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Thursday, June 20, 2002

Session 5: Regulation 3:
Patentability of Human Organisms 1: History and Current Law

Daniel J. Kevles, Yale University
Karen Hauda, U.S. Patent and Trademark Office

PROF. KEVLES: Thank you very much, Dr. Kass, and a thank you to the Members of the President's Council for this opportunity to tell you a bit about this issue of patentability. I should say that I first got interested in it in the late 1980s when the patent office announced that you could get a patent on a mouse, an animal, and I just thought that it was intriguing, and I began to wonder how in the world did this come about.

Obviously, there was a lot of controversy that surrounded it and so on, and so I began looking into the issue, and since then have embarked on writing a book about it, but got interrupted with a couple of other books in the interim, and going back to writing a book about it now. So it is particularly timely for me.

Very few people were interested in it in the late 1980s, but as is evidenced by the invitation to me to appear before the President's Council, has become a much more charged and important issue, not only in the United States, but also in Europe.

What I am going to do is provide a summary of highlights of what I know about this issue of this patenting of living organisms from the late 19th century, and then provide some reflections on closing.

I have been asked to speak for about 20 minutes, and so I will arrange my remarks to at least attempt to fall within that purview, and if I am going on too long, Dr. Kass, would you please just give me a high sign and I will finish.

Okay. First, with regard to patentability. The key issues or the key points to make here as to what is patentable historically are that, first — and this phrase was coined by Thomas Jefferson in the patent law of 1793, that it must be, among other things, that the invention can be a new composition of matter.

Second, however, what is relevant to our concern is that in 1889 the Commissioner of Patents ruled that you could not get a patent on a so-called product of nature, something that you found in the fields, for example.

That doctrine had come and since then had played a role in limiting patentability to non-living organisms. However, beginning in the early 20th century after the rediscovery of Mendel's laws of genetics, and plant and animal breeders begin to think that they might be able to acquire some sort of patent protection for the products of their labors.

Their efforts, which produced in 1930 the Plant Patent Act. They argued, that is, the plant breeders, and horticulturists, and so on, that they had a right to be protected in the fruits of their labors just as did physical inventors, like Thomas Edison.

The Congress agreed with them and passed the Plant Patent Act in 1930. However, the coverage, or the scope of what was patentable under the Plant Patent Act was limited for interesting reasons.

It is limited to asexually reproducing plants. For example, plants that you can reproduce by cuttings, or vines, that tend to reproduce themselves asexually. If you walk into your local nursery, for example, you often find roses that say patented with a number.

And that is because a rose as you know can be reproduced by a cutting. The reason for this limitation were that, first, in order to have a patent it was assumed that you have to be able to control the product to produce it identically at will; and secondly, that it must be highly specifiable.

The problem with sexually reproducing plants is that you cannot control, or at least you could not control at that time what the offspring would be like because of the mixing of genes from the two parents, and the changes would arise over various generations.

And, secondly, it was very difficult to specify, partly because you can't control it, but partly because it is a living organism, exactly what the product is.

So on the assumption that no property right is worth anything if you can't enforce it, and you can't enforce it if you can't specify the property, the Congress decided to limit the coverage to asexually reproducing plants.

The next landmark in our story is a ruling by the United States Supreme Court in 1980 in the case of Diamond versus Chakrabarty. Chakrabarty was a biochemist at General Electric, and he devised a bacterium in the early 1970s that was genetically modified so that it would consume oil.

His claim for the patentability of this product rested in part on the fact that the product was highly specific because it was genetically modified, and by that time it was well established that genes are chemicals, and therefore you could specify it as a composition of matter.

And furthermore, it could be controlled because of the constancy of the genetic material. The Patent and Trademark Office, however, objected to and rejected Chakrabarty's claim on the grounds of invoking the product of nature doctrine from 1889, and it was a product of nature, and a living organism, and then rejected it also on the grounds that it was alive.

And it cited the Plant Patent Act, reasoning that when Congress had passed the Plant Patent Act, and it implicitly declared to extend the scope of patentability to anything alive would require an act of Congress, and of course here there had been no act of Congress.

Chakrabarty appealed the rejection, or to say that G.E. did on his behalf through the courts, and hence the case reached the Supreme Court in late 1979, and the ruling came in 1980.

The ruling granted Chakrabarty his patent, but it was only by 5-to-4. The Court said in response to the arguments made by Chakrabarty's lawyers and also a number of friends of the court briefs, that the product, the bacterium in question, was not a product of nature. It was a product of Chakrabarty, and that it was in short man-made.

Furthermore, it was a new composition of matter because it had to do with changing the chemical DNA in the product. And thirdly, and perhaps most important, it ruled that whether an invention is alive or not is irrelevant to its patentability.

The dissenters in the case, the four, held that this really was a charged social issue. It arose at the time of the recombinant DNA wars in the United States, and in Europe, and which opened up the prospect of the engineering of all of life.

And given the charged nature of the case and its implications, the dissenters held that really this should come before the Congress. However, the majority disagreed and went on to rule as I have said.

During the arguments on the case, and as I said, a number of amicus briefs were filed, and among them was one from the People's Business Commission as was then called, which was the non-profit organization headed by Jeremy Rifkin, who had already established himself as a staunch opponent of genetic engineering.

Among the numerous arguments raised in the PBC's brief was that there were profound implications here that if you were to say that an organism is patentable, and its being alive is irrelevant, and that anything that is a new composition of matter could be patented, then that would leave no logical space, or no logical obstacle, to the patenting of higher life forms, including possibly human beings.

Observers in the wake of the court's ruling agreed with this reasoning and warned of that possibility. The court at the time ruled or held in its ruling that whether these implications might or might not be true, but it could only decide the case before it which concerned the bacterium and had been devised by Chakrabarty, and hence the ruling that I have described.

But the implications that were drawn were I think quite substantive and material. As a result, in 1985, the patent office awarded a patent on a plant, which meant that any plant could then be patented so long as it qualified or met the criteria for patentability, including new composition of matter, et cetera.

Then in 1987 the Board of Patent Appeals and Interferences in the Patent Office ruled in a case, Extra Parte Allen, allowing in the case of Ex Parte Allen, allowed the patenting of higher organisms, including animals.

The case involved an oyster that had been chromosomally altered by a laboratory at the University of Washington so that it would be sterile. It is always amusing to me why they wanted to do this, and it turns out that this oyster naturally spends three months of its life each year reproducing, and at that time the flesh of the oyster is much less eatable.

So if you could force the oyster not to reproduce ever, then you could have an increase in the eatability of these oysters by 33 percent over time, and that would be a great boon to the oyster industry in Washington.

