SPC Regulation, Analysis of SPC Case Laws and Roadmap for Pharmaceutical Industry

The purpose of the study is to understand Supplementary Protection Certificate (SPC) regulations associated with pharmaceutical products. In this study the case laws associated with SPC regulation and decisions handed down by national IP courts across Europe have been reviewed. On one hand, this study provided insights into innovator strategies in managing product lifecycles and on the other hand, it also helped in studying perspective of generic drug industry. A survey amongst IP experts about SPC regulation have also been carried out. It is observed that there is a need to amend the SPC regulation to provide better clarity to both innovators and generic drug industry.