"The genes and cells and molecules of these organisms are in a deep sense products of nature, they are not inventions of individuals, corporations or institutions... The claim that the determination of the nucleotide sequence of the gene represents a novel invention is deeply specious and misrepresents profoundly the nature of genes and proteins and organisms. " - Prof Jonathan King, MIT
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Thanks to Luke Anderson for these Submissions (oral and written) made to the NZ Royal Commission . Some fascinating stuff, including in the exchanges after the oral submission.
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PATENTS ON LIFE
New Zealand Royal Commission on Genetic Engineering
Oral Submission by Jonathan King, Professor of Biology at the Massachusetts Institute of Technology, appearing by video link to Aukland, 16th February 2001
PROFESSOR KING: Well, good afternoon, I want to thank the distinguished members of the Commission for hearing my testimony. I'm sorry I was not able to be present in person, but I'd also like to applaud the Government and people of New Zealand for embarking on this process. I wish we had an equivalent process in the United States.
Please note that I speak as a working scientist intimately engaged in genetic engineering and biotechnology. My early scientific work contributed to the development of phage vectors for cloning technology and my current scientific work involves the use of genetic engineering to solve folding production problems for therapeutically important proteins.
The advances in molecular genetics biochemistry and cell biology provide extraordinary new possibilities for preventing and treating disease for a deeper understanding of the interaction with organisms with each other and their environment and for entirely new manufacturing technologies.
However, living organisms are self-reproducing; qualitatively different from all mechanical, electronic or other manufactured objects. The genetic modification of organisms therefore brings social environmental and health risks of a new type much deeper and more serious than previous pollution hazards. Despite the problems of pollution from heavy metals from polyaromatic hydrocarbons or petroleum spills, these noxious materials do not reproduce themselves in the environment. Even radioactive isotypes decay away. But organisms once inadvertently established are extremely difficult to call back. Here in New England this would include the Dutch Elm disease which killed off the Elm trees in New England, the chestnut blight which killed off the chestnut trees. In our Great Lakes the zebra mussels are displacing native species. Around the globe the HIV virus is killing people in nations around the world.
The breakthrough that allowed genetic engineering represents 50 years of public funding of biomedical research and agricultural research. This public investment was directed towards protecting human health, protecting food crops and alleviating the ravages of disease. The extraordinary rich and rapid progress of these discoveries flowed from explicit national policies, shared resources and open communications. This was true in the United States, in Great Britain, in Canada, in Australia, New Zealand, France, Netherlands, Denmark and other countries.
These extraordinary technologies, the reason we're here today in this forum, modern genetic engineering and biotechnology, took place outside the patent system. In fact it was precisely because life patents were not allowed prior to the Chakrabarty decision that scientists and citizens all over the world have success to the extraordinary technologies, amino acids sequences, protein biochemistry, cloning gene sequences, all the wonders of modern molecular biology.
Frederick Sanger from Britain's Medical Research Council who developed both the technology for determining the amino acid sequence in proteins and the first technologies in determining the nucleotide sequence of genes; he didn't patent those developments, he shared them with people all over the world, and you can find them in any lab in the North Island or the South Island. Jonas Salk developed a vaccine that was produced and delivered in millions of doses. His team was ambitious, but for recognition not for enrichment. He was the person who, when asked why didn't he patent his vaccine, he made the comment about, "he might as well patent the sun". That was the notion that these vaccines were inventions was fallacious. Now, the scientific and technical workers who built this foundation were engaged as public servants and the help of modern science and technology still depends on the ability to mobilise thousands of talented people to work to the public interest and not for profit gain.
Now, I want to speak more explicitly about the question of gene patents. The vast majority of the genes of all animals, plants and microorganisms on the surface of the earth have evolved over millions of years. The species that are most important to humans, horses, pigs, cattle, grasses, trees and tubers have evolved over hundreds of millions of years. The very small number of species that are the basis of human nutrition have been domesticated over the past 10,000 years; the husbandry and input of generations of humans all around the world.
The genes and cells and molecules of these organisms are in a deep sense products of nature, they are not inventions of individuals, corporations or institutions. Elements and minerals cannot be patented because they are found and discovered and not invented. The claim that the determination of the nucleotide sequence of the gene represents a novel invention is deeply specious and misrepresents profoundly the nature of genes and proteins and organisms.
But the fundamental issues that you're addressing are questions of social policy and not legal interpretation. Patent laws are passed, modified and abrogated by national parliaments just as other laws governing the country; they're a means for social progress, not an end in themselves. And, the granting of patents on gene sequences represents a very deep misuse of the patenting system and the kind of private exappropriation of the common biological heritage of all human beings. It is the equivalent with trying to privatise the ocean, or the atmosphere, or the moon. If allowed to continue it will become a major impediment to social, scientific, medical and agricultural progress.
Now, I'd like to comment on two aspects of patents. A patent, as you heard in your testimony, a patent allows the owner to exclude others from benefitting from the patent process of construct or matter. The patent holder can prevent other efforts to produce or utilise the invention even if for medical uses for human welfare. In fact it's precisely because patents allow you to suppress all competition to keep all other institutions out of the market, that's why they're so valuable to those corporations that hold them.
