Monday, October 3, 2022

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.

Monday, September 19, 2022

Common General Knowledge and a Reasonably Diligent Search

Gemak Trust v Jempak Corporation 2022 FCA 141 Mactavish JA: Gleason, Roussel JJA revg Gemak v Jempak 2020 FC 644 Lafrenière J

            2,276,428 / 2,337,069

In the decision under appeal Lafrenière J granted summary judgment dismissing Gemak’s action for patent infringement against Jempak. My last post dealt with the FCA’s holding that Lafrenière J erred in deciding the matter on a motion for summary judgment. While that was sufficient to dispose of the appeal, the FCA went on to hold that Lafrenière J also made two further errors, namely an error of law in assessing the common general knowledge, which Mactavish JA chose to address in order to provide guidance in future cases [92], as well as error in assessing testing evidence.

Common General Knowledge

On the first point, in a passage quoted by Mactavish JA [94], with emphasis added, Lafrenière J stated that in assessing the common general knowledge:

[FC 97] The Court must assess what knowledge the skilled person would have obtained through a diligent search conducted using the means available at the relevant time.

Focusing on the emphasized phrase, Mactavish JA pointed out that there is a well-established distinction between the prior art—any matter available to the public, no matter how obscure [97]—and the common general knowledge, which is more limited than the entire prior art, and indeed does not even encompass all information available to the skilled person.*

Mactavish JA then held that it was an error to apply the concept of a reasonably diligent search to the common general knowledge:

[99] The requirement of the reasonably diligent search has been applied - not with respect to the identification of the common general knowledge of the POSITA - but rather with respect to the discoverability of prior art relevant for the purpose of the obviousness or anticipation analyses: see, for example, E. Mishan & Sons, Inc. v. Supertek Canada Inc., 2015 FCA 163 at para. 22.

As a preliminary point, Mishan v Supertek was an obviousness case, and, so far as I know, the the requirement of the reasonably diligent search has never been applied in the context of anticipation; it has long been accepted that all prior art is relevant to novelty (subject to historical restrictions restricting foreign prior art to printed matter, presumably for evidentiary reasons, which were removed by the new Act in 1993). The concept of a reasonably diligent search had been applied in the context of obviousness, though, as Mactavish JA went on to note, that was changed by Hospira 2020 FCA 30, so that all prior art is now potentially potentially relevant for the purpose of the obviousness analysis [99]–[100]. (To be clear, that is not to say that all prior art is part of the CGK even in the obviousness context.)

Mactavish JA continued:

[100] That said, knowledge that is only discoverable through a reasonably diligent search is not, and has never been, considered to be part of the common general knowledge. The Federal Court thus erred in finding otherwise.

This is a negative definition—it says that information that is only discoverable through a reasonably diligent search is not considered to be “generally known” and so cannot form part of the CGK. This raises the question of whether the CGK excludes information requiring any kind of search. Lafrenière J [FC 97] had begun that paragraph by defining the common general knowledge as being “the knowledge generally known by the skilled person at the relevant time, and includes what the skilled person may reasonably be expected to know and be able to find out.” Mactavish JA [93] quoted this passage as being a correct statement of the law, “at least to the extent that the common general knowledge includes what the skilled person may reasonably be expected to know,” thus casting doubt on the phrase “and be able to find out.” However, in Novopharm v Janssen-Ortho / levofloxacin 2007 FCA 217 [25.3] the FCA defined the CGK as including “what the person may reasonably be expected to know and to be able to find out” (my emphasis). That was recently endorsed by the FCA in Tetra Tech v Georgetown Rail Eqpt 2019 FCA 203 [28]. Mactavish JA cannot have intended to cast doubt on these cases, which were not mentioned.

Further, allowance for at least some degree of search seems necessary. As Laddie J noted in Raychem Corp’s Patents [1998] RPC 31 (Pat) 40:

for something to qualify as common general knowledge it is not necessary to show that all or a majority of the workers in the field knew it, in the sense of having memorised it. For example in the days before the ready availability of pocket calculators, most technicians needed to use log tables for mathematical calculations. Few if any of them could memorise any of the log conversions in such a table yet those conversions would be common general knowledge in the patent sense.

Thus the view that information that can only be found through some sort of search, albeit perhaps very limited, is thus well supported by authority and logic.

This does not imply that the CGK extends to knowledge discoverable only through a reasonably diligent search. Looking up logarithms is routine. Perhaps the CGK includes information that the skilled person would reasonably “be able to find out,” but does not include information that is only discoverable through “a reasonably diligent search.” This distinction would reconcile Mactavish JA’s holding that knowledge that is only discoverable through a reasonably diligent search is not part of the CGK with the FCA decisions in Levofloxacin and Tetra Tech. I have not seen this distinction explicitly made before in Canadian law, but it does have antecedents in UK law.

In Raychem, Laddie J noted that in General Tire [1972] RPC 457 (CA), which remains the leading case on CGK, in Canada as much as in the UK, the Court at 482 described the CGK as being derived from “a common-sense approach to the practical question of what would in fact be known to an appropriately skilled addressee.” Laddie J continued (my emphasis):

The court is trying to determine in a common sense way how the average skilled but non-inventive technician would have reacted to the pleaded prior art if it had been put before him in his work place or laboratory. The common general knowledge is the technical background of the notional man in the art against which the prior art must be considered. This is not limited to material he has memorised and has at the front of his mind. In includes all that material in the field he is working in which he knows exists, which he would refer to as a matter of course if he cannot remember it and which he understands is generally regarded as sufficiently reliable to use as a foundation for further work or to help understand the pleaded prior art.

The notion that the technical background of the skilled person is not restricted to what they would have memorized has been extended to what is sometimes called the secondary common general knowledge. (That phrase seems to have been coined by Arnold J, as counsel in Actavis v Novartis [2009] EWHC 41 (Ch) [128]; while it does not seem to have caught on, even in the UK, it is a convenient term.) As Pumfrey J explained in Novartis v Ivax [2006] EWHC 2506 (Pat) [25]:

It is well settled that the common general knowledge is knowledge that must be attributed to the skilled person, without which the latter may be taken not to be skilled. To it must be added any knowledge that every skilled person should be taken to acquire before he embarks on the problem to which the patent provides the solution, as, for example, the relevant properties of cyclosporin if the problem is to formulate cyclosporin.

As this passage indicates, knowledge that a skilled person would acquire only when faced with a particular problem is not strictly part of the CGK. In KCI Licensing [2010] EWHC 1487 (Pat) [108], Arnold J has described it as “information that, while it was not part of the skilled addressee's common general knowledge, would have been acquired by him as a matter of routine before embarking on the problem to which the patented invention provides the solution.”

