Bayh-Dole Webinar – Government Support Clauses

Bayh-Dole Webinar – Government Support Clauses

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Good Morning,
My name is Scott Cooper. I work for the Division
of Extramural Inventions and Technology Resources in the Office of Extramural Research
at NIH.
The purpose of this iEdison webinar series is to educate the NIH extramural research community
about the invention reporting requirements of the
Bayh-Dole Act and using the iEdison system to comply with those requirements.
This is one in a series of brief presentations
about Bayh-Dole Act Reporting. I’d like to start off with a brief analogy. This – – –
is Rocket Science.
This … is not Rocket Science. This is the Government Support Clause we will be
discussing today.
So kick back, take off your shoes, put your feet up on your desk, and enjoy the show.
Our agenda and learning objectives today is a
basic introduction to the Government Support Clause. We’re going to start off with the
definition of an invention.
Then Bayh Dole Government Support Clause Requirements.
Acceptable and unacceptable Government
Support Clause Documents. Acceptable and unacceptable Government
Support Clauses.
And finally available resources for you in case you have any questions, issues, or concerns.
So what is an invention under the Bayh-Dole Act?
37 CFR Section 401 defines an invention as any invention or discovery which is or may be
patentable or otherwise protectable under the
US Code. A subject invention means any invention of the
contractor conceived or first actually reduced to
practice in the performance of work under the grant or contract. Now the Federal or
Government Support Clause. This is a statutory
requirement. 37 CFR 401 provides that: “The contractor agrees to include, within the
specification of any US patent applications and
any patent issuing thereon covering a subject invention the following statement. Now the
terms contract and grant and cooperative
agreement are interchangeable for the purposes of this presentation. Same goes for contractor,
grantee, and awardee.
Now note the quotation marks surrounding the Government Support Statement.
“This invention was made with government
support under (identify the grant number) awarded by (identify NIH). The government has
certain rights in the invention.”
Ok. For the initial patent application, the GSC, awarded by (identify NIH). The government has
certain rights in the invention.”
Ok. For the initial patent application, the GSC, it’s really just a fill in the blank exercise.
This is not a time for creative writing. It’s very
simple. You fill in the blanks. So, if there are leading zeroes in your grant number, include
them. So when you see “identify the contract” in
the Government Support Clause, include those leading zeroes.
There is an example for you on the screen.
Remember, zeroes are numbers too. Identify the Federal agency, this is the awarding
Federal agency. Not the institute or division
within that agency. For example we wouldn’t use the National Cancer Institute, we would use the
National Institutes of Health.
It may sound simple but it can get confusing. So, here’s a tip if you’re unsure which agency is your
awarding agency. Just look at your Notice of
Award. Now we’re going to move on to acceptable
documents that should contain the Government
Support Clause. Patent applications are submitted to the US
Patent and Trademark Office.
Provisional and Non-Provisional (or Utility) Applications.
Continuations. A continuation is a second
application for the same invention claimed in a prior non-provisional application and filed before
the first application becomes abandoned or
patented; Continuations-in-Part. A CIP is an application
filed during the lifetime of an earlier non-
provisional application; And Divisional Applications. Which is a later
application for an independent or distinct
invention disclosing and claiming only a portion of and only subject matter disclosed in the
earlier or parent application.
All Patent Applications containing the GSC must be uploaded along with, and this is important,
the USPTO Filing Receipt. The Filing Receipt is
an official document from the PTO letting us know that they received the application from you.
Why do we need that? We must be able to
determine whether what you provided in iEdison is the same thing that you provided to the US
Patent and Trademark Office.
So what are some unacceptable Government Support Clause Documents? Single sheets of
paper that contain only the Government Support
Clause. They don’t look like they were submitted to the USPTO in connection with any invention
whatsoever. And they look like they were simply
typed on a computer, printed, and uploaded. Secondly, documents that contain no evidence of
submission to the US Patent and Trademark
Office. One example that I’ve seen recently is a 33-page
document, it looks like a patent application but
