Harvard College v.
Canada (Commissioner of Patents)
2002: December 5
Commissioner of Patents
Respondent
President and Fellows of Harvard College
Appellant
Canadian Council of Churches,
Evangelical Fellowship of Canada, Canadian Environmental Law Association,
Greenpeace Canada, Canadian Association of Physicians for the Environment,
Action Group on Erosion, Technology and Concentration, Canadian Institute
for Environmental Law and Policy, Sierra Club of Canada, Animal Alliance
of Canada, International Fund for Animal Welfare Inc. and Zoocheck Canada
Inc.
Interveners
Indexed as: Harvard College v. Canada
(Commissioner of Patents)
Neutral citation: 2002 SCC 76.
File No.: 28155
2002: May 21; 2002: December 5
Present: McLachlin C.J. and L'Heureux-Dubé,
Gonthier, Iacobucci, Major, Bastarache, Binnie, Arbour and LeBel JJ.
ON APPEAL FROM THE FEDERAL COURT OF APPEAL
Patents --
Patentable subject matter -- Standard of review -- Standard of review applicable
to Commissioner of Patent's decision to refuse patent.
Patents --
Patentable subject matter -- Biotechnology -- Patentability of higher life forms
-- College seeking to patent genetically altered mouse for cancer research --
Whether "invention" encompasses higher life forms -- Meaning of "manufacture"
and "composition of matter" -- Patent Act, R.S.C. 1985, c. P-4, s. 2
"invention".
The respondent applied for a patent on an
invention entitled "transgenic animals". According to the application, a
cancer-promoting gene ("oncogene") is injected into fertilized mouse eggs as
close as possible to the one-cell stage. The eggs are then implanted into a
female host mouse and permitted to develop to term. After the offspring of the
host mouse are delivered, they are tested for the presence of the oncogene.
Those that contain the oncogene are called "founder" mice. Founder mice are
mated with mice that have not been genetically altered. Fifty per cent of the
offspring will have all of their cells affected by the oncogene, making them
suitable for animal carcinogenic studies. In its patent application, the
respondent seeks to protect both the process by which the oncomice are produced
and the end product of the process, i.e. the founder mice and the offspring
whose cells contain the oncogene. The process and product claims extend to all
non-human mammals. The process claims were allowed by the Patent Examiner, while
the product claims were rejected. The appellant Commissioner confirmed the
refusal of the product claims. The Federal Court, Trial Division, dismissed the
respondent's appeal from the appellant's decision. The respondent's further
appeal to the Federal Court of Appeal was allowed.
Held (McLachlin C.J. and Major,
Binnie and Arbour JJ. dissenting): The appeal should be allowed. A higher life
form is not patentable because it is not a "manufacture" or "composition of
matter" within the meaning of "invention" in s. 2 of the Patent Act.
Per L'Heureux-Dubé, Gonthier,
Iacobucci, Bastarache and LeBel JJ.: This appeal raises the issue of the
patentability of higher life forms within the context of the Patent Act.
A. The
Commissioner's power to refuse a patent under s. 40
The standard of review applicable to the
Commissioner's decision in this case is correctness. The courts are as well
placed as the Commissioner to decide whether the definition of invention in s. 2
of the Patent Act encompasses higher life forms, since the Patent Act
contains no privative clause, gives applicants a broad right of appeal, and
the question approaches a pure determination of law that has significant
precedential value. Section 40 of the Patent Act does not give the
Commissioner discretion to refuse a patent on the basis of public policy
considerations independent of any express provision in the Act. Since the
Commissioner has no discretion independent of the Patent Act to consider
the public interest when granting or denying a patent, the Commissioner's
decision in this case, given its nature, is not owed deference.
B. The
Definition of Invention: whether a higher life form is a "manufacture" or a
"composition of matter"
The sole question in this appeal is
whether the words "manufacture" and "composition of matter", within the context
of the Patent Act, are sufficiently broad to include higher life forms.
It is irrelevant whether this Court believes that higher life forms such as the
oncomouse ought to be patentable. The words of the Patent Act "are to be
read in their entire context and in their grammatical and ordinary sense
harmoniously with the scheme of the Act, the object of the Act, and the
intention of Parliament". Comparisons with the patenting schemes of other
countries will therefore be of limited value. The best reading of the words of
the Act supports the conclusion that higher life forms are not patentable.
(1) The Words of the Act
For a higher life form to fit within the
definition of "invention", it must be considered to be either a "manufacture" or
a "composition of matter". While the definition of "invention" in the Patent
Act is broad, Parliament did not define "invention" as "anything new and
useful made by man". The choice of an exhaustive definition signals a clear
intention to exclude certain subject matter as being outside the confines of the
Act. The word "manufacture" ("fabrication"), in the context of the Act,
is commonly understood to denote a non-living mechanistic product or process,
not a higher life form. The words "composition of matter" ("composition de
matière") as they are used in the Act do not include a higher life form such
as the oncomouse. The words occur in the phrase "art, process, machine,
manufacture or composition of matter". A collective term that completes an
enumeration is often restricted to the same genus as the terms which precede it,
even though the collective term may ordinarily have a much broader meaning. Just
as "machine" and "manufacture" do not imply a living creature, the words
"composition of matter" are best read as not including higher life forms. While
a fertilized egg injected with an oncogene may be a mixture of various
ingredients, the body of a mouse does not consist of ingredients or substances
that have been combined or mixed together by a person. Moreover, "matter"
captures only one aspect of a higher life form, generally regarded as possessing
qualities and characteristics that transcend the particular genetic material of
which it is composed. Higher life forms cannot be conceptualized as mere
"compositions of matter" within the context of the Patent Act. Just
because all inventions are unanticipated and unforeseeable, it does not
necessarily follow that they are all patentable. It is possible that Parliament
did not intend to include higher life forms in the definition of "invention". It
is also possible that Parliament did not regard cross-bred plants and animals as
patentable because they are better regarded as "discoveries". Since patenting
higher life forms would involve a radical departure from the traditional patent
regime, and since the patentability of such life forms is a highly contentious
matter that raises a number of extremely complex issues, clear and unequivocal
legislation is required for higher life forms to be patentable. The current Act
does not clearly indicate that higher life forms are patentable.
