Harvard College v. Canada (Commissioner of Patents)

The President and Fellows of Harvard College (Harvard) (plaintiff) submitted a patent application for an oncomouse, a genetically altered rodent with increased susceptibility to cancer, rendering it useful for research. The patent application described the process by which a cancer-promoting gene (oncogene) is injected into fertilized mouse eggs and implanted into a host mouse. Offspring of the host mouse are tested for the oncogene and later used for cancer research. Harvard intended to patent both the process of producing oncomice and the oncomice produced from the genetic alteration. Harvard also extended the patent claims to cover all non-human mammals. The Patent Examiner rejected the patent, concluding that higher life forms are outside the definition of “invention” in § 2 of the Patent Act of 1985 (Act), and therefore are not patentable subject matter. The Commissioner of Patents and Trial Division of the Federal Circuit affirmed the Patent Examiner’s decision, but the Federal Court of Appeal overturned. On appeal, Harvard contended that the language of the Act should be read broadly in light of the Act’s goal of encouraging innovation. Harvard also asserted that because lower life forms like bacteria and yeast fit within the definition of “invention,” higher life forms should not be excluded, as the Act does not make any distinctions based on the complexity of the subject matter.