The ethics of DNA Patenting
Anurag
DwivediK austubh Anshuraj
Introduction
The study of biology was radically transformed by the discovery of
the double helical structure of DNA, which is the genetic material of
living organisms . Since
then, scientists have made considerable advances in understanding how DNA
works, and how differences in DNA lead to differences between people. But
rapid developments in biotechnology during the past decade have enabled
corporations , scientists and “bioprospectors”
to alter nature's handiwork for commercial profit. A major strategy for private
exploitation in this area is to obtain the patent rights to an organism or its
component parts. As these developments affect all of society, we need to decide
whether any corporation, institution, or individual should have the right to
private ownership of life.
It is commonly accepted that benefits that have accrued to society from the patent system
cannot be ignored, but the question remains whether the application of the
patent system to DNA sequences is achieving its goals, namely the stimulation
of innovation for the public good, and the rewarding of people for useful new
inventions.
We know that many patents that assert rights over DNA
sequences have already been granted
but are of doubtful validity. The effects of many of these patents are extensive
as well as controversial , because
inventors who assert rights over DNA sequences obtain protection on all uses of
the sequences which has generated a lot of controversy as they directly come
into conflict with many moral and ethical questions. In the light of this controversy we have attempted to examine
various aspects relating to DNA patenting .
The patent system
Before turning to the question of patents involving genes, it is
important to discuss the patent system in general.
Patents are exclusive rights granted for a
limited period of time by states through their legal systems to inventors to
prevent others from exploiting the patent holder’s invention. Patent
applications contain claims which set out the precise nature of the
protection.. Patent claims are normally drafted to ensure that they cover more
than exact duplication of the inventor’s work.
Patents can be broadly divided into three categories, though these categories are not formally
distinguished under the patent system. A product patent is a patent on
the product itself. The term ‘product’ normally means a mechanical, chemical or biological entity,
substance or composition (as distinct from a device or electrical circuit). A
patent that asserts rights over a product itself covers all uses of that
product
.
A process patent is a patent on a method or
process. This covers a process, and may also include what is directly produced
from the process. If a product is made by another process, not covered by the
patent, it does not infringe it. A use patent is a patent on the use of
the product for a specific purpose; only the specified use is covered.
An important
feature of product patents is that they extend to new uses of the invention
that may develop subsequently, even if these uses were not anticipated or
predicted by the owner of the patent.
Of the three main kinds of
patent i.e. product, process and use patents, only product patents can assert
rights over DNA sequences themselves. Use patents only extend to the use of the
sequence. In practice, use patents may also restrict access to the DNA sequence
itself.
Ethical issues relating to DNA patenting
Exciting
invention in the field of bio technology have been made in recent years
following the examples of the owners of
bio tech patents companies with high investment in the field of bio technology
now recognized the advantage of protecting and enforcing their intellectual
property rights and in relatyion to this a series of ethical questions relating
to the patent aspect has emerged. In the middle of this debate are ordinary
citizens, often uncomfortable with the
idea that something as fundamental as a gene can be patented but at the same
time eager to see new medicines.
The objection which is forwarded against genetic
patenting is that genes are "products of nature" and therefore ought to be off-limited. The
courts have recognized a "products of nature" doctrine and used it to
reject some patent applications.
However a counter-principle has also evolved : Even a product of nature can be
patented if a inventor has devised a
new process of purification or collection that makes a substance available in
previously unknown quantity or purity. Examples patented in this century
include adrenaline and purified Vitamin B1. The most well-known example of a
living organism which was granted a patent is the genetically engineered
bacterium that was the subject of litigation in America, in the case of Diamond v Chakrabarty
. By a 5-4 decision, the U.S Supreme Court allowed the grant of the patent
to stand, US Chief Justice Burger famously remarking that in principle ‘anything
under the sun that is made by man is eligible for patenting.’Other living
organisms that have been patented include yeasts, viruses, and cell lines. This
case sent a crucial signal to the world that patenting must be made available
in any country which sought to join the race for commercial returns on bio
technological research and made it easy for the courts to extend the doctrine to genes. One reason is that
isolating a gene for medical use is not simply a matter of plucking it out of
the body. The "genes" that researchers patent barely resemble genes
as they exist in nature’.
Advocates
of gene patents cite the sophistication of this work (i.e. gene patenting) in
arguing that ownership rights are not being granted to scientists simply
because they stumble on an aspect of nature, but rather because they are
deploying complex techniques to manipulate nature in the service of human
goals.
The next argument that is forwarded
against D.N.A patenting is that such patents make important products more expensive and less accessible. The
biotech industry claims that patents are necessary so that innovative,
life-saving technologies can be
developed. In actuality, patents enable companies to create a monopoly on a
product, permitting artificially high pricing. As a result, products such as
drugs are often priced out of reach for many of those who need them.
