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


Affiliations
1 Intellectual Property Management Group, Lupin Limited, Nande Village, Pune, Maharashtra - 412 115, India
2 Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka - 576 104, India
 

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.

Keywords

SPC, Court of Justice for European Union, First Marketing Authorization, European Economic Community, Pediatric Extension, European Free Trade Association, New Chemical Entity, Pediatric Implementation Plan, Patent Term Extension, European Commission, Unitary Patent System, Patent Term Adjustment, Unified Patent Court System, One Product-Multiple Extension, One Patent-Multiple Extension.
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  • SPC Regulation, Analysis of SPC Case Laws and Roadmap for Pharmaceutical Industry

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Authors

Omkar Joshi
Intellectual Property Management Group, Lupin Limited, Nande Village, Pune, Maharashtra - 412 115, India
Archna Roy
Intellectual Property Management Group, Lupin Limited, Nande Village, Pune, Maharashtra - 412 115, India
Manthan Janodia
Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka - 576 104, India

Abstract


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.

Keywords


SPC, Court of Justice for European Union, First Marketing Authorization, European Economic Community, Pediatric Extension, European Free Trade Association, New Chemical Entity, Pediatric Implementation Plan, Patent Term Extension, European Commission, Unitary Patent System, Patent Term Adjustment, Unified Patent Court System, One Product-Multiple Extension, One Patent-Multiple Extension.

References