ORDER OF THE VICE-PRESIDENT OF THE COURT
2 February 2024 (*)
(Appeal – Interim relief – Medicinal product for human use – Marketing authorisation – Extension of the marketing protection period – No urgency)
In Case C‑609/23 P(R),
APPEAL under the second paragraph of Article 57 of the Statute of the Court of Justice of the European Union, brought on 4 October 2023,
Zentiva k.s., established in Prague (Czech Republic),
Zentiva Pharma GmbH, established in Frankfurt am Main (Germany),
represented by C. Dumont, T. De Meese, K. Roox, and J. Stuyck, advocaten,
appellants,
the other party to the proceedings being:
European Commission, represented by L. Haasbeek, E. Mathieu and A. Spina, acting as Agents,
defendant at first instance,
THE VICE-PRESIDENT OF THE COURT,
after hearing the Advocate General, M. Szpunar,
makes the following
Order
1 By their appeal, Zentiva k.s. and Zentiva Pharma GmbH seek to have set aside the order of the President of the General Court of the European Union of 24 July 2023, Zentiva and Zentiva Pharma v Commission (T‑278/23 R, ‘the order under appeal’, EU:T:2023:420), by which the President of the General Court dismissed their application for suspension of operation of Commission Implementing Decision C(2023) 3067 final of 2 May 2023 amending Commission Implementing Decision C(2014) 601 final of 30 January 2014 granting marketing authorisation for the medicinal product for human use Tecfidera – Dimethyl fumarate (‘the decision at issue’) 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 by Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018 (OJ 2019 L 4, p. 24) (‘Regulation No 726/2004’), and any subsequent decision or act extending or replacing the decision at issue in so far as they concern them, and, second, an injunction requiring the European Commission to refrain from taking any other measures which would amount to a withdrawal of the marketing authorisations (‘MA’) held by the appellants or a prohibition on placing generic Dimethyl fumarate products on the market.
Legal context
Directive 2001/83/EC
2 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), as amended by Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 (OJ 2007 L 324, p. 121 and corrigendum OJ 2009 L 87, p. 174) (‘Directive 2001/83’), provides, in Article 6(1):
‘No medicinal product may be placed on the market of a Member State unless [an MA] has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004 …
When a medicinal product has been granted an initial [MA] in accordance with the first subparagraph, any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions shall also be granted an authorisation in accordance with the first subparagraph or be included in the initial [MA]. All these [MAs] shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10(1).’
3 Article 10(1) of the directive provides:
‘… the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised … for not less than eight years in a Member State or in the Community.
A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product.
…
The ten-year period referred to in the second subparagraph shall be extended to a maximum of eleven years if, during the first eight years of those ten years, the [MA] holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.’
Regulation No 726/2004
4 Article 14(11) of Regulation No 726/2004 provides:
‘Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with the provisions of this Regulation shall benefit from an eight-year period of data protection and a ten-year period of marketing protection, in which connection the latter period shall be extended to a maximum of 11 years if, during the first eight years of those ten years, the [MA] holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.’
Background to the dispute
5 The background to the dispute is set out in paragraphs 2 to 17 of the order under appeal. For the purposes of the present proceedings, that background may be summarised as follows.
6 On 30 January 2014, at the request of Biogen Idec Ltd, the Commission adopted Implementing Decision C(2014) 601 final granting marketing authorisation under Regulation No 726/2004 for Tecfidera – dimethyl fumarate (‘the implementing decision of 30 January 2014’). In recital 3 of that implementing decision, the Commission states that the medicinal product at issue (‘Tecfidera’), on the one hand, and the already authorised medicinal product known as Fumaderm, on the other, do not belong to the same global MA as described in Article 6(1) of Directive 2001/83.
7 On 27 November 2017, Pharmaceutical Works Polpharma S.A. submitted a request to the European Medicines Agency (EMA) seeking confirmation that that company was eligible to submit an MA application under the centralised procedure for a generic medicinal product derived from Tecfidera.
8 By decision of 30 July 2018, the EMA informed Pharmaceutical Works Polpharma that it was unable to validate that application 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 MA 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 (‘the EMA decision of 30 July 2018’).
9 The EMA decision of 30 July 2018 was annulled by the judgment of the General Court of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), by which the General Court upheld a plea of illegality in respect of the implementing decision of 30 January 2014, which constitutes the legal basis thereof, in so far as, in that implementing decision, the Commission had considered that Tecfidera was not covered by the same global MA as Fumaderm.
