Policies & Reports
Policies & Reports
- United States Public Health Service Technology Transfer Manual Chapter No. 307 -- NIH Procedures for Handling Requests for Reconsideration and Appeals of Licensing Decisions
- NIH CRADA Report on Reasonable Pricing Clause, 1994
- NIH Notice Rescinding Reasonable Pricing Clause, 1995
- NIH's Response to the USPTO FITF Guidelines
- SACGHS report on Gene Patents and Licensing Practices and Patient Access to Genetic Tests (Feb 2010)
- GAO Report GAO-09-742 – Information on the Government's Right to Assert Ownership Control over Federally Funded Inventions
- Article: John H. Rabitschek and Norman J. Latker, Reasonable Pricing - A New Twist for March-in rights Under the Bayh-Dole Act, 22 Santa Clara Computer & High Tech. L.J. 149 (2005)
- Article: Barbara M. McGarey and Annette C. Levey, Patents, Products, and Public Health: An Analysis of the CellPro March-In Petition, 14 Berkeley Technology Law Journal (1999)
- Federal Laboratory Technology Transfer - FY 2009 Summary Report to the President and the Congress (March 2011)
- Best Practices for the Licensing of Genomic Inventions - Final Notice (April 2005)
- Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts (Reprinted from the Federal Register, Vol. 59, No. 215, Tuesday, November 8, 1994, pp. 55674-55679)
- NIH Conflict of Interest Policy
- NIH Data Sharing Policy
- Uniform Biological Material Transfer Agreement: Discussion of Public Comments Received; Publication of the Final Format of the Agreement (Published in the Federal Register on Wednesday, March 8, 1995, Vol. 60, No. 45, pp. 12771-12775)
Court Cases
NIH Research Tools Guidelines
Memoranda of Understanding
- NIH/DuPont OncoMouse Memorandum of Understanding
- NIH/DuPont Crelox Memorandum of Understanding
- PHS/WiCell Amended and Restated Memorandum of Understanding
- PHS/WiCell Amended and Restated Memorandum of Understanding - Simple Letter Agreement
NIH March-In Response
- NIH decision on Xtandi march-in request
- March-In Determination in the case of Fabrazyme
- Fabrazyme March-In Close-Out Letter (February 2013)
- March-In Position Paper in the case of Xalatan
- March-In Position Paper in the case of Norvir
- NIH Public Meeting in the case of Norvir (May 25, 2004)
- March-In Determination in the case of Norvir (November 2013)
- March-In Determination in the case of CellPro
Congressional Interest in NIH Technology Transfer
- NIH Response to the Conference Report Request for a Plan to Ensure Taxpayers' Interests are Protected (July 2001)
- GAO Report RCED-99-242 – Technology Transfer: Reporting Requirements for Federally Sponsored Inventions Need Revision (August 1999)
- GAO Report RCED-99-173 – Technology Transfer: Number and Characteristics of Inventions Licensed by Six Federal Agencies (June 1999)
- Report to Congress on Affordability of Inventions and Products (July 2004)