The mechanism of exclusion takes the form of infringement suits, injunctions against sales of products and other forms of litigation threatened or actual. Hundreds of millions of dollars worth of suits are brought regularly as corporations and even universities, other institutions, manoeuvre for control of the monopolies which follow from patent ownership.
Now, I'd like to clarify two further points; patent lawyers often speak with about how patents require the revealing of the information. In the area of modern biological research this profoundly misrepresents the actual use of patents. In the normal course of modern biological research, scientists are striving to publish and reveal their results; this is their stock and trade in currency. The intervention of the patent system reverses that.
Patent Law requires that the subject of the patent, if it's been previously been revealed, that is it becomes prior art, then the patent would be disallowed. Thus oral reports, abstracts, grant proposals, public papers all constitute prior art. As a result individuals or groups planning to file for a patent have to avoid public disclosure of their work prior to the filing of a patent claim. Patent attorneys regularly advise researchers to restrict their presentations to colleagues, don't show your work, don't show your notebook, don't give that talk, so as not to jeopardise the planned patent submissions.
This has reversed the half century culture of free and open communication in the scientific communities. It's quite chilling when you actually experience it. It's now common to go to a scientific meeting, you ask your colleague a question and you're told, well, he can't answer it, she can't answer it because there are intellectual rights issues that bear on the question. And of course in those cases they're telling you that, then you realise how many times the speaker is not telling you that they're withholding information because of patent, because of pending intellectual property rights. So it introduces a chilling secrecy where openness is essential, slowing and misdirecting biomedical and agricultural progress. (You had some testimony as a side issue from the Trade Union representative around the question of getting access to safety information, which is constrained because of the need to prevent publication prior to patenting.)
The second point I want to deal with is the way in which life patents retard the development of social use of technologies, not research but the actual technological development in agriculture and healthcare. The key commercial value of the patent is the ability to prevent competitors from developing or delivering a later superior product. I gave an example in my written testimony that the Biocyte Corporation will obtain the patent on the use of blood cells from the umbilical cord, and the medical community published an open letter protesting the granting of the patent because they were concerned that it would discourage and threaten nonprofit use of this technology. It's noteworthy that in India, Brazil and other countries patent laws excluded pharmaceutical and other healthcare products from patenting on the basis of protecting the public welfare.
I've served as an expert witness in one particular case in which a large US firm which had many patents on an important therapeutic protein involved in treating stroke and heart disease. A European firm had developed a much better form of the protein, more efficacious, and could help save more lives. The strategy of the patent holder was to use their patents to keep the competition from bringing their therapy to the market. They charged them with infringement, obtained injunctions in the US court against the marketing, litigated for years and successfully used the patents to keep the better drugs from coming to market; despite expert witnesses on the other side.
And, of course, if you read business journals and texts you will find that in that literature patents are described, not as advancing technology, but it's a mechanism of suppressing competition, keeping prices and profits high. Now, I suspect that there is a concern in New Zealand that in the absence of life patents New Zealand's natural resources, very rich and unique resources will not be developed, your scientific community will not thrive. On the contrary, I will suggest that this is the best course for you to follow to develop your resources widely in a fruitful manner. Almost certainly the giant global corporations like Monsanto, Novartis, Glaxo, do not have New Zealand's development high on their agenda.
Local scientists in your country will find themselves increasingly hemmed in by patents held by Monsanto, Novartis, Glaxo. They will, for example, develop a genetically modified cytochrome C in some plant. And, given the fact that cytochrome C in all organisms are very similar, the claim that the patent covers genetic modification of that gene in any plant for whatever purposes and increasing the utility of the plant; the creativity and dedication of your biological agricultural resources will almost certainly, as the years go by, be increasingly thwarted and hemmed in by the aggressive enforcement of broadly written patents by these trans-national corporations with very deep pockets and very large staffs of patent lawyers. Your own agribiotechnology efforts will be constrained or bought up and tied up.
On the other hand I noted in some of the testimony which I had the privilege of reading, I think again from the Trade Union representative and maybe others who testified before you, New Zealand has a distinct character as an island nation and it is one of the few nations that can probably convince the World's consumers that its products are free of genetically modified material. I think that the possibilities of commanding a market far more likely by taking that mode than by trying to compete in a global market where real concern for nutrition and productivity is very low.
I am at the end of my time. I want to point out that in most testimony concerning this extension of the patent system to living organisms, the United States experience has given us the example, in particular the Chakrabarty decision in 1980 in the US Supreme Court which allowed by a very narrow 5 to 4 decision the patenting of a genetically modified organisms. I want to point out to you that the United States Congress has never publicly discussed this issue, there have never been public hearings in the United States held by the United States Congress. The extension of that decision to first genetically modify genes and then to naturally occurring genes, was done by the Patent Office under pressure from the biotechnology and pharmaceutical industry, and I believe that these decisions, as the general public and the scientific community becomes aware of how broadly these impact on our society, that we're going to see in nations, as we already have seen all over the world, opposition to these - this very unsound policy, and that you will not be alone in taking your position against it.
I haven't talked about the connection between patenting and safety of genetically modified crops. They're directly coupled; the reason that firms like Monsanto have pushed ahead so rapidly, lacking any basic safety information, lacking any basic - the real kind of years and years of field trials that you need, the years and years of product safety and nutrition testing, is because the ability to patent these genetically modified plants gives them a monopoly position that they do not have with respect to naturally occurring varieties.