(2) The Scheme of the Act
The above interpretation of the words of
the Act finds support in the fact that the patenting of higher life forms raises
unique concerns which do not arise in respect of non-living inventions and which
are not addressed by the scheme of the Act. The fact that the Act is
ill-equipped to deal appropriately with higher life forms as patentable subject
matter is an indication that Parliament never intended the definition of
invention to extend to this type of subject matter. While some policy concerns,
such as the environmental and animal welfare implications of biotechnology, are
more appropriately dealt with outside the patent system, other concerns are more
directly related to patentability and to the scheme of the Act. These concerns
illustrate the fact that the Patent Act in its current form is not well
suited to address the unique characteristics possessed by higher life forms. The
issue of the patenting of human life forms is a complex one that cannot be
readily dismissed by reference to the Charter. It is not an appropriate
judicial function of the courts to create an exception from patentability for
human life given that such an exception requires one to consider both what is
human and which aspects of human life should be excluded. The lack of direction
currently in the Act to deal with issues that might reasonably arise signals a
legislative intent that higher life forms are currently not patentable. This
Court does not possess the institutional competence to deal with issues of this
complexity, which presumably will require Parliament to engage in public debate,
a balancing of competing social interests, and intricate legislative drafting.
(3) The Object of the Act
Although the Patent Act is
designed to advance research and development and encourage broader economic
activity, it simply does not follow from the objective of promoting ingenuity
that all inventions must be patentable. A product of human ingenuity must fall
within the terms of the Act in order for it to be patentable; the issue of
whether a proposed invention ought to be patentable does not provide an answer
to the question of whether that proposed invention is patentable. In any event,
the manner in which Canada has administered its patent regime reveals that the
promotion of ingenuity has at times been balanced against other considerations.
(4) Related Legislation: The
Plant Breeders' Rights Act
The interpretation of an ambiguous law
may be informed by the substance and the form of subsequent legislation. The
Plant Breeders' Rights Act is of significance to the interpretation of the
Patent Act and the issue of its applicabiilty to higher life forms.
Although Parliament enacted special legislation for the protection of plant
breeders, it did not address other higher life forms. Moreover, the passage of
the Plant Breeders' Rights Act demonstrates that mechanisms other than
the Patent Act may be used to encourage inventors to undertake innovative
activity in the field of biotechnology. Many of the issues that arose with
respect to intellectual property protection for plant varieties also arise when
considering the patentability of other higher life forms. If a special
legislative scheme was needed to protect plant varieties, a subset of higher
life forms, a similar scheme may also be necessary to deal with the patenting of
higher life forms in general. It is beyond the competence of this Court to
address in a comprehensive fashion the issues associated with the patentability
of higher life forms.
C. Drawing the
line: Is it defensible to allow patents on lower life forms while denying
patents on higher life forms?
The patentability of lower life forms is
not at issue before this Court, and was in fact never litigated in Canada. The
distinction between lower and higher life forms, though not explicit in the
Patent Act, is nonetheless defensible on the basis of the common sense
differences between the two. The non-patentability of human life is not explicit
in the Patent Act. If the line between lower and higher life forms is
indefensible and arbitrary, so too is the line between human beings and other
higher life forms. It is now accepted in Canada that lower life forms are
patentable but this does not necessarily lead to the conclusion that higher life
forms are patentable, at least in part for the reasons that it is easier to
conceptualize a lower life form as a "composition of matter" or "manufacture"
than it is to conceptualize a higher life form in these terms.
Patentable micro-organisms are formed in
such large numbers that any measurable quantity will possess uniform properties
and characteristics. The same cannot be said for plants and animals. It is far
easier to analogize a micro-organism to a chemical compound or another inanimate
object than it is to analogize an animal to an inanimate object. Moreover,
several important features possessed by animals distinguish them from both
micro-organisms and plants and remove them even further from being considered a
"composition of matter" or a "manufacture". Given the complexity of the issues
involved, it is not the task of the Court to situate the line between higher and
lower life forms. Also, the specific exception for plants and animals in trade
agreements demonstrates that a distinction between higher and lower life forms
is widely accepted as valid.
Per McLachlin C.J. and Major,
Binnie and Arbour JJ. (dissenting): The oncomouse is patentable subject
matter. The extraordinary scientific achievement of altering every single cell
in the body of an animal which does not in this altered form exist in nature, by
human modification of the genetic material of which it is composed, is an
inventive "composition of matter" within the meaning of s. 2 of the Patent
Act.
A.Statutory
Interpretation
Once it is acknowledged, as does the
majority of this Court, that the fertilized, genetically altered oncomouse egg
is an invention under the Patent Act, there is no basis in the statutory
text to conclude that the resulting oncomouse, that grows from the patented egg,
is not itself patentable because it is not an invention. Since the respondent
has fulfilled the other statutory criteria for an invention, it is entitled to
the patent.
The context and scheme of the Patent Act reinforce the expansive sense of
the words "composition of matter" to render the oncomouse patentable. The proper
question is not whether Parliament intended to include "oncomice" or "higher
life forms" or biotechnology generally in patent legislation, but whether
Parliament intended to protect "inventions" that were not anticipated at the
time of enactment of the Patent Act, or indeed, at any time before the
claimed invention. While Parliament did not contemplate the oncomouse in 1869
when it enacted the definition of "invention", it did not contemplate moon
rockets, antibiotics, telephones, e-mail or hand-held computers either.
The intent that can properly be
attributed to Parliament, based on the language it used and the context of
patent legislation generally, is that it considered it to be in the public
interest to encourage new and useful inventions without knowing what such
inventions would turn out to be and to that end inventors who disclosed their
work should be rewarded for their ingenuity. The Commissioner of Patents was
given no discretion to refuse a patent on the grounds of morality, public
interest, public order, or any other ground if the statutory criteria are met.
B.The
International Context
The mobility of capital and technology
makes it desirable that comparable jurisdictions with comparable intellectual
property legislation arrive at similar legal results. The expression
"composition of matter" is found in the U.S. Patent Act, under which the
oncomouse was patented in 1988. The oncomouse is also patented in jurisdictions
that cover Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland,
Italy, Luxembourg, The Netherlands, Portugal, Spain, Sweden and the United
Kingdom. A similar patent has been issued in Japan. New Zealand has issued a
patent for a transgenic mouse that has been genetically modified to be
susceptible to HIV infection. The Commissioner's approach to this case sounds a
highly discordant note. The massive private sector investment in
biotechnological research is exactly the sort of research and innovation that
the Patent Act was intended to promote. Healthcare is the major
beneficiary of biotechnology. At the same time, vast amounts of money must be
found to finance biomedical research. The Patent Act embodies the public
policy that those who directly benefit from an invention should be asked,
through the patent system, to pay for it, at least in part.
C.The
Line-Drawing Exercise
The Commissioner is unable to show any
statutory authority for drawing a line between those life forms that he
acknowledges to be patentable and those he rejects. "Composition of matter" is
an open-ended expression and is not confined to inanimate matter. While as a
matter of law there can be no patent on a human being, the Patent Act
does not distinguish, in its definition of invention, between "lower" and
"higher" life forms. None of the proposed dividing lines between "lower" and
"higher" life forms arise from the text of the Patent Act. Whether to
carve out a subject-matter exception for "higher life forms", and how "higher
life form" is to be defined, is a policy matter for Parliament.
