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From antibodies to X-rays: an overview of patent eligibility in Canada




The trend for deciding patentability based on subject-matter eligibility is growing. David Schwartz and Sanro Zlobec of Smart & Biggar look at the situation in Canada, where the relevant jurisprudence remains scant

The Canadian Patent Act is a blank canvas with respect to subject-matter eligibility. The term "invention" is defined as "any new and useful art, process, machine, manufacture or composition of matter" or improvement therein. The sole positive exclusion from patentability is the prohibition on patenting "any mere scientific principle or abstract theorem". TRIPs (Agreement on Trade-Related Aspects of Intellectual Property Rights) and NAFTA (North American Free Trade Agreement) each provide that contracting states may exclude from patentability inventions "the exploitation of which would be contrary to ordre public". However, Canada did not enact such a provision when implementing these trade agreements. Indeed, in 1993, Parliament repealed the prohibition against patenting an invention that has "an illicit object in view". Therefore, the scope of subject-matter eligibility in Canada is shaped almost exclusively by the decisions of our courts and policies of the Canadian Intellectual Property Office (CIPO).

Life sciences

Products of nature

Canada has no counterpart to the US Supreme Court Myriad decision. CIPO has historically granted patents for nucleic acids isolated from their natural environment. The courts have considered resolution of enantiomers of a known compound to be sufficient basis for conferring novelty (see for example AstraZeneca Canada v Apotex, 2015 FCA 158) and perhaps an analogy can be drawn to the isolation of biomolecules from their native milieu.

The greatest difficulties in patenting biomolecules per se lie with antibodies. But this is an issue of sufficiency of disclosure rather than subject-matter eligibility. Until recently, CIPO objected to claims to monoclonal antibodies in the absence of working examples. The current debate relates to humanised antibodies, CIPO at present requiring disclosure of the sequences of the hypervariable regions of the antibody to be humanised (Commissioner's Decision 1296).

Methods of medical treatment

Methods of medical treatment have been found unpatentable as being "essentially non-economic and unrelated to trade, industry or commerce" but instead related "to the area of professional skills" (Tennessee Eastman v Canada (Commissioner of Patents), [1974] S.C.R. 111; Shell Oil v Commissioner of Patents [1982] 2 S.C.R. 536). But a claim to a compound for use in therapy has been found patentable as a "commercial offering" (Apotex v Wellcome Foundation, 2002 SCC 77) and claims of the Swiss, German, and EPC 2000 type can be obtained. Recent litigation has focused on dosage regimens, which may be patentable if a claim does not require "professional decision making" (AbbVie Biotechnology v The Attorney General of Canada, 2014 FC 1251).

Diagnostic methods

The Canadian courts have not considered the patentability of diagnostic methods, so there is no counterpart to the United States Supreme Court Mayo decision. Absent a therapeutic benefit, CIPO has not invoked the so-called "professional skills" objection that apparently grounds the method of treatment prohibition. However, on June 29 2015, CIPO issued Patent Notice PN 2015-02 Examination Practice Respecting Medical Diagnostic Methods. An invention solving a "data acquisition problem" (such as a new technical method of quantitating a marker) likely will be found patentable, whereas an invention that is characterised as solving only a "data analysis problem" (such as associating a marker with a disease condition) may be found unpatentable. It appears likely that CIPO will assert that a method is non-statutory if it concludes that the only new element of a claim is the identification of a correlation between a known marker and a disease condition.

Life forms

A division is drawn between patentable "lower life forms" such as microorganisms (Re Application of Abitibi Co. (1982) 62 CPR (2d) 81), and "higher life forms", namely animals and plants (and their parts). The Supreme Court of Canada found the "Harvard Mouse" ineligible for patent protection as not being a "composition of matter" or "manufacture" and extended its reasoning to plants in arguably obiter remarks (Harvard College v Canada (Commissioner of Patents), 2002 SCC 76). However, claims directed to uses of animals have been permitted and, indeed, the Harvard College patent issued with claims directed to use of a transgenic non-human mammal to assay for carcinogens.

