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‑608/23 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,
Zaklady Farmaceutyczne Polpharma S.A., established in Starogard Gdański (Poland), represented by C. Dumont, T. De Meese, K. Roox and J. Stuyck, advocaten,
appellant,
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 its appeal, Zaklady Farmaceutyczne Polpharma S.A.
seeks to have set aside the order of the President of the General Court of the European Union of 24 July 2023, Zaklady Farmaceutyczne Polpharma v Commission (T‑258/23 R, ‘the order under appeal’, EU:T:2023:418), by which the President of the General Court dismissed its 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 it, and, second, an injunction requiring the European Commission to refrain from taking any other measures which would amount to a withdrawal of the marketing authorisation (‘MA’) held by Zaklady Farmaceutyczne Polpharma 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 20 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      On the same day, at the request of Zaklady Farmaceutyczne Polpharma, the Commission adopted Implementing Decision C(2022) 3253 final granting marketing authorisation under Regulation No 726/2004 for the medicinal product for human use ‘Dimethyl fumarate Polpharma – dimethyl fumarate’ (‘DMF Polpharma’). After obtaining that MA, the appellant began to market the medicinal product DMF Polpharma in several Member States of the European Union.
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, Zaklady Farmaceutyczne Polpharma 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, Zaklady Farmaceutyczne Polpharma 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 it, and, second, an injunction requiring the Commission to refrain from taking any other measures which would amount to a withdrawal of the MA held by Zaklady Farmaceutyczne Polpharma 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 Zaklady Farmaceutyczne Polpharma had failed to establish that the condition relating to urgency was satisfied.
Forms of order sought and procedure before the Court of Justice
17      Zaklady Farmaceutyczne Polpharma claims 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 Zaklady Farmaceutyczne Polpharma 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 Zaklady Farmaceutyczne Polpharma.
The appeal
20      In support of its appeal, Zaklady Farmaceutyczne Polpharma raises 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 its third ground of appeal, Zaklady Farmaceutyczne Polpharma submits that the order under appeal is vitiated by a failure to give adequate reasons.
23      In that regard, it observes 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 DMF Polpharma and the financial damage which might result from the payment of damages by Zaklady Farmaceutyczne Polpharma.
24      However, those reasons do not in any way address crucial arguments submitted in the application for interim measures. More specifically, the appellant submits 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 Zaklady Farmaceutyczne Polpharma 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 appellant 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 42 of the order under appeal, that the decision at issue, as such, has no effect on the legality of the appellant’s MA. Moreover, he observed, in paragraphs 43 to 45 of that order, that current or future steps taken by Biogen Netherlands, national authorities or the Commission do not stem directly from the decision at issue and that any order for damages made against Zaklady Farmaceutyczne Polpharma would lead to only financial damage.
31      However, it must be noted that, as submitted by Zaklady Farmaceutyczne Polpharma, the appellant had, in its 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 39 and 40 of that order, by which the President of the General Court set out Zaklady Farmaceutyczne Polpharma’s line of argument.
33      In addition, given that it is apparent from the grounds in paragraphs 42 to 45 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 Zaklady Farmaceutyczne Polpharma, those grounds cannot be understood as implicitly rejecting the argument referred to in paragraph 31 of the present order.
34      In those circumstances, the reasoning of the order under appeal does not allow Zaklady Farmaceutyczne Polpharma 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 Zaklady Farmaceutyczne Polpharma to show that the condition relating to urgency was satisfied and the application for interim measures was rejected on the ground that that company 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 Zaklady Farmaceutyczne Polpharma.
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      Zaklady Farmaceutyczne Polpharma submits, 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 appellant argues 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.
45      In the third place, Zaklady Farmaceutyczne Polpharma submits that it would suffer irreparable damage if it 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 DMF Polpharma on the market and harm to Zaklady Farmaceutyczne Polpharma’s reputation.
46      In that connection, Zaklady Farmaceutyczne Polpharma stresses that it gains substantial income from the sales of DMF Polpharma. However, various factors would prevent it from subsequently regaining the
share on the market that it allegedly holds, which would cause it damage which could not be easily assessed or repaired.
47      It submits, more specifically, that, following the withdrawal of DMF Polpharma from the market, it 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 its reputation will suffer long term, that it will not be able to meet its contractual and extra-contractual obligations to supply DMF Polpharma, that there could be medicine shortages in certain Member States, that stocks of medicinal products will have to be destroyed, that its fundamental rights and freedoms will be disregarded and that it may be subject to sanctions, including criminal sanctions, for a situation beyond its control since the decision at issue is retroactive.
