22nd Street, N.W.
Washington, D.C. 20037
Friday, June 21, 2002
COUNCIL MEMBERS PRESENT
Leon R. Kass, M.D.,
American Enterprise Institute
Elizabeth H. Blackburn,
University of California, San Francisco
S. Dresser, J.D.
Washington University School of Law
W. Foster, M.D.
University of Texas, Southwestern Medical School
Johns Hopkins University
Michael S. Gazzaniga, Ph.D.
P. George, D.Phil., J.D.
Ann Glendon, J.D.,
B. Hurlbut, M.D.
William F. May,
Southern Methodist University
Johns Hopkins University School of Medicine
C. Meilaender, Ph.D.
D. Rowley, M.D., D.Sc.
The University of Chicago
J. Sandel, D.Phil.
Session 5: Regulation 3: Patentability of Human Organism 1: History and Current Law
Session 6: Regulation 4: Patentability of Human Organisms 2: Ethics and Public Policy
WELCOME AND OPENING REMARKS
CHAIRMAN KASS: Would the Council Members please join the table and take
their seats. Good morning. This morning will be devoted to two sessions
on the patentability of human organisms; the first session on history
and current law; and the second session on ethics and public policy.
The topic of the patenting of life, with special attention to the patenting
of human organisms, is a topic that we selected here for a number of reasons.
First of all, as part of a larger interest in the interaction between
biotechnology and society, the question of patenting policy is relevant.
Second, a number of the members of the council, going back to the very
first meeting, expressed an interest in the significance of the commercial
aspects of the new biomedical technology, and wondered about those special
ethical and policy questions that arise from commercialization.
Third, patent protection, though not primarily an instrument for regulation,
is nevertheless one area where this question of commercialization can
be explored. And though it does not serve as a regulator, it does work
as an accelerator, and therefore does have some considerable impact on
Fourth, as the staff has looked at documents and read case law, it seems
as if patenting of human organisms and their parts may at least, and following
the existing statute as the Supreme Court cases have interpreted them,
be at least silent on, and perhaps even allow for the patenting of human
life and human parts.
And one wonders whether there is an existing either ambiguity or lacuna
in the current law as interpreted on this question that would allow the
patenting of human organisms from embryos on up or the parts.
And we thought that we would investigate the question as to first of all
is there such a lacuna, and we are not experts in this matter. And second
is that lacuna a problem, and if so, why.
And if it does would that difficulty be sufficient to warrant a legislative
remedy, and I think those are the larger questions that we would to at
least think about with the help of our invited guests.
This morning, in considering the history and current law, we are very
fortunate to have two guests seated to my right. First, Daniel Kevles,
who is the Woodward Professor of History at Yale University; and a scholar
of the history of science and its interactions with society.
And second, Karen Hauda, who is a patent attorney in the Office of Legislative
and International Affairs at the United States Patent and Trademark Office,
and was for a while the patent examiner, or one of the patent examiners,
in gene therapy and transgenic animal art.
And we have asked Professor Kevles to talk about the history of patenting
life as it leads up to the question of human organisms. And Ms. Hauda
will speak about the existing state of the patent law, and try to educate
us about what goes on over there, and how it affects these questions.
The larger biographies of our guests are in the briefing book, and I won't
say any more about it. Professor Kevles has provided a wonderfully rich
and long paper, which I hope everybody has had a chance to read, and he,
I think, is going to begin here by summarizing, embellishing, or adding
to that, and let me without further ado please turn it over to Professor
SESSION 5: REGULATION 3: PATENTABILITY OF HUMAN ORGANISMS 1: HISTORY AND CURRENT LAW
PROF. KEVLES: Thank you very much, Dr. Kass, and a thank you to the Members
of the President's Council for this opportunity to tell you a bit about
this issue of patentability. I should say that I first got interested
in it in the late 1980s when the patent office announced that you could
get a patent on a mouse, a animal, and I just thought that it was intriguing,
and I began to wonder how in the world did this come about.
Obviously, there was a lot of controversy that surrounded it and so on,
and so I began looking into the issue, and since then have embarked on
writing a book about it, but got interrupted with a couple of other books
in the interim, and going back to writing a book about it now. So it is
particularly timely for me.
Very few people were interested in it in the late 1980s, but as is evidenced
by the invitation to me to appear before the President's Council, has
become a much more charged and important issue, not only in the United
States, but also in Europe.
What I am going to do is provide a summary of highlights of what I know
about this issue of this patenting of living organisms from the late 19th
century, and then provide some reflections on closing.
I have been asked to speak for about 20 minutes, and so I will arrange
my remarks to at least attempt to fall within that purview, and if I am
going on too long, Dr. Kass, would you please just give me a high sign
and I will finish.
Okay. First, with regard to patentability. The key issues or the key points
to make here as to what is patentable historically are that, first —
and this phrase was coined by Thomas Jefferson in the patent law of 1793,
that it must be, among other things, that the invention can be a new composition
Second, however, what is relevant to our concern is that in 1889 the Commissioner
of Patents ruled that you could not get a patent on a so-called product
of nature, something that you found in the fields, for example.
That doctrine had come and since then had played a role in limiting patentability
to non-living organisms. However, beginning in the early 20th century
after the rediscovery of Mendel's laws of genetics, and plant and animal
breeders begin to think that they might be able to acquire some sort of
patent protection for the products of their labors.
Their efforts, which produced in 1930 the Plant Patent Act. They argued,
that is, the plant breeders, and horticulturists, and so on, that they
had a right to be protected in the fruits of their labors just as did
physical inventors, like Thomas Edison.
The Congress agreed with them and passed the Plant Patent Act in 1930.
However, the coverage, or the scope of what was patentable under the Plant
Patent Act was limited for interesting reasons.
It is limited to asexually reproducing plants. For example, plants that
you can reproduce by cuttings, or vines, that tend to reproduce themselves
asexually. If you walk into your local nursery, for example, you often
find roses that say patented with a number.
And that is because a rose as you know can be reproduced by a cutting.
The reason for this limitation were that, first, in order to have a patent
it was assumed that you have to be able to control the product to produce
it identically at will; and secondly, that it must be highly specifiable.
The problem with sexually reproducing plants is that you cannot control,
or at least you could not control at that time what the offspring would
be like because of the mixing of genes from the two parents, and the changes
would arise over various generations.
And, secondly, it was very difficult to specify, partly because you can't
control it, but partly because it is a living organism, exactly what the
So on the assumption that no property right is worth anything if you can't
enforce it, and you can't enforce it if you can't specify the property,
the Congress decided to limit the coverage to asexually reproducing plants.
The next landmark in our story is a ruling by the United States Supreme
Court in 1980 in the case of Diamond versus Chakrabarty.
Chakrabarty was a biochemist at General Electric, and he devised a bacterium
in the early 1970s that was genetically modified so that it would consume
His claim for the patentability of this product rested in part on the
fact that the product was highly specific because it was genetically modified,
and by that time it was well established that genes are chemicals, and
therefore you could specify it as a composition of matter.
And furthermore, it could be controlled because of the constancy of the
genetic material. The Patent and Trademark Office, however, objected to
and rejected Chakrabarty's claim on the grounds of invoking the product
of nature doctrine from 1889, and it was a product of nature, and a living
organism, and then rejected it also on the grounds that it was alive.
And it cited the Plant Patent Act, reasoning that when Congress had passed
the Plant Patent Act, and it implicitly declared to extend the scope of
patentability to anything alive would require an act of Congress, and
of course here there had been no act of Congress.
Chakrabarty appealed the rejection, or to say that G.E. did on his behalf
through the courts, and hence the case reached the Supreme Court in late
1979, and the ruling came in 1980.
The ruling granted Chakrabarty his patent, but it was only by 5-to-4.
The Court said in response to the arguments made by Chakrabarty's lawyers
and also a number of friends of the court briefs, that the product, the
bacterium in question, was not a product of nature. It was a product of
Chakrabarty, and that it was in short man-made.
Furthermore, it was a new composition of matter because it had to do with
changing the chemical DNA in the product. And thirdly, and perhaps most
important, it ruled that whether an invention is alive or not is irrelevant
to its patentability.
The dissenters in the case, the four, held that this really was a charged
social issue. It arose at the time of the recombinant DNA wars in the
United States, and in Europe, and which opened up the prospect of the
engineering of all of life.
And given the charged nature of the case and its implications, the dissenters
held that really this should come before the Congress. However, the majority
disagreed and went on to rule as I have said.
During the arguments on the case, and as I said, a number of amicus briefs
were filed, and among them was one from the People's Business Commission
as was then called, which was the non-profit organization headed by Jeremy
Rifkin, who had already established himself as a staunch opponent of genetic
Among the numerous arguments raised in the PBC's brief was that there
were profound implications here that if you were to say that an organism
is patentable, and its being alive is irrelevant, and that anything that
is a new composition of matter could be patented, then that would leave
no logical space, or no logical obstacle, to the patenting of higher life
forms, including possibly human beings.
Observers in the wake of the court's ruling agreed with this reasoning
and warned of that possibility. The court at the time ruled or held in
its ruling that whether these implications might or might not be true,
but it could only decide the case before it which concerned the bacterium
and had been devised by Chakrabarty, and hence the ruling that I have
But the implications that were drawn were I think quite substantive and
material. As a result, in 1985, the patent office awarded a patent on
a plant, which meant that any plant could then be patented so long as
it qualified or met the criteria for patentability, including new composition
of matter, et cetera.
Then in 1987 the Board of Patent Appeals and Interferences in the Patent
Office ruled in a case, Extra Parte Allen, allowing in the
case of Ex Parte Allen, allowed the patenting of higher
organisms, including animals.
The case involved an oyster that had been chromosomally altered by a laboratory
at the University of Washington so that it would be sterile. It is always
amusing to me why they wanted to do this, and it turns out that this oyster
naturally spends three months of its life each year reproducing, and at
that time the flesh of the oyster is much less eatable.
So if you could force the oyster not to reproduce ever, then you could
have an increase in the eatability of these oysters by 33 percent over
time, and that would be a great boon to the oyster industry in Washington.
Well, the Patent Office, the examiners, initially ruled against the claim
on the grounds that the oyster was a product of nature and furthermore
that the modification that had been engineered into the oyster was obvious
to anyone schooled in the art of oyster breeding, and something that as
obvious as by patent practice not testable.
The Board of Patent Appeals and Interferences agreed with the reasoning
that it was obvious, but it held that a higher organism could be patented.
It cited Diamond v. Chakrabarty, and the doctrine of whether an
invention is alive or not is irrelevant and cited the point that new compositions
of matter were patentable.
At the same time, the Board revealed its sensitivity to the apprehensions
that emerged in the wake of Diamond v. Chakrabarty, namely the
apprehensions about the potential patentability of human beings. So it
declared that human beings are not patentable by reason of the 13th Amendment
to the United States Constitution.
The 13th Amendment, of course, overturned the Dred Scott case,
in which the Court in the 1850s did hold that one human being could hold
a property right in another. The 13th Amendment basically said by implication
that a human being cannot hold a property right in another, and a patent
is a form of intellectual property right.
So for one human being to hold an intellectual property right in another
human being is a violation of the 13th Amendment to the Constitution.
The next landmark and the final one for our purposes here is that in 1988
the court, basing its decision on Ex Parte Allen, or I mean
the Patent Office, basing its decision on Ex Parte Allen,
issued a patent without any objection whatsoever in the Patent Office,
to Harvard University for a mouse that had been genetically engineered
in its laboratories, to be supersusceptible to cancer.
Now, the reason that it was a new composition of matter is that it had
introduced into it at the stage of being a newly fertilized egg an oncogene,
and therefore, the oncogene being DNA, made the mouse a new composition
of matter and therefore under these accumulating precedents of Diamond
v. Chakrabarty, Hibberd, and Ex Parte Allen,
and the mouse was patented.
Now, what I want to conclude with is a set of observations concerning
the ethical issues as they arose either implicitly or explicitly in the
course of this history.
First, with regard to the patent system and the rights of inventors. One
reason for the patent system in the United States and in other countries
is of course for the practical purpose, the consequential purpose of encouraging
innovation, by securing to inventors the fruits of their labors.
But secondly there is an ethical premise it seems to me in that doctrine,
or in that policy, namely that inventors have a moral right to the fruits
of their labors. One can see this moral right invoked in the attempts
by breeders, for example, starting early in the 20th century to obtain
intellectual property protection in the plants that they would devise.
The moral right was expressed in a Congressional hearing in 1906, and
it certainly suffused the discussion and debates that preceded the Plant
Patent Act in 1930, without intellectual property protection, and without
the patent for the fruits of their labors in the case of plants, and it
was claimed that in fact that others would just simply steal from inventors,
and leave — that is, plant breeders, and leave them no recourse.
Secondly, since Diamond v. Chakrabarty, and the debates starting
actually in the '70s when the case was beginning to work its way through
the courts, but certainly since Diamond v. Chakrabarty in 1980,
and especially since the award of the patent to the Harvard mouse, opening
the door to animal patents, the ethical objections to patents have arisen.
The one class of these objections is to the patenting of life per se as
such, without regard to whether it is a plant, an animal, a human being,
This objection is to be found vigorously advocated in the brief of the
People's Business Commission, and before the Court in Diamond v. Chakrabarty,
but it has also found expression since then from clerics, from animal
rights activists, once Ex Parte Allen allowed the patentability
of animals, and so on, and also from certain groups of environmentalists.
The basic argument advanced in this ethical regard is that to patent life
is to hold that it has no vital or sacred character. That it is commidifiable
in ways that are no different from, say, tennis balls.
A second particular ethical objection, which is sort of a subset, but
important for our purposes, is that to allow the patenting of life, especially
animals, implies the potential patenting of human beings.
This possibility was disparaged in the amicus briefs on behalf of the
biotech industry, the American Pharmaceutical Manufacturers, and so on,
and Genentech, then a new company, in the debates over Diamond v. Chakrabarty before the court.
And saying that this is just carrying the doctrine of patentability of
living forms beyond reason. And that potential of patenting human beings
would seem to have been blocked entirely by Ex Parte Allen,
which says explicitly that you cannot get such a patent.
However, in the wake of the ruling of Ex Parte Allen allowing
animal patents, and then Harvard's mouse patent, there was sufficient
controversy that arose to prompt Congressman Robert Kastenmeier, who was
then head of the appropriate subcommittee of the House Judiciary Committee,
to hold hearings on the patenting of animals.
The ethical objections were raised but there were also other objections
raised to the patenting of animals, especially by farm groups, agricultural
groups, on the grounds that this was going to be disruptive to the agricultural
economy and work adversely against the interests of small farmers.
In a sense, it would be another case of how the advent of technology,
which may involve higher capital costs, tends to work or to favor better
capitalized or agricultural groups, and to disfavor those that are less
So there was a melange in the hearings of these ethical objections, plus
consequentialist objections, and one of the major conseqentialist objections
for everybody in the agricultural community, agri-business and small farmers,
was who owns the progeny in impacted animals.
This was an issue that had never arisen before in the system because no
invention had ever been capable of reproducing itself. But now with living
organisms, you did have such capability.
In the end, Kastenmeier and his subcommittee concluded that the ethical
objections had no place in the considerations of American patent law;
that U.S. patent law is literally amoral. All it does is to grant an exclusive
right to make, use, or sell an invention, or to exclude others from making,
using, or selling it.
But with regard to the ethical objections that the subcommittee held,
that Kasternmeier did, were excluded from American patent law, but did
have a place in public policy because even though a patent really grants
the exclusive right, it does not give you the right actually to make,
use, or sell an invention.
For example, just to take an extreme example, if you were to invent a
new nuclear weapon in your basement, you could get a patent on it. But
that wouldn't give you the right actually to make the weapon, or to sell
it, et cetera, et cetera.
That would obviously come under rules of national security, public health
and safety, and so on. And so Kastenmeier held, as did his subcommittee,
that the literal amoral nature of American patent law relegated to all
the regulatory safety agencies of the government, and to Congressional
action, the implicit ethical issues concerning these matters.
However, Congressman Kasternmeier did attempt, and did think it important
to deal with the consequentialist issues arising from the patentability
of animals, namely as they might affect farmers. And he constructed a
bill that in part held that the patent holders would not have rights in
the progeny of patented animals, simplifying the system, et cetera, and
assuming that therefore the price, the lack of property control over progeny
would be reflected in the initial price.
Secondly, however, he also included in his bill a provision by statute
that would prohibit the patenting of human beings. He was not satisfied
with the reliability of Ex Parte Allen, and so he incorporated
that provision into the bill.
