The term “promise” has been used in Canadian patent law for many decades, and has an even longer pedigree in U.K. patent law.1 In modern terms, “promise” is no more than a short hand reference to what a purposive construction of the patent, performed with a view to determining how a skilled reader will understand it, reveals to be the asserted utility of the invention. When understood in this light, the so-called “promise doctrine” simply does not exist.
This paper will demonstrate that different jurisdictions, including the United States and Europe, take different approaches to utility while maintaining a form of a “promise” requirement when the law is viewed as a whole. There are sound policy reasons for holding inventors to the promises made in patent applications, the foremost of which is to ensure that patent monopolies are not given to inventors without a public benefit having been provided in exchange.
In Canada, inventions must be useful, novel and non-obvious in order to receive patent protection.2 There are few legal requirements for utility; an invention must perform some useful function, and it has been held that, in certain circumstances, a scintilla of utility may be sufficient.3 I use the word “may” deliberately because, despite the frequently heard argument, it is simply not the case that a “mere scintilla” of utility will suffice in every situation, for every patent. A “scintilla of utility” is a necessary, but not always a sufficient, condition of utility.4
While an inventor is not required to make a statement or “promise” of utility in his or her patent, if the inventor chooses to do so, he or she will be held to that promise. That is, a “promised utility” is no more than a reference to what the patent states to be the “utility” required by s. 2 of the Patent Act. Where the inventor chooses (or is compelled)5 to assert a utility that goes beyond a “mere scintilla,” the patentee will be held to establishing that utility, through demonstration or sound prediction as of the Canadian filing date and in the usual way.
Recent jurisprudence from the Federal Court of Appeal tells us that it is only where a patent makes an explicit promise that utility will be measured against it. In overturning a trial level decision that had invalidated a patent, the Federal Court of Appeal held that the trial judge had “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.”7 The Court expressly cautioned against construing a patent on the basis of inferences drawn from the language used.
As noted, whether an inventor has promised a specific utility for his or her invention is determined through a purposive construction of the patent specification. It is well-settled that Courts are to employ “purposive construction” to determine the meaning of the patent specification.8 “Rejection of ‘purposeful construction’ would imply the embrace of a purposeless approach that ignores the context and use to which the words are being put.”9 Arguments that employing “purposive construction” undermines the public notice function of patents were canvassed and rejected by the Supreme Court over a decade ago.10
In reality, the construction of documents is central to many legal disputes. Principles have been established to guide this exercise, whether the document in question is a contract, an insurance policy, a statute, a regulation or, indeed, a patent. There is nothing inherently unpredictable or unfair about this approach and no uncertainty arises – it is simply what courts are called upon to do, time and again.
Not everyone agrees. For example, Eli Lilly (“Lilly”) has attacked the “promise of the patent” concept before the Supreme Court of Canada (“SCC”)11 and in a challenge under Chapter 11 of the North American Free Trade Agreement.12 Lilly argues that the concept is a recently created “doctrine” and inconsistent with patent laws of other jurisdictions.
Contrary to these assertions, the concept underlying the use of the term “promise” has been consistently applied in Canadian patent law, for many decades. There has been no recent shift and there is no uncertainty or lack of predictability associated with the use of this term.
OLANZAPINE LITIGATION(ELI LILLY CANADA INC.V.NOVOPHARM LIMITED)
In the olanzapine litigation, Lilly advanced the “promise” debate at the Supreme Court of Canada. A brief discussion of this litigation demonstrates how the “promise” issue has been framed and what the Supreme Court’s attitude towards the notion of “promise doctrine” may in fact be. It was in Lilly’s application for leave to appeal leave to appeal to the Supreme Court of Canada in the olanzapine litigation that the so-called “doctrine” of the “promise of the patent” was first asserted. There, Lilly asserted that it was a recently created doctrine and one which is offside the law of utility applied by Canada’s major trading partners.13
By way of background, Lilly commenced an action for patent infringement against Novopharm in 2007, asserting that Novopharm had infringed the ‘113 Patent in bringing its olanzapine product to market. The ‘113 Patent was a selection patent, specifically claiming the compound olanzapine, an atypical antipsychotic. The ‘113 Patent had been preceded by the ‘687 Patent (filed 15 years before the ‘113 Patent) for the class to which olanzapine belonged. Olanzapine was found to be one of the “most preferred members” of that earlier patent.14 The ‘113 Patent was issued on the basis of statements of advantages made in the patent specification, which sought to elevate olanzapine above the prior class. These statements became the focus of the case.
