DR.

RAM MANOHAR LOHIYA NATIONAL

LAW UNIVERSITY

2019-2020
Final draft of:
FARMERS AND BREEDERS RIGHT
Biotechnology and Protection of Intellectual Property

Submitted to:- Submitted by:-

Bhanu Pratap Singh Ayushi Verma
Asst.professor Section –A
Rmlnlu Enrollment no.-35
Semester IX

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ACKNOWLEDGMENT:

I would like to express my heartfelt gratitude to my teacher and mentor

Bhanu Pratap Singh (assistant professor), a special thanks to the Vice
Chancellor of Dr. Ram Manohar Lohiya National Law University, Dr.
Sukhbeer K. Bhatnagar for providing me with this opportunity. I also greatly
acknowledge the help and guidance provided to me by Prof. C.M. Jariwala
(Dean Academics).

Thanks and appreciation to my family members for their constant

support, to the library staff and other members of this institution and lastly to
my friends for their help.

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TABLE OF CONTENTS:

1- Introduction

2- Structure of the industry

3- What is GST?

4- Impact of GST on leather industry

5- Conclusion

6- References

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INTRODUCTION

India is emerging a strong contender in international trade in the field of biotechnology.

Since research and development (R&D) in biotechnology is extremely time consuming
and requires high investments in production and marketing besides skilled human
resources, granting Intellectual Property Rights (IPR) is an effective tool to protect
biotechnology inventions. Protection of new life forms by enforcing IPRs raises a number
of difficult technical and ethical issues in developing countries like India. Indians have
considerable problems fixing monetary value to anything that is not a tangible physical
property. But now attitudes of people are changing. Therefore there is an urgent need to
develop IPR regimes which are specifically tailored, respecting the peoples’ priorities.
Intellectual property rights (IPR) are also important internationally in public, non -profit
and private institutions, both as incentives for innovation and as constraints on freedom to
operate in R&D in plant biotechnology. This paper reviews the challenges and
implications of enforcing and strengthening Intellectual Property Rights (IPRs) and
intellectual patent regimes in plant biotechnology. The establishment of IPRs increases
welfare in society by guaranteeing food security for future and protecting interests of
inventors. At the same time enforcing stringent intellectual property regimes not
conforming to national interests, offers a type of monopoly for the commercial
exploitation of an innovation. The monopoly may however disadvantage particular
stakeholders. Therefore implementation of IPRs based on national laws should be
accompanied by measures which foster innovation and expand trade as well as maintain
balance of economic interests of different stakeholder in society.

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INTELLECTUAL PROPERTY AND BIOTECHNOLOGY

Intellectual property refers to creations of the mind: inventions, literary and artistic
works, and symbols, names, images, and designs used in commerce. Intellectual Property
includes industrial property i.e. inventions (patents), trademarks, industrial designs, and
geographic indications of source; and Copyright, which includes literary and artistic
works such as novels, poems and plays, films, musical works, artistic works such as
drawings, paintings, photographs and sculptures, and architectural designs.

In recent years, instruments enforcing intellectual property rights (IPRs), such as patents
and trade secrets, have received attention as mechanisms by which biodiversity resources
may be maintained while promoting sustainable development and a more equitable
distribution of the resulting benefits among nations. Most of the world’s biodiversity-rich
countries are underdeveloped and lack the necessary technologies to transform biological
resources into products yielding significant measurable benefits. With little or
insignificant in situ market value, biodiversity-rich wild lands may be expected to
succumb to pressure from development activities (e.g., conversion to cropland,
inundation of forest lands due to hydroelectric and flood-control projects, etc.)

One way to prevent the destruction of wild lands (and, in turn, biodiversity loss) is to
promote biodiversity prospecting which creates new markets for biological resources and
generates incentives for their conservation. However, biodiversity prospectors generally
are multinational corporations from developed countries. These corporations are reluctant
to invest in biotechnologies discovered in developing countries due to poorly defined and
enforced intellectual property laws. BD establishes a formal framework for the reciprocal
transfer of biological resources and knowledge (technology) between nations. The
convention promotes the idea of biodiversity as a global common heritage, which,
therefore, requires biodiversity rich countries to allow access to biological resources to
other countries on ‘mutually agreed terms’ (UN, 1993). Nations which have become
signatories of two major international agreements in recent years: the 1992 Convention

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on Biological Diversity (CBD) (UNEP, 1992) and the 1993 Trade-Related Intellectual
Property Rights (TRIPS) (UN, 1993).