This bill passed the House of Representatives in 1989, but it died in
the Senate, and since then there has been no action in the Congress. Then
finally what is the current state of affairs with regard to human beings.
Well, Ex Parte Allen still prevails, but it is still possibly
— I am not enough of a lawyer or patent policy expert to say, but possibly
it is vulnerable. It seems to me though to have a pretty solid foundation,
because it is not just a casual regulation. It is a legal ruling by the
Patent Office itself.
But even if Ex Parte Allen should remain a solid fixture
of American patent law, it omits consideration of what constitutes a human
being. Is it a human being in its totality only, or does it also its parts
— the organs of the human being, the liver, kidney, or whatever.
We do know that with regard to the patentability of those things that
there is precedent in the patentability of human genes. Human genes have
been patentable without objection initially since Genentec I think took
out the first human gene patents in the late 1970s.
The ethical objections have been raised to the patentability of human
genes, per se, but it seems to me that we have at least equal concerns,
or we should have equal concerns of a consequentialist nature.
Gene patents are treated as absolute property rights, and we can see already
that the way that private companies are dealing with their property rights
in human genes is creating problems for medical research, and already
even in the diagnostic area.
The medical research is problematic, and problems are arising in medical
research arise from the fact that expensive licensing fees are being charged
by some companies for people just to do research on these genes.
And it seems sort of paradoxical and bizarre to a number of observers
that if you wanted to take a gene from your own body and do research on
it that you can't do it without paying a license fee possibly to whoever
owns the patent.
Secondly, these genes are important, and a growing number of them are
in medical diagnostics because they can tell you, for example, which oncogene
has gone wrong in your body, et cetera, and give a much more specific
diagnosis of, say, cancer, and then you multiply those examples over a
number of diseases.
It seems to me that quite possibly the notion of gene patents at least
in human beings, and possibly other forms of possible patents in human
beings, ought to be explored as whether this should be an absolute property
My own view personally is that it ought not to be. One can make analogies
because it is a very limited resource. I mean, we have lots of genes,
but we only have a finite number of them, some thousands, 30 to 40,000
at current estimates, and obviously they are all very important to us,
especially with regard to biomedical research.
And one can analogize this limited resource to, for example, by riparian
rights, and there are other analogies that you could make in the history
of property law in the United States, possibly the electromagnetic spectrum.
But in the case of riparian rights, for example, we do not allow I think
in most States people through whose property water rivers run to treat
their property in an absolute way, because it is a public resource.
Downstream has interests in what is upstream, et cetera, and so all of
us have interests in what happens to human genes, and how they can be
used in biomedical research, and in diagnostics.
The bottom line for all of this in sort of summary it seems to me is that
there has been no adequate, despite the valiant efforts of Congressman
Kastenmeier, no adequate effort on the part of the Congress to explore
in a thoughtful way the — and in a sufficiently serious way, the sense
of being high enough on the public agenda to do something, adequate consideration
of the myriad issues arising from the patentability of living organisms,
but particularly in the human area.
I think that Ex Parte Allen is okay, and I don't think that
anybody would object to disallowing patents on human beings as a statutory
matter. But we have these other sort of infrastructural issues in human
beings, which are now increasingly on the front stage center of intellectual
property, biotechnology, biomedicine, and so on.
And it seems to me that there is more than a compelling reason for the
Congress, and possibly prompted by the deliberations of this council,
to examine in an serious way what these intellectual property rights might
be, and what their scope might be, and what their limitations might be.
CHAIRMAN KASS: Thank you very much. I think in the interest of making
sure that we have got full time for discussion that we should have the
second presentation, and then discuss the two together if that is all
right with everybody, unless there is something burning that anyone wants
to ask Mr. Kevles. Please, Ms. Hauda. Thank you.
MS. HAUDA: Good morning. I would like to thank Dr. Leon Kass, Chairman
of the President's Council on Bioethics, for inviting me here today on
behalf of the United States Patent and Trademark Office. I will refer
to this as the USPTO.
In my testimony, I will briefly outline the present state of the law and
current policy of the USPTO regarding the patenting of life forms. I then
will discuss recent technological developments that have raised new questions
concerning patent eligible subject matter.
We welcome the advice and guidance of the President's Council on Bioethics
as we consider these important issues. The President's Council on Bioethics
may also want to consider recommending that Congress clarify its intent
regarding patent-eligible subject matter.
The basis for the U.S. patent system is found in Article I, Section 8,
of the Constitution, which provides that Congress should have the power
to promote the progress of science and useful arts by securing for limited
times to inventors the exclusive right to their discoveries.
In response to this Constitutional authorization our founding fathers
designed an extremely flexible patent system based on principles that
have proven remarkably suitable to 210 years of unceasing technological
Basically, in exchange for the full disclosure of an invention meeting
the criteria of the patent law, the government grants the inventor of
a patent, that is, the right to exclude others from practicing the invention
for a limited time, now 20 years, from the filing date of the application.
Indeed, one of the key tenants of our patent system is that it is technologically
neutral. For example, from gear shifts to genomics, it applies the same
standards to all inventions in all technologies.
While some are critical of this aspect of the patent system, the uniformity
and applicability of the patenting standards of novelty, of obviousness
and utility, coupled with the incentives patents provide to invent, invest
in, and disclose new technology, have allowed millions of new inventions
to be developed and commercialized.
This has enhanced the quality of life for all Americans and helped fuel
our country's transformation from a small struggling nation to the most
powerful nation in the world.
In administering the patent system, USPTO takes its direction on what
subject matter is patentable from Congress and our review in Courts. The
current Act details the standards of patentability, and the Patent Act
of 1952 specifies four basic statutory requirements that must be met to
obtain a patent.
First, the claimed invention must be eligible subject matter and have
utility. Second, it must be novel. Third, it must not have been obvious
to a person having ordinary skill in the art at the time that the invention
was made; and, fourth, it must be fully disclosed in the text of the patent
application and enable a skilled practitioner to practice the invention
without undue experimentation.
Prior to granting a patent, the USPTO examines each patent application
to determine whether it meets these four criteria as set out in Title
35 of the United States Code. The pertinent statutory provisions defining
the subject matter that is eligible for patenting is 35 U.S.C. Section
101, titled, "Inventions Patentable."
This section reads whoever invents or discovers any new and useful process,
machine, manufacturer, or composition of matter, or any new and useful
improvement thereof, may obtain a patent therefore subject to the conditions
and requirements of this title.
Congress deliberately used expansive terms in describing in describing
the categories of inventions so that unforeseen technologies wouldn't
be included without the need for constantly updating the patent law.
The scope of patent eligible subject matter, however, is limited in part
by the product of nature judicial doctrine, which provides that naturally
occurring products are not patentable.
Under this doctrine, the mere discovery of a previously unknown naturally
occurring product is not patentable. The courts, however, have long held
that a purified composition of matter, such as a chemical compound isolated
from nature, is a human made invention eligible for patenting, rather
than an ineligible product of nature.
For example, purified prostaglandins isolated from human prostate glands
are not naturally occurring and are therefore patent eligible subject
matter because the pure form does not exist in nature.
Nevertheless, for many years the USPTO used the products of nature doctrine
as a bar to patent living subject matter. In 1980, the Supreme Court decided
the landmark case of Diamond v. Chakrabarty, addressing the patentability
of living subject matter, and specifically of genetically altered bacterium
capable of breaking down crude oil.
After a careful consideration of the history of Section 101, the Supreme
Court reversed the USPTO's position that microorganisms, even genetically
altered ones, were products of nature as living things, and were per se,
The Supreme Court held that the statutory language of Section 101 was
intended by Congress to be broad enough to include anything under the
sun that is made by man.
Under this analysis the Supreme Court held that a living man-made microorganism
qualifies as a manufacture or a composition of matter under the statute.
The court explained that the relevant distinction for the purposes of
patent eligibility was not between living and inanimate things, but between
products of nature, whether living or not, and human made inventions.
Consistent with the Chakrabarty decision, Federal Courts have routinely
upheld the patentability of products that have been modified or purified
from nature. In the wake of the Chakrabarty decision, the USPTO
has issued thousands of patents to living material, where the products
are the result of human intervention and do not exist naturally in that
form, provided that all other criteria of patentability are satisfied.
The USPTO issued the world's first transgenic animal patent in 1988 to
the now famous Harvard Onco-mouse, a mouse genetically engineered to be
more susceptible to tumor growth. Patents have since issued on numerous
other genetically altered plants and animals.
It should be noted, however, that in holding the microorganisms for patent
eligible subject matter, the Supreme Court was aware of the lower court's
view that we are not dealing with patent eligibility of all living things,
The USPTO concluded that inventions covering human beings are not within
the scope of Section 101, and in 1987, published a notice in the USPTO's
official gazette advising the public of its conclusions.
The USPTO concluded that Congress never intended for a human being to
be considered a manufacturer or a composition of matter under the patent
More recently, an immediate advisory issued in 1998, the USPTO reiterated
its policy that an invention, including within its scope a human being,
could not be considered to be patentable subject matter under 35 U.S.C.
Section 101 because it would be against public policy to do so.
Shortly after the USPTO published its notice of intent not to patent human
beings, it informed Congress of the decision by direct testimony in a
1987 hearing before a subcommittee of the Committee on Judiciary, House
of Representatives, on the patents on the Constitution of Transgenic Animals.
On June 11th, 1987 the USPTO's Assistant Commissioner testified that a
claim, including a human being within its scope, will not be considered
to be patentable subject matter.
In the 15 years since it was notified of the USPTO's interpretations,
Congress has apparently acquiesced to the USPTO interpretation. Further,
the Federal Circuit held in 1991 that the USPTO has the authority to establish
its policy through interpretative authority.
Guidance on the topic of patentability of living subject matter is provided
to the USPTO patent examiners and to the public in Section 2105 of the
USPTO Manual of Patenting Examining Procedure, otherwise known as the
Generally speaking, living things are patent eligible. Let me briefly
outline per USPTO policy regarding the patent eligibility of various forms
of living subject matter.
First, animal or plant cells, or human stem cells. In view of Chakrabarty,
the USPTO has applied the same reasoning applied to purified and/or isolated
products of nature to animal and plant cells, including human stem cells.
A naturally occurring animal or plant cell is a composition of matter
and may be eligible for patenting when the inventor describes and claims
it in a purified form. For example, in the form of a cell line or a cell
The purification process is human intervention in nature, and maintaining
the cells in a non-naturally occurring state if a cell culture distinguishes
the cells from the mere product of nature.
Of course, any such claim is subject to other requirements of Title 35,
such as novelty, non-obviousness, and adequate disclosure. For example,
a cell culture of human skin cells said to be useful for skin grafting
may be a manufacturer or a composition of matter eligible for patenting.
However, such an invention must also past the test for novelty, non-obviousness,
and adequate disclosure. Additionally, if human cells are maintained in
cultured, non-natural state, the cultured cell line would be eligible
Genetically engineered animal and plant cells are made by human intervention,
as was Chakrabarty's bacterium. While these kinds of inventions might
be expected to routinely pass the non-naturally occurring test, there
must be evidence that the invented cell is different from nature's handiwork
in some measurable and useful way.
If not the claim is usually rejected and directed to non-statutory subject
matter, as well as for lack of novelty. With respect to animals, plants,
and non-human embryos, for the reasons discussed above, the USPTO issues
patents on non-human animals and plants.
When the invention is the result of human intervention and nature, and
the conditions of Title 35 are met, non-human, animal, and plant embryos
— and for plants an embryo is typically a seed — are eligible for patenting
when the embryo is different from the nature's embryos.
The invented, non-human animal, plant, or embryo, must be distinguishable
from its naturally occurring counterpart.
Human beings and human embryos. MPEP, Section 2105, concludes with this
instruction. If the broadest reasonable interpretation of the claimed
invention as a whole encompasses a human being, then a rejection under
35 U.S.C. 101 must be made indicating that the claimed invention is directed
to non-statutory subject matter.
When a patent claim includes or covers a human being, the USPTO rejects
the claim on the grounds that it is directed to non-statutory subject
matter. When examining a patent application, a patent examiner must construe
the claim presented as broadly as is reasonable in light of the application's
If the examiner determines that a claim is directed to a human being at
any stage of development as a product, the examiner rejects the claims
on the grounds that it includes non-statutory subject matter and provides
the applicant with an explanation.
The examiner will typically advise the applicant that a claim amendment
adding the qualifier, non-human, is needed, pursuant to the instructions
of MPEP 2105.
The MPEP does not expressly address claims directed to a human embryo.
In practice, examiners treat such claims as directed to a human being
and reject the claims as directed to non-statutory subject matter.
The rejection is withdrawn if the inventor amends the claim with the term
non-human to exclude human being. Processes of preparing cell lines and
methods of culturing cells are eligible for patenting because laboratory
processes are not natural phenomena, and involve human intervention in
This also means that laboratory processes or methods for making human
cells and culturing human cells are eligible for patenting. Similarly,
methods of manipulating non-human animal or plant cells to form embryos
are patent eligible.
Cell cultures are used in a variety of ways, including immediately practical
procedures such as surgical intervention. For example, using cultured
cells to treat bur victims.
Methods of using the cells are also eligible for patenting as process
interventions when they provide any practical utility. Thus, cloning procedures
fit in the process invention category, and cloning is eligible for patenting
subject to the conditions of Title 35.
Surgical procedures on human patients are eligible for patenting and can
be directed towards techniques or use of materials such as implants. As
applied to whole animals, the term cloning has several different meanings.
Cloning can occur naturally, such as in identical twins or triplets. Additionally,
there are two quite different artificial laboratory procedures aimed at
duplicating embryos that have been termed cloning.
Blastomere separation and nuclear transplantation. Also known as embryo
splitting, blastomere separation is an artificial cloning procedure that
involves isolating individual cells of very early embryos, and growing
them into separate embryos.
Blastomere separation has been used successfully to increase the pregnancy
rate in cattle. Nuclear transplantation is an artificial cloning technique
that involves removing the nucleus from a cell and inserting the nucleus
into an unfertilized egg from which the nucleus has been removed, an enucleated
The clone cell is then implanted into a surrogate mother and allowed to
grow to term. Somatic nuclear transplantation involves moving the nucleus
from a somatic or adult cell into an unfertilized egg, as opposed to embryonic
cell nuclear transplantation, in which the nucleus is transferred from
an embryonic cell.
Somatic cell cloning is the process that lay persons typically refer to
as cloning, in which an existing animal, adult animal, is cloned. Scientists
in the Unite Kingdom were the first to report a cloned animal by somatic
cell nuclear transportation.
The resulting lamb, named Dolly, is genetically identical to the sheep
from whose cells the donor nucleus was taken. Following the successful
cloning of Dolly the Sheep, many other animal species have been cloned
using nuclear transfer techniques.
These include mice, pigs, cows, monkeys, cats and rabbits. There have
been press reports that some researchers are pursuing human cloning using
Before closing, let me address the possible need for legislation. The
current policy of the USPTO is to consider any claim encompassing a human
being at any stage of development, and not to be patent eligible subject
matter under 35 U.S.C. 101.
Several legal arguments may be used to exclude the patentability of claims
directed to human beings. To date, the court's have not addressed this
question. Legislation may be necessary to ensure that this subject matter
is excluded from patentability.
As was noted earlier, Section 101 of the patent law contains the requirements
that a patentable invention be new and useful, and fall within one of
the statutory categories of process, machine, manufacture, or composition
Canons of statutory construction favor the ordinary meaning of the terms,
and the ordinary meaning for the terms manufacture and composition of
matter does not include a human being. Conferring exclusive rights over
a human being would also raise constitutional questions, and canons of
statutory construction counsel the interpretation that avoids constitutional
In addition, the courts have interpreted the utility requirement to exclude
inventions deemed to be injurious to the well-being, good public policy,
or good morals of society.
In light of the above statutory and judicial constraints, the USPTO has
for 15 years taken the position that it will not issue a claim directed
to a human being or a claim that could be interpreted as being directed
to a human being.
Any actions taken by the USPTO must have legal basis under Title 35 of
the United States Code, as interpreted by the Federal Courts of the United
States. The USPTO also lacks substantive rule making authority.
Legal challenges will therefore likely be raised to the USPTO's interpretation
of statutory subject matter under Section 101. A challenge to the non-patentability
of human beings would be a case of first impression to the court.
The resulting outcome, especially on public policy grounds, is uncertain.
