Law Commons^™

Beyond Rights And Welfare: Democracy, Dialogue, And The Animal Welfare Act, Jessica Eisen

University of Michigan Journal of Law Reform

The primary frameworks through which scholars have conceptualized legal protections for animals—animal “rights” and animal “welfare”—do not account for socio-legal transformation or democratic dialogue as central dynamics of animal law. The animal “rights” approach focuses on the need for limits or boundaries preventing animal use, while the animal “welfare” approach advocates balancing harm to animals against human benefits from animal use. Both approaches rely on abstract accounts of the characteristics animals are thought to share with humans and the legal protections they are owed as a result of those traits. Neither offers sustained attention to the dynamics of legal change …

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 …

After Myriad: Reconsidering The Incentives For Innovation In The Biotech Industry, Daniel K. Yarbrough

Michigan Telecommunications & Technology Law Review

35 U.S.C. § 101 allows a patent for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Recently, the Supreme Court issued several key decisions affecting the doctrine of patentable subject matter under § 101. Starting with Bilski v. Kappos (2011), and continuing with Mayo Collaborative Services, Inc. v. Prometheus Laboratories (2012), Association for Molecular Pathology v. Myriad Genetics (2013) and, most recently, Alice Corporation Pty. Ltd. v. CLS Bank International (2014), every year has brought another major change to the way in which the Court assesses patentability. In Myriad, the …

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 …

The Universal Declaration On Bioethics And Human Rights: Promoting International Discussion On The Morality Of Non-Therapeutic Research On Children, Anna Gercas

Michigan Journal of International Law

After describing the Declaration and its drafting history, this Note will summarize several international, national, and regional guidelines regarding children as research subjects. The Note then argues for a prohibition of non-therapeutic research on children and concludes that international human rights law offers the most appropriate basis for the development of regulations on human experimentation.

Reaching Through The Genome, Rebecca S. Eisenberg

Book Chapters

The past two decades have been a period of rapid evolution in the science of biotechnology and therefore in patent strategies, if not in patent law itself. Patent law takes a long time to catch up with science, and commentators take a long time to catch up with the law, but patent lawyers don’t have that luxury. They have to keep ahead of the game, figuring out claiming strategies that allow their clients to capture the value of future discoveries. I want to discuss some of these strategies today.

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

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

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

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

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 …

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, …

U.S. Government Control Over The Export Of Scientific Research And Other Technical Data: Holes In The Sieve, Robert Greenspoon

Michigan Journal of International Law

In Part I, I establish the backdrop for answering the question by describing the kinds of scientific data that might be subject to security classification and export licensing. In Part II, I outline briefly who chooses what should be restricted and who enforces these restrictions. In Part III, I describe several situations in which the federal government has vigorously enforced controls over the dissemination of scientific information. I also analyze two recent cases involving computer software that I believe analogize directly to the scientific endeavor. Finally, in Part IV, I explain why First Amendment barriers, the growth of the Internet …

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 …

Criminal Liability For Misconduct In Scientific Research, Susan M. Kuzma

University of Michigan Journal of Law Reform

This Article will explore our society's attitude to prosecuting scientific misconduct, the need to consider prosecution in such cases, and the utility of current statutes available for prosecution. To assist the reader in understanding the issues, this Article will provide some background information about misconduct in scientific research and will include a discussion of some specific incidents. These background materials provide a context for my argument that criminal sanctions should be available to punish scientific misconduct. Finally, I propose a federal criminal statute designed specifically for prosecuting scientific misconduct.

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

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

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

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 …

Federal Biotechnology Policy: The Perils Of Progress And The Risks Of Uncertainty, Al Gore

University of Michigan Journal of Law Reform

Americans have a schizophrenic view of science and technology. Some of our greatest heroes have been technological pioneers- from the Wright brothers to Lindbergh to Chuck Yeager. Until recently, we expressed unmitigated adoration for the scientists and engineers who put man in space. Yet at the same time, many Americans are generally uneasy about the triumph of technology in their own lives. One does not have to be a Luddite to rail against computers every now and then.

