Certificate of Supplementary Protection Regime: Second Anniversary Update

September 21, 2019 marked the second anniversary of the certificate of supplementary protection (CSP) regime in Canada. CSPs provide an additional term of patent-like protection of up to two years. In our first anniversary update (see article here), we provided a brief primer on (i) what a CSP is, (ii) how to obtain a CSP, (iii) a summary of approvals, rejections, and pending applications, (iv) a description of the regime in context, and (v) relevant resources. Given the similarities to European Supplementary Protection Certificates, we also provided a comparison chart between CSPs and SPCs.

With our second anniversary update, we provide (i) an updated summary of approvals, rejections, and pending applications and (ii) further reminders and tips.

Approvals, Rejections, Applications in Progress

As of September 21, 2019, Health Canada had granted thirty-one (eighteen in the second year) CSPs for drugs for human use and two for veterinary use; three applications were pending. Twenty-eight of the issued CSPs have the maximum two-year term. Health Canada’s statistical report for CSPs, etc. provides statistics as well, but covering the fiscal year ending March 31, 2019.

Health Canada has rejected eight applications to date on the following bases (see also Health Canada’s statistical report):

• REBINYN (coagulation factor IX (recombinant), pegylated), 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 notice of compliance (NOC) issued before September 21, 2017, and the patent claims specify only one medicinal ingredient (see Guidance document revision below) whereas the drug at issue includes a combination of medicinal ingredients.
• SHINGRIX (varicella zoster virus glycoprotein E), as the patent did not include an eligible claim: it included formulation claims to the antigen and adjuvant. GlaxoSmithKline has brought an application for judicial review (T-1603-18) of the rejection of the SHINGRIX application. One of the issues raised is whether both the antigen and adjuvant in SHINGRIX are medicinal ingredients. The judicial review is scheduled to be heard in November 2019.
• BEVESPI AEROSPHERE (glycopyrronium (as bromide) / formoterol fumarate dihydrate), as the patent did not include an eligible claim: it included claims to a formulation or use of a formulation.
• JULUCA (dolutegravir sodium / rilpivirine hydrochloride), as the patent did not include an eligible claim: 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 (T-353-19).
• OXERVATE (cenegermin), as the CSP application was filed prior to the issuance of the NOC.
• BIKTARVY (bictegravir sodium / emtricitabine / tenofovir alafenamide hemifumarate), as the patent claims were directed to one of the medicinal ingredients but not the combination of medicinal ingredients.
• BELSOMRA (suvorexant), as the CSP application (i) referred to a New Drug Submission (NDS) which did not result in a NOC and (ii) referred to a NOC date for a different (subsequently filed) NDS that was not filed within the prescribed time of the US NDA filing*. Merck has brought an application for judicial review (T-1471-19).

Further reminders/tips

REMINDERS:

• CSPs are granted by Health Canada, not the Canadian Intellectual Property Office (CIPO), and the CIPO records do not include a copy of or reference to the CSP (unless a person chooses to file the CSP);
• CSPs are listed on the CSP Register;
• CSPs are automatically added to the Patent Register and are searchable within the Patent Register;
• 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; and
• There are no maintenance fees for CSPs.

TIPS:

• Consider the possibility of a CSP early in the drug development and approval life cycle;
• In choosing the patent, consider:

- related regimes, including:

- Term relative to data protection (which will expire 8 years after first NOC, 8.5 years with pediatric extension),

- 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,

- Once the relevant provisions of the CETA Implementation Act are in force, CSPs will be subject to Patented Medicine Prices Review Board (PMPRB) jurisdiction,

- relative strength of patents,

- likelihood of infringement,

- likelihood of CSP grant, and

- timing for patent grant (see priority consideration below);

• Co-ordinate amongst regulatory, patent, and marketing teams;
• Take particular note of the earliest CSP deadline: once the first application for marketing approval of the medicinal ingredient or combination is filed in the U.S., European Union (or any member country thereof), Japan, Switzerland or Australia, the Canadian regulatory submission must be filed within one year; 
• Given the priority rules and the ability of a third party to file for a CSP, attempt to have patents granted on or before the NOC issues = highest priority category;
• A patent for a new medical use can be granted a CSP, even if the first submission is not indicated for that use; and
• Confirm that the CSP Register and Patent Register are updated upon CSP grant.

Relevant resources

• Text of the Comprehensive Economic and Trade Agreement Article 20.27: Sui generis protection for pharmaceuticals
• Patent Act  sections 104-134: Supplementary Protection for Inventions — Medicinal Ingredients (per Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act, section 59)
• Certificate of Supplementary Protection Regulations (version with Regulatory Impact Analysis Statement is  here)
• Register of Certificates of Supplementary Protection and Applications (with links to application forms and payment details)
• Health Canada Guidance