Among the most famous inventions for which patent protection has ever been sought are the mousetrap, the lightbulb, the telephone, Aspirin, the compact disk, the recombinant DNA method, the viagra pill and the Covid-19 vaccine. Any new, inventive and useful process or product, in any field of activity, is in principle eligible for protection – or, as the U.S. Supreme Court once uttered: ‘anything under the sun that is made by man is patentable‘.  Few inventions come about as a strike of genius. Many more are the result of huge investments in research and development (R&D), representing immense amounts of money, time and expertise. Patent protection is meant to stimulate innovation by allowing owners to recoup R&D investment and turn a profit on their invention. But no empirical evidence convincingly establishes that the patent system generally achieves this goal. Only in specific sectors of industry, like in the pharmaceutical industry, do patents play a clear role in further development. In most sectors, the case for patent protection is inconclusive at best. Paradoxically, the number of patent applications filed in a country is often seen as a proxy for innovation and growth. Nevertheless, the patent system is credited for encouraging the dissemination of knowledge and information to the public through publication of patent applications and granted patents. So, while patent protection has benefits, it also carries drawbacks: for, even if the patent system acts as a stimulus for innovation, the exclusivity it confers leads almost by definition to high(er) consumer prices and limited access to inventions – think of drugs or vaccines, for example. Moreover, powerful corporations are known to use their patent portfolios as a strategic tool to block competitors from coming too close. To reduce such rent seeking behaviour by corporations, it is paramount that the requirements for protection be strictly applied, so as avoid rewarding trivial inventions, also known as ‘patent trolls’.

1. Legislative history

The origin of Canada’s patent legislation can be traced all the way back to the British Statute of Monopolies of 1623. The Statute of Monopolies declared all monopolies illegal and void save only those few specifically excepted from its operation. This Act was never officially repealed and some commentators believe that it became part of the law of Canada at the time of the Treaty of Paris. Although the philosophical underpinnings of the systems in force in Great Britain and on the North American continent eventually diverged, both systems share a common source in the common law of England as expressed in the Statute of Monopolies. The case law of Great Britain has been accepted as authoritative in interpreting the patent law of Canada, save where the statutory provisions of the two countries have diverged.

2. Objectives of the patent system

Patent protection pursues a clear utilitarian objective, e.g. stimulating the creation and development of new technologies (Vaver 2011, p. 300). Of all IP rights, patent rights afford the strongest protection to their owner.  As incentive to produce new inventions, patent owners obtain the right to manufacture, import and use the patented invention to the exclusion of all others, including even those who have developed a similar invention independently from the patent owner.

As the Supreme Court emphasised in the landmark case Teva v Pfizer (2012 SCC 60, para. 32), ‘[t]he patent system is based on a “bargain”, or quid pro quo:  the inventor is granted exclusive rights in a new and useful invention for a limited period in exchange for disclosure of the invention so that society can benefit from this knowledge. This is the basic policy rationale underlying the Act. The patent bargain encourages innovation and advances science and technology.’ The bargain between the State and the inventor requires that patent owners disclose their invention through what is known as a Specification. Provided that the inventors publish their “invention in such a form and in such a way as to enable the public to get the benefit of it, they obtain a monopoly of that invention for a period of [twenty] years. That is the bargain.”  (Tubes, Ld. v. Perfecta Seamless Steel Tube Company, Ld. (1902), 20 R.P.C. 77, at pp. 95-96)

The patent protection is a hard bargain, however. The Supreme Court stressed that “[a] patent is not intended as an accolade or civic award for ingenuity. It is a method by which inventive solutions to practical problems are coaxed into the public domain by the promise of a limited monopoly for a limited time. The public should not be expected to pay an elevated price in exchange for speculation, or for the statement of “any mere scientific principle or abstract theorem” or for the “discovery” of things that already exist, or are obvious” (Apotex v. Wellcome Foundation, 2002 SCC 77). Therefore only specific types of inventions (Section B.), that meet the requirements of protection (Section C.) and that are fully described by their inventor showing how they are produced, built or put into operation (Section D.), are worthy of protection. To make sure that the patent bargain is properly enforced, patent rights are granted following an extensive examination process by the patent examiner at CIPO, as described in section E. below.

The key question is whether the public is getting what it ought to be getting in exchange for exclusive monopoly rights. Patent monopolies are granted to encourage people to make inventions and to disclose their nature and working. Unless a full and fair description is given the patent ought not to be held valid. In the same way, the claims of the invention ought to clearly reveal what the scope of protection is, i.e. what may and may not be done with the invention. If the claims are incomprehensible or ambiguous, or do not really relate to the invention which has been disclosed in the body of the patent specification, the patent again should not stand valid. The scope of patent protection is examined in section F. below. This chapter closes with a short description of the laws relating to pharmaceutical patents.

Not all inventions or discoveries are susceptible of protection under the patent regime. Section 2 of the Patent Act (PA) determines what constitutes the object of patent protection, while section 27(8) defines what is expressly excluded from protection. To be protectable under the Patent Act, not only must an invention fall under one of the categories specified in s.2 PA, but it must also meet the criteria for protection, e.g. it must be novel, useful and non-obvious. These criteria for protection are discussed in section C. below. Interestingly, the definition of ‘invention’ in the Patent Act has remained unmodified since its adoption in 1935, despite the fact that Canada ratified the NAFTA and the TRIPS Agreements. Both international instruments define the patentable subject matter in a more straightforward manner than the Canadian legislation does, saying that an invention is a product or a process in all fields of technology. The same goes for the exclusions to patentability, which are clearly set out in the international agreements, compared to the Canadian legislation. This section examines the types of inventions that qualify as protectable subject matter, and those that do not, under ss.2 and 27(8) PA.

1. Patentable ‘inventions’

The Canadian Parliament chose not to implement s.27 of the TRIPS Agreement, probably judging that the long standing definition of invention in the Patent Act already met the international obligations. The list of categories of inventions in s.2 is exhaustive, which means that if an invention does not qualify either as a useful art, process, machine, manufacture or composition of matter, it will not be patentable. Because the definition of ‘invention’ in the Patent Act is at once detailed and ambiguous, courts have had to construe this statutory provision in the light of the factual situations in front of them. Most ambiguous is the concept of ‘useful art’, but some ‘processes’ and ‘compositions of matter’ can also raise interpretation issues. The question a court will ask is what is the subject matter defined by the claim(s) in the patent application? If the subject matter defined by the claim(s) is neither an art, process, machine, manufacture or composition of matter, or any new and useful improvement thereof, then the application must be refused on the basis of no patentable subject matter, or the patent if previously awarded must be invalidated for the same reason. 

Determining what qualifies as a patentable ‘useful art’ can be challenging, especially knowing that mere scientific principles and abstract theorems are unpatentable. ‘Art’ in this context is a ‘way of doing things’, not an artistic expression. The Exchequer Court once explained that “[a]n art or operation is an act or series of acts performed by some physical agent upon some physical object and producing in such object some change either of character or of condition. It is abstract in that, it is capable of contemplation of the mind. It is concrete in that it consists in the application of physical agents to physical objects and is then apparent to the senses in connection with some tangible object or instrument.” (Lawson v. Commissioner of Patents (1970), 62 C.P.R. 101).

A ‘useful art’ can also consist in a manifestation, effect, or change of character, as long as it is concrete and tangible. In Shell Oil v. Commissioner of Patents (1982 CanLII 207 (SCC)), the Supreme Court accepted the patentability of the new use of known chemical compounds as plant growth regulators. The claimed invention was not the compound itself or its mixture with other compositions, but rather the new use for the existing compounds as plant growth regulators. Wilson J. speaking for the Court accepted the view that nothing in the Patent Act precluded a viable claim for the new use of known compounds as an invention within the meaning of the definition. She defined ‘art’ by referring to the word’s general connotation of ‘learning’ or ‘knowledge’. A new ‘art’ advances knowledge compared to the ‘state of the art’ or the ‘prior art’. The appellant’s ‘art’ consisted in the recognition of the compound’s hitherto unrecognised properties and the development of the method whereby these properties could be realised through practical application.

Implicit in the definition of ‘invention’ is that patentable subject matter must be something with physical existence, or something that manifests a discernible effect or change. It must have a practical application. However, the mere fact that the claimed invention has a practical application is not sufficient in itself to warrant the issuance of a patent. There needs to be a ‘physicality requirement’. The Commissioner’s identification of the actual invention is to be grounded in a purposive construction of the patent claims. Purposive construction ensures that the Commissioner is attuned to the possibility that a patent claim may be expressed in language that is deliberately or inadvertently deceptive. For example, the Commissioner would see through an apparent a claim for an “art” or a “process” which, upon a proper construction, would turn out to be a claim for a mathematical formula and therefore not patentable subject matter (Schlumberger Canada Ltd. v. Canada (Commissioner of Patents), [1982] 1 F.C. 845 (C.A). Whether the claimed invention hints at a physical existence, or manifests a discernible effect or change from a pre-existing situation, is to be determined through a purposive construction of the patent claims. The interpretation of “patent claims though a purposive construction” is a somewhat abstract endeavour that courts often repeat as a mantra without offering further explanation. The challenge for anyone interpreting patent claims, like a patent examiner or a judge, is to objectively determine what the person skilled in the art would, as of the date of publication of the patent application and on the basis of the particular words or phrases used in the claim, have understood the applicant to have intended to be the scope of protection sought for the disclosed invention (see Free World Trust v. Électro Santé Inc., 2000 SCC 66 at paragraph 50). According to established jurisprudence, the proper interpretation of patent claims consists in reaching a balance between a broad or a narrow interpretation, by looking at the reasonable purpose of the invention as described in the claims.

