## Facts

- Harvard College developed a method to create genetically modified mice that carry an activated oncogene, making them highly susceptible to cancer for research purposes.
- The method involved injecting the oncogene into fertilized mouse eggs, implanting the eggs into a host mouse, testing offspring for the gene, and breeding “founder” mice to produce transgenic progeny (“oncomice”).
- Harvard filed a patent application claiming (1) the process for producing the transgenic mice and (2) the resulting animals, drafted broadly to cover founder mice, their progeny, and non-human mammals produced using the technique.
- The Commissioner of Patents allowed the process claims but refused the product claims on the ground that higher life forms are not an “invention” under the Patent Act.
- The Federal Court (Trial Division) upheld the refusal; the Federal Court of Appeal reversed and ordered that the product claims be granted.
- The Supreme Court of Canada granted the Commissioner’s appeal by a 5–4 vote, restoring the refusal of the product claims.

## Issues

1. Whether a genetically engineered “higher life form” (a transgenic mouse) falls within “manufacture” or “composition of matter” in the Patent Act’s definition of “invention.”
2. What role, if any, administrative deference to the Commissioner plays in determining the statutory scope of patentable subject matter.

## Decision

- The Supreme Court allowed the Commissioner’s appeal and reinstated the refusal of the product (animal) claims.
- The Court held that higher life forms are not included within “manufacture” or “composition of matter” and therefore are not patentable as “inventions” under the Patent Act.
- The Court left intact the allowance of the process claims for producing the transgenic animals.
- In dissent, four justices would have held the oncomouse patentable as a “composition of matter,” absent an express statutory exclusion.

## Legal Principles

- Patentable subject matter turns on statutory interpretation of the Patent Act’s definition of “invention,” read in its ordinary meaning and legislative context.
- “Manufacture” and “composition of matter” do not extend to complex, self-directed, sentient higher life forms whose characteristics are not fully reducible to their engineered genetic material.
- A line may be drawn between lower life forms (which can more readily fit within traditional patent categories) and higher life forms, where extending patentability raises policy and administrability problems not clearly addressed by the Act.
- Major expansions of patentable subject matter with significant ethical, social, and economic implications are for the legislature to authorize explicitly.
- The Court treated the core question—scope of “invention”—as one for the court to decide as a matter of statutory meaning rather than by deference to administrative refusal.

## Conclusion

The Supreme Court of Canada held that genetically engineered higher life forms, such as the oncomouse, are not patentable “inventions” under the Patent Act, while confirming that processes for creating such organisms may be patented; any extension of patent protection to higher life forms requires clear legislative action.


Harvard College v. Canada (Comm’r of Patents), [2002] 4 S.C.R. 45 (Can. 2002)