Court of Justice of the European Communities (including Court of First Instance Decisions)

ORDER OF THE PRESIDENT OF THE GENERAL COURT

23 November 2018 (*)

(Interim relief — Medicinal products for human use — Active substance trientine tetrahydrochloride — Commission decision not to classify the medicinal product Cuprior-trientine as an orphan medicinal product — Regulation (EC) No 141/2000 — Application for suspension of operation of a measure — Lack of urgency)

In Case T‑733/17 R,

GMP-Orphan (GMPO), established in Paris (France), represented by M. Demetriou QC, E. Mackenzie, Barrister, L. Tsang and J. Mulryne, Solicitors,

applicant,

v

European Commission, represented by K. Petersen and A. Sipos, acting as Agents,

defendant,

APPLICATION under Articles 278 and 279 TFEU for suspension of operation of Article 5 of Commission Implementing Decision C(2017) 6102 final of 5 September 2017 granting marketing authorisation under 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) for ‘Cuprior-trientine’, a medicinal product for human use,

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order

 Background to the dispute, procedure and forms of order sought

1        The applicant, GMP-Orphan (GMPO), has developed the medicinal product Cuprior, which contains the active substance trientine tetrahydrochloride (TETA 4HCl), used in the treatment of Wilson’s disease, a rare genetic disorder characterised by an excessive accumulation of copper in the body, particularly in the liver and the brain, causing lesions.

2        On the basis of a favourable opinion of the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA), the European Commission, on 19 March 2015, granted the applicant’s application for Cuprior to be designated as an orphan medicinal product. In its opinion, the Committee for Orphan Medicinal Products found that the active substance concerned met the criteria for designation as an orphan medicinal product in accordance with Article 3 of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1).

3        On 7 December 2016, the applicant submitted an application for an orphan marketing authorisation to the EMA for the product Cuprior under the centralised procedure pursuant to 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).

4        On 28 April 2017, the Committee for Medicinal Products for Human Use issued a positive opinion on granting marketing authorisation in respect of Cuprior.

5        In accordance with Article 5(12)(b) of Regulation No 141/2000, the Committee for Orphan Medicinal Products also considered whether the criteria for designation as an orphan medicinal product laid down in Article 3 of that regulation were still met. In its opinion of 23 May 2017, it takes the view that the criteria for designation as set out in Article 3(1)(b) are not met.

6        On 7 June 2017, the applicant requested a re-examination of that opinion, and a hearing was held on 11 July 2017, following which the Committee for Orphan Medicinal Products maintained its negative opinion, which it published on 20 July 2017.

7        On the basis of that opinion, the Commission adopted Implementing Decision C(2017) 6102 final of 5 September 2017 (‘the contested decision’), by which it grants marketing authorisation for Cuprior and requires its removal from the Register of Orphan Medicinal Products.

8        By application lodged at the General Court Registry on 2 November 2017, the applicant asked the Court, in particular, to annul Article 5 of the contested decision, which finds that Cuprior should not be classified as an orphan medicinal product, and to order the Commission to designate Cuprior as an orphan medicinal product and to update the Register of Orphan Medicinal Products accordingly.

9        By separate document, lodged at the Court Registry on the same day, the applicant made an application for interim measures, in which it claims, in essence, that the President of the General Court should:

–        suspend the implementation of Article 5 of the contested decision and restore the status quo ante whereby Cuprior benefited from designation as an orphan medicinal product;

–        order the Commission to pay the costs.

10      In its observations on the application for interim measures, lodged at the Court Registry on 23 November 2017, the Commission contends that the President of the General Court should:

–        dismiss the application for interim measures;

–        order the applicant to pay the costs.

11      By letter of 1 December 2017, the applicant requested permission to lodge observations on those submitted by the Commission on 23 November 2017. The President of the General Court having granted that request, the applicant lodged its observations on 12 December 2017, on which the Commission, in turn, lodged observations on 20 December 2017.

12      By letter of 22 March 2018, the applicant sent the Court information concerning developments regarding an application to the EMA in respect of a trientine-based medicinal product. On 28 March 2018, the Commission lodged its observations on that document.

 Law

 General considerations

13      It is apparent from Articles 278 and 279 TFEU, read in conjunction with Article 256(1) TFEU, that the judge hearing an application for interim measures may, if he considers that circumstances so require, order that operation of an act contested 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 a judge hearing an application for interim measures may order suspension of operation of an act contested before the General Court or prescribe interim measures (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 17 and the case-law cited).

14      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’.

15      Accordingly, the judge hearing an application for interim measures 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 applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, so that an application for interim measures must be dismissed if either of them is absent. Where appropriate, the judge hearing such an application must also 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).

16      In the context of that overall examination, the judge hearing the application has a wide discretion and is free to determine, having regard to the specific 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).

17      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.

18      In the circumstances of the present case, and without it being necessary to rule on the pleas of inadmissibility put forward by the Commission, it is appropriate to examine first whether the condition relating to urgency is satisfied.

 Urgency

19      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 prevent a lacuna in the legal protection afforded by the Courts of the European Union. To attain that objective, urgency must, in general terms, 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).

20      In addition, according to well-established case-law, there is urgency only if the serious and irreparable damage feared by the party seeking the interim measures is so imminent that its occurrence can be foreseen with a sufficient degree of probability. That party remains, in any event, required to prove the facts that form the basis of its claim that such damage is likely, it being clear that purely hypothetical damage, based on future and uncertain events, cannot justify the granting of interim measures (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 24 and the case-law cited).

21      Moreover, according to the second sentence of Article 156(4) of the Rules of Procedure, an application for interim measures ‘shall contain all the evidence and offers of evidence available to justify the grant of interim measures’.

