Authors: A. David Morrow, and Colin B. Ingram, Ottawa
Originally published in February, 2003
In a 5:4 split decision released December 5, 2002, the Supreme Court of Canada overturned a Federal Court of Appeal ruling that patenting higher life forms is permissible under the Canadian Patent Act. David Morrow, Steven Garland and Colin Ingram of Smart & Biggar represented Harvard College in this landmark case.
With the Supreme Court’s decision it appears unlikely that any higher life form, plant or animal, is patentable under Canadian law. In this regard, Canadian law has now fallen out of step with a number of other jurisdictions, including the United States, Europe and Japan. For example, the Applicant, the President and Fellows of Harvard College, had already been issued a patent in the United States for their "oncomouse" in 1988, and a European patent in 1991.
As no further appeal is possible, the only remaining avenue for the patenting of higher life forms in Canada is for Parliament to amend the Patent Act to expressly provide for their patentability.
The reasons of the majority are based on the conclusion that higher life forms do not fit within the definitions of "manufacture" or "composition of matter." The majority commented that the phrase "composition of matter" "does not fit well with common understandings of human and animal life" and that "patenting higher life forms would involve a radical departure from the traditional patent regime."
Although the decision means that higher life forms are not patentable, the majority accepts that unicellular life forms and cell cultures are patentable, and expressly declines to attempt to locate the line between patentable lower life forms and unpatentable higher life forms.
The majority repeatedly observes that this topic should be left to Parliament, stating that "if higher life forms are to be patentable, it must be under the clear and unequivocal direction of Parliament." The majority reasons can be read as a clear invitation for Parliament to take up the subject.
In the immediate future, the Canadian patent profession will continue to explore effective ways of claiming genetically modified organisms short of claiming complete plants or animals. For example, the Patent Office accepts claims to modified genes, plasmids used to modify the genes, cells containing modified genes, methods of modifying genes, cells and life forms, methods of use of genes, cells and life forms, cultures of cells (including cultures of mammalian cells) and methods of use of cultures of cells. Claims to genes and cells may be effective to control the unauthorized reproduction of plants and animals.
Applicants with pending claims to genetically modified plants or animals who wish to attempt to retain those claims may elect to use various procedural techniques in order to keep the applications pending as long as possible, in the hope that amending legislation will intervene and render the claims patentable. Another possible technique is to make such claims the subject matter of a divisional application, while accepting a patent for allowable claims of the types discussed above. The divisional application would then be kept pending by various methods. Any such divisional application would be subject to possible concerns about double patenting which should be carefully evaluated before deciding on such a course of action.
Since the majority judgment specifically addressed only the patentability of mammals, and expressly refrained from defining the line between higher and lower life forms, it would be possible to pursue claims to, for example, a plant or an invertebrate, through the appeal process and possibly as far as the Supreme Court.
The content of this article does not constitute legal advice and should not be relied on in that way. Specific advice should be sought about your specific circumstances.