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The
Ethical and Legal Issues of Gene Patenting
Written by Aparajita
Tayal
[1]
Introduction
The
conflicts between science and the law are centuries old and have greatly
intensified with the rapid progress that has shaped our world into one which
relies on technology to make our lives more efficient and which promises a
better tomorrow for everyone. In the early days, science and law came into
conflict because scientific theories and the prevailing concepts of law were
immeasurably divergent. The conflict we face in this day and age is not whether
scientific postulates that are contrary to rule of law should prevail, but
whether and to what extent law, or government, should or should not influence
scientific progress
[2]
. The law is
no longer stagnant and is incessantly attempting to stay abreast with the rapid
pace of progress and development. People, in their need to keep society under
control will continue to strive towards establishing a balance between the
extremes of scientific innovation and the established rules of law.
Biotechnology has been defined
[3]
as being any technique that uses living
organisms, or parts of organisms to make or modify products, to improve plants
or animals or to develop micro-organisms for specific uses. The
biotechnology industry has come of age and has led to infinite prospects such
as tailoring treatments to people's individual genetic makeup, developing new
vaccines, preventing disease by intervening in the genome
[4]
.
The issues that may affect the biotechnology industry include inter alia discoveries in, and related
to genetics, such as the patentability of genetic information, the conduct of
clinical trials involving gene therapy, the approval process for new drugs,
proteins and other biological components, genetic testing and cloning. The
biotechnology industry has certain unique aspects that distinguish it from
other sectors, such as lengthy product development lifecycles, significant
financial resources, and complex intellectual property issues.
Although
deciphering human gene sequences is very time-consuming, the deciphering
process is advancing at a surprisingly fast rate because of cutting-edge
information technology, and especially progresses in computer technology. As a
result, information taken from the human genome (DNA information) is being
transacted as it has economic value. Western countries own the majority of this
DNA information. Patent law is being utilized for legal protection of such DNA
information. Pharmaceutical companies, then, endeavor to develop innovative drugs
using DNA information.
[5]
I.
Definition
of a Gene and Related Terms
A gene is the fundamental physical and functional
unit of heredity that is made up of tightly coiled threads or polymers of
deoxyribonucleic acid (DNA). A DNA molecule consists of two strands that wrap
around each other to resemble a twisted ladder or double helix. DNA is an
informational molecule and is made up of four distinct nucleotides which forms
the base of each DNA molecule. There are four kinds of nucleotides in the Human
body, namely- deoxyadenosine (A), deoxyguanosine (G), deoxythymidine (T), and
deoxycytidine (C). It is the “permutations and combinations” order of these
individual “bases” that result in the double helix of the DNA molecule.
However, in and of itself, DNA has no functional property. It is a chemical
that, when placed in an appropriate environment, will direct the synthesis of
particular and specific proteins, which make up the structural components of
cells, tissues and enzymes (molecules that are essential for biochemical
reactions). This environment is known as the cell. Organisms from single-celled
protozoan to far more complex human beings are made up of cells containing DNA
and associated protein molecules. The DNA is organized into structures called
chromosomes, which encode all the information necessary for building and
maintaining the organism. A DNA molecule may contain one or more genes, each of
which is a specific sequence of nucleotide bases. It is the specific sequence of
these bases that provides the exact genetic instructions that provides an
organism with its own unique traits.
The
question that arises, then, is what is gene patenting? "Gene
patenting" is a broad term referring to the patenting of either a process
that involves isolation of DNA (where DNA refers to either DNA or associated
materials such as RNA) as well as to a chemical substance related to DNA. A patent is not received on just a gene. A
patent is received on a gene, gene sequence, or gene fragment based inventions. DNA products usually
become patentable when they have been isolated, purified, or modified to
produce a unique form not found in nature. Isolated and purified genes are
patentable inventions if they meet the Patent and Trademark Office's standard
criteria, including being novel, well described and useful. Patents are granted
on "isolated" genes and gene products where the gene or gene product
has real world applicability.
[6]
The patents cover genes and gene products that could be obtained from any
person, for example from a blood sample. Gene-based patents have helped to
secure the biotechnology and pharmaceutical industry's interests in the
development of gene-based therapeutics. For example, the gene encoding
erythropoietin was cloned in 1985, which lead to the production of recombinant
EPO (Rhu-EPO). This gene was patented by Amgen in 1987
[7]
.
The protein expressed by this gene is used in the treatment of anemia arising
from several disease conditions. A 'genome', on the other hand, is the complete
set of genetic instructions carried within a single cell of an organism. A gene
is a small subunit of the genome which in general ‘codes for’ - contains the
information necessary for constructing - a single protein, or protein subunit.
The human genome is estimated to comprise more than 120,000 genes.
An EST,
or "expressed sequence tag," is a DNA sequence of several hundred
nucleotides. As the name implies, ESTs are DNAs that code for a particular
protein. ESTs are DNAs that have been transcribed and are ready to be
translated into a protein. An EST is typically obtained by determining the
sequence of several hundred nucleotides of one end of a gene. Because several
hundred nucleotides are more than sufficient to distinguish any given gene from
all other genes, an EST is a convenient means of identifying a specific gene in
the context of a single chromosome, a complete genome or a collection of genes
(often termed a "library"). ESTs have a number of immediately useful
characteristics. For example, an EST can be used as a label to map a specific
location on a chromosome. Because the sequence information contained in an EST
is enough to distinguish one gene from all others, each EST may be used to
identify the chromosomal location of its corresponding gene on a chromosome.
The ability to identify the chromosomal location of a particular gene is
important in the detection of chromosomal mutations and corresponding diseases.