INDIAN REGIME

THE GOVERNMENT POLICIES IN PATENTING:

The Ministry of Science and Technology has issued the guidelines “Instructions for
Technology Transfer and Intellectual Property Rights”, which would help in enhancing
the motivation of scientists, research institutions and universities in various research and
development projects funded by various departments of the Ministry of Science and
Technology. The salient features of these guidelines are as follows:

1. Ownership of Intellectual Property:

The institution shall be encouraged to seek protection of IPR rights in respect of the
results of R&D. They may retain the ownership of such IPRs. Institutions would mean
any technical, scientific or academic establishment where the research is carried through
funding by Central/State Governments.

2. Transfer of Technology:
The institutions would take necessary steps to commercially exploit patents on exclusive
or non-exclusive basis.

3. Royalty to inventors:
The owner institutions are permitted to retain the benefits and earnings generated out of
the IPR. The institution may determine the share of inventors and other associated
persons from such earnings. However, such shares shall be limited to one third of the
actual earnings.

4. Norms for the private industry:

IPR generated through joint research by institution(s) and industrial concern(s) through
joint research efforts can be owned jointly by them on mutually agreed terms through a

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written agreement. The institution and industrial concern may transfer the technology to a
third party for commercialisation on exclusive or non-exclusive basis. The third party,
exclusively licensed to market the innovations in India, must manufacture the product in
India. The joint owners may share the benefits and earnings arising out of commercial
exploitation of the IPR.

5. Patent Facilitating Fund:

The owner institution(s) shall set apart no less than 25 per cent of the revenues generated
from IPR to create a patent facilitating fund. The fund shall be utilised by the owner for
updating the invention(s), filing new patents and protecting the IPR against infringement
and for building competency in the area of IPR and related issues.

BIOSAFETY PROCEDURES IN INDIA

India has acceded to the Biosafety Protocol on 17th January 2003.

1. GMOs are regulated in India under the purview of the 1986 Indian Environment
(Protection) Act.
2. Ministry of Environment and Forests has notified the Rules for the Manufacture, Use,
Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered
Organisms or Cells under this act.
3. Presently, there are six competent authorities:
i) Recombinant DNA Advisory Committee (RDAC),
ii) Institutional Biosafety Committees (IBSC), IBSC oversees the researches and to
interface with the RCGM in regulating it.
iii) Review Committee on Genetic Manipulation (RCGM)
RCGM established under the Department of Biotechnology supervises research
activities including small scale field trials
iv) Genetic Engineering Approval Committee (GEAC), GEAC, established under the
Ministry of Environment and Forests gives approvals for large scale releases and
commercialization of GMOs.

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v) State Biotechnology Coordination Committee (SBCC)
vi) The District Level Committee (DLC)
• Bt. Cotton is the first and only transgenic crop approved by GEAC for commercial
cultivation in 6 States namely Andhra Pradesh, Gujarat, Karnataka, Madhya Pradesh,
Maharashtra and Tamil Nadu.

LEGISLATIVE FRAMEWORK & THE ETHICAL ISSUE

• TRIPS excludes biological processes for the production of plants or animals as a

patentable subject matter, but patents can be granted to the microorganisms,
nonbiological, and microbiological processes used in the production of plants and
animals.
• IPR protection is granted only for invention and not for discoveries.
• In biotechnology innovations, it is difficult to say whether the new life form in the form
of gene, DNA, cell etc. is a scientific discovery or a technological invention.
• Consideration of industrial application is yet another obstacle for securing patents for
inventions in biotechnology. However, in India there are several ethical issues too
related to patenting of life forms, the most important being extent of private ownership
that could be extended to life forms.
• Idea of profit making by exploiting any common heritage of civilization or culture is
unacceptable to lots of people and communities.
• Hence, there is an urgent need for developing countries like India to define clear
policies for IPR in case of scientific and technological innovations.

