JUDGMENT OF THE GENERAL COURT (Fourth Chamber)
24 September 2025 (*)
( Medicinal products for human use – Variation of the marketing authorisation for Tecfidera – Dimethyl fumarate, a medicinal product for human use – Directive 2001/83/EC – Article 14(11) of Regulation (EC) No 726/2004 – Article 266 TFEU )
In Case T‑278/23,
Zentiva k.s., established in Prague (Czech Republic),
Zentiva Pharma GmbH, established in Frankfurt am Main (Germany),
represented by K. Roox, T. De Meese, J. Stuyck and C. Dumont, lawyers,
applicants,
v
European Commission, represented by L. Haasbeek, E. Mathieu and A. Spina, acting as Agents,
defendant,
supported by
Biogen Netherlands BV, established in Amsterdam (Netherlands), represented by C. Schoonderbeek and B. Jong, lawyers,
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: V. Di Bucci,
having regard to the order of 2 February 2024, Zentiva and Zentiva Pharma v Commission (C‑609/23 P(R), not published, EU:C:2024:114),
having regard to the written part of the procedure, including the applicants’ new evidence lodged at the Registry of the General Court on 15 November 2024,
having regard to the fact that no request for a hearing was submitted by the parties within three weeks after service of notification of the close of the written part of the procedure, and having decided to rule on the action without an oral part of the procedure, pursuant to Article 106(3) of the Rules of Procedure of the General Court,
gives the following
Judgment
1        By their action under Article 263 TFEU, the applicants, Zentiva k.s. and Zentiva Pharma GmbH, seek the annulment of Commission Implementing Decision C(2023) 3067 (final) of 2 May 2023 amending the marketing authorisation granted by Decision C(2014) 601 (final) for ‘Tecfidera – Dimethyl fumarate’, a medicinal product for human use (‘the contested decision’).
Background to the dispute
2        The applicants are pharmaceutical companies that develop and market 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) granted Fumapharm AG two marketing authorisations 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 marketing authorisations for Fumaderm were renewed. Fumaderm is indicated for the treatment of psoriasis.
4        The intervener, Biogen Netherlands BV, is the current holder of the marketing authorisations for Fumaderm.
5        On 28 February 2012, the intervener, 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 a marketing authorisation for the medicinal product for human use Tecfidera – Dimethyl fumarate (‘Tecfidera’). In that application, the intervener stated that Tecfidera was intended for the treatment of adult patients suffering from multiple sclerosis and that its only active substance was DMF. Moreover, it did not request that the ‘new active substance’ status of the DMF in Tecfidera be assessed.
6        On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on granting marketing authorisation for Tecfidera. In the light of the content of the intervener’s application, the CHMP did not examine whether DMF, the only active substance of Tecfidera, was a ‘new active substance’.
7        By letter of 18 September 2013, the European Commission requested the CHMP to assess whether DMF was different from Fumaderm, which is composed of DMF and MEF salts, with a view to determining whether it was a ‘new active substance’. By that letter, and following a request from the intervener, the Commission asked the CHMP to reconsider its assessment report with the view to including an assessment of 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.
8        On 21 November 2013, the CHMP delivered a revised opinion as compared to the opinion it had adopted on 21 March 2013 (see paragraph 6 above). In that revised opinion, the CHMP recommended, by consensus, the granting of a marketing authorisation 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’. It therefore concluded that MEF and DMF are both active and are not the same active substance since they do 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 for Tecfidera.
10      The Commission subsequently adopted Implementing Decision C(2014) 601 (final) of 30 January 2014 granting marketing authorisation under Regulation (EC) 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 decision was notified to the intervener 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 marketing authorisation holder. The Committee for Medicinal Products for Human Use 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/EC, and the already authorised medicinal product Fumaderm do not belong to the same global marketing authorisation as described in Article 6(1) of Directive 2001/83/EC.’
12      On 27 November 2017, Pharmaceutical Works Polpharma S.A. submitted a request to EMA for confirmation that it was eligible to submit an application for a marketing authorisation 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’), EMA informed Pharmaceutical Works Polpharma that it was unable to validate its application for a marketing authorisation, referred to in paragraph 12 above. 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 marketing authorisation 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, EMA took the view that Tecfidera benefited 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, Pharmaceutical Works 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 Court upheld the plea of illegality raised by Pharmaceutical Works 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 Court held, inter alia, in paragraph 282 of that judgment, that, ‘in view of the objectives of global marketing authorisations, 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 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 marketing authorisation than Fumaderm, which had previously been authorised, without verifying or requesting the CHMP to verify whether and, if necessary, how, the [Federal Institute for Medicinal Products and Medical Devices] 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, the intervener and EMA each brought an appeal against the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), registered under case numbers C‑438/21 P, C‑439/21 P and C‑440/21 P, respectively.
