The beginning of university entrepreneurship in Japan: TLOs and bioventures lead the way

Following reforms between 1998 and 2004, Japan’s technology transfer system closely resembles the U.S. Bayh-Dole system. Numbers of TLO patents and licenses and numbers of startups are respectable compared to U.S. numbers shortly after enactment of Bayh-Dole. However, capabilities of TLOs vary, average royalties are low, and business prospects for most startups seem limited. In contrast, joint research with companies is increasing rapidly. Most joint research inventions are jointly owned giving the companies an automatic de facto, non-transferable, royalty-free and license. Data from one university show a large proportion of engineering and materials/chemistry inventions are attributed to joint research with large companies, thus limiting opportunities for startup formation and licensing to other small companies. (In biomedicine, pre-emption of discoveries by joint research is less.) Pre-emption of university discoveries (often publicly funded) under joint research agreements recreates the pre-reform system, where corporate donations also enabled pre-emption of discoveries. Like the old system, the new system is advantageous to established companies. Strengthening the formal system (including programs to assist startups) may redress this balance and give Japan the benefits of both types of technology transfer systems.

Scientist entrepreneurship across scientific fields

Knowledge generated in universities can serve as an important base for the commercialization of innovation. One mechanism for commercialization is the creation of a new company by a scientist. We shed light on this process by examining the role of scientist characteristics, access to resources and key university conditions in driving the likelihood of a scientist to start a company. Our sample comprises 1,899 university scientists across six different scientific fields. We make a methodological contribution by using self-reported data from the scientists themselves, whereas most previous research relied on university or public data. Our consideration of six scientific fields is a substantive contribution and reveals that scientist startups are heterogeneous in nature. Our findings are largely consistent with extant research on the role of individual and university variables in scientist entrepreneurship; in addition, we uncover the novel finding that the type of research field is also a key driver of scientist startup activity.     

Closing the divide: accelerating technology commercialization by catalyzing the university entrepreneurial ecosystem with I-Corps™

In recent years, universities have seen an increasing amount of activity in entrepreneurship and commercialization, not only for students, but for faculty as well. Traditionally, these initiatives have been separate, such that programs and curriculum have been focused on supporting just students or just faculty. In 2012, the National Science Foundation (NSF) launched the NSF I-Corps? program, an innovative funding program that not only offered principle investigators (PIs) funding, but also exposed PIs to an innovation/entrepreneurship curriculum as well. The University of Michigan (U-M) was one of the first two NSF I-Corps? Nodes funded in 2012 and has leveraged the program to catalyze the entrepreneurial ecosystem. This paper describes the growth of this entrepreneurial ecosystem since 1983, the call of entrepreneurship in the U-M College of Engineering and describes the role the U-M NSF I-Corps? program has played across the university. The paper concludes with lessons learned and recommendations to administrators and policy makers considering more active promotion of academic entrepreneurship and commercialization in universities.     

Technology commercialization: a literature review of success factors and antecedents across different contexts

This paper provides a systematic review of the current literature on technology commercialization. It serves to establish a foundation for the following empirical and theoretical contributions. Technological inventions are fundamental for a country’s economic growth. However, in order to actually generate value for society and profits for the involved companies, these inventions need to be successfully transferred to the market. Therefore, newly developed technologies need to be integrated into products which sell. In particular, our study focuses on the different interaction channels through which technology commercialization occurs. We analyze main groups of institutions, which can either act as developers of technologies and/or organizations bringing these technologies to the market: Universities and research institutes, technology startups, and established companies. We propose a theoretical framework of possible interactions between these organizations and analyze the success factors within the respective channels. Based on the systematic review of 140 articles, key characteristics of the technology development organizations are analyzed with regard to the different possible channels available to commercialize their technology.     