22      Thus, an application for interim measures must, of itself, enable the defendant to prepare its observations and the judge hearing the application to rule on it, if necessary, without any supporting information, since the essential elements of fact and law on which the application is based must be found in the actual text of that application (see order of 6 September 2016, Inclusion Alliance for Europe v Commission, C‑378/16 P-R, not published, EU:C:2016:668, paragraph 17 and the case-law cited).

23      It is also settled case-law that, in order to determine whether all the conditions referred to in paragraphs 19, 20 and 22 above are fulfilled, the judge hearing the application for interim measures must have concrete and precise indications, supported by detailed, certified documentary proof, which shows the situation in which the party seeking the interim measures finds itself and enables the probable consequences, should the measures sought not be granted, to be assessed. It follows that that party, in particular when it relies on the occurrence of financial damage, must produce, with supporting documentation, a true overall picture of its financial situation (see orders of 20 April 2012, Fapricela v Commission, C‑507/11 P(R), EU:C:2012:231, paragraphs 52 to 54 and the case-law cited, and of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 27 and the case-law cited).

24      While the application for interim measures may be supplemented on specific points by references to documents annexed to it, those documents cannot compensate for the lack of essential information in that application. It is not for the judge hearing the application for interim measures to seek, in the stead of the party concerned, those matters contained in the annexes to the application for interim measures, in the application lodged in the main proceedings or in the annexes thereto which could support the application for interim measures. For such an obligation to be imposed on the judge hearing the application for those measures would, moreover, render ineffective Article 156(5) of the Rules of Procedure, which requires the application for interim measures to be made by a separate document (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 28 and the case-law cited).

25      It is necessary to examine in the light of those criteria whether the applicant has been able to demonstrate the existence of serious and irreparable harm.

 The serious nature of the harm

26      In the first place, the applicant claims that, if its application is not granted, it risks sustaining serious harm in so far as the loss of the designation as an orphan medicinal product threatens its viability and that that would probably result in its insolvency in March 2018.

27      First, it must be noted that the nature of the alleged harm concerning the applicant’s viability is purely financial. As regards the seriousness of such harm, it is well-established case-law that the interim measure sought will be justified only if it appears that, without such a measure, the applicant would be in a position that could imperil its existence before final judgment is given in the main action (see order of 30 April 2010, Xeda International v Commission, T‑71/10 R, not published, EU:T:2010:173, paragraph 42 and the case-law cited). In that regard, the assessment of the serious nature of such harm must be carried out in the light, inter alia, of the size and turnover of the undertaking and the characteristics of the group to which it belongs (see order of 15 November 2011, Xeda International v Commission, T‑269/11 R, not published, EU:T:2011:665, paragraph 20 and the case-law cited; see also, to that effect, order of 15 April 1998, Camar v Commission and Council, C‑43/98 P(R), EU:C:1998:166, paragraph 36 and the case-law cited).

28      In the present case, it must, however, be noted that, contrary to the case-law mentioned in paragraphs 22 to 24 above, the applicant’s shareholding structure is not clear from its written submissions, despite the permission granted to the applicant by the President of the General Court to supplement its application, inter alia, in that respect.

29      The applicant states that it is a ‘start-up’ funded by two independent major institutional venture capital funds and a minority investment by existing employees. It adds that it is independent from all its investors and subject to its own corporate governance overseen by the board of management, that its investors’ overall financial resources are not relevant to its financial situation and that those investors have no legal obligation to continue to fund it. However, it is apparent from a letter from its lawyers, annexed to its observations, that its two principal shareholders are, in essence, Advent Life Sciences LLP (50.70%), a member of whom sits on the applicant’s board of directors, and BPifrance Investissement (21.82%), no information as to the financial situation of which was provided, contrary to the requirements laid down by well-established case-law.

30      In assessing the financial viability of an undertaking, consideration may be given, for the purposes of assessing its economic circumstances, to the characteristics of the group of which, by virtue of its shareholding structure, directly or indirectly, it forms part (see orders of 7 March 1995, Transacciones Marítimas and Others v Commission, C‑12/95 P(R), EU:C:1995:62, paragraph 12 and the case-law cited, and of 13 April 2011, Westfälische Drahtindustrie and Others v Commission, T‑393/10 R, EU:T:2011:178, paragraph 37 and the case-law cited).

31      That approach is justified in the case-law by the consideration that the objective interests of the undertaking concerned are not to be viewed independently from the interests of the natural or legal persons who control it, so that the serious and irreparable nature of the purported damage must be assessed also by reference to the financial situation of the persons controlling that undertaking (see orders of 20 April 2012, Fapricela v Commission, C‑507/11 P(R), EU:C:2012:231, paragraph 33 and the case-law cited, and of 13 April 2011, Socitrel v Commission, T‑413/10 R, not published, EU:T:2011:179, paragraph 37 and the case-law cited).

32      In particular, given that the interests at stake overlap, the undertaking’s interest in its own survival must not be viewed in isolation from the interest of those controlling it in prolonging its life indefinitely (see orders of 14 December 2011, Alcoa Trasformazioni v Commission, C‑446/10 P(R), not published, EU:C:2011:829, paragraph 18 and the case-law cited; of 20 April 2012, Fapricela v Commission, C‑507/11 P(R), EU:C:2012:231, paragraph 34 and the case-law cited; and of 10 June 2011, Companhia Previdente v Commission, T‑414/10 R, not published, EU:T:2011:268, paragraph 37 and the case-law cited). Thus, underpinning that case-law is not the existence of a legal obligation on the part of the shareholders to provide the funding necessary to avoid an applicant’s insolvency, but the existence of a concurrence of interests.

