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Scientists' discoveries are the fruits of their labors and with luck will be published in prominent journals. These discoveries also represent intellectual property (IP) that may need to be protected in order to preserve value and utility in the future.
With regards to your research findings, what measures have you put in place to safeguard IP developed under your grant or used as preliminary data in a grant application?
If you haven't yet considered such precautions, you've come to the right place. We'll show you how to ensure that what's rightfully yours stays that way.
Note: in most cases, IP developed by an investigator whose research is funded by an NIH grant is owned by his or her employer, though the investigator retains certain rights as the inventor.
When it comes to sharing information about IP, remember the saying "Better safe than sorry."
In other words, keep details under wraps—and here's an important caveat—unless you have a formal safeguard (e.g., a confidential disclosure agreement, an issued patent, a filed patent application, or a copyright) in place. This includes when you're applying for a grant.
If you don't follow our caveat above, these two simple tips can help you avoid difficulties down the road.
When you write your grant application, consider whether you absolutely need to include the confidential information to succeed during peer review, and work closely with your office of technology development to determine the best way to protect your intellectual property.
Also keep in mind that parts of your funded application can be released under the Freedom of Information Act (FOIA), if requested. Learn more at Confidentiality of Information in the NIH Grants Policy Statement (GPS).
Copyright Data and Publications
In general, you have the rights to publications or data developed under an NIH grant—including training and fellowship awards—and may copyright them without NIH approval unless your Notice of Award explicitly says otherwise.
Keep in mind that copyright ownership is an arrangement between you and your institution. As the grantee, your institution may exercise its right of ownership over any work created during your official duties. Also note that journals have copyright control over materials you publish with them.
For more information, go to the GPS's 8.2.1 Rights in Data (Publication and Copyrighting).
Get Protection for Your Invention
If you create an invention under your grant, you should be aware of some key points regarding inventions, patents, and associated reporting requirements.
Let's be patent-ly clear
Should your funded research lead to an invention, your first instinct might be to let anyone and everyone know about it through publications and at conferences.
Not so fast.
You should tell your institution's technology transfer office as soon as possible—once you think you have made a patentable discovery, and certainly before publicly disclosing such information. That leaves time for you and your institution to discuss patenting your invention.
Note that your institution can patent intellectual property. If it chooses not to, you (the inventor) may be allowed to submit a patent application to the United States Patent and Trademark Office (USPTO), though it is an expensive process.
You can file 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.
Patent Law Changing
Next year, U.S. patent law will move from the current "first-to-invent" system to a "first-inventor-to-file" system for patent applications filed on or after March 16, 2013.
As the name of the new rule implies, the first inventor ("A") to file a patent application for an invention will normally get that patent, assuming that the application meets the law’s requirements for patentability. However, a one-year grace period related to public disclosures could mean that the second inventor ("B") to file may still be granted the patent.
For example, if B independently publishes on the invention within a year of filing his or her own patent application but before A’s application filing date for the same invention, that publication could threaten the novelty of A's application but not B's.
The term "novelty" is explained at USPTO's Novelty And Non-Obviousness, Conditions For Obtaining A Patent.
For details on the new law, go to America Invents Act.
The Bayh-Dole Act requires that all government-funded inventions be reported to the awarding federal agency, e.g., NIH.
If you don't comply with reporting requirements, you could lose the rights and title to any inventions made during your grant, and NIH may withhold grant funds or take other enforcement actions.
Your institution's reporting requirements include submitting an invention disclosure and an annual utilization report for every invention to which the institution has elected title. Your technology transfer office can submit this and other information electronically through iEdison for NIH and other participating federal agencies and programs.
Find a brief summary of required items your institution must provide at Invention Reporting Has Four Parts in the Strategy for NIH Funding.
For a more exhaustive list with timeframes, go to iEdison's Extramural Invention Reporting Compliance Responsibilities.
Where to Turn With IP and Reporting 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, contact either of the following:
Good news: NIH renewed its Commercialization Assistance Program (CAP), which is now open to both Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) phase II awardees (grants and contracts).
Act fast if you're interested in the program since there are only two weeks left until the November 7 deadline. That said, you won't need much time to complete the convenient online application, which should take no more than an hour or so. To get started, go to Register for NIH-CAP 2012-2013.
To help you achieve your commercialization goals, CAP provides one-on-one mentoring, training workshops, access to industry experts, and networking opportunities.
That's not all. The program has two tracks to meet the needs of companies at different levels of commercialization experience and expertise:
You are eligible if your SBIR or STTR phase II award is active or was active in the past five years. If your company is among the 75 selected, you will start the program in December and finish in August 2013.
