PFIZER CANADA INC. Appellant v. TEVA CANADA, 2016 FCA 161

Date: 20160531 Docket: A-422-14 Citation: 2016 FCA 161 CORAM: STRATAS J.A. RYER J.A. GLEASON J.A. BETWEEN: PFIZER CANADA INC. Appellant and TEVA CANADA LIMITED Respondent Heard at Toronto, Ontario, on December 1, 2015. Judgment delivered at Ottawa, Ontario, May 31, 2016. REASONS FOR JUDGMENT BY: STRATAS J.A. CONCURRED IN BY: RYER J.A. GLEASON J.A. Date: 20160531 Docket: A-422-14 Citation: 2016 FCA 161 CORAM: STRATAS J.A. RYER J.A. GLEASON J.A. BETWEEN: PFIZER CANADA INC. Appellant and TEVA CANADA LIMITED Respondent REASONS FOR JUDGMENT STRATAS J.A. A.

Introduction [ 1 ] Pfizer appeals from the judgment dated June 30, 2014 of the Federal Court ( per Zinn J.). The judgment is based on reasons dated April 3, 2014 ( 2014 FC 248 ) and subsequent reasons dated June 30, 2014 ( 2014 FC 634 ). [ 2 ] Following fifteen days of trial, the Federal Court found Pfizer liable for damages under

section 8 of the Patented Medicines (Notice of Compliance) Regulations , S.O.R. 93-133 in the amount of $92,228,000.00, pre-judgment interest in the amount of $32,539,550.36, post-judgment interest at the rate of 3.0% on $124,766,550.36 (the sum of the damages and prejudgment interest) from the date of judgment until payment, and costs.

[ 3 ] Pfizer appeals. It alleges that the Federal Court committed reversible error in a number of ways. [ 4 ] I agree with Pfizer on one of the issues it raises, namely the Federal Court’s admission of and reliance upon hearsay evidence in the trial. While this Court has the power to consider the matter without the hearsay evidence and make the judgment the Federal Court should have made, I would not exercise that power in this factually-complex circumstance where the result is unclear.

Rather, I would remit the matter to the Federal Court for redetermination. [ 5 ] Therefore, for the reasons that follow, I would allow the appeal, set aside the judgment of the Federal Court, and remit the matter to the Federal Court for redetermination on this record, excluding the hearsay evidence. I would grant Pfizer its costs of the appeal. B. Background facts [ 6 ] In the Federal Court, Teva sued Pfizer for damages arising from Pfizer's conduct under the PMNOC Regulations that improperly kept one of its corporate predecessors from selling its drug on the market.

This suit was founded upon the legislative cause of action in

section 8 of the PMNOC Regulations . [ 7 ] In this

summary of background facts, I shall describe the relevant drugs and the relevant parties and then review the portions of the PMNOC Regulations that relate to this appeal. Then I shall review what the parties did under those portions of the PMNOC Regulations that gave rise to Teva’s action for damages under

section 8 of the PMNOC Regulations . Finally, I shall review the Federal Court’s reasons. [ 8 ] Throughout these reasons, when I refer to a paragraph number in the Federal Court’s reasons, the relevant reasons are the first set of reasons dated April 3, 2014 ( 2014 FC 248 ).

(1) The relevant drug and the relevant parties [ 9 ] The innovative drug at issue in this matter is venlafaxine hydrochloride (“venlafaxine”) marketed under the name Effexor XR. [ 10 ] The appellant, Pfizer, is the corporate successor to Wyeth and Wyeth Canada. Wyeth was the innovative manufacturer of venlafaxine. In these reasons, for the purposes of describing Wyeth’s conduct before it became part of Pfizer, I shall refer to Wyeth as “Wyeth (Pfizer).” [ 11 ] The respondent, Teva, is the corporate successor to ratiopharm inc. During many of the events giving rise to its claim for damages under

section 8 of the PMNOC Regulations , Ratiopharm sought to be a generic manufacturer of venlafaxine. In these reasons, for the purposes of describing Ratiopharm’s conduct before it became part of Teva, I shall refer to Ratiopharm as “Ratiopharm (Teva).” [ 12 ] As the Federal Court noted in its reasons, Novopharm Limited and Pharmascience Inc. played a role as generic entrants into the market for venlafaxine. I shall refer to them as Novopharm and Pharmascience. Novopharm is now part of Teva. But in the interests of clarity and due to their less significant role in these reasons, it is not necessary to acknowledge their current status, as I have for Ratiopharm (Teva) and Wyeth (Pfizer).

(2) The PMNOC Regulations as they relate to this appeal [ 13 ] In order to market a new drug in Canada, an innovative drug manufacturer must, among other things, file a new drug submission and receive approval in the form of a notice of compliance from the Minister of Health.

As part of that process, the PMNOC Regulations permit the manufacturer to list in a patent register all of the relevant patents pertaining to the submission. [ 14 ] Later, a generic drug manufacturer wishing to make and market a generic version of the innovator’s drug may submit an abbreviated new drug submission demonstrating, among other things, that the generic formulation is bioequivalent to the innovator’s drug by cross-referencing clinical trials regarding safety and effectiveness undertaken by the innovator.

This dispenses with the need for the generic manufacturer to undertake its own clinical trials. [ 15 ] The generic drug manufacturer must address any patent listed in the patent register concerning the innovator drug: PMNOC Regulations , s. 5. It does so either by stating that it is not seeking the issuance of a notice of compliance until the patent expires or by alleging that the patent is not valid or will not be infringed by the making, using or selling of the generic drug.

In furtherance of the allegation, it must serve a notice of allegation which contains a detailed statement of the factual and legal bases for the allegation. [ 16 ] An innovator who wishes to challenge the allegation of invalidity or non-infringement in the notice of allegation must apply to the Federal Court within 45 days for an order prohibiting the Minister of Health from issuing a notice of compliance for the generic product before the expiry of the patent(

s) that are the subject of the notice of allegation. If the innovator does that, the Minister of Health is precluded from issuing a notice of compliance to the generic manufacturer in most cases for twenty-four months or until the prohibition application has been dismissed: PMNOC Regulations , s. 7(1). [ 17 ] A generic manufacturer may seek an order dismissing all or part of the prohibition application concerning patents it says are not eligible for inclusion on the patent register: PMNOC Regulations , para. 6(5)( a ).

If the motion is successful, the prohibition application is dismissed as against any improperly listed patents. [ 18 ] If a prohibition application is ultimately unsuccessful either at first instance or on appeal, or if it is discontinued or withdrawn, the innovator may be liable for damages for “any loss suffered during the period” : PMNOC Regulations , s. 8(1). In assessing damages, a

court is to take into account “all matters that it considers relevant” : PMNOC Regulations , s. 8(5).

(3) What happened under the PMNOC Regulations in this case [ 19 ] In this case, Wyeth (Pfizer) marketed an extended release version of venlafaxine hydrochloride under the name Effexor XR. Related to it is Canadian Patent 1,248,540, a patent that was to expire on January 10, 2006. It was listed on the Patent Register against Effexor XR. [ 20 ] In 2005, Ratiopharm (Teva) wanted to market its generic version of venlafaxine hydrochloride and filed an abbreviated new drug submission on February 24, 2005.

On December 9, 2005, Health Canada informed Ratiopharm (Teva) that it had completed its review of its abbreviated new drug submission but that it would not issue a notice of compliance until the requirements under the PMNOC Regulations were met. [ 21 ] On December 20, 2005, on the eve of the expiry of the ’540 Patent, Canadian Patent 2,199,778, covering the extended release formulation of venlafaxine was issued. On December 23, 2005, Wyeth (Pfizer) listed it on the Patent Register against Effexor XR. [ 22 ] In response, on the same day, Ratiopharm (Teva) served a notice of allegation.

In its notice of allegation, Ratiopharm (Teva) accepted that its notice of compliance for its version of venlafaxine would not issue until the expiry of the ’540 Patent, namely January 10, 2006. Ratiopharm (Teva) also alleged that the newly-listed ’778 Patent was invalid or would not be infringed by its version of venlafaxine. On February 10, 2006, Wyeth (Pfizer) applied for prohibition preventing the Minister from issuing a notice of compliance to Ratiopharm (Teva).

This triggered the automatic twenty-four month stay of the Minister’s ability to grant a notice of compliance to Ratiopharm (Teva) for its version of venlafaxine. [ 23 ] Some time passed. Then, on December 18, 2006, Ratiopharm (Teva) filed a motion to dismiss Pfizer’s prohibition application. It submitted that the ’778 Patent was not eligible for listing on the Patent Register for Effexor XR. [ 24 ] Following litigation of the motion in the Federal Court, the matter arrived in this Court. This Court agreed that the ’778 Patent was not eligible for listing on the patent register for Effexor XR.

