Unit-1: INTRODUCTION to IPR

Man has created his own world by application of his brain or mind and by utilization
of natural resources. Man has also been bestowed with imagination and creativity. With his
imagination and creativity, he has been producing various articles or products for his needs,
comfort and convenience. In the earlier era, the creations and inventions by him fell in a
public domain. These were the common properties. Anybody could use and copy these
creations and inventions without any restriction, reservation or payment. However, with the
passage of time, the importance and value of these creations was realized. The commercial
aspect started playing a significant role in these creations. By end of Twentieth Century, the
things created and invented by the human mind were recognized as an intellectual property
of the owner. The owner’s right over these properties was accepted and is known as an
Intellectual Property Right (commonly called I.P.R.). A new set of laws called Intellectual
Property Right Laws, were enacted to protect these property rights. These I.P.R. laws
provided a protection to the owners under different categories and names like Patents,
Industrial designs, Copyrights, Trade- Marks etc.

Intellectual Property (IP)

The capability of the brain to think and imagine something innovative or novel is
known as ‘intellect’. When someone possesses such an intellect, which can be used to invent
something for the benefit of the society/masses, then the invention becomes his property, for
which he can possess all the rights to use it the way he likes.
Eg: idea, business method, invention etc.

Intellectual Property Rights (IPR)

As the name indicates Intellectual Property Rights are exclusive rights over the creations of
the mind. A creator can have exclusive rights over his creation for a certain period of time
depending upon the type of Intellectual Property.

Significance of Intellectual Property Rights

The intellectual property rights were essentially recognized and accepted all over the world
due to some very important reasons. Some of the reasons for accepting these rights are:-
a). To provide incentive to the individual for new creations.
b). providing due recognition to the creators and inventors.
c). Ensuring material reward for intellectual property.
d). Ensuring the availability of the genuine and original products

Introduction to different forms of IPR

To completely protect Intellectual Property (IP) generated in various fields, IPRs are divided
into the following forms:
! Copyright
! Trademarks
! Patent
! Trade secrets
! Geographical indication
! Industrial design
! Plant breeder rights
! Traditional Knowledge

1. Copyright

Copyright is a right given by the law to creators of literary, dramatic, musical and artistic
works and producers of cinematograph films and sound recordings.

Rights under copyright can be divided into two types:

Economic rights: These allow the owner to have financial benefits from the use of his/her
IP. The economic rights can always be transferred by the owner to other individual or an
organization.

Moral rights: These rights always remain with the owner even if the economic rights have
been transferred. Using moral rights, the owner can object to his work (to which economic
rights have already been lost), which is being used in a way that may harm reputation of the
owner.

Subject matter of copyright :

Copyright subsists throughout India in the following classes of works:

! Original literary, dramatic, musical and artistic works;

! Cinematograph films; and
! Sound recordings.

A literary work includes-

" Prose (Novels, Biography, Story, Folktales, Books)

" Poetry (Poems)
" Drama
" Computer software (Databases, application softwares, operating systems, vedio
games, etc)

An artistic work means-

! a painting, a sculpture, a drawing (including a diagram, map, chart or plan), an

engraving or a photograph, whether or not any such work possesses artistic
quality;
! a work of architecture; and
! any other work of artistic craftsmanship.

In biotechnology, the copyright may cover DNA sequences data that may be published.
However, an alternative sequence coding for same protein may be prepared using wobble in
the genetic code, so that the copyright is not infringed.

Rights of authors
Copyright means the exclusive right ·

• To reproduce the work

• To issue copies of the work to the public ·
• To perform the work in public ·
• To communicate the work to the public. ·
• To make cinematograph film or sound recording in respect of the work ·
• To make any translation of the work ·
• To make any adaptation of the work.

Term of Copyright

• The general rule is that copyright lasts for 60 years.

• In the case of original literary, dramatic, musical and artistic works the 60-year period
is counted from the year following the death of the author.

• In the case of cinematograph films, sound recordings, photographs, posthumous

publications, anonymous and pseudonymous publications, works of government and
works of international organizations, the 60-year period is counted from the date of
publication.
The Copyright Office is currently located at the following address:

Boudhik Sampada Bhawan, Plot No. 32, Sector 14, Dwarka, New Delhi-110078
Telephone No.: 011-28032496, 08929474194

2. Trademarks
The trademark or service mark is a sign or indicator that is used to distinguish products or
services provided by any individual or a business organization from their competitors. In
short, a trademark is a “brand name”. A trademark can be one of a word, a phrase, a logo, a
symbol, a design, a sound mark, a smell or a combination of any of these, which identifies the
source of products or services.

Service marks: A service mark is any word, name, symbol or device (or any combination
thereof) that identifies and distinguishes the services of one party from those of others.
Service marks are often referred to as trademarks for convenience or because certain
jurisdictions may not recognize the term service.

“Service” means service of any description which is made available to potential users and
includes the provision of services in connection with business of any industrial or commercial
matters such as banking, communication, education, financing, insurance, chit funds, real
estate, transport, storage, material treatment, processing, supply of electrical or other energy,
boarding, lodging, entertainment, amusement, construction, repair, conveying of news or
information and advertising.

The two main characteristics for a trademark to be granted are that it should be distinct (non
descriptive) and it should not be deceptive. The trademark should not be a generic name for a
product or service. For example, the word apple cannot be a trademark of an organization
which is growing/distributing apples but it can be a trademark of an organization which
manufactures computers. Additionally, the trademark should not potentially mislead someone
about certain characteristics of a product or service. For example, using phrase like “pure
wool” or “fresh juice” as a trademark may mislead about the characteristics of wool and
juice.

The function of a Trade mark

Under modern business condition a trade mark performs five functions

# It identifies the goods / or services and its origin.

# It guarantees its unchanged quality

# It advertises the goods/services

# It creates an image for the goods/ services.

# It stimulates further purchase

A
Trademarks can be categorized as having the following levels of distinctiveness or
strength:

Fanciful or coined marks: These marks are words that are made up and have no meaning
other than as a brand name (e.g., XEROX for copiers and EXXON for petroleum products).
Such marks generally receive the broadest scope of protection.

Arbitrary marks: These marks include words that may have a common meaning but not in
relation to the goods or services for which they are used as brand names (e.g., APPLE for
computers and SAMSUNG for televisions).

Suggestive marks: These marks suggest some attribute or benefit of the goods or services,
but do not describe the goods themselves (e.g., MICROSOFT for software for
microcomputers, AIRBUS for airplanes, and VOLKSWAGEN for automobiles).

Descriptive marks: In most countries, terms that describe goods, services or their
characteristics cannot be protected as a mark unless the public has come to recognize them as
marks, in which case, the term is said to have “acquired distinctiveness” or “secondary
meaning.” Terms can acquire distinctiveness through extensive use and advertising (e.g.,
RICH „N CHIPS for chocolate chip cookies and HOMEMAKERS for housekeeping
services).

Certification marks

The state enforced certification marks presently in India are:

! ISI mark. For industrial product. Certifies that a product conforms to a set of
standards laid by the Bureau of Indian Standards.

! FPO mark. A mandatory mark for all processed fruit products in India. Certifies
that the product was manufactured in a hygienic 'food-safe' environment.

! Agmark for all agricultural products.

! The Non Polluting Vehicle mark on motor vehicles certifying conformity to the
Bharat Stage emission standards.

