Monday, June 12, 2023

Stay Pending Re-Examination Denied

Pfizer Canada ULC and Pfizer inc v uniQure BioPharma BV 2023 FC 629 Furlanetto J

2,737,094 / Modified Factor IX Polypeptide / HEMGENIX

Pfizer has a product that has undergone a Phase 3 clinical trial that would arguably infringe uniQure’s 094 patent. Pfizer therefore brought an action last fall challenging the validity of several key claims [5]. Shortly thereafter, uniQure filed a request for re-examination pursuant to s 48.1, allegedly in response to new prior art that was brought to uniQure’s attention during foreign proceedings involving Pfizer [10].

In this motion, uniQure sought a stay of Pfizer's impeachment action pending the outcome of the re-examination. There is no statutory bar to impeaching a patent that is under re-examination [42], so the decision to stay is discretionary, guided by the aim of “securing the just, most expeditious, and least expensive determination of the proceeding on its merits,” without unfairly prejudicing one of the parties [19]. In the result, Furlanetto J refused to stay the impeachment action, essentially because the outcome of the re-examination would not sufficiently simplify the impeachment proceeding to warrant a lengthy stay of up to a year.

The crux of uniQure’s argument was that the claims would likely change as a result of re-examination and it would be pointless to litigate claims that would no longer be in effect [21]. The Re-examination Board might cancel the existing claims or it might accept some or all of the amended claims proposed by uniQure. Moreover, uniQure undertook to not to defend the existing claims if the Board accepted any of its proposed claims [14].

However, uniQure acknowledged that the crux of the invention remained the same under the proposed claims [25]. Consequently, the attacks based on anticipation, obviousness and misrepresentation under section 53 would remain largely unaffected [25], [40]. The amendments certainly would not dispose of the litigation [25].

The arguments based on utility / overbreadth and patentable subject-matter might or might not be affected, depending on whether the Board accepted uniQure’s proposed claims and if so, which ones [25]–[27]. While uniQure argued that documentary discovery would be narrowed without the issues of utility and claim breadth [28], Furlanetto J found that discovery would not be significantly narrowed because the documents are issue were probably relevant to other issues put in play by the pleadings [29]-[32]. (This is aside from the question of whether the Board would adopt the proposed claims.)

Further, Furlanetto J pointed out that

[38] uniQure was and has always been free to choose its own litigation strategy. It was uniQure’s choice to wait to seek re-examination in Canada despite narrowing its claims elsewhere well in advance of the initiation of the Action. It cannot now claim prejudice from circumstances created in part by its own doing. There is also nothing preventing uniQure from making formal admissions in the Action to limit what it perceives as unnecessary areas of inquiry for discovery in view of positions it has taken in the re-examination.

Furlanetto J also found that uniQure would not be unfairly prejudiced if the action went ahead [25]–[37]. The wait for re-examination could be up to a year, and re-examination would have to have an impact that was “not. . . tenuous” to justify a stay of such length [41]. Consequently, Furlanetto J dismissed uniQure’s motion for a stay.

Thursday, June 8, 2023

Routine Correction of Inventorship re Patent which is the Subject of Litigation

Regeneron Pharmaceuticals, Inc v Canada (Attorney General) 2023 FC 768 Grammond J


This was a routine correction of inventorship pursuant to s 52, to add an inventor who had been inadvertently omitted. Two points of note: Regeneron did not provide affidavits from the other inventors, but Grammond J noted that this is not a bar to such an application, citing CAE Inc 2021 FC 307 [22]. Second, the main consideration on a change of inventorship is whether third party rights might be affected. Consequently, “[a]n application pursuant to section 52 should include a statement that the patent at issue is not the subject of pending litigation or evidence allowing the Court to find that granting the application would not affect the rights of third parties” [4]. In this case, the 276 patent is currently the subject of litigation. Counsel for Regeneron gave notice of the application to counsel for the other parties in these other proceedings, and as no one has sought to intervene in this application, Grammond J was satisfied that third party rights were not affected [4].