Ultimately, the trial judge held that there was nothing to justify Lilly’s second monopoly on olanzapine.15 He examined the facts and expert opinion and determined that no advantages had been demonstrated or soundly predicted over the members of the previously patented ‘687 Patent class or even other known antipsychotics.16 This conclusion was ultimately upheld by the Federal Court of Appeal.17 Leave to appeal to the Supreme Court of Canada was sought in late 2012 but denied in May 2013 following an oral hearing.18 As noted, it was in Lilly’s 2012 leave application that it first used the term “promise doctrine,” arguing that this allegedly new doctrine had introduced a lack of predictability and uncertainty into Canadian patent law.
Lilly also argued that the Supreme Court should take steps to harmonize Canada’s patent laws (at least on the issue of promised utility) with those Lilly asserted as being in force in other jurisdictions. Lilly offered no cogent explanation as to why this should occur and failed to specify with which jurisdiction harmonization ought to be attempted (as jurisdictions cited by Lilly, the U.S. and Europe, were not harmonized with one another). However, as I discuss below, there are no international treaties or agreements requiring or even contemplating patent law harmonization. Patent laws and procedure vary in every jurisdiction and different results are often reached in different jurisdictions for many reasons.19 For example, the Supreme Court of Canada reached a different result in the Teva Viagra case on different grounds than the United States and the United Kingdom.20
Although the Supreme Court does not issue reasons on applications for leave to appeal, this application was heard orally and the panel hearing it did not explicitly consider the “promise doctrine” argument during the course of the hearing.21 Justice Cromwell appeared to be interested in whether this (and other issues) had been raised in the Courts below. Justice Moldaver appeared to be interested in the evidentiary standard to be applied to utility. Justice Rothstein asked several questions about whether this was a good case to examine whether after-acquired evidence was appropriate to consider in the context of sound prediction. The promise issue was not a focal point of the Court’s questions.
PROMISE OF THE PATENT IN CANADIAN PATENT LAW
The so-called “promise of the patent” is not new. Courts have long construed patents purposively to determine what the inventor has said is the nature of the invention and its utility.22 In Whirlpool, the Supreme Court observed as follows:23
While “purposive construction” is a label introduced into claims construction by Catnic, supra, the approach itself is quite consistent, in my view, with what was said by Dickson J. the previous year in Consolboard, supra, on the topic of claims construction, at pp. 520-21:
We must look to the whole of the disclosure and the claims to ascertain the nature of the invention and methods of its performance, (Noranda Mines Limited v. Minerals Separation North American Corporation,  S.C.R. 36), being neither benevolent nor harsh, but rather seeking a construction which is reasonable and fair to both patentee and public. There is no occasion for being too astute or technical in the matter of objections to either title or specification for, as Duff C.J.C. said, giving the judgment of the Court in Western Electric Company, Incorporated, and Northern Electric Company v. Baldwin International Radio of Canada,  S.C.R. 570, at p. 574, “where the language of the specification, upon a reasonable view of it, can be so read as to afford the inventor protection for that which he has actually in good faith invented, the court, as a rule, will endeavor to give effect to that construction”.
Not only is “purposive construction” consistent with these well-established principles, it advances Dickson J.’s objective of an interpretation of the patent claims that “is reasonable and fair to both patentee and public.”