There are
3.5 billion bases in the human genome. The human genome is, in effect, a single
sentence: ccacatgatatctatccaacccatgtccccacatgatatctatccaaccatgt... and so un
it would fill 500,000 pages various
aspects of a telephone directory. Once the human genome is decoded, it will
begin to transform various aspects of human life including medicine, science,
human fertility, archaeology, genealogy, the insurance trade and the whole of
human society. Knowledge of the human genome, the code of life, will allow us
to determine exactly what it is that makes us human. The code may give us the
cure for cancer, heart disease and a thousand genetic human frailties.
Decoding
human genome will be of great benefit to human race, a cure for AIDS or maybe eventually all of the diseases that afflict humanity can be wiped off. So we
can say Genomic is the future of a whole new set of pharmaceutical industries
that will create thousands of individually tailored drugs and consequently
billions of dollars would be needed to invest in these complex researches.
Where will this money come from? Obviously from the people, who will in turn
benefit from this research. And regarding the high pricing of life saving
technologies, it is it has observed that many of the pharmaceutical companies
sell these drugs at a much lower rate than feared.
Patents
on living organisms are morally objectionable to many people. Patenting
organisms and their DNA promotes the concept that life is a commodity and the
view that living being are "gene machines" to be exploited for
profit. If it is possible to consider a modified animal an invention, are
patents and human reproductive cells and their marketing far behind? Patents
derive from concepts of individual innovation and ownership, which may be
foreign to cultures which emphasize the sharing of community resources and the
free exchange of seeds and knowledge. Many disputes involving patent infringement
cases emerged because of question related to obviousness, enablement or the
priority of invention that had to be decided by the courts. More difficult were
the questions about the ownership rights and privileges. For example, in the
patent 'Unique T-lymphocyte line and products derived therefrom', the inventors
used the spleen of a patient Mr. John Moore who suffered from hairy cell
leukemia and came for treatment to Dr. David Golde at UCLA. As part of the
treatment, his spleen was removed and Dr. Golde developed a cell line with
enriched T-lymphocytes that produced large amounts of lymphocytes useful for
cancer or AIDS treatment. Without Mr. Moore's initial knowledge or consent, but
requiring his repeated visits to the hospital, Dr. Golde and the University of
California applied for a patent on the cell line derived from Mr. Moore’s
spleen which was granted in 1984. Mr. Moore subsequently sued Dr. Golde and the
University supreme Court. Both the Appeals Court and the Supreme Court
recognized the novelty of Mr. Moore's claim Mr. Moore on the issue of
conversion (unauthorized use of his body part), but recognized his right to be
informed of what the physician was doing involving his health and well being.
It's as irony that a person is not given any benefit of the substance which he
himself had produced, and at the same time others are minting money from the
same substance.
Defenders
of such patents such as biotechnology firms, joined by some researchers in
academia and the pharmaceutical industry argue fiercely that without patents
society won't benefit from revelations about the molecular roots disease.
Moreover the arguments that patenting DNA promotes the view that life is a
commodity, cannot be accepted because it is not that the main aim of the DNA
patenting to earn profit or to use it for someone personal interest, on the
contrary the overall aim of the patent system is to promote the public interest
and to provide a fair reward to inventors. The patents system is said to be
justified because it provides an important incentive for the development or new
products and technologies related to healthcare.
One of the most coveted argument which is vociferously put forward
against the patenting of life forms is that the First World patenting of Third
World genetic resources represents theft of community of biological resources.
Patents held by the industrialized world on biological resources from the
developing world will serve as a tool for the North to accumulate more wealth
from the already impoverished south. Microorganisms, plants, animals and even
the genes of indigenous people have been patented for the production of pharmaceuticals
and other products. Requiring developing nations to pay royalties to the
wealthy industrial nations for products derived from their own natural
resources and innovation in robbery. Moreover the developing world has never
received compensation or recognition for these intellectual and technological
contributions. Patenting life forms will exacerbate this inequality. This
"biocolonialism" will continue the pattern of a few transnational
corporations profiting at the expense of genetic resources of the third world
countries.
But
biocolonist have their own defence; they argue that "Decoding the human
genome will increase our knowledge a thousand fold times a thousand fold of the
nature of Homo sapiens. And with that knowledge will come immense power. Before
we create, we will almost certainly destroy, committing a new form of human
selection, genomecide. Through systematic but simple foetel genetic tests in
the next decade, we will ruthlessly search out and eradicate those human genes
we regard as inferior, Trisonomy 21 or Down's Syndrome, Turner's Syndrome,
Huntingdon's Chorea, Cystic Fibrosis; the list is as long as we want to make
it. Certainly there will be great benefits a cure for AIDS malaria, maybe
eventually nearly all of the disease that affect humanity. Genomics is the
future of a whole new set of pharmaceutical industries that will create
thousands of individually tailored drugs.