17      On 2 June 2021, the intervener submitted an application for a variation of its marketing authorisation 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, it also requested a one-year extension of the marketing protection for Tecfidera, pursuant to Article 14(11) of Regulation No 726/2004.
18      On 30 June 2021, Zentiva submitted in Germany, in the context of a decentralised procedure, pursuant to Article 6(1) read in conjunction with Article 10(1) and (2) of Directive 2001/83, an application for marketing authorisation for a generic DMF medicinal product. Tecfidera was designated as the reference medicinal product in that procedure.
19      In the course of complying with 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 held therein, inter alia, that ‘the available clinical data is not conclusive for the purpose of establishing that MEF has a clinically relevant therapeutic contribution within Fumaderm[,] … [that] 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 [and, therefore, that] the totality of the available data cannot establish that MEF exerts a clinically relevant therapeutic contribution within Fumaderm.’
20      On 27 January 2022, the CHMP adopted an initial opinion on the applications made by the intervener referred to in paragraph 17 above (‘the CHMP’s initial opinion of 27 January 2022’). First, it recommended that the requested variation to include an additional therapeutic indication in the marketing authorisation for Tecfidera be granted and concluded that the proposed new therapeutic indication brings a significant clinical benefit in comparison with existing therapies. Second, it recommended that the grant of an additional one-year of marketing protection be refused, as follows:
‘In 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 Judgment 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 type II variation application, from any marketing protection. As a result and without prejudice to the outcome of the above referenced appellate proceedings, the granting of an additional one-year of marketing protection period for Tecfidera cannot be recommended at this time.’
21      On 9 February 2022, the intervener submitted a request for re-examination of the CHMP’s initial opinion of 27 January 2022. That request was limited in scope to the section of that opinion in which a one-year extension of the marketing protection had not been recommended.
22      In a report of 22 April 2022, the CHMP confirmed its initial opinion of 27 January 2022, in particular in so far as concerns its conclusion that a clinically relevant therapeutic contribution of MEF within Fumaderm had not been demonstrated.
23      On 13 May 2022 the Commission adopted Implementing Decision C(2022) 3251 final amending the marketing authorisation granted by Decision C(2014) 601 (final) for Tecfidera (see paragraph 10 above). The Commission, first, granted the intervener’s application to extend the marketing authorisation for Tecfidera by adding a paediatric indication and, accordingly, amended Annexes I to III to Implementing Decision C(2014) 601 (final) and, second, refused to grant an additional year of marketing protection for Tecfidera, as requested by the intervener pursuant to Article 14(11) of Regulation No 726/2004.
24      On 17 August 2022, the public assessment report in the context of the decentralised procedure referred to in paragraph 18 above was adopted. That assessment report stated the following:
‘In 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 Judgment 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.’
25      On 5 September 2022, during the decentralised procedure referred to in paragraph 18 above, a marketing authorisation for the applicants’ generic DMF medicinal product was granted.
26      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.
27      On 2 May 2023, the Commission adopted the contested decision granting the intervener an additional year – until 2 February 2025 – of marketing protection for Tecfidera, in accordance with Article 14(11) of Regulation No 726/2004.
Forms of order sought
28      The applicants claim that the Court should:
–        annul the contested decision as well as any later decision, to the extent that they perpetuate and/or replace that decision including any follow-up regulatory actions, in so far as they relate to the applicants;
–        order the Commission to pay the costs of the proceedings.
29      The Commission contends that the Court should:
–        dismiss the action;
–        order the applicants to pay the costs.
30      The intervener contends that the Court should:
–        dismiss the action;
–        order the applicants to pay the costs.
Law
Admissibility
31      In their first head of claim (see paragraph 28 above), the applicants seek the annulment of any decisions taken after the contested measure to the extent that they perpetuate and/or replace that measure, including any follow-up regulatory actions, in so far as they relate to the applicants.
