Dr. Ravi Dhar on Intellectual Property & Technology Management_ University of Kashmir_2014_f

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Dr. Ravi Dhar on Intellectual Property & Technology Management_ University of Kashmir_2014_f

  1. 1. RAVI DHAR REVIEWS: “UNDERSTANDING INTELLECTUAL PROPERTY & TECHNOLOGY MANAGEMENT FOR PRODUCT DEVELOPMENT IN CURRENT GLOBAL SCENARIO” Ravi Dhar, Ph.D., f-STEM in.linkedin.com/pub/ravi-dhar/18/71b/895 (Email: rdhar_in@yahoo.com) University of Kashmir, Srinagar 16/4/2014 1RD_UOK_April-2014 INTERNATIONAL CONFERENCE ON CELLULAR AND MOLECULAR MECHANISMS OF DISEASE PROCESSES (April 13-16, 2014) 16.4.2014
  2. 2. 16/4/2014RD_UOK_April-2014 2 Happy 2014 to Colleagues & Scholars
  3. 3. Acknowledgements 16/4/2014RD_UOK_April-2014 3  DBT, GoI  NII  NIH  USDA, JHU, NYU  BU {Drs. Gerald Keusch, Ashley Stevens & Altaf Lal}  Kellogg’s Business School, Center for Biotechnology, North Western University  Nature Biotechnology, International Journal of Technology, Bio- Materials, Nature Nano-technology , MIT Technology Review, MedGadget  Various Websites (USPTO, IPO) , Books, NYT  Several Colleagues (Vinita & Sibi @ BIRAC)
  4. 4. 16/4/2014RD_UOK_April-20144 Special Thanks: University of Kashmir Department of Biotechnology, KU Dr. Raies Qadri
  5. 5. 16/4/2014RD_UOK_April-20145 A bio- engineered heart-valve, a small example of the top-down approach. Courtesy of Wikimedia Commons
  6. 6. 16/4/2014RD_UOK_April-20146 Fast New Test could find Leprosy before Damage is Lasting American researchers developed the test, and Brazil’s drug- regulatory agency registered it last month. A Brazilian diagnostics company, OrangeLife, will manufacture it on the understanding that the price will be $1 or less. “This will bring leprosy management out of the Dark Ages,” said Dr. William Levis, who has treated leprosy patients at a Bellevue Hospital outpatient clinic for 30 years. A new diagnostic test has been created to diagnose leprosy out of a smart-phone and a simple test strip reader
  7. 7. 16/4/2014RD_UOK_April-20147 Problems Big or Small Need Solutions Finding Solutions would also lead to Entrepreneurship & Jobs Related Education Technologies/Solutions Commerce
  8. 8. 16/4/2014RD_UOK_April-20148 Technologies are Generated by Act of Mind. The commodity Developed or produced is thus called as Intellectual Property
  9. 9. WISH LIST Want an ideal Device for Detection of Cancer from Human Saliva Want a tea + saffron mix which has higher levels of anti-oxidants & can cure flu  Want quick Detection of Drug Resistant Cerebral Malaria by a simple Staining method Want a blood thinner drug from a local plant “A” A folding but flying car which can occupy a small space 16/4/2014RD_UOK_April-20149
  10. 10. 16/4/2014RD_UOK_April-201410 How to full-fill the Wish List? Problems are Solved by Innovative thinking; so - Innovate! Innovate! Innovate!
  11. 11. 16/4/2014RD_UOK_April-201411 Academic or Industry Led R&D Basic & Applied Research Funding (Public or Private) Both Applied or Basic Research result In Product Development for Public Consumption
  12. 12. 16/4/2014 RD_UOK_April-2014 12 IP Protection 1 2 3 4 6 7 5
  13. 13. Definition of Intellectual Property? 16/4/2014RD_UOK_April-2014 13 “A mental or intellectual activity” which result in useful Technologies or products like vaccines, drugs, medical devices, expression vectors, plant varieties, better varieties of Saffron, energy solutions etc. The technologies or products may be given legal protection IP is generated by Inventors or Innovators Intellectual Property includes Patents, Copyright, Trade Mark, Trade Secrets, Geographical Indicators, Protection of Plant Varieties etc.
  14. 14. Products (=inventions) & Type of Legal Protection: 16/4/2014RD_UOK_April-2014 14 Invention/Product Legal Protection Humira mAb, Gene Sequencers, PCR machine, Pandyflu, Immuvac Patent/ Trade Secret Nescafe, FloFish/ARTSK_NII/ Gillette Soap Trade Mark Maruti, Honda Model XXX Design Registration Internet Explorer, Gene Sequences & Music Copyright Coke, Techniques to generate enzymes Trade Secrets Traditional Knowledge & New Plant Varieties Protection of Plant Varieties Act South Indian Saress, Bengal Cloth, Bikaneri Bhujia Geographical Indicators
  15. 15. 16/4/2014RD_UOK_April-201415 Research to Identify problems & Opportunities Communicate & Advance Test & Select Concepts Develop Concepts Ideation: Generate Ideas Analysis & Synthesize Idea Formulate QuestionsInnovationSystem
  16. 16. 16/4/2014RD_UOK_April-201416 What is innovation? “The process of translating an idea or invention into a product or service that creates value due to its’ utility or usefulness for which customers will pay To be called an innovation, an idea must be replicable at an economic cost and must satisfy a specific need. Innovation involves deliberate application of information, imagination and initiative in deriving greater or different values from resources, and includes all processes by which new ideas are generated and converted into useful products”.
  17. 17. 16/4/2014RD_UOK_April-201417 How do we innovate? We use our Intellect to do so! Those who innovate may become entrepreneurs.
