Recent European Developments Regarding Patent Extensions (SPCs And Paediatric Extensions)

INTRODUCTION

Supplementary protection is key to the pharmaceutical industry and has now in general been made available more easily by the Court of Justice of the European Union ('the Court'). In November 2011 the court rendered judgments in two cases, and reasoned orders¹ in three more, about the interpretation of Article 3(a) and (b) of the Regulation (EC) 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products ('the SPC Regulation'). In December 2011, the court handed down an important decision that related to supplementary protection certificate ('SPCs') and paediatric extensions. And just recently, the court published its orders of 9 February 2012 regarding the scope of protection of SPCs. For easy reference, the court's late 2011 and early 2012 case law regarding SPCs is summarised in Table 1. Even though the overall effect of the decisions for the innovative pharmaceutical industry is positive, not all issues regarding