Patents granted in Canada have typically carried a 20-year term of protection from the date of filing, regardless of the time taken to be examined and granted by the Patent Office or for the underlying products to be approved by regulatory agencies. However, since September 2017, as part of concessions made during the negotiations for the Canada-European Union Comprehensive Economic and Trade Agreement, amendments to the Canadian Patent Act and the implementation of the Certificate of Supplementary Protection Regulations (Regulations) now provide for Certificates of Supplementary Protection (CSP). Canadian CSPs effectively extend the term of some patents directed to medicinal ingredients, or combinations of medicinal ingredients, contained in drug products for human and veterinary use, which products have experienced delays in regulatory approval.
The issuance of a CSP grants the certificate’s holder and their legal representatives the same legal 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 (but not for the purposes of exporting) of any drug product that contains the medicinal ingredient, or combination of medicinal ingredients.
The term of the supplementary protection is a maximum of two years, based on the date of authorization for sale of the drug product, but it may be discounted by any period of unjustified delay caused by the Applicant’s failure to act.
A list of CSP applications and their status is available on the Health Canada website and information regarding the patents to which the CSP applications relate is available on the Canadian Intellectual Property Office website.
Currently, thirteen CSP applications for human use have been filed since the Regulations came into force in September 2017. Out of the thirteen applications, four have been issued, providing the maximum of two years of extended protection, while one application has been refused, presumably on the basis that the subject patent relates to a single medicinal ingredient, whereas the underlying drug product contains a combination of medicinal ingredients.
The issuance of Canadian CSPs is great news for pharmaceutical patentees looking to recoup some of the patent term lost to delays in regulatory approval of their drug products. However, there are important eligibility requirements and filing deadlines for any CSP application based on the subject matter of the patent and the timing of its grant and the underlying drug product and the timing of its market approval in Canada and in other jurisdictions. Contact us for assistance in navigating these new Regulations.