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.     

非营利组织税收政策的双重效应分析

由于非营利组织在公益服务领域的特殊地位和作用,各国政府普遍采用了优惠的税收政策来支持其发展.各国对非营利组织税法规制具有优惠性、特殊性和限制性等一些共同特征,其形成原因是由于宗教自由、弥补政府和市场缺陷等方面的需要.该项政策对非营利组织和社会经济发展具有双重效应.我国应积极借鉴他国政府这一方面税法规制政策的经验和做法,努力改善对我国非营利部门的税收管理工作,以促进我国非营利组织的健康发展.     

Academic patenting: the importance of industry support

This paper provides evidence that university-industry collaboration is important for turning commercial opportunities into patents. The results suggest that researchers who receive a large share of research grants from industry have a higher propensity to file a patent. Small dissemination grants generally exert a positive effect, whether they come from industry or not. It also finds that these interactions do not increase the number of industry owned patents alone but benefit universities’ commercialisation efforts in general.     

非营利性组织的营利行为有效性判断

在非营性利组织的营利行为日渐普遍的情况之下,司法实践必将面临对各种营利行为的有效性判断。从平衡非营利性组织营利行为所带来的利弊这一角度,可以分主体、内容、目的三个层次对非营利性组织营利行为的有效性进行判断。为适应社会团体等组织现实的发展需要,还应建立附条件许可的立法模式,使法律上的判断更具可操作性。     

International conflicts over patenting human DNA sequences in the United States and the European Union: an argument for compulsory licensing and a fair-use exemption

The thought of a large biotech company holding an exclusive right to research and manipulate human genetic material provokes many reactions--from moral revulsion to enthusiasm about the possibilities for therapeutic advancement. While most agree that such a right must exist, debate continues over the appropriate extent of its entitlements and preclusive effects. In this Article, Professor Donna Gitter addresses this multidimensional problem of patents on human deoxyribonucleic acid (DNA) sequences in the United States and the European Union. Professor Gitter chronicles not only the development of the law in this area, but also the array of policy and moral arguments that proponents and detractors of such patents raise. She emphasizes the specific issue of patents on DNA sequences whose function has not fully been identified, and the chilling effect these patents may have on beneficial research. From this discussion emerges a troubling realization: While the legal framework governing "life patents" may be similar in the United States and the European Union, the public perceptions and attitudes toward them are not. Professor Gitter thus proposes a dual reform: a compulsory licensing regime requiring holders of DNA sequence patents to license them to commercial researchers, in return for a royalty keyed to the financial success of the product that the licensee develops; and an experimental-use exemption from this regime for government and nonprofit researchers.     

我国非营利组织管理创新的思路

国际化、信息化以及中国改革开放的实践为非营利组织的发展提供了机遇,也提出了挑战,这就要求我国的非营利组织适应时代要求,积极进行管理创新,迅速发展成熟。     

Software patents in the United States: A balanced approach

This paper tracks the interesting journey of software patents in the United States from both a historic and current standpoint. The U.S patent system has drifted from being strict in the 1970s to being fairly lenient in 1990s and now again strict since 2007. The revolutionizing and famous Bilski case that is redefining the boundaries of software patents is described, and the impact of this Court case on software patents is discussed. The challenges in issuing software patents in terms of proving novelty and non-obviousness are presented in an attempt to bring forward some of the questions in the software patent debate. The uniqueness of software as an invention is analyzed to understand why software should be considered differently compared to other industries. The advantages and disadvantages of software patents are discussed. The paper concludes by providing recommendations and proposing a balanced approach to software patents.     

非营利组织所得税优惠制度比较与借鉴

非营利组织在提供公共物品、保障社会公益方面有弥补政府缺陷的"替代效益",许多国家或地区为了鼓励和促进公益事业,均从所得税法方面对捐赠人和非营利组织自身作了税收优惠的制度安排。我国应进一步提高对捐赠人的税前扣除额,区分非营利组织收入的不同性质给予不同的税收优惠待遇,加强对非营利组织的税收监管。     

