Intellectual Property Rights Issues in WTO regime

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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The Pyramid of Knowledge

Transgenic biotechnologies

Industrial application

Scientific research
Plant breeding

Traditional agriculture / associated T.K

Maintenance of natural biodiversity / associated T.K
NAIP-RKMP

The Pyramid of Knowledge

Transgenic biotechnologies

Industrial application

Scientific research
Plant breeding

Traditional agriculture / associated T.K

Maintenance of natural biodiversity / associated T.K
NAIP-RKMP

The Pyramid of Knowledge

Transgenic biotechnologies

Industrial application

Scientific research
Plant /Animal breeding

Traditional agriculture / associated T.K

Maintenance of natural biodiversity / associated T.K
NAIP-RKMP

The Pyramid of Knowledge

Transgenic biotechnologies

Industrial application

Scientific research
Plant Animal breeding

Traditional agriculture / associated T.K

Maintenance of natural biodiversity / associated T.K
NAIP-RKMP

The Pyramid of Knowledge

Transgenic biotechnologies

Industrial application

Scientific research
Plant /Animal breeding

Traditional agriculture / associated T.K

Maintenance of natural biodiversity / associated T.K
NAIP-RKMP

The Pyramid of Knowledge

Transgenic biotechnologies

Industrial application

Scientific research
Plant /Animal breeding

Traditional agriculture / associated T.K

Maintenance of natural biodiversity / associated T.K GR:fundamental NAIP-RKMP resource;endless activity of breeding;vital to food security

Fear of Imbalanced Balances !

WTO
Agrigoods in Trade

WTO

Agrigoods in Trade

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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 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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Part II: Forms /Elements of IP

Copyright Trademark Patents Other IPs

Geographical Indications Industrial Designs Integrated Circuits Trade Secrets Plant Varieties

[Pertain to Part II : Standards of IPRs (Art. 9 to 40) (Sec. 1 to 8) of TRIPS including

control of anti-competitive practices in contractual licenses]

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Has India amended its legislations as per TRIPS?

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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Agreements and contracts

Principles of prior informed consent (PIC) Mutually agreed terms (MAT)
which can pave for amicable modus operandi in the highly complex and dynamic environment of high-end agricultural research leading to development of technological innovations and products

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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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Present Scenario: Current IP regime in India

IP protection form Patent Product Agrochemicals, machinery, PHT ,novel gene,processes Legislation IPA,1970;1999;2002;2005

New variety/extant variety/farmers variety GI TD/TM/TS/copyright

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

Biodiversity Act, 2002

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Case:Multiple IPRs
Subject Components

related to the development of

IPR

one insect protected plant

Example

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

Plant variety right

Patent Patent Patent Patent Patent Patent Patent

Number of IPRs
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Until

recently, success in the seed business could be traced to

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

Industry." Biotechnology and Development Monitor, No. 29,

p. 1821

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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 the environment [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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(Patent Act 2002)

Inventions not patentable

- 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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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 process for 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 and essentially biological process for production of propagation of plants and animals; (The exclusions states other than microorganisms 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 software
satisfies 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 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]

Topography of integrated circuits[Sec 3 o]

An invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components [Sec 3 p]
Section 5 of the Act, chemical process includes biochemical, biotechnological and microbiological process NAIP-RKMP

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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Patenting Biotechnological Inventions

Are biotechnological inventions patentable ?
New / novel Inventive step Industrial application Law of the land (non patentable inventions - Morality) Written Disclosure + Special disclosure requirement Deposit of Biological Materials
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Special Disclosure Requirement

(In Section 10 of the IPA, 1970

A disclosure on genetic/ biological material in the specification, when used in an invention required Disclosure

Origin Source of genetic resources

The specification shall be accompanied by an abstract to provide technical information on the invention Access to the material is available in the depository institution only after the date of the application for patent in India or if a priority is claimed after the date of the priority

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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 are included in the specification including the name, address of the depository institution and the date and number of the deposit of the material at the institution NAIP-RKMP

Patentable biotechnological inventions

Biological material isolated from its natural 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 be disclosed in the patent application
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Non Patentable biotechnological inventions

