Canada Gazette, Part I, Volume 158, Number 20: Regulations Amending the Patent Rules and Certain Regulations Made Under the Patent Act

May 18, 2024

Statutory authority
Patent Act

Sponsoring department
Department of Industry

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Under the Canada–United States–Mexico Agreement (CUSMA), Parties agreed to provide a means to adjust the term of a patent when there are unreasonable delays in its issuance by the granting authority. Amendments to the Patent Act to provide a framework for an additional term received royal assent in June 2023. These amendments come into force on January 1, 2025. Corresponding amendments to the Patent Rules will set out how various aspects of the additional term framework will operate and be administered, and consequential amendments to the Patented Medicines (Notice of Compliance) Regulations the Certificate of Supplementary Protection Regulations, and the Patented Medicines Regulations will account for the possibility of an additional term. Other minor and housekeeping amendments to the Patent Rules are also sought to facilitate optimal functioning of the patent system.

Background

Canada–United States–Mexico Agreement

CUSMA entered into force on July 1, 2020. Parties to CUSMA agreed to an updated, comprehensive chapter on intellectual property (IP). In addition to committing to making best efforts to process patent applications in an efficient and timely manner, Parties also agreed to provide an additional term to compensate patent owners for unreasonable delays in the issuance of their patents. As per the terms of the agreement, an additional term is available only for applications filed on or after December 1, 2020, and Canada has until January 1, 2025, to implement the obligation.

Amendments to the Patent Act

As a first step towards implementation, amendments were made to the Patent Act to include a framework for granting an additional term. The framework establishes the parameters of an additional term and introduced regulation-making authorities, so that patent owners, the public and the Canadian Intellectual Property Office (CIPO) will know which patents are eligible for an additional term, how the term can be applied for, and how it will be determined. The framework introduced fee requirements for applying for an additional term, for requesting reconsideration of a determination for an additional term, and for maintaining a patent during an additional term. The framework also specifies the rights that are applicable during any additional term. Lastly, it provides a mechanism for the reconsideration of additional term determinations by the Commissioner of Patents at CIPO, and for bringing an action in the Federal Court against a patentee for an order to shorten the duration of an additional term. The Act was also amended to clarify that the term of a certificate of supplementary protection (CSP) runs concurrently with any additional term for the patent. Specifically, the Act prescribes that the term of a CSP takes effect on the expiry of the term under section 44, regardless of whether any additional patent term is granted.

The amended Patent Act requires, subject to conditions, that the Commissioner grant an additional term for a patent if the patent was issued later than five years from a date to be defined in the Patent Rules for divisional applications and national phase entry applications, and the filing date of the application in any other case, and three years from the date of the request for examination (whichever is later). The amended Patent Act requires that, in determining the duration of an additional term, the Commissioner subtract a number of days that is determined under the proposed Patent Rules. The additional term under section 46.1 of the Patent Act begins on the expiry of the term referred to in section 44 of the Patent Act, without taking into account section 46 of the Patent Act, but only if the patent remains valid until, and is not void before, the expiry of that term. In such instances, the patent expires at the expiry of the additional term.

As a next step towards implementation, corresponding regulatory changes are proposed to support the additional term framework in the Patent Act.

Proposed amendments to the Patent Rules for an additional term

The proposed amendments to the Patent Rules would support the amended Patent Act by providing details about the additional term framework. The following key elements will be included.

Additional term determination process

The determination process outlines the steps the Commissioner must follow, from receiving an application for an additional term to making a determination of the duration of the additional term. The process involves an initial assessment of eligibility for an additional term, a preliminary determination of the duration of any additional term, a two-month observation period for receiving submissions from the patentee and interested third parties, and a determination of the duration of the additional term. If an additional term is granted, the Commissioner will issue a certificate of additional term setting out the duration of the additional term along with other prescribed information.

Number of days to be subtracted

The number of days to be subtracted in the determination of an additional term is expressed in the proposed Patent Rules as the sum of days referred to in one or more periods. The periods are defined as beginning on a specified date and ending on a specified date. In the case of overlapping periods, each calendar day is only subtracted once.

Additional term reconsideration process

The additional term reconsideration process allows anyone to challenge the duration of the additional term granted by the Commissioner. The reconsideration process involves filing an application for reconsideration of the additional term and paying the prescribed fee. The application for reconsideration must meet certain formality requirements supporting the application. The Commissioner may dismiss the application for reconsideration or make a preliminary determination as to whether the duration of the additional term is longer than is authorized under the Patent Act. If the preliminary determination is that the duration is longer than authorized, the Commissioner must also provide a preliminary determination of the shortened duration of the additional term. Similar to in the determination process, a two-month observation period follows the preliminary determination. After the end of the period to provide observations, the Commissioner must send a notice to the patentee with the Commissioner’s determination and issue an amended certificate of additional term with the revised duration of the additional term, if applicable.

Fee amounts

The proposed amendments to the Patent Rules include the amounts for a fee to apply for an additional term, for a fee to apply for reconsideration of an additional term, and for maintenance fees to maintain applications and patents in good standing during the additional term.

Consequential amendments to other regulations

This regulatory proposal contains proposed amendments to regulations other than the Patent Rules. Consequential amendments to the Patented Medicines (Notice of Compliance) Regulations, the Certificate of Supplementary Protection Regulations, and the Patented Medicines Regulations are proposed to account for the possibility of an additional term.

Other proposed amendments to the Patent Rules

In an effort to improve the regulatory framework and administration of the patent system, various housekeeping amendments to the Patent Rules are also proposed.

