On December 23, 2023, the Federal Court of Appeal (FCA) issued its reasons in Janssen Inc. v Apotex Inc., 2023 FCA 253, allowing an appeal by Janssen Inc. and Janssen Pharmaceutica N.V. (collectively, Janssen) on grounds of abuse of process and granting its motion for summary judgment.
In Janssen Inc. v Apotex Inc., 2023 FC 912, the Federal Court (FC) dismissed Janssen’s motion for summary judgment in four related patent infringement actions (the Underlying Actions) against Apotex Inc. (Apotex), involving Janssen’s Canadian Patent No. 2,655,335 (the Patent) for its paliperidone palmitate suspension (marketed as INVEGA SUSTENNA). Apotex’s Notices of Allegation (NOAs) in the Underlying Actions alleged that the claims of the Patent are invalid and did not otherwise allege non-infringement.
In this action, Janssen relied on the fact that it previously commenced another action against Apotex in response to an earlier NOA in 2021. Apotex’s 2021 NOA alleged that its generic version of INVEGA SUSTENNA would not infringe the Patent; no grounds of invalidity were alleged. The FC disposed of the action, finding that Apotex would induce infringement of the Patent (Janssen Inc. v Apotex Inc., 2022 FC 107).
Accordingly, Janssen argued Apotex’s invalidity allegation in the Underlying Actions was an abuse of process, as any such allegation could have, and should have, been raised in the prior action relating to the 2021 NOA.
The FCA found that the FC erred in law and applied the wrong legal test in determining that there was no abuse of process. Rather, the FC should have considered “whether a defendant in a normal patent infringement action under section 55 of the Patent Act that defends itself on the basis of non-infringement (without challenging the validity of the patent in suit) would, after losing on that defence, be allowed to commence a separate impeachment action concerning the same patent”. The FCA stated that absent special circumstances, such a subsequent action would typically constitute an abuse of process.
Further, as an explicit goal of the 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations was to enable all issues to be addressed in a single action, the FCA held that “the second person should raise all of its allegations in its NOA” and not “keep some in reserve in the event that it is not initially successful”.
Ultimately, the FCA declared Apotex’s defences in the Underlying Actions to be an abuse of process, allowed Janssen’s appeal, set aside the FC’s judgment, and granted Janssen the relief sought.
Summary By: Steffi Tran
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