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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;1 NoG;1autonomous institute Out of 10 on GM crops four on rice
Source:Indira et al,2005
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Industrial application
Scientific research
Plant breeding
Industrial application
Scientific research
Plant breeding
Industrial application
Scientific research
Plant /Animal breeding
Industrial application
Scientific research
Plant Animal breeding
Industrial application
Scientific research
Plant /Animal breeding
Industrial application
Scientific research
Plant /Animal breeding
WTO
Agrigoods in Trade
WTO
Agrigoods in Trade
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The Convention on Biological Diversity 1992 (CBD) Global Plan of Action 1996 (GPA) The International Treaty on Plant Genetic Resources for Food and Agriculture 2001 (ITPGRFA) Convention on International Trade in Endangered Species of Wild Fauna and Flora 1975 (CITES) World Trade Organization (WTO) Agreements such as Trade Related Aspects in 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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Geographical Indications Industrial Designs Integrated Circuits Trade Secrets Plant Varieties
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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 practices and upscaling processes Design the containers for marketing
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Case Study
branding through Trademark Logo,jingles,
Copyright on literature Improved variety through biotechnological processes new variety Propagation for tissue culture-patent Patent for isolated gene?
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distinct, uniform, stable PPVP&FR Act 2001 plant grouping Products of specific territorial origin Agrochemicals, machinery, PHT, software Genetic resources, TK GI Act 1999 All Acts in place
Community rights
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Case:Multiple IPRs
Subject Components
Plant Variety
Selectable marker gene Trait TransformationTech nology Gene Expression Technology
[various regulatory elements and modifications needed to express genes adequately in plant cells]
Germplasm
Promoter Coding sequence Promoter Coding sequence Ti-plasmid Transcription Initiation Translation Initiation Codon usage
Protected Variety
35S nptII TR cryIAb pGV226 viral leader Joshi AT -> GC
Number of IPRs
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Until
the strength of a companys classical breeding programme. But with the advent of the first transgenic plants, such breeding, as well as access to germplasm, genes and biotechnologies have become of considerable strategic importance. Genetic material, biotechnologies and their associated intellectual property rights (IPRs) are in fact leading to a new restructuring of the relations between agrochemical, agrobiotechnological, food processing, and seed companiesSehgal, S. (1996), "IPR Driven Restructuring of the Seed
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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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- Contd..
The mere discovery of any new property or new use for a known substance 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 the aggregation of the properties of the components thereof or a process 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 known way [Sec 3 f]
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A literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever 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]
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 developing a transgenic product These may lead to multiple rights owned by multiple actors, called patent thickets over a final product Problems of not only patent thickets, but also of royalty stacking and reach-through claims The food sector in India will also have to face new challenges in the new patent regime 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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A disclosure on genetic/ biological material in the specification, when used in an invention required Disclosure
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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
processes for cloning human beings (u/s 3b) processes for modifying the germ line genetic identity of humans or animals. (u/s 3b) uses of human embryos for industrial or commercial purposes; (u/s 3b) somatic gene and germ line cell therapy (u/s 3i, 3b)
Source:Bhanumathi,2006
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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
A comparative study between Comt GI cheese and Emmenthal nonGI cheese in the Franche-Comt region of France
Demonstrates that the accrued benefits of GIs are distributed throughout the supply chain.
All of the participants milk suppliers, cheese producers and distributors alike benefit from the GI name
GIs are attached to traditions, and result in safer and more natural products
Was demonstrated in the case of Comt, for example, that the use of fertilizers and herbicides is 2.5 times lower in the geographical production areas than outside these areas
Profitability of farms supplying milk for the Comt GI is 32% higher than for farms outside the GI production area Comparison between the two cheeses shows that the price increase passed on to the producer is 60% in the case of Comt against no increase in the case of Emmenthal
This is because GIs require the establishment of a producer association which is able to negotiate, from a strong position, with the distributors and supermarkets who would otherwise monopolise the price increases NAIP-RKMP
GIs are also instrumental in preventing rural exodus and preserving traditional ways of life.
The rate of rural exodus in the Comt production area is almost 50% lower than outside, and almost 30% lower than the average in France. One possible explanation for this is the economic dynamism and vitality that the GI Comt has injected into its region. As an example, the number of jobs per litre of milk produced in the region is 5 times higher than in the rest of France.
Source: http://jpn.cec.eu.int/home/showpage_en_event.eventobj53.1.php
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
ITPGRFA,2001
Advanced informed agreement of an importing country prior to the trans-boundary transfer of LMOs
Survival of such species should be allowed;Permits from concerned Minimum rts granted to plant breeders 15 SGRP centers(FUTURE HARVEST) Multilateral access-Art 15 of ITPGRA
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BD Act,2002
PVPFR Act ,2001 Indian Forest Act,1927;Wild life Protection Act,1972;Environment Protection Act,1986;Coastal regulation Zone Rules,1991;Andaman and Nicobar Wildlife Protection rules,1973 Biosafety Clearing House Mechanism -MoEF Indian Patent Act,1970;1999;2002 &2005
Regulation,conservation,benefit sharing
FR,RR,BR,Gene Fund,CR Diverse biodiversity-trade ranges from live animals/plants to products
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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 ensuring complementarities for positive synergies towards building strong Intellectual Properties (IPs) in agriculture
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Institutional Mechanisms
National Biological Authority
(NBA) [Section 8]
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Source: http://www.plantauthority.in
Institutional Mechanism
Authority
Central Government
Ministry of Agriculture
Registrar Office
Registry
Tribunal
Standing Committee
Court of Law
Source; Trivedi,2006
Preparations
53 DUS test centres for 35 prioritized crops identified/equipped by ICAR Digitalization has been almost completed using NBPGR software
Application Correction Order Announcement of Application Order to Change the Denomination DUS Test Notification of the reason of refusal Registration of Variety Refusal Payment of Registration Fee Cancellation of Registration For other reasons Benefit sharing / Gene fund
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Rejection
Marketing
Source: Trivedi,2006
Transfer Procedures/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 to sovereign rights of a nation. Farmers/individuals National Bureaus
NBPGR, NBAGR, NBFGR, NBAIM
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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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
National Innovation Foundation 2000 Biodiversity Plan Mission Mode Project on collection,Documentation and validation of ITK TKDL Peoples Biodiversity Registers,1995
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Register and support Grass innovations State laws on biodiversity Documentation and registration of TK Int. Library on TK Records the status, uses and management of living resources
Conservation movement
-Do-
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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 been introduced so that it produces pro-vitamin A. The plant variant was produced by researchers collaborating in Switzerland and Germany. There is large interest in making it available to farmers in developing countries. However, the number of concurrent patents has complicated this possibility. Seventy techniques and materials used in developing the variant are patented and are owned by 32 different parties. Yet the technology is available in public domain.
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Desiderata
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 to reduce 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
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Profit vs Livelihood
IP Rights
Stake Holders
North vs South
Indigenous vs Imported
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Knowledge vs Ignorance
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R.Kalpana Sastry
NAARM