IPR in PGR management

Sanjeev Saxena

Assistant Director General

Indian Council of Agricultural Research

New Delhi

Training on Management of Plant Genetic Resources organized

by NBPGR, New Delhi, held on 13 March 2018

Intellectual Property Rights

- Intellect - tangible - role of state

- Intangible - does not diminish - legal domain

with use - monopoly right

IPRs are legal rights that are conferred by the state

to the owner of an intellectual creation that is

original and not existing in public domain.

It may be manifested in the form of an invention,

literary or artist work, design of an article, symbol,

distinguishable mark etc., that has imminent or

potential commercial value.

Defining IPR

statutory rights

territorial in nature

provides ‘monopoly’ to the right holders for commercial exploitation

enable ‘holders’ to exclude others from unauthorized use

limited period

provides right to ‘prospect’

require disclosure

General features of IPR Laws

Four Distinct Phases

Up to 1985

Practically no awareness of IPRs

Era of free exchange of resources and technologies

1986 – 1995

International developments: CBD and WTO

(TRIPS)

Obligations for compatible National Laws

Issues regarding access to genetic resources, benefit

sharing, farmers’ rights, traditional knowledge

debated; debates continue

ICAR also involved in inter-departmental/

ministerial meetings and international negotiations

IP Laws and Agriculture Research

1996 - 2005 PPVFR Act (2001); Biological Diversity Act (2002)

1997 ICAR Rules and Guidelines for training,

consultancy services, contract research and contract

service; concept of Intellectual fee and sharing with

institute incorporated

IPR Cell created in ICAR in 1998 and ADG (IPR)

designated, awareness on IP-issues created in general

meetings

One–day workshops from ICAR Hqr and Short Course

on Orientation for PGR Policy & Emerging Intellectual

Property Rights Issues at NBPGR

Patent filling minimal and centralized from ICAR Hqrs

IPR Laws and Agriculture Research

2006 - onwards

WTO Agreement on Trade-Related Intellectual Property

Rights: Provides for minimum standards on IPR protection

Implementation of India’s new IPR Laws

Maximum ICAR Hqr-driven awareness on IP issues

IPR Laws and Agriculture Research

Convention on Biological

Diversity, 1993

Sovereign right of nations:

Conservation, sustainable

utilization and equitable benefit

sharing

Bioresources

Biological Diversity Act

(BDA), 2002 (2004)

Regulates access to all

bioresources

International

Undertaking on

PGR, 1983

Common

heritage of

mankind

International

Treaty on PGRFA,

2004 Facilitated access;

Multilateral system

of use; mutually

agreed terms /

Standard Material

Transfer Agreements

(SMTA)

PGR

Ex-situ collections

Farmers’ Rights

Benefit sharing

Access Product

UPOV

Patent

WTO / TRIPS (1994)

Mandatory requirement

for protection for plant

varieties,

microorganisms

patentable

Protection of Plant Varieties and Farmers’

Rights (PPVFR) Act, 2001 (2005)

IPR Protection to extant and new varieties

Genetic Resources and IPR…

“legal monopoly right granted to an inventor

for an invention in return for the disclosure

of the invention”

Indian Patents Act, 1970

The Patents (Amendment) Act, 1999

The Patents (Amendment) Act, 2002

Fully TRIPs Compliant

The Patents (Amendment) Act, 2005

Patents (Amendment) Rules, 2006

- A new product or process

- Involves an Inventive Step

- Capable of Industrial Application

Sec. 2(j)

exclusive right to inventor for making selling or using invention

Patent

Frivolous or contrary to natural laws

Contrary to public

order and morality • Mere discovery of scientific

principle

• Formulation of an abstract theory

• living things /non living

substances in nature

Non-Patentable

Subject Matter Section 3

Mere discovery of

new form of known

substance-not

resulting in

enhancement of known

efficacy or new

property or new use

Method of horticulture/

agriculture

Composition –mere admixture –

aggregation of properties

arrangement or rearrangement or

duplication of known devices

Process for medical,

surgical, curative,

prophylactic treatment

of human or animal

Plants, animals in whole or part

except micro-organisms

Seeds, varieties species and

Essentially Biological Processes

for production or propagation of

plants and animals

a mathematical or

business method or a

Computer Programs

per se or algorithm

TK or aggregation or

duplication of known

properties of TK

Protection of Plant Varieties and Farmers’

Rights Act

Establishes

• Protection of Plant Varieties and Farmers’ Rights Authority

• Plant Variety Registry

• Plant Varieties Protection Appellate Tribunal

Rights Conferred

to produce, sell, market, distribute, import or export the variety

Total Initial Extended

Trees & Vines 18 from date of registration 9 9

Other Crops 15 from date of registration 6 9

Extant Notified

varieties

15 from date of notification of variety under the Seeds

Act, 1966 by the Central Govt.