10 On 13 May 2022, by Commission Implementing Decision C(2022) 3251 final amending the implementing decision of 30 January 2014, the Commission rejected the application submitted by Biogen Netherlands BV for a one-year extension of marketing protection for Tecfidera.
11 Following the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), the appellants obtained several national MAs for their generic Dimethyl fumarate medicinal products with Tecfidera as reference medicinal product (‘the generic medicinal products in question’). After obtaining those MAs, Zentiva Pharma began marketing the generic medicinal products in question in Germany.
12 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). Disposing of the case and ruling on the action at first instance, the Court of Justice also rejected the single plea in law alleging illegality of the implementing decision of 30 January 2014 and, therefore, the action for annulment of the EMA decision of 30 July 2018.
13 On 2 May 2023, the Commission adopted the decision at issue, by which it amended the implementing decision of 30 January 2014 by granting Biogen Netherlands an additional year of marketing protection for Tecfidera, until 2 February 2025.
The proceedings before the General Court and the order under appeal
14 By application lodged at the Registry of the General Court on 15 May 2023, the appellants brought an action for annulment of the decision at issue, and of any other subsequent decision or act extending or replacing the decision at issue, in so far as they concern it.
15 By separate document lodged at the Registry of the General Court on the same day, the appellants submitted an application for interim measures seeking, first, suspension of operation of the decision at issue and any subsequent decision or act extending or replacing the decision at issue in so far as they concern them, and, second, an injunction requiring the Commission to refrain from taking any other measures which would amount to a withdrawal of the MAs held by the appellants or a prohibition on placing generic Dimethyl fumarate products on the market.
16 By the order under appeal, the President of the General Court dismissed that application for interim measures, on the ground that the appellants had failed to establish that the condition relating to urgency was satisfied.
Forms of order sought and procedure before the Court of Justice
17 Zentiva and Zentiva Pharma claim that the Court should:
– set aside the order under appeal;
– grant the application for interim measures;
– in the alternative, refer the case back to the General Court; and
– order the Commission to pay the costs.
18 The Commission contends that the Court should:
– dismiss the appeal; and
– order Zentiva and Zentiva Pharma to pay the costs.
19 By document lodged at the Registry of the Court of Justice on 10 November 2023, Biogen Netherlands sought leave to intervene in the present case in support of the form of order sought by the Commission. Given that the present order closes the appeal proceedings, there is no longer any need to adjudicate on that application and, as a result, on the application for confidential treatment vis-à-vis Biogen Netherlands submitted by Zentiva and Zentiva Pharma.
The appeal
20 In support of their appeal, the appellants raise four grounds, alleging (i) an error of law allegedly committed in the course of the examination of the admissibility of the main proceedings, (ii) an error of law allegedly committed in the course of the examination of the condition relating to urgency, (iii) infringement of the obligation to state reasons and (iv) breach of the right to effective judicial protection.
21 It is appropriate to begin by examining the third ground of appeal.
Arguments
22 By their third ground of appeal, the appellants submit that the order under appeal is vitiated by a failure to give adequate reasons.
23 In that regard, they observe that the reasons why the President of the General Court considered that the condition relating to urgency had not been satisfied are based solely on the effects of the decision at issue on the MA of the generic medicinal products in question and the financial damage which might result from the payment of damages by the appellants.
24 However, those reasons do not in any way address crucial arguments submitted in the application for interim measures. More specifically, the appellants submit that the President of the General Court did not respond to the arguments alleging blatant and serious infringement of Article 14(11) of Regulation No 726/2004, the risk of the appellants incurring criminal liability on account of the retroactive effect of the decision at issue and the consequences thereof on healthcare systems. In that context, the President of the General Court considered only a possible order for a financial penalty, incorrectly failing to take into account the risk that civil injunction proceedings might be brought or penalties might be imposed by national authorities.
25 The Commission is of the view that the order under appeal states adequate reasons.
26 It submits that the President of the General Court implicitly rejected the effect claimed by the appellants of the allegedly serious nature of the prima facie case on the condition relating to urgency, recalling the traditional interpretation of that condition and the cumulative nature of the conditions for granting interim measures.
27 In addition, it submits that the President of the General Court ruled on the lack of relevance of potential proceedings brought by Biogen Netherlands or the national authorities and implicitly considered that the alleged negative effects on third parties are irrelevant in the present case.
