The Court of Justice Recasts the EU Patent Term Extension System

Abstract

A legal framework providing for de facto patent term extension for pharmaceuticals has existed in the EU for over twenty years and a parallel one for agrochemicals for nearly fifteen.  One might therefore be forgiven for thinking that by now the major features of this system were fairly well settled.  However, the commercial importance of the products that it protects, being high value products in regulated sectors that have succeeded in securing a marketing authorisation, has meant that the system has attracted a disproportionate amount of litigation.  The means by which such extension is achieved - the Supplementary Protection Certificate regime, and which combines concepts from both patent and regulatory law – is a matter of EU law and so is ultimately interpreted by a body – the Court of Justice of the EU – whose recent judgments in this field have upset settled expectations.  The consequences of these judgments are still being worked through in the case law, but their origins lie in certain decisions made by national courts.  This article traces how this situation came about and identifies some of the uncertainties that remain in the system.