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Dr. Ravi Dhar on "Technology Transfer: an overview- 2014"


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This presentation deals with broad pricipals of technology Management

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Dr. Ravi Dhar on "Technology Transfer: an overview- 2014"

  1. 1. 22.11.2012 RD_BIRAC_THSTI_IPR 1 An overview on Technology Transfer (Part-I) Ravi Dhar, Ph.D., f-STEM ( 28.10.2014
  2. 2. 16/4/2014 RD_AAU-Gauwhati_October-2014 Resource Acknowledgements NIH PubMed Scientific Community across world Memorial Sloan Kettering Cancer Center DBT BIRAC Library Service NII Various Websites Nature Biotechnology & other Journals  Biotech News (DBT) Healthcare Biotechnology, CRC Press GHI & OTT, Boston University OTT, NIH 2
  3. 3. Resource Acknowledgements •Nature Biotechnology •J. Commercial Technology •Dr. Ravi Dhar: ( •LESI •NII/ BU/NIH/MSK •BIRAC •Various websites 16/4/2014 3 RD_AAU-Gauwhati_October-2014
  4. 4. Technologies:  Drug Molecules/ Vaccines/ Self disposing Stitches/ Medical Devices/ GM Crops  Glybera formally became the first gene therapy to be approved in a regulated market, as the European Commission gave the rubber stamp to the treatment for the ultra-rare inherited disorder lipoprotein lipase deficiency (LPL) (November,2012) Therapeutic Antibodies/Disease testing kits/ Pace maker Stem Cells used for carrying toxic drugs for cure of Brain cancer 22.11.2012 RD_BIRAC_THSTI_IPR 4
  5. 5. Quote on Technology- "This 'telephone' has too many shortcomings to be seriously considered as a means of communication. The device is inherently of no value to us." [Western Union internal memo, 1876] ( 22.11.2012 RD_BIRAC_THSTI_IPR 5
  6. 6. 22.11.2012 RD_BIRAC_THSTI_IPR 6 Industrial Revolution Knowledge Revolution
  7. 7. “Technology transfer is the process of developing practical applications of the results of scientific research which are easy to handle, are of societal relevance & are affordable”. Conceptually the activity has been practiced for many years. In ancient times, Charka, Archimedes or Arabian technologies were notable for applying science to practical problems. However, in the present times, the volume of research is very high, so are the failures (e.g., Vioxx) which should be kept in mind” 22.11.2012 RD_BIRAC_THSTI_IPR 7
  8. 8. Technology transfer is the process by which basic science research and fundamental discoveries are developed into practical and commercially relevant applications and products. Technology Transfer personnel evaluate and manage invention portfolios, oversee patent prosecution, negotiate licensing agreements and periodically review cooperative research agreements already in place. Part of the technology transfer process involves the prosecution of patents which is overseen by the national Patent and Trademark Office. Individuals with advanced degrees in the biomedical sciences are needed to review and process patents in the biotechnology field. Source: Unknown 22.11.2012 RD_BIRAC_THSTI_IPR 8
  9. 9. 22.11.2012 RD_BIRAC_THSTI_IPR 9
  10. 10. Forms in which Knowledge is transferred: General Information 17% Specific Information 56% Procedures/Practice 27% Hardware Objects 28% 22.11.2012 RD_BIRAC_THSTI_IPR 10
  11. 11. Basic Science Research Fundamental Discoveries Commercially Relevant Applications 22.11.2012 RD_BIRAC_THSTI_IPR 11
  12. 12. Innovation Individuals Universities Institutes Industries Invention/ Technology Investment Enterprise Royalty Reap the Fruits of Innovation 22.11.2012 RD_BIRAC_THSTI_IPR 12
  13. 13. Relevance in Current Global Scenario  Requirement of people friendly technologies for health care etc.  Growth of biotech institutes  Increase in number of skilled & semi-skilled people  Increase in international & national collaborations 22.11.2012 RD_BIRAC_THSTI_IPR 13
