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Association for Molecular Pathology v. Myriad Genetics: A Critical Reassessment
Get PDFThe Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is part of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Sec-tion 101 jurisprudence. Perhaps one of the most remarkable things about Myriad is that it meant so many different things to so many different people. It was seen, and tried, as a case impacting patient rights, access to healthcare, scientific freedom, and human dignity. In this article, portions of which will appear in a forthcoming book, I offer a close textual analysis of the Myriad decision, responding to both its critics and supporters. I then situate Myriad within the larger context of biotechnology patenting, the commercialization of publicly funded university research and the U.S. healthcare system. I conclude with observations about the ways that cases like Myriad exemplify the manner in which the common law evolves, particularly in areas of rapid technological change
Bystander Legislation: He Ain\u27t Heavy, He\u27s My Brother
Get PDFIn this article we address the bystander with a particular focus on legislating-criminalizing the bystander. In doing so we focus on bystander responsibility from the perspective of the individual in peril. Why and how the individual is in that condition is irrelevant to the recommendation that a duty to act be imposed on the bystander. The circumstances that directly, or indirectly, led to the distress are insignificant to the legal obligation to intervene on behalf of the person in immediate physical peril.The bystander is the person who observes another individual in distress, knows of that person’s travail, and has the capability to act on their behalf. The bystander is present at the moment of another person’s acute need. The question is whether the bystander will act on behalf of that person or not act by choosing to walk away. Re-stated, will the bystander provide assistance or deliberately and knowingly ignore, thereby committing a crime of omission? We define assistance narrowly: just dial “911,” thereby alerting the authorities as to the dire circumstances of another individual. Adoption of legislation would punish the bystander for failing to provide the victim with concrete assistance. Commensurate with a significant educational undertaking, it would also serve as a deterrent to the broader public: failure to provide assistance to the person in peril will result in criminal prosecution
Inescapable Surveillance
Get PDFUntil recently, Supreme Court precedent dictated that a person waives their Fourth Amendment rights in information they disclose to another party. The Court reshaped this doctrine in Carpenter v. United States, establishing that the Fourth Amendment protects cell phone location data even though it is revealed to others. The Court emphasized that consumers had little choice but to disclose their data, because cell phone use is virtually inescapable in modern society.In the wake of Carpenter, many scholars and lower courts have endorsed inescapability as an important factor for determining Fourth Amendment rights. Under this approach, surveillance that people cannot feasibly escape receives more Fourth Amendment scrutiny, while surveillance that can be avoided receives less, or none.This Article offers the first systematic analysis of inescapability in Fourth Amendment law. It challenges the prevailing wisdom that inescapability is a desirable or workable basis for Fourth Amendment protection. Inescapability does not provide a conceptually coherent standard for courts to apply. It incentivizes consumers to forego beneficial technologies, creating substantial social harms. It fails to adequately protect the most sensitive forms of personal information. It creates doctrinal confusion and ignores established precedents that contradict the inescapability model. Moreover, inescapability analysis elides individual differences — technologies that are avoidable for most people may be unavoidable for others, including the disabled, the poor, and other disadvantaged populations.Inescapability threatens to limit privacy rights to a narrow set of digital technologies while making a mess of Fourth Amendment doctrine. This Article analyzes these issues in depth and explores several alternatives for determining Fourth Amendment protections in the digital age
Up in the Air: A Fifty-State Survey of Atmospheric Trust Litigation Brought by Our Children’s Trust
Get PDFFrustrated by government inaction in response to the threats posed by anthropogenic climate change, the advocacy organization Our Children’s Trust (OCT) is pursuing legal reform in every state in the United States. These efforts include petitioning state environmental agencies for rulemaking and filing lawsuits against those agencies and the states. The legal claims have generally been rooted in the public trust doctrine. This Note surveys OCT’s efforts and the evolution of the organization’s legal strategy, as OCT has recently based its lawsuits on violations of substantive due process, and in some cases, violations of the states’ own environmental laws. This Note summarizes the results of OCT’s lawsuits thus far and the possible significance of their outcomes
