Jonathan King is Professor of Molecular Biology at MIT. Doreen Stabinsky is Assistant
Professor of Environmental Studies at California State University at Sacramento. Both are
members of the Board of Directors of the Council for Responsible Genetics
and Co-Chairs of
the Science and Technology Committee of the newly formed Labor Party in the US.
Human society is currently passing from the end of the industrial revolution to the first stages of the technological revolution. One clear expression of this transformation is the leap in electronics and computer technology which is revolutionising both production and communication.1 A second expression is the emergence of biotechnology as a major factor in pharmaceutical and agricultural production.2 Biotechnology represents a) a new manufacturing technology for commodities previously available only by isolation from plants, animals or microbes, and b) the means to modify the genomes of living organisms so that the changes are propagated in subsequent generations. This vast acceleration of organic evolution has the potential to generate qualitative changes in the Earth's organisms and their interactions with each other and the ecosystem. The same technology applied to the human species can be used to modify the genome of humans, the aspect that frequently dominates news stories and popular imagination.
A less visible, but equally profound and disturbing, feature of the biotechnology revolution is its coupling to the corporate expropriation of agriculturally important plant and animal species: the extension of private ownership from individuals of the species, to all organisms of that type. Thus, Monsanto has US patents on all genetically modified cotton plants and all their progeny and, in Europe, patents for all genetically modified cotton and soybean plants.3 The patents held by Myriad Pharmaceutical in California on genes damaged in breast cancer cover those genes derived from any and every human being. The patents filed by the Roslin Institute, which financed the cloning of Dolly the sheep, extend to all mammals produced anywhere by a similar cloning process. A United States firm, Rice-Tec, Inc., has recently been granted a patent (US patent #5,663,484) on basmati rice that is grown anywhere in the western hemisphere.
This privatisation of organisms and their progeny poses a new class of dangers to the world food supply. Similar factors underlie the rising costs of the new drugs and therapies that derive from the integration of biotechnology into the pharmaceutical industry.4 A number of important recent books explore the background of these changes including Vandana Shiva's Biopiracy, Sheldon Krimsky's Biotechnics and Society, Krimsky and Wrubel's Agricultural Biotechnology and the Environment, Ruth Hubbard's Exploding the Gene Myth and Jeremy Rifkin's The Biotech Century.5
The application of biotechnology under fully democratic social and economic conditions would permit significant increases in productivity of food and other commodities, as well as major advances in the diagnosis of disease and the development of new therapeutic regimes. Unfortunately, the impact of biotechnology in the globalised capitalist economy is unlikely to realise this potential. Pharmaceutical, agricultural and biotech firms are moving aggressively, under the guise of free trade agreements, to privatise human animal and plant genomes, useful cell lines and agriculturally important crop plants and livestock. This effort to privatise life forms through the extension of patent protection represents a qualitatively new form of the private appropriation of social resources. The resulting distortions of agricultural and health care development are likely to bring the world's peoples increased risk to habitat, health and food supply.
Goodman and Redclift have described clearly the inability of British capital to establish industrial organisation patterns of ownership and exploitation in primary agricultural production.7 The uncertainties of biological and ecological processes, which depend on variables outside of industrial control---weather, disease and drought---made it very difficult reliably to extract surplus value from the growth of crops. In addition, it was difficult to control and limit production by others, given the widespread dissemination of agricultural knowledge and increasing acreage of arable land, both in the UK and abroad. By the 1870s, large capitalists had begun divesting themselves of the attempt to extract profit from agricultural production, and concentrated on processing, transport and marketing aspects.
For the world's major crops, whether rice, corn, wheat, potato or cassava, primary production is still carried on by large numbers of small producers. Even in the fully industrialised US grain belt, the large commodity trading corporations such as Archer Daniels Midland or Cargill have stayed away from owning the farms directly.
This inability to industrialise primary production remains true in the most vertically integrated sector of the agricultural economy, livestock production. Although a very small number of corporations control the feedlots, slaughterhouses, processing, packaging and distribution, they eschew ownership of the steers on the hoof or the chickens in the bins.
