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

ORDER OF THE PRESIDENT OF THE GENERAL COURT

4 August 2022 (*)

(Interim relief – Medicinal products for human use – Regulation (EC) No 726/2004 – Marketing authorisation for Dimethyl fumarate Mylan – dimethyl fumarate – Application for suspension of operation of a measure – No urgency)

In Case T‑279/22 R,

Biogen Netherlands BV, established in Badhoevedorp (Netherlands), represented by C. Schoonderbeek, lawyer,

applicant,

v

European Commission, represented by L. Haasbeek and A. Sipos, acting as Agents,

defendant,

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order

1        By its application based on Articles 278 and 279 TFEU, the applicant, Biogen Netherlands BV, seeks suspension of the operation of Commission Implementing Decision C(2022) 3252 final of 13 May 2022 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Dimethyl fumarate Mylan – dimethyl fumarate’ as a medicinal product for human use (‘the contested decision’).

 Background to the dispute and forms of order sought

2        The applicant is a biotechnology company which develops and markets various medicinal products, including medicinal products used in the treatment of multiple sclerosis.

3        On 28 February 2012, Biogen Idec Limited lodged with the European Medicines Agency (EMA) an application for marketing authorisation, pursuant to Article 4(1) of 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), for the medicinal product for human use Tecfidera – dimethyl fumarate (‘Tecfidera’), indicated for the treatment of multiple sclerosis.

4        On 30 January 2014, the European Commission adopted Implementing Decision C(2014)601 final granting marketing authorisation under Regulation No 726/2004 for ‘Tecfidera’, a medicinal product for human use (‘the implementing decision of 30 January 2014’). In recital 3 of that implementing decision, the Commission states that Tecfidera, on the one hand, and the already authorised medicinal product known as Fumaderm, on the other, do not belong to the same global marketing authorisation as described in Article 6(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67). A summary of that implementing decision was published in the Official Journal of the European Union on 28 February 2014 (OJ 2014 C 59, p. 1).

5        On 27 November 2017, the company Pharmaceutical Works Polpharma S.A. submitted a request to the EMA seeking confirmation that it was eligible to submit an application for marketing authorisation under the centralised procedure in accordance with Article 3(3) of Regulation No 726/2004 for a generic medicinal product known as Dimethyl Fumarate Pharmaceutical Works Polpharma derived from the reference medicinal product Tecfidera.

6        By letter of 30 July 2018, the EMA informed Pharmaceutical Works Polpharma that it was unable to validate its application for the grant of a marketing authorisation to place on the market a generic medicinal product derived from the reference medicinal product Tecfidera, on the ground that, in essence, according to recital 3 of the implementing decision of 30 January 2014, Tecfidera, on the one hand, and the already authorised medicinal product Fumaderm, on the other, did not belong to the same global marketing authorisation as described in Article 6(1) of Directive 2001/83, and that, consequently, since Tecfidera benefits from an independent eight year period of data protection, that protection period had not yet expired (‘the EMA decision of 30 July 2018’).

7        By application lodged at the Court Registry on 9 October 2018 and registered as Case T‑611/18, Pharmaceutical Works Polpharma brought an action seeking, first, a declaration that the plea of illegality under Article 277 TFEU raised in respect of the implementing decision of 30 January 2014 was admissible and well founded in so far as, in that implementing decision, the Commission considered that Tecfidera was not covered by the same global marketing authorisation as Fumaderm and, second, annulment of the EMA decision of 30 July 2018 refusing to validate its application with a view to obtaining a marketing authorisation for a generic version of the medicinal product Tecfidera.

8        On 5 May 2021, the Court delivered its judgment in Pharmaceutical Works Polpharma v EMA (T‑611/18, under appeal, EU:T:2021:241). By that judgment, the Court upheld the plea of illegality raised by Pharmaceutical Works Polpharma and declared the implementing decision of 30 January 2014 inapplicable in so far as, in that implementing decision, the Commission found that Tecfidera did not belong to the same global marketing authorisation as Fumaderm. Consequently, the EMA decision of 30 July 2018, which was based on the implementing decision of 30 January 2014, was unfounded and was annulled.

