Volume 14, Issue 1 (Winter 2013)

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The Post-Grant Problem: America Invents Falling Short
(2013-02-12) Fossen, Kayla
Prior to the passage of the Leahy-Smith America Invents Act (AIA), the United States operated a patent system that was in many ways unique among developed nations. The patent prosecution system in the United States was a slow, inefficient process. Patents were frequently invalidated, and those that were not invalidated required an inordinate amount of time and resources to defend. In an attempt to address these issues, Congress passed AIA. Under the new system many of the differences between the U.S. patent system and the European patent system have been harmonized, a new post-grant review process has been established, and the ability of third parties to participate has been significantly increased. The goal of this Note is to determine whether the new post-grant system established under AIA will ameliorate the issues identified by Congress as problematic within the current patent regime. Part I of this Note will describe the current international framework for patents as established by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the current United States patent regime, the current European patent regime, and the changes to the U.S. patent regime made by AIA. Part II compares the changes made by AIA—in particular changes regarding the new post-grant review—to the European system they are modeled after. Part III identifies failures and proposes a more selective pre-grant review system to address the failures. This Note concludes that, while the new patent regime created by AIA takes important steps towards addressing patent strength and litigation issues, under the current legal system a more stringent pre-grant review is necessary to meet the goals of AIA.
Do Educational Institutions Score High on Their Sustainability Efforts?: A Case Study (and Grade) on Chemical Waste Management and Minimization in Teaching and Research Laboratories at the University of Minnesota
(2013-02-12) Hanna, David
During a time when environmental issues flood the headlines of newspapers, magazine covers, and television broadcasts, it is hard not to come across sustainable efforts by “concerned” corporations and institutions trying to proactively tackle these environmental issues. With all the publicity associated with the color green stamped on a product or plastered across a campaign, it is easy for the less sustainable acts by these entities to slip through the cracks and go unnoticed. Waste management and minimization in university and college teaching and research laboratories is one of these areas. This Note studies chemical waste management and minimization in teaching and research laboratories at the University of Minnesota, one of the largest institutions by student enrollment in the country. By examining the issue of waste management and minimization at the University, this Note helps elucidate how universities and colleges have missed key areas of development and improvement of sustainability. Part II of this Note provides an overview on sustainability to help contextualize the role of chemical waste management and minimization. This Part discusses the federal and state legal infrastructure that governs waste management and minimization in university teaching and research laboratories in Minnesota and examines the regulations currently in place by the Department of Environmental Health and Safety (EHS). Finally, Part III evaluates this legal and regulatory framework and suggests proposals on how Minnesota lawmakers and regulatory agencies can model and incorporate the legal framework and infrastructure of other states into Minnesota’s current waste management regime. By implementing this legal and regulatory framework while considering current university waste disposal and regulation, Minnesota can reduce a considerable amount of university chemical waste—an amount that contributed to the University of Minnesota’s high ranking among Minnesota hazardous waste generators in 2009.
Addressing Looming Prescription Drug Shortages Through Legislative and Regulatory Approaches
(2013-02-12) Friske, Eric
An alarming increase in drug shortages in recent years presents a crisis affecting medical facilities across the nation, compromising patient care in a wide variety of serious illnesses. Many of the medications affected by these shortages are critical products, including oncology drugs, anesthetics, and antimicrobials. The frequency of drug shortages has steadily increased since 2005, nearly tripling over the span of five years. This Note proceeds in two parts. Part I provides back-ground on the recent drug shortage problems afflicting patients and medical facilities throughout the country and the current and proposed regimes available to address these problems. Part I.A provides background on the numerous underlying causes of drugs shortages, including the role of raw material supplies and manufacturing capabilities, and Part I.B examines the subsequent impact of shortages on patient care and the resources of medical facilities. Part I.C, Part I.D, and Part I.E explain the FDA’s existing drug shortage program, provide background on both the pending legislation in Congress meant to address current and future shortages, and the recent executive order issued in response to the shortage problem, respectively. Part II of this Note provides analysis of the proposed legislation for addressing the drug shortage problem and provides additional, alternative approaches for mitigating the occurrence and severity of shortages. This Note concludes that existing legislation makes important steps in assisting the FDA to adequately manage these shortages, but ultimately falls short of providing the multifaceted approach necessary to address the many underlying problems influencing these shortages.
