US and EU legal and regulatory update

Abstract

The Advocate-General of the European Court of Justice (ECJ) has delivered an important opinion that, if adopted by the judges of the court, would mean an extension in the availability of Supplementary Protection Certificates (SPCs) throughout the European Union (EU). In Case C-431/04 Massachusetts Institute of Technology (unreported opinion of 24th November, 2005), ¹ the Advocate-General proposed a broad interpretation of the definition of the products for which an SPC could be obtained, arguing that a `combination medicinal product' comprising an active ingredient and an excipient could be considered as a product attracting SPC protection.