ALIGARH MUSLIM UNIVERSITY

CENTRE MURSHIDABAD

SESSION : 2020-2021

End-Semester

Jurisprudence Project

On

Concept of Ownership with respect to Genetic Material (DNA) : A

Jurisprudential Review

SUBMITTED TO:- SUBMITTED BY:-

Miss. Shaila Mehmood Mohd Daniyal Siraj
Assistant Professor 18BALLB55
Department Of Law GL0749
AMU-CJM

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 ACKNOWLEDGMENT

I feel highly elated to work on the project “Concept of Ownership with respect to Genetic
Material (DNA) : A Jurisprudential Review”. The practical realisation of the project has
obligated the assistance of many persons. Firstly, I express my deepest gratitude towards
Miss Shaila Mehmood, Faculty of Law, to provide me with the opportunity to work on this
project. Her able guidance and supervision in terms of her lectures were of extreme help in
understanding and carrying out the nuances of this project.

Some typography or printing errors might have crept in, which are deeply regretted. I would be
grateful to receive comments and suggestions to further improve this project.

Mohd Daniyal Siraj

Roll. No. 55
Semester VI

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 TABLE OF CONTENTS

Introduction 1
Research Methodology 3
Problem of the Study 3
Rationale 3
Objective 3
Review of Literature 4
Hypothesis 6
Nature of the Study 6
Chapterization 6
Time Limit 6
Limitation of the Study 6
Concept of Genetic Material and Sharing 5
Theory of Immanuel Kant 8

Ownership of Gene Sequences and Genetic Information 10

Proposed Directive on the Legal Protection of Biotechnological Inventions 12
Acknowledgments II

Conclusion 16
Findings 17
Bibliography 18
 CHAPTER I: INTRODUCTION

This project, primarily is the normative case against ownership of one's genetic information
along with the source of that information (usually human tissues samples). The argument
presented here against such "upstream" property rights is based primarily on utilitarian
grounds. This issue has new salience thanks to the Human Genome Project and
"bioprospecting" initiatives based on the aggregation of genetic information, such as the one
being managed by deCODE Genetics in Iceland. The rationale for ownership is twofold:
ownership will protect the basic human rights of privacy and autonomy and it will enable the
data subjects to share in the tangible benefits of the genetic research. Proponents of this
viewpoint often cite the principle of genetic exceptionalism, which asserts that genetic
information needs a higher level of protection than other kinds of personal information such
as financial data. We argue, however, that the recognition of such ownership rights would
lead to inefficiency along with the disutility of genetic discoveries. Biomedical research will
be hampered if property rights in genes and genetic material are too extensive. We contend
that other mechanisms such as informed consent and strict confidentiality rules can
accomplish the same result as a property right without the liabilities of an exclusive
entitlement.

RESEARCH METHODOLOGY

Problem of the Study

As a result of the International Human Genome Project genetic information is rapidly

multiplying. To avoid some of the problems regarding the availability and use of genetic
information, it is sometimes suggested to apply the concept of ownership. This article focuses
on the clarification of the status of genetic material and genetic information, obtained as a
result of screening and counseling of individual patients. First, some philosophical theories of
ownership are examined for a justification of the use of the concept of ownership with regard
to the human body. Next, arguments with regard to ownership of the human body are
examined. The results of this analysis are applied to genetic material and genetic information.

Rationale

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The project here presented is extremely important due to the nature of the topic and its rising
demand, which can lead to easy misuse of the same. Here it is to be kept in mind that
paternity test have a severe linkage with the morality and ethical legality.

Objective

The objectives of this project are:

1. To study the concept of Genetic Material and Ownersip

2. To study the ownership of genetic material and general exceptionalism
3. To study the theories of genetic information.

Review of Literature

1. Doris Teichler Zallen, Rutgers University Press, 2008, To Test or Not to

Test: A Guide to Genetic Screening and Risk Tests are a standard part of modern
medicine. We willingly screen our blood, urine, vision, and hearing, and submit to a
host of other exams with names so complicated that we can only refer to them by their
initials: PET, ECG, CT, and MRI. Genetic tests of our risks for disease are the latest
trend in medicine, touted as an approach to informed and targeted treatment. They
offer hope for some, but also raise medical, ethical, and psychological concerns for
many including when genetic information is worth having.

To Test or Not to Test arms readers with questions that should be considered before
they pursue genetic screening.

