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Publications
Consultations
2000
CBAC Non-Governmental Organization Hearing on the Intellectual Property/Patenting of Higher Life Forms Project Steering Committee
Ottawa, Ontario
November 22, 2000
Rapporteur's Summary
By E. Richard Gold
Assistant Professor
Faculty of Law, University of Western Ontario
Senior Fellow
Einstein Institute for Science, Health & the Courts
Research Associate
Health Law Institute, University of Alberta
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The Non-Governmental Organization Hearing to the Intellectual
Property/Patenting of Higher Life Forms Committee (IP/PHL) of the
Canadian Biotechnology Advisory Committee (CBAC) brought together
representatives from various non-governmental organizations. These
non-governmental organizations ( NGOs ) included groups concerned
about the environment; about relations between developed and
developing nations; about patient issues; about animal welfare;
about consumers concerns; about agricultural communities; about
First Nations concerns; and about religious perspectives While
these organizations do not represent the entire breadth of views
that exist in the community on the issue of the patenting of higher
life forms, this group of organizations represents a cross-section
of views that will assist CBAC in formulating its ongoing
consultation strategy.
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As the Co-Chairs of the Hearing made clear, CBAC is interested in
examining ways in which to foster biotechnological innovation in a
way that is both consistent with Canadian values and contributes to
the Canadian economy. IP/PHL is at the beginning of a process of
public consultations with the aim of preparing a report on
intellectual property and the patenting of higher life forms for
the government of Canada. The Hearing was designed to start
discussions with various communities across Canada. IP/PHL
envisioned that these communities would be further consulted as the
consultation process developed.
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Many of the NGOs present at the Hearing stated that they had not
yet had the opportunity of formulating policy on the issue of the
patenting of higher life forms. Some organizations had attempted to
formulate policy, but had not yet been successful in doing so.
Other groups had not yet commenced discussions on this particular
issue. All groups welcomed the invitation to present their views to
IP/PHL, but many requested the opportunity to present their
policies once formulated.
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Because many NGOs had not developed policies on the broader issue
of intellectual property and the patenting of higher life forms,
many presented the set of values that motivated them in relation to
issues touching on biotechnology. This led necessarily to a general
discussion of ethical and social concerns rather than of concrete
suggestions in relation to the policies that Canada ought to
implement with respect to the patenting of higher life forms.
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Some organizations, such as the Rural Advancement Foundation
International (RAFI), the Canadian Environmental Law Association
(CELA), and the Assembly of First Nations (AFN) had, however,
developed policies with respect to biotechnology patenting. While
the Canadian Council of Churches did not have any formal policy on
the issue of patenting higher life forms, several affiliated
organizations had studied patent issues. All of these organizations
presented their policies at the Hearing.
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Richard Gold, who was invited to suggest a framework within which
ethical and social issues relating to higher life form patenting
could be understood, distinguished between two sorts of concerns:
those directly related to patenting itself and those for which the
patenting process provides a useful opportunity to evaluate
commercial and ethical conduct. The first set of concerns could be
further divided into three types: those related to initial research
leading to a patentable invention; those related to the patenting
of the invention itself; and those relating to commercial
development and distribution of the invention.
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Konrad Sechley, a practising patent agent, explained that the
patent system was designed to encourage commercial activity only
and was never intended to address other issues. Patents provide an
exclusive right to the patent holder in order to encourage
individuals to invent and bring their inventions as these are
defined by patent law to market. Patent law is, he explained, a
very technical area of law in which patent examiners evaluate
patent applications to ensure that they disclose a new, nonobvious,
and useful invention. By useful, the patent applicant must show
that the invention has a specific benefit and is not simply a
laboratory curiosity. Provided that higher life forms are
considered statutory subject matter and that they are new,
non-obvious and useful, they should be patentable in Canada.
However, at the present time, a higher life form is not considered
statutory subject matter by the Canadian Intellectual Property
Office.
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Both Drs Sechley and Gold questioned whether patent examiners in
patent offices had the experience and expertise to make ethical or
social judgements with respect to the patenting of higher life
forms. Richard Gold suggested that, to the extent that there was a
determination that ethical and social concerns ought to be taken
into account in the patent process, that this determination be left
to an administrative body with expertise in ethics and competition.
He further suggested that this body only be involved in an
opposition process rather than in the patent application review
process.
