Science and Technology Law Commons^™

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is …

Testimony On Unmanned Aircraft Systems Rules And Regulations, Stephen E. Henderson

Stephen E Henderson

Bridging The Gap Between Intent And Status: A New Framework For Modern Parentage, Yehezkel Margalit

Hezi Margalit

The last few decades have witnessed dramatic changes in the conceptualization and methodologies of determining legal parentage in the U.S. and other countries in the western world. Through various sociological shifts, growing social openness and bio-medical innovations, the traditional definitions of family and parenthood have been dramatically transformed. This transformation has led to an acute and urgent need for legal and social frameworks to regulate the process of determining legal parentage. Moreover, instead of progressing in a piecemeal, ad-hoc manner, the framework for determining legal parentage should be comprehensive. Only a comprehensive solution will address the differing needs of today’s …

Spam Legislation In The United States, 22 J. Marshall J. Computer & Info. L. 3 (2003), David E. Sorkin

David E. Sorkin

This article examines the effect of spam legislation in the United States. It discusses state legislation and the common provisions of state spam legislation, such as disclosure and labeling requirements and opt-out provisions. It also analyzes the consequences of state anti-spam legislation. Federal legislation is analyzed, with a brief look at the CAN-SPAM Act of 2003. The article concludes that legislation has not had a big impact on spam, and the CAN-SPAM Act is not likely to change or curb spam.

Through The Lens Of Innovation, Mirit Eyal-Cohen

Mirit Eyal-Cohen

The legal system constantly follows the footsteps of innovation and attempts to discourage its migration overseas. Yet, present legal rules that inform and explain entrepreneurial circumstances lack a core understanding of the concept of innovation. By its nature, law imposes order. It provides rules, remedies, and classifications that direct behavior in a consistent manner. Innovation turns on the contrary. It entails making creative judgments about the unknown. It involves adapting to disarray. It thrives on deviations as opposed to traditional causation. This Article argues that these differences matter. It demonstrates that current laws lock entrepreneurs into inefficient legal routes. Using …

Cybersecurity: What About U.S. Policy?, Lawrence J. Trautman

Lawrence J. Trautman Sr.

During December 2014, just hours before the holiday recess, the U.S. Congress passed five major legislative proposals designed to enhance U.S. cybersecurity. Following signature by the President, these became the first cybersecurity laws to be enacted in over a decade, since passage of the Federal Information Security Management Act of 2002. My goal is to explore the unusually complex subject of cybersecurity policy in a highly readable manner. An analogy with the recent deadly and global Ebola epidemic is used to illustrate policy challenges, and hopefully will assist in transforming the technological language of cybersecurity into a more easily understandable …

The Safety For Human-Robot Co-Existing: On New Iso 13482 Safety Standard For Service Robots, Yueh-Hsuan Weng, Gurvinder Virk, Shuping Yang

Yueh-Hsuan Weng

On Patenting Human Organisms Or How The Abortion Wars Feed Into The Ownership Fallacy, Yaniv Heled

Yaniv Heled

The idea of ominous technologies that put human individuals or parts of their bodies under someone else's control has been stirring emotions and terrifying people for centuries. It was a recent offshoot of this idea--the notion of “patenting humans”--that mobilized certain members of Congress to pass legislation prohibiting the issuance of patent claims “directed to or encompassing a human organism.” The values underlying this legislation may well have been agreeable, even admirable. Yet, the actual motivation for it was misguided; its execution, deeply flawed; its potential outcomes, hazardous

This Article reviews the history and background of this prohibition. It fleshes …

Patents Vs. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both?, Yaniv Heled

Yaniv Heled

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products …

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Yaniv Heled

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …

Regulation Of Chemical Risks: Lessons For Tsca Reform From Canada And The European Union, Adam Abelkop, John D. Graham

Adam Abelkop

The United States Congress is considering reform of the Toxic Substances Control Act (TSCA) of 1976. This Article compares recent reforms in Europe and Canada in order to draw lessons for TSCA reform. In 2006, the European Union enacted the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation while Canada used existing authority under the Canadian Environmental Protection Act (CEPA) of 1999 to initiate the 2006 Chemicals Management Plan (CMP). Focusing on the tens of thousands of industrial chemicals now in use in the US, we offer several suggestions for TSCA reform based on the European and Canadian experiences. …

Protecting The Sender: Liability Protection For The Senders Of Electronic Communication, Meredith W. Doherty

