Objectives, Characteristics and Outcomes of University Licensing: A Survey of Major U.S. Universities

This paper describes results of our survey of licensing at 62 research universities. We consider ownership, income splits, stage of development, marketing, license policies and characteristics, goals of licensing and the role of the inventor in licensing. Based on these results we analyze the relationship between licensing outcomes and both the objectives of the TTO and the characteristics of the technologies. Patent applications grow one-to-one with disclosures, while sponsored research grows similarly with licenses executed. Royalties are typically larger the higher the quality of the faculty and the higher the fraction of licenses that are executed at latter stages of development. Sponsored research is more likely to be included in a license if the new technology is at an early stage of development or if the TTO evaluates it as important. We find that additional disclosures generate smaller percentage increases in licenses, and those increases in licenses generate smaller percentage increases in royalties.     

撤销许可证就一定是行政处罚吗?——对一类行政许可行为性质的反思

在行政许可领域中 ,对于一些许可事项 ,法律明确赋予被许可人一定的作为义务 ,这些义务是被许可人取得特定权利、获得特定资格的基础 ,此类许可在性质上属于附法定义务的许可。如果被许可人不依法履行此类法定义务 ,有关行政机关可依法取消赋予其的特定权利或资格 ,终止许可关系 ,这种废止许可的行为不属于行政处罚法所称的“吊销许可证、执照”的调整范围     

行政许可标准的冲突及解决

行政许可标准,是对行政许可的法定条件、程序的解释和细化,在学理上属于许可的裁量基准,在功能上构成了许可获得的限制性条件,在形式上表现为一个自上而下的"阶梯式"规范体系。在相对集中行政许可视角下,市场准入过程往往是多个单一许可组成的复合许可过程,由此产生了不同部门间实体和程序标准的冲突现象。其发生的内在机理是行政权及许可背后的部门利益与家长主义规制,外在形式则表现为复数机关参与的异位规范间的冲突,性质上多属经验冲突而非逻辑冲突。由此,解决的路径在于:一是现行行政服务中心基础上不断修正的行政协调模式;二是具有共性效力之协调技术的提炼;三是通过基准制定和公布义务的规则治理。     

Overprovision and the licensing (Scotland) act 1976

This paper examines Scottish licensing law, in particular the granting of licenses to supply alcoholic liquor. Any application for a license must be granted unless one or more of four conditions are fulfilled. One of these, that the award would lead to overprovision, is the central concern of this study. The paper does not investigate why the consumption and distribution of alcohol are regulated nor why regulatory control takes the form it does. ¹ The starting point is rather that regulation exists and takes a particular form. Attention is focused on the operation of this regulatory control and with how it might be improved.In the next section, some of the key features of the licensing law and its appeals are reviewed, establishing the importance of evidence of the presence or otherwise of overprovision. Section II discusses the use of density of licensed premises as a measure of provision, indicates the problems, and argues that a measure might be refined and validated by entering it in an equation explaining the retail price of alcoholic beverages. Section III examines empirically the relationship between price and licensing density.     

Decision Making in Delinquency Cases: The Role of Race and Juveniles' Admission/Denial of the Crime

Investigated how accused delinquents' admission/denial of their crimes affected adjudication and disposition decisions. An archival analysis of 2,043 adjudication decisions in 16 Georgia counties found that juveniles who admitted committing their crimes were treated more severely than juveniles who denied committing their crimes. Whites were more likely than Blacks to admit committing the crime, and, after controlling for this and other legal factors, race did not have a significant effect. In the second study, 67 judges, 53 probation officers, and 126 court service workers made adjudication and disposition decisions about three juveniles in an experimental simulation in which race of juvenile, length of prior record, and the juvenile's reaction to the crime (admitting or denying it) were systematically manipulated. Consistent with the archival study, juveniles who admitted committing their offense were treated more severely than juveniles who denied committing their offense. Possible reasons are discussed for why admitting a crime leads to more punishment.     