Construing the patent involves reading the patent as a whole to determine what the patentee asserts to be the nature of the invention and what he or she has said that it will do – the promised utility. The language used, of course, is of the patentee’s own choosing and, accordingly, there can be no inherent unfairness in holding the patentee to what he or she has chosen to say.24 There is a long history of case law indicating that the stated utility of an invention is determined by reference to what is found in both the claims and the disclosure.25
- Hatmaker v Joseph Nathan & Co.26
- Mullard Radio Valve Company Ltd. v. Philco Radio and Television Corporation of Great Britain Ltd. et al.27
- Wandscheer v. Sicard Ltd.28 – where a majority of the SCC held that the invention in question had no utility because it “could not serve the purposes mentioned in the patent.”
- Metalliflex Ltd. v. Rodi & Wienenberger29
- Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd.30
To establish a lack of utility, the Supreme Court has stressed that it must be shown “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.”31
“SKILLED READER” CONSIDERATIONS
It is trite law that patents are to be construed purposively through the eyes of a skilled reader or “person skilled in the art.”32 The patent, including any statement(s) of utility, is to be interpreted in light of the science and information available at the time of filing.33 This has important implications in the context of construing every aspect of the patent specification, including the promise (if any).
For example, in Eli Lilly & Company v. Teva Canada Limited (“Atomoxetine”), the characteristics of the skilled person were a key factor in the interpretation of the patent. The Court determined that the skilled reader included psychiatrists and pediatricians and held the words “treatment of ADHD,” as found in the specification, to mean a promise to relieve the symptoms of the disorder in some patients to a “clinically meaningful extent.”34 Thus, the identity of the skilled reader can have a large effect on the how the patent is interpreted and, equally, on the scope of the promise.
SELECTION PATENT CONSIDERATIONS
A selection patent is a patent for a compound or group of compounds from a larger class of compounds that were previously described in the prior art or in a prior genus patent. The Supreme Court has held that the invention in a pharmaceutical selection patent is the compound together with its advantages as the “inventor selects only a bit of the subject matter of the original genus patent because that bit does something better than and different from what was claimed in the genus patent.”
For selection patents, the nature of the characteristics alleged to be possessed by the selected compound or group of compounds for which the inventor claims a new monopoly must be clearly defined in the specification.36
It follows from this that the advantages upon which the patentee relies to establish the selection must be promised, in the sense that they must form part of what the purported invention will do. This was the conclusion reached by the Federal Court of Appeal in Olanzapine FCA.37 Patentees who assert advantageous properties in a selection patent specification must be prepared to show that those properties were known or soundly predicted as at the date of filing, in addition to showing that those properties were new and unobvious. Were it otherwise, selection patent monopolies (which by their nature are second monopolies) would be available on the basis of unchallengeable speculation and not “purchased with the hard coinage of new, ingenious, useful and unobvious disclosures”.38
INTERNATIONAL DISCORD ON THE LAW OF UTILITY 39
Under Article 27.1 of the Agreement on Trade-Related Aspects of Intellectual Property Rights, every country must require some form of novelty, inventive step and industrial applicability (utility) prior to providing a patent monopoly for an invention.40 However, there are no substantive rules or international standards governing specifically what is required.41 Signatories to the TRIPs Agreement are free to determine their preferred method of implementing standards for novelty, inventive step and industrial applicability (utility) within their own legal systems.42 Additionally, attempts to harmonize patent laws globally have proved unsuccessful. This is best evidenced by the failure of negotiations surrounding the Substantive Patent Law Treaty,43 where the project was shelved in 2006, after numerous efforts over several years. Despite this, both the American and European patent schemes approach utility in a similar manner to the Canadian system, and the patent laws of Australia and New Zealand explicitly consider what the patentee has said regarding the promised utility of the invention.
In the United States, there is no explicit “promise of the patent” concept. However, the American approach to utility has similarities to Canadian law. U.S. courts define utility by reference to the intended purpose and objective of the invention, which is comparable to the Canadian concept of the promise of a patent.44 Additionally, enablement fulfills many of the same functions as Canada’s utility requirement. Enablement is made out when “the specification of a patent teaches those skilled in the art how to make and use the full scope of the claimed invention.”45 Inventions that would be attacked for lack of utility in Canada can be argued as invalid for lack of enablement in the U.S. This is because an invention that does not work as intended cannot fulfill the enablement requirement.
