Patenting the Planet

Over the last decade and a half, the biotechnology industry has scored an impressive series of legal and policy victories, progressively expanding the scope of intellectual property laws. After gaining patent protection in the United States for genetically engineered micro -organisms, plants and then animals, the industry turned its attention abroad, and began working with the U.S. government to secure those market protections around the world. The success of the joint industry-U.S. government effort has allowed a handful of corporations who dominate commercial biotechnologies to stake far-reaching claims of ownership over a vast array of living organisms and life processes.

Proponents of patenting argue that it is designed to promote innovation by rewarding inventors of new technologies and that it is essential to enable companies to recoup their research investment. But there are clear winners and losers in the grab for life patenting. Biological resources have profound economic and social importance. As industrial patent systems extend across the globe, monopoly control over biological products and processes jeopardizes world food security, undermines conservation of biological diversity and threatens to further marginalize the world's poor.

Redefining human "invention"

The patenting of life forms represents a radical departure from he traditional scope of industrial patent law. In addition to the basic criteria for patenting - novelty, usefulness and non-obviousness - there is a well-established doctrine in patent law that "products of nature" are not patentable. With the advent of genetic engineering, however, it did not take long to redefine what is considered a human "invention" and legally patentable.

Over the course of a single decade, the U.S. government took giant steps to accommodate the corporate push to patent life. The U.S. Supreme Court ruled in the landmark 1980 case of Diamond v. Chakrabarty that genetically engineered microorganisms are patentable; the U.S. Patent & Trademark Office ruled in 1985 that plants (previously protected only by plant breeders' rights) could qualify under industrial patent laws; and the U.S. Patent & Trademark Office ruled in 1987 that genetically engineered animals are also patentable. As a result of these decisions, virtually all living organisms in the United States, including human genetic material, became patentable material, just like any other industrial invention.

But giant biotechnology companies want to sell their products across the globe, not only in the United States, so the United States and other industrialized nations have lobbied aggressively in recent years for a single, international intellectual property standard, based on the U.S. model. Their efforts bore fruit in the Uruguay Round of the General Agreement on Tariffs and Trade (GATT).

Historically, intellectual property laws have been largely left to governments, with different nations tailoring their patent laws to meet their own needs. Most developing nations (and some European countries) chose not to recognize patents on food, pharmaceuticals or products that meet other basic human needs.

In the GATT Uruguay Round, the United States and other industrialized countries raised intellectual property as a trade issue, pushing for "harmonization" that would bring everyone else's laws in line with theirs. The resulting GATT Trade Related Aspects of Intellectual Property (TRIPs) agreement obligates all GATT signatories, including developing countries, to adopt minimum intellectual property standards for plants and microorganisms. Under the threat of trade sanctions, many developing countries will be forced to adopt intellectual property systems that may be ill-suited to their needs and level of development.

The GATT TRIPs agreement has far-reaching implications, giving multinational corporations exceptional power and control in new markets and allowing them not only to collect royalties, but to set conditions under which developing nations can gain access to new technologies.

Rights for whom?

In the rush to promote exclusive rewards for "inventors" of new biological products and processes, corporations and governments in the industrialized world have conveniently ignored the contributions of "informal innovators" - generations of farmers and indigenous peoples who develop, conserve and use the biological diversity upon which all genetic technologies depend. Access to the biological resources nurtured and protected by small farmers is the life blood of commercial biotechnology.

Most of the world's biological diversity originates in tropical and sub-tropical regions of the developing world These areas are also the original homes for the staple crops grown and consumed by the vast majority of the world's population

The genes from plants, animals and microorganisms found primarily in the developing world are the strategic "raw materials" used to develop new food, pharmaceutical and industrial products. But these genes are seldom "raw materials" in the sense of, say, minerals, because they have been selected . nurtured and improved upon by generations of farmers and indigenous peoples over thousands of years.

Over the past 12,000 years, farmers have selected and domesticated all the major food crops on which people rely today. Fresh infusions of exotic germplasm are vital for the ongoing maintenance and improvement of agriculture To maintain pest and disease resistance in food crops, for instance plant breeders draw on new genetic material to stay one step ahead or pest and disease mutations and adaptations. It is difficult to overstate the value of exotic germplasm to plant breeding and genetic engineering in the industrialized world.

Similarly, traditional medicines, although based on natural products, are products of human knowledge. An estimated three quarters of all plant-derived prescription drugs were discovered as a result of their prior use in indigenous medicine. The annual world market value of these medicines is estimated at $43 billion, according to Darrell Posey in the August 1990 Anthropology Today.

