Genes, Cells and Organisms are not Corporate Property

By Jonathan King and Doreen Stabinsky

The emergence of the biotechnology revolution is a defining aspect of the end of the 20th century. The breakthroughs in molecular genetics, biochemistry, and cell biology offer extraordinary new possibilities for preventing and treating disease, for a deeper understanding of the interactions of organisms with each other and their environment, and for entirely new manufacturing technologies. Intertwined with the development of biotechnology has been its rapid commercialization.

An unforeseen and deeply troubling aspect of this commercialization is the transformation of biological entities that are the products of hundreds of millions of years of evolution into private property. This is taking place through the radical extension of patent law to encompass gene sequences, cell lines, genetically modified organisms and even natural species. These profound changes in policy are being implemented through the administrative procedures of the US Patent and Trademark Office (PTO), outside of public debate or Congressional oversight.

The rapidity and range of this privatization is only just entering public consciousness. Myriad Pharmaceutical owns patents on the human genes damaged in breast cancer; Human Genome Sciences has patented the entire genomes of important bacterial pathogens affecting public health; Monsanto owns patents on genetically engineered soybeans and cotton varieties; Sequana Therapeutics has filed for patents on the cells and genes of indigenous tribes in New Guinea. Rice-tec corporation has obtained patents on the Basmati rice variety grown in India for thousands of years.

Such life patents represent a sharp departure from the historical traditions of human societies. Farmers have always owned the crops they grew, but they had no legal rights to restrict others from growing those crops. The Monsanto patent on transgenic cotton extends to all the progeny of such plants and allows Monsanto to prevent farmers from saving the seed of crops they have grown and planting them the next season. The cloning of Dolly was not announced until the Roslin Institute had filed patents not just for cloned sheep, but for all animals produced anywhere in the world by a similar process. Such private expropriation of fundamental biological resources reflects a qualitative change in access to basic biological knowledge and to the relations between human society and the natural world.

The consequences of this social transformation has been the subject of a series of recent books including Vandana Shiva's Biopiracy, (Boston, South End Press, 1997), Sheldon Krimsky and Roger Wrubel's Agricultural Biotechnology and the Environment, (University of Illinois), 1997; Jeremy Rifkin's The Biotech Century.(Tarcher/Putnam, 1998) and Martin Teitel's and Hope Shand's 's "The Ownership of Life"

A patent allows the owner to exclude others from using or benefiting from the patented invention, process or construct of matter. US patent law, by granting a monopoly for twenty years, allows the patent holders to prevent others from producing or utilizing the 'invention', even if for medical purposes or human welfare. This takes the form of infringement suits, injunctions against sales of products, and other forms of litigation, threatened or actual. Hundreds of millions of dollars worth of such suits are brought regularly as corporations and even universities manoeuvre for control of lucrative monopolies which follow from patent ownership.

US patent laws were originally written by Thomas Jefferson. Jefferson was an active plant breeder and corresponded with leading breeders in Europe. Nonetheless, the patent laws as developed by him excluded animals and plants from their coverage. Jefferson was clear that patents were a form of monopoly. He believed the role of patents lay not in the generalized protection of private property, but in the limited and specific purpose of ensuring that creative and inventive individuals were able to make a living, and thus continue to contribute to society. He wrote that whenever this monopoly was contrary to the public interest, the public interest would take precedence.

With the commercialization of plant breeding and seed production in the 1920's, breeders attempted to restrict competition through inclusion of ornamental plant and other hybrids under the patent laws. Resistance from consumer groups and farmers prevented this, but breeders were granted some "protection" by the Congress through the passage of separate legislation, the Plant Variety Protection Acts of 1930 and 1970. Organisms in general and their genes, proteins, or component cell lines, remained excluded from general patent monopolies.

This two hundred-year-old legacy was breached in 1980 with the granting of a patent for a genetically engineered bacterium by the US Supreme Court in Chakrabarty vs. US Patent and Trademark Office. The decision was very close (five to four) and was narrowly constructed with respect to genetically modified microorganisms. In the years following, under pressure from the pharmaceutical, biotech and agrotech interests, the PTO began issuing patents on genes, human cell lines and plant strains. US corporate interests have used the vehicle of GATT and the World Trade Organization to aggressively press for enforcement of life patents by other nations.

The criteria for the granting of patents under existing US patent law are novelty, utility and nonobviousness. Prior to the Chakrabarty decision patents were limited to true inventions of machines, novel processes, synthetic materials and related "compositions of matter'. Such 'products of nature' have historically been excluded from patent protection. Thus elements and minerals cannot be patented because they are found or discovered, and not invented. As biologists we are appalled at the claims that the determination of the nucleotide sequence of a gene represents a novel invention.

However, the fundamental issues are questions of social policy and not legal interpretation. The Constitution simply states that the Congress shall have the power to grant patents "to promote the useful arts". Patent laws are passed, modified and abrogated by the Congress just as other laws governing the country. They are means to social progress, not an end in themselves.

