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 Patent Register.
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 industry stakeholders.
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 Regulations.9
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 Canada.
1 SOR/93-133 [Regulations]; Notice (Regulations Amending the (Patented Medicines) Notice of Compliance Regulations), (2015) C Gaz 1, 97-913. [Proposed Amendments] http://www.gazette.gc.ca/rp-pr/p1/2015/2015-05-02/pdf/g1-14918.pdf
2 See Proposed Amendments, s. 2 and 4(2.1)
3 Viiv Healthcare ULC v. Teva Canada Limited, 2014 FC 893 [Viiv]; appeal dismissed 2015 FCA 93
4 See Proposed Amendments, s. 3.2 and 5
5 See Proposed Amendments, s. 4(2.1)(a)
6 See Proposed Amendments, s. 4(2.1)(d)
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 (2)
9 See Proposed Amendments, s. 5
10 Gilead v Canada (Health), 2012 FCA 254; see also the Regulatory Impact Analysis Statement at page 907-8