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is thought to arise from divergent attitudes regarding intellectual property rights and patent policy (Sederoff and Sederoff, 1996). The academic tradition of publishing research results is incompatible with industry's proprietary and competitive concerns.

Another, related area of tension has to do with the experimental-use exemption provided for under the act, which is intended to foster freer use of patented biotechnology for non-profit research by academic institutions. Industry is resistant to the exemption, a position some analysts feel will be prejudicial to university-based science (Sederoff and Sederoff, 1996).

Yet another issue has to do with overhead costs. Bayh-Dole stipulated that an industry entering into partnership with an academic institution would cover overhead costs. Recently, however, industry concerns with cost cutting have generated some unwillingness to pay all overhead costs (Terry, 1996). There are also many issues surrounding the appropriate allocation of funds that require clarification.

All these issues suggest that there is a need for further refinement of guidelines for collaborative agreements of the sort contemplated under the act (Schimmel, 1996).

References

Schimmel P. A two-way street between the university and the biotechnology enterprise. Journal of NIH Research 8(8):41-43, 1996.

Sederoff R, and M Sederoff. Taq polymerase and the experimental-use exemption. Journal of NIH Research 8(8):43-44, 1996.

Sherman C, and S Englund. When the feds share the tab. Legal Times, 15 May 1995. (Lexis-Nexis, Allnews, Bayh-Dole).


Terry WD. The academic-industrial complex: Doing well and doing good. Journal of NIH Research 8(8): 39, 1996.

Orphan Drug Act

Background

In 1983 Congress amended the federal Food, Drug, and Cosmetics Act with the Orphan Drug Act (ODA/PL 97-414). The ODA was created to provide incentives for companies to develop therapies that otherwise would not be commercially viable because they are needed only by a relatively small number of patients. The act was intended to prompt the pharmaceutical industry to develop drugs for use against rare diseases affecting fewer than 200,000 people in the United States. The incentives for industry include research grants, a 50-percent income-tax credit on most clinical research expenditures, assistance with FDA approval, and exclusive license to market the product for 7 years immediately



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