1. Trait-Genetic Use Restriction Technology (T-GURT)

• New trait-genetic use restriction technology (T-GURT) is being employed as a part of
biotechnology by means of terminator and traitor genes.
• It restricts unauthorized copying of patents and monopoly in the international
marketing. But farmers cannot save seeds of their crops at the end of the crop season.
It may therefore pose a potential threat to our food security. (CGIAR) has decided not
to incorporate T-GURT in forthcoming plant breeding programs of international

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institutions.
2. Indian Proprietary Agricultural Technology Profile
• ICAR is the IP leader with over 60 granted patents in the field of plant and animals
sciences, including biotechnology, diary technology, animal disease diagnostics, and
therapeutics, engineering and post harvest processing, and environmental science.
• Other patentees in agriculture include universities, IITs, and other research
organizations like CSIR, DRDO etc.
3. A few patents have been granted to individual inventors for inventions such as:
• An improved agriculture harrow disk, Tractor mounted multipurpose deep trencher, a
preparation for enhancing yield in agriculture and horticulture, a composition for
enhancing nitrogen fixation in legumes etc.
4. According to the Indian Patent Act 1970 and subsequent amendments, patents could
be applied mainly for agricultural tools and machinery or the processes for the
development of agricultural chemicals
• Any new plant variety, arising out of an innovative use of conventional techniques or
modern biotechnological methods, is not patentable subject matter.
5. Since 2005 inventions related to agrochemicals as products could be patented
according to the Patent (Amendments) Act, 2005.
6. Convention on Biological Diversity (CBD), 1993
• A multinational treaty which expressly provided for the rights of indigenous
communities (Article 8 (i) of the CBD), and the International Undertaking on Plant
Genetic Resources (IUPGR) has provided defined farmers’ rights (CBD 1994, FAO
1983) inter alia affirm that “the past, present and future contributions of farmers in
conserving, improving and making available the genetic resources is the basis of farmer’s
rights”.
• The Convention has three main goals:
a) conservation of biological diversity (or biodiversity);
b) sustainable use of its components; and
c) fair and equitable sharing of benefits arising from genetic resources.
• The Convention was opened for signature at the Earth Summit in Rio de Janeiro on 5
June 1992 and entered into force on 29 December 1993

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• The year 2010 was the International Year of Biodiversity
• Importantly, the Convention is legally binding; countries that join it ('Parties') are
obliged to implement its provisions.

7. Cartagena Protocol on Biosafety

• Supplementary agreement adopted by CBD on 29 January 2000.
• The protocol became international law in September 2003 and has since been
ratified by more than 100 countries excluding USA.
• India has acceded to the Biosafety Protocol on 17th January 2003.
• The Protocol seeks to protect from the potential risks posed by Living Modified
Organisms (LMOs) resulting from modern biotechnology intended for direct use
for food, feed or processing.
• It incorporates procedure for import of LMOs with respect to Food, Feed and
Product.
• Risk Management : Risk management measures include food labeling, conditions
on marketing approvals, post marketing monitoring and development of methods to
detect or identify foods derived from modern biotechnology.

8. Nagoya Protocol
• Supplementary agreement to the CBD
• Adopted at the 2010, 10th Conference of Parties (COP) to the CBD on 29th October
in Nagoya, Japan and enter into force on 12 October 2014.
• It has been ratified by 53 states and the European Union.
• On 22 December 2010, the UN declared the period from 2011 to 2020 as the UNDecade
on Biodiversity.
• It provides a transparent legal framework for the effective implementation of one of the
three objectives of the CBD: the fair and equitable sharing of benefits arising out of the
utilization of genetic resources thereby contributing to the conservation and sustainable
use of biodiversity.
• The Nagoya Protocol applies to genetic resources that are covered by the CBD, and to
the benefits arising from their utilization.

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9. International Treaty on Plant Genetic Resources for Food and Agriculture
(ITPGRFA)
• Popularly known as the International Seed Treaty, it is a comprehensive
international agreement in harmony with the Convention on Biological Diversity,
which aims at guaranteeing food security through the conservation, exchange and
sustainable use of the world's plant genetic resources for food and agriculture
(PGRFA), as well as the fair and equitable benefit sharing arising from its use.
• The treaty has implemented a Multilateral System (MLS) of access and benefit
sharing, among those 64 countries that ratify the treaty, of some of the most
important food and forage crops essential for food security and interdependence.
• Basic function is to promote the full implementation of the Treaty, including the
provision of policy guidance on the implementation of the Treaty
• Governing Body elects its Chairperson and Vice- Chairpersons, in conformity
with its Rules of Procedure. They are collectively referred to as "the Bureau".
10. National Biodiversity Authority (NBA)
• NBA is a statutory autonomous body under the MoEF, Govt of India established in
2003 to implement the provisions under the National Biological Diversity Act,
2002, after India signed CBD in 1992.
• In 2012, NBA organized the first ever National Biodiversity Congress (NBC) at
Thiruvananthapuram, Kerala. • NBA with its headquarters in Chennai, Tamil Nadu,
delivers its mandate through a structure that comprises of the Authority, Secretariat,
SBBs, BMCs and Expert Committees.
• Status of India’s Biodiversity Accounts for 7-8 per cent of the recorded species of
the world One of the 17-mega biodiversity countries 46,000 species of plants and 81,000
species of animals have been recorded. Acknowledged centre of crop diversity Harbors
many wild relatives and breeds of domesticated animals and fish Millions of microbial
diversity, insects and other species.

