The availability of Patent Term Extensions (PTE) on patents pertaining to pharmaceutical and veterinary medicines was introduced in Canada in 2017 via amendments to the Patent Act along with the establishment of the Certificate of Supplementary Protection Regulations (CSP Regulations). Canada's regime provides for a period of up to two-years of term extension following patent expiry through the issuance of a Certificate of Supplementary Protection (CSP), provided certain criteria are met. CSP's are intended to compensate for delays in the regulatory approval of the medicinal ingredient associated with a patent.
What is a CSP?
A CSP is a form of sui generis protection for newly approved pharmaceutical products covered by an eligible patent.
The availability of a CSP is triggered by the approval of a new medicinal ingredient by Health Canada through the issuance of a Notice of Compliance (NOC) – the regulatory requirement to sell a medicine in Canada. Once a NOC has issued, a patentee has the ability to seek a term extension for a single patent pertaining to a medicinal ingredient or combination of medicinal ingredients. There are two types of eligibility requirements that must be satisfied for a CSP to issue, as discussed below.
A CSP is only available following the issuance of a NOC for a "new" medicinal ingredient. A medicinal ingredient will not be "new" if it has been previously approved in Canada or if it is a "variant" of a previously approved medicinal ingredient.
An ineligible "variant" is a medicinal ingredient which differs from a previously approved medicinal ingredient in one or more of the following ways:
- 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
- a variation that is an enantiomer, or a mixture of enantiomers, of a medicinal ingredient
- a variation that is a solvate or polymorph of a medicinal ingredient
- an in vivo or in vitro post-translational modification of a medicinal ingredient, and
- any combination of the variations set out above.
Assuming that the medicinal ingredient is considered "new", the patent for which the CSP is sought must "pertain" to this medicinal ingredient. This requires at least one patent claim to:
- the approved medicinal ingredient
- a product-by-process claim to make the approved medicinal ingredient, or
- an approved use of the medicinal ingredient.
The Federal Court has indicated that other claim types may also be eligible if the claims relate to subject-matter that impacts the performance of the active ingredient (e.g. certain formulation claims).
The CSP will apply to all patent claims even if only a subset of claims "pertains" to the medicinal ingredient.
There are two timing requirements that must be met for a CSP to issue.
The first timing requirement relates to filing the CSP Application form and paying the associated fee. The CSP Application must be filed, and the fee paid, within:
- 120 days from NOC issuance where the patent granted on or before the day the NOC issued, or
- 120 days from patent grant where the patent granted after the NOC issued.
The second timing requirement is that the Canadian New Drug Submission for the medicine must be filed in Canada within 12 months of the earliest regulatory filing in any of the following jurisdictions: the European Union and any member countries; the United States of America; Australia; Switzerland; and Japan. The intent of this requirement is to use CSP's to entice the rapid introduction of novel medicines into Canada.
Term and Protection Provided by the CSP
The term of a CSP is determined using the following formula:
CSP Term = [NOC approval date - Patent filing date] - 5 years
The term is capped at a maximum of 2 years.
The CSP only allows the patent to be enforced with respect to the specified medicinal ingredient during the CSP term, even if the patent covers additional products.
CSP's do not allow the patentee to take action against infringing activities that are related solely to the export of the medicinal ingredient.
A CSP does become associated with the underlying patent, and registered ownership will transfer along with that of the underlying patent. In addition, if the underlying patent is listed on the Patent Register under the PM(NOC) Regulations, the CSP will equally be listed.