As a part of its obligations under CETA, Canada plans to introduce patent term restoration for up to two years when research or regulatory delays have consumed part of the 20-year term of a pharmaceutical patent. Patent term restoration will occur via the grant of a so-called certificate of supplementary protection (“CSP”).
On July 15, 2017, the government of Canada published its proposed Certificate of Supplementary Protection Regulations (“CSP Regulations”) which, in conjunction with amendments to the Patent Act, will create the framework for the issuance of CSPs which will be administered by Canada’s Minister of Health. The government announced a 15-day consultation period with the release of the proposed CSP Regulations “to facilitate broader engagement on the proposed regulatory measures”.
The CSP regime will come into force concurrently with section 59 of CETA, which is tentatively expected on or around September 21, 2017.
Not all patents will be eligible for a CSP.
The patent specified in the CSP application must:
- Be in force at the time of the application for a CSP, and at the time of CSP grant.
- Have at least two years of its 20-year term remaining.
- Pertain to one medicinal ingredient (for drugs containing one medicinal ingredient) or a combination of all medicinal ingredients (for drugs containing two or more medicinal ingredients).
- Include at least one claim directed at: (a) the medicinal ingredient (or combination); (b) any use of the medicinal ingredient (or combination); or (c) the medical ingredient (or combination) as produced by a defined process.
The CSP Regulations prescribe several variations that would lead to medicinal ingredients being considered the same, including esters, salts, chelates, enantiomers, post-translational modifications, and other such variations.
A previously-issued patent may be eligible for a CSP.
Not all drugs will be eligible for a CSP.
To be eligible, the medicinal ingredient or combination must not have been in a drug previously authorized for sale in Canada, and must not be the subject of another CSP. Accordingly, once a patent for a particular drug has been issued a CSP, another patent relating to that same drug cannot be issued a CSP.
Eligible Regulatory Filings
Not all regulatory filings will be eligible for a CSP.
To be eligible, the Canadian regulatory filing must be made within 18 months of any application for marketing approval of the drug being filed in the USA, EU, Australia, Switzerland or Japan. This period will be shortened to 12 months one year after CETA comes into force, and is intended to incentivize the early availability of new drugs in Canada.
A regulatory filing approved before the CSP Regulations come into force may be eligible for a CSP.
A CSP will take effect after the normal expiry of the patent to which it corresponds. A CSP will effectively extend the term of the corresponding patent for up to two years, with some restrictions on what constitutes infringement.
The term of a CSP will be the difference between the filing date of the patent application and the date marketing authorization was first granted by Health Canada, less five years. In all cases the maximum term of a CSP will be capped at two years.
Effect on Litigation
A CSP can apply to a patent that is already the subject of an action pursuant to the revamped NOC Regulations. Likewise, actions for the infringement or impeachment of a CSP may be brought in a similar manner as those for a patent.
One difference, however, is that a CSP will not be infringed by the making, construction, use or sale of the medicinal ingredient for the limited purpose of export from Canada.
An application for a CSP must be filed within 120 days of: (a) the day on which marketing authorization is granted, if the patent issued on or before that same date; or (b) the day of patent issuance if after the date marketing authorization is granted.
The fee payable on filing an application for a CSP is $9,011. Beginning on April 1, 2018, the fee increases annually by 2% of the fee payable in the previous year.
To be eligible for a CSP, an applicant must ensure that:
- The Canadian regulatory submission is filed within 18 months of any application for marketing approval filed in the USA, EU, Australia, Switzerland or Japan.
- The CSP application is filed within 120 days of the date of the drug’s authorization for use, or the date of patent issuance, whichever is later.
- The medicinal ingredient or combination is not the sole ingredient or combination in a drug previously authorized for sale in Canada.
- The medicinal ingredient or combination is not the subject of another CSP.
- The patent is extant and has at least two years remaining in its term.
- The patent includes at least one claim directed at the medicinal ingredient or combination present in the drug product.
- The difference between the filing date of the patent application and the date of authorization for use is greater than five years.