  18. 18. 16/4/2014RD_UOK_April-2014 18 Proof of Concept Legal Protection ValidationIn house Experimental Production MARKET SALES Components of Technology Management Clinical Trials/Field Trials
  19. 19. Innovation & Enterprise Individuals/ Universities/ Key Players Institutes/ Industries Invention/ Technology Investment Enterprise/Start up Company Royalty Reap the Fruits of Innovation if the product is commercialized 16/4/2014RD_UOK_April-2014 19 Contribution to Economy IP Protection/ Patents
  20. 20. How do we generate Intellectual Property? Research Legal Protection/Patent 16/4/2014RD_UOK_April-2014 Practical leads/ PoC/ Invention/Product File a Patent/ License the Technology; or Sell Technology Develop & Manufacture Product (commercial activity) Company/ Enterprise 20 Entrepreneurship
  21. 21. Innovators desire or demand:  Legal protection for innovations;  Compensation + Awards to keep their innovative spirit going Governments of various countries agreed to do the needful Net Result: These regulations keep the “fire in the genius going” 16/4/2014 RD_UOK_April-2014 21
  22. 22. Idea/Technology (Business preposition) Start-up Company & Execute (Players, Team, Fund-raising, IP; know your roles & profit sharing) Create Products (Players, Team, Fund-raising, IP; know your roles & profit sharing) Grow as an Entrepreneur 16/4/2014RD_UOK_April-201422
  23. 23. 16/4/2014RD_UOK_April-201423 Innovations should be:  Purposeful  Affordable  Useful for an individual or society  Easy to use  Safe to use  Easy to manufacture Approved by Society  Should have component of Corporate Social responsibility
  24. 24. Unaffordable Price: At $28,000 a Vial, Questcor Finds Profits?? An anti-inflammatory drug called H.P. Acthar Gel, used for treatment of gout back in the early 1990s, and developed in the 1950s by a division of Armour & Company, the meatpacking company that once ruled the Union Stock Yards of Chicago. As in the 1950s, Acthar is still extracted from the pituitary glands of slaughtered pigs — essentially a by-product of the meatpacking industry. Acthar is used to treat infantile spasms, also known as West syndrome, a rare, sometimes fatal epileptic disorder that generally strikes before the age of 1. In 2007, it raised the price overnight, to more than $23,000 a vial, from $1,650, bringing the cost of a typical course of treatment for infantile spasms to above $100,000. It said it needed the high price to keep the drug on the market. 16/4/2014RD_UOK_April-201424
  25. 25. Inventions or Products; & Type of Legal Protection: Products Legal Protection  Glivec, Immuvac, Humira mAb, Samsung Galaxy Gene Sequencers, PCR machine, Pandylfu : Patents Nescafe; GloFish***/ARTSK_NII/ Prozac/ Tylenol : Trade Mark  Maruti, Honda Model XX : Design Registration Internet Explorer, Gene Sequences & Music : Copyright  Coke, Techniques to generate enzymes : Trade Secrets  Traditional Knowledge & New Plant Varieties  South Indian Silk sarees/ Bengal cotton cloth/Bikaji Bhujia : Geographical Indicators (***The GloFish is a trademarked transgenic zebrafish (Danio rerio) expressing a red fluorescent protein from a sea anemone under the transcriptional control of the promoter from the myosin light peptide-2 gene of zebrafish1. Produced and patented by a group at the National University of Singapore) 16/4/2014RD_UOK_April-2014 25
  26. 26. 16/4/2014RD_UOK_April-201426 Technology Management Process
  27. 27. 16/4/2014RD_UOK_April-2014 27 Invention Disclose Invention to Patent Office Review & Approval Protect Intellectual Property (Patent)/Grant Find Potential Licensee/Industrial Partner NDA/CDA/ License Upscale/Prototype/Clincal or Field Trials Production/ Marketing & Commercialization Royalties TechnologyManagementProcess
  28. 28. 16/4/2014RD_UOK_April-2014 28
  29. 29. 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-up Company 5. MoUs_NDA : TTO or Attorney or Agencies 6. Licence , DA : TTO or Attorney 7. Exchange Know-how_MoUs : You and Industry 8. Demand Signing Amount : You + University 9. Furnish Data (Importance of Record Book): You + Industry 10. Freedom to Operate Analysis : TTO/ Patent Attorney 11. Industrial Partner will Validate Data>Upscale>Pilot run 12. Milestone Payments : You + University 13. Industry will Manufacture, Commercialize, Market Product 14. Distribution of Royalty on Sales : You + University + Industry 16/4/2014RD_UOK_April-201429
  30. 30. 16/4/2014RD_UOK_April-201430
  31. 31. Inventions or Products & Type of Legal Protection: Products Legal Protection  Glivec, Immuvac, Humira mAb, Samsung Galaxy Gene Sequencers, PCR machine,Pandylfu : Patents Nescafe; GloFish***/ARTSK_NII/ Prozac/ Tylenol : Trade Mark  Maruti, Honda Model XX : Design Registration Internet Explorer, Gene Sequences & Music : Copyright  Coke, Techniques to generate enzymes : Trade Secrets  Traditional Knowledge & New Plant Varieties  South Indian Silk sarees/ Bengal cotton cloth/Bikaji Bhujia : Geographical Indicators (***The GloFish is a trademarked transgenic zebrafish (Danio rerio) expressing a red fluorescent protein from a sea anemone under the transcriptional control of the promoter from the myosin light peptide-2 gene of zebrafish1. Produced and patented by a group at the National University of Singapore) 16/4/2014RD_UOK_April-2014 31
  32. 32. 16/4/2014RD_UOK_April-201432 Human Creativity in Front Line Areas Rigorous Experimentation Laboratories, under Controlled Conditions Clinical or Field Trials Credit assigned to: (a) Organization, University or Laboratory (b) Inventor or Innovator
  33. 33. 16/4/2014RD_UOK_April-201433 Relationship between Innovation, Basic Science, Economy & IPR
  34. 34. Basic Sciences Research Fundamental Discoveries & Inventions Solutions=Commercially Relevant Applications or Products RoleofVariousPlayers (FundingAgencies/Collaborators/ Consortia) 16/4/2014RD_UOK_April-2014 34 CycleofEconomy
  35. 35. Basic Sciences Research Fundamental Discoveries/ Inventions Solutions=Commercially Relevant Applications or Products RoleofVariousPlayers) (FundingAgency/Collaborators/ Consortia) 16/4/2014RD_UOK_April-2014 35 CycleofEconomy ProtectionofIntellectualProperty (Patents/TM/Copyrightsetc)
  36. 36. 16/4/2014RD_UOK_April-201436 IPR & Entrepreneurship- Essentials • Highly competitive Subject • Be open minded & helpful • Learn to act in a team • Be pleasant • Participate in discussions • Learn to face stresses • Learn to respond to a change • Never be biased • Analyze facts (Trust-but-Verify) • Accept failures or mistakes • All of the above is linked to Entrepreneurship
  37. 37. 16/4/2014RD_UOK_April-201437 Innovation Ecosystem & Patent Laws
  38. 38. 16/4/2014 RD_UOK_April-2014 38 IP Protection 1 2 3 4 6 7 5
  39. 39. 16/4/2014RD_UOK_April-201439 IP Protection
  40. 40. 16/4/2014RD_UOK_April-201440 ( Indian Patent Act, 1970, 1972, 2005, 2006…..) 2[(ii] viii) in relation to any other State, the High Court for that State; 1."invention" means any new and useful- 2. art, process, method or manner of manufacture; and includes any new and useful improvement of any of them, and an alleged invention; 1."legal representative" means a person who in law represents the estate of a deceased person; 1. "medicine or drug" includes- 2. all medicines for internal or external use of human beings or animals, 3. all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of diseases in human beings or animals, 1. all substances intended to be used or in the maintenance of public health, or the prevention or control of any epidemic disease among human beings or animals, 1. insecticides, germicides, fungicides, weedicides and all other substances intended to be used for the protection or preservation of plants, 1. all chemical substances which are ordinarily used as intermediates in the preparation or manufacture of any of the medicines or substances above referred to; (Source: http://ipindia.nic.in/ipr/patent/patact1970-3-99.html)
  41. 41. 16/4/2014RD_UOK_April-201441 Indian Patent Laws (Biotech) Sec 2 (1) (j): Inventions (novelty, inventive steps & industrial applications) Sec 10(4)(d): Mandatory deposition of biological (A) to (D) Materials in IDA & disclosing date & number of deposit at Institution with proper characterization
  42. 42. 16/4/2014RD_UOK_April-201442 Exclusions of Patenting Biotechnological inventions in India Sec 3(b) : Morality/ethical issues Sec 3(c) : Scientific principles, natural living/ non-living Sec 3(d) : Mere discovery of known substance Sec 3(e) : Mere admixture Sec 3(h) : Agricultural/horticultural methods Sec 3(i) : Method of human/animal treatment Sec 3(j) : Human/animal in whole or parts Sec 3(k) : Computer program Sec 3(p) : Traditional knowledge
  43. 43. 16/4/2014 RD_UOK_April-2014 43 IP Protection 1 2 3 4 6 7 5
  44. 44. 16/4/2014RD_UOK_April-2014 44 Caution: Applicable if the “Product is Great, Easy to Use & Affordable” Dreams
  45. 45. Intellectual Efforts Generate Technologies (i.e. generate IP) 16/4/2014RD_UOK_April-2014 45 Technologies have been generated under two types of Revolutions: (A) Industrial Revolution (B) Knowledge Revolution
  46. 46. 16/4/2014 RD_UOK_April-2014 46 Scientific Eras & Technology Generation Industrial Growth Knowledge Driven Revolution Biotech will touch zenith
  47. 47. 16/4/2014RD_UOK_April-201447 Global Biotechnology Scenario Europe : Knowledge based bio-economy North America : Synthetic Biology Asia/Pacific rim /Latin America : Coming up as powerful players India : Attempting to do all of above Africa : Lags behind [Source: Current Opinions in Biotechnology, 23:827-829 (2012)]
  48. 48. 16/4/2014RD_UOK_April-201448 What We Need? Innovations need platforms as they are emerging in the world’s most advanced countries, and India has the potential to capitalize on this platform as well. In fact, our performance to date has been low. Nonetheless, we observe a gradual change. Our innovative_commercialization record has been weak; we have a limited ability to harness risk capital; we have a shortage of critical, highly skilled talent; and our slow regulatory approvals process could limit the pace of development.
