"Whack the Zombies Dead Once and for All"

Apotex Inc v Abbott Laboratories, Ltd 2018 ONSC 5199 Quigley J

The now defunct rule that a patent would be invalid for lack of utility under s 2 of the Act if the invention failed to meet the promise of the patent is known as the Promise Doctrine. The Promise Doctrine was abolished by the SCC in AstraZeneca 2017 SCC 36 (see here). In a series of cases, defendants have sought to resurrect it in another guise, with almost uniform lack of success. In this decision, another attempt to revive the promise doctrine was rejected by Quigley J in the strongest possible terms.

The decision concerned a motion by Apotex to amend its pleadings in litigation in which Apotex has been seeking damages under s 8 of the NOC Regulations against Abbott and Takeda in the Ontario courts, in respect of lansoprazole [1]. (Some of the history of this very complex litigation is provided here.) Abbott and Takeda have counterclaimed against Apotex for patent infringement, and hence a central issue is the validity of Abbott and Takeda’s patents relating to lansoprazole; if the patents are valid, then damages on the counterclaim will substantially reduce or even entirely negate Apotex’s s 8 damages [4].

Apotex had defended against the counterclaim by alleging the patents were invalid for failure to meet the promise of the patent. Apotex has conceded that as a result of AstraZeneca, these allegations are not longer capable of supporting an argument for invalidity [19]. In this motion, Apotex therefore sought to amend its pleadings to allege invalidity for insufficiency, overbreadth, and material misrepresentation under s 27(3) and s 53 [23], without any changes to the underlying factual allegations [18]. Consequently:

[22] The question on this motion is clear: While abolishing the “Promise Doctrine”, did the Supreme Court nevertheless intend that promise based claims of patent invalidity could now be brought under ss. 27 and 53 of the Act? Apotex says yes. Abbott and Takeda say no.

It is, I think, uncontroversial that prior to AstraZeneca, the Promise Doctrine was not legally coextensive with insufficiency and material misrepresentation. That is, facts which would support an allegation of invalidity for failure to meet the promise of the patent would not necessarily support an allegation of insufficiency or material misrepresentation. For example, in the Olanzapine litigation an attack based on s 53(1) was rejected 2009 FC 1018, [150-53], even though the patent was ultimately held invalid, by the same judge, for failure to satisfy the promise of the patent: 2011 FC 1288, [209]-[210] aff’d 2012 FCA 232. Of course, in some cases the same facts might support multiple grounds for invalidity, just as a single piece of prior art might render a patent invalid for both anticipation and obviousness. 

Apotex therefore argued that AstraZeneca substantively changed the law of insufficiency and material misrepresentation [6]. The argument was effectively that the substance of the Promise Doctrine is still good law, and the only change wrought by AstraZeneca is that it must be pleaded as a matter of s 27(3) or s 53, rather than as a matter of s 2, which is what Apotex's proposed amendments sought to do. In contrast, Abbott and Takeda argued that “AstraZeneca had no effect on the law as it relates to any other ground of invalidity (including insufficiency, overbreadth, or fraud on the Commissioner of Patents)” [17, original emphasis]. 

In support of its position, Apotex relied on the following passage from AstraZeneca (my emphasis):

[45] Supporters of the doctrine assert that the consequences of the Promise Doctrine play a key role in ensuring patentees do not “overpromise” in their patent applications. That is, a patentee will be dissuaded from stating the invention can be used for things that are not sufficiently established at the time of filing if doing so would risk invalidating the entire patent. The utility requirement should not be interpreted, however, as the Federal Courts have done, to address such concerns. Nonetheless, overpromising is a mischief.

[46] The scheme of the Act treats the mischief of overpromising in multiple ways. There are consequences for failing to properly disclose an invention by claiming, for instance, that you have invented more than you have. A disclosure which is not correct and full, or states an unsubstantiated use or operation of the invention, may be found to fail to fulfill the requirements of s. 27(3). An overly broad claim may be declared invalid; however, under the operation of s. 58 of the Patent Act, remaining valid claims can be given effect. As well, this mischief may result in a patent being void under s. 53 of the Act, where overpromising in a specification amounts to an omission or addition that is “wilfully made for the purpose of misleading”.

The question is whether this passage was intended to change the law of sufficiency, overbreadth and material misrepresentation, as Apotex argued, so that they would now reflect the promise doctrine; or merely to acknowledge that some forms of overpromising had always been addressed by those doctrines, as Abbott and Takeda argued. My view is that the latter interpretation is correct. For example, s 53 has an intent requirement of wilful misleading that was never part of the promise doctrine. Wilfully overpromising for the purpose of misleading is undoubtedly a “mischief.” Prior to AstraZeneca it might have engaged both s 53 and the Promise Doctrine; after AstraZeneca it will still engage s 53. But that does not mean that overpromising that was neither willful nor for the purpose of misleading will now engage s 53, even though it might have engaged the defunct Promise Doctrine.

Quigely J held unequivocally in favour of Abbott and Takeda on this issue.

[27] Having specifically overruled the Promise Doctrine as bad law, it is not evident and indeed is counterintuitive that the Supreme Court intended that promise based arguments would simply be imported into claims of overbreadth or misrepresentation under those sections.

Quigley J found support in this conclusion in the consistent holdings to the same effect in the Federal Court [28] (and see here, discussing these holdings). He also cited my blog posts for the position that “we should ‘whack the zombies dead once and for all’” [28]. While I don’t believe I ever said exactly those words, I wish I had, and the statement certainly captures the gist of my comments.

Quigley J then went on to consider whether the factual allegations made by Apotex would nonetheless support an allegation of invalidity under s 53, notwithstanding that it had not initially been pleaded as such [31]-[32]. He concluded that they did not [33], [39].

Further, he awarded costs on the motion on a substantial indemnity basis [48]:

[47] “the caselaw is plain that any party against whom such unfounded and deficient s. 53 fraud allegations are made, in this case Takeda, will be severely prejudiced if they are permitted to be advanced. . . . The allegation alone may severely damage Takeda’s reputation, as well as the reputation of its inventors. The mere publication of fraud allegations causes reputational harm. As such, I agree that the making of the allegation without foundation must entitle Takeda to heightened costs on this motion.

Last Spasms of the Corpse of the Promise Doctrine

Safe Gaming System v Atlantic Lottery Corporation 2018 FC 542 McVeigh J
             2,331,238 / Safe Gaming System

The corpse of the promise doctrine has given a post-mortem gurgle in a problematic utility analysis in Safe Gaming System v Atlantic Lottery Corp. Nonetheless, I doubt this presages a zombie return.

The invention of the ‘238 patent pertains to a system for controlling online gambling. The general scheme of the invention includes an Internet Web site which serves as a portal to Internet-based gambling sites. The user sets up a profile specifying parameters, such as the amount of time spent gambling online or the amount of money lost, and the system cuts the user off from gambling sites when the parameters are triggered. The core of the decision is McVeigh J's holding that the asserted claims are invalid for lack of utility [136]. She also held them to be invalid for insufficiency [159], but not invalid for obviousness [180] or anticipation [184], but the problematic utility analysis permeated her conclusions on the other issues. She also held on the facts that the patent was not infringed by the defendant’s My-Play system [200].