  14. 14. 22.11.2012 RD_BIRAC_THSTI_IPR 14 Technology Transfer Process New Drug Molecule/Vaccine/Therapeutic Agent (Drug Discovery> Product Development (Delivery Method+ Kinetics of Absorption, Distribution, Metabolism, Excretion)> Clinical Evaluation (Toxicity + Animal & Human Studies)> Invention Disclosure Assessment/ Screening Patent Protection Negotiation Licensing & Monitoring Technology Upscaling (Active Pharmaceutical ingredient> Drug Product(Dosage & Delivery Systems)> Analytic Methods> Stability) Product Development & Commercialization/Marketing Revenue & Monitoring
  15. 15. Technology Transfer Process Research gives rise to a Technology Pre-Disclosure Invention Disclosure Assessment/ Screening Protection Marketing to Find or Form A Licensee Existing Business* *Form Start-Up Business/Company Licensing & Monitoring Commercialization Revenue & Monitoring Deduct Expenses & A Part Reinvested in Research & Education ( 22.11.2012 RD_BIRAC_THSTI_IPR 15
  16. 16. 22.11.2012 RD_BIRAC_THSTI_IPR 16 India
  17. 17. Technology Scenario in India Historic Pre-independent India Post Independent India 22.11.2012 RD_BIRAC_THSTI_IPR 17
  18. 18. Technology Transfer in India (Historical)  Life Philosophy : Vasudeva Katumbham (the universe is my home; concept of selflessness)  Technologies in ancient India: Kajal; Ashoka Pillar; surgical methods & tools; concept of “ 0 “ etc.  Documentation poor or eroded !!  Let us change now! 22.11.2012 RD_BIRAC_THSTI_IPR 18
  19. 19. Evolution of Innovations in India (Recent) Three Key Players (1907 - 2014): Industry Tata Iron & Steel(1907) Hindustan Aeronautics(1940) First IBM imported(1961) Indian Railway Reservation System(1987) Software Development (1986) Issuance of H-1 Visas to Indian’s Universities Thomson Engineering College, Calcutta, Bombay, Madras(1947) IISc Bangalore(1911), C.V. Raman gets Nobel Prize (1930) IIT (1949), Computer Society of India(1965), ERNET (1986) Government Telegram(1951), Railways (1953) Atomic Energy Commission(1948) APSARA(1956), SRO(1961) Automation Committee Report(1972) SLV Launch(1980), PSLV Rocket(1994), Moon mission (2008) SW Technology Parks(1991), PSVL, Mars Mangalyaan (2014) Biotechnology Revolution (1998 onwards) 22.11.2012 RD_BIRAC_THSTI_IPR 19
  20. 20. Protection of Inventions: Pre-independent India Technology dissemination inhibited/ plugged by modifying the Labor Welfare Rules in British India - 1942 22.11.2012 RD_BIRAC_THSTI_IPR 20
  21. 21. Post Independent India o It takes little while to build up resources o Affordable Drugs o Patent Laws of 1970 o Lack of Funding in S&T sector o Agriculture was a priority o Governance problems 22.11.2012 RD_BIRAC_THSTI_IPR 21
  22. 22. Post Independent India (Recent) Public research – Quest for self reliance. Military, health care, agriculture … Socialist economic policy within a democratic political framework….. Central control.. State production – control of private production. No focus on technology transfer. Change of direction in 1991… 22.11.2012 RD_BIRAC_THSTI_IPR 22
  23. 23. Effect of Economic growth (I)  24 years of successive growth phase  Successive upward movement in technology application  Access to global technologies accelerate “in- licensing” in several sectors.  Engineering, chemicals, life science products, mining and metals.. significant technology up gradation.  Combined efforts of public and private sector. 22.11.2012 RD_BIRAC_THSTI_IPR 23
  24. 24. Current Status (I) India has many things to do as it gets in the frontline of economic powers – one of them is accelerating technology transfer process and mechanism Narrow the distance between today’s reality and tomorrow’s potential. 22.11.2012 RD_BIRAC_THSTI_IPR 24
  25. 25. Private sector Research (I) Size limits commitment to Research.. 1991 policy allows global private investment in research Joint ventures stimulate technology transfer Indian companies with licensing track record known for accelerated research investment. Myth that technology sourcing will limit in-country capability is broken.. India Inc., accesses several global technologies in frontier segments, many from global public research enterprises. 22.11.2012 RD_BIRAC_THSTI_IPR 25
