Explaining the ‘Unpredictable’: An Empirical Analysis of U.S. Patent Infringement Awards

Patent infringement awards are commonly thought to be unpredictable, which raises concerns that patents can lead to unjust enrichment and impede the progress of innovation. We investigate the unpredictability of patent damages by conducting a large-scale econometric analysis of award values. We begin by analyzing the outcomes of 340 cases decided in US federal courts between 1995 and 2008 in which infringement was found and damages were awarded. Our data include the amount awarded, along with information about the litigants, case specifics and economic value of the patents-at-issue. Using these data, we construct an econometric model that explains over 75% of the variation in awards. We further conduct in-depth analysis of the key factors affecting award value, via targeted regressions involving selected variables. We find a high degree of significance between award value and ex ante-identifiable factors collectively, and we also identify significant relationships with accepted indicators of patent value. Our findings demonstrate that infringement awards are not systematically unpredictable and, moreover, highlight the critical elements that can be expected to result in larger or smaller awards

Evaluation of the WRF and CHIMERE models for the simulation of PM₂.₅ in large East African urban conurbations

Urban conurbations of East Africa are affected by harmful levels of air pollution. The paucity of local air quality networks and the absence of the capacity to forecast air quality make difficult to quantify the real level of air pollution in this area. The CHIMERE chemistry transport model has been used along with the Weather Research and Forecasting (WRF) meteorological model to run high-spatial-resolution (2 × 2 km) simulations of hourly concentrations of particulate matter with an aerodynamic diameter smaller than 2.5 µm (PM2.5) for three East African urban conurbations: Addis Ababa in Ethiopia, Nairobi in Kenya, and Kampala in Uganda. Two existing emission inventories were combined to test the performance of CHIMERE as an air quality model for a target monthly period in 2017, and the results were compared against observed data from urban, roadside, and rural sites. The results show that the model is able to reproduce hourly and daily temporal variabilities in aerosol concentrations that are close to observed values from urban, roadside, and rural environments. CHIMERE's performance as a tool for managing air quality was also assessed. The analysis demonstrated that, despite the absence of high-resolution data and up-to-date biogenic and anthropogenic emissions, the model was able to reproduce 66 %–99 % of the daily PM2.5 exceedances above the World Health Organization (WHO) 24 h mean PM2.5 guideline (25 µg m−3) in the three cities. An analysis of the 24 h average PM2.5 levels was also carried out for 17 constituencies in the vicinity of Nairobi. This showed that 47 % of the constituencies in the area exhibited a poor Air Quality Index for PM2.5 that was in the unhealthy category for human health, thereby exposing between 10 000 and 30 000 people per square kilometre to harmful levels of air contamination

Do NPEs Matter? Non-Practicing Entities and Patent Litigation Outcomes

It is widely argued that so-called “patent trolls” are corrupting the U.S. patent system and endangering technology innovation and commercialization at large. For example, a recent White House report argued that “trolls” hurt firms of all sizes and advocated for specific policies aimed at curtailing practices thought to be particularly harmful. Yet the existence and extent of any systematic effects of so-called “troll-like” behavior, and the implications of modern patent assertion practices by Non-Practicing Entities (“NPEs”), remains unclear. This article develops novel empirical evidence to inform the debate over NPEs on patent litigation. Specifically, we conduct a large-scale empirical analysis of more than 1,750 patent infringement cases decided by a judge or jury in U.S. district courts between 1995 and 2011. We focus on case outcomes, including findings of validity and infringement, and the distributions and values of resulting damage awards. We find some relatively small differences in terms of lower success rates and award values in cases where the patent holders are NPEs. Yet across the subset of cases in which damages are awarded to the patent holders, we find no significant differences in the distribution of awards between NPEs and practicing entities. Nonetheless, there are substantial differences in litigation behavior, success rates, and award values among types of NPEs (that is, universities, individuals, and Patent Assertion Entities (“PAEs”)). Moreover, we find evidence of certain NPEs engaging in strategic and rational patent acquisition, assertion, and settlement-licensing practices. We posit that these practices may reflect, or perhaps derive from, the economic separation of patent rights from their underlying technologies that is represented in NPE approaches to patent assertion