And so they have moved full speed ahead to capitalise this. Roundup Ready soybeans make no contribution to human nutrition, it doesn't make any contribution to the farmer, it makes contribution to Monsanto's ability to continue to sell Roundup. There's no social, agricultural, nutritional reason to have millions of acres planted with those crops. It's driven by the fact that the monopoly position given by the gene patents allows a business advantage which is very different than an agricultural advance.
MS HOWARD: Professor King, I'm sorry to interrupt you, you're out of time.
PROFESSOR KING: Thank you for giving me the opportunity to testify, I'm happy to answer any questions.
MR HODSON QC: Professor King, my name is Hodson and I'm a barrister, counsel, retained by the Life Sciences Network and you will probably be stressed to hear that in that context Monsanto, Aventis and people like that are amongst my clients. So, having made that clear there are just a couple of topics I want to ask you about. If the private sector isn't able to patent a particular discovery that it feels it's able to make, isn't that going to affect its interest in investing in that discovery?
PROFESSOR KING: Well, there's no doubt that the patents, because they increased the ability to have a monopoly position, they provide an advantage in terms of prices and profits. On the other hand, the notion that these firms will go out of business or they won't be able to sell their products, has no basis in fact. Many many major corporations in the world, you know, from beer brewers to auto manufacturers sell their product, not because they have patent monopolies, but because they do a better job on producing; they produce a better product or they deliver it at a lower cost. So, I do not believe that the biotechnology, that the pharmaceutical industry, would disappear in the absence of patents. Their greater profitability in the United States that are the most profitable corporate sector, may go down, but it will just open up the field to competition. In the case that I described to you, the firms that I was representing had a much better product and they were willing to market it without a patent monopoly. They knew there were hundreds of thousands of people out there who would pay a fair price for it. So, I believe that the ability to attract venture capital, those people who are looking for a one hundred to one investment, yes, that will shrink, but venture capitalism is not the only way of developing commercially viable products.
MR HODSON QC: We have a rather different economy down here. We don't have the enormous multinationals and we don't have the very great foundations that the United States has the advantage of, so that if the private sector here is discouraged, what one does in this country is look to the Government, and I have to tell you that in this country that's not a very good look. The point here is that if we in New Zealand restrict patenting when countries such as the USA carry on the present practice, aren't we rather cutting off our nose to spite our face?
PROFESSOR KING: I sincerely doubt that your native industry would be able to protect their patents against the giants that they're in competition with. As you know, patenting doesn't have very much to do with who's right - I mean, there's a very long protracted legal process, litigations are usual - and very often the victory goes to the one who can, you know, who can stay in the battle with deepest pockets. I find it very difficult to imagine that, if you tried to establish a patent position around a product that had a world market, that you'd be able to defend it. I think you're far better off declaring New Zealand a patent-free zone.
MR HODSON QC: Thank you for the thought; we had managed it in some spheres. I have in my hand a book, and I regret that I'm not able to show it to you now in any meaningful sense; it's a publication by the International Service for the Acquisition for Agribiotech Applications, ISAAA. Are you familiar with that institution?
PROFESSOR KING: No.
MR HODSON QC: Well, it's an international research organisation, and this particular book is financed by the Rockefeller Foundation which you will understand when I tell you that the title of the brief is The Intellectual and Technical Property Components of Provitamin A Rice; in other words, Golden A rice. You are familiar with Golden A - golden rice?
PROFESSOR KING: Yes.
MR HODSON QC: Essentially, the situation there is that a very large number of patents were combined, free of charge I think largely by the owners, in order that this particular product had become possible.
PROFESSOR KING: Well, you know, I would have thought that that example would have been brought in on the other side. Agricultural scientists all over the world, in almost every nation of the world, understand the importance of rice in human nutrition. They also understand the importance of learning about the genes that control the rice plant determining the sequences of those genes. So, determining the sequence of rice genes and learning about rice genes, there's nothing novel about that, that's what agricultural scientists are doing all over the world.
To have a situation where one company owns the patents on rice, which is a crop that developed out of the nurturance of, you know, thousands of years of culture in Asia and the Middle East and other parts of the world, you know, that is doing much more to slow down. All the packaging that they had to do to put together that situation, they would have been able to proceed much much more rapidly if the patents hadn't gotten in the way of developing of the strains. Believe me, patents had nothing to do with developing of Vitamin A rich rice. The rice doesn't have enough Vitamin A to actually have any impact on nutrition whatsoever. You know, it wasn't - there's nothing particularly
MR HODSON QC: Professor, we've had a lot of discussion about the rice, and I think I know what it is.
DR DOREEN STABINSKY: If I may add a comment here; I think you've slightly misrepresented this ISAAA report.
MR HODSON QC: Please correct me.