32      However, it must be noted that neither that part of the first head of claim nor the body of the application include any precision regarding the later decisions the annulment of which the applicants seek. It is apparent from the case-law that such heads of claim do not identify the subject matter of the proceedings in a sufficiently precise manner and must therefore be rejected pursuant to Article 76(d) of the Rules of Procedure of the General Court (see judgment of 12 May 2017, Costa v Parliament, T‑15/15 and T‑197/15, not published, EU:T:2017:332, paragraph 34 and the case-law cited).
33      It follows that the action is manifestly inadmissible in so far as it is directed against any decisions taken after the contested decision to the extent that they perpetuate and/or replace that measure, including any follow-up regulatory actions, in so far as they relate to the applicants.
Substance
34      In support of their action, the applicants put forward eight pleas in law. By their first plea in law, the applicants claim that the Commission failed to observe the time limit, laid down in Article 14(11) of Regulation No 726/2004, for obtaining an extension of market protection for a medicinal product for human use. The second plea in law alleges a manifest error in the interpretation of 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). In the third plea in law, the applicants claim that the Commission made a manifest error in basing the contested decision on incorrect scientific facts available at the time of the adoption of that decision. By the fourth plea in law, the applicants raise a plea of illegality against the implementing decision of 30 January 2014. The fifth plea in law alleges infringement of several of the applicants’ fundamental rights. In the sixth plea in law, the applicants claim that the Commission infringed the principle of legal certainty, by de facto withdrawing the applicants’ unconditionally granted market authorisation without assessing the illegality that had been committed. By the seventh plea in law, the applicants allege an infringement of the principle of legitimate expectations. The eighth plea in law concerns an infringement of the applicants’ right to property and of the principle of proportionality.
35      In the context of their first plea in law, the applicants indicate that an extension of the marketing protection for a medicinal product for human use from 10 to 11 years, as provided for in Article 14(11) of Regulation No 726/2004, may be granted only if an authorisation for a new therapeutic indication for that product is obtained within the first 8 years of the marketing authorisation being granted for that medicinal product. Therefore, according to the applicants, in order to be able to benefit from such an extension, the intervener was required to obtain an authorisation for the new therapeutic indication for Tecfidera during the first eight years following the grant of the corresponding marketing authorisation, which was not the case here.
36      In that regard, in the first place, the applicants submit that the intervener obtained the marketing authorisation for Tecfidera on 30 January 2014, notified on 3 February 2014, whereas the Commission decision to grant the intervener an authorisation for the new therapeutic indication was taken on 13 May 2022 by Implementing Decision C(2022) 3251 final, that is to say over three months after the expiry of the first eight years of the marketing authorisation for Tecfidera. The applicants claim that Tecfidera should therefore not be granted an additional year of marketing protection, since the intervener failed to comply with Article 14(11) of Regulation No 726/2004, which does not provide for any flexibility with regard to that rule. According to the applicants, the contested decision infringes the requirement of legal certainty.
37      In the second place, the applicants are of the view that the Commission cannot justify its failure to comply with the eight-year deadline laid down in Article 14(11) of Regulation No 726/2004 by relying on the lack of suspensive effect of the appeal procedure before the Court of Justice concerning the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241). According to the applicants, in the absence of suspensory effect, the Commission cannot grant an additional year of marketing protection after the expiry of that time limit.
38      In the third place, the applicants submit that, even if the intervener had not requested a re-examination after the CHMP’s initial opinion of 27 January 2022 (see paragraphs 20 and 21 above), it would have been impossible for it to obtain the authorisation referred to in paragraph 36 above within the period of eight years following the grant of the marketing authorisation for Tecfidera by the implementing decision of 30 January 2014, which was notified on 3 February 2014, given that only six days remained between the CHMP’s initial opinion of 27 January 2022 and the expiry of that period on 2 February 2022.
39      The Commission, supported by the intervener, disputes those arguments.
40      In the first place, the Commission submits that it was because of the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), that it was unable to issue a decision granting the additional year of marketing protection for Tecfidera in Implementing Decision C(2022) 3251 final of 13 May 2022. The Commission considers that, at the time the intervener submitted the application for variation of its marketing authorisation for Tecfidera, that is to say on 2 June 2021, that medicinal product was unable to benefit from a 10-year period of marketing protection as provided for in Article 14(11) of Regulation No 726/2004. According to the Commission, following the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), and the report of 11 November 2021, until 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 possible to recognise the ‘first eight years of those ten years’, within the meaning of Article 14(11) of Regulation No 726/2004, during which the intervener could have obtained an additional year of marketing protection, since such a period no longer existed.