As to the contention that growth from a
single fertilized cell to the complete mouse has nothing to do with the
inventors and everything to do with the "laws of nature", it must be said that
the "laws of nature" are an essential part of the working of many and probably
most patented inventions. Pharmaceutical drugs utilize the normal bodily
processes and functions of animals and humans and are not on that account
regarded as less patentable. Medications, like the oncomouse, could not be
brought into existence without reliance on the "laws of nature" in general and
the processes of biochemistry in particular.
D.The Plant
Breeders' Rights Act
The adoption of the Plant Breeders'
Rights Act in 1990 does not mean that the subject matter of patents excludes
plants and, by extension, other "higher" life forms such as seeds and animals.
The rights available under the Plant Breeders' Rights Act fall well short
of those conferred by patent, both in comprehensiveness and duration. In
addition, the Patent Act language reaches back prior to Confederation.
There was no repeal by implication in 1990 since it cannot be said that the two
Acts are inconsistent.
E.Other
Objections
As to the lack of a regulatory framework
for "higher life form" inventions, there are as many areas of potential
regulation as there are areas of invention. These regulatory regimes cannot and
should not all be put under the inadequate umbrella of the Patent Act. It
is normal that regulation follows, rather than precedes, the invention.
The scientific accomplishment manifested
in the oncomouse is profound and far-reaching. Every cell in the animal's body
has been altered in a way that is highly important to scientific research. While
the oncomouse is deliberately designed to grow painful malignant tumours,
animals will continue to be used in laboratories for scientific research whether
patented or not. With respect to the commodification of human life, the
patentability of humans is precluded by law and the broadest claim here
specifically excepts humans from the scope of transgenic mammals. Environmental
concerns which include the diversity of the gene pool and the potential escape
of genetically modified organisms into the environment are serious. They have
little to do, however, with the patent system. The Patent Act has always
had the modest and focussed objective of encouraging the disclosure of the fruit
of human inventiveness in exchange for the statutory rewards. The balance
between the other competing policy considerations is for Parliament to strike.
F.The Court's
Moratorium
Neither the Commissioner nor the courts
have the authority to declare a moratorium on "higher" life patents until
Parliament chooses to act.
Cases Cited
By Bastarache J.
Referred to: Commissioner of
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Théberge v. Galerie d'Art du Petit
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APPEAL from a judgment of the Federal
Court of Appeal, [2000] 4 F.C. 528, 189 D.L.R. (4th) 385, 7 C.P.R. (4th) 1,
[2000] F.C.J. No. 1213 (QL), reversing a decision of the Trial Division, [1998]
3 F.C. 510, 146 F.T.R. 279, 79 C.P.R. (3d) 98, [1998] F.C.J. No. 500 (QL).
Appeal allowed, McLachlin C.J. and Major, Binnie and Arbour JJ. dissenting.
Graham Garton, Q.C., and
Frederick B. Woyiwada, for the appellant.
A. David Morrow, Steven B.
Garland, and Colin B. Ingram, for the respondent.
William J. Sammon, for the
interveners Canadian Council of Churches and Evangelical Fellowship of Canada.
Michelle Swenarchuk, Theresa
McClenaghan, and Paul Muldoon, for the interveners Canadian
Environmental Law Association, Greenpeace Canada, Canadian Association of
Physicians for the Environment, Action Group on Erosion, Technology and
Concentration, and Canadian Institute for Environmental Law and Policy.
Written submissions only by Jerry V.
DeMarco for the intervener Sierra Club of Canada.
Written submissions only by Clayton C.
Ruby and Lesli Bisgould for the interveners Animal Alliance of
Canada, International Fund for Animal Welfare Inc. and Zoocheck Canada Inc.
PARAGRAPH NUMBERING
The reasons are published in the SCR by order of precedence and the paragraph
numbering included in those reasons has been prepared accordingly. For this
case, the reasons will be published in the following order:
Binnie J. (and McLachlin C.J. and Major and Arbour JJ.) [paras. 1 to 117]
Bastarache J. (and L'Heureux-Dubé, Gonthier, Iacobucci and LeBel JJ.) [paras.
118 to 207]
CITATION
Before publication in the S.C.R., this judgment should be cited using the
neutral citation: President and Fellows of
Harvard College v. Canada
(Commissioner of Patents),
2002 SCC 76. Once the judgment is published in the S.C.R., the neutral citation
should be used as a parallel citation: President and
Fellows of Harvard
College v. Canada (Commissioner of Patents),
[2002] x S.C.R. xxx, 2002 SCC 76.
BINNIE
J. __
1 The biotechnology
revolution in the 50 years since discovery of the structure of DNA has been
fuelled by extraordinary human ingenuity and financed in significant part by
private investment. Like most revolutions, it has wide ramifications, and
presents potential and serious dangers as well as past and future benefits. In
this appeal, however, we are only dealing with a small corner of the
biotechnology controversy. We are asked to determine whether the oncomouse, a
genetically modified rodent with heightened genetic susceptibility to cancer, is
an invention. The legal issue is a narrow one and does not provide a proper
platform on which to engage in a debate over animal rights, or religion, or the
arrogance of the human race.
2 The oncomouse has been
held patentable, and is now patented in jurisdictions that cover
Austria, Belgium, Denmark, Finland,
France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal,
Spain, Sweden, the United Kingdom and the United States. A similar patent has
been issued in Japan. New Zealand has issued a patent for a transgenic mouse
that has been genetically modified to be susceptible to HIV infection. Indeed,
we were not told of any country with a patent system comparable to Canada's (or
otherwise) in which a patent on the oncomouse had been applied for and been
refused.
3 If Canada is to stand
apart from jurisdictions with which we usually invite comparison on an issue so
fundamental to intellectual property law as what constitutes "an invention", the
respondent, successful everywhere but in Canada, might expect to see something
unique in our legislation. However, one looks in vain for a difference in
definition to fuel the Commissioner's contention that, as a matter of
statutory interpretation, the oncomouse is not an invention. The truth is
that our legislation is not unique. The Canadian definition of what constitutes
an invention, initially adopted in pre-Confederation statutes, was essentially
taken from the United States
Patent Act of 1793, a definition generally attributed to Thomas
Jefferson. The United States patent on the oncomouse was issued 14 years ago. My
colleague, Bastarache J., acknowledges that the fertilized, genetically altered
oncomouse egg is an invention under our Patent Act, R.S.C. 1985,
c. P-4 (para. 162). Thereafter, we part company, because my colleague goes on to
conclude that the resulting oncomouse, that grows from the patented egg,
is not itself patentable because it is not an invention. Subject matter
patentability, on this view, is lost between two successive stages of a
transgenic mouse's genetically pre-programmed growth. In my opinion, with
respect, such a "disappearing subject-matter" exception finds no support in the
statutory language.
