Who\u27s Afraid of Section 1498? A Case for Government Patent Use in Pandemics and Other National Crisis

COVID-19 has created pressing and widespread needs for vaccines, medical treatments, PPE, and other medical technologies, needs that may conflict--indeed, have already begun to conflict--with the exclusive rights conferred by United States patents. The U.S. government has a legal mechanism to overcome this conflict: government use of patented technologies at the cost of government paid compensation under 28 U. S.C. § 1498. But while many have recognized the theoretical possibility of government patent use under that statute, there is today conventional wisdom that § 1498 is too exceptional, unpredictable, and dramatic for practical use, to the point that it ought to be invoked sparingly or not at all, even in extraordinary circumstances such as a pandemic. Yet that conventional wisdom is a recent one, and it conflicts with both history and theory. This Article considers the role of § 1498 in the context of national crises and emergencies like COVID-19, a context so far not addressed substantially in the literature on the statute. We find that government patent use is not nearly as exceptional as it is commonly made out to be and indeed has been not only used but expanded through statutory amendment over the last century. Review of the development and use of the statute during both world wars and the post-September 11 period reveals widespread acceptance of government patent use as a tool for addressing imminent national problems, and it illuminates particular features of government patent use that become especially pertinent in times of crisis. In the United States, government patent use and national emergencies have a close and special relationship; each has shaped the other. Drawing from the lessons of history and analysis of the statute, we develop a novelframeworkforcomparing§ 1498 to other policy tools, including prizes, research grants, and patent buyouts. Under this framework, four features of § 1498 stand out: speed of invocation, flexibility in the scope of its use, post-crisis determination of compensation, and use of an impartial adjudicator. Whenever these four features are advantageous which will be true in most national emergency situations, as we demonstrate the U.S. government should strongly consider government patent use over patent buyouts and other policy tools. We show the advantages of these four features in a case study: government patent to expand supply and access to the COVID-19 treatment remdesivir. Accordingly, and contrary to the conventional view of § 1498, we conclude that government patent should be an ordinary tool of government polic

Who’s Afraid of Section 1498? A Case for Government Patent Use in Pandemics and Other National Crises

COVID-19 has created pressing and widespread needs for vaccines, medical treatments, PPE, and other medical technologies, needs that may conflict – indeed, have already begun to conflict – with the exclusive rights conferred by United States patents. The U.S. government has a legal mechanism to overcome this conflict: government use of patented technologies at the cost of government-paid compensation under 28 U.S.C. § 1498. But while many have recognized the theoretical possibility of government patent use under that statute, there is today a conventional wisdom that § 1498 is too exceptional, unpredictable, and dramatic for practical use, to the point that it ought to be invoked sparingly or not at all, even in extraordinary circumstances such as a pandemic. Yet that conventional wisdom is a recent one, and it conflicts with both history and theory. This Article considers the role of § 1498 in the context of national crises and emergencies like COVID-19, a context so far not addressed substantially in the literature on the statute. We find that government patent use is not nearly as exceptional as it is commonly made out to be, and indeed has been not only used but expanded through statutory amendment over the last century. Review of the development and use of the statute during both world wars and the post–September 11 period reveals widespread acceptance of government patent use as a tool for addressing imminent national problems, and it illuminates particular features of government patent use that become especially pertinent in times of crisis. In the United States, government patent use and national emergencies have a close and special relationship; each has shaped the other. Drawing from the lessons of history and analysis of the statute, we develop a novel framework for comparing § 1498 to other policy tools, including prizes, research grants, and patent buyouts. Under this framework, four features of § 1498 stand out: speed of invocation, flexibility in the scope of its use, post-crisis determination of compensation, and use of an impartial adjudicator. Whenever these four features are advantageous – which will be true in most national emergency situations, as we demonstrate – the U.S. government should strongly consider government patent use over patent buyouts and other policy tools. We show the advantages of these four features in a case study: government patent use to expand supply and access to the COVID-19 treatment remdesivir. Accordingly, and contrary to the conventional view of § 1498, we conclude that government patent should be an ordinary tool of government policy

Zero-Energy Modes from Coalescing Andreev States in a Two-Dimensional Semiconductor-Superconductor Hybrid Platform

