Chapter 20

Intellectual Property Rights (IPR),

Biosafety and Bioethics
Machiavelli Singh1* and Babita Khosla2
Amity Institute of Biotechnology, Amity University Haryana,
1

Gurugram (Manesar) – 122 413, Haryana, India

2
Department of Environmental Sciences, Maharshi Dayanand University,
Rohtak – 124 001 , Haryana, India
*e-mail: [email protected]

ABSTRACT
Ethical questions and Intelligence quotient have surrounded the development of biotechnology
right from the start. On the national and international level, bioethical committees have been set up
to clarify the boundaries of what is acceptable in biotechnology development and application. The care
with which bioethics are addressed is likely to have an influence on the marketability of products derived
from biotechnology, since it will finally be the consumers who decide the prospects of the biotechnology
markets. To assess, evaluate, prove, validate, and authenticate one must keep biosafety measures in
terms of check to ensure the safety on exploitation of biological system or processes towards the service
of mankind including individuals, community, and environment. Keeping in view to protect the rights
of innovators and creators towards lifelong incentives to gain along with freedom to operate via global
outreach in service of mankind is a much challenging and strategic task for humanity. In the present
chapter, developments of the intellectual property system in India, evaluation of an Intellectual Property
Regime, new dimensions and introduction to bioethics and the importance of biosafety management
with key to the conscious responsible operation of biotechnology is discussed.

Keywords: IPR, Patent, Copyright, Trademark, Geographical indication, TRIPS, WIPO, Bioethics,
Biosafety, Containment, Cartagena protocol.
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Intellectual Property Rights (IPR)

In 21st century the intellectual property system has become a tool for harnessing
the power of knowledge and creations of mind for development in the artistic,
scientific and technological fields worldwide. The dynamics of economic, social,
cultural and political factors in a democratic dialogue shape the evolution of
intellectual property system. The vitality of accumulated knowledge through
creative ideas and its innovative interpretation leads to recognition of intellectual
property (IP) as an important asset. Intellectual primarily focuses on intelligence as
either a professional or an individual capacity, genius that lies in the personality.
As a substantive or adjective, it refers to the work product of such persons or to an
aspect of something where learning, erudition, informed and critical thinking is
the focus. The property is something that can be owned, possessed, and expressed
with legal belongingness with evidence either in tangible or intangible form. It’s
the transformation of artistic, literary and scientific creations into a tangible asset
which is known as intellectual property. The rights which provide the protections
to these are intellectual property rights (WIPO, 2004). Intellectual property rights
are the basic rights given to the respective person over the creations of their minds,
thoughts and idea transformed into a tangible representative form. These give the
creator an exclusive right over the use of his/her creation for the certain period
(WIPO, 2004).

Intellectual Property (IP)

Intellectual property, very broadly, means the legal rights which result from intellectual
activity in the industrial, scientific, literary, and artistic fields. Countries have laws to
protect intellectual property for two main reasons. One is to give statutory expression
to the moral and economic rights of creators in their creations and the rights of the
public in access to those creations. The second is to promote, as a deliberate act of
Government policy, creativity and the dissemination and application of its results
and to encourage fair trading which would contribute to economic and social
development (WIPO, 2003).
Intellectual Property is defined in an all-pervasive sense in Article 2 (viii) of
the Convention Establishing the World Intellectual Property Organization (WIPO)
signed at Stockholm on July 14, 1967, to include the rights relating to literary, artistic
and scientific works; performances of performing artists. Intellectual property
rights as a collective term includes the following independent IP rights which
can be collectively used for protecting different aspects of an inventive work for
multiple protection: -Scientific discoveries, the remaining area mentioned in the
WIPO Convention, are not the same as inventions. The Geneva Treaty on the
International Recording of Scientific Discoveries (1978) defines a scientific discovery
as “the recognition of phenomena, properties or laws of the material universe not
hitherto recognized and capable of verification” (Article 1(1) (i)). Inventions are new
solutions to specific technical problems. Such solutions must, naturally, rely on the
properties or laws of the material universe (otherwise they could not be materially
or “technically” applied), but those properties or laws need not be properties or
Intellectual Property Rights (IPR), Biosafety and Bioethics | 525

laws “not hitherto recognized.” An invention puts to new use, to new technical
use, the said properties, or laws, whether they are recognized (“discovered”)
simultaneously with the making of the invention or whether they were already
recognized (“discovered”) before, and independently of, the invention (WIPO, 2004)

History and Development of Intellectual Property Law and

Recognition in India
Intellectual Property Right in India was adopted from the west. The Indian
Trade and Merchandise Marks Act 1884 was the first Indian Law regarding IPR.
The first Indian Patent Law was enacted in 1858 followed by series of Acts being
passed. They are Indian Patents and Design Act in 1911 and Indian Copyright
Act in 1914, Indian Trade and merchandise Marks Act and Indian Copyright Act
have been replaced by Trademarks Act 1958 and Copyright Act 1957 respectively
(Ganguli, 2003). After Independence in 1948, the Indian Government appointed the
first committee to review the prevailing Patents and Designs legislation. In 1957,
Government appointed Justice Rajgobala Ayyangar Committee (RAC) to revise
the Patent Law Rajagobala Ayyangar Committee submitted its report on 1959, the
report tried to balance the constitutional guarantee of economic and social justice
enshrined in the preamble of the constitution. This report outlined the policy behind
the Indian Patent System (Prabhu et al., 2012).
The conceptualization of the patent system was based on medium providing
an opportunity of acquiring exclusive rights in an invention, stimulates technical
process by encouraging research and innovation, inducing an inventor to disclose
discoveries, reward for developing inventions and facilitate to invest capital in new
lines of production which motivate the research and development culture.

1. Patent
A patent is an exclusive right granted by a country to the owner of an invention
to make, use, manufacture, and market the invention, provided the invention
satisfies certain conditions stipulated in the law. Exclusive right implies that no one
else can make, use, manufacture, or market the invention without the consent of
the patent holder. This right is available for a limited period. Despite the ownership
of the rights, the use or exploitation of the rights by the owner of the patent may
not be possible due to other laws of the country which has awarded the patent.
These laws may relate to health, safety, food, security etc. Further, existing patents
in similar area may also come in the way. A patent in the law is property right and
hence, can be gifted, inherited, assigned, sold or licensed. As the right is conferred
by the State, it can be revoked by the State under very special circumstances even if
the patent has been sold or licensed or manufactured or marketed in the meantime.
The patent right is territorial in nature and inventors/their assignees will have to
file separate patent applications in countries of interest, along with necessary fees,
for obtaining patents in those countries (WIPO, 2004). A new chemical process or
a drug molecule or an electronic circuit or a new surgical instrument or a vaccine
is a patentable subject matter provided all the stipulations of the law are satisfied.
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The Indian Patent Act

