Government-owned inventions; availability for licensing. National Institutes of Health, Public Health Service, DHHS. Notice

The inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.     

Government-owned inventions; availability for licensing. National Institutes of Health, Public Health Service, DHHS. Notice

The inventions listed below are owned by agencies of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.     

Government-owned inventions; availability for licensing. National Institutes of Health, Public Health Service, DHHS. Notice

The invention listed below is owned by an agency of the U.S. Government and is available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development.     

A new approach to measuring time-lags in technology licensing: study of U.S. academic research institutions

This paper contributes to measurement of licensing performance of U.S. research institutions by suggesting an approach for identifying time-lags in the licensing process. Licensing is a multi-state process starting with a disclosure, and resulting in intermediate outcomes such as patents, licensing agreements, and licensing income. The time duration among these variables is critical in understanding which investment is responsible for which outcome. This study develops a statistic procedure estimating time-lag coefficients among licensing variables using an unstructured regression model (OLS). The procedure is applied to 46 U.S. academic research institutions using the licensing survey data from 1991 to 2007 by Association of University Technology Manager. The results present individual time-lag relationships between each pair of licensing variables.     

Foreign patents for the technology transfer from laboratories of U.S. federal agencies

The Journal of Technology Transfer - This paper documents the importance of foreign patents for the technology transfer of inventions created in the laboratories of the U.S. federal agencies....     

Patenting nanotechnology

Universities and companies are rushing to the patent office in record numbers to patent nanotechnology inventions. This rush to the patent office is so significant that many law firms have established nanotechnology practice groups and the U.S. Patent and Trademark Office has now created a new technology class designed to track nanotechnology products. Three big differences between the emerging science of nanotechnology and other inventions make the role of patents more significant in this arena than elsewhere. First, this is almost the first new field in a century in which the basic ideas are being patented at the outset. In many of the most important fields of invention over the past century--computer hardware, software, the Internet, even biotechnology--the basic building blocks of the field were either unpatented or the patents were made available to all users by government regulation. In others, patents were delayed by interferences for so long that the industry developed free from their influence. In nanotechnology, by contrast, companies and universities alike are patenting early and often. A second factor distinguishing nanotechnology is its unique cross-industry structure. Unlike other new industries, in which the patentees are largely actual or at least potential participants in the market, a significant number of nanotechnology patentees will own rights not just in the industry in which they participate, but in other industries as well. This overlap may significantly affect their incentives to license the patents. Finally, a large number of the basic nanotechnology patents have been issued to universities, which have become far more active in patenting in the last twenty-five years. While universities have no direct incentive to restrict competition, their interests may or may not align with the optimal implementation of building-block nanotechnology inventions. The result is a nascent market in which a patent thicket is in theory a serious risk. Whether it will prove a problem in practice depends in large part on how efficient the licensing market turns out to be.     

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.

Reflections on Mansfield, Technological Complexity, and the “Golden Age” of U.S. Corporate R&D

We focus on two themes, among those in Mansfield's work, particularly relevant to understanding the role of large corporations in the U.S. innovation system: (1) the development of science-based inventions into market-ready innovations, and (2) the imitation by one firm of another's technology. Both of these phenomena, we propose, depend critically on the extent of technological and organizational complexity characteristic of current products and potential innovations. Reporting on recent survey research of our own, we argue that the origins and potentially the future of U.S. leadership in technology-based economic growth lie in the complementarity of large corporations and entrepreneurial start-ups, each exploring and exploiting the market potential of different types of science-based innovations.     

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.     

Technology transfer practice in japanese corporations: Meeting new service requirements

