The FDA’s citizen petition process was created in the 1970s as part of an effort to fashion more participatory regimes, in which ordinary citizens could access the administrative process. The theoretical underpinnings hypothesize that a participatory structure will prevent regulatory agencies from being captured by the very industries they were intended to police. Anecdotal evidence suggests, however, that the FDA’s citizen petition process may have taken a different turn. This empirical study explores whether pharmaceutical companies are systematically using citizen petitions to try to delay the approval of generic competitors. Delaying generic entry of a drug — even by a few months — can be worth hundreds of millions of dollars of additional revenue, a cost ultimately borne by consumers and government agencies in the form of high drug prices. The study provides empirical evidence that the citizen petition process at the FDA has now become a key avenue for strategic behavior by pharmaceutical companies to delay entry of generic competition. It is a far cry from the “participatory citizen” notion that fueled the creation of such avenues at regulatory agencies. The article concludes by examining the nature of the problem and exploring the feasibility of three types of approaches to curb the behavior. These include: 1) a simple prohibition, if one were to conclude that most behavior in the category is likely to be inappropriate; 2) procedural blocks to ensure that the behavior cannot create sub-optimal results; or 3) punitive measures as a deterrent.
{"title":"Empirical Evidence of Drug Companies Using Citizen Petitions to Hold Off Competition","authors":"Robin C. Feldman, J. Gray, Giora Ashkenazi","doi":"10.2139/SSRN.3116986","DOIUrl":"https://doi.org/10.2139/SSRN.3116986","url":null,"abstract":"The FDA’s citizen petition process was created in the 1970s as part of an effort to fashion more participatory regimes, in which ordinary citizens could access the administrative process. The theoretical underpinnings hypothesize that a participatory structure will prevent regulatory agencies from being captured by the very industries they were intended to police. Anecdotal evidence suggests, however, that the FDA’s citizen petition process may have taken a different turn. This empirical study explores whether pharmaceutical companies are systematically using citizen petitions to try to delay the approval of generic competitors. Delaying generic entry of a drug — even by a few months — can be worth hundreds of millions of dollars of additional revenue, a cost ultimately borne by consumers and government agencies in the form of high drug prices. \u0000The study provides empirical evidence that the citizen petition process at the FDA has now become a key avenue for strategic behavior by pharmaceutical companies to delay entry of generic competition. It is a far cry from the “participatory citizen” notion that fueled the creation of such avenues at regulatory agencies. The article concludes by examining the nature of the problem and exploring the feasibility of three types of approaches to curb the behavior. These include: 1) a simple prohibition, if one were to conclude that most behavior in the category is likely to be inappropriate; 2) procedural blocks to ensure that the behavior cannot create sub-optimal results; or 3) punitive measures as a deterrent.","PeriodicalId":117505,"journal":{"name":"UC Hastings College of the Law Legal Studies Research Paper Series","volume":"22 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2018-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125286453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Public funders and private investors are pouring billions of dollars into Reducing Emissions from Deforestation and forest Degradation (REDD+) in the developing world. In REDD+, investors pay people to preserve carbon in trees, and then sell credits based on the stored carbon to those who wish to offset their own greenhouse gas emissions. REDD+ promises a dynamic synergism that mitigates climate change, conserves biodiversity, and alleviates poverty. When done poorly, however, REDD+ may dispossess already impoverished people from their sources of sustenance and may do little to mitigate climate change or conserve biodiversity. Including indigenous, forest-dependent, and other local people in all aspects of planning and implementing REDD+ is not only prudent practice — it is increasingly required by international law, and, I explain, is an essential ingredient in sustainable (effective, synergistic, and equitable) REDD+ Yet fulfilling these Environmental Democracy norms is nigh impossible in REDD+. What then? In this project, I review the current international legal status of Environmental Democracy, i.e., the right to participate in environmental decision making; the right to acquire information on environmental decisions; the right to redress and remedy when environmental rights are violated; and the right to Free Prior and Informed Consent when decisions are made that will affect vital resources and lands. I explain and expand current thinking of how the aspirational language of the principles ought to be implemented, and connect the principles’ relevance to REDD+, currently the most important laboratory for expanding Environmental Democracy in international conservation and development work. To illustrate how Environmental Democracy is or is not working in REDD+, I explore examples from Vietnam and Cambodia, where I conducted fieldwork in December 2012. I conclude that while stakeholders in REDD+ are making progress towards genuine Environmental Democracy, they have a ways to go to fulfill their legal and ethical obligations towards communities in which REDD+ is launching. After explaining why genuine Environmental Democracy in REDD+ is currently impracticable — and perhaps impossible — I conclude that REDD+’s promised benefits nonetheless justify carefully continuing it. I suggest how REDD+ project developers can fulfill the legal exigencies of Environmental Democracy, both as a matter of equity, and as a pragmatic approach to maximizing benefits for human and nonhuman communities.