So, some information which the skilled person would not have memorized, but would always have readily to hand, is part of the CGK (logarithms), while other such information which the skilled person would acquire as a matter of routine, but only when faced with a specific problem (the properties of cyclosporin), is not part of the CGK. (Always with the proviso that the information must be regarded as a good basis for further action.) Jacob LJ made this distinction in Generics v Daiichi [2009] EWCA Civ 646 [25]:

Of course material readily and widely to hand can be and may be part of the common general knowledge of the skilled person – stuff he is taken to know in his head and which he will bring to bear on reading or learning of a particular piece of prior art. But there will be other material readily to hand which he will not carry in his head but which he will know he can find if he needs to do so (my emphasis).

This distinction may be important in some cases, as Jacob LJ went on to explain at [25]–[28]: in addressing the problem solved by the invention, the skilled person may acquire certain information through routine inquiry, and that information can then be brought to bear on that particular problem. But, unlike the common general knowledge, the skilled person would not have that information at hand in addressing an entirely different problem. If A would be discovered by routine inquiry in addressing problem X, and B would be discovered by routine inquiry in addressing problem Y, this does not mean that it would be obvious to combine A and B to solve problem Z, even though it might be obvious to combine A and B to solve problem Z if both A and B were part of the CGK, strictly defined.

In effect, UK law draws a distinction between two types of information that the skilled person would not have memorized, but which they would find as a matter of routine: there is information which they know is of general usefulness, and which they would apply to any problem, and information which they would only seek out in when faced with a specific problem. The former is part of the CGK, and the latter is not. To draw an analogy, a mechanic might have a toolbox he carries with him to work sites, corresponding to information the skilled person has memorized; then there are tools, such as a hex wrench in a non-standard size, that he does not have in his toolbox, but that he keeps back at the shop, and he knows it is available if necessary, corresponding to logarithm tables. These are both part of the CGK. Then there are special tools to remove a custom fastener on a particular brand of machine. When the mechanic comes across such a fastener, he will know he can readily get it from the manufacturer, and he will know how to use it to fix the machine, without the exercise of any ingenuity on either front; this corresponds to the secondary CGK. But he will not think to combine the special tool for one machine with the special fastener from another machine, to solve a problem he faces on a third kind of machine.

So, at least in English law, there is a distinction between information which the skilled person knows is available as a matter of routine, and information which the skilled person can find without undue burden when faced with a specific problem. The former is part of the CGK and the latter is not.

This may be the kind of distinction Mactavish JA had in mind, though I’m not entirely sure. After all, she seemed to cast doubt on the idea that the CGK includes information that the skilled person would be able to find out, but it is clear that information may be part of the CGK even if the skilled person would not have it memorized. And it is by no means clear that the distinction necessary to reconcile Mactavish JA’s decision in this case with Levofloxacin and Tetra Tech—which is to say the distinction between information the skilled person would be able to find out and the information discoverable in a reasonably diligent search—corresponds to the distinction drawn in UK law. On the other hand, if we consider that the information discoverable in a reasonably diligent search corresponds to the secondary common general knowledge, as that term is used in English law, then it is indeed true that such information is not and never has been part of the CGK.

I must say that it strikes me as somewhat harsh for Mactavish JA to have criticized Lafrenière J on this point. The distinction is “subtle,” at least in the opinion of Kitchin J (now of the UKSC), at first instance in Generics v Daiichi [2008] EWHC 2413 (Pat) [40]. Moreover, the error, such as it was, made no difference in this case. There was no dispute as to the common general knowledge [FC 4], [FC 101], so there is no particular piece of information that was include by Lafrenière J that would be excluded by Mactavish JA’s approach.

Further, it is worth pointing out even if information that is only discoverable in reasonably diligent search is not part of the CGK, that does not imply that it cannot be applied outside the context of obviousness. For example, it is very well established that patent is enabling even if the skilled person cannot practice the invention without carrying out some experiments, so long as those do not require undue effort: see BRP v Arctic Cat 2018 FCA 172 [78]. Presumably the skilled person can also be expected to carry out a routine literature search. When the patent claims a compound that can be made using conventional methods, it is common for the specification to say as much, typically referring to a leading handbook or a journal article for the details of the method. Such a specification is undoubtedly sufficient, even if the ordinary skilled person might have to actually consult the work referred to in order to carry out the synthesis. Suppose the specification stated that the compound could be prepared by conventional methods, but failed to actually cite the leading textbook. The specification would no doubt still be sufficient if the details of the method could be found in the standard textbook that the skilled person would consult as a matter of routine. The parallel with secondary CGK in the obviousness context is exact, as the skilled person attempting to practice the invention in light of the specification is faced with a specific problem, and so can be expected to carry out routine research to address that problem.

So far as I can tell, the distinction between information that a skilled person knows of and would be able to find out as a matter of routine, and information that the skilled person would find out after a search in light of a particular problem, only matters in the context of obviousness, and the problem of combining obscure prior art. The point made by Jacob LJ, that secondary CGK is not CGK strictly speaking, means that two pieces of prior art that are both only secondary CGK cannot be combined to make the invention obvious. This point would be better addressed explicitly, as part of that ongoing discussion, rather than with an abstract definition of the CGK.

*As an aside, Mactavish JA stated that a piece of knowledge only becomes general knowledge “when it is generally known” and “accepted without question” by those skilled in the art [96], quoting from Cefaclor liability 2009 FC 991 [97], which quoted from General Tire [1972] RPC 457 (CA) 482–83, which in turn quoted from British Acoustic Films Ltd v Nettlefold Productions (1936) 53 RPC 221 (Ch) 250. However, as the English Court of Appeal noted in General Tire, 483, in a passage also quoted in Cefaclor liability 2009 FC 991 [97], “accepted without question” may be “putting the position rather high”; the Court of Appeal indicated that “generally regarded as a good basis for further action” is preferable. The “good basis for further action” formulation is now generally accepted: see also Mylan v Eli Lilly / tadalafil 2016 FCA 119 [24]. Nothing turned on the point and I am sure that Mactavish JA did not intend to hold that “accepted without question” is the correct standard, as her focus was on the distinction between the prior art and the common general knowledge; that is, the decision focuses on what it means for information to be eligible to be part of the CGK because it is “generally known”, while recognizing that not all information that is generally known is part of the CGK.