But
the question is where to draw the line? Will one abort multi-celled fetuses
because the tests show genes that code for Alzheimer's in later life? Would we
now eradicate the former US President Ronald Reagan, whose Alzheimer's is
genetically inherited, just after conception? What is the definition of an
acceptable genetic human being? What is a valid human life?
Some legal & technical concern
The application of the patent system in the
field of biotechnology and biomedicine is justifiable as a way of striking a
reasonable balance between the right of inventors and the public interest. But
such patents involve some legal and technical issues which are as follow:
The
first concern is that patents which assert right over DNA sequences in
particular human DNA sequences, should not be allowed by virtue of the special
status or nature of DNA. While dealing with this question we have to draw an
important distinction between the acquisition of knowledge about the nature and
functions of a DNA sequence, and the information contained within that
sequence. Although we think that the judgment that isolated DNA sequences are eligible
for patenting, is based on questionable extrapolation to the case of genetic
information from the case of the isolation of chemical compounds, we accept
that a limited number of the early patents granted on that basis need not now
be called into question in view of the inventiveness required to isolate the
DNA sequences. Since the early days of the pioneering experiments using
positional cloning techniques patents have been field on many DNA sequences,
which were mass-produced by a mixture of computational and cloning techniques.
Even if it can be convincingly argued that these sequence were eligible for
patenting, the patents should be examined in the light of the criteria for
inventiveness and utility. we note that as techniques have advanced, and in
particulars as the use of computers to identify genes has become more
widespread the eligibility of DNA sequences for patenting should have
diminished.
The second concern is that patents which asserts
rights over DNA sequences should not be allowed because they do not meet the
legal criteria for patenting. With
regard to the legal criteria for assessing patents with claims to DNA
sequences, while the test of novelty can be met, the tests of inventiveness and
utility are more problematic. In the
case of inventiveness, we hold that as the use of computational databases
becomes the standard way of identifying genes, it is difficult to see how the
test can be met, despite current US practice. In the case of utility, we argue
that the standard of credibility required for a claimed utility needs to be set
higher than the mere theoretical possibility of this utility; some positive
evidence that the DNA sequence has the claimed utility should be required.
Some glaring
questions relating the Patentability of genes or nucleic acid
There is a current debate on the inherent dangers of the process of
creating transgenic organisms, which is why UK and many countries in Europe are
banning transgenic crops or imposing a moratorium.
Transgenic DNA has the potential to generate new viruses and bacteria
that cause diseases, and may also cause cancer by integrating into mammalian
cells. The transgenic DNA from terminator or GURT technologies involve even
greater risks, as they contain dangerous genes that prevent germination, which
can nonetheless escape into other species. Furthermore, the technologies depend
on gene-splicings that have to be engineered and regulated very precisely, but
those requirements are beyond the capability of the genetic engineer. The
hazards of the transgenic DNA resulting from GURT technologies are much
greater, because the imprecisions of inserting multiple gene-constructs are
multiplied, and because of the gene-splicing sequences and genes deliberately
introduced. Gene splicing has the potential to create new combinations of genes
and to scramble genes and genomes when it is imprecise.
How can we regard this as a patentable invention when
it is so hit or miss and unreliable? It is both scientifically flawed and
ethically unacceptable to create so much suffering.
The patentability of genes and other nucleic acid sequences is
justified on the ground that they have been subject to a microbiological or
nonbiological process, i.e, gene sequencing, which is itself a standard process
patentable and patented under existing patent laws for invention. So, the
actual patented entity is the nucleic acid sequence itself and its putative
function.
However, the DNA or RNA sequence is subject to change by mutation,
deletion, insertion and rearrangement. Does it mean that, for example, if the
sequence patented is, ATCCAGAACCTA, then variously mutated sequences such as
AACCAGGAACCTA (single base substitution), ATAGGAACCTA (deletion of two bases),
ATCCATCGGAACCTA (insertion of two bases), AGACCTGAACCTA (inversion of 5 bases)
are no longer covered? The confusion is multiplied when single nucleotide
polymorphisms (SNPs) are ruled to be independently patentable by the US Patent
Office. Thus, the patent for the gene and the patent for the gene variant will
legally clash.
The same arguments of mutability of entire genomes raise the question
as to which genome is being patented. If the patent is on one DNA base
sequence, does it cover genomes differing in DNA base sequence?
For a DNA sequence of 10000 bases, the possible number of variants is
410000
The “industrial application” stated in the EU Directive Article 5.1
involves the functional side of the gene sequence, and presumably qualifies it as an invention. It is important to realise, however, that the nucleic acid
molecule by itself can do nothing. It can only have a function in a living cell
or an organism. However, its function depends on which kind of cell it is in,
where in the genome it is inserted (not under the control of the human genetic
engineer), in what kind of genome and in which environment. In other words, its
function is uncertain and unpredictable. For example, the acetyl-CoA
carboxylase gene, which confers herbicide resistance in monocots, is claimed
primarily for regulating oil content in a patient. Under some circumstances,
again beyond the control of the genetic engineer, the gene is silenced, so it
has no function whatsoever. Thus, the patentability based on function is
equally unscientific.