The first Indian patent laws were first promulgated in 1856. These were
modified from time to time. New patent laws were made after the independence in
the form of the Indian Patent Act 1970. The Act has now been radically amended to
become fully compliant with the provisions of TRIPS. The most recent amendment
was made in 2005 which were preceded by the amendments in 2000 and 2003. While
the process of bringing out amendments was going on, India became a member of
the Paris Convention, Patent Cooperation Treaty and Budapest Treaty. The salient
and important features of the present The Patent (Amendment) Act 2005 and Rules
2006 in force are described in the patentability subject matter section 5.2 below (The
Patent Act, 2005).
Patentability Subject Matter
A clear definition has now been provided for an invention, which makes it at
par with definitions followed by most countries. Invention means a new product
or process involving an inventive step and capable of industrial application. New
invention means any invention or technology which has not been anticipated by
publication in any document or used in the country or elsewhere in the world before
the date of filing of patent application with complete specification i.e., the subject
matter has not fallen in public domain or it does not form part of the state of the art.
Inventive step means a feature of an invention that involves technical advance as
compared to existing knowledge or having economic significance or both and that
makes the invention not obvious to a person skilled in the art “capable of industrial
application means that the invention is capable of being made or used in an industry”
Novelty
An invention will be considered novel if it does not form a part of the global
state of the art. Information appearing in magazines, technical journals, books,
newspapers etc. constitutes the state of the art. Oral description of the invention
in a seminar/conference can also spoil novelty. Novelty is assessed in a global
context. An invention will cease to be novel if it has been disclosed in the public
through any type of publications anywhere in the world before filing a patent
application in respect of the invention. Therefore, it is advisable to file a patent
application before publishing a paper if there is a slight chance that the invention
may be patentable. Prior use of the invention in the country of interest before the
filing date can also destroy the novelty. Novelty is determined through extensive
literature and patent searches. It should be realized that patent search is essential
and critical for ascertaining novelty as most of the information reported in patent
documents does not get published anywhere else. For an invention to be novel,
it need not be a breakthrough. No invention is small or big. Modifications to the
existing state of the art, process, or product or both, can also be candidates for patents
provided these were not earlier known. In a chemical process, for example, use of
new reactants, use of a catalyst, new process conditions can lead to a patentable
invention. Any innovation proved physically is considered for be new patent
registration provisionally.
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Inventiveness (Non-obviousness)
A patent application involves an inventive step if the proposed invention is not
obvious to a person skilled in the art i.e., skilled in the subject matter of the patent
application. The prior art should not point towards the invention implying that the
practitioner of the subject matter could not have thought about the invention prior
to filing of the patent application. Inventiveness cannot be decided on the material
contained in unpublished patents. The complexity or the simplicity of an inventive
step does not have any bearing on the grant of a patent. In other words, a very
simple invention can qualify for a patent. If there is an inventive step between the
proposed patent and the prior art at that point of time, then an invention has taken
place. A mere ‘scintilla’ of invention is sufficient to find a valid patent. It may be often
difficult to establish the inventiveness, especially in upcoming knowledge areas.
The reason is that it would depend a great deal on the interpretative skills of the
inventor and these skills will really be a function of knowledge in the subject area.
Industrial Applicability
An invention must possess utility for the grant of patent. No valid patent can
be granted for an invention devoid of utility. The patent specification should spell
out various uses and manner of practicing them, even if considered obvious. If you
are claiming a process, you need not describe the use of the compound produced
thereby. Nevertheless, it would be safer to do so. But if you claim a compound
without spelling out its utility, you may be denied a patent.
Non Patentable Inventions
An invention may satisfy the conditions of novelty, inventiveness, and
usefulness but it may not qualify for a patent under the following situations:
(i) An invention which is frivolous, or which claims anything obviously
contrary to well established natural laws e.g., different types of perpetual
motion machines.
(ii) An invention whose intended use or exploitation would be contrary to
public order or morality or which causes serious prejudice to human,
animal or plant life or health or to the environment e.g., a process for
making brown sugar will not be patented.
(iii) The mere discovery of a scientific principal or formulation of an abstract
theory e.g., Raman effect and Theory of Relativity cannot be patented.
(iv) The mere discovery of a new form of a known substance which does not
result in enhancement of the known efficacy of that substance or the mere
discovery of any new property or new use of a known substance or the
mere use of a known process, machine or apparatus unless such a known
process results in a new product or employs at least one new reactant. For
the purposes of this clause, salts, esters, polymorphs, metabolites, pure
form, particle size, isomers, mixtures of isomers, complexes, combinations
and other derivatives of known substance shall be considered to be the
same substance unless they differ significantly in properties with regard
to efficacy.
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(v) A substance obtained by a mere admixture resulting only aggregation of

the properties of the components thereof or a process for producing such‘
substance.
(vi) The mere arrangement or rearrangement or duplication of features of
known devices each functioning independently of one another in a known
way. If you put torch bulbs around an umbrella and operate them by a
battery so that people could see you walking in rain when it is dark, then
this arrangement is patentable as bulbs and the umbrella perform their
functions independently.
(vii) A method of agriculture or horticulture. For example, the method of
terrace farming cannot be patented.
(viii) Any process for medical, surgical, curative, prophylactic, diagnostic,
therapeutic or other treatment of human beings, or any process for a
similar treatment of animals to render them free of disease or to increase
economic value or that of their products. For example, a new surgical
technique for hand surgery for removing contractions is not patentable.
(viii) Inventions relating to atomic energy;
(ix) Discovery of any living thing or non-living substance occurring in nature;
(x) Mathematical or business methods or a computer program per se or
algorithms;
(xi) Plants and animals in whole or any part thereof other than microorganisms
but including seeds, varieties and species and essentially biological
processes for production and propagation of plants and animals;
(xii) A presentation of information;
(xiii) Topography of integrate circuits;
(xiv) A mere scheme or rule or method of performing mental act or method of
playing games;
(xv) An invention which, in effect, is traditional knowledge or which is
aggregation or duplication of known component or components.

Computer program per se as such has not been defined in the Act but would
generally tend to mean that a computer program without any utility would not
be patentable. Protection of seeds and new plant varieties is covered under the
Protection of Plant Varieties and Farmers Act of India 2001 (PPVFR Act of India,
2001), which is discussed under section 12 of the chapter. Similarly, topography
of integrated circuits (e.g., mother boards of electronic and digital gadgets) as well
as protection of undisclosed information can be protected by the means of trade
secrets and non-disclosure agreements.
Term of the Patent
Term of the patent will be 20 years from the date of filing for all types of
inventions.
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Provisional Specification
A provisional specification is usually filed to establish priority of the invention
in case the disclosed invention is only at a conceptual stage and a delay is expected
in submitting full and specific description of the invention. Although, a patent
application accompanied with provisional specification does not confer any legal
patent rights to the applicants, it is, however, a very important document to establish
the earliest ownership of an invention. The provisional specification is a permanent
and independent scientific cum legal document and no amendment is allowed in
this. No patent is granted based on a provisional specification.
Complete Specification
It may be noted that a patent document is a techno-legal document and it has to
be finalized in consultation with an attorney. Submission of complete specification
is necessary to obtain a patent. Complete specification must be submitted within
12 months of filing the provisional specification. This period can be extended by
3 months. It is not necessary to file an application with provisional specification
before the complete specification. An application with complete specification can
be filed right at the first instance.
Examination, Grant and Working of Patent
Compulsory License
Any time after three years from date of sealing of a patent, application for
compulsory license can be made provided following conditions
1. Reasonable requirements of public have not been met
2. Patented invention is not available to public at a reasonably affordable
price
3. Patented invention is not worked in India

