Collaboration of Counsel in Preparing Expert Reports

dTechs EPM Ltd v British Columbia Hydro and Power Authority 2023 FCA 115 Gauthier JA: Mactavish, Leblanc JJA varg 2021 FC 190 Fothergill J

2,549,087 / Electrical Theft Detection System

Gauthier JA’s decision for the FCA in dTechs involves “the application of known principles to a very unusual set of facts” [7]. While it did not set out new law, the unusual facts provided an opportunity for a helpful discussion of the principles and procedure related to the introduction of new evidence on appeal [20]–[30], and the proper role of counsel in preparing expert reports [32]–[37]. There is also a helpful nugget on claim construction.

The patentee, dTechs, lost comprehensively at trial: see here. During the costs assessment, dTechs obtained invoices and working agreements relating to BC Hydro’s expert witness, Mr. Shepherd, which led dTechs to believe that Shepherd did not author his reports. dTechs formed the view that the reports had instead been ghostwritten by a Mr Falany, the President of the corporation which provided Shepherd’s services [41]. There was also some suggestion that first drafts of the reports may have been written by counsel for BC Hydro [45]. dTechs consequently argued that the trial decision was unreliable as it was based on tainted evidence.

A motion to allow these documents to be introduced as new evidence on appeal was granted by a motion judge. Gauthier JA’s extensive discussion on the law and practice relating to the role of the motion judge on such a question [20–[30] will be essential reading for anyone pursuing a similar motion in the future.

Gauthier JA then went on to address the role of counsel in the preparation of expert reports. She noted that “In patent cases, it is not unusual for expert reports to be prepared in close collaboration with counsel in an effort to present the substantive opinion of the expert in a manner and format that is helpful to the Court in light of the complexity of the issues raised” [32], and “[a]s a practical matter, it is known that extensive notes are taken during meetings with experts to help prepare the draft reports, and that counsel are actively involved in putting these reports together” [33]. However, “[t]his does not inevitably mean that those drafts do not reflect the substantive and objective opinion expressed by the expert during those meetings.” A “high level of instruction by lawyers to expert witnesses” is not necessarily objectionable in patent cases [53]. While there are limits to the involvement of counsel, the important point is not who puts the words to paper: “I know of no cases where an expert report was excluded in a patent case on the sole ground that the first draft of said report was penned by counsel after meetings with the expert to discuss their opinions in detail” [34]. The key point is that “the Court must ultimately be presented with the substantive and objective opinion of the expert” [34].

Gauthier JA also noted that any potential overstepping of the proper limits on the role of counsel will normally be revealed on cross-examination at trial, and that is the appropriate place to raise such objections, so that it may be considered by the trial court in assessing the evidence [34]–[35]. The FCA will not be sympathetic to parties trying to raise this kind of argument on appeal [37].

Further, the degree of involvement of counsel will go to weight rather than admissibility, unless it is established that the expert “is unable or unwilling to comply with the duty to give fair, objective and non-partisan opinion evidence” [49]. Consequently, “[t]he Federal Court could not conclude that there was a reasonable basis for refusing to admit Mr. Shepherd’s expert evidence simply because the first drafts of his reports were penned by counsel after many hours of consultation with him” [55]. However, the fact that Shepherd might not have drafted the reports himself might have affected the weight that the trial court would have given to his evidence [56].

The weight to be given to the evidence is a matter for the trial court, not the FCA [56], but even so, the fact that the new evidence might have affected the weight to be given Shepherd’s reports was not in itself sufficient to require sending the matter back for redetermination [57]. There is a second question, whether the trial conclusions would remain unchanged, taking the view most favourable to dTechs. Gauthier JA therefore considered whether “based on the other evidence adduced at trial, the distinct findings and conclusions of the Federal Court would remain unchanged, such that the outcome of the trial would not be affected” [57], even if no weight were given to Shepherd’s evidence [58].

Gauthier JA therefore turned to the question of whether the result would have been the same without Shepherd’s evidence. This required a detailed look at the construction of the claims. While most of the discussion turned on the facts and evidence, Gauthier JA made some more general points.

The most basic point is that claim construction is ultimately a matter of law [68]. “[T]he role of the expert is not to interpret the patent claims per se, ‘but to put the trial judge in the position of being able to do so in a knowledgeable way’” [69], primarily by providing evidence to the court as to the meaning of technical terms. Conversely, this means that the interpretation of non-technical terms, or a fortiori, legal terms of art, are for the court, not for experts. This point arose in considering the term “further comprising”. After hearing evidence on this point, the trial judge had remarked that “certainly claim construction is a matter for the Court, and I’m not sure that terms like ‘further’ or ‘wherein’ require the input of an expert witness” [78]. Gauthier JA affirmed that “I fully agree with the trial judge that if the words ‘further comprising’ are terms of the art, it is in the art of claim drafting, one that none of the experts were qualified to opine on, and in respect of which the judge did not require expert guidance” [80].

On the facts, Gauthier JA concluded that giving Shepherd’s evidence no weight could not have impacted the holding that the 087 patent was not infringed, but it might have affected the validity of one claim (Claim 4), which had been attacked by way of counterclaim. The appeal on infringement was therefore dismissed, but the appeal on validity was allowed in part, amending the judgment to the extent that Claim 4 is not declared to be invalid [118]–[120]. The defendants are entitled to a retrial on the validity of Claim 4, if they so chose.

Can Fact Witnesses Provide Evidence on the “But For” World?

Eli Lilly Canada Inc v Teva Canada Ltd 2017 FC 88 O’Reilly J
            2,041,113 / olanzapine / ZYPREXA

In this s 8 NOC case, Teva is seeking damages from Lilly as compensation for having been prevented from coming to market with a generic version of olanzapine.* O’Reilly J’s decision did not arrive at a final quantum, but simply made the factual findings necessary for those calculations [6]. Most of the issues—when would Teva’s product have been listed, what would its market share have been, how much trade-spend—turned on the particular facts. The issue of most interest and general importance was an evidentiary question as to the admissibility of opinion evidence proffered by a fact witness. O’Reilly J also clarified a point regarding pipefill.

Opinion evidence proffered by fact witness
In order to assess damages, it is necessary to determine what would have happened in the “but for” world. That is necessarily a hypothetical matter. Teva wanted its fact witness to testify as to what they would have done or what would have happened in the but-for world [14], for example whether Teva would have launched with material produced by Process 1 or Process 2 [15]. The idea was evidently that the Teva executives who were actually responsible for making those types of decisions, and who would have made the decision in question had the statutory stay not been triggered, were best placed to address that aspect of what would have happened in the but for world. Lilly objected on the basis that the opinions of fact witnesses are not admissible, and O’Reilly J agreed [13].

O’Reilly J did not cite any authority for this proposition. While I’m not an expert on evidence law, I’m not sure that there is a rule prohibiting fact witnesses from giving opinion evidence. The issue is discussed at length in Graat v. The Queen, [1982] 2 SCR 819, in which Dickson J, for the Court, concluded (836):

Except for the sake of convenience there is little, if any, virtue, in any distinction resting on the tenuous, and frequently false, antithesis between fact and opinion. The line between “fact” and “opinion” is not clear.

