Reaping the Benefits of Genomic and Proteomic Research Intellectual Property Rights, Innovation, and Public Health (2006) / Chapter Skim
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5 Conclusions and Recommendations
5 Conclusions and Recommendations
Pages 133-149
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From page 133... ...
5 Conclusions and Recommendations T he previous chapters have described how the nature of molecular biology and the behavior norms of the scientific community have changed in the wake of the Human Genome Project (HGP) and the birth of proteomics.
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From page 134... ...
134 REAPING THE BENEFITS OF GENOMIC AND PROTEOMIC RESEARCH 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.
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From page 135... ...
. Nucleic acid sequences provide the fundamental starting point for describing and understanding the structure, function, and development of genetically diverse
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From page 136... ...
In addition, defensive patenting of three-dimensional structures of drug targets has the potential to interfere with drug discovery. Structural biology data in published patent applications and issued patents are presented in such a form that they are not readily incorporated into the Protein Data Bank (PDB)
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CONCLUSIONS AND RECOMMENDATIONS 137 Recommendation 2: The committee supports NIH in its efforts to adapt and extend the "Ber muda Rules" to structural biology data generated by NIH-funded cen ters for large-scale structural genomics efforts, and thereby making data promptly and freely available in a database via the PDB. Although in principle the coordinate data that are in patent applications could be put into the PDB, both the content and format of these patent applications are not suitable for incorporation into the repository.
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From page 138... ...
138 REAPING THE BENEFITS OF GENOMIC AND PROTEOMIC RESEARCH chemistry libraries, clones and cloning tools, databases, and software (under some circumstances) .2 The principles were developed in response to complaints from researchers that restrictive terms in material transfer agreements (MTAs)
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From page 139... ...
For example, the committee believes that it would be consistent with the NIH guidelines to discourage grantees and contractors from patenting three-dimensional macromolecular structures. For the sake of clarity, the committee does not believe that NIH grantees and contractors should be discouraged from patenting biological macromolecules that have been shown to have clear therapeutic value in their own right.
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140 REAPING THE BENEFITS OF GENOMIC AND PROTEOMIC RESEARCH ments. There are many precedents for voluntary compliance with such standards by industry, dating back to the voluntary submission of research protocols involving recombinant DNA, and more recently, gene transfer studies, to NIH's Recombinant DNA Advisory Committee for review.
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From page 141... ...
Understanding biological processes through the association of genetic variation with individual phenotypic differences and through structural analyses will involve a variety of methods (global medical sequencing and population genetics in the first and x-ray crystallography and nuclear magnetic resonance [NMR] spectroscopy in the second)
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Nonobviousness determinations require that one look to the prior art and assess whether a person of ordinary skills could replicate the invention, whether such a person would be motivated to do so, and whether he or she would have a reasonable chance of success. The previous National Academies' committee recommended that the Federal Circuit abandon the rule announced in Bell and Deuel that, essentially, prevents the consideration of the technical difficulty faced in obtaining pre-existing genetic sequences.
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From page 143... ...
It is not a reward for the search, but compensation for its successful conclusion." But the standard has not been applied in a consistent fashion. Some believe more recent decisions of the Federal Circuit have been less strict about the utility requirement, particularly as applied to biopharmaceutical inventions.
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From page 144... ...
Duke University, the Federal Circuit rejected the experimental use defense in the context of academic research, declaring the noncommercial character of the research to be irrelevant to its analysis of the case. The court found that research that is part of the "legitimate business" of the university is not protected "regardless of commercial implications" or lack thereof.4 The implications of this decision are not yet clear, although it would appear that researchers and their institutions will have to pay much closer attention to the intellectual property issues involved in their current and future work especially when that work is driven by commercial considerations.
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CONCLUSIONS AND RECOMMENDATIONS 145 is, investigator initiated, highly decentralized, and uncoordinated -- the implementation of an administrative structure that would deal prospectively with intellectual property issues in a manner similar to due diligence precautions in the private sector could impose burdensome administrative costs and strongly influence choices of academic research directions. At the same time, it is doubtful that such an apparatus could be effective in a university context.
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From page 146... ...
Recommendation 11: NIH should undertake a study of potential university, government, and industry arrangements for the pooling and cross-licensing of genomic and proteomic patents, as well as research tools. Such proposed sharing arrangements are being pursued in agricultural biotechnology by the Public Intellectual Property Resource for Agriculture and the Biological Innovation for Open Society initiative in different ways.
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From page 147... ...
The committee recognizes that diagnostic tests will sometimes involve such special circumstances and that there is a need to license more exclusively when the costs of test development or diffusion require the substantial investment of private capital. It is likely that with continued advancements in human genomics and the recognition of ever more statistical correlations between mutations in multiple genes and clinical phenotypes, opportunities for engaging in such restrictive practices will continue to multiply.
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148 REAPING THE BENEFITS OF GENOMIC AND PROTEOMIC RESEARCH freely available to the clinicians treating the patients. Thus, clinical research in the United States always has been intertwined with the practice of medicine by physician investigators in academic medical institutions, and historically, overages obtained from medical practice have been a significant source for investment and operating funds in clinical research.
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From page 149... ...
CONCLUSIONS AND RECOMMENDATIONS 149 gies to validate the results of particular clinical tests. The committee agreed that this may present a problem and encourages patent owners to consider entering into licenses that will permit others to use the patented technologies for the purpose of independently confirming the results of a diagnostic test.
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