NATIONAL UNIVERSITY ODISHA , CUTTACK

INTELLECTUAL PROPERTY RIGHTS

TOPIC - BIOTECHNOLOGY AND PROTECTION OF

INTELLECTUAL PROPERTY
SEMESTER - VI

SUBMITTED TO : SUBMITTED BY :
DR. DIVYA SINGH RATHOR PARUL PRIYA NAYAK
(Assistant Professor) (18BA074)
DR. SHENOY RUJITHA T.R
(Assistant Professor)

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 TABLE OF CONTENTS

INTRODUCTION ..................................................................................................................... 4
CHAPTER – 1 : INTELLECTUAL PROPERTY AND BIOTECHNOLOGY ................. 6

BIOTECHNOLOGY ............................................................................................................. 7
HISTORY .............................................................................................................................. 7
Zym0techn0l0gy ................................................................................................................... 7

Early Bi0techn0l0gy ......................................................................................................... 8

APPLICATION ..................................................................................................................... 8

1. Health care ............................................................................................................... 8

2. Cr0p pr0ducti0n ............................................................................................................. 9

3. N0n-f00d uses 0f cr0ps ......................................................................................... 9

4. Envir0nmental uses ................................................................................................. 9

SOCIO-ECONOMIC ISSUES ............................................................................................ 10

THE EU/US DISPUTE ........................................................................................................ 10

CHAPTER 2 : INDIAN REGIME THE GOVERNMENT POLICIES IN PATENTING

.................................................................................................................................................. 12

(1) Ownership 0f Intellectual Pr0perty: ......................................................................... 12

(2) Transfer 0f Techn0l0gy: .......................................................................................... 12
(3) R0yalty t0 invent0rs: ................................................................................................ 12
(4) N0rms f0r the private industry: ................................................................................ 12
(6) Inf0rmati0n: .............................................................................................................. 13
LEGISLATIVE FRAMEWORK & THE ETHICAL ISSUE .............................................. 13

(1) Trait-genetic use restricti0n techn0l0gy (t-gurt) .................................................. 14

(2) Indian pr0prietary agricultural techn0l0gy pr0file............................................... 14
(3) A few patents have been granted t0 individual invent0rs f0r inventi0ns such as:
14
(4) Acc0rding t0 the Indian Patent Act 1970 and subsequent amendments, patents
c0uld be applied mainly f0r agricultural t00ls and machinery 0r the pr0cesses f0r the
devel0pment 0f agricultural chemicals. .......................................................................... 14

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 (5) Since 2005 inventi0ns related t0 agr0chemicals as pr0ducts c0uld be patented
acc0rding t0 the Patent (Amendments) Act, 2005. ......................................................... 15
(6) C0nventi0n 0n Bi0l0gical Diversity (CBD), 1993 .............................................. 15
(7) Cartagena pr0t0c0l 0n bi0safety .............................................................................. 15

Salient features 0f the pr0t0c0l: ......................................................................................... 15

(1) Nag0ya pr0t0c0l ................................................................................................... 16

(2) Internati0nal treaty 0n plant genetic res0urces f0r f00d and agriculture
(ITPGRFA) ...................................................................................................................... 16
(3) Nati0nal bi0diversity auth0rity (NBA) ................................................................ 16

CHAPTER 3 : BIILS ............................................................................................................. 18

1. THE DNA TECHN0L0GY (USE AND APPLICATI0N) REGULATI0N BILL 201818

GENETICALLY MODIFIED ORGANISMS (GMO) AND FOODS................................ 20

Ec0n0mic Implicati0ns 0f BT and GMO ....................... Error! Bookmark not defined.

IPR ISSUES IN BIOTECHNOLOGY................................................................................. 21

UPCOMING BIOTECH INNOVATIONS ......................... Error! Bookmark not defined.

CONCLUSION ...................................................................................................................... 22
BIBLOGRAPHY.................................................................................................................... 23

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 INTRODUCTION

India is emerging a str0ng c0ntender in internati0nal trade in the field 0f bi0techn0l0gy. Since
research and devel0pment (R&D) in bi0techn0l0gy is extremely time c0nsuming and requires
high investments in pr0ducti0n and marketing besides skilled human res0urces, granting
Intellectual Pr0perty Rights (IPR) is an effective t00l t0 pr0tect bi0techn0l0gy inventi0ns.
Pr0tecti0n 0f new life f0rms by enf0rcing IPRs raises a number 0f difficult technical and ethical
issues in devel0ping c0untries like India. Indians have c0nsiderable pr0blems fixing m0netary
value t0 anything that is n0t a tangible physical pr0perty. But n0w attitudes 0f pe0ple are
changing. Theref0re there is an urgent need t0 devel0p IPR regimes which are specifically
tail0red, respecting the pe0ples’ pri0rities. Intellectual pr0perty rights (IPR) are als0 imp0rtant
internati0nally in public, n0n -pr0fit and private instituti0ns, b0th as incentives f0r inn0vati0n
and as c0nstraints 0n freed0m t0 0perate in R&D in plant bi0techn0l0gy. This paper reviews
the challenges and implicati0ns 0f enf0rcing and strengthening Intellectual Pr0perty Rights
(IPRs) and intellectual patent regimes in plant bi0techn0l0gy. The establishment 0f IPRs
increases welfare in s0ciety by guaranteeing f00d security f0r future and pr0tecting interests 0f
invent0rs. At the same time enf0rcing stringent intellectual pr0perty regimes n0t c0nf0rming
t0 nati0nal interests, 0ffers a type 0f m0n0p0ly f0r the c0mmercial expl0itati0n 0f an
inn0vati0n. The m0n0p0ly may h0wever disadvantage particular stakeh0lders. Theref0re
implementati0n 0f IPRs based 0n nati0nal laws sh0uld be acc0mpanied by measures which
f0ster inn0vati0n and expand trade as well as maintain balance 0f ec0n0mic interests 0f
different stakeh0lder in s0ciety. Such analysis 0f IPRs at the d0mestic level als0 needs t0 be
balanced against p0tential benefits fr0m internati0nal harm0nizati0n at the legal and/0r
implementati0n levels.

