The Supreme Court of Canada Finds Higher Life Forms Not Patentable Subject Matter

© 2003, Deeth Williams Wall LLP. All Rights Reserved. By: Lenni Carreiro (March 19, 2003)

In a 5:4 split decision, the majority of the Supreme Court of Canada recently ruled in Harvard College v. Canada (Commissioner of Patents) ⁱ that a genetically altered mouse ("the oncomouse") was not patentable subject matter. Canada is now one of the few jurisdictions which have refused to provide patent protection to the oncomouse. Patent protection has been extended to the oncomouse in numerous jurisdictions such as Australia, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden, the United Kingdom and the United States. Similar patents have been provided in Japan and New Zealand.

In the 1980's, the respondent, Harvard College ("Harvard") applied for a patent for an oncomouse - a mammal genetically altered to carry a cancer-promoting gene referred to as an "oncogene". According to the application, an oncogene is injected into fertilized mouse eggs and the eggs are then subsequently implanted into a host female mouse and allowed to develop to term. The offspring who carry the oncogene are termed "founder" mice. Founder mice are then mated to unaltered mice and fifty per cent of the resulting offspring carry the oncogene in all their cells.

Harvard's patent application claimed both the process for generating the mouse and the resulting product, the oncomouse itself. The patent Examiner allowed the process claims, but refused the product claims. The refusal was confirmed by the Commissioner. Harvard's later appeal to the Federal Court, Trial Division was dismissed; however, its further appeal to the Federal Court of Appeal was allowed.

The central issue in the appeal was whether the definition of invention encompassed the oncomouse, a higher life form. Section 2 of the Canadian Patent Act ⁱⁱ provides as follows:

"invention" means 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.

In assessing whether the oncomouse fell within the definition of invention, the Court considered whether the words "manufacture" or "composition of matter" as described in section 2 of the Act, were sufficiently broad enough to encompass higher life forms. The remaining categories of invention namely, art, process and machine, were viewed as inapplicable to claims directed toward a genetically engineered higher life form.

In interpreting the statute, Bastarache J., writing for the majority, read the words of the Act "in their entire context and in their grammatical and ordinary sense harmoniously with the scheme of the Act, the object of the Act, and the intention of Parliament" ⁱⁱⁱ.

With respect to the definition of invention, although Bastarache J. conceded that the definition was broad enough to include "unforeseen and unanticipated technology" ^iv, the definition was exhaustive and did not include "anything under the sun that is made by man" ^v.

Referring to a dictionary definition of the term "manufacture" which defined the term as "an action or process of making articles or material by the application of physical labour or mechanical power" ^vi the court reasoned that the term did not extend to higher life forms since the term denotes a "nonliving mechanistic product or process" ^vii. Moreover, according to the majority, higher life forms could not be characterized as something made by the hands of man.

The category of "composition of matter" was also viewed as not including higher life forms. Although the phrase was considered broader than "manufacture", the categories associated with the phrase in section 2, restricted the category to the same genus as the others. Accordingly, since "machine" and "manufacture" did not imply a conscious, sentient life form, "composition of matter" also did not. The dictionary definitions of the terms "composition" and "matter" supported this interpretation.

According to the majority, this interpretation was also supported by the failure of the scheme of the Act to address adequately the various concerns raised by the patenting of higher life forms. For instance, the concern that the patenting of higher life forms would lead to the patenting of human life was real since the application of the Charter of Rights and Freedoms could not justify an exception.

One further concern discussed by the majority was the ability of higher life forms to self-replicate, which was seen as broadening the scope of the patent to extend to not only the higher life form itself but also to its progeny. The potential impact of this increased scope of protection on the agricultural industry was noted. Since such concerns were not sufficiently addressed, the majority reasoned that parliament did not intend higher life forms to be patented.

Similarly, the object of the Act did not expand the definition of invention to permit the patenting of higher life forms. According to the majority, although the Act's objective is to "advance research and development and to encourage broader economic activity" ^viii, not all innovations are patentable.

The court also found guidance in the Plant Breeders' Rights Act ^ix which provides a legislative scheme for plant varieties. In the 90's the Act was passed subsequent to a Supreme Court decision which failed to adequately address the issue of whether plants were patentable. Since the patentability of other higher life forms was not addressed at the time the Plant Breeders' Rights Act was enacted, the majority reasoned that the adoption of the Act signified that higher life forms were not patentable subject matter.

In its reasoning the majority also discussed the arbitrary line in Canadian patent law between lower and higher life forms. In Canada, lower life forms such as microorganisms have been patentable for some time. The court justified the distinction between the patentability of lower life forms and higher ones on the basis of the "common sense differences between the two" life forms ^x. That is, "patentable micro-organisms are formed in such large numbers that any measurable quantity possess uniform properties and characteristics" ^xi whereas the same cannot be said for plants and animals. Given the unique concerns raised by the patentability of plants and animals, the court held that it was Parliament's responsibility to alter the line currently drawn.

In sum, in Canada lower life forms continue to be patentable whereas higher life forms, such as plants and animals, are not. Although the court explicitly stated that plants and animals are "higher life forms", the court failed to define the category precisely, leaving the issue of what life forms fall within the "higher" category open for debate.

The result is somewhat confusing since the Commissioner of Patents issued a patent for Monsanto's genetically modified, "ROUND-UP READY" canola which was recently before the Federal Court of Appeal. However, in that patent the broadest claims are directed to genetically modified plant cells rather than the entire plant. Notwithstanding the difference in language, there appears to be little practical difference between the two types of claims.

In time, the effect of this decision on the biotechnology community in Canada will be demonstrated. There are differences in opinion regarding the necessity of patents in the industry. If patents are truly required for the success of the biotechnology industry, this decision will hurt the industry here in Canada. Whether the federal government steps up to address this issue, in accordance with the Supreme Court's suggestion, remains to be seen.

Does this give any hint of the SCC's approach to patenting new forms of technology, for instance, business methods?

Endnotes

Contact Clare McCurley for more information on on the Patentability of Life Forms in Canada.