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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Apellis Europe v Commission (Interim relief - Medicinal products for human use - Marketing authorisation for Syfovre - Pegcetacoplan - Order) [2025] EUECJ T-18/25_CO (04 April 2025) URL: https://www.bailii.org/eu/cases/EUECJ/2025/T1825_CO.html Cite as: [2025] EUECJ T-18/25_CO |
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ORDER OF THE PRESIDENT OF THE GENERAL COURT
4 April 2025 (*)
( Interim relief - Medicinal products for human use - Marketing authorisation for Syfovre - Pegcetacoplan - Application for suspension of operation of a measure - No urgency )
In Case T‑18/25 R,
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,
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
1 By its application under Articles 278 and 279 TFEU, the applicant, Apellis Europe BV, seeks the suspension of the operation of Commission Implementing Decision C(2024) 9160 final of 16 December 2024 refusing marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for the medicinal product for human use 'Syfovre – Pegcetacoplan' ('the contested decision').
Background to the dispute and forms of order sought by the parties
2 The applicant is a pharmaceutical company established in the Netherlands.
3 In December 2022, the applicant submitted an application for marketing authorisation for Syfovre – Pegcetacoplan ('the medicinal product at issue') to the European Medicines Agency (EMA). The proposed therapeutic indication was the treatment of geographic atrophy secondary to age-related macular degeneration.
4 On 27 June 2024, the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a negative scientific opinion on the medicinal product at issue.
5 On 4 October 2024, the applicant informed the European Commission and the EMA that it was withdrawing the application for marketing authorisation for the medicinal product at issue.
6 By letter of 23 October 2024, the applicant requested that the Commission stop the decision-making procedure relating to the application for marketing authorisation for the medicinal product at issue.
7 On 4 November 2024, the Commission informed the applicant that it was refusing to stop the decision-making procedure referred to above.
8 Following several exchanges between the applicant and the Commission, the latter adopted the contested decision on 16 December 2024.
9 By application lodged at the Registry of the General Court on 15 January 2025, the applicant brought an action for the annulment of the contested decision.
10 By a separate document lodged at the Court Registry on the same date, the applicant brought the present application for interim measures, in which it claims that the President of the General Court should:
– order the suspension of the operation of the contested decision until final judgment is reached in the main proceedings;
– reserve the costs pending the outcome of the main proceedings.
11 In its observations on the application for interim measures, which were lodged at the Court Registry on 30 January 2025, the Commission contends that the President of the General Court should:
– dismiss the application for interim measures;
– order the applicant to pay the costs.
Law
General considerations
12 It is apparent from reading Articles 278 and 279 TFEU together with Article 256(1) TFEU that the judge hearing the application for interim measures may, if he or she considers that the circumstances so require, order that the operation of a measure challenged before the General Court be suspended or prescribe any necessary interim measures, pursuant to Article 156 of the Rules of Procedure of the General Court. Nevertheless, Article 278 TFEU establishes the principle that actions do not have suspensory effect, since acts adopted by the institutions of the European Union are presumed to be lawful. It is therefore only exceptionally that the judge hearing an application for interim measures may order the suspension of operation of an act challenged before the General Court or prescribe any interim measures (order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12).
13 The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim measures must state 'the subject matter of the proceedings, the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the interim measure applied for'.
14 The judge hearing an application for interim measures may order suspension of operation of an act and other interim measures, if it is established that such an order is justified, prima facie, in fact and in law, and that it is urgent in so far as, in order to avoid serious and irreparable damage to the applicant's interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, and consequently an application for interim measures must be dismissed if any one of them is not satisfied. The judge hearing an application for interim measures is also to undertake, when necessary, a weighing of the competing interests (see order of 2 March 2016, Evonik Degussa v Commission, C‑162/15 P-R, EU:C:2016:142, paragraph 21 and the case-law cited).
15 In the context of that overall examination, the judge hearing the application for interim measures enjoys a broad discretion and is free to determine, having regard to the particular circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (see order of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 23 and the case-law cited).
16 Having regard to the material in the case file, the President of the General Court considers that he has all the information needed to rule on the present application for interim measures without there being any need first to hear oral argument from the parties.
