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2001
Human Rights Issues in Patenting of Higher Life Forms - The Role of the Canadian Charter of Rights and Freedoms (disponible en anglais seulement)
Ce document est présenté dans la langue dans
laquelle il a été fourni par l'auteur ou la
source
Prepared For
The Canadian Biotechnology Advisory Committee Project Steering
Committee on Intellectual Property and the Patenting of Higher Life
Forms
By Barbara von Tigerstrom, B.A., M.A., LL.B. 1
February 2001
Table of Contents
-
Introduction
-
Human rights issues related to patenting
of human materials
-
Patenting of human materials
-
Patent rights as an infringement of individual
rights
-
Patenting and slavery
-
Scope of Charter rights
-
Patent rights and the Charter
-
Addressing Human Rights Issues: Options for
Consideration
-
Modifying Patent Law to Protect
Individuals’ Charter Rights
-
Options for Addressing Other Human Rights
Issues
-
Conclusions and recommendations
Executive Summary
The patenting of human materials has raised a number of human rights
concerns, ranging from issues regarding benefit from research, to the
rights of research subjects, to the protection of individual privacy.
Some have suggested that patents on human beings or other human
biological materials may directly infringe human rights and that
patent rights are incompatible with the prohibition of slavery and the
protection of individual liberty. A patent holder has the right to
exclude any other person from making, using or selling the invention.
These rights do not amount to ownership, but the patent holder’s
exclusive rights are limited property rights which might, in certain
circumstances, fall within the definition of slavery or otherwise be
contrary to recognized human rights. This paper seeks to identify
whether there are any cases in which patents on human materials may
result in a violation of the rights of individuals protected in the
Canadian Charter of Rights and Freedoms, in particular the
guarantee of life, liberty and security of the person in section 7,
and to a lesser extent equality rights in section 15(1).
The right to reproductive autonomy falls within the scope of section 7
of the Charter. The patentee’s exclusive right to make
an invention potentially conflicts with this right and equality rights
when the invention is one that can be “made” through
natural reproduction: for example human beings and germ line genetic
interventions. The exclusive right to use the invention probably would
not, even in the case of a patent on a human being, interfere with an
individual’s usual activities. A patentee might attempt to
prevent others’ use of a human being or other human material for
research or other purposes, which might violate rights under section 7
or 15(1). In certain cases a particular means of enforcing the
exclusive right of use (for example an injunction affecting an
individual’s person) might infringe Charter rights.
Finally, the exclusive right to sell has no application in the case of
a patented human being; in addition some tissues cannot be sold under
current law. However, in cases where human biological material could
be sold, the patentee would have the exclusive right to sell and could
prevent anyone else from doing so. The right to sell one’s
biological material is not as well protected under the
Charter, although one could argue that equality rights are
violated by a restriction which applies only to certain classes of
individuals.
There are therefore a few cases in which the grant of a patent or the
enforcement of patent rights might directly infringe an
individual’s Charter rights. The prospect of a patent
on a human being raises the most serious concerns but a human being is
almost certainly not patentable under current law in any case. Patents
on human materials such as genes and proteins do not raise concerns
about interference with individual rights although they may raise
other human rights concerns.
Patent law may be modified either by legislative or judicial action to
eliminate these potential conflicts with individual rights. One option
for modifying patent law would be to exclude certain material from
patentability. Some other jurisdictions have excluded human beings or
provided general exclusions based on “ordre public and
morality.” Another option would be to avoid any restrictions on
what is patentable (beyond the current criteria), but to restrict the
exercise of patentees’ rights where these may interfere with
individual human rights. The second option might be preferable since
it entails minimal interference with the patent system, except in the
case of human beings where patent rights would be problematic in many
respects and an exclusion may be advisable. Any modification of the
patent system will have to take account of
international trade law obligations regarding patent protection.
A broader range of measures will be required to address other human
rights concerns, including those relating the equitable distribution
of benefits from research and resulting patents. Measures requiring
further consideration may include modifications to the patent system,
but also the development of other norms and regulatory mechanisms at a
national and international level.
-
Introduction
The patenting of human materials has raised a variety of legal
and ethical concerns, including some relating to human rights.
Distinct questions involving human rights are raised by the
technology and purposes underlying attempts to patent human
materials. However, there are other concerns that are specific
to patenting. Identifying these issues and recognizing the
distinctions between them is essential, since it is only by
precisely identifying potential issues that we can formulate
appropriate solutions.
-
Human rights issues related to
patenting of human materials
A range of human rights issues or concerns relating to
patenting human materials has been identified.2 First, there are concerns
that patenting human materials may lead to violations of
the right to health and to benefit from the applications
of scientific progress. Some believe that the patent
system may impede research, by restricting the exchange of
information and/or by making research prohibitively
expensive due to the need for researchers to acquire
rights from patent holders to use research materials.
There is also a concern that because of the limited
monopoly that a patent creates, the cost of therapeutic
applications will prevent equitable access to the benefits
of scientific research. The availability of patents may
also play a role in directing research interests
disproportionately toward commercially profitable areas
and away from others which could provide important
benefits to individuals.
Second, there are also specific concerns relating to the
rights of individuals used as research subjects, including
claims to receive some benefit from patented inventions
that may result from their participation and the
protection of their rights to autonomy and physical
integrity during the research itself. Individuals or
groups who are used as research subjects may also have
concerns about the protection of their privacy, especially
relating to genetic information, and protection from
related discrimination. Issues regarding collective rights
may be raised where distinct groups or populations
participate as research subjects.
Finally, it must be asked to what extent the grant of
patent rights on certain human materials might directly
infringe the liberty, security of the person or equality
of any individual. It is this last question which will be
the primary focus of this paper. The possibility that
patents on certain human materials might constitute a
direct violation of individual rights must be
investigated, because it has important implications for
the measures which might be required to protect rights.
-
Patenting of human materials
Before moving on to a discussion of these questions, it is
important to clarify the scope of the subject matter at
issue and its current status in Canadian law. “Human
materials” will be used generally to refer to human
beings, human embryos, and elements or products of the
human body including human organs and tissues, cell lines,
genetic material and proteins. We will also be concerned
with processes by which any of these are created or
modified, since processes themselves may also be patented.
It has been the law in the United States3 and Canada4 since the 1980s that living
organisms produced by human intervention may be the
subject of a patent. Generally, human material will be
patentable when it constitutes an invention within the
meaning of the Patent Act5 and meets the usual criteria
of novelty, non-obviousness and utility.6 These requirements narrow the
scope of patentable subject matter: for example, a
discovery is not patentable, nor are human materials in
their naturally occurring form. However, elements of the
human body such as genes and proteins may be patentable if
they are isolated and purified; cell lines and hybridomas
are also patentable.
Previously, higher life forms of any kind could not be
patented in Canada, but a decision of the Federal Court of
Appeal recently found that transgenic non-human mammals
are patentable.7 This
holding is limited to non-human animals, however:
“the Patent Act cannot be extended to cover human
beings.”8 Some
reasons for this will be explored in the next section. It
could also be said that human beings cannot be patentable
inventions because they would not meet the utility
requirement. The requirement that an invention be
“useful” means that it must have some
“industrial value.”9 This normally means that it
will have some prospect of commercial exploitation
(although commercial success or lack of it does not
necessarily prove whether the invention is useful).10 To apply this
definition to a human being would be to stretch it beyond
a reasonable interpretation.11 Furthermore, an invention
with an immoral or unlawful purpose, or one which is
dangerous, is not useful in the sense required by the
patent system12 and
proposed uses of human beings for industrial or commercial
purposes would almost certainly fall in this category.
Patents on human beings will nevertheless be considered
below for the sake of discussion. This discussion is
limited to subject matter which otherwise meets the
criteria for patentability and involves human intervention
similar to that for other higher life forms, such as human
beings produced through cloning, or genetically modified
or transgenic human beings.13 It should be borne in mind,
however, that it is unlikely that a patent would ever be
granted for a human being, even if these other conditions
were met.
-
Patent rights as an infringement of
individual rights
Some authorities have taken the position that patent rights
relating to a human being constitute an impermissible
infringement of personal liberty. The U.S. Patent and Trademark
Office (USPTO) has stated that a claim “directed to or
containing within its scope a human being will not be considered
to be patentable subject matter” because “[t]he
grant of a limited, but exclusive property right in a human
being is prohibited by the Constitution.” 14 Similarly, the majority judgment
of the Canadian Federal Court of Appeal in the recent decision
allowing patents on higher life forms contains the following
statement:
A final question is whether the Patent Act could be extended to
cover human beings. In other words, could a finding that
“invention” includes living organisms extend to
human beings? For example, on a theoretical level, could a
person whose genome has been modified by the addition of an
engineered gene in order to eliminate or suppress a genetic
predisposition to a disease be the subject matter of a
patent?
...
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.