48      According to the appellant, 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, Zaklady Farmaceutyczne Polpharma has 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 Zaklady Farmaceutyczne Polpharma to show that the condition relating to urgency is satisfied.
51      Last, the Commission is of the view that Zaklady Farmaceutyczne Polpharma has 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 DMF Polpharma 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 Zaklady Farmaceutyczne Polpharma or that it is not quantifiable. Similarly, Zaklady Farmaceutyczne Polpharma has not shown that structural obstacles would prevent it 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 Zaklady Farmaceutyczne Polpharma’s reputation is also hypothetical and unfounded.
Assessment
54      As a preliminary matter, it must be stated that Zaklady Farmaceutyczne Polpharma seeks, 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 DMF Polpharma or a prohibition for the appellant on placing such a generic product 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, Zaklady Farmaceutyczne Polpharma enjoys the judicial protection granted to it 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 Zaklady Farmaceutyczne Polpharma, 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 Zaklady Farmaceutyczne Polpharma claims, 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      Zaklady Farmaceutyczne Polpharma also relies 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 appellant, 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 Zaklady Farmaceutyczne Polpharma, for the purpose of establishing that there is a lacuna in protection, as it claims, to show that there is a risk that serious and irreparable damage may occur. Failing such a demonstration, the general claim that Zaklady Farmaceutyczne Polpharma could be deprived of effective judicial protection cannot justify an order for interim measures.
66      In addition, in so far as Zaklady Farmaceutyczne Polpharma’s 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 Zaklady Farmaceutyczne Polpharma’s 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, Zaklady Farmaceutyczne Polpharma and the Commission base their respective lines of argument on the fact that the effect of the decision at issue is to prohibit that company from marketing DMF Polpharma 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 MA of DMF Polpharma 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, Zaklady Farmaceutyczne Polpharma has not established that the application of the decision at issue pending the outcome of the decision in the main proceedings would cause it 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 Zaklady Farmaceutyczne Polpharma points 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 DMF Polpharma between 3 February 2024 and 2 February 2025, if the premiss set out in paragraph 68 of the present order were 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 its 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, Zaklady Farmaceutyczne Polpharma relies, in its application for interim measures, on the foreseeable effects of a withdrawal of DMF Polpharma from the market, which it 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 DMF Polpharma to be withdrawn 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 Zaklady Farmaceutyczne Polpharma 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 Zaklady Farmaceutyczne Polpharma.
82      In that regard, should Zaklady Farmaceutyczne Polpharma have acquired a significant share on the market in question, which it does not show, the argument based on the advantage resulting from its status as first mover on that market does 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 Zaklady Farmaceutyczne Polpharma 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 Zaklady Farmaceutyczne Polpharma intends 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 Zaklady Farmaceutyczne Polpharma would be exposed to an order for penalties, including criminal penalties, for circumstances beyond its 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 Zaklady Farmaceutyczne Polpharma 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 Zaklady Farmaceutyczne Polpharma 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 Zaklady Farmaceutyczne Polpharma claims that the application of the decision at issue would lead to an infringement of its 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 Zaklady Farmaceutyczne Polpharma claims that it will suffer damage resulting from a loss of profit and the costs of re-launching DMF Polpharma on the market, it is true that the extension of the period during which that medicinal product 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, Zaklady Farmaceutyczne Polpharma does not submit any argument to establish that the financial damage it claims would jeopardise its 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 Zaklady Farmaceutyczne Polpharma could potentially obtain are still to be set out, the fact remains that the appellant pleads 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 DMF Polpharma before its withdrawal from the market, on the projected change to that volume and on the amount of the investments necessary to place that medicinal product on the market again.
100    In those circumstances, it cannot be held that the alleged financial damage cannot be quantified.
101    As a result, Zaklady Farmaceutyczne Polpharma has not shown that the damage is irreparable.
102    Consequently, Zaklady Farmaceutyczne Polpharma has not established that it 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, Zaklady Farmaceutyczne Polpharma has 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, Zaklady Farmaceutyczne Polpharma 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 Zaklady Farmaceutyczne Polpharma, 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 Zaklady Farmaceutyczne Polpharma 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, Zaklady Farmaceutyczne Polpharma v Commission (T‑258/23 R, EU:T:2023:418), 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.      Zaklady Farmaceutyczne Polpharma S.A. and the European Commission shall each bear their own costs relating to the appeal.
5.      Zaklady Farmaceutyczne Polpharma, 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 Zaklady Farmaceutyczne Polpharma and the Commission relating to the interlocutory proceedings at first instance are reserved.
Luxembourg, 2 February 2024.
A. Calot Escobar
L. Bay Larsen
Registrar
Vice-President
*      Language of the case: English.