17 In the circumstances of the present case, it is appropriate to examine first whether the condition relating to urgency is satisfied.
The condition relating to urgency
18 In order to determine whether the interim measures sought are urgent, it should be noted that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future final decision, in order to avoid a lacuna in the legal protection afforded by the EU judicature. To attain that objective, urgency must generally be assessed in the light of the need of an interlocutory order to avoid serious and irreparable damage to the party requesting the interim measure. That party must demonstrate that it cannot await the outcome of the main proceedings without suffering serious and irreparable damage (see order of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P-R, EU:C:2016:21, paragraph 27 and the case-law cited).
19 Furthermore, in accordance with the second sentence of Article 156(4) of the Rules of Procedure, applications for interim relief are to 'contain all the evidence and offers of evidence available to justify the grant of interim measures'.
20 It is in the light of those criteria that it must be examined whether the applicant has succeeded in demonstrating urgency.
21 In the first place, the applicant claims that the contested decision causes a strong stifling effect. According to the applicant, that effect is evidenced by recent exchanges with the medicines authority in Germany, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM, Federal Institute for Medicinal Products and Medical Devices, Germany), with which the applicant entered into discussions with a view to submitting a new application in order to obtain a national marketing authorisation for the medicinal product at issue. The BfArM decided to put an end to those discussions on the basis of the applicable German legislation and its interpretation of the prohibition laid down in Article 12(2) 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).
22 In the second place, the applicant submits that there is no need to demonstrate that it has suffered serious and irreparable damage in order to justify the suspension of the contested decision. According to the applicant, interim measures must be ordered without the need to verify the condition of urgency, on account of the manifest illegality that vitiates the contested decision.
23 In the third place, the applicant claims that suspension of the operation of the contested decision is necessary to prevent the occurrence of serious and irreparable damage consisting of the loss of activity in the European Union, since its entire business activity is focused on the medicinal product at issue in the European Union, of increased dependence on the funding provided by its parent company and of the adoption of restructuring measures, which include considering steps to reduce staff numbers.
24 In the fourth place, the applicant submits that broader public health considerations, such as the interests of patients, must be taken into account in assessing the condition relating to urgency.
25 The Commission disputes the applicant's arguments.
26 In that regard, it must be observed, as a preliminary point, that, by withdrawing its application for marketing authorisation, the applicant has created a factual situation that is identical to the situation resulting from the contested decision. In both cases, the medicinal product in respect of which that authorisation was applied for will not be marketed on the internal market. In the present case, the contested decision cannot affect the applicant's factual situation, which, given that that withdrawal is taken into account, would have been the same if that decision had not been adopted. Therefore, it is not clear what advantage the applicant intends to obtain by seeking suspension of the operation of that decision.
27 It is true that, by its first argument, the applicant submits that Article 12(2) of Regulation No 726/2004 prevents national authorities from granting a marketing authorisation under their national legislation. That argument cannot, however, serve as a basis for the applicant's interest in obtaining suspension of the operation of the contested decision in so far as that article does not preclude the applicant from submitting a new application for marketing authorisation, either at EU level, through the centralised procedure, or at national level for the same medicinal product, provided that such an application is based on additional, updated or new data in relation to the data on the basis of which the CHMP issued a negative opinion and the Commission adopted that decision.
28 In that regard, the applicant submits that the contested decision has a stifling effect on the BfArM, on the basis of an email, contained in Annex A.21 to the application for interim measures, that was sent to the applicant by a member of that institute's staff. Apart from the fact that that email is imprecise and does not necessarily reflect the official position of the BfArM on the effects of the contested decision, it refers to a future event which does not involve the Commission, but an authority of a Member State. The alleged stifling effect relied on by the applicant is not attributable to the contested decision but, as is apparent from the wording of the application for interim measures itself, to the consequences which the BfArM attributes to that decision.
29 Even if the contested decision were to have that stifling effect, it would not, in any event, in accordance with Article 12 of Regulation No 726/2004, constitute a legal obstacle preventing the applicant from applying for marketing authorisation for its medicinal product on the basis of new scientific data based on new studies, new pre-clinical trials and clinical trials that demonstrate its efficacy.