In the Juicy Whip case, the Federal Circuit questioned the continued
viability of the principle that inventions are invalid if they are principally
designed to serve immoral or illegal purposes, noting that this reasoning
has not been applied broadly in recent years.
In addition to the role of the USPTO as a gatekeeper for the public, it
is recognized that strong patent protection has been vital to the development
and commercialization of innovations in biotechnology.
The U.S. biotechnology industry has more than doubled in size since 1993,
with revenues increasing from $8 billion in 1993, to $22.3 billion in
2000. Experience in the biotechnology industry has been that patents in
this area are widely licensed, and are considered to be some of the most
The profitability is largely due to their widespread use and advancement
of biological research. These advances would not have been possible without
broad patent eligibility and the balanced patent system strikes between
generating intellectual property and distributing those ideas.
Despite the benefits afforded by the technological advancements, however,
some technologies are raising profound legal and ethical issues. Until
recently, scientific research had not reached a level that would require
the USPTO to confront claims directed to a human being or methods of making
a human being.
As I discussed that has now changed. Given the uncertain outcome of legal
challenges to the exclusion of humans from patent-eligible subject matter,
legislation may be required to ensure their exclusion.
However, any restrictions that would limit the patent eligibility of biotechnology
inventions must be carefully crafted to avoid unintended consequences,
such as general negative effect on the investment in the biotechnology
Too much restriction could result in the loss of highly respected and
prominent researchers from the U.S. to countries that may provide greater
protection or stronger research advantages.
The USPTO therefore welcomes the guidance and analysis of the President's
Council on bioethics as we attempt to address these issues. I would be
happy to answer any questions that you may have, and would like to assist
the council in answering these questions.
My testimony today has been approved through all appropriate channels.
Please understand, however, that my answers to questions are my own, and
do not necessarily reflect the views of the USPTO or the Administration.
CHAIRMAN KASS: Thank you. Thank you both for very lucid and helpful presentations.
Before I throw the floor open, I would like just to clarify for myself
that I have understood certain matters.
From Professor Kevles, I take it that you would agree that in terms of
the gradual expansion of the terms of patent statutes to allow increasingly
for the patent of living things that as you read the development, you
don't at the moment see any obvious obstacle to the further expansion
of these things to include human materials, even though that has not yet
And particularly that there is a kind of ambiguity about what you mean
by human things.
PROF. KEVLES: That's right. First, it seems to me that the ruling in Ex
Parte Allen still holds, and by the argument of Karen Hauda
here, it has been tacitly accepted by the Congress, because the Congress
has not done anything to contravene it.
Secondly, that applies, and which I think is the understanding, to whole
human beings like us sitting around the table.
Secondly though, it leaves open the question of what is a human being,
and does a human being extend to its parts. We do know, however, that
human genes are patentable, and we have many patents on human genes.
And so it is not the case that all parts of human beings are automatically
excluded, and that is just a fact. It does raise the question therefore
with all due respect as to what the courts might do, no matter what the
patent office policy is, with regard to applications on other parts of
And we do have historical precedent to strongly indicating that the policy
of the patent office has not always prevailed in the patentability of
living subject matter.
The patent office as I have said adamantly resisted the claims of Chakrabarty.
It resisted the claims of Standish Allen, the claims of Hibberd and so on, and those claims were overturned in the first instance by the
Supreme Court of the United States, and in further instances by the Patent
Office's own legal appeals board.
So how this will all work out is not altogether a matter of statutory
— has not been altogether a matter of statutory law, and what is non-statutory
has changed over time. So that is why I conclude that some, I think, clear
clarification of this comparable to the overall of U.S. patent law in
1952 might be in order given the increasing possibilities of engineering
different things that you might call human, or at least parts of human.
CHAIRMAN KASS: Thank you. And for Ms. Hauda, you say that at least the
official policy of the patent office having to do with human things is
answered in terms of the language that this is not statutory subject matter.
The patent office doesn't speak about the 13th Amendment, and that is
not part of the official language. It is the 13th Amendment, for example,
that is the grounds of your restriction.
I mean, the patent claim comes in — the official answer is as you indicated
this is the patent office's interpretation of the statute, and the patent
office has the authority to interpret the statute, and therefore — am
I understanding that correctly?
MS. HAUDA: Yes. Our policy is that we will not issue a claim that includes
within its scope, or is directed to a human being in any stage of development.
That policy is based on statutory interpretation of the Constitution have
been interpreted by the Federal Circuit Courts and the Supreme Court of
the United States.
So in interpreting those, there are for bases for which the USPTO relies
on with respect to that. And why human beings are not patentable, and
that would include the patenting of a human being does raise Constitutional
It also includes that the terms or the composition of matter and manufacturer
do not in their ordinary meaning and parlance include a human being, and
that the utility requirement of Section 101 does raise public policy issue,
and that it cannot be injurious to the well-being and good public policy
of the statute.
And fourthly that for 15 years we have been telling Congress that we will
not patent human beings, and Congress appears to acquiesce to that also.
So we interpret that as part of their interpretation of the statute.
CHAIRMAN KASS: Thank you. The floor is open for general discussion. Rebecca
PROF. DRESSER: Thank you very much for your testimony. It seems to me
that there is a contradiction. I mean, this general view that the Patent
Office decisions are amoral is contradicted by at least the partial invocation
of the 13th Amendment as the basis for not granting a patent on a human
So certainly in interpreting what constitutes a human being, and not just
whether a part constitutes a human being, but what is a genetic human
being. So when is a transgenic creature a hybrid, and how many genes does
it have to have to be a human.
And to me that really requires ethical analysis, and policy analysis,
and sort of substantive analysis, that at least the general view is that
the patent office should not engage in.
On the other hand, I am not that thrilled about having — and I don't
mean any disrespect, but technicians at the patent office making these
kinds of moral decisions. So I guess I don't have a particular view.
But it does seem to me that in this area that there are ethical judgments
being made. So it is touch to square with this amoral label on patent
MS. HAUDA: When an examiner interprets a claim, what they do is the examiners
are instructed to consider what is encompassed within the claimed invention
as broadly as is reasonable in light of what is disclosed in the application.
So when a claim comes in, when read in light of the application disclosure
could read on a human being at any stage of development, the examiner
will make a prima facie case of non-statutory subject matter.
And that is a rebuttable presumption. The applicant can then come in and
argue that its not, and based on the prosecution and the disclosure, and
what the evidence the applicant can provide, is how that examiner makes
So the analysis that the examiner undergoes is very technical based on
what is disclosed in the application and what the scope of the claims
as interpreted under the statute reads on, and it creates a prosecution
history within that case as to what the final interpretation of the claims
And anything the applicant admits to on the record becomes prosecution
estoppel when a court is interpreting the scope of the claims at a future
CHAIRMAN KASS: Professor Kevles.
PROF. KEVLES: First, it was Congressman Kastenmeier who basically argued
that the patent law is amoral and may be implicit in what the patent office
does. But it is my terminology, and so I wouldn't blame it on that.
Secondly though, the phrase, non-statutory subject matter, I think is
problematic. That is exactly how the patent office responded to Chakrabarty's
claim, and we know what happened with that.
Ms. Hauda will correct me if I am mistaken, but I know of no statute ever
passed by the Congress of the United States which says that human beings
are not patentable subject matter or their parts. That's why Congressman
Kastenmeier thought it necessary to enact such a statute in 1989, even
though he failed.
So I think that the foundation here, while it is substantial in terms
of precedent probably, is not statutory in any explicit way. Am I mistaken
MS. HAUDA: No, I agree with your statement that there is no statute that
says human beings are not patentable. However, the USPTO bases its interpretation
of the statute on the case law and the history of what the courts have
And the fact that we were overturned in Chakrabarty indicates that
living matter is patent eligible, but it is our interpretation of the
statute, and based on the 15 years of acquiescence by Congress, and our
direct testimony to Congress, that Congress did not intend the terms of
the statute, manufacture and composition of matter, to include a human
PROF. KEVLES: But it is inferential?
MS. HAUDA: It is interpretative.
CHAIRMAN KASS: Frank Fukuyama and then Mike Gazzaniga.
PROF. FUKUYAMA: Yes. I have a question about Professor Kevles assertion
about the amorality of the statute, because my understanding was that
there actually was language in the statute which I believe Ms. Hauda quoted
that said that the patent office can exclude inventions that are injurious
to the morals of society.
But that as a matter of practice, since the 19th century had actually
not ever tried to exclude anything on that basis. But there is actually
statutory language that would permit that to happen if someone in the
patent office decided to go down that path. That is the first question.
The second question is what would happen
— what would be the U.S. policy if, let's say, a human embryo or some
complete human being, something that is currently not permitted in U.S.
practice was patented in a foreign country, and then that foreign country,
through WIPO or TRIPS, would then try to get that property right recognized
by the United States.
What would be the U.S. policy in a case like that?
PROF. KEVLES: I may be mistaken about that point that Ms. Hauda just testified
to, as to the excludability of patents on inventions that may be injurious
to society is new to me. It is certainly — I was basing my view on the
considerable body of testimony that came out in the Kastenmeier hearings,
and the fact that Congressman Kastenmeier never alluded to this.
I don't know when that phrasing came into the U.S. patent code, and I
am eager to see or to find out more about that. Now, I also recall that
when Jeremy Rifkin, a scientist, proposed to patent a human animal hybrid,
then Commissioner Lehman said that this might be unpatentable on moral
grounds, and then he was widely attacked from the entire patent law community,
saying that there is no statutory grounding for this view.
So I would say that the issue is at the least ambiguous certainly if you
want to pay attention to precedent and the understanding of the larger
body of, or larger community of patent lawyers.
With regard to the — and I am sure that Ms. Hauda will have more to say
about this than I do, but I would just like to observe that the European
patent convention does explicitly include an Article 53A which says that
you cannot get a patent on anything contrary to public or morality, it
has historically not been invoked until recent years, first with the Harvard
And there Harvard University had to jump through a number of hoops to
demonstrate that this Onco-mouse was not contrary to public order or morality.
I would say that the expectation in Europe is that the ethical requirements
of patent law might be imposed through WIPO or TRIPS, rather than our
imposing amorality on the Europeans.
But it is a very interesting issue it seems to me given of course the
globalization of high technology.
CHAIRMAN KASS: Ms. Hauda, did you want to comment in response?
MS. HAUDA: Sure. With respect to your first question, I will just quickly
go through some o the cases that have supported a public policy interpretation
of the statute.
The United States Supreme Court in Morton Salt Company versus G.S.
Suppiger Company, which is 314 U.S. 488, a 1942 case, stated
that the grant to the inventor of a special privilege of a patent monopoly
carries out a public policy adoption by the Constitution and laws of the
United States to promote the progress of science and useful arts by securing
for limited times for inventors the exclusive right to their new and useful
Furthermore, Tol-O-Matic, Inc., v. Proma Product Marketing Gesellschaft,
I think you say, 945 F. 2d 1546, quoted from Lowell v. Lewis,
which is an 1817 case written by Justice Story, stating that the term
useful in Section 101, as used in the patent context, has been construed
to include the connotation that an asserted invention should not be injurious
to the well-being, good policy, or good morals of society.
Public policy takes into account the common sense of the community and
issues that are controversial by nature, and issues that tend to be injurious
to the public or contrary to the public good, and this is the general
definition of public policy from Black's Law Dictionary.
The resulting outcome of the interpretation of the statute under a public
policy reason is indeed uncertain. The Juicy Whip case,
Juicy Whip v. Orange Bang Company, which is 185 F. 3d
1364, indicated that inventions are — that questions of viability
of whether inventions are invalid if they are principally designed to
serve amoral or illegal purposes.
And noted in this holding that has not been applied broadly in recent
years, and that was a 1999 case. So we do agree that the outcome in the
courts is uncertain, but we also believe that there is a public policy
ground that is supported in the case law under the 101 statute.
With respect to your second question on a patent and trying to use TRIPS
or WIPO to move patent rights into the United States, patent rights are
territorial. They give the right to exclude use, import, sale, and manufacturing
of the claim in the patent that was granted.
But they are territorial in right, and so any rights that are granted
in another country can't be imported into the United States and vice-versa.
A U.S. patent that issues, that right doesn't give any rights overseas.
It only gives the right to exclude for use in import and sale, and manufacturing
within the United States.
CHAIRMAN KASS: Thank you. Mike Gazzaniga and Michael Sandel.
DR. GAZZANIGA: Are you aware of the history of why the bill failed in
the Senate in '89, and what the reasonings were or the politics, or whatever
PROF. KEVLES: I think it was — the bill passed the house — I am a little
fuzzy on the chronology, but if I remember correctly, the bill had passed
the house late in 1989. I'm sorry. Yes, I think late in 1989, and then
there was a lot of — it didn't get anywhere in the Senate, and it was
more or less bottled up.
And then there were the elections in 1990, and Congressman Kastenmeier
lost I think in the primary, and was no longer in the Congress to push
it, the new Congress to push it in 1991.
I should add though that the burden of my remarks about the history of
patentability seeks implicitly at least to locate the development of patent
policy and patent law in a larger social economic context.
I don't think you can — this is quite clear in the history of the Diamond
v.Chakrabarty case, and in which it is clear that a subtext of everything
that was going on was first the charge controversy arising from the advent
of recombinant DNA in the mid-1970s, and second the emergence of the biotechnology
industry from recombinant DNA, starting with Genentech and so on at the
end of the 1970s.
And we are familiar with the boom in biotechnology in the '80s and since.
At the time, in the late 1980s, with the end of the Cold War, there was
as you will all remember, considerable attention being given to the competitive
economic position of the United States in the world.
And a major feature of that discussion was the role of high technology
in maintaining and indeed enlarging our country's competitive position
in the world. And this discussion had started in the 1970s, and it involved
computers, and microelectronics, jet aircraft, and now biotechnology.
And if you look at the world trade balance figures, you can see starting
way back that in conventional manufacturers our balance of trade was negative
and decreasing. Whereas, in high technology at the time, it was positive
And so those considerations figured I'm sure in the attitude of the Members
of the Congress and other policy makers, and sort of people in our country
who pay attention to those things.
So there was a strong inclination at the time not to do anything that
would damage the development of this nascent industry, and indeed to do
everything possible to encourage it. You can see strong expressions of
that attitude in the debates going on right there at the end of the '80s
in parallel on the then new human genome project.
And where biotechnology was understood as a product, and would be an important
product of the genome project, and not just information about human genes,
but also the technology that would permit you to sequence them rapidly
and so on.
And this was going to be very important in arming the United States economically
against the Japanese, who were touted at the time to be highly competitive,
and they were about to reduce the cost of every base — sequencing every
base pair to 17 cents when it was a dollar or more, et cetera.
And so the climate at the time was simply adverse to paying serious policy
attention, I think, to these sorts of issues that occupy us today, and
I think that is the larger contextual reason that it just died in the
CHAIRMAN KASS: Michael Sandel.
PROF. SANDEL: Professor Kevles, in your paper you refer to the debate
about patenting human genes, and the controversy over the claims filed
on breast cancer genes as one example. Have the Europeans under their
heading about moral questions, have they rejected or accepted patents
PROF. KEVLES: Yes, they have.
PROF. SANDEL: Which? Have they accepted them?
PROF. KEVLES: They have accepted them, but I should say that in 1988,
and again, at the pending end of the Cold War, the emergence of hi-tech
international economic competitiveness and so on, the Europeans, following
on the exponential growth of the biotech industry in the United States
during the '80s and based in part on Diamond v. Chakrabarty, decided
that they had better do something about — in the community, about their
And so they sought to issue a European Commission, which is the executive
arm of the community, sought to issue a biotechnology directive. There
was a rule in the community that said that you could not get a patent
on things that were the result of the natural biological process, and
I forget all the language right now.
And so what they wanted to do was to lay a solid foundation and intellectual
property rights for biotechnology. It is a measure of the charged nature
of this issue, especially in the European community, that it took 10 years
for them to get this directive issued.
And a number of the objections raised to it that held it up were those
of the type that I have reviewed in my brief remarks, and that I have
reviewed more extensively in the written version that the council has
in its possession.
In the end the — and then gene patenting because or grew into an issue
during this 10 years. In the end the directive was issued in 1998, and
it says that you can't get a patent on anything that impairs or is contrary
to human dignity, including I think human organs.
