INSEAD Abu Dhabi, UAE January 9, 2011 Dr. Ashley J. Stevens Special Assistant to the Vice President for Research Senior Research Associate Institute for Technology Entrepreneurship and Commercialization School of Management Boston University
Objectives Discuss: History Impact of the Bayh-Dole Act as it turns 30 Where the US is heading Implications for the Gulf 2
A Look Back 3
Before Bayh-Dole Government owned all the patents that came from federally funded research Even partially federally funded 70% of all academic research funding Would only grant non-exclusive licenses No incentive to make pioneering investment to prove viability of embryonic inventions Separated the inventor At the university from the invention Owned by the government 4
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Bayh-Dole PL 96-517 The Patent and Trademark Amendments Act of 1980 Main components: Universities could elect to retain title to the results of Federally funded research Universities were required to share proceeds with inventors Most restrictions on licensing terms were removed US manufacture required for products to be sold in the US Small business preference Non-exclusive license to US Government for its own use Ability to grant compulsory license in the public interest No funding added or removed Remaining licensing restrictions were eliminated in the Stevenson-Wydler Act (PL98-642) in 1984 6
Bayh-Dole A very simple Act The government was completely unobtrusive Turned responsibility completely back to the universities March-in was the only possibility for the government getting involved Has never been exercised 7
An Assessment 8
Impact It worked: Expansion of academic licensing offices Initially staffed by patent attorneys and research administrators Second wave was people with small company business experience The only reason to protect technology is in order to transfer it! Expansion of academic patent applications and issuances Substantial research collaborations between companies and universities to access new technologies Substantial growth in academic royalty income about a decade later Emergence of high technology clusters anchored by major research universities 9
Impact (2008) 20,115 invention disclosures 18,949 patent applications filed 3,156 patents issued 5,132 new options/licenses executed 32,405 licenses/options active 15,498 yielding some sort of income 7,917 yielding running royalties Source: Association of University Technology Managers 10
Licenses Granted 50% small companies 35% large companies 15% start-up companies 56% non-exclusive 44% exclusive 11
Source: AUTM 2008 Licensing Activity Survey unless otherwise noted 12
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April 4, 1992 BusinessWeek -- Industrial Policy 18
October 19, 1992 BusinessWeek HotSpots 19
BusinessWeek HotSpots Map 20
A major research university Quality of life Build on local industry Cooperation between local university, business and government Technology transfer from the university Funding sources -- state, VC, angels Incubators Ingredients of a High Tech Cluster Phases of Economic Development Start-ups New division of major US company Foreign companies move in Export lead growth 21
A major research university Quality of life Build on local industry Cooperation between local university, business and government Technology transfer from the university Funding sources -- state, VC, angels Incubators Ingredients of a High Tech Cluster Phases of Economic Development Start-ups New division of major US company Foreign companies move in Export lead growth 22
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Start-Up Companies 6,652 formed 1980-2008 72% located in same state as institution Every state except Alaska 12.3% from California institutions 11.8% from Massachusetts institutions 363 by MIT 349 by University of California System 175 by University of Utah 52% still active in 2008 AUTM Annual Licensing Activity Survey 1994-2008 24
The Pharmaceutical Industry in Massachusetts 25
Pharmaceuticals in Massachusetts In 1975, one pharmaceutical company in Massachusetts US HQ of Astra AB Two events: Spin-outs from Harvard, MIT, BU Some made it Biogen, Genzyme Some didn t and got acquired Genetics InstituteWyeth/Pfizer Massachusetts Biotechnology Research Park First big pharma arrival BASF Abbott 26
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Impact of Academic Research in Healthcare 153 marketed drugs and vaccines discovered in whole or in part in PSRI s 9% of all NDA s 1990 2007 21% of most innovative drugs $103 billion global sales 28
