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.

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.

"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.

The Promise of the Patent Must Be Explicit

Sanofi-Aventis v Apotex Inc / clopidogrel 2013 FCA 186 Pelletier JA, concurred in by Noël, Gauthier JJA; separate concurring reasons by Gauthier JA, rev’g 2011 FC 1486 Boivin J
            1,336,777 – PLAVIX

In Canadian law, utility is measured by the promise of the patent:

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 question is whether the invention does what the patent promises it will do.

[47, original emphasis] quoting Olanzapine (No 1), 2010 FCA 197 [76]

This doctrine has resulted in a number of pharmaceutical patents being invalidated, and in my article “The False Doctrine of False Promise,” (2013) 29 CIPR 3 (draft version available here), I argued that the promise doctrine is both unsound in principle and contrary to the Canadian Patent Act. The FCA is evidently of the contrary opinion, as the Court expressly and emphatically reaffirmed that “The promise of the patent is the standard against which the utility of the invention described in the patent is measured,” [47]: and see [48], quoted above. The FCA also expressly affirmed what I have argued is the most objectionable aspect of the promise doctrine: “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” [54].

However, the FCA did significantly modify the doctrine, by emphasizing that the promise must be explicit, and that not every patent necessarily contains a promise (my emphasis):

[49] If the inventor does not make an explicit promise of a specific result, the test for utility is a “mere scintilla” of utility. If, on the other hand, the inventor makes an explicit promise of a specific result, then utility will be assessed by reference to the terms of the explicit promise.

[50] When this Court said at paragraph 80 of Olanzapine, cited above, that the promise of the patent must be ascertained, it should not be taken to have assumed that every patent contains an explicit promise of a specific result since, subject to what is said below with respect to selection patents, there is no obligation on the part of the inventor to disclose the utility of his invention in the patent. In Olanzapine, the Court was simply indicating that the firs step in assessing utility was to determine the standard against which utility will be measured. This requires the Court to construe the patent to determine if a person skilled in the art would understand it to contain an explicit promise that the invention will achieve a specific result. If so, the inventor will be held to that promise. If there is no explicit promise of a specific result, then a mere scintilla of utility will do.

Moreover, on the facts, the FCA reversed Boivin J on the basis that “He erred in law in reading into the ‘777 patent a promise for use in humans on the basis of inferences, in the absence of language at least as clear and unambiguous as that used to establish the advantages of the selection over the compounds of the genus patent” [66]. The FCA held that the patent made no promise [71], and therefore the fact that the invention had sufficient utility to support a selection patent was enough.

While the FCA Clopidogrel decision is formally consistent with the prior case law, the decision departs from the current practice both in the Court’s insistence that the promise must be explicit for it to serve as the touchstone for utility, and in emphasizing that not every patent has such a promise. The focus in previous cases has been to determine what the promise of the patent was, and not whether the patent contains a promise at all. So, in Olanzapine (No 1) the FCA said “The promise of the patent must be ascertained, [80] and “the promise of the patent is to be ascertained at the outset of an analysis with respect to utility” [93]. Clopidogrel implies that this is no longer entirely accurate, as it must first be ascertained whether the patent has a promise at all. Because the of need to ascertain the promise, if the language of the specification was not express, it would be finely parsed to extract a promise. Clopidogrel holds that this fine parsing is also misguided.

If Clopidogrel represents the law going forward, we should expect to see utility measured by the promise less often, and consequently, fewer utility attacks will be successful. The crucial question will be how explicit a promise must be in order to establish the standard for utility. Given that the doctrine was specifically affirmed, and given that the specification never has a statement beginning “This patent promises...”, I expect that direct statements of use such as “The compounds of this invention . . . are useful in the treatment of high blood pressure [and are] useful in the treatment of cardiovascular disorders and particularly mammalian hypertension” will be treated as an explicit promise: see Sanofi v Apotex / Ramipril 2009 FC 676 [122]. But where exactly the line of “explicitness” will be drawn is difficult to predict for any given patent. As I noted in my False Promise article at 41, “The root of the difficulty is that, under the promise of the patent doctrine, the utility of the invention is defined in the disclosure. The traditional purpose of the disclosure is to describe how to make and use the invention.” This disconnect remains, even if the promise must be explicit.

I said “if Clopidogrel represents the law going forward,” because it is not clear whether the views of this panel represent the views of the Court as a whole, particularly in light of Pfizer v Apotex / latanoprost (NOC) 2011 FCA 236 in which Trudel JA (Sharlow, Stratas JJA concurring), very aggressively implied a promise which was certainly not explicit in the patent. Latanoprost and Clopidogrel simply cannot be reconciled, and Clopidogrel made no attempt to do so; the Latanoprost decision was never mentioned. The question is whether we have a split in the FCA – the two decisions did not share any judges – or whether Clopidogrel represents a new consensus. If the former, then the outcome of promise cases on appeal will depend on the particular panel of the FCA. I note that the two other FCA decisions since Latanoprost endorsed a modest interpretation of the patent: Anastrozole (NOC) 2012 FCA 109 Evans JA: Sharlow, Dawson JJA (blogged here) and Donepezil (NOC) 2012 FCA 103 Mainville JA: Sharlow, Gauthier JJA (blogged here), in which the FCA remarked that “the jurisprudence does not permit an unescorted and unchaperoned romp through the disclosure” [57]. This suggests that Clopidogrel represents the culmination of a trend, but I am hesitant to draw firm conclusions; with a such a small sample size, it may be that this is not a trend at all, but a reflection of the composition of the particular panels.

On the whole, the FCA Clopidogrel decision is a very welcome development which should restrain some of the worst excesses of the false promise doctrine. However, restraining those excesses is as far as the FCA was willing to go. This is the most extensive consideration of the promise of the patent doctrine that the FCA has undertaken. That the Court reaffirmed the doctrine at the same time that it significantly restricted it, means that there is no question but that the promise of the patent doctrine will remain part of Canadian law, at least until the SCC might choose to deal with it. That is unfortunate, as I remain of the view, expressed in my False Promise article, that the doctrine is unjustifiable in any version; but as the saying goes, half a loaf is better than none.

No Sign of Changed Approach to the Promise Doctrine in First Post-Clopidogrel FCA Decision

Eurocopter v. Bell Helicopter Textron Canada Limitée 2013 FCA 219 Mainville JA: Noël, Trudel JJA aff’g 2012 FC 113 Martineau J
            2,207,787

While the promise of the patent doctrine and the requirement that the factual basis for sound prediction be disclosed in the patent are most closely associated with pharmaceutical patents, the FCA Eurocopter decision is significant on both issues, particularly when contrasted with the recent FCA Clopidogrel decision 2012 FCA 186. This post deals with the promise doctrine, while the next will deal with the factual basis issue. An overview of the facts in Eurocopter is provided in my last post.

In Clopidogrel decision, as discussed here, the FCA re-affirmed the promise doctrine, but it also adopted a relatively restrictive approach to construing the promise, emphasizing repeatedly that the promise must be “explicit,” and also noting that it should not be assumed that every patent has a promise. The question remains as to whether this change in tone will generate a real change in practice. Eurocopter is the first FCA decision since Clopidogrel to consider the issue. In Eurocopter the FCA affirmed, with little discussion, a fairly aggressive pre-Clopidogrel style of interpretation of the promise. Since Eurocopter was argued before Clopidogrel was released, this may simply reflect the fact that counsel would not have argued the Clopidogrel requirement for an express promise, and the FCA did not feel inclined to review the trial judge’s construction of the promise on its own initiative. But it is disquieting that the FCA simply accepted Martineau J’s construction, without even reference to the Clopidogrel approach.

