COURT FILE NO.: CV-11-429541
DATE: 20180206
SUPERIOR COURT OF JUSTICE – ONTARIO
RE: Apotex, Plaintiff/Responding Party
AND:
Schering Corporation, SANOFI-AVENTIS, Sanofi-Aventis Deutschland GMBh and sANOFI-aVENTIS CANADA INC., Defendants/Moving Parties
BEFORE: S.F. Dunphy J.
COUNSEL: Nando De Luca and Daniel Cappe, for the Plaintiffs/Responding Party
Marc Richard, for the Defendant/Moving Parties Schering Corporation
Gunars Gaikis and Brandon Heard, for the Defendants/Moving Parties, SanofiAventis, Sanofi-Aventis Deutschland GmbH and Sanofi-Aventis Canada Inc.
HEARD at Toronto: December 20, 2017
REASONS FOR DECISION
[1] More than six years ago, the plaintiff began this claim against the defendants alleging what is clearly a novel cause of action notwithstanding that the claim is framed as falling under a statute that is only slightly younger than the works of William Shakespeare. The case languished at the pleadings stage for almost six years while the parties worked their way through a number of legal challenges. The sums involved in this litigation are potentially staggering and all parties have lavished upon this litigation all of the means necessary to pursue or defend their positions vigorously.
[2] On May 25, 2016, I dismissed a motion by the defendants to strike the claim and placed the matter under case management in an attempt to shepherd it past the pleadings stage in which it had become stuck towards an actual trial on the merits.
[3] While there were some bumps in the road, the parties had managed to get discoveries completed subject to a pending motions (on both sides) and worked according to an agreed case timetable. The matter was scheduled to be set down for trial by mid-February 2018.
[4] Then the Supreme Court of Canada released its decision in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36 on June 30, 2017.
[5] In AstraZeneca, the Supreme Court of Canada overturned the “promise doctrine” – a doctrine applied in a number of cases before lower courts where patents held by the “original” pharmaceutical companies had been struck down at the instance of “generic” pharmaceutical companies such as the plaintiff Apotex. Among the cases that had applied this now-discarded doctrine was a 2009 Federal Court decision of Snider J. that declared invalid a patent held by (or licensed to) the defendants in this case on the application of the plaintiff.
[6] The invalidity of that patent and the use made by the defendants of such invalid patent to preclude Apotex from selling competing pharmaceutical products lies at the very heart of Apotex’s claims in this case. As a result of AstraZeneca, the defendants have decided to seek my leave to permit them to amend their respective Statements of Defence.
[7] On this motion, I am asked to decide whether the defendants should be entitled to plead that they are not “estopped or otherwise precluded” from taking the position that Apotex cannot rely on the June 29, 2009 decision of the Federal Court declaring the “206 Patent” held by (or licensed to) the defendants to be invalid. The defendants all take the position that there is at least an arguable case that the decision of the Federal Court invalidating the “206 Patent” would not have been made but for the application of the now-invalidated promise doctrine.
[8] While I recognize that amendments are only to be refused in the clearest of cases, I find this to be such a case. For the more detailed reasons that follow, I am dismissing the defendants’ motion.
[9] These amendments seek to walk a fine line between confronting the doctrines of res judicata and collateral attack head on and merely damning them with faint praise. In a breathtaking display of legal syncretism, the moving parties urge me to find that the same patent can be acknowledged to be invalid while the question of the defendants’ liability to the plaintiff and the possible damages arising can nevertheless be decided as if this were not so.
[10] The judgment of the Federal Court declaring the 206 Patent to be invalid remains a court order that is valid and binding for all purposes and cannot be made the object of a collateral attack in other proceedings even if it is now alleged that the reasons for such judgment have subsequently been wholly or partially undermined.
[11] It is possible that the Federal Court might have decided the question of the validity of the defendant’s patent differently in the light of AstraZeneca. It is possible that it might have reached the same decision. It is possible that different evidence would have been led or issues pursued. Allowing the proposed amendments would inevitably require the entire re-litigation of an issue that has been finally decided by a court of competent jurisdiction. That is something that our legal system quite rightly forbids.
[12] There must be an end to litigation if litigation is not to put an end to us.
[13] Unless and until the Federal Court amends, varies or overturns the judgment declaring the 206 Patent invalid, the defendants cannot plead that the very same patent was nevertheless valid at the relevant time. The in rem declaration of invalidity by the Federal Court is not a sort of Schrodinger’s cat, dead and alive at the same time depending upon who looks and why. The issue of the validity of the 206 Patent is not an open one.
