Introduction

The amendments to the Patent Act and the enactment of the Certificate of Supplementary Protection (CSP) Regulations flowing from the Canada-EU Comprehensive Economic and Trade Agreement introduced a new framework in Canada for the issuance of CSPs (for further details please see "Publication of final regulations on patent linkage and term restoration relating to CETA"). CSPs provide an additional patent-like protection term and are intended to partly compensate innovators for the time required to research and obtain regulatory approval in Canada. CSPs are similar to the EU and European Economic Area supplementary protection certificates, with a number of key differences, including a capped term of two years compared with five years in the European Union.

Key aspects of CSP regime

Feature

Details

Protection

  • CSP.

Governing legislation

  • Patent Act (Sections 104 to 134).
  • CSP Regulations.

Guidance

  • Health Canada guidance document.

Register

  • Register of CSPs and Applications.

Drugs covered

  • Human small molecules.
  • Biologics.
  • Veterinary small molecules.

Term

  • From patent application filing date until notice of compliance (NOC) date, minus five years.
  • Capped at two years.

Paediatric extension

  • Not applicable.

Reduction in term

  • Possible if the NOC holder is also the patentee and the failure to act resulted in an unjustified delay in obtaining the NOC.

Eligible patent

  • Patent must include:
    • a product or product-by-process claim for the medicinal ingredient or combination of medicinal ingredients contained in an approved drug; or
    • a use thereof (whether the claimed use is approved or not).

Scope of protection

  • Same rights as for patents, but only with respect to the use, among other things, of "any drug that contains the medicinal ingredient, or combination of medicinal ingredients [and prescribed variations thereof], set out in the certificate, by itself or in addition to any other medicinal ingredient".
  • As an exception, CSPs do not apply to use, among other things, for export.

Assertable under Linkage Regulations

  • Yes – Patented Medicines (Notice of Compliance) Regulations.

Where application filed

  • Health Canada.

Deadline for filing application

  • Within 120 days from the later of the NOC date or the patent grant date.

Deadline for filing regulatory submission

  • One year from first regulatory submission filing for the medicinal ingredient or combination of medicinal ingredients in:
    • the European Union or any member country thereof;
    • the United States;
    • Australia;
    • Switzerland; or
    • Japan.
  • This is subject to a transitional provision of two years if the CSP application is filed by September 21 2018.

Protection by basic patent in force requirement

  • Not applicable.

First NOC/marketing authorisation requirement

  • A CSP application must be based on the first NOC (human or veterinary, as applicable) for the medicinal ingredient, combination of medicinal ingredients or prescribed variations thereof, provided that the NOC was granted on or after September 21 2017. Prior approvals for regular sale other than NOCs also preclude a CSP.

Number of CSPs per drug product

  • One.

Third-party filing

  • Yes, third-party filing is possible (ie, the patentee-applicant need not be the holder of the NOC and patentees can authorise the holder of an NOC to file on its behalf).

Priority determinations

  • Patent Act (Sections 108 to 111).
  • CSP Regulations (Section 11).
  • The highest priority is given to applications for patents granted on or before the NOC date.

Consideration of third-party observations during pendency of application review

  • It remains unclear whether Health Canada will consider any such observations.

Declaration of invalidity of CSP application/CSP

  • The Federal Court may declare a pending CSP application (only in the instance of another CSP application based on the same NOC and having same priority) or a CSP void.

For further information on this topic please contact Nancy Pei at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (nppei@smart-biggar.ca). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.

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