There are undoubtedly other bases for so concluding, but one is
surely section 7 of the Charter of Rights and Freedoms which
protects liberty. 15
-
Patenting and slavery
The specific constitutional basis for the USPTO’s
position has been assumed to be the Thirteenth Amendment
of the U.S. Constitution which prohibits slavery.16 The legal commentators in
the U.S. who have examined this statement seem unanimous
in concluding it is wrong, at least insofar as it relies
on the Thirteenth Amendment.17 As one put it: “the
legal basis for the PTO position is flawed; there is no
reason to suppose that the Thirteenth Amendment addresses
the type of right conferred by a patent.”18 At least two commentators
have concluded that a patent on a human being is not
unconstitutional at all.19
The basis on which the USPTO’s position is
questioned is that a patent right does not equate to
ownership, therefore a patent on a human being would not
constitute slavery. The patent holder has the right only
to exclude others from making, using or selling the
invention and does not (at least not necessarily or merely
by virtue of owning the patent) own individual embodiments
of the invention.20
However, it would be surprising, to say the least, if the
Commissioner of the USPTO misunderstood the nature of the
rights granted by a patent. Clearly the USPTO must know
that a patent does not equate to ownership of the
invention, but understands that it does confer a
“limited, but exclusive property
right”. The comments of the Canadian Federal Court
of Appeal similarly refer to patents as a form of
property, but it is unlikely that this is because the
Court mistakenly believes that patents are equivalent to
ownership. Therefore, the crux of the issue must lie
elsewhere. We know that we are not concerned here with
outright ownership of a human being, but we need to
examine the rights that are granted to a patent holder and
what effect they might have on individuals’ rights.
To begin with, the definition of slavery, at least in the
international legal instruments that are relevant to
Canada,21 includes more
than what we might understand as ownership of a human
being. Slavery is defined as “the status or
condition of a person over whom any or all of the
powers attaching to the right of ownership are
exercised.”22
Property is a “bundle of rights” which
includes, for example, the right to possess, use or earn
income from something.23 The exclusive right to use
an invention might therefore be described as one of the
“powers attaching to the right of ownership.”
A patent gives its owner the exclusive right to make, use
and sell the invention, which is sometimes explained as
being no more than the right to exclude others from
making, using or selling the invention. However, the same
could be said of property generally: the concept of
property has been described as “a state-enforced
right of exclusion over things, good (generally) against
the world.”24 An
owner may not be able to use her property as she likes,
but she still owns it and can legally prevent others from
using it.
There is, of course, a difference between owning a patent
on an invention and owning the product or embodiment of
the invention, and the two do not necessarily go together.
The key point here is that the nature of these rights is
perhaps not as different as some would suggest. It is
therefore conceivable, at least in theory, that patent
rights in a human being could amount to a power of
ownership sufficient to meet the definition of slavery in
international law. Whether this is the case will depend on
whether the patent owner can, as a result of the patent
rights, exercise control over an individual and on the
nature and degree of any such control. For our purposes,
in the context of the Charter, the question of
control is also central. There is no specific prohibition
against slavery in the Canadian Constitution, but the
Charter does protect individual liberty and security of
the person under section 7 and equality rights under
section 15(1). Therefore, we can most usefully advance the
analysis by asking whether patent rights might in some
cases interfere with individual liberty, security of the
person, or equality, regardless of whether we would
characterize this interference as a form of ownership.
-
Scope of Charter rights
Section 7 of the Charter is particularly relevant
in this context because it protects individuals’
right to liberty and security of the person. The section
states: “Everyone has the right to life, liberty and
security of the person and the right not be deprived
thereof except in accordance with the principles of
fundamental justice.” The claimant must establish
first that there has been a deprivation of life, liberty
or security of the person, and second, that this
deprivation is not in accordance with the principles of
fundamental justice. If both of these are established, the
government must justify the violation under section 1.25
The liberty interest protected by section 7 includes
freedom from physical restraint such as imprisonment, or
requirements to submit to fingerprinting or to produce
documents.26 It also
protects an individual’s right to make decisions
about personal matters of fundamental importance free from
state interference.27
This “narrow sphere of inherently personal
decisionmaking” 28 may include matters such as
one’s choice of a place of residence,29 decisions to consent to or
refuse medical treatment,30 and decisions about
reproduction.31 Section
7 does not, however, guarantee absolute freedom from any
constraint.32
Furthermore, it does not, as a general rule, include
economic freedoms such as the right to engage in business
or a profession,33 nor
does it cover the freedoms that are protected elsewhere in
the Charter such as freedom of conscience,
expression and association, or mobility rights.34
The right to control one’s own body is also
protected by the right to security of the person in
section 7.35 Security
of the person is infringed not only by harm to one’s
health or physical integrity, but also by a loss of
control over one’s body, for example regarding
termination of a pregnancy.36 “On this basis,
security of the person would include some requirement of
personal autonomy, at least with respect to medical
treatment.”37 In
addition, it protects psychological as well as physical
integrity38 and
therefore is offended where there is, objectively, a
“serious and profound effect on a person’s
psychological integrity.”39 For example, invasion of
privacy, stigmatization, and disruption of family
relationships may violate one’s security of the
person.40 Generally
speaking, however, section 7 does not protect social or
economic security, or security of one’s personal
property.41 Finally, it
does not include a generalized right to dignity, although
human dignity is an important underlying value of the
Charter.42
A violation of the right to liberty or security of the
person will not amount to a violation of section 7 which
must be justified under section 1 of the Charter,
unless is it contrary to the principles of fundamental
justice. The principles of fundamental justice are the
“fundamental principles of our legal system,”
both substantive and procedural.43 These principles include
aspects of procedural fairness and the right to a fair
trial, and lack of unfairness,44 arbitrariness,45 vagueness46 or overbreadth.47 In Rodriguez,48 a majority of the
Supreme Court of Canada held that respect for human
dignity, while a principle underlying our society, is not
a principle of fundamental justice; however, respect for
human life is a principle of fundamental justice. The
Supreme Court has also held that protection of a
child’s right to life and health is a principle of
fundamental justice.49
The analysis may also involve a substantive balancing of
the individual’s interests and the interests of
society.50
The primary focus of this paper is on section 7 of the
Charter, but other sections may also be relevant,
including in particular section 15(1) which protects the
right to equality before and under the law and the equal
protection and benefit of the law. There is no rigid
formula for the analysis of claims under section 15(1),
but the Supreme Court of Canada has recently articulated
the following guidelines: 51
-
Does the impugned law (a) draw a formal distinction
between the claimant and others on the basis of one or
more personal characteristics, or (b) fail to take into
account the claimant’s already disadvantaged
position within Canadian society resulting in
substantively differential treatment between the
claimant and others on the basis of one or more
personal characteristics?
-
Is the claimant subject to differential treatment based
on one or more of the enumerated and analogous
grounds?
and
-
Does the differential treatment discriminate, by
imposing a burden upon or withholding a benefit from
the claimant in a manner which reflects the
stereotypical application of presumed group or personal
characteristics, or which otherwise has the effect of
perpetuating or promoting the view that the individual
is less capable or worthy of recognition or value as a
human being or as a member of Canadian society, equally
deserving of concern, respect, and consideration?
Some possible claims under section 15(1) will be
considered at various points below.52
-
Patent rights and the
Charter
As federal legislation, the Patent Act is clearly
subject to the Charter,53 and if it is inconsistent
with the Charter, is of no force and effect to
the extent of that inconsistency.54 The act of issuing a patent
is also a government action to which the Charter
would apply. Where a patentee attempts to enforce patent
rights against an alleged infringer, the latter could
invoke the Charter to argue that the patent
rights infringe his or her constitutional rights.55
In order to identify possible Charter violations
it is essential to understand the nature of a patent and
the rights that are granted to a patent holder. The
significance of granting a patent on certain human
material cannot be appreciated without knowing what a
patent entails and assessing the effect of the patent
rights. It might be argued that the mere fact of granting
a patent on a human being or certain human material
infringes the liberty, security or equality rights of
affected individuals, either because of some psychological
effect from knowing that one is potentially affected by a
patent, or because the existence of a patent means that
the law has a differential impact on those individuals.
However, any psychological effect – even if it might
reach the threshold of serious state-imposed psychological
harm required to trigger section 7, which seems somewhat
doubtful – can only be fully assessed in terms of
what the existence of a patent actually means. Similarly,
it would be difficult to determine whether there is any
violation of equality rights without understanding the
potential impact of a patent.
A patent gives the patentee “the exclusive right,
privilege and liberty of making, constructing and using
the invention and selling it to others to be
used.”56 In
essence this is the right to exclude others from making,
using or selling the invention. The patent holder will not
necessarily have the right to undertake these activities
(they may be subject to regulation or even prohibition by
law), but may prevent anyone else from doing so during the
term of the patent. A patent is infringed whenever someone
interferes with the patentee’s monopoly without
consent.57 It does not
matter whether the infringer intended to infringe the
patent or even was unaware of the patent, and the
infringer need not have benefited financially from the
infringement,58
although purely private acts with no commercial purpose
may not be infringements.59 The remedies available
against an alleged infringer include damages60 and an injunction to prevent
the use, manufacture or sale of the subject-matter of the
patent.61
-
Reproduction as
“making” an invention
The advent of patents on living organisms raises the
possibility of reproduction as patent infringement.
One of the exclusive rights of the patentee is to
make the invention. Where the invention is a living
organism, it can be made through reproduction.
“To breed descendants of a patented transgenic
animal without license is as much infringement as
would be duplicating a patented laboratory process
of inserting transgenes into an embryo. The patent
system assimilates reproduction, whether natural or
artificially aided, to ‘making’ a
duplicate.”62 This is crucial to the
protection of the patentee’s exclusive rights
when the invention concerns a transgenic animal,
because if the inventor could patent only the
process by which the animals were originally
produced, any person who gained possession of the
animals could breed them to produce more without
requiring a license or paying any compensation to
the patentee of the process. The availability of
patents on living organisms as products as well as
the processes by which they are created is in part
designed to provide this protection to the
inventor.63
However, when this same logic is applied to humans
as inventions as opposed to non-human animals, the
possibility of control over reproduction raises
human rights concerns. Our society generally accepts
that the reproduction of non-human animals may be
controlled by humans, but human beings have the
right to make reproductive decisions for themselves
without interference as part of their personal
autonomy, a right which is within the scope
protected by section 7 of the Charter.64 The concern has been
raised that the grant of an exclusive right to make
an invention could interfere with an
individual’s reproductive freedom.65 It may seem
“perverse” to “call human birth or
life an ‘infringement’”66 but a patent on a
human being would make this possible, at least in
theory.67
If, by virtue of a patent, a patentee obtained the
right to prevent an individual from reproducing,
this would seem clearly to offend the protected
right to liberty and security of the person.
