On May 2, 2015, the Governor in Council issued proposed
amendments to sections 2, 3, and 4 of the Patented Medicines
(Notice of Compliance) Regulations.1 These
amendments specifically address the eligibility of listing patent
claims that may not include all medicinal ingredients referred to
in the approved drug product for which listing was sought on the
The amendments make changes to the listing requirements for
three of the four categories of patent claims that are eligible for
listing in subsection 4(2) of the Regulations, namely
medicinal ingredient, use, and formulation
claims.2 The amendments also directly address
patent listing decisions made by the Minister of Health in response
to the Federal Court's decision in
Viiv,3 and apply to ongoing matters
presently before the Courts.4
Below is an overview of the proposed amendments and the issues
relating to the application of those amendments for pharmaceutical
For medicinal ingredient claims, changes to paragraph 4(2)(a)
would allow patents claiming one or more medicinal ingredients to
be listed where the drug submission includes additional medicinal
ingredients to those claimed.5
Similarly for use claims, paragraph 4(2)(d) would allow patents
claiming the use of one or more medicinal ingredients to be listed
against drug submissions that include additional medicinal
ingredients, as well as additional uses, or uses of the medicinal
ingredient in combination with other drugs.6
For formulation claims, changes to paragraph 4(2)(b), along with
changes to the definition for formulation claim in section 2
enumerate different criteria for listing. Changes to paragraph
4(2)(b) will allow patents with formulation claims to be listed
where the drug submission names additional non-medicinal
ingredients not in the patent. Further, under the new definition a
formulation claim need not name all non-medicinal ingredients in
the approved drug.7
Moreover, where the Minister delisted or refused to list a
patent based on the Federal Court decision in Viiv, patent
holders will have 30 days following the coming into force of the
amendments to resubmit their patent to the Minister for addition to
the register.8 Further the proposed amendments
would also apply to motions before the Court that patents are not
eligible for inclusion on the register, as well as ongoing
applications started under the
Issues for Pharmaceutical Industry Stakeholders
These amendments introduce a number of positive changes for
patent holders that reference innovative drugs. In
particular, the amendments match the policy and intent to balance
the early working exception with protection of patent rights
previously applied by the Minister to patent listing decisions
under the Regulations prior to the Courts' decisions
in Viiv and Gilead.10
Implementation of the proposed amendments should also clarify
eligibility of listing patents against drugs with multiple
medicinal ingredients. The opportunity for patent holders to seek
reconsideration of Health Canada's listing and delisting
decisions made on the basis of Viiv, means that many
patents claiming one or more medicinal ingredients could be
eligible for listing.
However, these proposed amendments do not address all listing
issues for patents related to new innovative drugs for which
marketing approval is presently sought. Thus patent listing
decisions will still be made on a case by case basis and with
regard to both the patent claims and drug submission.
These amendments do not yet have the force of law. Stakeholders
interested in commenting have until June 1, 2015 to submit their
comments in writing to the Director of Patent Policy at Industry
1 SOR/93-133 [Regulations]; Notice (Regulations
Amending the (Patented Medicines) Notice of Compliance
Regulations), (2015) C Gaz 1, 97-913. [Proposed
2 See Proposed Amendments, s. 2 and
3 Viiv Healthcare ULC v. Teva Canada
Limited, 2014 FC 893 [Viiv]; appeal dismissed 2015
4 See Proposed Amendments, s. 3.2 and
5 See Proposed Amendments, s.
6 See Proposed Amendments, s.
7 See Proposed Amendments, s. 2(1) and (2)
and 4(2.1)(d), and also the accompanying Regulatory Impact Analysis
Statement at page 909.
8 See Proposed Amendments, s. 3.2(1) and
9 See Proposed Amendments, s. 5
10 Gilead v Canada (Health), 2012 FCA 254;
see also the Regulatory Impact Analysis Statement at page
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