NIH All About Grants Podcast

Title: Invention Reporting and Patent Protections

Released: July 2020

>> From the National Institutes of Health in Bethesda, Maryland, this is "All About Grants".�

>> Kosub:� Hello, and welcome to a virtual edition of NIH's "All About Grants" podcast, I'm your host, David Kosub, with the NIH's Office of Extramural Research, and so you have gotten your award, you did your research and you came up with a really new cool product, new invention, new something that you wanted to get patented, and you wanted to know what is NIH policies related to that, and what kind of protections do I have for that and how do I report that information in NIH?� Well, that's what we're going to be talking about today.�

We have with us today Mr. Scott Cooper, he is an Assistant Extramural Inventions Policy Officer at the NIH's Office of Extramural Research, and thank you for being with us, Scott.

>> Cooper:� Thank you, David.

>> Kosub: All right.� So let's jump right in.� What is intellectual property and how does it relate to the research that NIH supports on its grants?

>> Cooper:� Well, intellectual property covers creations of the mind.� It differs from real property or your personal property, and it's protected by laws, patents, trademarks, unfair competition, copyright and so forth, but we're primarily concerned about inventions and patent protection when it comes to inventions created with your federal dollars.

>> Kosub: And as all of this stems from the Bayh‑Dole Act, can you tell about the intent of that legislation?

>> Cooper:� Sure.� The Bayh‑Dole Act has been around since 1980.� It's been a term and condition of all federal funding agreements since then.� It was intended to do many things, to stimulate the economy, to ‑‑ it encourages small business participation in federal funding research, and promotes commercialization, public availability of inventions that are made with federal dollars, and it also ensures that the government obtains sufficient rights in the intellectual property that is supported by federal research monies.

>> Kosub:� How does it benefit the awardee?

>> Cooper:� Well, it used to be that the government owned inventions and patents that were made with government dollars, so there really wasn't much incentive for folks out there to seek federal funding in order to do their biomedical research, but what the Bayh‑Dole Act does, it allows awardees to own and to retain rights in their invention of patents.� It lets them benefit financially from their inventions and patents, and also benefit professionally with all the advantages that may come along with having a patented invention.

>> Kosub:� Following up on Bayh‑Dole just for another question, some folks may be aware that it was updated recently in the last couple of years.� Is there anything worth note to our awardees related to the updates?

>> Cooper:� Yeah, thanks, David.

�

The Bayh‑Dole Act was substantively changed really for the first time since 1980, a couple of years ago, and one key change was that the grantee now has to report what's called provisional patent applications.� They have to report those to the government.� Provisional patent applications didn't exist at all in 1980 when the Bayh‑Dole Act was enacted, so this really updated with current patent law, the Bayh-Dole Act.

>> Kosub:� Great.� Earlier you mentioned Bayh‑Dole was a term and condition of award.� Can you tell us more about how Bayh‑Dole intersects with NIH Grants Policy Statement which is something that all of our awardees must abide by?

>> Cooper:� Sure, the Bayh‑Dole Act is incorporated into the NIH Grants Policy Statement as a term and condition of the award, so in addition to the statutory requirements contained within the Act, it is also incorporated into your award as a grant term.� So you can find the Bayh‑Dole Act referenced in particular sections of the grant policy statement.� It's in Sections 8.2, 8.3, and 8.4 of the Grants Policy Statement.� Specifically, in section 8.2.4, it provides that unless waived by the NIH, or if the funding is for educational purposes, fellowships, for example, training grants, the Bayh‑Dole Act applies to all NIH Research and Development Funded awards that are granted to for‑profit organizations regardless of size, and all nonprofit entities as well?

>> Kosub:� Cool.� Now let's jump into some of the nuts and bolts of this.� How does someone report an invention to NIH that is the result of one of our funded grants?

>> Cooper:� We report using the iEdison Reporting System. It's located at iEdison.gov. And it's an electronic database for grant recipients who report their inventions to us. They report their inventions, their patents and other documents that are associated with invention and patent reporting.�

We hold regional NIH seminars, usually once or twice a year, and our office provides a full‑day workshop about intellectual property and specifically the Bayh‑Dole Act and iEdison reporting, and we also offer one‑on‑one sessions to our grantees.

>> Kosub:� Definitely encourage folks to participate in those if they have questions on this.� So you mentioned some information that needs to be reported or talking about reporting.� What information from the invention needs to be reported, and I guess that�s the same as disclosure?

