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De Facto Parent and Nonparent Child Support Orders 事实父母和非父母子女抚养令
Pub Date : 2018-04-11 DOI: 10.31228/osf.io/rpx7w
Jeffrey A. Parness, M. Timko
For ever so long U.S. state laws have recognized the federal constitutional right to “care, custody and control” of a child vested in the opposite sex married couple who bore the child of sex or in any formal adoptive parent. More recently this parental right has also been recognized for the opposite sex unmarried couple who bore the child of sex. And even more recently, U.S. state laws have recognized this parental right for some who did not engage in the sex leading to birth and for some where the children were born without sex. State laws have also increasingly limited this childcare right by allowing nonparents to secure court-ordered childcare over the objections of established legal parents, whether by newly recognizing these nonparents as de facto parents or as third parties with childcare standing. While state childcare laws have evolved significantly as family structures, the availability of reliable and inexpensive genetic testing, and assisted reproduction techniques have changed, the laws on parental and nonparental child support have not changed much. This article is the first to explore actual and potential child support arising from the new childcare opportunities for both de facto parents and nonparents.
长期以来,美国各州的法律都承认联邦宪法赋予的“照顾、监护和控制”孩子的权利,这一权利属于生育了孩子的异性夫妇或任何正式的养父母。最近,这种父母的权利也被承认为异性未婚夫妇生下的孩子。甚至在最近,美国各州的法律也承认了一些没有发生性行为导致孩子出生的父母的权利,以及一些孩子出生时没有发生性行为的父母的权利。州法律也越来越多地限制了这种育儿权,允许非父母不顾法定父母的反对,获得法院命令的育儿权,无论是通过新承认这些非父母为事实上的父母,还是作为具有育儿资格的第三方。随着家庭结构、可靠而廉价的基因检测和辅助生殖技术的变化,各州的儿童保育法发生了重大变化,但有关父母和非父母子女抚养费的法律却没有太大变化。这篇文章是第一个探讨实际的和潜在的儿童抚养费产生的新托儿机会为事实上的父母和非父母。
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引用次数: 14
Two Sided Internet Markets and the Need to Assess Both Upstream and Downstream Impacts 双边互联网市场和评估上下游影响的必要性
Pub Date : 2018-03-01 DOI: 10.2139/SSRN.3139746
R. Frieden
This paper will explain how many information, communications and entertainment (“ICE”) markets support companies serving both downstream consumers, but also upstream ventures that access consumers primarily through an intermediary. Operating in a double-sided marketplace, intermediaries can achieve fast growth as they serve diverse geographical markets without having to erect or lease the telecommunications and information processing infrastructure needed to switch, route and deliver content to end users. ICE intermediaries also can expand quickly by accruing positive networking externalities as consumer welfare and incentives to subscribe increase. ICE platform operators have thrived in a largely deregulated marketplace with prospective regulation largely preempted by the view that consumers have benefitted without the need for government oversight. However, the court of public opinion may have begun to deviate from the view that platform operators present a universally positive value proposition. A proper assessment of consumer welfare balances downstream enhancements through convenience, cost savings, free-rider opportunities and innovation with upstream costs including the value of uncompensated consumer data collection, the viability and competitiveness of ICE ventures, e.g., newspapers, as well as the earnings, employability and stability of employees operating within the “gig economy.” The paper determines that many of the platform intermediaries most likely to harm consumers and competition have benefitted by a reluctance of government agencies to examine upstream impacts. Such reticence stems from legitimate concerns about over-reach, mission creep and jurisdiction. It also may represent prudent concerns that government not interfere and handicap successful ventures simply because their marketplace victories also trigger defeats. An emphasis on consumer impact steers agencies and reviewing courts toward a downstream emphasis, because consumers reside on that side of the double-sided market. On the other hand, the paper asserts that upside market assessments will become essential for a complete and statutory-compliant evidentiary record and thorough analysis. The paper will examine United States v. American Express Company, 838 F.3d 179 (2d Cir. 2016)(appeal pending), where an appellate court assessed both sides of a credit card issuer platform to determine the combined effects on consumers when an issuer tried to impose a contractual prohibition on merchants “steering” consumers to an alternative credit card offering lower processing fees to merchants. The lower court rejected the language as potentially raising consumer costs, without considering whether such terms might actually facilitate consumer benefits such as financial rebates. The paper concludes that double-sided markets require assessments of potential competitive and consumer harm occurring on both sides.
本文将解释有多少信息、通信和娱乐(“ICE”)市场既支持服务下游消费者的公司,也支持主要通过中介接触消费者的上游企业。在一个双边市场中运作,中介机构可以实现快速增长,因为它们服务于不同的地理市场,而不必建立或租赁电信和信息处理基础设施,以切换、路由和向最终用户交付内容。随着消费者福利和订阅激励的增加,ICE中介机构也可以通过积累积极的网络外部性来迅速扩张。ICE平台运营商在一个基本上放松管制的市场中蓬勃发展,由于消费者在不需要政府监督的情况下受益,预期的监管在很大程度上被先发制人。然而,舆论法庭可能已经开始偏离平台运营商提出普遍积极的价值主张的观点。对消费者福利的适当评估平衡了通过便利、成本节约、搭便车机会和创新来提高下游效益的上游成本,包括无偿收集消费者数据的价值、ICE企业(如报纸)的可行性和竞争力,以及在“零工经济”中运营的员工的收入、就业能力和稳定性。该论文认为,由于政府机构不愿审查上游影响,许多最有可能损害消费者和竞争的平台中介机构从中受益。这种沉默源于对越权、任务蔓延和管辖权的合理担忧。这也可能代表着谨慎的担忧,即政府不能仅仅因为成功的企业在市场上的胜利也会引发失败,就对其进行干预和阻碍。对消费者影响的强调引导了机构和审查法院对下游的强调,因为消费者居住在双面市场的那一边。另一方面,本文断言,上行市场评估将成为一个完整的、符合法律规定的证据记录和彻底分析的必要条件。本文将审查美国诉美国运通公司案,838 F.3d 179 (2d Cir. 2016)(上诉待审),其中上诉法院评估了信用卡发卡机构平台的双方,以确定当发卡机构试图对商家“引导”消费者使用向商家提供较低手续费的替代信用卡施加合同禁止时,对消费者的综合影响。下级法院驳回了这一措辞,因为它可能会提高消费者的成本,而没有考虑这些条款是否实际上会促进消费者的利益,比如金融回扣。本文的结论是,双边市场需要对双方发生的潜在竞争和消费者损害进行评估。
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引用次数: 3
The Fallacy of Choice: the Destructive Effect of School Vouchers on Children With Disabilities. 选择谬误:教育券对残疾儿童的破坏性影响。
Pub Date : 2018-01-01
Ian Farrell, Chelsea Marx