The Canadian Intellectual Property Office

CIPO is a special operating agency of Innovation, Science and Economic Development Canada (ISED) and is responsible for the administration and processing of the greater part of IP in Canada. CIPO’s mission extends beyond delivering services directly to those seeking IP rights and includes the following:

Patents are one of the forms of IP administered by CIPO. A patent is a legal document granted by the Commissioner that gives a patentee exclusive rights to make, use and sell an invention for a limited period of time. In Canada, a patent currently receives a term of 20 years from the application filing date, regardless of when the patent is granted.

In Canada, the substantive examination of a patent application by a patent examiner only occurs when an applicant makes a request for examination. The patent applicant must request examination of the application within four years from the filing date of the patent application.

The patent examiner’s function is to assess whether the patent application conforms with the requirements of the Patent Act and the Patent Rules. This function includes verifying formality requirements and substantive requirements, such as if the invention is new, is not obvious, and is useful. The patent examiner uses their expertise to compare the claimed invention with existing technology as of the filing date, and ensures that the claims in the application are clear and supported by the description, and that the invention can be replicated by someone skilled in the art.

Throughout the examination process, the patent examiner communicates with the patent applicant through written reports, highlighting any deficiencies in the patent application. The patent applicant can then respond by making amendments to overcome the deficiencies or by providing arguments stating why the application is not deficient. This process is iterative and continues until the patent application is approved for allowance or abandoned, or an impasse is reached.

Objective

The central aim of the proposed amendments to the Patent Rules is to support the amended Patent Act by setting out how various aspects of the additional term framework will operate and be administered.

Consequential amendments to the Patented Medicines (Notice of Compliance) Regulations, the Certificate of Supplementary Protection Regulations, and the Patented Medicines Regulations are being proposed to account for the possibility of an additional term.

Various housekeeping amendments are also proposed to improve the functioning of the patent system and to clarify some existing provisions in the Patent Rules.

Description

The proposed regulatory amendments can be grouped as follows: (1) regulatory amendments to complete the additional term framework, (2) amendments to other regulations to account for the possibility of an additional term, (3) miscellaneous amendments to the Patent Rules to improve the regulatory framework.

Amendments to the Patent Rules to support the legislative framework for an additional term

These amendments support the amended Patent Act to provide details on aspects of the additional term framework, such as the number of days to be subtracted in the determination of the duration of an additional term and processes for making a determination of the duration of an additional term and for reconsideration of an additional term. Fee amounts for applying for an additional term, applying for reconsideration of an additional term, and for maintaining the patent during the additional term are further proposed.

The determination of the duration of the additional term will be made by the Commissioner of Patents after receiving an application for an additional term and payment of the prescribed fee. The proposed amendments to the Patent Rules only permit for one application for an additional term per patent. The Commissioner may dismiss the application for an additional term if the application does not meet eligibility requirements in the Patent Act. One requirement is that the patent must be based on a patent application that was filed on or after December 1, 2020. Another requirement is, for a regularly filed patent application, the patent must have been issued after the later of the fifth anniversary of the filing date of the application and the third anniversary of the day the applicant requests examination. For Patent Cooperation Treaty national phase applications and for divisional applications, the same requirement applies but instead of considering the fifth anniversary of the filing date, the Patent Rules establish it is the fifth anniversary of the national phase entry date and the fifth anniversary of the presentation date of the divisional application, respectively, that are relevant.

Following receipt of an application that is not dismissed, the Commissioner must send to the patentee a notice indicating the Commissioner’s preliminary determination of the duration of the additional term. A two-month observation period would follow, after which the Commissioner must provide reasons to the patentee indicating the Commissioner’s decision regarding the determination of the duration of the additional term.

Also proposed is the number of days that is to be subtracted in making a determination. This is expressed by the sum of days in one or more of several periods elucidated in the Patent Rules. The proposed number of days to be subtracted includes days in periods that do not occur during the processing of, or the examination of, the patent application by CIPO, periods that are not directly attributable to CIPO as well as periods that are attributable to the patent applicant. Examples of proposed days in the number of days to be subtracted include days when the patent applicant must take an action or pay a fee and the number of days in periods initiated by the patent applicant, such as requesting continued examination after certain events occur during patent examination. If a day appears in more than one period, each calendar day in those periods is proposed to be subtracted only once.

The fees related to applying for an additional term, applying for reconsideration of the additional term and for maintaining applications and patents in effect from the 20th anniversary of the filing date of the patent application are proposed in the Patent Rules. The fees for an application for an additional term and for an application for reconsideration of an additional term are proposed to be $2,500 as the standard fee and $1,000 for small entities. The maintenance fees for applications and patents, for the 20th and subsequent anniversaries of the filing date of the patent application, are proposed to be $1,000 as the standard fee and $400 for small entities. The maintenance fee regime includes a late fee and an additional fee that become due when a maintenance fee is not paid on or before the anniversary date. The proposed late fee is $150 and the proposed additional fee is $289.19.

Consequential amendments to other regulations

Consequential amendments to the Patented Medicines (Notice of Compliance) Regulations, the Certificate of Supplementary Protection Regulations, and the Patented Medicines Regulations are proposed to account for the possibility of an additional term.

Specifically, in instances where an additional term is granted, the patent expires at the expiry of the additional term. Therefore, proposed amendments to the Patented Medicines (Notice of Compliance) Regulations are meant to ensure the accuracy of the patent expiry date contained in a patent list submitted to the Minister of Health. No further impact on the operation of the regime is intended.