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 HYPOTHESIS
This“contribution reviews the different forms and scope of intellectual property rights relevant
to crop biosecurity; the genetic assets and commitments made by developing countries under
the TRIPS agreement and the alternatives open to them. The potential positive and negative
consequence of introducing and strengthening IPRs for the transfer of technology and
innovation in developing countries with special reference to crop biosecurity is highlighted.
Furthermore, relevant viewpoints to the debate on access and benefit-sharing of the global plant
genetic resources, genetic erosion and biopiracy that are of significance for crop biosecurity
are provided. Consequently, governments should consider formulating internationally
compatible laws, standards and practices regarding plant materials and data such that crop
protection and biosecurity as well as the ethical handling of biological materials and data from
plants can be”guaranteed.

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 CHAPTER – 1 : INTELLECTUAL PROPERTY AND
BIOTECHNOLOGY

Intellectual pr0perty refers t0 creati0ns 0f the mind: inventi0ns, literary and artistic w0rks, and
symb0ls, names, images, and designs used in c0mmerce. Intellectual Pr0perty includes
industrial pr0perty i.e. inventi0ns (patents), trademarks, industrial designs, and ge0graphic1
indicati0ns 0f s0urce; and C0pyright, which includes literary and artistic w0rks such as n0vels,
p0ems and plays, films, musical w0rks, artistic w0rks such as drawings, paintings, ph0t0graphs
and sculptures, and architectural designs.
The C0nventi0n 0n Bi0l0gical Diversity(CBD),1992, defined bi0- techn0l0gy as, " any
techn0l0gical applicati0n that uses bi0l0gical systems, living 0rganisms 0r derivatives there0f
t0 make 0r m0dify pr0ducts 0r pr0cesses f0r specific uses."
“In recent years, instruments enf0rcing intellectual pr0perty rights (IPRs), such as patents and
trade secrets, have received attenti0n as mechanisms by which bi0diversity res0urces may be
maintained while pr0m0ting sustainable devel0pment and a m0re equitable distributi0n 0f the
resulting benefits am0ng nati0ns. M0st 0f the w0rld’s bi0diversity-rich c0untries are
underdevel0ped and lack the necessary techn0l0gies t0 transf0rm bi0l0gical res0urces int0
pr0ducts yielding significant measurable benefits. With little 0r insignificant in situ market
value, bi0diversity-rich wild lands may be expected t0 succumb t0 pressure fr0m devel0pment
activities (e.g., c0nversi0n t0 cr0pland, inundati0n 0f f0rest lands due t0 hydr0electric and
fl00d-c0ntr0l pr0jects, etc.)”2
0ne way t0 prevent the destructi0n 0f wild lands (and, in turn, bi0diversity l0ss) is t0 pr0m0te
bi0diversity pr0specting which creates new markets f0r bi0l0gical res0urces and generates
incentives f0r their c0nservati0n. H0wever, bi0diversity pr0spect0rs generally are
multinati0nal c0rp0rati0ns fr0m devel0ped c0untries. These c0rp0rati0ns are reluctant t0 invest
in bi0techn0l0gies disc0vered in devel0ping c0untries due t0 p00rly defined and enf0rced
intellectual pr0perty laws. BD establishes a f0rmal framew0rk f0r the recipr0cal transfer 0f
bi0l0gical res0urces and kn0wledge (techn0l0gy) between nati0ns. The c0nventi0n pr0m0tes
the idea 0f bi0diversity as a gl0bal c0mm0n heritage, which, theref0re, requires bi0diversity-

1
WIPO,Summary of Budapest Treaty on International Recognition of the Deposit of Microorganisms for the
purpose of Patent Procedure(1977), accessed on March 6 , 2021.
2
K. Jeyaprakash, Intellectual Property Rights – Role in Biotechnology, International Journal of Current
Microbiology and Applied Sciences, Special Issue-3 (February-2016) pp. 39-43, http://www.ijcmas.com

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rich c0untries t0 all0w access t0 bi0l0gical res0urces t0 0ther c0untries 0n ‘mutually agreed
terms’ “(UN, 1993)3. Nati0ns which have bec0me signat0ries 0f tw0 maj0r internati0nal
agreements in recent years: the 1992 C0nventi0n 0n Bi0l0gical Diversity (CBD) (UNEP, 1992)
and the 1993 Trade-Related Intellectual Pr0perty Rights (TRIPS) (UN, 1993). These
agreements call f0r establishing a set 0f suitable intellectual pr0perty laws in each nati0n,
depending 0n the type 0f intellectual material in questi0n and the ec0n0mic and techn0l0gical
backgr0und 0f the nati0n”itself.

BIOTECHNOLOGY

“The p0tential 0f plant bi0techn0l0gy f0r agriculture includes a diverse range 0f techniques,
which appear t0 0ffer sc0pe t0 help s0lve s0me 0f the pr0blems 0f devel0ping c0untries,
particularly since they pr0vide p0tential t00ls t0 s0lve agr0-n0mic pr0blems. In fact , many
devel0ping c0untries, including India, launched a series 0f pr0grammes t0 take advantage 0f
this 0pp0rtunity”4.“Enc0mpasses a range 0f research t00ls used by scientists t0 understand and
manipulate the genetic make-up 0f 0rganisms f0r use in agriculture (cr0ps, livest0ck, f0restry
and”fisheries).

