Proposed amendments to the Patented Medicines (Notice of Compliance) Regulations have been published for consultation in the Canada Gazette to expand the definition of a “claim for medicinial ingredient” to include salts so that “the scope of protection under the Regulations corresponds to the type of activities contemplated under the proposed amendments to the [Food and Drug Regulations]”.

The proposed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations would include a transition provision to allow updated patent lists to be submitted.

According to the RIAS, the amendments arise due to amendments to the Food and Drug Regulations published in 2019 (see Regulations Amending the Food and Drug Regulations (Improving Access to Generics)):

Among other things, the proposed FDR amendments are intended to clarify the regulatory requirements under the abbreviated new drug submission (ANDS) pathway for generic drug products that contain different forms (e.g. different salt forms) of the medicinal ingredient in comparison to the Canadian reference product or “CRP” (i.e. the previously approved drug product to which the generic product is being compared). Should the different salt form for which approval is sought be patented, the generics 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. This imbalance is contrary to the intended operation of the linkage regime.