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Technology Transfer: The NIH Experience Steven M. Ferguson, CLP Deputy Director, Licensing &...
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Transcript of Technology Transfer: The NIH Experience Steven M. Ferguson, CLP Deputy Director, Licensing &...
Technology Technology Transfer: Transfer:
The NIH ExperienceThe NIH ExperienceSteven M. Ferguson, CLP
Deputy Director, Licensing & Entrepreneurship
Email: [email protected]
Office of Technology TransferNational Institutes of Health
U.S. Department of Health & Human ServicesNIH Office of Technology Transfer
Science. Ideas. Breakthroughs.
1
What Does This Mean?
Movement of information, materials, and technologies from the research laboratories to the commercial enterprise
To support further research and develop new products to improve public health
Technology TransferTechnology Transfer
NIH Office of Technology Transfer
2Science. Ideas. Breakthroughs.
Technology Transfer Supports Technology Transfer Supports Agency MissionAgency Mission
NIH Mission:To uncover new knowledge that will lead to improved
public health
NIH Office of Technology Transfer
3Science. Ideas. Breakthroughs.
Basic Biomedical Research in Support of the Public Health
• Funding• Training• Basic Research• Clinical Trials• Inventions• Policies
National Institutes of HealthNational Institutes of Health
NIH Office of Technology Transfer
4Science. Ideas. Breakthroughs.
Engine for Research and Innovation
• Premier biomedical research institution in the United States
• 2009 Annual Budget: $30.5 billion• Basic & clinical research discoveries • Partners commercialize into products
National Institutes of HealthNational Institutes of Health
NIH Office of Technology Transfer
5Science. Ideas. Breakthroughs.
Global Perspective for Health Global Perspective for Health Research & Technology Transfer Research & Technology Transfer
at Federal Labsat Federal Labs
NIH Office of Technology Transfer
6
• Humanitarian ObjectivesHumanitarian Objectives• Globalization of Health Problems Globalization of Health Problems
and Their Relevance to Domestic and Their Relevance to Domestic HealthHealth
• Economic Development and Economic Development and Political StabilityPolitical Stability
Science. Ideas. Breakthroughs.
Supporting Research Worldwide
• Over 80% of the NIH budget• Over 50,000 awards annually• 325,000 extramural researchers (mostly universities)• Over 3,000 research organizations
Extramural ResearchExtramural Research
NIH Office of Technology Transfer
7Science. Ideas. Breakthroughs.
Intramural ResearchIntramural Research
Biomedical Research and Training
• Approximately 10 % of NIH budget
• More than 2,000 active projects• More than 6,000 scientists• Collaborative research• Patent/License technologies
NIH Office of Technology Transfer
8Science. Ideas. Breakthroughs.
Development and Transfer Activity
• Intramural Research (from the NIH Office of Technology Transfer)
• University Grantee Research (from University Grantee Research (from specific university technology specific university technology transfer offices)transfer offices)
• SBIR and STTR Programs (from SBIR and STTR Programs (from small business awardees)small business awardees)
Future Commercial Products Future Commercial Products Licensable From Several Licensable From Several
SourcesSources
NIH Office of Technology Transfer
9Science. Ideas. Breakthroughs.
• Benefit the public health & well-being
• Utilize IPR appropriately as incentive for commercial development of technologies
• Attract new R&D resources
• Obtain return on public investment
• Stimulate economic development
Goals For Federal Intramural Goals For Federal Intramural Technology TransferTechnology Transfer
NIH Office of Technology Transfer
10Science. Ideas. Breakthroughs.
Technology Transfer at Federal Technology Transfer at Federal Intramural LabsIntramural Labs
NIH Office of Technology Transfer
11Science. Ideas. Breakthroughs.
•Evaluate inventions for patenting•Work closely with inventors•Manage patent & invention portfolio•Identify commercial partners & negotiate licenses & collaboration agreements•Manage relationships with commercial partners
• Novel, fundamental research discoveries
• Research tools• CRADA partnerships for basic or
clinical studies• Selected products in early clinical
studies• Licensees do nearly $6 billion
annually in sales
Characteristics of the NIH Characteristics of the NIH Intramural Research Program Intramural Research Program
“Pipeline”“Pipeline”
NIH Office of Technology Transfer
12Science. Ideas. Breakthroughs.
NIH/FDA Intramural Portfolios NIH/FDA Intramural Portfolios (FY-2009)(FY-2009)
NIH Office of Technology Transfer
13Science. Ideas. Breakthroughs.