4 A patent, of course,
does not give its holder a licence to practise the invention free of regulatory
control (any more than an unpatented invention enjoys such immunity). On
the contrary, the grant of a patent simply reflects the public interest in
promoting the disclosure of advancements in learning by rewarding human
ingenuity. Innovation is said to be the lifeblood of a modern economy. We
neglect rewarding it at our peril. Having disclosed to the public the secrets of
how to make or use the invention, the inventor can prevent unauthorized
people for a limited time from taking a "free ride" in exploiting the
information thus disclosed. At the same time, persons skilled in the art of the
patent are helped to further advance the frontiers of knowledge by standing on
the shoulders of those who have gone before.
5 The issues being thus
identified, I think the majority decision of the Federal Court of Appeal was
correct. The appeal should be dismissed.
A. Statutory Interpretation
6 The issue, in the words
of s. 2 of the Patent Act, is whether the oncomouse that has been
produced by a combination of genetic engineering and natural gestation is a
"composition of matter" that is new, unobvious and useful. If it is, then the
President and Fellows of Harvard University, who funded the research, are
entitled to a patent. My colleague, Bastarache J., writes of the oncomouse as
follows (at para. 163):
The fact that it has this predisposition
to cancer that makes it valuable to humans does not mean that the mouse, along
with other animal life forms, can be defined solely with reference to the
genetic matter of which it is composed. [Emphasis added.]
7 While acknowledging,
therefore, that the oncomouse is a "composition of [genetic] matter", my
colleague's contention is that the oncomouse is a "composition of [genetic]
matter" plus something else, undefined. The respondent, however, does not
claim to have invented the "plus". Its sole claim is to have modified what my
colleague describes as the "genetic matter of which [the oncomouse] is
composed", as described in the disclosure portion of the patent application:
(i)the desired oncogene is obtained from
the genetic code of a non-mammal source, such as a virus;
(ii)a vehicle for transporting the
oncogene into the mammal's chromosomes is constructed using a small piece of
circular bacterial DNA referred to as a plasmid; the plasmid is chemically cut
and the oncogene is chemically "spliced" into the plasmid;
(iii) the plasmid containing the oncogene
is then mechanically injected into
fertilized eggs at a site called the male pronucleus;
(iv)the eggs are then implanted in a host
mammal or "foster mother";
(v)the eggs are permitted to develop and
the offspring are delivered by the foster mother;
(vi)after delivery, the offspring are
tested for the presence of the oncogene; the offspring that contain the oncogene
are called "founder" animals;
(vii) founder animals are subsequently
mated with ordinary animals and
the offspring are again tested for the presence of the oncogene before the
offspring are used in research.
8 As will be explained
more fully below, I believe that the extraordinary scientific achievement of
altering every single cell in the body of an animal which does not in this
altered form exist in nature, by human modification of "the genetic material of
which it is composed", is an inventive "composition of matter" within the
meaning of s. 2 of the Patent Act.
9 The position taken by
the Commissioner of Patents is, I think, curious. While expressly acknowledging
that the oncomouse is new, useful and non-obvious, and therefore meets the usual
statutory criteria, the Commissioner of Patents denies that "higher life forms"
fall within the subject matter contemplated by Parliament as patentable.
He says, at para. 51 of his factum:
In 1869, when Parliament first made
provision for the patenting of "any new and useful ... manufacture, or
composition of matter", genetic engineering was unheard of. Thus, Parliament
could not at the time of enactment have intended that higher life forms
would come within the meaning of those words. [Emphasis added.]
10 It is true, of course,
that in 1869, when the post-Confederation patent act was passed, Parliament did
not contemplate genetically engineered "higher life forms" (Act respecting
Patents of Invention, S.C. 1869, c. 11). Parliament in 1869 did not
contemplate genetically engineered "lower life forms" either, although in
recent years Canadian patents have regularly been issued for such inventions.
(My colleague, Bastarache J., at para. 201, affirms that "lower life" forms will
continue to be patentable.) Nor did Parliament in 1869 contemplate moon rockets,
antibiotics, telephones, e-mail or hand-held computers. The proper question is
not whether Parliament intended to include "oncomice" or "higher life forms" or
biotechnology generally in patent legislation, but whether Parliament intended
to protect "inventions" that were not anticipated at the time of enactment of
the Patent Act, or indeed, at any time before the claimed invention.
11 I accept, as does my
colleague, that the proper approach to interpretation of this statute is to read
the words "in their entire context and in their grammatical and ordinary sense
harmoniously with the scheme of the Act, the object of the Act, and the
intention of Parliament": Driedger, Construction of Statutes (2nd ed.
1983), at p. 87. In my opinion, with respect, the context and scheme of the
Patent Act reinforce the expansive sense of the words "composition of
matter" to render the oncomouse patentable. The intent that can properly be
attributed to Parliament, based on the language it used and the context of
patent legislation generally, is that it considered it to be in the public
interest to encourage new and useful inventions without knowing what such
inventions would turn out to be and to that end inventors who disclosed their
work should be rewarded for their ingenuity. A further indication of
Parliament's intent is that the Commissioner of Patents was given no
discretion to refuse a patent on the grounds of morality, public interest,
public order, or any other ground if the statutory criteria are met: Patent
Act, s. 40. In my view, the respondent has fulfilled the statutory criteria
and "by law" is entitled to the patent.
B. International Scope of Intellectual
Property Law
12 Intellectual property
has global mobility, and states have worked diligently to harmonize their
patent, copyright and trademark regimes. In this context, the Commissioner's
approach to this case sounds a highly discordant note. Intellectual property was
the subject matter of such influential agreements as the International
Convention for the Protection of Industrial Property (Paris Convention)
as early as 1883. International rules governing patents were strengthened by the
European Patent Convention in 1973, and, more recently, the World Trade
Organization Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS) in 1994. Copyright was the subject of the Berne
Convention for the Protection of Literary and Artistic Works in 1886,
revised by the Berlin Convention of 1908 and the Rome Convention
of 1928. The Universal Copyright Convention was concluded in 1952.
Legislation varies of course, from state to state, but broadly speaking
Canada has sought to harmonize its
concepts of intellectual property with other like-minded jurisdictions.
13 The mobility of
capital and technology makes it desirable that comparable jurisdictions with
comparable intellectual property legislation arrive (to the extent permitted by
the specifics of their own laws) at similar legal results: Théberge v.
Galerie d'Art du Petit Champlain inc., 2002 SCC 34, at para. 6.
14 The appellant
Commissioner's definition of unpatentable "higher life forms" includes
not only animals but also plants and seeds. Genetically modified foods are
controversial, but these are not controversies that should be dealt with by
judicial exclusion of "higher life forms" from the definition of "an invention".