[14] Whether my decision is founded narrowly upon s. 62 of the Patent Act or more broadly upon the application of the principles of res judicata and collateral attack is a distinction without a difference since both result in the same outcome. The motion for leave to amend must be dismissed.
Factual Background
[15] I reviewed the nature of the claims and some of the procedural history of this case in my decision released on May 27, 2016 (Apotex Inc. v Schering Corporation, 2016 ONSC 3407) and I shall not review that history further here. In particular, I described in some detail the operation of the Patent Medicines (Notice of Compliance) Regulations (mercifully referred to by all as the “PMNOC Regulations”) that are relevant to the procedural history of this case in some detail there.
(i) History of the Ramipril wars
[16] For better or for worse, this claim is but one chapter in what must can only be described as an epic struggle between these parties over a drug known as “Ramipril”. The battle lines were drawn soon after Schering was issued Canadian Patent No. 1,341,206 on March 20, 2001 (for convenience sake, the patent is referred to by all of the parties as the “206 Patent”), a decision that itself was the product of another lengthy battle, the initial application dating from 1981.
[17] The 206 Patent was held by Schering and licensed to the Sanofi defendants at all material times. Apotex wished to manufacture and sell its own version of Ramipril to consumers. Their road was not a simple one. Among other things, Apotex has dealt with seven separate patents related to Ramipril, has become involved in ten judicial review proceedings and a variety of patent infringement law suits. The various rounds in this on-going battle have gone to the Federal Court of Appeal on at least three occasions and leave was sought and denied to the Supreme Court of Canada on one occasion with an appeal being dismissed by the Supreme Court of Canada on another. Those are just the hearings I am aware of. Mercifully, I have been given only a high-level overview of the battles that appear to have started about the same time as my first class in law school.
[18] Two of these prior proceedings are of particular relevance to this proceeding and the pleading amendment motions before me. By way of very high-level summary, Sanofi’s predecessor Aventis applied to the Federal Court in 2003 for a prohibition order preventing the Minister from issuing to Apotex a Notice of Compliance without which Apotex could not market its version of Ramipril. The application was brought pursuant to the PMNOC Regulations. Apotex responded to the application as it was entitled to do and alleged, among other things, that the prohibition order sought should not issue because the 206 Patent was itself invalid. The matter was heard by MacTavish J. in June 2005 and resulted in a 372 paragraph decision (Aventis Pharma Inc. v. Apotex Inc., 2005 FC 1283).
[19] The decision of MacTavish J. was to dismiss the claim for the issuance of a prohibition order. The reasons for that decision were the conclusion of MacTavish J. that the 206 Patent was invalid. In so concluding, MacTavish agreed with some of Apotex’s pleaded grounds of invalidity and disagreed with others. Among the grounds of invalidity accepted by MacTavish J. was the allegation that the utility of the compounds described (one of which was Ramipril) had neither been demonstrated nor soundly predicted at the time of the application for a patent.
[20] The decision of MacTavish J. was upheld at the Federal Court of Appeal in Aventis Pharma Inc. v. Apotex Inc., 2006 FCA 64. Among other things that arise from a review of the reasons, Richard C.J. is the fact that the Court of Appeal was not required to deal with Apotex’s appeal of the rejection of certain of their theories by MacTavish J. (including the theory of double-patenting that Apotex withdrew at the appeal stage). Leave to appeal this decision to the Supreme Court of Canada was denied (2006 CanLII 26361 (SCC)).
[21] Following the decision of the Federal Court of Appeal, Apotex was able to receive the required permission from the Minister to go to market with its version of Ramipril and began doing so in early 2007.
[22] The decision of MacTavish J. was confined to the purposes of s. 6 of the PMNOC Regulations and did not result in an in rem declaration that the 206 Patent was invalid even if a finding of invalidity was the basis for her decision. Nature abhors a vacuum and so also it would seem do drug companies. Despite the lengthy trial and detailed decision on the question of the validity of the 206 Patent, the entire question was destined to be re-visited in a trial de novo in a proceeding capable of making a definitive, in rem decision.
[23] The defendants were first off the mark and began a fresh Federal Court proceeding claiming that Apotex was breaching their 206 Patent by selling Ramipril pursuant to the Notice of Compliance they had been issued by the Minister. Apotex then responded by counterclaiming for the very in rem declaration of invalidity that they could not receive from MacTavish J. in that more limited-in-scope prohibition proceeding under s. 6 of the PMNOC Regulations.
