Finding a Regulatory Balance for Genetic Biohacking

“Biohacking” has emerged as a cultural and scientific phenomenon. Although there is no consensus on the precise definition of “biohacking,” the term generally describes biological investigations and interventions that are conducted outside of typical scientific settings by individuals who may not have traditional scientific training. Easier access to biological information and resources has enabled biohacking to flourish. Its participants often describe their activities as motivated by a belief in a right to “do science,” a high value placed on bodily autonomy, and a view that traditional scientific institutions and regulations have systematically failed to benefit society. At the same time, the November 2018 announcement that a scientist in China used CRISPR to genetically modify viable human embryos — allegedly resulting in the birth of the first “CRISPR babies” — has reinvigorated concerns about the distribution of genetic technologies. For genetic biohacking, these concerns may be heightened by a belief that mechanisms to regulate the activity are absent or inadequate to address its risks. But, as this chapter details, genetic biohacking is likely subject to numerous oversight mechanisms, both public and private. Before calling for additional regulations, these extant mechanisms should be evaluated.Ope

The Rise of the Ethical License

The Broad Institute's recent licensing of its gene editing patent portfolio demonstrates how licenses can be used to restrict controversial applications of emerging technologies while society deliberates their implications.Ope

Fresh takes on five health data sharing domains: Quality, privacy, equity, incentives, and sustainability

As entities around the world invest in repositories and other infrastructure to facilitate health data sharing, scalable solutions to data sharing challenges are needed. We conducted semi-structured interviews with 24 experts to explore views on potential issues and policy options related to health data sharing. In this Perspective, we describe and contextualize unconventional insights shared by our interviewees relevant to issues in five domains: data quality, privacy, equity, incentives, and sustainability. These insights question a focus on granular quality metrics for gatekeeping; challenge enthusiasm for maximalist risk disclosure practices; call attention to power dynamics that potentially compromise the patient's voice; encourage faith in the sharing proclivities of new generations of scientists; and endorse accounting for personal disposition in the selection of long-term partners. We consider the merits of each insight with the broad goal of encouraging creative thinking to address data sharing challenges

Psychological Distress Among the U.S. General Population During the COVID-19 Pandemic

The COVID-19 pandemic is taking a significant global toll on emotional well-being, but evidence of mental health impacts in the United States remains limited. In April 2020, we conducted an exploratory survey of U.S. residents to understand prevalence of and factors associated with psychological distress during the pandemic. Data collection was conducted using Qualtrics, an online survey platform, and U.S. adult respondents were recruited via Amazon's Mechanical Turk platform. Among 1,366 respondents, 42% (n = 571) reported clinically significant anxiety and 38% (n = 519) reported clinically significant depression. Factors associated with anxiety and depressive symptoms included Hispanic/Latino ethnicity; younger age; lower income; employment as or living with a health care worker-first responder; caregiver status; SARS-CoV-2 infection status; decreased frequency of engagement in healthy behaviors; and changed frequency of engagement in unhealthy behaviors. That some of these factors are associated with elevated distress during the pandemic is not yet widely appreciated and might be useful in informing management of mental health care resources

