The Limits of Sufficiency

Allergan Inc. v. Juno Pharmaceuticals Corp 2023 FC 1686 Pentney J

2,585,691 / bimatoprost formulation / LUMIGAN RC / NOC

Glaucoma and ocular hypertension are serious medical conditions that can lead to blindness. It can be controlled by medications which lower the pressure inside the eye, referred to as intraocular pressure (“IOP”) [4]. “[T]aking glaucoma medication is boring, because it requires a daily dose of one or more medications, often for the rest of a person’s life. And the patient will usually not notice any improvement in their vision, because the medication is actually only stopping further decline” [48]. For this reason, patient compliance is very important. (I must say that I enjoyed Pentney J’s lucid discussion of the physiology of the eye and drug transport through it [29]–[49]. One of the reasons I specialize in patent law is that the science is interesting and Pentney J’s discussion was particularly clear and informative.)

Allergan’s old LUMIGAN product was used to treat IOP. It contained 300 ppm bimatoprost, the active ingredient, and 50 ppm BAK, a preservative. It was successful in lowering IOP but had unwanted side effects, which impacted compliance. “Allergan therefore sought to develop a formulation that was similarly effective in lowering IOP but did not cause the unwanted side effects” [17]. The result was the claimed invention, embodied in LUMIGAN RC, which contained 100 ppm bimatoprost and 200 ppm BAK—that is, it had less of the active ingredient and more preservative.

The main question was whether this formulation was obvious. Pentney J helds on the facts that it was not. While reducing the concentration of bimatoprost might be expected to reduce side effects, the skilled person would also expect it to reduce efficacy [203]. While BAK is generally safe at the levels in both the old and new formulations, there was nonetheless a trend to decreasing BAK levels, to minimize its potentially inflammatory and cytotoxic effects [241], [243]. The key to the formulation is that BAK also worked as a “penetration enhancer” which meant that the lower amount of bimatoprost in the claimed formulation achieved equal or better IOP reduction than old formulation [245]. This effect was not obvious. It was known that BAK could be a penetration enhancer for some molecules, in particular hydrophilic molecules, but it was not expected to be a penetration enhancer for lipophilic substances such as bimatoprost [302]–[305]; and see [319]. Consequently, Pentney J found the claimed formulation was not obvious after an obvious-to-try analysis [380]–[382].

There was a fairly extended discussion of the inventive concept and whether it should be determined from the claims alone or by considering the disclosure as well. Pentney J rejected an approach based on the claims alone, noting that Shire 2021 FCA 52 [72] held that it is necessary to turn to the specification, at least in the case of a claim to a chemical compound [158]. Pentney J noted that Shire was particularly pertinent to the case at hand [153], because a chemical formulation is no different from a chemical compound in that respect. Consequently, Pentney J embarked of a fairly lengthy examination of the disclosure in light of the expert evidence in order to identify the inventive concept.

I won’t go through his discussion in detail, but I will point out that looking at the claims and looking at the specification are not the only two possible choices. The problem with looking at the claims is that a claim to a compound does not tell us what the inventive step was: the compound might be easy to synthesis, but with no previously known use, in which case identifying the use might be inventive. Or a compound might be known to be useful, but difficult to synthesize (eg early biologics), in which case the method of synthesis might be the inventive step. We cannot tell which by looking at the claims alone.

The problem with looking at the disclosure to determine the inventive concept is that the inventor does not always know what they have invented, because the inventor does not normally know all the prior art, and may well not know the entire state of the art (which now includes all the prior art). So, the inventors who discovered that sildenafil could be orally administered to treat ED because it was a PDE V inhibitor, thought their real discovery was that PDE V inhibitors can be orally administered to treat ED, but in fact at least one was already known (epimedium aka ‘horny goat weed’ aka ‘yin yang huo’). Consequently, all they really discovered was that sildenafil can be orally administered to treat ED. If the inventors do not know what they have discovered, they might not identify the true inventive concept in the disclosure.

In my view, elaborated at more length in my post on Shire, the focus should be on the solution to the objective problem facing the inventors. In this case, the objective problem, identified in Pentney J’s discussion of the facts, was “to develop a formulation that was similarly effective [to the old Lumigan] in lowering IOP but did not cause the unwanted side effects” [17]. The question should be whether the claimed invention was an obvious solution to that problem. This didn’t make any difference on the facts, because in this case the inventors were essentially correct about what they had invented, and so the inventive concept derived from the specification was more or less the same as the objective inventive concept — similar enough to make no difference in the obviousness analysis [181]. But that will not always be true.

Pentney J also dismissed four insufficiency attacks in brief reasons. It was clear that the specification disclosed sufficient information to allow the skilled person to make and use the invention [390] and all four attacks were premised on the incorrect idea that sufficiency somehow requires more than that.

First, Juno argued that the patent failed to disclose information which would allow the skilled person to conclude it was safe for human use [386]. Pentney J pointed out the claim doesn’t say anything about the safety profile, so failure to disclose any such information is irrelevant [391]. Further, “It is well-established in the jurisprudence that the standard required to obtain a patent cannot be equated to that needed to obtain regulatory approval” [391] quoting Novo Nordisk v Cobalt 2010 FC 746 [352].

Second, Juno argued that the patent “fails to fully describe the advantage of the 0.01% dose formulations to enable the POSITA to understand its benefits over old LUMIGAN” [386]. Pentney J dismissed this by saying “I find that the specification in the 691 Patent, and in particular the data shown in the examples, is sufficient to establish that the formulation in Claim 16 would deliver comparable or better IOP reduction as compared to old LUMIGAN, and that is all that is required” [393]. I’m sure that even that much is required. The claim is simply to a formulation. The claim says nothing about its benefits, namely increased efficacy with reduced side effects. I don’t see why the specification has to establish comparable efficacy; it’s enough that the specification discloses how to make and use the invention so as to achieve whatever benefits it might have.