Patents at Issue: The Data behind the Patent Troll Debate

The debate over patent trolls \u27 is raging at full tilt and its fury is stoked by fundamental questions about patent assertion. Both sides are struggling to understand which patent assertion practices are consistent with the purpose of patent rights and which are abusive and result in net social costs. This Article addresses patent assertion concretely through empirical analysis of actual infringement awards. In particular, this Article studies all awards granted for findings of patent infringement in U.S. district courts between 1995 and 2011, and, with targeted analyses, focuses on cases involving patent assertion entities ( PAEs ). This Article specifically investigates certain principal assumptions about patent assertion which have been raised in the debate and further tests some of the leading policy proposals that are currently being considered. In so doing, this Article seeks to inform the patent troll debate and helps answer some of the key questions driving it. Part I below discusses the background for this study, addressing the current patent troll debate and some of the leading reform proposals that have been advanced. Part H describes the dataset used. Part III explains the empirical methodology used and highlights principal findings from previous work analyzing PAE and other nonpracticing entity ( NPE ) litigations. Part IV investigates PAE assertion practices directly and analyzes key questions that have been raised in the patent troll debate. Part V provides a summary of results and concluding remarks

Holographic Uniformization

We derive and study supergravity BPS flow equations for M5 or D3 branes wrapping a Riemann surface. They take the form of novel geometric flows intrinsically defined on the surface. Their dual field-theoretic interpretation suggests the existence of solutions interpolating between an arbitrary metric in the UV and the constant-curvature metric in the IR. We confirm this conjecture with a rigorous global existence proof.Comment: 52 pages, 3 figure

Long-term efficacy and safety of inotersen for hereditary transthyretin amyloidosis: NEURO-TTR open-label extension 3-year update

© The Author(s) 2022 Open Access This article is licensed under a Creative Commons Attri- bution 4.0 International License, which permits use, sharing, adapta- tion, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/Background: Hereditary transthyretin amyloidosis (hATTR/ATTRv) results from the deposition of misfolded transthyretin (TTR) throughout the body, including peripheral nerves. Inotersen, an antisense oligonucleotide inhibitor of hepatic TTR production, demonstrated a favorable efficacy and safety profile in patients with the polyneuropathy associated with hATTR in the NEURO-TTR (NCT01737398) study. We report longer-term efficacy and safety data for inotersen, with a median treatment exposure of 3 years. Methods: Patients who satisfactorily completed NEURO-TTR were enrolled in its open-label extension (OLE) study. Efficacy assessments included the modified Neuropathy Impairment Score + 7 (mNIS + 7), Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QoL-DN) questionnaire total score, and the Short Form 36 (SF-36v2) Health Survey Physical Component Summary score. Safety and tolerability were also assessed. Efficacy is reported for patients living in Europe and North America (this cohort completed the study approximately 9 months before the remaining group of patients outside these regions); safety is reported for the full safety dataset, comprising patients living in Europe, North America, and Latin America/Australasia. This study is registered with ClinicalTrials.gov, identifier NCT02175004. Results: In the Europe and North America cohort of the NEURO-TTR study, 113/141 patients (80.1%) completed the study, and 109 patients participated in the OLE study. A total of 70 patients continued to receive inotersen (inotersen-inotersen) and 39 switched from placebo to inotersen (placebo-inotersen). The placebo-inotersen group demonstrated sustained improvement in neurological disease progression as measured by mNIS + 7, compared with predicted worsening based on projection of the NEURO-TTR placebo data (estimated natural history). The inotersen-inotersen group demonstrated sustained benefit, as measured by mNIS + 7, Norfolk QoL-DN, and SF-36v2, compared with estimated natural history as well as compared with the placebo-inotersen group. With a maximum exposure of 6.2 years, inotersen was not associated with any additional safety concerns or increased toxicity in the OLE study. Platelet and renal monitoring were effective in reducing the risk of severe adverse events in the OLE study. Conclusion: Inotersen treatment for > 3 years slowed progression of the polyneuropathy associated with hATTR, and no new safety signals were observed.info:eu-repo/semantics/publishedVersio

Analyses of cerebral microdialysis in patients with traumatic brain injury: relations to intracranial pressure, cerebral perfusion pressure and catheter placement

