Open Access. Powered by Scholars. Published by Universities.®

Law Commons

Open Access. Powered by Scholars. Published by Universities.®

Articles 1 - 30 of 48

Full-Text Articles in Law

The Vaccine Race In The 21st Century, Ana Santos Rutschman Jan 2019

The Vaccine Race In The 21st Century, Ana Santos Rutschman

All Faculty Scholarship

In a world in which infectious diseases are spreading increasingly faster, the development of new human vaccines remains a priority in biopharmaceutical innovation. Legal scholars have addressed different aspects of vaccine regulation and administration, but less attention has been paid to the role of laws governing innovation during the stages of research and development (R&D) of vaccines.

This Article explores the race to develop new vaccines from its beginnings through the early 21st century, with a particular focus on the progressively pervasive role of intellectual property in governing vaccine innovation. It describes the insufficiencies of current innovation regimes in ...


Science As Speech, Natalie Ram Jan 2017

Science As Speech, Natalie Ram

All Faculty Scholarship

In April 2015, researchers in China reported the successful genetic editing of human embryos using a new technology that promised to make gene editing easier and more effective than ever before. In the United States, the announcement drew immediate calls to regulate or prohibit
outright any use of this technology to alter human embryos, even for purely research purposes. The fervent response to the Chinese announcement was, in one respect, unexceptional. Proposals to regulate or prohibit scientific research following a new breakthrough occur with substantial frequency. Innovations in cloning technology and embryonic stem cell research have prompted similar outcries, and ...


One Centimeter Over My Back Yard: Where Does Federal Preemption Of State Drone Regulation Start?, Henry H. Perritt Jr. Oct 2015

One Centimeter Over My Back Yard: Where Does Federal Preemption Of State Drone Regulation Start?, Henry H. Perritt Jr.

All Faculty Scholarship

The proliferation of cheap civilian drones and their obvious utility for precision agriculture, motion picture and television production, aerial surveying, newsgathering, utility infrastructure inspection, and disaster relief has accelerated the FAA’s sluggish effort to develop a proposal for generally applicable rules and caused it to grant more than 600 “section 333 exemptions” permitting commercial drone flight before its rules are finalized.

Federal preemption in the field of aviation safety regulation is generally assumed, but political pressure on states and municipalities to regulate drones and the ability of this revolutionary aviation technology to open up space close to the ground ...


Dna By The Entirety, Natalie Ram May 2015

Dna By The Entirety, Natalie Ram

All Faculty Scholarship

The law fails to accommodate the inconvenient fact that an individual’s identifiable genetic information is involuntarily and immutably shared with her close genetic relatives. Legal institutions have established that individuals have a cognizable interest in controlling genetic information that is identifying to them. The Supreme Court recognized in Maryland v. King that the Fourth Amendment is implicated when arrestees’ DNA is analyzed, and the Genetic Information Nondiscrimination Act protects individuals from genetic discrimination in the employment and health-insurance markets. But genetic information is not like other forms of private or personal information because it is shared — immutably and involuntarily ...


The Self, The Stasi, The Nsa: Privacy, Knowledge, And Complicity In The Surveillance State, Richard Warner, Robert H. Sloan Jan 2015

The Self, The Stasi, The Nsa: Privacy, Knowledge, And Complicity In The Surveillance State, Richard Warner, Robert H. Sloan

All Faculty Scholarship

We focus on privacy in public. The notion dates back over a century, at least to the work of the German sociologist, Georg Simmel. Simmel observed that people voluntarily limit their knowledge of each other as they interact in a wide variety of social and commercial roles, thereby making certain information private relative to the interaction even if it is otherwise publicly available. Current governmental surveillance in the US (and elsewhere) reduces privacy in public. But to what extent?

The question matters because adequate self-realization requires adequate privacy in public. That in turn depends on informational norms, social norms that ...


Sharing Public Safety Helicopters, Henry H. Perritt Jr. Apr 2014

Sharing Public Safety Helicopters, Henry H. Perritt Jr.

All Faculty Scholarship

No abstract provided.


Drones, Henry H. Perritt Jr., Eliot O. Sprague Apr 2014

Drones, Henry H. Perritt Jr., Eliot O. Sprague

All Faculty Scholarship

Abstract

Drone technology is evolving rapidly. Microdrones—what the FAA calls “sUAS”—already on the market at the $1,000 level, have the capability to supplement manned helicopters in support of public safety operations, news reporting, and powerline and pipeline patrol, when manned helicopter support is infeasible, untimely, or unsafe.

Larger drones–"machodrones”–are not yet available outside battlefield and counterterrorism spaces. Approximating the size of manned helicopters, but without pilots, or with human pilots being optional, their design is still in its infancy as designers await greater clarity in the regulatory requirements that will drive airworthiness certification.

