BODY AND SOUL: 
The Price of Biotech

By Philip L. Bereano
Special to The Times
(first of two parts)
The Seattle Times, Sunday, August 20, 1995, p.B5


In December of 1994, Seattle businessman John Moore traveled to Europe. He went to Brussels to visit the European Parliament; he visited Munich and took in the European patent office; and in Geneva, by the shores of the lake, he spent several hours at the World Intellectual Property Organization. These are not usual stops for a traveler's itinerary, and indeed, John Moore was not on vacation. He was in Europe because of what happened to him in 1976 when UCLA doctors removed rare "hairy cell leukemia" cells from his spleen and then developed a line of cells which produced valuable antibacterial and cancer-fighting proteins.

Of course, Moore had signed a surgery consent form which included fairly standard language allowing research to be done on his discarded tissues. But after the doctors received a patent on the so-called "Mo cell line" in 1984, Moore sued, alleging at the very least he should receive a share of the profits (potentially several billion dollars) on the grounds that-if one wanted to view it in such a light-every individual has a property right in their own body parts. In July of 1990 the California Supreme Court denied the existence of such a right of control over our own bodies (although it allowed John Moore to sue his doctors for a breech of fiduciary duty in failing to inform him of the potential commercial value of his cells). John Moore, as the only human known to have been patented in whole or in part, went to Europe last winter to lobby. The European Parliament was considering whether or not to accept a Directive from the Executive branch of that multi-nation political entity which would have allowed the patenting of life forms, including human parts. And, in an historic vote, on March the 1st of this year, the Parliament rejected such patentability by 240 to 188. At the same time that the biotech industry is rushing ahead with myriad patent applications, the vote in Europe is yet another example of widespread concern among the general public regarding the commodification of life forms. Patenting, formerly a sleepy preserve of corporate engineers, individualistic sole inventors, and exceptionally high paid lawyers, is becoming a subject of general political discourse.

Background

Despite the fact that Thomas Jefferson was the master of a large plantation and thus a breeder of plants and animals (as well as being a scientist and inventor himself), there's no reason to believe that when he drafted America's first Patent Act in 1793 that he intended it to cover life forms. Jefferson was quite clear, however, that he viewed the concept of patent monopolies as a necessary evil which could be tolerated in order to insure that "ingenuity should receive a liberal encouragement." Patents were also intended to foster the widespread dissemination of technical information which is "new" and "useful" and "not obvious" to practitioners in the field.

Jefferson was not one to confuse means and ends, and there is no doubt that the patent system was envisioned only as a means to increase the knowledge available to the public and secure good fortune to the Commonwealth. Among the over five million patents which have been issued under Jefferson's system, there have obviously been a number which have significantly spurred the American economy.

But for almost 200 years the idea that general patents could cover life forms was viewed as ridiculous; indeed, Congress refused to include coverage for plant varieties under these statutes and enacted specific (and much more limited) protection schemes for new plant varieties in mid-20th-century. In 1971, the General Electric Corporation and one of its scientists, Anand Chakrabarty, filed a patent application for bacteria which had an enhanced propensity to digest oil hydrocarbons. Although getting bugs to eat oil seems like a neat trick, the Patent Office initially rejected the application. The case was appealed to the courts. The Supreme Court had recently issued an opinion noting that "we must proceed cautiously when we are asked to extend patent rights into areas wholly unforeseen by Congress." However, it ruled in 1980, in a 5 to 4 opinion by Chief Justice Warren Burger, that the oil-eating microbe was not a product of nature but a "human-made invention." Whether it was alive or inanimate was not seen as the major criterion. The dissent by Justice Brennan, urged judicial restraint and noted that it was up to Congress, not the courts, to decide whether the scope of patentable matter should be extended.

