Is a Patent Insufficient If it Requires a Minor Research Project to Practice?

Takeda Canada Inc v Apotex Inc 2024 FC 106 Furlanetto J

2,570,916 / dexlansoprazole / DEXILANT / NOC

As discussed in my last post, the patent at issue in this case related to a “pulsatile” dosage form of proton pump inhibitors (PPIs) comprising a PPI with “a first and a second dose,” which are released from the dosage form as “discrete pulses,” resulting in specified blood plasma concentrations [90], [92]. Takeda’s DEXILANT product is a pulsatile release formulation of the claimed type, which includes two types of delayed-release beads containing dexlansoprazole [6]. Apotex sought to sell a dexlansoprazole oral dose capsule product and Takeda brought this NOC action in response [2]. As discussed in my last post, Furlanetto J held that Takeda had not established infringement. That aspect of her decision was entirely straightforward, and would have been sufficient to dismiss the action [148]. Furlanetto J nonetheless went on to address Apotex’s validity arguments, “which formed a significant portion of the parties’ arguments at trial” [148]. The last post discussed the novelty argument. This post deals with the remaining validity issues. It raises the thorny issue of whether the factual basis for a sound prediction must be disclosed in the patent; I review the debate, though in the end this decision adds nothing new, as the point was not contested. The other interesting issue is the treatment of sufficiency, which strikes me as problematic in apparently requiring a patentee to disclose in the patent the amount of active ingredient necessary for clinical efficacy.

Obviousness

There is nothing notable in the obviousness analysis, but a brief description is useful in understanding the utility argument. While pulsatile dosage forms were known in the prior art for dealing with the breakthrough effect, there were some differences between the prior art and the asserted claims: in particular, the asserted claims specified the plasma concentrations needed to prevent breakthrough [209] and also required the second dose to be larger, to compensate for reduced absorption in the lower digestive tract [213]–[215]. Furlanetto J held that these differences would not have been obvious, in an analysis that turned on the facts [217]–[227].

Utility

Furlanetto J stated that “where the utility is founded on a sound prediction, the factual basis for the prediction must be set out in the patent disclosure” to the extent it is not based on the CGK [231]. Whether the factual basis for a sound prediction needs to be disclosed in the patent is a long running debate seeming from an enigmatic statement in Wellcome / AZT 2002 SCC 77 [70]:

Thirdly, there must be proper disclosure. Normally, it is sufficient if the specification provides a full, clear and exact description of the nature of the invention and the manner in which it can be practised. . . . In this sort of case, however, the sound prediction is to some extent the quid pro quo the applicant offers in exchange for the patent monopoly. Precise disclosure requirements in this regard do not arise for decision in this case because both the underlying facts (the test data) and the line of reasoning (the chain terminator effect) were in fact disclosed, and disclosure in this respect did not become an issue between the parties. I therefore say no more about it.

The Federal Courts initially understood this as requiring only the standard disclosure of how to make and use the invention: see eg Aventis Pharma v Apotex 2006 FCA 64 [28]–[35] affg 2005 FC 1283 [178]–[254]. Then, in Raloxifene 2008 FC 142 [164] affd 2009 FCA 97 [15], Hughes J interpreted this paragraph of Wellcome / AZT as requiring disclosure of the factual basis for the sound prediction in the patent itself. (There’s also a separate issue as to what is meant by “this sort of case”: see AstraZeneca FC 2014 FC 638 [141], discussed here.)

There are two main problems with this. First, the factual basis for sound prediction was not disclosed in the patent in the leading cases: see my post “The underlying facts were NOT in fact disclosed,” showing that the factual basis for the sound prediction was not disclosed in Wellcome / AZT itself; and see my comments to that post showing that the factual basis was not disclosed in Olin Mathieson [1970] RPC 157 (Ch) either, which Wellcome / AZT [60] identified as the case which gave “serious shape and substance” to the doctrine. Second, it seems clear that there is no duty to disclose the factual basis for demonstrated utility in the patent. (Initially it was entirely clear that there was no such duty, but after the enhanced disclosure requirement was advanced for sound prediction, there have been some hints that there is an enhanced disclosure requirements for demonstrated utility as well.) There is only one utility requirement in the Act, and it is often a very fine line between demonstrated utility and sound prediction — the difference will turn on exactly how much data has been collected. So, if the facts A, B, C and D are enough to demonstrate utility, but the facts A, B & C are only enough to establish a sound prediction, if the applicant is in possession of the facts A, B, C and D, it will not need to disclose any of them, but if the applicant is only in possession of the facts the facts A, B & C, they will need to be disclosed. It is difficult to see any rationale for this distinction. The only rationale that has been provided for the heightened disclosure requirement for sound prediction is the statement in Wellcome / AZT [70] that “the sound prediction is to some extent the quid pro quo the applicant offers in exchange for the patent monopoly.” This statement is completely opaque, which is entirely understandable, given that it was expressly obiter. As a result, it is not clear what the rationale is for a heightened disclosure requirement for sound prediction; and it is double unclear as to what the rationale might be for distinguishing the disclosure requirement in a case of sound prediction from that when utility is demonstrated.