This article ...


Response To "Pervasive Sequence Patents Cover The Entire Human Genome", Shine Tu, Christopher M. Holman, Adam Mossoff, Ted M. Sichelman, Michael Risch, Jorge L. Contreras, Yaniv Heled, Gregory Dolin, Lee Petherbridge Jan 2014

Response To "Pervasive Sequence Patents Cover The Entire Human Genome", Shine Tu, Christopher M. Holman, Adam Mossoff, Ted M. Sichelman, Michael Risch, Jorge L. Contreras, Yaniv Heled, Gregory Dolin, Lee Petherbridge

All Faculty Scholarship

In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of a patent – in the patents they analyzed. Specifically, the authors do not provide an adequate basis for their assertion that 41% of the genes in the human genome have been claimed.


Speaking Of Science: Introducing Notice And Comment Into The Legislative Process, Gregory Dolin Jan 2014

Speaking Of Science: Introducing Notice And Comment Into The Legislative Process, Gregory Dolin

All Faculty Scholarship

Congress enacts, on a nearly continuous basis, a variety of laws that affect scientific research and progress. Some of these laws have an unquestionably positive effect. For instance, Congress's creation of the National Institutes of Health, the National Academy of Sciences, and NASA; its various appropriations to fund ground-breaking research; and a multitude of other laws have incalculably advanced human knowledge, and it is to Congress's great credit that these laws have been and are continuing to be enacted. However, not all laws that affect the progress of sciences are an unalloyed good. Quite the opposite, often the ...


Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin May 2013

Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin

All Faculty Scholarship

Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists' ability to continue and expand research into the human genome to improve patients' access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court, which is considering a petition for certiorari in Ass'n for Molecular Pathology v ...


Beyond Notice And Choice: Privacy, Norms, And Consent, Richard Warner, Robert Sloan Jan 2013

Beyond Notice And Choice: Privacy, Norms, And Consent, Richard Warner, Robert Sloan

All Faculty Scholarship

Informational privacy is the ability to determine for yourself when and how others may collect and use your information. Adequate informational privacy requires a sufficiently broad ability to give or withhold free and informed consent to proposed uses.

Notice and Choice (sometimes also called “notice and consent”) is the current paradigm for consent online. The Notice is a presentation of terms, typically in a privacy policy or terms of use agreement. The Choice is an action signifying acceptance of the terms, typically clicking on an “I agree” button, or simply using the website. Recent reports by the Federal Trade Commission ...


Behavioral Advertising: From One-Sided Chicken To Informational Norms, Richard Warner, Robert Sloan Jan 2012

Behavioral Advertising: From One-Sided Chicken To Informational Norms, Richard Warner, Robert Sloan

All Faculty Scholarship

When you download the free audio recording software from Audacity, you agree that Audacity may collect your information and use it to send you advertising. Billions of such pay-with-data exchanges feed information daily to a massive advertising ecosystem that tailors web site advertising as closely as possible to individual interests. The vast majority want considerably more control over our information. We nonetheless routinely enter pay-with-data exchanges when we visit CNN.com, use Gmail, or visit any of a vast number of other websites. Why? And, what, if anything, should we do about it? We answer both questions by describing pay-with-data ...


Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch Jan 2012

Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch

All Faculty Scholarship

Pharmacogenomics, the study and development of compounds according to how an individual’s genes affects the body’s response to drugs, holds enormous promise for increasing the safety and efficiency of drug development while decreasing adverse reactions and the trial-and-error nature of drug prescription. However, pharmacogenomics may not be the panacea for all development and prescription problems. This article explores some of the obstacles to pharmacogenomic advancement including industry reluctance to pursue research because of potentially prohibitive costs associated with developing products and legal liability concerns. The implications pharmacogenomics has for drug research and development as well as various areas ...


Digital Originality, Edward Lee Jan 2012

Digital Originality, Edward Lee

All Faculty Scholarship

This Article examines the doctrine of originality in U.S. copyright law and proposes a reconfigured, three-part test that can better analyze issues of first impression involving works created with new digital technologies. The proposed test, encapsulated by the concept of digital originality, provides much needed guidance to courts to address the increasing complexities of digital creations in the twenty-first century.


Pgtandme: Social Networking-Based Genetic Testing And The Evolving Research Model, Valerie Gutmann Koch Jan 2012

Pgtandme: Social Networking-Based Genetic Testing And The Evolving Research Model, Valerie Gutmann Koch

All Faculty Scholarship

The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling its direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and – highlighting the challenges associated with a new paradigm of “patient-driven” genomic research – focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article also explores ...