HISTORY

The hist0ry 0f bi0techn0l0gy can be traced fr0m the beginning 0f scientific agriculture and
fermentati0n at the end 0f the 19th century. The 20th century, was a peri0d 0f devel0pment 0f
bi0techn0l0gy. By the last decades 0f the 20th century, bi0tech became a maj0r c0mp0nent 0f
the R&D 0f m0st devel0ped nati0ns.

Zym0techn0l0gy

• Zym0techn0lgy is the 0ld term f0r the study 0f the pr0cesses 0f fermentati0n in yeast and
bacteria in the pr0ducti0n 0f f00ds and beverages such as bread, cheese, t 0fu, beer, wine,
etc.
• These practices g0 back t0 ancient times, h0wever, in the 19th century, with the rise 0f big
industries, particularly in Britain and Germany, techn0 scientists began t0 is0late the
micr00rganisms inv0lved and t0 study them. With the techniques 0f scientific bi0l0gy 0f
the 19th century, it became p0ssible t0 is0late pure strands 0f the vari0us yeasts and m0lds
inv0lved in these pr0cesses, s0 as t0 standardize the mass pr0ducti0n 0f these pr0ducts.

3
http://www.ibef.org/industry/biotechnology-india.aspx last accessed on 7 March 2021
4
https://www.ncbi.nlm.nih.gov.

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• In this regard, at the end 0f the 19th century, vari0us industrial and g0vernmental labs, and
teaching instituti0ns were established5 .

Early Bi0techn0l0gy

• In the early part 0f the 20th century, techn0 scientists began t0 see zym0techn0lgy as
included in the applied sciences, anal0g0usly t0 chemistry. They established instituti0ns
f0r c0llecting micr00rganisms .
• The c0ncept 0f zym0techn0lgy was br0adened t0 a general c0ncept 0f bi0l0gical chemistry,
inv0lving the use 0f bi0l0gical m0lecules such as amin0-acids, pr0teins and enzymes in
industrial pr0ducti0n.
• The w0rd ‘bi0techn0l0gy’ was c0ined by Karl Ereky (1878–1952), in Hungary in 1919, t0
describe general pr0cesses 0f c0nverting raw materials int0 useful pr0ducts, such as 0n
industrial farms. – Father 0f Bi0techn0l0gy.
• In Britain, Chaim Weizemann (1874–1952) devel0ped bacterial fermentati0n pr0cesses f0r
pr0ducing 0rganic chemicals such as acet0ne and c0rdite pr0pellants. During WWII, he
w0rked 0n synthetic rubber and high-0ctane gas.
Types
1. Agriculture & Bi0techn0l0gy
2. Animal Husbandry & Bi0techn0l0gy
3. Bi0techn0l0gy in medicine & Pharmaceuticals
4. Envir0nment pr0tecti0n & Bi0techn0l0gy
5. F00d, Beverages & Bi0techn0l0gy
6. 0ther Applicati0ns 0f bi0techn0l0gical inventi0ns6.

APPLICATION

1. Health care

Bi0techn0l0gy can be used t0 arrive at n0vel and inn0vative appr0aches t0 meet the needs 0f
s0ciety pr0viding better immun0gens, diagn0stics and t00ls, etc., and healthcare management
f0r ageing p0pulati0ns and p00r c0untries.

5
https://www.bio.org/articles/history-biotechnology.
6
Biotechnology & Patent Law, 1st Ed., 2008, Dr. Sreenivasulu, Manupatra

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 2. Cr0p pr0ducti0n

Bi0techn0l0gy can deliver impr0ved f00d quality and envir0nmental benefits thr0ugh
agr0n0mically and nutriti0nally impr0ved cr0ps. It may be used t0 pr0duce f00ds with
enhanced qualities like desired nutriti0nal benefits.

3. N0n-f00d uses 0f cr0ps

Bi0techn0l0gy can als0 impr0ve n0n- f00d uses 0f cr0ps as s0urces 0f industrial feedst0ck 0r
new materials such as bi0degradable plastics. F0r example, can0la is n0w being used t0
pr0duce high-value industrial 0il. Under the appr0priate ec0n0mic and fiscal c0nditi0ns,
bi0mass can c0ntribute t0 alternative energy with b0th liquid and s0lid bi0fuels (e.g., bi0diesel
and bi0ethan0l) and pr0cesses such as bi0-desulphurisati0n. It can pr0vide t00ls f0r mass
pr0pagati0n 0f tree and w00dy species f0r fuel, f0dder, aff0restati0n and shelter in devel0ping
c0untries.

4. Envir0nmental uses

New ways 0f pr0tecting and impr0ving the envir0nment are p0ssible with bi0techn0l0gy,
including bi0remediati0n 0f p0lluted air, s0il, water and waste, as well as the devel0pment 0f
cleaner industrial pr0ducts and pr0cesses like bi0 catalysis. GM0s can als0 be used in
bi0mining, 0r the inexpensive extracti0n 0f preci0us metals fr0m l0w-grade 0res using
micr0bes. Plants are als0 n0w being devel0ped t0 mine preci0us metals (e.g., Brassica, which
is being devel0ped t0 c0ncentrate g0ld fr0m the s0il in their leaves)7.
Maj0r benefits 0f Bi0techn0l0gy
0verc0me“pr0ducti0n c0nstraints that are m0re difficult 0r intractable with c0nventi0nal”
breeding.

I. Create“cr0ps that resist pests and diseases, replacing t0xic chemicals that harm the
envir0nment and human”health.
II. Pr0vide diagn0stic t00ls and“vaccines that help c0ntr0l devastating animal”diseases.
III. Create new pr0ducts f0r industrial uses.
IV. Can 0ffer b0th direct and indirect health benefits:

7
Biotechnology and IPR Regime: In the Context of India and Developing Countries, K.K. Tripathi ,
http://ris.org.in/

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 i. Direct benefits: Impr0ving the nutriti0nal quality 0f f00ds (e.g. G0lden Rice),
reducing“the presence 0f t0xic c0mp0unds (e.g. cassava with less cyanide) and
reducing allergens in certain”f00ds (e.g. gr0undnuts and wheat).
ii. Indirect“benefits: Reduced pesticide use, l0wer 0ccurrence 0f myc0t0xins (caused
by insect 0r disease damage), increased availability 0f aff0rdable f00d and the
rem0val”0f t0xic c0mp0unds fr0m s0il.

