Patenting of Life Forms and The Ethical Moral

And Legal Issues: An Analysis

SUBMITTED TO

Dr. Kaumudhi Challa

(Faculty, Jurisprudence-I)

SUBMITTED BY

Vijaya Choudhary

SEMESTER- V

SECTION-A

Roll No.-191

Date Of Submission-21.08.2017

HIDAYATULLAH NATIONAL LAW UNIVERSITY

UPARWARA, NEW RAIPUR (C.G.)
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Declaration

I, Vijaya Choudhary, hereby declare that, the project work entitled, Patenting of Life Forms
and Ethical Moral And Legal Issues: An Analysis submitted to H.N.L.U., Raipur is record of
an original work done by me under the able guidance of Dr. Kaumudhi Challa Faculty,
Hidayatullah National Law University, New Raipur.

Vijaya Choudhary

Semester – V

Section -A

Roll No,-191
 II

Certificate

This is to certify that this project has been made by Vijaya Choudhary on the topic ‘Patenting
of Life Forms and Ethical Moral and Legal Issues: An Analysis’ under the guidance of Dr.
Kaumudhi Challa, faculty of Jurisprudence-I and have completed it successfully.
 III

Acknowledgements

I feel highly elated to work on the topic “Patenting of Life Forms and Ethical Moral And
Legal Issues: An Analysis”.

The practical realization of this project has obligated the assistance of many persons. I
express my deepest regard and gratitude for Dr. Kaumudhi Challa, Faculty of
Jurisprudence-I. Her consistent supervision, constant inspiration and invaluable
guidance have been of immense help in understanding and carrying out the nuances of
the project report.

I would like to thank my family and friends without whose support and encouragement,
this project would not have been a reality.

I take this opportunity to also thank the University and the Vice Chancellor for providing
extensive database resources in the Library and through Internet.

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

Vijaya Choudhary

Semester- V

Section-‘A’

Roll No.-191
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Table of Contents
1. Introduction___________________________________________________________________1
2. Research Methodology__________________________________________________________2
3. Objectives_____________________________________________________________________3
4. Review of theLiterature__________________________________________________________3
5. Hypothesis____________________________________________________________________3
6. Sources of Data_________________________________________________________________4
7. Nature of the Study_____________________________________________________________4
8. Concepts______________________________________________________________________4
9. Chapterization_________________________________________________________________5
10. Time Limitation_________________________________________________________________5
11. Contribution___________________________________________________________________5
12. Scope and Limitation of the Study__________________________________________________6
13. Historical Background____________________________________________________________7
14. Patents on Life-Forms and Living Processes__________________________________________9
15. Patents in Micro-Organisms and its Conceptual Issues_________________________________10
16. Patents on Plants______________________________________________________________13
17. Patents of Transgenic Animals____________________________________________________15
18. Patents on Human Life_________________________________________________________17
19. Conclusion and Suggestions______________________________________________________20
20. References___________________________________________________________________22
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Introduction
Creations of the human brain are called intellect and if they have commercial value they can be
classified as property. Intellectual Property thus refers to inventions, industrial designs for
article, literary and artistic work, symbols, etc. The word patent has been derived from the Latin
word ‘patent-em’ meaning open. The self-contradiction demands an explanation. The widest
possible dissemination of new knowledge makes the greatest economic efficiency. But if
everybody is free to access new knowledge, the inventors have little incentive to commit
resources to produce it. Intellectual Property Rights (IPRs) temporarily transform knowledge
from a public good into a private good so that owners of intellectual property can recoup their
expenditure in creating new knowledge

A patent can be understood as an IPR relating to inventions and is the grant of exclusive right,
for limited period, provided by the Government to the patentee, in exchange of full disclosure of
his invention, for excluding others, from making, using, selling, importing the patented product
or process producing that product for those purposes. Intellectual property is divided into two
main categories: industrial property rights, which include patents, utility models, trademarks,
industrial designs, trade secrets, new varieties of plants and geographical indications; and
copyright and related rights, which relate to literary and artistic works.