DR STABINSKY: In the introduction to the report it actually says that there is approximately 70 patents, and I believe 36 other types of intellectual property protection on the components of the Vitamin A rice. And in fact the intellectual property of all of those patents, that they're owned by a wide variety of companies involved, and in fact freedom to operate, the freedom to utilise the inventions patented has not been negotiated. And in fact the report outlines six different options for actually dealing with these intellectual property constructs once Vitamin A rice were to be marketed, were to be commercialised. And, in fact, one of the options that's presented in this report is the option number four, to ignore all intellectual property. That, in fact, these patents are a severe constraint on, in fact, the International Rice Research Institute to be able to eventually release Vitamin A rice, and they haven't been resolved, and that's why the Rockefeller Foundation commissioned this report to try and see what options were available to deal with this incredible tie-up of Vitamin A rice by all of these different intellectual property committees.
MR HODSON QC: I think that's absolutely right, if I may say so. But the end result, as I understand it, and we've had some evidence abut this, is that Professor Potrykus has found it necessary to take out patents of his own. I table this, sir, just to point out the intricacies of the subject. No more questions.
PROFESSOR KING: Can I point out that one way of protecting a discovery is to patent it; the other way to protect it is to publish it, because once it's out in the public domain it can't be patented and privatised. Once again, the race for the human genome, the public consortium, they publish their results as soon as possible because, the moment it's in the public domain no corporation or institution or individual can patent it and, therefore, restrict it. So, that still is absolutely a superior way of protecting access to information, is to make it available, to put it in the public domain.
MR UPTON: Professor, my name's John Upton and I should be about right in front of you in the bottom right-hand corner of your screen. I'm Counsel Assisting the Royal Commission and I've just got some general questions that I want to talk to you about. As professor of molecular biology at the MIT, are you allowed to personally patent discoveries that you might make, or do you assign that right over to the school?
PROFESSOR KING: It's some kind of sharing arrangement. Since I myself do not - have not applied for patents on my own work, I'm not intimately familiar with the arrangement. But the arrangement is that you're an owner of the patent and it's kind of jointly shared with the institute.
MR UPTON: It's just that -
PROFESSOR KING: If there's royalties, they're shared.
MR UPTON: Sure. It's just that in New Zealand as I understand it scientists working in our Crown Research Institutes assign their rights across to their employer, so the rights then belong to their employer to patent and I just wondered if it was a similar structure; obviously it isn't.
PROFESSOR KING: In the US, that is the situation with US corporations when you work in a corporation - my students who work in corporations, when they're working on material that there will be patent claims on it, those will be owned by the company and not by the individual. But in the university environment it's a little different.
MR UPTON: Thank you.
PROFESSOR KING: So, this varies from university to university. In the United States, it's not uniform across the - it's not national policy, it's local policy.
MR UPTON: Thank you. Does your department get funding from corporates?
PROFESSOR KING: Yes. I get funding from corporations; whose policies I don't agree with.
MR UPTON: Fine. It's an issue which has come up for discussion on several occasions before the Royal Commission. How do you preserve your integrity, if I can put it bluntly?
PROFESSOR KING: Well, you know, I have been involved with these issues since the original Chakrabarty case, I testified the first - the Federal Government that - well, the first hearings that existed on these subjects. I have long involvement around public policy but I'm also, I make my living as a researcher. And of course, one of the things about these corporate grants is they make life extremely difficult for, in some ways for an honest scientist because, if you view your contribution as you're going to develop knowledge, in my case on protein folding that's available to the World's community, and then you have a contract that says that you can't publish, you can't reveal - you can't report the results without getting the "okay" from the company, you're very sharply constrained. That's a major problem in terms of the education of graduate students where you're trying to educate them to become national servants, get the support on contracts that are corporate contracts. So, that is a real struggle, and the introduction of the ability to patent these inventions made it much worse because then individuals could personally profit from keeping their discoveries essentially private. So, in my experience, which is considerable with these corporate grants, they enrich the individual and they damage the nation. That's in my case. My laboratory, I won't name the company, but we do contract research, we have a contract with them; it's important research for them, we're able to do it extremely well. It would be much better if it was funded from the public sector.
MR UPTON: But if you get funding from -
PROFESSOR KING: And the great advances in the United States were because of the enormous public investment, because of the free and open communication. We wouldn't have genetic engineering technology if it wasn't that all of the people who made the key discoveries revealed them to the general scientific community. That's why in New Zealand your scientists can clone genes and sequence genes and introduce them from one cell to the other, because the founders of the field did it as a service to the whole human community, they did not privatise it.
MR UPTON: When you get funding from a corporate, do they tell you what areas you're to use that funding in, or do they leave it to you? In other words
PROFESSOR KING: It's quite closely specified.
MR UPTON: Do you ever find -
PROFESSOR KING: And nor can we report our results without permission.
MR UPTON: And do you ever find that you're in difficulty because of tags on the funding?
PROFESSOR KING: Oh, yes. Yes.
MR UPTON: How do you deal with those difficulties in practical terms? Do you tell them to take the cheque back?
PROFESSOR KING: In many cases we decline - we decline to accept these contracts. I can think of many cases where there are areas of research where I thought that - it wasn't just a question of being restricted from public discussion, it was that there were real safety and, you know, dangerous - there were issues of safety considerations and things that were unsound directions, and so you declined to do that. But, once you are in a patent - once patenting is established, as is the current situation in the United States even though it's an intense debate, you're under pressure to proceed in that, you know, in that direction, you're constrained as everybody else is constrained.
