In the 1980s Harvard scientists introduced an oncogene, a gene that triggers tumor growth, to a mouse. This led to the production of the transgenic oncomouse: a genetically modified mouse especially susceptible to cancer. The oncomouse is a valuable model for cancer research.
Given the scientific ingenuity put into innovating the oncomouse and its resulting value, Harvard applied for a patent on the oncomouse in the US, European Union, and Canada. This application raised a couple of questions key to biotechnology patents, each answered differently by different jurisdictions:
- If animals reach patentability requirements of novelty, non-obviousness, and utility, are they patentable subject matter?
- Is there a difference in patentability for higher level animals versus lower? If so, where is the line between higher level animals and lower level?
- How should moral considerations be applied to the patentability of transgenic animals? Should potential suffering of transgenic animals be taken into account when considering animal patents?
United States: Patent granted. In 1988, USPTO granted Harvard patent rights on the oncomouse claiming:
"a transgenic non-human mammal whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal…"