Canada previously stood apart from many other major industrialized nations in its failure to grant additional patent term for drug patents due to delays resulting from regulatory approval. The United States, Japan and Australia are examples of countries that presently have such adjustments to the terms of drug patents. That has changed just recently in light of a new statutory and regulatory framework that came into force on September 21, 2017 in order for Canada to fulfill its obligations under the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union. If eligible, the term of a patent can be extended by up to two years.
The additional patent term will be granted by way of a Certificate of Supplementary Protection referred to as a “CSP”. The grant of a CSP will be administered by the Minister of Health and is available not only to medicines intended for human use, but also for veterinary medicines. While the new statutory and regulatory provisions will be welcomed by many pharmaceutical patent holders, there are a number of caveats that should be noted with respect to the specific deadlines that must be met with respect to a submission to Health Canada, which patents are eligible for the increases in patent term, and the precise length of the additional term granted.
Deadline – only 120 days
- The window for applying for a CSP is relatively narrow. The deadline set by the Patent Act and Patent Rules is the later of 120 days from the date of either: (i) the issuance of the patent, or (ii) the grant of the Notice of Compliance (NOC). For example, if a patent has already issued as of September 21, 2017 and a NOC is subsequently granted, the deadline for submission of the CSP application is 120 days from the later NOC grant date. Conversely, if a NOC grants (after September 21, 2017) and the patent later issues, the deadline for submission of the CSP application is 120 days from the later patent issue date. However, if a NOC has already been granted before September 21, 2017, the patent will not be eligible for a CSP application (more below).
- Only one medicinal ingredient is eligible for a CSP. A second CSP cannot be obtained for the same medicinal ingredient or new combinations of medicinal ingredients that differ only with respect to “prescribed variations” as set out in the regulations. One example of a “prescribed variation” is 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. Details of other prescribed variations can be found in the regulations, which are set out in the Canadian government link below.
- Pure process patents are not eligible for additional term, nor patents directed to a formulation. However, eligibility for a CSP is not limited to product claims. Availability extends to use claims (use of the medicinal ingredient) and product-by-process claims as well.
As noted, the CSP regulations are not retroactive to previous NOC approvals. This means that if a Notice of Compliance is authorized before September 21, 2017, the medicinal ingredient covered by the patent will not be eligible for any term extensions. However, if you receive a Notice of Compliance on or after this date for a patent application that we have already reported as being allowed or issued, then such patent may be eligible for an increase in its patent term.
- The patent must be in force at the time of the application for a CSP and at the time of grant of the CSP. The patent must contain at least one claim to the same medicinal ingredient (including use and product-by-process claims as noted above)
- It is also important to note that if an application for marketing approval is not timely filed, then the patent will not be eligible for a CSP. In this connection, the Canadian application for marketing approval must be submitted within a certain period from which marketing approval was previously applied for in a prescribed jurisdiction or country. This includes the following: the European Union or any member country, the United States, Australia, Switzerland or Japan. The prescribed period for filing the application for the authorization for sale in Canada from when a previous submission was filed in one of these countries is
- (i) 24 months, if the application for a certificate of supplementary protection was filed no later than the first anniversary of the day on which section 59 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act comes into force, and
- (ii) 12 months, in any other case.
In other words, the deadline is 24 months for a CSP application filed during the first year the CSP regime comes into force.
- The term of the patent is adjusted by no more than two years. The actual number of additional days added to the term depends on the time that has elapsed between the patent filing date and the NOC date – the longer the period of time that has elapsed between these dates, the longer the term granted, but such term cannot be longer than the two year maximum that is available. The calculation below is used to determine the precise number of days that are added.
CSP term = [(NOC date – Patent filing date) – 5 years] but not to exceed a 2 year maximum.
Notwithstanding, the Minister of Health has been given the discretion to decrease the term available according to the above formula if it is considered that there was unjustified delay in the process of obtaining the authorization for sale (NOC).
Moreover, it should be mentioned that there is a fee of $9,011 for applying for a CSP. This fee is subject to a 2% increase each year.
Finally, please note that the purpose of this article is not to provide legal advice for any particular case, but rather to make our clients generally aware of the new statutory and regulatory regimes in Canada available to increase the terms of eligible drug patents. We further wish to emphasize that continual monitoring of the issuance of a Notice of Compliance for Canadian patents is recommended. Typically such monitoring would be conducted by in-house counsel.
We encourage you to review the following link for more detailed information:
Certificate of Supplementary Protection Regulations – Vol. 151, No. 28 — July 15, 2017: