Journal of Intellectual Property Rights

Omkar Joshi ¹, Archna Roy ¹, Manthan Janodia ²

Affiliations
1 Intellectual Property Management Group, Lupin Limited, Lupin Research Park, Pune-411042, Maharashtra, IN
2 Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576104, Karnataka, IN

Abstract

New development in terms of Unitary Patent Protection (UPP) system in Europe is anticipated by the end of the year 2017. This article reviews the advantage of UPP over European Patent system (EPS). In addition, the upcoming Unified Patent Court (UPC) system allows parties to litigate in a single forum which would be time saving and cost effective. In this article we have tried to briefly summarize the structure of UPC. There are certain areas like Supplementary Protection Certificate (SPCs) relating to pharmaceutical products which may be significantly impacted by UPP and UPC. We have tried to weigh the implications of the new system on SPC and also provide some possible solutions. Lastly, Britain’s exit from European Union, popularly referred to as Brexit, may pose some challenges to the UPC and UPP and might adversely affect the fundamental purpose of a single patent system in Europe.

Keywords

UPC Agreement, SPC, Unified Patent Court, Brexit, Treaty on European Union.

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Omkar Joshi ¹, Archna Roy ¹, Manthan Janodia ²

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

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.

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Omkar Joshi ¹, Archna Roy ¹, Manthan Janodia ²

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

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.

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