As part of its obligations under the Canada-European Union Comprehensive Economic and Trade Agreement which came into force on September 21, 2017, Canada has introduced a patent term restoration regime for drugs containing a new medicinal ingredient, or a combination of new medicinal ingredients, through the implementation of Certificates of Supplementary Protection (CSPs). A CSP allows for a patent term extension of up to two years from the expiry date of a patent that meets the eligibility and timing requirements. There are also timing requirements with respect to the filing of the New Drug Submission in Canada for the relevant drug product if an application for an authorization for sale has been previously made in one or more specified countries. A CSP register is being maintained by the Minister of Health and can be found here.
To be eligible for a CSP, the patent must have been filed after October 1, 1989, and be in force. The patent must also pertain to a medicinal ingredient or to a combination of medicinal ingredients in a drug for which a Notice of Compliance (NOC) was issued in Canada after September 21, 2017.
A patent pertains to a medicinal ingredient (in the case of a drug containing only one medicinal ingredient) or to a combination of medicinal ingredients (in the case of a drug containing more than one medicinal ingredient) if it contains at least one claim for:
- the medicinal ingredient or combination of all the medicinal ingredients;
- the medicinal ingredient or combination of all the medicinal ingredients as obtained by a specified process (“product-by-process”); or
- the use of the medicinal ingredient or combination of all the medicinal ingredients.
Patents containing pure process claims or formulation claims are therefore not eligible for a CSP. Neither are patents with claims directed to only one of the medicinal ingredients in a combination drug.
Only one CSP will be granted with respect to a medicinal ingredient or to a combination of medicinal ingredients, and that medicinal ingredient or combination of medicinal ingredients must not have been previously approved in Canada. In other words, the NOC must be the “first” authorization for sale of that medicinal ingredient or combination of medicinal ingredients in a drug in Canada.
For the purposes of obtaining a CSP, a medicinal ingredient that is a variation of a previously approved medicinal ingredient will be considered to be the same medicinal ingredient. For example, an ester, salt, complex, chelate, clathrate, noncovalent derivative, enantiomer, mixture of enantiomers, solvate, polymorph, or in vivo or in vitro posttranslational modification of a medicinal ingredient or any combination of these variations will be considered to be the same medicinal ingredient.
Additionally, an application for a CSP can only apply to one patent. A given patent, however, may be eligible for multiple CSPs, if it pertains to multiple medicinal ingredients or combinations that correspond to different NOCs.
Term and Scope
The term of a CSP is calculated as follows:
Term = ([A – B] – 5 years), but not to exceed 2 year, where
A = Date of issuance of the NOC
B = Filing date of the Canadian Patent
The scope of the CSP is limited to the making, constructing, using and selling of a drug that contains the medicinal ingredient or combination of medicinal ingredients set out in the CSP, and does not extend to exports, i.e. it will not be an infringement of the CSP to make, construct, use or sell the medicinal ingredient or combination of medicinal ingredients for the purpose of export from Canada.
An application for a CSP must be filed within 120 days from the day on which the NOC was issued if the relevant patent has already been granted, or within 120 days from the day on which the relevant patent issues, if it was pending when the NOC was granted.
If a drug submission has been previously submitted in one or more of the following countries:
- the European Union (and any country that is a member of the European Union),
- the United States of America,
- Switzerland, or
the drug submission must be filed in Canada within 12 months of the first such foreign application in order for a patent to be elgible for a CSP. A transition provision, however, provides for a 24 month period for filing an NDS in Canada from the date of the first relevant foreign application if the application for the CSP is filed within the first year of the implementation of CETA (i.e., before September 21, 2018).
Application Details and Fees
The application form for a CSP is available from the Health Canada website.
The form includes the requirements for the contents for an application for CSP as stipulated by the Patent Act and the Certificate of Supplementary Protection Regulations, including:
- The patent number, the filing date of the patent in Canada, the issuance date the patent, and the date of patent expiry,
- The applicant’s name and contact information in Canada (complete address),
- An attestation by the applicant that they are the patentee and recorded owner of the patent or that they area the authorized manufacturer,
- The medicinal ingredient or combination of medicinal ingredients related to the CSP,
- The NDS identification number related to the CSP, and
- An attestation by the applicant that either no application for authortization for sale has been made in one of more the prescribed countries as noted above, or that if an application for authortization for sale has been made in one of more the prescribed countries then the application for authorization for sale in Canada was filed within the specified time.
The prescribed application fee for a CSP is currently $9,011.00. The fee will increase 2% annually, beginning on April 1, 2018.
Order of Priority, Conflicts and Declaration of Non-Compliance Proceedings
Since only one CSP can be granted for a given medicinal ingredient or combination of medicinal ingredients, the Patent Act outlines a priority scheme for those situations where more than one application for a CSP has been filed with respect to the same authorization for sale, as follows:
- An application for a CSP in respect of a patent that was granted on or before the day the NOC was issued will have the same priority as any other such application.
- An application for a CSP in respect of a patent that was granted on or before the day the NOC was issued will have priority over applications in respect of a patent granted after the day the NOC was issued.
- Among applications for a CSP in respect of patents granted after the day the NOC was issued, the patent with an earliest grant date will have priority.
The issuance of a CSP in relation to an application with higher priority will cause applications for a CSP with lower priority to expire.
In those cases where two or more applications for CSPs have the same priority, a written notice will be sent to each applicant advising of the conflict. Applicants receiving such a notice can seek a declaration that a conflicting CSP application is invalid or void in the Federal Court for non-compliance with the CSP application and approval requirements. A proceeding to obtain such a declaration must be commenced within 90 days from the date of the written notice. The CSP applicant commencing the proceeding (or appeal thereof) must provide notice of the proceedings to the Minister of Health.
If after the non-compliance proceedings, two or more conflicting CSP applications are still pending (e.g., the Court does not find one of them to be non-compliant), then those CSP applications will expire 30 days from the last day any of the proceedings is finally disposed of. If, on the other hand, non-compliance proceedings are not commenced and two or more conflicting applications are still pending at the end of the 90 day notice period, all of those applications will be deemed to have expired. In other words, if a conflict between two or more conflicting CSP applications is not resolved, either as a result of a Court proceeding or withdrawal of one or more CSP applications, none of the conflicting CSPs applications will receive approval for a CSP.
CSP Issuance and the Register of Certificates of Supplementary Protection and Applications
The Minister of Health must maintain a register of applications for CSPs and granted CSPs.
For CSP applications, the register provides the patent number, the date of patent expiry, the medicinal ingredient or combination of medicinal ingredients, the NOC identification number and whether it is for human or veterinary use.
In the case of issued CSPs, the register provides the patent number, the medicinal ingredient or combination of medicinal ingredients, the NOC identification number, the CSP identification number, the day on which the term of the CSP begins and the day on which it ends, and whether it is for human or veterinary use.
The Minister will issue a CSP once the 120 day period to file an application has ended provided all requirements for the application for a CSP have been satisfied and there are no conflicting CSP applications or related court proceedings.