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The SBIR program has successfully achieved many of the goals of the Bayh-Dole Act by promoting the utilization of inventions arising from Federally supported research, bringing these products to market and encouraging maximum participation of small business firms. We anticipate similar results from the STTR program in the near future. In the past, concern has been expressed that many of the inventions made with SBIR funding have not been reported to the National Institutes of Health (NIH) in compliance with the Bayh-Dole Act and related policies. This letter is just a reminder to award recipients of their invention reporting responsibilities to NIH.
As the Federal statutes and regulations that cover patent and invention issues and the entire notion of invention reporting in compliance with the Bayh-Dole Act may seem daunting, NIH has made efforts to clarify and simplify the steps involved in the invention reporting process. A very good starting point is to refer to a publication, entitled, "A '20-20' View of Invention Reporting to the National Institutes of Health" ( http://grants.nih.gov/grants/guide/notice-files/not95-003.html ), which was published in the NIH Guide for Grants and Contracts (September 22, 1995). A summary of grantee/contractor invention responsibilities, which provides information on the time limits placed by law and identifies specific invention reporting actions that must be taken, is available on the internet at the following URL: https://s-edison.info.nih.gov/iEdison/timeline.jsp.
In addition, I am including information that describes some principal features of the Bayh-Dole Act, as implemented by 37 CFR 401.14, the Standard Patent Rights Clause. This clause is a part of the SBIR and STTR funding agreement and its full text can be found at https://s-edison.info.nih.gov/iEdison/37CFR401.jsp#401-14 or at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm ("Part II: Terms and Conditions of NIH Grant Awards-Part 5 of 7" of the NIH Grants Policy Statement, Inventions and Patents). Under the Act, principle worldwide patent rights to an invention supported in whole or in part with Federal funds (called a "subject invention") may be retained by the grantee/contractor. However, award recipients must promptly report to the Government all subject inventions made under the grant or contract. These subject inventions include not only new inventions made during the SBIR or STTR award, but also inventions on which a patent application may have been previously filed, but which have been first actually reduced to practice under the SBIR or STTR grant/contract. When the grantee/contractor organization retains title to a subject invention, the Federal Government must be provided a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the subject invention throughout the world. It is important to recognize that reporting of the information in NO WAY CONSTITUTES PUBLIC DISCLOSURE, and the information will be kept in strictest confidence. Also, be reassured that the Government license in no way allows the Government to compete with the grantee/contractor for licensing of the invention. A confirmatory license should be submitted to the NIH, and once received, the NIH sends the license to the US Patent and Trademark Office for recordation. A model confirmatory invention license is available online at http://www.iedison.gov/Edison/license.html.
Reporting of inventions should be done prior to any publication or presentation of the invention at an open meeting, since failure to report at the appropriate time is a violation of 35 USC 202, and may result in loss of the rights of the small business concern, inventor, and Federal Government in the invention. Generally, all foreign patent rights are immediately lost upon publication or other public disclosure unless a United States patent application is already on file. In addition, statutes preclude obtaining valid United States patent protection after 1 year from the date of a publication that discloses the invention.
NIH must be notified within 2 months of the inventor's initial report to the grantee/contractor organization to the Division of Extramural Inventions & Technology Resources (DEITR), Office of Policy for Extramural Research Administration (OPERA), NIH, at the address below. The reporting of inventions can be accomplished electronically through the NIH Interagency Edison Invention Reporting System. Use of the Edison system satisfies all mandated invention reporting requirements and access to the system is through a secure interactive Web site (http://www.iedison.gov) designed to ensure that all information submitted is confidential. In addition to fulfilling reporting requirements, Edison notifies the user of future time-sensitive deadlines with enough lead-time to avoid the possibility of loss of patent rights due to administrative oversight. Edison can accommodate the invention reporting needs of all organizations. For additional information about this user-friendly invention reporting and tracking system, visit the Edison home page cited above or contact Edison via e-mail at firstname.lastname@example.org .
If there is some reason you are unable to use Edison, you should contact:
Director, Division of Extramural Inventions & Technology Resources (DEITR)
Office of Policy for Extramural Research Administration (OPERA)
National Institutes of Health (NIH)
6705 Rockledge Drive, Suite 310, MSC 7980
Bethesda MD 20892-7980
At the time of filing a patent application, the award recipient agrees to include within the specification of any U.S. patent application or patent issued, the following statement, "This invention was made with government support under (grant/contract number) awarded by (institute, agency). The Government has certain rights in the invention." NIH requires that a copy of the page of the patent application containing this Federal support clause be sent to OPERA/DEITR. Finally, if the grantee or contractor does not elect to retain title to the invention or decides not to continue the prosecution of the patent application, pay maintenance fees, or defend a reexamination or opposition proceeding on the patent, the Government must be notified within the time limits specified in the patent rights clause in the event that the Government may decide to take title.
While I have tried to highlight the more salient features of invention reporting, you are encouraged to become familiar with other specific invention reporting actions as outlined in the extramural invention reporting compliance responsibilities timeline (https://s-edison.info.nih.gov/iEdison/timeline.jsp). If you need additional information or have questions related to invention reporting, please contact the Division of Extramural Inventions & Technology Resources (DEITR) at (301) 435-1986.