Thus, at present, despite global grain, corn, beef and fruit markets, primary agricultural production pattern is not dominated by large corporations. One consequence of this maintenance of food production (as opposed to processing and distribution) outside of monopoly ownership has been the inability of corporate grouping to raise the price of food crops as a source of super-profits. Much more frequent has been collusion in keeping prices paid to the farmer low for both crops and livestock. Goodman and Redclift argue that food prices have historically been kept down as a means of maintaining social stability, keeping pressure off wages of industrial workers, in part through state intervention in support of agricultural production.8
New efforts to privatise primary ownership of agriculturally important plants and animals are now underway as a consequence of the biotech revolution. The current privatisation of crop species themselves and prospects of monopoly control of food production are taking place through the integration of seed companies, agrochemical industries, and pharmaceutical and biotechnology companies, supported by radical changes in patent laws in the United States and the international extension of US-style intellectual property protection through the General Agreement on Tariffs and Trade (GATT) and the recently formed World Trade Organization (WTO). Though these changes are enabled by the advances of biotechnology, they follow from the capitalist organisation of food production in a globalised economy, and not from any technological or scientific imperative.
The information stored in genes is in the form of a linear sequence of the nucleotides that are linked together as long polymers to form DNA or its cousin RNA. The sequence along the gene specifies the sequence of amino acids that will be linked together to form the protein molecules that are the building blocks and machinery of cells. The identification of the nucleotide sequences of genes and the amino acid sequences of their encoded proteins is proceeding at an extraordinarily rapid pace. This has been sharply accelerated by the human and other genome projects.
The application of biotechnology follows two stages. The first is the isolation of DNA from the cells of an organism, and the determination of the nucleotide sequence of particular regions of that DNA that represent genes. US and European patent offices have been granting patents on such sequences since the Chakrabarty decision (described below). The second stage is the introduction of these genes into cells of different species, or the modification of the genes and reintroduction back into the original species. In these cases, the living organisms have been genetically modified, providing one of the legal arguments for patentability novelty. If the germ cells that provide the sperm or eggs for the next generation are modified, then the progeny of the original individual will also carry the modification. These are referred to as transgenic organisms.
For pharmaceutical production technology, the most useful hosts are presently single- cell organisms which can be grown in a vat, such as bacteria or yeast, or cells isolated from higher organisms, but grown outside the body. Such cells reproduce by relatively simple cell division or budding processes. In agribusiness, the hosts for foreign genes are usually crop plants. In biomedical research and pharmaceutical development, transgenic mice, hamsters, goats, pigs and other animals are generated.
The production of human insulin provides a useful example of the early application of biotechnology to the pharmaceutical industry. From 1930 to 1985, to provide enough insulin for the millions of insulin dependent diabetics, the pancreases of steers and hogs in the slaughterhouse were cut out of the carcasses. From hundreds of thousands of pancreases, the islet cells, representing less than 1per cent of the tissue mass, were dissected out and then diced up and the insulin isolated in a multistep process that, nationwide, required thousands of workers.
Through the application of genetic engineering technology (often called recombinant DNA technology), the gene for human insulin has been spliced into bacteria. These cells are grown in 10,000 litre vats and produce 20 per cent of their mass as insulin. One Eli Lilly plant in Indianapolis produces sufficient human insulin for most of the US population of diabetics. Harnessing the intrinsic reproductive capacity of living organisms means there is no scarcity of insulin in the US or in the world. However, prices have not dropped significantly to reflect the new abundance. High prices have been maintained by a variety of barriers giving monopoly- like control of the market; one of these barriers is patents on the gene sequences.
The breeding, selection and manipulation of species of plants and animals dates back to the domestication of plants and animals and to the origin of agriculture. Financial speculation and corporate development of plant varieties were already well developed in the fifteenth century, as evidenced by Dutch investments in novel tulip strains. Though the contributions of breeders were recognised, these improved strains were not considered to be human inventions in the same sense as manufactured devices. Animal and plant species were excluded from the coverage of British and European patent law.
