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ARTICLE · 03 FEBRUARY 2021

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

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...

CanadaIntellectual Property

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

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