Subject: Canada Rejects Patents on Higher Life Forms
From: MichaelP 
Date: 30 Jan 2003 17:10:56 -0600

http://www.i-sis.org.uk/crpohlf.php

Canada Rejects Patents on Higher Life Forms

Canada's Supreme Court rules out patents on higher life forms. Lim Li
Ching reports on this landmark decision and its wider implications.

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For complete decision of Canadian Supreme Court see

HARVARD COLLEGE V. CANADA (Commissioner of Patents)
http://www.lexum.umontreal.ca/csc-scc/en/rec/html/harvard.en.html
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Canada's ruling on 5 December 2002 makes her the only industrialized
country to prohibit patents on higher life forms. The test case was
Harvard University's 17-year quest for ownership of its genetically
engineered "oncomouse". Researchers inserted a cancer-promoting gene
(oncogene) into fertilised mouse eggs, producing transgenic mice more
susceptible to tumours, thus facilitating clinical work and faster
experimental results for cancer research.

The oncomouse was patented in the US in 1988, and has patent protection in
Australia, Japan and several European countries. The patents give Harvard
exclusive rights to create the mice and charge licensing fees for their
use. The "invention" is licensed to Du Pont, which sells the mice to
research labs.

In its application, Harvard sought to protect both the process by which
the oncomice are produced and the end product of the process, i.e. mouse
and offspring whose cells contain the oncogene. The process and product
claims extend to all similarly altered non-human mammals.

Canada allows single-celled organisms, such as yeasts and bacteria, and GM
crops to be patented. It also allows patents for modified human genes and
cell lines. The Supreme Court, Canada's highest court, however conceded
that ownership of more complicated life forms is a radically different
concept, thus ending the legal battles over the oncomouse.

Harvard had obtained a patent on the oncogene and related process claims
from the Canadian Intellectual Property Office in 1993 - but not on the
mouse itself or its offspring with the oncogene. The Commissioner of
Patents upheld the decision in 1995, and the Trial Division of the Federal
Court in 1998 dismissed Harvard's appeal against this.

In 2000 however, the Federal Court of Appeal overturned the trial judge
and concluded that both the process and the mouse could be patented.
Ruling 2-1 in favour of the full patent, it said that nothing in Canada's
1869 Patent Act outlawed patenting animals, although asserted that it
shouldn't be extended to allow patenting of human beings.

The Supreme Court ruling now puts the ball firmly in Parliament's court.
It ruled by 5-4 that a living mouse cannot be patented, even if its genes
are genetically modified. It said the mouse fails to meet the definition
of an invention.

The Canadian Patent Act defines "invention" as "any new and
useful art,
process, machine, manufacture or composition of matter, or any new and
useful improvement in any art, process, machine, manufacture or
composition of matter". The Supreme Court confined itself to debating
whether the words "manufacture" and "composition of
matter", within the
context of the Patent Act, are sufficiently broad to include higher life
forms.

The Court ruled that the mouse is not a "manufacture", as that denotes a
non-living, mechanistic product or process. And it isn't a "composition of
matter" either, because the phrase must be considered in the context of
the other words. Justice Michel Bastarache, writing for the majority,
said, "Just as 'machine' and 'manufacture' do not imply a living creature,
the words 'composition of matter' are best read as not including higher
life forms".

"Composition of matter", and hence patenting, can apply to lesser life
forms, the Supreme Court concluded, but not to higher life forms, as
animals' capacity to display emotion and to behave unpredictably separates
them from lower life forms and shows they are more than a composition of
matter. "Higher life forms are generally regarded as possessing qualities
and characteristics that transcend the particular genetic material of
which they are composed", wrote Justice Bastarache.

The judges conceded that the 133-year-old Patent Act is simply inadequate
to address the complex ethical and legal questions. Rather than extending
patent laws to higher life forms, as has been done by other nations'
courts, they urged that the issue be clearly addressed in Parliament. The
judges decided that the unique ethical issues posed by genetic engineering
of complex animals and plants are such that no higher life forms should be
patented in Canada until Parliament debates the issues and passes laws
specifically designed to address this rapidly developing realm of science.

One of the dissenting justices, Ian Binnie, dismissed the prospect that
allowing the patent on the Harvard mouse would open the door to patenting
humans, saying that the Canadian Charter of Rights would prohibit
ownership of human beings for commercial purposes. He claimed it ludicrous
that Canada should stand alone in refusing to grant patent protection to
Harvard.

