ORDER OF THE PRESIDENT OF THE GENERAL COURT
29 February 2024 (*)
(Interim relief – Medicinal products for human use – Marketing authorisation for ‘Dimethyl fumarate Neuraxpharm – dimethyl fumarate’ – Application for suspension of operation of a measure – No urgency)
In Case T‑1182/23 R,
Neuraxpharm Pharmaceuticals, SL, established in Barcelona (Spain), represented by K. Roox, T. De Meese, J. Stuyck and C. Dumont, lawyers,
applicant,
v
European Commission, represented by A. Spina and E. Mathieu, acting as Agents,
defendant,
THE PRESIDENT OF THE GENERAL COURT
makes the following
Order
1 By its application based on Articles 278 and 279 TFEU, the applicant, Neuraxpharm Pharmaceuticals, SL, seeks suspension of the operation of Commission Implementing Decision C(2023) 8921 final of 13 December 2023 revoking Commission Implementing Decision C(2022) 3254 final of 13 May 2022 granting marketing authorisation 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, for ‘Dimethyl fumarate Neuraxpharm – dimethyl fumarate’, a medicinal product for human use (‘the contested decision’).
Background to the dispute and forms of order sought by the parties
2 The applicant is a pharmaceutical company which develops and markets medicinal products, including the generic medicinal product ‘Dimethyl fumarate Neuraxpharm – dimethyl fumarate’ (‘DMF Neuraxpharm’), indicated for the treatment of multiple sclerosis.
3 On 28 February 2012, Biogen Idec Ltd filed an application with the European Medicines Agency (EMA), pursuant to Article 4(1) of Regulation No 726/2004, for a marketing authorisation (‘MA’) for the medicinal product ‘Tecfidera – dimethyl fumarate’ (‘Tecfidera’).
4 On 30 January 2014, the European Commission adopted Implementing Decision C(2014) 601 final granting that marketing authorisation under Regulation No 726/2004 (‘the implementing decision of 30 January 2014’). In recital 3 of that implementing decision, the Commission states that Tecfidera, on the one hand, and the already authorised medicinal product known as Fumaderm, on the other, do not belong to the same global marketing authorisation as described in Article 6(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).
5 On 27 November 2017, Pharmaceutical Works Polpharma S.A. submitted a request to the EMA seeking confirmation that it was eligible to file an MA application under the centralised procedure in accordance with Article 3(3) of Regulation No 726/2004 for a generic medicinal product derived from Tecfidera and known as ‘Dimethyl Fumarate Pharmaceutical Works Polpharma’.
6 By a decision of 30 July 2018 (‘the EMA decision of 30 July 2018’), the EMA informed Pharmaceutical Works Polpharma that it was unable to validate its application for the grant of an MA for a generic medicinal product derived from Tecfidera, on the ground that, in essence, according to recital 3 of the implementing decision of 30 January 2014, Tecfidera, on the one hand, and the already authorised medicinal product Fumaderm, on the other, did not belong to the same global marketing authorisation as described in Article 6(1) of Directive 2001/83, and that, consequently, since Tecfidera benefits from an independent eight-year period of data protection, that protection period had not yet expired.
7 By application lodged at the Registry of the General Court on 9 October 2018 and registered as Case T‑611/18, Pharmaceutical Works Polpharma brought an action seeking annulment of the EMA decision of 30 July 2018 and raised a plea of illegality under Article 277 TFEU in respect of the implementing decision of 30 January 2014 in so far as, in that implementing decision, the Commission considered that Tecfidera was not covered by the same global marketing authorisation as Fumaderm.
8 By judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), the General Court upheld the plea of illegality raised by Pharmaceutical Works Polpharma and annulled the EMA decision of 30 July 2018.
9 That judgment was the subject of three appeals brought by the Commission, Biogen Netherlands BV (‘Biogen’) and the EMA.
10 Following the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), the applicant submitted an application for an MA for a generic version of Tecfidera.
11 On 13 May 2022, the Commission granted the applicant an MA for DMF Neuraxpharm by Implementing Decision C(2022) 3254 final granting marketing authorisation under Regulation No 726/2004 for DMF Neuraxpharm as a medicinal product for human use.
12 Biogen brought an action for annulment of that decision. That action is currently pending before the General Court (Case T‑278/22).
