PM(NOC) Regulations Do Not Preclude Defendants From Amending The Statement Of Defence

• Published date: 03 February 2021
• Subject Matter: Intellectual Property, Patent
• Law Firm: Norton Rose Fulbright Canada LLP
• Author: Shantelle LaFayette, Christopher Guerreiro and Brian R. Daley

A defendant in a patent infringement action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations was allowed to amend its defence to include invalidity allegations not found in the Notice of Allegation.

Background

In an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations) concerning three patents, the defendant sought to amend its statement of defence to add new prior art references and invalidity allegations. These allegations had been raised against the plaintiffs by a different generic in another subsection 6(1) proceeding, but were not in the defendant's notice of allegation (NOA).

The plaintiffs opposed the motion, arguing that the Regulations restrict the invalidity allegations raised in a statement of defence to those in the NOA. The plaintiffs also argued that allowing generics to raise new invalidity allegations without prior notice would prejudice innovators by hindering their ability to properly evaluate the risks associated with initiating a proceeding.

The Court allowed the proposed amendments.

The proposed amendments are not prohibited by the Regulations

The Court observed that the context of the NOA changed when the Regulations changed in 2017. Under the previous regime, the NOA was the foundation for an application to determine whether all of the allegations found therein were justified. Under the amended Regulations, the proceeding commenced in response to an NOA is an infringement action. The generic then pleads any invalidity allegations in a statement of defence, which may include a counterclaim.

According to the Regulatory Impact Assessment Statement (RIAS) for the amended Regulations, the role of the NOA under this regime is to facilitate early consideration of issues likely to be raised in the litigation. The Court accepted that it is the pleadings'not the NOA'that define the scope of the proceedings, subject to the normal procedural safeguards applicable to pleadings amendments.

The Court also rejected the plaintiffs' argument that the proposed amendments in this case ran contrary to section 6.09 of the Regulations, which obliges the parties to advance the proceedings expeditiously. In the Court's view, the defendant had not willfully withheld the proposed amendments from its NOA.

The defendant was not limited to raising its proposed amendments by counterclaim

The Court also rejected the plaintiffs' argument that the defendant should be limited to...