Third, Juno argued that the disclosure was insufficient because it did not disclose that the 200 ppm BAK served as a penetration enhancer [395]. Pentney J dismissed this on the basis that “a patent does not have to explain how the invention works as long as it explains how to work the invention” [395]. That is a straightforward application of Consolboard [1981] 1 SCR 504, which Pentney J cited.

Finally, Juno argued that “since Allergan has asserted that data based on rabbit studies cannot be directly extrapolated to the effects on humans, the Patent’s disclosures regarding permeability are not sufficient” [386]. This strikes me as another version of the third argument, arguing that the patent must disclose why the invention works. Pentney J dismissed it for similar reasons.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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.

Arbitrary Selection?

Merck Sharp & Dohme Corp v Pharmascience Inc 2022 FC 417 Furlanetto J

            2,529,400 / sitagliptin phosphate salt form / JANUVIA / NOC

The key claim at issue in Merck’s 400 patent, Claim 4, is to the crystalline monohydrate form of the dihydrogenphosphate [DHP] salt of sitagliptin, which is used to treat type 2 diabetes [1], [12]. The closest prior art is PCT application WO 03/004498, which disclosed a genus of compounds, specifically exemplifying sitagliptin, among other compounds, both as a free base and hydrochloride salt [11]. The crystalline monohydrate DHP salt was evidently not specifically disclosed.

Pharmascience argued that the 400 Patent is invalid for obviousness and/or insufficiency [3], [64]. The insufficiency attack was a straightforward “how to make” argument, alleging that the disclosed process details were not sufficient to allow a skilled person to make the crystalline monohydrate [255]. This attack failed on the facts: [277–78].

The more interesting attack was obviousness. Given that sitagliptin was specifically disclosed in WO498, the inventive step lay in selecting sitagliptin as the lead compound from the other compounds, or in selecting the salt form, or in the combination of those decisions. As I see it—and this is not the way Pharmascience expressed it—the basic case for obviousness is that Merck just chose sitagliptin arbitrarily from the compounds disclosed in WO498, then did more or less routine salt screening to come up with a salt form with reasonable stability and manufacturing properties.

Suppose a genus patent discloses a class of compounds as having certain useful properties, such as utility in treating diabetes. There is no invention in picking one compound at random from the genus and showing that it is useful in treating diabetes; the genus patent told of us that all members of the genus are useful for that purpose, and the compound is a member of the genus, so of course it is useful in treating diabetes. This is known in European law as an “arbitrary selection”: see Dr Reddy's [2009] EWCA Civ 1362 [44]–[52]; and see Actavis v ICOS [2019] UKSC 15 discussed here. While the term “arbitrary selection” is not as commonly used in Canadian law, the same principle has been recognized in Canadian law: see Teva v Janssen 2018 FC 754 [198], Locke J, expressly noting that arbitrariness is not inventive; Millennium v Teva 2019 FCA 273, applying the principle; Janssen v Teva 2015 FC 247, also applying the principle. This is why a selection must have some special property over what is already known about the genus: this is not a matter of special rules applicable to selection patents, but simply a reflection of the fact that if the selected compound has no advantage, then it is not inventive to select it. Supose I hand you a bag, saying “This is full of red rocks” and I pull out a handful of rust-coloured pebbles of various shapes and sizes to show you. If you reach into the bag yourself and pull out another rusty pebble, no one will be surprised. Now, I can’t predict in advance exactly which rusty pebble you will take from the 100s in the bag—precisely because the selection is arbitrary. An arbitrary selection is both uninventive and unpredictable at the same time.

I don’t see much in Furlanetto J’s decision to suggest that the selection of sitagliptin was anything other than arbitrary. She states:

[203] The evidence indicates that the [skilled person] would not have any specific motivation arising from WO498 to focus on the particular crystalline form of a salt of sitagliptin over the other compounds disclosed within WO498.

But an arbitrary selection is exactly one where there is no particular motivation to pick the compound over the other compounds of the genus, precisely because one is as good as the other.

Furlanetto J also noted that “In June 2003, the only publication on sitagliptin was WO498. There was no indication as to its activity, efficacy, toxicity or tolerability. Further, the general level of potency reported in WO498 indicated a level of potency that was 45 to 167 times less than [another compound known in the prior art]" [210]. This was generally in a support of a “teaching away” argument. But teaching away is evidence of non-obviousness when the compound that was disparaged is subsequently discovered to have exceptional properties. I don’t see anything to that effect in Furlanetto J’s discussion.

Furlanetto J concluded

[212] There is no evidence that the PSA would be drawn to sitagliptin as a starting point for further development. On the basis of the prior art, it cannot be concluded that there was motivation for anyone other than Merck to move forward with sitagliptin as a lead compound.

Again, this is consistent with saying that Merck selected sitagliptin arbitrarily.

I’m not saying that the selection was arbitrary; only that the decision doesn’t identify this possibility and explain why it’s not. I think part of the reason for this is the focus on the inventive concept. Of course, the Windsurfing / Polozzi framework invites us to identify the inventive concept, but it is now recognized that this can be treacherous, with the FCA having wrestled with the question of whether a focus on the inventive concept is unhelpful, helpful or necessary: see here, here and here. This is a context where it seems to have been unhelpful. Pharmascience argued that “the choice of sitagliptin as the starting point does not form part of the inventive concept” [207]. Once we decide that it is, the question becomes whether that was obvious, and that leads to the asking whether it was predictable, which, in my view, is the wrong question.

The question might have been addressed with an objective problem-and-solution approach, in which case the issue of arbitrary selection would have been addressed in identifying the objective problem. Or it might have been addressed simply by asking is whether there was an inventive step involved in choosing sitagliptin.