13 After obtaining the MA, as from 2022, the applicant began to launch the medicinal product DMF Neuraxpharm in various Member States of the European Union.
14 By 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), the Court of Justice set aside the judgment of the General Court of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241). Ruling subsequently on the action at first instance, the Court of Justice rejected the single plea in law alleging illegality of the implementing decision of 30 January 2014 and, accordingly, dismissed the action.
15 On 2 May 2023, the Commission adopted Implementing Decision C(2023) 3067 final amending the MA granted by the implementing decision of 30 January 2014, granting Biogen an additional year of marketing protection for Tecfidera until 2 February 2025, with retroactive effect from 16 March 2023.
16 On 13 December 2023, the Commission adopted the contested decision, by which it repealed Implementing Decision C(2022) 3254 final granting marketing authorisation for DMF Neuraxpharm.
17 By application lodged at the Registry of the General Court on 23 December 2023, the applicant brought an action, seeking, in essence, annulment of the contested decision.
18 By separate document, lodged at the Court Registry on the same date, the applicant brought the present application for interim relief, in which it claims, in essence, that the President of the General Court should:
– order, even before the other party to the proceedings has submitted its observations, under Article 157(2) of the Rules of Procedure of the General Court, that the operation of the contested decision be suspended until the General Court has examined, and given a ruling on, the present application for interim relief;
– order that the operation of the contested decision be suspended pending delivery of the judgment in the main proceedings;
– order the Commission to pay the costs.
19 In its observations on the application for interim relief, which were lodged at the Court Registry on 23 January 2024, the Commission contends that the President of the General Court should:
– refuse the application for interim relief;
– order the applicant to pay the costs.
Law
General considerations
20 It is apparent from reading Articles 278 and 279 TFEU together with Article 256(1) TFEU that the judge hearing an application for interim relief 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. 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 relief 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).
21 The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim relief 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’.
22 Accordingly, the judge hearing an application for interim relief may order suspension of operation of an act, or 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 harm to the interests of the party seeking those measures, 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 refused if any one of them is not satisfied. Where appropriate, the judge hearing an application for interim relief is also to weigh up the interests involved (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).
23 In the context of that overall examination, the judge hearing the application for interim relief 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).
24 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 relief without there being any need to hear oral argument from the parties beforehand.
25 In the circumstances of the present case, it is appropriate to begin by examining whether the condition relating to urgency is satisfied.
The condition relating to urgency
26 In order to determine whether the interim measures sought are urgent, it should be borne in mind that the purpose of proceedings for interim relief is to guarantee the full effectiveness of the future final decision, in order to prevent 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 protection. 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).
27 In addition, 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’.
28 It is in the light of those criteria that it is necessary to examine whether the applicant has succeeded in demonstrating urgency.
29 In the present case, in order to demonstrate the serious and irreparable nature of the alleged damage, in the first place, the applicant submits that the contested decision will result in the complete loss of its market share and in a loss in profits on sales of DMF Neuraxpharm, and that that damage is impossible to quantify. The applicant also submits that there is uncertainty as to the fate of the DMF Neuraxpharm already placed on the market under its MA and that it may be necessary to destroy stocks of medicinal products with a short shelf life.
30 In the second place, it argues that the contested decision has triggered and will trigger reactions on the part of third parties. First, the applicant’s MAs granted by national authorities could be withdrawn if those authorities were to follow the Commission’s actions. Secondly, Biogen is using the contested decision to its advantage, in particular in various proceedings at national level. Thirdly, the disruption in the supply of DMF Neuraxpharm risks affecting the applicant’s contractual relations in the sphere of public procurement.
31 In the third place, the contested decision risks undermining the reputation of the applicant as well as that of the generic medicines industry as a whole and licence holders operating in connection with its MA, in so far as third parties might think that DMF Neuraxpharm is unavailable on account of public health issues.
32 In the fourth place, the contested decision will have consequences for patients who currently take DMF Neuraxpharm and for the public finances of the Member States, in so far as the price of Tecfidera is much higher than that of generic medicinal products. In addition, the contested decision could give rise to shortages in some Member States.
33 In the fifth place, suspension of the operation of the contested decision is necessary to maintain the full effectiveness of a future judgment annulling that decision, given that, by the time that judgment is delivered, Tecfidera’s marketing protection will have expired.