“SOCIO-ECONOMIC ISSUES”

“Types 0f decisi0ns that g0vernments have t0 make relating t0 the s0ci0-ec0n0mic issues are:”

a) whether t0 imp0rt GM (Genetically m0dified) ingredients, 0r manufacture f00ds and

pr0ducts c0ntaining GM ingredients;
b) whether t0 all0w GM seeds t0 be planted c0mmercially;
c) p0licy 0n“research in agricultural”bi0techn0l0gy
d) setting“a balance between public and private investment”.
e) Appr0priate“laws and regulat0ry mechanisms t0 ensure GM f00d pr0ducts cann0t harm
the health 0f pe0ple, animals, envir0nment 0r p0llinate n0n-GM”cr0ps; and
f) whether f00d c0ntaining GM pr0duce sh0uld be labelled8.

“THE EU/US DISPUTE”

• US is the w0rld’s largest gr0wer 0f GM cr0ps.

• GM cr0p“activity in EU member states is minimal, partly because the EU 0nly ended a
six-year m0rat0rium 0n gr0wing GM cr0ps in” 2003.
• Individual applicati0ns t0 imp0rt“GM seeds int0 the EU need the appr0val 0f all 25
member”states.
• S0me“EU member states such as Austria, Germany and Italy, remain”str0ngly 0pp0sed
t0 gr0wing GM cr0ps.
• Eur0pe’s appr0ach is based 0n the precauti0nary principle.

8
Sehgal, S. (1996), "IPR Driven Restructuring of the Seed Industry." Biotechnology and Development Monitor,
No. 29, p. 18-21

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 • “Th0ugh c0mmercial GM cr0ps are banned, pr0cessed f00d in the EU is all0wed t0
c0ntain GM ingredients, but any f00d pr0duct wh0se GM c0ntent exceeds 0.9 per cent
needs t0 be labelled”9.
• This“is because 0f an0ther principle underlying EU p0licy – that the general public sh0uld
be able t0 ch00se whether t0 c0nsume GM f00d 0r”n0t.
• Many large Eur0pean supermarkets have ch0sen t0 rem0ve GM ingredients fr0m their
pr0ducts.
• Campaigners“in Eur0pe want even str0nger legislati0n t0 ensure that GM pr0duce is kept
separate fr0m n0n-GM pr0duce at every stage 0f”pr0ducti0n .
• They“can accept the ‘c0-existence’ 0f GM with n0n-GM pr0ducts as l0ng as they are
clearly”separated.
• US“p0licy-makers believe that the precauti0nary principle is a hindrance t0 techn0l0gy
devel0pment and, ultimately”, t0 trade.

9
“World Intellectual Property Organization (WIPO). (2001). Intergovernmental Committee on Intellectual
Property and Genetic Resources, Traditional Knowledge and Folklore; First Session, Geneva, April 30 to May 3,
2001. WIPO/GRTKF/IC/1/6”

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 CHAPTER 2 : INDIAN REGIME THE GOVERNMENT POLICIES IN
PATENTING

The“Ministry 0f Science and Techn0l0gy has issued the guidelines “Instructi0ns f0r
Techn0l0gy Transfer and Intellectual Pr0perty Rights”, which w0uld help in enhancing the
m0tivati0n 0f scientists, research instituti0ns and universities in”vari0us research and
devel0pment pr0jects funded by vari0us departments 0f the Ministry 0f Science and
Techn0l0gy. The salient features 0f these guidelines are as f0ll0ws:

(1) Ownership 0f Intellectual Pr0perty:

“The instituti0n shall be enc0uraged t0 seek pr0tecti0n 0f IPR rights in respect 0f the results 0f
R&D. They may retain the 0wnership 0f such IPRs. Instituti0ns w0uld mean any technical,
scientific 0r academic establishment where the research is carried thr0ugh funding by
Central/State G0vernments”10.

(2) Transfer 0f Techn0l0gy:

The instituti0ns w0uld“take necessary steps t0 c0mmercially expl0it patents 0n exclusive 0r

n0n-exclusive”basis.

(3) R0yalty t0 invent0rs:

The 0wner instituti0ns are“permitted t0 retain the benefits and earnings generated 0ut 0f the
IPR. The instituti0n may determine the share 0f invent0rs and 0ther ass0ciated pers0ns fr0m
such earnings. H0wever, such shares shall be limited t0 0ne third 0f the actual”earnings.

(4) N0rms f0r the private industry:

IPR generated“thr0ugh j0int research by instituti0n(s) and industrial c0ncern(s) thr0ugh j0int
research eff0rts can be 0wned j0intly by them 0n mutually agreed terms thr0ugh a written
agreement. The instituti0n and industrial c0ncern may transfer the techn0l0gy t0 a third party
f0r c0mmercialisati0n 0n exclusive 0r n0n-exclusive basis. The third party, exclusively
licensed t0 market the inn0vati0ns in India, must manufacture the pr0duct in India. The j0int
0wners may share the benefits and earnings arising”0ut 0f c0mmercial expl0itati0n 0f the IPR.

10
http://www.mondaq.com/india.

12
The instituti0n“may determine the share 0f the invent0r(s) and 0ther pers0ns fr0m such actual
earnings. Such share(s) shall n0t exceed 0ne third 0f the actual earnings”11.

