The Academic Commercialization and Technology Transfer Pathway: University of Pittsburgh as a Model Technology Transfer Marc S. Malandro, Ph.D. firstname.lastname@example.org Associate Vice Chancellor for Technology Management and Commercialization Why Does the Government Invest in Research? Government Funding of Reservoir of Basic Research Knowledge In Academia New Increased New Companies Efficiency Industry (Jobs) Taxes Vannevar Bush Reservoir Theory of Science, The Endless Frontier, 1945 Knowledge Expectation “Society, having funded much of the University based research, has an expectation that the fruits of that research will improve the human condition.” Niels Reimers, Co-Founder AUTM 1987 What is Technology Transfer? Within the context of the academic research environment, technology transfer is the migration of new discoveries and innovations resulting from scientific research to the commercial sector, principally through patenting and licensing new inventions. Overview of Technology Transfer Patent Office Investigator Commercial Entities University/Technology Transfer Office Why Care About Technology Transfer? • While academic R&D is a small proportion of total U.S. R&D, academic basic research comprises roughly 40-50 percent of total U.S. basic research • Nearly 60 percent of academic R&D is funded by the federal government Source: NSF Science and Engineering Indicators, 2002. History of Academic Patenting • While patenting activity dates back to 1900s, most universities resisted direct involvement and some discouraged it • Rights to inventions from federal funds typically remained in the public domain • Cumbersome waiver process required for patenting Source: NSF Science and Engineering Indicators, 2002. Increase in Academic Patenting • University patenting surged from less than 250 patents granted in 1975 to over 3,000 patents granted in 2000 • Publicly funded biomedical research accounts for a major share of patents Source: NSF Science and Engineering Indicators, 2002. The BAYH-DOLE Act Public Law 96-517 Patent and Trademark Act of 1980 • Allow small business and non-profit organizations to retain title to innovations made under federally-funded research programs • Promote investment by the private sector in commercialization of federally funded research discoveries for the public good Bayh-Dole Provisions • Ensure that licensees of the technology diligently pursued commercialization of the inventions • Must file patents on inventions they elect to own • Government retains non-exclusive license and march-in rights Why Do Universities License Technology • Generate licensing revenue and research funding • Dissemination of new knowledge for the benefit of society • Development of University technology into products • Provide avenue for faculty members to interact with business • Stimulate economic development • Generate favorable publicity for the University Outcome of Technology Transfer Research $38.52 billion Invention 15,510 disclosures 1 per $2.47 million IP Protection 7,921 new patent applications 1 per $4.86 million Commercialization 4,516 licenses and options 374 company starts 2003 Licensing Survey Association of University Technology Managers Top Five Recipients of License Income – 1998 vs 2004 1998 1998 2004 • University of California System $73.1.0 M $74.3 M • Columbia University $61.6 M N/A • Florida State University $46.6 M $14.3 M • Stanford University $43.2 M $47.2 M • Yale University $33.3 M N/A 2004 1998 2004 • New York University $2.5 M $109 M • University of California System $77.0 M $74.3 M • Wisconsin $16.1 M $47.7 M • Stanford University $43.2 M $47.2 M • University of Minnesota $3.2 M $45.5 M 1998 and 2004 Licensing Survey Association of University Technology Managers Evolution of Technology Transfer Office Models 1990’s 2000’s • Legal or Administrative • Business/Marketing Model Model • Viewed as a legal or • Viewed as a ‘business’ administrative process within University • Based in the Office of • Independent Research or University organization within General Counsel University University of Pittsburgh Research Research Expenditures in Fiscal Year 2005 • Total Sponsored Grants and Contracts $602 M • Non-Federal Funding $193 M • Federal Funding $489 M • Number of Grants 3011 • Number of Grants $ 1 M 60 12th in Total Federal Awards 7th in National Institutes of Health Awards University of Pittsburgh Office of Technology Management Mission To facilitate the development of products and processes from University technology for the benefit of the University, its faculty and staff, and the community. OTM Services to Innovators • Counseling and education on intellectual property and technology transfer issues • Assistance on the preparation of invention disclosures • Strategic planning for transfer of technology to commercial interests • Negotiation of contracts for transfer of technologies to commercial interests • Management of post-licensing reporting, revenue collection and proceeds distribution Pitt Innovator Education, Networking and Assistance • Coursework • Academic Entrepreneurship: The Business of Commercial Innovation • From Bench-top to Bedside: What Every Scientist Needs to Know • Workshops and Seminars • Faculty and Staff Development Program: Protecting Intellectual Property: Patents and Copyrights • University Outreach • Department, Center, Institute and School: Sessions on protecting IP and technology licensing • Lectures