外观设计专利权的扩张与限缩—以外观设计专利权与其他知识产权的边界为视角

由于知识产权客体的非物质性,外观设计专利权易与其他知识产权发生竞合与冲突,尤其是与实用艺术作品的著作权、商业外观的商标权和基于《反不正当竞争法》保护的合法权益等。伴随着我国司法实践的进展,上述权利竞合与冲突的问题日益严重。同时,外观设计专利权与其他相关知识产权之间亦存在一定差别,需要在权利客体方面有所区分。借鉴美国、英国、德国和法国的法律经验,只有法国给予完全重叠的保护,其他国家均在外观设计专利权的权利客体方面与其他知识产权加以区分。我国应当进一步明晰外观设计专利权与其他知识产权之间的边界,将纯属著作权保护的作品排除在外观设计保护客体之外,例如服装设计、书籍封面设计、动画形象设计、建筑设计、小摆设;将纯属商标权保护的标识排除在外观设计保护客体范围之外,例如在实用功能或形状结构上没有新创造的商品包装盒(包装袋、包装瓶)、店面装饰装潢;对实用功能或形状结构有新创造的设计,可选择获得外观设计专利权或者其他知识产权保护,否则不能获得外观设计专利权保护。     

公共事业登记管理面临的问题及对策分析

公共事业登记管理是公共事业管理的一个重要组成部分,随着国家一系列法规条例的出台,公共事业登记管理逐渐走上规范化的轨道。在取得成效的同时,公共事业登记管理也面临着许多问题,在一定程度上阻碍了公共事业的发展。因此,对公共事业登记管理的问题及其原因进行深入分析,以此提出相应的完善对策将有着十分重要的意义。     

Using patent filings to measure innovation

Ever since Bennett Woodcroft compiled his seminal index to theearly English patents, it has been recognized that the emanationsfrom Patent Offices contain a wealth of information. Battelle,in their work on patent trends analysis, revealed that approximately50 per cent of patents are used during their lifetime and that80 per cent of the information obtainable from patents is notavailable from any     

The transfer of public science to patented technology: A case study in agricultural science

One of the most difficult challenges in technology transfer is to measure the movement of knowledge from basic scientific research to industrial technology. This paper will report on a study of the linkage between science supported by the Agricultural Research Service (ARS) and patented technology. This study traced the citations from U.S. patents issued in 1987–88 and 1993–94 to scientific research papers linked to the U.S. Department of Agriculture (USDA). The number of patent citations to ARS papers, and to other USDA-supported papers has increased fourfold over the six-year period. A distinct difference also exists between the patent-cited ARS papers and patent-cited extramural USDA-supported papers: ARS papers are in more agriculturally related journals, while the extramural papers were in more basic and biomedical journals. USDA-supported papers were overwhelmingly cited by U.S.-invented patents (in a patent system in which half the patents are foreign-invented). In the primary field of ARS papers (Biology), they are cited much more often by patents than Biology papers from any other publishing organization. Since the publishing organizations and support sources of all the papers cited in these patents have now been identified, we can study the transfer of scientific results to patented technology by institution, by agency, or by any other category of patent or paper holder. The authors thank the Agricultural Research Service of the U.S. Department of Agricultural, especially Dr. Richard Parry, for this paper' use of the study performed for them by CHI Research, Inc. (Grant number 59-0790-6-054)     

Technology transfer offices and university patenting in Sweden and Germany

This paper analyses the factors that impact on the decision of researchers to patent their research results. Particular emphasis is put on the role of technology transfer offices. It builds on a survey of university professors in Sweden and Germany. The regression results show that researchers that received support from the public infrastructure and researchers that have experience with the patenting system—through own previous patents or joint patent applications with firms—are much more likely to apply for patents.     

从权利到工具:失效专利管理研究

失效专利是法律效力的丧失而非价值的丧失,通过价值评估及专利挖掘后完全可以将失去法律保护的这项权利转化为有力的工具,对失效专利进行事后管理可挖掘其剩余价值,促进产业进步。本文从失效专利的概念界定、失效原因及管理的必要性三方面出发,系统梳理和总结了学界关于失效专利管理的相关研究文献。研究发现,失效专利的管理主要围绕专利价值评估、专利申请与审查制度等因素展开。但当前研究在界定失效专利的定义及范围上并不统一,未形成明确的专利价值评估体系,也缺乏针对其管理的必要性分析。鉴于此,对失效专利进行管理需遵从以下路径:首先要厘清失效专利的定义并分析其失效原因,其次要总结失效专利管理的必要性及专利失效规律,最后从失效专利原权利人、相关市场企业以及政府部门等多主体视角出发提出管理对策,使失效专利管理秩序化、科学化。     

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.     

