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.

What Does “Or” Mean?

Eli Lilly Canada Inc v Teva Canada Limited 2022 FC 1398 St-Louis J

2,226,784 / tadalafil / CIALIS / NOC

This decision raises an important point as to the meaning of the word “or” in a claim, which I will address in this post. It also raises a variety of issues relating to validity, which I’ll address in my next post. For some reason, the decision is not available on the FC website, so I have linked to a version made available by Smart & Biggar.

The facts are quite straightforward. The 784 patent relates to the use of tadalafil for the treatment of ED. Claim 2, which is representative for present purposes, is to a pharmaceutical composition for the treatment of ED, comprising “[tadalafil] or a physiologically acceptable salt or solvate thereof.” All asserted claims include the phrase “or a physiologically acceptable salt.”

St-Louis J found on the facts that it is not possible to make a physiologically acceptable salt of tadalafil [118]. Tadalafil does not have any ionisable functional groups and consequently it is very difficult to make a salt form [103]. It may be possible to make some salts, but only under extreme conditions that would result in the degradation of tadalafil such that the resultant salt would not be sufficiently pure and stable to be considered physiologically acceptable [118]. As a result, St-Louis J held the 784 patent to be invalid for overbreadth [120] and insufficiency [149]; I’ll discuss the invalidity holdings in my next post.

But what about the “or”? Even though tadalafil salts could not be made, there was no suggestion that tadalfil itself could not be made. If the patentee had eliminated the word “or” by doubling the number of claims, with one set directed to the salt forms, and separate parallel claims to tadalafil itself without the phrase “or a physiologically acceptable salt,” it seems clear that the claims to tadalafil would have been valid. In ordinary English, the word “or” is usually used to link alternatives, so one might think that drafting one claim with “or” should have the same effect as drafting two separate alternative claims.

It seems that Lilly did raise this argument, but too late [78]–[79]. St-Louis J nonetheless went on to briefly address the merits of the argument (citations omitted, original emphasis):

[80] In any event, even assuming that Lilly’s argument is properly before the Court, I find Lilly has not met its burden to demonstrate that the element is non-essential. Claim elements are presumed to be essential and a party alleging otherwise bears the onus of establishing non-essentiality. Also, and given my conclusion on [Lilly’s expert’s] credibility and reliability, the opinion he stated at paragraph 150 of his affidavit alone is insufficient to convince me that the formulation “or a physiologically acceptable salt” means such a salt could or could not be present, and that this element is non-essential. Conversely, [the Defendant’s expert] has found it to be necessary. Since Lilly has not met its burden to establish it is non-essential, I find the “physiologically acceptable salt” to be an essential element of the Asserted Claims.

This strikes me as a strange way of framing the issue. As I see it, the issue isn’t whether the phrase “physiologically acceptable salt” is essential, it is about the meaning of the word “or.” Lilly is not asking the court to read “physiologically acceptable salt” out of the claim, which is normally what happens with an non-essential element. It seems to me that what Lilly really wants is for the court to read “or” to mean “or.” Given that the issue was framed in terms of essentiality, I can't fault St-Louis J's analysis, but, in my view, this obscures the real issue. 

The other point that bothers me is St-Louis J’s reliance on expert evidence as to the meaning of the word “or”. The specification and claims must be construed as they would be understood by a skilled person, but at the same time, “claims construction is a matter of law for the judge”: see eg Whirlpool 2000 SCC 67 [61]. What this means is that expert witnesses must educate the judge as to the meaning of technical terms, but it is for the judge, armed with that knowledge, to decide on how the claim should be construed. The US Supreme Court put it this way in Teva v Sandoz 574 US 318 (2015) 332, quoting Markman  Markman 517 US 370 (1996) 388:

Where technical terms are used, or where the qualities of substances ... or any similar data necessary to the comprehension of the language of the patent are unknown to the judge, the testimony of witnesses may be received upon these subjects, and any other means of information be employed. But in the actual interpretation of the patent the court proceeds upon its own responsibility, as an arbiter of the law, giving to the patent its true and final character and force.

In this case, expert evidence was needed to educate the court as to what is meant by the technical term “physiologically acceptable salt,” but once the judge is armed with that knowledge, the interpretation of the interpretation of the ordinary English word “or” is a matter for the court, and expert evidence on this point is not necessary.

This claim drafting style is very common. If this result stands, it will have a major impact on drafting practice, as patent drafters will have to consider avoiding the word “or” in favour of separate claims, which will be problematic in light of the new excess claim fees. In the meantime, it will create uncertainty. In my view, it would have been much preferable if St-Louis J had rejected the argument on the basis that it had been raised too late, without going on to address it on the merits.

Simultaneous Invention Does Not Necessarily Indicate Obviousness

Betser-Zilevitch v PetroChina Canada Ltd 2022 FCA 162 Locke JA: Stratas, Rivoalen JJA affg 2021 FC 85 and 2021 FC 151 (costs) Manson J

            2,584,627 / Heavy Oil Well Production

There are a few points of interest in Locke JA’s brief decision for the FCA, affirming Manson J decision holding the 627 patent to be valid but not infringed, and dismissing both the patentee’s appeal on the issue of non-infringement and the defendant’s appeal of validity.

As discussed here, Manson J’s conclusion that the defendant’s product did not infringe turned on claim construction, and in particular construction of the term “first level.” A first point is that the parties did not agree on the standard of review. While the arguments weren’t canvassed, I expect the general thrust was that claim construction is a matter for the court, implying it is a question of law, reviewable for correctness; but on the other hand, construction of a technical term turns on what a skilled person would understand it to mean, and so is factually suffused, suggesting a standard of palpable and overriding error. Locke JA stated that “it is not necessary to decide the point. We would dismiss the appeal regardless of the standard of review” [3]. This suggests that the point remains open, though it could just be that Locke JA didn’t want to digress on a matter that didn’t make any difference.

The second claim construction point relates to the long-running debate over whether recourse to the description in interpreting a claim term is always permissible, or if it is permissible only if the term is ambiguous. As discussed here, the point seemed to have been settled in the recent FCA decision in Biogen v Pharmascience / fampidrine 2022 FCA 143 [73] in which Gauthier JA stated unequivocally that “the whole disclosure must be reviewed, even for words that would appear at first glance to be simple and unambiguous when reading only the claims.” The decision under appeal predated Biogen, and Manson J [FC 116–19] had noted the ambiguity in the contentious term, “first level,” before having recourse to the description to construe it. In affirming, Locke JA stated

[5] The Federal Court made no reviewable error in construing the term “first level”. It correctly concluded that the term is ambiguous, and appropriately had recourse to the disclosure of the 627 Patent to construe it.

This might be taken to suggest that recourse to the disclosure is permissible only if the term is ambiguous; if recourse to the disclosure is always permissible, why bother mentioning the Manson J “correctly” found the term to be ambiguous? So it is possible that this is a signal that there is an ongoing split in the Court of Appeal as to whether recourse to the disclosure is always permissible (though Rivoalen JA was on both panels). On the other hand, that may be reading too much into it. Locke JA’s statement is not strictly inconsistent with the view that recourse to the disclosure is always permissible; and on the facts, the term was ambiguous, Manson J did have recourse to the description, there was nothing wrong with that, and Manson J did correctly construe the term in light of the description. My best guess is that Locke JA simply didn’t want to digress on a matter that didn’t make any difference. In any event, even if there is some kind of split at the FCA, so far as the Federal Court is concerned, the clear statement in Biogen is binding until the FCA says otherwise.