NEXIUM Saga Is Not Over Yet

AstraZeneca Aktiebolag v Apotex Inc 2018 FC 185 Locke J
            2,139,653 / esomeprazole / NEXIUM

While the SCC abolished the promise doctrine in AstraZeneca v Apotex 2017 SCC 36 rev’g 2015 FCA 158 rev’g 2014 FC 638, the associated litigation is not over yet. To recap, Apotex had prevailed in NOC proceedings (2010 FC 714). The subsequent infringement action was bifurcated to carve out any experimental and regulatory use exemption, as well as the quantum of any damages or profits [5]. In the first part of the bifurcated action, AstraZeneca initially lost, on the basis that the 653 patent was invalid for lack of utility, but then ultimately won when the SCC in AstraZeneca abolished the promise doctrine. At first instance, Rennie J had held that the 653 patent was invalid for failure to meet the promised utility, but had rejected all other validity attacks. The FCA had upheld the decision on the basis of lack of promised utility, but did not address Apotex’s appeal of the other validity attacks. In the meantime, Apotex brought a s 8 action consequent on its victory in the NOC proceeding. This went to trial before Locke J, after the SCC hearing but before its decision [9]. The parties agreed that Locke J should not issue his decision until after the SCC had issued its decision [10]. When the SCC decision issued, and after hearing supplemental submissions, Locke J dismissed Apotex’s s 8 NOC claim: 2018 FC 181. The second part of the birfurcated infringement action is ongoing, and this decision concerned motions as to how to proceed in light of the SCC AstraZeneca decision. The difficulty is that SCC had concluded its decision by holding that “The `653 patent is not invalid for want of utility” [64]. Apotex argued that this was not the same as a holding that the patent was valid, and the trial should be re-opened to allow the parties an opportunity to address the validity issues, in particular those which had not been addressed by the FCA, with additional evidence [27]. AstraZeneca, on the other hand, argued that the SCC decision had finally determined the validity of the 653 patent, and consequently the second part of the bifurcated trial, should proceed. Locke J ruled in favour of AstraZeneca, on the basis that he had decided in dismissing Apotex’s s 8 claim, in 2018 FC 181, [30]-[36] that “the validity of the 653 Patent was finally decided by the SCC, and that there remains no other validity issue to debate” [29].

Promise Doctrine Zombie Watch: Part III

Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research 2018 FC 259 Phelan J
            2,261,630 / infliximab / REMICADE / INFLECTRA

In this case (discussed more generally in my previous post), Hospira had initially based its utility argument on “promise of the patent,” but after the trial, AstraZeneca 2017 SCC 36 was released, abolishing the doctrine: [253]. Phalen J allowed the parties to make submissions on the effect of AstraZeneca [254], and Hospira "recast its argument to link 'promise of the patent' to the absence of sound prediction and to insufficiency and overbreadth" [255]. The exact nature of Hospira’s argument is not entirely clear, but what is clear is that Phelan J was having none of it:

[258] Hospira attempts to import the discarded “promise” doctrine into insufficiency and overbreadth. Certainly AstraZeneca does not do so and it would be inconsistent to discard that doctrine only to have it resurface under another principle without clear language to do so.

This is in line with the other post-AstraZeneca cases, which have consistently refused to entertain any attempt to resurrect the promise doctrine in another guise: see here and here.

Promise Doctrine Zombie Watch: Update

Lantech.com, LLC v Wulftec International Inc 2018 FC 41 Annis J

The promise doctrine was abolished by the SCC in AstraZeneca 2017 SCC 36 (see here). Early indications were that it will not rise from the dead. This decision of Annis J confirms that the promise doctrine is so thoroughly dead that it cannot even survive a motion to strike.

The defendant Wulftec sought to amend its statement of claim to add an allegation that the asserted patents are devoid of utility [2]. While it is a bit difficult to understand exactly what was being alleged by the proposed amendments [5], the plaintiff Lantech argued, inter alia, that the allegations were based on an alleged promise of utility in the patent description [6]. Annis J agreed with this submission [7], and concluded that the proposed utility amendments did not meet the requirement of disclosing a reasonable cause of action [8].

Promise Doctrine Zombie Watch

Pfizer Canada Inc v Apotex Inc 2017 FC 774 Brown J

2,436,668 / desvenlafaxine (ODV) / PRISTIQ / NOC

Bristol-Myers Squibb Canada Co v Apotex Inc 2017 FCA 190 [Dasatinib FCA] Gleason JA: Webb, Near JJA var’g 2017 FC 296 [Dasatinib FC] Manson J
            2,366,932 / 2,519,898 / dasatinib / SPRYCEL / NOC

The promise doctrine was abolished by the SCC in AstraZeneca 2017 SCC 36 (see here). Will it rise from the dead, in some other guise? So far, the indications are that it will not.

The issue was addressed by Brown J in Desvenlafaxine (blogged here on the obvious-to-try issue). In its post-hearing submissions directed AstraZeneca, Apotex submitted that the 668 Patent "overpromises" in violation of the requirements of subsection 27(3) of the Patent Act [355]. In particular [356], Apotex argued (emphasis added):

33. As noted above, in AstraZeneca, the Supreme Court directed that overpromising violates the require[ments] of subsection 27(3) of the Patent Act. An invention is subject matter that has demonstrated utility as of the filing date, or subject that matter that constitutes a sound prediction as of the filing date. The statements in the 668 patent to the effect that the compounds of the patent have the utilities (1)-(3) above were thus not 'correct and full' descriptions of the invention but rather were overpromises. As such, they ought to invalidate the 668 patent as a whole.

The argument turns on the SCC’s statement in AstraZeneca [45]-[46] (quoted at [362]):

[45] Supporters of the doctrine assert that the consequences of the Promise Doctrine play a key role in ensuring patentees do not "overpromise" in their patent applications. . . . The utility requirement should not be interpreted, however, as the Federal Courts have done, to address such concerns. Nonetheless, overpromising is a mischief.

[46] The scheme of the Act treats the mischief of overpromising in multiple ways.

The SCC noted [46] that these ways include the disclosure requirements of s. 27(3), overbreadth, and s 53, which provides that a patent is invalid where overpromising in a specification amounts to an omission or addition that is "willfully made for the purpose of misleading".

Does this mean that the promise doctrine is fundamentally sound, and the only error was to implement it through the utility requirement? The answer is no. As Brown J stated:

[360] If the Supreme Court intended to say, in effect, that the Promise Doctrine was not good law in terms of utility under s 2, but was good law in terms of patent specifications under subsection 27(3) it could have done so; it did not.