Assessment
28 It should be noted, first, that, in the context of an appeal, the purpose of review by the Court of Justice is, inter alia, to ascertain whether the General Court addressed, to the requisite legal standard, all the arguments raised by the appellant and, secondly, that the plea alleging that the General Court failed to rule on arguments relied on at first instance amounts essentially to relying on a breach of the obligation to state reasons, which derives from Article 36 of the Statute of the Court of Justice of the European Union, applicable to the General Court by virtue of the first paragraph of Article 53 of that statute, and from Article 117 of the Rules of Procedure of the General Court (see, to that effect, order of the Vice-President of the Court of Justice of 14 June 2016, Chemtura Netherlands v EFSA, C‑134/16 P(R), EU:C:2016:442, paragraph 46 and the case-law cited).
29 That obligation to state reasons does not require the General Court to provide an account which follows exhaustively and one by one all the arguments put forward by the parties to the case and the General Court’s reasoning may therefore be implicit on condition that it enables the persons concerned to know why it has not upheld their arguments and provides the Court of Justice with sufficient material for it to exercise its power of review (see, to that effect, order of the Vice-President of the Court of Justice of 14 June 2016, Chemtura Netherlands v EFSA, C‑134/16 P(R), EU:C:2016:442, paragraph 47 and the case-law cited).
30 In the present case, the President of the General Court considered, in paragraph 36 of the order under appeal, that the decision at issue, as such, has no effect on the legality of the appellants’ MAs. Moreover, he observed, in paragraphs 37 to 39 of that order, that current or future steps taken by Biogen Netherlands or by the national authorities do not stem directly from the decision at issue and that any order for damages made against the appellants would lead to only financial damage.
31 However, it must be noted that, as submitted by the appellants, they had, in their application for interim measures, argued expressly that the decision at issue was vitiated by serious illegality and that this was sufficient per se to establish that the condition relating to urgency was satisfied.
32 However, the order under appeal does not contain any explicit response to that argument, which is not, moreover, referred to in paragraphs 33 and 34 of that order, by which the President of the General Court set out the appellants’ line of argument.
33 In addition, given that it is apparent from the grounds in paragraphs 30 to 36 of that order that when the President of the General Court examined whether the condition relating to urgency was satisfied, he did not rule on the relevance or well-founded nature of the illegality argued by the appellants, those grounds cannot be understood as implicitly rejecting the argument referred to in paragraph 32 of the present order.
34 In those circumstances, the reasoning of the order under appeal does not allow the appellants to ascertain why the President of the General Court did not uphold that argument and does not provide the Court of Justice with sufficient material for it to exercise its power of review regarding whether those grounds are well founded.
35 It follows that the decision at issue is vitiated by a failure to state reasons.
36 As the President of the General Court thus did not respond to one of the arguments relied on by the appellants to show that the condition relating to urgency was satisfied and the application for interim measures was rejected on the ground that the appellants had not established that that condition had been satisfied, that failure to state reasons renders the operative part of the order under appeal unfounded.
37 It follows that the third ground of appeal must be upheld and, consequently, the order under appeal must be set aside in its entirety, without there being any need to examine the other arguments alleging failure to state reasons in that order or the other grounds of appeal.
The application for interim measures brought before the General Court
38 In accordance with the first paragraph of Article 61 of the Statute of the Court of Justice of the European Union, where the Court of Justice sets aside a decision of the General Court, it may itself give final judgment in the matter, where the state of the proceedings so permits, or refer the case back to the General Court for judgment. That provision also applies to appeals brought under the second paragraph of Article 57 of the Statute of the Court of Justice of the European Union (order of the Vice-President of the Court of Justice of 24 May 2022, Puigdemont i Casamajó and Others v Parliament and Spain, C‑629/21 P(R), EU:C:2022:413, paragraph 172 and the case-law cited).
39 In the present case, the Vice-President of the Court has the necessary information to give final judgment on the application for interim measures submitted by Zentiva and Zentiva Pharma.
40 To that end, it should be recalled that Article 156(4) of the Rules of Procedure of the General Court 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. Thus, according to settled case-law of the Court of Justice, the court hearing an application for interim relief may order the 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 damage to the interests of the party making the application, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, so that applications for interim measures must be dismissed if any one of them is not satisfied. The court hearing an application for interim relief must also, where appropriate, weigh up the interests involved (order of the Vice-President of the Court of Justice of 24 May 2022, Puigdemont i Casamajó and Others v Parliament and Spain, C‑629/21 P(R), EU:C:2022:413, paragraph 175 and the case-law cited).
