Patents granted in Canada based on patent applications filed in the last couple of decades have been given terms of exclusivity of twenty years. The twenty year term starts from the date the patent application was filed in Canada, even if it takes several years to be examined and granted by the patent office or if the underlying products take time to be approved by the regulatory agencies.
That has now changed as part of compromises made during the negotiations for CETA, the trade agreement with Europe. Amendments to the Patent Act and implementing regulations came into force in September 2017 to provide for “Certificates of Supplemental Protection”, which can effectively extends the term of some patents.
Such certificates are generally available for patents directed to medicinal ingredients, or for combinations of medicinal ingredients, contained in a drug for which an authorization for sale has been obtained.
As of the date of writing this column, nine applications for such certificate have been filed. All of the applications are still marked as ‘pending’. See the Register of Certificates of Supplementary Protection (link) maintained by Health Canada for the latest status. There are important filing deadlines for any application for a Certificate of Supplementary Protection based on both the grant of the underlying patent but also the timing of market approval in Canada and in other jurisdictions.
The scope of protection during the period determined by a Certificate is generally the same as during the term of the patent:
115(1) The issuance of a certificate of supplementary protection grants the certificate’s holder and their legal representatives, during the certificate’s term, the same rights, privileges and liberties that are granted by the patent set out in the certificate, but only with respect to the making, constructing, using and selling of any drug that contains the medicinal ingredient, or combination of medicinal ingredients, set out in the certificate, by itself or in addition to any other medicinal ingredient.
An exception is that the a Certificate of Supplementary Protection does not prohibit the making, constructing, using or selling of the medicinal ingredient or combination of medicinal ingredients for the purpose of export from Canada.
The term of the supplementary protection is a maximum of two years, based on the date that the authorization for sale set out in the certificate is issued but may be discounted by any “period of unjustified delay” caused by the applicant’s failure to act.
116(3) The certificate’s term is calculated by subtracting five years from the period beginning on the filing date of the application for the patent and ending on the day on which the authorization for sale set out in the certificate is issued, but in any event is for a maximum of two years.
The Certificates of Supplementary Protection are available for both human use and veterinary use medicinal ingredients but as of this time, no applications have been filed for veterinary use.
Europe has used “Supplementary Protection Certificates” since the early 1990s in similar circumstances as the new Certificates of Supplementary Protection in Canada, although there are some implementation differences, including a maximum five year term in Europe.
Comparison are also likely going to be made between the Canadian Certificates of Supplementary Protection and patent term adjustments in the United States. Patent term adjustment is available in the United States to patents in any field of technology and is typically based on processing delays at the patent office although there are options to patent term adjustments based on regulatory approval delays. The length of patent term adjustment in the United States can be up to five years.
It will likely be some time before the impact of the Certificates of Supplementary Protection are felt in Canada. Due to the certificates being limited to patents directed to medicinal ingredients, the effect will be primarily felt in the pharmaceutical industry and the ongoing balance between brand and generic pharmaceutical companies.