New Variety

Extant Variety

Notified under Seeds Act, 1966

Farmers Variety

Variety of Common Knowledge

Essentially Derived Variety

Farmers’ variety means a variety which has

been traditionally cultivated and evolved by

the farmers in their fields, or is a wild

relative or land race of variety about which

the farmers possess the common knowledge

Varieties as per the Act…..

• At filing of application the propagating or harvested material has been sold for : Within India less than one year; Outside India Trees/Vines 6 Years, others 4 years

Novelty

• Distinguishable by at least one essential characteristics from a variety which is a matter of common knowledge

Distinctiveness

• Sufficiently uniform in its essential characteristics Uniformity

• Essential characteristics remain unchanged even after repeated propagation Stability

• Protects of the denomination of variety Denomination

The DUS test…..

Extant: Two location for one crop seasons

New Varieties: Two locations for two crop seasons

EDV: Decided by Authority on case to case basis

Submission of amended application

Notice of Opposition to the Applicant

Countering the opposition (2

months)

PVP Examiner verifies application for completeness

Complete application

Publication Plant Variety Journal of India

Opposition (fees/ 3 + 1 month)

Serving Counter Statement to opposing party

Hearing, if required

Opposition plea rejected Opposition plea upheld

Examination of NDUS

Issue of certificate of registration, Publication and National Registry

notice for

completion

No opposition

Proposal rejected

Fees

Seed

Annual/Renewal fee Compulsory license Benefit sharing Revocation/Surrender

The process…..

Researchers’ Right

a) Conducting experiment or research; or

b) Use as an initial source of variety for the purpose of creating

other varieties: Provided that the authorization of the

breeder of the registered variety is required where the

repeated use of such variety as a parental line is necessary

for commercial production of such other newly developed

variety.

Farmers Rights : Farmers are recognised as

a) Breeder

b) Cultivator/consumer

c) Conserver

PPVFR: Exceptions…….

New varieties and Extant varieties including

Farmers’ varieties are eligible for registration

Entitled to save, use, sow, re-sow, exchange, share

or sell his farm produce including seed of a

variety protected under the Act. Farmer cannot

sell branded seed of a protected variety.

Registered breeder must disclose expected

performance under given conditions; Failure of

expected performance-farmers may claim

compensation

PPVFR: Farmers' Right / Privileges……

Protection of innocent infringement: Right not be

deemed to be infringed by a farmer who at the

time of such infringement was not aware of the

existence of such right.

Disclosure in the application information

regarding the use of genetic material by any tribal

or rural families in the breeding or development

of such varieties.

Communities file in notified center claim for

compensation if such community has contributed

significantly to evolution of registered variety.

Allows compulsory licensing on grounds of

levying unreasonable price to seed

PPVFR: Farmers' Right / Privileges…

• Legal requirements of marketing manufacturing

Monopoly rights prohibiting unauthorized use

• Ensure the safety and quality of products

Reward for original effort

• Compliance mandatory

Voluntary in nature

• Compliance till product is being manufactured/marketed

Fixed period

• Aimed at public health/safety in manufacturing, consumption, usage, fairness in distribution for product, and truthfulness to consumers

Encouraging innovations

• Orientation towards public interest to create deterrents for unscrupulous marketing/ usage

Orientation towards inventors

IPR vs. Regulations

Biological Diversity Act- 2002

• Conservation and sustainable use of biodiversity

• Equitable sharing of benefits arising from use of

GR

Regulated access to bioresources and associated

information

• Non-Indians - National Biodiversity Authority

• Indians - intimation to State Biodiversity Boards

• Involvement of local bodies in decision making

regarding use of biological diversity

• Funds at National, State and Local level for

conservation and benefit sharing

• IPRs with prior approval of NBA

www.nbaindia.org

Exemption: International Collaboration Research Projects between

Institutions including Government sponsored Institutions and such Institutions in other countries

Regulations: Genetic resources

Mutually Agreed Terms (MAT)

• A contractual arrangement, executed on a bilateral basis

• Provides opportunity to providing country to negotiate a share of the benefits derived from the use of the genetic resources

• May specify the permitted or prohibited uses of the genetic resources provided, including whether or not it may be commercialized

Prior Informed Consent (PIC)

• Applicant to provide information concerning the GR required, purpose for which required and any proposal for benefit sharing

