Should the United States Designate Specialist Patent Trial Judges? An Empirical Analysis of H.R. 628 in Light of the English Experience and the Work of Professor Moore

The United States Court of Appeals for the Federal Circuit currently reverses from one-third to nearly one-half of all U.S. district court patent claim construction decisions. Because claim construction often determines the outcome of patent litigation, the high appellate claim construction reversal rate contributes to significant uncertainty among inventors and investors. Congress is currently considering legislation, H.R. 628, which will designate specialist district court patent judges to reduce this unacceptably high reversal rate.This Article concludes that designation of specialist patent trial judges among the federal district court judiciary is likely to reduce the high appellate claim construction reversal rate, based upon an empirical analysis of the appellate claim construction reversal rate in England, which has specialized patent tribunals. Part I of the Article examines proposed U.S. legislation that would designate specialized patent trial judges. Part II analyzes the patent claim construction process in the United States, enumerating the challenges faced by generalist U.S. district court judges charged with deciding highly complex patent litigation actions. Part III then examines the English patent claim construction process, drawing numerous parallels between patent litigation in the United States and England that render the English system a valid comparator when considering the respective appellate claim construction reversal rates in the two jurisdictions. Part IV presents empirical results that strongly support the notion that designation of specialist patent trial judges in the United States could indeed decrease the appellate claim construction reversal rate, thereby affording certainty to patent litigants and investors. Part V then explains why the approach proposed in H.R. 628 is superior to the current English system of specialized patent trial courts

The Ethics of Big Data in Genomics: The Instructive Icelandic Saga of the Incidentalome

DeCODE Genetics, Inc., a pioneering Icelandic biotech firm, recently introduced a free website that permits Icelanders to learn whether they carry mutations in the BRCA2 gene that are known to increase cancer risk, even if these citizens have never participated in genetic testing. Approximately five thousand Icelanders have elected thus far to receive their status. This site is made possible by the consanguinity of Icelandic citizens, who number fewer than 350,000, and their detailed genealogical records dating back centuries, a set of circumstances that presents a unique opportunity to study genetic mutations and the medical disorders associated with them. Using such information, deCODE has the ability to impute genetic information about individuals without any legal requirement to obtain their informed consent. This ability to impute individuals’ genotypes without having gathered bio-specimens or medical information directly from them calls into question researchers’ duty to inform individuals about their health risks, and the individuals’ right not to know (“RNTK”), defined as the idea that people ought to be able to control their receipt of genetic information about themselves. The emergence of unanticipated and yet highly significant genetic findings is referred to as the “incidentalome.” Commentators use the phrase “incidental findings” (“IFs”) to refer to medically important information that arises from research but is unrelated to the goals of that research. This article analyzes the return by researchers of genetic IFs to individuals whose genotypic data has been imputed, and who therefore have not indicated their consent to receive such information. While Iceland is at the forefront of this issue due to its small, homogeneous population, other nations increasingly encounter the same need to balance individual autonomy with responsibility for public health. Part II of this Article will consider the global rise of biobanks and the concomitant challenges posed to the right not to know. Part III considers how the incidentalome arises in Iceland, a country renowned for its genomic research, while Part IV examines the current debate in Iceland regarding the release of imputed genomic information to its citizens. International laws and norms regarding the RNTK are the subject of Part V. Part VI of this Article explores the legal and ethical arguments surrounding the three possible approaches considered in Iceland for the release of imputed BRCA2 genetic data: no return of the data; make it publicly known that the information is available and thus enable individuals to take the initiative to request that information for themselves; or contact the affected individuals directly to inform them that researchers possess information relevant to their health. Because similar legal and ethical questions arise when health care providers consider their duty to inform individuals exposed to HIV and AIDS, Part VII analyzes considerations surrounding the provision of this risk information. Finally, Part VIII of this Article proposes an approach for the future, emphasizing the need for a robust public service campaign that encourages individuals to access their imputed genetic data and, more broadly, for expanded governmental investment in and public access to genetic testing

Analyzing Medication Documentation in Electronic Health Records: Dental Students’ Self-Reported Behaviors and Charting Practices

The aim of this two-part study was to assess third- and fourth-year dental students’ perceptions, self-reported behaviors, and actual charting practices regarding medication documentation in axiUm, the electronic health record (EHR) system. In part one of the study, in fall 2015, all 125 third- and 85 fourth-year dental students at one U.S. dental school were invited to complete a ten-item anonymous survey on medication history-taking. In part two of the study, the EHRs of 519 recent dental school patients were randomly chosen via axiUm query based on age >21 years and the presence of at least one documented medication. Documentation completeness was assessed per EHR and each medication based on proper medication name, classification, dose/frequency, indication, potential oral effects, and correct medication spelling. Consistency was evaluated by identifying the presence/absence of a medical reason for each medication. The survey response rate was 90.6% (N=187). In total, 64.5% of responding students reported that taking a complete medication history is important and useful in enhancing pharmacology knowledge; 90.4% perceived it helped improve their understanding of patients’ medical conditions. The fourth-year students were more likely than the third-year students to value the latter (p=0.0236). Overall, 48.6% reported reviewing patient medications with clinic faculty 76-100% of the time. The respondents’ most frequently cited perceived barriers to medication documentation were patients’ not knowing their medications (68.5%) and, to a much lesser degree, axiUm limitations (14%). Proper medication name was most often recorded (93.6%), and potential oral effects were recorded the least (3.0%). Medication/medical condition consistency was 70.6%. In this study, most of the students perceived patient medication documentation as important; however, many did not appreciate the importance of all elements of a complete medication history, and complete medication documentation was low

Narrowing the wingless-2 mutation to a 227 kb candidate region on chicken chromosome 12.

