Pub Date : 2023-05-24DOI: 10.52214/stlr.v24i2.11627
Frederick Abbott
Prosecution of pharmaceutical companies for excessive pricing of products under competition law is now a reality. As recently as a decade ago, such prosecutions were virtually nonexistent. That situation has changed dramatically as competition authorities in Europe and South Africa have pursued a significant number of such prosecutions and have levied substantial fines against the
investigated parties. While the United States has traditionally led in policing the pharmaceutical market against anticompetitive misconduct, in this specific arena it has fallen behind, principally because federal courts so far have refused to acknowledge excessive pricing as a cause of action under Section 2 of the Sherman Act.
In a succession of cases European competition authorities have demonstrated concretely the way in which excessive pricing prosecutions may be pursued. This article examines those cases in some detail showing the challenges that competition authorities have faced, and how they have gone about addressing them. The successes in Europe should help put to rest arguments regarding the difficulties in ascertaining how pharmaceutical products are priced, particularly for products no longer covered by patents or regulatory market exclusivity. The South African competition authority is undertaking its second major prosecution of excessive pricing of originator products. The ongoing case involves an essential anticancer medicine the pricing of which has deprived individuals in South Africa of life-saving treatment.
Methodologies for investigating and analyzing abusive pricing are being regularized. This is important because competition authorities around the world should be able to rely on generally accepted standards for pursuing misconduct. This article suggests doctrinal improvements in the form of per se baseline rules for establishing excess with respect to generics, and rule of reason balancing tests for assessing the fairness of pricing practices for originator products and generics not encompassed by per se rules. The continued evolution of excessive pricing doctrine does not depend on these improvements. More important is continuing legal, financial, and political support for the efforts of competition authorities in this area.
Patents, regulatory market exclusivity and other structural features insulate the pharmaceutical market from economic pressures that ordinarily create and recreate an equilibrium that protects consumers. For the pharmaceutical market, there must be a means to redress excessive prices in themselves. Competition law enforcement is an important tool for achieving that redress.
{"title":"Prosecuting Excessive Pricing of Pharmaceuticals Under Competition Law","authors":"Frederick Abbott","doi":"10.52214/stlr.v24i2.11627","DOIUrl":"https://doi.org/10.52214/stlr.v24i2.11627","url":null,"abstract":"Prosecution of pharmaceutical companies for excessive pricing of products under competition law is now a reality. As recently as a decade ago, such prosecutions were virtually nonexistent. That situation has changed dramatically as competition authorities in Europe and South Africa have pursued a significant number of such prosecutions and have levied substantial fines against the
 investigated parties. While the United States has traditionally led in policing the pharmaceutical market against anticompetitive misconduct, in this specific arena it has fallen behind, principally because federal courts so far have refused to acknowledge excessive pricing as a cause of action under Section 2 of the Sherman Act.
 
 In a succession of cases European competition authorities have demonstrated concretely the way in which excessive pricing prosecutions may be pursued. This article examines those cases in some detail showing the challenges that competition authorities have faced, and how they have gone about addressing them. The successes in Europe should help put to rest arguments regarding the difficulties in ascertaining how pharmaceutical products are priced, particularly for products no longer covered by patents or regulatory market exclusivity. The South African competition authority is undertaking its second major prosecution of excessive pricing of originator products. The ongoing case involves an essential anticancer medicine the pricing of which has deprived individuals in South Africa of life-saving treatment.
 
 Methodologies for investigating and analyzing abusive pricing are being regularized. This is important because competition authorities around the world should be able to rely on generally accepted standards for pursuing misconduct. This article suggests doctrinal improvements in the form of per se baseline rules for establishing excess with respect to generics, and rule of reason balancing tests for assessing the fairness of pricing practices for originator products and generics not encompassed by per se rules. The continued evolution of excessive pricing doctrine does not depend on these improvements. More important is continuing legal, financial, and political support for the efforts of competition authorities in this area.
 
 Patents, regulatory market exclusivity and other structural features insulate the pharmaceutical market from economic pressures that ordinarily create and recreate an equilibrium that protects consumers. For the pharmaceutical market, there must be a means to redress excessive prices in themselves. Competition law enforcement is an important tool for achieving that redress.
