Patent Term Restoration In Canada

Canada's patent term restoration regime has been up and running for over a year and a half. As of the end of April 2019, there have been 38 applications filed, and 29 granted; seven have been refused and the remainder are pending. The regime seems to be effective for those companies that are able to file their drug submissions in Canada within a year of the first filing in other major jurisdictions.

This one-year deadline is seen as the major impediment for companies that are trying to take advantage of this regime. For many larger companies, it appears that they have been able to move resources around and change their filing strategy in order to meet this deadline, however, smaller biotechnology and pharmaceutical companies do not necessarily have the resources to dedicate to filing in multiple jurisdictions before they have approval in a major market, such as the U.S. or Europe.