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
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 medicinal ingredients, in order to ensure a consistent approach to eligibility under section 4.”
Key features of the Amendments
The Amendments are substantially identical to the version pre-published in the Canada Gazette, Part I, on May 2, 2015. They are expected to be officially published with an accompanying Regulatory Impact Analysis Statement, which has yet to be released, in Canada Gazette, Part II, on July 1, 2015. 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 (iii) the use that is included in the submission requires the use of the medicinal ingredient in combination with another drug.
3. New provisions impacting formulation claims
A new definition of “claim for the formulation” has been introduced. The Amendments state that a “claim for the formulation” need not specify the non-medicinal ingredients contained in the submission in order to be eligible for listing on the Patent Register. If the claim does specify non-medicinal ingredients, however, those non-medicinal ingredients must be contained in the submission.
4. Transitional provision
The court shall apply the PM(NOC) Regulations, as amended, in any ongoing subsection 6(1) application or paragraph 6(5)(a) motion initiated between the prepublication date of the Amendments (May 2, 2015) and the date upon which the Amendments came into force (June 19, 2015).
Jurisprudential background: Gilead and ViiV
Since 2006, paragraph 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 paragraph 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 paragraph 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.