This Article addresses the impact of school voucher programs on students with disabilities. We show that for children with disabilities, the price of admission into so-called "school choice" programs is so high that it is effectively no realchoice at all. School voucher programs require students with disabilities to sign away their robust federal rights and protections in the public school system. Under the Individuals with Disabilities Education Act (IDEA)--the preeminentlegislative safeguard for students with disabilities--these rights include the right to a "free and appropriate public education" delivered through an "individualized education plan." By giving up these protections, children with disabilities are left at the mercy of private schools that have no legal obligation to provide them with an appropriate education, and, in the vast majority of cases, are not legally prohibited from discriminating against them on the basis of their disability. We argue that school voucher programs--including a proposed federal voucher program--put the education of students with disabilities back decades, and likely constitute a violation of the Equal Protection Clause of the U.S. Constitution.

本文讨论了学校代金券计划对残疾学生的影响。我们表明,对于残疾儿童来说,进入所谓的“择校”项目的费用如此之高,以至于实际上根本没有真正的选择。学校代金券计划要求残疾学生签字放弃他们在公立学校系统中强大的联邦权利和保护。根据《残疾人教育法》(individual with Disabilities Education Act,简称IDEA)——为残疾学生提供的重要立法保障——这些权利包括通过“个性化教育计划”接受“免费和适当的公共教育”的权利。如果放弃这些保护,残疾儿童就会任由私立学校摆布,这些学校没有法律义务为他们提供适当的教育,而且在绝大多数情况下,法律上也不禁止他们因残疾而受到歧视。我们认为,学校代金券计划——包括一项拟议的联邦代金券计划——使残疾学生的教育倒退了几十年,并且可能违反了美国宪法的平等保护条款。
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引用次数: 0
Inadequate Accessibility: Why Uber Should Be a Public Accommodation Under the Americans With Disabilities Act. 无障碍不足:为什么优步应该成为美国残疾人法案下的公共设施。
Pub Date : 2018-01-01
Elizabeth A Mapelli

This Comment will focus on Uber and its obligations under the Americans with Disabilities Act (ADA). While it may seem logical that Uber should adhere to the same ADA regulations as taxis, the relevant ADA provision only applies to private entities that are primarily engaged in the business of transporting people. To avoid these regulations, Uber asserts that it is primarily a technology company, rather than primarily a transportation company. However, the more expansive approach, consistent with the ADA's purpose of eliminating discrimination against persons with disabilities, is to classify Uber's services as public accommodations. While the ADA's public accommodation provision governs physical spaces such as restaurants, shopping centers, and offices, some jurisdictions have recently decided that web-based entities and services are public accommodations. Thus, even if a court were to accept Uber's claim that it is primarily a technology company rather than a transportation company, Uber would still be required to adhere to the ADA's public accommodation provision. This Comment presents and analyzes three rationales for defining Uber as a public accommodation under the ADA: (1) web-based activities are distinct public accommodations, (2) the physical vehicles that Uber operates are places of public accommodation, and (3) Uber is a "travel service" or "other service establishment" as defined in the ADA.

本评论将重点关注优步及其在《美国残疾人法案》(ADA)下的义务。虽然优步应该遵守与出租车相同的《美国残疾人法》规定似乎是合乎逻辑的,但《美国残疾人法》的相关规定只适用于主要从事运送人员业务的私人实体。为了避免这些规定,优步声称自己主要是一家科技公司,而不是一家运输公司。然而,与《美国残疾人法》消除对残疾人歧视的目的相一致的更广泛的方法是,将优步的服务归类为公共设施。虽然《美国残疾人法》的公共场所条款适用于餐馆、购物中心和办公室等实体空间,但一些司法管辖区最近决定,基于网络的实体和服务属于公共场所。因此,即使法院接受优步的说法,即优步主要是一家技术公司,而不是一家运输公司,优步仍将被要求遵守《美国残疾人法》的公共住宿条款。本评论提出并分析了根据《美国残疾人法》将优步定义为公共场所的三个理由:(1)基于网络的活动是不同的公共场所,(2)优步运营的实体车辆是公共场所,(3)优步是《美国残疾人法》定义的“旅行服务”或“其他服务机构”。
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引用次数: 0
The demise of drug design litigation: death by federal preemption. 药物设计诉讼的消亡:联邦政府先发制人的死亡。
Pub Date : 2018-01-01
Aaron D Twerski

For over half a century, courts and commentators have disagreed as to the standards governing liability for drug design cases. In the last several years, the United States Supreme Court decided two cases that will have a profound effect on whether drug design defect cases, in general, are federally preempted. In PLIVA v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, the Court preempted product liability actions for failure to warn and design defect against the manufacturers of generic drugs that met the FDA standard for the brand name drug. In these cases, the Court made wide-ranging statements that are applicable to brand name drugs as well. This Essay finds the Bartlett Court erred in having read New Hampshire law too narrowly. At the same time, the Court's reasoning has opened a debate as to the scope of federal preemption for brand name drugs. This Essay argues that the sweeping language in these two cases leads to the conclusion that common law drug design cases involving brand name drugs will fall prey to federal preemption.

