Canada implemented the Comprehensive Economic and Trade Agreement (CETA) with the European Union on 21 September 2017. As a result, patent term extension of up to two years is now available for patents pertaining to new medicinal ingredients or new combinations of medicinal ingredients for human or veterinary use.
What Protection is Available
Patent term extension is provided in Canada in the form of a Certificate of Supplementary Protection (CSP). A CSP is available only for the first authorization for sale of a drug containing a new medicinal ingredient or combination of medicinal ingredients in Canada. An authorization for sale is specifically defined as a Notice of Compliance (NOC) issued by Health Canada, and interim orders or limited purpose authorizations are not counted. Thus, for a drug to be eligible for a CSP, the drug must not have been previously authorized for sale in Canada by issuance of a NOC. However, a drug authorized for human use and a drug authorized for veterinary use are treated separately, so that two separate CSPs would potentially be available, one for each of these different uses.
Additionally, each application for a CSP may set forth only one patent. Thus, the term of only one patent can be extended in respect of each new medicinal ingredient or combination of medicinal ingredients for which a NOC is obtained in Canada. However, the converse does not apply: if a patent covers multiple new medicinal ingredients or combinations thereof, Health Canada will consider multiple applications for a CSP based on that patent.
There are also limitations on what constitutes the same medicinal ingredient or same combination of medicinal ingredients for purposes of applying for a CSP: for example, esters, salts, complexes, chelates, clathrates, non-covalent derivatives, enantiomers, mixtures of enantiomers, solvates, polymorphs, in vivo or in vitro post-translational modifications, or any combination of such variations of a medicinal ingredient, are all considered to be the same medicinal ingredient for the purposes of determining eligibility for a CSP. Additionally, combinations that differ only in the relative proportions of the medicinal ingredients are considered to be the same. The same definitions apply in determining whether a patent covers a particular medicinal ingredient or combination of medicinal ingredients covered by a NOC. Thus, for example, where a patent contains claims directed only to a particular compound but the approved product is a specific salt thereof, an application for a CSP will still be possible.
To be eligible for a CSP, a patent must contain at least one claim directed to one of:
- the medicinal ingredient or combination of all medicinal ingredients contained in the drug for which the NOC was issued;
- the medicinal ingredient or combination of all medicinal ingredients as obtained by a specified process (product-by-process) and contained in the drug for which the NOC was issued; or
- a use of the medicinal ingredient or combination of all medicinal ingredients contained in the drug for which the NOC was issued.
Patents containing only pure process claims are not eligible, since the process claim is not considered to protect the medicinal ingredient or combination of medicinal ingredients. Also, claims directed to formulations containing the medicinal ingredient are not considered to protect the medicinal ingredient or combination of medicinal ingredients per se, and so a patent containing only these types of claims would not be eligible to support a CSP.
Procedurally, to be eligible for a CSP, the relevant patent must be in force, and the application for the patent must not have been filed prior to 1 October 1989 (i.e. the date when Canada changed to a fixed patent term based on the filing date of the application rather than the grant date). Also, the NOC for the corresponding drug must have been granted after 21 September 2017, when the new provisions providing for CSPs came into force.
Term and Scope of Protection
The term of a CSP will be calculated as follows: [date NOC issued] minus [date of filing patent application] minus [five years], but is capped at a maximum of two years. The Minister of Health has discretion to reduce the term of a CSP by any period that the Minister considers that the patentee’s failure to act resulted in a period of unjustified delay in the process of obtaining the NOC.
The rights conferred by a CSP are commensurate in scope with the patent, but only with respect to making, using and selling any drug that contains the medicinal ingredient or combination of medicinal ingredients set out in the CSP, whether alone or in combination with other medicinal ingredients. There is also an exception to those rights permitting manufacture for the purpose of export from Canada.
When to Apply
The deadline to apply for a CSP is 120 days from the grant of the NOC (if the patent is granted before the NOC is granted) or 120 days from the grant of the relevant patent (if the NOC is granted before the patent is granted).
In addition to this deadline, there is a timeliness requirement for making the application for a NOC in Canada in order to be eligible to apply for a CSP. Where an application for marketing approval has been submitted in any one of: the European Union, a country that is a member of the European Union, the United States, Australia, Switzerland or Japan, the application for a NOC in Canada must be submitted within twelve months of the first such application for marketing approval.
A transitional exception is provided for applications for CSPs that are filed by 21 September 2018: in such cases, the application for a NOC in Canada must be submitted within twenty-four months of the earliest application for marketing approval in any of the above-listed countries.
The government application fee for a CSP is initially set at $9,011, and will increase by 2% per year.
The addition of patent term extension in Canada to help compensate patent owners for delays in obtaining regulatory approval to sell new drugs brings Canada’s patent system into better alignment with those of its major trading partners. It also adds new complexities for patent owners to ensure that the requirements for obtaining a CSP are timely complied with.