2. Alexandra Plows, Routledge 2011, Debating Human Genetics:

Contemporary Issues in Public Policy and Ethics

Debating Human Genetics is based on ethnographic research focusing primarily on

the UK publics who are debating and engaging with human genetics, and related bio
and techno-science. Drawing on recent interviews and data, collated in a range of

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 public settings, it provides a unique overview of multiple publics as they 'frame' the
stake of the debates in this emerging, complex and controversial arena.
The book outlines key sites and applications of human genetics that have sparked
public interest, such as biobanks, stem cells, genetic screening and genomics. It also
addresses the 'scientific contoversies' that have made considerable impact in the
public sphere - the UK police DNA database, gene patenting, 'saviour siblings', and
human cloning. By grounding the concepts and issues of human genetics in the real
life narratives and actions of patient groups, genetic watchdogs, scientists, policy
makers, and many other public groups, the book exemplifies how human genetics is a
site where public knowledge and value claims converge and collide, and identifies the
emergence of 'hybrid publics' who are engaging with this hybrid science.

Hypothesis

The concept of ownership is very closely linked to that of Genetic Information's use and
misuse. It is also to be kept in mind that these tests are used just for the purpose of
confirmation and not to be used for the immoral benefits out of the result.

Nature of the Study

The nature of the study in this project is doctrinal and is primarily descriptive and analytical.
This project is largely based on primary sources of data such as cases and reports of
committees, however secondary & electronic sources of data have been referred to a great
extent. Books, case laws, journals & other reference as guided by faculty of Jurisprudence are
primarily used for the completion of this project.

Chapterization

This project has been divided into 5 chapters. Chapter 1 comprises of Introduction and
Research Methodology. Chapter 2 includes Concept of Genetic Material and Sharing.
Chapter 3 details the Theory of Immanuel Kant. Chapter 4 talks on the Ownership of Gene
Sequences and Genetic Information and the 5th one talks about the Proposed Directive on the
Legal Protection of Biotechnological Inventions.

Time Limit

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It took the author roughly 10-15 days to complete this project in its entirety.

Limitation of the Study

Due to paucity in time and resources the author has dealt in brief the concept of Dharma and
Justice in Indian philosophy and the concept of Ownership of Genetic material. With respect
to the Idea of Ethic and morsle in relation to which a detailed account has not been provided
as it would have been beyond the scope of the topic of the project and only relevant aspect of
his concept has been discussed which included his view on the concept of Genetic Testing.

CHAPTER II: CONCEPT OF GENETIC MATERIAL AND SHARING

Genetic Information
Genetic information broadly refers to all of the currently known genetic data for all living
organisms. It can also refer to the genetic composition of one individual and their
families. Many individuals express concern that a positive finding on a genetic screening
test will result in discrimination and stigmatisation because they are out of the norm.
Another concern raised is that the release of genetic information may result in an
individual‟s loss, for example, of the inability to get insurance, or employment if genetic
information crosses into the public domain (Orentlicher 1990: 1005). Nowadays, genetic
information is used not only in the doctor‟s office, but also beyond. For example, genetic
information in a variety of forms is found in courts of law as a way of proving or
disproving paternity, determining immigration status, in criminal cases involving genetic
materials, by the military for soldier identification purposes and by medical aids and other

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insurance companies. Genetic information is seen as different from other biological
tissues in that it potentially involves more “broad-ranging features of an individuals‟
health status” and carries implications for relatives (Skene 2002: 49, Gillet and
McKergow 2007: 2094). Within the ambit of health and wellness, genetic information is
being used in reproductive and fertility health, disease diagnosis and treatment,
epidemiological studies, bioinformatics and pharma-cogenomics. The complex questions
about who ought to benefit and about how individuals, families and communities can be
protected against harms are most pressing at this time.

