Journal of Intellectual Property Rights

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Analysis of SPC Regulation Associated with Pharmaceutical Products in Europe


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

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.

Keywords

Supplementary Protection Certificate, Patent Term Extension, Court of Justice for European Union, New Chemical Entity, European Free Trade Agreement, Ema, Generic Drug Industry.
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Abstract Views: 324

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  • Analysis of SPC Regulation Associated with Pharmaceutical Products in Europe

Abstract Views: 324  |  PDF Views: 187

Authors

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

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.

Keywords


Supplementary Protection Certificate, Patent Term Extension, Court of Justice for European Union, New Chemical Entity, European Free Trade Agreement, Ema, Generic Drug Industry.

References