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PRESENTATION BY:

DR. PURNIMA SHARMAMANAGING DIRECTOR

BIOTECH CONSORTIUM INDIA LIMITEDNEW DELHI, INDIA

AUGUST 18, 2008

NATIONAL EXPERIENCES IN TRANSFER OF BIOTECHNOLOGIES

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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 )

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BIOTECHNOLOGY TRANSFER IN INDIA: UNIQUE ADVANTAGES

• HIGH QUALITY HUMAN RESOURCES

• GOVERNMENT SUPPORT AT HIGHEST LEVEL

• STRONG INTELLECTUAL PROPERTY (IP) PROTECTION SYSTEM

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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

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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

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BIOTECHNOLOGY TRANSFER IN INDIA: STRONG IP PROTECTION SYSTEM

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.

AMENDMENTS IN INDIAN PATENT ACT,1970

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MODELS FOR TECHNOLOGY TRANSFER

• University Model

• Public Private Partnership Model

• Technology Incubators

• Specialized Technology Transfer Agencies (BCIL)

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University Model

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IndustryUniversity/Scientist concerned

Involves direct interaction between- Scientist and Industry

Technology reaches Industry by

• Publications made by Scientist

• Patents filed

• Presentation in Conference

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Public Private Partnership (PPP) Promotion Schemes

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• 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)

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Funding options based on Life Cycle

Pre-seedfunds

1 – 5 crores

Seed and early-stagefinance

5 – 20 crores

Traditionalfinance

> 20 crores

Idea Incubation Development Finance Growth Capital

Gestation

R&D

Founders / Grants Angel Investors

/ Grants

Venture Capital Funds & Corporate Investors

Pilot Test

Roll out

Growth

Expansion

Maturity

Banks

IPO, PIPEs,Acquisition

Revenue

Time

Routine Debt

High RiskDebt / Warrants

Funding Pit

Risk Mitigation Needed

Gestation

R&D

Founders / Grants Angel Investors

/ Grants

Venture Capital Funds & Corporate Investors

Pilot Test

Roll out

Growth

Expansion

Maturity

Banks

IPO, PIPEs,Acquisition

Revenue

Time

Routine Debt

High RiskDebt / Warrants

Funding Pit

Risk Mitigation Needed

Mature Financial MarketSystematic Intervention Required

SBIRINMITLI, SBIRI PRDSF, TDDP

TDB, Venture Capital

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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

BIOTECH INCUBATORS

Contd.

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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

BIOTECH INCUBATORS

Contd.

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Biotech Incubators

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• 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

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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$ 1.3 million

BiosafetyInformation

ServicesPatent Facilitation

Technology Transfer

Human Resource Development

ConsultancyProject

ManagementCertification

Services

: US$ 2.3 million

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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

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Technology Identification

MODEL ADOPTED BY BCIL

• Scouting for patents, invention disclosures etc.• Assessment and follow up of potential ongoing projects

TechnologyEvaluation

& Packaging

• 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

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.

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Contd.

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Technology Transfer

Monitoring and Consultancy

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

• To facilitate Demonstration • Monitoring- Review meetings• Consultancy• Fund Syndication

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MODEL ADOPTED BY BCIL

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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

