TWO years ago, for the first time in history, an applicant for a U.S. patent tried to establish monopoly ownership over the genome of a living person.
It was in August 1993 that Pat Mooney of the Rural Advancement Foundation International (RAFI) was examining a patent database primarily for agricultural information when he came across an application filed by the U.S. Secretary of Commerce on the cell line of a 26-year-old Guaymi Indian woman from Panama. A cell line is a group of cells taken from a human body that is capable of being sustained and grown in laboratory culture media, and is therefore said to be "immortal;" a line of cells contains the complete genetic code, the genome, of an individual.
These cells were believed to contain special anti-viral qualities. Although two American men were listed in the application as "inventors," it is not at all clear that their actions in taking the woman's blood when she went to the hospital for treatment and isolating these cells amounts in any sense to what the ordinary American (no less Thomas Jefferson, creator of the Patent Office) would consider an "invention."
Mooney immediately contacted the Guaymi - who, of course, had no idea they were candidates for monopolization - and also alerted a group of international activists who had gathered in Geneva that September under the auspices of the U.S. Biotechnology Working Group.
The Guaymi demanded that the U.S. withdraw its patent claim and return the cell line to the tribe.
RAFI and other activist groups supported the Guaymi, including bringing their president to Geneva to protest the patent claim at a number of venues - the World Intellectual Property Organization, an intergovernmental meeting of the parties to the Biodiversity Convention, and at the secretariat of the GATT trade organization. European Greens spearheaded opposition in the European Parliament, and in early November of that year, the U.S. government withdrew its claims.
The Guaymi tribal president reflected, "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."
Subsequently, however, the U.S. government has filed two other patent applications on human cell lines of indigenous peoples - from the Solomon Islands and from Papua New Guinea. Brushing off a letter of protest from the ambassador of the Solomon Islands, U.S. Commerce Secretary Ron Brown stated, "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 source of the cells that may be the subject of a patent application."
Brown's department houses the U.S. Patent Office, which has been creating its own "law" on this subject, providing sufficient cover for Brown to dismiss such concerns.
Genetic engineering has enabled scientists to turn some barnyard animals, such as cows and sheep, into miniature chemical factories, producing valuable human proteins in their milk. Some ethical objections have been raised to the insertion of human genes into animals, both by the animal welfare movement as well as by ethicists and religious leaders.
Amazingly enough, on Feb. 10, 1988, a European patent application was filed by Baylor University of Texas, which would include the genetic alteration of a human female so that she could be similarly used as a drug factory, facetiously labeled by European activists as the "pharm-woman."
The British attorney who represented Baylor said the application was specifically drafted broadly because "Someone, somewhere may decide that humans are patentable" and therefore he wanted to make sure that they had monopoly rights to the production of important pharmaceuticals in human female breasts.
As the Guaymi situation indicates, human communities do have small, and sometimes significant, variations among the estimated 100,000 genes in our body cells. For example, it is well known that the residents of the village of Limone in the Italian Alps have significantly lower incidence of heart disease than villagers in adjacent valleys. Inbreeding of relatively isolated biological populations (plant or animal or human) can produce and maintain such variations.
On this basis, U.S. scientists are seeking funding for a grandiose plan called the Human Genome Diversity Project which would sample approximately 10,000 to 15,000 human beings living in 722 indigenous or isolated communities. At an overall cost of approximately $35 million, the project will spend more money gathering each individual blood sample than the per capita GNP in any of the world's poorest 110 countries.
Although the scientists claim to be driven by purely intellectual curiosity, it doesn't take a lot of smarts to realize that if substances like the Limone heart disease preventative were isolated the pressures to make them commercially available to other people would be intense. Presumably the patenting and marketing of such portions of the human genome would be inevitable, no matter what the current scientists, naively or disingenuously, state.
This proposal has elicited much opposition from indigenous peoples and their supporters in developed countries. Scientists in the project are anxious to start collecting these "Isolates of Historic Interests," because "They represent groups that should be sampled before they disappear as integral units so that their role in human history can be preserved."
To put this project in perspective, note that a First World society which does not provide indigenous communities with even the rudiments of public sanitation, preventative medicine or curative treatments (allowing preventable diseases such as cholera and polio to be endemic) is going to ask these communities to give us something which may be beneficial for our health care.
