Regulations Amending the Patent Rules and Certain Regulations Made Under the Patent Act: SOR/2024-241

Canada Gazette, Part II, Volume 158, Number 26

Registration
SOR/2024-241 November 29, 2024

PATENT ACT

P.C. 2024-1267 November 29, 2024

Her Excellency the Governor General in Council, on the recommendation of the Minister of Industry and the Minister of Health, makes 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, 124(2)footnote d and 134(1)footnote e of the Patent Act footnote f.

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

Patent Rules

1 (1) Section 3 of the Patent Rules footnote 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 end of that period if the Commissioner considers that the circumstances justify the extension and

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

Extension — date of payment

(5) If under any of subsections (3) to (4), the Commissioner extends the period of time for the payment of a fee, 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 to subsection 128(1)

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

2 The Rules are amended by adding the following before section 5.1:

Fee deemed paid

5.01 If these Rules set out a small entity fee and a standard fee in respect of a patent or an application for a patent, a standard fee is deemed to be paid on the day on which a small entity fee is paid if

Amount due — day of last partial payment

5.02 (1) Subject to section 5.2, if a fee is paid by means of two or more partial payments, the amount of the fee to be paid is the amount that would be payable if the full amount of the fee had been paid on the day on which the last partial payment is received.

Amount due — day requirements met

(2) Subject to subsection (3), the amount of the fee to be paid for an examination of an application for a patent under subsection 35(1) of the Act is the amount of the fee that is payable on the day on which the request for examination is made and the fee is paid or, if the request is made and the fee is paid on different days, the later of those days.

Amount due — day of amendment

(3) The amount of the fee to be paid for an examination of an application for a patent under subsection 35(1) of the Act is, if the applicant submits an amendment referred to in section 83.1, the amount of the fee that is payable on the day on which the applicant makes the amendment referred to in section 83.1.

3 (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 Rules is replaced by the following:

4 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.

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

Date of receipt — service provider

(5) Despite subsection (4), if documents, information or fees referred to in that subsection are first transmitted to a service provider authorized by the Commissioner to receive them and then are either transmitted or made available to the Commissioner or the Patent Office, they 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.

6 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,

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

Communication of notice

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

8 Section 41 of the Rules is amended by adding the following after subsection (1):

Communication of notice

(1.1) The notice must also be sent to the applicant or to the patentee.

9 Section 41.1 of the Rules is amended by adding the following after subsection (2):

Communication of notice

(2.1) The notice must also be sent to the applicant or the patentee.

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

11 Section 83.1 of the Rules is replaced by the following:

Date of receipt

83.1 If an amount paid for the examination of an application for a patent is less than the prescribed fee referred to in subsection 80(1) and an amendment is made to the application to reduce the number of claims, on or after the day on which the request for examination is made and on or before the date the fee is considered to have been paid, such that the amount paid is greater than or equal to the amount of that prescribed fee, the amount paid is considered to have been received on the day on which the amendment is made.

12 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):

13 (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 referred to 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.

14 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 to an application for a patent are deemed not to be included in the patent application if

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

Additional Term

Application

Submitting application

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

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 on or before the later of

Prescribed fee

(3) The prescribed fee for an application for an additional term is the standard fee set out in paragraph 41(b) of Schedule 2 or, 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, the small entity fee set out in paragraph 41(a) 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 the Commissioner dismisses an application that does not meet the requirements set out in paragraphs 46.1(1)(a) to (c) of the Act, 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 the application, the Commissioner must send a notice to the patentee indicating the Commissioner’s preliminary determination of the duration of the additional term, unless the application has been dismissed under subsection (5).

Observations

(7) The patentee may make observations regarding the preliminary determination within two months after the date of the notice.

Certificate or dismissal

(8) After the end of the period for making 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 duration of the additional term set out in the certificate or for the dismissal of the application, as the case may be.