The proposed amendment to the Patented Medicines Regulations is meant to clarify that the obligation on rights holders, under subsection 3(4) of the Patented Medicines Regulations, to ensure accuracy of the patent expiry date information submitted to the Patented Medicine Prices Review Board pursuant to subsection 3(1) of the Patented Medicines Regulations. No further impact on the operation of the regime is intended.

Consistent with the above-mentioned changes to the Patent Act regarding CSPs, proposed amendments to the Certificate of Supplementary Protection Regulations are meant to clarify that an application for a certificate of supplementary protection must contain the date on which the term of the patent under section 44 of the Patent Act will expire. No further impact on the operation of the regime is intended.

Miscellaneous amendments

The proposed amendments to the Patent Rules include a number of miscellaneous amendments designed to improve the regulatory framework. For example:

Regulatory development

Consultation

A public consultation on amendments to the Patent Rules was held from August 7 to September 8, 2023. Interested persons were encouraged to provide their views on the additional term regulatory framework.

Concerns were expressed in relation to the proposed number of days to be subtracted in determinations of an additional term, the Commissioner’s discretionary powers in arriving at the number of days, and third-party involvement in the determination and reconsideration process. There was a divide in opinions on several issues. Some stakeholders opposed the requirements for an application and fee for applying for an additional term as counterproductive to its remedial nature, with suggestions to minimize or eliminate the fee. Others expressed the view that the inclusion of certain proposed days to be factored into the number of days to be subtracted were regarded as punitive, unfair or not aligned with the system in the United States. A range of views were expressed regarding the possibility of Commissioner’s discretion in making a determination of an additional term. Most stakeholders opposed a system with Commissioner’s discretion, favouring a predictable and transparent system that allows patentees to fully assess with certainty their eligibility for an additional term before submitting an application and paying a fee. In contrast, some stakeholders advocated for Commissioner’s discretion as it was seen as vital for addressing deliberate actions on the part of applicants that lead to delays in the issuance of patents.

Generally, stakeholders were content with the process for determining and reconsidering additional terms. However, there were some who expressed resistance to involving third parties in this process, fearing it could become adversarial. Many opposed imposing new notification obligations on CIPO, citing cost and administrative burden.

Lastly, the reaction to miscellaneous and housekeeping amendments aimed at improving the regulatory framework was neutral to slightly positive.

Modern treaty obligations and Indigenous engagement and consultations

The initial assessment examined the geographical scope and subject matter of the initiative in relation to modern treaties in effect and did not identify any potential modern treaty impacts. Therefore, a detailed assessment is not required.

Regulatory analysis

Benefits and costs

Patentees, Canadians, and CIPO will be directly affected by the amendments. The costs and benefits associated with these regulatory amendments are influenced by both the scope of the eventual framework and CIPO’s operational results. The number of patents eligible for an additional term is dependent on the number of days that are to be subtracted and CIPO’s timeliness for processing patent applications. The number of applications for reconsideration will largely be determined by how many patents receive an additional term and how accurate determinations are.

The costs to provide new services will be primarily borne by those benefiting from them. Revenue from fees will help to partially recover the costs.

The impacts of the amendments are forecasted over a 10-year period from fiscal year (FY) 2024–2025 to FY 2033–2034. Unless otherwise stated, all costs and benefits are presented for domestic stakeholders with present values, discounted to 2024 using a 7% discount rate and in 2024 Canadian dollars.

Baseline scenario

Regulatory amendments support the legislative framework for an additional term. If Canada were to not introduce the proposed regulations, the baseline scenario would result in uncertainty for Canadian patentees in determining if the issuance of their patent was unreasonably delayed until such time that Canada brings regulations into force.

Should Canada fail to meet its CUSMA obligations, the United States or Mexico could initiate a dispute using the dispute settlement mechanism available under the CUSMA.

Regulatory scenario

In the regulatory scenario, the proposed amendments come into force on January 1, 2025, and the date the first eligible patents may receive an additional term is December 2, 2025, or after. No maintenance fee revenues for the 20th anniversary or later will be recognized during the forecast period, as the first possible due date for such a maintenance fee would be December 1, 2040. It is estimated that approximately 9% of all additional term applications will be from domestic clients. From FY 2024–25 to FY 2033–34, there are expected to be 1 129 applications for an additional term and 51 applications for reconsideration of an additional term.

Benefits

Benefits to Canadians

The availability of an additional term entails a commitment for Canada to process patent applications in an efficient and timely manner. This supports Canada as a competitive market for investments in innovation.

Having a patent system that compensates for unreasonable delays in the granting process may be a factor in decisions to make new investments in Canada, resulting in incremental economic activity and/or access to new innovations for Canadians.

Benefits to Government

There would be an increase in revenues for CIPO as a result of new fees collected from applications for an additional term and applications for reconsideration. As shown in Table 1, the total incremental revenues from fees paid over a 10-year period are estimated to be $2.08 million. This includes revenues collected from domestic ($0.17 million) and foreign ($1.90 million) fee payers.

Benefits to patentees

Providing an additional term in Canada would offer substantial benefits for patentees who have experienced unreasonable delays in the granting of their patent.

Primarily, the additional term would compensate patentees for unreasonable delays in the granting of a patent by providing an additional term after the expiry of the 20-year patent term under section 44 of the Patent Act.

