24 July 2023 (*)

(Interim relief – Medicinal products for human use – Marketing authorisation – Application for interim measures – Application for injunction – Lack of urgency)

In Case T‑256/23 R,

Mylan Ireland Ltd,

established in Dublin (Ireland), represented by K. Roox, T. De Meese, J. Stuyck and C. Dumont, lawyers,

applicant,

European Commission,

represented by E. Mathieu, L. Haasbeek and A. Spina, acting as Agents,

defendant,

makes the following

2By its application based on Articles 278 and 279 TFEU, the applicant, Mylan Ireland Ltd, seeks, in essence, first, 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 (‘MA’) for the medicinal product for human use Tecfidera – Dimethyl fumarate (‘Tecfidera’) 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 (‘the contested decision’), and any subsequent decision or act extending or replacing the contested decision 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 MA enjoyed by it or a prohibition on placing generic Dimethyl fumarate products on the market.

Background to the case and forms of order sought

3The applicant is a pharmaceutical company which develops and markets medicinal products, including the generic medicinal product for human use Dimethyl fumarate Mylan – dimethyl fumarate (‘DMF Mylan’), indicated for the treatment of multiple sclerosis.

5On 28 February 2012, Biogen Idec Ltd submitted to the European Medicines Agency (EMA), pursuant to Article 4(1) of Regulation No 726/2004, an application for MA for the medicinal product Tecfidera.

7On 30 January 2014, the Commission adopted Implementing Decision C(2014) 601 final granting marketing authorisation under Regulation No 726/2004 for ‘Tecfidera’ (‘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).

9On 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 Tecfidera.

11By decision of 30 July 2018, the EMA informed Pharmaceutical Works Polpharma that it was unable to validate its application for the grant of an MA to place on the market a generic medicinal product derived from Tecfidera, on the ground that, in essence, according to recital 3 of the implementing decision of 30 January 2014, Tecfidera, on the one hand, and the already authorised medicinal product Fumaderm, on the other, did not belong to the same global marketing authorisation as described in Article 6(1) of Directive 2001/83, and that, consequently, since Tecfidera benefits from an independent eight-year period of data protection, that protection period had not yet expired (‘the EMA decision of 30 July 2018’).

127

13By application lodged at the Registry of the General Court on 9 October 2018 and registered as Case T‑611/18, Pharmaceutical Works Polpharma brought an action seeking annulment of the EMA decision of 30 July 2018 and put forward a plea of illegality under Article 277 TFEU in respect of the implementing decision of 30 January 2014 in so far as, in that implementing decision, the Commission considered that Tecfidera was not covered by the same global marketing authorisation as Fumaderm.

148

15By judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), the General Court upheld the plea of illegality raised by Pharmaceutical Works Polpharma and annulled the EMA decision of 30 July 2018.

169

17The judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), was the subject of three appeals brought by the Commission, Biogen Netherlands BV (‘Biogen’) and the EMA.

1810

19On 2 June 2021, Biogen submitted to the Commission an application for a new therapeutic indication and for a one-year extension of marketing protection for Tecfidera in accordance with Article 14(11) of Regulation No 726/2004.

2011

21On 13 May 2022, by Commission Implementing Decision C(2022) 3251 final amending the implementing decision of 30 January 2014, the Commission rejected Biogen’s application for an extension.

2212

23Biogen brought an action for annulment of that decision. That action is currently pending before the Court (Case T‑268/22).

2413

25Following the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), the applicant submitted an application for an MA for a generic version of Tecfidera.

2614

27On 13 May 2022, the Commission granted an MA to the applicant for DMF Mylan by Implementing Decision C(2022) 3252 final granting marketing authorisation under Regulation No 726/2004 for DMF Mylan as a medicinal product for human use.

2815

29Biogen brought an action for annulment of that decision. That action is currently pending before the Court (Case T‑279/22).

3016

31After obtaining the MA, as from 2022, the applicant began to launch the medicinal product DMF Mylan in various Member States of the European Union.

