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Articles 1 - 23 of 23
Full-Text Articles in Law
Loopholes For Circumventing The Constitution: Unrestrained Bulk Surveillance On Americans By Collecting Network Traffic Abroad, Axel Arnbak, Sharon Goldberg
Loopholes For Circumventing The Constitution: Unrestrained Bulk Surveillance On Americans By Collecting Network Traffic Abroad, Axel Arnbak, Sharon Goldberg
Michigan Telecommunications & Technology Law Review
This Article reveals interdependent legal and technical loopholes that the US intelligence community could use to circumvent constitutional and statutory safeguards for Americans. These loopholes involve the collection of Internet traffic on foreign territory, and leave Americans as unprotected as foreigners by current United States (US) surveillance laws. This Article will also describe how modern Internet protocols can be manipulated to deliberately divert American’s traffic abroad, where traffic can then be collected under a more permissive legal regime (Executive Order 12333) that is overseen solely by the executive branch of the US government. Although the media has reported on some …
Instrument Choice, Carbon Emissions, And Information, Michael Wara
Instrument Choice, Carbon Emissions, And Information, Michael Wara
Michigan Journal of Environmental & Administrative Law
This Article examines the consequences of a previously unrecognized difference between pollutant cap-and-trade schemes and pollution taxes. Implementation of cap-and-trade relies on a forecast of future emissions, while implementation of a pollution tax does not. Realistic policy designs using either regulatory instrument almost always involve a phase-in over time to avoid economic disruption. Cap-and-trade accomplishes this phase-in via a limit on emissions that falls gradually below the forecast of future pollutant emissions. Emissions taxation accomplishes the same via a gradually increasing levy on pollution. Because of the administrative complexity of establishing an emissions trading market, cap-and-trade programs typically require between …
Can You Diagnose Me Now? A Proposal To Modify The Fda’S Regulation Of Smartphone Mobile Health Applications With A Pre-Market Notification And Application Database Program, Stephen Mcinerney
Can You Diagnose Me Now? A Proposal To Modify The Fda’S Regulation Of Smartphone Mobile Health Applications With A Pre-Market Notification And Application Database Program, Stephen Mcinerney
University of Michigan Journal of Law Reform
Advances in mobile technology continually create new possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the authority to regulate a broad spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if the FDA has the statutory authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, the FDA published Final Guidance on Mobile Medical Applications; in it, the Agency limited its oversight to …
District Courts Versus The Usitc: Considering Exclusionary Relief For F/Rand-Encumbered Standard-Essential Patents, Helen H. Ji
District Courts Versus The Usitc: Considering Exclusionary Relief For F/Rand-Encumbered Standard-Essential Patents, Helen H. Ji
Michigan Telecommunications & Technology Law Review
Technological standards allow manufacturers and consumers to rely upon these agreed-upon basic systems to facilitate sales and further invention. However, where these standards involved patented technology, the process of standard-setting raises many concerns at the intersection of antitrust and patent law. As patent holders advocate for their patents to become part of technological standards, how should courts police this activity to prevent patent holdup and other anti-competitive practices? This Note explores the differing approaches to remedies employed by the United States International Trade Commission and the United States District Courts where standard-essential patents are infringed. This Note further proposes that …
Wireless Localism: Beyond The Shroud Of Objectivity In Federal Spectrum Administration, Olivier Sylvain
Wireless Localism: Beyond The Shroud Of Objectivity In Federal Spectrum Administration, Olivier Sylvain
Michigan Telecommunications & Technology Law Review
Recent innovations in mobile wireless technology have instigated a debate between two camps of legal scholars about federal administration of the electromagnetic spectrum. The first camp argues that the Federal Communications Commission (“FCC”) should define spectrum use rights more clearly and give spectrum licensees broad property rights in frequencies. The second camp argues that, rather than award exclusive licenses to the highest bidder, the FCC ought to open much, if not most, of the spectrum to unlicensed use by smartphones and tablets equipped with the newest spectrum administration technology. First, this Article shows that both of these camps comprise a …
Adaptation And The Courtroom: Judging Climate Science, Kirsten Engel, Jonathan Overpeck
Adaptation And The Courtroom: Judging Climate Science, Kirsten Engel, Jonathan Overpeck
Michigan Journal of Environmental & Administrative Law
Climate science is increasingly showing up in courtroom disputes over the duty to adapt to climate change. While judges play a critical role in evaluating scientific evidence, they are not apt to be familiar with the basic methods of climate science nor with the role played by peer review, publication, and training of climate scientists. This Article is an attempt to educate the bench and the bar on the basics of the discipline of climate science, which we contend is a distinct scientific discipline. We propose a series of principles to guide a judge’s evaluation of the reliability and weight …
