Case T-703/20: Order of the General Court of 25 October 2024 – Mylan Ireland v EMA (Action for annulment – Public health – Medicinal products for human use – Action for annulment – Plea of illegality – Act not open to challenge – Hypothetical act – Manifest inadmissibility – Withdrawal of the claim seeking annulment of the contested decision – Action which has become devoid of purpose – No need to adjudicate)
Date: 2024-10-25
Institutions: General Court
Subjects: drug surveillance, generic drug, legality, market approval








C_202500070EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/70


6.1.2025






Order of the General Court of 25 October 2024 – Mylan Ireland v EMA


(Case T-703/20)
                (1)

(Action for annulment - Public health - Medicinal products for human use - Action for annulment - Plea of illegality - Act not open to challenge - Hypothetical act - Manifest inadmissibility - Withdrawal of the claim seeking annulment of the contested decision - Action which has become devoid of purpose - No need to adjudicate)
(C/2025/70)
Language of the case: English

Parties


Applicant: Mylan Ireland Ltd (Dublin, Ireland) (represented by: C. Dekoninck, lawyer)

Defendant: European Medicines Agency (represented by: S. Drosos and H. Kerr, acting as Agents)

Intervening parties, in support of the defendant: European Commission, (represented by: L. Haasbeek, E. Mathieu and A. Spina, acting as Agents), Biogen Netherlands BV (Amsterdam, Netherlands) (represented by: C. Schoonderbeek, lawyer)

Re:

By its action, in the form of order sought as it now stands, the applicant asks the Court, first, to declare admissible and well founded a plea of illegality raised against 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 (OJ 2014 C 59, p. 1; ‘the implementing decision of 30 January 2014
            ’) in so far as, in that implementing decision, the European Commission considers that the medicinal product for human use Tecfidera – dimethyl fumarate (‘Tecfidera’) is not covered by the same global marketing authorisation as the medicinal product for human use Fumaderm and, second, to declare that any decision subsequent to the ad hoc report of the Committee for Medicinal Products for Human Use (CHMP) of 11 November 2021 on the therapeutic function of monoethyl fumarate salts in Fumaderm relying on the opinion of 21 November 2013 of that same committee, according to which Tecfidera has different active substance status resulting in a new global marketing authorisation, must be regarded as void.

Operative part of the order







1.


There is no longer any need to adjudicate on the action in so far as concerns the head of claim seeking annulment of the decision of the European Medicines Agency (EMA) of 1 October 2020, with reference EMA/CHMP/512737/2020.










2.


The action is dismissed as manifestly inadmissible in so far as it raises a plea of illegality against the opinion of the Committee for Medicinal Products for Human Use of 21 November 2013, according to which the medicinal product for human use Tecfidera – dimethyl fumarate has a different active substance status resulting in a new global marketing authorisation, as quoted in 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.










3.


The action is dismissed as manifestly inadmissible in so far as it is directed against any decision subsequent to the ad hoc report of the Committee for Medicinal Products for Human Use of 11 November 2021 on the therapeutic function of monoethyl fumarate salts in the medicinal product for human use Fumaderm relying on the opinion of 21 November 2013 of that same committee, according to which the medicinal product for human use Tecfidera – dimethyl fumarate has a different active substance status resulting in a new global marketing authorisation, as quoted in Commission Implementing Decision C(2014) 601 final.










4.


Mylan Ireland Ltd, the European Medicines Agency (EMA), the European Commission and Biogen Netherlands BV shall bear their own costs.






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            OJ C 35, 1.2.2021.


ELI: http://data.europa.eu/eli/C/2025/70/oj
ISSN 1977-091X (electronic edition)