9        On 14 July 2021, the Commission and the applicant, as interveners in support of the form of order sought by the EMA, brought appeals against the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, under appeal, EU:T:2021:241). Those appeals are currently pending before the Court (Cases C‑438/21 P and C‑439/21 P).

10      On 15 July 2021, the EMA brought an appeal against the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, under appeal, EU:T:2021:241). That appeal is currently pending before the Court (Case C‑440/21 P).

11      Following the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, under appeal, EU:T:2021:241), Mylan Ireland Limited and two other pharmaceutical companies submitted an application for marketing authorisation for generic versions of the reference medicinal product Tecfidera.

12      On 13 May 2022, the Commission adopted the contested decision granting marketing authorisation for the medicinal product for human use Dimethyl fumarate Mylan – dimethyl fumarate, developed by Mylan Ireland.

13      By application lodged at the Court Registry on 17 May 2022, the applicant brought an action for the annulment of the contested decision.

14      By separate document lodged at the Court Registry on the same day, the applicant brought the present application for interim measures, in which it claims that the President of the General Court should:

–        order suspension of the operation of the contested decision until the Court has given final judgment in the main action;

–        in the alternative, order suspension of the operation of the contested decision pending judgment of the Court of Justice in the appeal brought by the applicant against the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, under appeal, EU:T:2021:241).

15      In its observations on the application for interim measures lodged at the Court Registry on 13 June 2022, the Commission contends that the President of the General Court should:

–        dismiss the application for interim measures as unfounded;

–        order the applicant to pay the costs.

 Law

 General considerations

16      It is apparent from Articles 278 and 279 TFEU, read together with Article 256(1) TFEU, that the judge hearing an application for interim measures may, if he or she considers that the circumstances so require, order that the operation of a measure challenged before the Court be suspended or prescribe any necessary interim measures, pursuant to Article 156 of the Rules of Procedure. Nevertheless, Article 278 TFEU establishes the principle that actions do not have suspensory effect, since acts adopted by the institutions of the European Union are presumed to be lawful. It is therefore only exceptionally that the judge hearing an application for interim measures may order the suspension of operation of an act challenged before the Court or prescribe any interim measures (see order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12).

17      The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim measures must state ‘the subject matter of the proceedings, the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the interim measure applied for’.

18      The judge hearing an application for interim relief may thus order suspension of operation of an act and other interim measures, if it is established that such an order is justified, prima facie, in fact and in law, and that it is urgent in so far as, in order to avoid serious and irreparable harm to the applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, and consequently an application for interim measures must be dismissed if any one of them is not satisfied. The judge hearing an application for interim relief is also to undertake, when necessary, a weighing of the competing interests (see order of 2 March 2016, Evonik Degussa v Commission, C‑162/15 P-R, EU:C:2016:142, paragraph 21 and the case-law cited).

19      In the context of that overall examination, the judge hearing the application for interim measures enjoys a broad discretion and is free to determine, having regard to the particular circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (see order of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 23 and the case-law cited).

20      Having regard to the material in the case file, the President of the General Court considers that he has all the information needed to rule on the present application for interim measures without there being any need first to hear oral argument from the parties.

21      In the circumstances of the present case, it is appropriate to examine first whether the condition relating to urgency is satisfied.

 The condition relating to urgency

22      In order to determine whether the interim measures sought are urgent, it should be noted that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future final decision, in order to prevent a lacuna in the legal protection afforded by the EU Courts. To attain that objective, urgency must generally be assessed in the light of the need of an interlocutory order to avoid serious and irreparable damage to the party requesting the interim protection. That party must demonstrate that it cannot await the outcome of the main proceedings without suffering serious and irreparable damage (see order of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P-R, EU:C:2016:21, paragraph 27 and the case-law cited).

23      In addition, under the second sentence of Article 156(4) of the Rules of Procedure, applications for interim measures ‘shall contain all the evidence and offers of evidence available to justify the grant of interim measures’.

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

25      It is also settled case-law that, in order to determine whether all the conditions referred to in paragraph 22 above are fulfilled, the judge hearing the application for interim measures must have specific and precise information, supported by detailed, certified documentary evidence, which shows the situation in which the party seeking the interim measures finds itself and enables the probable consequences, should the measures sought not be granted, to be assessed. It follows that that party, in particular when it relies on the occurrence of financial damage, must produce, with supporting documentation, an accurate overall picture of its financial situation (see order of 29 February 2016, ICA Laboratories and Others v Commission, T‑732/15 R, not published, EU:T:2016:129, paragraph 39 and the case-law cited).