There is also the old IG Farbenindustrie (1930) 47 RPC 289 (Ch) in Sanofi 2008 SCC 61 [10]–[11] approach to selection patents. Furlanetto J had a fairly long discussion of whether the claimed invention was a “selection patent” over WO498 invention of [77]–[95]. While she recognized that the validity requirements are the same either way, she expressed the view that this assists the Court “in understanding ‘the nature of the beast’” and makes it “easier to compare the facts of the particular case before the court with other previous fact scenarios” [80]. Ultimately she decided that it was a selection, but this doesn’t seem to have played any important role in the obviousness analysis.

In particular, she didn’t mention the IG Farben factors. There is good reason for this omission. The IG Farben factors have fallen out of favour, for two main reasons. First, as Rennie JA pointed out in Apotex v Shire 2021 FCA 52 [32] “A selection patent is subject to the same requirements and vulnerable to the same attacks as any other patent, including attacks based on anticipation and obviousness.” The IG Farben factors must therefore either be duplicative of standard grounds of attack, or wrong. And, as discussed here, the second and third IG Farben factors are arguably wrong, or at least problematic—though these factors were rarely if ever actually used to strike down a patent.

So there are good reasons to avoid the IG Farben approach. With that said, there is a reason the IG Farben factors were used for so long. It is the first factor that was almost always the crux of the analysis:

1. There must be a substantial advantage to be secured or disadvantage to be avoided by the use of the selected members.

This factor is a convenient way of expressing the inventive step requirement in the context of selection patents. It directly addresses the problem of arbitrary selection. As just discussed, if an entire genus has certain properties, it is obvious that any member of the genus will also have those properties. There is no invention in reaching into the bag of rocks and pulling out a rusty pebble; but if you rummage around and pull out a ruby, to everyone’s astonishment, that deserves a reward. The “advantage to be secured or disadvantage to be avoided” is the extra ingredient ensures the patentee has extracted a ruby from the bag, and not another red rock.

So, while the first factor is strictly redundant, in the sense that it simply encapsulates the inventive step requirement, it nonetheless poses that requirement in the context of selection patents in a way that is perhaps more helpful than the Windsurfing / Pozzoli focus on the inventive concept.

There seems to be more of a case that the development of the crystalline monohydrate form of the DHP salt was inventive, as there was a significant amount of work involved. But it seems that it was routine to develop the DHP salt [226]–[229], which was suitable for tableting. Developing the particular crystalline monohydrate form was challenging, but it is not clear to me that it offered significant advantages over the DHP. What was the problem solved by the crystalline monohydrate? It was difficult to develop, but if it did not solve any problem, in what way was it inventive? I have to admit that I came away with the nagging feeling that the inventors developed the DHP salt, and its properties were just fine, but they kept on going to develop something more difficult, just because they knew that the routine work to develop the DHP salt would not support a patent. There’s nothing in the decision that I can point at to support that notion, but I don’t see anything to rule it out, either. If that’s right, this is different from arbitrary selection, since the crystalline monohydrate was difficult to develop, but it’s still not clear to me that it’s inventive. Arbitrary selection is reaching into the bag and extracting a random rock that has the same properties as the others that were already known; inventive selection is rummaging painstakingly through the bag to find the single ruby; developing the crystalline monohydrate seems to have been like rummaging painstakingly through the bag to find the rusty rock that is most nearly spherical, even though being spherical offers no practical advantage over any other shape. One may at least question whether that is deserving of a patent.

Ultimately, even accepting all of Furlanetto J’s factual findings, I am having difficulty putting my finger on the inventive step in this invention. Assuming I’m not just missing the something, this strikes me as problematic. We need a doctrinal framework to guide the analysis, but in the end, a good framework should do more than simply generate an answer—it should help us understand the nature of the contribution that deserves the reward of a patent. I don’t see anything specifically wrong doctrinally with Furlanetto J’s analysis, and I suspect that ultimately my difficulty lies with the way the problem has been framed, with the focus on identifying the inventive concept.

“Disclose” Has the Same Meaning in Claim Date and Novelty Provisions

Paid Search Engine Tools, LLC v Google Canada Corporation 2021 FC 1435 McDonald J

2,415,167 / Paid Search Engine Bid Management

In this decision, McDonald J held all the asserted claims of PSET’s 167 patent were invalid for insufficiency, anticipation, or obviousness [5] in a decision that turned largely on the facts. (If I’m counting right, PSET asserted 64 claims from 6 independent claims.)

The patent relates to a system for search engine bid management. In the early 2000s advertisers were reaching internet users by paying search engines to have their information or advertisements displayed in response to user searches for sites for specified keywords. Advertisers could bid on search keywords, so that a higher bid would get the advertiser a higher place in the search results for that keyword [11]. Advertisers wanted to manage their bids to get the best placement for the least money. This could be cumbersome for an advertiser managing a large number of keywords. The inventors of the 167 patent developed what they called a Keyword Bid Optimizer tool (KBO). The KBO collected information from the search engine on their customers’ keywords and the bids on those keywords, and produced a report showing: the keyword(s), the number of times it was searched (views), the top 20 bids for the keyword, and where the advertiser’s bid (in red) ranked relative to others, as shown in this figure from the patent [17]:

With the report in hand (or on-screen), the advertiser could then easily scan the table and see, for example, that they could reduce their bid on “earth friendly product” from 5¢ to 4¢ while still maintaining their first place ranking. The claimed invention seems to have been an automated version of the KBO tool, which incorporated automatic bid reduction as an essential element [236].

McDonald J held on the facts that two of the key independent claims (1 and 17) were undoubtedly obvious:

[260] This is not a case where the application of the obviousness analysis strains credulity. The evidence is clear that even on a rigid application of the obviousness considerations there were multiple other commercial products that performed the same essential features, and in some cases more, as those described in claims 1 and 17 of the 167 Patent.

This is a classic obviousness scenario, where the development of a new product or technology drives a demand for complementary technologies. There were no doubt many new and useful products that were nonetheless obvious, as companies rushed to pluck the low hanging fruit from the new opportunities opened up by search engine advertising, which was relatively new at the time [62].