半个多世纪以来,法院和评论家对药物设计案件的责任标准一直存在分歧。在过去的几年里,美国最高法院判决了两起案件,这两起案件将对药物设计缺陷案件是否在联邦法院优先审理产生深远影响。在PLIVA诉Mensing和Mutual Pharmaceutical Co.诉Bartlett一案中,法院对符合FDA品牌药标准的仿制药制造商因未能警告和设计缺陷而采取的产品责任诉讼进行了先发制人。在这些案件中,法院作出了广泛的声明,这些声明也适用于品牌药品。本文认为巴特利特法院错误地将新罕布什尔州的法律解读得过于狭隘。与此同时,最高法院的推理引发了一场关于联邦政府对品牌药品优先购买权范围的辩论。本文认为,在这两个案件中,笼统的语言导致的结论是,涉及品牌药物的普通法药物设计案件将成为联邦优先的牺牲品。
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引用次数: 0
Beyond Balancing: Rethinking the Law of Embryo Disposition. 超越平衡:对胚胎处置规律的再思考。
Pub Date : 2018-01-01
Mary Ziegler

Actress Sofia Vergara became the center of a new round of conflict about the disposition of embryos created using assisted reproductive technologies (ART): the conflict about the difference that abortion jurisprudence should make to case law on ART. This Article argues that the history of abortion jurisprudence sheds light on the problems with the leading approach to embryo-disposition cases like Vergara's. In many instances, courts first look for a clear, binding agreement and look to a balancing analysis if no such agreement exists. As this Article shows, this is not the first time that courts have applied a balancing analysis to deal with clashing rights to seek and avoid genetic parenthood. The Article explores the history of two balancing approaches that have played a pivotal role in abortion law. These approaches have led to inconsistent results and cater to the prejudices of judges who are asked to weigh the relative merits of individual parties' views on reproduction. This Article recommends that states adopt legislation detailing the requirements of an enforceable embryo disposition similar to the Uniform Premarital and Marital Agreements Act (UPMAA). In the embryo-disposition context, states should require parties to disclose legal rights and responsibilities rather than only finances. These disclosures should cover the preservation, implantation, or destruction of the embryos and the financial and legal responsibility for any resulting child. States should enforce an embryo-disposition agreement if it is voluntary, if the parties had counsel or the opportunity to access counsel, and if the parties had a full disclosure of the constitutional and common law rights implicated by the agreement.

