Introduction

Subsections:

How biotechnology industries present themselves

Reality of the past few years

Modern biotechnology--or "biological engineering," as Vandana Shiva (1993) has more exactly named it--has seized the imaginations and elicited the concerns of virtually every sector of society. Opinions about the nature, utility and value of biotechnology vary, and disagreements abound. Business executives extol its seemingly miraculous capacity to solve the chronic problems of hunger and disease. Public interest groups worry about the long-term effects of its application to human and nonhuman environments and communities. Nonspecialists show a mixture of skepticism and curiosity about the motives of both research into biotechnology and its attendant industries. The attitude of scientists and engineers ranges from enthusiasm to profound disquiet, depending mainly on who pays for their studies and whether they are engaged in "applied" or "general" research.

The history of biotechnology's institutional approbation and stricture is complex and convoluted. It was scientists working in the 1970s with newly discovered techniques of biotechnology who first made public the potential dangers of the products that might result from their experiments. Nevertheless, the advance of biotechnology was not checked. By the end of the decade the United States Supreme Court had decided that life forms could be subject to patents. It thereby set a precedent that gave industries protective sanction and powerful inducement in promulgating biological engineering (Kimbrell 1993). Massive investment in research and development (R&D) caused the biotechnology industry in agriculture, medicine and biochemicals to burgeon. The growth of these industries survived even the US stock market crash of 1987 (OTA 1991).

Significantly, the peak in investment and market activity in biotechnology in 1991 coincided with the preparations for the United Nations Conference on Environment and Development (UNCED), the purview of which included the completion of Agenda 21, a non-binding agenda for conservation and sustainable development in the coming century, and the opening for signature of the legally binding Convention on Biological Diversity (CBD), which provides for access to genetic resources, technology transfer and the handling of biotechnology and the distribution of its presumed benefits (ISCBD 1994). When US President George Bush refused to sign the latter, it was due to pressure from biotechnology industries, which were concerned with how their research and commerce might be affected negatively by the treatment of intellectual property rights under the CBD (Downes 1993; Shiva 1993). President Clinton signed the CBD in 1993 after he had assured biotechnological companies and industry associations in a written "interpretive statement" that his administration would protect intellectual properties according to the standards of the agreement on trade-related aspects of intellectual property (TRIPs) of the Uruguay Round of the General Agreement on Trade and Tariffs (GATT), and that it would not consent to a legally binding protocol to the Convention regulating the handling, transfer and use of biotechnological products (Lane and Schweiger 1995).

Tensions, contradictions and double standards between demand for the protection of intellectual property and that of regulation, as they are relevant to the nature of biotechnology and its impact on the environment and human society, obtain throughout the tortuous history of modern biotechnology. They are the subject of this paper. In particular, publicly, biotechnology industries demand intellectual property protection on grounds that their products and processes are "novel" or even "revolutionary". However, they insist in public just as strongly that the same are no more than "extensions of traditional methods" when confronted with the possibility of health and environmental regulation. Whether this double standard is an issue of confusion or dissemblance remains to be seen. The problem before us is to determine whether and how modern biotechnology is novel, and to tease out the actual, sometimes hidden, links between biotechnology, intellectual property rights and regulation. Therefore, this paper has a number of related purposes:

1. to analyze some of the conflicting concepts of biotechnology;
2. to dissect the rhetoric that veils the purpose of intellectual property rights and importance of regulation;
3. to argue that the expansion of the scope of intellectual property rights, in particular its extension to living organisms, as well as its function in industrial and international trade, have a detrimental effect on local, decentralized and sustainable economies;
4. to show that--contrary to the protestations of industries--modern biotechnology poses unique ecological and socio-economic threats and requires legally binding international regulation;
5. to suggest that our system of economic and social values must change accordingly, making a few preliminary recommendations for appropriate institutions to solve problems of intellectual property rights and international regulation of biotechnology.

In its broadest sense "biotechnology" refers to the use of living organisms for human purposes (Rissler and Mellon 1993). "Genetic engineering"--direct manipulation of organisms' hereditary material, or "genes"--as modern biotechnology is popularly known, is a recent development. Discoveries in molecular biology and solid state physics in the 1960s and 1970s made the techniques of modern biotechnology possible. The major techniques involve the "recombination" of the genetic material de-oxyribonucleic acid (DNA), commonly called "rDNA" or "gene splicing," and cell-fusion, or "hybridoma" (Anonymous 1989; Fincham and Ravetz 1991; Juma 1989). The former includes techniques of cloning using DNA segments called "plasmids," growing hybridized cell lines, and microscopic injection of genetic material into cells; the latter involves the delicate blending of the matter of two living cells (Fincham and Ravetz). For example, in the early 1970s it was discovered that the Escherichia coli bacterium contained circular plasmids floating free in its liquid cytoplasm. Because of their simple shape and accessibility, these plasmids became one of the vehicles genetic engineers use to transfer genes between organisms (Fincham and Ravetz; Anonymous 1989).