It's very difficult - it's difficult for the individual, but it also, it retards the development of the field. In the area that I work, which involves solving - one of the things that I actually work on is solving protein production problems in the biotechnology industry, and many firms file for patents on these tech advances, they don't share it with other firms, and these problems which could be solved easily if this stayed in the public domain, are solved much more slowly because of each company trying to establish a patent position around this particular application of certain technologies.
MR UPTON: Do you have protocols in place which deal with issues that arise out of funding by corporates, or do you deal with any problems on a case-by-case basis?
PROFESSOR KING: We don't sit - the kind of - this kind of debate right now, where you have a Commission, it's formally put in place by the Government, it has some kind of public presence and public credibility, we do not have that debate in the United States, right. I am very knowledgeable on this subject, my department has never asked me to speak publicly in the department on this issue, this is a very controversial issue, they're trying to get contracts from these various biotechnology corporations who are trying to get patent monopolies, there's no encouragement of a public debate. Students will occasionally invite me to speak on the subject. The episcopal chaplaincy will invite me or other people to speak on the subject. But we are not yet able to have an open discussion on these ethical problems.
MR UPTON: Perhaps I didn't make myself clear, but I was asking whether you actually have formal protocols which allow you to deal with issues arising from funding by corporates of the sorts of work you are doing, or whether you deal with those problems on a case-by-case basis as and when they arise.
PROFESSOR KING: It's on a case-by-case basis.
MR UPTON: Thank you very much.
CHAIR: Professor, I apologise if I have misunderstood the thrust of your questions, of your submissions, but it seemed to me that many of the arguments that you advanced applied to patents generally rather than specifically to patents relating to life forms. Would you comment on that?
PROFESSOR KING: Excuse me, could you repeat the question please? There was some interference.
CHAIR: Yes. I said, it seemed to me that many of the arguments that you advanced in your presentation applied to patents generally rather than specifically to patents on life forms. Have I misunderstood you.
PROFESSOR KING: Well, I'm not - you know, I'm - my experience is in the world of biology and genetic engineering and that's where I have, you know, paid very close attention, been surrounded by the development of the events, and that's where I feel I can speak, you know, with experience and knowledge. In the realm of mechanical devices, I don't have direct experience. I know there are many people who share - who have the same views that I have, that would say the same things around mechanical inventions that patents have - has often been the mechanism to support innovation. But I myself am only knowledgeable in the area of biology and, of course, for hundreds of years - for many many hundreds of years living organisms were excluded from the patent system. You know, in the United States the patent laws were written under the supervision of Thomas Jefferson, our first Secretary of State. He was a plant breeder, he was intimately aware of the commerce in ornamental and other plants, but he excluded living creatures from the patent laws. I believe, you know, on the grounds that they weren't inventions but secondly they were just too important to be left to become private property.
CHAIR: Now, I understand that, but it seems to me -
PROFESSOR KING: He was all for patents of waterwheels and windmills, he held those patents; he just didn't believe that patents laws should be extended to agriculturally important developments.
CHAIR: It seems to me that, if you argue on grounds that the patent on life forms stifles research, that it stifles public access to the results of the research, and that it aggregates powers in the hands of a few companies, it did seem to me that all those arguments could equally be applied to patents on anything at all.
PROFESSOR KING: That may be, but that was not my - my testimony is -comes from investigating these situations with respect to biomedical research which is a creature of the 20th Century, right, maybe a little earlier, right, and grew up in an environment that didn't exist earlier in history where the major activities were publicly financed, and it wasn't individual gentlemen, you know, in the Royal Society who were carrying out its various experiments by Benjamin Franklin in Philadelphia, it was a social institution. All of my education, my training, my postdoctoral work, all the research and all the people I've trained for 30 years, it's all dependent on the fact that there was a national policy to advance biomedical knowledge for the general public good, and that's the context in which gene sequence has come into human history.
CHAIR: Do you think cost of research has got something to do with it? We hear figures of many billions of dollars required to develop many of these technology advances of today. It's a very -
KING: One thing that's very clear that a significant fraction of that is paid to patent lawyers working on development of the patent claims. I don't believe that that's true. It's expensive -no, I don't believe that - I don't believe it's true that it costs billions of dollars to develop, you know, a better strain of cassava if you're not trying to get a private monopoly over it.
CHAIR: Thank you.
PROFESSOR KING: Because you have access to all of the World's research in that area. Your New Zealand scientists don't have to re-expend the billions of dollars spent in Great Britain on working out the structures of proteins. All of that technology has been made freely available to them. The crystallographers in Christchurch has to sit on 50 years of public - of shared knowledge and technological development; the proposal of the biotechnology industry that we've reached a point in history where, unless we privatise, this progress will be thwarted, the thrust of my testimony is that the truth is just the opposite. Is that, if we want to unleash the benefit of the technology - these technologies for our peoples, we have to resist this effort to privatise, which will have just the opposite effect; and all you have to do is to pick up the Science and Nature and read all these examples of infringement suits and companies suing another company, companies suing research scientists. If I had more time I would give you many examples of my own research where we're unable to move forward because people won't share information because they're going to patent it and privatise it.
DR ALLAN: Professor King, I'm Dr Alan. There's this issue that the patents expire after 20 years. One of the comments that we have heard is that some of the enabling technologies which have patents on them have been taken out so early that the companies who own the patents might not get a return in those 20 years when that technology becomes a part of the public domain. Could you comment on that?