On the issue of validity, the appellant pointed to the fact that a third party had made the invention at roughly the same time as being evidence of obviousness, and indeed, as being “primary” evidence of obviousness [9]. (It was not anticipatory as it had not been disclosed to the public.) Locke JA pointed out that “it does not follow that simultaneous invention necessarily indicates obviousness. . . . For instance, the person or persons who conceived the simultaneous invention may have themselves exercised inventive ingenuity in doing so” [9]. This seems to me to be clearly right: when many people are working on the same problem with similar tools, that two of them come up with the same solution may mean the solution is easy, or it may mean that two of the many people working on the problem were clever. It is very helpful to have the point made explicitly, as there isn’t much Canadian caselaw that I know of addressing it directly. Viscount Dunedin made the point in passing in Pope Appliance (1929) 46 RPC 23 (JCPC) 55, stating that “There are many instances in various branches of science of independent investigators making the same discovery,” and the English Court of Appeal in Mölnlycke v Procter & Gamble [1994] RPC 49 (CA) 132, remarked that “The inventive step may not have been large and it is not surprising to us that more than one inventor may have had broadly the same idea at around the same time.” Moreover, the conflict system under the old first-to-invent regime is an implicit recognition of the fact that simultaneous invention is quite common. With that said, while simultaneous invention in itself is not very helpful in establishing obviousness, the actual course of conduct of the other researchers may be useful, in the same way as the actual course of conduct of the inventors themselves: if other researchers arrived easily at the same solution to the same problem, this suggests obviousness, while if the other researchers struggled, this tends to show non-obviousness. However, the actual course of conduct of the other researchers is much less likely to be available.

The Whole Disclosure Must be Reviewed

Biogen Canada Inc v Pharmascience Inc 2022 FCA 143 Gauthier JA: Gleason, Rivoalen JJA affg Biogen Canada Inc v Taro Pharmaceuticals Inc 2020 FC 621 Manson J

            2,562,277 / fampidrine / FAMPYRA / NOC action

            FC Mosaic FC Anticipation FC Medical Treatment

There has been an on-going debate in the case law as to whether recourse to the disclosure is always permissible in claim construction, or is permissible only if the claim terms are ambiguous. In this decision, Gauthier JA has given us a clear and definitive answer (my emphasis):

[73] [T]he point of the [claim construction] analysis is to interpret and respect the inventors’ objective intention as manifested in the words he used. This is why the whole disclosure must be reviewed, even for words that would appear at first glance to be simple and unambiguous when reading only the claims. Indeed, one of the reasons for reviewing the disclosure is to determine whether the inventor actually defines particular words that could appear plain and simple even to a POSITA when reading only the claims.

Gauthier JA again emphasized the point

[71] Although the principles described by the Federal Court are not in dispute in this case, it is still important to reiterate that a patent’s description (also referred to as the disclosure) must be considered when construing claims.

And see [72] stating that “[p]urposive claim construction involves looking at words of the claims in context,” and the relevant context includes the description.

Moreover, Gauthier JA directly applied this principle in her analysis. The specific question was whether terms such as “for improving walking” incorporated a subjective assessment by the patient, or only a quantitatively measured improvement, as Manson J held [75]. While the FCA ultimately upheld Manson J’s claim construction on a deferential standard of review [142], this is not a case where the FCA affirmed the FC claim construction on a holistic appreciation and a deferential standard, perhaps glossing over some details. One of the appellant’s main arguments was that Manson J erred in construing certain contentious terms against what they considered to be conclusive evidence of agreement between the experts [77]. Gauthier JA consequently chose to go into considerable detail on claim construction to illustrate why it can be appropriate for a trial judge to reject expert evidence of how a skilled person would read a claim when that evidence is not supported by a proper application of the principles of purposive claim construction [86], [91]. (This case is also an excellent illustration of the principle that claim construction is a matter for the court.) Consequently, much of Gauthier JA’s discussion reflects the FCA’s own view as to the correct claim construction, not simply the application of a deferential standard of review.

Gauthier JA pointed out that the 277 patent expressly stated that all technical and scientific terms used have the same meanings as commonly understood by one of ordinary skill in the art, “[u]nless defined otherwise,” and indeed, certain specific expressions were given specific definitions [96]. Thus, Gauthier JA’s observation that one must review the disclosure “to determine whether the inventor actually defines particular words that could appear plain and simple” when reading only the claims was directly illustrated in this case. Similarly, she also noted the key contentious terms, namely “use for improving”, “use for increasing” or “use for reducing,” were common words that “[o]n their face . . . appear plain and simple” [82]. She nonetheless went on to consider the description at length [87]–[116], before reviewing the expert evidence and finally arriving at a conclusion on claim construction [142].

It is somewhat unfortunate that Gauthier JA did not refer to the debate over this point, but she cannot have been unaware of it. And this is not a situation where there was some clear and unambiguous statement from the FCA to the effect that recourse to the disclosure is impermissible unless the claim terms are ambiguous; rather, the debate has arisen because of a variety of ambiguous statements by the FCA: McHaffie J provided a thorough review of the cases in Guest Tek 2021 FC 276, discussed here. The point was also raised in Google v Sonos 2022 FC 1116 [40], released just a week after this decision. In that case, Zinn J reviewed the recent FC caselaw and agreed with McHaffie J that “[t]he exercise of construction must consider both the disclosure and the claims” [42]–[44]. Thus, there was already a consensus emerging at the FC level, which is consistent with the position stated by Gauthier JA. The key point is that recourse to the disclosure is always permissible, but “[t]he disclosure should not be used to enlarge or contract the scope of the claims, particularly through the addition of words or limitations not found in the claims” [42], quoting and agreeing with Guest Tek [47]. In the circumstances, I take it that Gauthier JA did not review the caselaw because she was of the view that the point was not sufficiently controversial to warrant it. In any event, given the very clear statement of principle, combined with its application to the facts, we can now take it as settled law that in carrying out claim construction, “the whole disclosure must be reviewed, even for words that would appear at first glance to be simple and unambiguous when reading only the claims.”

Obviousness

After affirmed Manson J’s holding on claim construction, the FCA went on to affirm on his finding that the asserted claims were invalid for obviousness [170]. In my post on Manson J’s decision on this issue, I suggested that his analysis was notable for making a mosaic of obscure prior art. This issue was not raised at the FCA. I’ll discuss it further in my upcoming post on Google v Sonos 2022 FC 1116, which raises the same issue.

Anticipation

Manson J also held the 277 patent invalid for anticipation, noting that the key anticipatory prior art “is similar to the allegedly anticipatory art in Hospira [2020 FCA 30]” [133]. As discussed here, I had several concerns regarding the implications of Hospira, as reflected in Manson J’s analysis. It is therefore noteworthy that Gauthier JA declined to address anticipation:

[172] As mentioned, there is no need to discuss the Federal Court’s findings in respect of anticipation, nor is this the proper case to address in obiter the question of how Hospira Healthcare Corporation v Kennedy Trust for Rheumatology Research, 2020 FCA 30 (Hospira) and the Federal Court’s conclusion on anticipation might have an impact on inventions requiring investments in large clinical trials, as briefly argued.

[173] That said, it is important to recall that nothing in these reasons or my conclusion that the appeal should be dismissed, should be understood as endorsing the conclusion of the Federal Court on anticipation. Also, neither this Court in Hospira nor the Federal Court intended to modify the well-established test enunciated in Sanofi (FC Decision at paras. 114-115).

Nor did Gauthier JA discuss Manson J’s holding that none of the asserted claims were invalid as covering unpatentable methods of medical treatment [FC 214], discussed here, as the issue was not raised before the FCA [33].

Skinny Label and Swiss Claims

Janssen Inc v Apotex Inc 2022 FC 996 (reasons) 2022 FC 995 (judgment) Pallotta J

            2,659,770 / macitentan / OPSUMIT / NOC

There are three known biological pathways affecting pulmonary blood pressure, namely the prostacyclin, nitric oxide, and endothelin pathways. PDE5 inhibitors, such as tadalafil, work through the nitric oxide pathway. Macitentan is an endothelin receptor antagonist (ERA), which, as the name suggests, works through the endothelin pathway. The 770 patent relates to the use of combination therapy consisting of macitentan and a PDE5 inhibitor (PDE5-I) to treat diseases involving vasoconstriction, particularly pulmonary arterial hypertension (PAH). Most PAH patients are treated with combination therapy, but a non-trivial number of patients — around 20% — are treated with macitentan monotherapy [162]. Janssen markets OPSUMIT, a 10 mg tablet, for use alone or in combination therapy. Apotex sought to market a 10mg tablet of macitentan, which is not itself patented, and in this NOC action, Pallotta J held that Apotex’s macitentan product would infringe Janssen’s 770 patent. Validity was not at issue [9]. The 770 patent was also at issue in Janssen v Sandoz 2022 FC 715, in which infringement was conceded and validity was at issue: see here.