  26. 26. Biotech Sector (I)  National Biotech Policy  National Policy of Human Clinical Trials  National/ State Tech Parks & Incubators  Policy on Stem Cells  National Biotech regulatory Authority??  ASSOCHAM Delhi Declaration 2006  Improved Sales Tax Laws  Efforts for One Window Clearance! ( 22.11.2012 RD_BIRAC_THSTI_IPR 26
  27. 27. 22.11.2012 RD_BIRAC_THSTI_IPR 27 Cena_hand.pdf
  28. 28. 22.11.2012 RD_BIRAC_THSTI_IPR 28 Black Hole Rips a Star; Courtesy : NASA
  29. 29. 22.11.2012 RD_BIRAC_THSTI_IPR 29 (Source: Nature Biotechnology)
  30. 30. Biotech Clusters in India Bangalore Hyderabad Ahmadabad Delhi Pune 22.11.2012 RD_BIRAC_THSTI_IPR 30
  31. 31. Current Hub Of Biotech Activity in India - Bangalore 22.11.2012 RD_BIRAC_THSTI_IPR 31
  32. 32. Western India : Revenues US $ 800 million Aurangabad : Agri-/bio-manufacturing; Mumbai : Bio-pharmaceuticals & Stem Cell Research; Ahemdabad/ Baroda : Agri-biotech, Bio-pharmaceuticals, Enzymes, Bio-information & Contract Research Pune : Agri-biotech, Bioinformatics, Bio-processing, Stem Cell Research & Vaccines Southern India : Revenues US $ 600 million Chennai : Bioinformation, Bio-pharmaceuticals, Genomics, Marine Biotech. 48 Firms Hyderabad : Vaccines Mysore : Bio-diesel Bangalore : Industrial Biotech Northern India : Revenues US $ 130 million Delhi/ Gurgaon/ Noida : Agri-biotech, Bio-fuels, Genomics Lucknow : Bio-information & Bio-pharmaceutics 48 Firms 115 Firms 120 Firms 22.11.2012 RD_BIRAC_THSTI_IPR 32
  33. 33. Emerging Trends in Research Models(I) Indian S&T strength Trends in technology development Enabling mechanisms Emerging segments for technology leadership Research models – cross country, cross functional Contract and collaborative research 22.11.2012 RD_BIRAC_THSTI_IPR 33
  34. 34. Enhanced level of risk taking in research (I) Positive change to risk averse mindset 80s and 90s- demonstrate Indus entrepreneur success in silicon valley – 6% of total value come from indus entrepreneurs.. India joins global consortium with significant funding and long term commitment …. (telecom, public health(AIDS), genomics, environment).. 22.11.2012 RD_BIRAC_THSTI_IPR 34
  35. 35. 22.11.2012 RD_BIRAC_THSTI_IPR 35
  36. 36. Have we discovered Original Drug Molecules ? A) Negative Attitude: Generally ‘NO’ few years ago! Why ! (Chalta Hai Attitude) ? B) Positive Attitude: 10 out of 60 molecular or protein structures of genomes of infectious diseases solved in India  Ranbaxy  Dr. Reddy’s  Biocon  Panacea  (5-6 Drug Molecules for FDA approval in USA : Progress) ???? 22.11.2012 RD_BIRAC_THSTI_IPR 36
  37. 37. First Indigenous Non-Chemical Entity First Homegrown NCE (New Chemical Entity): Name : Balaglitazone (DRF: 2593) – a Drug Properties : Anti-type 2 Diabetes Drug Jointly developed by : a) Dr. Reddy’s Laboratories (India) b) Rheoscience (a Dutch Pharma Co.) (“The Times of India, New Delhi, India; August 2nd, 2007) 2012: Issues?????? 22.11.2012 RD_BIRAC_THSTI_IPR 37
  38. 38. 22.11.2012 RD_BIRAC_THSTI_IPR 38
  39. 39. 22.11.2012 RD_BIRAC_THSTI_IPR 39
  40. 40. 22.11.2012 RD_BIRAC_THSTI_IPR 40
  41. 41. The future as we perceive (I)***  India will be among the major out-licensing destinations.  Focus on cutting edge research – telecom, aerospace, information technology, applications, human health, biotechnology, natural resource management….  Global collaborative research will be the focus.  Public research will complement private research with resources and basic research capabilities.  Technology transfer will be augmented through responsive, accountable technology management organs.  Global investment will drive Indian research for global good. 22.11.2012 RD_BIRAC_THSTI_IPR 41
  42. 42. The future as we perceive (I)(Contd) India will a strong destination for in-licensing and out-licensing Public and private resources will complement future research efforts International investments will drive technology transfer growth Ethical, responsible and value based technology management will drive economic growth. 22.11.2012 RD_BIRAC_THSTI_IPR 42
  43. 43. 22.11.2012 RD_BIRAC_THSTI_IPR 43 Think Big
