A. PURPOSE

This Manual Chapter establishes procedures for proper review and disposition of requests by contractors to allow employee inventors to retain title to extramural inventions.

B. BACKGROUND

The Office of Technology Transfer (OTT) has been delegated the authority permit a contractor (as defined by 37 C.F.R. 401.2(b) to include any party to a funding agreement, including a grantee) to grant requests by an inventor for retention of title to a subject extramural invention when the Government has insufficient interest in the invention to obtain the right, title, and interest therein (35 U.S.C. §202(d)). The following procedures are to be followed in processing and responding to such requests for title.

C. POLICY

It is the policy of the National Institutes of Health (NIH) to allow a contractor employee inventor to retain title to extramural inventions at the request of the contractor where the OTT determines either that 1) the invention has insufficient commercial or public health value to be of interest to the Government; or 2) the invention will be appropriately commercialized without Government intervention and is not sufficiently related to any NIH intramural research to warrant Government intervention.

1. The extramural institution will submit a request for title to the NIH Office of Extramural Research (OER), having first waived its rights to title in accordance with established procedures.

2. The OER will send a copy of the cover letter from the extramural institution to the Technology Development Coordinator (TDC) of the appropriate Institute or Center (IC) for reference and a copy of the original request and invention disclosure to the OTT.

3. Requests received by the OTT will be evaluated with regard to the nature of the invention and the Government's interest in either electing title or allowing the employee inventor to retain title. Factors that the OTT may consider in recommending whether a waiver will be granted include:
   1. potential public health benefits of the invention;

   2. patentability of the invention and enforceability of a patent once one is obtained;

   3. the stage of development and potential practical application of the invention, including the state of the markets or potential commercial markets;

   4. whether allowing the employee inventor to retain title would interfere with any Government interests in similar or related technology;

   5. whether waiver fosters rapid and appropriate commercialization of the invention, particularly with regard to inventions primarily useful as research tools; and

   6. whether the inventor has demonstrated a willingness and ability to commercialize the invention, and adhere to other requirements, by signing and submitting the Inventor Certification provided by OER (currently located on the EDISON extramural reporting database system).

4. OTT will convey a recommendation to the funding ICD, and seek the concurrence of the ICD through the TDC. Such concurrence shall include consultation by the TDC with the component of the agency which funded the invention.

5. The TDC shall provide a response either concurring or not concurring with the OTT recommendation within two weeks of receiving the recommendation. If the ICD is in disagreement with the OTT recommendation a dialogue shall be initiated to determine the final action that shall be taken.

6. Upon agreement of the action to be taken, the OTT will make a determination on behalf of the government, and communicate to the OER OTT's determination. The OER will communicate the determination to the contractor. Documentation of the request for waiver and disposition of the request will reside on the Edison extramural database, administered by OER.

E. EFFECTIVE DATE

The policy and procedures set forth in this Manual Chapter are effective immediately. All previous procedures are superseded.

F. ADDITIONAL INFORMATION

For additional information, contact the Office of Technology Transfer, (301) 496-7057.