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‑278/23 R,

Zentiva Pharma GmbH,

represented by K. Roox, T. De Meese and J. Stuyck, lawyers,

applicants,

European Commission,

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

defendant,

makes the following

1By their application based on Articles 278 and 279 TFEU, the applicants, Zentiva k.s. and Zentiva Pharma GmbH, seek, 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 them, and, second, an injunction requiring the European Commission to refrain from taking any other measures which would amount to a withdrawal of the MAs enjoyed by them or a prohibition on placing generic Dimethyl fumarate (‘DMF’) products on the market.

Background to the case and forms of order sought

2The applicants are pharmaceutical companies belonging to the Zentiva group which develop and market medicinal products. They hold several MAs for a generic DMF medicinal product, indicated for the treatment of multiple sclerosis. Those MAs were obtained through the decentralised MA procedure in many countries, with Tecfidera as the reference product. Zentiva is the actual beneficiary of the income generated by the sale of those products.

3On 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.

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.

10On 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.

11On 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.

12Biogen brought an action for annulment of that decision. That action is currently pending before the Court (Case T‑268/22).

13Following the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), the applicants obtained several national MAs for their generic DMF medicinal products with Tecfidera as a reference medicinal product under the decentralised procedure laid down by Directive 2001/83.

14In particular, on 5 September 2022, Zentiva Pharma obtained a national MA with Germany as the reference Member State.

15Immediately after obtaining that MA, the applicants began to launch their generic DMF medicinal products in Germany.

16By 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.

17On 2 May 2023, the Commission adopted the contested decision, by which it amended the implementing decision of 30 January 2014, granting Biogen an additional year of marketing protection for Tecfidera, until 2 February 2025, with retroactive effect from 16 March 2023.

18By application lodged at the Court Registry on 23 May 2023, the applicants 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 them.

19By separate document, lodged at the Court Registry on the same date, the applicants brought the present application for interim measures, in which they claim 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 applicants, 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 applicants, 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 applicants’ MAs or prohibiting the applicants from placing generic DMF products on the market;

–order any other interim measure it considers appropriate;

–order the Commission to pay the costs.

20In its observations on the application for interim measures, which were lodged at the Court Registry on 8 June 2023, the Commission contends that the President of the General Court should:

–dismiss the application for interim measures;

–order the applicants to pay the costs.

21By 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.

22On 20 June 2023, the main parties submitted their observations on that application.

23By document lodged at the Court Registry on 20 June 2023, the applicants 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

24It 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).

25The 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’.

26The 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).

27In 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).

28Having 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.

29In 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

30In 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).

31It is in the light of those criteria that it is necessary to examine whether the applicants have succeeded in demonstrating urgency.

32In the present case, the applicants submit that they will suffer serious and irreparable damage if operation of the contested decision is not suspended.

33In their submission, the contested decision has the effect of prohibiting them from using their MAs until 2 February 2025, which has immediate consequences for them and for third parties. In that regard, they submit, inter alia, that they would suffer damage consisting of, first, a loss of profit for the period during which they 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 generic DMF products after the new period of protection for placing on the market; and, fourth, damage to their reputations.

34Next, the applicants submit facts which occurred after the adoption of the contested decision and further illustrate the situation in which they find themselves. Thus, first, they submit that Zentiva Pharma’s German national MA was suspended by the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Medicinal Products and Medical Devices, Germany) in opposition proceedings brought by Biogen. Second, they maintain that, on 10 May 2023, Biogen sent them a letter in which it asked the applicants to stop placing their products on the market until the expiry of the marketing protection which Biogen enjoyed and, moreover, informed the applicants of its intention to claim damages if the applicants failed to comply with the contested decision. Third, the applicants submit that it is plausible that Biogen will try to obtain prompt interim measures before national courts by referring to the contested decision. Fourth, they argue that some national authorities are putting pressure on the applicants to comply with the Commission’s position and are threatening to impose penalties if they refuse.

35The Commission disputes the applicants’ arguments.

36First, 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 applicants’ MAs.

37Second, as regards the applicants’ argument that Biogen and national authorities have taken certain measures against them 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.

38In that regard, it should be pointed out that, if the applicants were in fact ordered in the future to pay damages to Biogen, the applicants 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 applicants would be clearly identified in the relevant judgment and would therefore be quantifiable; accordingly, it cannot be regarded as irreparable.

39Moreover, as regards the alleged suspension of Zentiva Pharma’s German national MA, it should be noted that it is in the context of a possible action against that decision before the competent authorities and courts that it is necessary to assess whether that applicant’s arguments are sufficient to order that it be varied or suspended.

40Accordingly, the applicants have not succeeded in demonstrating that they would suffer serious and irreparable damage if the suspension of operation of the contested decision were not granted.

41It follows from all of the foregoing that the application for interim measures must be dismissed since the applicants have 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

42Since the present order dismisses the application for interim measures submitted by the applicants, 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 applicants (see paragraphs 21 and 23 above).

Costs

43Under Article 158(5) of the Rules of Procedure, the costs incurred by the applicants and by the Commission in relation to the proceedings for interim relief are to be reserved.

44In 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 Zentiva k.s. and Zentiva Pharma GmbH.

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

—

Language of the case: English.