To begin with the most obviously contentious subject, should life forms be patentable?
Logically, the answer is straightforward if the criteria as they now stand are followed accurately.
A life form as it occurs in nature is not patentable because there is no inventive step. A captured
life form is also not patentable, because the concept of caging is not novel (though a new and
ingenious design of cage might be). A modified life form is patentable, but only as far as the
actual modification is concerned. This view is intermediate between current patent practice,
which has allowed excessively broad claims on the strength of a limited modification (cotton, for
example), and the vitalist position that nothing to do with life should be patentable. Neither of
these extremes make sense. To think about this wide gap of opinion, it helps to project forward
to the time (probably sometime during this century) when new life forms will be synthesised
from scratch. Such life forms will surely be inventions, and therefore patentable. We shall
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understand them fully, so the mystical element will be gone (incidentally, that's not to say there
should be no sense of wonder at such an accomplishment). Before that point it will be
commonplace to modify life forms so extensively that their origins are unclear. These projections
warn us that appeals to morality to prohibit patenting of life forms will not in the end be
sustainable1 . But that is not to say that the issue is trivial, just that it cannot be dealt with at the
level of patent claims. Conflicts arise because under the current exclusive-rights system
possession of a patent confers too much power. We therefore need to institute stricter controls on
use. Until that has been done, it is better to retain an illogical but precautionary position on
claims.

Research Methodology
Statement of the Problems

 What are the reasons which have been laid down which object to life form patenting?
 What are the Negative impacts of patenting of transgenic animals?
 Why are genes being patented?
 Morality and Patents- Is there a connection?
 What are the reason season for non acceptance of human gene patenting?

Rational of the Study

A life form as it occurs in nature is not patentable because there is no inventive step. A captured
life form is also not patentable, because the concept of caging is not novel (though a new and
ingenious design of cage might be). A modified life form is patentable, but only as far as the
actual modification is concerned.

Objectives
Set in above prospective the major aim of the project is:

 To Study the Historical Background of IPR.

 To Study about the Patents on Life-Forms and Living Processes.
 To Analyze the Patents in Micro-Organisms and its Conceptual Issues.
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 To Elucidate About the Patents on Plants.
 To elucidate about the Patenting of Transgenic Animals.
 To Study About the Patents on Human Life.

Review of the Literature

 A rough set based approach to patent development with the consideration of

resource allocation, Huang Chun-Che et al., Expert Systems with Applications, 38 (3)
(2011) 1980-1992.
 Evergreening: A deceptive device in patent rights, Dwivedi Gaurav, Hallihosur
Sharanabasava and Latha Rangan, Technology in Society, 32 (4) 2(010) 324-330.
 Concerted refusals to license intellectual property rights, Bohannan Christina,
Hovenkamp Herbert J, http://papers.ssrn.com.
 Patenting human genes: The Myriad controversy, Chuang Chester S and Lau Denys
T, Clinical Therapeutics, 32 (12) (2010) 2054.
 Rules for patents, Burstein Michael J, William & Mary Law Review, 52 (6) 2011.
 A uniform framework for patent eligibility, Efthimios Parasidis, Tulane Law Review,
85 (2) (2010).
 A heuristic procedure to identify the most valuable chain of patent priority network,
Fang-Pei Su, Wen-Goang Yang and Kuei-Kuei Lai, Technological Forecasting and
Social Change, http://papers.ssrn.com.

Hypothesis

Patent on life forms means patent for a living entity. As life forms are natural product not the
creation of human therefore in many countries patent is not granted in some countries but there
are some countries where patent on life forms are acceptable.
 4

Sources of Data

The sources of collection of data is Primary and secondary data. This primary and secondary data
has been obtained from published sources such as web sources,articles and other references as
guided by the faculty of Jurisprudence were primarily helpful and of atmost importance in the
successful completion of the project.

Nature of the Study

This project is doctrinal in approach and It analyzes about the Patenting of Life Forms and
Ethical Moral And Legal Issues.

