Patents and Trademarks 101. Workshop on patents and trademarks Sponsored by the Georgia Tech Library and USPTO.Runtime: 40:18 minutesFeatured speaker of Patents and Trademarks 101, presented on November 3, 2010 in the Georgia Tech Student Center Theater

Shlevin, Harold H.

Scholarly Materials And Research @ Georgia Tech

© 2010, Georgia Institute of TechnologyI P  E c o s y s t e m ,  E n t r e p r e n e u r s ,  a n d  S u s t a i n a b le  T e c h n o l o g y  C o m p a n i e sHarold H. Shlevin, PhDAdvanced Technology Development CenterEnterprise Innovation InstituteGeorgia Institute of Technologyshlevin@gatech.edu211/1/10 Enterprise Innovation InstituteHarold H. Shlevin• 25+ years leadership experience in pharma,medical devices & vaccines companies.–CEO Solvay Pharmaceuticals–Founder CIBA Vision Opthalmics, –Founder Tikvah Therapeutics• PhD, University of Rochester Medical School, Postdoc. Mayo Clinic• Assistant Professor – Mayo Medical School• Multiple advisory boards of for profit and not-for-profit organizations• Strong regional technology leader311/1/10 Enterprise Innovation InstituteWhat is Innovation?411/1/10 Enterprise Innovation Institute“Innovation U.” Report•“Virtually every combination of industry relationship or economic development activity can be found at Georgia Tech, and in a very real sense, the university is an operating partner with Georgia state government in the implementation and management of a variety of technology-focused initiatives.  P er h a ps  m or e th a n  a n y oth er  r es ea r ch  u n i ver s i ty i n  N or th  A m er i ca ,  econ om i c devel opm en t i s  a n  i n tegr a l ,  cr i ti ca l  com pon en t of  th e m i s s i on  of  th e G eor gi a  I n s ti tu te of  T ech n ol ogy , and this has been true from its very inception.”–Souther n Gr owth Policies B oar d, 2002511/1/10 Enterprise Innovation InstituteBuilding an Ecosystem41N u t r i e n t sS i g n s  o f  L i f eG r o w t hI n c u b a t i o nR e n e w a lN a t u r a lS e l e c t i o n611/1/10 Enterprise Innovation InstituteGT Research Distribution•Over half a  billion dollars total R&D on campus for FY2009!College ofEngineeringGTRICollege ofSciencesResearch CentersCollege ofComputingOther711/1/10 Enterprise Innovation InstituteNutrients• Recruiting research talent—worldwide• Georgia Research Alliance (GRA)–Eminent Scholars–Facilities/equipment• Reinventing academic disciplines–College of Computing–Emory/GT Biomedical Engineering Dept.811/1/10 Enterprise Innovation InstituteSigns of Life• Emphasis on interdisciplinary research• Research centers –Over 100 on campus, from textiles to nanoscience– BME, Nanotech, MARC, MiRC, GEDC, Broadband Institute, GTEC Tissues, etc.• GRA Phase Zero awards911/1/10 Enterprise Innovation InstituteNatural Selection• Intellectual property protection (OTL) • VentureLab–Business plan–Management–Money• GRA Phase I and II awards• GT Edison Fund• SBIR AssistanceC o m m e r c i a l i z a t i o n  S e r v i c e s1011/1/10 Enterprise Innovation InstituteIntellectual Property Goals• Reward the faculty for creation of valuable IP• Support innovation & strengthen research programs• Strengthen global reputation• Attract top-quality faculty & students• Add value to intellectual property• Strengthen industry relationships• Create successful entrepreneurs• Strengthen local technology community• Help human-kind1111/1/10 Enterprise Innovation InstituteConverging Challenges• Increasing number of disclosures drives overall demand• “The World is Flat” –Increasing GT demand for overseas filings • Drives patent cost from ~$15K to ~$100K–Increasing competition for research partnerships from overseas universities• Increasing ratio of biotech at GT (requires overseas protection)• USPTO proposed limitations on claims, etc.1211/1/10 Enterprise Innovation InstituteIP Mgmt./EvaluationInventionDisclosuresDept. Chairs /Deans / GTRITechnologyEvaluationPath?Rights toFaculty?Initiate IP Prot.Need more