33      For the same reasons, in order to assess, in a comparable situation, the damage to an association of undertakings, the financial situation of its members must be taken into account where the objective interests of the association are not autonomous in relation to those of the undertakings belonging to it (see orders of 30 April 2010, Ziegler v Commission, C‑113/09 P(R), not published, EU:C:2010:242, paragraph 47 and the case-law cited, and of 21 January 2004, FNSEA and Others v Commission, T‑245/03 R, EU:T:2004:16, paragraph 84 and the case-law cited).

34      Those reasons — in the light of which it is proper to take into account the group when determining the level of the damage suffered by the company seeking interim relief and whether that damage is irreparable — also mean that it is proper to examine whether, at least, the applicant’s majority shareholder is not prevented from providing it with assistance. Given that the interest in the survival of the undertaking concerned must be measured in the context of the persons controlling that undertaking, it seems altogether normal that the objective financial situation of the group should serve as the point of reference in assessing whether a risk of serious and irreparable damage is imminent. A simple unilateral refusal of assistance by the principal shareholder of the undertaking concerned cannot be enough to preclude the financial situation of the group as a whole from being taken into account. The extent of the damage alleged cannot flow from the unilateral intent of the majority shareholder of the undertaking seeking suspension (see, to that effect, orders of 23 March 2001, FEG v Commission, C‑7/01 P(R), EU:C:2001:183, paragraph 46; of 7 May 2010, Almamet v Commission, T‑410/09 R, not published, EU:T:2010:179, paragraphs 47, 48 and 57 and the case-law cited; and of 10 June 2011, Eurallumina v Commission, T‑207/07 R, not published, EU:T:2011:265, paragraphs 43 to 45 and the case-law cited).

35      That case-law on groups of companies has since been applied to various situations, notably to single-member companies (see, to that effect, order of 11 October 2007, MB Immobilien v Commission, T‑120/07 R, not published, EU:T:2007:305, paragraph 40); to companies belonging to two natural persons (see, to that effect, order of 13 July 2006, Romana Tabacchi v Commission, T‑11/06 R, EU:T:2006:217, paragraph 102); and to minority shareholdings (50%, 40% and even 30%), since, depending on the capital structure of the company concerned, such (substantial) holdings can be relevant to the assessment of its financial viability, so that an application for interim measures must in any case contain sufficient information about such minority holdings (see, to that effect, orders of 7 May 2010, Almamet v Commission, T‑410/09 R, not published, EU:T:2010:179, paragraphs 57 and 58, and of 24 January 2011, Rubinetterie Teorema v Commission, T‑370/10 R, not published, EU:T:2011:17, paragraphs 39 to 42). That case-law provides only for a duty to provide information with regard to the possibility of a concurrence of interests (order of 13 April 2011, Westfälische Drahtindustrie and Others v Commission, T‑393/10 R, EU:T:2011:178, paragraph 38).

36      It follows from the foregoing that it is for the party seeking interim protection from the judge hearing applications for interim measures to provide the essential evidence that would enable him to establish a true overall picture of that party’s financial situation and of the financial situation of its controlling shareholders. That information must, on the one hand, be specific and precise and, on the other, supported by detailed certified documentary proof (see, to that effect, order of 20 April 2012, Fapricela v Commission, C‑507/11 P(R), EU:C:2012:231, paragraph 35 and the case-law cited).

37      As to whether there is a divergence of interests, the applicant emphasises that the failure to obtain the status of orphan medicinal product would render the additional estimated EUR 5 million investment necessary to launch Cuprior on the EU market commercially non-viable.

38      However, it is apparent from the file that, first, investors have already paid substantial sums (EUR 7 million in the case of Advent Life Sciences) that would probably be entirely lost if Cuprior is not brought to the market; second, the applicant has obtained a designation as an orphan medicinal product from the United States Food and Drug Administration (USFDA) and Advent Life Sciences has committed itself to continuing to invest in that regard; and, third, projections revealing a negative return on investment are based on the lack of protection against the possibility of a competitor product entering the market, although the effects of that situation must not be overstated (see paragraph 70 below).

39      Having regard to the foregoing, it appears that the investors, the applicant’s principal shareholders, do on the face of it have an interest in maintaining the applicant’s viability and that any decision to discontinue investment with regard to EU market placement would be akin to a simple refusal expressing the unilateral intent of the principal shareholders, and not the absence of any concurrence of interests, within the meaning of the case-law cited in paragraphs 31 to 34 above.

40      It follows that, contrary to the applicant’s claims that its shareholders’ resources are irrelevant if they are neither obliged nor wish to invest further in its product, that information is part of the essential evidence enabling the President of the General Court to make his assessment and without which he does not have the true overall picture of the financial situation necessary to carry out his review as to whether the alleged risk in relation to its viability is genuine.

41      Second, it must be noted that, at the time of the signing of this order, the applicant has not brought before the President of the General Court any information concerning the initiation of insolvency proceedings, still less a declaration of insolvency, even though the applicant sent the President of the General Court a letter on 22 March 2018 drawing his attention to further developments supporting the application in other respects.

42      In the second place, the applicant takes the view, in essence, that it is likely to sustain serious harm as a result of being unable to place its product on the market, since the loss of the designation as an orphan medicinal product and, therefore, the lack of market exclusivity, the benefit of which was essential to the decision to invest in the development of that medicinal product, threatens the profitability of its product.

43      As a preliminary point, it must be noted that although, as a result of the adoption of the contested decision, the applicant’s situation may appear less beneficial than it could have been if Cuprior had been designated as an orphan medicinal product, that finding is not sufficient as such to establish that there is a risk of serious harm, within the meaning of the case-law cited in paragraph 27 above.

44      It must also be stated that the harm in relation to the profitability of its product claimed by the applicant appears to be pecuniary in nature. In that regard, and in the light of the case-law referred to in paragraph 27 above, it is evident from the assessment of the President of the General Court in paragraphs 26 to 41 above that the applicant is not in a position that could imperil its existence before final judgment is given in the main action.

