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2001
Patenting of Higher Life Forms and Human Biological Materials: An Introduction to the Issues
Prepared for
Project Steering Committee on Intellectual Property and the Patenting
of Higher Life Forms, Canadian Biotechnology Advisory Committee
By Ted Schrecker * and Alex
Wellington **
January, 2000; revised February, 2001
Table of Contents
-
Introduction
-
Understanding Intellectual Property and
Biotechnology
-
Patents and Intellectual Property: Nuts
and Bolts
-
Patents and Intellectual Property:
Philosophy
-
Patents and Living Matter
-
The European Legal Approach
-
Canada’s International
Commitments
-
Ethical Questions About Patenting Higher Life
Forms and Human Biological Materials
-
First Steps
-
The Conceptual Framework: Forms of
Argument
-
The International Dimension
-
Policy Options and Responses
-
The Status Quo
-
Subject Matter Exclusions
-
Opposition Procedures
-
Infringement Exemptions and
Compulsory Licensing
-
Upstream Conditions
-
Regulation, Old and New
-
Conclusion
-
Resources: For Further Information
Authors’ Preface
In January, 2000 this paper was revised in response to three external
reviews as well as comments from several government sources. In
January and February, 2001 it was revised to take into account
developments during the year 20 00 in the litigation involving the
Harvard mouse patent, to update a number of other points, and to
reflect the comments of an additional reviewer.
Both academic reviewers of the previous draft expressed concern about
the brevity of the paper, given the range of issues to be covered; a
communications strategist, con versely, worried about the difficulty
of some of the material. We are sympathetic to both perspectives, but
view this paper as a manageable introduction to a complicated field of
law, public policy and ethics that has until recently been the domain
of specialists. It is a starting point, a point of entry into the
debate, and only that. Readers interested in more information –
and we hope there are many such readers – are encouraged to
start by consulting the list of resources at the end of the paper.
Ted Schrecker
Alex Wellington
February, 2001
-
Introduction
The twenty-first century may well be the century of biologically
based industry, just as the last decades of the twentieth
century were driven, in a technological sense, by the integrated
circuit. Canadians have a particular stake in the development of
knowledge based industries like those arising from biological
research, because of our historically high (and precarious)
reliance on commodity exports.
Intellectual property (IP) protection is currently a focus of
legal reform around the world, indicative of the crucial role of
knowledge based industry in modern economies. Many
industrialized countries are pinning their hopes of
competitiveness in the new international political economy on an
expansion of intellectual property rights. Contemporary business
interests have set out to expand the purview of patents, in
particular, into areas of recent technological innovation and
application, such as biotechnology. These efforts have not gone
uncontested. Social activists and academics have been strongly
critical of many aspects of the expansion of IP rights. One of
the most prominent sites of contestation presently is the issue
of patenting transgenic animals (see Box 1). In addition, some
scholars question the evidence linking patent protection either
with economic gains, or with the widespread diffusion of
socially beneficial research findings.
Canada needs to develop a comprehensive policy position on the
patenting of higher life forms and human biological materials.1 Because we do not now have
such a policy, an important dispute about the scope of patent
protection for one particular transgenic animal, the so-called
Harvard mouse, has been left to the courts to re solve without
any guidance beyond that provided by current legislation. Future
patent applications could involve not only transgenic animals,
but also such innovations as human tissues or organs grown in
the laboratory from human embryo stem cells (Box 3). Thus,
aproactive approach to the social and ethical issues involved in
patenting the results of advanced biological research is needed.
An element of urgency is present, as well, because IP issues are
part of the ongoing agenda in negotiations to create a Free
Trade Area of the Americas (FTAA). These negotiations began in
1994 and are scheduled for completion by the year 2005; as of
January, 2001, Canada had made no submissions to the FTAA
Negotiating Group on Intellectual Property Rights. IP issues are
also likely to be central to any future multilateral trade
negotiations under the auspices of the World Trade Organization
(WTO), as national governments seek to improve their competitive
position in the global economy.
This discussion paper was prepared as one step in a long history
of federal government initiatives to explore the social and
ethical implications of biotechnology. These initiatives began
with research commissioned in 1993/94, and included a series of
national consultations on renewal of the Canadian Biotechnology
Strategy. One result of those consultations was the
establishment of the Canadian Biotechnology Advisory Committee
(CBAC), which advises the Biotechnology Ministerial Coordinating
Committee – consisting of the Ministers of Industry,
Agriculture and Agri-Food Canada, Health, Environment, Natural
Resources, Fisheries and Oceans and Foreign Affairs and Inte
rnational Trade – on the full range of policy issues
related to the development and application of biotechnology in
Canada.
Note 1: Transgenic animals: Transgenic
animals are those whose normal genetic makeup has been
changed by the incorporation of one or more genes from
another species.
The genetic makeup of the Harvard mouse, perhaps the best
known such animal, has been modified by the incorporation
into a mouse embryo of a gene that confers high
susceptibility to tumours (an ‘oncogene
sequence’). The mice that carry the gene, which is
transmitted to future generations in accordance with the
principles of Mendelian inheritance, are valuable in
laboratory studies of cancer. Genetically modified animals
are also under development as sources of human proteins in
relatively large quantities, and of organs for
transplantation into human beings
(‘xenotransplantation’).
Patent protection for transgenic animals attracts criticism
both from those who think that it is inherently wrong to
claim intellectual property rights over the genetic blueprint
of animals, and from those who worry that such a practice
would lead to such undesirable outcomes as a decline in
respect for the sanctity of life. Apprehensions of this
second kind are invoked as an objection to many areas of
biotechnology research and development. Thus, the criticism
involves more than just patenting transgenic animals.
-
Understanding Intellectual Property
and Biotechnology
-
Patents and Intellectual
Property: Nuts and Bolts
In simplified terms, an inventor who applies for a patent
is applying for the grant of a limited monopoly. If a
patent is awarded, the patent holder may be either the
inventor or an ‘assignee’ such as a university
or a for-profit corporation to which the inventor has
agreed to turn over rights to the patent. The patent
holder is entitled to exclude others from making, selling
or using the invention covered by the patent for a
specified period of time (currently 20 years) from the
date of filing. In return for that limited term monopoly,
a patent application must provide sufficient detail to
enable the ordinarily skilled worker in the field to
reproduce the invention, which can legally be done either
through licensing arrangements or once the patent has
expired. In Canada, the contents of a patent application
must be disclosed no later than 18 months after the
application is filed, whether or not a patent is awarded.