Imposing this constraint on some individuals likely
would offend their equality rights as well, if they
could establish a connection to some enumerated or
analogous ground. It remains to be determined, then,
what types of patents might potentially produce this
result. One would be a transgenic human being, by
analogy with patents on transgenic non-human
animals. If the patent was on the transgenic human
as a product, and not just the process, then even
natural reproduction could be an infringement.
Another would be a germ line genetic intervention in
a human. A germ line intervention would be passed
down to the recipient’s offspring and thus
reproduction could constitute an infringement.
-
Transgenic non-human animals are designed and
produced to be used by humans, in particular for
research. It is difficult to conceptualize what
“use” would mean in the context of a
human being as invention. One commentator has
suggested:
A patent holder has the right to exclude others from
using his or her invention. But a human being is
autonomous; he or she is the only person who can
‘use’ himself or herself through
participation in activities, striving for goals and
making contributions to society. The patent holder
would be prevented from controlling the altered
person’s activities by the thirteenth
amendment proscription against involuntary
servitude. If the patent holder tried to prevent
others from interacting with the altered person, he
or she would violate the right to freedom of
association, which is also constitutionally
protected. 68
Another author has suggested that the exclusive
right to use, if applied to human beings, could
interfere with an individual’s right to earn a
livelihood, the right to life, liberty and property
in the Fifth Amendment of the U.S. Constitution and
the Thirteenth Amendment prohibition on slavery and
involuntary servitude.69
As noted earlier, the idea that no one other than
each individual him- or herself can
“use” a human being undermines the
possibility of patenting a human being as a useful
invention. If we accept that a human being could be
a patentable invention, it still seems unlikely that
the actions of an individual in going about his or
her daily life, pursuing goals and associating with
other people would fall within the scope of
“use” of an invention as intended in the
Patent Act. To “use” an
invention is to put it to use for its intended
purpose. If someone wanted to use a patented article
for some purpose totally unrelated to the purpose
for which it was designed, it is difficult to see
what cause the patentee would have to object. If
personal activities of a human being were
considered to be “use” of the invention,
attempts to interfere with the personal decisions of
an individual would probably violate the right to
liberty. There are some limits to this, however: for
example, section 7 does not, as a general rule,
protect the right to pursue a certain occupation or
profession. Freedom of association is protected in
section 2(d) of the Charter, but this
section has a restricted scope.70
If human beings could be patentable inventions, by
analogy to transgenic non-human animals, the likely
uses for which they might be designed might include
research or the provision of organs and tissues for
transplant. It is conceivable that a patent holder
might want to have a transgenic or genetically
modified human participate in research, to test or
improve the invention, and that this might fall
within the scope of “use” of the
invention. Any attempt to compel such participation,
however, would run into several legal obstacles. The
individual’s right to consent or refuse to
participate in medical research is protected by the
common law,71
ethical guidelines,72 international human
rights law73 and
the Charter.74 A patent holder
clearly would not be able to require an individual
to participate in research without that
individual’s free and informed consent. A
similar analysis would apply to other medical
procedures, including the taking of organs or
tissues for transplant or other purposes.
A patent holder might also want to gain information
from or about an individual, for research purposes,
as part of the “use” of the invention.
Personal information such as information about the
individual’s health would be subject to the
individual’s right to privacy which is
protected in international human rights law75 and under sections 7
and 8 of the Charter.76 Any attempt to gain
information about an individual without her consent
would potentially violate these rights.
The preceding discussion deals with use by the
patentee. What is granted by the patent, however, is
the right to exclude others from using the
invention. The patent holder might also want to
prevent an individual from participating in research
by a competitor, providing personal information to a
competitor or from providing any biological material
to a competitor as part of the right of exclusive
use. While it is not difficult to conclude that a
patentee cannot force an individual to participate
in research or to allow tissue or organs to be
removed without the individual’s consent, the
question of whether the patentee could restrain the
individual from engaging in these activities with
others is more problematic. The common law and
Charter rights just discussed do not
necessarily include the affirmative right to receive
treatment, participate in research, donate or sell
biological material or disclose personal information
to specific persons. Where participating in research
or undertaking some other activity with someone
other than the patentee was necessary for the
protection of the individual’s life or health,
then an attempt to prevent this would likely be an
interference with security of the person. It is also
possible that attempts to interfere with these
actions by an individual would be a violation of the
right to liberty which protects fundamental personal
decisions. However, the arguments under section 7
are not as clear in this context as in the case of
forced participation. The individual could further
argue that enforcement of the patentee’s
rights in this context would violate the right to
equality in section 15(1) of the Charter,
given that they would impose restrictions on the
individual’s activities that are not suffered
by others. Freedom of association might also be
invoked, although likely with less success given
that the scope of s. 2(d) in the Charter is
quite narrow.77
In some instances, patent rights relating to use may
be generally unobjectionable but specific means of
enforcing these rights give rise to human rights
concerns. For example, there might be cases in which
the use of a patented invention is related to
reproduction and therefore implicates the right to
reproductive autonomy. Where a patent concerns a
process for some reproductive technology (e.g. human
cloning) or intervention relating to an embryo or
fetus (e.g. genetic therapy, whether somatic cell or
germ line) and parents wish to use the process for
their child, issues may arise regarding the
enforcement of the patentee’s exclusive right
to use. Generally speaking, the patentee has the
right to prevent use unless a license is granted,
and parents would have no special immunity. However,
there would be limits to how this exclusive right
could be enforced, because of the parents’
reproductive rights. For example, a patentee could
not require a woman to have an abortion to destroy a
fetus that had been created or modified by
infringing use of a patented invention. It has been
suggested that the enforcement of such rights
against the individual parents would not be in the
patentee’s interest, as illustrated in a
hypothetical case:
If Mr. And Mrs. Thurston, learning of Medipulate
Inc.’s patented technique for germ line
manipulation, arrange with their physician for the
technique but no one pays the royalty, a damage
remedy may lie against the providers. We can
scarcely imagine a suit by Mendipulate against Mrs.
Thurston, her daughter or granddaughter, or their
physicians or hospitals, complaining of the
conception of a child, not to mention injunctive
relief, i.e., an order for an abortion. Mere
pragmatism makes clear that Mendipulate’s
interests require no remedy against a patient. Drug
manufacturers do not sue patients who infringe by
“using” an infringing drug. They sue
rival manufacturers and distributors who
“make” and “sell” it in
quantity. 78
Similarly, an individual who had, incorporated into
her body, patented biological material or material
made or inserted using a patented process would be
“using” the invention, in a sense. Even
if this were found to be “use” within
the meaning of the Patent Act, any attempt
to stop this use would probably entail an
unacceptable interference with the
individual’s autonomy and security of the
person. However, the health service provider or
manufacturer responsible for making or using the
invention would be the likely target of an
infringement action, not the individual, just as the
above analogy to drug manufacturers and patients
illustrates. Nevertheless, in certain cases an
injunction against the provider might be argued to
constitute a violation of an individual’s
rights, if the denial of access to a product
constituted a threat to the individual’s
health or bodily integrity, for example.
-
Since a human being per se cannot be owned, the
exclusive right to sell the invention would simply
have no application in the case of a patent on a
human being; the patent holder could not legally
sell the invention, nor could anyone else. Would the
exclusive right to sell other patented material
offend any constitutional rights? Sales of tissue
and of any body or body parts is prohibited by
legislation in Canada.79 However, this does not
apply to regenerative tissue such as blood or skin,
nor does it apply to human gametes.80 One author raises the
possibility of “the enterprising move of a
patient who sells gametes that contain altered
genes” that were subject to a patent.81 It is questionable
whether such a sale would fall within the rubric of
reproductive autonomy, and thus receive
constitutional protection. Likewise, an individual
probably possesses no property interest in her own
biological material,82 and even if she does,
property rights generally are not protected by
section 7. It is possible, however, that an
individual could make an argument that any such
restriction would violate her right to equality in
section 15. To the extent that individuals who were
subject to a patent or contained patented material
were restrained by law from selling biological
material when others were not, it could be argued
that this constitutes differential treatment. It
would also have to be established, however, that
this differential treatment was on an enumerated or
analogous ground, and that it was discriminatory.
-
In this section we have identified a few cases where
the grant or enforcement of a patentee’s
exclusive rights relating to human biological
material may violate the rights of individuals. If a
human being were patentable, the exclusive right to
make or use the invention could interfere with
rights to liberty and security of the person or
equality. The exclusive right to sell has no effect
regarding a sale of a human being per se but might
restrict an individual’s ability to sell
biological material. It is questionable whether the
right to sell such material would be
constitutionally protected, however.
