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Full-Text Articles in Law
Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen
Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen
Articles
In 2015, one of us published a peer-reviewed study, together with colleagues at the University of California, San Francisco, replicating prior research from the US Food and Drug Administration (FDA) detecting a designer stimulant, β-methylphenylethylamine, in sports, weight loss, and “cognitive function” supplements sold in the United States. The confirmatory study prompted the FDA to take enforcement action against companies selling the stimulant as a dietary ingredient. One of the companies that received an FDA warning letter sued the study’s authors for $200 million in damages for libel, claiming, without supporting scientific evidence, that multiple statements in the article were …
Symposium: Examining Shaken Baby Syndrome Convictions In Light Of New Medical And Scientific Research, David A. Moran
Symposium: Examining Shaken Baby Syndrome Convictions In Light Of New Medical And Scientific Research, David A. Moran
Articles
I've been asked to react to Professor Findley's talk, and I just wanted to try to put this in a concrete format that we can understand. In the summer of 2001, when my oldest daughter was about six months old, I put her in a backpack (the kind that you strap to your back) to go for a hike. In trying to get her out of that backpack after the walk, I dropped her, and she landed on her head, and she very briefly lost consciousness. So I rushed her to the University of Michigan Medical Center in Ann Arbor, …
Noncompliance, Nonenforcement, Nonproblem? Rethinking The Anticommons In Biomedical Research, Rebecca S. Eisenberg
Noncompliance, Nonenforcement, Nonproblem? Rethinking The Anticommons In Biomedical Research, Rebecca S. Eisenberg
Articles
A decade ago the biomedical research community was sounding alarm bells about the impact of intellectual property (IP) rights on the ability of scientists to do their work. Controversies and delays in negotiating terms of access to patented mice and genes, databases of scientific information, and tangible research materials all pointed toward the same conclusion: that IP claims were undermining traditional sharing norms to the detriment of science. Michael Heller and I highlighted one dimension of this concern: that too many IP rights in "upstream" research results could paradoxically restrict "downstream" research and product development by making it too costly …
Preparing For Climatic Change: The Water, Salmon, And Forests Of The Pacific Northwest, Philip W. Mote, Edward A. Parson, Alan F. Hamlet, William S. Keeton, Dennis Lettenmaier, Nathan Mantua, Edward L. Miles, David W. Peterson, David L. Peterson, Richard Slaughter, Amy K. Snover
Preparing For Climatic Change: The Water, Salmon, And Forests Of The Pacific Northwest, Philip W. Mote, Edward A. Parson, Alan F. Hamlet, William S. Keeton, Dennis Lettenmaier, Nathan Mantua, Edward L. Miles, David W. Peterson, David L. Peterson, Richard Slaughter, Amy K. Snover
Articles
The impacts of year-to-year and decade-to-decade climatic variations on some of the Pacific Northwest’s key natural resources can be quantified to estimate sensitivity to regional climatic changes expected as part of anthropogenic global climatic change. Warmer, drier years, often associated with El Niño events and/or the warm phase of the Pacific Decadal Oscillation, tend to be associated with below-average snowpack, streamflow, and flood risk, below-average salmon survival, below-average forest growth, and above-average risk of forest fire. During the 20th century, the region experienced a warming of 0.8 ◦C. Using output from eight climate models, we project a further warming of …
Understanding Climatic Impacts, Vulnerabilities, And Adaptation In The United States: Building A Capacity For Assessment, Edward A. Parson, Robert W. Corell, Eric J. Barron, Virginia Burkett, Anthony Janetos, Linda Joyce, Thomas R. Karl, Michael C. Maccracken, Jerry Melillo, M. Granger Morgan, David S. Schimel, Thomas Wilbanks
Understanding Climatic Impacts, Vulnerabilities, And Adaptation In The United States: Building A Capacity For Assessment, Edward A. Parson, Robert W. Corell, Eric J. Barron, Virginia Burkett, Anthony Janetos, Linda Joyce, Thomas R. Karl, Michael C. Maccracken, Jerry Melillo, M. Granger Morgan, David S. Schimel, Thomas Wilbanks
Articles
Based on the experience of the U.S. National Assessment, we propose a program of research and analysis to advance capability for assessment of climate impacts, vulnerabilities, and adaptation options. We identify specific priorities for scientific research on the responses of ecological and socioeconomic systems to climate and other stresses; for improvement in the climatic inputs to impact assessments; and for further development of assessment methods to improve their practical utility to decision-makers. Finally, we propose a new institutional model for assessment, based principally on regional efforts that integrate observations, research, data, applications, and assessment on climate and linked environmental-change issues. …
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Articles
Allowing universities to patent the results of government-sponsored research sometimes works against the public interest.