Why university inventions rarely produce income? Bottlenecks in university technology transfer

As intended, universities have gained ownership to an increased number of inventions from their labs after the enactment of Bayh-Dole act in 1980. But, how well are the universities taking advantage of the provisions of this Act? One aspect of this question is addressed empirically in this study. An analysis of the Association of University Technology Managers (AUTM) periodic Licensing Activity Surveys of 1995–2004 indicated that the annual income generated by licensing university inventions was 1.7% of total research expenditure in 1995 and 2.9% in 2004. Some consider this and the rate of commercialization of university inventions to be too low. A premise of this study is that the slow rate of commercialization of university inventions may be due to the lack of adequate trained staff and inventions processing capacity in University Offices of Technology Transfer (UOTT). This paper describes an empirical study of the non-legal, technical, and legal invention processing capacity of US UOTT and its implications. A survey questionnaire was sent to 99 randomly selected US research universities. Seventy-five percent of the respondents mentioned shortage of staff for non-legal and legal processing of inventions. More than a third of the respondents claimed that, in 2006, they failed to process more than 26% of the inventions due to insufficient processing capacity in the UOTT. The study includes multiple regression models to estimate the effect of staffing on performance variables (i.e., Provisional Applications Filed, Patent [non-provisional] Applications and Licenses Executed) and “Inventions Not Processed” by the UOTTs due to staff/budget shortages. It is argued that, when short of staff and budget, UOTTs will be reduced to devoting their resources to ensuring patent applications are filed and patents are issued at the expense of marketing of inventions. Further, high-tech inventions are difficult to market because, often, there are no ready markets for them, especially if the inventor had no pre-invention contacts with a potential licensee. High-tech inventions originating from university labs may need market space/niche identification, new market creation, and the translation of the lab result into an “investor friendly” business plan; most UOTTs may be significantly short on these skills. Recommendations of this study are: first, an in-depth study of universities that are prolific in licensing inventions (40 or more licenses a year) is necessary to understand the reasons for their success in the context of UOTTs capacity to process inventions. Further, all federal agencies sponsoring university research must earmark a small percentage of each grant exclusively for commercialization purposes at the university. The paper offers multiple options for the effective use of these funds. The paper also offers several avenues for future research.     

A policy for enhancing the disclosure of university faculty invention

Faculty scientists often avoid disclosing their inventions to the university’s technology licensing office (TLO), opting instead to self-license their invention. As this paper argues, TLO’s can achieve full disclosure by allowing faculty scientists to self-license their invention in return for some form of non-pecuniary “insurance”, just in case they fail in self-licensing their technology.     

Managing and incentivizing research commercialization in Chinese Universities

Research shows that there are important institutional underpinnings for building university–industry linkages. This paper aims to understand how China is developing the relevant organizational structures and incentives in its universities. What academic institutions shape the scope and channels of university–industry linkages? What incentives do universities provide to encourage and facilitate faculty engagement with industry? My analysis is accomplished through content analysis of university documents and in-depth interviews with personnel in two top institutions—Fudan University and Shanghai Jiaotong University, supplemented by official statistics. It shows that the hybrid organizational structure to manage technology transfer is a product of historical legacy and institutional learning—parts uniquely Chinese and parts adapted from the West. Faculty incentives also have varied effects. In spite of being enticed to disclose inventions and pursue commercialization, faculty remains keener on scholarly publications.     

University technology transfer through entrepreneurship: faculty and students in spinoffs

This research informs our understanding of the technology commercialization process in university spinoffs, focusing in particular on student involvement in the early phases of the spinoff development process and on the impact of the larger university ecosystem. Detailed case studies indicate that graduate and post-doctoral students are important participants in university spinoffs. We offer a typology of spinoff development with four pathways, based on the varying roles of faculty, experienced entrepreneurs, PhD/post-doctoral students, and business students. The effects of the larger university ecosystem, beyond the university technology transfer office and the university’s commercialization policies, are also considered, including an examination of programs and practices that may influence this process. We close with a discussion of guidelines for technology transfer and spinoff development at universities, based on the findings of this research.     

