Supplementary protection certificates: still a grey area?

Abstract

Supplementary Protection Certificates (SPCs) were introduced in 1992, and have since been considered a very valuable tool for the pharmaceutical industry, allowing for market prolongation and compensating for the effective patent protection time lost in the process of market authorization. Over the past five years, numerous Court of Justice of the European Union (CJEU) rulings have attempted to interpret the provisions of EU Regulation 1901/2009 and provide clarity to patent holders as well as generics manufacturers as to the protection requirements and the scope of protection awarded. This article analyses the implication of major CJEU cases concerning the interpretation of Articles 3(a), 3(d) and 1(b) of the Regulation. The article also discusses the interrelation between the EU SPC Regulation, on the one hand, and the Market Authorization Regulation and the Market Authorization Directive, on the other, and compares the EU system with that provided by the USA. An analysis of recent case law reveals that now, some 25 years after the entry into force of the Regulation, the system is still obscure. A serious concern also arises as to whether the system as it stands today is simply inappropriate to the protection of modern pharmaceuticals and whether this is also one of the reasons for the growing volume of case law in the field.