41 In the context of its examination of those conditions, the court 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 EU law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (order of the Vice-President of the Court of 16 July 2021, Symrise v ECHA, C‑282/21 P(R), EU:C:2021:631, paragraph 28 and the case-law cited).
42 In the present case, it is appropriate to begin by examining the condition relating to urgency.
Arguments
43 The appellants submit, in the first place, that it is apparent from the case-law of the Court of Justice that it is appropriate to suspend an act which does not even have the appearance of legality, without it being necessary to establish risk that serious and irreparable damage may occur. The decision at issue was adopted in blatant and serious breach of Article 14(11) of Regulation No 726/2004, as an extension of the marketing protection period may be granted only where the MA holder has obtained, during the first eight years of that period, an authorisation for one or more new therapeutic indications, which is not the case here.
44 In the second place, the appellants argue that it is necessary to grant the interim measures sought in order to ensure full effectiveness of the decision to be given in the main proceedings. Given that the decision at issue extends the marketing protection period of Tecfidera until 2 February 2025 and having regard to the usual processing time for cases before the General Court, the decision to be given in the main proceedings will probably not be made in time to prevent major adverse consequences of the decision at issue from occurring, in so far as that decision prohibits the appellants retroactively from using, until 2 February 2025, the national MAs granted to them.
45 In the third place, the appellants submit that they would suffer irreparable damage if they were unlawfully required, due to the application of the decision at issue, no longer to place products on the market for an additional one-year period. That damage would consist, inter alia, of loss of profit, complete loss of market share, additional costs related to re-launching the generic medicinal products in question on the market and harm to the their reputation.
46 In that connection, the appellants stress that sales of the generic medicinal products in question increased sharply and allowed them to occupy significant shares of the market in question in certain Member States, Germany in particular. However, various factors would prevent them from subsequently regaining that market share, which would cause them damage which could not be easily assessed or repaired.
47 They submit, more specifically, that, following the withdrawal of the generic medicinal products in question from the market, they will no longer be able to enjoy the competitive advantage afforded to first movers on a market, that patients and national health systems will incur considerable additional costs, that their reputation will suffer long term, that they will not be able to meet their contractual and extra-contractual obligations to supply the generic medicinal products in question, that there could be medicine shortages in certain Member States, that stocks of medicinal products will have to be destroyed, that their fundamental rights and freedoms will be disregarded and that they may be subject to sanctions, including criminal sanctions, for a situation beyond their control since the decision at issue is retroactive.
48 According to the appellants, interim measures have also been granted in similar circumstances by the General Court and national courts.
49 The Commission submits, first, that the existence of a particularly strong prima facie case does not warrant interim measures being granted without it being shown that there is serious and irreparable damage. The EU Courts have loosened that requirement in only three specific fields, which are not the subject of the present case. In any event, the appellants have not established that the decision at issue is vitiated by blatant and extremely serious illegality.
50 Next, the very purpose of interim proceedings is to ensure the full effectiveness of the decision to be given in the main proceedings and it is therefore for the appellants to show that the condition relating to urgency is satisfied.
51 Last, the Commission is of the view that the appellants have not established that there is a risk of serious and irreparable damage occurring.
52 The risk argued therefore stems, very broadly, not from the decision at issue, but rather from the application of the rules of marketing protection provided for by Article 14(11) of Regulation No 726/2004, which already prevent the marketing of the generic medicinal products in question before 3 February 2024.
53 Moreover, the damage claimed is purely financial and is not irreparable, in so far as it is not established that that damage threatens the existence of the appellants or that it is not quantifiable. Similarly, the appellants have not shown that structural obstacles would prevent them from regaining lost market share. What is more, a pharmaceutical company cannot rely on harm suffered by third parties, such as patients or health systems. The risk of a significant change to the appellants’ reputation is also hypothetical and unfounded.
Assessment
54 As a preliminary matter, it must be stated that the appellants seek, in paragraph 4 of the form of order sought in the application for interim measures, an injunction requiring the Commission to refrain from taking any other measures which would amount to a withdrawal of the MA of the generic medicinal products in question or a prohibition for the appellants on placing such generic products on the market. However, the judge hearing an application for interim measures does not have jurisdiction to order an EU institution to suspend a procedure which does not depend on a contested measure. Nevertheless, the appellants enjoy judicial protection granted to them by primary EU law against such a measure, in so far as that measure may be the subject of an action for annulment accompanied by an application for interim measures, which may, where appropriate, lead to the granting of interim measures pursuant to Article 156(2) of the Rules of Procedure of the General Court (see, to that effect, order of the Vice-President of the Court of Justice of 28 September 2023, Council v Mazepin, C‑564/23 P(R), EU:C:2023:727, paragraph 83).
