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Technology Transfer: the NIH Experience

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1 Technology Transfer: the NIH Experience
Mark Rohrbaugh, Ph.D., J.D. Director Richard Rodriguez, M.B.A. Director, Division of Technology Development & Transfer Office of Technology Transfer National Institutes of Health U.S. Department of Health & Human Services Technology Transfer Tactics Webinar December 8, 2009

2 Overview NIH/OTT Collaborations Success stories Patenting & Licensing
Marketing resources Monitoring & enforcement Q & A

3 The National Institutes of Health 27 Institutes and Centers

4 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

5 Intramural Research Approximately 9% of NIH Budget
More than 2,000 active projects More than 6,000 doctoral level scientists Breakthrough Technologies/Therapies

6 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

7 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

8 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

9 Combination discovery Taxol® and stents 1993
Patents filed License 1996 Angiotech Angiotech and NIH CRADA 1996 Sublicenses Boston Scientific Patents issued 1997,2002 FDA approval 2004 70% market in 1 month! 9

10 Examples of Products Developed Under NIH CRADAs
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

11 FY08 PRODUCTS 253 total

12 Centralized Technology Transfer

13 Decentralized Technology Transfer
Cooperative Research & Development Agreements Material Transfer Agreements Employee Invention Reports Clinical Trial Agreements Technology Development Center Office of Technology Transfer (OTT)

14 Patentability Issues Contract law firms Public disclosures
Coordination with NIH institutes Large vs. small institutes Collaborations Information flow IP database

15 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

16 Organizational Structure
Office of the Director OTT Marketing Royalties Division of Technology Development and Transfer Cancer Branch General Medicine Branch Infectious Disease and Mechanical Engineering Branch Monitoring and Enforcement Branch Service Center Branch Division of Policy

17 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

18 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

19 License Principles cont.
Permit research uses Exclusive agreements Academic or corporate Enforceable benchmarks Monitor agreements (at least annual)

20 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

21 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 

22 Large vs. Small Firms Types of agreements Size does matter Momentum
Large firms more willing to walk away Small firms cash-strapped Momentum Efficiency At the end of the day…

23 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

24 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

25 NIH Marketing Efforts OTT Product Showcase OTT Licensing Opportunities
OTT Licensing Opportunities OTT Searchable database Federal Register NIH Listserve

26 Specialized Marketing Efforts
Synapse™: Technology matching tool Contact Ajoy Prabhu: Pipeline to Partnerships (P2P): virtual space to showcase technology and product development Rare Diseases and Conditions Page: technologies related to rare diseases or conditions

27 Monitoring & Enforcement
Post-execution monitoring critical to successful licensing program NIH has dedicated unit to monitor and enforce its agreements

28 What is It Collecting overdue royalty payments
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

29 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

30 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

31 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

32 Resources Used in Monitoring
TechTracS Database Communication with licensee (phone / / 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

33 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)

34 Thanks & Q&A Mark Rohrbaugh, Ph.D., J.D. Richard Rodriguez, M.B.A.
Richard Rodriguez, M.B.A.

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