WIPO Training of Trainers Program on
Intellectual Property Asset Management
by Biotech SMES
IP Policies and Systems in Public Funded
Biotech R&D Sector
RK Gupta, Head,
Intellectual Property Management Division
Council of Scientific & Industrial Research
New Delhi, India
guptark04@yahoo.com
Evolution of IP Policy of
Scientific Research Institutions of
India
1995-2010
Scientific and Industrial Research
Institutions
Mandate

Research
 Teaching
 Focus on select areas to meet national economic & strategic
requirements
IMPACT of R&D Output
(Patents/Publications)










Capacity building
Alternate process/ products development
Development of technology in case of denials
Control of price of competing products
Employment generation
Growth of New businesses
Revenue generation
Benefit sharing
Development of industrial clusters around R&D institutes
Technology Transfer/ spill-overs
Initial Objectives of IP Policies of Scientific and
Industrial Research Institutions

To create massive awareness programs among
scientists, students and faculty
 To capture IP from ongoing R&D projects
 To identify new problems
 To protect R&D output through appropriate IP
protection nationally and internationally
Objectives of IP Policies of Scientific and
Industrial Research Institutions













CSIR-1996
ICMR-2002
ICAR-2006
To create IPR awareness
To work for societal benefit
To safeguard public health
To facilitate capture and protection of IP at early stages before publication
of research results, where applicable
To facilitate recordal of lab data
To obtain “Invention Disclosures” form from scientists
To form linkages between IP cells of labs and central IP departments
To handle IP ownership issues
To valorise IP through various mechanisms
To facilitate sharing of royalties with scientists
Focus of IP Protection in Scientific
and Industrial Institutions

Patents
 Copyrights
*****
***

Plant varieties

Layout design for integrated circuits

Trademarks

Industrial design

Geographical indication
****
*
*
**
*
Ownership of IP

Scientific departments
 Scientists
 Funding agencies
 Sponsors
 Collaborators (Indian as well as foreign research
institutions/universities)
 Governmental authorities (like NBA)
 IP in contracts, PPPs & International Agreements
 Governmental rights
Valorisation of IP
 Licensing
(exclusive, non-exclusive,
limited exclusive, royalty free, equity)
 Assignment / sale
 Spin-offs and start ups
 Co-Development
Benefit sharing

Scientific Departments
 Researchers
 Technical staff
 Technology Transfer Cells
IP Policies of Scientific & Industrial Research
Institutions-Current Status
IP Policy Components
Remarks
Vision/Mission
stated
Implementing authority
centralized/decentralized/hybrid
Ownership of various firms of IP
need for a flexible policy
Use of significant resources of the institutions
not clear in many cases
Assessment of IP
need for improvement
Invention Disclosure and assignment of rights
existing
Protection of IP in Foreign Countries
need for a dynamic policy
Maintenance of IP rights
need for a better understanding
Material Transfer Agreement
better understanding needed/application of NBA/BDA
Rules
Sharing of Earnings
provisions existing, implementation difficult in several
cases
Conflict of interest
need for better understanding
Publication Policy
clear
Setting up of IP cells
established/need for further strengthening
Issues














Cost of IP protection
Societal concerns
Managing IP in sponsored research/collaborations
Problems in sharing IP in International collaborations
Monitoring and Implementation of IP in agreements
Absence of linkages between IP and development policies
IP valuation and licensing
Formation of Spin-off and Start up companies
IP in acquisition and mergers.
Biological Material Transfer Issues and National legislations
IP enforcement issues
Open source initiatives with global partnerships
Worldwide technology transfer Centers being unprofitable
FTO
IP Management Policy of CSIR
& its Implementation – A Case
Study
Council of Scientific & Industrial Research, India
CSIR

