Basics of International and Indian System of IP Protection

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Basics of International and Indian System of

IP protection
Plan of Presentation
• Indian Agriculture today
• IPR-what is it?
– Various Forms
• Regulatory mechanisms at national level
– Their relevance to agriculture
• IPR vis-à-vis Indian Agriculture

Nov. 19,2008 2
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

Nov. 19,2008 3
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

Nov. 19,2008 4
The Pyramid of Knowledge

Transgenic
biotechnologies

Industrial application

Scientific research

Plant breeding

Traditional agriculture / associated T.K

Maintenance of natural biodiversity / associated T.K

Nov. 19,2008 5
The Pyramid of Knowledge

Transgenic
biotechnologies

Industrial application

Scientific research

Plant breeding

Traditional agriculture / associated T.K

Maintenance of natural biodiversity / associated T.K

Nov. 19,2008 6
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

Nov. 19,2008 7
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

Nov. 19,2008 8
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

Nov. 19,2008 9
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 resource;endless activity of breeding;vital to food security

Nov. 19,2008 10
Fear of Imbalanced Balances !

WTO

Agrigoods in Trade
Agrigoods in Trade
WTO

Nov. 19,2008 11
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)

Nov. 19,2008 12
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]

Nov. 19,2008 16
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
• The Semiconductor Integrated Circuits Layout-Design Act, 2000
• The Protection of Plant Varieties and Farmers Act,2001

Nov. 19,2008 17
Case Study
• Novel health drink
• Made with extract from
plant indigenous
• From rural community
• Market intelligence study
indicators
– Strong for international
market

Nov. 19,2008 18
Case Study

• Extract from an
indigenous plant sp.
• Development of
innovative process
• Authentication
• Validation for
upscaling

Nov. 19,2008 19
Case Study
• 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

Nov. 19,2008 20
Case Study
• Value addition
• Market niche
• Rural communities
• Cross between traditional
practices and upscaling
processes
• Design the containers for
marketing

Nov. 19,2008 21
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?

Nov. 19,2008 22
Present Scenario: Current IP regime in India

IP protection form Product Legislation


Patent Agrochemicals, IPA,1970;1999;2002;20
machinery, PHT 05
,novel
gene,processes
New variety/extant distinct, uniform, PPVP&FR Act 2001
variety/farmers variety stable plant
grouping
GI Products of specific GI Act 1999
territorial origin

TD/TM/TS/copyright Agrochemicals, All Acts in place


machinery, PHT,
software
Community rights Genetic resources, Biodiversity Act, 2002
TK

Nov. 19,2008 23
Case:Multiple IPRs related to the development of one insect protected plant 

Subject  Components Example IPR 


Plant variety
Plant Variety  Germplasm Protected Variety
right 
Selectable Promoter  35S  Patent 
marker gene Coding sequence nptII  Patent 
Trait Promoter  TR  Patent 
Coding sequence cryIAb Patent 
TransformationT
Ti-plasmid pGV226 Patent 
echnology
Gene Expression Transcription viral leader  Patent 
Technology Initiation  Joshi  - 
[various regulatory Translation AT -> GC Patent 
elements and
modifications needed to Initiation 
express genes Codon usage
adequately in plant
cells]

  Number of IPRs 8

IPR & WTO Related Issues (sponsored by the DST)


Nov. 19,2008 24
August 1,2007
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]

Nov. 19,2008 25
Inventions not patentable
(Patent Act 2002) - 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]

Nov. 19,2008 26
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]

Nov. 19,2008 27
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
Nov. 19,2008 28
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 ??
• GMO’s, bacteria, viruses, cells,
• cell line, seeds, plasmids
– Why deposit ???
• Disclosure
• Viability- 30 years.
• Access

Nov. 19,2008 29
Other IPRs and GIs

Other IPRs GIs


• Are essentially • Are not created but only
rewards for new recognized
creations • Already existing products
• New Products or with history and
Expressions or reputation
Marks or Designs • Mostly owned by a
• Mostly privately Group or Community
owned

Nov. 19,2008 30
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

Nov. 19,2008 31
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

Nov. 19,2008 IPR & WTO Related Issues (sponsored by the DST) 32
August 1,2007
Institutional Mechanisms
National Biological Authority
(NBA) [Section 8]

•Consultative approach;
State Biodiversity Board •State authorities,
(SBB) [Section 22] •Academia, NGOs

•Established at the
level of Panchayats,
Municipalities or
Biological Management Committee Corporations
(BMC) [Section 41(1)] •Involvement of
local people

Nov. 19,2008 IPR & WTO Related Issues (sponsored by the DST) 33
August 1,2007
Cross-over?

