basics of ip

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Basics of International and Indian System of

IP protection



Nov. 19,2008 2

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 3

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 4

Indian NARS

Public sector - ICAR, AUs, Universities, departments A strong element of private and voluntary organizations

Large commercial companies with their own R&Dcapabilities

Linkages/complementarily between componentsbecoming strong

6,428 scientific-ICAR; around 30,000 scientists in NARS



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


Transgenic

biotechnologies


Scientific research

Plant breeding





Nov. 19,2008 7


Transgenic

biotechnologies


Scientific research

Plant /Animal breeding





Nov. 19,2008 8


Transgenic

biotechnologies


Scientific research

Plant Animal breeding





Nov. 19,2008 9


Transgenic

biotechnologies


Scientific research






Nov. 19,2008 10


Transgenic

biotechnologies


Scientific research




GR:fundamental resource;endless activity of breeding;vital to food security



Nov. 19,2008 11

Fear of Imbalanced Balances !

Agrigoods in Trade

Agrigoods in TradeWTO

WTO



Nov. 19,2008 12

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 13

Article 27.1 states

Patent shall be available for any invention,

whether products or processes, in all fields of

technology, provided they are new, involve an

inventive step (non-obviousness) and are capable

of industrial application (useful). ± Subject to para 4 of Article 65(2), para 8 of Article 70(3)

and para 3 of this Article, patents shall be available, and

patent rights enjoyable without discrimination as to the

place of invention, the field of technology and whether

products are imported or locally produced



Nov. 19,2008 14

Article 27.2 states

Members may exclude from patentability inventions,

the prevention within their territory of the

commercial exploitation of which is necessary to

protect order public or morality, including to protect

human, animal or plant life or health or to avoid

serious prejudice to the environment, provided that

such exclusion is not made merely because the

exploitation is prohibited by domestic law



Nov. 19,2008 15

Article 27.3 states

Members may exclude from patentability

± Diagnostic, therapeutic and surgical methods for treatment of

humans or animals;

± Plants and animals other than microorganisms, and essentially

biological processes for the production of plants or animals other

than non-biological and microbiological process. However, Members

shall provide for the protection of plant varieties either by patents or

by an effective sui generis system or by any combination thereof



Nov. 19,2008 16

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 17

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 18

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 19

Case Study

Extract from an

indigenous plant sp.

Development of innovative process

Authentication

Validation for upscaling



Nov. 19,2008 20

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 21

Case Study

Value addition

Market niche

Rural communities

Cross between traditional

practices and upscaling

processes

Design the containers for

marketing



Nov. 19,2008 22

Case Study

branding through

Trademark-

± Logo,jingles,

Copyright on literature

Improved variety throughbiotechnological processes

new variety

Propagation for tissue culture-

patent

Patent for isolated gene?



Nov. 19,2008 23

Present Scenario: Current IP regime in India

IP protection form Product Legislation

Patent Agrochemicals,

machinery, PHT

,novel

gene,processes

IPA,1970;1999;2002;20

05

New variety/extant

variety/farmers variety

distinct, uniform,

stable plantgrouping

PPVP&FR Act 2001

GI Products of specific

territorial origin

GI Act 1999

TD/TM/TS/copyright Agrochemicals,

machinery, PHT,software

All Acts in place

Community rights Genetic resources,

TK

Biodiversity Act, 2002



Nov. 19,2008 24

Case:Multiple IPRs related to the development of one insect protected plant

Subject Components Example IPR

Plant Variety Germplasm Protected VarietyPlant variety

right

Selectable

marker gene

Promoter

Coding sequence

35S

nptII

Patent

Patent

Trait Promoter

Coding sequence

TR

cryIAb

Patent

Patent

TransformationTe

chnologyTi-plasmid pGV226 Patent

Gene Expression

Technology[various regulatory

elements and

modifications needed to

express genes

adequately in plant

cells]

Transcription

Initiation

Translation

InitiationCodon usage

viral leader

Joshi

AT -> GC

Patent

-

Patent

Number of IPRs 8

IPR & WTO Related Issues (sponsored by the DST) August 1,2007



Nov. 19,2008 25

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 26

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 27

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 ot her t han microorganisms suggesting t hat

microorganisms in principle have not be excluded from patentability ) [Sec 3 j]



Nov. 19,2008 28

Inventions not patentable(Patent Act 2002) - Contd..

A mathematical or business method or a computer program per se oralgorithms; ( This clarification relating to software is important as it suggests t hat if software

satisfies conditions of patentable inventions and are linked to applications, etc., t heir 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 29

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 Asiaand 34 in the world to acquire this status

The deposit of t he material shall be made not later t han t he

date of t he patent application in India

What to deposit ?? GMOs, bacteria, viruses, cells,

cell line, seeds, plasmids

± Why deposit ???