 
","PeriodicalId":87208,"journal":{"name":"The Columbia science and technology law review","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135138908","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}
Pub Date : 2023-05-23DOI: 10.52214/stlr.v24i2.11630
John Thomas
Patents take the form of public letters that the U.S. Patent and Trademark Office (USPTO) actively disseminates. Whether these documents sufficiently provide the public with notice of the technologies they describe, as well as the proprietary rights that they assert, has been subject to long-standing debate. Many commentators conclude that patents are often filed too early in the research and development cycle, are deliberately drafted in a vague or obtuse manner, or are simply too numerous. As a result, identifying the relevant patent landscape is not just difficult for technology implementers, but possibly undesirable as a matter of innovation policy. Yet prior scholarship has seldom acknowledged current statutory mechanisms to improve the notice function of patents after they issue. This Article endeavors to fill that gap. Congress has long encouraged intellectual property rights holders to identify their patents on the products they sell. Patent marking has traditionally occurred on physical products or their packaging, although it has been recently extended to Internet-based virtual marking. The marking statute stipulates that patent proprietors that fail to mark face severe remedial restrictions when challenging infringers. Congress has assigned the Food & Drug Administration (FDA) a part in providing patent notice as well. In keeping with federal legislation, the agency maintains two publications, commonly known as the Orange and Purple Books, that act as a patent clearinghouse for approved drugs and licensed biologics. The role of a patent within the marketplace provides perhaps the most valuable form of notice that that instrument may offer. Yet the marking statute and FDA publications suffer from some apparent flaws. In combination they project a failure to identify all patents that are relevant to the product, favor patent trolls, involve dubious practical workings, promote misleading advertising, and impose punitive sanctions in comparison to the notice requirements of peer intellectual property rights. For its part, the FDA has proven an untutored and unreliable patent publicist for the past four decades. This Article offers specific suggestions to improve the notice functions of patents after they issue. It calls for the USPTO to develop and populate its own virtual marking database that correlates individual patents with the marketplace. It also encourages the FDA to take further steps to counter abuses of the Orange and Purple Books and to accelerate their patent notice functions. Finally, this Article takes broader lessons from this effort, offering pathways for policymakers to look beyond the patent instrument as they endeavor to improve the patent system’s notice functions.
{"title":"Noticing Patents","authors":"John Thomas","doi":"10.52214/stlr.v24i2.11630","DOIUrl":"https://doi.org/10.52214/stlr.v24i2.11630","url":null,"abstract":"Patents take the form of public letters that the U.S. Patent and Trademark Office (USPTO) actively disseminates. Whether these documents sufficiently provide the public with notice of the technologies they describe, as well as the proprietary rights that they assert, has been subject to long-standing debate. Many commentators conclude that patents are often filed too early in the research and development cycle, are deliberately drafted in a vague or obtuse manner, or are simply too numerous. As a result, identifying the relevant patent landscape is not just difficult for technology implementers, but possibly undesirable as a matter of innovation policy. Yet prior scholarship has seldom acknowledged current statutory mechanisms to improve the notice function of patents after they issue. This Article endeavors to fill that gap. \u0000Congress has long encouraged intellectual property rights holders to identify their patents on the products they sell. Patent marking has traditionally occurred on physical products or their packaging, although it has been recently extended to Internet-based virtual marking. The marking statute stipulates that patent proprietors that fail to mark face severe remedial restrictions when challenging infringers. Congress has assigned the Food & Drug Administration (FDA) a part in providing patent notice as well. In keeping with federal legislation, the agency maintains two publications, commonly known as the Orange and Purple Books, that act as a patent clearinghouse for approved drugs and licensed biologics. \u0000The role of a patent within the marketplace provides perhaps the most valuable form of notice that that instrument may offer. Yet the marking statute and FDA publications suffer from some apparent flaws. In combination they project a failure to identify all patents that are relevant to the product, favor patent trolls, involve dubious practical workings, promote misleading advertising, and impose punitive sanctions in comparison to the notice requirements of peer intellectual property rights. For its part, the FDA has proven an untutored and unreliable patent publicist for the past four decades. \u0000This Article offers specific suggestions to improve the notice functions of patents after they issue. It calls for the USPTO to develop and populate its own virtual marking database that correlates individual patents with the marketplace. It also encourages the FDA to take further steps to counter abuses of the Orange and Purple Books and to accelerate their patent notice functions. Finally, this Article takes broader lessons from this effort, offering pathways for policymakers to look beyond the patent instrument as they endeavor to improve the patent system’s notice functions.","PeriodicalId":87208,"journal":{"name":"The Columbia science and technology law review","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77184125","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}
Pub Date : 2023-05-23DOI: 10.52214/stlr.v24i2.11629
Sea-hoon Kwon
The rise of intermediary-less decentralized finance (“DeFi”) lending has led many to wonder how it should be regulated. Although DeFi lending could potentially offer reduced risks of centralization and market frictions, investors in DeFi lending are currently exposed to centralized risks and losses in the volatile market in the absence of regulation. The SEC suggested that the agency might regulate the sector under the federal securities laws. A truly decentralized lending project, however, does not involve any centralized entity that could carry the burden of compliance with the securities laws. This Note shows that many DeFi lending projects are not truly decentralized and are in various stages of decentralization. Unlike P2P lenders and financial intermediaries that bear the costs of compliance, many DeFi developers seek to build automated lending systems and gradually relinquish their control over their creation. However, with the lack of regulation, the investors have no means to tell actors who seek to build secure decentralized systems from those who do not in the early stage of DeFi protocol development. To address the issue, this Note proposes a three-part framework that would oversee the process of decentralization for DeFi lending projects, drawing its structure from the U.S. banking regulation focused on supervision. First, the framework recognizes the value of decentralization in reducing market frictions and risks of centralization. Second, the framework establishes a federal agency that oversees the process of decentralization on the flexible safety and soundness standard of Glass-Steagall Act. Third, the framework grants enforcement powers to the federal agency to sanction DeFi platforms that do not comply with government regulations.