Wednesday, June 7, 2023

The Role of the Inventive Concept in an Obvious to Try Analysis

Eli Lilly Canada Inc v Apotex Inc 2023 FCA 125 Rivoalen JA: de Montigny, Gleason JJA affg 2020 FC 816 St-Louis J

2,371,684 / tadalafil / CIALIS ADCIRCA / FC Selection / FC Anticipation

This case is ultimately a straightforward example of the asserted claims being invalid on an obvious-to-try analysis, but because of the way it was argued it also sheds some light on the role of the inventive concept in the obviousness analysis.

The asserted claims of the 684 patent are to dosage forms of tadalafil for treating ED, namely doses from 1 to about 20 mg, as well as specific doses within that range, including 2.5, 5, 10 and 20 mg doses [FC 197-213]. The question in this case was whether the 684 patent is valid over the prior art 2,226,784 patent, which claims tadalafil for the treatment of ED, and disclosed a dose range from 0.2 to 400 mg [12]. At trial, St-Louis J held on the facts that starting from the knowledge that doses from .02 to 400 mg were useful, it would be routine for the skilled team to carry out the trials necessary to narrow that down to the range providing the best balance between efficacy, and safety and tolerability, and they would be motivated to do so [FC 325–28]. The claimed invention was therefore obvious to try [FC 323, 330]. The FCA has now affirmed on that basis [65]–[80].

Lilly’s challenge on appeal was to find a question of law to attack in St-Louis J’s essentially factual finding. Lilly argued that St-Louis J had erred in her construction of the inventive concept, a question of law [48] arising at step 3 of the Windsurfing test for obviousness, which was adopted in Sanofi 2008 SCC 61 [67]. Lilly waffled in its argument as to what constituted the specific inventive concept, before settling on the position that the inventive concept is that the claimed dose remains effective in treating ED, with a reduced flushing side-effect as compared to larger doses of tadalafil [20]–[27], [61]. (As an aside, getting an extra four years of exclusivity on a popular drug on the basis of reduced flushing would be grist for the mill for critics of evergreening practices. From a PR perspective, it is probably a good thing for Lilly that this patent was invalidated.)

There has been a debate as to the role of inventive concept in assessing obviousness, which came to the fore in Shire 2021 FCA 52. One central issue is whether the inventive concept is the “end point” of the obviousness inquiry (Shire [65]), or is rather a “distraction” that can be avoided if it is unhelpful Ciba 2017 FCA 225 [76]–[77]: see here. Rivoalen JA held that in this case, it did not matter whether Lilly was right as to the nature of the inventive concept; the claims were invalid for obviousness in any event [49].

As noted, St-Louis J used an obvious-to-try analysis, which was endorsed by Rivoalen JA [65]. (So far as I can tell, Lilly did not dispute that the obvious-to-try test was appropriate.) St-Louis J found that carrying out a drug dosing study is typically done in Phase II clinical trials, and it is normally routine work [FC 325]. Such studies aim to identify the dosage that provides the best balance of efficacy, safety and tolerability [69]. In reviewing the factors relevant to an obvious-to-try analysis, Rivoalen JA pointed out that the reduced flushing that was eventually identified as an advantage of the optimal dose does not change the aim of identifying the dose range that offers the best balance [72]. Further, on the facts that the dosing study in this case was routine; again, this conclusion is not affected by the fact that reduced flushing turned out to be one of the advantages of the optimal dose [73]–[77]. After carrying out this routine dosing study, the skilled person would be motivated to identify and commercialize the optimal dose [79]. Consequently, the claimed dosage range was obvious [80].

To summarize, there was nothing inventive about carrying out the dosing study and identifying the optimal dose—and that conclusion does not depend on the precise properties of the final dose. While minimizing the flushing side effect was one goal of the dosing study, it is possible that the optimal dose would not have reduced flushing significantly; while flushing was a side effect of interest, it is a relatively minor side-effect, certainly compared to other side-effects such as passing out from low blood pressure. So, before carrying out the trials, the skilled person might not have predicted that the optimal dose would have reduced flushing. Nonetheless, there was nothing inventive about the dosing studies, even though not all the specific properties of the optimal dose could not have been predicted ex ante. This is really the whole point of the obvious-to-try analysis: when something is obvious to try (finding the optimal dose) and the trials themselves are routine, the resulting product is obvious, even if not all of its properties could have been predicted in advance.

