Fact: Thomas Edison held over 2,000 patents worldwide, including more than 1,000 U.S. patents.
Should you develop a unique or novel device, method, or process during the course of your NIH-funded research, you would have two things in common with Edison: being an inventor and wanting (presumably) exclusive rights to your invention by obtaining a patent.
That said, Edison did not make his discoveries using funds from NIH grants after 1980 and therefore did not have to comply with the Bayh-Dole Act nor report his inventions to NIH, the awarding agency. You, however, do.
What To Do First
If your funded research leads to an invention, communicate with staff in your institution's technology transfer office as soon as possible.
Timing is important, so promptly contact them once you think you have made a patentable discovery and before publicly disclosing such information.
That leaves time for you and your institution to discuss patenting your invention and filing a patent application if necessary.
Get Caught in the Bayh-Dole Act
If you haven’t already, familiarize yourself with Public Law 96-517; 35 U.S.C. 200-212, commonly known as the Bayh-Dole Act of 1980. In a nutshell, it states that funding recipients, e.g., grantees, have the right to retain title to inventions made under federally funded research but must comply with regulations (37 CFR 401 et seq.) to ensure the timely transfer of the technology to the public sector.
Under the Bayh-Dole Act, your institution as the grant recipient owns rights to the NIH-funded invention and has the right and obligation to patent under the Bayh-Dole Act. However, if it chooses not to, you (the inventor) may be allowed to—with NIH approval—submit a patent application to the United States Patent and Trademark Office (USPTO). This is called an “Inventor Waiver.” Your technology transfer office will be able to guide you through either procedure (your institution’s proceeding with a patent or your applying for an Inventor Waiver).
You can start by filing an inexpensive provisional application, but you will need to follow through with a nonprovisional U.S. or international (Patent Cooperation Treaty or "PCT") application within one year of the provisional application's filing date.
For patent-related expenses, see USPTO’s Fees and Payment.
As we mentioned above, the Bayh-Dole Act requires that all government-funded inventions be reported to the awarding federal agency; in your case, NIH.
You must electronically submit all invention disclosures and related reports or documents using Interagency Edison (iEdison).
For a brief summary of required items your institution must provide, go to Reporting Requirements During Your Grant. Find a more exhaustive list with timeframes at iEdison's Invention Reporting Timeline: At a Glance.
We’ll cover some of these reporting requirements in greater detail in an upcoming issue.
Where To Turn With Questions
Your first point of contact should be staff in your institution's technology transfer office. They can answer questions and also inform you of institution-specific policies and procedures.
For additional assistance on invention and patent reporting compliance and responsibilities, email email@example.com to contact the Division of Extramural Inventions and Technology Resources (DEITR) 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.