He then says that the question at issue should be resolved on the basis of general principles:

Admissibility is determined, first, by asking whether the evidence sought to be admitted is relevant. This is a matter of applying logic and experience to the circumstances of the particular case. The question which must then be asked is whether, though probative, the evidence must be excluded by a clear ground of policy or of law.

Ultimately, the SCC held that the witnesses in question “had an opportunity for personal observation. They were in a position to give the Court real help” (836). Consequently the evidence was admissible. Without more details than are evident from the decision, I don't know how those principles would have applied to the evidence in question in this case, but it seems to me at least arguable that it would have been admitted.

O’Reilly J noted that there was a way around the problem:

[13] During the trial, I suggested to counsel that the best way to provide the relevant evidence to the Court would be to explore with fact witnesses what they did in the real world. The witnesses could then be asked whether they knew of any reason why they would have acted differently in the but-for world. This would confine fact witnesses to their own knowledge and experience, as opposed to asking them, in an open-ended fashion, what they would have done or what they thought would have happened in the but-for world.

While this would be a getting a way around the putative rule against allowing fact witnesses to give opinion evidence, the point of Graat, as I read it, is that these kind of indirect methods are not necessary.

The specific issue in Graat, and many of the cases discussed therein, was whether lay witnesses, such as police officers, could testify as to whether the accused’s ability to drive was impaired by alcohol. As many of the decisions emphasized, this is a situation where an ordinary person who has actually observed the accused has sufficient experience to form a helpful opinion. In a passage adopted by Dickson J at 839, Lord MacDermott in Sherrard v Jacob [1965] NILR 151, 162, stated:

The driving of motor vehicles is now so much a matter of everyday experience for ordinary people that I find it difficult to see how inferential or opinion evidence as to being (a) under the influence of drink and (b) thereby unfit to drive a car can be placed in different categories for the purpose of determining admissibility. The one as much as the other seems to be within the capacity of the non-expert to form a reasonable conclusion

While drunken driving might seem far removed from pharmaceutical production processes, the parallel seems to me to be close nonetheless. Whether a pharmaceutical company might have used one process or another is not a matter of everyday experience for ordinary people, but, as I understand the facts, it was a matter of everyday experience for the particular fact witnesses in this case. The point from Graat is that whether or not he had been qualified as an expert, the witnesses in question had sufficient relevant knowledge and experience to provide helpful evidence on the issue at hand.

A broad reading of Graat is that opinion evidence is admissible if it would be helpful and there is no clear ground of policy or of law for excluding it (835-36). A narrower reading is that fact witnesses may give opinion evidence when that is a method of making a compendious statement of facts (840). Even on the narrow reading, it seems to me that there is a good argument that the evidence at issue in this case would be admissible (again with the caveat that it is not possible to take a firm view with the limited details in the opinion). In some decisions reviewed by Dickson J, the court had taken a position very similar to that implicit in O’Reilly J’s suggestion, to the effect that the fact witness could state all the factual circumstances which would lead her to form the opinion that the accused was intoxicated, but the witness could not state the opinion itself (828). This position was clearly rejected by the SCC in Graat. As I understand, the point of allowing the opinion evidence is largely that such stratagems are unnecessary.

I don’t want to say that the evidence at issue in this case should have been admitted, as the nature of the evidence was described only in general terms. And, again, I am not an expect in evidence law, so there may well be a rule or development that I have missed. But, at least on the authority of Graat, it seems to me that there is no strict rule prohibiting fact witnesses from giving opinion evidence.

Pipefill
Teva claimed that its losses should include an amount for pipefill— “that is, the quantity of sales Teva would have made to distributors in the but-for world, an amount that would not be captured by retail sales figures” [90]. The idea is that the manufacturer ships its product from the factory, it sits a while with the wholesaler until ordered by the retailer, and sits a while with the pharmacy before being dispensed to an individual [93]. Teva wanted its lost profits to include losses on product that had left the factory, but had not yet been dispensed. O’Reilly J held that Teva was not entitled to lost profits on pipefill [103]. The basic rule for s 8 damages is that “but for” causation, in a world in which the patentee had not applied for an order of prohibition, except that losses made after the compensable period are not compensable, even if they were caused by the statutory stay: 2009 FCA 187, [92]-[102]; 2011 FCA 149. This is a statutory exception to the general principle that losses caused by the wrong are recoverable. O’Reilly J observed that pipefill product is actually sold, but it is sold outside of the compensable period [92]. Consequently, it is not a recoverable loss. This holding is significant because there are several other cases, reviewed in detail by O’Reilly J [96]-[101], which arguably did allow pipefill. He held that these cases were not determinative. In some the holding was ambiguous, and “In none of them was the issue seriously contested or a quantum specifically calculated” [101]. To the extent they differed, he therefore declined to follow them [103]. Given that O’Reilly J gave full consideration to the point, his holding is likely to be influential.

*The procedural history is long. Hughes J ruled against Lilly in 2007 FC 596, the NOC proceeding that ultimately gave rise to this s 8 action [4]. After Novopharm (now Teva) launched, O’Reilly J held the patent invalid Olanzapine (No 1) 2009 FC 1018 which was reversed and remanded by 2010 FCA 197. On remand, in was Olanzapine (No 2) 2011 FC 1288, O’Reilly J again concluded the patent was invalid and this was affirmed 2012 FCA 232 [2] (blogged here).

Broad Experimental Use Exception to Anticipation

Bayer Inc v Apotex Inc 2016 FC 1013 Fothergill J
            2,382,426 / micronized drospirenone / YAZ YASMIN / action

Bayer’s ‘426 patent covers an oral contraceptive comprising drospirenone and ethinylestradiol, where the drospirenone is in the form of fast dissolving particles. In this consolidated infringement action, Fothergill J found claims 31, 48 and 49 to be valid and infringed by Apotex’s Zamine and Mya tablets and Cobalt’s Zarah tablets. The conclusions on validity and infringement turned on almost entirely the facts. With that said, it is significant that that Fothergill J accepted the broad experimental use exception to anticipation set out by Hughes J in his NOC decision concerning the same patent. Fothergill J’s remarks on blinding of expert witnesses, as well as on comity and the binding effect of prior FCA decisions on claim construction, are also of interest. This post deals with experimental use and blinding, while tomorrow’s post will deal with comity.

More than one year before the filing date, Schering, Bayer’s predecessor in title [19], conducted Phase III clinical studies in Europe and the United States involving oral contraceptive tablets containing the claimed amounts of drospirenone and ethinylestradiol [145]. (It is not clear to me whether it was admitted that these tablets also fit the claimed formulation profile, but for the purposes of Fothergill J’s reasoning, we may assume they did.)

Participants were given a large number of the tablets, which were to be self-administered over several months outside of a clinical setting. In all three trials, participants were told what the tablets contained, and knew that the tablets were intended to be used as oral contraceptives. No restriction was imposed on participants regarding the disclosure of information concerning the tablets. The participants did not sign confidentiality agreements. [145-46].

Apotex alleged these trials anticipated the ‘426 patent. Fothergill J held they did not. He pointed out that anticipation requires enabling disclosure, and he held that even if some of the tablets had made their way into the hands of a person skilled in the art, such a person would not have been able to reverse engineer the tablets to discover the particular formulation which constituted the invention without the exercise of inventive ingenuity [154-55]. That finding turned on the facts and the law he applied is not controversial.