So it granted Ratiopharm (Teva)’s motion and dismissed Wyeth (Pfizer)’s prohibition application: Ratiopharm Inc. v. Wyeth , 2007 FCA 264 , [2008] 1 F.C.R. 447 , rev’g 2007 FC 340 , 58 C.P.R. (4th) 154 . This Court released its judgment on August 1, 2007. [ 25 ] This removed the obstacles that stood in the way of Ratiopharm (Teva) receiving a notice of compliance to launch its version of venlafaxine. On August 2, 2007, the Minister granted Ratiopharm (Teva) its notice of compliance for its version of venlafaxine.

Ratiopharm (Teva) launched its product into the Canadian market on September 18, 2007. [ 26 ] Looking at this history with the benefit of hindsight, it can be said Wyeth (Pfizer) should not have listed its ’778 Patent on the patent register for Effexor XR and should not have brought a prohibition application. Put another way, Wyeth (Pfizer) improperly kept Ratiopharm (Teva)’s version of venlafaxine off the market. Under

section 8 of the PMNOC Regulations , Ratiopharm (Teva) could seek damages for that. [ 27 ] So Ratiopharm (Teva) did just that and started an action for damages in the Federal Court. Wyeth (Pfizer) counterclaimed on the ground that Ratiopharm (Teva)’s venlafaxine product infringed the ’778 Patent. Later, it discontinued that counterclaim.

(4) The Federal Court’s consideration of the damages claim [ 28 ] The Federal Court first considered the period of loss suffered that is compensable under

section 8 of the PMNOC Regulations . [ 29 ] The parties did not dispute the end date of that period of loss. Both agreed that under paragraph 8(1)(

b) of the PMNOC Regulations , the end date is the date the prohibition application is withdrawn, discontinued, dismissed or reversed. Here, that date was August 1, 2007, the date this Court dismissed Wyeth (Pfizer)’s prohibition application. [ 30 ] However, the parties disputed the start date of the period of loss. Teva submitted that the start date was January 10, 2006, the date the ’540 Patent expired.

Pfizer, on the other hand, submitted that the start date could not be earlier than February 13, 2006, the date the Minister would have issued a notice of compliance to Ratiopharm (Teva) if it had served Pfizer with a notice of allegation relating to the ’778 Patent and Pfizer had not started a prohibition application. [ 31 ] The Federal Court rejected Pfizer’s submission based on the wording of paragraph 8(1)(

a) of the PMNOC Regulations . In its view, that paragraph governed the start date. Paragraph 8(1)(

a) provides that the period starts “on the date, as certified by the Minister, on which a notice of compliance would have been issued in the absence of these Regulations, unless the court concludes that…a date other than the certified date is more appropriate.” The Minister certified the date as December 7, 2005.

That date, in PMNOC Regulations parlance, is the patent hold date. [ 32 ] Paragraph 8(1)( a ), quoted above, by default sets the start date as the date the Minister certifies a notice of compliance would have been issued in the absence of the Regulations “unless the court concludes that…a date other than the certified date is more appropriate.” Here, the Federal Court found that there was a more appropriate date, namely the date of expiry of the ’540 Patent, January 10, 2006.

It will be recalled that in its notice of allegation, Ratiopharm (Teva) accepted that its notice of compliance for its version of venlafaxine would not issue until the expiry of the ’540 Patent. [ 33 ] On this point, the Federal Court concluded as follows (at paras. 64-65): [64] In short, based on the evidence, [Wyeth (Pfizer)] knew that [Ratiopharm (Teva)] or another generic would be entering the market in January 2006 or very shortly thereafter and it chose to list the ’778 Patent in an attempt to evergreen its drug and prevent generic

competition. It knew or ought to have known that a generic ready to enter the market in January 2006 would very likely serve it with a [notice of allegation], rather than wait many more years to gain entry into the venlafaxine market. [65] In this case, but for the improper listing of the ’778 Patent on the Patent Register, all things being equal, [Ratiopharm (Teva)] would have received its [notice of compliance] and been in a position to launch its product on January 10, 2006.

The earlier Patent Hold date [December 7, 2005] is an appropriate date to commence the [period of loss]; however, because no loss is claimed by [Ratiopharm (Teva)] prior to January 10, 2006, I accept [Ratiopharm (Teva)’s] submission that January 10, 2006, is a more appropriate commencement for the [period of loss] than the Patent Hold Date [December 7, 2005]. [ 34 ] Having determined the start date and the end date for the period of loss, the Federal Court then determined a number of issues: the size of the overall market for venlafaxine, the size of the generic venlafaxine market and Ratiopharm (Teva)’s market share, the time when Ratiopharm (Teva) and its competitors’ generic products would have been listed on the provincial formularies and the entry of competitors into the generic market, the overall value of Ratiopharm (Teva)’s lost sales in the relevant period, and whether any deductions should be made under subsection 8(5) of the PMNOC Regulations .

Below, in the context of submissions made by Pfizer in this Court, I shall review in more detail the Federal Court’s reasons on the entry of Ratiopharm (Teva)’s competitors into the generic market. [ 35 ] The Federal Court then considered the central issues in this appeal: the time when Ratiopharm (Teva) would have launched its venlafaxine product and the existence of any impediments to Ratiopharm (Teva) being able to supply the market.

Teva submitted that it would have launched its product as soon as it could, on January 10, 2006, and there were no impediments to it obtaining the necessary product and supplying the full generic market.

Pfizer disagreed. [ 36 ] At the outset of its reasons on this point, the Federal Court held (at para. 148) that on the authorities Teva had to show “on a balance of probabilities that [Ratiopharm (Teva)] was able to supply the market.” In this case, that meant that Teva had to identify a supplier of the active pharmaceutical ingredient and show that that supplier had the capacity to supply the market over the relevant period. It noted (at paras. 149-152) that the only evidence offered on this point was that of Mr. Major, a witness called by Teva. Mr.

Major was a former executive of Ratiopharm (Teva) and acted in that position at all material times. [ 37 ] Mr. Major testified that Ratiopharm (Teva) relied upon a separate company, Alembic Pharmaceuticals, to manufacture its venlafaxine product. He testified that on a site visit over two weeks in 2004, he thoroughly inspected Alembic’s facility. From that, he formed the view that Alembic had sufficient capacity to produce Ratiopharm (Teva)’s venlafaxine product in the necessary quantities.

Ratiopharm (Teva) had worked with Alembic before and Alembic was an eager and enthusiastic business partner of Ratiopharm (Teva) in such matters. [ 38 ] In support of his testimony that Alembic had sufficient capacity to produce Ratiopharm (Teva)’s venlafaxine product in sufficient quantities at the relevant time, Mr. Major also relied on emails between Ratiopharm (Teva) personnel and Alembic personnel, most of which he was not copied upon. He also relied on what some colleagues at Ratiopharm (Teva) told him about Alembic’s ability to supply and on documents prepared by others.

During my analysis, below, I shall review Mr. Major’s testimony in more detail. [ 39 ] During Mr. Major’s testimony, Pfizer repeatedly objected on the ground that some of the evidence offered was inadmissible hearsay. In response to the objections, the Federal Court ruled that it would consider what weight to give to the evidence. [ 40 ] Ultimately, the Federal Court released two reasons for judgment. In the first, on April 3, 2014 (reported at 2014 FC 248 ), the Federal Court found Pfizer liable and set out certain principles for the calculation of damages.

In the second, on June 30, 2014 (reported at 2014 FC 634 ), the Federal Court quantified the damages award and calculated pre-judgment and post-judgment interest and costs. It then released its formal judgment. [ 41 ] Overall, in its first set of reasons ( 2014 FC 248 ), the Federal Court found that Alembic would have been able to supply adequate quantities of Ratiopharm (Teva)’s venlafaxine product at the relevant time. It took into account all of the evidence offered by Mr. Major, holding (at para. 153) that “[a]lthough Mr.

Major speaks as an observer rather than as an employee of Alembic, I find that his evidence is reliable.” It found that Teva had established loss under

section 8 of the PMNOC Regulations and, thus, was entitled to damages. [ 42 ] In its second set of reasons ( 2014 FC 634 ), the Federal Court quantified Teva’s damages and awarded pre-judgment and post- judgment interest and costs. C. Issues on appeal [ 43 ] Pfizer appeals to this Court. In light of the submissions the parties have advanced, these reasons address six issues:

(1) Some basic issues concerning

section 8 damages claims. Before us, the parties disagree on what must be proven and who bears the burden of proof in a claim under

section 8 of the PMNOC Regulations .

(2) The hearsay issue. Pfizer submits that the Federal Court wrongly admitted and relied upon hearsay evidence in determining whether Ratiopharm (Teva) could have supplied the market with its venlafaxine product at the relevant time in sufficient quantities.

(3) The issue whether there was palpable and overriding error on a factual finding. Pfizer attacks one of the key factual findings the Federal Court made in support of its conclusion that Ratiopharm (Teva) could have supplied the market with its venlafaxine product at the relevant time in sufficient quantities.