Japanese corporations are undergoing radical transition: they have begun to reassess the role, organization, and management of their internal R&D and technology commercialization activities in response to changing market, business, and technical conditions. From large consumer electronics firms such as Matsushita and Sony to the semiconductor and computing conglomerates such as Fujitsu and NEC, these organizations are under considerable pressure to both invent and innovate more rapidly and cheaply than ever before. As technologies become more complex and integrated—such as the convergence of electronics, computing, video, and broadcast television—it is no longer practical to assume that all of a firm's R&D needs can be met internally. This paper looks first at how major Japanese corporations have embraced technology transfer mechanisms such as licensing, joint collaboration, and the outsourcing of R&D to manage these changes dynamically and effectively. Secondly, this paper looks at why Japanese firms' record of managing collaboration and licensing, particularly on an international basis, has been disappointing because of a number of problems and barriers. These difficulties, which are compounded by the further externalization of research and technology and by increased licensing activity, have given rise to a need for new technology transfer services which, until recently, have not been available either within the organization or through local consulting firms in Japan. This paper concludes by outlining strategic and operational guidelines for managing licensing and collaboration arrangements between U.S. and Japanese firms which are also applicable in the general case. These insights are based on the experiences of managing licensing and collaboration programs between Japanese and U.S. organizations from the dual perspectives of two licensing firms—Innovation Partners, kk. in Japan and Competitive Technologies, Inc. of the United States.     

Beyond formal university technology transfer: innovative pathways for knowledge exchange

The Journal of Technology Transfer - University technology transfer is often associated with formal transmission of science-based inventions, for instance through the licensing of patented...     

DNA as patentable subject matter and a narrow framework for addressing the perceived problems caused by gene patents

Concerns about the alleged harmful effects of gene patents--including hindered research and innovation and impeded patient access to high-quality genetic diagnostic tests--have resulted in overreactions from the public and throughout the legal profession. These overreactions are exemplified by Association for Molecular Pathology v. U.S. Patent and Trademark Office, a 2010 case in the Southern District of New York that held that isolated DNA is unpatentable subject matter under 35 U.S.C. § 101. The problem with these responses is that they fail to adequately consider the role that gene patents and patents on similar biomolecules play in facilitating investment in the costly and risky developmental processes required to transform the underlying inventions into marketable products. Accordingly, a more precisely refined solution is advisable. This Note proposes a narrowly tailored set of solutions to address the concerns about gene patents without destroying the incentives for companies to create and commercialize inventions derived from these and similar patents.     

The Effects of University Patenting and Licensing on Downstream R&D Investment and Social Welfare

A central argument behind the Bayh-Dole Act presumed that firms had no incentives to invest in downstream R&D aimed at developing university inventions committed to the public domain. The empirical evidence on university patenting and licensing is partly at odds with the premises of this argument. Non-exclusive licensing of university patents has been common and lucrative, and in the area of biomedical technologies university patents and licensing restrictions may be a hindrance to downstream R&D, rather than a stimulus. The paper presents a model of R&D competition based on a university invention where appropriability conditions are defined by the patentability of downstream innovations and imitation opportunities. A comparison of equilibria under “open access” to university inventions and under “university patenting” shows that only under restrictive conditions the latter regime results in increased R&D investment and social welfare. In general, university licensing royalties are therefore a poor gauge of social welfare gains from university patenting. This is an extensive revision of the paper “University Patents, R&D Competition, and Social Welfare” presented at the conference on University Spin-Offs at the Université du Québec à Montréal on February 27th, 2004. I would like to thank the conference participants and a referee from the journal for useful comments and suggestions.     

美国《2018年出口管制法》评析与启示

美国《2018年出口管制法》在术语定义和政策声明、出口管制的权限和管理、许可证、确定和控制"新兴和基础技术"出口的要求、涉及与美国全面禁运的国家有关的审查、惩罚和强制执行等方面作出了许多新规定。该法使美国出口管制体系走向法典化、系统化和多边化,建立跨部门许可审查机制,确立"合规协助"条款,扩大了"新兴和基础技术"这一出口管制范围,并扩张出口管制域外管辖权,同时加强了惩罚和执行力度。我国应注重"新兴与基础技术"的管制,完善出口管制系列清单,扩大出口管制管理机构的执法权限,为出口经营者出口合规提供具体指导,严格执行阻断法,推进双边与多边出口管制标准的设立以应对该法的实施。     

Disentangling effort and performance: a renewed look at gender differences in commercializing medical school research

Recently, questions about gender gaps in science have extended to academic technology transfer. Using systematic data on US medical school faculty, we capture both behavior and performance, examining the hypothesis that women are less likely than men to commercialize their research findings. We pooled faculty invention data from ten departments in three Academic Health Centers from 1991 to 1998??a period when patenting had become prevalent and other researchers note that a gender gap was pronounced. Rather than focusing on patenting, we capture the first step in the commercialization process, as well as the subsequent successful licensing of faculty inventions to a company. We find no significant gender differences in the likelihood of reporting inventions or successfully commercializing them. We do find differences in the number of inventions reported, however, with women disclosing fewer inventions than their male counterparts. Our results demonstrate that gender effects are highly conditioned by employment context and resources. We attribute differences in our findings with regards to gender to the use of outcome measures that capture both behavior and performance, and the inclusion of a more extensive set of control variables.     