41      However, the Court of Justice clarified, 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), that the 10-year period of marketing protection had to be recognised for the benefit of Tecfidera from the moment the medicinal product had been authorised in 2014. According to the Commission, when that judgment of the Court of Justice was delivered, it had become impossible for the Commission to adopt a decision within the first 8 years of those 10 years – that is to say before 3 February 2022, since the implementing decision of 30 January 2014 had been notified to the intervener on 3 February 2014. The Commission maintains that the only reasonable (teleological) interpretation of Article 14(11) of Regulation No 726/2004, in the particular and exceptional circumstances of the present case, was therefore that its decision had to be adopted within a reasonable period of time 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).
42      The Commission therefore concludes that it was the particular circumstances of the present case and its factual complexity which justified the acts adopted in compliance of the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), which subsequently became inconsistent 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).
43      In the second place, according to the Commission, in the absence of the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), it would not, on account of the obligation arising from the first paragraph of Article 266 TFEU, have triggered the assessment which gave rise to the report of 11 November 2021. The Commission submits that if the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241) and the report of 11 November 2021 had not existed, the additional year of marketing protection would have already been granted to Tecfidera by Implementing Decision C(2022) 3251 final of 13 May 2022 (see paragraph 23 above). Similarly, had it not been for the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), and the report of 11 November 2021, the intervener would not have requested the re-examination of the CHMP’s initial opinion of 27 January 2022 and, moreover, that opinion could have been delivered at an earlier date, since the CHMP would not have needed to wait for the conclusions of the procedure which led to the report of 11 November 2021.
44      In that regard, the Commission raises a plea of inadmissibility, claiming that the applicants’ rights relating to the placing on the market of a generic version of Tecfidera have not been hindered by the adoption of the contested decision since, before the expiration of the eight-year data protection period of Tecfidera, the applicants had already submitted an application for market authorisation for that generic product.
45      In the third place, the Commission disputes the applicants’ assertion referred to in paragraph 38 above. According to the Commission, in particularly urgent circumstances, it would have been able to act within six days of the CHMP’s opinion in order to comply with the eight-year time limit laid down in Article 14(11) of Regulation No 726/2004.
46      In that regard, in the first place, it should be noted that, contrary to what is claimed by the Commission in paragraph 44 above, the applicants’ rights relating to the placing on the market of a generic version of Tecfidera were affected by the adoption of the contested decision.
47      By granting Tecfidera, in the contested decision, an additional year of marketing protection, the contested decision extended from 3 February 2024 to 2 February 2025 the period of market exclusivity for that medicinal product. The contested decision therefore made it impossible for any generic version of Tecfidera to be placed on the market between 3 February 2024 and 2 February 2025. The possibility for the applicants to market generic versions of Tecfidera, in particular the one referred to in paragraph 25 above, during that period was therefore affected and the Commission’s plea of inadmissibility must be rejected.
48      The first plea requires, in essence, a determination of the scope of Article 14(11) of Regulation No 726/2004, and in particular the consequences of the failure, by the marketing authorisation holder for a medicinal product for human use, to comply with the time limit laid down for obtaining an authorisation for one or more new therapeutic indications bringing a significant clinical benefit in comparison with existing therapies, in order to be able to benefit from an additional year of marketing protection for the medicinal product in question. In the present case, the Commission relied on that provision in order to grant the intervener an additional year of marketing protection for Tecfidera, that is to say protection for 11 years instead of 10.
49      As a preliminary point, it must be borne in mind that Article 6(1) of Directive 2001/83 provides as follows:
‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation 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 (EC) No 726/2004 …
When a medicinal product has been granted an initial marketing authorisation in accordance with the first subparagraph, 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 or be included in the initial marketing authorisation. All these marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10(1).’
50      In addition, it should be noted that Article 14(11) of Regulation No 726/2004 is worded 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 eight-year period of data protection and a ten-year period of marketing protection, in which connection the latter period shall be extended to a maximum of 11 years if, during the first eight years of those ten years, the marketing authorisation 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.’