The Promise of Selection Patents

Sanofi-Aventis v Apotex Inc / clopidogrel 2013 FCA 186 Pelletier JA, concurred in by Noël, Gauthier JJA; separate concurring reasons by Gauthier JA, rev’g 2011 FC 1486 Boivin J
            1,336,777 – PLAVIX

The ‘777 patent at issue in Clopidogrel is a selection patent over Canadian patent 1,194,875. This decision illustrates how the promise of the patent doctrine has distorted the analysis of selection patents in Canadian law, but it also illustrates that ultimately nothing turns on this. This reinforces the view that it may be time to abandon the doctrine entirely.

In Clopidogrel the FCA re-affirmed the point made by the SCC in Sanofi 2008 SCC 61 [9] and subsequently by the FCA in Olanzapine (No 1) 2010 FCA 197 [33] that “a selection patent is like any other patent” [44], in that it must satisfy the requirements that the invention be new, useful and non-obvious. It is also clear that in order to be valid, a selection patent must possess some unexpected property as compared with the genus, be it the presence of an advantage or the avoidance of a disadvantage. The question then, is whether the unexpected property is required as a matter of utility, or as a matter of non-obviousness?

Promise of the Patent Is to Be Found in the Claims

Fournier Pharma Inc. v. Sandoz Canada Inc. 2012 FC 741 Zinn J
            NOC; fenofibrate; LIPIDIL EZ; 2,372,576

Zinn J’s Fournier / fenofibrate (NOC) decision turned primarily on claim construction and infringement, but hidden in the brief treatment of validity of the ‘576 patent there is a very important passage regarding the promise of the patent which deserves to be quoted in full (Zinn J’s emphasis):

[126] The Federal Court of Appeal in Eli Lilly Canada Inc v Novopharm Limited, 2010 FCA 197, citing Consolboard Inc v MacMillan Bloedel (Sask)Ltd, [1981] 1 SCR 504, stated at para 76 that “where the specification sets out an explicit ‘promise’, utility will be measured against that promise [emphasis added].” The promise of a patent, as that term is used in patent law, is nothing more than the utility the inventor claims for his invention. Where that promise – that claimed utility – is clearly and unequivocally expressed by the inventor in the claims of the patent, then that expression ought to be viewed as the promise of the patent. Any statement found elsewhere should be presumed to be a mere statement of advantage unless the inventor clearly and unequivocally states that it is part of the promised utility. The following from page 1 of the patent in AstraZeneca Canada Incv Apotex Inc, 2010 FC 714, is illustrative of such a statement found in the disclosure:

It is desirable to obtain compounds with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation. The present invention provides such compounds, which are novel salts of single enantiomers of omeprazole [emphasis added].

[127] The interpretation should be focused on the claims because an inventor is not obliged to claim a monopoly on everything new, ingenious, and useful disclosed in the specification. If, as here, the claims are certain and unambiguous in stating the promise, then the disclosure should not be examined microscopically to find additional promises that are outside the scope of the inventor’s claimed monopoly.

Consequently, Zinn J concluded at [128] that “I find, as stated in claim 1, that the promise of the patent is a “fenofibrate composition … having a dissolution of at least 10% in 5 minutes, 20% in 10 minutes, 50%in 20 minutes and 75% in 30 minutes” (my emphasis). As I have emphasized, this promise directly reflects the wording of the claim itself.

While Zinn J’s remarks are very clear and he has provided his own emphasis, almost the entire passage could be highlighted, so I will add some of my own:

Where that promise – that claimed utility – is clearly and unequivocally expressed by the inventor in the claims of the patent, then that expression ought to be viewed as the promise of the patent. Any statement found elsewhere should be presumed to be a mere statement of advantage unless the inventor clearly and unequivocally states that it is part of the promised utility. . . 

If, as here, the claims are certain and unambiguous in stating the promise, then the disclosure should not be examined microscopically to find additional promises that are outside the scope of the inventor’s claimed monopoly.

