Patenting Transgenic Animals: The Oncomouse

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…"
Note that this claim took moral considerations into account to a certain extent by excluding humans. 

European Union: Patent granted. The European Patent Office developed a utilitarian balancing test that to determine whether it would be immoral to patent the oncomouse. The utilitarian balancing test weighs the negative moral effects that would result with respect to the medical benefits that using the oncomouse for research would provide. The EPO found that the medical benefits outweigh the negative moral effects, and therefore the oncomouse was granted patent rights. 

Canada: Patent rejected. Canadian patent examiners rejected patent claims on the oncomouse itself, but accepted claims on the process of creating the oncomouse. This case was appealed. In 2002, the Canadian Supreme Court ruled in a 5-4 decision against the oncomouse patents, arguing that the oncomouse is not patentable subject matter because 1) the body of a mouse is not a "composition of matter" created by humans and 2) the writers of the patent act did not have the body of animals in mind when considering patentable subject matter. 


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