In deciding how to allocate precious public resources in an era of limits, legislators must take public perceptions of science very seriously. …

Introduction: Legislative, Administrative, And Judicial Nonscience, Samuel D. Estep

University of Michigan Journal of Law Reform

This symposium deals with the legal issues, or rather some of them, that are created by scientific research. Anyone remotely interested in scientific developments should be aware that even the existence of "new" scientific "facts," let alone the application of such discoveries to everyday activities, gives rise to a host of human value judgments that should be faced and resolved by society. Although these problems are often left in purgatory forever, it is the legal system, broadly defined, that attempts to resolve the conflict of interests (or the balancing of values) when a decision is made. Making this type of …

Scientific Responsibility And The Law, Harold P. Green

University of Michigan Journal of Law Reform

Because public policy is implicated by scientific misconduct, the legal profession should be interested in overcoming this problem. This Article studies the scientific misconduct problem and provides a personal view of the legal dilemmas that confront those who report misconduct. Part I describes how the scientific community currently deals with alleged fraud. Scientists primarily rely on the peer review system and toothless guidelines. Part II illustrates the problems in the present system through a case study of an allegation of misconduct. The author represented a man who reported scientific misconduct; the National Institutes of Health (NIH) investigation took five and …

Earmarked Appropriations: The Debate Over The Method Of Federal Funding, Donald N. Langenberg

University of Michigan Journal of Law Reform

The report that follows is the product of the Committee's deliberations.

The associations which sponsored the Committee and to which its report was addressed are at this date still considering the recommendations of the report. The Association of American Universities has adopted a resolution reaffirming its position supporting the use of scientific merit for research funding decisions and opposing earmarked funding, and agreeing to a moratorium on earmarked funding while the Association supports the creation of federally-funded research facilities programs. The American Association of State Colleges and Universities and the National Association of Independent Colleges and Universities have adopted or …

On The Human Body As Property: The Meaning Of Embodiment, Markets, And The Meaning Of Strangers, Thomas H. Murray

University of Michigan Journal of Law Reform

For as long as I can recall, newspapers have published brief items in which someone has calculated what the human body is "worth" on the open market. The value of the body-as reduced to its chemical components-was never more than a few dollars. A more accurate accounting, though, would include the market value of transplantable organs and tissues, as well as the potential bonanza to be had should a cell line cultured from that body prove valuable to the biotechnology industry. The bottom line could be anywhere from tens of thousands to perhaps millions of dollars.

Both moral and legal …

Federal Regulation Of Agricultural Biotechnologies, Thomas O. Mcgarity

University of Michigan Journal of Law Reform

Part I of this Article describes some of the risks and benefits of newly emerging agricultural biotechnologies. After discussing, in Part II, the role of federal agencies in regulating agricultural biotechnologies, Part III of the Article proposes elements for an adequate regulatory regime. Part IV then measures the existing legal authorities, as implemented by the USDA and the EPA, against the ideal elements. Part V examines the willingness of these agencies to regulate. Finally, Part VI suggests changes that can be made in the current regulatory regime to bring about more effective regulation and to enhance public trust in regulatory …

Cloning And The Constitution: An Inquiry Into Governmental Policymaking And Genetic Experimentation, Barry J. Swanson

Michigan Law Review

A Review of Cloning And the Constitution: An Inquiry Into Governmental Policymaking and Genetic Experimentation by Ira H. Carmen

The Juridical Status Of The Fetus: A Proposal For Legal Protection Of The Unborn, Patricia A. King

Michigan Law Review

What claims to protection can be asserted by a human fetus? That question, familiar to philosophy and religion, has long haunted law as well. While the philosophical and theological issues remain unresolved, and are perhaps unresolvable, I believe that we can no longer avoid some resolution of the legal status of the fetus. The potential benefits of fetal research, the ability to fertilize the human ovum in a laboratory dish, and the increasing awareness that a mother's activities during pregnancy may affect the health of her offspring create pressing policy issues that raise possible conflicts among fetuses, mothers, and researchers. …