Comparative Analysis of Canadian ‘Certificate of Supplementary Protection’ with USA and Australian ‘Patent Term Extension’ and European ‘Supplementary Protection Certificate

Janodia, Manthan D (2018) Comparative Analysis of Canadian ‘Certificate of Supplementary Protection’ with USA and Australian ‘Patent Term Extension’ and European ‘Supplementary Protection Certificate. Journal of Intellectual Property Rights, 23. pp. 167-173. ISSN 0971-7544

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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).

Item Type: Article
Uncontrolled 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
Subjects: Pharmacy > MCOPS Manipal > Pharmacy Management
Depositing User: KMC Library
Date Deposited: 05 Mar 2019 03:46
Last Modified: 05 Mar 2019 03:46
URI: http://eprints.manipal.edu/id/eprint/153307

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