Science and Technology Law Review

The Price Tag of "Pay-for-Delay"

2022-03-06T23:39:32+00:00

In a landmark decision nearly a decade ago, the U.S. Supreme Court opened the door for antitrust suits against brand and generic pharmaceutical companies who engage in collusive settlements to delay the time for the generic to come to market. With these “pay-for-delay” agreements, brand-name companies offer prospective generics some form of compensation in exchange for the generic’s promise not to enter the market until an agreed-upon date. Laying the groundwork for the lawsuit that would eventually lead to the Actavis decision, the Federal Trade Commission (“FTC”) published a study estimating that pay-for-delay agreements cost American consumers $3.5 billion annually, a figure that has been cited repeatedly by scholars and policymakers alike.

To understand the state of pay-for-delay agreements, this Article presents an in-depth examination of the burden that pay-for-delay imposes, both on society at large and on individual patients, and explores the modern legal landscape that has emerged since the Supreme Court’s historic pronouncement. Part I describes pay- for-delay agreements, exploring the literature on the potential harm of such agreements among pharmaceutical competitors. Part II presents a new analysis demonstrating that the cost of pay-for-delay to American consumers is far greater than anyone has recognized, and well beyond the $3.5 billion figure cited by the FTC in 2010. We applied six different methodologies to provide as fair and broad a view as possible. The range of methodologies show that at a minimum, the cost of pay-for-delay settlements on the U.S. population between 2006 and 2017 is $6.2 billion per year—almost double that of the FTC’s estimate. The methodology with the largest result suggests that the cost could be as high as $37.1 billion per year— ten times higher. Part III argues that courts are allowing this costly problem to flourish unchecked. This part reviews pay-for-delay decisions since Actavis, arguing that the courts have failed to properly analyze such cases from the perspective of all three notions inherent in the words “pay,” “for,” and “delay.” Finally, Part IV offers a path forward through the doctrinal haze.

Privacy as the Price of Drug Access

2022-03-06T23:48:01+00:00

In response to the recent increase in FDA-approved specialty drugs and escalating specialty drug prices, drug companies now offer patient support programs (“PSPs”) for eligible patients prescribed a particular pharmaceutical drug. Such programs encompass both financial assistance for the purchase of a specialty drug and behavioral services, including nursing support and injection training, intended to improve drug adherence. Although ostensibly gratuitous, these programs have a steep and underappreciated cost: disclosure of protected health information. In effect, patient support programs compel patients to trade protected health information for drug access. This Article provides the first in- depth examination of the legal and ethical concerns associated with patient support programs. Enrollment in a drug company’s patient support program furnishes the company with linked patient- and prescriber- identifying information for each enrollee, data which may enable drug companies to target marketing to patients and healthcare providers with an otherwise unattainable degree of precision. Moreover, once a drug company acquires an enrollee’s protected health information pursuant to a valid Health Insurance Portability and Accountability Act (HIPAA) authorization, a drug company faces few limits on downstream uses of those data. This Article illuminates a possible role for patient support program-mediated data collection in two unlawful drug company practices: (1) kickback schemes in coordination with foundations that cover pharmaceutical drug copays, and (2) “product hopping” to a new brand-name drug formulation after patent expiration of an older formulation. The current regime for health data privacy in the United States lacks adequate safeguards to prevent drug companies from exploiting patient support program-derived data to the detriment of patients. The Article ends by proposing practical modifications to the HIPAA Privacy Rule to modernize HIPAA’s protections vis-à-vis health data transferred from covered entities to noncovered entities such as drug companies.

Intelligent Legal Tech to Empower Self-Represented Litigants

2022-03-06T23:53:20+00:00

Legal technologies, or “legal tech,” are disrupting the practice of law and providing efficiencies for businesses around the globe. Indeed, legal tech often conjures up notions of billion-dollar businesses and highly sophisticated parties. However, one branch of legal tech that holds particular promise for less sophisticated parties is access to justice (“A2J”) through the use of online dispute resolution (“ODR”). This is because ODR uses technology to enable online claim diagnosis, negotiation, and mediation without the time, money, and stress of traditional court processes. Indeed, courts are now moving traffic ticket, landlord-tenant, personal injury, debt collection, and even divorce claims online. The hope is that legal tech such as online triage and dispute resolution systems will provide means for obtaining remedies for self- represented litigants (“SRLs”) and those who cannot otherwise afford traditional litigation. Meanwhile, the COVID-19 pandemic has accelerated the growth of online processes, including court and administrative processes that traditionally occurred in person. Nonetheless, these online processes seem focused mainly on case management and communication, neglecting the need for more imaginative and innovative uses of technology. Accordingly, this Article proposes a six-module system for ODR programs and identifies gaps in development where new technologies are needed to advance A2J. Indeed, there is great room for the development of Artificial Intelligence (“AI”) and data analytics to assist SRLs and others in pursuit of remedies and justice.

Policing Proof-of-Stake Networks

2022-03-06T23:59:00+00:00

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.