{"title":"Environmental Democracy and Forest Carbon (REDD+)","authors":"D. Takács","doi":"10.2139/SSRN.2424286","DOIUrl":"https://doi.org/10.2139/SSRN.2424286","url":null,"abstract":"Public funders and private investors are pouring billions of dollars into Reducing Emissions from Deforestation and forest Degradation (REDD+) in the developing world. In REDD+, investors pay people to preserve carbon in trees, and then sell credits based on the stored carbon to those who wish to offset their own greenhouse gas emissions. REDD+ promises a dynamic synergism that mitigates climate change, conserves biodiversity, and alleviates poverty. When done poorly, however, REDD+ may dispossess already impoverished people from their sources of sustenance and may do little to mitigate climate change or conserve biodiversity. Including indigenous, forest-dependent, and other local people in all aspects of planning and implementing REDD+ is not only prudent practice — it is increasingly required by international law, and, I explain, is an essential ingredient in sustainable (effective, synergistic, and equitable) REDD+ Yet fulfilling these Environmental Democracy norms is nigh impossible in REDD+. What then? In this project, I review the current international legal status of Environmental Democracy, i.e., the right to participate in environmental decision making; the right to acquire information on environmental decisions; the right to redress and remedy when environmental rights are violated; and the right to Free Prior and Informed Consent when decisions are made that will affect vital resources and lands. I explain and expand current thinking of how the aspirational language of the principles ought to be implemented, and connect the principles’ relevance to REDD+, currently the most important laboratory for expanding Environmental Democracy in international conservation and development work. To illustrate how Environmental Democracy is or is not working in REDD+, I explore examples from Vietnam and Cambodia, where I conducted fieldwork in December 2012. I conclude that while stakeholders in REDD+ are making progress towards genuine Environmental Democracy, they have a ways to go to fulfill their legal and ethical obligations towards communities in which REDD+ is launching. After explaining why genuine Environmental Democracy in REDD+ is currently impracticable — and perhaps impossible — I conclude that REDD+’s promised benefits nonetheless justify carefully continuing it. I suggest how REDD+ project developers can fulfill the legal exigencies of Environmental Democracy, both as a matter of equity, and as a pragmatic approach to maximizing benefits for human and nonhuman communities.","PeriodicalId":117505,"journal":{"name":"UC Hastings College of the Law Legal Studies Research Paper Series","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2014-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117240961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
As reflected in the Federal Circuit’s fractured opinion in CLS Bank v. Alice Corp., there is no greater confusion in contemporary patent law than that surrounding the scope of patent eligibility limitations. This Supreme Court amicus brief in that case traces the roots of the court-made doctrines excluding patents on laws of nature, physical phenomena, and abstract ideas. It argues that a test of inventive application neither serves the underlying purposes of the patent system nor comports with the process of modern technological advance. As a result of advances in scientific understanding and methods over the past 150 years, many if not most inventions today explicate, manipulate, and control physical, chemical, biological, and digital phenomena at elemental, molecular, algorithmic, and systemic levels. Doctrines that treat conventional application of even newly discovered computer algorithms, molecular pathways, and chemical synthesis as unpatentable threaten to exclude much of the inventive thrust of modern research. Mayo’s requirement for unconventional application shifts scientists’ efforts from the valuable scientific and technological advances that society seeks toward surmounting an amorphous test of non-obvious implementation. Specific and practical application, in conjunction with the technological arts limitation explicated in Justice Stevens’s concurrence in Bilski, would better serve as the test for patent eligibility in the modern scientific and technological age.Particularly in light of past experience, setting inventive application as the test for patent eligibility threatens to undermine invention incentives, hamper patent prosecution, and greatly complicate patent litigation. While recognizing that the problems posed by patents on software and other computer-implemented inventions are real, this brief contends that patent eligibility doctrines beyond requiring specific application and categorical exclusion of business methods and other non-technological processes are poorly suited to address those concerns. It therefore concludes that the Supreme Court should turn away from the Funk Brothers/Flook/Mayo paradigm, and instead focus on elucidating the statutory requirements of patentability. By clarifying the constitutional and jurisprudential foundation for subject matter exclusions, the Court can promote legislative and administrative solutions that more directly address the evolving needs of the patent system.