Parliament itself has clearly signalled its limited view of the role and
function of the Patent Act. In 1993, it repealed the prohibition in the
former s. 27(3) of the Patent Act against patenting "an invention that
has an illicit object in view". It thereby made it clear that granting a patent
is not an expression of approval or disapproval. At that time, Parliament did
not add a provision, present in the European Patent Convention and in
many civil law systems and international agreements, that patents will not be
granted for inventions whose use or exploitation would be inconsistent with
ordre public, public morality, or environmental or health protection. That
type of provision would open the door to value judgments in assessing
patentability. Parliament did not endorse such an approach, even though the 1993
amendments were introduced to bring Canadian patent law into compliance with
various international agreements. Parliament thereby signalled, however
passively, that these important aspects of public policy would continue to be
dealt with by regulatory regimes outside the Patent Act.
15 A more recent
indication of the government's approach is the Assisted Human Reproduction
Act. A discussion paper was placed before the Canadian public in 2000 and a
bill placed before Parliament by the Minister of Health as Bill C-56 on
May 9, 2002 (re-introduced in the
same form as Bill C-13 on October 9, 2002). The bill would prohibit the cloning
of human beings, modifying the germ line identity of human beings and the use of
human embryos for industrial or commercial purposes. At the same time, Bill C-13
would not prevent inventions in that regard from being patented in
Canada. This illustrates, again, the fundamental distinction made by Parliament
between patentability of an invention and regulation of activity associated with
an invention.
C. The Commercial and Scientific Context
16 Biotechnology is
global in scope. Worldwide demand is expected to more than double from $20
billion in 1995 to $50 billion by 2005.
Canada is a significant player. Statistics Canada reports that
Canada's biotechnology sector in 1999 generated almost $2 billion in revenues,
including $718 million in exports. These revenues are expected to exceed $5
billion in 2002. The Canadian Biotechnology Advisory Committee (CBAC), formed in
1999 to advise the federal government on these matters, recently reported that
Canada has more biotechnology companies per capita than any other
country: Patenting of Higher Life Forms and Related Issues: Report to
the Government of Canada Biotechnology Ministerial Coordinating Committee,
June 2002, p. 2. It was calculated by Ernst & Young in its Seventh Annual
European Life Sciences Report 2000, that Canada is second behind the U.S. in
terms of number of companies, third behind the U.S. and U.K. in revenues, and
first in R&D per employee.
17 Genetic tests and
"engineered" products hold out the possibility of modifying genetic mutations
that either cause a disorder (e.g., Tay-Sachs disease, cystic fibrosis,
Huntington's disease) or are responsible for increasing an individual's risk to
develop, at some point during his or her lifetime, a particular disease (e.g.,
breast cancer). In addition, some research indicates a genetic element in some "behavioural
illnesses" such as schizophrenia, Alzheimer's, autism, attention-deficit
hyperactivity disorder, and Tourette's syndrome: P. S.
Florencio, "Genetics, Parenting, and Children's Rights in the Twenty-First
Century" (2000), 45 McGill L.J. 527, at p. 535.
18 This is not to suggest
that because something is beneficial it is necessarily patentable. As stated,
such value judgments have been excluded from the administration of the Patent
Act. It is to say, however, that the massive investment of the private
sector in biotechnical research is exactly the sort of research and innovation
that the Patent Act was intended to promote.
D. Financing Research and Development
19 As this case
demonstrates, even university research has to be paid for, and intellectual
property rights are an important contributor.
20 We are told that in
the United States (comparable statistics do not seem to be available in Canada),
a health-related biotechnology product on average costs between 200 and 350
million dollars (U.S.) to develop, and takes 7 to 10 years from the research and
development stage to bring it to market (Biotechnology Use and Development __
1999, Statistics Canada (March 2001), at p. 25). One would think it in the
public interest to shorten the time and reduce the cost of research designed to
minimize human suffering, and to reward those who develop research tools (such
as the oncomouse) that might make this possible, provided the inventors disclose
their work for others to build on.
21 Transgenic mice,
including the oncomouse, have a role of potential importance. The evidence is
that use of transgenic mice improves the effectiveness of the research that can
be done, and shortens the time required to produce results. As Dr. Philip Leder,
the co-inventor of the oncomouse, told a Congressional hearing in 1989:
In the past few weeks, the gene for
cystic fibrosis has been identified and the ability to replace this gene, for
example, in a mouse, with the defective human cystic fibrosis gene would
constitute an extremely powerful model system for the development of an
effective treatment.
For individuals and families at risk for
this and other diseases, this would represent a priceless asset.
(Quoted in T. Schrecker, et al.,
Ethical Issues Associated With the Patenting of Higher Life Forms (1997), at
pp. 25-26.)
22 Dr. Leder's view is
widely shared:
Transgenic mice produced by DNA injection
have been employed in a vast range of studies. For instance the method allows
evaluation of the effects of gene mutations thought to be implicated in the
inception of cancer. It has also contributed greatly to our understanding of the
immune defence system. Indeed there are few areas of biology which have not been
illuminated by the study of transgenic mice.
(Extract from J. Bishop, Transgenic
Mammals (1999), at p. 7)
23 The CBAC report of
June 2002 observed that healthcare is the major beneficiary of biotechnology.
"More than 90 percent of the advanced biotechnology products on the world market
are related to health. It is expected that about three-quarters of global
biotechnology demand will continue to be in this area" (supra, p. 2).
Medical research inevitably relates to life, and its products will often
impinge, directly or indirectly, on "higher life forms".
24 The practical
application of biotechnology is in large measure the preoccupation of
enterprises that need to profit from their successes to finance continued
research on a broader front. These successes are few and far between (Biotechnology
Use and Development __ 1999, supra, at pp. 13-14). It seems Du Pont
spent about US $15 million to fund the oncomouse research: C. Arthur, "The onco-mouse
that didn't roar" (1993), 138 New Scientist 4. Leder, the afore-mentioned
co-inventor of the Harvard mouse, made the point to Congress as follows:
[T]he great and costly engine for
invention can only be effectively driven with the support from the private
sector, motivated to serve a public need.
The patent system offers the only
protection available for the intellectual product of this research, and thus,
the only hope of a fair return against the great financial risks that investment
in biotechnology entails.
(Quoted in Schrecker, supra, at
p. 25)
25 There are those who
question the level of incentive required to induce sufficient research in the
biomedical field. Professor Richard Gold of
McGill University argues:
The argument for greater patent
protection should be understood for what it is: an attempt to maximize profit,
not to maximize levels of innovation. Clearly, a company would prefer to have as
large a monopoly as possible.... But patent law is not about individual profit
maximization; it is about maximizing the overall level of innovation in society.
The two do not necessarily go together.
