Part INoticeVolume 158, Number 20Published: May 18, 2024

Rules for Additional Patent Term

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

Proposed regulations implement an "additional term" framework under the Patent Act to compensate patentees for unreasonable delays in issuing patents, as required by CUSMA. They set the application and reconsideration procedures (including a two‑month observation period), limit one application per patent, establish fee amounts and maintenance fees during any additional term, and amend related medicines and supplementary protection regulations. The regulations are proposed to come into force on 2025-01-01 and apply to patents from applications filed on or after 2020-12-01.

Published
May 18, 2024
Department
Unavailable
Section
REGULATORY IMPACT ANALYSIS STATEMENT
Comment deadline
Unavailable
Effective date
January 1, 2025
Publication part
Part I

Summary

Summary#

These are proposed regulations to add rules for giving patent owners extra patent time when Canadian patent examiners take too long. They fill in details for the amended Patent Act and change the Patent Rules, set fees, and update related rules for medicines. The changes are planned to come into force on January 1, 2025 and are part of Canada’s obligations under CUSMA (Canada–United States–Mexico Agreement).

What it does#

  • Sets up how a patent owner can apply for an extra patent term when the patent was issued after an unreasonable delay.
  • Describes the step-by-step decision process for the extra term, including a preliminary decision, a two‑month period for comments, and a final certificate if granted.
  • Defines how many days of delay are counted by listing many specific periods that can be subtracted from the delay calculation.
  • Allows one application for an additional term per patent.
  • Creates a process for anyone to ask the Commissioner to reconsider an extra-term decision (with a formal application, fee, and a two‑month comment period).
  • Sets fees:
    • Application or reconsideration fee: $2,500 (standard) or $1,000 (small entity).
    • Maintenance fee during an additional term for each 20th and later anniversary: $1,000 (standard) or $400 (small entity).
    • Late fee: $150.
    • Additional fee for reversing expiry: $289.19.
  • Amends the Patented Medicines (Notice of Compliance) Regulations, the Certificate of Supplementary Protection Regulations, and the Patented Medicines Regulations so patent expiry dates will reflect any granted additional term.
  • Includes a set of housekeeping changes to the Patent Rules (examples: wider electronic communication options, rules about who can communicate with the Patent Office, and how certain fees and suspensions affect examination).

Who's affected#

  • Patent owners and applicants who filed on or after December 1, 2020 and who get their patents issued after long delays.
  • Intellectual property practitioners, including patent agents and small IP firms.
  • Drug companies and others who must report patent expiry dates under medicines regulations.
  • Canadian Intellectual Property Office (CIPO), which will run the new application and reconsideration processes and collect the fees.
  • Small businesses and individual inventors: the rules offer discounted “small entity” fees but will still impose new costs and paperwork.
  • Estimated impacts from the regulatory analysis: about 1,129 applications for an additional term and 51 reconsideration applications over 10 years (government forecast).

Why it matters#

  • An extra patent term extends the period a patentee can block others from making, selling, or using an invention. That can protect inventors who waited years for a patent.
  • For consumers and competitors, extra terms can delay lower‑cost competition (including generic drugs) and could mean higher prices or slower access to cheaper versions.
  • The rules set predictable steps, limits, and fees for asking for extra time. That helps businesses plan and helps Canada meet its international trade obligations under CUSMA.
  • Financially, fee revenue is expected to be $2.08 million over 10 years, while CIPO’s implementation costs are estimated at $3.44 million, giving a net fiscal impact of about -$1,537,155 over that period (government estimate).
  • These are proposed regulations (not yet law). The public could comment during the consultation period of 45 days after the notice was published.

Key topics

Patent ActPatent RulesCanada–United States–Mexico AgreementCUSMAPatented Medicines (Notice of Compliance) RegulationsCertificate of Supplementary Protection RegulationsPatented Medicines RegulationsCanadian Intellectual Property OfficeInnovation, Science and Economic Development Canadaadditional patent termapplication fee $2,500small entity fee $1,000maintenance fee $1,000December 1, 2020

Source: Canada Gazette

Official source