On 14 May 2025, the Administrative Division of the District Court of The Hague (‘the Court’) rendered its decision in proceedings between Boehringer Ingelheim Vetmedica GmbH (‘Boehringer’) and the Dutch Patent Office (Octrooicentrum Nederland, ‘OCNL’). The Court upheld OCNL’s refusal to grant an SPC for a veterinary medicinal product containing the active ingredient ciclesonide. This case is of particular interest as it clarifies that, for the purpose of determining the ‘’first’’ marketing authorisation (‘’MA’’) within the meaning of Article 3(d) of Regulation 469/2009 (‘’SPC Regulation’’) , no distinction is to be made between MAs granted for human or veterinary use. The Court considered it an acte éclairé based on the CJEU’s decisions in Santen (C-673/18) and Pharmacia (C-31/03).
What preceded
Boehringer holds EP 2 934 479 (‘’EP 479), which claims the use of ciclesonide for the treatment of airway disease in horses. Boehringer markets its product under the brand name ‘Aservo’. EP 479 was granted on 19 September 2018 on the basis of an application filed in 2013. On 28 January 2020 Boehringer received the MA for its product Aservo (EU/2/I9/249).
On 30 March 2005, an unrelated company to these proceedings, Covis Pharma Europe B.V., received a MA (RVG 31633) for the medicinal product containing the active ingredient ciclesonide used to control persistent asthma in adults and adolescents (aged 12 years and older). It was marketed under the brand ‘Alvesco’.
On 22 June 2020, Boehringer filed an SPC application with OCNL based on EP 479 and its MA for Aservo. OCNL rejected Boehringer’s application, arguing that the veterinary MA could not be considered the “first MA” under Article 3(d) of the SPC Regulation in light of the earlier MA for Alvesco. Boehringer objected against that rejection. In April 2024 OCNL, declared Boehringer’s objection unfounded. Therefore, Boehringer appealed to the Administrative Division of the Court.
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.
