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4-Patents: Canadian court in favor for patent on onco-mouse



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TITLE:  The mouse that roared on animal pharm: Canadian court ruled
        that mammals can be a patented invention
SOURCE: Rural Advancement Foundation International, Canada
        www.rafi.org / rafi@rafi.org
DATE:   August 10, 2000

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


The mouse that roared on animal pharm: Canadian court ruled that 
mammals can be a patented invention

'There was considerable fanfare in this appeal that significant 
policy questions are at stake there were arguments made against 
patenting the oncomouse based on human health, environmental and 
other concerns. However, all that is at issue in this appeal is the 
interpretation of the Patent Act and the determination of whether, on 
the basis of the evidence, the appellant's product is patentable in 
accordance with that interpretation To the extent the appeal gives 
rise to policy questions, they are to be addressed by Parliament and 
not the Court.'

Judge Rothstein, for the majority Federal Court of Appeal, Canada, 
August 2000

'In all the circumstances of this case, including the limited role 
that our jurisprudence has assigned to the Courts in this area and 
the serious moral and ethical implications of this subject matter, it 
seems to me that Parliament is the most appropriate forum for the 
resolution of the issues in dispute here.' Judge Isaacs, Dissenting 
Opinion Federal Court of Appeal, Canada, August 2000

 In a split 2-1 decision, the Canadian Federal Court of Appeal ruled 
in favour of granting a patent to Harvard Medical School for the 
oncomouse, a mouse genetically engineered to carry a cancer-causing 
gene. The decision marks another point in the 15-year battle in the 
Canadian courts over whether Mother Nature or a Harvard scientist 
invented the mouse and its offspring. The decision overturned a 
Federal Court ruling and the decision of Canada s Patents 
Commissioner. The trial judge in the earlier decision had argued that 
although Harvard invented a process for inserting a gene into a 
mouse, 'they have not invented the mouse.'

The decision to grant a patent for this multicellular, higher life 
form opens the door to patenting any non-human life form. To date, 
Canada has granted patents for single-cell life forms, including 
human cell lines, but not for multi-cellular ones. Harvard modified 
the mouse by inserting a gene to cause it to develop cancer for use 
in research. However, the patent that was granted extends to all non-
human mammals, 'from a shrew to a whale' that might be similarly 
genetically engineered, even though Harvard has not performed these 
modifications.

'For the first time in Canada, something that can look you in the eye 
is considered an invention, ' noted Julie Delahanty of RAFI. 'The 
implications of this change in Canadian patent law are profound and 
the outcome will be viewed with dismay by many nations who have been 
following the Canadian case closely.' Developing countries are net 
importers of technologies and patented products, and for the most 
part are opposed to the patenting of life. Many of them have been 
following the case in Canada hoping it would strengthen their 
opposition to the life patenting provisions of the intellectual 
property (TRIPs) agreement of the World Trade Organization.

Quiet as a Mouse: The Canadian government has been noticeably silent 
on the political implications of the case. 'They have used the courts 
to sidestep their responsibility to consider the ethics and impact of 
the patenting of life forms,' says Delahanty. 'The court rulings on 
this case have twice agreed that the issue of life patenting is more 
rightly decided by Parliament, yet the government continues to avoid 
the democratic process and is instead hiding beneath the judge's 
robes.'

Through other official documents such as the Canadian Biotechnology 
Strategy, the present government has made it clear that they support 
the biotechnology industry s desire for patenting anything that 
moves. The decision in this case leaves them free to avoid broad 
public debate on the question of patenting life forms in Canada.

The Canadian Environmental Law Association (CELA) intervened in the 
case, arguing that the Federal Court decision should be upheld and 
that the patent should not be granted. Michelle Swenarchuk, Counsel 
and Director of International Programs for CELA argued that the Court 
is 'not the appropriate body to determine this question, since it was 
not in the position of having before it all the information required 
for a full examination of the implications of life form patenting. 
Rather, the decision should be made by legislative review, after a 
full public debate of all the implications. If Parliament did 
consider the issue,' adds Swenarchuck, 'it could then decide whether 
there should be safeguards such as ethcial and environmental reviews, 
other public protections for food security and the protection of 
animals, the appointment of a body of ethical advisors or involvement 
of the public in decisions made by the Patent Office. Only 
Parliament, not the Courts, can ensure that such s! ! afeguards are 
in place for the public interest.'

Mickey Mouse gets Real: Like the other copyrighted mouse, Mickey, the 
oncomouse, also serves corporate interests. Although the patent is 
owned by Harvard Medical School, an earlier commercialization 
arrangement leaves DuPont, a multinational Gene Giant, not Harvard, 
entitled to exclusive license of the patent. DuPont has claimed 
patent protection on any anticancer product ever derived from the 
mice.

