www.bcil.nic.in

1. NATIONAL EXPERIENCES IN TRANSFER OF BIOTECHNOLOGIES PRESENTATION BY: DR. PURNIMA SHARMA MANAGING DIRECTOR BIOTECH CONSORTIUM INDIA LIMITED NEW DELHI, INDIA AUGUST 18, 2008 www.bcil.nic.in

2. TRENDS: BIOTECHNOLOGY TRANSFER IN INDIA • New Technology Application (Increase in research investment) • Global Technology In-licencing/JVs • Public Private Partnership for technology development and up-gradation (Increased Private R&D funding ) www.bcil.nic.in

3. BIOTECHNOLOGY TRANSFER IN INDIA: UNIQUE ADVANTAGES • HIGH QUALITY HUMAN RESOURCES • GOVERNMENT SUPPORT AT HIGHEST LEVEL • STRONG INTELLECTUAL PROPERTY (IP) PROTECTION SYSTEM www.bcil.nic.in

4. BIOTECHNOLOGY TRANSFER IN INDIA: HUMAN RESOURCES • ‘The Land of Ideas’ – Dr. R.A. Mashelkar, Former, DG,CSIR • 3,00,000 biotech, bioinformatics and biological science graduates annually • NRIs leading biotech research • Reverse Brain Drain • 40% increased in outsourced contract research www.bcil.nic.in

5. BIOTECHNOLOGY TRANSFER IN INDIA: STRONG GOVERNMENT SUPPORT • Biotech is Government’s priority • Technology transfer legislation (Bayh-Dole India) • New Government schemes to catalyze technology transfers (Funds/infrastructure) • Biotechnology Industry Research Assistance Council (BIRAC) for monitoring, supporting and nurturing R&D in small and medium biotechnology companies www.bcil.nic.in

6. BIOTECHNOLOGY TRANSFER IN INDIA: STRONG IP PROTECTION SYSTEM AMENDMENTS IN INDIAN PATENT ACT,1970 • Patent Validity 20 Years from the date of filing • Product Patents • Life forms except Microorganisms, not patentable • Protection of plant varieties • In case of infringements and litigation on process patents, burden of proof of non-infringement to rest with the defendant. www.bcil.nic.in

7. MODELS FOR TECHNOLOGY TRANSFER • University Model • Public Private Partnership Model • Technology Incubators • Specialized Technology Transfer Agencies (BCIL) www.bcil.nic.in

8. University Model University/Scientist concerned Industry • Involves direct interaction between- Scientist and Industry • Technology reaches Industry by • Publications made by Scientist • Patents filed • Presentation in Conference www.bcil.nic.in

9. Public Private Partnership (PPP) Promotion Schemes • Grant in aid & soft loans to industry for development, scale up & commercialization of innovative technologies developed in house/ public laboratories • SBIRI (SMALL BUSINESS INNOVATION RESEARCH INITIATIVE)(Aims at promoting R&D in SME’s and to provide enabling mechanism to build in-house company technology capabilities) • TDB (TECHNOLOGY DEVELOPMENT BOARD) - NMITLI (NEW MILLENNIUM INDIAN TECHNOLOGY LEADERSHIP INITIATIVE) www.bcil.nic.in

10. Idea Incubation Development Finance Growth Capital Pre-seed funds 1 – 5 crores Seed and early-stage finance 5 – 20 crores Traditional finance > 20 crores Funding options based on Life Cycle Systematic Intervention Required Mature Financial Market TDB, Venture Capital NMITLI, SBIRI PRDSF, TDDP SBIRI

11. BIOTECH INCUBATORS • MODULAR LABORATORIES • COMMON FACILITIES - Specialized facilities (tissue culture, fermentation, downstream processing, phytochemical extraction, r-DNA work) - Analytical testing/animal testing laboratory/animal house - Common effluent treatment plant - Bonded warehouse - Utilities SPECIALIZED INFRASTRUCTURE FOR TECHNOLOGY REFINEMENT AND SCALEUP AT AFFORDABLE COST Contd.

