Harvard College v. Canada (Commissioner of Patents) 3 S.C.R. 519, 2002 SCC 68 is a leading Supreme Court of Canada case concerning the patentability of higher life forms within the context of the Patent Act.Patent Act, RSC 1985, c P-4 At issue was the patentability of the Harvard oncomouse, a mouse that had its genome genetically altered by a cancer-promoting gene (oncogene). In a 5-4 split, the Canadian Supreme Court held that the oncomouse and higher life forms in general are not patentable subject matter in Canada.
Background Harvard College researchers (the respondents) developed a process by which they could create transgenic animals whose genomes are altered by a cancer-promoting gene (called an activated oncogene).Harvard College 4 SCR 45 at para 123 The researchers injected the oncogene into fertilized mouse eggs close to the one-cell stage and implanted them into a female host mouse where they developed to term.Harvard College 4 SCR 45 at para 122 The resulting offspring were then tested for the presence or absence of the oncogene. Those with the gene are referred to as "founder" mice and are mated with unaltered mice. Offspring that contain the oncogene and have every cell in their body affected (including germ cells and somatic cells) by it are referred to as oncomice. Oncomice are useful for carcinogenic studies as they are more susceptible to carcinogens.Harvard College 4 SCR 45 at para 121 Such mice can be given material suspected of being a carcinogen and if tumours develop, it is an indication that the material is carcinogenic.
Initial Patent Application and Trial In 1985, the President and Fellows of Harvard College applied for a patent for an invention called "transgenic animals." In particular, they applied for a process patent for the process by which they created the mice as well as a product patent for the end product of the process, namely the "founder" mice and the oncomice, offspring whose cells are affected by the gene. These patent claims also extend to all non-human mammals whose genomes have been altered in a similar manner. Patent applications on the oncomouse were filed in many countries including the United States, Canada, Europe (through the European Patent Office) and Japan.
In March 1993, the Patent Examiner rejected the product claims (Claims 1 to 12) on the grounds that higher life forms were outside the definition of "invention" in section 2 of the Canadian Patent ActPatent Act, RSC 1985, c P-4, s.2. and are therefore not patentable subject matter.Harvard College 4 SCR 45 at para 126 The process claims (Claims 13 to 26) were allowed.Harvard College 4 SCR 45 at para 125 In August 1995, the Commissioner of Patents and the Patent Appeal Board upheld the refusal to grant a patent for the product claims.Harvard College 4 SCR 45 at paras 130 This decision was upheld by the Federal Court, Trial Division,Harvard College 4 SCR 45 at para 135 but was overturned by a majority of the Federal Court of Appeal. The Commissioner of Patents appeals from that decision.
Federal Court of Appeal The majority of the court reversed the decision of the Federal Court and directed the Commissioner of Patents to issue a patent covering claims 1 to 12 of the Patent Application. Speaking for the majority, Rothstein J.A. emphasized the object of the Patent Act, which is to "promote the development of inventions in a manner that benefits both the inventor and the public."President and Fellows of Harvard College v. Canada (Commissioner of Patents), 4 FC 528 at para 106 He stated that the Commissioner has no discretion to refuse to grant a patent under s.40 of the Act and if a process or product satisfies the requirements of the Act, a patent must be granted.Harvard College 4 FC 528 at para 109 Additionally, the Patent Act does not explicitly exclude living organisms such as non-human mammals from the definition of "invention."Harvard College 4 FC 528 at para 123 The majority concluded that the oncomouse "must be considered to be the result of both ingenuity and the laws of nature"Harvard College 4 FC 528 at para 129 and is an invention within the meaning of s.2 of the Patent Act, as it is both unobvious and a new and useful "composition of matter."Harvard College 4 FC 528 at para 114
Isaac J.A. in dissent, approved of the approach taken by the Patent Examiner and concluded that the Commissioner of Patents must be aware of and take into consideration the public interest.Harvard College 4 FC 528 at para 54 He states that in a morally divisive case such as the one at hand, the court should defer to the Commissioner's decision to refuse to grant a patent.
Leave was granted to the Supreme Court on June 14, 2001.
