Improving equity in patent inventorship.

Expanding who gets credit for invention may boost participation in innovation.

The NBER Orange Book Dataset: A user's guide.

This paper introduces a newly digitized, open-access version of the Food and Drug Administration's "Orange Book"-a linkage between approved small-molecule drugs and the patents that protect them. The Orange Book also reports any applicable regulatory exclusivity that prevents competitive entry. We summarize the Orange Book's coverage and discuss the opportunities and challenges associated with using these data for research. Empirical validations against various administrative datasets suggest that Orange Book records are, largely, complete and accurate. We conclude with a specific use case-calculating legal exclusivity periods for drugs-to highlight the types of choices that researchers must make when using this resource.

Rationally designed bacterial consortia to treat chronic immune-mediated colitis and restore intestinal homeostasis.

Environmental factors, mucosal permeability and defective immunoregulation drive overactive immunity to a subset of resident intestinal bacteria that mediate multiple inflammatory conditions. GUT-103 and GUT-108, live biotherapeutic products rationally designed to complement missing or underrepresented functions in the dysbiotic microbiome of IBD patients, address upstream targets, rather than targeting a single cytokine to block downstream inflammation responses. GUT-103, composed of 17 strains that synergistically provide protective and sustained engraftment in the IBD inflammatory environment, prevented and treated chronic immune-mediated colitis. Therapeutic application of GUT-108 reversed established colitis in a humanized chronic T cell-mediated mouse model. It decreased pathobionts while expanding resident protective bacteria; produced metabolites promoting mucosal healing and immunoregulatory responses; decreased inflammatory cytokines and Th-1 and Th-17 cells; and induced interleukin-10-producing colonic regulatory cells, and IL-10-independent homeostatic pathways. We propose GUT-108 for treating and preventing relapse for IBD and other inflammatory conditions characterized by unbalanced microbiota and mucosal permeability.

Innovation policy and the market for vaccines.

Vaccines play a crucial role in improving global public health, with the ability to stem the spread of infectious diseases and the potential to eradicate them completely. Compared with pharmaceuticals that treat disease, however, preventative vaccines have received less attention from both biomedical researchers and innovation scholars. This neglect has substantial human and financial costs, as vividly illustrated by the COVID-19 pandemic. In this article, we argue that the large number of ``missing'' vaccines is likely due to more than lack of scientific opportunities. Two key aspects of vaccines help account for their anemic development pipeline: (1) they are preventatives rather than treatments; and (2) they are generally durable goods with long-term effects rather than products purchased repeatedly. We explain how both aspects make vaccines less profitable than repeat-purchase treatments, even given comparable IP protection. We conclude by arguing that innovation policy should address these market distortions by experimenting with larger government-set rewards for vaccine production and use. Most modestly, policymakers should increase direct funding-including no grants and public-private partnerships-and insurance-based market subsidies for vaccine development. We also make the case for a large cash prize for any new vaccine made available at low or zero cost.

Innovation institutions and the opioid crisis.

The US has recently-and belatedly-come to recognize opioid addiction as a public health crisis. What has gone mostly unrecognized is the degree to which this crisis is intertwined with US intellectual property law and related elements of US innovation policy. Innovation institutions-the legal arrangements that structure incentives for production and allocation of knowledge goods-encouraged the development and commercialization of addictive painkillers, restricted access to opioid antidotes, and (perhaps most importantly) failed to facilitate investments in alternative, nonaddictive treatments for chronic pain. Although innovation policy does not bear all the blame for the opioid wave that has washed over communities across the country, innovation institutions are bound up in the ongoing epidemic to a degree that so far has gone underappreciated. This article examines the proliferation of opioid use and abuse through the lens of innovation policy, and it envisions ways in which innovation institutions could help to contain the crisis. Along the way, it seeks to derive broader lessons for innovation policy scholarship as well as recommendations for institutional reform. The opioid crisis challenges the conventional understanding of IP law as a trade-off between allocative efficiency and dynamic efficiency; it highlights the potentially pernicious role of IP protection for addictive and habit-forming products; and it exposes deep flaws in the structure of federal subsidies for and regulation of prescription drugs. It also draws attention to the political and cultural factors that contribute to innovation policy failures. Ultimately, the opioid crisis underscores both the urgency and the limits of institutional change in the innovation policy domain.

LinkageMapView-rendering high-resolution linkage and QTL maps.

MOTIVATION: Linkage and quantitative trait loci (QTL) maps are critical tools for the study of the genetic basis of complex traits. With the advances in sequencing technology over the past decade, linkage map densities have been increasing dramatically, while the visualization tools have not kept pace. LinkageMapView is a free add-on package written in R that produces high resolution, publication-ready visualizations of linkage and QTL maps. While there is software available to generate linkage map graphics, none are freely available, produce publication quality figures, are open source and can run on all platforms. LinkageMapView can be integrated into map building pipelines as it seamlessly incorporates output from R/qtl and also accepts simple text or comma delimited files. There are numerous options within the package to build highly customizable maps, allow for linkage group comparisons, and annotate QTL regions. AVAILABILITY AND IMPLEMENTATION: https://cran.r-project.org/web/packages/LinkageMapView/.