Intellectual Property Rights

Harvard College v. Canada (Commissioner of Patents)

2002 SCC 76; [2002] 4 SCR 45

Citation: 2002 SCC 76; [2002] 4 SCR 45
Court: Supreme Court of Canada
Date: 5 December 2002
Bench: Full Court; Bastarache J. delivered the majority judgment

Facts

Harvard researchers genetically altered mice by inserting an oncogene into an early-stage mouse embryo.
The resulting mice had an increased tendency to develop cancer.
These animals became known as the Harvard Oncomouse.
The invention was intended to assist cancer research and testing.
Harvard’s patent application contained:
process claims;
claims to genetically altered cells;
claims to the entire genetically altered mouse and its descendants.
The Canadian Patent Commissioner allowed certain process and lower-level biological claims.
However, claims to the whole mouse were rejected.
The dispute reached the Supreme Court of Canada.

Issue

Whether a genetically engineered higher life form is an “invention” under the Canadian Patent Act.
Whether a mouse can be classified as a “manufacture” or “composition of matter.”
Whether patent protection for such organisms should be recognised judicially or left to Parliament.

Rule

Patent legislation must be interpreted according to its statutory language.
Patentable subject matter included an:
art;
process;
machine;
manufacture; or
composition of matter.
“Manufacture” generally refers to a non-living product made through human-controlled production.
“Composition of matter” ordinarily refers to ingredients or substances combined by a person.
A distinction may be drawn between:
lower life forms, such as microorganisms or cells; and
higher life forms possessing complex biological organisation.
Courts should be cautious about extending patent monopolies into areas involving major social, ethical and regulatory consequences without clear legislative direction.

Application

The Oncomouse was undeniably produced through substantial human scientific intervention.
Nevertheless, the majority focused upon whether the entire animal fell within the statutory categories chosen by Parliament.
A mouse is not simply assembled from components in the manner of an ordinary manufactured article.
Once genetic material is introduced, natural biological processes govern:
development;
growth;
organ formation;
reproduction;
behaviour.
The researchers did not exercise complete control over every characteristic of the resulting animal.
The majority therefore found the word “manufacture” unsuitable for a complete higher life form.
It similarly rejected “composition of matter.”
Although an animal consists of matter, the expression was understood as referring to a material mixture or substance rather than an integrated living organism.
The Court distinguished lower-level biological material.
Genetically modified cells and the processes used to create the animal could fall within patentable categories because they were more directly controlled and produced by human intervention.
The majority also considered the broader consequences of recognising animal patents:
ownership over reproduction;
farmers’ and researchers’ rights;
animal welfare;
environmental concerns.
Such questions supported the conclusion that Parliament should expressly decide whether higher life forms were patentable.
The dissent viewed the statutory terms more broadly and considered the engineered mouse a human-made composition, but that position did not prevail.

Conclusion

The Supreme Court of Canada held that the Oncomouse, as a complete higher life form, was not patentable under the existing statutory categories.
Claims to the process and certain genetically altered cells could remain valid.
The Court left any broader extension to higher life forms for legislative decision.
Use this case for: a genetically modified higher life form was held outside “manufacture” and “composition of matter,” although processes and lower-level biological components could be patented.