This is in many ways a typical ‘skinny label’ case, in which a generic seeks to sell a drug that is itself unpatented, but which may be used in a manner that is patented, eg as part of a patented combination, or for a patented indication. The generic in such cases is not normally a direct infringer, so infringement by inducement must be established under the three-part Corlac test, 2011 FCA 228 [162]. This typically reduces to the question of whether the generic’s product monograph (PM) will induce infringement by prescribing physicians, who will read the monograph and thereby be induced to prescribe the generic product for use in an infringing manner. A central question is therefore whether the generic’s skinny label has been sufficiently scrubbed clean of any reference to the infringing use. This inquiry turns on the details of the PM. Sometimes the generic wins, sometimes it loses—as in this case. The generic will also sometimes argue that even if its PM does instruct an infringing use, that doesn’t constitute infringement because the prescribers don’t pay any attention to the generic PM in any event. Whether prescribers heed the generic PM is a fact-specific inquiry, but so far as I know, no generic has ever prevailed on this argument. (Please leave a comment with a case cite if I am wrong about that.) Apotex made that argument in this case, and, unsurprisingly, lost. The result was that Apotex was enjoined from marketing Apo-macitentan until after the expiry of the 770 patent. While the case was typical in broad outlines, there are a few issues of interest in this decision, particularly on the construction of Swiss-type claims.

Three types of claims were at issue in this case [86]:

Product for use

Claims 1–5 eg “A product containing [macitentan] . . . in combination with [a PDE5-I] . . . for therapeutic use. . . in the treatment of [PAH].”

Use for treatment — sometimes referred to as German-style claims

Claims 21–31 eg “A use of [macitentan] in combination with [a PDE5-I] for treating [PAH].”

Use in manufacture of a medicament for — commonly called Swiss-form claims

Claims 10–20 eg “A use of [macitentan] in combination with [a PDE5-I] . . . for the manufacture of a medicament intended to treat [PAH].

A variety of claim types are employed because many jurisdictions have some kind of prohibition on patenting of methods of medical treatment, and consequently a variety of claim forms are used in claiming the use of a compound to treat a disease. A fourth type of claim that is often used in the US is straightforward: “A method of treating disease Y, comprising administering compound X.” This type of claim is not allowed in Canada as it is considered to fall afoul of the prohibition on patenting methods of medical treatment.

A preliminary issue was as to the construction of “combination,” which Pallotta J construed as including any scenario in which macitentan and the PDE5-I work in concert to treat the disease in question. In particular, it does not matter whether the macitentan and PDE5-I are combined in the same dosage form [120]; and it includes a scenario in which the patient is started on macitentan monotherapy and then moved to a combination therapy of macitentan and PDE5-I [116].

The most interesting claim construction issue concerned the interpretation of the Swiss-type claims. Swiss claims were originally developed to avoid the European prohibition on patenting of methods of medical treatment. Since a Swiss claim is, on its face, a claim to the product, not its use, and the physician who prescribes a drug does not manufacture it, physicians are excluded from the scope of infringement. However, in Hoffmann-La Roche v Sandoz 2021 FC 384, [95]–[109], Manson J held that the Swiss claims should be construed as use claims on the basis of a purposive interpretation; in effect, the idea is that what was really discovered was a new use, not a new method of manufacture, and the claim should be construed in light of what was actually discovered [97]. The result was that the generic, Sandoz, could not be liable as a direct infringer. As discussed here, this is a bit of a strange result, because it means that prescribers are direct infringers and the manufacturer is not, even though the original purpose of Swiss claims was to ensure that the manufacturer a direct infringer and the prescriber is not an infringer at all.

In this case, Apotex, relying on Hoffmann-La Roche, argued that the Swiss claims should be construed as use claims, so that Apotex could only be liable, if at all, on the basis of inducement. Pallotta J did not accept this argument. While a purposive construction may consider the nature of the inventive concept, “a purposive construction focuses on the language of the claims,” and “[t]he words chosen by the patentee necessarily play a key role” [128]. The importance of the text is consistent with the general law of statutory interpretation: Canada Trustco 2005 SCC 54 [10]; Canada v Utah 2020 FCA 224 [9]; Biolyse v Bristol-Myers Squibb 2003 FCA 180 [13]. It is also well-established as a principle of claim construction: Free World 2000 SCC 66 [39]–[40]; ABB Technology 2015 FCA 181 [42]–[43] (cited by Pallotta J at [128]. The words of the Swiss claims clearly claim the use “for manufacture of a medicament” [128].

While I’ve waffled a bit on this (see my comments on Warner-Lambert) I think Pallotta J is right on this. The key doctrinal point is that the words play a “dominant role” in the interpretive process, as the SCC put it in Canada Trustco. This is important in the context of statutory interpretation because the legislature must be able to rely on the courts to carry out the legislature’s intent, and the words, when clear, are the best reflection of that intent. The parallel point in the context of claim construction is that the patentee should be able to decide what it wants to claim—taking the risk that the claim may be invalid—and again, the words it uses are the best guide to that intent. If there is some public policy reason that Swiss form claims should not be permitted at all, then this should be implemented through a substantive legal rule, which can then be debated and subject to appeal.

Even though Pallotta J came to a different conclusion than Manson J, she did not have to expressly disagree with his analysis, as Manson J held that the meaning was context specific [103] and his holding of law was only that Swiss claims do not “automatically benefit[] from a literal construction” [102]. I must say I am not very enthused about that approach. Patent agents take great pains with the words used in a claim. While some terms used will be specific to the invention, and so may require considerable context, there are some terms, such as “comprising,” which are effectively terms of art with a specific meaning, and which should accordingly be given a consistent meaning. To my mind, Swiss claims are sufficiently common and established as a claim form, that they should be given a standard construction, so that patent agents will be able to predict the consequences of using Swiss claims.

Even though Palotta J construed the Swiss claims as product claims, she nonetheless held that neither the Swiss claims, nor the product-for-use claims, were directly infringed by Apotex. She noted that Apotex only intended to sell macitentan itself, not a product that contains macitentan in combination with a PDE5-I. Consequently, she held that Apotex did not infringe the product-for-use claims, which claim ‘A product containing [macitentan] in combination with [PDE5-I]’ because the product sold by Apotex would not contain the drugs in combination [144]. This reasoning seems right to me. She held that the Swiss claims were not infringed for the same reason [144]. This also seems right, given the structure of the Swiss claims at issue: “A use of [macitentan] in combination with [a PDE5-I] . . . for the manufacture of a medicament intended to treat [PAH].” This indicates that macitentan and the PDE5-I are used in combination for manufacture of the medicament.

As an aside, it occurs to me that a more difficult question would arise if the Swiss claims were of the form “A use of [macitentan] for the manufacture of a medicament intended to treat [PAH] in combination with [a PDE5-I].” In that claim, the question is whether the macitentan is intended for combination use, which, given Pallotta J’s holding that “in combination” encompasses any scenario in which the drugs work in concert, would include administration of separate pills in combination therapy. In that hypothetical, the question would be whether the generic product was intended for use in combination therapy. As discussed here, in Warner-Lambert v Generics (UK) [2018] UKSC 56 the UKSC split three ways in trying to decide what “for” means, with two variations on an objective intent test, plus a subjective intent test, not to mention the modified objective foreseeability test endorsed by the EWCA. Using the hypothetical claim, the generic might be a direct infringer on either the objective or subjective intent approach, depending on whether, on the facts, it subjectively or objectively intended macitentan to be administered in combination with a PDE5-I. I would stress that I am not endorsing either of these approaches, but simply pointing out that a more difficult issue would have arisen had the Swiss claims been framed differently.

