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COURT","paragraph_id":"para_1"},{"text":"24 June 2021 ( * )","paragraph_id":"para_2"},{"text":"(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)","paragraph_id":"para_3"},{"text":"In Case C‑220/21 P(I),","paragraph_id":"para_4"},{"text":"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,","paragraph_id":"para_5"},{"text":"ratiopharm GmbH, established in Ulm (Germany),","paragraph_id":"para_6"},{"text":"Teva Pharma – Produtos Farmaceuticos Lda, established in Porto Salvo (Portugal),","paragraph_id":"para_7"},{"text":"Teva Danmark A/S, established in Søborg (Denmark),","paragraph_id":"para_8"},{"text":"Teva Sweden AB, established in Stockholm (Sweden),","paragraph_id":"para_9"},{"text":"Teva Nederland BV, established in Haarlem (Netherlands),","paragraph_id":"para_10"},{"text":"represented by O. Swens, advocaat,","paragraph_id":"para_11"},{"text":"appellants,","paragraph_id":"para_12"},{"text":"the other parties to the proceedings being:","paragraph_id":"para_13"},{"text":"Orion Oyj, established in Espoo (Finland), represented by C. Schoonderbeek, advocaat, and by J. Mulryne and E. Amos, Solicitors,","paragraph_id":"para_14"},{"text":"applicant at first instance,","paragraph_id":"para_15"},{"text":"European Commission, represented by L. Haasbeek and R. Lindenthal, acting as Agents,","paragraph_id":"para_16"},{"text":"defendant at first instance,","paragraph_id":"para_17"},{"text":"THE VICE-PRESIDENT OF THE COURT,","paragraph_id":"para_18"},{"text":"after hearing the Advocate General, M. Szpunar,","paragraph_id":"para_19"},{"text":"makes the following","paragraph_id":"para_20"},{"text":"Order","paragraph_id":"para_21"},{"text":"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 t …","paragraph_id":"para_22"},{"text":"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.","paragraph_id":"para_23"},{"text":"3         Orion and the Commission submitted their written observations regarding the appeal on 28 April 2021.","paragraph_id":"para_24"},{"text":"The order under appeal","paragraph_id":"para_25"},{"text":"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.","paragraph_id":"para_26"},{"text":"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 Dexmed …","paragraph_id":"para_27"},{"text":"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 pr …","paragraph_id":"para_28"},{"text":"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.","paragraph_id":"para_29"},{"text":"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 re …","paragraph_id":"para_30"},{"text":"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 decis …","paragraph_id":"para_31"},{"text":"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 interpretati …","paragraph_id":"para_32"},{"text":"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.","paragraph_id":"para_33"},{"text":"The appeal","paragraph_id":"para_34"},{"text":"Arguments","paragraph_id":"para_35"},{"text":"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.","paragraph_id":"para_36"},{"text":"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.","paragraph_id":"para_37"},{"text":"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.","paragraph_id":"para_38"},{"text":"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 Cou …","paragraph_id":"para_39"},{"text":"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 [ …","paragraph_id":"para_40"},{"text":"Assessment","paragraph_id":"para_41"},{"text":"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.","paragraph_id":"para_42"},{"text":"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 so …","paragraph_id":"para_43"},{"text":"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 di …","paragraph_id":"para_44"},{"text":"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 res …","paragraph_id":"para_45"},{"text":"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.","paragraph_id":"para_46"},{"text":"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.","paragraph_id":"para_47"},{"text":"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.","paragraph_id":"para_48"},{"text":"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.","paragraph_id":"para_49"},{"text":"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 St …","paragraph_id":"para_50"},{"text":"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 ( …","paragraph_id":"para_51"},{"text":"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.","paragraph_id":"para_52"},{"text":"28       It follows from all those considerations that the appeal must be dismissed.","paragraph_id":"para_53"},{"text":"Costs","paragraph_id":"para_54"},{"text":"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.","paragraph_id":"para_55"},{"text":"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.","paragraph_id":"para_56"},{"text":"On those grounds, the Vice-President of the Court hereby orders:","paragraph_id":"para_57"},{"text":"1.       The appeal is dismissed.","paragraph_id":"para_58"},{"text":"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.","paragraph_id":"para_59"},{"text":"Luxembourg, 24 June 2021.","paragraph_id":"para_60"},{"text":"A. Calot Escobar","paragraph_id":"para_61"},{"text":"R. 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