1

INTRODUCTION:-

The rapid development of biotechnology has created significant challenges in many areas
of law. In particular, patent law has been directly affected by advances in biotechnology. The Supreme
Court’s 1980 landmark decision in Diamond v. Chakrabarty,1 holding that a patent could be obtained for a
genetically engineered microorganism2 helped to spark the biotechnology revolution. While the decision set
forth the framework for determining whether an organism is patentable subject matter, it did not resolve all
the issues associated with patenting organisms. Rather, it created the opportunity for further legal challenge
to continue to arise with advances in biotechnology permitting scientists to manipulate organisms and their
genetic code in novel ways.

One such advance is reproductive cloning, the ability to reproduce an organism from
somatic (non-reproductive) cells without sexual reproduction. In 1996, Dolly, the sheep, made headlines as
the first mammal successfully generated by cloning.3 Since then, numerous other animals have been cloned
including mice, goats, mules, horses, and cats as well as endangered species such as the gaur. 4 And now the
scientists are very much involved in producing a human clone, which has raised many ethical and legal
issues which are to be answered in the days to come. This paper focuses on the debatable issue: whether we
should accept the techniques of human cloning as patentable subject matter or not?

DEFINITION AND EMBODIMENTS OF CLONING:-

A clone is a cell or individual that has been created from, and is genetically identical to,
another cell or individual. Currently, there are three known methods for creating clones:

(1) Somatic cell nuclear transfer (“SCNT”)

(2) The creation of cell lines
(3) Embryo twinning.

While SCNT occurs only in the laboratory, the latter two types of cloning may either take
place naturally or be artificially induced.

Contrary to popular perception, cloning is not a new process, even for humans. Many
primitive organisms, such as bacteria, replicate primarily through cloning, and have done so for billions of
years. Moreover, some invertebrates, such as earthworms, retain the ability to reproduce by cloning
throughout their adult lives. Regarding humans, cloning occurs naturally with the fortuitous creation of
identical twins and, in the less fortunate, with the development of cancer.

Applications of Human Cloning

There are two theorized human applications for cloning technology:

(1) The cloning of human cells or tissues for therapeutic purposes (“therapeutic cloning”), and
(2) The cloning of a human individual for reproductive purposes (“replicative cloning”).

1
447 U.S. 303 (1980).

2
Id. At 318.

3
Ian Wilmut et al., Viable Offspring Derived from Fetal and Adult Mammalian Cells, 385 NATURE, Feb. 27, 1997, at 810.

4
See, e.g., Robert P. Lanza et al., Cloning Noah’s Ark, SCI. AM., Nov. 2000, at 84; Joseph P. Martino, Cloning of Animals and
Human Beings (2004) (unpublished manuscript), http://www.prolife technology. org/proceedings/2004/paper/2004-martino.pdf.
 2

Practically speaking, both procedures would presumably begin with SCNT. In the case of
therapeutic cloning, the nucleated ovum after fusion would be genetically modified or specially treated with
cell stimulating/repressing factors to stop development into a human being, and guide its differentiation into
a particular cell or tissue type. This process would take place entirely within the laboratory. Although this
procedure has not yet been applied to humans and is far from perfected, preliminary research suggests that
guided differentiation may be possible in the future. In the case of replicative cloning, after SCNT has been
performed, the nucleated ovum would be inserted into a human uterus (at the proper phase of the menstrual
cycle) in a procedure similar to that used with In-Vitro Fertilization. A nine-month gestation period would
ensue, followed by the birth of a human baby that is genetically identical to the person who provided the
donor nucleus.

The application of both therapeutic and replicative cloning to humans would provide
significant medical breakthroughs.

a) Therapeutic Cloning5

The utility provided by therapeutic cloning is unquestionable: through the creation of a

potentially unlimited supply of genetically predetermined tissues, therapeutic cloning is poised to erase the
two major constraints to the field of organ and tissue transplantation. First, transplantation is currently
severely limited by the inadequate supply of donor organs. Second, the immunosuppressive therapy
necessary to prevent the rejection of non-genetically identical organs is expensive and often accompanied by
severe and lifestyle -limiting side effects. By providing a mechanism for the creation of genetically identical
organs virtually on demand, therapeutic cloning could solve both of these problems. This ready supply of
organs may even foster the development of new transplant techniques to address previously untreated forms
of organ and cellular failure such as neural transplants to treat paralysis, Parkinson’s Disease, or
Alzheimer’s Disease, or even T-helper cell transplants to treat Acquired Immuno-Deficiency Syndrome
(“AIDS”). However, while cloning appears to be particularly well suited for these tasks, it is by no means
the only possible solution.