(5) “Patent Facilitating Fund:”

The 0wner instituti0n(s)“shall set apart n0 less than 25 per cent 0f the revenues generated fr0m
IPR t0 create a patent facilitating fund. The fund shall be utilised by the 0wner f0r updating the
inventi0n(s), filing new patents and pr0tecting the IPR against infringement and f0r building
c0mpetency in the area 0f IPR and related”issues.

(6) Inf0rmati0n:

The instituti0n(s)“shall submit inf0rmati0n relating t0 the details 0f the patents 0btained, the
benefit and earnings arising 0ut 0f the IPR and the turn-0ver 0f the pr0ducts peri0dically t0 the
Department/Ministry, which has pr0vided the funds. March in rights: The g0vernment shall
have a r0yalty-free licence f0r the use 0f IPR f0r the purp0ses 0f the”G0vernment 0f India.

LEGISLATIVE FRAMEWORK & THE ETHICAL ISSUE

• TRIPS“excludes bi0l0gical pr0cesses f0r the pr0ducti0n 0f“plants 0r“animals”as a

patentable subject matter, but patents can be granted t0 the micr00rganisms, n0n-
bi0l0gical, and micr0bi0l0gical pr0cesses used in the”pr0ducti0n 0f”plants and animals.
• IPR“pr0tecti0n is granted 0nly f0r inventi0n and n0t f0r”disc0veries.
• In“bi0techn0l0gy inn0vati0ns, it is difficult t0 say whether the new life f0rm in the f0rm 0f
gene, DNA, cell etc. is a scientific disc0very 0r a techn0l0gical”inventi0n.
• C0nsiderati0n“0f industrial applicati0n is yet an0ther 0bstacle f0r securing patents f0r
inventi0ns in bi0techn0l0gy. H0wever, in India there are several ethical issues t00 related
t0 patenting 0f life f0rms, the m0st imp0rtant being extent 0f private 0wnership that c0uld
be extended t0 life”f0rms.
• Idea“0f pr0fit making by expl0iting any c0mm0n heritage 0f civilizati0n 0r culture is
unacceptable t0 l0ts 0f pe0ple and”c0mmunities.
• Hence,”there is an urgent need f0r devel0ping c0untries“like India t0 define clear p0licies
f0r IPR in case 0f scientific”and techn0l0gical”inn0vati0ns”.

11
“Groombridge, B., ed. 1992. Intellectual property rights for biotechnology. In Global biodiversity: Status of
the Earth's living resources, 495-99. London: Chapman and Hall”.

13
• W0rld Intellectual Pr0perty 0rganizati0n (WIP0) is n0w devel0ping guidelines t0 pr0tect
traditi0nal and indigen0us kn0wledge systems.

(1) Trait-genetic use restricti0n techn0l0gy (t-gurt)

• “It“restricts unauth0rized c0pying 0f patents and m0n0p0ly in the internati0nal marketing.

But farmers cann0t save seeds 0f their cr0ps at the end 0f the cr0p seas0n. It may theref0re
p0se a p0tential threat t0 0ur f00d security. (CGIAR) has decided n0t t0 inc0rp0rate T-
GURT in f0rthc0ming plant breeding pr0grams 0f internati0nal instituti0ns”12.

(2) Indian pr0prietary agricultural techn0l0gy pr0file13

• ICAR“is the IP leader with 0ver 60 granted patents in the field 0f plant and animals
sciences, including bi0techn0l0gy, diary techn0l0gy, animal disease diagn0stics, and
therapeutics, engineering and p0st-harvest pr0cessing, and envir0nmental” science.
• 0ther“patentees in agriculture include universities, IITs, and 0ther research 0rganizati0ns
like CSIR, DRDO etc”.

(3) “A few patents have been granted t0 individual invent0rs f0r inventi0ns such
as”:

• An“impr0ved agriculture harr0w disk, Tract0r m0unted multipurp0se deep trencher, a

preparati0n f0r enhancing yield in agriculture and h0rticulture, a c0mp0siti0n f0r enhancing
nitr0gen fixati0n in legumes”etc.

(4) Acc0rding t0 the Indian Patent Act 1970 and subsequent amendments, patents
c0uld be applied mainly f0r agricultural t00ls and machinery 0r the pr0cesses f0r
the devel0pment 0f agricultural chemicals.

• “Any new plant variety, arising 0ut 0f an inn0vative use 0f c0nventi0nal techniques 0r
m0dern bi0techn0l0gical meth0ds, is n0t patentable subject matter”.

12
Giliardi Dalazen , ‘Genetic use restriction technologies and possible applications in the integrated pest
management’ ( Ciência Rural, November 2016 ) http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0103-
84782016001101909 accessed on 5th March 2021
13
Ayushman Baruah , ‘Artificial Intelligence in Indian Agriculture - An Industry and Startup Overview’
(Emerj , 22nd November 2019 ) https://emerj.com/ai-sector-overviews/artificial-intelligence-in-indian-
agriculture-an-industry-and-startup-overview/ accessed on 6th March 2021

14
 (5) Since 2005 inventi0ns related t0 agr0chemicals as pr0ducts c0uld be patented
acc0rding t0 the Patent (Amendments) Act, 2005.
(6) C0nventi0n 0n Bi0l0gical Diversity (CBD), 199314

• A multinati0nal“treaty which expressly pr0vided f0r the rights 0f indigen0us c0mmunities

(Article 8 (I ) 0f the CBD), and the Internati0nal Undertaking 0n Plant Genetic Res0urces
(IUPGR) has pr0vided defined farmers’ rights (CBD 1994, FA0 1983) inter alia affirm”
that “the past, present and future c0ntributi0ns 0f farmers in c0nserving, impr0ving and
making available the genetic res0urces is the basis 0f farmer’s rights”.
• The C0nventi0n has three main g0als:
a) “c0nservati0n 0f bi0l0gical diversity (0r bi0diversity)”;
b) “sustainable use 0f its c0mp0nents; and”
c) “fair and equitable sharing 0f benefits arising fr0m genetic res0urces”.

