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Delayed access to generic medicine: a comment on the Hatch-Waxman Act and the "approval bottleneck". 仿制药获得的延迟:对哈奇-韦克斯曼法案和“审批瓶颈”的评论。
IF 0.8 3区 社会学 Q2 Social Sciences Pub Date : 2009-11-01
Anjur N Patel

Prescription drug costs can be astronomical. The advent of generic drugs, which sell at substantially lower prices than their brand-name counterparts, can save consumers billions of dollars per year. The Hatch-Waxman Act, which governs the introduction of generic pharmaceuticals into the marketplace, produces an undesired side effect-the "approval bottleneck." This Comment examines the "approval bottleneck"-a potential roadblock to the generic drug approval process, and comments on attempts to alleviate the problem.This Comment suggests that developments in statutes and case law have made leaps in attempting to alleviate the "approval bottleneck" problem.The Comment evaluates these developments, which include (1) the ability of a subsequent Abbreviated New Drug Application (ANDA) filer to trigger the generic exclusivity period of the first ANDA filer; (2) the forfeiture provisions; (3) declaratory judgments and the relaxed declaratory judgment test; and (4) the rulings on covenants not to sue. Despite these attempts, however, the potential harm to consumers resulting from delayed access to generic medicines remains.

处方药的成本可能是天文数字。仿制药的出现,其售价大大低于品牌药,每年可以为消费者节省数十亿美元。哈奇-韦克斯曼法案(Hatch-Waxman Act)管理仿制药进入市场的过程,产生了一个不受欢迎的副作用——“审批瓶颈”。本评论探讨了“审批瓶颈”——仿制药审批过程的潜在障碍,并对缓解该问题的尝试提出了评论。本评论表明,成文法和判例法的发展在试图缓解“批准瓶颈”问题方面取得了飞跃。评论对这些进展进行了评估,其中包括:(1)后续简略新药申请(ANDA)申报者触发首个ANDA申报者的仿制药独占期的能力;(二)没收规定;(3)宣告性判决和宣告性判决放宽测试;(4)关于不起诉契约的裁决。然而,尽管有这些努力,延迟获得仿制药对消费者造成的潜在危害仍然存在。
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引用次数: 0
Love Thy Neighbor: Should Religious Accommodations that Negatively Affect Coworkers’ Shift Preferences Constitute an Undue Hardship on the Employer Under Title VII? 爱你的邻居:根据第七章,对同事轮班偏好产生负面影响的宗教住宿是否构成对雇主的过度困难?
IF 0.8 3区 社会学 Q2 Social Sciences Pub Date : 2009-09-13 DOI: 10.2139/SSRN.1472698
Rachel M. Birnbach
In applying Title VII, courts are often confronted with religious accommodations that would negatively affect other employees and are asked to decide whether such an accommodation amounts to an undue hardship on the employer. This Note explores the conflict among circuit courts concerning the scope of an employer’s duty to accommodate religious employees when doing so would negatively affect coworkers’ scheduling preferences, outside context of a collective bargaining agreement. This conflict turns on whether courts consider any negative impact on coworkers impermissible preferential treatment, or whether they require more severe impact on coworkers' rights be demonstrated. This Note argues that preferential treatment of the religious employee exists only when imposition on coworkers creates an economic burden on the employer or requires coworkers to take on additional, physically hazardous tasks.
在适用第七章时,法院经常面临会对其他雇员产生负面影响的宗教便利,并被要求决定这种便利是否构成对雇主的不当困难。这篇文章探讨了巡回法院之间关于雇主照顾宗教雇员的义务范围的冲突,当这样做会对同事的安排偏好产生负面影响时,在集体谈判协议的背景下。这一冲突取决于法院是否认为对同事的任何负面影响都是不允许的优惠待遇,或者他们是否需要证明对同事权利的更严重影响。本说明认为,对宗教雇员的优惠待遇只有在对同事的强加给雇主造成经济负担或要求同事承担额外的、身体上危险的任务时才存在。
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引用次数: 3
Ethical Visions of Copyright Law 著作权法的伦理视野
IF 0.8 3区 社会学 Q2 Social Sciences Pub Date : 2009-08-05 DOI: 10.31228/osf.io/zjtqv
James Grimmelmann