There is increasing recognition worldwide that the indigenous knowledge of thousands of human cultures is crucial to understanding, utilizing and conserving biological diversity for agriculture, human health and sustainable development. Unfortunately, international cooperation to conserve biodiversity and to ensure its equitable and sustainable use is being undermined by current patent trends. Legal claims of ownership over biological products and processes that are based on cultural innovations spanning millennia neither recognize nor reward the critical contributions of informal innovators. This emerging system of "biopiracy" most severely affects farmers and poor consumers in the developing world, who are least able to pay royalties to use products which are based on the biological resources and knowledge of their own culture.

The patent rush

The biopiracy trend has picked up steam in the last several years, with biotech companies applying for, and receiving, an increasing number of broad patents based on genetically altered products.

• In 1993, genetic engineers from a U.S. subsidiary of the South Korean pharmaceutical company Lucky Biotech Corporation and the University of California received U.S. and international patents for any genetically engineered, super-sweet proteins derived from a West African plant known as thaumatin. The thaumatin plant protein, 100,000 times sweeter than sugar, is the sweetest substance known. It grows in the humid tropical forests of West Africa, where local people have used if for centuries as a sweetener and flavor enhancer.

  A low-calorie, natural sweetener that can be inserted into the genetic makeup of any fruit or vegetable has tremendous market potential for Western biotechnology firms. In the United States alone, the market for low-calorie sweeteners is $900 million per year. But West African people will never receive royalties on sales of goods derived from thaumatin. In fact, as consumers, they may end up paying royalties for products that owe their existence to the work of their ancestors.

  Lucky spokesperson Yong Ji says the company has not encountered any controversy over its patent on the African genes. "The company has not made recent progress in the commercial application of the super-sweet genes," she adds.

• Even biotechnology industry insiders were shocked in late 1992, when Agracetus, Inc., a biotechnology subsidiary of the agrochemical giant W.R Grace Corporation, received a patent for all genetically engineered or "transgenic" cotton varieties.

  This first-ever "species patent" gives a single corporation the right to decide when and if it chooses to license its technology, for how much and under what conditions, until the year 2008. In other words, genetically engineered cotton varieties cannot enter the commercial marketplace without permission and payment of royalties to W.R. Grace. The company has licensed its patent for an undisclosed sum to Monsanto and Calgene; both of these companies are developing transgenic cotton seed for commercial sale.

  Licensing fees and royalties may be prohibitive for many scientists, however, thus foreclosing innovation in this high-tech field by any but a handful of corporations who have the resources to file patents and license new technologies controlled by others. Dr. Jerry Quisenberry, director of the U.S. Department of Agriculture's Cotton Systems Research Laboratory in Lubbock, Texas, oversees the U.S. government's largest program on the molecular biology of cotton. Reacting to W.R Grace's cotton patent, he said, "Public research on cotton, at least at the molecular level, will have to come to a screeching halt."

  The impact of W.R. Grace's broad patent on cotton is not limited to the United States. Agracetus has applied for similar patents in India, China, Brazil and Europe. While a company statement claims "there are no assurances that any broad claims will be issued," the countries where it has filed patent applications account for 60 percent of the world's cotton production.

  To defuse critics who charge the company with monopolistic ambitions, Agracetus recently announced that it will offer free research licenses to academic and government researchers. According to a December 1993 company policy statement, "Agracetus policy is to make research licenses available, free of charge, to all academic or U.S. Department of Agriculture researchers upon request to assure their publicly funded research will be unaffected by this patent. As it has never been the mission of these parties to directly commercialize technology, this license will allow these parties to continue their work unaffected."

  Cotton is primarily a developing world crop. It was first domesticated and improved by farmers in Central and South America, making the claim that Agracetus "invented" transgenic cotton hollow - and unjust Modern plant breeders and genetic engineers are simply building on the accumulated success of generations of farmers. Under industrial patent law, however, it will be illegal for farmers to save harvested transgenic cotton seed without permission from, and payment of royalties to, W. R Grace or its licensee.

  Unlike traditional industrial inventions such as light bulbs or sewing machines, plants and animals are capable of reproducing. Saving and re-planting harvested seeds that have been patented, or selling the offspring of patented livestock, is an infringement of patent law. Farmers who buy patented seed are thus forced to return to the commercial marketplace to purchase new seed each year, ending the age-old practice of using farm-saved seed. While enforcing such laws may seem unlikely, U.S. seed industry giants Pioneer and Asgrow (a subsidiary of Upjohn) have brought lawsuits against dozens of U.S. farmers for re-selling proprietary seeds in recent years.