  44. 44. How to Protect Inventions ? 22.11.2012 RD_BIRAC_THSTI_IPR 44 Secrecy Secure data Strengthen Technology
  45. 45. Importance of Proof of Concept  Before demonstrating proof of concept (POC)- Low value  Once POC demonstrated – product value increases 22.11.2012 RD_BIRAC_THSTI_IPR 45
  46. 46. Disposal of Technologies We may get a Patent for a Technology; or License it to an Industry after :-  Evaluation : Apply “Go- No Go –Kill” concept  Upscale  License  Monitor  Royalty 22.11.2012 RD_BIRAC_THSTI_IPR 46
  47. 47. Showcase your Technologies to the market  Participate in Trade Shows  Organize Trade Shows  Publish Articles  Write Technology available in business journals  Advertise new inventions in web based market places to expose people to availability  Arrange conferences to highlight scientific & technology transfer achievements 22.11.2012 RD_BIRAC_THSTI_IPR 47
  48. 48. Technology Valuation 22.11.2012 RD_BIRAC_THSTI_IPR 48
  49. 49. Value Grid mapping of Technology / Product Portfolios 22.11.2012 RD_BIRAC_THSTI_IPR 49
  50. 50. Traditional Technology Valuation  Cost Method  Industry Standard Royalty Rates  Discounted Cash Flows  Relief from royalty  Decision trees Additional Valuation Considerations:  Citation Analysis  Technology Strength  Innovation Cycle Time  Technology Cogency  Sustainability in Opposition 22.11.2012 RD_BIRAC_THSTI_IPR 50
  51. 51. Organizations with Integrated Innovation & IP Management have High Quality (economically valuable) Patent Portfolios Patent Quality Impact on Performance (+) High Potential (++) Innovation Leaders Losers (-) Activists (--) (low) (high) Patents/R&D Expenditure Ernst, 2008; Chicago 22.11.2012 RD_BIRAC_THSTI_IPR 51
  52. 52. 22.11.2012 RD_BIRAC_THSTI_IPR 52 Technology Mapping/Transfer Identify Organization Identify Technology Identify Industrial Partner Negotiate Transfer to Industry Negotiate
  53. 53. Follow up on a technology - Maintain close rapport with the inventor - Update your database on invention disclosures - Understand the modifications - Be in close touch with industry - Identify the players in commercial sector 22.11.2012 RD_BIRAC_THSTI_IPR 53
  54. 54. Protection of Innovations Patenting  Confidential Disclosure Agreements (CDAs)  Licensing  All of the above 22.11.2012 RD_BIRAC_THSTI_IPR 54
  55. 55. Patents  Novelty  Inventive step  Enablement :- no requirement of “undue experimentation”  Industrial Applications 22.11.2012 RD_BIRAC_THSTI_IPR 55
  56. 56. Technology Transfer Process Research Pre-Disclosure Invention Disclosure Assessment/ Screening Protection Marketing to Find or Form A Licensee Existing Business* *Form Start-Up Business/Company Licensing & Monitoring Commercialization Revenue & Monitoring Reinvest in Research & Education 22.11.2012 RD_BIRAC_THSTI_IPR 56
  57. 57. 22.11.2012 RD_BIRAC_THSTI_IPR 57
  58. 58. 22.11.2012 RD_BIRAC_THSTI_IPR 58 Source:
  59. 59. 16/4/2014 59 RD_AAU-Gauwhati_October-2014 Level of Maturity of Technology Is Essential for consideration for further Development by a Licensee
  60. 60. Technology Screening/ Evaluation  Technology Maturity  Competing Products  Competing Patents  Competing R & D  Market Barriers  Commercialization Strategy Considerations  Potential Targets (V. Imp.: Outsourcing only under Strict Confidential Agreement) 22.11.2012 RD_BIRAC_THSTI_IPR 60
  61. 61. Technology Transfer Process Technology (A Vaccine/Therapeutic Agent/GM Crop/Medical Devices etc) (Drug Discovery> Product Development (Delivery Method+ Kinetics of Absorption, Distribution, Metabolism, Excretion)> Clinical Evaluation (Toxicity + Animal & Human Studies)> Invention Disclosure Assessment/ Screening Patent Protection Licensing & Monitoring Technology Transfer (Active Pharmaceutical ingredient> Drug Product(Dosage & Delivery Systems)> Analytic Methods> Stability) Product Development, Production & Commercialization Revenue & Monitoring ( 16/4/2014 RD_AAU-Gauwhati_October-2014 61 University/ Institute/ Organization Established or Start-up Company /Entrepreneur or a Big Company
