Second Person Not Strictly Bound by NOA

Sunovion Pharmaceuticals Canada Inc v Taro Pharmaceuticals Inc 2021 FCA 113 Locke JA: de Montigny, Rivoalen JJA affg 2021 FC 37 Furlanetto J

2,538,265 / 2,696,510 / 2,814,828 / lurasidone hydrochloride

In this decision the FCA has held that under the new NOC Regs a second person is not strictly limited to the infringement and invalidity allegations set out in its NOA, as was the case in the old proceedings. This holding was based in large part on an express statement in the RIAS accompanying the amendments that the requirement to set out the legal and factual allegations in the NOA “does not circumscribe or otherwise limit the issues and arguments that may be raised in a proceeding brought under the Regulations” [5].

Locke JA acknowledged the concern that this might make it difficult for a patentee to assess its risk when deciding whether to respond and might also lead to case splitting. The FCA agreed with Furlanetto J that there are two checks on this problem. First, the discretion afforded under s 8(6) of the Regs, permits the Court to consider whether the first person was improperly influenced to start an action because of an incomplete NOA as a factor in assessing s 8 compensation: [7]. The second check is the Court’s discretion to grant or dismiss a motion to amend a pleading. “If a Court is convinced that a proposed amendment seeks to introduce invalidity allegations of which the moving party was aware when its NOA was served, the Court may dismiss the motion on the basis that permitting the amendment would not serve the interests of justice” [8].