PROFESSOR KING: Well, you know, large companies with big patent holdings, they have very sophisticated strategies. You can learn about them at our Sloan School of Management, where I'm sure you can probably learn about it better at a Business School in New Zealand. They're very sophisticated strategies. In the drug industry, for example, a year or two before the patents on some antibiotic is going to expire, they'll bring out a version just sufficiently modified so that they can get a new patent granted on that one that extends for another 20 years, and then they put all their advertising dollars into supporting the new product to try to keep the same market. There are many such crisis. That doesn't meant that genetic modification -
DR ALLAN: Doctor King, I'm a doctor -
PROFESSOR KING: -- that what you describe -
DR ALLAN: I'm very aware of generic medicines, I think New Zealand has some conflicts with some of the biotechnology firms over our use of generic medicines to reduce the drug bill. But separate than that the question is, these enabling technologies will then enter the public domain and we're talking about enabling technologies rather than particularly processes that - particularly products at the end of it, they're processes rather than products. Won't those processes then be available to everybody after 20 years?
PROFESSOR KING: Some of them will be. Of course, after 20 years often they're, you know, somewhat obsolete and they're no longer enabling technologies. Yes, after 20 years certain of these patent technologies will move, they lose patent protection and they become more available. And you often see a burst of activity around that because the suppression of competition has been lifted. But 20 years can be a long time.
DR ALLAN: But what is the alternative that the corporation that develops a technology keeps it secret? We've got the awful example in medicine we're very aware of, is the invention of the forceps that was used to save a lot of lives among women in birth was kept secret for over 30 years by a father and son team of obstetricians. And, because there was no way of patenting it and them deriving any income from it, and they actually kept it secret and you could say they actually might have made income out of it but it led to the deaths, needlessly of a lot of women at a time when cesarean sections weren't an alternative.
PROFESSOR KING: Well, I think for every example like that there are 50 examples of the other kind. Keeping - that implies that creativity is extremely narrowly distributed in human society, that only the company that has developed the secret has the capacity to develop this knowledge. Now, when you're talking about biological knowledge or, for example, gene sequences, you know, if some company keeps the sequence of my active gene from my muscle actin, you know, I guarantee you there are 1500 researchers who will isolate the gene, determine the sequence, and some of them will publish it. So, secrecy does not prevent other people from proceeding. Also if you're actually going to market a product, it's very hard to keep it secret because people can get access to it. So there are actually very very few examples in the literature where corporate secrecy prevented the development of the technology because the competitors just proceeded. There's a fundamental difference between a patent which allows you to keep other groups from developing the technology and a secret which doesn't keep other people, I was recently at a symposium where a physician from the University of Pennsylvania described - they were trying to provide certain services, genetic screening services for their patient population and they received letters from a number of companies that owned the patents on the genes charging them with infringement, right. It wasn't - if those companies had kept the technologies themselves, the University of Pennsylvania scientists would have had no problem developing it independently. So, I don't believe those are equivalent - they're not equivalent phenomena in society.
DR ALLAN: Thank you Professor King.
CHAIR: Thank you very much Professor King for joining us, our time is now run out, so we're going to close this session but we do appreciate the contribution you have made.
PROFESSOR KING: Thank you, and I look forward to reading your further deliberations.
CHAIR: Thank you very much.
Written Submission
My name is Jonathan King and I am Professor of Molecular Biology at the MassachusettsInstitute of Technology where I have taught and led a research team in molecular genetics for 30 years. I am an author of more than 150 scientific papers on how genes control the folding andstructure of proteins. I am immediate past-president of the Biophysical Society, which representsalmost 6,000 working scientists in the United States and abroad. My professional experience also includes serving and chairing committees of the US National Institutes of Health dispensing research grants to US scientists. I have also served as an expert witness in patent disputes between biotechnology companies. In addition I serve as member of the Board of the Council for Responsible Genetics, an advocacy group for citizen participation in biotechnology policy formation. I have been called by Greenpeace New Zealand to testify to Royal Commission on the consequences of the patentability of genetic material.
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The genomes of human beings as well as those of agriculturally valuable plants and animals are rapidly being converted to private and corporate property through the radical extension of patent laws to biological entities. This constitutes private expropriation of the common biological heritage of human societies. It will retard research, limit the development and delivery of medical care, and lead to concentration of monopolies within agricultural and biotech industries. With the pressure through WTO and global corporation, there is significant danger than invaluable and irreplaceable natural resources will be limited by corporations exercising their patent monopolies.
Historically patents have been used to exclude others from using the patented information. In the area ofbiotechnology, such patent monopolies are used both to suppress competition, and to suppress the development of better or cheaper products. This is the major reason for the commercial push to replace natural varieties by genetically engineered and patented varieties, in the absence of adequate ecological, nutritional, or toxicity testing. The people and Government of New Zealand should resist this privatization of their biological heritage and exclude gene sequences cell lines, and organisms from patenting.
The genomes of human beings as well as those of agriculturally valuable plants and animals are rapidly being converted to private and corporate property through the radical extension of patent laws to biological entities. This constitutes private expropriation of the common biological heritage of human societies. It will retard research, limit the development and delivery of medical care, and lead to concentration of monopolies within agricultural and biotech industries. With the pressure through WTO and global corporations, there is significant danger that invaluable and irreplaceable natural resources will be limited by corporations exercising their patent monopolies.