26      It is in the light of those criteria that it is necessary to examine whether the applicant has succeeded in demonstrating urgency.

27      In the present case, in the first place, in order to demonstrate the serious and irreparable nature of the harm suffered, the applicant submits that there will be no possibility of recovering the period of protection lost as a result of the market entry of the generic medicinal product at issue in the event that its appeal, or the appeals brought by the EMA or the Commission, against the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, under appeal, EU:T:2021:241), is upheld and the marketing authorisation for the generic medicinal product at issue is revoked on that basis. Furthermore, the applicant claims that the loss of the exclusive right to market an innovative product, price erosion and loss of market share throughout the European Union, which will occur during the period of the marketing protection infringement, will likely be irreversible and result in unquantifiable and non-recoverable damage. In addition, if the applicant is compelled to lower the price of its product as a result of the market entry of the generic medicinal product at issue, it will be impossible or very difficult for it to increase that price if it is successful in the appeal brought against the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, under appeal, EU:T:2021:241).

28      In the second place, the applicant claims that the placing on the market of the generic medicinal product at issue will have an impact not only on other products which it develops, in particular a new medicinal product, Vumerity, but will also affect the development and marketing of new treatments and its medical and educational support to patients suffering from multiple sclerosis.

29      In that regard, in the first place, the applicant’s argument that the loss of the exclusive right to market an innovative product, price erosion and loss of market share throughout the European Union will likely be irreversible and result in unquantifiable and non-recoverable damage relates to the impact of that loss on the applicant’s turnover from the reference medicinal product Tecfidera.

30      The applicant thus alleges damage which must be regarded as being purely financial, in that it consists in the loss of income likely to result from future sales of the reference medicinal product Tecfidera.

31      In that context, it should be noted that, where the harm referred to is of a financial nature, the interim measures sought are justified where it appears that, in the absence of those measures, the party seeking the measures would be in a position that would imperil its financial viability before final judgment is given in the main action, or where its market share would be affected substantially in the light of, inter alia, the size and turnover of its undertaking and, where appropriate, the characteristics of the group to which it belongs (see order of 12 June 2014, Commission v Rusal Armenal, C‑21/14 P-R, EU:C:2014:1749, paragraph 46 and the case-law cited). Since imminent disappearance from the market does constitute damage that is both irremediable and serious, adoption of the interim measure sought appears justified in such a situation (order of 9 June 2010, Colt Télécommunications France v Commission, T‑79/10 R, not published, EU:T:2010:228, paragraph 37).

32      Moreover, in accordance with settled case-law, damage of a pecuniary nature cannot, otherwise 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 obtained before that person suffered the damage. Any such damage could be recouped by the applicant’s bringing an action for compensation on the basis of Articles 268 and 340 TFEU (see order of 23 April 2015, Commission v Vanbreda Risk & Benefits, C‑35/15 P(R), EU:C:2015:275, paragraph 24 and the case-law cited).

33      While, in the case-law, account has also been taken of the fact that, if the measure sought were not granted, the applicant’s market share would be irremediably affected, it must be pointed out that this situation can be placed on an equal footing with that of the risk of disappearance from the market and justify adoption of the interim measure sought only if the irremediable effect on market share is also of a serious nature. It is therefore not sufficient that a market share may be irremediably lost by an undertaking; rather, it is necessary for that market share to be sufficiently large in the light of, in particular, the size of that undertaking, regard being had to the characteristics of the group to which it belongs through its shareholders. A party seeking interim measures which invokes the loss of such a market share must demonstrate, furthermore, that regaining a significant proportion of that share is impossible by reason of obstacles of a structural or legal nature (see order of 28 April 2009, United Phosphorus v Commission, T‑95/09 R, not published, EU:T:2009:124, paragraph 35 and the case-law cited).

34      It is in the light of those considerations that it is necessary to examine the evidence put forward by the applicant in order to establish that it would suffer serious and irreparable damage of a financial nature if the operation of the contested decision were not suspended.