女演员索菲亚·维加拉(Sofia Vergara)成为了新一轮关于处理使用辅助生殖技术(ART)产生的胚胎的冲突的中心:关于堕胎法理学应该对ART判例法做出区别的冲突。这篇文章认为,堕胎法理学的历史揭示了像维加拉这样的胚胎处置案件的主要方法的问题。在许多情况下,法院首先寻求一个明确的、有约束力的协议,如果不存在这样的协议,则寻求平衡分析。正如本文所示,这并不是法院第一次运用平衡分析来处理寻求和避免基因亲子关系的冲突权利。文章探讨了在堕胎法中发挥关键作用的两种平衡方法的历史。这些做法导致了不一致的结果,并迎合了法官的偏见,他们被要求权衡个别当事方关于生育的观点的相对优点。本文建议各州通过立法,详细说明可执行的胚胎处置的要求,类似于《统一婚前和婚姻协议法》(UPMAA)。在胚胎处置的背景下,各州应该要求当事人披露法律权利和责任,而不仅仅是财务状况。这些披露应包括胚胎的保存、植入或销毁,以及由此产生的孩子的经济和法律责任。如果胚胎处理协议是自愿的,如果当事方有律师或有机会接触律师,如果当事方充分披露了该协议所涉及的宪法和普通法权利,国家应执行该协议。
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引用次数: 0
Little Things and Big Challenges: Information Privacy and the Internet of Things 小事情和大挑战:信息隐私和物联网
Pub Date : 2017-06-01 DOI: 10.2139/SSRN.3188958
Hillary Brill, Scott Jones
IntroductionThe Internet of Things (IoT) is part of our lives in countless ways- some are welcome and intentional, such as trackable fitness devices, home security alert systems, or cars that can be unlocked and started remotely; others are unintentional and may cause concern to consumers, such as connected toys that can listen to our kids, or technologies capable of tracking our whereabouts or our shopping habits without our knowledge. The rapid growth of the IoT has prompted incredible technological advances along with thorny regulatory issues, specifically in the area of information privacy. Traditional regulators of privacy, specifically the Federal Trade Commission (FTC), have stretched to apply traditional tools to regulate unprecedented technological advances and the privacy challenges they bring. An analysis of the latest FTC cases and outcomes reveals an independent agency retooling investigative and enforcement methods and priorities to establish new expectations for how fair information practices and principles will be applied to new technologies.The FTC, like the technological advances it has stretched to keep pace with, has been increasingly progressive in its recent decision-making terminology. This Article uses recent, seminal FTC cases and outcomes to demonstrate how the FTC has developed a new information privacy framework, most recently expressed as the concept of "unfair tracking," by modifying traditional legal concepts. The FTC has significantly expanded its role as the primary reviewer of information privacy matters raised by the IoT, while attempting to balance a philosophy not to impede the advance of the technology comprising the IoT. This Article reviews recent FTC efforts to regulate the IoT and provides critical commentary on how the FTc might proceed.To best understand the genesis of recent FTC