Patenting Frankenstein’s Monster: Exploring the Patentability of Artificial Organ Systems and Methodologies

The conception of Frankenstein’s monster bridges the ever-narrowing divide between man and machine. Long before Congress codified Section 33(a) of the America Invents Act (“AIA”), Mary Shelley’s vague description of the monster’s creation has left people wondering: what defines a human organism? Through an analysis of patent law and scientific progress in the development of artificial organ systems, this paper explores the boundaries of patentable subject matter in the United States and attempts to clarify Congress’s determination that “no patent may issue on a claim directed to or encompassing a human organism.” Though patent law should incentivize development of artificial human tissues and organs, Section 33(a) of the AIA stands to limit scientific progress. Either judicial or legislative action must clarify the term “human organism” to balance the need for artificial organ development, while hindering unethical scientific development of artificial humans

Sy-STEM-Ic Bias: An Exploration of Gender and Race Representation on University Patents

People of color and women are underrepresented in science, technology, engineering and math (STEM) fields in the United States. Through both intentional and unintentional structural barriers, universities continue to lose valuable intellectual resources by perpetuating a lack of gender, racial, and ethnic diversity as people climb the academic ladder. Identifying racial and gender disparities between university campus populations and their patent representation quantifies the qualitatively observed systemic racism and sexism plaguing STEM. Without data quantifying the underrepresentation of women and people of color, specifically when protecting their intellectual property rights, universities cannot show that their programs designed to close these gaps are, in fact, effective. This article fills that space by offering a quantitative analysis of the patent gap between white, male inventors, inventors of color, and female inventors at Ivy League institutions, historically Black colleges or universities (HBCUs), research institutions, and other highly ranked universities in the United States. By comparing the racial and gender representation on university patents to the representation at the university, the data can conclusively demonstrate that intellectual property underrepresentation is rampant within a seemingly equalizing environment, where every student and faculty member theoretically has equal access to university funding and legal representation to obtain patents on their intellectual property. Universities and researchers can use this data to determine whether mentorship, outreach, tenure-track, and funding programs implemented to close racial and gender gaps are effective or simply restorative justice theater. Universities are obligated to pursue programs for practical academic equity, rather than false promises of equal opportunity

Assessing treatment outcomes in multiple sclerosis trials and in the clinical setting

Increasing numbers of drugs are being developed for the treatment of multiple sclerosis (MS). Measurement of relevant outcomes is key for assessing the efficacy of new drugs in clinical trials and for monitoring responses to disease-modifying drugs in individual patients. Most outcomes used in trial and clinical settings reflect either clinical or neuroimaging aspects of MS (such as relapse and accrual of disability or the presence of visible inflammation and brain tissue loss, respectively). However, most measures employed in clinical trials to assess treatment effects are not used in routine practice. In clinical trials, the appropriate choice of outcome measures is crucial because the results determine whether a drug is considered effective and therefore worthy of further development; in the clinic, outcome measures can guide treatment decisions, such as choosing a first-line disease-modifying drug or escalating to second-line treatment. This Review discusses clinical, neuroimaging and composite outcome measures for MS, including patient-reported outcome measures, used in both trials and the clinical setting. Its aim is to help clinicians and researchers navigate through the multiple options encountered when choosing an outcome measure. Barriers and limitations that need to be overcome to translate trial outcome measures into the clinical setting are also discussed

Sy-STEM-Ic Bias: An Exploration of Gender and Race Representation on University Patents

