ORDER OF THE PRESIDENT OF THE NINTH CHAMBER OF THE GENERAL COURT
20 April 2026 (*)
( Intervention – Time limit for intervention – Out of time – Refusal )
In Case T‑18/25,
Apellis Europe BV, established in Amsterdam (Netherlands), represented by A. Koyuncu, V. Sturla and M. Aretz, lawyers,
applicant,
v
European Commission, represented by E. Mathieu and A. Spina, acting as Agents,
defendant,
makes the following
Order
1        By its action under Article 263 TFEU, the applicant, Apellis Europe BV, seeks the annulment of the European Commission’s Implementing Decision C(2024) 9160 final of 16 December 2024, refusing marketing authorisation for the medicinal product for human use ‘Syfovre – Pegcetacoplan’ under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1), as amended.
2        By a document lodged at the Registry of the General Court on 11 February 2026, the European Confederation of Pharmaceutical Entrepreneurs (Eucope) applied for leave to intervene in the present case.
3        Under the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union, applicable to the proceedings before the General Court pursuant to the first paragraph of Article 53 thereof, any natural or legal person establishing an interest in the result of a case submitted to the General Court, save in cases between Member States, between EU institutions or between Member States and EU institutions, may intervene in that case.
4        Nevertheless, under Article 143(1) of the Rules of Procedure of the General Court, an application to intervene must be submitted within six weeks of publication in the Official Journal of the European Union of the notice initially recording the lodging of the application initiating proceedings in the case concerned, as referred to in Article 79 of the Rules of Procedure. In accordance with Article 60 of the Rules of Procedure, that time limit is, in addition, to be extended on account of distance by a single period of 10 days.
5        In the present case, the publication in the Official Journal of the European Union referred to in Article 79 of the Rules of Procedure took place on 17 March 2025.
6        It follows that, pursuant to the provisions referred to in paragraph 4 above and in accordance with the rules for calculating time limits laid down in Article 58 of the Rules of Procedure, the time limit for filing an application to intervene in the present proceedings expired on 8 May 2025.
7        Consequently, the application to intervene, lodged on 11 February 2026, was submitted after the expiry of the time limit laid down in the Rules of Procedure.
8        In that regard, it must be borne in mind that the time limit laid down in Article 143(1) of the Rules of Procedure is a matter of public policy and is not within the discretion either of the parties or indeed that of the court (see order of 5 July 2018, Müller and Others v QH, C‑187/18 P(I), not published, EU:C:2018:543, paragraph 19 and the case-law cited).
9        Furthermore, it is settled case-law that no derogation from the application of the European Union’s rules on procedural time limits may be made save where the circumstances are quite exceptional, in the sense of being unforeseeable or amounting to force majeure, in accordance with the second paragraph of Article 45 of the Statute of the Court of Justice of the European Union, since the strict application of those rules serves the requirements of legal certainty and the need to avoid any discrimination or arbitrary treatment in the administration of justice (see order of 1 August 2022, Soudal and Esko-Graphics v Magnetrol and Commission, C‑74/22 P(I), EU:C:2022:632, paragraph 69 and the case-law cited).
10      According to settled case-law, the concept of force majeure or unforeseeable circumstances, which corresponds to exceptional circumstances, contains both an objective element relating to abnormal circumstances extraneous to the person concerned, and a subjective element involving the obligation of that person concerned to guard against the consequences of the abnormal event by taking appropriate steps without making unreasonable sacrifices (see order of 12 July 2022, Cipla Europe v EUIPO and Glaxo Group, C‑245/22 P(I), not published, EU:C:2022:549, paragraph 35 and the case-law cited).
11      Thus, the applicant for leave to intervene, in the same way as the applicant, must pay close attention to the course of the procedure set in motion and, in particular, demonstrate diligence in order to comply with the prescribed time limits. Those concepts of ‘unforeseeable circumstances’ and ‘force majeure’ do not apply to a situation in which, objectively, a diligent and prudent person would have been able to take the necessary steps before the expiry of the period prescribed for instituting proceedings or for applying for leave to intervene (see, to that effect, order of 11 June 2020, GMPO v Commission, C‑575/19 P, not published, EU:C:2020:448, paragraph 34 and the case-law cited).