{"title":"Regulation of DeFi Lending","authors":"Sea-hoon Kwon","doi":"10.52214/stlr.v24i2.11629","DOIUrl":"https://doi.org/10.52214/stlr.v24i2.11629","url":null,"abstract":"The rise of intermediary-less decentralized finance (“DeFi”) lending has led many to wonder how it should be regulated. Although DeFi lending could potentially offer reduced risks of centralization and market frictions, investors in DeFi lending are currently exposed to centralized risks and losses in the volatile market in the absence of regulation. The SEC suggested that the agency might regulate the sector under the federal securities laws. A truly decentralized lending project, however, does not involve any centralized entity that could carry the burden of compliance with the securities laws. This Note shows that many DeFi lending projects are not truly decentralized and are in various stages of decentralization. Unlike P2P lenders and financial intermediaries that bear the costs of compliance, many DeFi developers seek to build automated lending systems and gradually relinquish their control over their creation. However, with the lack of regulation, the investors have no means to tell actors who seek to build secure decentralized systems from those who do not in the early stage of DeFi protocol development. To address the issue, this Note proposes a three-part framework that would oversee the process of decentralization for DeFi lending projects, drawing its structure from the U.S. banking regulation focused on supervision. First, the framework recognizes the value of decentralization in reducing market frictions and risks of centralization. Second, the framework establishes a federal agency that oversees the process of decentralization on the flexible safety and soundness standard of Glass-Steagall Act. Third, the framework grants enforcement powers to the federal agency to sanction DeFi platforms that do not comply with government regulations.","PeriodicalId":87208,"journal":{"name":"The Columbia science and technology law review","volume":"61 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84886801","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}
Pub Date : 2023-05-23DOI: 10.52214/stlr.v24i2.11631
B. Hewitt
Remote workers are subjected to constant and intrusive surveillance by employers and health technology companies. Working from home became commonplace as a result of COVID-19, and increasingly employers use health and location tracking software, as well as webcams and facial recognition, to monitor their employees. This surveillance exacerbates risks of discrimination based on health data and other lifestyle factors that have no bearing on work performance, implicates the privacy rights of family members and roommates, and sharpens the power asymmetry between employers and employees. Particularly as States seek to criminalize women seeking abortions following the Supreme Court’s overturning of Roe v. Wade, the safeguarding of health data on fertility-tracking applications has never been more important. Given the novelty and rapidity of this transition, state and federal laws fall short of adequately protecting remote workers from incessant surveillance, particularly of their health data. Although several federal laws and agencies appear to address certain aspects of this threat, in practice laws such as HIPAA at the federal level and BIPA and CCPA in Illinois and California, respectively, do not sufficiently regulate the collection of health data from remote workers. In addition to these practical issues, U.S. privacy law generally places undue exclusive emphasis on the individual, relying on notice-and-consent provisions and anonymization. However, the case of remote worker surveillance highlights the deficiencies of this individualized focus. This Note details the prevalence and harm of remote worker surveillance, discusses how the current data privacy legal regime falls short, and offers proposals for strengthening privacy protections for remote workers and their health data.