Moreover, the SCC identified specific functional defects of the promise doctrine – that it risks invalidating an otherwise useful invention [50], and that it impedes fulsome disclosure [51]. As Brown J pointed out, if the SCC removed the promise doctrine from the utility analysis, but functionally replicated it under another name, the “major underlying problem identified by the Supreme Court itself would remain” [363].

Consequently, Brown J rejected Apotex’s argument, agreeing with Pfizer that [361.5]:

Read purposively, the Court was referring to those extraordinary circumstances in which the statements in a patent prevent a skilled reader from understanding "the nature of the invention" or "how it is put into operation." These have always been (and remain) the core requirements of s. 27(3). . .

That is, “overpromising” as the term was used in AstraZeneca, refers to the types of defects that are already addressed by other aspects of the Act. The justifications that have been offered by supporters of the promise doctrine, do not in fact justify that doctrine, because, to the extent that they identify a proper goal of the patent system, those goals are already addressed by other aspects of the Act: see eg AstraZeneca [46]; Siebrasse, The False Doctrine of False Promise, (2013) 29(1) CIPR 3, 51-52; Siebrasse, Form and Function in the Law of Utility, (2015) 30(2) CIPR 109 (generally). The role that is unique to the promise doctrine, and which is not replicated by any other aspect of the Act, namely to protect the discretion of the Crown in the grant of patents, is not an aspect of our patent system: AstraZeneca [45]-[46], citing Siebrasse, The False Doctrine of False Promise, (2013) 29(1) CIPR 3.

Dasatinib FCA, the only FCA decision to deal with utility since AstraZeneca, is important for the guidance it provided regarding the scintilla standard, but Dasatinib FCA also faced a zombie promise doctrine. The SCC in AstraZeneca [54] held that the first step in the utility analysis is to “identify the subject-matter of the invention claimed in the patent.” In Dasatinib, the claim at issue was to the compound dasatinib as such [22] (see here). Apotex argued that the subject-matter of claim 27 of the 932 patent was the potential therapeutic uses for dasatinib [37]. While the FCA did not say so expressly, this seems to have been an attempt by Apotex to raise the promise doctrine in the context of the utility itself; if the therapeutic uses, set out only in the disclosure, were considered to be the subject-matter of the invention, we would be back to the problem of assessing utility against the statements made in the disclosure. The FCA rejected this argument, saying “the subject-matter of claim 27 is merely the compound, dasatinib, itself” [37].

So, both of the post-AstraZeneca decisions to address utility have squarely rejected any attempt to resurrect the promise doctrine. My sense is that the prior to AstraZeneca, the Federal Courts were committed to the promise doctrine as being established law, but not as a matter of patent policy (see eg here), and consequently they have fully embraced the SCC’s repudiation of the doctrine. This contrasts with the reception of the Viagra 2012 SCC 60 decision, which could have been read as undermining the basic principle that claims stand and fall independently: see Siebrasse, The Duty to Disclose "The Invention" (2013) 25 IPJ 269. The courts have rejected this reading (rightly, in my view), and instead interpreted the decision as standing for the principle that a patentee cannot attempt to “game the system”: see here. It is early days yet, but I am nonetheless reasonably confident that we will not see the promise doctrine re-emerge under another guise.

Promise Doctrine Abolished

AstraZeneca Canada Inc. v. Apotex Inc. 2017 SCC 36 rev’g 2015 FCA 158 Dawson JA; Ryer, Webb JJA rev’g 2014 FC 638 Rennie J
            2,139,653 / esomeprazole / NEXIUM

In a unanimous decision, delivered by Rowe J, the SCC has abolished the Promise Doctrine in the Canadian law of utility [2], [24], [36], [37], [51]. I might almost leave it at that. Under law developed in the Federal Courts, Canadian utility doctrine had two branches: the long-established and uncontroversial “scintilla” branch, and the more recent and controversial Promise Doctrine. Because the scintilla branch was never in dispute, and the Promise Doctrine never served any purpose that wasn’t already better served by some other provision of the Act, the Court was able to simply abolish the Promise Doctrine. The result is surgical. The Promise Doctrine was a tumour, but one which had not metastasized. AstraZeneca has cut out the tumour, while leaving the body of utility law unchanged.

The Court’s decision was not based on a narrow technical analysis of the details of the Act or precedent. Rather, it was decided on the basis of fundamental principles. Rowe J called the Promise Doctrine “excessively onerous” [37] and “punitive” [51], and called it “incongruent with both the words and the scheme of the Patent Act” [36], and “antagonistic to the bargain on which patent law is based,” as well as noting that it “undermines a key part of the scheme of the Act” [51].

What is the Promise Doctrine?

Under the law developed by the Federal Courts, the utility requirement had two branches, as summarized in Lilly v Novopharm / Olanzapine (No 1) 2010 FCA 197, [76] (quoted by the SCC at [29], emphasis added by SCC):

Where the specification does not promise a specific result, no particular level of utility is required; a “mere scintilla” of utility will suffice. However, where the specification sets out an explicit “promise”, utility will be measured against that promise:

The first branch represents the traditional utility requirement, which is now generally described as requiring a “scintilla” of utility. The second branch, emphasized by the SCC, is the Promise Doctrine.

A key feature of the Promise Doctrine is that the promise can be found anywhere in the specification [30]. This means that the promise of the patent may be, and in practice normally is, found in the disclosure, as opposed to the claims. Further, if there are multiple “promises” found in the disclosure, the invention must satisfy all of them, or the entire patent will be held invalid [31].

The Promise Doctrine can serve to elevate the requisite utility, often very substantially, above the standard that is required by the Act, as the FCA explained in Plavix 2013 FCA 186, [54]:

An inventor whose invention is described in a patent which would otherwise be valid can nonetheless promise more for his invention than required by the Act so as to render his patent invalid.

In this case, for example, the ‘653 patent claimed esomeprazole, which was a proton pump inhibitor (“PPI”) used for treating gastric disorders [3]. It was uncontested that esomeprazole was indeed useful as a PPI [9], and that use as a PPI was sufficient utility to support a patent [62]. The patent was nonetheless held invalid in the decisions on appeal, on the basis that the disclosure also promised that esomeprazole would be a better drug than existing drugs, and would work better for a wider range of patients [9]. That is more utility than is required for patentability, as it is well established that a new invention need not be better than existing product, if it “affords the public a useful choice”: Consolboard [1981] 1 SCR 504, 525. The only reason to hold the ‘653 patent to this higher standard was a putative “promise” found in the disclosure [63].