Public Vs. Proprietary Science: A Fruitful Tension?, Rebecca S. Eisenberg, Richard R. Nelson
Public Vs. Proprietary Science: A Fruitful Tension?, Rebecca S. Eisenberg, Richard R. Nelson
Articles
What should be public and what should be private in scientific research? The competitive sprint of public and private laboratories to complete the sequence of the human genome has brought this question to the fore. The same question frames the developing struggle over terms of access to human embryonic stem cell lines and the conflict between Microsoft and the open source movement over how best to promote software development. We expect such conflicts to become more widespread as the role of for-profit research expands in a broader range of scientific fields. Will science progress more swiftly and fruitfully if its …
Re-Examining The Role Of Patents In Appropriating The Value Of Dna Sequences, Rebecca S. Eisenberg
Re-Examining The Role Of Patents In Appropriating The Value Of Dna Sequences, Rebecca S. Eisenberg
Articles
As public and private sector initiatives race to complete the sequence of the human genome, patent issues have played a prominent role in speculations about the significance of this achievement. How much of the genome will be subject to the control of patent holders, and what will this mean for future research and the development of products for the improvement of human health? Is a patent system developed to establish rights in mechanical inventions of an earlier era up to the task of resolving competing claims to the genome on behalf of the many sequential innovators who elucidate its sequence …
Sticks And Stones, Phoebe C. Ellsworth
Sticks And Stones, Phoebe C. Ellsworth
Articles
I believe that research should be refuted by research. More and more of our scarce journal space is being taken up by attacks, rebuttals, and rebuttals to the rebuttals, often ending with a whimper of recognition that the adversaries were not so very far apart to begin with, and that the only way (if possible) to resolve the disagreement is through empirical research. Communication of scientific disagreement does not require a published article. Grant proposals and manuscripts submitted to refereed journals like this one are sent out to reviewers, who provide written evaluations that are communicated to the author. Papers …
Intellectual Property At The Public-Private Divide: The Case Of Large-Scale Cdna Sequencing, Rebecca S. Eisenberg
Intellectual Property At The Public-Private Divide: The Case Of Large-Scale Cdna Sequencing, Rebecca S. Eisenberg
Articles
The Human Genome Project provides fertile ground for studying the role of intellectual property at the wavering boundary between public and private research science. It involves a major commitment of both public and private research funds in an area that is of significant interest both to research scientists working in university and government laboratories and to commercial firms. It thus provides a wealth of new scientific discoveries that are simultaneously potential candidates for commercial development and inputs into further research. Its obvious implications for human health raise the stakes of getting the balance between private property and public access right, …
A Technology Policy Perspective On The Nih Gene Patenting Controversy, Rebecca S. Eisenberg
A Technology Policy Perspective On The Nih Gene Patenting Controversy, Rebecca S. Eisenberg
Articles
This article will use the NIH patent controversy as a focal point for considering when the results of government-sponsored research should be patented and when they should be dedicated to the public domain. First, this article will review the recent history of federal government policy on patenting the results of government-sponsored research. Next, this article will highlight some of the complexities involved in achieving technology transfer from the public sector to the private sector that current policy may oversimplify. With this background, this article will return to a more detailed analysis of the NIH cDNA patenting controversy and consider the …
Patenting The Human Genome, Rebecca S. Eisenberg
Patenting The Human Genome, Rebecca S. Eisenberg
Articles
The increasing promise of federal funding for mapping and sequencing the human genome has brought with it renewed attention in the research science community to issues of intellectual property protection for products of biotechnology research. Echoing concerns raised a decade ago in the debate over commercialization of academic biomedical research, scientists have called for the free availability of all information generated through the Human Genome Project and have argued against allowing private intellectual property rights in such knowledge. Meanwhile, private parties have quietly been obtaining patents on bits and pieces of the human genome from the Patent and Trademark Office …
Patents And The Progress Of Science: Exclusive Rights And Experimental Use, Rebecca S. Eisenberg
Patents And The Progress Of Science: Exclusive Rights And Experimental Use, Rebecca S. Eisenberg
Articles
In this article I analyze the proper scope of an experimental use exemption from patent infringement liability by comparing the rationales behind promoting technological progress through granting exclusive patent rights in inventions with competing arguments for promoting scientific progress by allowing all investigators to enjoy free access to the discoveries of other scientists. I begin by reviewing key features of the patent laws and theoretical justifications for granting patent monopolies in order to clarify the implications of existing patent doctrine and theory for an experimental use exemption. I then look to the literature in the sociology, history, and philosophy of …
Academic Freedom And Academic Values In Sponsored Research, Rebecca S. Eisenberg
Academic Freedom And Academic Values In Sponsored Research, Rebecca S. Eisenberg
Articles
In this Article I examine the traditional American conception of academic freedom and analyze its implications for universities formulating policies on the acceptance of sponsored research. I begin by reviewing the basic policy statements of the American Association of University Professors (AAUP) on academic freedom to identify both the academic values implicit in those statements and the assumptions about institutional relationships and individual incentives underlying their prescriptions for advancing those values. I then evaluate the validity of those underlying assumptions in contemporary sponsored research and argue that academic freedom as traditionally conceived might no longer effectively advance academic values in …
Proprietary Rights And The Norms Of Science In Biotechnology Research, Rebecca S. Eisenberg
Proprietary Rights And The Norms Of Science In Biotechnology Research, Rebecca S. Eisenberg
Articles
As basic research in biotechnology yields increasing commercial applications, scientists and their research sponsors have become more eager to protect the commercial value of research discoveries through intellectual property law. Some scientists fear that these commercial incentives will weaken or even undermine the norms that have traditionally governed scientific research. In this Article, Professor Eisenberg examines the interaction of proprietary rights in inventions with these traditional scientific norms. Trade secrecy, she argues, is an undesirable strategy for protection of basic research discoveries because it impedes dissemination of new knowledge to the scientific community. She finds that patent law is in …