Harvard College v. Canada (Commissioner of Patents)
citation(s): 2002 SCC 76,  4 SCR 45; online
Held: A higher life form is not patentable because it is not a “manufacture” or “composition of matter” within the meaning of “invention” in s. 2 of the Patent Act.
Bastarache J (5-4 majority):
Binnie J (dissenting):
at para 6:
The issue, in the words of s. 2 of the Patent Act, is whether the oncomouse that has been produced by a combination of genetic engineering and natural gestation is a “composition of matter” that is new, unobvious and useful. If it is, then the President and Fellows of Harvard University, who funded the research, are entitled to a patent.
at para 7:
[Harvard College’s] sole claim is to have modified what my colleague describes as the “genetic matter of which [the oncomouse] is composed”, as described in the disclosure portion of the patent application:
(i) the desired oncogene is obtained from the genetic code of a non-mammal source, such as a virus;
(ii) a vehicle for transporting the oncogene into the mammal’s chromosomes is constructed using a small piece of circular bacterial DNA referred to as a plasmid; the plasmid is chemically cut and the oncogene is chemically “spliced” into the plasmid;
(iii) the plasmid containing the oncogene is then mechanically injected into fertilized eggs at a site called the male pronucleus;
(iv) the eggs are then implanted in a host mammal or “foster mother”;
(v) the eggs are permitted to develop and the offspring are delivered by the foster mother;
(vi) after delivery, the offspring are tested for the presence of the oncogene; the offspring that contain the oncogene are called “founder” animals;
(vii) founder animals are subsequently mated with ordinary animals and the offspring are again tested for the presence of the oncogene before the offspring are used in research.
at para 3 (per Binne J, dissenting):
If Canada is to stand apart from jurisdictions with which we usually invite comparison on an issue so fundamental to intellectual property law as what constitutes an “invention”, the respondent, successful everywhere but in Canada, might expect to see something unique in our legislation. However, one looks in vain for a difference in definition to fuel the Commissioner’s contention that, as a matter of statutory interpretation, the oncomouse is not an invention. The truth is that our legislation is not unique. The Canadian definition of what constitutes an invention, initially adopted in pre-Confederation statutes, was essentially taken from the United States Patent Act of 1793, a definition generally attributed to Thomas Jefferson. The United States patent on the oncomouse was issued 14 years ago. My colleague, Bastarache J., acknowledges that the fertilized, genetically altered oncomouse egg is an invention under our Patent Act, R.S.C. 1985, c. P-4 (para. 162). Thereafter, we part company, because my colleague goes on to conclude that the resulting oncomouse, that grows from the patented egg, is not itself patentable because it is not an invention. Subject matter patentability, on this view, is lost between two successive stages of a transgenic mouse’s genetically pre-programmed growth. In my opinion, with respect, such a “disappearing subject-matter” exception finds no support in the statutory language.
at para 158 (per Bastarache J):
I agree that the definition of “invention” in the Patent Act is broad. Because the Act was designed in part to promote innovation, it is only reasonable to expect the definition of “invention” to be broad enough to encompass unforeseen and unanticipated technology. I cannot however agree with the suggestion that the definition is unlimited in the sense that it includes “anything under the sun that is made by man”. In drafting the Patent Act, Parliament chose to adopt an exhaustive definition that limits invention to any “art, process, machine, manufacture or composition of matter”. Parliament did not define “invention” as “anything new and useful made by man”. By choosing to define invention in this way, Parliament signalled a clear intention to include certain subject matter as patentable and to exclude other subject matter as being outside the confines of the Act. This should be kept in mind when determining whether the words “manufacture” and “composition of matter” include higher life forms.
at para 162 (per Bastarache J):
First, the Oxford English Dictionary, supra, vol. III, at p. 625, defines the word “composition” as “[a] substance or preparation formed by combination or mixture of various ingredients”, the Grand Robert de la langue française, supra, vol. 2, at p. 367, defines “composition” as [translation] “[a]ction or manner of forming a whole, a set by assembling several parts, several elements”. Within the context of the definition of “invention”, it does not seem unreasonable to assume that it must be the inventor who has combined or mixed the various ingredients. Owing to the fact that the technology by which a mouse predisposed to cancer is produced involves injecting the oncogene into a fertilized egg, the genetically altered egg would appear to be cognizable as “[a] substance or preparation formed by combination or mixture of various ingredients” or as [translation] “[a]ction or manner of forming a whole … by assembling several parts”. However, it does not thereby follow that the oncomouse itself can be understood in such terms. Injecting the oncogene into a fertilized egg is the but-for cause of a mouse predisposed to cancer, but the process by which a fertilized egg becomes an adult mouse is a complex process, elements of which require no human intervention. The body of a mouse is composed of various ingredients or substances, but it does not consist of ingredients or substances that have been combined or mixed together by a person. Thus, I am not satisfied that the phrase “composition of matter” includes a higher life form whose genetic code has been altered in this manner.