Proposed Amendments to the Definition of a ‘Claim for Medicinal Ingredient’ Under the Patented Medicines (Notice of Compliance) Regulations

On April 24, 2021, the proposed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations (the proposed Amendments) were published in Canada Gazette, Part I that intend on expanding the definition of ‘claim for medicinal ingredient’ under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). This change would permit patents containing a claim related to a different salt form of an approved medicinal ingredient to be eligible for listing on Canada’s patent register.

The proposed Amendments follow the 2019 proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (the FDR amendments; previously reported by the E-TIPS® Newsletter here) that seek to improve access to generic medicines in Canada under the Abbreviated New Drug Submission pathway. The expanded definition of ‘claim for medicinal ingredient’, which is informed by the definition of ‘therapeutically active component’ in the FDR amendments, covers:

1. 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
2. a claim for the base form of the medicinal ingredient (where the approved medicinal ingredient is a salt form).

The proposed Amendments include a transitional provision allowing a first person (i.e. an innovative drug manufacturer) to submit or resubmit, within 30 days after the proposed Amendments are enacted, a patent containing a claim for medicinal ingredients for inclusion on the patent register that meets the prescribed eligibility criteria. Accordingly, the proposed Amendments are intended to come into force before the FDR amendments such that the first person can update patent lists for eligible patents.

Interested persons are invited to make submissions until May 24, 2021 concerning the proposed Amendments.

Summary By: Anna Troshchynsky