The mouse that trolled: the long and tortuous history of a gene mutation patent that became an expensive impediment to Alzheimer's research

This case study presents the tale of the academic discovery of a rare mutation for early-onset Alzheimer''s disease that was patented by a sole inventor and licensed to a non-practicing entity (NPE), the Alzheimer''s Institute of America (AIA). Our aims are (1) to relate this story about patents, research tools, and impediments to medical progress, and (2) to inform ongoing debates about how patents affect research, disposition of university inventions, and the distribution of benefits from publicly funded research. We present an account of the hunt for Alzheimer''s genes, their patenting, assignment, and enforcement based on literature, litigation records and judicial decisions. While AIA''s litigation eventually failed, its suits against 18 defendants, including one university, one foundation, and three non-profit organizations were costly in court years, legal fees, and expert time. Reasons for the failure included non-disclosure of co-inventors, State laws on ownership and assignment of university inventions, and enablement. We discuss the policy implications of the litigation, questioning the value of patents in the research ecosystem and the role of NPEs (“patent trolls”) in biotechnological innovation. The case illustrates tactics that may be deployed against NPEs, including, avenues to invalidate patent claims, Authorization and Consent, legislative reforms specifically targeting NPEs, reforms in the America Invents Act, and judicial action and rules for judicial proceedings. In the highly competitive research environment of Alzheimer''s genetics in the 1990s, patents played a minor, subordinate role in spurring innovation. The case produces a mixed message about the patent system. It illustrates many mistakes in how patents were obtained, administered, and enforced, but, eventually, the legal system rectified these mistakes, albeit slowly, laboriously, and at great cost.     

National laboratories as business incubators and region builders

Public sector labs do not appear to have generated as much regional business spinoff as universities and research-intensive businesses. This difference may be explained in large part by the disparate capabilities for and attitudes toward new-firm incubation on the part of parent institutions and other anchor tenants. We believe that federal lab personnel systems, research cultures, geographical isolation, management preferences, and complex public interest issues are responsible. These phenomena are explored in an intensive case study of startups associated with Los Alamos and Sandia National Laboratories in New Mexico. Interviews conducted with 33 firms confirm many barriers to incubation, but also reveal some advantages offered by public labs and suggest that changes in attitude, culture, and policy can make a difference. We explore the difficult issues of property rights assignment, public employee conflict-of-interest rules, and the use of public sector equity in spinoffs, and we conclude that startup efforts have been underfunded. Lab partnerships with large corporations in comparison are expensive, hoard labor, and are less effective at transferring technology. Recommendations for improvement of the incubation process include entrepreneurial leave and training, streamlining of conflict-of-interest, patent, and licensing procedures, and lab based efforts to connect would be entrepreneurs with sources of business assistance, space and capital.     

License Compliance Issues For Biopharmaceuticals: Special Challenges For Negotiations Between Companies And Non-Profit Research Institutions