With construction settled, Apotex argued that its PM did not instruct the use of macitentan in combination therapy. Pallotta J rejected this argument on the facts. It’s a bit hard to follow because of redactions, which, though brief, obscure the precise nature of the references. If I understand correctly, the main trial which established the safety and efficacy of macitentan as a monotherapy – “SERAPHIN” — also established its efficacy as a combination therapy [153]. The Apotex PM contained clinical trial data from SERAPHIN [192], [193], and SERAPHIN was so well known [187] that the references to it in the Apotex PM would be enough to alert physicians to the fact that macitentan is effective in combination therapy, and so would induce infringement [192], [199]. This is even though the APO-MACITENTAN PM “removed all mentions to the use of macitentan as a combination therapy that are present in the OPSUMIT PM, and only mentions SERAPHIN results that reported macitentan was useful as a monotherapy” [164]. It is true that the courts have been stringent about ensuring that the generic PM is scrubbed clean of references to the infringing use, but this seems pretty harsh on Apotex, given that it had to include the clinical trial data to establish efficacy as a monotherapy. I must say that I suspect that one factor in Pallotta J’s analysis is the fact that combination therapy is the primary use for macitentan, with only 10–30% of patients getting monotherapy [162]. If the opposite were true, so that eg only 10% of the use was in the patented combination, then I wonder if it would have gone the other way. Of course, in that scenario, it is perhaps unlikely that the main clinical trial data would be for the combination therapy.

Apotex also argued that even if the PM did instruct infringing combination therapy, this did not matter because prescribers don’t pay attention to the PM anyway: “In the field of PAH, the physicians know SERAPHIN very well and it does not matter what is contained in APO-MACITENTAN PM” [166]. This argument failed on the facts [197], as it always does. (If anyone knows a case where this argument has succeeded, please let me know in the comments.) The argument makes sense in theory, given the requirement that the influence be the “but for” cause of direct infringement, but if successful, it would mean that generic would in theory be able to sell a drug with the infringing use plastered all over the PM, on the basis that the PM is irrelevant anyway. I suspect that a desire to avoid this strongly counter-intuitive result might help explain why the courts invariably come to the conclusion that at least some prescribers are influenced by the PM. (Of course, it’s also possible that it’s simply true that at least some prescribers are influenced by the PM.)

Finally, Pallotta J emphasized that in light of this influence, Apotex would induce infringement “even if a physician applies their own skill and judgment to the decision to prescribe combination therapy” [156]: see similarly [181]. Pallotta J remarked that “[i]f it were otherwise, inducing infringement could never be found in the context of pharmaceutical patents” [156]. In any event, I don’t really see any difficulty with this position. As Pallotta J also noted, “a ‘but for’ test does not mean that Apotex’s activities must be the sole cause of the infringement” [156]. A physician who learns from the PM that macitentan is useful in combination therapy to treat PAH must still use their skill and judgment to determine that their patient is suffering from PAH. Conversely, a physician who has determined that their patient is suffering from PAH will not prescribe macitentan combination therapy unless they have learned somewhere that it is effective in treating PAH; and if they learn that from the PM, the information in the PM is the ‘but for’ cause of the infringement, even if it is not the sole cause of the infringement.

What Does “For” Mean?

Allergan Inc v Apotex Inc 2022 FC 260 Kane J

2,602,188 / risedronate / ACTONEL DR

As noted in my last post, the 188 patent at issue in this case claims a dosage form of a bisphosphonate “for use with or without food” in treating osteoporosis. The product monograph for Apotex’s product—like Allergan’s—provided that it was to be taken with food. Consequently, Allergan argued that “for” product claim is normally construed as meaning “suitable for”, relying on MacOdrum, Fox 5^th ed ch 8.9(c) (§ 8:57 in 2/2022 update I have) and cases cited therein [182], [901]. The idea is that Apotex’s product is suitable for administration with or without food, in the sense that it would be effective in treating even if, in light of the product monograph, it are not intended for that purpose. Kane J rejected this, essentially on the basis that even if “for” is normally interpreted as “suitable for”, that is not strict rule, but rather, as MacOdrum notes, it is at best a generalization that should be cautiously applied [903]. Instead, as discussed in my last post, she held that in the context of the 188 patent, “for” should be construed as effectively meaning ‘intended for’. That’s enough to dispose of the point in this case, but since I read a number of cases on the interpretation of “for”, in this post I will discuss the issue more broadly.

The cases reveal a few possible meanings for “for”:

(1) suitable for;

            (2) actually used for;

(3) intended for;

            (4) suitable and intended for.

I’ll argue that many of the authorities cited for the proposition that “for” means ‘suitable for’, actually stand for the proposition that “for” does not mean ‘actually used for’. Such holdings are not inconsistent with construing ‘for’ as meaning ‘intended for’ or ‘suitable and intended for.’ While I did not exhaustively review the cases, the cases I did read can largely be reconciled by interpreting ‘for’ as meaning ‘suitable and intended for.’

There does not appear to be much Canadian authority explicitly addressing the meaning of “for” (though there are of course many Canadian cases construing claims with “for” in them). All of the authorities cited by MacOdrum are English. The conventional view in UK law is that “for” means ‘suitable for’, with an exception for second medical use claims, where “for” means ‘intended for’: see Virgin v Delta [2011] EWCA Civ 162 [19]–[23], providing a list of cases; FNM v Drammock [2009] EWHC 1294 (Pat) [56]-[74]; EPO Guidelines § 4.13.1. The second medical use exception is explained as an ad hoc departure from the general rule because of the need to allow second medical use claims: see FNM [2009] EWHC 1294 (Pat) [60]–[72]; EPO Guidelines § 4.13.1 last sentence.

As noted in Zeno [2009] EWHC 1829 (Pat) [26], the origin of the rule appears to be Adhesive Dry Mounting v Trapp (1910) 27 RPC 341 (Ch) 352–53. In Adhesive Dry Mounting, the question is whether “for” should be construed as meaning ‘suitable for’ or as meaning ‘when actually used for.’ The claim was “For carrying into practice the process [specified] a pellicle [as specified]” and the question was

whether it claims the pellicle therein described, or merely the use of this pellicle in the process claimed in the first Claiming Clause. If the former, the Letters Patent would entitle the Patentees to prevent the use of such a pellicle by others, whatever might be the purpose for which it was used. If the latter, the Letters Patent would only entitle the Patentees to restrain the use of such a pellicle in any process substantially the same as the process referred to in the first Claiming Clause.

Parker J chose the former construction, in part because another claim was to the process, and the claim at issue would be largely redundant if it was to the pellicle only when used in the process. Of the cases listed in Virgin v Delta, Insituform v Inliner [1992] RPC 83 (Pat) 95–96, Coflexip v Stolt [2000] EWCA Civ 242 [23]–[27] and Vericore v Vetrepharm [2003] EWHC 1877 (Ch) [15] were also cases in which the question was also whether “for” should be construed as meaning ‘suitable for’ or as meaning ‘when actually used for,’ and in all cases the court held “suitable for” was correct. I have not read any case in which “for” on its own was construed as meaning ‘when actually used for’ and this point seems well-established, at least as a strong presumption.

Every case must be read in light of the arguments before the court, and cases holding only that “for” should be construed as meaning ‘suitable for’ rather than ‘actually used for’, are not good authority for the proposition that it should be construed as meaning ‘suitable for’ rather than ‘intended for.’ The caselaw is more equivocal on the whether “for” means ‘suitable for’, or ‘intended for’—or perhaps even ‘suitable and intended for’. This was acknowledged by the EWCA in Virgin v Delta at [23], in which Jacob LJ noted that “in Zeno Lewison J seemed a little sceptical about this rule of construction. He wondered, having only been shown Adhesive Dry Mounting and Coflexip, whether for might not be construed as intended for at least in some cases depending on the specification as a whole.” The EWCA went on to note that in second medical use cases it usually does mean ‘intended for’, and then remarked that “even then the claim would mean suitable and intended for” [23]. The EWCA did not explore the possibility further, as it made no difference on the facts.

The EPO Guidelines § 4.13.1 does say that “for” means ‘suitable for’, but the main point is that an apparatus which is not suitable for the stated purpose “is normally not considered as anticipating the claim.” It is sensible to say that a claim “for” some purpose does not encompasses a thing that is unsuitable for that purpose; but that does not imply that “for” means ‘suitable for’. In particular, that view is also consistent with construing “for” as ‘suitable and intended for.’ (There is a separate question as to what ‘suitable for’ means–see eg Bühler v Satake [1997] RPC 232, 239-240—and much of the discussion in MacOdrum is taken up with this point.)