  49. 49. 16/4/2014RD_UOK_April-201449 What we essentially need? (J&K) Simple/ Affordable/ Mass utilization/ Incremental Technologies related to silk-worm/ trout farming Technologies to Improve Pashmina Goat breeding Plant propagation/ Highly improved Varieties of Saffron  Micro-prospecting Solutions for T.B./Infectious diseases/ Cancer Biomarkers
  50. 50. 16/4/2014RD_UOK_April-201450 Technologies/ Solutions Societal Relevance/Simple solutions or technologies Incremental Disruptive Futuristic Business Impact
  51. 51. 16/4/2014 RD_UOK_April-2014 51 Inventions/Technologies From Social angle (Social Impact) Social : (=cheap, easy to use; “Jugaad”?) From Scientific angle (Technical Impact) Incremental: (=small but useful innovations) Disruptive : (=great path-breaking inventions) Futuristic : (=as used by space agencies) From Business Angle (Business Impact) Sustenance of economy
  52. 52. 16/4/2014RD_UOK_April-201452 StagesofTechnologyLifeCycle RPV=Remotely Piloted Vehicle
  53. 53. 16/4/2014RD_UOK_April-2014 53 [www.] Disruptive Technologies
  54. 54. www: Our Constant Companion 16/4/2014RD_UOK_April-2014 54 Imagine World without www at CERN It is the birthplace of the World Wide Web. The main site at Meyrin also has a large computer centre containing very powerful data-processing facilities primarily for experimental data analysis and, to make them available to researchers elsewhere; has historically been a major wide area networking hub. CERN's main function is to provide the particle accelerators and other infrastructure needed for high-energy physics research. Numerous experiments have been constructed at CERN by international collaborations to make use of them.
  55. 55. 16/4/2014RD_UOK_April-201455 Oxford Nanopore Technologies Ltd. is entering the gene-sequencing race with a new portable device to analyze DNA on the go. The product, called MinION, is about the size of a USB memory stick, the closely held Oxford, England-based company said today. MinION will be ready for sale in the second half of the year at a cost of less than $900. It’s a smaller version of the GridION device that Oxford Nanopore is developing.
  56. 56. 16/4/2014RD_UOK_April-201456 Chemical Shield on Clothes and Fatigues Clothes impervious to Coffee Stains and Biological agents By a process called as Electro-spinning U.S. Airforce + University of Michigan (Source: J. American Chemical Society 13.2.2013)
  57. 57. 16/4/2014RD_UOK_April-201457 ASIA
  58. 58. Threatened Medicinal Plant Species in Asia Mishimi teeta (Coptis teeta) (anti-inflammatory & anti-bacterial). Chirata (Swertia chirayita: anti-Hepatitis-B activity) have highly localized ecological jurisdiction in the high altitude regions of Eastern Himalaya. Sarpangadha (Rauvolfia serpentina:anti-hypertensive & anti-Schizopherinia) is another promising species of NE India, but over-exploitation of the species from wild habitat has obstructed the popularization of the species as commercially cultivable crop 16/4/2014RD_UOK_April-201458
  59. 59. "Shockwave technology could be applied to the tea processing unit to help kill major pests, prepare land for cultivation, minimise overall time of withering and other costs in the tea factories“ A similar mechanism could be developed to treat pests in orchards in Kashmir Source: IISc Bangalore 16/4/2014RD_UOK_April-201459
  60. 60. The invention of monel valves and their use in the industry The use of monel valves has increased over the past decade as a measure to combat corrosive and unfriedly industrial environments. Monel K500, Monel 400, A494 MR-35-1 are often used in HF Acid applications. The alloy used in Monel valves was developed in the 1920s, the alloy is still known as Monel alloy K-500 (http://www.super-duplex-valves.com). 16/4/2014RD_UOK_April-201460
  61. 61. Use of Engineering Plastics for Diagnostic X-ray equipment 16/4/2014RD_UOK_April-201461
  62. 62. U_Mass, Amherst Chemical Engineers Boost Petrochemical Output From Biomass By 40% Chemical engineers at the University of Massachusetts Amherst, using a catalytic fast pyrolysis process that transforms renewable non-food biomass into petrochemicals, have developed a new catalyst that boosts the yield for five key "building blocks of the chemical industry" by 40 percent compared to previous methods. This sustainable production process, which holds the promise of being competitive and compatible with the current petroleum refinery infrastructure, has been tested and proven in a laboratory reactor, using wood as the feedstock, the research team says 16/4/2014RD_UOK_April-201462
  63. 63. Arctic Groundbreaking technologies The two recipients of the 2012 Spotlight on Arctic Technology Award, as it is called, were Texas-based seismic solutions company ION Geophysical's under-ice towed marine streamer and Transkor Group Inc.'s Aqua magnetic tomography method (MTM). ION’s towed marine streamer technology is designed for high latitude operations and is used in a dual-vessel and icebreaker system. The polarclass icebreaker clears a path for the seismic vessel, while the towing system prevents the remaining ice from damaging the cables in tow, keeping them in the water even under wind gusts of over 100 knots. The technology is able to withstand extreme temperatures and pole magnetics, which not only reduces damage to the equipment and to the quality of the data acquired but also extends the traditional season for data acquisition in the Arctic and allows for such acquisition to take place further north. Transkor’s Aqua MTM technology is designed to assess offshore ferromagnetic pipelines and determine the probability of stress-deformed state anomalies. It can inspect the entire length of pipelines and detect pipe sags, strains and twists, boasting a rate of anomaly detection of over 80 per cent. The inspection determines and reports the deviation of a pipe material stress-deformed state and estimates the period of accident free operation 16/4/2014RD_UOK_April-201463
  64. 64. 16/4/2014RD_UOK_April-201464 Health & Medicine
  65. 65. 16/4/2014RD_UOK_April-2014 65 World's First Bionic Eye Approved for Use in Europe [Video] | Fast ... 7 Mar 2011 ... bionic eye Could blindness soon be a thing of the past? A California company called Second Sight recently received approval in Europe to sell ... www.scientificamerican.com/article.cfm?id=steps-owards...bionic... Retina
  66. 66. 16/4/2014RD_UOK_April-201466 13.2.2013 (New York Times) Latest Invention for the Blind from U.S.A : The technique Allows blind to visualize shapes
  67. 67. A Conversation With Nick Goldman Double Helix Serves Double Duty http://www.nytimes.com/2013/01/29/science/using-dna-to-store-digital-information.html?ref=science&_r=0 A group of researchers at the European Bioinformatics Institute reported in the journal Nature that they had managed to store digital information in synthetic DNA molecules, then recreated the original digital files without error. The amount of data, 739 kilobytes all told, is hardly prodigious by today’s microelectronic storage standards: all 154 of Shakespeare’s sonnets, a scientific paper, a color digital photo of the researchers’ laboratory, a 26-second excerpt from the Rev. Dr. Martin Luther King Jr.’s “I have a dream” speech and a software algorithm. Nor is this the first time digital information has been stored in DNA. But the researchers said their new technique, which includes error-correction software, was a step toward a digital archival storage medium of immense scale. Their goal is a system that will safely store the equivalent of one million CDs in a gram of DNA for 10,000 years. 16/4/2014RD_UOK_April-201467
  68. 68. 16/4/2014RD_UOK_April-201468 Metal Hip Implants
  69. 69. 16/4/2014RD_UOK_April-201469 Metal Hip Implants
  70. 70. 16/4/2014RD_UOK_April-2014 70 Microsoft and the University of Washington are developing an electronic contact lens that can non-invasively monitor and wirelessly report blood sugar levels (Jan 5, 2012)
  71. 71. New Drug for Treatment of Tuberculosis 31.12.2012 (N.Y. Times) A new drug, to be called Sirturo, was discovered by scientists at Janssen, the pharmaceuticals unit of Johnson & Johnson, and is the first in a new class of drugs that aims to treat the drug-resistant strain of the disease, has been approved by FDA. (Dr. Anil Kaul of J&J) “This is quite a milestone in the story of therapy for TB,” Dr. Paul Stoffels, the chief scientific officer at Johnson & Johnson, said in an interview. He said the approval was the first time in 40 years that the agency had approved a drug that attacked tuberculosis in a different way from the current treatments on the market. Sirturo works by inhibiting an enzyme needed by the tuberculosis bacteria to replicate and spread throughout the body. 16/4/2014RD_UOK_April-201471
  72. 72. 16/4/2014RD_UOK_April-201472 FDA approves test that detects 11 causes of infectious gastroenteritis from single sample January 16, 2013 The xTAG Gastrointestinal Pathogen Panel (GPP), manufactured by Luminex, detects 11 viral, bacterial and parasitic causes of gastroenteritis, including Clostridium difficile toxin A/B, Escherichia coli O157, Salmonella, Shigella, norovirus, rotavirus A, Cryptosporidium and giardia. It is the first test capable of simultaneously detecting each factor from a single sample. Approval for xTAG GPP followed results of a study comparing its efficacy with that of individual tests that detected each cause of gastroenteritis, incorporating data from 1,407 adult patients and 313 pediatric patients with suspected infectious gastroenteritis, as well as 203 patients with confirmed gastroenteritis. The xTAG GPP performed comparably to individual tests. “The test could also allow clinicians and public health professionals to more quickly identify and investigate the source of potential gastroenteritis outbreaks.”
