Generic Allowed To Plead New Grounds Of Invalidity Not Raised In The Notice Of Allegation
Published date | 07 July 2021 |
Subject Matter | Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Biotechnology & Nanotechnology |
Law Firm | Norton Rose Fulbright Canada LLP |
Author | Ms Morgan Westgate and Brian R. Daley |
The Federal Court of Appeal (FCA) has confirmed that in an infringement action under the Patented Medicines (Notice of Compliance) Regulations, the "second person" (i.e., generic/biosimilar) is not precluded from pleading invalidity allegations in its Statement of Defence beyond those that were raised in its notice of allegation (NOA). While new allegations may not be appropriate in every case, nor without consequence for the second person in a subsequent section 8 claim, they are not categorically prohibited.
Background
The underlying Federal Court (FC) decision concerned a motion by a section 6 infringement defendant seeking leave to amend its Statement of Defence. The defendant wished to add allegations of invalidity that were not found in its NOA, but that had been pleaded in the Statement of Defence of another generic in a parallel proceeding. As we reported, the FC allowed the motion.
The Regulations do not limit a defendant to the allegations in the NOA
The FCA upheld the Federal Court's decision allowing the pleading amendments. Notwithstanding that the NOA must include "a detailed statement of any grounds of invalidity", the Regulatory Impact Analysis Statement accompanying the amendments also states that this "does not not circumscribe or otherwise limit the issues and arguments that may be raised in a proceeding brought under the Regulations".
The Court has discretion to remedy unfairness
The plaintiffs argued that allowing the new invalidity allegations was unfair since their decision to risk section 8 liability by commencing the action was based on the generic's NOA.
The FCA rejected this argument, reiterating the FC's finding that the Regulations contain sufficient checks and balances to alleviate any such concern:
- First, subsection 8(6) gives the court discretion to consider factors that could affect the amount of liability under section 8 including whether the "first person" (e.g. brand/patent owner) was improperly influenced to start an action due to an incomplete NOA.
- Second, the court has the discretion to dismiss pleadings amendment motions that are not in the interests of justice, which allows it to deny amendments to introduce allegations that the moving...
To continue reading
Request your trial