Concepts

 Patent-The exclusive right granted by a government to an inventor to manufacture, use,

or sell an invention for a certain number of years
 Life Forms-the form that is characteristic of a particular organism at maturity.
 Ethical-pertaining to or dealing with morals or the principles of morality; pertaining to
right and wrong in conduct.
 Moral-of, relating to, or concerned with the principles or rules of right conduct or the
distinction between right and wrong;
 Legal-appointed, established, or authorized by law; deriving authority from la
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Chapterization
The focus of the ‘Separate state movements in India’ is on the following topics

 First Section of this study deals with the Historical Background of India and TRIPS
(Related Aspects of Intellectual Property Rights) and Patents Act, 1970 and TRIPS
Agreement.
 Second Section elucidate the Patents on life-forms and living processes and the Indian
Stand on Patenting of Life Forms.
 Third Section Elucidates Patents in Micro-Organisms and its conceptual issues
 Fourth Section of this study deals with the Patents on plants and its Conceptual Issues
and the reasons which object to life form patenting.
 Fifth Section elucidate the Patenting of Transgenic Animals and its Negative impacts of
patenting of transgenic animals
 Sixth Section Deals with the study of Patenting of Human Life and the Reason for non
acceptance of human gene patenting and also the Connection between Morality snd
Patents.

Time Limitation
The time limit taken to complete the project was 3 weeks.

Contribution
Patenting life forms bring with them overbearing issues of religious and ethical values. In
today’s competitive and globalized world, biotechnology revolution is affecting industry
and growth in a big way. It would, thus, be in our national interest to document, protect
and modify new microorganisms isolated from various parts of our country and find their
new and improved industrial uses
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Scope and Limitation of the Study
The scope of These Patenting of Life Forms And Ethical Moral And Legal Issues: An
Analysis is limited within the Indian and world Context which Deals with the Patents on
Life Forms And Living Processes, The Patents in Micro Organisms and its Conceptual
Issues, Patenting on Plants, Transgenic nimals and Human Life.
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Historical Background

India and TRIPS (Related Aspects of Intellectual Property Rights)

On 16 April 1994, India signed the General Agreement on Trade and Tariff (GATT) along with
116 other nation1s. The agreement also established the World Trade Organisation WTO) which
succeeded GATT .Under WTO, no country has the option to choose what part that it likes and
abstain from others2. The Trade Related Aspects of Intellectual Property Rights (TRIPS)
Agreement of WTO imposes a number of rules on member countries. The TRIPS agreement
ensures that patent protection is available for all the fields of technology including agriculture,
energy and healthcare. Also, members can exclude certain inventions from patentability if the
exploitation of the invention would be affecting the morality of general public. TRIPS further
focussed on patentable subject matter in relation to biological materials3.
For example :
(1) Plants, animals, essential biological process of production of plants and animals may be
excluded from patenting.
(2) Microorganisms per se and non-biological and microbiological processes are patentable.

Patents Act, 1970 and TRIPS Agreement

The Patent System in India is governed by the Patents Act, 1970 (No. 39 of 1970) as amended by
the Patents (Amendment) Act, 2005 and the Patents Rules, 2003, as amended by the Patents
(Amendment) Rules 2006 effective from 5 May 2006. The same is in accordance with the
provisions of the TRIPS Agreement. The recent conferment of 'product patent' along with the
'process patent' is an example of such compatibility4. The TRIPS Agreement was formulated to
bring basic level harmonisation in IPRs laws all over the world. The provisions of TRIPS

1 1867 UNTS 187; 33 ILM 1153 (1994).

2 1867 U.N.T.S. 187
3 1869 UNTS 299; 33 ILM 1197 (1994).
4 he Patents Act, 1970 (as amended up to Patents (Amendment) Act, 2005) ... Patents (Amendment) Act, 2005 (Act
No. 15 of 2005) (IN018)
 8

Agreement are the most extensive and rigorous in nature. They protect all the forms of IPRs
collectively5.