If “for” means ‘suitable and intended for’, both terms play a role. A device that is intended for the claimed purpose but is not suitable for it, would neither infringe nor anticipate. That much seems uncontroversial. A device that is suitable for the claimed purpose would not infringe unless also intended for that purpose. Leaving aside medical use claims for the moment, would a product or apparatus that was suitable for a particular use, but not intended for that use, anticipate a claim to the product or apparatus for that particular use, if the use of the product for that purpose was new and non-obvious? The EPO Guidelines § 4.13.1 say it would—“if the known product is in a form in which it is in fact suitable for the stated use, though it has never been described for that use, it deprives the claim of novelty”—but cites no cases. Moreover, the Guidelines then go on to acknowledge that a claim to a known substance for medical use is an exception—an exception which largely swallows the rule. And as a matter of principle, if disclosure of a compound does not anticipate a claim to the use of that compound for a medical use, why would it anticipate a claim to the use of that compound for a non-medical use? If Compound X is known in the prior art, but no uses are known, it is a bit odd to say that a claim to “Compound X for use in treating psoriasis” is valid, but “Compound X for use as a herbicide” is invalid. Drawing a distinction between a compound and a device seems similarly unprincipled.

This point was tangentially addressed in Adhesive Dry Mounting. Parker J held at 353 that “for” was to be interpreted as meaning ‘suitable for’ and consequently, he held that the claim was anticipated by a prior art patent which disclosed the same type of pellicle, even though the prior art did not suggest that it could be used for the specified purpose:

But after [the prior art patent] it was open to all the world to make and sell such a material. The idea of using an old material for an entirely new purpose, not being analogous to purposes for which it has theretofore been used, may be good subject-matter, but such idea, however ingenious, can hardly justify a claim for the material itself.

But if “for” is construed as ‘suitable and intended for’, then a claim to an old material for a new use is not a claim to the material itself. Parker J seems not to have contemplated the possibility that it might be construed to mean ‘intended for’.

While second medical use claims are now well-established, second use claims more generally are also established, though less common in practice. In the well-known cases of Hickton's Patent (1909) 26 RPC 339 (CA), cited with approval in Shell Oil [1982] 2 SCR 536, 550, the invention was for a method of equalizing thread usage on lace making machines. Some sections of lace are thick with thread while others are quite open, with the result that some bobbins would use up their thread more quickly than others. Equalization had previously been accomplished by interchanging the bobbins by hand, but this saved thread only by wasting time. Hickton’s invention was to equalize by occasional “shogging” or sideways shifting of the bobbins relative to the carriers, so that a bobbin initially used for a thick part of the pattern would be shifted to a more open section. Shogging itself was not new, as it was used in some types of machines to create the lace pattern itself. Hickton’s innovation was to realize that shogging could be used to equalize thread usage. Claim 1 was to shogging “for the purpose of” equalising [thread consumption], and Claim 2 was to a “means” for the same purpose; in other words, to an old process and old device for a new purpose. These claims were held to be valid.

Zeno [2009] EWHC 1829 (Pat) also raises the issue. The patent claimed a device “for the local thermal treatment of insect stings” by means of heat. The allegedly infringing ‘Zeno’ device was for the treatment of acne by means of the application of heat, with a specified temperature range and time interval. The argument was that the Zeno infringed because it was suitable for the treatment of insect stings, even though it was not intended for that purpose. In the circumstances, it is understandable that Lewison J expressed skepticism of the rule that “for” should be interpreted as ‘suitable for’. While he was “content” to proceed on that assumption, he found that the Zeno was non-infringing because it was not capable of being operated within the specified range and time interval [59]–[65]; we should not infer that he would necessarily have been content to accept that construction if it had affected the outcome.

I note that in Corevalve v Edwards Lifesciences [2009] EWHC 6 (Pat) Mr Prescott QC, stated that “if a piece of prior art is as a practical fact capable of being used for a certain purpose, it may anticipate a patent claim even though it would never occur to anyone so to use it,” citing Adhesive Drive Mounting as an example, and citing no other authority. I suppose it is true to say that a product suitable for a purpose “may” anticipate a claim for that purpose, but it would be wrong to say that it “will” anticipate, as Hickton’s Patent illustrates. As discussed, Adhesive Drive Mounting is weak authority, as it does not consider whether intend might be relevant to a claim “for” a purpose, but simply assumes that it is equivalent to a claim to the product itself. And the discussion in Corevalve was merely preliminary dicta in any event; the defendants device was not only suitable for, but also intended for, the specified purpose, and it was held not to infringe because it did not incorporated an entirely separate element [62]–[65].

To summarize, the cases I have looked at are generally consistent with construing ‘for’ as meaning ‘suitable and intended for.” In Delta v Virgin, for example, the claim was to a passenger seating system “for an aircraft” and the question was whether this encompassed the defendant seating system kits, prior to their actual installation; the EWCA held that it should, on the view that a system “for an aircraft” should be construed as meaning a system suitable for an aircraft, and not as being limited to a system when actually fitted on an aircraft [24]. There was no question that the defendant’s system was intended for use on an aircraft. In FNM v Drammock [2009] EWHC 1294 (Pat) the claim was to a composition for use as a cooling spray [20]. Arnold J construed this as meaning suitable for use as such, but this does not appear to have made any difference to his conclusion that the invention was anticipated, as the anticipatory prior art expressly identified use as a cooling spray, or gave examples to that effect—see [170], [175], [180], [184].

Finally I’ll come back to medical use claims. Three of these were raised in argument, namely Sanofi-Aventis v Novopharm / ramipril 2007 FCA 167, AB Hassle 2001 FCT 1264 affd 2002 FCA 421, and Bristol-Myers Squibb 2017 FC 1061. Kane J distinguished AB Hassle by saying the claims

[878] are not similar to the claims at issue. As noted by the Court, there were no claims for the compound, unlike the present case. The claim at issue in AB Hassle was only the use to treat a condition previously not claimed as a use. AB Hassle dealt with the more typical scenario of a claim for the new use of an existing compound or product.

The discussion of the other two cases was to a similar effect. As I understand it, Kane J’s point is that these are not simply claims to a compound “for” a particular purpose, but claims to the “use. . . for”. (Claim 1 of the 668 patent in AB Hassle and Claim 1 of the Bristol-Myers Squibb 496 patent were Swiss-from to “Use of [compound] for the manufacture / production of a medicament for / effective in the treatment of [specified disorder]. Claim 1 of the Ramipril 089 patent was to a compound “for administration”, which is similar to a use claim.) So, while “for” might be interpreted as ‘suitable or intended’, the “use” or “administration” elements additionally implies actual use. This seems right to me. If “use. . . for” merely meant ‘suitable for’ or ‘suitable and intended for’, a generic selling a drug for the specified purpose, in the sense that the product monograph specified the claimed purpose, would be liable as a direct infringer; but this situation is invariably treated as a matter of inducement, which implies the actual use constitutes the direct infringement.

In any event, I’ve gone on much longer than I had intended on this point, given that Kane J’s holding ultimately turned on her construction of the specific patent, which, as noted in my previous post, is in an somewhat unusual form. I won’t go on to review every case I looked at in detail, and in any event, I didn’t attempt to track down all the relevant cases. What I will say is that the cases I did review are consistent with construing “for” as meaning ‘suitable and intended for.’ This interpretation of “for” has the advantage that second medical use claims need not be seen as an unprincipled outlier, though subject to the observations about the meaning of “use”.

Direct Infringement and Swiss-Form Claims

Hoffmann-La Roche Limited v Sandoz Canada Inc 2021 FC 384 Manson J

2,667,654 / 2,709,997 / pirfenidone / ESBRIET / NOC

Roche’s 654 and 997 patents at issue in this NOC proceeding relate to the use of pirfenidone in the treatment of idiopathic pulmonary fibrosis [IPF]. As discussed in my last post, Manson J held that the asserted claims of both patents were invalid for obviousness and as being methods of medical treatment. This post will address Manson J’s construction of the Swiss-type claims.