Canada’s Patent Act defines an 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 applicant
for a patent must demonstrate:
-
novelty: the invention must be new, and with some
exceptions must not have been disclosed publicly before
a patent application was filed;
-
utility or usefulness: the invention must have some
potential industrial or commercial application; and
-
non-obviousness: the invention must not be obvious to
someone with the relevant specialized skills.
In these respects, Canadian patent law is substantially
similar to the regimes that are in place elsewhere in the
industrialized world.
Note 2: Expressed sequence tags (ESTs)
are short sequences of DNA used by scientists to
identify much longer sequences of which they are a
part, even though what the sequence does in the human
body may not yet be known.
In November 1998, the U.S. Patent and Trademark Office
issued the first U.S. patent for an EST, thus
intensifying concerns that were already widespread
within the scientific com munity about whether
researchers would have to negotiate licences for each
EST they wish to use for purposes of their own work: a
time-consuming and costly process.
It was once thought that patent applicants’
inability to demonstrate the utility of ESTs would
prevent the granting of patents. However, the potential
for use as a research tool may now be sufficient to
demonstrate utility, and at least in the United States
attention is shifting instead to the appropriate scope
of patent claims involving ESTs: will a subsequent
patent claim to a much longer, functional DNA sequence
that includes a patented EST be disallowed?
An important distinction exists in patent law between
discoveries, which are not patentable, and inventions. A
DNA sequence in a purified and reproducible form, which
makes it commercially useful, is considered patentable,
although some critics argue that this shou ld not be the
case because the inventive step is not substantial enough
to justify granting IP protection to the products that
result. A similarly contentious issue, having to do with
utility rather than with the distinction between
discoveries and inventions, involves the granting of
patents on expressed sequence tags, or ESTs (Box 2). In
January 2001, the US Patent and Trademark Office issued
new guidelines to the effect that: “You can patent a
gene but only if it meets a three-prong test of utility
– that is, having specific, credible and substantial
uses,” in the words of a US official.
Patents cannot be granted for “any mere scientific
principle or abstract theorem.” Also not patentable
are: medical or surgical treatments; schemes or plans, or
methods for doing business. Previously, Canada's
Patent Act contained an exclusion from
patentability applicable to “an invention that has
an illicit object in view.” This exclusion was not
meant to be a ‘morality clause,’ and the
passage was removed from the Patent Act as part of a
package of legislation aimed at bringing various Canadian
statutes into compliance with the provisions of the North
American Free Trade Agreement (NAFTA). The Patent
Act also provides that the Canadian Nuclear Safety
Commission (CNSC) must receive notice of any patent
application related to nuclear energy, although the
section does not appear to give CNSC a role in rejecting
patents on grounds not elsewhere specified in the Act.
A patent application consists of several parts: the
disclosu re and the claims. In the disclosure section, the
applicant describes the invention, and provides background
information, often including drawings. Disclosure must
show how to make and use products, or must set out the
various steps and sequence of any process. The claims, on
the other hand, mark out the boundaries of the innovative
territory over which the applicant wishes to stake a
claim. Each claim is independently evaluated, and any one
claim in a patent application may be rejected or modified
without affecting the validity of the others.
The government agency responsible for granting patents in
Canada is the Canadian Intellectual Property Office, or
CIPO, which is part of Industry Canada. In legal terms,
patents are granted not by CIPO but rather by the
Commissioner of Patents, a senior public servant who also
serves as the chief executive officer of CIPO. Decisions
on patent applications are made by patent examiners, who
may engage in extensive consultation and discussion with
the applicant’s patent agent; the discussion may
lead to redrafting and resubmission of some or all of the
patent claims. If all or part of a patent application is
rejected, the applicant may request review by the Patent
Appeal Board, an internal tribunal of CIPO that advises
the Commissioner of Patents. After such a review, either
party may appeal the decision of the Commissioner to the
Federal Court of Canada, and ultimately to the Supreme
Court of Canada.
Patents may be granted for products and for processes. In
the case of the Harvard mouse, the application for a
patent on the “transgenic non-human mammal”
was denied by a patent examiner, the Patent Appeal Board
and the Commissioner of Patents, although the process
claims were accepted. The applicants appealed the matter
to the courts, and the results are discussed in section
II.3 of this paper. The United States granted a patent for
the animal itself in 1988, the first such patent ever
awarded.
-
Patents and Intellectual
Property: Philosophy
The patent system in industrialized countries has
historically been designed around what political scientist
G. Bruce Doern has called a “trade-off between
protecting creations and inventions of the mind and
disseminating such creations for the broader good of
society.” 2 Two
distinct philosophical justifications exist for the system
of law that implements the trade-off.
The first involves a line of reasoning that can be traced
back at least to the seventeenth century English
philosopher John Locke, for whom “justice [gave] e
very man a title to the product of his honest
industry”; 3
depriving inventors of that return would be unfair. The
motivation for intellectual property protection, on this
account, is to give inventors what is their due.
The second relies instead on the argument that without
intellectual property rights to prote ct “creations
and inventions of the mind” from being appropriated
by others, inventors and investors would be less likely to
bring those creations forward from the basement workshop
or the lab bench to the m arketplace. The prospect of a
patent offers at least the chance of a return on their
commitments of time, effort and money. Otherwise, it would
be too easy for imitators to reap the rewards with little
actual outlay of their own. The result, so the argument
goes, would be a climate in which socially desirable
innovation of various kinds would be inhibited.
Informed policy choices must therefore be guided by
accurate information about how patent protection actually
affects research and innovation. Graham Strachan, the
president of Canada’s Allelix Biopharmaceuticals,
notes that “intellectual property status is one of
the first questions asked of the biopharmaceutical CEO
when out trying to raise money from the financial
gatekeepers.” 4
On the other hand, the multiplication of patents and
patent applications may actually slow down biological
research, if scientists find it necessary to enter into
costly licensing arrangements in order to avoid possible
subsequent liability for patent infringement.