Genetic Exceptionalism
Genetic exceptionalism despite that the gifting and sale of certain parts of the body has
become a (debatably) acceptable practice in some parts of society, such as through organ
donation, blood donation, sperm donation, ovum selling, selling of breast milk and the
like, there has been an attitude of what is termed “exceptionalism” regarding genetic
information. This is most likely due to the „mystique‟ around genetics, since the concepts
can be highly abstract and difficult to understand, but there also tends to be much
suspicion about the nature and power of the contents of genetic information. Some
arguments for and against genetic exceptionalism The arguments for classifying genetic
information as exceptional are generally grounded in the belief that genetic information is
uniquely sensitive information owing to its “prophetic, predictive, shared and symbolic
nature” (McGuire et al. 2008: 500).The most obvious example of this is that of the genetic
relationship between monozygotic twins. Since they share such a high percentage of their
genetic makeup, if the one were to discover a deleterious mutation, it would be highly
likely that the other twin would have it as well. As familial relationships move further
apart (genetically), this probability decreases, but the information may nevertheless be
relevant to family members and therefore affect decisions that they make about their
healthcare, and in some cases, reproductive choices. This is because an individual
receives not only information relating directly to her, but she also receives the genetic
history of her family or in some instances, her extended family (husband, motherin-law,
father-inlaw). Thus, the argument goes, genetic information should be considered as
exceptional. It has been argued that genetic information thus should be offered to all
family members as they have a „right to know‟ (O‟Neill 2001: 703-704). On the other

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hand, it may be argued that genetic information is neither “exceptional nor ethically
different from other medical information” (Murray 1997: 63).Murray argues that there are
medical issues such as elevated cholesterol or exposure to an infectious disease that
perhaps ought to be shared with family members as well. There may also be an argument
for sharing of information for public health benefit and so, the age old tension between
individual rights and legitimate public health needs arises.

Ownership of Genetic Information

Since genetics touches so intimately on an individual‟s life, as does any other

healthrelated information, it is often thought of as falling into a property “paradigm” since
individuals tend to think of themselves as proprietors of their genetic material (Andrews
1986: 29; de Witter and ten Have 1997: 51; Gillert and McKergow 2007: 2095; Campbell
1992: 40). In their discussion on ownership of genetic material and information, de Witte
and ten Have (1997) identified a few possible owners:

a) the individual with the particular genome;

b) the scientist or company that discovered the particular

genes or nucleotide sequences;

c) humankind in general (as noted in the UNESCO declaration).

I would add another category: a group of people who happen to share an identical set of
specific nucleotides for a sequence in question. In order to discuss the issue of genetic
ownership, a deeper debate arises: can a person justifiably make the claim to be owners of
themselves? Despite the strong intuition that a person is the owner of themselves, there is
little principled moral argumentation to prove that people are indeed in possession of
rights of self-ownership. In spite of this, there are strong legal and legal-ethical arguments
that uphold individual liberty, freedom, autonomy and dignity aimed to protect the
individual from intrusions on or into her body (bodily integrity).

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 CHAPTER III – THEORY OF IMMANUEL KANT

The philosopher, Immanuel Kant argues that peopleought to be treated as ends in

themselves (not used). They are ends in themselves because they are rational being that
have inherent worth and dignity. Because of their intrinsic value, they are deserving of
respect at all times. This respect is to be applied by a person towards his- or herself as
well as towards others. In applying this respect, some of the principles of individual
liberty are protected by this principle of ends. On the other hand, freedoms that constitute
an indignity towards self and others, such as commoditisation (selling) of the body, are
prohibited by this view. Kant‟s views against self-ownership are underpinned by the
principle of respect for persons, a privilege of man by way of his humanity. Taylor (2004:
71) explains Kant‟s position writing, “In MM [Metaphysics of Morals], Kant asserts that
someone can be his own master but cannot be the owner of himself (cannot dispose of
himself as he pleases) - still less can he dispose of others as he please - since he is
accountable to the humanity in his own person.” Since, the principle of self-ownership
allows actions such as self-mutilation and suicide and asserts that the individual is the
final arbiter over herself; it is against the principle of treating oneself with dignity,
according to Kant.

Robert Nozick (1974), a libertarian who argues for selfownership, borrows from Kant to
argue that as humans with inherent value and dignity we ought to have the right to
freedom and from John Locke to argue that we ought to have the right to private property.
Where Kant and Nozick agree is that a person should never be treated merely as a means
to an end. On the issue of how a person should treat themselves, Nozick believes that that
is a matter of personal liberty and that the person should be able to make their decisions
without outside interference - that is, they are self owners and free to choose how they
treat themselves. Kant, in fact shares the belief in personal liberty. He sees voluntariness
and freedom from interference as essential to autonomy. Where they disagree is on the
matter of respecting oneself and what that respect means; that is, what dignity means.
Kant believes that people have a duty to respect themselves as much as they do to respect
others. If Kant, who argued for individual freedom, autonomy and choice as well as for

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respect for humanity, were present in today‟s world, how would he view ownership of
genetic information and the exceptionalism debate? It is difficult to imagine how he
would apply these moral principles to sharing, or not sharing information and owning or
not owning it.

