U.S. Technology Transfer Infrastructure and Experience

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U.S. Technology TransferInfrastructure and
Experience

• Mark Bohannon
• General Counsel VP Govt Affairs
• SIIA
• April 4, 2001

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Tech Transfer Infrastructure

• Diverse US agency mission goals
• Multi-faceted implementation by
• Industry (for profit private sector)
• University (non-profit private sector)
• Government (including Natl Labs)
• Goals of U.S. Tech Transfer Policy
• Evolution of Goals
• Legal Framework focus on IP Treatment

in fact, complex web of players
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Source National Science Foundation, Sixth Year
of Unprecedented RD Growth Expected in 2000,
November 29, 2000. See http//www.nsf.gov/sbe/sr/
.
4
Source National Science Foundation, Sixth Year
of Unprecedented RD Growth Expected in 2000,
November 29, 2000. See http//www.nsf.gov/sbe/sr/
.
5
Source National Science Foundation, Sixth Year
of Unprecedented RD Growth Expected in 2000,
November 29, 2000. See http//www.nsf.gov/sbe/sr/
.
6
Source National Science Foundation, Sixth Year
of Unprecedented RD Growth Expected in 2000,
November 29, 2000. See http//www.nsf.gov/sbe/sr/
.
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Goals Evolved

• Implementation of Tech Transfer developed in
  context of diverse Agency missions Health,
  Agriculture, Defense, Energy, Environment
• Spin off technologies pipeline theory of
  innovation
• Economic benefits from technology Job creation,
  global competitiveness
• Focus on private sector as catalyst for new
  technologies emphasis on public-private
  partnerships

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The Real Picture
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Legal Framework

• Treatment of inventions developed with USG
  financial assistance
• Treatment of inventions developed by USG
  employees
• Treatment of inventions arising out of
  collaborations with National Labs

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Bayh-Dole Pursuit of Tech Transfer

• Before 1980, USG universal policy hold title to
  all inventions arising out of USG RD investment
• Licensed only for non-exclusive uses
• Rarely licensed patent portfolio for use in
  commerce by private sector

Commercialization of Technologies arising out
of USG not occurring
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Changes brought by Bayh-Dole

• Scope Financial assistance by USG (contract,
  grant, cooperative agreement) for experimental,
  developmental or research
• Recipient may elect to hold title virtually
  always occurs
• Recipient responsibilities in exchange for taking
  title .

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Recipient of USG must

• Provide USG a nonexclusive, nontransferable,
  irrevocable, paid-up license for subject
  invention
• Provide USG, if requested, with periodic reports
  on utilization
• Include in any patent application fact of USG
  support

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• Accept march-in rights as a means of last
  resort if recipient fails to commercialize, or
  overriding governmental interests intervene.
• Condition granting of an exclusive license upon
  licensee agreeing that any products embodying or
  produced through subject invention will be
  manufactured in U.S.

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Agency Patent Licensing

• Until 1980, USG patenting and licensing processed
  confusing, at best. Bayh-Dole specified
  procedures for licensing and made it policy
  priority.
• Applicant must present plan for development or
  marketing invention.
• If exclusive, additional requirements, requires
  public notice and determination that exclusivity
  is in best interest and reasonable and
  necessary incentive. License scope must be no
  greater than reasonably necessary.

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CRADAs

• Cooperative Research Development Agreements
  created by Federal Tech Transfer Act of 1986
  for GOGOs
• Expanded in 1990 to include GOCOs
• Cost-Shared collaborations between a National
  Laboratory and private sector.
• Labs may accept use funds, personnel services,
  property from collaborator.

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CRADAs continued

• Labs may provide personnel, services property
  to collaborator. May NOT provide .
• Work under CRADA can occur at Natl Lab,
  collaborators premises or both.
• In general, decentralized decision-making on
  implementation.
• 5 year protection for confidential information
  arising out of CRADA

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Treatment of IP under CRADA

• Lab Director given authority to negotiate
  licensing agreements for inventions or other
  intellectual property
• Collaborator has option to choose exclusive
  license for pre-negotiated field of use for any
  USG invention arising under CRADA
• Government is normally granted license in any
  invention made by collaborator

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Experience?

• USG Tech Transfer policy developed in context of
  US commercial and RD environment
• Built on appropriate roles of government and
  private sector
• Goals of Tech Transfer evolved over time
  reflecting USG mission goals, economic
  environment,

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USG Tech Transfer Policy

• Required USG Agencies to incorporate Tech
  Transfer into core missions
• Streamlining agreements for in partnering with
  private sector
• Defining criteria to be used in selecting
  partners, collaborators and licensees
• Measurements of inputs, outputs still a work in
  progress