12. BIOTECH INCUBATORS • MODULAR LABORATORIES • COMMON FACILITIES - Specialized facilities (tissue culture, fermentation, downstream processing, phytochemical extraction, r-DNA work) - Analytical testing/animal testing laboratory/animal house - Common effluent treatment plant - Bonded warehouse - Utilities SPECIALIZED INFRASTRUCTURE FOR TECHNOLOGY REFINEMENT AND SCALEUP AT AFFORDABLE COST Contd.

13. Biotech Incubators • Platforms to meld the latest in research innovation with the market place • Provides facilities to turn ideas into a commercial reality • Advantages: • Permit company founders to conserve cash • Accelerate the commercialization of technology • Provides shared but secure laboratory facilities • Help to shift the startup's culture from an academic perspective to an entrepreneurial one www.bcil.nic.in

14. Biotech Consortium India Ltd. (BCIL): A nodal agency for facilitating Commercialization of Biotechnology networking among Govt., Industry, Academia and other stakeholders Incorporated : 1990 Promoter : Department of Biotechnology, Government of India Shareholders : All India Financial Institutions Authorized Capital Issued, Subscribedand Paid Up Capital : US$ 2.3 million : US$ 1.3 million Project Management Consultancy Technology Transfer Certification Services Biosafety Information Services Human Resource Development Patent Facilitation www.bcil.nic.in

15. BIOTECH CONSORTIUM INDIA • Key Strengths… • BCIL is the primary organization in India promoting networking activities between stakeholders in the biotechnology, Industry and academia • BCIL has expertise in facilitating IPR protection , regulatory approvals etc. • BCIL provides trained human resources to companies • BCIL has trained more than 1000 candidates in the last 7 years under its Biotechnology Industry Training Program in areas of R&D, marketing, production, quality control, patent processing, general management and bioinformatics

16. MODEL ADOPTED BY BCIL Technology Identification • Scouting for patents, invention disclosures etc. • Assessment and follow up of potential ongoing projects • Assessment of technology based on its scientific and commercial viability • Evaluation of market for the technology • Assessment of novelty and IPR related issues • Packaging of the technology for transfer TechnologyEvaluation & Packaging Licensee Selection and Pricing • Identification of prospective licensees based on their technical capability, financial resources and area of expertise • Determination of pricing based on product development costs, market demand, growth potential, IPR status etc. Contd. www.bcil.nic.in

17. MODEL ADOPTED BY BCIL Technology Transfer Agreements • Memorandum of understanding • Confidentiality agreements • Material transfer agreements • R&D contracts • Fee Components: Lump Sum + Royality • Transfer of the technical know-how Technology Transfer Monitoring and Consultancy • To facilitate Demonstration • Monitoring- Review meetings • Consultancy • Fund Syndication www.bcil.nic.in

18. Keeping Academia & Industry motivated for expeditious Technology development & commercialization • Large scale awareness of the technology • Timely Marketing of the technology nationally/ internationally to suitable clients • Expeditious Technology evaluation and transfer • Recognition to the Inventor/Institute through good realization of tech transfer • Continuous monitoring • Timely troubleshooting • Assistance in marketing/market development • Timely Protection of Intellectual Properties www.bcil.nic.in

19. TECHNOLOGY TRANSFER AT BCIL Technologies Transferred Contd. www.bcil.nic.in

20. TECHNOLOGY TRANSFER AT BCIL Technologies Transferred Contd. www.bcil.nic.in

21. TECHNOLOGY TRANSFER AT BCIL Technologies Transferred www.bcil.nic.in

22. TECHNOLOGY TRANSFER AT BCIL Technologies Available for Transfer 1. Production of highly thermostable, recombinant enzyme Superoxide Dismutase (US Patent No. 6485950) 2. Process for the development of a series of cloning vectors to facilitate genetic manipulation of Amycolatopsis species (US Patent No. 5,985,560) 3. Process for production of recombinant anti HIV-1 glycoprotein Epap-1 targeting gp 120 region of the virus (Patent Application No. PCT/IN2006/000204) 4. Sensitive rapid diagnostic test of human papilloma virus (HPV) 5. Eucalyptus plant extract based biopesticide formulation ‘Bollcure’ effective against cotton bollworm Helicoverpa armigera 6. New antibacterial compound “Oenostacin” isolated from the roots of Oenothera biennis, with activity against fluroquinolone resistant bacteria and process for its chemical synthesis (US Patent No.6,365,197) 7. Method of controlling gene expression in all cells of plants including vascular bundles via a promoter derived from Rice tungro bacilliform virus (Application No. PCT/IN2005/000285) 8. Recombinant chimeric antigen as a vaccine candidate against Brucellosis 9. Nerve calming anti-depressant cream from Saliva sclarea and other natural products 10. Two novel molecules identified from Lichens having a broad spectrum antimicrobial activity www.bcil.nic.in