远程工作者受到雇主和医疗技术公司持续的侵入性监视。由于2019冠状病毒病，在家工作变得司空见惯，越来越多的雇主使用健康和位置跟踪软件，以及网络摄像头和面部识别来监控员工。这种监视加剧了基于健康数据和其他与工作表现无关的生活方式因素的歧视风险，涉及家庭成员和室友的隐私权，并加剧了雇主和雇员之间的权力不对称。特别是在最高法院推翻罗伊诉韦德案(Roe v. Wade)后，各州试图将寻求堕胎的妇女定为刑事犯罪，保护生育跟踪应用程序的健康数据从未像现在这样重要。鉴于这种转变的新颖性和快速性，州和联邦法律未能充分保护远程工作者免受不间断的监视，特别是他们的健康数据。尽管一些联邦法律和机构似乎解决了这一威胁的某些方面，但在实践中，诸如联邦一级的HIPAA以及伊利诺伊州和加利福尼亚州的BIPA和CCPA等法律并没有充分规范远程工作人员健康数据的收集。除了这些实际问题之外，美国隐私法通常过分强调个人，依赖于通知同意条款和匿名化。然而，远程工作人员监控的案例突出了这种个性化关注的缺陷。本说明详细介绍了远程工作人员监控的普遍性和危害，讨论了当前数据隐私法律制度的不足之处，并提出了加强对远程工作人员及其健康数据的隐私保护的建议。
{"title":"Panoptic Employment","authors":"B. Hewitt","doi":"10.52214/stlr.v24i2.11631","DOIUrl":"https://doi.org/10.52214/stlr.v24i2.11631","url":null,"abstract":"Remote workers are subjected to constant and intrusive surveillance by employers and health technology companies. Working from home became commonplace as a result of COVID-19, and increasingly employers use health and location tracking software, as well as webcams and facial recognition, to monitor their employees. This surveillance exacerbates risks of discrimination based on health data and other lifestyle factors that have no bearing on work performance, implicates the privacy rights of family members and roommates, and sharpens the power asymmetry between employers and employees. Particularly as States seek to criminalize women seeking abortions following the Supreme Court’s overturning of Roe v. Wade, the safeguarding of health data on fertility-tracking applications has never been more important. \u0000Given the novelty and rapidity of this transition, state and federal laws fall short of adequately protecting remote workers from incessant surveillance, particularly of their health data. Although several federal laws and agencies appear to address certain aspects of this threat, in practice laws such as HIPAA at the federal level and BIPA and CCPA in Illinois and California, respectively, do not sufficiently regulate the collection of health data from remote workers. In addition to these practical issues, U.S. privacy law generally places undue exclusive emphasis on the individual, relying on notice-and-consent provisions and anonymization. However, the case of remote worker surveillance highlights the deficiencies of this individualized focus. This Note details the prevalence and harm of remote worker surveillance, discusses how the current data privacy legal regime falls short, and offers proposals for strengthening privacy protections for remote workers and their health data.","PeriodicalId":87208,"journal":{"name":"The Columbia science and technology law review","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79785191","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}
Pub Date : 2023-05-23DOI: 10.52214/stlr.v24i2.11628
S. Falati
The Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112 has selectively and severely curtailed innovation in the fields of pharmaceuticals and biotechnology. Specifically, the Federal Circuit’s shifting position on 35 U.S.C. § 112 and their evolving jurisprudence to combine expanding the application and scope of the written description requirement with a separate, heightened standard for enabling claims directed to innovation in a genus of therapeutic antibodies, or a genus of compounds having functional limitations, has caused havoc in the biopharmaceutical industry. Federal Circuit jurisprudence on how to interpret the disclosure requirements of the 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by mandating two separate disclosure requirements in place of one, namely that patent applications not only “enable” but also separately “describe” inventions. This recently developed and reactively evolving judge made approach raises the bar exceedingly high for obtaining any meaningful patent protection for new biomedical discoveries, goes against many decades of patent practice, and is proving to be a powerful impediment to the investment necessary for developing new and lifesaving medicines. This article examines patent law’s current disclosure requirements to highlight a failing judicial trajectory and proposes a return to a single 35 U.S.C. § 112(a) standard. By doing so, the great shock that has singled out and disrupted the biopharmaceutical industry will be removed and the law can once again encourage, in a technology-neutral manner, the private sector to innovate in all fields of endeavor, including encouraging the biopharmaceutical industry to develop new lifesaving medicines and treatments.