55 It therefore falls to be determined whether the condition relating to urgency is satisfied only with regard to the other interim measures sought by the appellants, which seek, in essence, to obtain suspension of operation of the decision at issue or any other measure replacing that decision.
56 Regarding, in the first place, the claim that urgency must be recognised in the present case due to a blatant and serious infringement of Article 14(11) of Regulation No 726/2004, it is apparent from the Court’s case-law that the strength of a prima facie case affects the assessment of urgency. The urgency that may be pleaded by an applicant must thus be taken into consideration by the court hearing the application for interim measures all the more if the prima facie case raised by the pleas and arguments relied on appears particularly serious (order of the Vice-President of the Court of Justice of 12 October 2022, Mariani v Parliament, C‑525/22 P(R), EU:C:2022:797, paragraph 69 and the case-law cited).
57 The fact remains that, in accordance with Article 156(4) of the Rules of Procedure of the General Court, the conditions relating to a prima facie case and to urgency are distinct and cumulative, so that the party seeking interim measures still needs to prove the imminence of serious and irreparable damage (order of the Vice-President of the Court of Justice of 12 October 2022, Mariani v Parliament, C‑525/22 P(R), EU:C:2022:797, paragraph 70 and the case-law cited).
58 Nevertheless, where a decision appears, having regard to the nature of the complaints made against it, to lack even the appearance of legality, the court hearing the application for interim measures must suspend their operation forthwith, without the need for the party seeking interim protection to show that that protection must be granted to that party in order to avoid the occurrence of serious and irreparable damage (order of the Vice-President of the Court of Justice of 12 October 2022, Mariani v Parliament, C‑525/22 P(R), EU:C:2022:797, paragraph 71 and the case-law cited).
59 It follows from that case-law that only exceptionally serious illegality may warrant an order for suspension of operation of a decision, without the risk of the occurrence of serious and irreparable damage being established, and that it is therefore not sufficient in that regard to show a particularly strong prima facie case (order of the Vice-President of the Court of Justice of 12 October 2022, Mariani v Parliament, C‑525/22 P(R), EU:C:2022:797, paragraph 72).
60 In the present case, if the Court finds, as the appellants claim, that, first, the extension of the marketing protection period is subject to the condition that, during a defined period, one or more new therapeutic indications must be obtained and, second, that that condition was not satisfied regarding Tecfidera, it is true that such irregularity would warrant, at first glance, annulment of the decision at issue granting Biogen Netherlands an additional year of marketing protection for Tecfidera.
61 That being said, the illegality claimed, namely the failure to have regard to the conditions to which the adoption of a decision is subject, does not appear, in any event, to be exceptional in terms of its nature and seriousness, to the effect that the decision at issue lacks even the appearance of legality.
62 The appellants also rely on the allegedly blatant nature of the illegality claimed, without, however, submitting arguments to show that that illegality is exceptional in terms of its nature and seriousness.
63 As a result, even assuming that Article 14(11) of Regulation No 726/2004 has been infringed, such infringement is not exceptional such as to establish that the condition relating to urgency has been satisfied in the present case.
64 Regarding, in the second place, the argument that an order for the interim measures sought is necessary in order to ensure effective judicial protection for the appellants, it must be borne in mind 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 Court. It is for the purpose of attaining that objective that urgency must be assessed in the light of the need for an interlocutory order to avoid serious and irreparable damage to the party seeking the interim relief. It is for that party to prove that it cannot await the outcome of the main proceedings without suffering such damage (order of the Vice-President of the Court of 16 July 2021, Symrise v ECHA, C‑282/21 P(R), EU:C:2021:631, paragraph 40 and the case-law cited).
65 It follows that it is for the appellants, for the purpose of establishing that there is a lacuna in judicial protection, as they claim, to show that there is a risk that serious and irreparable damage may occur. The fact that the decision at issue is claimed to prohibit retroactively the appellants from using, until 2 February 2025, the national MAs granted to them – assuming that such a fact is established – should therefore be taken into account in order to assess that risk. Failing such a demonstration, the general claim that the appellants could be deprived of effective judicial protection cannot justify an order for interim measures.
66 In addition, in so far as the appellants’ argument relying on the principle of effective judicial protection should be understood as being based on the fact that the judicial decision in the main proceedings might be handed down after the decision at issue has exhausted its effects, it is appropriate to specify that, inasmuch as, inter alia, any annulment of the decision at issue would be, in principle, retroactive, that fact cannot, in itself, establish that it is necessary to suspend the effects of that decision or to order other interim measures intended to limit those effects.