Biopharmaceuticals are therapeutic products based on biotechnology. They are manufactured by or from living organisms and are the most complex of all commercial medicines to develop, manufacture and qualify for regulatory approval. In recent years biopharmaceuticals have rapidly increased in number and importance with over 400() already marketed in the U.S. and European markets alone. Many companies throughout the world are now ramping up investments in biopharmaceutical R&D and expanding their portfolios through licensing of early-stage biotechnologies from universities and other non-profit research institutions, and there is an increasing number of license agreements for biopharmaceutical product development relative to traditional small molecule drug compounds. This trend will only continue as large numbers of biosimilars and biogenerics enter the market.A primary goal of technology transfer offices associated with publicly-funded, non-profit research institutions is to establish patent protection for inventions deemed to have commercial potential and license them for product development. Such licenses help stimulate economic development and job creation, bring a stream of royalty revenue to the institution and, hopefully, advance the public good or public health by bringing new and useful products to market. In the course of applying for such licenses, a commercial development plan is usually put forth by the license applicant. This plan indicates the path the applicant expects to follow to bring the licensed invention to market. In the case of small molecule drug compounds, there exists a widely-recognized series of clinical development steps, dictated by regulatory requirements, that must be met to bring a new drug to market, such as completion of preclinical toxicology, Phase 1, 2 and 3 testing and product approvals. These steps often become the milestone/benchmark schedule incorporated into license agreements which technology transfer offices use to monitor the licensee's diligence and progress; most exclusive licenses include a commercial development plan, with penalties, financial or even revocation of the license, if the plan is not followed, e.g., the license falls too far behind.This study examines whether developmental milestone schedules based on a small molecule drug development model are useful and realistic in setting expectations for biopharmaceutical product development. We reviewed the monitoring records of all exclusive Public Health Service (PHS) commercial development license agreements for small molecule drugs or therapeutics based on biotechnology (biopharmaceuticals) executed by the National Institutes of Health (NIH) Office of Technology Transfer (OTT) between 2003 and 2009. We found that most biopharmaceutical development license agreements required amending because developmental milestones in the negotiated schedule could not be met by the licensee. This was in stark contrast with license agreements for small molecule chemical compounds which rarely needed changes to their developmental milestone schedules. As commercial development licenses for biopharmaceuticals make up the vast majority of NIH's exclusive license agreements, there is clearly a need to: 1) more closely examine how these benchmark schedules are formed, 2) try to understand the particular risk factors contributing to benchmark schedule non-compliance, and 3) devise alternatives to the current license benchmark schedule structural model. Schedules that properly weigh the most relevant risk factors such as technology classification (e.g., vaccine vs recombinant antibody vs gene therapy), likelihood of unforeseen regulatory issues, and company size/structure may help assure compliance with original license benchmark schedules. This understanding, coupled with a modified approach to the license negotiation process that makes use of a clear and comprehensive term sheet to minimize ambiguities should result in a more realistic benchmark schedule.     

Parting the ivory curtain: understanding how universities support a diverse set of startups

Universities are widely recognized as a critical source of technological innovation and are heralded for the entrepreneurial ventures cultivated within their walls. To date, most research has focused on academic entrepreneurship—new ventures that spin out of academic laboratories. However, universities also give rise to startups that do not directly exploit knowledge generated within academic laboratories. Such firms—and the societal and economic benefits they create—are an important contribution of modern universities. We propose a framework for understanding the full scope of university entrepreneurship and its driving factors, with the goal of providing scholars, university administrators, and policymakers with insights regarding the resources required to foster entrepreneurship from within the ivory tower.     

Promoting university startups: international patterns, vicarious learning and policy implications

Anecdotal evidence indicates universities around the world fashion programs to permit or encourage university-linked start ups, in pursuit of improved regional wealth and job creation, often influenced by the iconic vision of Silicon Valley. This paper explores whether these programs are leading to a pattern of similar startups across the world, and gradually improving performance, or to ongoing variation in activities and outcomes, with potential for both harmful and serendipitous unintended outcomes. We use a theoretical lens of research on multiple organizations trying to learn from others—or repeated vicarious organizational learning. The paper first suggests that while startup programs share similar goals they do not generate similar startups across regions and time, with important variation in structure, links to home schools, and localization. It then posits that these programs appear to have varied outcomes in terms of their economic goals, and stresses the difficulty and importance of evaluating this issue. Finally, the paper details important potential unintended (collateral) outcomes, both harmful and valued. Dangers noted include not only traditional concerns with science norms or faculty time, but also the potential impact on humanities and the social sciences. Potential collateral benefits include facilitating the ability of students and citizens to create new forms of value more broadly. Theoretically, the paper speculates that ongoing vicarious learning by multiple organizations in this context may increase or at least sustain variation in outcomes, leading to some excellent but many indeterminate or harmful outcomes rather than homogenization among startups or outcomes. From a policy viewpoint, our review suggests that policymakers should abandon the search for a ‘secret sauce’ that will assure regional growth from startups. Instead, we suggest that they tailor programs to local skills and experience, actively monitor economic and non-economic impact, and expand the overall vision to include values and skills of autonomy and the creation of new forms of value more broadly.     