b) Replicative Cloning6

Replicative cloning also represents a tremendous breakthrough in medical science. The

procedure provides the first and only known method for both:

(1) Asexual human reproduction; and

(2) The reproduction of an individual who is genetically identical to one already born. With
current technology or the lack thereof, humans can only reproduce sexually (through the
fertilization of an ovum with a single sperm). In addition, genetically identical individuals
can only arise through embryo splitting. While this may either occur naturally, as in the
case of twins, or artificially, as may accompany in vitro fertilization, embryo splitting is no
longer possible after the second week of embryonic development. By providing a means
for human asexual reproduction, replicative cloning would allow those who otherwise
could not reproduce (without donated sperm or ova) to have children. This category would
include single - would-be parents and couples where one partner is either infertile or
possesses a genetic trait that the couple does not wish the risk of passing on. In addition,
by providing a method for the reproduction of genetically identical individuals, replicative
cloning allows for the birth of children with a specific and known bundle of genetic traits.

5
John A Robertson; “Two Models of Human Cloning”, Hofstra Law Review, Vol 27, No.3, Spring 1999.

6
Ibid.
 3

EVOLUTION OF CLONING:-

The modern age of animal cloning began in the late 1960’s when Dr. John Gurdon cloned
frogs through the SCNT of tadpole nuclei into frog egg cells. Since then, mice, cows, sheep and pigs have
been cloned through the techniques of embryo splitting, SCNT from embryonic donors, and SCNT from
adult donors. Regarding primates, rhesus monkeys have been successfully cloned through embryo splitting
and SCNT from an embryonic donor. However, these cloning have not proceeded without difficulty or
complications. To begin with, the survival rate for clones has been shockingly low. For example, Dolly was
the only lamb born from 277 cloned embryos – 29 cloned embryos survived long enough to undergo uterine
implantation. Likewise, a recent success in mouse cloning experienced a greater than 97% mortality rate
prior to birth. Moreover, Dolly has been found to be experiencing premature aging. Research suggests this is
the result of using a six-year-old genetic donor, with its attendant degree of age-related damage to the
telomeres. However, this problem appears to have been solved, and even reversed, in later cloning. More
recent attempts have employed techniques to fortify the genetic donor’s telomeres prior to SCNT, resulting
in clones that are experiencing delayed aging and are expected to possess extreme longevity. Unfortunately
for Dolly, these techniques arrived too late for her cloning and she has recently been reported to suffer
prematurely from arthritis. Finally, scientists have believed that SCNT bypasses the protective mechanisms
present in germ cells, such as sperm and ova, which correct DNA errors. Although this hypothesis has not
yet been tested, this hypothesis suggests that with current techniques, clones are at a higher risk of
developing cancers and other mutation-related conditions.

CLONING OF MAMMALS:-

Is Dolly's death a warning?7

The death of Dolly the sheep,8 the first animal to be successfully cloned from an adult cell,
is as much a reminder of the dangers of cloning, as was her controversial birth six years ago. 9 The heated
debate over the ethics of cloning a human being has only become more intense since then.

Dolly's creator, Dr Ian Wilmut of the Roslin Institute in Scotland, is himself one of the
fiercest critics of human cloning.10 He and other scientists say that in all likelihood the life of a cloned
human baby would be brutally short or burdened with grim handicaps.11 This is reflected in the extremely
high number of miscarriages — as many as five out of six implanted cloned animal foetuses end in
spontaneous abortion.12

And some evidence — including the circumstances of Dolly's death — suggests clones
may age prematurely because their DNA source is older.

7
Richard Ingham; Posted Mon, 17 Feb 2003

8
Scientists decided to end Dolly's life at age 6 - about half the life expectancy of her breed - because a veterinarian confirmed she
had a progressive lung disease, according to the Roslin Institute, the Scottish lab where she was created and lived.

9
Sheep can live to 11 or 12 years.

10
"It is disappointing that so little is known about these events during the early development of cloned embryos."