Zinn J’s focus on the claims is in sharp contrast with the trend of the recent Canadian cases, which is to extract the promise of the patent from a searching, sometimes “microscopic,” analysis of the disclosure. This is usually done in an ad hoc manner, though Rennie J in Astrazeneca / anastrozole (NOC) has recently used a more structured approach; but however it is done, the focus is almost always on finding a statement of the promise in the disclosure. One exception which proves the rule was Pfizer v Apotex / latanoprost (NOC) 2011 FCA 236, blogged here, in which the FCA interpreted the promise in light of the common general knowledge, without reference to the disclosure, much less the claims.

While Zinn J’s approach is a departure from recent Canadian trends, it is consistent with the English cases which developed the false promise doctrine. In Alsop’s Patent (1907) 24 RPC 733 at 753 (Ch), one of the leading cases on the promise of the patent, Parker J noted “the importance of drawing a distinction between what the patentee claims to have effected by the invention for which he claims protection [ie the promise of the patent], and a statement of the additional purposes to which the invention can be applied.” That is, not every statement of advantage in the specification is to be treated as a promise. Put another way, in order for validity to turn on a promise made in the specification, the promise must be “material” in the sense that it can be said that the patent was obtained on the strength of the promise: Alsop’s Patent, ibid, Raleigh Cycle Co Ltd v H Miller & Co Ltd, (1948) 65 RPC 141 at 162 (HL). This point seems to have been largely forgotten in recent Canadian case law, in which the disclosure is examined to extract a promise without regard to whether that promise is material. Zinn J’s approach amounts to a presumption that a promise is material only if it is found in the claims. This presumption is consistent with the general rule that the invention is defined by the claims, not by the specification. Consequently, it helps address one of the most problematic aspects of the false promise doctrine, which is that validity of the patent will often turn on a “microscopic” construction of the disclosure. This is a trap particularly when, as is normally the case, the patent was drafted in light of US and European law, which do not have a false promise doctrine.

Notwithstanding the FCA decision in Pfizer v Apotex / latanoprost (NOC), a few recent cases suggest that the FCA has recognized the need to put some bounds on the false promise doctrine by approving relatively moderate constructions of the promise (see here and here). The difficulty with relying on the trial judge to adopt a moderate approach to construction of the promise is that there may be considerable arbitrariness in the result, depending on how aggressive a particular judge chooses to be in construing the promise. The approach of Rennie J in Astrazeneca / anastrozole (NOC) (blogged here) is one attempt to provide a principled legal structure to the construction of the promise, and Zinn J’s approach is another. I prefer Zinn J’s approach for its focus on the claims, as opposed to Rennie J’s approach, in which the focus remains on the disclosure. In any event, it is gratifying to see the Federal Court grapple directly with the legal structure of this problematic doctrine.

The Argument in Favour of the False Promise Doctrine

I have been critical of the false promise doctrine in past posts, but few arguments are entirely one-sided. The argument in favour of the false promise doctrine is obscured because the traditional justification is based on the theory that the Crown has been deceived in the grant. This theory is unpersuasive in the modern patent system in which a patent is obtained as of right for an invention that is substantively patentable. So, Blanco White §4-403 cites Hatmaker v Nathan (1919) 36 RPC 231 (HL) for the proposition that “where a patentee promises (expressly or impliedly) the attainment of a certain result, and this is not obtained, . . .the patent will be invalid: for ‘protection is secured by the promise of results; it does not, and ought not to, survive the proved failure of the promise to produce the results,’” and then in the footnote he remarks acerbically that “It is not, of course, in actual fact; but the House of Lords has repeated this dictum until it is of unimpeachable authority.”

The better defence of the doctrine is based on the modern understanding of the purpose of the utility doctrine, which is to govern how far upstream in the R&D process an invention may be patented.

