Notice Number: NOT-OD-15-119

Key Dates
Release Date: July 2, 2015

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this Guide Notice is to inform recipients of NIH Extramural Research Funding Agreements about updates to the iEdison system regarding Bayh-Dole reporting requirements and compliance messages.

Previously, users could change the status of a subject invention or patent to a Not Elect Title - Waive status in iEdison with unresolved compliance issues. This change of status did not delete or remove previously required Bayh-Dole compliance steps or notices to NIH. The change of status designation simply indicates a recipient's request to the Government to waive title to the subject invention. Title waivers are not effectuated while compliance issues remain outstanding. It is important to note that this is NOT a policy change.

This ability to change a status in iEdison while compliance issues remain unresolved caused confusion among our funding recipients about the status of the subject invention. This update to iEdison is intended to alleviate this confusion and to assist the user by ensuring that inventions and patents are not mistakenly understood to be waived prior to the resolution of outstanding notification messages.

Background

The Bayh-Dole Act of 1980

Application to Federal Funding Recipients

The Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C. 200-212) and the related Executive Orders 12591 (April 10, 1987) and 12618 (December 22, 1987) provide incentives for the practical application of research supported through Federal funding agreements. To be able to retain rights and title to inventions made with Federal funds ( subject inventions ), the funding recipient must comply with a series of regulations that ensure the timely transfer or licensing of the technology to the private sector, while protecting the rights of the Federal government.

The regulations apply to any subject invention defined as any invention either conceived or first actually reduced to practice in the performance of work under the Federal award and to all types of recipients of Federal funding. This includes non-profit entities and small businesses or large businesses receiving funding through grants, cooperative agreements, or contracts as direct recipients of funds, or as consortium participants or subcontractors under those awards.

iEDISON Updates

Users Cannot Waive Subject Inventions and Patents Unless Bayh-Dole Required Compliance Actions are Taken and the iEdison Notification Messages are Resolved

Until all outstanding compliance issues and notification messages are resolved, iEdison will no longer permit a user to waive title to an invention or patent. The following is a non-exhaustive list of examples of actions that need to be taken and Compliance Notification Messages that an iEdison user may encounter:

• No written description of this invention (Disclosure) has been uploaded into iEdison;
• A Government Support Clause is missing (or not accepted) for a non-provisional patent filing;
• The submitted Confirmatory License is missing (or not accepted) for a non-provisional patent filing;

Also, iEdison Users Cannot Waive an Invention until All Patents Linked to that Invention Have Been Previously Waived and All Reporting Requirements are Satisfied

iEdison users will no longer be permitted to waive an invention if any related patent(s) has not previously been waived by the user and all reporting requirements satisfied .

Inquiries

Please direct all inquiries to:

Scott Cooper
Division of Extramural Inventions & Technology Resources (DEITR)
Office of Policy for Extramural Research Administration (OPERA)
Telephone: 301-435-0785
Email: Scott.Cooper@nih.gov