67 In the third place, it is appropriate to examine the appellants’ line of argument alleging a risk that serious and irreparable damage could occur while awaiting the outcome of the main proceedings.
68 In that connection, the appellants and the Commission base their respective lines of argument on the fact that the effect of the decision at issue is to prohibit the appellants from marketing the generic medicinal products in question or prevent such marketing during the marketing protection period of Tecfidera flowing from Article 14(11) of Regulation No 726/2004 and Article 10(1) of Directive 2001/83, even if the national MA of those medicinal products was not amended.
69 It does not, however, appear necessary, in order to rule on the condition relating to urgency, to determine whether the decision at issue does have such an effect, in so far as, even assuming this to be the case, the appellants have not established that the application of the decision at issue pending the outcome of the decision in the main proceedings would cause them serious and irreparable damage.
70 It must, first, be noted that it is not apparent from Article 14(11) of Regulation No 726/2004 or Article 10(1) of Directive 2001/83 that the regime governing the marketing of generic medicinal products during the initial 10-year period of marketing protection of the reference medicinal product differs from the regime applicable during the additional one-year protection period which may be granted to the reference medicinal product in accordance with those provisions.
71 In the present case, it is apparent from the wording itself of the decision at issue that its purpose is to extend by one year, from 3 February 2024, the marketing protection period of Tecfidera stemming from the MA granted by the implementing decision of 30 January 2014.
72 Such extension does, admittedly, presuppose that the Commission considered, when adopting the decision at issue, that Tecfidera enjoyed such a protection period and that it would not expire before 3 February 2024.
73 However, in accordance with Article 14(11) of Regulation No 726/2004 and Article 10(1) of Directive 2001/83, the initial marketing protection period of a medicinal product does not stem from a decision extending that period, but from the MA of that medicinal product. As a result, the marketing protection of Tecfidera before 3 February 2024 – assuming that it is established – stems necessarily from the implementing decision of 30 January 2014, not from the decision at issue.
74 The fact that the General Court, in its judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), upheld the plea of illegality of that implementing decision and annulled the EMA decision of 30 July 2018 and that that judgment was subsequently set aside by the 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), is not liable to call that assessment into question.
75 In holding, in paragraph 106 of the latter judgment, that the Commission had not made a manifest error of assessment in finding that Tecfidera was not part of the same global MA as Fumaderm and consequently rejecting the plea of illegality of the implementing decision of 30 January 2014, the Court merely confirmed the legality of that implementing decision. Therefore, following that judgment, that implementing decision produces its effects without it being necessary for the Commission to adopt a new implementing decision for that purpose.
76 In those circumstances, although, as the appellants point out, the Commission sets out, in recital 6 of the decision at issue, the interpretation it intends to make of that judgment, the effects of the implementing decision of 30 January 2014 are not dependent on that interpretation.
77 It follows that, while the effect of the decision at issue would be to prohibit or prevent the marketing of the generic medicinal products in question between 3 February 2024 and 2 February 2025, should the premiss set out in paragraph 68 of the present order be well founded, that decision could not, however, produce such an effect before 3 February 2024.
78 In order to establish that there is a risk that their reputation would be harmed in the long term, that contractual and extra-contractual obligations would be infringed and that stocks of medicinal products would be destroyed, the appellants rely, in their application for interim measures, on the foreseeable effects of a withdrawal of the generic medicinal products in question from the market, which they would have to undertake in order to comply with the marketing protection that Tecfidera would enjoy.
79 It is nevertheless apparent from paragraphs 73, 76 and 77 of the present order that, even assuming that the marketing protection of Tecfidera requires them to withdraw the generic medicinal products in question from the market, such withdrawal was already required from at least 16 March 2023, once the legality of the implementing decision of 30 January 2014 had been confirmed.
80 In that context, the line of argument submitted by the appellants does not make it possible to establish how the extension of the period of marketing protection of Tecfidera resulting from the decision at issue has a decisive effect regarding the risks set out in paragraph 78 of the present order and, consequently, how suspension of operation or limitation of certain effects of that decision could prevent those risks from coming about, while only interim measures which would serve to prevent the alleged damage from occurring may be ordered by the court hearing the application for interim measures (see, to that effect, order of the President of the Court of Justice of 12 February 2003, Marcuccio v Commission, C‑399/02 P(R), EU:C:2003:90, paragraph 26).