The patenting of genomes raises the question of the function of the
genomes. Again, the isolated genome can do nothing by itself while its
‘function” in the organism cannot be considered separately from the totality of
the organism.
Conclusion
A ban on
patenting genome sequences would be both impractical and unrealistic and
tighter rules are needed on the conditions under which such patents are
granted.
As already
referred, the most commonly heard refrains from those critical of the private
sector’s control over biotechnology is that no patents should be granted on DNA
sequences because such stretches of DNA are ‘natural’, and therefore cannot
qualify as inventions (which is what the patent system was set up to protect).
On ethical grounds, an equally strong argument is made that if the human genome —
and all its contents — belongs to
anyone, it should be commonly owned by all mankind. Staking claims to the
sequences that make up individual genes, even if previously unknown is
portrayed as the ultimate form of “biopiracy”.
Unfortunately,
perhaps, such a viewpoint appears somewhat utopian. We live in a world where
society, through its patent laws, has already agreed that certain kinds of
products can be patented. A likely candidate, for example, would be a gene
sequence that forms an essential element of a novel diagnostic test for a
disease.
But that
does not mean that nothing can — or should — be done about DNA patents.
In future, a
patent should only be granted on a gene if the social benefit likely to emerge
from knowing the genetic code for that gene can be clearly defined. Patents on
gene sequences should no longer cover all possible uses of that sequence, some
of which may be unknown. In this regard it is submitted that patents must
satisfy the condition of not being contrary to morality or ‘ordre public'
and suggest that patent offices should seek general ethical guidance, as
necessary, from relevant bodies.
As the
Nuffield panel6 concludes, DNA patents should be “the exception
rather than the rule”.”
It is not
as simple as, ‘Patents, good or bad?’ or ‘Licensing, good or bad? “The mission
should be to make sure that all this research benefits people”.
Selected References:
1.
Sudip
Chaudhuri, (2002) “TRIPS agreement and Amendment
of patents Act in India, EPW Aug.10-16, 2002, Vol.XXXVII, No.2, p.3354-3360.
2.
Barton, Dellenback and Kuruk (1989) “Toward a Theory
of Technology Licensing Stanford Journal of International law 25 1989, 195-225
quoted in Lasser, W. (1991).
3.
Burstein (1984) “Diffusion of knowledge Based
products: Applications to Developing Economics, Economic Enquiry, p.612-33.
4.
Duffey (1989) Intellectual property needs of
multinationals in W. Lesser, et.al., “Equitable patent protection for the
developing world, Cornel University.
5.
Deolabhah and Evenson (1989) “Technology production
and Technology Purchase in Indian Industry: An Econometric Analysis Rev.
Economic and Statistics.
6.
Ganesan (1989) Intellectual property rights standards
and principles in Sudip Chaudhuri (1993) op.cit.
7.
Mcleland (1987) and O’Toole (1986) “Patent Systems in
Less Developed Country. The cases of India and the Andean pact Countries, The
Journal of Law and Technology, p.229-48.
8.
Sudip Chaudhuri (1993) Drunkel Draft on Drug patents
Background and implication EPW, Vol.28, No.36, Sep.4, p.1861-1865.
9.
Behrman (1980) Tropical Diseases: Responses of
Pharmaceutical companies, Washington, DC, American Enterprise Institute.
10.
Abraham (1989) Some consumer and third world concerns
on the patenting of Bio Technology products and process in W. Lesser, op.cit.,
1991.
11.
Michalet (1977) “South National Corporations and
Transfer of Technology in Dr. Germidis (ed) Transfer of Technology by
multinational corporations Paris, OECD.
12.
Nadal (1977) “Multinational Corporations and Transfer
of Technology the case of Mexico in D. Gerrmds (ed) Transfer of Technology by
multinational corporation, Paris, OECD.
13.
Nair, M.D. (2002) “Issues on TRIPS of Concern to
India, WTO, Problem of Developing Countries, The Hindu, Monday Sep,23, 2002,
p.16.
14.
Suman Sahai (1994) “Intellectual Property Rights for
Life forms What should Grounds India’s position, EPW, Vol.XXIX, No.3, Jan.15,
94, p.87-90.
15.
UNCTAD (1988) “Technology Related Politics and
Legislation in a Changing Economic and Technological Environment, New York,
United Nations.
16.
Vaistos (1974) “Inter country Income Distribution and
Transnational Enterprises, Oxford, Clarendon Press.