2. Exclusions from Patentable Subject Matter

Section 27(8) PA contains the only statutory exclusion from patentability in the Canadian patent regime. Other limits to patentability have been developed through case law, through the interpretation of the concepts of invention, scientific principles and abstract theorems. The jurisprudential exclusions include business methods, therapeutics methods and higher lifeforms. These exclusions roughly correspond to those listed in subs. 27.2 and 27.3 of the TRIPS Agreement which allows – but does not oblige – countries to provide for certain exclusions from patentability. Canadian patent law does not provide for the possibility to refuse an application on the basis of public order or morality, however, as we will see below in relation to the Monsanto v Schmeiser case.

While the interpretation of the concepts of invention, scientific principles and abstract theorems may give rise to various types of exclusions from patentability, the pages below focus on three main types of exclusion:  1) Mere Ideas, Plans; 2) Methods of medical treatment; and 3) Higher life forms.

Mere Ideas, Plans

Mere ideas, plans, abstract principles are non-patentable subject matter, pursuant to s.27(8) PA. Logically, no one should be granted a monopoly on ideas that have no use or tangible existence or effect. For the same reason, pure discoveries or natural phenomena are also excluded from patent protection. The discovery of penicillin to combat infections, the double helix DNA sequence, or the discovery of a new element in the periodic table are all excluded from patent protection. Everyone must be free to use or build on ideas, plans or abstract principles. The line between a patentable idea having a physical existence or discernible effect and an non-patentable abstract concept is often difficult to draw. Many patent applications are rejected by the Commissioner of Patents on the ground that they seek protection in relation to ‘mere plans’ or ideas.

How does a business method qualify? Or a computer program? Courts have generally held that business methods are not patentable subject matter because they are abstract ideas. The question has arisen in case law whether one should consider that a business method would become patentable subject matter if it has a practical embodiment or a practical application. As we saw in the Amazon.com v Commissioner of Patents case, the Federal Court of Appeal opined that this cannot be a distinguishing test, because it is axiomatic that a business method always has or is intended to have a practical application.

On August 21, 2020, the Federal Court issued its decision in Yves Choueifaty v Attorney General of Canada, 2020 FC 837, granting the appeal from the Commissioner of Patents’ decision that Canadian Patent Application No. 2,635,393 (the ‘393 Application’) entitled “Method and Systems for Provision of an Anti-Benchmark Portfolio” was not patentable subject-matter. The 393 Application claimed an invention of a computer implementation of a new method for selecting and weighing investment portfolio assets that minimises risk without impacting returns. The main issue in the appeal was whether the computer elements referred to in the claims were essential elements. The Court scrutinised and rejected the Commissioner’s approach, and directed the Commissioner to consider the 393 Application afresh in accordance with the Court’s reasons. Most recently, the Commissioner of Patents issued a new decision in which it concluded in favour of patentability by saying:

The subject matter of this case is reminiscent of that in Schlumberger Canada Ltd v Commissioner of Patents, [1982] 1 FC 845 (CA) at 204–06, where the Federal Court of Appeal explained that a mental process of making certain calculations according to certain mathematical formulae is not patentable subject matter, and that merely prescribing the calculations be made by computer cannot transform it into patentable subject matter. The claimed inventions of the second proposed claims can be considered to distinguish from those of Schlumberger, however, in that the computerized calculations here are not merely for yielding information, but for permitting the computer to carry out the portfolio optimization procedures with significantly less processing and greater speed. There was no suggestion in Schlumberger that the invention lay in the computer calculating its results with less processing or greater speed.

Methods of medical treatment

Methods of medical treatment have long been held to be non-patentable subject matter, following the Supreme Court decision in Tennessee Eastman Co. v. Commissioner of Patents [1972 CanLII 167 (SCC)] The method of medical treatment for which a patent was sought concerned a method of closing incisions following surgery by the use of an adhesive substance discovered to have a marked affinity for adhering to living tissue. The Commissioner had refused the patent on the basis that this was not the kind of discovery (the adhesive itself not being new) which fell within the definition of “invention” in the Act. In particular, he found that it was not an “art” because it was useful only in the process of surgical or medical treatment and produced no result in relation to trade, commerce or industry. It was not patentable because it was essentially non-economic and unrelated to trade, industry or commerce. It was related rather to the area of professional skills.

The Supreme Court’s grounds for rejecting the patent application in Tennessee Eastman are not very convincing. Wilke [Prohibiting Medical Method Patents: A Criticism of the Status Quo, (2011) 9:1 CJLT], argues that the ground for refusal to grant a patent in this case were somewhat tenuous, as non-commercial activities do not fit within the statutory definition of “invention”. Instead the Court could perhaps have argued that the invention was not patentable, not because is was non-economic, but because it relied too heavily on the exercise of a physician’s skill and judgment. However, in view of the fact that s. 27(3)(a) of the TRIPS Agreement gives Contracting Parties the possibility to exclude methods of medical treatment from patentability, one could argue that the international legal community accepts that this type of invention may, or should, fall outside the scope of protection. The legal rationale for this consensus appears to be a widely shared public policy concern, where allowing for the grant of patents on methods of medical treatment could increase health care costs or put obstacles in the availability of certain patented methods.

Since the Tennessee Eastman decision, the issue of the patentability of methods of medical or surgical treatment has been examined on occasion. The Federal Court of Appeal recently summarised the state of the law on this point in Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research, [2020 FCA 30], saying that “the Federal Court jurisprudence has developed the principle that a claim to a vendible product, including a substance intended for the treatment of a medical condition, can be good subject matter for a patent claim, but not if the claim encompasses the skill of a medical professional”.

Higher Life Forms

The interpretation of “invention” as given in s.2 PA has always excluded new varieties of plants and seeds. Plants and seeds are considered a unique category of creativity, so much so as to warrant an entirely separate act to govern creative contributions of this kind. These are protected under the Plant Breeder’s Rights Act.

Genetic engineering can occur in two ways.  The first involves crossing different species or varieties by hybridisation, altering the frequency of genes over successive generations.  The main consequence of this intervention is to oppose within the same cell allelic genes, that is, opposing characteristics which replace each other alternately in the hereditary process, as a consequence of the alternate action of their dominant genes.  Naturally, the genes only offer a reasonable prospect that the traits will be acquired from one generation to the next. The second type of genetic engineering, which requires a change in the genetic material — an alteration of the genetic code affecting all the hereditary material — since in the latter case the intervention occurs inside the gene itself.  The change made is thus a molecular one and the “new” gene is thus ultimately the result of a chemical reaction, which will in due course lead to a change in the trait controlled by the gene.  While the first method implies an evolution based strictly on heredity and Mendelian principles, the second also employs a sharp and permanent alteration of hereditary traits by a change in the quality of the genes. The genetic engineering performed by Hi-Bred was of the first type. The intervention made by Hi-Bred did not in any way appear to alter the soybean reproductive process, which occurs in accordance with the laws of nature.  Earlier decisions had never allowed such a method to be the basis for a patent.  Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), 1989 SCC 64.

The qualification of higher life forms as a patentable invention was one of the key issues considered in the landmark decision of the Supreme Court in Harvard College v. Canada (Commissioner of Patents) (2002 SCC 76). The invention in this case aimed to produce animals with a susceptibility to cancer for purposes of animal carcinogenic studies. In its patent application, the respondent sought to protect both the process by which the oncomice are produced and the end product of the process, i.e. the founder mice and the offspring whose cells are affected by the oncogene. The question posed to the Court was whether the definition of invention, and more particularly the words “manufacture” or “composition of matter”, within the context of the Patent Act, encompass higher life forms such as the oncomouse. In a 5-4 split decision, the majority of the Court concluded against a broad interpretation of the concept of invention that would include higher life forms. While Bastarache J., writing for the majority, reiterated that s.40 PA does not allow the Patent Commissioner to refuse a patent on the basis of public policy considerations, it is interesting to note that the sensitivity of the matter lead him to take a restrictive approach to the interpretation of the words “manufacture” and “composition of matter” in the sense of s.2 PA:

“This conclusion is supported by the fact that the patenting of higher life forms raises unique concerns which do not arise in respect of non-living inventions and which are not addressed by the scheme of the Act. Even if a higher life form could, scientifically, be regarded as a “composition of matter”, the scheme of the Act indicates that the patentability of higher life forms was not contemplated by Parliament. Owing to the fact that the patenting of higher life forms is a highly contentious and complex matter that raises serious practical, ethical and environmental concerns that the Act does not contemplate, I conclude that the Commissioner was correct to reject the patent application. This is a policy issue that raises questions of great significance and importance and that would appear to require a dramatic expansion of the traditional patent regime. Absent explicit legislative direction, the Court should not order the Commissioner to grant a patent on a higher life form.”

