Judgment;Information — ECLI:EU:T:2025:898
Date: 2025-09-24
Language of the case: English
Court formation: Fourth Chamber
Procedure: Action for annulment - successful
Origin: Poland

ORDER OF THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT 26 September 2023 (*) (Intervention) In Case T‑258/23, Zaklady Farmaceutyczne Polpharma S.A., established in Starogard Gdański (Poland), represented by K. Roox, T. De Meese, J. Stuyck and C. Dumont, lawyers, applicant, v European Commission, represented by E. Mathieu, L. Haasbeek 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, Zaklady Farmaceutyczne Polpharma S.A., 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 it. 2 By document lodged at the Court Registry on 9 June 2023, Biogaran sought leave to intervene in the present case in support of the form of order sought by Polpharma. 3 In particular, Biogaran highlighted that it had an interest in the result of the case. 4 Biogaran claims that, although Biogen Netherlands BV (‘Biogen’) is the holder of a centralised marketing authorisation under Regulation No 726/2004 for the medicinal products (i) Tecfidera 120 mg, gél gastrorésis and (ii) Tecfidera 240 mg, gél gastrorésis (‘Tecfidera’), Polpharma is the manufacturer and supplier of two medicinal products marketed by Biogaran, namely (i) Dimethyl fumarate Biogaran, 120 mg, gél gastrorésis, and (ii) Dimethyl fumarate Biogaran, 240 mg, gél gastrorésis (‘the products’). The products are generics which have Tecfidera as their reference medicine. 5 According to Biogaran, Polpharma granted a license right on the products’ marketing authorisation dossier so that Biogaran was able to obtain its marketing authorisation, with the result that Biogaran is the holder of its own marketing authorisation regarding the products, including in France and Germany. 6 Biogaran claims that it has the right to intervene in the present proceedings due to the adverse effects that the implementation of the contested decision would have on its business, in particular since Biogaran holds existing and valid marketing authorisations for the products, which are generic versions of Tecfidera, and has an established commercial relationship with the applicant, which granted Biogaran a license right. Biogaran claims that if the contested decision is not annulled, Biogen and the national authorities will prevent Biogaran, as a marketing authorisation holder for the products, from marketing them. 7 That application for leave to intervene was notified to the main parties in accordance with Article 144(1) of the Rules of Procedure. Polpharma did not raise any objections. 8 On 14 July 2023, the Commission raised objections to that request. It claimed, inter alia, that the fact that Biogaran would be prevented from marketing its products based on Dimethyl fumarate until the end of the marketing protection period from which Tecfidera benefits does not primarily flow from the contested decision, but rather from the 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), which reinstated Tecfidera’s regulatory protection rights as provided for in Article 14(11) of Regulation No 726/2004. According to the Commission, the additional one-year period of marketing protection (from 3 February 2024 to 2 February 2025 inclusive) granted through the contested decision is entirely dependent on the fact that, as a consequence of the 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), Tecfidera benefits from its own independent (data protection and) marketing protection period. 9 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. 10 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). 11 The Court notes, first, as Biogaran pointed out without being challenged in that regard by the Commission, Polpharma granted Biogaran a license right on the marketing authorisation dossier for the products, with the result that Biogaran is the holder of its own marketing authorisation for the products, in particular in France and Germany. Biogaran therefore holds existing and valid marketing authorisations for the products, which are generic versions of Tecfidera. 12 Second, contrary to what is argued by the Commission, while it is true that the 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) reinstated Tecfidera’s regulatory protection rights as provided for in Article 14(11) of Regulation No 726/2004, the fact remains that, by the contested decision, the Commission took measures to comply with that judgment. The Court notes, in that regard, that according to recital 9 of the contested decision ‘in accordance with Article 266 of the Treaty on the Functioning of the European Union, the Commission takes the necessary measures to comply with the final judgment of the Court of Justice of the European Union …’. 13 Thus, in the same way as the contested decision, in compliance with the 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), reinstates Tecfidera’s marketing protection and therefore has the consequence of preventing Polpharma from marketing the products until 2 February 2025, it follows from the contested decision that, for the same reasons, Biogaran, as holder of a marketing authorisation for the products, is prevented from marketing them until 2 February 2025. 14 Therefore, Biogaran is prevented from marketing its products based on Dimethyl fumarate until the end of the marketing protection period from which Tecfidera benefits as a direct result of the contested decision, by which the Commission took measures to comply with the 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). 15 Biogaran therefore has a direct, existing interest in the form of order sought by the applicant and the contested decision being annulled. 16 It follows from the foregoing that Biogaran has substantiated its interest in the result of the case. Consequently, its application for leave to intervene must be upheld. On those grounds, THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT hereby orders: 1. Biogaran is granted leave to intervene in Case T‑258/23 in support of the form of order sought by Zaklady Farmaceutyczne Polpharma S.A. 2. The Registrar shall send a copy of all the procedural documents served on the main parties to Biogaran. 3. A period shall be prescribed within which Biogaran may submit a statement in intervention. 4. The costs are reserved. Luxembourg, 26 September 2023. V. Di Bucci R. da Silva Passos Registrar President * Language of the case: English.