The “first marketing authorization” under Article 3(d) SPC (Part 2/2): Regulatory autonomy, Neurim, and the limits of a purely product-based approach

This second contribution completes the analysis developed in Part 1. Building on the product-centred reasoning adopted by the District Court of The Hague, it examines the limits of that approach in light of regulatory autonomy, the purpose of the SPC regime, and the scope of the Court of Justice’s case law. As in the first part, this commentary is co-authored with my friend and colleague Marco Stief.

I.               Regulatory autonomy and duplicated investment

At a deeper level, the dispute before the Hague Court reveals two competing interpretative models of Article 3(d) of the SPC Regulation. A strictly product-centred approach focuses exclusively on the existence of a prior authorization for the same active ingredient, thereby favoring formal uniformity and legal certainty. By contrast, a functional interpretation, informed by the purpose of the SPC system, considers whether the authorization relied upon corresponds to a genuinely new regulatory and economic investment. The choice between these models largely determines the outcome of cases such as the present one.

The Dutch court also referred to two judgments of the European Court of Justice. First, it referred to the Santen decision.1 This case concerned the granting of an SPC for a medicinal product for human use that was already authorized for the treatment of another therapeutic indication. The ECJ refused to grant the SPC and ruled that a new therapeutic use of a known active ingredient does not constitute a “first marketing authorization” within the meaning of Article 3(d) of the SPC Regulation if a previous authorization for another therapeutic use has already been granted for that active ingredient.

The District Court of The Hague acknowledged that the decision in question concerned different therapeutic indications and did not relate to different types of authorization, i.e., human versus veterinary medicinal products. Yet, it is considered the reasoning developed in that case as being transferable to the present case. However, one could argue that the present case concerns independent, full authorization procedures, whereas the Santen decision concerned the granting of an SPC for a new therapeutic use of an active ingredient that was already known and authorized for other indications. The apparent tension between Neurim and Santen should not be overstated. While Santen undeniably restricted the expansive interpretation of Article 3(d) adopted in Neurim, it did so in a context of incremental innovation within a single regulatory framework, namely the extension of an already authorized active ingredient to a new therapeutic indication. By contrast, Neurim concerned a situation in which the same active ingredient was subject to two autonomous regulatory assessments, each requiring a full authorization procedure. The present case aligns more closely with that scenario, as the veterinary authorization relied upon did not build upon, nor benefit from, the prior human authorization. Extending the restrictive logic of Santen to such situations risks conflating incremental therapeutic innovation within a single regulatory framework with genuine regulatory pluralism requiring separate authorization procedures.

The court in The Hague also referred to the Pharmacia decision, which should show that the SPC Regulation does not distinguish between human and veterinary medicinal products.2   However, a closer analysis of this decision shows that the ECJ did not take a position in Pharmacia on the question of whether the active ingredient contained in the first human medicinal product authorization qualifies as “new” within the meaning of the SPC Regulation. Rather, the ECJ conceptually based the first marketing authorization for human medicinal products on the “further use” of an already authorized veterinary medicinal product. However, whether an active ingredient is authorized for the first time as a veterinary or human medicinal product or whether there is merely an additional therapeutic use is a significant difference. The Pharmacia decision cannot therefore be relied upon in the present context.3

In contrast, the Dutch court expressly distanced itself from applying the ECJ ruling in Neurim.4 The ruling handed down in 2012 has the most similarities to the present case in terms of the legal reasoning. Neurim Pharmaceuticals had already obtained a marketing authorization for the veterinary medicinal product Regulin^® containing the active ingredient melatonin, in 2001. In 2007, Neurim was granted a marketing authorization for the corresponding human medicinal product Circadin^®, which is also based on a melatonin formulation—at a time when the patent for the active ingredient melatonin contained in both medicinal products had a remaining term of less than five years. Neurim therefore applied for SPCs in the European Union to extend the patent protection. However, the competent UK Intellectual Property Office (UKIPO) rejected the application on the same grounds as the court in The Hague: there was no “first marketing authorization” within the meaning of the SPC Regulation, as the same active ingredient had already been approved—namely for Regulin^®.

Neurim Pharmaceuticals lodged an appeal against the UKIPO’s decision with the High Court of Justice (EWHC), which referred the case to the European Court of Justice (ECJ) for a preliminary ruling. In its judgment of 19 July 2012 (C-130/11—Neurim), the ECJ ruled that the SPC Regulation should not be interpreted as meaning that an earlier authorization of a veterinary medicinal product fundamentally precludes the granting of a SPC for a medicinal product for human use. Rather, the decisive factor is whether the underlying patent protects a new therapeutic application of a known active ingredient for which a separate authorization procedure had to be completed. The regulatory assessment of an active ingredient as “new” was thus transferred to the assessment of the product covered by an SPC as a first placement on the market. With this teleological interpretation, the ECJ overturned the previously restrictive practice and placed the amortization considerations of the SPC Regulation at the forefront. Neurim thus marked a significant opening of the SPC regime in favor of innovative therapeutic applications.

However, the court in The Hague found that this decision had since been superseded by more recent ECJ case law, namely the judgment in the Santen case. This is correct insofar as the decision deals with secondary authorizations for new indications. However, in view of the dissimilar subjects of the decisions, it does not appear compelling to apply the reasoning developed in Santen to the present constellation of different authorization procedures.