In view of the reasons invoked by the majority of the Court for their restrictive interpretation, do you think that it would make sense to introduce in the Act the possibility to exclude inventions from patentability on the basis of morality or public order?

https://www.genetargeting.com/transgenic-mice/journey-of-the-oncomouse/

EPILOGUE: on 7 October 2003, Canadian patent 1,341,442 CA 1341442 was granted to Harvard College. The patent was amended to omit the “composition of matter” claims on the transgenic mice. This omission in the claim essentially meant that the patent application no longer claimed the mouse itself, but only the process, or the ‘art’ of genetically altering the genome of a mouse by inserting a cancer-promoting gene.

Once a patent claim is deemed to qualify as a patentable invention in the sense of s.2 PA, it must still meet the three criteria for patentability, e.g. novelty, non-obviousness and usefulness. Whether an invention meets the patentability requirements is the main aspect of the Patent Commissioner’s examination of the patent application. But invoking the lack of novelty, usefulness or inventiveness is also a common defence to a patent infringement claim.  The main difference between raising the patentability criteria at the application stage or in defence to an infringement action lies in the burden of proof: at the application stage, the patent applicant will need to establish that the invention does meet the patentability requirements, while in defence to a patent dispute, the defendant will need to establish that the invention is invalid. The three patentability criteria are assessed by reference either to the claimed invention or to the prior art, e.g. to existing knowledge in the field, from the perspective of the ‘person of ordinary skill in the art’ or POSITA. For this reason, before discussing the notions of novelty, usefulness and non-obviousness, we first explain who the POSITA is.

1. POSITA

The “person with ordinary skill in the art”, or POSITA, is not defined in the Act. It is a fictitious person, identified on a case-by-case basis for the assessment of each invention. The determination of the relevant POSITA will need to occur with respect to at least two key events: first, when the Commissioner of Patents examines the application, including in subsequent proceedings, should the patent application have been rejected; and second, when the patentee enforces their rights against an alleged infringer. Grasping the necessary and relevant characteristics of the POSITA is essential since the patentability of the invention is seen through this person’s eyes. The implications of the determination of the POSITA are therefore huge, since the patentability of an invention will depend on the identification of the relevant art, the relevant skills of the person and the common general knowledge (CGK) of that person.

In the context of infringement proceedings, it is not uncommon to see that parties will offer different views on the characteristics of the POSITA, leading of course to different conclusions. Expert witnesses will be presenting the parties’ position referring to their own definition of the relevant POSITA and their characteristics. When parties to a dispute disagree on the characteristics of the POSITA, the judge will make the final determination. The fictitious person sometimes turns out to be a composite person, represented by a team comprising one or more professionals, with a multidisciplinary background. From case law it is clear that the POSITA need not be the inventor. The POSITA is typically unimaginative and uninventive, but reasonably diligent in keeping up with advances (Pfizer Canada Inc v Teva Canada Ltd, 2017 FC 777 at para 185). The POSITA is not incompetent, nor stripped of the ability to pursue reasonable and logical enquiries. The POSITA brings background knowledge and experience to the workbench (AstraZeneca Canada Inc v Apotex Inc, 2015 FC 322 at para 276) and can make deductions based on the information available (Beloit Canada Ltd v Valmet Oy (1986), 8 CPR (3d) 289 at 294 (FCA)).

The “common general knowledge” shared by persons skilled in the art (Free World Trust at para 44) is the knowledge possessed at the relevant time, and includes what the POSITA would reasonably have been expected to know. The CGK must be established with evidence on a balance of probabilities, and cannot be assumed (Uponor AB v Heatlink Group Inc, 2016 FC 320 at para 47). It may include the information presented as background knowledge in the patent itself (Newco Tank Corp v Canada (Attorney General), 2015 FCA 47 at para 10).

The point of view of the POSITA comes into play when reading the claims, in order to evaluate their novelty and utility, and when assessing the non-obvious character of the invention compared to the prior art. When considering the role of the POSITA in respect of disclosure and enablement, the skilled person is “taken to be trying to understand what the author of the description in the prior patent meant.”

2. Novelty

a. Prior Art & Filing Date

The novelty of an invention is assessed in reference to ‘the state of the art’, or ‘prior art’. Prior art is “the collection of learning in the field of the patent at issue” and “comprises any publicly available teaching, however obscure or not generally accepted” (Mylan Pharmaceuticals ULC v Eli Lilly Canada Inc, 2016 FCA 119. ‘Prior art’ is therefore any evidence that someone, somewhere, sometime previously has described or shown or made something that contains a use of technology that is very similar to an applicant’s invention. Anything can be prior art. To find out if an invention is novel, an applicant should not rely on a search for existing products. The primary source of information on prior art is contained in databases of patents and published patent applications, as well as non-patent literature, including magazine articles, newspaper articles, electronic publications, on-line databases, website or Internet publications. A subject matter can also have been made available to the public through an oral presentation at a scientific meeting, a demonstration at a trade show, a lecture or speech, or a statement made on a radio/TV talk show. From this, it is clear that keeping the invention secret is paramount until such time as the patent application is filed. 

Normally an application is entitled to priority as of the date of its filing. In the case of convention applications, however, the applicant requests the recognition of an earlier priority date. This procedure exists in the case of an application for a patent for an invention filed in Canada by any person entitled to protection under the terms of any treaty or convention relating to patents to which Canada is a party.

Pursuant to paragraph 28.2(1) PA, the subject-matter of a patent claim must not have been disclosed before the claim date by a person other than the applicant for the patent (or a person who obtained knowledge from the applicant) in such a manner that the subject matter became available to the public. The “claim date”, which effectively defines a cut-off date for citable prior art, is defined in section 28.1 to be the earlier of the Canadian filing date and the filing date of a previously filed application on which a valid priority claim has been made. One of the requirements for a valid priority claim is that the application claiming priority was filed within twelve months after priority application. In addition, subsection 28.4(4) provides that, where there are two or more previous applications on which priority could be claimed, the twelve months counts from the earliest filing.

With the enactment of para. 27(1)(d) on October 1, 1989, which was replaced by para. 28.2(1)(a) on October 1, 1996, the test for anticipation by any means became disclosure of “the subject-matter defined by a [patent] claim” (the invention) “. . . in such a manner that the subject-matter became available to the public in Canada or elsewhere”. The change to the legislation, inter alia:

1. Reduced the relevant grace period prior to the filing of the patent application;
2. Made disclosure anywhere, and not just in Canada, relevant;
3. Eliminated use or sale of the invention per se as sufficient evidence of anticipation;
4. As proof of anticipation, required disclosure in such a manner that the invention became available to the public in Canada or elsewhere.

b. Anticipation by publication

An invention will be anticipated if a patent application or any other element of prior art describing the invention was available before the filing date anywhere in the world. The prior publication must contain so clear a direction that a skilled person reading and following it would in every case and without possibility of error be led to the claimed invention. Anticipation requires proof of both disclosure and enablement (see section D. below). To affect the novelty of the patent application, the prior patent must disclose subject matter which, if performed, would necessarily result in infringement of that patent.

… anticipation, or lack of novelty, asserts that the invention has been made known to the public prior to the relevant time. The inquiry is directed to the very invention in suit and not, as in the case of obviousness, to the state of the art and to common general knowledge. Also, as appears from the passage of the statute quoted above, anticipation must be found in a specific patent or other published document; it is not enough to pick bits and pieces from a variety of prior publications and to meld them together so as to come up with the claimed invention. One must, in effect, be able to look at a prior, single publication and find in it all the information which, for practical purposes, is needed to produce the claimed invention without the exercise of any inventive skill. The prior publication must contain so clear a direction that a skilled person reading and following it would in every case and without the possibility of error be led to the claimed invention. (Beloit Canada Ltd. v. Valmet OY (1986), 8 C.P.R. (3d) 289 (F.C.A.), per Hugessen J.A., at p. 299)

In Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 (para. 37), the Supreme Court retained the following non-exhaustive factors to be considered in accordance with the evidence in each case.

1. Enablement is to be assessed having regard to the prior patent as a whole including the specification and the claims. There is no reason to limit what the skilled person may consider in the prior patent in order to discover how to perform or make the invention of the subsequent patent. The entire prior patent constitutes prior art.
2. The skilled person may use his or her common general knowledge to supplement information contained in the prior patent. Common general knowledge means knowledge generally known by persons skilled in the relevant art at the relevant time.
3. The prior patent must provide enough information to allow the subsequently claimed invention to be performed without undue burden. When considering whether there is undue burden, the nature of the invention must be taken into account. For example, if the invention takes place in a field of technology in which trials and experiments are generally carried out, the threshold for undue burden will tend to be higher than in circumstances in which less effort is normal. If inventive steps are required, the prior art will not be considered as enabling. However, routine trials are acceptable and would not be considered undue burden. But experiments or trials and errors are not to be prolonged even in fields of technology in which trials and experiments are generally carried out. No time limits on exercises of energy can be laid down; however, prolonged or arduous trial and error would not be considered routine.
4. Obvious errors or omissions in the prior patent will not prevent enablement if reasonable skill and knowledge in the art could readily correct the error or find what was omitted.

c. Anticipation by use or sale

Most instances of anticipation affecting the novelty of a patent application take place through publication. But anticipation can also occur through prior use or sale of the subject matter so as to have become available to the public in Canada or elsewhere. When faced with a case of anticipation by disclosure through prior use or sale under para. 28.2(1)(a), the Court must have regard to the circumstances of prior use or sale, in order to determine how a person skilled in the art might be led, without error, to the invention claimed. The main case on this point is the Federal Court of Appeal’s decision in Canwell Enviro-Industries Ltd v Baker Petrolite [2002 FCA 158]. Relying on English jurisprudence, the Federal Court of Appeal drew eight, non-exhaustive, principles to help determine whether a subject matter has been disclosed in a manner that would destroy the novelty of an invention:

1. Sale to the public or use by the public alone is insufficient to prove anticipation. Disclosure of the invention is required to constitute anticipation under para. 28.2(1)(a).