In the meantime certain sectors of society have become alarmed by the potential dangers of new biotechnological techniques and products. These concerns, especially among molecular biologists, caused a committee of the US National Academy of Sciences to call for a moratorium on rDNA experiments until clear and effective guidelines had been laid down (Fincham and Ravetz; Shiva 1993). The ensuing debate culminated in 1975 in the statement of the conference at Asilomar, California. The researchers participating in the Asilomar Conference were concerned primarily with the deliberate development through rDNA techniques of antibiotic-resistant bacteria and carcinogenic, self-replicating DNA elements. They called for a moratorium on such research. They also called for the establishment of guidelines for rDNA research, the use of safe bacteria and safe gene-transmitting vectors (incapable of surviving outside the controlled conditions of the laboratory), as well as an end to experimentation using known carcinogens and genes determining antibiotic resistance or toxin production (Fincham and Ravetz; Shiva; Juma 1989). Such a large group of scientists and engineers has made no call for caution and regulation so broad and well publicized since. Calestous Juma (now Executive Secretary of the CBD) remarks that "[a]t that time biotechnology work was largely in the hands of researchers, and corporate interests had not taken over most of the major research lines" (1989: 129).

The statement of the Asilomar Conference was one of the first expressions of what has come to be known as the "precautionary principle": a stance on the development of new technologies that has been embodied in a number of subsequent international agreements, including Agenda 21 and the CBD. Fincham and Ravetz sum up its relevance to biotechnology at the time: "Concern about the possible consequences of playing recklessly with known pathogens was joined to a general fear of the unknown that was not entirely irrational, since the unknown in question had the potential for unlimited replication [emphasis added]" (1991: 19). Research in the years that have followed has demonstrated that concerns about the ramifications of biotechnology are entirely rational, and that they apply to a broad spectrum of environmental, socio-economic and human health issues.

The industrialization of the new biotechnology continued unabated. In 1980 the US Supreme Court ruled in Diamond v. Chakrabarty that living microorganisms may be protected by utility patents, which are usually reserved for processes, machines and manufactures (Kimbrell 1993; OTA 1991). The claimant, Ananda Chakrabarty, a General Electric Company engineer whose patent application for a bacterium that would digest petroleum was contested, is reported to have exclaimed "I won!" when the Court handed down its decision. As Andrew Kimbrell points out, "Actually the real winners emerged over the next few months on Wall Street as fledgling biotech companies like Genentech and Cetus, now buoyed by the prospect of patent profits, caused buying frenzies on the floor of the stock exchange" (1993: 196)

From 1980 to 1984 funding surged for companies dedicated to biotechnology, during which period approximately sixty percent of these companies were founded (OTA 1991: 45). Biotechnology companies, based mainly in the United States, but also flourishing in Europe and Japan, had their greatest bull market in 1991, when the total public equity raised exceeded $3.6 billion, and the American Exchange Biotechnology Index of fifteen major stocks reached 225 points (Hamilton 1994).

In April 1987 the US Patent and Trademark Office (PTO) issued an order, based on its interpretation of the ruling in Diamond v. Chakrabarty, that extended patent protection to all "multicellular living organisms, including animals," but--ostensibly--excluding humans. The following year the PTO granted the first patent on a living animal. The animal was a mouse genetically engineered to be predisposed to developing various cancers, with which researchers could test carcinogens (Kimbrell 1993). Only thirteen years had passed since the Asilomar Conference issued its admonition against engineering with genetic pathogens and introducing genetic predispositions.