In contrast to Canada, however, the U.S. takes a divided approach to utility, where both utility and operability are considered.46 Utility requires an invention to have a use and operability requires that it is able to achieve its asserted utility. The asserted utility must be specific and substantial enough to meet the statutory requirement.47 There is a low standard for operability, as inventions will be deemed inoperative only if they are “totally incapable of achieving a useful result.”48
The European Patent Convention (EPC) requires that all patentable inventions be “susceptible of industrial application,”49 meaning that they “can be made or used in any kind of industry, including agriculture.”50 Although this standard is lower than the Canadian standard of utility, patents whose promises are not credible or are based purely on speculation as of the filing date will nonetheless be rejected as not having industrial application.51
Ultimately, the patent laws of the U.S. and Europe differ from each and each differs from Canada. Even if harmonization on an isolated aspect of the law was desirable (or, indeed, a reasonable or plausible goal), it is an open question as to with which jurisdiction Canadian laws ought to be harmonized.
As mentioned, the patent laws of Australia and New Zealand explicitly consider what the patentee has said regarding the promised utility of the invention.52 This follows from their (and Canada’s) historical reliance on the law of the United Kingdom prior to 1977, when the U.K. revised its patent law in an effort to comply with the EPC. Whether similar arguments are being raised in Australia or New Zealand is unknown. The fact that those jurisdictions, with their similar legal traditions, apply a similar approach (which again differs from those of the U.S. and Europe) answers many of the under-informed criticisms of Canada’s place on the international stage on this issue.
There are policy reasons why courts should continue to enforce promises made by patentees. These include, but are not limited to, preventing double patenting or “evergreening” and holding patentees to account for the benefit promised in exchange for the monopoly granted.53
Selection patents, for example, can be abused so as to allow a broad patent covering a compound to be followed many years later by a narrow patent on that compound, all in order to “evergreen” and extend the monopoly granted. Selection patents must promise that a substantial advantage will be secured or substantial disadvantage will be avoided by using the selected compounds relative to the larger class described in the prior genus patent.54 All members of the selected class are required to possess the asserted advantage and nearly none of the remaining class of compounds may possess that advantage.55 If this were not the case, patentees could obtain monopolies for inventions that were no different than the prior art.
It is essential that the patent monopoly given to the inventor be justified. It is a long-standing principle of patent law that a monopoly will only be granted in exchange for full, fair and frank public disclosure. Enforcing the promise of the patent plays a key role in that regard because it ensures that the quid pro quo promised in exchange for the statutory monopoly is not empty or speculative. This is an important consideration because patent monopolies are often granted based on the results promised; the promises made can often assist patentees in overcoming challenges during patent prosecution. If there were no consequences for the making of unfounded promises, monopolies would be given where no public benefit is secured.
Further, as a matter of policy, it is critical that patents contain only truthful and accurate statements, including all statements of utility. On the bargain theory underpinning the entire patent system, patents that contain material, inaccurate statements (including those that may have impacted the issuance of the patent or the benefit promised to the public) ought to be held invalid, regardless of the patentee’s state of mind. Patents obtained on the basis of misinformation are to be eschewed.56
Courts construe patents purposively and as a part of this exercise, they determine what, if anything, the patentee has said about the utility of the described invention. This is sometimes referred to as the “promise of the patent,” but that phrase neither adds to nor detracts from the larger goal of determining the nature of the invention and what the patentee has said it will do. When patentees assert that an invention will do a particular thing, they will be held to those statements. There is no uncertainty or lack of predictability in this, any more than there is in the routine construction of legal documents in which the Courts are constantly engaged.
There is no international instrument or norm which mandates harmonization on substantive patent law. Member states of the World Trade Organization are free to determine their preferred method of implementing the TRIPs requirements for novelty, inventive step and industrial applicability (utility). Attempts to harmonize patent laws have proved unsuccessful and no agreements have been reached in that regard. Simply put, there is no foundation for the argument that Canada should harmonize its patent laws (or a part of them) with those of any other jurisdiction. In any event, that task would be impossible, given that those jurisdictions are, themselves, not harmonized with one another.