Application outside India; and (b) either no direction has been given under
the secrecy clause of the Act or all such directions have been revoked. among
other things, reasonable requirements of public are not satisfied if working of
patented invention in India on a commercial scale is being prevented or hindered
by importation of patented invention.
Applicant’s capability including risk taking, ability of the applicant to work the
invention in public interest, nature of invention, time elapsed since sealing, measures
taken by patentee to work the patent in India will be considered. In case of national
emergency or other circumstances of extreme urgency or public noncommercial
use or an establishment of a ground of anti-competitive practices adopted by the
patentee, the above conditions will not apply. A patentee must disclose the invention
in a patent document for anyone to practice it after the expiry of the patent or practice
it with the consent of the patent holder during the life of the patent.
Timeline for Filing a Patent Application
Filing of an application for a patent should be completed at the earliest possible
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date and should not be delayed. An application filed with provisional specification,
disclosing the essence of the nature of the invention helps to register the priority
by the applicant.

Figure 20.1: The Patent Filing Process and Timeline in India (Puttaiah, 2014).

Patenting of Microbiological Inventions

The Indian Patent Act has now a specific provision regarding patenting of
microorganisms and microbiological processes. It is now possible to get a patent
for a microbiological process and products emanating from such processes.
As it is difficult to describe a microorganism on paper, a system of depositing
strain of microorganisms in some recognized depositories was evolved way back
in 1949 in USA. An international treaty called “Budapest Treaty” was signed in
Budapest in 1973 and later on amended in 1980. India became a member of this
Treaty, with effect from December 17, 2001. This is an international convention
governing the recognition of deposits in officially approved culture collections
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for the purpose of patent applications in any country that is a party to this treaty.
Because of the difficulties and virtual impossibility of reproducing a microorganism
from a description of it in a patent specification, it is essential to deposit a strain in
a culture collection centre for testing and examination by others.
An inventor is required to deposit the strain of a microorganism in a recognized
depository, which assigns a registration number to the deposited microorganism.
This registration number needs to be quoted in the patent application dealing with
the microorganism. Obviously a strain of microorganism is required to be deposited
before filing a patent application. It may be observed that this mechanism obviates
the need of describing a microorganism in the patent application. Further, samples
of strains can be obtained from the depository for further working on the patent.
There are many international depositories in different countries such as ATCC, DSM
etc. which are recognized under the Budapest Treaty. The Microbial Type Culture
Collection (MTCC) at Institute of Microbial Technology (IMTEC), Chandigarh is
the first Indian depository set up under the Budapest Treaty.

2. Copyright
Copyright is a right, which is available for creating an original literary or
dramatic or musical or artistic work. Cinematographic films including soundtrack
and video films and recordings on discs, tapes, perforated roll or other devices
are covered by copyrights. Computer programs and software are covered under
literary works and are protected in India under copyrights. The Copyright Act, 1957
as amended in 1983, 1984, 1992, 1994 and 1999 governs the copyright protection in
India. The total term of protection for literary work is the author’s life plus sixty
years. For cinematographic films, records, photographs, posthumous publications,
anonymous publication, works of government and international agencies the term
is 60 years from the beginning of the calendar year following the year in which the
work was published. For broadcasting, the term is 25 years from the beginning
of the calendar year following the year in which the broadcast was made (The
Copyright Act, 2005). Copyright gives protection for the expression of an idea
and not for the idea itself. For example, many authors write textbooks on physics
covering various aspects like mechanics, heat, optics etc. Even though these topics
are covered in several books by different authors, each author will have a copyright
on the book written by him/her, provided the book is not a copy of some other
book published earlier. India is a member of the Berne Convention, an international
treaty on copyright. Under this Convention, registration of copyright is not an
essential requirement for protecting the right. It would, therefore, mean that the
copyright on a work created in India would be automatically and simultaneously
protected through copyright in all the member countries of the Berne Convention.
The moment an original work is created, the creator starts enjoying the copyright.
However, an undisputable record of the date on which a work was created must be
kept. When a work is published with the authority of the copyright owner, a notice
of copyright may be placed on publicly distributed copies. The use of copyright
notice is optional for the protection of literary and artistic works. It is, however, a
good idea to incorporate a copyright notice. As violation of copyright is a cognizable
offence, the matter can be reported to a police station. It is advised that registration
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of copyright in India would help in establishing the ownership of the work. The
registration can be done at the office of the Registrar of Copyrights in New Delhi.
It is also to be noted that the work is open for public inspection once the copyright
is registered (The Copyright Act, 2005). Computer program in the Copyright Act
has been defined as a set of instructions expressed in words, codes, schemes or any
other form, including a machine-readable medium, capable of causing a computer to
perform a particular task or achieve a particular result. It is obvious that algorithms,
source codes and object codes are covered in this definition. It is advisable to file
a small extract of the computer program at the time of registration rather than
the full program. It is important to know that the part of the program that is not
being filed, would remain a trade secret of the owner but would have to be kept
well-guarded by the owner. It may be noted that computer programs will become
important in the area of medicines when one talks about codification of DNA and
gene sequencing. Generally, all copyrightable expressions embodied in a computer
program, including screen displays, are protectable. However, unlike a computer
program, which is a literary work, screen display is considered an artistic work and
therefore cannot be registered through the same application as that covering the
computer program. A separate application giving graphical representation of all
copyrightable elements of the screen display is essential. In the digital era, copyright
is assuming a new importance as many works transacted through networks such
as databases, multimedia work, music, information etc. are presently the subject
matter of copyright (WIPO, 2004).
Coverage Provided by Copyright
(i) Literary, dramatic and musical work. Computer programs/software are
covered within the definition of literary work.
(ii) Artistic work
(iii) Cinematographic films, which include soundtrack and video films.
(iv) Recording on any disc, tape, perforated roll or other device.

Infringement of Copyright
Copyright gives the creator of the work the right to reproduce the work, make
copies, translate, adapt, sell or give on hire and communicate the work to public. Any
of these activities done without the consent of the author or his assignee is considered
infringement of the copyright. There is a provision of ‘fair use’ in the law, which
allows copyrighted work to be used for teaching and research and development.
In other words making one photocopy of a book for teaching students may not
be considered an infringement, but making many photocopies for commercial
purposes would be considered an infringement. There is one associated right with
copyright, which is known as the ‘moral right’, which cannot be transferred and is
not limited by the term. This right is enjoyed by the creator for avoiding obscene
representation of his/her works.
Computer Program
A Computer includes any electronic or similar device having information
Intellectual Property Rights (IPR), Biosafety and Bioethics | 533

processing capabilities. Computer program means a set of instructions expressed in