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

Applicable periods

117.03 (1) Subject to subsections (5) to (11), the number of days to be subtracted in determining the duration of an additional term under subsection 46.1(4) of the Act is the sum of all the days included in the following periods as applicable:

More than one period

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

Power to designate day

(3) For the purposes of paragraph (1)(z.12), the days that the Commissioner may designate are those during which the 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 before the applicable day referred to in 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 fifth anniversary of the applicable day referred to in subsection 46.1(2) of the Act falls before the third anniversary of the first day, without taking subsection 35(4) of the Act into account, on which 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, the periods referred to in subsection (1) are deemed not to include the days preceding that first 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 determining the periods referred to in subsection (1), except for the purposes of determining those referred to in paragraph (1)(z.05), (z.06) or (z.07).

Number equal to zero

(10) If the day on which a period referred to in subsection (1) ends on or before the day on which the period begins, the number of days in the period is zero.

End of period

(11) If a period that begins under subsection (1) does not end under subsection (1) on or before the day on which the patent is issued, then the period ends on that day.

Non-application of paragraph (1)(z.08)

(12) Paragraph (1)(z.08) does not apply in respect of a notice requiring the applicant to take an action within a specified period if the applicant, on the day on which they notify the Commissioner in writing that they did not receive the notice, files a statement that they are notifying the Commissioner without undue delay after they became aware of the notice and the fact that they had not received it.

Certificate of Additional Term

Information on certificate

117.04 (1) A certificate issued under subsection 46.1(7), 46.3(5) or 46.4(3) of the Act must indicate the filing date of the application on the basis of which the patent was granted, the title of the invention and the day on which 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 amended certificate of additional term issued by the Commissioner.

Maintaining in Effect Rights Accorded by Patent During Additional Term

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 43 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 periods of time 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, and a fee in respect of the application 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 the fee was not paid before that day, the prescribed fee to maintain in effect the rights accorded by the patent is, for the date of the first anniversary of the filing date of the application that falls 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 subsection 46.2(2) of the Act, the prescribed late fee is the fee set out in item 44 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 the period of 12 months that follows 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 45 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) For the purposes of subsection 46.3(2) of the Act, the prescribed fee for an application for reconsideration 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) The small entity status condition is that the person applying for reconsideration is, on the day on which the application for reconsideration is made,

Small entity declaration

(5) A small entity declaration must

Notice of preliminary determination

(6) After the Commissioner initiates a reconsideration or receives an application for reconsideration, 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 and the person applying for reconsideration, if applicable, may make observations regarding the preliminary determination within two months after the date of the notice.

Certificate or dismissal

(8) After the end of the period for making 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 indicated in the amended certificate or for dismissing the application, as the case may be.

16 (1) Subparagraphs 128(d)(i) and (ii) 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 is paid if, on or before that day, 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 was 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

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

(2) Section 139 of the Rules is amended by adding the following after subsection (2):

Services Fee Act

(3) The Commissioner must not refund all or part of a fee referred to in subsection (1) that is remitted or is required to be remitted under the Service Fees Act.

18 Subsections 154(5) and (5.1) of the Rules are repealed.

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

Periods prescribed by subsection 128(1)

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 subsection 128(1)

(2) A period prescribed by paragraph 128(1)(a) or (b) or paragraph 128(1)(d), as it read immediately before the day on which this subsection comes into force, that began before that day but did not end on or before that day is deemed to have ended on that day if, on or before that day,

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

Filing date before December 1, 2020

236 The fees set out in paragraph 8(e) 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 day on which this section comes into force.

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

(Sections 3, 4, 44, 45, 68, 70, 73, 80, 82, 84, 85.1 to 87, 100, 105, 106, 109, 112, 115, 117, 117.01, 117.03, 117.05, 117.08, 117.1, 117.11, 119, 121, 122, 124 to 127, 129, 132, 134, 136 to 139, 140, 147, 148, 149, 150, 151, 154, 171, 199, 203, 208, 212, 213, 229 and 236)

22 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 the 20th and each subsequent anniversary of the filing date of the application,
  • (i) small entity fee
 400.00
  • (ii) standard fee
 1,000.00

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

PART 8

Fees in Respect of an Additional Term
Item

Column 1

Description

Column 2

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

Patented Medicines (Notice of Compliance) Regulations

24 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 verifying the date on which any additional term granted for any patent that is on a patent list submitted to the Minister will expire.