The emergence of the biotechnology revolution is a defining aspect of the beginning of the new millennium. Breakthroughs in molecular genetics and cell biology offer new opportunities for preventing and treating disease, for a deeper understanding of the interactions of organisms with their environments, and for entirely new manufacturing technologies. Intertwined with this emergence of biotechnology has been its very rapid commercialization.
An unforeseen and deeply troubling aspect of this commercialization is the transformation ofbiological entities - products of hundreds of millions of years of evolution - into private property. This is taking place through the radical extension of patent law to encompass gene sequences, cell lines, genetically modified organisms and even natural species. These policies represent a radical change in the relations between human societies and biological species and resources.
Rapid Privatization of Genetic Resources:
The transformation of the common biological heritage - for example the human genome - into corporate property through patent monopolies is proceeding without social oversight or democratic input. Within the United States the Congress has avoided any public discussions or hearings or legislative action on these issues of enormous scientific, social and economic significance. Thus discussions such as those being carried out in New Zealand are of global importance
The rapidity and range of this privatization is only just entering public consciousness. Myriad Genetics owns patents on the human genes damaged in breast cancer; Human Genome Sciences has patented the entire genomes of important bacterial pathogens affecting public health; Celera has applied for patents on thousands of fragments of sequences of human genes. The "race" between the public and corporate efforts to sequence human genes is whether human gene sequences will be in the public domain, or will be expropriated as corporate property through the granting of gene patents. Gene Sequences are Products of Nature, not Human Inventions
Gene Sequences are Products of Nature, not Human Inventions:
Our genes have been passed down to us from our parents and grandparents and hundreds of previous generations. The revealing of their sequences is enormously useful, but does not constitute a process of invention. The genes of organisms are products or organic evolution. In the language of patent law, they are products of nature, not products of invention, and thus rightfully outside the patent system.
Products of nature have historically been excluded from patent protection. Thus elements and minerals cannot be patented because they are found or discovered, and not invented. As a biologist I am appalled at the claims that the determination of the nucleotide sequence of a gene represents a novel invention. The historically evolved sequences of human genes are as clear an example of products of nature as minerals. Permitting patents on gene sequences is equivalent to granting patents on graphite to those who determined that the components of graphite were carbon atoms, or granting patents on the ocean bottom to those who determined its topology by echo ranging.
Claims of some patent lawyers or biotech firms that the patents are on isolated DNA sequences removed from the organism are specious. The fundamental nature of information is that it is independent of its material form. The value of sequences is their information content, and patents on them are used to prevent others from utilizing this information in whatever form.
From Common Heritage to Corporate Ownership:
Life patents on genetically modified cells and organisms represent a sharp departure from the historical traditions of human societies. Farmers have always owned the crops they grew, but they had no legal rights to restrict others from growing those crops. The Monsanto patent on transgenic cotton extends to all the progeny of such plants and allows Monsanto to prevent farmers from saving the seed of crops they have grown and planting them the next season. The cloning of Dolly was not announced until the Roslin Institute had filed patents not just for cloned sheep, but for all animals produced anywhere in the world by a similar process. The patent claims being filed within the US on the genes of humans, sheep or corn are being enforced on a worldwide scale. They expropriate the common heritage of New Zealanders and humans every where. Such private expropriation of fundamental biological resources reflects aqualitative change in access to basic biological knowledge and to the relations between humansociety and the natural world.
Since the US Government through the GATT and TRIPS processes has aggressively promoted a version of US patent laws as an international standard, I will comment on these laws. In theUS patent laws were written under the supervision of Thomas Jefferson when he was our first Secretary of State under Washington. Jefferson was an active plant breeder and corresponded with leading breeders in Europe. Nonetheless, the patent laws as developed by him excluded animals and plants from their coverage. Jefferson was clear that patents were a form of monopoly. He believed the role of patents lay not in the generalized protection of private property, but in the limited and specific purpose of ensuring that creative and inventive individuals were able to make a living, and thus continue to contribute to society. He wrote to John Adams that whenever this monopoly was contrary to the public interest, the public interest would take precedence.
With the commercialization of plant breeding and seed production in the 1920's, breeders attempted to restrict competition through inclusion of ornamental plants and other hybrids under the patent laws. Resistance from consumer groups and farmers prevented this, but breeders were granted some "protection" by the U.S. Congress through the passage of separate legislation, the Plant Variety Protection Acts. Organisms in general and their genes, proteins, or component cell lines, remained excluded from general patent monopolies.
This two hundred-year-old legacy was breached in 1980 with the granting of a patent for a genetically engineered bacterium by the US Supreme Court in Chakrabarty vs. US Patent and Trademark Office. The decision was a very close five to four decision and was narrowly constructed with respect to genetically modified microorganisms. In the years following, under pressure from the pharmaceutical, biotech and agricultural interests, the PTO began issuing patents on genes, human cell lines and plant strains. US corporate interests have used the vehicleof GATT and the World Trade Organization to aggressively press for enforcement of life patents by other nations in the form of the TRIPS section (Trade Related Intellectual Propertyrights).