Bringing Dormant GRAS(E) to Bloom: Reviving the GRASE Concept for Drugs
(2013-02-12) Puchalski, Emily
The cost of getting a new drug to market was estimated at $802 million in 2003, and more recent estimates have placed the cost at $1.3 billion and $1.7 billion. Making the commercial drug development process even more difficult, the time from initial development to use of a drug for patient treatment can be fifteen years. This expensive and time-intensive process produces many undesirable side effects including a low incentive to develop drugs for diseases primarily affecting the poor and competition from foreign countries with quicker approval processes. A partial solution may be found in § 321(p)(1) of Food, Drug, and Cosmetic Act, which could save certain drugs from the costs associated with the New Drug Application (NDA) required by the Food and Drug Administration (FDA) to get a new drug to market. The statutory provision applies to drugs that are “generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed.” Drugs falling within this provision have been referred to as “generally recognized as safe and effective,” or GRASE for short. The GRASE provision provides a mechanism to get these kinds of drugs to market more quickly. Despite the potential cost and time-saving benefits of GRASE, the standard for getting a drug designated as GRASE has been set so high that the provision has fallen out of use. The current GRASE system is broken and needs fixing. This Note presents previous proposals for lowering the cost and time requirements of FDA’s drug-approval process, concludes that the GRASE concept should be revived, and argues that a GRASE Notification System should be implemented because this system could lower the cost associated with drug development.
Developing a Durable Right to Health Care
(2013-02-12) Fuse Brown, Erin C.
The Patient Protection and Affordable Care Act’s (ACA) signature accomplishment was the creation of a statutory right to health care for the uninsured. This is a momentous change in policy, addressing one of the most vexing social issues of our time and affecting millions of people and billions of dollars of the U.S. economy. This ambition and the degree of societal and political debate leading up to the Act’s passage suggests that it is a “superstatute,” a rare breed of statute that can, among other things, create rights and institutions more typically thought to be the province of constitutional undertaking. Nevertheless, the structure of the ACA’s right to health care makes it fragile and reduces its chances of becoming a durable right. The ACA may end up as a “quasi-superstatute:” a statute that aspires but fails to become a superstatute through a failure of political and public entrenchment. The problem is that the right to health care is to be delivered largely through changes to the private health insurance market, requiring the collective action of many reluctant actors, including unwilling states and recalcitrant individuals. Even though it survived legal challenge before the Supreme Court, the ACA’s right to health care faces significant political and market challenges that threaten to retrench rather than entrench its benefits in the public’s mind. The vulnerability of this right to health care is concentrated early in its lifespan, and if it survives these early years, forces such as the endowment effect may strengthen the right’s durability as its benefits take hold. The fragility of the ACA’s right to health care and its uncertain path to durability provide lessons to future framers of a right to health care regarding the long timeframe for implementation, uncertainty, complexity, and structure. The risk of becoming a “quasi-superstatute” highlights the importance of how such social reforms ought to be structured to achieve entrenchment and durability after the ink is dry on the new legislation.
Mistake-Proofing Medicine: Legal Considerations and Healthcare Quality Implications
(2013-02-12) Grout, John R.; Hill, John W.; Langvardt, Arlen W.
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. 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. However, the adoption of such techniques in healthcare settings is more limited than expected. This article examines potentially useful mistake-proofing techniques, explores the largely unsound reasons why healthcare professionals have been slow to adopt such techniques, and explores the implications of mistake-proofing adoption (or lack thereof) for malpractice litigation and liability. Along the way, this article considers the undesirable effects of misperceptions on the part of healthcare professionals regarding their risks of being held liable in a malpractice case. This article also proposes ways of encouraging greater adoption of mistake-proofing techniques and other error-reduction practices in healthcare contexts.
Technopanics, Threat Inflation, and the Danger of an Information Technology Precautionary Principle
(2013-02-12) Thierer, Adam
Fear is an extremely powerful motivational force. In public policy debates, appeals to fear are often used in an attempt to sway opinion or bolster the case for action. Such appeals are used to convince citizens that threats to individual or social well-being may be avoided only if specific steps are taken. Often these steps take the form of anticipatory regulation based on the precautionary principle. Such “fear appeal arguments” are frequently on display in the Internet policy arena and often take the form of a full-blown “moral panic” or “technopanic.” These panics are intense public, political, and academic responses to the emergence or use of media or technologies, especially by the young. In the extreme, they result in regulation or censorship. This paper considers the structure of fear appeal arguments in technology policy debates, and then outlines how those arguments can be deconstructed and refuted in both cultural and economic contexts. Several examples of fear appeal arguments are offered with a particular focus on online child safety, digital privacy, and cybersecurity. To the extent that these concerns are valid, they are best addressed by ongoing societal learning, experimentation, resiliency, and coping strategies rather than by regulation. If steps must be taken to address these concerns, education and empowerment-based solutions represent superior approaches to dealing with them compared to a precautionary principle approach, which would limit beneficial learning opportunities and retard technological progress.