Well, the Patent Office, the examiners, initially ruled against the claim on the grounds that the oyster was a product of nature and furthermore that the modification that had been engineered into the oyster was obvious to anyone schooled in the art of oyster breeding, and something that as obvious as by patent practice not testable.

The Board of Patent Appeals and Interferences agreed with the reasoning that it was obvious, but it held that a higher organism could be patented. It cited Diamond v. Chakrabarty, and the doctrine of whether an invention is alive or not is irrelevant and cited the point that new compositions of matter were patentable.

At the same time, the Board revealed its sensitivity to the apprehensions that emerged in the wake of Diamond v. Chakrabarty, namely the apprehensions about the potential patentability of human beings. So it declared that human beings are not patentable by reason of the 13th Amendment to the United States Constitution.

The 13th Amendment, of course, overturned the Dred Scott case, in which the Court in the 1850s did hold that one human being could hold a property right in another. The 13th Amendment basically said by implication that a human being cannot hold a property right in another, and a patent is a form of intellectual property right.

So for one human being to hold an intellectual property right in another human being is a violation of the 13th Amendment to the Constitution. The next landmark and the final one for our purposes here is that in 1988 the court, basing its decision on Ex Parte Allen, or I mean the Patent Office, basing its decision on Ex Parte Allen, issued a patent without any objection whatsoever in the Patent Office, to Harvard University for a mouse that had been genetically engineered in its laboratories, to be supersusceptible to cancer.

Now, the reason that it was a new composition of matter is that it had introduced into it at the stage of being a newly fertilized egg an oncogene, and therefore, the oncogene being DNA, made the mouse a new composition of matter and therefore under these accumulating precedents of Diamond v. Chakrabarty, Hibberd, and Ex Parte Allen, and the mouse was patented.

Now, what I want to conclude with is a set of observations concerning the ethical issues as they arose either implicitly or explicitly in the course of this history.

First, with regard to the patent system and the rights of inventors. One reason for the patent system in the United States and in other countries is of course for the practical purpose, the consequential purpose of encouraging innovation, by securing to inventors the fruits of their labors.

But secondly there is an ethical premise it seems to me in that doctrine, or in that policy, namely that inventors have a moral right to the fruits of their labors. One can see this moral right invoked in the attempts by breeders, for example, starting early in the 20th century to obtain intellectual property protection in the plants that they would devise.

The moral right was expressed in a Congressional hearing in 1906, and it certainly suffused the discussion and debates that preceded the Plant Patent Act in 1930, without intellectual property protection, and without the patent for the fruits of their labors in the case of plants, and it was claimed that in fact that others would just simply steal from inventors, and leave — that is, plant breeders, and leave them no recourse.

Secondly, since Diamond v. Chakrabarty, and the debates starting actually in the '70s when the case was beginning to work its way through the courts, but certainly since Diamond v. Chakrabarty in 1980, and especially since the award of the patent to the Harvard mouse, opening the door to animal patents, the ethical objections to patents have arisen.

The one class of these objections is to the patenting of life per se as such, without regard to whether it is a plant, an animal, a human being, or whatever.

This objection is to be found vigorously advocated in the brief of the People's Business Commission, and before the Court in Diamond v. Chakrabarty, but it has also found expression since then from clerics, from animal rights activists, once Ex Parte Allen allowed the patentability of animals, and so on, and also from certain groups of environmentalists.

The basic argument advanced in this ethical regard is that to patent life is to hold that it has no vital or sacred character. That it is commidifiable in ways that are no different from, say, tennis balls.

A second particular ethical objection, which is sort of a subset, but important for our purposes, is that to allow the patenting of life, especially animals, implies the potential patenting of human beings.

This possibility was disparaged in the amicus briefs on behalf of the biotech industry, the American Pharmaceutical Manufacturers, and so on, and Genentech, then a new company, in the debates over Diamond v. Chakrabarty before the court.

And saying that this is just carrying the doctrine of patentability of living forms beyond reason. And that potential of patenting human beings would seem to have been blocked entirely by Ex Parte Allen, which says explicitly that you cannot get such a patent.

However, in the wake of the ruling of Ex Parte Allen allowing animal patents, and then Harvard's mouse patent, there was sufficient controversy that arose to prompt Congressman Robert Kastenmeier, who was then head of the appropriate subcommittee of the House Judiciary Committee, to hold hearings on the patenting of animals.

The ethical objections were raised but there were also other objections raised to the patenting of animals, especially by farm groups, agricultural groups, on the grounds that this was going to be disruptive to the agricultural economy and work adversely against the interests of small farmers.

In a sense, it would be another case of how the advent of technology, which may involve higher capital costs, tends to work or to favor better capitalized or agricultural groups, and to disfavor those that are less capitalized.

So there was a melange in the hearings of these ethical objections, plus consequentialist objections, and one of the major conseqentialist objections for everybody in the agricultural community, agri-business and small farmers, was who owns the progeny in impacted animals.

This was an issue that had never arisen before in the system because no invention had ever been capable of reproducing itself. But now with living organisms, you did have such capability.

In the end, Kastenmeier and his subcommittee concluded that the ethical objections had no place in the considerations of American patent law; that U.S. patent law is literally amoral. All it does is to grant an exclusive right to make, use, or sell an invention, or to exclude others from making, using, or selling it.

But with regard to the ethical objections that the subcommittee held, that Kasternmeier did, were excluded from American patent law, but did have a place in public policy because even though a patent really grants the exclusive right, it does not give you the right actually to make, use, or sell an invention.

For example, just to take an extreme example, if you were to invent a new nuclear weapon in your basement, you could get a patent on it. But that wouldn't give you the right actually to make the weapon, or to sell it, et cetera, et cetera.

That would obviously come under rules of national security, public health and safety, and so on. And so Kastenmeier held, as did his subcommittee, that the literal amoral nature of American patent law relegated to all the regulatory safety agencies of the government, and to Congressional action, the implicit ethical issues concerning these matters.

However, Congressman Kasternmeier did attempt, and did think it important to deal with the consequentialist issues arising from the patentability of animals, namely as they might affect farmers. And he constructed a bill that in part held that the patent holders would not have rights in the progeny of patented animals, simplifying the system, et cetera, and assuming that therefore the price, the lack of property control over progeny would be reflected in the initial price.

Secondly, however, he also included in his bill a provision by statute that would prohibit the patenting of human beings. He was not satisfied with the reliability of Ex Parte Allen, and so he incorporated that provision into the bill.

This bill passed the House of Representatives in 1989, but it died in the Senate, and since then there has been no action in the Congress. Then finally what is the current state of affairs with regard to human beings.

