Apotex Inc. v. Janssen Inc.

Apotex Inc. v. Janssen Inc.
Court (s) Database
Federal Court Decisions
Date
2023-02-14
Neutral citation
2023 FC 216
File numbers
T-1168-21, T-607-21, T-732-22
Decision Content
Date: 20230214
Dockets: T-607-21
T-1168-21
T-732-22
Citation: 2023 FC 216
Ottawa, Ontario, February 14, 2023
PRESENT: The Honourable Mr. Justice Southcott
Docket: T-607-21
BETWEEN:
APOTEX INC.
Plaintiff
and
JANSSEN INC., JANSSEN ONCOLOGY, INC. AND BTG INTERNATIONAL LTD.
Defendants
Docket: T-1168-21
AND BETWEEN:
DR. REDDY’S LABORATORIES LTD. AND DR. REDDY’S LABORATORIES, INC.
Plaintiffs
and
JANSSEN INC., JANSSEN ONCOLOGY, INC.
AND BTG INTERNATIONAL LTD.
Defendants
Docket: T-732-22
AND BETWEEN:
PHARMASCIENCE INC.
Plaintiff
and
JANSSEN INC., JANSSEN ONCOLOGY, INC.
AND BTG INTERNATIONAL LTD.
Defendants
ORDER AND REASONS
I. Overview
[1] This decision relates to motions brought by the Defendants (Janssen Inc., Janssen Oncology, Inc., and BTG International Ltd. [together, Janssen]) in three actions under section 8 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-113 [Regulations]. In each action, the Plaintiff or Plaintiffs (Apotex Inc. [Apotex] in Court File T-607-21 [the Apotex Action]; Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc. [together, DRL] in Court File T-1168-21 [the DRL Action]; and Pharmascience Inc. [PMS] in Court File T-732-22 [the PMS Action]) claim damages for lost sales of abiraterone acetate against the Defendants.
[2] In each action, Janssen moves under Rule 233 and Rule 238 of the Federal Courts Rules, SOR/98-106 [Rules] for an order entitling it to document production and oral discovery in relation to the companies that are the Plaintiffs in the other two actions, as follows:
in the Apotex Action, Janssen seeks production from and discovery of DRL and PMS;
in the DRL Action, Janssen seeks production from and discovery of Apotex and PMS; and
in the PMS Action, Janssen seeks production from and discovery of Apotex and DRL.
[3] For the reasons explained in greater detail below, each of the motions is granted in part. Based on the applicable test and considering the discretionary factors under Rule 233, I find that Janssen should receive most, but not all, of the documentary production it requests in each action. I also find that Janssen has not satisfied the test under Rule 238, applicable to a motion for non-party discovery, as it has failed to demonstrate that it would be unfair not to allow it an opportunity to conduct such discoveries.
II. Background
[4] Janssen markets the prostate cancer drug abiraterone acetate in Canada as ZYTIGA and listed Canadian Patent No. 2,661,422 [the 422 Patent] on the Patent Register in respect of ZYTIGA.
[5] Each of the Plaintiffs sought to market a generic abiraterone acetate product, and each challenged the 422 Patent. In turn, Janssen commenced actions under section 6 of the Regulations against each of the Plaintiffs in respect of their abiraterone acetate products. The parties agreed to have the actions heard together at a common trial. On January 6, 2021, Justice Phelan dismissed Janssen’s claims and declared the 422 Patent to be invalid (see Janssen Inc v Apotex Inc, 2021 FC 7). This decision was recently upheld on appeal (see Janssen Inc v Apotex Inc, 2022 FCA 184).
[6] Justice Phelan’s dismissal of the section 6 actions crystallized causes of action for the Plaintiffs pursuant to section 8 of the Regulations. Each of the Plaintiffs in turn commenced an action claiming damages for lost sales of their respective abiraterone acetate products. Those actions were commenced on the following dates:
Apotex Action (T-607-21): April 12, 2021;
DRL Action (T-1168-21): July 23, 2021; and
PMS Action (T-732-22): April 8, 2022.
[7] The DRL Action and the Apotex Action are scheduled to be tried consecutively in June 2023. The PMS Action has not yet been set down for trial.