  62. 62. Technology/Innovation Management Process 1.Idea/Proof of Concept : Technical Assessment 2.File a Patent (Prior Art Search: Novelty/non-Obviousness/Utility) /  (Publish Manuscript) 3.Grant Process at Patent Office : Be patient 4.Find an Industrial Partner : Be Patient or float your Start- 5. up Company 6.MoUs_NDA : TTO or Attorney or Agencies 7.Licence , DA : TTO or Attorney 8.Exchange Know-how_MoUs : You and Industry 9.Demand Signing Amount : You + Industry+ University 10.Furnish Data (Importance of Record Book): You + Industry 11.Freedom to Operate Analysis : TTO/ Patent Attorney 12.Industrial Partner will Validate Data>Upscale>Pilot run 13.Milestone Payments : You + University 14.Industry will Manufacture, Commercialize, Market Product 15.Distribution of Royalty on Sales : You + University + Industry 16/4/2014 RD_AAU-Gauwhati_October-2014 62
  63. 63. 16/4/2014 RD_AAU-Gauwhati_October-2014 63 Value of Technology (Drug/Vaccine/Medical Device/GM Crop) Proof of Concept Untested Product/ Animal or Field Trials Product Level(Low) High Category Concept/HighValue Low Category/Low Value Tested Product / Human Clinical Trials Phase I Product Level (Better) Value Low Value Preposition Debatable Value Debatable?? Higher Value Preposition Field Tested Product/ Human Clinical Trials Phase III
  64. 64. 22.11.2012 RD_BIRAC_THSTI_IPR 64
  65. 65. Technology Transfer Agreements MoUs : Memorandum of Understanding CDAs : Confidential Disclosure Agreements MTAs : Material Transfer Agreements IIAs : Inter-institutional Agreements CRADAs : Coop. Research & Develop. Agreement (sponsored research agreements) 22.11.2012 RD_BIRAC_THSTI_IPR 65
  66. 66. 22.11.2012 RD_BIRAC_THSTI_IPR 66 Technology Transfer Offices
  67. 67. Technology Transfer Offices Organizational Structure 22.11.2012 RD_BIRAC_THSTI_IPR 67
  68. 68. Technology Transfer Offices Different Models India: DRDO, Delhi NII, Delhi CSIR, Delhi IISC, Bangalore U.S.A. BU NIH Stanford MIT NYU SUNY 22.11.2012 RD_BIRAC_THSTI_IPR 68
  69. 69. Deficiencies in the Current Tech Transfer System/ Offices - Need of a Data Bank for our Patents & Technologies - Learn how to Identify & Evaluate technologies - Promote commercialization of these technologies - Faculty and students should foster an entrepreneurial environment - Least interactions between the research community, corporate and financial communities at the moment - Absence of a Regional Technology Transfer Capital Finance Pool of the of the participating organizations/countries; and - Invest assets in venture capital partnership and co-investment opportunities as per requirement of the region. - Build capacity to train personnel in Technology Transfer Issues - Understand the conflict of interest issues - Manage technologies generated at participating organizations 22.11.2012 RD_BIRAC_THSTI_IPR 69
  70. 70. Restructuring the current Technology Transfer Offices  Change in mind set  Technology transfer office should be separated from institutes so as to function independently  People with multi-skilled capability need to run the show  Decentralize 22.11.2012 RD_BIRAC_THSTI_IPR 70
  71. 71. Capabilities of the Staff in Modern Technology Transfer Offices  Patience & Good Attitude  People friendly  Capability to multitask  Capacity to maintain confidentiality  Should understand science  Should understand legal implications  Should have capacity to sit for long hours on computer searches 22.11.2012 RD_BIRAC_THSTI_IPR 71
  72. 72. 22.11.2012 RD_BIRAC_THSTI_IPR 72 Support Groups For Technology Transfer
  73. 73. Framing Technology Transfer Groups for Support India Government support : DBT, CSIR, ICMR, IARI Private Partners e.g. : Sathgaru, Skyquest U.S.A. !!! AUTM !!! 22.11.2012 RD_BIRAC_THSTI_IPR 73
  74. 74. National Knowledge Commission (“Be recognized as a player in the creation, application and dissemination of knowledge”) ******* National Innovation Foundation (more than 100 technologies registered from India & Abroad) 22.11.2012 RD_BIRAC_THSTI_IPR 74