Signaling in academic ventures: the role of technology transfer offices and university funds

University spinoffs, an important subset of high-tech start-up companies, operate in a context characterized by marked information asymmetries that limit their chances of obtaining financing. Given the uncertainty and imperfect information that characterize these investment opportunities, signals about their potential value deserve further attention. We investigate the relationship between the main stakeholders involved in the process of creating a university spinoff—that is, the academic founders, the university technology-transfer office, and private investors—focusing on the role of public grants as effective signals that attract private venture capital (VC) funding. Using the database of all spinoff companies established to exploit inventions assigned to the University of Michigan from 1999 to 2010, we determine how the funds provided through the university technology-transfer office influence VC follow-on funding and consequent spinoff growth, controlling for the spinoff’s technology, the founders’ human capital, and the network’s resources. The empirical results support a signaling effect of the commercialization funds provided by the university and suggest an indirect impact on the growth of the spinoff’s sales through the mediating effect of VC financing.     

Entrepreneurial activity and regional competitiveness: evidence from European entrepreneurial universities

The interesting relationship between entrepreneurial activity and regional competitiveness has been a major focus of academics, university managers, and policy makers during the past decades—in particular the role of institutions in the establishment of political, social, and economic rules-. For example, since the enactment of the US Bayh–Dole Act more than 30 years ago, many American cities and regions are increasingly viewing universities as potential engines of economic growth. In these new socioeconomic scenarios, the role of entrepreneurial universities is not only generates/transfers knowledge but also contributes/provides leadership for the creation of entrepreneurial thinking, actions, and institutions. Previous studies have shown the university’s role in economic development, but no empirical study has analyzed the entrepreneurial activity generated by university students per university at the country/regional level of analysis. The purpose of this paper is to explore the impact of the university’s entrepreneurial activity on regional competitiveness. Adopting the institutional economics and the endogenous growth approaches, a proposed conceptual framework was developed and tested with structural equation modeling using data from 102 universities located in 56 NUTS II of 12 European countries. Our results evidenced that informal factors (e.g., attitudes, role models) have a higher influence on university entrepreneurial activity than formal factors (e.g., support measures, education and training). Our results also evidenced a higher contribution of universities on regional competitiveness, in particular, when we used social measures (talent human capital) instead economic measures (GDP per capita).     

Effects on academia-industry collaboration of extending university property rights

Several recent studies show European university scientists contributing far more frequently to company-owned patented inventions than they do to patents owned by universities or by the academic scientists themselves. Recognising the significance of this channel for direct commercialisation of European academic research makes it important to understand its response to current Bayh-Dole inspired reforms of university patenting rights. This paper studies the contribution from university scientists to inventions patented by dedicated biotech firms (DBFs) specialised in drug discovery in Denmark and Sweden, which in this respect share a number of structural and historic characteristics. It examines effects of the Danish Law on University Patenting (LUP) effective January 2000, which transferred to the employer university rights to patents on inventions made by Danish university scientists alone or as participants in collaborative research with industry. Sweden so far has left property rights with academic scientists, as they also were in Denmark prior to the reform. Consequently, comparison of Danish and Swedish research collaboration before and after LUP offers a quasi-controlled experiment, bringing out effects on joint research of university IPR reform. In original data on all 3,640 inventor contributions behind the 1,087 patents filed by Danish and Swedish DBFs 1990–2004, Difference-in-Difference regressions uncover notable LUP-induced effects in the form of significant reductions in contributions from Danish domestic academic inventors, combined with a simultaneous substitutive increase of non-Danish academic inventors. A moderate increase in academic inventions channelled into university owned-patents does appear after LUP. But the larger part of the inventive potential of academia, previously mobilised into company-owned patents, seems to have been rendered inactive as a result of the reform. As a likely explanation of these effects the paper suggests that exploratory research, the typical target of joint university-DBF projects in drug discovery, fits poorly into LUP’s requirement for ex ante allocation of IPR. The Pre-LUP convention of IPR allocated to the industrial partner in return for research funding and publication rights to the academic partner may have offered more effective contracting for this type of research. There are indications that LUP, outside the exploratory agenda of drug discovery, offers a more productive framework for inventions requiring less complicated and uncertain post-discovery R&D.