Using an EST as a tool in this way may allow a doctor to diagnose a particular
genetic disease in time to provide an effective preventive treatment. ESTs may
also be used to distinguish between cell or tissue types.
A variety of tests now make it
possible to examine a person's DNA to determine the sequence of the nucleotide
bases at critical points within a particular gene. The DNA is typically
obtained from a blood sample. Certain DNA sequences have been shown to cause
disease or to confer an increased risk that a healthy person will develop a
disease later in life. Genetic tests provide physicians with information about
the DNA sequence of a particular gene for a particular person. With this
information, a physician can prescribe drugs, special monitoring or preventive
measures to treat the disease or reduce the risk that it will develop. This is
the subject of a new area of medicine called pharmacogenomics. Some people with
an inherited predisposition to a type of colon cancer owe their lives to
genetic testing. The test results prompted physicians to remove part of the
colon before it turned cancerous. Some people prefer not to have genetic tests
that may indicate a tendency to develop illness, however, especially if there
are at present no therapies to prevent or delay the condition. As medical
science advances, more genetic tests are likely to become available, and these
will likely indicate tendencies to develop diseases not normally thought of as
"genetic": diabetes, for example.
Gene therapy holds major
promise for medical science to correct genetic defects. This can be achieved by
replacing, augmenting, or eliminating absent or defective genes, as well as by
providing genes encoding therapeutic or immunogenic
[8]
proteins. Gene therapy could potentially be used to combat inherited disorders,
such as hemophilia; disorders requiring enhanced production of a protein, such
as critical limb ischemia; or acquired diseases such as cancer, cardiovascular
diseases and HIV infection. One method of gene therapy works by replacing a
patient's ineffective or absent gene with a therapeutic gene (e.g. a
replacement gene). The therapeutic gene enables the patient's cells to produce
a specific protein that prevents or fights a disease or disorder. Because the
new protein is produced in the patient's own cells, it is processed with a
precision required by the patient's body, and is recognized as
"self." Gene therapy requires delivery of the therapeutic gene into
the cell, utilizing vectors. The most effective vectors come from simple
viruses and DNA plasmids, which can effectively penetrate the cell and deliver
the therapeutic gene. As genetic research moves into the future, gene therapy
will provide researchers, and patients, with the ability to combat a wide range
of diseases and disorders.
A
patent is an agreement between the government and an inventor whereby, in
exchange for the inventor's complete disclosure of the invention, the
government gives the inventor the right to exclude others from using the
invention in certain ways. The property right provided in a patent is quite
different from what we typically think of when we own property. What is granted
is not the right to make, use, offer for sale, sell or import, but the right to
stop others from making, using, offering for sale, selling or importing the
invention. A patent grants exclusive rights to inventors for limited periods of
time.
Under
Section 101 of the U.S. Patents Act, 1957, various types of invention can be
patented. These are:
-
A process - for example, a process of making a chemical
by combining chemical X with chemical Y, or a method of treating a cancer
patient by administering a specific drug.
-
A machine - for example, a flat-screen high-definition
television set or an X-ray machine.
-
An article of manufacture - for example, a silicon
computer chip or a specially-molded piece of plastic for an automobile bumper.
-
A composition of matter - for example, a new
pharmaceutical drug or a new plastic for use in kitchen counters.
-
Any new and useful improvement to any of these
categories.
Other
types of inventions or discoveries cannot be patented; these include naturally
occurring organisms, laws of nature, natural or physical phenomena and abstract
ideas. Biotechnology inventions generally fall into one of two different
classes:
-
One class is new compositions of matter related to newly
discovered isolated genes or proteins or to pharmaceutical inventions based on
those genes or proteins. One cannot patent a naturally-occurring gene or
protein as it exists in the body, but one can patent a gene or protein that has
been isolated from the body and is useful in that form as a pharmaceutical
drug, screening assay, or other application.
-
The second class of biotechnology inventions includes
methods of treating patients with a given disease through the use of a
particular gene or protein. Even if someone has a patent on a gene or protein,
a second inventor can obtain a patent on a new use of that gene or protein, if
the second inventor discovers a new use for the substance.
In
order to obtain a gene patent, an inventor must show that these four criteria
are met:
-
The
invention must form patentable subject matter. According to the
“product of nature” theory, “any kind of structure made by a human hand” is
patentable, but things that exist in substantially the same form in nature
(that is, not made by human hand), namely “products of nature” are not
patentable.
The
position in law vis-à-vis separation using recombinant DNA technology is when
the human and material resources inserted in research reach a certain level,
the product of such research is protected under patent law. Judge Hand’s
opinion in the
case of Parke-Davis & Co. v. H.K. Mulford & Co
[9]
illustrates that patents are not denied merely because products of nature are claimed.
This suggests that if there is sufficient reason for granting a patent, then
the subject-matter requirement will be satisfied even if the subject matter
claims product of nature. It has been said that the difference between a
discovery and invention is a difference in degree rather than kind.
It was
held in the well-known case of Diamond v. Chakraborty
[10]
by the United States Supreme Court that genetically manipulated organisms are
subject matter under section 101. In light of the “product of nature” theory,
the Court’s reasoning can be comprehended, as there was no corresponding
organism to the claimed organism in nature. The Court further said in this case
that statutory subject matter includes “anything under the sun made by man”.