34 In the sixth place, the condition relating to urgency is satisfied on the ground that the contested decision is manifestly illegal. In addition, the infringement of the applicant’s rights and fundamental freedoms is continuous and cannot be remedied by compensation after the fact.
35 The Commission disputes the applicant’s arguments.
36 In the first place, as regards the applicant’s arguments that the contested decision will undermine patients, Member States, the generic medicines industry, licence holders operating in connection with its MA, and other third parties, those arguments must be rejected in so far as the alleged damage does not relate to the applicant’s own interests.
37 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 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).
38 In the second place, as regards the damage relating to the loss of market share and profits, first, it should be stated that the applicant can rely only on damage that stems from the contested decision. It is therefore necessary to disregard damage that is attributable to other factors, such as the reactions of third parties triggered by the contested decision. Accordingly, in order to determine the damage for the purposes of the present proceedings for interim relief, the fact that national authorities might possibly withdraw the MAs from which the applicant benefits in certain Member States, or that Biogen could rely on the contested decision in actions directed against the applicant, cannot be taken into account. These are, moreover, future and uncertain elements.
39 Secondly, as regards the loss of market share and profits attributable to the contested decision, it should be stated that that damage is of a financial nature, inasmuch as it consists of the loss of income likely to accrue from future sales of DMF Neuraxpharm.
40 In that regard, it should be borne in mind that damage of a pecuniary nature cannot, save in exceptional circumstances, be regarded as irreparable, since, as a general rule, pecuniary compensation is capable of restoring the injured party to the situation that obtained before the damage occurred. Any such damage could be remedied by the bringing of an action for damages on the basis of Articles 268 and 340 TFEU (see order of 23 April 2015, Commission v Vanbreda Risk & Benefits, C‑35/15 P(R), EU:C:2015:275, paragraph 24 and the case-law cited).
41 However, where the alleged damage is of a financial nature, the interim measures sought are justified where, in the absence of those measures, the party seeking those measures would be in a position that would imperil its financial viability before final judgment is given in the main action, or where its market share would be affected substantially in the light of, inter alia, the size and turnover of its undertaking and, as the case may be, the characteristics of the group to which it belongs (see order of 12 June 2014, Commission v Rusal Armenal, C‑21/14 P-R, EU:C:2014:1749, paragraph 46 and the case-law cited).
42 In that context, the applicant has not stated, let alone established, that it is in a position that would imperil its financial viability before final judgment is given in the main action.
43 While the applicant provides the turnover generated by sales of DMF Neuraxpharm in various Member States from its launch in 2022 to February 2023 – approximately EUR 10 300 000 – it does not provide any information as regards the size and turnover of its undertaking and, as the case may be, the characteristics of the group to which it belongs. Thus, it is not possible to assess the significance of the damage allegedly suffered by the applicant by reason of the loss of market share and profits in the light of its overall turnover.
44 In addition, it is apparent from recital 19 of the contested decision that that decision does not prevent the applicant from submitting a new MA application for its generic version of Tecfidera. Accordingly, assuming that the applicant will be allowed to market DMF Neuraxpharm again following the expiry of Tecfidera’s marketing protection, namely on 2 February 2025, it will have been prevented from marketing DMF Neuraxpharm for approximately 14 months, which corresponds to a relatively limited period.
45 Thirdly, the applicant claims that it is impossible to quantify the losses suffered given that (i) when it is able to return to the market with a new MA, there will be more competitors, which means that it will lose its first-mover advantage, and (ii) its market share was increasing at the time the contested decision was adopted and it will therefore be impossible to determine what its market share would have been in the absence of that decision.
46 In that regard, it should be noted that, according to settled case-law, damage of a financial nature may be considered to be serious and irreparable if the damage, even when it occurs, cannot be quantified (see order of 28 November 2013, EMA v InterMune UK and Others, C‑390/13 P(R), EU:C:2013:795, paragraph 49 and the case-law cited).