45      However, it is apparent from the case-law that it cannot be excluded that financial harm which is objectively significant and which allegedly results from the obligation to make a final commercial choice of some magnitude within a disadvantageous timescale could be considered ‘serious’, or even that the seriousness of such harm could be considered obvious, even in the absence of information concerning the size of the undertaking concerned (see, to that effect, order of 7 March 2013, EDF v Commission, C‑551/12 P(R), EU:C:2013:157, paragraph 33).

46      That case-law must nevertheless be assessed having regard to the field in which the applicant operates (see, to that effect, order of 22 June 2018, FMC v Commission, T‑719/17 R, EU:T:2018:408, paragraph 60). It must be borne in mind that, according to settled case-law, it has been held, on the one hand, that, in the case of a loss accounting for less than 10% of the turnover of undertakings operating in highly regulated markets such as that in the present case, the financial difficulties which they could experience did not appear to be such as to threaten their very existence (see, to that effect, orders of 11 April 2001, Commission v Bruno Farmaceutici and Others, C‑474/00 P(R), EU:C:2001:219, paragraph 106, and of 15 November 2011, Xeda International v Commission, T‑269/11 R, not published, EU:T:2011:665, paragraph 21). On the other hand, in the case of a loss representing almost two thirds of the turnover of those undertakings, whilst accepting that the financial difficulties caused could be such as to threaten their very existence, it has nevertheless been pointed out that, in a highly regulated sector often requiring significant investment, it was for those undertakings to protect themselves against its consequences by adopting an appropriate policy (see, to that effect, order of 16 June 2016, ICA Laboratories and Others v Commission, C‑170/16 P(R), not published, EU:C:2016:462, paragraph 29 and the case-law cited).

47      Consequently, since the applicant’s written submissions seem to indicate that it considers itself to be in a position comparable to that of being under an obligation to make a final commercial choice of some magnitude within a disadvantageous timescale, the applicant’s arguments should be examined in the light of the considerations set out in paragraph 46 above in order to determine whether or not there is serious harm, within the meaning of the case-law cited in paragraph 45 above, notwithstanding the lack of essential evidence of its financial situation (see paragraph 40 above).

48      First, according to the applicant, profits on sales risk being seriously damaged due, first of all, to the costs of launch and time to launch being greater for a non-orphan product.

49      In that regard, it should be recalled that it is settled case-law (see order of 11 November 2013, CSF v Commission, T‑337/13 R, not published, EU:T:2013:599, point 32) that, when suspension of operation of an EU act is sought, the grant of the interim measure requested is justified only where the act at issue constitutes the decisive cause of the alleged serious and irreparable harm (see order of 7 March 2013, EDF v Commission, C‑551/12 P(R), EU:C:2013:157, paragraph 41 and the case-law cited). In that context, it has been held that that harm must result solely from the effects produced by the act at issue and not from a lack of diligence on the part of the party which has sought the interim measures (order of 15 July 2008, CLL Centres de langues v Commission, T‑202/08 R, not published, EU:T:2008:293, paragraph 73; see also, to that effect, orders of 28 May 1975, Könecke v Commission, 44/75 R, EU:C:1975:72, paragraph 3, and of 22 April 1994, Commission v Belgium, C‑87/94 R, EU:C:1994:166, paragraphs 38 and 42). According to the same case-law, if it has not demonstrated the full level of diligence that ought to be demonstrated by a prudent and well-informed undertaking, the party seeking interim measures must bear even harm which it claims is liable to jeopardise its existence or to alter irrevocably its position on the market (see, to that effect, orders of 1 February 2001, Free Trade Foods v Commission, T‑350/00 R, EU:T:2001:37, paragraphs 50, 51 and 59, and of 15 July 2008, CLL Centres de langues v Commission, T‑202/08 R, not published, EU:T:2008:293, paragraph 74).

50      It is apparent from the provisions of Regulation No 141/2000, and specifically from Article 5(1) and Article 7(3) thereof, that the procedure for the designation of a product as an orphan medicinal product has two separate stages, the first covering the period of the development of the medicinal product before the application for marketing authorisation is made, the second arising when that application is made. Thus, as is very clear from Article 5(12)(b) of Regulation No 141/2000, there is no guarantee that a product which was initially designated as an orphan medicinal product during the development stage will retain its classification where the designation criteria are re-examined when the market authorisation is granted. The absence of an acquired right in relation to that designation must, therefore, lead an undertaking to adopt the necessary measures should its product not be granted that designation during the second stage. Such diligence seems to be particularly appropriate where classification as an orphan medicinal product was obtained because of economic considerations, based, for example, on the product’s greater availability or better access, and not because of its intrinsic features, such as, for example, the fact that it has better curative properties, the former being subject more to rapid variations in context linked, for example, to changes in the regulatory framework with regard to distribution requirements, while the latter are predicated on scientific developments involving time and investment.

51      In the present case, the applicant was granted the designation as an orphan medicinal product for its product Cuprior at the development stage (see paragraph 2 above) principally because of the better availability of that product in the European Union. In the light of the case-law referred to in paragraph 49 above and the considerations set out in paragraph 50 above, it must be concluded that the applicant should have anticipated the risk that it would not obtain that designation on applying for marketing authorisation. Consequently, it cannot, for the purpose of demonstrating the seriousness of the harm, put forward an argument based on the possible adverse effects on its profits on sales of its product because of the costs of launch and time to launch being greater for a non-orphan product.

