Canada: Proposed Amendments To The PM(NOC) Regulations: Patents Claiming Different Salt Forms Of Medicinal Ingredients Eligible For Inclusion On The Patent Register

On April 23, 2021, Proposed PM(NOC) Amendments ¹ were published in the Canada Gazette, Part I. These amendments permit patents claiming different forms of a medicinal ingredient (e.g., salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments ² published on March 30, 2019 which allow generic manufacturers to file an ANDS for an alternative form of a medicinal ingredient in comparison to the CRP.

Proposed FDR Amendments Create Imbalance in Linkage Regime

As previously reported, the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission ("ANDS") pathway for generic drug products that contain different forms (e.g., different salt forms) of the medicinal ingredient in comparison to the Canadian Reference Product ("CRP").

The Proposed FDR Amendments provide that, under the ANDS pathway, a generic drug product would no longer be required to contain the "identical medicinal ingredient" to the CRP, but rather an "identical therapeutically active component". The "therapeutically active component" is defined as the medicinal ingredient, excluding those appended portions, if any, that cause the medicinal ingredient to be a salt, hydrate or solvate.

The Proposed FDR Amendments create an imbalance by allowing generic manufacturers to file an ANDS for an alternative form of the medicinal ingredient but not permitting patents that claim that different form to be listed on the patent register.

Proposed PM(NOC) Amendments Restore Balance by Expanding PM(NOC) Regulation Protections

The Proposed PM(NOC) Amendments address this imbalance by allowing patents claiming different salt forms of medicinal ingredients to be eligible for inclusion on the patent register. This change is achieved by expanding the definition of "claim for the medicinal ingredient" in the PM(NOC) Regulations as follows (additions underlined):

claim for the medicinal ingredient includes a claim in the patent for the medicinal ingredient, whether chemical or biological in nature, when prepared or produced by the methods or processes of manufacture particularly described and claimed in the patent, or by their obvious chemical equivalents, and also includes a claim for different polymorphs of the medicinal ingredient and a claim for a variation of the medicinal ingredient that, when compared to the medicinal ingredient, is identical, excluding those appended portions, if any, that cause either the variation or the medicinal ingredient to be a salt, hydrate or solvate, but does not include other chemical forms of the medicinal ingredient; (revendication de l'ingrédient médicinal).

The expanded definition covers:

(i) a claim for a salt form that is different from the approved medicinal ingredient (where the approved medicinal ingredient is a different salt form or is a base form); and

(ii) a claim for the base form of the medicinal ingredient (where the approved medicinal ingredient is a salt form).

Transition Provisions to Permit Listing of Previously Ineligible Patents

Given that patents claiming different salt forms of medicinal ingredients were previously ineligible for listing on the patent register, the Proposed PM(NOC) Amendments include a transitional provision that permits a first person to submit or resubmit, within 30 days after the day on which the amendments come into force, a patent on a patent list that meets the eligibility criteria prescribed in the transitional provision, namely:

(a) the patent was ineligible to be added to the register during the period beginning on June 17, 2006 and ending on the day on which these Regulations come into force only because the patent contained a claim relating to a variation of the medicinal ingredient approved through the issuance of a notice of compliance in respect of a new drug submission or a supplement to a new drug submission that, when compared to the medicinal ingredient, is identical, excluding those appended portions, if any, that cause either the variation or the medicinal ingredient to be a salt; and

(b) the patent was issued in relation to a patent application with a filing date in Canada that precedes the filing date of the submission or supplement.

Interested persons have 30 days to make representations concerning the Proposed PM(NOC) Amendments.

Footnotes

1. Regulations Amending the Patented Medicines (Notice of Compliance) Regulations ("Proposed PM(NOC) Amendments")

2. Regulations Amending the Food and Drug Regulations (Improving Access to Generics ("Proposed FDR Amendments")

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