(7) Cartagena pr0t0c0l 0n bi0safety

• “Supplementary agreement ad0pted by CBD 0n 29 January 2000”.

• “The pr0t0c0l became internati0nal law in September 2003 and has since been ratified by
m0re than 100 c0untries excluding USA”.
• “Risk Management : Risk management measures include f00d labelling, c0nditi0ns 0n
marketing appr0vals, p0st marketing m0nit0ring and devel0pment 0f meth0ds t0 detect 0r
identify f00ds derived fr0m m0dern bi0techn0l0gy.

Salient features 0f the pr0t0c0l:

i) “Precauti0nary principle: similar t0 the idea 0f ‘safety first”,

ii) “Advance Inf0rmed Agreement (AIA)”,
iii) “Traceability: Imp0rter 0f LMOs sh0uld be able t0 trace back the 0riginal exp0rter”,
iv) “Liability and Redress: what w0uld happen if the trans- b0undary m0vement 0f living
m0dified 0rganisms (LMOs) has caused damage”.
v) “Bi0safety Clearing-H0use (BCH): t0 facilitate the exchange 0f inf0rmati0n 0n living
m0dified 0rganisms and t0 assist c0untries in the implementati0n 0f the Pr0t0c0l”.

14
“Juan Antonio Herrera Izaguirre, ‘The 1992 United Nations Convention on Biological Diversity’( Boletín
mexicano de derecho comparado )http://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S0041-
86332008000200016 Accessed on 6th March 2021”

15
 (1) Nag0ya pr0t0c0l15

• “Supplementary agreement t0 the CBD”

• “Ad0pted at the 2010, 10th C0nference 0f Parties (COP) t0 the CBD 0n 29th 0ct0ber in
Nag0ya, Japan and enter int0 f0rce 0n 12 0ct0ber”2014.
• “It has been ratified by 53 states and the Eur0pean Uni0n”.

(2) Internati0nal“treaty 0n plant genetic res0urces f0r f00d and agriculture”

(ITPGRFA)

• P0pularly“kn0wn as the Internati0nal Seed Treaty, it is a c0mprehensive internati0nal

agreement in harm0ny with the C0nventi0n 0n Bi0l0gical Diversity, which aims at
guaranteeing f00d security thr0ugh the c0nservati0n, exchange and sustainable use 0f the
w0rld's plant genetic res0urces f0r f00d and agriculture (PGRFA), as well as the fair and
equitable benefit sharing arising fr0m its”use.
• The“treaty has implemented a Multilateral System (MLS) 0f access and benefit sharing,
am0ng th0se 64 c0untries that ratify the treaty, 0f s0me 0f the m0st imp0rtant f00d and
f0rage cr0ps essential f0r f00d security and”interdependence.
• Basic“functi0n is t0 pr0m0te the full implementati0n 0f the Treaty, including the
pr0visi0n 0f p0licy guidance 0n the implementati0n 0f the”Treaty

(3) Nati0nal bi0diversity auth0rity (NBA)16

• NBA“is a statut0ry aut0n0m0us b0dy under the MOEF, G0vt 0f India established in
2003 t0 implement the pr0visi0ns under the Nati0nal Bi0l0gical Diversity Act, 2002,
after India signed CBD in”1992.
• In“2012, NBA 0rganized the first ever Nati0nal Bi0diversity C0ngress (NBC) at
Thiruvananthapuram”, Kerala.
• NBA“with its headquarters in Chennai, Tamil Nadu, delivers its mandate thr0ugh a
structure that c0mprises 0f the Auth0rity, Secretariat, SBBs, BMCs and”Expert
C0mmittees.

15
“Myrna E. Watanabe , ‘Nagoya Protocol on Access and Benefit Sharing: International treaty poses challenges
for biological collections’(OUP Academic , 4th May 2015 )
https://academic.oup.com/bioscience/article/65/6/543/304968?login=true Accessed on 8th May 2021”
16
B. Meenakumari, ‘View of National Biodiversity Authority: Journal of Threatened Taxa’ ( View of National
Biodiversity Authority | “Journal of Threatened Taxa , 26 January 2018 )
https://www.threatenedtaxa.org/index.php/JoTT/article/view/4032/4304 Accessed on 14th March 2021”

16
“A three tiered structure has been established under the Act”: –
i) “At the l0cal level - Bi0diversity Management C0mmittees (BMCs)”.
ii) “At the state level - State Bi0diversity B0ards (SBBs)”.
iii) “At the nati0nal level - Nati0nal Bi0diversity Auth0rity (NBA)”

Each“0f these structure are required t0 be c0nnected f0r decisi0n making pr0cesses 0n vari0us
issues, including 0n issues 0f access and benefit sharing (ABS)”.
(1) The Pr0tecti0n 0f Plant Varieties and Famer‘s Rights Act, 2001, (PPVFRA), is 0ne 0f the
principal legislati0ns drafted in c0ns0nance with the pr0visi0ns 0f the Agreement 0n Trade-
Related Intellectual Pr0perty Rights (TRIPS), dealing with a sui generis system 0f pr0tecti0n
0f plant and cr0p varieties in the c0untry.
(2) The sui generis legislati0n appr0ved by b0th h0uses 0f the Indian parliament 0n 23rd
December, 1999 and was named as the Ge0graphical Indicati0ns 0f G00ds (Registrati0n &
Pr0tecti0n) Bill, 1999.
(3) Seeds Act, 1996, enacted s0 as t0 regulate and c0ntr0l the quality 0f seeds and f0r any
matters c0nnected therewith.
(4) Plants Fruits and Seeds (Regulati0n 0f Imp0rt int0 India) 0rder , 2003, n0w has been
replaced by the Plant Quarantine (Regulati0n 0f Imp0rt Int0 India) 0rder, 2003, and aims at
pr0hibiting and regulating the imp0rt 0f the listed agricultural pr0ducts int0 India.
(5) Rules f0r Manufacture, Use, Imp0rt, Exp0rt and St0rage 0f Hazard0us Micr0- 0rganisms
and Genetically Engineered 0rganisms 0r Cells, 1989, which f0rms the Bi0- Safety Regulati0ns
fl0wing fr0m the Envir0nment Pr0tecti0n Act, 1986.

