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Technology Transfer: theNIH Experience
Technology Transfer: theNIH Experience
Mark Rohrbaugh, Ph.D., J.D.Director
Richard Rodriguez, M.B.A.Director, Division of Technology Development & Transfer
Office of Technology TransferNational Institutes of HealthU.S. Department of Health & Human Services
Technology Transfer Tactics WebinarDecember 8, 2009
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Overview
NIH/OTT
Collaborations
Success stories
Patenting & Licensing
Marketing resources
Monitoring & enforcement
Q & A
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CSR
NCMHD
NIGMS
NLM
FIC
NCCAM
NIBIB
The National Institutes of Health27 Institutes and Centers
NIDCD NHGRI
NHLBI
NIDCR
NINR
NINDS
NEI
NCI
NIA
NIMH
NIAID
NIDA
NIEHS
NIDDK
NIAMS
NIAAA
CC
NICHD
NCRR
CIT
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Extramural Research
Long tradition of interaction between Government, Academia, and Industry
Over 80% of the NIH budget
Over 50,000 awards annually
325,000 extramural researchers (mostly universities)
Over 3,000 research organizations
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Intramural Research
Approximately 9% of NIH Budget
More than 2,000 active projects
More than 6,000 doctoral level scientists
Breakthrough Technologies/Therapies
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NIH Collaborations
Negotiated by NIH Institutes Cooperative research and development
agreements (CRADA) Material transfer agreements (MTA) Clinical trial agreements (CTA)
Negotiated by OTT Non-exclusive/exclusive licenses
Internal and commercial uses Patented and unpatented IP
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Cooperative Research and Development Agreements (CRADAs)
Agreement envisions two-way exchange of resources, information and intellectual property
Collaboration between Government lab and outside party
Government provides expertise, equipment, materials (no money)
Collaborator provides same and possibly money
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CRADAs cont.
CRADAs cannot direct or restrict research in a NIH laboratory
Brief delays in dissemination of research results are permitted
Subject inventions created under CRADA can be solely owned by either party or jointly owned
Option for non-exclusive or exclusive license
CRADA research plan
Government retains use license
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Combination discovery
Taxol® and stents 1993
Patents filed 1996-2002
License 1996 Angiotech
Angiotech and NIH CRADA 1996
Sublicenses 1998-99 Boston Scientific
FDA approval 2004Patents issued 1997,2002
70% market in 1 month!
Examples of Products Developed Under NIH CRADAs
Product Company Use
FluMist® MedImmune Influenza vaccine
Havrix® GlaxoSmithKline Vaccine against hepatitis A
Taxol® Bristol-Myers Squibb Treatment of solid tumor cancers and Kaposi's sarcoma
Taxus® Express
Boston Scientific Treatment of coronary artery disease
(drug-eluting stent)
Thyrogen® Genzyme
Therapeutics
Adjunct to thyroid cancer treatment
Velcade® Millennium Pharmaceuticals, Inc.
Treatment of multiple myeloma
FY08 PRODUCTS253 total
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Centralized Technology Transfer
Policy
Invention
Evaluation
Patenting
MarketingLicensing
Monitoring &
Enforcement
Royalty
Administration
Office of Technology Transfer
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Decentralized Technology Transfer
Technology Development
Center
Office of Technology Transfer (OTT)
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Patentability Issues
Contract law firms
Public disclosures
Coordination with NIH institutes Large vs. small institutes
Collaborations
Information flow
IP database
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Patent Policy Seek patent protection if:
Realize the technology’s primary use
Preventive, diagnostic, therapeutic
Commercial or public health value
Practical utility
Do not seek patent protection if: Technology transfer can best be
accomplished without patent protection
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Organizational Structure
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Licensing Goals
Promote public health Bench to bedside: product development
Aggressively market technology
Identify “best” commercial partner
Negotiate appropriate agreement
Support programmatic goals
Economic development
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NIH Licensing Principles
Preference for non or partial exclusivity Promote competition and access ~15% exclusive agreements
Detailed Commercial Development Plan No defensive licenses
Grant only the appropriate scope of rights Define product Specific fields of use Licensed territory becoming more important
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License Principles cont.
