The Harvard Mouse case:
developments in the patentability of life forms

Angela Furlanetto
Dimock Stratton Clarizio LLP

On Dec. 5, 2002, the Supreme Court of Canada released its decision in President & Fellows of Harvard College v. Canada (Commissioner of Patents), [2002] SCC 76 (the Harvard Mouse case), one of the most significant decisions in Canadian patent history. In a 5-4 split, the Supreme Court found that a transgenic mouse, with cells genetically altered by a cancer-promoting gene (oncogene), was not patentable subject matter in Canada.

With its decision, the Supreme Court has challenged the legislature to address the issues associated with patenting higher life forms by amendment to the Patent Act. While we await the government’s reaction to this challenge, those practicing in the area of Canadian patent protection are required to investigate ways to claim genetically modified plants and animals and obtain the broadest protection possible without claiming the transgenic animal or plant itself.

The Harvard Mouse case arose from a patent application filed June 21, 1985 for a transgenic mouse whose genome was genetically altered by a cancer-promoting gene. The oncogene had been injected into fertilized mouse eggs and subsequently implanted into a female host mouse, which was then permitted to develop to term. The offspring of the host mouse was a “founder mouse” with all of its cells affected by the oncogene and could be mated with an uninjected mouse, to produce half of its offspring which had all of their cells affected by the oncogene. The altered mice were more susceptible to carcinogens and could be used for carcinogenic studies.

The Applicant of the patent, the President and Fellows of Harvard College, set out to protect the process for preparing the affected mice as well as the product of the process (the mouse itself). Claim 1 of the application, which was the broadest product claim read as follows:

“A transgenic non-human mammal whose germ cells and somatic cells contain an activated oncogene sequence introduced into said mammal, or an ancestor of said mammal, at an embryonic stage."

Claims to the method for the production of transgenic non-human mammals or transgenic cultures, the use of transgenic non-human mammals in methods of testing materials suspected of being carcinogenic, plasmids, and a somatic cell culture derived from a transgenic mammal, were allowed. The claims to the mouse were rejected by the Commissioner of Patents and Patent Appeal Board as being outside of the definition of an invention. This decision was upheld by the Federal Court Trial Division, but reversed on appeal.

Leave was granted to the Supreme Court on June 14, 2001. Four interveners were subsequently granted standing on the appeal:

1. The Canadian Council of Churches and the Evangelical Fellowship of Canada;
2. Canadian Environmental Law Association, Greenpeace Canada, Canadian Association of Physicians for the Environment, Action group on Erosion Technology and Concentration and the Canadian Institute for Environmental Law and Policy;
3. Sierra Club of Canada; and,
4. Animal Alliance of Canada, International Fund for Animal Welfare, Inc. and Zoocheck Canada Inc.

The sole question before the Supreme Court of Canada was whether the oncogenic mouse was a “manufacture” or “composition of matter” so as to fall within the definition of an invention under section 2 of the Canadian Patent Act. In reaching the decision that it did not, Justice Bastarache, writing for the majority, considered this issue from four perspectives: the meaning of the words “manufacture” and “composition of matter”; the scheme of the Patent Act; the object of the Patent Act; and other related legislation (The Plant Breeders’ Rights Act) which was previously enforced to specifically deal with one form of higher life form, the patenting of cross-bred plants.

In general, Justice Bastarache concluded that the patenting of higher life forms raises serious practical, ethical and environmental concerns, which are highly complex and beyond the scope of the judiciary. The issues involve policy concerns that are more appropriately left to Parliament, where the legislature can develop clear and unmistakable directions to deal with patenting of living subject matter and its acceptable and unacceptable limitations. Higher life forms are not contemplated by the current Patent Act and provide a radical departure from the traditional patent regime.

An “invention” is defined in section 2 of the Patent Act 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.”

Justice Bastarache began his analysis by examining the scope of the definition of the word “invention.” He concluded that while the definition is broad, it is not exhaustive. The word “manufacture” is commonly understood to refer to non-living mechanistic products or processes and not living matter. As for the phrase “composition of matter,” Justice Bastarache referred to the definition of “composition in the Oxford English Dictionary: “a substance or preparation formed by combination or mixture of various ingredients” and resolved that the oncomouse cannot be resolved in those 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.”

He also provided that “matter” is defined as “a physical or corporeal substance in general…contradistinguished from immaterial or incorporeal substance (spirit, soul, mind), and from qualities, actions, or conditions.” He concluded that as higher life forms are generally regarded as possessing qualities and characteristics that transcend the particular genetic material of which they are composed, they cannot be described as a “composition of matter.”

