Licensing Process

1. Find the specific technology to license.

The preferred way to search for technologies developed in the laboratories at the NHLBI and the Office of Technology Transfer and Development (OTTAD) client Institutes is by using OTTAD Technology Search, a live search engine for locating technologies by keyword or taxonomy classification. Another option for locating NHLBI and OTTAD client Institute technologies is by searching the Federal Register. Preliminary discussions may lead to detailed discussions with the researcher/inventor and a Licensing and Patent Manager (LPM).  These discussions can be covered by a Confidential Disclosure Agreement (CDA), and executed by OTTAD. A CDA also may be obtained through the LPM if a party wants a copy of an unpublished patent application that covers the technology of interest.

2. Submit a License Application.

If a company is interested in licensing a technology developed by NHLBI or an OTTAD client Institute, it should contact the OTTAD Licensing and Patent Manager listed under the technology abstract, to obtain guidance on completing and submitting an Application for License. This required Application serves as the primary basis for licensing decisions, by providing OTTAD with the following:

  1. the potential licensee
  2. the type of license desired by the potential licensee
  3. some of the terms desired by the potential licensee
  4. the potential licensee's plans for development and commercialization of the invention

Also, if the applicant desires a license with some form of exclusivity, the completed application provides OTTAD with the applicant's justification for an exclusive license.

Note: Confidential commercial or financial information provided in a license application is considered business confidential and is exempt from disclosure under the Freedom of Information Act (FOIA) (5 USC §552(b)).

3. Review of the License Application by OTTAD.

After reviewing the license application, OTTAD determines if the applicant's proposal is consistent with the licensing strategy developed for the invention and whether the grant of the license would benefit the public and be consistent with the interests of the Federal Government.

If the applicant has requested a nonexclusive license and a favorable determination has been made upon the application by OTTAD Licensing and Patenting Managers, then negotiations will begin as appropriate.

If the applicant has requested an exclusive or partially-exclusive license, OTTAD will publish a notice in the Federal Register, as required by law. After a 15-day period to receive comments on the proposed grant of an exclusive or partially-exclusive license, OTTAD will re-evaluate the application and all comments to make a final determination regarding the license. The criteria to be considered in evaluating exclusive license applications (37 CFR §404.7) include whether:

  • exclusive licensing serves the best interests of the public,
  • practical application of the invention is likely to be achieved under a nonexclusive license,
  • an exclusive or partially-exclusive license is a reasonable and necessary incentive to promote the investment of risk capital to bring the invention to practical application,
  • exclusive or partially-exclusive license terms and conditions are not broader than necessary,
  • exclusive licensing will not lessen competition, and
  • preference is for "equally as likely" small businesses.

4. The following are used as evaluation criteria for Exclusive License Applications by OTTAD:

  • Proposed field of use and its availability
  • Proposed research, development and commercialization plan and market analysis (37 CFR 404.5)
  • Infrastructure (Full-Time Equivalents [FTEs], financial position, core competency and commitment to bring product and/or service to market)
  • Statutory criteria

5. Publishing of Intent to Grant Exclusive Notice in Federal Register for period of 15 days by OTTAD.

  • Opportunity for others to comment and/or object
  • Possible outcomes if valid objection in the form of a license application
    • Co-exclusive or partial (territory, FOU) exclusive license
    • Collaborate or partner with one another
    • Grant or deny a license to one or more parties
    • Non-exclusive license for all

6. Final Determination by OTTAD.

If no objections are received or resolved during the Notice Period, OTTAD makes a Final Determination to negotiate and finalize a license.