Meredith W. Doherty

As the technology of smartphones has progressed, electronic communication has become an integral and portable part of our daily lives. A recent New Jersey case highlighted the issue of holding the sender of a text message liable for injuries resulting from a motor vehicle accident in which the driver at fault was reading a text message from the sender at the time of the accident. This note focuses on the implications of such liability being imposed on senders of text messages as well as the slippery slope that could result, taking all forms of electronic communication, social media and mobile …

The Evolution Of The Digital Millennium Copyright Act; Changing Interpretations Of The Dmca And Future Implications For Copyright Holders, Hillary A. Henderson

Hillary A Henderson

Copyright law rewards an artificial monopoly to individual authors for their creations. This reward is based on the belief that, by granting authors the exclusive right to reproduce their works, they receive an incentive and means to create, which in turn advances the welfare of the general public by “promoting the progress of science and useful arts.” Copyright protection subsists . . . in original works of authorship fixed in any tangible medium of expression, now known or later developed, from which they can be perceived, reproduced, or otherwise communicated, either directly or with the aid of a machine or …

No Surfing Allowed: A Review And Analysis Of Legislation Prohibiting Employers From Demanding Access To Employees’ And Job Applicants’ Social Media Accounts, Robert Sprague

Robert Sprague

This article examines recent state legislation prohibiting employers from requesting username and password information from employees and job applicants in order to access restricted portions of those employees’ and job applicants’ personal social media accounts. This article raises the issue of whether this legislation is even needed, from both practical and legal perspectives, focusing on: (a) how prevalent the practice is of requesting employees’ and job applicants’ social media access information; (b) whether alternative laws already exist which prohibit employers from requesting employees’ and job applicants’ social media access information; and (c) whether any benefits can be derived from this …

The Constitutional Infirmity Of Warrantless Nsa Surveillance: The Abuse Of Presidential Power And The Injury To The Fourth Amendment, Robert M. Bloom, William J. Dunn

Robert Bloom

In recent months, there have been many revelations about the tactics used by the Bush Administration to prosecute their war on terrorism. These stories involve the exploitation of technologies that allow the government, with the cooperation of phone companies and financial institutions, to access phone and financial records. This paper focuses on the revelation and widespread criticism of the Bush Administration’s operation of a warrantless electronic surveillance program to monitor international phone calls and emails that originate or terminate with a United States party. The powerful and secret National Security Agency heads the program and leverages its significant intelligence collection …

Taming A Dragon: Legislative History In Legal Analysis, Mark Deforrest

Mark DeForrest

ARTICLE ABSTRACT

TAMING A DRAGON:

LEGISLATIVE HISTORY IN LEGAL ANALYSIS

Mark DeForrest

The use of legislative history in statutory interpretation and analysis has been an area of intensive inquiry since the 1980’s. The debate has been vigorous and has led to the development of sophisticated arguments by both the advocates of the use of legislative history and textualists critical of its use. While the debate has been ongoing, changes in technology have made it easier than ever to access detailed legislative history for both state and federal statutes. This article discusses the impact of both the debate and the technological …

Surviving The America Invents Act’S Overhaul Of U.S. Patent Law - Startup And Small Business Perspectives, Ron D. Katznelson

Ron D. Katznelson

No abstract provided.

Policy Tailors And The Rookie Regulator, Sarah Tran

Sarah Tran

Commentators have long lamented the lack of policy tailoring in the patent system. But unlike other administrative agencies, who regularly tailor regulatory policies to the needs of specific industries, the U.S. Patent and Trademark Office (“PTO”) was widely believed to lack the authority and institutional competence for such policymaking. This Article provides the first comprehensive analysis of recent legislative reforms to the PTO’s policymaking authority. It shows the reforms empower the PTO to have a larger say in patent policy than ever before. The big question is thus: to what extent is it good policy for a rookie regulator to …

The America Invents Act May Be Constitutionally Infirm If It Repeals The Bar Against Patenting After Secret Commercial Use, Ron D. Katznelson

Ron D. Katznelson

No abstract provided.

La Transparencia En La Protección De Datos Personales, Bruno L. Costantini García

Bruno L. Costantini García

La Transparencia en la Protección de Datos Personales, ponencia elaborada dentro de los trabajos del VII Congreso Nacional de Organismos Públicos Autónomos (OPAM)

Aspectos Generales Dela Publicidad En México. "La Publicidad De Productos, Servicios, Y Actividades Reguladas Por La Ley General De Salud", Bruno L. Costantini García

Bruno L. Costantini García

Introducción a las generalidades de la regulación en materia de publicidad de insumos para el consumo humano (salud) en México.