In order to address whether higher life forms fall within the scheme of the Patent Act, Justice Bastarache contrasted the special concerns of higher life forms to non-living inventions. He noted that biological inventions were living and self-replicating, incredibly complex, incapable of full description and contained important characteristics that had nothing to do with the invention. He reviewed the issues raised by the interveners and the Canadian Biotechnology Advisory Committee in its report in June 2002 as evidence of the complexity of the issues raised by patenting higher life forms. Such issues include: the impact on the agricultural industry in connection with the collection and reuse of seeds; issues associated with self-replication as it pertains to progeny and the boundaries regarding infringement of rights; concerns that patents to life forms might deter further innovation in the biomedical field; and the concerns associated patenting human life, tissues, and organs.

He concluded that these issues clearly show that patenting higher life forms raise serious concerns which are not covered by the scheme of the Patent Act and which are not be saved by the Charter.

Justice Bastarache acknowledged that the two central objects of the Patent Act were to advance research and development and to encourage broader economic activity. However, he concluded that these objects do not imply that “anything under the sun that is made by man” is patentable. Instead, he found that the language and scheme of the Act is not well suited to higher life forms and as such he surmised that Parliament did not intend for patent rights to extend to higher life forms.

In reaching his conclusions, Justice Bastarache refers to the Plant Breeders’ Rights Act (PBRA) as an example of legislation that was imposed by Parliament to address concerns associated with the patenting of crossbred plants.

The Federal Court of Appeal in Pioneer Hi-Bred Ltd. v. Commissioner of Patents [1987], 14 C.P.R. (3d) 491 (F.C.A.), ruled that higher plant life forms did not fall within the definition of an invention in the Patent Act. In that case, the Court was asked to consider claims to a new soybean variety resulting from cross-breeding. In reaching its decision that the invention should not be patentable, the Court stated the following regarding the patentability of plants:

“…speaking of the intention of Parliament given that plant breeding was well-established when the act was passed, it seems to me that the inclusion of plants within the purview of the legislation would have led first to a definition of invention in which words such as “strain”, “variety” or “hybrid” would have appeared, and second, to the enactment of special provisions capable of better adapting the whole scheme to a subject-matter, the essential characteristic of which is that it reproduces itself as a necessary result of its growth and maturity. I do not dispute the appellant’s contention that those who develop new types of plants by cross-breeding should receive in this country, as they do elsewhere, some kind of protection and reward for their efforts but it seems to me that, to assure such result, the legislator will have to adopt special legislation, as was done a long time ago in the United States and in many industrialized countries.”

In 1989, the Supreme Court of Canada dismissed Pioneer Hi-Bred’s appeal of this decision, on the basis that the patent for the new soybean variety was invalid as comprising insufficient disclosure to support its claims. The Supreme Court did not comment on whether the new soybean variety would fall within the definition of invention under section 2 of the Patent Act.

Shortly thereafter in 1990, the PBRA was enforced. The PBRA provides protection for propagating material (the seed and the cuttings) pertaining to new plant varieties. It does not provide protection for the actual plant, nor does the right prevent the development of different plant varieties from protected plants or the use of seeds from protected varieties.

Justice Bastarache rationalized that the Plant Breeders’ Right Act was implemented in order to recognize that plant varieties deserved some form of intellectual property protection. It did not however answer the question of the patenting of higher life forms. He instead concluded that only Parliament was in the position to respond to the concerns associated with the patenting of all higher life forms. If it chose to do so, it would need to create a complex legislative scheme similar to the PBRA, or make amendments to the Patent Act.

The decision of the majority was opposed by a strong dissent, written by Justice Binnie.

Several of the arguments raised by Justice Binnie suggest that there is strong support that some form of intellectual property right should be afforded to higher life forms.

Justice Binnie argued that it is an extraordinary scientific achievement to permanently genetically alter the genes of an animal where that alteration did not arise in nature. He rationalized that just as other forms of invention such as moon rockets, antibiotics, telephones, e-mail or hand-held computers, which would not have been anticipated at the time the Patent Act was drafted, would be considered inventions, so too should genetic engineering of higher life forms. He noted that corresponding patent applications for the invention were issued in a handful of countries around the world, including the United States, the United Kingdom and Japan. Accordingly, Justice Binnie argued that a comparable jurisdiction such as Canada with comparable intellectual property legislation, should arrive at a similar legal result.

As a matter of law, Justice Binnie argued that the Patent Act provides that there can be no patent for a human being. However, the Act does not distinguish between lower and higher life forms. This distinction, Binnie suggested is arbitrary and unwarranted.

The decision in Harvard Mouse will no doubt encourage the legislature to implement an amendment to the Patent Act, which carves out the acceptable and unacceptable limitations for patenting life forms. Until then, applicants should focus their attention on patenting the process and uses of their genetic inventions and the product of genetic alterations at the cell or gene level.

The scope of protection available for claims to a gene or cell has not yet been fully determined in the context of a patent directed to a transgenic animal. If the Federal Court of Appeal decision in Monsanto v. Schmeiser [2001] FCT 256 is any indication, such claims may be sufficient to protect the patentee from infringing use of the transgenic animal. This issue however may be further clarified if the Supreme Court of Canada grants leave in Monsanto v. Schmeiser and/or if another challenge is brought before the Court.