Harvard Oncomouse Unpatentable: Supreme Court Delivers On Long-awaited Ruling On Patentability Of Higher Life Forms

Richard Naiberg (Partner) and Isabelle Roy (Articling Student)

In a 5:4 majority ruling delivered on December 5, 2002, the Supreme Court of Canada held that higher life forms are not patentable under Canada's Patent Act. This determination means that, while the process of manipulating genes to create a mouse carrying the cancer gene, as well as the fertilized oncomouse egg, remain patentable, the resulting mouse falls outside the protection of the Patent Act.

The sole issue before the Court was whether a higher life form comes within the statutory definition of a patentable invention under section 2 of the Patent Act as comprising of a "manufacture" or "composition of matter. No matter how ingenuous or useful an idea may be, Bastarache J. stated for the majority, the question was not what ought to be patented, but rather what could be patented according to the existing legislation. The majority held the view that the language of the Patent Act must be interpreted narrowly, all the while taking into consideration the context and the object of the entire Act. According to the majority, a mouse or any other higher life form - even if it has been genetically altered - is not an "invention" as defined under the Patent Act and, as such, falls outside the realm of what can be patented in Canada. Bastarache J. stated that the idea of a mouse being characterized as a mere composition of matter is not in keeping with common understanding of higher life. Harvard cannot be granted a patent on something which would have existed despite its genetic manipulation (i.e. the mouse).

Bastarache J. also placed much importance on the fact that the Patent Act is ill-equipped to deal with the patenting of higher life forms. In his view, Parliament never intended for higher life forms to be included in the definition of "invention". Patenting higher life forms is a contentious matter that raises a number of complex issues that require clear legislative action. Issues such as self-replication and the fact that higher life forms include humans are clearly beyond the scope of the Patent Act and, as such, demonstrate that the legislator never intended for higher life forms to be patentable.

In Bastarache J.'s view, the existence of subsequent legislation - like the Plant Breeders' Rights Act - supports the assertion that Parliament never intended for higher life forms, or even plants, to be patented. Plants were awarded protection under this act after the courts...