information / developmentMarketEvaluationTechnologyAnalysisProtectIP?MarketAnalysisPatentApplicationExternalCounsel$...continuedExport ControlIndustrial ContractsScreensR es pons ibilityGTRCEI2 / CS$ $1311/1/10 Enterprise Innovation InstituteIP Business DevelopmentRights toFaculty?VentureLab Tech. MarketingPath?Startup / Spinout Industrial LicenseConsultingGeorgiaResearchAlliance$Licensee? Rights toFaculty?Funding& CEO?Term Sheet NegotiationRights toFaculty?LicenseNegotiationComplianceReviewStandardTemplates...continuedR es pons ibilityGTRCEI2 / CSMarketingWhite PaperExternal CounselBusinessPlanConflict ofInterest PlanStandardTemplatesCOI Review1411/1/10 Enterprise Innovation InstituteIP Business DevelopmentVentureLab1511/1/10 Enterprise Innovation InstituteVentureLab• Founded September 2001–Now a model for other universities–Part of Enterprise Innovation Institute• Staff has substantial private-sector experience• Faculty-focused process –Risk identification and mitigation–Venture-backable innovations• Goal: Successful startup companies based on Georgia Tech research1611/1/10 Enterprise Innovation InstituteVentureLab•Market•Milestones•Meetings•Management•Money1711/1/10 Enterprise Innovation InstituteMoney•Assistance with small-business grants from eleven Federal agencies.•Grants and loans to startups based on Georgia university research.•Equity investments in startups with a connection to Georgia Tech.1811/1/10 Enterprise Innovation InstituteGeorgia SBIR Assistance• Small business R&D funding available from eleven Federal agencies–NASA, DOD, DOE, NIH, EPA, etc.• Grants, not loans or equity!• For help with SBIR and STTR process, visit <http://www.innovate.gatech.edu/sbir>.• Up to $850K availableacross two phases ofdevelopment1911/1/10 Enterprise Innovation InstituteGeorgia Research Alliance• Recruiting Eminent Scholars from all over the world to Georgia• Investing in university capital equipment–Over $600 million in last 15 years• Innovation grant program–Phase 1: up to $50K to university R&D–Phase 2: up to $100K to university (must be matched—equity, SBIR, sale of services, etc.)–Phase 3: up to $250K loan to company (must be repaid upon success or leaving Georgia)2011/1/10 Enterprise Innovation InstituteGRA Matching FundsProvides up to 4:1 non-dilutive leverage for initial outside investment:E qu i ty,  O th er  G r a n ts ,  etc.Phase I $50K grant to universityPhase II $100K validation investment$100K matching grant to univ.Phase III $250K loanT ota l $ 10 0 K $ 4 0 0 K2111/1/10 Enterprise Innovation InstituteVentureLab•Market•Milestones•Meetings•Management•Money2211/1/10 Enterprise Innovation InstituteIncubation• Advanced Technology Development Center (ATDC)• GRA Phase III loans• Ga. Seed Capital Fund• Minority Business Enterprise Center• National VC attention• Centers of Innovation–Statewide tech areasE n t r e p r e n e u r  S e r v i c e s2311/1/10 Enterprise Innovation InstituteATDC Offerings• Consulting –Strategic business advice• Community–Interaction with other entrepreneurs• Connections–Connections to people and resources• Centre –Facilities designed for startups• Credibility –Instant recognition2411/1/10 Enterprise Innovation InstituteCycle of Renewal• Serves as a bridge to Georgia Tech services and resources–Expand interaction with key local, state, national and international corporations–Seminars, workshops & technology briefings–Access to test beds, research labs, unique equipment & expertiseS t r a t e g i c  P a r t n e r s  O f f i c e2511/1/10 Enterprise Innovation InstituteCycle of Renewal• Successful companies–Sponsoring research–Hiring GT graduates–Spinning off new companies• Successful graduates–Charitable giving–Angel investment–Mentoring• More nutrients for the ecosystem!K l a u s  A d v a n c e d  C o m p u t i n g  B l d g .2611/1/10 Enterprise Innovation InstituteBuilding an EcosystemN u t r i e n t sS i g n s  o f  L i f eG r o w t hI n c u b a t i o nR e n e w a lN