Secondarily, an additional term framework would put Canada on a level playing field with other major patent jurisdictions such as the United States and Japan, which have already implemented similar mechanisms to compensate patentees for unreasonable delays in the granting of a patent. This would benefit patentees operating internationally.

Costs

Costs to Canadians

An additional term allows the patentee to exclude others from making, using and selling the invention, and could result in higher prices to Canadians for access to the inventions. This is because, in the absence of an additional term, after the expiry of a patent, competitors may enter the market when any person may freely make, use or sell the invention, often resulting in reduced costs to consumers. Further, additional terms delay patented inventions from entering the public domain. These delays may reduce economic activity and/or limit access to new innovations.

Canadians requesting reconsideration of an additional term would face the cost of the application fee as well as the administrative burden in determining if the determination of the additional term was correct.

Table 2 provides the 10-year forecast for all additional term-related fees.

Costs to patentees

Patentees would have to pay the required fee to apply for an additional term. It is also expected that patentees may conduct an initial assessment to determine eligibility for an additional term, which may result in additional administrative burden and costs.

Table 2 provides the 10-year forecast for all fees related to additional terms.

Costs to Government

As shown in Table 2 below, CIPO would incur $3.4 million in implementation costs over the 10-year forecast period. These costs include capital investments in IT infrastructure and operating costs (e.g. additional full-time employees, training).

Table 1: Monetized benefits (FY 2024–25 to FY 2033–34)
Impacted stakeholder Description of benefit 10-year total (present value) Annualized amount
CIPO Additional term fees revenue $2,076,796 $295,689
Table 2: Monetized costs (FY 2024–25 to FY 2033–34)
Impacted stakeholder Description of cost 10-year total (present value) Annualized amount
Canadians & patentees Additional term fees $172,559 $24,568
CIPO Additional term implementation $3,441,392 $489,977
All stakeholders Total $3,613,951 $514,545
Table 3: Net impact (FY 2024–25 to FY 2033–34)
Impacts Total (present value) Annualized Value
Total cost $3,613,951 $514,545
Total benefit $2,076,796 $295,689
Net impact -$1,537,155 -$218,856

The negative net impact of the proposed regulatory amendments is primarily due to the nominal cost recovery rate of 77% and the fact that the majority of the costs (i.e. IT infrastructure investment) related to the amendments occur during the first year of the forecast.

Small business lens

An analysis under the small business lens has determined that the amendments could result in increased costs to the small businesses in Canada that receive patents and that have experienced unreasonable delays in the granting of their patents. However, the introduction of the additional term framework is expected to provide a benefit that does not currently exist for small businesses and individuals that have experienced delays.

Small businesses and individuals make up a relatively small proportion of patentees. The patent system in Canada provides reduced fee levels for small businesses and individuals who make a small entity declaration and who meet the requirements of a “small entity” in the Patent Rules (e.g. an organization with 100 or fewer employees). The proposed regulatory amendments do offer small entity fees for small businesses and individuals that are 40% of the standard fee. Current forecasts indicate that approximately 7.5% of all applications for an additional term will be made by small entities and 2.5% of all applications will come from Canadian small entities. The proposed fees apply to optional services that small businesses and individuals are free to avoid. The total forecasted revenue from small entities for the proposed fees is $21,760. Despite eligibility to pay small entity fees, some small businesses intentionally pay the standard fees. This may be the result of perceived legal risks of paying at the small entity rate.

One-for-one rule

The proposal implements a non-discretionary obligation and is exempt from the requirement to offset administrative burden and regulatory titles under the one-for-one rule.

The proposal will result in an increase in the administrative burden on patent-owning businesses that have experienced unreasonable delays in the granting of their patent, as patent owners must apply for an additional term. The proposed Patent Rules do not require applicants for an additional term to provide a calculation of estimated additional term entitlement; however, given the proposed application fee for an additional term, it is expected that most stakeholders will undertake a preliminary analysis of the additional term eligibility prior to submitting an application. This analysis would result in administrative burden and potential costs for patent owners.

Regulatory cooperation and alignment

The United States has negotiated a similar obligation, to provide an additional term to compensate for unreasonable delays in the granting of a patent, with close to a dozen foreign countries, and the implementation in those countries varies widely. The regimes adopted by CUSMA partners, the United States and Mexico, are described briefly below.

United States

The United States Patent and Trademark Office (USPTO) introduced patent term adjustments in 1999. Its system recognizes 3 different types of delay: “A,” “B” and “C.” A delay of type “A” is linked to service standards (e.g. if the USPTO takes longer than 14 months to issue a first examiner’s report or longer than 4 months to issue subsequent reports). A delay of type “B” occurs if the period between the filing date and the issue date exceeds 3 years; however, a delay of type “B” excludes time consumed by requests for continued examination and appeals or interferences. A delay of type “C” includes various periods, such as time for appeals. These delays of type “A,” “B” and “C” are added up, and any overlapping days are removed. The United States has not capped the duration that can be awarded for an additional term, and provides for a 1:1 ratio of days of compensation to days of delay.

The United States’ approach results in a large percentage of patents receiving an additional term and for significant periods of time.

Mexico

Mexico has capped the duration that can be awarded for an additional term at a maximum of five years, and is offering one day of additional term compensation for every two days of unreasonable delay. The examination phase for a Mexican patent has a maximum of four examination reports and a five-year time limit, after which the patent must either be granted or refused.

In addition to the signatory CUSMA countries, several other jurisdictions have implemented an additional term framework, such as South Korea and Japan.

