Law Commons^™

Application Of The Ada To Websites: Congress Should Rely On The Standards Created By The World Wide Consortium, Mara'd A. Smith

Mara'D Smith

Congress created the Americans with Disabilities Act (ADA) in 1990 to assure equality of opportunity and independent living to those with physical or mental abilities. Although the roots of the Internet were growing rapidly when Congress passed the ADA, the World Wide Web did not become popular until the mid 1990s. Congress has not yet updated the ADA to clearly cover websites, and the current regulations that ensure access for disabled persons to physical locations do not clearly apply to websites. This paper argues that Congress should rely on the World Wide Web Consortium standards when revising the ADA to …

Building Bio-Based Supply Chains: Theoretical Perspectives On Innovative Contract Design, A. Bryan Endres, Jody M. Endres, Jeremy J. Stoller

A. Bryan Endres

By 2030, the United States will consume over 300 million tons of forest and agricultural feedstocks for energy production. The supply chain necessary to provide unprecedented quantities of new “bioenergy crops,” however, is fraught with uncertainty. The vertically integrated model the nascent sector currently uses may have limited opportunity for expansion to meet renewable energy mandates. A hybrid structure is likely to emerge as the industry evolves, in which end-users closely cooperate with a large number of heterogeneous producers through long-term contracting rather than as direct owners or operators of biomass farms. This “vertically coordinated” industry model is dependent on …

Evading Emergency: Strengthening Emergency Response Through Integrated Pluralistic Governance, Lance Gable

Lance Gable

This Article examines the significant governance challenges that arise during responses to public health emergencies and proposes a new multifaceted strategy—integrated pluralistic governance—to address these challenges. Emergency preparedness is an inherently complex problem that entails the integration of scientific and medical expertise, good logistical planning, and clear laws and policies. The governance function has particular import for public health emergencies because pandemics, hurricanes, and other disasters can have profoundly divisive social and political consequences. Moreover, recent disasters like Hurricane Katrina and the BP Deepwater Horizon Oil Spill revealed an emergency preparedness and response infrastructure in the United States that was …

Patenting Isolated Human Enhancer Elements And The Utility Requirement Problem, William B. Mcconnell

William B. McConnell

No abstract provided.

Mistake-Proofing Medicine: Legal Considerations And Healthcare Quality Implications, Arlen W. Langvardt

Arlen W Langvardt

MISTAKE-PROOFING MEDICINE: LEGAL CONSIDERATIONS

AND HEALTHCARE QUALITY IMPLICATIONS

Authors: John R. Grout, John W. Hill, Arlen W. Langvardt (corresponding author).

Abstract

In 1999, the Institute of Medicine estimated that approximately 98,000 deaths resulted annually from medical errors. This shocking number does not appear to have lessened during the intervening years. Although mistake-proofing techniques similar to those that have proven useful in the product liability context hold great promise for reducing the number of medical errors, the adoption of such techniques in healthcare settings has not occurred to the extent it should have.

This article examines potentially useful mistake-proofing techniques, explores …

It's About Time: Privacy, Information Life Cycles, And The Right To Be Forgotten, Meg Leta Ambrose

Meg Leta Ambrose

The current consensus is that information, once online, is there forever. Content permanence has led many European countries, the European Union, and even the United States to establish a right to be forgotten to protect citizens from the shackles of the past presented by the Internet. But, the Internet has not defeated time, and information, like everything, gets old, decays, and dies, even online. Quite the opposite of permanent, the Web cannot be self-preserving. One study from the field of content persistence, a body of research that has been almost wholly overlooked by legal scholars, found that 85% of content …

Search, Essential Facilities, And The Antitrust Duty To Deal, Marina Lao

Marina Lao

The core of the gathering antitrust case against Google seems to be that it favors its own or its affiliates’ content over that of its competitors in ancillary markets in the unpaid search results. Seeking the competitive advantages inherent in integration, which is what preferential treatment of one’s own property is about, is usually not unlawful. This paper examines whether “essential facilities” and the duty-to-deal nonetheless provide a basis for prohibiting this practice, as some have suggested, and concludes that they do not.