words, codes, schemes or any other form, including a machine-readable medium,
capable of causing a computer to perform a particular task or achieve a particular
result. It is now possible to have copyrights both on object code and source
code. Generally, all copyrightable expressions embodied in a computer program,
including screen displays, are protectable. However, unlike a computer program,
which is a literary work, screen displays are artistic work and cannot therefore
be registered in the same application as that covering the computer program. A
separate application giving graphic representation of all copyrightable elements of
the screen display is necessary.
In the case of a program made in the course of author’s employment under
a contract of service or apprenticeship, the employer shall, in the absence of any
agreement to the contrary, be the first owner of the copyright. However, works
created by third parties on commission do not automatically vest the copyright in the
commissioning party. If the third party is an independent contractor, it is essential
for the commissioning party to obtain the copyright through a written deed of
assignment. It is a common misconception that the copyright automatically belongs
to the commissioning party. Thus, it is only where the developer is an employee
creating the work under a contract of service that the rights belong to the employer.
Transfer of Copyright
The owner of the copyright in an existing work or prospective owner of the
copyright in a future work may assign to any person the copyright, either wholly
or partially in the following manner.
i. For the entire world or for a specific country or territory; or
ii. For the full term of copyright or part thereof; or
iii. Relating to all the rights comprising the copyright or only part of such
rights.

3. Trademarks
A trademark is a distinctive sign, which identifies certain goods or services
as those produced or provided by a specific person or enterprise. Trademarks
may be one or combination of words, letters, and numerals. They may also consist
of drawings, symbols, three dimensional signs such as shape and packaging of
goods, or colours used as distinguishing feature. Collective marks are owned by an
association whose members use them to identify themselves with a level of quality.
Certification marks are given for compliance with defined standards. (Example ISO
9000.). A trademark provides to the owner of the mark by ensuring the exclusive
right to use it to identify goods or services, or to authorize others to use it in return
for some consideration (payment).
Well-known trademark in relation to any goods or services, means a mark
which has become so to the substantial segment of the public which uses such goods
or receives such services that the use of such mark in relation to other goods or
services would be likely to be taken as indicating a connection in the course of trade
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or rendering of services between those goods or services and a person using the
mark in relation to the first-mentioned goods or services (The Trademark Act, 2004).
Service Marks
The Indian Act of 1958 did not have any reference to service marks. Service
means service of any description that is made available to potential users and
includes the provision of services in connection with the business of 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. Marks used
to represent such services are known as service marks.
Certification Trademarks and Collective Marks
A certification trademark means a guarantee mark which indicates that
the goods to which it is applied are of a certain quality or are manufactured in
a particular way or come from a certain region or use some specific material or
maintain a certain level of accuracy. The goods must originate from a certain region
rather from a particular trader. Certification marks are also applicable to services and
the same parameters will have to be satisfied. Further these marks are registerable
just like any other trademark. AGMARK used in India for various food items is
a kind of certification mark although it is not registered as a certification mark;
the concept of certification mark was not in vogue at the time of introduction of
AGMARK (Prabhu, 2012).
A collective mark means a trademark distinguishing from those of others, the
goods or services of members of an association of persons (not being a partnership
within the meaning of the Indian Partnership Act, 1932), which is the proprietor
of the mark.
Term of a Registered Trademark
The initial registration of a trademark shall be for a period of ten years but may
be renewed from time to time for an unlimited period by payment of the renewal
fees.

4. Protection of Geographical Indications

Indications which identify a good as originating in the territory of a member
or a region or a locality in that territory, where a given quality reputation or other
characteristics of the good is attributable to its geographical origin. The concept
of identifying GI and protecting them is a new concept in India, perhaps in most
developing countries, and has come to knowledge in these countries after they
signed the TRIPS Agreement. It may be noted that properly protected GI will give
protection in domestic and international market. Stipulations of TRIPS would be
applicable to all the member countries. According to TRIPS, GI which is not or
cease to be protected in its country of origin or which has fallen into disuse in that
country cannot be protected. Homonymous GI for wines will get independent
protection. Each state shall determine conditions under which homonymous
Intellectual Property Rights (IPR), Biosafety and Bioethics | 535

indications will be differentiated from each other. Principles of national treatment

and fair competition are applicable. TRIPS provide for seizure of goods bearing
false indications of GI. TRIPS provide for refusal or invalidation of registration of
a trademark containing a GI with respect to goods not originating in the territory
indicated. The Geographical Indications of Goods (Registration and Protection) Act,
1999 along with Geographical Indications of Goods (Registration and Protection)
Rules 2002 are in force.
The term GI has been defined as “Geographical Indications”, in relation to
goods, means an indication which identifies such goods as agricultural goods,
natural goods or manufactured goods as originating, or manufactured in the territory
of a country, or a region or locality in that territory, where a given quality, reputation
or other characteristics of such goods is essentially attributable to its geographical
origin and in case where such goods are manufactured goods one of the activities of
either the production or of processing or preparation of the goods concerned takes
place in such territory, region or locality, as the case may be (The GI Act, 2004).
Applicants for GI’s Registration
Any association of persons or producers or any organization or authority
established by or under any law for the time being in force representing the interest of
the producers of the concerned goods, who are desirous of registering geographical
indication in relation to such goods shall apply in writing to the Registrar in such’
form and in such manner and accompanied by such fees as may be prescribed for the
registration of the geographical indication. It should be significantly distinguishable
from known designs or combination of known designs. It should not comprise or
contain scandalous or obscene matter.
Punishment for Falsifying GI
A sentence of imprisonment for a term between six months to three years and
a fine between fifty thousand rupees and two lakh rupees is provided in the Act.
The court may reduce the punishment under special circumstances.
Term of GI protection
The registration of a GI shall be for a period of ten years but may be renewed
from time to time for an unlimited period by payment of the renewal fees.

5. Industrial Design
We see so many varieties and brands of the same product (e.g. car, television,
personal computer, a piece of furniture etc.) in the market, which look quite different
from each other. If the products have similar functional features or have comparable
price tags, the eye appeal or visual design of a product determines the choice. Even
if the similarities are not close, a person may decide to go for a more expensive item
because that item has a better look or color scheme.
What is being said is that the external design or color scheme or ornamentation
of a product plays a key role in determining the market acceptability of the product
over other similar products. If you have a good design that gives you an advantage,
536 | Handbook of Biotechnology