51      In the second place, it should be noted that it is in a context of balance between two complementary objectives, namely, first, to promote research on new therapeutic indications with a significant clinical benefit and bringing an improvement to the quality of life and welfare of the patient and, second, to favour the production of generic medicinal products, that the EU legislature provided that the additional year of marketing protection, provided for in Article 14(11) of Regulation No 726/2004, may be granted only where the new therapeutic indication is authorised within the first 8 years of those 10 years. That additional year of market exclusivity therefore constitutes, in the view of the EU legislature, the appropriate advantage to reward the investments in new therapeutic indications (judgment of 28 June 2017, Novartis Europharm v Commission, C‑629/15 P and C‑630/15 P, EU:C:2017:498, paragraphs 77 and 78).
52      However, the objectives referred to in paragraph 51 above can be achieved only if all the time limits in question set out in that paragraph are strictly complied with. Moreover, Article 14(11) of Regulation No 726/2004 does not provide for any derogation in that regard.
53      Accordingly, Article 14(11) of Regulation No 726/2004 must be interpreted as meaning that only the grant of an authorisation for one or more new therapeutic indications, during the first 8 years of the 10 years of marketing protection for the medicinal product for human use in question, is capable of allowing that period to be extended from 10 to 11 years. Obtaining that authorisation is therefore the necessary precondition for the grant of an additional year of marketing protection, that is to say, an extension from 10 to 11 years.
54      As regards the Commission’s argument that the only valid interpretation of Article 14(11) of Regulation No 726/2004, in the particular and exceptional circumstances of the present case, was that its decision be adopted within a reasonable time 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), it should be noted that, in the present case, what the applicants contest is not the period at the end of which the contested decision, which granted the extension of Tecfidera’s marketing protection from 10 to 11 years on the basis of Article 14(11) of Regulation No 726/2004, was adopted. What the applicants contest is, in essence, that the contested decision was adopted without the authorisation for a new therapeutic indication for Tecfidera having been obtained beforehand during the first 8 years of the 10-year marketing protection period for that medicinal product.
55      In that regard, first, it must be borne in mind that a medicinal product may be placed on the market in respect of a new therapeutic indication only after a variation of the initial marketing authorisation has been obtained (see paragraphs 49 and 50 above).
56      Second, it follows from a combined reading of Article 6(1) of Directive 2001/83 and Article 14(11) of Regulation No 726/2004 that it is open to the marketing authorisation holder for a medicinal product to apply for a variation of that marketing authorisation with a view to obtaining an authorisation for a new therapeutic indication for that medicinal product, whether or not that medicinal product belongs to a global marketing authorisation for another medicinal product. In addition, it is possible to apply for that authorisation without necessarily also requesting an extension of the marketing protection for the medicinal product in question.
57      It was in this context that the intervener was able to make an application to obtain authorisation for a new therapeutic indication for Tecfidera on 2 June 2021 (see paragraph 17 above), that is to say, almost 1 month after the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), and subsequently obtained that authorisation on 13 May 2022 (see paragraph 23 above), that is to say, more than 10 months before 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), despite the fact that Tecfidera was at that time considered to belong to the same global marketing authorisation as Fumaderm (see paragraph 15 above), within the meaning of Article 6(1) of Directive 2001/83.
58      Thus, first, the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), in no way precluded the submission of the application and the grant of an authorisation for the new therapeutic indication. Moreover, there was nothing to prevent the intervener from submitting an application to that effect to the Commission before 2 June 2021. Nor, second, did that judgment prevent the Commission from taking a decision on that application by the intervener in the first 8 years of the initial 10-year period of marketing protection for Tecfidera (in other words, before 3 February 2022), irrespective of the application for an extension of that period from 10 to 11 years.
59      In those circumstances, it has not been demonstrated that the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), had any bearing on the lack of a grant of an authorisation for a new therapeutic indication for Tecfidera within the period laid down in Article 14(11) of Regulation No 726/2004 and, therefore, on the failure to comply with that condition prior to the grant of the extension of the marketing protection period of that medicinal product from 10 to 11 years.
60      In the third place, it should be borne in mind that, according to settled case-law, as a consequence of a judgment annulling an act, which takes effect ex tunc and thus has the effect of retroactively eliminating the annulled act 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 as found in that judgment. In the case of an act that has already been implemented, this may take the form of restoring the applicant to the position he or she 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).
61      Those measures do not concern the elimination of the act as such from the EU legal order, since that results from the act’s annulment by the Court. They concern, rather, the removal of the effects of the illegalities found in the judgment annulling the act, in order 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).