[8] In each action, Janssen pleads that, if the Plaintiff(s) in that action had entered the market earlier than they did in the real world, they would have faced competition from several other generic pharmaceutical companies in the but-for world [BFW]. In these motions, Janssen asserts in particular that the Plaintiff(s) in each action would have faced competition from the Plaintiffs in the other two actions.
[9] For example, Janssen asserts that, given that Apotex’s product was approvable before or during the BFW time periods of each of DRL and PMS, the potential entry of Apotex into the abiraterone acetate market in those BFWs is relevant to assessing DRL’s alleged damages in the DRL Action and PMS’s alleged damages in the PMS Action. Janssen argues that the key questions to be addressed in relation to that defence assertion are whether the non-party generic (in this example, Apotex) had the ability and motivation to supply its abiraterone acetate product in the BFWs of the relevant Plaintiffs (in this example, DRL in the DRL Action and PMS in PMS Action). On this basis, Janssen seeks, in each of the DRL Action and the PMS Action, documentary production by Apotex and discovery of the individual(s) at Apotex primarily responsible for deciding whether and when Apotex would have launched an abiraterone product in the relevant BFW.
[10] Similarly, Janssen seeks documentary production and discovery in relation to DRL in the Apotex Action and the PMS action, and likewise seeks documentary production and discovery in relation to PMS in the Apotex Action and the DRL Action.
[11] On November 2, 2022, Janssen served three motion records on each of Apotex, DRL, and PMS. Each of its Notices of Motion (which are materially the same) is filed in two of the section 8 actions and seeks relief against the company that is not a party to either of those actions (i.e., the Plaintiff in the other section 8 action) [the Non-Party]. Each Notice of Motion seeks the following relief:
an order pursuant to Rule 233 directing that the Non-Party produce the documents listed at Schedule “A” to the Notice of Motion (which lists 10 categories of documents);
an order pursuant to Rule 238 granting Janssen leave to examine for discovery the individual(s) at the Non-Party primarily responsible for deciding whether and when the Non-Party would have launched an abiraterone product;
in the alternative:
an order requiring production of transcripts from examinations for discovery of the Non-Party (that took place in the section 8 action in which the Non-Party is the Plaintiff) and select productions identified by Janssen as Confidential Information-CEO (meaning “counsel’s eyes only”) pursuant to an existing Protective Order; and
an order granting Janssen leave to examine for discovery the individual(s) at the Non-Party primarily responsible for deciding whether and when the Non-Party would launch an abiraterone product on relevant topics not canvassed in the transcript and documents produced pursuant to the alternative relief.
[12] As will be explained in more detail later in these Reasons, Janssen’s counsel advised at the hearing of these motions that it was prepared to withdraw the requests for alternative relief described above.
[13] On January 16, 2023, each of Apotex, DRL, and PMS served responding motion records in the actions in which it was not a party (i.e., responding to Janssen’s motion seeking to have it make non-party production and submit to non-party discovery). On January 20, 2023, each of Apotex, DRL, and PMS served responding motion records in the action in which it is the Plaintiff (i.e., responding to Janssen’s motion seeking non-party production and non-party discovery in its section 8 action). In their written representations and their oral submissions at the hearing of these motions on January 31, 2023, each of Apotex, DRL, and PMS adopted the others’ submissions in opposing the relief Janssen requests.
III. Issue
[14] Having considered the various arguments advanced by the parties in support of their positions, and the parties’ respective articulations of the issues, I conclude that their arguments can be analyzed under the following issues:
Whether Janssen’s motions represent, or if granted its requested relief would represent, a breach of the implied undertaking applicable to evidence obtained by compulsion from a party to litigation;
Whether the Non-Parties should be compelled to produce any of the documents sought by Janssen; and
Whether Janssen should be granted leave to examine any individuals at the Non-Parties.
IV. Analysis
A. General principles
[15] Before turning to the parties’ arguments, it is useful to review general principles that apply to Janssen’s motions. I do not understand any of these principles to be in dispute.
[16] As previously noted, Janssen brings its motions under Rule 233 and Rule 238. These Rules are somewhat related, as both address pre-trial discovery of a person who is not a party to an action. Rule 233 relates to production of documents by a non-party, and Rule 238 relates to examination for discovery of a non-party. The portions of these Rules relevant to the arguments in these motions read as follows:
Production from non-party with leave
Production d’un document en la possession d’un tiers
233 (1) On motion, the Court may order the production of any document that is in the possession of a person who is not a party to the action, if the document is relevant and its production could be compelled at trial.