IPR BIODIVERSITY
• Private domain • Public Domain
• Exclusive Right • Common Resource
• Not dependent on human
• Human Knowledge and skill
knowledge & skill
oriented
• Endowed with life –
• Principally concerned with – Principally subject to natural
novelty, distinctiveness and the processes of birth, death, and
renewal
market
• Resource conservation focus
• Resources Exploitation,
• Not perceived as an “economic
manipulation focus resource” – biosafety and ecological
• Application of human integrity are of paramount
knowledge and skill having consideration
commercial value

Nov. 19,2008 34
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

Nov. 19,2008 IPR & WTO Related Issues (sponsored by the DST) Source: http://www.plantauthority.in
35
August 1,2007
Institutional Mechanism

Authority
Central
Government
Registrar Office
Ministry of Agriculture

Registry
Tribunal

Standing Committee
Court of Law DUS test centers

Other Committees

Nov. 19,2008 Source; Trivedi,2006 36


Breeding of the Variety Variety Registration Approach

Application

Correction Order Rejection


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
Marketing

Benefit sharing / Gene fund

Nov. 19,2008 37
Source: Trivedi,2006
Documentation of Genetic Resources/Traditional Knowledge -I

Activity/Year Launched Agency Description

National Biodiversity and M.o.E&F Assessment and stock-taking


Strategy Action Plan,1999 UNDP of biodiversity-related
information at nat.and state
Kalpravriksh
levels
Biotech Consortium, India

National Innovation DST Register and support Grass


Foundation 2000 IIM innovations

Biodiversity Plan Govt. of Karnataka State laws on biodiversity

Mission Mode Project on ICAR Documentation and


collection,Documentation and registration of TK
validation of ITK

TKDL CSIR Int. Library on TK

People’s Biodiversity Foundation for Revitalization Records the status, uses and
Registers,1995 of Local Health Traditions management of living
resources

Nov. 19,2008 38
Documentation of Genetic Resources/Traditional Knowledge -II

Activity/Year Launched Agency Description

CBR,1995 IISc Provided spaces for the rights


to communities about their
biological and cultural heritage

Conservation movement Research Foundation for Agro-biological conservation of


Science,Technology and indigenous varieties ;32
Ecology community seed banks

Movement for securing Gene Campaign Collecting, characterizing trad.


benefits for local communities Varieties/local land
races,mapping location of wild
relatives with help of local
communities,herbal
gardens,,CoFab

-Do- Several other NGO’s,peoples Recognition of


movement –formal/informal TK/practices,conservation,
identifying holders of
knowledge,support to
unorganized pickets of TK/IK

Nov. 19,2008 IPR & WTO Related Issues (sponsored by the DST) 39
August 1,2007
Documentation of Genetic Resources/Traditional Knowledge -III

Activity/Year Launched Agency Description

Honey Bee Sristi Document innovative practices


Network,1996National of farmers/artisans
Biodiversity and Strategy Action
Plan,1999

Database MSSRF Document contributions of tribal


groups for securing benefits

Biodiversity Plan Govt. of Karnataka State laws on biodiversity

Village Registry,1997 Pattuvam Village,Kerala Produced a registry of GR in


their village and declared it their
property

TKDL CSIR Int. Library on TK

PBR,2005 NBA Formation of PBR and BMC for


SSB (Kerala, MP,WB Models) conservation,sustainable use
and equitable sharing of benefits
of Biological Resources

Nov. 19,2008 40
Strategy of Balancing Interests continues

Profit vs North vs
Livelihood IP Stake South
Rights Holders

Protectionism
Indigenous Knowledge vs vs
vs Imported Ignorance Free Trade
Nov. 19,2008 IPR & WTO Related Issues (sponsored by the DST) 41
August 1,2007
Nov. 19,2008 42

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