Testing Evidence

Turning to the testing evidence, a key issue was whether Jempak’s detergent pods had detectable levels of carboxymethyl cellulose [CMC] in the coating, which was an essential element of the claims. Jempak’s expert gave evidence that there was no detectable CMC, and this evidence was criticized by Gemak’s expert on the basis that the testing method used by Jempak’s expert was not sufficiently sensitive. Lafrenière J rejected this, partly on the basis that Gemak’s expert did not have experience with the kind of detergent formulations at issue, and consequently he “did not provide an opinion from the perspective of the skilled person of the Patents” [FC 129], [107]. But Mactavish JA pointed out that Gemak’s expert was not construing the claims, but rather was providing expert evidence with respect to the question of infringement. Infringement is a question of fact. In this case, the question was whether or not the coating in fact contained CMC, not whether a person skilled in the art would have been able to detect the CMC as of the date of publication. Consequently, there is no requirement that the testing method used by the expert witness is one that would have been used by the skilled person:“Reviewing courts have . . . endorsed the use of analytical chemistry techniques that would not have been available to a POSITA at the relevant time or that would have been beyond the abilities of a POSITA” [108].

Tuesday, September 13, 2022

Putting the Brakes on Summary Disposition?

Gemak Trust v Jempak Corporation 2022 FCA 141 Mactavish JA: Gleason, Roussel JJA revg Gemak v Jempak 2020 FC 644 Lafrenière J

            2,276,428 / 2,337,069

The past couple of years have seen a significant shift in practice related to summary judgment and summary trial. The old practice, as I understand it, is that summary judgment was almost never granted, on the view that patent trials normally turn on the expert evidence and the credibility of expert witnesses can only properly be assessed in a viva voce trial. As Manson J put it in Canmar v TA Foods 2019 FC 1233 [45]–[46], for a decade after the FCA restricted the availability of summary judgment in MacNeil Estate 2004 FCA 50, “summary judgment as a just, efficient and expeditious means to resolve disputes on a proportionate basis was lost” [45], until Hryniak v Mauldin 2014 SCC 7 resulted in “a culture shift” that “opened the door for a more reasoned approach to the use of summary judgment motions” [46]. I believe Canmar, affd 2021 FCA 7, was the first in the new wave, but since then we have seen an upsurge in decisions granting summary disposition. The FCA decision in Gemak v Jempak suggests that the brakes might need to be applied.

In the decision under appeal Lafrenière J granted summary judgment dismissing Gemak’s action for patent infringement against Jempak. Lafrenière J acknowledged that the court has been reluctant to grant summary judgment in patent cases, because they often turn on the credibility of expert witnesses [77], [FC 4], but he nonetheless held that summary judgment was appropriate in this case because “there is no substantial conflict of opinion evidence. Jempak’s expert is the only witness who provides an informed and purposive claim construction of the terms at issue from the perspective of a skilled person” [FC 4], [78]. Lafrenière J entirely dismissed the evidence of Gemak’s expert, Dr Frankenbach [FC 110], [81]–[82], on the basis that she gave “evasive and defiant responses”, “conducted herself like an advocate instead of a neutral objective expert” and generally “failed to provide fair, objective and non-partisan opinions” [FC 104], [FC 110], [80]–[81]. However, Mactavish JA pointed out that much of the difficulty in Dr Frankenbach’s testimony was due to the combative stance taken by counsel for Gemak, and the conduct of counsel should not reflect negatively on the credibility of the witness [84]–[85].

Further, Lafrenière J remarked on “evasive and defiant responses from Dr. Frankenbach” and found the evidence of Dr. Frankenbach to be “wanting and problematic in many respects.” But Mactavish JA stated that

[86] a review of the transcript of her cross-examination suggests other possible interpretations of her evidence. Rather than being ‘evasive and defiant’, the transcript could be read to suggest that Dr. Frankenbach was a careful witness, one who wanted to be sure that she understood questions before answering them, and one who would not allow herself to be pushed around by counsel.

Importantly, she went on to state that “it is very difficult to infer a hostile attitude on the part of a witness from a bare review of a transcript, in the absence of an ability to evaluate his or her viva voce testimony” [87].

The FCA consequently held that it was “a palpable and overriding error on the part of the Federal Court to make the negative credibility findings that it did with respect to the evidence of Dr. Frankenbach based on a transcript of her testimony, and to decide the case in reliance on those findings” [90]. The FCA directed that the matter proceed to trial [112].

The interesting question arising from this decision is whether it is a signal from the FCA that the recent enthusiasm for summary disposition needs to be tempered, or whether the decision simply turned on the facts of the particular case.

In support of the view that it turned on the facts of the case, the key point in the FCA holding was that Lafrenière J’s decision explicitly turned on a negative credibility findings, and it was an error to make such a finding based on a transcript. On the other hand, the FCA took the opportunity to review the principles governing summary judgment at some length [61]–[74], even though there was no dispute between the parties as to those principles [61]. Many of Mactavish JA’s statements were phrased in general terms, and she emphasized the importance of viva voce evidence: “The jurisprudence is clear that issues of credibility ought not to be decided on motions for summary judgment” [68]; “the difficulty in assessing the credibility of expert witnesses in complex patent cases on the basis of voluminous paper records was long recognized” as a defect in the old PM(NOC) procedure [69]; and “ the lack of viva voce testimony provided for in the NOC Regulations was one of the inadequacies in the old regime” that led to it being modified to provide for a full trial [70]. These are exactly the reasons why summary judgment was traditionally avoided. Further, Mactavish JA summarized by saying that “[c]ases should therefore go to trial where there are serious issues with respect to the credibility of witnesses” [71]. This was phrased as a general propostion. Moreover, in support she cited, inter alia, MacNeil Estate 2004 FCA 50—the decision which, in Manson J’s account, put the brakes on summary trial in the first place. She also relied on Suntec v Trojan Tech 2004 FCA 140, which also predates Hryniak. Mactavish JA made the general observation that “while patent infringement issues are not by definition excluded from the ambit of the summary judgment process, they tend to raise complex issues of fact and law that are usually better left for trial” [91]. While she did go on to say that “this is not a hard and fast rule” and “there will be cases where use of the summary judgment process is appropriate,” this is a clear statement of a general principle, not a point that was confined to the facts of this case.

While the FCA discussion focused entirely on summary judgment, it seems to me that many of the observations, such as those related to the need for viva voce evidence, apply with equal force to summary trial; the FCA’s central holding was that it was “a palpable and overriding error on the part of the Federal Court to make the negative credibility findings that it did with respect to the evidence of Dr. Frankenbach based on a transcript of her testimony, and to decide the case in reliance on those findings” [90].

Time will tell, but for now my sense is that the FCA is sending a message that the Federal Court should be more cautious in granting summary disposition, at least when the credibility of witnesses is involved—but that will often be the case.

The problem is a difficult one. On the one hand, it would be desirable to reduce the cost of patent litigation, particularly in contexts where the expense of patent litigation is exploited to extract unjustifiable settlements. On the other hand, assessing patent validity and infringement on a reduced record may be unfair. Encouraging access to justice is certainly desirable, but the ‘justice’ aspect is as important as the ‘access’ part. Flipping a coin would be much cheaper than trial as a means of settling patent disputes, but no one thinks it is better for that reason. How to strike the balance is a very difficult question, as the cost and complexity of patent litigation cuts both ways.