2. For a prior sale or use to anticipate an invention, it must amount to “enabling disclosure”.

3. The prior sale or use of a [chemical] product will constitute enabling disclosure to the public if its composition can be discovered through analysis of the product.

4. The analysis must be able to be performed by a person skilled in the art in accordance with known analytical techniques available at the relevant time. The person skilled in the art, using available analytical techniques, must be able to find the invention without the exercise of inventive skill.

5. In the context of patent anticipation under para. 28.2(1)(a), when reverse engineering is necessary and capable of discovering the invention, an invention becomes available to the public if a product containing the invention is sold to any member of the public who is free to use it as she or he pleases.

6. It is not necessary to demonstrate that a member of the public actually analyzed the product that was sold.

7. The amount of time and work involved in conducting the analysis is not determinative of whether a skilled person could discover the invention. The relevant consideration, in this respect, is only whether inventive skill was required.

8. It is not necessary that the product that is the subject of the analysis be capable of exact reproduction. It is the subject matter of the patent claims (the invention) that must be disclosed through the analysis. Novelty of the claimed invention is destroyed if there is disclosure of an embodiment which falls within the claim.

3. Utility or Usefulness

The Patent Act defines an “invention” as, amongst other criteria, “new and useful” (s.2). The utility requirement serves a clear purpose. To avoid granting patents prematurely, and thereby limiting potentially useful research and development by others, the case law has imposed a requirement that an invention’s usefulness be demonstrated or soundly predicted at the time of application, rather than at some later point. This ensures patents are not granted where the use of the invention is speculative. What matters is that an invention “be useful, in the sense that it carries out some useful known objective” and is not merely a “laboratory curiosity whose only possible claim to utility is as a starting material for further research”. The application of the utility requirement in s.2, therefore, is to be interpreted in line with its purpose — to prevent the patenting of fanciful, speculative or inoperable inventions.

A policy of patent first and litigate later would unfairly put the onus of proof of utility on the attackers to prove invalidity, without the patent owner’s ever being put in a position to establish validity. If an invention is not useful, it is not an invention within the meaning of the Act. Utility generally means useful for the purpose claimed, not commercial acceptance. If the invention does not work, then it is not useful, and therefore not patentable. The invention must be useful as of the date of the claim or as of the time of filing. Unless the inventor is in a position to establish utility as of the time the patent is applied for, on the basis of either demonstration or sound prediction, the Commissioner by law is required to refuse the patent (s.40 PA). If a patent sought for is based on the doctrine of sound prediction and is subsequently challenged, the challenge will succeed if the prediction at the date of application was not sound, or, irrespective of the soundness of the prediction, “[t]here is evidence of lack of utility in respect of some of the area covered”. All that is required to meet the utility requirement in s.2 is that the invention described in the patent do what the patent says it will do, that is, that the promise of the invention be fulfilled. Utility is a disclosure requirement, which can be demonstrated by conducting tests. But utility is not a separate requirement for the disclosure.

The concept of ‘sound prediction’ becomes relevant only when an invention’s utility cannot actually be demonstrated by way of tests or experiments, but can nevertheless be successfully predicted. The doctrine of  sound prediction balances the public interest in early disclosure of new and useful inventions, even before their utility has been verified by tests (which in the case of pharmaceutical products may take years) and the public interest in avoiding cluttering the public domain with useless patents, and granting monopoly rights in exchange for misinformation.

The main teachings on the sound prediction doctrine flow from the Supreme Court’s decision in Apotex v Wellcome Foundation, [2002] 4 SCR 153. This case concerned the Wellcome Foundation’s patent application for the use of the drug AZT as a treatment for HIV/AIDS. The doctrine of sound prediction has three components:

1. There must be a factual basis for the prediction;
2. The inventor must have at the date of the patent application an articulable and “sound” line of reasoning from which the desired result can be inferred from the factual basis;
3. There must be proper disclosure. Normally, it is sufficient if the specification provides a full, clear and exact description of the nature of the invention and the manner in which it can be practised

The soundness of the prediction is a question of fact. It is an established principle that a patent cannot be refused because an inventor has not fully tested and proved it in all its claimed applications. Only if the inventors have claimed more than what they have invented and included substances which are devoid of utility should the claims be open to attack. Cabot Corp v. 318602 Ontario Ltd., (1988) 20 C.P.R. (3d) 132 (FC Trial Division).

It is worth highlighting the Supreme Court’s firm rejection, in AstraZeneca Canada Inc. v Apotex Inc. [2017 SCC 36], of the “promise of the patent doctrine”.  This doctrine had emerged in the case law of the Federal Court in relation to the requirement of utility. The “promise of the patent” doctrine held that if a patent application promised a specific utility, only if that promise is fulfilled, can the invention have the requisite utility. The Promise Doctrine required the identification of promises based on a review of the entire specification, i.e. both the claims and the disclosure. This approach was contrary to the normal analysis conducted when dealing with issues of validity, such as novelty or non-obviousness. While the analysis should focus on the claims alone, and only consider the disclosure where there is ambiguity in the claims, the Promise Doctrine directed courts to read both the claims and the disclosure to identify potential promises, rather than the claims alone, even in an absence of ambiguity in the claims. Once the ‘promises of the patent’ had been identified, the requirement of usefulness was fulfilled under the doctrine only if all of the promises were met either by demonstration or sound prediction. If not all promises were fulfilled, the patent, in its entirety, was invalid. Speaking for the Court, Rowe J. ruled that the Promise Doctrine ran counter to the scheme of the Act and was therefore unsound.

To require that all multiple uses be met for the patent’s validity to be upheld could lead to unfair consequences. It risks depriving an otherwise useful invention of patent protection because not every promised use was sufficiently demonstrated or soundly predicted by the filing date. Such a consequence would be punitive and be devoid of basis in the Act. Furthermore, such a consequence would be antagonistic to the bargain on which patent law is based wherein inventors must give fulsome disclosure in exchange for a limited monopoly (British United Shoe Machinery Co. v. A. Fussell & Sons Ltd. (1908), 25 R.P.C. 631 (C.A.), at p. 650).

The correct approach to utility consists in discerning the subject-matter of the invention through a purposive claims construction. Rowe J. specified that the scope of potentially acceptable uses to meet the s.2 requirement is limited — not any use will do. By requiring the usefulness of the proposed invention to be related to the nature of the subject-matter, a proposed invention cannot be saved by an entirely unrelated use. For example, it is not sufficient for an inventor seeking a patent for a machine to assert it is useful as a paperweight. To determine whether a patent discloses an invention with sufficient utility, courts should first identify the subject-matter of the invention as claimed in the patent, then ask whether that subject-matter is capable of a practical purpose (i.e. an actual result). The Act does not prescribe the degree or quantum of usefulness required, or that every potential use be realized — a scintilla of utility will do. A single use related to the nature of the subject-matter is sufficient, and the utility must be established by either demonstration or sound prediction as of the filing date.

4. Non-Obviousness

The recognition and application of the doctrine of non-obviousness, also known as the criterion of inventiveness, ensures that no patent is granted with respect to trivial advancements over the prior art (see M. Herder, “Demythologizing PHOSITA — Applying the Non-Obviousness Requirement under Canadian Patent Law to Keep Knowledge in the Public Domain and Foster Innovation” Osgoode Hall Law Journal 47.4 (2009) : 695-750). The question to be asked is whether the POSITA would, in the light of the state of the art and of common general knowledge as at the claimed date of invention, have come directly and without difficulty to the solution taught by the patent. If the inventor reached the invention quickly, easily, directly and relatively inexpensively, in light of the prior art and common general knowledge, that may be evidence supporting a finding of obviousness, unless the level at which they worked and their knowledge base was above what should be attributed to the skilled person. Their course of conduct would suggest that a skilled person, using their common general knowledge and the prior art, would have acted similarly and come up with the same result. Determination of the (non)obvious character of an invention is a matter of fact.

In Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61, the Supreme Court adopted the British Court of Appeal’s four-step approach for the obviousness inquiry outlined by Oliver L.J. in Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59 (C.A.).

(1)   (a) Identify the notional “person skilled in the art”;

(b)  Identify the relevant common general knowledge of that person;

(2)  Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;

(3)  Identify what, if any, differences exist between the matter cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed;

(4)  Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?

