|
|
Patenting Humans?
Robert Johnson (johnsorl@COLORADO.EDU)
Fri, 25 Aug 1995 15:40:14 -0600
Seattle Times OP Ed
More Patent Nonsense
(second of two parts)
Philip L. Bereano
In August of 1993, 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 US
Secretary of Commerce on the cell line of a 26-year old Guaymi Indian women
from Panama. (A cell line is a group of cells taken from a human body that
are capable of being sustained and grown in laboratory culture media, and are
therefore said to be "immortal;" a line of cells contains the complete
genetic code, the genome, of the individual from whom the cells were taken.)
Thus, for the first time, an applicant (outrageously, an arm of our own
government) was attempting to establish monopoly ownership over the genome of
a living person. These cells were believed to contain special anti-viral
qualities. Although two individual 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) would consider as "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
US Biotechnology Working Group. The Guaymi demanded that the US 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 WIPO, an intergovernmental
meeting of the parties to the Biodiversity Convention, and at the secretariat
of the GATT trade organization. The European Greens spearheaded opposition
in the European Parliament, and in early November of that year, the US
Government withdrew its claims.
The Guaymi 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, it has been found out that the US 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, US 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 US
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 human ethicists and religious leaders. Amazingly
enough, on February 10th 1988, a European patent application was filed by
Baylor University 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 that 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, US scientists are seeking funding
for a grandiose scheme called the Human Genome Diversity Project which would
sample approximately 10-15,000 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 persons 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 HGDP 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 HGDP. In the words Tadodaho, Chief Leon Shenandoah, of the Council of
Chiefs of the Onondaga nation sent to 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 many 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+% of the genome which nature evolved, which 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 for cotton and soy) the US and some foreign patent
offices are reconsidering them in light of concerns raised by citizens and
scientists. In this context, it is interesting to note that 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 $4-5 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 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 October 24th, 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 ethnobotanists and other
scientists are combing the farms, selvas, and jungles of the Third World
looking for species that might lead to improved Northern 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 US 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 1st of this year, the European Parliament voted to ban the
patenting of life forms. On Gandhi's birthday in October of 1993, one half
million Indian farmers demonstrated at the offices of muti-national 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 biotech 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: (1) 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; and (2) without patents, society would have to forego new drugs
and lives would be lost and unnecessary pain prolonged. Given these
seemingly 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 of all, we have to understand that the biotechnology 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 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
researches were supported on scholarships and fellowships by the NIH. Since
we, the citizens, have made the investment which produced this new
technology, why aren't the results considered public property to be freely
usable by 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 amuck (resulting in even the suggestion that some of our National
Parks should be sold off to entrepreneurs), advancing this argument may seem
foolhearty; 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. 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 department colloquia 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."
According to a representative of Immunex, "If you take patents away, you take
biotechnology away, and people will die." In regard to assuring new drugs
and life saving wonders, we should realize that, over the last century or so,
twice as much of the increase in life expectancy has been due to the mundane
and unglamorous work of civil engineers (drinking water systems, sewage
purification, etc.) than from doctors and the medical establishment, no less
molecular geneticists. If saving lives were truly the goal we were seeking,
this society would have put investment into reducing infant mortality instead
of developing genetic engineering; simple cost benefit analysis would show
that we would get a larger saving of life for each dollar spent. That this
issue is, at its base, essentially one of power, is illustrated by the fact
that the vast majority of the 35,000 infant deaths which occur each year in
this country occur in ghettos, barrios, and reservations to women who do not
have nearly the same power to influence Congressional investment choices as
do academic biologists and Wall Street venture capitalists.
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, by the way, 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 progressives against conservatives.
Rather, elements of both the left and the right are raising concerns about
the directions which liberal 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 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 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 Op Ed. This is one essay in an occasional series of
articles on technology policy.
|