The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, eg: sequence or partial sequence of a gene (u/s 3j) Plant and animal varieties (u/s 3j) Essentially biological processes for the production of plants or animals. (u/s 3j) Invention wherein commercial exploitation would be contrary to ordre public or morality (u/s 3b).
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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

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

Other IPRs Are essentially rewards for new creations GIs Are not created but only recognized

New Products or Expressions or Marks or Designs Mostly privately owned

Already existing products with history and reputation

Mostly owned by a Group 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
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Source: Tea Board of India

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

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

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Toolbox at International level

Treaty/Act CBD,1992 Opportunities Sovereign rts of the States over their own biological resources Obligations Conservation of biological diversity Sustainable use of its components Fair and equitable sharing of benefits Develop appr. measures for sustainable use of PFGRFA Farmers Rights-Art9-protection sharing and decision making Establish multilateral system of access and benefit sharing-Annex I crops

ITPGRFA,2001

Conservation,exploration,collection,char acterization,evaluation and documentation of PGR

Cartagena Protocol ,2000

Ensure protection in the safetransfer,handling,use, disposal and transboundary movement of LMOs

Ensure int.trade in specimens of wild animals and plants Protection of plant varieties by IPR Designated germplasm held in trust in CG centers

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

CITES,1975 UPOV,1978;1991 FAO-CGIAR Agreement,1994

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Toolbox at National level

Treaty/Act Opportunities Obligations

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

Source of origin;PIC,ABS relating to use of genetic resources

DUS testing;novelty,EDV MoEF-Reg.Deputy Directors (Wildlife Preservation) Issue permits for trade CMFRIAll others for protection of flora/fauna in India AIA;Biosafety clearing house Documentation-risks to biodiversity addressed Disclosure of origin No grant for TK

National node for adhering to stipulations in CP novel innovations

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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]

State Biodiversity Board (SBB) [Section 22]

Consultative approach; State authorities, Academia, NGOs

Biological Management Committee (BMC) [Section 41(1)]

Established at the level of Panchayats, Municipalities or Corporations Involvement of local people

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Protection of Plant Varieties and Farmers Rights Act, 2001

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 has been considered necessary to recognize and protect the rights of the farmers in respect of their contribution made at any time in 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 breeders rights to stimulate investment for research and development for the development of new plant varieties Such protection is likely to facilitate the growth of the seed industry which will ensure the availability of high quality seeds and planting material to the farmers
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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

DUS test centers

Other Committees
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Source; Trivedi,2006

Preparations
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 characteristics
Grouping characteristics Asterisked characteristics Standard characteristics Other/additional characteristics Special characteristics

Supporting evidence/characteristics Technical information/questionnaire

Reference collection Example varieties

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Breeding of the Variety

Variety Registration Approach

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

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 negotiate with IPR holders-royalty,licensing

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Documentation of Genetic Resources/Traditional Knowledge -I

Activity/Year Launched National Biodiversity and Strategy Action Plan,1999 Agency M.o.E&F UNDP Kalpravriksh Biotech Consortium, India DST IIM Govt. of Karnataka ICAR Description Assessment and stock-taking of biodiversity-related information at nat.and state levels

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

CSIR Foundation for Revitalization of Local Health Traditions

Documentation of Genetic Resources/Traditional Knowledge -II

Activity/Year Launched CBR,1995 IISc Agency Description Provided spaces for the rights to communities about their biological and cultural heritage Agro-biological conservation of indigenous varieties ;32 community seed banks Collecting, characterizing trad. Varieties/local land races,mapping location of wild relatives with help of local communities,herbal gardens,,CoFab Recognition of TK/practices,conservation, identifying holders of knowledge,support to unorganized pickets of TK/IK

Conservation movement

Research Foundation for Science,Technology and Ecology Gene Campaign

Movement for securing benefits for local communities

-Do-

Several other NGOs,peoples movement formal/informal

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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 be grown year-round US Patent for Thailand's Pathum Thani 1 rice strain under 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 be allowed 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 US
Source: Kultida Samabuddhi Bangkok Post | 14 January 2004
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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

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 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

NAIP-RKMP

Strategy of Balancing Interests continues

Profit vs Livelihood

IP Rights

Stake Holders

North vs South

Indigenous vs Imported
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Knowledge vs Ignorance

Protectionism vs Free Trade

NAIP-RKMP

R.Kalpana Sastry
NAARM