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.
