|
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_ftn3[3] . 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:
.. and so on 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 "bio-colonialism" 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".
|
The
author can be reached at: dwivedianu@legalserviceindia.com /