(E. R. Gold, "Biomedical Patents and
Ethics: A Canadian Solution" (2000), 45 McGill L.J. 413, at p. 423)
Nevertheless it is indisputable that vast
amounts of money must be found to finance biomedical research. It is necessary
to feed the goose if it is to continue to lay the golden eggs. The Patent Act
embodies the public policy that those who directly benefit from an invention
should be asked, through the patent system, to pay for it, at least in part.
E. Patenting Life Forms in Canada
26 My colleague,
Bastarache J., comments that "[t]he patentability of lower life forms is not at
issue before this Court, and was in fact never litigated in Canada" (para. 198).
However, certain enzyme products (which are living matter) were held to be
patentable by this Court 60 years ago in Continental Soya Co. v. J. R. Short
Milling Co., [1942] S.C.R. 187, as were engineered micro-organisms used as
an antibiotic in Laboratoire Pentagone Ltée v. Parke Davis & Co., [1968]
S.C.R. 307.
27 The attempt to patent
life forms last came before this Court in
Pioneer Hi-Bred Ltd. v. Canada
(Commissioner of Patents),
[1989] 1 S.C.R. 1623. In
that case, a patent was sought for a new soybean variety developed from
artificial crossbreeding and selection, but cultivated naturally. The
applicant's "disclosure" consisted of depositing seed samples with the Patent
Office. This Court upheld the rejection of the patent application on the basis
that filing a seed sample did not meet the disclosure requirements of s. 36(1)
of the Patent Act, R.S.C. 1970, c. P-4, which then (as now (s. 27(3))
required the inventor to set forth clearly the various steps required to make
the "composition of matter, in such full, clear, concise and exact terms as to
enable any person skilled in the art or science to which it pertains, or with
which it is most closely connected, to make ... it". In light of the deficient
disclosure, the Court expressly declined to go on to consider whether the new
soybean variety could be regarded as an invention within the meaning of s. 2.
28 In the course of his
reasons for the Court, however, Lamer J. (as he then was) pointed out an
important distinction between two approaches to "genetic engineering". The first
method (employed by Pioneer Hi-Bred) was hybridization and selection. In this
method, "[t]here is thus human intervention ... which does not alter the actual
rules of reproduction, which continues to obey the laws of nature"
(pp. 1632-33).
29 The second method
(which was used here to develop the oncomouse) requires
change in the genetic material __ an
alteration of the genetic code affecting all the hereditary material __ since in
the latter case the intervention occurs inside the gene itself. The change made
is thus a molecular one and the "new" gene is thus ultimately the result of a
chemical reaction, which will in due course lead to a change in the trait
controlled by the gene. While the first method [crossbreeding] implies an
evolution based strictly on heredity and Mendelian principles, the second also
employs a sharp and permanent alteration of hereditary traits by a change in the
quality of the genes. [p. 1633]
30 I do not think
Lamer J. expressed any doubt that an "alteration of the genetic code affecting
all the hereditary material" produced "an invention" (although he did not decide
the point). His doubts seemed rather to be related to whether crossbreeding
without altering the genetic code using modern variants of techniques that
are almost as old as agriculture itself was inventive within the scope of the
Act:
The courts have regarded creations
following the laws of nature as being mere discoveries the existence of which
man has simply uncovered without thereby being able to claim he has invented
them. Hi-Bred is asking this Court to reverse a position long defended in the
case law. [p. 1634]
The Harvard researchers did not merely
"uncover" a naturally occurring oncomouse. The complexity of the genetic
splicing did not "follow" the laws of nature, but was a human intervention of a
high order. They engineered that part of its genetic code that appears to be
responsible for its commercial value.
31 Reference should also
be made to Re Application of Abitibi Co. (1982), 62 C.P.R. (2d) 81
(Patent Appeal Board), in which the applicant sought to patent a living
organism, namely a "mixed fungal yeast culture system" (p. 83) useful in
digesting effluent from wood pulp mills. In holding the subject matter to be
patentable, the Patent Appeal Board rejected the Patent Office's somewhat narrow
view "derived from a time when the many gradations of living forms were not as
fully apprehended as is now possible" (General Electric Co.'s Application
(Patent), [1961] R.P.C. 21, at p. 25, cited in Abitibi at p. 85).
Somewhat in advance of its time, the Patent Appeal Board in Abitibi then
commented at p. 90 that "[i]f an inventor creates a new and unobvious insect
[i.e., a "higher life form"] which did not exist before (and thus is not
a product of nature), and can recreate it uniformly and at will, and it is
useful (for example to destroy the spruce bud worm), then it is every bit as
much a new tool of man as a micro-organism" and thus, subject to certain
conditions as to reproducibility, patentable. In relation to the Abitibi
micro-organism at hand, the Patent Appeal Board ruled (at p. 91):
The organism, to be claimed, should not
of course have existed previously in nature, for in that event the "inventor"
did not create it, and his "invention" is old. It must also be useful, in the
sense that it carries out some useful known objective, such as separating oil
from sand, producing antibiotics or the like. It cannot be a mere laboratory
curiosity whose only possible claim to utility is as a starting material for
further research. And it must be sufficiently different from known species that
it can be said that its creation involved the necessary element of inventive
ingenuity. In the present case we believe the product claims meets these tests,
and the [Patent Office] objection should be withdrawn.
32 In Re Application
for Patent of Connaught Laboratories (1982), 82 C.P.R. (2d) 32, the Patent
Appeal Board allowed that cell lines derived from "higher life forms" were
patentable, thus removing another possible dividing line. Not all aspects of
"higher life forms" were unpatentable. The Patent Office (now the Canadian
Intellectual Property Office) regularly allows patents on human genes, proteins,
cells and DNA sequences. Under Canadian law, it is not "life" per se
which is unpatentable. The issues are, rather, the view taken by the
Commissioner to narrow the range of living matter to be considered patentable,
and where in the Patent Act is there statutory authority for the line the
Commissioner wants to draw?
F. Patenting of "Higher Life Forms" in
Comparable Jurisdictions
33 In 1873, Louis Pasteur
was granted a patent in the
United States on a certain yeast, which is a living organism.
34 A patent for the
Harvard oncomouse was issued by the United States Patent Office on
April 12, 1988 and by the European
Patent Office on May 13, 1992, despite the explicit power under the European
Patent Convention to refuse a patent based on "morality" or "ordre public".
As mentioned earlier, a similar patent has been issued in Japan, and New Zealand
has issued a patent for a transgenic mouse.
35 The appellant
Commissioner's principal argument is that to allow the oncomouse patent would be
to "expand" the scope of the Patent Act (i.e., his factum, paras. 2, 3,
35, 73), but the opposite conclusion reached in so many countries with
comparable legislation suggests the contrary. In those jurisdictions, patents
for the oncomouse have been issued without any need for legislative amendment,
including the United States
where the language of our definition of "invention" originated. The Commissioner
seeks to restrict the legislative definition of invention, and he does so
(in my view) for policy reasons unrelated to the Patent Act or to its
legitimate role and function.
