industry respondents, the key reported reasons were the need to protect commercial value and the consumer’s unwillingness to accept restrictive terms.

Gene-Based Diagnostic Test Patents

An area where patents seem to be having an inhibitory effect on research and related clinical practice involves gene-based diagnostic tests (see Chapter 2 for a discussion of breast cancer diagnostics). This was not a focus of the committee’s survey, in part because Mildred Cho and colleagues (2003) have conducted telephone surveys of U.S. clinical laboratory directors who were members of the Association for Molecular Pathology. The first concern is that a patent owner’s refusal to make a single patented gene available for licensing on reasonable terms will inhibit follow-on research on the incidence of mutations in the gene as well as limit patient access to testing at a reasonable cost and the possibility of obtaining a second opinion on the result. Exclusive licenses also limit the opportunity for the development of improvements in the test and verification of the result. An anti-commons effect also can be anticipated in the future as clinicians begin to develop tests for multigenic traits.

Cho and colleagues’ sampling frame of 211 laboratory directors combined listings in the most recent Association of Molecular Pathology directory and on the genetests.org website maintained by the University of Washington with federal funding. The result was a sample of corporate, university, private hospital, federal government, and other nonprofit laboratories. They analyzed the responses of 122 individuals, a large majority of whom had licenses to perform genetic tests for a wide variety of conditions, including hereditary breast and ovarian cancer (BRCA1/2), Canavan Disease, Hereditary Hemochromatosis, and Fragile X syndrome, among others.

The results suggest that holders of gene-based diagnostic patents are active in asserting their intellectual property rights. Sixty-five percent of respondents reported having been contacted by a patent or license holder regarding their potential infringement in performing a test. Twenty laboratories had received notification for 1 test; 51 had received notifications for up to 3 tests, and 26 laboratories for 4 or more tests. These enforcement efforts focused on 12 tests that, as a result, 1 or more laboratories had ceased to perform. In all, 30 laboratories responded that they had ceased administering at least 1 test. This number included almost all of the corporate laboratories and about one-quarter of university laboratories. Asked to evaluate their experience, respondents indicated that patents had had a negative effect on all aspects of clinical testing and reported a decline in information sharing between laboratories. Inclination to undertake test development, too, was adversely affected, according to respondents. Thus, patents do appear to be blocking the clinical use of tests insofar as such clinical use is closely related to follow-on research. Because clinical research often is more efficiently



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