More interesting is the “alternative” basis for Fothergill J’s holding that the trial did not anticipate [156]. In Bayer v Apotex 2014 FC 436 a prior NOC case involving the ‘426 patent, the same argument was raised that these same clinical trial were anticipatory. Hughes J held that they were not, on the primary basis that Bayer benefited from an experimental use exception to anticipation. The following key passage from Hughes J's decision was quoted by Fothergill J [159]:

[121] In the present case clinical studies were necessary to prove that the drug was safe and effective and, thereby, gain government approval for sale. Until this had been demonstrated, no commercial sale of the drug could have been made. Bayer took reasonable steps to ensure the confidentiality of the relevant documents and to ensure that unused tablets were returned. The theoretical possibility that some tablets were retained and analyzed is just that, theoretical. This theoretical possibility does not preclude the fact that the studies were experimental, and of necessity, conducted by the provision of tablets to members of the public. Thus these clinical studies are exempted from public use.

As I said in my blog post on Hughes J’s decision, this seemingly establishes a broad experimental use exception to what would otherwise be anticipating disclosure, which applies to any clinical trial, so long as reasonable steps are taken to ensure that the unused tablets are returned. Fothergill J agreed with Hughes J both as to this statement of the law and its application to the facts of this case [156], [159]. Fothergill J also clarified that the fact that these trials had been conducted for the purpose of gaining regulatory approval did not take them outside of the experimental use exception [162].

In my post on Hughes J’s decision, I suggested that his decision was notable because, while there was some case law supporting such a broad exception, it was not well-established. Fothergill J’s holding is therefore significant as reinforcing the law stated by Hughes J.

Blinding Expert Witnesses
Apotex argued that the evidence of its expert witnesses should be preferred to those of Bayer’s witnesses because its experts had been “blinded.” Like Brown J in the recent VIREAD decision, 2016 FC 857 (blogged here), Fothergill J was unimpressed by the arguments in favour of blinding. Fothergill J noted that “[t]he fact that expert witnesses were blinded may be persuasive and helpful in weighing their evidence where credibility concerns arise” [65], but, citing Locke J in Shire 2016 FC 382, [45] (blogged here), he continued to say that “if an expert’s opinion is well supported, then there may be no reason to place less weight on the expert’s evidence merely because he or she was not blinded to certain facts when forming that opinion” [66]. In this case, “I have not found the blinding of expert witnesses to be a significant factor in deciding the legal and factual issues raised by this case” [66]. It is still too early to be sure, but the tide may be turning against “blinding.”

Another Twist on Blinding the Expert

Bristol-Myers Squibb v Teva 2016 FC 580 Mactavish J
            2,250,840 / 2,317,736 / atazanavir / REYATAZ

In a number of recent cases (see here), the parties have tried “blinding” their experts from certain facts in a laudable attempt to reduce the problem of hindsight bias. The Atazanavir decision raised another twist on this practice, which is this subject of today's post. For an overview of the facts, see this post, which also discusses some of the issues related to obviousness; and see this post discussing claim construction.

The point arose in the context of the 840 patent, which claims atazanavir. One of Teva’s experts on obviousness, Dr Romero, was blinded perhaps even more thoroughly than in most previous cases:

[192] Dr. Romero was not told the name of the drug that was at issue in this proceeding, other than the fact that it was a protease inhibitor, nor was she told the names of the parties. She was also asked not to carry out any independent research that might identify the drug in question.

That is, it seems that Teva tried to place Dr Romero in the place of the notional skilled person, trying to solve the problem facing the inventors, without knowledge of their solution. There are a couple of caveats even to this degree of blinding. One is that an expert like Dr Romero cannot forget her own current knowledge, and to the extent that she is familiar with approaches that would not have been common knowledge at the time, she cannot fully avoid the effects of hindsight, even when blinded to the particular facts. Also, as Mactavish J pointed out, “Dr. Romero was provided with a limited selection of the prior art that had been ‘cherry-picked’ by Teva, and her evidence has to be viewed with this in mind” [193]. This point was not merely theoretical; Mactavish J expressed concern that Dr Romero had only been provided with papers dealing with an azapeptide backbone, the class which atazanavir belongs to, and not prior art dealing with other possible backbones [194].

With those caveats, no approach is perfect and this heightened degree of blinding seems to be helpful in avoiding hindsight bias. However, it did not help Teva win its case. The details of Dr Romero's evidence were not spelled out by Mactavish J, but it seems the gist was that there were a finite number of modifications that the POSITA would have made in trying to make a better protease inhibitor [212]. However, Dr Romero proposed some modifications to the backbone which would never have led to atazanavir [195], and

[211] Dr. Romero does not identify which compounds or which substitutions should be made to obtain an improved protease inhibitor in her evidence, or how the POSITA should prioritize them. Importantly, Dr. Romero never states that the POSITA would make the substitutions necessary to get to atazanavir.

In the end, Dr Romero’s evidence may have hurt Teva’s case as much as it helped. The 840 patent survived the obviousness attack, and was ultimately held to be valid.

The fact that blinding the expert did not help Teva in this case helps confirm the value of the practice. If a witness blinded in this manner had arrived directly at the claimed invention, it would seem to be good evidence that the invention was obvious. (Though even this degree of blinding would not be conclusive, in light of the caveats noted above, as well as Locke J’s observation in 2016 FC 382 [46].)

Hearsay is Inadmissible

Pfizer Canada Inc v Teva Canada Ltd 2016 FCA 161 Stratas JA: Ryer, Gleason JJA var’g 2014 FC 248 (here) and subsequent reasons re pre-judgment interest 2014 FC 634 (here) Zinn J
            1,248,540/ 2,199,778 / venlafaxine / EFFEXOR XR / NOC s 8 / Venlafaxine s8 FCA

As discussed in yesterday’s post, which dealt with the burden of proof in establishing causation, the FCA in Venlafaxine s8 held that in order to establish its compensable loss under s 8 of the PM(NOC) Regulations, Teva had to show that it “would and could” have supplied the market for venlafaxine. While Zinn J did not articulate the requirement in quite this way, he nonetheless applied the proper principles of causation in holding that Teva had established the necessary causal link [70]-[73], and in the result he awarded Teva almost $125m as compensation for having wrongly been kept off the market for venlafaxine [2]. However, the FCA held that Zinn J’s holding was vitiated by the fact that he improperly relied on hearsay evidence in coming to this conclusion [75]-[121], and the FCA therefore set aside Zinn J’s judgment and remitted the matter to him for redetermination [174]. At the same time, the FCA also affirmed Zinn J’s holdings with respect to the appropriate start date for the compensable period, on authorized generics in constructing the hypothetical world, and on the start date for assessing pre-judgment interest.

