The Biotech Century:
Human Life as Intellectual Property
By JEREMY RIFKIN
In little more than a generation, our definition of life and the meaning of existence is likely to be radically altered. Long-held assumptions about nature, including our own human nature, are likely to be rethought. Many age-old practices regarding sexuality, reproduction, birth and parenthood could be partially abandoned. Ideas about equality and democracy are also likely to be redefined, as well as our vision of what is meant by terms such as "free will" and "progress." Our very sense of self and society will likely change during what I call the emerging Biotech Century, as it did when the early Renaissance spirit swept over medieval Europe more than 600 years ago.
Although Dolly the sheep and talk of cloning have gathered sensational headlines and captured the public imagination, many forces are quietly converging to create this powerful new social current. At the epicenter is a technology revolution unmatched in all of history in its power to remake ourselves, our institutions and our world: Scientists are beginning to reorganize life at the genetic level. The new biotechnologies are already reshaping a wide range of fields, including forestry, agriculture, animal husbandry, mining, energy, bioremediation, packaging and construction materials, pharmaceuticals, medicine, and food and drink. Before our eyes lies an uncharted new landscape whose contours are being shaped in thousands of biotechnology laboratories around the world.
Global life-science companies like Novartis, Glaxo Wellcome, SmithKline Beecham, Du Pont, Eli Lilly, Rohm and Haas, Upjohn, Merck and Dow Chemical, in turn, are quickly maneuvering to exert their influence and control over the new genetic commerce. Typical of the trend is the bold decision by the Monsanto Corporation, long a world leader in chemical products, to sell off its entire chemical division in 1997 and anchor its research, development and marketing in biotech-based technologies and products. The consolidation of the life-science industry by global commercial enterprises rivals the consolidations, mergers and acquisitions going on in the other great technology arenas of the twenty-first century--computer telecommunications, entertainment and information services--although much less attention has been focused on it in the media and public policy.
Great economic changes in history occur when a number of technological and social forces come together to create a new "operating matrix." I see seven strands composing the operating matrix of the Biotech Century. Together, they create a framework for a new economic era:
§ First, the ability to isolate, identify and recombine genes is making the gene pool available, for the first time, as the primary raw resource for future economic activity. Recombinant DNA techniques and other biotechnologies allow scientists and biotech companies to locate, manipulate and exploit genetic resources for specific economic ends.
§ Second, the awarding of patents on genes, cell lines, genetically engineered tissue, organs and organisms, as well as the processes used to alter them, is giving the marketplace the commercial incentive to exploit the new resources.
§ Third, the globalization of commerce and trade make possible the wholesale reseeding of the Earth's biosphere with a laboratory-conceived Second Genesis, an artificially produced bioindustrial nature designed to replace nature's own evolutionary scheme. A global life-science industry is already beginning to wield unprecedented power over the vast biological resources of the planet. Life-science fields ranging from agriculture to medicine are being consolidated under the umbrella of giant "life" companies in the emerging biotech marketplace.
§ Fourth, the mapping of the approximately 100,000 genes that make up the human genome and new breakthroughs in genetic screening, including DNA chips, somatic gene therapy and the imminent prospect of genetic engineering of human eggs, sperm and embryonic cells, are paving the way for the wholesale alteration of the human species and the birth of a commercially driven eugenics civilization.
§ Fifth, a spate of new scientific studies on the genetic basis of human behavior and the new sociobiology that favors nature over nurture are providing a cultural context for the widespread acceptance of new biotechnologies.
§ Sixth, the computer is providing the communications and organizational medium to manage the genetic information that makes up the biotech economy. All over the world, researchers are using computers to decipher, download, catalogue and organize genetic information, creating a new store of genetic capital for use in the bioindustrial age. Computational technologies and genetic technologies are fusing into a powerful new technological reality. Microsoft chairman Bill Gates sums up the new collaborative efforts by saying, "This is the information age, and biological information is probably the most interesting information we are deciphering and trying to decide to change. It's all a question of how, not if."
