The Canadian Intellectual Property Office (CIPO) has launched a pilot program to provide accelerated examination of Canadian patent applications concerning medical technology related to COVID-19 and for which Health Canada approval has been obtained or is pending.
Eligible applicants
The pilot program is available to a patent applicant who:
1. has filed a patent application for an invention supporting the health-related response to COVID-19; and
2. qualifies as a small entity – in general terms a small entity is an individual, a university, or an entity employing no more than 50 employees, but professional advice should be sought on this point.
Eligible patent applications
CIPO will accelerate examination of patent applications for COVID-19 related products where the claimed invention is currently or has been subject to a Health Canada approval process including but not limited to:
- a Medical Device Licence (MDL);
- a Medical Device Establishment Licence (MDEL);
- an authorization under the Interim Order respecting the importation and sale of medical devices for use in relation to COVID-19;
- an investigational testing authorization (ITA);
- an authorization under the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19;
- No Object Letter (NOL) for clinical trials;
- Notice of Compliance (NOC); and,
- an authorization under Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
Request requirements
To request accelerated examination the applicant must submit a letter to CIPO that includes:
- a statement that the technology is medical and related to COVID-19 and that an approval for its use has been submitted to or has been obtained from Health Canada;
- a small entity declaration if one has not already been submitted;
- a request that the application be laid open to public inspection if the application is not already open to public inspection (applications are laid open no later than 18 months from the earliest priority date, or 18 months from the filing date if there is no priority claim); and
- a request for examination and payment of the examination fee if not already done.
Accelerated examination
Upon approval of a request for accelerated examination, the applicant may expect to receive a communication from CIPO (likely either an Examiner’s Report or Notice of Allowance) within three months.
Loss of accelerated examination status
The application will be returned to its routine order of examination if the applicant requests an extension of time or misses any deadline.
Term and limits of pilot program
Access to the pilot program is limited to 50 patent applications and the program can be terminated by CIPO at any time.
Comparison to existing accelerated examination procedures
Pursuant to section 84 of the Patent Rules, the Commissioner of Patents must advance out of its routine order the examination of a patent application on the request of any person who pays a CAD $500 fee and files a statement indicating that failure to advance the examination of the application is likely to prejudice that person’s rights.
The procedure under section 84 is available to both small entities and “standard” entities, and is not limited to any particular type of technology or regulatory approval process. Accordingly, the main benefit of the pilot program is that if a small entity has made an invention related to combating COVID-19 and the invention is subject to a Health Canada approval process, they can accelerate examination of the application without payment of the usual CAD $500 government fee.
Under section 84 of the Patent Rules, the Commissioner of Patents must not advance the examination of the application for a patent out of its routine order or, if the examination is advanced, must return it to its routine order if
(a) the Commissioner has granted an extension of time for doing anything in respect of the application; or
(b) the application is or was deemed to be abandoned (applications are generally subject to reinstatement within 12 months of abandonment).
Although the limitations on access to accelerated examination are phrased in a somewhat less precise manner in the pilot program, perhaps they will be applied in largely the same manner. One clear distinction may be that, under the pilot program, missing a deadline or obtaining an extension of time prior to requesting accelerated examination is not a bar to accelerated examination as would be the case under section 84 of the Patent Rules.
For further assistance or information about accelerated examination of a Canadian patent application, please reach out to a member of our Patents and Life Sciences Regulatory & Compliance practice group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.