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Intellectual Property Rights Issues inWTO regime
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Plan of Presentation
Indian Agriculture today IPR-what is it?
Various Forms Regulatory mechanisms at national level
Their relevance to agriculture IPR vis--vis Indian Agriculture Road map
Policy Researchers
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From independence India recognized and used science and
technology as major economy Green revolution based on scientific acumen
and technology Challenges to agricultural research still continue Advent of WTO compounded
Research has to come out of its sheltered existence to face an era of competitiveness
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Indian NARS
Public sector - ICAR, AUs, Universities,departments A strong element of private and voluntary
organizations Large commercial companies with their own
R&D capabilities Linkages/complementarily between components
becoming strong
6,428 scientific-ICAR; around 30,000 scientists in NARS
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Research in rice
Most widely researched crop Last five years GM technologies in rice-1990s 15 of 22 institutions in India on rice GM
technologies Same trait research groups ;
insect :8,fungal :6,viral :2,drought: 3,salinity:2
4 ICAR;5 Univ;2 Int centres;2 AUs;3 Nat inst;1NoG;1autonomous institute
Out of 10 on GM crops four on rice
Source:Indira et al,2005
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Transgenicbiotechnologies
Industrial application
Scientific research
Plant breeding
Traditional agriculture / associated T.K
Maintenance of natural biodiversity / associated T.K
The Pyramid of Knowledge
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Transgenicbiotechnologies
Industrial application
Scientific research
Plant breeding
Traditional agriculture / associated T.K
Maintenance of natural biodiversity / associated T.K
The Pyramid of Knowledge
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Transgenicbiotechnologies
Industrial application
Scientific research
Plant /Animal breeding
Traditional agriculture / associated T.K
Maintenance of natural biodiversity / associated T.K
The Pyramid of Knowledge
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Transgenicbiotechnologies
Industrial application
Scientific research
Plant Animal breeding
Traditional agriculture / associated T.K
Maintenance of natural biodiversity / associated T.K
The Pyramid of Knowledge
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Transgenicbiotechnologies
Industrial application
Scientific research
Plant /Animal breeding
Traditional agriculture / associated T.K
Maintenance of natural biodiversity / associated T.K
The Pyramid of Knowledge
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Transgenicbiotechnologies
Industrial application
Scientific research
Plant /Animal breeding
Traditional agriculture / associated T.K
Maintenance of natural biodiversity / associated T.K
The Pyramid of Knowledge
GR:fundamental resource;endless activity of breeding;vital to food security
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Agrigoods in Trade
Agrigoods in Trade WTO
WTO
Fear of Imbalanced Balances !
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The Major Regulatory Changes
The Convention on Biological Diversity 1992(CBD) Global Plan of Action 1996(GPA)
The International Treaty on Plant Genetic Resources for Food and Agriculture2001 (ITPGRFA)
Convention on International Trade in Endangered Species of Wild Fauna andFlora 1975(CITES)
World Trade Organization(WTO) Agreements such as Trade Related Aspectsin Intellectual Property Rights(TRIPS)and the SPS Agreement
Protection of Plant Varieties and Farmers Rights Act, 2001(PPV&FR Act)
The Biological Diversity Act, 2002(BD Act)
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Part II: Forms /Elements of IP
Copyright Trademark Patents Other IPs
Geographical IndicationsIndustrial DesignsIntegrated CircuitsTrade SecretsPlant Varieties
[Pertain to Part II : Standards of IPRs (Art. 9 to 40) (Sec. 1 to 8) of TRIPS includingcontrol of anti-competitive practices in contractual licenses]
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Has India amended its legislations as perTRIPS?