However, the fundamental issues are questions of social policy and not legal interpretation. The Constitution simply states that the Congress shall have the power to "to promote the sciences and useful arts". Patent laws are passed, modified and abrogated by the Congress just as other laws governing the country.
The biotechnology revolution was the product of a broad-based biomedical research and training enterprise based in colleges, universities and medical schools throughout the nation. Essential to these efforts were the free communication and exchange of materials and ideas, and the organization of research in the public interest. Major scientific advances, such as the determination of the amino acid sequences that made up protein chains, were openly communicated and entered the public domain. The enormous inventiveness during this period occurred without patents.
The sequencing technologies used to reveal gene sequences were the products of decades of public investment in biomedical research. The basic discoveries that lead to the revealing of gene sequences occurred without patents. They were work of biomedical researchers motivated by the desire for recognition of their contribution to for improving health and welfare rather than fiscal gain.
Gene Patents Retard Biomedical and Agricultural Research:
Patent law requires that the subject of the patent have not been revealed as "prior art". Oral reports, abstracts, grant proposals and published papers all constitute prior art. Thus individuals or groups planning to file for a patent have to avoid public disclosure of the work prior to the filing of the patent claim. Patent attorneys regularly advise researchers to restrict presentations to colleagues, so as not to jeopardize planned patent submissions.
The resulting undermining and reversal of the biomedical culture of open communication and exchange is one of the most destructive impacts of gene patents.
Gene Patents retard the Development and delivery of Health Care:
In the health care field patents not only retard progress at the level of research, but interfere with the delivery of health care. The key commercial value of a patent is the ability to prevent competitors from developing or delivering a related (or superior) process or product and this holds for public and non profit institutions as well as other companies.
Thus when the Biocyte Corporation obtained a patent on the use of blood cells from the umbilical cord in a variety of therapeutic situations, health care professionals responded
"We join in protesting the granting of this patent to Biocyte corporation. We are also concerned that this patent may discourage and threaten activities of non-profit cord blood banks, clinicians, patients, parents and the volunteers who support them. (Nature, 383, 17, 1996)."
It is noteworthy that in India, Brazil and other countries patent laws excluded pharmaceutical and other health care products from patenting, on the basis of protecting the public welfare.
Life Patents Undermine rather than Advance Progress in Agriculture:
One of the most damaging uses of gene patents is their extension to genetically modified plantsand their seeds. Intellectual property rights on seeds deprive farmers of free access to anessential public good -- crop seed. Farmers for millennia saved the seed of their harvests for replanting the following year, and continue to do so even in the industrialized agricultural systems of the United States. Patents on seeds are a legal means to make sure farmers buy seedevery year; Monsanto took legal action against hundreds of farmers last year for planting savedseed from their genetically engineered varieties. Monopoly control in an oligopolistic market is asure recipe for higher seed costs.
Corporate spokespeople claim that, without patent protection, important technologies will not be developed. In fact, what patent protection ensures is not technological development, butsuppression of competition. Patents are as often used to prevent the development of newtechnologies as to exploit them. Some of these barriers have recently been explored by Hellerand Eisenberg (Science, Vol. 280, 1 May 1998, pp. 698-70) In the pharmaceutical and biotechnology industries patents as a mechanism of monopoly pricing rather than technology development.
The European Parliament, responding to the initiatives of the Green Parties, refused to acceptpatents on genes. Only the full mobilization of commercial interests in 1997 led to the set backof this effort. Just recently the Dutch Government formally appealed one of the decisions favouring gene patents to the European Court of Justice.
In Europe, Southeast Asia and South America, there are significant social movements opposing gene patents. Dramatic public demonstrations occurred in India in response to W. R. Grace's obtaining patents on the Neem tree, and these were followed by a vigorous battle in the India's upper parliament to resist the GATT intellectual property requirements.
The United Nations has recognized the necessity of protecting essential common resources from national sovereignty or private ownership. These include the oceans, the atmosphere, and the moon; the earth's life forms need to be in the same category. The next steps with respect to genes and other biological entities is for national Parliaments to clarify their national policy and exclude genes and other biologically evolved entities from patenting. At a later stage this will need to be codified by the United Nations.
To quote the 1995 Blue Mountain Statement:
"The plants, animals, and microorganisms comprising life on earth are part of the natural world into which we were all born. The conversion of these species, their molecules or parts into corporate property through patent monopolies is counter to the interests of the peoples of this country and of the world.
No individual, institution, or corporation should be able to claim ownership over species or varieties of living organisms. Nor should they be able to hold patents on organs, cells, genes or proteins, whether naturally occurring, genetically altered or otherwise modified."*
* The Blue Mountain Declaration, June 1995, is an extension of a presentation at the Annual Meeting of American Association for the Advancement of Science in Philadelphia, Pennsylvania. It was signed by groups in the US and Canada, including Alternative Agricultural Projects (AS-PTA) (Brazil), The Canadian Environmental Law Association, The Council for Responsible Genetics, The Culteral Conservancy, The General Board of Church and Society of the United Methodist Church, The Institute for Agriculture and Trade Policy, Biotechnology Action Council, and subsequently had published versions in US journals, the Congressional Quarterly (Washington D.C) and California Lawyer (San Francisco, CA).