The 654 patent claimed a dose escalation regimen, while the 997 patent claimed full dose treatment of a patient who had exhibited liver abnormality after initial treatment. The details of the claims don’t matter for present purposes. Both patents had three distinct claim types [95]–[96]:

            1) “German-style” — “Use of [drug] for treatment of [disorder]

2) “Swiss-style” — “Use of [drug] in the manufacture of a medicament for treatment of [disorder]

3) “Product for use style” — “[Drug] for use in the treatment of [disorder]

Sandoz argued that “Swiss-style claims do not apply in Canada and are properly construed as ‘use’ claims where the alleged invention resides in the use and not in the manufacture or composition of the medicine” [96]. Roche apparently argued that there is a substantive distinction between the claim types, such that Sandoz would be a direct infringer of the Swiss-style claims. (Manson J did not expressly state Roche’s argument.)

Manson J rejected Roche’s approach, saying it “seeks a finding of claim form over substance. In doing so, it obscures the proper approach to claims construction. As discussed above, the claims construction exercise emphasizes a purposive construction” [97] (original emphasis); and similarly, the case law “supports an approach to claims construction which values substance over form” [107].

With respect, it’s not quite right to say that a purposive approach focuses on substance over form—though in saying that, I have to admit that in a previous post on the UKSC decision in Warner-Lambert v Actavis [2018] UKSC 56, I made comments about Swiss-form claims that were very much along the same lines as those as Manson J in this case, so the extent that I am disagreeing with Manson J’s analysis, I am also disagreeing with myself. In any event, the principles of statutory interpretation apply to claim construction by virtue of the Interpretation Act: Whirlpool 2000 SCC 67 [49(e)]. Those principles require consideration of text, context and purpose: Canada Trustco 2005 SCC 54 [10]; Canada v Utah 2020 FCA 224 [9]. Purpose is one consideration, but primacy is given to the text, both in statutory interpretation generally—“When the words of a provision are precise and unequivocal, the ordinary meaning of the words play a dominant role in the interpretive process”: Canada Trustco 2005 SCC 54 [10]— and in claim construction in particular, where “The primacy of the language of the claims was emphatically affirmed in the celebrated case of Catnic Components Ltd. v. Hill & Smith Ltd., [1982] R.P.C. 183 (H.L.)”: Free World 2000 SCC 66 [39]. Thus the purpose and context inform our understanding of the text, but the focus is on the text itself. A purposive analysis may in principle result in some part of the text effectively being read out of the claim, but this is rare in practice and is only done after an explicit essentiality analysis, which was not at issue here.

The main purposive consideration relied on by Manson J was to the effect that the inventive concept was the dose escalation regime: “there is nothing novel about the manufacture or composition of pirfenidone to treat IPF in this case, but only a new dosing regimen of pirfenidone for use in the treatment of IPF” [103]; “The alleged invention in this case resides in the use of pirfenidone, whether in the context of the 654 or 997 Patent, and not in the manufacture or composition of pirfenidone, a known compound” [97]. That’s true enough, but it doesn’t imply that the claim should be construed as a use claim. Manson J’s analysis almost seems to imply that a patentee is restricted to a claim form that directly reflects the inventive concept, and that has never been the law. A claim that does not encompass the inventive concept will normally be invalid for obviousness or anticipation, but there is no general prohibition on adding other elements that narrow the scope. For example, if an inventor discovers a new medical use for a known compound, the inventive concept lies in the discovery of the use. While the patentee will normally claim the use to treat the disorder, the patentee may also claim the product for use in various forms, such as a tablet, capsule, injectable form and a form for parenteral administration, even though none of the various forms involves an additional inventive step. Manson J also referred to the experts’ understanding of the claims expert understanding of the claims as relating to a dose escalation regimen [91], [97]. In effect, they understood the claim as being addressed to the inventive concept. But claim construction is for the court, not the experts, and the fact that a scientific expert ignored the text does not mean that the court should do so.

Why does it matter? Two substantive points are engaged. The Swiss-form claim was originally developed to avoid the European prohibition on patenting of methods of medical treatment. A Swiss claim is to the use of the drug “in the manufacture of a medicament,” and since the physician who prescribes a drug does not manufacture it, on its face, physicians are excluded from the scope of infringement. The rationale currently offered by Canadian courts for the prohibition on patenting methods of medical treatment is to ensure that the patent does not impede the physician in their treatment of their patients, so if Swiss-form claims were successful in excluding physicians from the scope of the claim, it would certainly be a point of substance. However, as the EWCA pointed out in Warner-Lambert v Actavis [2015] EWCA Civ 556 [54], the Swiss-form claim is probably not effective in excluding doctors from the scope of the claim: “As the claim is a process claim [under s 60 of the Patents Act 1977], its direct product, the medicine, is an infringement, and all those who use or dispose of the product will infringe.” The same appears to be true in Canadian law, in light of the Saccharin doctrine: see Hospira 2018 FC 259 [328]. The basic problem is that if a Swiss-form claim is infringed only by the actual manufacturer, then a generic could escape infringement of a Swiss claim by manufacturing abroad (as was argued, and rejected, in Hospira); but since Swiss claims are construed as encompassing the product of the patented process, it follows that the sale and use—including by physicians and patients—will also infringe. The lesson here seems to be that the problem of patentability of methods of medical treatment is not going to be solved by clever claim drafting.

But there is another aspect to Swiss claims. If construed as a claim to the process of manufacture and not solely as a use claim, then the manufacturer would be a direct infringer. This is entirely aside from the issue of whether those who use the product are infringers as well. In this case, the result of Manson J construing the Swiss claim—on its face a process claim—as a use claim, is that even though Sandoz evidently used the process, by manufacturing a medicament for the claimed purpose, it was not liable for direct infringement of the Swiss claim, “as it does not and will not use the Sandoz Products in the treatment of IPF” [108]. That is, the original purpose of Swiss claims was to exclude physicians from the scope of the claim, so that only the manufacturer would be a direct infringer. If Swiss claims are construed as use claims, the result is that the manufacturer is excluded from the scope of direct infringement, while physicians are encompassed—effectively the opposite of the original intent.

Roche therefore was confined to an argument in indirect infringement, which requires (i) direct infringement; (ii) inducement by Sandoz; (iii) knowledge by Sandoz. The direct infringement is that of the physicians and patients, and the knowledge requirement is only that Sandoz knows that its actions will result in direct infringement. The first and third elements will normally be readily established in any case in which the generic makes and sells a product with indications for the specified use, as happened in this case: [142], [123]. The real difference between direct and induced infringement lies in the second requirement. The main issue in this case, as is typical, is whether prescribing physicians read and are influenced by the Product Monograph which directs an infringing use [124]–[141]. If the Swiss claims were construed as process claims, then Sandoz would have been a direct infringer, and it would not have been necessary for Roche to establish that the physicians read and were influenced by the PM. Because the the Swiss claims were construed as use claims, Roche was required to prove that physicians do actually read the Sandoz PM. In this case, Roche was able to establish that at least some phyusicians would consult the Sandoz PM [140], so indirect infringement was established, albeit with an extra evidentiary hurdle.

So, construing the Swiss claims as use claims means that a generic that made and sold a drug intending it to be used for the patented purpose, and which was in fact used for the patented purpose, will not be liable unless the patentee can establish that the physicians read and were influenced by the generic PM. If the facts establish that physicians read the brand PM and rely on their knowledge that the generic product is equivalent, without actually being influenced by the generic PM, the generic will be able to make and sell the drug for the patented use.

As a practical matter, the patentee is usually able to prove that the physicians were influenced by the generic PM, so the result is only to add cost and complexity without changing the result. This would be acceptable if there were some good reason of policy or principle for enabling the generic to escape liability if the physicians rely on the brand PM instead of the generic PM; but I have considerable difficulty seeing any good reason for restricting the scope of infringement in that manner. The requirement of influence makes good sense when the product has a substantial non-infringing use, to ensure that the defendant is not prevented from selling the product for non-infringing uses: see generally Contributory Infringement in Canadian Law (2020) 35 CIPR 10. But why should a generic be permitted to sell a product which it specifically intends should be used to infringe, and which is in fact used to infringe, simply because the physician relies on the brand PM and equivalency, instead of reading the generic PM? In effect, construing the Swiss-type claim as a use claim introduces a substantive limitation on the scope of infringement. Perhaps there is some good policy reason for it, but if so, it should be directly articulated. I have a draft paper “Is 'But For' Causation Necessary to Establish Inducement?” arguing that the law of inducement should be clarified to avoid this result. Unless it is, the construction of Swiss-form claims will remain significant even if the confusion over patentability of methods of medical treatment is eventually resolved.