With all that said, I will end with a very tentative proposal. Before American Cyanamid [1975] UKHL 1, a motion for an interlocutory injunction required a showing of a prima facie case on the merits. My understanding is that parties would use this to get what amounted to a non-binding opinion on the merits, on an abbreviated record, from the judge who would ultimately be hearing the case. The parties would often then settle in light of that opinion, but a party who thought they could do better on a full record was fully entitled to go to trial. (Over time the abbreviated record got longer and longer—the hearing in Cyanamid was three days at first instance and eight days in the Court of Appeal. One solution to that problem is better case management, rather than doing away with consideration of the merits, and it seems that most jurisdictions are now going that way.)

I wonder if it might be possible to adapt the motion for summary disposition to a similar effect. (I expect this would require an amendment to the Federal Courts Rules.) In particular, if the judge hearing the motion for summary disposition is of the view that one side had a prima facie weak case, but the matter was not suitable for summary disposition because, eg it was necessary to assess credibility viva voce, the judge might dismiss the motion, but at the same time issue what would amount to a non-binding direction on costs, to the effect that if the case turned out to be as weak as it appeared to be, costs would be assessed against the party with the weak case at a substantially elevated scale — say 75% rather than 25%. It would be non-binding, in the sense that the elevated costs award would not be automatic if the party against whom it was issued lost at trial. Rather, the trial judge would take it into account and award elevated costs if the party against whom it was issued had not improved their case at trial. If the party lost, but the judge was of the view that the full trial really had improved the court’s ability to assess the evidence, it would be open to the judge to ignore their prior directive and award costs on the normal scale. The party with the weak case would thereby be put on notice that there would be significant costs consequences if it proceeded to trial, unless it was confident that a trial really was necessary to present it’s position fairly. As with the old interlocutory injunction practice, this would provide an incentive to settle, based on a non-binding opinion on the merits from the judge who would ultimately hear the case. The difference is that in the interlocutory injunction case, the question was whether the plaintiff had a strong case, and in this suggestion, the question is whether one of the parties has a weak cases; but the basic concept of a preliminary assessment of the merits on reduced record is the same. Of course, a judge hearing a summary disposition motion would not be required to issue any such directive in dismissing the motion; it would remain open to the court to simply hold that the matter was not suitable for summary disposition.

I’m not a litigator, so I don’t have a good sense of whether this would work in practice. Indeed, I hesitated to post the suggestion at all. But I decided I might has well make the suggestion for consideration.

Thursday, September 8, 2022

Date for Assessing Sufficiency Redux

Pharmascience Inc v Bristol-Myers Squibb Canada Co 2022 FCA 142 Locke JA: de Montigny, Monaghan JJA affg 2021 FC 1 Zinn J FC Selection

2,461,202 / 2,791,171 / apixaban / ELIQUIS

In Teva / sildenafil 2010 FCA 242 [79] and Idenix v Gilead 2017 FCA 161 [46], the FCA held that the correct date for assessing sufficiency is the filing date, not the date of issue. In my post “What Is the Date for Assessing Sufficiency?” I indicated that Locke JA in Pharmascience v Bristol-Myers Squibb 2022 FCA 142 may have reopened the question, with a decision that might be taken to suggest that the date of issue was appropriate. Steve Hundal, has a recent blog post arguing that on the contrary, Locke JA was simply saying that it is the specification as issued that is relevant in assessing sufficiency, without disturbing the prior FCA holding that sufficiency is assessed in light of the common general knowledge as of the filing date. This is in the same way that novelty is assessed as of the claim date, but on the basis of the claims as issued. On reflection, I’m sure that is indeed the best way to read Locke JA’s decision.

In my defence, I will say that Locke JA indicated that the question was “the date for determining sufficiency” [26] “the relevant date for determining patent sufficiency” [28], and he spent several paragraphs discussing Zoledronate 2013 FC 283 [179]–[188] which clearly concerned the date for assessing sufficiency. (He also adverted to Merck v Apotex 59 CPR(3d) 133 (FCTD) [115]–[120], which also, on it’s facce, concerns the date for assessing sufficiency, though both the argument and the analysis in Merck v Apotex were a bit peculiar.)

But Mr Hundal is right to point out that there are other passages that indicate that Locke JA’s was simply saying that sufficiency is assessed in light of the specification as issued, not at some earlier date: see [32], [33]; and [31], which draws the parallel with assessing claims as issued for novelty and obviousness as of the claim date, and for utility as of the filing date. Further, I now see that the distinction between the date for assessing sufficiency, and the document to be assessed—the specification as filed or at some later date—is made very clearly by Zinn J at first instance: see eg [FC 37], [FC 43]. And this way of reading Locke JA’s decision has the great virtue that it is entirely consistent with the holding in Teva / sildenafil or Idenix v Gilead that sufficiency is assessed as of the filing date; it also explains why Locke JA did not mention those cases.

So, I think we can consider it still settled that the filing date is the correct date for assessing sufficiency, though it is the specification as issued that must be sufficient, not the specification as it was at some earlier date.

Now, there is still a problem. Some of Locke JA’s remarks could be taken to suggest that amendments to the specification might make a specification sufficient even thought it was insufficient as filed: eg “subsection 27(6) and section 38.2 of the Patent Act, while limiting the matter that can be added to a patent application by way of amendment, do permit amendments, and without restriction as to whether such amendments might buttress the sufficiency of the specification” [36, my emphasis]; and “it would effectively read out subsection 27(6), which contemplates amendments to bring the application into compliance with the sufficiency requirements” [33]. This raises some difficulties. In Idenix, the specification at filing did not enable a skilled person to synthesize the claimed compound, and indeed, the applicant did not know how to do so. The information on how to make the compound was subsequently made public, prior to issuance. It would be problematic if the applicant could have incorporated that into the specification, thereby rendering it sufficient: as Lord Hoffmann noted in Biogen v Medeva [1996] UKHL 18 [81],“[i]t would be illogical if a patent which ought to have been rejected [on examination by the Patent Office] is rendered immune from revocation [by the court] by advances in the art between the date of application and the publication of the specification.”

I think the answer to the problem is that, as Mr Hundal notes, “[t]here is the practical question of whether the specification as issued can differ appreciably from the specification as filed, given that section 38.2 of the Patent Act does not allow amendments that cannot be reasonably inferred from the specification and drawings contained in the application on its filing date.” Locke JA is right to say that s 27(6) and s 38.2 contemplate amendments to the specification, and they do not expressly exclude amendments which buttress sufficiency. But the “reasonably be inferred” standard from the 38.2 is restrictive, and probably does, as a practical matter, exclude amendments that would cure an insufficient specification. And while Locke JA noted that 27(6) “contemplates amendments to bring the application into compliance with the sufficiency requirements” [33], any such amendments are still subject to s 38.2.