The obviousness inquiry should be undertaken on a claim-by-claim basis (Zero Spill Systems (International) Inc v Heide, 2015 FCA 115 at para 85). If an independent claim is found to not be obvious, then dependent claims therefrom cannot be obvious. In contrast, if an independent claim is held to be obvious, the Court must go on to consider each dependent claim for obviousness.

The Patent Act requires at s.27 that a specification, including claims, be filed with the application. The claims determine the scope of protection on the invention once the patent is issued, while the specification is meant to fulfil the disclosure requirement. This requirement goes to the essence of the ‘patent bargain’: the inventor is granted, for a limited time, the exclusive right to exploit their invention. In return, the inventor must disclose the invention to the public so that when the term of the patent expires, the invention may be exploited by anyone.” If a person skilled in the art can arrive at the same results only through chance or further long experiments, the disclosure is insufficient and the patent is void. Note that the Commissioner has no discretion, under s.40 PA, to refuse a patent that meets the legal requirements.

1. Claims

When discussing the relationship between the specification and the claims in a patent, the first task in any patent action is to decide exactly what monopoly the patentee has been granted. Today all patents end with claims. The function of the claims is to define the monopoly. The patent, if valid, enables the patentee to stop other people making anything covered by, or using any process covered by, his claims during the life of the patent. One of the important features of the claims is to make it clear to other people what they are not entitled to do during the life of the patent, and the Patents Act expressly provides that the claims must be clear and succinct and must be fairly based upon the matter disclosed in the specification. American Cyanamid Co. v. Berk Pharmaceuticals Ltd. (1973), [1976] R.P.C. 231.

The specification of a patent is also required to end with the claims stating distinctly and in explicit terms the things or combinations that the applicant regards as new and of which he claims exclusive property or privilege. A patent cannot be refused because an inventor has not fully tested and proved it in all its claimed applications. Only if the inventors have claimed more than what they have invented and included substances which are devoid of utility should the claims be open to attack.

In Free World Trust [para. 31], the Court recalled that the Patent Act promotes adherence to the language of the claims in a way that promotes both fairness and predictability. The claim language must be read in an informed and purposive way so as to define the monopoly. Courts should not rely on vague notions such as the “spirit of the invention” to expand the claim language further. As mentioned previously, the claims language will, on a purposive construction, show that some elements of the claimed invention are essential while others are non-essential. The identification of elements as essential or non-essential is made:

(i) on the basis of the common knowledge of the worker skilled in the art to which the patent relates;

(ii) as of the date the patent is published;

(iii) having regard to whether or not it was obvious to the skilled reader at the time the patent was published that a variant of a particular element would not make a difference to the way in which the invention works; or

(iv) according to the intent of the inventor, expressed or inferred from the claims, that a particular element is essential irrespective of its practical effect;

(v) without, however, resort to extrinsic evidence of the inventor’s intention.

(f) There is no infringement if an essential element is different or omitted. There may still be infringement, however, if non-essential elements are substituted or omitted.

The test for determining whether a claimed element is essential is to ask the following two questions set out in Free World Trust:

1) Would it be obvious to a skilled reader that varying a particular element would not affect the way the invention works? modifying or substituting the element changes the way the invention works;

2) Is it the intention of the inventor, considering the express language of the claim, or inferred from it, that the element was intended to be essential? Whirlpool states: “The words chosen by the inventor will be read in the sense the inventor is presumed to have intended, and in a way that is sympathetic to accomplishment of the inventor’s purpose expressed or implicit in the text of the claims.”

In order “to establish that a claim element is non-essential, it must show both

(i) that on a purposive construction of the words of the claim it was clearly not intended to be essential, and

(ii) that at the date of publication of the patent, the skilled addressees would have appreciated that a particular element could be substituted without affecting the working of the invention” Shire Canada Inc v Apotex Inc, 2016 FC 382 at paras 134-143

An invention is an element or a combination of elements that provides a solution to a problem. Where a claim includes solutions to more than one problem it includes more than one invention. If a claim includes solutions to more than one problem, examination should focus on one solution to a problem in performing the purposive construction. The initial choice of solution should be guided by the description, selecting the solution given the greatest emphasis by the inventors. If it becomes necessary to consider a different solution, the analysis should be undertaken anew

2. Description

The Patent Act requires an inventor “to describe correctly and fully what is his invention”, and that “necessarily involves the duty of disclosing the best method of so doing as contemplated by him.” There are consequences for failing to properly disclose an invention, for instance, by claiming more than one has. A disclosure that is not correct and full, or states an unsubstantiated use or operation of the invention, may be found to fail to fulfil 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. Canadian courts have stated in a number of cases the test to be applied in determining whether disclosure is complete.  The applicant must disclose everything that is essential for the invention to function properly.  To be complete, it must meet two conditions:

1. it must describe the invention and define the way it is produced or built (Thorson P. in Minerals Separation North American Corp. v. Noranda Mines Ltd., 1949 CanLII 55 (SCC));
2. The applicant must define the nature of the invention and describe how it is put into operation.

The description must set out clearly the various steps in a process, or the method of constructing, making, compounding or using a machine, manufacture or composition of matter, in such full, clear, concise and exact terms as to enable a POSITA, to make, construct, compound or use it. Subsection 3 requires, in the case of a machine, that the inventor describe their best method of making the machine. The ‘best method’ description is not required for anything else than a machine. In the case of a process, the inventor must explain the necessary sequence, if any, of the various steps, so as to distinguish the invention from other inventions. In the case of a machine, or in any other case in which an invention admits of illustration by means of drawings, the applicant must, as part of the application, furnish drawings of the invention that clearly show all parts of the invention.

According to s.38(1) PA, where a specification refers to a deposit of biological material and the deposit is in accordance with the regulations, the deposit shall be considered part of the specification and, to the extent that subsection 27(3) cannot otherwise reasonably be complied with, the deposit shall be taken into consideration in determining whether the specification complies with that subsection. However, a reference to a deposit of biological material in a specification does not create a presumption that the deposit is required for the purpose of complying with subsection 27(3). On the question of disclosure, it found that the depositing of a sample in a microbial culture available to the public was sufficient, since it will be possible for anyone skilled in the art involved in the invention to reproduce, make or use the invention. Re Application of Abitibi Co. (1982), 62 C.P.R. (2d) 81. The practice of a deposit is simply intended to require the applicant submitting a process involving a micro‑organism unknown and inaccessible to the public as a necessary part of reproducing the invention to deposit a culture of the micro-organism with the authorities.

A failure to meet the first condition would invalidate the application for ambiguity, while a failure to meet the second invalidates it for insufficiency.  The description must be such as to enable a person skilled in the art or the field of the invention to produce it using only the instructions contained in the disclosure (Pigeon J. in Burton Parsons Chemicals Inc. v. Hewlett-Packard (Canada) Ltd., 1974 SCC 2. In the British case Halliburton Energy Services Inc. v. Smith International (North Sea) Ltd., [2006] EWCA Civ 1715, Jacob J. ruled that “Patents are meant to teach people how to do things. If what is “taught” involves just too much [work] to be reasonable allowing for all the circumstances including the nature of the art, then the patent cannot be regarded as an “enabling disclosure.”

Disclosure plays an important role in identifying the steps followed and distinguishing between the discovery of a theoretical principle or of a product occurring in nature and an invention which requires human activity for its development.  This distinction is crucial in the field of patents, since only the latter is an invention within the meaning of the Act, unless the former is associated with a new method of implementation giving a new and unique result. In the Pioneer Hi-Bred Ltd. v. Canada (Commissioner of Patents), 1989 SCC 64 case, only paragraphs 2 and 3 mentioned the part played by the inventor in creating this new variety.  In this regard the specification was limited to describing the basic materials used for cross-breeding, but there was no indication of the genetic engineering involved.  Yet the documentation did demonstrate the existence of various methods of cross-breeding, whether used to improve the yield of a variety or to make it less vulnerable to disease. The cross-breeding was the only really inventive work, according to the Court, since the selective reproduction was consistent with known Darwinian principles. It was apparent that the steps required for selective reproduction presented no problem.  However, an experimenter could only discover the steps involved in crossing through empirical means.  The Court concluded that Hi-Bred had not complied with the disclosure requirement, and was either negligent in failing to describe its procedure correctly or it had indeed made the discovery by chance.

The role of the Commissioner in scrutinising patent applications is extremely important. The grant of a patent monopoly for 20 years from the date filing of the application creates serious anti-competitive effects. Once the subject matter of the patent is fenced in by the claims, others trespass (intentionally or inadvertently) on the forbidden territory at their own risk. The decision of the Commissioner to grant or refuse a patent application is not a matter of discretion. By virtue of subsection 27(1) and section 40, the Commissioner must grant the application if the statutory conditions are met, and must not grant the application if the statutory conditions are not met. Once the patentability criteria are met, there is no discretion on the part of the Commissioner to deny a patent on a particular subject matter of invention.

1. National Application

Figure 1: CIPO, IP Roadmap 

Filing a Patent Application at the Canadian Intellectual Property Office (CIPO)

To receive an official filing date in Canada, an applicant must comply with the requirements of s.27 PA, as further specified in the Patent Rules.

Submitting an application fee is not a requirement to secure a filing date for your patent application.  If the application fee is not submitted when the patent application is filed, the Commissioner will send the applicant a notice requiring the submission of the application fee and the late fee within three months of the date of the notice. If the application fee and late fee are not submitted within the three months after the date of the notice, the application will be deemed withdrawn.