35      In the present case, first, the applicant claims that that financial loss is not quantifiable or recoverable.

36      In that regard, it must be pointed out that, according to settled case-law, harm of a financial nature may be considered to be, inter alia, irreparable if the harm, even when it occurs, cannot be quantified (see order of 28 November 2013, EMA v InterMune UK and Others, C‑390/13 P(R), EU:C:2013:795, paragraph 49 and the case-law cited).

37      However, the uncertainty of obtaining compensation for pecuniary damage if an action for damages is brought cannot in itself be regarded as a factor capable of establishing that such damage is irreparable within the meaning of the case-law. At the interlocutory stage, the possibility of subsequently obtaining compensation for pecuniary damage if an action for damages is brought following annulment of the contested measure is necessarily uncertain. Interlocutory proceedings are not intended to act as a substitute for an action for damages in order to remove that uncertainty, since their purpose is only to guarantee the full effectiveness of the final future decision that will be made in the main action (in this case an action for annulment), to which the interlocutory proceedings are an adjunct (see order of 28 November 2013, EMA v InterMune UK and Others, C‑390/13 P(R), EU:C:2013:795, paragraph 50 and the case-law cited).

38      By contrast, the situation is different where it is already clear, when the assessment is carried out by the judge hearing the application for interim measures, that, in view of its nature and the manner in which it will foreseeably occur, the harm alleged, should it occur, may not be adequately identified or quantified and that, in practice, it will not therefore be possible to make good that harm by bringing an action for damages (see order of 28 November 2013, EMA v InterMune UK and Others, C‑390/13 P(R), EU:C:2013:795, paragraph 51 and the case-law cited).

39      In the present case, the applicant claims that the losses suffered will likely be irreversible and result in unquantifiable and non-recoverable damage. However, it is apparent from its pleadings that the damage allegedly suffered is identified and quantified, with the result that, in practice, it could be possible to make good the harm by bringing an action for damages, within the meaning of the case-law cited in paragraph 38 above. The applicant submits a certain amount of accounting information making it possible not only for that harm to be identified but also for it to be adequately quantified.

40      That information is, in particular, in paragraph 8 of Annex R.12 to the application for interim measures, by which the applicant provides quantitative evidence from which it may be concluded that the impact on its annual revenues of the market entry of generic copies of the reference medicinal product Tecfidera is estimated at [confidential] in 2022 and at [confidential] in 2023, as compared with a scenario with no market entry of generic medicinal products. Furthermore, the applicant confirms that that impact is estimated on the basis of the impact of analogous generic EU market entries and insights from the entry of the generic medicinal product Tecfidera in the United States.

41      Second, the applicant has not established, or even argued, that it is in a position that could imperil its financial viability before final judgment is given in the main action.

42      As is apparent from the applicant’s pleadings, in particular paragraph 4 of Annex R.13 to the application for interim measures, in 2021 the total global revenues of the parent company of the group to which the applicant belongs amounted to [confidential] and to [confidential] in the European Economic Area (EEA). The revenues from sales of the reference medicinal product Tecfidera in the EEA in 2021 represented an amount of [confidential], which corresponds to [confidential] of European turnover and [confidential] of global turnover.

43      It follows that, as the Commission states, in 2022 the expected loss of revenue of [confidential] referred to in paragraph 40 above represents only [confidential] of the annual revenue of the group to which the applicant belongs, which amounted to [confidential] in 2021. Furthermore, in 2023 the potential losses of [confidential] would represent only [confidential] of that annual revenue, assuming that the annual revenue of 2023 will be equivalent to the 2021 annual revenue.

44      In those circumstances, the loss of revenue which the applicant is likely to suffer does not appear to be such as to imperil its very existence.

45      For undertakings active on the highly regulated market of medicinal products for human use, the President of the Court of Justice found that, in the case of a loss corresponding to less than 10% of the turnover of the undertaking concerned, the financial difficulties that that undertaking might experience did not appear to be such as to imperil its very existence (see, to that effect, order of 11 April 2001, Commission v Bruno Farmaceutici and Others, C‑474/00 P(R), EU:C:2001:219, paragraph 106).