Imatinib – Promise of the Patent

Teva Canada Ltd v Novartis AG / imatinib 2013 FC 141, Snider J

            GLEEVEC / imatinib mesylate / 2,093,203

Imatinib has proven to be a revolutionary treatment for chronic myeloid leukemia: “What once was a death sentence has now become a manageable chronic illness with overall survival rates equal to the general population” [71]. The ‘203 patent includes a compound claim to imatinib (Claim 29) and a claim to the use of imatinib for the treatment of tumours (Claim 46, read together with Claim 29) [184]. These were the key claims at issue, and both were held to be valid. (Other important claims included Claim 1, the broadest genus claim, which was held to be invalid, and Claim 5, a sub-genus claim encompassing imatinib, which was held to be valid. A number of other claims to individual compounds were also held to be valid.)

As is now standard with respect to pharmaceutical patents, the main attack on the patent was based on lack of utility [8], and a key argument turned on the promise of the patent. In the end, Snider J construed the promise modestly, in favour of the patentee, but her decision illustrates once again that under the false promise doctrine, validity of a pharmaceutical patent may turn on an extraordinarily fine parsing of the description. Whatever the result, this is problematic, as the description is intended to disclose the invention, not to define it; the false promise doctrine means that the same meticulous care that must be given to every word of the claims, should also be given to every word of the description when drafting a Canadian patent application.

Promise of the Patent is Alive and Well Post-Plavix FCA

AstraZeneca Canada Inc v Apotex Inc 2014 FC 638 Rennie J
            2,139,653 – esomeprazole – NEXIUM

Rennie J’s decision holding AstraZeneca’s esomeprazole patent invalid is interesting in several respects. Most importantly, Rennie J held that the effect of the SCC’s obiter remarks in Teva / sildenafil 2012 SCC 60 is to overturn previous FCA decisions holding that the factual basis for utility must be disclosed in the patent itself in all cases of sound prediction [142]. On Rennie J's view, the disclosure requirement is now “limited to the context of ‘new use’ patents, assuming such a utility disclosure requirement exists at all” [141]. On the other hand, his decision also shows that the promise doctrine is alive and well post-Plavix FCA 2013 FCA 186. This is not surprising, as the FCA affirmed the doctrine, and held only that the promise must be explicit. Rennie J’s decision makes no new law in this respect, though it gives some guidance as to what will be considered an “explicit” promise. On a third point, Rennie J also has an interesting analysis of what is meant by the “inventive concept” in the obviousness analysis. Ultimately, Rennie J held the ‘653 patent invalid solely for failure to meet the promise of the patent. This post will provide background and deal with the promise issue. Subsequent posts will deal with disclosure and obviousness.

The claims at issue, primarily claims 7 and 8 of the ‘653 patent [79], are compound claims to six specified salts of esomeprazole of high optical purity. “Esomeprazole,” is synonymous with the (-) enantiomer of omeprazole [61]. As of the priority date, the skilled person would have known that omeprazole is a racemate, containing equal amounts of (-) and (+)-omeprazole; that omeprazole is a proton pump inhibitor (PPI) and is useful as an inhibitor of gastric acid secretion and for the treatment of gastric acid-related diseases; and that omeprazole is a very safe and effective drug [64].

In current Canadian law, a patentee will be held to every “promise” made in the specification, though failure to meet a goal, or “a hoped-for advantage of the invention,” will not invalidate the patent. Rennie summarized the difference between a promise and a goal as follows [117, his emphasis]:

In sum, promises are explicit and define guaranteed or anticipated results from the patent (depending on whether the promise is demonstrated or soundly predicted), whereas goals merely relate to potential uses for the patent.

There was considerable dispute over exactly how to characterize the putative promises, and of course over whether the statements in question were actually promises or merely goals, but in the end, Rennie J held that two promises were made respecting the claimed invention, namely

(1) that it was useful as use as a proton pump inhibitor (PPI); and

(2) that it had an improved therapeutic profile such as a lower degree of interindividual variation [214].