This symposium essay explores the imagined ethics of copyright: the ethical stories that people tell to justify, make sense of, and challenge copyright law. Such ethical visions are everywhere in intellectual property discourse, and legal scholarship ought to pay more attention to them. The essay focuses on a deontic vision of reciprocity in the author-audience relationship, a set of linked claims that authors and audiences ought to respect each other and express this respect through voluntary transactions. Versions of this default ethical vision animate groups as seemingly antagonistic as the music industry, file sharers, free software advocates, and Creative Commons. "Respect copyrights," "Don't sue your customers," "Software should be free," and "I love to share" are all ethical claims about copyright that share some common intuitions, even as they draw very different conclusions. The essay provides a framework for thinking about these ethical visions of intellectual property and then puts these various visions into conversation with each other.
这篇专题讨论会文章探讨了想象中的版权伦理:人们讲述的道德故事证明,使意义和挑战版权法。这种伦理愿景在知识产权话语中无处不在,法学研究应予以更多关注。这篇文章关注的是作者与读者关系中互惠的道义观,这是一系列相互关联的主张,即作者和读者应该相互尊重,并通过自愿交易来表达这种尊重。这种默认的道德愿景的不同版本,使音乐行业、文件共享者、自由软件倡导者和知识共享等看似对立的团体活跃起来。“尊重版权”、“不要起诉你的客户”、“软件应该是免费的”和“我喜欢分享”都是关于版权的道德主张,它们有一些共同的直觉,即使它们得出的结论非常不同。本文提供了一个思考这些知识产权伦理愿景的框架,然后将这些不同的愿景置于彼此的对话中。
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引用次数: 17
The Regulation of Creativity Under the WIPO Internet Treaties 世界知识产权组织互联网条约下的创造力管理
IF 0.8 3区 社会学 Q2 Social Sciences Pub Date : 2009-07-14 DOI: 10.2139/SSRN.1433848
Ruth L. Okediji
The WIPO Copyright Treaty and the WIPO Performances and Phonograms Treaty (WIPO Internet Treaties) recite a need for a digital copyright framework to facilitate 'adequate solutions to questions raised by new economic, social, cultural and technological developments.' It can hardly be contested that the social and cultural developments to which the Treaties refer do not derive from the cultural or economic conditions (much less technological developments) of the developing and least-developed countries. Consistent with their predecessors, the WIPO Internet Treaties marginalize collaborative forms of creative engagement with which citizens in the global South have long identified and continue in the tradition of assuming that copyright’s most enduring cannons are culturally neutral. Recently, however, the rise of Web 2.0 and the salience of new forms of creativity mediated by digital technologies and social networking sites have exposed structural tensions in copyright laws of OECD countries similar to those which developing countries have historically raised in opposition to the Berne Convention. This Essay reviews the evolution of the WIPO Internet Treaties and argues that the framework established just over a decade ago is increasingly less relevant in addressing the challenges of creativity in the digital age. The Treaties do not provide a meaningful basis for a harmonized approach to encourage new creative forms in much the same way the Berne Convention fell short of embracing diversity in patterns and modes of authorial expression. The growing social and legal recognition of new forms of creativity enabled through digital technologies offers an important opportunity to challenge anew claims that globally mandated copyright norms can effect incentives to create that are relevant across geographical, cultural and technological boundaries.
《世界知识产权组织版权条约》和《世界知识产权组织表演和录音制品条约》(《世界知识产权组织互联网条约》)指出,需要一个数字版权框架,以促进“充分解决新的经济、社会、文化和技术发展所提出的问题”。几乎无可争辩的是,条约所提到的社会和文化发展并非来自发展中国家和最不发达国家的文化或经济条件(更不用说技术发展)。与之前的条约一样,世界知识产权组织互联网条约将合作形式的创造性参与边缘化,而全球南方公民长期以来一直认同这种合作形式,并继续认为版权最持久的大炮在文化上是中立的。然而,最近,Web 2.0的兴起和以数字技术和社交网站为媒介的新形式的创造力的突出表现,暴露了经合组织国家版权法中的结构性紧张关系,类似于发展中国家在历史上反对《伯尔尼公约》时所提出的紧张关系。本文回顾了WIPO互联网条约的演变,并认为十多年前建立的框架在应对数字时代创造力的挑战方面越来越不相关。这些条约没有提供一个有意义的基础,以统一的方式鼓励新的创造性形式,就像《伯尔尼公约》没有包括作者表达方式和方式的多样性一样。社会和法律对通过数字技术实现的新形式的创造力的日益认可,提供了一个重要的机会,可以挑战新的说法,即全球授权的版权规范可以影响跨地域、文化和技术界限的创作激励。
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引用次数: 19
Adding insult to injury?: the untoward impact of requiring more than de minimis injury in an Eighth Amendment excessive force case. 雪上加霜?在第八修正案的过度使用武力案件中,要求超过轻微伤害的不利影响。
IF 0.8 3区 社会学 Q2 Social Sciences Pub Date : 2009-05-01
Robyn D Hoffman