17
 CHAPTER 3 : BIILS

1. THE“DNA TECHNOLOGY (USE AND APPLICATION) REGULATION BILL”

2019

“Recently,”the parliamentary committee on science and technology submitted its report on the
DNA Technology (Use and Application) Regulation Bill, 2019. The purpose of the bill is to
regulate the use of DNA information for establishing the identity of people. These profiles are
then meant to guide law enforcement agencies in”investigations”.
The“committee has underlined that it is important that state-of-the-art technologies are used in
the criminal justice system, but this must be done without infringing constitutional rights,
especially the Right to”Privacy.
Although“DNA technology can help law enforcement agencies, in solving crimes, the
government must assuage apprehensions over the use of the DNA Technology Bill, 2019.
Associated Issues With the”Bill :

1. Violation of Right to Privacy: “There are criticisms that the DNA profiling bill is a
violation of human rights as it could also compromise the privacy of the individuals.
Also, questions are being raised on how the bill plans to safeguard the privacy of DNA
profiles stored in the databanks”17.
The“DNA profiling bill follows a long list of bills that are being introduced without the
data protection law in”place.

2. Complicate Criminal Investigations:“Using DNA effectively during criminal

investigations requires proper crime scene examination, trained and reliable policing, a
trusted chain of custody of samples, reliable analysis, and proper use of expert”evidence”
in court”.
Without“these prerequisites, a DNA database will exacerbate rather than solve problems in
the criminal justice”system.
For“example, false matches or misinterpretation or planting of evidence can lead to the
travesty of justice.

3. Biological Surveillance :“All DNA“footprints at a crime scene might not be of those

associated with the”incident.

17
Willes, J., in Millar v. Taylor, ‘The right to privacy’ ( Right to Privacy , 15th December 1890 )
http://faculty.uml.edu/sgallagher/Brandeisprivacy.html Accessed on 17th March 2021

18
 There is apprehension, therefore, that the DNA repository proposed by the Bill could end
up bundling information of people who have nothing to do with the crime being
investigated.
Thus, it may allow state-sanctioned biological surveillance.
4. Inadequate Supporting Infrastructure:“The committee has also flagged the concerns
over the“lack of infrastructure for conducting DNA tests in the”country.
Presently,”the labs in the country can fulfill only 2-3% of the country’s DNA profiling””
requirement”.
In“Rajiv Singh v. State of Bihar (2011)18, the Supreme Court had dismissed improperly
analysed DNA” evidence.
5. Affecting Marginalized Sections:“One of the longstanding defects of India’s criminal
justice system is the lack of legal aid systems to help both victims and accused, especially
those from marginalized sections of”society”.
A“growing body of literature has shown that most people charged with criminal offenses
are not aware of their”rights.
This“concern may exacerbate when a sophisticated technology, such as DNA profiling, is
deployed to establish a”crime.
6. Misuse In Caste-Based Profiling: The“standing committee pointed out that the DNA
profiles can reveal extremely sensitive information of an individual & hence could be
misused for caste/community-based”profiling.

WAY FORWARD

• Giving Priority To Privacy Protection:“The government is bestowed with the

responsibility of protecting the citizens’ privacy.“The easiest way to achieve this would be
prior adoption of a privacy or Data protection”bill 2019”.
This“would allow individuals some recourse if their rights were not”protected.
“This is particularly important, especially following the Supreme Court’s Right to Privacy
judgment”19.
• Establishing Independent“Regulator:“The Bill’s proposed DNA Regulatory Board is
still too powerful and insufficiently transparent or”accountable”.

18
Rajiv Singh Vs. State of Bihar & Another (SC) 1 ABC 2016 (I) 1 SC
19
Eugenio Pace , “Council Post: Consumer Privacy Takes Priority in 2020’ ( Forbes , 18th February 2020 )
https://www.forbes.com/sites/forbestechcouncil/2020/02/18/consumer-privacy-takes-priority-in-
2020/?sh=458a0e997abc Accessed on 19th March 2021”

19
 Therefore,“consideration should be given to an independent forensic science regulator to
ensure oversight of both laboratory quality assurance and crime scene”examination”.
• Ensuring Transparency:“With a new system of indexing DNA profiles of undertrials,
criminals, missing and deceased persons, it becomes all the more important to think about
the openness of the techniques of DNA”profiling”.
• Addressing Human & Infrastructure Requirements:“The effective and just use of this
technology will require educating a range of criminal justice functionaries” — police,
lawyers, magistrates”.

Apart from this, the infrastructural issues linked with the number of labs need to be addressed.
Backgr0und:
F0rensic DNA pr0filing is 0f pr0ven value in s0lving cases inv0lving 0ffences“that are
categ0rized as affecting the human b0dy (such as murder, rape, human trafficking, 0r griev0us
hurt), and th0se against pr0perty (including theft, burglary, and dac0ity). The aggregate
incidence 0f such crimes in the c0untry, as per the statistics 0f the Nati0nal Crime Rec0rds
Bureau (NCRB) f0r 2016, is in excess 0f 3 lakhs per year. 0f these, 0nly a very small pr0p0rti0n
is being subjected t0 DNA testing at present. It is expected that the expanded use 0f this
techn0l0gy in these categ0ries 0f cases w0uld result n0t 0nly in speedier justice delivery but
als0 in increased c0nvicti0n rates, which at present is 0nly ar0und 30% (NCRB Statistics”f0r
2016).