233 (1) La Cour peut, sur requête, ordonner qu’un document en la possession d’une personne qui n’est pas une partie à l’action soit produit s’il est pertinent et si sa production pourrait être exigée lors de l’instruction.
….
….
Examination of non-parties with leave
Interrogatoire d’un tiers
238 (1) A party to an action may bring a motion for leave to examine for discovery any person not a party to the action, other than an expert witness for a party, who might have information on an issue in the action.
238 (1) Une partie à une action peut, par voie de requête, demander l’autorisation de procéder à l’interrogatoire préalable d’une personne qui n’est pas une partie autre qu’un témoin expert d’une partie, qui pourrait posséder des renseignements sur une question litigieuse soulevée dans l’action.
….
….
Where Court may grant leave
Autorisation de la Cour
238 (3) The Court may, on a motion under subsection (1), grant leave to examine a person and determine the time and manner of conducting the examination, if it is satisfied that:
238 (3) Par suite de la requête visée au paragraphe (1), la Cour peut autoriser la partie à interroger une personne et fixer la date et l’heure de l’interrogatoire et la façon de procéder, si elle est convaincue, à la fois :
(a) the person may have information on an issue in the action;
a) que la personne peut posséder des renseignements sur une question litigieuse soulevée dans l’action;
(b) the party has been unable to obtain the information informally from the person or from another source by any other reasonable means;
b) que la partie n’a pu obtenir ces renseignements de la personne de façon informelle ou d’une autre source par des moyens raisonnables;
(c) it would be unfair not to allow the party an opportunity to question the person before trial; and
c) qu’il serait injuste de ne pas permettre à la partie d’interroger la personne avant l’instruction;
(d) the questioning will not cause undue delay, inconvenience or expense to the person or to the other parties.
d) que l’interrogatoire n’occasionnera pas de retards, d’inconvénients ou de frais déraisonnables à la personne ou aux autres parties.
[17] Orders under both Rule 233 and Rule 238 are discretionary and indeed “exceptional” remedies that require a stranger to the litigation to involve themselves in a proceeding before the Court (see Janssen Inc v Pfizer Canada Inc, 2019 FCA 188 [Janssen] at para 5; Guides, Inc v Videotron GP, 2019 FCA 321 [Rovi FCA] at para 16). Rovi
[18] Rule 233 establishes two threshold requirements. For the Court to grant an order under this Rule, the moving party must establish both that the documents sought are relevant and that they would be compellable at trial. To be relevant, the requested documents must relate to the issues between the parties, be useful, and be likely to contribute to resolving the issues (see Tippett v Canada, 2020 FC 714 at para 22).
[19] However, because an order under Rule 233 is discretionary, establishing the relevance and compellability of the documents sought is necessary, but not sufficient, for the Court to order production. Merely establishing these two threshold criteria does not entitle a litigant to a production order (O’Leary v Ragone, 2021 FC 185 [O’Leary] at paras 13-14). Given the exceptional nature of the remedy sought, the Court must still exercise its discretion to determine whether it should grant the remedy in the circumstances (O’Leary at para 14).
[20] In O’Leary, Associate Judge Tabib noted that there is no set list of factors that the Court must, or can, consider in exercising its discretion on a Rule 233 motion. However, she identified the following factors that had been previously identified in the jurisprudence as being potentially relevant (at para 15):
Whether the information can be obtained from another party or source;
The necessity of the order;
Whether an order is premature;
The necessity and probative value of the documents in light of documents already disclosed;
The privacy interests of, or prejudice to, other non-parties;
Confidentiality concerns;
Public interest in disclosure;
Delay, cost or disruption in the proceedings;
The non-party’s involvement in the matter under dispute;
The specificity of the request for production; and
Any costs to the producing party.
[21] Applicable jurisprudence also establishes that Rules 233 and 238 should not be regarded as prescribing two insular sets of requirements or criteria. The fact that certain factors, such as fairness between the parties, are expressly set out in Rule 238, but not in Rule 233, does not foreclose their consideration on a motion for production under Rule 233 (Janssen at para 10; O’Leary at para 17).
