The Federal Court found it was inappropriate to vary the Protective and Confidentiality Order in the original action brought by Janssen against Apotex with respect to paliperidone and Canadian Patent No. 2,655,335 to allow Janssen to use confidential documents from the Original Action in four subsequent actions against Apotex. Nevertheless, the Court endorsed the parties’ agreement to certain variances to the Confidentiality Order.
Although the Notice of Allegation for the Original Action only alleged non-infringement (and did not allege invalidity), Apotex’s NOAs for the New Actions alleged that the 335 Patent was invalid for being an unpatentable method of medical treatment.
Janssen brought a motion seeking to vary the Confidentiality Order to permit it to use in the New Actions documents from Apotex’s motion for summary trial at the end of 2021 and its appeal from that motion.
The Court held Janssen’s motion was procedurally defective and premature, as it was brought before Janssen sought relief from the implied undertaking. The implied undertaking applies to information compelled during pre-trial discovery, which can only be used by the parties for the purpose of the litigation in which it was obtained (Juman v Doucette, 2008 SCC 8 at para 1).
While the documents Janssen sought to use had been tendered in the Original Action, they had been entered into the court record as confidential, and the proceedings involving the confidential documents were held in camera. The implied undertaking is only “spent” when documents are tendered in open court at trial (Fibrogen, Inc v Akebia Therapeutics Inc, 2022 FCA 135 at para 60).
The Court also held Janssen’s motion was overly broad. Janssen intended to use the documents to show that “Apotex defended the [Original Action] only on the basis of non-infringement and that it was not defending the [Original Action] on the basis of patent invalidity.” However, this fact was disclosed in the Public Reasons for Judgment for the summary trial.
With respect to a redacted fact that Janssen sought to prove in the New Actions, the parties agreed that Janssen could use select evidence from the Original Action to support its argument. Besides endorsing Apotex’s concession, the Court also found “no compelling reason for Janssen to require any and all confidential information disclosed over the course of the [Original Action]” for use in the New Actions.
A copy of the decision can be found here.