5 : 1869 UNTS 299; 33 ILM 1197 (1994)

 9

Patents on life-forms and living processes

Patenting of Life Forms-The Indian Stand

In India before 2002, amendment the understanding is that there is no patent protection for
invention relating to life forms. But in Dimminaco A.G v. Controller of patent and design, the
Calcutta High Court held that a process for preparation of vaccine containing live virus is
patentable since the term "manufacture" covers even living organism. So according to the Court
even if the end product contains a live virus the process involved in bringing out the end product
becomes an invention. It may be noted that there is no decision reported till date directly on the
application of the inventive step standards to inventions relating to biotech patents in India6.

In the light of Article 27 of TRIPS the Section 3 of Patent Act, 1970 has been amended. The
definition of "invention," "new invention," "inventive step" reflects restrictive approach to the
legal protection of living materials. In the absence of definition for "plant," "animal," "micro
organism" "essentially biological process," "non-biological process" and "plant variety" its
interpretation by the patent office becomes crucial7. Since the term micro-organism can have a
variety of definition which may not be exhaustive to include genetic material, it is argued that it
is safer to place reliance upon the guiding provision in TRIPS agreement.

Another concern is that if the "inventive step" is going to be interpret by considering only
technical advance or economic significance, then standard of patentability gets lowered and the
same should not be allowed. Because these factors has been used as secondary considerations
and they never served as a basis for establishing "inventive step."

The 2008, patent manual incorporates provisions which is used as a guidance by the patent office
to interpret various provisions in the Act. Standing Problem,Distance, Surprising Effect, Long
Felt Need, Failure of Others, Complexity of Work, Commercial Success, Cheaper and more
economical Product and simplicity of the proposed technological solution are considered as
indicators of inventive step in 2008 draft Manual of Patent Practice and Procedure.

6 Court of Calcutta dated 15.01.2002 IPLR 2002 July. 255

7 : 1869 UNTS 299; 33 ILM 1197 (1994)
 10

Patents in Micro-Organisms and its conceptual

issues

Can microorganisms, for instance, be patented? Prior to 1980 the answer to this question was:
NO. Microorganisms were clearly "products of nature" and as such were not considered
patentable. However, the era of maneuvering DNA between organisms changed that.
The Mashelkar committee report has clearly stated that microorganisms are patentable subject
matter in India8. Inventions pertaining to Microorganisms and other Biological material were
subjected to product patent in India, unlike many developed countries. But with effect from
20.05.2003 India has started granting patents in respect of invention related to microorganisms,
though India was not obliged to introduce laws for patenting microorganisms per se before
31.12.2004. Microorganisms patenting per se being considered to be a product patent, the period
of protection was 5 years from the date of grant or, 7 years from the date of filing of application
for patent. Now grant of patents for microbiological inventions is for a period of 20 years from
the date of filing.

The most vital and important distinction between the legal practices of the India and developed
countries is that India (developing countries) does not allow patenting of microorganisms that
already exist in nature as the same is considered to be a discovery as per the provisions of the
section 3(d) and therefore not patentable. But genetically modified versions of the same
microorganisms that result in enhancement of its known efficacies are patentable. The grants of
Patent in respect of Microorganisms depend upon the regulations concerning the requirements
for the deposition of Microorganisms under the Budapest Treaty of which India has become a
member, and accessibility of that microorganism from the depositories. As per proviso (ii) to
section 10(d) the Microorganism if not being described fully and particularly and is not

8 www.who.int/intellectualproperty/background/members/mashelkar/en/
 11
availablto public, the said Microorganism is to be deposited before the International Depositary
Authority under the Budapest Treaty9.

Conceptual issues
India has allowed patenting of microorganisms but the Patent Act does not provide a definition
of the term "Microorganisms". This has led to many debates regarding patentability of
microbes. In the absence of clear definition of microorganism and microbiological process in the
TRIPS agreement, the country needs to draw a distinctive line between the product of human
intervention leading to novelty and those freely occurring in nature.