In this case, the parties evidently accepted that the factual basis must be disclosed in the patent, as Furlanetto J did not indicate that her statement at [231] was disputed. I’m not convinced that the the point is settled. Furlanetto J relied on Eurocopter 2013 FCA 219 [153], Apotex v Allergan 2015 FCA 137 [9] and Pharmascience v Teva 2022 FCA 2 [5]. Eurocoper says only that disclousre of the factual basis “may” be required and Apotex v Allergan merely paraphrased this in a brief decision affirming the decision below on the facts. Pharmascience v Teva 2022 FCA 2 is more directly on point, but even there Locke JA’s remarks are ambiguous, as discussed here. Since the parties did not dispute the point, this decision doesn’t add any authority to the debate. The issue will eventually have to be clarified by the FCA.

Given that position, the question was whether two examples provided a sufficient factual basis for a sound prediction of utility. The parties agreed that the requisite utility was simply “to give a pharmacological effect (i.e., as agreed by the parties in this context, an effect on gastric acid pH)” [233]. Furlanetto J found that a scintilla of utility had not been established on the facts [248], apparently because “the effect of a pulsatile release dosage form on gastric pH could not have been predicted” [244].

I have to admit, I find this very suprising. It is very well known that PPIs are effective in treating GI issues, at least when given in a large enough dose to meet threshold blood plasma levels. Claim 11, which was one of the assserted claims [2], specifies blood plasma levels of at least 450 ng/ml, which I take it is well over the threshold. Presumably if this concentration were achieved with a single dose, it would be effective. I find it very difficult to understand how it makes any difference if the same plasma level is achieved with pulsatile dose. But I have to admit that I couldn’t really follow the technical evidence reviewed by Furlanetto J, and anyway, it is a finding on the evidence.

Sufficiency

Furlanetto J held the disclosure was insufficient for two reasons.

[258] First, Example 1 does not provide sufficient information for the PSA to understand how the inventors arrived at the oral dosage data and steady state plasma concentrations in the patent. As highlighted earlier and explained by Dr. Davies, the experimentation said to underlie Example 1 yielded modelled results that would be known to the PSA to be significantly lower than actual steady state plasma concentration values. Further, the data was from an IV study alone at one time point and did not include the subsequent oral dosage modelling data that was necessary for the inventors to translate the results of the modelling to threshold concentrations for a pulsatile release oral dosage form to be used over a 24 hour time period.

I find this passage a bit difficult to understand. The second sentence suggests that the problem is that the data is misleading. If that is the issue, Takeda was right in saying that this was a disguised s 53 attack [260]. Alternatively, Furlanetto J might be saying that the defect was simply the failure to disclosure how the inventors “arrived at the oral dosage data and steady state plasma concentrations.” This seems to be saying that the inventors must disclose in the patent the experiments and reasoning process that led them to arrive at their invention. If that is what was meant, it is not correct. As it happens, this point was addressed by Manson J in his very recent decision in Proslide v WhiteWater 2024 FC 175, in which WhiteWater argued that “the key principle” of the law of sufficiency is that “information known by the patentee may be considered in assessing whether the disclosure is sufficient,” and that “[f]acts known by the inventor, and intentionally omitted or not communicated in the description of a patent can result in disclosure being insufficient”. Manson J rejected this argument, encapsulating the established law of sufficiency as follows:

[19] WhiteWater’s position broadens the scope of sufficient disclosure beyond what the law actually supports. Section 27(3) of the Patent Act, RSC, 1985, c P-4, requires the patent to make a full disclosure, but that requirement pertains to “the invention and its operation or use as contemplated by the inventor” in the patent. Therefore, the extent of the obligation to make sufficient disclosure is limited in two ways. First, the information need only pertain to the invention as disclosed and claimed by the patent. Second, that information must enable the skilled person to make or use that invention (Teva at paras 50-52, 70). Further disclosure is not necessary to meet the requirements of sufficiency as contemplated by section 27(3).

On the whole, I suspect that what Furlanetto J was really getting at in this paragraph was similar to her second point, which is easier to understand, so I’ll turn to that.

The second point turned on the fact that the patent claims a dosage form containing an amount of PPI that results in a specified plasma concentration, but it does not disclose the amount of the PPI that is required to achieve that concentration. The amount of PPI required to achieve the specified plasma levels would depend on a variety of factors, such as the exact dosage form, as the excipients can affect absorption [263]–[264]. Consequently, determining the exact amount of PPI to achieve the specified levels would require a non-trivial amount of routine research, albeit not rising to the level of invention.

Furlanetto J cited Idenix v Gilead 2017 FCA 161 [19] for the proposition that “[a] disclosure is insufficient if it necessitates the working out of a problem,” and Seedlings 2021 FCA 154 [68], Leo Pharma 2017 FCA 50 [59] and Teva 2012 SCC 60 [75] for the proposition that “a minor research project is too much,” though some non-inventive trial and error experimentation may be permitted [257]. Applying this threshold to the facts, she held on the facts that the effort requires was too much [268].