<p>Abstract</p> <p>Background</p> <p>Cerebral microdialysis (MD) is used to monitor local brain chemistry of patients with traumatic brain injury (TBI). Despite an extensive literature on cerebral MD in the clinical setting, it remains unclear how individual levels of real-time MD data are to be interpreted. Intracranial pressure (ICP) and cerebral perfusion pressure (CPP) are important continuous brain monitors in neurointensive care. They are used as surrogate monitors of cerebral blood flow and have an established relation to outcome. The purpose of this study was to investigate the relations between MD parameters and ICP and/or CPP in patients with TBI.</p> <p>Methods</p> <p>Cerebral MD, ICP and CPP were monitored in 90 patients with TBI. Data were extensively analyzed, using over 7,350 samples of complete (hourly) MD data sets (glucose, lactate, pyruvate and glycerol) to seek representations of ICP, CPP and MD that were best correlated. MD catheter positions were located on computed tomography scans as pericontusional or nonpericontusional. MD markers were analyzed for correlations to ICP and CPP using time series regression analysis, mixed effects models and nonlinear (artificial neural networks) computer-based pattern recognition methods.</p> <p>Results</p> <p>Despite much data indicating highly perturbed metabolism, MD shows weak correlations to ICP and CPP. In contrast, the autocorrelation of MD is high for all markers, even at up to 30 future hours. Consequently, subject identity alone explains 52% to 75% of MD marker variance. This indicates that the dominant metabolic processes monitored with MD are long-term, spanning days or longer. In comparison, short-term (differenced or Δ) changes of MD vs. CPP are significantly correlated in pericontusional locations, but with less than 1% explained variance. Moreover, CPP and ICP were significantly related to outcome based on Glasgow Outcome Scale scores, while no significant relations were found between outcome and MD.</p> <p>Conclusions</p> <p>The multitude of highly perturbed local chemistry seen with MD in patients with TBI predominately represents long-term metabolic patterns and is weakly correlated to ICP and CPP. This suggests that disturbances other than pressure and/or flow have a dominant influence on MD levels in patients with TBI.</p

Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial

PURPOSE Antitumor activity in preclinical models and a phase I study of patients with dedifferentiated liposarcoma (DD-LPS) was observed with selinexor. We evaluated the clinical benefit of selinexor in patients with previously treated DD-LPS whose sarcoma progressed on approved agents. METHODS SEAL was a phase II-III, multicenter, randomized, double-blind, placebo-controlled study. Patients age 12 years or older with advanced DD-LPS who had received two-five lines of therapy were randomly assigned (2:1) to selinexor (60 mg) or placebo twice weekly in 6-week cycles (crossover permitted). The primary end point was progression-free survival (PFS). Patients who received at least one dose of study treatment were included for safety analysis (ClinicalTrials.gov identifier: ). RESULTS Two hundred eighty-five patients were enrolled (selinexor, n = 188; placebo, n = 97). PFS was significantly longer with selinexor versus placebo: hazard ratio (HR) 0.70 (95% CI, 0.52 to 0.95; one-sided P = .011; medians 2.8 v 2.1 months), as was time to next treatment: HR 0.50 (95% CI, 0.37 to 0.66; one-sided P < .0001; medians 5.8 v 3.2 months). With crossover, no difference was observed in overall survival. The most common treatment-emergent adverse events of any grade versus grade 3 or 4 with selinexor were nausea (151 [80.7%] v 11 [5.9]), decreased appetite (113 [60.4%] v 14 [7.5%]), and fatigue (96 [51.3%] v 12 [6.4%]). Four (2.1%) and three (3.1%) patients died in the selinexor and placebo arms, respectively. Exploratory RNA sequencing analysis identified that the absence of CALB1 expression was associated with longer PFS with selinexor compared with placebo (median 6.9 v 2.2 months; HR, 0.19; P = .001). CONCLUSION Patients with advanced, refractory DD-LPS showed improved PFS and time to next treatment with selinexor compared with placebo. Supportive care and dose reductions mitigated side effects of selinexor. Prospective validation of CALB1 expression as a predictive biomarker for selinexor in DD-LPS is warranted. (C) 2022 by American Society of Clinical Oncolog

ARFIMA-GARCH modeling of HRV: Clinical application in acute brain injury

In the last decade, several HRV based novel methodologies for describing and assessing heart rate dynamics have been proposed in the literature with the aim of risk assessment. Such methodologies attempt to describe the non-linear and complex characteristics of HRV, and hereby the focus is in two of these characteristics, namely long memory and heteroscedasticity with variance clustering. The ARFIMA-GARCH modeling considered here allows the quantification of long range correlations and time-varying volatility. ARFIMA-GARCH HRV analysis is integrated with multimodal brain monitoring in several acute cerebral phenomena such as intracranial hypertension, decompressive craniectomy and brain death. The results indicate that ARFIMA-GARCH modeling appears to reflect changes in Heart Rate Variability (HRV) dynamics related both with the Acute Brain Injury (ABI) and the medical treatments effects. (c) 2017, Springer International Publishing AG