11
Many cloned offspring die within the first 24 hours of birth from malformed heart, lungs and kidneys. Others, apparently
healthy at birth, survive longer but then die suddenly.

12
In the case of the world's first cat, a creature called Cc who was born in February 2002, researchers made 188 cloning attempts,
which created 82 embryos but led to only one successful pregnancy.
 4

Another is the risk that the cloning process somehow hands on tiny flaws that later cause
13
chronic ill health.

"Ninety-nine percent (of cloned human embryos) will fail to come to term and of the
one percent that might live, a high percentage will die shortly after birth because of
gene expression problems."14

The Birth of Human Cloning

1. Human Replicative Cloning

Advances in mammalian replicative cloning have not proceeded without the threat or
promise of human application. In December of 1997, Richard Seed, a Chicago nuclear physicist with a
background in bovine embryo transfer techniques, proclaimed his intent to clone a human being within
eighteen months. The announcement quickly gained Dr. Seed public notoriety and ripened popular debate on
the ethics and legality of human cloning technology. However, as of thirty-six months past his self-imposed
deadline, Dr. Seed has failed to report any successful cloning, and has since been dismissed as a dreamer.
Others have been more successful than Dr. Seed. On December 16, 1998, almost exactly one year after
Seed’s announcement, a team of researchers from Kyunghee University Hospital in Seoul, South Korea,
reported that they had created an embryonic human clone by fusing the nucleus of an adult human cell with
an enucleated human ovum. Although the team reportedly destroyed the embryo at the four-cell stage, and
their data was later questioned, the researchers suggested that implantation of the embryo would have
resulted in a viable pregnancy and the birth of a human clone. Experts remained sceptical about the potential
success of the experiment, given the relatively primitive technique employed. Others noted, however, that
the experiment signalled the inevitable human application of cloning research. Forays into the territory of
human cloning have even occurred unintentionally. In November of 1998, scientists at the Tokyo University
of Agriculture inadvertently applied cloning techniques by intentionally fusing the nuclei of cancerous
human white blood cells with bovine egg cells. The University promptly apologized for the experiments and
emphasized that the researchers had neither intended to produce human clones nor used human ova. The
next attempt at human replicative cloning appears to be developing among members of the Raelian Religion,
whose members believe that life on earth was created scientifically by extraterrestrials. This religious group
has established a service called CLONAID® which will provide cloning services for fees as a low as
$200,000. Although CLONAID® has yet to announce any success; the corporation was reported to have
found customers in the parents of a 10 month old child reportedly lost to medical malpractice in a hospital.

2. Human Therapeutic Cloning

Although still in its naissance, human therapeutic cloning is also undergoing active
research. In November of 2001, Advanced Cell Technology, Inc. of Worcester, Massachusetts, published
their success in the creation of cloned human embryonic cells. Although the cloned embryos did not
progress past the six-cell stage and no attempt was made to guide their eventual differentiation into
particular cell lines, the authors stated that the study’s specific purpose was to explore the foundations of
therapeutic cloning in humans.

LEGAL RESPONSE:-

13
A team led by Jerry Yang at the University of Connecticut found last year that cloned cows had flaws in nine out of 10 genes
studied on their X-chromosome — one of the two sex chromosomes that determine a mammal's gender.

14
Females have two X chromosomes, whereas males have an X and a Y chromosome. Among females, one of the X
chromosomes is "silent" — it does not activate genes. Among the cloned cows, the flaws meant the copy of the X chromosome
was incompletely switched off. The cow's protein-making machinery went haywire, with catastrophic results for the animal's
survival.
 5

Developments in animal cloning and the beginnings of human application have quickly
inspired reactions from legislative bodies around the world. While these reactions were largely negative,
only a small amount of the proposed legislation to regulate or ban human cloning has actually been enacted.

United States

On March 4, 1997, less than one week after the publication of Dolly's cloning, then -
President Clinton announced, “no federal agency may support, fund, or undertake [human cloning
research].” President Clinton also petitioned the scientific and medical communities to abide by a voluntary
moratorium on private human cloning research until the National Bioethics Advisory Commission
(“NBAC”) and the entire nation “has had a real chance to understand and debate the profound ethical
implications of the latest advances.” The NBAC, whose competence to address the issue has been seriously
questioned, unanimously condemned the technology three months later and recommended a federal ban on
any attempt at replicative cloning.