Promise Doctrine conflates disclosure and definition

The fundamental problem with the Promise Doctrine is that it conflates disclosure of the invention and definition of the invention [38]. These functions are distinct, and governed by different sections of the Act. The requirement that the patentee disclose the invention to the public is set out in s 27(3), while the requirement that the subject-matter of the invention “be useful” is set out in s 2 [40]. The specification consists of two parts. The first is a narrative portion normally called the “disclosure” (though it is now defined as the “description,”), that, as the name suggests, is primarily responsible for disclosing the invention. The specification ends with “a claim or claims defining distinctly and in explicit terms the subject-matter of the invention for which an exclusive privilege or property is claimed” (s 27(4)). Because the claims define the scope of the monopoly, it follows that validity must also be assessed against the claims: Whirlpool 2000 SCC 67 [49(b)]. Thus the description discloses the invention, the claims define the invention, and it is the invention as claimed, not whatever might have been disclosed, that must satisfy the requirements for receiving the protection of a patent, including the requirement for utility set out in s 2 [40]. Because the Promise Doctrine requires that an invention must satisfy the standard for utility set out in the disclosure, not just the requirement set out in s 2, the Promise Doctrine “effectively imports s. 27(3) into s. 2,” [44] thereby conflating those provisions [38].

Promise Doctrine wrongly invalidates patents which satisfy the requirements of the Act

This is not a technical point. Under the Promise Doctrine, an inventor can be denied a patent, or have a granted patent held invalid, even though the patent satisfies all of the statutory criteria. This happened regularly under the Promise Doctrine; this case is but one example. (See my article, The False Doctrine of False Promise, (2013), 29 CIPR 3, 33 (available here in good draft form) for a summary of the cases up to 2012.) This result is “incongruent with . . . the scheme of the Patent Act” [36], because in Canadian law, a patent is a statutory right; an inventor is entitled to a patent if the invention satisfies the statutory requirements for patentability: Harvard Mouse 2002 SCC 76, [11], [119]; Monsanto [1979] 2 SCR 1108, 119-20. The judge-made Promise Doctrine was contrary to the scheme of the Act because it could result in the inventor being denied a patent to which it was entitled by statute.

Promise Doctrine discourages full disclosure

Thus the Promise Doctrine was inconsistent with the fundamental nature of the patent right under the Patent Act, with the result that inventors were denied patents to which they were entitled by statute. This is bad enough, but the Promise Doctrine also has more insidious effects, extending to patents which are not actually invalidated by the doctrine.

The description and the claims are not just separate parts of the specification, they are functionally separate: the claims define the scope of the monopoly, while the description tells the public how to use the invention. The requirement to both define and describe the invention had long been a part of patent law, but at one time, both functions were served by a single narrative. The difficulty, as was explained over a century ago by Fletcher Moulton LJ, is that “These two things—the delimitation of the invention, and full practical directions how to use it—are in their nature almost antagonistic” (British United Shoe Machinery (1908), 25 RPC 631, 650 (CA), cited at [51]). The patent bargain requires “fulsome disclosure” of how to make and use the invention [51], but defining the invention requires narrow precision, to avoid encompassing subject matter which does not meet the statutory requirements for an invention. This tension was resolved by adding distinct claims to the end of the specification, which serve to define the invention. While now required by statute (s 27(4)), claims were originally implemented by patentees, for their own benefit, so that the requisite fulsome disclosure could be made without any risk that the disclosure would be taken to define the invention, with invalidity as a result. (For a more detailed discussion of the evolution of separate claims and their function, see False Doctrine of False Promise, 43-46.) Hence the rule that “what is not claimed, is disclaimed” (Monsanto 2004 SCC 34, [123]; Whirlpool 2000 SCC 67 [42]). This rule benefits the public, who thereby know the scope of the exclusive rights, but it also benefits the patentee, by excluding statements made in the disclosure alone from the definition of the invention. Under the Promise Doctrine, statements in the disclosure that are intended to describe the invention may be taken to define it, re-creating the very problem that gave rise to claims in the first place: “Thus, the Promise Doctrine undermines a key part of the scheme of the Act” [51].

By undermining the key distinction between disclosure and definition, the Promise Doctrine undermines the disclosure function: “To invalidate a patent solely on the basis of an unintentional overstatement of even a single use will discourage a patentee from disclosing fully, whereas such disclosure is to the advantage of the public” [51]. This chilling effect primarily affects those patents in which the disclosure is limited to avoid the risk of falling afoul of the Promise Doctrine. The abolition of the Promise Doctrine means that patent applicants can make full disclosure without worrying that statements in the disclosure will raise the bar on utility. And, as a practical matter, it means that patent applicants who have drafted their application primarily with the requirements of European or US law in mind will not be taken by surprise on this point when their patent is litigated in Canada.

The Court also held that the Promise Doctrine runs counter to the Act “by requiring that where multiple promised uses are expressed, they all must be satisfied for the patent to meet the utility requirement” [47]; and see also [37]. I see this as largely a corollary of the first point. So, the Court noted that this is potentially unfair because is risks invalidity if all of the multiple promises are not satisfied [50]. But given that a patent must have a scintilla of utility under the first branch to be patentable, even a single elevated promise effectively holds the invention to multiple utilities, namely the “scintilla” which is always required, and the elevated promise. Multiple promises are an exaggerated form of the same problem.

Consolboard is not authority for the Promise Doctrine

If, as the Supreme Court explained, the Promise Doctrine is fundamentally incompatible with the scheme of the Patent Act, how did it emerge in Canadian law in the first place? The answer is that it found its “new home in the Federal Courts’ jurisprudence” [35] on the basis of a narrowly technical misinterpretation of the case law.

The primary Canadian case cited as authority for the promise doctrine is the following passage from the SCC decision in Consolboard [1981] 1 SCR 504, 525 (my emphasis):

. . . the Federal Court of Appeal erred also in holding that s. 36(1) [now s. 27(3) and (4)] requires distinct indication of the real utility of the invention in question. There is a helpful discussion in Halsbury’s Laws of England (3rd ed.), vol. 29, at p. 59, on the meaning of “not useful” in patent law. It means “that the invention will not work, either in the sense that it will not operate at all or, more broadly, that it will not do what the specification promises that it will do”. There is no suggestion here that the invention will not give the result promised. . . .

This passage, and the underlined phrase in particular, is the central authority for the proposition that the promise doctrine was part of the law of Canada: see e.g. Olanzapine (No 1) quoted at [29]. Consolboard is the only pre-2005 Canadian case ever cited by the Federal Courts as authority for the promise doctrine: see False Doctrine of False Promise at 23. (Of course, after 2005, the Federal Courts began citing their own post-2005 case law.)

The SCC in AstraZeneca firmly rejected the proposition that Consolboard is authority for the promise doctrine:

[43] While the above passage [from Consolboard] uses the word “promise” it does not refer to, nor does it embody, the Promise Doctrine.

The problem is that the courts citing Consolboard as authority for the Promise Doctrine seized on the word promise, while ignoring the context. As the Supreme Court emphasized in Consolboard itself, the central point of the decision was that “the Federal Court of Appeal has confused the requirement of s. 2 of the Patent Act defining an invention as new and ‘useful’, with the requirement of s. 36(1) [now s 27(3)] of the Patent Act that the specification disclose the ‘use’ to which the inventor conceived the invention could be put” (527). Indeed, the reason the Court in Consolboard quoted the passage in question was to emphasize this distinction (526). A case that stands for the distinct nature of the disclosure and definition requirements cannot possibly be good authority for a doctrine which runs them together. As Rowe J noted in AstraZeneca:

[38] [T]he Promise Doctrine runs counter to the scheme of the Act by conflating ss. 2 and 27(3) — the very confusion this Court sought to clarify in Consolboard.”