This Note explores the conflict over whether a prisoner must suffer more than de minimis injury to sustain an Eighth Amendment excessive force claim. It examines this conflict against the backdrop of the various standards the U.S. Supreme Court adopted in its Eighth Amendment prison conditions jurisprudence between 1976 and 1992, principally focusing on the 1992 Hudson v. McMillian decision. Moreover, this Note considers the intersection of "the evolving standards of decency," the "hands-off doctrine," and the Eighth Amendment injury requirement. Ultimately, this Note advocates that excessive force--when meted out as punishment--violates the Eighth Amendment's prohibition on cruel and unusual punishment regardless of whether a prisoner's injuries are more than de minimis.

本说明探讨了囚犯是否必须遭受超过轻微伤害才能支持第八修正案过度使用武力的主张的冲突。本文以1976年至1992年间美国最高法院在其第八修正案监狱条件判例中采用的各种标准为背景,主要关注1992年哈德逊诉麦克米伦案的判决,考察了这一冲突。此外,本说明还考虑了“不断发展的得体标准”、“不干涉原则”和《第八修正案》伤害要求之间的交集。最后,本照会主张,过度使用武力——当作为惩罚时——违反了第八修正案禁止残忍和不寻常的惩罚的规定,无论囚犯的伤害是否超过了轻微程度。
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引用次数: 0
Beyond Lawrence v. Texas: crafting a fundamental right to sexual privacy. 超越劳伦斯诉德克萨斯州案:制定性隐私的基本权利。
IF 0.8 3区 社会学 Q2 Social Sciences Pub Date : 2009-05-01
Kristin Fasullo

After the watershed 2003 U.S. Supreme Court decision Lawrence v.Texas, courts are faced with the daunting task of navigating the bounds of sexual privacy in light of Lawrence's sweeping language and unconventional structure. This Note focuses on the specific issue of state governments regulating sexual device distribution. Evaluating the substantive due process rights of sexual device retailers and users, this Note ultimately argues that the privacy interest identified in Lawrence is sufficiently broad to protect intimate decisions to engage in adult consensual sexual behavior, including the liberty to sell, purchase, and use a sexual device.

在2003年美国最高法院对劳伦斯诉德克萨斯州案的分水岭判决之后,法院面临着一项艰巨的任务,即根据劳伦斯宽泛的语言和非传统的结构,在性隐私的界限上进行引导。本说明侧重于州政府规范性器具分发的具体问题。在评估性设备零售商和用户的实质性正当程序权利时,本报告最终认为,劳伦斯案中确定的隐私利益足够广泛,足以保护参与成人双方同意的性行为的亲密决定,包括出售、购买和使用性设备的自由。
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引用次数: 0
Combat veterans, mental health issues, and the death penalty: addressing the impact of post-traumatic stress disorder and traumatic brain injury. 打击退伍军人、心理健康问题和死刑:处理创伤后应激障碍和创伤性脑损伤的影响。
IF 0.8 3区 社会学 Q2 Social Sciences Pub Date : 2009-05-01
Anthony E Giardino

