Intervenor: vol. 27, no. 3 - 4, July - December 2002

CELA in the Courts - Oncomouse Decision Applauded

CELA has been following and involved in the "Oncomouse" case since it went to the Federal Court Trial Division in the mid-1990s. At the Federal Court of Appeal, CELA was the only intervener granted standing to intervene in the case. CELA again obtained standing to intervene when the case went to the Supreme Court of Canada, with CELA counsel representing CELA and Greenpeace Canada, Canadian Association of Physicians for the Environment, Action Group on Erosion, Technology and Concentration and Canadian Institute for Environmental Law and Policy. CELA, through counsel Michelle Swenarchuk, Theresa McClenaghan and Paul Muldoon, made both written and oral submissions to the Federal Court of Appeal and to the Supreme Court of Canada.

The case concerned an application by the President and Fellows of Harvard College for a Canadian patent over a mouse (the "Oncomouse") which has been genetically altered for cancer research by way of an "oncogene" that makes it more susceptible to cancer. The Patent Examiner had already allowed the claims for the gene, and for the processes of inserting the gene into the mouse and for testing whether the gene was in the mouse, among other things. However, the Patent Examiner denied the claims for patents over the mammal and all other non-human mammals containing the oncogene, on the basis that the mammals were not included in the scope of the definition of "invention" under Canada's Patent Act.

The case went to the Commissioner of Patents and the Patent Appeal Board, and the Patent Examiner's decision was upheld. On appeal to the Federal Court Trial Division, the Patent Examiner's decision was again upheld. However, on further appeal to the Federal Court of Appeal, that court overturned the Patent Examiner's decision in a two to one decision.

The Supreme Court of Canada released its decision on December 5, 2002, in a five to four result, overturning the Federal Court of Appeal decision and reinstating the result in accordance with the Patent Examiner's decision. In the end result, the patents over the mammals as products of the process were denied. Higher life forms are not patentable in Canada under our Patent Act.

The Court's reasons (per Bastarache, J.) centred on the definition of the term "invention" under the Patent Act. Specifically, the Court found that mammals are not "manufactures" nor "compositions of matter" as required by the Act. The Court took pains to state that its decision was not based on its view of whether mammals ought to be patentable or not; but rather whether they fit within the definition of the existing Act.

The Court determined that "Parliament did not intend to include higher life forms within the definition of invention found in the Patent Act." The Court found support for that interpretation from "the fact that the patenting of higher life forms raises unique concerns which do not arise in respect of non-living inventions and which are not addressed by the scheme of the Act."

CELA in its arguments to the Court raised concerns regarding patenting of higher life forms related to patents stifling publication and dissemination of scientific research, licensing fees stifling research and innovation, inequitable distribution of the benefits derived from patenting life forms, especially with respect to southern countries from whose territories and peoples many life forms are appropriated, and environmental and biodiversity risks from the release of patented life forms into the environment. None of these issues can be dealt with under the current scheme of the Patent Act.

CELA argued that if life forms were to be patented in Canada, this could only be done by Parliament, which should follow a national debate concerning the patenting of higher life forms. The Court agreed, stating:
it is up to Parliament and not the courts to assess the validity of the distinction drawn by the Patent Office between higher life forms and lower life forms. … the patenting of all plants and animals, and not just human beings, raises several concerns that are not appropriately dealt with in the Patent Act.

Theresa McClenaghan is a lawyer at CELA