{"title":"A Singular Disclosure Requirement Is Necessary For Patent Law","authors":"S. Falati","doi":"10.52214/stlr.v24i2.11628","DOIUrl":"https://doi.org/10.52214/stlr.v24i2.11628","url":null,"abstract":"The Court of Appeals for the Federal Circuit’s recent jurisprudence on 35 U.S.C. § 112 has selectively and severely curtailed innovation in the fields of pharmaceuticals and biotechnology. Specifically, the Federal Circuit’s shifting position on 35 U.S.C. § 112 and their evolving jurisprudence to combine expanding the application and scope of the written description requirement with a separate, heightened standard for enabling claims directed to innovation in a genus of therapeutic antibodies, or a genus of compounds having functional limitations, has caused havoc in the biopharmaceutical industry. Federal Circuit jurisprudence on how to interpret the disclosure requirements of the 35 U.S.C. § 112 contravenes the statute and Supreme Court precedent by mandating two separate disclosure requirements in place of one, namely that patent applications not only “enable” but also separately “describe” inventions. This recently developed and reactively evolving judge made approach raises the bar exceedingly high for obtaining any meaningful patent protection for new biomedical discoveries, goes against many decades of patent practice, and is proving to be a powerful impediment to the investment necessary for developing new and lifesaving medicines. This article examines patent law’s current disclosure requirements to highlight a failing judicial trajectory and proposes a return to a single 35 U.S.C. § 112(a) standard. By doing so, the great shock that has singled out and disrupted the biopharmaceutical industry will be removed and the law can once again encourage, in a technology-neutral manner, the private sector to innovate in all fields of endeavor, including encouraging the biopharmaceutical industry to develop new lifesaving medicines and treatments.","PeriodicalId":87208,"journal":{"name":"The Columbia science and technology law review","volume":"37 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87822949","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}
Pub Date : 2023-01-02DOI: 10.52214/stlr.v24i1.10454
Brian Love, Christian Helmers
Despite the pervasiveness of patent licensing in many industries, there is a dearth of publicly available information on licensing transactions. Notably, information on price—i.e., the royalty agreed upon by licensor and licensee—is purposefully kept secret. We assess to what extent “market prices” on patent licenses are observable by assembling all publicly available information on royalty amounts associated with the licensing of 4G and 5G standard essential patents (SEPs). Our data come from a range of sources including court verdicts and litigation settlements, arbitration awards, public announcements, and published licensing agreements. We show that even for a highly visible technology such as mobile broadband, the available price points are few and far between. Moreover, any comparison of the available data points, let alone their aggregation, is extremely challenging due to largely unobservable heterogeneity in the terms and scope of the underlying licensing agreements. Our results point to a lack of transparency in the market for patent licensing that might adversely affect market participants and competition more broadly.
{"title":"Are Market Prices for Patent Licenses Observable?","authors":"Brian Love, Christian Helmers","doi":"10.52214/stlr.v24i1.10454","DOIUrl":"https://doi.org/10.52214/stlr.v24i1.10454","url":null,"abstract":"Despite the pervasiveness of patent licensing in many industries, there is a dearth of publicly available information on licensing transactions. Notably, information on price—i.e., the royalty agreed upon by licensor and licensee—is purposefully kept secret. We assess to what extent “market prices” on patent licenses are observable by assembling all publicly available information on royalty amounts associated with the licensing of 4G and 5G standard essential patents (SEPs). Our data come from a range of sources including court verdicts and litigation settlements, arbitration awards, public announcements, and published licensing agreements. We show that even for a highly visible technology such as mobile broadband, the available price points are few and far between. Moreover, any comparison of the available data points, let alone their aggregation, is extremely challenging due to largely unobservable heterogeneity in the terms and scope of the underlying licensing agreements. Our results point to a lack of transparency in the market for patent licensing that might adversely affect market participants and competition more broadly.","PeriodicalId":87208,"journal":{"name":"The Columbia science and technology law review","volume":"217 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135654175","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}
Pub Date : 2023-01-02DOI: 10.52214/stlr.v24i1.10455
Robin C. Feldman
Can something be both open and secret? That is the conundrum facing society as trade secret rights chafe against patent rights in cutting-edge, biologic medicine. The conflict is unsurprising. Trade secret has emerged as a relatively late bloomer among the family of intellectual property rights and only recently has begun to establish the boundaries of its own space, a process in which it will inevitably knock against other intellectual property doctrines already occupying their own domains. Nor is it surprising that the clash would arise in a fast-moving area of medical science. From insulin products, to cancer treatments, to mRNA vaccines, companies are staking the health of their companies on biologics. There is a dearth of legal literature on the topic of trade secrets in the biologic space and almost nothing regarding how trade secrets interact with the patent system in that domain. These scientific and legal areas are sufficiently complex that even the most intrepid scholars fear to tread. This article explains in detailed and accessible language how the systems are working together to the detriment of society. To address the problem, this article argues that a company receiving a patent on a drug product should be required to disclose the full range of trade secrets necessary to make that drug. As the descriptions below will explain, patent applicants are able to satisfy the patent requirement of providing sufficient disclosure that “one skilled in the art can make and use” the invention, without actually providing the information to do so. The surrounding regulatory systems intended to facilitate sharing of clinical trial data suffer the same problem. As is frequently said in biologics, “the process is the product.” In other words, the only way to define something derived from elements of living organisms is by describing the process of producing it. Thus, lack of process information is particularly problematic with biologics. Being faithful to the theoretical underpinnings of the intellectual property regimes requires a resolution of this problem and the establishment of a more effective boundary line between trade secrets and patents for biologic medicine.