In a play on words, it has been suggested that expansive
patent protection may result in a “tragedy of the
anticommons” in biomedical research: the direct
opposite of Garrett Hardin’s tragedy of the commons,
in which inadequate specification of property rights leads
to destru ctive results. 5 The concern is that ov
er-protecting intellectual property co uld actually
inhibit innovation over the longer term. A related
concern, which involves more general issues of the
appropriate relations between commercial concerns and the
scientific enterprise, arises when scientists delay
publication of research findings that may have commercial
po tential until a patent application has been filed.
-
Patents and Living Matter
Most practitioners and scholars in IP law hold that the
granting of a patent implies no conclusion about the
desirability of a particular invention, or of its
commercialization. A patent does not carry with it
official approval to market a particular invention or the
products of a patented process. Depending on the nature of
the product or process, that approval may require a number
of other governmental decisions. For instance, in Canada
novel varieties of crop plants, whether produced by
genetic modification or by conventional plant breeding
methods, must receive approval from Agriculture Canada.
Veterinary biopharmaceuticals and prescription drugs must
be approved by Health Canada before being marketed.
Neither does a patent ensure commercial success; that is
ultimately up to the market.
Against this claim, it can be argued that patenting of
higher life forms or human biological materials implies
willingness to live with a variety of possible
consequences that would occur if a patented invention met
with widespread commercial acceptance, even though such
consequences may be ethically disturbing. It can also be
argued that patenting implies rejecting apprehensions
about the intrinsic wrongness of establishing intellectual
property rights to the genetic blueprint of living
organisms.
Canadian patent law makes no explicit reference to ethics.
Although the Patent Act says nothing about living
matter, a patent for a human cell line was issued in
Canada as early as 1976, and microorganisms have been
considered patentable subject matter since 1982 by virtue
of a decision of the Patent Appeal Board. 6 Patents on human DNA
sequences (‘human genes’) have been issued in
most of the industrialized world, including Canada. Bartha
Maria Knoppers, a legal scholar who is both a member of
CBAC and chair of the Ethics Committee of the
international Human Genome Organization, has no ted that
it would take “a total revolution of traditional pa
tenting criteria” to restrict the patenting of human
genetic material beyond prohibiting the granting of
patents on a DNA sequence “in the natural
state.” 7
Courts in Canada and the United States have taken similar
approaches to interpreting the two countries’ patent
legislation. In Diamond v. Chakra barty, a case
that involved a patent on a genetically engineered
bacterium capable of degrading crude oil, the US Supreme
Court ruled in 1980 that a living organism could indeed
constitute patentable subject matter. The majority of the
justices held that if Congress had meant to restrict the
scope of patent protection, it would have said so in
legislation. In August 2000, Canada’s Federal Court
of Appeal, placing considerable reliance on the
Chakrabarty decision, held that the Patent
Act does not preclude treating a living mammal as
patentable subject matter, and that: “The provisions
of the Patent Act have been cast in broad terms
to fulfil Parliament"s objective -- to promote
invention. If anyone is of the opinion that the scope of
patentability should be narrowed, it is open to that
person to ask Parliament to do so.” 8 The Supreme Court of Canada
has now been asked for leave to appeal this decision.
Interestingly, in both the Canadian and US court
decisions, dissenting justices argued that the patent in
question should not be granted. In September, 2000, CBAC
encouraged “the Government of Canada to take all
reasonable and feasible steps to facilitate Parliamentary
review of the issue of patenting of biological products
and processes.”
A 1998 poll commissioned by the Canadian Biotechnology
Strategy Task Force found that 94 percent of respondents
thought ethical considerations should be taken into
account when determining whether or not to grant a patent.
An earlier (1994) poll found that Canadians’ views
about the acceptability of patents on “life forms
created through biotechnology” varied with the
intended uses of the plants, animals or human genes that
were covered by patents. Only 24 percent of those surveyed
agreed that “patents on any form of life developed
through biotechnology are acceptable,” and 51
percent regarded patents on altered human genes as
unacceptable “if it would lead to commercialization
of the human body.” 9 It must be noted that, for
some critics, that commercialization has already begun to
occur with the proliferation of patents on human DNA
sequences.
-
The European Legal Approach
In the countries that comprise the European Union, two
distinct legal frameworks identify ethical considerations
that might justify the refusal of a patent. The first of
these is the European Patent Convention (EPC), to which
all EU countries are signatories; the EPC is administered
and implemented by the European Patent Office (EPO). 10 The EPC prohibits the
granting of patents on
... inventions the publication or exploitation of which
would be contrary to ‘ordre
public’ or morality, provided that the
exploitation shall not be deemed to be so contrary merely
because it is prohibited by law or regulation in some or
all of the Contracting States. “Ordre public,” translated
literally, means simply public order. However, in
international law the concept has a somewhat broader
meaning, which includes elements of public policy not
related to order in the English sense of the word.
The EPC also allows for third party opposition, a
procedure in which “any person” has nine
months following the grant of a patent to file an
objection. This procedure has been used on numerous
occasions by ‘public interest’ intervenors
like Greenpeace, as well as by those motivated by
commercial concerns. No comparable procedure exists in
Canada or the United States.
The implementing regulations of the EPC have now been
modified in order to bring them into line with the second
framework: EU Directive 98/44 on the legal protection of
biotechnological inventions. Directive 98/44, which was
aimed at harmonizing patent protection for biotechnology
across the EU’s member countries, not only
incorporates the provisions of the EPC related to
“ordre public or
morality,” but also specifically rules out patents
on:
-
the human body, at the various stages of its formation
and development;
-
processes for cloning human beings;
-
processes for modifying the germ line genetic identity
of human beings;
-
uses of human embryos for industrial or commercial
purposes; and
-
processes for modifying the genetic identity of animals
which are likely to cause them suffering without any
substantial medical benefit to man or animal, and also
animals resulting from such processes.