Well, Ex Parte Allen still prevails, but it is still possibly — I am not enough of a lawyer or patent policy expert to say, but possibly it is vulnerable. It seems to me though to have a pretty solid foundation, because it is not just a casual regulation. It is a legal ruling by the Patent Office itself.

But even if Ex Parte Allen should remain a solid fixture of American patent law, it omits consideration of what constitutes a human being. Is it a human being in its totality only, or does it also its parts — the organs of the human being, the liver, kidney, or whatever.

We do know that with regard to the patentability of those things that there is precedent in the patentability of human genes. Human genes have been patentable without objection initially since Genentec I think took out the first human gene patents in the late 1970s.

The ethical objections have been raised to the patentability of human genes, per se, but it seems to me that we have at least equal concerns, or we should have equal concerns of a consequentialist nature.

Gene patents are treated as absolute property rights, and we can see already that the way that private companies are dealing with their property rights in human genes is creating problems for medical research, and already even in the diagnostic area.

The medical research is problematic, and problems are arising in medical research arise from the fact that expensive licensing fees are being charged by some companies for people just to do research on these genes.

And it seems sort of paradoxical and bizarre to a number of observers that if you wanted to take a gene from your own body and do research on it that you can't do it without paying a license fee possibly to whoever owns the patent.

Secondly, these genes are important, and a growing number of them are in medical diagnostics because they can tell you, for example, which oncogene has gone wrong in your body, et cetera, and give a much more specific diagnosis of, say, cancer, and then you multiply those examples over a number of diseases.

It seems to me that quite possibly the notion of gene patents at least in human beings, and possibly other forms of possible patents in human beings, ought to be explored as whether this should be an absolute property right.

My own view personally is that it ought not to be. One can make analogies because it is a very limited resource. I mean, we have lots of genes, but we only have a finite number of them, some thousands, 30 to 40,000 at current estimates, and obviously they are all very important to us, especially with regard to biomedical research.

And one can analogize this limited resource to, for example, by riparian rights, and there are other analogies that you could make in the history of property law in the United States, possibly the electromagnetic spectrum.

But in the case of riparian rights, for example, we do not allow I think in most States people through whose property water rivers run to treat their property in an absolute way, because it is a public resource.

Downstream has interests in what is upstream, et cetera, and so all of us have interests in what happens to human genes, and how they can be used in biomedical research, and in diagnostics.

The bottom line for all of this in sort of summary it seems to me is that there has been no adequate, despite the valiant efforts of Congressman Kastenmeier, no adequate effort on the part of the Congress to explore in a thoughtful way the — and in a sufficiently serious way, the sense of being high enough on the public agenda to do something, adequate consideration of the myriad issues arising from the patentability of living organisms, but particularly in the human area.

I think that Ex Parte Allen is okay, and I don't think that anybody would object to disallowing patents on human beings as a statutory matter. But we have these other sort of infrastructural issues in human beings, which are now increasingly on the front stage center of intellectual property, biotechnology, biomedicine, and so on.

And it seems to me that there is more than a compelling reason for the Congress, and possibly prompted by the deliberations of this council, to examine in an serious way what these intellectual property rights might be, and what their scope might be, and what their limitations might be.

CHAIRMAN KASS: Thank you very much. I think in the interest of making sure that we have got full time for discussion that we should have the second presentation, and then discuss the two together if that is all right with everybody, unless there is something burning that anyone wants to ask Mr. Kevles. Please, Ms. Hauda. Thank you.

MS. HAUDA: Good morning. I would like to thank Dr. Leon Kass, Chairman of the President's Council on Bioethics, for inviting me here today on behalf of the United States Patent and Trademark Office. I will refer to this as the USPTO.

In my testimony, I will briefly outline the present state of the law and current policy of the USPTO regarding the patenting of life forms. I then will discuss recent technological developments that have raised new questions concerning patent eligible subject matter.

We welcome the advice and guidance of the President's Council on Bioethics as we consider these important issues. The President's Council on Bioethics may also want to consider recommending that Congress clarify its intent regarding patent-eligible subject matter.

The basis for the U.S. patent system is found in Article I, Section 8, of the Constitution, which provides that Congress should have the power to promote the progress of science and useful arts by securing for limited times to inventors the exclusive right to their discoveries.

In response to this Constitutional authorization our founding fathers designed an extremely flexible patent system based on principles that have proven remarkably suitable to 210 years of unceasing technological advancement.

Basically, in exchange for the full disclosure of an invention meeting the criteria of the patent law, the government grants the inventor of a patent, that is, the right to exclude others from practicing the invention for a limited time, now 20 years, from the filing date of the application.

Indeed, one of the key tenants of our patent system is that it is technologically neutral. For example, from gear shifts to genomics, it applies the same standards to all inventions in all technologies.

While some are critical of this aspect of the patent system, the uniformity and applicability of the patenting standards of novelty, of obviousness and utility, coupled with the incentives patents provide to invent, invest in, and disclose new technology, have allowed millions of new inventions to be developed and commercialized.

This has enhanced the quality of life for all Americans and helped fuel our country's transformation from a small struggling nation to the most powerful nation in the world.

In administering the patent system, USPTO takes its direction on what subject matter is patentable from Congress and our review in Courts. The current Act details the standards of patentability, and the Patent Act of 1952 specifies four basic statutory requirements that must be met to obtain a patent.

First, the claimed invention must be eligible subject matter and have utility. Second, it must be novel. Third, it must not have been obvious to a person having ordinary skill in the art at the time that the invention was made; and, fourth, it must be fully disclosed in the text of the patent application and enable a skilled practitioner to practice the invention without undue experimentation.

Prior to granting a patent, the USPTO examines each patent application to determine whether it meets these four criteria as set out in Title 35 of the United States Code. The pertinent statutory provisions defining the subject matter that is eligible for patenting is 35 U.S.C. Section 101, titled, "Inventions Patentable."

This section reads whoever invents or discovers any new and useful process, machine, manufacturer, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore subject to the conditions and requirements of this title.

Congress deliberately used expansive terms in describing in describing the categories of inventions so that unforeseen technologies wouldn't be included without the need for constantly updating the patent law.

The scope of patent eligible subject matter, however, is limited in part by the product of nature judicial doctrine, which provides that naturally occurring products are not patentable.

Under this doctrine, the mere discovery of a previously unknown naturally occurring product is not patentable. The courts, however, have long held that a purified composition of matter, such as a chemical compound isolated from nature, is a human made invention eligible for patenting, rather than an ineligible product of nature.