12      In the present case, in the first place, it must be noted that, in its application to intervene, Eucope did not expressly rely on the existence of unforeseeable circumstances or force majeure within the meaning of the case-law cited in paragraphs 9 to 11 above.
13      In the second place, nor does it appear that the circumstances relied on by Eucope to explain the lodging of its application to intervene at this stage of the proceedings constitute unforeseeable circumstances or force majeure within the meaning of that case-law.
14      In that regard, Eucope claims that new factual and procedural elements have come to light after the expiry of the time limit laid down in the Rules of Procedure, which highlight the significance of the legal issues raised by the present case for the entire pharmaceutical and biotechnological sector of which Eucope’s members form part.
15      Eucope submits that its decision to apply to intervene in the present case follows the disclosure of a series of internal documents communicated to the applicant pursuant to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43) and subsequently forwarded to Eucope in its capacity as an association representing small and medium-sized pharmaceutical and biotechnology enterprises operating within the European Union.
16      According to Eucope, it appears from those documents that there is a disagreement between the Commission, the European Medicines Agency and several Member States concerning the rights of applicants for marketing authorisations and the legal consequences of the withdrawal of an application for marketing authorisation under the centralised procedure.
17      However, it should be emphasised that, in the absence of events that constitute unforeseeable circumstances or force majeure within the meaning of the case-law cited in paragraphs 9 to 11 above, the fact, assuming it is established, that Eucope’s interest in intervening became apparent after the expiry of the six-week time limit laid down in Article 143(1) of the Rules of Procedure cannot justify disapplying that time limit (see, to that effect, orders of 5 July 2018, Müller and Others v QH, C‑187/18 P(I), not published, EU:C:2018:543, paragraph 22, and of 4 November 2025, Communauté d’Agglomération du Boulonnais v Commission, T‑582/23 RENV, not published, EU:T:2025:1033, paragraph 20).
18      In any event, it should be noted that, from the notice published in the Official Journal of the European Union referred to in Article 79 of the Rules of Procedure, it is apparent that the applicant relied, by its first plea, on an infringement of Article 10(1) and Article 12(2) of Regulation No 726/2004, in that the Commission had adopted a formal decision on its application for a marketing authorisation for Syfovre, even though that application had been withdrawn.
19      Thus, Eucope was already in a position to ascertain, at that stage, that the pleas in law and arguments set out in the notice published in the Official Journal of the European Union raised questions of principle concerning the legal consequences of the withdrawal of an application for marketing authorisation. In those circumstances, the fact that Eucope decided to apply for leave to intervene only at a later stage in the proceedings cannot be justified by the allegedly belated discovery of its interest in bringing proceedings. In accordance with the case-law cited in paragraph 11 above, the concepts of ‘unforeseeable circumstances’ and ‘force majeure’ do not apply to a situation in which, objectively, a diligent and prudent person would have been able to take the necessary steps before the expiry of the period prescribed for instituting proceedings or for applying for leave to intervene.
20      Consequently, Eucope has not demonstrated the existence of unforeseeable circumstances or force majeure such as to allow a derogation from the time limit in question on the basis of the second paragraph of Article 45 of the Statute of the Court of Justice of the European Union, which applies to proceedings before the General Court by virtue of Article 53 of that statute.
21      The application to intervene must therefore be dismissed, without it being necessary to serve it on the main parties.
Costs
22      Under Article 144(6) of the Rules of Procedure, if the application to intervene is refused, the order must include a decision as to the costs relating to the application to intervene, including the costs of the applicant for leave to intervene, pursuant to Articles 134, 135 and 138 of those rules.
23      As the present order has been made before the application to intervene has been served on the main parties and before those parties could have incurred any costs, it is appropriate to order that Eucope bear its own costs.
On those grounds,
THE PRESIDENT OF THE NINTH CHAMBER OF THE GENERAL COURT
hereby orders:
1.      The application to intervene in Case T‑18/25, lodged by the European Confederation of Pharmaceutical Entrepreneurs (Eucope), is refused.
2.      Eucope shall bear its own costs.
Luxembourg, 20 April 2026.
V. Di Bucci
S. Kingston
Registrar
President
*      Language of the case: English.