A
patent claim over an isolated and purified DNA molecule could cover either a
gene excised from a natural chromosome or a synthesized DNA molecule. In
response to objections received by the United States Patent and Trademark
Office regarding patentability of “isolated and purified” DNA molecules, it
said that an isolated and purified DNA molecule that has the same sequence as a
naturally occurring gene is eligible for a patent because (1) an excised gene
is eligible for a patent as a composition of matter or as an article of
manufacture because that DNA molecule does not occur in that isolated form in
nature, and (2) synthetic DNA preparations are eligible for patents because
their purified state is different from the naturally occurring compound.
[11]
The
position in the European Union Directive on the Legal Protection of
Biotechnological Inventions, 1998 is given under Article 5 and is as follows-
1.
The
human body, at the various stages of its formation and development, and the
simple discovery
[12]
of one of
its elements, including the sequence of a partial gene, cannot constitute a
patentable invention.
2. An
element isolated from the human body or otherwise produced by means of a
technical process, including the structure or partial structure of a gene, may
constitute a patentable invention, even if the structure of that element is
identical to that of a natural element.
-
The invention must be novel and
non-obvious. The invention must not have been described or discovered by
another before the inventor filed a patent application. The invention must
also not be obvious from the prior work of others. In patenting a gene or a
protein, the requirement for novelty and non-obviousness usually means that
the inventor must have newly discovered the chemical structure of the gene
or protein. If that structure already is known, the inventor cannot meet
this requirement. The requirement that the claimed subject matter be
"new" is an integral and historically constant feature of U.S.
patent law. Traditionally, courts have interpreted the requirement of
newness as excluding from patentable subject matter certain discoveries that
lack invention, such as laws of nature[13] and, most importantly for
purposes of the subject at hand, naturally occurring products, processes,
and other phenomena. The non patentability of these categories was
established under the 1952 Act as well as under its predecessors. Thus, a
plant, animal, or microbe newly found in the wild, or a mineral or chemical
newly discovered in the earth, or any part of a plant, animal, microbe,
mineral, or chemical is not patentable subject matter; such discoveries are
"manifestations of nature, free to all men and reserved exclusively to
none."[14] "Novelty," defined in section 102 is satisfied by
a showing that the claimed product or process was not previously known or
used by any other person in the United States. In addition, the invention
must not have been patented or described in a printed publication in the
United States or a foreign country, or in public use or on sale in the
United States more than one year prior to the application date. The
"non obviousness" criterion, defined in Section 103 was added to
the 1952 Act and requires that the product or process not be self- evident
to a person having ordinary skill in the relevant arts. This does not mean
that the non-obviousness requirement for a product patent may be satisfied
by the non-obvious method by which the claimed invention was discovered.
Rather, it means that the claimed invention itself would not be obvious to a
practitioner. If the invention itself is obvious, it does not matter whether
the method of discovery is non-obvious. Similarly, if the invention itself
is non-obvious, whether or not the process by which it was discovered was
well known is irrelevant. Put differently, if the patent sought is a process
patent, then the process must be non-obvious, and the non-obviousness of the
product made by the process is inconsequential. If what is sought is a
patent on a biochemical, then the molecule must be non-obvious.
-
The
invention must be useful. The inventor must show that the invention has a
real-world use. It is not enough just to find a new gene or protein. The
inventor must specify what the uses are; for example, whether the gene or
protein is useful as a drug for disease X or as a target for disease Y or as a
diagnostic marker for disease Z. In early U.S. case law, only minimum utility
was required. Prior to Brenner v. Manson
[15]
, inventions were useful if capable of some beneficial use to society. The
aforementioned case changed this view and required `substantial utility` and
`specific benefit...in currently available form`. Thus, Brenner established the view that a compound which is only useful
in research does not meet the utility requirement, even if that research could
lead to a useful product. Thus, the test of utility
refers not to commercial viability, but to the necessity that the invention be
put into practice. The United States Patent and Trademark Office
has issued utility guidelines
[16]
aimed at stopping companies from making frivolous attempts to patent genes
before they have established a particular use for them. The rules are intended
to help end a bitter debate on gene patenting. These regulations have put to
rest any question about whether genes can be patented at all -- making it clear
that companies may indeed patent both whole genes as well as pieces of genes,
though genetic sequences or ESTs are not patentable. The new guidelines have
placed a more stringent utility requirement. To demonstrate utility as that term
is now interpreted by the Patent and Trademark Office of the United States, the
applicant must show a specific, substantial, and credible use for the claimed
invention. This may curb many companies from racing to
file a patent immediately after isolating the DNA or gene as a specific and
substantial use must also accompany the application.
-
In addition to these three requirements, the application must describe the invention
in sufficient detail to inform the public on how to make and use the
invention. The inventor must teach or "enable" other persons skilled
in the technological area of the invention to use the invention described by
the inventor. This is known as the `enablement` requirement.
II
Public Policy and
Gene Patenting
This
part of the paper will address whether policy considerations justify the
current trend of granting patents on genes and other subject-matter covered
under the broad ambit of genetic information. Modern biotechnology offers
unprecedented opportunities for developing medicines to treat and cure
currently intractable diseases. It relies in large part on using gene-based
inventions to make these medicines because it is either impossible or
uneconomical to make them in other ways. Patents on gene-based inventions
protect the inventions from misappropriation by commercial entities and allow a
company to have confidence that it will be able to service a viable market if
its development efforts succeed. Without patents on gene-based inventions, the
rate of medical innovation coming from biotechnology would therefore slow
dramatically.
The
analysis centers on three broad policy issues. First, the economic consequences
of the current and proposed rules governing patents on superficially modified,
naturally occurring biochemicals are analyzed. Second, the effects of such
patents on concepts of human dignity are discussed. Third, the question of how
such patents conflict with the notion of natural products as the universal
heritage of humankind is addressed.