  73. 73. Merck tests needle-free vaccines •Suzanne Elvidge Journal name: Nature Biotechnology; Volume: 30,, Page: 1155, Year published: (2012); DOI: doi:10.1038/nbt1212-1155a, Published online , 07 December 2012 In October, 2012, the Whitehouse Station, New Jersey–based Merck agreed to license a novel vaccine delivery system from Sydney, Australia–based biotech Vaxxas, for testing with an undisclosed Merck vaccine candidate. The biotech's Nanopatch, needle-free delivery platform is a densely packed array (>20,000/cm2) of 110-μm-long needles dry-coated with vaccine. The antigens are… 16/4/2014RD_UOK_April-201473
  74. 74. Bacterial shield for seeds Emily Waltz Journal name:Nature BiotechnologyVolume: 30,Page:1158Year published:(2012)DOI:doi:10.1038/nbt1212- 1158aPublished online 07 December 2012 Agribusiness giant Syngenta will pay up to $113 million to acquire Pasteuria Bioscience, a small biotech with a novel natural process to control nematode pests in plants. Under the terms of the agreement, the Basel-based Syngenta giant will acquire Pasteuria for $86 million, with additional deferred payments of up to… 16/4/2014RD_UOK_April-201474
  75. 75. Hand held Ultrasonic machine 16/4/2014RD_UOK_April-201475
  76. 76. Diagnosing Malaria with one drop of body fluid Researchers from the Aarhus University in Denmark have developed a new test to diagnose malaria infections very quickly and with a high sensitivity. The test measures the activity of the enzyme topo-isomerase-I from the Plasmodium parasite, which causes malaria. The new method is based on a technology which the researchers call Rolling Circle Enhanced Enzyme Activity Detection (REEAD). This method is able to diagnose malaria infection with just a single drop of blood or saliva, and on top of that it has high sensitivity and no special training is required to perform the test. Other features of the REEAD method are the ability to detect the infection of less common malaria parasites and measure whether the Plasmodium infection is resistant to drugs. 16/4/2014RD_UOK_April-201476
  77. 77. Singapore based Veredus Laboratories announced the launch of its VereMTB multiplexed lab-on-a-chip for the detection of various mutations of Mycobacterium responsible for causing tuberculosis as well as nine other similar clinically interesting mycobacterium. The chip identifies the specific mycobacterium within three (3) hours after being presented with a sample of coughed up direct sputum. The technology doesn’t require culturing the bacteria, a slow process that can extend into days when rapid detection is key. Veredus VereMTB Chip for Fast Diagnosis of TB by Gene Ostrovsky on Nov 9, 2012 16/4/2014RD_UOK_April-201477
  78. 78. Tumor-Fighting Immune Cells to Attack Cancer (Researchers at UCLA’s Jonsson Comprehensive Cancer Center have created a large, well-armed troop of tumor-seeking immune system cells to locate and attack dangerous melanomas) 16/4/2014RD_UOK_April-201478
  79. 79. 16/4/2014RD_UOK_April-201479 Incremental Innovations
  80. 80. Oil-Eating Bacteria to Clean up Oil Spills That certain bacteria have the ability to metabolize oil isn’t a new discovery of course. Back in 1989, bacteria were used experimentally in attempts to clean up the 11 million gallons of crude oil spilled by the Exxon Valdez after it ran aground off the coast of Alaska. Though it made little to no difference back then, now that researchers have a complete blueprint for the oil- hungry bacteria: Alcanivorax borkumensis, they’ll have the ability to optimize the conditions for these bugs, enabling them to soak up the hundreds of millions of liters of oil that enter our waters each year 16/4/2014RD_UOK_April-201480
  81. 81. Engineered Tobacco Plants as Biofuel The challenge researchers faced was that this precious oil is mostly found in tobacco seeds, and tobacco plants only produce about 600 kg of seeds per acre. However, they have now found ways to genetically engineer the plants so that their leaves express more oil. According to one of the project’s researchers, Dr. Andrianov, they have been able to modify plants to produce 20-fold more oil in the leaves. Andrianov says “”Based on these data, tobacco represents an attractive and promising ‘energy plant’ platform, and could also serve as a model for the utilization of other high- biomass plants for biofuel production.” 16/4/2014RD_UOK_April-201481
  82. 82. Stem cell culturing without the use of animal substances (in a completely chemically-defined environment) 16/4/2014RD_UOK_April-201482
  83. 83. 16/4/2014RD_UOK_April-201483 Innovations Having Immediate Social Impact Improved/ Affordable versions of B.P machine Cycle rickshaw with a small engine Bag containing Tea leaves with a thin (painful) or thick handle (comfortable) Dhara oil pack with an easy to remove seal Table fork with a knife on edge  Drug eluting stent  Airport Baggage Handling on Ground  Honey manufacturing from Apiaries
  84. 84. 16/4/2014RD_UOK_April-201484 Innovations Having Social Impact Evolution of Camera
  85. 85. 16/4/2014RD_UOK_April-201485 Conclusion
  86. 86. 16/4/2014RD_UOK_April-201486 S. N o. Status of Technology Method of Disposal Outcome 1. Societal/ Jugaad Short tem life, but useful in daily life – should be used due to cheap price, but safety precautions be considered. Maternal & child health, Rickshaws, pens etc. Useful 2. Disruptive Great use, great products, long life, really change the world e.g., Cell phone, PCR, Vaccine, Pen drive sized Gene Sequencers, Microwave for cancer cure, Space-crafts V.V. Useful 3. Incremental Sustains Disruptive or incremental innovation, very useful: new models of Phone or pressure cookers, microwaves Fairly useful/ maintenance) 4. Futuristic Concept of Cell phone was futuristic in 1960-70s; Cloud computing for war or navigation is useful today; keep under wraps for future use Very thoughtful 5. Great Business Model for any of the above Shampoo sachet, small packs of tooth paste. Tata Nano had a bad business model/ Colgate tooth paste had great business model (Necessary for money generation; No one works for charity)
  87. 87. 16/4/2014RD_UOK_April-201487 Take a Break, Relax & Look at this!
