On October 9, 2012, the Federal Court of Appeal issued its
decision in Gilead Sciences Canada Inc. v. Canada (Minister of
Health), which has further limited the eligibility for listing
a patent on the Patent Register maintained by the Minister of
Health pursuant to the Patented Medicines (Notice of
Compliance) Regulations (the
This decision arose from an appeal by Gilead Sciences Canada
Inc. ("Gilead") from a judgment of Justice Mosley of the
Federal Court dated January 3, 2012 (Gilead Sciences Canada,
Inc. v. Canada (Minister of Health), 2012 FC 2). Justice
Mosley had dismissed Gilead's application for judicial review
of the Minister of Health's refusal to list Canadian Patent No.
2,512,475 (the "'475 Patent") on the Patent Register
in respect of Gilead's New Drug Submission for the drug
COMPLERA®, which is now approved in Canada for the treatment of
COMPLERA® is a combination drug that includes three active
pharmaceutical ingredients: tenofovir disoproxil fumarate,
emtricitabine and rilpivirine. The patent at issue had both
combination and formulation claims to the combination of tenofovir
disoproxil fumarate, emtricitabine and a third antiviral
agent. The claims further specified that the third antiviral
agent could be a non-nucleoside reverse transcriptase inhibitor
(NNRTI). It was undisputed that rilpivirine is an NNRTI.
Both the Minister of Health and Justice Mosley had considered
whether the '475 Patent was eligible for listing under
paragraph 4(2)(b) of the Regulations, which
relates to claims to formulations. The Federal Court of
Appeal held that this was an error, as section 2 of the
Regulations specifically defines a "claim for the
formulation" as a claim to a mixture of both medicinal and
non-medicinal ingredients. Since the '475 Patent
contained claims which did not refer to non-medicinal ingredients,
the Court of Appeal held that the relevant provision was paragraph
4(2)(a), which relates to claims for the medicinal
This finding could have been a significant victory for Gilead
based on a prior Federal Court decision indicating that the
"product specificity" requirement under section
4(2)(a) was not as strict as the requirement under
paragraphs 4(2)(b) or 4(2)(c) (which relates to
claims for a dosage form). Specifically, in Bayer Inc. v.
Canada (Health) (2009 FC 1171), the Court noted that Health
Canada's Guidance Document for the Regulations stated
that a claim that refers to only one medicinal ingredient may be
listed against an approved product containing more than one
medicinal ingredient. Under this interpretation, the '475
Patent should have been eligible for listing against COMPLERA®,
despite not specifically naming rilpivirine in the claims.
However, the Court of Appeal rejected the suggestion that the
different paragraphs of subsection 4(2) should be subject to
different interpretations in terms of product specificity.
Thus, the strict product specificity requirements imposed since
2006 by the Courts and the Minister for formulation and dosage
forms claims also applied for claims for a medicinal
The Gilead decision represents an extreme example of
the strict specificity requirement that has been judicially-imposed
since the 2006 amendments to the Regulations, even though
this is not required by the amended Regulations.
This stringent specificity requirement means that a patentee who
does not specifically identify in the patent claims the medicinal
ingredients within a drug by name or by chemical structure will not
be allowed to list a patent in respect of that drug, even though
the medicinal ingredient may be generally encompassed within the
scope of the claims. Consequently, a generic company who would
necessarily infringe the patent will be permitted to come to market
with a generic version of the innovative drug without addressing
the patent under the Regulations. This scenario
defeats the purpose of the Patented Medicines (Notice of
Compliance) Regulations, which is to prevent generic companies
from abusing the "early working exception" in section
55.2(1) of the Patent Act by marketing their product
during the term of an innovator's patent.
In light of this decision, and barring a favourable Supreme
Court of Canada decision or an amendment to the
Regulations, innovators will have to keep product
specificity in mind when drafting their patents and, if possible,
consider amending the claims to reflect their product prior to the
patent being issued.
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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