Canada’s Patented Medicines (Notice of Compliance) Regulations: Removing Inefficiencies to Encourage Generic Competition

• Main Author: Porter, Suzanne
• Other Authors: Fadel, Mohammad
• Language: en_ca
• Published: 2011
• Subjects: patent; pharmaceutical; Notice of Compliance; Hatch Waxman; generic pharmaceutical; 0398; 0616
• Online Access: http://hdl.handle.net/1807/31388

Canada’s Patented Medicines (Notice Of Compliance) Regulations fail to achieve the intended purpose of balancing innovation with timely generic market entry. An examination of the inefficiencies created by the Canadian regulations reveals that key features of U.S. pharmaceutical law should be adopted to improve the disjointed regulatory system that impedes generic competition. Specifically, the regulations should be amended to consolidate multiple proceedings into one cause of action that evaluates patent validity. An economic incentive to challenge weak patents should also be introduced in Canada. These features encourage competition without deterring pharmaceutical research and development because only patents that are not truly inventive will be invalidated after a full inquiry. As such, the intellectual property laws will continue to satisfy Canada’s international intellectual property obligations and protect innovative medicines and allow recovery of costs and monopoly profits to new and useful pharmaceutical products.