The largest network of publicly funded Research
Labs in the world
 17000 highly qualified Scientists, Engineers,
Auxiliary staff
 Annual Budget about Rupees 1450 Crores aprox.
 R&D in Aerospace, Biological Sciences,
Chemicals, Pharmaceuticals, Drugs, Earth
Resources, Food, construction, minerals, metals,
environment, leather, information products etc.
Council of Scientific & Industrial Research, India
CSIR Mission
“To provide scientific industrial R&D
that maximizes the economic,
environmental & societal benefits for
the people of India”
Serve the Nation
IP Management in CSIR - Genesis
Patenting activity in CSIR - instituted since its very inception
and looked after by its Patent Cell at CSIR HQ. (few patent
filings)
Enactment of Patents Act, 1970 - the Patent Cell upgraded to the
Patents Unit. (Sporadic filings)
India joins WTO in 1995 – the Patents Unit upgraded as a
Division named Intellectual Property Management Division
(IPMD) in 1995
Post -1995 : Boost to patenting of drugs, pharmaceuticals and
bio-tech inventions
CSIR’s IP Policy (1996) : Meeting Post-WTO
Challenges
Statement of the IP Policy
“The maximization of the benefits to CSIR from its
intellectual property by stimulating higher levels of
innovation through a judicious system of rewards,
ensuring timely and effective legal protection for its
IP and leveraging and forging strategies alliances for
enhancing the value of its IP.”
CSIR Targets (Vision 2001)
Portfolio of 500 foreign patents (then 80 in 1996)
Portfolio of 1000 Indian patents (then 436 in 1996)
Meeting post WTO challenges
Goals of the IP Policy
 stimulate and encourage increased creativity and innovation in CSIR
to gain economic advantage;
 develop skills amongst the scientists to understand, interpret and
analyze the techno-legal and business information contained in
patents and other IP documents;
 use the information acquired from analysis of IP documents to direct
and mount strategic R&D programmes;
 establish a globally acceptable system of recording and
documentation of experimental results and data;
 evolve appropriate systems to capture and assess the intellectual
property generated in the CSI R system;
 provide the highest level of professional techno-legal services for
securing and protecting the IP generated;
 manage the portfolio of IP as a business activity;
 manipu1ate the patent portfolio, defensively / and aggressively, to
forge strategic alliances / international S&T collaborations, to gain
business advantage / and ward of competition;
Institutionalization of IP Management
Structure in CSIR
DG, CSIR
IP
management
structure
in CSIR
CSIR LABS
IPMD
Slogan

1996~Patent and publish

1998~Patent, publish and prosper
Capacity Building (1995-2010)

IP Management
 Information & Documentation
 Patent Search & Analysis
 Techno-Legal Drafting
 Patent Litigation
 Licensing, Valuation and negotiating
IP licensing deals
Patent Portfolio Development

Expansion of Patent Coverage
(Improvement Patents)

Protection of New Uses/Combinations

Creation of Buffer Zone Surrounding
Patents
Performance of CSIR
CSIR Patent filing
1000
921
915
900
761
800
719
669
663
700
605
600
500
400
300
377
409
413
421
405
415
407
404
262
170
200
261
207
183
100
0
1999-00
2000-01
2001-02
2002-03 2003-04
India
2004-05 2005-06
Foreign
2006-07
2007-08 2008-09
CSIR Patents Granted Abroad
364
400
339
350
300
300
319
244
218
250
191
200
150
100
94
62
50
0
2000- 2001- 2002- 2003- 2004- 2005- 2006- 2007- 200801
02
03
04
05
06
07
08
09
CSIR Patents Granted in India
800
700
703
600
500
400
341
300
276
200
100
399
112
117
162
278
281
175
0
1999- 2000- 2001- 2002- 2003- 2004- 2005- 2006- 2007- 200800
01
02
03
04
05
06
07
08
09
CSIR Patent Applications filed in foreign countries
1000
900
800
700
600
500
400
300
200
100
0
921
915
605
262
663
669
719
Deliberate intervention to
focus on commercially
and strategically
important inventions
761
404
261
1999- 2000- 2001- 2002- 2003- 2004- 2005- 2006- 2007- 200800
01
02
03
04
05
06
07
08
09
CSIR Patent Applications filed in India
450
400
350
300
250
200
150
100
50
0
377
409
413
421
Deliberate intervention to
focus on commercially
and strategically
important inventions
405
415
407
207
170
183
1999- 2000- 2001- 2002- 2003- 2004- 2005- 2006- 2007- 200800
01
02
03
04
05
06
07
08
09
US Patents Granted
(till April 6, 2010)
1 CSIR
1103
2 IITs
25
3 IISc
08
4 Other Indian Universities
22
Sources : USPTO
PCT Applications Published during 2002-2009
Sr.
No.
Organizations
2002
2003
2003
2004
2004
2005
2005
2006
2006
2007
2007
2008
2008
2009
Total
Avera
ge
181
235
278
268
221
260
253
1696
242
1
CNRS, France
2
CSIR, India
73
139
173
158
95
91
49
778
111
3
RIKEN, Japan
32
87
108
78
88
74
55
522
75
4
CSIRO, Australia
68
39
64
47
45
64
55
382
55
5
CSIR, South
Africa
4
8
3
8
5
11
5
44
6
6
Max Planck,
Germany
60
62
55
59
55
55
54
400
57
Some key portfolios