Permit research uses Exclusive agreements
Academic or corporate
Enforceable benchmarks
Monitor agreements (at least annual)
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FY09 License Data
375 applications received (~400/yr)
215 licenses executed
44% small business vs. 38% large business
82% US firms NIH does license to foreign firms
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Global License Data(1987-2009)
1,400+ active licenses
More than 400 products (including research tools) on the market 25 FDA approved 84 more in in clinical development
$950M in royalties collected
$5-6B annually in products sales by companies
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Large vs. Small Firms
Types of agreements
Size does matter Large firms more willing to walk away
Small firms cash-strapped
Momentum
Efficiency
At the end of the day…
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US vs. Non-US Firms
Getting the message out there
Best partner is key goal
All things being equal
Special provisions/requirements US manufacturing provisions
Share model agreements early
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Licensing Keys to Success
State clear goals
Communicate early and often
Internal organizational structure
Buy-in from stakeholders
Be flexible/current events
Database and management controls
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NIH Marketing Efforts
OTT Product Showcase http://www.ott.nih.gov/productshowcase/
OTT Licensing Opportunities OTT Searchable database
http://www.ott.nih.gov/Technologies/AbsSearchBox.aspx
Federal Register http://www.gpoaccess.gov/fr/advanced.html
NIH Listserve http://www.ott.nih.gov/ott_listserv/join_ott.aspx
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Specialized Marketing Efforts
Synapse™: Technology matching tool Contact Ajoy Prabhu: aprabhu@mail.nih.gov
Pipeline to Partnerships (P2P): virtual space to showcase technology and product development
http://www.ott.nih.gov/p2p
Rare Diseases and Conditions Page: technologies related to rare diseases or conditions
http://www.ott.nih.gov/rarediseases
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Monitoring & Enforcement
Post-execution monitoring criticalto successful licensing program
NIH has dedicated unit to monitorand enforce its agreements
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What is It Reviewing licenses & identifying
obligations Collecting overdue royalty payments Reviewing reports – progress, annual,
sales Addressing other non-compliance issues Settling license disputes Performing/managing royalty audits Identifying and settling patent
infringements
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Why Do It?
Verify that PHS technology is used or developed
Verify that royalties owed are paid
Identify unlicensed technology users
Increase overall royalties collected
Assure licensees are treated fairly
Assure inventors are treated fairly
Assure license records are up-to-date
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Options for Compliance
Inform/educate licensee of their obligation(s) Set deadlines for receipt of royalties/reports
owed Threaten or impose “additional royalties” Suspend other licensing until owed royalties
are paid Threaten with debt collection, credit bureau
reporting, & excluded parties listing Negotiate amendment to restore
compliance/settle dispute Notice of license termination
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Other Monitoring Functions
Evaluate requests for consent to sublicense Evaluate requests for consent to assign
license Evaluate requests for waiver of U.S. mfr
requirement Negotiate amendments – term extension &
other Identify licenses for audit, manage audit,
negotiate settlement Investigate infringement cases, pursue
licensing
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Resources Used in Monitoring
TechTracS Database Communication with licensee (phone / e-mail /
letter) Reports submitted by licensees Press releases, information on company web
sites, SEC filings, etc. Information provided by licensees or inventors Legal advice from NIH Office of General
Counsel U.S. Attorney’s Office located near licensee
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Impact of Monitoring Efforts
Total FY2008 Royalty Collections for NIH = $92 million
Monitoring & Enforcement efforts brought in :
$1.5 million in collection of overdue royalties $396,206 from new agreements & settlements $40,838 from 3rd party audits
= $1.95 million (2.1% of total FY08 royalties)
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Thanks&
Q&A
Mark Rohrbaugh, Ph.D., J.D.rohrbaum@mail.nih.gov301-594-7700
Richard Rodriguez, M.B.A.rodrigr@mail.nih.gov301-435-4013
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