Federal Laboratory Consortium and Technology Transfer at the NIH - PowerPoint PPT Presentation

Federal Laboratory Consortium and Technology Transfer at the NIH Mojdeh Bahar, J.D., M.A., CLP Chair, Federal Laboratory Consortium Chief, Cancer Branch Office of Technology Transfer National Institutes of Health U.S. Department of Health & Human Services American Chemical Society Science & the Congress Project July 27, 2012

Presidential Memorandum Calls for Increased Federal Procurement of Faster, Cheaper Strategy for Bio-based Products Federal Tech Transfer America Invents Act Passed Senate Passes Patent by Congress Bill Obama Signs Technology Transfer and Patent Commercialization Landscape of Overhaul Federal Laboratories Legislation

Tech Transfer Is Now Hot Obama Orders Federal Labs to Help Businesses Create New Products President Obama Signs America Invents Act, Overhauling the Patent System to Stimulate The Presidential Economic Growth, & Announces New Steps to Planner: The Help Entrepreneurs Create Jobs America Invents Act MakingSubmission The President’s Office of Science and More Effective Pre Technology Policy (OSTP): Issues for Grant Congress

Road Map • The Year that Passed • What is the Federal Laboratory Consortium? • Some Important Stats on Federal Agencies • TT at NIH, a GOGO Federal Agency • Some useful tools from FLC • Some useful tools at NIH

What is the FLC The FLC:  Formally created by Congress under the Federal Technology Transfer Act (Public Law 99-502)  Composed of tech transfer professionals from the federal laboratories, their respective agencies, and affiliated organizations Membership reflects:  18 federal departments and agencies  Hundreds of federal government R&D laboratories and centers  $ billions annual budget  > 100,000 scientists & engineers Primary Activities:  Education and Training  Sharing Best Practices/Networking  Professional Recognition  Communications and Coordination

Federal Government Statistics • Nine federal agencies have internal research budgets of greater than 500 million dollars • 4422 new inventions reported (FY ’09) • 1494 patents issued (FY ’09) • DoE is #1 for most number of issued patents (FY’09) • HHS is #1 for the greatest licensing income (FY ’09)

NIH Mission To seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability.

NIH Organization U.S. Department of Health and Human Services Kathleen Sebelius, Secretary National Institutes of Health Francis S. Collins, M.D, Ph.D., Director Office of the Director 27 Institutes and Centers Office of Intramural Research Office of Technology Transfer Science. Ideas. Breakthroughs. NIH Office of Technology Transfer

OTT Mission The mission of OTT is to improve public health through the management of National Institutes of Health (NIH) and Food and Drug Administration (FDA) inventions and in doing so serve a leading role in public sector biomedical technology transfer policy and practice. Science. Ideas. Breakthroughs. NIH Office of Technology Transfer

OTT Goals Benefit the public health Stimulate economic development Obtain return on public investment Attract new R&D resources Utilize IP appropriately as incentive for commercial development of technologies Science. Ideas. Breakthroughs. NIH Office of Technology Transfer

NIH Statistics (FY11) • 3000+ pending and issued US patents • 197 licenses executed • 1,316 active licenses with 759 companies • 351 Invention Disclosures (includes 21 FDA) • 441 licenses reporting products • 25 FDA approved product to date* • 70 products currently in clinical trials • $97M in royalties • Companies report nearly $6B in sales annually for products under OTT licenses

OTT Goals Benefit the public health Stimulate economic development Obtain return on public investment Attract new R&D resources Utilize IP appropriately as incentive for commercial development of technologies Science. Ideas. Breakthroughs. NIH Office of Technology Transfer

Recent TT Initiatives at NIH • eRMA: A website developed to expedite the process for transferring unpatented research materials to for-profit entities, this new system: www.ott.nih.gov/erma • SBIR-TT: Modeled on the NIST initiative • Start-Up License Agreements • Non Profit Model Agreement • Entrepreneur-in-Residence Science. Ideas. Breakthroughs. NIH Office of Technology Transfer

FLC Products and Services: Technology Locator  Technology Locator Network - Centralized service for reviewing and routing requests from potential partners to the appropriate resource - Serves as a point-of-entry to federal laboratory expertise and technology - Responds to requests, monitors and coordinates responses, provides user feedback, and reports on the level of activity

FLC Products & Services: Education & Training • FLC Technology Transfer Desk Reference - Provides a T2 overview and details Cooperative Research and Development Agreements, intellectual property, marketing, legislation, patents and licensing, and more Federal Technology Transfer Legislation and • Policy (“Green Book”) - Details history and legislation associated with federal technology transfer

Sources • Federal Laboratory Technology Transfer, Fiscal Year 2007 and 2009, Summary Report to the President and Congress • Products, Partners & Public Health - "Transfer of Biomedical Technologies from the U.S. Government" Steven M Ferguson, V5 Number 2 (2002) • “The Role of Public-Sector Research in the Discovery of Drugs and Vaccines” Ashley J. Stevens, Jonathan J. Jensen, Katrine Wyller, Patrick C. Kilgore, Sabarni Chatterjee, and Mark L. Rohrbaugh; N Engl J Med. 2011 Feb 10;364:535-541.

Links to Articles • http://www.innovation-america.org/tech-transfer-now-hot • http://www.patentlyo.com/patent/2012/07/pre-grant-submissions.html?cid=6a00d8341c588553ef0176169216df970c • http://thehill.com/blogs/hillicon-valley/technology/190449-obama-orders-federal-labs-to-help-businesses-create- new-products • http://www.fas.org/sgp/crs/misc/RL34736.pdf • http://www.whitehouse.gov/the-press-office/2011/09/16/president-obama-signs-america-invents-act-overhauling- patent-system-stim • http://abcnews.go.com/blogs/politics/2011/09/the-presidential-planner-the-america-invents-act/ • http://www.pcworld.com/article/240153/obama_signs_patent_overhaul_legislation.html • http://www.washingtonpost.com/business/economy/senate-passes-patent-bill/2011/09/08/gIQAvmM8CK_story.html • http://www.natlawreview.com/article/america-invents-act-passed-congress • http://www.physicstoday.org/daily_edition/politics_and_policy/faster_cheaper_strategy_for_federal_tech_transfer • https://www.ida.org/upload/stpi/pdfs/p-4728nsfinal508compliantfedlabttcreport.pdf • http://www.lawbc.com/regulatory-developments/entry/presidential-memorandum-calls-for-increased-federal- procurement-of-biobased/