Patents Part Two—A Closer Look at Reporting

This follow-up piece to our March 17, 2021 article “Insights Into Inventions—Reporting, Bayh-Dole, and More” is recommended reading if you are an investigator whose NIH-funded research leads—or has led—to an invention.

In this article, we cover types of patent applications, invention reporting requirements, and compliance advice. But first, a word to the wise.

Patent Before Public Disclosure

When it comes to your invention, you should be thinking “first comes patent, then comes public disclosure.”

In other words, before publicly disclosing any details of your invention, such as in a publication, apply for a patent.

It’s important to know that a “publication” does not have to be an article or paper nor does it need to be in writing since “publish” means to share information—including orally—with a third party without a confidentiality agreement. That means you can publish your invention by discussing it with someone at dinner or a conference presentation. 

Also remember that submitting a required invention disclosure to NIH through Interagency Edison (iEdison) is not considered a “public disclosure” and will not jeopardize your patent rights. In fact, if you don’t submit a required invention disclosure to NIH, your patent rights will be in jeopardy.  

In the event you fail to file a patent application before publicly disclosing your invention, there may be a shred of hope for you. If you file your patent application within one year after publicly disclosing your invention and no one else files a patent application before you do, then your rights may be protected.

Patent Applications: The Big Three

You may file several types of patent applications; we focus on three of the major ones: provisional, nonprovisional, and international applications under the Patent Cooperation Treaty (PCT).

For more detailed information, go to Types of Patent Applications and Proceedings on the United States Patent and Trademark Office (USPTO) website.

Provisional Application

This type of application gives you a quick, inexpensive way to protect your invention and establish a U.S. filing date for it.

A provisional application is effective for 12 months from the date you file it. During that year, you can conduct more research or refine your invention, but before the 12 months are up, you must file a corresponding nonprovisional patent application to benefit from the earlier provisional application filing.

However, the Bayh-Dole Act now requires you to file your nonprovisional patent application within 10 months of filing your provisional application. You may request an extension beyond the 10 months from NIH.

Note the following:

• You must include a specific reference to the provisional application in your nonprovisional application.
• Making a public disclosure (e.g., publication, public use, offer for sale) more than one year before the provisional application’s filing date would preclude patenting in the United States.

Nonprovisional Application

As mentioned above, a nonprovisional application is what you have to file before your provisional application is null and void; i.e., before its 12-month period ends, but 10 months for Bayh-Dole compliance.

If your nonprovisional application is approved, USPTO may issue you a patent that protects your invention for a limited time by excluding others from activities such as making or selling it.

PCT Application

You may want to pursue an international application under the PCT to protect your invention in several countries at one time.

The World Intellectual Property Organization (WIPO) defines the PCT as

“...an international treaty with more than 150 Contracting States.* The PCT makes it possible to seek patent protection for an invention simultaneously in a large number of countries by filing a single ‘international’ patent application instead of filing several separate national or regional patent applications. The granting of patents remains under the control of the national or regional patent Offices in what is called the ‘national phase’.”

*For a list, go to The PCT Now Has 153 Contracting States on the WIPO website.

Invention and Patent Reporting

You’ll recall from our previous article that 1) the Bayh-Dole Act of 1980 requires all government-funded inventions be reported to the awarding federal agency, e.g., NIH, and 2) you must use iEdison to electronically report all NIH-funded invention disclosures, patent applications and patents, and related reports or documents.

Required compliance documents for invention and patent reporting include, but are not limited to, the following:

• Final Invention Statement (HHS 568) (grant closeout, not submitted in iEdison)
• Invention Report and “Disclosure” (invention records)
• Government Support Clause (GSC) (patent records)
• Confirmatory License (CL) (patent records)
• Annual Utilization Reports (invention records for all inventions regardless whether patent applications are filed)

For a complete list and descriptions, go to section 8.2.4. Inventions and Patents in the NIH Grants Policy Statement.

Common Compliance Errors

For the documents above, compliance problems will be minimal if you avoid these errors:

Final Invention Statement (HHS 568)

• All inventions listed in your HHS 568 are not reported in iEdison and vice versa.

Invention Report and “Disclosure”

• The disclosure describes what the inventors hope to prove, not the invention created with NIH grant funds.
• Not all awards included on the disclosure were entered into iEdison.
• Not all awards entered into iEdison are included in the disclosure.
• Award numbers are incorrect.
• Not all inventors listed in the disclosure are entered into iEdison and vice versa.
• Invention title in the disclosure is completely different from the invention title entered into iEdison.
• Date of First Publication, Sale, or Public Use field is not populated, if applicable.
  • Disclosure references a publication and the field is not populated.
  • Disclosure includes a publication and a publication date and the field is not populated.
  • Disclosure includes a manuscript that has no publication date and does not indicate “Not Published” on the cover page of the manuscript.
  • Publication includes authors who are not inventors but not noted as such on the publication.

Government Support Clause

• Language in the GSC does not match the required Bayh-Dole language.
• Grant numbers do not match or are missing.
• Government agency that awarded the grant is missing or incorrect. The agency is the “National Institutes of Health.” If only the “National Institute of Allergy and Infectious Diseases” is provided, the GSC will be rejected.
• The GSC provides conditional language, for example, “The government may have certain rights. . .” instead of “The government has certain rights. . .”

Confirmatory License

• Title does not match the invention record or the patent record.
• Inventors listed on the CL do not match the inventors listed in the patent record.
• Grantee provides filing/issue date for a different patent application.
• Grantee lists multiple patent applications and issued patents on one CL.
• Grantee lists a PCT patent application number in the “foreign applications filed/intended in (countries)” field, instead of the names of the countries.
• The execution date is not legible, institutional business officer is missing, title of institutional business officer is missing, and/or business address is missing.
• Grantee provides department name/research foundation instead of grantee/contractor organization name.

Annual Utilization Reports

• Reports are not submitted.

Whom To Contact With Questions

First, touch base with staff in your institution's technology transfer office. In addition to answering your questions, they can also inform you of institution-specific policies and procedures.

For additional assistance on invention and patent reporting compliance, rights and responsibilities, email edison@nih.gov to contact the Division of Extramural Inventions and Technology Resources in NIH’s Office of Policy for Extramural Research Administration (OPERA).

You may also want to check out the iEdison & Intellectual Property FAQs and Resources and iEdison—Online Help, User Guides & Release Notes.