But I don't want to be held to that. I didn't review that for this purpose
today. But it does say that you can get patents on genes that are of demonstrated
And this is a response to the attempts by Craig Venter, I think, when
he was at NIH, and then later with Celera, or TIGR and Celera, to patent
human genes wholesale on the basis of knowing their expressed sequence
tags, which is just a small fraction of the gene itself.
And without really knowing for sure what the genes do. So it says that
you can get — the European Director says you can get patents on genes.
It does not constrain what the property right is, but it does make more
explicit than might otherwise be the case what you have to know about
the gene in order to get a patent.
PROF. SANDEL: But the patented gene means that you have exclusive property
rights to any use that might be derived from that gene? What does it mean
to patent a gene?
PROF. KEVLES: Well, it means — and Ms. Hauda can expand on that, but
my understanding is that it has a — it means that you have the right
to exclude others from making, using, selling, importing, whatever.
PROF. SANDEL: For any use of that gene?
PROF. KEVLES: For any use, that's correct, including research in the laboratory.
Now, you can forego that, of course, and you can give royalty free licenses
and so on, and say only that you can — that you have to pay royalties
to us or whatever, to company X, if you develop a commercial product out
of this research.
But that is not the way that it has been working in a lot of cases.
CHAIRMAN KASS: Ms. Kass, did you want to comment just on that?
MS. HAUDA: Yes, two things. With respect to the patenting of genes in
the United States, the U.S. patent law also has a utility requirement,
and the mere isolation of a gene won't result in the patenting of the
The use has to have a specific substantial and credible use. And so there
has to be — and so specific means that they need a specific use for it,
and not just a use for further research to study the gene.
A substantial use of the gene means that it has to be a real world use.
It can't just be a fluff type use, and it must be a credible use. So the
utility requirement requires that applicants demonstrate some good use
for their gene before it becomes patentable.
With respect to your second question on the patent rights given in a patent,
the patent is — the exclusive right that is granted in a patent provides
the owner of the patent, or an assignee of the patent, with the right
to exclude others from making, using, offering for sale, selling, or importing
into the United States the patented invention without the authorization
of the right holder.
So with authorization, somebody else could use it. Ownership of the patent
does not provide the owner with the right to make, use, offer for sale,
or sell, or import the claimed invention, because there may be other legal
considerations precluding this.
For example, the existence of another owner with a dominant patent, or
failure to obtain FDA approval for use of the gene, or an injunction by
a court against making the product of the invention, or national security
related issues, for example.
DR. KRAUTHAMMER: Could you give an example of a patented human gene?
MS. HAUDA: Of a patented human gene?
DR. KRAUTHAMMER: Yes, just so we have some idea.
MS. HAUDA: Sure. An example of an actual gene that has been patented?
DR. KRAUTHAMMER: Yes
MS. HAUDA: Well, insulin and numerous cancer genes, such as the melanoma
gene, has been patented.
DR. KRAUTHAMMER: Breast cancer genes?
MS. HAUDA: Yes, Broca-1 and Broca-2.
DR. KRAUTHAMMER: And if you wanted to do research on them, you have to
have it licensed if you are going to even study it?
MS. HAUDA: There is a very narrow research exception, that if you are
researching for non-commercial purposes, that would not be an infringement
under the patent law. But if the research is for commercial purposes,
then yes, you would need to get permission from the right-holder.
DR. KRAUTHAMMER: And if you wanted to develop a therapy different from
the therapy produced by the patent holder, you would have to get a license
from them; is that correct?
MS. HAUDA: Yes. If you want to work with that gene for purposes of commercializing
and looking for a new therapy of that gene, you need to get permission
from the right-holder.
But that is what allows the biotechnology industry to grow, is that relationship
where it is beneficial both to the right-holder to license its gene out
and get some benefit from his invention of what he is taught to use it
So it is not just the isolation. That person has taught a use for that
gene, and the first person to isolate the gene and teach a use for it
is the one that gets the grant to that gene.
Further research that wants to continue to use that gene in order to look
for new therapeutic uses, for example, would need to get permission from
the right-holder, who is the original person who isolated the gene and
found a specific, substantial, and credible use for that gene.
PROF. SANDEL: Thank you.
PROF. KEVLES: I just wanted to ask for clarification on the research exemption.
My understanding is that there is no statutory research exemption, and
that this was an issue in the Kastenmeier hearings in 1987 and 1989.
That there is some common law precedent on specific cases for research
exemptions, but that there is no blanket policy of research exemption
that you can use something that is patented for basic research of a non-commercial
nature; is that correct?
And is that is correct, where does the research exemption on genes come
MS. HAUDA: That is correct. There is no statutory research exemption that
I am aware of, but there is case law that says a research exemption for
non-commercial uses can non-infringement, and just —
PROF. KEVLES: It is not specific to genes?
MS. HAUDA: It is not specific to genes, no.
PROF. KEVLES: So if someone were doing basic research with it on a human
gene, they would be vulnerable to action by the patent-holder, right?
MS. HAUDA: The patent holder certainly could bring an infringement suit,
CHAIRMAN KASS: Robby George, then Janet.
DR. ROWLEY: I am directly related to this.
CHAIRMAN KASS: On this? Okay. Please.
DR. ROWLEY: Because at least in my own experience, and I am not sure whether
Liz could comment as well, if you want to work on a gene or use a technology
that has been developed by someone who owns or holds a patent on that,
you can write for permission to use that and study it.
And you define how you want to use it and study, and then you get or there
is an intellectual property agreement, a material transfer agreement,
that you can sign. And it is signed between institutions. So the lawyers
and the various institutions then will give you permission to work on
But many times those intellectual property transfers also do say in response
to Mike's question that if you find some further use that was not included
in the patent, that use then reverts to the person who made the original
And sometimes these material transfer agreements can take months to achieve,
and it is I think an impediment to free science. And I think that as a
matter of fact there have been comments in Science Magazine and
elsewhere on this very issue.
DR. FOSTER: Just one quick reminder from yesterday when Patricia Baird
talked about the Breast Cancer I and Breast Cancer II gene in Canada,
you will remember that they had an — well, they were required not only
not to test for the gene in their own laboratories, but to send it to
the laboratories of the patent holders for BCRA1 and BCRA2, with a marked
increase in the cost.
Such that apparently Provence has decided that they cannot test women
for this because of the expense.
PROF. KEVLES: I would just add to what Dr. Rowley said, that the situation
is in some cases approaching paralysis, the paralyzing of research, and
that the problem is compounded if the research being done in University
A, which generates patented object or the material object, is supported
by a biotech company, which will then have dibs on what the laboratory
So you can imagine just the material transfer problem of arriving at an
agreement when there is a corporate patron, a researcher in one university,
and then the possibility of exactly the same in a second university.
CHAIRMAN KASS: We have run over. We started late due to a fault of the
headquarters just on the starting time, and we have gone over and we have
Let me ask Robby George, who is on the list, if you want to comment, and
then we will close this and take a break, and take the second panel. Robby,
did you —
DR. GEORGE: I will waive it.
CHAIRMAN KASS: You will waive it? Okay. Since we are running late, let's
keep it sharply to a 15 minute break. The second panel will convene, and
then if our two guests now will stick around or can, we might at the very
end if there is time bring you back and have a discussion with everybody
We will convene in 15 minutes, and thank you very much for the presentations.
(Whereupon, the meeting was recessed at 10:16 a.m., and resumed at 10:36
SESSION 6: REGULATION 4: PATENTABILITY OF HUMAN ORGANISMS 2: ETHICS AND PUBLIC POLICY
CHAIRMAN KASS: Would council members please return so that we can resume
the meeting. We convene for our second session on the patentability of
human organisms. This time is the question of ethics and public policy.
We are very fortunate to have three very well suited members for this
discussion. Steve Holzman is the president and CEO of Infinity Pharmaceuticals.
He was the co-founder and co-chair of the Bioethics Committee of the BIO
organization, and served on our predecessor body, the National Bioethics
Andrew Kimbrell is a public interest attorney interested in these patenting
questions for a long time as the executive director of the International
Center for Technology Assessment, and a more complete biographical sketch
you will find at your place.
And finally Professor Arti Rai, who is a Professor of Law at the University
of Pennsylvania, whose expertise is the area of biotechnology patenting,
and who has provided us with a paper in advance, which I hope that everyone
has had a chance to read.
We will go in the order in which I have just mentioned, and I turn it
over to Steve Holtzman. Thank you all for coming.
MR. HOLTZMAN: Thank you, Chairman Kass, and thank you to members of the
council for letting me speak here. As Leo mentioned, I spent the last
five years attending some 40 plus meetings of the National Bioethics Advisory
I wish you well in the endeavor. I found few things actually as fulfilling
in my entire life as sitting on such a council, and if you take your job
seriously, you can do important things. So, go for it.
I have a power point presentation, and I know that is not considered good
form for a philosophical reflection, but too many years in industry. And
I put it on my company's logo more than anything else not to advertise,
but rather that I am up here speaking as Steve Holzman. I am not here
speaking as the designated representative of the biotechnology industry.
There is probably some overlap of how I think the industry thinks, and
traditionally the industry finds me a little odd in how I think, but that
makes it consistent with the rest of the world. So here we go.
Leon called me up and said he wanted me to talk about three questions.
The first was the impact in a narrow sense on the biotech industry if
we prohibited patents on either or both processes of making isolated human
embryos, or on claims covering the isolated human embryos themselves.
The second issue was to think in terms of the broader impact on biotech
if we were to establish a class of biological methods and/or entities
as prohibited subject matter under the patent system.
And the third, time allowing to provide some ethical reflections on the
social meaning of allowing or prohibiting such patents. And he didn't
answer this, but it got me thinking about the role of bioethics councils.
So I want to start with three definitions. I am not saying that these
are the right definitions. I am saying that for the purposes of this talk
and a series of reflections, these are what I mean.
First off, by a human embryo, I mean a biological entity, which all things
being, if you plant it in a woman's uterus and leave it there for nine
months, the result is a human child.
I actually think that is a very useful and ethical debate, and just call
a spade a spade, as opposed to starting to get into counting angels on
So that is what is in play in this discussion. It's regardless of whether
you achieve the diploid nucleus by in vivo or in vitro,
by intercourse, by IVF, SCNT. I don't really care, okay? And it is regardless
of whether you are talking about a zigo, to pre-or-post neural streak,
or blastocyst, et cetera.
I am putting them all in the same bucket for the purposes of this discussion.
The second definition is a research purpose embryo, because I think that
is really where the nub of the debate is.
And I mean an embryo created without a reproductive intent, but rather
with the goal of using it, hence destroying it, in biomedical research
In those terms, a spare embryo left over from a reproductive effort, if
used as is, is not a research purpose embryo. However, a spare embryo
in which SCNT is performed, creates a new embryo which may or may not
be a research purpose embryo, depending on whether or not you put it back
in the uterus or you destroy it. Finally — I'm sorry?
DR. GEORGE: I wonder if I could interrupt. I just did not understand
that point. A second embryo is created from a spare embryo?
MR. HOLTZMAN: I think that is an important point. There is the problem
with saying that we get around the problem of research purpose embryos
by simply using spare embryos left over in IVF clinics when the reproductive
project is finished.
When you then do SCNT on it, you effectively create a new embryo with
the intent of destroying it and using it in research.
DR. GEORGE: So do we then have two embryos?
MR. HOLTZMAN: No, you have one. The first one ceases to exist.
DR. GEORGE: Leon, do you understand this?
CHAIRMAN KASS: I think so.
MR. HOLTZMAN: It may be that it is not that important for this discussion.
CHAIRMAN KASS: Let it go.
MR. HOLTZMAN: Okay. The third is to get some clarity on what is a patent
right, and this is a definition which is not must mine. It is the right
to prevent others as you have heard absent a license from making, using,
importing, selling, or distributing the patent invention.
Hence, it is not a positive right. It is not a tangible property right.
It does not block new patents. If I have a patent on fire engines, and
you come along and notice this tall building and create a fire engine
with extension ladders, you can get a patent on fire engines with extension
ladders. Patents don't block patents.
And then with respect to the basic research exemption, which is not in
the statute, it does exist in common law in the case of Roche v. Bolar by implication, where effectively the court found that there is no such
thing as basic research in a for profit entity.
Conversely, there is such a thing as basic research outside of the scope
of patent prosecution in non-profit entities. And pragmatically there
is a basic research objection, because businesses don't go about suing
universities unless and until the universities start acting as competitive
To the point that was raised by Dr. Rowley and Dan when he was up here
about the problem of MTAs and what not. There has been a lot of work done
on this, and there are significant issues.
I served on Varmus' working group that came forward with a report on how
we might better deal with it, which was largely ignored. I am currently
serving on the National Academy of Sciences Council or working group coming
forth with a report in the next few weeks on what we should do in the
case of access to research materials that are published.
So if the council is going to get into that issue, there is a rich history
there. There are issues. I actually don't think they are essentially about
patents by the way. I think they are about contractual rights pertaining
to transfers of material.
Anyway, so question one, what is the impact narrowly on biotech industry
if we prohibit either or both of these kinds of patents on processes,
of making, or on the human embryos themselves.
So let's get a conceptual picture of what we are talking about. You start
with the starting material, and there is a process-A, and it gives you
a product-A, and the product-A itself can be the subject of further processes
to give you further products.
And let's give an example of what might be in play here. So the starting
material, it was oocyte, right? And so process-A might be a method of
making an embryo especially suited for generating universal donor cells
and multiple cell types of for transplantation.
Wherein, the method compromises, you add genes X, Y, and Z, and so that
they can go on to immortalizing culture, and you delete Genes A, B, and
C because those remove the MHC complex in order to make them universal
So the Product-A would be the embryo would be the embryo that resulted
from such a process. And then what would you do with it? Well, you would
do further processes to make particular universal cell lines; for cardiac,
kidney, neuron, et cetera, and then Product B would be those kinds of
What is the relevant current policy as it stands right now? The process
claims are all allowable. The human product claims are not allowable by
policy, and as you have heard in the case of In Re: Allen,
Quigg, from the USPTO, came forward with the statement that a claim
directed to or including within its scope a human being will not be considered
to be patentable subject matter.
And again as came up in the last session the key question is what is a
human being. Do you mean a person, the kinds of things sitting around
this table who are subjects of rights and responsibilities? Do you mean
persons and embryos?
Do you mean persons and embryos in human cells? So what is patentable
in the scheme I just gave you looks like this. All of the processes, currently
those downstream products, the cells, and the Product-A, wherein that
is the embryo, that is a little bit unclear, though pragmatically the
way that it is playing out is that they are not being patentable.
And that is the de facto situation. They are not being granted. It's claimed
to follow from Quigg, but actually it really doesn't follow from Quigg
whatsoever, and I will talk about that in a bit. And the reason that they
aren't the de facto situation, and this is my analysis, is that it just
was not an issue up until recently, number one.
And then, number two, now that it is, it is a political hot potato, and
the USPTO is good to duck its head and just not issue the claims. But
what are the practical implications of the current situation?
To understand it from a business perspective, you have to know one more
piece of patent law, and it is 35 USC 271.G. And that is that it shall
be an act of infringement to import, sell, or use within the U.S. a product
which is made by a process patented in the U.S. if such action occurs
during the term of such process patent.
In other words, a patent holder on Process-A can block or receive just
compensation on the sale or use of products B, B prime, et cetera, if
he can show that the competitor used a Product A made by Process A, even
if the competitor did not practice Process A.
CHAIRMAN KASS: Would you do that again?
MR. HOLTZMAN: Okay. Take a moment and read it, and I will go back to the
schema. Under 271G, if I have a patent on Process-A, I have the right
to prevent others from importing, using, or selling Product A, okay?
So if you think that you have a commercial product that you care about
are those Products B Prime through B Triple Prime, the sell lines, if
I can show that someone has used Product A in making it, I have got them
on an infringement under 271G, okay?
You wanted me to answer the narrow question and I am getting at it. This
is it. So if you say the council recommends that there is no patents on
the methods of making the human embryos, no Process-A claims, I would
submit that it would significantly reduce, if not eliminate, incentive
to private investment in the development of Product A, there is no protection.
If research to develop methods to produce A is privately funded, you would
be a fool to publish it, and you would also be a foot to let Product A
out and make it broadly available.
On the other hand, if you leave intact the process claims, but you say
there shouldn't be any product claims, no human embryo claims, what the
industry will effectively do is operate as it does now. You rely on that
It is not as strong and compelling when you are trying to raise funds,
and a lot of this is about young companies trying to raise funds, and
it does fall on you that the burden of proof to show that when someone
uses Product A, that in fact Product A was produced by Process A.