{"title":"Rethinking Patent Eligibility for the Modern Scientific Age","authors":"Peter S. Menell, Jeffrey A. Lefstin","doi":"10.2139/SSRN.2402776","DOIUrl":"https://doi.org/10.2139/SSRN.2402776","url":null,"abstract":"As reflected in the Federal Circuit’s fractured opinion in CLS Bank v. Alice Corp., there is no greater confusion in contemporary patent law than that surrounding the scope of patent eligibility limitations. This Supreme Court amicus brief in that case traces the roots of the court-made doctrines excluding patents on laws of nature, physical phenomena, and abstract ideas. It argues that a test of inventive application neither serves the underlying purposes of the patent system nor comports with the process of modern technological advance. As a result of advances in scientific understanding and methods over the past 150 years, many if not most inventions today explicate, manipulate, and control physical, chemical, biological, and digital phenomena at elemental, molecular, algorithmic, and systemic levels. Doctrines that treat conventional application of even newly discovered computer algorithms, molecular pathways, and chemical synthesis as unpatentable threaten to exclude much of the inventive thrust of modern research. Mayo’s requirement for unconventional application shifts scientists’ efforts from the valuable scientific and technological advances that society seeks toward surmounting an amorphous test of non-obvious implementation. Specific and practical application, in conjunction with the technological arts limitation explicated in Justice Stevens’s concurrence in Bilski, would better serve as the test for patent eligibility in the modern scientific and technological age.Particularly in light of past experience, setting inventive application as the test for patent eligibility threatens to undermine invention incentives, hamper patent prosecution, and greatly complicate patent litigation. While recognizing that the problems posed by patents on software and other computer-implemented inventions are real, this brief contends that patent eligibility doctrines beyond requiring specific application and categorical exclusion of business methods and other non-technological processes are poorly suited to address those concerns. It therefore concludes that the Supreme Court should turn away from the Funk Brothers/Flook/Mayo paradigm, and instead focus on elucidating the statutory requirements of patentability. By clarifying the constitutional and jurisprudential foundation for subject matter exclusions, the Court can promote legislative and administrative solutions that more directly address the evolving needs of the patent system.","PeriodicalId":117505,"journal":{"name":"UC Hastings College of the Law Legal Studies Research Paper Series","volume":"124 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2014-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122482704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Public attention is increasingly focused on patent monetization entities. Known colloquially as “patent trolls,” these entities derive income from licensing or litigating, rather than producing a product. To understand the impact of these entities, we examined all patent litigations filed across four years, 2007-2008 and 2011-2012. This involved analyzing almost 13,000 cases and almost 30,000 patents asserted. Most striking, as of 2012, litigation by patent monetization entities now represents a majority of the patent litigations filed in the United States. In fact, 58.7% of all patent lawsuits were filed by monetizers. This is a sharp rise from 2007, when monetizers filed only 24.6%. In addition, of the parties who filed the greatest number of patent litigations in the years we studied, all 10 are monetizers.We also examined the age and transfer patterns of the patents asserted. Among other findings, we saw that the newest patents issued are the ones most frequently litigated. This could suggest that people are increasingly applying for patents with the intent of filing lawsuits, rather than making products.Our analysis also revealed a problem previously unrecognized. Mechanisms for notifying the public when patents have been asserted in lawsuits are woefully inadequate. Current mechanisms did not operate 2/3 of the time. The study also found indications of stealth behavior, as well as a market for purchasing patents after they expire.