[22] Rule 238 governs the discovery examination of non-parties. To obtain leave under Rule 238 for discovery of a person who is a non-party, the moving party must at a minimum satisfy the Court of the following four requirements expressly enumerated in Rule 238(3) (see Rovi Guides, Inc v Videotron GP, 2019 FC 1220 [Rovi] at para 48, aff’d Rovi FCA):
The person may have information on an issue in the action;
The party has been unable to obtain the information informally from the person or from another source by any other reasonable means;
It would be unfair not to allow the party an opportunity to question the person before trial; and
The questioning will not cause undue delay, inconvenience or expense to the person or to the other parties.
[23] Once the moving party has satisfied the Court of these requirements, the Court again retains discretion to dismiss a Rule 238 motion (Rovi FCA at para 17). I understand the parties to properly agree that, in exercising that discretion, the Court can look to the factors identified in O’Leary.
B. Whether Janssen’s motions represent, or if granted its requested relief would represent, a breach of the implied undertaking applicable to evidence obtained by compulsion from a party to litigation
[24] Before turning to the parties’ arguments specific to Rules 233 and 238, it is necessary for the Court to consider a threshold issue raised by the Non-Parties that they submit should preclude Janssen from being granted any relief in these motions. The Non-Parties argue that, if Janssen is granted its requested relief, it would give rise to a breach of the implied undertaking applicable to evidence obtained by compulsion from a party to litigation. Indeed, they go further in arguing that Janssen has already breached that undertaking by bringing these motions.
[25] The Federal Court of Appeal explained the nature of the implied undertaking rule in its recent decision in FibroGen, Inc v Akebia Therapeutics, Inc, 2022 FCA 135 [FibroGen], at paragraph 45:
45. The implied undertaking rule applies to both documentary and oral information obtained on discovery: such evidence is not to be used except for the purpose of that litigation unless and until the undertaking is varied by court order (Juman at para. 4) or until the documents are admitted into evidence and become part of the public court record. Whether documents produced or answers given are privileged and confidential is irrelevant to the undertaking (Juman at para. 27).
[26] This passage from FibroGen references the decision of the Supreme Court of Canada in Juman v Doucette, 2008 SCC 8 [Juman], which explained the rationale for the implied undertaking rule (at paras 24-27). Pre-trial discovery is an invasion of a private right to be “left alone with your thoughts and papers.” While the public interest in getting at the truth in a civil action outweighs the examinee’s privacy interest, the latter is nevertheless entitled to a measure of protection. Moreover, a litigant who has some assurance that the documents and answers will not be used for a purpose collateral or ulterior to the proceedings in which they are demanded will be encouraged to provide a more complete and candid discovery.
[27] Before using information or documents subject to the implied undertaking rule, the party seeking to use the information or documents must apply to the Court for leave to do so and must specify the purpose or purposes for using the information and explain the reasons why relief is justified, with both parties being heard on the application (Juman at para 30).
[28] Each of the Non-Parties asserts that Janssen’s motions breach, or if granted would give rise to a breach, of the implied undertaking rule, because Janssen is using or seeking to use evidence, obtained by compulsion from the Non-Party through documentary production or discovery examination in the section 8 action in which it is the Plaintiff, outside the section 8 proceeding in which the evidence was provided. The Non-Parties argue that the breach of the rule is particularly apparent in the alternative relief sought in Janssen’s Notices of Motion, in which Janssen expressly seeks the production of discovery examination transcripts and documentary evidence that were generated in another proceeding.
[29] The Non-Parties refer the Court to Justice Manson’s recent decision in Janssen Inc v Apotex Inc, 2022 FC 1746 (a piece of litigation that involves some of the same parties, but is unrelated, to the present matters), in which Janssen wished to use documents and information, that had been compelled from Apotex in one proceeding, in separate subsequent proceedings. Janssen brought a motion to vary the confidentiality order, governing the proceeding in which the evidence had been produced, to allow that evidence to be used in the subsequent proceedings. Relying on FibroGen and the fact that the evidence had never been tendered in open court at trial, Justice Manson held that the evidence was still subject to the implied undertaking rule and that it would be inappropriate to vary the confidentiality order until Janssen had sought relief from its undertaking (at paras 15 and 20).