We investigate zero-bias conductance peaks that arise from coalescing subgap Andreev states, consistent with emerging Majorana zero modes, in hybrid semiconductor-superconductor wires defined in a two-dimensional InAs/Al heterostructure using top-down lithography and gating. The measurements indicate a hard superconducting gap, ballistic tunneling contact, and in-plane critical fields up to $3$~T. Top-down lithography allows complex geometries, branched structures, and straightforward scaling to multicomponent devices compared to structures made from assembled nanowires.Comment: Includes Supplementary Materia

An analysis of natural T cell responses to predicted tumor neoepitopes

Personalization of cancer immunotherapies such as therapeutic vaccines and adoptive T-cell therapy may benefit from efficient identification and targeting of patient-specific neoepitopes. However, current neoepitope prediction methods based on sequencing and predictions of epitope processing and presentation result in a low rate of validation, suggesting that the determinants of peptide immunogenicity are not well understood. We gathered published data on human neopeptides originating from single amino acid substitutions for which T cell reactivity had been experimentally tested, including both immunogenic and non-immunogenic neopeptides. Out of 1,948 neopeptide-HLA (human leukocyte antigen) combinations from 13 publications, 53 were reported to elicit a T cell response. From these data, we found an enrichment for responses among peptides of length 9. Even though the peptides had been pre-selected based on presumed likelihood of being immunogenic, we found using NetMHCpan-4.0 that immunogenic neopeptides were predicted to bind significantly more strongly to HLA compared to non-immunogenic peptides. Investigation of the HLA binding strength of the immunogenic peptides revealed that the vast majority (96%) shared very strong predicted binding to HLA and that the binding strength was comparable to that observed for pathogen-derived epitopes. Finally, we found that neopeptide dissimilarity to self is a predictor of immunogenicity in situations where neo- and normal peptides share comparable predicted binding strength. In conclusion, these results suggest new strategies for prioritization of mutated peptides, but new data will be needed to confirm their value.Fil: Bjerregaard, Anne-Mette. Technical University of Denmark; DinamarcaFil: Nielsen, Morten. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata. Instituto de Investigaciones Biotecnológicas. Universidad Nacional de San Martín. Instituto de Investigaciones Biotecnológicas; Argentina. Technical University of Denmark; DinamarcaFil: Jurtz, Vanessa. Technical University of Denmark; DinamarcaFil: Barra, Carolina M.. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata. Instituto de Investigaciones Biotecnológicas. Universidad Nacional de San Martín. Instituto de Investigaciones Biotecnológicas; ArgentinaFil: Hadrup, Sine Reker. Technical University of Denmark; DinamarcaFil: Szallasi, Zoltan. Technical University of Denmark; Dinamarca. Harvard Medical School; Estados UnidosFil: Eklund, Aron Charles. Technical University of Denmark; Dinamarc

Superconducting Gatemon Qubit based on a Proximitized Two-Dimensional Electron Gas

The coherent tunnelling of Cooper pairs across Josephson junctions (JJs) generates a nonlinear inductance that is used extensively in quantum information processors based on superconducting circuits, from setting qubit transition frequencies and interqubit coupling strengths, to the gain of parametric amplifiers for quantum-limited readout. The inductance is either set by tailoring the metal-oxide dimensions of single JJs, or magnetically tuned by parallelizing multiple JJs in superconducting quantum interference devices (SQUIDs) with local current-biased flux lines. JJs based on superconductor-semiconductor hybrids represent a tantalizing all-electric alternative. The gatemon is a recently developed transmon variant which employs locally gated nanowire (NW) superconductor-semiconductor JJs for qubit control. Here, we go beyond proof-of-concept and demonstrate that semiconducting channels etched from a wafer-scale two-dimensional electron gas (2DEG) are a suitable platform for building a scalable gatemon-based quantum computer. We show 2DEG gatemons meet the requirements by performing voltage-controlled single qubit rotations and two-qubit swap operations. We measure qubit coherence times up to ~2 us, limited by dielectric loss in the 2DEG host substrate

