Transfer of Early Stage Medical Technologies · Transfer of Early Stage Medical Technologies 2014...

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

Sara.Nakashima@stanford.edu

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