and Events • Limbach Lecture Series – Peer scientists share their experiences in commercialization • Bio-blasts – quarterly regional networking events • Science 2006 Technology Showcase • Publications • OED – Bi-weekly newsletter on entrepreneurship for faculty • OTM – Monthly newsletter on new technologies and innovations Other Innovator Resources University of Pittsburgh Technology Commercialization Alliance Office of Technology Management Office of Institute for Enterprise Entrepreneurial Development Excellence Swanson Center for Product Innovation University External Resources Resources A collection of University and external resources available to Pitt Innovators interested in commercial innovation and academic entrepreneurship Evolution of Technology Commercialization at Pitt 1996 2006 • Licensing Professionals 3 6 • BD Professionals 0 2 • Marketing Professionals 0 2 • IP Professionals 0 2 • Support Staff 2 10 • Invention Disclosures 46 165 • Patents Issued 10 22 • Licenses 6 54 • Companies Formed 2 6(2) OTM Sources of Pre- Commercialization Funding • Provost • University Development Fund • Innovation Works • University Innovation Fund • Pittsburgh Life Science Greenhouse • Technology Development Fund • MPC Corporation (Heinz Foundation) • Technology Transfer Grants • DCED • Keystone Innovation Zone Grants Overview of the Technology Commercialization Pathway Research Invention IP Disclosure Protection Licensing TTC Strategy Evaluation Overview of the Technology Commercialization Pathway Research Invention IP Disclosure Protection Licensing TTC Strategy Evaluation Overview of the Technology Commercialization Pathway Research Invention IP Disclosure Protection Licensing TTC Strategy Evaluation What is an Invention? An invention is anything made by the hand of man that is a new, useful, and unobvious process, machine, manufacture, or composition of matter, or any new and useful improvement thereof • Conception • Reduction to Practice • An invention may or may not be patentable Discovery versus Invention Discovery Invention • Identification of a • Method of Treating a Biochemical Pathway Disease • Identification of a New • A Chemical Purified Species of Plant from a New Species • Observation of a of Plant Phenomena • Computer Software Inventorship • Those who conceive of the new ideas that are embodied in the claims of the patent • Inventorship is legally determined • Based on participation, contribution and value as perceived by others • Inventorship is not authorship and inventorship is not credit …if not but for… Public Disclosure of Inventions • Any publicly available description of work • Obvious – publication, presentation • Not Obvious – student thesis, discussions with other parties • Do not disclose inventions before properly protecting intellectual property • Use a confidentiality agreement to have discussions Invention Disclosure Submission www.otm.pitt.edu Invention Disclosure Submission • File as early as possible • Cleary describe the invention and the differences from what exists (prior art) • Identify and quantify the advantages over prior art • Identify applications and uses of the invention • Identify potential commercial markets and companies Invention Disclosure Submission A complete invention disclosure can answer the patent questions • Is the invention novel? • Is the invention useful? • Is the invention not obvious? If you have any questions or need help, call the OTM. Overview of the Technology Commercialization Pathway Research Invention IP Disclosure Protection Licensing TTC Strategy Evaluation Pitt Invention Evaluation Process Invention Electronic Invention Disclosure Submission Technology Transfer Committee Technical Patent Search Review Market Analysis Technology Transfer Committee Hold for Patent Release to Test Further Technology Inventor Market Evaluation Pitt Invention Evaluation Process • Is it protectable? • Patent, copyright, know how • Is it enforceable? • Infringement • Is it licensable? • The primary reason for investing in intellectual property protection is the ability to license the invention. Evaluation Criteria • Level of IP Protection • Related Industry R&D Activity • Inventor Reputation and Participation • Inventor R&D Activity • Promised Benefits and Novelty • Market Size • Competing Products • Development Status and Time to Market • Validation and Performance Overview of the Technology Commercialization Pathway Research Invention IP Disclosure Protection Licensing TTC Strategy Evaluation Types of Patents • Provisional – Establishes a filing date and provide 1 year to file a full patent application with claims • No claims are necessary in provisional • May be developed from a publication • Utility – How something works or is used; multiple claims • Design – How something looks; only one claim Differences Between US and International Patents • US – First to Invent • Most International – First to File • Very important to file protection before publicly disclosing to preserve foreign patent rights • Foreign protection very important to most companies What Does Patent Protection Provide? • The right to exclude others from making, using, selling or offering to sell the claimed invention during the patent term • Patent term typically 20 years from date of filing • Design patent typically 14 years from date of issue Standards for Patentability • Is the invention novel? • Not done before by someone else • Not previously