Another interesting issue that you will have to deal with is what is it
when — what about when the university, for example, practices Process
A to make the embryo and then transfers it to someone else. Who do you
And then there is the temporal concern. Someone practices the method,
the protected method of making the embryo before your patent is actually
issued, and then someone uses the product after the patent is issued.
They are outside of the scope of being able to go after them. So the bottom
line conclusions, if there is no Process A and if there is no patents
available in this area in either methods of making embryos, or embryos
of themselves, you won't get early stage investment, and you won't get
private investment in early stem cell research.
But if that is your goal, go for it. You will have to rely on the public
sector to research and develop the products of Product A type, and concentrating
private investment in the process downstream of making the actual cell
lines. An interesting situation when we don't have Federal funding for
making the embryos in the first place.
On the other hand, if you leave intact the Process A patents and say we
don't want embryo patents, the Product A patents, industry investment
and early stage stem cell research will continue relying on 271G protection,
but it will be moderated exactly as it is now.
So, question two, the broader impact on the biotech industry of establishing
a class of biological methods and/or entities as prohibited subject matter
under the patent system. So you have already heard this.
In the United States, the criteria of patentability are four-fold; novelty,
not obvious, utility, and enablement. In Europe, you have heard the situation
is different, but I think there is a distinction that I think people fail
to make in the last sentence.
There is a fifth criterion; the invention must not be contrary to public
order. That is, it must conform to mortality. But Article 53A is not relevant
to a category of subject matter as such, but rather to the use of particular
It doesn't say, for example, that animal patents are not allowed. It rather
says that you can make a distinction between the Onco-Mouse, a mouse whose
utility lies in a system for developing cancer drugs, and hence is allowable
under the fifth criterion.
But they can judge not patentable the transgenic mouse who glows blue
in the dark and is therefore a designer fluorescent mouse because that
is considered to be contrary to morality. It is an important distinction
between what you are discussing here is whether there ought to be a law
that goes to removing categories of subject matter.
You do not have a precedent for that in 53A. You have an otherwise where
they have eliminated, for example, in certain countries patents on plant
varieties and what not in species.
In terms of international trade, the U.S. in general has been a strong
supporter of patent protection, particular in biotech. The U.K. has already
issued claims covering human embryos, and you heard reference earlier
to the TRIPS aspects of the WTO agreement.
It does allow countries to exclude from patent protections classes of
technologies, but only if the development and use of the technology is
prohibited in the country. That is an only if, and not an if, okay?
And no provision — there is no provision for exclusion of patent protection
in the absence of the prohibition of use. So in other words, if you were
to recommend no patents on the technology, I would suggest to be in conformance
with this that you had better be recommending that the technology not
Now, what about the role of morality and utility in the United States?
We have heard some discussion, and let's be clear that there is nothing
in the 35 U.S.C. 101 of what is patentable that makes any reference to
It is all about case law, and I would submit to you that there is now
a well evolved tradition that patents are value neutral. That in this
country, we regulate the use of inventions, and not the issuance of patents.
The case from 1817 or whatever that was referenced was about the definition
actually of a specific utility being sufficient. There was a tradition
in the 1900s as manifested in the Reliance case up there that effectively
— that if something is injurious, it lacks utility, and it was the doctrine
of what is called beneficial utility.
But there has been a long tradition of cases throughout this century,
and Fuller versus Berger, I think, says it very well, that utility
cannot be negativized by the mere fact that the thing in question is sometimes
injurious to morals, or to health, or to good order.
It would be fatal to patents for many of the noblest inventions of the
19th century, and the previous speaker mentioned the Juicy Whip case recently, where the invention effectively enabled one to defraud,
but it was held to be patentable.
So when we think about how this has swung over and the broad issue in
biotechnology, there have been a series of cases — let's see, I put up
four of them up there, three of which you have heard about, which have
raised the morality issue.
And they are Chakrabarty v. Allen, which was the oyster case, where
it was actually decided that crier organisms were not inherently unpatentable,
and then the Leder mouse, and the Onco-Mouse.
The Quigg statement was in connection with Allen. We didn't mention
by the way Pasteur, some hundred years before Chakrabarty got a patent on an organism, which always strikes me as very interesting.
So when we look at reactions to these cases, which leads to talking about
bans on biological inventions, or can be read as such, I didn't have time
to research whether or not there was a public outcry when Pasteur got
his patent on baker's yeast.
But certainly in reaction to Chakrabarty, we get statements such as the
World Council of Churches, a statement that the U.S. Supreme Court on
patenting life forms rested upon a specific and highly reductive conception
of life, which sought to remove any distinction between living and non-living
The Chairman of this Council made the statement, and I hate to take things
out of context, but that Chakrabarty teaches that a living organism
is no more than a composition of matter, and no different than the latest
perfume or insecticide.
And then in response to Allen and Leder, we had Rifkin saying
that the PTO has decided organisms are indistinguishable from electric
toasters and automobiles.
One can take these as statements suggesting there ought to be a ban on
such inventions. What are some of the beneficial results of not overreacting
and not banning that we have seen in the past? Well, in Chakrabarty,
it is the intellectual property basis for the recombinant DNA-based biotechnology
industrial revolution, which has produced over 120 drugs to date.
I submit to you that would have been bad overreaction. In the case of
Allen and Leder — and I should say that I am intimately
familiar with this, because I founded the first transgenic animal company,
and I was the person testifying on Capitol Hill in '88 about animal patents.
Transgenic animals, whether it be by gene- addition or knockout, are the
single most powerful tool we have for understanding gene function today,
and understanding the role of dysfunctional genes in disease initiation
and progression, which is the whole basis of a new kind of medicine that
will actually hope to prevent and cure, as opposed to merely palliate
And furthermore the prospect of transgenic animals that are a source of
important medicines and treatments would not exist, and those medicines
are things that can only be produced through those animals, such as certain
proteins, antibodies, and organs for transplantation.
So the bottom line is from the industry's perspective, of my view of the
industry's perspective, is to talk about banning a set of or subject matter
as patentable is a precedent setting Pandora's Box which we so not want
to open because we do not believe it is controllable.
And we are put in the unfortunate situation of what I call the how long
has it been since you stopped beating your wife problem, and assigned
by culture. So you believe that we should have a patent law that views
human embryos as morally equivalent to toast and perfumes, and answer
yes or no.
But that is the situation, and so we are forced to duck and weave on this
one, but we have deep concerns that I just have tried to articulate. The
third question was ethical reflection on the social meaning of allow or
prohibiting patents on human embryos, and for my two cents in the role
of bioethics councils in such debates.
The first thing is that patents — you know, you just listen to the dialogue
around the table a few minutes ago, patents are — somehow when we talk
biology — as bad things, bad things, patents. But in fact patents have
a very noble history.
They are enshrined in the Constitution, not merely in legislation, all
right? And I am going to give you a moment to read this, because it is
one of my favor pieces of writing by Jefferson, because it really goes
to the heart of what is a patent and why we have them.
Because inventions, that is, creative ideas, cannot be the subject of
tangible property rights, and that we want people to share them. And his
image of the taper is so beautiful because in doing so they are not diminished.
However, as a society to encourage that sharing, the creation and dissemination
of knowledge, we want to ensure that there is a proper incentive system
for doing so. All right.
Now, that ties interestingly when you think about that to the question
that has come up also is can nature be patentable. And you heard people
say, yes, nature is not patentable, or referring, for example, to the
Tungsten case, which I think is from the early 20th century.
But it is very, very, clear — and I think this is the best statement
I have ever been able to find of it in Merck versus Olenr, that
nature is patentable if that which is natural which you are seeking to
patent meets the criteria of novel, non-obvious, a utility, and enabled.
The particular case here had to do with Vitamin D-12, and other cases
in this realm as we mentioned was the prostaglandins. That you isolate
so that the logical form of the patent claim is that you present something
that doesn't exist on its face and nature, but you isolate it.
And again as the court points out in Merck, all of the tangible things
with which man deals, and for which patent protection is granted, are
products of nature.
And I think here we need to start doing some philosophy, and make some
key distinction. The first is that a patent right is not a property ownership
right in the physical embodiment. The patent right is the right to prevent
others, that is, from profiting from the invention by making or using,
selling or distributing, embodiments of the invention.
In a moment, I am going to ask you to think here about copyrights, and
patents, and just for the moment assume that they are equal. This is a
disk, and I own this disk that I am holding, all right? I can play it.
I cannot copy the sympathy. I cannot resell copies of the sympathy.
If any of you are authors of books on which you have copyrights, the question
came up about whether or not if you are the patent holder on BRCA1, you
have the right to prevent others from using it if in fact it would be
cheaper for them to do so.
If you are a copyright holder on a book and I can't afford your book,
but I could afford to go down to a copy shop and copy it so I could read
it, you have a right of enforcement against me.
The second is that the physical substance is not the invention. It is
not the patentable subject matter, and it is not the idea; the physical
substances, the embodiment of the invention.
It makes sense to say I am holding in my hand Shostakovitch's Fifth,
but when I drop it and break it, the symphony is not destroyed, all right?
So if you keep that in mind, the basis of the patent system of granting
intellectual property rights is two-fold.
One is a natural product rights orientation, in terms of getting the fruits
of one's labor. They are not able to be protected like tangible property.
I can't put a fence around it like I can put on land. And then in the
utilitarian concept, there is a public interest in sharing the ideas,
and we want to reward the inventor and encourage the dissemination.
So with that as a backdrop, I want to suggest to you that there is enormous
wisdom in Quigg in response to Allen, and it is no what
you have heard articulated today here by the patent office, or perhaps
even by Quigg himself.
He wrote that a claim directed to or including within its scope a human
being will not be considered to be patentable subject matter. That is
not a moral argument, and it is not about being contrary to public policy
pace what we heard from the USPTO.
And for that matter, neither a human invention or a patent on it would
directly contravene the 13th Amendment. Rather, I think what we have in
front of us here is what Wittgenstein would call a piece of philosophical
grammar; an elucidation of the concept of a patent, and it goes something
It makes no logical sense to grant an intellectual property right, consisting
of the right to prevent others from making, using, or selling embodiments
of your invention, if it is in the nature of all such embodiments of your
invention that they cannot be the object of a tangible property right
to begin with.
In other words, being able to be owned is the precondition of one having
a right over the embodiment so as to be within one's rights to make, use,
or sell it.
So is there a gap in the law? In Leon's invitation to me, he wrote we
seek to discover whether there is a gap in the present law that would
allow for the patenting of a living human organism, and if so, whether
it should be closed?
I would suggest to you that there is absolutely no gap in the logic of
the law. An invention could be patented only if the living human organism,
which is its embodiment, can be the subject of a property right.
And so what we are faced here with is thinking through this thorny set
of issues, and I don't pretend that what I presented to you is necessarily
easy to follow.
Leon is very — with wisdom, has written of the wisdom of repugnance and
the role of bioethics councils, and in the background papers that were
prepared for this council beforehand, there was good attention paid to
the fact that it can be a visceral response to repugnance.
But it is the role of such councils to elucidate the roots of the repugnance,
because otherwise we could find ourselves prohibiting miscegenation, for
example, at a certain time in history.
And what we need to do here, and what you need to do, and I hope that
we all do, is provide a non-sound bite discourse that enables us as a
people to get it right, and to make those key distinctions, and to debate
the right issues.
I think there are great examples of this in predecessor councils. I think
the President's Council in Splicing Life in 1981, at a time when there
was visceral repugnance to the notion of genetically engineered human
beings, and eugenic concerns, came forward with what is now an obvious
distinction between somatic and germline gene therapy.
And drew the important similarities of somatic gene therapy and currently
accepted medical practices. When I transplant an organ, I do a gene therapy
of 40,000 genes, for example, somatically.
And that the key eugenic concerns are only in play in germline cases,
and that allows progress on one front, and with deep social reflection
and deliberation on the other.
And similarly the last council NBAC I think contributed to that in the
cloning debate, and again an obvious distinction now between reproductive
and non-reproductive cloning, and in stem cells by calling attention to
what it believed to be the moral legitimacy of supporting Federal funding
for using, but not generating, ES cells.
So what does that mean for you? Focus on the real questions. This is really
what is in play. We are undergoing a revolution in biology which is as
profound as the Copernican revolution; not only scientifically, but in
terms of our understanding of ourselves and our relationship to nature.
And it forces us to ask questions about can we maintain an attitude of
reverence; that is, taking something in its perfection consistent with
an engineering perception or prospective. That is, that we are going to
And then focus on just allowing ownership and inter alia patenting, and
focus on the ownership of human embryos, and does that fundamentally and
irrevocably commit us down a path of reductionism and an overwhelming
materialistic view of life.
You might in that sense start to investigate our attitudes to the human,
and here are some various human parts and organisms. Think about how differently
you feel about these things, and how we as a society stand in relationship
Deeply interesting to me is, for example, you cannot sell blood. You can
only donate blood in this country. On the other hand, you can see plasma.
Why is that?
And I would submit to you that most of us at first blush think of oocytes
very, very differently than sperm, and how we think they ought to be regulated
apart from issues having to do with the safety of the woman from getting
the superovulatory regime.
Broaden the range of cases of reflection when you think about research
for purpose embryos, because not all research purpose embryos have the
same social meanings.
Every time in these debates every one has in play the notion of the —
of what would happen to our views of reproduction in the family if we
allow the creation of embryos for the purpose of destroying them.
But go read U.S. Patent 4,987,080, called, "The Method of In Vitro
Maturation of Oocytes." There is an invention and it doesn't work
very well, in which, for example, if a woman has an ovary removed because
it has a cystic condition, you can keep it alive in culture, and it will
produce oocytes for you.
There is no mother, and there is no father in play, and there is no reproductive
project in play. If I take one of those oocytes out of that machine, and
IVF it, or SCNT it, and then go on and do experimentation, do you feel
the same repugnance. Do you feel in the same ways that what you are imagining
is your paradigm case when you thought of repugnance in research purpose
Don't get caught on the one-sided diet of examples. So I would submit
to you that you will do yourself and the public a disservice to get sidetracked
on to the patent issue unless you use it to confront the real issue, which
is the creation, ownership, and use of research purpose embryos, and to
do so in all its richness.
And once you have done that, and if you conclude in your wisdom that you
should recommend that there ought be no creation, ownership, and use of
such things, then your conclusions will follow logically into the patent
system, and there will be no patents on such things.
I would oppose you, but I would feel that you were being consistent. Thank
CHAIRMAN KASS: Thank you very much. The second presentation by Andrew
MR. KIMBRELL: Thank you, Dr. Kass, and I want to thank the council for
inviting me this morning for I think a long overdue discussion. You know,
when I was first working with Senator Hatfield to set up the first Bioethics
Advisory Committee, the very first thing they were supposed to look at
was patents, and they never got to that.
And so I think it is quite extraordinary, and I personally appreciate
it very much, not just for inviting me, but that we are talking about
this subject this morning this morning.
I would like to do three things with my talk. The first is to try and
give you an idea of where I think we are on this issue. The second is,
and this actually feeds very nicely off of Steve's presentation, the second
thing is to try and provide more or larger bioethical context about the
human body, and some of the issues that surround that.
And the third is some suggestions, at least from my part as an attorney,
on where I think we might go with this and some of the precedence that
you might look at to try and resolve some of these admittedly extremely
And that is even before somebody brought in the ideas of Wittgenstein.
First of all, I think I differ from the previous speakers in telling you
that I think that we are way past the line that others have talked about.
Just a few weeks ago — and by the way, we will be providing the council
with two papers that Peter DeMauro of my patent watch program, and Doug
Hunt, of my human genetics program, will be providing the council.
And so we will have all of this in writing with footnotes for you. First
of all, we believe that the patent office, in patent 6,311,429, has actually
already allowed the patenting of embryos, fetuses, and actually borne
This was a patent that was granted in April of 2001 for the process essentially
of the cloning of mammals, the cloning that you have all heard about.
And both the patent holders and the attorneys involved believed exactly
as Steve was saying, that 35 U.S.C. 71G extended that process to all products
thereof, specifically claimed by the patent holders and into the subsequent
media uproar, and the attorneys admitted that though they had no intention
of using it, that the scope did go that far.
Subsequently, we have discovered yet another patent, which I will provide
you, that is a patent on germ line modification. This is genetic engineering
germ line modification of mammals, and once again you heard Karen Hauda
say that we are very, very careful to use that word non-human before all
In both of these patents, the word non-human is not there, and the University
of Missouri patent that is on cloning, and on human clones, the word human
is there. So the idea that the patent office has consistently used non-human
when it is granting patents on mammals or on cloning, or on germ line
genetic engineering of mammals, is not the case.