In other words, apart from the distraction of the inventive concept debate, this was a perfectly ordinary application of the obvious-to-try test, and the patent was invalidated on that basis both at trial and on appeal.

What does this tell us about the role of the inventive concept? Rivoalen JA was very explicit that she was accepting Lilly’s construction of the inventive concept only for the sake of argument, and her conclusion did not turn on whether that was the true inventive concept [49], [61]. On its face, this implies that it is not always necessary to identify the inventive concept in order to assess obviousness.

But there is also a debate as to how to define the inventive concept. In this case, Lilly seemed to be using it to mean new information that was disclosed in the patent and embodied in the claimed subject-matter. But the inventive concept has also been equated to “the solution taught by the patent” (Bristol-Myers 2017 FCA 76 [65]). In a previous post, I argued that the focus on the obviousness inquiry should be on whether the subject-matter defined by the claim is the solution to the objective problem that would have faced the skilled person. This is consistent with Rivoalen JA’s analysis in this case. In a dosage study, the problem is to find the dose that best balances efficacy against side-effects. In this case, the solution to that problem was a dose from 1 to about 20 mg. On the facts, that solution was obvious on an obvious-to-try analysis.

So perhaps the underlying issue is how to define the inventive concept. If we define it as the solution to the objective problem, then perhaps it is the proper focus of the obviousness inquiry; that view is at least consistent with the result and analysis in this case. On that view, the real lesson of this case is that if we are going to use the inventive concept as part of the obviousness analysis, we cannot allow the patentee free rein in defining it.

Finally, St-Louis J had also held that that the 684 patent was anticipated by the prior art 784, and she had an extended discussion of whether the 684 patent was a selection patent, evidently on the view that this had important consequences for validity. I had criticized her analysis of both these points: see here and here. In light of her holding that the patent was invalid for obviousness, Rivoalen JA found it unnecessary to address these issues; she added that “[t]hese reasons, however, should not be viewed as endorsing the Judge’s findings or reasons in respect of these issues” [82].

Tuesday, June 6, 2023

Summary Judgment Denied

Meridian Manufacturing Inc v Concept Industries Ltd 2023 FC 20 Zinn J

3,036,430 / Hopper Bottom for Storage Bin

In this brief decision Zinn J dismissed a motion for summary judgment, essentially on the basis that there were disputed factual issues related to both infringement and validity which would likely turn on the credibility of various witnesses [49], [54].

We have seen something of a resurgence in the use of summary disposition in patent cases, starting with Manson J’s decision in Canmar 2019 FC 1233 (here) affd 2021 FCA 7 (here), but we have also seen some pushback, notably in Gemak 2022 FCA 141 (see here): [122]–[124]. The trial judge has quite a lot of de facto discretion in deciding whether to grant summary disposition, and of course, even in a more favourable regime some summary disposition motions will be denied, and vice versa. So each case is an exercise in reading the tea leaves to try and tell whether it signals a trend.

It’s hard to get a read on those tea leaves in this case. Zinn J pointed to specific defects in the evidence, eg it was not clear whether a device that was allegedly anticipatory was part of the prior art [54]. That’s a good reason to deny summary disposition even with a more permissive regime, but on the other hand, if he had been so inclined, he might have proceeded nonetheless, relying on the principle that the parties must put their best foot forward.

Also, I must say I found some aspects of the decision a bit hard to understand. One of the issues where Zinn J found a fundamental disagreement was regarding the essential elements of the claims: “Specifically, [the parties] disagree on whether claims 3 and 7 are essential” [46]. What’s strange here is that essentiality has to be decided on a claim by claim basis, and it is claim elements that are essential or otherwise, not the claim itself: Shire 2021 FCA 52 [55]. Further, there was a dispute as to “[w]hether the ‘solid inner wall’ is an essential component,” and this was crucial to the infringement issue [47]. But so far as I can tell, the term “solid inner wall”—which Zinn J placed in quotes—does not appear in the claims, or anywhere at all in the patent. Presumably the phrase was being used as a shorthand for a claim element and the parties would know which element was at issue. But it does make the decision hard to interpret.

So, at the end of the day, we have another decision refusing to grant summary judgment, and I’m not sure how much more we can extract from those tea leaves.

Thursday, June 1, 2023

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.