This document discusses various aspects of biodiversity law in India. It provides definitions of key terms like genetic biodiversity, species biodiversity, and ecosystem diversity. It also summarizes sections of the Indian Biodiversity Act of 2002 regarding obtaining approval for accessing biological resources and associated traditional knowledge, as well as for applying for intellectual property rights. The document notes the requirements for benefit sharing and obtaining permission to transfer biological material or knowledge.

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Opportunities and Challenges for the Industry and Stakeholders
R. Muralidharan
Advocate, Law Lecturer
Patent & Trademark Attorney

2. 25-27th March 2017. 10/17/2017Murali
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3. R. Muralidharan
Advocate, Patent Agent
Law Lecturer, Mediator
Mobile:-0-94482 47549
mailto: muralimanu@gmail.com/
advrmuralidharan@gmail.com
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Biological diversity means and
includes all the flora and fauna
present in the environment ,their
genes and the geo ecosystem in
which the flora and fauna are
present.

5. The term biodiversity started
appearing in the international
media during the 1980s.It was
essential to understand and
preserve biodiversity in order
to ensure sustainable
development, agricultural
productivity , fishing and other
animal husbandry activities.
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6.  The present Biodiversity can be attributed to
the never ending process of evolution. The
process is as old as our planet . Originally the
planet was full of blue-green algae that
gradually increased the oxygen content in the
air to the present level of 16%. It is the
increased oxygen content which made life
possible on earth. Once life originated (either
due to an act of god or unique geological
situations), the process of evolution began.
Somewhere down the line , life manifested in
different forms, namely ,plants, animals ,
micro-organism ,virus etc. Thereafter, the
process of evolution was in full bloom. The
Biodiversity we have today is due to this
process.
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7. WHAT IS EVOLUTION?
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The systematic study of evolution began during the 16th
and 17th centuries. Lamarckian hypothesis stated that
when some tissues and organs are used more ,they will
change ,ensuring that the functions performed by these
tissues and organs are modified over a period of time. This
is called a variation. When the variation is heritable then it
becomes a mutation. Mutations over a period of time have
resulted in the diversity of species and diversity within the
species itself.

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9. 1. Variation among species.
2. Prodigality of production.
3. Struggle for existence.
4. Survival of the fittest.
Thus the Biodiversity we have today is the
cumulative result of the process of evolution
that has occurred over tens of thousands of
years.
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10. 1. Genetic Biodiversity.
2. Species Biodiversity
3. Ecosystem Diversity
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Concerns the variations and types of
genes present in the chromosome of
different species. Understanding
genetic Biodiversity enables one to
improve the desired qualities a species
and facilitates the evolution of a new
species. Enables adapted organisms to
cope with the changes in
environmental conditions. It is very
crucial for agricultural productivity
which includes animal husbandry and
fish farming.

12. SPECIES
BIODIVERSITY
 Concerns the variety of
flora and fauna in terms of
number and the variations
within the species in a given
region. When a species is
confined entirely to a
particular area it is called
an endemic species. E.g.
Kangaroo in Australia. Emu
in New Zealand.
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13.  Deals with the
variations that a
species develops over a
period of time because
of the physical
environment in which
they live . The
ecosystem diversity
enables biological
communities to
tolerate different types
of stress such as
drought, flood
,warming, cooling etc.
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14. South China Tiger((Panthera tigris amoyensis)
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Bengal Tiger (Panthera tigris tigris)
Siberian Tiger. (Panthera tigris altaica)
Siberian Tiger. (Panthera tigris altaica

15. 10/17/2017Murali 15Malayan Tiger (Panthera tigris jacksoni)
Sumatran Tiger (Panthera tigris sumatrae)
Javan Tiger (Panthera tigris sondaica)

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Caspian Tiger (Panthera tigris virgata)
Indo Chinese (Panthera tigris corbetti)
Golden Tabby Tigers

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Kesar – Saurashtra, Gujarat
Dasheri -Malihabad, Uttar Pradesh
Alphonsos -Ratnagiri, Maharashtra

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Nendran
Rasakadali

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Manthan
Poovan

20. TO
BIODIVERSITY?
1. Habitat destruction
2. Habitat fragmentation
3. Pollution
4. Over exploitation
5. Introduction of alien species.
6. Disease
7. Shifting or jhum cultivation
8. Poaching of wildlife.
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The state of Florida, America, is having a problem with increasing number of Burmese Pythons in
the area. Burmese Pythons are not native to Florida but they started showing up in the
Everglades in the 1980s, probably after the release or escape of exotic pet snakes
http://www.sbs.com.au/yourlanguage/punjabi/en/article/2017/02/08/indian-snake-hunters-hired-florida-us-catch-pythons
Introduction of alien species.