The Decline of the Patent Registration Exam

This Article focuses on the PTO’s management of the patent registration exam instead of one of the agency’s other non-examining responsibilities for three reasons. First, as already mentioned, a critical analysis of the exam has not yet been conducted and is overdue. Second, because the PTO’s exam-related responsibilities are well defined and relatively narrow, the quality of the PTO’s execution of them can be examined in some detail. Finally, the subject presents a unique opportunity to gather and study a set of primary sources that to my knowledge has not yet been subjected to any kind of scholarly analysis: the exams themselves. Thus, in researching this Article, I collected eighty-one registration exams administered over the course of forty-nine non-consecutive years, with each full decade represented by at least five years’ worth of exams. Copies of many of these exams were obtained in response to Freedom of Information Act (FOIA) requests to the PTO. Because these documents are not otherwise easily accessed, they will be published in connection with this Article on a webpage hosted by the University of Houston Law Center’s Institute for Intellectual Property and Information Law. It should be noted that passage of a written exam is only one requirement that must be satisfied to become a registered patent prosecutor. The other major requirement is proof of technical competency in the form of education or training in a recognized scientific or engineering discipline. This Article is limited to a consideration of the exam requirement, the technical requirement having already been analyzed by other scholars. Nevertheless, the two requirements necessarily overlap since a patent’s validity and strength can be diminished by the drafter’s technical incompetence even where the drafter’s legal competence is not an issue. Part II of this Article describes the historical circumstances that led to the adoption of the exam requirement. Part III then describes the evolution of the exam from its first administration in 1934 and continuing to the present day. The story these exams tell is that the patent registration exam was the subject of continual tinkering by the Patent Office, with changes made at least every decade and sometimes every year. Notwithstanding these frequent adjustments, some patterns emerge. Specifically, for the first few decades of its history, the Patent Office endeavored to make the exam more rigorous and comprehensive. But as the twentieth century came to an end, practical considerations stemming from a shortage of funds and labor took precedence over quality when the PTO introduced changes to the exam that have had the effect of impairing its quality. I describe these failures in terms of modern psychometric standards that apply to professional licensure exams and conclude that the U.S. patent registration exam is today an invalid, unreliable, and unfair assessment of readiness to practice. Part IV describes the consequences of the exam’s failures, which include wasting the agency’s and examinees’ valuable time and resources and undermining confidence in the PTO’s institutional legitimacy. Finally, Part V concludes that the exam likely has continued relevance and so is worthy of efforts to improve it. Among other things, I propose that the PTO outsource most of its exam-related responsibilities to an independent testing expert and enforce copyrights that consequently would attach to test forms, questions, and answers. These suggestions for change should not be too difficult to implement and would almost certainly improve the quality of the exam

Defining Patent Quality

Depending on whom you ask, the state of U.S. patent quality is either dismal or decent, in decline or on the upswing, in need of intervention or best left alone. Absent from the ongoing debate about the quality of U.S. patents, however, is much thoughtful discussion about what constitutes a patent’ “quality” in the first place. What features of a patent make it “good” in quality, what features make it “bad” in quality, and whose opinion matters? Surprisingly, scholars and policymakers have shown little interest in these questions. Yet their answers are critical to the direction of the patent agenda because they dictate how to measure patent quality and, consequently, how to evaluate the extent of the so-called patent quality “crisis” as well as the effectiveness of quality reforms. The broad aim of this Article is to draw attention to the definition of patent quality as an important subject of scholarly inquiry. Its more specific aim is to call for a return to first principles and begin the process of operationalizing the meaning of patent quality. It does so by analyzing the concept using a methodology applied in the business literature of quality management. The implications of this work include a fundamentally different approach to patent quality’s meaning that is essentially the inverse of the conventional way of thinking about the concept. That is, instead of defining a good-quality patent as one that, at a minimum, satisfies the existing legal standards of patentability, the legal standards of patentability (among other things) should be adjusted and applied to reflect good patent quality. Following this new approach, I propose a formula for assessing patent quality and identify the most important variable in that formula: the quality “dimensions” along which patent quality can be said to rise and fall. Identifying these dimensions is the necessary first step in a process that ultimately aims to shift the focus of reform efforts from the limited goal of increasing the number of legally valid patents toward the more relevant goal of increasing the number of good-quality patents

Genomic Innovation, Intellectual Property, and Public Health: A Qualitative Study

Concern is mounting that recent changes to the law of patentable subject matter have weakened patent protection and that innovators are responding or soon may respond by increasingly choosing to protect their discoveries as trade secrets. With respect to biomedical discoveries, there is also concern that such a trend will negatively impact public health. This study sought to assess the validity of these concerns as applied to genomic innovations. ^ While it is impossible to quantify the extent to which innovators actually elect to protect their inventions as trade secrets rather than patents, interest in each strategy may be gauged through qualitative means. Utilizing expert interviews of 30 patent practitioners (attorneys and agents), legal academics, and scientists, this study probed the following predictions: (1) since 2012, the perceived advantages of patenting genomic innovations have decreased; and (2) since 2012, interest in protecting genomic innovations as trade secrets has increased. Interviews were conducted according to a semi-structured format using guides comprised of open-ended contextual and evaluative questions, and transcripts were analyzed according to conventional content analysis. ^ The data generally support the conclusion that, on the margins, trade secrecy is replacing patent protection where it is practical to do so and that this result is at least in part due to recent changes to the law of patentable subject matter. The data also support concerns that a shift in intellectual property strategies from patenting to trade secrecy may have important public health implications with respect to the translation of genomic discoveries to medical solutions.