- Q: What
is the Federal mandate that requires an extramural invention tracking
system?
A: New provisions to the
Code of Federal Regulations came with the enactment of the Bayh-Dole
Act of 1980. These provisions (CFR) stipulated the need for
all grantees or contractors to report on activities involving
the disposition of certain intellectual property rights that
result from Federally funded research (37CFR Part 401). With
the growing emphasis that is being placed on technology transfer;
it is now common for universities and research organizations
to have offices devoted to transfer of research results to the
commercial sector, in addition to fulfilling government-reporting
requirements contained in 37CFR Part 401.14. The reporting requirements
contained in the federal regulations, suggest the value of a
system that ensures timely communication at all points along
a time frame that can last 20 years from filing a patent application
to the expiration of a corresponding patent. Any system designed
to track the reporting of such inventions should be designed
consistent with reporting requirements defined under law, promulgated
in the form of regulations by the Department of Commerce, and
implemented by Federal agencies. A second objective realized
by such a system is the effective dissemination of relevant
information from agencies to their grantee or contractor organizations
regarding recently enacted or proposed legislation and policy
that may impinge on the grantee or contractor organization's
invention development activities. Interagency Edison has been
designed, developed, and implemented to enable grantee and contractor
organizations to directly input their invention data as well
as update information in real time on a fully interactive basis.
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- Q: How
has this tracking been done until now?
A: Since before the inception
of the Bayh-Dole Act of 1980, until iEdison was deployed in
1995, information had been sent to cognizant federal agencies
via hard copy. Staff at the various agencies were responsible
for maintained paper-based systems for tracking. Edison was
first deployed in 1995 for the benefit of the NIH, and, in 1997,
with the addition of the NSF and USAID, came the introduction
of Interagency Edison (iEdison). Through the iEdison single
user interface, inventions supported by any of these three agencies
could be reported electronically. The data is partitioned within
the single iEdison database so that each agency can oversee
their invention reports. Since 1997, iEdison has grown to where
now approximately 500 grantee or contractor organizations are
registered and using the system, and inventions supported by
any of 18 federal agencies can be reported through the iEdison
system.
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- Q: What
are the general features of the electronic tracking system?
A: To attain both goals
as set forth above, iEdison has been designed, to receive, store,
track, sort and generate reports of information submitted by
grantee and contractor organizations regarding inventions and
patents that have resulted from extramural grant and/or contract
funding. This system has now been re-written in a new technology
that provides additional functionality to its users.
The iEdison system allows:
- Both agency staff, grantee and contractor organizations
to access real-time invention/patent information.
- Only authorized users to gain access to records for their
grantee or contractor organizations.
- Users to add/modify existing data and query the database
to generate reports.
- Users to view a graphical representation of an invention
and its related patents.
- Users to upload all aspects of the invention and patent
reports electronically: no paper submissions are required.
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- Q: Is
use of the Interagency Edison system mandatory for all grantee
and contractor organizations?
A: Grantee and contractor
organizations are formally obligated only to meet the mandated
reporting requirements stated in 37CFR Part 401.14. When the
legislation was enacted, electronic transmission of information
was not considered. In 1995, the Department of Commerce announced
an interim rule in the Federal Register (Vol. 60 No. 156) allowing
for the electronic submission of subject inventions to agencies.
The use of Interagency Edison, however, is not mandatory for
inventions and patents developed under federal funding agreements.
The popularity of iEdison reflects a new era in research administration.
It is in this spirit that Interagency Edison includes features
that streamline administrational tasks for both federal and
grantee and contractor organization staffs. The time and resources
involved in preparing hard copy documents for submission is
obviated by employment of Interagency Edison. The ability to
rely on such a system for timely reminders of reporting, as
well as to plan and generate reports that can be used by the
grantee or contractor organization for in house administrational
activities, further warrants consideration of Interagency Edison.
While additional effort on the part of the grantee or contractor
organizations are necessary to become conversant with this electronic
medium, the success of iEdison supports the positive returns
realized.
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- Q:
What are the system requirements and any additional costs involved
in using Interagency Edison?
A: Access to Interagency
Edison by the grantee or contractor organization requires only
a browser connected to the Internet. The interface can reside
on either Microsoft Windows(R)-capable personal computer or
a Macintosh(R). Security measures included in the Interagency
Edison system provide for full encryption of the grantee and
contractor organization's information as it is being transmitted
across the Internet.
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- Q:
How is relevant information entered into the database by each
grantee and contractor organization?
A: Data is entered into
this database via three input forms. Once connected to the system,
a user accesses a login area that permits, with proper username
and password, access to all records from their grantee or contractor
organization. Options on such a screen permit addition of new
information or modification of existing information on one or
more form screens. Each form contains information relating to
one of three different groups of data. These groups are:
- Information relating to inventions disclosed by the grantee
or contractor organization to its reporting agency,
- Patent data, and
- Invention utilization data.
In addition, the following functionality is provided:
- A graphical presentation of the relationship between inventions
and patents
- Several query screens to help quickly locate the information
to be reviewed/modified
- Ability to upload binary documents (PDF or TIFF images)
that describe the invention (the so-called invention disclosure),
the confirmatory license, and the government support clause
portion of the patent. Once uploaded, the user can view documents
submitted along with invention report and patent records
- Verification screens that provide the user with the opportunity
to review data prior to submission to the database, as well
as present formal reminders of obligations of the grantee
and contractor organizations under the law with regard to
the reporting of inventions, patents and invention utilization.
