The Canadian life sciences sector saw several notable developments in 2023. This article summarizes a number of the more remarkable court decisions, as well as other life sciences-related developments from 2023.
1. Decisions under the PM(NOC) Regulations
The Federal Court of Appeal and Federal Court issued several decisions in respect of patent infringement and invalidity actions, including in actions commenced under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations"). We highlight seven of these decisions below.
Janssen Inc. v. Apotex Inc., 2023 FCA 253: Serving serial NOAs raising different issues found to be an abuse of process
In Janssen v Apotex, Janssen successfully appealed the Federal Court's decision dismissing Janssen's motion for summary judgment. The Federal Court of Appeal found that Apotex litigating by instalments through serving multiple Notices of Allegations (NOA) amounted to an abuse of process.
Apotex served an NOA in 2021 alleging non-infringement of the CA2,655,335 Patent (335 Patent). Invalidity was not raised. Janssen was ultimately successful in that case, and Apotex's generic product was found to infringe the 335 Patent (2022 FC 107).
Apotex then served four new NOAs alleging invalidity. Janssen commenced actions against Apotex pursuant to section 6 of the PM(NOC) Regulations. Janssen then brought a motion for summary judgment on the basis of res judicata, abuse of process and the doctrine of election.
The Court of Appeal found that the lower court applied the wrong legal test in analyzing whether there was an abuse of process. In particular, with respect to its abuse of process reasoning, the Federal Court incorrectly focused on the distinction in the Regulations between non-infringement allegations and invalidity allegations, and the propriety of Apotex's service of multiple NOAs. Since the doctrine of abuse of process is about the inherent power of the Court to prevent the misuse of its procedure, the focus should instead have been on the proceedings before the Court.
Read the full decision here.
Sandoz Canada Inc v. Janssen Inc, 2023 FCA 221: Sound prediction threshold remains the same
The Federal Court of Appeal in Sandoz v Janssen provided a clarification and summary of the jurisprudence regarding the threshold required to establish a sound prediction of utility. The Court reaffirmed that the threshold required remains a "prima facie reasonable inference," a standard that remains unchanged from what was established by the Supreme Court's 2002 Wellcome/AZT decision (2002 SCC 77) and Eli Lilly v. Novopharm (2010 FCA 197).
The Court of Appeal, in alignment with the Federal Court's ruling in 2022 FC 715, upheld that the utility of Janssen's CA2,659,770 combination patent (macitentan and a PDE5 inhibitor to treat pulmonary arterial hypertension) could indeed be soundly predicted, and dismissed Sandoz's appeal.
Read the full decision here.
Apotex Inc v. Janssen Inc, 2023 FCA 220: A generic's adjusted product monograph can still induce infringement
In Apotex v Janssen, the Federal Court of Appeal calls into question the reliance on product monograph carve-outs to avoid infringement. The Court upheld the Federal Court's decision that the market and sale by Apotex of its Apo-Macitentan product would induce infringement of Janssen's CA2,659,770 combination patent (macitentan and a PDE5 inhibitor to treat pulmonary arterial hypertension), even though Apotex would only market its product for monotherapy.
The Court of Appeal affirmed that the legal test for inducing infringement, as first outlined in Corlac (2011 FCA 228), as follows:
- The acts of infringement must have been completed by the direct infringer;
- The completion of the acts of infringement must be influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not take place; and
- The influence must be knowingly exercised by the inducer; in other words, the inducer knows that this influence will result in the completion of the acts of infringement.
Since the parties agreed that the first prong of the test was established, the Court focused on the second and third prongs. The Court of Appeal found that the Federal Court was correct in determining that the Apotex product monograph would influence physicians to prescribe combination treatment, even though it does not explicitly mention such a treatment. The absence of explicit instruction and...