(4) Other

section 8 damages issues. Here Pfizer raises a number of issues. It submits that the Federal Court chose the wrong starting date for the period of Ratiopharm (Teva)’s loss and another generic drug manufacturer, Pharmascience, would have entered the

hypothetical market and competed with Ratiopharm (Teva). Also it says that the Federal Court failed to attribute Novopharm’s rebates to Ratiopharm (Teva).

(5) Pre-judgment interest. Pfizer submits that the Federal Court calculated pre-judgment interest improperly.

(6) The disposition of this appeal: what should happen now? Pfizer primarily submits that if the Federal Court wrongly admitted and relied upon hearsay evidence, the remaining admissible evidence is insufficient to support a finding that Ratiopharm (Teva) could have supplied the market with venlafaxine. Thus, Ratiopharm (Teva) suffered no loss and so this Court, making the judgment the Federal Court should have made, should now allow the appeal and dismiss Teva’s action. Teva primarily submits that Pfizer is just asking for a reweighing of the factually-suffused findings of the Federal Court and so its appeal should be dismissed. D. Analysis

(1) Some basic issues concerning

section 8 damages claims (

a) General principles [ 44 ] A plaintiff suing for damages under

section 8 of the PMNOC Regulations must show that it did in fact suffer a loss caused by the failed proceedings under the PMNOC Regulations .

Section 8 provides that compensation is available for “any loss suffered” during the relevant period—usually starting from the date on which a notice of compliance would have been issued in the absence of the Regulations as certified by the Minister of Health and ending on the date of the termination of the prohibition application . [ 45 ] If a plaintiff cannot prove a loss caused by the failed proceedings under the PMNOC Regulations during that period, it cannot recover

section 8 damages. Typically most of the plaintiff’s loss will be its inability to sell its version of a drug during that period, in other words, the financial impact of lost sales. To assess that, the court must examine what would have happened had the defendant’s triggering conduct for

section 8 damages not taken place. [ 46 ] In effect, the court is examining a hypothetical world. What would have happened in that hypothetical world must be proven by admissible evidence and any permissible inferences from that evidence. (

b) Determining lost sales in the hypothetical world [ 47 ] This Court offered much guidance on how to go about assessing the hypothetical world in Apotex Inc. v. Merck & Co., Inc. , 2015 FCA 171 , 387 D.L.R. (4th) 552 ( Lovastatin ). I acknowledge that Lovastatin concerned a claim for compensatory damages for patent infringement, not a claim for damages under

section 8 of the PMNOC Regulations . But in both types of claims the court’s task is the same: to assess a hypothetical world where the defendant’s impugned conduct did not take place. And in both the overriding principle is the same: a plaintiff is to be compensated, no more, no less: AstraZeneca Canada Inc. v. Apotex Inc. , 2013 FCA 77 , 444 N.R. 254 at para. 7 . [ 48 ] In Lovastatin , the plaintiff claimed that the defendant, by making and selling infringing product, caused it to lose sales it could have made.

The defendant submitted, among other things, that in the hypothetical world it would have been able to make the product in a non-infringing way. The sales would still have happened, cutting into the defendant’s sales just as actually happened. [ 49 ] This Court held that to make out that argument, the defendant would have had to show, on the evidence, that in the hypothetical world it would have and could have had access to sufficient quantities of non-infringing product and would have and could have used it: Lovastatin , at paras. 32, 53, 55, 70, 77 and 78 . [ 50 ] Both “would have” and “could have” are key.

Compensatory damages are to place plaintiffs in the position they would have been in had a wrong not been committed. Proof of that first requires demonstration that nothing made it impossible for them to be in that position— i.e. , they could have been in that position.

And proof that plaintiffs would have been in a particular position also requires demonstration that events would transpire in such a way as to put them in that position— i.e. , they would have been in that position. [ 51 ] Both elements have to be present. “Could have” does not prove “would have” ; “would have” does not prove “could have” : • Evidence that a party would have done something does not prove that it could have done something. I might swear up and down that I would have run in a marathon in Toronto on April 1 aiming to complete it, but that says nothing about whether I could have completed it.

Maybe I am not fit enough to complete it. • Evidence that a party could have done something does not prove that it would have done something. A trainer might testify that I was fit enough to complete a marathon race in Toronto on April 1, but that says nothing about whether I would have completed it. Perhaps on April 1 I would have skipped the marathon and gone to a baseball game instead. [ 52 ] There must be evidence that the parties “would have” and “could have” ordered and supplied material at the relevant time.

Evidence that a manufacturing plant had capacity at some time other than the relevant time for the assessment of loss under

section 8 does not necessarily mean that the plant could have and would have had capacity in the hypothetical world at the relevant time. In the words of Lovastatin , without more it is an error to “[jump] from a statement as to manufacturing capacity to conclusions as to what [a generic] could and would do in the ‘but for’ [hypothetical] world” (at para. 77). (

c) The burden of proof concerning the hypothetical world [ 53 ] In the case at bar, Teva submits that it did not bear the burden of proof concerning what would and could have happened in

the hypothetical world had its venlafaxine product not been kept off the market. It submits that Pfizer bore this burden of proof. It saysthat if evidence of what Alembic would have and could have done in the hypothetical world were needed from Alembic, Pfizer had tocall that evidence. [54] I disagree. Here too, Lovastatin, above, is instructive.

In that case, this Court held that the plaintiffs bear the burden of provingthe hypothetical world on the balance of probabilities as part of their damages claim (at para. 45). [55] This is no surprise: in suits for breach of contract or for damages caused by a wrong, such as tort cases, the plaintiff usuallybears the burden to prove what would have transpired had the breach or wrong not been committed, i.e., the persuasive burden to showwhat would have transpired in the hypothetical world: Red Deer College v. Michaels, (SCC), [1976] 2 S.C.R. 324 at p.330, 57 D.L.R. (3d) 386; Janiak v.

Ippolito, (SCC), [1985] 1 S.C.R. 146, 16 D.L.R. (4th) 1 at para. 32. The task ofconstructing the hypothetical world for the purposes of assessing compensatory damages is a factual inquiry using “robust commonsense”: Clements v. Clements, 2012 SCC 32, [2012] 2 S.C.R. 181, at paras. 8 and 9. [56] The analytical exercise of constructing a hypothetical world exists elsewhere in our law and the burden of proof remains uponthe plaintiff/complainant. For example, in some competition cases, the decision-maker must examine the state of competition in ahypothetical world.

There, the party alleging anti-competitive conduct bears the burden of proving on the basis of admissible evidencewhat would have transpired in the hypothetical world on the balance of probabilities. Mere possibilities short of probabilities do notsuffice. See generally Tervita Corp. v. Canada (Commissioner of Competition), 2015 SCC 3, [2015] 1 S.C.R. 161 at paras. 49-51 and 66,citing F.H. v. McDougall, 2008 SCC 53, [2008] 3 S.C.R. 41 at paras. 40 and 49. [57] There is nothing in

section 8 of the PMNOC Regulations that would suggest a different conclusion on the burden of proof. [58] Teva also offers the Supreme Court’s decision in Rainbow Industrial Caterers Ltd. v. Canadian National Railway Co., (SCC), [1991] 3 S.C.R. 3, 84 D.L.R. (4th) 291 in support of its submission on the burden of proof. Rainbow IndustrialCaterers does not assist Teva. [59] The plaintiff, Rainbow, was a caterer bidding on a catering contract for CN. The defendant, CN, advised Rainbow of thenumber of meals it would have to prepare. Rainbow set its bid based on that estimate. CN awarded Rainbow the contract.

But CN’sestimate was way too high and Rainbow lost money on the contract. [60] Rainbow sued for damages caused by the estimate. Rainbow bore the burden of proving on the balance of probabilities whatwould have and could have happened in the hypothetical world where CN gave a proper estimate. See Rainbow Industrial Caterers at p.14, citing D.W.

McLauchlan, “Assessment of Damages for Misrepresentations Inducing Contracts” (1987), 6 Otago L.R. 370 at p. 388.In discharge of that burden, among other things, Rainbow presented evidence concerning what bid it would have made had the estimatenot been faulty. [61] In response, CN could have worked within the hypothetical world proposed by Rainbow and defended on the basis thatRainbow did not prove that certain events in that hypothetical world could have and would have happened.

For example, CN could haveargued that Rainbow did not adduce sufficient evidence of what would have transpired in the hypothetical world to meet the balance ofprobabilities standard or to prove its quantum of damages. [62] But CN did not do that. Rather, CN offered a different hypothetical world, one where Rainbow still would have made a lowbid to win the contract and still would have lost money.

In effect, CN’s submission was that the real cause of Rainbow’s loss was not itsfaulty estimate but Rainbow’s strong desire to get the contract, even if it meant proposing terms favourable to CN. [63] The Supreme Court held that Rainbow had proven what would have happened in the hypothetical world and its quantum ofloss in that world. That discharged its burden. CN, by suggesting a different hypothetical world—in effect a different view of who causedthe loss—set up, in the words of the Supreme Court, a “new issue” or what others might perhaps call a positive defence.

