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Edited by
Daniel Benoliel, University of Haifa, Israel,Peter K. Yu, Texas A & M University School of Law,Francis Gurry, World Intellectual Property Organization,Keun Lee, Seoul National University
Women do not receive their fair share when it comes to patenting and are far less likely to own patents. This disparity is due in part to the inherent biases in science, technology, and the patent system and in part to the high costs of the patent application process. This chapter therefore proposes an unconventional new regime of unregistered patent rights to relieve women and other disadvantaged inventors of such costs and biases and thereby increase their access to patent protections. To explain the proposal, this chapter details the challenges facing women and other disadvantaged inventors in applying for patents as well as the fact that other intellectual property regimes, such as copyright and trademark, allow such unregistered rights. The chapter also addresses a number of objections that the proposal would inevitably raise. In particular, it shows that, because the proposed unregistered patent system would grant rights for only three years and protect only against direct and knowing copying, these rights would be unlikely to deter incremental or complementary innovation. Such rights would also be fully subject to invalidation under a preponderance of the evidence standard.
Edited by
Daniel Benoliel, University of Haifa, Israel,Peter K. Yu, Texas A & M University School of Law,Francis Gurry, World Intellectual Property Organization,Keun Lee, Seoul National University
Theoretically, all inventions are equal under the law: they receive the same scope of protection for the same period, backed by the same remedies. In reality, such equality has been strongly compromised. Patents are concentrated in the hands of big companies and privileged individuals. Women and minorities – as well as firms they own – are less likely to file for patents and have their patents granted. Small companies are also less likely to file and receive patents than strong incumbents. This chapter argues that some changes in the patent system can trigger better accessibility, affordability, and equality. It builds on the author’s earlier proposal to replace the patent record with a decentralized database that would include more information about inventions from more sources and additional functions. Under the proposal, inventors would submit patent applications to a shared patent record instead of a central patent office. During the examination process and throughout the duration of the patent, industry and state actors would be able to update the record. For example, third parties could submit prior art, scientists could weigh in on obviousness, patentees could offer licenses, and courts could list outstanding cases that pertain to the patent.
Videogames once seemed like they would have a part to play in the future of the book – the natural evolution of literary practice onto more expressly interactive digital platforms. Today, despite numerous compelling examples of videogames that support literary engagement, the comparison can seem strange, clichéd, banal, and beside the point. This chapter attempts to reset the comparison of videogames and literature for the present moment of digital culture. First, it presents a brief history of critical perspectives on videogames as literature. Second, it reflects on the contemporary status of and challenges to videogaming’s literary aspirations following recent shifts in the industry’s design priorities and monetization practices. This chapter does not present an argument regarding the status of games as literature. Rather, its goal is to describe the urgent work of literary studies in continuing to rethink digital gaming in the unfolding digital age.
Commercialization is the process of bringing diagnostics from the laboratory setting to the commercial market. Rapid Acceleration of Diagnostics (RADx®) portfolio companies were tasked with developing and producing millions of rapid, accurate, low-cost, and convenient COVID-19 tests to meet surging demand, but tests only help if people can access them. Many would-be purchasers discovered that tests alone would not solve the problem – they needed comprehensive testing solutions. In this chapter, we discuss RADx’s role in assisting portfolio companies in understanding customers’ evolving needs; the shifting market dynamics with each new wave, vaccine, or variant; and the barriers and opportunities to market success. We highlight go-to-market strategies and policy decisions that worked well and we outline policy and regulatory barriers that hindered broader success. We reflect on the lessons learned and potential solutions to adopt before the next pandemic and in the broader context of the future diagnostic delivery system.
During the Tokugawa period, commoners developed increasingly sophisticated methods of challenging what they perceived as unjust government policies or unethical behavior by the wealthy. Popular movements coalesced around petitions that stated grievances. They typically took the form of mass demonstrations that required preparation, organization, and leadership. Even urban food riots had a logic to them. In many cases, they erupted after women had called on merchants to feed the poor, and they followed a code for conduct that cautioned against stealing. In the early nineteenth century, farmers created village leagues that employed representatives to manage issues with regional implications and make their case for commercial policies. In some instances, they argued that all human beings are equal, an argument made unsuccessfully by outcaste villagers. Villagers commemorated popular movements in chronicles and tales, mixing fact and fiction in the interests of a good story, and they remembered their fallen leaders in memorial services.