A number of the claims were also anticipated. The 167 patent claimed priority from a US provisional patent application, which was referred to as the 976 patent. McDonald J held that a number of the claims were not entitled to claim priority from the 976 patent as the claimed invention was not sufficiently disclosed [222]. PSET argued that the claim to priority is met “if an ‘inference’ can be drawn that the 976 Patent discloses the 167 Patent” [220]. McDonald J rejected this, pointing out that “The word “disclose” appears in various sections of the Patent Act. I do not accept that a different meaning should apply to disclosure as it is used in subsection 28.1(1) such that disclosure is achieved merely if an inference can be drawn” [221]. This holding strikes me as clearly correct. Section 28.1(1), the claim date provision, refers to “a patent disclosing the subject-matter defined by the claim”; s 28.2(1), the novelty provision, states “The subject-matter defined by a claim . . . must not have been disclosed.” It is not just the word “disclosed” that is the same; the two provisions have parallel construction, both dealing with the relationship between disclosure and the claimed subject matter, and of course the claim date defined in s 28.1(1) is incorporated into s 28.2(2). Surely the same meaning was intended. PSET conceded that many of the asserted claims were anticipated if they could not rely on the priority claim [231]. Other claims were anticipated by the prior art [245].

McDonald J also held that a number of the claims were not sufficiently disclosed, particularly those based on automatic reduction of a bid based on the demographic information of searchers, as the patent did not provide sufficient description of how to actually use that information: see eg [199], [204]. In effect, patent says “Check out these cool stats and then optimize.” We don’t see successful insufficiency attacks very often, but this strikes me as a pretty clear case, at least judging from McDonald J’s relatively brief discussion.

Finally, I’ll note that the patentee appears to be a variety of patent assertion entity. PSET did actually implement and sell the KBO tool, but it was not commercially successful, and they stopped selling it in 2003 [20]–[22]. As noted, the invention claimed by the 167 patent is an improved version of that tool, with automated bid adjustment, and it doesn’t seem that PSET ever implemented an embodiment of the invention. So far as I can tell, PSET was one of many firms that jumped into an exploding new market, but they didn’t survive the shake out. This litigation was an (unsuccessful) attempt to monetize the patent.

 UPDATE: See further discussion of the priority point here.

Squeezing Through the Utility / Obviousness Gap

Pharmascience Inc v Teva Canada Innovation 2022 FCA 2 Locke JA: Stratas, Monaghan JJA affg 2020 FC 1158 Kane J

2,702,437 / 2,760,802 / glatiramer acetate / Copaxone / Glatect / NOC / FC Anticipation

In this decision, Locke JA, writing for the FCA, affirmed Kane J’s holding that the 802 patent was valid and that it would be infringed by Pharmascience’s generic product. The 802 patent at issue in this case relates to the use of glatiramer acetate for the treatment of multiple sclerosis, and in particular a dosing regime of 40mg three times a week [11]. Pharmascience argued that the 802 patent was invalid either for lack of sound prediction of utility or obviousness. (Kane J’s holding that the 447 patent was novel, but invalid for obviousness, was not appealed.)

Locke JA’s decision of sound prediction began by mentioning the putative enhanced disclosure requirement for utility based on sound prediction, which would require the factual basis for the sound prediction to be disclosed in the patent itself.* However, it was not necessary for Locke JA to engage with this issue because he found that Kane J had not in any event relied on a factual basis that was not disclosed; her holding that a sound prediction of utility was established was based on the common general knowledge and the logic disclosed in the specification [21]–[22].

This gave rise to a squeeze: “Pharmascience argues that, if the common general knowledge was sufficient to support a sound prediction of utility of the invention of the 802 Patent, then the same common general knowledge would make the invention obvious to try, and therefore invalid for obviousness” [6]. Locke JA rejected the squeeze on the basis that there is a gap between the two requirements:

[38] There is no necessary inconsistency between the finding, on the one hand, that an idea is sufficiently described in the patent disclosure and the common general knowledge to support a sound prediction that it will be useful. . . and, on the other, that the idea is not sufficiently known in the prior art (including but not limited to the common general knowledge) to lead the PSA directly and without difficulty to the solution taught in the patent.

In effect, an expert might say “I would never have thought of trying that, but now that you mention it, yes, I would say that it would probably work.” This makes sense to me, particularly in a case where the inventive concept lies in the insight that a particular approach is worth trying.

*Locke JA prefaced his comments by noting that “the parties do not disagree on the question of whether there is indeed a heightened disclosure requirement applicable to inventions based on sound prediction. Accordingly, it is not necessary to comment on that question here” [16]. I take this to be saying that he is not commenting on whether the law actually requires a heightened disclosure requirement. But in the next paragraph he went on to say that “In my view, the Trial Judge did not misunderstand the disclosure requirement under the sound prediction doctrine” [17]; this evidently says she was correct, not just that it was not necessary to address whether she was correct, given that the parties were in agreement. Locke JA contined by saying “at paragraph 874, she discussed the disclosure requirement specific to the context of the doctrine of sound prediction,” quoting from Eurocopter 2013 FCA 219 [153], which is ambiguous, at least as I read it. I find all this a bit opaque, but it at least seems clear that this decision does not change anything one way or the other in respect of the putative heightened disclosure requirement.

Double Patenting over Published Prior Patent

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

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

As I mentioned in my first post on this decision, Roche’s 997 patent was found to be invalid for obviousness-type double patenting over Roche’s 654 patent [148]–[153], even though the publication date of the 654 patent, June 26, 2008, was before the claim date of the 997 patent, November 10, 2008 [9], [11], [153], so the 654 patent was prior art over the 997 patent. In my first post, I didn’t make much of this point. I just said that I was “a bit puzzled” as to why the argument was run on a double patenting basis, given that the 654 patent was prior art over the 997 and so, under Hospira 2020 FCA 30, would have been part of the state of the art against the 997 patent. I suggested that “Perhaps Sandoz felt it was safer to use double patenting rather than to rely on the Hospira doctrine—presumably the 654 patent was not part of the common general knowledge and would not have been discoverable in a reasonably diligent search.”

