Amended PM(NOC) Regulations Now In Force — 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

Scheduled date of publication (Canada Gazette, Part II): July 1, 2015

Summary

Previously announced amendments to the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) were registered and brought into force on June 19, 2015 (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

Purpose of the Amendments

According to the Privy Council Office's précis of the Amendments, the Amendments are intended to:2

"(1) restore the intent of the original and amended [PM(NOC) Regulations], and clarify ambiguities regarding the listing requirements as they relate to patents containing a claim for the medicinal ingredient and combination drugs; (2) confirm the eligibility requirements as they relate to patents containing a claim for the formulation while clarifying the requirements with respect to non-medicinal ingredients specified in the claim; and (3) seek to clarify the eligibility requirements in respect of patents containing a claim for the use of the medicinal ingredient, alone or in combination with other...