[Toronto Globe and Mail]
POSTED AT 12:37 PM EDT    Thursday, December 5
Harvard Mouse can't be patented
By KIRK MAKIN and DARREN YOURK
Globe and Mail Update


Higher life-forms cannot be patented in Canada until Parliament
specifically debates the ramifications and states that they can, the
Supreme Court of Canada ruled Thursday.

The decisive, 5-4 ruling ended a 17-year battle waged by Harvard
University to patent a genetically engineered mouse - the oncomouse - that
develops cancer at a sharply increased rate.

The court majority said the ethical issues involved in allowing patents
for higher-life forms involves drawing lines between species - an act that
ought to be done by parliamentarians.

It said that simply because lower life forms are patentable in Canada, it
does not logically follow that higher life forms meet the criteria for
patentable material.

"I am of the opinion that the unique concerns and issues raised by the
patentability of plants and animals necessitate a parliamentary response,"
Mr. Justice Michel Bastarache said for the majority.

The ruling was a major victory for a broad coalition of religious groups
and environmentalists who feared the practical and ethical ramifications
of letting scientists to claim ownership over genetically-manipulated
life-forms.

They portrayed a future in which lower life-forms in which "species
integrity" is endlessly distorted by researchers.

"It is a huge legal and ethical victory," said Jerry DeMarco, counsel for
the Sierra Legal Defence Fund. "We saved the mouse from the legal trap
just as it was about to close."

Mr. DeMarco said that proponents of patenting higher life forms will have
to justify their viewpoint in a much broader context than a specific case
that involved a specific transgenic mouse.

He also praised the court for "going against the tide" of other countries,
where research and the commercial interests in patenting were placed ahead
of ethical and philosophical issues.

"We knew it was going to be tight based on the different lines of
questioning by the judges when the appeal was heard," Mr. DeMarco said.
"The really big deal is the ethical side. Patenting life - especially when
it involved altering just a few small aspects of the mouse - wasn't
right."

In tossing the issue into the lap of Parliament, the dissenting judges
stated that: "neither the Commission of Patents nor the courts have the
authority to declare, in effect, a moratorium on life (or "higher" life)
patents until Parliament chooses to act."

The dissenting judges also argued that the mouse was patentable under
Section 2 of the Patent Act.

"The extraordinary scientific achievement of altering every single cell in
the body of an animal which does not in this altered form exist in nature,
by human modification of the genetic material of which it is composed, is
an inventive 'composition of matter' within the meaning of s. 2 of the
Patent Act," their dissent read.

The case highlighted how ill-equipped a 100-year-old piece of legislation
was to deal with a profusion of highly sophisticated modern issues.

Indeed, there was a note of frustration in 1993, when the Canadian
Intellectual Property Office agreed to register a patent on the Harvard
Mouse's cancer-prone gene as well as related experiments - but not on the
mouse itself or its offspring containing the "oncogene."

The Federal Court of Canada upheld their rulings, but the Federal Court of
Appeal ruled 2-1 to overturn it. The majority of that court found nothing
in the Patents Act to prohibit the patenting of animals.

Hundreds of patent requests have been pending in Canada while the case
worked its way through the courts. Last year, the Canadian Biotechnology
Advisory Council, which advises the government on issues involving
genetic-modification, threw its weight behind the patenting of some plant
and animal life forms - but not humans.

"This is a victory for life," Joanne Dufay of Greenpeace Canada said
Thursday. "The court got it right in terms of the law and in terms of
public perception."

Rick Smith of the International Fund for Animal Welfare said with the
decision the Supreme Court of Canada shut the door on a "privatized
parallel animal kingdom."

"The court certainly got this right," Mr. Smith told reporters. "Canadians
certainly distinguished between things that are easily patentable, like
Velcro, zippers and car engines, and higher lifeforms, like mice or
gorillas or whales."

BIOTECanada, the national association of biotechnology researchers and
practitioners, called the decision "bad news" for consumers and the
Canadian biotechnology community.

"Patents are not about owning a product or technology. Instead, patents
allow for a framework under which someone with a novel product or
technology can pursue scientific invention within the public domain, while
being protected from the threat of someone else stealing their research,"
Janet Lambert, President of BIOTECanada said in a statement.

"This decision stops our pursuit of knowledge and innovation dead in our
tracks. It is a great loss to Canada at both the social and economic
level."

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