This section contains the nature of the case and procedural background.

Harvard applied for a patent on “transgenic animals”. A cancer‑promoting gene (oncogene) is injected into fertilized mouse eggs as close as possible to the one‑cell stage. The eggs are then implanted into a female host mouse and permitted to develop to term. Offspring are tested for the presence of the oncogene. Those with the oncogene are mated with mice that have not been genetically altered. Fifty percent of the offspring will have all of their cells affected by the oncogene, making them suitable for animal carcinogenic studies. Harvard applied for a patent to protect the process and the mice whose cells contain the oncogene. Harvard also made process and product claims to all non‑human mammals. The process claims were allowed but the product claims were rejected. The Commissioner confirmed the refusal of the product claims. The Federal Court, Trial Division, dismissed Harvard’s appeal. An appeal to the Federal Court of Appeal was allowed. The Federal Court of Appeal overturned. The Commissioner appealed.

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