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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.


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?


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.

  - The President's Council on Bioethics -  
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