The other pre-2005 authority cited by the Canadian courts was old English case law: see False Doctrine of False Promise at 23. However, that English case law is clearly not good authority for the doctrine in Canada, because the grant of a patent had a fundamentally different foundation than in Canadian law. When the English version of the Promise Doctrine developed, the grant of a patent was not a matter of right, but rather a discretionary exercise of the Crown prerogative, and the basis of the promise doctrine in English law was the “unwillingness of the courts to second-guess the Crown in the exercise of its discretion,” ([35], quoting False Promise of False Doctrine at 17.) As noted above, the grant of a patent is Canada is not discretionary, and it never has been: the Canadian Patent Act was originally based on the U.S. Patent Act, not on English law, and the non-discretionary nature of the grant of a patent in Canadian law follows the U.S. model. Thus the justification for the Promise Doctrine in English law is inapplicable in Canada. Indeed, citing the English case law as authority was especially misplaced because the Promise Doctrine is now “extinct” in English law [35]. It disappeared with the Patents Act, 1977, which formally made the grant of a patent a statutory right, as it always had been in Canada: see Siebrasse, Form and Function in the Law of Utility, (2015) 30 CIPR 109, 126-32 (available here in good draft form). So, Canadian courts were citing English cases as authority for a doctrine which no longer existed in English law. Moreover, the reason it no longer existed is that the scheme of the UK Act had changed to become more similar to that of the Canadian Act. In effect, it is backwards to cite the old English cases as authority for the Promise Doctrine in Canada; the real principle emerging from the English cases is that the Promise Doctrine is “incongruent” with a patent system, like the Canadian system and the modern English system, in which the grant of a patent is a statutory right.

Promise Doctrine serves no purpose not better served by other doctrines

The SCC noted that supporters of the Promise Doctrine assert that it is important to ensure patentees do not “overpromise” in their patent applications [45]. The Court rejected this argument in a brief paragraph. While overpromising is a “mischief” [45], this mischief is treated by the Act in multiple ways [46]. A patent that claims more than it discloses will be invalid for insufficiency under s 27(3), and if a statement in the specification is “willfully made for the purpose of misleading,” the patent will be void under s 53 [46].

I have seen some suggestions that this somehow opens the door to a more aggressive use of the disclosure requirement. In my view, that suggestion is entirely without foundation. This is not a call to arms. The SCC called overpromising a “mischief” not a scourge, and it gave a few examples – “for instance” – of the way the law already “treats” that mischief [46]. The Court gave not the slightest suggestion that these existing treatments were inadequate. Nor, really, did it say the contrary. The Court’s explicit point is that the Promise Doctrine is not the appropriate mechanism for addressing this issue, and other mechanisms exist. To read anything more into the brief discussion would be an error – indeed, the same type of error as was made in building the Promise Doctrine out of a single acontextual phrase from Consolboard.

Correct approach to utility

The SCC’s legal analysis concluded by setting out the correct approach to utility. There is nothing surprising in this discussion, given that the Promise Doctrine has been rejected.

The Court reaffirmed that a “scintilla” of utility is all that is required. While that term has been commonly used in the Federal Court for the last decade, I believe this is the first time the SCC has used the term “scintilla” to describe the standard for utility. It is nonetheless consistent with the older jurisprudence holding that “very little will do”: see e.g. Wandscheer [1948] SCR 1, 24. The Court also noted that “A single use related to the nature of the subject-matter is sufficient.”

The Court also affirmed the holding from Consolboard that “a patentee is not required to disclose the utility of the invention to fulfill the requirements of s. 2” [58]. However, in my view, when the utility would not be evident to a skilled person on the basis of their common general knowledge, or from the nature of the claimed invention itself, as may be the case for a new chemical compound, it may be necessary to disclosure the utility in the specification: see Siebrasse, Must the Factual Basis for Sound Prediction Be Disclosed in the Patent?, (2012) 28 CIPR 39, 56-59. Arguably this is required not as a matter of s 2, which requires only that the invention be useful, but rather to satisfy the disclosure requirement that the inventor describe the invention so that persons skilled in the art can “use the invention as successfully as the inventor could himself” (Consolboard, 526, quoting R. v. American Optical Company). In any event, what is more important for present purposes is that AstraZeneca does not change anything on this point, one way or the other. The question of whether utility has to be disclosed was not at issue in this case, and the Court is simply reaffirming the point already made in Consolboard.

The Court stated that “utility must be established by either demonstration or sound prediction as of the filing date,” citing AZT [55] (my emphasis). This is significant in affirming the filing date, not the priority date, as the appropriate date for assessing utility. AZT itself was ambiguous, or rather inconsistent on this point, referring to both the filing date and the priority date as being the appropriate date. (There was no debate between the parties in AZT on this point, which no doubt accounts for the confusion). Subsequent Federal Court decisions have settled on the filing date: Ramipril 2005 FC 1283, [91]-[96] aff’d 2006 FCA 64, [30]; Quinapril 2007 FCA 209, [153]. Here, the SCC is apparently accepting the filing date as the correct date. The point was not argued in this case – both parties accepted the filing date as the correct date for establishing utility – so the authority is somewhat weaker than if the point had been in dispute, but given the consistent FCA holdings and this statement by the SCC, the point seems settled.

The Court noted that the purpose of the utility requirement is to “avoid granting patents prematurely, and thereby limiting potentially useful research and development by others” [56]. This is a helpfully clear statement, which is consistent with prior caselaw: see e.g. AZT, [56], Wandscheer v Sicard Ltd, [1948] SCR 1, 5, 10. It is also consistent with the position in the US, Europe, and the UK: see Brenner v Manson, 383 US 519 (1966); T 0870/04, BDP1 Phosphatase / Max-Plank, [21]-[22]; T 0898/05 Hematopoietic cytokine receptor / Zymogenetics, [7]; HGS v Lilly, [2011] UKSC 51, [ 91], [102], [107]. This raises the question of how early is too early? The Court went on to say that the utility requirement “is to be interpreted in line with its purpose — to prevent the patenting of fanciful, speculative or inoperable inventions” [57]. This indicates that the line is drawn quite far upstream, as it is only “fanciful, speculative or inoperable inventions” which are excluded. This is consistent with the low “scintilla” standard for utility. But again, we should not read too much into this statement. The question at issue in AstraZeneca was the Promise Doctrine, not the question of how high the bar is for the scintilla standard. The Court’s general statement reaffirms the prior case law and provides helpful guidance in principle, but it does not address, nor does it purport to address, such details.