actions on IoT data collection, Part i describes what makes up the ioT, how pervasive the ioT has become in our lives and, perhaps most importantly, how it will continue to innovate at a rapid pace. Parts II and III of this Article describe some unprecedented benefits and unprecedented challenges confronting regulators of information privacy in today's IoT age, including how to protect individual privacy rights without undermining innovation and the promise the connected world of the IoT brings.Part IV provides an in-depth critical review of four key FTC cases attempting to strike this sort of balance: In re Nomi Technologies, Inc.,1 United States v. InMobi Pte Ltd..,2 In re Turn, Inc.,5 and FTC v. VlZIOi Initially, the FTC applied its traditional section 5 "deception" jurisprudence in a novel way to advance traditional notions of privacy, but it has recently transitioned to a new paradigm in the form of a cause of action for "unfair tracking," starting with VIZIO. However, this Article concludes that this new standard could prove either too anemic or, alternatively, overbroad, without proper shepherding by the FTC. It is only
物联网(IoT)以无数种方式成为我们生活的一部分——有些是受欢迎的,也是有意为之的,比如可追踪的健身设备、家庭安全警报系统,或者可以远程解锁和启动的汽车;还有一些是无意的,可能会引起消费者的担忧,比如可以听我们孩子说话的联网玩具,或者能够在我们不知情的情况下追踪我们的行踪或购物习惯的技术。物联网的快速发展带来了令人难以置信的技术进步,同时也带来了棘手的监管问题,特别是在信息隐私领域。传统的隐私监管机构,特别是联邦贸易委员会(FTC),已经开始运用传统工具来监管前所未有的技术进步及其带来的隐私挑战。对联邦贸易委员会最新案例和结果的分析表明,一个独立机构正在重新调整调查和执法方法和优先事项,以建立对如何将公平信息实践和原则应用于新技术的新期望。联邦贸易委员会,就像它一直在努力跟上技术进步的步伐一样,在最近的决策术语上也越来越进步。本文使用最近的、开创性的FTC案例和结果来展示FTC如何通过修改传统的法律概念来开发新的信息隐私框架,最近被表达为“不公平跟踪”的概念。公平交易委员会已经大大扩大了其作为物联网提出的信息隐私问题的主要审查者的作用,同时试图平衡一种不阻碍物联网技术进步的理念。本文回顾了联邦贸易委员会最近在监管物联网方面的努力,并就联邦贸易委员会可能如何进行提供了批判性的评论。为了更好地理解美国联邦贸易委员会最近在物联网数据收集方面采取的行动的起源,第一部分描述了物联网的组成,物联网在我们生活中的普及程度,也许最重要的是,它将如何继续快速创新。本文的第二部分和第三部分描述了当今物联网时代信息隐私监管机构面临的一些前所未有的好处和前所未有的挑战,包括如何在不损害创新和物联网互联世界带来的承诺的情况下保护个人隐私权。第四部分对试图达到这种平衡的四个关键FTC案例进行了深入的批判性审查:在re Nomi Technologies, Inc.,1 United States诉InMobi Pte Ltd.。最初,FTC以一种新颖的方式应用其传统的第5条“欺骗”法理学来推进传统的隐私概念,但它最近以“不公平跟踪”的诉因形式过渡到一种新的范式,从VIZIO开始。然而,本文的结论是,如果没有联邦贸易委员会的适当指导,这个新标准可能会被证明过于缺乏,或者过于宽泛。只有在积极主动的指导下,辅以传统的被动执法,物联网的小事才能克服物联网带来的巨大信息隐私挑战。物联网:小事物的大连接物联网(IoT)一词有各种各样的定义。从最广泛的意义上讲,这个短语“包括所有与互联网相连的东西,但它越来越多地被用来定义相互‘交谈’的对象。”物联网的一个简单定义是“基本上将任何具有开/关开关的设备连接到互联网(和/或彼此)的概念。”牛津词典将其定义为“嵌入日常物品中的计算设备通过互联网相互连接,使它们能够发送和接收数据。”另一些人将物联网定义为“一个设备通过无线数据基础设施连接到其他设备的能力”8或“植入传感器、软件和电子设备的设备和事物系统,以启动数据和信息的交换和收集。”...
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引用次数: 5
A Different Class of Care: the Benefits Crisis and Low-Wage Workers. 另一种关怀:福利危机和低薪工人。
Pub Date : 2017-01-01
Trina Jones

