Industry Canada has announced that the Patent Medicines
(Notice of Compliance) Regulations (PM(NOC) Regulations) will
be amended; according to the federal government's Forward
Regulatory Plan 2015-2017, the changes will "address the
exclusion of certain pharmaceutical patents from Health
Canada's Patent Register following recent Federal Court and
Federal Court of Appeal decisions relating to patents claiming
single medicinal ingredients found in combination
What You Need To Know
If you are currently selling combination drug products in
Canada (or plan on selling these products), Industry Canada's
proposed changes to the PM(NOC) Regulations will impact your
Listing patents that are directed to single medicinal
ingredients on Canada's Orange Book against combination drug
products containing the ingredient is no longer certain.
The outcome of the Federal Court of Appeal decision in ViiV
Healthcare ULC v Teva Canada Limited (ViiV) (see
below) and Industry Canada's proposed changes to the PM(NOC)
Regulations will be highly relevant to listing patents directed to
single medicinal ingredients against combination drug
There will be an opportunity to comment on Industry
Canada's proposed changes to the PM(NOC) Regulations (expected
to be published in Canada Gazette, Part I, in the spring of
The PM(NOC) Regulations link patents to Health Canada's
approval of a generic version of an innovative drug. Patents
associated with an approved innovative drug may be listed on Health
Canada's Patent Register, provided they meet certain listing
requirements contained in the PM(NOC) Regulations. If a
manufacturer compares its generic version to an innovative drug,
the manufacturer must address each patent listed on the Patent
Register with respect to that innovative drug. The manufacturer
must either accept that Health Canada will not issue marketing
approval (in the form of a NOC) until the listed patents have
expired, or must allege that the patent is not valid or no claim
(for the medicinal ingredient, formulation, dosage form or use of
the medicinal ingredient) would be infringed by the drug which is
the subject of the regulatory submission. The manufacturer of the
innovative drug then has an opportunity to apply to a court
prohibiting the Minister of Health from issuing the NOC.
Health Canada's "Guidance Document: Patented Medicines
(Notice of Compliance) Regulations" provides Health
Canada's historical position on listing patents relating to
single medicinal ingredients found in combination drugs on its
Patent Register: "a patent claiming, as a compound, a single
medicinal ingredient will be eligible for listing with
respect to a drug that contains the said medicinal ingredient in
combination with other medicinal ingredients, notwithstanding that
the medicinal ingredient on the NOC is the combination of medicinal
ingredients" (emphasis added).23
The Guidance Document has been recently updated to provide that
two Federal Court decisions have impacted the application of
section 4 of the PM(NOC) Regulations with respect to combination
drugs. These two court decisions are inconsistent with Health
Canada's position as stated in the guidance. In each of
ViiV Healthcare ULC v Teva Canada Limited,
2014 FC 893 and Gilead Sciences Canada v Canada
2012 FCA 254, the Court ruled that in order for a patent to be
listed against a combination drug, the PM(NOC) Regulations require
that the patent claim the exact combination of medicinal
ingredients (i.e., there must be precise and specific matching
between the claim language and the product for which the NOC has
been granted). An appeal of the ViiV decision will be
heard on April 13, 2015.
Industry Canada's proposed amendments will provide
much-needed certainty to drug manufacturers. In the meantime,
Health Canada has begun to refuse to list patents directed to
single medicinal ingredients found in combination drugs on Health
Canada's Patent Register.
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