gene expression and protein-protein interactions, could become considerably more complex and burdensome over time.

There are several reasons to be cautious about the future. The lack of substantial evidence for a patent thicket or a patent-blocking problem is associated with a general lack of awareness or concern among academic investigators about existing intellectual property. That could change dramatically and possibly even abruptly under two circumstances. First, institutions, as they become aware that they may enjoy no protection from legal liability,1 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 the autonomy of academic researchers and their ignorance—or at best uncertainty—about what intellectual property laws apply in what circumstances. Alternatively, patent holders, aware that universities are not especially shielded by law from patent infringement liability, could take more active steps to assert their competing patents. This may not lead to more patent suits against universities or between companies—indeed, established companies usually are 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 currently are active in asserting their intellectual property rights.

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 could become insupportable.

Perhaps most importantly, the results of the survey conducted with the support of the committee revealed substantial evidence of a more immediate and potentially remediable burden on research—private as well as public—stemming from difficulties in accessing proprietary research materials, whether patented or unpatented. The committee found that impediments to the exchange of biomedical research materials remain prevalent and may be increasing.

Several steps may be taken to anticipate and prevent the emergence of an

1  

The situation for state institutions is more complex and may provide state institutions with greater protection. Under the 11th Amendment states enjoy immunity from suits in federal courts for monetary damages absent either their express consent or a legitimate congressional grant of the power to sue in federal court. Although a state can be enjoined from continuing to infringe, Congress only can abrogate 11th Amendment immunity if it is remedying a failure by the states to provide adequate compensation for unauthorized past usage, in this case, the failure to provide legitimate protection of rights through the state’s courts. To be deemed adequate the state courts must, however, provide both due process for petitioners and the possibility of redress.



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