Can the Scope of the Claim Grow Over Time?

Merck Sharp & Dohme v Wyeth 2021 FC 317 Gagné ACJ

2,604,363 / 2,650,056 / 2,803,111 / pneumococcal polysaccharide protein conjugate vaccine / PREVNAR 13

Wyeth’s 363 patent relates to a pneumococcal polysaccharide protein conjugate vaccine that is effective against 13 serotypes. The 056 and 111 patents are related formulation patents. Merck was concerned that Wyeth would use its patents to block the Merck V114 vaccine, which is effective against 15 serotypes [5], and accordingly brought this impeachment action. A key issue was therefore whether the 363 patent, in particular Claim 1, was limited to 13 serotypes [49]. This turned on what strikes me as a tricky issue of claim construction.

As I understand it, capsular polysaccharides are the major components on the surface of bacteria. Different serotypes have different polysaccharide cell-surface antigens. A protein conjugate vaccine is a substance that is composed of a polysaccharide antigen fused (conjugated) to a protein carrier molecule. The protein carrier substantially enhances the immune response. It is desirable to have as many different serotypes as possible covered by a single vaccine, and since 2000, efforts have been underway by various parties to develop protein conjugate vaccines that are effective against multiple serotypes. The first, released by Wyeth in 2000, was effective against 7 serotypes [17]. This was subsequently bumped up to 9 by Wyeth, 11 by DSK and Aventis, then 13 by Wyeth and now 15 by Merck [18]–[21]. Wyeth’s favoured carrier is a protein known as CRM197.

Claim 1 of the 363 patent is as follows:

A multivalent immunogenic composition, comprising 13 distinct polysaccharide-protein conjugates, together with a physiologically acceptable vehicle, wherein each of the conjugates comprises a capsular polysaccharide from a different serotype of Streptococcus pneumonia conjugated to a carrier protein, and the capsular polysaccharides are prepared from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F, wherein the carrier protein is CRM197

As you can see, the claim itself specifically lists 13 serotypes. Wyeth nonetheless argued that the claim extended to vaccines with more serotypes, on the basis that the word “comprising” means “included but not limited to” [54]. Substantively, Wyeth argued that it had invented a “platform” which could be used to add other serotypes [52].

As I understand it, Merck accepted this interpretation of the word “comprising” but argued that the claim was nonetheless limited to 13 serotypes by the “wherein” clauses [55]. Gagné ACJ accepted Merck’s construction, but without directly accepting the argument as to the limiting effect of the “wherein” clauses.

Gagné ACJ rejected Wyeth’s argument for a number of reasons. First, “In Purdue Pharma v Canada (Attorney General), 2011 FCA 132 at para 22 [Purdue Pharma] the Federal Court of Appeal held that even if the word “comprising” used in claim language could be regarded as open-ended, the inclusion of other elements requires some justification. The basis for such an inclusion must be found within the confines of the patent. No such basis existed in Purdue Pharma, and none can be found in the 363 Patent” [22]. I didn’t like that aspect of the Purdue Pharma when I blogged on it, and I still don’t like it in that context, in part because claim construction is more certain if we accept that “comprising” has a definite meaning. Moreover, “comprising” is and should be used to encompass the addition of elements that have no effect on the invention. It is therefore problematic to require that “There must be a basis for it within the confines of the patent” [Purdue Pharma 22], because elements that have no effect on the invention are unlikely to be mentioned or contemplated.

With that said, I find the point much more persuasive as Gagné ACJ used it in the context of this claim. It is really a stretch to argue that “comprising” encompasses additional serotypes, even though that is grammatically consistent with its normal meaning of “included but not limited to.” As just noted, “comprising” is normally used to encompass ancillary components, or at least unforeseen improvements. In this case, 90 other serotypes were known at the time, and 50 had a known structure [53], [60] and presumably these were in the contemplation of the drafter at the time. If the drafter had intended to claim a “platform” encompassing some of these other serotypes, that would have been very easy to do, for example by saying that the capsular polysaccharides are prepared from serotypes “including” the 13 listed.

Gagné ACJ also relied on the fact that the disclosure was specific about the 13 serotypes that were included: “There is no mention in the 363 Patent of a need, a desire, or a basis for adding any other serotype,” even though “some 90 serotypes were known at the time” [60]. Now, strictly these observations might be considered to be reading limitations from the specification into the claims, but if Wyeth had really intended to claim a platform, presumably it would have made some kind of explicit reference to the additional serotypes, even if only in broad language to the effect of “the compositions of the invention may also include other known serotypes.” So, the specification expressly stated that “The compositions of this invention may further include one or more additional antigens for use against otitis media caused by infection with other bacteria,” and went on to specify other suitable antigens by name (p16). If the drafters contemplated completely different antigens, they must have been contemplating other S pneumoniae serotypes. But there is no hint of that, apart from the consistent use of the word “comprising” in the disclosure. This again goes to the point that if the drafter had really intended to claim a platform, they would have thought of this, and it would have been very easy to do.

As noted, Gagné ACJ didn’t appear to rely on Merck’s argument that the “wherein” clauses have a limiting effect. I am inclined to agree. The real question is whether the list of 13 serotypes should be considered exhaustive, and I don’t really see how “wherein” addresses that, one way or the other. That is, if the claim stated that the capsular polysaccharides are prepared from serotypes “including” the 13 listed, we wouldn’t have any problem construing it as encompassing other serotypes, “wherein” notwithstanding.

So, while I don’t see any easy knockdown argument, I largely agree with Gagné ACJ’s analysis. My only real quibble is that Gagné ACJ also noted that if Wyeth’s construction were accepted “It would also mean that the ambit of Wyeth’s monopoly could grow over the life of the 363 Patent as new serotypes – or their structure – are discovered. This would be contrary to the fundamental principles of claims construction (Free World at para 57)” [66]. With respect to the SCC, this is not a fundamental principle of claims construction. I addressed this in my article “What does Actavis v Lilly Mean for Canadian Law? (Part II) (2019) 31 Intellectual Property Journal 267 at 289. I excerpt part here, without footnotes:

The difficulty with this logic is that it is exceedingly well established that a claim may indeed encompass after-arising technology, even if that new technology is a patentable improvement. As Bowen LJ remarked more than a century ago, in Wenham Gas Co Ltd v Champion Gas Lamp Co, “The superadding of ingenuity to a robbery does not make the operation justifiable.” This rule has since been applied in many cases, including the Supreme Court’s own decision in Grip Printing, in which the Court held that there was infringement, notwithstanding that the variants might have been improvements, in the face of the respondent’s argument that there is no infringement if the defendant uses an article that “was not known as an equivalent at the date of the patent.” The same rule was also recognized by Lord Hoffmann in Kirin-Amgen, who remarked that “[t]here is no difficulty in principle about construing general terms to include embodiments which were unknown at the time the document was written.” To my knowledge, the rule that after-arising technology may infringe has never been doubted.

The rationale is simply that it is an infringement to take the essential elements of the patented invention, and it does not matter whether other elements are added or subtracted. This is evidently true when the variants are trivial, but it is equally true when the variant is inferior, and it remains true if the variant happens to work better than the original, whether the improvement is minor, or so substantial as to merit its own patent.

Of course, that is a criticism of the SCC, not of Gagné ACJ, who is entitled to rely on SCC precedent, but nonetheless, that precedent is shaky.

