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

• Public Citizen Health v. National Institutes of Health

NIH Research Tools Guidelines

• Research Tools – NIH Principles and Guidelines for Sharing of Biomedical Resources – Final (Published in the Federal Register on Thursday, December 23, 1999, Vol. 64 No. 246, pp. 72090-72096)

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)