The corporate excitement around the oncomouse reached its pinnacle in 
1988 when a major financial magazine labeled the mouse the product of 
the year. 'Animals can now have their genetic makeup altered to serve 
as a tool for corporate profit. They are no longer animals, but 
machines that are described as human inventions. This so-called 
invention is the ultimate 'better mouse trap,'' said Delahanty.

Allowing patents to be applied to engineered animals means that 
corporate interests can also impose the same kinds of conditions on 
livestock farming as they have on plant agriculture elsewhere. In 
fact, the issue is much clearer since farmers who breed livestock 
would have to pay a royalty for resulting offspring. 'Not only could 
this lead to further genetic erosion of domestic animals which are 
already being lost at a rate of 5% each year,' worries Delahanty, 
'but family livestock farms would resemble a modern version of feudal 
farms, with serfs paying the company royalties for their animal 
inventions.'

'This isn t about curing cancer, this is about making money,' said 
Paul Muldoon, Executive Director of CELA. 'I can see that many 
animals will be genetically altered, for whatever reason, and that 
industry will have control.'

Irresistible craving for cheese? There are currently approximately 
250 applications pending in the Canadian Intellectual Property Office 
dealing with animal patents that have been on hold awaiting this 
decision. When asked to divulge the nature of these patents, Murray 
Wilson, a spokesman for the Patent Commissioner, stated: 'Let your 
mind run wild what people could dream up for getting the body of an 
animal to do.' In Canada, one need not leave all to the imagination. 
For example, within the next year mice will be incubating the eggs of 
women who risk damaging their ovaries because of medical treatment. A 
team at the Mount Sinai Hospital in Toronto has already successfully 
harvested human eggs from the back muscles of rodents. (see Day, 
Michael, 'Mice to the rescue'. New Scientist, 1 July 2000, Page 7).

In the interests of science?: The Canadian lawyers representing 
Harvard argued that 'It is in the interest of the Canadian public to 
allow patents for higher life forms.' The Federal Court of Appeal 
majority decision agreed that without patent protection the 'creation 
of inventions' would be discouraged.

Despite these claims, the appeal court judges and the lawyers for 
Harvard have ignored not only the literature demonstrating that 
patents stifle rather than encourage research, but also the history 
of the oncomouse itself. At the outset, DuPont made the oncomouse 
available for basic research for a comparatively low fee and with no 
restrictions. In 1988, DuPont entered into an agreement with Charles 
River Laboratories to breed and distribute the oncomice that included 
provisions for downstream royalties (in other words, any product 
developed using the mouse in the research would be subject to royalty 
payment). As a result, the restrictions have become so limiting on 
downstream revenues that few scientists are purchasing or using the 
oncomice in their research.

The need to obtain patent licenses has imposed a significant burden 
on the research community that is neither necessary nor desirable for 
research. CELA argues for 'the free and unfettered exchange of the 
results of scientific research, a value now at risk due to increased 
commercialization of research, non-disclosure agreements, and the 
treatment of research results as proprietary.'

Of GM Mice or GM Men?: The court attempted to draw the line at people 
and warned that the decision does not endorse patents of human life. 
'The potential extension to human beings is an obvious concern,' 
stated Judge Rothstein for the majority. 'The answer is clearly that 
the Patent Act cannot be extended to cover human beings. Patenting is 
a form of ownership of property. Ownership concepts cannot be 
extended to human beings.' Despite such bland reassurances, critics 
are not so confident.

The Canadian and other patent offices already allow patents on human 
genes and cell lines. In 1997, a patent was granted by the World 
Intellectual Property Organization (WIPO) on a sheep named Dolly, the 
world s first cloned mammal. The patents held by the Roslin 
Institute, responsible for the Dolly experiment, cover the use of the 
technology in all animals, including humans. The Institute claimed 
that they included humans simply to ensure that nobody else could lay 
claim to human cloning. Such good intentions are dubious given the 
rate of corporate takeover of small operations and the knowledge that 
once the legal precedent has been set for the patenting of humans, 
turning the clocks back is almost impossible.

The line between what is human and what is not and therefore what 
multicellular human organisms can be patented is becoming fuzzier 
everyday. 'We re only a few genes ahead of being a salamander 
anyway,' says Pat Mooney, Executive Director of RAFI. 'Human genes 
and cells have already been patented. With the rapid advances in 
biotechnology and other technologies, it s hard to be overly 
confident that human beings will not eventually, also be the subject 
of a patent. Once you accept the patenting of life, there is 
virtually no way to keep the doors shut on the patenting of organs 
and any other parts of the human body that have a commercial 
application.'

 Judgement: Federal Court of Canada Docket A-334-98, President and 
Fellows of Harvard College and Commissioner of Patents et al.

For more information contact: Julie Delahanty -- RAFI, phone 819 827 
9949, email julie@rafi.org' Pat Mooney -- RAFI, phone 591 64 400 16, 
email rafi@rafi.org CELA, phone 416 960-2284








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