The provisions of the EPC relating to “ordre public or morality” have
been used unsuccessfully under the opposition procedure to
challenge several key biotechnology patents, including the
patent on the Harvard mouse. However, in December 1999 the
EPO awarded a patent to Edinburgh University and an
Australian biotech firm for a way of genetically altering
the cells of mammals, which could then be used to create
embryos. As awarded, the patent would have included
processes for ‘cloning’ human beings. Numerous
oppositions were quickly filed, and the patent applicants
responded by revising their claims to exclude application
to human beings. As a result of the controversy, the
Administrative Council of the EPO noted in June, 2000:
Internal measures have been taken to prevent similar
situations occurring in future. The ‘early warning
system’ for applications filed in this sensitive
area of technology has been improved. All [patent]
examiners in this field have been reminded of the heavy
responsibility they bear, especially when examining
whether an invention should be excluded from patentability
on the grounds that it is contrary to ‘ordre public’ or morality
within the mea ning of Article 53(a) EPC or because it
does not meet those requirements set out in the
Implementing Regulations which were incorporated into
European patent law from the Biotechnology Directive.11
Thus, despite the lack of success associated with formal
oppositions to European patents based on the “ordre public or morality”
exclusion, the exclusion apparently is far from being a
dead issue in terms of affecting EPO decision making.
Apart from such cases, the wording of Directive 98/44
illustrates the problems of interpretation that must be
confronted in efforts to draft descriptions of
unpatentable subject matter, in any jurisdiction. For
example, will human organs grown in vitro from
human embryo stem cells (Box 3) be considered patentable
subject matter, or would they instead be viewed as
constituting a commercial use of the human embryo? What
about steps involved in producing such organs from human
embryo stem cells?
-
Canada’s International
Commitments
In making policy related to patents on higher life forms
and human biological materials, Canada is constrained by a
variety of international obligations. Perhaps the most
important are NAFTA and the agreement on Trade-Related
Aspects of Intellectual Property (TRIPs); TRIPs is part of
the WTO Agreement reached in 1994. These agreements for
the first time incorporated the idea that IP issues affect
economic competitiveness in the same way as the tariffs
and subsidies that were the more familiar concerns of
trade policy and law.
Note 3: Embryonic Stem Cells (ES cells),
which are present only in the very early stages of
embryonic development, have the special ability to develop
into almost any type of tissue or organ. That is, they are
‘pluripotent’. In November 1998, a US
scientist showed that ES cells, in this case taken from an
embryo donated by a couple who had received treatment for
infertility, could be cultured in the laboratory –
opening up a range of possibilities for research on human
biological development. It is possible that stem cells
could ev entually be used to generate a variety of human
tissues and organs in the laboratory, for purposes of
treating injury or disease. Controversies surrounding stem
cell research have so far focussed on the source of the
cells, which can be obtained from embryos ‘left
over’ from in vitro fertilization of human
ova. Somatic cell nuclear transfer – the process
used to ‘clone’ the famous sheep Dolly –
could also be used to generate such cells. Both the United
States and the United Kingdom have recently relaxed their
national governments’ controls on stem cell
research, citing the potential therapeutic benefits of
such research. Given the immense clinical and research
possibilities, it seems likely that patent protection will
be sought for many scientific advances, as is the case in
the area of xenotransplantation.
The two agreements contain virtually identical provisions
on what kinds of subject matter governments may exclude
from patentability (subject matter exclusions), quoted
below from Article 27 of TRIPs. The parallel provisions
are found in Article 1709 of NAFTA.
1. Subject to paragraphs 2 and 3, patents shall be
available for any new inventions, whether products or
processes, in all fields of technology, provided that they
are new, involve an inventive step and are capable of
industrial application. .... [P]atents shall be available
and patent rights enjoyable without discrimination as to
the place of invention, the field of technology and
whether products are imported or locally produced.
The dispute resolution mechanisms established under the
WTO Agreement and under NAFTA have not yet addressed the
interpretation of this provision as it relates to
biotechnology. However, problems would almost certainly
arise if Canada were to impose special requirements on
applications for patents on higher life forms and human
biological materials, unless those requirem ents could be
defended with reference to one of the following categories
of permissible exclusions under NAFTA and TRIPs:
2. Members may exclude from patentability inventions, the
prevention within their territory of the commercial
exploitation of which is necessary to protect ordre public or morality, including
to protect human, animal or plant life or health or to
avoid serious prejudice to the environment, provided that
such exclusion is not made merely because the exploitation
is prohibited by domestic law.
It is not certain what evidence would be needed to defend
such an exclusion, but the hurdle has clearly been set
very high.
Other kinds of exclusions from patentability are
permissible, as well:
3. Members may exclude from patentability:
-
diagnostic, therapeutic and surgical methods for the
treatment of humans or animals;
-
plants and animals other than microorganisms, and
essentially biological processes for the production
of plants or animals other than non-biological and
microbiological processes. However, members shall
provide for the protection of plant varieties either
by patents or by an effective suigeneris system or
by any combination thereof.
TRIPs provides for a review of plant variety protection
four years after the entry into force of the WTO
Agreement. That review will focus attention on how the
economic benefits of strong IP protection for crop plants
will be distributed, both within and among nations (see
Box 4). Canada has also signed the Convention on
Biological Diversity (CBD). The CBD established the
principle of national sovereignty over biological
resources, but set up no dispute resolution mechanisms
like those in NAFTA or the WTO Agreement. CBD does,
however, link technology transfer to recognition of
expansive intellectual property rights in biological
material – a provision that gave rise to many
objections from developing countries at the time the
agreement was being negotiated.
Quite apart from the letter of the law, intellectual
property policy and trade policy are increasingly
interconnected. Reciprocity is an important consideration
that underpins not only agreements like NAFTA and TRIPs,
but also the ongoing politics of trade. A trade-dependent
nation like Canada may not be able to make policy on
biotechnology patenting in isolation from the policies of
major trading partners – at least if our policy is
perceived as giving domestic industry a competitive
advantage. It may, therefore, be important to distinguish
between the policy toward patenting higher life forms and
human biological materials that we would prefer in an
ideal world and the one we would prefer given the need to
take into account the IP regimes in place elsewhere in the
world.
-
Ethical Questions About Patenting Higher
Life Forms and Human Biological Materials
-
First Steps
When considering the ethics of patenting higher life
forms, it is important to ask three sets of questions.
First: what principles, values or intuitions are at issue?
