4-Patents: Transgenic animals now eligible for Canadian patent protection

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TITLE:  Transgenic animals now eligible for Canadian patent protection
SOURCE: IBS News Report, by Phillip B. C. Jones
        isb@nbiap.biochem.vt.edu
DATE:   October 3, 2000

------------------ archive: http://www.gene.ch/genet.html ------------------


Transgenic animals now eligible for Canadian patent protection

The Energizer(R) rabbit is not the only rodent that keeps on going. 
Harvard's 
oncomouse has been running the maze of Canada's patenting process for 
fifteen years. At this time, it looks as if persistence will pay off. 
Twelve years after the US patent issued on the oncomouse, the Canadian 
patent is poised for issuance.

The journey began in 1985 when the President and Fellows of Harvard College 
filed a patent application with the Canadian Intellectual Property Office 
(CIPO), which claimed nonhuman transgenic mammals with germ cells and 
somatic cells that contained an activated oncogene. By 1993, the CIPO 
examiner had decided to allow claims to the process for producing the 
transgenic mammals, but had finally rejected claims to the mammals 
themselves. The CIPO took the position that transgenic animals are not 
patentable under the Canadian Patent Act, which is silent about the 
patentability of animals per se. Moreover, the CIPO did not consider 
animals to fit into the patentable categories of "manufacture" or 
"composition of matter," as Harvard had been arguing. The CIPO found 
support for this limiting interpretation of patentability in the Federal 
Court of Appeal's decision, Pioneer Hi-Bred v. Canada (Commissioner of 
Patents).

On August 4, 1995, after review by the CIPO Commissioner of Patents and an 
oral hearing before the Patent Appeal Board, the CIPO confirmed the 
rejection of transgenic mammal claims. Harvard appealed the decision in the 
Federal Court Trial Division. Here, the judge decided that there was no 
dispute that the oncomouse met the patentability requirements of novelty, 
usefulness, and nonobviousness. Nevertheless, the question was whether the 
transgenic animal is an "invention" as defined by the Patent Act. 
Dismissing the appeal, the judge explained that the inventors of the 
oncomouse could not impose sufficient control over their creation. That is, 
once the oncogene was introduced, everything else about the oncomouse was 
independent of human intervention. Accordingly, the transgenic mammal was 
not sufficiently uniformly reproducible to be considered as a "composition 
of matter" or an "article of manufacture." This was in April of 1998. 
Harvard appealed the decision.

Last August, the Federal Court of Appeal, in a 2-1 decision, sent the 
matter back to the CIPO with the direction to grant a patent on the 
transgenic animal claims. Writing for the court, Justice J.A. Rothstein 
explained that the oncomouse is eligible for patent protection because the 
animal is, literally, a composition of matter. The judge decided that 
nothing in the term "composition of matter" suggests that living things, 
particularly higher (nonhuman) life forms, are excluded from the 
definition. In adopting an expansive meaning of "composition of matter," 
Justice Rothstein acknowledged the persuasiveness of the US Supreme Court 
decision, Diamond v. Chakrabarty.

The judge also distinguished the oncomouse invention from the Pioneer Hi-
Bred case, which concerned the crossbreeding of soybeans. Here, the 
significant difference is that the transgenic animal invention required 
"inventive ingenuity and intervention at the genetic level and the creation 
of a specific new life form."

With regard to the inventors' lack of control over all features of 
oncomice, the court found that control over characteristics such as eye 
color is irrelevant to the usefulness of the invention. In the end, Justice 
Rothstein explained that it is not up to the court to read limitations into 
the scope of patent legislation, and that Parliament could exclude higher 
life forms from patentability if it so desired.

Unless the Justice Department appeals the decision to the Supreme Court of 
Canada, the CIPO will need to deal with a backlog of about 250 patent 
applications on transgenic animals.

Sources
1. President and Fellows of Harvard College v. Commissioner of Patents, 
Docket No. A-334-98, August 3, 2000. Available from the Office of the 
Commissioner for Federal Judicial Affairs: http://www.fja.gc.ca/en/cf/2000/
orig/html/2000fca27094.o.en.html
2. Janice Tibbetts. 2000. No law planned to ban patenting of animals: 
Harvard mouse ruling won't spur changes to Patent Act: Agency boss. The 
Ottawa Citizen, August 8, A4.

Phillip B. C. Jones, Ph.D., J.D. Seattle, Washington 
mailto:pbcj@wolfenet.com 

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