  75. 75. Global Aspects of Technology Transfer  The impact of WTO-TRIPS on developing countries  Update on Bayh-Dole and its impact on development of useful health technologies**  The role of compulsory licensing and parallel trade in biotechnology diffusion  Key issues in ensuring availability of health products in developing countries  International treaties and technology transfer  Case studies from developing countries  Barriers for technology transfer to developing countries  New research methods for analyzing technology transfer  Technology transfer for bio-terrorism 22.11.2012 RD_BIRAC_THSTI_IPR 75
  76. 76. Corporate Technology Transfer Debates Technology Used for Import Substitution •Interest of MNCs : Price & Accounting Problems •Restrictions on export •Gave rise to Indian Patent Laws of 1970 •However, in Medicine we still see Significant Import Substitution Technology used for Export •Interests Aligned – both want best technologies •Dominant pattern with Globalization •Laws of 1970’s disappeared ( 22.11.2012 RD_BIRAC_THSTI_IPR 76
  77. 77. Public Private Partnerships Question of Survival Question of Self Esteem Some of us are inquisitive Some of us genuinely want India to progress PPP is sensible to utilize resources of both groups 22.11.2012 RD_BIRAC_THSTI_IPR 77
  78. 78. Developed World Public Sector Developed World Private Sector Developing World Private Sector Developing World Public Sector The Public Private Partnerships The New Paradigm ( 22.11.2012 RD_BIRAC_THSTI_IPR 78 BIRAC
  79. 79. Organizational Structure (as in BU) Technology Transfer Protects intellectual property: Patenting; marketing of technologies; and negotiation of licenses with industry or faculty start-ups. Innovation and Entrepreneurship Advice, guidance and support to those in the research community exploring the possibility of starting a new company. Business Incubation Offers early-stage companies state-of-the-art office space, laboratories and a host of support services for launching new technology ventures. Corporate Business Development Seeks to establish partnerships with industry around the creation and development of Institute or Universities’ applied technologies. Venture Capital Investments Invests Institute assets in top tier venture capital funds, makes co- investments in early-stage companies and raises capital for Institute start-ups. ( 22.11.2012 RD_BIRAC_THSTI_IPR 79
  80. 80. 22.11.2012 RD_BIRAC_THSTI_IPR 80 Possible Organization for Developing Technology Transfer Office in Academic Environment for India
  81. 81. Director/ Head Technology Transfer (Identify an Invention for Protection) Entrepreneurship & Business Incubation Business Development & Venture Capital International Technology Related Collaborations Technology Licensing Assistance of Legal Experts (India & Participating countries)** Creation of Technology Bank on Health/Agriculture/Environment/ Aqua/ Industrial Technologies Technology Location/ Detection & Evaluation Sensitization: Workshops & Training Programs Subject Expert Committees Technologies from Universities/Institutes (DBT Funded) Administrative Offices at X/ Y/ Z 22.11.2012 RD_BIRAC_THSTI_IPR 81 RD/2008
  82. 82. 22.11.2012 RD_BIRAC_THSTI_IPR 82 Technology transfer Office – India Separate Office Separate Officer Secrecy & Protection of Data Technology Transfer Policy
  83. 83. 22.11.2012 RD_BIRAC_THSTI_IPR 83
  84. 84. Inventorship issues Did the person : Contribute specific ideas that resulted in development Contribute more than labor to one or more of the inventive or technically significant features of the invention Make practical and/or concrete suggestions that contributed to the invention? Provide a specific design or experimental improvement that made the invention operable? Conceive an inventive step or part of the invention that you can identify? Have some role in the final conception of an invention as it is (will be) patented? If answer to one or more questions is “yes” the person is an inventor otherwise he is not an inventor Other issues: In spite of the fact that a person answers “yes” to the following question, he/ she is not an inventor:- Did his ideas serve as a general goal or objective of the research? Were you retained or employed to reduce the concept to practice? Did you contribute ideas while the invention was being developed, but those ideas don’t contribute to the invention in it’s final form or as disclosed in the patent application 22.11.2012 RD_BIRAC_THSTI_IPR 84
