DOE Integrated Support Center: Intellectual Property Law Division Update

1. Integrated Support Center (ISC-CH)Intellectual Property Law Division (IPL) Michael J. Dobbs Deputy Chief Counsel for Intellectual Property ISC-CH -- U.S. Dept. of Energy Mike.Dobbs@science.doe.gov Tel: (630) 252-2164 September 10, 2019 Providing responsive and impactful legal counsel to our customers and ensuring effective management and protection of DOE funded Intellectual Property.

2. Agenda • Recent Utilization Reporting Minor Upgrades • Pending Utilization Reporting Minor Upgrades • iEdisonBackground • iEdisonRewrite

3. Utilization Reporting Minor Upgrades (July 19, 2019) • Requires all DOE funded awardees to submit annual utilization reports (2 CFR 910.364) • Reports are due at the end of the awardee’s fiscal year (configurable by Awardee in iEdison). • DOE Labs have been advised to ignore utilization messages. • Added 6 questions to the existing 9 iEdison utilization questions. • Approximate number of new US-based jobs created because of commercialization efforts during the reporting period • Number of new US-based companies created from the commercialization efforts during the reporting period. • List unique commercial products made through the use of or embodying the subject invention. For each product, also list the associated NAICS code (if applicable) • The manufacturing location(s) of each commercial product listed. • Total number of each commercial product made at each location. • Describe how the development and commercialization of the subject invention comply with any required U.S. manufacturing requirements (e.g., U.S. Preference, a U.S. Competitive Clause, U.S. Manufacturing Plan, etc. .)

4. Pending Utilization Reporting Minor Upgrades • Add a link to DOE’s Utilization report guidance at https://www.energy.gov/eere/funding/invention-utilization-reports • Hide the FDA question when DOE is the only funding agency.  This question is not applicable to DOE funded work and may be confusingly similar to our commercialization question. • Add another text field for “Additional Information Requested by Program”. • Update the batch upload tool to accept DOE’s utilization questions. • Update the agency export tool to export DOE’s utilization questions. • Reporting tool in iEdison includes all fields

5. iEdison Background • iEdison – Interagency Invention management system currently managed by NIH. Shared docketing system for reporting compliance. • Bayh-Dole Act 35 USC 201 et seq.: Grants a Non-profit or small business firm the right to elect title to their subject inventions. Previously the Government took title (e.g. AEA, NNEA). • Other entity types (e.g. Large Businesses, Foreign) granted through Executive Order 12591 (1987) unless otherwise prohibited by statute (e.g AEA, NNEA). DOE has several patent waiver to waive title to large businesses (e.g. EERE, FE and ARPA-E) • Declaration of Exceptional Circumstance (DEC) • Bayh-Dole 1.0 – Commerce Bayh-Dole Regulations (60 FR 41812, Aug. 14, 1995) • Limits the initial patent application to just a non-provisional patent application • Provides a limited 60 day window from “learning of the failure” for an agency to demand title. • Bayh-Dole 2.0 – Commerce Bayh-Dole Regulations (83 FR 15954, Apr. 13, 2018) • Not yet well utilized (currently in GNP-119 and upcoming DEAR rewrite) • Broadens the initial patent application definition to provisional, non-provisional and PCT patent applications. • Removes the limited 60 day window from “learning of the failure” for an agency to demand title. • Establishes a new (extendable) timeline for filing a non-provisional application within 1 year of a provisional.

6. iEdison Pending Upgrades (DOE Request Submitted 2/14/2018) • In compliance with Bayh-Dole 2.0 (Effective May 2018) • Ability to handle different award terms • Bayh-Dole 1.0 • Bayh-Dole 2.0 • DEC/NNEA/AEA • New timelines • 1 year to file a non-provisional application after an provisional application • Security Updates • Streamlined account creation • Utilization Reporting Updates • Add functionality for agencies to add additional agency specific questions • Enhanced Search, Display, and Export Functionality • Invention Record Validation before assigning iEdison Number • Agency and awardee system-to-system connectivity • USPTO Confirmatory License Automated Submission to USPTO filing • Routing functionality for agency approvals

7. iEdison Upgrade Overview • Initial effort for NIH to manage rewrite was unsuccessful. • NIST plans to rewrite, manage and maintain iEdsion using ~$4M for iEdison rewrite. (FY18 and 19 funds) • Delays due to NIST legislative technology transfer legislative reforms. • NIST engaging with a small, inter-agency group to develop requirements. Expect requirements to be released for public comment. • All data will be transferred. NIH will continue to maintain iEdison during product development. • Expected that NIST will release an “Agency Feedback Questionnaire”. • RFI and RFP is expected to be competitive and open to respondents including custom software developers and docketing system venders • Goal of deployment before end of FY20. (May be difficult.)

8. iEdison Upgrade Impact to DOE Labs and Awardees • Limited enhancements until rewrite (eta FY20) • New user interface. Training is anticipated. • Expected that existing system-to-system data transfer will continue to be supported. However, custom development and vender development may be needed to access new fields and functionality.

9. Questions? ?

10. Invention Reporting Timeline Bayh-Dole 1.0 (iEdison 1.0) Initial PCT/Provisional Patent Application Filing & Reporting Initial Non-Provisional Patent Application Filing & Reporting Confirmatory License Submission (anytime after filing) Patent Issuance Reporting Invention Report Invention Disclosure Election Decision Less than 1 year Less than 2 mo. Less than 2 years • *DOE may extend any due dates (including invention reporting) • with substantive justification. • **If the awardee will not continue patent efforts, most notify agency not less than 30 days prior to expiration of statutory deadline

11. Invention Reporting Timeline DOE Bayh-Dole (Bayh-Dole 2.0) Initial Provisional Patent Application Filing & Reporting Confirmatory License Submission (anytime after filing) Patent Issuance Reporting Initial Non-Provisional Filing Invention Report Invention Disclosure Election Decision Less than 1 year Less than 2 mo. 10 mo. Less than 2 years • *DOE may extend any due dates (including invention reporting) • with substantive justification.