Yes
The Copyright Act of 1914
1957,The Copyright (Amendment) 1984,
The Copyright (Amendment) 1999
Trademark Act,1999 The Indian Patent Act,1970
1999;2002;2005
The Geographical Indications (Registration and Protection) Act, 1999 (48 of
1999)
The Design Act,2001
Protection of Plant Varieties and Farmers Act,2001
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Case Study
Novel health drink Made with extract from
plant indigenous From rural community Market intelligence
study indicators Strong for
international market
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Case Study Extract from an indigenous plant sp. Development of innovative process Authentication Validation for upscaling
Upscaling and leveraging Bulk requirements of bioresource Faster propagation methods Investments for R&D
Address the obligations in BD Act Prepare for protection thro patenting
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Case Study Value addition Market niche Rural communities Cross between
traditional practicesand upscaling
processes Design the containersfor marketing
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Case Study branding through Trademark-
Logo,jingles,
Copyright on literature Improved variety throughbiotechnologicalprocesses new variety
Propagation for tissueculture-patent Patent for isolated gene?
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IP protection form Product Legislation
Patent Agrochemicals,machinery, PHT ,novelgene,processes
IPA,1970;1999;2002;2005
New variety/extantvariety/farmers variety
distinct, uniform, stableplant grouping
PPVP&FR Act 2001
GI Products of specificterritorial origin
GI Act 1999
TD/TM/TS/copyright Agrochemicals,machinery, PHT,software
All Acts in place
Community rights Genetic resources, TK Biodiversity Act, 2002
Present Scenario: Current IP regime in India
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Subject Components Example IPRPlant Variety Germplasm Protected Variety Plant variety right
Selectable marker gene
Promoter Coding sequence
35SnptII
PatentPatent
Trait Promoter Coding sequence
TRcryIAb
PatentPatent
TransformationTechnology Ti-plasmid pGV226 Patent
Gene ExpressionTechnology[various regulatory elements and
modifications needed toexpress genes adequately in plant cells]
TranscriptionInitiationTranslation
InitiationCodon usage
viral leader Joshi AT -> GC
Patent-Patent
Number of IPRs 8
Case:Multiple IPRs related to the development of one insect protected plant
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Inventions not patentable(Patent Act 2002)
An invention which is frivolous or which claims anything obviously
contrary to well established natural laws[Sec 3 a]
An invention the primary or intended use or commercial exploitation
of which could be contrary public order or morality or which causes
serious prejudice to human, animal or plant life or health or to theenvironment [Sec 3 b]
The mere discovery of a scientific principle or the formulation of an
abstract theory or discovery of any living thing or non-living
substance occurring in nature [Sec 3 c]
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Inventions not patentable(Patent Act 2002) - Contd..
The mere discovery of any new property or new use for a knownsubstance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant [Sec 3 d]
A substance obtained by a mere admixture resulting only in theaggregation of the properties of the components thereof or aprocess of producing such substance [Sec 3 e]
There mere arrangement or re-arrangement or duplication of known
device each functioning independently of one another is a knownway [Sec 3 f]
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Inventions not patentable(Patent Act 2002) Contd..
A method of agriculture and horticulture[Sec 3 h] Any process for the medicinal, surgical, curative, prophylactic,
diagnostic, therapeutic or other treatment of human beings or processfor a similar treatment of animals to render them free of disease or to
increase their economic value or that of their products[Sec 3 i] Plants and animals in whole or any part thereof other than
microorganisms but including seeds, varieties and species andessentially biological process for production of propagation of plants andanimals; (The exclusions states other thanmicroorganisms suggesting that microorganisms in principle have not be excluded from patentability ) [Sec 3 j]
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Inventions not patentable(Patent Act 2002) - Contd..
