# Presentation: 341635

## Second Annual NIH SBIR/STTR Conference:Research to Health Benefits through Commercialization  SBIR-Derived Inventions: Protection of Intellectual Property Rights While Creating Incentives for Technology Transfer

- George Stone, Ph.D. and Linda Stecklein
- Office of Grants Policy
- NIH

## What is Intellectual Property?

- Intangible --
- Idea, concept, discovery
- Distant from the revenue stream
- Manifested as Tangible
- Inventions/Patents
- process, software, equipment, research tools, biological materials, licenses
- Copyrights -- written document
- Trademarks
- Closer to the revenue stream

## What is an Invention?

- Intellectual property which is or may be patentable or otherwise protectable under Title 35 of the United States Code...
- An invention is anything made by the "hand of man," that is a new, useful, and unobvious process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.

## Government Supported Inventions

- Defined as “Subject Invention”
- Per 37 CFR 401.2 (d)
-    “Any invention of a contractor (grantee) conceived or first actually reduced to practice in the performance of work under a funding agreement.”
- Question of ownership
- Tax Payers’ Dollars
- Economic Fuel

## ...it was the Government’s...
(if we wanted it)

- (if we wanted it)

- ...in the beginning...

## Government-Supported Intellectual Property...pre-1980

- Any intellectual property derived through Federal funding agreements could be claimed by the Government
- F.A.R. 52.227-13
- Not uniformly exercised across the Government
- Result = no commercialization incentive

## (compliments of Birch Bayh and Bob Dole) ... it became the Grantees’ or Contractors’...(with a few conditions)

- ...and then...

## Bayh-Dole Act Of 1980

- Gave Grantee Organizations/Contractors title to inventions arising from federal funding agreements
- Government retains license to practice the invention
- Prescribes what actions the Government may take to protect/retain rights
- Result = Commercialization of Federally funded inventions

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

- Provides title of Federally supported inventions vests with the grantee/contractor organization
- Requires the grantee/contractor to demonstrate progress toward transfer of the technology
- Requires acknowledgment of the government’s involvement and license
-  Federal support clause in the patent
-  Government use license
- Provides incentive to inventors and more rapid development and commercialization

## What Are the Responsibilities of an SBIR/STTR Recipient?   

- Report invention to NIH - within 60 days
- Election of Title -- within 2 years of disclosure
- File Patent Application -- within 1 year after election of title
- Utilization Report -- annual, as of election of title
- Final Invention Report -- close out documentation -- 90 days after project ends

## Are There Other Responsibilities?

- Implement employee agreement system
- Provide nonexclusive (confirmatory) license to the Federal government
- Indicate NIH support on patent application and on issued patent(s)
- Preference for domestic manufacturer, small businesses
- Notify NIH/IEdison of any decision not to pursue rights

## Are Any of These Requirements Unique to SBIR/STTR?

- Invention reporting is uniform for all NIH grantees/contractors
- All Federal agencies are subject to the Bayh-Dole as are all grantees/contractors
- NIH does not have any additional business rules regarding invention reporting requirements or policies

## Noted 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 organization***
***NIH is not in competition with recipients.***
***No, there is a greater risk of loss of rights by not reporting.*****                                                                                                                       **

## What is the Best Approach to Protecting Inventions Supported by NIH?

- Make arrangements up front with all parties to determine/insure rights to inventions.  (included  as part of the STTR application process)
- Comply with all government-wide reporting requirements  (37 CFR 401.14)
- Use IEdison as it electronically provides the support of a fully staffed and trained technology transfer office

## What is Interagency Edison?

- An electronic database designed by NIH to provide all grantees and contractors with a system to manage their intellectual property portfolios per Bayh-Dole (37 CRF 401)
- Designed to improve compliance with government-wide invention reporting requirements
- Use of IEdison insures that decisions regarding the commercial value of an invention are made within established time frames

**Notes:**
Jump right into this, as this group knows what commercialization is.  This will seem like a sales pitch cuz it is.  A great opportunity to promote the understanding and use of Edison.

## Reporting Requirements in 

**PATENT**

**PATENT**

**PATENT**

**LICENSE**

**LICENSE**

**LICENSE**

**LICENSE**

**LICENSE**

**LICENSE**

**LICENSE**

**LICENSE**

_** **__**Time **_
_**Frame**_

- 20+years

_**Time Critical**_
**   **_**Events**_

***Elect Title***

***File Patent***

***Product***
***  ******Dev.***

***Licensure***

***Sales***

- Reporting Requirements in
- The Invention/Patent/Licensing Process

_**  **__**Reporting**_
_**Requirements**_

***Disclosure***

***Title ***
***Disposition***

***Patent Face***
*** ******Page***

***Confirmatory***
***License***

***Utilization***
***Report***

## Submission of Invention Report Records via Secure, Interactive Web-Based System 
 Production Deployment - Oct. ‘95
   via browser - information keyed in
   via ‘Internet Talkers’ - computer-to-computer
Edison url =  http://edison.nih.gov

- Submission of Invention Report Records via Secure, Interactive Web-Based System
-  Production Deployment - Oct. ‘95
-    via browser - information keyed in
-    via ‘Internet Talkers’ - computer-to-computer
- Edison url =  http://edison.nih.gov

## 1997:Edison expanded for Interagency Use
equivalent technology to Edison
Currently ~230 grantee/contractor  			   organizations using Interagency Edison
url = http://www.iedison.gov
Participating IEdison Agencies

- 1997:Edison expanded for Interagency Use
- equivalent technology to Edison
- Currently ~230 grantee/contractor  			   organizations using Interagency Edison
- url = http://www.iedison.gov
- Participating IEdison Agencies

- NSF
- FDA
- USDA/CSREES
- USAID
- Army/MRMC
- AFOSR

- CDC
- NOAA
- AHRQ
- ATSDR
- EPA

## Slide 19

## Slide 20

## Slide 21

## Successful Deployment of Edison/Interagency Edison

- Months since Edison Deployment (Oct 95 – Jan 00)

## Why Use IEdison?

- It is a secure, relational, real time database with all invention reporting business rules built in
- Requires minimal hardware/software
- Internet connection
- Browser
- Acknowledged by most of the major grantees and contractors at NIH as a sophisticated, powerful way to fulfill invention reporting requirements

## Why Use IEdison?

- IEdison meets the invention reporting requirements for diverse population of grantees/contractors
- Provides single gateway to meet invention reporting requirements for 12 government agencies

## NIH Resources for SBIR/STTR Grantees/Contractors

- Interagency Edison   www.iedison.gov
- a secure, relational Web site for reporting inventions  (e-mail user support :  edison@od.nih.gov; 301-435-1986
- George Stone:  Branch Chief
- 	george.stone@nih.gov
- Linda Stecklein:   Policy Analyst
- 	ls41g@nih.gov
- John Salzman:  User Support
- 	edison@od.nih.gov