IP Evaluation for Early Stage Technology

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IP Evaluation for Early Stage Technology
BIO BOOT CAMP June 2007

• David N. Allen, Ph.D.
• Associate Vice President for Technology Transfer
• University of Colorado
• david.allen_at_CU.edu
• 303 735 1688

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• Technologythe Ideal
• The inventor developed a product in the context
  of a market problem
• Proof of concept work is done
• Infrastructure in place to exploit technology
• The commercial partner in is the queue
• Technologythe Reality
• The inventor pushed the envelop of science and
  independent of any specific market problem
• Product has not been defined or conceived
• Data directed at publication and next grant
  cycle
• Lack of infrastructure for revolutionary
  advances

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The CU TTO Technology Assessment/Protection
Process
Internal processing
Receive disclosure
Data incomplete- On Hold
Accept disclosure
Create case add to database
Assign manager
Internal Analysis
Release rights to inventor
Notification of other owners
Rights Determination
Review of Related contracts
Agreement clarifying rights
Commercial feasibility analysis
Legal
Market
IP
Technical
Release rights to inventor
4 months
Business plan
Management
IP Terms
Startup -or - licensing
Patent Filing
Advise Inventor (s) of commercial plan
Marketing
Negotiation
Interest?
Yes
External Development
No
Release rights to inventor
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Receive and review the invention disclosure

• Seek to understand the technology
• Assess patentability
• - Newness (novelty)
• - Non-obviousness
• - Usefulness (utility)
• Assess development needs and current stage
• Seek expert opinions
• Search for public disclosures and prior art
• Assess rights obligations

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First inventor interview obtain preliminary
perspectives

• Discuss the technology (review experimental
  data)
• Discuss patentability and patent process
• Possible applications and marketability
• Inventor perspective of benefits
• Inventors industry contacts
• Discuss inventors resources
• Discuss commitment to technology validation
• Discuss pending publications, collaborations,
  etc
• Discuss next steps and timing

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The CU TTO Technology Assessment/Protection
Process
Internal processing
Receive disclosure
Data incomplete- On Hold
Accept disclosure
Create case add to database
Assign manager
Internal Analysis
Release rights to inventor
Notification of other owners
Rights Determination
Review of Related contracts
Agreement clarifying rights
Commercial feasibility analysis
Legal
Market
IP
Technical
Release rights to inventor
4 months
Business plan
Management
IP Terms
Startup -or - licensing
Patent Filing
Advise Inventor (s) of commercial plan
Marketing
Negotiation
Interest?
Yes
External Development
No
Release rights to inventor
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Commercial feasibility analysis

• Basic Questions - What does it do and how do you
  make money?
• What is the problem to be solved?
• How does the technology solve it?
• What are the alternatives/competition?
• How is the technology better than alternatives?
• What is the value proposition for the product
  replacement and benefit economics? Some call
  this the pain threshold, what pain will it
  cause a competitor and relief to a user?
• How do you extract economic value for the
  pain/benefit, i.e., what are the transaction
  points where value is attributed and exchanged?

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The CU TTO Technology Assessment/Protection
Process
Internal processing
Receive disclosure
Data incomplete- On Hold
Accept disclosure
Create case add to database
Assign manager
Internal Analysis
Release rights to inventor
Notification of other owners
Rights Determination
Review of Related contracts
Agreement clarifying rights
Commercial feasibility analysis
Legal
Market
IP
Technical
Release rights to inventor
4 months
Business plan
Management
IP Terms
Startup -or - licensing
Patent Filing
Advise Inventor (s) of commercial plan
Marketing
Negotiation
Interest?
Yes
External Development
No
Release rights to inventor
9
Legal analysis

• Are there legal constraints?
• Ownership, pre-existing obligations
• Regulatory pathway
• Healthcare policy issues
• Reimbursement issues
• Government rights
• Disclosure obligation of the University
• Publication rights

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The CU TTO Technology Assessment/Protection
Process
Internal processing
Receive disclosure
Data incomplete- On Hold
Accept disclosure
Create case add to database
Assign manager
Internal Analysis
Release rights to inventor
Notification of other owners
Rights Determination
Review of Related contracts
Agreement clarifying rights
Commercial feasibility analysis
Legal
Market
IP
Technical
Release rights to inventor
4 months
Business plan
Management
IP Terms
Startup -or - licensing
Patent Filing
Advise Inventor (s) of commercial plan
Marketing
Negotiation
Interest?
Yes
External Development
No
Release rights to inventor
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Market analysis

• Is there a market?
• Who is the customer
• Market drivers (revisit the pain issue)
• Epidemiology, incidence, prevalence
• Reimbursement by third-party payers, validated
  payer
• Demographics/trends
• Competitive landscape and pipeline

