"This transcript has not been edited or corrected, but rather appears as received from the commercial transcribing service. Accordingly, the President's Council on Bioethics makes no representation as to its accuracy."
FOURTH MEETING
Thursday, June 20, 2002
Session 6: Regulation 4: Patentability of Human Organisms 2: Ethics and Public Policy
Steve Holtzman, Infinity Pharmaceuticals
Andrew Kimbrell, International Center for Technology Assessment
Arti Rai, University of Pennsylvania
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
Advisory Commission.
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
Commission.
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
pinheads.
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
or therapy.
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
businesses.
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
donors.
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
tissues.
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
271G protection.
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
go after?
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
inventions.
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
be practiced.
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
patentability.
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
matter.
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
symptoms.
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
like this.
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
manipulate it.
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
to them.
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
embryos.
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
you.
CHAIRMAN KASS: Thank you very much. The second presentation by Andrew
Kimbrell.
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
thorny issues.
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
children.
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
claims.
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
children.
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
objection.
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
issue.
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
been patented.
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
being.
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
is.
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
forms.
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
up.
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
medicines.
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 personal.
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
directly.
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
judgments.
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
to turn.
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
enterprise.
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
technology directly.
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
or morality."
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
it.
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
the environment.
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
comodification.
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
system.
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
of association.
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
various sorts.
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
action here.
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
employ.
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
human organisms.
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
true through.
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
that correct?
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
being patentable.
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
an exaggeration.
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
Bill.
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
do.
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
us.
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
these comments.
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
place.
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
amoral.
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
issue.
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
is comodification.
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
almost.
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
explicit way.
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
10 years.
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
to --
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
questions.
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
suggesting.
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
state.
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.
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