The Internet CERN University of Illinois Urbana-Champaign University of Illinois Urbana-Champaign (Stanford) Carnegie-Mellon MIT Stanford 29
Major Products in Many Sectors V-chip Hollow optical fibers PSA test Honeycrisp apple Cochlear implant Lightning detection technology Cell phone technologies AUTM Better World Report 30
Economic Impact 1996-2007* 279,000 jobs created $187 billion to added to U.S. GDP * Roessner, J. Bond, S. Okubo, M. Planting, The Economic Impact of Licensed Commercialized Inventions Resulting from University Research, 1996-2007 Final Report presented to the Biotechnology Industry Organization, September 9, 2009 31
The Impact on Science (and Scientists) 32
The The Traditional New Scientific Paradigm 33
The New Scientific Paradigm The Patent-Paper-Pair Fiona Murray, MIT 50% of papers in Nature Biotechnology 1997-1999 had a corresponding patent 1 33% of biotech papers in Science and Nature had a corresponding patent 2 1 Murray, F., Stern, S., Do Formal Intellectual Property Rights Hinder the Free Flow of Scientific Knowledge? An Empirical Test of the Anti-Commons Hypothesis, Journal of Economic Behavior and Organization (2007), doi:10.1016/j.jebo.2006.05.017 2 Lebovitz, R. M. (2007). "The Duty to Disclose Patent Rights." Northwestern Journal of Technology and Intellectual Property 6 (Fall 2007): 36-45. 2009 Ashley J. Stevens All Rights Reserved. Do not modify or copy. 34
Faculty Participation Career Disclosures % Never 64.2 Once 14.8 Twice 7.6 Three to five 11.4 Six or more 2.0 Thursby & Thursby 35 2009 Ashley J. Stevens All Rights Reserved. Do not modify or copy.
A Look Forward 36 2009 Ashley J. Stevens All Rights Reserved. Do not modify or copy.
Obama Initiative Issued a Request for Information Responses due May 30 The genius of Bayh-Dole was that it provided no new money It didn t need periodic reauthorization Reauthorization = Opportunities for meddling Time to change this 210 responses received Still digesting them 37
AUTM s Response to the RFI Focus on the Valleys of Death 38
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AUTM s Response to the RFI Our Valleys of Death! Funding technology transfer office operations Proof of concept funding Market pull support Incentivize angel funding 40
The Economics of Technology Transfer 41
Financial Performance Financial Contribution Number % Loss making 68 52.3% Gross profitable 27 20.8% Net profitable 14 10.8% Self sustaining 21 16.2% Total 130 Abrams, Leung and Stevens, Research Management Review, What drives technology transfer Is it all about the money? Fall/Winter 2009 42
Why such a Difficult Business Model? Income is distributed very unevenly A business of a few big hits $3.4 billion income in 2008 24.1% Northwestern Lyrica monetization 12.0% City of Hope Cabilly, settlement of lawsuit with Genentech 16.1% MSK (settlement), CHOP (monetization) and Sloan- Kettering (settlement) 47.9% remaining 180 Only 198 licenses generated over $1 million 1.3% of 15,498 generating any income Distribute 70-100% of what we generate Inventors Labs, Departments, Colleges 43
Managing University Intellectual Property in the Public Interest National Research Council Recommendation 1: The leadership of each institution president, provost, and board of trustees should articulate a clear mission for the unit responsible for IP management, convey it to internal and external stakeholders, and evaluate effort accordingly. The mission statement should embrace and articulate the university s foundational responsibility to support smooth and efficient processes to encourage the widest dissemination of university-generated technology for the public good. Whether the primary emphasis is on global, national, regional, or local benefits is likely to depend significantly on the nature of the IP and vary with the type of institution (public or private), its history, research-intensity, primary sources of financial support, and educational characteristics. This places IP-based technology transfer squarely within the university s core mission to advance discovery and learning and to contribute to the wellbeing of society while recognizing institutional differences. 44
AUTM s Recommendations 1. Fund technology transfer offices directly 45
Is there an academic 25% Rule? Aka The Stevens Rule 46
2008 Licensing Activity Survey Invention Disclosures 19,554 New US Patent Applications filed 11,626 59% Licenses Signed 5,002 26% US Patents Issued 3,156 16% Start-Ups formed 584 3% Active Licenses 30,920 47