European Union

The European Union (“EU”) has achieved the greatest success in banning human cloning.
The EU’s anti-cloning policy was first revealed on May 29, 1997, when the European Council
unequivocally condemned this technology. Next, on January 15, 1998, the EU Parliament called on member
states to prohibit human cloning through ratification of the supplement to the Council of Europe Human
Rights and Biomedicine Convention. Finally, with Directive 98/44, whose deadline for ratification by
member states passed on July 30, 2000, the EU precluded the patentability of human cloning inventions by
making any process for cloning human beings un-patentable on the grounds that “their commercial
exploitation would be contrary to public order or morality.” The directive was released in response to the
University of Edinburgh’s Patent No. EP 0695351, a European patent issued in December of 1999 by the
European Patent Office, for the “isolation, selection and propagation of animal transgenic stem cells.” The
controversial portion of the application, claim 48, describes a method of SCNT that could be applied to
humans. Although the University denied any intention to engage in human cloning, critics noted that the
patent covers this endeavour through its use of the overly-broad term “animal,” without a “non-human”
modifier. The University has appealed the invalidation of its patent, but the University is not expected to
succeed because of the clear language in the directive.

United Kingdom

The United Kingdom became the first nation to specifically authorize human cloning. On
November 15, 2001, the High Court ruled that human embryos created through SCNT do not satisfy the
statutory definition of “embryo” under Britain’s Human Fertility and Embryology Act of 1990, since such
embryos do not involve the fertilization of an ovum with a sperm cell. As a result, Mr. Justice Crane
concluded that human cloning through SCNT is currently not prohibited. In response, British government
officials are said to be planning to appeal the ruling, as well as quickly introduce new legislation in the event
that their appeal fails.

South Korea

Anyone convicted of cloning a human in South Korea would face 10 years in prison, under
a bill now finalized by the government. The bill will ban all forms of human cloning in the country and
could come into force within months.

A ban on human cloning in Korea became a pressing issue in July when a US-based cult
claimed that it had implanted a cloned embryo into a Korean woman two months before. There has been no
confirmation of the pregnancy since.
 6

The Life, Ethics and Safety Measures bill also outlaws human cloning as part of
embryonic stem cell (ESC) research, the genetic treatment of embryos and foetuses and the use of a person's
genetic information in relation to education, employment or insurance.

However, the inclusion of ESC research in the ban has angered Korean scientists. ESCs
have the potential to become any cell in the body and researchers believe they could provide powerful new
treatments for disease such as Parkinson's and diabetes.

SHOULD PATENTS FOR HUMAN CLONING INVENTIONS BE ALLOWED:-

Position in US:-

The US Patent Law specifies the general field of subject matter that can be patented and
the conditions under which a patent may be obtained.

In the language of the statute, any person who "invents or discovers any new and useful
process, machine, manufacture, or composition of matter, or any new and useful improvements thereof, may
obtain a patent" subject to the conditions and requirements of the law. By the word "process" is meant a
process or method, and new processes, primarily industrial or technical processes, may be patented. The
term "machine" used in the statute needs no explanation. The term "manufacture" refers to articles, which
are made, and includes all manufactured articles. The term "composition of matter" relates to chemical
compositions and may include mixtures of ingredients as well as new chemical compounds.

These classes of subject matter taken together include practically everything, which is
made by man and the process for making them.

The US Patent Law specifies that the subject matter must be "useful." The term "useful" in
this connection refers to the condition that the subject matter has a useful purpose and also includes
operativeness, that is, a machine which will not operate to perform the intended purpose would not be called
useful, and therefore would not be granted a patent.

Interpretations of the statute by the courts have defined the limits of the field of subject
matter, which can be patented, thus it has been held that printed matter cannot be patented.

In the case of mixtures of ingredients, such as medicines, a patent cannot be granted unless
there is more to the mixture than the effect of its components. (So-called patent medicines are ordinarily not
patented; the phrase "patent medicine" in this connection does not have the meaning that the medicine is
patented.) A patent cannot be obtained upon a mere idea or suggestion. The patent is granted upon the new
machine, manufacture, etc., as has been said, and not upon the idea or suggestion of the new machine. A
complete description of the actual machine or any subject matter sought to be patented is required.