Second, do the ethical issues prima rily involve the
consequences of a particular application of biotechnology,
or of the issuing of a patent, or do they primarily
involve the intrinsic rightness or wrongness of a
particular action? In other words, are they primarily
deontological or consequentialist in form? (These terms
are explained in the next section of the paper.)
Third, how relevant is patenting to the concerns being
expressed or the outcomes being anticipated? Is patenting
really the issue, or are the concerns in que stion best
addressed in another way: for example through reg ulatory
controls on how a particular invention is marketed or
used?
An example serves to illustrate the interplay of these
questions. Wh en the Harvard mouse patent was issued in
the United States Sheldon Krimsky, who has written
extensively on the social and political controversies that
surround biotechnology, noted that the granting of the
patent suggested that “society was regressing to an
extreme Cartesian view of animals as soulless, unfeeling
creatures that may be treated like mach ine
parts.”12 The
value in question was respect for life, as reflected in
our ability to make the distinction between living,
sentient organisms and Cartesian machines. The concerns
expressed might have to do with the effects of patenting
and the associated commercial use of animals on public
attitudes and animal welfare, or they might reflect a
conviction that patenting in and of itself constitutes a
transgression against the value of respect for life. In
this case, patenting was clearly the issue: it was seen as
simultaneously reflecting and reinforcing a particular set
of unacceptable attitudes and beliefs. In other
situations, however, patenting may serve as a lightning
rod (some would say, a target of opportunity) for a
variety of apprehensions about the biotechnology
enterprise itself.
-
The Conceptual Framework: Forms
of Argument
Arguments for and against permitting patents on higher
life forms can be classified into two basic forms, each of
which draws on a long and distinct tradition in western
ethics or moral philosophy.
One form of argument, referred to by philosophers as
deontological (sometimes as ‘duty ethics’), appeals to duties, obligations, rights or principles that
supply the basis for evaluating an action, choice or
policy. A simple example is the axiom that one must always
treat other human beings as ends in themselves, rather
than as means to an end. When such axioms are invoked in
order to justify or reject a particular action, it is
usually important to ask about the source of such duties
or obligations: where do they come from?
Figure 1: Schematic View of the Ethical Issues
Associated with Patenting Higher Life Forms and Human
Biological Materials
Form of Argument
|
Primary Topic of Discussion
|
The biotechnology enterprise
|
Patenting
|
Deontological: arguments addressing inher ent or int
rinsic rightness or wrongness
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Pro: Advanced biological research fulfils
humanity's obligation to expand the range of
scientific knowledge, which is valuable its their
own right.
Con: Respect for life means that there are some
things we can do that we ought not to do; modifying
the genome of living organisms is one of these
things.
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Pro: Patenting higher life forms is required in
order to be fair to inventors and investors, who
otherwise will lose the opportunity to earn a
deserved return on their intellectual efforts and
financial commitments.
Con: The simple act of assigning intellectual
property rights to parts of the genome of livi ng
organisms denigrates them by equating them with mere
“manufactures or compositions of matter”
(the words of Canada’s Patent Act).
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Consequentialist: Arguments addressing harmful or
beneficial consequences
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Pro: Biological research will lead to new ways of
treating debilitating diseases; increases in crop
yields and livestock productivity will enable
humanity to produce more food at the same or
lower cost.
Con: Applications of agricultural biotechnology may
involve longterm risks (e.g. of gene transfer) that
are imperfectly understood; genetic screening will
invariably provide the basis for ethically
impermissible forms of discrimination.
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Pro: Expansive patent protection is needed to
encourage investment in a strong biotechnology
industry; without that incentive, the social
benefits will be slow to materialize, and/or the
economic ones will be captured by other
jurisdictions.
Con: Patenting will lead us to treat living
creatures as objects
(“objectification”); patenting may
actually discourage research by comparison with an
alternative scenario in which the relevant basic
research is publicly financed and results are placed
in the public domain.
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Source: Adapted from T. Schrecker, C.B.
Hoffmaster, M. Somerville and A. Wellington,
Biotechnology, Ethics and Government, Report to
the Interdepartmental Working Group on Ethics (Ottawa;
Industry Canada, 1998; completed 1996)
A second form of argument links the ethical status of an
action or policy with an assessment of its consequences:
hence the term consequentialist to describe such an
argument. The simplest and most familiar kind of
consequentialist position is utilitarianism, in
which the action that is right is the one that produces
the greatest good for the greatest number. How ‘the
good’ should be defined remains a top ic of
philosophical dispute. For many contemporary philosophers,
the consequences that must be taken into account in
ethical reasoning are environmental, social, economic or
even spiritual.
Distinctions between deontological and consequentialist
positions on patenting higher life forms and human
biological materials are indispensable for analytical
purposes because they demand clarity with respect to what
is being defended, or objected to. The distinctions also
have significant policy consequences. “If
deontological theorists are right, they can establish the
moral status of human activities – such as genetic
engineering – quite independently of the expected
consequences of those activities.”13 Conversely, consequentialist
arguments invite exploration of ways to mitigate the
undesired effects of a particular choice, and to enhance
the desired ones, in a way that deontological arguments do
not.
Figure 1 shows the importance both of the distinction
between these two forms of argument and of the distinction
between ethical arguments that add ress the biotechnology
enterprise as a whole and those that address issues
directly related to patenting.
In practice, ethical reasoning routinely and justifiably
combines the forms of argument, for at least two reasons.
First, the choice of whether to define consequences as
beneficial or harmful is not always self-evident, and
always takes place against a pre-existing ethical
background. Just identifying and listing consequences
tells us nothing about their ethical significance. Still
less does it tell us how best to balance a number of
potentially conflicting values, such as animal welfare and
potential advances in understanding human diseases.
Second, not only the nature of consequences, but also
their distribution may be ethically significant ... and
distribution can only be evaluated with reference to
principles of fairness or justice that are part of that
pre-existing ethical background. For example, it is
possible that the holders of a few patents on diagnostic
techniques based on molecular genetics could accumulate
fortunes while driving up costs to public health care
systems like Canada’s. In such a situation, we might
consider distributive justice as providing a sound case
either for limiting the intellectual property rights in
question or for redistributing the profits they generated
using some other policy instrument, such as a combination
of dedicated taxes and subsidies.