On further reflection, it seems to me problematic to use double patenting in this situation. Now, it may not matter, if indeed under Hospira the 654 patent is part of the state of the art against the 997 patent. But what if there is a difference? Suppose the 654 patent could not be used in an obviousness attack against the 997 patent, but it could be used in a double patenting attack. In that case, allowing a double patenting attack would mean that the patentee is in a worse position than an unrelated third party. That is, suppose that the 654 patent can be raised against the 997 patent in a double patenting attack, but not in an obviousness attack, and suppose that the 997 patent is obvious over the 654 patent, but not otherwise. That means that the 997 patent would be considered a valid inventive improvement if granted to a third party, but would be invalid if granted to Roche. This seems to me to be contrary to the general principle that validity is objective. It also strikes me as unfair that Roche should be at a disadvantage in patenting improvements to a base technology that it invented and disclosed. 

There is also a problem of consistency with the Act. In Sanofi 2008 SCC 61 [12], the Supreme Court remarked that the law of patents is “wholly statutory.” That is a considerable overstatement: the double patenting doctrine itself, which was approved by the SCC in Whirlpool 2000 SCC 67, is a judicially created doctrine which, in the classic application, prevents an inventor from obtaining a second patent for an invention which is an obvious variant of an invention disclosed in its own unpublished prior application. The doctrine was thought to be necessary precisely because that prior application is not part of the state of the art as statutorily defined in s 28.3. There are many other instances where the courts have supplemented the sparse or ambiguous language of the statute: the non-obviousness requirement, fundamental as it is, was not codified until 1993. But there are limits. As the SCC also pointed out in Sanofi 2008 SCC 61 [12], “the general concepts which are the common currency of patent lawyers are founded on a statutory text, and cannot have any other firm foundation.” If the prior application has already been published, there is no loophole to close.

Now, as noted, none of this matters if, under Hospira the 654 patent could also be raised in an obviousness attack against the 997 patent even if granted to a third party. But that isn’t an adequate reason for holding that the double patenting doctrine applies even if the prior application is published. Hospira postdates the double patenting doctrine, and the two developed independently. If the double patenting doctrine applies now, it would also have applied prior to Hospira, when it did undoubtedly make a difference. Further, Hospira is recent and there is perhaps still some uncertainty as to its scope. Applying the double patenting doctrine in this scenario means that the 997 patent was held to be invalid without ever addressing whether the 654 patent was part of the state of the art against it.

Another problem with using double patenting in this case is that the obviousness-type double patenting was assessed as of the claim date of the 997 patent [153]. That is clearly the appropriate date for an obviousness attack, but it is not clear that it is the correct date for a double patenting attack, as it is currently unsettled whether the appropriate date is the claim date of the first (654) or second (997) patent: see here and here. Now, Manson J has previously held that the appropriate date is the second claim date, and perhaps that is why he used it, but the point is not settled at the FCA level, and it would have been preferable to have this issue discussed expressly.

Since Manson J did not have any discussion at all of whether it was appropriate to use double patenting in this situation, I would presume that Roche simply didn’t object to the use of the double patenting attack and instead chose to focus its efforts on the substantive question of obviousness. Consequently, I would suggest that this decision is not strong authority for the proposition that it is permissible to use obviousness-type double patenting when the first patent is already published.

“[I]t Is Not Obvious That [Windsurfing / Pozzoli] Has Been Useful”

Apotex Inc v Shire LLC 2021 FCA 52 Rennie JA: de Montigny, Gleason JJA affg 2018 FC 637 Fothergill J

            2,527,646 / lisdexamfetamine [LDX] / VYVANSE / NOC

 In Sanofi 2008 SCC 61 [67], the SCC endorsed the four-step Windsurfing / Pozzoli approach to the obviousness determination. In Bristol-Myers 2017 FCA 76 [64] Pelletier JA remarked that “It is true that the Windsurfing / Pozzoli framework does provide structure but it is not obvious that it has been useful.” In this post I will argue that the trouble lies with the Windsurfing / Pozzoli framework itself, which is unhelpful, confusing, wrong and rarely actually applied as it was originally framed.

In Bristol-Myers 2017 FCA 76 [65] Pelletier JA remarked that the obviousness analysis asks “whether the distance between two points in the development of the art” can be bridged by the skilled person. The problem addressed in Bristol-Myers, Ciba 2017 FCA 225 and Vyvanse, has been how to define this “second point.” The second and third steps of the Windsurfing / Pozzoli framework are aimed at defining this second point, and the question is whether it is a helpful way of doing so. I’ll argue that it is not. It works well enough in easy cases—where it is also unnecessary. In the more difficult cases, it is at best an unhelpful distraction and potentially misleading. For the most part, the FC/FCA have used a sound intuition borne of experience to define the end point of the obviousness inquiry, but the courts' success in this respect has been despite the Windsurfing / Pozzoli framework, not because of it.

Focus of the Obviousness Inquiry Should be on the Solution to the Objective Problem

Apotex Inc v Shire LLC 2021 FCA 52 Rennie JA: de Montigny, Gleason JJA affg 2018 FC 637 Fothergill J

            2,527,646 / lisdexamfetamine [LDX] / VYVANSE / NOC

My previous post discussed some puzzles that I see as arising from Vyvanse. In this post I’ll try to address those puzzles. In Bristol-Myers 2017 FCA 76 [65] Pelletier JA remarked that

It may be helpful to keep in mind that the obviousness analysis asks whether the distance between two points in the development of the art can be bridged by the Skilled Person using only the common general knowledge available to such a person. If so, it is obvious. The first of those points is the state of the prior art at the relevant date. References in the jurisprudence to “the inventive concept”, “the solution taught by the patent”, “what is claimed” or simply “the invention” are attempts to define the second point.

