JUDGMENT OF THE GENERAL COURT (Fourth Chamber)
11 February
2026 (*)
( Medicinal products for human use – Revocation of the marketing authorisation for Dimethyl Fumarate Polpharma – dimethyl fumarate, a medicinal product for human use – Directive 2001/83/EC – Regulation (EC) No 726/2004 – Article 266 TFEU )
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,
supported by
Biogaran, established in Colombes (France), represented by C. Mereu and S. Englebert, lawyers,
intervener,
v
European Commission, represented by E. Mathieu and A. Spina, acting as Agents,
defendant,
supported by
Biogen Netherlands BV, established in Amsterdam (Netherlands), represented by C. Schoonderbeek, lawyer,
intervener,
THE GENERAL COURT (Fourth Chamber),
composed, at the time of the deliberations, of R.
da Silva Passos (Rapporteur), President, I. Reine and T. Pynnä, Judges,
Registrar: A. Marghelis, Administrator,
having regard to the order of 29 February 2024, Zakłady Farmaceutyczne Polpharma v Commission (T‑1183/23 R, not published, EU:T:2024:139),
having regard to the written part of the procedure,
further to the hearing on 19 June 2025,
gives the following
Judgment
1        By its action under Article 263 TFEU, the applicant, Zakłady Farmaceutyczne Polpharma S.A., seeks the annulment of Commission Implementing Decision C(2023) 8928 final of 13 December 2023 revoking Decision C(2022) 3253 final granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for ‘Dimethyl Fumarate Polpharma – dimethyl fumarate’, a medicinal product for human use (‘the contested decision’).
Background to the dispute and facts subsequent to the bringing of the action
2        The applicant is a pharmaceutical company that develops and markets various medicinal products, including generic medicinal products.
3        On 9 August 1994, the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices, Germany; ‘the BfArM’) granted Fumapharm AG two marketing authorisations (‘MAs’)
concerning two strengths of a medicinal product called Fumaderm. Fumaderm was authorised as a fixed combination medicinal product of dimethyl fumarate (‘DMF’) and various monoethyl fumarate (‘MEF’) salts. In June 2013, the two MAs for Fumaderm were renewed. Fumaderm is indicated for the treatment of psoriasis.
4        The intervener in support of the Commission, Biogen Netherlands BV (‘Biogen’), is the current holder of the MAs for Fumaderm.
5        On 28 February 2012, Biogen, pursuant to Article 3(2)(b) and Article 4(1) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1), submitted to the European Medicines Agency (EMA) an application for an
MA for the medicinal product for human use Tecfidera – Dimethyl fumarate (‘Tecfidera’). In that application, Biogen stated that Tecfidera was intended for the treatment of adult patients suffering from multiple sclerosis and that its only active substance was DMF. Moreover, in that same application, it did not request that the ‘new active substance’ status, within the meaning 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), of DMF in Tecfidera be assessed.
6        On 21 March 2013, the EMA’s Committee for Medicinal Products for Human Use (‘the CHMP’), established by Article 5 of Regulation No 726/2004, issued a positive opinion on granting an
MA for Tecfidera (‘the opinion of 21 March 2013’). In the light of the content of Biogen’s application, the CHMP did not examine whether DMF was a ‘new active substance’.
7        By letter of 18 September 2013, the European Commission, with a view to determining whether DMF was a ‘new active substance’ within the meaning of Directive 2001/83, requested the CHMP to assess whether Tecfidera, which is composed of DMF, was different from Fumaderm, which is composed of DMF and MEF salts. By that letter, and following a request from Biogen, the Commission asked the CHMP to reconsider its assessment report so as to include an assessment of the ‘new active substance’ status of DMF in Tecfidera.
8        On 21 November 2013, the CHMP delivered a revised opinion as compared with the opinion of 21 March 2013 (see paragraph
6 above) (‘the opinion of 21 November 2013’). In that revised opinion, the CHMP recommended, inter alia, by consensus, the granting of an
MA for Tecfidera. In addition, it considered that DMF was different from Fumaderm, which is composed of DMF and MEF salts, and deduced from this that the active substance in Tecfidera, DMF, was a ‘new active substance’. The CHMP therefore concluded that DMF and MEF were both active and were not the same active substance, since they did not share the same therapeutic moiety.
9        On 26 November 2013, the CHMP adopted, pursuant to Article 13(3) of Regulation No 726/2004, the European Public Assessment Report (‘the EPAR’) for Tecfidera.
10      The Commission subsequently adopted Implementing Decision C(2014) 601 final of 30 January 2014 granting marketing authorisation under Regulation No 726/2004 of the European Parliament and of the Council for ‘Tecfidera – Dimethyl fumarate’, a medicinal product for human use (‘the implementing decision of 30 January 2014’). That implementing decision was notified to Biogen on 3 February 2014.
11      Recital 3 of the implementing decision of 30 January 2014 was worded as follows:
‘[DMF], the active substance of “Tecfidera – Dimethyl fumarate”, is part of the composition of the authorised medicinal product Fumaderm which [consists] of DMF and calcium salt of ethyl fumarate, magnesium salt of ethyl hydrogen fumarate and zinc salt of ethyl hydrogen fumarate (MEF salts), belonging to the same [MA] holder. The [CHMP] concluded that MEF and DMF are both active and are not the same active substance since they do not share the same therapeutic moiety. Therefore it is considered that Tecfidera containing DMF is different from Fumaderm, the other already authorised medicinal product composed of DMF and MEF salts. Therefore “Tecfidera – Dimethyl fumarate”, the application of which was based on Article 8(3) of Directive [2001/83], and the already authorised medicinal product Fumaderm do not belong to the same global [MA] as described in Article 6(1) of Directive [2001/83].’
12      On 27 November 2017, Pharmaceutical Works Polpharma S.A. (‘Polpharma’) submitted a request to the EMA for confirmation that it was eligible to submit an application for an
MA under the centralised procedure in accordance with Article 3(3) of Regulation No 726/2004 for a generic medicinal product known as Dimethyl Fumarate Pharmaceutical Works Polpharma, derived from the reference medicinal product Tecfidera.
13      By decision of 30 July 2018 (‘the EMA decision of 30 July 2018’), the EMA informed Polpharma that it was unable to validate its application, referred to in paragraph
12 above. The EMA stated, inter alia, that, according to recital 3 of the implementing decision of 30 January 2014, Tecfidera and the already authorised medicinal product Fumaderm did not belong to the same global MA within the meaning of the second subparagraph of Article 6(1) of Directive 2001/83, on the ground that MEF and DMF were both active and did not correspond to the same active substance since the therapeutic moiety was not the same in each of those medicinal products. Consequently, the EMA took the view that Tecfidera benefitted from its own eight-year regulatory data protection period and that that period of protection had not yet expired.
14      By application lodged at the Registry of the General Court on 9 October 2018, Polpharma brought an action for annulment of the EMA decision of 30 July 2018. It submitted a plea of illegality under Article 277 TFEU against the implementing decision of 30 January 2014, which constituted the legal basis of the EMA decision of 30 July 2018.
15      By judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), the General Court upheld the plea of illegality raised by Polpharma in the action referred to in paragraph
14 above and declared the implementing decision of 30 January 2014 inapplicable. Accordingly, the EMA decision of 30 July 2018, which was based on the implementing decision of 30 January 2014, had no legal basis and was annulled. The General Court held, inter alia, in paragraph 282 of that judgment, that, in view of the objectives of global MAs, the EU law applicable to combination medicinal products in 1994 and the development of scientific knowledge between 1994 and 2014, the particular function performed by the EMA and the Commission, and the data available, or which could have been available, to them which rendered implausible the theory that MEF played a role within Fumaderm, it had to be held that the Commission was not entitled to conclude that Tecfidera was covered by a different global MA than Fumaderm, which had previously been authorised, without verifying or requesting the CHMP to verify whether and, if necessary, how the BfArM had assessed the role of MEF within Fumaderm, or without requesting the CHMP to verify the role played by MEF within Fumaderm.
16      The Commission, Biogen and the EMA each brought an appeal against the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241).
17      On 30 May 2021, the applicant submitted to the EMA an application for an
MA for the generic medicinal product Dimethyl Fumarate Polpharma. In that application, submitted under the centralised procedure, in accordance with Article 3(3) of Regulation No 726/2004, the applicant designated Tecfidera as the reference medicinal product.
18      On 2 June 2021, Biogen submitted an application for a variation of its MA for Tecfidera seeking the extension of the therapeutic indication of that medicinal product to include treatment of relapsing remitting multiple sclerosis in patients aged 10 years and older. At the same time, and on account of that application to extend the therapeutic indication, Biogen also requested a one-year extension of the marketing protection for Tecfidera, pursuant to Article 14(11) of Regulation No 726/2004.
19      In the course of implementing the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), the CHMP, on 11 November 2021, adopted a new assessment report concerning the therapeutic effect of MEF within Fumaderm (‘the report of 11 November 2021’). The CHMP recalled the subject matter of that report, stating that, ‘for the purpose of the implementation of the [j]udgment of the General Court of 5 May 2021 in Case T‑611/18, Pharmaceutical Works Polpharma v EMA, and in connection to … three pending applications before the CHMP which concern DMF …, the CHMP is being asked to examine whether MEF exerts a clinically relevant therapeutic contribution within Fumaderm’. It also explained that, ‘in the situation whereby the General Court annuls an act of an institution or body, it is required, in accordance with Article 266 [TFEU], to take measures necessary to comply with that judgment’ and that ‘the present ad hoc assessment [was] considered to conform to that requirement in view of the particular findings of the General Court in Case T‑611/18’.
20      In its report of 11 November 2021, the CHMP concluded
as follows:
‘The available clinical data is not conclusive for the purpose of establishing that MEF has a clinically relevant therapeutic contribution within Fumaderm. … Taking into account the described results, including the severe methodological limitations of the clinical studies, it cannot be concluded based on these data that a clinically relevant therapeutic effect of MEF in Fumaderm has been demonstrated. Therefore, the CHMP concludes that the totality of the available data cannot establish that MEF exerts a clinically relevant therapeutic contribution within Fumaderm.’