3217

33By judgment of 16 March 2023, Pharmaceutical Works Polpharma v EMA (C‑438/21 P to C‑440/21 P, EU:C:2023:213), the Court of Justice set aside the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241). Ruling subsequently on the action at first instance, the Court of Justice rejected the single plea in law alleging illegality of the implementing decision of 30 January 2014 and, therefore, dismissed the action.

3418

35By letter of 17 March 2023, the Commission’s Directorate-General (DG) for Health and Food Safety requested the applicant to comply with the market protection period for Tecfidera for the placing on the market of DMF Mylan and to give written undertakings to that effect by 30 March 2023 at the latest. In addition, the Commission informed the applicant that it reserved the right to take any other decision as to any follow-up regulatory actions that might be taken on the basis of the judgment of 16 March 2023, Pharmaceutical Works Polpharma v EMA (C‑438/21 P to C‑440/21 P, EU:C:2023:213).

3619

37By application lodged at the Court Registry on 2 May 2023, the applicant brought an action for annulment of the Commission decision which, according to the applicant, is contained in its letter of 17 March 2023, and an application for interim measures. That action is currently pending before the Court (Case T‑227/23).

39On 2 May 2023, the Commission adopted the contested decision, by which it amended the implementing decision of 30 January 2014 by granting Biogen an additional year of marketing protection for Tecfidera, until 2 February 2025, with retroactive effect from 16 March 2023.

4021

41By application lodged at the Court Registry on 15 May 2023, the applicant brought an action for annulment of the contested decision, and of any other subsequent decision or measure extending or replacing the contested decision, in so far as they concerned it.

4222

43By separate document, lodged at the Court Registry on the same date, the applicant brought the present application for interim measures, in which it claims that the President of the General Court should:

–order the suspension of operation of the contested decision, as well as of any other subsequent decision or measure extending or replacing the contested decision, in so far as they concern the applicant, with immediate effect in accordance with Article 157(2) of the Rules of Procedure of the General Court;

–order the suspension of operation of the contested decision, as well as of any other subsequent decision or measure extending or replacing the contested decision, in so far as they concern the applicant, pending the Court’s ruling on the main action;

–order the Commission to refrain from taking any other measure which would amount to withdrawing the applicant’s MA or prohibiting the applicant from placing generic Dimethyl fumarate products on the market;

–order any other interim measure it considers appropriate;

–order the Commission to pay the costs.

45In its observations on the application for interim measures, which were lodged at the Court Registry on 7 June 2023, the Commission contends that the President of the General Court should:

–dismiss the application for interim measures;

–order the applicant to pay the costs.

47By document lodged at the Court Registry on 9 June 2023, Biogen applied for leave to intervene in support of the form of order sought by the Commission.

49On 20 June 2023, the main parties submitted their observations on that application.

5026

51By document lodged at the Court Registry on 20 June 2023, the applicant submitted an application for confidential treatment, vis-à-vis Biogen, of certain information contained in the application for interim measures and in the Commission’s observations.

Law

General considerations

5227

53It 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 (order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12).

5428

55The 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’.

5629

57The 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).

5830

59In 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).

6031

61Having 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.

6232

63In 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

6433

65In 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).

6634

67It is in the light of those criteria that it is necessary to examine whether the applicant has succeeded in demonstrating urgency.

6835

69In the present case, the applicant submits that it will suffer serious and irreparable damage if operation of the contested decision is not suspended.

7036

71In its submission, the contested decision has the effect of prohibiting it from using its MA until 2 February 2025, which has immediate consequences for it and for third parties. In that regard, it submits, inter alia, that it would suffer damage consisting of, first, a loss of profit for the period during which it should have been on the market; second, the total loss of market share; third, the costs associated with the new placing on the market of DMF Mylan after the new period of protection for placing on the market; and, fourth, damage to its reputation.