Teva’s position was that if it had received its NOC, its supplier, Alembic would have been able to supply adequate quantities of venlafaxine product at the relevant time [41]. While this was accepted by Zinn J, the only evidence on Alembic’s capacity was provided by Mr. Major, a former executive of Ratiopharm (now Teva) [36]. The difficulty is that almost all of Mr Major’s testimony was hearsay, sometimes double or even triple hearsay. Despite Pfizer’s objections, Zinn J admitted the hearsay evidence, saying the objection went to weight rather than admissibility [121]. The FCA disapproved, noting that

[83] Recently, some rules of evidence have been liberalized, allowing for more flexibility. Seduced by this trend towards flexibility, some judges in various jurisdictions have been tempted to rule all relevant evidence as admissible, subject to their later assessment of weight. But according to our Supreme Court, this is heresy. The trend towards flexibility has not undermined the need for judges to take a rigorous approach to admissibility, separating that analytical step from others, such as determining the weight to be given to evidence.

After reviewing the evidence in question, the FCA remarked that “All of the mischief associated with admitting hearsay evidence is present in this case” [119]. Because Zinn J had admitted evidence that should have been excluded, and that error might have affected the outcome of the case, the FCA set aside the Zinn J’s judgment [121]. I am not sufficiently familiar with evidentiary rulings in the Federal Courts to say whether Zinn J’s decision to admit hearsay evidence was unusual, or whether this FCA’s decision signals a course correction to the FC generally.

On the issue of the start date for the compensable period, Pfizer had argued that the appropriate date was the end of the 45 day waiting period under s 7(1)(d) during which the Minister is precluded from issuing an NOC. The waiting period starts at the time the generic serves an NOA and allows a patentee to seek a prohibition order. In effect, Pfizer argued that in the hypothetical world, it should be assumed that rather than seeking an order of prohibition, Pfizer would have done nothing at all, so that Teva’s NOC would have issued only after the expiry of the waiting period. Zinn J rejected this arugment (see here), and the FCA affirmed for substantially the same reasons, based on the plain meaning of the Regulations as well as the case law [126]-[133].

The FCA also reaffirmed its holding in Apotex Ramipril s. 8 FCA 2014 FCA 68 (see here) that entry of authorized generics should be considered as part of the hypothetical world [134]-[138]

Finally, the FCA also affirmed Zinn J’s holding that pre-judgment interest should be calculated from the date on which the cause of action arises, which is typically the start of the compensable period, and not on the date that the prohibition application is dismissed [145].

Blinding the Expert Witness in the UK

American Science & Engineering Inc v Rapiscan Systems Ltd [2016] EWHC 756 (Pat)

Earlier this month we saw contrasting decisions on the practice of blinding expert witnesses from Zinn J in Allergan v Apotex 2016 FC 344 (blogged here) and Locke J in Shire v Apotex 2016 FC 382 (blogged here). Just days later, the decision of Arnold J in AS&E v Rapiscan addressed the same question. The invention related to an X-ray security scanning system for use at borders. The main question was the obviousness, and both the patentee, AS&E, and the defendant Rapiscan, introduced expert evidence. They both blinded their experts, but in slightly different ways, neither of which was satisfactory according to Arnold J, who made the following general comments on the expert evidence:

109. Each party contends that the other party instructed its expert to ask himself the wrong question. Both sides’ solicitors proceeded in a carefully structured manner by first asking their expert to consider the person skilled in the art and the common general knowledge, then to consider the prior art relied upon by Rapiscan and only then to consider the Patent. The difference between them was that AS&E’s solicitors asked Dr Bjorkholm to consider obvious developments of the prior art before showing him the Patent, whereas Rapiscan’s solicitors only asked Dr Lanza to consider the question of obviousness after they had shown him the Patent.

110. In my view there is force in the criticisms which each side levels at the other’s approach. The approach adopted by AS&E’s solicitors had the advantage that it enabled Dr Bjorkholm to consider obvious developments of the prior art free from knowledge of the Patent; but it meant that he never addressed in his reports the question of whether the differences between Swift and the claimed invention constituted steps which would have been obvious to the person skilled in the art. The mere fact that a step did not occur to Dr Bjorkholm when reviewing the prior art was not sufficient to exclude the possibility that he might agree that it was obvious if asked. Unlike the person skilled in art, real people sometimes miss the obvious.

111. The approach adopted by Rapiscan’s solicitors avoided that difficulty. The problem is that, whereas the correct question is whether, viewed without any knowledge of the claimed invention, the differences constituted steps which would be obvious, Dr Lanza expressed his understanding of the question he had been asked to consider without referring to the need to exclude knowledge of the claimed invention. Moreover, this does not appear to have been an artefact of the drafting of the report. On the contrary, Dr Lanza confirmed in cross-examination that his approach had been to consider obviousness as if the skilled person had been shown the claims and asked if they were obvious. Thus Dr Lanza does not appear to have understood the importance of trying to avoid hindsight.

AS&E’s expert was untainted by hindsight, but for precisely that reason he was unable to focus on “where the shoe pinches.” Rapiscan’s expert could focus on the crucial question, but his evidence was affected by hindsight. Could the problem have been avoided if Rapiscan had emphasized to their expert the importance of trying to avoid hindsight? I don’t think so. As I recall the research on the hindsight bias, being instructed to avoid hindsight does not significantly mitigate the bias.

The problem is inherent in the Windsurfing/ Pozzoli approach to the obviousness, endorsed by the SCC in Sanofi 2008 SCC 61, [67]. As Lewison J noted in Virgin Airways v Premium Aircrafts Interior 2009 EWHC 26 (Pat) at [271]:

Although the structured approach is relatively easy to describe, it can be very difficult to apply. One reason for this is that at the third stage of the structured approach it is necessary to focus on the differences between the prior art and the patent in suit; but at the immediately succeeding fourth stage it is necessary to erase all knowledge of the alleged invention from the mind. That is not an easy task.

“Not easy” is polite; "impossible" would be more accurate.

The FCA also recognized the problem in E Mishan & Sons, Inc v Supertek Canada Inc 2015 FCA 163 (blogged here):

[36] In applying the fourth step of the Sanofi test, in my view, the requirement that this step be completed “without any knowledge of the alleged invention as claimed” does not mean that the differences that were identified in step 3 would be forgotten for step 4. These differences are an essential part of step 4. Without knowing the differences between the relevant prior art and the inventive concept, step 4 could not be completed. The differences are based on the inventive concept of the claims in issue and the relevant prior art and, therefore, are determined based on some knowledge of what is claimed in the patent in issue. Therefore, some knowledge of the alleged invention will be reflected in the differences that are analyzed in applying step 4 of the Sanofi test.

Thus a expert who is blinded as in AS&E’s approach cannot apply the Windsurfing analysis, but an expert who is not so blinded will have their evidence tainted by hindsight.

Pick your poison.

Expert Witness Preferred Because of Blinding

Allergan Inc v Apotex Inc 2016 FC 344 Zinn J
            2,307,632 / gatifloxacin ophthalmic

Yesterday morning I posted on Shire v Apotex 2016 FC 382, in which Locke J gave little weight to the practice of “blinding” the expert witness; then in the afternoon the FC released Allergan v Apotex, in which Zinn J has taken almost the opposite approach to the same issue. Apotex prevailed on the issue of obviousness primarily because Zinn J preferred the evidence of one of Apotex’s witnesses [8], and he preferred the evidence of that witness primarily because she was blinded (though also in part because her expertise was more directly relevant to the issue at hand) (my emphasis):

[12] While I am not convinced that all of these alleged flaws are made out, I am satisfied, for the following reasons, that the evidence of Dr. Sheardown [Apotex’s expert] is to be preferred and given more weight than that of Dr. Fix [Allergan’s expert] and Dr. Myrdal [Apotex’s expert].