21      On 27 January 2022, the CHMP adopted an initial opinion on the applications made by Biogen referred to in paragraph
18 above (‘the CHMP’s opinion of 27 January 2022’). First, it recommended that the requested variation to include an additional therapeutic indication in the MA for Tecfidera be granted and concluded that the new therapeutic indication provided
a significant clinical benefit in comparison to existing therapies. Secondly, it recommended that the grant of an additional one
year of marketing protection be refused.
22      The EPAR of 24 February 2022 for Dimethyl Fumarate Polpharma states as follows:
‘In the light of the scientific conclusions outlined in its Opinion of 11 November 2021, the CHMP is of the view that the totality of the available data cannot establish that MEF exerts a clinically relevant therapeutic contribution within Fumaderm. Those scientific conclusions and the [j]udgment of the General Court of 5 May 2021 in Case T‑611/18 support the determination that Tecfidera does not benefit from an independent global marketing authorisation. This also entails that, following the General Court’s reasoning, Tecfidera could not benefit, at the time of the submission of this generic application, from any marketing protection. This position is without prejudice to the outcome of the above referenced appellate proceedings.’
23      On the same date, namely 24 February 2022, the CHMP adopted an opinion (‘the opinion of 24 February 2022’) recommending the authorisation of the MA for Dimethyl Fumarate Polpharma submitted by the applicant on 30 May 2021 (see paragraph
17 above). That opinion made it clear
that its position was without prejudice to the outcome of the appeal proceedings initiated against the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241).
24      On 13 May 2022 the Commission adopted Implementing Decision C(2022) 3253 final granting marketing authorisation under Regulation No 726/2004 of the European Parliament and of the Council for ‘Dimethyl fumarate Polpharma – dimethyl fumarate’, a medicinal product for human use (‘the implementing decision of 13 May 2022’).
25      On the same day, namely 13 May 2022, the Commission adopted Implementing Decision C(2022) 3251 final amending the marketing authorisation granted by the implementing decision of 30 January 2014 (see paragraph
10 above). The Commission, first, granted Biogen’s application to extend the MA for Tecfidera by adding a paediatric indication and, accordingly, amended Annexes I to III to the implementing decision of 30 January 2014. Secondly, it refused to grant an additional year of marketing protection for Tecfidera, as requested by Biogen pursuant to Article 14(11) of Regulation No 726/2004.
26      On 16 May 2022, Biogen brought an action for annulment, based on Article 263 TFEU, against the implementing decision of 13 May 2022.
27      By 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), the Court of Justice set aside the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241). Ruling subsequently on the action at first instance, the Court of Justice rejected the single plea in law alleging illegality of the implementing decision of 30 January 2014 and, therefore, dismissed the action.
28      On 17 March 2023, the Commission sent the applicant a letter in which, first, it observed that, 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), the Court of Justice had confirmed the right to data protection of Tecfidera and the marketing protection period of that reference medicinal product, which was still ongoing as at that date. Secondly, the Commission requested that the applicant act in compliance with the duration of that marketing protection period of Tecfidera, inter alia by providing it with a written commitment to that effect. The Commission also reserved its right to take any further regulatory action on the basis of that judgment of the Court of Justice.
29      On 2 May 2023, the Commission adopted Implementing Decision C(2023) 3067 final granting Biogen an additional year, that is to say, until 2 February 2025, of marketing protection for Tecfidera, in accordance with Article 14(11) of Regulation No 726/2004. That implementing decision was annulled by the judgment of 24 September 2025, Zakłady Farmaceutyczne Polpharma v Commission
(T‑258/23, not published, EU:T:2025:898).
30      On 27 September 2023, the Commission informed the applicant of its intention to revoke the MA which the applicant had been granted for Dimethyl Fumarate Polpharma by the implementing decision of 13 May 2022 and invited the applicant to submit observations within 10
working days.
31      On 13 December 2023, the Commission adopted the contested decision.
32      By order of 10 April 2024, Biogen Netherlands v Commission (T‑269/22, not published, EU:T:2024:233), the General Court decided that there was no longer any need to adjudicate on the action referred to in paragraph 26 above.
33      Since the adoption of the contested decision, pharmaceutical undertakings which re-submitted MA applications for their respective generic version of Tecfidera have obtained a new MA for their medicinal products. In addition, upon informing the applicant of the adoption of the contested decision, the Commission also informed it that the revocation of the MA by the contested decision did not impede it from applying for a new MA for a generic medicinal product of Tecfidera and that, should such an application be submitted, it would be subject to an accelerated assessment timeline and a reduced fee.
Forms of order sought
34      The applicant claims that the Court should:
–        annul the contested decision;
–        order the Commission to pay the costs.
35      The intervener in support of the applicant, Biogaran, claims that the Court should annul the contested decision.
36      The Commission, supported by Biogen, contends that the Court should:
–        declare that the action has become devoid of purpose and that there is no longer any need to adjudicate on it;
–        in the alternative, dismiss the action;
–        order the applicant to pay the costs.
Law
Admissibility of some of the applicant’s arguments
37      In the rejoinder, the Commission disputes the admissibility of some of the applicant’s arguments raised in the reply, to the effect that the Commission contradicts itself as compared with statements that it made in the context of other actions
before the Court. The Commission submits that this is an attempt to circumvent the rules on the admissibility of evidence and the decision by the Court not to place in the case file certain pieces of evidence produced with the application.
38      In the present case, in paragraphs 5, 6 and 43 of the reply, the applicant referred to statements made by the Commission in pleadings relating to other proceedings before the Court, in particular those which gave rise to the order of 10 April 2024, Biogen Netherlands v Commission (T‑269/22, not published, EU:T:2024:233), and to the judgment of 24 September 2025, Zakłady Farmaceutyczne Polpharma v Commission (T‑258/23, not published, EU:T:2025:898).
39      In that regard, first, it must be borne in mind that each case brought before the Court has its own case file containing, inter alia, the documents and pleadings produced by the parties to the case in question and that each case file is completely separate. According to point 26 of the Practice Rules for the Implementation of the Rules of Procedure of the General Court, ‘a procedural document and annexes thereto which are produced in a case and placed on the file of that case may not be taken into account for the purpose of preparing another case for hearing’ (see, by analogy, order of 15 October 2009, Hangzhou Duralamp Electronics v Council, T‑459/07, EU:T:2009:403, paragraph 12).
40      Secondly, it must be pointed out that it is settled case-law that, according to the rules governing the treatment of cases before the Court, parties are entitled to protection against the misuse of pleadings and that, therefore, the parties to a case, whether the main parties or interveners, have the right to use the pleadings of other parties to which they have been granted access solely for the purpose of defending their own legal position in the context of that case (see order of 15 October 2009, Hangzhou Duralamp Electronics v Council, T‑459/07, EU:T:2009:403, paragraph 13 and the case-law cited).
41      Admittedly, it is settled case-law that, apart from exceptional cases in which disclosure of a document might adversely affect the proper administration of justice, parties to proceedings are free to disclose their own written submissions to parties not involved in those proceedings. Likewise, a party to proceedings may, subject to the same proviso, consent to a pleading which it presented in the context of those proceedings being used by another party thereto in the context of separate proceedings (see order of 15 October 2009, Hangzhou Duralamp Electronics v Council, T‑459/07, EU:T:2009:403, paragraph 14 and the case-law cited).
42      However, in the present case, it is established that the Commission disputes the use, in the context of the present case, of pleadings or extracts from pleadings which it lodged in the cases that
gave rise to the order of 10 April 2024, Biogen Netherlands v Commission (T‑269/22, not published, EU:T:2024:233), and to the judgment of 24 September 2025, Zakłady Farmaceutyczne Polpharma v Commission (T‑258/23, not published, EU:T:2025:898), since the applicant did not even seek permission to make such use.
43      Lastly, it must be pointed out that, if it were to take the view that the pleadings in question might be of use in resolving the present dispute, the Court could, in any event, order their production pursuant to Article 89(3)(d) or Article 91(b) of its Rules of Procedure.
44      Accordingly, the statements made by the applicant in paragraphs 5, 6 and 43 of the reply are inadmissible, in so far as reference is made therein to statements made by the Commission in pleadings concerning the cases which gave rise to the order of 10 April 2024, Biogen Netherlands v Commission (T‑269/22, not published, EU:T:2024:233), and to the judgment of 24 September 2025, Zakłady Farmaceutyczne Polpharma v Commission (T‑258/23, not published, EU:T:2025:898). Those statements will not therefore be taken into account by the Court in the examination of the present action.
Substance
45      In support of its action, the applicant relies on nine pleas in law. By the first plea in law, it claims that the Commission infringed Articles 5, 13, 14(11) and 81 of Regulation No 726/2004. The second plea in law alleges a misuse of powers. In the third plea in law, the applicant claims that the Commission made a manifest error in interpreting the scope 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). By the fourth plea in law, the applicant claims that the Commission made a manifest error in basing the contested decision on inaccurate scientific facts. In the fifth plea in law, the applicant raises a plea of illegality against the implementing decision of 30 January 2014. The sixth plea in
law alleges a breach of essential procedural requirements and of a number of the applicant’s fundamental rights. By the seventh plea in law, the applicant claims that the Commission infringed the principle of legal certainty. In the eighth plea in law, the applicant alleges
an infringement by the Commission, in the contested decision, of the principle of the protection of legitimate expectations. The ninth plea in law concerns an infringement by the Commission of the applicant’s right to property and of the principle of proportionality.
46      First and foremost, it is necessary in the present action to answer the question whether, in adopting the contested decision, the Commission, first, took into account all the available scientific knowledge concerning the data protection and the marketing protection for Tecfidera, as a reference medicinal product for Dimethyl Fumarate Polpharma, and, secondly, whether it observed the scope 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).
47      It is therefore necessary, first of all, to carry out a joint analysis of the third and fourth pleas in law.
Third and fourth pleas in law
48      In the third plea in law, the applicant submits, in essence, that the Commission made a manifest error in the contested decision by taking the view that, in interpreting 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), it was not required to take account of the report of 11 November 2021, in which the CHMP had concluded that the totality of the available data could not establish that MEF exerted a clinically relevant therapeutic contribution within Fumaderm. According to the Commission, that report is no longer relevant following that judgment of the Court of Justice.