[24] A further 31 trial days of evidence on the merits of the matter and 16 trial days of evidence on damages ensued. The end result was a 143-page decision of Snider J. issued on June 29, 2009 (2009 FC 676). She concluded (at para. 355) that Apotex was entitled to a declaration that the Claims 1, 2, 3, 6 and 12 of the 206 Patent are invalid (Ramipril being one such Claim). The appeal from that decision to the Federal Court of Appeal was dismissed on November 2, 2011 (2011 FCA 300).
[25] There were other fields of battle upon which the parties locked horns over Ramipril. Apotex brought a claim for compensation in accordance with the PMNOC Regulations that resulted in payment of $215 million in compensation after a further trip to the Federal Court of Appeal and eventually the Supreme Court of Canada (Sanofi-Aventis v. Apotex Inc., [2015] 2 SCR 136, 2015 SCC 20). That proceeding is not directly relevant to this motion although an issue in this litigation is the degree to which the scheme of the PMNOC Regulations and the compensation received by Apotex under them are a “complete code”. It is sufficient for present purposes to note that none of the defendants are attempting to obtain a return of the compensation paid in this proceeding.
(ii) AstraZeneca
[26] The AstraZeneca decision was heard on November 8, 2016 and the Supreme Court of Canada released its decision on June 30, 2017. At the risk of over-simplification, I shall attempt to summarize the salient points arising from the AstraZeneca decision for the purposes of this motion.
[27] The case involved a different drug (Esomeprazole) but with a very similar procedural history to Ramipril. Prohibition proceedings by the patent-holder were commenced in Federal Court under the PMNOC Regulations that were denied. This allowed the generic manufacturer to secure permission to sell its product. Subsequently, a patent infringement action was brought followed by a counter-claim for a declaration of invalidity of the underlying patent. Rennie J. found that the patent in question was invalid for lack of utility. In finding the drug lacked utility, Rennie J. concluded that the patent application contained two promises of utility, one of which was plainly demonstrated. Applying the “promise doctrine”, Rennie J. declared the entire patent to be invalid for failure to demonstrate utility of both identified promises.
[28] When the matter arrived at the Supreme Court of Canada, Rowe J. found that the “promise doctrine” that had evolved in recent years in Federal Court jurisprudence represented a misinterpretation of the Patent Act (R.S.C., 1985, c. P-4). The error the Court found was in requiring that the utility requirement of s. 2 of the Act had to be demonstrated or soundly predicted for any disclosed use of the invention. Rowe J. found that the requirement of utility in s. 2 of the Patent Act is satisfied if established by demonstration of sound prediction as of the filing date for at least one use related to the subject-matter of the patent: AstraZeneca at para. 55.
[29] In reviewing the history of the promise doctrine in the Federal Court, Rowe J. mentioned the decision of Snider J. (and the Federal Court of Appeal decision affirming it) as one of several examples where “in recent years, the Federal Courts have applied this doctrine to determine whether a patent has sufficient utility”: AstraZeneca at para. 32.
[30] The particulars of Snider J.’s Ramipril decision were not reviewed in any greater detail at the Supreme Court of Canada that this one reference.
(iii) Proposed pleading amendments
[31] The Sanofi defendants proposed amendments (i) add particulars regarding the reasons of Snider J. for declaring the 206 Patent to be invalid, (ii) add factual claims regarding the reasons of the Federal Court of Appeal in rejecting the defendants’ appeal from Snider J.; (iii) plead that “Snider J. would not have found the ‘206 Patent invalid had she applied the correct legal analysis in Apotex’s ‘206 Patent Invalidity Action”; and (iv) plead that “in view of the special circumstances, including the Supreme Court of Canada’s decision, Sanofi is not estopped or otherwise precluded from its position in the present pending litigation that Apotex cannot rely on the ‘206 Patent Invalidity from Apotex’s ‘206 Patent Invalidity Action and/or under the Regulations, in respect of any relief in its claim”. The reference in the pleading to the litigation under the “Regulations” refers to the decision of MacTavish J. referenced above which decision is alleged in a footnote to the proposed amendments also to have “turned on the application of the incorrect analysis of utility”.
[32] Schering’s proposed amended pleading does not beat about the res judicata bush. It directly pleads that the decision invalidating the 206 Patent was “decided based on wrong legal principles”, that Apotex has suffered no loss because “the claims of the 206 Patent were valid but for the improper application of the promise doctrine”, that “the 206 Patent’s claims have always been valid and were valid until the 206 Patent expired”[^1] and that “[a]ny determination of Apotex’s claim must be made based on the proper validity determination of the 206 Patent and correct legal principles of patent law”.
