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<.0001). Using first global patent filing dates, overall development time went from a mean of 4481 days (95% CI: 3053, 5908) in 2009 to 6298 days (95% CI: 4839, 7756) in 2018 (ANOVA, P=.0118). There was a statistically significant difference in the overall development mean time between small molecule drugs (3553, 95% CI: 3361, 3746) and biologics (3903, 95% CI: 3595, 4212), (t test, P=.0487) when using Canadian patent filing dates but not when first global patent filing dates were used. There was no statistically significant change in overall development time among drugs that were substantial, moderate or little to none additional therapeutic value compared to existing drugs. Out of 238 drugs, 218 (91.6%) would have been eligible for patent term extension with 195 (80.7%) eligible for the full 2 years. Patent term extension does not appear to be justified based on changes in overall development time, except possibly in the case of biologics. There are also trade offs in terms of increased expenditures that need to be considered if patent terms are lengthened.
Highlights
Since 1989, pharmaceutical drugs in Canada have been protected by patents for a 20 year period from the date when the patent is filed.[1]
The 1984 Hatch-Waxman Act in the United States provides for an extension by an amount equal to half the time spent in clinical trials plus the full time of Food and Drug Administration (FDA) review up to a total of 5 years or a maximum of 14 years after FDA approval, whichever is shorter.[4]
Certificate of Supplementary Protection (CSP) are available for both small molecule drugs and biologics, drugs produced from living cells, but only one CSP is allowed for a given medicine.[12]
Summary
Since 1989, pharmaceutical drugs in Canada have been protected by patents for a 20 year period from the date when the patent is filed.[1]. In the United States, the time between patent filing and approval for marketing is a median of 12.1 to 12.4 years; the difference in estimates comes from different sources used to determine patent filing dates.[3] The 1984 Hatch-Waxman Act in the United States provides for an extension by an amount equal to half the time spent in clinical trials plus the full time of Food and Drug Administration (FDA) review up to a total of 5 years or a maximum of 14 years after FDA approval, whichever is shorter.[4] Pharmaceutical patents in the European Union can be extended by a maximum of 5 years through supplementary protection certificates.[5] Innovative Medicines Canada, the lobby group representing the research-based pharmaceutical companies, and its predecessors have been advocating for at least two decades for an increase in patent life to compensate for the time that drugs spend in the overall development process (time from when the patent is filed until the drug is approved).[6,7,8,9,10,11] patent extension has only existed in Canada since September 2017 as a result of a provision in the Comprehensive Economic and Trade Agreement between Canada and the European Union. CSPs are available for both small molecule drugs and biologics, drugs produced from living cells, but only one CSP is allowed for a given medicine.[12]
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