For example, purified prostaglandins isolated from human prostate glands are not naturally occurring and are therefore patent eligible subject matter because the pure form does not exist in nature.

Nevertheless, for many years the USPTO used the products of nature doctrine as a bar to patent living subject matter. In 1980, the Supreme Court decided the landmark case of Diamond v. Chakrabarty, addressing the patentability of living subject matter, and specifically of genetically altered bacterium capable of breaking down crude oil.

After a careful consideration of the history of Section 101, the Supreme Court reversed the USPTO's position that microorganisms, even genetically altered ones, were products of nature as living things, and were per se, non-patentable.

The Supreme Court held that the statutory language of Section 101 was intended by Congress to be broad enough to include anything under the sun that is made by man.

Under this analysis the Supreme Court held that a living man-made microorganism qualifies as a manufacture or a composition of matter under the statute. The court explained that the relevant distinction for the purposes of patent eligibility was not between living and inanimate things, but between products of nature, whether living or not, and human made inventions.

Consistent with the Chakrabarty decision, Federal Courts have routinely upheld the patentability of products that have been modified or purified from nature. In the wake of the Chakrabarty decision, the USPTO has issued thousands of patents to living material, where the products are the result of human intervention and do not exist naturally in that form, provided that all other criteria of patentability are satisfied.

The USPTO issued the world's first transgenic animal patent in 1988 to the now famous Harvard Onco-mouse, a mouse genetically engineered to be more susceptible to tumor growth. Patents have since issued on numerous other genetically altered plants and animals.

It should be noted, however, that in holding the microorganisms for patent eligible subject matter, the Supreme Court was aware of the lower court's view that we are not dealing with patent eligibility of all living things, including man.

The USPTO concluded that inventions covering human beings are not within the scope of Section 101, and in 1987, published a notice in the USPTO's official gazette advising the public of its conclusions.

The USPTO concluded that Congress never intended for a human being to be considered a manufacturer or a composition of matter under the patent law.

More recently, an immediate advisory issued in 1998, the USPTO reiterated its policy that an invention, including within its scope a human being, could not be considered to be patentable subject matter under 35 U.S.C. Section 101 because it would be against public policy to do so.

Shortly after the USPTO published its notice of intent not to patent human beings, it informed Congress of the decision by direct testimony in a 1987 hearing before a subcommittee of the Committee on Judiciary, House of Representatives, on the patents on the Constitution of Transgenic Animals.

On June 11th, 1987 the USPTO's Assistant Commissioner testified that a claim, including a human being within its scope, will not be considered to be patentable subject matter.

In the 15 years since it was notified of the USPTO's interpretations, Congress has apparently acquiesced to the USPTO interpretation. Further, the Federal Circuit held in 1991 that the USPTO has the authority to establish its policy through interpretative authority.

Guidance on the topic of patentability of living subject matter is provided to the USPTO patent examiners and to the public in Section 2105 of the USPTO Manual of Patenting Examining Procedure, otherwise known as the MPEP.

Generally speaking, living things are patent eligible. Let me briefly outline per USPTO policy regarding the patent eligibility of various forms of living subject matter.

First, animal or plant cells, or human stem cells. In view of Chakrabarty, the USPTO has applied the same reasoning applied to purified and/or isolated products of nature to animal and plant cells, including human stem cells.

A naturally occurring animal or plant cell is a composition of matter and may be eligible for patenting when the inventor describes and claims it in a purified form. For example, in the form of a cell line or a cell culture.

The purification process is human intervention in nature, and maintaining the cells in a non-naturally occurring state if a cell culture distinguishes the cells from the mere product of nature.

Of course, any such claim is subject to other requirements of Title 35, such as novelty, non-obviousness, and adequate disclosure. For example, a cell culture of human skin cells said to be useful for skin grafting may be a manufacturer or a composition of matter eligible for patenting.

However, such an invention must also past the test for novelty, non-obviousness, and adequate disclosure. Additionally, if human cells are maintained in cultured, non-natural state, the cultured cell line would be eligible for patenting.

Genetically engineered animal and plant cells are made by human intervention, as was Chakrabarty's bacterium. While these kinds of inventions might be expected to routinely pass the non-naturally occurring test, there must be evidence that the invented cell is different from nature's handiwork in some measurable and useful way.

If not the claim is usually rejected and directed to non-statutory subject matter, as well as for lack of novelty. With respect to animals, plants, and non-human embryos, for the reasons discussed above, the USPTO issues patents on non-human animals and plants.

When the invention is the result of human intervention and nature, and the conditions of Title 35 are met, non-human, animal, and plant embryos — and for plants an embryo is typically a seed — are eligible for patenting when the embryo is different from the nature's embryos.

The invented, non-human animal, plant, or embryo, must be distinguishable from its naturally occurring counterpart.

Human beings and human embryos. MPEP, Section 2105, concludes with this instruction. If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human being, then a rejection under 35 U.S.C. 101 must be made indicating that the claimed invention is directed to non-statutory subject matter.

When a patent claim includes or covers a human being, the USPTO rejects the claim on the grounds that it is directed to non-statutory subject matter. When examining a patent application, a patent examiner must construe the claim presented as broadly as is reasonable in light of the application's specification.

If the examiner determines that a claim is directed to a human being at any stage of development as a product, the examiner rejects the claims on the grounds that it includes non-statutory subject matter and provides the applicant with an explanation.

The examiner will typically advise the applicant that a claim amendment adding the qualifier, non-human, is needed, pursuant to the instructions of MPEP 2105.

The MPEP does not expressly address claims directed to a human embryo. In practice, examiners treat such claims as directed to a human being and reject the claims as directed to non-statutory subject matter.

The rejection is withdrawn if the inventor amends the claim with the term non-human to exclude human being. Processes of preparing cell lines and methods of culturing cells are eligible for patenting because laboratory processes are not natural phenomena, and involve human intervention in nature.

This also means that laboratory processes or methods for making human cells and culturing human cells are eligible for patenting. Similarly, methods of manipulating non-human animal or plant cells to form embryos are patent eligible.

Cell cultures are used in a variety of ways, including immediately practical procedures such as surgical intervention. For example, using cultured cells to treat bur victims.

Methods of using the cells are also eligible for patenting as process interventions when they provide any practical utility. Thus, cloning procedures fit in the process invention category, and cloning is eligible for patenting subject to the conditions of Title 35.

Surgical procedures on human patients are eligible for patenting and can be directed towards techniques or use of materials such as implants. As applied to whole animals, the term cloning has several different meanings.

Cloning can occur naturally, such as in identical twins or triplets. Additionally, there are two quite different artificial laboratory procedures aimed at duplicating embryos that have been termed cloning.