49      In the first place, the applicant submits that, 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), the Court of Justice did not conclude that, in order to assess the scope of the global MA for Fumaderm in relation to Tecfidera, a new (later) verification of the relevant therapeutic contribution of MEF within Fumaderm would be an illegal assessment, nor that the report of 11 November 2021 would consequently have been null and void. The applicant submits that, in that judgment, the Court of Justice merely held that the General Court could not require the CHMP to make such an assessment, which would not automatically render the report of 11 November 2021 wholly invalid or irrelevant. In addition, according to the applicant, the Court of Justice merely held that the Commission was not obliged to request, in 2014, a review of the question of the therapeutic contribution of MEF within Fumaderm, in view of the opinion of 21 November 2013, which had been issued at that time, and did not take the view that the scientific evidence that emerged after the MA for Tecfidera had been granted in 2014 or the report of 11 November 2021 could be ignored.
50      In the second place, the applicant argues 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), is a decision dealing exclusively with the question of the legality of the contested decision in that case not to validate an application for an
MA submitted in 2018, and based on the facts as presented at the time of the judgment’s delivery, for a DMF-based generic medicinal product derived from the reference medicinal product Tecfidera, whereas the contested decision in the present case deprives it of the possibility of using its own MA, which was granted to it unconditionally.
51      In the third place, the applicant submits that, 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), the Court of Justice did not confirm that the marketing protection for Tecfidera had been resurrected. According to the applicant, the Court of Justice merely ruled that, in the contested decision in that case, the EMA had not committed a manifest error of assessment by referring to recital 3 of the decision of 30 January 2014 to find that Tecfidera was not covered by the same global authorisation as Fumaderm.
52      In that regard, the applicant claims that the report of 11 November 2021 explicitly refers to scientific conclusions, on the one hand, and to the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), on the other hand. In other words, in the applicant’s submission, although that judgment of the General Court was set aside, the scientific conclusions contained in the report of 11 November 2021 remained relevant and should therefore have been taken into consideration by the Commission.
53      In the fourth plea in law, the applicant submits that there is no reason to disregard the report of 11 November 2021, of which the assessment constitutes the current state of scientific knowledge on the therapeutic effect of MEF within Fumaderm and, therefore, on
the question of whether or not Fumaderm and Tecfidera belong to the same global MA, within the meaning of Article 6(1) of Directive 2001/83. The applicant claims that, contrary to what Biogen appears to argue, Tecfidera’s entitlement to regulatory data protection cannot be unalterable simply because the Court of Justice held that the implementing decision of 30 January 2014, adopted on the basis of scientific facts in 2014, was not vitiated by a manifest error of assessment.
54      According to the applicant, the contested decision is based on outdated scientific evidence, whereas the legal framework for MAs requires scientific progress to be taken into consideration. The applicant observes in that regard that Article 16(2) and Article 17 of Regulation No 726/2004, read in conjunction with recital 19 of that regulation, require the MA holder to consider technical and scientific progress throughout the life of a medicinal product, and to make any amendments that may be required.
55      The applicant argues that, although 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), considered that the CHMP’s scientific assessment in the opinion of 21 November 2013, which had concluded that Tecfidera and Fumaderm did not belong to the same global MA, was sufficient to comply with the relevant provisions at the time, the fact remains that, since the implementing decision of 30 January 2014, scientific evidence and understanding have evolved. There is therefore, in the applicant’s submission, a fundamental difference between stating, as the Court of Justice did, that an additional verification was not required and asserting that the verification carried out is irrelevant to the adoption of the contested decision.
56      The Commission, supported by Biogen, disputes those arguments.
57      In the first place, as a preliminary point, it must be recalled that Article 6(1) of Directive 2001/83 states as follows:
‘No medicinal product may be placed on the market of a Member State unless [an
MA] has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with [Regulation]
No 726/2004 …
When a medicinal product has been granted an initial [MA] in accordance with the first subparagraph [of this article], any additional strengths, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions shall also be granted an authorisation in accordance with the first subparagraph [of this article] or be included in the initial [MA]. All these [MAs] shall be considered as belonging to the same global [MA], in particular for the purpose of the application of Article 10(1).’
58      In addition, it must be pointed out that Article 14(11) of Regulation No 726/2004 reads as follows:
‘Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with the provisions of this Regulation shall benefit from an [8]-year period of data protection and a [10]-year period of marketing protection, in which connection the latter period shall be extended to a maximum of 11 years if, during the first [8] years of those [10] years, the [MA] holder obtains an authorisation for one or more new therapeutic indications which, during the scientific evaluation prior to their authorisation, are held to bring a significant clinical benefit in comparison with existing therapies.’
59      In the second place, it must be borne in mind that, in paragraph 282 of the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), the General Court found that the Commission was not entitled to conclude that Tecfidera was covered by a different global MA than Fumaderm without verifying or requesting the CHMP to verify whether and, if necessary, how the BfArM had assessed the role of MEF within Fumaderm, and without requesting the CHMP to verify the role played by MEF within Fumaderm.
60      In paragraph 293 of the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), the General Court decided, in so far as neither the CHMP nor the Commission had assessed the role played by MEF within Fumaderm or requested information from the BfArM in that regard, to uphold the applicant’s single plea in law, alleging that the implementing decision of 30 January 2014 was vitiated by a manifest error of assessment inasmuch as the Commission had concluded in that implementing decision that Tecfidera did not belong to the same global MA as Fumaderm.
61      It is in those circumstances that the report of 11 November 2021 was requested from the CHMP. As that report states, ‘for the purpose of the implementation of the judgment of the General Court of 5 May 2021 in Case T‑611/18, Pharmaceutical Works Polpharma v EMA, and in connection to the … pending applications before the CHMP which concern DMF (two [MAs] for a generic version of Tecfidera; and a type II variation for Tecfidera), the CHMP [was] asked to examine whether MEF exert[ed] a clinically relevant therapeutic contribution within Fumaderm’.
62      In addition, the CHMP recalls in the report of 21 November 2021 that, ‘in the situation whereby the General Court annuls an act of an institution or body, it is required, in accordance with Article 266 [TFEU], to take measures necessary to comply with that judgment’ and that ‘the present ad hoc assessment is considered to conform to that requirement in view of the particular findings of the General Court in Case T‑611/18’.
63      In the third place, it must be stated that, in paragraphs 86 and 93 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), the Court of Justice considered that the wording of the second subparagraph of Article 6(1) of Directive 2001/83 and the context in which that provision occurred did not mean that the concept of a ‘global [MA]’ applied to medicinal products with different qualitative compositions.
64      The Court of Justice thus found, in paragraph 87 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), that the difference in the qualitative composition of a medicinal product due to the replacement of the active substance(s) of that medicinal product by another substance or substances with a different therapeutic moiety cannot be classified as a ‘variation and extension’ within the meaning of the second subparagraph of Article 6(1) of Directive 2001/83.
65      It is in that context that, in paragraph 88 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), the Court of Justice referred to the fact that the CHMP had found, in the assessment which had preceded the adoption of the implementing decision of 30 January 2014, that Fumaderm, which contains DMF and MEF, and Tecfidera, which contains DMF as a mono-substance, were different, since DMF and MEF did not have the same therapeutic moiety and therefore did not correspond to the same active substance.
66      In paragraph 89 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), the Court of Justice therefore found that such an assessment by the CHMP was sufficient for the purpose of determining whether or not the medicinal products in question belonged to the same global MA within the meaning of the second subparagraph of Article 6(1) of Directive 2001/83.
67      It is in that context that the Court of Justice held that the objectives of the second subparagraph of Article 6(1) of Directive 2001/83 cannot in themselves justify the need to verify, beyond a qualitative comparison of the medicinal products with different qualitative compositions in order to assess whether they belong to the same global MA, the therapeutic contribution of the active substance or substances of the first medicinal product authorised (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, paragraph 93).
68      According to the Court of Justice, the General Court had therefore erred in law in holding that, in the context of the assessment as to whether two medicinal products belong to the same global MA within the meaning of Article 6(1) of Directive 2001/83, as interpreted by the case-law of the Court of Justice, the Commission was required to verify that the active substance in the first medicinal product authorised at national level had a therapeutic contribution that the composition of the medicinal product subsequently authorised by the Commission itself did not (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, paragraph 94), that is to say, to verify that MEF has a therapeutic contribution within Fumaderm.
69      In that regard, it must be borne in mind that the subject of the report of 11 November 2021 was the assessment of the therapeutic contribution of MEF within Fumaderm (see paragraph
61 above), whereas, as the Commission and Biogen have rightly argued, the therapeutic contribution of MEF within Fumaderm was not regarded by the Court of Justice as a necessary criterion to determine whether Tecfidera and Fumaderm were covered by the same global MA (see paragraphs
67 and 68 above).
70      As follows from paragraphs
65 and 66 above, according to the Court of Justice, it is sufficient to find that, since DMF and MEF do not have the same therapeutic moiety in Fumaderm and Tecfidera and do not therefore correspond to the same active substance, those medicinal products are different and do not therefore belong to the same global MA, within the meaning of the second subparagraph of Article 6(1) of Directive 2001/83.
71      The Commission and Biogen are therefore right to contend that, in accordance 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), the test, referred to in paragraph
70 above, applied in the implementing decision of 30 January 2014, following the opinion of 21 November 2013, in order to conclude that Tecfidera and Fumaderm did not belong to the same global MA was sufficient in that regard.
72      The question whether or not it can be concluded, based on the report of 11 November 2021, that MEF had a clinically relevant therapeutic contribution within Fumaderm and whether or not such a report contains new scientific facts about the therapeutic role of MEF within Fumaderm is therefore irrelevant in the present case. Such aspects are irrelevant in the context of the examination which enabled the Court of Justice to find that, since DMF and MEF did not have the same therapeutic moiety and did not therefore correspond to the same active substance in, on the one hand, Fumaderm, composed of DMF and MEF, and, on the other hand, Tecfidera, composed of DMF as a mono-substance, the two medicinal products were different.
73      It follows that the report of 11 November 2021 carried out an assessment which, in the view of the Court of Justice, was unnecessary in order to assess whether or not Fumaderm belonged to the same global MA, within the meaning of Article 6(1) of Directive 2001/83, since
the assessment conducted in the opinion of 21 November 2013 was sufficient in that regard.