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The International Dimension
Redistributive polices of this kind are far more difficult
to implement when they would need to cross national
borders in order to achieve their intended objective . The
government of India, say, cannot tax a US corporation that
holds a crop plant patent, or a Swiss one that holds a
pharmaceutical patent; subsidies of many kinds are
increasingly likely to be the target of trade policy
objections. Building on this insight, several economists
point out that developing countries may have good reasons
to want different kinds of intellectual property
protection from industrialized countries. In particular,
knowledge-poor countries may be rich in biological
diversity and in botanical wisdom derived from traditional
or indigenous knowledge, both of which provide the
material for many patented inventions. Their industries
may have little to gain, at least in the short term, from
adopting rich-country standards of IP protection for
subject matter such as crop plants (Box 4), and their
populations may have much to lose if patented,
cutting-edge pharmaceuticals are only av ailable at price
s geared to the health care budgets of the industrialized
world.
Some of the strongest critiques of patent protection for
higher life forms and human biological materials are
therefore rooted in considerations of distributive justice
at the international level. The 1999 edition of the United
Nations’ Human Development Report warns
that new intellectual property rules may entrench the
industrialized world’s research agenda, in which
“money talks louder than need,” and make
technology transfer unaffordable14. On this view, harmonized
intellectual property protection may be one of several
reasons for a widening economic gap between knowledge-rich
and knowledge-poor countries. The 2000 Human
Development Report provocatively speculated that the
TRIPs agreement may actually be incompatible with
provisions of international human rights agreements that
recognize a right to share in scientific progress15.
Canada may not be able to do much about such situations by
way of domestic patent policy. However, our position in
future multilateral negotiations might be defined at least
partly with reference to such considerations of
distributive justice at the international level. We might,
for instance, argue that international agreements should
recognize and accommodate the differential impacts of
strong intellectual property protection regimes on
countries at different stages of economic development.
Note 4. Exhaustion of rights:
Historically, there have been no legal barriers for
farmers wishing to use saved seed for future crops
(‘farmer’s privilege’). However,
patent protection for plant varieties may extinguish
this right.
The prospect that agricultural input suppliers in the
industrialized world might take legal action against
farmers who have used saved seed for the next
year’s crops was an important factor contributing
to resistance to TRIPs in developing countries,
especially India, and to earlier versions of Directive
98/44 in the EU. The final version of the Directive
permits farmers to use saved seed from patented crop
plants, and the progeny of patented animals, in their
own agricultural operations but not to use them in
other ways for commercial purposes.
Such issues are likely to become progressively more
significant if in the future, as some observers
predict, most of the crops and livestock used in
commercial agriculture worldwide are bioengineered and
protected by patents or patent-like forms of
protection.
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Policy Options and Responses
For purposes of argument, let us assume that ethical and social
policy considerations have a legitimate place, somewhere, in
decisions about granting patents on higher life forms or human
biological materials. A number of legislative or regulatory
responses have been either proposed or tried; what follows is
not an exhaustive list.
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The Status Quo
Canada could make no changes to the Patent Act or
to existing CIPO policy. Resolution of such questions as
the nature of patentable sub ject matter would therefore
be left up to CIPO and the courts, based on the Patent
Act and relevant case law as they now stand. CBAC has
rejected this po sition, agre eing with the Federal Court
of Appeal that “Parliament, not the Courts, should
determine Canada’s policy with respect to the
patenting of higher life forms (and the distinction
between ‘lower’ and ‘higher’ life
forms).” What restrictions, if any, might Parliament
consider?
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Subject Matter Exclusions
Canada could amend the Patent Act either to allow
or to require CIPO to refuse patents on certain kinds of
subject matter. Were Canada to take this route, should the
exclusions be stated in general terms, or should they be
stated in terms of outright prohibitions on patents for
certain kinds of innovations?
Directive 98/44, which the EU thinks is compatible with
TRIPs, does both. Generic subject matter exclusions and
outright prohibitions on patenting certain kinds of
innovations are not mutually exclusive. However, either
category of exclusion must be compatible with the
provisions of NAFTA and TRIPs. Exclusions that appear to
single out biotechnology for special consideration will
need to be clearly defensible because of the prohibition
against discrimination as to the field of technology. A
national government’s say-so with respect to
categories of innovations that are unpatentable on grounds
related to “ordre
public or morality” is unlikely to be
decisive in the absence of considerable supporting
evidence and argument.
Subject matter exclusions raise challenges for drafting
and implementation, especially when stated in generic
terms. For example: who would decide whether or not the
commercial exploitation in Canada of a particular patent
would threaten “ordre
public or morality”: CIPO? The courts?
Since any refusal of a patent on such grounds would almost
certainly be challenged in the courts, we must be prepared
to consider how the courts would interpret the wording of
such exclusions. Is CIPO equipped to make such a
determination, even in the first instance? Can either
legislative drafting or the development of policy that
interprets subject matter exclusions be expected to keep
pace with the rapid advance of biological science?
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Opposition Procedures
In its Sixth Report (1998), the National
Biotechnology Advisory Committee recommended the
introduction of an opposition procedure with a six-month
time limit for commercial reasons: it would provide a way
for Canadian firms to challenge CIPO’s acceptance of
excessively broad patent claims without the expense of a
lawsuit to impeach the patent.
The legislated establishment of such a process is
logically independent from any incorporation of ethical or
other non-commercial concerns into Canadian patent law,
although if such a procedure existed it would probably be
used as a way of articulating those concerns. It is
therefore important to consider whether challengers on
‘public interest’ grounds would, or
should, be granted standing. In the United
States, where the courts are the only forum in which a
patent can normally be challenged, organizations objecting
to biotechnology patents on ‘public interest’
grounds have been denied standing. Under Canada’s
Patent Act, only the Attorney General of Canada
and those whose activities might leave them open to
lawsuits for patent infringement have standing to sue for
patent impeachment.
The administration of any opposition procedure would need
resources, as well as an organizational
‘home’. Is CIPO or any other federal agency,
as presently constituted, equipped to provide these?
