Post by Matthieu Dhenne, PhD

Article 3(d) SPC – Human vs Veterinary MAs: back before Luxembourg An important development in SPC litigation. The German Federal Patent Court (BPatG) has stayed the ciclesonide SPC case (Aservo® EquiHaler®) and referred a preliminary question to the Court of Justice of the European Union (CJEU) (see the analysis by Thorsten Bausch, Klemens Stratmann and Bianca-Lucia Vos in the comments). The core issue: Can a veterinary marketing authorisation qualify as the “first MA” under Article 3(d) of Regulation (EC) No 469/2009 where the same active ingredient had previously been authorised as a human medicinal product? The District Court of The Hague has rejected such an approach and declined to refer. The BPatG, however, has now decided that the matter warrants clarification at EU level. With Dr. Marco Stief, LL.M. (University of Chicago), we have addressed this question in depth in two previous articles (links in the comments), examining whether Article 3(d) permits — or even requires — a differentiated assessment of human and veterinary MAs. Marco has also published on the issue in GRUR (2025, 1343), and we are currently preparing a further contribution for Propriété Industrielle Review (LexisNexis). In our view, there are strong doctrinal arguments supporting a differentiated approach. Importantly, Santen should not be read as foreclosing all Neurim-type configurations. After Neurim, the CJEU may once again be asked to define the structural boundaries of the “first MA” concept. Doctrinally delicate. Strategically significant. #ForPharmaPatentsAddicts #PatentLitigation #SPClitigation #LifeSciences