This chapter maps the effects of war on economies and on women’s work. First, it surveys the role of women both as an official and unofficial part of armies and other military support operations. Second, it looks at the way that military conscription of young men affected the work of women who stayed home, especially given that many of these men would never return or would return unfit for work. Third, it examines the strain that armies, whether engaged in hostilities or simply passing through a region, placed on the local resource base and the way this affected the structure of work, including, at times, amplifying its coercive character. Fourth, war encouraged women in garrison and port towns to engage in new forms of commercialized service work, while giving rise to a large body of people, including many women, to which the state owed wages or pensions. Finally, war generally went along with rising taxes, most often upon commodities and often on staples, such as salt. One result was a sharp increase in smuggling, which, in turn, altered both women’s and men’s relationship to consumption and to the State.
The neurotechnology sector is likely to develop under pressure towards commercialized, nonmedical products and may also undergo market consolidation. This possibility raises ethical, social, and policy concerns about the future responsibility of neurotechnology innovators and companies for high-consequence design decisions. Present-day internet technology firms furnish an instructive example of the problems that arise when providers of communicative technologies become too big for accountability. As a guardrail against the emergence of similar problems, concerned neurotechnologists may wish to draw inspiration from antitrust law and direct efforts, where appropriate, against undue consolidation in the commercial neurotechnology market.
Chapter 9 is about how public institutions contribute to the trajectory of progress. The most common methods for public involvement are through creating institutions (universities, research facilities, etc.) and through distributing grants. There are any number of combinations by which governments and public institutions can give out grants, with each country having their own unique variation. These mechanisms are crucial in determining the rate and direction of progress. By supporting certain research areas, we commit to making progress in one area while potentially reducing it in others. The chapter is also concerned with how public funding differs from private funding, how important public funding is in steering the direction of research towards areas directly relevant to the common person, and how public funding has become more commercialized.
A growing number of biomedical doctoral graduates are entering the biotechnology and industry workforce, though most lack training in business practice. Entrepreneurs can benefit from venture creation and commercialization training that is largely absent from standard biomedical educational curricula. The NYU Biomedical Entrepreneurship Educational Program (BEEP) seeks to fill this training gap to prepare and motivate biomedical entrepreneurs to develop an entrepreneurial skill set, thus accelerating the pace of innovation in technology and business ventures.
Methods:
The NYU BEEP Model was developed and implemented with funding from NIDDK and NCATS. The program consists of a core introductory course, topic-based interdisciplinary workshops, venture challenges, on-line modules, and mentorship from experts. Here, we evaluate the efficacy of the core, introductory course, “Foundations of Biomedical Startups,” through the use of pre/post-course surveys and free-response answers.
Results:
After 2 years, 153 participants (26% doctoral students, 23% post-doctoral PhDs, 20% faculty, 16% research staff, 15% other) have completed the course. Evaluation data show self-assessed knowledge gain in all domains. The percentage of students rating themselves as either “competent” or “on the way to being an expert” in all areas was significantly higher post-course (P < 0.05). In each content area, the percentages of participants rating themselves as “very interested” increased post-course. 95% of those surveyed reported the course met its objectives, and 95% reported a higher likelihood of pursuing commercialization of discoveries post-course.
Conclusion:
NYU BEEP can serve as a model to develop similar curricula/programs to enhance entrepreneurial activity of early-stage researchers.
Transform your research into commercial biomedical products with this revised and updated second edition. Covering drugs, devices and diagnostics, this book provides a step-by-step introduction to the process of commercialization, and will allow you to create a realistic business plan to develop your ideas into approved biomedical technologies. This new edition includes: Over 25% new material, including practical tips on startup creation from experienced entrepreneurs. Tools for starting, growing and managing a new venture, including business planning and commercial strategy, pitching investors, and managing operations.Global real-world case studies, including emerging technologies such as regulated medical software and Artificial Intelligence (AI), offer insights into key challenges and help illustrate complex points. Tips and operational tools from established industry insiders, suitable for graduate students and new biomedical entrepreneurs.
