As part of the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union, Canada has implemented European-style patent term extensions for certain drug products. Eligible patents can receive up to two years of additional protection, to offset delays in receiving marketing approval from Health Canada.
Similar to its European counterpart, these term extensions are provided in the form of a Certificate of Supplementary Protection (CSP), which takes effect on expiry of the underlying patent. Patentees must apply for this additional protection. To be eligible for a CSP, there must be an eligible regulatory filing, an eligible patent, and compliance with procedural requirements.
Eligible Regulatory Filings
The Notice of Compliance (NOC) granting approval for the sale of the drug in Canada must be issued by Health Canada after the Act to implement CETA came into force on September 21, 2017.
A CSP is available only for the first NOC issued by Health Canada for the sale of a drug containing a particular medicinal ingredient or combination of medicinal ingredients. When assessing whether an NOC is the “first” to issue, the following “variants” are treated as the same medicinal ingredient or combination of medicinal ingredients:
- an ester, salt, complex, chelate, clathrate, non-covalent derivative, enantiomer, mixtures of enantiomers, solvate, polymorph, in vivo or in vitro post-translational modification, or any combination; or
- a combination of medicinal ingredients that differs only in the relative proportions.
Nevertheless, human and veterinary approvals are considered separately and so a CSP may be available for a human drug that has previously been approved for veterinary use and vice versa.
If Canada was not the first country for which an application for marketing approval was submitted, the application for the NOC must have been filed in Canada within 12 months of the earliest foreign application for marketing approval in the USA, EU, Australia, Switzerland, or Japan. For NOC applications filed in Canada between September 21, 2017 and September 21, 2018, this period is 24 months.
Eligible Patents
To be eligible for a CSP, a patent must
- be in force (i.e. not expired or void);
- have a filing date on or after October 1, 1989; and
- contain at least one claim directed to one of:
- the medicinal ingredient (or combination) contained in the drug for which the NOC was issued;
- the medicinal ingredient (or combination) as obtained by a specified process (product-by-process) for which the NOC was issued; or
- the use of the medicinal ingredient (or combination) for which the NOC was issued.
Process claims and claims to dosages or formulations are not sufficient, on their own, to render a patent eligible for a CSP. Due to the way in which the term of the CSP is calculated (see below), the filing date of the patent should be at least 5-7 years before the NOC is issued.
Procedural Requirements
To obtain a CSP, the patentee must apply to the Minister of Health. The application for the CSP must be filed within 120 days of:
- the day on which NOC is granted, if the patent issued on or before that same date; or
- the day of patent issuance, if after the date NOC is granted.
There are no extensions of time available to file the application.
The application can only set out one patent. If a patentee has multiple eligible patents, it can select which patent to rely on. If a single NOC entitles multiple patentees to apply for a CSP, a conflict system exists to determine which patentee application has priority.
However, a patent which protects more than one medicinal ingredient or more than one combination would be eligible to support a CSP in respect of each of those medicinal ingredients or combinations.
The prescribed fee is $9,011 until April 1, 2018. After that date, the fee will increase annually by 2% of the previous year’s fee, rounded up to the nearest dollar.
Legal Effect
A CSP provides many of the same rights as a patent, including the right to block generic competition under Canada’s Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). There are, however, some notable limitations on the scope of the rights granted under a CSP, including:
- the CSP can only be enforced against a drug that contains the medicinal ingredient (or combination) set out in the CSP; and
- the CSP cannot be used to prevent the export of the medicinal ingredient (or combination) from Canada.
A CSP will be valid for a term of not more than two years, starting on the expiry of the underlying patent. The default term is calculated by subtracting five years from the period beginning on the filing date of the patent and ending on the day of the issuance of the NOC. This default term can be shortened by the Minister of Health if there was an unjustified delay in pursuing the NOC.
Canada’s new CSP system provides yet another layer of patent protection for innovators in the pharmaceutical industry, in addition to Canada’s data protection and PMNOC Regulations.