The issue came before the Court in a case relating to the so-called "Harvard Mouse" which has featured in decisions on patentability in other jurisdictions and in respect of which a decision is still awaited in opposition proceedings in the European Patent Office. The claims related to a mammal, and in particular a mouse, that was genetically modified by inserting a gene (referred to as a transgene) into the oocyte from which it develops to make it particularly susceptible to cancer and, therefore, of use in testing of carcinogenicity of materials and for testing possible anti-cancer drugs. The basic question before the Court was whether such a mammal was a "manufacture" or "composition of matter", these being the only two items in the Canadian Patents Act's definition of a patentable invention that could be relevant. The judge noted the United States Supreme Court's decision in Diamond v. Chakrabarty which had by a 5-4 decision upheld the patentability of life forms, but said that he believed the reasoning of the minority more persuasive than that of the majority. He also noted the 1799 English decision in Hornblower v. Boulton that a manufacture was "something made by the hands of man." However, the judge went on to state:
a mouse is a complex life form and thus there are many features
of the mice that are not under the control of the inventors. .
. . [T]here is no way to separate the transgene from the rest
of the mouse once it is inserted and everything else about the
mouse is present completely independent of human intervention.
The creation of the oncomouse is a marriage between nature and
human intervention.
Therefore, the judge concluded that most features of the mouse were the product of nature rather than man and that since reproducibility is a requirement for patentability, and because:
the appellant has not made any claims to even minor control over
any aspect of the mammal except for the presence of the transgene,
the appellant can make no claim to be able to reproduce the mammal
at will by doing anything other than ordinary breeding.
The Supreme Court of Canada in Pioneer Hi-Bred v. Commissioner of Patents had already held that cross-breeding of soya beans fell outside the definition of what is patentable because of problems with reproducibility and that any change in this should be a matter for the legislature and not the courts.
In the present case, the judge held "the mouse is not truly reproducible as that term is understood in the Patents Act because too much is left to luck and chance as it was in Pioneer Hi-Bred".
March 1999 Index