done with an entire battery of tests, both blocking and an anti-commons might be in effect.

CONCLUSION

After reviewing the existing research literature and conducting research on (1) issued patents and published patent applications in a subset of biotechnology categories; (2) a small set of university licensing practices of selected categories of patents; and (3) biomedical research scientists’ experiences with intellectual property and its effects on research, the committee identified four areas of concern.

First, the apparent lack of substantial evidence for a patent thicket or a patent-blocking problem is associated with a general lack of awareness or concern among investigators about existing intellectual property. This situation could change dramatically as institutions increasingly realize that they enjoy no legal protection and concerns are raised about possible patent infringement liability; this may lead them to take more steps to raise awareness and regulate their behavior.

Second, although the survey did not reveal significant differences in experience between investigators working independently and those working in multimember teams, the growing complexity of biomedical research may make intellectual property more problematic as work on a single gene or gene sequence gives way to research entailing far more extensive inputs, more and more of them patented.

Third, the licensing of some gene-based diagnostic tests does appear to be having an inhibiting effect on research and related clinical practice.

Finally, impediments to the exchange of research materials among laboratories exist, although these impediments appear to be largely independent of intellectual property. Instead, they are associated with scientific competition and the lack of rewards for the time and effort entailed in meeting requests for research inputs and academic respondents’ commercial interests.



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