The
purpose of patent law is the encouragement of invention, thereby securing for
the public the benefits of scientific creativity and research. Most
commentators
[17]
base the
necessity of patent protection of biotechnology discoveries on the theory that
research and public disclosure of biotechnological innovations will slow or
halt unless discovered biochemicals are patentable. Other commentators have
cautioned that issuing patents on basic research information, such as newly
discovered biochemicals, threatens to stifle research by imposing barriers for
universities, nonprofit research institutions, government agencies, and
biotechnology companies to accessing material that was invented or innovated by
no person, but patented by the first discoverer
[18]
.
There has been no conclusive empirical study to support one or the other
viewpoint. However, an analysis of the economic factors implicated by patents
on discovered or superficially altered biochemicals suggests that such patents
may impede both upstream innovation (such as naturally occurring DNA molecules
and proteins which form basic biotechnology research tools) and downstream
innovation (such as consumable products--such as pharmaceuticals, medical
therapies, and diagnostic tests) in the biotechnology and pharmaceutical
sectors. There are three possible sources of discouragement for downstream
innovation caused by the patenting of basic upstream biochemical research
tools. The first source of discouragement is the diversion of downstream
research funds into precedent research on a vast multitude of patented natural
biochemicals, the negotiation of patent licenses, and the payment of license
fees for permission to use the biochemicals in downstream research. The second
source, related to the first, is the diversion of upstream and downstream
research funds into litigation over conflicting and overlapping biochemical
patents in a field where sharp lines often cannot be drawn among patentable
products. The third source of discouragement is the delay in patent application
processing caused by the multitude of patent applications for naturally
occurring biochemicals, and lastly is the alternatives to the monetary reward
theory.
[19]
(1) The most widely discussed deterrent to
biotechnological innovation is the sometimes prohibitively high costs incurred
by persons who require the use of a patented, naturally occurring DNA molecule,
protein, or organic tissue to conduct scientific research. Patents on basic,
naturally occurring biochemicals (regardless of whether "isolated and purified"
or otherwise insubstantially altered) can hinder the development of downstream
consumable products--such as pharmaceuticals, medical therapies, and diagnostic
tests--by imposing costs that impede research that relies on access to the
patented biochemicals. This is problematic to the extent that access to the
biochemicals that comprise living organisms promotes research in diverse areas
of medicine and biotechnology. Because most scientific research and product
development relies on many prior discoveries, and most biotechnological
research involves complicated interactions among many genes and proteins, it
often has been observed that the transaction costs to obtain licenses, and the
royalties payable under those licenses, can multiply quickly in a regime where
many basic natural products are owned by private parties. This system imposes
disincentives to downstream innovation because multiple licenses on multiple
genes and gene fragments must be researched, negotiated, and paid up
[20]
,
creating costs and delays. One industry representative noted the high rate at
which royalties for patents on the building blocks of pharmaceutical products
were stacking up
[21]
. Similar
concerns relating to patent stacking have been voiced by many other
geneticists, physicians, nonprofit institutions, and biotechnology companies.
When biotechnology researchers innovate in spite of the high costs associated
with the issuance of patents on discovered phenomena, these costs may
ultimately be borne by consumers in the form of higher prices and,
consequently, decreased accessibility of products. There are also cases in
which hospitals that have tested patients for cystic fibrosis have been
required to pay royalties to a private company holding a patent on a gene
involved in the disease. Some laboratories have decided to cease using an
important prenatal test for Down's Syndrome because the royalty fees charged by
the patentee of the relevant Trisomy 21 gene exceed the authorized Medical aid reimbursement
[22]
.
The University of Pennsylvania has curtailed much of its genetic research from
fear of patent infringement, and at least one Yale University researcher has
been forced to withdraw from breast cancer research to avoid infringing license
limitations on the BRCA1 and BRCA2 genes patented by Myriad
[23]
.
While evidence on this point is far from comprehensive or systematically
measured, it does indicate at least significant professional concern with
system overload, and some of the outcomes of the current approach of the patent
system, which allows private monopolization of crucial, basic research. For
this reason, the leaders of two major German science organizations warned in
July 2000 that broad patent rights on DNA sequences "could stifle basic
genomics research and competition for pharmaceutical innovations." The greatest practical potential of gene
research is not in the discovery of the DNA sequences, but in the new
diagnostic and therapeutic technologies based upon those sequences and their
corresponding proteins. To control the sequence, however, is to control all
derivatives of the sequence, including proteins that have potential therapeutic
application and knowledge of the medical effects of mutations on the genes. A
patent on a composition of matter, such as a DNA molecule, confers exclusive
rights to the composition even if the discoverer knew of and disclosed only a
single use of the composition. Accordingly, in spite of its stance favoring the
patenting of genes and gene fragments, National Institute of Health in the
United States has recognized that allowing broad claims on genetic material
creates a de facto "unacceptable
monopoly on all fields in which the new gene might be found to be of use."
Similarly, the National Academy of Sciences has voiced its concerns that
"granting broad patents on genes, and even fragments of genes, might
seriously impede the research and development that will be necessary to realize
the promise of the human genome sequence in generating significant new
treatments and cures for human disease."
The impact
of multiple "tollbooths"
[24]
on downstream innovation, market availability, and costs can be profound. Each
tollbooth imposes potentially high bargaining costs and license fees for the
use of a basic element of research. There is an increased incentive to discover
and patent basic knowledge in order to extract licensing fees from those who
would benefit from using the biochemicals to conduct downstream scientific
research. Thus, patents on naturally occurring biochemicals may cause costs to
accumulate to the point where scientifically valuable research becomes
infeasible for researchers or inaccessible to large portions of the public
because of the large costs involved.
