Recently proposed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations1 seek to:
- make patents with claims related to a different salt form of an approved medicinal ingredient eligible for inclusion on the Patent Register; and
- provide a transitional provision, to give a first person a period of time to submit or resubmit a patent containing such a claim for inclusion on the Patent Register.
Why?
The Patented Medicines (Notice of Compliance) Regulations (the "Regulations") create a patent linkage regime, which ties regulatory approval of subsequent entry drugs (typically generic or biosimilar drugs) under the Food and Drugs Act and the Food and Drug Regulations ("FDR") to the patent status of the comparator innovative product that the subsequent entry manufacturer seeks to copy.
On March 30, 2019, proposed amendments to the FDR were published.2 These amendments were intended to clarify the regulatory requirements under the abbreviated new drug submission ("ANDS") pathway for generic drug products that contain different forms of the medicinal ingredient in comparison to the Canadian reference product.
The assessment would no longer be whether the generic drug product contains an "identical medicinal ingredient"; rather, ANDS eligibility would be determined by assessing whether there is an "identical therapeutically active component." A "therapeutically active component" is defined as "a medicinal ingredient, excluding those appended portions, if any, that cause the medicinal ingredient to be a salt, hydrate or solvate." Namely, generic drugs that are a salt, hydrate, or solvate of a Canadian reference product will be eligible to be approved through the ANDS pathway.
According to Industry Canada, this proposed amendment would "upset the balance" should the different salt form for which approval is sought be patented, as the generic manufacturer could benefit from the early working exception in developing its ANDS. However, the innovator manufacturer would not be able to benefit from the corresponding protection offered under the Regulations, as the relevant patent could not be added to the Patent Register because claims related to a different chemical form of the medicinal ingredient are currently ineligible.
The amendments
The proposed amendments would expand the definition of "claim for the medicinal ingredient" in section 2 of the Regulations to include "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."
As drafted, this definition, which is informed by the definition of "therapeutically active component" in the proposed FDR amendments, covers:
- 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,
- a claim for the base form of the medicinal ingredient (where the approved medicinal ingredient is a salt form).
The proposed amendments also 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. The 30-day period would provide first persons with sufficient time to make a submission without creating prolonged uncertainty for subsequent entry manufacturers looking for clarity, in advance of filing their submission, on what patents they will be required to address under the Regulations.
Interested persons may make representations concerning the proposed amendments to the Regulations before May 24, 2021.
Footnotes
1 Canada Gazette, Part I, Volume 155, Number 17: Regulations Amending the Patented Medicines (Notice of Compliance) Regulations.
2 Canada Gazette, Part I, Volume 153, Number 13: Regulations Amending the Food and Drug Regulations (Improving Access to Generics).
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