put into the public domain • Not patented • Is the invention non-obvious? • Not a trivial extension • Not anticipated by someone reasonably skilled in the art • Is the invention useful? • Some data to show claimed activity Copyrights • Copyright is a form of protection to the authors of original works of authorship • To reproduce the work • To prepare derivative works based upon the work • To distribute copies of the work • Copyright arises automatically once an original effort has been fixed in a tangible medium • Written, computer disk, recording Copyrights Copyrightable Not Copyrightable • Books, periodicals and • Ideas manuscripts • Computer programs and • Facts databases • Titles • Stage plays and screenplays • Names • Music and motion pictures • Short phrases • Fine art, graphic art, photographs, prints and art • Blank forms reproductions • Maps, Globes, Charts • Technical drawings, diagrams, models Copyright Registration Registration not required but beneficial: • establishes a public record of the copyright claim; • necessary for filing an infringement suit; • establish prima facie evidence of validity if made within 5 years of publication; • registration made within 3 months of publication or prior to an infringement allows statutory damages. Other Aspects of Protecting Intellectual Property • Confidentiality agreement should be put in place before commercial discussions • Use material transfer agreements (MTA) for both incoming and outgoing materials • Defines intellectual property playing field • Be wary of MTAs from outside sources • Keep accurate, dated and countersigned records • Keep projects, funding, lab notebooks separate for different funding sources Overview of the Technology Commercialization Pathway Research Invention IP Disclosure Protection Licensing TTC Strategy Evaluation Licensing Strategy Intellectual Property Option License Start-Up Agreement Agreement Company Licensing Strategy • Option Agreement • Early stage technology that requires further development • Proof of principle – add value or reduce risk • Reach some minimal level of progress to be of interest to investors • Does not give rights to develop or sell products • Exclusive or non-exclusive • Convertible to license agreement on agreed terms Licensing Strategy • License Agreement – Existing Company • Technology likely to lead to a single product • Small number of large firms that dominate the field • Exclusive or non-exclusive • Capital requirements to enter the industry prevent startups from being competitive • Existing company may be able to get the technology to market faster Licensing Strategy • Start-Up Company Formation • Platform or disruptive technology with broad patent protection • Ability to generate interest from investors • Market size sufficient • Gross margins attractive • Viable business model • Begins with an option agreement conditioned upon milestones • Investment • Management team Overview of the Technology Commercialization Pathway Research Invention IP Disclosure Protection Licensing TTC Strategy Evaluation Technology Marketing • Inventors are the single most important step in marketing • 70% of licensing leads come from the inventor • Identify companies in technology area • Network at scientific and industry conferences • Respond in a timely manner • Have a plan for next steps in research • Forward all licensing interest to the OTM Technology Marketing • OTM Marketing Efforts • Technologies available for licensing are on the OTM web site • Focused business development relationships in specific technology areas • Relationships with local and national venture capital groups • Industry conferences Licensing Process • Identification of interest • Confidentiality agreement for scientific and IP due diligence • Discussion of license type • Option versus license agreement • Exclusive versus non-exclusive • Negotiation of financial, business, and legal terms License Agreement terms • License grant • Exclusive or non-exclusive • Field of use • Territory • License term • License Consideration • Upfront fee • Maintenance fees / Minimum annual royalty • Royalties • Other – Milestones, equity University Approach to Start-Up Company Formation PLATFORM CORPORATE PARTNER/ TECHNOLOGY SOPHISTICATED VC LEAD SEED MANAGEMENT FUNDING Faculty Involvement with Start-Up Companies • Permitted activities • Holding of equity • Sponsored research from company • Consulting relationship • Scientific Advisory Board • Entrepreneurial leave • Prohibited activities • Holding of greater than 20% equity • Serving as PI for sponsored animal research or clinical study • Holding Board of Directors seat • Holding management position in licensing company Licensing Proceeds Distribution • Patented Invention • Inventor – 30% • Inventor’s Department – 15% • University Development Fund – 10% • Patent Rights Fund – 30% • Office of Technology Management – 15% • Copyrighted Invention • Inventor – 50% • Inventor’s Department – 25% • Copyright Development Fund – 25% Proceeds distributed after expenses have been paid. Summary • Protection in place before public disclosure • Novel, useful, non-obvious • Innovator is key to the technology transfer process • Complete invention disclosure • Contact point for licensing interest • Contact the OTM with any questions on the process Questions?
Pages to are hidden for
"The Academic Commercialization and Technology Transfer Pathway"Please download to view full document