Patent Reversion: An Employee-Inventor's Second Bite At The Apple, Richard Kamprath

Richard Kamprath

In an attempt to more fully compensate employee-inventors without harming the return on investment of employers, a patent reversion is proposed in which the rights to the patent revert to joint ownership between the original inventor and the current owner. In Section I, the background of the relationship between employer and employee-inventor will be discussed in terms of patent rights. This section will outline the problems inherent in the pre-assignment status quo of these rights from employees to employers. Section II will begin with Part A, which is a review of previously proposed solutions to the under-compensation of employee-inventors. The …

High Speed Rail In America: An Evaluation Of The Regulatory, Real Property, And Environmental Obstacles A Project Will Encounter, Darren A. Prum, Sarah L. Catz

Darren A. Prum

In 2009, President Barak Obama allocated $8 billion in stimulus funding for high speed rail projects across the United States. One year later, in 2010, an additional $2.5 billion was distributed to corridors with High Speed Rail Projects. Even though the most recent congressional budget eliminated high speed rail funding, many corridors are working diligently to break ground by the end of 2012. Before a high speed rail project can be fully implemented there are many legal and environmental issues and regulations to examine. This paper conducts a complete analysis of those issues and regulations and suggests how to apply …

Arctic Justice: Addressing Persistent Organic Pollutants, Prof. Elizabeth Burleson

Prof. Elizabeth Burleson

This article recommends enhanced governance of persistent organic pollutants through incentives to develop environmentally sound, climate friendly technologies as well as caution in developing the Arctic. It highlights the toxicity challenges presented by POPs to Arctic people and ecosystems.

Polar Law And Good Governance, Prof. Elizabeth Burleson

Prof. Elizabeth Burleson

This chapter will assess the Antarctic Treaty System, ask what polar lessons can be learned regarding common pool resources, and analyze law of the sea and related measures. It will consider such substantive areas as Arctic and Antarctic natural resource management and procedural opportunities as inclusive governance structures. Enhancing good governance can occur through trust building forums that bring together stakeholders, share information, and make environmentally sound decisions regarding sustainable development.

Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer

Parker Tresemer

Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is …

The Vehicle Miles Tax: The Unintended Consequences Of Paying As You Drive, Gregory A. Lush

Gregory A. Lush

No abstract provided.

The Vehicle Miles Tax: The Unintended Consequences Of Paying As You Drive, Gregory A. Lush

Gregory A. Lush

3. A Vehicle Miles Tax Reduces Manufacturer Incentives to Build Electric Vehicles

It follows that if consumers have few incentives to buy electric vehicles, manufacturers will have less of an incentive to make them. If electric cars were not in demand, then why would anyone make them and try to sell them? In a market that is finding electric vehicles to be a tough sell, we need to encourage the sale and production of electric vehicles as much as possible. The effect of enacting a mileage-based tax will be the attrition of automakers producing electric vehicles, furthering the nation’s dependency …

Noción Y Elementos Existenciales Del Título De Crédito, Bruno L. Costantini García

Bruno L. Costantini García

Discernir la noción y elementos de existencia de los títulos de crédito, considerando la doctrina y la denominación expresada en nuestra Ley General de Títulos y Operaciones de Crédito, conceptualizando el término de los documentos que consignan un derecho crediticio propio de su naturaleza y deslindando de manera dogmatica y exegética los elementos que lo forman y le dan su funcionamiento, mediante una visión de las instituciones jurídicas que les dan su existencia y aplicación dentro del devenir de los actos de comercio.

The Constitutional Infirmity Of Warrantless Nsa Surveillance: The Abuse Of Presidential Power And The Injury To The Fourth Amendment, Robert M. Bloom, William J. Dunn

Robert M. Bloom

In recent months, there have been many revelations about the tactics used by the Bush Administration to prosecute their war on terrorism. These stories involve the exploitation of technologies that allow the government, with the cooperation of phone companies and financial institutions, to access phone and financial records. This paper focuses on the revelation and widespread criticism of the Bush Administration’s operation of a warrantless electronic surveillance program to monitor international phone calls and emails that originate or terminate with a United States party. The powerful and secret National Security Agency heads the program and leverages its significant intelligence collection …