Freedom to Operate (FTO)
A FTO study was conducted for Indian & US jurisdictions on various components including DREB1A, NOS
Promoter, npt II Marker, rd29A Promoter, NOS Terminator.
It was observed from the preliminary FTO study that there is no granted Indian patent on these components
exists till date and hence the research activity is not infringing any patent rights in India.
IMODInclusive Market Oriented Development
Innovate • Grow • Prosper •
Timelines and Cost
R&D
Event
Selection
BRL 1 BRL 2 Introgression
In-House PTTC & Partners
Current Stage
Event Approval
500,000438,667 410,000 206,000205,556
2013/14 2014/152011/12
Translational Research
FTO analysis conducted for Indian and US jurisdictions on various technology
components indicated non-infringement of any patent rights
Product Development Cycle
A
A
B
Homology to Known
allergens, toxins,
anti-nutrients
Blast Searches
Heat
Stability
Acute Oral Toxicity in
Rats/Mice
(14 Days)
Pepsin
Digestibility
Inheritance Over Multiple
Generations
RT-PCR, Southern, qPCR
data available as above
Western & ELISA to be
performed with Ab (A)
produced from the protein
Pedigree Map
Documentation from
the data recorded
from T1 to T5
Sequence data of
inserted genetic
material & of the
flanking regions
Identification
of ORFs
Genome
Walking
Organisation of
inserted genetic
material
PCR &
Sequencing
Net House
Evaluation
Field trials
Season 1
Field trials
Season 2
Exp. Level of
Protein
ELISA
Reproductive &
Survival Biology
Phenotyping
Site 1
Site 2
Site 3
Site 1
Site 2
Site 3
Composition
al Analysis
Impact on
Non-Target
Org.– Tier 1
Impact on
Non-Target
Org – Tier 2
Livestock
Feeding
Studies
Number of
Insertion Sites
qPCR data
available as
above
Antibody
Production
Protein Equivalence Study
Functional, Structural and
Biochemical Equivalence
Plant Protein
purification
Purification & scale
up of protein from
Bacterial / other
systems
PCR, Southern,
qPCR, RT-PCR
PCR, Southern,
qPCR, RT-PCR
PCR, Southern,
qPCR, RT-PCR
PCR, Southern,
qPCR, RT-PCR
PCR, Southern,
qPCR, RT-PCR
Transformation T0 T1 T2 T3 T5T4 B
Construct
preparation
R&DEventSelectionBRL-I
BRL-
II
Sub-Chronic Feeding
Study in Rodents
(90 Days)
Molecular Studies Field Studies
Protein Studies
Field trials
Gene Flow
Aggressiveness
& Weediness
LOD 0.01%
Strictly Confidential
A
A
B
Homology to Known
allergens, toxins,
anti-nutrients
Blast Searches
Heat
Stability
Acute Oral Toxicity in
Rats/Mice
(14 Days)
Pepsin
Digestibility
Inheritance Over Multiple
Generations
RT-PCR, Southern, qPCR
data available as above
Western & ELISA to be
performed with Ab (A)
produced from the protein
Pedigree Map
Documentation from
the data recorded
from T1 to T5
Sequence data of
inserted genetic
material & of the
flanking regions
Identification
of ORFs
Genome
Walking
Organisation of
inserted genetic
material
PCR &
Sequencing
Net House
Evaluation
Field trials
Season 1
Field trials
Season 2
Exp. Level of
Protein
ELISA
Reproductive &
Survival Biology
Phenotyping
Site 1
Site 2
Site 3
Site 1
Site 2
Site 3
Site 1
Site 2
Site 3
Site 1
Site 2
Site 3
Composition
al Analysis
Impact on
Non-Target
Org.– Tier 1
Impact on
Non-Target
Org – Tier 2
Livestock
Feeding
Studies
Number of
Insertion Sites
qPCR data
available as
above
Antibody
Production
Protein Equivalence Study
Functional, Structural and
Biochemical Equivalence
Plant Protein
purification
Purification & scale
up of protein from
Bacterial / other
systems
PCR, Southern,
qPCR, RT-PCR
PCR, Southern,
qPCR, RT-PCR
PCR, Southern,
qPCR, RT-PCR
PCR, Southern,
qPCR, RT-PCR
PCR, Southern,
qPCR, RT-PCR
Transformation T0 T1 T2 T3 T5T4 B
Construct
preparation
R&DEventSelectionBRL-I
BRL-
II
Sub-Chronic Feeding
Study in Rodents
(90 Days)
Molecular Studies Field Studies
Protein Studies
Field trials
Gene Flow
Aggressiveness
& Weediness
LOD 0.01%
Strictly Confidential
Transgenic Groundnut for Drought Tolerance
Roadmap for Product Development
A model depicting product
development and dissemination
following the regulatory approval
for the selected event(s)
PTTC
ICRISAT
NARS / SAUs
KVKs / ARS
State Seed
Corporation
Farmers
Non-Market Market
Technology
Provider
Product
Development &
regulatory
approvals
Varietal
Development &
Seed Production
Product
Dissemination
PTTC
ICRISAT
NARS / SAUs
KVKs / ARS
State Seed
Corporation
Farmers
Non-Market Market
PTTC
ICRISAT
NARS / SAUs
KVKs / ARS
State Seed
Corporation
Farmers
Non-Market Market
Technology
Provider
Product
Development &
regulatory
approvals
Varietal
Development &
Seed Production
Product
Dissemination
Preliminary Biosafety Data
Bioinformatics studies for potential
allergenicity indicated absence of any
homology of recombinant protein with
known toxin / allergen
Overview
Drought
SignalTransduction
Transcription/Translation
PromoterAPromoterA
PromoterBPromoterB
PromoterCPromoterC
PromoterDPromoterD
SignalPerceptionSignalPerception
GeneAGeneA
GeneBGeneB
GeneCGeneC
GeneDGeneD
DRE
PlantCell
GeneExpression
Stressresponse&tolerance
RegulatoryProtein
(TranscriptionalActivator)
DREB1ADREB1Ard29A-Prd29A-P
Drought
SignalTransduction
Transcription/Translation
PromoterAPromoterA
PromoterBPromoterB
PromoterCPromoterC
PromoterDPromoterD
SignalPerceptionSignalPerception
PromoterAPromoterA
PromoterBPromoterB
PromoterCPromoterC
PromoterDPromoterD
SignalPerceptionSignalPerception
GeneAGeneA
GeneBGeneB
GeneCGeneC
GeneDGeneD
GeneAGeneA
GeneBGeneB
GeneCGeneC
GeneDGeneD
DRE
PlantCell
GeneExpression
Stressresponse&tolerance
RegulatoryProtein
(TranscriptionalActivator)
DREB1ADREB1Ard29A-Prd29A-P
Improved
drought
tolerance
• Improved seed and pod yield
(upto 26%)
• Higher root dry weight and
root length density at deeper
soil (40-90cm)
• Improved drought tolerance
indices (higher relative harvest
index (RHI) and yield reduction
under drought stress)
Sep 2011