Tuesday, August 30, 2022

Fixed Dosage Regimen is Patentable Subject Matter

Janssen Inc v Pharmascience Inc 2022 FC 1218 Manson J

2,655,335 / paliperidone regimens / INVEGA SUSTENNA / NOC

In this action, Manson J found that Janssen’s 335 patent was not invalid for obviousness or as claiming an unpatentable method of medical treatment. The obviousness decision turned on the facts; the discussion of methods of medical treatment is of more general interest, though it does not break new ground.

This decision followed from Manson J’s prior decision in Janssen v Pharmascience 2022 FC 62, a motion for summary trial, in which he found that Pharmascience’s proposed paliperidone product would induce infringement of the 335 patent [48]: see here. The 335 patent has been the subject of a variety of other litigation, of which the most relevant is Teva Paliperidone 2020 FC 593, in which, as mentioned here, Manson J found that the 335 patent was not obvious, in a decision that turned on the facts.

Paliperidone is a second-generation anti-psychotic, known to be useful in treating schizophrenia. “[S]chizophrenia is incurable and requires life long management with antipsychotic medications. Adherence to a treatment regimen is critical. . . . A leading cause of relapse is non-adherence, where patients do no [sic] take their antipsychotic medication as prescribed, or at all” [11]. One strategy to improve adherence is the use of long-acting formulations. The 335 Patent relates to a long-acting formulation, in particular a dosing regimen for injectable paliperidone palmitate “depot” formulations, which releases from the injection site slowly [12].

Manson J’s analysis on obviousness followed similar lines to his decision in Teva Paliperidone 2020 FC 593: he found the same inventive concept [127] and his findings on the differences between the state of the art and the inventive concept were also consistent with Teva Paliperidone [134]. The key question was whether these differences were obvious. While Pharmascience argued that there were some crucial differences in the evidence on this point between this case and Teva Paliperidone [135], Manson J again concluded that the 335 patent was not obvious or obvious-to-try, in an analysis that turned on the facts [136]–[147]. The key point is that while there was a general motivation to develop a depot formulation of paliperidone to address compliance problems [155], there was not a specific motivation to develop the claimed dosing regimens [153]–[155]. Consequently, the claimed dosing regimens were not obvious [159].

The question of whether the 335 patent claimed unpatentable methods of medical treatment was of more general interest. Manson J noted that the Federal Court and FCA have acknowledged that the jurisprudence as to what constitutes an unpatentable method of medical treatment is inconsistent [161]. He noted, helpfully, “there appears to be no question in the case law that claims to a vendible product are patentable as not being methods of medical treatment” [163]. Many of the claims at issue were “product” claims, in particular claims to prefilled syringes (claims 1 to 16) and Swiss-type claims (claims 33 to 48), and consequently clearly do not constitute unpatentable methods of medical treatment [163]. It is worth noting that Manson J expressly stated that the Swiss-type claims are “product” claims [109]; his holding in Hoffmann-La Roche v Sandoz 2021 FC 384, [95]–[109], that the Swiss-type claims should be construed as use claims now appears to be an outlier: see also my recent post on Janssen v Apotex 2022 FC 996.

The question therefore only arose in respect of the “use”: claims [163]. The justification for the bar on patenting methods of medical treatment is that claims to a method of medical treatment should not constrain a medical professional in the exercise of their skill and judgment: [166], quoting Hospira 2020 FCA 30 [52]. Manson J summarized the law as being that use claims to dosing regimens that are “restricted to particular dosages and specific administration schedules” have been found to be patentable subject matter, “whereas claims to dosages or schedules with ranges within which the physician must exercise skill and judgment have been found to not be a vendible product and thus not patentable” [164]. This is a point Manson J has made before, in Hoffmann-La Roche v Sandoz 2021 FC 384. As discussed here, I’m not sure that distinction entirely reconciles the cases; and Manson J immediately went on to note that claims involving dosage ranges have been held unpatentable “at least in some cases” [165]. Moreover, Manson J evidently does not consider the distinction to be sound in principle, saying the distinction “seems to have a questionable underpinning in resulting judgments based on this dichotomy” but “nevertheless that is where we are under the current state of decisions up to and including decisions in the Federal Court of Appeal” [165]. In other words, we can all recognize that the current state of the jurisprudence is unsatisfactory, but it is what it is, at least for now.

Despite the very confused state of the law, this turned out to be a relatively easy case. The use claims were to a very specific dosing regimen, with “no choices in respect of possible ranges for the dosage amounts, which are fixed at loading doses of 150 mg-eq. on Day 1, 100 mg-eq. on Day 8, and 75 mg-eq thereafter as the maintenance dose” [168]. These are the types of claims that have consistently been held to be patentable subject-matter. Manson J noted that while there was some flexibility in dosing windows, “those choices do not have clinical implications,” as they were incorporated into the regimen to allow for a missed dose, or for convenience in the injection site [170].

Manson J made two observations of general interest. First, as the FCA pointed out in Hospira [52], quoted at [166], “It would seem that a medical professional will be constrained in their exercise of skill” whether the patent claims a fixed dosage or a range of dosages. That is, if a medical professional decides, in their professional judgment, that a certain dosage is required, and that dosage is claimed in a claim to a fixed dosage, their skill will be constrained as much as if it fell within a claimed range. Manson J noted that, in this case, the use claims “do not prevent physicians from practicing in a manner they had previously ‘because they weren’t doing anything before’ the 335 Patent with paliperidone palmitate to treat schizophrenia” [167]. Note the shift from asking whether the medical professional is constrained in the exercise of their skill and judgment, to asking whether they are constrained from practising in the manner they had previously. It seems to me that the medical professional will never be prevented from practising in the manner that they had previously in any case in which the claim is not invalid for anticipation. A valid patent does not constrain a physician’s choices as compared with what they were doing previously; on the contrary, it expands their choices by disclosing new information about how to best treat patients, which would not have been available but for the lure of the patent.

Manson J also noted that “A physician can choose to implement a claimed specific dosing regimen or not; however, skill and judgment are not required to implement the claimed dosing regimens” [171], and for that reason, the claimed subject-matter was not an unpatentable method of medical treatment. This observation also illustrates that the exercise of skill and judgment is always required in medical treatment, even in the administration of a fixed dosage regime. If the exercise of skill and judgment in deciding whether a particular regime is appropriate is not objectionable, I have difficulty seeing why it is any more objectionable if some skill and judgment must be exercised in deciding the exact dose within a claimed range.

