The conditions for the grant of a supplementary protection certificate (SPC) have, since the SPC Regulation entered into force in 1993, been the subject of numerous national decisions as well as a multitude of judgments by the CJEU. This is due not least to the enormous economic significance of SPCs, which often protect products with annual sales in the billions and can thus be decisive for the success or failure of a medicinal product. In his article, Marco Stief analyses and discusses a recent decision of the Administrative Law Division of the District Court of The Hague, which rejected Boehringer’s application for the grant of an SPC for the veterinary medicinal product Aservo® EquiHaler. The case is particularly interesting from a legal perspective because it presents parallels to the well-known Neurim judgment of the CJEU. The decision therefore once again raises the question whether the terms “new active substance” and “first authorisation in the Community” must be interpreted differently under medicinal product law and SPC law, or whether a uniform approach is required.
