This article provides an updated summary of approvals, rejections and pending applications, as well as further reminders and tips.
As of 21 September 2019, Health Canada had granted 31 (18 in the second year) CSPs for drugs for human use and two for veterinary use; three applications were pending. Of the issued CSPs, 28 have the maximum two-year term. Health Canada's statistical report for CSPs also provides statistics, but covers the fiscal year ending on 31 March 2019.
Health Canada has rejected eight applications to date on the following bases(3):
- Rebinyn (coagulation factor IX (recombinant), pegylated) was rejected 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) was rejected as the notice of compliance (NOC) was issued before 21 September 2017 and the patent claims specify only one medicinal ingredient,(4) whereas the drug at issue includes a combination of medicinal ingredients.
- Shingrix (varicella zoster virus glycoprotein E) was rejected as the patent did not include an eligible claim; rather, it included formulation claims to the antigen and adjuvant. GlaxoSmithKline has brought an application for judicial review(5) over this rejection. One of the issues that has been raised is whether both the antigen and adjuvant in Shingrix are medicinal ingredients. The judicial review is scheduled for November 2019.
- Bevespi Aerosphere (glycopyrronium (as bromide)/formoterol fumarate dihydrate) was rejected as the patent did not include an eligible claim; instead, it included claims to a formulation or use of a formulation.
- Juluca (dolutegravir sodium/rilpivirine hydrochloride) was rejected as the patent did not include an eligible claim. Specifically, the claims were directed to one of the medicinal ingredients but not the combination of medicinal ingredients. ViiV Healthcare has brought an application for judicial review(6);
- Oxervate XERVATE (cenegermin) was rejected as the CSP application was filed before the issuance of the NOC.
- Biktarvy (bictegravir sodium/emtricitabine/tenofovir alafenamide hemifumarate) was rejected as the patent claims were directed to one of the medicinal ingredients but not the combination of medicinal ingredients.
- Belsomra ELSOMRA (suvorexant) was rejected as the application referred to a new drug submission (NDS) which did not lead to an NOC. The application referenced a date for an NOC granted for a different NDS but that NDS was not submitted within the prescribed period following marketing approval in the United States. Further, the application was not filed within the prescribed period following the grant of the patent. Merck has brought an application for judicial review.(7)
Useful reminders include the following:
- CSPs are granted by Health Canada, not the Canadian Intellectual Property Office (CIPO), and the CIPO records include no copy of or reference to the CSP (unless a person chooses to file it).
- CSPs are listed on the CSP register.
- CSPs are automatically added to the patent register and are searchable therein.
- According to the service standard, Health Canada will issue the CSP or advise that it has been preliminarily refused with an opportunity to provide representations within an average of 60 days, starting when no conflicting application of the highest priority and the time for filing an application having the same or higher priority has ended.
- CSPs have no maintenance fees.
Among other tips, it is important to consider the possibility of a CSP early in the drug development and approval lifecycle. In addition, when choosing the patent, consideration should be given to the related regimes, including:
- the term relative to data protection (which will expire eight years after the first NOC or eight-and-a-half years with paediatric extension);
- that if the patent is listed against the regulatory submission and the submission relates to a drug for which the CSP grants rights, the CSP will be listed; and
- that once the relevant provisions of the Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act are in force, CSPs will be subject to the Patented Medicine Prices Review Board's jurisdiction.
The following factors must also be considered:
- the relative strength of patents;
- the likelihood of infringement;
- the likelihood of a CSP grant; and
- the timing for patent grant.
In particular, when assessing the timing for patent grant, the following priority considerations must also be factored in:
- Coordination among regulatory, patent and marketing teams is crucial.
- The earliest CSP deadline should be taken note of, as the Canadian regulatory submission must be filed within one year of the first application for marketing approval of the medicinal ingredient or combination being filed in the United States, European Union (or any member country thereof), Japan, Switzerland or Australia.
- Given the priority rules and the ability of a third party to file for a CSP, it should be of the highest priority category to have patents granted on or before the NOC issues.
- A patent for a new medical use can be granted a CSP, even if the first submission is not indicated for that use.
- Confirm that the CSP register and patent register are updated on grant of the CSP.(8)
(1) For further details on the first anniversary of the CSP regime, please see "Certificate of supplementary protection regime: first anniversary update", which provides a brief overview of:
- what a CSP is;
- how to obtain a CSP;
- approvals, rejections and pending applications;
- the regime in context; and
- relevant resources.
(2) Given the similarities to the European supplementary protection certificates (SPCs), a chart comparing CSPs to SPCs is available here.
(3) Health Canada's statistical report is available here.
(4) Health Canada's guidance document is available here.
- Text of the Comprehensive Economic and Trade Agreement Article 20.27: Sui generis protection for pharmaceuticals;
- Sections 104 to 134 of the Patent Act: Supplementary Protection for Inventions – Medicinal Ingredients (per Section 59 of the Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act;
- Certificate of Supplementary Protection Regulations (the version with the Regulatory Impact Analysis Statement is available here);
- Register of Certificates of Supplementary Protection and Applications (the links to application forms and payment details are available here and here); and
- Health Canada guidance.
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