Nandini Kotharkar

7/27/2019 Nandini Kotharkar

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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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Scientific research

Plant breeding





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Scientific research

Plant /Animal breeding





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Scientific research

Plant Animal breeding





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Scientific research






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Scientific research





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
http://www.icar.org.in/pr/27082005.htmhttp://www.icar.org.in/pr/27082005.htm


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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
http://jpn.cec.eu.int/home/showpage_en_event.eventobj53.1.phphttp://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
http://www.plantauthority.in/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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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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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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