A critical examination of US Patent Law and its application to human cloning inventions
leads to the following three conclusions:

1. Human Cloning Inventions Are Patentable:

Inventions relating to human cloning clearly meet the requirements for patentability in US
because such technology can satisfy proper subject matter and utility requirements. In addition, these
inventions are not precluded in any way from satisfying novelty, non-obviousness, disclosure and
enablement.
 7

For patenting purposes, the only relevant distinction between human and animal cloning
rests on questions of morality, which should not be relied upon to preclude the patentability of new
technologies.

Procedures for Human Cloning Are Patentable Subject Matter

In order to be patentable, a patent application must cover patentable subject matter. What
counts is pretty broad: articles of manufacture, compositions, devices, processes, business methods,
software, genes, and many other items. In fact, one court described patentable subject matter as "anything
under the sun made by man." What counts as patentable subject matter has expanded and shrunk over time.
Right now, we are at a high water mark for patentability, with algorithms, software, business methods, and
the human genome all pushing the boundaries.

The Court of Appeal said in its decision in the case of State Street Bank15 that, in
determining whether a patent's subject matter is an abstract idea - which is un-patentable - or not, the focus
needs to be on "the essential characteristics of the subject matter, in particular, its practical utility." In other
words, even something that may be an abstract idea, like a mathematical algorithm, can receive a patent if it
can be "applied in a 'useful' way."

The US Patent Act permits the patenting of an invention representing a “process, machine,
manufacture, or composition of matter.” The courts have consistently interpreted this language to include
developments in biotechnology, including those claiming processes employing the manipulation of living
organisms. For example, in In re Mancy,16 the Court of Customs and Patent Appeals upheld the patentability
of a process for creating antibiotics through the provision of specific nutrients to the fungus Streptomyces
bifurcus. Likewise, in Diamond v. Chakrabarty,17 the Court of Customs and Patent Appeals upheld the
patentability of a process for transforming bacteria into a strain capable of degrading oil.

In addition, an early policy precluding the patentability of medical and veterinarian

therapies does not prevent the patenting of human cloning inventions. This policy, illustrated in the case of
Morton v. New York Eye Infirmary18 has since been firmly overturned. In Ex Parte Scherer,19 the Patent
Office Board of Appeals held that “There is nothing in the patent statute which categorically excludes
[methods of treating the human body], nor has any general rule of exclusion been developed by decisions.”

In Amgen Inc v. Chugai Pharmaceuticals Pvt Ltd.20 the patent on the production of a
protein (erythroprotien) occurring in the human body through genetic engineering was held to be valid. The
invention related to a technique of producing EPO which involved isolating the genetic code for the protein.
After the genetic code of a protein was isolated, it was introduced into a bacteria or mouse with the help of a
cloning vector. This process used DNA as vector. The gene grew inside the bacteria through a natural
process.

15
State Street Bank & Trust Co. v. Signature Financial Group, 149 F.3d 1368 (Fed. Cir. Jul. 23, 1998).
16
In re Mancy, 499 F.2d 1289, 182 USPQ 303 (CCPA 1974)

17
447 U.S. 303 (1980).

18
Morton v. New York Eye Infirmary, 17 F. Cas. 879 (C.C.S.D.N.Y. 1862) (No. 9865).

19
Ex parte Scherer, 103 USPQ 107.

20
Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200 (Fed. Cir.).
 8

In In re Bell21 also the claim was with respect to a genetically derived protein called Insulin
Growth Factor. The patent was granted.

Therefore on the basis of the above developments we can say that procedures for human
cloning are patentable subject matter.

Human Cloning Possesses Sufficient Utility for Patenting

The US Patent Act also limits patentability to inventions that are “useful.” In general, the
courts have interpreted “useful” broadly, finding utility wherever the disclosed invention is actually
“operable and capable of satisfying some function of benefit to humanity.” More specifically, the utility
requirement can be analyzed by breaking it into its three components: general, specific, and beneficial
utility.

a) General Utility - The issue of general utility rests upon “whether or not the invention as
claimed can really do anything.” Human cloning inventions have a utility. Replicative cloning has its utility
being a mechanism for human asexual reproduction and in the creation of genetically identical persons.
Similarly, therapeutic cloning has utility in providing a method for creating genetically precise human
organs for transplantation.

