Patent decision
- BL number
- O/0600/25
- Concerning rights in
- SPC/GB20/032
- Hearing Officer
- Dr R Dinham
- Decision date
- 1 July 2025
- Person(s) or Company(s) involved
- Boehringer Ingelheim Vetmedica GmbH
- Provisions discussed
- Regulation (EC) 469/2009 (Medicinal Products), Article 3
- Keywords
- Supplementary Protection Certificates
- Related Decisions
- None
Summary
An application was filed for an SPC to protect the medicinal product Aservo® EquiHaler®-ciclesonide, which contains the active ingredient ciclesonide, specifically for use in horses. There are earlier marketing authorisations (MA) for ciclesonide for human use, as Alvesco/Freathe/Amavio 40, 80 and 160 inhalers, with an SPC granted based on earlier authorisations. As there were other earlier MAs for the product ciclesonide, the examiner considered that the MA for the medicinal product Aservo® EquiHaler® was not the first MA placing the product ciclesonide on market as a medicinal product for the purposes of Article 3(d) of the SPC Regulation. The examiner also argued that the application cannot be granted in view of Article 3(c), as ciclesonide had also been the subject of an earlier SPC.
Requesting a decision based on the papers on file, the applicant asserted that it was the intention of the SPC Regulation to distinguish between human and veterinary uses of products, because the granting of MAs was under different regulatory frameworks, and because ciclesonide obtained an MA as a “new active substance” in view of the lack of any prior veterinary authorisation for the product. They also questioned the extent to which Santen “reverses” the earlier CJEU judgment in Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents (C-130/11) (“Neurim”), such that it was not the intention of the CJEU in Santen that a prior MA for human use should be viewed as the first MA for the same active substance for veterinary use, and vice versa.
Whilst acknowledging that the term “new active substance” was important from a regulatory perspective (e.g. in terms of the safety and efficacy testing required), the hearing officer found that this term is not used in the SPC Regulation or in its Explanatory Memorandum. Whilst the CJEU in Arne Forsgren v Österreichisches Patentamt (C-631/13) stated that the term “active substance” in the human medicinal product Directive is understood as meaning “active ingredient”, the hearing officer considered that this is in the context of defining the pharmacological etc. effects of that substance, based on how actives and non-actives were understood in pharmacology; the phrase “new active substance” and its associate context was not considered.
Taking into account relevant case law where Santen has been considered, including Newron Pharmaceuticals S.p.A v Comptroller General of Patents, Trademarks and Designs [2024] EWCA Civ 128 and Merck Serono S.A. v The Comptroller General of Patents, Trade Marks And Designs [2025] EWCA Civ 45, the hearing officer found that the definition of product in the SPC Regulation did not extend to use of that product, and that there was nothing to suggest that a distinction between human use and veterinary use should be made. Therefore, the hearing officer concluded that an earlier MA for a product for human use was considered to be the first MA for the purposes of Article 3(d) of the SPC Regulation. Furthermore, the application did not meet the requirements of Article 3(c) of the Regulation due to the existence of earlier certificate SPC/GB04/026.
The application was refused under Article 10(2).
Full decision O/0600/25 
122Kb