Dimminaco case: a case in the point: Although the Indian Patent Act, 1970 does not permit
patenting of microorganisms, per se, this particular case at Calcutta High Court is a case to
understand the intricacies of patenting. Dimminaco Case 2 clarified the position relating to
patentability of biotechnology inventions, particularly in a case where a process of manufacture
of vaccine involving a living end product was involved.

The main issue in contention between the parties was whether the phrase ‘method of
manufacture’ used in section 2(1) (j) could be said to include a live organism. The court, in its
positive affirmation, has held that the dictionary meaning of ‘manufacture’ did not exclude from
its purview the process of preparing a vendible commodity that contains a living organism10.

The application of microorganisms in food is a million dollar industry today. Since genetically
modified microorganisms (a criteria that lends the human intervention angle to satisfy one of the
criteria to make the organism patentable) is not permitted to be used in the food industry, the
only source for improving the textural and sensory properties of food is by isolation of new
strains of bacteria that deliver these properties. One need not mention the time, effort and money
involved in this excercise. In the Dairy industry, lactic cultures are used for the preparation of
fermented products and cheese whose consumption rates are increasing at a rate of 10%

9 [1987] ATS 9 / 32 UST 1241 / 1861 UNTS 361.

10 Court of Calcutta dated 15.01.2002 IPLR 2002 July. 255
 12
annually. Suppressing the growth of these fermented products is the growth of functional foods
containing probiotic cultures. These are bacteria that when consumed in sufficient quantities
confer some beneficial attributes to the host. The probiotic strains used in these products have
been isolated after decades of research work followed by clinical trials to prove their probiotic
attributes. Most of these strains are patented in the European Union and the United States (where
isolation of a new strain of bacteria is patentable). As a result, these companies are marketing
these products containing these microorganisms.

However, the same protection for these bacteria is not available in India. This is not
encouraging enough for the academia and industry in India to isolate potential probiotic strains
due to the absence of patent protection. Some of the probiotic products launched in India are by
companies which use strains that are catalogued by leading internationalculture suppliers or by
foreign companies that have these strains. One may also run the risk of being accused by other
nations of being insensitive to the issues of promoting multilateral trade and hence of being
subjected to sanctions which may prove to be more economically ruinous in the long run.
 13
Patents on plants
Article 27 (3)(b) of TRIPs agreement allows members to exclude from patent protection, plants
and animals; and biological processes for the production of plants or animals. TRIPs provide
option to member states protecting new plant variety by means of patent or sui generis system or
both. India opted for sui generis protection and legislated “Plant Varieties Protection and
Farmers Right Act-2000” that enables the farmer to save, use, sow, re-sow, exchange, or share
the seeds of protected variety, besides offering protection on farmers' variety, extant variety and
essentially derived variety11.

Conceptual issues

Whereas plant variety protection could boost research in the area of plant biotechnology by both
public and private bodies, it could also result in higher prices for seeds, thus naturally excluding
the small and marginal farmers from accessing such new technologies.

Farmers and indigenous peoples in developing countries such as India are facing serious
problems as plants that they developed and conserved are being 'appropriated” by private entities
leading to bio-piracy and exploitation of traditional knowledge claiming the exclusive right to
produce and sell many 'modified' plants and animals. This is a great matter of concern today that
knowledge, innovation and efforts of these communities are neither acknowledged nor benefited
when the legal 'intellectual property rights' systems grant patents on genetic and biological
materials and on living organisms to private corporations.

The following are the other reasons which have been laid down which object to life form
patenting:

 Farmers would be obliged to pay royalties on every generation of plants and livestock
they buy and reproduce for production purposes.
 Breeders will no longer have free access to germ plasm for developing new varieties of
plants and animals.

11 Article 27 (3)(b) TRIPs agreement.

 14
 Consumers will end up paying high prices for food, medicine and other biotechnological
products.
 In the end, public research which is paid for by all will be privatized by a few.
 Food supply will be threatened by monopolistic control over genetic resources.
 The concept of Human rights will be threatened as human beings, and parts of their bodies
will become the exclusive property of the patent holders.