There is no on-point Supreme Court authority concluding that plants are unpatentable, although what was then the Federal Court of Canada (Appeal Division) reached this conclusion at least with respect to plants produced by cross-breeding methods (Pioneer Hi-bred v Canada (Commissioner of Patents), [1987] 3 FC 8). On appeal, the Supreme Court found Pioneer's plants to be unpatentable on the basis of insufficiency of disclosure and did not address the question of subject-matter eligibility: [1989] 1 S.C.R. 1623. The issue of whether a breeding method is patentable was not squarely addressed, as the claims at issue related to plants per se, not methods of producing them.

Some relief is found in the decision of the Supreme Court of Canada in Monsanto Canada v Schmeiser 2004 SCC 34. The Court confirmed that a plant cell is eligible for patent protection, and found that a claim to a plant cell was infringed by the growing of plants from seed. At present, CIPO grants claims to both plant and animal cells and to uses of novel plants and animals.

High tech

Computer-related inventions and Amazon

There is typically little debate in Canada about the patent eligibility of inventions that improve the performance of an actual computer, such as a new piece of equipment or a new memory storage process. These inventions, which are necessarily implemented by a computer because they pertain to the operation of the computer itself, have always been considered statutory subject matter in Canada. Where there has been some controversy in recent years, however, is in the area of inventions that can be described, in essence, as a flowchart executed by a computer system, thereby defining a new functionality or behaviour of the computer.

The closest that Canadian courts have come to addressing this issue is the 2011 Federal Court of Appeal decision in The Commissioner of Patents v Amazon.com Inc. 2011 FCA 328 and the CIPO guidance memoranda that followed. In Canada, the demarcation between patentable and non-patentable subject matter in the computer-related arts has not been drawn often, and thus the Amazon decision was received with great interest. The invention in Amazon was the famous one-click ordering system, which allows customers shopping online to make purchases with a single click, circumventing the process of entering address and billing information in the traditional shopping cart model of online shopping. While the appellant ultimately prevailed and obtained a patent, the Court's judgment revealed that support for computer-implemented inventions, while strong, had its limits.

Following Amazon, CIPO released guidance that sets out its interpretation of Amazon and outlines the approach to be taken by examiners in the examination of applications in the computer-related arts. CIPO's view is that the claims are presumed to solve a "problem", and an inquiry is needed into whether the computer is "essential" to solving that problem. The identification of this problem becomes the focal point of the patentable subject matter inquiry, because if the computer is deemed to be essential to solving the problem, the claim will generally be found patent eligible.

Depending on the type of problem that is identified, CIPO may consider the computer to be more or less likely to be an essential component of the corresponding solution. In this regard, when the use of a computer solves a so-called computer problem (relating to actual operation of the computer and dealing with aspects such as controlling a chip, or firmware, for example), the computer is more likely to be found as essential to the solution. On the other hand, when the use of a computer solves a problem that is not a computer problem (a finding that may be triggered by a lack of technical detail or focus on calculations according to a specific equation that could, in theory, be performed with pen and paper), then the computer is less likely to be considered essential, and consequently the subject matter is less likely to be found patent eligible.

Given that the "problem" inquiry usually arises for the first time during prosecution, applicants have had to apply some creativity to cast the problem in such a way as to make it apparent that the solution requires a computer. In this regard, claim language may sometimes be aligned with that of claims in respect of which certain decisions of the Commissioner of Patents have confirmed the computer to be essential. This includes, for example, language such as "monitoring of operating characteristics" found in Commissioner's Decision 1366.

Business methods

It should be mentioned that the Amazon court confirmed that there is no exclusion for business methods patents in Canada, and further directed CIPO to be "open to the possibility that a novel business method may be an essential element of a valid patent claim". On the other hand, the mere existence of a practical embodiment or application will not, in itself, allow an invention to cross over into patent-eligible territory. Thus, in practice, it has been difficult for applicants to succeed during prosecution when they cannot frame the problem solved by a business method as one whose solution necessitates a computer or other similarly tangible element.

