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

The Application of Data Access Policies Designed for Genome-Wide Association Studies to Smaller Scale Databases, 10 J. Marshall Rev. Intell. Prop. L. 476 (2011)

Scientific progress thrives with open discussion of new ideas and supporting data. To this end, researchers traditionally publish their results in scientific papers—papers that contain the new ideas and the underlying data supporting those ideas. With the advent of large-scale and high-throughput data analysis, however, the creation of scientific databases have replaced the traditional model. For such publically-funded, data-intensive projects, funding agencies typically require that all relevant data be made available on a publicly accessible website at the time of the paper’s publication. Against the backdrop of the public accessibility model used in the 1000 Genomes Project, the author recommends that a modified framework be applied to smaller scale data collection projects. Such a framework could overcome the data producers’ concern for protecting the data they have created, thereby encouraging researchers to share data from smaller scale studies