Friday, August 26, 2022

ONCA Affirms that PM(NOC) Statutory Stay Damages Regime is a Complete Code

Apotex Inc v Eli Lilly Canada Inc 2022 ONCA 587 affg Apotex v Eli Lilly 2021 ONSC 1588

2,041,113 / olanzapine / ZYPREXA

Under the patent linkage system established by the PM(NOC) Regulations, a patent that is ultimately held to be invalid can keep competitors off the market for two years by operation of the statutory stay pursuant to s 7(1)(d). If the generic prevails, s 8 provides a remedy in the form of damages for the losses suffered from having been kept off the market by the statutory stay. One well-established limitation to s 8 damages is that if the generic is unsuccessful in the NOC proceeding, it cannot claim s 8 damages, even if the patent is subsequently held invalid in an infringement action: 2013 FCA 282 (here). So, Lilly had prevailed in NOC proceedings against Apotex based on the 113 patent (2007 FC 455 affd 2008 FCA 44), but that patent was subsequently declared invalid in separate proceedings (2011 FC 1288 affd 2012 FCA 232). Because Apotex lost in the NOC proceedings, it was not entitled to s 8 damages. In this action, Apotex sought to recover damages for having been kept off the market on the basis of three other causes of action: breach of the Ontario Statute of Monopolies; s 7(a) of the Trademarks Act; and common law conspiracy in restraint of trade [34]–[36]. As discussed here, Schabas J, at first instance, dismissed the action on a motion for summary judgment, holding that none of these causes of action raised a genuine issue for trial. The ONCA has now affirmed, essentially holding that Schabas J was correct on all points. I won’t go through the decision in detail. Instead, I’ll summarize and point out some highlights.

The first point is that the NOC Regulations are a “complete code.” Well, they’re not actually a complete code, as Apotex pointed out [36], but the real point of Schabas J’s decision is that the Regulations are “a complete code” for the purposes of determining whether damages were available to Apotex for having been kept off the market as a result of the operation of the Regulations; and for that purpose, they are a complete code [37], [39].

Second, Schabas J held that Lilly cannot be made liable for exercising its statutory rights [ONSC 113]–[118]. The ONCA agreed:

[42] Eli Lilly is not liable for actions that it was authorized by law to take and for harms that were caused by the operation of the patent regime that Apotex invoked. Absent abuse of process, which was not alleged or found here, Eli Lilly was entitled to pursue the legal process provided for under the PM(NOC) Regulations.

This is probably the most significant general holding of law in this decision. As I noted in my post on Schabas J’s decision, it is broadly similar to the US Noerr–Pennington doctrine. The Noerr–Pennington doctrine has found application in a variety of contexts in US law: see Gugliuzza, Patent Trolls and Preemption, (2015) 101 Va L Rev 1579, 1611–12. It will be interesting to see if this holding takes on a life of its own in the Canadian context.

The Statute of Monopolies point turned on Apotex’s argument that the Statute of Monopolies only exempts valid patents from actions for damages [44]. But, on its face, the Statute “does not distinguish between valid and subsequently invalidated patents” [47]. The ONCA further explained that:

Parliament passed the Statute of Monopolies in an attempt to limit abuses by the Crown in granting “letters patent”, not “patents of invention”. The Statute was passed in response to the Crown granting letters patent to operate or regulate industries, or to have others act as agents of the Crown in operating monopolies for trade and industry, independent of merit or invention.

The ONCA did not cite any authorities on this point. It is more confident than I might be as to the purpose of the Statute, and of course patents of invention are, or at least were at the time, letters patent, so that distinction is a bit strained. But that doesn’t really make any difference given the basic point that the Statute does not distinguish between valid and invalid patents.

The Trademark claim turned on the notion that Form IV filed by Lilly to list the 113 patent on the register was misleading because the 113 patent was invalid. However, all statements made by Lilly were true at the time it made them [51].

The conspiracy claim was struck because Lilly committed no unlawful acts; Lilly was entitled to seek and obtain a patent and list it on the Register: [53].

The ONCA also affirmed a very substantial cost award in Lilly’s favour on a deferential standard of review, after taking the opportunity to review the relevant principles of costs awards. The discussion might be useful to lawyers more familiar with Federal Court practice who are involved in litigation in the Ontario courts.

Wednesday, August 24, 2022

Obscure Prior Art Less Likely to be Combined

Google LLC v Sonos, Inc 2022 FC 1116 Zinn J

            2,545,150 / Adaptive Echo and Noise Control

This brief decision is notable for providing further clarification of how obscure prior art is to be treated in the context of an obviousness attack.

Various “virtual assistants” such as Alexa or Google Assistant, respond to voice commands that may be picked up by a range of smart appliances, such as Sonos’s well-known home audio speakers. Google’s 150 patent relates to a system of echo cancellation and noise suppression in which the order of echo cancellation and noise suppression is adaptively determined based on an amount of noise in the received signal [86]. Google brought this action alleging that Sonos’s smart speakers infringed. In defence, Sonos disputed infringement and alleged invalidity based on obviousness.

As is often the case, much turned on claim construction. A preliminary issue was whether recourse to the disclosure is always permitted or is permitted only when the claims are ambiguous. Biogen v Pharmascience 2022 FCA 143, released only a week before, settled that recourse to the disclosure is always permitted. While Zinn J would not have had the benefit of Biogen v Pharmascience, he nonetheless came to a consistent conclusion after reviewing the recent FC caselaw [42]–[44].

A key point on the facts was whether “echo cancellation” is a subset of “noise suppression” or whether the two are mutually exclusive [47]. Zinn J concluded that the two were distinct, in an analysis that turned primarily on a purposive reading of the patent as a whole, rather than on the expert evidence: see [50], noting that the two must be distinct to give meaning to Claim 7; and [51], noting that the two are treated as distinct throughout the disclosure. Zinn J’s construction of other contentious claim elements turned largely on the expert evidence.

Zinn J held that Sonos did not directly infringe because the allegedly infringing features were disabled on delivery [65], so that infringement could only be established by inducement. But he also had no difficulty in concluding that if the user infringes, that infringement will have been induced by Sonos [67]–[69], so infringement simply reduced to whether the user would infringe [70]. He answered this question in the negative, in an analysis that turned entirely on the evidence [81].

