29 January 2026

Is repeated use of Art. 10(b) Directive 2001/83 for fixed-dose combinations allowed? Preliminary questions to CJEU

29 January 2026

On 24 December 2025, the Council of State (the highest administrative body in NL, hereafter: “Council”) issued its judgment in the administrative appeal proceedings between the Dutch Medicines Evaluation Board (‘‘CBG’’) and several generic companies incl. Laboratorios Cinfa S.A. (‘‘Cinfa’’) against Organon N.V. (‘‘Organon’’). The case concerns fixed-dose combination (“FDC”) products containing ezetimibe and atorvastatin and the use of the simplified procedure for obtaining a marketing authorisation (“MA”) based on Art. 10(b) of Directive 2001/83 (the “Directive”). In the NL version of the Directive, Art. 10(b) is article is referred to as Art. 10ter). The Council stayed the proceedings and referred two preliminary questions to the Court of Justice of the European Union (“CJEU”). The answers to these questions are particularly important, as they may determine whether Art. 10(b) of the Directive can be relied on more than once for the same FDC, allowing subsequent applicants to obtain an MA without submitting a full dossier on the mono products and instead to provide new data only on the FDC itself.

What preceded

Cinfa applied in NL for several MAs for FDC products containing ezetimibe and atorvastatin. The CBG granted these MAs under the simplified requirements of Art. 10(b) of the Directive. For the same combination, the CBG had already granted an MA to Organon for its product Atozet. This MA was also based on the Art. 10(b) procedure. Both Organon and Cinfa submitted their own dossier for the FDC, relying on the existing mono product dossiers for the respective individual active substances, which were no longer protected by data/market exclusivity. Furthermore, the indications do not fully overlap. Cinfa’s products are indicated as a substitution therapy.

Organon objected to the MAs granted to Cinfa. The CBG dismissed Organon’s objections. Organon therefore appealed to Administrative Division of the District Court of Noord Holland (the “Court”). The Court held that the MAs for Cinfa’s FDC could not lawfully be granted using the Art. 10(b) procedure. In the Court’s view, ezetimibe and atorvastatin had already been combined “for therapeutic purposes” in Atozet. On a literal reading, Art. 10(b) only applies where the active substances “have not hitherto been used in combination for therapeutic purposes”. Once an FDC has been authorised under Art. 10(b), thesame combination can therefore no longer benefit fromthat simplified route. Both the CBG and Cinfa appealed to the Council.

Interpretation of Article 10 (b) Directive 2001/83

The Council notes that Art. 10(b) offers a simplified route for FDCs where each active substance is already authorised as a mono product and its data exclusivity has expired. The applicant may rely on the existing mono product dossiers and only has to provide new preclinical and/or clinical data for the combination product itself. The Council states that the primary objective of the Directive is the protection of public health, while it also aims to avoid unnecessary repetition of animal/human testing, but also to create an environment that does not unduly hinder pharmaceutical innovation and competition.

The Council points out that the phrase “have not hitherto been used in combination for therapeutic purposes” could be read as implying that only the first FDC of particular active substances may rely on Art. 10(b). Thus, once an MA has been granted under Art. 10(b) for a given combination, subsequent applicants for the same combination would be excluded from using this provision.

However, the Council observes that this textual reading does not fully align with the objectives and structure of the Directive. In regulatory practice, a substantial majority of Member States allow multiple Art. 10(b) MAs for the same combination, provided each applicant submits its own dossier for the FDC and does not rely on data still under protection. The CMDh has endorsed this approach, and the European Commission has, in several opinions and a 2022 letter, taken the position that multiple Art. 10(b) applications for the same combination are not excluded as long as regulatory data protection is respected. The Council also refers to the decision of the Spanish ‘Tribunal Supremo’, which held that neither national nor EU law precludes repeated use of Art. 10(b) for the same combination, and notes that similar litigation is pending in France. In view of the divergent national case law and administrative practice, the Council concludes that the interpretation of Art. 10(b) is not an acte clair and that there is a risk of inconsistent application across the EU.

The preliminary questions to the CJEU

To ensure a uniform interpretation of Art. 10(b), the Council refers two questions to the CJEU: 1. Whether Art. 10(b) of the Directive must be  nterpreted as allowing a subsequent MA for the same FDC of active substances to be granted under that provision, even where an earlier MA for that combination has already been granted using Art. 10(b)? 2. Whether, when answering the first question, it is relevant that the subsequent combination product is
applied for with a different therapeutic indication from that of the earlier combination product – i.e. whether a different indication implies a different “therapeutic purpose” within the meaning of Art. 10(b)?

Conclusion

The forthcoming CJEU judgment will clarify whether Art. 10(b) can be relied on more than once for the same FDC and whether differences in therapeutic indications are relevant for that assessment. The outcome will clarify the way to go forward with MA applications for FDC products by using the Art 10(b) route, a full-dossier application or a belated generic application.

Author
M.H.J. (Marleen) van den Horst

Attorney at Law & Partner

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Author
I. E. H. M. (Iris) Arts

Attorney at Law

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Assessment of the Court – First MA The Court analyses the caselaw of the CJEU in order to answer the question how to interpret ‘’first MA’’ within the meaning of Article 3(d) of the SPC Regulation. First, the Court considers the interpretation given by the CJEU in Santen of the term ‘’product’’ under Articles 1(b) and 4 of the SPC Regulation, as exclusively referring to the active substance or combination of active substances, irrespectively of the therapeutic use or target species. The term “product” needs to be interpreted strictly. The first MA relates to the authorisation of a product containing the active substance or combination of active substances in question, regardless of the therapeutic application of the active substance(s) for which that MA was granted (see also CJEU decision Abraxis Bioscience (C-443/17)). The Court further refers to Pharmacia, in which the CJEU held that no fundamental distinction is to be made between human and veterinary medicinal products in applying the SPC Regulation. The difference in intended use (human or animal) is not a decisive criterion for the grant of an SPC. The Court observes that Boehringer’s reading of Neurim could not be reconciled with the CJEU’s subsequent judgments, particularly Santen, in which the Court expressly distanced itself from its decision in Neurim. According to the Court the text of Article 3(d) of the SPC Regulation is clear: the MA on which the SPC is based must be the first MA for marketing of the product. Both MAs relate to the same product, i.e. ciclesonide. For the interpretation of first MA it is irrelevant whether the MA has been granted for human or veterinary use. The SPC application for Aservo was correctly rejected. The Court concludes that the legal framework, as clarified by the CJEU, leaves no room for a broader interpretation and considers the matter an acte éclairé. There is no need refer the case to the CJEU for preliminary questions. Conclusion When assessing the meaning of first MA, as mentioned in Article 3(d) of the SPC Regulation, it is irrelevant to make a distinction between an MA granted for human or for veterinary use. If the active ingredient is the same, they both relate to the same product. The NL decision does not stand alone. Some of the courts in other EU states have followed the same line of reasoning when dealing with Boehringer’s SPC applications for Aservo. In France, the French Patent Office refused to grant the SPC, which decision was upheld by the Paris Court of Appeal on 17 January 2025. The court explicitly referred to Abraxis and Santen, confirming that a prior MA for human use precludes the grant of a subsequent SPC for veterinary use of the same active substance. In Germany, the application was likewise rejected by the German Patent and Trade Mark Office. An appeal is currently pending before the Federal Patent Court (Bundespatentgericht). Although SPCs have reportedly been granted in some other Member States, the NL Dutch Court observes that these decisions often lack explicit reasoning, may reflect different national administrative practices, and do not alter the uniform interpretation required under EU law.