When compared to other developed nations, the United States fares poorly with regard to benefits for workers. While the situation is grim for most U.S. workers, it is worse for low-wage workers. Data show a significant benefits gap between low-wage and high-wage in terms of flexible work arrangements (FWAs), paid leave, pensions, and employer-sponsored health-care insurance, among other things. This gap exists notwithstanding the fact that FWAs and employment benefits produce positive returns for employees, employers, and society in general. Despite these returns, this Article contends that employers will be loath to extend FWAs and greater employment benefits to low-wage workers due to (1) concerns about costs, (2) a surplus of low-wage workers in the labor market, (3) negative perceptions of the skill of low-wage workers and the value of low-wage work, (4) other class-based stereotypes and biases, and (5) structural impediments in some low-wage jobs. Given the decline of unions and limited legislative action to date, the Article maintains that low-wage workers are in a "different class of care" with little hope for meaningful change on the horizon.

与其他发达国家相比,美国在工人福利方面表现不佳。虽然对大多数美国工人来说情况很严峻,但对低收入工人来说情况更糟。数据显示,在灵活工作安排、带薪休假、养恤金和雇主赞助的医疗保险等方面,低工资和高工资之间存在巨大的福利差距。尽管fwa和就业福利为雇员、雇主和整个社会带来了正回报,但这种差距仍然存在。尽管有这些回报,但本文认为,雇主将不愿向低薪工人提供fwa和更大的就业福利,因为(1)对成本的担忧,(2)劳动力市场上低薪工人的过剩,(3)对低薪工人技能和低薪工作价值的负面看法,(4)其他基于阶级的刻板印象和偏见,以及(5)一些低薪工作的结构性障碍。鉴于工会的衰落和迄今为止有限的立法行动,文章坚持认为,低工资工人处于“不同的护理阶层”,几乎没有希望在地平线上发生有意义的改变。
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引用次数: 0
"No Ordinary Lawsuit": Climate Change, Due Process, and the Public Trust Doctrine. “非普通诉讼”:气候变化、正当程序和公共信托原则。
Pub Date : 2017-01-01
Michael C Blumm, Mary Christina Wood

On November 10, 2016, just two days after the election of President Donald Trump, the federal district court in Oregon handed down Juliana v. United States. This remarkable decision refused to dismiss a lawsuit brought by youth plaintiffs who claimed that the federal government's fossil fuel policies over the years, which have produced an atmosphere with dangerous levels of greenhouse gases (GHGs), violated the federal public trust doctrine (PTD) and their federal constitutional rights to due process and equal protection. The court found a constitutional right to a stable climate system, determining that the PTD was an implicit part of due process and enforceable through the Constitution’s due process clause. At trial, if the youth plaintiffs are able to prove that for decades the government willfully disregarded information about the potential catastrophic effects of GHG pollution, or abdicated its public trust duties, the decision could be transformative in global efforts to shift to an energy policy that does not threaten young people and future generations. This Article examines Juliana, its context as part of a worldwide campaign of "atmospheric trust" litigation, its path-breaking reasoning, and its implications in the United States and abroad. The case has been described as "the case of the century" and, because of the harm it aims to address and the fundamental rights approach endorsed by the court, it just may be that. Pending the forthcoming trial and almost certain appeals, we think the case is, as the trial judge accurately recognized, "no ordinary lawsuit."