• 353 invention disclosures
• 110 U.S. patents issued
• 215 licenses executed
• 1,400+ active licenses
• $91.2 million in royalties collected
• 77 CRADAs executed (NIH only)
• 365 active CRADAs (NIH only)
• ~600 products developed to date (25 FDA approved)
• $1B in royalties collected to date
NIH Office of Technology Transfer
14Science. Ideas. Breakthroughs.
NIH/FDA Intramural Portfolios NIH/FDA Intramural Portfolios (FY-2009)(FY-2009)
Seek patent protection if:• facilitates availability of the technology for
preventive, diagnostic, therapeutic, or other commercial use
• further research and development is necessary to realize the technology’s primary use
• commercial or public health value of the technology warrants the expenditure of funds
• research has a practical utility or a reasonable expectation of future practical utility
Do not seek patent protection if:• Commercialization and technology transfer can best
be accomplished without patent protection
NIH Patenting PrinciplesNIH Patenting Principles
NIH Office of Technology Transfer
15Science. Ideas. Breakthroughs.
• Granting only the appropriate scope of rights
• Permit research uses• Preference for non- or partial exclusivity• Specified fields of use• Enforceable milestones and benchmarks• Maximize development of products for
the public health• Ensure appropriate return on public
investment
NIH Product Licensing PrinciplesNIH Product Licensing Principles
NIH Office of Technology Transfer
16Science. Ideas. Breakthroughs.
• Synagis®• Taxol®• Velcade®• Videx®• Vitravene®• Zenapax®• Zevalin®
Therapeutics• Didanosine• Fludara®• Hivid®• Kepivance®• NeuTrexin®• Prezista®• Sporanax®
NIH Licensed ProductsNIH Licensed Products
NIH Office of Technology Transfer
17Science. Ideas. Breakthroughs.
NIH Licensed ProductsNIH Licensed Products
Vaccines• Certiva®• Cervarix®• Gardasil®• Havrix®
• Hepatyrix®• LYMErix™• RotaShield®• Twinrix®
NIH Office of Technology Transfer
18Science. Ideas. Breakthroughs.
Diagnostics• AcuTect®• BRACAnalysis®• HIV Test Kits• NeoTect®
NIH Licensed ProductsNIH Licensed Products
• Parvovirus B19 Immunoassay
• PathVysion® HER-2 DNA Probe Kit
• Pathway® Her-2/neu (4B5)
• Thyrogen®
NIH Office of Technology Transfer
19Science. Ideas. Breakthroughs.
NIH Licensed ProductsNIH Licensed Products
Consumer Products
Devices/Instrumentation/Software
Research Reagents
Veterinary Products
We invite you to view the Product Showcase at our website to learn more about these licensed products, as well as many others not listed in the preceding slides. Look for this icon on our homepage.
NIH Office of Technology Transfer
20Science. Ideas. Breakthroughs.
Collaboration between Government lab and outside party
• Government provides expertise, equipment, materials• Collaborator provides same and possibly money• Provides Collaborator with right to elect option to exclusive license to new inventions
CRADA – Cooperative Research CRADA – Cooperative Research and Development Agreementand Development Agreement
NIH Office of Technology Transfer
21Science. Ideas. Breakthroughs.
Examples of Products Examples of Products Developed Under NIH CRADAsDeveloped Under NIH CRADAs
NIH Office of Technology Transfer
22Science. Ideas. Breakthroughs.
NIH Marketing EffortsNIH Marketing Efforts
• OTT Licensing Opportunities
– Searchable databasehttp://www.ott.nih.gov/search
– Technologies RSS Feedhttp://www.ott.nih.gov/rss
– Federal Registerhttp://www.gpoaccess.gov/fr/advanced.html
• CRADA Opportunities RSS Feedhttp://www.ott.nih.gov/rss/cradarss.xml
NIH Office of Technology Transfer
23Science. Ideas. Breakthroughs.
NIH Marketing EffortsNIH Marketing Efforts
• Interactive Technology Transfer Metricshttp://www.ott.nih.gov/ttmetrics/
• NIH Lights Up The Worldhttp://www.ott.nih.gov/gis/
• Pipeline to Partnerships (P2P)http://www.ott.nih.gov/p2p/
• Product Development Pipelinehttp://www.ott.nih.gov/productpipeline/
• Product Showcasehttp://www.ott.nih.gov/productshowcase/
NIH Office of Technology Transfer
24Science. Ideas. Breakthroughs.
For Additional Information on For Additional Information on NIH and OTTNIH and OTT
• NIHhttp://www.nih.gov
• OTThttp://www.ott.nih.gov
NIH Office of Technology Transfer
25Science. Ideas. Breakthroughs.