- A message notification screen is also resident in the system
to remind federal staff and the grantee and contractor organization
of upcoming deadlines for a particular invention report that
follow from the provisions of 37CFR Part 401.14.
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- Q:
How is information kept confidential? What security features have
been incorporated into the tracking system?
A: Security and confidentiality
of the invention reports are seen as paramount in the value
of iEdison. Accordingly, a multi-tiered security system has
been incorporated that provides for a number of different levels
of security at each stage of data input. Each grantee and contractor
organization is able to access their records only after completion
of an authentication process requiring username and password.
All users (federal and extramural grantee or contractors)
are required to log onto Interagency Edison. When a grantee
or contractor organization attempts to access Interagency Edison,
the identifiers are compared to the values in an authorization
table that resides within the database server. Access is denied
unless all values are correct. Information transmitted on the
Internet is encrypted.
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- Q:
What data entry options are available for grantee and contractor
organizations that already have invention, patent, and licensing
data on an electronic database?
A: Exclusive of the Internet-based
browser access, a secondary mode of access is also available
to serve grantee and contractor organizations with database
systems in place. Without this capacity, such institutions would
be faced with re-keying data. iEdison includes software that
enables grantee and contractor organizations to send information
to the Interagency Edison system via bulk, computer-to-computer
transmission One part of the iEdison site provides information
for grantee and contractor organizations who wish to consider
this type of transaction, see: "Special Instructions for
Organizations that have Large Databases."
Also several third party vendors who market intellectual property
software now offer a feature that allows for the automatic submission
to iEdison of records created in their software package.
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- Q:
How does the information that is included in the iEdison report
compare with what grantee and contractor organizations report
via hard copy?
A: In defining the type
and extent of information requested from grantee and contractor
organizations, several sources were considered, including: findings
and recommendations from the Office of Inspector General Reports,
comments received from the extramural grantee and contractor
community, as well as suggestions and comments from representatives
of the Association of University Technology Managers (AUTM)
and the Council on Government Relations (COGR). The majority
of data fields in iEdison are deriving directly from specific
provisions of 37CFR Part 401.14. Some fields have been added
for several reasons. Time sensitive data fields are included
to activate a message notification system that alerts both federal
agency staff and the grantee and contractor organizations of
impending deadlines inherent in 37CFR Part 401.14. In light
of recent Congressional inquiries as to utilization of patented
products, the data fields that address utilization have also
been expanded.
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- Q:
Is data entry into all the fields required?
A: To preserve the relational
aspects of the Interagency Edison database, entry of data into
certain fields is absolutely required. This is the case since
such fields provide for the system's unique identifiers (e.g.,
the Extramural Invention Report (EIR) Number and Invention Docket
Number) necessary to maintain integrity of the overall hierarchical
structure of a grantee and contractor organization's file. Moreover,
input of such information also serves to provide information
necessary to trigger the message notification portion of iEdison.
Notices are displayed on the screen and/or sent to the grantee
and contractor via e-mail to alert of the timely need to submit
various items. Without the proper information, e.g. invention
report date, or title election date, the notifications will
not have any relevant reference time point.
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- Q:
What help features have been included in the system to anticipate
questions that come up during an on-line session?
A: Associated with every
data entry screen is a help screen that can be activated on
an optional basis. The help screen describes the data fields
on the screen (providing a brief explanation as to relevant
issues and summarizing the format of data that is required),
provides general help instructions for the selected screen,
and lists related help topics for the screen in question. In
addition, prior to the completion of the on-line session, a
confirmation screen is encountered to offer the user the opportunity
to review data entries, either on the screen or via a print
out. Inherent in this confirmation activity is the review of
the most pertinent time sensitive data requirements along with
the provisions of 37CFR Part 401.14 that mandate such information.
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- Q:
Are additional training manuals or outreach efforts planned?
A: iEdison outreach is
ongoing. Presentations are routinely given at national meetings,
with particular emphasis at tools meetings of the Association
of University Technology (AUTM). With the new version of iEdison
will likely come a user manual.
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- Q:
How extensive is the use of iEdison?
A: Pilot testing of the
original Edison was completed in spring of 1995. Almost from
its initial introduction, the number of grantee and contractor
organizations have increased. Today in excess of 500 organizations
are registered to report inventions through iEdison. Estimates
suggest that this number of organizations represents better
than 90% of the organizations that routinely submit Bayh-Dole
invention reports. Organizations interested in using Interagency
Edison/Edison for invention reporting should review the "Help"
section devoted to organization registration that appears on
the top of the iEdison home page.
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- Q:
How has the iEdison system been made available to other Federal
research agencies?
A: The iEdison system includes
adequate access authorization to limited sets of data, for different
agencies. Toward this end, a government-wide network has been
put in place via the iEdison system, which controls authorized
access, by any research agency of Edison information that pertains
to that agency. Therefore, the data fields in iEdison recognize
inventions funded by other agencies and participating in iEdison.
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- Q:
What is a DUNS number?
A: Provided by Dun & Bradstreet,
the DUNS number is a nine-digit number that uniquely identifies
a business entity.
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- Q:
How can grantee and contractor organizations get additional information
about the iEdison system?
A: Any grantee or contractor
organization that is interested in the system, would like to
have additional information, or has any questions regarding
Interagency Edison, should feel free to contact:
iEdison
Division of Extramural Inventions & Technology Resources (DEITR), OPERA, OER
National Institutes of Health (NIH)
6705 Rockledge Drive, Suite 310, MSC 7980
Bethesda, MD 20892-7980
Phone: 301-435-1986
Fax: 301-480-0272
e-mail: Edison@nih.gov