Why Is This So Hard? Should we invest more to make them less embryonic? Translational Research von Liebig (UCSD) and Deshpande (MIT) Centers Philanthropically funded Von Liebig $10 million Deshpande $20 million Founded 2001 and 2002 48
Results Von Liebig Deshpande Annual Investment $1.2 mm $1.7 mm Projects Funded 66 64 Average Investment $42k $109k Licenses 4 (6%) 1 (2%) Start-Ups 16 (24%) 10 (16%) Total Capital Raised $71 mm $88.7 mm Average per Start-Up $4.4mm $8.9mm Leverage 105x 81x Source: Kauffman Foundation, 2008 49
Results Still a 25% overall success rate BUT Rate of start-ups increased 6x vs. normal AUTM rate 80-100x leverage of VC funds raised vs. translational funding investment Consistent with preliminary results from Coulter Translational Research Programs in Biomedical Engineering: 10 major research universities with BME programs 5 year program Medical devices Program Director a senior level medical device industry 50
AUTM s Recommendations 1. Fund technology transfer offices directly 2. Provide proof of concept funding 51
Why Is This So Hard? Academic inventions are driven by Technology Push Need to find their Market Pull Mentorship programs Entrepreneur-in-residence programs 52
AUTM s Recommendations 1. Fund technology transfer offices directly 2. Provide proof of concept funding 3. Provide funding for mentorship and entrepreneur-in-residence programs 53
Sources of Initial Funding for University Spin-Outs Source 2004 2005 2006 2007 2008 Individuals No External Funding 57 55 54 86 76 Friends and Family 94 104 123 135 109 Individual Angels 49 48 82 82 62 Angel Network 26 14 23 32 31 Institutions State Funding 36 29 41 63 63 Venture Capital 85 84 81 88 92 Corporate Partner 25 28 45 33 38 Own Institution 26 28 42 51 53 SBIR/STTR 32 43 45 42 43 Other 28 40 52 47 42 Total 458 473 588 659 609 54 Source: AUTM Annual Licensing Survey
Sources of Initial Funding for University Spin-Outs Source 2004 2005 2006 2007 2008 Individuals No External Funding 57 55 54 86 76 Friends and Family 94 104 123 135 109 Individual Angels 49 48 82 82 62 Angel Network 26 14 23 32 31 Institutions State Funding 36 29 41 63 63 Venture Capital 85 84 81 88 92 Corporate Partner 25 28 45 33 38 Own Institution 26 28 42 51 53 SBIR/STTR 32 43 45 42 43 Other 28 40 52 47 42 Total 458 473 588 659 609 55 Source: AUTM Annual Licensing Survey
AUTM s Recommendations 1. Fund technology transfer offices directly 2. Provide proof of concept funding 3. Provide funding for mentorship and entrepreneur-in-residence programs 4. Provide an investment tax credit for individuals who invest in a university spin-out company that s raised less than $5 million in equity 56
Implications for the Gulf Region 57
Exporting the US Experience Only 3 choices for how to manage academic IP The research sponsor usually the government US UK The professor s privilege Most of Europe The institutional ownership model The US post-bayh-dole model UK followed in 1988 Abolished the National Research and Development Corporation Europe followed ~1999 Emerging economies now following 58
The Fundamental Business Model Suppose a university gets a 5% royalty on sales of an important product Or owns 5% of a spin-out company that gets sold It s doing a good job But 95% of the economic impact is in the private sector Not in return to the university Reflects the private investment in developing the technology Technology transfer needs to be part of a country s economic infrastructure Like roads, railways and airports Government needs to support it accordingly 59
So, how do we position it with Government? Make the right economic argument from the start: Technology transfer does not support itself at the university level University presidents loathe to support the national economy Little activity in the UK till Third Stream Funding in 1999 UK Government understands the long term economic development argument University research funding and third stream funding survived recent budget cuts New 200 million translational research center program based on German Fraunhofer model 5 years of government support is not enough Scandinavian experience Make the economic infrastructure argument from day 1 60
Implications for the Gulf Rapid expansion of well funded, research universities Opportunity to diversify the economy Long term program for the long term Need to get technology transfer right from the start Foreign campuses will help Will bring their policies to the region e.g., BU Dental School in Dubai Wealth of global experience to draw on US AUTM Europe ASTP Training critical In country Fellowships 61
Questions? astevens@bu.edu 62