  88. 88. 16/4/2014RD_UOK_April-201488
  89. 89. 16/4/2014RD_UOK_April-201489 Technology Addiction
  90. 90. “I fear the day when technology overlaps with our humanity. The world will only have a generation of idiots." – Albert Einstein 16/4/2014RD_UOK_April-201490
  91. 91. 16/4/2014RD_UOK_April-201491 “Everything should be made as simple as possible, but no simpler.” Only a handful, however, have had the opportunity to discuss the concept with the physicist over breakfast. As an applied- mathematics student at Harvard, Dr. Neumann had a two-hour breakfast with Einstein on Nov. 8, 1952. What the young math student took away was a deeply held philosophy of design that has remained with him for six decades and has been his governing principle of computing and computer security. “His biggest contribution is to stress the ‘systems’ nature of the security and reliability problems,” said Steven M. Bellovin, chief technology officer of the Federal Trade Commission. “That is, trouble occurs not because of one failure, but because of the way many different pieces interact.”
  92. 92. What is Intellectual Property? Def. 16/4/2014RD_UOK_April-2014 92  Classical Definition: “A mental or intellectual activity” which results in a useful Technology related to an industrial design or a machine comprises Industrial Property (=IP).  IP is generated by Inventors or Innovators****  Over years this term evolved into Intellectual Property which includes Patents, Copyright, Trade Mark, Trade Secrets, Geographical Indicators, Protection of Plant Varieties etc.
  93. 93. Forms of Intellectual Property 16/4/2014RD_UOK_April-2014 93  Property: Tangible (which can be seen)  House, Expressway Road  a commercial activity Non-tangible (which can not be described as such)  Vaccine  Computer chip  a commercial activity
  94. 94. Innovators desire:  Legal protection of innovations;  Compensation + Awards to keep their innovative spirit going Governments of various countries agreed to do the needful Net Result: These regulations keep the “fire in the genius going” 16/4/2014 RD_UOK_April-2014 94
  95. 95. Innovation Index Issues? 16/4/2014RD_UOK_April-2014 95  Innovation Index for us?  Our Issues  Can we innovate alone?  Do we need to innovate alone? Current Economic Scenario in the world necessitates us to join hands ; & draw more out of less
  96. 96. 16/4/2014RD_UOK_April-201496 Top 10 in the Global Innovation Efficiency Index •China •India •Republic of Moldova •Malta •Switzerland •Paraguay •Serbia •Estonia •Netherlands •Sri Lanka (source: WIPO)
  97. 97. 16/4/2014RD_UOK_April-201497 Group-1 Group-2 Group-3
  98. 98. Why IP Rights are Necessary! 16/4/2014RD_UOK_April-2014 98 Creation of IP needs financial support  IP Rights boost innovation by protecting the :interest of inventor  IP generates :revenue  IP results in :commerce  Commerce is :trans-continental  Commerce is :regulated  Commercial :practices should be uniform for healthy business ethics (WTO + WIPO)
  99. 99. 16/4/2014 RD_UOK_April-2014 99 Incentives from Property Ownership are Deeply Rooted in Law (John Locke (1632-1704)– Father of Liberalism) John Locke uses the word property in both broad and narrow senses. In a broad sense, it covers a wide range of human interests and aspirations; more narrowly, it refers to material goods. He argues that property is a natural right and it is derived from labour. Locke believed that ownership of property is created by the application of labour. In addition, property precedes government and government cannot "dispose of the estates of the subjects arbitrarily." Karl Marx later critiqued Locke's theory of property in his social theory.
  100. 100. 16/4/2014RD_UOK_April-2014 100
  101. 101. Evolution & Historical Perspective  Technology development in India & elsewhere: Historical perspective  Protection of Creative Glass Blower’s Art in Italy, 1449  USA: Patent protection initiated by President Jefferson (1793) (http://www.earlyamerica.com/review/winter2000/jefferson.html)  India : Extension of British Patent Laws- Act VI of 1856  In India, during British era : modifications in British Labor Laws to protect dissemination of technology related information to others (1942)  Patent Laws of India – Post Independence (1970, 2005) 16/4/2014RD_UOK_April-2014 101
  102. 102. Industrial Property Rights Systems 16/4/2014RD_UOK_April-2014 102 IPRS encourages the talented inventors (=creators/innovators) to further industrial development Research & Investment Essential Requirements/ Life Comforts
  103. 103. 16/4/2014 RD_UOK_April-2014 103 Technology Generation Industrial Revolution Knowledge Driven Revolution Ramifications of Biotechnology Will Touch Zenith in future
  104. 104. 16/4/2014RD_UOK_April-2014 104  Intellectual Property Rights (WIPO Classification)  (A) Copyright and rights related to copyright  (B) Industrial property:  (1) trademarks and geographical indications  (2) industrial designs (protected by patents), and  (3) trade secrets.  What are “intellectual property rights”? Intellectual property rights can be defined as the rights given to people over the creations of their minds. They usually give the creator an exclusive right over the use of his/her creations for a certain period of time.
  105. 105. Salient Features of IP 16/4/2014RD_UOK_April-2014 105  IP shares many characteristics associated with real and personal property  IP is an asset – it can be bought, sold, licensed, exchanged or given away like any other form of property; but Indian Banks do not give loans?  IP owner has the right to prevent unauthorized use or sale of property  However, IP is intangible (it can’t be defined)
  106. 106. Intellectual Property : A Complex & Serious Subject Science & Technology IPR, Patent Laws Commerce International Trade Relations Business Development & Networking Negotiation Skills Economics Accounting Public Opinion Ethics (Anybody who works in this area needs a flexible attitude) 16/4/2014RD_UOK_April-2014 106
  107. 107. Creativity i.e., Innovation results in IP 16/4/2014RD_UOK_April-2014 107  Innovation generates Intellectual Property  Intellectual Property in Biotech Sector is generated through rigorous experimentation but is more complex  Innovation changes life styles e.g., tele-medicine by use of mobile phones/ pacemaker/ vaccine/ recombinant crop
  108. 108. Relevance of Technologies in Current Global Scenario in Biotech sector Requirement of people friendly technologies for health care/ Agriculture/Environment/Fuels etc Growth of biotech institutes  Increase in number of skilled & semi-skilled people  Increase in international & national collaborations 16/4/2014RD_UOK_April-2014 108
  109. 109. 16/4/2014RD_UOK_April-2014 109 Current Advantages • Robust economical scenario****** • Promising potential to be a global player in the arena of biotechnology • Large pool of skilled and cost competitive manpower • Well developed and integrated scientific infrastructure • Advanced chemical synthesis technologies • Manufacturing practices conforming to US and EU norms • Diverse biological resources • Globally recognized as a producer of low cost, high quality bulk drugs and formulations.
  110. 110. 16/4/2014RD_UOK_April-2014110 Funding for Innovative Research in Biotech Sector ---GoI Effort & Evolution of BIRAC---
  111. 111. Funding Support (loans or grants) in INR BIG SIBRI BIPP CRS BISS & UIC 50 Lacs 2 Cr 50 Cr > Case to case Case to case National Biotechnology Policy 16/4/2014 RD_UOK_April-2014 111 Source: BIRAC website (modified)
  112. 112. Why Technologies? Is Change Useful! S. No. Old Technology New Technology 1. Test Tube Eppendorf Tube 2. Petri Dish Tissue Culture Flask 3. External Pace maker Implantable Pace Maker 4. Mercury Column B.P. measuring machine Digital B.P. machine 5. Drugs Target Specific Drugs 6. ELIZA tests PCR amplified Tests High level of Technology : Higher Royalty or Prices 16/4/2014 RD_UOK_April-2014 112 This makes life more comfortable!!!