Claim Construction and Inducement Potpourri

Guest Tek Interactive Entertainment Ltd v Nomadix Inc 2021 FC 276 McHaffie J

2,600,760 / 2,750,345

In Guest Tek v Nomadix McHaffie J held Guest Tek’s 760 and 345 patents to be valid but not infringed [284], [437], in a very careful—and long–decision that turned almost entirely on claim construction and the facts. One thing that jumped out is a stylistic innovation, namely the use of italics to indicate claim elements: for example “In my view, the POSITA would understand the notion of user load to be a function of the number of current users and/or their demand” [340]. I love it. For whatever reason, the use of italics rather than more traditional quotation makes the sentences flow more naturally while still retaining all the same information. It also means that quotation marks are reserved for quotations from the evidence, which eliminates ambiguity when a paragraph quotes the experts about the meaning of specific claim terms.

Turning to the substance, Guest Tek and Nomadix each provide network gateway equipment and supporting software to hotels, which allows multiple hotel guests to access the internet through the gateway provided by the hotel [14]. The patented technology relates to network security and bandwidth management. I must say that after reading pharma cases for years, I found the technology at issue in this case a bit difficult to follow. McHaffie J’s decision generally simply applied established law, apart from the points discussed in Friday’s post, but a few points of some interest were raised in respect of claim construction and inducing infringement. The validity attacks on both patents do not appear to have been pursued very vigorously. It seems that Nomadix’s stronger arguments were addressed to the scenario where Guest Tek had prevailed on claim construction and infringement.

Claim Construction

Friday’s post discussed McHaffie J’s conclusion that recourse to the disclosure is always permissible in claim construction, not just when the claim term is ambiguous when read in isolation. However, this holding did not ultimately affect the analysis: there were two cases where reference to the disclosure was necessary to resolve an ambiguity, and reference to the disclosure otherwise simply confirmed the construction arrived at from the claims alone [48].

McHaffie J’s analysis otherwise applied established principles to the facts, but there are a few points of passing interest.

Claim element redundancy

McHaffie J noted that the principle against redundancy is typically applied as between claims (ie, to avoid claim redundancy) “but in my view it has some value in assessing redundancy of elements within a claim” [150]. I don’t think I’ve seen that point made before; it makes sense to me. On the facts, he nonetheless ultimately preferred a reasoning that resulted in claim element redundancy [150]; this is consistent with the general point that the principle against redundancy is an aid to construction and not a strict rule of law.

“First” and “second” distinguish rather than sequence

Nomadix had argued that the reference to “first packets” and “second packets” were used to indicate the sequence of in which the packets were sent. McHaffie J rejected this, holding that the cases “confirm that the terms ‘first’ and ‘second’ are used in the practice of patent drafting as a means of distinguishing elements rather than necessarily sequencing them” [100]. This is not very surprising (and of course there may be patents where the terms are used to indicate sequence), but McHaffie J’s discussion is a good citation on this point if one is needed.

Constructions making infringement impossible are to be avoided

McHaffie J held that a claim should not normally be construed so that no real-world product could possibly infringe [133], [135].

Balance between text and purpose

McHaffie J noted that claim construction requires “a balance between two evocative terms well known in patent law: the Court should construe a patent with ‘judicial anxiety’ to support a useful invention, but if the inventor has created troublesome limitations in the claims, this is a ‘self-inflicted wound’ the Court will not cure” [50]. The decision provided an nice illustration of this balance; at one point McHaffie J adopted a purposive construction, looking to a function of the device to clarify the meaning of an ambiguous term [188], but at the same time, when another element was clear on the text, he hewed to it, even though that might have resulted in a self-inflicted wound [166]– [167].

Inducement

Guest Tek argued that Nomdix induced infringement of the 760 by hotels in Canada, and did not plead direct infringement [202]. The established law of inducement has a three-prong test Corlac 2011 FCA 228 [162], quoted at [56]:

First, the act of infringement must have been completed by the direct infringer. Second, the completion of the acts of infringement must be influenced by the acts of the alleged inducer to the point that, without the influence, direct infringement would not take place. Third, the influence must knowingly be exercised by the inducer, that is, the inducer knows that this influence will result in the completion of the act of infringement.

Ultimately, the inducement argument failed on the first step, as Guest Tek did not establish direct infringement by any Canadian hotel using a Nomadix gateway [255]. Guest Tek argued that direct infringement occurred when a Nomadix gateway is connected to a wireless access point in a network operated by a hotel, but Guest Tek did not call any witnesses from Canadian hotels, or from Nomadix resellers in Canada, to speak to network configuration in Canadian hotels. Instead, Guest Tek relied primarily on the functionality of the Nomadix gateway itself [204]. Ultimately, as I understand it, Guest Tek at most established that it was possible to configure a Nomadix device so that it would infringe, but there was no evidence that it had actually been configured to infringe in any hotel in Canada: see eg [227], [229]. (There are however, a couple of paragraphs that might suggest that the Nomadix gateway could not be configured to infringe: see eg [232], [234]. I’m sure the point would be clear if I understood the technology a bit better.) In any event, whether or not it could be configured to infringe, non-infringing configurations are certainly possible and apparently quite normal. This conclusion followed in part from claim construction; presumably Guest Tek would have had a stronger argument on direct infringement based on functionality alone if it had prevailed on some of the key claim construction issues. (Though I have to admit I didn’t go back to reverse engineer the arguments to be sure.)

Test for causation at the second branch

McHaffie J accepted that the second branch requires a “but for” test for inducement [58]. While that is certainly the standard articulation of the test, in a draft article, “Is 'But For' Causation Necessary to Establish Inducement?” available on SSRN, I have argued that a material contribution test for causation should be used at the second stage, though “but for” causation is still required to establish damages. Given McHaffie J’s holding on direct infringement, this point did not arise. Moreover, McHaffie J held that Guest Tek “has not established that Nomadix influenced Canadian hotels to configure their wireless access nodes in this way or any particular way” [245], [247], [248]. Consequently, inducement would not be established even on the material contribution test that I proposed in my article; that test comes into play, for example, where the defendant had clearly instructed the direct infringer to use the product so as to infringe, but it is not clear whether the direct infringer paid any attention to those instructions. That is, my argument is that inducement sufficient to support injunctive relief should be established if the indirect party sold a product along with instructions to infringe, and the direct infringer did in fact infringe, whether or not the direct infringer read the instructions. The effect would be that an indirect party could sell a product that could be used to infringe, but would not be allowed to provide instructions to infringe. Damages would still require “but for” causation, not as a matter of the test for inducement, but as a matter of the test for damages.

Contributory infringement

McHaffie J was also kind enough to refer to my article Contributory Infringement in Canadian Law (2020) 35 CIPR 10 (draft version here). In that article, I noted that Canadian courts have consistently expressly said that there is no liability for contributory infringement—see eg MacLennan v Produits Gilbert 2008 FCA 35 [33], but I argued that nonetheless, the reasoning and results in almost all the leading cases support a rule that supply of a product especially adapted to infringe, and with no substantial non-infringing use, constitutes indirect infringement, even in the absence of active inducement. (The exception is Slater Steel (1968), 55 CPR 61 (Ex Ct), which I argued was wrongly decided). McHaffie J remarked while my article was interesting, he agreed with Nomadix “that the FCA has confirmed ‘contributory infringement’ is not recognized as a cause of action in Canadian law,” citing Nycomed 2012 FCA 195 [3]. Now that’s certainly true in terms of express statements of the law; my argument is that it would be open to the FCA to recognize contributory infringement in light of the reasoning and results in the leading cases; but given the express statements of the law, such as that in Nycomed, it would probably be up to the FCA to recognize the point.

In any event, the issue didn’t arise in this case. The issue of contributory infringement arises when the product sold is not in itself patented, but is especially adapted to infringe; the question is whether indirect infringement can be established by mere sale of a product that “cannot be used for any other purpose,” as the FCA put it in MacLennan, even in the absence of a separate act of inducement. As noted above, in this case the inducement allegation failed because Guest Tek did not even establish direct infringement: “As the evidence does not establish Nomadix influenced Canadian hotels with respect to these issues, it equally does not establish any direct infringement would not have occurred but for that influence” [250]. The Nomadix gateway was clearly not a product especially adapted to infringe, or that could not be used for any other purpose; non-infringing configurations were possible and normal. Therefore the issue of contributory infringement does not arise, and it would have made no difference to the outcome or the reasoning if McHaffie J had accepted my argument.