The obviousness inquiry was originally taken to be an essentially factual inquiry as to whether the invention would have been obvious to a person skilled in the relevant art. From this, it follows directly that the state of the art relevant to an obviousness attack does not comprise the entire body of publicly available information, but only that information which would actually be available to the skilled person. When the non-obviousness requirement was codified in s 28.3, it provided that obviousness is to be assessed in light of information disclosed “in such a manner that the information became available to the public in Canada or elsewhere.” On its face, this states that the entire body of public information constitutes the state of the art. The question then was whether codification was intended to change the law on this point, and if so, what the specific effect of the change was. In Hospira 2020 FCA 30, discussed here, the FCA held that “it is an error to exclude from consideration prior art that was available to the public at the relevant date simply because it would not have been located in a reasonably diligent search” but at the same time “The likelihood that a prior art reference would not have been located by a [person skilled in the art] may be relevant to consideration of step 4 of the obviousness analysis (whether differences between the state of the art and the inventive concept constitute steps which would have been obvious to the PSA) in that the uninventive PSA might not have thought to combine that prior art reference with other prior art to make the claimed invention” [86]. As I noted in my post on Hospira, this suggests that there can be no mosaicing of prior art that is not available in a reasonably diligent search. However, the FCA’s comments in Hospira were brief, as the Court remanded the issue for reconsideration.

The issue of obscure prior art arose in this case because a key element of prior art was the US patent 5,668,871. The 871 patent was very clearly obscure prior art—which is to say, prior art that would not have been found in a reasonably diligent search; it was not known to either expert prior to the litigation, nor was it found by either expert during their preparation, “despite their personal familiarity with the field and despite [Sonos’s expert] having conducted a diligent search” [92].

Google argued that the 871 patent was not eligible prior art for the purposes of the obviousness attack for that reason. Zinn J rejected this argument on the clear authority of the above-quoted paragraph 86 of Hospira [96].

The question then is how the obscure prior art may be used. Zinn J pointed out that “the difficulty of locating a document is a matter that may be considered at the final step,” relying on the same passage from Hospira [97].

[98] The question thus becomes whether, given the obscure nature of the 871 Patent, the uninventive POSITA might have thought to combine the 871 Patent with other prior art to make the claimed invention.

On the facts, Zinn J held that “given the difficulty in locating the 871 Patent, that the POSITA would not have been led directly and without difficulty to combine these references” [105], and he consequently rejected Sonos’ argument that the 150 Patent was obvious based on “any combination involving the 871 Patent” [106]. I must say that it is not clear to me exactly which references in addition to the 871 patent Zinn J was referring to as “these references” but I take it the other references were part of the prior art, but not part of the common general knowledge.

Google had relied on Kane J’s statement in Teva v Pharmascience 2020 FC 1158 [796], to the effect that “the prior art relied on by Pharmascience would not all have been found by the POSITA,” affd 2022 FCA 2 (Locke JA) [32] noting that Kane J “was apparently concerned that, given the difficulty in locating certain prior art, the PSA would not have been led directly and without difficulty to combine these references.” Zinn J considered that Locke JA was not contradicting his own prior statement in Hospira but was simply saying that “the difficulty of locating a document is a matter that may be considered at the final step” [97]. I think this is right, considering Kane J’s statement at [801] that “I agree with Teva that Pharmascience has not explained how or why the POSITA would regard these pieces of prior art together in a mosaic to lead to the invention,” and moreover “even if the POSITA was handed this mosaic, it does not lead them directly to the subject matter of the claims.” So, I don’t see any inconsistency.

Zinn J’s decision is consistent with Fothergill J’s decision in dTechs 2021 FC 190 (see here). However, it is possible that it diverges from Manson J’s decision in Biogen v Taro 2020 FC 621; in my post on Manson J’s decision I suggested that his analysis was notable for making a mosaic of obscure prior art. Manson J’s decision holding the patent at issue invalid for obviousness was just affirmed by the FCA in Biogen v Pharmascience 2022 FCA 143 [143]–[171]. However, the FCA decision did not address this issue; the main ground of appeal was that Manson J had failed to adopt the mantle of the POSITA, essentially by failing to recognize that the skilled person in the field would be highly skeptical of any new alternative treatments that were not supported by double-blind, placebo-controlled trials [144], [148]. So far as I can see, the issue of mosaicing of obscure prior art was simply not addressed at all. I think the most likely explanation is that I was simply wrong in thinking that the prior art relied on by Manson J was obscure prior art, which would explain why the issue was not raised on appeal. In that case, there is in fact no divergence between these decisions on this issue. In any event, even if Manson J did combine obscure prior art, the fact that the FCA affirmed on obviousness cannot be taken as holding that it is permissible to combine obscure prior art, given that the issue was not discussed. If the FCA had intended any comment on that point, it would surely have discussed Hospira.

Monday, August 22, 2022

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].

Thursday, August 18, 2022

What Is the Date for Assessing Sufficiency?

Pharmascience Inc v Bristol-Myers Squibb Canada Co 2022 FCA 142 Locke JA: de Montigny, Monaghan JJA affg 2021 FC 1 Zinn J FC Selection

2,461,202 / 2,791,171 / apixaban / ELIQUIS

My previous post addressed issues of selection patents raised by this decision. This post discusses the insufficiency attack on the 202 patent, and concludes with a brief discussion of the 171 patent, which reveals another failed attempt to give independent effect to overbreadth as a ground of attack. As described in my last post, the patents in suit relate to the anticoagulant compound apixaban which is used in treating thromboembolic disorders, including stroke. The 202 patent claims the compound apixaban as such, as well as its use in the treatment of thromboembolic disorders [4]. The 171 patent claims various formulations of apixaban. Only validity was at issue.

Insufficiency attack on the 202 patent

Pharmascience argued that the 202 patent was invalid for insufficiency because it did not indicate that the focus of the invention was apixaban at either the filing date or the publication date [22]. Apixaban was merely one of hundreds of examples, and the claims focusing on it were not introduced until shortly before the patent issued [22].

The answer to this argument is that it is the validity of the granted patent that must be considered. Saying that validity on one ground or the other is assessed as of a particular date does not change that. So, when we say that the claims must be novel as of the claim date, we do not mean that the claims as they existed at that date must be novel, but rather that the claims in the granted patent must claim subject-matter that was novel as of the claim date [31]. The same applies to sufficiency: it is the specification of the issued patent that must adequately disclose the invention [32]–[33]. If we say that sufficiency is assessed as of the filing date (of which, more below), that means that the specification as granted must enable a person skilled in art to make the invention in light of their common general knowledge as of the filing date.

Consequently, this point should have been framed as an added matter objection: “[t]he real debate here should be whether the addition of claims specific to apixaban introduced new matter to the specification of the 202 Patent that could not reasonably be inferred from the application as filed” [37]. It was problematic to raise this on appeal without having raised it at trial [37], but in any event, Locke JA noted that an added matter objection probably could not be sustained, as apixaban was specifically described in Example 18 and that would seem sufficient to support the introduction of claims thereto [37].