In the SupremeCourt’s view, a defendant that sets up a new issue bears the burden of proving it. The plaintiff, having proved its version of thehypothetical world, does not have to disprove other speculative hypotheses. The key passage in the Supreme Court’s decision in RainbowIndustrial Caterers is at p. 15: Once the loss occasioned by the transaction is established, the plaintiff has discharged the burden of proof with respect to damages. Adefendant who alleges that a plaintiff would have entered into a transaction on different terms sets up a new issue.

It is an issue thatrequires the court to speculate as to what would have happened in a hypothetical situation. It is an area in which it is usually impossibleto adduce concrete evidence. In the absence of evidence to support a finding on this issue, should the plaintiff or defendant bear the riskof non-persuasion?

Must the plaintiff negative all speculative hypotheses about his position if the defendant had not committed a tort ormust the tortfeasor who sets up this hypothetical situation establish it? … … In my opinion, [the answer to these questions is no]. [T]here is good reason for such reversal [of burden] in this kind of case. Theplaintiff is the innocent victim of a misrepresentation which has induced a change of position. It is just that the plaintiff should beentitled to say “but for the tortious conduct of the defendant, I would not have changed my position”.

A tortfeasor who says “Yes, butyou would have assumed a position other than the status quo ante”, and thereby asks a court to find a transaction whose terms arehypothetical and speculative, should bear the burden of displacing the plaintiff’s assertion of the status quo ante. [64] In the case at bar, Teva’s position was that in the hypothetical world, Ratiopharm (Teva) could have and would have obtainedvenlafaxine in sufficient quantities from Alembic.

As Rainbow Industrial Caterers tells us, Teva bore the burden of proving that as partof its general burden to prove its loss. [65] Suppose Pfizer took the position that Ratiopharm (Teva) would not have tried to obtain venlafaxine from Alembic but insteadwould have given up and pursued another business objective, such as getting another generic drug to market. Rainbow Industrial

Caterers instructs us that Pfizer, setting up a different hypothetical, would have borne the burden of proof on that point. Put a differentway, Teva would not have borne the burden of proving that it would not have pursued a different business objective. [66] But Pfizer did not do that. Rather, it contested the very hypothetical that Teva relied upon in support of its damages claim—that Ratiopharm (Teva) would have and could have obtained venlafaxine in sufficient quantities from Alembic—and it submitted thatTeva failed to prove that on the balance of probabilities.

It is as if, in Rainbow Industrial Caterers, CN took the position that Rainbowhad failed to adduce enough evidence to prove its version of what could have and would have happened in the hypothetical world. Underthe reasoning in Rainbow Industrial Caterers, the burden of proof would have remained on the plaintiff, Rainbow. (

d) Did the Federal Court err on these matters of principle? [67] Pfizer submits that the Federal Court was not mindful of the foregoing principles. It suggests that the Federal Court only hadregard to Alembic’s willingness and potential capacity—not actual capacity—to manufacture Ratiopharm (Teva)’s venlafaxine productat the relevant time.

I disagree. [68] Faced with an allegation that a first-instance court did not apply proper principles, an appellate court must assess what thefirst-instance court did by reviewing in a holistic, organic and fair way the reasons offered by the court against the record it wasconsidering.

Often first-instance courts do not describe the principles that bear upon a case in a perfectly precise or encyclopedic way.Yet, in many such cases, a holistic, organic and fair review of their reasons against the record shows they brought to bear all correctprinciples. [69] It must be remembered that judges’ reasons—particularly after long complex trials involving many issues—are often theproduct of synthesis and distillation.

When it comes time to draft reasons in a complex case, trial judges “are not trying to draft anencyclopedia memorializing every last [relevant] morsel.” Rather, they are trying to “distill and synthesize masses of information,separating the wheat from the chaff,” in the end “expressing only the most important…findings and justifications for them”: Canada v.South Yukon Forest Corporation, 2012 FCA 165, 431 N.R. 286 at para. 50. [70] It is true that the Federal Court did not offer a great deal on the proper principles to be applied concerning the availability of s.8 damages.

However, it was mindful of these principles. [71] It proceeded on the basis that the hypothetical world that Teva had to prove was one where Wyeth (Pfizer) did not improperlylist its ’778 Patent and Ratiopharm (Teva) received its notice of compliance on December 7, 2005. In part for reasons set out later, theFederal Court committed neither legal error nor palpable and overriding error in proceeding on that basis. [72] With that hypothetical world in mind, the Federal Court held that Teva had to “show on the balance of probabilities that[Ratiopharm (Teva)] was able to supply the market” (at para. 148).

This is the “could have” portion of the analysis. And at a number ofportions in its reasons, it showed it was alive to the issue whether Ratiopharm (Teva) wanted to supply the market and whether Alembicwas willing to produce venlafaxine. This is the “would have” portion of the analysis. [73] Overall, the Federal Court was very much alive to the need for a firm causal link between failed proceedings under thePMNOC Regulations and the claimed loss.

At paragraph 57, it identified the damages as “those that the plaintiff generic suffered ‘byreason of the delayed market entry of its drug’ as stated in the Regulatory Impact Analysis Statement” for the PMNOC Regulations. Andat paragraph 61, it identified “[t]he question for the Court” as “whether there is a causal connection between the failed PMNOCproceedings and the loss claimed as damages,” stressing again that the damages claimed must be “causally connected.” [74] Even if I am wrong in my conclusion that the Federal Court was mindful of proper principles, this is of no consequence.

Theredetermination I propose will take place upon the proper principles set out in these reasons.

(2) The hearsay issue [75] Pfizer submits that even if the Federal Court appreciated that Teva had to prove it could have supplied its version ofvenlafaxine in the hypothetical world, it wrongly admitted hearsay evidence on this point. [76] Pfizer submitted that the Federal Court wrongly adopted hearsay evidence from Mr. Major. Putting aside the first-handevidence Mr.

Major offered from his two week visit to Alembic’s manufacturing facility, some of the rest of his evidence consisted ofthings told to him by Alembic’s personnel or information from other Ratiopharm (Teva) employees who got that information fromAlembic’s personnel. The former is hearsay, the latter is double hearsay. Pfizer says that the Federal Court erred in not excluding thisevidence. Teva maintained that none of this evidence was hearsay and so the Federal Court properly admitted all of the evidence. [77] I agree with Pfizer. The Federal Court improperly admitted hearsay evidence. (

a) General evidentiary principles [78] In considering evidentiary issues in complicated, high-stakes cases such as this, certain high-level principles are best keptfront of mind. [79] We start with a fundamental general principle: facts must be proven by admissible evidence: see R. v. Schwartz, (SCC), [1988] 2 S.C.R. 443 at pp. 476-77, 55 D.L.R. (4th) 1; Canadian Copyright Licensing Agency (Access Copyright) v. Alberta,2015 FCA 268, 392 D.L.R. (4th) 563 at para. 20; Canada v. Kabul Farms Inc., 2016 FCA 143 at para. 38.

Put another way, a court canact only on the basis of facts proven by admissible evidence or evidence whose admissibility has not been contested: KahkewistahawFirst Nation v. Taypotat, 2015 SCC 30, [2015] 2 S.C.R. 548 at paras. 26-27.

[80] There are rarely-occurring exceptions to this. These include circumstances where facts are subject to judicial notice (see, e.g.,R. v. Spence, 2005 SCC 71, [2005] 3 S.C.R. 458), facts are deemed or presumed by legislation to exist, facts have been found in previousproceedings in circumstances where they bind the court (see, e.g., Danyluk v. Ainsworth Technologies Inc., 2001 SCC 44, [2001] 2S.C.R. 460), and facts have been stipulated or agreed to. [81] In a civil case, absent one of those exceptions, admissibility must be the court’s first inquiry where an objection has beenmade.

If the evidence is not admissible, it is not before the court in any way and, thus, the court cannot deal with it in any way. [82] Appellate courts may interfere with admissibility decisions vitiated by errors of law: R. v. Fanjoy, (SCC),[1985] 2 S.C.R. 233 at p. 238, 21 D.L.R. (4th) 321; R. v. Evans, (SCC), [1993] 3 S.C.R. 653 at p. 664, 108 D.L.R. (4th)32; Housen v. Nikolaisen, 2002 SCC 33, [2002] 2 S.C.R. 235; and in the case of hearsay evidence, see R. v. Saddleback, 2014 ABCA166, 575 A.R. 203 at para. 8.

Any factual findings that affect the application of a law of evidence are entitled to deference: R. v.Youvarajah, 2013 SCC 41, [2013] 2 S.C.R. 720 at para. 31. [83] Recently, some rules of evidence have been liberalized, allowing for more flexibility. Seduced by this trend towardsflexibility, some judges in various jurisdictions have been tempted to rule all relevant evidence as admissible, subject to their laterassessment of weight. But according to our Supreme Court, this is heresy.

