The “first marketing authorization” under Article 3(d) SPC (Part 1/2): The Hague decision and a product-centred reading

I am particularly pleased to publish this commentary, co-authored with my friend and colleague Marco Stief, whose earlier work on this decision provided the starting point for the present analysis, addressing the interface between human and veterinary medicinal product regulation in SPC law.

The analysis is presented in two parts. This first contribution sets out the factual and regulatory background of the case and examines the reasoning adopted by the Hague court, which relies on a strictly product-centred reading of Article 3(d) of Regulation (EC) No 469/2009. The second part will turn to the systemic limits of that approach, in light of regulatory autonomy, the purpose of the SPC regime, and the Court of Justice’s case law.

I. Facts of the case and regulatory background

In 2020, Boehringer Ingelheim applied to the Dutch Patent Office for a supplementary protection certificate (“SPC”) for the active ingredient ciclesonide, relying on the marketing authorization granted that same year for the veterinary medicinal product Aservo^® EquiHaler^®. The application was rejected on the ground that ciclesonide had already been authorized in 2005 for use in human medicinal products, with the consequence that the veterinary authorization could not qualify as the “first marketing authorization” within the meaning of Article 3(d) of the SPC Regulation.

Following an unsuccessful administrative appeal, Boehringer brought the matter before the District Court of The Hague. In its judgment of 14 May 2025, the court confirmed the refusal, holding that any prior marketing authorization for the same active ingredient—whether for human or veterinary use—precludes the grant of an SPC.

At first sight, the position adopted by the District Court of The Hague fits squarely within a literal and product-centred reading of the SPC Regulation. Article 1(b) defines the “product” as the active ingredient or combination of active ingredients, irrespective of the therapeutic indication or regulatory pathway. Article 3(d), in turn, refers to the first authorization of that product as a medicinal product in the Union, without expressly distinguishing between human and veterinary uses. From that perspective, any prior authorization for the same active ingredient may appear sufficient to preclude the grant of an SPC.

This initial observation, however, calls for a closer examination of how Article 3(d) operates within the overall architecture of the SPC regime, which combines a time-limited extension of patent protection with a strictly circumscribed definition of its material scope. An SPC grants its holder an exclusive right, whereby the regular patent term of 20 years can be extended by up to five and a half years (i.e. up to five years under the SPC Regulation, plus a possible six‑month pediatric extension where applicable). However, pursuant to Articles 4 and 5 of Regulation (EC) No 469/2009, the scope of protection conferred by an SPC is limited to the product as authorized and to the uses covered by the relevant marketing authorization. According to Art. 3 of the SPC Regulation, the prerequisites for the granting of an SPC are that, at the time of application for the SPC, the product is protected by a basic patent that is in force, a valid marketing authorization has been granted, no other SPC exists for the product and, of particular relevance in the present case, the underlying marketing authorization for the medicinal product is the first one for that product in the EU market.

In terms of regulatory approval, human and veterinary medicines are treated strictly separately and undergo different control procedures. Accordingly, the active ingredient “ciclesonide” in the veterinary medicine Aservo^® EquiHaler^® was declared and classified as a new active substance (NAS) by the European Commission within the scope of the regulatory process, although a human medicinal product containing the active ingredient ciclesonide already existed.1This regulatory “NAS” classification is primarily relevant for the regulatory exclusivity framework and does not necessarily coincide with the autonomous concept of “product” and “first marketing authorization” under the SPC Regulation. Thus, in terms of regulatory law, this constitutes the first time the product has been placed on the market in the EU. The question now is whether this assessment as “new” in the regulatory procedure can be transferred to the assessment of the first marketing of the product in the SPC granting procedure, or whether the earlier marketing of a human medicinal product prevents the granting of an SPC for a later veterinary medicinal product based on the same active ingredient.

II. Decision of the District Court of The Hague and Analysis

The District Court in The Hague rejected the transfer of the standards developed for the medicinal products approval procedure, arguing that the term “active ingredient” in the SPC Regulation is different from that [applied] under drug approval law. The sole determining criterion in assessing the first product placement on the market within the meaning Article 3(d) of the SPC Regulation, is whether an authorized medicinal product with the same active ingredient already existed, regardless of whether it was a human or veterinary medicinal product. In either case, a prior authorization would lead to a rejection of the SPC. The Court further stated that it was not incumbent upon the European Commission or the Committee for Medicinal Products for Veterinary Use to assess whether the authorization referred to in Article 3(d) of the SPC Regulation was the first one for the product ciclesonide. Only the Dutch Patent Office was competent to make that assessment.2The underlying legal issue is therefore whether Article 3(d) of the SPC Regulation requires a single, cross-sectoral assessment of “first marketing authorization”, or whether autonomous human and veterinary authorization procedures may constitute independent reference points where each entails a self-standing regulatory investment.

However, this argument would have the practical consequence that each national (patent) office could decide independently, regardless of the assessment of the competent authorizing authority, whether an authorization constitutes a “first authorization” within the meaning of Article 3(d) of the SPC Regulation. Such an interpretation would be contrary to the requirement of transparency and the objective of a uniform and harmonized application of the SPC Regulation throughout the Union. It could also undermine the uniform application of Union law by allowing identical products to give rise to different SPC outcomes and durations depending on the Member State in which protection is sought. Another argument against this view is that the SPC Regulation does indeed distinguish between human and veterinary medicinal products. Thus, Article 3(b) of the SPC Regulation explicitly refers to Directive 2001/83/EC for human medicinal products and Directive 2001/82/EC for veterinary medicinal products. Furthermore, the procedures, testing requirements and dossiers for the two types of medicinal products are strictly separated. A veterinary medicinal product must undergo its own full initial authorization procedure and cannot refer to the human medicinal product in this respect. More fundamentally, the present case should not be framed as requiring a strict ontological distinction between human and veterinary medicinal products under the SPC Regulation. Rather, it raises the question whether two regulatory pathways that are autonomous in terms of scientific assessment, data requirements, timelines and costs may legitimately be treated as independent reference points when interpreting Article 3(d). Each authorization procedure entails a self-standing regulatory investment, involving distinct safety and efficacy assessments and separate market access decisions. This regulatory autonomy, rather than the formal classification of the medicinal product, may therefore be relevant when assessing whether an authorization constitutes the “first marketing authorization” for the purposes of the SPC regime.

In addition to the wording, the purpose of the SPC Regulation also contradicts a uniform approach to human and veterinary medicinal products. The aim of the Regulation is to ensure adequate protection for the development of medicinal products and to ensure that, in particular, lengthy and cost-intensive research and development work can be recouped economically. If a veterinary medicinal product is classified as “new” under marketing authorization law, it must undergo its own testing procedure to assess its safety and efficacy, regardless of whether its active substance is already being used as an ingredient in an authorized medicinal product for human use. If the granting of a SPC were refused on the grounds that a marketing authorization for a medicinal product for human use already exists, both the delay caused by the necessary marketing authorization procedure and the associated, regularly considerable financial expenses would not be taken into account. Such an interpretation would be contrary to the idea of amortization, which underlies the protective purpose of the SPC Regulation.

At first sight, the approach adopted by the District Court of The Hague appears textually coherent and consistent with a formal, product-based understanding of the SPC Regulation. However, this reasoning also raises more fundamental questions as to whether such a purely product-centred reading can adequately account for the autonomy of regulatory pathways and the economic rationale underlying the SPC system. These issues are examined in Part 2 of this commentary.