! BIS hallmark. Certifies the purity of gold jewellery.

 The official website

Term of Trademark

Once the trademark is registered, it is valid for a period of 10 years from the date of
application. The registration can then be renewed indefinitely as long as the renewal fees are
paid every 10 years.
 3. Trade secrets
Trade secret may be a formula, practice, process, design, pattern or compilation of
information used by an organization to get an advantage over their competitors.

• The trade secret may not be protected by a patent because it is a part of the expertise
of people skilled in the art which may loose its economic value after its availability to
public.

• Trade secrets are not awarded any official protection secrets since they are not
disclosed.

• However, stealing of trade secrets amounts to unfair practices and is punishable under
law.

• To protect the trade secret, the organization should get an agreement signed with all
of its employees to prevent these unfair practices.

• However, if a competitor discovers about a trade secret by using reverse engineering

then original owner will not be able to sue the competitor.

Few examples of trade secrets include

• recipe of a cold drink,

• a company’s accounting practice,
• customer specific data available with a company.
 4. Geographical indication
When goods or services have some qualities or certain reputation that are by virtue of its
geographical origin or location, then they are named or signed by a geographical indication,
which indicates its location.

For example, recently pashmina shawls were granted GI because pashmina refers to a type of
fine kashmiri wool and the textiles made from it. The most famous examples of geographical
indications are champagne, and scotch.
Deputy Registrar of Geographical Indications
Intellectual Property Office Building,
G.S.T Road, Guindy, Chennai – 600 032.
Phone: 044- 22502092 Email: gir-ipo@nic.in, cgnaidu.ipo@nic.in
 5. Plant variety protection
Although the rank of species is an important botanical classification, it is clear that the plants
within a species can be very different. Farmers and growers need plants which are adapted to
the environment in which they are grown and which are suited to the cultivation practices
employed. Therefore, farmers and growers use a more precisely defined group of plants,
selected from within a species, called a "plant variety". A variety must be recognizable by its
characteristics, recognizably different from any other variety and remain unchanged through
the process of propagation.

"Plant breeder is defined as the person who bred, or discovered and developed, a variety.

Need for Protection of Plant Varieties

World population continues to grow and it is necessary to find ways of increasing output
through higher yields and less wastage, thereby minimizing the use of land and other
resources, all of which are becoming more scarce.

The simple objective of a breeder is to produce a variety which is an improvement on the

plants used as the starting point. However, this is a difficult challenge. Many useful
characteristics, such as yield and quality, are controlled by the interaction of very large
numbers of genes, about most of which little is known. Very large numbers of plants must be
examined by the plant breeder over many different seasons and under different growing
conditions. Once a desirable plant has been identified, it is still necessary to fix its genetic
structure in order that it can be multiplied into a variety, the individual plants of which
perform in the desired way. Thus, the breeding of a plant variety takes place over many years.

Large-scale breeding work calls for significant annual investment in land, specialized
equipment (including, for example, greenhouses, growth chambers and laboratories), and
skilled scientific manpower, which must continue over the many years which it takes to find
and develop an improved plant variety. Not all plant breeders are successful and, even where
successful, changes in market requirements may eliminate the possibility of a return on
investment, so there is also risk involved. However, the benefits arising from the
combinations of increased output and improved quality made possible by plant breeding are
such that society has good reasons to encourage investment and risk-taking in this field. In
addition, breeding programs for ornamental plants can be of substantial economic importance
for an exporting country. The breeding and exploitation of new varieties is a decisive factor
in improving rural income and overall economic development. Furthermore, the
development of breeding programs for certain species can remove the threat to the survival of
the species in the wild.

India initiated its legislative process to protect plant varieties. Although all the three options-
patent, sui generis, and patent and a sui generis-were available, India chose a sui generis
system for protection of plant varieties. An act named as ‘Protection of Plant Variety and
Farmer’s Rights (PPVFR)’, 2001 has been passed.
Conditions/Criteria for the grant of the breeder’s right
A variety shall be granted protection if it is:
1) Novelty;
2) Distinctness;
3) Uniformity; and
4) Stability.
5) It must also be given a suitable denomination.

Farmer’s Rights (FR)

Farmer shall be entitled to produce, save, use, sow, re sow, exchange, share or sell his farm
produce including seed of a variety protected under this Act. However, this right to sell the
seed does not cover the branded seed of a protected variety. Branded seed means any seed
placed in a package or any other container and labeled to indicate that such seed is that of a
protected variety.

The PPVFR grants right to the breeder to exclude others from producing, offering for sale,
selling, marketing, distributing, exporting or importing the propagating material of the variety
for a period of 15 years in the case of annuals and 18 years in the case of vines and trees.

6. Industrial design
• A Design refers to the features of shape, configuration, pattern, ornamentation or
composition of lines or colours applied to any article, whether in two or three
dimensional(or both) forms.
• This may be applied by any industrial process which in the finished article appeals to
and judged solely by the eye.
• The main objective of protecting industrial design is to improve usability and
commercial value of mass-produced products.
• Examples of industrial designs include watch designs, jewel designs, automobile
designs, textile designs, designs of household articles, electrical equipment and
architectural structures.
• To obtain the industrial design protection, the design must be new or original and the
design should be reproducible by industrial means.
 The official website

7. Traditional Knowledge
What is Traditional Knowledge?

Traditional knowledge or “TK” may be considered as: knowledge, know how, skills,
innovations or practices; that are passed between generations; in a traditional context; and
that form part of the traditional lifestyle of indigenous and local communities who act as their
guardian or custodian.

It can be, for example, agricultural, environmental or medicinal knowledge, or knowledge

associated with genetic resources.

Examples include, among thousands of others:

• knowledge about traditional medicines;

• traditional hunting or fishing techniques;
• knowledge about animal migration patterns;
• knowledge about water management
What are Traditional Cultural Expressions?
TCEs: may be considered as the forms in which traditional culture is expressed;
form part of the identity and heritage of a traditional or indigenous community; are passed
down from generation to generation.
They can be:
• Dances
• Songs
• Handicraft
• Designs
• Ceremonies
• Tales
• or many other artistic or cultural expressions.

Traditional Knowledge Digital Library (TKDL)

• Traditional Knowledge Digital Library - A tool for prevention of misappropriations of
traditional knowledge
• It is a database with a tool to understand the codified knowledge existing for the
Indian Systems of Medicine including Ayurveda, Siddha, Unani and Yoga as prior
art.
• It is not a diagnostic or usage database.
• TKDL contains the scanned images of medicinal formulations from the original
books.
• TKDL covers over two lakh formulations which have been taken from Ayurveda,
Unani, Siddha and Yoga texts.
The information on traditional medicines appears in a standard format in TKDL.
 • Name of the drug
• Origin of the knowledge
• Constituents of the drug with their parts used and their quantity
• Method of preparation of the drug and usage of the drugs
• Bibliographic details
• TKDL, gives modern names to plants (e.g., Curcuma longa for Turmeric), diseases
(e.g., fever for jwar), or processes, mentioned in the literature related to Indian
Systems of Medicine, and establishes relations hip between traditional knowledge
and modern knowledge.

Why TKDL?

It has been observed that in the past years patents have been wrongly granted to
traditional knowledge related inventions which do not fulfill the requirement of
novelty and inventive step, particularly due to existence of relevant prior art.
For examples, this has happened in the case of Turmeric, Neem, Basmati etc.