then you must have a system to protect its features otherwise there would be wide
scale imitation (WIPO, 2004). Design as per the Indian Act means the features of
shape, configuration, pattern, ornament or composition of lines or colors applied to
any article - whether in two dimensional or three dimensional or in both forms - by
any industrial process or means, whether manual, mechanical or chemical, separate
or combined, which in the finished article appeal to and are judged solely by the eye;
but it does not include any mode or principle of construction or anything which is
in substance a mere mechanical device. In this context an article means any article
of manufacture and any substance, artificial, or partly artificial and partly natural;
and includes any part of an article capable of being made and sold separately.
Stamps, labels, tokens, cards, etc. cannot be considered an article for the purpose of
registration of design because once the alleged design i.e., ornamentation is removed
only a piece of paper, metal or like material remains and the article referred to ceases
to exist. An article must have its existence independent of the designs applied to
it. So, the design as applied to an article should be integral with the article itself.
In India the registration is covered under The Design Act 2000 along with Design
Rules 2001 (The Design Act, 2004).
The Essential Requirements for the Registration of Design
1. The design should be new or original, not previously published or used
in any country before the date of application for registration. The novelty
may reside in the application of a known shape or pattern to a new subject
matter. However, if the design for which the application is made does not
involve any real mental activity for conception, then registration may not
be considered.
2. The design should relate to features of shape, configuration, pattern
or ornamentation applied or applicable to an article. Thus, designs of
industrial plans, layouts and installations are not registrable under the
Act.
3. The design should be applied or applicable to any article by any industrial
process.
Normally, designs of artistic nature such as painting, sculptures and the
like which are not produced in bulk by any industrial process are excluded
from registration under the Act.
4. The features of the designs in the finished article should appeal to and are
judged solely by the eye. This implies that the design must appear and
should be visible on the finished article, for which it is meant. Thus, any
design in the inside arrangement of a box, money purse or almirah may
not be considered for showing such articles in the open state, as those
articles are generally put in the market in the closed state.
5. Any mode or principle of construction or operation or anything, which is
in substance a mere mechanical device, would not be a registrable design.
For instance, a key having its novelty only in the shape of its corrugation
or bend at the portion intended to engage with levers inside the lock it is
Intellectual Property Rights (IPR), Biosafety and Bioethics | 537

associated with, cannot be registered as a design under the Act. However,

when any design suggests any mode or principle of construction or
mechanical or other action of a mechanism, a suitable disclaimer in respect
thereof is required to be inserted on its representation, provided there are
other registrable features in the design.
6. The design should not include any trademark or property mark or artistic
works. trademarks under this Act.

Duration of the Tegistration of a Design

The total term of a registered design is 15 years. Initially the right is granted
for a period of 10 years, which can be extended, by another 5 years by making an
application and by paying a fee of Rs. 2000/- to the Controller before the expiry of
initial 10 years period. The proprietor of design may make the application for such
extension even as soon as the design is registered.

6. The Protection of Plant Varieties and Farmer’s Right (PPV and

FR) Act of India
Plant genetic resources (PGRs) are the foundation for the development of a food
and nutritionally secure society. In addition, plants have many uses, including feed,
fibre, medicine and industrial applications. PGRs were treated as the ‘heritage of
mankind’ and were shared freely among nations, till the concerns for conservation
of biological diversity were raised by the Convention on Biological Diversity (CBD),
which came into force in 1993. The conservation and sustainable utilization and
access to biological diversity were considered as national sovereignty by CBD.
Consequently, many issues regarding the rights of the conservers, users, breeders,
farmers and intellectual property have emerged (Brahmi et al., 2004).
In order to provide for the establishment of an effective system for the protection
of plant varieties, the rights of farmers and plant breeders and to encourage the
development of new varieties of plants it has been considered necessary to recognize
and to protect the rights of the farmers in respect of their contributions made at any
time in conserving, improving and making available plant genetic resources for the
development of new plant varieties. The Govt. of India enacted “The Protection of
Plant Varieties and Farmers’ Rights (PPV and FR) Act, 2001 and Rules 2003” adopting
sui generis system. Indian legislation is not only in conformity with International
Union for the Protection of New Varieties of Plants (UPOV), 1978, but also have
sufficient provisions to protect the interests of public/private sector breeding
institutions and the farmers. The legislation recognizes the contributions of both
commercial plant breeders and farmers in plant breeding activity and also provides
to implement TRIPS in a way that supports the specific socio-economic interests of
all the stakeholders including private, public sectors and research institutions, as
well as resource-constrained farmers.
To implement the provisions of the Act the Department of Agriculture and
Cooperation, Ministry of Agriculture established the Protection of Plant Varieties
and Farmers’ Rights Authority on 11th November, 2005.
538 | Handbook of Biotechnology

The main objectives of the PPV and FR Act, 2001 framed are as under:
1. To establish an effective system for the protection of plant varieties, the
rights of farmers and plant breeders and to encourage the development
of new varieties of plants.
2. To recognize and protect the rights of farmers in respect of their
contributions made at any time in conserving, improving and making
available plant genetic resources for the development of new plant
varieties.
3. To accelerate agricultural development in the country, protect plant
breeders’ rights; stimulate investment for research and development both
in public and private sector for the development of new plant varieties.
4. Facilitate the growth of seed industry in the country which will ensure
the availability of high quality seeds and planting material to the farmers.

The breeder shall be required to deposit the seed or propagating material

including parental line seeds of registered variety to the Authority. An applicant has
to submit a fixed amount of seed sample (breeder seed) with prescribed germination
percentage, physical purity and phyto-sanitary standards. The applicant shall also
submit along with the seed/propagating material and the seed quality test report.
The seed samples received by the Authority will be properly tested for its purity
and germination. A part of the seed sample sent to the test centre for conduct of
distinct, uniform and stability (DUS) tests and a part of is kept by the Authority in
the National Gene Bank to maintain the seed samples of the registered varieties for
their entire period of protection.
The duration of protection of registered varieties is different for different type
of crops which are as below:
1. Trees and vines - 18 years.
2. For other crops - 15 years.
3. For extant varieties (means a variety available in India) notified - 15 years
from the date of notification under section 5 of the Seeds under section 5
of the Seeds Act, 1966 Act, 1966.

Management of IPR in Publicly Funded Institutions in India

The aims of publicly funded institutions such as universities, colleges,
autonomous bodies and public sector undertakings are multifaceted and are
not purely driven by economic considerations but they are primarily driven by
considerations of social obligations and political objectives and will of a nation. India
has stuck to these aims since the independence. On one hand the above approach
has helped us in creating a pool of highly educated population and also building
an inherent strength in research and development and core competency in basic
industries like steel, power, fertilizers etc. However on the other hand, an insulated
system breeds complacency, which blunts the spirit of innovation and fire for being
ahead of others. Globalization has taught us many new lessons by opening our eyes
Intellectual Property Rights (IPR), Biosafety and Bioethics | 539

to the existing and forthcoming ground realities, which cannot be shunned away
just because we do not happen to like them.
In order to maintain a continuous stream of new ideas and experimentation,
public private partnership in R and D would need to be nurtured to arrive at a win-
win situation. Therefore all publicly funded institutions and agencies will have to
come to terms with the new ground realities and take positive steps to direct research
suitably to generate more intellectual property rights, protect and manage them
efficiently in respect of such institutions, especially related to their management and
funding sources. It has been observed that educational and R and D institutions are
being asked to generate their own funds and depend less and less on block grants
by central or state governments. In respect of public sector undertaking (PSU) the
message has been to generate more and more revenue from the available resources.
The Central Government was quick to understand the importance of innovations
and new ideas for adjusting to new streams of paradigm shifts. The Government
also realized that the journey is not going to be smooth, easy or straight forward
in the absence of indigenous knowledge about new paradigms among scientists,
technologists and policy makers.