The key modern efforts to profit from direct ownership of plant germplasm, rather than distribution of the product, began in the 1920s with privatisation of seed production and distribution in the grain belt of the US.9 This led to the proliferation and growth of seed companies such as Pioneer Hi-Bred, DeKalb Genetics and Funk Seeds. The best known innovation of this period was the development of hybrid corn. Hybrid corn is often presented as an advance of agricultural science. In fact, since the offspring of hybrid corn are not as productive as the parents, to obtain consistent high yields farmers need to purchase seed yearly from the originating companies. The switch to hybrid varieties displaced traditional varieties and rendered farmers more dependent on seed companies for next year's crop.
Though successful and profitable, the seed companies were not able to keep other firms from developing hybrid strains and the market was divided. To try to gain monopoly control, seed companies and plant breeders joined efforts to obtain patent protection for certain food and ornamental plants in the 1920s. These efforts encountered resistance from farmers and consumers, leading to a compromise in which there was registration and copyright-like protection for ornamental plants and grafted fruit trees the Townsend-Purnell Plant Patent Act of 1930. This legislation did not bring agricultural products under the existing patent laws but extended copyright protection to certain asexually reproduced plant varieties. A second effort occurred in the 1960s, leading to the Plant Variety Protection Act of 1970, which further extended plant breeders' rights but still kept plants outside of conventional patent law. Recent amendments have continued to erode farmers' rights to save and plant seed.
Similar legal changes were instituted in Europe. In 1961, pressure from seed companies led eight European nations to form the International Union for the Protection of Plant Varieties (UPOV). This was an effort to stiffen domestic plant variety protection laws among the signatory nations, on behalf of Europe's professional breeders. One particularly insidious aspect of these laws in a number of European states are national registration requirements, which make it illegal to plant seeds of varieties that are not registered, driving the farmer into further dependence on commercial varieties.10 But the protection afforded by the various regulatory regimes to the 'owners' of varieties was less than that accorded to holders of traditional utility patents, and the seed/biotechnology industry continued to press for more comprehensive intellectual property protection for engineered plants.
US patent laws were originally written by Thomas Jefferson. 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.11 Jefferson was clear that patents were a form of monopoly. The new nation had come into existence in part because of the recognition of the noxious aspects of monopoly practices. Jefferson believed the importance of the patent laws lay not in the generalised protection of private property, but in the limited and specific purpose of ensuring that creative and inventive individuals were able to make a living from their work, and thus continue to contribute to society. He wrote that whenever this monopoly was contrary to the public interest, the public interest would take precedence.12
This two hundred-year-old legacy was breached in 1980 with the granting of patent protection for a genetically engineered bacterium by the US Supreme Court in Chakrabarty vs. US Patent and Trademark Office.13 The decision was very close (five to four) and was narrowly constructed with respect to genetically modified microorganisms. But it opened the flood gates, and soon Harvard Medical School scientists applied for, and were granted, a patent on a genetically modified mouse. Since then, US, British and European patent offices have issued thousands of patents on genes, plants, animals and even human cell lines. In the US, this process was carried on outside of public perception through the procedures of the Patent and Trademark Office. The transformation has never been addressed by the US Congress. Opposition has been much more developed in Europe, South-east Asia and South America (see below).
The ability to modify organisms' genes, together with legal changes that extend patent protection to such modified organisms, has opened up the possibility of the ownership of entire species---not merely the individuals but all their progeny. Drug companies own patents on human cell lines and on thousands of human genes. Genentech owns patents on a variety of important human growth factors; Sequana Therapeutics has filed for patents on the cells and genes of indigenous tribes in New Guinea. Eli Lilly company owns the patent on the human insulin gene. They have the legal right to prevent other institutions (including non-profit organisations) from using the information in these genes for producing the corresponding proteins. Thus, though the technology for isolating the human insulin gene from human cells (skin, blood etc.) is widely distributed, anyone trying to produce insulin would be subject to infringement suits. Hundreds of millions of dollars worth of such suits are brought regularly within the biotechnology industry as companies jockey for control of the patents.14 Perusal of issues of Biotechnology or other trade journals reveals the aggressive nature of the industry in protecting its intellectual property patents.