Making Method Visible: Improving The Quality Of Science-Based Regulation, Pasky Pascual, Wendy Wagner, Elizabeth Fisher
Making Method Visible: Improving The Quality Of Science-Based Regulation, Pasky Pascual, Wendy Wagner, Elizabeth Fisher
Michigan Journal of Environmental & Administrative Law
Scientific inferences are theories about how the world works that scientists formulate based on their observations. One of the most difficult issues at the intersection of law and science is to determine whether the weight of evidence supports one scientific inference versus other competing interpretations of the observations. In administrative law, this difficulty is exacerbated by the behavior of both the courts and regulatory agencies. Agencies seldom achieve the requisite visibility that explains the analytical methods they use to reach their scientific inferences. Courts—because they appreciate neither the variety of inferential methods nor their epistemic foundations—do not demand this level …
Rulemaking Vs. Democracy: Judging And Nudging Public Participation That Counts , Cynthia R. Farina, Mary Newhart, Josiah Heidt, Cornell Erulemaking Initiative
Rulemaking Vs. Democracy: Judging And Nudging Public Participation That Counts , Cynthia R. Farina, Mary Newhart, Josiah Heidt, Cornell Erulemaking Initiative
Michigan Journal of Environmental & Administrative Law
This Article considers how open government “magical thinking” around technology has infused efforts to increase public participation in rulemaking. We propose a framework for assessing the value of technology-enabled rulemaking participation and offer specific principles of participation-system design, which are based on conceptual work and practical experience in the Regulation Room project at Cornell University. An underlying assumption of open government enthusiasts is that more public participation will lead to better government policymaking: If we use technology to give people easier opportunities to participate in public policymaking, they will use these opportunities to participate effectively. However, experience thus far with …
Enhancing Public Access To Online Rulemaking Information, Cary Coglianese
Enhancing Public Access To Online Rulemaking Information, Cary Coglianese
Michigan Journal of Environmental & Administrative Law
One of the most significant powers exercised by federal agencies is their power to make rules. Given the importance of agency rulemaking, the process by which agencies develop rules has long been subject to procedural requirements aiming to advance democratic values of openness and public participation. With the advent of the digital age, government agencies have engaged in increasing efforts to make rulemaking information available online as well as to elicit public participation via electronic means of communication. How successful are these efforts? How might they be improved? In this article, I investigate agencies’ efforts to make rulemaking information available …
Foreword: Rulemaking, Democracy, And Torrents Of E-Mail, Nina A. Mendelson
Foreword: Rulemaking, Democracy, And Torrents Of E-Mail, Nina A. Mendelson
Articles
This Foreword is meant as an initial foray into the question of what agencies should do with mass public comments, particularly on broad questions of policy. Part I discusses the extent to which congressional control, presidential control, and agency procedures themselves can ensure that agency decisions are democratically responsive. In view of shortcomings in both congressional and presidential control, I underscore the need to focus closely on rulemaking procedures as a source of democratic responsiveness. The possibility that agencies may be systematically discounting certain public submissions raises difficulties, and I present some examples. Part II makes a preliminary case that …
Super Deference, The Science Obsession, And Judicial Review As Translation Of Agency Science, Emily Hammond Meazell
Super Deference, The Science Obsession, And Judicial Review As Translation Of Agency Science, Emily Hammond Meazell
Michigan Law Review
This Article explores what happens to longstanding remedies for past racial discrimination as conditions change. It shows that Congress and the Supreme Court have responded quite differently to changed conditions when they evaluate such remedies. Congress has generally opted to stay the course, while the Court has been more inclined to view change as cause to terminate a remedy. The Article argues that these very different responses share a defining flaw, namely, they treat existing remedies as fixed until they are terminated. As a result, remedies are either scrapped prematurely or left stagnant despite dramatically changed conditions. The Article seeks …
Nepa In The Hot Seat: A Proposal For An Office Of Environmental Analysis, Aliza M. Cohen
Nepa In The Hot Seat: A Proposal For An Office Of Environmental Analysis, Aliza M. Cohen
University of Michigan Journal of Law Reform
