IMpact of CETA on Canadian pharmaceutical patent law

Topics: Patent, Patent application, Generic drug, Patent law / Pages: 37 (9156 words) / Published: Jan 26th, 2014
Misha Benjamin

Potential Impact of CETA on Canadian Patent Law

CML 3351 – Directed Research
University of Ottawa
Law Faculty, Common Law Section

Paper presented to
Professor Elizabeth Judge

Submitted December 16, 2001
Ottawa, Ontario Potential Impact of CETA on Canadian Patent Law
Table of Contents
1.0 Introduction 3
1.1 Patent Rights – A Balancing Act 3
1.2 Financial Impact of Pharmaceutical Patent Rights 4
1.3 Paper Outline 5
2.0 Current State of the Law 6
2.1 Qualifying for a Pharmaceutical Patent 7
2.1.1 Appropriate Subject Matter 8
2.1.2 Novelty 10
2.1.3 Usefulness 10
2.1.4 Non-Obviousness 12
2.2 Exclusive Commercial Rights Term 13
2.3 Notice of Compliance (NOC) Regulations 14
2.3.1 Applying for a NOC 14
2.3.2 Notice of Allegation 16
2.3.3 Evergreening 17
2.3.3 Damages granted under the NOC regulations 19
2.3.4 Data Protection 19
2.4 Patented Medicine Prices Review Board (PMPRB) 21
3.0 Potential Impact of CETA 22
3.1 On Patent Term Extensions 22
3.2 On Data Protection 25
3.3 On Rights of Appeal 27
3.4 On Border Issues 29
4.0 Summary and Conclusions 31
Bibliography: 35

1.0 Introduction
This paper begins by examining how current Canadian Patent Law and Health Canada regulations together affect the important issue of commercial exclusivity granted to new brand-name drugs. It then assesses the potential impact of the currently negotiated Free Trade Agreement with the EU on Canada’s pharmaceutical patent protection regime.

1.1 Patent Rights – A Balancing Act
The are two conflicting views surrounding the issue of granting patent rights: (1) one that considers that innovators should be rewarded with patent rights because it encourages innovation and its sharing, and thus, in the end, benefits society as a whole, and (2) the other is that assigning monopoly status through patent rights operates against an open and free market economy preventing competition and diminishing the



Bibliography: 4. Eli Lilly Canada Inc. v Novopharm Limited (2010) FCA 197 5. Hatmaker v Joseph Nathan & Co Ltd 6. Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), (1999) F.C.A 7. Pfizer Canada Inc 8. Pfizer Canada Inc. v. Mylan Pharmaceuticals, (2011) FC 547 9. Ratiopharm inc 10. Re Wellburtin SR Direct Purchaser Antitrust Litigation, US District Court (ED Pen 2004) (no 04-5525) 11. Tennessee Eastman Co 4. Industry Canada “A Study on the Patent Law Standard of Non obviousness” (1996) 5. Daniel J 14. Padmanabha Ramanujam, “Justification of Intellectual Property Rights: A Game Theory Perspective” (2006). Available at SSRN: http://ssrn.com/abstract=980509 Last viewed 1/12/11 15. PMPRB “2010 annual report of the Patented Medicine Prices Review Board” 16. Suzanne Scotchmer, “Standing on the Shoulders of Giants : Cumulative Research and Patent Law” (1991) Journal of economic perspectives, Volume 5, Number 1 – Winter 1991, pages 29-41 Websites:

You May Also Find These Documents Helpful

  • Patent Law
  • Patent Law
  • CETA
  • Patent Law
  • The Law on Patent
  • Indian Patent Law
  • The Impact of Business Patent Methods
  • Patent
  • Influences on Canadian Law
  • Cases in Canadian Law