[30] Each Non-Party takes the position that, before Janssen can seek the Rule 233 and Rule 238 relief advanced in these motions, it must seek relief from the implied undertaking in the section 8 action in which the Non-Party (in its capacity as Plaintiff) has provided documentary production and discovery evidence under compulsion.
[31] In the matters at hand, Janssen does not dispute that the documentary production and discovery evidence it has obtained from the Plaintiffs in each of the section 8 actions is subject to the implied undertaking rule. Indeed, in apparent recognition of the application of the rule to the alternative relief sought in its Notices of Motion, Janssen’s counsel advised at the hearing of these motions that Janssen was prepared to withdraw its request for the alternative relief. I am therefore not required to rule on that request. However, in the interests of explaining my reasoning in relation to the implied undertaking arguments, I note that I would have had little difficulty concluding that the implied undertaking would have been engaged by that alternative relief. In that relief, Janssen sought to use in one proceeding the particular evidence that was generated under compulsion in another proceeding.
[32] In contrast, as explained below, I am not convinced that the principal relief (and now the only relief) that Janssen seeks in these motions similarly engages the implied undertaking rule.
[33] As I understand the Non-Parties’ position, they assert that Janssen is already in possession of evidence of the sort that it seeks through these motions and that it is therefore necessarily making collateral use of that evidence in presenting these motions. The Non-Parties rely in particular on the following statement by Janssen in paragraph 22 of its written representations in support of these motions (the following quote being, by way of example, from the written representations seeking production and discovery of Apotex):
22. Given Apotex’s burden to prove that it could and would have entered the abiraterone market as early as [patent hold date] in the Apotex Section 8 Action, these issues have been the subject of documentary and oral discovery in the Apotex Section 8 Action. …
[34] Reading the paragraphs in Janssen’s representations that precede paragraph 22, it is clear that the “issues” referenced in the statement are Apotex’s ability and motivation to supply its abiraterone product. This statement forms part of Janssen’s explanation of attempts it had made, through dialogue between the parties, to acquire consensually the evidence it seeks. Janssen explains that it proposed to Apotex using the discovery examination and document productions from the Apotex Action as non-party production and discovery in the DRL Action and PMS Action. Effectively, Janssen was proposing a negotiated result comparable to the alternative relief that it subsequently advanced, and then withdrew, in these motions. However, it received no response to its proposal.
[35] In response to the Non-Parties’ argument based on paragraph 22 of its representations, Janssen submits that it cannot be inferred from this statement that it is making use of evidence obtained in another proceeding for purposes of seeking documentary production and discovery under Rules 233 and 238. Janssen argues that stating that Apotex was discovered in its section 8 action on its ability and motivation to supply its abiraterone product is comparable to stating that a party to a negligence action was discovered on the applicable duty and standard of care. While perhaps not a perfect parallel, I take Janssen’s point that a section 8 claimant’s ability and motivation to supply its product are typical issues in a section 8 action (see Eli Lilly Canada Inc v Teva Canada Limited, 2018 FCA 53 at paras 85-88). Moreover, given the fact that Janssen made the statement (at paragraph 22 of its written representations) in the context of explaining its efforts to negotiate the alternative relief, I do not infer from that statement that it is relying on the evidence already in its possession in seeking orders under Rules 233 and 238.
[36] That said, in my view there is merit to the Non-Parties’ position that a litigant, which is in possession of evidence that is subject to the implied undertaking in one proceeding, must be cautious in how it approaches another proceeding in which the same evidence may be relevant. Clearly, a litigant need not have actually produced the evidence in another proceeding in order to have breached the undertaking.
[37] For example, in Goodman v Rossi, 1995 CarswellOnt 146, 125 DLR (4th) 613 (Ont CA) [Goodman], one of the authorities upon which the Non-Parties rely, the plaintiff commenced a defamation action based on a document she obtained from the defendant in another piece of litigation in which she had sued the defendant for wrongful dismissal. The defendant sought to stay the defamation action, because it was based on evidence obtained in the other proceeding. Before the Court of Appeal for Ontario, the issue was whether the relevant document was subject to an implied undertaking and, if so, whether the plaintiff should be granted relief from the undertaking in order to permit pursuit of the defamation proceeding (see paras 1-3).
