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 Umesh 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

This article is an attempt to quantify and compare number of SPCs granted, filed and invalidated in five important European Countries UK, France, Germany, Italy and Spain. The data is collected for those patents having expiry in between 1 January 1995 till 31 December 2025. The article further focuses on recent case laws evolved in Europe and its impact on SPC filings. The analysis reveals that patentees are inclined to file more SPCs on product patents as lesser percentage of SPCs for product patent got invalidated. There is a decline in SPCs for patents on combination product. In contrast patents on composition seems to drive highest number of SPC applications as patent holders are trying to extend the life cycle of the product through follow on products, improved articles. It will be interesting to see how the trend of SPC filing will change in future after rise of Unitary Patents.

Keywords

Medeva, Actavis, SPC, Combination Patent, Sanofi, Lilly, CJEU, Carrier Protein, Markush Claims.

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Archna Roy ¹, Mayur Kardile ¹, Manthan Janodia ²

Affiliations
1 Intellectual Property Management Group, Lupin Limited, Survey No. 46A/ 47A, Nande Village, Taluka Mulshi, 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

As a result of Comprehensive Economic and Trade Agreement (CETA), for the first time, on 21 September 2017, Canada introduced Certificate of Supplementary Protection (CSP) regime. Before CETA was executed, Canada was the only country of G7 (Group of 7) countries not to legislate Patent Term Extension (PTE). This new regime is an important moment for the Canada’s intellectual property (IP) framework. On one hand, this regime provides an opportunity to innovators of pharmaceutical and veterinary products to recover investments made to obtain marketing authorizations for medicinal products, and on other hand, it impacts the timing of entry of generic products in the Canadian market. This article provides comprehensive information regarding the Canadian CSP and its comparative analysis with United States of America and Australian PTE and European Supplementary Protection Certificate (SPC).

Keywords

Certificate of Supplementary Protection, Patent Term Extension, Supplementary Protection Certificate, Comprehensive Economic and Trade Agreement, TRIPS, Canadian Patent Act, Notice of compliance, Patent Term Adjustment, Regulatory Review Period, Investigational New Drug, Investigational Device Exemption, New Drug Application, Biologic License Application, Pre-Marketing Authorization, United States Food And Drug Administration, Therapeutic Goods Administration, Australian Register of Therapeutic Goods, Australian Patent Act, 1990, The Court of Justice of the 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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