2016年11月10日,就在唐纳德·特朗普当选总统两天后,俄勒冈州联邦地方法院宣布了朱莉安娜诉美国案。这一引人注目的决定拒绝驳回一项由青年原告提起的诉讼,原告声称,联邦政府多年来的化石燃料政策导致大气中温室气体(GHGs)达到危险水平,违反了联邦公共信托原则(PTD)以及他们享有正当程序和平等保护的联邦宪法权利。法院认定稳定的气候系统是宪法赋予的权利,裁定PTD是正当程序的隐含部分,并可通过宪法的正当程序条款强制执行。在审判中,如果这些年轻的原告能够证明,几十年来,政府故意忽视了有关温室气体污染潜在灾难性影响的信息,或者放弃了其公共信托责任,那么这一决定可能会对全球转向不威胁年轻人和子孙后代的能源政策的努力产生革命性影响。本文考察了朱莉安娜案,它作为全球“大气信托”诉讼运动的一部分的背景,它的开创性推理,以及它在美国和国外的影响。该案件被描述为“世纪案件”,由于其旨在解决的危害以及法院认可的基本权利方法,它可能就是这样。在即将到来的审判和几乎肯定的上诉之前,我们认为,正如初审法官准确地认识到的那样,此案“不是普通的诉讼”。
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引用次数: 0
Using Data Exclusivity Grants to Incentivize Cumulative Innovation of Biologics' Manufacturing Processes. 利用数据独占权奖励激励生物制剂生产工艺的累积创新。
Pub Date : 2017-01-01
Eric Lawrence Levi

The pharmaceutical market is divided into two types of compounds: small-molecule chemical compounds and large-molecule biologics. Due to biologics’molecular sizes and the current scientific state of biologics manufacturing, manufacturing facilities and processes require frequent reassessment to ensureproduction of safe, pure, and potent therapeutics. Manufacturers utilize patent and drug regulatory law to protect their investments and simultaneously signal where innovation and investment are lacking. The current four- and twelve-year regimented structures of the Biologics Price, Competition, and Innovation Act do not keep pace with scientific development; biologics manufacturing processes drift with time, and if a manufacturer can obtain a higher degree of process control, then it should not feel restricted to wait until their exclusivity period lapses. Currently, the FDA rarely grants market exclusivity privileges for manufacturing process improvements alone; hence, manufacturing processes--or at least large portions thereof--are typically withheld as trade secrets or strategically claimed within companion composition claims. As a result, significant opportunity exists in regulatory framework to incentivize the research and development of biologics manufacturing processes. By creating a one- to four-year data exclusivity extension opportunity, manufacturers will feel more comfortable reinvesting their returns on investment towards manufacturing efficiency, and manufacturers can capitalize on the complex-molecule nature of their biologic.

医药市场分为两类化合物:小分子化合物和大分子生物制剂。由于生物制剂的分子大小和目前生物制剂生产的科学状况,生产设施和工艺需要经常重新评估,以确保安全、纯净和有效的治疗方法的再现。制造商利用专利和药品监管法律来保护他们的投资,同时也表明哪些地方缺乏创新和投资。现行的4年和12年的生物制品价格、竞争和创新法案没有跟上科学发展的步伐;生物制剂生产工艺随着时间的推移而变化,如果制造商能够获得更高程度的工艺控制,那么它就不应该感到受限于等待其独占期结束。目前,FDA很少单独授予生产工艺改进的市场专有权;因此,制造工艺-或至少其中的大部分-通常作为商业秘密或在伴侣组合物权利要求中战略性地要求。因此,在监管框架中存在重大机会,以激励生物制剂制造过程的研究和开发。通过创造一到四年的数据独占延长机会,制造商将更放心地将投资回报再投资于生产效率,制造商可以利用其生物制剂的复杂分子特性。
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The American University law review
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