That all makes sense. But the decision also has a relatively lengthy discussion of the appropriate date for assessing sufficiency. Pharmascience relied on the decision of Hughes J in Zoledronate 2013 FC 283 [179]–[188], which implied that the correct date is the publication date [23]. Locke JA discounted the Zoledronate decision for various reasons (eg the discussion was obiter), without actually saying it was wrong and without specifically stating the law as to the appropriate date for assessing sufficiency [26]–[28]. For example, Locke JA noted that Hughes J did not address the view expressed by MacKay J in Merck v Apotex 59 CPR(3d) 133 (FCTD) that the date of issue is the appropriate date for assessing insufficiency [28], but only by way of indicating that Hughes J’s analysis was incomplete.

This seems a bit strange because, as indicated in my post on Zinn J’s decision, I thought the point was settled in Idenix v Gilead 2017 FCA 161 [46] affg 2015 FC 1156. In that case, the patentee, Idenix, had not actually synthesized any of the claimed compound as of the filing date: see here. Gilead, therefore, made a classic “how to make” insufficiency argument, and Annis J held that the disclosure was not sufficient to allow a skilled person to synthesize the compounds, and held the patent invalid for that reason. This was even though, by the time of trial, the claimed compound could be synthesized by three different pathways [FCA 46]. I’ve taken a look through Annis J’s (very long) decision, and it is not clear to me what date he took to be the appropriate date; the focus of the discussion is on showing that “retrosynthetic analysis”, based on the specification plus routine experimentation, was not sufficient to enable a skilled person to make the claimed compounds. The first public disclosure of how to make the compounds was in January 2005 [FC 501], so the patent would have been sufficient as of that date, at least if the skilled person were taken to be aware of that public disclosure. The 191 patent at issue had a filing date of June 2003 and a publication date of January 2004, so the patent would have been insufficient as of those dates, but sufficient as of the date of issue. This implies that we can at least rule out the date of issue as the appropriate date for assessing sufficiency.

The FCA affirmed the finding of insufficiency saying:

[46] Though reversed on other points, this Court held in [Viagra] 2010 FCA 242 at paragraph 79. . . that courts must “determine whether the disclosure was sufficient as of the date of filing. As a result, anything which occurred subsequent thereto is of no relevance.” In my view, Idenix’s argument reflects the benefit of hindsight rather than the knowledge of the skilled person at the relevant date.

This clearly indicates that the appropriate date is the filing date, though the result is consistent with using the publication date.

I find it peculiar that, in this case, Locke JA did not mention the FCA decisions in either Idenix or Viagra. It is true that neither of those cases analyzes the issue—the statements of the appropriate date are conclusory—while the FC decisions of MacKay J Merck v Apotex and Hughes J in Zoledronate do have an extended discussion. But still, the express statements by the FCA are directly on point, even if not fully reasoned.

I suspect Locke JA chose to avoid Idenix or Viagra because their endorsement of the filing date sits uneasily with his response to Pharmascience’s argument:

[33] [Pharmascience] notes that subsection 27(3) identifies the requirements of the “specification”, and argues that subsection 27(2) indicates that it is the specification as filed that must meet those requirements. However, such an argument does not withstand scrutiny. Firstly, it would effectively read out subsection 27(6), which contemplates amendments to bring the application into compliance with the sufficiency requirements. Secondly, a similar argument would seem to apply to the requirements for novelty (the opposite of anticipation) and inventiveness (the opposite of obviousness). Sections 28.2 and 28.3, which address these issues, both refer to requirements for “[t]he subject-matter defined by a claim in an application for a patent.” PMS’s focus on the specification as filed for determining sufficiency would also imply a focus on the claims as filed for anticipation and obviousness, since the relevant provisions mention “a claim in an application”. I can see no reason that the approach that PMS urges for sufficiency would not apply similarly to anticipation and obviousness.

I’ll take the second point first. It is perfectly clear that novelty and inventiveness are assessed as of the claim date. But it is the claims as granted that must have been new and inventive as of the claim date; there is no requirement that the claims as they existed as of the claim date must be new and inventive. The same point applies to sufficiency. The specification as granted (including any amendments as per 27(6)) must have been sufficient at the relevant time (whenever that is). That means that in assessing the sufficiency of the specification as granted, we must consider whether it would have allowed the skilled person to practice the invention at the relevant date, without the assistance of new techniques or knowledge that emerged after that date. Turning to the first point, saying that the relevant date for sufficiency is the filing date does not read out 27(6). To say that the relevant date is the filing date does not mean that it is the specification as it existed as of that date that must be sufficient, just as saying that the relevant date for utility is the filing date does not mean that it is the claims as they existed at that date that must claim useful subject-matter. It simply means that in assessing the sufficiency of the specification as granted, common general knowledge arising after the filing date cannot be taken into account. (I note also that while 27(6) permits amendments, that is subject to 38.2, which only permits the addition of matter that can reasonably be inferred from the specification as filed. Consequently, I suspect it would be difficult, and perhaps impossible, to amend a specification that is insufficient as of the filing date so as to render it sufficient at some subsequent date. But that is an aside.) So, the fact that claims can change post-filing does not mean that the relevant date for assessing novelty is post-filing; similarly, the fact that the specification may be amended post-filing does not mean that the relevant date for assessing sufficiency is not the filing date.

At the end of the day, I’m inclined to think that the appropriate date for assessing sufficiency is indeed the filing date. But I suppose the fact that the FCA in this case ignored Idenix and Viagra means that the point should now be considered open.

171 patent

The 171 patent relates to a formulation of apixaban with, inter alia, a specified particular size. Locke JA affirmed Zinn J’s holding on the facts that it was not obvious-to-try [39]–[59]. Pharmascience also argued that the patent was invalid for ambiguity on the basis that the method for determining particle size was not specified, and different methods could give different results. Locke JA dismissed this argument, pointing out that the specification did describe a particular measuring method and a skilled person would understand this to be the method to use [66].

Finally, Pharmascience made an overbreadth attack. In Seedlings 2021 FCA 154 (blogged here) the FCA affirmed that “overbreadth remains a proper ground of invalidity” [50]. Consequently, we are now seeing overbreadth raised regularly as a ground of invalidity. But parties attacking the validity of a patent have struggled to find an approach to overbreadth which gives it any independent force. This case is another example. Locke JA remarked that “The nature of [Pharmascience’s] argument on overbreadth of the 171 Patent is not entirely clear” [69]—which is not entirely surprising, given that the concept of overbreadth itself is not clear. In any event, Locke JA’s discussion was brief, so I’ll just note that Locke JA, after dismissing it on the facts, indicated that the attack “would seem to relate to the sufficiency of the 171 Patent, rather than overbreadth” [71]. Another attempt to give some effect to overbreadth as an independent ground of invalidity has failed.

UPDATE: see my follow-up post on the date for assessing sufficiency.