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RK Gupta, Head,
Intellectual Property Management Division
Council of Scientific & Industrial Research
New Delhi, India
IP Policies and Systems in Public Funded Biotech R&D Sector
WIPO Training of Trainers Program on Intellectual Property Asset Management
by Biotech SMES
Evolution of IP Policy of Evolution of IP Policy of Scientific Research Institutions of Scientific Research Institutions of
IndiaIndia
1995-20101995-2010
Scientific and Industrial Research Scientific and Industrial Research InstitutionsInstitutions
Mandate
Research Teaching Focus on select areas to meet national economic & strategic
requirements
IMPACT of R&D Output IMPACT of R&D Output (Patents/Publications)(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 Initial Objectives of IP Policies of Scientific and Industrial Research InstitutionsIndustrial 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 Objectives of IP Policies of Scientific and Industrial Research InstitutionsIndustrial 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 Focus of IP Protection in Scientific and Industrial Institutionsand Industrial Institutions
Patents * * * * * Copyrights * * * Plant varieties * * * * Layout design for integrated circuits *
Trademarks * Industrial design * * Geographical indication *
Ownership of IPOwnership 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 IPValorisation of IP
Licensing (exclusive, non-exclusive, limited exclusive, royalty free, equity)
Assignment / saleSpin-offs and start upsCo-Development
Benefit sharingBenefit sharing
Scientific DepartmentsResearchersTechnical staffTechnology Transfer Cells
IP Policies of Scientific & Industrial Research IP Policies of Scientific & Industrial Research Institutions-Current StatusInstitutions-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
IssuesIssues 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 IP Management Policy of CSIR & its Implementation – A Case & its Implementation – A Case
StudyStudy
Council of Scientific & Industrial Research, India
CSIRCSIR 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 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 - GenesisIP 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 CSIR’s IP Policy (1996) : Meeting Post-WTO ChallengesChallenges
“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.”
Statement of the IP Policy
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 challengesMeeting 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 Institutionalization of IP Management Structure in CSIRStructure in CSIR
DG, CSIR
CSIR LABS IPMD
IP management
structure in CSIR
SloganSlogan
1996~Patent and publish
1998~Patent, publish and prosper
IP ManagementInformation & DocumentationPatent Search & AnalysisTechno-Legal DraftingPatent LitigationLicensing, Valuation and
negotiating IP licensing deals
Capacity Building (1995-2010)Capacity Building (1995-2010)
Patent Portfolio DevelopmentPatent Portfolio Development
Expansion of Patent Coverage
(Improvement Patents)
Protection of New Uses/Combinations
Creation of Buffer Zone Surrounding Patents
Performance of CSIRPerformance of CSIR
CSIR Patent filingCSIR Patent filingCSIR Patent filingCSIR Patent filing
377409 413 421 405 415 407
170207 183
262
605663
915
669719
921
761
261
404
0
100
200
300
400
500
600
700
800
900
1000
1999-00 2000-01 2001-02 2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09
India Foreign
CSIR Patents Granted Abroad
6294
191218
300
244
364339
319
0
50
100
150
200
250
300
350
400
2000-01
2001-02
2002-03
2003-04
2004-05
2005-06
2006-07
2007-08
2008-09
CSIR Patents Granted in India
112 117
341
162
276
175
278 281
399
703
0
100
200
300
400
500
600
700
800
1999-00
2000-01
2001-02
2002-03
2003-04
2004-05
2005-06
2006-07
2007-08
2008-09
CSIR Patent Applications filed in foreign countries
262
605663
915
669719
921
761
261
404
0100200300400500600700800900
1000
1999-00
2000-01
2001-02
2002-03
2003-04
2004-05
2005-06
2006-07
2007-08
2008-09
Deliberate intervention to focus on commercially and strategically important inventions
CSIR Patent Applications filed in India
377409 413 421 405 415 407
170207
183
050
100150200
250300350
400450
1999-00
2000-01
2001-02
2002-03
2003-04
2004-05
2005-06
2006-07
2007-08
2008-09
Deliberate intervention to focus on commercially and strategically important inventions
US Patents Granted (till April 6, 2010)
1 CSIR 1103
2 IITs 25
3 IISc 08
4 Other Indian Universities 22
Sources : USPTOSources : USPTO
PCT Applications Published during 2002-2009PCT Applications Published during 2002-2009
Sr. No.
Organizations2002
-2003
2003-
2004
2004-
2005
2005-
2006
2006-
2007
2007-
2008
2008-
2009Total
Average
1 CNRS, France 181 235 278 268 221 260 253 1696 242
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
5CSIR, South Africa
4 8 3 8 5 11 5 44 6
6Max Planck, Germany
60 62 55 59 55 55 54 400 57
Some key portfoliosSome key portfolios
Bio-enhancers Standardized Herbal Formulations Anti-malarials and anti-cancer
compounds and formulations Anti-diabetic molecules Anti-oxidants Hepatoprotectives Immunomodulators
Chemicals and Polymers Leather Bio-informatics Products Nanotechnology Food products and processes Engineering
Some key portfoliosSome key portfolios
Portfolio Building – An ExamplePortfolio Building – An Example
Extract / Active Betel Leaf Fraction
Antimonocytic Activity
Antileishmanial Activity
Immunomodulator Activity
Anti Leukemia Activity
P
P
P
P
Market Entry
NEW SYNERGISTIC FORMULATION
Compounds Identified
New Use Protected
FORMULATION + COMPOSITION
Antiasthamatic Activity
P
Models for Valorizaion of IPModels 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 - IMajor 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 - IISuccess 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 - IISuccess 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 - IIISuccess 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 - IVSuccess 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, 20-30% 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-VCase 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 Attracting Multinational Contract ResearchResearch
CSIR’s Licensed PatentsCSIR’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 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