Evergreening exclusive rights in pharmaceutical products: the case of SPCs, paediatric extensions and orphan drugs

This chapter analyses three EU regulations that have had a major impact on the pharmaceutical industry in recent years, namely: the Supplementary Protection Regulation (Regulation (EC) 469/2009), the Paediatric Regulation (Regulation (EC) 1902/2006), and the Orphan Drugs Regulation (Regulation (EC) No 141/2000). It discusses the weaknesses in the drafting of this legislation and the grey areas that have emerged in interpreting and applying the regulations, and it presents specific illustrations from the relevant case law. The chapter argues that the lack of a coordinated view of the approach of the legislator has allowed for a certain degree of ambiguity around the scope of the exclusive rights granted, something that in turn has created scope for market abuses.