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.
{"title":"Delayed access to generic medicine: a comment on the Hatch-Waxman Act and the \"approval bottleneck\".","authors":"Anjur N Patel","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2009-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28529181","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Love Thy Neighbor: Should Religious Accommodations that Negatively Affect Coworkers’ Shift Preferences Constitute an Undue Hardship on the Employer Under Title VII?","authors":"Rachel M. Birnbach","doi":"10.2139/SSRN.1472698","DOIUrl":"https://doi.org/10.2139/SSRN.1472698","url":null,"abstract":"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.","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2009-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2139/SSRN.1472698","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68184938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Ethical Visions of Copyright Law","authors":"James Grimmelmann","doi":"10.31228/osf.io/zjtqv","DOIUrl":"https://doi.org/10.31228/osf.io/zjtqv","url":null,"abstract":"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.","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2009-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"69641220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"The Regulation of Creativity Under the WIPO Internet Treaties","authors":"Ruth L. Okediji","doi":"10.2139/SSRN.1433848","DOIUrl":"https://doi.org/10.2139/SSRN.1433848","url":null,"abstract":"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.","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2009-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2139/SSRN.1433848","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68180983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Adding insult to injury?: the untoward impact of requiring more than de minimis injury in an Eighth Amendment excessive force case.","authors":"Robyn D Hoffman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2009-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28315963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Beyond Lawrence v. Texas: crafting a fundamental right to sexual privacy.","authors":"Kristin Fasullo","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2009-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28315961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Combat veterans, mental health issues, and the death penalty: addressing the impact of post-traumatic stress disorder and traumatic brain injury.","authors":"Anthony E Giardino","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2009-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28315959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Transferring innovation.","authors":"Jay P Kesan","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2009-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28164926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Notes on a Geography of Knowledge","authors":"M. J. Madison","doi":"10.17605/OSF.IO/NW4K3","DOIUrl":"https://doi.org/10.17605/OSF.IO/NW4K3","url":null,"abstract":"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.","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2009-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67653839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Assessing Fourth Amendment challenges to DNA extraction statutes after Samson v. California.","authors":"Charles J Nerko","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":47517,"journal":{"name":"Fordham Law Review","volume":null,"pages":null},"PeriodicalIF":0.8,"publicationDate":"2008-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"28100189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}