(2)
Costs
imposed by conflicting and blocking patents
[25]
A
related deterrent to biotechnological innovation, also caused by patents on
"isolated and purified" naturally occurring biochemicals, stems from
overlapping patents given on a single "invention." Under the current
system of allowing patents to issue on the basic building blocks of nature,
multiple patentable sequences (ESTs, codons etc.) can originate in the same
gene, resulting in upstream patentees owning rights to different parts of the
same gene
[26]
. Any
upstream researcher wishing to use that gene or a significant portion of the
gene faces a potentially vexing web of blocking patent rights, and accompanying
license negotiations, with an increased likelihood of patent litigation. A
patent on a large DNA sequence that contains a gene does not preclude a patent
on the gene. In addition, DNA fragments, such as ESTs that are part of the same
gene may be patented. The issue here is not merely patent stacking (i.e., the
need to negotiate and pay up multiple licenses to conduct research), but
overlapping patents, resulting in confusion about legal rights and costly
litigation
[27]
. The
superabundance of biotechnology patent litigation over the last twenty years
amply demonstrates this point
[28]
.
And the potential becomes ever greater as the thicket of patents grows denser.
For example, more than one hundred patents have been issued "with the term
'adrenergic receptor' in the claim language. Biotechnology firms may spend
millions of dollars clarifying and defending their claims to patented gene
sequences
[29]
.
(3)
Patent processing costs.
Another
cost of issuing patents on insubstantial modified, naturally occurring
phenomena is the increased processing time for each biotechnology patent
application. During much of this time, the contents of the patent application
remain outside the public domain, and, therefore, the public is deprived of the
benefit of that knowledge. Many of these applications do not claim minor
modifications of naturally occurring biochemicals, but, instead, claim
inventions evidencing notable ingenuity. The public is equally deprived of the benefit of these inventions while
claims on isolated and purified DNA molecules are processed
[30]
.
Moreover, various research and development activities could be carried out
unawares in the meantime to develop the same substance for which a patent is
being claimed by another company.
(4)
Reward
theory
Under a
simplified reward theory argument, discoveries resulting from upstream
biochemical research merit patents because without such patents this kind of
research would occur in minimum amounts. The typical argument is as follows.
The patent is a necessary motivator for the additional expense, labor, and risk
of basic biotechnological research necessary to achieve the optimal level.
Without such patents, the rewards for inventions based on these naturally occurring
phenomena will often be too remote and risky to justify the expense of
discovering the naturally occurring molecules. The deficiency of research into
naturally occurring biochemicals, according to this objection, will inevitably
result in decreased development of consumer products because the natural
molecules will remain undiscovered.
The
criticism for this theory is that one, the market power conferred by patents on
naturally occurring genes, gene fragments, proteins, and other biochemicals
often vastly exceeds the ingenuity required to identify the biochemicals. Such
disproportion not only discourages downstream research; it discredits the
patent system by randomly distributing market power based upon criteria that do
not fulfill the policy purposes behind the patent system. The second criticism
is that the simplified reward theory relies on the assumption that researchers
will not have adequate incentive to engage in upstream research without such
patents. This assumption manifests itself first in the supposition that
biotechnology companies will lack adequate incentive to engage in upstream
research using other forms of legal protection. It is undermined by the fact
that declaring isolated and purified, naturally occurring substances
unpatentable does not foreclose all reward to biotechnology companies for
upstream research. Biotechnology innovators retain the ability to obtain at
least some protection over their discoveries under state trade secret law.
Trade secrets carry several advantages over patent law. First, a trade secret
confers a monopoly as long as the secret is kept and not independently
discovered by another researcher, while a patent lasts twenty years. This gives
a trade secret the possibility of conferring a longer monopoly than a patent
offers if, for whatever reason, the secret is not independently discovered by
another researcher. Second, trade secrets may create a greater incentive to
disclose easily discovered research results, as independent discovery of an
invention is allowed under trade secret law, whereas independent discovery of a
patented invention is deemed infringement. Third, unlike registering a patent,
maintaining a trade secret limits the risk of fostering piracy and unlicensed
foreign duplication because there is no requirement to reveal publicly the best
mode of practicing the secret, while the best mode of practicing a patented
invention must be published for public benefit. Finally, trade secrets require
no expensive or time-consuming registration process that burdens both the
applicant and the government. Of course, trade secret law does not protect an
innovator from the discovery of the secret by others through independent
research or reverse engineering of the product, and this limitation decreases
the value of the secret accordingly.
Another
alternative means of the reward theory is patenting the invented process that
is unrelated to the patentability of the starting or ending products. In the
realm of biotechnology, a process might include a specific means of using DNA
to create a protein or a particular process for identifying the purpose of
certain DNA sequences. While such
patents do not offer as much reward for discoveries as product patents, they
offer some compensation for ingenuity that is often neglected by patent
applicants due to the preferability of broad product patent rights
[31]
.
To summarize, the option of protecting discoveries as trade secrets and
licensing them to downstream researchers remains open, as does the possibility
of patenting the process of arriving at a gene or protein. As these legal tools
have produced enormous profits for many companies in the past, it is premature
to assume that biotechnology research companies would evaporate if they could
not patent newly discovered DNA sequences or proteins. Moreover, historically,
the scientific community has considered research into natural phenomena and
publication of research findings to be the sine
qua non of a successful academic career. It has been difficult for
scientists to obtain tenure in a university without making a significant
contribution to the public knowledge about a natural phenomenon, and the
publication of basic research by academic scientists is common.
