University Technology Transfer (USA) Success Stories

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© R. Pozner, 2010

Development and

Commercialization of U.S.

University Research

Robert Pozner, Ph.D.

Beamish Development rijsba@gmail.com

At TUC: contact through Prof. A. Dollas (37228)

13 October 2010

U.S. Government Funding of University

Research (2009)

NIH research support at U.S. universities, medical schools, research institutions, independent hospitals and nonprofits:

$21.48B; 50,033 awards

Additional $4.82B in funding for 12,786 awards through

American Recovery and Reinvestment Act of 2009 http://report.nih.gov/award/organizations.cfm?ot=&fy=2009&state=US&ic=&fm=&orgid=

NSF U.S. university research support

$5.67B; 21,512 awards http://dellweb.bfa.nsf.gov/AwdLst2/default.asp

Total funding: $31.97B

Total awards: 84,331

U.S. University T2 data (2008)

648 new commercial products introduced

5,039 total license and options executed

595 new companies formed about 72 percent of new companies formed with the primary place of business in the institution’s home state

3,381 startup companies still operating as of the end of FY2008

$51.47 billion total sponsored research expenditures

(U.S Government plus other sources)

Source: Association of University Technology Managers (AUTM) Survey (2008)

Why is Development and

Commercialization Relevant?

University objectives

Create and disseminate knowledge

Contribute to improving quality of life and economic growth

Development and commercialization can support mission for some research outcomes (5-10%)

Alternate distribution channel for knowledge created

Other channels include: teaching, publications, open source,

Creative Commons ( http:/creativecommons.org

)

When Does This Make Sense?

Knowledge has commercial (financial) potential

Potential for intellectual property (IP) protection

Significant investment required to develop and bring to market (for public benefit)

Software - exception

Opportunity to attract research funding

Stakeholders

Inventors

University (owns IP)

Corporate partners and investors

Government

As funding source

As driver for economic development

Social benefit

What are the incentives?

1. Inventors

Professors

$

Fame & fortune

Opportunity to move early research forward

Entrepreneurial interest

COI

Students

Jobs

$

Entrepreneurial interest

What are the motivations?

2. University

Distribute knowledge

Social benefit (improve quality of life)

New source of research funds (incl. overhead)

Economic development – new company formation (local), job creation

Attract and retain faculty

Generate discretionary income if successful commercialization ( <10% )

Recognition/reputation

What are the incentives?

3. Companies and investors

Companies and investors

Increase revenue and profits

Access to new technologies

Strengthen existing market positions

Develop new market opportunities

Lower production costs

Limit competition

Reduced development risk, cost

Specialized equipment, facilities

Relationships with university, professors

New breed of “Social Investors”

Green Tech

What are the incentives?

4. Government

Value for taxpayer investment in basic research at universities

New technologies for improving quality of life

Economic development

Job creation

Taxes – corporate, individual

Reduce unemployment burden

Infrastructure Supporting University

Technology Transfer (1)

Holistic – all pieces in place … now

Legal

Bayh-Dole Act (1980)

Non-profit research organizations and small businesses own IP created under U.S. Government funding

Must make effort to commercialize

Inventors share in any income from commercialization

U.S. Government rights

Infrastructure Supporting University

Technology Transfer (2)

University attitudes, policies and resources

Own (almost) all inventions (undergraduate … except …)

Investment in IP and reduction to practice

Acceptable activity – with research and teaching

Consistent with institutional objective: creation and dissemination of knowledge

COI

Publication

Use of University facilities and resources, incl. students

Infrastructure Supporting University

Technology Transfer (3)

Investment

All stages

Pre-seed/proof-of-concept, seed (“Valley of Death”), angel, VC

Business expertise and experience

Entrepreneurs

IP management and business development

Trained workers

“Knowledge Economy” - Product development, production, business, legal

Mentoring, networking

IP not owned by Universities

Contractually obligated

Facilities use agreement, Consulting agreements,

MTA

Made on own time without (significant) use of

University resources or funding

Undergraduates

Mosaic  Netscape

Marc Andressen – Univ. of Illinois National Center for

Supercomputing Applications

Browser graphical interface, inclusion of images, hyperlinks

PC and Mac versions (vs. UNIX)

Policies, plans and procedures (1)

Ownership

You can’t transfer what you don’t own

Disclosure forms

Inventors

Funding

Invention description and applications

Prior art

Invention reporting to sponsors

COI

Policies, plans and procedures (2)

Triage

Informed decisions for investment (IP, T2 resources)

Inventor relationships

INVEST OR RELEASE

Attorney selection

Technical expertise

Billing rate/cost management

Project management

Income distribution

Development and commercialization pathways

Public domain

 publications, open source, Creative

Commons, GNU GPL

Sponsored research agreement/option

Single company

Multiple companies (research centers)

License to existing company

Start-up

IP transferred through license agreement

What constitutes “success”?