Policing intellectual property infringement at the international level is costly and difficult; some companies have been looking for biological means as well to protect their 'inventions', and appropriate more of the agricultural surplus. United States Department of Agriculture (USDA) scientists, working with Delta and Pine Land, the world's largest cotton seed company (now owned by Monsanto) have developed genetically modified crops whose seed can be eaten, but cannot be propagated. The Rural Advancement Foundation International (RAFI) is calling this gene package 'the terminator'. 16
The lead scientist, in quite patriotic fashion, claims that his main reason for working on the 'terminator' project is to protect American inventions abroad. Says primary inventor Melvin Oliver, of the USDA:
My main interest is the protection of American technology...The need was there to come up with a system that allowed you to self-police your technology, other than trying to put on laws and legal barriers to farmers saving seed, and to try and stop foreign interests [read foreign farmers saving seed] from stealing the technology.The targets of this technology are none other than the farmers of the developing world. According to Willard Phelps, spokesman for the USDA, the goal is 'to increase the value of proprietary seed owned by US seed companies and to open up new markets in Second and Third World countries'.17
During the Uruguay Round of GATT, US negotiators put a proposal on the table for the expansion of GATT's scope to include, inter alia, intellectual property rights (IPR). These had formerly been dealt with at the international level within the United Nationıs World Intellectual Property Organisation. But the United States has always had much greater international influence in the less democratic international institutions, such as the UN Security Council, the Bretton Woods institutions (the World Bank and the International Monetary Fund) and GATT. And, by bringing intellectual property into GATT (which has been turned into a formal institution, the World Trade Organisation), and thereby linking the previously distinct areas of trade and intellectual property protection, the US could legitimise its practice of imposing economic sanctions on countries whose intellectual property regimes do not 'effectively' protect the intellectual property of US firms.
Intellectual property rights over life forms have been inserted into GATT in the side agreement on Trade-Related Aspects of Intellectual Property Rights, or the TRIPs agreement. This requires countries to develop national legislation establishing the patentability of micro- organisms, but not plants or animals. Plants must be covered by some type of intellectual property protection, though not necessarily utility patents (as in the United States) which afford the greatest amount of monopoly protection to the companies that hold the patents. However, US negotiators, responding to agribusiness pressure, will seek utility patent protection for plants during the forthcoming 1999 review of the TRIPs agreement.
Until recently, in Brazil, India, Canada and other countries, production of pharmaceuticals and medicinals has been protected from interference by patent monopolies. New power acquired through the TRIPs agreement has made it possible for the US to pressure these countries for domestic changes. While there are clearly reasons why nations would want to protect sectors so important to public health from the pharmaceutical monopolies, US trade officials use the TRIPs agreement to intrude on these domestic decisions. Ironically, the forcing open of domestic policies to international dictates closes off the sectors to monopoly arrangements.
The recent introduction of boll weevil-resistant cotton Bollgardı provides another example. Monsanto played on farmer's fears of boll weevil infection. Some 2.5 million acres were planted with this genetically engineered patented cotton variety in 1996.20 Ironically, a major boll weevil outbreak occurred in 1997, and the 'resistant' cotton proved relatively susceptible, setting back Monsanto's strategy. However, it is likely that this setback is only temporary. Krimsky and Wrubel identify some twenty agrotechnology firms engaged in the development of herbicide resistant crops. Patents will be granted on many of these genetically engineered varieties.
Given the penetration of the market by patented strains, it is not difficult to imagine circumstances where dependence develops, allowing sharp increases in the price of the patented varieties.
The patents make the seed companies more significant investments. Through the buy- out of an arm of W.R. Grace, Agracetus, Monsanto has patents on all soybeans (except in the United States) and all cotton that will be genetically engineered during the next decade and a half. By owning the largest seed companies, biotechnology firms like Monsanto will, in the near future, have an enormous amount of control over what crop varieties will be sold all over the world. By holding the patents on the crop seeds being sold, the firms will have control over how much farmers will pay for those seeds, and how often they will have to buy seeds.