The trend towards flexibility has not undermined the need forjudges to take a rigorous approach to admissibility, separating that analytical step from others, such as determining the weight to begiven to evidence: R. v. Khelawon, 2006 SCC 57, [2006] 2 S.C.R. 787 at para. 59. [84] Sometimes courts—aiming to prevent trials from bogging down—provisionally receive evidence whose admissibility ischallenged, reserving their rulings on admissibility until later.

In some circumstances, there may be much to commend that approach; inother circumstances, the trial may be more orderly and fair if rulings are made immediately so the parties know where they stand. It is amatter of discretion. But, in the end, before a court can rely on the evidence and ascribe it any weight or draw any inferences from it, itfirst must determine its admissibility. [85] Now to the task of determining admissibility. The starting point is that evidence logically tending to prove a point isadmissible: The Queen v. Wray, (SCC), [1971] S.C.R. 272 at p. 297, 11 D.L.R. (3d) 673.

If evidence does not logicallytend to prove a point, it is irrelevant and inadmissible at the outset. [86] But there are exceptions to that general principle, stated in the form of exclusionary rules. One such rule is that hearsayevidence shall not be admitted. [87] In courts—civil, criminal or military—the hearsay rule remains in full force.

Indeed, recently the Supreme Court hasemphasized that hearsay evidence is presumptively inadmissible in court proceedings: Khelawon, above at paras. 3, 34, 42 and 59;Youvarajah, above at para. 18. [88] It is true that some administrative decision-makers can ignore the hearsay rule: see, e.g., the Supreme Court’s discussion inQuebec (Commission des droits de la personne et des droits de la jeunesse) v. Bombardier Inc. (Bombardier Aerospace Training Center),2015 SCC 39, [2015] 2 S.C.R. 789 at para. 68. But that is only because legislative provisions have explicitly or implicitly given them thepower to do that.

Absent a specific legislative provision speaking to the matter, all courts must apply the rules of evidence, including thehearsay rule. [89] The status of a particular piece of evidence as hearsay depends on its use. Hearsay is an oral or written statement that wasmade by someone other than the person testifying at the proceeding, out of court, that the witness repeats or produces in court in aneffort to prove that what was said or written is true: see, e.g., Khelawon, above at paras. 35-36; R. v. Smith, (SCC),[1992] 2 S.C.R. 915 at pp. 924-925, 94 D.L.R. (4th) 590; R. v.

Starr, 2000 SCC 40, [2000] 2 S.C.R. 144 at para. 162. [90] This is to be distinguished from a non-hearsay use, where a witness repeats or produces a statement to prove merely that it wasmade. The classic expression of this distinction is as follows: Evidence of a statement made to a witness by a person who is not himself called as a witness may or may not be hearsay. It is hearsayand inadmissible when the object of the evidence is to establish the truth of what is contained in the statement.

It is not hearsay and isadmissible when it is proposed to establish by the evidence not the truth of the statement but the fact that it was made. (Subramanian v.

Public Prosecutor, [1956] 1 W.L.R. 965 at p. 969 (P.C.).) [91] So if a witness says that a supplier told her that it would be able to deliver supplies on date X, and if the witness’ evidence isoffered to prove that the supplier would be able to deliver supplies at that time, the evidence is hearsay and falls within the rule againstadmission of hearsay evidence. [92] In some cases, the fact that the supplier told the witness it would supply by date X, regardless of whether or not the supplier’sstatement is true, might be relevant to an issue in the proceeding and be admissible for that purpose.

For example, suppose that thewitness, in reliance on what the supplier told her, set aside time to work with the promised supplies. The witness may use the supplier’sstatement to explain why she set aside the time she did. In that case, the statement is not being used to prove that the supplier wouldsupply by date X—a hearsay purpose—but is being used for a non-hearsay purpose—it was the triggering event that caused the witnessto do something. [93] The same is true for documents, with an additional wrinkle, the requirement of authentication.

Suppose a witness produces aprintout of an email from the supplier to her stating that the supplier would supply. Absent the parties’ agreement or a specific legislativeprovision speaking to the matter, the document must by authenticated by the witness or someone else: Schwartz, above at p. 476; Evans,above at pp. 664-65; R. v. Schertzer, 2011 ONSC 579 at para. 7; David M.

Paciocco and Lee Stuesser, The Law of Evidence, 4th ed.(Toronto: Irwin Law, 2005) at p. 419; and in the case of electronic documents, see Graham Underwood and Jonathan Penner, ElectronicEvidence in Canada, loose-leaf (Toronto: Carswell, July 2015) at 13-18.2 to 13-18.4 and the Canada Evidence Act, R.S.C. 1985, c. C-5,

s. 31.1. For example, to authenticate the document, the witness could testify that she received the email and the printout is an exact copyof what she received. But after the document is authenticated, the communication is still hearsay if it is tendered to show that the supplierwould supply. [94] There can be multiple layers of hearsay. If a witness has a printout of an email on which she was not copied sent by thesupplier to one of her colleagues assuring that colleague that supplies would be delivered by date X, the document is double hearsay iftendered to prove that the supplier would supply by date X.

Someone other than the witness is reporting to the witness that the suppliertold him that it would deliver by date X. [95] When faced with hearsay objections, courts must not only appreciate the terms of the hearsay rule but should keep in mind therationales underlying it: the need for trials to be effective in discovering the truth while ensuring procedural fairness to all parties. [96] On this, the right of parties in a civil action to confront evidence presented against their positions is paramount.

Their maininstrument is cross-examination—what Wigmore has called “beyond any doubt the greatest legal engine ever invented for the discoveryof truth” and what the Supreme Court has called “a vital element of the adversarial system applied and followed in our legal system…since the earliest times,” of “essential importance in determining whether a witness is credible”: Wigmore on Evidence (Chadbourne rev.1974) vol. 5, p. 32, para. 1367; Innisfil Township v. Vespra Township, (SCC), [1981] 2 S.C.R. 145 at p. 167, 123 D.L.R.(3d) 530; R. v. Osolin, (SCC), [1993] 4 S.C.R. 595 at p. 663, 109 D.L.R. (4th) 478.

For this reason, counsel are giventhe greatest latitude in cross-examination and restrictions are rare: see, e.g., C.H.D v. C.R.H., 2007 NSCA 1, 250 N.S.R. (2d) 138 at para.41. [97] To be effective, cross-examination must be able to test many aspects of witnesses’ testimony—their observation, perception,memory and narration of events or facts, their accuracy in recounting or perceiving them, and their sincerity and honesty as witnesses. [98] All of these vital objectives are lost when witnesses testify second-hand about an event.

When that happens, only theirsincerity and honesty about what they were told can be tested. The person who actually knows first-hand about the event or fact is out ofcourt, shielded from any testing of their observation, memory, accuracy, sincerity or honesty. [99] The Supreme Court recently expressed this idea as follows: Our adversary system puts a premium on the calling of witnesses, who testify under oath or solemn affirmation, whose demeanour canbe observed by the trier of fact, and whose testimony can be tested by cross-examination. We regard this process as the optimal way oftesting testimonial evidence.

Because hearsay evidence comes in a different form, it raises particular concerns. The general exclusionaryrule is a recognition of the difficulty for a trier of fact to assess what weight, if any, is to be given to a statement made by a person whohas not been seen or heard, and who has not been subject to the test of cross-examination.

The fear is that untested hearsay evidence maybe afforded more weight than it deserves. (Khelawon, above, at para. 35.) [100] Even more recently, the Supreme Court confirmed that those who try to test hearsay evidence face “difficulties inherent intesting the reliability of the declarant’s assertion”: R. v. Baldree, 2013 SCC 35, [2013] 2 S.C.R. 520 at para. 31.

An out of court declarantmay have supplied inaccurate information but, unless in court as a witness, that possibility can never be tested: First, the declarant may have misperceived the facts to which the hearsay statement relates; second, even if correctly perceived, therelevant facts may have been wrongly remembered; third, the declarant may have narrated the relevant facts in an unintentionallymisleading manner; and finally, the declarant may have knowingly made a false assertion.

The opportunity to fully probe these potentialsources of error arises only if the declarant is present in court and subject to cross-examination. (Baldree, above at para. 32. [emphasis in original]) [101] The exclusionary rule against the admission of hearsay, however, does not stand alone. [102] Over time, the law has recognized that, in certain circumstances, it is safe for courts to rely on out-of-court statements for thetruth of their contents even though a party is unable to test the evidence by way of cross-examination. So certain exceptions to thehearsay rule have developed.

