The Canadian government is proposing modifications to the Patent Rules to finally introduce a Patent Term Adjustment (PTA) system1. The PTA will provide an additional term for patents for unreasonable delays in their issuance. The PTA system is an obligation deriving from the Canada-United States-Mexico Agreement (CUSMA) that entered into force on July 1, 2020.
This new PTA system will take effect on January 1, 2025, and it will apply to Canadian patent applications filed on or after December 1, 2020 that have suffered unreasonable delays in their issuance. An unreasonable delay is defined as a delay in issuance of more than five years from the filing date or three years from the examination request date, whichever is later, with certain exclusions.
A patentee will have to file an application for PTA eligibility and duration of the additional term. PTA applications will have to be filed within three months of the patent grant, with a fee of $2,500 ($1,000 for small entities). Upon receiving the PTA application, the Canadian Intellectual Property Office (CIPO) will send a preliminary PTA determination, allowing the patentee and others two months to make observations. The CIPO will then issue a certificate of additional term or dismiss the application, explaining the decision. Additional fees will apply for requesting reconsideration of the determination for an additional term, and for maintaining the patent during the additional term.
An additional patent term will be calculated by subtracting the number of excluded days from the total delay beyond the relevant five-year or three-year benchmark. Exclusions consider delays attributable to the applicant's actions during prosecution. For example, each day the applicant takes to respond to an Examiner's Report will be considered as an applicant-induced delay resulting in exclusion to the length of the PTA.
Due to these exclusions, it is anticipated that the grant of PTAs will be rare. Notably, since the entire period of examination deferral is deducted from the PTA, the Patent Office has a minimum of five years from the examination request date to issue a patent without it qualifying for any PTA. Moreover, since applicants are not allowed any time to respond to Examiner's Reports or to pay the final fee, it will further reduce the length of the PTA.
Should an additional period be granted, the patent will expire at the end of that additional period. Thus, correlative amendments to the Patented Medicines (Notice of Compliance) Regulations are introduced to ensure the accuracy of the patent expiry date of patents listed in the Patent Register maintained by the Minister of Health. As well, amendments to the Patented Medicines Regulations will ensure accuracy of expiry date information of the patents submitted to the Patented Medicine Prices Review Board.
In conclusion, while the system for Patent Term Adjustment is now becoming a reality, it looks like it will be very difficult for patentees to obtain any additional term for their granted patents. If extending the life of the patent is important, applicants should avoid differing examination and they should respond promptly to Examiner's Reports and to Notices of Allowance, to increase the likelihood of a PTA allowance. The hefty fee to file to request for PTA will also have a chilling effect since this fee alone is greater than the combined total for the filing, examination, and issue fees (currently $2,081 for a standard entity). Do not hesitate to contact us for more information and advice on the proposed PTA and its consequences.
Footnote
1. Canada Gazette, Part I, Volume 158, Number 20: Regulations Amending the Patent Rules and Certain Regulations Made Under the Patent Act, May 18, 2024 (https://canadagazette.gc.ca/rp-pr/p1/2024/2024-05-18/html/reg1-eng.html)
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.