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The overall message that the NGOs communicated to IP/PHL was the
need to ensure that the values and social concerns that motivate
Canadians with respect to biotechnology take priority over
commercial concerns. This does not mean, however, that all the NGOs
saw any necessary conflict between the concerns of industry and
that of Canadians, although some certainly implied that this may be
the case. It does mean that, according to most NGOs, IP/PHL ought
to identify the values and social concerns at stake before
proposing policy on the issue of higher life forms.
General Concerns With Biotechnology
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As stated earlier, many of the concerns that the NGOs raised were
of a general nature and related more to biotechnology policy in
general than to the patenting of higher life forms in particular.
Nevertheless, the NGOs felt that these concerns provide a context
within which Canada ought to establish its policy over higher life
form patents.
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Because of the priority that the NGOs attach to the concerns of
Canadians over those of industry, several of the NGOs stated that
the question of higher life form patents ought to be resolved by
Parliament rather than by the courts. These organizations also
called for public participation in the legislative process. In this
regard, the NGOs viewed IP/PHL's preliminary consultations as a
good first step.
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Two groups, the Sierra Club of Canada (Sierra) and the Canadian
Council of Churches (CCC), suggested that these consultations
should address a question prior to that of the wisdom of patenting
higher life forms. They would have consultations on the issue of
whether Canada ought to embrace biotechnology at all.
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The various NGOs raised a series of concerns relating to
biotechnology research, the safety (to humans, to non-human
animals, and to the environment) of biotechnology, and to the
equitable distribution of the risks and benefits of the products of
biotechnology. While some groups were hopeful that biotechnology
would eventually result in products that would be beneficial to
humans, animals, and the environment, several groups were sceptical
that biotechnology would ever result in beneficial technologies.
Most NGOs were in agreement that, so far, biotechnology had not
resulted in a product that was helpful to the average person. In
fact, many of the NGOs present at the Hearing believed that present
genetically-modified products were harmful, overall, to health and
the environment.
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Many of the organizations present at the Hearing expressed deep
concern over the commodification of life. These organizations
believed that awarding patents over life forms would further
undermine humanity's respect for the natural world. One
participant pointed out, however, that humanity has treated
animals, in the agricultural context, as commodities.
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There was also considerable consensus among the organizations
present that the risks and benefits of biotechnology ought to be
equitably distributed. The Consumers Association of Canada (CAC)
stated, for example, that the risks and benefits of technology
ought to accrue to the same people. The AFN, RAFI, and the CCC were
concerned that the patent system provides no mechanism by which
communities with traditional knowledge would receive a benefit when
that knowledge is incorporated into a patented invention. Several
organizations stated that, in fact, indigenous peoples have the
right to benefit from their own resources and to have their
relationship with nature appropriately respected.
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Several NGOs argued that organized civil society has an important
role in acting as honest broker between government, industry,
researchers, and the public. NGOs are in a position, for example,
to challenge conflicts of interest and distributional inequalities
in terms of access and return from biotechnological innovation.
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A few of the organizations present at the Hearing challenged one of
the principal industry arguments made to CBAC in the Presidents/CEO
Briefing to IP/PHL held on September 29, 2000. During that
Briefing, the industry participants stated that Canada was viewed
internationally as being unwelcoming of biotechnology. As a result,
investors and head offices were reluctant to invest in
Canadian-based research and development. The NGOs argued that
Canada has, in fact, a reputation internationally as being one of
the strongest supporters of biotechnology and of industry. While it
may be true that the international business community does not
share this view, the vast majority of developing nations and
communities see Canada as strongly on the side of industry.
Issues Relating to Research
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Apart from the general concerns that the NGOs raised with respect
to biotechnology, several organizations discussed both problems and
benefits from higher life form patents.
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Several organizations stated that patents in the biotechnology
sector actually discourage innovation and increase the costs of
research and development. In their view, patents discourage the
sharing of germplasm from developing nations because these nations
fear that if they provide this material to industry, industry will
patent that germplasm and make it unavailable, in its newest form,
to these countries. Even within the developed world, patents may
discourage sharing of information among researchers.
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RAFI argued that patents also discourage innovation by placing
roadblocks in front of those conducting research. Researchers may
fear that their paths are so blocked by patents that it is not
worth conducting research.
