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 the
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 http://www.youthfarm.net/tag/ip-lawyers/ 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 lifeblood of
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 of 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 farms. 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
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 rime 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
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
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
Examples of Broad Patent Claims
Patent Holder (Patent Number): Claim
W.R. Grace & Co. (US5, 159, 135): Species-wide patent on all
W.R. Grace & Co. (EPO 0301749): Species-wide patent on all
W.R. Grace & Co. (application for U.S. patent): Species-wide
patent on all transgenic soybeans.
Calgene, Inc. (US5, 188, 958): Brassica transformation
patent--covering any plant in the Brassica family (rapeseed, broccoli,
cauliflower, cabbage and brussels sprouts) engineered using the
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 California (US 5,234,834): All
plants engineered to express super sweet thaumatin genes.
Hope Shand is research director of the Rural Advancement Foundation