A mathematical or business method or a computer program per se or algorithms;(This clarification relating to software is important as it suggests that if softwaresatisfies conditions of patentable inventions and are linked to applications, etc., their grant should not be rejected.) [Sec 3 k]
A literary, dramatic, musical or artistic work or any other aesthetic creationwhatsoever including cinematographic works and televisions productions[Sec
3 l] A mere scheme or rule or method of performing mental act or method of
playing game;[3m]
A presentation of information[Sec 3 n]
Topography of integrated circuits[Sec 3 o]
An invention which, in effect, is traditional knowledge or which is anaggregation or duplication of known properties of traditionally knowncomponent or components[Sec 3 p]
Section 5 of the Act, chemical process includes
biochemical, biotechnological and microbiological process
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Claims in gene patent applications may pertain to genes or partial DNA sequences,proteins encoded by these genes, vectors used for transfer of genes, genetically
modified micro-organisms, cells, plants and animals and the process of developinga transgenic product
These may lead to multiple rights owned by multiple actors, called patent thicketsover a final product
Problems of not only patent thickets, but also of royalty stacking and reach-throughclaims
The food sector in India will also have to face new challenges in the new patentregime
Different processes and products will become patentable.
There is, therefore, a need to document all the traditional processes as well as products,with a view to reduce the number of controversies over claims for patent rights.
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Patenting BiotechnologicalInventions
Are biotechnological inventions patentable ? New / novel Inventive step Industrial application Law of the land (non patentable
inventions - Morality)
Written Disclosure + Special disclosurerequirement
Deposit of Biological Materials
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Special Disclosure Requirement
A disclosure on genetic/ biological material in thespecification, when used in an invention required
Disclosure
Origin Source of genetic resources The specification shall be accompanied by anabstract to
provide technical information on the invention Access to the materialis available in the depository
institution only after the date of the application for patent inIndia or if a priority is claimed after the date of the priority
(In Section 10 of the IPA, 1970
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Deposit of Biological Materials International Depository Authority (IDA - 34)Budapest Treaty India MTCC,IMTECH, Chandigarh From October 4, 2002 MTCC, thus, become the 1st in India, 7th in Asia
and 34 in the world to acquire this status The deposit of the material shall be made not later than the
date of the patent application in India
What to deposit ?? GMOs, bacteria, viruses, cells, cell line, seeds, plasmids
Why deposit ??? Disclosure Viability- 30 years. Access
All the available characteristics of the material required for it to be correctly identified or indicated areincluded in the specification including the name, address of the depository institution and the dateand number of the deposit of the material at the institution
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Patentable biotechnologicalinventions
Biological material isolated from itsnatural environment or human body or
produced by a technical process
The industrial application / function of
a genetic material (eg : sequence or a partial sequence of a gene) must bedisclosed in the patent application
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Non Patentable biotechnological inventions The human body, at the
various stages of its formationand development, and thesimple discovery of one of itselements, eg: sequence or partial sequence of a gene(u/s 3j)
Plant and animal varieties(u/s 3j) Essentially biological
processes for the productionof plants or animals. (u/s 3j)
Invention whereincommercial exploitation wouldbe contrary to ordre public or morality (u/s 3b).
processes for cloninghuman beings (u/s 3b)
processes for modifyingthe germ line geneticidentity of humans or animals. (u/s 3b)
uses of human embryosfor industrial or commercial purposes; (u/s3b)
somatic gene and germline cell therapy (u/s 3i,3b)
Source:Bhanumathi,2006
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Patenting Track in ICAR Awareness
IP asset in personnel policies
In process for formulating IP policy
During 1995-2004, a total of 415 patents were granted in India
Of these, 250 patents were granted in the area of biocides, pest repellents and plant
growth regulators, while 165 patents were granted in the areas of plant reproduction,
horticulture, forestry, animal husbandry, harvesting, soil working, agricultural machineries
or implements, processing of harvesting produce, etc.