After having dominated most of the mineral and vegetative resources of indigenous peoples, we are now talking about turning on their very bodies as the ultimate resource to exploit.
Indigenous peoples around the world have been united in their condemnation of the Human Genome Diversity Project. Tadodaho, chief Leon Shenandoah of the Council of Chiefs of the Onondaga nation, wrote the National Science Foundation, "Your process is unethical, invasive and may even be criminal. It violates the group rights and human rights of our peoples and indigenous peoples around the world. Your project involves the very genetic structures of our beings."
Planning for the Human Genome Diversity Project is still going forward despite such opposition.
Genetically engineering slight variations in a species genome has given rise to numerous patent applications. Many people who think patent protection is justifiable in such situations, both over the altered genome and its new products, are still shocked by the bold step of a number of corporations trying to expand the monopoly by claiming patentability over the genome in totality.
Such "species patents" include claiming exclusive rights over the 90-plus percent of the genome that nature evolved, the myriad birds and insects produced by cross fertilization, and which reflects millennia of cultivation and alteration by indigenous peoples. Although such patents have been issued (for example, to Agracetus Corp. for cotton and soy) the U.S. and some foreign patent offices are reconsidering them in light of concerns raised by citizens and scientists. In this context, a recent study estimates that the annual profit to developed countries from the use of agricultural genetic resources from the Third World ("indigenous intellectual property") is between $4 billion and $5 billion.
Another attempt to extend the notion of a patent monopoly is the application for patents on specific human genes and on human gene fragments whose function is not even known. This situation, going well beyond the facts in the Moore case, is sufficiently controversial even among scientists that the primary applicant (a researcher at the National Institutes of Health) was forced to leave the government; he is now continuing these patenting efforts under corporate auspices.
Scientists in the International Human Genome Organization, however, have recently issued a statement supporting the patenting of human DNA. They only oppose the patenting of partial genes or where the biological function of the gene sequence is unknown; they categorize this work as "mechanical" and "routine," certainly not rising to the level of innovation which should be associated with a patent.
On Oct. 24, 1992, newspapers reported that a researcher had successfully cloned human embryos. This was really not a technical breakthrough because it was simply the application of widely used animal cloning techniques to different mammalian embryos - human. Dr. George Annas of Boston University observed: "Since cloned human embryos are persons protected by the Constitution and theoretically at least could be as `immortal' as cloned cell lines, could a particularly `novel' and `useful' human embryo be patented, cloned and sold?"
"Bioprospecting" is a modern day gold rush in which ethno-botanists and other scientists are combing the farms, rain forests and jungles of the Third World looking for species that might lead to improved Northern Hemisphere agriculture or produce valuable pharmaceuticals. A World Bank official gave as an example the traditional medicines utilized within the Ethiopian Coptic Church. "Let's screen that knowledge stock," he suggested, and "explore how it might be commercialized." The U.S. government is funding five major industry-university consortia which have platted their stakes in developing countries. Although some talk is heard about giving a portion of the patent royalties to the indigenous people whose community wisdom is being expropriated, such a viewpoint is yet another form of imperialism. In indigenous societies, this biological knowledge is owned collectively rather than being an individual monopoly (although it may be preserved for the community by individual shamans). Should we insist that these communities overthrow their communitarian cultural/legal systems of millennia and adopt a privatistic Northern Atlantic one instead?
Strong responses to such arrogance and insensitivity are beginning to be evident. On March 1 of this year, the European Parliament voted to ban the patenting of life forms. On Gandhi's birthday in October 1993, a half-million Indian farmers demonstrated at the offices of multinational giant Cargill, protesting the patenting of seeds which had been used in their communities for thousands of years, and objecting to the agricultural and intellectual property provisions of the GATT. And a recent meeting of indigenous peoples in Fiji called for establishing a Life Forms Patent-Free Zone in the Pacific covering bioprospecting and human genetic research; a treaty to achieve these ends is currently being drafted.
