GCEU overturns extension of regulatory market protection for Tecfidera

The saga surrounding the long-disputed market protection for Biogen's multiple sclerosis medicinal product Tecfidera (dimethyl fumarate) has added another chapter. In its judgment of 24 September 2025, T-256/23 – Mylan/Commission, the General Court of the European Union (GCEU) annulled the Commission's decision of 2 May 2023 to extend the market protection for Tecfidera by one year at the request of Mylan and also upheld the actions for annulment brought by seven other generic manufacturers in the respective parallel proceedings.

The case is caught between the conflicting interests of incentives for indication-related research and timely market access for generics. The necessary balance of interests between original manufacturers and generic manufacturers is currently achieved through the so-called 8+2+1 rule: upon approval, the study data for the original product are initially subject to eight years of data protection, followed by two years of market protection, which is extended by an additional year

„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“. (See Art. 14 para. 11 Regulation (EC) No 726/2004 resp. Art. 10 para. 1 subpara. 4 Directive 2001/83/EC.)

For Tecfidera, the relevant eight-year period expired on 2 February 2022, based on the initial authorisation on 30 January 2014 respectively its notification on 3 February 2014. However, the Commission did not approve the new paediatric indication until 13 May 2022, more than three months late. The GCEU has now ruled that, in view of the extension of the indication outside the eight-year period, the factual requirements for the Commission's decision of 2 May 2023 were not met and that the one-year extension of market protection for Tecfidera was therefore unlawful.

I. Strict eight-year period for the extension of indications

With regard to Art. 14 para. 11 Regulation (EC) No 726/2004, the GCEU first noted that the granting of an authorisation for a new therapeutic indication during the first eight years is a factual requirement for an extension of market protection. In view of the clear wording and the intended balance of interests, this eight-year period must be interpreted strictly and does not provide for any exceptions. The Commission had argued that the specific circumstances of the case – in particular the interim stage following the judgment of the GCEU of 5 May 2021, T-611/18 in the parallel proceedings Polpharma/EMA, which had rejected Tecfidera's market protection in its entirety in the context of an incidental finding under Art. 277 TFEU, and prior to the subsequent annulment judgment of the CJEU of 16 March 2023, C-438/21 P to C-440/21 P – Polpharma/EMA – requires a more flexible approach to the eight-year period and a "reasonable period" following the CJEU ruling. However, the GCEU counters that the period until the contested decision to extend the market protection for Tecfidera was delivered is not at issue. Rather, the question is whether the extension decision could be lawfully issued even though the extension of the indication had not been obtained within the first eight years. The GCEU rejects this argument on two grounds: firstly, neither interim legal uncertainties nor the implementation of court decisions allowed for a deviation from the clear, time-bound system of Art. 14 para. 11 Regulation (EC) No 726/2004. Secondly, Biogen itself could have initiated the application procedure more quickly and the Commission could have delivered a decision before the deadline expired. Neither the GCEU judgment of 5 May 2021 nor its annulment on 16 March 2023 would have blocked the application and approval of the new paediatric indication before 2 February 2022.

II. No circumvention through Art. 266 TFEU

The GCEU also states that Art. 266 TFEU does not justify circumventing the eight-year period. Clearly, Art. 266 TFEU imposes an obligation on the Commission to remove the effects of established infringements and to restore the lawful situation. The Commission therefore had to reinstate Biogen, following the subsequent annulment judgment of the CJEU of 16 March 2023 with ex tunc effect, to the position it had held as the marketing authorisation holder for Tecfidera prior to the judgment of the GCEU of 5 May 2021. At the same time, however, the GCEU makes it clear that Art. 266 TFEU does not constitute a source of competence and does not entitle the Commission to modify substantive legal requirements or time limits under secondary law. Rather, the implementation of a judgment must be carried out "in accordance with the applicable EU law". For this reason, the Commission was not permitted to circumvent the time limit mechanism laid down in Art. 14 para. 11 Regulation (EC) No 726/2004 by granting a one-year extension of market protection, even though the authorisation of the new indication had not been obtained within the first eight years.

III. No consideration of the other pleas in law

In view of the infringement of the eight-year period in Art. 14 para. 11 Regulation (EC) No 726/2004 and the associated success of the first plea, the GCEU finally declares that it is not necessary to examine the other eight pleas in law put forward. The GCEU thus does not address the fundamental issues at stake in the original case, such as whether Biogen was ever entitled to market protection for Tecfidera and whether the generic authorisations were lawfully granted.

IV. Conclusion and outlook

The decision of the GCEU has general significance beyond the specific case. The decision establishes clear guidelines for the application of the eight-year period under Art. 14 para. 11 Regulation (EC) No 726/2004, within which the new indication must be approved. In addition, the GCEU rejects the Commission's attempt to circumvent the eight-year period via Art. 266 TFEU. Institutions cannot therefore invoke Art. 266 TFEU when enforcing judgments in order to soften strict legal requirements. Legal and planning certainty – in this case in favour of generic competition – take precedence over executive corrective measures. For marketing authorisation holders, this means that the development and approval of new indications within the framework of second medical use projects must be planned and completed within the specified time frame. At the same time, the decision means predictability of the regulatory protection period and thus legal certainty. Furthermore, the strict standard for interpreting time limit regulations is likely to remain applicable even after the currently discussed reform of EU pharmaceutical regulation (see COM(2023) 192 and COM(2023) 193, although with regard to the six-year data protection period envisaged by the Commission).

However, the decision, which is not yet legally binding, only partially contributes to resolving the extremely complex initial case. The GCEU fails to address the crucial question at the heart of the conflict, namely whether Tecfidera was even entitled to claim market protection. In addition, although the GCEU has revoked the one-year extension of market protection for Tecfidera, the additional year of exclusivity had already expired on 3 February 2025. For generic manufacturers, the focus is now likely to shift to examining retroactive claims for damages, depending on their respective market entry. Important insights are expected from the pending decisions of the GCEU on the actions for annulment brought by various generic manufacturers against the Commission's decisions of 13 December 2023, in which the Commission revoked their generic marketing authorisations.