ORDER OF THE GENERAL COURT (Fourth Chamber)
10 April 2024 (*)
(Action for annulment – Public health – Medicinal products for human use – Decision to grant marketing authorisation for Dimethyl fumarate Mylan – dimethyl fumarate – Repeal of the contested decision – Action which has become devoid of purpose – No need to adjudicate)
In Case T‑279/22,
Biogen Netherlands BV, established in Amsterdam (Netherlands), represented by C. Schoonderbeek, lawyer,
applicant,
v
European Commission, represented by K. Mifsud‑Bonnici, A. Sipos and E. Mathieu, acting as Agents,
defendant,
supported by
Mylan Ireland Ltd, established in Dublin (Ireland), represented by C. Dekoninck, lawyer,
intervener,
THE GENERAL COURT (Fourth Chamber),
composed of R. da Silva Passos (Rapporteur), President, I. Reine and T. Pynnä, Judges,
Registrar: V. Di Bucci,
having regard to the order of 4 August 2022, Biogen Netherlands v Commission (T‑279/22 R, not published, EU:T:2022:491),
having regard to the written part of the procedure,
makes the following
Order
1 By its application based on Article 263 TFEU, the applicant, Biogen Netherlands BV, seeks annulment of Commission Implementing Decision C(2022) 3252 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 Mylan – dimethyl fumarate’, a medicinal product for human use (‘the contested decision’).
2 By document of 21 December 2023, the Commission informed the Court that, in execution of the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), it adopted Implementing Decision C(2023) 8920 final of 13 December 2023, repealing the contested decision.
3 The Commission considers that, by adopting Decision C(2023) 8920 final of 13 December 2023, and by repealing, with that decision, the contested decision, it removed the latter from the legal order. Therefore, according to the Commission, the legal effects of the contested decision having been eliminated by the adoption of Decision C(2023) 8920 final of 13 December 2023, annulment of the contested decision cannot confer any benefit on the applicant, inasmuch as such annulment would only result in the adoption of a new decision, which would essentially correspond to Decision C(2023) 8920 final of 13 December 2023.
4 In conclusion, the Commission contends that, following the adoption of Decision C(2023) 8920 final of 13 December 2023, the present action has become devoid of purpose and that there is therefore no longer any need to adjudicate on it.
5 Furthermore, the Commission requests that each party be ordered to bear its own costs.
6 By letter lodged at the Registry of the General Court on 8 January 2024, the applicant stated that it did not oppose the application for a decision that there is no need to adjudicate submitted by the Commission.
7 By letter lodged at the Court Registry on 8 January 2024, the intervener stated that it did not oppose the application for a decision that there is no need to adjudicate submitted by the Commission and requested that the applicant be ordered to pay the costs, including those incurred by the intervener.
8 Pursuant to Article 130(2) and (7) of the Rules of Procedure of the General Court, if a party so applies, the Court may declare that the action has become devoid of purpose and that there is no longer any need to adjudicate on it.
9 In the present case, since the applicant has applied for a declaration that the action has become devoid of purpose and that there is no longer any need to adjudicate on it, the Court, considering that it has sufficient information available to it from the material in the file, has decided to rule on the Commission’s request without taking further steps in the proceedings.
10 According to settled case-law, the withdrawal or, in certain circumstances, the repeal of the contested act by the defendant institution deprives the action for annulment of its purpose, since it leads, for the applicant, to the desired outcome and gives him, her or it full satisfaction (see order of 23 May 2023, CMB v Commission, T‑619/22, not published, EU:T:2023:294, paragraph 29 and the case-law cited).
11 In the present case, it must be held that, by Implementing Decision C(2023) 8920 final of 13 December 2023, the Commission repealed the contested decision. That repeal leads, for the applicant, to the desired outcome and gives it full satisfaction. Accordingly, since the applicant cannot gain any benefit, other than the one that it has already obtained by the decision to repeal the contested decision, from any annulment of that decision, it must be concluded, pursuant to Article 130(7) of the Rules of Procedure, that the present action has become devoid of purpose.
12 Furthermore, the applicant has stated that it does not oppose the application for a decision that there is no need to adjudicate submitted by the Commission.
13 In those circumstances, the action has become devoid of purpose. It follows that there is no longer any need to adjudicate on it.
Costs
14 Under Article 137 of the Rules of Procedure, where a case does not proceed to judgment, the costs are to be in the discretion of the Court.
15 Under Article 138(3) of the Rules of Procedure, the Court may order an intervener other than those referred to in paragraphs 1 and 2 to bear its own costs.
16 Neither the applicant nor the Commission has made any submissions as to the costs incurred in Mylan’s intervention proceedings.
17 The intervener, for its part, has requested the Court to order the applicant to pay the costs.
18 The Court finds that, in the particular circumstances of the case, particularly in the light of the fact that the repeal of the contested decision, by Commission Implementing Decision C(2023) 8920 final of 13 December 2023, was carried out in execution of the judgment of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), ordering the applicant and the Commission to bear their own costs, including those relating to the proceedings for interim measures, and requiring the intervener to bear its own costs relating to the application to intervene will constitute a fair application of the abovementioned provision.
On those grounds,
THE GENERAL COURT (Fourth Chamber)
hereby orders:
1. There is no longer any need to adjudicate on the action.
2. Biogen Netherlands BV and the European Commission shall bear their own costs, including those relating to the proceedings for interim measures and to the application to intervene of Mylan Ireland Ltd.
3. Mylan Ireland shall bear its own costs relating to the application to intervene.
Luxembourg, 10 April 2024.
V. Di Bucci | | R. da Silva Passos |