Analysis of SPC Regulation Associated with Pharmaceutical Products in Europe

Abstract

The purpose of the study is to understand SPC regulations associated with pharmaceutical products. The study focuses on the case laws associated with SPC regulation and decisions handed down by national IP courts across Europe. The study also provides some guidelines for patent claim drafting with improved chances of getting and identifying avenues for challenging SPCs, as well as possible solutions and loopholes in SPC regulation. The guidelines for predictions of generic drug entry into market are discussed. The data collected and analyzed for individual European Country provides useful insight into pattern of SPC filing, grant and SPC invalidity. It is observed that there is a need to amend SPC regulation to provide better clarity to both innovators and generic drug industry.