Court Rules a Patent Claim to an Adjuvant and Vaccine May be Eligible for a Certificate of Supplementary Protection

Certificates of supplementary protection (CSPs) were part of a regime introduced with the Canada-European Union Comprehensive Economic Trade Agreement (CETA). A CSP allows for a 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. A patent is eligible for a CSP if it:

1. is in force at the time of the application for a CSP, and at the time of CSP grant;
2. has at least 2 years remaining in its patent term;
3. pertains to one medicinal ingredient or a combination of medicinal ingredients; and
4. includes at least one claim directed at:
   1. the medicinal ingredient;
   2. any use of the medicinal ingredient or a combination of all medicinal ingredients; or
   3. the medicinal ingredient as produced by a defined process.

In the case GlaxoSmithKline Biologicals S.A. v The Minister of Health, 2020 FC 397, Canada’s Federal Court considered the eligibility requirement that the patent pertain to “one medicinal ingredient or a combination of medicinal ingredients”. This decision was directed towards the patent for the vaccine SHINGRIX^®, which claims an antigen in combination with an adjuvant. The Minister decided that the patent was not eligible for a CSP because every claim in the patent included an adjuvant, which, in the Minister’s view, was not a medicinal ingredient because it did not independently initiate an immunological reaction. This determination was made despite undisputed evidence that an adjuvant was essential to the vaccine’s clinical efficacy.