36 The majority of the
Federal Court of Appeal in this case found persuasive the interpretative
principles applied by the United States Supreme Court in Diamond v.
Chakrabarty, 447 U.S. 303 (1980). In that case the inventor, Al Chakrabarty,
had genetically engineered bacteria capable of breaking down crude oil spills.
The invention was environmentally useful but the bacteria, necessarily, were
alive. One of the arguments made by the U.S. Commissioner of Patents and
Trademarks, echoed in this appeal before us 22 years later, was that
micro-organisms cannot qualify as
patentable subject matter until Congress expressly authorizes such protection.
[The Commissioner's] position rests on the fact that genetic technology was
unforeseen when Congress enacted § 101. From this it is argued that resolution
of the patentability of inventions such as respondent's should be left to
Congress. The legislative process, the [Commissioner] argues, is best equipped
to weigh the competing economic, social, and scientific considerations involved,
and to determine whether living organisms produced by genetic engineering should
receive patent protection. [p. 314]
37 Burger C.J.'s answer
(at p. 315), also applicable here, was that "[i]t is, of course, correct that
Congress, not the courts, must define the limits of patentability; but it is
equally true that once Congress has spoken it is `the province and duty of the
judicial department to say what the law is'". The 5-4 majority held at
pp. 309-10 that the inventor's micro-organism
plainly qualifies as patentable subject
matter. His claim is not to a hitherto unknown natural phenomenon, but to a
nonnaturally occurring manufacture or composition of matter __ a product of
human ingenuity "having a distinctive name, character [and] use". [Emphasis
added.]
The proper distinction was not living
versus inanimate but between the discovery of a product of nature
(whether living or not) versus a human-made invention. Burger C.J.
did not subscribe to the notion that patents could be obtained for "anything
under the sun that is made by man", quoted as part of his narrative in
footnote 6. In fact, at p. 309, he specifically states that "[T]his is not to
suggest that [the Act] has no limits or that it embraces every discovery". On
the contrary, the patent issued because its subject matter was held to be a
"manufacture" or "composition of matter" within the statutory test laid down by
Congress. "A rule that unanticipated inventions are without protection would
conflict with the core concept of the patent law that anticipation undermines
patentability" (Chakrabarty, at p. 316).
38 The appellant
Commissioner argues that Chakrabarty should be rejected because of
differences he perceives in the legislative history in Canada and the United
States, an allegedly different common understanding of what "composition of
matter" meant when the Patent Act was passed in 1869, and subsequent
legislative action in Canada in 1990 with respect to plant breeders (factum, at
paras. 60 and 61).
In my view, for reasons given below, these distinctions are not
well founded but, in any event, the only interest we have in Chakrabarty
is the extent to which its reasoning adds persuasive force to the respondent's
argument and confirms harmony, broadly speaking, in intellectual property
matters among like-minded jurisdictions.
G. The Interpretation of Section 2 of the
Patent Act
39 The appellant
Commissioner denies that a patent can be obtained in
Canada for "anything under the sun that is
made by man" and I agree. He says that this expression, used in Congressional
hearings in 1952, distinguishes the U.S. legislative history from ours, but this
is not so, strictly speaking. A 1952 expression of opinion by a Congressional
Committee almost 150 years after the definition was inserted into the U.S.
Patent Act of 1793 is scarcely contemporanea expositio.
40 The check on the
indiscriminate grant of patents lies in the established criteria of utility,
novelty and non-obviousness. Those are the criteria judged by Parliament to be
relevant to its statutory purpose, which is to encourage ingenuity by rewarding
its disclosure. The expression "composition of matter" was included in our
patent laws prior to Confederation. It appears in 1824 in the Lower Canada
statute entitled An Act to promote the progress of useful Arts in this
Province, 4 Geo. 4, c. 25, and in Upper Canada two years later in An Act
to Encourage the Progress of Useful Arts within this Province, 7 Geo. 4,
c. 5. The 1826 Act included the terms "manufacture" and "composition of matter"
in the preamble setting out its object:
Whereas it is expedient for the
encouragement of Genius and of Arts in this Province to secure an exclusive
right to the Inventor of any New and Useful Art, Machine, Manufacture, or
Composition of Matter ...
41 Section 91(22) of the
Constitution Act, 1867, assigned legislative competence in respect of
"Patents of Invention and Discovery" to Parliament which two years later defined
patentable subject matter as follows:
Any person ... having invented or
discovered any new and useful art, machine, manufacture, or composition of
matter, or any new and useful improvement on any art, machine, manufacture or
composition of matter, not known or used by others before his invention or
discovery thereof, or not being at the time of his application for a patent in
public use or on sale in any of the Provinces of the Dominion with the consent
or allowance of the inventor or discoverer thereof ... [Emphasis added.]
(Patent Act, S.C. 1869, c. 11, s.
6)
The wording has not changed much in the
intervening years, apart from dropping the reference to "discovery". Section 2
of the present Patent Act now provides as follows:
"invention" means 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.
«
invention » Toute réalisation, tout procédé, toute machine, fabrication ou
composition de matières, ainsi que tout perfectionnement de l'un d'eux,
présentant le caractère de la nouveauté et de l'utilité.
42 It is common ground
that to meet the subject matter criteria of the Patent Act the oncomouse
must qualify as a "composition of matter" or a "manufacture".
(i) "Composition of Matter"
43 "Composition of
matter" (composition de matières) is an open-ended expression. Statutory
subject matter must be framed broadly because by definition the Patent Act
must contemplate the unforeseeable. The definition is not expressly confined to
inanimate matter, and the appellant Commissioner agrees that composition of
organic and certain living matter can be patented. In the case of the oncomouse,
the modified genetic material is a physical substance and therefore "matter".
The fertilized mouse egg is a form of biological "matter". The combination of
these two forms of matter by the process described in the disclosure is thus, as
pointed out by Rothstein J.A. ([2000] 4 F.C. 528, at para. 120), a "composition
of matter".
44 What, then, is the
justification under the Patent Act for drawing a line between certain
compositions of living matter (lower life forms) and other compositions
of living matter (higher life forms)?
45 My colleague,
Bastarache J., quotes from the Oxford English Dictionary (2nd ed. 1989)
vol. IX, at p. 480, the entry that "matter" is a "[p]hysical or corporeal
substance in general ..., contradistinguished from immaterial or incorporeal
substance (spirit, soul, mind), and qualities, actions, or conditions", but
this, of course, depends on context. "Matter" is a most chameleon-like word. The
expression "grey matter" refers in everyday use to "intelligence" __
which is about as incorporeal as "spirit" or "mind". Indeed, the same
Oxford editors define "grey matter"
as "intelligence, brains" (New Shorter Oxford English Dictionary (1993),
vol. 1, p. 1142). The primary definition of matter, according to the
Oxford English Dictionary, is "[t]he substance, or the substances
collectively, out of which a physical object is made or of which it consists;
constituent material" (at p. 479). The definition of "matière" in Le
Grand Robert, quoted by my colleague, is to the same effect. The question,
then, is what, in the Commissioner's view, is the "constituent material"
of the oncomouse as a physical entity? If the oncomouse is not composed of
matter, what, one might ask, are such things as oncomouse "minds" composed of?