>> Cooper:� Right. So the grantees report their inventions to us, and as part of that, obviously we need to know what the invention is, so you report the name of the invention.� We also want to know the names of the inventors who are named inventors on this invention, who was responsible for creating this intellectual property.� When did the invention get reported to your institution?

And all federal grant numbers that funded the invention, not only NIH's grant numbers, but all federal grant numbers, and that's very important because we need to link your invention to that federal funding mechanism so we can know what was invented using which federal dollar pool.� So it's very important that we have those federal grant numbers.

�

For NIH, it consists of a two‑letter institute code, like HL for the heart, lung and blood institute, and a six‑digit grant number, and the six‑digit number is very important, because it's part of that grant number. We can't assume that if you report a five‑digit number to us, that that first number is a missing zero. And I kind of liken that to the analogy of my Social Security number.� Mine starts with a zero, and if I fill out a loan application and I forget that first zero on my Social Security number in the application, they're going to reject my application, because they don't know which number is missing out of my nine Social Security numbers.�

And it's the same thing with a grant number, because we may need to search that grant number if any questions or concerns come up.

>> Kosub:� So with regard to publications and public disclosures of an invention, once the invention gets out there, it's out there.� Can you talk more about that?

Like, is there any sort of protections at that point?

>> Cooper:� First of all, the Bayh‑Dole Act requires that you report your invention, your publications and your public disclosures to us, so that's a very good reason to report them.� Secondly, once that invention is disclosed publicly, patent law says you have a year in which to file your patent application, or that invention, and if you don't, you lose your rights.� So the Bayh‑Dole Act says that if you have a publication, you need to report that to the federal agency so we know when your rights may expire because of the publication.�

So, for example, we've had many instances where there's an article that's published in a journal, and it discloses the invention in its entirety.� All of the details about what it is and how it's used and how it came to be, and two or three years later, a patent application is filed.�

Well, because the invention was publicly disclosed in that article, the institution, the inventors, had no legal rights in that invention anymore because they expired.� So patent law precludes patent protection, so we need to know when that ownership rights cease to exist for the grantee.�

The one year after the data publication that's entered into that iEdison system, the status of that invention turns to bard. It's over. The grantee can no longer edit the record, create patent records; there are no more rights in the invention.

>> Kosub:� so, Someone goes through the process of reporting their inventions to us, in iEdison, would we reject one of those disclosures?

>> Cooper:� We could. We would reject it for a number of reasons.� I mentioned earlier some of the items of information that need to be reported; the name of the invention, the names of the inventors, the grant numbers. Also NIH requires annual commercialization and utilization reports, and we require a very technical description of the invention.� For example, there's no description of the invention; we only have a name.� The Bayh‑Dole Act requires that a very specific, detailed, technical description of the invention be reported to us, and if we don't have that technical description, then the invention disclosure may be rejected for that reason.

>> Kosub:� So it sounds like the ‑‑ you guys have an opportunity to fix a problem, but what happens if they never resolve it?

>> Cooper:� Yeah, there are some consequences if it's not resolved, but we do offer the grantee many opportunities to correct mistakes if they have them.� We send notification messages to them.� We send multiple alerts.� We're available via phone and e‑mail to assist our grantees in helping them become compliant, so if, for example, the disclosure is not resolved or it's not accepted and we do reject it, then we would work with the grantee to help them determine why it was not accepted and assist them in becoming compliant.

>> Kosub:� Inventions, they're the bread and butter of our grantees, and so they're probably weary, you know, of providing this information, what kind of protections is NIH giving us?� Can you talk a little bit about that?

>> Cooper:� You want to know what protections the NIH provides awardees?

Well, the invention disclosures themselves, they're not subject to release under the Freedom of Information Act.� So many grantees are free to disclose to us because they fear that it would open up their inventions to a public disclosure that would limit their rights, when in fact the opposite is true.� If they don't report their invention to us, they risk violating the terms and conditions of their award and they risk violating the Bayh‑Dole Act, so when they report to us all of that detail, it's not considered a public disclosure that would negatively impact the grantee's patent rights, but we maintain their protection through their disclosure with us.

>> Kosub:� I see.� You mention that some information is protected from being released publicly.� What information in that case might be releasable and where could that be found?