74      In the fourth place, it must be borne in mind that, according to settled case-law, as a consequence of a judgment of annulment, which takes effect ex tunc and thus has the effect of retroactively eliminating the annulled measure from the legal system, the defendant institution is required, by virtue of Article 266 TFEU, to take the necessary measures to reverse the effects of the illegalities found, which, in the case of an act that has already been executed, may take the form of restoring the applicant to the position it
was in prior to that act (see judgment of 10 October 2001, Corus UK v Commission, T‑171/99, EU:T:2001:249, paragraph 50 and the case-law cited).
75      The measures referred to in paragraph
74 above do not concern the elimination of the act as such from the EU legal order, since that is the very essence of its annulment by the judicature. They involve, rather, the removal of the effects of the illegalities found in the judgment annulling the act, so as to resolve them in accordance with EU law (see, to that effect, judgments of 31 March 1971, Commission v Council, 22/70, EU:C:1971:32, paragraph 60, and of 14 September 1995, Antillean Rice Mills and Others v Commission, T‑480/93 and T‑483/93, EU:T:1995:162, paragraph 60 and the case-law cited).
76      In the light of the case-law cited in paragraphs
74 and 75 above, it fell to the Commission and the EMA, in the context of implementing 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), to take the necessary measures to restore Biogen to the situation which it, as the holder of the MAs for Fumaderm and Tecfidera, was in prior to the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), which was set aside by the Court of Justice.
77      However, since the obligation to act under Article 266 TFEU does not, in itself, constitute a source of competence for the Commission (see, to that effect, judgment of 14 June 2016, Commission v McBride and Others, C‑361/14 P, EU:C:2016:434, paragraph 38 and the case-law cited), the Commission is obliged to comply with the judgments of the Court of Justice in accordance with the applicable EU law, of which it is the guardian.
78      Therefore, the contested decision was adopted in pursuance 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), and the implementing decision of 30 January 2014 remains valid with retroactive effect, in accordance with the conclusion set out in paragraph
76 above.
79      It therefore follows that, first, the finding, in recital 3 of the implementing decision of 30 January 2014, that Tecfidera does not belong to the same global MA, within the meaning of the second subparagraph of Article 6(1) of Directive 2001/83, as Fumaderm and, secondly, the data protection of Tecfidera and the marketing protection of that medicinal product, in the light of Article 14(11) of Regulation No 726/2004, also remain valid.
80      Thus, the measures to be taken by the Commission and the EMA in the implementation
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), in accordance with Article 266 TFEU, had to cover, inter alia, the MA for the applicant’s medicinal product, that is to say, Dimethyl Fumarate Polpharma. That MA had become illegal in the light of the finding of legality, made in that judgment of the Court of Justice, of the implementing decision of 30 January 2014.
81      It follows from all the foregoing that the third and fourth pleas in law must be rejected.
The first plea in law
82      The first plea in law, which concerns the infringement of Articles 5, 13, 14(11) and 81 of Regulation No 726/2004, is divided into three parts, alleging, respectively, that there was no legal basis for the revocation made by the contested decision, that there was no breach of data exclusivity and that general principles of law were infringed.
83      In the first and second parts of the first plea in law, the applicant contests, in essence, the legal basis relied on by the Commission to adopt the contested decision. Those two parts must therefore be addressed jointly.
–       The first and second parts of the first plea in law, alleging, respectively, that there was no legal basis for the revocation made in the contested decision and that there was no breach of data exclusivity
84      By the first part of the first plea in law, the applicant, supported by Biogaran, claims that its MA was valid and based on the most recent scientific evidence, and that the Commission could revoke it only for considerations relating to public health protection, concerning the quality, safety or efficacy of the medicinal product, and not, as is the case here, to protect Biogen’s commercial interests.
85      According to the applicant, the grounds for withdrawal of an
MA are laid down in Articles 20 and 28 of Regulation No 726/2004. Neither the alleged breach of data exclusivity nor marketing protection is mentioned as one of those grounds. In addition, under Article 14(11) of the same regulation, the only data exclusivity policing role conferred on the EMA and the Commission is to ensure that applicants for MAs do not rely on regulatory data of a reference medicinal product which has been authorised for less than eight years.
86      In that regard, first, the applicant claims that the Commission was wrong to adopt measures to comply with the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), which, moreover, caused it to feel obliged to comply also 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). According to the applicant, the decision in the first of those judgments on the plea of illegality regarding recital 3 of the implementing decision of 30 January 2014 did not have an erga omnes effect.
87      Secondly, the applicant submits that Article 266 TFEU cannot be relied on as the legal basis for the contested decision. First of all, Article 81 of Regulation No 726/2004 provides an exhaustive list of the circumstances and conditions to which the revocation of an
MA is subject, which therefore excludes reliance on Article 266 TFEU in that regard. Furthermore, the applicant claims that the Commission did not rely on any provision of Regulation No 726/2004 that could allow the revocation of an
MA on account of a breach of data exclusivity, which has since been restored, even though, under Article 13 of Regulation No 726/2004, an
MA issued in accordance with that regulation is valid throughout the European Union. Next, Article 266 TFEU is not directly applicable because it provides that the institution which adopted the annulled measure is required to take the measures to comply with the judgment, whereas, in the present case, since the Court of Justice did not annul any Commission decision, the Commission is not the appropriate authority to take measures under Article 266 TFEU. Lastly, in the applicant’s submission, even if the Commission were obliged to take 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), the scope of such measures could only be as wide as the scope
of that judgment. According to the applicant, that judgment of the Court of Justice specifically concerned the legality of the implementing decision of 30 January 2014, such that any measure adopted by the Commission that does not fall directly within that scope – including, therefore, the MA for Dimethyl Fumarate Polpharma and its revocation – is not necessary in order to comply with the judgment.
88      Thirdly, the applicant claims that, contrary to what the Commission relied on
in recital 17 of the contested decision, Article 10(2) of Regulation No 726/2004 is not a suitable legal basis for revoking an
MA, as is the case here. Such an article specifically relates to the grant of MAs, whereas the revocation of an
MA is provided for in Article 20(1) of that regulation, in cases where there is a significant change in the risk-benefit assessment of a product. That is not the case here.
89      Fourthly, the applicant claims that the Commission similarly cannot rely on the general principles of EU law to justify the adoption of the contested decision. It is only in the absence of any provision governing the withdrawal or revocation of EU acts that such general principles can be applied, since
the Commission cannot add to or change EU law without taking account of the legislature’s intent.
90      In the second part of the first plea in law, the applicant, supported by Biogaran, submits, first, that the contested decision runs counter to the case-law of the Court of Justice according to which
the legality of an administrative act must be assessed in the light of all the elements of fact and of law that existed when the act was adopted. In the present case, the applicant’s MA is valid because the implementing decision of 13 May 2022 is not illegal, inasmuch as, when the applicant lodged its MA application on 15 June 2021, Tecfidera did not enjoy data exclusivity, as is apparent from the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241). The Commission was therefore wrong to take the view, in the contested decision, that data exclusivity in respect of Tecfidera had been resurrected by 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), and it was thus wrong to repeal the implementing decision of 13 May 2022.
91      Secondly, the applicant claims that, when it submitted its MA application in respect of Dimethyl Fumarate Polpharma, the EMA reviewed that application on the basis of all the clinical data in the Tecfidera dossier. The applicant submits that, while the Court of Justice subsequently held that the General Court had erred in law, the fact remains that the EMA had referred to those clinical data and the ‘fault’ in connection with the approval of its application must therefore be attributed to the EMA. In that regard, the applicant notes that, although the MA application for Dimethyl Fumarate Polpharma was indeed made before 3 February 2022, both the EPAR of 24 February 2022 (see paragraph
22 above) and the implementing decision of 13 May 2022 (see paragraph
24 above) were nevertheless adopted after the end of the eight-year period of Tecfidera data exclusivity. In addition, in the applicant’s submission, even if 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), resurrected the Tecfidera data exclusivity, such
resurrection is irrelevant since data exclusivity can be assessed only during the MA application phase.
92      Thirdly, the applicant submits that, in the light of Article 81(2) of Regulation No 726/2004, an
MA may be revoked only in the circumstances described in Article 28(4) of Regulation No 726/2004, that is to say, following safety concerns. A reinstatement of the data exclusivity period is not mentioned as a ground for revocation.
93      Fourthly, the applicant claims that the right to good administration requires the Commission to adopt decisions according to the procedures and within the time limits provided for by
EU law. While the Commission must comply with strict deadlines during the decision-making process for the grant of an MA, it must also comply with such deadlines in relation to the extension of MAs. In the present case, it follows from the foregoing that the Commission was wrong to adopt Implementing Decision C(2023) 3067 final (see paragraph
29 above), pursuant
to which it adopted the contested decision.
94      The Commission disputes those arguments.
95      In that regard, as a preliminary point, it must be observed that, first, as mentioned in paragraphs
74 to 80 above, the measures to be taken by the Commission and the EMA in the context of complying 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), in accordance with Article 266 TFEU, had to cover inter alia the MA for the applicant’s generic medicinal product (Dimethyl Fumarate Polpharma), since that MA had become illegal in the light of that judgment of the Court of Justice.
96      The view must therefore be taken that, contrary to the applicant’s arguments reproduced in paragraph
86 above, the Commission was right to take 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).
97      Secondly, it must be stated that the question whether, as the applicant claims, the Commission was wrong to take measures to comply with the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), is irrelevant in the context of the present case, because the contested decision did not concern the adoption of measures to comply with that judgment.
98      It must also be pointed out that Article 10 of Regulation No 726/2004 reads as follows:
‘1.      Within 15
days after receipt of the opinion referred to in Article 5(2) [of Regulation No 726/2004], the Commission shall prepare a draft of the decision to be taken in respect of the application.
Where a draft decision envisages the granting of [an
MA], it shall include or make reference to the documents mentioned in points
(a) to (d) of Article 9(4) [of Regulation No 726/2004].
Where a draft decision envisages the granting of [an
MA] subject to the conditions referred to in points
(c), (ca), (cb), or (cc) of Article 9(4) [of Regulation No 726/2004], it shall lay down deadlines for the fulfilment of the conditions, where necessary.
Where the draft decision differs from the opinion of the [EMA], the Commission shall attach a detailed explanation of the reasons for the differences.
The draft decision shall be forwarded to Member States and the applicant.
2.      The Commission shall, by means of implementing acts, take a final decision within 15 days after obtaining the opinion of the Standing Committee on Medicinal Products for Human Use. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 87(2) [of Regulation No 726/2004].