{"title":"The AIA 500 Expanded: The Effects of Patent Monetization Entities","authors":"Robin C. Feldman, Thomas Ewing, Sara Jeruss","doi":"10.2139/SSRN.2247195","DOIUrl":"https://doi.org/10.2139/SSRN.2247195","url":null,"abstract":"Public attention is increasingly focused on patent monetization entities. Known colloquially as “patent trolls,” these entities derive income from licensing or litigating, rather than producing a product. To understand the impact of these entities, we examined all patent litigations filed across four years, 2007-2008 and 2011-2012. This involved analyzing almost 13,000 cases and almost 30,000 patents asserted. Most striking, as of 2012, litigation by patent monetization entities now represents a majority of the patent litigations filed in the United States. In fact, 58.7% of all patent lawsuits were filed by monetizers. This is a sharp rise from 2007, when monetizers filed only 24.6%. In addition, of the parties who filed the greatest number of patent litigations in the years we studied, all 10 are monetizers.We also examined the age and transfer patterns of the patents asserted. Among other findings, we saw that the newest patents issued are the ones most frequently litigated. This could suggest that people are increasingly applying for patents with the intent of filing lawsuits, rather than making products.Our analysis also revealed a problem previously unrecognized. Mechanisms for notifying the public when patents have been asserted in lawsuits are woefully inadequate. Current mechanisms did not operate 2/3 of the time. The study also found indications of stealth behavior, as well as a market for purchasing patents after they expire.","PeriodicalId":117505,"journal":{"name":"UC Hastings College of the Law Legal Studies Research Paper Series","volume":"42 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2013-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128694891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
As healthcare expenditures continue to climb, politicians, business leaders, and patients avidly search for new methods to reduce healthcare costs. In an eleven-point plan released this summer, a group of the nation’s top healthcare experts listed “full transparency of prices” as one potential solution to reduce healthcare costs. The experts, some of whom helped write the Patient Protection and Affordable Care Act, argued that price transparency would allow consumers to compare prices before choosing a provider or hospital and, consequently, better anticipate their overall costs. In turn, they argued that making price information publicly accessible would also reduce excess healthcare spending by encouraging providers to offer more competitive pricing. Other health services research, however, suggests that legislative and regulatory efforts to promote price transparency may result in increased healthcare costs depending on the market conditions and the various stakeholders targeted. Consequently, any price transparency initiative must not only make prices transparent, but also account for the differences between markets, either by reducing the economic inefficiencies that keep price transparency from being effective or by targeting only the specific regions where the market would support such an initiative. This article analyzes whether price transparency initiatives can be effectively used to reduce healthcare costs, and if so, what conditions must be met for them to do so. The features of a well-designed price transparency initiative will vary depending upon the targeted population (patients, employers, providers, or insurers) and the particular features of the target market. We argue that the most effective solutions will mandate disclosure of price and quality information at the appropriate stakeholder levels and, simultaneously, break down provider market leverage where it prevents price transparency from helping consumers. Together, these two elements have the potential to lower healthcare costs. Finally, we present four possible price transparency initiatives that represent a range of possible avenues to promoting effective price transparency including litigation, legislation, regulation, and consumer driven initiatives.