23. Changing Tech Transfer Scenario • Patent Status • Scale of Tech. Development and Validation • Freedom to operate • Market entry strategies • Complementary technologies to strengthen portfolio • Best funding options/strategies

24. BCIL identifies Indian biotech company & licenses tech Licensee plans to explore US markets & approaches BCIL to allow tech sublicensing TECHNOLOGY TRANSFER AT BCIL Case Study – Post Transfer Role of BCIL RI enters into MoA* with BCIL for commercialization of the technology Vaccine candidate developed at Research Institution Licensee approaches BCIL to revise the Terms of tech transfer BCIL evaluates the request in consultation with industry experts BCIL mediates between the technology developer and the licensee and agrees to allow contract manufacturing BCIL strikes a deal with revised royalty enabling successful launch of the product in the foreign market www.bcil.nic.in

25. TECHNOLOGY TRANSFER AT BCIL Case Study – BCIL as a facilitator for technology validation and commercialization Interest shown by several MNCs on terms of paying after commercialization of the technology Biopesticide Technology developed at Research Institution BCIL agreed to provide sample • BCIL developed MTA • agreement • Facilitated the supply of Sample • Evaluation to be conducted within 90 days. • Experiments conducted on different Insects communicated on 60th day • Biopesticide found effective BCIL facilitated company in decision making through timely independent validation * www.bcil.nic.in

26. TECHNOLOGY TRANSFER AT BCIL Case Study – BCIL facilitates funding for technology validation Very high cost of generating safety & efficacy data for biopesticides Biopesticide Technology developed at Research Institution BCIL approaches Govt. to provide Grant in aid for generating data Govt. agrees for funding • Technology transfer made attractive for SMEs * www.bcil.nic.in

27. TECHNOLOGY TRANSFER AT BCIL Case Study – BCIL finds feasible alternate approach for successful technology commercialization Technology involved use of blood leucocytes for HIV culture Source: Blood bags Ban on sale of Blood bags rendered Technology Unviable Technology Developed at Research Institute • BCIL ensured: • Continuous monitoring • Monthly meetings • Documentation of progress • Concerted follow-up Alternative approach: To establish HIV in continuous cell culture Kit of International Quality successfully developed and released for commercial production

28. TECHNOLOGY TRANSFER AT BCIL Case Study – Overcoming hurdles Independent validation revealed the new technology to be more efficient than conventional sewage seed. • Problems in Tech-Transfer: • Limited User segment • Lack of awareness and market Technology for convenient, reliable and reproducible monitoring of BOD load • BCIL’s Role: • Worked Techno-commercial profile • Estimated Market Potential • Organised Product specific EDPs & Awareness Programmes Successful Technology Transfer www.bcil.nic.in

29. TECHNOLOGY TRANSFER AT BCIL Case Study – BCIL as an active player in Consultancy & Fund syndication Problem in Tech Transfer: Large Funds required for development and scale up of the Technology Technology developed at a Delhi based research Institution Interest shown by potential companies • BCIL’s active Role: • Apprised the company about available Govt. schemes for funding • Assistance in project proposal formulation Project submitted to DBT approved for funding Successful tech-transfer to the interested company www.bcil.nic.in

30. TECHNOLOGY TRANSFER AT BCIL Case Study – Effective IP Management Patent filed by the inventor in USA Technology developed at Research Institution Technology transferred to Industry BCIL facilitated the procedural formalities in changing the Law firm The hired law firm could not effectively mediate between the inventor and the patent office for timely response to the queries raised by USPTO Enabling timely response to the queries raised and efficient follow up www.bcil.nic.in

31. FUTURE TRENDS IN BIOTECHNOLOGY TRANSFER • Major destination for cutting edge technologies • Increased global investment in technology development • Ethical, responsible and value based technology management www.bcil.nic.in

32. THANK YOU !