{"title":"Trade Secrets in Biologic Medicine","authors":"Robin C. Feldman","doi":"10.52214/stlr.v24i1.10455","DOIUrl":"https://doi.org/10.52214/stlr.v24i1.10455","url":null,"abstract":"Can something be both open and secret? That is the conundrum facing society as trade secret rights chafe against patent rights in cutting-edge, biologic medicine. The conflict is unsurprising. Trade secret has emerged as a relatively late bloomer among the family of intellectual property rights and only recently has begun to establish the boundaries of its own space, a process in which it will inevitably knock against other intellectual property doctrines already occupying their own domains. Nor is it surprising that the clash would arise in a fast-moving area of medical science. From insulin products, to cancer treatments, to mRNA vaccines, companies are staking the health of their companies on biologics.\u0000There is a dearth of legal literature on the topic of trade secrets in the biologic space and almost nothing regarding how trade secrets interact with the patent system in that domain. These scientific and legal areas are sufficiently complex that even the most intrepid scholars fear to tread. This article explains in detailed and accessible language how the systems are working together to the detriment of society.\u0000To address the problem, this article argues that a company receiving a patent on a drug product should be required to disclose the full range of trade secrets necessary to make that drug. As the descriptions below will explain, patent applicants are able to satisfy the patent requirement of providing sufficient disclosure that “one skilled in the art can make and use” the invention, without actually providing the information to do so. The surrounding regulatory systems intended to facilitate sharing of clinical trial data suffer the same problem.\u0000As is frequently said in biologics, “the process is the product.” In other words, the only way to define something derived from elements of living organisms is by describing the process of producing it. Thus, lack of process information is particularly problematic with biologics. Being faithful to the theoretical underpinnings of the intellectual property regimes requires a resolution of this problem and the establishment of a more effective boundary line between trade secrets and patents for biologic medicine.","PeriodicalId":87208,"journal":{"name":"The Columbia science and technology law review","volume":"7 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87438458","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}
Pub Date : 2023-01-02DOI: 10.52214/stlr.v24i1.10453
E. Miller
The reports of antitrust’s death at the hands of decentralized blockchains were an exaggeration. The premise is logical: decentralized markets should mitigate the need for antitrust laws, which typically address abuses of power by, and secret collusion among, centralized firms in concentrated markets. Indeed, blockchains strive to prevent market structures that facilitate collusion and monopolization in the first place through decentralization, a form of antitrust self-regulation. And blockchain communities are debating and deciding how to effect this self-regulation, with the potential for autonomous implementations of market constraints designed to preserve decentralization, in real time and in public. All of this means that antitrust principles are very much alive on the blockchain. However, there exists a conflict: recent efforts to self-regulate antitrust may constitute per se violations of the very laws that such efforts are intended to preempt. The first to identify this conflict, this Article proposes that antitrust is entering a new blockchain era, one that is self-regulated and transparent, but not without risks. This Article then argues that self-regulation efforts in the blockchain context that would normally receive per se condemnation by U.S. courts, like price fixing, should instead receive more fulsome reviews under the rule of reason. The procompetitive potential of such self-regulation, combined with judicial inexperience in complex blockchain markets, warrants such an approach.