There are a few cases in which patent rights on
subject matter which is patentable would also lead
to potential violations. First, enforcement of
patent rights relating to germ line genetic therapy
could interfere with reproductive autonomy and
equality rights. Second, enforcement of the
exclusive right to use processes relating to
reproduction or processes for intervention in an
embryo or fetus (e.g. genetic therapy) could also
interfere with reproductive rights, although in
practice this seems unlikely. Finally, where
patented biological material has been incorporated
into the body of an individual, this
individual’s section 7 rights could
potentially be affected if a patentee tried to
prevent an infringing use. Again, in practice it
seems unlikely that a patentee would pursue such a
remedy against an individual. This individual might
also be restricted from selling biological material.
There are therefore some legitimate concerns,
although many of them seem somewhat remote. It
should be emphasized, however, that the majority of
patents on human materials will not pose any direct
threat to individual rights, although they may
indirectly raise other significant human rights
concerns. Patents on biological material such as
isolated genes or proteins would not entail control
over any individual human beings in a manner which
might infringe their liberty or other rights. The
Federal Court of Appeal in the Harvard Mouse
decision stated that its comments with respect to
patents on human beings entailed “no finding
or observation on the patentability of human genes
or products or processes at the genetic level. As
scientific research advances, these and other
related matters will require determination by the
Courts or by Parliament.” 83 The European Patent
Office dealt with a claim that patents on genes and
proteins constituted slavery in the Relaxin case. As
the decision explains:
It cannot be overemphasised that patents covering
DNA encoding human H2- relaxin, or any other human
gene do not confer on their proprietors any rights
whatever to individual human beings, any more than
do patents directed to other human products such as
proteins, including human H2-relaxin. No woman is
affected in any way by the present patent –
she is free to live her life as she wishes and has
the same right of self-determination as she had
before the patent was granted. 84
In the majority of cases regarding patents on human
materials, this will be the case. If no individual
human being is directly affected by the
patentee’s exclusive rights, there may still
be other related human rights concerns (regarding
access to benefits from research, for example).
However, the grant of a patent in and of itself will
not necessarily restrict any individual’s
rights.
-
Addressing Human Rights Issues: Options for
Consideration
-
Modifying Patent Law to Protect
Individuals’ Charter Rights
One option for dealing with human rights concerns relating
to patenting of human materials is to modify patent law to
exclude certain subject matter from patentability, or to
modify the operation of rights granted to patent holders
in some cases. It is essential to remember that such
reforms are not the only measures which may be used to
protect human rights; some others will be briefly explored
below. However, with respect to the issues we discussed in
the previous section, modification of patent law may be of
particular interest as an option because there are some
cases in which the existence of a patent or the
enforcement of patent rights may constitute a direct
violation of the rights of certain individuals.
-
Judicial or
legislative modification?
A modification of patent law such as an exclusion
could occur either by legislative or by judicial
action. A challenge to provisions Patent
Act could result in a judicial modification of
patent law or its operation. The sections above
discussed several potential violations of
Charter rights. However, it would remain to
be seen in each case whether a court would actually
find that a section of the Charter had been
violated and that it could not be justified under
section 1. The analysis will be specific to each
case and thus it is not possible to make generalized
predictions about the outcome. As a result, there
will be a considerable degree of uncertainty if it
is left to the judiciary to decide whether the
operation of patent law must be modified in some
cases. This approach would also impose the burden of
bringing and arguing a Charter case on
affected individuals, and would involve substantial
delays, as opposed to the government taking a
proactive approach in legislating any changes. In
the absence of specific legislative guidance, the
Commissioner of Patents has no discretion to refuse
a patent when the requirements of the Patent
Act are satisfied.85 The courts have
jurisdiction to grant what remedies may be necessary
to protect Charter rights, but not to
undertake any further modifications for policy or
other reasons, or with the aim of preventing other
potential violations. The Federal Court of Appeal
stated in the Harvard College decision that
questions of policy and public interest should be
dealt with by Parliament.86 A declaration of
invalidity or other judicial remedy may be a blunt
instrument as compared to more detailed revisions
which may be possible by legislative action.
Finally, it is important to remember that some
subject matter will be beyond the reach of the
Charter: for example, an embryo or fetus is
not a legal person protected by the
Charter87 and there may be
questions regarding the constitutional protection of
part-human animals.88 Therefore, if we
decide that exclusions should extend to these,
legislative action would be necessary.
Addressing issues through judicial action on a
case-by-case basis has its disadvantages,89 but also allows
flexibility. It may be very difficult to design a
legislative amendment which achieves just the
desired result and anticipates all potential
problems. The complexity of this area makes it
difficult to define and predict when human rights
issues may be raised by a patent and what the best
means of protection may be. In the following
sections, we will explore some of the options and
considerations for legislative reform.
-
Exclusion from
patentability or modification of patent
rights?
The patent system could be changed to exclude
certain subject matter from patentability altogether
or to limit the scope of certain patents, or to
allow patenting but restrict the enforcement of
patent rights, either in general terms or for
specific types of patents. In order to choose
between these options, we need to precisely identify
the source of the problem. In some cases, the nature
of the patent and the rights involved may be such
that none of the patent rights should be
enforceable.90 If
that is the case it is difficult to see how a valid
patent could be granted. In other cases, however,
only a certain patent right or even a certain means
of enforcing it would be contrary to the
Charter. In such cases, it may not be
necessary or appropriate to exclude subject matter
from patentability to avoid conflict with
constitutional rights. Modifying the operation of
patent holders’ rights has the advantage of
allowing the measure to be more precisely targeted
to potential violations, leaving the patent system
otherwise intact. The modification could occur by
judicial intervention, or could be introduced by
legislative amendment, within the limits of
international trade law.91
-
Exclusion from
patentability
There may be few cases where an exclusion from
patentability is required as the only acceptable
means of protecting rights. However, exclusions may
be proposed to avoid conflicts with individual
rights or for other purposes, some of which will be
briefly discussed below.
An exclusion may take the form of a provision
excluding specific materials from patentability, or
a general provision allowing patents to be refused
on certain grounds, to be applied on a case by case
basis. Examples of specific exclusions include the
Australian Patents Act, which provides that
“[h]uman beings, and the biological processes
for their generation, are not patentable
inventions”93 and proposed
legislation in the United States which also would
have excluded human beings from patentability.93 One of the U.S.
bills also excluded human organs or parts thereof.94 Some exclusions
merely reaffirm what would be the case by the normal
operation of patent law: for example, mere
discoveries, human materials in their natural state
and human beings are not patentable because they do
not meet standard statutory criteria.
The second alternative is exemplified by the
European Patent Convention, which provides:
European patents shall not be granted in respect of:
(a) 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; 95
The more recent EU Directive incorporates
both approaches. Article 5(1) provides that
“[t]he human body, at the various stages of
its formation and development, and the simple
discovery of one of its elements, including the
sequence or partial sequence of a gene, cannot
constitute patentable inventions.” The
exclusion in article 5(1) also limits the scope of
patents, according to article 9: “The
protection conferred by a patent on a product
containing or consisting of genetic information
shall extend to all material, save as provided in
article 5(1), in which the product is incorporated
and in which the genetic information is contained
and performs its function.” Article 6 then
provides that “[i]nventions shall be
considered unpatentable where their commercial
exploitation would be contrary to ordre public or
morality” and specifies that certain
inventions will be considered unpatentable on that
basis, including processes for cloning human beings,
processes for modifying the germ line genetic
identity of human beings and uses of human embryos
for industrial or commercial purposes.
In Canadian and U.S. patent law, there is no
explicit exclusion based on ordre public or
morality, although one formerly existed in Canada.96 To a limited
extent, concerns about morality can be factored into
the analysis of whether something is a useful
invention.97 The
proposition, discussed above, that a human being
cannot be a patentable invention, can be seen as an
example of the application of such an implied
exclusion. One could conceive of a practical
industrial purpose for a human being, but it is
contrary to the legal and ethical norms of our
society to create or use a human being for such a
purpose.
Specific exclusions provide greater certainty,
although questions of interpretation will remain98
and they must be carefully designed. A general
exclusion such as “ordre public and
morality” is more flexible but therefore more
uncertain. It leaves greater discretion to the
patent office and the courts to decide when the
exclusion should apply, and some question whether
patent officials should be making such decisions.99 Depending on its
interpretation,100 the “ordre
public and morality” exception might be
adequate. It has been suggested that human rights
obligations should be the basis for interpreting
this exclusion.101 It might be advisable
to make this approach explicit in any legislative
exclusion, or to draft the exclusion to more
precisely address human rights concerns. Relying on
implied exclusions on the basis of morality as part
of the definition of an invention is the least
desirable option since it provides little clarity or
certainty, and a limited scope.
In the design of any exclusions, however, the
restrictions of international trade law in the area
of intellectual property must be taken into account.
The NAFTA and TRIPS agreements specifically permit
exclusions to protect ordre public and
morality.102 Exclusions are also allowed to protect
human or animal life, and it could be argued that
this should extend to protection of human rights, at
least security of the person. States are also
permitted to exclude plants and animals, other than
micro-organisms, and essentially biological
processes for their production.103 Otherwise, states are
required to provide patent protection in all fields
of technology.104
-
Options for Addressing Other Human
Rights Issues
This paper has focussed on cases in which the grant and
enforcement of a patent may directly violate the
Charter rights of some individual. As noted
earlier, there are many other kinds of human rights
concerns relating to the patenting of human materials.
Exclusions and other modifications of patent law have been
proposed to address some of these concerns as well.
However, the nature of these concerns may require
different options. A full exploration of these options is
beyond the scope of this paper, however this section will
outline some avenues for further consideration.