§ Seventh, a new cosmological narrative about evolution is beginning to challenge the neo-Darwinian citadel with a view of nature compatible with the operating assumptions of the new technologies and the new global economy. The new ideas about nature provide the legitimizing framework for the Biotech Century by suggesting that the way we are reorganizing our economy and society are amplifications of nature's own principles and, therefore, justifiable.
In short, the Biotech Century brings with it a new resource base, a new set of transforming technologies, new forms of commercial protection, a global trading market to reseed the earth with an artificial Second Genesis, an emerging eugenics science, a new supporting sociology, a new communications tool to organize and manage economic activity at the genetic level and a new cosmological narrative. Together, genes, biotechnologies, life patents, the global life-science industry, human gene screening and surgery, the new cultural currents, computers and revised theories of evolution are beginning to remake the world.
Human Life as Intellectual Property
Genes are the "green gold" of the Biotech Century. The economic and political forces that control the genetic resources of the planet will exercise tremendous power over the future world economy, just as the industrial age access to and control over fossil fuels and valuable metals helped determine control over world markets. Multinational corporations are already scouting the continents, hoping to locate microbes, plants, animals and humans with rare genetic traits that might have future market potential. After locating the desired traits, biotech companies are modifying them and then seeking patent protection for their new "inventions."
Corporate efforts to enclose and commodify the gene pool are meeting with strong resistance from nongovernmental organizations and countries in the Southern Hemisphere, which are beginning to demand an equitable sharing of the fruits of the biotech revolution. While the technological expertise needed to manipulate the new green gold resides in scientific laboratories and corporate boardrooms in the North, most of the genetic resources that are essential to fuel the new revolution lie in the tropical ecosystems of the South. Transnational companies argue that patent protection is essential if they are to risk financial resources and years of research and development bringing new and useful products to market. Southern countries, however, argue that the real research and development effort takes place years before the scientists ever set eyes on the organism and gene, by villagers and peasant farmers who isolate, enhance and preserve valuable herbs and plant crops. That being the case, they claim some form of compensation for their contribution to the biotech revolution.
A growing number of nongovernmental organizations, as well as some countries, are beginning to take a third position, arguing that the gene pool ought not to be for sale at any price--that it should remain an open commons and continue to be used freely by present and future generations. They cite precedent in the recent historic decision by the nations of the world to maintain the continent of Antarctica as a global commons free of commercial exploitation.
The debate over life patents has taken on even greater urgency of late with increasing reports of scientific institutions as well as pharmaceutical and biotech companies bioprospecting the human genome itself in remote regions of the world. The Human Genome Diversity Project, a scientific effort headed by Dr. Luigi Luca Cavalli-Sforza, a population geneticist and professor emeritus at Stanford University, has been the subject of increasing controversy since it became public that the group planned to take blood samples from the world's 5,000 linguistically distinct populations in order to assess their genetic makeup and search for any unique genetic traits they may have that might prove important and useful in the future.
Project sponsors hope that by sampling the genomes of the few groups of indigenous peoples that have remained isolated from the rest of the outside world, they will find some "genetic surprises" that could be a boon to humankind in its search for new ways to improve the genetic makeup of the race. Cavalli-Sforza defends the research, dubbed the "vampire project" by its critics, saying it is important to seek out whatever remaining genetic variety exists before it's irretrievably lost, either as a result of the extinction of these populations or through their melding into the general population. Cavalli-Sforza says that while his personal view is that there should be no patents on DNA, he felt that the commercial value of the genetic information emerging from the Human Genome Diversity Project may make such notions impractical. He suggests, therefore, that "in the unlikely event that there is some gene that becomes commercially valuable, the people who donated it--not the individual, but the group--should somehow share in the advantages."
The concerns of critics came alive in 1993, when the Rural Advancement Foundation International, a nongovernmental organization, discovered that the U.S. government had sought both U.S. and international patents on a virus derived from the cell line of a 26-year-old Guaymi Indian woman from Panama. A researcher from the National Institutes of Health had taken a blood sample from the woman and developed the cell line. The Guaymi cell line was of particular interest to N.I.H. researchers because members of this remote Indian community carry a unique virus that stimulates the production of antibodies that scientists believe might be useful in AIDS and leukemia research.
