ratiopharm and Others v Orion and Commission (Appeal - Medicinal products for human use - dexmedetomidine - Order) [2021] EUECJ C-220/21P(I)

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(Appeal – Intervention – Second paragraph of Article 40 of the Statute of the Court of Justice of the European Union – Interest in the result of the case – Public health – Medicinal products for human use – Regulation (EC) No 726/2004 – Directive 2001/83/EC – Decision granting marketing authorisation for the medicinal product for human use Dexmedetomidine Accord – dexmedetomidine – Dismissal)

APPEAL under the first paragraph of Article 57 of the Statute of the Court of Justice of the European Union, brought on 6 April 2021,

Teva Pharma – Produtos Farmaceuticos Lda, established in Porto Salvo (Portugal),

Orion Oyj, established in Espoo (Finland), represented by C. Schoonderbeek, advocaat, and by J. Mulryne and E. Amos, Solicitors,

European Commission, represented by L. Haasbeek and R. Lindenthal, acting as Agents,

1 By their appeal, ratiopharm GmbH, Teva Pharma – Produtos Farmaceuticos Lda, Teva Danmark A/S, Teva Sweden AB and Teva Nederland BV (‘Teva and Others’) seek a declaration from the Court of Justice that an error in law was made by the President of the Eighth Chamber of the General Court of the European Union in his order of 5 March 2021, Orion v Commission (T‑223/20, not published, EU:T:2021:137; ‘the order under appeal’), by which the latter dismissed their application to intervene in support of the European Commission – the defendant at first instance – in Case T‑223/20, concerning the action brought on 23 April 2020 by Orion Oyj seeking the annulment of Commission Implementing Decision C(2020) 942 (final) of 13 February 2020 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Dexmedetomidine Accord – dexmedetomidine’, a medicinal product for human use (‘the decision at issue’).

2 In addition, Teva and Others request that the Court grant their application to intervene in Case T‑223/20, in accordance with the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union.

3 Orion and the Commission submitted their written observations regarding the appeal on 28 April 2021.

4 By the order under appeal, the General Court dismissed the application to intervene submitted by Teva and Others in support of the form of order sought by the Commission in Case T‑223/20.

5 In the first place, the General Court set out the background to the dispute in paragraphs 1 to 7 of that order. It stated that, by the decision at issue, the Commission had granted the company Accord Healthcare SLU (‘Accord’) a marketing authorisation for the medicinal product named Dexmedetomidine Accord – dexmedetomidine (‘Dexmedetomidine Accord’), the application for which had been lodged on 28 December 2018. It noted that that application was based not only on the reference medicinal product Dexdor, the active substance of which is dexmedetomidine, but also on the medicinal product Precedex, the active substance of which is also dexmedetomidine, and for which a marketing authorisation had been granted to Orion and its licensees in the Czech Republic in 2002. It stated that Dexmedetomidine Accord is a generic medicinal product, within the meaning of Article 10(2) 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), of the reference medicinal products Dexdor and Precedex.

6 The General Court explained that the marketing authorisation for Dexmedetomidine Accord had been granted on the ground that Dexdor and Precedex belonged to the same global marketing authorisation for the purposes of Article 6(1) of Directive 2001/83. It followed that the regulatory data protection period for Precedex had been regarded as having expired when Accord lodged its marketing authorisation application for Dexmedetomidine Accord. Furthermore, since Dexdor belonged to the same global marketing authorisation as Precedex, it did not benefit from its own independent regulatory data protection period.

7 The General Court went on to state that, in accordance with Article 10(1) in conjunction with Article 10(2)(a) of Directive 2001/83, it was considered that Accord could rely on pre-clinical and clinical data submitted in support of the marketing authorisation application for Dexdor in order to obtain a marketing authorisation for the generic medicinal product Dexmedetomidine Accord.

8 Furthermore, the General Court noted that, in Case T‑223/20, Orion seeks the annulment of the decision at issue on the ground that the marketing authorisation for Precedex had not been granted in accordance with the relevant provisions of EU law applicable at the material time, with the result that that medicinal product should not have been regarded as a valid reference medicinal product for the purpose of obtaining a marketing authorisation concerning a generic medicinal product.

