Information;Order — ECLI:EU:T:2023:489
Date: 2023-09-01
Language of the case: English
Court formation: President of the Chamber
Subject matter: Public health
Procedure: Action for annulment;Application for interim measures - unfounded
Origin: Germany

ORDER OF THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT 6 November 2023 (*) (Intervention – Interest in the result of the case) In Case T‑393/23, Teva GmbH, established in Ulm (Germany), represented by Z. West and G. Morgan, solicitors, and S. Love, Barrister-at-Law, applicant, v European Commission, represented by E. Mathieu and by 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, Teva GmbH, seeks 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 the applicant. 2 By document lodged at the Court Registry on 10 August 2023, Biogen Netherlands B.V. sought leave to intervene in the present case in support of the form of order sought by the 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. It claimed that the contested decision, which relates to the enforcement of the judgment of the Court of Justice of 16 March 2023, Commission and Others v Pharmaceutical Works Polpharma (C‑438/21 P to C‑440/21 P, EU:C:2023:213), directly affects its legal position in that, 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. The Commission did not raise any objections. 6 On 8 September 2023, the applicant raised objections to that application. 7 First, it submits that, contrary to what Biogen maintains, the fact that the contested decision granted Biogen an additional year of marketing protection, in accordance with Article 14(11) of Regulation No 726/2004, is not a consequence of the judgment of the Court of Justice 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 Biogen is therefore not entitled to intervene in the present case solely on the basis of its status in that case. 8 Second, the applicant submits that, in its application for leave to intervene, Biogen failed to describe the current market conditions for Tecfidera in the European Union and therefore failed to demonstrate that it would be directly and adversely affected by the present action. In that regard, it claims that, even after the judgment of the Court of Justice 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 the contested decision, a number of generic copies of Tecfidera continue to be marketed in several markets in the European Union. 9 Third, the applicant considers that a dismissal of Biogen’s application for leave to intervene would not cause any economic harm to Biogen, in so far as the present action does not call into question the validity of the marketing authorisation for Tecfidera or, moreover, affect the current market conditions concerning Tecfidera. The applicant claims that if the present action for annulment were upheld and the period of marketing protection for Tecfidera were amended by a new decision, Biogen would be in a position to challenge that new decision if it so wished. 10 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. 11 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). 12 In the first place, it should be noted that, by the present action, the applicant is seeking the annulment of a Commission decision which is addressed to Biogen in its capacity as the holder of the marketing authorisation for Tecfidera, which, moreover, the applicant does not dispute. 13 In the second place, it is common ground that the contested decision grants Tecfidera an additional year of marketing protection, in accordance with Article 14(11) of Regulation No 726/2004. Furthermore, the contested decision repeals and replaces Commission Implementing Decision C(2022) 3251 (final) of 13 May 2022, a decision addressed to Biogen and by which Biogen was initially denied the entitlement to that additional year of marketing protection for Tecfidera. 14 It follows that, as Biogen submits, 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, which would allow generic copies of Tecfidera to be placed on the market – accordingly, competing with Tecfidera – earlier than what is currently determined in the contested decision. 15 Therefore, contrary to what the applicant maintains (see paragraph 9 above), if the present action for annulment were upheld and the contested decision were annulled, the current market conditions, in particular the conditions of competition, in relation to Tecfidera would be affected and it is likely that Biogen, as the holder of the marketing authorisation for Tecfidera, would suffer economic harm. 16 It follows from the foregoing that, even assuming that the other arguments put forward by the applicant to oppose Biogen’s application for leave to intervene (see paragraphs 7 and 8 above) were well founded, Biogen has a direct, existing interest in the form of order sought by the Commission being upheld and the present action being dismissed. 17 Consequently, Biogen has substantiated its interest in the result of the case. Its application for leave to intervene should therefore be granted. On those grounds, THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT hereby orders: 1. Biogen Netherlands B.V. is granted leave to intervene in Case T‑393/23 in support of the form of order sought by the European Commission. 2. The Registrar shall send a copy 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. 4. The costs are reserved. Luxembourg, 6 November 2023. V. Di Bucci R. da Silva Passos Registrar President * Language of the case: English.