He held that the first promise was met [165], while the second was not [195], [214], and consequently the patent is invalid for lack of utility. (AstraZeneca argued that the second promise was, at most, of improved therapeutic profile, but that truncated promise would not have altered the outcome, as it was not met either [198].) Note that the promise (1), use as a PPI, is the same utility as omeprazole itself. Therefore it is clear that the claimed compound, high-purity esomeprazole, has sufficient utility to support a valid patent, and the patent was invalid solely because of the failure to meet the higher utility that was promised in the patent. Moreover, the elevated promise of improved therapeutic profile was found solely in the disclosure; the claims themselves were to the compound, with no mention of its properties or advantages. This case is therefore a clear example of the promise doctrine in action.

The second promise, which was determinative of invalidity, turned entirely on the interpretation of the following passage from the ‘653 patent [113, Rennie J’s emphasis]:

It is desirable to obtain compounds with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation. The present invention provides such compounds, which are novel salts of single enantiomers of omeprazole.

Ultimately, Rennie J’s conclusion that this passage promised an improved therapeutic profile turned on the word “will” [119-20]. By way of contrast with this imperative language, he noted that in another case he found that “an object a clause beginning with ‘it is a particular object of the present invention to,’ merely described a goal that the patent strived to achieve” [117]. As another example of language indicating a mere goal, “[h]ad the patent stated that such compounds 'may' or 'could' give an improved therapeutic profile, then the argument that such statements referred merely to a goal would be more compelling” [120].

If we accept the premise of the promise doctrine, that patentees intend to make promises of utility in the disclosure which will determine the validity of the patent, then Rennie J’s conclusion that the word “will” signifies a promise strikes me as sound as a matter of textual interpretation, and as being consistent with prior cases. As noted, while the FCA held that a promise must be explicit in its Plavix 2013 FCA 186, blogged here, it also clearly re-affirmed that if a promise is explicit, the patentee will be held to it. Since no patent ever says “I promise [heightened utility]," it is not surprising that affirmative language such as “will” is taken as a sufficiently explicit promise.

Of course, in my view it is wrong to suppose that a patentee ever intended to make promise in the disclosure, which is intended to disclose the invention, not define it: see my article “The False Doctrine of False Promise,” (2013) 29 CIPR 3 (draft version available here). But until the SCC addresses this doctrine, perhaps in the upcoming Plavix case, Apotex / esomeprazole illustrates a fairly straightforward application of the current state of the law relating to the promise of the patent.

To conclude, I should mention a couple of preliminary issues. One was the standing of AstraZeneca Canada, which Apotex challenged because there is no express license agreement between AstraZeneca Aktiebolag, the patentee, and AstraZeneca Canada, which distributed and sold NEXIUM in Canada [9-10]. Rennie J held that standing may be based on an implied licence [10], and that can probably be established solely by the fact that the patentee and the purported licensee are both joined before the court seeking recovery for infringement [11]. In any event, an implied licence may certainly be inferred from the conduct of the parties, and the facts in this case clearly allowed such an inference [23]. This holding strikes me as a straightforward application of Apotex Inc v Wellcome Foundation Ltd, [2001] 1 FC 495 (FCA), which had similar facts.

Rennie J also held that while an NOC proceeding is not res judicata in respect of a subsequent infringement action, which is well established, the doctrines of issue estoppel and abuse of process remain open [30]. However, on the facts he held that it was not an abuse of process for AstraZeneca to shift its argument relating to the promise of the patent between the NOC litigation and the infringement action [41]. Nor, while he found it “more problematic” [46], was AstraZeneca’s changed position regarding the moitivation of a skilled person to separate the enantiomers. On the whole, it seems that while issue estoppel and abuse of process remain open, they will not be lightly invoked to constrain a patentee from changing its litigation strategy between the NOC proceeding and the infringement action.

Finally, I’m a bit late with this post, as I had an enforced long weekend, after storm Arthur left me (and most of Fredericton, NB) without power for three days.