Supreme Court Ruling The court found in favour of the government, ruling that higher life forms are not patentable. The opinion of the court was written by Bastarache J. with L'Heureux-Dubé, Gonthier, Iacobucci, and LeBel JJ. concurring. The sole question before the court was whether the words "manufacture" or "composition of matter," in the context of the Patent Act, are broad enough to encompass higher life forms such as the oncomouse.Harvard College 4 SCR 45 at para 146 The court found that they are not. Bastarache J. stated that the determination of the patentability of higher life forms such as the oncomouse is beyond the authority of the court and would be a massive change in the current patent regime. The majority indicated that as there are significant public policy concerns at play, Parliament is best suited to address this issue.Harvard College 4 SCR 45 at para 153
The Commissioner’s Power to Refuse a Patent under Section 40 Though the court believed that the Commissioner went beyond his powers in ruling against a patent on public policy reasons, the court came to the same conclusion in denying the patentability of higher life forms such as the oncomouse. The majority stated that s.40 of the Patent Act does not give the Commissioner any discretion to refuse to grant a patent on the basis of public policy considerations, echoing Pigeon J.’s statement in Monsanto Co. v. Commissioner of Patents.Monsanto Co. v. Commissioner of Patents, 2 S.C.R. 1108 at para 144 In terms of the standard of review, the majority believed that the question of whether higher life forms are included in the definition of "invention" in the Patent Act is reviewable on a correctness standard.Harvard College 4 SCR 45 at paras 148-150
The Definition of "Invention": Whether a Higher Life Form Is a "Manufacture" or a "Composition of Matter"
(a) The Words of the Act In s.2, 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." The majority concluded that although the definition of "invention" is broad, it does not include "anything under the sun that is made by man."Harvard College 4 SCR 45 at para 158
The majority held that the words "manufacture" and "composition of matter" are not sufficiently broad to include a higher life form such as the oncomouse.Harvard College 4 SCR 45 at para 155 The court is of the opinion that "manufacture" denotes "a non-living mechanistic product or process"Harvard College 4 SCR 45 at para 159 and does not imply a conscious, sentient living creature.Harvard College 4 SCR 45 at para 160 The majority determined that the meaning of "composition of matter" can be ascertained by reference to the meaning of the words or phrases associated with them and thus is best read as not including higher life forms.Harvard College 4 SCR 45 at para 161 The majority also referred to the Oxford English Dictionary definition of "composition" which is "a substance or preparation formed by combination or mixture of various ingredients" and concluded that the oncomouse cannot be understood in such terms.Harvard College 4 SCR 45 at para 162 They also emphasized that higher life forms have unique qualities and characteristics that transcend the particular genetic matter of which they are composed.Harvard College 4 SCR 45 at para 163
More generally, the court is of the opinion that allowing patents on higher life forms would involve "a radical departure from the traditional patent regime" and it is for to Parliament to determine whether higher life forms are patentable.Harvard College 4 SCR 45 at para 166
(b) The Scheme of the Act The majority determined that the Patent Act, in its current form, is "ill-equipped to deal appropriately with higher life forms as patentable subject matter" since biological life forms are living, capable of self-replication, incredibly complex, incapable of full description, and can contain important characteristics having nothing to do with the invention.Harvard College 4 SCR 45 at paras 167 and 184 Justice Bastarache identified some of the serious issues surrounding the patentability of higher life forms including: the agricultural impact on farmers who wish to save and reuse seeds,Harvard College 4 SCR 45 at para 171 the rights of the "innocent bystander," who may come into possession of a patented organism by virtue of its ability to self-replicate and thus be subject to an infringement action,Harvard College 4 SCR 45 at para 172 deterrence of biomedical research and innovation,Harvard College 4 SCR 45 at para 173 and the potential for the commodification of human life, tissues and organs.Harvard College 4 SCR 45 at paras 176-182
(c) The Object of the Act The majority stated that the two central objects of the Patent Act are "to advance research and development and to encourage broader economic activity."Harvard College 4 SCR 45 at para 185 Although those are broad objectives, they determined that Parliament did not leave the definition of "invention" open and neither the language nor scheme of the Act suit higher life forms.Harvard College 4 SCR 45 at para 187 Thus, they held that Parliament did not intend to extend Patent monopoly rights over inventions related to higher life forms.
(d) Related Legislation: The Plant Breeders’ Rights Act The majority used the fact that Parliament enacted the Plant Breeders’ Rights Act in the wake of the Supreme Court's decision in Pioneer Hi-Bred Ltd. v. Commissioner of Patents 3 F.C. 8 to bolster their view that Parliament did not believe the Patent Act was tailored to include higher life forms.Harvard College 4 SCR 45 at para 189 Bastarache J. stated that since Parliament enacted specialized legislation to deal with the issues surrounding crossbred plants, a subset of higher life forms, had they wished to extend patentability to other higher life forms, they would have likely done so at the time.Harvard College 4 SCR 45 at para 193
Drawing the Line: Is it Defensible to Allow Patents on Lower Life Forms While Denying Patents on Higher Life Forms? In response to the respondent's argument that drawing a line between lower and higher life forms is indefensible, Justice Bastarache stated that the line is "defensible on the basis of common sense differences between the two" and reiterates that a parliamentary response is necessary.Harvard College 4 SCR 45 at para 199 Moreover, he stated that the distinction can also be upheld because, unlike higher life forms, a lower life form can more easily be conceptualized as a "composition of matter" or "manufacture"Harvard College 4 SCR 45 at paras 201 and 203 and microbes can be mass-produced like chemical compounds and will possess uniform properties and characteristics.Harvard College 4 SCR 45 at para 202
Dissent