The
threat to human dignity because of gene patenting originates not in the
admittedly implausible scenario of a patent conferring complete ownership on a
human being in toto, but in the narrower ability of the patentee of an isolated
and purified biochemical or tissue found in the human body to preclude any
individual who produces that biochemical or tissue (1) from commercializing it
(or choosing not to commercialize it), and (2) possibly from transmitting the
cells to third parties for noncommercial purposes. The problem of monopolization
of naturally occurring human tissues presented itself most starkly in the
much-discussed case Moore v. Regents of the University of California.
[32]
This case held that a biotechnology firm that harvested cells from a hospital
patient for commercial use without the patient's consent could resist a legal
challenge to its right to patent the patient's cell line
[33]
.
The necessary corollary of the holding is that the patient, Moore, was
precluded from commercializing his cell line or preventing the patentee and any
licensees from doing so, or donating his cell line to a less mercenary
biotechnological use. The analysis leads to another disturbing conclusion.
Under the Moore majority's reasoning, a patient whose cells have been patented
would be prohibited from donating or selling any patented part of his
biochemical self, such as his plasma, blood, or sperm, to other scientists
without first obtaining a license from the patentee, as these other scientists
would be obtaining from Moore his cells in their patented form. The patentee
could also theoretically prohibit Moore from undergoing a leukemia test with a
group of physicians not approved by the patentee because, again, an isolated
and purified version of Moore's genome would be transmitted to a third party without
a license
[34]
. These
limitations on the rights of individuals to transfer, donate, or control
commercialization of their genetic material and, possibly, to seek some kinds
of medical care, clash with the constitutional right to privacy.
The
view that a cell line patent does not confer ownership of the genetic material
contained in that cell line is intended to soothe concerns over infringements
on human dignity, but overlooks several important facts. Most obviously, cell
lines are ultimately valuable for their genetic content, and to claim that the
government did not own the genetic material of the individuals from whom a cell
line derives is incorrect. The widespread international antipathy generated by
National Institute of Health and Department of Commerce patents attests to a
prevalent popular belief that ownership of another person's genetic material
invades that person's privacy; violates his or her bodily integrity, often for
purposes of economic exploitation; and offends his or her human dignity.
Another
issue inextricably linked with human dignity and gene patents is that of
genetic discrimination. Although genetic tests provide valuable, and often
life-saving medical information, some people fear that if the result of a
genetic test indicates that they either have a genetic disease or have an
increased risk of developing a disease, employers, insurance carriers
[35]
,
schools and others may discriminate against them. This is one reason some
people prefer not to take tests that may indicate they could develop a serious
disease in the future, especially if there are at present no effective
preventive measures or treatments. Some 24 states have enacted
anti-discrimination legislation that addresses the use of genetic information
by particular institutions. The Biotechnology Industry Organization has long
advocated legal protections to prevent genetic discrimination against
individuals.
The Universal
Declaration on the Human Genome and Human Rights was adopted unanimously by the
General Conference of UNESCO at its 29th session on November 11, 1997. It is
the first universal instrument in the field of biology. The uncontested merit
of this text resides in the balance it strikes between safeguarding respect for
human rights and fundamental freedoms and the need to ensure freedom of
research. The Declaration states that no one shall be subjected to
discrimination based on genetic characteristics that is intended to infringe or
has the effect of infringing human rights, fundamental freedoms and human
dignity
[36]
.
There
are other issues linked with human dignity, among them is the issue of cloning
[37]
.
The ethical concerns about human clones involve the risks and uncertainties
associated with the current state of cloning technology. This technology has
not yet been tested with human subjects, and scientists cannot rule out the
possibility of mutation or other biological damage
[38]
.
There exist numerous controversial issues involved with human cloning such as
the possibility of deformed offspring, designer babies and the rights and legal
protection for cloned humans. However, on the other hand there exist concerns
in certain scientific communities that the extent of legislation against human
cloning might result in stifling research into human embryology that could lead
to new treatments for disease. The potential benefits include the use of
cloning by infertile couples wanting to create a genetically related child,
those wishing to clone a lost loved one and creating tissues and organs for
transplantation.
[39]
Scores
of eminent scientists and many foreign governments have taken the position that
the human genome and other naturally occurring genomes are res communis--the common heritage and inheritance of mankind--and,
therefore, should not be subject to patents. In this perspective, because genes
are inherited from previous generations, "not invented by scientists or
corporations," patenting them is a "profound misuse of the patent
system and represents the privatization of the common heritage of all humankind."
[40]
For example, the French Minister of Science, in 1991, rejected the notion of
gene patents in absolute terms: "A patent should not be granted for
something that is part of our universal heritage." UNESCO itself has
adopted the principle that the "human genome underlies the fundamental
unity of all members of the human family, as well as the recognition of their
inherent dignity and diversity. In a symbolic sense, it is the heritage of
humanity." The gene map "should be available for all to use" with
"equal and free access." Many others have expressed similar views on
the public ownership of the genome. The opponents of gene patents on this
ground are varied but share a conception of naturally occurring genes, and the
human genome in particular, as something larger than personal property.
Moreover,
an invention must be distinguished from a discovery. A discovery relates to new
information and knowledge which already exists in nature. Invention on the
other hand relates to the creation of new products or processes which never
existed before
[41]
.