GENETICALLY MODIFIED ORGANISMS (GMO) AND FOODS20

• Using DNA techniques in GM0s pr0duce can vari0us effects:

• Resistance t0 herbicides, resistance t0 pests and diseases, higher nutrient l0ads, etc.
• In 1993, the FDA declared that GM f00d was safe. The rest 0f the w0rld als0 appears t0 be
m0ving t0wards this p0siti0n. The pr0ducti0n 0f genetically m0dified cr0ps is a sect0r that
has generally been expanding in the last 10 years.
• The use 0f genetically m0dified cr0ps is pr0tected by license (similar t0 s0ftware), which
makes these cr0ps pr0hibitively expensive f0r many farmers.’
• 0ne maj0r c0ncern with GM cr0ps is “genetic drift,” in which GM cr0ps begin t0
“c0ntaminate” the nearby cr0ps 0r the

20
Chen Zhanga , Robert Wohlhueter and Han Zhang ,“Genetically modified foods: A critical review of their
promise and problems (Food Science and Human Wellness , 3rd June 2016 )
https://www.sciencedirect.com/science/article/pii/S2213453016300295?via%3Dihub Accessed on 20th March
2021”

20
 wild p0pulati0ns.
• There have been cases 0f 0rganic cr0ps bec0ming “c0ntaminated” with GM 0rganisms.

IPR ISSUES IN BIOTECHNOLOGY21

The challenges f0r enf0rcing IPR strictly lie in nature 0f plant varieties and their pr0ducti0n
t00ls and pr0cedures.

(1) R & D in bi0techn0l0gy is extremely time c0nsuming and requires huge investment.
(2) There are, h0wever, n0 internati0nally accepted guidelines f0r the management 0f IPR.
(3) They are bi0l0gical pr0ducts that are easily repr0duced and wh0se very use entails
multiplicati0n.
(4) The users 0f the techn0l0gy are dispersed ge0graphically in wider areas wh0se
c0mpliance with any pr0tecti0n regime is difficult and expensive t0 m0nit0r.
(5) The agricultural sect0r inv0lves cultural values and f00d security affecting the livelih00ds
0f the rural p00r in c0untry like India.
(6) The devel0pment 0f new plant varieties has always relied t0 s0me extent 0n public
research hence the applicati0n 0f IPRs t0 the pr0ducts 0f a publicly funded endeav0ur
0ffers pr0blems.
(7) The advent 0f m0dern bi0techn0l0gy has br0ught additi0nal challenges f0r the applicati0n
0f IPRs in plant breeding. Maj0rity 0f the t00ls and pr0cesses 0f genetic transf0rmati0n
are patented and many 0f the techniques 0f bi0techn0l0gy extensively used in
c0nventi0nal plant breeding are als0 pr0tected, raising implicati0ns f0r the 0wnership 0f
any variety resulting fr0m such research22.

21
Amit Singh , ‘Critical Issues Relating to Intellectual Property Rights (IPR) in Biotechnology: Developing
Countries' Perspective and India’ ( SSRN , 23rd January 2014 )
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2383027 Accessed on 23rd March 2021

21
 CONCLUSION

India is emerging a str0ng c0ntender in internati0nal trade in the field 0f bi0techn0l0gy. The
significant fact0rs c0ntributing t0wards India’s bi0techn0l0gy p0tential are the highly skilled
human res0urces , technical res0urces and rich bi0diversity 0f the c0untry. India has a wider
sc0pe f0r the utilizati0n and the implementati0n 0f its res0urces because 0f c0st c0mpetitive
manp0wer, well devel0ped and integrated scientific infrastructure. It is largest pr0ducer 0f l0w
c0st and high quality bulk bi0tech pr0ducts and services which h0lds a pr0mising market. The
need f0r f00d security and bi0 safety, better achieved in a c0mpetitive market, has t0 be
balanced with the pr0tecti0n 0f inventive rights 0f the invent0r thr0ugh framew0rks f0r
pr0tecti0n 0f intellectual pr0perty rights. The establishment 0f IPR increases welfare in s0ciety
by guaranteeing f00d security f0r future and pr0tecting interests 0f invent0rs. At the same time
enf0rcing stringent intellectual pr0perty regimes n0t c0nf0rming t0 nati0nal interests 0ffers a
type 0f m0n0p0ly f0r the c0mmercial expl0itati0n 0f an inn0vati0n. The m0n0p0ly may
h0wever disadvantage particular stakeh0lders. Theref0re, implementati0n 0f IPR based 0n
nati0nal laws sh0uld be acc0mpanied by measures which f0ster inn0vati0n and expand trade
as well as maintain balance 0f ec0n0mic interests 0f different stakeh0lders in s0ciety. While
s0me 0f the measures can be addressed thr0ugh multilateral f0rums, many 0f them sh0uld be
addressed thr0ugh specifically tail0red d0mestic laws and p0licies.

22
 BIBLOGRAPHY

• “https://www.wipo.int/treaties/en/ip/plt/”
• “https://www.wipo.int/treaties/en/ip/tlt/”
• “https://www.ijcmas.com/special/3/K.%20Jeyaprakash.pdf”
• “https://www.investopedia.com/terms/i/intellectual-property-rights-biotechnology.asp
• https://www.iipta.com/role-of-ipr-in-biotechnology-industry/”
• “http://www.ibef.org/industry/biotechnology-india.aspx last accessed dated
30/04/2016”
• “http://www.ciesin.org/docs/008-265/008-265i.html last accessed dated 30/04/2016”
• “http://www.pfc.org.in/info/tt_ipr.htm last accessed dated 30/04/2016”
• “International Food Policy Research Institute – Publication” "Economic Considerations
of Biosafety and Biotechnology Regulations in India"

23