Court File and Parties

Court File No.: CV-11-420115 Date: 20171201 Ontario Superior Court of Justice

Between:

APOTEX INC. Plaintiff

-and-

ELI LILLY AND COMPANY and ELI LILLY CANADA INC. Defendants

Before: F.L. Myers J.

Counsel: Nando De Luca and Jerry Topolsky, counsel for the plaintiff Patrick Smith and Todd J. Burke, counsel for the defendants

Heard: November 20, 2017

Endorsement

[1] In a valiant but ultimately futile effort to bring proportionality to this action, I heard what I had hoped would be an attenuated refusals motion in which the parties might focus on what was truly needed to get the case to trial. It is apparent that the parties have much more on their respective plates than just this one piece of litigation. So their positions are driven by far wider considerations. Unless or until the court determines that the parties have consumed more than their fair share of scarce public resources, their battles appear to be destined to continue as unrelenting as the 500 year war between Eminiar VII and Vendikar. [i]

[2] Despite my efforts to resolve refusals summarily, an issue arose that required written submissions and this decision.

[3] Lilly seeks to question Apotex about a communication that occurred between Apotex and the government during the abbreviated new drug submission process whereby Apotex’s drug product, that is the focus of this action, obtained approval under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133. Apotex argues that its drug approval process is off limits to Lilly. Apotex says that Lilly has no standing to challenge or to go behind Health Canada’s decision making process under which Apotex obtained its regulatory approval.

[4] Apotex is correct. Lilly has no standing and no right to challenge Apotex’s drug approval. Apotex Inc. v. Pfizer Canada Inc. (27 November 2015), Ottawa, T-1736-10 (F.C.T.D.), at pp. 5-7.

[5] In Apotex Inc. v. Abbott Laboratories Ltd., 2017 ONSC 1348, Quigley J. held:

Patentees do not have standing to speak to the date of approval any more than they have standing to speak to the merits or science of the submissions made to the Minister pursuant to the FDA Regulations. I accept the position of Apotex's counsel that it is improper for the court, on a NOC prohibition application, to take into consideration the propriety of an ANDS; rather, the court should assume that the Minister does not ignore his or her legal duties under the FDA Regulations and would refuse to issue a NOC in the absence of a proper submission for approval. [Notes omitted]

[6] In that case, Abbott argued that Health Canada had issued its approval to Apotex’s drug by mistake. Quigley J. was clear that this line of collateral attack on the drug approval process was not open to Abbott.

[7] In Pfizer the plaintiff sought to amend its claim to “allege, in essence, misconduct by Apotex with respect to the regulatory approval process.” The court refused to grant leave to amend finding that the proposed pleadings that mounted a collateral attack would “hijack” the proceedings.

[8] So, how does Lilly propose to make its document request relevant and admissible? The cause of action alleged by Apotex is a statutory right to damages under s. 8 of the regulation. The section entitles Apotex to damages calculated from the date on which a notice of compliance would have been issued to it but for Lilly’s wrongful attempted assertion of it patent rights. Subsection 8 (1)(a)(ii) provides that the regulatory date applies to the commencement of the period for measuring Apotex’s damages “unless the court concludes that a date other than the certified date is more appropriate”.

[9] Apotex relies on the Health Canada approval date and says that Lilly cannot challenge that date in light of the case law recited above. However, in both of those cases, the originator proposed pleadings that undermined the approval obtained by Apotex. Abbott alleged that the government approved Apotex’s drug by mistake. Pfizer undermined the manner in which Apotex obtained approval. The Courts in both cases said that the patentee cannot challenge the regulatory approval.

[10] Lilly is not doing that. Lilly has pleaded that a later date is a more appropriate date for the commencement of Apotex’s damages under s. 8 (1)(a)(ii). While the court in Pfizer did not allow amendments to undermine the regulatory approval, it did allow para. 22C of the proposed pleading which the court described as follows:

Paragraph 22(C) is simply a denial that Apotex has any entitlement to damages in respect of the First Apotex Product because the representations of Apotex are factors to be considered by the Court under section 8(5) (b) of the Patented Medicines (Notice of Compliance) Regulations (Regulations) in awarding damages and in respect of section 8(1) (a)(ii) of the Regulations concerning the “start date” for any damages owed to Apotex. [Emphasis added.]

[11] In Abbott, at para. 137, Quigley J. described the outcome of Pfizer as follows:

The Court was of the view that the proposed amendment "opens the door for Pfizer to transform this proceeding from a section 8 damages claim into an inquiry into what Health Canada might or might not have done in different circumstances. In my view they do not have the standing to do so." Only amendments that went to quantum of damages rather than entitlement were allowed. [Notes omitted and emphasis added.]

[12] The question proposed by Lilly in this case is probative of its pleading of an alternative the start date for the calculation of Apotex’s damages under s. 8 (1) (a)(ii) and is therefore permissible. This is not to say that the trial judge will allow argument that runs afoul of the prohibitions in the case law. I make no finding on the relevant factors or limits of permissible arguments under s. 8 (1) (a)(ii) that may justify a court in finding a better date for the accrual of damages is some time after the date of regulatory approval for Apotex’s drug. But the regulation provides a clear right to make the argument. Lilly has pleaded it appropriately. The document sought is referred to in a document obtained under freedom of information legislation. There is no doubt as to its authenticity or reliability.

[13] During the hearing, I ruled that proportionality limits requests for additional documents to those which can be shown to contain probative information. It is generally not proportional to demand production of secondary documents that may just be fertile sources where one might expect or hope to find probative information. The former are relevant. The latter is fishing.

[14] The question asked at Item 144 is relatively narrow and, for the foregoing reasons, in my view is probative of an issue that is properly pleaded. Accordingly the question is to be answered.

[15] Costs in the cause.

F.L. Myers J. Date: December 1, 2017

[i] “A Taste of Armageddon,” Star Trek, Season 1, Episode 23, NBC, February 23, 1967.