B. Bioethics and Biosafety

Bioethics is the study of moral choices arising from human involvement
with life which may include an assessment of benefits and risks related to human
interventions, especially with new technologies, and looks at balancing pursuit of
individual autonomy with the duties of justice. Bioethics demands that technology
assessment be thorough, and include assessment of the impact upon societies and
individuals (Macer, 1997)
Biosafety in a broader term is used in reference to policy frameworks and actions for
assessment and management of the safe application of modern biotechnology, frequently
referred to as genetic engineering. Concepts of safety are applied with respect to
hazards that modern biotechnology may pose to human and animal health as
well as to the environment. The risks include related non-technology concerns of a
social, ethical or political nature (Persley and Doyle, 1999). In this context therefore,
biosafety is a concept that is being applied to regulate situations in which products of
biotechnology are introduced into the environment directly as genetically modified
crops, animals and microbes or through derived products such as food, cosmetics,
drugs and other biologicals.
Bioethics is basically documented as our concern and values that we realise
while directly or indirectly connecting with the biological system, what we perceive
from our experience and thought is that there are at least three ways to express
bioethics (Macer, 1998):
1. Descriptive bioethics is the way people view life, their moral interactions
and responsibilities with living organisms in their life. Everyone already
has their own bioethics, and this evolves through our life and experience.
2. Prescriptive bioethics is to tell others what is ethically good or bad, or
what principles are most important in making such decisions. It may also
540 | Handbook of Biotechnology

be to say something or someone has rights, and others have duties to them.
We may re-examine our own bioethics and change, and also offer advice
to our society on how to change.
3. Interactive bioethics is discussion and debate between people, groups
within society, and communities about descriptive and prescriptive
bioethics. In a global society the richness of interactive bioethics should
improve, but it can only do so if we are tolerant of others.

There are a set of principles or ideals which people use as a common ground
for bioethics. They include the autonomy of individuals to make choices, while
respecting the choices of others, justice. In all things we do, the ideal is to avoiding
doing harm, and trying to do good.

1. Biosafety Guidelines
The World Health Organization (WHO) has long recognized that safety and,
in particular, biological safety are important international issues. WHO issued the
the Laboratory biosafety guidelines in form of manual in 1983, 1993 and safety
information 1997 and followed by last updated 2004. The manual encouraged
countries to accept and implement basic concepts in biological safety and to develop
national codes of practice for the safe handling of pathogenic microorganisms in
laboratories within their geographical borders. Since then, many countries have used
the expert guidance provided in the manual to develop such codes of practice. WHO
continues to provide international leadership in biosafety by addressing biological
safety and security issues facing us in the current millennium. The clear instructions
on risk assessment, safe use of recombinant DNA technology and transport of
infectious materials. Recent world events COVID-19 pandemic has revealed new
threats to public health through deliberate misuse and release of microbiological
agents. The protection of microbiological assets from theft, loss or diversion, which
could lead to the inappropriate use of these agents to cause public health harm lead
to the introduction of the biosecurity concept. WHO Laboratory biosafety practices
are helpful to nations that accept the challenge to develop and establish national
codes of practice for securing microbiological assets, yet ensuring their availability
for clinical, research and epidemiological purposes (WHO, 2004).

2. Risk Groups
The World Health Organization have internationally classified and made to the
relative hazards of infective microorganisms by risk group (WHO Risk Groups 1, 2,
3 and 4). This risk group classification is to be used for laboratory work only. The
factors used to determine which risk group an organism falls into is based upon
the characteristics of the organism, such as below:
P Pathogenicity
P Infectious dose
P Mode of transmission
P Host range
Intellectual Property Rights (IPR), Biosafety and Bioethics | 541

P Availability of effective preventive measures

P Availability of effective treatment.

These classifications presume ordinary circumstances in the research laboratory

or growth in small volumes for diagnostic and experimental purposes. The four
levels of risk have been defined as follows:
Risk Group 1 (no or very low individual and community risk)
A microorganism that is unlikely to cause human or animal disease.
Risk Group 2 (moderate individual risk, low community risk)
A pathogen that can cause human or animal disease but is unlikely to be a
serious hazard to laboratory workers, the community, livestock or the environment.
Laboratory exposures may cause serious infection, but effective treatment and
preventive measures are available and the risk of spread of infection is limited.
Risk Group 3 (high individual risk, low community risk)
A pathogen that usually causes serious human or animal disease but does not
ordinarily spread from one infected individual to another. Effective treatment and
preventive measures are available.
Risk Group 4 (high individual and community risk)
A pathogen that usually causes serious human or animal disease and that can be
readily transmitted from one individual to another, directly or indirectly. Effective
treatment and preventive measures are not usually available.

3. Containment
Containment facilities for different Risk Groups as per the recommendations
of World Health
Organization (DBT, 1990). The term “Containment” is used in describing the
safe methods for managing infectious agents in the laboratory environment where
they are being handled or maintained.
Purpose of containment: To reduce exposure of laboratory workers, other
persons, and outside environment to potentially hazardous agents.
Types of Containment
Biological Containment (BC)
In consideration of biological containment, the vector (plasmid, organelle, or
virus) for the recombinant DNA and the host (bacterial, plant, or animal cell) in
which the vector is propagated in the laboratory will be considered together. Any
combination of vector and host which is to provide biological containment must be
chosen or constructed to limit the infectivity of vector to specific hosts and control
the host-vector survival in the environment. These have been categorized into two
levels; one permitting standard biological containment and the other even higher
that relates to normal and disabled host-vector systems respectively.
542 | Handbook of Biotechnology

Physical Containment (PC)

The objective of physical containment is to confine recombinant organisms
thereby preventing the exposure of the researcher and the environment to the
harmful agents. Physical containment is achieved using i) Laboratory Practice,
ii) Containment Equipment, and iii) Special Laboratory Design. The protection of
personnel and the immediate laboratory environment from exposure to infectious
agents, is provided by good microbiological techniques and the use of appropriate
safety equipment, (Primary Containment).
The protection of the environment external to the laboratory from exposure to
infectious materials, is provided by a combination of facility design and operational
practices, (Secondary Containment).
Elements of Containment
The three elements of containment include laboratory practice and technique,
safety equipment and facility design.
i) Laboratory Practice and Technique
P Strict adherence to standard microbiological practices and techniques
P Awareness of potential hazards
P Providing/arranging for appropriate training of personnel
P Selection of safety practices in addition to standard laboratory practices
if required
P Developing of adopting a biosafety or operations manual which identifies
the hazards

ii) Safety Equipment (Primary barriers)

Safety equipment includes biological safety cabinets and a variety of enclosed
containers (e.g., safety centrifuge cup). The biological safety cabinet (BSC) is the
principal device used to provide containment of infectious aerosols generated by
many microbiological procedures. Three types of BSCs (Class I, II, III) are used in
microbiological laboratories. Safety equipment also includes items for personal
protection such as gloves, coats, gowns, shoe covers, boots, respirators, face shields
and safety glasses, etc.
iii) Facility Design (Secondary barriers)
The design of the facility is important in providing a barrier to protect persons
working in the facility but outside of the laboratory and those in the community from
infectious agents which may be accidentally released from the laboratory. There are
three types of facility designs: viz, the Basic Laboratory (for Risk Group I and II),
the Containment Laboratory (for Risk Group III) and the Maximum Containment
Laboratory (for Risk Group IV).