Blastomere separation and nuclear transplantation. Also known as embryo splitting, blastomere separation is an artificial cloning procedure that involves isolating individual cells of very early embryos, and growing them into separate embryos.

Blastomere separation has been used successfully to increase the pregnancy rate in cattle. Nuclear transplantation is an artificial cloning technique that involves removing the nucleus from a cell and inserting the nucleus into an unfertilized egg from which the nucleus has been removed, an enucleated cell.

The clone cell is then implanted into a surrogate mother and allowed to grow to term. Somatic nuclear transplantation involves moving the nucleus from a somatic or adult cell into an unfertilized egg, as opposed to embryonic cell nuclear transplantation, in which the nucleus is transferred from an embryonic cell.

Somatic cell cloning is the process that lay persons typically refer to as cloning, in which an existing animal, adult animal, is cloned. Scientists in the Unite Kingdom were the first to report a cloned animal by somatic cell nuclear transportation.

The resulting lamb, named Dolly, is genetically identical to the sheep from whose cells the donor nucleus was taken. Following the successful cloning of Dolly the Sheep, many other animal species have been cloned using nuclear transfer techniques.

These include mice, pigs, cows, monkeys, cats and rabbits. There have been press reports that some researchers are pursuing human cloning using similar techniques.

Before closing, let me address the possible need for legislation. The current policy of the USPTO is to consider any claim encompassing a human being at any stage of development, and not to be patent eligible subject matter under 35 U.S.C. 101.

Several legal arguments may be used to exclude the patentability of claims directed to human beings. To date, the court's have not addressed this question. Legislation may be necessary to ensure that this subject matter is excluded from patentability.

As was noted earlier, Section 101 of the patent law contains the requirements that a patentable invention be new and useful, and fall within one of the statutory categories of process, machine, manufacture, or composition of matter.

Canons of statutory construction favor the ordinary meaning of the terms, and the ordinary meaning for the terms manufacture and composition of matter does not include a human being. Conferring exclusive rights over a human being would also raise constitutional questions, and canons of statutory construction counsel the interpretation that avoids constitutional issues.

In addition, the courts have interpreted the utility requirement to exclude inventions deemed to be injurious to the well-being, good public policy, or good morals of society.

In light of the above statutory and judicial constraints, the USPTO has for 15 years taken the position that it will not issue a claim directed to a human being or a claim that could be interpreted as being directed to a human being.

Any actions taken by the USPTO must have legal basis under Title 35 of the United States Code, as interpreted by the Federal Courts of the United States. The USPTO also lacks substantive rule making authority.

Legal challenges will therefore likely be raised to the USPTO's interpretation of statutory subject matter under Section 101. A challenge to the non-patentability of human beings would be a case of first impression to the court.

The resulting outcome, especially on public policy grounds, is uncertain. In the Juicy Whip case, the Federal Circuit questioned the continued viability of the principle that inventions are invalid if they are principally designed to serve immoral or illegal purposes, noting that this reasoning has not been applied broadly in recent years.

In addition to the role of the USPTO as a gatekeeper for the public, it is recognized that strong patent protection has been vital to the development and commercialization of innovations in biotechnology.

The U.S. biotechnology industry has more than doubled in size since 1993, with revenues increasing from $8 billion in 1993, to $22.3 billion in 2000. Experience in the biotechnology industry has been that patents in this area are widely licensed, and are considered to be some of the most profitable patents.

The profitability is largely due to their widespread use and advancement of biological research. These advances would not have been possible without broad patent eligibility and the balanced patent system strikes between generating intellectual property and distributing those ideas.

Despite the benefits afforded by the technological advancements, however, some technologies are raising profound legal and ethical issues. Until recently, scientific research had not reached a level that would require the USPTO to confront claims directed to a human being or methods of making a human being.

As I discussed that has now changed. Given the uncertain outcome of legal challenges to the exclusion of humans from patent-eligible subject matter, legislation may be required to ensure their exclusion.

However, any restrictions that would limit the patent eligibility of biotechnology inventions must be carefully crafted to avoid unintended consequences, such as general negative effect on the investment in the biotechnology sector.

Too much restriction could result in the loss of highly respected and prominent researchers from the U.S. to countries that may provide greater protection or stronger research advantages.

The USPTO therefore welcomes the guidance and analysis of the President's Council on bioethics as we attempt to address these issues. I would be happy to answer any questions that you may have, and would like to assist the council in answering these questions.

My testimony today has been approved through all appropriate channels. Please understand, however, that my answers to questions are my own, and do not necessarily reflect the views of the USPTO or the Administration. Thank you.

CHAIRMAN KASS: Thank you. Thank you both for very lucid and helpful presentations. Before I throw the floor open, I would like just to clarify for myself that I have understood certain matters.

From Professor Kevles, I take it that you would agree that in terms of the gradual expansion of the terms of patent statutes to allow increasingly for the patent of living things that as you read the development, you don't at the moment see any obvious obstacle to the further expansion of these things to include human materials, even though that has not yet been granted..

And particularly that there is a kind of ambiguity about what you mean by human things.

PROF. KEVLES: That's right. First, it seems to me that the ruling in Ex Parte Allen still holds, and by the argument of Karen Hauda here, it has been tacitly accepted by the Congress, because the Congress has not done anything to contravene it.

Secondly, that applies, and which I think is the understanding, to whole human beings like us sitting around the table.

Secondly though, it leaves open the question of what is a human being, and does a human being extend to its parts. We do know, however, that human genes are patentable, and we have many patents on human genes.

And so it is not the case that all parts of human beings are automatically excluded, and that is just a fact. It does raise the question therefore with all due respect as to what the courts might do, no matter what the patent office policy is, with regard to applications on other parts of human beings.

And we do have historical precedent to strongly indicating that the policy of the patent office has not always prevailed in the patentability of living subject matter.

The patent office as I have said adamantly resisted the claims of Chakrabarty. It resisted the claims of Standish Allen, the claims of Hibberd and so on, and those claims were overturned in the first instance by the Supreme Court of the United States, and in further instances by the Patent Office's own legal appeals board.

So how this will all work out is not altogether a matter of statutory — has not been altogether a matter of statutory law, and what is non-statutory has changed over time. So that is why I conclude that some, I think, clear clarification of this comparable to the overall of U.S. patent law in 1952 might be in order given the increasing possibilities of engineering different things that you might call human, or at least parts of human.

CHAIRMAN KASS: Thank you. And for Ms. Hauda, you say that at least the official policy of the patent office having to do with human things is answered in terms of the language that this is not statutory subject matter.