9 In the second place, in paragraphs 13 to 31 of the order under appeal, the General Court examined the application to intervene submitted by Teva and Others. After finding, in paragraphs 23 and 24 of that order, that Accord was the sole addressee of the decision at issue and that that decision was applicable only to the product characteristics summarised in Annex I to that decision, it concluded from this, in paragraphs 25 and 26 of that order, that the dismissal of the action brought by Orion or the annulment of the decision at issue would in no way alter the legal position of Teva and Others.

10 Moreover, in paragraphs 27 and 28 of the order under appeal, the General Court rejected Teva and Others’ argument that, if the application to intervene were to be rejected by the General Court, they would not be in a position to submit their observations regarding the issues of interpretation of EU law raised in connection with the action in Case T‑223/20. In that regard, the General Court noted, inter alia, that Teva and Others are interveners in support of the Lægemiddelstyrelsen (Medicines Agency, Denmark) in the case brought before the Københavns byret (Copenhagen District Court, Denmark), which has now given rise to a request for a preliminary ruling submitted to the Court of Justice by that court concerning the same issues of EU law as those raised in Case T‑223/20. It pointed out that Teva and Others, as interveners in national proceedings which have given rise to a request for a preliminary ruling, are entitled, under the first and second paragraphs of Article 23 of the Statute of the Court of Justice of the European Union, to submit statements of case or written observations to the Court.

11 Lastly, in paragraphs 29 to 31 of the order under appeal, the General Court found that Teva and Others did not have an interest in the result of the case within the meaning of the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union and rejected their application to intervene.

12 In support of their appeal, Teva and Others claim, in the first place, that they have a direct and specific interest in the result of the case which justifies their intervention in support of the form of order sought by the Commission. Consequently, the General Court erred in law in paragraph 30 of the order under appeal by finding that they were not directly affected by the outcome of the case before it.

13 In that regard, Teva and Others note that there is an explicit link between the action for annulment brought by Orion before the General Court, the request for a preliminary ruling submitted by the Københavns byret (Copenhagen District Court), and the various national proceedings brought by Orion. That company relied on the same arguments before those courts in order to challenge the validity of the marketing authorisation granted to Accord.

14 Since the marketing authorisations granted to the applicants for leave to intervene for the generic dexmedetomidine medicinal products are based, in essence, on the same legal basis as the marketing authorisation granted to Accord and contested by Orion, Teva and Others argue that they should be able to intervene in the present proceedings in order to guarantee their right to a defence.

15 Furthermore, they claim that, while it is true that the General Court should stay the proceedings relating to Orion’s action for annulment until the Court of Justice has delivered its judgment on the request for a preliminary ruling submitted by the Københavns byret (Copenhagen District Court) given that the two sets of proceedings concern the same legal issues, it is not certain that the General Court will do so. Thus, according to Teva and Others, the General Court could rule on issues which, in essence, would directly affect the marketing authorisation of Teva and Others in Denmark.

16 In the second place, Teva and Others seek the rectification, pursuant to Article 164 of the Rules of Procedure of the General Court, of a material error allegedly made by that court in paragraph 28 of the order under appeal. In that paragraph, the General Court stated that, ‘in [the] view [of the applicants for leave to intervene]’, the case before the Københavns byret (Copenhagen District Court) should give rise to a request for a preliminary ruling, whereas Teva and Others disagree with the decision of that Danish court to make such a request for a preliminary ruling, having regard to the judgment of 14 March 2018, Astellas Pharma (C‑557/16, EU:C:2018:181).

17 Under the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union, any person may intervene before the Courts of the European Union if that person can establish an interest in the result of a case submitted to one of those Courts.

18 It is settled case-law that the concept of ‘an interest in the result of the case’, within the meaning of that provision, must be defined in the light of the precise subject matter of the case and be understood as meaning a direct and existing interest in the ruling on the forms of order sought and not as an interest in relation to the pleas in law or arguments put forward. The term ‘the result of the case’ refers to the final decision sought, as set out in the operative part of the future judgment (order of the Vice-President of the Court of 13 November 2019, EDP España v Commission, C‑536/19 P(I), not published, EU:C:2019:965, paragraph 29 and the case-law cited).