Judicial deference under the National Environmental Policy Act (NEPA) can be problematic. It is a well-established rule of administrative law that courts will grant a high degree of deference to agency decisions. They do this out of respect for agency expertise and policy judgment. This deference is applied to NEPA lawsuits without acknowledging the special pressures that agencies face while assessing the environmental impacts of their own projects. Though there is a strong argument that these pressures undermine the reasons for deferential review, neither the statute nor the courts have provided plaintiffs with adequate means to remedy this problem. Agency …
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
Articles
Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …
Obvious To Whom? Evaluating Inventions From The Perspective Of Phosita, Rebecca S. Eisenberg
Obvious To Whom? Evaluating Inventions From The Perspective Of Phosita, Rebecca S. Eisenberg
Articles
In this Article, I consider the possibility of giving the USPTO input from currently active technological practitioners in evaluating the obviousness of claimed inventions. Such input could potentially serve three useful functions. First, it could improve the accuracy of USPTO decisionmaking by providing access to the perspective of actual practitioners as to the obviousness of inventions from the perspective of the hypothetical PHOSITA. Second, it could help the USPTO document the evidentiary basis for rejections that rest in part upon tacit knowledge within technological communities. Third, it could provide a quality control mechanism that would improve the credibility of USPTO …
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Other Publications
It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …
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 …
Antitrust Enfocement And High-Technology Markets, William J. Baer, David A. Balto
Antitrust Enfocement And High-Technology Markets, William J. Baer, David A. Balto
Michigan Telecommunications & Technology Law Review
Although the antitrust laws apply to all industries, the application must be tempered in each case by the myriad ways in which competition can be modified by structural, behavioral, technological, regulatory, and other characteristics. The Commission applies the antitrust laws with sensitivity to the special characteristics of high-tech industries and of intellectual property, but also with the recognition that--as in other industries--competition plays an important role in spurring innovation and in spreading the benefits of that innovation to consumers. This focus is not new. This balanced approach has roots that go back at least to the 1977 Antitrust Guide to …
Public Research And Private Development: Patents And Technology Transfer In Government-Sponsored Research, Rebecca S. Eisenberg
Public Research And Private Development: Patents And Technology Transfer In Government-Sponsored Research, Rebecca S. Eisenberg
Articles
This article revisits the logical and empirical basis for current government patent policy in order to shed light on the competing interests at stake and to begin to assess how the system is operating in practice. Such an inquiry is justified in part by the significance of federally-sponsored research and development to the overall U.S. research effort. Although the share of national expenditures for research and development borne by the federal government has declined since 1980, federal funding in 1995 still accounted for approximately thirty-six percent of total national outlays for research and development' and nearly fifty-eight percent of outlays …
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 …
Federal Agency Treatment Of Uncertainty In Environmental Impact Statements Under The Ceq's Amended Nepa Regulation § 1502.22: Worst Case Analysis Or Risk Threshold, Charles F. Weiss
Michigan Law Review
This Note traces the judicial and administrative treatment of uncertainty under NEPA and supports the CEQ's replacement of worst case analysis with a qualitative probability threshold. Part I discusses the development of reasonableness standards in NEPA common law to define agency obligations prior to promulgation of the worst case analysis regulation. Part II reviews the worst case analysis regulation and its judicial construction. Finally, Part III outlines the amended regulation, which replaces worst case analysis with a probability threshold employing the rule of reason to limit EIS discussion to environmental effects shown through credible scientific evidence to be reasonably foreseeable. …
Federal Regulation Of Agricultural Biotechnologies, Thomas O. Mcgarity
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 …
Reciprocity In International Telecommunications Trade: A New Trade Barrier?, Sheryl Powers
Reciprocity In International Telecommunications Trade: A New Trade Barrier?, Sheryl Powers
Michigan Journal of International Law
To those advocating its use, reciprocity legislation is especially appropriate for the telecommunications industry. Only 5 percent of telecommunications equipment manufactured in the United States is exported for sale in other nations. Trade barriers, loyalty to domestic manufacturers and the importance of telecommunications to national defense systems have combined to restrict access to foreign markets in the telecommunications sector. To persuade other nations to increase market access in telecommunications, United States legislators added a requirement of reciprocity to two proposed bills, S.898 and H.R.5158. This note will examine these two bills, concluding that reciprocity is an inappropriate solution to United …