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The Government Seeks Leave to Appeal the Federal Court of Appeal's Decision on the Harvard Oncomouse Case to the Supreme Court

OTTAWA, October 4, 2000 -- The Government of Canada served and filed an application on October 2 to seek leave to appeal the Federal Court of Appeal's decision on the Harvard oncomouse matter to the Supreme Court of Canada. The named applicant in the action is the Commissioner of Patents.

The Patent Office has consistently held the view that the current Patent Act does not allow for the patenting of higher life forms such as plants and animals. The Government of Canada supports this interpretation of the Patent Act. In its August 3rd, 2000 decision, the Federal Court of Appeal interpreted the definition of "invention" within the current Act as including genetically modified, non-human mammals, thereby setting an important legal precedent. Until this judgment, higher life forms were not patentable in Canada. The Federal Court of Appeal's decision could have far-reaching implications for Canada's patenting framework as it applies to biotechnology and potentially other fields of innovation. The government considers it necessary to refer the matter to the Supreme Court of Canada in order to obtain a definitive judgment on the scope of the current patent law. The government also intends to make a motion to stay the effect of the Court of Appeal's order, pending the application to the Supreme Court.

The government is also of the view that a public dialogue on the patenting of higher life forms is needed because this is an issue of significant public interest. In September 1999, the government established the Canadian Biotechnology Advisory Committee (CBAC) to provide it with policy advice on biotechnology-related matters. As part of its program Plan launched earlier this year, CBAC commenced an examination of the issues surrounding the patenting of higher life forms. CBAC will begin engaging the Canadian public, stakeholders and experts in a debate on the issue in the forthcoming months. The government will be attentive to this public dialogue and looks forward to receiving CBAC's advice.

Further information can be found at the Industry Canada web site at http://www.ic.gc.ca.

For further information, please contact:

Tony Macerollo
Office of the Minister of Industry
(613) 995-9001

Peter Davies
Canadian Intellectual Property Office
(819) 953-9067

The Government Seeks Leave to Appeal the Federal Court of Appeal's Decision on the Harvard Oncomouse Case to the Supreme Court

On August 3^rd, 2000, the Federal Court of Appeal issued a 2-1 split decision in the case entitled the President and Fellows of Harvard College v. Commissioner of Patents [Respondent] and Canadian Environmental Law Association [Intervenor]. The majority of the court ruled in favour of Harvard. Judge Rothstein and Judge Linden held that the Harvard oncomouse, a genetically-modified non-human mammal, was a "composition of matter" and thus, qualified as a patentable "invention" within the meaning of the current Patent Act. They also remitted the Harvard oncomouse patent application back to the Commissioner of Patents with an order to grant a patent on the Harvard oncomouse.

The Harvard oncomouse case stems from a patent application entitled "Transgenic Animals". Harvard first filed this application with the Canadian Intellectual Property Office on June 21^st, 1985. The subject matter claimed in this patent application included a genetically-modified mouse or a non-human mammal that was prone to developing cancer, an oncogene and the processes for isolating the oncogene and inserting it into the embryo of a mouse or a non-human mammal.

On March 23^rd, 1993, the patent examiners told Harvard that they would allow patents on its oncogene and on the related processes (i.e., claims 13-26 of the patent application), but not on the genetically-modified animal itself (i.e., claims 1-12 of the patent application). Harvard responded by requesting a review of the examiners' decision by the Commissioner of Patents.

In 1995, the Commissioner of Patents affirmed the examiners' decision and Harvard appealed to the Federal Court Trial Division. In 1998, Judge Nadon of the Federal Court Trial Division upheld the decisions of both the examiners and the Commissioner of Patents. In response, Harvard appealed to the Federal Court of Appeal.