30 In the second place, as regards the applicant's argument that there is no need to demonstrate that it has suffered serious and irreparable damage in order to justify the suspension of the contested decision, on account of the manifest illegality that vitiates that decision, it follows from the case-law of the Court of Justice that the strength of a prima facie case affects the assessment of urgency. The urgency that may be pleaded by an applicant must thus be taken into consideration by the judge hearing the application for interim measures all the more if the prima facie case raised by the pleas and arguments relied on appears particularly serious (see order of the Vice-President of the Court of 12 October 2022, Mariani v Parliament, C‑525/22 P(R), not published, EU:C:2022:797, paragraph 69 and the case-law cited).
31 The fact remains that, in accordance with Article 156(4) of the Rules of Procedure, the conditions relating to a prima facie case and to urgency are distinct and cumulative, so that the party seeking interim measures still needs to prove the imminence of serious and irreparable damage (see order of the Vice-President of the Court of 12 October 2022, Mariani v Parliament, C‑525/22 P(R), not published, EU:C:2022:797, paragraph 70 and the case-law cited).
32 Nevertheless, where a decision appears, in the light of the complaints made against it, to be a measure which lacks even the appearance of legality, the judge hearing the application for interim measures must suspend its operation forthwith, without it being necessary for the party seeking interim measures to show that those measures must be granted to that party in order to avoid the occurrence of serious and irreparable damage (see order of the Vice-President of the Court of 12 October 2022, Mariani v Parliament, C‑525/22 P(R), not published, EU:C:2022:797, paragraph 71 and the case-law cited).
33 It follows from that case-law that only an illegality that is exceptional in terms of its nature and seriousness may warrant an order for suspension of operation of a decision, without the risk of the occurrence of serious and irreparable damage being established, and that it is therefore not sufficient in that regard to show a particularly strong prima facie case (order of the Vice-President of the Court of 12 October 2022, Mariani v Parliament, C‑525/22 P(R), not published, EU:C:2022:797, paragraph 72).
34 According to settled case-law, the possible infringement of a rule of law by a measure is not in principle sufficient to establish, in itself, the seriousness and irreparable nature of any damage caused by that infringement. Consequently, it is not sufficient for the applicant to allege a manifest infringement of rules of law in order to establish that the conditions of urgency, namely the serious and irreparable nature of the damage that might result from that infringement, are satisfied, since the applicant is required to prove the facts forming the basis of its claim that such damage is likely (see, to that effect, order of 30 September 2011, Gollnisch v Parliament, T‑346/11 R, not published, EU:T:2011:553, paragraph 18 and the case-law cited).
35 In the present case, even if it were to be considered, as the applicant submits, that the adoption of the contested decision in spite of the fact that the applicant had withdrawn its application for marketing authorisation for the medicinal product at issue is an obvious illegality, the suspension of the contested decision would not change the factual situation in which the applicant finds itself, since it has itself withdrawn its application for authorisation.
36 Moreover, the manifest illegality relied on, namely that of adopting a decision refusing marketing authorisation after the application for marketing authorisation has been withdrawn, does not appear, in any event, to be so exceptional in terms of its nature and seriousness that the contested decision may be considered to lack even the appearance of legality.
37 The applicant also relies on the allegedly obvious nature of the illegality relied on, without, however, submitting any arguments to show that that illegality is exceptional in terms of its nature and seriousness.
38 Accordingly, even if the adoption of the contested decision, despite the applicant's withdrawal of its application for marketing authorisation for the medicinal product at issue, constitutes an obvious illegality, it must be held that such an illegality is not so exceptional in terms of its nature and seriousness as to demonstrate that the condition relating to urgency is satisfied in the present case.
39 It follows that the applicant's argument cannot succeed.
40 In the third place, first of all, as regards the applicant's argument that its entire business activity is focused on the medicinal product at issue in the European Union, it must be observed, as noted by the Commission, that that argument is at odds with the fact that that medicinal product has never been placed on the market in the European Union. Accordingly, given that it is not possible to place the product on the market without a valid marketing authorisation, subject to certain exceptions, it must be held that the alleged activity cannot be understood as meaning an activity that generates profit or revenue from the sale of the medicinal product at issue.