One general point made by Rowe J is that a use which is acceptable to satisfy the utility requirement must be related to the claimed subject-matter: “a proposed invention cannot be saved by an entirely unrelated use” [53]. That general statement is clarified by the example: “It is not sufficient for a patentee seeking a patent for a machine to assert it is useful as a paperweight” [53]. While I’m not sure I’ve seen that point made in quite this way before, the principle is entirely consistent with established Canadian law; no doubt the reason it has not arisen directly is that no patentee has had the temerity to argue, for example, that a new chemical compound with no known use should be considered useful as landfill. It corresponds to the requirement in US law for a “specific” utility – since any machine could be used as a paperweight, such a use would not be considered specific to the invention (unless, of course, its main purpose was as a paperweight): see Brenner v Manson, 383 US 519 (1966).

The Court also set out a two step analysis for approaching the utility requirement:

First, courts must identify the subject-matter of the invention as claimed in the patent. Second, courts must ask whether that subject-matter is useful — is it capable of a practical purpose (i.e. an actual result)?

The first point is that the utility inquiry is directed to the invention as claimed. In context, this is in contrast with assessing utility on the basis of the invention as disclosed in the specification. The second branch just repeats the utility requirement.

The result in this case

Rennie J at trial had accepted that esomeprazole was useful as PPI (on the basis of sound prediction) [62], and he had held the patent invalid solely on the basis of the failure to meet the elevated promise [62]. Consequently, with the Promise Doctrine disposed of, it was straightforward for the Court to hold the ‘653 patent valid [63], without any need for remand.

Conclusion

The most obvious consequence of AstraZeneca is that patents for good inventions will no longer be invalidated on the basis of a doctrine which “has no basis in the Act” [51]. Legal uncertainty will be substantially reduced, as the actual process of determining the promise of the patent was unpredictable and arbitrary, as I described in The False Doctrine of False Promise, at 35-40. It often happens that when a case reverses or clarifies a problematic doctrine, there is a subsequent period of uncertainty as the law settles into its new form. That should not be a concern in this instance. Because the Promise Doctrine was so idiosyncratic and out of step with the scheme of the Act, its excision leaves no gap to be filled. With the abolition of the Promise Doctrine, Canadian patent law is also brought more into line with our major trading partners. (For example, the Promise Doctrine is one reason the US put Canada on the Special 301 Report Watch List. The SCC decision entirely resolves that concern.)

This does not mean that all is well in Canadian utility law, or that no differences remain between our law and European or US law. Outside of Canada the phrase “promise doctrine” is sometimes used to refer to the entire constellation of quirks in Canadian utility law, but Promise Doctrine dealt with in AstraZeneca refers only to an elevated standard for utility imported from the disclosure. In particular, one point of considerable controversy is the enhanced disclosure requirement for utility based on sound prediction, which requires the factual basis and sound line of reasoning supporting the prediction to be set out in the patent itself (see generally my article, Must the Factual Basis for Sound Prediction Be Disclosed in the Patent?). That doctrine is unaffected by this decision. (The issue was raised at first instance, but only in obiter, and it was not addressed by the Supreme Court.) I have seen it suggested that AstraZeneca overturns that enhanced disclosure requirement, on the basis of the Court’s statement at [58], that a patentee is not required to disclosure utility. The argument, presumably, is that if the patent must disclose the factual basis for utility, the patent must necessarily disclose the utility, but since disclosure of utility is not required, it must follow that disclosure of the factual basis for utility is not required. While there is logic to this reasoning, in my view it is not plausible that the Court intended to eliminate a doctrine that is controversial yet well-established at the Federal Court level, purely by implication, without even referring to it directly. Perhaps there is an inconsistency between the enhanced disclosure requirement and the rule that the patentee is not required to disclose the utility of the invention, but if so, that inconsistency existed ever since the enhanced disclosure was developed, which was long after Consolboard. Put another way, if the enhanced disclosure is bad law, that is because it has always been bad law, and not because AstraZeneca has changed the relevant law. The Promise Doctrine arose as a result of an acontextual over-interpretation of a few words in Consolboard. That is a mistake which should not be repeated in interpreting AstraZeneca.

Barnes J Disagrees with Rennie J as to Whether Enhanced Disclosure Requirement Applies Only in New Use Cases

Eli Lilly Canada Inc v Hospira Healthcare Corp (NOC) 2016 FC 47 Barnes J
            1,340,794 / pemetrexed / ALIMTA

In this decision Barnes J held Takeda’s ‘794 patent (licensed by Lilly [2]) covering pemetrexed to be invalid for lack of sound prediction of utility. The most interesting legal point is that Barnes J rejected Rennie J’s view, expressed in Apotex / esomeprazole 2014 FC 638, that the heightened disclosure requirement for sound prediction applies only in new use cases.

The ‘794 patent relates to a class of compounds including pemetrexed, which, according to the patent “are useful as anti-tumor agents” [31]. All the claims at issue are compound claims. Pemetrexed is not specifically claimed or disclosed, but it falls within Claims 7 and 9 [12], which claim a class of compounds. Only some compounds falling within those claims had been tested as of the filing date, and the key question was therefore whether “the person of skill in 1989 [the filing date] could have soundly predicted the promised utility of the untested compounds falling within Claims 7 and 9 from the test data reported in the Patent and from what was known in the art” [6]. Whether pemetrexed itself was useful was not even discussed, and even if established would have been relevant, at most, as one more data point in a prediction of utility of the untested compounds.

The parties had the usual dispute over the promise of the patent, with Hospira arguing for an elevated promise and Lilly for a much lower one [25]. Barnes J held that the promise was of “in vivo activity in relation to abnormal tissue” [33], which fell in between the position of the parties. The exact basis for his construction of the promise is not entirely clear. Barnes J found the opinions of the experts to be “largely unhelpful” [26], and he emphasized the statement in the patent that the invention relates to “which are useful as anti-tumor agents,” as well as mentioning similar references to “excellent” or “remarkable” antitumor effect [31], [32]. This is consistent with the trend that any phrase stating that the compounds “are useful”, without a qualifier, will be taken as promise, but it is not clear from his brief discussion why Barnes J construed “anti-tumor agent” to mean in vivo activity (though he did note some expert evidence to that effect [33]). The passages in the patent describing “excellent” or “remarkable” effects that were evidently being referenced by Barnes J mixed specific references to in vitro effect with general statements regarding in vivo effect. So, the specification stated that the compounds “have toxicities highly specific to tumor cells and excellent antitumor effects” (p2),; they “show excellent antitumor effects in mouse tumor cell strains (. . .) and human tumor cell strains (...), decrease the tumors carried by warm-blooded animals . . . and prolong the life-span of tumor-carrying warm-blooded animals” (p25); they “are excellent in inhibition of cell growth of [specified cell lines], while they do not exert a toxicity against [specified cell line]. The compounds (I) of this invention and the salts thereof are of low toxicity, having remarkable antitumor effect. Therefore, the preparations containing the compound (I) or salts thereof can be employed as antitumor agents for the treatment of tumors in warm-blooded animals, particularly mammals. . . .” (p27). The examples of the effects disclosed in the patent all referred to cell lines.