This is problematic. Novel drugs are often patented very early in the R&D process, often on the basis of in vitro tests only, at a point where identifying the actual dose and dosage form necessary for clinical efficacy is a very long way off. This is typically true when utility is based on a sound prediction, and is often true even when utility has been demonstrated. While the patent will typically state the quantity needed, this is normally little more than guesswork. For example, in ZYTIGA 2021 FCA 45, concerning the 2,661,422 patent, which related to a combination of abiraterone acetate & prednisone for treating prostate cancer (discussed here), the specification stated that the amount to be administered was “about 0.01 mg/kg/day to about 100 mg/kg/day of abiraterone acetate” — a range of four orders of magnitude, and that for a compound that was already known. Similarly, in Rosiglitazone 2011 FC 239 (discussed here), the specification stated that the unit dose “normally contain an amount of the active ingredient in the range of from 0.1 to 1000 mg.” In HGS v Lilly [2011] UKSC 51, concerning EP(UK)0,939,804, relating to neutrokine alpha and related anitbodies, the specification stated that “[0125] As a general proposition, the total pharmaceutically effective amount of Neutrokine-α polypeptide administered parenterally per dose will be in the range of about 1 µg/kg/day to 10 mg/kg/day of patient body weight, although, as noted above, this will be subject to therapeutic discretion.”

It might be suggested that this case is different because the claims specified the requisite blood plasma concentration of the active ingredient and determining this concentration was part of the inventive concept. But sufficiency requires that the patentee disclose how to use the invention. Even when the plasma concentration is not specified, the skilled person still has to be able to practice the invention by determining an effective amount of the drug, so this doesn’t seem to be a difference in principle. A patent is sufficient if some trial and error is needed to find the clinically effective dose when a new compound is claimed, and the trial and error needed to find the dose needed to find the plasma concentration in this cases seems to be of the same nature, and if anything less extensive, given that the desired concentration is specified. But maybe there is more to this point that I am not seeing.

In coming to her conclusion, Furlanetto J relied primarily on the SCC Teva decision [267], which invalidated the patent for requiring what the decision repeatedly referred to as a “minor research project.” More specifically, and crucially, in Teva the skilled person would have to “undertake a minor research project to determine what the true invention was” [75] (my emphasis). This reference to determining the “true invention” was repeated consistently, in all the SCC’s references to a “minor research project”: see [17], [74], [75]. The issue in Teva was that the patent disclosed that one of the especially preferred compounds had been tested in humans and found to be effective, but the patent did not disclose which one. It was the failure to disclose which compound had been tested that constituted the failure to disclose “the true invention.” As the SCC noted in Teva, the trial judge felt that requiring the skilled person to undertake “a minor research project in order to determine which of the claims describes the true invention. . . plays games with the reader.” And as the FCA noted in Leo Pharma, the issue in Teva was that “the patentee had deliberately omitted essential information, thereby obscuring the fact that only one of the compounds claimed actually worked. Thus, the invention itself was not even properly disclosed” [58]. (See also Proslide [26], to the same effect.)

Thus the disclosure requirement at issue in Teva was not about disclosure of how to make the invention, it was disclosure of “the true invention.” And as the FCA pointed out in BRP v Arctic Cat 2018 FCA 172 [78], “[e]nablement (how to practice the invention) is a concept completely distinct from the disclosure of the invention itself, the latter of which was at issue in [Teva].” In this case there was no suggestion that Takeda had tried to conceal the true invention. The disclosure requirement at issue in this case was not disclosure of the true invention, but standard enablement, or how to practice the invention. And as the FCA further pointed out in Leo Pharma [58]–[59] and in BRP v Arctic Cat [78], the SCC in Teva did not change the traditional standard for sufficiency of disclosure of how to make the invention. In BRP v Arctic Cat [78], the FCA held that it was an error of law to apply the Teva standard for disclosure of the invention to the completely distinct context of enablement. With respect, it appears that Furlanetto J may have made that error in this case.

With all that said, I would return to the s 53 point. If Takeda actually knew the amount of active ingredient necessary to achieve the specified plasma concentrations and failed to disclose it, it is possible that there might be some kind of wilful misleading argument to be made. I don’t want to explore this further since it wasn’t at issue; the point is simply that a s 53 objection should be dealt with under s 53, and not by a strained interpretation of the sufficiency requirement.

Claims Broader

Apotex argued that the claims were overbroad “because the work of the inventors established that at least 1 hour was required between the pulsed doses; however, this 1 hour was not claimed” [270]. This seems to be redundant with utility, but in any event, it failed on the facts [274].

Ambiguity

A weak ambiguity attack also failed on the facts: [275]–[279].

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.

Sufficiency, Overbreadth, or Utility?