Basing its argument on the extremely inconsistent decision-making practice concerning this field in the individual Member States of the European Union, Boehringer requested, in the alternative, that the present case be referred to the European Court of Justice. However, the court in The Hague saw no need for clarification and considered that the matter was sufficiently clarified in the existing case law (acte éclairé) and therefore saw no need to make a reference to the Court of Justice under Article 267 TFEU. In its reasoning, the court referred to the decisions of the ECJ in the Santen and Pharmacia cases. Even assuming that the District Court was not formally obliged to refer the matter to the Court of Justice, the persistent divergence in national case law and the unresolved interaction between SPC law and regulatory classifications arguably justified a request for guidance, in order to ensure a uniform interpretation of Article 3(d) across the Union.

II.             Purpose of the SPC Regulation and systemic coherence

The decision of the District Court of The Hague is not entirely convincing. The ECJ decisions cited by the court—in particular Santen and Pharmacia—are not directly transferable to the constellation of different authorization procedures for human and veterinary medicinal products at issue here. Rather, both judgments concern the question of secondary authorization of a new therapeutic indication for an already approved active substance and thus a different legal context. They do not resolve the distinct question of how Article 3(d) should operate where two full and independent authorization procedures coexist for the same active substance.

More broadly, the present dispute highlights an unresolved question of Union law: whether the concept of “first marketing authorization” under Article 3(d) must be assessed in isolation from the regulatory framework governing the authorization relied upon, or whether the autonomy and substance of that framework may be taken into account. Neither Santen nor Pharmacia squarely addressed this issue, leaving room for divergent national interpretations.

The unconditional rejection of the Neurim ruling does not appear to be compelling in this context. Although Neurim was largely overturned by Santen, it remains unclear whether the restrictive interpretation developed there should also apply to cases in which—as here—two independent, full authorization procedures were carried out. The specific situation in which a veterinary medicinal product is authorized as a new active substance even though a human medicinal product with the same active ingredient already exists was not the subject of either Santen or Pharmacia.

Instead, both the ECJ’s decision in the Neurim case, which is comparable to the present case, and the methodology and purpose of the SPC Regulation justify a correlational approach between the assessment under marketing authorization law and that under SPC law as to whether a “new” product is being placed on the market for the first time. Disregarding the regulatory delay and cost inherent in veterinary authorization procedures risks depriving the SPC mechanism of its economic justification in precisely those cases where regulatory investment is duplicated.

The Halozyme case currently pending before the European Court of Justice (Case C-456/245) also shows that there is still considerable uncertainty regarding the interpretation of specific provisions and terms in this field, particularly with regard to the relationship between marketing authorization law and SPC law and the interpretation of the terms “active ingredient” and “product” in the SPC Regulation, illustrating the continuing uncertainty surrounding the interaction between SPC law and regulatory classifications.

Against this background, a referral to the ECJ would have been appropriate in order to clarify the scope of the principles developed in Santen and to harmonize the hitherto divergent decision-making practice across the EU. Until such clarification is provided, it remains unclear whether the interpretation of Article 3(d) of the SPC Regulation should also be limited in cases of separately granted marketing authorizations for human and veterinary medicinal products to the same extent as for cases of a mere secondary indication of an already authorized active ingredient.

As long as the questions raised have not yet been conclusively clarified by the European Court of Justice, applicants for a SPC should be prepared for corresponding legal disputes. It is advisable to evaluate the EMA’s European assessment reports at an early stage and to work out in detail the classification of the active substance as a new active substance. If the authorization is granted as a human or veterinary medicinal product, the exclusivity between the two types of medicinal products should already be legally justified at this stage in accordance with Art. 3 (b), (d) SPC Regulation. Parallel proceedings in different Member States should be carefully documented and, where appropriate, diverging national decisions should be specifically included in the argumentation. From a strategic perspective, SPC considerations should be integrated at an early stage of the regulatory development process. Where distinct regulatory pathways coexist, applicants should anticipate potential disputes under Article 3(d) and align their regulatory and intellectual property strategies accordingly, rather than treating SPC protection as a purely downstream patent-law issue. Finally, relevant ECJ case law can be used in a differentiated manner to substantiate the transferability of the concept of “first marketing authorization” in the context of the approval procedure to the requirements for granting an SPC.

• 1ECJ GRUR 2020, 1071 – Santen SAS v Directeur général de l’Institut national de la propriété industrielle. See M. Dhenne, Arrêt Santen : la fin du début de la protection des nouveaux traitements en Europe ?, Propriétés intellectuelles 2020 n° 77, p. 6.
• 2ECJ GRUR 2005, 139 – Pharmacia Italia SpA.
• 3For more details, see: Stief, Das Produkt eines SPC – Kann ein neuer Wirkstoff ein bekanntes Produkt sein? (The product of an SPC – Can a new active ingredient be a known product?), GRUR 2025, 1343, 1347.
• 4ECJ GRURInt 2012, 910 – Neurim Pharmaceuticals.
• 5Summary of the request for a preliminary ruling of 18 June 2024 pursuant to Article 98(1) of the Rules of Procedure of the Court of Justice in Case C-456/24 Halozyme, Inc.