These same companies also tend to be involved in pharmaceuticals as well. The merger of American Home Products and Monsanto created the largest agrochemical firm in the world, as well as the world's fourth largest pharmaceutical firm.
The international laws that facilitate capital's control over the seed may also lead to the appropriation of the culture of farming communities. Basmati rice and jasmine rice are integral to the culture and agriculture (including export agriculture) of India and Thailand, respectively. Recall the patent granted to Rice-Tec, Inc (US patent #5,663,484) on basmati rice that is grown anywhere in the western hemisphere. Not only has the genetic information been claimed, but also the name and the cultural significance. Not long after the patent was granted, a trademark was granted for the name 'jasmati', to be used on a type of jasmine rice.24
The knowledge and culture, and here the two are inseparable, that have developed these varieties of rice have been stolen. In the jargon of the biotechnology industry, this knowledge has been acquired through 'bioprospecting'. Peasants and non-governmental organisations have another word for this acquisition, which they see as illegal. They call it 'biopiracy'.25
An additional but less visible effect following from the patenting of genes and cell lines is the distortion in the priorities of biomedical research and the health care system.27 Profitability depends on selling a product that is protected by intellectual property laws. However, in many cases the key public health step is to identify the aetiology of the disease and prevent it; for example, by identifying carcinogens and removing them from the ecosystem. But this is not compatible with securing super-profits by selling people with cancer a palliative or therapeutic drug. Thus, Myriad Pharmaceutical could use its breast cancer gene technology to identify environmental or occupational carcinogens that cause the damage found in the genes of individuals with breast cancer. Instead, it is using its technology and patent rights to sell a diagnostic test which informs the individual how much damage has already occurred in their genome. Exploiting patents requires selling consumers a product, not keeping them from contracting disease.
The profitability of the insulin market is dependent on millions of people being affected by the disease. Despite the very large biomedical research community focused on diabetes, research on what causes the damage to the insulin-producing or sensing cells is limited. Yet there are a flood of studies on managing the patient in terms of diet factors, genetics and behaviour. These distortions represent insidious long term economic influences on the medical community, rather than the limitations of biomedical science.
Contrary to the claims of patent lawyers, patenting retards progress in biomedical research, introducing secrecy where openness is essential, and slows the publication and sharing of important results. Once a result is reported publicly, it cannot be patented.28 Thus researchers drawn into the web of the patent process do not report their results, even informally, until they have successfully passed through the slow, expensive patent application and granting process. Some of these barriers have recently been explored by Heller and Eisenberg.29
Corporations claim that, without patent protection, important technologies will not be developed. In fact, what patent protection ensures is not technological development, but super- profits. Patents are as often used to prevent the development of new technologies as to exploit them. The role of patents as a mechanism of monopoly pricing rather than technology development has been described in a number of sectors of industry, including antibiotics.
Corporate interests argue that venture capital is harder to raise in the absence of patent protection. In those cases where a therapeutic development is not going forward because of problems in raising capital, though, the capital can be raised through public agencies. For example, vaccines for humans have often been avoided by the pharmaceutical industry, since a few doses provide protection for a lifetime, and liability issues can be serious. In contrast, many firms produce agricultural vaccines for cattle, sheep and pigs since these are slaughtered each year, and new populations are grown up requiring vaccination in turn a much more profitable market. In these cases, the public sector is fully capable of filling the gap. The US Center for Disease Control oversees the production of a number of vaccines, and the National Institute of Health brought the anti-tumour agent, taxol, into production as an experimental drug before the pharmaceutical industry recognised its market potential. Resisting corporate ownership of life forms
In Europe, South-east Asia and South America, there are significant social movements opposing life 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.30 Peasant farmers are struggling to maintain control over the material basis of their livelihood, the agricultural crop plants on which they depend. They are also struggling to maintain control over their culture, as represented in the knowledge of producing and using rice.