TKDL breaks the language and format barrier and makes available this information in
English, French, Spanish, German and Japanese in patent application format, which is
easily understandable by patent examiners. TKDL is thus a tool providing defensive
protection to the rich traditional knowledge of India. TKDL acts as a bridge between
formulations existing in local languages and a Patent Examiner at a global level.
 8. Patent
What is a Patent?

A patent is a set of exclusive rights granted by the government of a country to an

inventor (or an assignee) for an invention in exchange of full disclosure of the
invention.

Purposes of Granting Patent

• Inventors usually spend considerable amount of time and resources in conceptualizing

and developing inventions. Therefore, an invention may have a commercial value.
Thus the inventor acquires legal rights over the invention, to obtain
payment/royalties in exchange for use and ownership of the invention by others.
• These exclusive rights empower the inventor to control the manufacture and sale of
the invention and to prevent others from making, using, importing or selling the
invention.
• To promote technological innovation in a country. This in turn helps in industrial
development, thereby increasing the economic growth of the country.
• It facilitates generating new revenue streams through licensing and sale of the
patent.

PATENTABLE SUBJECT MATTER

• 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 improvement thereof, may obtain a patent,” subject to the conditions and
requirements of the law.
• The word “process” is defined by law as a process, act or method, and primarily
includes industrial or technical processes.
• The term “manufacture” refers to articles that 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.
Non-Patentable Inventions in India

" Any invention which is ‘frivolous’ or contrary to well-established natural laws

are non-patentable;
for example, machine that gives more than 100% performance or perpetual machine.

1. Commercial exploitation or primary use of inventions that is contrary to public

order or morality are non-patentable.
For example, gambling machine, device for house-breaking or anything that causes
serious prejudice to health of human, animal, plant life or to the environment are non-
patentable.
For example, biological warfare, material or device, weapons of mass destruction,
terminator gene technology, or embryonic stem cell.

• Mere discovery of a scientific principle or formulation of an abstract theory,

discovery of any living thing or discovery of non-living substance occurring in
nature are non-patentable.
For example, Newton’s laws, superconducting phenomenon as such property of
certain material to withstand mechanical shock, discovery of microorganism,
discovery of natural gas or a mineral.
• Mere discovery of any new property, new use for a known substance or of the
mere use of a known process, machine or apparatus are non-patentable unless
such known process results in a new product or employs at least one new
reactant.
For example, new use of aspirin for heart ailments, mere new uses of Neem
(Azadirachta indica)
• Mere arrangement or re-arrangement or duplication of known devices, each
functioning independently of one another in a known way is non-patentable.
For example, a bucket fitted with torch, an umbrella with fan, a clock and radio in a
single cabinet, a flour-mill provided with sieving.

1. Method of agriculture or horticulture is non-patentable.

For example, method of cultivation of algae, method of vegetative propagation of a
plant or method of preparing an improved soil. However, agricultural equipments are
patentable.
• Any process for medicinal, surgical, curative, Prophylactic, diagnostic,
therapeutic or used for the treatment of human beings or a similar treatment of
animals to render them free of disease or to increase their economic value or that
of their products are non-patentable.
For example, method of removal of cancer/ tumor, removal of dental plaque and
carries surgical processes, processes relating to therapy, method of vaccination and
blood transfusion. However, surgically therapeutic or diagnostic apparatus or
instruments are patentable.
• Plants and animals in whole or any part thereof other than micro-organisms, but
including seeds, varieties and species and essentially biological process for
production or propagation of plants and animals are non-patentable.
For example, clones of animals and plants. However, we have a unique system of
plant protection.
1. A process for production of plants or animals if it consists entirely of natural
phenomena such as crossing or selection (essentially biological process) is non-
patentable.
2. Inventions that are traditional knowledge or an aggregation or duplication of
known properties of traditionally known component or components are non-
patentable.
3. For example, wound healing property of Curcuma longa (haldi), the traditional
knowledge of which is already in public domain. However, any value addition using
traditional knowledge leading to a new process or product, which is novel with
inventive step and industrial applicability like the extraction of ‘Azadirachtin’ from
neem plant, is patentable.
4. Inventions falling within the Atomic Energy are not patentable as a
precautionary measure for national security. “No Patent shall be granted in
respect of an invention relating to atomic energy”.
5. For example, inventions relating to compounds of uranium, beryllium, thorium,
plutonium, radium, graphite, lithium and more as notified by the Central government
from time to time.
Patentable Ingredients of Biotechnology

RNA, DNA or Amino Acid Sequences:

Random isolated sequences generally will not be patentable if they have no utility, i.e.,
they have no known use at the date of filing application. For example, ESTs sequenced
without any function or utility is non-patentable.

DNA & RNA Vectors:

Novel vectors created in lab used for cloning or expressing gene sequences may be
patentable.

Cell Lines:

Artificially produced cell lines are patentable.

Gene:

A gene to which genetic alterations have been made are patentable, a gene in
recombinant form or newly isolated gene in pure form is patentable if its utility or
function is known.

Protein:

Patent protection for a protein may be granted if the protein is not previously
characterized or has been isolated from a natural resource in pure form. A novel or known
protein obtained through RDT may be patentable. For example, hormone expressed from
recombinant vector.

Microorganism:

A new strain of microorganism produced artificially transformed by recombinant vector

is patentable. A microorganism newly isolated in pure form from a natural source is also
patentable. A novel product produced by a microorganism is patentable. If a product
produced by a microorganism is known, the process of producing the product via
microorganism may be patentable.

Molecular Biology Techniques:

Any novel technique( s) or processes for producing a particular molecular biology

product may be patentable.

Plant and Animal:

Plant varieties may be protected in most industrial countries by way of plant variety
rights (also called plant patents). According to plant patents, new asexually reproduced
plants can be protected with certain exceptions and ornamental designs in two different
ways: Plants Breeder’s Right (PBR), and Patents.

CONDITIONS TO BE SATISFIED BY AN INVENTION TO BE PATENTABLE

A patent can be granted for an invention on the following ground:

! Novelty

! Non-obviousness

! Usefulness

Novelty:

A novel invention is one, which has not been disclosed, in the prior art where prior art
means everything that has been published, presented or otherwise disclosed to the public
on the date of patent(The prior art includes document in foreign languages disclosed in
any format in any country of the world).

Novelty is a fundamental requirement for all patents in all the countries, which means that
the invention should not be known to the public before filing the application.

Inventive Step:

For patenting something, it must provide some advancement or step forward in

technology. All elite inventions are said to lack an inventive step if it would be obvious to
a person of general skills apart.

The degree of thought and imagination required to render an invention patentable will
differ. Non-obviousness of patents is considered if the inventor gets an unexpected
outcome from the combination of known prior art elements with their known
characteristics.

For determining and evaluating whether an invention is obvious or not, analysis of a

Person Having Ordinary Skill In The Art (PHOSITA/POSITA) is considered as a
standard.

The PHOSITA is a person considered to have average skills and knowledge in a

particular technical field.

Usefulness:

Usefulness is another requirement to apply for patents. The invention should have some
industrial applicability and provide benefit to the masses.

