Court rules that higher life forms cannot be patented in Canada

President and Fellows of Harvard College vs. Commissioner of Patents
(December 05, 2002)

The Supreme Court of Canada has recently reversed a Federal Court of Appeal ruling that patenting higher life forms is permissible under the Canadian Patent Act.

In a majority decision, Canada's Supreme Court ruled that Harvard University cannot patent in Canada, a mouse genetically altered to develop cancer. The Court said the mouse (a "higher life form") was not patentable because it is not a "manufacture" or "composition of matter" within the meaning of "invention" under Section 2 of the Canadian Patent Act, 1869. The Court conceded, at same time, that the 133-year-old Act was not designed to deal with living mammals such as mice and urged Canada's government to address the issue in Parliament.

The mice were not patentable, as a higher life form is not a "manufacture" or "composition of matter" within the meaning of invention under section 2 of the Patent Act. The body of a mouse does not consist of ingredients or substances that have been combined by a person. "Matter" captures only one aspect of a higher life form, which is regarded as possessing qualities and characteristics transcending the genetic material it is composed of. The patenting of higher life forms involves a radical departure from the traditional patent regime, and the patentability of such forms is highly contentious. As a result, clear and unequivocal legislation is required for higher life forms to be patentable.

The "oncomouse," named for oncology, the study of cancer, was developed by Harvard's medical school in 1984. The "oncomouse" patent was granted in the U.S. in 1988, and is protected in Australia, Japan and several European countries. The invention which is titled "transgenic animals", claims a process by which a cancer-promoting gene (oncogene) is injected into fertilized mouse eggs which when implanted into a female host mouse will result in offspring containing the oncogene (founder mice). Fifty per cent of the offspring resulting from mating of these genetically altered founder mice with normal mice would have the oncogene, making them suitable for animal carcinogenic studies. The Harvard "oncomouse" patent claims both process and product and extends to all non-human mammals. The Canadian Patent Office allowed the process claims but rejected the product claims. The Supreme Court decision resulted from Harvard's action to appeal for the product claims.

The modified mice are used by universities and commercial labs to study cancer and its various treatments. The patents give Harvard exclusive rights to create the mice and charge licensing fees to scientists who use them for research. In Canada, others could obtain the altered mice and breed them for research purposes without paying Harvard a fee. Canadian law, however, does allow patents on certain bacteria, single-celled organisms, plants and agricultural crops.