随着医疗保健支出的持续攀升，政界人士、商界领袖和患者都在热切地寻找降低医疗保健成本的新方法。在今年夏天发布的11点计划中，一群国家顶级医疗保健专家将“价格完全透明”列为降低医疗保健成本的一个潜在解决方案。这些专家中的一些人曾帮助撰写《患者保护和平价医疗法案》(Patient Protection and Affordable Care Act)。他们认为，价格透明将允许消费者在选择供应商或医院之前比较价格，从而更好地预测他们的总体成本。反过来，他们认为，公开价格信息也会鼓励供应商提供更具竞争力的价格，从而减少多余的医疗支出。然而，其他保健服务研究表明，促进价格透明度的立法和监管努力可能导致保健费用增加，这取决于市场条件和所针对的各种利益攸关方。因此，任何价格透明度倡议不仅必须使价格透明，而且还必须考虑到市场之间的差异，要么通过减少阻碍价格透明度发挥作用的经济低效，要么只针对市场支持这种倡议的特定地区。本文分析了价格透明度举措是否可以有效地用于降低医疗保健成本，如果可以，必须满足哪些条件才能这样做。精心设计的价格透明计划的特征将根据目标人群(患者、雇主、提供者或保险公司)和目标市场的特定特征而有所不同。我们认为，最有效的解决方案将强制要求在适当的利益相关者层面披露价格和质量信息，同时打破供应商的市场杠杆，因为它阻碍了价格透明度对消费者的帮助。这两个因素加在一起有可能降低医疗保健成本。最后，我们提出了四种可能的价格透明度举措，它们代表了促进有效价格透明度的一系列可能途径，包括诉讼、立法、监管和消费者驱动的举措。
{"title":"Clarifying Costs: Can Increased Price Transparency Reduce Healthcare Spending?","authors":"M. Muir, Stephanie A. Alessi, Jaime S. King","doi":"10.2139/ssrn.2224151","DOIUrl":"https://doi.org/10.2139/ssrn.2224151","url":null,"abstract":"As healthcare expenditures continue to climb, politicians, business leaders, and patients avidly search for new methods to reduce healthcare costs. In an eleven-point plan released this summer, a group of the nation’s top healthcare experts listed “full transparency of prices” as one potential solution to reduce healthcare costs. The experts, some of whom helped write the Patient Protection and Affordable Care Act, argued that price transparency would allow consumers to compare prices before choosing a provider or hospital and, consequently, better anticipate their overall costs. In turn, they argued that making price information publicly accessible would also reduce excess healthcare spending by encouraging providers to offer more competitive pricing. Other health services research, however, suggests that legislative and regulatory efforts to promote price transparency may result in increased healthcare costs depending on the market conditions and the various stakeholders targeted. Consequently, any price transparency initiative must not only make prices transparent, but also account for the differences between markets, either by reducing the economic inefficiencies that keep price transparency from being effective or by targeting only the specific regions where the market would support such an initiative. This article analyzes whether price transparency initiatives can be effectively used to reduce healthcare costs, and if so, what conditions must be met for them to do so. The features of a well-designed price transparency initiative will vary depending upon the targeted population (patients, employers, providers, or insurers) and the particular features of the target market. We argue that the most effective solutions will mandate disclosure of price and quality information at the appropriate stakeholder levels and, simultaneously, break down provider market leverage where it prevents price transparency from helping consumers. Together, these two elements have the potential to lower healthcare costs. Finally, we present four possible price transparency initiatives that represent a range of possible avenues to promoting effective price transparency including litigation, legislation, regulation, and consumer driven initiatives.","PeriodicalId":117505,"journal":{"name":"UC Hastings College of the Law Legal Studies Research Paper Series","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2013-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134564860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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