In 2000,CSIR found that almost 80 per cent of the 4,896 references to individual plant based
medicinal patents in the United States Patents Office that year related to just seven
medicinal plants of Indian origin. Three years later, there were almost 15,000 patents on such
medicines spread over the United States, UK, and other registers of patent offices. In 2005 this
number had grown to 35,000, which clearly demonstrates the interest of developed world in the
knowledge of the developing countries. Whilst the corporations stand to make huge revenues
from this process, the local communities are unrewarded and in fact face the threat in future of
having to buy the products of these companies at high price12.

Hence such system of IPR only benefits the private industries or multi-national corporations of
industrially developed countries at the expense of the developing countries.

Some examples

In Texas, a company called Rice Tec took out the patents on Basmati rice (which grows in the
Indian and Pakistan regions) and have created a genetically modified Basmati rice, while selling
it as normal Basmati -- and it was not against the law, either. In fact, four of the patents were
withdrawn in June 2000, when the Indian government formally challenged the patent.

A US Patent Authority ruling did manage to prevent another company from using turmeric to
create bi-products because there intentions were not novel and turmeric had been around for a
long time. They also canceled a patent on the Ayahuasca plant, a sacred plant for many
indigenous people in Latin America.

12 https://www.ncbi.nlm.nih.gov › NCBI › Literature › PubMed Central (PM

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Patenting of Transgenic Animals

In 1988, a Harvard University biologist was granted a patent for a mouse that had been
engineered for increased susceptibility to cancer. The “Harvard Oncomouse” became the first
animal to be considered an invention by the U.S. Patent and Trademark Office. It established a
precedent within patent procedures for patenting genetically modified animals. Although this
research was intended to benefit human health, the question remains about the ethics of patenting
complex living beings.

By 1997, over forty animals had been patented, including turkeys, nematodes, mice and rabbits.
Hundreds of other patents are currently awaiting approval, including patents on pigs, cows, fish,
sheep and monkeys.

Tracey the sheep has had human genes introduced into her mammary glands so that she produces
a human blood-clotting agent called alpha-1-antitrypsin in her milk. The patent is held by
Pharmaceutical Proteins Ltd. (PPL). Their spokesperson described sheep like Tracey as "furry
little factories walking around in fields." Tracey's success was said to provide "a strong impetus
to the further exploitation of transgenic sheep as bioreactors for the production of large amounts
of pharmacologically active proteins"

PPL have also applied for a broad patent covering all cloned mammals. Dolly the sheep was the
first mammal to be successfully cloned, in February 1997: a nucleus taken from a cell from the
udder of an adult sheep was implanted into an egg which had had its own nucleus removed. This
egg was then transferred into another sheep, where it developed into Dolly, who is genetically
identical to the sheep from which the udder cells were taken. The Scottish research team who
cloned her applied for a broad patent which would give them exclusive patent rights over all
cloned animals.
 16
Negative impacts of patenting of transgenic animals

The major concern that arises out of patenting of transgenic animals are that transferring genes
from one species to another transgresses the natural barriers between them and affects the
11integrity of species. Species belonging to the same group, though they may slightly vary from
one region to the other based on the environmental conditions, they primarily have the same gene
pool. By allowing patenting of transgenic animals, the fundamental genetic architecture is
being tampered with.