If we were to create a maxim that said, “One should always offer to disclose one‟s genetic
information to family members or relevant others” I would consider this right and
appropriate, and I think Kant would agree as I would be demonstrating my duty to respect
myself and for others. It shows Kant‟s concept of autonomy as the principle of morality.
On the other hand, if we were to create a maxim that said, “One should always disclose
one‟s genetic information.” I would hesitate to act on this maxim. While the principle of
respect for persons denies that a person can be a self owner, it also implies that we have
autonomy, freedom and choice - individual freedoms are still upheld.

Moreover, and in a different perspective, the concept of sharing or providing one‟s

genetic information per se may not be the real issue at hand. Sometimes, benefits may
have to be weighed against harms and perhaps the concept of dignity needs to be
reevaluated. If, for example, gene patenting does not diminish a person‟s freedom,
autonomy or rational will but does provide much-needed research for significant global
health benefits, and if those health benefits can be distributed evenly among the rich and
poor, then there are some powerful moral arguments in favour of the practice. However,
since there is a disparate distribution of goods and harms globally and commercial ends
are seldom in pursuit of equality, patenting may be wrong, but not for reasons of genetic
self-ownership. It may well be, that the intense desire that most people have to control
their genetic information is not because they feel they have a philosophical attachment to
their information, but rather that they fear the negative outcomes they may experience if
they lose control over that information. It may well be that in a world with less
stigmatisation or fairer systems, people would be more willing to share and that may well
be the right thing to do.

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 CHAPTER IV – OWNERSHIP OF GENE SEQUENCES AND OF GENETIC INFORMATION

Hugo Patent Story

There has, of course, been a quite separate, and no less contentious, issue relating to the
patenting of genes: whether, and at what stage, the information and genes unravelled in
the various genome mapping projects can be patented, or otherwise protected by
intellectual property law. The patent controversy relating to the 'human genome project'
began in 1991 when the US National Institute of Health (NIH) and its employee, Dr Craig
Venter, filed the first of many patent applications in respect of thousands of sequences of
DNA from brain cells. These small DNA fragments (expressed sequence tags (ESTs)) had
been newly isolated, but the complete gene sequences and their function in the human
body were not then known. The filing of these applications incurred the dis- pleasure of
much of the international scientific world. For example, the French National Consultative
Com- mittee on Ethics condemned this patenting policy, emphasizing that the information
contained in the human genome forms part of the common heritage of humanity; an area
of knowledge which cannot be made the subject of a monopoly. It is important to identify
precisely the nature of the objection. It was not, in most cases, to the patenting of useful
benefits derived from genetic information. The patenting of complete gene sequences
whose function in the human body is known and which can be isolated and translated into
therapeutic products of commercial value, as has already been discussed, was
acknowledged by most scientists in this area. The fundamental objection, based upon a
mixture of ethical and technical factors, was that patent applications were being made in
respect of partial genetic sequences (these included both ESTs and sequence tagged sites
(STSs)) whose function in the human body was unknown and where there were no known
useful benefits immediately arising from such information. The applications raised
overlapping questions as to whether the claims were being made for discoveries or
inventions and whether it could be shown that the partial genetic sequences had sufficient
'utility' to meet patent requirements. If partial gene sequences have no known use, then we
have simply information or discoveries, without any utility. In the USA, the Patent and
Trademark Office rejected the claims on various grounds: attempts were made to meet

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some of the doubts expressed about these applications by specifying possible uses: as
forensic markers for personal identification or as diagnostic markers for disease: for
identifying human brain tissue; creation of probes; antisense oligonucleotides and vectors
for gene fragments; and marking particular human chromosomes. These uses were not
acceptable: some lacked utility; some were 'vague, indefinite, misdescriptive, inaccurate
and incomprehensible'; some that they did not adequately define the invention or provide
enough information to enable others to repeat what the applicants claimed to have done;
and also that some were obvious. Similar objections to partial gene sequences were
upheld in European patent offices; and HUGO has also confirmed the ethical position:
'Raw human genomic DNA sequences, in the absence of additional biological information
and demonstrated utility, is inappropriate material for patent filing.... [Access] to the
initial genomic sequence as it is generated will provide the maximum oppor- tunity for
research and for development of new products.' Thus the 'human genome' controversy
relating to the patenting of sequences, a controversy which also served to focus attention
upon this difficult dividing line between discovery, information and invention, has now
quietened down and any perceived threats to scientific research have also receded.