81 The same applies to the risk of loss of market share claimed by the appellants.
82 In that regard, the factors raised in the application for interim measures regarding the market share in question acquired by the appellants or the advantage resulting from their status as first mover on that market do not make it possible to establish that that market share could be retained until 3 February 2024 or, conversely, that the market share retained by that date would probably be lost before 2 February 2025.
83 Admittedly, the extension of the period of marketing protection of Tecfidera is liable, assuming that the premiss set out in paragraph 68 of the present order is well founded, to delay the date on which the market share potentially lost by the appellants could be regained by that company.
84 However, it is apparent from the Court’s case-law that, where the party applying for interim relief claims loss of its market share, it must demonstrate that obstacles of a structural or legal nature prevent it from regaining a significant proportion of that market share (order of the President of the Court of Justice of 24 March 2009, Cheminova and Others v Commission, C‑60/08 P(R), EU:C:2009:181, paragraph 64).
85 The mere fact that the date on which a fresh entry on the market in question will be possible would be delayed cannot, per se, constitute such an obstacle of a structural or legal nature. In addition, in so far as the appellants intend to rely on the risks referred to in paragraph 78 of the present order as representing such obstacles of a structural or legal nature, such a line of argument cannot succeed, since it is apparent from paragraphs 79 and 80 of the present order that the existence of a link between those risks and the decision at issue has not been established.
86 Second, regarding the risk that the appellants would be exposed to an order for penalties, including criminal penalties, for circumstances beyond their control, it must be stated that, in so far as the effect of the decision at issue is to extend the marketing protection period of Tecfidera from 3 February 2024, it is not liable to expose the appellants to proceedings for events prior to that date.
87 Moreover, it is clear that the application for interim measures does not specify the basis on which such penalties would be imposed, merely raising the hypothesis that an order for such penalties might be made, which is not sufficient to establish that the risk relied on is sufficiently foreseeable.
88 Third, regarding the alleged negative effects of the decision at issue on patients and national health systems and the risk of medicine shortages, it should, admittedly, be noted that interests regarded as general on a national level may be relied on by Member States in interim proceedings (order of the Vice-President of the Court of Justice of 13 April 2021, Lithuania v Parliament and Council, C‑541/20 R, EU:C:2021:264, paragraph 21).
89 However, a company such as Zentiva or Zentiva Pharma cannot rely on such interests in support of an application for interim measures. It is apparent from the Court’s case-law that, in order for its application for interim relief to be declared well founded, a company must furnish proof that it cannot await the conclusion of the main action without personally suffering damage which would have serious and irreparable effects for it (order of the President of the Court of Justice of 24 March 2009, Cheminova and Others v Commission, C‑60/08 P(R), EU:C:2009:181, paragraph 35).
90 Fourth, given that the appellants claim that the application of the decision at issue would lead to an infringement of their fundamental rights and freedoms, it must be borne in mind that it is insufficient to allege infringement of fundamental rights in the abstract for the purpose of establishing that the harm which could result would necessarily be serious and irreparable (order of the Vice-President of the Court of Justice of 12 June 2018, Nexans France and Nexans v Commission, C‑65/18 P(R), EU:C:2018:426, paragraph 36 and the case-law cited).
91 Fifth, in so far as the appellants claim that they will suffer damage resulting from a loss of profit and the costs of re-launching the generic medicinal products in question on the market, it is true that the extension of the period during which those medicinal products cannot be marketed could increase the amount of that loss of profit and of those costs.
92 Nevertheless, such damage would be purely financial in nature.
93 It is apparent from the Court’s settled case-law that damage of a financial nature cannot, other than in exceptional circumstances, be regarded as irreparable since, as a general rule, pecuniary compensation is capable of restoring the aggrieved person to the situation that prevailed before he or she suffered the damage (see, to that effect, order of the Court hearing an application for interim measures of 24 October 2023, VC v EU-OSHA, C‑456/23 P(R), EU:C:2023:831, paragraph 85 and the case-law cited).
94 In that respect, where the damage referred to is of a financial nature, the interim measures sought are justified, inter alia, where, in the absence of those measures, the appellant would be in a position that would jeopardise its financial viability before final judgment is given in the main action in the light, inter alia, of the size and turnover of its undertaking and the characteristics of the group to which it belongs (order of the Court hearing an application for interim measures of 24 October 2023, VC v EU-OSHA, C‑456/23 P(R), EU:C:2023:831, paragraph 86 and the case-law cited).