Upon learning about the patent application, representatives of the Guaymi General Congress in Panama waged a public protest. Isidro Acosta, president of the congress, said at the time that he was shocked that an august scientific body like the N.I.H. could so wantonly violate the genetic privacy of his tribe and that the U.S. government, without advising the Guaymi of its intentions, could then seek to patent a genetic trait of the Guaymi and profit from their biological inheritance in the global marketplace:
I never imagined people would patent plants and animals. It's fundamentally immoral, contrary to the Guaymi view of nature, and our place in it. To patent human material...to take human DNA and patent its products...that violates the integrity of life itself, and our deepest sense of morality.
The public protest forced the U.S. government to withdraw its patent application. The controversy over patenting genes from indigenous peoples flared again, however, several months later when the U.S. government filed two additional patent claims in the United States and Europe for cell lines taken from citizens of the Solomon Islands and Papua New Guinea. When the government of the Solomon Islands issued a protest, thenSecretary of Commerce Ron Brown responded curtly:
Under our laws, as well as those of many other countries, subject matter relating to human cells is patentable and there is no provision for considerations relating to the sources of the cells that may be the subject of a patent application.
In March 1995, the U.S. Patent Office issued a patent for the Papua New Guinea Human T-lymphotrophic virus (HTLV-i) to the Department of Health and Human Services, making it the first human cell line from an indigenous population to be patented. Angry at the U.S. action, a group of South Pacific island nations prepared a joint proposal and communiqué that would make their sovereign space a "patent-free zone." The United States quietly dropped the patent claim in 1996.
The Indian government has also expressed its deep misgivings about research efforts to secure blood samples. India, with its diverse cultures and inbred populations, is considered to be an ideal setting for gene prospecting. "Name any genetic disorder and we have the mutations," says Samir Brahmachari, professor of molecular biophysics at the Indian Institute of Science in Bangalore. For example, in West Bengal, where cholera is an ever-present threat, a large group of people appear to be immune to the disease. Scientists are now searching for the gene or genes that might confer the genetic advantage in hopes of finding a new form of treatment for the disease.
In January 1996 the Indian Society of Human Genetics issued a set of guidelines calling for a ban on the transport of "whole blood, cell-lines, DNA, skeletal and fossil material" pending formal agreements between collaborating parties. The I.S.H.G. made it clear that any such agreement should specify "the objectives of the project and the anticipated scientific material and economic benefits and the manner that they are to be shared both at present and in the future." The action came in the wake of revelations that the U.S. National Institutes of Health was illegally securing DNA and blood samples from patients at private eye hospitals in India without obtaining the appropriate authorization required to take samples out of the country. Researchers from the N.I.H.'s National Eye Institute were searching for genes that cause retinitis pigmentosa, or night blindness. The Indian Council of Medical Research said it should have been notified of the research in advance, as Indian law forbids the export of biological material without permission from the I.S.H.G.
It seems there is no place on earth too remote for the gene hunters to go. In April 1997 the Los Angeles Times reported on a scientific expedition led by Dr. Noe Zamel, a University of Toronto medical geneticist, and financed by Sequana Therapeutics of La Jolla, California. Sequana is one of a handful of new biotech start-up companies dedicated to gene prospecting. The "genomics" firms are on the commercial frontier of the emerging biotech revolution.
The Sequana team traveled, by way of a South African Navy ship, to the tiny volcanic island of Tristan da Cunha, a strip of forty square miles in the middle of the Atlantic Ocean often referred to as the world's loneliest island. Its few hundred residents are the descendants of British sailors who arrived in 1817. What makes this small inbred local population interesting to Zamel and his team is that half of them suffer from asthma. Scientists hope to find the gene or genes responsible and patent them.
Company scientists took blood samples from 270 of the island's 300 residents and later reported that it had located two "candidate genes" responsible for asthma. However, thus far the company has refused to share its findings with other researchers in the field, giving rise to charges that it is putting commercial considerations above collaborative efforts to find a cure for the disease. For their part, genomics companies like Sequana acknowledge that they're in business to exploit the human genome commercially and could not hope to turn a profit if they couldn't keep their research proprietary--at least until it's patented. Sequana and other genomics firms maintain that market incentives are the best and most efficient way to advance the research. Others aren't so sure. "The issue is a nightmare," said one geneticist working for a large pharmaceutical company, who spoke off the record to Nature magazine's editor.