Other intellectual property rights in genomes

The genome databases contain vast, and constantly increasing, stores of information.
Commercial organizations ordinarily would expect to exercise control over access to, and
use of, such information: they are the results of their economic investment. Such
organizations, and indeed, academic institutions could protect their investment in these
databases by seeking the assistance of other types of intellectual property law, such as
copyright and related rights. This can be effected by a combination of copyright law and a
new sui generis right (created by a recent European Database.

Directive) conferred upon owners of databases to prevent unauthorized extraction and

reutilization of information from a database. The Human Genome Organization, however,
whilst reaffirming the role of patenting with regard to new processes and products using
genes, has maintained that all sequence information should be in the public domain to
provide the maximum opportunity for research and development of new products: the
human genome is part of the common heritage of humanity. The following principles

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were endorsed in February 1996 by all HUGO participants, including officers from, and
scientists supported by the Wellcome Trust, the UK Medical Research Council, the USA
National Institute of Health, the National Center for Human Genome Research, the US
Department of Energy, the German Human Genome Programme, the European
Commission, HIGH and the Human Genome Project of Japan. It was noted that some
centres may find it difficult to implement these principles because of legal constraints and
it was therefore important that funding agencies were urged to foster these policies.

(i) Primary genomic sequences should be in the public domain It was agreed that all
human genomic sequence information, generated by centres funded for large- scale
human sequencing, should be freely available and in the public domain in order to
encourage research and development and to maximize its benefits to society.

(ii) Primary genomic sequences should be rapidly released Sequence assemblies

should be released as soon as possible. Finished, annotated sequences should be
submitted immediately to the public databases. It was agreed that these principles should
apply for all human genomic sequences generated by large-scale sequencing centres,
funded for the public good, in order to prevent such centres establishing a privileged
position in the exploitation and control of human sequence information. In order to
promote coordination of activities, it was agreed that large-scale sequencing centres
should inform HUGO of their intention to sequence particular regions of the genome.
This information will be presented on HUGO's World Wide Web page which will direct
users to the Web pages of individual centres for more detailed information regarding the
current status of sequencing in specific regions. This mechanism should enable centres to
declare their intentions in a general framework, while also allowing more detailed
interrogation at the local level

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CHAPTER V- PROPOSED DIRECTIVE ON THE LEGAL PROTECTION OF BIOTECHNOLOGICAL
INVENTIONS

Clarifying and Strengthening Patent Law

In 1988, the European Commission introduced a Proposal for a Directive on the Legal
Protection of Biotechnological Inventions designed to clarify this area of the law. The
original Proposal was concerned almost exclusively with technical patent matters and was
silent on the morality of patenting in the area of biotechnology. However, from 1992,
many interest groups in the European Parliament and elsewhere focused attention on the
ethical issues and the original technical and commercial objectives of the Directive
became overshadowed by them. In early 1995, after seven years of controversy, extensive
discussions and many revisions to the document, the European Parliament rather sur-
prisingly rejected the proposed directive. Undeterred by its defeat, the European
Commission presented a fresh proposal for a directive in December 1995 which seeks to
take account of the calls by the European Parliament for clarity and more precision,
particularly in connection with the ethical guidelines. On the technical patenting side, the
Commission attempted both to clarify the rules and to emphasize, in resounding tones,
that parts of the human body (including genes) should not be patentable in their natural
state. Thus, it seeks to clarify the distinction between patentable inventions and
unpatentable dis- coveries; so the earlier ban on patenting 'parts of the human body... as
such', which involved disputes as to the precise meaning of the term as such has been
clarified. Now, 'the human body and its elements in their natural state' are not to be
considered patentable inventions whereas 'an element isolated from the human body or
otherwise produced by means of a technical process shall be patentable, even if the
structure of that element is identical to that of a natural element.5 The distinction between
discoveries and inventions is referred to both in the Recitals and the Articles: The Recitals
state:... (13) Whereas it should be specified that knowledge relating to the human body
and to its elements in their natural state falls within the realm of scientific discovery and
may not, therefore, be regarded as patentable inventions; whereas it follows from this that
substantive patent law is not capable of prejudicing the basic ethical principles excluding
all ownership of human beings.... (15) Whereas therefore it should be made clear that an