23.  Sometimes the knowledge of the indigenous
people about the flora and fauna endemic to the
region is used by others for profit without
permission (earlier such permission were
unnecessary), or without compensation or even
recognition to the indigenous people themselves.
Organisations such as Greenpeace claim that
these practices enhance the prevailing
inequality between the developing countries that
are Biodiversity rich and the developed
countries which are not so rich biologically , but
have big companies that understand the various
aspects of biology .
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24.  Rosy Periwinkle, a herb, was endemic only to Madagascar.It was
taken to many countries during the 1950s. People knew it had
medicinal value. But nobody knew which substance in the plant
gave the plant its beneficial curative properties. Vincristine sold
under the brand name Oncovin is extracted form this plant and used
to treat different types of cancer and even Hodgkin’s disease.
 Enola bean . The Enola bean is a variety of Mexican yellow bean
named after the wife of a person who patented it in the USA.
Traditionally ,more than 20,000 Mexican farmers were exporting
this yellow bean to the US market. After patenting, they were
injuncted from selling their produce .
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27.  In Form- 1 serial no. 9 talks about Declarations.
 Serial No. 9 (III) sub-point (iii) states,
“The invention as disclosed in the specification uses the
biological material from India and the necessary
permission from competent authority shall be submitted
by me/us before the grant of patent to me/us.”
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28.  According to Rule 14, of Biodiversity Rules, 2003:
(1) any person seeking approval of Authority for
access to biological resources and associated
knowledge for research or for commercial utilization
shall make an application in Form-1.
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Sec 3 of Biodiversity Act, 2002
3. (1) No person referred to in sub section (2) shall, without previous approval of the National
Biodiversity Authority, obtain any biological resource occurring in India or knowledge associated
thereto for research or for commercial utilization or for bio survey and bio utilization.
(2) The persons who shall be required to take the approval of the National Biodiversity Authority
under sub section (1) are the following, namely:
(a) a person who is not a citizen of India;
(b) a citizen of India, who is a non resident as defined in clause (30) of section 2 of the Income tax
Act, 196 1;
(c) a body corporate, association or organization-
(i) not incorporated or registered in India; or
(ii) incorporated or registered in India under any law for the time being in force which has any
non Indian participation in its share capital or management.
Results of research not to be transferred to certain persons without approval of National
Biodiversity Authority