While Pelletier JA went on to note that these terms are often treated as being synonymous [66], there is arguably a distinction to be drawn between a focus on the information disclosed in the specification, and the claimed subject-matter. This has given rise to a debate as to whether the proper focus of the obviousness inquiry—the “second point”—is the inventive concept or the claims. The debate has centred on the second and third steps of the Windsurfing / Pozzoli approach to the obviousness determination, endorsed in Sanofi 2008 SCC 61 [67], which seems to distinguish the inventive concept from what is claimed while at the same time treating them as alternative means of defining the second point. In Ciba 2017 FCA 225 Pelletier JA indicated that the claims were the proper focus of the inquiry. In Vyvanse Rennie JA held that it is inventive concept that is the ultimate the end point for the obviousness inquiry [65]. At the same time, Rennie JA indicated that the inventive concept is the same as the “solution taught by the patent,” as that term was used in Bristol-Myers. In this post I will argue that Bristol-Meyers holds the key, though it is somewhat buried. The proper focus of the inquiry is not the inventive concept, nor is it the essential elements of the claim; it is whether the subject-matter defined by the claim is the solution to the objective problem that would have faced the skilled person.

There is certainly a powerful and well-founded intuition that the focus of the inquiry should be on the inventive concept. I’ll start off by making the case in favour of the inventive concept, and then I’ll show where that approach breaks down. My next post will look at where this leaves the Windsurfing test.

A New Framework for Construing the Inventive Concept

Apotex Inc v Shire LLC 2021 FCA 52 Rennie JA: de Montigny, Gleason JJA affg 2018 FC 637 Fothergill J

            2,527,646 / lisdexamfetamine [LDX] / VYVANSE / NOC

In Sanofi 2008 SCC 61 [67], the SCC endorsed the four-step Windsurfing / Pozzoli approach to the obviousness determination. The second step of this inquiry is to “Identify the inventive concept of the claim in question or if that cannot readily be done, construe it.” This initially led to a focus on identifying the inventive concept as a central part of the obviousness analysis. Unfortunately, with no clear test or methodology, identifying the inventive concept has proven to often be difficult, as the FCA noted in Bristol-Myers 2017 FCA 76 (see here). In Ciba 2017 FCA 225 the FCA remarked that the search for the inventive concept can be a “distraction” [76] that has resulted in “confusion” and “uncertainty” that can be reduced “by simply avoiding the inventive concept altogether and pursuing the alternate course of construing the claim” [77]: see here. Consequently, the recent decisions of the FCA “have downplayed the importance of the ‘inventive concept’ as an analytical tool in the context of an obviousness analysis,” and have instead focused the analysis “on the claims themselves”: TearLab 2019 FCA 179 [78]. In Vyvanse the pendulum has swung back towards a renewed emphasis on the inventive concept, with Rennie JA stating that “The inventive concept, properly construed and applied, remains the end point for the obviousness inquiry” [65].

It is not very satisfactory to imagine the jurisprudence of the Court swinging back and forth with the needs of the moment. Bristol-Myers, Ciba, and Vyvanse make sense in their own terms; the more difficult question is how to reconcile them. In this post I will focus on Vyvanse, which is straightforward in some respects but puzzling in others. In the next post I will argue that an approach to obviousness that focuses on the solution to the objective problem faced by the skilled person is the only way to reconcile Bristol-Myers, Ciba and Vyvanse. In a third post, I will argue that the Windsurfing approach is useless or worse and should be abandoned.

No Mosaicing of Obscure Prior Art

dTechs EPM Ltd v British Columbia Hydro and Power Authority 2021 FC 190 Fothergill J

2,549,087 / Electrical Theft Detection System

I had intended to return from my blogging break with a post on the “inventive concept” aspects of Apotex v Shire 2021 FCA 52. That is turning into a bigger project than anticipated. I’ll have a few posts on that issue in another week or two. In the meantime I’ll catch up on the decisions that came out while I was on break, starting with dTechs.

In this decision Fothergill J held dTechs’ 087 patent to be not infringed, and also invalid for anticipation and obviousness. The decision turned almost entirely on claim construction and the facts. There were two legal points of interest, though the decision did not turn on either of them. First, Fothergill J held one of the claim elements to be non-essential. This is not unheard of, but unusual enough to be noteworthy. Of more general interest going forward, while Hospira 2020 FCA 30 held that obscure prior art is now part of the state of the art for the purposes of an obviousness attack, Fothergill J understood it as holding, or at least suggesting, that mosaicing of obscure prior art is not permitted.

The 087 patent relates to a system for detecting the theft of electrical power, such as by illegal marijuana grow-ops. The system works by monitoring the current power consumption at a primary line, that serves a number of downstream transformers, and comparing it to “known consumption patterns” to detect atypical power consumption patterns that might indicate power theft. The inventor and founder of dTechs was a former police officer who had become interested in the identification of marijuana grow operations by tracing the electricity theft during his investigations into organized crime and illegal drugs. He eventually quit the force to set up dTechs and commercialize his invention. The defendants were Awesense, which provided a similar system to BC Hydro, and BC Hydro itself. As usual, the defendants argued non-infringement and invalidity.

Infringement turned entirely on claim construction. Fothergill J adopted a construction of the term “known consumption patterns” that favoured the defendants [153], and non-infringement followed directly [174]. The main point of interest on claim construction was that Fothergill J held a different term, “notifying the utility” to be non-essential, applying the Free World 2000 SCC 66 test for essentiality [154–61]. This is noteworthy because it is quite unusual for a claim term to be held to be non-essential. However, this holding did not make any difference to the result, which turned entirely on the construction of “known consumption patterns.”