New challenges for universities in the knowledge triangle

This paper discusses the role of higher education institutions within the framework of the knowledge triangle between academic education, scientific research and innovation, as it has gained importance in recent years as a framework for innovation policies especially in the OECD and Europe. First, complementary concepts of universities’ outreach activities and extended role model such as ‘third mission’, ‘triple helix’, ‘entrepreneurial or civic university’ models and ‘smart specialization’ are reflected against their fit with the concept of the knowledge triangle, also with respect to new requirements for university governance. Second, a new understanding of spillovers between public sectors research and the business sector according to knowledge triangle is presented.

     

Redeploying Bayh-Dole: beyond Merely doing good to optimizing the potential in results of taxpayer-funded research

Opinions about the Bayh-Dole Act of 1980 and its implementation by US universities can depend on whether one views the Act as a series of tactics that are ends in themselves or as a policy declaration designed to protect the public against nonuse of taxpayer-funded discoveries and encourage their commercialization, utilization, and public availability. Those views appear to influence how universities and their leaders measure performance and define success, identify and allocate resources, approach transfer strategies, and negotiate terms and apportion risks relative to those terms. Those who view the Act as tactical tend to obscure the broader policy objectives which can result in substantial amounts of university research that is “never commercialized” (President’s Council of Advisors 2003), “restrained” (Schacht 2010b), and “left unused and unapplied” (Seipman in Univ Dayt Law Rev 30:209–243, 2004). Society then is deprived of the new products, services, approaches and experiences that can stimulate economic growth and advance human welfare. These and other consequences demand evaluations and assessments of university practices and behaviors and the extent to which they narrowly serve the Act’s tactics or more broadly serve its purposes of pursuing and maximizing the potential usefulness of the results of taxpayer-funded research. Too frequently, there seems to be a disconnect between federal policy and practices adopted or tolerated by universities and their leaders to implement that policy.     

The activities of university knowledge transfer offices: towards the third mission in Italy

Establishing deeper engagement with industry and society has recently become a key concern of universities. To pursue this goal, universities—as well as other public research organizations—have started to reorganize internal resources, to redefine their activities and policies, and to redesign their overall knowledge transfer (KT) business models. As a consequence, in several countries a wide heterogeneity exists in the types of KT models adopted and in the outcomes arising from KT activities. By performing a cluster analysis and a multinomial logit regression on an extensive dataset that almost covers the entire population of Italian universities, in this study we analyze (1) whether models of KT characterized by a broader engagement with society are gradually substituting models more focused on technology commercialization, and (2) which factors related to the availability of resources and universities’ strategic intention better explain existing differences. Insights from the study might help university managers to define the most appropriate actions to fully undertake the implementation of the university third mission.     

Studying women legal scholars: the challenges of life history

Biographies of prominent women often advance inquiries that lead to easy and uninteresting conclusions that their subject should be celebrated or ignored. In contrast, this article argues for more life histories of women legal scholars that bring out the complexity of their lives. It suggests three ways to execute this work that guard against the making of simple binary conclusions. First, it argues that these studies should be open inquiries that present a range of views of their subject, from both the past and present, and encourage audiences to form their own judgments. This approach will help both reader and scholar to recognise their biases. Second, it makes a case for treating legal scholars differently from pure educators, scholars or lawyers. It suggests that their unique role should inform the work’s central inquiries. Finally, it argues that unearthing a subject’s attitude towards feminism and feminist legal scholarship can be done in ways that strengthen the work’s contribution to the history of the discipline.