31.  Sec-6 mandates for taking the permission before applying for
Intellectual property right. It states as follows-:
 6.(1) No person shall apply for any intellectual property right, by whatever
name called, in or outside India for any invention based on any research or
information on a biological resource obtained from India without obtaining
the previous approval of the National Biodiversity Authority before making
such application.
 Provided that if a person applies for a patent, permission of the National
Biodiversity Authority may be obtained after the acceptance of the patent
but before the sealing of the patent by the patent authority concerned:
Provided further that the National Biodiversity Authority shall dispose of
the application for permission made to it within a period of ninety days from
the date of receipt thereof.
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33.  Obtain Permission for Biological Resources for
commercial use.
Transferring of Biological Material.
Transferring of Biological Resource or Knowledge.
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34. Sec 9 talks about prior approval needed to obtain biological
resource in India for commercial use. It states as follows-:
 19.(1) Any person referred. to in sub section (2) of section 3 who intends to
obtain any biological resource occurring in India or knowledge associated
thereto for research or for commercial utilization or for bio survey and bio
utilization or transfer the results of any research relating to biological
resources occurring in, or obtained from, India, shall make application in
such form and payment of such fees as may be prescribed, to the National
Biodiversity Authority.
(2) Any person who intends to apply for a patent or any other form of
intellectual property protection whether in India or outside India referred
to in sub section (1) of section 6, may make an application in such form and
in such manner as may be prescribed to the National Biodiversity
Authority.
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36.  Section 20 talks about Transferring of Biological resources and
Knowledge-:
 20.(1) No person who has been granted approval under section 19 shall
transfer any biological resource or knowledge associated thereto which is
the subject matter of the said approval except with the permission of the
National Biodiversity Authority.
 (2) Any person who intends to transfer any biological resource or
knowledge associated thereto referred to in sub section (1) shall make an
application in such form and in such manner as may be prescribed to the
National Biodiversity Authority.
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37.  Sec 19 Any person referred to in sub-section (2) of
section 3 who intends to obtain any biological
resource occurring in India or knowledge
associated thereto for research or for commercial
utilization or for Bio survey and bio-utilization or
transfer the results of any research relating to
biological resources occurring in, or obtained from,
India, shall make an application in such form and
payment of such fees as may be prescribed, to the
National Biodiversity Authority. 10/17/2017
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38.  Sec 6 6.(1) No person shall apply for any intellectual property right,
by whatever name called, in or outside India for any invention based
on any research or information on a biological resource obtained
from India without obtaining the previous approval of the National
Biodiversity Authority before making such application.
 Provided that if a person applies for a patent, permission of the
National Biodiversity Authority may be obtained after the
acceptance of the patent but before the sealing of the patent by the
patent authority concerned:
 Provided further that the National Biodiversity Authority shall
dispose of the application for permission made to it within a period
of ninety days from the date of receipt thereof.
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39.  Sec 19 sub clause (2) talks about applying for IPR
in Biodiversity Act, 2002
Any person who intends to apply for a patent or
any other form of intellectual property protection
whether in India or outside India referred to in sub
section (1) of section 6, may make an application in
such form and in such manner as may be
prescribed to the National Biodiversity Authority.
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41. Biodiversity Rule 18 talks about applying for IPR
 Procedure for seeking prior approval before applying for
intellectual property protection. -
Any person desirous of applying for a patent or any other
intellectual property based on research on biological
material and knowledge obtained from India shall make
an application in Form III.
Every application under sub-rule (1) shall be accompanied
by paying a fee of five hundred rupees.
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43. The Authority after due appraisal of the application
and after collecting any additional information, on the
basis of merit shall decide on the application, as far as
possible within a period of three months of receipt of
the same.
On being satisfied that the applicant has fulfilled all
the necessary requirements, the Authority may grant
approval for applying for a patent or any other IPR
subject to such terms and conditions as it may deem fit
to impose in each case.
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44. The approval shall be granted in the form of a
written agreement duly signed by an authorized
officer of the Authority and the applicant. The form
of the agreement may be decided by the Authority.
The Authority may reject the application if it
considers that the request cannot be acceded to
after recording the reasons. Before passing order of
rejection, the applicant shall be given an
opportunity of hearing.
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46.  Rule 16 gives the terms and guidelines on restrictions on obtaining biological
material. The restrictions are as follows:-
 The Authority if it deems necessary and appropriate shall take the steps to
restrict or prohibit the request for access to biological resources for the
following reasons ; namely :-
 the request for access is for any endangered taxa ;
 the request for access is for any endemic and rare species;
 the request for access may likely to result in adverse effect on the livelihoods
of the local people;
 the request to access may result in adverse environmental impact which may
be difficult to control and mitigate;
 the request for access may cause genetic erosion or affecting the ecosystem
function;
 use of resources for purposes contrary to national interest and other related
international agreements entered into by India.
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48.  Under Biodiversity Act there is a concept
called benefit sharing where the Biodiversity
Board shares the benefit with the inventor
after giving them the permission
There are many sections in the act laid down
for the same. The Rules of biodiversity also
lays down the rules for the royalty/benefit
sharing.
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49. Sec-2 sub clause (2) The National Biodiversity
Authority may, while granting the approval under
this section, impose benefit sharing fee or royalty
or both or impose conditions including the sharing
of financial benefits arising out of the commercial
utilization of such rights.
 Sec 2(2) gives an insight about the benefit sharing
imposed by the board.
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50.  Sec 19 sub-clause (2) lays down as follows-:
 On receipt of an application under sub section (1) or sub section (2),
the National Biodiversity Authority may, after making such enquiries
as it may deem fit and if necessary after consulting an expert
committee constituted for this purpose, by order, grant approval subject
to any regulations made in this behalf and subject to such terms and
conditions as it may deem fit, including the imposition of charges by
way of royalty or for reasons to be recorded in writing, reject the
application:
 Provided that no such order for rejection shall be made without giving
an opportunity of being heard to the person affected.
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52.  Sec 21 lays down terms and guidelines for the imposition of
royalty/benefit sharing which is as follows-:
 1.(1) The National Biodiversity Authority shall while granting
approvals under section 19 or section 20 ensure that the terms and
conditions subject to which approval is granted secures equitable
sharing of benefits arising out of the use of accessed biological
resources, their by products, innovations and practices associated
