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IP Policies and Systems in Public Funded Biotech R&D Sector

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Presentation on theme: "IP Policies and Systems in Public Funded Biotech R&D Sector"— Presentation transcript:

1 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

2 Evolution of IP Policy of Scientific Research Institutions of India

3 Scientific and Industrial Research Institutions
Mandate Research Teaching Focus on select areas to meet national economic & strategic requirements

4 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

5 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

6 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

7 Focus of IP Protection in Scientific and Industrial Institutions
Patents * * * * * Copyrights * * * Plant varieties * * * * Layout design for integrated circuits * Trademarks * Industrial design * * Geographical indication *

8 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

9 Valorisation of IP Licensing (exclusive, non-exclusive, limited exclusive, royalty free, equity) Assignment / sale Spin-offs and start ups Co-Development

10 Benefit sharing Scientific Departments Researchers Technical staff
Technology Transfer Cells

11 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

12 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

13 IP Management Policy of CSIR & its Implementation – A Case Study
Council of Scientific & Industrial Research, India

14 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

15 CSIR Mission Serve the Nation
“To provide scientific industrial R&D that maximizes the economic, environmental & societal benefits for the people of India” Serve the Nation

16 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, 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 : Boost to patenting of drugs, pharmaceuticals and bio-tech inventions

17 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)

18 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;

19 Institutionalization of IP Management Structure in CSIR
DG, CSIR IP management structure in CSIR CSIR LABS IPMD

20 Slogan 1996~Patent and publish 1998~Patent, publish and prosper

21 Capacity Building ( ) IP Management Information & Documentation Patent Search & Analysis Techno-Legal Drafting Patent Litigation Licensing, Valuation and negotiating IP licensing deals

22 Patent Portfolio Development
Expansion of Patent Coverage (Improvement Patents) Protection of New Uses/Combinations Creation of Buffer Zone Surrounding Patents

23 Performance of CSIR

24 CSIR Patent filing

25

26

27 Deliberate intervention to focus on commercially and strategically important inventions

28 Deliberate intervention to focus on commercially and strategically important inventions

29 US Patents Granted (till April 6, 2010) 1 CSIR 1103 2 IITs 25 3 IISc
08 4 Other Indian Universities 22 Sources : USPTO

30 PCT Applications Published during 2002-2009
Sr. No. Organizations Total 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 45 382 5 CSIR, South Africa 8 11 44 6 Max Planck, Germany 60 62 59 54 400 57

31 Some key portfolios Bio-enhancers Standardized Herbal Formulations Anti-malarials and anti-cancer compounds and formulations Anti-diabetic molecules Anti-oxidants Hepatoprotectives Immunomodulators

32 Some key portfolios Chemicals and Polymers Leather
Bio-informatics Products Nanotechnology Food products and processes Engineering

33 Portfolio Building – An Example
Extract / Active Betel Leaf Fraction P NEW SYNERGISTIC FORMULATION Antiasthamatic Activity P Antimonocytic Activity Compounds Identified P Antileishmanial Activity P New Use Protected Immunomodulator Activity P FORMULATION + COMPOSITION Anti Leukemia Activity Market Entry

34 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

35 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

36 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 to Exposure to and training of NCL scientists to world class R&D management practices. Building up of world class facilities and resources in NCL

37 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

38 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

39 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, 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

40 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

41 Attracting Multinational Contract Research

42 CSIR’s Licensed Patents
% Utilization of unique patents in force 8.67 % Utilization of patent applications under prosecution 2.60

43 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.

44 Challenges Implementation of Bill on Protection and Utilization of Publicly Funded Research Need for a harmonized National IP Policy Framework with basic common components

45 THANKS


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