46      It follows from the foregoing that the damage alleged in the present case cannot be described as serious and irreparable in the light, in particular, of the applicant’s size and turnover and the characteristics of the group to which it belongs.

47      Third, as regards the alleged unquantifiable and non-recoverable damage caused by the irreversible loss of market share, first of all, it must be noted that the alleged loss of market share also constitutes damage of a purely financial nature in that it consists in the loss of revenue from the sales of Tecfidera.

48      According to settled case-law, the market share held by a company indicates only the percentage of all the products present on the market in question which were sold by that company to customers over the course of a specified reference period. Consequently, the loss of that market share consists in the loss of the profits liable to be realised in the future on sales of the product in question. A market share can thus clearly be represented in financial terms, as the holder of that market share can benefit from it only in so far as it generates profit for that holder (see order of 30 April 2010, Xeda International and Pace International v Commission, T‑71/10 R, not published, EU:T:2010:173, paragraph 41 and the case-law cited).

49      Next, it has been stated in paragraph 46 above that, in the light of the particular circumstances of the present case, the loss of expected revenue does not appear to be sufficiently extensive for the alleged harm to be regarded as being serious and irreparable.

50      Finally, the applicant has not demonstrated to the requisite legal standard the existence of obstacles of a structural or legal nature which prevent it from regaining a significant proportion of that market share, within the meaning of the case-law cited in paragraph 33 above.

51      It must be stated, as the Commission observes, that, in the event of annulment of the contested decision, the group to which the applicant belongs being the sole holder of a marketing authorisation for the reference medicinal product Tecfidera, its market share will automatically be recovered since no other undertaking will be authorised to place on the market that medicinal product or generic copies thereof.

52      It follows that, if the contested decision were annulled, the alleged loss of market share is clearly not irreversible and the applicant will be able to regain a significant proportion of that market share.

53      In the second place, as regards the applicant’s argument that the placing on the market of the generic medicinal product at issue will have an impact on other products which it develops, it should be noted that the damage alleged is also of a financial nature.

54      In that regard, it should be noted that the applicant does not provide the President of the Court with the essential material enabling the latter to examine the seriousness of the alleged impact on the other products which the applicant develops. The applicant merely makes general statements without specifying, for example, the estimated value of those costs.

55      Nevertheless, it must be stated that, in accordance with the case-law referred to in paragraphs 23 to 25 above, it is for the applicant to put the defendant and the judge hearing the application for interim measures in a position to assess the seriousness of the damage by providing them with specific and precise information.

56      Thus, the applicant does not provide any information making it possible to assess the seriousness of the alleged damage owing to the impact which the marketing of the generic medicinal product at issue will have on other products which it develops.

57      Lastly, it is apparent from the applicant’s pleadings, in particular paragraph 23 et seq. of Annex R.12 to the application for interim measures, that the expected loss of revenue will affect the development and marketing of new treatments and its support for patients suffering from multiple sclerosis, in so far as the applicant will be compelled to reduce its investment in research and development and medical and educational support for patients suffering from multiple sclerosis.

58      In that regard, it must be stated that the decision to reduce investment in research and development and medical and educational support for patients suffering from multiple sclerosis is not necessarily a direct consequence of the contested decision, but could result from an independent decision of the applicant based on considerations of profitability.

59      According to established case-law, when suspension of the operation of a European Union act is sought, the grant of the interim measure requested is justified only where the act at issue constitutes the decisive cause of the alleged serious and irreparable damage (see order of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P-R, EU:C:2016:21, paragraph 45 and the case-law cited).

60      In those circumstances, it must be concluded that the present application for interim measures does not satisfy the condition relating to urgency.

61      Since the conditions for granting suspension of operation and interim measures are cumulative, it follows from all of the foregoing that the application for interim measures must be dismissed, without it being necessary to rule on whether there is a prima facie case, or even to weigh up the interests involved.

62      In accordance with Article 158(5) of the Rules of Procedure, it is appropriate to reserve the costs.

On those grounds,

THE PRESIDENT OF THE GENERAL COURT

hereby orders:

1.      The application for interim measures is dismissed.

2.      The costs are reserved.

Luxembourg, 4 August 2022.

*      Language of the case: English.

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