Foreign nationals aren't the only ones whose cell lines and genomes are being patented by commercial companies in the United States. In a precedent-setting case in California, an Alaska businessman named John Moore found his own body parts had been patented, without his knowledge, by U.C.L.A. and licensed to the Sandoz Pharmaceutical Corporation. Moore had been diagnosed as having a rare cancer and underwent treatment at U.C.L.A. An attending physician and university researcher discovered that Moore's spleen tissue produced a blood protein that facilitates the growth of white blood cells that are valuable anti-cancer agents. The university created a cell line from Moore's spleen tissue and obtained a patent on its "invention" in 1984. The cell line is estimated to be worth more than $3 billion. Moore subsequently sued the University of California, claiming a property right over his own tissue. In 1990 the California Supreme Court ruled against Moore, holding that he had no property right over his own body tissues. Human body parts, the court argued, could not be bartered as a commodity in the marketplace. However, the court did say that the "inventors" had a responsibility to inform Moore of the commercial potential of his tissue and, for that reason alone, had breached their fiduciary responsibility and might be liable for some kind of monetary damage. Still, the court upheld the primary claim of the university that the cell line itself, while not the property of Moore, could justifiably be claimed as the property of U.C.L.A. The irony of the decision was captured by Judge Allen Broussard in his dissenting opinion. He wrote that
the majority's rejection of plaintiff's conversion cause of action does not mean that body parts may not be bought and sold for research or commercial purpose or that no private individual or entity may benefit economically from the fortuitous value of plaintiff's diseased cells. Far from elevating these biological materials above the marketplace, the majority's holding simply bars plaintiff, the source of the cells, from obtaining the benefit of the cell's value, but permits defendants, who allegedly obtained the cells from plaintiff by improper means, to retain and exploit the full economic value of their ill-gotten gains free of...liability.
The extraordinary implications of privatizing the human body--parceling it out in the form of intellectual property to commercial institutions--are illustrated quite poignantly in the case of a patent awarded by the European Patent Office to a U.S. company named Biocyte. The patent gives the firm ownership of all human blood cells that have come from the umbilical cord of a newborn child and are being used for any therapeutic purposes. The patent is so broad that it allows this one company to refuse the use of any blood cells from the umbilical cord to any individual or institution unwilling to pay the patent fee. Blood cells from the umbilical cord are particularly important for marrow transplants, making it a very valuable commercial asset. It should be emphasized that this patent was awarded simply because Biocyte was able to isolate the blood cells and deep-freeze them. The company made no change in the blood itself. Still, the company now possesses commercial control over this part of the human body.
A similarly broad patent was awarded to a U.S. firm, Systemix, of Palo Alto, California, by the U.S. Patent Office, covering all human bone-marrow stem cells. This patent on a human body part was awarded despite the fact that Systemix had done nothing whatsoever to alter or engineer the cells. Some, even in the medical establishment, were stunned by the Patent Office's decision. Dr. Peter Quesenberry, the medical affairs vice chairman of the Leukemia Society of America, quipped, "Where do you draw the line? Can you patent a hand?"
On the other hand, many in the molecular biology field see no apparent ethical problem or moral dilemma in gene prospecting and are laying claims to vast regions of the human genome. Arnold Slutsky of the Samuel Lunenfield Institute of the Mount Sinai Hospital of Toronto asks rhetorically, "If a journalist writes an article on a family, and then wins a Pulitzer Prize, does he give the family a percentage of his winnings?"