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Infringement Exemptions and
Compulsory Licensing
As a response to concerns about the potential inhibiting
effects of patents on scientific research, infringement
exemptions constitute an alternative to outright subject
matter prohibitions. Canadian legal scholar Richard Gold
argues for expanding the conditions under which scientific
researchers may make use of human biological materials for
which patents have been granted or applied for, without
risking lawsuits for patent infringement. He has also
suggested the introduction of a regime of compulsory
licensing for certain kinds of research tools, such as
genes and cell lines. This would “prevent
prohibitive or anti-competitive licensing terms with
respect to basic technology.” Such changes, says
Gold, “can be accommodated within existing patent
law.”16
Compulsory licensing has also been proposed as a way of
controlling the costs of patented drugs and diagnostic
techniques, perhaps as an alternative to price controls at
the national level. Indeed, Canada had provisions for
compulsory licensing until the early 1990s for this
reason. Here as in other areas of IP protection, trade law
and policy constraints a re important. Articles 30 and 31
of TRIPs seriously restrict the conditions under which
infringement exemptions or compulsory licensing may be
used. For instance, “exceptions to the exclusive
rights conferred by a patent” are only permissible
if they
... do not unreasonably conflict with a normal
exploitation of the patent and do not unreasonably
prejudice the legitimate interests of the patent owner,
taking account of the legitimate interests of third
parties.
Compulsory licensing is only permissible after
“efforts [have been made] to obtain authorization
from the right holder on reasonable commercial terms and
conditions,” and must be accompanied by
“adequate remuneration in the circumstances of each
case, taking into account the economic value of the
authorization”.
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Upstream Conditions
Biological material used in research that generates patent
applications is obtained in many ways. Human materials may
be obtained in the course of field research, diagnosis or
treatment, from people who are unaware of their subsequent
use. The Moore case (see Box 5) exemplifies such
a situation. Non-human materials may have been obtained in
the course of bioprospecting, or from collections of
biological material that are in the public domain.
What standards of consent, confidentiality and sharing of
commercial revenues are ethically appropriate in these
situations? What role, if any, should the patent system
play in ensuring that such standards are maintained? One
approach to such questions involves specifying upstream
conditions. For example, patent applicants might be
required to submit ethics approvals before receiving
patents on certain kinds of subject matter, just as
university-based researchers must receive approval from
their institution’s Research Ethics Board (REB)
before Canada’s federal granting councils will
support rese arch involving human subjects.
Note 5. Confidentiality, informed consent, and
ownership of human biological materials: The
question of who owns human biological materials
obtained during diagnosis or therapy came to public
attention because of the case of John Moore, a
California man whose spleen was removed in 1976.
Moore’s oncologist and other researchers then
cultured cells from Moore’s cancerous spleen that
produced a class of substances (lymphokines) with
considerable therapeutic (and therefore commercial)
potential. They obtained a patent on the cell line,
from which both they and the University expected to
earn substantial royalties. After learning about these
developments, Moore sued both the oncologist and the
university for a share of the royalties from the
patent. His claim was ultimately rejected by the
courts.
More recently, bioethicists have devoted considerable
attention to requirements f or informed consent as they
apply to research uses of human biological materials.
Key questions include: the circumstances under which
identifiers may (or must) be removed; whether, or under
what circumstances, commercial use of either such
anonymized samples of biological material or of
identifiable samples collected during prospective
research is permissible; whether research subjects may
(or must) share in the revenues from such uses; and how
research that identifies genetic characteristics that
occur more frequently among members of a particular
ethnic group might result in the stigmatization of all
members of the group.
The Human Genome Diversity Project (HGDP), a loosely
organized international collaboration of scientists who
share the aim of surveying genetic diversity among the
world’s human populations, has been the target of
intense criticism for lack of foresight on these
questions. In response, project researchers have
developed a detailed model protocol for collection of
human DNA samples that recognizes the importance of
such issues as disclosure of possible comm ercial uses
and cultural differences in the relativ e significance
of group and individual consent to participation in
research.
Standards for ethical review required as a precondition
for the grant of a patent might be relatively general in
nature. Alternatively, specific reference could be made to
such documents as the Canadian Council on Animal Care
Guidelines on Transgenic Animals; the new
Tri- Council Policy Statement on Canadian
federally funded research involving human subjects,17 or the model protocol
for collecting human DNA samples developed for the HGDP.18 In addition, patent
applicants might be required to demonstrate compliance
with provisions of the CBD requiring that: “Access
to genetic resources shall be subject to prior informed
consent of the Contracting Party” – meaning
the national government within whose jurisdiction the
resources were obtained. Upstream requirements would thus
use Canadian intellectual property law to achieve outcomes
that reflect the spirit of Canadian commitments in
superficially unrelated areas, such as animal welfare, the
protection of human research subjects and the protection
of biodiversity.
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Regulation, Old and New
Most, if not all of the preceding responses would require
changes both in the Patent Act and to the practices of the
agencies that administer it. However, it has been argued
that ethical concerns about the patenting of higher life
forms and human biological materials, although legitimate,
are best addressed in other areas of law and public
policy, or by institutions that have no direct connection
with IP.
We therefore need to ask the always-contentious question
of whether Canada’s existing statutes, procedures
and institutions can credibly articulate the ‘public
interest’ with respect to the emerging capabilities
of biological science. Perhaps not surprisingly, the key
players in some existing institutions tend to say yes. On
the other hand, political theorist William Leiss has
argued that “the creation of transgenic entities
through science and engineering is a sufficiently
distinctive process that it could itself be the subject of
a regulatory agenda under separate legislation,”
with a separate agency administered jointly by Health
Canada and Environment Canada.19 In its November 1996 report
on regulating biotechnology, the House of Commons
Committee on the Environment and Sustainable Development
recommended further study of proposals for such an agency.
Regulatory issues are complicated. Organizations as
dissimilar as the Canadian Food Inspection Agency (CFIA),
which is responsible for enforcing federal food safety
standards, and the REBs that approve research protocols
within each Canadian university, can all be thought of as
regulators for purposes of some applications of
biotechnology. Partly for this reason, the present paper
does not provide a complete list of such institutions, and
of course does not assess their adequacy. Such issues
nevertheless need to be explored, because without doing so
it is impossible to answer a key question: Do the ethical
issues associated with patenting higher life forms and
human biological material require fundamental changes in
Canadian patent law, or can they be addressed by
“minor tweaks” (in the words of one reviewer
of an earlier draft of this paper) in combination with
policy initiatives in other areas?