[33] Apotex naturally opposes the proposed amendments as being an impermissible collateral attack on the decision of Snider J. In addition, Apotex provided a summary of the reply that it would intend to file were the amendments allowed.
[34] Apotex’s position, in summary, is that if Pandora’s Box is to be opened and the defendants allowed to re-litigate one aspect of the case decided by Snider J. then it is only fair that all issues be open to re-litigation. In other words, the defendants cannot cherry-pick, disregarding the elements of her decision they dislike while holding Apotex to the rest.
[35] Needless to say, Apotex’s proposed Reply opens the prospect of litigation without limit on complex factual issues that have already been the object of two separate trials on the merits by seeking to re-visit the question of patent validity yet again.
(iv) Section 62 Patent Act issue
[36] Shortly after the hearing on this matter, I raised with the parties the question of s. 62 of the Patent Act. The question arose in the following fashion.
[37] Both sides had focused their oral and written arguments primarily upon the doctrines of res judicata, issue estoppel and collateral attack. In the course of oral argument, I asked a number of questions of the parties regarding the in rem nature of the patent invalidity declaration made by Snider J., the impact of that declaration and in particular whether such a declaration did not result in the patent being found to be void ab initio. No party had relied explicitly upon s. 62 of the Patent Act in responding to my questions during oral argument nor made reference to it in their extensive written arguments although it is this section of the Patent Act that answers the question I raised.
[38] In a prior motion in this proceeding[^2], I had found that the effect of the ruling of Snider J. in respect of the 206 Patent was that this patent was found to be void ab initio, a ruling that was predicated upon s. 62 of the Patent Act and had been the object of discussion in oral argument on that occasion. That motion, of course, preceded AstraZeneca.
[39] Section 62 of the Patent Act provides (in both languages):
A patent, or part of a patent, that is voided by a judgment shall be and be held to have been void and of no effect, unless the judgment is reversed on appeal as provided in section 63.
Le brevet ou la partie du brevet qui a été annulé par un jugement est nul et de nul effet et est tenu pour tel, à moins que le jugement ne soit infirmé en appel en vertu de l’article 63.
[40] I asked the parties to direct further argument in writing to this issue and, in particular, whether the Superior Court has jurisdiction to entertain litigation seeking to determine the validity of the 206 Patent that the Federal Court has already determined to be invalid.
[41] The parties responded to this invitation with their customary thoroughness. Extensive written briefs on this issue were provided to me by all of the parties.
Issues to be decided
[42] There is no serious issue taken by any of the parties with the general principles applicable to motions under rule 26.01 of the Rules of Civil Procedure to amend pleadings. The court “shall” grant leave to amend on such terms as are just unless prejudice would result that cannot be compensated in costs or an adjournment. However, the court’s role as gatekeeper is not a pure rubber stamp. Amendments that are scandalous, frivolous or vexatious, are an abuse of process or disclose no reasonable cause of action (or, in this case, defence) may nevertheless be refused. However, such determinations are not to be lightly made. As I put it in my introduction, leave should only be refused in the clearest of cases.
[43] The positions taken by the parties in argument require me to address two issues in particular:
(a) Does the doctrine of “special circumstances” apply to permit the proposed amendments that are otherwise barred by the doctrine of res judicata or collateral attack?
(b) Would the proposed amendments cause Apotex any non-compensable prejudice?
[44] I shall deal with these in reverse order only because the second issue is so swiftly disposed of.
Analysis and discussion
(i) Non-compensable prejudice?
[45] Apotex filed no evidence on this motion and relies on the doctrine of presumed prejudice. In the present case, Apotex suggests that prejudice can be inferred from the fact that the proposed amendments seek to hold Apotex to the findings made by Snider J. in her decision while setting aside the central conclusion of invalidity she made. Apotex pleads that amendments this late in the case that fundamentally alter the entire complexion of the litigation are prejudicial in and of themselves.
[46] At the end of the day, Apotex’s claim to be prejudiced amounts to no more than a description of all of the policy reasons underlying the doctrine of res judicata in the first place. Apotex’s position is that it presented its case – selected witnesses, filed evidence, pursued issues and abandoned others, challenged findings on appeal or let them stand – based on the legal landscape as they understood it at the time. It would be fundamentally unfair to assume a different outcome without re-running the entire trial.
