CJEU to Rule on Critical SPC Patent Protection Case for Veterinary Drug Development
核心洞察
The German Federal Patent Court has referred a pivotal case to the Court of Justice of the European Union (搜索) regarding supplementary protection certificates (SPCs) for veterinary medicines containing previously approved human drug ingredients.
Boehringer Ingelheim seeks SPC protection for its ciclesonide-based veterinary product Aservo EquiHaler (搜索), despite Covis Pharma (搜索)'s prior 2005 approval of the same active ingredient for human asthma (搜索) treatment.
The CJEU ruling will determine whether separate SPC protections can be granted for human and veterinary uses of the same active substance, potentially impacting pharmaceutical innovation incentives across Europe.
The Court of Justice of the European Union (搜索) (CJEU) will soon decide a landmark case that could reshape how pharmaceutical companies obtain patent protection for veterinary medicines containing active ingredients previously approved for human use. The German Federal Patent Court has referred the case following Boehringer Ingelheim's challenge to secure supplementary protection certificate (SPC) coverage for its veterinary ciclesonide product.
The Ciclesonide Dispute
In December 2013, Boehringer Ingelheim filed European Patent EP 2 934 479 for "Ciclesonide for the treatment of airway disease (搜索) in horses." Following clinical trials, the company received market authorization for its product Aservo EquiHaler (搜索) in January 2020. The European Medicines Agency (搜索) classified it as a new active ingredient under Article 3(2)(a) of Regulation (EC) No 726/2004, marking the first veterinary drug containing ciclesonide.
However, the situation became complicated by prior approvals. Covis Pharma (搜索) had already received approval for ciclesonide in 2005 for treating human asthma (搜索), marketing its product under the brand name Alvesco. When Boehringer Ingelheim applied to the German Patent and Trademark Office (搜索) (DPMA) for an SPC in June 2020, the office rejected the application, citing the 2005 market authorization for Alvesco.
Regulatory Framework Conflict
The DPMA argued that a "first authorization" under Article 3(d) of Regulation (EC) No 469/2009 must be examined in relation to the active substance, not the product's therapeutic use. According to this interpretation, it is irrelevant that the authorizations relate to human versus veterinary medicinal products.
Boehringer Ingelheim contested this position, asserting that Article 3(b) of the SPC Regulation requires separate consideration of authorizations under different directives - Directive 2001/83/EC for human medicines and Directive 2001/82/EC for veterinary medicines. The company argued that "first authorizations" for human and veterinary uses should be distinguished, particularly since regulatory law considers an active ingredient with prior human approval as a new ingredient when later granted veterinary authorization.
Legal Precedent and International Variations
The German Federal Patent Court is not the first to address this issue. In May 2025, the Dutch Court of Appeal ruled that any prior marketing authorization for the same active ingredient precludes SPC grant, confirming a previous Dutch Patent Office decision. The Dutch court referenced the CJEU ruling in the Santen eye drop case (C-673/18), which clarified that patent offices cannot grant SPCs for new medical uses of existing products.
However, the landscape remains fragmented across Europe. While SPCs were denied in France and The Netherlands for similar applications, an SPC was granted in Czechia, highlighting the need for uniform interpretation of European law.
Clinical Development Requirements
The case highlights significant differences in regulatory requirements between human and veterinary medicine development. The authorization process for veterinary use requires new, comprehensive, and independent clinical studies, even when the same active ingredient has prior human approval. Data from human medicine applications under Directive 2001/83/EC typically cannot be used in veterinary medicine applications under Directive 2001/82/EC.
Court's Preliminary Position
The German Federal Patent Court's referral decision favors Boehringer Ingelheim's position. The court emphasized the different legal requirements for market authorization of human and veterinary medicinal products and agreed that the SPC Regulation's purpose requires distinguishing between human and veterinary market authorizations. The inability to transfer clinical data between human and veterinary applications further supports this distinction.
Industry Implications
SPCs represent crucial intellectual property rights in the pharmaceutical sector, extending patent protection for up to five years. The CJEU's decision will significantly impact pharmaceutical companies' strategies for developing veterinary applications of existing human medicines. A favorable ruling could provide stronger incentives for veterinary drug development by ensuring separate patent protection pathways.
The German Federal Patent Court noted that its position "contributes to closer integration of human and veterinary medical research and provides an incentive for corresponding developments." For companies with similar pending applications, the court advised against delaying SPC applications while awaiting the CJEU decision, as delays could result in losing protection opportunities through time limitations.
Legal Representation
Patent attorney Bianca-Lucia Vos of Hoffmann Eitle (搜索) represents Boehringer Ingelheim alongside Klemens Stratmann at the German Federal Patent Court. The team collaborated with Boehringer Ingelheim's Global Head Animal Health Patents Friederike Heckmann and received advice from medical lawyer Christian Stallberg of life sciences boutique Novacos on authorization issues.