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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