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invention capable of industrial application and based on an element isolated from the
human body or otherwise produced by means of a technical process is patentable, even
where the structure of that element is identical to that of a natural element, since no patent
may be interpreted as covering an element of the human body in its natural environment
forming the basic subject of the invention. Article 3 provides:

(i) 'The human body and its elements in their natural state shall not be considered
patentable inventions'. The Commission explains this once again: [This] draws the
distinction between a discovery and an invention... [Patentability] applies to something
that is artificial in the sense that it is a technical solution to a technical problem and has
been invented by man. Conversely, a discovery concerns something natural. The need to
draw a clear distinction provides the justification for referring, in the second paragraph, to
a technical process in contrast to what is natural. Thus the words in the natural state are
used to stress that elements of the human body are to be treated as discoveries and not to
be considered as inventions.'

(ii) Notwithstanding paragraph 1, the subject of an invention capable of industrial

application which relates to an element isolated from the human body or otherwise
produced by means of a technical process shall be patentable, even if the structure of that
element is identical to that of a natural element. The Commission's comment here is that:'
stipulates that biological material of human origin may form the subject-matter of an
invention. This provision is necessary in order to make clear that elements of human
origin must satisfy the conditions governing patentability before they can be considered
inventions.

Dealing with the Ethical Issues

Ethics and gene therapy On the ethical side, this latest proposal not only acknowledges the
importance of public policy and morality in relation to biotechnological inventions but also
specifies that 'it must be determined whether applications offend against public policy and
morality in each specific case, by means of an appraisal of the values involved, whereby the
benefit to be derived from the invention, on the one hand, is weighed and evaluated against
any risks associated therewith and any objections based on fundamental principles of law, on

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the other hand.' Thus, the 'balancing approach' as applied in the Harvard Oncomouse case is
preferred to the relaxing approach of interfering only in extreme, ab- horrent, applications.

Although the proposal claims to provide an illustrative list of inventions excluded from
patentability so as to provide national courts and patent offices with a 'general guide' to
interpreting the reference to public policy or morality, it in fact offers very few guidelines,
save in the area of gene therapy. (i) Somatic cell gene therapy Somatic cell gene therapy,
which involves alteration of genes of somatic cells in an individual patient with the intention
of alleviating disease in that individual alone, seems to pose no special ethical problems for
the Commission: products or processes concerned with somatic cell gene therapy can in
principle be patented (ii) Germ-line therapy Germ-line therapy, which involves the
modification of germ cells containing DNA which will be transmitted to, and so affect, future
generations, is much more controversial. For example, the purpose of gene modification of
sperm or ova or cells which produce them would be to prevent the transmission of defective
genes to subsequent generations. Some would prohibit all such activity. Article 13 of the
Council of Europe draft Convention on Human Rights and Biomedicine (June 1996),
provides that: 'an intervention seeking to modify the human genome may only be undertaken
for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any
modification in the genome of any descendants.' The UK National Academies have stated
that intervention in the human germ line could not be justified at the present time or in the
foreseeable future. Others are less certain and would postpone decisions until more was
known, for example, by restricting such research at present to germ-line manipulation of
animals. Germ-line gene therapy patents would also raise interesting issues as to the scope of
the rights of the patent owner. If a patented gene is inserted into humans and is then
transferred down the generations can it be said that the patent holder has monopoly rights
over such persons and their descendants for as long as the gene is protected by a patent?
Technically, of course, the monopoly right in a patented gene would extend down the line,
albeit for a limited time. However, the control would only arise in connection with any
commercial use of the patented gene; for example, if a nursing woman whose mother milk
has been enriched by the insertion of a patented gene in her mammary glands sold the milk,
or where a person sells egg cells (ova), sperm or blood incor- porating a patented gene that
can be used, say, to manufacture a vaccine. However, if a patented gene is inserted into a
person's sex cells and passed on to the next generation, there would be no infringement by a
person having children who had acquired the relevant gene, provided the activity was not
commercial! Whilst this could not be regarded as ownership of a person, it would certainly