b) Specific Utility - Specific utility is defined as the workability of the invention to fulfil
its intended goal. For human cloning inventions, specific utility is the success in creating cloned organs or
individuals.

c) Beneficial Utility - The doctrine of beneficial utility has been interpreted to require that
“the invention has some minimum social benefit, and not be completely harmful.” However, applying this
doctrine to preclude patentability may not be possible as it has been limited to activities that were believed
(at least at the time) to be inherently bad. For example, beneficial utility was often invoked in the late
nineteenth century to deny patents on gambling devices and fraudulent medicinal products. The objectives
of human cloning do not meet the “completely harmful or deleterious” standard. On the contrary, not only
are the creation of children and the treatment of organ failure not inherently bad, but these practices are
highly valued in society. Moreover, application of the beneficial utility requirement to human cloning
inventions is not appropriate. It has been argued that, “patent protection for a new technology normally
should not be denied on the basis of speculation about potential negative consequences.” This argument is
supported by illustrating the volatility of moral views on inventions; discoveries such as birth control pills
were transformed from illegality to legal and popular usage within the span of a mere several decades.
Equally important, the patent system has neither the expertise nor the resources to competently evaluate the
often-changing morality of these developing technologies. The beneficial utility requirement, therefore,
should not serve as a basis to prevent patenting human cloning inventions.

2. Human Cloning Inventions Are Not Precluded From Satisfying The Other
Patentability Requirements:

Finally, human cloning inventions are not precluded from satisfying the other statutory
requirements for patentability. There is nothing specific to human cloning inventions that prevent them from
satisfying the novelty requirements or the non-obviousness requirement or the disclosure and enablement
requirements of US Patent Act.

21
In re Bell, 991 F.2d 781 (CAFC 1993).
 9

Patentability Should Not Be Used As A Means Of Regulation:

First, patentability should not be used as a means of regulation of developments in the field
of Science and Technology because neither the US Patents Act nor any other law confers the US Patent
Office with such an authority. Such a regulatory role is better left for the Legislature to perform.

Second, the patent system lacks expertise and resources necessary to engage in regulating
technological developments. The USPTO is not in the position to hold hearings and weigh societal concerns
regarding every new technology it reviews.

Third, patent law is all or none: the only options allowed by the PTO are to either grant a
patent or not grant a patent. Therefore, the PTO is not in the position to provide the wide range of options
that adequate regulation often requires.

Fourth, the nature of patent law prevents a direct regulation of specific activities. A refusal
to grant a patent for a specific technology does not prevent that technology from being applied. Instead, the
PTO merely prevents the inventor from gaining a right to exclude others from making, using, and selling
that technology. The denial of a patent will still leave the technology for use and further developments. This
can be emphasized by the fact that uncertainty as to grant of patent has not stopped research in the field.

On the contrary, by not granting a patent, the PTO actually enables anyone to practice the
disputed technology, instead of merely the inventor. This reduces the regulation rather than putting a check
on disputed technologies.

Fifth, patent protection of a technology is limited to twenty years after the first disclosure,
barring any delays in the patent prosecution process. Once the patent expires, the technology is placed in the
public domain for anyone to practice.

Finally, the Treaty on Trade-Related Aspects of Intellectual Property Rights (“TRIPs”), to

which India is a signatory, obligates nations to permit patenting all technologies. Article 27 of section 5
provides, “patents shall be available for any inventions, whether products or processes, in all fields of
technology, provided that they are new, involve an inventive step and are capable of industrial application.”
This article, however, does permit nations to “exclude from patentability inventions, the prevention within
their territory of the commercial exploitation of which is necessary to protect public order or morality,
including the protection of human life or health” As previously discussed, however, the PTO lacks the
resources, qualifications, and mandate to regulate technology on moral grounds.