While the references to treatment of tumours in mammals support the view that the patent promised in vivo activity, recall that in Plavix 2013 FCA 186 (here), the FCA encouraged a restrained approach to construction of the promise of the patent, requiring that a promise be explicit [49], [50] and cautioned against ignoring “the distinction drawn in the jurisprudence between the potential use of an invention and an explicit promise to achieve a specific result is considered.” [67]. In Plavix the FCA held that the statement in the ‘777 patent that “the medicine of the invention can be usefully administered in the treatment and prevention of platelet disorders due to extracorporeal blood circuits or the consequence of complications in atheroma,” relied on by the trial judge [163] as indicating an explicit promise of use in humans, was no more than an indication of the “potential use in humans” which was “foreshadowed” in the patent [67]. It strikes me that it is at least arguable that the promise of the ‘794 patent could have been construed similarly, with the specific references to in vitro activity constituting the promise, and the more general references to in vivo treatment cell being foreshadowing of the potential use in humans. Barnes J’s construction of the promise in this case illustrates two points. First, while Plavix seemed to be a signal from the FCA that a more restrained approach should be taken to construing the promise of the patent, the reality seems to be that Plavix has had little effect; as I put it in the title of an earlier post, the “Promise of the Patent is Alive and Well Post-Plavix FCA.” The very brevity of Barnes J’s analysis of the promise emphasizes this point. Despite Plavix, he did not consider it necessary to explicitly consider the possibility that references to in vivo use were merely references to a potential use. The second point is the difficulty in predicting how the courts will construe the promise of the patent, in light of the variety of language touching on utility that is typically found in the disclosure. In this case, as noted above, the court considered that neither party’s submissions were even helpful.

In any event, in the end, Barnes J expressly rejected Lilly’s position that “any measurable in vitro antifolate activity would satisfy the promise of the Patent” [35], which he characterized as “effectively read[ing] the promise down to a ‘scintilla’ of utility” [25], so that Barnes J clearly held utility should be measured against a higher standard of utility than the scintilla that would be required in the absence of an express promise (though it is not clear that Lilly’s position really did amount to asserting a mere scintilla of utility as contrasted with a low promised utility).

On the main legal point of interest, recall that in Apotex / esomeprazole Rennie J, drawing in part of Gauthier J’s concurring remarks in Plavix 2013 FCA 186, held that the effect of the SCC’s obiter remarks in Viagra 2012 SCC 60 was to overturn previous FCA decisions, such as Raloxifene 2009 FCA 97 aff’g 2008 FC 142, which had held that there is a heightened disclosure requirement in all cases where utility is established by sound prediction, such that the factual basis for that prediction and the line of reasoning must be disclosed in the patent itself [142]. On Rennie J's view, the heightened disclosure requirement is now “limited to the context of ‘new use’ patents, assuming such a utility disclosure requirement exists at all” [141]. Barnes J disagreed, saying:

[48] While I have some sympathy for Justice Rennie's and Justice Gauthier's views, I am not persuaded that the state of the law on this issue has changed. In particular, it would take something more than Justice LeBel's apparent reservations [in Viagra] to displace the requirement for disclosure described by Justice Binnie in [AZT 2002 SCC 77] and, later, as clearly endorsed by the Federal Court of Appeal in [Raloxifene 2009 FCA 97], in [Olanzapine (No 1) 2010 FCA 197] and in many decisions of this Court.

Banres J therefore held that “where utility is based on a sound prediction, there remains an obligation to disclose in the patent specification the factual basis and a sound line of reasoning supporting the prediction” [49] I can’t agree with Barnes J’s suggestion that the cryptic comments of Binnie J in AZT established a requirement to set out the factual basis for a sound prediction in the patent itself, but the FCA decisions cited by Barnes J certainly did. And while Rennie J’s interpretation of AZT is very interesting in its own right, Barnes J makes a fair point in doubting whether the effect of Justice LeBel’s comments in Viagra was to overrule the FCA’s line of authority on this point. With both Rennie JA and Gauthier JA now on the FCA, this issue will no doubt be authoritatively decided at that level in due course.

Having accepted the established FCA case law, Barnes J held that Lilly could not rely on in house testing or a line of reasoning not found in the patent in order to establish a sound prediction of antitumour activity [51]. He noted that Lilly’s expert “based his opinion of a sound prediction of utility substantially on data that was not disclosed in the Patent” [53], and also that the patent “provides no line of reasoning from which the person of skill could draw a prima facia reasonable inference that the thousands of untested claimed compounds would be useful as antitumor agents in vivo or even in vitro” [51], or that would allow an inference of in vivo activity to be extrapolated from the reported in vitro data [52]. These “fundamental flaws in Lilly’s case” [54] would have sufficed to dispose of the case on the law as set out by Barnes J, but he nonetheless went on to address the evidence relied on by Lilly [54]. After reviewing the evidence of Lilly’s main expert on utility, including evidence not found in the patent (eg [65]), he concluded that “I do not agree with Lilly that a person of skill would have made a prediction of utility for the thousands of untested compounds included in the asserted claims. This is equally the case if one accepts Lilly’s assertion of the promise of the subject claims as being merely some antifolate activity in some cell line in vitro” [116] (and see similarly [108]). This indicates that Barnes J would have reached the conclusion that the patent is invalid even if he assessed utility against the standard proposed by Lilly and in light of all the evidence presented by Lilly.

Inventive Concept and the Promise of Utility Are Not Necessarily Coextensive

AstraZeneca Canada Inc v Apotex Inc / esomeprazole 2015 FCA 158 Dawson JA; Ryer, Webb JJA aff’g 2014 FC 638 Rennie J
            2,139,653 / esomeprazole / NEXIUM

The FCA’s brief Esomeprazole decision affirms a couple of important points that were raised in yesterday’s post (which I wrote before having read the FCA decision).

An initial, basic point is that the FCA affirmed Rennie J’s holding that the patent was invalid for failing to satisfy the promise of the patent, which was higher than the mere scintilla necessary to support a patent. As I remarked in my post on Rennie J’s decision, this shows that “the promise doctrine is alive and well post-Plavix FCA 2013 FCA 186.” This is not entirely surprising, as Plavix formally reaffirmed the promise doctrine, holding only that the promise must be explicit, but with the FCA’s affirmance in this case any thought that Plavix was the first step towards abandoning the doctrine entirely must now be laid to rest.

The FCA also stated that “[i]t is also now settled law that some promises can be construed to impose utility requirements across each of a patent’s claims, while other promises may touch only a subset of the claims,” citing Celecoxib 2014 FCA 250 (blogged here). While Rennie J in this case did not construe the promise on a claim-by-claim basis, the FCA held this was not an error in light of the evidence and submissions before him [6]. As noted in yesterday’s post, the distinction between overarching and claim-specific promises was applied by O'Reilly J in his Deferasirox decision.

