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Extramural Intellectual PropertyExtramural Intellectual Property

1111thth Annual NIH SBIR/STTR Conference Annual NIH SBIR/STTR ConferenceJune 30, 2009 – Omaha, NebraskaJune 30, 2009 – Omaha, Nebraska

Protecting Your Intellectual Property Protecting Your Intellectual Property under your SBIR/STTR through iEdison under your SBIR/STTR through iEdison

Invention:Invention:Why, When, & How - iEdisonWhy, When, & How - iEdisonJ.P. Kim, J.D., M.B.A., M.Sc., M.A.L.S.,J.P. Kim, J.D., M.B.A., M.Sc., M.A.L.S.,

Directory & Policy Officer,Directory & Policy Officer,Division of Extramural Inventions & Technology Resources Division of Extramural Inventions & Technology Resources (DEITR), OPERA, NIH Office of Extramural Research (OER), (DEITR), OPERA, NIH Office of Extramural Research (OER), OD,OD,National Institutes of Health (NIH),National Institutes of Health (NIH),U.S. Department of Health & Human Services (HHS)U.S. Department of Health & Human Services (HHS)Email: Email: jpkim@nih.gov

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WhyWhy report inventions? report inventions?

The Bayh-Dole Act 35 U.S.C. 200 et al.

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What Are the Main Provisions of the What Are the Main Provisions of the Bayh-Dole Act (1980)?Bayh-Dole Act (1980)?

Provides title of Federally supported inventions to vest with the grantee/contractor organization

Requires all grantee/contractors to demonstrate progress toward transfer of the technology

Requires acknowledgment of the government’s involvement and license

Government use license Federal support clause in the patent

Provides incentive to inventors and more rapid development and commercialization

Applicable to ALL U.S. Government-funded grantees and contractors: Domestic and Foreign

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What is an Invention What is an Invention (per Bayh-Dole)?(per Bayh-Dole)?

37 CFR Section 401. 14 Standard patent rights clauses.

(a) Definitions (1) Invention means any invention or discovery

which is or may be patentable or otherwise protectable under Title 35 of the United States Code, …

(2) Subject invention means any invention of the contractor conceived or first actually reduced to practice in the performance of work under this grant or contract,…

Does not include solely copyrightable materials, e.g., books

Includes software; deemed patentable as of late ’90s

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Noted MisconceptionsNoted Misconceptions

The government owns my invention.

If I report an invention, NIH (the government) will take my invention. No,

By not reporting my invention to NIH, I will secure rights to an invention.

No, rights vest with the SBIR/STTR organizationNo, rights vest with the SBIR/STTR organization

NIH is not in competition with recipients.NIH is not in competition with recipients.

No, there is a greater risk of loss of rights by not No, there is a greater risk of loss of rights by not reporting.reporting.

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Stewardship of Federal FundsStewardship of Federal Funds

How funds will be expended Fiscal management Programmatic assessment

How research will be conducted Research integrity Conflict of interests

How research outcomes will benefit the public Share outcomes to spawn new research ideas Encourage application of intellectual property

Practical Applications are an Important Part of Stewardship

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1994 Congressional Inquiry 1995 Follow up compliance study 1997 GAO Audit

Bayh-Dole Administration 1998 GAO Audits

E.O. 12591 Confirmatory licenses/Gov’t support clauses

1999 IG and GAO Audits SBIRsSBIRs Grantee compliance 5 year follow up to 1994 Report

2000 – 2001 OIG: Further Revision of 1994 Report 2002 GAO - Use of Confirmatory Licenses 2003 GAO – Government Involvement in Taxol IP 2005 Congressional Inquiry

The Importance of Invention The Importance of Invention Reporting:Reporting:Constant Scrutiny of NIH and Constant Scrutiny of NIH and GranteesGrantees

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WhenWhen do your report inventions? do your report inventions?

The Bayh-Dole Act and its Implementing Regulations https://s-edison.info.nih.gov/iEdison/37CFR401.

jsp Extramural Invention Reporting

Compliance Responsibilities https://s-edison.info.nih.gov/iEdison/timeline.js

p

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Implement Employee Agreements as needed Disclose Each Invention within 60 days Resolve Election or Waive of Title within 2 years File Patent within 1 yr. of election Provide License to the Govt. upon title election Indicate Govt. Support on Patent with patent

appl. Product Manufacturing in U.S. required Report on Invention Utilization annually Final Invention Report at award close out

Invention Reporting Invention Reporting Requirements Requirements of SBIR Grantee/Contractorsof SBIR Grantee/Contractors

Administrative Requirements (per 37CFR, Administrative Requirements (per 37CFR,

401.14)401.14)

