In a 5:4 decision released December 5, 2002, the Supreme Court of Canada has ruled that a genetically modified mammal is not patentable subject matter under the Canadian Patent Act.
The patent application at the center of the proceedings contains claims to a transgenic, non-human mammal, colloquially referred to as the "Harvard Mouse" or the "oncomouse". The preferred embodiment of the invention is a laboratory mouse, whose genes have been modified to increase its susceptibility to cancer. Claims 1-12 of the application, the claims to the transgenic mammal, were rejected by the Commissioner of Patents in August of 1995 as being directed to non-patentable subject-matter. The remaining claims of the application, including claims to methods of producing the transgenic mammals and transgenic cell cultures, methods of testing materials suspected of being carcinogens using the transgenic mammals, and various plasmids and somatic cell cultures were found to be allowable during prosecution.
An appeal to the Federal Court Trial Division was dismissed. On a further appeal to the Federal Court of Appeal, it was held in a 2:1 decision that claims 1-12 of the application were patentable under the Canadian Patent Act.
The reasons of the majority of the Supreme Court were written by Justice Bastarache. Central to the majority's decision is an extensive review of the definition of "invention" in the Patent Act, and an assessment as to whether a higher life form is a "manufacture" or "composition of matter" as those terms are used in that definition.
The analysis commences with a review of the words of the Act. The majority finds that while the words used in the definition of invention are broad, it does not follow that the definition encompasses "anything new and useful made by man" -- an expression referred to by the U.S. Supreme Court during its analysis of the corresponding definition in the U.S. Patent Act. The majority notes that the Canadian definition is exhaustive, signaling a clear intention by Parliament to include certain subject matter as patentable, and to exclude other subject matter.
After a review of the definitions of "manufacture" and "composition of matter" the Court concludes that higher life forms do not fit within these terms. Moreover, in the majority's view, the patenting of higher life forms would involve a "radical departure" from the traditional patent regime in Canada, requiring an "unequivocal direction from Parliament."
The majority next reviews the scheme of the existing Patent Act. It finds that the patenting of higher life forms raises "unique concerns" which do not arise with respect to non-living inventions and which cannot be addressed by the scheme of the Act. Concerns considered by the Court include the ability of higher life forms to self-replicate, the complexity of higher life forms, and the spectre of patents on humans. In the majority's view, the lack of direction within the current Patent Act to deal with such issues is further support for its position that higher life forms are not patentable.
The majority also reviews the object of the Patent Act. They accept that the object of the Patent Act is to encourage and reward the development of innovations and technology, which suggests that the definition of invention should be given a broad reading. However, the majority reiterates that Parliament chose an exhaustive definition for invention, and therefore not everything is to be patentable.
The majority also places some reliance on the existence of related legislation, namely, the Plant Breeders' Rights Act. In this regard, the majority finds that the existence of the plant breeders' legislation is some indication of legislative intent, and also demonstrates that mechanisms other than the Patent Act may be used to encourage inventors to undertake innovative activity in the field of biotechnology.
Finally, the majority expressly addresses the question of whether it is appropriate to draw a line between lower life forms and higher life forms, which would not be patentable in view of the majority's reasons. The majority acknowledges that lower life forms have been accepted as patentable by the Canadian Patent Office since the decision in Re Application of Abitibi Co. (1982), 62 C.P.R. (2d) 81, noting that the issue has never been litigated in Canada. The majority holds that the distinction between lower and higher life forms is not explicit in the Act, but is nonetheless defensible on the basis of "common sense differences between the two".
Three broad justifications for the distinction are offered.
First, the majority observes that micro-organisms are produced en masse as chemical compounds are prepared, and are prepared and formed in large numbers in which any measurable quantity can possess uniform properties and characteristics. According to the majority, the same cannot be said of plants and animals.
Second, the majority focuses on distinctions that can be made between animals (the subject-matter of the patent claims in issue) and lower life forms. The majority highlights the capacity to display emotion and complexity of reaction and to direct behaviour in a manner that is not predictable as stimulus and response, traits that it states are unique to animal forms of life.
Finally, the Court notes that the World Trade Organization's Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), and the North American Free Trade Agreement (NAFTA), each contain an article whereby members may "exclude from patentability" certain subject matter, including plants and animals other than micro-organisms. In the view of the majority, the fact that there is a specific exception in TRIPS and NAFTA for plants and animals does demonstrate that the distinction between higher and lower life forms is widely accepted as valid.
However, notwithstanding its efforts to justify the distinction between higher and lower life forms, the majority makes no effort to draw the line between (unpatentable) higher life forms and (patentable) lower life forms -- an exercise that will apparently be left to the Patent Office.
Four members of the Court concurred in dissenting reasons, written by Justice Binnie. While the law of Canada is now reflected in the majority's reasons, discussed above, it is interesting to note that the minority was highly critical of the majority's reasons, and in particular the distinction drawn by the majority between higher and lower life forms in terms of patentability.
On strict legal theory, it may be arguable that the decision does not exclude plants or lower, but multicellular, animals such as invertebrates from patentability. However, the majority's reasons are broadly worded, and assess issues underlying the patentability of the transgenic mammal that is the subject-matter of the claims, as well as other so-called higher life forms, such as plants. It is therefore unlikely that any higher life form, plant or animal, would be accepted as patentable under Canadian law by the Commissioner or any tribunal lower than the Supreme Court itself. In this regard, Canadian law has now fallen out of step with a number of other jurisdictions, including the United States, Europe and Japan where patents have been granted to Harvard for this invention.
As no further appeal is possible, the only remaining avenue for the patenting of higher life forms in Canada could be for Parliament to amend the Patent Act to expressly provide for their patentability.
In the immediate future, the Canadian patent profession will continue to explore effective ways of claiming genetically modified organisms short of claiming complete plants or animals.
A. David Morrow, Steven B. Garland and Colin B. Ingram of Smart & Biggar represented Harvard College in this appeal.