1. steps that NIH and others might take to ensure the productivity of research and innovation involving genes and proteins.

Under the auspices of NAS’s Science, Technology, and Economic Policy Board and Committee on Science, Technology, and Law, a study committee was formed in response to this charge. The committee reviewed the literature in the field, held several public sessions that included presentations by experts and stakeholders, and conducted a survey of how biomedical research scientists acquire, use, and experience intellectual property practices. Based on these sources of information, the committee drew conclusions and made recommendations in three broad areas that aim to ensure that the public investment in genomics and proteomics results in optimal public benefit:

  • improving and facilitating best practices and norms in the conduct of genomics and proteomic research:

  • adapting the patent system to the rapidly changing fields of genomics and proteomics; and

  • facilitating research access to patented inventions through licensing and shielding from liability for infringement.

The committee was not asked to and did not directly address issues in the acquisition and management of and access to intellectual property involving plants and animals. Clearly, differences in the scale and diversity of research and in the distribution of patent ownership between agricultural and human biotechnology exist, and these variations may merit separate study. Nevertheless, there has been comparable progress in plant molecular biology. Gene-based diagnostics also are important for monitoring crop and farm animal diseases. All of these have been subjects of patenting in the same manner as human DNA sequences, genes, and proteins. The committee suggests that, when these similarities warrant, it may be appropriate to apply to animal and plant biotechnology comparable policies and principles to those that it recommends for biomedical research and development.

OVERALL CONCLUSIONS

The committee found that the number of projects abandoned or delayed as a result of difficulties in technology access is reported to be small, as is the number of occasions in which investigators revise their protocols to avoid intellectual property issues or in which they pay high costs to obtain intellectual property. Thus, for the time being, it appears that access to patented inventions or information inputs into biomedical research rarely imposes a significant burden for biomedical researchers. For a number of reasons, however, the committee concluded that the patent landscape, which already is becoming complicated in areas such as



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