-
Earlier we discussed the possibility of excluding
certain subject matter from patentability where the
grant or enforcement of a patent could entail
violations of individual rights. Some have suggested
an even broader use of exclusions, for example to
remove the incentive for certain technologies which
society may want to discourage because of ethical or
safety concerns. However, there is no guarantee that
removing the prospect of a patent will prevent
people from developing certain types of inventions,
and removing patent protection may actually make it
more difficult to control use and commercialization
of inventions.105
Other forms of regulation may be more appropriate.
Exclusion of certain materials and processes from
patent protection has also be suggested as means of
ensuring access to essential materials for research.
If basic research tools are patented, it may be
expensive or even impossible for others to use them;
furthermore, the prospect of patents may deter the
sharing of information which allows research to
advance. This is a human rights concern because it
could lead to individuals being deprived of the
benefits of research in violation of their rights to
health and to benefit from scientific progress and
its applications.106 These concerns are
most often raised within the context of patenting
human genetic material.107
-
Other modifications
to patent law
“Compulsory licensing on basic research tools
would prevent monopolization of early-stage
technologies ... The patent holder still receives
most of the advantage from having the patent –
a commercial return – but cannot use the
patent to block further research and
development.”108
The question of access to materials and processes
for research could also be dealt with by means of a
broader research exemption, which would protect
researchers from infringement actions.109 Another alternative
is to restrict the term of a patent.110 These approaches have
the advantage of minimal interference with the
patent system, however, any such modifications of
patent law would have to take into account
international trade law on intellectual property
protection, or would require international
negotiations to the extent that they conflict with
existing law.
Another option for consideration is the integration
of protections for human rights into the patent
system. For example, the rights of research subjects
are a particular concern when we are dealing with
human materials. There are existing mechanisms in
the law and ethical guidelines to ensure that
researchers obtain the informed and voluntary
consent of individual research subjects.111 Compliance with these
standards could be required as a precondition of a
successful patent application. The EU
Directive provides in its preamble: “if
an invention is based on biological material of
human origin or if it uses such material, where a
patent application is filed, the person from whose
body the material is taken must have had an
opportunity of expressing free and informed consent
thereto, in accordance with national law.”112 As part of the
preamble, this paragraph is not legally enforceable,
but it provides a model for a provision that could
be made binding. If the practical details of such a
requirement could be worked out – what
evidence of consent is required, for instance
– there is no reason in principle why such a
proposal could not be adopted. However, these
concerns might better be dealt with through the
development of enforcement mechanisms for the rights
of research subjects, and of specific norms
regarding research leading to patented inventions.
-
Alternatives or
supplements to the patent system
Whereas the previous options would work within the
patent system, other proposals would operate as
supplements or alternatives to patenting. Richard
Gold has suggested that an alternative statutory
scheme for some human biological materials would
allow consideration of non-economic values.113 These could include a
variety of human rights issues, such as equitable
access to benefits. There have also been proposals
for similar schemes at the international level, for
example the “Human Genome Trust” which
would hold gene sequences in trust and administer a
licensing scheme instead of allowing genes to be
patented.114 Such
schemes could help to alleviate problems regarding
impediments to research and equitable distribution
of benefit. However, they contemplate exclusive
control (in the hands of a board rather than a
single corporate or individual patent holder), and
thus could potentially entail the same kinds of
intrusions into individual liberty, security and
equality as are discussed above, in certain cases.
It would be essential to integrate protection for
individual rights into any such scheme.
Concern for equitable sharing of benefits has led to
other proposals. Rules for sharing benefits with
research subjects or relevant communities could
supplement the patent system to ensure equitable
distribution of benefits.115 Others have suggested
that the “common heritage” principle be
applied to human material (in particular the human
genome) so that all human beings will benefit
equitably from genetic research.116 These could operate
as alternatives to the patent system, or as a means
of managing patent rights in certain materials.
-
Other
legislation/regulation
Some of the human rights issues identified can be
addressed through statutory or regulatory measures
independent of the patent system. As previously
discussed, there are legal and ethical rules for the
protection of research subjects, which operate
regardless of whether patentable material is at
issue but could incorporate specific standards to
deal with patenting issues. Similarly, we should
explore the application and development of legal and
ethical norms for the protection of privacy in the
context of patenting human materials.
The protection of human rights in this and other
contexts would be strengthened by the full
implementation of international human rights law
commitments in Canadian law. In particular, the area
of economic, social and cultural rights, including
the right to health and to benefit from scientific
progress, has traditionally been neglected
particularly in terms of providing judicial or other
effective remedies.117 Since these are
important areas of concern in relation to patenting
human materials, further means of implementing these
rights in Canadian law should be explored to provide
greater protection.
Finally, we could explore development of specific
legal instruments at the national and international
level to deal with the particular issues raised in
the area of patenting human materials, or a larger
set of issues in biotechnology. The UNESCO
Universal Declaration on the Human Genome and
Human Rights118 and the European
Convention on Human Rights and Biomedicine119 could be used as
models. More specific provisions relating to
patenting and human rights would need to be
developed. The Biomedicine Convention allows for the
adoption of protocols dealing with specific
topics,120 a
structure which lends itself well to complex subject
matter.
-
Conclusions and recommendations
The prospect of patenting a human being raises the most serious
human rights concerns. Human beings are likely not patentable in
any case. However, it may be advisable to exclude human beings
from patentability. Currently the Patent Office has no authority
to refuse a patent because of concerns about potential human
rights implications, and although some internal limits can be
implied in the definition of a patentable invention, this may
not offer sufficient certainty or clarity. A legislative
amendment could incorporate a text similar to the EU
Directive, which contains a general exclusion for the
protection of ordre public and morality as well as
specific exclusions, which here would include human beings.
Particular attention will need to be paid to the definition of
human beings and the scope of the exclusion. Ordre
public and morality should be interpreted to encompass the
protection of human rights; if not, then alternative wording
which specifically refers to human rights should be developed.
Alternatively, we could rely on the courts or legislative action
to prevent patentees from exercising specific patent rights that
would violate the liberty, security of the person or equality of
individuals. This latter approach may be preferable for other
types of human materials and related processes, where allowing
patenting does not necessarily entail a conflict with human
rights but the enforcement of patent rights in certain
circumstances could lead to human rights violations.
A broader range of measures will be required to address other
human rights concerns, including those relating the equitable
distribution of benefits from research and resulting patents.
Measures requiring further consideration may include
modifications to the patent system, but also the development of
other regulatory mechanisms at a national and international
level.
Index
1-40 | 41-80 | 81-120
-
1 Edward Yoo of the law firm of Bennett Jones in
Edmonton provided valuable advice and assistance on the patent law
aspects of this paper; I would like to thank Mr. Yoo and Erin
Nelson (University of Alberta Faculty of Law) for useful and
interesting discussions during the preparation of this paper, and
all those who provided comments on an earlier draft. The opinions
expressed in this paper and any remaining errors or omissions are
the author’s. This paper was written in the autumn of 2000
and revised in February 2001.
-
2 See B. vo n Tigerstrom, “Human Rights Issues
Related to the Patenting of Human Biolog cal Material,” paper
prepared for the Canadian Biotechnology Advisory Committee.
-
3 Diamond v. Chakra barty, (1980) 447 U.S. 303
(S.C.). The U.S. Patent Office had granted a patent for yeast in
1873, but later, until 1980, took the position that living matter
could not be patented. See P. A. Rae, “Patentability of
Living Subject Matter” (1993) 10 C.I.P.R. 41 at 41-42.
-
4 Re Application of Abitibi Co. (1982), 62 C.P.R. (2d)
81 (Patent Appeal Bd.).
-
5 R.S.C. 1985, c. P-4, s.2: “any new and useful
art, process, machine, manufacture or composition of matter, or any
new or useful improvement in any art, process, machine, manufacture
or composition of matter.”
-
6 Ibid., ss. 2, 28.2(1), 28.3.
-
7 President and Fellows of Harvard College v. Canada
(Commission er of Patents), [2000] F.C.J. No. 1213 (F.C.A.)
(QL) [hereinafter Harvard College]. On Oc tober 2, 2000,
the Commissioner of Patents applied for leave to appeal this
decision to the Supreme Court of Canada: Supreme Court of Canada,
Bulletin of Proceedings, 13 October 2000 at 1747.
-
8 Ibid. at para. 127.
-
9 Northern Electric Co. et al. v. Brown’s
Theatres Limited, [1939] 3 D.L.R . 729 at 749 (Ex. Ct.), a
ff’d [1941] 2 D.L.R. 105 (S.C.C.). Canadian Intellectual
Property Office, Canadian Patent Office Manual of Patent Office
Practice (Ottawa-Hull: Industry Canada, 1998), para. 16.02.01.
-
10 See H. G . Fox, Canadian Law and Practice
relating to Letters Patent for Inventions, 4th ed. (Toronto:
Carswell, 1969) at 149, 158-59.
-
11 Thanks to Ted Yoo for articulating this point. There
have been no valid patents on a fully developed human being. In
December, 1999, the European Patent Office (EPO) mistakenly granted
a patent that included within its scope a method of preparing a
transgenic human being . The application had failed to restrict the
transgenic animal to “non-human” and therefore covered
humans within its scope. European Patent Office, Press Release
1/2000, “Declaration of the European Patent Office with
regard to Patent No. EP 0695351 granted on 8 December 1999"
(22 February 2000). The patent application was subsequently amended
to exclude hum ans from its scope. There have recently been patents
granted for human embryos, however: see infra note 87.
-
12 Fox, supra note 10 at 156-57; see also infra
note 97 an d accom panying text.