Once CIPO accepts the application for filing, the application is assigned a number and filing date (s.28 PA). From that moment on until the Commissioner reaches a decision, the application will be pending. A complete patent application includes the information required to obtain a filing date as well as the following:

• Formal petition for grant of a patent
• Abstract of the invention
• Claim or claims to the invention
• Any drawings mentioned in the description
• A biological sequence listing, if applicable, in electronic format
• Appointment of a patent agent, when required
• The application fee
• A signed small entity declaration, if applicable
• A statement of entitlement
• Names and addresses of the inventors

Claiming Priority

Normally an application is entitled to priority as of the date of its filing. In the case of convention applications, however, the applicant requests the recognition of an earlier priority date. This procedure exists in the case of an application for a patent for an invention filed in Canada by any person entitled to protection under the terms of any treaty or convention relating to patents to which Canada is a party, who has, or whose agent or legal representative has, previously regularly filed an application for patent for the same invention in any other country which by treaty, convention or law affords similar privilege to citizens of Canada. Such an application has the same force and effect as it would have if filed in Canada on the date on which the application for patent for the same invention was first filed in such other country, provided the application in Canada is filed within 12 months from the earliest date on which any such application was filed in such other country.

Section 10(2) PA states that the application remains confidential for a period of eighteen months from filing, after which it is open to public inspection. If the applicant so wishes, they may request to have their application open to public inspection earlier. The confidentiality period begins on the filing date of the application or, where a request for priority has been made in respect of the application, it begins on the earliest filing date of any previously regularly filed application on which the request is based.

Requesting examination

The application will not automatically be examined. Pursuant to s.35(1) PA, the applicant must formally request examination and pay the examination fee. This request must be made within four years of the Canadian filing date.  If a request for examination is not received within the prescribed time limit a late fee will also need to be paid.  A Commissioner’s Notice will be sent to the applicant shortly after the due date.  The notice will require the applicant to make the request, pay the request for examination fee and the late fee before the end of two months after the date of the notice. If the request is not made, the request for examination fee and the late fee are not paid within the late fee period, the application will be deemed abandoned.

There are several reasons why an applicant might file an application and not automatically request examination. One reason may be that the applicant needs time to assess the feasibility or marketability of their invention. If so, filing provides some protection for the invention, possibly making competitors less likely to infringe on it (that is, make, use or sell it) for fear of having to pay retroactive compensation should the patent eventually be granted. However, if the applicant fails to request examination within the four-year period and the reinstatement period has passed, anyone will be able to freely make, use or sell the products or processes described in the application. Once the request is made, the examination process may take more than two years.

In the circumstances mentioned in s.84(1) of the Patent Rules, applicants may request an advanced examination of a patent application that is open to public inspection. An extra fee will apply.  The Patent Rules provide that a request for advanced examination of the application is admissible in cases where failure to do so is likely to prejudice the applicant’s rights (primarily in the context of fierce competition) or if the application relates to technology the commercialization of which would help to resolve or mitigate environmental impacts or to conserve the natural environment or natural resources.

Filing prior art and protests

After the patent application is made available to the public, i.e. 18 months after the date of filing, any person may file with the Commissioner prior art, consisting of patents, applications for patents open to public inspection and printed publications, that the person believes has a bearing on the patentability of any claim in an application for a patent (s.34.1 PA). A person who files prior art with the Commissioner must explain the relevance of such prior art. In addition, s.35 PA provides that anyone may request the examination of a patent application by CIPO examiners. Such requests are made available to the public.

(Re)Consideration by the examiner

It is not uncommon for the patent examiner to object to a claim, either because there exists relevant prior art relating to one or more claims in the application, or because some claims are deemed to be obvious to a POSITA. The examiner’s report, called a “Patent Office action,” may object to the application as a whole or only to some claims, or it may ask for other changes in the application. The applicant may respond to the objections, following which the examiner will prepare a second office action, known as a “notice of allowance” informing the applicant that the application is allowable or it may be a request for further amendments. If further amendments are necessary, the request for amendments may be in the form of a written office action or the examiner may contact the applicant or their patent agent to discuss the amendments required. This exchange may be repeated until the examiner allows the application or states that the action is final.

Grant or Rejection of the Patent

At the end of the examination process, the patent will be granted if the examiner approves the application and if the fees are paid. To maintain the patent rights in effect, annual fees must be paid on or before the prescribed dates.

It the examiner makes a final objection to the application, the applicant has the right to appeal to the Commissioner of Patents, requesting that the Commissioner review the examiner’s objection. The review is conducted by the Patent Appeal Board. If the Commissioner objects to your appeal and refuses to grant a patent, the case is subject to judicial review by the Federal Court of Canada.

Once granted, the patentee must pay the prescribed fees on or before the prescribed dates to maintain the rights accorded by a patent issued under this Act in effect. Failure to pay the fees will result in the abandonment of protection.

2. International PCT Application

For any inventor who wishes to obtain patent protection in more than one country, the most efficient way is to apply through the mechanism put in place by the Patent Cooperation Treaty.

Figure 2: WIPO, PCT application roadmap

This workings of the PCT are best explained by the WIPO itself:

Once a patent application has gone successfully through the entire examination process and the Commissioner of Patents has issued the patent, the protection it offers is very broad. Like for copyright, the law grants the patentee a bundle of exclusive rights on their invention. The following section describes the scope of patent protection in the context of infringement proceedings, as well as the exceptions on these rights.

1. Infringement

Pursuant to s.42 PA, every patent granted under the Act confers on the patentee the exclusive right, privilege and liberty of making, constructing and using the invention and selling it to others to be used. The duration of the patent is twenty years from the filing date. The presumption of validity of a patent is established by subsection 43(2) PA. The scope of patent protection is therefore very broad and anyone outside the patentee or their legal representatives who makes, constructs, uses or even sells the invention without prior permission is liable for patent infringement.

To establish infringement, the patentee must prove, on a balance of probabilities, the following elements:

1. The carrying out of a prohibited act;
2. The prohibited act must have been done after the publication of the patent application, or the issuance of the patent where no early publication occurs;
3. The prohibited act must have been done in the country where the patent has been granted;
4. The prohibited act must be in relation to a product or process falling within the scope of a claim of the patent.

Of the four elements listed above, two can be easily ascertained, e.g. whether the prohibited act took place after the publication of the patent application and in a country where patent protection was granted. Since the four elements are cumulative, these elements should be established first before going further with the analysis. Of course, this would include checking whether the patent protection is still in force, e.g. whether the patent application was filed less than twenty years prior to the alleged acts of infringement and if so, whether the patentee has paid the prescribed annual fees to maintain protection.  The two other elements of a patent infringement claim, regarding the nature of the act and the scope of the claims, are less straightforward and will likely lead to interpretation issues. First, the plaintiff must establish that the defendant’s actions with respect to the product or process actually qualify as making, constructing, using or selling the invention without the patentee’s consent. Second, the allegedly infringing product or process must be covered by the claims of the patent.

a. Did the Defendant Carry Out a Prohibit Act?

Infringement is generally a question of fact. Answering the question whether a defendant to a patent infringement action has made, constructed, or sold a product is usually not very problematic, compared to establishing whether a defendant has made use of the invention in violation of the patentee’s exclusive rights. Recognising the difficulty of proving the use of a patented process, the law gives the patentee a helping hand: section 55.1 PA provides that ‘in an action for infringement of a patent granted for a process for obtaining a new product, any product that is the same as the new product shall, in the absence of proof to the contrary, be considered to have been produced by the patented process’. The Saccharin doctrine [which gets its name from Saccharin Corporation, Ld. v. Anglo-Continental Chemical Works, Ld. (1900), 17 R.P.C. 307] states that a process patent can be infringed by the importation, and use and sale in Canada, of a product manufactured abroad by another person using the patented process. By the sale of saccharin, in the course of the production of which the patented process is used, the Patentee is deprived of some part of the whole profit and advantage of the invention, and the importer is indirectly making use of the invention.

“‘Use” applies both to patented products and processes, and also to their output” [Vaver, Intellectual Property Law: Copyright, Patents, Trade-marks, 2011, p. 377]. The guiding principle when investigating whether a use was made of a patented invention is whether the defendant’s activity deprived the patentee in whole or in part, directly or indirectly, of the full enjoyment of the monopoly conferred by law. In practice, patentees will miss out on the fruits of their invention and the full enjoyment of their monopoly when another person, without consent, uses the invention to further a business interest.  The fact that a defendant benefits from the unauthorised use of a patented invention for its own commercial interests may be an indication that an infringing use has taken place.

The landmark case on the interpretation of the concept of ‘use’ in s.42 of the Patent Act is Monsanto Canada Inc. v. Schmeiser [2004 SCC 34] in which the Supreme Court was asked to give meaning to the word ‘use’ in relation to a patent on a genetically modified canola seed. Did Mr. Schmeiser ‘use’ Monsanto’s patented invention contrary to s.42 PA, when he harvested canola plants from his fields without having first purchased the patented seeds from the Company? To find for infringement in this case, a legal connection had to be established between the patented seed and the harvested plant. The majority of the Court recalled that ‘a defendant infringes a patent when the defendant manufactures, seeks to use, or uses a patented part that is contained within something that is not patented, provided the patented part is significant or important. In the case at bar, the patented genes and cells are not merely a “part” of the plant; rather, the patented genes are present throughout the genetically modified plant and the patented cells compose its entire physical structure’. Referring to old English cases, the Court pointed out that ‘Exploitation of the stand-by utility of an invention uses it to advantage’.

