. "HISTORICAL PERSPECTIVES ON GOVERNMENT TECHNOLOGY TRANSFER POLICY AND THE PHARMACEUTICAL INDUSTRY." Government and Industry Collaboration in AIDS Drug Development. Washington, DC: The National Academies Press, 1994.
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Government and Industry Collaboration in AIDS Drug Development: Summary of a Workshop Held on May 6, 1994
various agencies and departments followed their own patent guidelines or policies. In 1955, the U.S. Department of Health, Education, and Welfare (HEW)—the parent department of NIH—promulgated regulations spelling out its approach to patent rights. HEW (now the U.S. Department of Health and Human Services [DHHS]4) took the position that inventions supported in any way by federal funds should generally be dedicated to public use or, if patented, be made available to the public on a nonexclusive and royalty-free basis. Accordingly, HEW freely published the results of most NIH-sponsored research and dedicated many inventions to public use.
HEW recognized, however, that it is sometimes necessary to use the patent process “to foster an adequate commercial development to make an invention widely available.” Toward this end, HEW's 1955 regulations allowed the U.S. Surgeon General to enter into Institutional Patent Agreements (IPAs) with grantee institutions. These agreements permitted the institutions themselves to determine the ownership and disposition of patent rights, as long as the inventions were made available to the public without unreasonable restrictions or excessive royalties. Between 1953 and 1958, NIH entered into IPAs with 18 private institutions, primarily universities. HEW added more leeway in 1957, when it ruled that contracts with private industry for cancer chemotherapy research would not be subject to the presumption against privately owned patent rights.
The first effort to establish a uniform patent policy for the federal government came in 1963, when President Kennedy issued a memorandum 5 stating that the government should generally acquire the principal or exclusive rights to inventions derived from federally supported research. IPAs would be permitted only in exceptional situations, and although it was not stated specifically, the intent seemed to be that IPAs would not apply to research or inventions that affect the public's health or welfare. Although many agencies remained flexible in their interpretations of the Kennedy memorandum and continued to routinely assign patent rights to private contractors, HEW did otherwise. The Department declined to enter into IPAs with any of the 34 institutions that made requests during this period, and almost never assigned grantees or contractors the patent rights to inventions.
In 1968, the U.S. General Accounting Office (GAO) issued a report 6 stating that HEW's policy of retaining patent rights deterred industry from cooperating
The National Institutes of Health are part of the U.S. Public Health Service (PHS), which is part of DHHS.
President John F. Kennedy, Memorandum and Statement of Government PatentPolicy, October 10, 1963.
U.S. General Accounting Office, Problem Areas Affecting Usefulness of Results ofGovernment-Sponsored Research in Medicinal Chemistry, GAO Report B-164031(2), August 12, 1968.