Deposit of Microorganisms:

It is essential to the need of filing and enabling disclosure. It is necessary as it would be

impossible to accurately describe in writing all the characteristic of the microorganism. A
sample can be deposited in a recognized depository like AICC, MTCC etc. Before going
for the patent, the microorganism has to be deposited so.

If the invention uses a biological material which is new, it is essential to deposit the same
in the International Depository Authority (IDA) prior to the filing of the application in
India in order to supplement the description. The description in the specification should
 contain the name and address of the International Depository Authority and, date and
number of deposition of Biological material. If such biological material is already known,
in such case it is not essential to deposit the same. There is an International Depository
Authority in India located at Chandigarh which is known as Institute of Microbial
Technology (IMTECH).

Classification of Patents in India

Procedure for granting patents

In India, the major steps for granting patents involve

• Filing of an application for patent with complete specification.
• Examination of application by Patent office.
• Advertisement of acceptance of application with complete specification.
• Opposition to grant of patent if any. The opposition can be made at several steps but
before and after the grant, also known as pre-grant and post-grant opposition
respectively.
• Hearing the parties in case of any opposition.
• Grant and sealing of the patent.
A

Term of the Patent

1. The patent is granted for a period of 20 years by the patent office. (according to
TRIPS agreement, amended in 2002)

2. The patent can be renewed or kept alive by paying a renewal fee.

3. Patent grant is given country wise and is effective throughout India.

 International Patent System: PCT (Patent Cooperation Treaty)
The PCT is an international agreement with 148 Contracting Counties. The PCT makes it
possible to seek patent protection for an invention simultaneously in a large number of
countries by filing a single “international” patent application instead of filing several separate
national or regional patent applications. Patent Cooperation Treaty (PCT) is administered by
WIPO. The treaty was signed on 19 June 1970 at Washington, amended on 28 September
1979 and on 3 February 1984. It was further modified on 3 October 2001. The Patent
Cooperation Treaty (PCT) assists applicants in seeking patent protection internationally for
their inventions, helps patent Offices with their patent granting decisions, and facilitates
public access to a wealth of technical information relating to those inventions. By filing one
international patent application under the PCT, applicants can simultaneously seek protection
for an invention in 148 countries throughout the world.

The PCT procedure includes

1. Filing 2. International Search 3. International Publication 4. Supplementary

International Search (optional) 5. International Preliminary Examination (optional)
6. National Phase

The PCT procedure includes:

1. Filing: you file an international application with a national or regional patent Office
or WIPO, complying with the PCT formality requirements, in one language, and you
pay one set of fees.

2. International Search: an “International Searching Authority” (ISA) (one of the

world’s major patent Offices) identifies the published patent documents and technical
literature (“prior art”) which may have an influence on whether your invention is
 patentable, and establishes a written opinion on your invention’s potential
patentability.

3. International Publication: as soon as possible after the expiration of 18 months from

the earliest filing date, the content of your international application is disclosed to the
world.

4. Supplementary International Search (optional): a second ISA identifies, at your

request, published documents which may not have been found by the first ISA which
carried out the main search because of the diversity of prior art in different languages
and different technical fields.

5. International Preliminary Examination (optional): one of the ISAs at your request,

carries out an additional patentability analysis, usually on an amended version of your
application.

6. National Phase: after the end of the PCT procedure, usually at 30 months from the
earliest filing date of your initial application, from which you claim priority, you start
to pursue the grant of your patents directly before the national (or regional) patent
Offices of the countries in which you want to obtain them.

Patenting Of Genetically Modified Organisms

Why are GMO companies granted patents?

The discovery, development, and authorization of a new GMO plant costs $136 million on
average, and companies would not have been willing to make such investment without a
period of exclusivity and profitability granted.

1. Utility and plant patents have a patent term of 20 years from the initial ling, so
GMO patents protect a marketed product for about 15 to 20 years after the time of
product development.

2. For instance, Monsanto’s Roundup Ready soybeans launched in 1996, and US Patent
Nos. 5,352,605 and RE39,247, expired in 2011 and 2014, respectively.

3. After a patent expires, the invention becomes public knowledge to which other
companies, farmers, and other interested parties have free access.

4. At that time, the GMO can be mass-reproduced and the underlying genetic design can
be utilized by anyone to develop improved versions of the GMO.

5. This eventual free access is one way in which GMOs developed by private companies
could bring about public benefit.

What is covered by the GMO patents?

Interestingly, GMO companies often don’t seek plant patents for their plants and seeds.
Instead, they obtain utility patents, a different type of patent with more stringent
requirements on the description of the invention.

Utility patents have several advantages over plant patents.

1. First, utility patents may cover inventions beyond plants. If a GMO involves
integration of novel, foreign DNA into the plant genome, the uniquely designed DNA
can also be protected by utility patents.

2. Second, utility patents provide better protection against infringement.

3. As seen in the Supreme Court case Bowman v. Monsanto, utility patents prohibit the
replanting of seeds harvested from a licensed plant.

4. In contrast, plant patents allow licensees to sexually reproduce indefinitely, as long as

they don’t provide or sell the seeds to others for planting.

5. Therefore, utility patents provide more extensive protection for GMO plants.

The two patents involved in Bowman v. Monsanto are utility patents for DNA sequences.
One relates to engineered genes that allow for robust production of foreign proteins in the
plants. The other covers the gene encoding an enzyme that gives rise to Roundup tolerance.

Gene patents were recently ruled by the Supreme Court as invalid, but GMO companies are
still able to obtain patents on complementary DNA (cDNA), an edited version of the original
gene.

By patenting the cDNA sequence of a gene and its variants, GMO companies can prevent
others from introducing the gene to any other plants without having to obtain individual
patents for each plant.

Under such patent protection, Monsanto generated Roundup-tolerant soy, corn, cotton,
canola, and alfalfa using the same core technology. Other GMO front-runners, such as Bayer
and Syngenta, also predominantly possess utility patents on GMOs.
 IPR related legislation in India
• Patent act in india

The Indian Patents Act 1970

The Patents (Amendment) Act, 1999 came into force on 26 March.

The Patents (Amendment) Act 2002 came into force from 20 May 2003

The Patents (Amendment) Act 2005 effective from 1 January 2005

• TRADEMARK ACT IN INDIA: The Trade Marks Act, 1999 and is the current
governing law related to registered trademarks.

• THE COPYRIGHT ACT IN INDIA: The Copyright Act, 1957 came into effect
from January 1958.

• Industrial designs in India : The registration and protection of industrial designs in

India is administered by the Designs Act , 2000

• Geographical Indications of Goods : India, as a member of the World Trade

Organization (WTO), enacted the Geographical Indications of Goods (Registration &
Protection)Act, 1999 has come into force with effect from 15th September 2003.

• Protection of Plant Varieties and Farmers' Rights : Protection of Plant Varieties

and Farmers' Rights Act, 2001 has been enacted in India.

International Agreements and organizations related IPR

1. General Agreement on Tariffs and Trade (GATT)

2. World Trade Organization (WTO)

3. Trade Related Aspects of Intellectual Property Rights (TRIPS)

4. World Intellectual Property Organization (WIPO)

1. General Agreement on Tariffs and Trade (GATT)

! GATT was signed in 1947, and came into force on

1 January 1948 signed by 23 states.

! It was required after the World War II to revitalize the world trade and encourage the
countries to participate freely.
 ! The purpose of the GATT was the ‘substantial reduction of tariffs and other trade
barriers and the elimination of preferences, on a reciprocal and mutually advantageous
basis’.