19 In that regard, it is necessary in particular to verify that the applicant for leave to intervene is directly affected by the contested act and that its interest in the result of the case is certain. In principle, an interest in the result of the case can be considered to be sufficiently direct only to the extent that that result is likely to alter the legal position of the applicant for leave to intervene (order of the Vice-President of the Court of 13 November 2019, EDP España v Commission, C‑536/19 P(I), not published, EU:C:2019:965, paragraph 30 and the case-law cited).

20 Furthermore, it is necessary to distinguish between applicants for leave to intervene who can establish a direct interest in the ruling on the forms of order sought by the parties to the dispute in which they wish to intervene and those who can establish only an indirect interest in the result of the case by reason of similarities between their situation and that of one of the parties (order of the President of the Court of 16 July 2020, NRW. Bank v SRB, C‑662/19 P, not published, EU:C:2020:607, paragraph 11 and the case-law cited).

21 In the present case, it should be noted that, by the arguments summarised in paragraphs 12 to 15 of the present order, Teva and Others merely claim, in general terms, that they should be allowed to intervene because of the similarities between their situation and that of Accord, inasmuch as those companies hold marketing authorisations for generic dexmedetomidine medicinal products.

22 Furthermore, as the General Court rightly noted in paragraphs 23 to 25 of the order under appeal, which are not contested by Teva and Others in their appeal, it should be borne in mind that Accord is the sole addressee of the decision at issue, that none of the applicants for leave to intervene is mentioned in that decision, and that the decision at issue is applicable only to the product characteristics which are summarised in Annex I thereto.

23 In those circumstances, regardless of whether the General Court upholds or dismisses the action brought by Orion in Case T‑223/20, the result of the case, as set out in the operative part of the future judgment or order, will not, as such, be likely to alter the legal position of Teva and Others.

24 It follows that the General Court was fully entitled to find that Teva and Others could not establish a direct and existing interest in the result of the case within the meaning of the case-law referred to in paragraphs 18 to 20 of the present order.

25 In any event, it should be noted that, in their appeal, Teva and Others do not expressly seek to have the order under appeal set aside, but claim that, because of the error of law made by the General Court in its interpretation and application of the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union, they should be allowed to intervene in the proceedings before the General Court. However, under Article 169(1) of the Rules of Procedure of the Court of Justice, an appeal must seek to have set aside, in whole or in part, the decision of the General Court as set out in the operative part of that decision. Therefore, the form of order whereby Teva and Others seek a declaration from the Court of Justice that an error of law was made by the General Court in the order under appeal is manifestly inadmissible, given that it does not seek to have that order set aside.

26 As regards the application for rectification of the order under appeal submitted by those companies, it is sufficient to note that, on the same grounds as those set out in the preceding paragraph, it is inadmissible. In addition, it must be pointed out that, pursuant to Article 164(1) and (2) of the Rules of Procedure of the General Court, the General Court may rectify clerical mistakes, errors in calculation and obvious inaccuracies on application by a party; that application is to be made within two weeks after delivery of the judgment or service of the order.

27 Since Teva and Others have made their application for rectification of the order under appeal to the Court of Justice, their application for rectification cannot be granted in any event.

29 Under Article 184(2) of the Rules of Procedure of the Court of Justice, where the appeal is unfounded, the Court is to make a decision as to costs. Under Article 138(1) of those rules, applicable to appeal proceedings by virtue of Article 184(1) thereof, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

30 Since Orion and the Commission have not requested that Teva and Others be ordered to pay the costs, it is appropriate to decide that each party is to bear its own costs.

2. ratiopharm GmbH, Teva Pharma – Produtos Farmaceuticos Lda, Teva Danmark A/S, Teva Sweden AB and Teva Nederland BV, as well as Orion Oyj and the European Commission, shall bear their own costs.

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You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> ratiopharm and Others v Orion and Commission (Appeal - Medicinal products for human use - dexmedetomidine - Order) [2021] EUECJ C-220/21P(I)_CO (24 June 2021) URL: http://www.bailii.org/eu/cases/EUECJ/2021/C22021P(I)_CO.html Cite as: [2021] EUECJ C-220/21P(I)_CO, ECLI:EU:C:2021:521, EU:C:2021:521

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