52      Furthermore, the applicant seems to rule out any responsibility on its part for the alleged harm arising as a result of its lack of diligence, on account of its right to assume that a decision on the retention of an orphan designation would be taken lawfully. In that regard, it should be pointed out that the conclusion reached by the President of the General Court in paragraph 51 above does not depend on the lawfulness of the contested decision. Contrary to what is claimed by the applicant, it is not required to prepare financially for the possibility that the Commission would act allegedly unlawfully in deciding its marketing application, but it is required to take into consideration the economic consequences that may arise from a decision not to grant the designation as an orphan medicinal product when the application for marketing authorisation is made.

53      Next, the applicant submits that profits on sales risk being adversely affected as a result of Cuprior not being approved by national public health bodies responsible for adopting new medicines for use in the national healthcare systems. In that regard, it is sufficient to note that the applicant did not develop its argument to the requisite legal standard so as to enable the President of the General Court to examine the possible seriousness of the harm linked to the risk of non-approval by national bodies. It did not explain, in particular, the difference in the regime in that context with a product that has been designated as an orphan medicinal product. In any event, in the light of the material in the file, the alleged risk in relation to decisions by national bodies not to grant approval must be described as hypothetical at this stage. Therefore, applying the case-law referred to in paragraphs 20 and 22 above, that argument must be rejected.

54      Last, the applicant claims that profits on sales are likely to be affected by its inability, in the absence of market exclusivity, to apply preferential pricing.

55      However, first, it must be noted, as did the Commission, that the ability to sell that product at a premium price depends on the agreement of the public health authorities. Since pricing is subject to the outcome of negotiations between the applicant and the public authorities, any harm consisting in the inability to apply preferential pricing is necessarily hypothetical, in that it is based on future and uncertain events. In accordance with the case-law recalled in paragraph 20 above, such harm cannot justify the granting of the interim measures sought.

56      Second, the very purpose of market exclusivity is to enable the holder of the marketing authorisation to obtain a return on his investment that is sufficient to encourage orphan medicinal products to be placed on the market that offer significant clinical benefits, while not guaranteeing any particular level of profit. Consequently, the applicant’s decision to take into account the possible benefit it would have tried to derive from obtaining the market exclusivity attached to the designation of its product as an orphan medicinal product forms part of its commercial strategy and, in the light of the case-law referred to in paragraphs 46 and 49 above, cannot lead to the recognition of serious harm.

57      Second, the applicant claims that non-exclusivity will deprive it of protection against competitor products and, therefore, its ability to recoup the substantial investment made will be seriously undermined.

58      First of all, it must be borne in mind that the existence of a concurrence of interests in keeping the applicant in business has been identified in paragraphs 38 and 39 above, with the result that, at this stage and in the light of the information in the file, it is not clear, contrary to the applicant’s claims, that market placement can be ruled out, which means that it is therefore possible to envisage that the investment made will start to be recouped, pending a ruling on the action in the context of the main proceedings. Although the applicant emphasises certain difficulties affecting the commercial viability of Cuprior’s launch, it is silent on aspects which, a priori and without further information in that respect, seem relevant in the context of an assessment of the merits of its position. Those aspects include the advantage it would derive from having first-mover status and the importance of that status on the market for pharmaceutical products, especially in relation to price setting, acquisition of market share and protection against ‘me-too’ products (see, to that effect, judgment of 6 December 2012, AstraZeneca v Commission, C‑457/10 P, EU:C:2012:770, paragraph 180). Second, the applicant submits that, compared to the reference product, namely the product of Univar BV, holder since 8 August 1985 of a marketing authorisation for the active substance trientine dihydrochloride (TETA 2HCl) that is limited to the territory of the United Kingdom, Cuprior is stable at room temperature and does not therefore need to be refrigerated. On the face of it, that feature seems to represent a competitive advantage, notably in terms of transport and storage, making it possible to envisage some protection against competitor products.

59      Next, the fear expressed by the applicant in relation to the absence of the legal protection attributable to market exclusivity is based on the possibility of competitor products entering the EU market, either because of Univar on the basis of the product it has available or because of manufacturers of generic products.

60      In that regard, it is accepted that the contested decision issued a centralised marketing authorisation in respect of Cuprior when no other product currently has such authorisation.

61      As regards the fear expressed in relation to Univar’s product, it is apparent from examination of the file that that company has submitted an application to the EMA for an EU marketing authorisation in respect of trientine dihydrochloride for the treatment of Wilson’s disease, an application which the EMA validated on 1 March 2018. According to the Commission, in accordance with standard timelines, the EMA’s Committee for Medicinal Products for Human Use is expected to deliver its opinion in early 2019, then the Committee for Orphan Medicinal Products will have to deliver its opinion on designation as an orphan medicinal product, and, once the EMA has finished its work, the file will be forwarded to the Commission for adoption of a Commission implementing decision within 67 days. Additional periods may be added to that timetable if decisions taken at the examination stage are challenged and result in the initiation of a review.

62      In that regard, it should be noted, first, that, having regard to the average duration of proceedings before the General Court, the decision on the substance in the present case will probably be delivered within two years (see, to that effect, order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 90 and the case-law cited). Therefore, the applicant should obtain an answer as to the lawfulness of the contested decision in the latter half of 2019, or shortly after any decision the Commission may take on Univar’s application, if Univar does not take steps to challenge it. In that context, it must be noted that, despite its fears of seeing competitor products placed on the market before the Court has been able to rule on the lawfulness of the contested decision, the applicant did not request that the expedited procedure be applied as provided for in Article 151 et seq. of the Rules of Procedure. Nevertheless, in order to avoid implementation of a decision taken in the context of the procedure relating to Univar’s application before the resolution of the main case, it is not inconceivable that the General Court would decide of its own motion to rule on that case in accordance with the expedited procedure, pursuant to Article 151(2) of the Rules of Procedure. Failing that, it is always possible, if the circumstances so require, to decide that that case be given priority, in accordance with Article 67(2) of those rules.

