Part INoticeVolume 158, Number 20Published: May 18, 2024
Additional Patent Term Rules
Canada Gazette, Part I, Volume 158, Number 20: Regulations Amending the Patent Rules and Certain Regulations Made Under the Patent Act
REGULATORY IMPACT ANALYSIS STATEMENT
Key facts
- Published
- May 18, 2024
- Comment deadline
- July 2, 2024
- Effective date
- January 1, 2025
Summary#
This is a proposed change to the Patent Rules and related regulations to put detail around a new “additional patent term” created by recent changes to the Patent Act. The rules explain who can get extra patent time when Canada takes too long to issue a patent, how that extra time is calculated, how to challenge it, and the fees involved. The proposal is scheduled to come into force on January 1, 2025 and is open for comment for 45 days after publication.
What it does#
- Implements the additional-term framework required by the Canada–United States–Mexico Agreement (CUSMA) for applications filed on or after December 1, 2020.
- Sets a step-by-step process for applying for an additional patent term:
- One application per patent.
- Commissioner will send a preliminary duration, allow a two-month observation period, then issue a certificate or dismiss the application.
- First patents could become eligible on December 2, 2025 or after.
- Explains how the extra time is calculated:
- The rules list many specific time “periods” whose calendar days are added up and then subtracted from the delay.
- Overlapping days count only once.
- The rules include applicant-caused delays and some non‑CIPO delays among the periods that can be subtracted.
- Creates a formal reconsideration process so anyone can ask the Commissioner to shorten a granted additional term:
- Reconsideration requires a written application, a fee, a preliminary determination and a two-month observation period.
- Sets fees (with reduced rates for small entities):
- Application for additional term: $2,500 standard / $1,000 small entity.
- Reconsideration application: $2,500 standard / $1,000 small entity.
- Maintenance fee during an additional term (for each 20th and subsequent anniversary): $1,000 standard / $400 small entity.
- Late maintenance fee: $150.
- Additional fee for reversing deemed expiry: $289.19.
- Makes consequential changes to:
- Patented Medicines (Notice of Compliance) Regulations
- Certificate of Supplementary Protection Regulations
- Patented Medicines Regulations These changes ensure patent expiry dates shown to Health or other regulators reflect any granted additional term.
- Miscellaneous and housekeeping changes to the Patent Rules:
- Allow limited extensions if an examination fee was unintentionally underpaid.
- Broaden acceptable electronic communications beyond email.
- Clarify how communications from unappointed agents are handled.
- Allow suspension of examination when late maintenance fees place an application in a “late period.”
- Other small clarifications to reduce administrative confusion.
Who's affected#
- Patent owners and applicants, both foreign and Canadian. The government forecasts 1,129 applications for additional term and 51 applications for reconsideration over a 10‑year period.
- Small businesses and individual inventors who qualify as “small entities.” The rules offer lower fee rates to small entities.
- Canadian Intellectual Property Office (CIPO), which will administer the new process and bear implementation costs.
- The pharmaceutical and life‑sciences sectors in particular, because patent expiry dates affect drug market exclusivity and related regulatory lists.
- Canadian consumers and businesses that rely on competition after patent expiry. It is unclear which specific patents will receive extra time; eligibility depends on the days-subtracted calculation and CIPO’s processing.
Why it matters#
- Fulfils Canada’s trade commitment under CUSMA and aligns Canada with other major patent offices that offer remedies for long patent office delays.
- Gives patentees a legal route to get extra monopoly time when a patent was granted late. That can help firms recover value lost to long processing times and may influence investment decisions.
- It could raise the cost of some products, including medicines, because extended patent terms delay generic or competing entry.
- The government expects some revenue from new fees ($2.08 million over 10 years) but also estimates implementation costs for CIPO at $3.44 million, giving a net present‑value impact of about −$1,537,155 over 10 years (using the analysis in the proposal).
- This is a proposal, not final law. The public can comment during the 45‑day consultation window before final regulations are made.
Key topics
Patent ActPatent RulesCanada–United States–Mexico AgreementCUSMACertificate of Supplementary Protection RegulationsPatented Medicines (Notice of Compliance) RegulationsPatented Medicines RegulationsCanadian Intellectual Property OfficeInnovation, Science and Economic Development Canadaadditional patent termcertificate of additional termpatentsintellectual propertypharmaceutical exclusivity
Source: Canada Gazette