How long do new patented medicines have market exclusivity in Canada’s public drug plans?


Author: Brett J Skinner, Ph.D.

New drugs are patented at the time that they are discovered. Patent terms in Canada are currently 20 years. However, time spent in clinical trials (testing safety and effectiveness) consumes much of the patent term for new drugs. Delays in government regulatory and reimbursement processes, as well as court decisions that invalidate patents further shorten the actual period of market exclusivity for new patented drugs, leaving far less than 20 years of actual market exclusivity when the drug is finally available to be sold for use by patients. The objective of this study is to measure the actual period of market exclusivity (in the publicly insured markets) for the new patented drugs approved by Health Canada that were covered under public drug plans in Canada during the years 2004 to 2015.