[13] As noted by Apotex, Dr. Fix was not blinded; he offered his opinion after having read the 632 Patent and Apotex’s NOA and after having discussed both with Allergan. The Supreme Court of Canada in Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61,[2008] 3 SCR 265 [Plavix SCC] at para 67, directs that an obviousness assessment is to be made “without any knowledge of the alleged invention as claimed.” Relying on this observation, this Court has recognized that evidence from experts who have not seen the patent nor been apprised of the positions of the litigants is to be given greater weight on issues going to obviousness and patent construction than the evidence of an expert with full knowledge of the patent’s disclosure and the positions of the parties: [citations omitted]

[14] Like Dr. Fix, Dr. Myrdal had prior knowledge of the 632 Patent (or the U.S. equivalent) and the positions of the parties. As acknowledged by Apotex, “[Dr. Myrdal] testified in a United States case on the corresponding patent and his evidence … in the present proceeding was consistent with his U.S. evidence.”

[16] Unlike the other experts in pharmaceutical formulation, Dr. Sheardown expressed her opinion on the common general knowledge and the prior art with no knowledge of the patent at issue or the positions of the parties. As such, her responses to the questions asked of her came without any influence, conscious or unconscious. Moreover, of the three, only Dr. Sheardown’s expertise focused on “studying and developing delivery formulations for ophthalmic applications.” Dr. Fix and Dr. Myrdal are expert formulators. However, given that the alleged invention in the claims at issue is specifically directed to an ophthalmic medication in the form of an eye drop, I am of the view that the evidence of the one expert specializing in that area, whose opinion is offered with no possible influence, is to be preferred.

As discussed here, the FCA in Mishan v Supertek 2015 FCA 163 recognized an inherent tension in the SCC’s approach to obviousness. On the one hand, Sanofi [67] says that the differences between the state of the art and the inventive concept must be “[v]iewed without any knowledge of the alleged invention as claimed.” But that is impossible: “The differences are based on the inventive concept of the claims in issue and the relevant prior art and, therefore, are determined based on some knowledge of what is claimed in the patent in issue. Therefore, some knowledge of the alleged invention will be reflected in the differences that are analyzed in applying step 4 of the Sanofi test” [Mishan v Supertek [36]].

So far as I can tell, in this case that tension was resolved by having Dr Sheardown express her opinion “on the common general knowledge and the prior art” [16] without knowledge of the patent or the position of the parties, but she must have then been provided with the patent before opining that “There is no practical difference between the inventive concept of the claims of the 632 Patent and the common general knowledge. Any differences between the inventive concept and the claims of the 632 Patent and what was known to the skilled person as of August 1998 constituted steps that would have been obvious to the skilled person” [34].

There are also two sides to this debate as a matter of policy. While blinding an expert may help avoid hindsight bias, unless the expert is asked to focus on “where the shoe pinches” it might be difficult to elicit relevant evidence. Also, as noted in yesterday’s post, the issue has arisen in the context of claim construction as well as obviousness. Is there a principled difference between the two contexts which would rationalize the divergent case law? In any event, the law on this point continues to develop, but until some consensus is reached it will be difficult to know how to instruct an expert.

Moderation in Blinding Expert Witnesses

Shire Canada Inc v Apotex Inc (NOC) 2016 FC 382 Locke J
            2,348,090 / mixed amphetamine salts (MAS) / ADDERALL XR

In this decision Locke J dismissed Shire’s motion for an order of prohibition in respect of Apotex’s extended release mixed amphetamine salts (MAS) on the basis of non-infringement, without addressing the other grounds raised. The decision turned on claim construction, and while Locke J considered a variety of technical arguments, in the end his construction and the consequent conclusion of non-infringement was quite straightforward. The most interesting aspects of the decision are Locke J's comments on “blinding” of expert witnesses, and his analysis of the inconsistency in the SCC’s Free World Trust decision on claim construction.

The ‘090 patent is entitled “Oral Pulsed Dose Drug Delivery System.” It claims an extended release formulation of mixed amphetamine salts which mimics a twice-daily dosage by means of “an immediate release dosage form containing a first dosage amount . . . and a second dosage form containing a second dosage amount . . .which has a release onset lag time,” with a correspondingly pulsed release profile [80]. Examples in the patent describe a capsule containing one dose in an immediate release form combined with a second dose in an enteric coating. Apotex’s product, in contrast, is a uniform tablet consisting of a uniform matrix in which MAS and excipients are dispersed in an enteric polymer [23]. It achieves its extended-release characteristics by virtue of the changing release mechanism from diffusion to a combination of diffusion and erosion as the tablet passes from the stomach into the intestine [24]. The technical claim construction exercise confirmed that this took Apotex’s product outside the claims of the ‘090 patent [157]. Locke J’s claim construction analysis strikes me as entirely compelling.

Of more general interest are Locke J's comments on “blinding” the expert witness, a practice which has been raised in a couple of recent cases. To recap, in Esomeprazole 2014 FC 638 Rennie J made the following remarks, in the context of obviousness (my emphasis):

[321] First, Apotex’s experts’ disbelief in a fear of racemisation facing the skilled chemist is more credible because its experts more closely emulated the perspective of the skilled person. Drs. Jacobsen and Danheiser (for Apotex) had mandates that allowed them to opine on the state of the art, in the words of the Supreme Court of Canada, “viewed without any knowledge of the alleged invention as claimed” (Sanofi-Synthelabo Plavix, at para 67), while both Drs. Davies and Armstrong (for AstraZeneca) did not. More specifically, the Apotex experts were “blinded” from the 653 for their initial reports addressing whether and how the enantiomers of omeprazole could be obtained. By contrast, Dr. Davies has given extensive evidence in prior esomeprazole litigation, while Dr. Armstrong, to a lesser extent, has also addressed the ‘653 patent in a prior case

Then, in her Rasagiline 2014 FC 1070 decision, (blogged here, and see also here) Gleason J, citing Rennie J’s Esomeprazole 2014 FC 638 decision, made this statement in the context of claim construction (my emphasis):

[94] Secondly, I agree that the manner in which the experts were retained and instructed in this case provides a reason to prefer the evidence of the Apotex experts over that of the Teva experts. Because they did not know what alcohol Apotex had used in its Products when they conducted their construction exercise, their interpretation was undertaken in accordance with the direction from the Supreme Court of Canada, requiring that the construction exercise be uninfluenced by concerns over infringement or invalidity. The Teva experts, on the other hand, conducted their construction of the terms with a view to the potentially infringing substance. This is evident from the terms of their affidavits, which indicate that the molecular structure of [. . .] was factored into the construction exercise.