The patent office doesn't speak about the 13th Amendment, and that is not part of the official language. It is the 13th Amendment, for example, that is the grounds of your restriction.

I mean, the patent claim comes in — the official answer is as you indicated this is the patent office's interpretation of the statute, and the patent office has the authority to interpret the statute, and therefore — am I understanding that correctly?

MS. HAUDA: Yes. Our policy is that we will not issue a claim that includes within its scope, or is directed to a human being in any stage of development.

That policy is based on statutory interpretation of the Constitution have been interpreted by the Federal Circuit Courts and the Supreme Court of the United States.

So in interpreting those, there are for bases for which the USPTO relies on with respect to that. And why human beings are not patentable, and that would include the patenting of a human being does raise Constitutional questions.

It also includes that the terms or the composition of matter and manufacturer do not in their ordinary meaning and parlance include a human being, and that the utility requirement of Section 101 does raise public policy issue, and that it cannot be injurious to the well-being and good public policy of the statute.

And fourthly that for 15 years we have been telling Congress that we will not patent human beings, and Congress appears to acquiesce to that also. So we interpret that as part of their interpretation of the statute.

CHAIRMAN KASS: Thank you. The floor is open for general discussion. Rebecca Dresser.

PROF. DRESSER: Thank you very much for your testimony. It seems to me that there is a contradiction. I mean, this general view that the Patent Office decisions are amoral is contradicted by at least the partial invocation of the 13th Amendment as the basis for not granting a patent on a human being.

So certainly in interpreting what constitutes a human being, and not just whether a part constitutes a human being, but what is a genetic human being. So when is a transgenic creature a hybrid, and how many genes does it have to have to be a human.

And to me that really requires ethical analysis, and policy analysis, and sort of substantive analysis, that at least the general view is that the patent office should not engage in.

On the other hand, I am not that thrilled about having — and I don't mean any disrespect, but technicians at the patent office making these kinds of moral decisions. So I guess I don't have a particular view.

But it does seem to me that in this area that there are ethical judgments being made. So it is touch to square with this amoral label on patent law.

MS. HAUDA: When an examiner interprets a claim, what they do is the examiners are instructed to consider what is encompassed within the claimed invention as broadly as is reasonable in light of what is disclosed in the application.

So when a claim comes in, when read in light of the application disclosure could read on a human being at any stage of development, the examiner will make a prima facie case of non-statutory subject matter.

And that is a rebuttable presumption. The applicant can then come in and argue that its not, and based on the prosecution and the disclosure, and what the evidence the applicant can provide, is how that examiner makes that decision.

So the analysis that the examiner undergoes is very technical based on what is disclosed in the application and what the scope of the claims as interpreted under the statute reads on, and it creates a prosecution history within that case as to what the final interpretation of the claims are.

And anything the applicant admits to on the record becomes prosecution estoppel when a court is interpreting the scope of the claims at a future time.

CHAIRMAN KASS: Professor Kevles.

PROF. KEVLES: First, it was Congressman Kastenmeier who basically argued that the patent law is amoral and may be implicit in what the patent office does. But it is my terminology, and so I wouldn't blame it on that.

Secondly though, the phrase, non-statutory subject matter, I think is problematic. That is exactly how the patent office responded to Chakrabarty's claim, and we know what happened with that.

Ms. Hauda will correct me if I am mistaken, but I know of no statute ever passed by the Congress of the United States which says that human beings are not patentable subject matter or their parts. That's why Congressman Kastenmeier thought it necessary to enact such a statute in 1989, even though he failed.

So I think that the foundation here, while it is substantial in terms of precedent probably, is not statutory in any explicit way. Am I mistaken about that?

MS. HAUDA: No, I agree with your statement that there is no statute that says human beings are not patentable. However, the USPTO bases its interpretation of the statute on the case law and the history of what the courts have said.

And the fact that we were overturned in Chakrabarty indicates that living matter is patent eligible, but it is our interpretation of the statute, and based on the 15 years of acquiescence by Congress, and our direct testimony to Congress, that Congress did not intend the terms of the statute, manufacture and composition of matter, to include a human being.

PROF. KEVLES: But it is inferential?

MS. HAUDA: It is interpretative.

CHAIRMAN KASS: Frank Fukuyama and then Mike Gazzaniga.

PROF. FUKUYAMA: Yes. I have a question about Professor Kevles assertion about the amorality of the statute, because my understanding was that there actually was language in the statute which I believe Ms. Hauda quoted that said that the patent office can exclude inventions that are injurious to the morals of society.

But that as a matter of practice, since the 19th century had actually not ever tried to exclude anything on that basis. But there is actually statutory language that would permit that to happen if someone in the patent office decided to go down that path. That is the first question.

The second question is what would happen

— what would be the U.S. policy if, let's say, a human embryo or some complete human being, something that is currently not permitted in U.S. practice was patented in a foreign country, and then that foreign country, through WIPO or TRIPS, would then try to get that property right recognized by the United States.

What would be the U.S. policy in a case like that?

PROF. KEVLES: I may be mistaken about that point that Ms. Hauda just testified to, as to the excludability of patents on inventions that may be injurious to society is new to me. It is certainly — I was basing my view on the considerable body of testimony that came out in the Kastenmeier hearings, and the fact that Congressman Kastenmeier never alluded to this.

I don't know when that phrasing came into the U.S. patent code, and I am eager to see or to find out more about that. Now, I also recall that when Jeremy Rifkin, a scientist, proposed to patent a human animal hybrid, then Commissioner Lehman said that this might be unpatentable on moral grounds, and then he was widely attacked from the entire patent law community, saying that there is no statutory grounding for this view.

So I would say that the issue is at the least ambiguous certainly if you want to pay attention to precedent and the understanding of the larger body of, or larger community of patent lawyers.

With regard to the — and I am sure that Ms. Hauda will have more to say about this than I do, but I would just like to observe that the European patent convention does explicitly include an Article 53A which says that you cannot get a patent on anything contrary to public or morality, it has historically not been invoked until recent years, first with the Harvard mouse.

And there Harvard University had to jump through a number of hoops to demonstrate that this Onco-mouse was not contrary to public order or morality. I would say that the expectation in Europe is that the ethical requirements of patent law might be imposed through WIPO or TRIPS, rather than our imposing amorality on the Europeans.

But it is a very interesting issue it seems to me given of course the globalization of high technology.

CHAIRMAN KASS: Ms. Hauda, did you want to comment in response?

MS. HAUDA: Sure. With respect to your first question, I will just quickly go through some o the cases that have supported a public policy interpretation of the statute.