  113. 113. 16/4/2014RD_UOK_April-2014 113 Technology Sectors & Investment Opportunities •Agriculture and Plant Biotechnology •Medicinal and Aromatic plants •Animal Biotechnology •Aquaculture and Marine Biotechnology •Seri biotechnology •Stem Cell Biology •Human Genetics and Genome Analysis •Environmental Biotechnology •Microbial and Industrial Biotechnology •Healthcare •Bio-Fuels •Bio Pesticides •Bio-Informatics •Software Support •Mechatronics
  114. 114. Legal Protection to Human Creativity !  Patents : Glivec, Immuvac, Humira mAb, Pandylfu  Trade Mark : Nescafe; GloFish***/ ARTSK_NII/Prozac/Tylenol  Design Registration : Honda Model XX  Copyright : Internet Explorer, Gene Sequences & Music  Trade Secrets : Coke, Techniques to generate enzymes  Traditional Knowledge & Protection of New Plant Varieties  Geographical Indicators : South Indian Silk sarees/ Bengal cotton cloth (***The GloFish is a trademarked transgenic zebrafish (Danio rerio) expressing a red fluorescent protein from a sea anemone under the transcriptional control of the promoter from the myosin light peptide-2 gene of zebrafish1. Produced and patented by a group at the National University of Singapore) 16/4/2014RD_UOK_April-2014 114
  115. 115. Examples of IP Protection: 16/4/2014 115 RD_UOK_April-2014
  116. 116. 16/4/2014RD_UOK_April-2014116 PATENTS
  117. 117. Patents? 16/4/2014RD_UOK_April-2014 117 PATENT: may be granted for a new (novel), non- obvious (having inventive step), and useful (having utility) invention It gives the patent holder a right to prevent others from practicing the invention (unless licensed by the inventor), for a certain period of time (typically 20 years from the filing date of a patent application).
  118. 118. What are the Parts of a Patent? 16/4/2014RD_UOK_April-2014 118  Abstract  Background of the Invention  Summary of the Invention  Figures with brief descriptions  Detailed description or “specification”  Fully discloses what the invention is  How it is made?  How it can be used?  Claim(s): sets the legal boundaries of protection  Independent  Dependent
  119. 119. 16/4/2014RD_UOK_April-2014 119 Step 1: Prior Art as home work?
  120. 120. Pace Maker Drug Eluting Stent 16/4/2014 RD_UOK_April-2014 120
  121. 121. Medication Pore to release drug into blood vessel Blood Vessel 16/4/2014 RD_UOK_April-2014 121
  122. 122. A Vaccine 16/4/2014 RD_UOK_April-2014 122
  123. 123. 16/4/2014RD_UOK_April-2014123 PANDYFLU vaccine DBT-BIRAC Supported Product - 2011
  124. 124. 16/4/2014 RD_UOK_April-2014 124
  125. 125. GloFish®™ 16/4/2014 RD_UOK_April-2014 125
  126. 126. Patents & IP Protection of our Works “Patent protection does not result in owning the invention by the inventor but protects, others from repeating the effort which has already been made” Characteristics of a Patent : Novelty : (=something new & different) Inventive Step : (=non-obviousness) Industrial Application : (=utility) A patent has a life : 20 years It has to be renewed periodically by payment of money “ Patent System Adds fuel to interest to the fire of the genius”  Ref. to Indian Patent Laws !! 16/4/2014RD_UOK_April-2014 126
  127. 127. Examples: Patents 16/4/2014RD_UOK_April-2014 127  Pandyflu vaccine : (anti-flu vaccine: Panacea + BIRAC)  Immuvac : (anti-leprosy vaccine/immunomodulator: Cadila)  ARTSK_NII : (artificial wound healing membrane: NII)  Paracetamol : (pain killer)  Therapeutic Antibodies : (Humira)(auto-immune disorders)  Recombinant Banana?? (QUT + BIRAC)  Recombinant Cotton : (Textiles: Monsanto)  Straw Water Purifiers : (US Army)  K-Series Engine : (Motor Car)
  128. 128. 16/4/2014RD_UOK_April-2014128 Novelty
  129. 129. 1 2 3 4 Protein Adjuvant Vaccine Cough Syrup Excepients Cough Syrup Perishable 16/4/2014RD_UOK_April-2014129 A B C
  130. 130. 1 2 3 4 Protein Adjuvant + Thimerosal Vaccine Cough Syrup Excepients Cough Syrup with 12 months shelf life 16/4/2014RD_UOK_April-2014130 A B C
  131. 131. 16/4/2014RD_UOK_April-2014131 Obviousness
  132. 132. Obviousness 16/4/2014RD_UOK_April-2014 132  Obviousness, means that “a person having ordinary skill in the art” would not know how to solve the problem at which the invention is directed by using exactly the same mechanism.  The obviousness standard prevents the patenting of relatively insignificant differences between the invention and the prior art  The invention must provide one or more new and unexpected results
  133. 133. Test tube vs Eppendorf tubes Round bottom is Novelty (1840-50) Non-obvious Round pointed bottom is Novelty? 16/4/2014RD_UOK_April-2014133
  134. 134. Tissue Culture Flasks 16/4/2014RD_UOK_April-2014134
  135. 135. Vaccine: Antibody (a protein or peptide) + Adjuvant (binds Ab to target) + Antifungal (Thimerosal) + Envelope-hypothetical (that can not be digested by enzymes) 16/4/2014RD_UOK_April-2014135
  136. 136. Obviousness (contd) 16/4/2014RD_UOK_April-2014 136  Prior art can be combined in an obviousness determination, that is, more than one reference can be cited by the examiner as showing different features of the invention which, taken together, render the invention obvious  Obviousness is inherently a subjective determination, as the examiner cannot be, or know the mind of, the hypothetical “one skilled in the art.”
  137. 137. Non-obvious to Whom? 16/4/2014RD_UOK_April-2014 137  A patent will NOT be issued if a person having ordinary skill in the field of the invention would consider the invention obvious at the time of creation  The law considers a person having ordinary skill in the art to be a worker in the field of the invention who:  Has ordinary skill  Is totally knowledgeable about all the prior art in his or her field  Pure Fantasy, but no other realistic way to determine non- obviousness  The PTO creates a hypothetical person and tries to weigh the obviousness of the invention against the knowledge this hypothetical person would possess
  138. 138. Examples of Obviousness 16/4/2014RD_UOK_April-2014 138  Non-obvious: Slight Physical Changes – Dramatic Result  Sometimes, a very slight change in shape, slope, size, or material can produce a patentable invention that operates entirely differently and produces totally unexpected results  Non-obvious: New Use Inventions  Do not involve any physical change to old invention  Must be different use of known product or process and produce new, unexpected results  Obvious: Different Element, Similar Function  Courts have held that substituting a different, but similarly functioning, element for one of the elements in a known combination creates a novel invention but an obvious one.
  139. 139. Examples of Obviousness (contd) 16/4/2014RD_UOK_April-2014 139  Obvious: Old Concept, New Form  The PTO will consider as obvious the mere carrying forward of an old concept, or a change in form and degree, without a new result (notches on inner rim of steering wheel for better grip, obvious because of medieval sword handles)  Obvious: Duplication of Parts  Usually consider the duplication of a part as obvious unless new results can be observed  Obvious: Portability, Size, Speed, and Integration  Making devices portable, making parts smaller or larger, faster or slower, making elements adjustable, parts integral, separable, etc. will be considered obvious unless new, unexpected results can be shown
  140. 140. Rationale Examples 16/4/2014RD_UOK_April-2014 140 The following examples will demonstrate the appropriate fact findings to support rationales suggested for Company “A” and provide an explanation of how the rationales lead to a conclusion of obviousness under 35 USC 103.