Conclusion
It
is not disputed that patenting is necessary in this field because the costs of
research and development need to be recuperated, and further an incentive must
be provided for research. However, what is argued is that patents should be
granted very cautiously and only to those genes which have been substantially transformed, or to gene
based chemicals and pharmaceuticals. The Utility Examination Guidelines issued
by the Patent and Trademark Office in 2001 permit patents to be granted on
isolated or purified genes, which are capable of performing an immediate
function. Consequently, the guidelines support the
grant of patents on a gene which in its isolated and purified form is nothing
more than a tool for scientific discovery.
On the
whole, a scheme that permits patents over such slight improvements promises to
drown out incentives to improvement with massive patent research, litigation,
and bargaining costs. It is this proliferation of potential licensing and
litigation problems that has caused some biotechnology firms to disfavor the
patenting of naturally occurring DNA, even as they are forced to engage in such
patenting in order to maintain parity with their competitors. This problem
could be ameliorated by use of the substantial transformation test. Under the
test, the basic building blocks of nature would become publicly available for
use in innovations, such as diagnostic tests and therapies. They would be
available to those who discover or learn about them through independent
investigation, trade secret license, or by passing into the public domain. By
freeing up the basic tools required for biotechnological innovation, the
substantial transformation test would simultaneously decrease tollbooth
charges, overlap in claimed subject matter, and PTO patent processing delays.
Moreover, the substantial transformation test resolves the opposition to
patenting on grounds of human dignity. By requiring that products of nature,
such as naturally occurring
human DNA, be substantially and functionally transformed by the patentee
[42]
,
the test preempts the private ownership of any person's DNA, thereby precluding
the patent system's involvement in offending any person's privacy or dignity in
this manner. Moreover, because the substantial transformation test requires any
claimed biochemical to be a product of human ingenuity, with a function or
character that is meaningfully different from the function or character of the
biochemical in nature, it cannot be argued that such inventions cover any
essential aspect of humanity. The substantial transformation test does not
foreclose the rewards for upstream biotechnology research; it merely forecloses
rewards for claims that fall outside of the purpose and intent of the patent
law.
Position with respect to India
Despite
the advantages of the biotechnology revolution, serious issues and concerns are
raised which are legal, ethical, social, moral, economic, and sociological.
With regards to India, there exist a large number of issues that need to be
dealt with. The critical success factor for a vibrant biotechnology industry is
providing financial infrastructure to support the research and development
activities of companies. There is a need to be educated in the markets and the
technologies and also develop a clear understanding of the importance of
intellectual property protection in biotechnology. There have been no clear
policies on the patenting of genes, and DNA sequences in India, even though
Indian inventors working in these areas have been applying for patents in India
and abroad.
Currently,
the manufacture, import and storage of genetically modified organisms in India
is regulated by the Manufacture, Use, Import, Export and Storage of Hazardous
Micro-organisms/Genetically Modified Organisms or Cell Rules, 1989. These Rules
are made under delegated powers given by the Environment Protection Act. The
rules are framed by the Ministry of Environment and Forests with the objective
of protecting the environment, nature and health during the various
applications of gene technology and micro-organisms
[43]
.
The
biotechnology industry in India has suffered from the inconsistent scope of
legal protection available for biotechnology inventions and there is lack of a
regulatory framework in this sector. India needs to prepare to meet the
opportunities and challenges by thoroughly debating the ethical issues.
Stringent laws need to be framed to meet the needs of the biotechnology
industry as well as society. The
Government has been encouraging in this regard, by taking appropriate steps to
provide for biotechnology patents. This is reflected in the Government’s
decision to sign the Budapest Treaty on Micro-organisms on July 20, 2001,which
will give the country the advantage of depositing patentable micro-organisms
for protection. The establishment of an international depositary in India will
help facilitate the patenting of micro-organisms that are new and are created
using inventive steps. Sensible regulatory requirements
[44]
and expeditious product review by regulatory agencies, can lead to new
applications, products, and processes that will improve human health and
welfare, enhance environmental and agricultural quality, strengthen the Indian
economy and usher in the biotechnology revolution while at the same time
protecting the ethical issues involved.
Bibliography
1. Akimitsu Hirai, Biotechnology and Legal Protection-Current
Issues, CASRIP Newsletter, Vol.8, Issue 1, Autumn 2000.
2. Li Westerlund, Biotech Patents- Equivalency and Exclusions under European and US
Patent Law, 1st Ed., Kluwer Law International, 2002.
3. The Business of
Biotech: Legal Issues in the Rush to Market.
http://www.law.com/dc/legalbus/roundtables/biotech/biotech.shtml
4. Donald
S. Chisum, Chisum on Patents, Vol.5,
(2001).
5.
P.Narayanan, Intellectual Property Law, 2nd Ed., Eastern Law House, 2000
6.
Dorothy Nelkin & Lori Andrews, Homo Economicus: Commercialization of Body Tissue in the Age of
Biotechnology, Hastings Center Rep., Sept.-Oct. 1998.
7.
Eliot Marshall, Snipping
Away at Genome Patenting, 277 Science 1752, 1753 (1997)
[1] Vth year
student, National Law Institute University
Law Versus Science: The HGP,
http://www.bae.ncsu.edu/bae/research/blanchard/www/465/textbook/otherprojects/
biotech/law.html.
[3]
Li
Westerlund, Biotech Patents- Equivalency
and Exclusions under European and US Patent Law, 1st Ed., Kluwer
Law International, 2002.
The Business of Biotech: Legal Issues
in the Rush to Market,
http://www.law.com/dc/legalbus/roundtables/biotech/biotech.shtml.
[5]
Akimitsu
Hirai, Biotechnology and Legal
Protection-Current Issues, CASRIP Newsletter, Vol.8, Issue 1, Autumn 2000.
