Devin Doyle is a J.D. candidate at Osgoode Hall and is taking the Patent Law course.
The onset of genetic modification has generated an entirely new set of issues and problems in relation to patent law. One recent bone of contention in Canada has been determining which life forms can qualify as inventions, and therefore, which are eligible for patent protection. The Patent Act defines an invention as “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter”.
Many countries, including the US, have taken an inclusive approach, allowing various life-forms to be patented. The Supreme Court of Canada has expressed an opposing opinion, but has seemingly failed to accurately follow its own precedents.
The 2002 Supreme Court decision, Harvard College v. Canada (Commissioner of Patents), was a landmark case in Canadian patent law. Harvard College sought a patent for a genetically modified mouse (and for all similarly modified non-human mammals) which was valuable in cancer research. In 1992, Patents for the “Oncomouse” (as it was termed) were issued to Harvard College from both the United States Patent Office and the European Patent Office (Harvard College, supra at para. 34). Ten years later, the Supreme Court of Canada denied similar protection in Canada. Although patents were issued in Canada with respect to the genetic alteration process, no patents were issued for the end result – the genetically modified mouse itself.
Writing for the majority, McLachlin J. placed significant weight on an undefined distinction between lower and higher life forms, ultimately concluding that higher life forms are not patentable because they do not fall within the definition of invention in s. 2 of the Patent Act. In particular, the Court held that higher life forms “transcend the particular genetic material of which they are composed” (para 163) and thus do not qualify as manufactures or compositions of matter pursuant to s. 2.
Two years later, the Supreme Court revisited the topic of patentability of higher life-forms in Monsanto Canada Inc. v. Schmeiser. In this case, Monsanto held a patent for a genetically modified plant cell and the case dealt with an infringement claim based on Schmeiser’s “use” of canola plants which contained the patented gene. Once again, the Court split 5-4. This time, however, the majority ruled in favour of patent protection.
Pursuant to the ruling in Harvard College, plants are “higher life forms”, and therefore, are not patentable. Giving patent protection for an entire plant based on a patent for a single gene runs contrary to, as Arbour J put it, the “reasonable expectation that plants, as unpatentable subject matter, fall outside the scope of patent protection” (para. 160). Nonetheless, the Court held that Schmeiser was prohibited from using certain canola plants and seeds because “where a defendant’s commercial or business activity involves a thing of which a patented part is a significant or important component, infringement is established” (para 78). In effect, the Court extended patent protection of the single gene to prohibit use of any canola plants which may contain the gene.
Upon careful examination, Monsanto seems to directly contradict the ruling in Harvard College. Without actually saying so, the Supreme Court effectively patented a plant – something it held to be unpatentable only two years previously. If one was to apply the majority’s reasoning from Monsanto to the Oncomouse, Harvard College would effectively have patent protection over the mouse itself. Even though the Oncomouse is not technically covered by patent protection, any “use” of the mouse would include “use” of the underlying process and genes. Correspondingly, use of the mouse itself would be prohibited, effectively giving patent protection to the Oncomouse. This is in direct contradiction of the majority’s ruling in Harvard College. For all practical purposes, the ruling in Monsanto holds that if you can get a patent for a plant/animal gene, you effectively get a patent for the respective plant/animal itself.
If Canada issues patents on the process, but not on the end product, this opens the door to potential impropriety and the possibility of parties circumventing patent protection. As mentioned by the dissent in Harvard College: “Some patents for processes may be of little practical value… competitors who are able to get their hands on the organism need not repeat the process of producing it. What is needed is a patent for the organism”. Looking at commercial and scientific realities, the extension of patent protection to certain higher life forms makes sense. It would be unreasonable to allow people to bypass patent protection simply by breeding genetically modified mice together instead of using the (likely more expensive) patented scientific process. If the Supreme Court is willing to extend protection to higher life forms indirectly, it may as well allow the issuance of patents for them in the first place.
The Court’s trepidation of allowing patents for higher lifer forms is quite possibly due to the moral objections or fear of public outcry rather than due to its technical interpretation of the Patent Act. This is the domain of the democratically elected legislature, which needs to step in and update the Patent Act. The definition of “invention” in s. 2 of the Patent Act should be expanded to include various life forms. This is not inconsistent with the common law since patent protection has effectively already been granted for higher life forms. Creating a uniform standard would clear up much of the current controversy and decrease uncertainty in both the business and scientific communities.