These cases indicated a nascent trend in favour of “blinding” experts. But then in Apotex / Tadalafil 2015 FC 875, Gleason J resiled somewhat from this suggestion (my emphasis):

[166] Insofar as concerns the allegation regarding lack of “blinding”, Apotex has tried to apply the decisions in Teva [Rasagiline] and AstraZeneca [Esomeprazole] out of context. There, the experts whose credibility was found to be wanting based their construction of the patents in suit with a view to infringement and were able to come to their opinions based on the information in the generic company’s NOA. In Teva, this led to an especially tortured construction. In Teva and AstraZeneca, the approach taken was found to undercut the experts’ credibility as it led to an improper results-oriented opinion. Neither case can be read for the position that Apotex sought to advance here, namely, that in any case where one party blinds its experts but the other does not, the former’s evidence is to be preferred. Rather, these two decisions must be limited to the facts that arose in these cases.

In the case at hand Apotex’s experts never saw the NOA and were never told Apotex’s legal position, while Shire’s experts were not similarly blinded [42]. Apotex argued that the evidence of its experts should be preferred for that reason [43]. Locke J rejected this suggestion, at least insofar as it would represent a general rule (citations omitted):

[45] I agree to some extent with both parties. In some situations, the fact that an expert witness was unaware of the features of an allegedly-infringing product when they formed their opinion on claim construction may be helpful in deciding the weight to be placed on that expert’s opinion. However, I agree with Shire that favouring the evidence of experts who have been blinded has not been raised to the level of a legal principle that must be applied in all cases, and is merely persuasive. I am mainly interested in the substance of an expert’s opinion and the reasoning that led to that opinion. If it is well-reasoned, there may be no reason for concern about whether the witness was blinded to certain facts when giving the opinion. A concern may arise where the expert’s opinion seems tortured or less well-reasoned.

The reference to “tortured” evidence echos Gleason J’s statement in Tadalafil. This suggests that blinding an expert will only be helpful if the expert's evidence seems tortured. While that would normally be a reason for discounting the evidence, if the tortured evidence was obtained from an expert who had been blinded, it might nonetheless retain some credibility.

Locke J also made a very interesting critique of the premise of the argument in favour of blinding:

[46] I am also conscious that the blinding of witnesses is no guarantee that the expert evidence before the Court is reliable. It would not be difficult (though it would be expensive) for an unscrupulous party to seek opinions from a number of experts, keeping them all blind to unnecessary information. If one of those many experts provided the opinion that the party sought and all of the others concluded otherwise, the party would be able to retain the outlier and present him or her as a blinded (and therefore reliable) witness.

Finally, on a different topic entirely, Locke J also had an interesting “Aside on claim construction principles” [134]–[144], in which he discussed the evident inconsistency between the SCC’s Free World Trust 2000 SCC 66 claim construction principles and its treatment of the so-called Improver questions (originally formulated by Lord Hoffmann when he was sitting in Chancery). After reviewing a number of cases and commentators discussing the problem, Locke J concluded (original emphasis) that:

[137] In my view, the SCC likely intended that, in order for a patentee to establish that a claim element is non-essential, it must show both (i) that on a purposive construction of the words of the claim it was clearly not intended to be essential, and (ii) that at the date of publication of the patent, the skilled addressees would have appreciated that a particular element could be substituted without affecting the working of the invention.

I won’t go into the details, as the discussion is arcane, even by patent law standards. Lord Hoffmann himself has called the Improver questions a mangle (Kirin-Amgen [2004] UKHL 46, [52]), and it is fair to say that the SCC’s gloss did not clarify them. Moreover, the Improver questions are rarely used, and nothing in Locke J’s interpretation of Free World impacted his decision – as he said, it was an aside. But if the question does arise again, Locke J’s analysis will have to be taken into account.

Latitude in Admitting Hearsay Evidence Contained Within Facially Reliable Scientific References

Takeda Canada Inc v Mylan Pharmaceuticals ULC / pantoprazole (NOC) 2015 FC 751 Barnes J
             2,341,031 / pantoprazole magnesium dihydrate / TECTA

In this NOC proceeding Takeda’s 031 patent claiming pantoprazole magnesium dihydrate was found to be not infringed and invalid for anticipation. Both aspects of the decision turned entirely on the facts. The most interesting aspect of the decision is Barnes J’s discussion of hearsay evidence in NOC proceedings, and in particular his statement that “some latitude should be extended to the reliance by expert witnesses upon hearsay contained within authenticated and facially reliable scientific references” [92].

Pantoprazole magnesium is a known gastric acid inhibitor, and the dihydrate form was the inventive concept of the 031 patent [3]. The relevant prior art was Example 10 of an international patent application [27]. As Barnes J noted, the test for anticipation is strict and requires that following the directions in Example 10 would “inevitably or necessarily” produce pantoprazole magnesium dihydrate. “If the evidence discloses on a balance of probabilities only that a dihydrate will sometimes be the result,” the attack based on anticipation will fail [39]. The only direct evidence was provided by Mylan’s expert, who testified that by following the directions in Example 10 he had produced pantoprazole magnesium dihydrate [40]. Takeda’s expert suggested that different choices might have produced a different result, but those concerns were all “theoretical” and Barnes J was not persuaded [48]. The fact that Takeda did not conduct any tests to determine whether Example 10 would produce the dihydrate form substantially undermined its case [49] (though of course, if Takeda had carried out such tests and they had all produced the dihydrate form, that would not have helped either).

Mylan argued its pantoprazole magnesium product did not infringe because it was the hemipentahydrate, not the dihydrate. The issue turned entirely on whether Mylan’s product was indeed the hemipentahydrate. Barnes J took into account the fact that Mylan’s ANDS submitted to the Minister of Health reports that its product was characterized by various testing methods and found to be a hemipentahydrate [15]. He held that the fact that the Mylan’s product specification allowed for a range of water content that encompassed both the dihydrate and hemipentahydrate, “says very little about what is actually produced” [60], and “it would take far stronger evidence than this to support an inference that Mylan’s disclosure about its product to the Minister was deceitful” [62]. Barnes J also considered evidence related to various tests used to characterize Mylan’s product, and he concluded that Takeda had not carried its burden of showing that Mylan’s product was the dihydrate, particularly in light of the imprecision of many of the tests [79]. [104]. Again, Takeda’s failure to carry out its own characterization tests weighed against it [103].

A significant piece of evidence relied upon by Mylan to characterize its product as a hemipentahydrate was the fact that the XRPD pattern obtained by Mylan for its product matches the XRPD pattern reported in US patent application 623 for a product characterized by the US 623 inventors as pantoprazole magnesium hemipentahydrate [88]. Takeda attempted to block the introduction of this evidence as hearsay [90]. Barnes J held it was indeed hearsay [90] and it did not fall clearly into one of the previously recognized exceptions to the hearsay rule [91]. Nonetheless, he considered it:

[91] In particular, there is no evidence before me to show that the admission of this evidence was justified on the basis of its necessity. That said, the opinions expressed by expert witnesses in patent litigation frequently rest on their acceptance of the accuracy of hearsay references concerning scientific issues or for the interpretation of prior art. In some cases, this is justified on the ground that experts in a particular field are permitted to rely on the accuracy of widely accepted and publicly reported data.