Drug discovery and development is a long and arduous process and is particularly challenging for Alzheimer’s disease given the incomplete understanding of molecular mechanisms, variability in clinical presentation, relatively slow disease progression, and heterogeneous patient population. The lack of predictive preclinical models combined with the long and expensive clinical trials raise additional barriers to therapeutic development. Tens of thousands of academic publications identify potential biomarkers, molecular mechanisms, preclinical models, and interventions, yet very few have led to industry-sponsored drug development programs. In this chapter, we will describe one academic program’s approach to bridging the “valley of death.” The Stanford University SPARK Program helps academics advance their projects through the applied science stage of development, reducing the risk to potential industry partners. SPARK uses simple and easily replicated principles to ensure that more academic discoveries find their way to impact patients and to benefit society. Approximately 60% of SPARK projects advance to industry partnerships or directly into university-sponsored clinical trials.
This conclusion reviews changing practices and habits of gambling in Britain in the long eighteenth century, among different groups in society, and among women and men. The rise in female gambling of different kinds was one of the most striking developments of this period, attracting significant comment from the contemporary press and writers, as well as anxiety from authors of the myriad conduct books of the period. The implications of these changes and of the prevalence of different forms of gambling for our understanding of Britain in this period is examined, in particular in relation to debates among historians about the impact and influence of polite values and culture. The final section of the conclusion looks briefly ahead to the new worlds of gambling as they began to develop in the opening decades of the nineteenth century.
This chapter goes in search of the gambling habits and propensities of the bulk of the population, but does so by focusing in the first place on the gambling of the lower orders and many among the middling sorts in the giant British capital. Through examination of a range of activities, including cricket and lottery insurance, and different gambling locales, it seeks to map the sheer extent and diversity of gambling at this level of society in eighteenth-century London. If London in this period was a ‘gambler’s paradise’, as one historian has claimed, then this was about much more than its exclusive gambling clubs. The final section of the chapter focuses on one activity which became very closely identified with betting in the later Georgian era, and across Britain – pedestrianism, or foot-racing. Through exploring the development and appeal of this sport, it seeks to plot a path forwards from the eighteenth century into the world of early to mid nineteenth century popular sport and betting, in which the centre of gravity moved decisively away from London and to the rapidly growing industrial regions and towns of north and midlands, as well as the manufacturing regions of lowland Scotland.
For over two millennia, China has sustained the largest single human society on the planet through the development of one of the most sophisticated agrarian systems in history. Even until quite recent, agriculture occupied a central place in the Chinese economy, commanding a dominant 60 to 70 percent of the total economy throughout. Agricultural institutions define the Chinese economic system and agricultural production drove long-run economic change or growth in China. Agriculture was at the center of the Great Divergence debate. Agricultural harvest or failures sometimes spelled the rise and fall of dynasties throughout history. Moving to the modern era, Chinese agriculture became the scapegoat for China’s modernization failure and was regarded as the incubator for Communist revolution. However, given its overriding importance, research on modern Chinese agriculture has been surprisingly understudied for the last few decades.
The last 50 years have seen an increasing dependence on academic institutions to develop and commercialize new biomedical innovations, a responsibility for which many universities are ill-equipped. To address this need, we created LEAP, an asset development and gap fund program at Washington University in St. Louis (WUSTL). Beyond awarding funds to promising projects, this program aimed to promote a culture of academic entrepreneurship, and thus improve WUSTL technology transfer, by providing university inventors with individualized consulting and industry expert feedback. The purpose of this work is to document the structure of the LEAP program and evaluate its impact on the WUSTL entrepreneurial ecosystem. Our analysis utilizes program data, participant surveys, and WUSTL technology transfer office records to demonstrate that LEAP consistently attracted new investigators and that the training provided by the program was both impactful and highly valued by participants. We also show that an increase in annual WUSTL start-up formation during the years after LEAP was established and implicate the program in this increase. Taken together, our results illustrate that programs like LEAP could serve as a model for other institutions that seek to support academic entrepreneurship initiatives.