The intellectual property rights on human creative or scholar activity patents should not be confused with the "intellectual property rights" lawyers use in referring to life patents. Books, drawings, songs and other products of the human intellect are categories totally different from human genes or basmati rice plants which have evolved over hundreds of millions of years.

Life patents undermine our ability to reap the fruits of these scientific and technological advances through multiple paths.

Intereference with research and scholarship

The biotechnology revolution was the product of a broadbased biomedical research and training campaign launched by the Congress after WWII, and based in colleges, universities and medical schools throughout the nation. Essential to this public endeavor was the free communication and exchange of materials and ideas. Major scientific advances, such as the determination of the amino acid sequences that made up protein chains, were openly communicated and entered the public domain. The enormous inventiveness of this period occurred without patents.

Patent law requires that the subject of the patent has not been revealed as "prior art". Oral reports, abstracts, grant proposals and published papers all constitute prior art. Thus individuals or groups planning to file for a patent have to avoid public disclosure of the work prior to the filing of the patent claim. Patent attorneys regularly advise researchers to restrict presentations to colleagues, so as not to jeopardize planned patent submissions. The resulting undermining and reversal of the biomedical culture of open communication and exchange is one of the most destructive impacts of life patents.

Negative Consequences for Health Care and Medicine

In the health care field patents not only retard progress at the level of research, but interfere with the delivery of health care. The key commercial value of a patent is the ability to prevent competitors from developing or delivering a related (or superior) process or product and this holds for public and non profit institutions as well as other companies.

Thus when the Biocyte corporation obtained a patent on the use of blood cells from the umbilical cord in a variety of therapeutic situations, health care professionals responded " protesting..the granting of this patent to Biocyte corporation. We are also concerned that this patent may discourage and threaten activities of non-profit cord blood banks, clinicians, patients, parents and the volunteers who support them. (Nature, 383, 17, 1996).

Corporate spokespeople claim that, without patent protection, important therapies and technologies will not be developed. In fact, what patent protection ensures is not technological development, but suppression of competition. Patents are as often used to prevent the development of new technologies as to exploit them. Some of these barriers have recently been explored by Heller and Eisenberg (Science,Vol. 280, 1 May 1998, pp. 698-70). It is noteworthy than India, Brazil and other countries patent laws excluded pharmaceutical and other health care products from patenting, on the basis of protecting public welfare.

Food and Agriculture

Intellectual property rights on seeds deprive farmers of free access to an essential public good -- crop seed. Farmers for millennia saved the seed of their harvests for replanting the following year, and continue to do so even in the industrialized agricultural systems of the United States. Patents on seeds are a legal means to make sure farmers buy seed every year; Monsanto took legal action against some 100 farmers last year for planting saved seed from their genetically engineered varieties.

The problems of intellectual property protection on seed become magnified by the economic consolidation currently taking place in the seed industry. Monsanto and DuPont alone may now control half of the U.S. soy and corn seed markets. At the international level, the ownership situation is similar: in Argentina Monsanto owns 40% of the corn seed market; in Brazil, 30%. Monopoly control in an oligopolistic market is a sure recipe for higher seed costs.

Bringing the issues into the democratic process

The European Parliament, responding to the initiatives of the Greens, refused to accept patents on genes. The first vote on such legislation a few years ago ended in a decision against patents on life. Only the full mobilization of commercial interests in 1997 led to the set back of this effort. Just recently the Dutch Government formally appealed the decision to the European Court of Justice.

In Europe, South-east Asia and South America, there are significant social movements opposing life patents. Dramatic public demonstrations occurred in India in response to W. R. Grace's obtaining patents on the Neem tree, and these were followed by a vigorous battle in the India's upper parliament to resist the GATT intellectual property requirements.

The US government and the United Nations have recognized the necessity of protecting essential common resources from national sovereignty or private ownership. These include the oceans, the atmosphere, and the moon, The earth's life forms need to be in the same category. The first step is the open discussion of these questions outside patent courts, in colleges and universities, in professional societies, and in the US Congress.

The Blue Mountain Declaration

Issued at Blue Mountain, New York June 1995, by a coalition of 25 organizations copncerned with environmental protection, indigenous peoples and human right)

The plants, animals, and microorganisms comprising life on earth are part of the natural world into which we were all born. The conversion of these species, their molecules or parts into corporate property through patent monopolies is counter to the interests of the peoples of this country and of the world.

No individual, institution, or corporation should be able to claim ownership over species or varieties of living organisms. Nor should they be able to hold patents on organs, cells, genes or proteins, whether naturally occurring, genetically altered or otherwise modified.

As part of a world movement to protect our common living heritage, we call upon the Congress of the United States to enact legislation to exclude living organisms and their components from the patent system.

Jonathan King is Professor of Molecular Biology at MIT and Doreen Stabinsky is Asst. Prof of Environmental Science at California State University at Sacramento. Both serve on the Board of Directors of the Cambridge based Council for Responsible Genetics.

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