7237

73Next, the applicant submits facts which occurred after the adoption of the contested decision and further illustrate the situation in which it finds itself. Thus, first, it maintains that, on 4 May 2023, Biogen sent it a letter in which it asked the applicant to stop placing its products on the market until the expiry of the marketing protection which Biogen enjoyed and, moreover, informed the applicant of its intention to claim damages if the applicant failed to comply with the contested decision. Second, the applicant submits that it is plausible that Biogen will try to obtain prompt interim measures before national courts by referring to the contested decision. Third, it argues that some national authorities are putting pressure on the applicant to comply with the Commission’s position and are threatening to impose penalties if it refuses. Fourth, according to the applicant, the Commission announced that it was going to adopt a decision amending the applicant’s MA in order to specify that the marketing protection for Tecfidera had to be respected.

7438

75The Commission disputes the applicant’s arguments.

7639

77First, it should be noted that the contested decision, by which the Commission granted Biogen an additional year of marketing protection for Tecfidera, is addressed to that undertaking and, as such, has no effect on the legality of the applicant’s MA.

7840

79Second, as regards the applicant’s argument that Biogen and national authorities have taken certain measures against it in reliance on the contested decision, it must be stated that that argument relates to current or future conduct of third parties invoking the contested decision. Such conduct is attributable to those third parties and does not stem from the contested decision.

42In that regard, it should be pointed out that, if the applicant were in fact ordered in the future to pay damages to Biogen, the applicant would suffer damage of a financial nature. However, purely pecuniary damage cannot in principle be regarded as irreparable or even as difficult to repair, since it may be the subject of subsequent financial compensation. In the present case, it must be stated that the potential damage relied on in this respect by the applicant would be clearly identified in the relevant judgment and would therefore be quantifiable; accordingly, it cannot be regarded as irreparable.

43Moreover, as regards the intention of the Commission to vary the applicant’s MA, it should be noted that the mere manifestation on the part of the Commission of an intention to adopt a specific decision in the future is not capable of producing binding legal effects that directly and immediately affect the applicant’s interests (see, to that effect, judgment of 8 October 2014, Bermejo Garde v EESC, T‑530/12 P, EU:T:2014:860, paragraphs 45 to 48). The Commission’s announcement of that intention does not therefore create corresponding obligations on the part of the applicant and, in the present case, such an intention is not sufficient to demonstrate urgency in relation to the contested decision. In that regard, should the applicant’s MA be varied or withdrawn, it is in the context of any action against such a decision and any corresponding application for interim measures that it would be necessary to assess whether the arguments put forward by the applicant to demonstrate urgency would be sufficient for the purposes of ordering suspension of operation.

44Thus, as regards the third head of claim, by which the applicant seeks an order requiring the Commission to refrain from taking any other measure which would amount to a withdrawal of its MA or a prohibition on placing DMF Mylan on the market, suffice it to observe that the applicant will have the opportunity to challenge such measures by bringing an action for annulment when the Commission has actually taken decisions to that effect.

45Accordingly, the applicant has not succeeded in demonstrating that it would suffer serious and irreparable damage if the suspension of operation of the contested decision were not granted.

46It follows from all of the foregoing that the application for interim measures must be dismissed since the applicant has failed to establish that the condition relating to urgency is satisfied, without it being necessary to rule further on the admissibility of the present application for interim measures, to examine whether there is a prima facie case or to weigh up the interests involved.

The application to intervene

47Since the present order dismisses the application for interim measures submitted by the applicant, there is no longer any need, in the interests of procedural efficiency, to rule on Biogen’s application to intervene in support of the form of order sought by the Commission or on the application for confidential treatment of certain information submitted by the applicant (see paragraphs 24 and 26 above).

Costs

48Under Article 158(5) of the Rules of Procedure, the costs incurred by the applicant and by the Commission in relation to the proceedings for interim relief are to be reserved.

49In the circumstances of the present case, pursuant to Article 144(10) of the Rules of Procedure, each party is to bear its own costs relating to the application to intervene.

On those grounds,

hereby orders:

1.The application for interim measures is dismissed.

2.There is no longer any need to rule on the application to intervene submitted by Biogen Netherlands BV or on the application for confidential treatment submitted by Mylan Ireland Ltd.

3.The costs relating to the proceedings for interim relief are reserved.

4.Each party shall bear its own costs relating to the application to intervene submitted by Biogen Netherlands.

Luxembourg, 24 July 2023.

Registrar

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Language of the case: English.