And, while the intention of the defendant is generally irrelevant to a finding of infringement, intention becomes relevant where a defendant possesses an invention without use, with a view to exploiting the ‘stand-by’ utility of the invention. Admittedly the onus of proving infringement would become impractical and unduly burdensome in cases of possession, if the patent holder was required to demonstrate the defendant’s intention to infringe. As the Court explains, if the patent holder is able to establish that the defendant possessed the patented invention, it is up to the defendant to show the absence of the “additional ingredient”. In other words, a defendant in possession of a patented invention in commercial circumstances may rebut the presumption of use by bringing credible evidence that the invention was neither used, nor intended to be used, even by exploiting its stand-by utility. The defendant’s benefit or profit from the activity may be relevant at the stage of remedy, but not in determining infringement. Applying the law to the facts of the case, the majority of the Court concluded that:

“[72] Monsanto’s patent gives it a monopoly over the patented gene and cell.  The patent’s object is production of a plant which is resistant to Roundup herbicide. Monsanto’s monopoly enabled it to charge a licensing fee of $15 per acre to farmers wishing to grow canola plants with the patented genes and cells.  The appellants cultivated 1030 acres of plants with these patented properties without paying Monsanto for the right to do so.  By cultivating a plant containing the patented gene and composed of the patented cells without licence, the appellants thus deprived Monsanto of the full enjoyment of its monopoly.”

The next question arising in this case was whether, by cultivating plants containing the cell and gene, Mr. Schmeiser used the patented components of those plants. Citing Vaver, the Court ruled in the affirmative saying that the patentee would otherwise be deprived of the full enjoyment of the monopoly granted by the patent.

b. Did the Prohibited Act Fall within the Scope of the Claims?

Where a defendant is found to have made, constructed, used or sold a product, the following question to be asked is whether that product falls within the scope of the patent claims. If the defendant’s product is not covered by the claims, then there can be no case of infringement. To answer this question a court will need to interpret the patent claims. This is a question of law. As mentioned previously, patent claims must receive a purposive construction. Such a method of interpretation essentially mandates the consideration of the claims using the modern principles of legal interpretation, which are often grouped under the headings of the literal, contextual and purposive methods.  When interpreting patent claims, courts must be wary of the patent bargain: the interpretation should be fair to both patentee and public.

The question of infringement is determined by a review of the defendants’ product in the light of the patent in issue and not by a comparison with the plaintiffs’ own commercial product. Although infringement can be found based on the text of the plaintiffs’ patent, even if textual infringement is not present, the trier of fact must move on to determine whether the pith and substance of the plaintiffs’ patent has been infringed. Infringement exists where there is an act which interferes with the full enjoyment of the monopoly granted to the patentee. Keeping with the teachings in Free World Trust, patent claims must be interpreted in a manner that gives its just meaning to the patent monopoly, looking at the essential and non-essential elements of the claims. Four rules of patent interpretation influence the purposive construction of the claims: 1) reliance on the disclosure and drawings; 2) reliance on extrinsic evidence; 3) the claims differentiation principle; and 4) the principle that the claims are not limited by the disclosed embodiments. In Bauer Hockey Ltd. v. Sport Maska Inc. (CCM Hockey) [2020 FC 624], Grammond J. draws a useful summary of the rules of interpretation in the context of patent claim construction.

Reliance on the Disclosure and Drawings

In Bauer Hockey Ltd. v. Sport Maska Inc. (CCM Hockey), the plaintiff argued that when interpreting a claim, one should not have recourse to the disclosure and drawings if the language of the claim is clear. Relying on the modern method of interpretation, Grammond J. reminded that ‘the method aims at helping the interpreter find clues about the meaning of a legal writing. There is no hierarchy of these clues, nor any predetermined order in which they are considered. In particular, the modern method rejects what is known as the plain meaning rule, or the idea that if one category of clues – the text – provides a clear answer, the other categories of clues are to be disregarded.’ In other words, the patent claims must be interpreted in the context of the specification as a whole, including the Disclosure and Drawings. The whole of the specification may provide useful information to understand the meaning of a word or term used in a claim. However, parts of the specification may not be borrowed from to enlarge or contract the scope of the claim as written, as this would affect the patent bargain and reduce legal certainty.

Reliance on Extrinsic Evidence

With respect to the use of extrinsic evidence in the interpretation process, Grammond J. recalls the general rule according to which a legal writing must ‘be interpreted according to information unavailable to its addressees. For that reason, exclusionary rules restrict the scope of the evidence that may be used to assist interpretation’. Extrinsic evidence is in principle inadmissible if it was unavailable to the other party. Patents are public documents. Their meaning should not depend on information that is not accessible to the public. This explains at least in part the general prohibition on the use of extrinsic evidence to construe patent claims. Prohibited extrinsic evidence may include other patents, patent applications and the testimony of the inventor. By contrast, s.53.1 PA states that communications between the patentee and the Patent Office – otherwise known as the patent prosecution history – may be admitted into evidence to rebut any representation made by the patentee in the action or proceeding as to the construction of a claim in the patent. The Federal Court has since recognised that the purposive construction requires consideration of not only the claims and the disclosure, but also “the substance behind intentional amendments to the claims issued in Canadian patents”. Section 53.1 provides a limited exception to admit as evidence parts of communications between the patentee and the Patent Office during the prosecution of the patent, but only to rebut a representation by the patentee in an action (Canmar Foods Ltd v TA Foods Ltd, 2019 FC 1233 at paragraph 71).

Claims Differentiation Principle

The claims differentiation principle presumes that patent claims are drafted so as not to be redundant. Thus, different claims have different scopes. Independent claims are understood to include more than dependent claims; a limitation in the dependent claim should not be read into the independent claim. In the eyes of Grammond J., this principle is simply an application of the contextual method of interpretation: when looking at context, one should assume that each component of a legal document plays a specific role and that none is redundant. In Bauer Hockey Ltd. v. Sport Maska Inc. (CCM Hockey), Grammond J. further explains that

[68] Sections 60–63 of the Patent Rules allow applicants to describe inventions by way of multiple claims. A claim is “dependent” if it includes by reference all the features, or “limitations,” of another claim, as well as additional features. The principle of claims differentiation simply means that the additional feature that distinguishes a dependent claim should not be implied in the independent claim, as that would render the former redundant.

The presumption against redundancy is rebuttable, however, if there is evidence pointing to the contrary.

Claims Not Limited to Preferred Embodiments and Essential Elements

Pursuant to s.27(3)(c) PA and section 56(1)(f) of the Patent Rules, the inventor must describe “at least one mode for carrying out the invention.” This is known as the “preferred embodiment” or the “best mode”. It is a settled principle in the case law, however, that “the description of the preferred embodiments is not meant to include all the possible embodiments of the invention claimed”. Some elements of the claims will be considered essential and some will not. When the inventor describes the preferred embodiment or illustrates the invention in a drawing, one should not presume that everything described or shown is essential. There may be other ways of practicing the invention, but this does not mean that the scope of the claims should be widened after the fact.

c. Defence to an Infringement Claim

The most common defence to a patent infringement claim is to invoke the patent’s invalidity. This is expressly allowed under s.59 PA which states that “[t]he defendant, in any action for infringement of a patent may plead as matter of defence any fact or default which by this Act or by law renders the patent void, and the court shall take cognisance of that pleading and of the relevant facts and decide accordingly.”

The validity of a patent can be attacked on one or more of the following grounds:

1. The patented invention is not a patentable subject-matter, contrary to s. 2 PA;
2. The patented invention was not new, non-obvious and/or useful at the time of filing the application contrary to ss. 2, 28.2, & 28.3 PA;
3. The disclosure is insufficient, contrary to s. 27(3)(a) PA;
4. There is a lack of enablement, contrary to s. 27(3)(c) PA;
5. Double patenting [see Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research, 2020 FCA 30]

Note that these grounds for attack are not exhaustive. A defendant may bring in defence any fact or default which by the Patent Act or by law renders the patent void. Section 60(1) PA allows any interested person to ask the Federal Court to declare a patent or any claim in a patent invalid or void. This is known as an impeachment action. In reverse, s.60(2) allows any person who has ‘reasonable cause to believe that any process used or proposed to be used or any article made, used or sold or proposed to be made, used or sold by him might be alleged by any patentee to constitute an infringement of an exclusive property or privilege granted thereby, he may bring an action in the Federal Court against the patentee for a declaration that the process or article does not or would not constitute an infringement of the exclusive property or privilege’. Through such a declaration of non-infringement, a third party can safeguard their interests and hope to stay clear of further infringement procedures in the future.