[92] Given the summary nature of NOC proceedings, I am of the view that some latitude should be extended to the reliance by expert witnesses upon hearsay contained within authenticated and facially reliable scientific references. The contents of US 623 were disclosed in Mylan’s NOA and its expert witnesses relied on the reported findings in support of their own analysis. Where such a reference contains sufficient information to allow the opposite party to replicate the work and assess the accuracy of the reported data, that party suffers no material prejudice by the admission of hearsay in support of an expert’s opinion. It was open to Takeda to run the same tests reported in US 623 and to fully characterize the resulting compounds. Despite the significance of this evidence, Takeda chose not to make that effort.

Obviousness and “Blinding” an Expert

E Mishan & Sons, Inc v Supertek Canada Inc 2015 FCA 163 Webb JA: Ryer, Near JJA aff’g 2014 FC 326 Hughes J
            2,779,882 here

In Mishan v Supertek the FCA has affirmed Hughes J’s finding that the 882 patent is invalid for obviousness. As discussed here, the trial decision largely turned on the the factual issue of whether a particular piece of prior art would have been found in a reasonably diligent search and it is not surprising that the FCA affirmed, using a deferential standard of review [25]. The case does raise an interesting legal point regarding the role of hindsight in the obviousness analysis.

The invention at issue is a lightweight expandable and contractible garden hose, comprising an elastic inner tube and an inelastic outer sleeve. When the hose is empty, the elasticity of the inner tube causes it to contract. When it fills with water, the inner tube expands; since the diameter is constrained by the outer sleeve, it elongates [3]. The key prior art was the McDonald patent, which disclosed a very similar hose, albeit one that was intended as an oxygen hose for an aviation crew oxygen mask. Hughes J found that the 882 invention was obvious over the McDonald patent.

On appeal, Mishan argued [35] that Hughes J had erred by using his knowledge of the 882 Patent to identify the differences between what is claimed in the 882 patent and the McDonald patent and to determine that the differences were obvious, on the basis that this is contrary to the fourth step of the Windsurfing / Pozzoli  test, adopted in Sanofi 2008 SCC 61 [67], which asks whether the invention would have been obvious in light of the state of art “viewed without any knowledge of the alleged invention as claimed.” There is considerable force to Mishan’s argument. As Lewison J explained in Virgin Atlantic 2009 EWHC 26 (Pat) [271-72]:

at the third stage of the structured approach it is necessary to focus on the differences between the prior art and the patent in suit; but at the immediately succeeding fourth stage it is necessary to erase all knowledge of the alleged invention from the mind. That is not an easy task. . . . If an expert approaches his own task in the manner set out in Pozzoli, he will almost inevitably expose himself to a charge of having approached the final question with the aid of hindsight.

The FCA nonetheless rejected Mishan’s submission, pointing out that the difficulty is inherent in the Windsurfing / Pozzoli framework:

[36] In applying the fourth step of the Sanofi test, in my view, the requirement that this step be completed “without any knowledge of the alleged invention as claimed” does not mean that the differences that were identified in step 3 would be forgotten for step 4. These differences are an essential part of step 4. Without knowing the differences between the relevant prior art and the inventive concept, step 4 could not be completed. The differences are based on the inventive concept of the claims in issue and the relevant prior art and, therefore, are determined based on some knowledge of what is claimed in the patent in issue. Therefore, some knowledge of the alleged invention will be reflected in the differences that are analyzed in applying step 4 of the Sanofi test.

Thus the statement that the fourth step of the test must be undertaken “without any knowledge of the invention as claimed” cannot be understood literally. It is really just an awkward way of repeating the standard warning against being influenced by hindsight: see eg Wandscheer [1948] SCR 1 at 12.

Though the FCA was bound to reject this objection as a matter of law, what about as a matter of policy? Is there any alternative? Lewison J said in order to avoid the problem of hindsight bias, “[t]he structured Pozzoli approach is a series of steps directed to the court; not to experts” [272]. But this does not solve the hindsight bias, as it is empirically well-established that judges are also subject to the hindsight bias – if anything, to a greater extent than experts in the art.

One alternative approach would be to “blind” the expert to the invention, by asking them to answer the problem addressed by the inventor without knowing the inventor’s solution. In this case, we would simply ask the experts – or rather a skilled person – to design a lightweight expandable and contractible garden hose, and see if they come up with the invention. This would avoid hindsight by asking each expert to fully replicate the inventive process faced by the inventor. But if done faithfully, this would often be unworkable, as the cost of litigation could exceed the cost of invention. With that said, “blinding” the expert to the solution might be workable in some cases, such as where the question is whether the invention is obvious to try; if the expert is blinded and yet readily suggests a route that in fact worked without difficulty, this would be good evidence that the proposed route was indeed obvious to try: see eg Esomeprazole 2014 FC 638 [321].

This relates to the question of whether experts should be blinded in claim construction. As discussed here, in her Rasagiline 2014 FC 1070 decision, Gleason J indicated at [94]-[97] that the blinding of the Apotex experts in that case was reason to prefer their evidence over that of Teva’s experts. But more recently, in Apotex / Tadalafil 2015 FC 875 [166], she explained in effect that both her Rasagiline decision and Rennie J’s Esomeprazole decision turned on the facts. That is, blinding is not always preferred, though in some circumstances it might be preferred. This seems right to me. There is a tradeoff between avoiding the hindsight problem and keeping costs of litigation manageable by focusing on “where the shoe pinches,” and how that balance is best achieved will depend on the facts. Unfortunately, that means there is no easy way to for a litigant to decide whether to blind its experts in a particular case.(Note that Rasagiline concerned claim construction while Esomeprazole and Tadalafil concerned obviousness.)

Should Experts Be “Blinded” as to the Infringing Device When Construing the Claim?

Teva Canada Innovation and Teva Pharmaceutical Industries Ltd v Apotex Inc (NOC) 2014 FC 1070 Gleason J
            2,232,310 / rasagiline / AZILECT

In this NOC decision, which turned entirely on claim construction, Apotex’ Apo-rasagiline product was found not to infringe Teva’s ‘310 patent. The main point of legal interest is Gleason J’s holding that if an expert is “blinded” as to the nature of the putatively infringing product when carrying out their claim construction, this is a reason to prefer that evidence over the evidence of an expert who is not so blinded.

The ‘310 claims a pharmaceutical composition comprising rasagiline and at least one alcohol selected from the group consisting of “pentahydric and hexahydric alcohols” [7]. It was undisputed that the term “pentahydric” refers to five hydroxyl, or “-OH” groups, and that the term “hexahydric” refers to six hydroxyl groups [20]. So, for example, mannitol is pentahydric:

Apotex’s product comprised rasagiline and an alcohol, and the sole question was whether that alcohol was pentahydric or hexahydric. While the exact alcohol used by Apotex was redacted (with the redaction to be removed once Apotex’ NOC is issued) [5], the problem can be understood if we suppose Apotex’ product contained maltitol:

Apotex’ experts opined that in naming an alcohol, all the -OH groups in the molecule should be counted, while Teva’s experts were of the view that only the groups on the alcohol moiety should be counted. So, on the former view maltitol would be a nonahydric alcohol, and on the latter view it would be pentahydric.

Gleason J accepted the view of Apotex’ experts, primarily - or at least "firstly" - as a matter of textual construction of the specification. In particular, the specification uses the term “alcohol” to refer to the entire molecule to be used in the composition, not just the alcohol moiety, and it uses the term “pentahydric or hexahydric” to modify the term “alcohol,” thus implying that all the -OH groups in the molecule must be counted, not just those on the alcohol moiety [89]-[93].