Assessing the risk of recidivism in physicians with histories of sexual misconduct

Physicians who engage in sexual conduct with patients usually cause serious harm and have a high rate of recidivism. Although offending physicians may lose their privilege to practice, they have the right to appeal for restoration of the license. Yet medical licensing board members do not currently have any clear standards by which to predict whether a given physician is likely to abuse again. Using New York as a paradigm, this paper offers practical, clinically based guidelines for assessing the risk of restoring an offending physician's license. These guidelines are derived from psychoanalytic theories of character, the insights of therapists who have worked with abusive physicians, and the psychiatric model of assessing dangerousness. Recognizing character patterns and psychological vulnerabilities of physicians with histories of sexual misconduct will help board members identify those who are at high risk of abusing again if their licenses are restored.     

Patent auctions: business and investment strategy in IP commercialization

Legal context. This article concerns patent sale and licensing,asset deals connected with M&A and intangible asset transactions. Key points. Patent owners might find patent auctions a fastway to sell or license their patents. There is a high probabilitythat bidders will purchase or license low- or no- value patentsbecause patent auctions set a very tight time frame for bidders’due diligence. The nature of the patent right creates a bigimbalance in terms of knowledge between owner of the patentand the purchaser or licensee; the latter party can only minimizethe risk of purchasing or licensing a "zero" or low value patentby receiving sufficient time to investigate the patents. IPauctions may however be a better and safer means of purchasingor licensing domain names or trade marks, due to their legalnature. Practical significance. Many companies might believe that patentauction is a swift and effective way to find a purchaser ora licensee for their IP rights. Even so, it is imperative thatthe bidders themselves conduct a proper due diligence of thepatents offered, corresponding to their needs and to their assessmentof their true financial and business value.     

乡村医生执业的法律困境与对策研究

《乡村医生从业管理条例》规定2004年后新进入村医队伍的人员必须具备执业医师资格或执业助理医师资格,但由于执业医师资格考试的方式和内容与农村实际情况不符合,乡村医生的身份转变缺乏激励因素,乡村医生行业的吸引力明显不足,乡村医生面临后继乏人的局面。《执业医师法》对村卫生室执业的执业(助理)医师在执业范围、执业场所等问题的规定与农村实际不相符合,也带来一系列的现实问题。应当从农村实际出发,降低乡村医生的准入门槛,逐步探索和建立适应农村实际的乡村医生培养方式,加强对农村医疗卫生实际的实证研究,制定和完善适应农村地区实际情况的法律、法规和政策     

License terms for medical use licenses--NRC. Final rule

The Nuclear Regulatory Commission is amending its regulations pertaining to the medical use of byproduct material to eliminate the 5-year term limit for medical use licenses. License terms for licenses issued under these regulations will be set by policy. Other materials licenses are issued for up to 10 years. The NRC will issue some licenses for shorter terms if warranted by the individual circumstances of license applicants. The amendment reduces the administrative burden of license renewals on a 5-year cycle for both NRC and licensees and supports NRC's goal of streamlining the licensing process.     

Five Years Later: Reconsidering the Original ABA Report on MDP

Reconsidering the original report issued in 1999 by the ABA Commission on Multidisciplinary Practice, this essay suggests that that report properly attempted to deal with questions of legal ethics that might arise if the practice of law by lawyers were integrated into an enterprise in which nonlawyers had a significant degree of ultimate control, but that the commission, perhaps because of undue time pressure, neglected to pursue these questions deeply enough. This essay suggests that more was needed than a proposed mechanism for self-certification of compliance with rules of legal ethics, coupled with possible review of compliance. The "more" that was needed, this essay further suggests, was a proposal for the licensing of an enterprise in which lawyers do not have exclusive ultimate control, as a precondition to permitting lawyers in the enterprise to offer legal services to the general public. Thus, before it could offer legal services to the general public, such an enterprise would need to comply with requirements for obtaining a license, and noncompliance with rules of legal ethics could bring into play traditional disciplinary measures including, where appropriate, suspension or revocation of the license.     

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.     