In a second point of interest, Fothergill J noted at [248] that in Hospira 2020 FCA 30 [86] the FCA held that all prior art should be considered part of the state of the art for the purpose of an obviousness attack, and not just prior art that would have been discoverable on a reasonably diligent search: see here. It’s convenient to refer to prior art that would have been discoverable on a reasonably diligent search as ‘obscure prior art.’ However, in Hospira “the Federal Court of Appeal acknowledged that the discoverability of a prior art reference may be relevant to the fourth step of the obviousness analysis” [249], in the following passage:

[86] The likelihood that a prior art reference would not have been located by a PSA 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.

In my post on Hospira I noted that “This indicates that there can be no mosaicing of prior art that is not available in a reasonably diligent search.” The point was made somewhat tentatively in Hospira, with the FCA saying that the fact that the prior art is obscure “may” be relevant and that the skilled person “might” not have thought to combine the obscure prior art references. It was not entirely clear whether the FCA was stating a rule of law that mosaicing of obscure prior art is not permitted, or merely suggesting that that would be an issue to be considered on the facts. The “may” and “might” language suggests it is a factual issue, but if so, it is a very hypothetical matter of fact, given that in fact, the skilled person would not have found the obscure prior art as well. It’s a bit convoluted to say that there is a factual issue as to whether the skilled person would have thought to combine two pieces of prior art which she would not in fact have been aware of.

In any event, Fothergill J remarked that “[250] Even if the PSA lacks the ingenuity to combine more than one prior art reference to achieve the claimed invention” the claimed invention would nonetheless be obvious. So, he did apparently understand Hospira to be saying that mosaicing of obscure prior art is not permitted, though his holding that the 087 patent was obvious did not turn on the point.

Fothergill J also held that certain of the asserted claims were anticipated by BC Hydro’s prior practices. While those practices did not reflect the preferred embodiment of the invention, Fothergill J held on the facts that the prior practice would have necessarily infringed and so satisfied the test for anticipation [183], [192], [204]. Most of the asserted claimed were also anticipated by a report prepared by the inventor himself during his time on the police force, which proposed a system that eventually matured into the invention. One key issue on this point was whether the disclosure of the report to the police force was subject to an expectation of confidence. Fothergill J held on the facts that it was not: [209–12], [218]. Most claims were also anticipated by a prior publication, again following on the claim construction holdings and the rule that that which infringes if after anticipates if earlier [219]–[235].

A Selection Patent Does Not Differ in Substance or Form from Other Patents

Apotex Inc v Shire LLC 2021 FCA 52 Rennie JA: de Montigny, Gleason JJA affg 2018 FC 637 Fothergill J

            2,527,646 / lisdexamfetamine [LDX] / VYVANSE / NOC

Rennie JA’s decision for the FCA is noteworthy in three respects. First, Rennie JA held in the clearest of terms that nothing turns on whether a patent is characterized as a selection patent. This is a welcome reaffirmation of prior holdings to much the same effect, but this decision is important because the issue was central to the appeal and the FCA’s holding was so unequivocal. The issue can now be considered settled, as I’ll discuss in this post. Second, Rennie JA provided an extensive discussion of the role of the inventive concept in the obviousness analysis. In many ways this discussion is a helpful clarification of the law, but I must admit that there are some aspects of the decision that make me nervous. I’ll have another post on that issue.

Third, Rennie JA reaffirmed that the various “obvious to try” considerations factors set out in Sanofi 2008 SCC 61 [69]–[70] are factors, not requirements, and they need not all be met [106]–[107[. Normally I would devote a post to this aspect of the decision, but I discussed the issue at length in my very recent post on the decision of Locke JA (Webb, Boivin JJA concurring) in Zytiga 2021 FCA 45, which addressed the point at greater length. The decision of Rennie JA in this case appears to me to be entirely consistent with that in Zytiga, so I won’t blog separately on this aspect of the decision. The important point is that we now have two separate panels of the FCA expressing the same view. In Zytiga Locke JA stated that “I maintain my view that ‘more or less self-evident that it ought to work’ should be treated as a factor in the obviousness to try analysis, and not as a requirement” [36]. This way of putting it suggested that there might be some question as to how widely that view is shared. In light of Rennie JA’s decision in this case, I think this point too can now be considered settled.

As discussed in my post on Fothergill J’s decision, the 646 patent relates to the compound LDX and its use for treating ADHD. Amphetamines have long been used to treat ADHD, but they can be abused by snorting or injection. LDX provides a solution to that problem in the form of an abuse-resistant sustained release prodrug [31]. The main validity attack was based on AU Patent No 54168/65, which disclosed a very large class of related compounds. None of the specific examples disclosed LDX itself, but LDX was included in as one of the many possible configurations in the “advantageous” class described on page 4 of AU 168 [FC 104]. The advantages of LDX as a solution to the problem of amphetamine abuse were not described in AU 168 [FC 108], and the compounds were not even identified as prodrugs [FC 107]. The thrust of AU 168 was that the disclosed compounds might be useful as appetite suppressants that are substantially free of CNS stimulatory activity [FC 106].

There was a question as to whether the 646 patent was a selection patent over AU 168. Fothergill J found it unnecessary to decide this question [29], [FC 98], essentially on the view that nothing turned on that point:

[FC 97] By statute, the basis for assessing anticipation cannot depend on whether the patent is a selection patent or not. The jurisprudence does not imply that anticipation and obviousness in respect of a selection patent are to be assessed over the genus patent from which it is a selection, rather than over the prior art read as a whole. A selection patent “does not in its nature differ from any other patent” (Sanofi-Synthelabo at para 9), there is no reference to selection patents in the Patent Act, and the conditions for a valid selection patent do not constitute an independent basis upon which to attack the validity of a patent. A selection patent, like any other patent, is therefore vulnerable to any attack set out in the Patent Act, but no other.