A second reason that Gleason J preferred the evidence of Apotex’ experts is of more general interest. Apotex’ experts had been provided with the ‘310 patent and asked to construe it, and only subsequently were they provided with Apotex’ ANDS and asked to opine as to whether Apo-rasagiline fell within the claims [43]-[46]. Teva’s experts, on the other hand, construed the ‘310 patent with the allegedly infringing substance in mind [34]-[42]. Gleason J held that the way in which they had been instructed was a reason to prefer the evidence of Apotex’ experts [94]. (Though she did not suggest it was a determinative reason.)

As Gleason J acknowledged [96], this raises the tension between the principle that “the construction exercise [should] be uninfluenced by concerns over infringement or invalidity,” and the competing principle that in construing claims "it is essential to see where the shoe pinches” Nokia v Interdigital [2007] EWHC 3077 (Pat) [25], quoted with approval in Qualcomm v Nokia [2008] EWHC 329 (Pat) [7], quoted with approval by Hughes J in Shire Biochem 2008 FC 538, [22] (and see 2009 FC 991 [88]; 2009 FC 676 [82]). Gleason J said that

However, the decision in Shire Biochem does not stand as authority for the proposition that it is proper to construe a patent with the infringing substance in mind, but, rather, only for the common sense notion that to be useful evidence and arguments in a case must be directed toward the issues that arise.

This is not quite right. What Floyd J said in Qualcomm, quoted with approval by Hughes J in Shire Biochem, is that

It is often said that a patent specification should be construed without reference to the infringement. Yet one cannot sensibly identify the point of construction without understanding what it is about the alleged infringement which is said to take it outside the claims.

So, when the claim calls for A, and the allegedly infringing device requires B, “the right question is . . . whether in its context in the specification the skilled man would appreciate that A in the claim encompassed B” (Qualcomm [25]). This necessarily requires focusing on the allegedly infringing device. Similarly, in Technip France SA's Patent (2004) RPC 46, quoted in Shire Biochem, Jacob LJ remarked that “in most sensible discussions of the meaning of language run on the general lines `does it mean this, or that, or the other?' rather than the open-ended `what does it mean'?” In Nokia, Pumfrey J prefaced the quoted remark with the statement that “it seems sensible to turn to the [allegedly infringing product] to identify the points of construction that arise” [25]. He specifically directed the parties to serve statements of the case identifying the relevant aspects of the allegedly infringing product for the experts to focus on in construing the claims, and he indicated that such statements are “essential” [26], at least in a complex case.

Two SCC decisions cited for the proposition that claim construction is independent of validity and infringement are Whirlpool 2000 SCC 67 and Sanofi 2008 SCC 61. In Whirlpool the Court said that “Claims construction is antecedent to consideration of both validity and infringement issues” [43]. This may be taken to say that construction should not be influenced by concerns over infringement or invalidity, but it does not say that claim construction should be undertaken without reference to the infringing product. In holding that the report of the experts who had been “blinded” should be preferred, Gleanson J cited Rennie J’s holding to the same effect in Omeprazole 3 2014 FC 638, [321]. Rennie J held that the “blinded” experts “had mandates that allowed them to opine on the state of the art, in the words of the Supreme Court of Canada, ‘viewed without any knowledge of the alleged invention as claimed’ (Sanofi-Synthelabo Plavix, at para 67).” But that statement in Sanofi was made in the fourth step of the Windsurfing / Pozzoli test for obviousness

(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?

What this is saying is that the obviousness inquiry must be undertaken without the benefit of hindsight. Claim construction is step (2) of the test, and Sanofi does not say that claim construction should be undertaken without reference to the infringing product.

Apart from these authorities, I see a danger in ignoring the infringing device. Suppose that almost all alcohols were simple linear chain molecules, so that there is normally no difference between counting -OH groups in the alcohol moiety and counting them in the molecule as a whole. If asked the general question of how to define a pentahydric alcohol, a skilled person might say “count the -OH groups in the molecule.” But if then presented with an unusual alcohol with two distinct parts, the skilled person might well say “Well, I never thought of that – of course I meant that when there are two parts to the molecule, you should count the -OH groups on the alcohol moiety.” Imagine trying to give legal advice to a client who insisted on asking “what are the requirements for a valid patent,” while refusing to disclose her invention, and who then insisted on holding you to your original definition after revealing the peculiarities of her own invention.

I take the point that claim construction should not be tendentious. But it seems to me that ignoring the infringing device in claim construction can also be misleading. Either course has its risks. Rather than preferring the evidence of experts who have been blinded, perhaps it would be better to recognize the problem of tendentious testimony on the one hand, and misdirected evidence on the other.

Finally, Gleason J remarked that

[96] Teva could easily have directed its experts’ attention to these issues by posing the question whether the terms “pentahydric or hexahydric alcohols” as used in the 310 Patent would connote a molecule or a moiety to the skilled person, without alerting the experts to the fact that the potentially infringing substance was [redacted].

I don’t find this persuasive. I agree that this would have properly directed the experts’ witness to where the shoe pinches, but I’m not sure this type of instruction is any better than revealing the allegedly infringing molecule itself. The experts knew that all the alcohols specifically mentioned in the specification were linear chain alcohols (mannitol, sorbitol and xylitol), and an expert instructed to consider whether the term connoted a molecule or a moiety could readily have inferred that the infringing substance had two distinct moieties, which would defeat the purpose of the blinding. More importantly, this approach demands an excessive degree of foresight from counsel; how can counsel, who are not normally themselves persons skilled in the art, know in advance which aspects of the allegedly infringing product are relevant to the claim construction? How would they known to present the molecule / moiety distinction before having an opinion from an expert that it was relevant? Perhaps in this case the particular point might have been obvious to a pharmaceutical litigators of ordinary skill, but as a general matter we cannot presume that litigators will know “where the shoe pinches” before they are told by experts.

Allegation of Non-infringement Need Not Be Put “In Play”

Bristol-Myers Squibb & Gilead Sciences v Teva / efavirenz (NOC) 2015 FCA 3 Near JA: Dawson, Stratas JJA aff’g 2014 FC 30 Barnes J
             2,279,198 / efavirenz / ATRIPLA

In this NOC proceeding, the FCA has affirmed Barnes J’s decision that the patentee failed to established that Teva’s product would infringe the ‘198 patent for a particular crystalline form of efavirenz. The decision at first instance (blogged here) turned entirely on the facts, and the FCA affirmed on the basis that the appellant patentee had not established and palpable and overriding error.

The only point of general legal interest is that the FCA held that when non-infringement is alleged in an NOC proceeding, there is no evidentiary burden on a generic to adduce evidence in order to put that allegation “in play.” It is enough to make the allegation in the NOA, and the burden is then on the patentee to prove infringement on the balance of probabilities [11], [8]. This is in contrast to an allegation of invalidity, in which the generic must adduce some evidence to put the allegation of invalidity into play before the burden shifts to the patentee to disprove invalidity. The reason for the difference is the presumption of validity under s 43(2) of the Act [10].