The legal precedent Diamond v. Chakrabarty set has found its most recent and most deeply ramifying expression in the California Supreme Court's ruling in the case of Moore v. the Regents of the University of California. John Moore was an Alaskan businessman who in the mid-1970s was suffering from a rare and virulent form of leukemia and receiving treatment at the medical center of the University of California at Los Angeles (UCLA). Andrew Kimbrell (1993: 205-10) provides one of the best summaries of this case. The attending physician and a UCLA researcher discovered that Moore's dangerously enlarged spleen was producing a blood protein that induces the growth of antibacterial and cancer-fighting blood cells. Having removed Moore's spleen, they developed a cell line from his T-lymphocytes (white blood cells) that produced valuable medicines. Between 1976 and 1983, Moore's physician took samples of his tissues, explaining to Moore that these were needed for Moore's own welfare and never telling him that they were being used to develop valuable cell lines. In 1981 the Regents of the University of California applied for a patent on Moore's cell line, listing Moore's physician and the UCLA researcher as inventors. Shortly thereafter they entered into contracts with several biotechnological companies.

In 1984 Moore sued the all the parties that were listed on the patent application. Although a lower court threw the suit out on a technicality, Moore won in the California Court of Appeals in 1988. The court ruled that Moore's consent to surgery did not imply consent to the commercial exploitation of his tissues. However, the ruling was reversed on appeal to the California Supreme Court in 1990, which decided that Moore had no "property right" to his bodily tissues and that they were freely donated, as they would be by any other organ donor. Kimbrell notes the development of a double standard: "Chakrabarty, as modified by Moore, now means that Moore has no right to ownership of his body, but the University of California does. The organ donor must be governed by altruism, but the patent holder can make billions" (210).

This decision finds an analogy in the relationship between First and Third World countries. Like Moore, Third World countries, generally the richest in biological resources, are supposed to give freely of their resources, which corporations, mainly in the industrialized Northern Hemisphere, then can analyze, claim as intellectual property and convert to profitable chemicals, drugs and genetically engineered substances. We shall return to this issue and that of commodity production as "invention" in the final section of this paper.

How biotechnology industries present themselves

Biotechnology industries and much of the mass media tout modern biotechnology as little less than miraculous. Genetic engineering is said to be responsible for two revolutions in contemporary society: a technological revolution, which promises solutions to the chronic problems of hunger and disease, and a productive revolution, which will increase the efficiency of research, development and manufacture of new products. Fred Davison, former president of the University of Georgia (an institution engaged in biotechnology R&D), heralded the epoch with the statement: "I believe that biotechnology presents to us today opportunities that are so great that we can't conceive what those benefits might be. We can only begin to see some of the indications." He professes the belief that the coming age "can be the most exciting period, in my estimation, in recorded history. I think, personally, it will be" (quoted in Anonymous 1987: 7). Whether any of these superlatives is justified--or whether the opportunities already taken indicate benefits or risks--are matters treated below.

Like most industries, those involving biotechnology present their aims as altruistic. Reflecting on the successes of previous biotechnologies in the field of agriculture, the Industrial Biotechnology Association (now the Biotechnology Industry Organization, BIO) makes this claim: "By the 1950s classical genetics was making enormous contributions in academic research and traditional agriculture, and it was playing a major role in the Green Revolution, which has been responsible for averting starvation in many parts of the developing world" (Anonymous 1987: 1).

The same effect, it insists, is promised by genetic engineering. "Picture," suggests the Association, "a family enjoying food grown a the edge of Africa's Sahara desert" (1). Pilot projects, like Pepsi Foods in India, have been acclaimed as a "catalyst for the next agricultural revolution" and a "programme for peace" (see Shiva 1991: 194-229). This acclaim despite the fact the main elements of this new Green Revolution are the substitution of rice and wheat with fruits and vegetables for foreign markets, and the replacement of old Green Revolution technologies by biotechnologies requiring as much, if not more, chemical input and special processing (Shiva 1991: 198). The old Green Revolution, based on high-yielding varieties (HYVs) of grain, has resulted in environmental destruction and socio-economic disruption (Shiva; see below).

Biotechnology industries are also promoting their message preemptively. Since 1987 the Mathematics and Science Education Center of St Louis, Missouri, has been developing the Biotechnology Education Project in the primary schools. The Project is sponsored and informed by the Monsanto Company (through the Monsanto Fund) and the US National Science Foundation (NSF). A recent brochure advertising the school program advises,

The biotechnology revolution is happening in an age of widespread dissemination of information and concentrated media coverage. Therefore, there is a need to develop an awareness and an understanding of biotechnology and its implications. Learning about the effects of the biotechnology revolution on society is fundamental to grasping the historical significance and the impact of this science on future research.

