Development Time and Patent Extension for Prescription Drugs in Canada: A Cohort Study.

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Author: Joel Lexchin
Date: Aug. 2021
Publisher: Kerman University of Medical Sciences
Document Type: Report
Length: 4,113 words
Lexile Measure: 1610L

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Abstract :

The Comprehensive Economic and Trade Agreement between Canada and the European Union provides for an extension of Canadian patents for prescription drugs by up to 2 years. One of the arguments advanced for longer patent time is to compensate companies for the length of the overall drug development time (the time between patent application and market approval). This study investigates overall development time in Canada for different groups of drugs approved between January 1, 2009 and December 31, 2018 and how many of these drugs are eligible for up to 2 years of patent term extension. Based on a list of patents and dates of market approval, the change in overall development time for all drugs was calculated along with whether there were differences in development time between different groups of drugs. Using Canadian patent filing dates, overall development time for all drugs went from a mean of 2240 days (95% CI: 1832, 2648) in 2009 to 4197 days (95% CI: 3728, 4665) in 2018 (analysis of variance [ANOVA], P Keywords: Biologics, Canada, Development Time, Patent Term Extension, Small Molecule Drugs

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Gale Document Number: GALE|A669377061