Position in India:-

The Indian Patent Office is unlikely to grant patents for processes for cloning human
beings or animals, processes for modifying the germ line, genetic identity of human beings or animals, uses
of human or animal embryos for any purpose on the ground that they are against public order and morality.22

HUMAN CLONING – A DEBATE:-

Because science is both a public and a social enterprise and its application can have
profound impact, society recognizes that the freedom of scientific enquiry is not an absolute right, and
scientists are expected to conduct their research according to widely held ethical principles. There are times
when limits on scientific freedom must be imposed, even if the individual scientist perceives such limits as
an impediment. Much hue and cry has been caused since the issue of cloning of mammals has come up. The
success in cloning mammals opened gates for research in cloning of human beings also. It is this aspect of
22
Indian Patents Act 1970, Sec. 3 (b).
 10

cloning that is the centre of all hub-hub. Beyond the safety concerns lies another reason to ban the cloning of
humans – what effect human cloning would have on the social structure? As a society, which values the
diversity amongst them, we can well imagine how uncomfortable it could be to have friends and neighbours
creating designer children.

The several questions that are being thrown at scientists and judiciary all across the globe
vary from economic, to social, to biological aspects of human cloning. “Who will be the parents of the
cloned ‘child’?” “Do we want to play God?” “Will the growth and the life of an artificially created human
being be as normal as natural human beings?” And many more of such questions just never seem to seize.

ARE WE PLAYING THE ROLE OF GOD???

To some, each new technology, as it appeared, threatened to shake the ground on which
familial relationships were predicted. To others, this new technology promised to assist in the creation of
loving, if not ‘traditional’, families. The fear of reproductive technology has, in one form or another, been
largely the fear of abandoning traditional forms of familial interactions, and the fear of welcoming choice
autonomy into the centre of domestic matters.

Cloning may also be envisioned as only a superficial and not yet adequately understood
technology. Some, for instance, may argue that cloning is not a form of human reproduction, but a technique
of replicating people.

We may be inadvertently harming the strength and survival of our species by reducing the
variety of children. Furthermore, we know that in the past, political rulers have attempted to shape the
composition of human race. One race or particular gene pool has been preferred over others, and attempts
have been made to ‘eliminate’ undesirable gene pool.

It is simply wrong to use cloning to experiment with the creation of human life. Human
beings are not simply genes and molecules. Here our sense of morality and human dignity dictates that we
prohibit the cloning of humans.

Family23

Up till now, every child has had two parents. A cloned individual will have a biogenetic
link to one lineage only. The salient intrinsic difference is that cloned individual would have only one
genetic parent and be an end product of one biological lineage.

Historically and culturally, families have in all their variety of cultural forms been key
institution for the structuring of the society and the transmission of knowledge, value, and practices, as well
as for training in moral dispositions such as empathy, fidelity, honesty, and altruism.

The second intrinsic difference is that the existence of genetic ‘doubles’ is moved to a new
location in the family or kinship structure” the cloned genetic twin would be older. The new kinship location
of genetic twinning intersects with the danger of ‘objectification’ or means-to-an-end control of child.

The third intrinsic difference is that the DNA of the existing individual is selected
deliberately and in its entirety to be the source of a new individual, without leaving anything to the chance
inherent in ordinary conceptions, and hence, more danger of an overt or tacit expectation that the product
will look or function in a certain way.

23
Lisa Sowle Kahill; “No Human Cloning: A Social Ethics Perspective”, Hofstra Law Review, Vol 27, No.3, Spring 1999.
 11

The genetic-near identity of the parent and child may hinder the ability for both to see the
child as an independent individual, for whom maturity will require separation from their parents and the
development of a unique identity.

Market Exchange and Commodification

Research with public funding would be easier to control and less market driven than
private research. Privately funded research would be motivated by foreseeable profits, and success in
marketing the result would easily overtake the other ethical considerations.

Ethics and Public Policy

Simply put, cloning is wrong because it violates certain fundamental rules about
appropriate relationships between humans and nature, or human and God; because it takes away the
necessity of sexual intercourse, and because it confuses our common understanding of kinship and
separation of generations.

Many people may argue that cloning would harm children as well as society. Children
would be harmed by the excessive expectations brought to their births by the adults who believed that
genetic duplication guarantees of all physical as well psychological traits. It would be harmful for the
society, as it would encourage a kind of commercialization.

THE FLIP SIDE:-

Cloning can be seen as another in the line of increasingly impressive technological options
to sexual reproduction – “one among a number of reproductive options, albeit an asexual method.” Human
cloning may seem as routine as In-Vitro Fertilization now does, once cloning leads to birth of actual
children, and once families include clones.