Other statements from industry are more cautious but no less visionary and seemingly magnanimous. Howard Schneiderman, Senior Vice President of the Monsanto Company, told an audience of microbiologists in 1987,

We do not yet have a reliable vaccine for some diseases like malaria, AIDs or schistosomiasis. But an effective vaccine for starvation is well known to all of us--food. Starvation is an unnecessary disgrace in our global society. In my brief remarks, I should like to offer evidence that biotechnology provides an opportunity to enhance the food production of developing tropical countries in a safe, clean and ecologically sound wayÉ. Biotechnology will not solve the problems of world hunger. I hope to show you that it can be a powerful tool in that struggle, and a good case can be made that it is a necessary tool (1987: 1-2).

Overall, the agricultural biotechnology industry maintains that its aims are to provide farmers with hardier, disease-resistant varieties, to secure a high net yield, and to improve crop reliability, cost effectiveness, crop quality and crop diversity (Anonymous 1987; Anonymous 1992).

In the field of medicine biotechnology promises four major benefits: genetically engineered biochemical drugs, new vaccines, gene therapy and quicker product development. Bacteria are exploited as living factories for proteins, such as enzymes and hormones, that help regulate the function of human (and in some applications animal) bodies (Anonymous 1989; Fincham and Ravetz 1991). Biotechnology has had some outstanding successes in this area, not the least of which is the production of human insulin through E. coli bacteria. Furthermore, strains of bacteria and viruses associated with disease are genetically engineered to produce appropriate anti-bodies, while supposedly not expressing their virulent properties (Fincham and Ravetz).

Gene therapy is promoted as one of biotechnology's greatest gifts to humanity. Gene therapy promises to cure birth defects, such as phenylketonuria, and congenital dispositions to such diseases as Parkinsonism, cystic fibrosis, sickle-cell anemia, as well as various forms of cancer, among diseases that genetic scientists think are caused by "missing or "defective" genes. The idea is that once these defects are identified, biochemicals produced in the laboratory by the appropriate genes can be administered to patients, or the genetic material itself can be introduced into their cells (Carey 1994; Fincham and Ravetz 1991; Newman 1989). A recent front-page article in the Washington Post announced the first "success" of gene therapy: two young girls suffering from a rare immune-system disorder, adenosine deaminase, who have survived five years' of treatment (Weiss 1995). However, the article qualifies the celebration with: "Enthusiasm is somewhat tempered, however, because it remains unclear how much of the girls' improvement can be attributed to their new genes and how much is due to a new drug they also have been taking" (ibid.).

Gene therapy is still largely speculative (Carey 1994), and experts have criticized research on grounds that it is simplistic, in that it does not account for the complex interactions among genes and other biochemicals, and reductionistic, in that it ignores non-genetic factors in disease (Newman 1989). Newman points out that even such patently infectious agents as the influenza virus--which preferentially attacks those genetically susceptible--could be considered "genetic diseases" in epidemic circumstances (1989). Genetic reductionism is fashionable these days among specialists and nonspecialists alike. Prominent scientists promote it with such sweeping statements as "In the deepest sense we are who we are because of our genes" (R.L. Sinsheimer, one of the architects of the Human Genome Project, quoted in Berkowitz 1996). Ari Berkowitz, a neurobiologist at the California Institute of Technology, has this to say about reductionism: The search for a gene for each category of experience and behavior may partly be a result of the culture of modern science. Scientists generally seek to reduce complex phenomena to simple descriptions. Such simplification has proven to be extremely useful in devising experiments that are likely to give clear and informative results.... However, in the desire to extrapolate findings from simple systems to the most sophisticated functions of human beings, it is sometimes forgotten that different or additional principles may apply to the most complex systems (1996: 49). (The problem of reductionism in biotechnology will recur throughout this essay.)

Biotechnology also promises to accelerate product development. In the pharmaceutical industry conventional screening, an essentially random process, has been replaced by a "more mechanistic and physiological approach to drug discovery and design" (OTA 1991: 74). This means that the effects of specific genes, such as the production of a certain hormone, are being studied, in order to reproduce them in the laboratory. Like gene therapy, drug screening is conducted with a very reductionistic attitude toward both the source of the drug and the body to which it is administered.