…’
99      Article 20 of Regulation No 726/2004 provides as follows:
‘1.      Where the supervisory authorities or the competent authorities of any other Member State are of the opinion that the manufacturer or importer established within the Union territory is no longer fulfilling the obligations laid down in Title
IV of Directive [2001/83], they shall forthwith inform the [CHMP] and the Commission, stating their reasons in detail and indicating the course of action proposed.
…
2.      The Commission shall request the opinion of the [EMA] within a [time limit] which it shall determine in the light of the urgency of the matter, in order to examine the reasons advanced. Whenever practicable, the holder of the authorisation for placing the medicinal product for human use on the market shall be invited to provide oral or written explanations.
…’
100    Article 28 of Regulation No 726/2009 lays down, inter alia, the stages of the procedure for the Commission to vary, suspend, withdraw or revoke an
MA.
101    Lastly, it must be borne in mind that Article 81 of Regulation No 726/2004 lays down the following:
‘1.      All decisions to grant, refuse, vary, suspend, withdraw or revoke [an
MA] which are taken in accordance with this Regulation shall state in detail the reasons on which they are based. Such decisions shall be notified to the party concerned.
2.      An authorisation to place a medicinal product governed by this Regulation on the market shall not be granted, refused, varied, suspended, withdrawn or revoked except through the procedures and on the grounds set out in this Regulation.’
102    In that regard, according to the case-law, Article 81(1) of Regulation No 726/2004 simply states expressly the general obligation to state reasons laid down in the second paragraph of Article 296 TFEU (see, to that effect, judgment of 19 December 2019, Vanda Pharmaceuticals v Commission, T‑211/18, EU:T:2019:892, paragraph 61 and the case-law cited).
103    Article 81(1) of Regulation No 726/2004 provides, in essence, that all decisions of the Commission in connection with the MA for a medicinal product – including a decision to withdraw or revoke an
MA, such as the contested decision – must state the reasons on which it is based and be notified to the party concerned.
104    In that regard, as a preliminary point, it must be stated that, in recitals 5 to 19 of the contested decision, the Commission stated the reasons for that decision to the requisite legal standard, in particular, first, by explaining the reasons why it was of the view that the implementing decision of 13 May 2022 had become illegal and, secondly, by setting out the reasons why, in its view, Article 10(2) of Regulation No 726/2004 was the proper legal basis for
adopting the contested decision. Furthermore, the compliance with such an obligation to state reasons as regards the contested decision was not disputed by the applicant.
105    In addition, in accordance with Article 81(2) of Regulation No 726/2004, decisions to grant or to withdraw or revoke an
MA must be consistent with the procedural requirements of that regulation and justified by the grounds set out therein.
106    In that regard, it is established that the contested decision was adopted neither under the procedure provided for in Article 20 of Regulation No 726/2004 nor under the procedure
set out in Article 28 of that regulation.
107    First, the contested decision was not adopted on the basis of Article 20(1) of Regulation No 726/2004, that is to say, further to any failure by the applicant to fulfil its obligations in relation to Dimethyl Fumarate Polpharma, laid down in Title
IV of Directive 2001/83, entitled ‘Manufacture and importation’, since
a breach of those obligations was not alleged in that regard. The contested decision was therefore rightly not based on that article.
108    Secondly, nor is it disputed that, since the revocation of the MA for Dimethyl Fumarate Polpharma by the contested decision was not based on safety concerns relating to that medicinal product, the provisions of Chapter
3 of Regulation No 726/2004 on pharmacovigilance, and in particular Article 28 of that regulation, are not relevant in the present case, since a breach of the obligations in question was not alleged. Therefore, the contested decision was also rightly not based on those provisions.
109    It is therefore necessary to examine whether the Commission, notwithstanding Article 81(2) of Regulation No 726/2004, could legitimately rely on Article 10(2) of that regulation to adopt the contested decision.
110    In that regard, as concluded during the analysis of the third and fourth pleas in law (see paragraphs
48 to 81 above), in the light 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), the implementing decision of 30 January 2014 remains valid, with retroactive effect as from the latter date (see paragraph
78 above), including therefore, first, the finding, in recital 3 of that implementing decision, that, in essence, Tecfidera does not belong to the same global MA, within the meaning of the second subparagraph of Article 6(1) of Directive 2001/83, as Fumaderm and, secondly, the fact that the Tecfidera data and the marketing of Tecfidera are protected, in the light of Article 14(11) of Regulation No 726/2004 (see paragraph
79 above).
111    It is for that reason that the measures to be taken by the Commission and the EMA in the context of complying 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), in accordance with Article 266 TFEU, had to cover the MAs for the different generic versions of Tecfidera, including the MA granted to the applicant for Dimethyl Fumarate Polpharma.
112    In addition, when the contested decision was adopted, that is to say, on 13 December 2023, the protection period laid down in Article 14(11) of Regulation No 726/2004 for the marketing of Tecfidera had not yet expired and ran until 2 February 2025 (see paragraph
29 above). Accordingly, an essential pre-requisite for the validity of the MA of Dimethyl Fumarate Polpharma had ceased to exist following 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).
113    In order to comply, in accordance with Article 266 TFEU, 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), and thereby to ensure observance of Tecfidera’s right to marketing protection, pursuant to Article 14(11) of Regulation No 726/2004, the Commission was therefore obliged to revoke the MA for Dimethyl Fumarate Polpharma because it followed from that judgment that that MA had been granted in breach of Tecfidera’s right to marketing protection and that it was therefore illegal.
114    In that regard, it must be borne in mind that Article 10(2) of Regulation No 726/2004 provides that, within 15 days after obtaining the opinion of the Standing Committee on Medicinal Products for Human Use (‘the SCHMP’), established by Article 121(1) of Directive 2001/83 and referred to in Article 87(1) of Regulation No 726/2004, the Commission is, by means of implementing acts, to take a final decision, in accordance with the examination procedure referred to in Article 87(2) of the same regulation. It is on the basis of the latter provision that the MA for Dimethyl Fumarate Polpharma was granted to the applicant by the implementing decision of 13 May 2022.
115    It follows from the case-law that there is a general principle of law that, in principle, a body which has power to adopt a particular legal measure also has power to abrogate or amend it by adopting an actus contrarius, unless such power is expressly conferred upon another body (see, to that effect, judgment of 20 November 2002, Lagardère and Canal+ v Commission, T‑251/00, EU:T:2002:278, paragraph 130).
116    It is for that reason that the Commission stated, in recital 17 of the contested decision, that, whilst it is empowered pursuant to Article 10(2) of Regulation No 726/2004 to grant an
MA for a medicinal product where all the requirements provided for in the legislation for granting such authorisation are fulfilled, the Commission is equally empowered, on the same legal basis, to withdraw the decision if it finds
that it has become unlawful.
117    On the basis of Article 10(2) of Regulation No 726/2004, and relying on the general legal principle mentioned in paragraph
115 above, the Commission could therefore legitimately revoke, as it did in the contested decision, the MA which it had granted to the applicant for Dimethyl Fumarate Polpharma.
118    Lastly, contrary to what the applicant claims, nor did the revocation, by the contested decision, of the MA which the Commission had granted to it for Dimethyl Fumarate Polpharma infringe Article 13 of Regulation No 726/2004.
119    Article 13 of Regulation No 726/2004 provides that an
MA which has been granted in accordance with that regulation is to be valid throughout the European Union and confer the same rights and obligations in each of the Member States as an
MA granted by that Member State. However, that provision requires, as a precondition, that the MA in question was granted legitimately, which was not the case here, as concluded in paragraphs
80 and 113 above.
120    The first and second parts of the first plea in law must therefore be rejected.
–       The third part of the first plea in law
121    In a third part, the applicant, supported by Biogaran, claims that, according to the case-law of the Court of Justice, EU institutions are only entitled to withdraw unlawful acts, subject to the double condition that the legitimate expectations of the person concerned are respected and that the withdrawal takes place within a reasonable period. In the applicant’s submission, neither of those conditions is fulfilled in the present case.
122    First, the applicant submits that the implementing decision of 13 May 2022 is not unlawful since
there was no data exclusivity in respect of Tecfidera at the time of the filing of the MA in question on 15 June 2021.
123    Secondly, the applicant claims that there was a breach of its legitimate expectations in the lawfulness of the implementing decision of 13 May 2022, which was revoked by the contested decision. In that regard, the applicant argues that the EMA validated the applicant’s application for Dimethyl Fumarate Polpharma without any reservation. Furthermore, according to the applicant, any reservations that may have been contained in the report of 11 November 2021, with respect to the appeal proceedings before the Court of Justice, do not appear in the implementing decision of 13 May 2022, which therefore created a legitimate expectation on the part of the applicant that it could proceed to market Dimethyl Fumarate Polpharma, regardless of the appeal pending before the Court of Justice. In that regard, the applicant stresses the fact that, in concluding in the report of 11 November 2021 that it was impossible to establish that MEF exerted a clinically relevant therapeutic contribution within Fumaderm, the CHMP relied not only on the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), but also on scientific conclusions. In any event, the bringing of an action for annulment before the Court of Justice does not call into question the presumption of the legality of an act of an EU institution.
124    Thirdly, the applicant claims that it relied for almost a year and a half on the unconditional MA which had been granted to it for Dimethyl Fumarate Polpharma, and that it therefore, over that period, engaged in numerous efforts to market that medicinal product. It is therefore unreasonable to withdraw the MA for Dimethyl Fumarate Polpharma, especially since that authorisation was withdrawn more than nine months after 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). According to the applicant, a transition period should at the very least have been granted, for example until the grant of a new MA.
125    In addition, the applicant submits that the starting point for calculating whether the period in which the contested decision was adopted was a reasonable period is not 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), but rather the Commission’s decision to grant it an
MA, namely 13 May 2022.
126    The Commission disputes those arguments.
127    In that regard, according to settled case-law, while it must be acknowledged that any EU institution which establishes that a measure which it has just adopted is tainted with illegality has the right to withdraw it within a reasonable period, with retroactive effect, that right may be restricted by the need to fulfil the legitimate expectations of a beneficiary of the measure, who has been led to rely on the lawfulness thereof (see judgment of 20 June 1991, Cargill v Commission, C‑248/89, EU:C:1991:264, paragraph 20 and the case-law cited).