行政许可与个人自由

在资源配置效益之外从个人自由的角度论证行政许可的本质 ,运用分析法学的方法解析许可和行政许可的法律意义 ,则行政许可就是通过行政程序创设个人自由或财产性权利的构成性事实。行政许可权的合理性与正当限度即在于个人自由与公共利益的平衡。公共利益概念存在不确定性和“羊皮化”倾向 ,而对治理的实质理性的追求是不可靠的 ,应该注重程序制度的建设和程序权利的维护。     

UNILATERAL REFUSALS TO LICENSE

Most antitrust claims relating to intellectual property involvechallenges to agreements, licensing practices, or affirmativeconduct involving the use or disposition of the intellectualproperty rights or the products they cover. However, sometimesan antitrust claim centers on an intellectual property owner'srefusal to use or license an intellectual property right, perhapscoupled with efforts to enforce the intellectual property rightagainst infringers. The allegation may be that the intellectualproperty right is so essential to competition that it must belicensed across the board, or that a refusal to license it toone particular party was discriminatory, or that in contexta refusal to license helped a monopolist to acquire or maintainmarket power. Claims based on a unilateral refusal to licensepresent important issues at the center of the tension betweenantitrust and intellectual property. Unilateral refusal to licensecases cut to the heart of the intellectual property owner'sright to exclude others from practising the intellectual property.As such, efforts to invoke antitrust law in this context deservespecial scrutiny. We examine the basic principles relating tounilateral refusals to license intellectual property rights.We then analyze the various sets of circumstances in which antitrustplaintiffs argue for exceptions to those basic rules. Finally,we distinguish unilateral from concerted and conditional refusalsto deal.     

Industry/University Licensing: Characteristics, Concerns and Issues from the Perspective of the Buyer

The authors previously explored invention licensing from the university's perspective. In this paper we focus on the process from the perspective of firms activity engaged in licensing technology. A survey of industry licensing professionals addresses why some firms license technologies from universities and why others do not. The paper then considers the stage of development of university technologies, the characteristics of their licensing contracts, and sources of information about university technologies, all to better understand how the process works and what advantages and disadvantages it offers to all participants.     

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.     

Toward Drug Control: Exclusion and Buyer Licensing

The uncertainties associated with the precise nature of legalization regimes and with their expected outcomes sometimes are used to justify the maintenance of drug prohibition. This paper details the role that buyer licensing and exclusion might play in implementing a low-risk, post-prohibition drug regulatory regime. Buyer licensing and exclusion provide assistance to those who exhibit or are worried about self-control problems with drugs, while not being significantly constraining upon those who are informed and satisfied drug consumers. Relative to prohibition, licensing and self-exclusion can be part of a drug regulatory structure that is much more finely tuned to the risks of harms stemming from drug use.     

Regulation of Firearm Dealers in the United States: An Analysis of State Law and Opportunities for Improvement

Firearms were associated with 30, 136 deaths in the United States in 2003. Most guns are initially sold to the public through a network of retail dealers. Licensed firearm dealers are an important source of guns for criminals and gun traffickers. Just one percent of licensed dealers were responsible for more than half of all guns traced to crime. Federal law makes it difficult for ATF to inspect and revoke the licenses of problem gun dealers. State licensing systems, however, are a greatly under-explored opportunity for firearm dealer oversight. We identify and categorize these state systems to identify opportunities for interventions to prevent problem dealers from supplying guns to criminals, juveniles, or gun traffickers. Just seventeen states license gun dealers. Twenty-three states permit routine inspections of dealers but only two mandate that those inspections occur on a regular basis. Twenty-six states impose record-keeping requirements for gun sales. Only thirteen states require some form of store security measures to minimize firearm theft. We conclude with recommendations for a comprehensive system of state licensing and oversight of gun dealers. Our findings can be useful for the coalition of more than fifty U.S. mayors that recently announced it would work together to combat illegal gun trafficking.     

铁路餐饮服务许可管理存在问题探讨

为贯彻落实国家六部委制定的《铁路运营食品安全管理办法》,规范铁路餐饮服务和食品流通许可工作,原铁道部制定了《铁路餐饮服务和食品流通许可管理办法》。但在执行过程中,发现在许可的条件、提交的材料、现场核查与结果判定、撤销许可的情形等方面存在问题,在此提出讨论。     

Compensation for workplace injury leading to suicide in Australia

Workplace-related death by suicide raises a number of difficult issues in the context of workers compensation. On first reading, workers compensation statutes usually prevent recovery of compensation where an injury is self-inflicted, suggesting that compensation for suicide will be excluded. Additionally, compensation is usually denied when the nexus between employment and injury is broken which is frequently the defence to any claim by the dependants of workers who takes their own life following a work injury. This article examines the Australian landscape in relation to the evolution of principles that apply to consideration of workers compensation claims where suicide is an element.