For instance, a gene was discovered that makes a
protein [keratinocyte growth factor 2] that in natural circumstances heals
injuries to the skin and mucosal tissues. When the gene was found its entire
structure was determined; and was used to make an active protein. That protein
was able to stimulate growth of skin cells in culture; and was capable of
repairing a wide variety of skin wounds in animals and a wide variety of
injuries to the mucosal tissues in animals. The patent then describes a gene,
the protein, its activities and a series of uses.
Amgen Inc.
v. Chugai Pharmaceutical Co. Ltd. 927
F.2d 1200 (Fed. Cir. 1991)
[8]
An
immunogenic protein would not eliminate the genetic defect, but would instead
provide a protein that would make the body counter, restrain or stall the
defect.
196 f.496,116 C.C.A. 262 (1912)
447 U.S. 303 , 100 S.Ct.2204.
[11]
See Utility Examination Guidelines, Patent and
Trademark Office, 66 Fed. Reg. 1092, 1098-99 (Jan. 5, 2001) Part I- Discussion
of Public Comments.
To interpret the term `simple discovery`, the
`product of nature` theory is useful.
See Parker v. Flook, 437 U.S. 584 (1978); Gottschalk v. Benson, 409 U.S. 63 (1972); Funk
Bros. Seed Co. v. Kalo Inoculant Co.,
333 U.S. 127 (1948); 1 Donald S. Chisum, Chisum
on Patents §1.02 (2001).
Diamond v. Chakrabarty, 447 U.S. 303, 309
(1980)
See Utility Examination Guidelines, Patent
and Trademark Office, 66 Fed. Reg. 1092, 1098-99 (Jan. 5, 2001). This revision
supersedes the Revised Interim Utility Examination Guidelines that were published
at 64 FR 71440. (Dec. 21, 1999)
See,
e.g., July 2000 Judiciary Comm. Hearings, (testimony of Q. Todd Dickinson,
Under Secretary of Commerce for Intellectual Property and Director of the U.S.
Patent & Trademark Office) Some points include-
-
Without the funding
and incentives that are provided by the patent system, research into the basis
of genetic diseases and the development of tools for the diagnosis and
treatment of such diseases would be significantly curtailed.
-
few companies are
likely to risk millions of dollars in development costs on a gene product they
may not be able to patent.. Virtually cost-free to the public, making patents
slightly easier to get will satisfy the policy needs of the biotechnology
industry and will be logically defensible.
-
Without the
incentive of patents, there would be less investment in DNA research, and
scientists might not disclose their new DNA products to the public. Without
some form of intellectual property protection, pharmaceutical companies would
not bet large sums on developing gene-based drugs, and those drugs would never
reach the market.
-
In the absence of
patents, scientists might not expend the effort needed to make new discoveries
about molecular biology.
See, e.g., Working Group on Research Tools, Nat'l
Insts. of Health, Report of the NIH Working Group on Research Tools (1998),
available at http:// www.nih.gov/news/researchtools/index.htm; Eisenberg,
Technology Transfer, supra note 108, at 166;
Michael A. Heller
& Rebecca S. Eisenberg, Can Patents Deter Innovation? The Anticommons in
Biomedical Research, 280 Science 698 (1998).
Each of these actual or potential problems,
although may be ameliorated or resolved by application of the substantial
transformation test.
See John H. Barton, Reforming the Patent System,
287 Science 1933, 1933 (2000).
Eliot Marshall, Snipping Away at Genome
Patenting, 277 Science 1752, 1753 (1997).
See Dorothy Nelkin & Lori Andrews, Homo
Economicus: Commercialization of Body Tissue in the Age of Biotechnology,
Hastings Center Rep., Sept.-Oct. 1998, at 30, 37
See Kimberly Blanton, Corporate Takeover
Exploiting the U.S. Patent System, Boston Globe, Feb. 24, 2002, at 10
(Magazine)
This means that a fee or toll must be paid to use
the technology.
Conflicting patents arise when two or more
patents that cover overlapping subject matter are issued. Blocking patents are
senior patents that preempt the patentability of junior innovations because of
overlapping subject matter. For purposes of this Article, the differences between
the two are more theoretical than consequential and the terms will, therefore,
be used interchangeably.
For example, the PTO has issued patents on two
versions of the BRCA1 gene. OncorMed holds U.S. Patent 5,654,155--which covers
the normal form of the gene--and Myriad holds U.S. Patent 5,693,473--which
covers 47 harmful mutations
As one
biotechnology company executive stated with respect to research obstacles to
genetic research: "What if the gene turns out to be linked to another gene
that the French have licensed? . . . . I'm not going to invest a million
dollars with that kind of uncertainty."
Numerous examples of this litigation over the
past two decades could be cited, but a small sample of that number will suffice
here to show the overwhelming prevalence of litigation over biotechnology
patents. See, e.g., Amgen Wins Round in Dispute over Epogen Anemia Drug, L.A.
Times, July 22, 2000, at C2; Terence Chea, Md.'s Gene Logic Settles
Patent-Infringement Lawsuit, Wash. Post, Jan. 12, 2001, at E5; Denise Gellene,
Amgen Wins Epogen Patent Suit in U.K., L.A. Times, Apr. 12, 2001, at C2;
When a patent is contested in the United States,
legal defenses amount, on average, to $1.6 million. Amgen's legal costs in its
litigation with Genetics Institute over the EPO patent were reportedly upwards
of $10 million-- some ten percent of the costs of research for EPO.
Before March 2001, the patent application remained
unpublished while the patent was under administrative consideration, which
could take seve | | |