Update: Health Canada’s “Forward Regulatory Plan: 2023-2025” no longer lists the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug Regulations (Improving Access to Generic Drugs)” (our previous article). We have been advised that the proposed amendments, as well as the below proposed amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations Amending the Patented Medicines (Notice of Compliance) Regulations), are on hold.
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.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.