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

2,226,784 / tadalafil / CIALIS / NOC

I’m back to blogging again after an end of term vacation—still catching up on the backlog from my longer hiatus over the winter. In my last post on this case I discussed the meaning of “or”. This post turns to validity. St-Louis J held the 784 patent to be invalid for overbreadth [120] and insufficiency [149], while declining to address utility. I have argued that overbreadth is almost always functionally duplicative of another established ground of invalidity, and this case illustrates that point once again, as the facts supporting the finding of overbreadth were the same as those supporting insufficiency.

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

St-Louis J found on the facts that it is not possible to make a physiologically acceptable salt of tadalafil [118]. Tadalafil does not have an ionisable functional group and consequently it is very difficult to make a salt form [103]. It may be possible to make one or two salts, but only under extreme conditions that would result in the degradation of the tadalafil such that the resultant salt would not be sufficiently pure and stable to be considered physiologically acceptable [118]. As a result, St-Louis J held the 784 patent to be invalid for overbreadth [120] and insufficiency [149], while declining to address utility.

As discussed in my last post, St-Louis J concluded that a physiologically acceptable salt is an essential element of the claim. While I have my doubts about that conclusion, once we accept that, the claim is effectively to a physiologically acceptable salt of tadalafil, and insufficiency then follows directly from the fact that it is not possible to make even one physiologically acceptable salt. This is the classic “how to make” variety of sufficiency. If you claim “Compound X” you have to tell a skilled person how to make Compound X, or the claim is invalid for insufficiency. The traditional view is that the purpose of the disclosure is to ensure that the public would have benefit of the invention after the term expired: see eg Minerals Separation [1947] ExCR 306, 316. If a skilled person cannot make the claimed compound with the guidance provided by the specification, the patentee could get the benefit of patent protection during the term, while keeping its monopoly through secrecy after the term expired. There is an extremely difficult question as to whether the invention has to be enabled across the full scope of the claim. But that doesn’t concern us here, as the specification did not provide sufficient instruction to allow a skilled person to make any physiologically acceptable salt.

A standard statement of the sufficiency requirement is that the specification must enable the skilled person to practice “the invention” [133]; citing s 27(3) and Teva 2012 SCC 60 [51]. But what is “the invention”? That term is notoriously ambiguous: “The word ‘invention’ has many meanings and nuances,” as Henderson pointed out in Patent Law of Canada (1994) 7–8. It can mean the inventive concept, which is to say the information disclosed in the patent which is the quid pro quo for the grant; it can means the invention as claimed, which is the set of all existing or future embodiments of the claimed invention; or it can mean a particular embodiment: see British United Shoe Machinery Co Ltd v A Fussell & Sons Ltd (1908) 25 RPC 631 (CA) 649–51. This led to a debate in this case in which Lilly argued that insufficiency was not available as an attack because the Defendants had not established the nature of the invention [139]. Lilly’s argument isn’t fleshed out in enough in St-Louis J’s decision for me to fully understand it, but I suspect the point is that the inventive concept was the discovery that tadalafil is an effective treatment for ED, and not the discovery of how to make a salt form of a compound that was already known to be effective. If that is indeed what Lilly was arguing, it is effectively another angle on the “or” argument, and one which, in my view, is better framed in terms of claim construction (as discussed in my last post) rather than sufficiency. So, given St-Louis J’s conclusion on the meaning of “or”, I would say she was right to reject Lilly’s argument on this point [143], to focus on whether the specification instructed how to make the salt [144]–[148]. And since the answer to that on the facts is “no,” I agree with her conclusion that the patent is invalid for insufficiency [149] (given her conclusion on the construction of “or”).

With all that said, the ambiguity as to the meaning of “the invention” made this part of the decision more convoluted that it needed to be. Given the ambiguity of the phrase “the invention,” I suggest it might be desirable for the courts to simply stop using it altogether, in any context in which precision is necessary—which is to say, especially in defining validity doctrine. Instead, the law should specify “the invention as claimed” or “an embodiment of the invention,” or “the inventive concept,” as appropriate to the particular doctrine. That is a clarification that would probably have to be done by the FCA, since many authoritative statements of the law use the ambiguous term “invention.”

On that note, I would also point out that the law of sufficient disclosure has several threads that need to be disentangled, and the meaning of “the invention” isn’t necessarily the same for each aspect of the disclosure requirement. The SCC in Consolboard [1981] 1 SCR 504, 518, noted that the statutory provision, s 27(3) “gives the impression of a mélange of ideas gathered at random rather than an attempt to enunciate, clearly and concisely, a governing principle or principles.” While the Court in Consolboard at 518 suggested that the haphazard nature of the statutory provision might be the product of amendment over a period of many years, I think the truth is that the case law gives a similar impression of a mélange of ideas. This is illustrated by Thorson P’s well-known summary of the disclosure requirement established by the case law in Minerals Separation [1947] ExCR 306, 316–17. I won’t repeat it here, but it is plain on its face that it runs together several concepts that are sometimes only tangentially related.