>> Cooper:� Well, their invention disclosures are not released, but any patent information that is provided on the NIH's research portfolio online reporting tools, Expenditures and results or RePORTER website, so it's any information that has been public.� So if there are nonprovisional patent applications, those are otherwise public on the US Patent and Trademark Office's website, so that information would be public.�

The grant numbers that were used to fund the invention are included in the patent applications and in the issued patents, so that information is public.� But the detail and the manner in which these inventions are disclosed to us are not public and not the ‑‑ the provisional patent applications are not public unless they are published by the US Patent and Trademark Office, which doesn't do so until there's a nonprovisional patent application or a issued patent.

>> Kosub:� And you kind of touched on this early on.� Does NIH actually have any claim to any inventions that are supported by our funded research?

>> Cooper:� Yes, that's a great question, because that's what a lot of folks who are unfamiliar with the Bayh‑Dole Act and NIH are concerned about.� And, yes, the NIH does receive a government use license.� We don't own the invention or the patent.� The grantee owns the invention and patent, but we do get a license.� It's nonexclusive.� It's nontransferable.� It's irrevocable.� And it's a paid‑up license for the government to practice or have the invention practiced on its behalf throughout the world.�

And this license is filed with the US Patent and Trademark Office, so if anybody wants to research the patent, they would be made aware of the government's rights.�

The iEdison system will create the license for the grantee to sign, either physically or electronically, and then that license will be filed with the US Patent and Trademark Office, and it grants the license to the government and provides notice to the world that the government has the license, but we do not compete with the grantee, and we do not commercially market the grantee's invention.� The ownership remains with them.� We're allowed to use it.

>> Kosub:� Before we go, the ‑‑ you touched a little bit about noncompliance and ‑‑ with regards to someone who is not reporting their inventions.� Can you give some additional thoughts on that?� Like are there any other ramifications NIH can take if someone is not compliant?

>> Cooper:� Sure.� There's a two‑pronged approach to noncompliance, so first you have the Bayh‑Dole Act, and there are remedies that are available in the Bayh‑Dole Act, but also because compliance with the Bayh‑Dole Act is a government condition of the federal award, then there are grant‑related remedies that are available, which may include restricting future funding or revoking current funding.� Those are really extreme remedies that we would undertake.� We like to stress that this is a non-adversarial process.�

Our goal is to make the research available to the public when appropriate and to make sure that there is proper stewardship of federal funds, and we're not out to play gotcha' with the grantees.� We want to ensure that when they intend to properly comply, we assist them with that.� We've had many instances of grantees who were severely noncompliant for many different reasons, staffing changes.� They've had problems with compliance for whatever reason it is, and literally thousands of iEdison noncompliant notification messages with a single grantee.� And we've worked with the grantees.� We've educated them.� We've helped them to understand what their notification messages mean, and we helped assist them in remedying those notification messages.�

So now those grantees that were severely noncompliant are now some of our most compliant grantees, and they continue to be compliant for years because they have a better understanding of what the requirements are and how the NIH enforces.� So we've helped them by reducing their time spent correcting errors, and it's also helped us reduce our time that we spend reviewing and rejecting submissions.

>> Kosub:� Wonderful.� So before we close, any final thoughts?� This is the opportunity to kind of tell the community some important things to leave with about invention reporting and patent protections that we do at NIH.

>> Cooper:� Great, thanks, David, I appreciate the opportunity to do that.� Yeah, I encourage our grantees to really educate themselves, to go to our website.� We have a very robust Frequently Asked Questions page.� We have information available on the iEdison help page, and, you know, we have the same goals as you do:� Stewardship of federal taxpayer dollars, advancing the wonderful medical research that's done out there in the field benefiting the public and benefiting the research community.

So educate yourselves, and when you have issues or concerns, please give us a call or an e‑mail, and we're more than happy to discuss individual questions and concerns and try to help you become compliant and maintain compliance so you achieve your goals and we can achieve our goal.

>> Kosub:� Very cool.� Thanks, Scott.� Appreciate this opportunity to hear more about NIH's policies related to intellectual property, invention reporting, and patent protections.� And as Scott mentioned, for more information, please do visit our grants web page.� You can look for intellectual property policies.� You can look at the help pages on the iEdison tool.� And you can also send an e‑mail to [email protected]. And with that, thank you very much.� This has been David Kosub with NIH's all about grants. Thank you.

>> Cooper:� Thank you.