Canada Edges Toward Patent Term Extension

On July 15, the Government of Canada published its proposed Certificate of Supplementary Protection Regulations (Regulations), which—as part of the effort to implement Bill C-30's requirements related to the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union—is moving Canada closer toward a patent term extension.¹

The proposed Regulations are not law; the government is inviting comments until July 30. The 15-day comment period is unusually short, suggesting the federal government wants to move quickly to implement patent term extension. The Regulations will become law once registered or once the legislation implementing CETA comes into force (whichever is later). This bulletin provides an overview of the proposed Regulations.

What You Need To Know

• A certificate of supplementary protection extends the term of a patent for a drug that contains the medicinal ingredient or combination of medicinal ingredients set out in the certificate.
• Eligibility for extension. To be eligible for patent term extension, a patent must claim:
  • the medicinal ingredient or combination of all the medicinal ingredients contained in the drug (i.e., a "product" claim);
  • the medicinal ingredient or combination of all the medicinal ingredients as obtained by a specified process and contained in the drug (i.e., a"product-by-process" claim); or
  • a use of the medicinal ingredient or combination of all the medicinal ingredients contained in the drug (i.e., a "use" claim).
• Length of extension. The extension will be up to a maximum of two years, which will take effect on expiry of the original term of the patent set out in the certificate.
• Application timing. An application for a certificate must be filed
  • before the end of 120 days beginning from the later of:
    • either the day on which an authorization for sale that is a notice of compliance (NOC) in relation to which the certificate is sought is issued; or
    • the day on which the patent is granted; and
  • more than two years before the expiry of the term of the patent.
• NOC must be the first authorization for sale with respect to the medicinal ingredient or combination of medicinal ingredients.
• Marketing approval. The application for a certificate must certify either no application for marketing approval for the medicinal ingredient or combination of medicinal ingredients has been filed in specified foreign countries, or the application for the NOC has been filed within 12 months of the date of the first application for marketing approval for the medicinal ingredient or combination of medicinal ingredients in specified foreign countries.
• When can certificates be issued? A certificate can only be issued in relation to a NOC that issues on or after the day on which the law comes into force, therefore:
  • new drug submissions pending on the day the law comes into force will be eligible to support certificates of supplementary protection; and
  • marketed drugs having received a NOC before the law comes into force will not support certificates of supplementary protection.

Scope of Rights

The current term of a patent in Canada is 20 years. Under the Regulations, a certificate would extend this term—specifically, the exclusive right granted under a patent to make, construct, use and sell a drug that contains the medicinal ingredient or combination of medicinal ingredients set out in the certificate. There is an exception to allow a person to practice the claimed invention for the purpose of export from Canada without infringing the certificate.

Term of Rights

A certificate will take effect on expiry of the original term of the patent. The "extended" term of protection offered by the certificate will equal the lesser of (i) the period between the filing date of the patent and the date on which the NOC in relation to which the certificate is sought is issued, less five years, or (ii) two years. "Unjustified" delays attributed to a patentee's failure to act in moving a regulatory submission forward may result in the period of protection being reduced.

Requirements to Obtain a Certificate

Only one certificate will be issued with respect to a medicinal ingredient or combination of medicinal ingredients contained in a drug.

The Regulatory Impact Analysis Statement that accompanies the Regulations indicates that a patent which protects more than one medicinal ingredient or more than one combination of medicinal ingredients would be eligible to support a certificate in respect of each of those medicinal ingredients or combinations.

Significantly, the certificate can only be issued in relation to an NOC issued on or after the day on which the law comes into force. This means new drug submissions pending the day the law comes into force will be eligible to support certificates of supplementary protection. Marketed drugs having received a NOC before the law comes into force will not support certificates of supplementary protection. The NOC must additionally be the first authorization for sale with respect to the medicinal ingredient or combination of medicinal ingredients.

Where there are multiple applications for certificates in respect of the same NOC, a certificate will issue for the application setting out the earliest "priority" which, according to Bill C-30, will be based on the relative grant dates of the patents specified in each application for certificate.

Submission Deadlines

An application for a certificate must be filed before the end of 120 days beginning from the later of either the day on which the NOC in relation to which the certificate is sought is issued or the day on which the patent is granted. Furthermore, an application for a certificate must be filed more than two years before the expiry of the term of the patent.

In addition, an application for a certificate must contain an attestation that—if an application for marketing approval has already been filed in the European Union or any member country, as well as the United States, Australia, Switzerland, or Japan for the medicinal ingredient or combination of medicinal ingredients—the Canadian NOC application has been filed within 12 months from the first such foreign application filing date. The proposed Regulations include a transitional period in which the period for timely submission is lengthened to 18 months, if the application for a certificate was filed no later than the first anniversary of the day on which the legislation implementing CETA comes into force.

Same Medicinal Ingredients

Medicinal ingredients contained in drugs will be treated as being the same medicinal ingredient if they differ from each other only with respect to:

(i) a variation in any appendage within the molecular structure of a medicinal ingredient that causes it to be an ester, salt, complex, chelate, clathrate or any non-covalent derivative;

(ii) a variation that is an enantiomer, or a mixture of enantiomers, of a medicinal ingredient;

(iii) a variation that is a solvate or polymorph of a medicinal ingredient;

(iv) an in vivo or in vitro post-translational modification of a medicinal ingredient; and

(v) any combination of the above variations.

The word "appendage" is intended to refer to a portion of the molecule that is connected or joined to a larger or more important part and is meant to signify the non-principal part of the molecule which is not principally responsible for the mechanism of action. These provisions are meant to ensure relatively minor variations in medicinal ingredients cannot be used to circumvent the scope of protection granted by an issued certificate, or the eligibility requirements relating to the first authorization or timely submission.

Actions for Infringement and Impeachment

An action for infringement based on a certificate may be brought in the same manner as an action for the infringement of a patent. Furthermore, a certificate, or any claim in the patent referred to in such a certificate, may be declared invalid or void by the Federal Court.

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¹ See: http://canadagazette.gc.ca/rp-pr/p1/2017/2017-07-15/html/reg16-eng.php