Research results and ideas generated by university technical staff are nascent

Science vs. technology

Very high risks

Technology

Financial

Market

Often stepped development and investment

Driven by market opportunity, technology and business development requirements, resource requirements and availability

Successful outcomes for

Universities and inventors

No interest from “market” (potential licensees and/or investors)

Feedback

Does not reduce scientific value or legitimacy

May provide direction for future research

Increase understanding of what is commercially interesting

Interest

SRA/option/consulting

License to existing company (with/without SRA)

Form new company

What makes a good partnership

(win-win transactions)

Parties get their needs met

Critical issues identified

“Satisfice” rather than maximize

 multiple objectives

Communication

Before the deal

During negotiations

After the deal is done

Good faith

License Agreements

License vs. assignment

“In the Public Interest: Nine Points to Consider in Licensing

University Technology” (2007)

1. Universities should reserve the right to practice licensed inventions and to allow other non-profit and governmental organizations to do so

2. Exclusive licenses should be structured in a manner that encourages technology development and use

4. Universities should anticipate and help to manage technology transfer related conflicts of interest

9. Consider including provisions that address unmet needs, such as those of neglected patient populations or geographic areas, giving particular attention to improved therapeutics, diagnostics and agricultural technologies for the developing world

Success stories

Better World Project (2006 -2009+)

 http://www.betterworldproject.org/reports.cfm

University of Florida: Gatorade

Know-how license (no patents) to existing company

Wake Forest University: vacuum assisted wound closure

Patent portfolio – license to existing company

UNC Chapel Hill: gene therapy vectors

Patent portfolio – Asklepios BioPharmaceutical (start-up company, non-traditional funding )

NC State University: SiC/GaN devices and process technology

Patent portfolio – Cree Research ( start-up company)

Gatorade

®

University of Florida (“Gators”) Sports Physiology

Football players suffering heat-related injuries and problems

Fluids and electrolytes the lost through sweat , and carbohydrates used for energy were not being replaced

Scientifically formulated a new, precisely balanced carbohydrate-electrolyte beverage – Gatorade ®

Players were better able to deal with heat during practice and games; started winning more games

Inventors deal with Stokley-Van Kamp – eventually acquired by Pepsico

Ownership dispute – lawsuit

University gets 20% of sales - $100MM from 1972 until 2004

U.S. Government required publication of formula to foster competition

Gatorade ® is currently available in 80 countries; more than 30 flavors available in the U.S.; more than 50 flavors available internationally.

Vacuum Assisted Closure (VAC) of wounds

Wake Forest University School of Medicine

Negative pressure and sealed bandage

Wounds heal 50% faster

Licensed to Kinetic Concepts, Inc. (KCI) in 1993

Commercial launch of VAC Therapy System in 2005

2008 market size: ~$4.5B; KCI 9month revenue: $1.4B

Wake Forest received between $70MM and $90MM in royalties

5 patent infringement lawsuits, validity challenges in U.S.

Germany

Gene therapy vectors

Correction of single gene defect (mutation)

Delivery of payload without disruption of cell membrane

Viral vectors

Some genes too large to insert in viruses

UNC Gene Therapy Center developed hybrid (“chimeric”) viruses capable of carrying larger payloads

Asklepios BioPharmaceutical spun out of university ~2004

Targeted Duchenne Muscular Dystrophy – mutation of gene on X chromosome (males)

Symptoms (due to death of muscle fibers) < age 5

Average life expectancy: late teens to mid twenties

Treatment consists of managing symptoms

Funded by MDA (non-profit organization)

Currently in clinical trials

Facilities use agreement with UNC

Wide bandgap semiconductors

Formed in 1987 as Cree Research by grad students from the laboratory of Dr. Robert Davis at NCSU

Wide bandgap semiconductor materials (SiC), processes and structures

Application in semiconductor devices for high RF, high temp, high voltage applications

U.S. Government funded research  IP owned by

NCSU

Cree, Inc.

IP and Technology Transfer

Patent applications

Owned and filed by NCSU

Cost reimbursed by Cree under license agreement

License agreement

Exclusive rights – worldwide, all fields of use

Right to sublicense

Equity (shares of company)

Royalties on sales of products

Other U&C terms, including development and commercialization milestones

Cree, The Early Years

F&F seed funding

Develop process technology to produce 3” boules of defectfree SiC

Sold wafers for research to universities and corporate research labs

R&D to increase boule diameter (economics) and develop devices for U.S. Government customers (funded by U.S.

Government)

Reduced risk for private investment

Raise first round of funding

Cree sees the light

LEDs

SiC as substrate for GaN LEDs

Low energy consumption, long life

Tailor color of emitted light by doping and epitaxial coatings

Displays (cellphones, arenas)

Blue, green

***Consumer and commercial lighting***

White!

Approximately 2% of worldwide lighting market now LED

Cree today

www.cree.com

FY 2010 revenue: $867.3MM US (+53% year-to-year)

FY 2010 net income: $152MM (+402%)

4Q 2010 revenue: $264MM (+79%)

LED products: $240MM

RF products: $24MM

4Q 2010 net income: $52.8MM (+445%)

Market capitalization: $5.7B

Operations in USA (NC and CA), China, Hong Kong

Total employees worldwide: 4,300

Source: Cree 2010 Annual Report

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