[38] In recognizing the existence of an implied undertaking, the Court of Appeal noted that the jurisprudential prohibition against using a document for a “collateral or ulterior purpose” does not use that phrase in a pejorative sense, but rather prohibits use for any purpose different from that which was the only reason that the document was provided in a civil action (at para 47). Goodman does not appear to set out an express analysis and conclusion that the plaintiff’s commencement of the defamation action represented a use of the relevant document in breach of the undertaking. However, it is clear that this was the Court’s conclusion, as it analysed and ultimately dismissed the Plaintiff’s request for relief from the implied undertaking (at paras 59-71).
[39] While Goodman involved a fact pattern far different from the matter at hand, and therefore offers limited instruction on whether Janssen’s motions give rise to a breach of the implied undertaking, the Non-Parties also rely on Quenneville v Robert Bosch GmbH, 2018 ONSC 6775 [Quenneville], which involved a motion for non-party documentary discovery. Quenneville arose in the context of a class action against the defendant, Robert Bosch GmbH [the Bosch Action], the supplier of software to a number of Volkswagen entities [VW] in an alleged conspiracy to install deceptive emissions measurement devices in diesel engine automobiles sold in Canada. The plaintiffs in the Bosch Action had previously commenced, and in turn settled, a class action against VW in relation to the same subject matter [the VW Action]. The same class counsel represented the plaintiffs in both actions.
[40] In the VW Action, VW produced some 3 million documents, which were subject to a protective order issued in that matter. Following settlement of the VW Action, the plaintiffs moved in the Bosch Action for an order requiring VW (a non-party in that action) to produce the same 3 million documents. In rejecting the plaintiffs’ motion, the Court relied in part on a conclusion that they had breached rule 30.1.01(3) of the Ontario Rules of Civil Procedure [Ontario Rules] (at para 8). (This rule, called the deemed undertaking rule, is a codification of a principle comparable to the implied undertaking that exists as a matter of common law in the Federal Court’s jurisprudence.) Indeed, the Court stated that, when class counsel received these documents for purposes of the VW Action, they were simultaneously receiving the documents for purposes of the Bosch Action and thereby in breach of the protective order and the deemed undertaking (at para 25).
[41] Ultimately, the Court’s dismissal of the motion appears to have turned on both the breach of the undertaking and other factors relevant to a motion seeking non-party production (at paras 40-53). This reasoning included the Court’s concern that the larger portion of the 3 million documents produced in the VW Action were not relevant to the Bosch Action, and class counsel had made no attempt to tailor or refine their request (at paras 42-43).
[42] In oral submissions, Janssen’s counsel questioned the reasoning (in Quenneville at para 25) that class counsel had breached the deemed undertaking, just by receiving the documents, due to their role as counsel in both the VW Action and the Bosch Action. I also struggle with that particular reasoning. However, elsewhere in the decision, the Court describes the breach as resulting from the fact that class counsel had undertaken not to use the information other than for the VW action (at para 27). That reference to “use” of the information is consistent with the Court’s summary of its reasoning that it was the bringing of the motion that represented the breach of the deemed undertaking (at para 8).
[43] Quenneville would be a particularly relevant authority for the Court to consider if Janssen were advancing its request for the alternative relief set out in in its Notices of Motion. It illustrates the concern inherent in the implied undertaking about seeking to use documents, produced under compulsion in one proceeding, in a separate proceeding, without first seeking relief from the undertaking. However, in my view, moving for orders under Rules 233 and 238, where neither the relief sought nor the evidentiary support for the relief is framed in terms of evidence that was produced in another matter, does not represent a breach of the undertaking.
[44] In further support of its position that it is not using evidence subject to the implied undertaking in bringing the present motions, Janssen argued at the hearing that the terms of the relief sought against the Non-Parties is essentially the same as that which was sought in the Rule 233 and Rule 238 motions previously filed by Janssen and directed at other generic abiraterone manufacturers who are not parties to section 8 litigation with Janssen.
