ORDER OF THE PRESIDENT OF THE COURT
22 September 2022 (*)
(Appeal – Intervention – Article 40 of the Statute of the Court of Justice of the European Union – Application made by an agency of the European Union – Standing to intervene in an appeal – Interest in the result of the case – Allowed)
In Case C‑237/22 P,
APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 4 April 2022,
Mylan IRE Healthcare Ltd, established in Dublin (Ireland), represented by L. Bidaine and I. Vernimme, avocats,
appellant,
the other parties to the proceedings being:
European Commission, represented by K. Mifsud-Bonnici and A. Sipos, acting as Agents,
defendant at first instance,
VVB UAB, established in Kaunas (Lithuania), represented by V. Horcajuelo Rivera, E. Rivas Alba and M.C. Yáñez Cañas, abogados, and by M. Martens and B. Mourisse, advocaten,
intervener at first instance,
THE PRESIDENT OF THE COURT,
having regard to the proposal from K. Jürimäe, Judge-Rapporteur,
after hearing the Advocate General, N. Emiliou,
makes the following
Order
1        By its appeal, Mylan IRE Healthcare Ltd (‘Mylan’) asks the Court of Justice to set aside the judgment of the General Court of the European Union of 26 January 2022, Mylan IRE Healthcare v Commission (T‑303/16, not published, EU:T:2022:25), whereby the General Court rejected the application for annulment of Commission Implementing Decision C(2016) 2083 final of 4 April 2016 concerning, in the framework of Article 29 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for ‘Tobramycin VVB and associated names’, medicinal products for human use which contain the active substance ‘tobramycin’ (‘the decision at issue’).
2        By document lodged at the Registry of the Court on 11 July 2022, the European Medicines Agency (EMA) applied, under the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union and Article 130 of the Rules of Procedure of the Court of Justice, applicable to appeal proceedings under Article 190(1) of those rules, for leave to intervene in the present case in support of the form of order sought by the European Commission. The EMA argues that it has a direct interest in the Court upholding the decision at issue, which was adopted by the Commission on the basis of an opinion of the Committee for Medicinal Products for Human Use, which, pursuant to Article 56 of 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), is one of the committees of which the EMA is comprised.
3        By document lodged at the Registry on 29 July 2022, Mylan claimed that the Court should reject that application to intervene. It argues, in essence, first, that that application is inadmissible inasmuch as it does not comply with the time limit for making applications to intervene laid down in Article 190(2) of the Rules of Procedure. Secondly, Mylan submits that the application to intervene, made at a late stage in the judicial proceedings, should not be taken into account under Article 129(4) of the Rules of Procedure because it would not serve any meaningful purpose and would merely make the proceedings more cumbersome. Consequently, the EMA should not be permitted to participate in any court hearing under that provision either.
4        By document lodged at the Registry on 28 July 2022, the Commission indicated that it had no objection to the EMA’s application to intervene.
Whether the application to intervene is out of time
5        Article 190(2) of the Rules of Procedure provides that, by way of derogation from Article 130(1) of those rules, an application to intervene must be made within one month of the publication of the notice referred to in Article 21(4) thereof. Under Article 129(4) of those rules, consideration may be given to an application to intervene which is made after the expiry of the applicable time limit but before the decision to open the oral part of the procedure provided for in Article 60(4) thereof. In that event, if the President allows the intervention, the intervener may submit his, her or its observations during the hearing, if it takes place.
6        According to Article 21(4) of the Rules of Procedure, a notice is to be published in the Official Journal of the European Union indicating the date of entry in the register of an application initiating proceedings, the names of the parties or, as the case may be, initials replacing a name, the form of order sought by the applicant and a summary of the pleas in law and of the main supporting arguments.
7        Article 49(1)(b) of the Rules of Procedure provides that a time limit expressed in months is to end with the expiry of whichever day in the last month is the same day of the week, or falls on the same date, as the day during which the event or action from which the time limit is to be calculated occurred or took place. Article 49(2) thereof specifies that, if the time limit would otherwise end on a Saturday, Sunday or an official holiday, it is to be extended until the end of the first subsequent working day. Lastly, Article 51 of those rules provides that the procedural time limits are to be extended on account of distance by a single period of 10 days. Such is the case in relation to the time limit laid down in Article 190(2) thereof.
8        In this instance, the notice relating to the present case was published in the Official Journal of the European Union on 30 May 2022 (OJ 2022 C 213, p. 35).
9        Therefore, pursuant to Articles 49 and 51 of the Rules of Procedure, the time limit for making applications to intervene laid down in Article 190(2) of those rules expired on 11 July 2022.
10      It follows that the EMA’s application to intervene, lodged at the Registry of the Court on 11 July 2022, is not out of time.