• Another species-wide patent- this time a food crop - was granted in March 1994 when W.R. Grace received a European patent on all transgenic soybeans. The company has a similar patent pending in the United States. Scientists and activist groups have described Grace's soybean patent as a threat to world food security because it could effectively halt all high-tech research on one of the world's most important food crops.

  According to an Agracetus statement, "Agracetus invented a technique which makes possible the insertion of genes into any soybean variety. Until the time of this invention, there was no alternative process to achieve this objective. This capability gives researchers a powerful new tool to improve the qualities of soybean through genetic engineering. ... Such advances will be critical to maintaining and expanding the world's food supply."

  But Dr. Geoffrey Hawtin, director-general of the Rome-based International Plant Genetic Resources Institute, says the patent may seriously interfere with future research efforts and with researcher's attempts to further improve soybean quality, "The granting of patents covering all genetically engineered varieties of a species, irrespective of the genes concerned or how they were transferred, puts in the hands of a single inventor the possibility to control what we grow on our farms and in our gardens," he charges. "At a stroke of a pen, the research of countless farmers and scientists has potentially been negated in a single, legal act of economic highjack."

Farmer's Rights

People's organizations, farmers and scientists around the world are actively protesting acts of biopiracy and raising concerns about the impact of life patenting on agriculture, rural societies and biological diversity. In late 1993, demonstrations in India against the intellectual property provisions of the new GATT drew more than 500,000 farmers. W.R. Grace's "species-wide" patents are now in the process of being challenged and re-examined in Europe, the United States and India.

Increasingly, many are re-evaluating the role of innovation in society, and seeking alternative ways to foster the goal of developing and disseminating new technologies. A June 1994 paper published by the International Development Research Center of Canada entitled "People, Plants and Patents" suggests important guiding principles in this regard. "[I]nnovation strategies should promote decentralization, diversity and democracy at all levels, rather than only promoting centralization, uniformity, and control. Current [intellectual property] systems are ineffective in supporting community-level innovation," it says.

A key to any satisfactory alternative will be multilateral funding, under the auspices of the United Nations, that will recognize, reward and protect the innovations of farmers, indigenous peoples and their communities. The United Nations' Food and Agriculture Organization (FAO) has made important progress toward this goal. It now recognizes that farmers-past, present and future - contribute to the conservation, use and development of plant genetic resources and that they should be recognized and rewarded for those contributions.

Although the general principle of "Farmer's Rights" was adopted by the FAO in 1991, it has yet to be implemented.

The FAO and contracting parties to the Convention on Biological Diversity are exploring how a fund could be established to implement Farmer's Rights as a protocol to the Biodiversity Convention. In practice, such a fund would not make payments to individual farmers or communities. Instead, it would support specific programs and projects, such as training plant breeders or constructing gene banks, in order to promote rural development and conserve and enhance agricultural biodiversity. The aim would be to allow even the poorest countries to develop indigenous capacity to exploit their own genetic resources and to develop greater self-reliance in food production and conservation of biodiversity.

As the inequities and controversies resulting from life patenting seep into pubic consciousness, critics in the Third World and the industrialized countries are increasingly winning adherents to the view that intellectual property rules covering living materials must be rethought. Intellectual property laws should be designed to promote innovation, but the system is recklessly out of control. Instead of promoting innovation, life patenting will ultimately stifle the free flow of information and genetic resources that are vital to agricultural development. If present trends continue, life patenting will compound existing inequities between North and South, and further marginalize the world's poor.

Hope Shand is research director of the Rural Advancement Foundation International.

Examples of Broad Patent Claims Patent Holder (Patent Number): Claim W.R. Grace & Co. (US 5,159,135): Species-wide patent on all transgenic cotton. W.R. Grace& Co. (EPO 0301749): Species-wide patent on all transgenic soybeans. W.R. Grace& Co. (application for U.S. patent): Species-wide patent on all transgenic soybeans. Calgene, Inc. (US 5,188,958): Brassica transformation patent-covering any plant in the Brassica family (rapeseed, broccoli, cauliflower, cabbage and brussels sprouts) engineered using the Agrobaceterium method. Plant Genetic Systems (US 5.254,799): All plants genetically engineered to contain Bacillus thuringiensis (Bt) genes using the Agrobacterium techniques of transformation. Bt is the most widely used source of natural insect resistance in transgenic crop R&D. DNA Plant Technology (US 5,290,687): All plants genetically engineered to express higher levels of chitinase. Chitinase is a natural enzyme in plants that wards off fungal diseases. Lucky Biotech Corp. and University of Californa (US 5,234,834): All plants engineered to express super sweet thaumatin genes.