The entrepreneurial scramble to patent the genome of the human family has picked up substantial momentum over the past several years, in large part because of the quickened pace of mapping and sequencing the approximately 100,000 genes that make up the human genome. As soon as a gene is tagged, its "discoverer" is likely to apply for a patent, often before even knowing the function or role of the gene. In 1991 J. Craig Venter, then head of the N.I.H. Genome Mapping Research Team, resigned his government post to head up a genomics company funded by a venture capital fund for more than $70 million. At the same time, Venter and his colleagues filed applications seeking patents on more than 2,000 human brain genes. Many researchers working on the Human Genome Project were shocked and angry, charging Venter with attempting to profit from research initially paid for by U.S. taxpayers. A number of scientists were upset because Venter sought patents on genes before even knowing their function. Nobel laureate Dr. James Watson, co-discoverer of the DNA double helix and the former head of the Human Genome Project, called the Venter patent claims "sheer lunacy." Still, it's likely that within less than ten years, the nearly 100,000 or so genes that constitute the genetic legacy of our species will be patented, making them the exclusive property of global pharmaceutical, chemical, agribusiness and biotech companies.
The increasing consolidation of corporate control over the genetic blueprints of life as well as the technologies to exploit them is alarming, especially when we stop to consider that the biotech revolution will affect every aspect of our lives. The way we eat; the way we date and marry; the way we have our babies; the way our children are raised and educated; the way we work; the way we engage in politics; the way we express our faith; the way we perceive the world around us and our place in it--all our individual and shared realities will be deeply touched by the new technologies of the Biotech Century.
The debate over life patents is one of the most important issues ever to face the human family. Life patents strike at the core of our beliefs about the very nature of life and whether it is to be conceived of as having intrinsic, or mere utility, value. The last great debate of this kind occurred in the nineteenth century, over the issue of human slavery, with abolitionists arguing that every human being has intrinsic value and "God-given rights" and cannot be made the personal commercial property of another human being. The abolitionists' argument ultimately prevailed, and legally sanctioned slavery was abolished in every country in the world where it was still being practiced.
Like the anti-slavery abolitionists of the nineteenth century, a new generation of genetic activists is beginning to challenge the very concept of patenting life, arguing that life is imbued with intrinsic value and therefore can never be legitimately reduced to commercial intellectual property controlled by global life-science conglomerates and traded as mere utilities in the marketplace. Feminists, farmers, animal rights groups, consumer organizations, health advocates and social justice organizations around the world are coalescing into a new and powerful countervailing force to the growing genetic commerce that trades in the blueprints of life.
In May 1995 a coalition of more than 200 religious leaders, including the titular heads of virtually every major Protestant denomination, more than a hundred Catholic bishops and Jewish, Muslim, Buddhist and Hindu leaders, announced their opposition to the granting of patents on animal and human genes, organs, tissues and organisms. The effort was organized by the Foundation on Economic Trends, which I head.
The coalition, the largest assemblage of U.S. religious leaders to come together on an issue of mutual interest in the twentieth century, said that the patenting of life marked the most serious challenge to the notion of God's creation in history. How can life be defined as an invention to be profited from by scientists and corporations when it is freely given as a gift of God, ask the theologians? Either life is God's creation or a human invention, but it can't be both. Speaking for the coalition, Jaydee Hanson, an executive with the United Methodist Church, said, "We believe that humans and animals are creations of God, not humans, and as such should not be patented as inventions." While not all the religious leaders oppose "process" patents for the techniques used to create transgenic life forms, they are unanimous in their opposition to the patenting of the life forms and the parts themselves. They are keenly aware of the profound consequences of shifting authorship from God to scientists and transnational companies and are determined to hold the line against any attempt by "man" to stake his own claim as the prime mover and sovereign architect of life on earth.
What might it mean for subsequent generations to grow up in a world where they come to think of all life as mere invention--where the boundaries between the sacred and the profane, and between intrinsic and utility value, have all but disappeared, reducing life itself to an objectified status, devoid of any unique or essential quality that might differentiate it from the strictly mechanical? The battle to keep the earth's gene pool an open commons, free of commercial exploitation, is going to become one of the critical struggles of the Biotech Age. "Genetic rights," in turn, is likely to emerge as the seminal issue of the coming era, defining much of the political agenda of the Biotech Century.
This article is adapted from Jeremy Rifkin's new book, The Biotech Century: Harnessing the Gene and Remaking the World (Tarcher/Putnam). Rifkin is president of the Foundation on Economic Trends in Washington, D.C.