! Under the GATT, eight rounds of negotiations took place to liberalize world trade.

! The last round was the Uruguay Round, which was completed on 15 December 1993.

! It is one of the important agencies of the United Nations, which provides better and
wider protection for the private patent holders of the developed nations.

2. World Trade Organization (WTO)

• In 1995, WTO was established, which replaced the GATT.

• WTO intends to supervise and liberalize international trade

• It had 157 members (till 2012) of which 117 are developing countries.

• The headquarters of WTO is at Geneva, Switzerland.

WTO activities

• It helps in promoting peace,

• helps in dispute settlement,
• makes rules that make life easier for all,
• conducts freer trade that cuts the costs of living,
• provides more choice of products and qualities,
• Moreover, the system encourages good government.
• Providing detailed information on biotechnology, genetically modified (GM)
food, and their business
• International trade is beneficial to all the countries and their citizens. It is a fact
that trade leads to growth, which in turn promotes national development and
reduces poverty.

WTO Treaties:

1. General Agreement on Tariffs and Trade (GATT)

2. General Agreement on Trade and Services (GATS)

3. Agreement on Technical Barriers to Trade (TBT)

4. Agreement on Government Procurement (AGP)

5. Agreement on the Application of Sanitary and Phytosanitary Measures (SPS)

6. Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs)

7. Agreement on Trade-Related Investment Measures (STRIMs)

8. Agreement on Agriculture (AOA)

3. Trade Related Aspects of Intellectual Property Rights (TRIPS)

" It is an international agreement between the member nations of World Trade

Organization (WTO).

" TRIPS Agreement is aimed at harmonizing the Intellectual Property (IP) related laws
and regulations worldwide.

" The TRIPS agreement came into force on 1st January, 1995.

" The Agreement covers the following areas of IP:

1. Copyrights and Related rights (i.e. the rights of performers, producers of sound
recordings and broadcasting organizations),

2. Trademarks (including service marks),

3. Geographical Indications (including appellations of origin),

4. Industrial Designs,

5. Patents (including the protection of new varieties of plants),

6. Layout-designs of Integrated Circuits and

7. Undisclosed Information (including Trade Secrets and Test Data)

The Agreement governs the following issues:

1. How basic principles of the trading system and other international IP agreements
should be applied?

2. How to give adequate protection to IPR?

3. How countries should enforce IPR adequately in their own territories?

4. How to settle disputes on IP between members of the WTO?

5. Special transitional arrangements during the period when the new system is being
introduced.

TRIPS agreement and India:

1. India became a party to the TRIPS Agreement in April 1995.

2. The Patent Act of 1970 was in contravention with the Article 27 of the Agreement.
 3. Hence India needed to take some measures to make its IPR laws compliant with the
Agreement.

4. The Agreement provided a framework for developing countries like India which did
not allow product patents in the areas of pharmaceuticals and agricultural chemicals
before the Agreement came into force.

4. World Intellectual Property Organization (WIPO)

$ WIPO an international organization responsible for the promotion

and protection of intellectual property throughout the world.

$ WIPO was established on 14 July 1967, which entered into force in 1970.

$ Headquarters: Geneva, Switzerland

$ Today WIPO is a dynamic entity with 191 member states, i.e. over 90% of the
countries of the world are its members.

$ World Intellectual Property Day – April 26, 2019

$ WIPO Activities

1. It set up the basic standards for the protection of intellectual property rights.

2. The convention allows the granting of the patent for the innovation in technology
including biotechnology, trade promotion among the member countries and

3. protection of industrial property, which includes industrial patents, utility models,

industrial designs, trademarks, indications of source of appellations of origin and
repression of unfair competition.

Biosafety
Biohazard or biological hazard refer to biological substances that pose a threat to the health
of living organisms, primarily that of humans. This can include samples of a microorganism,
virus or toxin that can affect human health.

The Assessment of Risk

! Risk assessment is defined as an estimation of risks in terms of likelihood of

occurrence of hazards and severity of their damages.

! Work with biohazardous agents, needs to be assessed for the risk it poses to the
worker, the community, and the environment.
! A risk assessment should be done to provide the information needed to eliminate a
particular risk OR reduce that risk to an acceptable level.
! A risk assessment should be done before work begins and should be repeated when
changes are to be made in agents, practices, employees, or facilities.
! Biohazardous agents are classified into four risk groups (RGs).
! WHO Classification of Infective Microorganisms by RG (WHO, 2004)
Infective organisms are categorized into four Risk Groups (RGs), reflecting their
relative hazards, based upon factors such as
• pathogenicity,
• infectious dose,
• mode of transmission,
• host range,
• availability of effective preventive measures, and
• availability of effective treatment.
ESTABLISHING APPROPRIATE BIOSAFETY IN LABORATORY
ENVIRONMENTS

" Biosafety can be defined as practices that reduce exposure to harmful (biohazardous)
organisms and their products.

Harm in this context meaning causing disease.

" In scientific disciplines, exposures to biohazards may occur while conducting field
work or may take place in laboratories.

" BSL-1

" BSL-2

" BSL-3

" BSL-4

BSL-1 (BIOSAFETY LEVEL-1)

This laboratory setting typically consists of research taking place on benches without the use
of special contaminant equipment.

A BSL-1 lab, which is not required to be isolated from surrounding facilities, houses
activities that require only standard microbial practices, such as:

! Mechanical pipetting only (no mouth pipetting allowed)

! Safe sharps handling

! Avoidance of aerosols

! Daily decontamination of all work surfaces when work is complete

! Hand washing

! Prohibition of food, drink and smoking materials in lab setting

! Personal protective equipment, such as; eye protection, gloves and a lab coat or gown

! Biohazard signs

! BSL-1 labs also requires immediate decontamination after spills. Infection materials
are also decontaminated prior to disposal, generally through the use of an autoclave.
 BSL-2 (BIOSAFETY LEVEL-2)

In addition to BSL 1, the following practices are required in a BSL 2 lab setting:

! Appropriate personal protective equipment (PPE) must be worn, including lab coats
and gloves. Eye protection and face shields can also be worn, as needed.

! All procedures that can cause infection from aerosols are performed within a
biological safety cabinet (BSC).

! An autoclave or an alternative method of decontamination is available for proper

disposals.

! The laboratory has self-closing, lockable doors.

! A sink and eyewash station should be readily available.

! Biohazard warning signs

! Access to a BSL-2 lab is far more restrictive than a BSL-1 lab. Outside personnel, or
those with an increased risk of contamination, are often restricted from entering when
work is being conducted.

BSL-3 (BIOSAFETY LEVEL-3)

Common requirements in a BSL-3 laboratory include:

! Standard personal protective equipment must be worn, and respirators might be

required

! Solid-front wraparound gowns, scrub suits or coveralls are often required

! All work with microbes must be performed within an appropriate BSC

! Access hands-free sink and eyewash are available near the exit

! Sustained directional airflow to draw air into the laboratory from clean areas towards
potentially contaminated areas (Exhaust air cannot be re-circulated)

! A self closing set of locking doors with access away from general building corridors

! Access to a BSL-3 laboratory is restricted and controlled at all times.

! Laboratory personnel are also under medical surveillance and could receive
immunizations for microbes they work with.

