Whose Liability Is It Anyway? The Court Clarifies The Burden In Summary Trials And Infers Inducement

• Published date: 02 February 2022
• Subject Matter: Intellectual Property, Patent
• Law Firm: Aird & Berlis LLP
• Author: Amy Grenon and Lawrence Veregin

In Janssen Inc. v. Pharmascience Inc., 2022 FC 62, the Federal Court highlighted two important issues: the burden in summary trial proceedings and the evidentiary burden for proving inducement of patent infringement. The Court's findings with respect to these issues in Pharmascience differ from its findings in two other recent decisions.¹

The Court held that, once an issue is found to be suitable for summary trial, the burden to prove that issue falls on the same party who bears the onus in the underlying action. In other words, the onus on summary trial is the same as at a full trial. On the question of inducement, the Court inferred that Pharmascience would induce infringement of the claimed dosing regimen through recommendations in the product monograph, even though the monograph did not explicitly identify the infringing step and the prescribing physician would have a final say in the exact regime.

Background

Janssen commenced an action against Pharmascience under the PM(NOC) Regulations in relation to Canadian Patent No. 2,655,335 ("335 Patent") and paliperidone palmitate (INVEGA SUSTENNA'), which is used to treat schizophrenia.

The 335 Patent pertains to dosing regimens for injections of paliperidone palmitate that employ a specific dose on Day 1 (a "loading dose") that is followed by different doses on later days ("maintenance doses"). In general, the 335 Patent contains claims for prefilled syringes for the dosing regimens and claims for use of the dosing regimens.

Janssen previously successfully asserted the 335 Patent against another generic manufacturer, Teva. In Teva, the Court found that the proposed paliperidone palmitate product would directly infringe the 335 Patent's prefilled syringe claims, but that there would be no direct or induced infringement of other claims.² The Teva decision is currently under appeal.

Pharmascience is not seeking approval for prefilled syringes of its proposed paliperidone palmitate product.³ Relying on the Teva decision, Pharmascience brought a motion seeking summary trial on the question of infringement.

The Burden in Summary Trial

As we have previously reported, there is an ongoing trend in the Federal Court to allow more matters to be determined in whole or in part by summary judgment or summary trial, including complex pharmaceutical litigation.⁴

However, there has been conflicting case law as to which party bears the burden of proof on the merits on summary trial. Some jurisprudence (e.g. Viiv⁵) suggested...