25 (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 any additional term granted for the patent – as 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 Patent Act – will expire, but, in so doing, may not add a patent to the list.

Patented Medicines Regulations

26 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 after the day on which the change is made, including by providing the date on which any additional term granted for the patent – as 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

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

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

Coming into Force

29 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.

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 will 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 desired 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 make 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 providing an additional term. The framework establishes the parameters for an additional term and introduces 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 it can be applied for, and how it will be determined. The framework introduced fee requirements for applying for an additional term, requesting reconsideration of a determination for an additional term, and for maintaining a patent during an additional term. It 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. Therefore, the Act specifies 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 shall 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). In determining the duration of an additional term, the amended Patent Act requires the Commissioner to subtract a number of days that is determined under the 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 introduced to support the additional term framework in the Patent Act.

Amendments to the Patent Rules for an additional term

The amendments to the Patent Rules support the amended Patent Act to provide 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 a determination of the duration of the additional term. The Commissioner will issue a certificate of additional term setting out the duration of the additional term along with other prescribed information if an additional term is granted.

Number of days to be subtracted

The number of days to be subtracted in the determination of an additional term is expressed in the 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 Commissioner may reconsider the duration of an additional term on the Commissioner’s own initiative. Further, any person may apply for reconsideration of an additional term granted by the Commissioner if they believe that the duration of additional term is longer than is authorized. The reconsideration process by a person other than the Commissioner involves filing an application for reconsideration of the additional term and paying the prescribed fee. The application for reconsideration must include 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 the determination process, a two-month period follows the preliminary determination, wherein the patentee and the person who initiated the reconsideration (if applicable) may submit observations. 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 amendments to the Patent Rules include fee amounts for an application for an additional term, an application for reconsideration of additional term, and fees to maintain applications in good standing if still pending at 20 years from the filing date and patents in good standing during the additional term.

Consequential amendments to other regulations

This regulatory proposal contains 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 to account for the possibility of an additional term.

Other 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 introduced.

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 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. Presently, in Canada a patent receives a term of 20 years from the application filing date, regardless of when it 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 prescribed time for requesting examination and for paying the associated fee is four years after the filing date of the patent application.

The patent examiner’s function is to assess if the patent application conforms with the requirements of the Patent Act and the Patent Rules. This includes verifying formality requirements and substantive requirements, such as if the invention is new, non-obvious, and useful. The patent examiner uses their expertise to compare the claimed invention with existing technology as of the filing date and ensures the claims in the application are clear, supported by the description, and 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 and oral interviews, highlighting any defects in the patent application. The patent applicant can then respond by making amendments to overcome the defects or by providing arguments for why the application is not defective. This is an iterative process that continues until the patent application is either approved for allowance, abandoned, or an impasse is reached.

Objective

The central aim of the 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 introduced to account for the possibility of an additional term.

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

Description

The 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 and; 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 applications still pending at 20 years from the filing date and for maintaining patents during the additional term are also introduced.

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 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 without making a determination if the application does not meet certain 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 requirements apply but instead of considering the anniversary of the filing date, the Patent Rules establish it is the anniversary of the national phase entry date or of the presentation date of the divisional application, respectively, that is 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 will follow, after which the Commissioner must dismiss the application for additional term or issue a certificate of additional term, along with reasons.

The Patent Rules include the number of days that is to be subtracted in making a determination. This is expressed by the sum of the days in one or more periods. Examples of days in the number of days to be subtracted include days when the Office is awaiting an action or fee from the patent applicant and days in periods initiated by the patent applicant, such as requesting continued examination. As any unique day may appear in more than one period, the Patent Rules specify that each calendar day may be subtracted only once.