Giant spin-orbit splitting in inverted InAs/GaSb double quantum wells

Transport measurements in inverted InAs/GaSb quantum wells reveal a giant spin-orbit splitting of the energy bands close to the hybridization gap. The splitting results from the interplay of electron-hole mixing and spin-orbit coupling, and can exceed the hybridization gap. We experimentally investigate the band splitting as a function of top gate voltage for both electron-like and hole-like states. Unlike conventional, noninverted two-dimensional electron gases, the Fermi energy in InAs/GaSb can cross a single spin-resolved band, resulting in full spin-orbit polarization. In the fully polarized regime we observe exotic transport phenomena such as quantum Hall plateaus evolving in $e^2/h$ steps and a non-trivial Berry phase

Transplantation for metastatic liver disease

The liver is a common site of metastases from many cancers, particularly those originating in the gastrointestinal tract. Liver transplantation is an uncommonly used but promising and at times controversial treatment option for neuroendocrine and colorectal liver metastases. Transplantation with meticulous patient selection has been associated with excellent long-term outcomes in individuals with neuroendocrine liver metastases, but questions remain regarding the role of transplantation in those who could also be eligible for hepatectomy, the role of neoadjuvant/adjuvant treatments in minimising recurrence, and the optimal timing of the procedure. A prospective pilot study of liver transplantation for unresectable colorectal liver metastases that reported a 5-year overall survival rate of 60% reinvigorated interest in this area following initially dismal outcomes. This has been followed by larger studies, and prospective trials are ongoing to quantify the potential benefits of liver transplantation over palliative chemotherapy. This review provides a critical summary of currently available knowledge on liver transplantation for neuroendocrine and colorectal liver metastases, and highlights avenues for further study to address gaps in the evidence base

Use of electronic patient data overview with alerts in primary care increases prescribing of lipid-lowering medications in patients with type 2 diabetes

AIMS/HYPOTHESIS: We aimed to assess whether general practices (GPs) using an electronic disease management program (DMP) with population overviews, including alerts when patients failed to receive guideline-recommended prescription medications, increased prescriptions of lipid-lowering drugs for patients with type 2 diabetes with no history of lipid-lowering treatment. METHODS: This observational study included 165 GPs that reached a high level of use of the DMP in 2012 and a control group of 135 GPs who reached a high level of use in 2013 and, hence, who were less exposed to the DMP throughout 2012. A binary measure for having been prescribed and filled lipid-lowering drugs at any time within a 12-month exposure period was derived for all patients with type 2 diabetes who did not receive a prescription for lipid-lowering drugs in the baseline year prior to the study period (i.e. 2011). Results were derived using ORs from multivariate logistic regression analyses. Subgroup stratification based on age, sex, diabetes duration, deprivation status and Charlson Comorbidity Index (CCI) score was conducted and assessed. Placebo tests were carried out to assess bias from selection to treatment. RESULTS: Patients who did not receive a prescription of lipid-lowering drugs in the year prior to being listed with GPs that used the DMP had statistically significant greater odds of receiving a prescription of lipid-lowering medications when compared with individuals who attended control GPs (OR 1.23 [95% CI 1.09, 1.38]). When the analysis period was shifted back by 2 years, no significant differences in lipid-lowering drug prescription between the two groups were found to occur, which indicates that these results were not driven by selection bias. Subgroup analyses showed that the increase in lipid-lowering drug prescriptions was primarily driven by changes among male participants (OR 1.32 [95% CI 1.12, 1.54]), patients aged 60–70 years (OR 1.40 [95% CI 1.13, 1.74]), patients with a diabetes duration of ≤5 years (OR 1.33 [95% CI 1.13, 1.56]), non-deprived patients (OR 1.25 [95% CI 1.08, 1.45]) and patients without comorbidities (CCI score = 0; OR 1.27 [95% CI 1.11, 1.45]). CONCLUSIONS/INTERPRETATION: Access to population overviews using a DMP with alerts of clinical performance measures with regard to adhering to guideline-recommended prescription of medications can increase GP prescriptions of lipid-lowering drugs. GRAPHICAL ABSTRACT: [Image: see text] SUPPLEMENTARY INFORMATION: The online version contains peer-reviewed but unedited supplementary material available at 10.1007/s00125-021-05598-x