47 However, the uncertainty of obtaining compensation for damage of a pecuniary nature if an action for damages is brought cannot in itself be regarded as a factor capable of establishing that such damage is irreparable within the meaning of the case-law of the Court. At the interlocutory stage, the possibility of subsequently obtaining compensation for damage of a pecuniary nature if an action for damages is brought following annulment of the contested measure is necessarily uncertain. Proceedings for interim relief are not intended to act as a substitute for an action for damages in order to remove that uncertainty, since their purpose is only to guarantee the full effectiveness of the final future decision that will be made in the main action (in this case an action for annulment), to which those proceedings are an adjunct (see order of 28 November 2013, EMA v InterMune UK and Others, C‑390/13 P(R), EU:C:2013:795, paragraph 50 and the case-law cited).
48 By contrast, the situation is different where it is already clear, when the assessment is carried out by the judge hearing the application for interim relief, that, in view of its nature and the manner in which it will foreseeably occur, the alleged damage, should it occur, may not be adequately identified or quantified and that, in practice, it will not therefore be possible to make good that damage by bringing an action for damages (see order of 28 November 2013, EMA v InterMune UK and Others, C‑390/13 P(R), EU:C:2013:795, paragraph 51 and the case-law cited).
49 In the present case, it must be pointed out that the applicant submits turnover relating to sales in various Member States during the months following the initial market launch of DMF Neuraxpharm. The applicant therefore has comparators enabling it to establish a forecast of the sales development that it is likely to be able to achieve following the future marketing of DMF Neuraxpharm on the basis of a new MA. Therefore, it cannot validly be held that the applicant’s damage is in no way quantifiable and is therefore irreparable.
50 It must also be stated that the applicant has not put forward convincing evidence permitting the conclusion that the conditions of competition will be different when the applicant is once again able to sell DMF Neuraxpharm on the market at issue, in particular as concerns the number of competitors and the growth rate of its sales.
51 Fourthly, as regards the damage relating to the uncertainty concerning the products already placed on the market by the applicant and the possible destruction of stocks of medicinal products, it must be held that the applicant’s line of argument lacks clarity and is not sufficient to substantiate the existence of serious and irreparable damage. As regards in particular the destruction of stocks of medicinal products, such damage is (i) of a financial nature and (ii) quantifiable. It cannot be described as irreparable as it may be remedied by compensation after the fact.
52 Fifthly, as regards the possible consequences for the applicant’s public procurement contracts, it must be found that, at this stage, that damage remains hypothetical and imprecise. The applicant argues in that regard that, in general, such contracts contain penalty clauses in the event of a supply issue. It is not, however, clear whether it is possible for the applicant to plead the contested decision as a case of force majeure to explain a possible disruption of supply. In addition, the applicant specifies neither the significance of the contracts at issue in the light of all of its activity nor the amount of the penalty incurred in the event of non-performance of those contracts. Therefore, the applicant has not established the imminent risk of the occurrence of serious damage.
53 Furthermore, if the applicant were required, in the future, to pay damages to those counterparties, it would suffer damage of a financial nature which cannot be considered to be irreparable since it is precise and quantifiable damage that may be remedied by compensation after the fact.
54 In the third place, as regards the alleged damage to the applicant’s reputation deriving from the fact that third parties might think that DMF Neuraxpharm is unavailable on account of public health issues, the applicant claims that the rules contained in Directive 2001/83 preclude it from informing the market of the true reason for the cessation of supply.
55 In that regard, first of all, it should be stated that suspending the operation of a decision would not make good the damage to that reputation – if such damage is assumed to be established and to have essentially materialised – more than the possible future annulment of the decision at the end of the main action (see order of 17 February 2017, Janssen-Cases v Commission, T‑688/16 R, not published, EU:T:2017:107, paragraph 20 and the case-law cited).
56 Next, if damage to the applicant’s reputation were indeed to be the consequence of the adoption of the contested decision, the applicant could inform doctors, pharmacists, patients and other interested parties of the contested decision and the reasons set out in that decision which make clear that its MA was not revoked on account of public health issues.
57 It must be pointed out that the contested decision is a public decision accessible by any interested party on the Commission’s website and that there is no apparent reason precluding the applicant from disseminating that information. Furthermore, the applicant has not specified how the rules contained in Directive 2001/83 constitute an obstacle in that regard.
58 Accordingly, the applicant has not demonstrated that it would be impossible, by reason of obstacles of a structural or legal nature, to regain its reputation, in particular by appropriate publicity measures (see, to that effect, order of 27 August 2008, Melli Bank v Council, T‑246/08 R, not published, EU:T:2008:301, paragraph 55).