41 Next, as regards the applicant's argument that it depends entirely on the financing provided by its parent company, it must be borne in mind that, according to settled case-law, purely pecuniary damage cannot in principle be regarded as irreparable or even as reparable only with difficulty, since it may be the subject of subsequent financial compensation (see order of 15 December 2009, Dow AgroSciences and Others v Commission, C‑391/08 P(R), not published, EU:C:2009:785, paragraph 74 and the case-law cited). It can only be otherwise if it appears that, without the interim measures sought, the applicant would be in a position that could imperil its financial viability before final judgment is given in the main action, or that its market share would be substantially affected in the light, inter alia, of the size and turnover of its undertaking and the characteristics of the group to which it belongs. The existence of such circumstances permits the inference that damage of a financial nature is irreparable (order of the Vice-President of the Court of 19 December 2013, Lito Maieftiko Gynaikologiko kai Cheirourgiko Kentro v Commission, C‑506/13 P-R, not published, EU:C:2013:882, paragraph 20).
42 In the present case, the applicant merely claims that its parent company is a rather new pharmaceutical company which is still very much in the clinical development stage and which had an accumulated deficit of 2.8 billion United States dollars (USD) at the end of 2023.
43 In that regard, it should be noted that the applicant alleges the existence of financial losses without, however, specifying the exact nature of those losses or their connection with the contested decision. In particular, it does not explain how the suspension of the operation of that decision would be expected to alter the financial situation that it describes.
44 Last, the applicant maintains that its parent company has begun to restructure its general European business operations, which will include considering steps to reduce staff numbers.
45 In that regard, it is true that, according to the case-law, the fact that an undertaking has to shed jobs and thus lose a trained and operational workforce could cause it direct and personal damage, independently of the separate damage suffered by its employees, to the extent that it will be more difficult subsequently to restart its activities should there be a change in economic conditions (order of 12 June 2014, Commission v Rusal Armenal, C‑21/14 P-R, EU:C:2014:1749, paragraph 52). It is also true that the imminence of the alleged damage does not have to be proved with absolute certainty. The fact remains that it is for the applicant to show, by supporting its assertions with facts and evidence, that the occurrence of that damage may nevertheless be foreseen with a sufficient degree of probability and is not based on future and uncertain events (order of 26 September 2017, António Conde & Companhia v Commission, T‑443/17 R, not published, EU:T:2017:671, paragraph 37).
46 In that regard, it is sufficient to observe that, in the application for interim measures, the applicant merely relies on the potential loss of part of its staff without providing any documents to show that that event would occur if the contested decision were implemented.
47 In the fourth place, as regards the applicant's argument that broader public health considerations must be taken into account in assessing the condition of urgency, such as the interests of patients, it must be stated that, according to settled case-law, the party seeking interim measures may not, in order to establish urgency, rely on damage caused to the rights of third parties or to the general interest (see order of 26 September 2017, António Conde & Companhia v Commission, T‑443/17 R, not published, EU:T:2017:671, paragraph 35 and the case-law cited).
48 According to settled case-law, in order to prove that the condition relating to urgency is satisfied, an applicant is required to show that suspension of the operation of a measure or other interim measures sought are necessary in order to protect its own interests However, in order to establish urgency, an applicant cannot plead damage to an interest which is not personal to it, such as damage to a general interest or to the rights of third parties, be they individuals or a State. Such interests may be taken into consideration only when the General Court comes to weigh up the interests at stake (see order of 10 November 2004, Wam v Commission, T‑316/04 R, EU:T:2004:333, paragraph 28 and the case-law cited).
49 It follows from all of the foregoing that the application for interim measures must be dismissed, since the applicant has failed to establish urgency, without it being necessary to rule on whether there is a prima facie case or to weigh up the interests.
50 Under Article 158(5) of the Rules of Procedure, the costs must be reserved.
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
hereby orders:
1. The application for interim measures is dismissed.
2. The costs are reserved.
Luxembourg, 4 April 2025.
V. Di Bucci | M. van der Woude |
Registrar | President |
* Language of the case: English.
© European Union
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