a t u r a lS e l e c t i o nImportance of Patents to Pharmaceutical InnovationINDUSTRYWould NOT have been IntroducedWould NOT have been DevelopedPharmaceuticals 65 65Chemicals 30 38Petroleum 18 25Machinery 15 17Electrical Equipment 1 11Mansfield, Mgmt Sci., Feb., 1986Sources: Innovation.org, Great Moments in Innovation,  http://www.innovation.org/index.cfm/nonav/Great_Moments_in_Innovation; NIH, National Institute of Allergy and Infectious Disease, Tuberculosis (TB), Age of Optimism, http://www3.niaid.nih.gov/topics/tuberculosis/Research/researchFeatures/history/historical_optimism.htm.1980s – 20001950s – 1970s1900s – 1940s1930s & 1940s1932 – First antibiotic (sulfa drugs)1935 – Discovery of cortisone           1938 – First epilepsy Rx1948 – First chemotherapy Rxs1960s & 1970s1963 – Measles vaccine1967 – First beta blocker 1968 – First anti-rejection medicines for organ transplants1972 – Advances in anesthesia1977 – First non-surgical treatment for ulcers1978 – First biotech product(synthetic human insulin)1990s1993 – First Alzheimer’s Rx1994 – New breast cancer Rx- Polio eradicated in the Americas1995 – AIDS Rx advance (HAART)1995–97 – Four new classes of oral diabetes Rxs1997–98 – Advance in Parkinson’s Therapies1900–19291900 – U.S. life expectancy is 451908 – Tuberculosis vaccine1922 – Insulin for diabetes1924 – Tetanus vaccine1928 – Discovery of penicillin1950s1950 – Discovery of prednisone1951 – First Rx for depression1953 – First leukemia Rx1954 – Polio vaccine1958 – First diuretic to treat high blood pressure1980s1981 – First ACE inhibitor to treat high blood pressure1986 – First monoclonal antibody                 treatment1987 – New class of depression medicines (SSRIs)– First AIDS Rx– First statins to lower cholesterolSelected Advances in the 20th Century*Note: “Other” includes medical care provided  by private employers for employees at their work site, government spending for non-specified medical care by service usually delivered in schools, military field stations, and community centers.Source: CMS, “National Health Expenditures,” at http://www.cms.hhs.gov/NationalHealthExpendData, accessed January 6, 2009.Administrative& Net Costs7%Home HealthNursing &Home Care8%Physicians & ClinicalServices21%HospitalCare31%Other22%Rx Drugs10%Health Care Dollar SpendingSource: CMS, Historical National Health Expenditures by Type of Service and Source of  Funds: Calendar Years 1960–2006, at http://www.cms.gov, accessed Jan. 9, 2007.$0$500,000$1,000,000$1,500,000$2,000,0002006200119961991198619811976197119661961Total Health Care SpendingTotal Health Care Spending Less Rx MedicineMillionsIn 2006, U.S. National Health Expenditures were $2.1 trillion; without prescription medicines, the total would have been $1.9 trillionTotal Health Care Expenditures With and Without Prescription Medicines 1960–2006Medicines Account for a Small Share of Health Spending GrowthSources: 1Burrill & Company, analysis for PhRMA, 2010 (Includes PhRMA research associates and nonmembers) in PhRMA, “Profile 2010, Pharmaceutical Industry;” PhRMA, “PhRMA Annual Membership Survey,” 2010; 2Adapted from E. Zerhouni, Presentation at Transforming Health: Fulfilling the Promise of Research, 2007; 3NIH Office of the Budget, “Natiional Institutes of Health: Enacted Appropriations for FY 2008-FY 2010,” http://officeofbudget.od.nih.gov/pdfs/FY11/FY%202010%20Enacted%20Appropriations.pdf. There is an ecosystem of science and biotechnology.  Public organizations, patient organizations, universities, Congress, FDA, all of this is an ecosystem that is envied in the rest of the world.