[47] The prejudice alleged is not non-compensable however. There is no evidence before me that any evidence has been lost. The challenge to the 602 Patent was not fundamentally a memory exercise after all. The evidence presented to Snider J. and MacTavish J. before her was highly technical, scientific evidence. I have nothing before me to suggest that any such evidence has been lost or cannot be re-created. The trial could be re-run, or at least I have no evidence before me that it cannot.
[48] The suggestion of prejudice stems from a confusing the reasons of Snider J. with her decision. Her decision (very clearly stated in paragraph 355) was to make a declaration that the relevant (to this proceeding) portion of the 206 Patent was invalid. There is simply no logic to the proposition that, for the purposes of this proceeding at least, the Apotex should be precluded from relying upon the decision of Snider J. itself, but the defendants may nevertheless treat as settled all of the reasons for that same decision. That amounts to asking this court to assume the role of the Federal Court of Appeal and to substitute one outcome for another.
[49] The remedy to the prejudice is obvious and Apotex has anticipated it by providing a copy of the very detailed Reply it would intend to file to the proposed amended Statements of Defence, a Reply that would effectively re-litigate the entire question of the validity of the Ramipril patent from scratch. Sanofi at least indicated in oral argument that it had no particular objection to permitting Apotex to file its intended Reply.
(ii) Does the doctrine of “special circumstances” apply to permit the proposed amendments that are otherwise barred by the doctrine of res judicata or collateral attack?
[50] There can be no doubt that the doctrines of res judicata and collateral attack are both at least prima facie applicable and would require me to deny the defendants’ motion.
[51] Issue estoppel is of course the branch of res judicata at issue here since the present action concerns a very different cause of action than the one before Snider J. even if the invalidity of the 206 Patent is a condition precedent to it. Issue estoppel requires satisfaction of three conditions. These are: (1) that the same question has been decided; (2) that the judicial decision which is said to create the estoppel was final; and, (3) that the parties to the judicial decision or their privies were the same persons as the parties to the proceedings in which the estoppel is raised: Angle v. M.N.R., [1975] 2 SCR 248 at p. 254, 1974 CanLII 168 (SCC).
[52] The doctrine of collateral attack was described by McIntyre J. in Wilson v. The Queen, [1983] 2 SCR 594, 1983 CanLII 35 (SCC) at S.C.R. p. 599 as follows:
It has long been a fundamental rule that a court order, made by a court having jurisdiction to make it, stands and is binding and conclusive unless it is set aside on appeal or lawfully quashed. It is also well settled in the authorities that such an order may not be attacked collaterally—and a collateral attack may be described as an attack made in proceedings other than those whose specific object is the reversal, variation, or nullification of the order or judgment.
[53] The decision of Snider J. decided the issue of the validity of the 206 Patent. Her decision was affirmed on appeal and is final. The parties to this proceeding are the same as the parties to the proceeding before Snider J. or are their privies. The proposed amendments, if leave were granted, would invite this court to conclude that Snider J. was wrong in her conclusions, that she would have decided differently had she but had AstraZeneca before her and that Apotex cannot rely on the invalidity of the 206 Patent. Both the doctrines of res judicata/issue estoppel and collateral attack are applicable to the moving parties' motions for leave to amend.
[54] The moving parties plead “special circumstances” to seek to avoid the application of the doctrines of res judicata and collateral attack. In support of this position, they cite the decision of the Court of Appeal in Minott v. O'Shanter Development Company Ltd., 1999 CanLII 3686 (ON CA) and the Supreme Court of Canada in Danyluk v. Ainsworth Technologies Inc., [2001] 2 SCR 460, 2001 SCC 44.
[55] In Danyluk, Binnie J. found (at para. 33) that issue estoppel is not to be mechanically applied, but requires the court to “balance the public interest in the finality of litigation with the public interest in ensuring that justice is done on the facts of a particular case” after it has determined that the three-part Angle test has been satisfied.
[56] In Minott, the Laskin J. A. found (at para. 50):
Issue estoppel is a rule of public policy and, as a rule of public policy, it seeks to balance the public interest in the finality of litigation with the private interest in achieving justice between litigants. Sometimes these two interests will be in conflict, or at least there will be tension between them. Judicial discretion is required to achieve practical justice without undermining the principles on which issue estoppel is founded. Issue estoppel should be applied flexibly where an unyielding application of it would be unfair to a party who is precluded from relitigating an issue.