More than 1.5 million Americans have participated in combat operations in Iraq and Afghanistan over the past seven years. Some of these veterans have subsequently committed capital crimes and found themselves in our nation's criminal justice system. This Essay argues that combat veterans suffering from post-traumatic stress disorder or traumatic brain injury at the time of their offenses should not be subject to the death penalty.Offering mitigating evidence regarding military training, post-traumatic stress disorder, and traumatic brain injury presents one means that combat veterans may use to argue for their lives during the sentencing phase of their trials. Alternatively, Atkins v. Virginia and Roper v. Simmons offer a framework for establishing a legislatively or judicially created categorical exclusion for these offenders, exempting them from the death penalty as a matter of law. By understanding how combat service and service-related injuries affect the personal culpability of these offenders, the legal system can avoid the consequences of sentencing to death America's mentally wounded warriors, ensuring that only the worst offenders are subject to the ultimate punishment.

在过去七年中,有150多万美国人参加了在伊拉克和阿富汗的作战行动。其中一些退伍军人后来犯下了死罪,并发现自己进入了我们国家的刑事司法体系。本文认为,在犯罪时患有创伤后应激障碍或创伤性脑损伤的战斗退伍军人不应被判处死刑。提供有关军事训练、创伤后应激障碍和创伤性脑损伤的减刑证据是退伍军人在审判量刑阶段为自己的生命辩护的一种手段。另外,Atkins诉弗吉尼亚案和Roper诉Simmons案提供了一个框架,为这些罪犯建立立法或司法上的绝对排除,使他们在法律上免于死刑。通过了解战斗服务和与服务有关的伤害如何影响这些罪犯的个人罪责,法律体系可以避免判处美国精神受伤的战士死刑的后果,确保只有最严重的罪犯受到最终惩罚。
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引用次数: 0
Transferring innovation. 传递创新。
IF 0.8 3区 社会学 Q2 Social Sciences Pub Date : 2009-04-01
Jay P Kesan
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引用次数: 0
Notes on a Geography of Knowledge 《知识地理学笔记》
IF 0.8 3区 社会学 Q2 Social Sciences Pub Date : 2009-04-01 DOI: 10.17605/OSF.IO/NW4K3
M. J. Madison
Law and knowledge jointly occupy a metaphorical landscape. Understanding that landscape is essential to understanding the full complexity of knowledge law. This Article identifies some landmarks in that landscape, which it identifies as forms of legal practice: several recent cases involving intellectual property licenses, including the recent patent law decision in Quanta v. LG Electronics and the open source licensing decision in Jacobsen v. Katzer. The Article offers a preliminary framework for exploring the territories of knowledge practice in which those legal landmarks appear.
法律和知识共同占据了一个隐喻的景观。理解这一景观对于理解知识法则的全部复杂性至关重要。本文确定了这一领域的一些里程碑,并将其确定为法律实践的形式:最近几个涉及知识产权许可的案件,包括最近在广达诉LG电子案中的专利法裁决和Jacobsen诉Katzer案中的开源许可裁决。本文提供了一个初步的框架,以探索这些法律地标出现的知识实践领域。
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引用次数: 2
Assessing Fourth Amendment challenges to DNA extraction statutes after Samson v. California. 评估萨姆森诉加州案后第四修正案对DNA提取法规的挑战。
IF 0.8 3区 社会学 Q2 Social Sciences Pub Date : 2008-11-01
Charles J Nerko

DNA plays an indispensable role in modern law enforcement, and courts uniformly find that DNA extraction statutes targeting criminals satisfy the Fourth Amendment. Courts differ on which Fourth Amendment test--totality of the circumstances or special needs--ought to be employed in this context. This Note concludes that courts should apply Samson v. California's less stringent totality of the circumstances test to analyze DNA extraction statutes in order to maintain the integrity of the special needs test.

DNA在现代执法中发挥着不可或缺的作用,法院一致认为,针对罪犯的DNA提取法规符合第四修正案。在这种情况下,法院对第四修正案的标准——总体情况还是特殊需要——应该采用哪一种存在分歧。本说明的结论是,法院应应用Samson诉California案中较不严格的总体情况测试来分析DNA提取法规,以保持特殊需要测试的完整性。
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引用次数: 0
期刊
Fordham Law Review
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