– E. Zerhouni, Director of NIHPrivate Sector –$65.3B1Clinical ResearchBasic ResearchTranslationalResearchClinical Research Basic ResearchTranslational ResearchNIH – $31.2B3Government and biopharmaceutical industry research are complementary““Federal & Industry Roles in Research and Development05001000150020002500300035001997 1999 2001 2003 2005 2007 2009USAll OtherEUJapanNumber of Compounds in Development, by Region,*1997–20091*Note: Reflects the number of compounds in clinical trials or awaiting approval as of June of each year. Compounds in development for multiple regions are counted in each region for which regulatory approval is sought, and multiple indications are counted only once.Sources: 1Adis R&D Insight, Custom data run, February 2009, January 2010; 2G. Verheugen, “Address to the Concluding Session of the European Track” (Lyon) 2005.…in the late 1980s only 41% of the top 50 innovative drugs were of American origin, in the late 1990s…[it had] climbed to 62%....  In 1990, the pharmaceutical industry spent 50% more on research in Europe than in the U.S.  In 2001, the situation was reversed with 40% more spent in the U.S.2–Gunter Verheugen, Vice-President of the European Commission for Enterprise and Industry““Medical Research in U.S. Outpaces the Rest Of the WorldSources: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org; CBO, Research and Development in the Pharmaceutical Industry, 2006.Developing a new medicine takes an average of 10–15 years; the Congressional Budget Office reports that “relatively few drugs survive the clinical trial process”  INDEFINITEDrug DiscoveryPreclinical Clinical Trials FDA Review Scale-Up to Mfg.Post-MarketingSurveillanceONE FDA-APPROVED DRUG0.5 – 2 YEARS6 – 7  YEARS3 – 6  YEARSNUMBER OF VOLUNTEERSPHASE 1PHASE 2PHASE 35250~ 5,000 – 10,000COMPOUNDSPRE-DISCOVERY20–100 100–500 1,000–5,000IND SUBMITTEDNDA SUBMITTEDDrug Development Takes LongerSources: 1J. DiMasi and H. Grabowski, "The Cost of Biopharmaceutical R&D: Is Biotech Different?," Managerial and Decision Economics, 2007; J. DiMasi et al., “The Price of Innovation: New Estimates of Drug Development Costs,” Journal of Health Economics, 2003.$1.3B  $800M$300M  $100M$0.0$0.2$0.4$0.6$0.8$1.0$1.2$1.41979 1991 2000 2005Cost to Develop One New Drug1Billions (Constant Dollars, Year 2000)The Cost of Developing a New Drug Has IncreasedSource: 1Tufts Center for the Study of Drug Development, “New drugs entering clinical testing in top 10 firms jumped 52% in 2003-05,” Impact Report, 2006.Approximately 20% of self-originated new drugs that enter clinical testing willreceive U.S. marketing approval.1Clinical Approval Success Rates by Therapeutic Class1Probability of Success for New Drugs Is Small$701$434$299$162$87 $39 $21 $6 ($1)$1,880$0$500$1,000$1,500$2,0001 2 3 4 5 6 7 8 9 10After-Tax Average R&D CostsNote: Drug development costs represent after-tax out-of-pocket costs in 2000 dollars for drugs introduced from 1990–94.  The same analysis found that the total cost of developing a new drug was $1.3 billion in 2006.  Average R&D Costs include the cost of the approved medicines as well as those that fail to reach approval.Lifetime Sales Compared to Average R&D CostsNew Rx Drugs Introduced Between 1990 and 1994, Grouped by Tenths, by Lifetime Sales  After-Tax Present Value of Sales (Millions of 2000 Dollars)Sources: J. A. Vernon, J. H. Golec, and J.A. DiMasi, "Drug development costs when financial risk is measured using the Fama-French three-factor model." Health Economics, (2009). ; J. DiMasi and H. Grabowski, “The Cost of Biopharmaceutical R&D: Is Biotech Different?,” Managerial and Decision Economics, 2007.Few Medicines Are a Commercial Success3711/1/10 Enterprise Innovation InstituteWhy Make the Investment?“Without the sense of security which property gives,The land would still be uncultivated”F. Quesnay, 17733811/1/10 Enterprise Innovation InstituteFor Further InformationH a r ol d H .  S h l evi nManager, Advanced Technology Development CenterGeorgia Institute of Technology<shlevin@gatech.edu>(404) 385-7372

IP ecosystem, entrepreneurs, and sustainable technology companies

https://smartech.gatech.edu/bitstream/1853/36144/1/IPecosystem-Shlevin.pdf

IP ecosystem, entrepreneurs, and sustainable technology companies

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