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...