventis Groupe and the European Commission sought leave to intervene in the present proceedings in support of the form of order sought by the defendant. By orders of 18 March 2019, the President of the Eighth Chamber of the Court, having heard the main parties, granted those applications for leave to intervene. On 20 and 23 May 2019, respectively, the Commission and Sanofi-Aventis Groupe lodged their statements in intervention, on which the applicant and the defendant lodged their observations within the prescribed periods.

3 On 16 August 2019, the written part of the procedure was closed.

4 On a proposal from the Eighth Chamber, the Court decided, on 12 February 2020, pursuant to Article 28 of the Rules of Procedure, to refer the case to the Eighth Chamber sitting in extended composition of five judges.

5 The parties presented oral arguments and replied to the questions put by the Court at the hearing on 10 July 2020. After the hearing, the Court closed the oral part of the procedure and began its deliberations.

6 On 26...