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Federal Court finds US supply disruptions relevant to Apotex’s ability to supply the Canadian abiraterone market

In the context of Apotex’s section 8 action against Janssen, Janssen brought a motion under Rule 51 of the Federal Courts Rules to appeal an Order of a Case Management Judge who declined to compel Apotex to answer certain discovery questions related to Apotex’s capacity to supply the US abiraterone acetate market.  

Prior to the examination for discovery of Apotex’s representative, Janssen had produced documents purporting to contain US abiraterone sales data. Janssen alleged that this data showed that Apotex suffered a supply disruption in and around March 2019, at which point Apotex’s US market share had dropped from approximately 32.2% to 2.7%. As a result, Janssen took the position that Apotex did not have manufacturing capacity to supply the US market.

During the examination for discovery of Apotex’s representative, Apotex refused to answer questions related to its manufacturing and sales in the US market. Janssen brought a motion to compel answers to these questions, which was ultimately dismissed by the Case Management Judge on the basis of relevance.

Justice Southcott applied the palpable and overriding error standard in assessing the Case Management Judge’s Order.

Relevance

Relevance for the purposes of discovery is defined by reference to the pleadings. Janssen pleaded that Apotex did not have the capacity to manufacture enough abiraterone to satisfy the Canadian market. Janssen argued that its questions regarding Apotex’s ability to supply the US market were relevant because it was pursuing a theory that Apotex suffered a supply disruption in and around March 2019 and did not have capacity in its Signet plant to supply the US market, which would offer insight into Apotex’s ability or inability to supply the Canadian market.  

In responding to the motion, Apotex asserted that it had already provided Janssen with the evidence it needed to understand its manufacturing capacity. Apotex relied on evidence of annual production capacities from 2017-2021, arguing that this evidence showed its Signet plant had more than sufficient capacity to supply the entire Canadian market. Apotex also made the evidentiary argument that Janssen was unable to rely on the US data documents it had included in its motion record without establishing the authenticity of those documents and/or proving their contents.

As a preliminary point, Justice Southcott noted that the Court assesses relevance by reference to the facts pleaded by the parties, not by reference to evidence produced in the litigation. Justice Southcott rejected Apotex’s evidentiary argument because Janssen relied on the US data documents only to provide the Court with context for its line of questioning. Janssen offered this evidence to provide a foundation and explain why its questions were more than a fishing expedition. Justice Southcott explained that it would unduly restrict the scope of discovery if the Court were to impose too high an evidentiary standard on a party seeking to explain why it considers particular questions relevant.

Justice Southcott agreed that the disputed questions may fairly lead to a train of inquiry that could assist in responding to Apotex’s claim and held that, in absence of any reasons for finding the disputed questions irrelevant, the Order demonstrated a palpable and overriding error. The disputed questions satisfied the test for relevance as informed by Janssen’s pleading.

Proportionality

Justice Southcott likewise held that there was no compelling evidence before the Court that the disputed questions were overbroad or that answering them would be unduly burdensome for Apotex.

Justice Southcott granted Janssen’s motion and set aside the Case Management Judge’s Order.

A copy of the decision is available here.