The fee amounts for an application for an additional term, an application for reconsideration of an additional term and for maintaining applications and patents in good standing from the 20th anniversary of the filing date of the patent application are established in the Patent Rules. The fees for an application for an additional term and for an application for reconsideration of an additional term will 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, will be $1,000 as the standard fee and $400 for small entities. The maintenance fee regime includes a late fee that is required if a maintenance fee deadline is missed. For patent applications, a reinstatement fee becomes due if the application is deemed abandoned for non-payment of the maintenance fee and the late fee. For patents, an additional fee becomes due if the patent’s term is deemed expired for non-payment of the maintenance fee and the late fee. The late fee is $150 and the additional fee is $289.19. The reinstatement fee for patent applications is unchanged.

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 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, 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 amendment to the Patented Medicines Regulations is meant to clarify 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 in the case of any change to that information. No further impact on the operation of the regime is intended.

Consistent with the above-mentioned changes to the Patent Act regarding CSPs, 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 amendments to the Patent Rules include a number of miscellaneous amendments designed to improve the regulatory framework. For example:

Regulatory development

Consultation

Pre-consultation on proposed amendments to the Patent Rules and other regulations — Summer 2023

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 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 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 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 satisfied 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.

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

Consultation on proposed amendments to the Patent Rules and other regulations — Summer 2024

A 45-day online public consultation was launched on May 18, 2024, to solicit feedback from stakeholders on the proposed amendments to the Patent Rules and other regulations. Ten submissions were received.

Stakeholders generally opposed the $2,500 application for an additional term fee and the $1,000 maintenance fees. It was expressed that, because additional term is a remedial measure, applying for and maintaining the term should be free or low-cost, and that high fees such as proposed may disproportionately affect small businesses and independent inventors.

CIPO funds its operations on a cost-recovery model (i.e. operations are fully funded from revenue that is generated from client fees for intellectual property [IP] services). Therefore, it is imperative that fees charged are sufficient to recover the costs of CIPO’s activities in order to adequately sustain CIPO’s operations. Significant costs are associated with implementation of the additional term regime in Canada as well as the labour that will be required in determining and granting additional term durations. In order to ensure sustainability of the system under CIPO’s cost-recovery model, fees are remaining at $2,500 for the additional term fee and at $1,000 for the maintenance fee. To further address stakeholder concerns, the following refund provisions are being introduced:

Following the stakeholder reaction to the regulations in Canada Gazette, Part I, some further adjustments to the amendments to the Patent Rules are being made:

Some stakeholders expressed support for the level of detail provided in the proposed additional term amendments and for the objectivity in the determination of additional term. On the other hand, some stakeholders advocated for some subjectivity in determinations and objected to certain periods of time to be subtracted in the determination of additional term on various basis. Some preferred a simpler system with fewer periods of time to be subtracted. For example, some stakeholders were of the view that subtracting time to respond to notices would be unfair and punitive and would introduce unnecessary pressure on patent applicants to respond quickly. This is not in fact the case and additional term is meant to compensate for Patent Office delays, not applicant delays. One stakeholder expressed a desire for more opportunities for the Commissioner to exercise discretion in the determination of additional term; however, for consistency and predictability in determinations this was not desired.

With respect to the miscellaneous amendments, some stakeholders were not in favour of removal of an application from accelerated examination when the requirement for a request for continued examination is triggered by a third examination report. One stakeholder suggested that refunds should be available for certain fees paid while awaiting a due care decision from the Office when the result is a negative decision. In response, provisions are being introduced which make refunds available for certain fees that are paid if the Commissioner finds there was a lack of due care required by the circumstances.

Lastly, a number of submissions commented on matters specific to the amendments to the Patent Act and not the proposed Patent Rules amendments, including the Commissioners and Federal Court’s reconsideration authority to maintain or shorten the duration of additional term. While these concerns are beyond the scope of the consultation, it is noted that a determination of additional term may be subject to judicial review.

Modern treaty obligations and Indigenous engagement and consultation

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. As such, a detailed assessment is not required.