128    The withdrawal of an unlawful act which has benefited its recipient is therefore subject to two legal conditions, the first being that it respects the legitimate expectations of the person concerned, and the second that it takes place within a reasonable period (judgment of 12 February 2020, ZF v Commission, T‑605/18, EU:T:2020:51, paragraph 150).
129    In the first place, as a preliminary point, it must be stated that, as concluded in paragraph
113 above, the act revoked by the contested decision, that is to say, the implementing decision of 13 May 2022, which granted the applicant the MA for Dimethyl Fumarate Polpharma, is an unlawful act. It follows 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), that that MA was granted in breach of Tecfidera’s right to marketing protection, in accordance with Article 14(11) of Regulation No 726/2004 and that, therefore, the Commission was obliged to revoke that MA.
130    In the second place, with regard to respect for the legitimate expectations of the person concerned, it is settled case-law that the right to rely on the principle of the protection of legitimate expectations presupposes the fulfilment of three cumulative conditions. First, precise, unconditional and consistent assurances originating from authorised and reliable sources must have been given to the person concerned by the administration. Secondly, those assurances must be such as to give rise to a legitimate expectation on the part of the person to whom they are addressed. Thirdly, the assurances given must comply with the applicable rules (see judgment of 12 February 2020, ZF v Commission, T‑605/18, EU:T:2020:51, paragraph 151 and the case-law cited).
131    In the present case, first, it must be borne in mind that it was in order to comply with the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), that the Commission granted the applicant, by the implementing decision of 13 May 2022, the MA for Dimethyl Fumarate Polpharma, in respect of which it relied, inter alia, on the EPAR of 24 February 2022 and on the opinion of the CHMP of the same date. As mentioned in the EPAR and in the opinion in question (see paragraphs 22 and 23 above), the position of the CHMP and of the EMA was without prejudice to the outcome of the appeal proceedings brought against the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241).
132    Secondly, the report of 11 November 2021 also states that it was drawn up in compliance with the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241) (see paragraph 19 above).
133    It follows that, when the implementing decision of 13 May 2022 was adopted, the applicant could not have been unaware that the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), had been the subject of appeals and that, therefore, there was a risk of it being set aside and, consequently, of the MA for Dimethyl Fumarate Polpharma being revoked.
134    Thirdly, it should be recalled that, on 17 May 2022, Biogen brought an action for annulment, based on Article 263 TFEU, against the implementing decision of 13 May 2022 (see paragraph
26 above). The applicant could not therefore have been unaware that the MA for Dimethyl Fumarate Polpharma might also be revoked in the context of that action.
135    The grant of the MA for Dimethyl Fumarate Polpharma, by the implementing decision of 13 May 2022, could not therefore give rise to a legitimate expectation on the part of the applicant that the validity of that implementing decision would not be called into question, in particular by the Court of Justice in the context of the appeals which had been brought against the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241). Furthermore, it must be stated that the Commission did not have the power to give assurances as to the validity of the implementing decision, since it could not foresee the outcome of such appeals before the Court of Justice, which were pending when that implementing decision was adopted.
136    It follows that, in the present case, the existence of a legitimate expectation is not established.
137    In the third place, as regards compliance with the reasonable period requirement, it must be borne in mind that, pursuant to the right to good administration, enshrined in Article 41 of the Charter of Fundamental Rights of the European Union (‘the Charter’), every person has the right to have his or her affairs handled impartially, fairly and within a reasonable time by the institutions, bodies, offices and agencies of the European Union. In that regard, the case-law has clarified that it fell to the administration to examine all the relevant particulars of a case with care and impartiality and gather all the factual and legal information necessary to exercise its discretion and to ensure the proper conduct and effectiveness of proceedings which it sets in motion (see judgment of 30 January 2018, Przedsiębiorstwo Energetyki Cieplnej v ECHA, T‑625/16, not published, EU:T:2018:44, paragraph 89 and the case-law cited).
138    In addition, whether a period is reasonable must be assessed on the basis of all the circumstances of the case (see judgment of 12 February 2020, ZF v Commission, T‑605/18, EU:T:2020:51, paragraph 159 and the case-law cited).
139    In the present case, as a preliminary point, it must be recalled that, as concluded in paragraph
113 above, following 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), the implementing decision of 13 May 2022 is an unlawful act. Therefore, further to that judgment, the Commission was obliged to revoke the MA for Dimethyl Fumarate Polpharma, granted by that implementing decision. The argument, reproduced in paragraph
125 above, that the correct starting point for calculating whether the period within which the contested decision was adopted was a reasonable period is 13 May 2022 must therefore be rejected. It follows that it is necessary to consider the period running from 16 March to 13 December 2023, that is to say, a period of 8
months and 27 days.
140    In that regard, first, it must be stated that, on 17 March 2023, that is to say, the day after the delivery 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), the Commission sent a letter to the applicant in which the Commission inter alia set out its position on the consequences of the judgment of the Court of Justice as regards Tecfidera’s right to data protection and the period (which was still running as at that date) of marketing protection for that reference medicinal product. In that letter, the Commission asked the applicant to act in accordance with the duration of that marketing protection period for Tecfidera, inter alia by providing it with a written commitment to that effect. In addition, the Commission reserved its right to take any further regulatory action on the basis of that judgment of the Court of Justice (see paragraph
28 above).
141    Secondly, as follows from recital 20 of the contested decision, the SCHMP was consulted on the draft implementing decision in question, but did not deliver an opinion within the time limit laid down by the Chair of that committee; the draft was subsequently submitted to the appeal committee for further deliberation. The appeal committee has likewise not delivered an opinion.
142    Thirdly, as mentioned in recital 21 of the contested decision, and as the Commission has argued without being challenged by the applicant, the applicant was informed of the proposal to revoke the implementing decision of 13 May 2022 and was invited to submit observations.
143    Therefore, during the period mentioned in paragraph
139 above, not only did the Commission warn the applicant in writing, exercising due diligence, as early as the day after the delivery 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), of the need to comply with the marketing protection period for Tecfidera and the fact that measures could be adopted in that regard, but also, above all, the Commission had to comply with the procedural requirements laid down in Article 10(2) of Regulation No 726/2004, applicable to the adoption of the contested decision, a fact which, moreover, the applicant does not call into question.
144    In that regard, it must be borne in mind that the Commission had to submit the contested decision to the SCHMP and to the appeal committee (see paragraph
141 above). The Commission also gave the applicant the opportunity to submit its observations on the proposal to revoke the implementing decision of 13 May 2022 (see paragraph
142 above).
145    It follows that, in the circumstances of the present case, and in the light of the case-law cited in paragraph
137 above, the 8
months and 27 days which the Commission took, following 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), to adopt the contested decision can be regarded as constituting a reasonable period.
146    It follows from the foregoing that a breach of the rules on the withdrawal of illegal acts is not established here.
147    The third part of the first plea in law must therefore be rejected.
148    Accordingly, the first plea must be rejected.
The second plea in law
149    In the second plea in law, the applicant submits that the Commission misused its powers when it adopted the contested decision.
150    The applicant submits that it is for the holder of the MA,
in the present case, Biogen, and not the Commission to enforce compliance with the marketing protection period arising from that MA. There is no legal basis under EU law that allows the Commission
to revoke the applicant’s MA for Dimethyl Fumarate Polpharma and, thus, to force
the applicant to comply with the marketing protection period for Tecfidera alleged by Biogen.
151    In addition, with respect to data exclusivity, it follows from Article 14(11) of Regulation No 726/2004 that the only marketing exclusivity role played by the EMA and the Commission is to ensure that applicants for MAs do not rely on the regulatory data of a reference medicinal product authorised for less than eight years. However, that role ends as soon as the MA is granted. The Commission does not have the power to intervene in a commercial dispute between private entities, such as the applicant and Biogen, and should therefore have awaited the outcome of Biogen’s appeal, by which it had challenged the validity of the MA for Dimethyl Fumarate Polpharma, which it did not do.
152    The Commission, supported by Biogen, disputes those arguments.
153    In that regard, it is apparent from settled case-law that the concept of a ‘misuse of powers’ refers to cases where an administrative authority has used its powers for a purpose other than that for which they were conferred on it. A decision may amount to a misuse of powers only if it appears, on the basis of objective, relevant and consistent evidence, to have been taken for purposes other than those stated (see judgment of 14 December 2011, Nycomed Danmark v EMA, T‑52/09, EU:T:2011:738, paragraph 103 and the case-law cited).
154    In that regard, it must be recalled that, as concluded in paragraph
113 above, the implementing decision of 13 May 2022 is an unlawful act. The MA for Dimethyl Fumarate Polpharma had been granted in breach of Tecfidera’s right to marketing protection, in accordance with Article 14(11) of Regulation No 726/2004. The Commission was therefore obliged to revoke that MA.
155    In addition, as concluded in paragraph
117 above, the Commission could legitimately, on the basis of Article 10(2) of Regulation No 726/2004 and relying on the general legal principle mentioned in paragraph
115 above, revoke the contested decision.
156    It follows that, regardless of the fact that Biogen, as the holder of the MA for Tecfidera, had brought an action to challenge the validity of the implementing decision of 13 May 2022 and irrespective of the existence of a dispute between the applicant and Biogen, the Commission was obliged to adopt the contested decision in order to comply, in accordance with Article 266 TFEU, 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), and thus to enforce compliance with Tecfidera’s right to the marketing protection period, in accordance with Article 14(11) of Regulation No 726/2004.
157    The Commission did not therefore misuse its powers when it adopted the contested decision.
158    The second plea in law must therefore be rejected.
The fifth plea in law
159    In the fifth plea in law, the applicant submits that the MA for Tecfidera, granted to Biogen by the implementing decision of 30 January 2014, is unlawful and should therefore be declared inapplicable, thus depriving the Commission of any basis to adopt subsequent measures with regard to
the applicant, including therefore the contested decision.
160    First, the applicant claims that the scientific evidence contained in the report of 11 November 2021, which indicate that Fumaderm and Tecfidera belong to the same global MA, cannot be ignored. In that regard, the applicant argues that, although, 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), the Court of Justice rejected the plea of illegality raised against the implementing decision of 30 January 2014, the facts at issue in the case which gave rise to that judgment are not the same as those at issue in the present case, since, unlike the situation before the General Court in the present case, the Court of Justice could not, in that judgment, take account of the report of 11 November 2021.