[Rai,M.2005. Need To Adopt Pro-active Partnership Mode In IPR
Management. http://www.icar.org.in/pr/27082005.htm ]
Nearly 40 patents granted to ICAR as assignee-
Indian Patent database
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Other IPRs and GIs
Oth er IPRs
Are essentiallyrewards for new
creations New Products or
Expressions or Marks or Designs
Mostly privatelyowned
GIs
Are not created butonly recognized
Already existingproducts with historyand reputation
Mostly owned by aGroup or Community
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Building GI as IP asset Can be developed into powerful
instrument
Especially in agriculture
Traditional varieties
goods ethnic knowledge-based
enterprises
Short-listing items for their
registration immediate need Scientific back-up needed as
evidence
Source: Tea Board of India
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A comparative study between Comt GI cheese and Emmenthal non -GI cheese in the Franche-Comt region of France
Demonstrates that the accrued benefits of GIs are distributed throughout the supply
chain. All of the part icipants milk
suppl ie rs , cheese producers and d is t r ibu tors a l ike benefi t from the GI name
Profitability of farms supplying milk for theComt GI is 32% higher than for farms
outside the GI production area Comparison between the two cheeses
shows that the price increase passed on tothe producer is 60% in the case of Comtagainst no increase in the case of Emmenthal
This is bec ause GIs require the es tab l i shment of a producer assoc ia t ion which i s ab le to negot iate , f rom a s t rong po s i t ion ,wi th the d is t r ibu tors and supermarkets who would o therwise monopol i se the pr ice increases
GIs are attached to traditions, and result in safer and more natural products
Was demon strated in the case of Comt, for example, that the use of fert i l izers and h erbicides is 2.5 t imes lower in the g eographical produc t ion areas than outsid e these areas
GIs are also instrumental in preventing rural exodusand preserving traditional ways of life.
The rate of rural exodus in the Comt product ion area i s a lmost 50% lower than outs ide, and almo st 30% low er than the average in France.
One poss ib le explanat ion for th i s i s the economic d ynamism and v i ta l ity tha t the GI Comt has injected into its region.
As an example , the number of job s per
l i t re of mi lk produ ced in the reg ion i s 5 t imes hig her than in the rest of France.
Source: http://jpn.cec.eu.int/home/showpage_en_event.eventobj53.1.php
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Impact on Rural Development
Economic impact Environmental impact Impact on Labor market Impact on Product distinction-TM
Impact on production Price premium Increased farm profitability Producers association: powerful negotiating tool Increased land value Production discipline
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Positive Indicator
The evidence of an emerging consensus a range of instruments and strategies is
necessary Question raised
Whether various IP rights mechanisms can provide adequate protection for
traditional knowledge practices
rural based innovations In the agricultural scenario
Toolbox at International level
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Treaty/Act Opportunities Obligations
CBD,1992 Sovereign rts of the States over their own biological resources
Conservation of biological diversitySustainable use of its componentsFair and equitable sharing of benefits
ITPGRFA,2001 Conservation,exploration,collection,char acterization,evaluation anddocumentation of PGR
Develop appr. measures for sustainable use of PFGRFAFarmers Rights-Art9-protectionsharing and decision makingEstablish multilateral system of
access and benefit sharing-Annex Icrops
Cartagena Protocol ,2000 Ensure protection in the safe-transfer,handling,use, disposal andtransboundary movement of LMOs
Advanced informed agreement of an importing country prior to thetrans-boundary transfer of LMOs
CITES,1975 Ensure int.trade in specimens of wildanimals and plants
Survival of such species should beallowed;Permits from concerned
UPOV,1978;1991 Protection of plant varieties by IPR Minimum rts granted to plantbreeders
FAO-CGIARAgreement,1994
Designated germplasm held in trust inCG centers
15 SGRP centers(FUTUREHARVEST)Multilateral access-Art 15 of ITPGRA
Toolbox at International level
T lb N i l l l
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Toolbox at National levelTreaty/Act Opportunities Obligations
BD Act,2002 Regulation,conservation,benefitsharing
Source of origin;PIC,ABS relatingto use of genetic resources
PVPFR Act ,2001 FR,RR,BR,Gene Fund,CR DUS testing;novelty,EDV