But Justice Bastarache warned that the issue of human patenting is complex
and cannot be readily dismissed by reference to the Charter. He said that
it would be inappropriate for the courts to create an exception from
patentability for human life, given that this requires consideration of
what is human and which aspects of human life should be excluded.
Accordingly, he recommended that Parliament deal with the "increasingly
blurred line between human beings and other higher life forms".

The ruling was devastating for numerous Canadian companies awaiting
patents on plants and animals. They claim that it threatens to stifle
biotechnological research in Canada, by depriving researchers of legal
protection for their inventions. As many as 1,500 applications for plant
and animal patents have been on hold pending the Supreme Court's verdict.

Harvard denounced the decision, saying, "Canadian scientists are at risk
of being left behind their colleagues around the world". It urged
Parliament to change Canadian law to enable patenting of the mouse (and in
general non-human higher life forms, except where society makes such
research illegal).

Canada's national association of biotechnology research companies echoed
Harvard's warning. "This decision stops dead in its tracks our pursuit of
knowledge and innovation", said Janet Lambert, president of BIOTECanada.
The inability to receive life form patents "could create a chilling effect
on scientists doing research here".

But evidence shows that patents sometimes actually deter innovation.
Inventions that involve many patented components (as biotech usually does)
divert time and money from innovation into negotiating - and often
litigating - licences and royalties. Patent holders may use patents
strategically to prevent competitors from developing new products. Patents
also don't necessarily encourage public disclosure - one study showed that
20% of life-scientists delay disseminating research findings in order to
file patents. Ironically, leading US cancer researchers charge that the
meddlesome licensing policies of DuPont (which holds exclusive rights to
the oncomouse) are deterring scientists from researching with the
oncomouse.

Patents on life forms could foreclose opportunities for research and
product development to non-patent holders. While this potential is
inherent in patent systems, the impact may be more significant for
biotechnology products. Access to basics such as DNA sequences, cell
lines, plants and animals at reasonable cost, is crucial. High research
costs can drive up the price of the end product, many of which are
important for public health needs.

Those who would broaden what patents can cover say this is essential for
the viability of Canada's biotechnology industry. In fact, their case is
unclear; a 1995 survey indicated that Canada's weak intellectual property
regimes were not regarded by its biotechnology sector as important
obstacles. Mechanisms other than the patents can still encourage real
innovation.

The ramifications of this judgement on the patenting of GM crops and other
life forms remain to be seen. It is however expected to shape Canada's
policies on cloning and genetic engineering. a University of Saskatchewan
patent law specialist Martin Phillipson expects the ruling to derail as
yet unapproved patent applications, but that it won't roll back patents
already awarded for products such as Monsanto's Roundup Ready canola.
(Canadian farmer Percy Schmeiser has asked the Supreme Court to hear his
case, hoping it will overturn lower court rulings that found him guilty of
infringing Monsanto's patent, despite contamination of his crops by the
transgene.)

Phillipson argues that patents on life forms until now have covered events
within cells, while the resulting life form has not itself been patented.
Monsanto's and other crop patents apply to the process of splicing genes
and inserting them into cells, but have not been extended to living
plants, although the end result is still de facto protection of the whole
plant.

Industry Minister Allan Rock accepts the court's invitation to embark on
the thorny debate on how the government should address patenting higher
life forms, including humans. The government plans to consult its citizens
and the Canadian Biotechnology Advisory Committee (CBAC), an expert panel
that advises on biotech issues, before deciding what to do.

The CBAC recommended last June that Canada open its doors to animal and
plant patents. It has now renewed calls for Rock to revamp the Patent Act
so that it permits patents for all higher life forms except humans and
foetuses.

As the issue is hotly debated in Canada, implications on developing
countries should also be considered. The Canadian Catholic Organization
for Development and Peace asserts that banning life form patenting in
Canada will stop Canadian patents on seeds of staple food crops. Some 1.4
billion farmers depend on free access to seeds for their food security. It
said, "The Supreme Court decision should be a signal to the government
that Canada must use its influence within the World Trade Organization to
support developing countries in their efforts to resist pressure to allow
patents on seeds and other life forms".

The Africa Group in the WTO has already recognised the serious
implications patents on life forms would have on the rights of local
communities to food security. It proposed in 1999, and again in 2001, that
the mandated review of Article 27.3(b) of the Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS) (relating to patents on
living organisms and processes) should make clear that plants, animals and
micro-organisms and their parts, and all living processes, cannot be
patented.
 
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