The bio-tech industry's arguments in favor of patenting life forms fall into two main categories, both varieties of a claim that the patent monopoly provides fiscal incentives necessary for "progress." These are:
-- Business is risky and without the promise of patentability the industry will not be able to attract the necessary capital for research, development and production;
-- Without patents, society would have to forgo new drugs and lives would be lost and unnecessary pain prolonged.
Given these plausible claims, why did the American Medical Association conclude last month that "There is no empirical evidence to support the claim that the patent system is necessary to stimulate innovation."?
First, we have to understand that the bio-technology industry has been enormously subsidized by government on all levels, even without considering the existence of the patent monopoly as an additional form of support. Almost all of the basic genetic engineering research has been supported by the federal government, either directly (for example through grants from the National Institutes of Health) or indirectly (by allowing tax write-offs for private donations for this purpose, such as the $12 million gift by Bill Gates which lured geneticist Dr. Leroy Hood to the University of Washington).
Most of the laboratories on university campuses (where almost all the original work was done) were built with federal funds. Most of the younger researchers were supported on scholarships and fellowships by the NIH. Since citizens have made the investment which produced this new technology, why aren't the results considered public property available to anyone?
Even the Agricultural Biotechnology Council (an industry-government-university consortium) has noted that a public ownership mechanism - which has been used occasionally by the government - "has the advantage of stimulating the innovative activity without granting anyone a right to restrict its diffusion to others, as do grants of monopoly rights like patents."
Of course, in an era when the notion of privatization is running amok, advancing this argument may seem foolhardy; nonetheless, it is eminently sensible and just.
A second consideration is that a great deal of the work occurring in the private sector consists of relatively small modifications to the enormous body of knowledge created by public funding or developed communally over the millennia. Shortly after the Supreme Court decision, Dr. Anand Chakrabarty told People magazine, "I simply shuffled genes, changing bacteria that already existed. It's like teaching your pet cat a few new tricks." And the grand Jeffersonian scheme that knowledge would be widely shared and made available to all (to provide the basis of yet additional inventions) has in fact been thwarted by the modern patent system in which the talents of the good patent attorney are enlisted in order to disclose as little as possible in the body of the patent document. Why let your competitors know exactly what you are doing if you can get away with not telling them?
The free exchange of scientific information in biology departments and scientific meetings has been substantially affected by a reluctance to talk about one's work and by delays in publications and lectures, until the patent application is filed; academic colleagues have been transformed into industrial competitors.
In the words of the NABC, "The openness and free flow of ideas so important to the development of knowledge is slowed by this atmosphere of safeguarding information in the hopes of making it proprietary."
The patenting of a drug may, in fact, restrict the ability of ordinary people to gain access to medication because the price may be artificially inflated due to the monopoly. This was clearly the case with AZT, the first anti-HIV drug put on the market (developed with federal funds by the National Cancer Institute but marketed under a special statute giving patent rights to private distributors).
Finally, much of this discussion collapses into fundamental questions of ethics. Is a gene part of "life" or merely a bit of chemical? Do we care whether the natural world is being desacralized by transformations of intricate organic interrelationships within ecosystems into isolatable commodities which can be exclusively fenced off and exchanged to the highest bidder?
This spring, American leaders of many religious denominations - Protestant, Catholic, Jewish, Muslim and Buddhist - gave voice to the sentiment which most of their congregants know intuitively: it is unethical to patent life forms. Life patenting is not an issue which pits liberals against conservatives. Rather, elements of both the left and the right are raising concerns about the directions which technocrats (in the Patent Office, among venture capitalists, and on campuses) are taking society. Many voices are increasingly suggesting that it is time to step back and evaluate what is happening.
A recent essay in the New York Times marking the passing of Dr. Jonas Salk discussed the conquest of polio and noted that the March of Dimes prohibited patenting or receipt of royalties on the results of its research projects. The late TV commentator Edward R. Murrow, in an interview occasioned by the immense public excitement created by the trials of the vaccine, asked Salk who would control the new pharmaceutical. Salk replied "Well, the people, I would say. There is no patent. Could you patent the sun?"
Philip L. Bereano is Professor of Technical Communication in the College of Engineering of the University of Washington. He is a Seattle community activist specializing in technology-public policy issues. He wishes to acknowledge the work of colleagues around the world which has contributed to the ideas in this article. This is one essay in an occasional series on technology policy.