It did not happen in April of 2001, and it did not happen in April of
2002, and there is numerous pending patents that we have identified and
that we can provide you that again specifically asks for the patenting
of human embryos, fetuses, and in certain cases the extension into borne
So the urgency of the discussion today isn't something theoretical, or
that we are afraid that we are going to extend In Re: Allen further, that extension has already happened. That extension has already
happened with granted patents.
And if you have been listening to the debate on the floor, when a bill
is introduced in the Senate just last week to try and forbid the patenting
of embryos, and fetuses, you will have heard Senator Kennedy and Hatch
say that they do not oppose the patenting of embryos and fetuses.
They believe that kind of patenting is important for research. In that
regard, let me clarify something that was discussed earlier. I was lobbying
on the Hill trying to support the Patent Reform Act of 1989.
That was subsequent to the In Re: Allen decision that you
have heard about that allowed for the patenting of animals. We are trying
to get a research exemption in that bill both for researchers and for
farmers, and so they would not have to pay patent fees on animals.
At that point, Henry Hyde, who was on the subcommittee, asked Bob Kastenmeier,
well, what about humans, and what about human organisms in all phases
of development, and Bob Kastenmeier said I don't know.
So Henry Hyde asked the patent office at that time are embryos and potentially
fetuses patentable. The patent office said, yes, they are. That is why
Henry Hyde put that amendment into the 1989 Patent Reform Act.
And the reason that the patent office gave at that time — and I was glad
to hear today that they seemed to have changed that to some extent, but
this shows you how mutable this is at the patent office; is the reason
that you cannot patent persons was because of the 13th Amendment considerations
in the Constitution, and therefore, human life forms that were not considered
persons, were patentable, because they would not face that same Constitutional
Let me add by tue way, that if you look at what has happened since In
Re: Allen, that is, the decision that allowed for the patenting
of animals, that there are literally hundreds of animal species that have
now been patented, and a significant percentage of those animals have
human fetal organs, including brains, pituitary glands, virtually every
fetal organ, implanted in them.
And this includes several patents which we will provide you that talk
about the patenting of 36 week old fetal tissue in mammals that range
from mice through beagles.
Now, I may not be necessarily able to talk about the delicacies of Wittgensteinian
embodiment, but I can tell you that we have patents currently for 36 week
old fetal organs in animals, from mice to beagles, and we have already
allowed through our patents on cloning and our patents on germline modification,
the patenting of human embryos, fetuses, and even borne children.
So that is the situation from our point of view that you are facing today
when you look at this issue, when you look at how we are to treat this
And I thought that once given that perspective of where we are, and what
is actually happening, I personally would call that both an ethical and
legal free fall, not only at the patent office, but also in Congress,
that should have been overseeing this since 1980.
Note that there has been no legislation since the Chakrabarty decision
that allowed the patenting of a microbe. The patent office extended that
to plants in '85, and to animals in '87, and to human genes, organs, animals
containing human organs, and now to cloned and modified human embryos,
fetuses, and borne children from a microbe.
And I ask you today — it was a 5 to 4 decision in Chakrabarty,
a very narrow decision, and most people thought it would go the other
way, but do you really think that it still would have been a 5 to 4 decision
if instead of an oil eating microbe, which is what they were looking at
patenting in 1980, if they were looking at cloned human beings or fetuses
with human fetal brains, or rather mice with fetal brains, and beagles
with fetal brains, and do you really think that would still have been
a 5 to 4 decision to allow the patenting of life.
Having said that, I do agree with Steve on a couple of things, and I am
glad that he explained the extension of 271G, because then I didn't have
to, and it is a hard thing to explain, and I think he did an excellent
job at that.
I do agree with Steve that we have to look at this in the larger context
of what I would call the engineering and comodification of life. This
is not an isolated incident. You know, so often — and I am guilty of
this a lot, but we tend to look at these biotechnology issues and other
issues with kind of a technological amnesia.
We kind of forget the historical basis, and so very briefly, because I
don't want to overextend the time, I do think it is important to — or
at least from my perspective, that we look at the context.
The issue of the comodification of the human body — really, the first
case that I know of and that I have been able to document, was really
in 1962, and it had to do with the sale of blood.
Many doctors, and doctor organizations, refused to take blood that was
from people — it was sold blood. It was commercialized blood. Instead,
they were only taking blood that was donated. Several commercial blood
banks sued these doctors, saying that blood is a commodity, and by discriminating
against us because we are using blood that is sold, you are essentially
interfering with our trade, and they went before the Federal Trade Commission.
They won that case, and went to an appellate court, which said that blood
is indeed a commodity and indistinguishable from other commodities, and
can be sold.
And contrary to what Steve said, blood is still sold in this country,
and it is sold internationally. It is a multi-billion dollar a year industry.
However, Congress did step in and made sure that there was special protection
for donated blood.
The same issue came up when technology was able to develop just the transfusion
technology and led to this controversy over blood, because blood suddenly
became valuable, and we began to learn how to transplant organs.
So, not surprisingly, organs because very valuable, and as many of us
remember, for many, many years, all the way through to the early '80s,
there was advertisements in the local newspapers for corneas, for kidneys,
for you name it. Organs were for sale as they remain in many countries
around the world.
It wasn't until the Organ Transplant Act of 1984, one of the first things
that I was involved with when I came into Washington, that we were actually
able to get Congress to agree that organs, as far as transplantation,
should not be a commodity. They should not be treated as a mere commodity.
Unfortunately, organs still can be sold for research, and Congress sort
of cut that deal. Subsequent to that, we had the whole issue of fetal
tissue, and can fetal tissue be a commodity. Can that be sold.
Well, for many years it was, and some would argue that it still is. At
least in 1988, as part of the Public Health Act, we were able to pass
a law for baby open sale of fetal tissue. However, fetal tissue is still
sold under the guise of fees, access fees, and as I said before is patented.
The next major controversy that at least I was involved in, involved surrogate
motherhood. Can you sell motherhood. Can you sell the baby that results
from that. Again, our nation is sort of split on that, and you have got
16 States that have forbidden surrogate motherhood as the illegal sale
of a child and gestation.
And as the infertility industry develops, sperm and eggs have become very
valuable. Most States allow their sale as commodities. Many of them have
And then finally with the advances in genetic engineering, we arrive at
this table today on what do we do with human genes, stem cells, and now
embryos, fetuses, and perhaps even borne children.
How far will we allow the extension of the market, the extension of our
economic life, into the body proper. How far will we let engineering principles
into the human body, and what is at stake if we do that.
So this is obviously a thumbnail sketch and our paper will go into more
detail, but I did want you to be able to see — some may call it a slippery
slope, and some may say we are just skiing downhill.
But I did want you to see both — not just from Chakrabarty, but
with these concepts of the commercialization and the engineering of the
human body that this is certainly a continuation of a longer discussion.
Let me read you a couple of things about the potential implications of
this. I was asked to be a speaker at the 16th International Congress of
Genetics, and I was especially taken by the keynote address of Dr. Robert
Haynes, a very respected geneticist.
And I would like to read you from his keynote address. "For 3,000
years at least a majority of people have considered that human beings
were special, were magic. It is the Judeo-Christian view of man. What
the ability to manipulate and patent genes should indicate to people is
the very deep extent to which we are biological machines."
"The traditional view is both on the foundation that life is sacred.
Well, not anymore. It is no longer possible to live by the idea that there
is something special or unique, even sacred, about living organisms."
And that was his keynote speech. Much of my work in those years was working
with the World Council of Churches, and Steve actually put up one of the
things that I wrote for the World Council of Churches up there on the
implications of patenting and comodification on our concept of the human
Virtually every religious tradition has had a very different view, and
the Office of Technology Assessment, which I was an advisor at that time,
had this to say about the ownership and sale of the human body.
"Virtually all religious traditions offer insights about the value
and significance of the human body. For them, the human body is created
in the image of god, and therefore, there are limits on what human beings
can do with their own bodies, and those of others. There are limits on
what can be sold."
Now, we get a lot of religious groups to sign on to that, and a lot of
people just from the ethical communities as well, and published an ad
in the New York Times, and Senator Mark Hatfield joined in that.
The Times answered us in an lead editorial, called "Life Industrialized." And I would like to read you from the New York Times about — and
this was specifically about the patenting of animals and potentially human
genes and organs, and we hadn't even gotten to the embryos and fetuses.
The editorial said, "Life is special, and humans even more so. But
biological machines are still machines. They can now be altered, cloned,
and patented. The consequences will be profound, but taken a step at a
time, they can be managed."
And that is the lead editorial in the New York Times about the
patenting of life. "Biological machines are still machines. They
can now be altered, cloned, and patented."
So I would maintain that there is a very concrete philosophical issue,
and not an easy one certainly, that we are dealing with in this whole
history of comodification, and now specifically including all life, and
specifically human life forms, under Section 101 of the Patent Act.
And that is exactly what we as a community, and we as a polity, what our
view of the human body should be. And what I would suggest to you — you
know, Chesterton once said that Christianity was not found wanting, but
rather found too difficult, and therefore never tried.
What I would suggest to you is despite all the failings in much of our
Judeo-Christian culture, and those of many other faith traditions, they
have an extraordinary image of the human body, which is the very basis
for the rights that we have in our Constitution.
And the basis for such prohibitions on torture that we have and slavery,
and these are the basic efforts that inform our rights, and I would ask
you what rights in here to a patented industrial machine manufacturer
or composition of matter, and what dignity inheres to that.
I can't help but see Dr. May over here, and he had one of the most marvelous
quotes that I have heard in a long time, and he said, you know, if you
sell the Nobel Prize, you undermine what that would mean. You take all
the value out of it.
If you were to sell the Congressional Medal of Honor, it would have no
value. If you sell children, you undermine the dignity of what it means
to be a human being. What I would suggest to you, all legalisms aside,
is that when you patent under Section 101 of the Patent Act, embryos and
fetuses in human beings, you have in a very profound sense undermined
the dignity, integrity, of what it means to be a human being.
I would like to conclude by putting sort of more of a legal view on this,
and disagreeing again with some of the previous speakers on this. I do
not see how it is possible, and I don't believe reading the law that it
is possible to suggest that our government should interfere in a free
market system by granting a monopoly, which is essentially what a patent
Without some consideration as to the usefulness, and therefore the public
interest being served by that interference in the market. For almost every
technology we are taking, the patent office is the first port of call.
It is the first policy decision where government appropriations are used
to either support or not support a particular technology or invention.
And the court's have consistently said that usefulness cannot and should
not be conceived as a requirement of patents without infusing in that
usefulness whether this — and you have heard the quotes from a number
of cases, and I have one as recently as 1964, that says public interests
and public morals should be part, and need to be part, of the usefulness
review, and it has been in Europe.
And in that regard let me read you actually what has gone on in Europe,
which is that you have heard about Article 53, but no one so far has mentioned
the biotechnology directive of 1998, which was adopted by the EPO.
And Article 6 of this directive contains a number of categories of areas
where patents are not allowed currently, and that includes human persons
at any stage of development. That includes human cloning, in all of its
And that includes human germ-line manipulation, as well as the creation
of human and animal chimeras, as currently their directive. So we would
not — this country would not be cutting new legal ground, and should
create the same categories as non-patentable.
Nor if we were to do so, it would be to put ourselves in an uncompetitive
situation, at least with our European counterparts, because they had already
done so. Further, I think that it is important, and I have it here somewhere,
that we take a look at the international agreements that we are part of,
to see whether any ban or prohibition on these processes again of human
cloning, and the germ-line modification, and the uses of human embryos,
whether if with all forms of human life forms, if we were to ban patenting
on those, would that in any way put us into conflict with our international
obligations under TRIPS, and I read for you, "Members may exclude
from patentability" — and this is TRIPS, The Trade-Related Aspects
of Intellectual Property Rights, 1994, part of the General Agreement on
Trades and Tariffs.
"Members may exclude from patentability inventions, the prevention
within their territory, the commercial exploitation of which is necessary
to protect "ordre public" or morality, including to protect
human life or health."
Furthermore, let me read you from NAFTA, the North American Free Trade
Agreement, Article 1709.2, provides that a party may exclude from patentability
inventions if preventing in his country the commercial exploitation of
the invention necessary to protect "ordre public" or morality,
including protection of human life or health.
And these are agreements that we have legislatively approved, and again
already on the books. Again, we would be cutting no new legal ground should
we comport our domestic patent law to those. Well, how should we do that,
and what can the patent office do.
And Ms. Hauda's plea for legislation is certainly one that I feel, and
we certainly feel that the current legislation pending at least, while
not perfect, would be important.
But it is certainly within the Patent Office's purview to set up a subject
matter advisory committee that would review the usefulness requirement
of patents and terms as the Europeans do, and many of our other trade
partners, in terms of ethics.
Now, the problem with a subject matter advisory committee is that it has
the unfortunate acronym of SMAC, but it would be an enormously useful
tool that would comport and harmonize us with our trade partners.
And what they would be able to do is that i would recommend that they
do exactly what the Europeans have done; set up several categories which
are unpatentable, and again all forms of human cloning, all human life
forms, germline genetic modification, certain kinds of human and animal
chimeras, and those are the categories that I would recommend setting
I am sure that many others will have others, or recommend that some of
those not be included. Additionally, they would set up requirements as
far as publication, for instance, in the Federal Register, of patents
that might — for instance, any patent that claims human material would
be published in the Federal Register for comment.
That doesn't mean that the patent necessarily would not be allowed, but
it means at least there would be a full public review of it. This should
be done at an advisory committee level, and that way the examiners will
not have to remember to put in non-human.
You will not have as we have seen two patents granted by examiners which
actually include a human. This advisory committee would come in and the
series would be promulgated, and therefore the examiners would not have
to make these ethical decisions on their own.
I would like to conclude by making just one quick comment, because whenever
I have spoken about this, inevitably people say the only problem with
this is that we need to cure disease, and we need to come up with new
And Steve just said something, very, very similar, and very well. Let
me say that before 1987 that we made extraordinary advances in medicine
without deciding that we had to patent animals and fetal organs in animals.
Until the last 10 years or so, we made extraordinary advances in medicine
without needing to patent embryos, stem cells, genes, and now fetuses,
and perhaps even borne children.
If a researcher out there who is going to cure AIDS, and who can patent
the process, can patent the medication, can patent surgical techniques
used, will get world renowned for curing the disease, if that is not enough
incentive for that researcher to actually cure that disease, both financial
And if he says also that I need to patent the mouse I am working with,
or I need to patent the genes I am working with, I would suggest that
that person is in the wrong profession, and that they should leave medicine
and make a living on the stock market floor.
Our medicine has survived beautifully without this kind of patenting,
which I do not believe has anything to do with actual creation of new
medicines. It is not necessary for that. This is simply with the corporate
enclosure of the human body, which is as I have suggested leaves us into
a comodification mechanism of the human body which undermines our fundamental
values. Thank you.
CHAIRMAN KASS: Thank you very much. Professor Rai.
PROF. RAI: Okay. I have been told that I need to wait until it counts
down. We now have lift-off, I guess. I also wanted to thank Dr. and Professor
Kass for inviting me to address this very august group, and I have been
asked to speak on the very specific question of whether a change in the
patent law is necessary as an ethical matter, or is a constitution matter
to address the patenting of human organisms.
Before I comment on that question, I just want to clarify a couple of
things. The first is that I do think that I seriously disagree with Mr.
Kimbrell's suggestion that patents on human organisms or product patents
on human organisms have been granted, and I think the 271G issue is a
lot more complicated than what he has suggested.
But in any event, the other thing that I want to clarify is the types
of entities to which I am referring when I use the term human organism,
there is a lot of potential for confusion, and misunderstanding obviously,
and I need to focus on organisms that are already either full persons,
like all of us standing around here or sitting around here, or are like
embryos and fetuses capable of becoming full persons.
I probably need to encompass within my use of the term primeras that would
have a plausible claim to Homo Sapien status, but I think that
issue is a bit of a red herring, because if we start creating those kinds
of human, we are going to have a lot more problems than simply patenting.
We are going to have to then determine how to interpret our Constitution
as an initial matter, and so I think that is probably something that is
perhaps even beyond the scope of this panel to — well not beyond the
scope, but certainly other bodies would be interested in how the Constitution
would apply to those chimeras.