On the threshold monopoly power issue, most assume, based on Google’s high percentage of general search queries, …

The Flaws Of Stem Cell Legislation: Sherley, Brustle, And Future Policy Challenges Posed By Induced Pluripotent Stem Cells, Nicholas J. Diamond

Nicholas J Diamond

In this article, I first contextualize the origins of disagreement over the nature and extent of human embryonic stem cell (hESC) research regulation. By analyzing two key pieces of hESC legislation as considered in two landmark court decisions—one from the United States and one from the European Union—I argue that current stem cell policies are deeply flawed. After surfacing the flaws of these policies, I examine novel challenges for policymakers posed by the newest advancement in stem cell science, induced pluripotent stem cells. In view of these novel challenges, I contend that current policies, which are hESC-focused and deeply flawed, …

Employee And Inventor Witnesses In Patent Trials: The Blurry Line Between Expert And Lay Testimony, Alex Reese

Alex Reese

Parties in patent lawsuits that are going to trial face a crucial choice: who is the best witness to explain the often complex or scientific technology behind an invention or an accused product? Often, the parties will select an employee witness such as an engineer, scientist, or a named inventor of the patent-in-suit to offer this key testimony rather than a hired expert. Many litigants have found that there are benefits to choosing an employee witness who can testify based on first-hand experience with the technology in question rather than a hired expert, who must prepare an expert report and …

Patent Infringement In The Context Of Follow-On Biologics, Janet Freilich

Janet Freilich

This article fills a gap in the literature by conducting a comprehensive analysis of patent infringement in the context of follow-on biologics. Patent infringement is an important topic because, like small molecule generic drugs, follow-on biologics are likely to begin their life facing infringement suits. Because it is tremendously expensive to develop a follow-on biologic, it is vital that there be consistency in how they are treated in the courts once the inevitable patent infringement suits arrive. If follow-on biologics companies cannot predict how their product will be received in court, they may decide it is not worth the risk …

The Paradox Of Legal Equivalents And Scientific Equivalence: Reconciling Patent Law’S Doctrine Of Equivalents With The Fda’S Bioequivalence Requirement, Janet Freilich

Janet Freilich

Contrary to popular perception, generic drugs often enter the market before the patents covering their brand-name counterparts have expired by making slight changes the drug to avoid the brand-name patent. These generics face a paradox: the FDA requires that the generic “not show a significant difference” from the reference product while patent law requires that the generic have “substantial differences” as compared to the reference product. The generic must be bioequivalent but not legally equivalent to the brand-name drug. This paradox occurs frequently in the courts but has never been discussed in the literature. This article analyzes every case involving …

Rationalizing Risks To Cultural Loss In Resource Development, Sari M. Graben

Sari M Graben

Abstract In this article, I consider the implications of culture for valuation of cultural loss in cost benefit analysis. I argue that rational choice models have a difficult time quantifying cultural values because they have yet to grapple with the way experts tasked with cost benefit analysis translate knowledge about cultural worldviews for the purposes of comparison. This translation can alter the valuation of the risk so as to undermine the representation of a loss, rather than identify it. However, instead of rejecting the consideration of cultural loss in cost-benefit analysis outright, I build on dialogical approaches to governance that …

Search, Essential Facilities, And The Antitrust Duty To Deal, Marina Lao

Marina Lao

The core of the gathering antitrust case against Google seems to be that it favors its own or its affiliates’ content over that of its competitors in ancillary markets in the unpaid search results. Seeking the competitive advantages inherent in integration, which is what preferential treatment of one’s own property is about, is usually not unlawful. This paper examines whether “essential facilities” and the duty-to-deal nonetheless provide a basis for prohibiting this practice, as some have suggested, and concludes that they do not.

On the threshold monopoly power issue, most assume, based on Google’s high percentage of general search queries, …

Search, Essential Facilities, And The Antitrust Duty To Deal, Marina Lao

Marina Lao

The core of the gathering antitrust case against Google seems to be that it favors its own or its affiliates’ content over that of its competitors in ancillary markets in the unpaid search results. Seeking the competitive advantages inherent in integration, which is what preferential treatment of one’s own property is about, is usually not unlawful. This paper examines whether “essential facilities” and the duty-to-deal nonetheless provide a basis for prohibiting this practice, as some have suggested, and concludes that they do not.

On the threshold monopoly power issue, most assume, based on Google’s high percentage of general search queries, …

A Dangerous Distinction: The Deconstitutionalization Of Private Speech, Derigan Silver, Ruth Walden

Derigan Silver

In the mid-1960s the U.S. Supreme Court began applying a Meiklejohnian approach to certain First Amendment claims, using a self-government rationale to justify enhanced protection for freedom of expression on matters of public concern in cases involving defamation, false light invasion of privacy, government employees’ speech, and intentional infliction of emotional distress, as well as others. The Court, however, refrained from acknowledging the remainder of Meiklejohn’s argument — that private speech is outside the purview of the First Amendment and protected only by the Due Process Clause of the Fifth Amendment. In the wake of Supreme Court defamation rulings in …

Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq

Vincent J Roth Esq

Much controversy has ensued over the current 12 year data exclusivity period afforded biosimilars pursuant to the Biologics Price Competition and Innovation Act of 2009 (the “BPCI”) that was recently enacted in March 2010, as part of President Obama’s Patient Protection and Affordable Care Act (the “PPACA”), to create a biosimilar market in the US. In fact, the BPCI, itself, has been controversial and just barely survived judicial scrutiny when the US Supreme Court upheld the PPACA on June 28, 2012 in a 5-4 vote. Many commentators speculate whether data exclusivity will overtake patents as the preferred method of intellectual …

Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq

Vincent J Roth Esq

Much controversy has ensued over the current 12 year data exclusivity period afforded biosimilars pursuant to the Biologics Price Competition and Innovation Act of 2009 (the “BPCI”) that was recently enacted in March 2010, as part of President Obama’s Patient Protection and Affordable Care Act (the “PPACA”), to create a biosimilar market in the US. In fact, the BPCI, itself, has been controversial and just barely survived judicial scrutiny when the US Supreme Court upheld the PPACA on June 28, 2012 in a 5-4 vote. Many commentators speculate whether data exclusivity will overtake patents as the preferred method of intellectual …

Intellectual Property And Agriculture: The Brazilian Case On Soybeans And Monsanto, Marcelo D. Varella

Marcelo D. Varella

This article analyzes different strategies of an agricultural company (Monsanto) to enforce intellectual property rights on soybeans in Brazil, during the last ten years. A court decision in April 2011 condemned Monsanto to pay up to 7.5 billion dollars in compensations. This is probably one of the most important cases on discussion on IPR and Agriculture today. On the one hand, there is complex company strategy to create intellectual property rights through patents, plant variety protections, import market controls, and thousands of agreements and extensions of those rights through different lawsuits. The strategy was complemented by the acquisition of major …

Securing The Future For The Nano Revolution In The United States, Katie M. Scholz

Katie M. Scholz

Nanotechnology promises huge potential for innovation in the coming decades. Globally, countries are scrambling to ensure they will not be left behind by building up their intellectual property regimes. Strong intellectual property leads to strong innovation. For the first time in modern history, the United States is not the prime contender for supremacy over this new field of technology. With the passage of the American Invents Act in September, the United States began the reform process. However, there are still many problems that need addressing including the training of patent players, dealing with the problems of university patenting, and educating …

Admissibility Of Dna Evidence: Italy Under Attack, Adina Rosenfeld

Adina Rosenfeld

The purpose of this paper is to compare the differences and similarities in the evidentiary rules for DNA in Italy and in the United States in the light of their two different legal traditions. This note will compare American and Italian rules of evidence and procedure for the admissibility of DNA in criminal trials and analyze the most relevant differences between the two systems. Based on this comparison, the note will argue that Amanda Knox would not have been convicted of murdering her roommate in American lower court because the DNA evidence would not have been admissible. In Italy, Knox …

The Large Immortal Machine And The Ticking Time Bomb, Susan Landau

Susan Landau

In 1994 Congress passed the Communications Assistance for Law Enforcement Act (CALEA). In many ways a rather extraordinary law, CALEA puts the government in charge of determining interception standards for telephone switches. Under CALEA, switches in use were to be retrofitted to accommodate the new requirement. That there were long-term consequences of building backdoors into long-lived electronic switching equipment were essentially ignored. That lapse is increasingly problematic. The possibility that security threats would develop against the telecommunications infrastructure itself does not appear to have been discussed during CALEA’s passage. The seriousness of the security lapse has become apparent with During …

The Criminal Justice System Creates Incentives For False Convictions, Roger Koppl, Meghan Sacks

Roger Koppl

We examine the incentive structure of the various actors of the criminal justice system within an organization economics framework. Specifically, we examine the incentives of the police, forensic scientists, prosecutors and public defenders. We find that police, prosecutors and forensic scientists often have an incentive to garner convictions with little incentive to convict the right person, whereas public defenders often lack the resources and incentives to provide a vigorous defense for their clients. The “multitask problem” of organizational economics helps explain how this skewed incentive structure creates false convictions.