South Korea

South Korea introduced an additional term framework into their patent system in 2019. In South Korea, a patentee must request an additional term within three months from the issuance of the patent and pay a fee. The patentee does not need to pay any additional fees to maintain the patent in force during the additional term. The maximum additional term that can be granted in South Korea is five years.

The additional term calculation takes into consideration various factors, such as the time taken for examination, the time taken for appeal, and any excluded periods, such as delays caused by the applicant, third parties, or due to circumstances beyond the control of the Korean Intellectual Property Office.

Japan

In 2018 Japan amended its patent act to implement commitments made by signatories in the Trans-Pacific Partnership, an agreement that was later renegotiated as the Comprehensive and Progressive Agreement for Trans-Pacific Partnership. In Japan, a patent may only be considered for an additional term for patent office delays if the patent is issued more than five years after filing or three years after a request for examination, whichever is later.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus

ISED conducted a preliminary gender-based analysis plus to determine if any groups or individuals, including the general public, patent applicants, patentees and IP agents, will be affected differently than others based on factors such as gender, sex, age, language, education, geography, culture, ethnicity, income, and ability.

The results are not conclusive given the limited data available; however, members of different demographic groups may be impacted differently based on the pre-existing patent landscape in Canada. Overall, it is anticipated that the proposal will positively impact patentees and their employees and negatively impact those who do not participate in the patent system. Therefore, amendments to the Patent Rules to implement the framework for an additional term will likely positively impact those of higher incomes and educational backgrounds and remain a barrier to demographic groups that do not hold educational backgrounds in science and technology.

Implementation, compliance and enforcement, and service standards

Implementation

The proposed amendments would come into force on January 1, 2025.

It is anticipated that affected stakeholders would have sufficient time between publication in the Canada Gazette, Part II, and the coming-into-force date to familiarize themselves with the regulatory changes and to implement any changes needed to their processes. Notably, it is not until 11 months after the coming-into-force date that patents could be eligible for an additional term, which represents additional time to prepare for the changes.

As part of the implementation of the amendments, CIPO would notify stakeholders of the coming-into-force date of the amendments. Outreach would be conducted proactively and through different means, including direct emails and social media posts.

Service standards

In accordance with the Service Fees Act, CIPO has proposed service standards for the proposed fees. The service standards are as follows:

These standards consider forecasted volumes, current resources, and operational feasibility. To ensure client-centric service delivery, CIPO adheres to the Policy on Service and Digital, maintaining transparency and continuous improvement. In the event of unmet standards, remissions are considered, based on the proportion of non-compliance, external circumstances, and the requesting party’s role.

CIPO’s remission policy provides remissions for missed service standards. Remissions range from 25% to 50% of the fee paid, determined by the extent of service standard non-compliance.

Contact

Virginie Ethier
Assistant Commissioner and Director General
Patent Branch
Canadian Intellectual Property Office
Innovation, Science and Economic Development Canada
Telephone: 819‑997‑2949
Email: cipoconsultations-opicconsultations@ised-isde.gc.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council proposes to make the annexed Regulations Amending the Patent Rules and Certain Regulations Made Under the Patent Act under subsections 12(1)footnote a, 55.2(4)footnote b, 101(1)footnote c and 134(1)footnote d of the Patent Act footnote e.

Interested persons may make representations concerning the proposed Regulations within 45 days after the date of publication of this notice. They are strongly encouraged to use the online commenting feature that is available on the Canada Gazette website but if they use email, mail or any other means, the representations should cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to Virginie Ethier, Assistant Commissioner and Director General, Patent Branch, Canadian Intellectual Property Office, Department of Industry (email: cipoconsultations-opicconsultations@ised-isde.gc.ca, tel.: 819‑997‑2949).

Ottawa, May 10, 2024

Wendy Nixon
Assistant Clerk of the Privy Council

Regulations Amending the Patent Rules and Certain Regulations Made Under the Patent Act

Patent Rules

1 (1) Section 3 of the Patent Rulesfootnote 1 is amended by adding the following after subsection (3):

Extension — request for examination

(3.1) The Commissioner is authorized to extend the period of time for the payment of a fee referred to in subsection 80(1) after the expiry of that period if the Commissioner considers that the circumstances justify the extension and if

(2) Section 3 of the Rules is amended by adding the following after subsection (4):

Extension — date of payment

(5) If the Commissioner extends the period of time for the payment of a fee under subsections (3) to (4), that fee is deemed to have been paid on the day on which the small entity fee was paid or the insufficient payment was made, as the case may be.

Non-application of subsection 128(1)

(6) Subsection (5) does not apply to the determination of the date of the payment of a fee under subsection 128(1).

2 (1) The portion of section 5.2 of the Rules before paragraph (a) is replaced by the following:

Extension of time for payment of fee

5.2 For greater certainty, if the Commissioner extends the period of time for the payment of a fee under subsection 3(3), (3.1) or (4), the applicable fee is

(2) Paragraph 5.2(b) of the Regulations is replaced by the following:

3 Subsection 7(2) of the Rules is replaced by the following:

Electronic communications

(2) If a person who is doing business before the Patent Office authorizes the sending of communications by electronic means specified by the Commissioner, a written communication sent by the Commissioner or the Patent Office to that person by those means is, unless the communication is withdrawn, considered to have been sent to that person on the date borne by the communication.

