Technology Transfer Process at CU

1
Technology Transfer Process at CU
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Devices Platforms
Startups Successes Summary
Rick Silva, PhD Assistant Director Rick.Silva_at_cu.
edu
Susana Read, DVM, MBA Licensing
Associate Susana.read_at_cu.edu
Kate Tallman, MBA Assistant Director Kate.Tallman_at_
cu.edu
2
Technology
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• The ideal
• The inventor has thought about a problem in the
  context of product development for a lucrative
  market
• Proof of concept work is done
• Infrastructure in place to exploit technology
• The commercial partner in is the queue

• the blockbuster drug or the killer app

3
Technology
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• The reality
• Raw technologies
• Not directed to a market problem
• Product has not been defined or conceived
• Data directed at curiosity, publication, and
  next grant cycle
• Lack of infrastructure for revolutionary
  advances

• a solution looking for a problem

4
Technology - the gap
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• The risk gap this is not venture capital
• SBIR/STTR
• CAPCO/CVCA
• RAID and RAPID programs at NIH
• Gap funds
• Birdseed funds

5
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary
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
6
Invention disclosure
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Evidence for patent
• - Novelty
• - Non-obviousness
• - Utility
• Stage of development
• Expert opinions
• Public disclosure
• Sponsorship

7
First inventor interview
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Technical feasibility
• Patentability
• Applications and marketability
• Inventor interest and motivation
• Benefits, as inventor sees them
• Inventors industry contacts
• Future resources
• Commitment to technology validation
• Commitment to technology development
• Expectations
• Pending publications, collaborations, joint
  ownership

8
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary
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
Commercial feasibility analysis
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Basic Questions for Physical Sciences
• What does it do?
• What is the problem to be solved?
• How does the technology solve it?
• What are the alternatives? (How is the problem
  currently solved?)
• How is the technology better than alternatives?

10
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary
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
11
Legal analysis
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Are there legal constraints?
• Ownership, preexisting obligations
• Regulatory path
• Healthcare policy
• Reimbursement
• Government rights
• Disclosure obligation of the University
• Publication rights

12
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary
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
Market analysis
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

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

14
Market analysis
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Disruptive vs. incremental technology
• What does the ideal partner look like?
• Does it stand alone?
• What are the risks?
• Is the infrastructure in place?

15
Market analysis
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Physical Sciences Is it a big enough market?
• Does the problem really need to be solved?
• Are the only customers a few specialized
  University labs?

16
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary
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
17
IP position analysis
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Are there patent constraints?
• Publications
• Patentability
• Enforceability
• Freedom to operate
• Freedom to exclude
• Prior art

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IP position analysis
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Obviousness
• Licensing - exclusivity, sublicensing,
• payment model
• Fields of use
• Geographical distinctions

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IP position analysis
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Enforceability Physical Sciences
• Can you prove infringement easily?
• Is it difficult to design-around?

20
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary
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
21
Technical analysis
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Are there technical risks?
• Stage of development
• Is the technology validated?
• Is the product validated?
• What can go wrong?
• Is the inventor funded?
• Is the inventor interested in the development
  work?
• How to fund development?

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Technical analysis
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• How to fund development?
• What are the milestones/checkpoints?
• Regulatory environment
• Analytical, biological, clinical development
  needs
• Licensing - exclusivity, sublicensing, payment
  model
• Fields of use
• Geographical distinctions

23
Technical analysis
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Physical Sciences
• Is it technically sound?
• Does data exist to show it works?
• Is it far enough along in development?
• Is there a prototype?
• Any barriers to scaling-up?
• Can it be produced profitably?

24
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary
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
25
Licensing
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Product IP
• Typically exclusive, rarely a startup
• Platform IP
• Startup or existing company, sometimes divided
  uses
• Process IP
• Often nonexclusive to existing companies

26
Attracting potential licensees
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• What is the technology?
• Why is the technology useful in the
  organizations product, process, or markets?
• How mature is the technology?
• What is the value proposition?
• What do I need to use the technology? Will it
  stand alone?
• What will it cost?
• What is the net benefit?

27
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary
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
28
Patent costs
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Simple, mechanical application 8-10k
• Complex chemical or software 20-25k
• Pharmaceutical 30k
• Prosecution 4k per office action
• Issue/maintenance fees for life of patent
  1.4k 0.9k 2.3k 3.8k 8.4k

29
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary
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
30
Marketing strategy
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Know the channels that fit the technology
• Look for the partners that will develop or use
  the product/technology
• The inventors will get inquiries
• Summarize the critical info
• Get in touch with the right people
• Document marketing, show inventors the efforts
• Exposure can lead to critical mass
• Seek feedback, refine the pitch
• Make adjustments as necessary

31
Confidential Disclosure Agreements
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Used during the marketing stage
• Protect international patent rights
• Signed by a TTO Director

32
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary
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
33
Feasibility Analysis
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Will anyone buy it?
• Opportunity/need
• Product description
• Target market
• Unique benefits
• Competitive Analysis
• Can it make a profit?
• Sustainable competitive advantage
• Risks
• Profitability

34
Feasibility Analysis
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary
35
Take-home points
Introduction Capabilities Process Approaches
Biomaterials Biomarkers Targets
Therapeutics Device Platforms
Startups Successes Summary

• Take detailed notes, always ask questions
  frequently
• Dont sign anything, dont make any actionable
  decisions
• Submit written summaries and recommendations,
  decisions are made by committees - make your
  case
• Dont do everything by yourself dont reinvent
  the wheel
• Nobody is an expert in everything work as a team
• Keep all of the written resources made available
  to you
• Mistakes are easier to fix early, dont wait
• Organization is critical keep a notebook and a
  calendar
• Communicate with your mentor/licensing associate
• Read all of the TTO materials, understand our
  values
• Call your inventors, be patient with them