  85. 85. Licensing Demonstrate the Proof of Concept Network for Commercialization Negotiate Fix Royalties Pay Taxes Enjoy Life 22.11.2012 RD_BIRAC_THSTI_IPR 85
  86. 86. Role of Licensing Office (contd.) What should not be done ( !!) - Analysis of prior art - Preparation of Patents - Detailed marketing studies - Preparation of business plans - Calculation of Royalty 22.11.2012 RD_BIRAC_THSTI_IPR 86
  87. 87. Issues in licensing  Standstill agreements  Field of use  Scope of agreement  Sub-licensing considerations  Structuring of indemnities 22.11.2012 RD_BIRAC_THSTI_IPR 87
  88. 88. Negotiating Licenses: Issues Determining when/what to negotiate Strengthening walk-away points and avoiding argument dilution Detecting and defeating lies Managing concessions Value creating and value sharing 22.11.2012 RD_BIRAC_THSTI_IPR 88
  89. 89. 22.11.2012 RD_BIRAC_THSTI_IPR 89
  90. 90. 22.11.2012 RD_BIRAC_THSTI_IPR 90
  91. 91. 22.11.2012 RD_BIRAC_THSTI_IPR 91
  92. 92. 22.11.2012 RD_BIRAC_THSTI_IPR 92
  93. 93. Effect of Global Alliances & Current Indian Biotechnology Scenario Warrant Modifications of our of our Technology Transfer Offices Indian Bio-Tech Market (2007) : US $ 2 Billion (2015) : US $ 20 Billion 22.11.2012 RD_BIRAC_THSTI_IPR 93
  94. 94. 22.11.2012 RD_BIRAC_THSTI_IPR 94
  95. 95. Technology Transfer Office is no more in a Room or a Building Example:  JEV vaccine NII + Panacea India Example: (  Meningitis vaccine for Africa [PATH/ WHO+ CDC, UNICEF, MSF, World Bank+ African holders][Price $ US 0.40 per dose] - Dutch Company : to produce PS (protein conjugate vaccines) - NIH, USA : develop conjugation method - Serum Institute of India : to provide TT & manufacture vaccine - Rotavac  Technologies related to Agricultural Produce/ DuPont India/GM crops 22.11.2012 RD_BIRAC_THSTI_IPR 95
  96. 96. 22.11.2012 RD_BIRAC_THSTI_IPR 96 If India has to change we should integrate!*
  97. 97. Optimization of Resources & Virtual Organizations (Pool Resources from different countries and help each others) DNDi (TB + other) : Drugs for Neglected Diseases Initiative AERAS : Global TB Foundation (Bill & Melinda Gates) MMV : Medicines for Malaria Venture (1999) VDP : Vaccine Development Program IPM : International Partnerships for Microbicides (2002) FIND : Foundation for Innovative New Diagnostics (2003) BVGH : BIO Ventures for Global Health PIPRA : Public Intellectual Property resources for Agriculture 22.11.2012 RD_BIRAC_THSTI_IPR 97
  98. 98. What do All These Organizations Do?  To Identify Targets for Development of New Drugs & diagnostics  Identify Market Opportunities for Neglected Diseases  Work with Companies to build Global Health Strategies  Expanded Access to Information & Resources  Facilitate New Partnerships  Secure Finances for above 22.11.2012 RD_BIRAC_THSTI_IPR 98
  99. 99. 22.11.2012 RD_BIRAC_THSTI_IPR 99
  100. 100. 22.11.2012 RD_BIRAC_THSTI_IPR 100 Strike a Balance
  101. 101. “Anyone who shows interest in the fellowship,” Dhar says, “should be ready to change his mental orientation, should have determination to spend long hours on patent Web sites, to understand how to support start-up companies, and also develop a close rapport with venture capital firms.” Boston University Today, University Headlines, October 24, 2006 22.11.2012 RD_BIRAC_THSTI_IPR 101
  102. 102. Acknowledgements DBT BIRAC Library Services Dr. Altaf Lal, US Embassy, New Delhi Dr. Karen H. Antman, BU Dr. Gerald T. Keusch, BU Dr. Ashley Stevens, BU Dr. Catherine Ives, BC FICCI/ CII NIH, USA Dr. Luis Salicrup, NIH, USA AUTM, U.S.A. 22.11.2012 RD_BIRAC_THSTI_IPR 102
  103. 103. 22.11.2012 RD_BIRAC_THSTI_IPR 103 Thank You (