Excerpt

Avoiding a conflict between open dissemination and access to scientific discoveries and the protection of inventors' rights is critical to furthering scientific progress and enhancing human health. It also is critical that as science evolves, we stop to assess whether the appropriate mechanisms to prevent such a conflict remain in place. This report is just such an assessment—a marker in time that looks at the state of genomic and proteomic research and the current policies and practices promoting or restricting the dissemination of scientific information, tools, and products, and asks, "are there any storms over the horizon?"

Contents

• The National Academies
• Committee on Intellectual Property Rights in Genomic and Protein Research and Innovation
• Board on Science, Technology, and Economic Policy
• Committee on Science, Technology, and Law
• Preface and Acknowledgments
• Summary
  • OVERALL CONCLUSIONS
  • BEST PRACTICES AND NORMS FOR THE SCIENTIFIC COMMUNITY AND FEDERAL RESEARCH SPONSORS
  • ADAPTING THE PATENT SYSTEM TO THE DEVELOPING FIELDS OF GENOMICS AND PROTEOMICS
  • FACILITATE RESEARCH ACCESS TO PATENTED INVENTIONS THROUGH LICENSING AND SHIELDING FROM LIABILITY FOR INFRINGEMENT
• 1. Introduction
  • THE PUSH TO PATENT
  • SCIENCE AND COMMERCE
  • PATENT ISSUES
  • SECRECY VERSUS OPENNESS
  • THE ILLUSORY EXPERIMENTAL USE EXEMPTION
  • CHARGE TO THE COMMITTEE
  • ORGANIZATION OF THE REPORT
• 2. Genomics, Proteomics, and the Changing Research Environment
  • THE IMPORTANCE OF DNA SEQUENCE
  • THE HUMAN GENOME PROJECT
  • HUMAN GENETIC VARIATION
  • WHAT ARE GENOMICS AND PROTEOMICS?
  • THE IMPORTANCE OF PROTEIN STRUCTURE
  • CHANGING SCIENTIFIC AND CLINICAL PARADIGMS
  • INTELLECTUAL PROPERTY AND COMMERCIALIZATION
  • SCIENTIFIC NORMS AND EVOLVING SCIENCE POLICIES
  • SUMMARY
• 3. The U.S. Patent System, Biotechnology, and the Courts
  • FIELDS OF ACTIVITY
  • APPLICABLE LAW
  • CONCLUSIONS
• 4. Trends in the Patenting and Licensing of Genomic and Protein Inventions and Their Impact on Biomedical Research
  • TRENDS IN PATENTING GENOMIC AND PROTEIN INVENTIONS
  • TRENDS IN UNIVERSITY LICENSING OF GENOMIC AND PROTEOMIC INVENTIONS
  • EFFECTS OF INTELLECTUAL PROPERTY PRACTICES ON RESEARCH
  • SHARING RESEARCH MATERIALS
  • CONCLUSION
• 5. Conclusions and Recommendations
  • OVERALL CONCLUSIONS
  • BEST PRACTICES AND NORMS FOR THE SCIENTIFIC COMMUNITY AND FEDERAL RESEARCH SPONSORS
  • ADAPTING THE PATENT SYSTEM TO THE DEVELOPING FIELDS OF GENOMICS AND PROTEOMICS
  • FACILITATE RESEARCH ACCESS TO PATENTED INVENTIONS THROUGH LICENSING AND SHIELDING FROM LIABILITY FOR INFRINGEMENT
• References
• Appendixes
  • Appendix A Biographical Information of Committee and Staff
  • Appendix B Search Algorithms Used to Identify Patents of Interest

This study was supported by Contract No. N01-OD-4-2139, between the National Academies and the National Institutes of Health. In addition, the study was supported by Affymetrix Inc., Agilent Technologies, Amgen, Biotechnology Industry Organization, Chiron Foundation, Pfizer Inc., and the Bellagio Center of the Rockefeller Foundation. The views presented in this report are those of the National Research Council Committee on the Intellectual Property Rights in Genomic and Protein Research and Innovation and are not necessarily those of the funding agencies.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.