The German Federal Patent Court has asked the Court of Justice of the European Union (CJEU) to resolve a fundamental question at the intersection of human and veterinary pharmaceutical regulation: Can a veterinary medicine authorisation qualify as the “first authorisation” for Supplementary Protection Certificate (SPC) purposes when the same active ingredient was authorised years earlier for human use?
The referral arises from conflicting approaches across EU member states and highlights the broader uncertainty in how Article 3(d) of Regulation (EC) No. 469/2009 should apply when an active ingredient transitions between human and veterinary applications.
The German Federal Patent Court in 14 W (pat) 28/23 has sought a preliminary ruling from the CJEU regarding the requirements for issuing SPCs for medicinal products. The case centres on whether a prior authorisation for a human medicine prevents the grant of an SPC for a later veterinary medicine containing the same active ingredient.
Basic Patent: Ciclesonide for Equine Respiratory Diseases
The dispute involves SPC application 12 2020 000 027, which is based on basic patent EP2934479 (German file no. DE 60 2013 043 970). The basic patent, titled “Ciclesonide for the treatment of airway disease in horses” was filed by Boehringer Ingelheim Vetmedica GmbH in 2013. Claim 1 as granted relates to ciclesonide or a pharmaceutically acceptable salt thereof, or a composition comprising the same, for use in a method of treatment airway disease in equines.
Aservo® EquiHaler®: A New Veterinary Application
Boehringer Ingelheim Vetmedica GmbH conducted independent clinical trials for ciclesonide to treat equine asthma. Based on these studies, Boehringer Ingelheim Vetmedica GmbH received veterinary marketing authorisation (in accordance with Directive 2001/82/EC) for the product Aservo® EquiHaler® in 2020. Because this was the first time the substance was authorised for veterinary use, the European Medicines Agency (EMA) classified ciclesonide as a “new active substance” within the meaning of Article 3(2)(a) of Regulation (EC) No. 726/2004.
DMPA’s Rejection of SPC Application
The German Patent and Trade Mark Office (DMPA) rejected the application for an SPC in May 2023. The rejection was based on Article 3(d) of Regulation (EC) No. 469/2009 (hereafter the SPC Regulation), which requires that the marketing authorisation be the “first authorisation” for the product as a medicinal product. The DMPA cited a 2005 authorisation for ciclesonide as a human asthma treatment granted to a different manufacturer, arguing that under the CJEU’s Santen ruling (C-673/18), the first authorisation is determined by the active ingredient itself, regardless of whether it is for human or veterinary use.
Boehringer Ingelheim’s Appeal
Boehringer Ingelheim appealed the decision of the DMPA to refuse its application for an SPC.
Boehringer Ingelheim argued that the DMPA did not take sufficient account of the fact that Article 3(b) of the SPC Regulation requires that the product, as a medicinal product, has been granted a valid marketing authorisation in accordance with directive 83/2001/EC (medicinal products for human use) or Directive 82/2001/EC (veterinary medicinal product). In this context, the same standard should be applied as in the authorisation procedure to determine whether a valid authorisation pursuant to Article 3(b) of the SPC Regulation exists for the active ingredient of a medicinal product and whether it is the first authorisation pursuant to Article 3(d) of the SPC Regulation.
Boehringer Ingelheim also contended that the meaning and purpose of SPCs argue in favour of a strict separation between authorisation under veterinary and human medicinal product law.
Finally, Boehringer Ingelheim argued that in the CJEU’s Neurim decision (C-130/11), the Court found the existence of an earlier veterinary medicinal product authorisation did not preclude the granting of a SPC on the basis of a subsequent human medicinal product. Boehringer Ingelheim continued that the CJEU did not deviate from this finding in the subsequent Santen decision. In that case, it was merely decided that a SPC for a medicinal product for human use could not be granted on the basis of an authorisation for a new therapeutic use of an active ingredient if the active ingredient had already been authorised for another therapeutic use as a medicinal product for human use.
German Federal Patent Court Referral to the CJEU
The German Federal Patent Court tended to agree with the arguments forwarded by Boehringer Ingelheim. However, it noted that while the Boehringer Ingelheim had successfully obtained SPCs for this invention in several EU member states (including Austria, Bulgaria, Greece, Cyprus, Czech Republic, Estonia, Latvia, Malta, Slovenia and Italy), applications were rejected by courts in France and the Netherlands. The German Federal Patent Court considered there to be a risk of further divergent decisions within the EU.
Given this significant lack of uniformity across the EU, the German Federal Patent Court considered it necessary to refer the following question on the matter to the CJEU:
Is Article 3(d) of Regulation (EC) No. 469/2009 of the European Parliament and of the Council of May 6, 2009, concerning the supplementary protection certificate for medicinal products to be interpreted that the marketing authorization for a product as a veterinary medicinal product in accordance with Directive 2001/82/EC is the first marketing authorization for that product as a medicinal product, even if a marketing authorization for the same active substance as a medicinal product for human use has previously been granted in accordance with Directive 2001/83/EC?
The CJEU’s interpretation of “first authorisation” has the potential to influence future pipelines, market strategies and long-term IP planning across the veterinary sector. The CJEU’s ruling will help clarify whether innovators developing veterinary medicines can obtain SPC protection even where the active ingredient has long been authorised for human use. We will continue to monitor this referral closely as it progresses.
How we can help
If you have questions about how this referral may affect your SPC strategy, our attorneys are available to help. Get in touch with the Secerna team to discuss the implications for your products and future filings.