63      Second, it must be noted that, should Univar actually already have obtained marketing authorisation before the decision is given in the main case, the possibility that the placement of that company’s product on the market might take some time to come into effect cannot be entirely disregarded.

64      Third and last, it must be pointed out that, as the Commission acknowledges, if the Court granted the form of order sought by the applicant and thus annulled the contested decision in the main case, the Commission would be obliged to take a new decision on Cuprior that would have retroactive effect in order to ensure that it covers the period during which the case was pending before the Court.

65      It must, moreover, be noted, as the applicant acknowledges, that even if it had obtained market exclusivity when the marketing authorisation was issued, it would not be protected against acceptance of an application lodged with the EMA and its subsequent examination by the EMA’s Committee for Medicinal Products for Human Use if the applicant were to demonstrate that its product was safer, more effective or clinically superior to Cuprior (the only requirement would have been to state whether the product to which the application relates was a similar product and, if so, a report on the similarity would have had to be supplied). At this stage, however, there is nothing in the file to enable that possibility to be ruled out and, moreover, even if there were, the Commission submits that both the EMA and the Commission itself apply coherent policies and non-discriminatory treatment to applicants for marketing authorisations. Accordingly, despite not having obtained the designation of orphan medicinal product and the market exclusivity that flows from that, the applicant seems to be protected, for the same reasons as those mentioned in respect of Cuprior, against the possibility of Univar’s product benefiting from an orphan marketing authorisation and market exclusivity.

66      In the light of the foregoing, it appears that the fear expressed by the applicant as regards market entry of Univar’s competitor product is unwarranted or, at the very least, premature.

67      In that context, it must be added that the risk of the market entry of Cuprior’s competitor product — manufactured by Univar, which has had marketing authorisation for the United Kingdom since 8 August 1985 (see paragraph 58 above) — existed throughout the development stage of the applicant’s medicinal product. Consequently, the failure to take account of that possibility and of its consequences in terms of investment cannot, in the context of the examination of the seriousness of the harm alleged, support the applicant’s application, in accordance with the case-law referred to in paragraphs 46 and 49 above.

68      As regards the fear expressed by the applicant with regard to the possible market entry of competitor products introduced by manufacturers of generic products, who would be able to rely, according to the applicant, on Cuprior as a reference product and submit an application in any Member State or in accordance with the centralised procedure to the EMA, suffice it to note that that process is regulated and takes a certain amount of time. In the light of the considerations set out in paragraphs 62 to 64 above which apply mutatis mutandis, and without any other information from the applicant in that regard, it seems that the judgment in the main case will be delivered before the harm alleged by the applicant can arise or, at least, be described as serious within the meaning of the case-law cited in paragraph 45 above.

69      Therefore, the failure to obtain market exclusivity has not, in the present case, triggered a major change in the competitive environment. First, a competitor product could have emerged at any point during the development stage and, a fortiori, Univar could at any time have used the mutual recognition procedure in order to have its product authorised in the other Member States of the European Union, and, second, any new market entry of competitor products will, as a result of the legislation in force, take a certain amount of time during which the applicant’s product will be the only product to have a centralised marketing authorisation which should cover a sufficient period so as not to cause serious harm, within the meaning of the relevant case-law.

70      In that regard, it must be noted that the claim that it is not possible to contemplate launching Cuprior on the EU market without the orphan designation in so far as the analyses submitted by the applicant are said to show a negative return on investment is based on the risk of a competitor entering the market. However, as indicated in paragraph 69 above, the failure to obtain that designation does not mean that there has been a major change in that regard. Therefore, in the light of all these points, the account taken by investors of the competitive environment ought to have been similar before and after the adoption of the contested decision. This assessment, showing that the possible competition feared by the applicant cannot emerge immediately after the adoption of the contested decision, thus reinforces the conclusion as to the existence of a concurrence of interests between the applicant and its shareholders (see paragraph 39 above).

71      Last, just as it has been pointed out that the taking into account of any possibility of applying preferential pricing was part of a commercial strategy decision and could not be used to support the present application for interim measures (see paragraph 56 above), the taking into account of any enjoyment of market exclusivity attached to designation as an orphan medicinal product in calculating the return on the investment made in relation to the applicant’s product is also part of its commercial strategy and cannot, in the light of the case-law cited in paragraphs 46 and 49 above, be put forward to support the applicant’s case. As recalled in paragraph 50 above, the risk of not obtaining that exclusivity is expressly provided for in the relevant legislation. The same is true, for example, if an undertaking obtains that exclusivity for 10 years under Article 8(1) of Regulation No 141/2000, but does not guard against the risks potentially arising from the reduction of that period to 6 years, in accordance with Article 8(2) of that regulation.

72      It follows from the foregoing that the financial harm claimed by the applicant cannot be characterised as objectively significant and its seriousness cannot be considered obvious, within the meaning of the case-law cited in paragraph 45 above.

73      In the third place, the applicant invokes the risk of sustaining serious harm because of the loss of profits resulting from the inability to launch its product.

74      In that regard, it is sufficient to note that that argument is based on the fact that, according to the applicant, it will not be able to benefit from 10 years’ market exclusivity. However, as is apparent from paragraphs 59 to 69 above, having regard to the average duration of proceedings before the General Court, the decision in the main case will be delivered some considerable time before the end of that period of 10 years from the adoption of the contested decision, enabling the applicant to bring its product to the market, and, moreover, the effects of the lack of legal protection, arising from the refusal to designate the applicant’s product as an orphan medicinal product, must not be overstated. Consequently, not only must the possible loss of profits be scaled down, but it must also be concluded that, as the case currently stands, the evidence submitted to the President of the General Court is not such as to demonstrate the existence of serious harm in that respect.

