19 July 2023 (*)

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

In Case T‑226/23 R,

Neuraxpharm Pharmaceuticals, SL,

established in Barcelona (Spain), represented by K. Roox, T. De Meese, J. Stuyck, M. Van Nieuwenborgh and C. Dumont, lawyers,

applicant,

European Commission,

represented by E. Mathieu and C. Valero, acting as Agents,

defendant,

makes the following

1By its application based on Articles 278 and 279 TFEU, the applicant, Neuraxpharm Pharmaceuticals, SL, seeks, in essence, first, suspension of operation of the decision of the European Commission contained in its letter of 17 March 2023, by which the Commission requires it to comply with the protection period for the reference medicinal product Tecfidera – Dimethyl fumarate (‘Tecfidera’) as regards the placing on the market of the medicinal product Dimethyl fumarate Neuraxpharm – Dimethyl fumarate (‘DMF Neuraxpharm’) and to give written undertakings to that effect (‘the contested measure’) and any subsequent decision or act extending or replacing the contested measure, 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 marketing authorisation (‘MA’) enjoyed by it or a prohibition on placing DMF Neuraxpharm on the market.

Background to the case and forms of order sought

2The applicant is a pharmaceutical company which develops and markets medicinal products, including the generic medicinal product for human use DMF Neuraxpharm, indicated for the treatment of multiple sclerosis.

3On 28 February 2012, Biogen Idec Ltd submitted to the European Medicines Agency (EMA), 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), as amended, an application for MA for the medicinal product Tecfidera.

4On 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).

5On 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.

6By 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’).

7By 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.

8By 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.

9The 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.

10Following 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.

11On 13 May 2022, the Commission granted an MA to the applicant for DMF Neuraxpharm by Implementing Decision C (2022) 3254 final granting marketing authorisation under Regulation No 726/2004 for DMF Neuraxpharm as a medicinal product for human use.

12By application lodged at the Court Registry on 17 May 2022, Biogen brought an action for annulment of the applicant’s MA. That action is currently pending before the Court (Case T‑278/22).

13After obtaining the MA as from 2022, the applicant began to launch the medicinal product DMF Neuraxpharm in various Member States of the European Union.

14By 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 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.

15By 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 Neuraxpharm 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, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213).

16By application lodged at the Court Registry on 2 May 2023, the applicant brought an action for annulment of the contested measure and of any other subsequent decision or measure extending or replacing the contested measure, in so far as they concerned it.

17By 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 measure, as well as of any other subsequent decision or measure extending or replacing the contested measure, 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 measure, as well as of any other subsequent decision or measure extending or replacing the contested measure, 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 DMF Neuraxpharm on the market;

–order any other interim measure it considers appropriate;

–order the Commission to pay the costs.

18On 11 May 2023, the applicant lodged at the Court Registry, inter alia, first, Commission Implementing Decision C(2014) 601 (final) of 2 May 2023, by which the Commission annulled and replaced its Decision C(2022) 3251 (final) of 13 May 2022, granting Biogen a further year of marketing protection for Tecfidera, until February 2025, and, second, a draft Commission decision amending the MA decision granted to it on 13 May 2022 by adding a condition that DMF Neuraxpharm should not be placed on the market before the expiry of the marketing protection for Tecfidera.

19In its observations on the application for interim measures, which were lodged at the Court Registry on 30 May 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.

Law

General considerations

20It 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).

21The 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’.

22The 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).

23In 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).

24Having 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.

25In the circumstances of the present case and without prejudice to the determination of admissibility of the main action lodged by the applicant, it is appropriate to examine first whether the condition relating to urgency is satisfied.

The condition relating to urgency

26In 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).

27It is in the light of those criteria that it is necessary to examine whether the applicant has succeeded in demonstrating urgency.

28In the present case, the applicant submits that it will suffer serious and irreparable damage if operation of the contested measure is not suspended.

29In its submission, the contested measure has the effect of prohibiting it from using its MA, 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 Neuraxpharm after the new period of protection for placing on the market; and, fourth, damage to its reputation.

30In addition, the applicant submits that the Commission informed it of its intention, first, to grant Biogen an extension of the marketing protection for Tecfidera and, second, to amend the MA granted to it for DMF Neuraxpharm in order to include a condition that no product may be placed on the market under the MA before the expiry of Biogen’s data protection period.

31The Commission disputes the applicant’s arguments.

32First, it should be noted that the applicant seeks suspension of operation of the letter of the Commission’s DG for Health and Food Safety, signed by a head of unit of that DG, in which the Commission gives its interpretation of 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), and by which it requests the applicant to comply with the period of protection for the placing on the market of Tecfidera and requiring it to give a written undertaking to that effect. The letter states at the end that the Commission reserves the right to take regulatory action to ensure compliance with that judgment.

33In making such a request, the Commission may at most seek some clarification of the legal situation on the market concerned for the medicinal products.

34Moreover, that letter does not refer to the MA granted to the applicant. It should be noted in that regard that Article 81 of Regulation No 726/2004 provides that any decision to vary or revoke an MA must state in detail the reasons on which it is based and that such a decision may be taken only in accordance with the procedures laid down in that regulation. In particular, under Article 10(1) of Regulation No 726/2004, the Commission is required to prepare a draft of the decision to be taken and to forward that draft to the Member States and the applicant. Furthermore, although the Commission states in the contested measure that it reserves the right to take any other decision on any follow-up regulatory measures to be taken following 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), it is not apparent either from the wording or from the content of that measure that the Commission intended simply thereby to initiate the procedure for the variation or withdrawal of the applicant’s MA. Accordingly, the contested measure cannot in any way be regarded as a decision amending or revoking that MA.

Second, as regards the measures which the Commission took after the adoption of the contested measure or which it still might intend to take, it must be observed that they cannot be taken into consideration in the present case, which is linked to an action for annulment of that measure, the legality of which must be assessed on the basis of the elements of fact and of law available to the Commission at the time when the measure was adopted.

37Thus, the Commission’s decision to grant Biogen an additional year of marketing protection for Tecfidera, until February 2025, is the subject of the application for interim measures brought by the applicant in Case T‑257/23 R.

38As 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 Neuraxpharm 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.

39Consequently, the applicant has not succeeded in demonstrating that it would suffer serious and irreparable damage if suspension of operation of the contested measure were not granted.

40It 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.

Under Article 158(5) of the Rules of Procedure, the costs are to be reserved.

On those grounds,

hereby orders:

1.The application for interim measures is dismissed.

2.The costs are reserved.

Luxembourg, 19 July 2023.

Registrar

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Language of the case: English.