Indian Forest Act,1927;Wildlife Protection Act,1972;EnvironmentProtection Act,1986;Coastalregulation ZoneRules,1991;Andaman andNicobar Wildlife Protectionrules,1973
Diverse biodiversity-trade ranges fromlive animals/plants to products
MoEF-Reg.Deputy Directors(Wildlife Preservation) Issuepermits for tradeCMFRI- All others for protection of flora/fauna in India
Biosafety Clearing HouseMechanism -MoEF
National node for adhering tostipulations in CP
AIA;Biosafety clearing houseDocumentation-risks tobiodiversity addressed
Indian Patent Act,1970;1999;2002 &2005
novel innovations Disclosure of originNo grant for TK
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Present Progress Operational mechanisms and setting up of the
regulatory bodies now in process Indications towards creating an enabling
environment of actualizing and ensuringcomplementarities for positive synergiestowards building strong Intellectual Properties
(IPs) in agriculture
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Institutional Mechanisms
Biological Management Committee(BMC) [Section 41(1)]
Established at thelevel of Panchayats,Municipalities or CorporationsInvolvement of local people
State Biodiversity Board(SBB) [Section 22]
Consultative approach;State authorities, Academia, NGOs
National Biological Authority(NBA) [Section 8]
Protection of Plant Varieties and Farmers Rights Act
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Protection of Plant Varieties and Farmers Rights Authority established
NASC Complex, DPS Marg, Opp- Todapur, New Delhi-110 012 Objectives
Establishment of an effective system for protection of plant varieties
The rights of farmers and plant breeders
To encourage the development of new varieties of plants it hasbeen considered necessary to recognize and protect the rightsof the farmers in respect of their contribution made at any timein conserving, improving and making available plant genetic resources for the development of the new plant varieties
To accelerate agricultural development, it is necessary to protect plants breedersrights to stimulate investment for research and development for the development of new plant varietiesSuch protection is likely to facilitate the growth of the seed industry which willensure the availability of high quality seeds and planting material to the farmers
Protection of Plant Varieties and Farmers Rights Act,2001
Source: http://www.plantauthority.in
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Institutional Mechanism
Authority
Standing Committee
Other Committees
Tribunal
DUS test centers
CentralGovernment
Ministry of Agriculture
Registry
Court of Law
Registrar Office
Source; Trivedi,2006
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53 DUS test centres for 35 prioritized crops identified/equipped by ICAR
Digitalization has been almost completed using NBPGR software
Trainings carried out and continuing
National Test Guidelines ready for 12 crops through Task Force by the Authority.
National DUS Test Guidelines (Crop Specific) Table of ch aracteris t ics Grouping characteristics Asterisked characteristics Standard characteristics Other/additional characteristics Special characteristics
Suppor t ing evidence/character is t ics Technic a l inform at ion/ques t ionnai re
Reference collection Example varieties
Preparations
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Breeding of the Variety
Application
Announcementof Application
DUS Test
Registration of Variety
Payment of Registration Fee
Marketing
RejectionCorrection Order
Order to Change theDenomination
Notification of the reasonof refusal
Refusal
Cancellation of Registration
For other reasons
Variety Registration Approach
Benefit sharing / Gene fund
Source: Trivedi,2006
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TransferProcedures/Approvals/Documents EXIM policy = FTP MTA, SMTA IP
PC Third country quarantine DAC Approval
IBSC, RCGM, GEAC, Import clearance R&D Existing patents&their implications on
commercialization. Third party transfers
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Who Owns Biological Resources ?
Ownership travel from human right tosovereign rights of a nation. Farmers/individuals
National Bureaus NBPGR, NBAGR, NBFGR, NBAIM NAC - NR on HGR and Data.
National Biodiversity Authority State Biodiversity Board Biodiversity Monitoring Committee
[Source: Varaprasad,2006]
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Establishing ownership National
Germplasm Registration NBPGR Variety Registration PVPA Farmer Variety/Innovation PVPFRA;NIF SVRC CVRC
International
Variety/Germplasm - UPOV Innovation - PCT
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Research Transgenic rice Entry of golden rice in 2001
Debated relevance(?)
