Managing Intellectual Property Assets: The NIH OTT Perspective

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1 2009/SOM1/IPEG/SEM/003 Session: 2 Managing Intellectual Property Assets: The NIH OTT Perspective Submitted by: United States From Mind to Market: The Highs and Lows of Technology Transfer Singapore February 2009

2 Managing Intellectual Property Assets: The NIH OTT Perspective Fatima Sayyid, M.H.P.M. Senior Licensing and Patenting Manager General Medicine Branch Office of Technology Transfer National Institutes of Health U.S. Department of Health & Human Services APEC-IPEG Capacity Building Seminar February 23-24, 2009 The National Institutes of Health Mission: Science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability Annual budget: ~ $28B Extramural research: over 46,000 grants and contracts awarded annually to ~ 325,000 extramural researchers in over 3,000 organizations world-wide Intramural research funding: ~ 10% Intramural scientists: ~ 6,000

3 The National Institutes of Health 27 Institutes and Centers (ICs) NLM NINR NINDS NIMH NIGMS NIEHS NIDDK NIDCR NIDCD NIDA NICHD NIBIB NIAMS CC CIT CSR FIC NCCAM NCI NCMHD NCRR NEI NHGRI NHLBI NIA NIAAA NIAID NIH Office of Technology Transfer (OTT) Mission: Improve public health through the management of NIH and FDA inventions and in doing so serve a leading role in public sector biomedical technology transfer policy and practice Division of Policy: The U.S. Department of Health & Human Services (HHS) has designated NIH as the lead agency for biomedical technology transfer and intellectual property matters for HHS Develops technology transfer policies Division of Technology Development and Transfer: Evaluates, protects, translates and monitors wide range of intramural NIH and FDA technologies

4 NIH Office of Technology Transfer Director Director, Division of Technology Development and Transfer Deputy Director, Licensing and Entrepreneurship Deputy Director Director, Division of Policy Royalty Administration Unit Program Staff Marketing Group Policy Specialists CRADA Staff Cancer Branch General Medicine Branch Infectious Diseases and Medical Devices Branch Service Center Branch Monitoring and Enforcement Branch Senior DTDT Staff Program Specialist NIH/FDA Intramural Research Pipeline Novel, fundamental discoveries early stage therapeutics and diagnostics Selected technologies in early preclinical/early clinical studies Research Tools Broad spectrum of technologies that are representative of the various ICs of NIH/FDA

5 Technology Transfer at NIH ICs: Coordinate development of technologies and negotiate Cooperative Research and Development Agreement Clinical Trials Agreement Material Transfer Agreement OTT: Evaluates technologies, manages patent prosecution through contract law firms, markets technologies and negotiates license agreements with companies and institutions Exclusive Patent License Non-Exclusive Patent License Non-Exclusive Patent License for Internal Use Commercial Evaluation License Biological Materials License Biological Materials License for Internal Use Inter-Institutional Agreement (IIA) NIH OTT s Ownership, Incentive and Royalty Sharing Practices Intramural scientists obligated to disclose inventions through Employee Invention Reports Assign IP rights to the U.S. Government OTT typically executes IIAs for co-owned inventions with a split for costs and royalties Royalties support further research Inventors included in providing technical input Inventors receive: First $2K 15% of royalties between $2K and $50K 25% of royalties in excess of first $50K received each year Cannot receive more than $150K in royalty payments per calendar year

6 NIH Patenting Policy for Intramural Inventions Further R&D necessary to realize technology s primary use Facilitates availability of the technology for preventative, diagnostic, therapeutic or other commercial use Public health value of technology warrants expenditure of funds Ongoing research expected to support practical utility or a reasonable expectation of future practical utility Share Knowledge While Protecting IP Aim to improve public health Technology Evaluation Considerations: Seek patent protection License without patent protection Dedicate to public domain Waive rights to inventor Typical Patent Filing Strategy: File a U.S. provisional patent application Followed by a PCT Followed by National Stage filings as appropriate Commercialize early stage technologies

7 NIH Licensing Principles for Intramural Inventions Maximize development of products to benefit public health and obtain appropriate return on public investment Grant only the appropriate scope of rights Prefer non or partial exclusivity Specify field of use Ensure broad use Reserve research uses on a nonexclusive basis Ensure publication rights Include enforceable benchmarks and milestones Monitor annual progress reports NIH Technology Transfer Goals Benefit the public health Utilize IP rights appropriately as incentives for commercial development Patents and licenses are currency of commercial technology transfer Patent protection appears fundamental for drugs Obtain return on public investment Attract new R&D resources Stimulate economic development

8 Thank You! NIH Office of Technology Transfer Science. Ideas. Breakthroughs.