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Transfer of Early Stage
Medical Technologies
2014 Healthcare Congress
10-11 June 2014
Sara Nakashima
Stanford University
Office of Technology Licensing
Starting Material: R&D Funding
Science Vol 342,
Nov 2013
U.S. Research Funding
at Research Institutions
AUTM U.S. Licensing
Activity Survey FY2012
Stanford’s Entrepreneurial
Environment
• Federal government funding of research
• $664M = 76% of research funding at Stanford (FY13)
• Students key to technology transfer
• Largest grantor of graduate engineering degrees in US.
• Graduates come from all over the world and many stay.
• Entrepreneurship encouraged
• Clear conflict of interest policy, but faculty can start companies and consulting is
allowed 1 day/week
• Positive feedback loop
• Lots of expertise, lessons and successes
based on presentation from Stanford President John Hennessey
Stanford Biodesign
biodesign.stanford.edu
Biodesign Process: Identify ● Invent ● Implement
Stanford Biodesign
Annals of Biomedical Engineering,
Vol 41, No 9, Sept 2013
Entering the program… …and leaving it.
Stanford OTL’s Mission
To promote the transfer of Stanford
technology for society’s use and benefit
while generating unrestricted income to
support research and education.
Stanford OTL’s Approach
Do what’s best for the technology.
Plant a lot of seeds.
Be flexible and creative.
Stanford OTL’s Process
Tech Transfer: Invention Disclosure
650-245-4925
• Who are the inventors and owners?
• What is the purpose of the technology?
• Is there ongoing research?
• Are there any third party rights?
• Upcoming public disclosures?
Tech Transfer: Assesment
650-245-4925
• Is the market big enough?
• Is the invention evolutionary or revolutionary?
• What is the stage of development?
• What are the current and competing technologies?
• Is it a product or a company?
• What are the risks?
• What is the inventor’s track record?
2006 cardiac rhythm monitor
Tech Transfer: Intellectual Property
• Can it be licensed without a
patent?
• Is it patentable?
• Is it enforceable?
• How easy is it to invent around
the patent?
• US or worldwide rights?
Tech Transfer: Marketing
• Reasons to market:
• Find a licensee
• Get feedback on a
technology
• Mitigate possible conflict of
interest issues
Tech Transfer: Selecting a Licensee
• Will this company make a good
home for the technology?
• What is their plan for
developing the technology?
Uday Kumar
iRhythm Founder
Tech Transfer: License Terms
Non-Financial
• Field of Use
• Exclusivity
• Territory
• Diligence
Financial
• Issue Fee
• Equity
• Annual maintenance fees
• Earned Royalties
• Sublicensing Income
• Patent Reimbursement
• Milestones
• License Assignment Fee Stanford’s sample agreements:
http://otl.stanford.edu/industry/resources/industry_res.html?headerbar=2#forms
Tech Transfer: Commercialization
• Diligence with specific dates.
• Annual progress reports.
• Ability to terminate if licensee
isn’t being diligent.
• Audit rights.
Tech Transfer: Royalties
AUTM U.S. Licensing
Activity Survey FY2012
Stanford OTL’s Process
Other Approaches
• Sponsored Research
• Minnesota: sponsored research agreement with preset licensing terms (one time fee of >10% of research funding or $15K, 1% ER after $20M sales)
• Auctions
• USC: $7.7M one time upfront fee for 11 digital multimedia patents
• Penn State: no broker, ~60 portfolios in acoustic, fuel cells and sensors, 2 sales and more pending, lots of publicity and input on older patents
• Express Licenses
• Univ of North Carolina: for UNC start ups favorable terms of 1% ER on FDA approved products, otherwise 2%. 0.75% at liquidation.
Thank You
Sara Nakashima
1705 El Camino Real
Palo Alto, California
United States
650 725 9115
Come Visit!
Resources
http://otl.stanford.edu/docume
nts/OTLstartupguide.pdf
otl.stanford.edu
www.autm.net
Biodesign book
Stanford Resources
iFarm
Stanford Inventions
• 1970 – OTL Established
• 1971 – FM Sound Synthesis ($22.9M)
• 1974 – Recombinant DNA ($255M)
• 1981 – Phycobiliproteins ($46.4M), Fiber Optic Amplifier ($48.4M), MINOS ($4.2M)
• 1984 – Functional Antibodies ($425.7M)
• 1987 – Selective Amplification of Polynucleotides ($28.1M)
• 1990-1992 – Discrete Multi-tone technologies for DSL ($29.7M)
• 1993 – Microarrays ($2.1M), MIMO for Wireless Broadcast ($1.6M)
• 1994 – In vivo Bioluminescent Imaging ($9.4M)
• 1996 – Improved Hypertext Searching - GoogleTM ($339.2M)
• 2001-2003 – Data Visualization Software
• 2004 – Refocus Photography ($324.6K)
• 2014 – the next big thing ???
*over 40+ years and 10,000
invention disclosures