161    Secondly, the applicant claims that, if the Commission wanted to maintain a strict interpretation that it could not further investigate the therapeutic contribution of MEF within Fumaderm, that
would also mean that, on 18 September 2013 (see paragraph
7 above), it unlawfully requested the CHMP to assess whether, contrary to the findings of the opinion of 21 March 2013 (see paragraph
6 above), DMF was different to Fumaderm. According to the applicant, it was only because of that request and the new evidence submitted by Biogen that the new active substance status was granted to DMF within Tecfidera (see paragraph
8 above). The applicant submits that, following the same logic, the only decision to be taken into account concerning the marketing protection for Tecfidera is the opinion of 21 March 2013, in which the view
was taken
that Tecfidera could not enjoy new marketing protection because, based on the submitted data, its properties did not appear to differ significantly from those of Fumaderm.
162    Thirdly, the applicant submits that the CHMP assessment relating to Tecfidera, in the opinion of 21 November 2013, contains contradictions, given the new evidence arising from the report of 11 November 2021, which could not be taken into account by 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).
163    The Commission, supported by Biogen, disputes those arguments.
164    In that regard, as a preliminary point, it must be stated that the opinion of 21 March 2013 is a preparatory document in the MA procedure for Tecfidera. During that procedure, a request for review of an initial opinion of the CHMP could be submitted, a fact which moreover the applicant does not contest. It was following such a request for review of the opinion of 21 March 2013 that the opinion of 21 November 2013 was provided.
165    Therefore, contrary to what the applicant claims, and as the Commission rightly argues, the opinion of 21 November 2013 is the final scientific opinion, the legality of which is not, moreover, contested by the applicant. That opinion is therefore the only one that reflects the CHMP’s position concerning the MA application
for Tecfidera, and it is the opinion upon which the Commission correctly relied in adopting the implementing decision of 30 January 2014.
166    In addition, as follows from the analysis carried out in connection with the third and fourth pleas in law, the therapeutic effect of MEF within Fumaderm, a factor addressed in the assessment carried out in the report of 11 November 2021, was regarded by 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), as not being a necessary criterion to determine whether Tecfidera and Fumaderm belonged to the same global MA within the meaning of the second subparagraph of Article 6(1) of Directive 2001/83. The Court of Justice took the view that the test applied in the implementing decision of 30 January 2014, following the opinion of 21 November 2013, to conclude that Tecfidera and Fumaderm did not belong to the same global MA was sufficient (see paragraphs
69 and 71 above).
167    It follows that the findings arising from the report of 11 November 2021 have no bearing on the legality of the implementing decision of 30 January 2014, which therefore remains valid.
168    Accordingly, the fifth plea in law must be rejected.
The sixth plea in law
169    In the sixth plea in law, the applicant submits, in essence, that, during the procedure which led to the adoption of the contested decision, the Commission infringed the applicant’s right to be heard, the right to good administration and essential procedural requirements.
170    First, the applicant claims that, following 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), the Commission unilaterally moved forward with regulatory actions. The Commission did not hear the applicant during the procedure for adoption of the contested decision. In addition, under the fourth subparagraph of Article 10(1) of Regulation No 726/2004, the Commission was obliged to consult the CHMP in the present case, in accordance with Article 5(2) of that regulation.
171    Secondly, the applicant claims that, in accordance with Article 41 of the Charter, which guarantees the right to good administration, the Commission should have provided detailed reasons explaining why it considered the report of 11 November 2021 to be no longer relevant, since
simply referring to 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), was insufficient. Such an obligation is consistent with the fourth subparagraph of Article 10(1) of Regulation No 726/2004. That is why the applicant submits that, if it intended to revoke the applicant’s MA, the Commission should have asked the CHMP to draw up a new report, thereby departing from the scientific opinions that existed when the contested decision was adopted, that is to say, the report of 11 November 2021, the CHMP’s opinion of 27 January 2022, the opinion of 24 February 2022 and a CHMP report of 22 April 2022, by which the CHMP confirmed its opinion of 27 January 2022, in particular as far as concerned its finding that a clinically relevant therapeutic contribution of MEF within Fumaderm had not been demonstrated.
172    Thirdly, the Commission never heard the applicant as regards a possible revocation of the latter’s MA for Dimethyl Fumarate Polpharma. According to the applicant, contrary to what is stated in recital 21 of the contested decision, it was not informed of the proposal to revoke the implementing decision of 13 May 2022 and was therefore not invited to submit observations in that regard. The applicant adds that only at a very late stage of the procedure for adoption of the contested decision, specifically by a letter of 27 September 2023, was it invited to submit observations on the legal basis for the revocation of its MA for Dimethyl Fumarate Polpharma within a period of 10
working days, whereas the Commission had been deliberating on that matter for months. According to the applicant, the sole purpose of such a belated invitation from the Commission was to create the appearance of it respecting the applicant’s right to be heard.
173    In addition, the applicant claims that, after learning the outcome of the vote within the appeal committee as part of the procedure for adoption of the contested decision, on 8 December 2023 it requested a meeting with the Commission. The Commission responded simply by a letter of 13 December 2023 stating that it had started the process to adopt the contested decision. However, following the notification of the contested decision, on 13 December 2023, and a new request for a meeting, made the following day, the Commission finally agreed to a meeting with the applicant on 15 December 2023. Such a change of approach demonstrates, in the applicant’s submission, that, up until the revocation of the MA for Dimethyl Fumarate Polpharma, the Commission used delaying tactics to avoid hearing the applicant.
174    Fourthly, the applicant submits that the Commission reserved preferential treatment for Biogen, which consisted inter alia in informing the latter of the outcome of the written consultation of the SCHMP as part of the procedure that led to the adoption of the contested decision, which raises questions about the transparency and fairness of the procedure. The applicant also claims that the Commission failed to respond to a letter sent to it by the applicant on 15 November 2023 concerning the outcome of that written consultation.
175    Fifthly, the applicant claims that a request for access to documents, submitted on 19 April 2023, received a late response in December of that same year granting partial access.
176    The Commission disputes those arguments.
177    In that regard, as a preliminary point, it must be recalled that, according to settled case-law, the right to be heard in all proceedings is affirmed in Article 41 of the Charter, which guarantees the right to good administration. Article 41(2) of the Charter provides that that right to good administration includes, inter alia, the right of every person to be heard before any individual measure which would affect him or her adversely is taken (see judgment of 26 January 2022, Mylan IRE Healthcare v Commission, T‑303/16, not published, EU:T:2022:25, paragraph 165 and the case-law cited).
178    Respect for the right to be heard is, in all proceedings which are liable to culminate in a measure adversely affecting a person, a fundamental principle of EU law which must be guaranteed even in the absence of rules governing the proceedings in question. That principle requires that the addressees of decisions which significantly affect their interests should be placed in a position in which they can effectively make known their views on the accusation made against them forming the basis of the contested measure (see judgment of 26 January 2022, Mylan IRE Healthcare v Commission, T‑303/16, not published, EU:T:2022:25, paragraph 166 and the case-law cited).
179    First, as regards the applicant’s argument that the Commission heard the applicant about a possible revocation of its MA for Dimethyl Fumarate Polpharma only at a very late stage of the procedure (see paragraph
172 above), it must be stated that, by a letter of 27 September 2023, the Commission informed the applicant of its intention to revoke the implementing decision of 13 May 2022 and invited the applicant to submit observations in that regard within 10
days. In response to that letter, the applicant submitted its observations on 6 October 2023.
180    It follows that, contrary to what the applicant claims, it cannot be alleged that the Commission heard the applicant at a late stage of the procedure, since, as the applicant itself acknowledges, it was able to make known its point of view more than two months before the contested decision was adopted.
181    That argument must thus be rejected.
182    Secondly, as regards the applicant’s argument that it submitted, on 19 April 2023, a request for access to documents which received only a late response and was granted in part in December of that same year, suffice it to state that the applicant fails to demonstrate how such an argument, even if proven, would have affected the validity of the contested decision. Furthermore, as the Commission has argued without being challenged by the applicant, such a request was dealt with in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43). The claims made by the applicant in that regard that the Commission thus infringed its right to be heard must therefore be rejected.
183    Thirdly, as regards the applicant’s arguments alleging infringement of essential procedural requirements, it must be recalled that Article 5(2) of Regulation No 726/2004 provides that ‘the [CHMP] shall be responsible for drawing up the opinion of the [EMA] on any matter concerning the admissibility of the files submitted in accordance with the centralised procedure, the granting, variation, suspension or revocation of an authorisation to place a medicinal product for human use on the market in accordance with the provisions of this Title, and pharmacovigilance’.
184    In addition, Article 57(1) of Regulation No 726/2004 provides that the EMA is to provide the Member States and the institutions of the European Union with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human use which is referred to it in accordance with the EU
legislation relating to medicinal products for human use. In that regard, Article 57(1)(a) and (p) of Regulation No 726/2004 provides inter alia that it is for the EMA, first, to coordinate the scientific evaluation of the quality, safety and efficacy of medicinal products for human use which are subject to EU
MA procedures and, secondly, at the Commission’s request, to draw up any other scientific opinion concerning the evaluation of medicinal products for human use or the starting materials used in the manufacture of medicinal products for human use.
185    It follows that an opinion of the CHMP is mandatory, on the basis of Article 5(2) of Regulation No 726/2004, for the adoption of a decision to withdraw an
MA for a medicinal product, where such a withdrawal is based on objective and new scientific or medical data. In such cases, the Commission is required, in the context of an adversarial and transparent procedure, to rely on CHMP reports and scientific experts’ reports in order to adopt such a decision, on the basis of the most recent scientific data.
186    However, in the present case, the withdrawal of the MA for Dimethyl Fumarate Polpharma by the contested decision is not based on new scientific or medical data with respect to that medicinal product. As concluded in paragraphs
107 and 108 above, the Commission was correct not to decide upon such a withdrawal
on the basis of Article 20(1) of Regulation No 726/2004 or on the basis of the provisions of Chapter
3 of that regulation concerning pharmacovigilance, in particular Article 28
thereof.
187    However, as concluded in paragraph
117 above, the Commission could legitimately adopt the contested decision by relying on Article 10(2) of Regulation No 726/2004 and on the general legal principle mentioned in paragraph
115 above.