Indigenous Rights and Climate Change: The Influence of Climate Change on the Quantification of Reserved Instream Water Rights for American Indian Tribes
Get PDFThe people indigenous to the Western portion of the lands now referred to as North America have relied on aquatic species for physical, cultural, and spiritual sustenance for millenia. Such indigenous peoples, referred to in the American legal system as Indian tribes, are entitled to water rights for fish habitat pursuant to the Winters Doctrine, which holds that the federal government impliedly reserved water rights for tribes when reservations were created. Recently, the methodology for quantifying these rights has been the Instream Flow Incremental Methodology (IFIM) and/or one of its major components, the Physical Habitat Simulation Model (PHABSIM). These models result in water right claims for fixed quantities of water, which—although not required by law—result in instream water rights that are decreed without any means for adjustment to account for changing conditions. Ultimately, climate change will likely alter the amount of water necessary to protect aquatic habitat, rendering obsolete any water right that is based on a fixed quantity. As climate change continues to worsen, we argue that quantifying reserved water rights for inflexible fixed quantities imposes an unreasonable burden on American Indian tribes. Instead, we suggest the application of a number of integrated technical and legal solutions to mitigate the uncertainty Indian tribes currently face from climate change as they seek to protect their rights, resources, and homelands
Why We Fear Genetic Informants: Using Genetic Genealogy to Catch Serial Killers
Get PDFConsumer genetics has exploded, driven by the second-most popular hobby in the United States: genealogy. This hobby has been co-opted by law enforcement to solve cold cases, by linking crime-scene DNA with the DNA of a suspect\u27s relative, which is contained in a direct-to-consumer (DTC) genetic database. The relative’s genetic data acts as a silent witness, or genetic informant, wordlessly guiding law enforcement to a handful of potential suspects. At least thirty murderers and rapists have been arrested in this way, a process which I describe in careful detail in this article. Legal scholars have sounded many alarms, and have called for immediate bans on this methodology, which is referred to as long-range familial searching ( LRFS ) or forensic genetic genealogy ( FGG ). The opponents’ concerns are many, but generally boil down to fears that FGG will invade the privacy and autonomy of presumptively innocent individuals. These concerns, I argue, are considerably overblown. Indeed, many aspects of the methodology implicate nothing new, legally or ethically, and might even better protect privacy while exonerating the innocent. Law enforcement’s use of FGG to solve cold cases is a bogeyman. The real threat to genetic privacy comes from shoddy consumer consent procedures, poor data security standards, and user agreements that permit rampant secondary uses of data. So why do so many legal scholars fear a world where law enforcement uses this methodology? I submit that our fear of so-called genetic informants stems from the sticky and long-standing traps of genetic essentialism and genetic determinism, where we incorrectly attribute intentional action to our genes and fear a world where humans are controlled by our biology. Rather than banning the use of genetic genealogy to catch serial killers and rapists, I call for improved DTC consent processes, and more transparent privacy and security measures. This will better protect genetic privacy in line with consumer expectations, while still permitting the use of LRFS to deliver justice to victims and punish those who commit society\u27s most heinous acts
Expanding Access to Patents for COVID-19
Get PDFTwo competing and linked sets of goals must be addressed when considering patent policy in response to a public health emergency. First is the allocation of existing resources among potential users (hospitals, patients, etc.); second is the creation of new technologies over time (innovation). Patents provide financial incentives to develop new technologies. Yet shortages of patented products often plague crisis response. In the case of COVID-19, allocative goals, particularly satisfying demand for patented medical products (e.g., vaccines, ventilators, PPE, and test kits), may be achieved through governmental interventions such as march-in and governmental use rights (compulsory licensing). But in cases involving the development of new technologies such as vaccines and therapies, incentive structures must be preserved to ensure that the private sector is appropriately motivated to act. In addition to patents, which reward inventors for financially successful innovations, a range of other incentives such as prizes, grants, and subsidies also exist to motivate technological innovation. Incentives like these, coupled with a requirement that resulting discoveries be made available on a broad and open basis, can achieve a balance between allocation and innovation goals. Governments can encourage such measures using both the incipient threat of compulsory licensing and the reward of procurement preferences and other up-front rewards.This paper was prepared as part of Assessing Legal Responses to COVID-19, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association