AstraZeneca also argued that “the Federal Court erred by construing the utility of the claims in issue in a manner inconsistent with their inventive concept. AstraZeneca argues that because it is a fundamental rule of claim construction that a claim receives one interpretation for all purposes, there must be a unitary, harmonious understanding of the essential elements of the claim, inventive concept and utility” [10]. The FCA rejected this proposition as being unsupported by any jurisprudence. In my view, this holding is entirely correct. To elaborate on an example given in yesterday’s post, suppose a racemic compound is known to treat cancer though with side effects, and it is obvious to a skilled person that one of the enantiomers is therapeutically effective while the other is responsible for the side effects, but it is unusually difficult to resolve the enantiomers. If a patentee succeeds in resolving the enantiomers through inventive ingenuity and claims the therapeutically effective enantiomer, the claimed invention is surely patentable. But if the inventive concept and the promise of utility are coextensive, it would be held invalid; the enantiomer is useful, because it treats cancer (without side effects), but that was obvious to anyone. The reason the claim is valid is that the inventive concept, namely the method of separating the enantiomers, is distinct from the utility.

Application of Distinction Between Overarching Promise and Claim-Specific Promise

Novartis Pharmaceuticals Canada Inc v Teva Canada Ltd (NOC) 2015 FC 770 O'Reilly J
            2,255,951 / deferasirox / EXJADE

As discussed in Monday’s post, the ‘951 patent relates to iron chelators, which are used to treat disorders caused by excess iron in the body [7]. As usual, the utility attack turned on the promise of the patent. O'Reilly J’s Deferasirox decision illustrates once again that under the promise doctrine the validity of the patent will turn on a meticulous reading of the disclosure. It is also interesting as applying the recently developed distinction between an “overarching” promise, which will affect all claims, and a promise that is directed at one claim only. One point I would quibble with is that there seems to have been an implicit assumption that the stated utility is the same as the inventive concept. Consequently, while O’Reilly J explicitly stated that (for the compound claims) he applied the low standard for utility that applies in the absence of an explicit promise, the standard he actually applied was higher than a mere scintilla.

Promise of the Patent and Obviousness

Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC / tadalafil (NOC) 2015 FC 125 de Montigny J
            2,371,684 – tadalafil dosage form – CIALIS

In Plavix 2013 FCA 186 the FCA held that utility will only be measured against the promise of the patent when an “explicit” promise is made and “it should not be taken to have assumed that every patent contains an explicit promise” [49]-[50]. As I noted in my post on that decision “The crucial question will be how explicit a promise must be in order to establish the standard for utility.” I predicted that direct statements of use such as ‘The compounds of this invention . . . are useful” for a particular purpose would be treated as promises. de Montigny J’s decision in Tadalafil Dosage Form confirms this prediction. (For a similar decision, see also 2014 FC 638, blogged here). Consequently, it seems that while Plavix may have restrained some of the more aggressive applications of the doctrine, the promise of the patent remains very much a central feature of Canadian patent law. The case also illustrates that the promise doctrine is unnecessary to deal with defects that are better addressed by the non-obviousness requirement.

It’s significant that de Montigny J began his discussion of utility with the following statement:

[85] The promise of a patent is fundamental to the utility analysis and must be ascertained at its outset. As stated by the Federal Court of Appeal in Sanofi-Aventis v Apotex, 2013 FCA 186, at para 47, “[t]he promise of the patent is the standard against which the utility of the invention described in the patent is measured”.

This would have been uncontroversial pre-Plavix, but it is difficult to square with the holding in Plavix that “it should not be taken to have assumed that every patent contains an explicit promise.” This reversion to this pre-Plavix premise suggests that Plavix’s impact may be quite limited.

The ‘684 patent was for tadalafil in a dosage form of less than 20mg. Lilly’s position was that the promise of the patent is that the claimed doses are efficacious and have a better side effects profile than sildenafil [86], while Mylan argued that the patent promised not just an improved side effects profile, but to reduce side effects to “clinically insignificant levels” [95]. The particular side effects in question were flushing, vision abnormalities, and a potentially life-threatening reduction of blood pressure when tadalafil is co-administered with nitrates, which are used to treat heart conditions. The last was most important because it is potentially fatal [90].

Key language in the patent included the following statements [93]-[94]:

Most unexpectedly, the product also can be administered with clinically insignificant side effects associated with the combined effects of a PDE5 inhibitor and an organic nitrate. Thus, the contraindication once believed 20 necessary for a product containing a PDES inhibitor is unnecessary when Compound (I) is administered as a unit dose of about 1 to about 20 mg, as disclosed herein. (4)

The present invention is based on detailed 25 experiments and clinical trials, and the unexpected observations that side effects previously believed to be indicative of PDE5 inhibition can be reduced to clinically insignificant levels by the selection of a compound and unit dose. (10)

de Montigny J construed this and other similar language as promising a reduction of side effects to clinically insignificant levels. The promise was held not to be satisfied, in part because co-administration of tadalafil and nitrates is strictly contraindicated by both US and Canadian health regulatory authorities [61]. Thus, the patent was construed as promising a regulatory standard of utility [99]. Since it is well-established that regulatory approval is not the general standard for patentable utility, it is clear that the patent was construed as promising a much higher utility than the minimum which would be required to establish patentable utility in the absence of an explicit promise.

Consequently, the patent was held to be invalid for failing to meet this stringent standard for the promised utility [122]. However, the heightened promise was not determinative, as de Montigny J held that even the promise proposed by Lilly, namely an improved side effects profile as compared with sildenafil, had not been established [144].

This decision shows that the promise doctrine continues to play a central role in the Canadian law of utility. I have been and continue to be critical of that doctrine: see Form and Function in the Law of Utility: A Reply to Gold & Shortt, (2015) 30(2) CIPR 109 (draft version available here). As I see it, even Lilly put the promise too high. The ‘684 patent is clearly useful, because the claimed invention is effective in treating ED.

With that said, the fact that tadalafil does not have an improved side effects profile as compared with sildenafil is certainly relevant to the validity of the '684 patent, but it goes to obviousness, not utility; and, as discussed yesterday, the patent was properly held to be invalid on that basis. Indeed, the question of whether the side effects are reduced to clinically insignificant levels is relevant to obviousness. This is not because obviousness is measured against statements made in the patent. Rather, as discussed in yesterday’s post, on the facts a reduced dosage is expected to result in reduced side effects, and therefore a reduced dosage form would only be inventive if the side effects were reduced to an unexpected degree. The assertion that the side effects were reduced to clinically insignificant levels was likely made to convince the examiner that the reduction in side effects was sufficiently unexpected to satisfy the inventive step requirement. This does not mean that the patentee should be held to such promises of utility, as some have suggested. On the contrary, it is will established that the standard for obviousness is objective; it is what a skilled person would find obvious, not what the inventor thought was obvious. (See eg Nichia Corporation v Argos Ltd, [2007] EWCA Civ 741 [13].) The proper response is simpler. Regardless of what the patentee might have “promised” or not “promised” if the reduction in side effects are not in fact large enough to be unexpected to a person skilled in the art, then the patent will be invalid for obviousness. That is exactly what happened in this case.