Case T-520/24: Action brought on 7 October 2024 – CSL Behring v Commission and EMA
Date: 2024-10-07
Institutions: General Court
Subjects: drug surveillance, maladministration, market approval, orphan drug, rights of the defence








C_202407042EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/7042


2.12.2024






Action brought on 7 October 2024 – CSL Behring v Commission and EMA


(Case T-520/24)

(C/2024/7042)
Language of the case: English

Parties


Applicant: CSL Behring GmbH (Marburg, Germany) (represented by: G. Morgan and C. Drew, Solicitors)

Defendants: European Commission and European Medicines Agency

Form of order sought

The applicant claims that the Court should:






—


Annul Commission Implementing Decision (2024)5447 of 24 July 2024 granting a conditional marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004
                   (1) for ‘Durveqtix – fidanocogene elaparvovec’;










—


order the Commission and/or the EMA to pay the costs of the proceedings.





Pleas in law and main arguments

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






1.


First plea in law, alleging that the defendants have breached the duty to provide reasons in respect of the assessment of similarity as a result of which the applicant, as the holder of an orphan market exclusivity right under Article 8(1) of the Orphan Regulation, (2) is directly and adversely affected.










2.


Second plea in law, alleging that the defendants have breached the applicant’s rights to procedural fairness and the fundamental principle of good administration guaranteed by Article 41 of the Charter of Fundamental Rights in respect of:






—


The assessment of ‘unmet need’ for the purposes of Article 4(1)(c) of Commission Regulation (EC) No 507/2006 of 29 March 2006, (3) insofar as the EMA failed (i) to adhere to the requirements identified in the EMA Guidelines, (ii) to provide the applicant with a right to be heard in relation to proceedings culminating in a measure adversely affecting it; and










—


The assessment of ‘similarity’ for the purposes of Article 8(1) of the Orphan Regulation, insofar as the defendants failed to provide the applicant with a right to be heard.














3.


Third plea in law, alleging ultra vires/lack of competence in relation to the reasoning of the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Advanced Therapies (CAT) on unmet medical need as found in the European Public Assessment Report (EPAR).










4.


Fourth plea in law, alleging that the defendants fell into manifest error in their substantive assessment of both unmet medical need and similarity.






(1)  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).

(2)  Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1).

(3)  Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ 2006 L 92, p. 6).


ELI: http://data.europa.eu/eli/C/2024/7042/oj
ISSN 1977-091X (electronic edition)