-
13 This is important given that there are many
misconceptions among members of the public regarding the concept of
patents on human beings or other human materials. For example, it
is not unusual to see references to “patents on humans”
or “patents on people” when what is really meant is
gene patents, and according to recent news reports, a British woman
applied for a patent on herself in order to protect her genetic
material. Her application stated: “It has taken 30 years of
hard labour for me to discover and invent myself, and now I wish to
protect my invention from unauthorised exploitation , genetic or
otherwise.” See James Meek, “Poet attempts the ultimate
in self-invention - patenting her own genes,” 29 February
2000, The Guardian, online: (
http://www.guardianunlimited.co.uk/Archive/Article/0,4273,3968738,00.html).
-
14 D. J. Quigg (Commissioner of the United States Patent
and Trademark Office), Statement, “Policy Statement on
Patentability of Animals,” 1077 Off. Gaz. Pat. Office 24 (7
April 1987).
-
15 Harvard College, supra note 7 at
paras. 125-28.
-
16 K. D. DeBré, “Patents on People and the
U.S. Constitution: Creating Slaves or Enslaving Science?”
(1989) 16 Hastings Const’l L. Q. 221 at 228; R. E. Fishman,
“Patenting Human Beings: Do Sub-Human Creatures Deserve
Constitutional Protection?” (1989) 15 Am. J. L. & Med.
461 at 462.
-
17 Fishman, ibid., at 462; DeBré,
ibid., at 258; D. L. Burk, “Patenting Transgenic
Human Embryos: A Nonuse Cost Perspective” (1993) 30 Houston
L. Rev. 1597 at 1647; R. Walker, “Patent Law – Sho uld
Genetically Engineered Human Beings Be Patentable?” (1991) 22
Memphis State U. L. Rev. 101 at 111.
-
18 Burk, ibid. at 1647-48.
-
19 Walker, supra note 17 at 1 11; DeBré,
supra note 16 at 258.
-
20 Burk, supra note 17 at 1648; Fishman,
supra note 16 at 474-75; DeBré, supra note
16 at 231-32.
-
21 Universal Declaration of Human Rights, 10
December 1948 , UN G.A. Res. 3/217A [hereinafter UDHR], article 4;
International Covenant on Civil and Political Rights, 16
December 1966, Can. T.S. 1976 No. 47, 999 U.N.T.S. 171 [he
reinafter ICC PR], article 8; Slavery Convention, 25
September 1926, 60 L.N.T.S. 253; Convention for the Suppression
of the Traffic in Persons and of the Exploitation of the
Prostitution of Others, 21 March 1950, 96 U.N.T.S. 271;
Supplementary Convention on the Abolition of Slavery, the Slave
Trade, and Institutions and Practices Similar to Slavery, 7
September 1956, 226 U.N.T.S.3. Canada is a party to all of these
except the Convention for the Suppression of the Traffic in
Persons and of the Exploitation of the Prostitution of Others.
-
22 Slavery Convention, ibid., article
1(1) (emphasis added).
-
23 B. Ziff, Principles of Property Law, 2nd ed.
(Scarborough, Ontario: Carswell, 1996) at 2.
-
24 Ibid. at 5.
-
25 Section 1 provides that rights are guaranteed
“subject only to such limits prescribed by law as can be
demonstrably justified in a free and democratic society.” The
test for justification under s. 1 has been stated as follows:
“First, the objective of the legislation must be pressing and
substantial. Second, the means chosen to attain this legislative
end must be reasonable and demonstrably justifiable in a free and
democratic society. In order to satisfy the second requirement,
three criteria must be satisfied: (1) the rights violation must be
rationally connected to the aim of the legislation; (2) the
impugned provision must minimally impair the Charter guarantee; and
(3) there must be a proportionality between the effect of the
measure and its objective so that the attainment of the legislative
goal is not outweighed by the abridge ment of the right. In all s.
1 cases the burden of proof is with the government to show on a
balance of probabilities that the violation is justifiable.”
Egan v. Canada, [1995] 2 S.C.R. 513 at para. 182.
-
26 R. v. Beare, [1988] 2 S.C.R. 387;
Thomson Newspapers v. Canada, [1990] 1 S.C.R. 425.
-
27 Blencoe v. British Columbia (Human Rights
Commission), 2000 SCC 44 [hereinafter Blencoe] at
para. 49-52; Godbout v. Longueuil, [1997] 3 S.C.R. 8 44 at
para . 66. See also e.g. Singh v. Minister of Employment and
Immigration, [1985] 1 S.C.R. 177 at 20 5; R. v.
Morgentaler (No. 2), [1988] 1 S.C.R. 30 at 164-66
[hereinafter Morgentaler]; B. (R.) v. Children’s
Aid Society of Metropolitan Toronto, [1995] 1 S.C.R. 315 at
para. 83.
-
28 Blencoe, ibid. at para. 51.
-
29 Godbout v. Longueuil, supra note 27.
-
30 Fleming v. Reid (1991), 4 O.R. (3d) 74 (Ont.
C.A.) at 88. According to the majority in B.(R.), supra
note 27, it may also include the right to make medical decisions
for one’s child.
-
31 Morgentaler, supra note 27, E. v.
Eve, [1986] 2 S.C.R. 388.
-
32 Blencoe, supra note 27 at para. 54. See also
B.(R.), supra note 27 at para. 80, citing Re B.C.
Motor Vehicle Act, [1985] 2 S.C.R. 486 at 524; R. v.
Edwards Books and Art Ltd., [1986] 2 S.C.R. 713 at 785-86.
-
33 Edwards Books, ibid., Re ss. 193 and 195.1 of the
Criminal Code, [1990] 1 S.C.R. 1123, ILWU v. Canada,
[1994] 1 S.C.R. 150.
-
34 Re ss. 193 and 195.1 of the Criminal Code,
ibid.
-
35 Morgentaler, supra note 27; Rodriguez v.
British Columbia (Attorney General) , [1993] 3 S.C.R. 519;
Fleming v. Reid, supra note 30.
-
36 Morgentaler, supra note 27.
-
37 P. W. Hogg, Constitutional Law of Canada,
Loose-leaf ed., (Scarborough: Carswell, 1997) at 44-10.
-
38 Morgentaler, supra note 27 at 5 6, 173;
Re ss. 193 and 195.1 of the Criminal Code, supra note 33
at 1177; Rodriguez, supra note 35 at 5 87-88; Mills v. The
Queen, [1986] 1 S.C.R. 8 63; New Brunswick (Minister of
Health and Community Services) v. G.(J.), [1999] 3 S.C.R. 46
[hereinafter G.(J.)] at paras. 58 -60; Blencoe, supra note
27 at para. 55-57.
-
39 G.(J.), ibid. at para. 60.
-
40 G.(J.), supra note 38 at 6 1-62; Mills
v. The Queen, supra note 38 at 919-20; R. v. Mills,
[1999] 3 S.C.R. 668 at para. 85.
-
41 See e.g. G .-A. Beaudoin & E. Mendes, The
Canadian Charter of Rights and Freedoms, 3rd ed. (Toronto:
Carswell, 19 95) at 9-1 7 - 9-18, Hogg, supra note 37 at
44-11 - 44-13 and cases cited therein.
-
42 Blencoe, supra note 27 at para. 74-80.
-
43 Re B.C. Motor Vehicles Act, supra note 32 at
503.
-
44 Morgentaler, supra note 27.
-
45 E.g. Rodriguez, supra note 35.
-
46 E.g. Re ss. 193 and 195.1 of the Criminal Code,
supra note 33.
-
47 R. v. Heywood, [1994] 3 S.C.R. 761.
-
48 Supra note 35.
-
49 B.(R.) v. Children’s Aid Society of
Metropolitan Toronto, [1995] 1 S.C.R. 315.
-
50 See e.g. Cunningham v. Canada, [1993] 2
S.C.R. 143 at 152.
-
51 Law v. Canada (Minister of Employment and
Immigration), [1999] 1 S.C.R. 497 at para. 88.
-
52 However, since the major focus of this paper, in
accordance with its terms of reference, is on section 7, further
exploration of the equality issues raised in this context maybe
required.
-
53 Canadian Charter of Rights and Freedoms,
Part I of the Constitution Act, 1982, being Schedule B to
the Canada Act 1982 (U.K.), 1982, c. 11, section 32(1)(a).
-
54 Constitution Act, 1982, being Schedule B to
the Canada Act 1982 (U.K.), 1982, c. 11, section 52 (1).
-
55 Although this would be a private action between two
private parties, the patentee would be relying on the Patent
Act in seeking a remedy against an alleged infringer; this
situation is therefore distinguishable from the case of RWDSU
v. Dolphin Delivery Ltd., [1986] 2 S.C.R. 573, where the party
seeking an injunction was relying only on the common law. A court
order in itself is not sufficient government action to attract the
application of the Charter (ibid. at para. 36),
but where the exercise of government action such as legislation is
present and relied upon by one of the parties to produce an
infringement of the rights of another, the Charter will
apply (ibid. at para. 37-39).
-
56 Patent Act, supra note 5, s. 42.
-
57 Fox, supra note 10 at 349.
-
58 Ibid. at 381-82.
-
59 The Patent Act, supra note 5, s. 55.2(6)
states that its provisions do not “affect any exception to
the exclusive property or privilege granted by a patent that exists
at law in respect of acts done privately and on a non-commercial
scale or for a non-commercial purpose”; however the scope of
this exception is not clear. Fox, supra note 10 at 382
states that making a patented article even for private use is an
infringement, and a patent is infringed even if the infringer gains
no benefit, commercial or otherwise, from the article. Of course
these factors may affect the remedies available to the patentee,
however.
