On April 23, 2021, Proposed PM(NOC) Amendments [1] were published in the Canada Gazette, Part I. These amendments permit patents claiming different forms of a medicinal ingredient (e.g., salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers to file an ANDS for an alternative form of a medicinal ingredient in comparison to the CRP.

Proposed FDR Amendments Create Imbalance in Linkage Regime

As previously reported, the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug … Continue Reading