2. Exceptions

Like any other property right, patent rights are not absolute. Nevertheless, the Patent Act contains only a limited number of exceptions to the exclusive rights. This stands in sharp contrast with the copyright regime, which recognises numerous exceptions judged to be in the public interest. Patent law’s divergent approach to exceptions can likely be explained by the patent regime’s utilitarian goal of ensuring the patent owner’s full enjoyment of the monopoly conferred by law, in exchange for disclosure of the invention. The fact that patent law is an industrial property right that affords protection for a relatively short period of time against acts of a commercial nature done with respect to the invention gives further justification to the limited need for exceptions. Acts that are of a private nature or that do not affect the commercial exploitation of the invention would normally not fall under the scope of the owner’s exclusive right. This is the case of the ‘regulatory review exception’ and the ‘experimentation exception. On the other hand, the patent regime must also be fair towards third parties who had, in good faith, started using or producing the patented invention before the claim date. The ‘prior use’ exception covers this set of circumstances.

a. Regulatory Review Exception

This provision of the Patent Act is invoked primarily in relation to patents on pharmaceutical products. A pharmaceutical manufacturer who intends to sell a generic version of a patented medication is pursuant to s.55.2 PA not amenable to being sued for patent infringement solely for having made or tested an allegedly infringing product for the purpose of applying for a Notice of Compliance (see section G. below) before the expiration of the patent. Strict conditions for the exercise of this exemption are set by regulation. Section 55.2(6) affirms that ‘for greater certainty, subsection (1) does not affect any exception to the exclusive property or privilege granted by a patent that exists at law in respect of acts done privately and on a non-commercial scale or for a non-commercial purpose’.

Although the Patent Act recognised the ‘regulatory review exception’, the Regulations do create a statutory cause of action – namely, an action pursuant to section 6(1) of the Regulations – that may be brought by first persons and patent holders while a drug is awaiting regulatory approval from Health Canada. Absent an actionable act of infringement, a patentee would have no means under the Patent Act to pre-emptively sue or seek an injunction to prevent a generic from coming to market with an infringing product, unless it can plead facts showing that the generic is using the invention for purposes other than seeking regulatory approval or unless it can meet the very stringent test for bringing a quia timet action.

In Eli Lilly Canada Inc. v. Apotex Inc., [2020 FC 814], Apotex could successfully establish that the material it had produced was only used for regulatory testing, that it was not converted into finished dose, that the material was not tableted, that it was not sold in the Canadian market, that it was not formulated nor sold for export.

b. Experimentation Exception

An experimentation use exception is commonly found in foreign patent legislation even if it is rarely invoked. The Canadian Patent Act contained an ambiguous provision which could be interpreted in this sense, until it was amended in 2018 to clarify that an act done for the purpose of experimentation relating to the subject matter of a patent does not constitute an infringement. The Governor in Council may make regulations respecting the factors to be considered by the court in determining whether an act is, or is not, committed for the purpose of experimentation. So far, no regulation has been adopted, but no legal dispute involving facts that could fall within the ambit of this provision has arisen either. Other jurisdictions with a similar provision tend to interpret this provision narrowly and demand that the experimentation be limited to the sole study of the patented product or process and must not be used as a means to develop other commercial products.

c. Prior Use Exception

The rights of prior users have long been recognised in the Patent Act, but this conditions for exercise were seriously revisited in the 2018 round of legislative amendments. The recognition of a third party’s prior use is an exceptional event in the patent scheme that has the potential to affect the patent owner’s full enjoyment of the monopoly granted by the law. For this reason, it is subject to very strict conditions of exercise, set out in subss. 56(2) to (11) PA. In essence, the third party’s scope of action with respect to the subject matter is limited in terms of use and further transfers. To protect patent owners from falling victim to unscrupulous former employees or competitors, the Act now expressly excludes the application of this provision ‘if the person referred to in that subsection or that paragraph was able, as the case may be, to commit the act or make the preparations to commit the act only because they obtained knowledge of the subject-matter defined by the claim, directly or indirectly, from the applicant of the application on the basis of which the patent was granted and they knew that the applicant was the source of the knowledge.’

The Canadian pharmaceutical market is home to two opposite forces: manufacturers of innovative pharmaceutical products (“innovators”) and manufacturers  of generic products (“generics”). Innovators invest enormous amounts of money, time and expertise in the research and development of new pharmaceuticals for human and animal consumption. They rely heavily on patent protection for the new drugs they develop, in order to recoup their investments and generate profits. By contrast, the main business of generics is to develop alternative versions of the innovators’ drugs, that they sell at lower prices. Generics can afford to sell their products at lower prices, because they are able to create alternative drugs without engaging in the same levels of expenditures in research and development as the innovators.

The rights of innovators are governed in Canada by three sets of regulations: the Patent Act, the Patented Medicines (Notice of Compliance) Regulations, and data exclusivity in the Food and Drug Regulations. The regulatory regime is devised to enure the safety and efficacy of that medicine but also to preserve the economic interests of the manufacturer. To sell a drug in Canada, a manufacturer must be issued a Notice of Compliance (“NOC”) from the Minister of Health under the Food and Drug Regulations. An NOC issued by the Minister of Health in respect of a drug gives the manufacturer authorization to market that drug in Canada. In order to obtain an NOC, an innovator must submit a New Drug Submission (“NDS”) which confirms the drug is both safe and effective. A generic can submit an Abbreviated New Drug Submission (“ANDS”) with a reference to another drug which has received an NOC. The option to submit an ANDS eliminates the need for generics to conduct extensive research and development to bring their products to market.

The PMNOC regime initially came into force on March 12, 1993, under subsection 55.2(4) of the Patent Act. It created a Patent Register with Health Canada on which innovators can list patents that are relevant to their drug submissions for regulatory approval. The goal of the PMNOC Regulations was to prohibit generics from marketing their drugs until the expiry of the associated patents, but not a moment later. Generics can accept that they will not get regulatory approval until expiration of the listed patents. However if a generic would like approval for a generic version of a drug prior to the expiry of the patents associated with it, the generic must send a Notice of Allegation (“NOA”) to the innovator claiming that its product does not infringe the innovator’s patents or, alternatively, that the innovator’s patents are invalid, along with the legal and factual basis for the allegation.

The PMNOC Regulations were amended in 2017. Part of the amendments were brought to take account of the creation of the Certificate of Supplementary Protection (CSP). Canada implemented a sui generis regime of additional “patent-like” protection for pharmaceuticals described in Comprehensive Economic and Trade Agreement between the European Union and Canada, Article 20.27, known as a Certificate of Supplementary Protection (‘CSP’), in new sections 104-134 to the Patent Act. According to the Amended Regulations, the innovator has forty-five days after the receipt of the NOA to initiate an action in the Federal Court asking for a declaration that the making, constructing, using or selling of a drug in accordance with the NOA would infringe any patent or certificate of supplementary protection that is the subject of the allegation set out in the notice. The generic may bring a counterclaim for a declaration of patent or certificate of supplementary protection invalidity. The Minister of Health shall not issue an NOC to the generic for twenty-four months or the resolution of the court action, whichever arrives first. The Federal Court’s decision on whether the allegations in the NOA are founded is determinative of validity and infringement. If the innovator succeeds, the Federal Court will declare that the actions proposed by the generic in the NOA would result in infringement of the innovator’s patent and the Minister will be prohibited from issuing an NOC to the generic during the life of the patent(s) or CSPs at issue. If the generic succeeds, the Federal Court will declare that the innovator’s patent(s) or CSP are invalid and the Minister will issue an NOC to the generic.

In ViiV Healthcare ULC v. Canada (Health), 2020 FC 756 (Justice Fuhrer), the Court was asked to consider whether the Minister’s refusal to issue a CSP for JULUCA was reasonable? This involves the more granular question: was Minister’s interpretation of Patent Act s 106(1)(c) and Certificate of Supplementary Protection Regulation (CSPR) s.3(2)(a), namely that an eligible patent must claim all the medicinal ingredients in a combination drug to support the issuance of a CSP, consistent with the text, context and purpose of these provisions? The reasons deal only with the appropriate standard of review and whether the Minister reasonably interpreted Patent Act s 106(1)(c) and CSPR s 3(2)(a) in a manner consistent with CETA, as required by CIA s 3, by relying only on the CSPR Regulatory Impact Assessment Statement (“RIAS”) and associated Guidance Document. Fuhrer J. granted the judicial review application ruling that the Minister unreasonably considered ViiV’s submissions based on CETA Article 20.27 regarding the proper interpretation of Patent Act s 106(1)(c) and CSPR s 3(2)(a), by failing to consider CETA itself in addition to the CSPR RIAS and Guidance Document. This matter was remitted to the Minister for redetermination.

Data exclusivity protects innovator data from being used by generic competitors for a set period of time. The data protection regulations are promulgated under the Food and Drugs Act to implement Canada’s treaty obligations to protect data associated with the approval of certain pharmaceutical products, so as to encourage the development of new drugs. For the first six years after an innovative drug receives regulatory approval, a generic manufacturer may not submit an NDS or an ANDS on the basis of a direct or indirect comparison between a new drug and an innovative drug. For the first eight years after regulatory approval, the Minister of Health cannot grant market authorization to a product that would directly or indirectly rely on clinical trials funded by the company that obtained the regulatory approval. The eight years can be extended by six months for innovative products that have been the subject of clinical trials in pediatric populations.