Be sure to read complete details and application instructions at Commercialization Assistance Program (CAP) for Phase II SBIR and STTR Awardees.
If you liked our October 10, 2012, article "Sidestep These Application Missteps: Misfiring on Innovation," we have more good news.
You now can go to Sidestep These Application Missteps, a new page with the information covered in our nascent article series.
The resource covers quotes, quibbles, and qualifiers from some of our program and scientific review officers. It also links to more detailed facts and advice in our Strategy for NIH Funding.
As we write subsequent articles in the series, we will update the page so you can keep it as a handy reference or share with your colleagues and postdocs.
Do you have any aspects of a grant application you'd like us to cover? Email us at email@example.com.
Fact: everyone grows older. But how does our immune system change as we slowly march towards our golden years?
If you’re interested in pursuing research in this important area, NIAID has a new funding opportunity for you.
This request for applications (RFA) focuses on understanding immune protection mechanisms—induction, development, and maintenance—in response to infections with or vaccines against NIAID's Emerging and Re-emerging Infectious Diseases during the aging process. It seeks to answer the question: what immunological changes affect our response to infection and vaccines as we age?
Note that human studies are required in at least one Specific Aim.
Also be aware that if you plan on using samples from repositories, make sure you pay special attention to instructions in the funding opportunity announcement.
For full details, see the September 28, 2012, Guide notice. Optional letters of intent are due by January 18, 2013, and the application due date is February 20, 2013.
You can find more information on human subjects process and policy on the NIAID Human Subjects Resources page.
As the saying goes, time flies. Case in point: we last wrote about NIH's Loan Repayment Programs (LRP) in August, and now we're only three weeks away from the application deadline of November 15.
In addition to the impending due date, note that NIAID supports only the Clinical Research LRP and Pediatric Research LRP out of the several repayment programs NIH offers.
For some of the benefits of LRP and helpful resources, read our August 15, 2012, article "Sending Out an S.O.S. About Student Loans? NIH's LRP to the Rescue."
If you have questions and can't find answers on NIH's LRP site or ours at Loan Repayment Programs, contact NIAID's LRP liaison Katrin Eichelberg.
To all who generously volunteered to serve on peer review committees and our Advisory Council in FY 2012, thank you.
And if you are an experienced investigator, please help us fund the best science: volunteer to join an NIAID peer review group. You could serve your scientific community while gaining invaluable insights into the review process.
Learn more at How to Volunteer for a Review Committee.
Are you on the lookout for new research areas we consider high-priority?
See our latest concepts approved by our advisory Council at its September meeting.
Concepts are the early stage of a potential initiative—a request for applications (RFA), program announcement, or contract solicitation. We use them to stimulate research in high-priority areas of science, and some have money set aside to fund the awards.
Though there's no guarantee we'll issue a funding opportunity announcement for any of the concepts Council approves, we post them so you know what areas of research our program divisions view as urgent or opportune.
Go to Concepts: Potential Initiatives for a list of concepts from the last six Council meetings, organized by extramural program division.
For more about how concepts work, read Concepts May Turn Into Initiatives in the NIAID Funding Opportunity Planning and the Budget Cycle.
For more about Council, visit our Advisory Council portal and read NIAID's Council—Our Chief Advisory Committee.
Check out the new eRA Training page, designed to make it easier for you to navigate the eRA system.
You’ll find training modules with Web-based tutorials, presentations, and other handy tips and guidance on the following topics:
eRA plans to continue adding modules as resources become available.
The new page replaces the Virtual School you may have had bookmarked that housed these resources for many years.
Do you have feedback about the page? Email eRACommunications@mail.nih.gov.
Feel free to send us a question at firstname.lastname@example.org. After responding to you, we may include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.
"Do you know of a Web site that helps PIs and business offices understand the various parts of the Notice of Award?"—Barbara Y. Croft, Ph.D., Duke Medicine
These two resources may help:
Your assigned grants management specialist can also answer questions. He or she is listed in the Notice of Award and in the eRA Commons.
"Should I include diversity supplements when calculating a PI's salary cap?"—Ashley Lee, University of Missouri
No. PIs do not receive salary support from diversity supplements. Funds go directly to students, postdocs, and faculty scientists who are brought onto a project under the supplement.
For more on NIAID's diversity supplements, read Research Supplements to Promote Diversity in Health-Related Research.
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Last Updated October 24, 2012
Last Reviewed October 24, 2012