4. Biosafety Levels
It consists of a combination of laboratory practices and techniques, safety
Intellectual Property Rights (IPR), Biosafety and Bioethics | 543

equipment and laboratory facilities appropriate for the operations performed

and the hazard posed by the infectious agents. The guidelines for Microbiological
and Biomedical Laboratories suggest four Biosafety levels in incremental order
depending on the nature of work. Additional flexibility in containment levels can be
obtained by combination of the physical with the biological barriers. The proposed
safety levels for work with recombinant DNA technique take into consideration
the source of the donor DNA and its disease-producing potential. These four levels
correspond to (BSL1<BSL2<BSL3<BSL4) facilities approximate to 4 risk groups
assigned for etiologic agents.
These levels and the appropriate conditions are enumerated as follows: The
classification of organisms according to risk group is not meant to establish the
actual handling of biological hazards in the laboratory setting. For example, the risk
group system does not consider the procedures that are to be employed during the
manipulation of a particular organism. Containment levels are selected to provide
the end-user with a description of the minimum containment required for handling
the organism safely in a laboratory setting. In addition to the inherent characteristics
of each organism as described under different section, the containment system
includes the engineering, operational, technical and physical requirements for
manipulating a particular pathogen. These containment levels are applicable to
facilities such as diagnostic, research, clinical, teaching and production facilities
that are working at a laboratory scale. There are four (4) biosafety or containment
levels are described as follows (DBT, 1990).
1. Biosafety Level 1 is suitable for work involving well-characterized agents
not known to cause disease in healthy adult humans, and of minimal
potential hazard to laboratory personnel and the environment.
2. Biosafety Level 2 is like Level 1 and is suitable for work involving agents
of moderate potential hazard to personnel and the environment.
3. Biosafety Level 3 is applicable to clinical, diagnostic, teaching, research,
or production facilities in which work is done with indigenous or exotic
agents which may cause serious or potentially lethal disease because of
exposure by the inhalation route.
4. Biosafety Level 4 is required for work with dangerous and exotic agents
which pose a high individual risk of aerosol-transmitted laboratory
infections and life-threatening disease.

The relation of risk groups to different biosafety levels, type of work, practices
and equipment required are described in the matrix form in Table 20.1.

5. Biological Safety Cabinets (BSC)

Laboratory techniques may produce aerosols, which can contain hazardous
research materials, such as infectious agents that laboratory workers could inhale.
Biological safety cabinets (BSC) are one type of primary barrier to contain potentially
infectious research materials to prevent exposure of laboratory personnel and
contamination of the general environment.
544 | Handbook of Biotechnology

Table 20.1: Relation of Risk Groups to Biosafety Levels, Practices and Equipment’s

Risk Group Biosafety Laboratory Laboratory Practices Safety Equipment

(RG) Level (BSL) type
1 Basic – Basic teaching, Good Microbiological None; open benchWork
Biosafety research Techniques (GMT)
Level 1
2 Basic – Primary health GMT plus protective Open bench plus BSC for
Biosafety services. clothing, biohazard potential Aerosols
Level 2 diagnostic, sign
research
3 Containment Special As Level 2 plus special BSC and/or other primary
– Biosafety diagnostic, clothing, controlled devices for all activities
Level 3 research access, directional
airflow
4 Maximum Dangerous As Level 3 plus Class III BSC, or
Containment pathogen units airlock entry, shower positive pressures uits in
– Biosafety exit, special waste conjunction with Class
Level 4 disposals II BSCs, double-ended
autoclave (through the
wall), filtered air

Containment of hazardous aerosols in biological safety cabinets occurs by air

barriers, physical barriers, and high-efficiency particulate air (HEPA) filtration. Air
barriers provide containment by providing directional airflow from the laboratory,
past the researcher, and into the cabinet via the work opening. Hazardous aerosols
generated during experimental procedures inside the cabinet become captured
and carried by the flow of air, and trap within HEPA filters. Some BSCs provide
protection for experimental procedures by providing uniform, unidirectional HEPA
filtered air, referred to as laminar airflow, continuously flowing over the work area.
Laminar airflow minimizes turbulence inside the cabinet, allowing for immediate
removal of contaminants generated by the procedures.

Classification of Biological Safety Cabinets

There are three classes of biological safety cabinets, designated as Class I,
Class II, and Class III. Class I and II cabinets have a protective air barrier across the
work opening that separates the laboratory researcher from the work area. Class II
cabinets also provide a HEPA-filtered, clean work area to protect the experiment
from room contamination. Class III cabinets have a physical barrier between the
operator and the work area. Arm length rubber gloves sealed to glove ports on the
cabinet provide the operator with access to the work area.

6. Implementation of Biosafety Guidlines

For implementation of the guidelines it is necessary to have an institutional
mechanism to ensure the compliance of requisite safeguards at various levels. The
guidelines prescribe specific actions that include establishing safety procedures
for rDNA research, production and release to the environment and setting up
containment conditions for certain experiments (DBT, 2017). The guidelines suggest
Intellectual Property Rights (IPR), Biosafety and Bioethics | 545

compliance of the safeguards through voluntary as well as regulatory approach.

In this connection, it is proposed to have a mechanism of advisory and regulatory
bodies to deal with the specific and discretionary actions on the following:
a. Self-regulation and control in the form of guidelines on recombinant
research activities; and
b. Regulation of large-scale use of engineered organisms in production
activity and release of organisms in environmental applications under
statutory provisions.

The institutional mechanism as proposed for implementation of guidelines

and they are mainly consists of the following:
i. Recombinant DNA Advisory Committee (RDAC)
ii. Review Committee on Genetic Manipulation (RCGM)
iii. Genetic Engineering Approval Committee (GEAC)
iv. Institutional Biosafety Committee (IBSC)
v. Monitoring cum Evaluation Committee (MEC)
vi. State Biotechnology Coordination Committee (SBCC)
vii. District Level Committee (DLC)

Under Biosafety Research programme main emphasis is given to facilitate the

implementation of biosafety procedures, rules and guidelines under Environment
(Protection) Act 1986 and Rules 1989 to ensure safety from the use of Genetically
Modified Organisms (GMOs) and products thereof in research and application to the
users as well as to the environment. A three tier mechanism comprising Institutional
Biosafety Committees (IBSC) at the Institute/company; the Review Committee on
Genetic Manipulation (RCGM) in the Department of Biotechnology; and the Genetic
Engineering Approval Committee (GEAC) in the Ministry of Environment and
Forests (MoE and F) for granting approval for research and development activities on
recombinant DNA products, environmental release of genetically engineered (GE)
crops and monitoring and evaluation of research activities involving recombinant
DNA technology has been established. Applications in pharma/agriculture
sectors for import/export/transfer/exchange of GE materials including GE seeds,
conduct of pre-clinical toxicity studies, evaluation of pre-clinical study reports and
recommendations to DCGI for appropriate phase of clinical trials of new drug(s)
or similar biologics, confined field trials on GE crops etc., were examined by the
RCGM and appropriate decisions were taken. RCGM has taken several policy
decisions on biosafety research on agricultural/bio-pharmaceuticals/industrial
products (DBT, 2017).