I don't mean to include parts of humans. In other words, I don't mean
to include organs, or more relevantly for this discussion, genes, I think.
With respect to genetic information the law is clear, and I think there
is really no going back, and as an economic matter, they probably should
be no going back.
As Professor Holtzman mentioned, the National Academy of Sciences is doing
a very extensive study on whether the scope of patents on genetic information
may be too large and as a consequence may be inhibiting medical progress
as a consequentialist matter, and I think that is the real issue, is it
inhibiting medical progress.
But that is something that the National Academy of Sciences is looking
into, and actually the Federal Trade Commission and the Department of
Justice are also taking a look into that problem.
So in any event, as Dr. Holtzman suggested, there are a lot of other agencies
in town interested in that question. Okay. So back to the question that
I was asked to look at, which is, is a change to the patent law needed,
and the short answer in my estimation is probably not. Why not?
For three reasons, which I will just summarize briefly and then I will
proceed to explicate in a little more detail. First, it would appear that
much of the current concern about patenting human organisms of various
sorts is really grounded in ethical concerns about the underlying activities
that produce such organisms.
So depending on the group involved, this may involve opposition to reproductive
cloning, or to therapeutic cloning, to pathogenesis, or what have you.
In my estimation, it would be a serious mistake to use the patent law
as an instrument of wide-ranging moral regulation.
As you probably already know, there is no constitutional impediment to
Congress regulating the underlying activities directly, and in fact there
are lots of bills in Congress to regulate those underlying activities
And so obviously Congress has shown no hesitation in looking at such legislation
that would directly look at activities like cloning or what have you.
And I am not suggesting anything substantive on what we should do with
respect to that regulation, but the patent law is the wrong place to look
in my estimation. And in fact there may even be a Constitutional problem,
which I would be happy to get into in the Q&A, with using the patent
power that Congress has to import morality judgments, general morality
Second, even to the extent that one is comfortable with the underlying
activity, and let's assume that one is comfortable with the underlying
activity and let's say therapeutic cloning, but is concerned with the
comodification, and that word has been used a lot already, the comodification
of the products of the activities, the patent law is still not the place
As a general matter, patents advance comodification much less than do
other types of property rights, and in particular rights in tangible property.
So, for example, when Congress choice to limit the comodification of organs
in the context of organ transplantation, it wisely chose if you believe
in the limitation of comodification, to limit tangible property rights
in those organs.
It didn't go and modify the patent statute, and insofar as I know, one
could patent a new and non-obvious organ if one chose to. It seems to
me that the single situation in which patents on human organisms may raise
ethical concerns that do specifically involve the patent law, is the case
which is far from reaching thus far, where patent applications have claims
that cover fully developed human beings, as I will talk about persons
within the meaning the of the Constitution.
And in that case though, I think the PTO does have the authority to reject
those applications as raising serious Constitutional issues under both
the 13th Amendment and the 14th Amendment.
Okay. So let me turn to the first issue, and I am going to go quickly
through this one because I think that some of these, that some of the
prior speakers have touched upon this issue, which is if we are concerned
about the ethics of the underlying activities, then patent law is not
the place to look.
And historically unfortunately when people have been concerned about the
ethics of the underling activity, they have tended to look to the patent
law because often times patents reveal what companies are up to well before
the company itself is willing to come forward with that information.
So, for example, the heated debate in the 1980s over the transgenic mouse,
known as the Harvard Onco-Mouse, was really spearheaded by groups that
were opposed to the creation of transgenic higher life.
Earlier on, the patenting debate that surrounded the Supreme Court's 1980
decision in Diamond versus Chakrabarty, which you have heard
a large amount about, was in fact spearheaded by groups that opposed the
creation of any sort of recombinant life.
So the underlying activity was what they were really seeking to target.
Similarly, it seems to me here that the current debate about patenting
is a bit of a sideshow. What we are really concerned about, or the groups
that are concerned about patenting, are really concerned about is the
ethics of creating those organisms through cloning or other artificial
means in the first instance.
Now, as the Supreme Court recognized in Diamond versus Chakrabarty was that regulating scientific research, and the morality of scientific
research through the mechanisms of the patent law, is a very misguided
First of all, at least some scientists will engage in the research independent
of whether the possibility of patents exist. Sociologists of science have
long observed that scientists seek prestige and honor, at least as much
as they do money. So they will continue to engage in the activity.
And in addition, and perhaps more importantly, pecuniary rewards can accrue
through mechanisms other than patents, and most obviously trade secrecy
is a mechanism that is often used, particularly for protecting processes.
Process patents can be very weak, and oftentimes biotech companies just
keep processes as trade secrets. And in addition to being the first to
market with a particular invention is also a time honored mechanism for
securing pecuniary rewards.
So to the extent that we are concerned about the ethical horribles that
may result from a particular technology, we should just regulate that
It seems to me, therefore, that it is not surprising that the patent statute,
the language of the patent statute. as has been mentioned, contains no
suggestion that Congress intended to import general morality judgment
into the patentability determination.
There is nothing in the language as Dr. Holtzman has mentioned, and as
I have discussed, in fact it may be it seems to me, that it would be troubling
as a constitutional matter for Congress to enact a patent statute that
did have something to morality judgments, because its authority under
the copyright and patent clause of the Constitution that Dr. Holtzman
has already shown us, is limited to authorizing patents and copyrights
for the purpose of promoting the progress of science in the useful arts.
And that terminology has not been read to encompass morality concerns.
It has been read to encompass purely utilitarian concerns. Now, there
has historically as has been mentioned existed within the American patent
law, particularly in the 19th Century, a purely judge-made doctrine known
as moral utility, and a few decisions from the 19th century in particular
relied upon that doctrine.
But it seems to me that the Federal Circuit has made it pretty clear that
that doctrine, if it isn't dead, it is pretty much dying. And most patent
scholars, I think, would assume these days that even devices that were
made for illegal purposes, and therefore could not be used under some
other law, could be patentable.
And as several people have mentioned, because the patent right doesn't
confer any affirmative right of use, one can have a patent on something
and still be barred from using it. So those are two very distinct issues.
And let just talk briefly about the European experience that some of the
other speakers have already alluded to. It seems to me that the experience
of countries that have more robust morality requirements within their
patent system really underscores the problems that arise when one tries
to import general morality judgments into patentability.
For example as has been mentioned, Article 52(a) of the European Patent
Convention, provides that patents shall not be granted for, "inventions
of publication or exploitation of which would be contrary to ordre public
Well, the patent examiners who examined the Harvard Onco-Mouse patent
application in Europe had to deal with 53(a). They were forced to deal
with 53(a) by an appeals board; that they initially didn't want to deal
with it, and then the appeals board told them that they had to deal with
And so they determined that in order to figure out what 53(a) meant with
respect to the Harvard Onco-Mouse, they would have to determine first
the utility of the invention to mankind in remedying, quote, widespread
and dangerous diseases. Second, the possibility of cruelty to animals;
and third, the possibility of uncontrolled release of unwanted genes into
Well, patent examiners are scientists who are hired for the purpose of
examining patents on technical grounds, such as novelty, lack of obviousness,
and adequacy of disclosure. They don't have any training in ethical issues,
or for that matter in making judgments about environment risks, and I
would be very concerned if patent examiners were called upon to do that.
Now, concerns about comodification. Some would argue or perhaps agree
with me that the right to patent law should not be modified to address
generalized ethical concerns about scientific research, but perhaps reform
would be appropriate for specific concerns regarding comodification.
In other words, we might be concerned that the research products that
are the subject of patents could be sold and bought like ordinary property.
So to give this example again, we might be comfortable with therapeutic
cloning as an ethical matter, and in fact even endorse it, but oppose
treating the human embryo product of that therapeutic cloning as ordinary
property that can be bought and sold at will.
Here even it seems to me that when patents fall short of claiming full
human beings, it is not clear why we should be focusing our comodification
worries on patents. In fact, whether patents are allowed or disallowed
it seems to me affects comodification levels very indirectly at best.
The patent grant confers on its holder simply the right to exclude others
from making, using, offering, or for sale, or selling the invention. It
doesn't confer any affirmative right to use the invention.
So as I mentioned several times now, if we were to allow patents on a
particular invention, we could still prohibit selling or otherwise trafficking
in the invention, and it seems to me that is precisely the situation we
are in with respect to human organs and transplantation.
I don't see any impediment to patents on human organs, but there is a
significant legal impediment to trafficking in human organs. Transversely,
the decision to ban patents on particular inventions doesn't eliminate
Absent other Federal or State laws, individuals can still sell and buy
human organisms as tangible property, and that is the real property right
that one has to keep in mind. It is not at all addressed by the patent
Now, there is one context where patents on human organisms could raise
patent specific concerns, and this is the context that is far from arising
currently, but it is worth keeping in mind.
If product patents were granted on full human beings, and not just human
embryos, and not fetuses, but full human beings, these patents might give
the patent owner the power to interfere quick significantly with the autonomy
of the fully developed human being.
And this is because under the patent law the patentee's power to exclude,
quote, others, from using the invention wold presumably encompass the
power to restrict the patented being, himself or herself, from "using
himself or herself."
So as a consequence the patentee might have the authority to forbid the
patented being from seeking employment, or perhaps engaging in any type
In addition, because the patent statute also allows the patent owner to
prohibit "others" from making the patented invention, the patentee
might have control over the patented beings' reproduction, and such severe
limitations of autonomy obviously would represent a serious ethical concern
that is specific I might add to the patent statute.
Well, this is where the Constitution comes in. It seems to me that ethical
concerns about the patenting of full human beings could be addressed through
the Constitution and specifically the 13th and 14th Amendments.
The 13th Amendment, as many of you probably know, bans not only slavery,
but also what is known as involuntary servitude. And it seems to me that
a patent on a human people could be deemed to impose an involuntary servitude.
Now, the 13th Amendment, juris prudence, involuntary servitude, has needless
to say focused on cases where there has been a physical or legal compulsion
to work. So it has focused on cases involving bondage, and peonage of
But it seems to me that property rights that entirely disallow an individual
from choosing his or her employment, or choosing to work in the first
place, could fall within the scope of the amendment.
In addition, the patentee's control of the patented beings' right to reproduce
it seems to me might implicate the protections of the 14th Amendment.
The 14th Amendment protects reproductive decision making, and there is
a — well, lawyers would immediately point out, well, where is the State
It seems to me that the State action here is provided by the fact that
the patent is a right explicitly granted by the State. So the 13th and
14th Amendments provides the best justification for the PTO's current
policy to the extent that it disallows product patents on full human beings.
Now, some commentators in the legal literature have argued that the PTO
doesn't have the authority to make those Constitutions calls. That only
courts have the authority to make this Constitutional call. I think that
this argument is quite mistaken.
Obviously the PTO doesn't have the ultimate authority on any Constitutional
question, but as has been mentioned by some of the previous speakers,
there is a canon of statutory interpretation that the PTO can and should
And in fact the Supreme Court has suggested that agencies do employ when
interpreting statutes, which is try to interpret them so that your interpretation
doesn't raise serious Constitutional concerns.
And the Supreme Court has consistently struck down agency interpretations
that raise serious Constitutional concerns. Now, of course, an agency
can't do that where the statute is really clear and says you must grant
patents on human beings, full human beings.
But here the statute doesn't say that. It is at least arguably ambiguous
on the question of full human being and it seems to me that under the
avoidance canon here could usefully be invoked by the PTO to say that
we are not going to grant patents that raise serious Constitutional questions.
And it seems to me that courts would view this issue very seriously or
similarly, and they would probably view product patents on full human
beings as being a serious tension to the Constitution.
A court would have two options. They could either use the statutory interpretation
mechanism, or because they are Article 3 courts, they could just directly
declare such product patents to be an unconstitutional application of
the patent statute.
Now, it is important to emphasize that these Constitutional arguments,
and I repeat do not, apply to patents claiming human organisms that have
not been born, such as embryos or fetuses.
The Supreme Court has explicitly stated that a fetus is not considered
a person within the meaning of the constitution and if a person is not
considered a person, it is unlikely that an embryo would be.
Consequently, under current law there is no Constitutional bar to patents
with claims that are strictly limited to human embryos or fetuses. So
to the extent that the PTO's current policy denies patents on human embryos
or fetuses, it probably lacks Constitutional justification.
But if we are concerned about protecting the interests of human embryos
and fetuses, and there might be a good reason to be so concerned, we can
urge Congress to pass legislation directly addressing those interests.
And as I have noted earlier Congress has pretty much plenary authority
under the Commerce Clause power to address these general ethical concerns,
as well as more specific concerns about comodification.
So in conclusion, it seems to me that the issue of patenting is almost
in all respects really quite orthogonal, that is, at right angles, to
ethical debates on research involving the creation and manipulation of
It would be a serious mistake to modify the patent statute in response
to concerns about research that are not patent specific. And the isolated
circumstance where a human organism or research does raise ethical concerns
that specifically implicate the patent system, and that is the case of
a product patent on a full human being, these ethical concerns it seems
to me can be addressed through the Constitution. Thank you very much.
CHAIRMAN KASS: Thank you very much. Michael, did you want to raise a question?
I thought you were leaning forward. I guess I would like to invite the
participants in the first panel to join us at the table.
While they are joining us, let me start with a question to Professor Rai.
You say that the patent protection does not confer any affirmative right
on the use or upon the patentee. But it does so in the absence of a bar,
is that not correct?
PROF. RAI: Yes, in the absence of some. In general, in human action, that's
CHAIRMAN KASS: But it is not simply the exclusion of others from access
to this and use of this. But it is generally for the sake of one's own
use of this; is that not correct?
PROF. RAI: That is correct.
CHAIRMAN KASS: Is this not then an encouragement, as least the encouragement,
of use? I am sure that people could get patents for things they have no
interest in developing, but in the context we are speaking, the awarding
of the patent in the absence of a bar gives governmental and premature
an encouragement by granting such a patent?
PROF. RAI: Yes.
CHAIRMAN KASS: And isn't it true that while the decision to ban patents
wouldn't necessarily eliminate comodification as you say, there the law
would simply be silent; whereas, the granting of the patent is in fact
an encouragement to the comodification, an official encouragement; is
PROF. RAI: I suppose, because I think of patents as rights of exclusion
rather than rights of use. I don't see them as affirmative, other than
in a purely symbolic way affirmative encouragement.
CHAIRMAN KASS: But the purpose of the patents is in fact to encourage
development use as you yourself said?
PROF. RAI: Right. But I think it is a modification.
CHAIRMAN KASS: It is technically a right of exclusion. It is a right of
exclusion for the sake of encouragement of the use.
PROF. RAI: Yes, but when I use the term comodification, I am thinking of
sale and purchase of items in a market system, which I don't think a patent
necessarily — it doesn't necessarily set up a system where you are going
to have exchanges of items.
CHAIRMAN KASS: But in the context in which we are speaking now, the commercial
interest in developing a patent has nothing to do with the buying an selling
of the possible products of these patents?
PROF. RAI: Oh, of course it does, but it seems to me in a much more direct
way. I am not suggesting that if you resist into comodification that patents
won't help your cause a little bit.
But it seems to me that given that the patent law is really not designed
to deal with moral issues, that is really not the way to do it. And in
fact I do think that Congress would have a serious Constitutional problem
on its hands if it said that pursuant to our authority under the copyright
and patent clause, we are going to ban certain categories of matter from
I think it would have a serious problem on its hands, because the clause
does talk about using copyrights and patents to promote the progress of
science in the useful arts.
CHAIRMAN KASS: And there is also the preamble to that Constitution, and
it also doesn't say that — it says that in order to promote progress
in science that Congress shall,but it doesn't say that the only reason
that it shall is governed by that. There is a preamble that governs the
entire Constitution in the service of which that is.
And let me agree with the general conclusion. I personally don't think
that the patent office is the right place to deal with moral questions.
I don't. But in order to make that point, it doesn't seem to me that you
have to deny the role of patenting in the comodification of things that
come before the patent office.
And also that what you call symbolic, that symbolic things are in fact
crucial to questions, if not of autonomy, but to questions of dignity,
self-perception, the kind of community that we are.
And therefore I want to grant some of the large points. I don't think
the patent place is the right place to do this. But to write a kind of
brief which says that there is really nothing at stake in this, there
is nothing sort of morally and culturally at stake in this, seems to me
PROF. RAI: Oh, I think there is a huge amount at stake. I don't think that
the best way to address this, and as I have said many times, is the best
way to address it is through the patent system, and we
CHAIRMAN KASS: And we agree.