Ethical Issues

A number of ethical issues stem from the patenting of animals. Most of them deal with
theconsequences that could arise subsequent to patenting of animals while the other arguments
focus on the religious, philosophical and spiritual grounds. The arguments which go against the
patenting of animals are difficult to prove as many of them are factual assertions which are still
to occur or to be proven. The DNA is considered to be intimately related to the species identity
and hence no part of it should be controlled for commercial interest. In case of human beings,
human DNA is unique and hence possesses intrinsic value of a sacred kind. It can also be put as
‘Human DNA bears the image of God’ and to tamper with them and own them for commercial
and economic interests would hurt the sentiments of the many. The view that plants, animals and
microorganisms comprising life on earth are part of the natural world into which we are born and
hence the conversion of these species, their molecules, or parts into corporate property through
patent monopolies is counter to the interest of the people of the country and world, has been
taken by many.
 17
Patents on human life
A most alarming aspect of patenting life is the patenting of human genes, cell lines and tissues.
Corporate patent attorneys have lobbied the Patent office that these “products of nature” are
patentable once they have been isolated to produce a form not found outside of a laboratory. For
example, in 1976 a leukemia patient named John Moore had surgery at the University of
California to remove his cancerous spleen. The University was later granted a patent for a cell
line called “Mo,” removed from the spleen, which could be used for producing valuable proteins.
The long term commercial value of the cell line was estimated at over one billion dollars. Mr.
Moore demanded the return of the cells and control over his body parts, but the California
Supreme Court decided that he was not entitled to any rights to his own cells after they had been
removed from his body.

Patenting of Genes-

Our Genes define us, as a species as well as individuals, and hence for human genes there are
strong oppositions both on the religious and secular front. Patents are being granted to genes
despite there being many arguments for keeping the genes in the public domain. A patent cannot
be granted on a gene as it naturally occurs. Isolation of the gene is required for it to be
patentable. The patent offices have treated genes as a new chemical compound and have granted
“composition of matter” patents. Thus a patent granted on an isolated and purified DNA
composition confers the right to exclude others from any method of using that DNA composition
for upto 20 years from the date of filing. However Human Beings are not patentable as human
multicellular living organisms are not a patentable13.

Why are genes being patented-Genes have been used for gene therapy though it is still in the
early developmental stages. The technology used in each gene therapy will have huge
commercial value in the coming future making patenting crucial. However gene therapy is not a
patentable subject matter in India14.

13 Https//ghr.nim.nih.gov
14 www.sciencedirect.com
 18

Morality and Patents- Is there a connection?

Patents on living organisms are morally objectionable to many. Patenting organisms and their
DNA promotes the concept that life is a commodity and the view that living beings are “gene
machines” to be exploited for profit. If it is possible to consider a modified animal an invention,
are patents and marketing of human reproductive cells far behind? Patents derive from concepts
of individual innovation and ownership, which may be foreign to cultures which emphasize the
sharing of community resources and the free exchange of seeds and knowledge.

Reason for non acceptance of human gene patenting

Patents on living organisms are morally objectionable to many people. Patenting organisms and
their DNA promotes the concept that life is a commodity and the view that living being are "gene
machines" to be exploited for profit. If it is possible to consider a modified animal an invention,
are patents and human reproductive cells and their marketing far behind? Patents derive from
concepts of individual innovation and ownership, which may be foreign to cultures which
emphasize the sharing of community resources and the free exchange of seeds and knowledge.
Many disputes involving patent infringement cases emerged because of question related to
obviousness, enablement or the priority of invention that had to be decided by the courts. More
difficult were the questions about the ownership rights and privileges. For example, in the patent
'Unique T-lymphocyte line and products derived therefrom', the inventors used the spleen of a
patient Mr. John Moore who suffered from hairy cell leukemia and came for treatment to Dr.
David Golde at UCLA. As part of the treatment, his spleen was removed and Dr. Golde
developed a cell line with enriched T-lymphocytes that produced large amounts of lymphocytes
useful for cancer or AIDS treatment. Without Mr. Moore's initial knowledge or consent, but
requiring his repeated visits to the hospital, Dr. Golde and the University of California applied
for a patent on the cell line derived from Mr. Moore's spleen which was granted in 1984. Mr.
Moore subsequently sued Dr. Golde and the University supreme Court. Both the Appeals Court
and the Supreme Court recognized the novelty of Mr. Moore's claim Mr. Moore on the issue of
conversion (unauthorized use of his body part), but recognized his right to be informed of what
the physician was doing involving his health and well being. It's as irony that a person is not
 19
given any benefit of the substance which he himself had produced, and at the same time others
are minting money from the same substance.