188    In addition, it must be recalled that, as concluded in paragraph
78 above, further to 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), the implementing decision of 30 January 2014 remained valid. Accordingly, the procedure which had led to the adoption of that implementing decision also remained valid, including the CHMP opinion that preceded it, namely the opinion of 21 November 2013. Thus, the Commission was not obliged to request a new opinion from the CHMP in the context of the procedure which led to the adoption of the contested decision. As concluded in paragraph
73 above, the scientific evaluation contained in the opinion of 21 November 2013 was sufficient to assess whether or not Fumaderm and Tecfidera belonged to the same global MA, within the meaning of Article 6(1) of Directive 2001/83.
189    It follows that, as the Commission rightly contends, in the present case, it was not necessary to consult the CHMP in accordance with Article 5(2) of Regulation No 726/2004 and that, therefore, the fourth subparagraph of Article 10(1) of that regulation is not relevant here.
190    The arguments alleging infringement, by the Commission, of Article 5(2) and of the fourth subparagraph of Article 10(1) of Regulation No 726/2004 must therefore
be rejected.
191    Fourthly, as regards the applicant’s claims that the Commission reserved preferential treatment for Biogen (see paragraph
174 above), it must be stated that such claims are unsubstantiated. In any event, even if they were proven, the applicant fails to demonstrate how the fact that the Commission informed Biogen of the outcome of the SCHMP’s written consultation, in the context of the procedure that led to the adoption of the contested decision, infringed the applicant’s right to be heard. Those allegations must therefore be rejected.
192    It follows that the sixth plea in law must be rejected.
The seventh plea in law
193    By the seventh plea in law, the applicant claims that, in accordance with the principle of legal certainty, only illegal
decisions can be withdrawn, whereas the Commission has failed to adduce any argument capable of corroborating the fact that, when it was adopted, the implementing decision of 13 May 2022, which was revoked by the contested decision, was illegal.
194    The applicant also claims that, contrary to the view taken by the Commission, the unlawfulness of the implementing decision of 13 May 2022 does not follow 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), since that judgment concerned a different MA. Furthermore, according to the applicant, in that judgment, the Court of Justice did not address the legality of its MA or the new evaluation by the CHMP in the report of 11 November 2021, which demonstrates that MEF within Fumaderm has no clinical relevance. Nor did the Court of Justice find that the CHMP was not authorised to make such a reassessment or that the Commission could not take it into account when examining the applicant’s MA application.
195    The Commission disputes those arguments.
196    In that
regard, it must be observed that the seventh plea in law is based on the same considerations as those forming the basis of the third and fourth pleas in law and, moreover, of the second part of the first plea in law, all of which have been rejected.
197    In the first place, it must be borne in mind, as found in paragraphs
65 to 71 above, that, 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), the Court of Justice considered that the evaluation carried out in the opinion of 21 November 2013, which had preceded the adoption of the implementing decision of 30 January 2014, had allowed the CHMP to find that Fumaderm, composed of DMF and MEF, and Tecfidera, composed of DMF as a mono-substance, were different, since DMF and MEF did not have the same therapeutic moiety and did not therefore correspond to the same active substance. According to the Court of Justice, such an evaluation was sufficient to assess whether or not Fumaderm and Tecfidera belonged to the same global MA, within the meaning of Article 6(1) of Directive 2001/83.
198    The Commission was therefore right to take the view that the report of 11 November 2021 had carried out an evaluation that was not necessary to assess whether or not Fumaderm and Tecfidera belonged to the same global MA, within the meaning of Article 6(1) of Directive 2001/83, since
the evaluation conducted in the opinion of 21 November 2013 was sufficient in that regard (see paragraph
73 above).
199    In the second place, it must be borne in mind, as concluded in paragraphs
78 to 80 above, that it follows 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), that the implementing decision of 30 January 2014 remains valid in its entirety and that, therefore, the measures to be adopted by the Commission and the EMA in the context of complying with that judgment, in accordance with Article 266 TFEU, had to cover inter alia the MA granted to the applicant for Dimethyl Fumarate Polpharma, since that MA had become unlawful in the light of the judgment of the Court of Justice.
200    In that regard, it must be recalled that, as concluded in paragraph
113 above, contrary to what the applicant claims, the act revoked by the contested decision, that is to say, the implementing decision of 13 May 2022, is an unlawful act, for the reasons stated in that paragraph, and that, therefore, the Commission was obliged to revoke it.
201    It follows that the applicant’s arguments regarding the Commission’s breach of the principle of legal certainty must be rejected.
202    In those circumstances, the seventh plea in law must be rejected.
The eighth plea in law
203    In the eighth plea in law, the applicant submits that the contested decision infringed the principle of the protection of legitimate expectations. It maintains
that it was justified in having confidence, as it had, moreover, for two years, in the apparent legality of the measure granting it an unconditional MA, the MA which the Commission revoked by the contested decision. According to the applicant, the Commission had the opportunity to deviate from the CHMP opinions, that is to say, the report of 11 November 2021, the CHMP opinion of 27 January 2022, the opinion of 24 February 2022 and the report of 22 April 2022, but chose not to do so and, instead, granted it an unconditional MA.
204    In addition, the applicant also claims that, following the report of 11 November 2021, it could legitimately be expected that Biogen would update its MA for Fumaderm, in accordance with Article 16(2) and Article 17 of Regulation No 726/2004, but it failed to do so. The applicant submits that, at the very least, there was a legitimate expectation that the BfArM would amend the MA for Fumaderm, pursuant to Article 116 of Directive 2001/83. According to the applicant, with such updates, the regulatory landscape corresponded to the state of the scientific evidence and, consequently, Tecfidera and Fumaderm belonged to the same global MA within the meaning of Article 6(1) of Directive 2001/83, both from a substantive and a formal perspective.
205    The Commission disputes those arguments.
206    In that regard, it must be stated that the eighth plea in law is based, in essence, on considerations which also form the basis of the third part of the first plea in law, which has been rejected (see paragraphs
121 to 147 above).
207    In addition, any obligation on Biogen, following the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), to update its MA for Fumaderm, in accordance with Article 16(2) and Article 17 of Regulation No 726/2004, as the applicant claims, is irrelevant in the context of the present case.
208    Even assuming that Biogen should have requested an update of its MA for Fumaderm, that would have been, in any event, without prejudice to the outcome of the appeals which had been brought against the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241). Accordingly, any such update could not have called into question the finding, referred to in paragraph
135 above, that the grant of the MA for Dimethyl Fumarate Polpharma, by the implementing decision of 13 May 2022, could not give rise to a legitimate expectation on the part of the applicant that the validity of that implementing decision would not be called into question by the Court of Justice in the context of those appeals.
209    It follows that, as concluded in paragraph
136 above, the applicant’s arguments concerning the Commission’s breach of the principle of the protection of legitimate expectations must be rejected.
210    The eighth plea in law must therefore be rejected.
The ninth plea in law
211    In the ninth plea in law, the applicant claims that the contested decision infringes its right to property, enshrined in Article 17 of the Charter, and the principle of proportionality. The applicant submits that the Commission fails to show, first of all, that there is a legitimate overriding objective that justifies depriving the applicant of its unconditional MA for Dimethyl Fumarate Polpharma; next, that the contested decision represents the least restrictive means to achieve that legitimate objective; and, lastly, that that decision is proportionate to the damage caused. In addition, the Commission did not provide compensation for the losses suffered by the applicant.
212    Moreover, according to the applicant, if the Commission wanted to make good the alleged harm caused to the holder of the MA for the reference medicinal product,
in the present case, Biogen, the Commission could have provided monetary compensation to Biogen.
213    The Commission disputes those arguments.
214    In that regard, Article 17(1) of the Charter provides:
‘Everyone has the right to own, use, dispose of and bequeath his or her lawfully acquired possessions No one may be deprived of his or her possessions, except in the public interest and in the cases and under the conditions provided for by law, subject to fair compensation being paid in good time for their loss. The use of property may be regulated by law in so far as is necessary for the general interest.’
215    In addition, under Article 52(1) of the Charter, first, ‘any limitation on the exercise of the rights and freedoms recognised by [the] Charter must be provided for by law and respect the essence of those rights and freedoms’ and, secondly, ‘subject to the principle of proportionality, limitations may be made only if they are necessary and genuinely meet objectives of general interest recognised by the Union or the need to protect the rights and freedoms of others’.
216    In the present case, it must be recalled that, as concluded in paragraph
113 above, the act revoked by the contested decision, that is to say, the implementing decision of 13 May 2022, which granted to the applicant the MA for Dimethyl Fumarate Polpharma, is an unlawful act.
217    It follows that the rights arising from the MA for Dimethyl Fumarate Polpharma, even assuming that they are covered by Article 17 of the Charter, cannot be regarded as having been lawfully acquired within the meaning of paragraph 1 of that article.
218    Therefore, the contested decision cannot be regarded as a limitation on the rights enjoyed by the applicant under Article 17 of the Charter (see, to that effect and by analogy, judgment of 12 December 2024, Nemzeti Földügyi Központ, C‑419/23, EU:C:2024:1016, paragraphs 72 to 76).
219    It follows that the applicant’s arguments regarding the alleged breach of the principle of proportionality, which are linked to the arguments relating to the alleged breach of the right to property, cannot succeed.
220    The arguments concerning the Commission’s infringement of the applicant’s right to property and of the principle of proportionality must therefore
be rejected.
221    The ninth plea in law must therefore be rejected.
222    Since the nine pleas in law relied on by the applicant in support of its action have been rejected, that action must be dismissed.
Costs
223    Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.
224    Since the applicant has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by the Commission and by Biogen, in accordance with the forms of order sought by them, including those relating to the proceedings for interim measures.
225    Pursuant to Article 138(3) of the Rules of Procedure, Biogaran is to bear its own costs.
On those grounds,
THE GENERAL COURT (Fourth Chamber)
hereby:
1.      Dismisses the action;
2.      Orders Zakłady Farmaceutyczne Polpharma S.A. to pay the costs, including those relating to the proceedings for interim measures;
3.      Orders Biogaran to bear its own costs.
da Silva Passos
Reine
Pynnä
Delivered in open court in Luxembourg on 11 February 2026.
V. Di Bucci
S. Papasavvas
Registrar
President
*      Language of the case: English.