Disclosure

Viability- 30 years.

Access



Nov. 19,2008 30

Other IPRs and GIs

Other IPRs

Are essentially

rewards for new

creations

New Products or

Expressions or

Marks or Designs

Mostly privately

owned

GIs

Are not created but only

recognized

Already existing products

with history and

reputation

Mostly owned by a

Group or Community



Nov. 19,2008 31

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 32

Positive Indicator

The evidence of an emerging consensus ± a range of instruments and strategies is necessary

Question raised

± Whether various IP rights mechanisms can provideadequate protection for

traditional knowledge

practices

rural based innovations

In the agricultural scenario




Nov. 19,2008 33

Institutional Mechanisms

Biological Management Committee

(BMC) [Section 41(1)]

Established at the

level of Panchayats,

Municipalities or

Corporations

Involvement of

local people

State Biodiversity Board

(SBB) [Section 22]

Consultative approach;

State authorities,

Academia, NGOs

NationalBiological Authority(NBA) [Section 8]




Nov. 19,2008 34

Cross-over?

IPR Private domain

Exclusive Right

Human Knowledge and skill

oriented

Principally concerned with

novelty, distinctiveness and the

market

Resources Exploitation,

manipulation focus

Application of human

knowledge and skill having

commercial value

BIODIVERSITY

Public Domain

Common Resource

Not dependent on human knowledge

& skill

Endowed with life ± Principally subject to natural

processes of birth, death, and

renewal

Resource conservation focus

Not perceived as an economic

resource biosafety and ecologicalintegrity are of paramount

consideration



Nov. 19,2008 35

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 thedevelopment 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

Protection of Plant Varieties and Farmers Rights Act, 2001

Source: http://www.plantauthority.inIPR & WTO Related Issues (sponsored by the DST) August 1,2007



Nov. 19,2008 36

Institutional Mechanism

Authority

Standing Committee

Other Committees

Tribunal

DUS test centers

Central

Government

Ministry of Agriculture

Registry

Court of Law

Registrar Office

Source; Trivedi,2006



Nov. 19,2008 37

Breeding of the Variety

Application

Announcement

of Application

DUS Test

Registration of Variety

Payment of Registration Fee

Marketing

RejectionCorrection Order

Order to Change the

Denomination

Notification of the reason

of refusal

Refusal

Cancellation of

Registration

For other reasons

VarietyRegistration Approach

Benefit sharing / Gene fund

Source: Trivedi,2006



Nov. 19,2008 38

Documentation of Genetic Resources/Traditional Knowledge -I

Activity/Year Launched Agency Description

National Biodiversity and

Strategy Action Plan,1999

M.o.E&F

UNDP

Kalpravriksh

Biotech Consortium, India

Assessment and stock-taking

of biodiversity-related

information at nat.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 on

collection,Documentation and

validation of ITK

ICAR Documentation and

registration of TK

TKDL CSIR Int. Library on TK

People¶s Biodiversity

Registers,1995

Foundation for Revitalization

of Local Health Traditions

Records the status, uses and

management of living

resources



Nov. 19,2008 39

Documentation of Genetic Resources/Traditional Knowledge -II


CBR,1995 IISc Provided spaces for the rights

to communities about their

biological and cultural heritage

Conservation movement Research Foundation for

Science,Technology andEcology

Agro-biological conservation of

indigenous varieties ;32community seed banks

Movement for securing

benefits for local communities

Gene Campaign Collecting, characterizing trad.

Varieties/local land

races,mapping location of wild

relatives with help of local

communities,herbal

gardens,,CoFab

-Do- Several other NGO¶s,peoples

movement ±formal/informal

Recognition of

TK/practices,conservation,

identifying holders of

knowledge,support to

unorganized pickets of TK/IK




Nov. 19,2008 40

Documentation of Genetic Resources/Traditional Knowledge -III


Honey Bee

Network,1996National

Biodiversity and Strategy Action

Plan,1999

Sristi Document innovative practices

of farmers/artisans

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

SSB (Kerala, MP,WB Models)

Formation of PBR and BMC for

conservation,sustainable use

and equitable sharing of benefits

of Biological Resources



Nov. 19,2008 41

Strategy of Balancing Interests continues

StakeHolders

Profit

vsLivelihood Nort

h vsSouth

Knowledge vsIgnorance

Indigenousvs Imported

Protectionismvs

Free Trade

IPRights




Nov. 19,2008 42

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