ORDER OF THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT
4 June 2024 (*)
(Intervention)
In Case T‑1183/23,
Zakłady 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 A. Spina and E. Mathieu, acting as Agents,
defendant,
THE PRESIDENT OF THE FOURTH CHAMBER OF THE GENERAL COURT
makes the following
Order
1 By its action under Article 263 TFEU, the applicant, Zakłady Farmaceutyczne Polpharma S.A., seeks the annulment of European Commission Implementing Decision C(2023) 8928 (final) of 13 December 2023 revoking Commission Implementing Decision C(2022) 3253 (final) granting marketing authorisation 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), for ‘Dimethyl fumarate Polpharma – dimethyl fumarate’ (‘Dimethyl fumarate Polpharma’), a medicinal product for human use (‘the contested decision’).
2 By document lodged at the Court Registry on 21 March 2024, Biogen Netherlands B.V. applied for leave to intervene in the present proceedings 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 the contested decision revokes Commission Implementing Decision C(2022) 3253 (final) of 13 May 2022 granting marketing authorisation (‘MA’) under Regulation No 726/2004 for Dimethyl fumarate Polpharma, a generic of the medicinal product for human use Tecfidera – dimethyl fumarate (‘Tecfidera’), for which Biogen holds the MA. It claims that the applicant used Tecfidera as a ‘reference medicinal product’, for the purposes of Article 10 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), for the purpose of obtaining an MA for Dimethyl fumarate Polpharma.
4 Biogen is of the view that, by its action, the applicant is challenging the Commission’s interpretation 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), as well as the data protection and marketing protection of Tecfidera. Biogen also claims that the applicant raises, in the present action, a plea of illegality, under Article 277 TFEU, against Commission Implementing Decision C(2014) 601 (final) of 30 January 2014 granting marketing authorisation for Tecfidera – Dimethyl fumarate, a medicinal product for human use, of which Biogen was the addressee as the holder of the MA for Tecfidera.
5 That application to intervene was served on 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 6 July 2023, the applicant raised objections to that application.
7 First, it is of the view that the outcome of the present case does not directly modify Biogen’s legal position, in as much as the annulment of the contested decision would not, in itself, affect the validity of the MA for the applicant’s generic medicinal product. The applicant points out that that MA was granted to the applicant by another Commission decision, namely Commission Implementing Decision C(2022) 3253 (final) of 13 May 2022, which was the subject of another action for annulment before the General Court, namely Case T‑269/22, Biogen Netherlands v Commission.
8 Second, the applicant submits that Biogen’s interests are safeguarded by means of several actions brought at national level in various Member States of the European Union, seeking in particular to prevent the marketing of generic versions of Tecfidera.
9 Third, the applicant considers that Biogen should not be entitled to 10 years of market protection, since it follows from an opinion of the Committee for Medicinal Products for Human Use of 11 November 2021 that Tecfidera has the same active substance as the medicinal product Fumaderm. The applicant claims that the legal framework for MAs requires scientific progress to be taken into consideration. Furthermore, according to the applicant, the Court of Justice, in 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), failed to take into account the most recent scientific evidence established in that opinion of the Committee for Medicinal Products for Human Use of 11 November 2021.
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 act 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 that regard, it must be noted that the contested decision revokes Commission Implementing Decision C(2022) 3253 (final) and thus withdraws the applicant’s MA for Dimethyl fumarate Polpharma, a generic version of Tecfidera, of which Biogen is the MA holder. In order to obtain the MA for Dimethyl fumarate Polpharma, the applicant had used Tecfidera as a ‘reference medicinal product’ for the purposes of Article 10 of Directive 2001/83.
13 In addition, in its action, the applicant raises a plea of illegality, under Article 263 TFEU, against Commission Implementing Decision C(2014) 601 (final) of 30 January 2014 granting marketing authorisation for Tecfidera, a medicinal product for human use, of which Biogen was the addressee as the holder of the MA for Tecfidera.
14 It follows that the outcome of the present case is liable to affect the data protection and marketing protection of Tecfidera and, therefore, Biogen’s legal position as holder of the MA for that medicinal product.
15 Biogen therefore has a direct, existing interest in the form of order sought by the Commission being upheld and the present action being dismissed.
16 It follows from the foregoing that Biogen has established that it has an interest in the outcome of the case. Consequently, its application for leave to intervene must 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‑1183/23 in support of the form of order sought by the European Commission.
2. The Registrar shall provide Biogen Netherlands with a copy of each procedural document served on the main parties.
3. A time-limit shall be fixed for Biogen Netherlands to submit a statement in intervention.
4. Costs are reserved.
Luxembourg, 4 June 2024.
V. Di Bucci | | R. da Silva Passos |