It is from these farming communities of the world, in particular in the developing world, that much of the resistance is emanating. At the Second Ministerial Conference of the World Trade Organisation in Geneva, peasants from a global movement called Via Campesina were in attendance. Their press release, issued at the Ministerial Conference, stated: The Via Campesina is demanding ... governments and ... international institutions ... prohibit biopiracy and patents on life (animal, plants, parts of human body) including the development of sterile varieties through genetic engineering.
Some of the strongest resistance to life patents has come from indigenous peoples. Because of their potential genetic uniqueness, they have been the brunt of much poking and swabbing, for blood and cells. And the cells of a number of indigenous individuals have been patented by the United States Department of Commerce. The 'Declaration of Indigenous Peoples of the Western Hemisphere Regarding the Human Genome Diversity Project' has a worldview clearly different from that of the officials in the US Patent and Trademark Office: We oppose the patenting of all natural genetic materials. We hold that life cannot be bought, owned, sold, discovered or patented, even in its smallest form... We denounce and identify the instruments of intellectual property rights patent law ... as tools of legalized western deception and theft. We denounce all instruments of economic apparatus such as NAFTA, GATT and the World Trade Organization (WTO) which continue to exploit people and natural resources to profit powerful corporations assisted by governments and military forces of developed countries.
The European Parliament, responding to the initiatives of the Greens, refused to accept patents on genes. The first vote on such legislation a few years ago ended in a decision against patents on life. Only the full mobilisation of pharmaceutical and biotechnology forces in 1997 led to the defeat of this effort.
As noted above, in 1999 there will be a review of the TRIPs agreement within the WTO, specifically to revisit the provisions that exempt plants from utility patent protection. Developed countries, led by the United States, will attempt to insert a form of words requiring member states to grant utility patents on plants. There will be a significant amount of resistance to this attempt, at both the governmental and non-governmental levels.
In the United States and Canada both religious and secular coalitions have taken clear positions in opposition to life patents. The Blue Mountain Declaration of June 1995 speaks for many:
The humans, animals, microorganisms and plants comprising life on earth are part of the natural world into which we were all born. The conversion of these life forms, their molecules or parts into corporate property through patent monopolies is counter to the interests of the peoples 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. Indigenous peoples, their knowledge and resources are the primary target for the commodification of genetic resources. We call upon all individuals and organisations to recognise these peoples' sovereign rights to self-determination and territorial rights, and to support their efforts to protect themselves, their lands and genetic resources from commodification and manipulation. Life patents are not necessary for the conduct of science and technology, and may in fact retard or limit any benefits which could result from new information, treatments or products ... As part of a world movement to protect our common living heritage, we call upon the world and the congress of the United States to enact legislation to exclude living organisms and their component parts from the patent system. We encourage all peoples to oppose this attack on the value of life.31
The remedy is straightforward. The very recent extension of patent protection to organisms, genes and cells needs to be stopped and reversed. The parliamentary battles that have occurred in India and Europe, and in Switzerland, Germany and Austria need to be expanded to other nations. Since the agri-biotechnology and pharmaceutical industries are using the US government as a major lever in world affairs, it is particularly important that this effort develop in the US and its biotechnology allies: Canada, the UK, France and Germany. The appropriate action is for parliaments to clarify the law with further legislation that excludes living organisms and their parts from patent protection. The development of such issues in the US Congress will probably depend on the emergence in the US of political parties independent of the existing two parties.
The animals and plants that have evolved on the Earth---like the oceans and the atmosphere---are the common heritage of all. Similarly, the genes that are the blueprints and instructions in our cells are shared by all human beings, since we are members of one species, homo sapiens. Allowing corporations to patent---to gain monopoly ownership of organisms and their components---means that life forms are being converted into corporate property. This constitutes a vast new form of privatisation on a global scale. The struggle to maintain species as part of the common heritage of human society, allowing equitable utilisation of their bounty, will be an increasingly important social and economic struggle as we enter the twenty-first century.