Genomics Unbound: The Bright Future Of Genetic Testing And Therapy In Light Of Prometheus, Fazal Khan, Lindsay Kessler

Fazal Khan

This article sets out why gene patents are detrimental to society and further explains why the Supreme Court’s decision in Prometheus unfetters the field of genomics from thirty years of bad precedent. Certain vested interests in the biotechnology industry have long argued that gene patents are needed to promote innovation and ultimately benefits the public interest. However, using Myriad’s breast cancer gene patents on BRCA1 and BRCA2 as a case study, this article argues the opposite. Essentially, gene patents stifle research, impede patient access to affordable testing, and set back the development of new therapies. In addition, this article analyzes …

Twibel Law: What Defamation And Its Remedies Look Like In The Age Of Twitter, Ellyn M. Angelotti

Ellyn M Angelotti

In six years, the Twitter audience has quickly grown to 140 million users who can instantly publish to a global audience. The informal nature of conversations on Twitter makes it a ripe environment for the spreading of rumors and potential falsehoods. While a few Twibel suits have been brought to the forefront, the courts have yet to rule on a case in the United States. This article presents a hypothetical situation where an influential Twitter user posts false content about a local restaurant that rapidly spreads online. This results in the restaurant's demise. The defamed party considers bringing a defamation …

Necessity Is The Mother, But Protection May Not Be The Father Of Invention: The Limited Effect Of Intellectual Property Regimes On Agricultural Innovation, A. Bryan Endres, Carly E. Giffin

A. Bryan Endres

Standard innovation theory assumes that intellectual property protection is a prerequisite to the development of technological advances. Stretching back to the writing of the Constitution, a strong intellectual property system, comprised of both laws that establish intellectual property protection and a judicial or other adjudicative system to enforce the property right, has been considered necessary to stimulate innovation for the benefit of society. While not directly challenging this traditionally held belief, the authors used empirical data to test the assumption in the context of agriculture. This paper analyzed twenty years of agricultural production data from Argentina, Brazil, China, India, and …

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway

Fazal Khan

This article proposes a novel framework for more broadly securing the benefits of “off-label” drug usage while mitigating the harms inherent to this practice. Once the FDA approves a drug, doctors can prescribe for it any indication they think is reasonable, even uses that have not been thoroughly tested. The FDA bans the marketing or promotion for off-label uses by drug companies precisely because such uses have not been validated to be safe or effective through the regulatory process. Further, there are serious concerns with validity of industry-sponsored off-label research related to practices such as ghostwriting, gag-clauses on researchers, and …

Do Facebook And Twitter Make You A Public Figure?: How To Apply The Gertz Public Figure Doctrine To Social Media, Matt Lafferman

Matt Lafferman

In the last three years alone, defamation suits against internet users have risen by 216 percent due to the recent discovery that most homeowner’s insurance policies cover libel liability. This increase, which signals an almost inevitable rise in defamation suits, will eventually force courts to face the challenge of applying the Gertz public figure doctrine to social media. Courts face a particular dilemma when applying the doctrine to social media. The Supreme Court relied on two major rationales to delineate the Gertz doctrine: public figures “voluntarily exposed themselves to increased risk of injury” and had “significantly greater access to the …

Mistaken Assumptions: The Roots Of Stanford V. Roche In Post-War Government Patent Policy, Sean M. O'Connor

Sean M. O'Connor

The Bayh-Dole Act of 1980 was built on a mistaken assumption that “contractors”—recipients of federal funding—were securing assignments of inventions from their employees. The roots of this assumption go back to a 1947 Attorney General report on government patent policy that glossed over its own detailed finding that universities were in many cases not doing so. Because other types of contractors, including private firms and nonprofit research institutions, generally were securing title, the report concluded that “most” contractors were doing so. The report itself was the culmination of a century of confusing and conflicting legal developments with regard to both …

Genealogies Of Risk: Searching For Safety, 1930s-1970s, William Boyd

William Boyd

Health, safety, and environmental regulation in the United States is saturated with risk thinking. It was not always so, and it may not be so in the future. But today, the formal, quantitative approach to risk provides much of the basis for regulation in these fields, a development that seems quite natural, even necessary. This particular approach, while it drew on conceptual and technical developments that had been underway for decades, achieved prominence during a specific, and relatively short timeframe; roughly, between the mid 1970s and the early 1980s—a time of hard looks and regulatory reform. Prior to this time, …

Proof Of The Intelligent Construction Of The Universe, Ashley Saunders Lipson

Ashley Saunders Lipson

Traditionally, “Natural Law” has been loosely predicated upon unscientific notions of innate human morality and religion. For those seeking to link science and morality, Biology and its Darwinian tenets of survival have provided a dead end. Breaking with the past by using a few propositions of mathematics, this paper seeks to provide a scientifically defined purpose for the universe, and consequentially a new basis, in jurisprudence, for natural law. Once purpose is established, three abstract concepts flow directly from mathematics and physics into a natural order for natural law: Balance, Expansion, and Restraint. As a pseudo logic-based discipline, our historical …