I agree that legislative reform can bring the certainty, which is a defining characteristic of patent law. However in the area of higher life forms (“HLF”), legislative reform should acknowledge that flexibility is required and legislatures should explicitly allow for judicial discretion, which has already seeped into the system. Indeed, the lack of definition in the Canadian Patent Act as to what encompasses a HLF and the legislature’s reluctance to provide a precise definition has placed the task of deciding the patentability of higher life forms squarely on the shoulders of the court system. The contradictory decisions of Harvard College v. Canada (Commissioner of Patents) (“Harvard College”) and Monsanto Canada Inc. v. Schmeiser (“Monstanto”) depicts the debate that has likely prevented the legislatures from taking a firms stance on the issue of higher life form patentability.
What is common in both decisions however seems to be the attention to public policy and the Supreme Court’s willingness to interpret the Patent Act based on policy concerns. In the Harvard College decision, Bastarache held that the Oncomouse is not patentable as the words “machine”, “manufacture” and “composition of matter” are not synonymous with a conscious, sentient living creature (para 161). It can however be argued that taken literally, “composition of matter” can be synonymous with a living creature such as the mouse which is obviously composed of matter. Regardless of interpretation, it can be suggested that the Supreme Court’s introduction of an exclusion for sentient living creatures since it “raises a number of extremely complex issues”(para 166) is a precursor to the reasons given by the US Patent and Trademark Office (USPTO) in rejecting the Newman-Rifkin claim. There the application for a chimeric cross between the DNA of a human and another mammal was denied for the reason that it would be indirect slavery: by allowing the patent holder to have exclusive rights over the use of the animal, its procreation and its offspring. In this way, HLFs are denied patentability not because they are explicitly excluded by the legislature but because the consequences of such patents can run counter to other policy objectives: such as the autonomy of these life forms. At the USPTO noted: “[I]nventions directed to human/non-human chimera could, under certain circumstances, not be patentable because, among other things, they would fail to meet the public policy and morality aspects of the utility requirement.” (see: http://www.nature.com/nbt/journal/v24/n5/full/nbt0506-517.html#B1 and http://www.uspto.gov/news/pr/1998/98-06.jsp). While during class discussion, we noted that the patent system has become more secular in its considerations, the debate over HLFs may not have escaped moral judgments when interpreting the text of the Patent Act. While the decision in the Monsanto case seems to suggest otherwise, I argue that this decision too is in line with considerations outside the mere boundaries of the Patent Act.
Indeed as patent law practitioners Cynthia Tape and Connor McCourt note in their article “Supreme Court Kills Harvard Mouse”, one of the ramifications of the Harvard decision was that it made Canada look like “an unfriendly environment for biotechnology investment and development”(see: http://www.torys.com/Publications/Documents/Publication%20PDFs/ARTech-30T.pdf). As Canada’s trading partners granted such patents for plants and animals, its unavailability in Canada could risk investor contribution. It is unclear to what extent these economic concerns affected the judgement of the Supreme Court but it is an influence that can inform the policy debate over potential legislative change.
As is noted in the conclusion of the above post, legislative change would be beneficial in clarifying the issue of HLF patentability. This change can be short term through explicit exclusions or additions or long term by inserting a phrase into the Act that recognizes the policy concerns that a court can take into consideration when deciding on new forms of patentable subject matter. While this latter suggestion may diminish the certainty that exists in the Patent Act, its inclusion would acknowledge the broader interpretations that the courts have already indirectly involved themselves in as well as the growth and flexibility required in an area of law that is anything but certain.
It is not logical that we deny a patent on a product that can legally be sold. A mouse can be sold, but is not patentable.
If it is morally repugnant that a higher life form may be patented, how can it be acceptable that it may be bought and sold, and live and die at the whim of its owner? Putting that troubling thought process aside…
…If the Patent Act is amended to forfend against the problem of commerce in higher life forms, the wording could tie patentability to legal sales in this Country (Canada). Thus a human would not be patentable (because a human cannot be bought and sold), but a mouse would.
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