For example, a witness could report another person’s statement made against interest because of theunlikelihood of that person falsely saying something against interest. [103] Aside from those exceptions, the Supreme Court has recently developed a more general, principled exception to theexclusionary hearsay rule. Under that broader exception, courts can admit hearsay evidence if it is necessary and reliable. See, e.g., R. v.Khan, (SCC), [1990] 2 S.C.R. 531, 59 C.C.C. (3d) 92; Smith, above; R. v. B. (K.G.), (SCC), [1993] 1S.C.R. 740, 79 C.C.C. (3d) 257; R. v.

U. (F.J.), (SCC), [1995] 3 S.C.R. 764, 128 D.L.R. (4th) 121; R. v. Blackman, 2008SCC 37, [2008] 2 S.C.R. 298. (

b) Applying the evidentiary principles to this case [104] No current or former Alembic employees testified at trial. Teva did not adduce any direct evidence from Alembic. Instead, Tevarelied upon the testimony of Mr. Major. [105] At all material times, Mr. Major was the vice-president for development management and regulatory affairs and a member ofthe executive management committee with Ratiopharm (Teva). A fair reading of the Federal Court’s reasons is that the Federal Courtwas satisfied that Mr.

Major, acting in that capacity, would have had first-hand knowledge of the corporate wishes and objectives ofRatiopharm (Teva), the steps it took to achieve those objectives, commercial arrangements Ratiopharm (Teva) had made, and the state ofthe market (i.e., evidence of the sort described in the transcript at pages 475-478 of the Appeal Book). As part of this, a venlafaxinesupply agreement between Ratiopharm (Teva) and Alembic and another related agreement were placed before the Court: see Appeal

Book at pp. 462-463. No objection was taken to this. [ 106 ] The Federal Court took some of Mr. Major’s testimony as showing that Ratiopharm (Teva) had the corporate objective of securing adequate supply of venlafaxine from Alembic, manifested that objective by making inquiries and sending documents to Alembic regarding the supply of venlafaxine should the need arise, and assured Alembic that it would redirect equipment to Alembic should the need arise at a particular time.

The Federal Court considered that sort of evidence admissible on the issue of Ratiopharm (Teva)’s general intentions in the hypothetical world and evidence of the general steps it took to prepare itself for entry into the market. In this respect, the Federal Court did not err. In the words of the Federal Court during the hearing, “He does have the expertise having been employed there for a number of years to say, this is what we [Ratiopharm (Teva)] would have done [in the hypothetical world] or this is what I believe we would have done” : see Appeal Book, p. 487. [ 107 ] Similarly, by virtue of his position, Mr.

Major had first-hand knowledge of the general relationship between Ratiopharm (Teva) and Alembic. He testified that the relationship was a warm, long-trusted one: see Appeal Book, p. 479. [ 108 ] The Federal Court also properly admitted another category of evidence from Mr. Major. In 2004, over a year before the relevant supply times in the hypothetical world, Mr. Major visited Alembic’s manufacturing facility in Gujarat, India for two weeks.

From this visit, he developed the view that Alembic was eager to please Ratiopharm (Teva) and was keen to do what it could to satisfy Ratiopharm (Teva)’s need for venlafaxine as it arose. Based on his visit, Mr. Major testified at trial about the capacity of Alembic’s manufacturing facility and Alembic’s desire to supply venlafaxine to Canada. It was open to the Federal Court judge on this record to admit the evidence of what Mr. Major saw and the conclusions he drew from his observations; however, any reports made to Mr.

Major by Alembic personnel during his visit could not be used as evidence of the truth of those reports, as that would be a hearsay use. [ 109 ] In his testimony, Mr. Major could not supply evidence based on direct, first-hand knowledge or observation of at least the following: the operating capacity of Alembic’s facility during the relevant time, Alembic’s actual ability and willingness to redirect or add equipment at the relevant time, and how long production at Alembic would have taken at the relevant time.

Yet there is admissible evidence or evidence that was not objected to in the record that might conceivably bear on these matters, such as the venlafaxine supply agreement, Alembic’s production of venlafaxine at other times, and Mr. Major’s impressions, observations and conclusions he drew from his visit to Alembic’s manufacturing facility.

The inferences that could permissibly be drawn from the admissible evidence, in conjunction with other admissible evidence about Alembic’s ability to supply venlafaxine at the relevant time, is a question I shall return to later in these reasons. [ 110 ] During the course of his testimony, Mr. Major was presented with emails and documents, such as a spreadsheet setting out Teva’s marketing forecast and associated documents, and was asked to comment on them: see Appeal Book, pp. 466-467. Many spoke to Alembic’s capacity to produce in the abstract. He neither authored nor received many of the emails and documents.

In fact, out of all of the emails, he authored only one—a meeting request—that the Federal Court did not cite in its reasons. The other emails contained particular statements made by various employees of Alembic and Ratiopharm (Teva) and the documents were prepared by others or by persons unknown. Mr.

Major was not in a position to authenticate emails or documents that he neither received nor sent. [ 111 ] At the outset, counsel for Pfizer raised an objection stating that “[w]e haven’t admitted these documents” and added, in the case of the first document, that “I haven’t heard my friend properly identify it through this witness, other than through hearsay.” He warned that he would be “standing up for a few of these documents.” See Appeal Book, p. 465.

I construe the objection as a warning that if Teva sought to have the documents admitted as evidence, it would have to authenticate them. [ 112 ] Teva submits that Mr. Major could use the emails and documents to refresh his memory. I accept that if Mr. Major had some first-hand memory of matters responsive to questions posed to him, he could use unauthenticated emails and documents to refresh his memory, even if those emails and documents were themselves inadmissible: R. v. Fliss , 2002 SCC 16 , [2002] 1 S.C.R. 535 at paras. 60- 68 .

For example, the spreadsheet setting out Teva’s marketing forecast, prepared by persons other than Mr. Major and an unauthenticated document, is not admissible through Mr. Major. But Mr. Major’s knowledge of Ratiopharm (Teva)’s marketing expectations, if first-hand, is something to which Mr. Major can testify given his role (see paras. 105-108, above) and he was free to refresh his memory using this spreadsheet. But on the issue of Alembic’s production capacity, his first-hand knowledge was limited to what he saw on his visit to Alembic’s manufacturing facility in 2004. [ 113 ] At one point, Mr.

Major was asked whether Mr. Woloschuk, Ratiopharm (Teva)’s Vice-President for Business Development, reported to him about Alembic’s capacity to supply venlafaxine: see Appeal Book, p. 495. Pfizer objected to the question on the basis Teva was seeking to elicit hearsay evidence. If the evidence were offered as truth of Alembic’s actual capacity to supply, it was. Pfizer registered similarly meritorious hearsay objections to Tabs 12-15 and 21 in the book of documents put before Mr.

Major, some of which the Federal Court relied upon: Appeal Book, p. 496. [ 114 ] Teva submits that it was not using some of the emails for the truth of their contents. It said that at best they were just corroboration of Mr. Major’s testimony as to his personal knowledge of the production capacity of Alembic.

But hearsay they were: whether being used as primary evidence or corroborative evidence, these emails recounting the statements of others—sometimes recounting the recounting of statements of others—were tendered for the purpose of proving what Alembic would and could have done in the hypothetical world, not just to prove the fact that they were made. And corroborative evidence must itself be evidence that is admissible: Khelawon , above at para. 100 . There is no “corroborative evidence” exception to hearsay. [ 115 ] Teva also suggests that statements in emails written to and from personnel in Mr.

Major’s department or area could be admitted as truth of their contents through Mr. Major. As discussed above, Mr. Major, by virtue of his position, could be found—as the Federal Court found— to have first-hand knowledge of the corporate wishes and objectives of Ratiopharm (Teva), how it went about achieving those objectives, and Ratiopharm (Teva)’s willingness to redirect equipment to Alembic. But he does not have first-hand knowledge of the truth of particular statements made by employees in emails they write to each other.

Tendering particular statements in emails between employees in Ratiopharm (Teva) through a separate witness, such as Mr. Major, to prove the truth of the statements is a hearsay use. There is no “department head” exception to hearsay whereby specific statements in emails passing between underlings in the department can be admitted through the department head for the truth of their contents.

[116] In this case, the Federal Court explicitly relied upon some of these inadmissible emails to support its conclusions about whatwould have transpired in the hypothetical world: an email from Kavit Tyagi of Alembic, to Jim Mihail, a product manager withRatiopharm (Teva)’s marketing group (at para. 154), an email exchange between Alembic and Bob Woloschuk, Ratiopharm (Teva)’sVice-President for Business Development that reported that Alembic was only operating at 40 per cent capacity and that it was planningto expand its manufacturing plant to “double its capacity to handle at least 2 billion capsules” (at para. 156), and an email exchangebetween Ratiopharm (Teva) representatives and Alembic that said that had Ratiopharm (Teva) not called off production in October 2005,Alembic would have produced 6.6 million capsules by December 2005 (at para. 157).