The United States Supreme Court in Morton Salt Company versus G.S. Suppiger Company, which is 314 U.S. 488, a 1942 case, stated that the grant to the inventor of a special privilege of a patent monopoly carries out a public policy adoption by the Constitution and laws of the United States to promote the progress of science and useful arts by securing for limited times for inventors the exclusive right to their new and useful inventions.

Furthermore, Tol-O-Matic, Inc., v. Proma Product Marketing Gesellschaft, I think you say, 945 F. 2d 1546, quoted from Lowell v. Lewis, which is an 1817 case written by Justice Story, stating that the term useful in Section 101, as used in the patent context, has been construed to include the connotation that an asserted invention should not be injurious to the well-being, good policy, or good morals of society.

Public policy takes into account the common sense of the community and issues that are controversial by nature, and issues that tend to be injurious to the public or contrary to the public good, and this is the general definition of public policy from Black's Law Dictionary.

The resulting outcome of the interpretation of the statute under a public policy reason is indeed uncertain. The Juicy Whip case, Juicy Whip v. Orange Bang Company, which is 185 F. 3d 1364, indicated that inventions are — that questions of viability of whether inventions are invalid if they are principally designed to serve amoral or illegal purposes.

And noted in this holding that has not been applied broadly in recent years, and that was a 1999 case. So we do agree that the outcome in the courts is uncertain, but we also believe that there is a public policy ground that is supported in the case law under the 101 statute.

With respect to your second question on a patent and trying to use TRIPS or WIPO to move patent rights into the United States, patent rights are territorial. They give the right to exclude use, import, sale, and manufacturing of the claim in the patent that was granted.

But they are territorial in right, and so any rights that are granted in another country can't be imported into the United States and vice-versa. A U.S. patent that issues, that right doesn't give any rights overseas.

It only gives the right to exclude for use in import and sale, and manufacturing within the United States.

CHAIRMAN KASS: Thank you. Mike Gazzaniga and Michael Sandel.

DR. GAZZANIGA: Are you aware of the history of why the bill failed in the Senate in '89, and what the reasonings were or the politics, or whatever it was?

PROF. KEVLES: I think it was — the bill passed the house — I am a little fuzzy on the chronology, but if I remember correctly, the bill had passed the house late in 1989. I'm sorry. Yes, I think late in 1989, and then there was a lot of — it didn't get anywhere in the Senate, and it was more or less bottled up.

And then there were the elections in 1990, and Congressman Kastenmeier lost I think in the primary, and was no longer in the Congress to push it, the new Congress to push it in 1991.

I should add though that the burden of my remarks about the history of patentability seeks implicitly at least to locate the development of patent policy and patent law in a larger social economic context.

I don't think you can — this is quite clear in the history of the Diamond v.Chakrabarty case, and in which it is clear that a subtext of everything that was going on was first the charge controversy arising from the advent of recombinant DNA in the mid-1970s, and second the emergence of the biotechnology industry from recombinant DNA, starting with Genentech and so on at the end of the 1970s.

And we are familiar with the boom in biotechnology in the '80s and since. At the time, in the late 1980s, with the end of the Cold War, there was as you will all remember, considerable attention being given to the competitive economic position of the United States in the world.

And a major feature of that discussion was the role of high technology in maintaining and indeed enlarging our country's competitive position in the world. And this discussion had started in the 1970s, and it involved computers, and microelectronics, jet aircraft, and now biotechnology.

And if you look at the world trade balance figures, you can see starting way back that in conventional manufacturers our balance of trade was negative and decreasing. Whereas, in high technology at the time, it was positive and increasing.

And so those considerations figured I'm sure in the attitude of the Members of the Congress and other policy makers, and sort of people in our country who pay attention to those things.

So there was a strong inclination at the time not to do anything that would damage the development of this nascent industry, and indeed to do everything possible to encourage it. You can see strong expressions of that attitude in the debates going on right there at the end of the '80s in parallel on the then new human genome project.

And where biotechnology was understood as a product, and would be an important product of the genome project, and not just information about human genes, but also the technology that would permit you to sequence them rapidly and so on.

And this was going to be very important in arming the United States economically against the Japanese, who were touted at the time to be highly competitive, and they were about to reduce the cost of every base — sequencing every base pair to 17 cents when it was a dollar or more, et cetera.

And so the climate at the time was simply adverse to paying serious policy attention, I think, to these sorts of issues that occupy us today, and I think that is the larger contextual reason that it just died in the Senate.

CHAIRMAN KASS: Michael Sandel.

PROF. SANDEL: Professor Kevles, in your paper you refer to the debate about patenting human genes, and the controversy over the claims filed on breast cancer genes as one example. Have the Europeans under their heading about moral questions, have they rejected or accepted patents on genes?

PROF. KEVLES: Yes, they have.

PROF. SANDEL: Which? Have they accepted them?

PROF. KEVLES: They have accepted them, but I should say that in 1988, and again, at the pending end of the Cold War, the emergence of hi-tech international economic competitiveness and so on, the Europeans, following on the exponential growth of the biotech industry in the United States during the '80s and based in part on Diamond v. Chakrabarty, decided that they had better do something about — in the community, about their biotechnology.

And so they sought to issue a European Commission, which is the executive arm of the community, sought to issue a biotechnology directive. There was a rule in the community that said that you could not get a patent on things that were the result of the natural biological process, and I forget all the language right now.

And so what they wanted to do was to lay a solid foundation and intellectual property rights for biotechnology. It is a measure of the charged nature of this issue, especially in the European community, that it took 10 years for them to get this directive issued.

And a number of the objections raised to it that held it up were those of the type that I have reviewed in my brief remarks, and that I have reviewed more extensively in the written version that the council has in its possession.

In the end the — and then gene patenting because or grew into an issue during this 10 years. In the end the directive was issued in 1998, and it says that you can't get a patent on anything that impairs or is contrary to human dignity, including I think human organs.

But I don't want to be held to that. I didn't review that for this purpose today. But it does say that you can get patents on genes that are of demonstrated utility.

And this is a response to the attempts by Craig Venter, I think, when he was at NIH, and then later with Celera, or TIGR and Celera, to patent human genes wholesale on the basis of knowing their expressed sequence tags, which is just a small fraction of the gene itself.

And without really knowing for sure what the genes do. So it says that you can get — the European Director says you can get patents on genes. It does not constrain what the property right is, but it does make more explicit than might otherwise be the case what you have to know about the gene in order to get a patent.

PROF. SANDEL: But the patented gene means that you have exclusive property rights to any use that might be derived from that gene? What does it mean to patent a gene?

