Impact Of CETA On Canadian Patent Law
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 …show more content…
This is supplemented by various Health Canada regulations in its role of overseeing the sale of drugs. These regulations include the Patented Medicines Notice of Compliance (NOC) Regulations and the Food and Drugs Act.
These laws are in part the product of amendments required to fulfil Canada’s international obligations from various negotiated free trade agreements. Two of the most influential accords entered into by Canada are the North American Free Trade Agreement (NAFTA) in 1994 and the Trade-Related Intellectual Property Rights Agreement (TRIPS) in 2001.
While the Patent Act is a general act in the sense that it covers all inventions, it does have sections that relate specifically to the pharmaceutical sector. There are 4 important aspects that fully describe the rights and issues related to pharmaceutical patents : (1) the criteria that qualifies a drug for patent consideration, (2) the right of exclusive commercialization which is the most important right granted to the patent holder (3) Health Canada’s regulatory process for safely introducing a drug into the marketplace, known as the Notice of Compliance (NOC) Regulations and finally (4) the Patented Medicine Prices Review Board (PMPRB), a quasi-judicial body whose role is to ensure reasonable pricing of protected drugs. Each aspect …show more content…
regulations, the method of computation of the extension is very favourable to pharmaceutical companies. In fact, whereas the Hatch-Waxman act grants an extension based on the length of clinical trials and delays in regulatory approval, the proposed CETA extension will be based on the period elapsed between filing for the patent and the issuance of the NOC. Because pharmaceutical companies tend to apply for patents early in the drug development process and because it generally takes an average of 11 to 13 years to bring a drug to market , this amendment will be tantamount to granting a 25-year (or 25,5 years if pediatric studies have been conducted) patent term for new drugs. Of course, as there is some room for interpretation in the proposed terms, the full impact of these changes cannot be fully assessed until it is seen how Canada will integrate these requirements in its domestic regime For example, the current text is unclear, as to whether these conditions would apply to existing
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 …show more content…
This is supplemented by various Health Canada regulations in its role of overseeing the sale of drugs. These regulations include the Patented Medicines Notice of Compliance (NOC) Regulations and the Food and Drugs Act.
These laws are in part the product of amendments required to fulfil Canada’s international obligations from various negotiated free trade agreements. Two of the most influential accords entered into by Canada are the North American Free Trade Agreement (NAFTA) in 1994 and the Trade-Related Intellectual Property Rights Agreement (TRIPS) in 2001.
While the Patent Act is a general act in the sense that it covers all inventions, it does have sections that relate specifically to the pharmaceutical sector. There are 4 important aspects that fully describe the rights and issues related to pharmaceutical patents : (1) the criteria that qualifies a drug for patent consideration, (2) the right of exclusive commercialization which is the most important right granted to the patent holder (3) Health Canada’s regulatory process for safely introducing a drug into the marketplace, known as the Notice of Compliance (NOC) Regulations and finally (4) the Patented Medicine Prices Review Board (PMPRB), a quasi-judicial body whose role is to ensure reasonable pricing of protected drugs. Each aspect …show more content…
regulations, the method of computation of the extension is very favourable to pharmaceutical companies. In fact, whereas the Hatch-Waxman act grants an extension based on the length of clinical trials and delays in regulatory approval, the proposed CETA extension will be based on the period elapsed between filing for the patent and the issuance of the NOC. Because pharmaceutical companies tend to apply for patents early in the drug development process and because it generally takes an average of 11 to 13 years to bring a drug to market , this amendment will be tantamount to granting a 25-year (or 25,5 years if pediatric studies have been conducted) patent term for new drugs. Of course, as there is some room for interpretation in the proposed terms, the full impact of these changes cannot be fully assessed until it is seen how Canada will integrate these requirements in its domestic regime For example, the current text is unclear, as to whether these conditions would apply to existing