Federal Court Rejects Trial Of Common Issues And Allows Pleadings Amendment Re: Supply Disruptions In Abiraterone Acetate Amended Section 8 Actions

• Published date: 30 November 2022
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Biotechnology & Nanotechnology
• Law Firm: Smart & Biggar
• Author: Mr Brandon Heard

As previously reported, the Federal Court found Janssen's Canadian Patent No. 2,661,422 ("422 patent") - which relates to treatment of prostate cancer in humans by co-administration of abiraterone acetate (marketed by Janssen as ZYTIGA) and prednisone - invalid in actions under the Patented Medicines (Notice of Compliance) Regulations (Regulations) against Apotex, Dr. Reddy's, and Pharmascience. The Federal Court of Appeal upheld the invalidity of the 422 patent on appeal.

In three separate actions, Apotex, Dr. Reddy's, and Pharmascience seek damages from Janssen pursuant to amended section 8 of the Regulations for their lost sales of abiraterone acetate. Dr. Reddy's and Apotex's actions are scheduled to be tried consecutively in June 2023 which would be the first trial in actions under amended section 8 of the Regulations. The Pharmascience trial has not yet been scheduled. On October 27, 2022, Justice Southcott decided three motions addressing procedural issues in these proceedings.

Court dismisses Janssen's motion for common issues to be heard together

The Court dismissed Janssen's motion that evidence on issues common to the three actions should be heard together: Apotex Inc v Janssen Inc, 2022 FC 1473.

The Court disagreed with Janssen that the level of commonality between issues was sufficient. Each case requires the construction of a separate "but-for world" with different parameters (e.g., relevant time period and product dosages, as Dr. Reddy's sells only the 250 mg product whereas Apotex and Pharmascience sell both 250 mg and 500 mg products). Additionally, evidence may differ between the separate but-for worlds as to what third-party generic manufacturers would have done in the abiraterone acetate market.

Next, the Court weighed the prejudice asserted by each party. Janssen asserted that, absent a common hearing, it would (a) need to call evidence from five non-parties across multiple actions, (b) face different burdens to prove the plaintiffs' activities in each trial, (c) incur expenses for the testimony of Janssen's witnesses three separate times, and (d) face the risk of inconsistent factual findings.

Justice Southcott found that the following categories of prejudice asserted by the plaintiffs "militate strongly" against a common hearing, and "outweigh the prejudice advanced by Janssen":

• Adverse witnesses may be cross-examined by all plaintiffs, each with their own unique interests, with the potential for an adverse impact on an individual...