with their use and applications and knowledge relating thereto in
accordance with mutually agreed terms and conditions between the
person applying for such approval, local bodies concerned and the
benefit claimers.
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53. (2) The National Biodiversity Authority shall,
subject to any regulations made in this behalf,
determine the benefit sharing which shall be given
effect in all or any of the following manner, namely:
setting up of venture capital fund for aiding the
cause of benefit claimers;
payment of monetary compensation and non
monetary benefits to the benefit claimers as the
National Biodiversity Authority may deem fit.
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54. grant of joint ownership of intellectual property rights to
the National Biodiversity Authority, or where benefit
claimers are identified, to such benefit claimers;
transfer of technology;
location of production, research and development units in
such areas which will facilitate better living standards to
the benefit claimers;
association of Indian scientists, benefit claimers and the
local people with research and development in biological
resources and bio survey and bio utilization;
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55. 3) Where any amount of money is ordered by way of benefit
sharing, the National Biodiversity Authority may direct the
amount to be deposited in the National Biodiversity Fund:
. Provided that where biological resource or knowledge was a
result of access from specific individual or group of
individuals or organizations, the National Biodiversity
Authority may direct that the amount shall be paid directly
to such individual or group of individuals or organizations in
accordance with the terms of any agreement and in such
manner as it deems fit
(4) For the purposes of this section, the National Biodiversity
Authority shall, in consultation with the Central Government,
by regulations, frame guidelines.
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57. Rule 20 is read with Sec 21 for Equitable Benefit Sharing
which lays downs following conditions-:
20. Criteria for equitable benefit sharing (Section 21)
The Authority shall by notification in the Official Gazette
formulate the guidelines and describe the benefit sharing
formula.
The guidelines shall provide for monetary and other
benefits such as royalty; joint ventures; technology
transfer; product development; education and awareness
raising activities; institutional capacity building and
venture capital fund.
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58. The formula for benefit sharing shall be determined on a
case-by case basis.
The Authority while granting approval to any person for
access or for transfer of results of research or applying for
patent and IPR or for third party transfer of the accessed
biological resource and associated knowledge may impose
terms and conditions for ensuring equitable sharing of the
benefits arising out of the use of accessed biological
material and associated knowledge.
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60.  The quantum of benefits shall be mutually agreed upon between the
persons applying for such approval and the Authority in
consultation with the local bodies and benefit claimers and may be
decided in due regard to the defined parameters of access, the extent
of use, the sustainability aspect, impact and expected outcome
levels, including measures ensuring conservation and sustainable
use of biological diversity.
 Depending upon each case, the Authority shall stipulate the time
frame for assessing benefit sharing on short, medium, and long term
benefits.
 The Authority shall stipulate that benefits shall ensure conservation
and sustainable use of biological diversity.
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61.  Where biological resources or knowledge is accessed from a specific
individual or a group of individuals or organizations, the Authority
may take steps to ensure that the agreed amount is paid directly to
them through the district administration. Where such individuals or
group of individuals or organizations cannot be identified, the
monetary benefits shall be deposited in the National Biodiversity
Fund.
 Five percent of the assessed benefits shall be earmarked for the
Authority or Board as the case may be , towards administrative and
service charges.
 The Authority shall monitor the flow of benefits as determined
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63. Rule 14 clause 2 details out the fee structure that
is Every application under sub-rule (1) shall be
accompanied by a fee of ten thousand rupees in the
form of a Cheque or demand draft drawn in favour
of the Authority.
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65. Rule 14 sub clause 3 lays down the time required
for the completion of the process of making an
application which is stated as follows-:
“The Authority shall after consultation with the
concerned local bodies and collecting such
additional information from the applicant and
other sources, as it may deem necessary, dispose of
the application, as far as possible, within a period
of six months from the date of its receipts.”
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67. Sec52 A of the Biodiversity Act,2002 lays down the process for Appeal to National
Green Tribunal.
Any person aggrieved by any determination of benefit sharing or
order of the National Biodiversity Authority or a State Biodiversity
Board under this Act, on or after the commencement of the
National Green Tribunal Act, 2010 (19 of 2010), may file an appeal
to the National Green Tribunal establishment under section 3 of
the National Green Tribunal Act, 2010, in accordance with the
provisions of that Act.
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68. Under sec 54 No suit can be filed against the Board for
any decision taken in a good faith.
Under sec 55 penalties are as follows-:
Any contravention of sec 3,4 or 6 is punishable with
imprisonment for term which may exceed 5 years and fine
which may extend to 10 lakhs.
Any contravention of Sec 7 or sub sec (2) of sec 24 shall be
punishable with imprisonment for a term which may
extend for 3 years and fine which may extend to 5 lakh.
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69. Sec 56 lays down the penalty for contravention of directions
and orders of concerned authority which states as follows, “If
any person contravenes any direction given or order made by
the Central Government, the State Government, the National
Biodiversity Authority or the State Biodiversity Board for
which no punishment has been separately provided under this
Act, he shall be punished with a fine which may extend to one
lakh rupees and in case of a second or subsequent offence,
with fine which may extend to two lakh rupees and in the case
of continuous contravention with additional fine which may
extend to two lakh rupees everyday during which the default
continues.
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70. An Indian National resident in India comes up with a novel
industrial process to extract the active ingredients Stigmasterol
and Hecogenin from Vitro Root cultures of Chlorophytum
Borivilianum (Safed Musli).
This process contemplates inducing Polyploidy in a normal Safed
Musli plant by known processes using known chemicals. This
induced polyploidy increases the above active ingredients content
by more than 10% and contemplates green houses to make root
cultures available throughout the year. Should permission from
Biodiversity Authority needed in above scenario? (Application No.
E/2/2800/2014CHE)
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72. Mannargudi Venkatrama Iyer, an orthodox South
Indian carried with him gingelly seeds and holy
grass to Singapore when he settled on with his
grown up son. The son also had a biotechnologist
daughter. During auspicious days, M.V. Iyer
performed “Tharpana” in the potted plants. Due to
natural factors, the gingelly seeds offered in
“Tharpana” became fully grown up plants from
which his granddaughter harvested all the seeds.
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74. She, Singapore national by birth yet holding PIO
card and visiting India regularly used the seed to
produce a new variety which will have a very high
content of unsaturated low fat acids. This becomes
the subject matter of new plant variety application
and, plant and process patents around the world
including India. They have not obtained the
permission from BDA and the inventor repudiates
any legal application. Who will you prosecute? Mr.
Iyer or his grandaughter? 10/17/2017Murali 74