11. The Protection of Plant Varieties and Famer‘s Rights Act, 2001, (PPVFRA), is
one of the principal legislations drafted in consonance with the provisions of the

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Agreement on Trade-Related Intellectual Property Rights (TRIPS), dealing with a sui
generic system of protection of plant and crop varieties in the country.
12. The sui generis legislation approved by both houses of the Indian parliament on 23rd
December, 1999 and was named as the Geographical Indications of Goods
(Registration & Protection) Bill, 1999.
13. Seeds Act, 1996, enacted so as to regulate and control the quality of seeds and for any
matters connected therewith.
14. Plants Fruits and Seeds (Regulation of Import into India) Order , 2003, now has
been replaced by the Plant Quarantine (Regulation Of Import Into India) Order, 2003,
and aims at prohibiting and regulating the import of the listed agricultural products into
India.

IPR ISSUES IN BIOTECHNOLOGY

The challenges for enforcing IPR strictly lie in nature of plant varieties and their
production tools and procedures.
1. R & D in biotechnology is extremely time consuming and requires huge investment.
2. There are, however, no internationally accepted guidelines for the management of IPR.
3. They are biological products that are easily reproduced and whose very use entails
multiplication.
4. The users of the technology are dispersed geographically in wider areas whose
compliance with any protection regime is difficult and expensive to monitor.
5. The agricultural sector involves cultural values and food security affecting the
livelihoods of the rural poor in country like India.
6. The development of new plant varieties has always relied to some extent on public
research hence the application of IPRs to the products of a publicly funded endeavour
offers problems.
7. The advent of modern biotechnology has brought additional challenges for the
application of IPRs in plant breeding. Majority of the tools and processes of genetic
transformation are patented and many of the techniques of biotechnology extensively
used in conventional plant breeding are also protected, raising implications for the

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ownership of any variety resulting from such research.

SOME RECENT DEVELOPMENTS

• In 2003, TK-1 (GloFish) went on sale in Taiwan, as the first genetically modified pet.
• In 2006, the artist Stelarc had an ear grown in a vat and grafted onto his arm.
• In 2009, Sasaki and Okana produced transgenic marmosets that glow green in
ultraviolet light — and pass the trait to their offspring.
• In 2010, scientists created malaria-resistant mosquitoes.
• In 2010, the Craig Venter Institute produced an “artificial” microorganism.

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CONCLUSION

India is emerging a strong contender in international trade in the field of biotechnology.

The significant factors contributing towards India’s biotechnology potential are the
highly skilled human resources , technical resources and rich biodiversity of the country.
India has a wider scope for the utilization and the implementation of its resources because
of cost competitive manpower, well developed and integrated scientific infrastructure. It
is largest producer of low cost and high quality bulk biotech products and services which
holds a promising market. The need for food security and bio safety, better achieved in a
competitive market, has to be balanced with the protection of inventive rights of the
inventor through frameworks for protection of intellectual property rights. The
establishment of IPR increases welfare in society by guaranteeing food security for future
and protecting interests of inventors. At the same time enforcing stringent intellectual
property regimes not conforming to national interests offers a type of monopoly for the
commercial exploitation of an innovation. The monopoly may however disadvantage
particular stakeholders. Therefore, implementation of IPR based on national laws should
be accompanied by measures which foster innovation and expand trade as well as
maintain balance of economic interests of different stakeholders in society. While some
of the measures can be addressed through multilateral forums, many of them should be
addressed through specifically tailored domestic laws and policies.

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REFERNCES

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