Certificates of Supplementary Protection
| Author | T. Nessim Abu-Zahra/Simon Carvalho/David Edwards |
| Pages | 265-286 |
SIXTEEN
Certificates of
Supplementary Protection
A. INTRODUCTION
e newest element of Canada’s pharmaceutical intellectual property regime
is the certicate of supplementary protection (CSP), which is a new form of
intellectual property right in the Patent Act that exists only for pharmaceut-
ical products. is regime was brought into force on September as
part of Canada’s broader implementation of the Canada-European Union
Comprehensive Economic and Trade Agreement (CETA), described by the
government as “a progressive free trade agreement which covers virtually
all sectors and aspects of Canada-EU trade in order to eliminate or reduce
barriers.” Among other things, CETA required Canada to provide a form
of sui generis — Latin for “unique” — protection for certain pharmaceutical
products. Accordingly, by way of the Canada-European Union Comprehensive
RSC , c P-.
See Global Aaires Canada, “Canada-European Union Comprehensive Economic and
Trade Agreement (CETA)” (last modied June ), online: Government of Canada
https://international.gc.ca/gac-amc/campaign-campagne/ceta-aecg/index.aspx?lang=eng.
Chapter of CETA is directed to intellectual property more generally and addresses
topics such as trademarks, geographical indications, and patents. Specic to phar-
maceutical products, Chapter of CETA also contains Article ., which relates
to how litigation under the Patented Medicines (Notice of Compliance) Regulations,
SOR/- (discussed in Chapter ) is conducted, and Article ., which relates
to data protection (discussed in Chapter ).
The Regulation of Drugs in Canada
Economic and Trade Agreement Implementation Act, amendments were made
to the Patent Act to create the CSP regime.
B. OVERVIEW
A CSP provides an additional period of up to two years of patent-like pro-
tection for drugs that contain a new medicinal ingredient (or, for drugs
containing multiple medicinal ingredients, a new combination of medicinal
ingredients) and that are protected by an eligible patent. It grants a form of
exclusive rights that are very similar to, but slightly more limited than, the
rights given under a patent. As explained below, a CSP must be applied for
and issued during the life of the underlying patent to which it relates, but
does not take eect until the patent expires. e requirements and process
for obtaining a CSP are quite dierent from those for a patent. However,
the scope of rights granted by a CSP — and court proceedings involving a
CSP — are quite similar to those for a patent. It can therefore be thought of
(albeit somewhat imprecisely) as providing a form of “patent term extension.”
CSPs are issued by the Minister of Health, not the Commissioner of Patents.
e stated purpose of this additional period of protection is to partly
compensate drug manufacturers for the time spent conducting research
and obtaining marketing authorization for eligible patented drugs. e
Federal Court of Appeal in Canada (Health) v Glaxosmithkline Biologicals
SA described the purpose of the scheme as follows:
At the core, it would appear that the goal is to promote research into new
medicinal ingredients or new combinations of medicinal ingredients and
to give an incentive to put them into practice for the benet of the pub-
lic. at incentive is to compensate for part of the time lost in obtaining
approval for that rst drug or pharmaceutical product.
More specically, even if a pharmaceutical product is patented, it must
also successfully complete the process of obtaining regulatory approval under
the Food and Drugs Act (FDA) before it can be sold, and this process will
typically occur after the ling of the patent application and also potentially
SC , c .
“Certicate of Supplementary Protection Regulations, Regulatory Impact Analysis State-
ment,” SOR/- ( September ), Canada Gazette II, Vol , No ,
[CSP Regulations].
FCA at para , rev’g FC [Canada (Health) v Glaxosmithkline].
RSC , c F-.
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