Technology Technology Transfer: Transfer:

The NIH ExperienceThe NIH ExperienceSteven M. Ferguson, CLP

Deputy Director, Licensing & Entrepreneurship

Email: sf8h@nih.gov

Office of Technology TransferNational Institutes of Health

U.S. Department of Health & Human ServicesNIH Office of Technology Transfer

Science. Ideas. Breakthroughs.

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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

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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

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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

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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

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Global Perspective for Health Global Perspective for Health Research & Technology Transfer Research & Technology Transfer

at Federal Labsat Federal Labs

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• 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

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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

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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

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• 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

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Technology Transfer at Federal Technology Transfer at Federal Intramural LabsIntramural Labs

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•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

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NIH/FDA Intramural Portfolios NIH/FDA Intramural Portfolios (FY-2009)(FY-2009)

NIH Office of Technology Transfer

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• 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

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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

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• 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

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• 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

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NIH Licensed ProductsNIH Licensed Products

Vaccines• Certiva®• Cervarix®• Gardasil®• Havrix®

• Hepatyrix®• LYMErix™• RotaShield®• Twinrix®

NIH Office of Technology Transfer

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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®

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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

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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

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Examples of Products Examples of Products Developed Under NIH CRADAsDeveloped Under NIH CRADAs

NIH Office of Technology Transfer

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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

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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/

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For Additional Information on For Additional Information on NIH and OTTNIH and OTT

• NIHhttp://www.nih.gov

• OTThttp://www.ott.nih.gov

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