Revived Data Exclusivity: EU Court Confirms Withdrawal of Generic Authorisation

Dimethyl Fumarate Neuraxpharm Fails Due to Breach of Data Exclusivity

Introduction: Data Exclusivity, Centralized Authorisation and the Retroactive Effect of Court Decisions

By way ofUrteil vom 11. Februar 2026 (T-1182/23)has theCourt of Justice of the European Union (EuG)rendered a landmark decision for Europeanpharmaceutical authorisation law. The central question is whether theEuropean Commissionmay revoke an already grantedmarketing authorisation (MA)for a generic medicine if it subsequently transpires – on the basis of a judgment of the Court of Justice of the European Union (EuGH) – that the underlyingdata exclusivity of the reference medicinal productcontinued to exist.

The judgment clarifies the interplay betweenArt. 6 Abs. 1 RL 2001/83/EG (Zulassung von Arzneimitteln),Art. 14 Abs. 11 VO (EG) Nr. 726/2004 (Datenexklusivität und Marktexklusivität)andArt. 266 AEUV (Umsetzung gerichtlicher Entscheidungen). Particularly significant is the EuG's clear statement: if a Union court decision is set aside, the original legal position revivesex tunc– with immediate consequences for authorisations granted in the interim.

Exactly what was at stake: Tecfidera, Fumaderm and the controversial centralized authorisation

The starting point of the long-running dispute is the multiple sclerosis medicinal productTecfidera (Dimethylfumarat, DMF), which was authorized in 2014 through the centralized procedure. Since 1994, the combination productFumaderm(DMF + Monoethylfumarat salts, MEF) has been authorized in Germany.

The decisive question was whether Tecfidera and Fumaderm belong to the same"centralized authorisation"within the meaning of Art. 6 Abs. 1 RL 2001/83/EG. Had this been the case, Tecfidera would not have received its owneight-year data exclusivity. However, the Commission followed the CHMP (Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA)) and determined that DMF and MEF do not share an identicaltherapeutic moiety,which is the part of a drug molecule or ion responsible for the pharmacological effect in the body. Tecfidera was therefore a separate medicinal product with its own centralized authorisation.

This classification resulted in Tecfidera receiving its owndata exclusivity and market exclusivityunder Art. 14 Abs. 11 VO 726/2004.

In 2021, the EU Court declared this Commission decision unlawful in proceedings brought by another generic manufacturer. In implementation of this judgment, the CHMP reconsidered whether MEF in Fumaderm made a clinically relevant therapeutic contribution. In its report of 11 November 2021, the CHMP concluded that no such contribution had been demonstrated.

On this basis, the Commission grantedNeuraxpharman authorisation forDimethyl Fumarate Neuraxpharmin May 2022.

However, in March 2023, theCourt of Justice of the European Union (EuGH)set aside the EU Court judgment and confirmed the lawfulness of the original Commission decision from 2014. It was thus established that Tecfidera has its own centralized authorisation and the corresponding data exclusivity continued to exist.

In implementation of this Court of Justice judgment, the Commission revoked the Neuraxpharm authorisation in December 2023. The present action is directed against this revocation.

Legal reasoning of the EU Court: the therapeutic moiety is decisive – not the subsequent scientific reassessment

The EU Court closely follows the Court of Justice judgment of 2023.

Central is the interpretation of the concept ofcentralized authorisationunder Art. 6 Abs. 1 RL 2001/83/EG in conjunction with Regulation (EC) No. 726/2004. The Court of Justice had clarified that two medicinal products with differentqualitative compositiondo not belong to the same centralized authorisation if they do not share an identicaltherapeutic moietypossess.

In the case of Tecfidera and Fumaderm, it is decisive that DMF and MEF have different therapeutic moieties. An additional examination as to whether MEF in Fumaderm is actually clinically effective is not legally required for the classification in the centralised procedure legally not required.

The General Court thus declares the CHMP report of 2021 on the therapeutic relevance of MEF to be legally irrelevant. Even if this report contains new scientific findings, this does not change the legal assessment of the centralised procedure.

Retroactive effect pursuant to Art. 266 TFEU: ex tunc restoration of exclusivity

Of particular practical importance is the application of Art. 266 AEUV.

The General Court emphasises that a judgment of the Court of Justice has, in principle, ex tunc effect. Where a judgment is set aside, the annulling effect ceases to apply with retroactive effect, so that the original decision is deemed to have been lawful from the outset.

Consequence:

• The Commission decision of 2014 remained effective.
• The independent data exclusivity of Tecfidera continued to exist.
• The generic authorisation granted in 2022 was thus unlawful under EU law from the outset.

The Commission was therefore obliged to restore the lawful state – and not only in relation to the original applicant, but vis-à-vis all affected generic manufacturers.

No restriction of revocation to safety grounds

Neuraxpharm argued that an authorisation could only be revoked on grounds of quality, safety or efficacy. The General Court rejects this.

A breach of the data exclusivity affects a material authorisation prerequisite. If an authorisation is granted in breach of this prerequisite, it is unlawful and may be revoked. Art. 81 VO 726/2004 requires that authorisation decisions be based exclusively on the grounds provided for in the Regulation.

Practice consequences: Substantial strategic risks for generic manufacturers

The judgment has substantial implications for the regulatory strategy of generic manufacturers:

• An authorisation may be lost even after being granted if the legal situation changes as a result of a judgment on appeal.
• Ongoing proceedings concerning centralised authorisation, the New Active Substance (NAS) classification or data exclusivity entail substantial market entry risks.
• Scientific re-evaluations may be legally irrelevant if the EU law classification has already been settled.

Companies must therefore develop a robust litigation and market entry strategy in the event of pending appeal proceedings.

Recommendation for the pharmaceutical industry

Prior to submitting a generic application, manufacturers should carefully examine:

• Is the reference authorisation definitively secured by a court of the European Union?
• Is there uncertainty regarding the centralised authorisation?
• What financial risks arise in the event of a later ex tunc revocation?
• Are contractual and market-based safeguarding mechanisms in place?

In particular in complex constellations involving earlier combination products or differing active ingredient composition, an in-depth EU law analysis is essential.

Our law firm specialising in pharmaceutical law, in particular pharmaceutical regulatory law AVANTCORE Rechtsanwälte in Stuttgart advises pharmaceutical companies comprehensively on data exclusivity, in all authorisation matters, on New Active Substance classification, on Hybrid and generic approvals as well as in proceedings before national courts, EMA, European Commission, EuG and EuGH.

We develop legally secure approval and market entry strategies for you and represent your interests in complex regulatory and legal disputes at both national and European level.