Maximizing Innovation Lifespans: Canada Patent Term Adjustment
To commit to Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada introduced Certificate of Supplementary Protection (CSP) regime in September 2017, providing up to 2 years of additional protection for drugs containing a new medicinal ingredient, or a new combination of medicinal ingredients, protected by an eligible patent. This additional protection compensated for the time spent in research and obtaining marketing authorization from Health Canada.
With over 90 issued CSPs for drugs like Semaglutide, Olaratumab, Guselkumab, etc. and 4 applications still pending for drugs like Ciltacabtagene autoleucel, Daridorexant hydrochloride, Vericiguat, etc. CSPs have provided a huge relief to the patent owners in obtaining recourse for the losses attributable to the regulatory delays.
However, until Canada-United States-Mexico Agreement (CUSMA) came into force in July 2020, there was no obligation under Canada Patent Act to compensate for unreasonable delay in the processing of patent applications by Canada Intellectual Property Office (CIPO) in the form of a Patent Term Adjustment (PTA). Now, with Bill C-47 receiving royal assent in June 2023, PTAs will come into force on January 1, 2025, and will be applicable to all Canadian patent applications filed on or later than December 1, 20201.
Any patent that faced an unreasonable delay in the patent grant is eligible for a PTA. An “unreasonable delay” includes “a delay in the issuance of a patent of more than five years from the date of filing of the application in the territory of the Party (Date A), or three years after a request for examination of the application has been made (Date B), whichever is later.” Any delay that is attributable to the patent applicant will not be considered to calculate PTA2.
The PTA will be calculated as the number of days between the later of Date A and B and the day on which the patent is issued, minus the number of days attributable to patent applicant delay.
PTAs will not be granted by the Patent office by default. The patentee is required to apply for this additional protection and pay a prescribed fee within three months of the date of issuance of patent. Consequently, a “certificate of additional term” will be issued to the patent owner mentioning the number of the patent, the duration of the additional adjustment, and any other prescribed information.
It is important to note that under the proposed legislation, the CSP and PTA terms run concurrently. The term of the CSP starts at the expiry of the basic 20-year patent term, not at the expiry of the PTA.
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