‘Missed opportunity’ as SPCs caught between human and veterinary medicinal products

On May 14 2025, the Administrative Chamber of the District Court of The Hague rejected Boehringer Ingelheim’s application for a supplementary protection certificate (SPC) for the veterinary medicinal product Aservo Equihaler. The case is legally significant because it mirrors – albeit in reverse – the constellation underlying the Neurim judgment by the Court of Justice of the European Union (CJEU).

Whereas Neurim allowed the grant of an SPC on the basis of a later human marketing authorisation (MA), the Dutch court refused to accept Boehringer Ingelheim’s reliance on a later veterinary MA. This raises a fundamental question: should ‘new active ingredient’ and ‘first authorisation in the EU’ be understood differently under medicinal product law and SPC law – and is such a distinction coherent in practice? While the Dutch court implicitly answered this question in the negative – grounding its reasoning, in particular, in the CJEU’s Santen ruling – this conclusion is contestable.

In 2020, Boehringer Ingelheim applied to the Dutch Patent Office (OCNL) for an SPC for the active ingredient ciclesonide. An SPC grants its holder an exclusive right, allowing the regular patent term of 20 years to be extended by up to 5½ years. It is intended to compensate the drug developer for the costly development and lengthy authorisation procedures. The grant of an SPC requires that the product:

• Is protected by a basic patent in force; and

• Has a valid MA, which must be the first authorisation to place the product on the market as a medicinal product pursuant to Article 3(d) of the SPC Regulation.

Boehringer Ingelheim based its SPC application on the 2020 MA for the veterinary medicine Aservo Equihaler. The OCNL rejected the application, reasoning that this authorisation was not the first within the meaning of Article 3(d) of the SPC Regulation, as an MA for Alvesco – a human medicinal product containing the same active ingredient – had already been granted in 2005.

Boehringer Ingelheim appealed the OCNL’s decision to the District Court of The Hague. However, the court upheld the rejection, holding that the 2005 authorisation for Alvesco constituted the first authorisation for the active ingredient and that the requirement of Article 3(d) was therefore not met.

The District Court of The Hague grounded its decision primarily on the CJEU rulings in Santen and Pharmacia. However, a closer analysis shows that neither the circumstances of those cases nor the specific reasoning applied by the CJEU can be directly transposed to the present situation.

In Santen (2020), the CJEU held that an MA for a new therapeutic indication cannot constitute a first authorisation under Article 3(d) of the SPC Regulation. The Dutch court considered this reasoning applicable in the Boehringer Ingelheim case. While there are similarities, however, a crucial distinction must be made. Santen dealt with an extension of use for an already authorised human medicinal product – a regulatory pathway that typically relies on existing data and does not require the applicant to repeat a full pre-clinical and clinical development programme.

By contrast, the veterinary authorisation at issue here required Boehringer Ingelheim to undergo an independent and resource-intensive regulatory procedure. Obtaining approval for a veterinary medicinal product involves its own comprehensive safety and efficacy assessment, including species-specific studies, new data generation, and a complete regulatory dossier. This approval is not a mere variation of an existing authorisation but a standalone MA based on full development work, regardless of whether a human medicine with the same active ingredient happens to exist.

Seen in light of the purpose of the SPC system – to compensate innovators for the time and investment necessary to obtain MAs – the situation in Santen is materially different.

In Santen, the CJEU reasoned that allowing new indications to trigger SPC eligibility would undermine the requirement of a single first authorisation for a given active ingredient. But in the present case, disregarding the extensive development costs and regulatory delays associated with a veterinary product merely because a human product was authorised years earlier does not align with the system’s compensatory rationale. Unlike in Santen, this is not an attempt to obtain additional protection for incremental therapeutic uses; it concerns a separate regulatory pathway demanding a full investment of time, testing, and resources.

The wording of the SPC Regulation reinforces this distinction. Article 3(b) refers to the MA of a veterinary “or” a human medicinal product, placing the two categories in an alternative relationship. This linguistic choice reflects a deliberate regulatory distinction: veterinary and human medicinal products are treated as separate authorisation pathways within the SPC framework.

Against this backdrop, transposing the reasoning from Santen – which concerned different indications within the same human medicinal product – to a situation involving two distinct regulatory regimes (human versus veterinary) is not appropriate. The structure of the regulation itself suggests that an authorisation in one category should not automatically negate SPC eligibility in the other.

The Dutch court also relied on the Pharmacia decision (2004) to support the view that the SPC Regulation does not differentiate between veterinary and human medicinal products. However, a closer examination reveals that the CJEU did not provide any substantive reasoning on that point.

The case did not address, let alone analyse, the implications of cross-species regulatory approvals for Article 3(d). Its relevance is therefore limited. Pharmacia cannot be taken to resolve the fundamental tension between the regulatory reality – where human and veterinary products follow distinct authorisation pathways – and the interpretation of the SPC regime in situations where an active ingredient is first approved in one species and later subjected to a full, independent approval process in another.

The court in The Hague also considered the Neurim decision (2012) to be irrelevant.

In Neurim, the company had first obtained an MA for Regulin, a veterinary medicinal product containing melatonin, and subsequently sought an SPC for Circadin, a human medicinal product based on the same active ingredient. The distinguishing feature of Neurim was thus the sequence: a veterinary authorisation preceded a later human authorisation, raising the question of whether the veterinary MA should prevent SPC protection for the human product.

The CJEU held that it should not, and tied the assessment of the first authorisation under Article 3(d) to the regulatory classification of the product as a new active substance; i.e., whether the product was entering the market for the first time in the relevant therapeutic or regulatory context.

This line of reasoning makes Neurim more comparable to the present case than the Dutch court acknowledged. Importantly, Santen did not expressly overrule the Neurim logic in situations involving cross-category authorisations (human versus veterinary). Its ruling was confined to the context of new therapeutic indications for the same human medicinal product. The broader question – whether an authorisation in one regulatory category should negate SPC eligibility for a separate, full authorisation in the other – was not addressed in Santen.

Accordingly, there are strong arguments that Neurim remains pertinent in cases such as this, where the later authorisation (here: the veterinary product) requires a complete and independent regulatory dossier, and where treating the earlier human MA as the first authorisation would conflict with the compensatory purpose of the SPC system.

The Dutch court’s decision underscores the persistent uncertainty surrounding the interface between MA rules and the SPC regime. Given the unresolved questions – particularly regarding how cross-category authorisations (human versus veterinary) should be treated under Article 3(d) of the SPC Regulation – a reference to the CJEU would have been both appropriate and desirable to promote uniform interpretation across the union. The court, however, declined to take this step, leaving an important legal gap unaddressed.

For practitioners, this reinforces the need to monitor national and European case law closely, as divergent approaches are likely to continue emerging until further guidance is provided at EU level.

For pharmaceutical companies, the practical implications are significant. The decision suggests that investments made in regulatory pathways beyond the initial human authorisation may fall outside the scope of SPC compensation – even where these pathways require extensive additional studies, data generation, and full compliance with a separate regulatory framework.