DBT;IPRB-pivotal role Rice model plant for cereal genomic research International rice genome sequencing project China,India beneficiaries of IPRB-24 inst participated
INRBN-1989 DNA sequences,constructs used originate from foreign and
int.research institutions, pvt companies who hold IPR No problem for R&D
Commercialization Indian institutions have to negotiatewith IPR holders-royalty,licensing
Documentation of Genetic Resources/Traditional Knowledge
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Documentation of Genetic Resources/Traditional Knowledge -I
Activity/Year Launched Agency Description
National Biodiversity and Strategy Action Plan,1999
M.o.E&FUNDPKalpravrikshBiotech Consortium, India
Assessment and stock-taking of biodiversity-related information atnat.and state levels
National Innovation Foundation
2000
DST
IIM
Register and support Grass
innovations
Biodiversity Plan Govt. of Karnataka State laws on biodiversity
Mission Mode Project oncollection,Documentation andvalidation of ITK
ICAR Documentation and registration of TK
TKDL CSIR Int. Library on TK
Peoples BiodiversityRegisters,1995
Foundation for Revitalization of Local Health Traditions
Records the status, uses andmanagement of living resources
Doc ment tion of Genetic Reso rces/Tr dition l Kno ledge
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NAIP-RKMP
Documentation of Genetic Resources/Traditional Knowledge -II
Activity/Year Launched Agency Description
CBR,1995 IISc Provided spaces for the rights tocommunities about their biologicaland cultural heritage
Conservation movement Research Foundation for
Science,Technology and Ecology
Agro-biological conservation of
indigenous varieties ;32 communityseed banks
Movement for securing benefits for local communities
Gene Campaign Collecting, characterizing trad.Varieties/local land races,mappinglocation of wild relatives with helpof local communities,herbalgardens,,CoFab
-Do- Several other NGOs,peoplesmovement formal/informal
Recognition of TK/practices,conservation,identifying holders of knowledge,support to unorganizedpickets of TK/IK
US patent new strain of fragrant Pathum Thani rice
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US patent new strain of fragrant Pathum Thani rice Prathum Thani 1 developed from Kao Dok Mali 105 fragrant rice, better known
as Hom Mali rice, by the department in 2000 The new high-grade rice strain is said to be less fragrant but
just as tasty as jasmine rice
The rice is resistant to pests and diseases and can begrown year-round
US Patent for Thailand's Pathum Thani 1 rice strainunder its plant variety protection law
Biopiracy threat averted-prior art By obtaining the patent in the US, plant breeders and rice
farmers in other countries, including America, cannot beallowed to make use of the rice strain. Thailand will now become the only country in the world
that can export Pathum Thani 1 rice to the USSource: Kultida Samabuddhi Bangkok Post | 14 January 2004
A l
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An example Golden rice, a rice plant into which three foreign genes
(two from the daffodil and one from a bacteria) have beenintroduced so that it produces pro-vitamin A. The plantvariant was produced by researchers collaborating inSwitzerland and Germany.
There is large interest in making it available to farmers indeveloping countries.
However, the number of concurrent patents has complicatedthis possibility. Seventy techniques and materials used indeveloping the variant are patented and are owned by 32different parties.
Yet the technology is available in public domain.
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NAIP-RKMP
Desiderata something necessary or desirable Research has to come out of its sheltered existence to face an
era of competitiveness Create documentary evidence or other forms available in public domain to
create and establish Prior Art
Document all the traditional processes as well as products, with a view toreduce the number of controversies over claims for patent rights.
Awareness on patent granting system especially in India
Rapport /Partnership with local regulatory bodies
Technological backstopping especially for benefit sharing
Registration of germplasm through national systems including elite germplasm
Registration of plant varieties-extant varieties
Identifying prospective GI
St t f B l i I t t ti
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Strategy of Balancing Interests continues
StakeHolders
Profit vsLivelihood
North vs
South
Knowledge vsIgnorance
Indigenousvs Imported
Protectionismvs
Free Trade
IPRights
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NAIP RKMP R Kalpana Sastry
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