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involve a form of limited control. All such problems are likely to be side-stepped: the
proposal for a 'biotechnology directive' provides that methods of human treatment involving
germ-line gene therapy are to be considered unpatentable. Also to be considered as
unpatentable are 'processes for modi- fying the genetic identity of animals which are likely to
cause them suffering or physical handicaps without any substantial benefit to man or animal,
and also animals resulting from such processes, whenever the suffering or physical handicaps
inflicted on the animals concerned are disproportionate to the objective pur- sued.' The group
of advisers on the 'ethical impli- cations of biotechnology' of the European Commission has
recently (1995) given cautious approval to the principle of genetic modification of animals. It
is likely that the European Commission will seek a speedy adoption of this directive.
Although there appears to be rather more common ground than heretofore between the
various interest groups involved, it remains to be seen how easy it will be to adopt these
proposals. Of course, even were the pro- posal to be adopted in its present form, not all the
technical and ethical issues relating to patentability in the biotechnological and
pharmaceutical industries will have been resolved. For example, some scientists still maintain
that intellectual property control over aspects of gene technology will inhibit research activity
and could block off whole areas of important scientific research and development; others
respond by pointing out that such a fear applies in respect of the entire patent system, and has
not materialized. The British Technology Group (1996) memorandum states: 'Another
complaint is that if a company has a patent on, say, hepatitis C genes, no one else can do
research in that area. This is incorrect: experimental (research) use of a patented process is
not an infringement. What normally happens is that such research results in an improvement,
which can also be patented. The first company in the field will need the improvement, while
the second company needs to be able to operate under the main (first) patent. The two
normally come to terms by cross-licensing each other under the main and improvement
patents. The system has worked very well, not least in the US which has a flourishing
biotechnology industry.'

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 CONCLUSION

Many of the issues relating to patent and other ownership of human body material, including
genes, have not yet been resolved. There will be continuing uncertainties for some time to
come. Some of the technical uncertainties in connection with patents may well be clarified by
a new European Biotechnology Directive. But many of these technical matters seem to be
inextricably linked to ethical questions. Continuing uncertainty creates difficulties for every-
body, and it is very important that some consensus is established as soon as possible. If any
decision is taken to impose further controls on intellectual property laws, such controls
should be carefully circumscribed so as not to impose unnecessary fetters upon develop-
ments in genetic engineering. Otherwise, exclusions from patentability could lead to wider
constraints which could have very serious effects upon the biotechnology industries, research
and development, and the welfare of us all. In that regard, it is appropriate to notice, and to
welcome, the recent creation in the UK of a Human Genetics Advisory Commission (UK), a
strategic group of eminent independent members, charged with the tasks of keeping under
review scientific progress at the frontiers of human genetics and related fields; reporting on
issues arising from new developments in human genetics that can be expected to have wider
social, ethical and/or economic consequences, for example, in relation to public health,
insurance, patents and employment; and advising on ways to build public confidence in, and
understanding of, the new genetics. There are already bodies of this kind, such as the Nuffield
Council on Bioethics. However, an additional governmental advisory body which will keep
in touch with public views on human genetics and also keep abreast of developments in other
countries, can only be for the good

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 MAJOR FINDINGS

In this project work, the following findings were made:

1.) That ownership of genetic material is extremely crucial for different layers of setups
where such information is required.

2.) That the laws are pertinently complex in this regard. Also there is no compulsion on
the courts everywhere to accept all the results of such tests, unless were ordered by a
competent judicial authority, verifiable by various other members involved.

3.) The issue of there ownership is relevant to the current times and a priority to be acted
upon.

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BIBLIOGRAPHY

Books

1. Assesing Genetic Risks Implications for Health and Social Policy, Lori B. Andrews, Jane
E. Fullarton, Neil A. Holtzman, and Arno G. Motulsky. Washington (DC) National
Academies Press (US); 1994.

2. Science and moral values, Joihn Valrath, University Press of America, 1990.

Journals and Articles

1. American Journal on Medicine, Vol. II, 2016, Michigan University.

2. India‟s Doubting Fathers and Sons Embrace DNA Tests And Ownership, Dr. Anjali
Thomas.

Internet Sources

1. https://india.blogs.nytimes.com/2013/08/16/indias-doubting-fathers-and-
sonsembrace-dna-paternity-tests/
2. https://www.ncbi.nlm.nih.gov/books/NBK236044/

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