Canada is taking steps to improve drug patent owners'
ability to enforce their patents.
Proactive Patent Enforcement - the NOC Regulations
The Canadian Patented Medicine (Notice of Compliance)
Regulations ("NOC Regulations")
allow a patent owner to apply to Federal Court to keep a generic
company's potentially infringing medicine off the market
before the generic company receives
Health Canada approval to sell its medicine. Health Canada is the
Canadian counterpart to the US FDA. The Health Canada approval for
a brand name company or generic company to sell a medicine is
called an NOC. Prior to the NOC Regulations, the patent owner often
had to chase the generic company after
the medicine was already on the market. Since interlocutory
injunctions are difficult to obtain and it takes a long time to
bring a patent infringement case through to trial, there are
significant benefits to a patent owner in keeping a generic company
from entering the market.
The NOC Regulations operate by allowing a patent owner to
request an order prohibiting the government from issuing an NOC to
the generic company. In order to take advantage of the NOC
Regulations, the patent owner must list its patents on a Health
Canada "Patent Register" within strict time limits. If
the patent owner cannot add its patent to the Patent Register, then
there is no trigger for the NOC Regulations, and the patent owner
is back to suing for conventional patent infringement
after the generic company is on the market. Therefore the
issue of whether a particular patent can be listed on the Patent
Register is often hotly contested between brand and generic
Health Canada's practice had been to list patents containing
a claim for an approved medicinal ingredient on the Patent Register
in respect of any approved drug that includes that medicinal
ingredient, even if the patent is for only one drug and
the approved product contains multiple drugs.
A couple of recent court decisions required a patent to claim
all the medicinal ingredients that are in the approved
drug. In Gilead Sciences Canada Inc. v Canada2012 FCA 254, the Federal
Court of Appeal refused listing to a patent that claimed only two
of three medicinal ingredients in the approved drug.
In Viiv et al v. Teva et al,2014 FC 328 and 2014 FC
893. the Federal Court followed the Gilead
case's incorrect example and held that for a patent to be
eligible for addition to the Register, it must specifically claim
all of the medicinal ingredients in the approved drug
containing more than one medicinal ingredient. This decision is
under appeal, but the government has moved forward with its
amendments to avoid delay, since the Federal Court of Appeal is
likely to decide consistent with its earlier decision.
Following these cases, Health Canada refused to list some
patents against drugs with multiple medicinal ingredients. Health
Canada was also under pressure to reconsider the listing of some
patents already on the Register that covered less than all medical
ingredients in a combination drug.
The Solution - Amendments to the NOC Regulations
On May 2, 2015, the federal government issued draft regulations to improve
brand name companies' ability to list patents on the Patent
Register to protect combination drugs. These regulations are in
response to two recent Federal Court decisions that took a narrow
approach to the NOC Regulations. According to Health Canada, the
Courts' narrow approach to listing eligibility requirements
conflicted with the intent the Regulations, necessitating the
amendments. The Canadian brand name companies' association,
called Rx&D, had been actively advocating for these
The new amendments allow relevant product, formulation and use
patents to now be listed against combination drugs. This saves
Health Canada from punting a bunch of patents off the Register.
There is a transition period for previously refused patents to be
reconsidered for listing.
Comments on the new regulations must be filed by June 1,
This position by Health Canada makes good sense. If there is a
clinical benefit to combine a drug with another drug, a company
should be encouraged to make this combination. Reducing patent
protection would discourage such combinations, and patients could
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