In 1993, the U.S. Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., laid out a new test for federal trial judges to use when determining the admissibility of expert testimony. In Daubert, the Court ruled that judges should act as gatekeepers, assessing the reliability of the scientific methodology and reasoning that supports expert testimony. The resulting judicial screening of expert testimony has been particularly consequential. While the Supreme Court sought to bring better science into the courtroom, questions remain about whether the lower courts' application of Daubert accords with scientific practices. This report summarizes discussions held by an ad hoc committee of the The National Academies to consider the impact of Daubert and subsequent Supreme Court opinions and to identify questions for future study.
The patenting and licensing of human genetic material and proteins represents an extension of intellectual property (IP) rights to naturally occurring biological material and scientific information, much of it well upstream of drugs and other disease therapies. This report concludes that IP restrictions rarely impose significant burdens on biomedical research, but there are reasons to be apprehensive about their future impact on scientific advances in this area. The report recommends 13 actions that policy-makers, courts, universities, and health and patent officials should take to prevent the increasingly complex web of IP protections from getting in the way of potential breakthroughs in genomic and proteomic research. It endorses the National Institutes of Health guidelines for technology licensing, data sharing, and research material exchanges and says that oversight of compliance should be strengthened. It recommends enactment of a statutory exception from infringement liability for research on a patented invention and raising the bar somewhat to qualify for a patent on upstream research discoveries in biotechnology. With respect to genetic diagnostic tests to detect patient mutations associated with certain diseases, the report urges patent holders to allow others to perform the tests for purposes of verifying the results.
National Research Council. 2006. Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health. Washington, DC: The National Academies Press.
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