Additional Patent Term Rules

Summary#

These are final regulations that change the Patent Rules and three health-related regulations to add a new process for giving a patent an extra period of protection when issuance was unreasonably delayed. They set how to apply, what days count toward the extra time, the fees involved, and come into force on January 1, 2025.

What it does#

• Sets up the procedure for an additional patent term under the amended Patent Act:
  • One application per patent. The Commissioner sends a preliminary determination, there is a two-month period for observations, then a final certificate or dismissal.
  • The rules list many specific kinds of days that are subtracted when calculating how long the extra term should be. Overlapping days are only counted once.
• Creates a reconsideration process:
  • The Commissioner can review on their own motion. Any person may also apply for reconsideration; that process has its own form and fee rules.
• Introduces fees (standard and reduced “small entity” rates):
  • Application for an additional term: $2,500 (standard) or $1,000 (small entity).
  • Reconsideration application: $2,500 (standard) or $1,000 (small entity).
  • Maintenance fees for the 20th and each later anniversary (if the application/patent is still active): $1,000 (standard) or $400 (small entity).
  • Late fee for maintaining a patent during an additional term: $150.
  • Additional fee (when due care is required to reverse a deemed expiry): $289.19.
• Adds administrative and housekeeping changes to the Patent Rules, for example:
  • Rules for when underpayments or small-entity payments are “deemed” to have been paid and when extensions may be granted for unintentional underpayments.
  • Broader electronic communication rules and how receipt by an authorized service provider is dated.
  • Changes to who must receive certain notices (e.g., applicants, patentees, common representatives).
  • Clarifications about suspension of examination when fees are unpaid, and when claims added in error can be removed.
• Updates three health-related regulations so patent expiry dates used in drug-listing and certificate rules reflect any granted additional term:
  • Patented Medicines (Notice of Compliance) Regulations
  • Patented Medicines Regulations
  • Certificate of Supplementary Protection Regulations
• Service targets announced by the Office (not part of the Act but stated in the regulatory statement):
  • Aim to issue a certificate or dismissal for an additional-term application within 14 months.
  • Aim to decide reconsiderations within 14 months.
  • Target updates to the public patent database within 18 weeks after maintenance fees are paid.
  • Target certain due-care determinations within 6 months.

Who's affected#

• Patent owners and patent applicants. This is the main group who will use or pay for the new additional-term process.
• Small entities (defined in the rules) and universities — they get reduced fees.
• Patent agents and law firms that advise clients about filing and fee strategy.
• The Canadian Intellectual Property Office (CIPO) and staff who will administer the new process.
• Drug companies and regulators who use patent expiry dates in drug-listings and supplementary protection certificates, because expiry dates may change if an additional term is granted.
• The general public and downstream businesses may be indirectly affected because additional terms extend exclusivity for inventions; the regulations’ regulatory impact statement notes possible effects on access and prices.

If any group’s effect is unclear from the regulations, the regulatory statement spells out projected costs and revenues but not precise impacts on every stakeholder.

Why it matters#

• Canada is implementing a CUSMA obligation to allow patent owners to seek extra time when unreasonable delays occurred. That brings Canada in line with other major jurisdictions that provide some form of patent-term adjustment.
• For patentees who experienced long delays, an additional term can extend the period they alone can make, use, or sell an invention — that can matter a lot for high-value technologies and medicines.
• The rules also create predictable steps, deadlines and fees for applying, challenging, and maintaining any additional term. That affects cost and planning for inventors and businesses.
• The government predicts new fee revenue of about $2.08 million over 10 years but also about $3.44 million in implementation costs, producing a net projected cost to government of about $1.59 million over that period. The regulations include some refunds in limited situations and reduced fees for small entities.