[45] The record before the Court in the current motions confirms that, in these section 8 proceedings, Janssen moved for non-party discovery of six other pharmaceutical companies, which motions were resolved and did not proceed to a hearing [the Other Motions]. The motion materials in the Other Motions are not themselves included in the records filed by the parties in the current motions. However, those materials form part of the Court’s files in these proceedings, and Janssen’s counsel took the position at the hearing of the current motions that the Court is entitled to review those materials to confirm Janssen’s assertion. Counsel for the other parties did not dispute this position and indeed did not dispute Janssen’s assertion that the Other Motions sought relief on essentially the same terms as the current motions.
[46] In the absence of any detailed argument comparing the terms of the relief sought in the Other Motions to that sought in the motions at hand, I decline to engage in such an analysis. However, the fact that Janssen pursued the Other Motions in support of Rule 233 and Rule 238 relief in relation to other pharmaceutical companies, which had not been the subject of previous documentary oral discovery, supports a conclusion that Janssen need not be relying on evidence that is subject to the implied undertaking to be seeking such relief in the present motions.
[47] Moreover, Janssen’s written representations in support of these motions do not rely on any such evidence in support of the relevance of the requested information. Rather, they rely on applicable jurisprudence to the following effect:
in section 8 cases, a significant factor in quantifying the claimant’s lost profits is the presence of competitors in the BFW, which affects the claimant’s market share and pricing (Apotex Inc v Merck Canada Inc, 2012 FC 1235 [Alendronate] at paras 43-44 and 51; Apotex Inc v Takeda Canada Inc, 2013 FC 1237 at para 61); and
in assessing whether a competitor could and would have entered the market, relevant factors include when the competitor would have received its Notice of Compliance [NOC], whether it had the capacity to manufacture or acquire the product, and whether it was motivated or dissuaded from entering the marketplace (Alendronate at para 44; Apotex Inc v Sanofi-Aventis, 2012 FC 553 [Apotex Ramipril] at paras 151-152, rev’d on other grounds 2014 FCA 68).
[48] In conclusion, the record in these motions does not support a conclusion that Janssen’s motions represent, or will give rise to, a breach of the implied undertaking through use in other proceedings of the evidence previously provided by the Non-Parties as Plaintiffs in their section 8 actions.
C. Whether the Non-Parties should be compelled to produce any of the documents sought by Janssen
[49] As explained earlier in these Reasons, the threshold requirements prescribed by Rule 233 are relevance and compellability.
(1) Relevance
[50] One of the principal arguments advanced by the Plaintiffs in opposing Janssen’s Rule 233 motion (as well as its Rule 238 motion) is that Janssen has failed to establish the relevance of the documentary production it seeks. Rule 233 imposes on the moving party the burden to establish such relevance. As explained above in these Reasons, to discharge this burden, Janssen relies on authorities identifying the significance of market competition, and the factors to be considered in assessing such competition, when quantifying a section 8 claimant’s lost profits. Janssen also provides more detailed submissions explaining why it considers the 10 categories of documents it is seeking to be relevant to regulatory hurdles faced by the Non-Parties, their capacity to manufacture or acquire product, or their motivation to launch their product.
[51] I do not understand the Plaintiffs to take issue with Janssen’s position on the factors that are relevant to assessing market competition. They do advance submissions challenging the relevance of the particular categories of documents that Janssen seeks, to which submissions I will return later in these Reasons. However, more fundamentally, they argue that Janssen has failed to satisfy the relevance requirement because its pleadings do not identify the Non-Parties as competitors and do not identify the circumstances that Janssen asserts would have permitted the Non-Parties to enter the BFW that is constructed in each of the section 8 actions.
[52] The Plaintiffs are correct that Janssen’s pleadings do not identify any of the Non-Parties by name as relevant competitors. By way of example, in the Apotex Action, the pleading upon which Janssen relies to establish relevance is paragraph 22(a) of its Amended Statement of Defence, which reads as follows:
22. In the alternative, Janssen relies upon subsections 8(5) and 8(6) of the Amended Regulations and pleads that the following relevant factors should be taken into account by the Court when assessing the amount of compensation, if any, to be awarded to Apotex:
a. If Apotex had entered the market in Canada prior to January 11, 2021, several other generic pharmaceutical companies would have also entered the market in Canada at or about the same time as Apotex;
[53] Janssen’s pleading references “several other generic pharmaceutical companies” and does not identify either DRL or PMS by name. Janssen’s Amended Statement of Defence in each of the DRL Action and PMS Action is similarly constructed. However, I have difficulty concluding that this lack of specificity renders any of these pleadings deficient in establishing the relevance of evidence that bears upon market competition and the effect of that competition upon the quantification of the section 8 claims.