Trying Times: Conservation Easements and Federal Tax Law (Sept. 2020)
No full textSince 2005, the courts have decided more than 90 cases involving challenges to deductions claimed with respect to conservation easement donations. More than 135 opinions have been issued in these cases due to appeals, motions for reconsideration, and the issuance of separate opinions addressing specific issues. This outline, which is updated annually, discusses the case law and other developments in the conservation easement donation context
Changing Consultation
No full textAs climate change and fossil fuel extractive industries threaten Indian country and burden many Indigenous communities with risks, mitigating the negative impacts on tribal sovereignty, health, and cultural integrity demands consultation between tribes and the federal government. Yet, this is an area where the law fails to provide adequate guidance to parties who should be engaging or are already engaging in tribal consultations. The law, both domestic and international, may require that consultation occurs, but leaves parties to determine themselves what constitutes effective and efficient consultation. The legacy of the law’s inability to provide effective guidance has generated numerous cases of litigation and mutual hard feelings, a glaring example being how the legitimacy of consultative activities was debated and misunderstood in the Standing Rock Tribe’s resistance against the Dakota Access Pipeline. This Article hopes to fill the void by turning to other disciplines — ethics and Indigenous studies — for guidance on how effective consultation may be achieved.
To accomplish this, the Article begins with an examination of relevant domestic and international law. While true that claims exist under both domestic and possibly international law to require the federal government to engage in government-to-government consultation with tribes, very little guidance is given as to what that consultation should look like and which sovereign, whether the tribe or the federal government, gets to dictate the process of consultation. Further, existing domestic and international law provides little as to the scope of such consultation or when it is triggered. Given the law’s inability to fully answer the question of what effective consultation looks like, the Article suggests that ethics literature, especially the literature emerging from Indigenous studies, is helpful in framing normative judgments regarding effective consultation.
From a moral perspective, consultation can be linked to the norm that all parties should have a chance to give their free, prior, and informed consent to the actions of any other party whose actions may impact them in some way. Impacts include harms or opportunities to share in any future benefits. In the literature on ethics, “free,” “prior,” and “informed” consent are taken as being defined in certain ways. While there are a range of legal and other purposes for consultation, morally speaking, consultation can be understood as one process or strategy for fulfilling the general moral duty of consent. Further, emerging Indigenous studies literatures pertaining to ethics add additional moral requirements to these definitions.
The idea of consent, as a moral norm, suggests a relationship between the U.S., tribes, and other parties that would flow much more like a partnership than a formal consultation, and where tribes would have veto rights (the right to say “no”) to any actions that would impact them. To demonstrate this concept, the Article presents two examples: the Dakota Access pipeline controversy, an example of ineffective consultation, and the Northwest Forest Plan, an example of deliberate approaches to monitor the effectiveness of consultation. Based on these examples combined with the ethics literature, the Article concludes with specific strategies that parties might employ to ensure successful tribal consultations. Beyond filling the void created by current federal law, the Article therefore constitutes a valuable and unique addition to the existing scholarship in its interdisciplinary approach, and guidance to parties engaged in tribal consultations
Intellectual Property Rights and the Rule of Law
Get PDFThe subject of this conference is the “Rule of Law”, so I would like to address my opening comments to a trending narrative that casts opposition to the demands of patent holders as a form of lawlessness. This narrative specifically takes aim at a practice that has been termed “efficient infringement” – the idea that a firm may rationally decide to infringe patents either because it will be too costly for the patent holder to enforce its rights in court, or because it is happy to take its chances in court, where an asserted patent may be invalidated and where damages eventually assessed against the infringer years later will likely be no higher than the royalties that the infringer would have paid anyway under a licensing agreement