7. The Cartagena Protocol on Biosafety

The Cartagena Protocol on Biosafety (hereafter referred to as ‘the Protocol’), is
an international agreement that was adopted on 29 January 2000 as a supplementary
agreement to the Convention on Biological Diversity (CBD). It addresses the
potential adverse effects on biodiversity, taking also into account risks to human
546 | Handbook of Biotechnology

health, of living modified organisms (LMOs), which are defined in the Protocol
as any living organism that possesses a novel combination of genetic material
obtained using modern biotechnology (CBD Secretariat, 2000). The term LMO is
usually considered to be synonymous with GMO (genetically modified organism)
or other similar terms, although precise definitions may vary. The Protocol focuses
on trans-boundary movements and is therefore relevant to international trade in
LMOs. While the Protocol deals exclusively with LMOs, its remit overlaps with
that of other international bodies and agreements that deal to some extent with
transgenic organisms. The relevant bodies and agreements to international trade
are World Organization for Animal Health (OIE), the International Plant Protection
Convention (IPPC), Organization for Economic Cooperation and Development
(OECD) and the Codex Alimentarius Commission (Codex). It will be important
for all countries that have ratified (hereafter referred to as ‘the Parties’) to consider
the work done by these organizations on the particular issues for which they have
specific responsibility.
The origin of the Cartagena Protocol dates to the 1992 United Nations Conference
on Environment and Development, held in Rio de Janeiro. At that meeting, more
than 178 governments adopted Agenda 21, which 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 CBD was opened for signing.
The three principal objectives of this Convention are as follows:
P The conservation of biodiversity
P The sustainable use of its components
P The fair and equitable sharing of the benefits arising out of the utilization
of genetic resources.

The one of the key 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 (CBD Secretariat, 2000). 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, the objective
of this Protocol is to contribute to ensuring an adequate level of protection in the
field of the safe transfer, handling and use of living modified organisms resulting
from modern biotechnology that may have adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to human health,
and specifically focusing on transboundary movements. The scope of the Protocol
is described in Article 4, and highlights this focus on transboundary movements:
This Protocol shall apply to the transboundary movement, transit, handling and use
of all living modified organisms that may have adverse effects on the conservation
and sustainable use of biological diversity, taking also into account risks to human
health.’ The Protocol came into force in September 2003.
Intellectual Property Rights (IPR), Biosafety and Bioethics | 547

8. Good Laboratory Practice (GLP)

It refers to a system of management controls for laboratories and research
organizations to ensure the consistency and reliability of results as outlined in the
Organization for Economic Cooperation and Development (OECD) Principles of
GLP and national regulations. GLP applies to non-clinical studies conducted for the
assessment of the safety of chemicals to man, animals and the environment (WHO,
2009). The internationally accepted definition is as follows:
Good Laboratory Practice (GLP) embodies a set of principles that provides a
framework within which laboratory studies are planned, performed, monitored,
recorded, reported and archived. These studies are undertaken to generate data
by which the hazards and risks to users, consumers and third parties, including
the environment, can be assessed for pharmaceuticals, agrochemicals, cosmetics,
food and feed additives and contaminants, novel foods and biocides. GLP helps
assure regulatory authorities that the data submitted are a true reflection of the
results obtained during the study and can therefore be relied upon when making
risk/safety assessments.
Good Clinical Practice (GCP) is an international ethical and scientific quality
standard for designing, conducting, recording and reporting trials that involve the
participation of human subjects. Compliance with this standard provides public
assurance that the rights, safety and well-being of trial subjects are protected,
consistent with the principles that have their origin in the Declaration of Helsinki
(ICH GCP Guideline).
Good Clinical Laboratory Practice (GCLP) applies those principles established
under GLP for data generation used in regulatory submissions relevant to the
analysis of samples from a clinical laboratory practice as defined in this document
are complied with in their facility.

Biosafety Management
Although the responsibility for the safety of staff lies with the supervisors
and directors of the microbiology laboratory, it can be advantageous to identify an
individual(s) to specifically manage biological safety issues. In many laboratories,
this role is either informally assigned to a qualified individual who performs these
duties on a part-time basis (e.g., senior microbiologist) or the role is shared by several
individuals. This role can also be formally assigned to a dedicated Biological Safety
Officer who has a working knowledge of the laboratory practices and procedures
within the facility. The formation of an Institutional Biosafety Committee to oversee
the facility’s biological safety program can also be incorporated into the structure for
the management of biological safety issues (in some institutions and universities, the
requirement for an Institutional Biosafety Committee is mandatory). The Biological
Safety Officer (or individual assigned to manage biological safety issues) should
liaise with the Committee through regularly scheduled meetings and can present
specific safety problems, concerns or policy/protocol improvements to be considered
and addressed. The Committee is also available to the Biological Safety Officer for
risk assessments, disputes about biological safety matters or other matters that
may be of a biological safety nature. Careful consideration is to be given to the
548 | Handbook of Biotechnology

composition of the Institutional Biosafety Committee, which, when possible, should

include several individuals with varying expertise, the Biological Safety Officer,
at least one member of each of the research staff (researcher) and technical staff
(technician), and a representative from management. Consideration should also be
given to representation by a medical advisor. The structure for the management of
biological safety issues within each facility should be determined locally and will
vary according to the level of coordination and the associated resources necessary
for implementation.
The determining factors include the size of the facility (staff and square footage),
concentration of multiple laboratories in the facility, containment levels within the
facility (level 2 laboratory, multiple level 3 laboratories), complexity of the processes
(routine diagnostics, research, large scale, recombinant work), existence of shared
laboratory space within the facility (multiple investigators, various organizations)
and experimental or diagnostic animal activities within the facility.
Biological safety issues to be managed may include the following:
P Identifying training needs and assisting with the development and
delivery of biosafety training programs, such as general biosafety, BSC
use, animal biosafety, staff orientation and containment suite training.
P Performing risk assessments when required and developing
recommendations for procedural or physical laboratory modifications.
P Auditing the effectiveness of the biosafety program and its associated
management system on a regular basis.
P Participating in accident investigations and promoting the reporting of
incidents within the facility or laboratory.
P Distributing new and relevant biosafety information to laboratory staff and
maintaining liaison with support staff, housekeeping staff and contractors
on matters related to facility biosafety.
P Coordinating and monitoring the decontamination, disinfection and
disposal procedures for infectious materials in the facility or laboratory
and coordinating emergency response activities.
P Coordinating the receipt, shipment and transport within the facility of
infectious material according to the Workplace Hazardous Materials
Information System (WHMIS) and Transportation of Dangerous Goods
(TDG) regulations.
P Establishing a record keeping and secure storage system for all infectious
material entering the facility.
Containment Level 3/4 laboratories may have the additional biosafety
activities:
P Certification and recertification of the laboratory.
P Investigation and remediation of containment suite physical or operational
failures.
P Access control to the containment suites.
P Liaison with applicable regulatory bodies, such as DBT, GEAC, RDAC.
Intellectual Property Rights (IPR), Biosafety and Bioethics | 549

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