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Annual Invention Utilization Annual Invention Utilization Reporting is Required for NIHReporting is Required for NIH

NIH Grants Policy Statement, 12/03 Revision, Page 119:

“Grantees (and, in some cases, employee inventors) have rights to inventions (“subject inventions”) conceived or first actually reduced to practice in the performance of work under an NIH award. Grantee organizations must fulfill the following requirements: Submit an annual utilization report for all

inventions where election of title is made and for unpatented, yet licensed, inventions (37 CFR 401.14(h));…”

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Utilization Report Utilization Report RequirementsRequirementshttps://s-edison.info.nih.gov/iEdison/utilization_reporting.jshttps://s-edison.info.nih.gov/iEdison/utilization_reporting.jspp

Report according to grantee/contractor-defined 12-month reporting cycle

1. Please indicate the latest stage of development of any product arising from this invention according to the following categories: Not Licensed/Licensed/Commercialized

2. In the designated reporting period, what was the total income received as a result of license or option agreements? Do not include specific patent costs reimbursement.

3. If any product arising from this invention has reached the market, what was the calendar year of the first commercial sale?

4. In the designated reporting period, did the grantee organization/contractor or any of the exclusive licensees request a waiver of the U.S. manufacturing requirements? If yes, how many such waivers were obtained?

5. In the designated reporting period, how many licenses and/or options of any type were awarded to small businesses (< 500 employees)?

6. In the designated reporting period, how many exclusive licenses and/or options have been awarded?

7. In the designated reporting period, how many non-exclusive licenses and/or options have been awarded?

8. Please provide the commercial name of any FDA-approved products, utilizing this invention, that have first reached the market during the designated reporting period.

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If title elected, patent may be filed

Evaluation is made as to whether it may be patentable (if yes, University A reports discovery to NIH thru iEdison)

Discovery is Reported to University A’s technology transfer office

A Discovery is made under Grant X Funding by the PI and/or other(s)

PI at University A Receives NIH Funding under Grant X

Discovery is brought to practical application thru dissemination, publication, or further development into a final product to benefit public

Evaluation is made by University A as to whether it may be marketable and licensable

University A makes decision on election of title

University A provides annual utilization reports with FDA approved product names to NIH

The Technology Transfer ProcessThe Technology Transfer Process

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HowHow do you report inventions? do you report inventions?

iEdison (http:/iEdison.gov)

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Secure, Interactive Web-Based System for Bayh-Dole Policy and Reporting Compliance

Didactic Content to inform investigators & grantee/contractor organizations

37CFR 401 Invention Policy Issues Invention Reporting Procedures/forms

Current submission of Invention Report Records to any of 25 participating Federal Agencies including:

NSF NAVY/ONR USDA/CSREES HHS/FDA USAF/AFOSR USDA/Forest Service HHS/CDC DOC/NOAA USDA/ARS USAID EPA USAF/ESC HHS/ATSDR HHS/IHS

HHS/AHRQ (AHCPR) Army/SSC

Army/MRMC NIH

AFRL/IF Army/SMDC DOD/DMEA

http://iedison.gov

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Submission via browser or computer-to-computer datastream

Used by ~1300 grantee/contractor organizations

iEdison Tutorial http://era.nih.gov/ProjectMgmt/iedison2/index.cfm

iEdison Registration https://s-edison.info.nih.gov/iEdison/RegistrationR

equestForm.jsp

Help Line: (301) 435-1986 Email: Edison@od.nih.gov

http://iedison.gov

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Why Use iEdison?Why Use iEdison?

Secure, relational, real time database with all invention reporting business rules built in

Offers reminders of time critical reporting obligations iEdison supports full electronic reporting: no paper is

needed if you have the information electronically Requires minimal hardware/software

Internet connection Browser

Meets invention reporting requirements for diverse population of interagency grantees/contractors

Provides single gateway for invention reporting for over 25 government agencies

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NIH Extramural Intellectual NIH Extramural Intellectual Property Resources for Property Resources for SBIR/STTR AwardeesSBIR/STTR Awardees

Interagency Edison http://iEdison.gov

Extramural Inventions

J.P. Kim, (jpkim@nih.gov),Director & Policy Officer,Division of Extramural Inventions & Technology Resources, OPERA, NIH Office of Extramural Research, OD, NIH, HHS

John Salzman, (js99a@nih.gov),Assistant Extramural Inventions Policy Officer,

Division of Extramural Inventions & Technology Resources, OPERA, NIH Office of Extramural Research, OD, NIH, HHS

(301) 435-1986

iEdison User Support edison@od.nih.gov (301) 435-1986

Websites: http://iEdison.gov http://inventions.nih.gov