• Authority may consult indigenous/local communities/other stakeholders

• Responsible authority of the provider country can grant or refuse access

Genetic Resources and Regulations…

Four Bioresources related Activities

regulated under BD Act

1(a) Research or Bio-survey & Bio-utilization

for research [for persons/entities under Sec. 3(2)] (b) For research or bio-survey & bio-utilization for commercial utilization [for all persons] 2) Transferring results of research on biological

resources to persons/entities u/s 3(2) 3) Seeking IPR over product/process based on research

on any bio-resource [for all persons]

[Breeders’ Rights under PPV&FRA exempted] 4) Third party transfer of accessed bio-resources

[for Sec.3(2) persons/ entities]

Benefit Sharing on Mutually Agreed Terms

A. Commercial Utilization: Benefit sharing component based on annual gross ex-factory

sale of the product Up to Rupees 1,00,00,000 : 0.1 % Up to Rupees 1,00,00,001 up to 3,00,00,000: 0.2 % Above Rupees 3,00,00,000 : 0.5 %

B. Transfer of research results, the benefit sharing obligation:

3.0 to 5.0% of the monetary consideration.

C. Intellectual Property Rights : If applicant himself commercialize the process/product:

0.2 – 1.0% of Annual Ex-factory gross sale (minus govt. taxes)

If applicant assigns / licenses the process / product / innovation to a third party for commercialization:

3.0 – 5.0 % of the up front fee received plus 2.0 – 5.0 % of annual royalty received.

Penalties for Violations

of the Biological Diversity Act

Contravention of sections 3 or 4 or 6:

punishable with imprisonment for a term

which may run up to 5 years, or with fine

which may extend to 10 lakh rupees or

with both [ Section 55 (1)].

Offences under this Act are cognizable

and non-bailable. [Section 58]

Provisions of this Act shall be in addition

to the provisions in any other law relating

to forests or wildlife.

Drivers of innovation centric research ecosystem

Sustainable Institutional

Mechanisms Commensurate Professional

Capabilities

Organizational Policy

Converting

Science

into

Innovation

Reorienting R&D as per new IPR regimes

Engaging in partnerships

Managing Intellectual Assets

Goal clarity and role clarity

Policy Framework

Decentralized three-tier system:

XI Plan Scheme (2007-2012) Institute Technology Management Units (ITMUs)

established in all ICAR institutes as a single-window

mechanism to showcase the intellectual assets of the institute

and pursue matters related to IP management and technology

commercialization.

The Zonal Technology Management Units (ZTMUs)

Formed as the middle-tier, in synergy with the ITMUs in their

respective zones.

Intellectual Property and Technology Management (IP&TM)

Unit at ICAR Hqrs

Facilitation/ monitoring functions and coordination for the

implementation of the XI Plan Scheme

Institutionalizing IP management in ICAR

National Agriculture Innovation Fund (NAIF)

-XII Plan Scheme

Component I- Innovation Fund

Further strengthen institutional mechanism to

protect/manage innovations/ intellectual properties

(IPs) generated as per ICAR’s guidelines

Component-II - Incubation fund

Business Planning and Development Units (NAIP)

Further strengthen and expand the agri-business

incubators’ network and address the critical gaps

observed for successful commercialization of

technologies through business incubation for making

them an attractive proposition to any commercial

entity

IP &Technology Processing Framework

Research

Evaluation

& Prior Art

Search

IP MANAGEMENT STRATEGY

Technology

Scan

IP

Assessment IP Portfolio

Management

Technology

Evaluation /Valuation Patent use,

transfers

Extension

Network

Licensing/

Entrepreneurship

Development

Zonal Units/ ABI

Secure IPR;

Generate IP

status Report

Technology

Landscape;

Gap Analysis

Collaborative Research

Agreement/ MoU

Ownership

In licensing

Technologies

generated in

institute

Technology forecast & future R&D strategy

Agri-Tech Foresight Centre

IP Assets

Identification &

Documentation

Maintain IP

Portfolio

Prosecution

Support

Incubation

Mature for

transfer

IP Audit

Grassroots

innovators Rural

entrepreneurs

Market research

Standard terms

Negotiation

Further R&D

required

Market watch

Handholding

28

Help institutes answer the following question:

• How appropriate technologies are to be created?

• How it can be exploited to serve the stakeholders?

• How to integrate technology with business strategy?

• How to use technology to gain competitive advantage?

• How to improve the flexibility of systems for collaborations and partnerships ?