  141. 141. USE OF KNOWN TECHNIQUES TO IMPROVE SIMILAR DEVICES IN THE SAME WAY We claim: A cholesteric color filter comprising: A barrier coating formed on a cholesteric filter layer, said barrier layer preventing oxidation of the filter. 16/4/2014 RD_UOK_April-2014 141 Substrate Substrate Liquid Crystal Layer Barrier Coating Cholesteric Filter Layer Cholesteric Color Filter Adapted from Application No. 10/191,445
  142. 142. USE OF KNOWN TECHNIQUES TO IMPROVE SIMILAR DEVICES IN THE SAME WAY Reference B teaches applying a barrier coating 78 to a color filter 86 to prevent oxidation of the color filter. 16/4/2014 RD_UOK_April-2014 142 Reference A teaches a cholesteric color filter having a layer 200 of material having a cholesteric order and known to have a problem with oxidization.
  143. 143. USE OF KNOWN TECHNIQUES TO IMPROVE SIMILAR DEVICES IN THE SAME WAY 16/4/2014 RD_UOK_April-2014 143 • The prior art references teach all of the claimed elements. • The difference between the prior art and the claimed invention is the use of a barrier coating to prevent oxidation in a cholesteric color filter. • The prior art shows adding a barrier coating to a color filter to prevent oxidation. Applying This Rationale:
  144. 144. 16/4/2014RD_UOK_April-2014144 Disruptive Technologies are an outcome of Convergence of Technologies
  145. 145. Convergence of Technologies Systems at Molecular Level Self Replicating Biological Processes Self Assembly Intelligent, Evolvable, Adaptive System Biotechnology Nanotechnology Information Technology (Source: National Science Foundation, USA, 2006; modified) Future unknown Technologies ? ForHumanUse 16/4/2014RD_UOK_April-2014 145 Green technology
  146. 146. Technology Management &Transfer 16/4/2014RD_UOK_April-2014 146
  147. 147. 16/4/2014RD_UOK_April-2014 147 Proof of Concept Legal Protection ValidationIn house Experimental Production MARKET SALES Components of Technology Management Clinical Trials/Field Trials
  148. 148. Technology Transfer Process Technology (A Vaccine/Therapeutic Agent/GM Crop 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 & Commercialization Revenue & Monitoring (http://www.nii.res.in/faculty-06/RaviDhar.htm) 16/4/2014RD_UOK_April-2014 148 University/ Institute/ Organization Start-up Company /Entrepreneur or a Big Company
  149. 149. 16/4/2014RD_UOK_April-2014 149
  150. 150. 16/4/2014RD_UOK_April-2014 150 Main Stages of Product Development Activity: 1) Idea Generation 2) Idea Screening 3) Concept Development and Testing 4) Business Analysis 5) Beta Testing or Market Testing 6) Technical Implementation 7) Commercialization
  151. 151. 16/4/2014RD_UOK_April-2014 151 Management : Product Development The organization of the product development process is a key success factor within the organization of large manufacturers. Key issues are:- •the process of product development •the underlying philosophy, especially platform strategies •the relation and integration of product and process/manufacturing engineering •the involvement of suppliers into the product development process •the responsibility of product development departments within the launch process As a consequence of the increasing demand for higher product development process performance, many - not to say all - OEMs have built their one-site-development centers. The purpose is clear and means co-locating of all involved faculties in one site.
  152. 152. 16/4/2014RD_UOK_April-2014 152 Contract Research Services • Physical and chemical characterization • Formulation development for small and macromolecules • Reverse Engineering • Release and Stability testing • Container/closure selection • Process development • Scale-up and technical transfer to manufacturing • Manufacture for GLP Toxicology support • Extractables and Leachables evaluation • Product life-cycle management • IND, NDA and aNDA support.
  153. 153. Disposal of Technology 16/4/2014RD_UOK_April-2014 153
  154. 154. 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 (on the basis of maturity/market requirement etc)  Upscale  License after Valuation  Production  Monitor  Sales & Royalty 16/4/2014RD_UOK_April-2014 154
  155. 155. Technology Valuation 16/4/2014 RD_UOK_April-2014 155 Acthar Gel for infantile spasms ?
  156. 156. Value Grid mapping of Technology / Product Portfolios 16/4/2014 RD_UOK_April-2014 156
  157. 157. Great Expectations: 16/4/2014RD_UOK_April-2014 157 Biotechnology & Allied Areas (National & International collaborations will play a great role in these areas)
  158. 158. Quality of Science is essential for Technology Development…. 16/4/2014RD_UOK_April-2014 Canada Korea Italy Netherlands Switzerland India Belgium Sweden Russian Federation Poland Australia Brazil Spain United States Germany France China Japan United Kingdom 1998 2008 Canada Korea Italy Netherlands Switzerland India Belgium Sweden Russian Federation. Poland China Japan Australia Brazil Spain United States Germany France United Kingdom Source: OECD (2010) Measuring Innovation: A New Perspective ? ?
  159. 159. 16/4/2014RD_UOK_April-2014159 Improved Quality of Science needs: 1) Big Budgets & Political will 2) Pool of Skilled Manpower 3) Technology Platforms 4) Intense & meaningful Collaborations
  160. 160. Technology Transfer A complex process involving series of well thought of steps: 1. Research 2. Pre-Disclosure 3. Invention Disclosure 4. Assessment 5. Protection 6. Upscale 7. Make a Start-up Company or Use Existing Company 8. Licensing 9. Marketing & Commercialization 10. Revenue Generation 11. Royalty Sharing or Charity? 16/4/2014RD_UOK_April-2014 160
  161. 161. Technology Transfer Process Drugs/Vaccines/GM crops/Bio-processes 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) Commercialization Revenue & Monitoring (http://www.nii.res.in/faculty-06/RaviDhar.htm) 16/4/2014RD_UOK_April-2014 161 Startup Company
  162. 162. 16/4/2014RD_UOK_April-2014 162
  163. 163. 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 16/4/2014RD_UOK_April-2014 163
  164. 164. 16/4/2014 RD_UOK_April-2014 164
  165. 165. 16/4/2014 RD_UOK_April-2014 165 Strike a Balance
  166. 166. !!!Word of Caution !!! 16/4/2014RD_UOK_April-2014 166
  167. 167. 16/4/2014 RD_UOK_April-2014 167 GMCs Raises Ethical/ Social or Religious Issues !