The Court's mandate is to approach this issue as a matter (that slippery word in
yet another context!) of law, not murine metaphysics. In the absence of any
evidence or expert assistance, the Commissioner now asks the Court to take
judicial notice of the oncomouse, if I may use Arthur Koestler's phrase, as a
"ghost in a machine" but this pushes the scope of judicial notice too far. With
respect, this sort of literary metaphor (or its dictionary equivalent) is an
inadequate basis on which to narrow the scope of the Patent Act, and thus
to narrow the patentability of scientific invention at the dawn of the third
Millennium.
(ii) Defining
the Exception for "Higher Life Forms"
46 The appellant
Commissioner says the Federal Court of Appeal erred by allowing a patent on a
"higher intelligent life form", but he himself offers no definition of an
"intelligent" life form, much less does he identify a dividing line between a
"higher" intelligent life form and a "lower" intelligent life form.
47 The Patent Act
does not distinguish, in its definition of invention, between subject matter
that is less complex ("lower life forms") and subject matter that is more
complex ("higher life forms"). The degree of complexity is not a criterion found
in the Act or in the jurisprudence in determining patentability. The distinction
between "lower life forms" and "higher life forms" in its application to s. 2 is
the invention of the Patent Office.
48 While refusing to
issue a patent for a higher animal life form in this case, the Commissioner has
issued patents under the Patent Act for higher plant life forms: see,
e.g., Canadian Patent 1,313,830 issued February 23, 1993 for "Round-up Ready
Canola", a genetically modified plant, recently before the courts in Monsanto
Canada Inc. v. Schmeiser, [2002] F.C.J. No. 1209 (QL) (C.A.).
49 The CBAC report says,
at p. 6:
The term "higher life form" is not
defined in law. In common usage, it includes plants and non-human animals other
than single-celled organisms.
The line, on this view, is not drawn
between sentient beings and non-sentient beings or intelligent beings and
unintelligent beings, but between simple one-cell organisms (such as bacteria)
and their more complicated cousins, perhaps as rudimentary as moulds or other
fungi.
50 Other approaches
abound. In a paper prepared for the Intellectual Property Policy Directorate of
Industry Canada, A Study
of Issues Relating to the Patentability of Biotechnological Subject Matter
(1996), J. R. Rudolph offered the following explanation, at pp. 11-12:
Microorganisms are a large and diverse
group of organisms consisting of only one cell or cell clusters of prokaryotic
or eucaryotic cells. Examples of eukaryotic organisms are algae, fungi, molds
and yeasts. An example of prokaryotes is bacteria. An important distinction
between single cells or cell clusters which are microorganisms, and single cells
or cell clusters which are not microorganisms, is that microbial cells are able
to live alone in nature: single animal or plant cells or cell clusters are
unable to exist by themselves in nature and can only be successful in either a
specialized environment such as a culture system (typically created by man in
the laboratory) or as part of a multicellular organism such as a plant or
animal. The so-called "higher life forms" are complex multicellular organisms
such as simple plants or oysters, for example, which contain thousands or
hundreds of thousands of cells. The human, which is a complex multicellular
organism, has been estimated to contain at least 1014 cells. [Emphasis added.]
51 My colleague,
Bastarache J., takes the view that a key factor is "the unique ability of higher
life forms to self-replicate" (para. 170), but in fact self-reproduction is also
a fundamental characteristic of "lower life forms". Indeed, one of the most
widely held objections to the genetically engineered bacteria in the
Chakrabarty case was the potential for such unnatural bacteria to escape and
reproduce in the wild with unknown consequences for the environment.
52 The various
distinctions attempted to be made between "patentable" lower life composition of
matter and "unpatentable" higher life composition of matter, shows, I
think, the arbitrariness of the Commissioner's approach. My colleague writes at
para. 199:
The distinction between lower and higher
life forms, though not explicit in the Act, is nonetheless defensible on the
basis of common sense differences between the two.
With respect, there seems to be as many
versions of "common sense" as there are commentators:
(1)Some would say all living organisms
are excluded (e.g., Brennan J. for the dissenters in Chakrabarty);
(2)Some would allow micro-organisms but
only those that can be produced en masse with identical features, like
bacteria. In Re Abitibi, supra, the Patent Appeal Board
recommended that patents extend "to all new life forms which are produced en
masse as chemical compounds are prepared, and are formed in such large
numbers that any measurable quantity will possess uniform properties and
characteristics" (p. 89). "Mass" live organisms have a long history of
patentability, including food products such as beer and yogurt.
(3) Then there are the proponents of
"higher life" organisms versus "lower life" organisms, the latter being
defined by the CBAC as having only a single cell.
(4)Others divide the universe between
prokaryotic cells (e.g., bacteria and certain forms of algae) and
eukaryotic cells (more complex life forms) and consider "higher" life forms
to start only with more "complex" multicellular organisms.
(5)The Patent Appeal Board allowed
multi-celled organisms such as moulds and fungi in Connaught Laboratories,
supra.
(6)Some argue that "complex life forms"
are unpatentable. Nadon J. took this position at trial in this case, [1998] 3
F.C. 510, at para. 35.
(7)The Commissioner issues patents for
genetically modified complex plants (Monsanto, supra) but refuses
to issue a patent for a genetically modified complex mouse.
(8)Others draw the line at sentient
beings.
(9)Still others draw the line at
"intelligent" beings.
(10)The Commissioner opened his argument
in this case by asking whether "a complex intelligent living being could be
considered an invention".
53 In my view, none of
these proposed dividing lines arise out of the present text of the Patent Act.
All of them are policy driven and, if they are to be introduced at all, should
be introduced by Parliament.
54 The Federal Court of
Appeal and CBAC drew the line at human bodies in their entirety at any stage of
development, as discussed below. The true basis for the exclusion is not
extraneous to the Patent Act but lies in an explicit limitation in s. 40
which provides that:
40. Whenever the Commissioner is
satisfied that an applicant is not by law entitled to be granted a patent, he
shall refuse the application ... [Emphasis
added.] 40. Chaque fois que le commissaire s'est assuré que le demandeur
n'est pas fondé en droit à obtenir la concession d'un brevet, il rejette la
demande ... [Je souligne.] The
reference to "by law" is not limited to the Pat