What they say who are in favour:

That without patents society won't benefit from revelations about the molecular roots disease.
Moreover the arguments that patenting DNA promotes the view that life is a commodity, cannot
be accepted because it is not that the main aim of the DNA patenting to earn profit or to use it for
someone personal interest, on the contrary the overall aim of the patent system is to promote the
public interest and to provide a fair reward to inventors. The patents system is said to be justified
because it provides an important incentive for the development or new products and technologies
related to healthcare.

One of the most coveted argument which is vociferously put forward against the patenting of life
forms is that the First World patenting of Third World genetic resources represents theft of
community of biological resources. Patents held by the industrialized world on biological
resources from the developing world will serve as a tool for the North to accumulate more wealth
from the already impoverished south. Microorganisms, plants, animals and even the genes of
indigenous people have been patented for the production of pharmaceuticals and other products.
Requiring developing nations to pay royalties to the wealthy industrial nations for products
derived from their own natural resources and innovation in robbery. Moreover the developing
world has never received compensation or recognition for these intellectual and technological
contributions. Patenting life forms will exacerbate this inequality. This "bio-colonialism" will
continue the pattern of a few transnational corporations profiting at the expense of genetic
resources of the third world countries
 20

Conclusion and Suggestions

Patents on life forms hinder research, indigenous economies, and genetic diversity.
No individual, institution or corporation should be able to claim ownership over species or
varieties of living organisms. Nor should they be able to hold patents on organs, cells, genes or
proteins, whether naturally occurring, genetically altered or otherwise modified. Our reasons are:

Patenting of life forms should be considered unethical because:

 It fosters biopiracy of indigenous resources
 Turns life forms into commodities to be used for profit
 Hinders the free-flow of scientific research
 Destroys economic sustainability of developing nations

 Patents make important products more expensive and less accessible. The biotech
industry claims that patents are necessary so that innovative, life-saving technologies will
be developed. In actuality, patents enable companies to create a monopoly on a product,
permitting artificially high pricing. As a result, products such as drugs are often priced
out of reach for many of those who need them.

 Patents in science promote secrecy and hinder the exchange of information. By patenting
products of research, the free flow of ideas and information necessary for cooperative
scientific efforts is reduced. Scientific materials required for research will become more
expensive and difficult to purchase if one corporation owns the rights to the material.

 Patents exploit taxpayer-funded research. The development of biotechnology rests on 50

years of federally funded biomedical research. Corporations can make profits on their
patented products by charging high prices to the citizens whose tax dollars supported the
research and development of the products. Citizens are unfairly being asked to pay twice
for medicines and other products.
 21

 Patents promote unsustainable and inequitable agricultural policies. A disastrous decline

in genetic diversity could be the result of patenting of crop species. The genetic diversity
inherent in living systems makes patent claims difficult to defend. The development of
genetically uniform organisms would make it easier for corporations to maintain their
patent claims. Biotech companies holding broad spectrum patents on food crops will lure
farmers to grow modified varieties with promises of greater yields and disease resistance.
However, numerous examples worldwide show the “improved” crops have failed to hold
up to corporate promises, and led to the loss of the rich diversity of traditional crop
varieties.

 First World patenting of Third World genetic resources represents theft of community
resources. Patents held by the industrialized world on resources from the developing
world will serve as a tool for the North to accumulate more wealth from the already
economically impoverished South. Microorganisms, plants, animals and even the genes
of indigenous people have been patented for the production of pharmaceuticals and other
products. Requiring developing nations to pay royalties to the wealthy industrial nations
for products derived from their own natural resources and innovation is robbery.

 Patenting life forms bring with them overbearing issues of religious and ethical values. In
today’s competitive and globalized world, biotechnology revolution is affecting industry
and growth in a big way. It would, thus, be in our national interest to document, protect
and modify new microorganisms isolated from various parts of our country and find their
new and improved industrial uses. However, in the clash between socialist and capitalist
centric ideologies, the betterment of the society as the prime objective should be borne in
mind before our regulatory bodies arrive at a conclusion.
 22

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