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A couple of presenters believed that patents over higher life forms
augment the risk of conflicts of interest due to the increased
financial relationship between researchers and industry. While
researchers have always had to contend with conflicts arising from
competition for acknowledgement and advancement at research
organizations, patents have made this situation worse.
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One presenter, who is a researcher but also has an interest in a
biotechnology company, stated that patents encourage research,
leading to employment by small companies in Canada. This, and the
possibility of financial return from the commercialization of the
results of biotechnology research, add to the strength of the
Canadian economy.
Issues Relating to Patent Process
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RAFI stated that the patent system is currently overwhelmed by
biotechnology-related patent applications and is inefficient at
processing these applications. In addition, the costs, in both time
and money, of patent litigation has increased dramatically. This
makes enforcement of patent rights difficult. As a result,
according to RAFI, industry is looking at alternatives to patents
in order to protect their inventions. One of these alternatives is
the use of contractual provisions limiting the use that individuals
may make of technology coupled with increased monitoring of the use
of that technology. A second alternative is the development of
technological solutions to the use of technology. This includes the
socalled "Terminator" technology that renders seeds from
genetically-modified plants infertile should a farmer replant the
seeds. These alternatives permit industry to set the boundaries on
the use that individuals in society may to make of their
technologies without having to engage in the patent system.
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The CCC pointed out that the costs of patent litigation has a
second negative effect: the inability of traditional communities
and developing countries to challenge patents. The CCC pointed to
the patent that had been granted over the neem tree. While this
patent had been successfully challenged in an opposition proceeding
on the basis that the neem tree had traditionally been used in the
manner similar to that described in the patent, it had cost
millions of dollars and many years to attain this result. This high
cost of challenging patents makes it difficult for communities to
protect their traditional knowledge.
Issues Related to Commercialization
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There was general concern by those organizations present at the
Hearing that the products of biotechnological research be
accessible to all and that the benefits of the research be shared
with those from whom biological material was taken. Specifically,
the NGOs stated that medications produced by biotechnology ought to
be available at a reasonable cost, that no one ought to be denied
access to the use of the products of biotechnology, and that the
financial rewards of biotechnological innovation ought to be shared
with those who participated in the research by donating samples.
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The Canadian Federation of Agriculture suggested that, should
Canada permit the patenting of plants, that Canada enact a
farmers' privilege exception that would permit farmers to
re-use the seeds of plants they have grown. This exception has been
incorporated into European rules on biotechnology patenting.
Recommendations
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Several of the presenters at the Hearing recommended ways to
address the ethical and social issues involved with higher life
form patenting. These recommendations involved the establishment of
independent bodies to oversee parts of the research or
commercialization process, changes to patent law, and mechanisms to
ensure the fair distribution of the proceeds of biotechnological
innovation.
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One presenter suggested that Canada establish an ombudsperson. This
person would handle complaints by communities that feel that their
traditional knowledge or biological material has been taken without
their consent or without appropriate return to those communities.
Another suggestion was that Canada establish an independent
oversight committee to review the conduct of biotechnology research
and outcomes.
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RAFI suggested that Canada re-introduce compulsory licensing into
patent law. RAFI argued that industry ought to be content with a
guaranteed return from the investment. There was no need, according
to RAFI, for industry to be able to control access to such
important technology.
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The AFN suggested that Canada establish a trust into which a
determined royalty be paid for those using Canada's biological
resources. This fund would be used to compensate First Nations for
the use of the biological resources to which they are entitled.
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Those organizations that were most sceptical about the benefits of
biotechnology suggested that there be a moratorium on patenting
life forms until we have developed mechanisms to ensure not only
that biotechnology is safe but that the benefits of biotechnology
are equitably shared.
Conclusion
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The NGO Hearing brought together a representative group of
non-governmental organizations concerned about biotechnology. Many
organizations have not yet developed policies with respect to the
patenting of life forms. Nevertheless, they welcomed the
opportunity to present their concerns. They requested, however,
that IP/PHL provide them with further opportunities to present
their views once they have developed these policies.
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The NGOs expressed three general types of concern regarding the
patenting of higher life forms. First, they argued for policies
that would ensure that both the risks and benefits (including
financial rewards) of biotechnology be equitably shared among the
world's communities. Second, they stated that these
technologies ought to be broadly accessible. Third, they said that
oversight of biotechnological research and the distribution of the
products of that research was needed.
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