Journal of Intellectual Property Rights

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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