In each case, the emails are unauthenticated andare statements of others, not Mr. Major, reporting on statements made by others at Alembic. They are at least double hearsay on the issueof what Alembic could have or would have done. And depending on whether the people at Alembic had first-hand knowledge of thematters they were describing, they might be triple hearsay or even more. [117] Teva also invokes the state of mind exception to hearsay in support of the admissibility of emails where Alembic employeesexpressed a willingness or optimism about the supply of venlafaxine in the required quantities when required.

It is true that an out-of-court declarant’s statement tendered to show the declarant’s state of mind or intention is admissible: Brisco Estate v. Canadian PremierLife Insurance Company, 2012 ONCA 854, 113 OR (3d) 161, citing Smith and Starr, both above. However, the emails Mr. Majorreferred to in his testimony—communications from colleagues about what Alembic employees said—are double hearsay: even if thestate of mind exception applies, the emails remain a hearsay report by an out-of-court declarant and the emails remain unauthenticated.

Afurther problem is that the state of mind of an Alembic employee is not necessarily the state of mind of Alembic, the corporate entity:Canadian Dredge & Dock Co. v. The Queen, (SCC), [1985] 1 S.C.R. 662, 19 D.L.R. (4th) 314; Rhône (The) v.Peter A.B. Widener (The), (SCC), [1993] 1 S.C.R. 497, 101 D.L.R. (4th) 188. So proof of the employee’s state of mindmay be irrelevant to the issue of Alembic’s state of mind and inadmissible on that basis.

Finally, as Brisco Estate shows, the evidencegoes no higher than what the employee believed or wished at that time: an inference must be drawn to extend that belief into a differenttime and that may not be possible. On this, again, the issue of when inferences are permissible from evidence is discussed below. [118] In both this Court and the Federal Court, Teva did not provide evidence or submissions to the effect that the hearsay evidencenevertheless was admissible because it was reliable or necessary. Nor could it: • Necessity. Many of the emails Mr.

Major testified about disclose the names of many Alembic employees who might havebeen able to give direct testimony on Alembic’s ability to supply during the relevant time. Those emails also disclose the names ofpersonnel at Ratiopharm (Teva) who also could have been called. Teva offered no evidence or submissions as to why these individualsor others could not be called to testify. Instead, Teva called Mr. Major, who had no direct, first-hand knowledge of Alembic or itsoperations at the relevant time. • Reliability. The hearsay evidence tendered by Mr.

Major did not possess circumstantial guarantees of trustworthiness.Quite the contrary. Ratiopharm (Teva) was Alembic’s client and one may presume that Alembic had an incentive to say whateverneeded to be said to keep its customer pleased and give it the impression that it could satisfy its customer’s needs at any time it asked. [119] All of the mischief associated with admitting hearsay evidence is present in this case. Confronted with the hearsay evidence, allthat Pfizer could do was test Mr.

Major’s sincerity and honesty about what he was reading from documents he did not author, what hehad heard from Alembic personnel, and what colleagues were saying Alembic personnel were saying.

In a high-stakes case such as this,that was hardly any sort of meaningful or fair test. [120] Those who actually knew first-hand about whether Alembic could supply the desired quantities of venlafaxine at the relevanttimes in the hypothetical world—personnel at Alembic—were out of court, shielded from any testing of their observation, memory,accuracy, sincerity or honesty, but their say-so on that issue—recounted or recorded by others—was admitted into these proceedings.This worked great unfairness to Pfizer. [121] Pfizer frequently objected to the admissibility of hearsay evidence.

It was largely right to do so: in my view, every hearsayobjection it made during Mr. Major’s testimony was correct, except on the subject-matters discussed at paras. 105-108 and 112, above.But on a number of occasions, the Federal Court said that it would consider the weight of the evidence or it said that Pfizer’s objectionwas one of weight, not admissibility. On one occasion, it said that because Mr. Major’s name did not appear on a document, thedocument would “probably just go to weight.” The Federal Court admitted this evidence when it should have been excluded.

This was anerror that might have affected the outcome of the case. Therefore, the Federal Court’s judgment must be set aside.

(3) The issue whether there was palpable and overriding error on a factualfinding [122] Pfizer attacks one of the bases upon which the Federal Court found that Ratiopharm (Teva) could have supplied its product inthe hypothetical world. [123] At one point in its reasons, the Federal Court considered (at para. 152) whether any “bottleneck” in Alembic’s manufacture ofRatiopharm (Teva)’s venlafaxine product in the hypothetical world would have come at the stage of encapsulation.

In finding that nobottleneck would have taken place at that stage, the Federal Court relied in part on the fact that Alembic had many fluid bed processors.But, as Pfizer notes, fluid bed processors are not used for encapsulation. Teva does not disagree. [124] However, Teva suggests that any error by the Federal Court here was inconsequential, not overriding, and so it does not vitiatethe Federal Court’s judgment. Based on this Court’s decision in South Yukon, above at paragraph 46, I agree: “Overriding” means an error that goes to the very core of the outcome of the case.

When arguing palpable and overriding error, it is notenough to pull at leaves and branches and leave the tree standing. The entire tree must fall. [125] In the course of its reasons on this point (at para. 152), the Federal Court also accepted and relied upon Mr. Major’s non-

hearsay testimony that if necessary, his then-employer, Ratiopharm (Teva), would have “bought equipment, put equipment in place” to avoid any bottleneck. Thus, to the extent the Federal Court misunderstood the use of fluid bed processors, I am not persuaded that its overall finding was vitiated by palpable and overriding error.

(4) Other

section 8 damages issues [ 126 ] Pfizer submits that the Federal Court erred in selecting January 10, 2006 as the start of the period of loss, or, in other words, the time when Ratiopharm (Teva) would have been legally able to start selling its venlafaxine product in the market. [ 127 ] It submits that in the hypothetical world, Ratiopharm (Teva) would not have received a notice of compliance allowing it to sell its venlafaxine product before February 13, 2006.

It says that when the ’778 Patent was listed on the patent register, Ratiopharm (Teva) would have had to serve a notice of allegation addressing it and the Minister would then be prohibited from issuing a notice of compliance until 45 days had passed: see PMNOC Regulations , para. 7(1)( d ). [ 128 ] The Federal Court selected January 10, 2006, the expiry of the ’540 Patent as the start date.

This was the soonest Ratiopharm (Teva) could have marketed its venlafaxine product given that the Minister had certified that, but for the PMNOC Regulations , it would have given Ratiopharm (Teva) its notice of compliance on December 7, 2005. [ 129 ] In my view, the Federal Court committed no error in principle in setting January 10, 2006 as the start date. [ 130 ] In essence, Pfizer’s submission is that in the hypothetical world the PMNOC Regulations should not be disregarded for the purpose of determining the start of Ratiopharm (Teva)’s period of loss. [ 131 ] This submission runs counter to the express wording of paragraph 8(1)(

a) of the PMNOC Regulations . That paragraph provides that the

section 8 liability period begins “on the date, as certified by the Minister, on which a notice of compliance would have been issued in the absence of these Regulations unless the court concludes [under subparagraph 8(1)( a )(ii)] that … a date other than the certified date is more appropriate” [my emphasis]. Thus, it is only in circumstances where, under subparagraph 8(1)( a )(ii), the Court deems that another date is more appropriate that this default date can be set aside. [ 132 ] Pfizer’s submission is also precisely the opposite of what a majority of this Court held in Apotex Inc. v.

Sanofi-Aventis , 2014 FCA 68 , 125 C.P.R. (4th) 403 at paragraph 170 ( Apotex Ramipril s. 8 FCA ): “the [ PMNOC Regulations ] are to be disregarded in determining the beginning of the

section 8 liability period.” On appeal, the Supreme Court of Canada affirmed those reasons: Sanofi- Aventis v. Apotex Inc. , 2015 SCC 20 , [2015] 2 S.C.R. 136. [ 133 ] Pfizer’s submission is also contrary to the holding of a majority of this Court in Teva Canada Limited v. Sanofi-Aventis Canada Inc. , 2014 FCA 67 , 126 C.P.R. (4th) 1 at paragraph 145 ( Teva Ramipril s. 8 FCA ): [145] My view, in

summary, is that in the hypothetical world constructed for the purposes of determining

section 8 damages, the NOC Regulations should not be assumed away except to the extent required by paragraph 8(1)( a ), that is, for the purpose of determining the beginning of the

section 8 liability period .

For all other purposes, the NOC Regulations should be assumed to exist in the hypothetical world, and all steps that were actually taken under the NOC Regulations should be assumed to have been taken in the hypothetical world unless there is evidence upon which the trier of fact may reasonably conclude that different steps would have been taken. [my emphasis] [ 134 ] Pfizer also takes issue with the Federal Court’s conclusions concerning the entry and participation of Ratiopharm (Teva)’s generic competitors in the venlafaxine market in the hypothetical world. [ 135 ] In the Federal Court, Pfizer submitted that Teva’s damages claim would be reduced because in the hypothetical world Novopharm and Pharmascience would have entered into the market, cutting down Ratiopharm (Teva)’s market share. [ 136 ] In dealing with this submission, the Federal Court did not have the benefit of Apotex Ramipril s. 8 FCA .