Moving on, St-Louis J also held the asserted claims to be invalid for overbreadth:

[120] As I conclude that it is more probable than not that physiologically acceptable salts of tadalafil cannot be made I conclude, as the Defendants argue, that such a salt was not invented. The Asserted Claims therefore claim broader than what was invented and are thus invalid for overbreadth.

In my article Overbreadth in Canadian Patent Law: Part I (2020) 33 IPJ 21 and Part II (2021) 33 IPJ 147, I argued that a finding of invalidity for overbreath is almost always redundant with another established ground of invalidity. And so it is here. All the evidence St-Louis J reviewed in the context of overbreadth went to the question of whether went to whether a physiologically acceptable salt could be made [114]–[119]. Exactly the same facts that results in a finding of insufficiency—that the claim compound could not be made—was also the basis for the finding of overbreadth.

The problem with overbreadth is that it remains ill-defined. St-Louis J noted that “There are two (2) ways that a patent claim can fail for overbreadth (or overclaiming): it can be broader than the invention disclosed in the specification, or it can be broader than the invention made by the inventor” [109]. It seems that in this case she was relying on the second prong, as she noted that

Under the claims broader than invention made, it is a question of fact as to what the inventor actually invented [112].

But what does “actually invented” mean? As I argued in my Overbreadth article, if the patentee has sufficiency disclosed and claimed subject-matter that is new, useful and non-obvious, how could it be said that they had not “invented” the claimed subject-matter? Overbreadth has an air of being something distinct only because of the ambiguity in the phrase “the invention.” It sound very reasonable to say that the patentee cannot claim more than it invented, but if we try to define exactly what is meant by “invention,” it is difficult to give this proposition any content that is independent of the standard grounds of invalidity.

In any event, as noted, this is another case in which overbreadth is redundant as turning on the same analysis as another ground of invalidity, in this case insufficiency.

The third issue is as to utility. The utility argument turned entirely on the point that a physiologically acceptable salt could not be made: the Defendants argued that “the failure of the 784 Patent to indicate which of the many possible salts can be made as a physiologically acceptable salt of tadalafil” renders the asserted claims invalid for a lack of utility [154], while Lilly argued that “the Defendants have not met their burden to establish that a physiologically acceptable salt of tadalafil cannot be made” [159]. That is, the argument was that the invention lacked utility because a physiologically acceptable salt could not be made; it really just recapitulated the sufficiency argument. To my mind, this conflates utility and sufficiency. (This is not a criticism of St-Louis J, as this is the way the case was argued.) I have to admit, this conflation is very common. There was really no distinction between the two in early English practice, before the development of claims; if the specification describes a device that is not operable, there is no distinction to be made between a case where the patentee had devised a useful invention but failed to disclose it and a case where the specification disclosed the invention precisely, and the invention itself was useless, unless recourse is had to extrinsic evidence.

But with the advent of claims, we can distinguish between the two. The utility requirement asks whether the claimed invention works (or can be soundly predicted to work). Sufficiency asks whether the claimed invention can be made. These are different. Suppose, for example, that in the early days of genetic engineering, the patentee claims “Pure human insulin.” The claimed subject-matter, pure human insulin, is undoubtedly very useful. If the patentee cannot actually make it, the patent is invalid for insufficiency, but not for lack of utility. On the other hand, it may be easy to make something that lacks utility. If the patent claims “Oregano oil for the treatment of cancer,” the claim is sufficient, because oregano oil can be made and administered with the intent of treating cancer, but invalid for lack of utility because oregano oil does not in fact treat cancer. Applications for impossible inventions, like a perpetual motion machine, are traditionally rejected for both lack of utility and insufficiency; in my view, they should be rejected for insufficiency alone. After all, a device with greater power output than input would be extraordinarily useful—if it is could be built. With all that said, I acknowledge that there is a lot of confusion in the caselaw on this issue, stemming ultimately, in my view, from the fact that the distinction could not be drawn prior to the introduction of claims.

Ultimately, St-Louis J, wisely, in my view, declined to address the utility argument. The Defendants argued that”a claim must fail if, in addition to claiming something that is useful, it also claims something that is useless” [173]. In other words, the question is whether utility has to be established across the full scope of the claim. St-Louis J reviewed the caselaw and noted the uncertainty on the question of whether a claim is invalid if it claims a single inoperable species [175]–[178]. Given that she had already held the asserted claims invalid on two other grounds, she refrained from deciding this point of law, and so she declined to rule on the utility ground [178]. This is a difficult question, which is better left to a case in which it is the focus of the argument.

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.

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.

“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.