75      In the fourth and last place, the applicant mentions harm to its reputation and credibility. However, it is sufficient to note in that regard that the present application for interim measures does not provide details of any such harm and does not, therefore, satisfy the criteria imposed by the case-law as stated in paragraphs 22 to 24 above.

76      In any event, it should be pointed out that the legal framework applicable to applications for designation as an orphan medicinal product that are made during the development stage of a medicinal product does not give the developer of the medicinal product a right to bring the result obtained at the end of that stage to the market as an orphan medicinal product (see paragraph 50 above). It follows from this that the risk of not obtaining that designation is inherent in the application of the relevant legislation and, therefore, is a normal legal consequence. The legislation in question incorporates, by its very nature, the possibility that the competent authorities may not grant the qualifier of orphan medicinal product. Consequently, a refusal to grant that designation cannot have a direct causal link with alleged damage to the reputation of the applicant for marketing authorisation as an orphan medicinal product (see, to that effect, in the field of public procurement, order of 4 September 2012, Elitaliana v Eulex Kosovo, T‑213/12 R, not published, EU:T:2012:398, paragraph 14 and the case-law cited, and, in relation to the withdrawal of marketing authorisation for a medicinal product, order of 11 July 2018, GE Healthcare v Commission, T‑783/17 R, EU:T:2018:503, paragraph 62).

77      In the light of the foregoing, it must be concluded that the applicant has not demonstrated the seriousness of the alleged harm.

 The irreparable nature of the harm

78      Nor, moreover, does it appear that the harm alleged in the present case can be characterised as irreparable.

79      In the first place, it is settled case-law that damage of a pecuniary nature cannot, save in exceptional circumstances, be regarded as irreparable or even reparable only with difficulty, since, as a general rule, pecuniary compensation is capable of restoring the aggrieved person to the situation that obtained before he suffered the damage. Any such damage could, in particular, be recouped by the applicant’s bringing an action for compensation on the basis of Articles 268 and 340 TFEU (see orders of 28 November 2013, EMA v InterMune UK and Others, C‑390/13 P(R), EU:C:2013:795, paragraph 48 and the case-law cited, and of 28 April 2009, United Phosphorus v Commission, T‑95/09 R, not published, EU:C:2009:124, paragraph 33 and the case-law cited).

80      In the event of such damage, the interim measure sought is justified only if it appears that, without that measure, the applicant would be in a position that could imperil its existence before the final decision in the main action (see order of 22 June 2018, Arysta LifeScience Netherlands v Commission, T‑476/17 R, EU:T:2018:407, paragraph 81 and the case-law cited). Since imminent disappearance from the market does indeed constitute damage that is both irremediable and serious, adoption of the interim measure sought appears justified in such a situation (see order of 28 April 2009, United Phosphorus v Commission, T‑95/09 R, not published, EU:T:2009:124, paragraph 34 and the case-law cited).

81      In the present case, the applicant claims that it is at risk of suffering the irreparable harm of having to cease trading since its viability is threatened by the very fact of not having obtained, in respect of its product Cuprior, the market exclusivity associated with the granting of the designation of orphan medicinal product.

82      However, it is apparent from the assessment of the President of the General Court in paragraphs 26 to 41 above as regards the alleged harm in relation to the risk of insolvency that the applicant is not, prima facie, in such a situation.

83      In the second place, the applicant claims, in essence, that the entry onto the EU market of a competitor product would create a situation that is virtually irreversible and, therefore, it would suffer irreparable harm and the action in the main case would be rendered nugatory.

84      First, the applicant claims that if Univar’s product entered the market in one of the Member States other than the United Kingdom, it would be extremely difficult to reverse that process should the applicant ultimately be successful in its action for annulment. In order to quash the marketing authorisations granted via mutual recognition, the applicant would have to bring proceedings in each and every Member State concerned. According to the applicant, pursuing these legal remedies would be legally very challenging in view of the case-law arising from the judgment of 16 October 2008, Synthon (C‑452/06, EU:C:2008:565), which suggests that national authorities of a Member State have a very limited margin of discretion as to whether or not to grant a marketing authorisation when such an authorisation has been approved by the national authority of the reference Member State (in this case, the Medicines and Healthcare Products Regulatory Agency (MHRA)).

85      However, it is apparent from the material in the file that Univar has chosen not to seek marketing authorisation via the mutual recognition procedure but, on the contrary, to follow the centralised authorisation procedure. Therefore, the fear expressed by the applicant as to the difficulty of reversing the process of quashing national authorisations appears, a priori, to be unfounded.

86      Moreover, the applicant will be able to oppose any marketing authorisation issued under the centralised procedure by bringing an action for annulment of the Commission’s decision before the General Court.

87      Second, the applicant expresses the same fears in relation to the market entry of competitor medicinal products made by manufacturers of generics who obtain marketing authorisations for a similar product, using a generic version of Cuprior. In that situation, the applicant believes that it risks suffering irreparable harm in so far as it will have lost the benefits of its monopoly right as well as the possibility of applying the preferential pricing that it would be able to negotiate due to the product’s orphan status. In its view, its financial interests would be irremediably harmed, even if its action for annulment in the main proceedings was ultimately successful and the marketing authorisations could be quashed.

88      First of all, as regards marketing authorisations for generic products competing with Cuprior, that situation is, at this stage, hypothetical and cannot, without further particulars in that respect, justify the granting of the measures sought in the context of the present application for interim measures, in accordance with the case-law cited in paragraph 20 above.

89      Next, even if such applications were made, it must be borne in mind that the procedures in question are regulated and take a certain amount of time to complete. Reference is therefore made to the considerations set out in paragraph 68 above.