62      In the light of the case-law referred to in paragraphs 60 and 61 above, it is true that it was for the Commission and 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), to examine what measures would be necessary to restore the intervener to the situation, as the holder of the marketing authorisations for Fumaderm and Tecfidera, it was in before 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.
63      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), the latter cannot rely on its competence under that article to alter the scope of the provisions of the legislation in force. Indeed, the Commission is obliged to comply with the judgments of the Court in accordance with the applicable EU law, of which it is the guardian.
64      As was concluded in paragraph 53 above, obtaining an authorisation for a new therapeutic indication for a medicinal product is, according to Article 14(11) of Regulation No 726/2004, a necessary prerequisite for granting an extension of the marketing protection period for that medicinal product from 10 to 11 years.
65      Therefore, contrary to what the Commission claims, the acts taken in order to comply with the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), did not become incompatible 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).
66      Irrespective of the judgment of 5 May 2021, Pharmaceutical Works Polpharma v EMA (T‑611/18, EU:T:2021:241), the Commission could not grant, in Implementing Decision C(2022) 3251 final of 13 May 2022, a one-year extension of the marketing protection period for Tecfidera, since the condition laid down in Article 14(11) of Regulation No 726/2004, namely the prior obtention, within the eight-year period, of authorisation for a new therapeutic indication for that medicinal product, was not satisfied.
67      In that regard, although the intervener submitted an application for authorisation of a new therapeutic indication for Tecfidera on 2 June 2021, the fact remains that, on the date of adoption of Implementing Decision C (2022) 3251 final, namely 13 May 2022, the eight-year period during which an authorisation for one or more new therapeutic indications for that medicinal product, deemed to bring a significant clinical benefit in comparison with existing therapies, had to be obtained had already expired, on 2 February 2022 (see paragraph 58 above), which therefore precluded the grant, by the contested decision, of the extension of the marketing protection period for Tecfidera from 10 to 11 years.
68      Consequently, it must be held 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), does not alter the conclusion, set out in paragraph 53 above, that Tecfidera could benefit from an extension of the period of marketing protection from 10 to 11 years only if the necessary prerequisite for the grant of such an additional year was complied with, namely the obtention, during the first 8 years of that 10-year period, of an authorisation for a new therapeutic indication.
69      Therefore, in the light of the principles that follow from the case-law referred to in paragraphs 60 and 61 above, the necessary measures that the Commission and EMA must take in order 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), cannot entail an amendment of Implementing Decision C (2022) 3251 final to introduce therein an extension, from 10 years to 11 years, of the marketing protection period for Tecfidera.
70      It follows from all of the foregoing that the contested decision, taken with a view to 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), was not adopted in accordance with EU law, as required by the case-law referred to in paragraphs 60 and 61 above, and therefore did not comply with Article 266 TFEU.
71      Accordingly, the first plea in law must be upheld.
72      The contested decision must therefore be annulled, without there being any need to examine the other pleas put forward by the applicants. Moreover, there is no need to rule on the admissibility, disputed by the Commission, of the evidence produced by the applicants on 15 November 2024, under Article 85(3) of the Rules of Procedure, given that the ruling adopted is not based on factors contained in that evidence.
Costs
73      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.
74      In the present case, since the Commission has been largely unsuccessful, it must be ordered to pay the costs, including the costs relating to the interim proceedings before the Court, in accordance with the form of order sought by the applicants.
75      In accordance with Article 138(3) of the Rules of Procedure, the intervener must bear its own costs.
On those grounds,
THE GENERAL COURT (Fourth Chamber)
hereby:
1.      Annuls Commission Implementing Decision C(2023) 3067 (final) of 2 May 2023 amending the marketing authorisation granted by Decision C(2014) 601 (final) for ‘Tecfidera – Dimethyl fumarate’, a medicinal product for human use;
2.      Dismisses the action as to the remainder;
3.      Orders the European Commission, in addition to bearing its own costs, to pay the costs incurred by Zentiva k.s. and by Zentiva Pharma GmbH, including those relating to the interim proceedings before the Court;
4.      Declares that Biogen Netherlands BV is to bear its own costs.
da Silva Passos
Reine
Pynnä
Delivered in open court in Luxembourg on 24 September 2025.
V. Di Bucci
S. Papasavvas
Registrar
President
*      Language of the case: English.