PROF. KEVLES: Well, it means — and Ms. Hauda can expand on that, but my understanding is that it has a — it means that you have the right to exclude others from making, using, selling, importing, whatever.

PROF. SANDEL: For any use of that gene?

PROF. KEVLES: For any use, that's correct, including research in the laboratory. Now, you can forego that, of course, and you can give royalty free licenses and so on, and say only that you can — that you have to pay royalties to us or whatever, to company X, if you develop a commercial product out of this research.

But that is not the way that it has been working in a lot of cases.

CHAIRMAN KASS: Ms. Kass, did you want to comment just on that?

MS. HAUDA: Yes, two things. With respect to the patenting of genes in the United States, the U.S. patent law also has a utility requirement, and the mere isolation of a gene won't result in the patenting of the gene.

The use has to have a specific substantial and credible use. And so there has to be — and so specific means that they need a specific use for it, and not just a use for further research to study the gene.

A substantial use of the gene means that it has to be a real world use. It can't just be a fluff type use, and it must be a credible use. So the utility requirement requires that applicants demonstrate some good use for their gene before it becomes patentable.

With respect to your second question on the patent rights given in a patent, the patent is — the exclusive right that is granted in a patent provides the owner of the patent, or an assignee of the patent, with the right to exclude others from making, using, offering for sale, selling, or importing into the United States the patented invention without the authorization of the right holder.

So with authorization, somebody else could use it. Ownership of the patent does not provide the owner with the right to make, use, offer for sale, or sell, or import the claimed invention, because there may be other legal considerations precluding this.

For example, the existence of another owner with a dominant patent, or failure to obtain FDA approval for use of the gene, or an injunction by a court against making the product of the invention, or national security related issues, for example.

DR. KRAUTHAMMER: Could you give an example of a patented human gene?

MS. HAUDA: Of a patented human gene?

DR. KRAUTHAMMER: Yes, just so we have some idea.

MS. HAUDA: Sure. An example of an actual gene that has been patented?


MS. HAUDA: Well, insulin and numerous cancer genes, such as the melanoma gene, has been patented.

DR. KRAUTHAMMER: Breast cancer genes?

MS. HAUDA: Yes, Broca-1 and Broca-2.

DR. KRAUTHAMMER: And if you wanted to do research on them, you have to have it licensed if you are going to even study it?

MS. HAUDA: There is a very narrow research exception, that if you are researching for non-commercial purposes, that would not be an infringement under the patent law. But if the research is for commercial purposes, then yes, you would need to get permission from the right-holder.

DR. KRAUTHAMMER: And if you wanted to develop a therapy different from the therapy produced by the patent holder, you would have to get a license from them; is that correct?

MS. HAUDA: Yes. If you want to work with that gene for purposes of commercializing and looking for a new therapy of that gene, you need to get permission from the right-holder.

But that is what allows the biotechnology industry to grow, is that relationship where it is beneficial both to the right-holder to license its gene out and get some benefit from his invention of what he is taught to use it for.

So it is not just the isolation. That person has taught a use for that gene, and the first person to isolate the gene and teach a use for it is the one that gets the grant to that gene.

Further research that wants to continue to use that gene in order to look for new therapeutic uses, for example, would need to get permission from the right-holder, who is the original person who isolated the gene and found a specific, substantial, and credible use for that gene.

PROF. SANDEL: Thank you.

PROF. KEVLES: I just wanted to ask for clarification on the research exemption. My understanding is that there is no statutory research exemption, and that this was an issue in the Kastenmeier hearings in 1987 and 1989.

That there is some common law precedent on specific cases for research exemptions, but that there is no blanket policy of research exemption that you can use something that is patented for basic research of a non-commercial nature; is that correct?

And is that is correct, where does the research exemption on genes come from?

MS. HAUDA: That is correct. There is no statutory research exemption that I am aware of, but there is case law that says a research exemption for non-commercial uses can non-infringement, and just —

PROF. KEVLES: It is not specific to genes?

MS. HAUDA: It is not specific to genes, no.

PROF. KEVLES: So if someone were doing basic research with it on a human gene, they would be vulnerable to action by the patent-holder, right?

MS. HAUDA: The patent holder certainly could bring an infringement suit, yes.

CHAIRMAN KASS: Robby George, then Janet.

DR. ROWLEY: I am directly related to this.

CHAIRMAN KASS: On this? Okay. Please.

DR. ROWLEY: Because at least in my own experience, and I am not sure whether Liz could comment as well, if you want to work on a gene or use a technology that has been developed by someone who owns or holds a patent on that, you can write for permission to use that and study it.

And you define how you want to use it and study, and then you get or there is an intellectual property agreement, a material transfer agreement, that you can sign. And it is signed between institutions. So the lawyers and the various institutions then will give you permission to work on it.

But many times those intellectual property transfers also do say in response to Mike's question that if you find some further use that was not included in the patent, that use then reverts to the person who made the original observation.

And sometimes these material transfer agreements can take months to achieve, and it is I think an impediment to free science. And I think that as a matter of fact there have been comments in Science Magazine and elsewhere on this very issue.

DR. FOSTER: Just one quick reminder from yesterday when Patricia Baird talked about the Breast Cancer I and Breast Cancer II gene in Canada, you will remember that they had an — well, they were required not only not to test for the gene in their own laboratories, but to send it to the laboratories of the patent holders for BCRA1 and BCRA2, with a marked increase in the cost.

Such that apparently Provence has decided that they cannot test women for this because of the expense.

PROF. KEVLES: I would just add to what Dr. Rowley said, that the situation is in some cases approaching paralysis, the paralyzing of research, and that the problem is compounded if the research being done in University A, which generates patented object or the material object, is supported by a biotech company, which will then have dibs on what the laboratory can do.

So you can imagine just the material transfer problem of arriving at an agreement when there is a corporate patron, a researcher in one university, and then the possibility of exactly the same in a second university.

CHAIRMAN KASS: We have run over. We started late due to a fault of the headquarters just on the starting time, and we have gone over and we have another panel.

Let me ask Robby George, who is on the list, if you want to comment, and then we will close this and take a break, and take the second panel. Robby, did you —

DR. GEORGE: I will waive it.

CHAIRMAN KASS: You will waive it? Okay. Since we are running late, let's keep it sharply to a 15 minute break. The second panel will convene, and then if our two guests now will stick around or can, we might at the very end if there is time bring you back and have a discussion with everybody included.

We will convene in 15 minutes, and thank you very much for the presentations.

(Whereupon, the meeting was recessed at 10:16 a.m., and resumed at 10:36 a.m.)

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