-
60 Ibid., s. 55.
-
61 Ibid., s. 57.
-
62 L. M. Guenin, “Norms for Patents Concerning
Human and Other Life Forms” (1996) 17 Theoretical Medicine
279 at 281. In the Harvard mouse case, Rothstein J. stated:
“One might argue this simply involves the natural processes
of mouse reproduction. However, such a view ignores the fact that
an offspring oncomouse has the artificial oncogene sequence by
virtue of its introduction into the genome of the original founder
mouse. The offspring oncomouse has a particular genetic trait which
would not occur in nature.” Harvard College, supra
note 7 at para. 42.
-
63 Harvard College, supra note 7 at para. 93,
citing W. Hayhurst, “Exclusive Rights in Relation to Living
Things” (1991) 6 Intellectual Property Journal 171 at 177.
-
64 Morgentaler, supra note 27, E. v. Eve,
supra note 31.
-
65 See Walker, supra note 17 at 110-11; Burk,
supra note 17 at 1649-50 ; Fishman, supra note 16
at 475; DeBré, supra note 16 at 238.
-
66 Guenin, supra note 62 at 281.
-
67 Some commentators have argued that the likelihood of
such a conflict actually occurring is small, since in most cases
the term of the patent would have expired before any affected
individuals reached reproductive maturity: DeBré,
supra note 16 at 238, n.98; Burk, supra note 17
at 1 649; Walker, supra note 17 at 111. However, this is
not necessarily the case. The twenty-year term of a patent allows
the possibility of natural human reproduction occurring within the
term, not to mention any artificial means which might not rely on
reproductive maturity.
-
68 Fishman, supra note 16 at 475-76.
-
69 Walker, supra note 17 at 111.
-
70 For example, it has not been interpreted to cover
personal relationships such as associations between family members:
Catholic Children’s Aid Society of Metropolitan Toronto
v. S.(T.) (1989), 60 D.L.R. (4th) 397 (Ont. C.A.); or
restrictions on trade: Canadian Egg Marketing Agency v.
Richardson, [1998] 3 S.C.R. 157.
-
71 Regarding consent generally, see E. Nelson,
“The Fundamentals of Consent” in J. Downie & T.
Caulfield, Canadian Health Law and Policy (Toronto:
Butterworths, 1999) 101; regarding consent for research see K. C.
Glass, “Research Involving Humans” in Downie &
Caulfield, ibid., 375 at 38 1ff.
-
72 See e.g. World Medical Association,
“Declaration of Helsinki: Recommendations Guiding Physicians
in Biomedical Research Involving Human Subjects,” June 1964,
18th World Medical Assembly, online: (http://www.wma.net/e/policy/);
Medical Research Council of Canada, Natural Sciences and
Engineering Research Council of Canada & Social Sciences and
Humanities Research Council of Canada , Tri-Council Policy
Statement: Ethical Conduct for Research Involving Humans (Ottawa:
Public Works and Government Services Canada, 19 98), online: (http://www.nserc.ca/programs/ethics.htm).
-
73 See e.g. ICCPR, supra note 21, article 7;
Convention for the Protection of Human Rights and Dignity of
the Human Being with Regard to the Application of Biology and
Medicine: Convention on Human Rights and Biomedicine, 4 April
1997, E.T .S. No. 164, articles 5, 16 (the latter is a regional
convention to which Canada is nota party).
-
74 Fleming v. Reid, supra note 30.
-
75 E.g. ICCPR, supra note 21, article 17.
-
76 See e.g. R. v. Plant, [1993] 3 S.C.R. 281; R. v.
Dyment, [1988] 2 S.C.R. 417; R. v. O’Connor,
[1995] 4 S.C.R. 411; R. v. Mills, [1999] 3 S.C.R. 668. For
discussions of the protection of privacy under the Charter
see M. Marshall & B. von Tigerstrom, “Privacy,
Confidentiality and the Regulation of Health Information” in
Canadian Health Law Practice Manual (Toronto:
Butterworths, 2000); B. von Tigerstrom , P. Nugent & V. Cosco,
“Alberta’s Health Information Act and the
Charter: A Discussion Paper” Health Law Review
(forthcoming).
-
77 See supra note 70.
-
78 Guenin, supra note 62 at 304.
-
79 See e.g. Human Tissue Gift Act, R.S.A. 1980,
c. H-12, s. 10: “No person shall buy, sell or otherwise deal
in , directly or indirectly, for a valuable consideration, any
tissue for a transplant, or anybody or part or parts of it other
than blood or a blood constituent, for therapeutic purposes,
medical education or scientific research, and any such dealing is
invalid as being contrary to public policy.” See also e.g .:
Human Tissue Gift Act, R.S.B.C. 1996, c. 211, s.10 ;
Human Tissue Act, R.S.M. 1987, c. H 180, s. 15 (2);
Human Tissue Gift Act, R.S.O. 1990, c. H-20 (to be renamed
Trillium Gift of Life Network Act: S.O. 2000, c. 39), s.
10 , Human Tissue Act, R.S.N.B. 1973, c. H-12, s. 8(3);
Human Tissue Gift Act, R.S.N.S. 1989, c. 215, s. 11;
Human Tissue Act, R.S.N. 1990, c. H-1 5, s. 18; Human
Tissue Gift Act, R.S.Y. 1986, c. 89, s. 10.
-
80 See M. Litman & G. Robertson, “The Common
Law Status of Genetic Material” in B. M. Knoppers, T.
Caulfield & T. D. K insella, Legal Rights and Human Genetic
Material (Emond Montgomery, 1996) 51 at 53.
-
81 Guenin, supra note 62 at 305.
-
82 Moore v. Regents of the University of
California, 249 Cal. Rptr. 494, rev’d in part 271 Cal.
Rptr. 146 (1990), cert. denied 111 S.Ct. 1388 (1991).
-
83 Harvard College, supra note 7 at paras.
125-28.
-
84 Howard Florey / Relaxin, [1995] EPOR 541 at
para. 6.3.3. See also Directive on the legal protection of
biotechnological inventions, Directive 98/44/EC, O.J. L 213,
30/07/1998 p. 001 3-0021, [hereinafter EU Directive]
preamble para. 20: “an invention based on an element isolated
from the human body or otherwise produced by means of a technical
process, which is susceptible of industrial application, is not
excluded from patentability, even where the structure of that
element is identical to that of a natural element, given that the
rights conferred by the patent do not extend to the human body and
its elements in their natural environment.”
-
85 See Harvard College, supra note 7 at para.
29.
-
86 Ibid. at paras. 30, 92, 117-18.
-
87 Tremblay v. Daigle, [1989] 2 S.C.R. 530;
Winnipeg Child and Family Services (Northwest Area) v. G.
(D.F.), [1997] 3 S.C.R. 925. In early 2000, the first patent
to include within its scope a cloned human embryo was granted by
the British patent office. Geron Corporation received patents in
January and February, 2000 relating to nuclear transfer methods and
products, including human embryos at an early stage of development.
Patent No. GB2318578, “Quiescent cell Populations for Nuclear
Transfer,” issued 19 January 2000; Patent No. GB2331751,
“Quiescent cell populations for nuclear transfer,”
issued 19 January 2000; Patent No. GB2318792, “Unactivated
oocytes as cytoblast recipients for nuclear transfer,” issued
23 February 2000; Patent No. GB2340493, “Unactivated oocytes
as cytoblast recipients for nuclear transfer,” issued 23
February 2000. See Geron Corporation, “Geron Announces
Granting of Nuclear Transfer Patents,” News Release, 21 June
2000, online: (www.geron.com).
-
88 See e.g. Fishman, supra note 16; von
Tigerstrom, supra note 2 at 19-20. On the question of
defining human beings for the purposes of patent law and a
legislative exclusion, see also T. Schrecker et al.,
“Ethical Issues Associated with the Patenting of Higher Life
Forms” (17 May 1997) online: (
http://strategis.ic.gc.ca/epic/site/ippd-dppi.nsf/en/ip00095e.html).
-
89 See also B M. Knoppers, “Reflections: The
Challenge of Biotechnology and Public Policy” (2000) 45
McGill L. J. 559 at 564: a “constitutional” approach to
policy development “is both costly and lengthy; furthermore
it is ad hoc in nature.”
-
90 For example in the case of patents on human beings:
see Fishman, supra note 16 at 476; Burk, supra
note 17 at 1650; Walker, supra note 17 at 110.
-
91 Both the NAFTA and TRIPS require patent protection to include
exclusive rights to make, use, offer for sale or sell a patent
product or product obtained directly from a patented process.
North American Free Trade Agreement Between the Government of
Canada, the Government of Mexico and the Government of the United
States, 17 December 1992, Can. T.S. 1994 No.2, 32 I.L.M . 289
[hereinafter NAFTA], article 1709 (5); Final Act Embodying the
Results of the Uruguay Round of the Multilateral Negotiations,
Marrakesh Agreement Establishing the World Trade Organization,
signed at Marrakesh (Morocco), April 15, 1994, Annex 1C, Agreement
on Trade- Related Aspects of Intellectual Property Rights,
GATT, Doc.MTN/FA/Add.1 (15 December 1993); reprinted in 33 I.L.M.
1197, 1200 [hereinafter TRIPS], article 28. They also restrict the
issuance of compulsory licenses and require certain remedies to be
available to the patentee. See C. Kent, “The Uruguay
Round GATT TRIPS Agreement and Chapter 17 of the NAFTA: A New
Era in International Patent Protection” (1993) 10 C.I.P.R.
