The European Commission’s implementing decision of May 2, 2023, which extended the marketing protection for Tecfidera (Biogen) pursuant to Article 14(1) of Regulation No. 726/2004 for a further year until February 2025, was annulled by the General Court in its judgment of September 24, 2025.
I. Introduction
Preu Bohlig has filed separate actions for annulment with the General Court of the European Union on behalf of two generic drug companies against the European Commission’s implementing decision of May 2, 2023, amending the marketing authorization for the human medicinal product “Tecfidera/dimethyl fumarate” granted by Decision C(2014) 601 final, by which the Commission extended the marketing protection for Tecfidera by an additional year in accordance with Article 14(11) of Regulation No. 726/2004, so that the marketing protection expired 11 years after the entry into force of the Commission’s Implementing Decision C 2014/601 final of February 3, 2014 (marketing authorization for Tecfidera), thus ending on February 3, 2025.
In the present proceedings, the Commission, supported by the originator Biogen (reference medicinal product), and numerous generic companies disputed the question of whether the reference medicinal product Tecfidera enjoys marketing protection at all, or whether it is not covered by a previously granted global marketing authorization and the +1-year extension of marketing protection was granted unjustifiably.
In these proceedings, numerous regulatory issues of the highest level relating to drug approval, which had not yet been decided, were disputed, and numerous law firms (and authorities) in Germany and abroad were involved in interpreting the ECJ decision and its impact, as well as the significance of Article 14 of Regulation No. 726/2004 and the Commission decision.
II. Facts of the case
Initially, regulatory authorities accepted the data protection for Tecfidera based on a CHMP assessment report dated November 26, 2013, which assumed that dimethyl fumarate (DMF), the active ingredient in Tecfidera, differs from the long-approved drug Fumaderm, which consists of a mixture of dimethyl fumarate (DMF) and ethylene hydrogen fumarate (MEF), so that this supposedly new active ingredient would be eligible for data protection and marketing protection for a total period of 10 years.
Polpharma filed a lawsuit against this with the General Court on October 9, 2018, which was decided by judgment of May 5, 2021 (Case T-611/18). A detailed description of the facts relating to the approval of Fumaderm and Tecfidera, as well as Polpharma’s legal action, can be found in paragraphs 1-50 of the judgment in Case T-611/18.
In its judgment of May 5, 2021, the General Court annulled the decision of the European Medicines Agency (EMA) rejecting Polpharma’s application for a generic marketing authorization for Tecfidera on the grounds that the EMA should have verified that the active substances in question made a therapeutic contribution in each case.
On June 12, 2021, the originator Biogen applied for a Type II variation to approve a new therapeutic indication for Tecfidera, thereby extending the approved use of Tecfidera to part of the pediatric population and extending the 10-year market protection period by one year. The one-year extension of market protection for Tecfidera was rejected by the European Commission in its implementing decision of May 13, 2022 (C (2022) 3251 (final) on the grounds that, in its judgment of May 5, 2021, in Case T-611/18, the General Court had found that EMA Decision C(2014) 601 (final) (marketing authorization for Tecfidera) was not applicable insofar as the Commission had determined in this implementing decision that Tecfidera was not part of the same comprehensive marketing authorization as Fumaderm. In an ad hoc opinion issued on November 11, 2021, the European Medicines Agency stated that the totality of the available data could not demonstrate that monoethyl fumarate salts (MEF) made a clinically relevant therapeutic contribution in Fumaderm. On this basis, the CHMP concluded that, regardless of the outcome of the appeal against judgment T-611/18, the granting of a one-year extension of marketing protection for Tecfidera could not be recommended at this stage. Therefore, the EMA considered that it could not grant an extension of marketing protection for a further year in accordance with Article 14(11) of Regulation (EC) No. 726/2004, according to Implementing Decision C(2022) 321 final of May 13, 2022.
In its judgment of March 16, 2023, in joined cases C-438/21 P to C-440/21 P, the ECJ then overturned the judgment of the General Court of May 5, 2021, and found that, contrary to what was assumed in the contested judgment, the Commission was entitled to rely on the CHMP’s assessment of whether DMF differs from Fumaderm, which consists of DMF and MEF, before adopting the implementing decision of January 30, 2014. The Commission’s implementing decision of May 2, 2023, which replaced Decision C (2022) 3251 final of May 13, 2022, and which was challenged in the actions before the General Court, then extended the marketing protection for Tecfidera by one additional year. The granting of the additional indication, which according to the wording is a prerequisite for the extension of marketing protection, had not been granted within the first eight years from the date of marketing authorization as specified in Article 14 of Regulation No. 726/2004.
In the actions for annulment brought, Preu Bohlig essentially complained that this contested decision had been issued without the approval for a new therapeutic indication for Tecfidera having been granted during the first eight years of the ten-year marketing protection for this medicinal product, as required by the wording of the provision.
III. The decisions of the General Court
First, as usual, the court sets out the facts of the case and the arguments put forward in detail before setting out its opinion on the ground of appeal concerning non-compliance with the time limit laid down in Article 14(11) in the grounds for its decision.
The court then begins its subsumption by stating that this ground of appeal essentially concerns the determination of the scope of Article 14(11) of Regulation No 726/2004 and, in particular, the consequences of the holder of the authorization failing to comply with the time limit for obtaining therapeutic indications in order to be able to benefit from an additional year of marketing protection.