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Conclusion
Patent law is meant to provide social benefits by encouraging
scientific and commercial creativity; recognizing the fruits of
inventive activity; and, crucially, enriching the public domain.
Some critics of patenting call into question whether those
benefits could, or would, be realized with the advent of patents
for higher life forms and human biological materials. Other
critics assert that the inherent wrongness of IP rights
involving certain kinds of living matter supersedes any conside
ration of benefits. Conversely, proponents of patenting insist
that the field of biotechnology is especially appropriate for
the incentive framework and reward structure provided by
patents.
Canadian debates over the merits and demerits of patents for
higher life forms and human biological materials are just
beginning, in many ways. The positions people take on the issues
tend to reflect a variety of influences, including their views
about what the balance between public investment in research and
reliance upon typically profit-driven commercial investment
should look like. Thus public discussion of biotechnology
patenting issues will unavoidably touch on broader issues of the
appropriate relation among science, business and society. This
is almost certainly a good thing.
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Resources: For Further Information
The web site of the Canadian Biotechnology Advisory Committee
(
http://cbac-cccb.ca/) offers an expanding range of
information about the Committee’s work on biotechnology
related issues, as well as the reports of research commissioned
by the Committee.
The Biotechnology Gateway on Industry Canada’s Strategis
web site, (
http://strategis.ic.gc.ca/epic/site/lsg-pdsv.nsf/en/Home),
offers access to information on many aspects of Canada’s
biotechnology industry.
Trade and intellectual property issues often intersect.
Canada’s Department of Foreign Affairs and International
Trade (DFAIT) offers a range of information on such topics as
trade negotiations and agreements, why trade matters and current
trade policy issues. Go to (http://www.dfait.gc.ca/).
A web site maintained by the University of Pennsylvania’s
Center for Bioethics, (http://www.bioethics.net), is a
particularly useful gateway for information and late breaking
news on biotechnology patenting in the United States.
The web site of the European Patent Office, (http://www.european-patent-office.org/index.htm),
provides extensive links to official documents related to
patents in the EPC countries.
Some of the best European reporting on biotechnology issues can
be found in The Guardian; go to (http://guardianunlimited.co.uk/genes).
The web site of the World Trade Organization, (http://www.wto.org) is an excellent
source on trade policy, including trade related aspects of
intellectual property rights.
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* Consultant, 450, rue de la
Congrégation, Montréal, Québec H3K 2H7
Phone: 514 932 5386 - Fax: 514 932 5230 - E-mail: tschrecker@sympatico.ca
Associate Member, McGill Centre for Medicine, Ethics and Law
3690 Peel Street, Montréal, Québec H3A 1W9 Phone: 514
398 7407
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** Department of Philosophy, Ryerson Polytechnic
University,
350 Victoria Street, Toronto, Ontario M5B 2K3
Phone: 416 516 4808 - Fax: 416 535 1093 - E-mail: alex.wellington@sympatico.ca
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1 For purposes of this document, “higher life
forms” are defined as multicellular organisms, and
“human biological materials” as biological materials or
products of human origin or intended for incorporation into the
human phenotype or genotype, including but not necessarily limited
to DNA sequences, cell lines, tissues, and organs.
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2 G.B. Doern, Global Change and Intellectual
Property Agencies: An International Perspective (London:
Pinter, 1999), at 6.
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3 J. Locke, Two Treatises on Government (1698),
Book 1, ¶42; see also Book 2, ¶26-36, 134.
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4 G. Strachan, “Patents: The Lifeblood of the
Evolving Canadian Biopharmaceutical Sector,” speech to CPIC,
November 27, 1996.
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5 M Heller and R. Eisenberg, “Can Patents Deter
Innovation? The Anticommons in Biomedical Research,” 280
Science (1998) 698.
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6 Re application of Abitibi Co. (1982), 62
C.P.R. (2d) 81.
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7 B.M. Knoppers, “St atus, Sale and Patenting of
Hum an Genetic Material: An International Survey,” 22
Nature Genetics (May, 1999) 23, at 25.
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8 President and Fellows of Harvard College v. Canada
(Commissioner of Patents) (C.A.), [2000] 4 F.C. 528. The full
text of the decision, which includes a detailed history of the
patent application in both Canada and the United States, is
available electronically at (http://www.fja.gc.ca/home/index_e.html).
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9 The sardonically minded might wonder whether these
Canadians regard Calvin Klein advertisements as unacceptable for
similar reasons, and what – if anything – they think
public policy should do by way of a response.
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10 The text of the EPC is available on the European
Patent Office web site at (http://www.european-patent-office.org/legal/epc/index.html).
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11 Report on the 80th Meeting of the Administrative
Council (6-8 June 2000), 7 Official Journal of the European
Patent Organization (July); (
http://www.european-patent-office.org/epo/pubs/oj000/7_00/7_3070.pdf).
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12 S. Krimsky, Biotechnics & Society: The Rise
of Industrial Genetics (New York: Praeger, 1991), at 49.
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13 M. Häyry, “Categorical Objections to
Genetic Engineering -- A Critique,” in A. Dyson and J.
Harris, eds., Ethics and Biotechnology (London: Routledge,
1994), at 202.
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14 United Nations Development Programme, Human
Development Report 1999: Globalization with a Human Face (New
York: Oxford University Press, 1999), at 66-72.
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15 United Nations Development Programme, Human
Development Report 2000: Human Rights and Human Development
(New York: Oxford University Press, 2000) at 84.
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16 E.R. Gold, “Making Room: Reintegrating Basic
Research, Health Policy, and Ethics into Patent Law,” in T.
Caulfield and B. Williams-Jones, eds., The Commercialization of
Genetic Research: Ethical, Legal, and Policy Issues (New York:
Plenum, 1999) at 72.
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17 Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans, available at (
http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm).
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18 “Model Protocol: Proposed Model Ethical
Protocol for Collecting DNA Samples,” Houston Law
Review 33 (1997): 1431-73.
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19 W. Leiss, in Minutes of Proceedings and
Evidence, House of Commons Standing Committee on Environment
and Sustainable Development (June 11, 1996).
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