711 at 723-25.
-
92 Patents Act 1990 (Australia), s. 18.2.
-
93 Life Patenting Moratorium Act of 1993,
S.387, 103d Congress, 1st Session, s.3; Transgenic Animal
Patent Reform Act, H.R. 1556, 101st Congress, 1st Session,
s.4; Patent Competitiveness and Technological Innovation
Act of 1990, H.R. 5598, 101st Congress, 2nd Session, s.204.
-
94 Life Patenting Moratorium Act of 1993, ibid.
-
95 European Patent Convention, 5 October 1973,
U.K.T.S. 1978 No.20, article 53(a). This article was recently
amended to read: “inventions the commercial exploitation of
which would be contrary to "ordre public" or morality,
provided that such 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.” Act Revising the
Convention on the Grant of European Patents, 29 November 2000,
article 18.
-
96 The former section 27(3) of the Patent Act
excluded inventions for “illicit” objects (repealed by
the new s.27(8) in S.C. 1993, c.15, s.31).
-
97 See Ex parte Murphy, 200 U.S.P.Q. 801 (PTO
Bd. App. 1977), cited in J.-C. Galloux, “La
brevabilité du génome humain ou la tension entre le
droit des biotechnologies et les bio-droits” in J.-L.
Baudouin & S. Le Bris, Droits de la
personne: “Les bio-droits” Aspects
nord-américains et européens
(Cowansville, Quebec: Yvon Blais, 1997) 309 at 32 2; see also B.
Looney, “Should Genes be Patented? The Gene Patenting
Controversy: Legal, Ethical, and Policy Foundations of an
International Agreement” (1994) 26 J. L. Pol’y
Int’l Business 231 at 251.
-
98 For example, where a “human being” is
excluded, it must be determined what this should include. See e.g.
IP Australia, Australian Patent Office Manual of Practice and
Procedure (IP Australia, 1999), online: (http://www.ipaustralia.gov.au/patents/Manual),
at para. 8.5.1. See also the sources cited supra note 75
regarding the definition of human beings.
-
99 B. Yorke, “Which Rules of Patenting are
Acceptable from the Point of View of Industry?” in F. Vogel
& R. Grunwald, eds., Patenting of Human Genes and Living
Organisms (Berlin: Springer, 1994) 197 at 197-98 .
-
100 The interpretation of this exception in the Europe
an context is not settled: Galloux, supra note 97 at 323.
It has been used as the basis for a broad
“cost-benefit” analysis: see Harvard /
Onco-mouse, [1990] EPOR 4, at para. 5; another view,
exemplified in the Relaxin decision, suggests that it
should only be applied in “rare and extreme cases”
where the invention “would universally be regarded as
outrageous” : Howard Florey / Relaxin, supra note 84
at para. 6.2.1. See also F.-K. Beier & R. Moufang,
“Patentability of Human Genes and Living Organisms:
Principles of a Possible International Understanding” in
Vogel & Grunwald, ibid., 205 at 214.
-
101 R. Ford, “The Morality of Biotech Patents:
Differing Legal Obligations in Europe?” (1997) 6 E.I.P.R.
315.
-
102 NAFTA, supra note 91, ar ticle 1709 (2);
TRIPS, supra note 91, article 27(2).
-
103 NAFTA, supra note 91, ar ticle 1709 (3);
TRIPS, supra note 91, article 27(3).
-
104 NAFTA, supra note 91, ar ticle 1709 (1);
TRIPS, supra note 91, article 27(1).
-
105 E. R. Gold, “Biomedical Patents and Ethics: A
Canadian Solution” (2000) 45 McGill L. J. 413 at 420.
-
106 International Covenant on Economic, Social and
Cultural Rights, 16 December 1966, Can. T.S. 1976 No. 46 , 993
U .N.T.S. 3 [hereinafter ICESCR], articles 12, 15(1)(b). UDHR,
supra note 21, articles 25(1), 27(2). For a discussion of
these issues, see von Tigerstrom, supra note 2 at 9-11 and
the sources cited therein.
-
107 There has been a great deal of writing on this
subject which will not be reviewed in detail here. See e.g. Looney,
supra note 97 at 243-46; M. A. Heller & R. S.
Eisenberg, “Can Patents Deter Innovation? The Anticomons in
Biomedical Research” (1998) 280 Science 6 98; E. R. Gold,
“Making Room: Reintegrating Basic Research, Health Policy,
and Ethics into Patent Law” in T. Caulfield & B.
Williams-Jones, eds., The Commercialization of Genetic
Research: Ethical, Legal, and Policy Issues (New York: Kluwer
Academic/Plenum, 1999) 63 at 65-66 [hereinafter “Making
Room”]; D. Keays, “Patenting DNA and Amino Acid
Sequences – An Australian Perspective” (1999) 7 Health
L. J. 69 at 73-74. The Human Genome Organization has made a number
of statements regarding these concerns, including “HUGO
Statement on the Patenting of DNA Sequences,” January 1995,
online: (http://www.gene.ucl.ac.uk/hugo/patent);
and more recently “HUGO Statement on the Patenting of DNA
sequences: In Particular Response to the European Biotechnology
Directive,” April 2000, online: (http://www.gene.ucl.ac.uk/hugo/patent2000.html),
focussing on expressed sequence tags (ESTs).
-
108 “Making Room,” ibid. at 72.
-
109 There is an exemption for experimental use at common
law , but it traditionally covered only experiments for purely
“philosophical” motives or for amusement, and with no
commercial purpose. The Patent Act does not create any
exemption for research but the common law exemption is preserved by
s.55.2(6): “For greater certainty, subsection (1) does not
affect any exception to the exclusive property or privilege granted
by a patent that exists at law... in respect of any use,
manufacture, construction or sale of the patented invention solely
for the purpose of experiments that relate to the subject-matter of
the patent.” For discussions of the scope of the exemption,
see “Making Room ”, ibid. at 71; L. M . Kurdydyk &
S. S. McDiarmid , “Patent Infringe ment Issues Relating to
Biotechn ology” (1993) 10 C .I.P.R. 175 at 179-88; I. P.
Cooper, Biotechnology and the Law (St. Paul, Minnesota:
West Group, 1982, revised 1999), vol.1 at §5A.12; Micro
Chemicals Ltd. v. Smith Kline & French Laboratories Ltd.,
[1972] S.C.R. 506.
-
110 “Making Room,” ibid. at 72.
-
111 See supra notes 71-74 and accompanying
text.
-
112 Supra note 84, preamble, para. 26.
-
113 “Making Room,” supra note 107
at 75-76. For a further discussion and assessment of this proposal,
see “Biomedical Patents and Ethics: A Canadian
Solution,” supra note 105 at 421-26.
-
114 Looney, supra note 97 at 269-71; see also
Keays, supra note 107 at 87.
-
115 See HUGO Ethics Committee, “Statement on
Benefit-Sharing,” 9 April 2000, online: (http://www.gene.ucl.ac.uk/hugo/benefit.html);
B. M. Knoppers, “Status, sale and patenting of human genetic
material: an international survey” (1999) 22 Nature Genetics
23 at 24.
-
116 B. M. Knoppers, Human Dignity and Genetic
Heritage (Ottawa: Law Reform Commission of Canada, 1991) at
18-20; B. M. Knoppers, “Sovereignty and Sharing” in
Caulfield & Williams-Jones, supra note 107, 1 at 3,
9-10; Keays, supra note 107 at 88.
-
117 States parties to the ICES CR undertake to take
steps “by all appropriate means, including particularly the
adoption of legislative means” to achieve the realization of
the rights in the Covenant (supra note 106, article 2(1)).
A variety of effective measures may be required , but the provision
of judicial or other effective remedies is considered essential:
see e.g. Committee on Economic, Social and Cultural Rights,
CESCR General Comment 9: The domestic application of the
Covenant, 19th Sess. (1998), UN Doc. E/C.12/1998/24 at paras.
2, 3, 9; Committee on Economic, Social and Cultural Rights,
CESCR General Comment 14: The right to the highest attainable
standard of health , 22nd Sess., UN Doc. E /C.12/2000/4 (20
00) at para. 59; The Limburg Principles on the Implementation
of the Internatio nal Covenant on Economic, Social and Cultural
Rights, UN Doc. E/CN .4/1987 /17, Annex, reprinted in (1987) 9
Hum. Rts. Q. 122 at para. 19. The Committee on Economic, Social and
Cultural Rights has urged the Government of Canada to take steps to
ensure that Covenant rights are enforceable: Committee on Economic,
Social and Cultural Rights, Concluding Observations of the
Committee on Economic, Social and Cultural Rights: Canada,
19th Sess., UN Doc. E/C.12/1/Add.31, para. 52.
-
118 Universal Declaration on the Human Genome and
Human Rights, UNESCO Gen. Conf., 29th Sess., 29 C/Resolution
19 (1997).
-
119 Supra note 73. This Convention does not
deal specifically with patenting, although it contains a general
provision in article 21 stating that “[t]he human body and
its parts shall not, as such, give rise to financial gain.”
It is an example of an attempt to deal with human rights issues in
the context of medical treatment and research in a specific
regional instrument.
-
120 The first, dealing with human cloning, was concluded
in 1998: Additional Protocol to the Convention for the
Protection of Human Rights and Dignity of the Human Being with
regard to the Application of Biology and Medicine, on the
Prohibition of Cloning Human Beings, 12 January 1998, E.T.S.
No. 168.
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