The notion that cloning creates exact copies of existing or dead individuals is just not true.
Though an individual manufactured by cloning would posses the same genetic sequence, other factors, such
as structural and metabolic influences of the enucleated egg and the differentiated cell as wee as influences
during gestation, non genetic factors such as nutrition, home environment, education, economic situation,
and culture also substantially affect the development of an individual.

Cloning is not intrinsically good, nor intrinsically bad. When done for good purpose, it is
ethically acceptable, and when the motivation is bad, the act itself is bad as well. For example, when done to
circumvent infertility, or for having a child who is genetical twin of a child in need of bone marrow
transplant – cloning is arguably for good reasons. On the other hand, if done for purely commercial purpose,
or to satisfy ego – it is undesirable.

But it is difficult to implement rules and regulations where acts are permitted or prohibited
based on actors motivation. Thus this public policy has been found to be unworkable.

Before making any attempts to ban human cloning, it is extremely critical to keep it
flexible for future scientific developments and yet address the crucial moral issues. Genetic science
including cloning technology, will continue to play a key role in the discovery of cures and treatments for
diseases and the improvement of our quality and quantity of agricultural products, as well as improving our
basic understanding of the life sciences. The mystery of creating human life is too grand, too awe inspiring,
to be replaced by genetic manipulation.
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It is essential that other avenues of genetic research and non-human cloning research
continue.

Before one can accept a public policy based on a consensus that cloning is wrong and a
popular vote to prohibit its use, one must ask whether such a prohibition will impinge any fundamental right.
Supreme Court decisions have carved out large areas of family law and reproductive decision making as
beyond the appropriate scope of governmental authorities.

To abridge a fundamental right, they must show that here is a compelling state purpose to
be achieved – such as the prevention of a probable and serious harm.

The cloning debate, like the debates surrounding the introduction of many of the new
genetic technologies, often reflects the proposition that if science can do something, it should be done.
Scientists introduce new technologies with inflated promises of potentially solving the world’s problem –
genetically engineered crops to end world hunger, or mapping the human genome so as to end disease.
Researchers and their investors promote these technologies without proof of actual benefit or lack of harm.
In reality, many of these “miracles” inventions could cause harm, and today few of the promised benefits
have been realized.

CONCLUSION:-

Human cloning technology satisfies the requirements of patentability under the US Patent
Act. As a result, human cloning technology should be afforded the right to obtain a patent by the PTO. The
PTO should not attempt to regulate the safety or the procedures employed through the grant or rejection of a
patent. Although human cloning technology cannot be regulated under the Patent Act, the gravity inherent in
the creation of human life and human organs requires significant regulation and supervision. Given the
premature and uncertain state of human cloning, regulation may require the effort of multiple agencies, on
the national and international level.

However, human cloning is also certain to have novel and profound legal ramifications on
many non-medical aspects of society. These include the uncertain rights of cloned individuals, genetic
donors, and donors of ova, expansion of the wrongful birth doctrine, as well as the emergence of the new
crime and possible tort of “genetic identity theft.” These considerations will require legislators and experts
in the areas of constitutional law, criminal law, family law, and tort law to re-examine and update their fields
accordingly.

And cloning on a large scale would be bad news indeed for human evolution, for it would
encourage stagnation rather than a dynamic mixing of the gene pool. Homo sapiens would mark time as a
species.

Bibliography
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1. “The Ethics of Biotechnology”, Jonathan Morris, Chelsea House Publishers, USA, 2006.
2. “Cloning after Dolly: Who’s still afraid?” Gregory Pence, Rowman & Littlefield Publishers, New
York, 2004.
3. “The Scalpel and the Butterfly: The War between Animal Research and Animal Protection”,
Deborah Rudacille, Farrar, Straus and Giroux, New York, 2000.
4. “Who is Afraid of Human Cloning?” Gregory Pence, Rowman & Littlefield Publishers, New
York, 1997.
5. “Redesigning Humans: Choosing Our Genes, Changing Our Future”, Gregory Stock, Houghton
Mifflin, New York, 2002.
6. “The Biotech Century: Harnessing the Gene and Remaking the World”, Jeremy Rifkin, Penguin
Putnam Inc., New York, 1998.
7. www.bioethics.gov/reports/cloningreport/
8. www.nih.gov/sigs/bioethics/
9. www.advancedcell.com
10. www.cloninginformation.org/index.html
11. www.reproductivecloning.net/index.html