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.     

License term for medical use licenses--NRC. Proposed rule

The U.S. Nuclear Regulatory Commission is proposing to amend 10 CFR part 35 to eliminate the five-year term limit for medical use licenses in 10 CFR 35.18. License terms for licenses issued pursuant to part 35 would be set, by policy up to ten years, as are the license terms for other materials licenses. The NRC would issue some licenses for shorter terms, if warranted by the individual circumstances of license applicants. The amendment would reduce the administrative burden of license renewals for both NRC and licensees, and would support NRC's goal of streamlining the licensing process.     

Patent first, ask questions later: morality and biotechnology in patent law

This Article explores the U.S. "patent first, ask questions later" approach to determining what subject matter should receive patent protection. Under this approach, the U.S. Patent and Trademark Office (USPTO or the Agency) issues patents on "anything under the sun made by man," and to the extent a patent's subject matter is sufficiently controversial, Congress acts retrospectively in assessing whether patents should issue on such interventions. This practice has important ramifications for morally controversial biotechnology patents specifically, and for American society generally. For many years a judicially created "moral utility" doctrine served as a type of gatekeeper of patent subject matter eligibility. The doctrine allowed both the USTPO and courts to deny patents on morally controversial subject matter under the fiction that such inventions were not "useful." The gate, however, is currently untended. A combination of the demise of the moral utility doctrine, along with expansive judicial interpretations of the scope of patent-eligible subject matter, has resulted in virtually no basis on which the USTPO or courts can deny patent protection to morally controversial, but otherwise patentable, subject matter. This is so despite position statements by the Agency to the contrary. Biotechnology is an area in which many morally controversial inventions are generated. Congress has been in react-mode following the issuance of a stream of morally controversial biotech patents, including patents on transgenic animals, surgical methods, and methods of cloning humans. With no statutory limits on patent eligibility, and with myriad concerns complicating congressional action following a patent's issuance, it is not Congress, the representative of the people, determining patent eligibility. Instead, it is patent applicants, scientific inventors, who are deciding matters of high public policy through the contents of the applications they file with the USTPO. This Article explores how the United States has come to be in this position, exposes latent problems with the "patent first" approach, and considers the benefits and disadvantages of the "ask questions first, patents later" approaches employed by some other countries. The Article concludes that granting patents on morally controversial biotech subject matter and then asking whether such inventions should be patentable is bad policy for the United States and its patent system, and posits workable, proactive ways for Congress to successfully guard the patent-eligibility gate.     

Industry/university licenses: A negotiating strategy

A lament often heard from U.S. industry licensing executives about their university (“university” refers to universities, not-for-profit research institutions, and hospitals) counterparts is, “they (university technology licensing officers) just don't understand business.” Conversely, university licensing managers criticize their industry counterparts for not understanding (or even trying to understand) the mission and constraints of university technology transfer. University licensing managers also accuse their industry counterparts as being predatory and seeking to take unfair advantage of university technology licensing opportunities. The purpose of this paper is to enhance the dialog between university licensors and industry licensees. This paper reviews the basis of university licensing, decries the focus on financial considerations, suggests references for further study of valuation and pricing issues, delineates companies' and universities' needs in licensing embryonic university technologies, and proposes a negotiation strategy.     

Currently effective Indian Health Service eligibility regulations. Indian Health Service, HHS. Republication of currently effective Indian Health Service eligibility regulations

The HHS is publishing in the Federal Register, final regulations governing eligibility for services from the Indian Health Service. The eligibility regulations currently codified at 42 CFR part 36 are under a congressional moratorium. Republishing the regulations that are currently in effect while the codified regulations are under moratorium is being done for the convenience of the public and in conformance with the requirement of the Administrative Procedure Act, 5 U.S.C. 552(a)(1), that the Code of Federal Regulations (CFR) must contain currently effective regulations.