The Flaws of Stem Cell Legislation: Sherley, Brüstle, and Future Policy Challenges Posed by Induced Pluripotent Stem Cells
(2013-02-12) Diamond, Nicholas J.
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, will require substantial revision so as to not unnecessarily encumber the ever-growing therapeutic promise of stem cell research.
Cyber-threats and the Limits of Bureaucratic Control
(2013-02-12) Brenner, Susan W.
For over half a decade, the author has been writing about how and why the institutions modern nation-states rely on to fend off the threats––war, crime, and terrorism––that can erode their ability to maintain order and compromise their viability as sovereign entities become ineffective when the threats migrate into cyberspace. In a succession of law review articles and books, the author refined her analysis of the essentially unprecedented challenges cybercrime, cyberterrorism and cyberwarfare pose for law enforcement and the military. The goal of this article is to go beyond critiquing the efficacy of the current threat-control structures and outline an alternative approach. The current approach, which appropriately focuses on remediating specific factors that contribute to the inefficacy with which current United States threat-control structures confront cyber-threats, is inadequate because it seeks to “update” systems that were developed to control threats that were simpler and more parochial than the ones we confront now. The author does not believe existing threat-control structures can be modified in ways that will make them effective against the twenty-first century threats many countries already confront, and most, if not all, will eventually confront. Like others, the author believes we need a new threat-control strategy: one that replaces the rigid, hierarchical structures on which we currently rely, with systems that mirror the lateral, networked structures that prosper in cyberspace. This article outlines how such a strategy could be structured and implemented.
DIOS MIO—The KISS Principle of the Ethical Approach to Copyright and Right of Publicity Law
(2013-02-12) Murray, Michael D.
To copy or not to copy, to exploit the famous celebrity image or not to exploit it; these are the questions. The message of the modern legal world communicated through multiple voices in the academy is that copying often is perfectly acceptable and even laudable. An artist or designer might conclude that it is both legal and ethical to use whatever you can, use whatever you can get away with, and use it until you get sued for using it. Yet plagiarism in the arts and sciences is nearly universally condemned. This Article proposes an ethical approach to the use of copyrighted works and names, images, and likenesses protected by the right of publicity. This approach is based on the ethical requirements of the law as synthesized from the cases presenting concrete narratives concerning fair and appropriate uses of protected works, names, and images. My thesis may be summed up in a revised form of the KISS principle (Keep it simple, stupid!) known as "DIOS MIO: Don’t Include Other’s Stuff or Modify It Obviously". Although simplified to this acronym, the ethical considerations concerning copyright-protected works and right of publicity-protected names and images are far from simple. The advice of this Article reflects the convergence of predominant purpose analysis and transformative/transformation analysis in copyright and right of publicity law that has led to a single set of recommendations for the legal and ethical treatment of protected works and celebrity names, images, and likenesses: seek first to create and not to copy or exploit, and create new expression by obvious modification of the old expression and content.
Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice
(2013-02-12) Wolf, Leslie E.; Patel, Mayank J.; Williams, Brett A.; Austin, Jeffrey L.; Lauren A., Dame
Researchers often require and collect sensitive information about individuals to answer important scientific questions that impact individual health and well-being and the public health. Researchers recognize they have a duty to maintain the confidentiality of the data they collect and typically make promises, which are documented in the consent form. The legal interests of others, however, can threaten researchers’ promises of confidentiality, if they seek access to the data through subpoena. Certificates of Confidentiality (Certificates), authorized by federal statute, are an important tool for protecting individually identifiable sensitive research data from compelled disclosure. However, questions persist in the research community about the strength of Certificate protections, and the evidence on which to judge the strength is scant. In this article, we address those questions through a careful examination of the legislation and regulations concerning Certificates and the reported and unreported cases we have identified through our legal research and interviews with legal counsel about their experiences with Certificates. We also analyze other statutes that protect research data to compare them to the Certificate’s protections, and we review other legal strategies available for protecting research data. Based on our analysis, we conclude with recommendations for how to strengthen protection of sensitive research data.
Chimeric Criminals
(2013-02-12) Kaye, David H.
According to some commentators, an obscure genetic condition known as chimerism “could undermine the very basis of the forensic DNA system” and force a reconsideration of “the entire project of forensic DNA.” This conclusion is as unfounded as it is unnerving. Chimerism is a consideration in, but not a real obstacle to DNA identification. This essay explains why.