[57] Apotex for its part notes that both Minott and Danyluk involved the application of issue estoppel to the decisions of administrative tribunals and were not examples of “court-to court” issue estoppel. This very distinction was noted by Binnie J. who agreed that in the case of court proceedings, such a discretion must be very limited in application even if a broader range of discretion is appropriate in the case of decisions of administrative tribunals: Danyluk at para. 62.
[58] I find that the special circumstances exception has no application to the facts of this case.
[59] While Laskin J.A. in Minott considered that the doctrine might be applicable in the case of a change in law or the discovery of new evidence or material that was not discoverable, neither situation is applicable here. There has been on change in the law. No provisions of the Patent Act relevant to the validity of the 206 Patent have been amended. It was open to the losing side before Snider J. to have advanced the arguments that succeeded before the Supreme Court of Canada in AstraZeneca to the Federal Court or the Federal Court of Appeal. They might have sought leave to appeal to the Supreme Court of Canada on those same grounds.
[60] The moving parties cite the British Columbia Court of Appeal decision in Hockin v. Bank of British Columbia, 1995 CanLII 6268 (BC CA) for the proposition that a change in the common law is able to be construed as a change of law giving rise to a special circumstance. Hockin is, in my view, quite distinguishable.
[61] Firstly, Hockin involved a considered change in the common law of trust decided by the Supreme Court of Canada. To the extent there has been a “change” effected by AstraZeneca, it has been in an aspect of the interpretation of a statutory provision that was not amended.
[62] Secondly, the Supreme Court had expressly found the prior decision of the British Columbia Court of Appeal in the same case to be in error. There was no debate about the error. That is not the case here. While it is certainly arguable that Snider J.’s decision would be found to be in error today in light of AstraZeneca, that conclusion is by no means certain.
[63] The existence of a triable issue about the existence and impact of a change in interpretation of the law is not a sufficiently special circumstance to warrant suspending the application of the doctrines of res judicata and collateral attack. Doing so here would gut these foundational doctrines of any effectiveness.
[64] The interests of justice are broader than the interests of a single party who has tried and lost an issue before a court of competent jurisdiction – in this case, effectively twice. Where, as here, the special circumstance pleaded to avoid the application of the doctrine of res judicata would effectively require the re-litigation of the entire question that was already decided after a lengthy trial, there are no special circumstances. That is precisely the public policy outcome that res judicata seeks to avoid. Litigation must have a finite end. Litigants need to get on with their lives and courts have few enough resources to process the cases they do have without having to hear them all again and again.
[65] I am fortified in my view of the proper application of the doctrine of “special circumstances” to this issue by a review of s. 62 of the Patent Act. The effect of s. 62 of the Patent Act upon the declaration made by Snider J. is that the 206 Patent was held to be void ab initio and that decision is an in rem decision. While the French version of the statute uses different words, they are to the same effect. This means that the patent was never valid and the defendants could never derive any rights from it. That determination was and remains valid for all purposes as against all persons unless and until changed by the court that made it.
[66] If I am wrong in my application of the doctrine of special circumstances, I am nevertheless of the view that s. 62 and s. 63 of the Patent Act compels the same result. There is only one avenue open by which a patent that has been declared to be void can be treated otherwise by this court – and that is by means of an appeal pursuant to s. 63 of the Patent Act. The moving parties have elected not to undertake that route.
Disposition
[67] Accordingly, I am dismissing both motions for leave to amend. The cross-motion of Apotex for leave to amend its reply is moot.
[68] Apotex is entitled to its costs. If the parties are unable to agree upon the amount – and given the frequency with which these parties find themselves on opposite sides, I am hoping that they have enough experience with each other to do so – I will accept written submissions from them on the subject.
[69] Apotex as successful party should deliver its submissions and Outline of Costs (submissions limited to five pages, exclusive of Outline or any offers to settle) within thirty days. The moving parties should reply two weeks later (same size limitations). The parties are free to modify this schedule on mutual consent without consulting me (within reason – I don’t expect to receive submissions next year).
[70] Finally, I turn to the matter of the case timetable. The parties were required to have this matter set down for trial by mid-month. They have jointly asked me to push that time out until the end of 2018. Given the unresolved discovery issues (motion currently pending) and the likelihood of review of this order being sought, the request would appear to me to be a prudent one. Order granted extending the deadline for setting this matter down for trial until December 31, 2018. There is of course nothing preventing any party from doing so sooner!
S.F. Dunphy J.
Date: February 6, 2018
[^1]: In oral argument, the parties advised me that the 206 Patent would have expired in 2018. [^2]: Apotex Inc. v Schering Corporation, 2016 ONSC 3407 at para. 24.