Information;Judgment — ECLI:EU:T:2025:902
Date: 2025-09-24
Language of the case: English
Court formation: Fourth Chamber
Procedure: Action for annulment - successful;Action for annulment - inadmissible
Origin: Spain

ORDER OF THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT 30 November 2023 (*) (Intervention – Application for confidential treatment) In Case T‑351/23, Kern Pharma, SL, established in Barcelona (Spain), represented by K. Roox, T. De Meese, J. Stuyck and C. Dumont, lawyers, applicant, v European Commission, represented by E. Mathieu and A. Spina, acting as Agents, defendant, THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT makes the following Order 1 By its application based on Article 263 TFEU, the applicant, Kern Pharma, SL, seeks the annulment 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 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. 2 By document lodged at the Court Registry on 29 August 2023, Biogen Netherlands BV sought leave to intervene in the present case in support of the form of order sought by the European Commission. 3 In particular, Biogen highlighted that it had an interest in the result of the case, since it was the addressee of the contested decision as the holder of the marketing authorisation for Tecfidera and that decision amends the marketing authorisation that was granted to it in 2014 in respect of Tecfidera. Biogen claims that the contested decision directly affects its legal position in so far as, first, it grants Tecfidera an additional year of marketing protection in accordance with Article 14(11) of Regulation No 726/2004 and, second, replaces a previous decision of the Commission of 13 May 2022 which was also addressed to Biogen and by which Biogen was initially denied the entitlement to that additional year of marketing protection. 4 Biogen claims that if the present action for annulment were upheld and the contested decision were annulled, Tecfidera would no longer be entitled to the additional year of marketing protection. According to Biogen, that will directly and negatively affect the market conditions for Tecfidera in the European Union as it will allow the marketing of generic copies of Tecfidera earlier than what is currently determined in the contested decision. 5 That application for leave to intervene was notified to the main parties in accordance with Article 144(1) of the Rules of Procedure of the General Court. The Commission did not raise any objections. 6 On 26 September 2023, the applicant raised objections to that application. It claimed, in particular, that Biogen’s intervention would unreasonably delay the present proceedings and that it would be unjust to allow Biogen to intervene and to frustrate Kern Pharma’s attempts to create legal certainty in a timely manner. 7 By document lodged at the Court Registry on 26 September 2023, the applicant submitted an application for confidential treatment, vis-à-vis Biogen, of certain information appearing in its request for an expedited procedure and in annexes to that request. The application for leave to intervene 8 Under the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union, applicable to proceedings before the General Court in accordance with the first paragraph of Article 53 of that statute, any person which can establish an interest in the result of a case other than a dispute between Member States, between institutions of the Union or between Member States and institutions of the Union, may intervene in that case. 9 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 dispute and be understood as meaning a direct, existing interest in the ruling on the forms of order sought and not as an interest in relation to the pleas in law put forward. The expression ‘result’ of the case is to be understood as meaning the operative part of the final judgment which the parties ask the Court to deliver. It is necessary, in particular, to ascertain whether the intervener is directly affected by the contested measure and whether its interest in the result of the case is established (see order of 21 October 2014, Bayer CropScience v Commission, T‑429/13, EU:T:2014:920, paragraph 21 and the case-law cited). 10 Since, by the present action, the applicant seeks the annulment of a Commission decision of which Biogen was the addressee as the holder of the marketing authorisation for Tecfidera, Biogen has a direct, existing interest in the form of order sought by the Commission being upheld and the present action being dismissed. 11 It follows from the foregoing that Biogen has substantiated its interest in the result of the case. Consequently, its application for leave to intervene must be upheld. The application for confidential treatment 12 The applicant applied, under Article 144(2) of the Rules of Procedure, for certain confidential data appearing in its request for an expedited procedure and in annexes to that request not to be communicated to Biogen and submitted, for the purposes of that communication, a non-confidential version of that request for an expedited procedure and the annexes in question. 13 At this stage, the communication to Biogen of procedural documents already served or to be served on the parties must therefore be limited to non-confidential versions. A decision on the merits of the application for confidential treatment will, if necessary, be taken at a later stage in the light of any objections or observations that may be submitted on that issue. On those grounds, THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT hereby orders: 1. Biogen Netherlands BV is granted leave to intervene in Case T‑351/23 in support of the form of order sought by the European Commission. 2. The Registrar shall send a non-confidential version of all the procedural documents served on the main parties to Biogen Netherlands. 3. A period shall be prescribed within which Biogen Netherlands may submit a statement in intervention, without prejudice to its right to lodge a supplementary statement, if necessary, at a later stage, following a decision on the merits of the application for confidential treatment. 4. A period shall be prescribed within which Biogen Netherlands may submit its observations, if any, on the application for confidential treatment of Kern Pharma, SL. A decision on the merits of that application is reserved. 5. The costs are reserved. Luxembourg, 30 November 2023. V. Di Bucci R. da Silva Passos Registrar President * Language of the case: English.