Biotechnology companies are also always eager to assert that their methods and products are designed with current ecological concerns in mind. A paper published by the Monsanto Company suggests that "biotechnology offers Nature's own method to protect the Global Commons--the air, the rain forest, the oceans" (Schneiderman 1987). A more recent booklet by Monsanto, The New Biology: the Science and its Applications, maintains that "[b]iotechnology can help farmers around the globe promote sustainable agriculture. Steady progress is being made to develop better ways for farmers to protect their crops from diseases and insect pests, improve their yields, grow healthier foods, and protect the environment" (Anonymous 1992: 20). Indeed, the use of the term "new biology" is strategic. "Biology" implies research into (and perhaps application of) something purely natural, as opposed to "biotechnology." Biotechnology industries are wont to suggest that nothing harmful can come of duplicating genotypes already found in nature. However, Sharples (1987) has debunked the fallacy that something must be truly "unique"--i.e., not found in nature--to have the potential for harm, as well its supporting premise that all genotypes have been expressed at some point in evolution, the inviable and dangerous ones having been extinguished. Moreover, Rissler and Mellon (1993), among others, have pointed out that there is no unique correspondence between a gene and its expression; one gene can have an effect on multiple traits ("pleiotropy"), and genes can modify one another's expression ("epistasis").

Reality of the past few years

Despite all the frenzied speculation in and marketing of biotechnology, by 1991 the US Congress's Office of Technology Assessment (OTA) was less than sanguine about the prospects of biotechnology industries. "To date," it reported, "most US biotechnology companies have no sales and have been losing money since their inceptions" (1991: 48). Although between January and May of 1991 biotechnology companies raised $3.6 billion in public equity and sold almost $18 billion in new stock (the highest five-month total in history), most analysts regarded the 1991 boom as short-lived, unlike earlier bull markets for biotechnology. By the end of May 1991, there were signs that the demand for stock was diminishing (Hamilton 1994; OTA 1991). Analysts variously attributed the buying spree to the US Food and Drug Administration's approval of new products, the durability of health-related stocks in hard economic episodes and a sudden explosion of demand following a three-year lull in stock market activity (OTA).

Already at the time of the OTA report several reasons for the decrease in venture financing of biotechnology were widely recognized. Among others, basic gene-splicing technology had become readily available to an increasing number of companies in the industrialized world. Product development was slower than expected, and returns on investment had not always been realized (OTA: 47-8). The OTA admitted, "Many early claims about biotechnology, seen in retrospect, were premature. Products have not been developed and marketed as quickly as previously thought possible, and many scientific and public policy issues remain to be settled" (3).

The September 26, 1994, issue of Business Week magazine had a cover exclaiming, "Biotech: why it hasn't paid off." A diagram accompanying the relevant article summed up the problem thus: "Too many companies are chasing too little capital, as key products bomb, pummeling stocks" (Hamilton 1994: 84-5). The body of the article explains,

After a decade of the highest-flying of America's high-tech industries, biotech faces a reckoning --and it's going to be ugly. The billions in investment have created an industry choked with copycat, capital-hungry companies lacking the critical mass of technology o survive. The vision that industry backers had of the path to riches no longer holds sway: Biotechnology, while immensely valuable, is not the shortcut to success in the drug game its advocates once thought it would be (84-5).

Bio/Technology magazine's survey of 14 agricultural biotechnology firms revealed that in 1994 their average R&D spending increased only 3.2%, compared to 43.6% in 1993 and 39.6% in 1992. Their reasons for cutting back included skepticism in equity markets, perhaps ceasing to fund R&D enlargement, and investors' pressure to introduce and sell products, forcing them to allocate more money to production and sales (Kidd 1995). Prospects seem somewhat better on the pharmaceutical front. Bio/Technology's survey of 191 "biopharmaceutical" companies found that R&D spending had increased 34.7% in 1994. However, this amount was small compared to the eighty-nine percent rise in 1993 and the seventy-one percent rise in 1992 (Glaser 1995). Fewer companies opened stock up for public sale in 1994 than in 1993: fourteen companies raising $274 million, compared to thirty-six firms raising $935 million (Coghlan 1995).

If biotechnology industries are to survive, it may be in part through consolidation, with fewer "dedicated" companies and more involvement of transnational corporations with broader industrial bases and bigger markets (85-6; OTA 1991: 53-7). Some biotechnology industry representatives put the blame on the investors, rather than problems inherent in the industries. Carl Feldbaum, President of BIO declared, "Biotechnology has been in a crisis," but he attributes it to investors' naïveté: their expecting too much too soon and responding en masse (Coghlan 1995: 7). First World governments continue to promote the biotechnology industries, irrespective of the market constitution. For those who wish to challenge the aims and power of biotechnology the prospects grow more daunting, and decisive action is needed.

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