Pharma In Brief - Canada Releases Proposed Amendments To The PM(NOC) Regulations - Patents Claiming Single Medicinal Ingredients Are Eligible For Listing On The Patent Register For Combination Drugs

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)

Summary

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.

Highlights

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...