4 Section 10 of the Rules is amended by adding the following after subsection (4):

Date of receipt — service provider

(5) Despite subsection (4), documents, information or fees referred to in that subsection that are first transmitted to a service provider specified by the Commissioner as authorized to receive them and then are either transmitted or made available to the Commissioner or the Patent Office, are deemed to have been received by the Commissioner or the Patent Office on the day on which, according to the local time of the place where the Patent Office is located, the service provider receives them.

5 The portion of subsection 37(2) of the Rules before paragraph (a) is replaced by the following:

Exceptions

(2) In any business before the Patent Office for the purposes of making observations under subsection 117.11(7), granting an additional term under section 46.1 of the Act, reissuing a patent under section 47 of the Act, making a disclaimer under section 48 of the Act, filing a reply under subsection 48.2(5) of the Act or participating in a re-examination proceeding under section 48.3 of the Act,

6 Section 40 of the Rules is amended by adding the following after subsection (1):

Communication of notice

(1.1) The notice under subsection (1) must also be sent to the common representative of the joint applicants or joint patentees.

7 Subsection 41(1) of the Rules is replaced by the following:

Notice of disregarded communication

41 (1) If a patent agent who is not appointed to represent an applicant or patentee in respect of a patent or an application for a patent communicates in writing with the Commissioner on behalf of that applicant or patentee for the purpose of prosecuting or maintaining in effect that application or for the purpose of a procedure relating to that patent and the communication identifies that patent agent, the Commissioner must by notice inform the patent agent and the applicant or patentee that the Commissioner will not have regard to that communication unless, not later than three months after the date of the notice, the patent agent is appointed to represent that applicant or patentee in respect of that application or patent and requests that the Commissioner have regard to the communication.

8 Subsection 41.1(2) of the Rules is replaced by the following:

Notice

(2) If the patent agent is not named, the Commissioner must by notice inform the sender and the applicant or patentee that the Commissioner will not have regard to the written communication unless, not later than three months after the date of the notice, the patent agent who submitted the communication provides their name to the Commissioner and requests that the Commissioner have regard to the communication.

9 Paragraph 73(1)(b) of the Rules is replaced by the following:

10 Subsection 84(2) of the Rules is amended by striking out “or” at the end of paragraph (a), by adding “or” at the end of paragraph (b) and by adding the following after paragraph (b):

11 (1) The portion of subsection 86(15) of the Rules before paragraph (a) is replaced by the following:

Withdrawal of conditional notice of allowance after reply

(15) If an applicant replies in good faith to a conditional notice of allowance on or before the date set out in subsection (16) but the examiner, after receiving the reply, has reasonable grounds to believe that the application for a patent still does not comply with the Act or these Rules in respect of any of the defects referred to in that notice or that the amendments in reply to that notice are not made in accordance with subsection 100(1), the Commissioner must

(2) Subsection 86(17) of the Rules is replaced by the following:

Suspension of examination

(17) The examination of an application for a patent under subsection 35(1) of the Act is suspended during the following periods:

Validity of notice

(17.1) The suspension of an examination under subsection (17) has no effect on the validity of a notice sent to the applicant during the period of suspension.

12 Section 87 of the Rules is amended by adding the following after subsection (1.1):

Claims deemed not included

(1.2) For the purposes of subparagraphs (1)(a)(iii) and (b)(iii), the claims contained in an amendment under section 38.2 of the Act are deemed not to be included in the patent application if

13 The Rules are amended by adding the following after section 117:

Additional Term

Application

Submitting an application

117.01 (1) For the purposes of paragraph 46.1(1)(c) of the Act, the application for an additional term must be submitted in writing and must indicate the patent number related to the application.

Correction — patent number

(2) An error in the patent number referred to in an application for an additional term may be corrected by the patentee within three months after the day on which the patent is issued.

Prescribed fee

(3) The prescribed fee for an application for an additional term is the small entity fee set out in paragraph 41(a) of Schedule 2 if the small entity status condition set out in subsection 112(2) is met and a small entity declaration is filed in accordance with subsection 112(3) in respect of the patent or filed in accordance with subsection 44(3) in respect of the application on the basis of which the patent is granted, or in any other case, the standard fee set out in paragraph 41(b) of Schedule 2.

One application

(4) Only one application for an additional term may be submitted for a given patent.

Dismissal of application

(5) If an application does not meet the requirements set out in paragraphs 46.1(1)(a) to (c) of the Act, the Commissioner may dismiss the application and, if dismissed, the application is deemed never to have been made and the Commissioner must send a notice to the patentee to that effect.

Notice of preliminary determination

(6) Following receipt of an application, the Commissioner must send a notice to the patentee indicating the Commissioner’s preliminary determination of the duration of the additional term.

Observations

(7) The patentee and any other person may make observations regarding the preliminary determination within two months of the date of the notice.

Certificate or dismissal

(8) After the end of the period to make observations, the Commissioner must either issue a certificate of additional term in accordance with subsection 46.1(7) of the Act or dismiss the application. The Commissioner must provide reasons for the determination of the duration of the additional term included in the certificate or for dismissing the application, as the case may be.

Prescribed day — paragraph 46.1(2)(a) of the Act

117.02 (1) For the purposes of paragraph 46.1(2)(a) of the Act, the prescribed day is the presentation date.

Prescribed day — paragraph 46.1(2)(b) of the Act

(2) For the purposes of paragraph 46.1(2)(b) of the Act, the prescribed day is the national phase entry date.

