OVERALL CONCLUSIONS

The committee found that the number of projects abandoned or delayed as a result of technology access difficulties is reported to be small, as is the number of occasions in which investigators revise their protocols to avoid intellectual property complications or pay high costs to obtain access to intellectual property. Thus, for the time being, it appears that access to patents or information inputs into biomedical research rarely imposes a significant burden for academic biomedical researchers. However, for a number of reasons, the committee concluded that the patent landscape, which already is burgeoning in areas such as gene expression and protein-protein interactions, could become considerably more complex and burdensome over time.

There are reasons to be concerned about the future. First, the lack of substantial evidence for a patent thicket or a patent blocking problem clearly is linked to a general lack of awareness or concern among academic investigators about existing intellectual property. That could change dramatically and possibly even abruptly in two circumstances. Institutions, aware that they enjoy no protection from legal liability, may become more concerned about their potential patent infringement liability and take more active steps to raise researchers’ awareness or even to try to regulate their behavior. The latter could be both burdensome on research and largely ineffective because of researchers’ autonomy and their ignorance or at best uncertainty about what intellectual property applies in what circumstances. Alternatively, patent holders, equally aware that universities are not shielded from liability by a research exception, could take more active steps to assert their patents against them. This may not lead to more patent suits against universities—indeed, established companies are usually reluctant to pursue litigation against research universities—but it could involve more demands for licensing fees, grant-back rights, and other terms that are burdensome to research. Certainly, some holders of gene-based diagnostic patents are currently active in asserting their intellectual property rights. Even if neither of these scenarios materializes, researchers and institutions that unknowingly and with impunity infringe on others’ intellectual property could later encounter difficulties in commercializing their inventions.

Finally, as scientists increasingly use the high-throughput tools of genomics and proteomics to study the properties of many genes or proteins simultaneously, the burden on the investigator to obtain rights to the intellectual property covering these genes or proteins could become insupportable, depending on how broad the scope of claims is and how patent holders respond to potential infringers. The large number of issued and pending patents relating to gene-expression profiling and protein-protein interactions contributes to this concern.

More immediately, the survey data revealed substantial evidence of another, potentially remediable burden on private as well as public research stemming from difficulties in accessing proprietary research materials, whether patented or



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