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Special Promotional Feature
IP PROTECTION AND
REGULATORY LAW IN
THE LIFE SCIENCES
ONE UNIQUE aspect of obtaining patent
protection for life sciences-related technolo-
gies in Canada is the suite of regulatory and
compliance matters that come into play. ese
regulatory schemes exist largely to balance the
accessibility of life sciences innovations with
intellectual property protection.
Patented Medicines (Notice of
Compliance) Regulations
e PMNOC Regulations establish Canada's
"patent linkage" system. Under this scheme,
the Minister of Health maintains a Patent
Register listing patent(s) related to an
approved small molecule or biologic drug.
e minister is then prohibited from
granting regulatory approval to a manufac-
turer of a drug seeking marketing authoriza-
tion based on a comparison or reference to
the drug that is listed on the Patent Register
unless and until the manufacturer addresses
the listed patent(s).
A patent is eligible to be listed on the Patent
Register only if it includes a claim for a me-
dicinal ingredient, formulation, dosage form
medicinal ingredient, or use of a medicinal in-
gredient for which regulatory approval for sale
in Canada has been granted or will be pending
when the patent issues. To add a patent to the
Patent Register, the applicant must submit a
"patent list" to Health Canada within 30 days
aer issuance of the patent if a related regula-
tory submission has been filed. If such a sub-
mission has not yet been filed when the patent
issues, the patent list must be filed together
with the regulatory submission.
Certificates of Supplementary
Protection (CSPs)
CSPs were introduced in Canada in 2017
to compensate for delays in drug approv-
al before Health Canada. A CSP gives the
holder and their legal representatives rights
granted by the patent set out in the CSP for
up to two years aer expiry of the patent.
CSPs are available for both small molecules
and biologics. ese rights are not extended
to making, constructing, using, or selling for
the purposes of exporting.
To be eligible for a CSP, a patent must claim
a medicinal ingredient (MI), combination of
MIs, or a use of an MI or combination thereof
contained in a drug for which marketing au-
thorization has been granted by way of a No-
tice of Compliance (NOC) issued by Health
Canada. e MI or combination thereof must
not have been previously approved and there
must not have been a prior CSP granted for
the MI or combination thereof. Further, MIs
that differ from each other with respect to a
prescribed variation will be treated as the same
MI. e Federal Court has also considered the
CSP Regulations and provided further guid-
ance on eligibility (see articles on Bereskin &
Parr's website: "Federal Court finds Minister
of Health's refusal of BELSOMRA CSP un-
reasonable, remits for redetermination" and
"Federal Court of Appeal Affirms Minister's
Decision that CSP Eligibility Requires Claim
for Active Ingredients and Excludes Formula-
tions Claims").
Deadlines for filing CSPs must be mon-
itored carefully. e new drug submission
(NDS) on which the NOC issued must have
been filed in Canada within 12 months aer
first related regulatory filing in the EU or
any country thereof, the US, UK, Australia,
Switzerland, or Japan. Further, the unextend-
ible deadline for filing a CSP application is
the later of 120 days aer the issuance of the
patent or 120 days aer the marketing autho-
rization has issued.
Data protection
Irrespective of whether a patent exists, Canada
provides eight years of data protection under
the Food and Drugs Act for an "innovative
drug" containing a medicinal ingredient
not previously approved by Health Canada.
is data exclusivity period applies to both
small molecules and biologics. Under this
scheme, a manufacturer may not file a drug
submission referencing an innovative drug
within six years of the initial authorization of
the innovator drug, with an additional two-
year period that applies before marketing
authorization can be granted. Where clinical
trials relating to the use of the drug in
pediatric populations have been conducted,
an additional six months of exclusivity may
be added to the eight-year term.
Patented Medicine Prices Review Board
(PMPRB)
e PMPRB is a federal administrative body
created under the Patent Act with the mandate
of ensuring that the price of patented medicines
sold in Canada is not "excessive." e PMPRB
reviews prices of patented medicines sold in
Canada based on comparison to prices in other
markets. If a price is found to be excessive, the
board can impose remedies including ordering
a reduction in the price of the medicine and/or
payment to Canada of a specified sum.
e scope of the PMPRB's jurisdiction has
been at issue of late, both before the courts
and with proposed amendments to the Pat-
ented Medicines Regulations (see articles on
Bereskin & Parr's website: "Supreme Court of
Canada Takes a Pass on Patented Drug Price
Dispute"; "Canada Drops its Most Contro-
versial Patented Drug Pricing Amendments";
and "Proposed Canadian Drug Pricing Rules
Delayed by Feds and Battered by Courts").
However, the government of Canada recent-
ly dropped some of their more contentious
proposed amendments, confirming that for
the time being the PMPRB's jurisdiction will
remain limited to the control of excessive pric-
es resulting from patent monopoly. e list of
countries that the PMPRB uses for compari-
son will be updated, including the removal of
the United States and Switzerland.
Melanie Szweras
and Ainslie Parsons
Bereskin & Parr LLP