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The CU TTO Technology Assessment/Protection
Process
Internal processing
Receive disclosure
Data incomplete- On Hold
Accept disclosure
Create case add to database
Assign manager
Internal Analysis
Release rights to inventor
Notification of other owners
Rights Determination
Review of Related contracts
Agreement clarifying rights
Commercial feasibility analysis
Legal
Market
IP
Technical
Release rights to inventor
4 months
Business plan
Management
IP Terms
Startup -or - licensing
Patent Filing
Advise Inventor (s) of commercial plan
Marketing
Negotiation
Interest?
Yes
External Development
No
Release rights to inventor
13
IP analysis

• Are there patent constraints?
• Publications by inventor
• Prior art (by other investigators)
• Patentability
• Enforceability
• Freedom to operate
• Freedom to exclude

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IP position analysis

• Obviousness
• Licensing - exclusivity, sublicensing,
• payment model
• Fields of use
• Geographical distinctions
• Ability to design around the claims
• Can you prove infringement?

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The CU TTO Technology Assessment/Protection
Process
Internal processing
Receive disclosure
Data incomplete- On Hold
Accept disclosure
Create case add to database
Assign manager
Internal Analysis
Release rights to inventor
Notification of other owners
Rights Determination
Review of Related contracts
Agreement clarifying rights
Commercial feasibility analysis
Legal
Market
IP
Technical
Release rights to inventor
4 months
Business plan
Management
IP Terms
Startup -or - licensing
Patent Filing
Advise Inventor (s) of commercial plan
Marketing
Negotiation
Interest?
Yes
External Development
No
Release rights to inventor
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Technical analysis

• What are the technical risks?
• Stage of development and overall timeframe
• Is the technology validated?
• Is the product validated?
• What can go wrong what is necessary for it to
  go right?
• Is the inventor funded?
• Is the inventor interested in the development
  work?
• How to fund development?

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The CU TTO Technology Assessment/Protection
Process
Internal processing
Receive disclosure
Data incomplete- On Hold
Accept disclosure
Create case add to database
Assign manager
Internal Analysis
Release rights to inventor
Notification of other owners
Rights Determination
Review of Related contracts
Agreement clarifying rights
Commercial feasibility analysis
Legal
Market
IP
Technical
Release rights to inventor
4 months
Business plan
Management
IP Terms
Startup -or - licensing
Patent Filing
Advise Inventor (s) of commercial plan
Marketing
Negotiation
Interest?
Yes
External Development
No
Release rights to inventor
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Basic licensing models

• Product IP
• Typically exclusive, rarely a start-up
• Platform IP
• Start-up or existing company, sometimes divided
  uses
• Process IP
• Often nonexclusive to existing companies
• Research tool IP
• Typically non-exclusive for broad use

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The CU TTO Technology Assessment/Protection
Process
Internal processing
Receive disclosure
Data incomplete- On Hold
Accept disclosure
Create case add to database
Assign manager
Internal Analysis
Release rights to inventor
Notification of other owners
Rights Determination
Review of Related contracts
Agreement clarifying rights
Commercial feasibility analysis
Legal
Market
IP
Technical
Release rights to inventor
4 months
Business plan
Management
IP Terms
Startup -or - licensing
Patent Filing
Advise Inventor (s) of commercial plan
Marketing
Negotiation
Interest?
Yes
External Development
No
Release rights to inventor
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Patent costs

• Simple, mechanical application 8-12k
• Complex chemical or software 20-25k
• Pharmaceutical 30k
• Prosecution 4k per office action
• Issue/maintenance fees for life of US patent
  1.4k 0.9k 2.3k 3.8k 8.4k

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The CU TTO Technology Assessment/Protection
Process
Internal processing
Receive disclosure
Data incomplete- On Hold
Accept disclosure
Create case add to database
Assign manager
Internal Analysis
Release rights to inventor
Notification of other owners
Rights Determination
Review of Related contracts
Agreement clarifying rights
Commercial feasibility analysis
Legal
Market
IP
Technical
Release rights to inventor
4 months
Business plan
Management
IP Terms
Startup -or - licensing
Patent Filing
Advise Inventor (s) of commercial plan
Marketing
Negotiation
Interest?
Yes
External Development
No
Release rights to inventor
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Marketing strategy

• Know the channels that fit the technology
• Look for the partners that will develop or use
  the product/technology
• Follow inventors inquiries
• Summarize the critical info
• Get in touch with the right people in the right
  company
• Publication exposure can lead to critical mass
• Seek feedback, refine the pitch

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Thank You for Listening
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