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TECHNOLOGY TRANSFER AT BCIL

Technologies Transferred

S.No Technology Technology Developer Year Licensee

1 Biopesticide TNAU,Tamil Nadu 1995 Crop Health Products Ltd., Ghaziabad

2 Biopesticide TNAU, Tamil Nadu 1995 Maharashtra Oilseed Growers Federation, Jalgaon

3 Biopesticide TNAU, Tamil Nadu 1996 Hoechst Schering AgroEvo Ltd., Mumbai

4 Biopesticide TNAU,

Tamil Nadu

1996 Godavari Sugar Mills Ltd., Mumbai

5. HIV Diagnostics (Western Blot) Cancer Research Institute, Mumbai

1997 J. Mitra & Co. Ltd., Delhi

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Technologies Transferred

S.No Technology Technology Developer Year Licensee

6 HIV Diagnostics (ELISA) National Institute of Immunology, Delhi

1998 Ace Diagnostics & Biotech Ltd., Delhi

7. BODSEED Centre for Biochemical Technology, Delhi

1999 Indo Bioactive Labs (P) Ltd., Pune

8 Hepatitis-A Diagnostics National Institute of Virology, Pune

2000 Bharat Biotech International Ltd., Hyderabad

9 Biopesticide Regional Research Laboratory, Nammu

2000 Bee Zed Biotech

10 Alphafetoprotein Diagnostics Indian Institute of Chemical Biology, Kolkata

2000 Shantha Biotechnics Pvt. Ltd., Hyderabad

TECHNOLOGY TRANSFER AT BCIL

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TECHNOLOGY TRANSFER AT BCIL

Technologies Transferred

S.No TechnologyTechnology Developer

Year Licensee

11 Reproductive Hormones Diagnostics Institute for Research in Reproduction, Mumbai

2000 Zydus Cadila Healthcare Ltd., Ahmedabad

12 Dengue, Jap.E, West Nile Diagnostics National Institute of Virology, Pune

2000 Zydus Cadila Healthcare Ltd., Ahmedabad

13 Recombinant Typhid vaccine AIIMS 2006 USV Ltd. Mumbai

14 Recombinant Anthrax Vaccine Jawaharlal Nehru University,

New Delhi

2001 Panacea Biotec Ltd.,

New Delhi

15. Production of Bollcure The Energy & Resources Institute, New Delhi

2007 Sri Biotech Laboratories Pvt. Ltd., Hyderabad`

16. Diagnosis of tuberculosis by smear, microscopy, culture and polymerase chain reaction

All India Institute of Medical Sciences, New Delhi

2008 Arbro Pharmaceuticals Ltd., New Delhi

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TECHNOLOGY TRANSFER AT BCIL

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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

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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

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TECHNOLOGY TRANSFER AT BCIL

Case Study – Post Transfer Role of BCIL

Vaccine candidate developed at Research Institution

RI enters into MoA* with BCIL for commercialization of the technology

BCIL identifies Indian biotech company & licenses tech

Licensee plans to explore US markets & approaches BCIL to allow tech sublicensing

Licensee approaches BCIL to revise the Terms

of tech transfer

BCIL strikes a deal with revised royalty enabling successful launch of the

product in the foreign market

BCIL mediates between the technology developer and the licensee and agrees to allow contract manufacturing

BCIL evaluates the request in consultation with industry experts

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TECHNOLOGY TRANSFER AT BCIL

Case Study – BCIL as a facilitator for technology validation and commercialization

Biopesticide Technology developed at Research Institution

*

Interest shown by several MNCs on terms of paying after commercialization of the technology

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

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TECHNOLOGY TRANSFER AT BCIL

Case Study – BCIL facilitates funding for technology validation

Biopesticide Technology developed at Research Institution

*

Very high cost of generating safety & efficacy data for biopesticides

BCIL approaches Govt. to provide Grant in aid for generating data

Govt. agrees for funding•Technology transfer made attractive for SMEs

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TECHNOLOGY TRANSFER AT BCIL

Case Study – BCIL finds feasible alternate approach for successful technology commercialization

Technology Developed at Research Institute

Technology involved use of blood leucocytes for HIV

culture

Source: Blood bags

Ban on sale of Blood bags

rendered Technology Unviable

Alternative approach: To establish HIV in continuous

cell culture

BCIL ensured:

•Continuous monitoring

•Monthly meetings

•Documentation of progress

•Concerted follow-up

Kit of International Quality successfully developed and released for commercial production

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TECHNOLOGY TRANSFER AT BCIL

Case Study – Overcoming hurdles

Technology for convenient, reliable and reproducible monitoring of BOD load

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

BCIL’s Role:

•Worked Techno-commercial profile

•Estimated Market Potential

• Organised Product specific EDPs & Awareness Programmes

Successful Technology

Transfer

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TECHNOLOGY TRANSFER AT BCIL

Case Study – BCIL as an active player in Consultancy & Fund syndication

Technology developed at a Delhi based research Institution

Problem in Tech Transfer: Large Funds required for development and scale up of the Technology

BCIL’s active Role:

• Apprised the company about available

Govt. schemes for funding

• Assistance in project proposal formulation

Successful tech-transfer to the interested company

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Interest shown by potential companies

Project submitted to DBT approved for funding

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TECHNOLOGY TRANSFER AT BCIL

Case Study – Effective IP Management

Technology developed at Research Institution

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Enabling timely response to the queries raised and

efficient follow up

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

Patent filed by the inventor in USATechnology transferred to

Industry

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FUTURE TRENDS IN BIOTECHNOLOGY TRANSFER

• Major destination for cutting edge technologies

• Increased global investment in technology development

• Ethical, responsible and value based technology management

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THANK YOU !