Enabling After-Arising Technology

Pfizer Canada ULC v Seedlings Life Science Ventures, LLC 2021 FCA 154 Locke JA: Gleason, Laskin JJA affg 2020 FC 1 Grammond J

2,486,935 / FC accounting / FC reasonable royalty / FC novelty and utility / FC claim construction / FC Overbreadth

The Seedlings decision is notable for holding that overbreadth is an independent ground of invalidity, but the discussions of insufficiency and entitlement to an accounting are also of interest. In this post, I’ll start with the insufficiency issue, which raises the very difficult issue of how the enablement requirement applies to after-arising technology. The post is long, but the bottom line is that the key holding, that “[t]he disclosure must teach the skilled person to put into practice all embodiments of the invention, and without exercising inventive ingenuity or undue experimentation” [68] This must be wrong, or any invention that is capable of improvement would be invalid for insufficiency. But this means that on its face, Seedlings raises some very obvious avenues of attack on almost any patent, particularly those relating to mechanical inventions. I suspect these attacks will mostly fail—unsurprisingly, there is a very large body of caselaw to the effect that a patent is not invalid simply because it encompasses improvements. Unfortunately, I don’t see a lot of wiggle room for a principled distinction on the facts. So the interesting question will be how the FCA will handle Seedlings going forward and how much the law will ultimately change as a result.

The invention at issue relates to an auto-injector, primarily intended for injecting epinephrine to treat anaphylaxis. The best known auto-injector is the EpiPen. The original EpiPen was relatively bulky—a cylinder about 15 cm long and 2.5 cm in diameter—which made it inconvenient to carry. Another problem was that the needle remained exposed after use, which is a particular concern in light of the risk of transmission of blood-borne diseases [FC 11]–[12]. The patented injector device solved these problems. It is flat and much smaller than the original EpiPen—the size of a thick credit card—so it is more easily carried and used [FC 63]; and it has an actuator that moves forward once the injection is complete to serve as a shield that protects the needle [FC 19]: see the video here. This second aspect of the invention, which I’ll refer to simply as the needle shield, is at the center of the holding on both insufficiency and overbreadth.

A number of claims were asserted, but the claims of particular interest are claims 40, 59, 60 and 62. Claim 40, which is representative of the claims of interest, “describes an auto-injector with a flat housing, that is front-actuated and that has an actuator that also serves as a needle shield. That is the ‘inventive concept’ of this claim” [FC 139]. These claims were invalidated by Grammond J solely on the ground of overbreadth. The FCA affirmed on overbreadth [56]–[65], but held that the claims were also invalid for insufficiency [66]–[72], reversing Grammond J [185]–[186] on that point. The claims were neither obvious nor anticipated ([FC 102], [FC 115], [FC 138] affd [40]–[45]), nor did they lack utility [FC 163]. Grammond J held that none of the asserted claims were infringed by Pfizer’s Next Generation Auto-Injector (NGA) Epipen, which is oval in cross-section, not flat [191], [208]. The FCA did not address infringement in light of its conclusion that the claims were invalid [74]. Consequently, the FCA holding on validity is not obiter, even in a technical sense.

Skepticism Regarding I G Farbenindustrie Test for Selection Patents

Bristol-Myers Squibb Canada Co v Pharmascience Inc 2021 FC 1 Zinn J

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

This decision consolidated four actions concerning the 202 patent, which claims the compound apixaban and its use in treating thromboembolic disorder, including stroke [2], [27], and the 171 patent, which claims various formulations of apixaban[2], [114]. The decision raises several legal issues, though largely as a result of some “creative” submissions by the defendants [125]. The most important point is that Zinn J expressed considerable skepticism regarding the continued vitality of the I G Farbenindustrie test for selection patents. Zinn J addressed the 202 patent first and then the 171 patent. I won’t cover every issue, but only those that caught my eye.

Date for assessing sufficiency

The first attack on the 202 patent was based on insufficiency. There was some discussion of whether the date for assessing sufficiency is the date of filing or the date of publication [36]–[42]. I’ll note that there has indeed been some debate in the case law on this issue, but the point was settled in Idenix v Gilead 2017 FCA 161 [46], holding that the correct date is the filing date, in a case that was crucial to the result. (I’d suggest that while Idenix ruled out the publication date, there remains an open question as to whether it should be the claim or the filing date, as that distinction was not at issue in Idenix—I’d argue that it should be the claim date, but that’s for another day.) Idenix was not cited by Zinn J, presumably because it was not cited to him, and consequently he appears to have considered the publication date to be the relevant date [49].

In any event, so far as I can tell, nothing turned on this point. As both filed and published the application claimed 10¹⁰⁰ compounds, and it was only just before issuance that the claims were narrowed to one compound, namely apixaban [37]. The defendants apparently argued the patent was insufficient because it did not enable all 10¹⁰⁰ compounds to be made [37]. That is, sufficiency had to be assessed in terms of the document as it existed at the relevant date (whatever that date might be). That is certainly a very creative argument, but. . . no, “The test for sufficiency is whether [the skilled person] is in a position to work the invention. The invention is that claimed in the patent, and until it is issued, there is no patent” [49]. That must be right — if it weren’t almost every granted patent would be invalid, because claims are routinely amended during prosecution in response to objections by the examiner, which necessarily takes place after filing. If anticipation, utility and obviousness all had to be assessed as of the claim date or filing date, then amendments to the claims could never cure any objection.