BSL-4 (BIOSAFETY LEVEL-4)

In addition to BSL-3 considerations, BSL-4 laboratories have the following containment

requirements:

! Personnel are required to change clothing before entering, shower upon exiting
 ! Decontamination of all materials before exiting

! Personnel must wear appropriate personal protective equipment from prior BSL
levels, as well as a full body, air-supplied, positive pressure suit

! A Class III biological safety cabinet

! A BSL-4 laboratory is extremely isolated—often located in a separate building or in

an isolated and restricted zone of the building.

! The laboratory also features a dedicated supply and exhaust air, as well as vacuum
lines and decontamination systems.

CARTAGENA PROTOCOL ON BIOSAFETY

The Cartagena Protocol on Biosafety is “an international agreement which aims

to ensure the safe handling, transport and use of living modified organisms (LMOs)
resulting from modern biotechnology that may have adverse effects on biological
diversity and risks to human health”.

It was adopted on 29 January 2000 and entered into force on 11 September 2003.

Background of the Cartagena Protocol :

! The origin of the Cartagena Protocol dates back to the 1992 when United Nations
Conference on Environment and Development, held in Brazil.

! At that conference, more than 178 governments adopted an Agenda.

! Agenda was a comprehensive action plan for dealing with ways in which human
activities affect the environment; it included a chapter on ‘environmentally sound
management of biotechnology’.

! At the same meeting, the Convention on Biological Diversity (CBD) was opened for
signing in 1992.

The 3 principal objectives of this Convention are as follows:

1. – the conservation of biodiversity

2. – the sustainable use of its components

3. – the fair and equitable sharing of the benefits arising out of the utilisation of
genetic resources.
Why do we need an international biosafety agreement?

One of the issues addressed by the CBD is biosafety, i.e. the need to protect human health
and the environment from the potential adverse effects of the products of modern
biotechnology.

At the same time, biotechnology is recognized as having great potential for the promotion of
human well-being and for the sound management of the environment.

The CBD clearly recognizes these twin aspects of biotechnology and includes provisions for
both the promotion of biotechnology and the development of procedures to ensure its safety.

CBD decided to develop a biosafety protocol, and established the Biosafety protocol in
Cartagena, Colombia, in February 1999.

The full name of the Biosafety Protocol is "the Cartagena Protocol on Biosafety to the
Convention on Biological Diversity."

! The Protocol entered into force on 11 September 2003.

! Currently 170 countries are Parties to the Protocol.

India is a party of Cartagena Protocol (Joined in Jan 23, 2003)

! The Protocol promotes biosafety by establishing rules and procedures for the safe
transfer, handling, and use of LMOs.

! It includes Advance Informed Agreement (AIA) procedures for imports of LMOs

for intentional introduction into the environment, and also incorporates the
precautionary approach, and mechanisms for risk assessment and risk management.

! The Protocol establishes a Biosafety Clearing-House (BCH) to facilitate information

exchange between the parties.

Parties are required to use the BCH to communicate to other Parties, their contact
information, regulatory frameworks, results of import decisions, results of risk assessments,
occurrences of unintentional transboundary movements of LMOs, and several other types of
information.

! The Protocol attempts to resolve the respective needs of trade and environmental
protection in the light of rapidly growing biotechnology industry.

! The Protocol addresses the obligations of Parties in relation to the transboundary

movements of LMOs to and from non-Parties to the Protocol.
 BIOETHICS
Ethics: Ethics refers to the moral value of what is good or what is bad and the individual
judgments on values. These judgments are based on cultural and religious beliefs.

The term is derived from the Greek word ethos which can mean custom, habit, character or
disposition.

Ethics covers the following :

• how to live a good life

• our rights and responsibilities

• the language of right and wrong

• moral decisions - what is good and bad?

Bioethics: concerning life with ethics.

Bioethics includes the study of what is right and wrong in new discoveries and techniques in
biology, such as genetic engineering and the transplantation of organs.

Bioethics is a branch of ethics, which is the interdisciplinary study of problems

created by biological and medical progress , and its impact in society and value system, both
for now and for the future. “Bioethics” was first coined by Fritz Jahr in 1927

Social and Ethical Issues in Biotechnology

1. Release of genetically manipulated organisms (GMOs)
Release of living organisms in an environment in which they were absent earlier, has led to
enormous damage.

For example, in India, Parthenium and water hyacinth were unknown at the beginning of the
1950s
Since then, they have become major problems. Both these plants have spread all over the
country.

Parthenium allergy is one of the most common allergies in India today, and water hyacinth
has choked numerous lakes, river beds and water passages. Both have led to an enormous
expenditure in remedying or controlling the situation arising out of their spread across the
country. The origin of these plants is not absolutely clear, though it is believed that
Parthenium came as a weed along with the supplies of wheat from the US to India before the
green revolution in India.

Therefore, it is only appropriate that no genetically modified organism is released in the

environment unless it has been appropriately tested. Unfortunately, no GMO released so far
in the world – including India – has gone through such rigorous testing.

The first GMO that was approved to be released in a limited way in India was an Indian
version of Monsanto’s Bt cotton containing an insecticidal gene from Bacillus thuringenesis
developed by the Indian company, MAHYCO, in collaboration with Monsanto.

There has been wide spread criticism about its release permitted by the Government of India
in 2002, as this was done ignoring the ground realities in India such as the fact that, unlike in
the US where bollworm is the main cotton pest, we have numerous other pests associated
with cotton that are not susceptible to the Bt toxin.It was, therefore, no surprise that this Bt
cotton failed in several parts of the country.

The sad part of the story is that, in spite of this, Government of India renewed the permission
to Mahyco to continue to market and try the same Bt cotton in several other parts of the
country.

2. Stem cells
In India, the work on stem cells is fortunately being encouraged. There have been no protests
from any quarter in regard to work on stem cells in India.

This is in contrast to the stand of the President of the US in regard to research using human
stem cells. There is clearly a need for an international stem cell agreement.

3. Organ transplantation

As is widely known, the pig seems to be the most suitable animal for xenotransplantation of
organs on humans. Transplantation of organs from such a pig on to a human being would
then be no different from homo-transplantation, for the success of which the protocols are
already available and well established. When this becomes a reality, what about the Islamic
world? Will they accept a pig organ for, for them, pig is an unholy animal.

4. Assisted reproductive technologies and cloning

The most important ethical question in ART is: who should be the sperm or egg donor and
who may act as the surrogate mother. In India, so far, the sperm and egg donors have been
close relatives or close friends of the infertile couple or their families.
In the case of surrogacy, again, it is generally a close relative who agrees to act as a surrogate
mother for a couple who cannot or do not want to carry their own child.

Traditionally, if a couple is infertile in India, the family places the blame on the woman even
though we know today that in about half the diagnosable cases a male factor is the cause of
infertility. Even if the mother-in-law is convinced that her son has a problem, she would want
this to be kept as close a secret as possible. She, therefore, takes the daughter-in-law to an
infertility clinic and asks the doctor to inseminate her by the semen of the husband’s brother
or of a close family friend. The daughter-in law would normally have no say in this regard.
The psychological stress that she will go through for the rest of her life, including during
pregnancy, on account of the knowledge that the biological father of the child she is carrying
is someone whom she knows and has social interaction with all the time, would not be
generally a matter of concern to the rest of the family in India.