PROF. RAI: Yes. But I think with respect to the general comodification
issue that there is a huge amount at stake, yes.
CHAIRMAN KASS: Michael Sandel.
PROF. SANDEL: I don't have a view on whether the patent law is the best
way of getting at comodification issues, and I think that by the way that
all three of these presentations have been fascinating, and I hope that
their papers that are lying behind them or closely connected so that we
can have access to them so we can pour over them at greater leisure.
But as thinking about a project, or an agenda for this council on these
kinds of issues, it seems to me that this is a crucial area. And the question
is how do describe, how to focus, the discussion and the inquiry if we
take this up as a project.
I don't know that patent law as such would be the best way to define that,
but it seems to me the broader issue, and all the speakers have addressed
this one way or another, is the comodification of life, or of life forms.
And that it seems to me is not only of enormous interest and ethical importance,
but also for public policy now, and especially in the area of bioethics.
And I would suggest that we not restrict this inquiry in terms of the
subject matter to embryos, or genes, or organs, but leave open the range
of application, and address broadly speaking the comodification of life,
or of life forms, insofar as it bears on bioethical questions.
There was some discussion that Mr. Kimbrell brought up of the scientists
account, the mechanistic account, the human body as a biological machine.
And I don't think it is true that as a philosophical matter that it is
incompatible to view human life under two descriptions.
One under the description of sanctity and dignity, and the other under
the description of a mechanistic account. Philosophically, you can have
both descriptions, but the important question for us is, is that as a
matter of social practice, what social practices, and what forms of buying
and selling, and patenting, will crowd out or undermine the self-understandings
and the social practices associated with a certain human picture.
I don't think that we can say, though I sympathize with a lot of the points
that Mr. Kimbrell — a lot of the things that he objects to, I also object
to, but I don't think we can just take for granted the comodification
as such destroys the value of a thing.
It does in the case of a Nobel Prize by definition, because if it is bought,
it is not an honor. But there are other cases where that is not true.
For example, buying kidneys. The kidney might work perfectly well as a
kidney, and the kidney is not destroyed by the buying of it, but yet it
is a further moral question whether we want to commodify kidneys.
And then there are intermediate cases between the Nobel Prize on the one
hand and the kidney on the other, and these are the really interesting
and difficult questions.
For example, a market in children or babies for adoption. Well, you might
argue that — some would argue that the child is still a child, and whom
you can love, and cherish, and bring up, and others would argue that the
market in and of itself would gradually erode the understanding and social
practices associated with children and child rearing, and the relation
between the two.
But in any case, I think this should be the focus, the issue, to what
extent does the comodification of life or life forms run the risk now
under present circumstances of eroding a certain picture of human life,
and the practices associated with it.
And then specifically what bioethics public policies do we need to consider
as a result, and then leave open for the moment whether it is patent law
that we need to address, or direct legislation, or some other thing.
CHAIRMAN KASS: Thank you. Paul HcHugh, Robby George, Elizabeth, Gil, and
DR. MCHUGH: I just want to both underline what Michael said, but also
add a certain sense of the combination of the combination of presentations
we have heard.
We have heard today that patent law isn't the way to do things, and that
might be right. I don't know. But we have also heard that this is a copernican
revolution in our world, and by the way our experience here in the council
as we have talked about the meanings of these new biologies do make us
all think that this is a copernican revolution.
It is certainly a big revolution how we understand what cells are capable
of, and what is built into the human genome, and therefore what we could
do about it. I just want to emphasize the fact that if this is truly a
copernican revolution, then we should revolutionize the way that we are
thinking about what our policies are, and what our laws are intended to
I mean, the fact that our laws have been suitable up until this time in
managing through patent methods the things that you say might or might
not be suitable for the next era that we are entering.
We are entering an entirely new era that the constitution, as somebody
said, is not a suicide pact. We can do things to change it, and we should
it seems to me given what we have been discussing here today.
CHAIRMAN KASS: Robby. By the way, I want to make sure that we also leave
some time for further comments either from our guests or one another,
and to respond to things that are said.
DR. GEORGE: Leon, my questions are going to be on a different line,
and so if people want to respond to Paul's, they probably should now before
I distract them
CHAIRMAN KASS: Why don't you put it in.
DR. BLACKBURN: In his testimony, Kimbrell ended with an implied plea
for medical science to return to perhaps business as usual as it were
before the 1980s, and then he cited his reason for this the extraordinary
advances in medical sciences.
And while true to some degree, I think we have to be reminded that in
fact while we have had those medical advances, we are still left with
a somewhat erroneous impression as to where this set of advances has gotten
And in a large number of quite prevalent diseases, we have not gotten
very far, and in a way that you could say that all the easy ones have
been done, and the ones that have been left are the ones that are complex
and often very prevalent human diseases.
And that's why I think that the chAllenge that they are presenting
now does argue alone the lines that Paul was saying, although for somewhat
different reasons, and I think we do have to go beyond businesses, and
I think we have to be very open to thinking about going business as usual,
because we have got a lot of very chAllenging and intractable,
currently intractable, medical problems that still lie ahead of us.
CHAIRMAN KASS: Perhaps this would be a time to get any of the five who
would like to comment, but particularly the second panel to either of
MR. KIMBRELL: Yes, I would like to agree that obviously there is a larger
focus than patenting, but patenting is still a very legitimate focus.
It is an extraordinary policy decision made by our government.
As far as being an appropriate place for morality, almost 200 years of
legal precedent say that it is an important place, and they expect the
utility requirement in patent law to be one that includes the public interest
and includes an ethical consideration.
The European Patent Office believes that it is the right place, and TRIPS
believes it is the right place, and NAFTA agrees that it is the right
So I think for those legal precedents behind us, I think it is very important
to say maybe it is the right place. As far as it being an incentive, which
indeed it is for industry, and for science, or for science and the useful
arts, I also don't happen to think that science and the useful arts are
I believe that science has to be moral, and that the useful arts and industry
has to be moral. I don't believe that by just using those terms that you
have entered an amoral realm in that regard. One other thing is that as
far as Professor Rai is concerned, I am no more comfortable with the examiners
being ethical or ethical examiners on patents as I am on being constitutional
lawyer as far as deciding what is constitutional or not.
So I disagree with her suggestion that we can leave that to the examiners
to decide what is constitutional. I have not suggested that. I think legislation
is appropriate, and I think whatever is done at the patent office should
not be done at the examiner level as I said, but with an advisory committee
that matches those of our European partners and others that takes a look
at these issues.
CHAIRMAN KASS: Do you want to respond directly to that, because I think
Professor Kevles does on a general point?
PROF. RAI: Yes, I do actually. I don't think anyone would suggest that
the PTO should be the final judge of what is constitutional. Everything
that the PTO does can and should be reviewed by courts, and certainly
any denial of a patent application on a full human being, the product
of a patent application on a full human being.
I think the first thing that would happen is that we would go right to
the Federal Circuit and the Federal Circuit would have to face the constitutional
And it would do so and obviously evaluate the question without any deference
to what the PTO had said, but the way that our system works is that sometimes
you go through an administrative agency first, and the Supreme Court has
suggested that the administrative agency should at least consider constitution
questions when it goes through the interpretative process.
It is not the final arbiter by any means, but it can take those into consideration,
those questions into consideration.
CHAIRMAN KASS: Professor Kevles.
PROF. KEVLES: Just a few points briefly. One is that I want to endorse
as strongly as I can what Professor Rai has said about the patent as a
kind of surrogate issue for what really concerns people, and the endorsement
arises again from what I know how to do best, which is an historical analysis.
Namely, if you look at when the patent issue arose, it arose just after
the recombinant DNA debates. And the issue of whether we should be engaged
in genetic engineering of higher organisms or not, including the possibility
of human beings, and the revival of a kind of eugenics, and all those
issues were prominently raised in the '70s.
And people lost. The dissidents lost because genetic engineering then
proceeded,and it was demonstrated as safe, et cetera, and we know the
rest of the story. And it is just after then that Chakrabarty came
up and the issue and that people began to focus on patents.
And the patents even then seemed to strike me historically as the emergence
of a surrogate issue for what is really of concern. Secondly, we ought
to focus on what is really of concern, and partly of what was of concern
And here I want to I think endorse what Professor Sandel said, and that
is by pointing out to you the huge consequences that can arise from the
absence of patents. And again the historical case would be hybrid corn,
and hybrid chickens.
Those were devised as technical means of not producing better corn and
better chickens, and this is in the '20s and '30s, but also as ways of
protecting intellectual property rights on the part of the breeders in
the absence of patent protection.
And that rights are protected because the parental generations, their
genetic composition if you will, is known only to those who devise them.
That is, the companies, like Pioneer Hybrid in the case of hybrid corn.
And the farmers are compelled to buy the seed from those generations,
and if the farmer seeks to harvest the seed and plant it for the next
generation, he regenerates. So they are forced to go back to the companies,
and this is long before Monsanto gets into the business, half a century
And I am not quarreling with this as a system. I developed, and it worked,
and has produced profits, and produced higher productivity in agriculture,
and in the corn business, the chicken business, and other areas.
But what I think we have to bear in mind is that there is no simple solution
to these things, and that these things have to be addressed in a rather
And, for example, if one could imagine that in the absence of patent protection,
of say human embryos, which right now don't enjoy the status and protections
of personhood, that there could be universities and/or corporations that
would devise certain forms of human embryos, that would fall within the
trade secret area, and there could be a market in them which would make
us I think no less unhappy than we would be if we had a blatant patent
on one of these things.
CHAIRMAN KASS: Steven Holtzman.
MR. HOLTZMAN: I want to fully endorse the inquiry that Michael is suggesting,
because that is the inquiry, and I think talking about things being symbolic
as I said to you on the phone and in my slide, it is about the meaning
of these social practices.
And with the revolution in biology, the whole way we come to understand
ourselves and how we stand in relation to each other, ourselves, and nature,
gets changed, or at least gets challenged. Let's put it that way, and
the social practices we adopt affect who we are in the society that we
decide to make, and that is the question in front of us.
What I would encourage the council and with all due respect, I find focusing
our patents spitting out the sound bytes, and distorting what was in the
University of Missouri claims, and distorting what is in TRIPS, to make
more sound bytes, it just doesn't contribute to an enlightened dialogue
that will get us beyond where we stand today and have stood for the last
And so I would encourage that we get down and we talk about do we want
embryos to be bought and sold, and if so, under what conditions, under
what kinds of regulations, and what are the implications of that for children.
Think through the broad range of cases. I would submit to you hat when
you think of an embryo, we have a different picture of an embryo, just
as we have a different picture of a family, that corresponds to 20, 30,
50 years ago, and what it is today.
It is not saying that today is right, and maybe what we want to do is
try to go backwards, and we have to confront those facts, as opposed to
flipping out just sound bytes.
MR. KIMBRELL: I certainly don't think that part of that dialogue should
be ad hominem attacks, and I certainly don't think that anything
that I said was meant to be a sound byte, and the University of Missouri
and the patent attorneys who did that admitted that it did and was intended
MR. HOLTZMAN: There was no product claim in it, and —
(Simultaneous conversation, inaudible.)
MR. KIMBRELL: Second of all, I think that the biotechnology could be viewed
as a side issue. The vast majority, and I think it is very important to
examine the actual live patents that have been granted.
The vast majority are not on generically engineered organs. The vast majority
of plants have not been genetically engineered that have been patented.
The vast majority of animals that have been patented have not been genetically
engineered, and they are not products of recombinant DNA technology.
The vast majority of genes have not been genetically, Even the stem cells
that have been patented — up to this point, many of them have not been
genetically engineered. The vast majority of life forms have been patented
since Chakrabarty are not products of recombinant DNA technology.
So I think when you are looking at this patenting issue, I totally agree
that it is not synonymous with the biotechnology industry and it should
not be viewed as a vote on biotechnology. It should be viewed as a very
important ethical question on whether we want to legally define life within
Section 101 definitions.
It is not just a legal issue. It is an ethical issue, and I think a very
worthy one, and as the stakes get higher and higher, a critical one for
this group. And I think to ignore this issue may be convenient, but I
think it is going to lead to problems, extremely difficult ethical problems
in the future.
CHAIRMAN KASS: Robby George and then Gil.
DR. GEORGE: I wanted to explore a little bit with Professor Rai the
constitutional question, the one area in which you were suggesting that
we have an exception and the question of patenting could raise constitutional
And I am curious at getting at the details of why that should be, and
then why only that should be, and at the heart of it I think is the distinction
that you are drawing between human beings — three categories — human
beings, or full human beings I think you said, embryos, and fetuses, and
then parts of human beings, such as organs and genes, and so forth.
And I certainly understand the distinction between a human being and a
part of a human being, and I think that is a biological distinction and
can be fully and accurately described as such. It is that intermediate
category that has vexed us in our discussions on other issues as well.
Because it seems to me straightforwardly that the embryonic or fetal —
just at the infant and adolescent stages, are simply stages in the determinant
life of the functioning human organism; that is to say a human being.
So I wonder is the distinction between full human being and embryo and
fetus a biological distinction like the distinction between human being
and part of human being, or is it a value distinction. In other words,
is what is driving that train a value judgement that we can happen to
make, and that at some stages of development human beings lack viability
and what have you, and in stages they have it.
PROF. RAI: Yes, that is a great question, and I totally agree with you
that it is a value judgment.. It is not a value judgment that I am making,
however. It is a value judgment or a constitutional judgment that thus
far the Supreme Court appears to have made, and that is all that I am
The Supreme Court has thus far said or appears to have said, or continued
to endorse the Roe proposition that only post-natal beings are persons
within the meaning of the constitution.
DR. GEORGE: That's what I thought.
PROF. RAI: That is the express language I think in Roe.
DR. GEORGE: Right and I want to get at that, because that is a very
interesting question about the interpretation of Roe.. When Justice Blackmun
discusses the question of whether the unborn human being is a person within
the meaning of the constitution, and concludes that the unborn human being
is not a person for constitutional purposes, you may recall that the argument
has to do with the fact that there aren't, for example, post-natal applications
of constitutional provisions, like the provision that to become President,
a person must be 35 years old, and obviously that can't apply to the pre-natal
And needless to say, Justice Blackmun has come in for tremendous criticism
as to that, and I am interested now in your interpretations of it, because
as I hear what you are saying, and please correct me if I am wrong, you
seem to be suggesting that we could infer from Blackmun and the Court's
conclusion, that the unborn human being is not protected as a person by
the constitution, such that the right of the woman to terminate pregnancy
is protected in the constitution and not contradicted by competing personal
claims of the embryo.
PROF. RAI: Right.
DR. GEORGE: I thought that you were suggesting that leads to the inference
that statutorily Congress, for example, and leaving the patent office
out for a moment, would lack the authority to treat or confer the rights
of the person on whatever now — birth is not in the picture now. So in
other words, the human being at an earlier stage of development would
lack that as a delegated power or what have you.
And would lack it when I think — and I am criticizing what I think you
said, but when I think that would make sense at all, because plainly Roe
is simply in those passages saying that Congress cannot confer rights
or States cannot confer rights on the unborn human being that would conflict
with Constitutionally protected rights.
It would be an entirely different matter the question of whether Congress
can confer personal rights on a dog.
PROF. RAI: Absolutely. I absolutely agree with you. I didn't mean to suggest
that Congress lacked the constitutional power to confer personage on pre-natal
humans. I didn't mean to suggest that, although clearly which power it
would attach to exactly, I had not really thought through which power
it would be.
But I don't mean to suggest without having thought about it, anything
along those lines. You are absolutely right that in the abortion context,
there is a competing constitutional right; whereas, in these cases, there
would not be.
DR. GEORGE: Yes, that's right.
CHAIRMAN KASS: We are already over. First of all, I want to thank the
three panelists for really a very stimulating and very, very helpful presentation.
Steve, if we can get copies of those slides. We have got the transcript,
and its patented, and we will take it out on a license, and the same from
you, Andrew. We would be delighted to have that.
Thanks to the council members, and — please.
PROF. KEVLES: I, too, found the discussion here this morning fascinating.
Will the transcripts be available to everybody?
CHAIRMAN KASS: The transcripts of all of our meetings are now on an expedited
track, and if things go well, they would be on our website maybe as early
as the end of next week. It is www.bioethics.gov. Members of the Council,
thank you very, very much. We will be in touch with you very early in
the week about the next steps. The meeting is adjourned.
(Whereupon, at 12:24 p.m., the meeting was concluded.)