Studies demonstrating utility need not be referenced in the patent

The defendants also argued that the patent was invalid for lack of utility because the study demonstrating utility must be referenced in the patent. Zinn J rejected this proposition, relying primarily on statements by the SCC in Sildenafil 2012 SCC 60 [39]–[40] and AstraZeneca 2017 SCC 36 [58]. I’ll add that Gleason J (as she then was) reviewed the authorities in Lilly v Apotex 2015 FC 1016 [138]–[141]. She pointed out that the FCA authorities supporting such a requirement were obiter, and there are many cases to the contrary, and she therefore concluding that “the weight of authority is to the effect that the evidence of demonstrated utility need not be referenced in the patent for the patentee to rely on it” [142]. I think this point can now be considered settled, though it would certainly be desirable to have it addressed by the FCA to remove any lingering doubt.

A genus too large to think about does not anticipate

The most interesting issue was an anticipation attack based on 2,349,330, which disclosed and claimed a large class of compounds that were potentially useful in the treatment and prevention of thromboembolic disorders [79]. The class is very large. One of the experts for Sandoz did a calculation of the number of compounds disclosed and came up with “Some number that is just larger than I can think about.” He agreed that it was “more possibilities than stars in the universe” [80]. On the evidence provided by Sandoz’s experts, the class encompassed apixaban [77], but did not specifically disclose it, or describe how to make it [82]. On this evidence, Zinn J had no difficulty in concluding that the 330 patent did not anticipate apixaban [83].

Nor was apixaban obvious over the 330 patent, as only a small percentage of the disclosed compounds would actually be effective in treating thromboembolic disorders, and identifying which would involve “complex, time-consuming, unpredictable research” [87]. Obviousness-type double patenting failed for the same reason: [96]–[97].

IG Farbenindustrie test doubted

Apixaban is therefore a classic selection over the 330 patent. Significantly, it was only after finding that apixaban was neither anticipated nor obvious over the 330 patent that Zinn J turned to question of selection patents as such and the three-part test set out in IG Farbenindustrie (1930), 47 RPC 289 (Ch) 322-23, that was approved in Sanofi 2008 SCC 61 [9]-[11]. The factors, in summary, are: (1) a valid selection must possess some substantive advantage over the genus; (2) all of the selected members must possess the advantage; (3) the advantage must be peculiar to the selected group. Zinn J held that these three propositions are “not a stand-alone basis to find a selection patent invalid,” relying on the express holding to that effect in Olanzapine 2010 FCA 197 [33] where the FCA stated that an assessment of whether the IG Farbenindustrie conditions has been met “does not constitute an independent basis upon which to attack the validity of a patent” [104]. Despite this holding by the FCA, the IG Farbenindustrie conditions continue to resurface as an independent ground of attack, most recently in Lilly v Mylan 2020 FC 816, discussed here.

Zinn J’s contribution to this debate was to go back and quote from the explanation for these factors given by Maugham J in IG Farbenindustrie itself [100]. In the passage quoted by Zinn J, Maugham J specifically connected the first and second factors to standard grounds of attack, namely utility and insufficiency. The explanation given by Maugham J for the third factor is somewhat more obscure, and also more controversial, as it was specifically criticized in Dr Reddy’s [2009] EWCA Civ 1362 [39]. I suspect that the third factor was an imperfect attempt to avoid the problem of arbitrary selection, which is properly treated as an aspect of non-obviousness. I might also add that I am not at all convinced that the first and second factors are properly related to utility, as Maugham J indicated. But the important point here is that Maugham J did explain the factors he set out in terms of the traditional grounds of invalidity. As I read it, Maugham J considered these factors to be a helpful way of stating the standard principles in the context of a selection patent, and not as an entirely new ground of attack. I agree therefore, with Zinn J’s observation that for Maugham J, and for Rothstein J in Sanofi referencing Maugham J’s analysis, “a failure to meet his three propositions regarding selection patents does not invalidate the patent; rather its validity is subject to the usual grounds relevant to any patent” [101]. I am very pleased to note that Zinn J also cited my blog post, Time to Relegate IG Farbenindustrie to the Dustbin of History, in which I pointed out that the SCC in Sanofi did not apply the IG Farbenindustrie as an independent ground of invalidity on the facts, but rather relied on the standard grounds of anticipation and obviousness, as Zinn J did in this case. That is why it is significant that Zinn J addressed anticipation and obviousness before turning to the IG Farbenindustrie factors; having decided that the 202 patent was valid on the standard principles, there was no more role for the IG Farbenindustrie factors to play. Out of an abundance of caution, Zinn J nonetheless went on to hold that in any event, the 202 patent met the IG Farbenindustrie test [106]–[108].

A Two-Step Approach to Enablement?