Your proposal is innovative. Unfortunately we wont be able to use it

because we’ve never tried something like this before

Role of ITMUs

Intellectual Property Portfolio of ICAR

31 55

177

334 349

1971-1985 1986-2000 2001-2005 2006-2010 2011-2015

Patent Filing Over Years

Patent Filing Trend at ICAR Institutes

Efforts by individual scientists

International Development had a role

National initiatives did it

IP Awareness, Appropriate policy/ Guidelines , Funding Support

Intellectual Property Portfolio of ICAR

2389

1032

70 96 74 23

IPRs Filed IPRs Granted Institute Involved No o

f IP

R A

pp

lica

tion

s

IPR Portfolio of ICAR Institutes

Cumulative 2017-18

1045

1219

102 23

215

777

30 10 70

17 17 3 0

200

400

600

800

1000

1200

1400

Patent Application Plant Varieties Trademarks Design

IPR Portfolio at ICAR Institutes

Application Filed Application Granted Institute Participated

Thomson Reuters India Innovation

Awards 2015 - Academic and

Research Institutes

S No Name of ABI Center State

1 NRC Pig, Guwahati Assam

2 NDRI, Karnal Haryana

3 IIHR, Bangalore Karnataka

4 CIFT, Cochin Kerala

5 CPCRI, Kasargod Kerala

6 IISR, Calicut Kerala

7 CIAE, Bhopal Madhya

Pradesh

8 CIFE, Mumbai Maharashtra

9 CIRCOT, Mumbai Maharashtra

10 ICAR RC NEH, Umiam Meghalaya

11 IARI, New Delhi New Delhi

12 CIFA, Bhubaneswar Orissa

13 NRRI, Cuttack Orissa

14 CIPHET, Ludhiana Punjab

15 CPRI, Jalandhar Punjab

16 CIBA, Chennai Tamil Nadu

17 IIMR, Hyderabad Telangana

18 IIOR, Hyderabad Telangana

19 NAARM, Hyderabad Telangana

20 NRC Meat, Hyderabad Telangana

21 ICRISAT, Hyderabad Telangana

22 CARI-Izatnagar Uttar Pradesh

23 IIVR, Varanasi Uttar Pradesh

24 IVRI, Izatnagar Uttar Pradesh

25 NIRJAFT, Kolkata West Bengal

Subject Areas of ABIs:

1. Animal Science: 5

2. Crop Science: 4

3. Agril. Engineering: 4

4. Agril. Education: 2

5. Horticulture: 5

6. Fisheries: 4

7. NRM: 1

Salient Achievement

Entrepreneurs Admitted for

Incubation: 163

Entrepreneurs Graduated: 61

Entrepreneurship Development

Programme (EDP)Organized: 10

Advanced Workshop on IP Management. Organized by TIFAC in

Collaboration with DRDO and ICAR from 12th to 14th January, 2017 at

NASC, New Delhi

Agri-Business Incubation Centres at ICAR

(April-2016 onwards)

Subject Area Entrepreneurs

Agril Engineering 38

Animal Product and Process 16

Crop Production 30

Fisheries 61

Food Processing 86

Jute and Cotton Procesisng 13

26 ICAR Institutes provided 147 technologies/ services

to 244 Entrepreneurs/ Start-ups/ Incubators/ Trainees

in 6 different Subject Areas for Agri-Business

Development.

IPR and Entrepreneurship Development Activities at

ICAR Institutes

Pre-Plan (2000-

07), 160

XIth Plan, 743

XIIth Plan, 1597

0

200

400

600

800

1000

1200

1400

1600

1800

Pre-Plan (2000-07) XIth Plan XIIth Plan

Institutes Indulge in Commercialization Private/ Govt/ NGO Partners

Partnership Developed Technologies Transferred

MoU Between Ri-Bhoi Mihngi Multi

Purpose Co-Operative Society Ltd and

ICAR RC Umaim for seed

multiplication of Megha Turmeric-1

MoU Between Patanjali Institute

and IARI, New Delhi for VAM

Technology

Agril Engineering

, 317, 11%

Animal Science, 291,

10%

Crop Science, 783,

28% Fisheries, 292, 10%

Horticulture, 1038, 37%

NRM, 120, 4%

Partnership Developed by ICAR Institutes

Technology Commercialization at ICAR Institutes

X

10X

103X

106X

1010X

Technology Partnerships Framework

Commonality of Goal (shared vision)

Complementarity of Strength (I need you)

Costs and funding (no free lunch)

Credits, risks and responsibility sharing (we are

partners)

Conflict resolution (we decide)

Encouraging partnerships…..

THANKS

“There are seven sins in the world: wealth without work,

pleasure without conscience, knowledge without character, commerce without morality, science without humanity,

worship without sacrifice, and politics without principle..”