All nine of the justices agreed that this was a narrow ruling, and the commentators were also essentially unanimous in the view that patentability of microbes might be one thing but monopolizing plants and animals (no one was even thinking of humans at that time) was beyond the pale. With no further guidance from Congress or the courts, the US Patent Office has run off on its own expanding the Chakrabarty ruling in many directions. In 1985, it decided that plants, seeds, and plant tissues could be patentable, and in 1987 all "multi cellular living organisms, including animals" were held patentable (this last ruling by the Patent Commissioner, by specifically excluding human beings from patentability, did acknowledge that there was an ethical issue involved in the patenting of life). The Thirteenth Amendment (outlawing slavery) may be seen as a bar to the patenting of humans; nonetheless embryos and fetuses and human body parts all appear capable of being monopolized under these Patent Office rulings. And now there are even attempts to patent whole human beings and their genomes.

The Geneticization of Society

Although there has always been a recognized public policy exemption to patentability (for example, nuclear devices are not patentable, under the Atomic Energy Act of 1954), one has to ask what ideological currents are gaining strength in America to permit such an unusual notion as the ability to have exclusive ownership of life forms. Genetics is increasingly being presented to the American public as a mysterious realm of knowledge which is now coming under human control, presumably for our economic and social betterment. "We used to think our fate was in the stars. Now we know, in large measure, our fate is in our genes," is the way this ideology has been formulated by James Watson, the Nobel laureate who participated in the discovery of the DNA double helix. This world view-which magnifies the claims to power by scientists and is trumpeted in the media-ignores the complex interactions within an organism and between an organism and its environment, as well as the social and political and economic factors that contribute to shaping life patterns.

But the biotechnology industry has succeeded in presenting itself as the next shining hope for America's economic development (along with infomatics--the computer/information industry). Together with other high tech industries, it has succeeded in making some substantial alterations in public consciousness, laws, and programs which directly benefit its own interest. These include such elements as: the enactment of the Technology Transfer Act enabling private entities to apply for patents on research which was largely funded by the government; trade negotiations such as GATT (the main purpose of the last set of negotiations-called the "Uruguay round"-was to bring global harmonization to specific areas of trade including "intellectual property rights"); tax write-offs and other governmental subsidies; and the Biodiversity Convention, which is concerned with the international legal aspects of genetic resources (the raw base of power over these important resources can be seen in the definition of the owner of genetic material-for example, a tropical medicinal-as either the country in which the species grows naturally or the country which houses a germ bank to which the germ plasm was taken and stored artificially).

Other societies have more explicit public policy examination of the patentability of life forms and products. For example, the patent laws in Brazil, India, and Argentina forbid the patenting of pharmaceuticals on the grounds that drugs are of such great importance that no one should have the right to monopolize them. Columbian researcher Dr. Manuel Patarroyo recently gave the World Health Organization exclusive royalty-free rights on an antimalaria vaccine he developed; "We wanted to do this for the benefit of humanity," he explained. The European viewpoint is greatly influenced by the Napoleanic concept that denies patentability to subject matter which is contrary to ordre public, (fundamental moral precepts essentially acknowledged universally). In Europe, too, the more explicit acknowledgment of a colonialist past may play a role in shaping public consciousness; according to a Dutch member of the European Parliament from the Green Party "Ninety percent of the genetic resources which are used in our agricultural production come from the Third World. We have never asked if we ought to pay anything for them. And now for the biotechnology industry to demand monopoly property rights over them is utterly unjustifiable. Whether wild species or crop plants, genetic resources are the common heritage of humankind. All farmers must be guaranteed free access to them."
 

Why Say No

According to GRAIN (Genetics Resources Action International), a European nonprofit organization promoting sustainable agriculture throughout the world, there are "12 reasons to say no to life patents." With patenting: John Moore's journey successfully limited the heedless patenting of life forms in Europe. On this side of the Atlantic, however, more people need to insist that our policy makers address the social and ethical issues raised by the biotech industry's inappropriate attempts to monopolize life.

Philip 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 colleagues around the world whose work has contributed to the ideas in this Op Ed. This is one essay in an occasional series of articles on technology policy.