Wingless-2 (wg-2) is an autosomal recessive mutation in chicken that results in an embryonic lethal condition. Affected individuals exhibit a multisystem syndrome characterized by absent wings, truncated legs, and craniofacial, kidney, and feather malformations. Previously, work focused on phenotype description, establishing the autosomal recessive pattern of Mendelian inheritance and placing the mutation on an inbred genetic background to create the congenic line UCD Wingless-2.331. The research described in this paper employed the complementary tools of breeding, genetics, and genomics to map the chromosomal location of the mutation and successively narrow the size of the region for analysis of the causative element. Specifically, the wg-2 mutation was initially mapped to a 7 Mb region of chromosome 12 using an Illumina 3 K SNP array. Subsequent SNP genotyping and exon sequencing combined with analysis from improved genome assemblies narrowed the region of interest to a maximum size of 227 kb. Within this region, 3 validated and 3 predicted candidate genes are found, and these are described. The wg-2 mutation is a valuable resource to contribute to an improved understanding of the developmental pathways involved in chicken and avian limb development as well as serving as a model for human development, as the resulting syndrome shares features with human congenital disorders

Outbreak of encephalitic listeriosis in red-legged partridges (Alectoris rufa)

An outbreak of neurological disease was investigated in red-legged partridges between 8 and 28 days of age. Clinical signs included torticollis, head tilt and incoordination and over an initial eight day period approximately 30–40 fatalities occurred per day. No significant gross post mortem findings were detected. Histopathological examination of the brain and bacterial cultures followed by partial sequencing confirmed a diagnosis of encephalitis due to Listeria monocytogenes. Further isolates were obtained from follow-up carcasses, environmental samples and pooled tissue samples of newly imported day-old chicks prior to placement on farm. These isolates had the same antibiotic resistance pattern as the isolate of the initial post mortem submission and belonged to the same fluorescent amplified fragment length polymorphism (fAFLP) subtype. This suggested that the isolates were very closely related or identical and that the pathogen had entered the farm with the imported day-old chicks, resulting in disease manifestation in partridges between 8 and 28 days of age. Reports of outbreaks of encephalitic listeriosis in avian species are rare and this is to the best of our knowledge the first reported outbreak in red-legged partridges

Knowledge Transfer and Teaching Public Administration: the Academy Model

Since the beginnings of Public Administration in the US and its accompanying education in other parts of the world, government and policy have become more complex. The education in Public Administration created a professional pathway to public service. The addition of education to Public Administration came out of the Progressive Movement in the United States to make knowledge in Public Administration more important in the face of corruption brought on by patronage appointments. When nonprofits became part the US public sector as elsewhere along with nonprofit healthcare, the complexity expanded enormously, requiring professionals to know more in what has become a multidisciplinary field of study. Given the diversity and complexity of the public sector and the need for Public Administration to embrace more knowledge from many disciplines, it stands to reason that an earlier start on the education portion of Public Administration or a pathway would be beneficial. A model of early Public Administration knowledge transfer is described and illustrated below. The Academy described is based on the US career pathways and high school academies as part of the school to work educational movement. The success of the combination of these two areas will also be pointed out in the academy described. Translation of lessons learned from the Acdemy to Europe and Asia are also considered

An Open-Publishing Response to the COVID-19 Infodemic

The COVID-19 pandemic catalyzed the rapid dissemination of papers and preprints investigating the disease and its associated virus, SARS-CoV-2. The multifaceted nature of COVID-19 demands a multidisciplinary approach, but the urgency of the crisis combined with the need for social distancing measures present unique challenges to collaborative science. We applied a massive online open publishing approach to this problem using Manubot. Through GitHub, collaborators summarized and critiqued COVID-19 literature, creating a review manuscript. Manubot automatically compiled citation information for referenced preprints, journal publications, websites, and clinical trials. Continuous integration workflows retrieved up-to-date data from online sources nightly, regenerating some of the manuscript\u27s figures and statistics. Manubot rendered the manuscript into PDF, HTML, LaTeX, and DOCX outputs, immediately updating the version available online upon the integration of new content. Through this effort, we organized over 50 scientists from a range of backgrounds who evaluated over 1,500 sources and developed seven literature reviews. While many efforts from the computational community have focused on mining COVID-19 literature, our project illustrates the power of open publishing to organize both technical and non-technical scientists to aggregate and disseminate information in response to an evolving crisis