95 In the present case, the appellants do not submit any argument to establish that the financial damage they claim would jeopardise their financial viability.
96 However, it should be noted that harm of a financial nature may, inter alia, be regarded as irreparable if the harm, even when it occurs, cannot be quantified (order of the Court hearing an application for interim measures of 24 October 2023, VC v EU-OSHA, C‑456/23 P(R), EU:C:2023:831, paragraph 91 and the case-law cited).
97 It is true that the uncertainty of obtaining compensation for financial 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. At the interlocutory stage, the possibility of subsequently obtaining compensation for financial 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 (see, to that effect, order of the Court hearing an application for interim measures of 24 October 2023, VC v EU-OSHA, C‑456/23 P(R), EU:C:2023:831, paragraph 92 and the case-law cited).
98 However, the situation is different where it is already clear, when the assessment is carried out by the court 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 (order of the Court hearing an application for interim measures of 24 October 2023, VC v EU-OSHA, C‑456/23 P(R), EU:C:2023:831, paragraph 92 and the case-law cited).
99 In the present case, while the detailed rules for calculating the compensation that the appellants could potentially obtain are still to be set out, the fact remains that the appellants plead damage which, having regard to its nature and the manner in which it could foreseeably occur, could be determined in principle on the basis of the sales volume of the generic medicinal products in question before their withdrawal from the market, on the projected change to that volume and on the amount of the investments necessary to place those medicinal products on the market again.
100 In those circumstances, it cannot be held that the alleged financial damage cannot be quantified.
101 As a result, the appellants have not shown that the damage is irreparable.
102 Consequently, the appellants have not established that they cannot wait for the outcome of the main proceedings without having to suffer serious and irreparable damage.
103 In the light of all the foregoing, the appellants have not shown that the condition relating to urgency was satisfied in the present case.
104 Having regard to the fact that the conditions for the grant of interim measures are cumulative, the application for interim measures must therefore be dismissed, without it being necessary to examine the conditions relating to a prima facie case and the weighing up of the interests.
Costs
105 In accordance with Article 184(2) of the Rules of Procedure of the Court of Justice, where the appeal is well founded and the Court itself gives final judgment in the case, the Court is to make a decision as to costs.
106 Article 138(1) of those rules, which is applicable to appeal proceedings by virtue of Article 184(1) of the same rules, provides that the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Article 138(3) of those rules, applicable to appeal proceedings by virtue of Article 184(1) thereof, provides, in addition, that, where each party succeeds on some and fails on other heads, the parties are to bear their own costs. However, if it appears justified in the circumstances of the case, the Court may order that one party, in addition to bearing its own costs, pay a proportion of the costs of the other party.
107 Moreover, under Article 142 of the Rules of Procedure, which applies to the procedure on appeal pursuant to Article 184(1) of those rules, where a case does not proceed to judgment the costs are to be in the discretion of the Court.
108 In the present case, having regard to the fact that the order under appeal has been set aside and the action at first instance has been dismissed, the appellants and the Commission must each be ordered to bear their own costs relating to the appeal.
109 Regarding the costs relating to the application by Biogen Netherlands for leave to intervene in the appeal, under Article 142 of the Rules of Procedure, it is appropriate to order the appellants, the Commission and Biogen Netherlands each to bear their own costs.
110 As regards the costs relating to the interlocutory proceedings at first instance, it is appropriate to decide, first, in accordance with Article 137 of the Rules of Procedure, applicable to appeal proceedings by virtue of Article 184(1) of those rules, that the costs of the appellants and of the Commission are to be reserved.
On those grounds, the Vice-President of the Court hereby orders:
1. The order of the President of the General Court of the European Union of 24 July 2023, Zentiva and Zentiva Pharma v Commission (T‑278/23 R, EU:T:2023:420), is set aside.
2. There is no longer any need to adjudicate on the application for leave to intervene in the appeal submitted by Biogen Netherlands BV.
3. The application for interim measures is dismissed.
4. Zentiva k.s., Zentiva Pharma GmbH and the European Commission shall each bear their own costs relating to the appeal.
5. Zentiva, Zentiva Pharma, the Commission and Biogen Netherlands shall each bear their own costs relating to the application for leave to intervene in the appeal submitted by Biogen Netherlands.
6. The costs of Zentiva, Zentiva Pharma and the Commission relating to the interlocutory proceedings at first instance are reserved.
Luxembourg, 2 February 2024.
A. Calot Escobar | | L. Bay Larsen |