The Patented Medicines (Notice of Compliance) Regulations
| Author | T. Nessim Abu-Zahra/Simon Carvalho/David Edwards |
| Pages | 195-243 |
FOURTEEN
The Patented Medicines
(Notice of Compliance) Regulations
A. OVERVIEW
As explained in Chapter , a person may obtain separate patents in relation
to a wide variety of inventions related to aspects of a particular drug, such
as its active ingredient, dosage form (such as a controlled release tablet or
transdermal patch), and its therapeutic use. Further, like any other patent,
these patents may be enforced by way of an action for infringement under
section of the Patent Act and can be declared invalid by way of an action
for impeachment under section of that act.
Some of the patents that relate to a drug may also be eligible for pro-
tection under the Patented Medicines (Notice of Compliance) Regulations
(PM(NOC) Regulations), which create a patent linkage regime that ties: ()
regulatory approval of “generic” or “biosimilar” drugs (i.e., drugs for which
a person seeks regulatory approval on the basis of a comparison with, or
reference to, a drug already approved by the Minister of Health) to () the
protection of patent rights of the drug being copied. e PM(NOC) Regu-
lations set up an intricate scheme that, broadly, has the eect of preventing
the Minister of Health from granting regulatory approval of a generic or
biosimilar drug for a period of time while patent issues are being dealt with,
thereby creating a linkage between the approval of the generic/biosimilar
drug and the enforcement of patent rights that protect the drug being copied.
RSC , c P- [Patent Act].
SOR/-, as amended [PM(NOC) Regulations].
The Regulation of Drugs in Canada
is chapter will describe the functioning of the PM(NOC) Regulations,
with an emphasis on the Minister’s role in administering the scheme and
how it aects the Minister of Health’s ability to issue a notice of compliance
(NOC) under the Food and Drug Regulations (FDRs).
B. BACKGROUND
1) Section 55.2 of the Patent Act
e PM(NOC) Regulations came into force in , as part of wide-ranging
changes in Canadian patent law and pharmaceutical policy. One of these
changes was the enactment, in , of section . of the Patent Act. In
particular, section .() created the so-called early-working exception to
patent infringement, which in eect permits a drug company to take action
to prepare submissions for regulatory approval which would otherwise con-
stitute patent infringement. Section .() provides as follows:
. () It is not an infringement of a patent for any person to make, con-
struct, use or sell the patented invention solely for uses reasonably related
to the development and submission of information required under any law
of Canada, a province or a country other than Canada that regulates the
manufacture, construction, use or sale of any product.
In the absence of the early-working exception, companies wishing to
enter a regulated marketplace would have to either delay activities needed to
obtain regulatory approval for a product, such as making their own version
of the product and testing it, until after a competitor’s patent expired, or
risk being sued for patent infringement. e Government of Canada has
explained how this “early-working” exception relates to the regulation of
drugs as follows:
In the pharmaceutical industry, early-working allows second and subse-
quent entry drug manufacturers (typically generic drug companies) to
use a patented, innovative drug for the purposes of seeking approval to
market a competing version of that drug. Normally, conduct of this kind
would constitute patent infringement but an exception has been made
so that generic drug companies can complete Health Canada’s regulatory
approval process while the equivalent innovative drug is still under patent,
CRC, c .
See Chapter .
The Patented Medicines (Notice of Compliance) Regulations
in order to be in a position to enter the market as soon as possible after
patent expiry.
e amendments also introduced section .() of the Patent
Act. at section permits the Governor in Council to make regulations
“respecting the infringement of any patent that, directly or indirectly, . . .
results from the making, construction, use or sale of a patented invention
in accordance with subsection ().” e PM(NOC) Regulations were made
pursuant to this provision and aim to prevent patent infringement during
the life of the patent by generic/biosimilar manufacturers who take advan-
tage of the early-working exception.
In AstraZeneca Canada Inc v Canada, the Supreme Court of Canada
explained this legislative history as follows:
e problem perceived by Parliament in was that if a generic manu-
facturer waits to begin its preparation of a copy-cat medicine for regulatory
approval until the patent expires, the FDA approval process will likely add
at least two years to the eective monopoly of the patent owner, which
is two years of monopoly longer than the Patent Act contemplates. On
the other hand, if the generic manufacturer tries to work the patented
invention prior to the expiry of the patent, even if solely to satisfy the FDA
requirements for a NOC, it will infringe the patent, thus inviting litigation
by the patent owner (and this is a very litigious industry).
e solution arrived at by Parliament in Bill C- () was to
introduce an exemption from the owner’s patent rights which permits the
generic manufacturers to work the patented invention within the -year
period (the “early working” exception) to the extent necessary to obtain a
NOC eective at the time the patent(s) expire (s. .()) and to “stockpile”
generic product towards the end of the -year period to await lawful
market entry (s. .()). (e “stockpiling” exception was repealed by
S.C. , c. , s. () (in force July , ).)
Recognizing that the “early working” and “stockpiling” exceptions
could be abused, Parliament balanced creation of these exceptions with
implementation of a summary procedure designed to strengthen the
See RIAS accompanying “Regulations Amending the Patented Medicines (Notice
of Compliance) Regulations,” SOR/- ( October ), Canada Gazette II,
Vol, No , at [SOR/-].
AstraZeneca Canada Inc v Canada (Minister of Health), SCC [AstraZeneca v
Canada]; Bristol-Myers Squibb Co v Canada (Attorney General), SCC , []
SCR [Biolyse].
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