Now imagine the following scenario. A few years later, the mother-in-law and the daughter-
in-law quarrel which is not uncommon in our country as the joint family system is still in
vogue but under pressure on account of the changed circumstances. The mother-in-law says
publicly that her daughter-in-law has committed adultery and names the person with whom,
according to her, the adultery has been committed. DNA fingerprinting will establish that the
basis of mother-in-law‘s allegation that the child is not the daughter-in-law’s husband’s child
but of another man is correct, as infertility clinics are, as of today, not required to keep
appropriate records. There will be no way that the daughter-in-law can establish that she
never slept with the man who is the biological father of the child and that she was – in spite
of her protestations – artificially inseminated with his semen on account of the insistence of
the mother-in-law, which is not adultery. Such situations, and many variations of it, make the
use of the semen of a person known to the infertile couple or their family, for artificial
insemination, unethical.

Ethical and social issues associated with Surrogate pregnancies

Who may act as the surrogate mother?

The mother of the male partner OR the sister of the female partner.
In many cases in the country, a woman has given birth to her own grandchild. On the other
hand, there are also regular advertisements, for example in the magazine, Woman’s Era, for
surrogate motherhood.

It is believed that it is unethical to have a close relative act as a surrogate mother, especially
in the Indian environment where family ties are very close. In a closely-knit family, the fact
that the child was carried in the womb and then delivered by so-and-so will always be known
to the members of the family and, eventually, to the child after it grows older. Carrying a
child in one’s own womb is, in Indian society, the indication of a close relationship.
Therefore, it would be difficult for a child and the surrogate mother, if they see each other
everyday, for such a relationship not to come in the way of the child establishing the expected
relationship with the biological mother, without confusion in the child’s mind. The ideal
solution would be what is already being practiced by some country, that is, to advertise for a
surrogate on payment basis that will adequately compensate the woman who agrees to act as
a surrogate mother.

Lack of transparency in surrogacy can lead to some funny situations, as has happened
in India.
" In 2001, a woman came to one of the best-known maternity hospitals in
Hyderabad to be admitted for delivery.
" She wanted to be registered in the name of her sister, as she was acting as a
surrogate mother for her sister’s and brother-in-law’s child.
" Not having handled such a case earlier, the doctor-in-charge of the hospital, an
eminent and highly ethical person, agreed to this request, only to realize a little
later that this was a mistake.
" What would she do in case the woman died during childbirth? Whose death
certificate would she sign – of the sister in whose name the woman had
registered, or of the woman herself?
" This is an outstanding example of the lack of transparency leading to a difficult
situation.

The Indian preference for a male child

In India, all through history, there has been a preference for a boy.
The reasons for this have been many……..
A girl child becomes a financial burden on the parents.
" India is, in fact, today known for the large number of dowry deaths where the young
bride either kills herself or is killed by her in-laws for refusing to ask her parents, after
the marriage, for more money, in addition to what was initially agreed upon as the
dowry to be paid by the girl’s family.
" Under the above circumstances, there is an extreme desire on the part of a vast
majority of Indian couples to use modern technology to ensure the birth of only a
male child.
" One way in which this can be achieved is by abortion of the female fetuses.
" Therefore, the Government of India enacted a law prohibiting prenatal sex
determination (excepting for medical reasons, such as the possibility of the fetus
suffering from a genetic disorder).
 " However, the ground reality in India is that such a law is extremely difficult to
implement and, as of today, is followed more in breach than in practice. This is a
major ethical problem in the country today.
" The situation is made worse by advertisements in our newspapers by some infertility
clinics that they can give the couple a child of the desired sex, which, as it turns out,
is always a male, by prenatal sex selection, that is, by using the technology of
separating X and Y spermatozoa.
" The protagonists of these technologies argue in the following way.
" They say that if a couple already has a child of a particular sex and wants to have a
child of the other sex as the second child to balance their family,

Why should we not allow modern technology to be used for this purpose?

" They indicate, at least for argument’s sake, that if the first child is a boy and they
want to have a second child, why should we not permit them to abort a male fetus
in the second pregnancy, or permit the woman to be inseminated artificially with an
X-enriched sperm fraction of the spermatozoa obtained from the husband.

" Keeping in mind the situation obtained with the vast majority in the country, who,
today, consider a girl child a burden and a boy child an asset, and the fact that the
female : male ratio in the country has declined to socially dangerous levels.

" Such differences in Indian attitudes creating ethical and social issue.

5. Plant-based drug formulations

In India, there are some 40,000 plant-based drug formulations that are a part of the 4
documented Indian systems of medicine – the Ayurveda, the Unani, the Siddha, and the
Tibetian systems – and the undocumented tribal systems of medicine.

Some 7,000 plants are already known to be used in these formulations, and there are another
3,000 plants waiting to be documented as most tribal formulations are still not in public
domain.

Suppose you have obtained a traditional plant-based drug formulation from a tribe that the
tribe has been using for 1000 years.

And then you will subject it a rigorous procedure of standardization and validation to find
out whether it works or not. And it turns out that it works. You then commercialize and make
money out of it, without sharing it with the tribe.

" Would it be ethical?

" And even if you wished to share the profits, how much should go to the tribe?
There is a plant called Phyllanthus amarus, which has been used widely in virtually all parts
of our country in several indigenous medical systems of ours, as well as in many other parts
of the world, to cure certain liver disorders. Since the use of our traditional
drugs is based on symptoms, what is understood that the above plant-based
drug formulation could take care of certain symptoms, without the disease as
we know of it today having been identified.

What the Nobel prize-winning scientist, Barry Blumberg, who discovered the
hepatitis B virus, did was to show that extracts of Phyllanthus amarus
inhibited two key enzymes of the hepatitis B virus, and eliminated the virus from the system
in an animal model, thus indicating that the extract could be a cure for human hepatitis B and
might even eradicate the hepatitis B virus from the nearly 300 million carriers of the virus
around the world. He obtained two patents on this work , not giving any credit to ancient
Indian tradition for use of the plant for curing symptoms which correspond, amongst other
diseases, to hepatitis B.

Legally, these patents could not be challenged, as none of the ancient medical systems in our
country ever claimed to have cured hepatitis B using extracts of Phyllanthus amarus.

However, were these patents morally or ethically justified?

6. Bioinformatics
Using DNA chips, it would be possible for a physician to tell a parent as to what the diseases
are that a new-born child is likely to suffer from as it grows up. There is no problem for a
physician if the disease is like sickle-cell anemia, or thallasemia, or cystic fibrosis as, in such
cases, the child is bound to suffer from the disease.

Genetic disorders can be classified broadly into two categories.

In the case of one category, if you carry the particular defective gene(s), you are bound to
suffer from the disorder sooner or later in your life. This is the case with sickle cell anaemia,
thalassaemia, cystic fibrosis, haemophilia or albinism. There are, however, a much large
number of genes, called the susceptibility genes, the presence of which only makes one
susceptible to the disease sometime in the person’s life. As of today, we do not know what
environmental or life style factors are responsible for converting the susceptibility status in
such cases, to the diseased status later in the life of an individual. All that we can say today in
this regard is based entirely on statistical data; so we can only say what the chances are of a
person having a particular susceptibility gene, becoming diseased later in life.

In case of susceptibility genes, the doctor can only indicate the chances that the child would
have of suffering from the disease – let us say, type II diabetes?