To this end, the provision of Article 6(1) of Directive 2001/83 and Article 14(11) of Regulation No 726/2004 are reproduced in order to then set out two complementary objectives of the EU legislature which must be taken into account. On the one hand, the objective of promoting research into new therapeutic indications that represent a significant clinical benefit and, on the other hand, the objective of promoting the production of generic medicines, which is why Article 14(11) of Regulation No 726/2004 provides that the extension of marketing protection by an additional year only in cases where the new area of application is approved within the first 8 years of those 10 years. In the view of the EU legislature, this extension of the period of market exclusivity by 1 year represents an appropriate advantage to compensate for investment in new therapeutic indications.
The Court then concludes that these objectives can only be achieved if all the deadlines mentioned are strictly adhered to. Furthermore, Article 14(11) of Regulation No 726/2004 does not provide for any exception in this respect.
Ultimately, the court therefore comes to the satisfactory conclusion that Article 14(11) of Regulation No. 726/2004 must be interpreted as meaning that only the granting of an authorization for one or more new therapeutic indications during the first 8 years of a 10-year period of marketing protection for the medicinal product for human use concerned can allow that period to be extended from 10 to 11 years. Obtaining this authorization is therefore the necessary prerequisite for granting an extension of marketing protection by one additional year, i.e., an extension from 10 to 11 years.
In addition, the Court clearly points out, with regard to the Commission’s submission and the allegedly special and exceptional circumstances of the case, that we had in fact essentially only complained that the contested decision had been adopted without the authorization for a new therapeutic indication for Tecfidera having been obtained beforehand during the first 8 years of the 10-year marketing protection for this medicinal product.
The Court then expressly states that the marketing of a medicinal product for a new therapeutic indication is only possible after obtaining a modification of the original marketing authorizations and that it follows from Article 6(1) of Directive 2001/83 in conjunction with Article 14(11) of Regulation No. 726/2004 that the holder of a marketing authorization for a medicinal product is free to apply for a variation of that authorization in order to obtain an authorization for a new therapeutic indication for that medicinal product, regardless of whether or not that indication forms part of a comprehensive marketing authorization for another medicinal product. Furthermore, it is possible to apply for such an authorization without necessarily also applying for the extension of marketing protection for the medicinal product concerned at the same time.
It then specifically comments on Biogen’s application of June 2, 2021, and the authorization received on May 13, 2022, more than 10 months before the ECJ ruling of March 16, 2023, and fortunately clearly concluded that the ruling of May 5, 2021 did not in any way prevent the submission of the application and the obtaining of approval for the new therapeutic indication. Similarly, Biogen could have submitted a corresponding application to the Commission before June 2, 2021.
The court also makes it clear that, on the other hand, this judgment did not prevent the Commission from deciding on Biogen’s application within the first 8 years of the original 10-year period of marketing protection for Tecfidera—i.e., before February 3, 2022 , regardless of the application to extend the marketing protection from 10 to 11 years.
This means that it has not been proven that the judgment of May 5, 2021, had any effect on the non-granting of approval for a new area of application for Tecfidera within the prescribed period.
The court then found that, according to established case law, following a judgment of annulment that applies ex tunc and thus retroactively invalidates the act declared void, the defendant institution is obliged under Article 266 TFEU to take the necessary measures to eliminate the effects of the infringement found. In the case of an act that has already been performed, it may be necessary to restore the plaintiff to the position he was in before that act.
In this regard, the Court expressly states that these measures do not, however, concern the removal of the acts as such from the legal order of the Union, as this already followed from the judicial annulment of the act. Rather, they concern the elimination of the effects of the infringements established in the judgment of annulment in order to bring them into line with Union law.
In this respect, in light of this case law, it was incumbent on the Commission and the EMA, in the context of implementing the judgment of March 16, 2023, to examine what measures would be necessary to restore Biogen to the position it was in as the holder of the marketing authorizations for Fumaderm and Tecfidera prior to the judgment of May 5, 2020, which was annulled by the Court of Justice. 2021.
Finally, the Court clearly stated that obtaining approval for a new therapeutic indication for a medicinal product under Article 14(11) of Regulation No 726/2004 was a necessary condition for granting an extension of the marketing protection for that medicinal product from 10 to 11 years. Therefore, contrary to the Commission’s submission, the actions taken in implementation of the judgment of May 5, 2021, had not become incompatible. Irrespective of this judgment, the Commission was unable to grant a one-year extension of marketing protection for Tecfidera in Implementing Decision C (2022) 3251 final of May 13, 2022, grant a one-year extension of marketing protection for Tecfidera, as the condition laid down in Article 14(11) of the Regulation, namely the prior approval of a new indication within the eight-year period, had not been met. The judgment of the ECJ of March 16, 2023, does not alter this finding.
Furthermore, the encouraging conclusion is drawn that, in light of the principles of the case law referred to, the necessary measures that the Commission and the EMA had to take to implement the ECJ ruling of March 16, 2023, did not lead to an amendment of Implementing Decision C (2022) 3251 final in order to introduce an extension of the duration of marketing protection for Tecfidera from 10 to 11 years.
In light of the foregoing, the contested decision, which was adopted in implementation of the judgment of March 16, 2023, was not adopted in accordance with Union law and therefore infringes Article 266 TFEU. Consequently, the contested decision had to be declared void.
IV. Summary
What is particularly pleasing about the General Court’s decisions of September 24, 2025, is not only that the court ruled in favor of Preu Bohlig and annulled the Commission’s Implementing Decision C (2023) 3067 final of May 2, 2023, amending the authorization granted by Decision C (2014) 601 final for the medicinal product for human use “Tecfidera-dimethyl fumarate,” but also, in particular, that the Court based its reasoning for reaching this conclusion entirely on the key arguments put forward by Preu Bohlig.
