mittee.1 It builds on a more limited interview-based survey by Walsh, Cohen, and Ashish Arora—work carried out for the National Academies’ predecessor Committee on Intellectual Property Rights in the Knowledge-Based Economy (NRC, 2003). The new survey represents the first systematic effort to shed light on the concerns expressed by members of the academic community that patents on upstream discoveries may impede follow-on research and development if access to the foundational intellectual property is restricted or is too difficult, time consuming, or costly to obtain. The new survey goes further, however, to try to determine the extent of biomedical researchers’ involvement with intellectual property, its role—positive as well as negative—in decisions to initiate, redirect, or suspend research, and investigators’ experience with sharing of research data and materials, whether or not protected by intellectual property. The survey achieved a modest response rate and is subject to the limitations of an inquiry relying on memory and self-reporting, but its results are largely consistent with the findings of the earlier nonrandom interviews. The results of these inquiries and the committee’s interpretation of those results and of closely related studies are presented in this chapter.

TRENDS IN PATENTING GENOMIC AND PROTEIN INVENTIONS

Although not the only source of data on genomic and proteomic patents,2 the most extensive database of U.S. “gene” patents was initiated by the congressional Office of Technology Assessment in the early 1990s with assistance from the United States Patent and Trademark Office (USPTO) and Georgetown University scholars and was transferred to Georgetown University, where it is maintained and continually updated with the support of the National Institutes of Health (NIH) and the Department of Energy. Using a proprietary patent database, Delphion, the investigators have compiled a comprehensive set of patents from several broad biology-related patent classes. These are patents that refer to nucleic acids and closely related terms assembled into an algorithm to search in their claims. From 1971 until 2006, approximately 33,000 issued nucleic acid patents have been identified. The annual rate of patenting did not exceed 500, however,

1  

The full report, J. Walsh, C. Cho, and W. Cohen, Patents, Material Transfers, and Access to Research Inputs in Biomedical Research, June 2005, is available at http://www.uic.edu/~jwalsh/NASreport.html.

2  

See also A.M. Michelsohn, Biotechnology Innovation Report 2004: Benchmarks and Biotechnology Innovation Report. Washington, DC: Finnegan, Henderson, Farabow, Garett & Dunner, LLP. These sources have reported numbers and ownership of patents in several biotechnology categories, identified by key word searches. The results are not incompatible with those described below, but the use of carefully delineated search algorithms yields more discriminating results than do keyword searches.



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