Regulatory analysis

Benefits and costs

Patentees, patent applicants, 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 these 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 amendments come into force on January 1, 2025, and the date the first eligible patents may receive an additional term occurs on or after December 2, 2025. Maintenance fee revenues for the 20th anniversary or later will not 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 2024–2025 to FY 2033–2034, there are expected to be 1 129 applications for an additional term and 51 applications for reconsideration of an additional term.

The volume of refunds related to a non-authorized request, for example if there were a typographical error in the patent number, for additional term are expected to be negligible. As a result, there are no monetized costs or benefits forecasted. Refunds related to the due-care requirement to reinstate an application or to reverse the deemed expiry of a patent are estimated to have a total volume of 239 during the forecast window.

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 innovations for Canadians.

Benefits to Government

There will 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 $2.08M. This includes revenues collected from domestic ($0.17M) and foreign ($1.90M) fee payers.

Benefits to patentees and patent applicants

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

Primarily, the additional term will 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 will 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 will benefit patentees operating internationally.

Refunds related to the due-care requirement to reinstate an application or to reverse the deemed expiry of a patent are estimated to return $5,488 to patentees and patent applicants.

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, when any person may freely make, use or sell the invention, competitors may enter the market, 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 innovations.

Canadians requesting reconsideration of an additional term will 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 will 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 additional term-related fees.

Costs to Government

As shown in Table 2 below, CIPO will incur $3.4M 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).

Refunds related to the due-care requirement to reinstate an application or to reverse the deemed expiry of a patent will cost approximately $0.05M over the 10-year forecast period. This includes administrative costs associated with providing the refunds.

Table 1: Monetized benefits (FY 2024–2025 to FY 2033–2034)
Impacted stakeholder Description of benefit 10-year total (present value) Annualized amount
CIPO Additional term fees revenue $2,076,796 $295,689
Patentees and patent applicants Refunds $5,488 $781
All stakeholders Total $2,082,284 $296,470
Table 2: Monetized costs (FY 2024–2025 to FY 2033–2034)
Impacted stakeholder Description of cost 10 year Total (present value) Annualized amount
Canadians and patentees Additional term fees $172,559 $24,568
CIPO Additional term implementation $3,441,392 $489,977
Refunds $59,444 $8,464
All stakeholders Total $3,673,395 $523,009
Table 3: Net Impact (FY 2024–2025 to FY 2033–2034)
Impacts Total (present value) Annualized value
Total cost $3,673,395 $523,009
Total benefit $2,082,284 $296,470
Net impact -$1,591,111 -$226,538

The negative net impact of the regulatory amendments is primarily due to the nominal cost recovery rate of 75% 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 those 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 under 100 employees). The 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 fees apply to optional services that small businesses and individuals are free to avoid. The total forecasted revenue from small entities for the 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.

Refunds related to the due-care requirement to reinstate an application or to reverse the deemed expiry of a patent are estimated to return $2,564 to small entities.

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 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 Patent Rules do not require applicants for an additional term to provide a calculation of estimated additional term entitlement, however given the application fee for an additional term, we expect that most stakeholders will undertake a preliminary analysis of the additional term eligibility prior to submitting an application. This analysis will result in administrative burden and potential costs for patent owners.

Regulatory cooperation and alignment

The United States (U.S.) 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 U.S. and Mexico, are described briefly below:

The U.S. approach results in a large percentage of patents receiving an additional term and for significant periods of time.

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

Effects on the environment

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 (GBA+) scan 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 the proposal will positively impact those who own and are employed by patent owners and negatively impact those who do not participate in the patent system. Therefore, amendments to the Patent Rules to implement the additional term framework 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 amendments will come into force on January 1, 2025.

It is anticipated that affected stakeholders will 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 may be eligible for an additional term, which represents additional time to prepare for the changes.

As part of the implementation, CIPO will notify stakeholders of the coming-into-force date of the amendments. Outreach will be proactive and conducted via different means including direct email and social media posts.

Service standards

In accordance with the Service Fees Act, CIPO will introduce service standards for fee-additional term services having an associated fee. 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 guidelines of 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: virginie.ethier@ised-isde.gc.ca