In that case, this Court held that the regulatory barriers to entry, including the PMNOC Regulations , which all generic manufacturers face in the real world, also affect all generic manufacturers in the hypothetical world.

Thus, in order to assess whether and when other generic manufacturers could have and would have entered the market in the hypothetical world, the Federal Court had to assess, among other things, whether regulatory barriers stood in their way. [ 137 ] Although the Federal Court did not have the benefit of Apotex Ramipril s. 8 FCA , it applied principles consistent with it and committed no error in principle. It proceeded on the basis that other generic manufacturers entering the market would have had to follow the PMNOC Regulations .

It considered all of the evidence, in part guided by real world events and based on the evidence before it, to determine whether “any other generics would have entered the market during the Relevant Period” and, if so, when (at para. 89). [ 138 ] This was precisely in accordance with Apotex Ramipril s. 8 FCA . At paragraph 159 of Apotex Ramipril s. 8 FCA , the majority of this Court (whose reasons were adopted on appeal by the Supreme Court) agreed with the methodology the Federal Court adopted in that case. It described the methodology as follows (at para. 158): [I]n the hypothetical world, the competitors of a

section 8 damages claimant are bound by the [ PMNOC ] Regulations , and…[they must be taken to] act as they did in the real world in relation to the [ PMNOC ] Regulations except to the extent that there is evidence upon which the trier of fact can reasonably conclude that they would have acted differently. And a few paragraphs later, the majority confirmed the state of the law on this point (at para. 162): It follows that in the hypothetical market, the behaviour of competing generic drug manufacturers must be determined on the basis that the [ PMNOC ] Regulations exist, and each generic drug manufacturer will conduct itself accordingly.

[139] On the evidence, the Federal Court found (at para. 94) that in the hypothetical world Novopharm would have received a noticeof compliance shortly after Ratiopharm (Teva). Novopharm had entered into an agreement with Wyeth (Pfizer). Under this agreement,Novopharm could obtain a notice of compliance and take steps to obtain listing on formularies soon after Ratiopharm (Teva) could. Butit noted (at para. 111) that Novopharm faced problems in manufacturing venlafaxine.

Considering the evidence before it, it found (atpara. 129) that “Novopharm would have entered the market with Novo-Venlafaxine on December 1, 2006 in the [hypothetical] world, asit did in the real world.” [140] In the case of Pharmascience, the main question for the Federal Court was whether it would have served a notice of allegationin the hypothetical world. The Federal Court answered this in the negative (at para. 132). Pharmascience intended to time the launch ofits product to coincide with a decision on the ’778 Patent in favour of Ratiopharm (Teva).

It was adverse to litigation and would not actsooner (at para. 141). Therefore, the Federal Court concluded that Pharmascience would not have been ready to launch earlier than it didin the real world. [141] Pfizer submits that in assessing what Pharmascience would have done in the hypothetical world, the Federal Court failed tosufficiently take into account real world events. In my view, this is a complaint about how the Federal Court weighed the evidence. Butappellate courts are not entitled to interfere based on their own weighing of the evidence short of palpable and overriding error: Housen,above.

In my view, the record shows real world evidence of an intention on the part of Pharmascience to delay or avoid litigationconcerning the ’778 Patent. [142] Overall, in its analysis on this point, the Federal Court did not err in principle. And, in applying the principles to the evidencebefore it, it did not commit any palpable and overriding error. [143] Pfizer also says that the Federal Court erred during its calculation of damages by attributing Novopharm’s market share toRatiopharm (Teva) without also attributing Novopharm’s rebates to Ratiopharm (Teva). Pfizer also advanced this submission below.

TheFederal Court dealt with it (at various places in paras. 209-227) by considering and weighing the evidence of a number of witnesses andconsidering what weight should be given to Novopharm’s sole-source and multi-source trade spend rates in determining Ratiopharm(Teva)’s sole-source and multi-source trade spend rates in the hypothetical world. On this issue it also preferred the testimony of Teva’sexpert and made an adverse credibility finding against Pfizer’s expert (at para. 38). Pfizer has not persuaded me that there is any palpableand overriding error in the Federal Court’s analysis on this point.

(5) Pre-judgment interest [144] On the issue of pre-judgment interest, the parties dispute the date the cause of action arose. Pfizer submits that the cause ofaction arose on August 1, 2007 when this Court dismissed Wyeth (Pfizer)’s prohibition application. At that point, the requirements for aclaim under

section 8 of the PMNOC Regulations were met. [145] The Federal Court disagreed with Pfizer. In its view, the cause of action arises on the date that the damages that are the basis forthe claim actually begin to be suffered. Here that was January 10, 2006. It rejected Pfizer’s submission that the dismissal of theprohibition application is the relevant start date. It offered the following basis (at para. 258), with which I agree: The disposition of a Prohibition Application does not ground liability, it simply confirms that liability exists.

The cause of action ariseson the date that damages that are the basis for the claim begin to be suffered. Typically, this will coincide with when the Relevant Periodbegins, as it did in Pantoprazole FC 2012 [Apotex Inc v. Takeda Canada Inc., 2013 FC 1237, 123 C.P.R. (4th) 261] and as it does in thiscase. However, because the Relevant Period may begin before damage is actually suffered, this need not always be the case.

For thatreason, prejudgment interest must be tied to when the loss actually begins to be suffered irrespective of whether that date is the same asthe start of the Relevant Period. [146] On two occasions, the Federal Court has found that the cause of action under

section 8 arises on the patent hold date becausethat is when the period of liability commences: Apotex Inc. v. Takeda Canada Inc., 2013 FC 1237, 123 C.P.R. (4th) 261 at paras. 173-174; Sanofi-Aventis Canada v. Teva Canada, 2012 FC 552, 410 F.T.R. 1 at paras. 297-299. [147]

Section 8 damages—damages suffered during the period when a notice of compliance could have been issued but was not byreason of the automatic stay—are analogous to an undertaking to the court to pay damages in the event a successful applicant for aninterlocutory injunction should ultimately fail at trial: Apotex Inc. v. AstraZeneca Canada Inc., 2012 FC 559, 410 F.T.R. 168 at para. 58,aff’d 2013 FCA 77, 444 N.R. 254; Apotex Inc. v. Merck & Co. Inc., 2009 FCA 187, [2010] 2 F.C.R. 389 at para. 48.

This Court has heldthat pre-judgment interest on an undertaking in damages runs from the date an interlocutory injunction is granted, not from the day it isset aside, because that is when the damages start to arise: Algonquin Mercantile Corp. v.

Dart Industries Canada Ltd., (FCA), [1988] 2 F.C. 305, 16 C.P.R. (3d) 193 at para. 27 (C.A.). [148] Pfizer also challenges the Federal Court’s decision to calculate pre-judgment interest from the beginning of each month on theentire amount of Teva’s lost profits in that month, rather than at the end of each month. [149] In this case, the Federal Court followed the calculation of pre-judgment interest in subsection 128(3) of the Courts of JusticeAct, R.S.O. 1990, c. C.43 as it was bound to do: Federal Courts Act, R.S.C. 1985, c. F-7, ss. 36(1).

It applied the principles set out by theCourt of Appeal for Ontario in Celanese Canada Inc. v. Canadian National Railway Co. (2005), (ON CA), 196O.A.C. 60, 138 A.C.W.S. (3d) 23 at para. 17: The purpose of s. 128(3) is to achieve fairness in the payment of the prejudgment interest on pecuniary damages by ensuring that aplaintiff will not recover a windfall that would otherwise result were s. 128(1) to be applied.

It does so by providing a formula for theaccrual of interest on pecuniary damages as they are incurred, in lieu of requiring the court to conduct a series of individual calculations.Section 128(3) accords with the underlying compensatory principle for awarding prejudgment interest, which is to compensate a partyfor the loss of the use of its money.

[150] The Federal Court also noted that an award of interest is meant to compensate rather than punish: Bank of America Canada v.Mutual Trust Co, 2002 SCC 43, [2002] 2 S.C.R. 601. [151] It also adopted the statement in Chandran v. National Bank, 2011 ONSC 4369, 95 C.C.E.L. (3d) 322 at para. 8, aff’d 2012ONCA 205, 99 C.C.E.L. (3d) 277 on a different point, that “[i]nterest is due for a month as soon as the payment is owed, not after thepayment has been outstanding for a month”: see also Lowndes v.

Summit Ford Sales Ltd. (2006), (ON CA), 206 O.A.C.55, 47 C.C.E.L. (3d) 198. [152] In the circumstances of this case, I see no legal error in the Federal Court’s approach, nor any palpable and overriding error thatwould vitiate its decision. The award of interest is a discretionary matter: Courts of Justice Act, above, s. 130. There is no principle of lawre

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