We still do not know what are the life-style or other factors that lead to the conversion of the
susceptibility status to the disease status in the carriers of such genes. In the absence of this
knowledge, let us assume that the physician tells the mother that there are 50% chances of
her child suffering from diabetes after the child crosses age 40. But it happens that the child
doesn’t suffer from the disease and leads a normal life all through.

Could he, later, take legal action against the doctor for keeping him and his family under
suspense that he may suffer from the disease?

On the other hand, if the physician does not tell the parent about the presence of the gene in
the child, and it turns out that the child does suffer from the disease when it grows up, the
child and the parent can again take legal action against the doctor saying that he withheld
information which could have prepared them for the disease scenario.

How do we tackle this problem?

7. DNA fingerprinting
It is surprising that such a useful and clean technology as DNA fingerprinting can raise
ethical question…………… But here is one example….

A case of immigration was referred to the Centre for Cellular and Molecular Biology
(CCMB) at Hyderabad for a DNA fingerprint by the British immigration authorities. In this
case, an Indian couple living in England with two children had a third child in India while
they were visiting the country. When they wished to take the third child back to England, the
immigration authorities asked them to establish that they were the biological parents of the
child, to rule out the possibility that they were bringing an abandoned child for sale in the
United Kingdom.

The case was referred to the CCMB for DNA fingerprinting. When Lalji Singh, the former
Director of CCMB, did the DNA fingerprinting of the entire family, he found that while the
child born in India was the child of the husband and wife who were taking it to the UK, one
of the two children living with them in England was not their child.

The wife had committed adultery without the husband being aware of it.

The question that Lalji Singh faced was “what to say to the immigration authorities”.

If the truth was told to them and later became known to the parents, the family might break
up.

On the other hand, would hiding the truth be ethical? What Lalji Singh finally decided was to
answer only the question that he was asked by the immigration authorities, and keep to
himself the other relevant information that he had.

Did Lalji Singh do the right thing?

8. Biological weapons
Biological warfare is upon us. We can today design ethnic weapons that would affect only a
particular segment of world’s population.
For example, Americans over age 50 are known to have a depleted immune response.
Therefore, certain pathogenic organisms released in the environment would be likely to affect
only the elderly Americans but would leave the Indians, completely unaffected.

The depleted immune response in the older Americans could to be a fact that they have lived
in a virtually semi-sterile environment so that their immune system has not been challenged
enough.

On the other hand, we in India are being continuously challenged by low levels of infection
in our environment and, therefore, our immune system is robust.

We can thus exploit this advantage to produce an ethnic-specific weapon.

Would that be ethical?

Great Britain, the US, the USSR (now Russia), Canada, Germany, South Africa, Japan, Iraq,
Iran, Syria and North Korea are known to have had extensive biological weapons
development programme. The list of biological weapons on which considerable work has
been done includes nearly 60 bacteria, viruses, other organisms, and toxins.

Examples would be:

Viruses that cause smallpox, Ebola fever, Marburg fever, Lassa fever, and various
haemorrhagic fevers; Bacteria that cause anthrax, plague, glanders and tularemia; and Toxins
such as botulin and ricin.

Botulin is the most deadly poison known to us, its LD50 (the amount required o kill 50
percent of the exposed individuals) for human beings being 6 nanograms per kilogram
weight, that is, approximately 40 nano-grams per person. We may thus need just half-a-
kilogram of botulin to kill the entire population of the world, and the delivery of it would be
easy: just put it in the water supplies as botulin is an intestinal toxin. There is, indeed, no
doubt that biological weapons are the most dreaded ones today – far most dangerous than
nuclear, chemical or conventional weapons.

9. Tissue culture
One would normally think of tissue culture as one of the safest biotechnologies which is
neither polluting nor likely to pose any ethical or related problems,

But look at this possible scenario…..

We are all familiar with the fragrance of vanillin.

Till recently, the entire supply of vanillin of the world came from Malagasy Republic where
some 70,000 farmers have been involved in cultivation of vanillin.

Now, vanillin is likely to be produced more cheaply through tissue culture by American and
Japanese companies. Therefore, no market for vanillin produced naturally, and the 70,000
farmers may be facing unemployment?

Will this be fair?

There is a protein called thaumatin found in a particular plant endemic to parts of Africa such
as Nigeria. Thaumatin is 5000 times sweeter than sugar and is completely non-toxic. Being a
protein, it is degraded in the digestive tract after ingestion, and therefore, does not get into the
blood stream.

It has also been produced through genetic engineering.

It is believed that it may not be difficult to make it 50,000 times sweeter than sugar. Once we
do that, we can produce it at a cost that would be a fraction of the cost of the cheapest cane
sugar or beet sugar around the world. If that happens, some 7 million workers in the
sugarcane industry in the Third World alone may face unemployment. This would be a major
socio-economic problem.

How should we support ourselves to face it?

PUBLIC PERCEPTION OF BIOTECHNOLOGY

! Our perceptions (VIEWS) or attitudes (APPROACHES) toward things are not always
rational (BALANCED) and are often culturally influenced.

! They are a combination of thoughts/cognitive dimension, feelings/affective

dimension, and the way we react/the behavioral dimension.

! The cognitive dimension consists of things we know, the affective dimension

comprises of things we feel, and the behavioral dimension is how we will act on the
attitudes we build.

! Advancements in science and technology have made our life very simple and fast.

! At the same time some of this advancement has caused great concern regarding the
long-term impacts on environment and life.

! In 1985, the World Commission on Environment and Development (WCED)

recommended sustainable development preserving the environment without any
degradation.

! The Commission defined sustainable development as ‘the development that meets the
needs of the present without compromising the ability of future generations to meet
their own needs’.

There are two opposing ideologies regarding the use of science and technology:

• Holistic Ideology

• Reductionistic Ideology

% Holistic ideology recommends the use of traditional methods on all fronts of life from
agriculture to industry.
% This ideology argues that modern society gives more importance to formal knowledge
and neglects informal and traditional types of knowledge.

% According to this ideology, there is no problem in the agriculture sector. Earth can
produce sufficient food materials for the entire population, if we would return to
consume some of the old or traditional grains, which can be easily grown.

% It also recommends the use of chemical manures, pesticides, herbicides, and the use of
minimum tillage to conserve the land and to produce a crop.

% Whatever problem persists in the world is mainly due to the unequal distribution of
food that is produced.

% Reductionistic ideology argues for the use of new knowledge to improve the quality
of agriculture and crop plants. It recommends continuous research and development
studies to find out new solutions to problems.

% There are two things which dominate the public’s perception of biotechnology: lack
of trust and ignorance of science.

% Ignorance means that many people will have anxieties about the technology.

% Unless people can understand the issues, their perceptions will easily be influenced by
arguments that say that all biotechnology is morally dangerous, simply because of
their in-built fear of the unknown.

% Biotechnology holds great promise as a tool to preserve and enhance environmental

quality, food problems, and human health.

% It can create environmentally safe methods and technologies to address the problems
that affect humans and the environment.

% But without public understanding, acceptance, and support, the role that
biotechnology could play in solving environmental and food production problems
could be obstructed.

% To date, many countries have not developed any system or mechanism to manage the
social and ethical issues raised by biotechnology.

% Instead, government allocation of public money to the research and development has
determined the social consequences of biotechnology.