59 Lastly, it should be added that it is apparent from the case-law that, in the case of the suspension of a product’s MA, in the highly regulated sector of the EU pharmaceutical market, such a suspension forms part of the uncertainties of the market that are faced regularly by all market operators. It is common knowledge that many undertakings operating on that type of market have already had their products withdrawn from the market without it being possible to say that those undertakings or their products were stigmatised as a result. The regulatory authorities and businesses in the sector concerned, which are familiar with the regulatory framework, tend, rather, to view that type of decision as a normal part of a regulatory procedure (see, to that effect, order of 15 November 2011, Xeda International v Commission, T‑269/11 R, not published, EU:T:2011:665, paragraph 43 and the case-law cited).
60 It follows that the applicant has not demonstrated the existence of damage connected with damage to its reputation.
61 In the fourth place, the applicant’s line of argument stating that suspension of the operation of the contested decision is necessary to maintain the full effectiveness of a future judgment annulling that decision is entirely irrelevant for the purpose of assessing the condition relating to urgency, in so far as that circumstance is not capable of demonstrating that the applicant would, in the event of its application for interim relief being refused, suffer serious and irreparable damage.
62 In the fifth place, concerning the applicant’s assertion that (i) the condition relating to urgency is satisfied on the ground that the contested decision is manifestly illegal and (ii) the applicant would suffer irreparable damage consisting in the continuous infringement of its rights and fundamental freedoms, the applicant submits, in essence, that the Commission wrongly found, retroactively and by reason of the judgment of the Court of Justice of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), that data protection existed for Tecfidera at the date of filing of its MA application. The applicant also submits that the Commission acted on the basis of the principle that an unlawful administrative act should be withdrawn in order to revoke its MA, whereas only Article 81 of Regulation No 726/2004 may serve as a legal basis permitting the revocation of an MA.
63 In that regard, it must be held that the applicant’s arguments are not capable of establishing the existence of serious and irreparable damage justifying urgency in respect of the interim measures sought.
64 The condition relating to the serious and irreparable nature of the alleged damage is different to that relating to a prima facie case, even if it cannot be excluded that suspension of operation or other interim measures may be ordered on the sole basis of the manifest illegality of the contested measure, for example where that measure lacks even the appearance of legality and its operation must, for that reason, be suspended forthwith (see, to that effect, orders of 7 July 1981, IBM v Commission, 60/81 R and 190/81 R, EU:C:1981:165, paragraphs 7 and 8, and of 26 March 1987, Hoechst v Commission, 46/87 R, EU:C:1987:167, paragraphs 31 and 32).
65 However, although, as is apparent from paragraph 110 of the order of the President of the Court of Justice of 23 February 2001, Austria v Council (C‑445/00 R, EU:C:2001:123), the particularly strong nature of the prima facie case is not without influence on the assessment of urgency, there are, in accordance with Article 156(4) of the Rules of Procedure, two distinct conditions for obtaining suspension of operation or other interim measures. It is therefore for the party seeking the interim measures to demonstrate the imminence of damage which is serious and reparable only with difficulty, if not irreparable, and the mere demonstration of a prima facie case, even a particularly strong one, cannot make up for a complete failure to demonstrate urgency, save in very specific circumstances (see, to that effect, order of 2 May 2007, IPK International – World Tourism Marketing Consultants v Commission, T‑297/05 R, not published, EU:T:2007:118, paragraph 52 and the case-law cited).
66 Furthermore, the illegality claimed does not appear to be exceptional in terms of its nature and seriousness, such that the contested decision lacks even the appearance of legality. That applies, in particular, in the light of the judgment of the Court of Justice of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), in view of which the Commission was required to take measures to comply therewith as provided for in Article 266 TFEU.
67 Since the applicant has not established that the condition relating to urgency has been satisfied, the application for interim relief must be refused, without it being necessary to rule on whether there is a prima facie case or to weigh up the interests involved.
68 Under Article 158(5) of the Rules of Procedure, the costs are to be reserved.
On those grounds,
THE PRESIDENT OF THE GENERAL COURT
hereby orders:
1. The application for interim relief is refused.
2. The costs are reserved.
Luxembourg, 29 February 2024.
V. Di Bucci | | M. van der Woude |