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


Affiliations
1 Intellectual Property Management Group, Lupin Limited, Survey No. 46A/ 47A, Nande Village, Taluka Mulshi, Maharashtra - 412 115, India
2 Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka - 576 104, India
 

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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  • http://trade.ec.europa.eu/doclib/press/index.cfm?id=1723 (accessed on 7 January 2018).

  • https://www.lexology.com/library/detail.aspx?g=66437b46-9961-455e-aacf-572f930796f2 (accessed on 7 January 2018).

  • Canadian ‘Patent Act 1985’ amended on 21 September 2017.

  • http://www.bcf.ca/en/current-affairs/829/ceta-and-phaimaceutical-patents-supplementary-protection-certificates-now-established-in-canada (accessed on 7 January 2018).

  • Certificate of Supplementary Protection Regulations, Canada Gazette Part II, Extra Vol. 151, No. 1, 7 September, 2017.

  • Section 115 of Canadian Patent Act, 1985 amended on 21 September 2017.

  • Section 118 of Canadian Patent Act, 1985 amended on 21 September 2017.

  • Section 124 of Canadian Patent Act, 1985 amended on 21 September 2017.

  • Section 123 of Canadian Patent Act, 1985 amended on 21 September 2017.

  • Section 116 of Canadian Patent Act, 1985 amended on 21 September 2017.

  • Section 104 of Canadian Patent Act, 1985 amended on 21 September 2017.

  • Section 105 of Canadian Patent Act, 1985 amended on 21 September 2017.

  • Section 106 of Canadian Patent Act, 1985 amended on 21 September 2017.

  • Section 122 of Canadian Patent Act, 1985 amended on 21 September 2017.

  • Section 114 of Canadian Patent Act, 1985 amended on 21 September 2017.

  • Section 126 of Canadian Patent Act, 1985 amended on 21 September 2017.

  • Section 127 of Canadian Patent Act, 1985 amended on 21 September 2017.

  • 35 U.S.C. § 154 and 35 U.S.C. § 156.

  • https://www.accessdata.fda.gov/scripts/cder/ob/search_patent .cfm (07 January 2018).

  • http://www.griffithhack.com/news/2017/swiss-type-claims-not-eligible-for-patent-term-extension-in-australia/ (accessed on 7 January 2018).

  • Section 70 to 79 A of the Australian Patents Act, 1990.

  • Alphapharm Pty Ltd v HLundbeckA/S [2014] FCA 1185.

  • Commissioner o f Patents v Abb Vie Biotechnology Ltd [2017] FCAFC 129.

  • Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009.

  • Article 7 of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009.

  • Article 13 of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009.

  • http://www.khuranaandkhurana.com/2017/01/11/india-do-we-need-patent-term-extension-and-non-patent-exclusivities-for-pharmaceuticals/ (accessed on 11 January 2018).

  • Merck Sharp & Dohme Corporation v Deutsches Patent, (Case C-125/10), 8 December 2011.


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

Abstract Views: 310  |  PDF Views: 189

Authors

Archna Roy
Intellectual Property Management Group, Lupin Limited, Survey No. 46A/ 47A, Nande Village, Taluka Mulshi, Maharashtra - 412 115, India
Mayur Kardile
Intellectual Property Management Group, Lupin Limited, Survey No. 46A/ 47A, Nande Village, Taluka Mulshi, Maharashtra - 412 115, India
Manthan Janodia
Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka - 576 104, India

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.

References