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Pub Date : 2023-01-02DOI: 10.52214/stlr.v24i1.10456
Geoffrey Xiao
Data scraping (also called web scraping, screen scraping, or web crawling) is a technique that uses “bots” to automate the collection of information from publicly available websites. Fundamentally, data scraping is data copying. Intellectual property (“IP”) law—namely, copyright—typically handles disputes involving copying. However, copyright law largely fails to protect data and databases (i.e., compilations of data). Instead, plaintiff websites assert contract law, Computer Fraud and Abuse Act (“CFAA”), and state unfair competition law (common law misappropriation, unjust enrichment, conversion, and trespass to chattel) claims against data scrapers. This Note proceeds as follows. First, this Note examines how scrapers can be liable under trade secret law for scraping data from publicly accessible websites. Initially, trade secret law seems incongruous with data scraping because the core concept of trade secret law—secrecy—is seemingly at odds with public accessibility. If a website is publicly available, how can a scraper be liable for trade secret misappropriation of the website’s data? This Note explains how a recent Eleventh Circuit case, Compulife Software Inc. v. Newman, laid the groundwork for a trade secret cause of action. This Note reconciles Compulife with existing trade secret jurisprudence, argues that Compulife was rightly decided as a matter of both law and policy, and provides a roadmap for courts to apply trade secret law to data scraping cases. Second, this Note explains why courts and litigators should use trade secret law to adjudicate data scraping disputes. Specifically, this Note argues that, compared to the existing alternatives, trade secret law is best suited to handle the various policy issues surrounding data scraping. This Note explains how contract law and the CFAA have filled the database void left by copyright law: contract law and the CFAA have become “quasi-IP” regimes, granting websites property rights in databases otherwise unprotected by copyright law. In response to the emergence of quasi-IP, this Note argues for reconceptualizing the data scraping problem by reframing data scraping as data copying—reframing data scraping with an intellectual property lens. Trade secret law offers a framework for that reconceptualization. In contrast to contract law and the CFAA (an anti-hacking law premised on criminal trespass principles), trade secret law provides courts and litigators with the appropriate IP-based doctrinal levers to analyze data scraping cases. Finally, this Note analyzes how EU law filled the database gap by creating an IP right, the sui generis database right. This Note argues that Compulife’s trade secret theory emulates many aspects of the EU sui generis database right. In this sense, Compulife’s trade secret theory can be seen as the United States’ attempt to fashion its own sui generis database right to fill the database gap left by copyright.
{"title":"Data Misappropriation","authors":"Geoffrey Xiao","doi":"10.52214/stlr.v24i1.10456","DOIUrl":"https://doi.org/10.52214/stlr.v24i1.10456","url":null,"abstract":"Data scraping (also called web scraping, screen scraping, or web crawling) is a technique that uses “bots” to automate the collection of information from publicly available websites. Fundamentally, data scraping is data copying. Intellectual property (“IP”) law—namely, copyright—typically handles disputes involving copying. However, copyright law largely fails to protect data and databases (i.e., compilations of data). Instead, plaintiff websites assert contract law, Computer Fraud and Abuse Act (“CFAA”), and state unfair competition law (common law misappropriation, unjust enrichment, conversion, and trespass to chattel) claims against data scrapers.\u0000This Note proceeds as follows. First, this Note examines how scrapers can be liable under trade secret law for scraping data from publicly accessible websites. Initially, trade secret law seems incongruous with data scraping because the core concept of trade secret law—secrecy—is seemingly at odds with public accessibility. If a website is publicly available, how can a scraper be liable for trade secret misappropriation of the website’s data? This Note explains how a recent Eleventh Circuit case, Compulife Software Inc. v. Newman, laid the groundwork for a trade secret cause of action. This Note reconciles Compulife with existing trade secret jurisprudence, argues that Compulife was rightly decided as a matter of both law and policy, and provides a roadmap for courts to apply trade secret law to data scraping cases.