11      Consequently, the objection that the application to intervene is inadmissible on the ground that it was submitted out of time must be dismissed, without its being necessary to examine Mylan’s arguments as to whether the present application to intervene should be taken into account under Article 129(4) of the Rules of Procedure.
Whether there is an interest in the result of the case
12      The first paragraph of Article 40 of the Statute of the Court of Justice of the European Union provides that Member States and institutions of the Union may intervene in cases before the Court. Under the first sentence of the second paragraph of that article, the same right is open to the bodies, offices and agencies of the Union and to any other person which can establish an interest in the result of a case submitted to the Court.
13      The Court must therefore determine, in the present case, whether an office or agency of the Union, such as the EMA, has an ‘interest in the result of a case’.
14      According to the Court’s settled case-law, the concept of an ‘interest in the result of a case’, within the meaning of the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union, must be defined in the light of the subject matter of the dispute and be understood as meaning a direct, existing interest in the ruling on the form of order sought, and not as an interest in relation to the pleas in law or arguments put forward. The words ‘result of a case’ refer to the final decision sought, as set out in the operative part of the future judgment. In principle, an interest in the result of the case can be regarded as sufficiently direct only in so far as that result is capable of altering the legal position of the applicant to intervene (order of the President of the Court of 17 September 2021, Germany v Pharma Mar and Commission, C‑6/21 P and C‑16/21 P, EU:C:2021:756, paragraph 9 and the case-law cited).
15      However, it should be pointed out that the bodies, offices and agencies of the Union, unlike natural and legal persons, are likely to apply for leave to intervene in a case before the Court not to defend private interests or, as in the case of associations, interests connected with the objects set out in their statutes, such as environmental protection for example, but rather where, as in the present case, the measure giving rise to the dispute was adopted following a procedure in which the body, office or agency in question was called upon to participate, in order to defend the opinion it had issued or the assessments it had made in the course of that procedure (order of the President of the Court of 17 September 2021, Germany v Pharma Mar and Commission, C‑6/21 P and C‑16/21 P, EU:C:2021:756, paragraph 10).
16      Therefore, so far as concerns applications to intervene by bodies, offices and agencies of the Union, the requirement that the applicant to intervene should have a direct and existing interest in the result of a case must be applied in a way that reflects that particular situation.
17      Thus, as regards applications to intervene in a case concerning the annulment of an EU measure, or the setting aside of a decision of the General Court dismissing an action for annulment of such a measure, made by bodies, offices and agencies of the Union, the requirement that the relevant body, office or agency should have a direct and existing interest in the result of a case should be regarded as having been met, inter alia, if it is able to establish that the EU measure at issue was adopted following a procedure in which, in accordance with EU law, its participation is envisaged through, as the case may be, the adoption of opinions or the carrying out of assessments (order of the President of the Court of 17 September 2021, Germany v Pharma Mar and Commission, C‑6/21 P and C‑16/21 P, EU:C:2021:756, paragraph 12).
18      That is the case here. It is common ground that, in the procedure for the adoption of the decision at issue, the EMA’s Committee for Medicinal Products for Human Use prepared the opinion of that agency on the clinical superiority of the medicinal product ‘Tobramycin VVB’ over the medicinal product ‘Tobi Podhaler’, an opinion which was taken into account by the Commission.
19      Consequently, in accordance with the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union and Article 131(3) of the Rules of Procedure, it is appropriate to grant the EMA leave to intervene in support of the form of order sought by the Commission.
The intervener’s procedural rights
20      Since the application to intervene has been allowed, the EMA will receive a copy of every procedural document served on the parties, pursuant to Article 131(3) of the Rules of Procedure in conjunction with Article 190(1) thereof.
21      As that application was made within the time limit laid down in Article 190(2) of the Rules of Procedure, the EMA will be permitted, in accordance with Article 132(1) of those rules, applicable to appeal proceedings under Article 190(1) thereof, to submit a statement in intervention within one month after the communication referred to in the preceding paragraph.
22      Lastly, the EMA will be permitted to submit oral observations if a hearing is organised.
Costs
23      Under Article 137 of the Rules of Procedure, applicable to appeals under Article 184(1) thereof, a decision as to costs is to be given in the judgment or order which closes the proceedings.
24      In the present case, since the EMA’s application to intervene has been granted, the costs relating to its intervention must be reserved.
On those grounds, the President of the Court hereby orders:
1.      The European Medicines Agency (EMA) is granted leave to intervene in Case C‑237/22 P in support of the form of order sought by the European Commission.
2.      A copy of every procedural document shall be served on the European Medicines Agency (EMA) by the Registrar.
3.      A period shall be prescribed within which the European Medicines Agency (EMA) may submit a statement in intervention.
4.      The costs relating to the intervention by the European Medicines Agency (EMA) are reserved.
Luxembourg, 22 September 2022.
A. Calot Escobar
K. Lenaerts
Registrar
President
*      Language of the case: English.