The National Institutes of Health launched the NIH Centers for Accelerated Innovation and the Research Evaluation and Commercialization Hubs programs to develop approaches and strategies to promote academic entrepreneurship and translate research discoveries into products and tools to help patients. The two programs collectively funded 11 sites at individual research institutions or consortia of institutions around the United States. Sites provided funding, project management, and coaching to funded investigators and commercialization education programs open to their research communities.
Methods:
We implemented an evaluation program that included longitudinal tracking of funded technology development projects and commercialization outcomes; interviews with site teams, funded investigators, and relevant institutional and innovation ecosystem stakeholders and analysis and review of administrative data.
Results:
As of May 2021, interim results for 366 funded projects show that technologies have received nearly $1.7 billion in follow-on funding to-date. There were 88 start-ups formed, a 40% Small Business Innovation Research/Small Business Technology Transfer application success rate, and 17 licenses with small and large businesses. Twelve technologies are currently in clinical testing and three are on the market.
Conclusions:
Best practices used by the sites included leadership teams using milestone-based project management, external advisory boards that evaluated funding applications for commercial merit as well as scientific, sustained engagement with the academic community about commercialization in an effort to shift attitudes about commercialization, application processes synced with education programs, and the provision of project managers with private-sector product development expertise to coach funded investigators.
Although most research universities offer investigators help in obtaining patents for inventions, investigators generally have few resources for scaling up non-patentable innovations, such as health behavior change interventions. In 2017, the dissemination and implementation (D & I) team at the University of Wisconsin’s Clinical and Translational Science Award (CTSA) created the Evidence-to-Implementation (E2I) award to encourage the scale-up of proven, non-patentable health interventions. The award was intended to give investigators financial support and business expertise to prepare evidence-based interventions for scale-up.
Methods:
The D & I team adapted a set of criteria named Critical Factors Assessment, which has proven effective in predicting the success of entrepreneurial ventures outside the health care environment, to use as review criteria for the program. In March 2018 and February 2020, multidisciplinary panels assessed proposals using a review process loosely based on the one used by the NIH for grant proposals, replacing the traditional NIH scoring criteria with the eight predictive factors included in Critical Factors Assessment.
Results:
two applications in 2018 and three applications in 2020 earned awards. Funding has ended for the first two awardees, and both innovations have advanced successfully.
Conclusion:
Late-stage translation, though often overlooked by the academic community, is essential to maximizing the overall impact of the science generated by CTSAs. The Evidence-to-implementation award provides a working model for supporting late-stage translation within a CTSA environment.
In 1700 the Mughals controlled much of the Indian subcontinent. By 1858 the British Crown ruled. Why did this transition occur? How did the relationship between the state and economic activity change? And how did the economy perform? This chapter provides an overview, discussing competing perspectives on the breakdown of the Mughal Empire, the rise of the East India Company, the increasing commercialization of the economy, and changes in the economic structure. The literature suggests that the East India Company’s political and military success partly came from more successful fiscal administration compared to its Indian rivals. After consolidating its rule, British policy favoured the export of Indian primary products and the import of manufactured goods, contributing to deindustrialization. In agriculture, the area cultivated increased with population, but technology stagnated. Per capita income, which was already low, may have fallen slightly. Conflicts between the state and local users of forests and other resources emerged, especially in conjunction with the introduction of a major technological innovation, the railways. Our period ends with the Mutiny, a formidable challenge to British rule, following which British policy became conservative, seeking to preserve the existing social order.
Commercializing biomedical discoveries is a challenging process for many reasons. However, Academic Medical Centers (AMC) that have teaching, patient care, research, and service engrained in their mission are well poised to host these discoveries. These academic discoveries can lead to improvement in patient health and economic development if supported to cross the “valley of death” through institutional assistance, by providing guidance, gap funding and product development expertise. Colorado has a vibrant local startup ecosystem, state support for commercialization and entrepreneurship as well as critical mass of product development expertise. University of Colorado Anschutz Medical Campus, as a major AMC, is an engine for growth for the region. This article discusses innovation efforts at the University of Colorado Anschutz Medical Campus as a case study, which is built around two major efforts: the CCTSI and CU Innovations. I-Corps at CCTSI and the SPARK|REACH program of CU Innovations have been instrumental in fostering innovation, commercialization, and entrepreneurship on the campus.