Amgen Inc v Pfizer Canada ULC 2020 FC 522 Southcott J
            1,341,537 / filgrastim / NEUPOGEN / NIVESTYM

Wednesday’s post gave an overview of the facts and discussed the main substantive holding in this decision, namely that the invention was obvious. The decision also raised an important point regarding the proper approach to sufficiency, and more particularly enablement (how to practice the invention). I suggest the parties have gone astray, as a consequence of neglecting the FCA’s statements in Leo Pharma 2017 FCA 50 [58] and Bombardier v Arctic Cat 2018 FCA 172 [78] that the SCC decision in Teva 2012 SCC 60 did not change the law of enablement. Ultimately, the doctrinal point made no difference to the outcome, but it is worth discussing nonetheless, as it could cause serious difficulties in future cases.
In Teva 2012 SCC 60 (relating to VIAGRA), the patentee had tried to hide the fact that sildenafil was the particular compound that had been tested and found to be effective in treating ED. LeBel J for the Court stated that:

[80] As a matter of policy and sound statutory interpretation, patentees cannot be allowed to ‘game’ the system in this way. This, in my view, is the key issue in this appeal. It must be resolved against [the patentee].

Whatever one might think of the Court’s policy analysis, its statutory interpretation was the very opposite of “sound”; it would be more accurately described as a horrific train-wreck that particularly mangles s 58, which provides that claims stand or fall independently: see Siebrasse, The Duty to Disclose “The Invention”: The Wrong Tool for the Job, (2013) 25 IPJ 269. The Federal Courts have largely avoided getting tripped up by the SCC’s blithe disregard of doctrinal details and statutory text, and have instead (properly, in my view) understood Teva as representing a broad injunction against attempts to game the system, which was, after all, the “key issue” that was resolved against the patentee.

Unfortunately, Teva’s doctrinal misstep has reared its head in this case, in the context of the approach to sufficiency. The parties both accepted that

[454] In Novopharm SCC, [aka Teva] the Supreme Court set out a two-step analysis for determining whether a patent’s disclosure is sufficient. The first step is to define the nature of the invention in the patent (see Novopharm SCC at para 53). The entire patent must be considered in making this determination, not just a particular claim, as a patent is issued for one invention (see Novopharm SCC at paras 55-60). The second step is to determine whether the disclosure is sufficient to enable the skilled person to practice the invention, i.e. to produce the invention using only the instructions contained in the disclosure (see Novopharm SCC at paras 70-71). None of these principles are controversial between the parties.

The parties disputed whether both of these requirements were to be assessed as of the filing date, or whether the issue date is appropriate for the first step [455].

In my view, the issue of timing is a red herring. I suggest that the parties should not have accepted that these statements from Teva set out the proper approach, as it is wrong in principle and not required by law.

This two-step approach means that sufficiency is assessed in terms of the patent as a whole, and not on a claim-by-claim basis. That is contrary to the principle that claims stand and fall independently. Consider a hypothetical case in which the patent discloses a genus of compounds, as well as two specific especially preferred compounds A and B, all of which are novel, non-obvious, and soundly predicted to have the same utility. Suppose further that the patent provides perfectly clear directions as to how to make compound A, but it is established on the facts that the patent failed to disclose a key step in making compound B, so that it could not have been made without undue burden. (To avoid raising issues of “gaming the system,” we may assume that the failure to disclose how to make B was innocent in that the patentee used as specific brand of equipment that was crucial to success, but did not name the brand because it had not realized its importance: see eg by Badische Anilin (1898) 15 RPC 359 (CA).) The patent claims compounds A and B in separate claims. The sensible result is that the claim to A is valid, and the claim to B is invalid for lack of sufficiency. If the sufficiency requirement is applied to each claim independently, that result is straightforward. But if there is a prior step of determining the nature of “the invention,” a sensible result is out of reach. If the “invention” is compound A, does this mean that the claim to compound B is valid? If the “invention” is compound B, does this mean that the claim to compound A is invalid? If the “invention” is the genus, does this mean the claim to compound A is invalid, on the view that the claim to genus is invalid?

None of these options is a sensible result. Nor does the law force us into an absurdity. The FCA has pointed out in Leo Pharma 2017 FCA 50 [58] and again in Bombardier v Arctic Cat 2018 FCA 172 [78], that Teva did not change the law of enablement: see here. Gauthier JA made the point explicitly in Bombardier [78] (my emphasis):

Enablement (how to practice the invention) is a concept completely distinct from the disclosure of the invention itself, the latter of which was at issue in Pfizer [aka Teva].

The point at issue in the case at hand was enablement, ie that “the disclosure in the patent is not sufficient to practice this invention” [451]. Gauthier J’s holding in Bombardier therefore clearly applies: enablement is “completely distinct” from disclosure of the invention, and Teva should not have been relied on for this point.

This issue ultimately did not matter to the result. The sufficiency issue only arose if the claim was interpreted to require the claim protein to have to be pluripotent in the sense of stimulating growth in multiple cell lineages, [462]. Southcott J rejected this construction, and the sufficiency attack failed for that reason [463]. Nothing turned on the two-stag approach or the timing issue that the parties had disputed.