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..”