\u0000Second, this Note explains why courts and litigators should use trade secret law to adjudicate data scraping disputes. Specifically, this Note argues that, compared to the existing alternatives, trade secret law is best suited to handle the various policy issues surrounding data scraping. This Note explains how contract law and the CFAA have filled the database void left by copyright law: contract law and the CFAA have become “quasi-IP” regimes, granting websites property rights in databases otherwise unprotected by copyright law. In response to the emergence of quasi-IP, this Note argues for reconceptualizing the data scraping problem by reframing data scraping as data copying—reframing data scraping with an intellectual property lens. Trade secret law offers a framework for that reconceptualization. In contrast to contract law and the CFAA (an anti-hacking law premised on criminal trespass principles), trade secret law provides courts and litigators with the appropriate IP-based doctrinal levers to analyze data scraping cases.\u0000Finally, this Note analyzes how EU law filled the database gap by creating an IP right, the sui generis database right. This Note argues that Compulife’s trade secret theory emulates many aspects of the EU sui generis database right. In this sense, Compulife’s trade secret theory can be seen as the United States’ attempt to fashion its own sui generis database right to fill the database gap left by copyright.","PeriodicalId":87208,"journal":{"name":"The Columbia science and technology law review","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90105262","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}
Pub Date : 2022-03-07DOI: 10.52214/stlr.v23i1.9392
Jessica L. Hart
Blockchain networks have increasingly turned to proof-of-stake (“PoS”) protocols as a mechanism for discouraging bad behavior and securing participants’ data. In doing so, they have not only improved their energy consumption but also increased their accessibility. Still, the technological proficiency required of participants in PoS networks presents certain barriers to inclusivity. Third-party services known as staking-as-a-service (“StaaS”) providers have emerged as a popular solution to participants personally securing the network. The nature of this sub-contractual relationship has raised questions regarding the need for their regulation. In response to regulatory concerns, some practitioners have suggested that StaaS arrangements should qualify as “investment contracts” per SEC v. Howey and thus “securities” under the Securities Act of 1933. While much litigation has surrounded the question of whether cryptocurrencies vis-à-vis initial coin offerings (“ICOs”) constitute securities, none has yet addressed the question on StaaS providers within these networks. Accordingly, this Note explores the potential arguments in favor and against regulating StaaS providers as issuers of securities under Howey. It argues that the uniqueness of and variations among StaaS contracts make these arrangements unsuitable for regulation as securities. Instead, both StaaS users and PoS networks at large can benefit from a regulatory framework tailored to this innovative and nuanced technology.
区块链网络越来越多地转向权益证明(“PoS”)协议，作为阻止不良行为和保护参与者数据的机制。在这样做的过程中，他们不仅改善了能源消耗，而且增加了可及性。然而，PoS网络中参与者所要求的技术熟练程度对包容性存在一定的障碍。第三方服务即服务(“StaaS”)提供商已经成为参与者个人保护网络的流行解决方案。这种分包关系的性质提出了对其进行监管的必要性的问题。为了回应监管方面的担忧，一些从业者建议StaaS安排应该符合SEC v. Howey的“投资合同”，因此符合1933年证券法下的“证券”。虽然许多诉讼都围绕着加密货币与-à-vis首次代币发行(“ico”)是否构成证券的问题，但尚未解决这些网络中的StaaS提供商的问题。因此，本文探讨了支持和反对将StaaS提供商作为Howey下的证券发行人进行监管的潜在论据。它认为，StaaS合约的独特性和差异性使得这些安排不适合作为证券进行监管。相反，StaaS用户和整个PoS网络都可以从为这种创新和细致入微的技术量身定制的监管框架中受益。
{"title":"Policing Proof-of-Stake Networks","authors":"Jessica L. Hart","doi":"10.52214/stlr.v23i1.9392","DOIUrl":"https://doi.org/10.52214/stlr.v23i1.9392","url":null,"abstract":"Blockchain networks have increasingly turned to proof-of-stake (“PoS”) protocols as a mechanism for discouraging bad behavior and securing participants’ data. In doing so, they have not only improved their energy consumption but also increased their accessibility. Still, the technological proficiency required of participants in PoS networks presents certain barriers to inclusivity. Third-party services known as staking-as-a-service (“StaaS”) providers have emerged as a popular solution to participants personally securing the network. The nature of this sub-contractual relationship has raised questions regarding the need for their regulation. In response to regulatory concerns, some practitioners have suggested that StaaS arrangements should qualify as “investment contracts” per SEC v. Howey and thus “securities” under the Securities Act of 1933. While much litigation has surrounded the question of whether cryptocurrencies vis-à-vis initial coin offerings (“ICOs”) constitute securities, none has yet addressed the question on StaaS providers within these networks. Accordingly, this Note explores the potential arguments in favor and against regulating StaaS providers as issuers of securities under Howey. It argues that the uniqueness of and variations among StaaS contracts make these arrangements unsuitable for regulation as securities. Instead, both StaaS users and PoS networks at large can benefit from a regulatory framework tailored to this innovative and nuanced technology.","PeriodicalId":87208,"journal":{"name":"The Columbia science and technology law review","volume":"19 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84794231","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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