The first anniversary of the certificate of supplementary protection (CSP) regime was 21 September 2018. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the time invested in researching and obtaining regulatory approval in Canada, followed from Canada's commitments under the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) (for further details please see "Publication of final regulations on patent linkage and term restoration related to CETA"). This article looks back on the previous year, recaps how the regime works and provides an update on CSPs granted and rejected to date.
A CSP grants the holder (which can notably be a company other than the market authorisation holder or related company) and its legal representatives the same rights granted by the patent set out in the CSP, but only with respect to the manufacture, construction, use and sale of any drug that contains the medicinal ingredient, or combination of medicinal ingredients, set out in the CSP, by itself or in addition to any other medicinal ingredient. A CSP can be granted for both small molecule (human and veterinary) and human biologic drugs. The rights cannot be enforced against uses for export.
A CSP takes effect on the expiry of the patent term. The CSP term is calculated by subtracting the patent filing date from the notice of compliance (NOC) date of issue, minus five years, to a maximum of two years. An NOC is the authorisation for sale in Canada.
CSPs can be enforced both within and outside actions under Canada's patent linkage regulations – the Patented Medicines (Notice of Compliance) Regulations. Once issued, if eligible, a CSP will be automatically added to the patent register by Health Canada for purposes of patent linkage litigation.
In very general terms, a CSP may be granted on application to Health Canada if:
- the patent contains a claim for:
- the medicinal ingredient or combination of all the medicinal ingredients in a drug, including in product-by-process form; or
- a use of the medicinal ingredient or combination of all the medicinal ingredients in a drug;
- the above drug is approved by Health Canada via an NOC;
- the NOC:
- issued on or after 21 September 2017;
- is the first approval for the drug at issue (for the single active or combination, as the case may be) or a prescribed variation thereof; and
- issued from a submission filed within 12 months of the filing of the first application for marketing approval of the medicinal ingredient or combination in the United States, Europe or any member country thereof, Japan, Switzerland or Australia (the transitional provision has now expired);
- the CSP application, including the current C$9,192 fee, is filed with Health Canada within 120 days from the later of the date of grant of the NOC and patent grant date;
- no prior CSP has issued for the medicinal ingredient or combination of medicinal ingredients or a prescribed variation thereof; and
- there is no conflict with a competing application, or the conflict has been resolved.
A chart comparing CSPs to European supplementary protection certificates is here.
As of 21 September 2018, Health Canada had granted 13 CSPs for drugs for human use and one for a veterinary drug; two applications were pending.
Health Canada had rejected three applications on the following bases:
- Rebinyn (coagulation factor ix (recombinant)), as the medicinal ingredient had "post-translational modification(s)" to medicinal ingredients in previously approved drugs, namely pegylation and different glycosylation patterns;
- Maviret (glecaprevir/pibrentasvir), as the NOC issued before 21 September, 2017 and the patent claims specify only one medicinal ingredient, whereas the drug at issue includes a combination of medicinal ingredients; and
- Shingrix, as the patent did not include an eligible claim – it includes formulation claims to the antigen and adjuvant.
GlaxoSmithKline has brought an application for judicial review of the rejection of the Shingrix application. One of the issues raised is whether both the antigen and adjuvant in Shingrix are medicinal ingredients.
In addition to patents and CSPs, small molecule (human and veterinary) and human biologic drugs approved in Canada that meet the definition of an 'innovative drug' are also protected by data protection (see Health Canada guidance here and Register of Innovative Drugs). An innovative drug is "a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph". A subsequent manufacturer seeking approval on the basis of a direct or indirect comparison to the innovative drug cannot file its submission until six years after the innovator drug's first approval and cannot receive approval until eight years after such approval, or eight-and-a-half years if the paediatric extension is granted.
In assessing the value of any potential CSP, its expiry relative to data protection expiry is key.
The CSP regime was a long-awaited complement to the existing forms of protection for pharmaceutical products in Canada. As the regime is still new, companies are reminded to consider applying for a potential CSP for any planned new product in Canada early in the lifecycle planning, including the one-year regulatory filing deadline. Prosecution of the patent should also be coordinated to ensure, if possible, that the patent grants before the NOC issues, as this may govern entitlement to the CSP in the event of a conflict with a competing application for a CSP.
For further information on this topic please contact Nancy Pei at Smart & Biggar/Fetherstonhaugh's Toronto office by telephone (+1 416 593 5514) or email (email@example.com). Alternatively, please contact Daphne Lainson at Smart & Biggar/Fetherstonhaugh's Ottawa office by telephone (+1 613 232 2486) or email (firstname.lastname@example.org). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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