Electromagnetic radiation and transitory signals

The Canadian courts have not addressed the patentability of transitory electromagnetic signals or the like. Contrast this to the situation in the US, where transitory forms of signal transmission have been found unpatentable (In Re Nuijten 500 F. 3d 1346). CIPO has nevertheless concluded that "forms of energy, such as electromagnetic and acoustic signals, regions of the electromagnetic spectrum, electric currents, and explosions are considered not to be manufactured from or composed of matter in the sense intended by the Patent Act" (Manual of Patent Office Practice, section 12.05.04).

The future

The extent to which the problem/solution approach adopted by CIPO is valid under Canadian patent law has not yet been tested before the courts. Many in fact question the manner in which the problem and solution are identified, as it seems to sidestep notions such as the actual claim language and the inventor's intent, both of which stem from jurisprudence and have for years been part of the inquiry into claim construction in Canada. Therefore, whether the courts would apply the same approach as CIPO remains an open question, especially considering that Amazon states that, when assessing compliance with subject matter eligibility, "[t]he focus should remain on the principles to be derived from the jurisprudence".

Also, in the case of an issued patent, which carries with it a presumption of validity, it is unknown to what extent an invalidity defence could be successfully built around having identified, unilaterally and post facto, a problem whose solution does not seem to require a computer.

In light of the significance of some of these unanswered questions, it is expected that the issue of patent eligibility of computer-implemented inventions will resurface in the courts. When this occurs, it is hoped that the ensuing judicial wisdom will ensure that the patent rights available for computer-related inventions in Canada are as strong as their economic impact. Until then, applicants and patentees operating in this technology space may want to continue building their case for essentiality of a computer around the problem/solution paradigm with the help of their Canadian representatives.

Outlook

With the paucity of jurisprudence, subject-matter eligibility in Canada remains in its infancy. However, the trend seen in Canada and elsewhere to hinge patentability on broad questions of subject-matter eligibility rather than novelty, obviousness, and sufficiency of disclosure, suggests that this is an area where further scrutiny by the courts is needed.

 

David Schwartz

David Schwartz is a partner in Smart & Biggar's Ottawa office, and is the current president of the Intellectual Property Institute of Canada (IPIC). Since 1994, David has practised exclusively in the IP field with a focus on patent law, particularly in biotechnology, pharmaceuticals and chemistry. He has acted on behalf of a comprehensive range of clients, including start-ups, early-stage ventures, universities, government organisations and multinational corporations. His client activities involve diverse areas such as plant biotechnology, stem cells, organic chemistry, materials science, diagnostics, pharmaceuticals, immunology, vaccines, water filtration, nutriceuticals, expression systems and assays.

In his patent prosecution practice, David frequently advises clients on regulatory matters relating to the Patented Medicines (Notice of Compliance) Regulations and listing patents with Health Canada, data protection under the Food and Drug Regulations, and matters concerning the Patented Medicine Prices Review Board. He also has expertise in managing global IP portfolios and in performing freedom-to-operate and infringement analysis and IP due diligence. He has handled first-to-invent conflicts under the pre-1989 Patent Act and appears regularly in oral proceedings before the Patent Appeal Board. David has also testified before the House of Commons Standing Committee on Industry, Science and Technology with respect to proposed amendments to the Patent Act.


 

Sanro Zlobec

Sanro Zlobec is a partner in Smart & Biggar's Montreal office where he has almost 20 years of experience in assisting clients in the technology sector with navigating a variety of patent-related issues. His expertise enables him to assist clients in crafting and implementing global patent-based strategies to establish, defend and improve their market position. Through the application of creative solutions to real-life problems, Sanro has assisted a broad range of companies, from high-tech start-ups to multinational enterprises, in a variety of technologies including telecommunications, digital imaging, semiconductor electronics, e-commerce and gaming. In addition, Sanro frequently appears before audiences in the context of continuing education seminars, and is involved in cultivating IP awareness amongst several Canadian non-profit trade associations.



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