there’s no cover sheet, nothing to indicate submission to the USPTO, no date stamps, no
Filing Receipt.
So if the document looks like it was simply typed into a word processing application, and printed
and uploaded and we don’t have any evidence
that it was submitted to the US Patent and Trademark Office, it will be rejected.
Unacceptable Government Support Clause
documents can also include documents that do not contain anything resembling a Government
Support Clause. And these are real examples.
A published article or a manuscript with an acknowledgement of federal funding but not a
Government Support Clause; an invention
disclosure; a confirmatory license; a receipt from a retail warehouse store (with a date); and a
recipe for Chicken Paprikash.
Alright. So maybe those last two weren’t real examples, but you get the idea.
Acceptable Government Support Clauses. An
acceptable patent application that contains the following language with the appropriate and
accurate information inserted where indicated in
place of the parentheticals. Now I’m going to read this to you because it’s very important.
“This invention was made with government
support under (identify the grant or contract) awarded by (identify the Federal agency (the NIH
in this case)). The government has certain rights
in the invention.” Again, this is a fill in the blank exercise.
And remember the quotation marks surrounding
the clause. There is no wiggle room. Adding conditional words such as may, or might, or
could have, or may have been, in part, a few . . .
they’re unacceptable. Don’t be creative. This is the language that’s
required for the Government Support Clause.
Some unacceptable Government Support Clauses. It must contain the grant numbers that
match the grant numbers in iEdison. If it doesn’t
match the grant numbers in iEdison, we will reject the Government Support Clause.
For example, if Edison has four grant numbers
and your Government Support Clause that you uploaded only has two, then we will reject the
Government Support Clause.
And conversely, if the GSC has four grant numbers and iEdison only has two, we will reject
your Government Support Clause.
And if the grant numbers in the Government Support Clause do not match what we have in
iEdison, we will reject your Government Support
Clause. OK, now we’re going to go into some examples
of unacceptable Government Support Clauses
Notice what’s highlighted in red and underlined. “This invention was made, (here it is) in part
(there’s that conditional language), with
government support under grant number HL002345 awarded by the National Institutes of
Health. The government has certain rights in the
invention.” This is where some creative writing came in and the fill in the blank rule was not
followed.
Another example, “This invention was made, in whole or in part (conditional language), with
government support under grant number
HL012345 awarded by the National Institutes of Health and the Alphabet Soup Foundation. (The
Alphabet Soup Foundation to my knowledge is
not a federal agency so we would keep that out). The government has a few rights in the
invention.”
Third, “This invention may have been made with government support under grant number
MH002345 awarded by the National Institute for
Mental Health.” Notice that the institute is inserted where the federal agency should be, so
it should be the National Institutes of Health
rather than the National Institute for Mental Health. A few more examples, “This invention
was made, in part, with government support
under (and there’s the grant number) awarded by the Federal government (as opposed to the
National Institutes of Health) The government
may have certain rights in the invention.” Again, no conditional language. The government does
have certain rights in the invention. Not “may
have.” The government has certain rights in the invention. Now we’re getting really creative. “This
invention may or may not have been made, in
whole or in part, with partial support under grant number MH2345 (notice the missing leading
zeroes in the grant number) awarded by the
National Institute for Mental Health. The government may have rights in the invention.”
And finally, “This invention could have possibly
been invented, with or without full or partial support under a grant made by the Department
of Transportation. The government may or may
not have partial rights in the invention.” Now, the example, the last example the lists the
Department of Transportation as the federal
agency. That would be ok if it also listed the National Institutes of Health and the grant
numbers. So, you get the idea. No creative
writing. And finally, this is your resource page. If you
have any questions about Government Support
Clauses or any iEdison-related issue, this is where you go.
Thank you for taking the time to view this webinar
and we hope it will be a valuable resource for
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you.

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