Bio-enhancers
Standardized Herbal Formulations
Anti-malarials and anti-cancer
compounds and formulations
Anti-diabetic molecules
Anti-oxidants
Hepatoprotectives
Immunomodulators
Some key portfolios






Chemicals and Polymers
Leather
Bio-informatics Products
Nanotechnology
Food products and processes
Engineering
Portfolio Building – An Example
Extract / Active Betel Leaf Fraction
P
Antiasthamatic Activity
P
Antimonocytic Activity
P
Antileishmanial Activity
P
Immunomodulator Activity
P
Anti Leukemia Activity
Market Entry
NEW
SYNERGIS
TIC
FORMULA
TION
Compounds Identified
New Use Protected
FORMULATION
+ COMPOSITION
Models for Valorizaion of IP







Creating a Market Share in an established market
Licensing and R&D Collaboration
Breaking the monopoly of Multinationals
Solving Basic Problems of the Poor
Strategic and Public health
Attracting Contract research
Creating new opportunities through Image and
Confidence Building
Major IP Licensing Deal - I

IMTECH’s Clot specific Streptokinase
Technology Licensed to NOSTRUM
Pharmaceuticals nc., USA in July, 2006

More than Rs 28 Crores –milestone payments

Royalties
Success Stories in Licensing - II






NCL-GE Alliance – originated in 1993.
GE supported the R&D at NCL
Alliance operating for over 9 years successfully
and emerged as a paradigm in “relationship”
management in R&D.
Cash flow to NCL from GE of around USD 8.5 m
over the period 1994-1995 to 2003-2004
Exposure to and training of NCL scientists to
world class R&D management practices.
Building up of world class facilities and resources
in NCL
Success Stories in Licensing - II






Attracting and hiring of talented young scientists
New contract research opportunities with
multinational companies
Diffusion of ideas and generic methods developed
to Indian industries
Half a dozen patents assigned to GE
CSIR owns several patents based on generic ideas
developed while interacting with GE having
relevance to systems other than polycarbonates
Led to Setting up of GE’s R&D Centre at
Bangalore
Success Stories in Licensing - III
United States Patent 6,893,479 (CSMCRI)
Integrated method for production of carrageenan and
liquid fertilizer from fresh seaweeds
“An integrated method is developed to utilize to a maximum extent the
fresh biomass of seaweeds such as Kappaphycus alvarezii that can be
crushed to release sap and where the sap is useful as a potent liquid
fertilizer after suitable treatment with additives and dilution while the
residue is a superior raw material for extraction of κ-carrageenan, thereby
enhancing the value of the seaweed. Other advantages of the invention
include a reduced drying time and drying area to obtain the raw material
for κ-carrageenan production in dry and storable form, a reduced cost of
transporting and storing this raw material because of its lesser bulk, easier
handling due to its free flowing granular nature, and its direct use for gel
preparation in certain applications”
© Council of Scientific & Industrial Research, India
Success Stories in Licensing - IV

CSIR licenses Sea Weed Technology to Pepsico

A plant growth harmone and regulator is derived
from fresh Sea Weed grown along the shoreline.

Liquid Sea Weed Fertilizer increases yields from
same seed by 10% for wheat, 30% for peddy, 2030% for fruits and vegetables to 35% for corn and
chana, BT cotton 20%, Banana for 19%.

Patent application fined in India and abroad
© Council of Scientific & Industrial Research, India
Case Study-V

Licensing of IICT’s anti-cancer patent
portfolio to a US Biopharmaceutical Co

Returns: Rs. 2.5 Crores (subject to
milestones) +royalties
Attracting Multinational Contract
Research
CSIR’s Licensed Patents
% Utilization of unique patents in force
8.67
% Utilization of patent applications under prosecution
2.60
Current & Future IP Strategy

To plan and design strategic patent portfolios for short, medium and
long term development requirement of national economy

To partner with national and international players to develop strategic
IP portfolios for national economic needs

To focus on commercially and strategically important inventions

Valorization of existing IP Portfolios

Formation of a separate entity for licensing / spin-offs etc.
Challenges


Implementation of Bill on Protection and
Utilization of Publicly Funded Research
Need for a harmonized National IP Policy
Framework with basic common
components
THANKS