Fortuity And Forensic Familial Identification, Natalie Ram Apr 2011

Fortuity And Forensic Familial Identification, Natalie Ram

All Faculty Scholarship

On July 7, 2010, Los Angeles police announced the arrest of a suspect in the Grim Sleeper murders, so called because of a decade-long hiatus in killings. The break in the case came when California searched its state DNA database for a genetic profile similar, but not identical, to the killer’s. DNA is inherited in specific and predictable ways, so a source-excluding partial match might indicate that a close genetic relative of the matching offender was the Grim Sleeper. California’s apparent success in this case has intensified interest in policymaking for source-excluding partial matching. To date, however, little ...


Copyright, Death, And Taxes, Edward Lee Jan 2011

Copyright, Death, And Taxes, Edward Lee

All Faculty Scholarship

The Copyright Act of 1976 is due for a major revision in the 21st century, in order to keep pace with the advances in digital technologies. This Article offers a new alternative for copyright reform: tax law. Using the tax system as a way to modernize our copyright system offers several advantages. Most important, tax law can fix problems in our copyright system without violating the Berne Convention or TRIPS Agreement, and without requiring amendment to either treaty. Tax law can also be used to incentivize the copyright industries to adopt new, innovative approaches to copyright in ways that voluntary ...


Cyberclinics: Law Schools, Technology And Justice, Ronald W. Staudt Jan 2011

Cyberclinics: Law Schools, Technology And Justice, Ronald W. Staudt

All Faculty Scholarship

No abstract provided.


Undermined Norms: The Corrosive Effect Of Information Processing Technology On Informational Privacy, Richard Warner Mar 2010

Undermined Norms: The Corrosive Effect Of Information Processing Technology On Informational Privacy, Richard Warner

All Faculty Scholarship

Informational privacy is a matter of control; it consists in the ability to control when one’s personal information is collected, how it is used, and to whom it is distributed. The degree of control we once enjoyed has vanished. Advances in information processing technology now give others considerable power to determine when personal information is collected, how it is used, and to it is whom distributed. Privacy advocates sound the alarm in regard to both the governmental and private sectors. I focus exclusively on the later. Relying on the extensive privacy advocate literature, I assume we should try to ...


White Paper, The Emergence Of Knowledge Analysis: Change And Knowledge Management In Large Law Firms, Ronald W. Staudt Jan 2010

White Paper, The Emergence Of Knowledge Analysis: Change And Knowledge Management In Large Law Firms, Ronald W. Staudt

All Faculty Scholarship

No abstract provided.


Technological Fair Use, Edward Lee Jan 2010

Technological Fair Use, Edward Lee

All Faculty Scholarship

The Article proposes a framework tailoring fair use specifically for technology cases. At the inception of the twenty-first century, information technologies have become increasingly central to the U.S. economy. Not surprisingly, complex copyright cases involving speech technologies, such as DVRs, mp3 devices, Google Book Search, and YouTube, have increased as well. Yet existing copyright law, developed long before digital technologies, is ill-prepared to handle the complexities these technology cases pose. The key question often turns, not on prima facie infringement, but on the defense of fair use, which courts have too often relegated to extremely fact-specific decisions. The downside ...


Significant Statistics: The Unwitting Policy Making Of Mathematically Ignorant Judges, Michael I. Meyerson, William Meyerson Jan 2010

Significant Statistics: The Unwitting Policy Making Of Mathematically Ignorant Judges, Michael I. Meyerson, William Meyerson

All Faculty Scholarship

This article will explore several areas in which judges, hampered by their mathematical ignorance, have permitted numerical analysis to subvert the goals of our legal system. In Part II, I will examine the perversion of the presumption of innocence in paternity cases, where courts make the counter-factual assumption that regardless of the evidence, prior to DNA testing, a suspect has a 50/50 chance of being the father. In Part III, I will explore the unnecessary injection of race into trials involving the statistics of DNA matching, even when race is entirely irrelevant to the particular case. Next, in Part ...


The Time And Place For "Technology-Shifting" Rights, Max Oppenheimer Jan 2010

The Time And Place For "Technology-Shifting" Rights, Max Oppenheimer

All Faculty Scholarship

Intellectual property policy requires balance between the goal of motivating innovation and the need to prevent that motivation from stifling further innovation. The constitutional grant of congressional power to motivate innovation by securing "for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries" is qualified by the requirement that congressional enactments under the Intellectual Property Clause "promote progress."

The speed of technological change, particularly in the converging fields of computer software, music, video, television, and communications, coupled with the power of technology industry lobbying, have left the statutory balance tilted in favor of rewarding ...


