PATENT TERM EXTENSION AND THE SUPPLEMENTARY PROTECTION CERTIFICATE : Does the current approach to the regulatory regime provide adequate protection for combination drugs?

Abstract

The term of a patent is an essential feature of the patent system. This feature is arguably even more essential in the area of pharmaceutical patents, burdened with inherent formalities delaying a product’s arrival on the market. The inability for pharmaceutical patents to exercise their exclusive rights for an effective duration has a negative knock-on effect on the research and development for innovative drugs, which in turn, impinges on public health and society at large. Thus, the European Community has sought to address these issues with a supplementary protection certificate (“SPC”), which essentially prolongs the effective lifespan of a patent. However, recent case law shows that national courts are applying diverging approaches when it comes to combination drugs, leading to heterogeneity within the Community. Most recently, the Court of Justice of the European Union (“CJEU”) produced an Opinion on the joined cases of C-322/10 and C-422/10 Medeva BV and Georgetown et al. v Comptroller-General of Patents (“Medeva et al.”) and posed an approach which would make it easier for combination drugs to obtain an SPC. However, it also limited the grant of such to one SPC per patent. The effect of this on combination drugs is potentially damaging as it could serve to undermine the development of combination vaccines and hinder the possibility for immunisation against multiple diseases, particularly for babies. The CJEU currently has an opportunity in its upcoming preliminary ruling on Medeva to create a degree of uniformity in the approach of granting SPCs for combination drugs. Whether they follow the approach presented by the Advocate-General in Medeva et al. will be most interesting for those affected by pharmaceutical patents. This thesis explores the policies behind the regime, the competing interests at stake, and the differing approaches by the courts and their effects on different scenarios of combination drugs, in order to examine the current adequacy of the regulatory regime in relation to combination drugs. In particular, it focuses on the recent approach posed by the Advocate-General in Medeva et al. and examines the adequacy of such in light of combination drugs.