[54] I appreciate that insufficiently defined pleadings can represent a basis for the Court to decline a motion to compel discovery from third parties (see Eli Lilly Canada Inc v Sandoz Canada Incorporated, 2009 FC 345 at para 25). However, to the extent the Plaintiffs in the section 8 actions are taking the position that Janssen’s failure to plead by name specific generic competitors deprived it of an understanding of Janssen’s defence, I agree with Janssen’s argument that it was available to the Plaintiffs to move for better particulars.
[55] It was also available to the Plaintiffs to discover Janssen on the identities of the generic competitors that were the subject of Janssen’s defence. No discovery evidence has been filed in these motions, and I understand that discoveries have not yet taken place in the PMS Action. However, by way of example, I note that an earlier interlocutory decision by this Court in the DRL Action (in which DRL sought determination of a question of law under Rule 220) reflects that, during discovery in that action, Janssen identified Apotex and PMS as two of the generic companies that it asserts are relevant under section 8(5) and 8(6) of the Regulations (see Dr. Reddy’s Laboratories Ltd v Janssen Inc, 2022 FC 1672 at para 11 [the Rule 220 Decision]).
[56] As identified above, the Plaintiffs also argue that Janssen’s pleadings are deficient in that they do not identify the circumstances that Janssen asserts would have permitted the Non-Parties to enter the BFW that is constructed in each of the section 8 actions. In advancing this argument, the Plaintiffs rely on Apotex Inc v Sanofi-Aventis, 2014 FCA 68 [Apotex Ramipril FCA], aff’d 2015 SCC 20. In Apotex Ramipril FCA, the Federal Court of Appeal considered whether, in a circumstance where a patentee has exercised its right under section 7 of the Regulations to a statutory stay against generic entry and does not resolve or renounce that right in relation to certain generics in the real world, it is available to the patentee when subsequently defending a claim for section 8 damages to argue that such generics (other than the section 8 claimant) would have entered the market in the BFW free of that obstacle to entry (at paras 155-162 and 186-187).
[57] I pause to note my understanding that the interpretation, and significance to the facts of the present actions, of authorities including Apotex Ramipril FCA that have interpreted section 8 of the Regulations will be an issue for determination at trial. As reflected in the Rule 220 Decision, DRL takes the position that, in the circumstances considered in Apotex Ramipril FCA, it is as a matter of law unavailable to the patentee to argue that generics who were subject to the statutory stay in the real world would have entered the market in the BFW. In contrast, Janssen takes the position that Apotex Ramipril FCA and other authorities establish that, while there is a legal presumption in a section 8 proceeding that a patentee would have taken the same steps in the BFW that it did in the real world, it is open to the patentee (or any party) to lead evidence that events in the BFW would have unfolded differently than they did in the real world. As the Rule 220 Decision dismissed DRL’s motion, this legal issue remains to be resolved at trial, and I will not presently elaborate any further upon that issue.
[58] However, independent of how this legal issue may ultimately be resolved at trial, the Plaintiffs challenge the relevance of Janssen’s Rule 233 production request on the basis that it does not explain in its pleading or in any evidence adduced on this motion how the Non-Parties in any of the section 8 actions would escape operation of the Regulations so as to become market participants in the applicable BFW.
[59] In support of their position that Janssen’s motion should be denied in the absence of sufficient evidentiary support, the Plaintiffs refer the Court to Apotex Ramipril at paragraph 149, which held that the defendant in a section 8 action cannot simply allege that other generics would have entered the market without leading evidence in support of such assertions. However, Apotex Ramipril was the trial decision in a section 8 action, in which the Court was addressing the evidential burden at trial. Apotex Ramipril does not support a conclusion that a party faces such a burden on a production motion.
[60] The Plaintiffs also argue that support for their position can be found in this Court’s decision in an earlier Rule 105 motion, brought by Janssen in these section 8 actions, seeking to have heard together evidence on issues that it asserted were common to all three actions (see Apotex Inc v Janssen Inc, 2022 FC 1473