Protecting charities from terrorists … and counterterrorists: FATF and the global effort to prevent terrorist financing through the non-profit sector

What role has FATF played in the global effort to counter terrorist financing through the non-profit sector? How have advocates for the sector responded and what do these developments tell us about FATF’s operations and influence? This article reflects on the emergence and evolution of FATF Recommendation 8, initially introduced as Special Recommendation VIII after the terrorist attacks in the United States on 11 September 2001. We show how the breadth of that recommendation elicited a response in the form of a "transnational advocacy network" among those within the non-profit sector. The resulting process of dialogue and the recent change in the text of the recommendation provide important lessons for scholars and practitioners concerned about FATF's accountability and authority.     

论中药单方专利的创造性认定

随着中药单方专利侵权案件的日益增多,如何认定一个新中药单方是否构成对现有中药单方专利的侵权,显得尤为重要。按照我国《专利法》的规定,必须经过"三性"认定,而新中药单方"三性"认定的关键在于其与现有的中药单方专利相比是否具有创造性。因此,尽快制定中药单方专利的创造性认定标准迫在眉睫。当新中药单方与现有的中药单方专利相比使用了不同的药用部分、不同的剂型导致给药途径改变、不同的炮制方法导致归经改变、不同生产方法、工艺及增加或使用不同的引药、改变现有中药单方专利的混合物组分或组成混合物组分的剂量等时,如果其能在作用同一病症的不同类型、减少毒副作用、显著提高疗效、适应新的病症、作用新的部位等任何一方面有所突破,就应当认定该新中药单方对中药领域的普通技术人员来说具有"非显而易见性",有突出的实质性特点和显著的进步,具有创造性。     

Knowledge diffusion from university and public research. A comparison between US,Japan and Europe using patent citations

This paper estimates the process of diffusion and decay of knowledge from university, public laboratories and corporate patents in six countries and tests the differences across countries and across technological fields using data from the European Patent Office. It finds that university and public research patents are more cited relatively to companies’ patents. However these results are mainly driven by the Chemical, Drugs & Medical, and Mechanical fields and US universities. In Europe and Japan, where the great majority of patents from public research come from national agencies, there is no evidence of a superior fertility of university and public laboratory patents vis à vis corporate patents. The distribution of the citation lags shows that knowledge embedded in university and public research patents tends to diffuse more rapidly relative to corporate ones in particular in the US, Germany, France and Japan.

Exploring the Patent Explosion

This paper looks more closely at the sources of patent growth in the United States since 1984. It confirms that the increase is largely due to U.S. patenters, with an earlier surge in Asia, and some increase in Europe. Growth has taken place in all technologies, but not in all industries, being concentrated in the electrical, electronics, computing, and scientific instruments industries. It then examines whether these patents are valued by the market. We know from survey evidence that patents in these industries are not usually considered important for appropriability, but are sometimes considered necessary to secure financing for entering the industry. I compare the market value of patents held by entrant firms to those held by incumbents (controlling for R&D). Using data on publicly traded firms 1980--1989, I find that in industries based on electrical and mechanical technologies the market value of entrants' patents is positive in the post-1984 period (after the patenting surge), but not before, when patents were relatively unimportant in these industries. Also, the value of patent rights in complex product industries (where each product relies on many patents held by a number of other firms) is much higher for entrants than incumbents in the post-1984 period. For discrete product industries (where each product relies on only a few patents, and where the importance of patents for appropriability has traditionally been higher), there is no difference between incumbents and entrants.     

Idea generation: the performance of U.S. States 1997–2007

Regional prosperity increasingly depends on a region’s capacity to have command over the production of ideas. Measuring the production of ideas with patents, the objective of this paper is to analyze how the number of utility patents granted to inventors in U.S. States in different technologies changed between 1997 and 2007 and how States took advantage of the new opportunities and adapted to the changing technology landscape. The paper uses shift-share analysis, traditionally used in employment studies, for analyzing change in patents by technology categories developed by the NBER. The shift-share results show that only a few states were able to take advantage of the information technology driven increases in patents. California dominates in patent production and may be providing spillover benefits to neighboring states. The shift-share decompositions are used as variables in a fixed-effect panel-regression model of state economic growth. The regression results show that the shift-share decompositions provide statistically significant information in explaining growth after accounting for a State’s stock of patents, suggesting that States should concentrate on effective ways to boost their stock of knowledge in rapidly growing technologies to improve state economic growth.