75. A scientist from Indian Council of Horticulture
Research goes on deputation to Philippines and
thereafter to Mombasa in Africa. He collects two
mango varieties which were peculiar to these
regions and brings it home, to India. He continued
to carry on experiments and combines Philippine
and Mombasa mango plants in India and evolved a
new variety. After retiring from his job he notifies
the foreign research institutes from which he
obtained the mango seeds. 10/17/2017Murali 75

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77. These two institutes made a joint application
abroad and followed it up with process and plant
patent and new plant variety registration in India.
The Indian scientist has been named as an
inventor. Is it necessary to obtain permission from
BDA for transferring findings and sharing genetic
material with foreigners?
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78. The invention contemplates an anaerobic digester
for treating organic waste to produce combustible
gas. The invention employs different mechanical
parts and assemblies to facilitate quicker
decomposition besides producing gas. The organic
waste used can be paddy husk brickets, in which
case it will give an end product of silica.
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79. If coconut shells and husk is used, it gives
activated charcoal. Besides the invention applies
many naturally occurring bacteria to facilitate
digestion of the organic waste. Would the inventor
seek permission from BDA because it employs
organic waste (Is it a biological material?)And the
naturally occurring bacteria?
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80. Sec 2(c) defines Biological resources as
"plants, animals and micro-organisms or
parts thereof, their genetic material and
by-products (excluding value added
products) with actual or potential use or
value, but does not include human
genetic material.
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81. This presentation is primary meant for
instructional use. Not for Publication.
The ownership of the TM & copyrighted
material (especially cartoons) appearing
in the presentation is acknowledged.
Thanks to the
Cartoonists/Photographers, a dull
presentation receives an interesting
touch.
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