Extracting Human Resources Acts of biopiracy are not confined to plants, livestock and exotic microbes. Perhaps the most outrageous example of biopiracy involves patent applications by the U.S. government on the human cells of indigenous peoples. In 1993, the Rural Advancement Foundation International discovered that the U.S. government had applied for U.S. and international patents on a virus derived from the cell line (cells that are capable of sustaining continuous, long-term growth under artificial conditions) of a 26-year-old Guaymi Indian woman from Panama. A blood sample was taken from her by a National Institutes of Health researcher who subsequently established the cell line. The DNA sample was of interest because some Guaymi carry a unique virus containing antibodies that could prove useful in AIDS and leukemia research. The scientist who took the DNA sample from the Guaymi woman followed standard regulations for what is known as "oral informed consent." But informed consent does not require that the research subject be told that genetic material derived from their DNA will be patented, or that someone stands to profit if a commercial product should someday be developed from the patented cell line. Representatives from the Guaymi General Congress in Panama were shocked to learn that the U.S. government could apply for patents on the human genetic material, let alone the cell line of a foreign national. The Guaymi Indians do not object to medical research or to making contributions that will improve the human condition, but they were outraged that the U.S. government would seek to monopolize and potentially profit from biopirated genes. Isidro Acosta, president of the Guaymi General Congress, says, "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." As a result of protests by the Guaymi Congress, other indigenous peoples organizations, non-governmental organizations and the European Parliament, the U.S. government silently withdrew its patent claim late last year. But the issue is far from resolved. In January 1994, two more patent applications, again in the name of the U.S. government, were filed in Europe. This time, the cell lines come from citizens of the Solomon Islands and Papua New Guinea. The cell lines are now on deposit at the American Type Culture Collection in Washington, D.C. But since patent claims are still pending, access to these materials is restricted - even to the governments of Papua New Guinea and the Solomon Islands. Private ownership of human biological materials raises many profound social, ethical and political issues. Some have dubbed the patenting of human cell lines of indigenous peoples a form of "bio-colonialism." If these cell lines, or products derived from them, should someday result in commercial products, U.S. courts have ruled that the people from whom the genetic material is taken do not have rights of ownership over their own cells after they have been removed from their bodies. There is no international protocol to protect human subjects from patent claims and commercial exploitation. And there is no mechanism to compensate individuals or communities from whom DNA samples were taken. In a March 1994 letter to the Ambassador of the Solomon Islands, U.S. Secretary of Commerce Ronald H. Brown dismissed the concems of foreign governments about the patenting of human cell lines. "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." - H. S.

Patenting Human Life: Who Draws the Line? On October 24, 1992, the New York Times reported that Dr. Robert Stillman of George Washington University had successfully cloned human embryos. The article pointed out that Stillman's work was "not a technical breakthrough," simply the application of widely known animal cloning techniques to human embryos. Livestock embryos are, in fact, routinely cloned by bioengineers. The Thirteenth Amendment of the U.S. Constitution, which prohibits slavery, forbids any grant of property rights over a human being. But science and technology are moving much faster than legal systems, blurring traditional boundaries and definitions. Bioengineers have inserted foreign genes, including human genes, into the chromosomes of many animals, including pigs, sheep, goats and chickens. In the future, genetic engineering will enable scientists to intermingle the genetic material of humans and animals to produce human-animal hybrids. "It may be possible," Michael D. Rivard wrote in the June 1992 UCLA Law Review, "to patent and to enslave human-animal hybrids who think and feel like humans but who lack constitutional protection under the thirteenth Amendment." Given that animals containing human genes are already patentable, it may be possible to patent human-animal hybrids. Some legal scholars and bioethicists are calling on U.S. courts to begin developing a legal theory of" constitutional personhood" that can be applied to genetically engineered species and afford them protection under the U.S. Constitution. Dr. George Annas of Boston University, in a Hastings Center Report entitled "Of Monkeys, Man and Oysters," asks, "Since cloned human embryos are not 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?" � - H.S.