People of color and women are underrepresented in science, technology, engineering and math (STEM) fields in the United States. Through both intentional and unintentional structural barriers, universities continue to lose valuable intellectual resources by perpetuating a lack of gender, racial, and ethnic diversity as people climb the academic ladder. Identifying racial and gender disparities between university campus populations and their patent representation quantifies the qualitatively observed systemic racism and sexism plaguing STEM. Without data quantifying the underrepresentation of women and people of color, specifically when protecting their intellectual property rights, universities cannot show that their programs designed to close these gaps are, in fact, effective. This article fills that space by offering a quantitative analysis of the patent gap between white, male inventors, inventors of color, and female inventors at Ivy League institutions, historically Black colleges or universities (HBCUs), research institutions, and other highly ranked universities in the United States. By comparing the racial and gender representation on university patents to the representation at the university, the data can conclusively demonstrate that intellectual property underrepresentation is rampant within a seemingly equalizing environment, where every student and faculty member theoretically has equal access to university funding and legal representation to obtain patents on their intellectual property. Universities and researchers can use this data to determine whether mentorship, outreach, tenure-track, and funding programs implemented to close racial and gender gaps are effective or simply restorative justice theater. Universities are obligated to pursue programs for practical academic equity, rather than false promises of equal opportunity

The Same, but Different: Central Banks, Regulatory Agencies, and the Politics of Delegation to Independent Authorities

Independent regulatory agencies are the institutional foundations of the regulatory state that, during the past 15 years, has gained prominence throughout Europe. This article studies the rise of independent authorities in European countries by comparing regulatory agencies and central banks. Delegation to independent central banks and to independent regulatory agencies is similar in many respects. In both cases, agents are deliberately made independent from political principals through a specific institutional design. Moreover, it has been argued that delegation to both central banks and regulatory agencies is linked to the need for policy-makers to improve the credibility of policy commitments, to the wish of incumbent politicians to tie the hands of future majorities, and to the extent to which the institutional contexts safeguard policy stability. Through an analysis of the formal independence of central banks and regulatory agencies in Western Europe, this article identifies an empirical puzzle that casts doubts on the accuracy of current explanations. Veto players and the uncertainty of incumbent policy-makers in respect to their re-election prospects matter for delegation to both central banks and regulatory agencies, but in opposite ways. Making sense of these anomalies is necessary to achieve a better understanding of delegation to independent authorities

Independent agencies: more than a cheap copy of independent central banks?

Financial supervision, Central banking, Independence, Accountability, Governance, Independent regulatory agencies, Regulatory state, G18, G28, H11,

Study protocol: The Childhood to Adolescence Transition Study (CATS)

Background: Puberty is a multifaceted developmental process that begins in late-childhood with a cascade of endocrine changes that ultimately lead to sexual maturation and reproductive capability. The transition through puberty is marked by an increased risk for the onset of a range of health problems, particularly those related to the control of behaviour and emotion. Early onset puberty is associated with a greater risk of cancers of the reproductive tract and cardiovascular disease. Previous studies have had methodological limitations and have tended to view puberty as a unitary process, with little distinction between adrenarche, gonadarche and linear growth. The Childhood to Adolescence Transition Study (CATS) aims to prospectively examine associations between the timing and stage of the different hormonally-mediated changes, as well as the onset and course of common health and behavioural problems that emerge in the transition from childhood to adolescence. The initial focus of CATS is on adrenarche, the first hormonal process in the pubertal cascade, which begins for most children at around 8 years of age.Methods/Design: CATS is a longitudinal population-based cohort study. All Grade 3 students (8-9 years of age) from a stratified cluster sample of schools in Melbourne, Australia were invited to take part. In total, 1239 students and a parent/guardian were recruited to participate in the study. Measures are repeated annually and comprise student, parent and teacher questionnaires, and student anthropometric measurements. A saliva sample was collected from students at baseline and will be repeated at later waves, with the primary purpose of measuring hormonal indices of adrenarche and gonadarche.Discussion: CATS is uniquely placed to capture biological and phenotypic indices of the pubertal process from its earliest manifestations, together with anthropometric measures and assessment of child health and development. The cohort will provide rich detail of the development, lifestyle, external circumstances and health of children during the transition from childhood through to adolescence. Baseline associations between the hormonal measures and measures of mental health and behaviour will initially be examined cross-sectionally, and then in later waves longitudinally. CATS will make a unique contribution to the understanding of adrenarche and puberty in children's health and development