90      Last, as regards the loss of the benefits linked to the grant of market exclusivity and the possibility of applying preferential pricing, reference is made, respectively, to paragraphs 69 and 74 above, and to paragraphs 55 and 56 above, where it is concluded that the contested decision did not lead to the emergence of the harm feared by the applicant.

91      Third, the applicant submits that if it is thus unable to restore the status quo ante after obtaining judgment in its favour in the main action, it will never be able to reassert its exclusivity right, which would greatly affect its ability to recoup its investment.

92      First of all, as regards restoration of the status quo ante, it is appropriate to recall the above considerations in relation to the effects of a judgment granting the applicant’s application in the main proceedings. In that regard, reference is made to paragraph 64 above, where it is pointed out that, in the Commission’s own view — it being for the Commission, under Article 266 TFEU, to take the measures required to give effect to a judgment delivered in an action for annulment — that institution will be required to take a new decision with retroactive effect in order to ensure that its effects cover the period during which the main action was pending before the General Court.

93      Next, as regards the possibility of the applicant asserting its exclusivity right, on the assumption that it is granted that right following a new Commission decision, it must be pointed out that the applicant could rely on the effects of such a decision in the context of national proceedings (see, to that effect, judgment of 6 October 1970, Grad, 9/70, EU:C:1970:78, paragraph 5) where the authorities will be required to apply it, in accordance with the functioning of the specific legal order instituted by the Treaties (see, to that effect, judgment of 15 July 1964, Costa, 6/64, EU:C:1964:66, p. 593), rendering contrary measures inapplicable (see, to that effect, orders of 21 July 2017, Polskie Górnictwo Naftowe i Gazownictwo v Commission, T‑130/17 R, EU:T:2017:541, paragraph 36; of 21 July 2017, Poland v Commission, T‑883/16 R, EU:T:2017:542, paragraph 44; and of 21 July 2017, PGNiG Supply & Trading v Commission, T‑849/16 R EU:T:2017:544, paragraph 38). In any event, if, in order to assert its rights, the applicant was obliged to bring the matter before the national courts, the legal remedy provided for in Article 267 TFEU would be available to it.

94      Last, as regards the impact of the lack of market exclusivity on the applicant’s ability to recoup the investment in relation to its product Cuprior notwithstanding the adoption of a new decision recognising that exclusivity, reference is made, on the one hand, to the detailed analysis in paragraphs 58 to 68 above, which demonstrates the limited nature of that impact in respect of the period before the decision in the main action, and, on the other hand, to the developments set out in paragraphs 92 and 93 above, which explain the lack of impact in respect of the period after that decision.

95      It is apparent from the foregoing that, contrary to the applicant’s claims, the EU market entry of a competitor product would not create an irreversible situation and would not render the action in the main proceedings nugatory.

96      In the third and last place, the applicant regards the harm as irreparable because it will be impossible to adequately identify or quantify it, so that it will not be possible to make good the harm by bringing an action for damages. The applicant submits that it would be extremely difficult, if not impossible, to quantify the loss of profit if its current and future investors were deterred from investing, thus derailing its product development plans.

97      In that regard, it must be pointed out that harm of a financial nature may in particular be considered to be irreparable if the harm, 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).

98      It is true that the uncertainty of obtaining compensation for pecuniary damage 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 of Justice. At the interlocutory stage, the possibility of subsequently obtaining compensation for pecuniary damage if an action for damages is brought following annulment of the contested measure is necessarily uncertain. Interlocutory proceedings 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 the interlocutory 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).

99      Yet the situation is different where it is already clear, when the assessment is carried out by the judge hearing the application for interim measures, that, in view of its nature and the manner in which it will foreseeably occur, the harm alleged, should it occur, may not be adequately identified or quantified and that, in practice, it will not therefore be possible to make good that harm 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).

100    In the present case, however, it is not evident from the file that, in view of the nature and the manner in which the alleged harm will foreseeably occur, that harm is likely not to be compensable because, should it occur, it could not be adequately identified or quantified and that, in practice, it will not therefore be possible to make good that harm by bringing an action for damages. On the contrary, the applicant puts forward a certain amount of accounting information ostensibly enabling that harm not only to be identified but also to be quantified in an adequate manner.

101    Whilst it is true that, as the applicant notes, the loss of profit could be highly speculative, its contention is based on two propositions that have been rejected following the assessments made in this order. First, the applicant assumes that the product could not be launched on the market. However, as indicated in paragraphs 58 and 70 above, the President of the General Court finds the reasons given in support of the notion of that impossibility to be unconvincing. Second, the estimates submitted by the applicant cover a period of 10 years. However, if any harm were acknowledged in the context of an action for damages, the compensation for the harm would relate to a much shorter period, leaving less of a margin for speculation. As has been pointed out in paragraphs 62 and 74 above, having regard to the average duration of proceedings before the General Court, the decision in the main case will be delivered some considerable time before the end of that period of 10 years from the adoption of the contested decision, enabling the applicant to bring its product to the market, notwithstanding the fact that the applicant did not request that the case be determined under the expedited procedure.

102    It follows that the applicant has established neither the serious nor the irreparable nature of the harm alleged.

103    In the light of the foregoing, it is apparent that the applicant has not demonstrated that the condition relating to urgency, as defined in paragraph 19 above, was satisfied.

104    In those circumstances, since the conditions for ordering suspension of operation of an act and other interim measures are cumulative, the application for interim measures must be dismissed for lack of urgency, without there being any need to examine in more detail the condition relating to the establishment of a prima facie case or to weigh up the interests involved.

105    In accordance with Article 158(5) of the Rules of Procedure, it is appropriate that the costs 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, 23 November 2018.

*      Language of the case: English.

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