Pharma In Brief - Official Publication Of Amended PM(NOC) Regulations Now Available — Patents Claiming Single Medicinal Ingredients Are Eligible For Listing On The Patent Register For Combination Drugs

Amendment: Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, SOR/2015-0169

Date in force: June 19, 2015

Date of publication (Canada Gazette, Part II, Vol. 149, No. 13): July 1, 2015

Summary

The amendments to the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations), as brought into force on June 19, 2015 (the Amendments), have now been officially published with an accompanying Regulatory Impact Analysis Statement in Canada Gazette, Part II, Vol. 149, No. 13.

Key Features of the Amendments

The Amendments confirm the Minister of Health's (Minister) longstanding policy and practice of listing patents claiming a single medicinal ingredient on the Patent Register with respect to combination drug products. The Amendments were precipitated by two recent Federal Court cases (Gilead and ViiV) holding that listing patents claiming single medicinal ingredients on the Patent Register against combination drug products was inconsistent with paragraph 4(2)(a) of the PM(NOC) Regulations.1

We previously reported on the key features of the Amendments prior to today's official publication [ Pharma in brief of June 25]. The key features of the Amendments are the following:

1. 30 day deadline to obtain recourse for patents deleted or denied listing

   The Amendments provide redress for innovators whose patents were deleted from, or refused listing on, the Patent Register from October 18, 2014 to June 19, 2015 on the basis of the ViiV decision. Eligible patent lists may be resubmitted to the Minister in relation to the submission or supplement for addition to the Patent Register within 30 days after June 19, 2015.

2. New interpretational rules impacting combination drugs

   New subsection 4(2.1) introduces rules that apply when determining the eligibility of a patent to be added to the register under paragraphs 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...