Proposed amendments to the Patented Medicines (Notice of Compliance) Regulations would expand definition of “claim for the medicinal ingredient”

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On April 24, 2021, proposed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations were published (proposed PMNOC amendments).

The proposed PMNOC amendments relate to the 2019 proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (proposed FDR amendments)(previously reported here), which would allow a generic manufacturer to file an abbreviated new drug submission for a different salt form of the medicinal ingredient in the Canadian reference product. The proposed FDR amendments have not yet been finalized.

The objective of the proposed PMNOC amendments is to make patents with claims related to a different salt form of an approved medicinal ingredient eligible for inclusion on the Patent Register by extending the definition of “claim for the medicinal ingredient” to a claim for certain variations, such as a salt:

Current provision

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, but does not include different chemical forms of the medicinal ingredient; (revendication de l’ingrédient médicinal)

Proposed amendment

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)

A transitional provision would allow the first person to submit or resubmit patents on a patent list within 30 days after the day the amendments come into force if (a) the patent was previously ineligible but would be eligible under the amended definition 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.

The proposed PMNOC amendments would come into force on the same day as the proposed FDR amendments, or if registered after, on the date of registration. Interested persons may submit comments until May 24, 2021.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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