Amendment: Proposed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, Canada Gazette, Part I, Vol. 149, No. 18
Date of pre-publication: Saturday, May 2, 2015
Consultation deadline: Within 30 days after the date of pre-publication (May 2, 2015)
Today, Industry Canada published proposed amendments to the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) to confirm the Minister of Health's (Minister) existing policy and practice of listing patents claiming a single medicinal ingredient on the Patent Register with respect to combination drug products (Proposed Amendments).
The Proposed Amendments were precipitated by two recent Federal Court cases (Gilead and ViiV) holding that the Minister's policy with respect to patents claiming single medicinal ingredients contained in combination drugs was inconsistent with section 4(2)(a) of the PM(NOC) Regulations.1 The Proposed Amendments include redress for innovators whose patents were deleted from, or refused listing on, the Patent Register on or after October 18, 2014 on the basis of the ViiV decision.
For combination drugs, the Proposed Amendments include the following key features:
- New interpretational rules. New
section 4(2.1) introduces rules that apply when determining the
eligibility of a patent to be added to the register under sections
4(2)(a) (claim for the medicinal ingredient) and 4(2)(d) (claim for
the use). In particular:
- a patent that contains a claim for the medicinal ingredient is eligible for listing even if the submission includes, in addition to the medicinal ingredient claimed in the patent, other medicinal ingredients; and
- a patent that contains a claim for the use of the medicinal ingredient is eligible for listing if the submission includes the use claimed in the patent, even if: (i) the submission includes additional medicinal ingredients, (ii) the submission includes other additional uses of the medicinal ingredient, or (iii) the use that is included in the submission requires the use of the medicinal ingredient in combination with another drug.
- Recourse for patents deleted or refused listing on the Patent Register. If the Minister refused to add a patent to the Patent Register, or deleted a patent from the Patent Register on or after October 18, 2014 on the basis of the ViiV decision, the patent list may be resubmitted for listing within 30 days after the day on which the Proposed Amendments come into force.
- Transitional instructions for Courts. The Courts are to apply the PM(NOC) Regulations as amended, in any ongoing section 6(1) application or section 6(5)(a) motion initiated between the publication date of the Proposed Amendments (May 2, 2015) and the date upon which the Proposed Amendments come into force.
In addition, a new definition of "claim for the formulation" has been introduced. The Proposed Amendments state that a "claim for the formulation" need not specify the non-medicinal ingredients or, if some are specified, need not specify all of those contained in the approved product. However, the Proposed Amendments are not intended to modify the existing requirement that an eligible patent list claim for the formulation under section 4(2)(b) must contain all the medicinal ingredients in the approved drug.
Since 2006, section 4(2)(a) of the PM(NOC) Regulations has permitted a claim for the approved medicinal ingredient of a drug to support listing a patent on the Patent Register in respect of that drug. The Minister's established policy and practice applied section 4(2)(a) to support the patent list eligibility of a patent claiming a single medicinal ingredient with respect to a combination drug. The decision in ViiV-FC, relying upon earlier findings of the Federal Court of Appeal in Gilead, disturbed this established interpretation by finding section 4(2)(a) to require that a patent claim all medicinal ingredients contained in the approved combination drug in order to be eligible for listing on the Patent Register with respect to that drug.
As foreshadowed by an earlier published Industry Canada Regulatory Initiative,2 the Proposed Amendments confirm the Minister's established interpretation of listing patents claiming a single medicinal ingredient against combination drugs.
Stakeholders are invited to provide comments on the Proposed Amendments to the PM(NOC) Regulations within 30 days after the date of publication of this notice. Details are available in the Canada Gazette, Part I link provided below.
1 Gilead Sciences Canada Inc v Canada (Minister of Health), 2012 FCA 254 [Gilead], var'g 2012 FC 2 concerning the FDC, COMPLERA®; ViiV Healthcare ULC v Teva Canada Limited, 2015 FCA 93 [ViiV-FCA], aff'g 2014 FC 893 [ViiV-FC], aff'g 2014 FC 328 [collectively, ViiV], concerning the FDC, KIVEXA®.
2 Industry Canada Regulatory Initiative: Amendments to the Patented Medicines (Notice of Compliance) Regulations — Forward Regulatory Plan 2015-2017, as modified 13 February 2015.
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