A Defense Of Embryonic Stem Cell Research, Gregory Dolin Oct 2009

A Defense Of Embryonic Stem Cell Research, Gregory Dolin

All Faculty Scholarship

On November 21, 2007, sensational scientific developments were reported by major newspapers, both in the United States and abroad. The media reported a new breakthrough in the area of stem cell research. According to two articles published in Science and Cell (both highly respected scientific journals), two teams of scientists were able to “reprogram” adult stem cells into embryonic stem cells, without actually having to experiment on embryos. The discovery was immediately hailed by the White House and other opponents of embryonic stem cell research. The New York Times gushed that the “stem cell wars” may be at an end ...


All The Wild Possibilities: Technology That Attacks Barriers To Access To Justice, Ronald W. Staudt Jul 2009

All The Wild Possibilities: Technology That Attacks Barriers To Access To Justice, Ronald W. Staudt

All Faculty Scholarship

Predicting how technology will affect the future of the legal profession is difficult and unreliable work. I have made my share of such predictions in the past thirty years, including foretelling the death of the paper casebook in law schools and vast improvements in law practice that would be triggered by computers and document assembly software. Neither of these two prophesies has yet been fulfilled. Yet a real success story has emerged based in part on my persistent optimism that technology can improve the delivery of legal services. A2J Author, a modest software tool that allows lawyers to build guided ...


Conflicts Of Interest In Clinical Trial Recruitment & Enrollment: A Call For Increased Oversight, Valerie Gutmann Koch Jan 2009

Conflicts Of Interest In Clinical Trial Recruitment & Enrollment: A Call For Increased Oversight, Valerie Gutmann Koch

All Faculty Scholarship

This White Paper makes several policy recommendations to eliminate or manage the conflicts of interest that arise pursuant to the compensation arrangements between investigators and their institutions with drug and medical device manufacturers as they affect the recruitment and enrollment of human research subjects in clinical trials. The paper seeks to accomplish overall financial neutrality as between treatment and research, so that physicians' decisions regarding inclusion of patients in clinical trials is unaffected by their own financial interests.


Decoding The Dmca Safe Harbors, Edward Lee Jan 2009

Decoding The Dmca Safe Harbors, Edward Lee

All Faculty Scholarship

The DMCA is a decade old, which, in Internet time, may well be closer to a century. Although the DMCA safe harbors have helped to foster tremendous growth in web applications in our Web 2.0 world, several very basic aspects of the DMCA safe harbors remain uncertain. These uncertainties, along with the relative lack of litigation over the DMCA in the past ten years, have threatened to undermine the whole purpose of the DMCA safe harbors by failing to inform the public and technology companies of what steps they need to undertake to fall within the safe harbors. In ...


Tales From The Crypt: Scientific, Ethical, And Legal Considerations For Biohistorical Analysis Of Deceased Historical Figures, Lori B. Andrews, Jordan K. Paradise Jan 2008

Tales From The Crypt: Scientific, Ethical, And Legal Considerations For Biohistorical Analysis Of Deceased Historical Figures, Lori B. Andrews, Jordan K. Paradise

All Faculty Scholarship

Biohistorical analysis involves using historic specimens of human remains or human material extracted or derived from historical artifacts to gather evidence about specimens that are identifiable or at least attributed to a historic figure at the time of the research. Biohistorical studies are being undertaken for myriad reasons, such as identification and authentication of remains, investigation into alleged criminal behavior, investigation into medical or psychological conditions, and even for purposes of commercialization. This article analyzes federal statutes, case law, and codes and guidelines from twenty-six professional organizations and societies informative to the field of biohistory. We surveyed the field, identified ...


Turned On Its Head?: Norms, Freedom, And Acceptable Terms In Internet Contracting, Richard Warner Jan 2008

Turned On Its Head?: Norms, Freedom, And Acceptable Terms In Internet Contracting, Richard Warner

All Faculty Scholarship

Is the Internet turning contract law on its head? Many commentators contend it is. Precisely this issue arises in current controversies over end user license agreements (EULAs) and Terms of Use agreements (TOUs, the agreements governing our use of web sites). Commentators complain that, in both cases, the formation process unduly restricts buyers’ freedom; and, that sellers and web site owners exploit the process to impose terms that deprive consumers of important intellectual property and privacy rights. The courts ignore the criticisms and routinely enforce EULAs and TOUs. There is truth on both sides of this court/commentator divide. EULAs ...


The "Reasonable Plant" Test: When Progress Outruns The Constitution, Max Oppenheimer Jan 2008

The "Reasonable Plant" Test: When Progress Outruns The Constitution, Max Oppenheimer

All Faculty Scholarship

No abstract provided.