  168. 168. International Trade & Trade Practices 16/4/2014RD_UOK_April-2014 168
  169. 169. IP & International Agreements Various treaties for different components of IPR  Paris Convention for Protection of Industrial Property (1883)  Mother of all IPR harmonization Process. Revised several times; last revision in 1967 followed by an amendment in 1979. Article 30 covers IPR related to Patents etc.; 170 countries  Lisbon Agreement on Geographical indicators (1958)  Patent Cooperation Treaty (PCT), 144 countries (1970, 1984, 1989)  Budapest Treaty for Deposition of Microorganisms (1977) (List in the Gazette of India; Part II; No. 456, New Delhi, May 30, 2003); 50 countries  Community Trademarks (1996) 16/4/2014RD_UOK_April-2014 169
  170. 170. WTO & WIPO 16/4/2014RD_UOK_April-2014 170  Uniform trade practices across nations regulated by WTO. Organization which develops ground-rules for international Commerce & mediates trade disputes.(153 members) (Web Site : www. wto.org)  Uniform IP practices are regulated by WIPO. WIPO is responsible for the promotion of the protection of intellectual property throughout the world through cooperation among States, .... (179 members) (Web Site :www.wipo.int)
  171. 171. TRIPs  TRIPS agreement gives enough room for member countries to balance international obligations w.r.t domestic/national interests  World was more divided before TRIPS  This impeded the international trade & knowledge diffusion  Conflicts around TRIPs 16/4/2014RD_UOK_April-2014 171
  172. 172. TRIPs (Relevant Titles & Parts & Sections) Parts Sec. Articles Content I - 1-8 General Provisions & Basics II - Scope on use of IPR 1 9-14 Copyrights 2 15-21 Trademarks 3 22-24 Protection of Geog. Indicators 4 25-26 Industrial Designs 5 27-34 Patents 6 35-38 Layout designs 7 39 Protection of undisclosed information 8 40 Control Anti-competitive practices III Enforcement of IPR 1-5 41-61 General/ Admn. Procedures/ Criminal Procedures/ IV 62 Acquisition & Maintenance of IPRs & Related Inter-parties procedures V 63-64 Dispute Prevention & Settlement VI 65-67 Transitional Agreements VII 68-73 Institutional Agreements; Final Provisions (Reference example : Part II, Sec. 5, Article 27-34, Patents) 16/4/2014 RD_UOK_April-2014 172
  173. 173. Place of the TRIPS Agreement in the Multilateral Trading System? • One of the fundamental characteristics of the TRIPS Agreement is that it makes protection of intellectual property rights an integral part of the multilateral trading system, as embodied in the WTO. • The TRIPS Agreement is often described as one of the three “pillars” of the WTO, the other two being trade in goods (the traditional domain of the GATT) and trade in services. •That implies that the TRIPS Agreement applies to all WTO members. It also means that the provisions of the agreement are subject to the integrated WTO dispute settlement mechanism which is contained in the Dispute Settlement Understanding (the “Understanding on Rules and Procedures Governing the Settlement of Disputes”). 16/4/2014RD_UOK_April-2014 173
  174. 174. TRIPS 16/4/2014RD_UOK_April-2014 174  The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement administered by the World Trade Organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) regulation as applied to nationals of other WTO Members. It was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994.
  175. 175. TRIPS 16/4/2014RD_UOK_April-2014 175  TRIPS contains requirements that nations' laws must meet for: copyright rights, including the rights of performers, producers of sound recordings and broadcasting organizations; geographical indications, including appellations of origin; industrial designs; integrated circuit layout-designs; patents; monopolies for the developers of new plant varieties; trademarks; trade dress; and undisclosed or confidential information. TRIPS also specifies enforcement procedures, remedies, and dispute resolution procedures.
  176. 176. TRIPS 16/4/2014RD_UOK_April-2014 176  Protection and enforcement of all intellectual property rights shall meet the objectives to contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.
  177. 177. Facts about Innovation Process 16/4/2014RD_UOK_April-2014 177  Innovation should be of societal relevance  Innovation Process is uncertain  Many times it is unpredictable, more-so when related to Biological systems  Innovation process creates new competencies  Knowledge generation depends on a cumulative process that links prior knowledge in the economy  Various factors influence speed of innovation  Scientific discovery & Innovation is deeply linked  Innovation output has weak relationship with market demand
  178. 178. Biotech in India: Parameters 16/4/2014 RD_UOK_April-2014 178
  179. 179. Contributors to Indian Biotech-IP 16/4/2014RD_UOK_April-2014 179  Funding Organizations (DBT/ICMR/ICAR/CSIR/Charitable)  Academic Partners (Public/Private/Industry/Academia/NGOs)  Industry  Private Sector  Technology Acquisition  Within a nation  Between nations
  180. 180. Strengths for Developing Technologies Strengths Quality of Basic Research R& D Personnel Infrastructure Quality of Business Facilitation India Low High Needs Improvement Low U.S.A. V. High V.High Great Great Germany V. Good V. High Great Good Weaknesses Pharma & Chemical Industry Exposure to Entrepreneurs Personnel Mobility Venture Capital Angel Investors Permits/Licenses & Approvals No. of Pilot Plants High/Ranbaxy Problem? Lack experience Very Low V.Few None Slow Process Lack of Proof +- Low V. High High Many Many Quick Proof +++ High Low Low Few None Slow Lack of Proof+ Opportunities White Biotechnology/Industrial Biot. Maturing Biotechnology Firms Low Very Few Accepted Large numbers Accepted Yes Threats Green Genetic Technology Competition over High Potentials Danger of Exodus of Key Industries Commercialization Abroad Competition to West Clear Consumer Benefits Growth of Aged Population Controversial Little Debatable Low Yes: Drugs/ Fermentation Products needs to be increased No : 60% youth Applicable V. High Biotech Flourishing Low Yes/No (East) High Yes Low Acceptance Very High High Danger Yes; including Patents Yes from East Low Yes 16/4/2014 RD_UOK_April-2014 180 SWOT (strengths, Weakness, Opportunities, Threats) analysis in Life Sciences
  181. 181. Western India : Revenues Rs. 12,137 Crores (=43% share) Aurangabad : Agri-/bio-manufacturing; Mumbai : Bio-pharmaceuticals & Stem Cell Research; Ahmedabad/ Baroda : Agri-biotech, Bio-pharmaceuticals, Enzymes, Bio-information & Contract Research Pune : Agri-biotech, Bioinformatics, Bio-processing, Stem Cell Research & Vaccines Southern India : Revenues Rs. 5084 Crores (=16% share) Chennai : Bio-information, Bio-pharmaceuticals, Genomics, Marine Biotech. 48 Firms Hyderabad : Vaccines Mysore : Bio-diesel Bangalore : Industrial Biotech Northern India : Revenues Rs. 1453 Crores (=15% share) Delhi/ Gurgaon/ Noida : Agri-biotech, Bio-fuels, Genomics Lucknow : Bio-information & Bio-pharmaceutics 48 Firms 115 Firms 120 Firms 16/4/2014RD_UOK_April-2014 181
  182. 182. Challenging Areas in Tech Management 16/4/2014RD_UOK_April-2014 182  IP Mining  FTOs  Technology Mapping (BIRAC initiated this-2012)  Infringements  Licensing  Institutional IP policies  How to gel Public and Private effort ??  IP rights are being felt as a burden to innovation?
  183. 183. 16/4/2014RD_UOK_April-2014 183 Role of Public Private Partnerships Government BIPP/SBIRI •Funding Agency Private CRS/BIG Charitable •Academic Institution •Industry •CRO •Marketing Agency
  184. 184. 16/4/2014RD_UOK_April-2014 184 Innovation/ Proof of Concept/ Product Validation/Product Development/Sale Deliberate on Royalty issues
  185. 185. 16/4/2014 RD_UOK_April-2014 185 “India BT Industry to reach Rs. 36,107 by 2010”-BioSpectrum, October, 2010
  186. 186. 16/4/2014RD_UOK_April-2014186 The articles below were the top 10 for 2012. Some surprised me as to how fast they rose in the rank. I hope you read them all ready, but if you have not, here they are: •3 Main startup traits attract money and talent •Working hard is not enough •The One Word Entrepreneurs Do Not Say •Indecision can kill your business •Freaking Out is Not a Management Style •Need Money? A Few Links to Possible Investors •Are You Involved or Committed in a Startup? •The best guru for entrepreneurship and startup for your company •Networking is not a one sided activity •Mergers and acquisitions take thought and planning Taffy Williams is on Twitter by @twilli2861
  187. 187. Thank you Questions ? (rdhar_in@yahoo.com) 16/4/2014 RD_UOK_April-2014 187
  188. 188. (rdhar_in@yahoo.com)16/4/2014 RD_UOK_April-2014 188
  189. 189. 16/4/2014RD_UOK_April-2014189
  190. 190. 16/4/2014RD_UOK_April-2014190

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