Days to be subtracted

117.03 (1) Subject to subsections (5) to (11), the number of days to be subtracted under subsection 46.1(4) of the Act is the sum of all the days referred to in one or more of the following periods:

More than one period

(2) Paragraphs (1)(a) to (c), (e) to (j), (l), (m), (p) to (t) and (v) to (z.12) may include more than one period.

Power to designate day

(3) For the purposes of subsection 46.1(4) of the Act, the Commissioner may designate a day to be subtracted if operations at the Patent Office are significantly disrupted for all or part of the day during ordinary business hours due to circumstances beyond the control of the Patent Office.

List of designated days

(4) The Commissioner must publish a list of the days referred to in subsection (3) on the website of the Canadian Intellectual Property Office.

Days included in period

(5) The number of days in any period referred to in subsection (1) includes the first day but does not include the last day.

Day included in more than one period

(6) If a day is included in more than one period referred to in subsection (1), that day is included only once in the sum referred to in that subsection.

Days not included

(7) The periods referred to in subsection (1) are deemed not to include any day prior to the applicable day under subsection 46.1(2) of the Act or any day after the day on which the patent is issued.

Previous days not included

(8) If the day that is five years after the applicable day under subsection 46.1(2) of the Act falls on a day before the day that is three years from the day that, in respect of the application for the patent, a request for examination has been made under section 35 of the Act in respect of the application for the patent, the prescribed fee referred to in subsection 35(1) of the Act has been paid and, if applicable, the prescribed late fee referred to in paragraph 35(3)(a) of the Act has been paid, without taking subsection 35(4) of the Act into account, the periods referred to in subsection (1) are deemed not to include the days preceding the applicable day.

Withdrawn communication

(9) If a communication sent by the Commissioner or the Patent Office is withdrawn, that communication is not considered to have been sent for the purposes of subsection (1), except for a communication sent in a period referred to in paragraph (1)(z.05), (z.06), (z.07), (z.08) or (z.1).

Number equal to zero

(10) If the date on which a period prescribed in subsection (1) has an end date that occurs on or before the start date, the number of days in that period is zero.

End of period

(11) If a period that began under subsection (1) does not end on or before the date of the issuance of the patent, then the period ends on that date.

Information on the certificate

117.04 (1) The certificate that is issued under subsections 46.1(7), 46.3(5) or 46.4(3) of the Act must also indicate the filing date of the patent application on the basis of which the patent was granted, the title of the invention and the date the certificate is issued.

Correction of certificate

(2) The Commissioner is authorized to correct any typographical error in a certificate issued under subsection 46.1(7), 46.3(5) or 46.4(3) of the Act.

Availability of certificate

(3) The Commissioner must make available on the website of the Canadian Intellectual Property Office a copy of any certificate of additional term or any amended certificate of additional term issued by the Commissioner.

Maintaining Rights Accorded by a Patent

Prescribed fee

117.05 (1) Subject to subsection (3), for the purposes of subsection 46.2(1) of the Act, the prescribed fee to maintain the rights accorded by a patent in effect is, for an anniversary date set out in item 42 of Schedule 2 that falls on or after the day on which the patent was issued,

Non-application of subsection 3(1)

(2) Subsection 3(1) does not apply in respect of the times referred to in subsection (1).

Exception

(3) For the purposes of subsection 46.2(1) of the Act, if a patent is granted on the basis of an application for a patent after the 19th anniversary of the filing date of the application, in respect of which a fee was payable under subsection 27.1(1) of the Act for an anniversary of the filing date of the application that fell within the 12-month period preceding the day on which the patent was issued but that was not yet paid before that day, the prescribed fee to maintain in effect the rights accorded by the patent is, for the date of the first of the anniversaries of the filing date of the application that fall on or after the day on which the patent was issued, the total of

Prescribed dates

117.06 For the purposes of subsection 46.2(1) of the Act, the prescribed dates are

Clarification

117.07 For greater certainty, for the purposes of sections 117.05 and 117.06, a reissued patent is considered to be granted on the basis of the original application and is considered to be issued on the day on which it is reissued.

Late fee

117.08 For the purposes of paragraph 46.2(2)(a) of the Act, the prescribed late fee is the fee set out in item 43 of Schedule 2.

Time — paragraph 46.2(5)(a) of Act

117.09 (1) For the purposes of paragraph 46.2(5)(a) of the Act, the prescribed time is 12 months after the end of the six-month period referred to in subsection 46.2(4) of the Act.

Non-application of subsection 3(1)

(2) Subsection 3(1) does not apply in respect of the time prescribed by subsection (1).

Additional prescribed fee

117.1 For the purpose of subparagraph 46.2(5)(a)(iii) of the Act, the additional prescribed fee is the fee set out in item 44 of Schedule 2.

Reconsideration

Application for reconsideration

117.11 (1) An application for reconsideration under subsection 46.3(2) of the Act must be made in writing and must

Prescribed fee

(2) The prescribed fee for an application is

Clarification

(3) For greater certainty, for the purposes of subparagraph (2)(a)(i), a reissued patent is considered to be granted on the basis of the original application.

Small entity status condition

(4) For the purpose of subparagraph (2)(a)(ii), the small entity status condition is that the person applying for reconsideration is, on the date of the application for reconsideration,

Small entity declaration

(5) For the purpose of subparagraph (2)(a)(ii), a small entity declaration must

Notice of preliminary determination

(6) Following the receipt of an application for reconsideration or the initiation of a reconsideration by the Commissioner, the Commissioner must send to the patentee and, if applicable, the person applying for reconsideration a notice indicating the Commissioner’s preliminary determination of

Observations

(7) The patentee, the person applying for reconsideration, if applicable, or any other person may make observations regarding the preliminary determination within two months of the date of the notice.