Apotex argued that this was an error, and that it does matter whether the 646 patent is a selection patent. In particular, Apotex argued that the advantageous properties of a compound over the prior art may only be considered if the patent is a selection patent over that prior art; otherwise, only the bare chemical formula should be considered [19].

Rennie JA firmly rejected this argument. While he did not specifically refer to Fothergill J’s remarks at [FC 97], his holding is very much to the same effect:

[31] There is no magic to the term “selection patent”. . . . The Patent Act does not refer to selection patents and the jurisprudence is clear that a selection patent does not differ in substance or form from other patents.

[32] A selection patent is subject to the same requirements and vulnerable to the same attacks as any other patent, including attacks based on anticipation and obviousness. [T]he failure of a judge to characterize a patent one way or another . . . is not an error of law. Put otherwise, a finding that the characteristics of a selection patent have, or have not, been met, “does not constitute an independent basis upon which to attack the validity of the patent”

[34] As noted, the validity analysis does not change depending on whether the patent was formally classified as a selection patent or not.

[35] There is no divergence between the requirements for a valid patent claim depending on whether it is found in a selection patent or not.

This seems to me to be entirely right.

But there is a loose end. Rennie JA did not directly explain how his holding could be reconciled with the fact that the SCC in Sanofi 2008 SCC 61 [10]–[11] endorsed the three factors set out by Maugham J in IG Farbenindustrie (1930) 47 RPC 289 (Ch). I’ll make an attempt.

The obvious way to reconcile the IG Farbenindustrie factors with the view that there is nothing special about selection patents is to suggest that those factors are simply an alternative articulation of the standard analysis in the specific context of selection patents. This was evidently Rennie JA’s view: “classification contextualizes what specific claims profess to do while also making it easier to compare the facts of the particular case before the Court to other previous fact scenarios” [33].

This was also apparently the view of Maugham J: “I think it would be unwise to endeavour to state in definite language all the conditions on which a selection patent must depend; for after all a selection patent does not in its nature differ from any other patent and is open to attack on the usual grounds of want of subject-matter, want of utility, want of novelty and so forth” (322)’ the same view was also suggested in Sanofi [9], quoting part of this passage.

With that in mind, consider the factors themselves, as set out in Sanofi [10]:

1. There must be a substantial advantage to be secured or disadvantage to be avoided by the use of the selected members.

While the tripartite IG Farbenindustrie test was often referred to, this first factor was undoubtedly the most important, as it was the factor that was normally actually applied (along with Maugham J’s statement at 321, which is not part of the tripartite test as such, that “the selected compounds have not been made before, or the patent would fail for want of novelty.”) It is therefore fortunate that this factor is easy to reconcile with a standard analysis. It was explicit in both IG Farbenindustrie and Sanofi that this is a reflection of the inventive step requirement: “If the selected compounds. . . possess a special property of unexpected character. . . I cannot see that the inventive step essentially differs from the step involved in producing a new result by a new combination of well-known parts . . . in mechanics in the construction of a new machine” (321), quoted in part in Sanofi [9]; “if for practical purposes it is not obvious to skilled chemists in the state of chemical knowledge existing at the date of a selection patent that the selected components possess a special property, there is then, or at least there may be, a sufficient ‘inventive step’ to support the Patent” (322). The idea is that if the originating patent disclosed a large class of compounds and disclosed that they are all, eg antipsychotics with moderate to severe side-effects, there is nothing inventive in pulling one at random out of the class and establishing that it is an antipsychotic with moderate to severe side-effects. An arbitrary selection is not inventive.

The second factor is as follows:

2. The whole of the selected members . . . possess the advantage in question.

This is trickier. Maugham J stated that if this is not satisfied, “the patent would be misleading and would also fail for insufficiency and non-utility.” Unfortunately, Maugham J did not provide any further details, and it is not immediately clear how the patent would fail in light of English patent law of the day. In modern Canadian law, “misleading” patents are dealt with under s 53, which now has a well-developed body of jurisprudence. To the extent that the second factor was intended to address such problems, it must considered to be displaced by the statutory provision of the Canadian Act. I have to admit it is not clear to me why the patent would be insufficient; a failure of the second factor would not affect the classic “how to make” enablement. There are other aspects of the English sufficiency law of the day which Maugham J might have had in mind, eg ambiguity. The law of utility has also developed considerably since 1930, and arguably if the genus claim in the originating patent was valid, all the claimed compounds which it encompassed must have been useful, and it is hard to see how they would become less useful simply because some other compounds are more useful.

With all that said, it is clear that Maugham J considered his second factor to be nothing more than the application of general principles to the context of selection patents. To the extent that modern Canadian law has diverged from century old English law, then it seems plain that our modern law should govern; it would be wrong to regress—or worse, displace statutory provisions—by adhering to a test for selection patents that was based on century old English law.

On to the third factor:

3. The selection must be in respect of a quality of a special character peculiar to the selected group.

Maugham J at 323 indicated that this was not based on established principles, but was rather his own analysis. It not clear whether this was ever good law. I am not aware of any case which has actually applied this factor to hold a patent invalid. Moreover, this factor was also criticized on substantive grounds by the EWCA in Dr Reddy’s [2009] EWCA Civ 1362 [39], which also held that the whole IG Farbenindustrie test was no longer part of English law.

None of this conflicts with the SCC holding in Sanofi. The only one of the three factors actually applied was the first—see eg [31], [31], [41]— which, as discussed above, is clearly based on the standard non-obviousness requirement. Moreover, while the SCC in Sanofi certainly spoke favourably of Maugham J’s analysis, the Court did not go so far as to say that the tripartite test had to be satisfied as a matter of law. Rather, the SCC stated that it is “a useful starting point for the analysis to be conducted in this case.” [11]. Experience has shown that it is not a particularly useful starting point in most other cases. It is not contrary to Sanofi to recognize that fact.