Prospect patents, data markets, and the commons in data-driven medicine : openness and the political economy of intellectual property rights

Scholars who point to political influences and the regulatory function of patent courts in the USA have long questioned the courts’ subjective interpretation of what ‘things’ can be claimed as inventions. The present article sheds light on a different but related facet: the role of the courts in regulating knowledge production. I argue that the recent cases decided by the US Supreme Court and the Federal Circuit, which made diagnostics and software very difficult to patent and which attracted criticism for a wealth of different reasons, are fine case studies of the current debate over the proper role of the state in regulating the marketplace and knowledge production in the emerging information economy. The article explains that these patents are prospect patents that may be used by a monopolist to collect data that everybody else needs in order to compete effectively. As such, they raise familiar concerns about failure of coordination emerging as a result of a monopolist controlling a resource such as datasets that others need and cannot replicate. In effect, the courts regulated the market, primarily focusing on ensuring the free flow of data in the emerging marketplace very much in the spirit of the ‘free the data’ language in various policy initiatives, yet at the same time with an eye to boost downstream innovation. In doing so, these decisions essentially endorse practices of personal information processing which constitute a new type of public domain: a source of raw materials which are there for the taking and which have become most important inputs to commercial activity. From this vantage point of view, the legal interpretation of the private and the shared legitimizes a model of data extraction from individuals, the raw material of information capitalism, that will fuel the next generation of data-intensive therapeutics in the field of data-driven medicine

The Rhetoric of Surveillance in Post-Snowden Background Investigation Policy Reform

abstract: In June 2013, United States (US) government contractor Edward Snowden arranged for journalists at The Guardian to release classified information detailing US government surveillance programs. While this release caused the public to decry the scope and privacy concerns of these surveillance systems, Snowden's actions also caused the US Congress to critique how Snowden got a security clearance allowing him access to sensitive information in the first place. Using Snowden's actions as a kairotic moment, this study examined congressional policy documents through a qualitative content analysis to identify what Congress suggested could “fix” in the background investigation (BI) process. The study then looked at the same documents to problematize these “solutions” through the terministic screen of surveillance studies. By doing this interdisciplinary rhetorical analysis, the study showed that while Congress encouraged more oversight, standardization, and monitoring for selected steps of the BI process, these suggestions are not neutral solutions without larger implications; they are value-laden choices which have consequences for matters of both national security and social justice. Further, this study illustrates the value of incorporating surveillance as framework in rhetoric, composition, and professional/technical communication research.Dissertation/ThesisDoctoral Dissertation English 201

Manufacturing Barriers to Biologics Competition and Innovation

As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. In this Article, we provide a fresh diagnosis of, and prescription for, this major public policy problem. We argue that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of FDA regulation, not only creates high barriers to entry of indefinite duration but also undermines efforts to advance fundamental knowledge. In sharp contrast, offering incentives for information disclosure to originator manufacturers would leverage the existing interaction of trade secrecy and the regulatory state in a positive direction. Although trade secrecy, particularly in complex areas like biologics manufacturing, often involves tacit knowledge that is difficult to codify and thus transfer, in this case regulatory requirements that originator manufacturers submit manufacturing details have already codified the relevant tacit knowledge. Incentivizing disclosure of these regulatory submissions would not only spur competition but it would provide a rich source of information upon which additional research, including fundamental research into the science of manufacturing, could build. In addition to provide fresh diagnosis and prescription in the specific area of biologics, the Article contributes to more general scholarship on trade secrecy and tacit knowledge. Prior scholarship has neglected the extent to which regulation can turn tacit knowledge not only into codified knowledge but into precisely the type of codified knowledge that is most likely to be useful and accurate. The Article also draws a link to the literature on adaptive regulation, arguing that greater regulatory flexibility is necessary and that more fundamental knowledge should spur flexibility. A vastly shortened version of the central argument that manufacturing trade secrecy hampers biosimilar development was published at 348 Science 188 (2015), available online

Redescribing Health Privacy: The Importance of Health Policy

Current conversations about health information policy often tend to be based on three broad assumptions. First, many perceive a tension between regulation and innovation. We often hear that privacy regulations are keeping researchers, companies, and providers from aggregating the data they need to promote innovation. Second, aggregation of fragmented data is seen as a threat to its proper regulation, creating the risk of breaches and other misuse. Third, a prime directive for technicians and policymakers is to give patients ever more granular methods of control over data. This article questions and complicates those assumptions, which I deem (respectively) the Privacy Threat to Research, the Aggregation Threat to Privacy, and the Control Solution. This article is also intended to enrich our concepts of “fragmentation” and “integration” in health care. There is a good deal of sloganeering around “firewalls” and “vertical integration” as idealized implementations of “fragmentation” and “integration” (respective). The problem, though, is that terms like these (as well as “disruption”) are insufficiently normative to guide large-scale health system change. They describe, but they do not adequately prescribe. By examining those instances where: a) regulation promotes innovation, and b) increasing (some kinds of) availability of data actually enhances security, confidentiality, and privacy protections, this article attempts to give a richer account of the ethics of fragmentation and integration in the U.S. health care system. But, it also has a darker side, highlighting the inevitable conflicts of values created in a “reputation society” driven by stigmatizing social sorting systems. Personal data control may exacerbate social inequalities. Data aggregation may increase both our powers of research and our vulnerability to breach. The health data policymaking landscape of the next decade will feature a series of intractable conflicts between these important social values

Economic Fundamentals Of the Knowledge Society

This article provides an introduction to fundamental issues in the development of new knowledge-based economies. After placing their emergence in historical perspective and proposing a theoretical framework that distinguishes knowledge from information, the authors characterize the specific nature of such economies. They go on to deal with some of the major issues concerning the new skills and abilities required for integration into the knowledge-based economy; the new geography that is taking shape (where physical distance ceases to be such an influential constraint); the conditions governing access to both information and knowledge, not least for developing countries; the uneven development of scientific, technological (including organizational) knowledge across different sectors of activity; problems concerning intellectual property rights and the privatization of knowledge; and the issues of trust, memory and the fragmentation of knowledge. This monograph is concerned with the nature of the process of macroeconomic growth that has characterized the U. S. experience, and manifested itself in the changing pace and sources of the continuing rise real output per capita over the course of the past two hundred years. A key observation that emerges from the long-term quantitative economic record is that the proximate sources of increases in real GDP per head in the century between 1889 and 1999 were quite different from those which obtained during the first hundred years of American national experience. Baldly put, the economy's ascent to a position of twentieth century global industrial leadership entailed a transition from growth based upon the interdependent development and extensive exploitation of its natural resources and the substitution of tangible capital for labor, towards a the maintenance of an productivity leadership through rising rates of intangible investment in the formation and exploitation of technological and organizational knowledge.