Certificate or dismissal

(8) After the end of the period to make observations, the Commissioner must either issue an amended certificate of additional term or dismiss the application. The Commissioner must provide to the patentee and, if applicable, the person applying for reconsideration reasons for the shortened duration of the additional term included in the amended certificate or for dismissing the application, as the case may be.

14 (1) Subparagraphs 128(d)(i) and (ii) of the English version of the Rules are replaced by the following:

(2) Section 128 of the Rules is amended by striking out “and” at the end of paragraph (c) and by adding the following after paragraph (d):

(3) Section 128 of the Rules is renumbered as subsection 128(1) and is amended by adding the following after subsection (1):

Fee considered paid — small entity

(2) For the purposes of subsection (1), a fee is considered to have been paid on the day on which a small entity fee was paid if on or before the date of that payment a small entity declaration is filed in accordance with subsection 112(3) in respect of the patent or in accordance with subsection 44(3) in respect of the application on the basis of which the patent is granted.

Fee considered paid — insufficient payment

(3) For the purposes of subsection (1), a fee is considered to have been paid on the day on which an insufficient payment was made if

15 Subsection 139(1) of the Rules is amended by adding the following after paragraph (g):

16 Section 232 of the Rules is replaced by the following:

Periods referred to in section 128

232 (1) For greater certainty, the periods prescribed by paragraph 128(1)(a), (b) or (d) do not include any period that begins less than six months after October 30, 2019.

Periods prescribed by section 128

(2) If a period under paragraph 128(1)(a) or (b) or paragraph 128(d), as it read immediately before the day on which this subsection comes into force, had started but had not ended on or before that day, the period is deemed to have ended on that date if, on or before that date,

17 The Rules are amended by adding the following after section 235:

Filing date before December 1, 2020

236 The fees set out in paragraph (e) of item 8 of Schedule 2 do not apply in respect of an application for a patent for which the filing date is before December 1, 2020.

Non-application of paragraph 84(2)(c)

237 Paragraph 84(2)(c) does not apply in respect of a request for continued examination made before the coming into force of this section.

Non-application of subsection 87(1.2)

238 Subsection 87(1.2) does not apply in respect of an amendment made before the coming into force of this section.

18 Schedule 2 to the Rules is amended by replacing the references after the heading “SCHEDULE 2” with the following:

19 Item 8 of Schedule 2 to the Rules is amended by adding the following after paragraph (d):
Item

Column 1

Description

Column 2

Amount ($)
8 (e) for the dates of each of the 20th and all subsequent anniversaries of the filing date of the application,
(i) small entity fee 400.00
(ii) standard fee 1,000.00

20 Schedule 2 to the Rules is amended by adding the following after Part 7:

Fees in Respect of an Additional Term

PART 8
Item

Column 1

Description

Column 2

Amount ($)
41 Fee for an application for an additional term or for an application for reconsideration
(a) small entity fee 1,000.00
(b) standard fee 2,500.00
42 Fee for maintaining in effect the rights accorded by a patent during an additional term under subsection 46.2(1) of the Act
(a) small entity fee for the dates of each of the 20th and all subsequent anniversaries of the filing date of the application on the basis of which the patent was granted 400.00
(b) standard fee for the dates of each of the 20th and all subsequent anniversaries of the filing date of the application on the basis of which the patent was granted 1,000.00
43 Late fee under subsection 46.2(2) of the Act 150.00
44 Additional fee under subparagraph 46.2(5)(a)(iii) of the Act 289.19

Patented Medicines (Notice of Compliance) Regulations

21 Subsection 3(8) of the Patented Medicines (Notice of Compliance) Regulations footnote 2 is replaced by the following:

(8) The Minister may consult with officers or employees of the Patent Office for the purposes of determining whether a patent or certificate of supplementary protection is to be added to or deleted from the register, or for the purpose of verifying the date on which the duration of any additional term of any patent on a patent list submitted to the Minister will expire.

22 (1) Paragraph 4(4)(c) of the Regulations is replaced by the following:

(2) Subsection 4(7) of the Regulations is replaced by the following:

(7) A first person who has submitted a patent list must keep the information on the list up to date, including by informing the Minister of the date on which the duration of any additional term, which is set out in a corresponding certificate of additional term that is made available on the website of the Canadian Intellectual Property Office under subsection 117.04(3) of the Patent Rules or set out in an order made under subsection 46.4(2) of the Patent Act, will expire, but, in so doing, may not add a patent to the list.

Patented Medicines Regulations

23 Subsection 3(4) of the Patented Medicines Regulations footnote 3 is replaced by the following:

(4) The information referred to in subsection (1) shall be up to date and any change to that information shall be reported within 30 days of the change, including by providing the date on which the duration of any additional term of the patent, set out in the corresponding certificate of additional term that is made available on the website of the Canadian Intellectual Property Office, under subsection 117.04(3) of the Patent Rules, or set out in an order made under subsection 46.4(2) of the Act, will expire.

Certificate of Supplementary Protection Regulations

24 Paragraph 6(3)(b) of the Certificate of Supplementary Protection Regulations footnote 4 is replaced by the following:

25 Paragraph 13(a) of the Regulations is replaced by the following:

Coming into Force

26 These Regulations come into force on January 1, 2025, but if they are registered after that day, they come into force on the day on which they are registered.

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