The Drug Repurposing Ecosystem: Intellectual Property Incentives, Market Exclusivity, and the Future of “New” Medicines
The pharmaceutical industry is in a state of fundamental transition. New drug approvals have slowed, patents on blockbuster drugs are expiring, and costs associated with developing new drugs are escalating and yielding fewer viable drug candidates. As a result, pharmaceutical firms have turned to a number of alternative strategies for growth. One of these strategies is “drug repurposing”—finding new ways to deploy approved drugs or abandoned clinical candidates in new disease areas. Despite the efficiency advantages of repurposing drugs, there is broad agreement that there is insufficient repurposing activity because of numerous intellectual property protection and market failures. This Article examines the system that surrounds drug repurposing, including serendipitous discovery, the application of “big data” methods to prioritize promising repurposing candidates, the unorthodoxly regulated off-label prescription practices of providers, and related prohibitions on pharmaceutical firms’ off-label marketing. The Article argues that there is a complex ecosystem in place and that additional or disruptive IP or market exclusivity incentives may harm as much as help in promoting repurposing activity. To illustrate this threat, the Article traces the trajectory of metformin, a common diabetes drug that shows promise for conditions ranging from polycystic ovary syndrome to breast cancer. From the initial reasons for Bristol-Myers Squibb to refuse to invest in promising alternative uses, to the institutions, researchers, and regulators who identified possibilities for metformin treatment, this Article aims to map the role of intellectual property protection, market exclusivity, and search for capital that led to metformin’s ascent as a repurposed drug. The Article contributes a concrete understanding to an important problem in pharmaceutical law and policy, one for which scholars have quickly suggested more powerful patent and market exclusivity protection when doing so may undermine the very processes now leading to effective alternative uses for existing drugs.
Prior Restraints and Digital Surveillance: The Constitutionality of Gag Orders Issued Under the Stored Communications Act
The First Amendment’s prohibition on prior restraints on speech is generally understood to be near-absolute. The doctrine permits prior restraints in only a handful of circumstances, and tends to require compelling evidence of their necessity. The focus of this Article is the source of an unexpected but important challenge to this doctrine: government surveillance in the digital age. Recent litigation about the constitutionality of the Stored Communications Act (SCA) highlights that challenge. The SCA authorizes the government both to obtain a person’s stored internet communications from a service provider and to seek a gag order preventing the provider from even notifying the person of that fact. Though the government did not ultimately prevail in the litigation, the case provides a renewed opportunity to consider the tension between prior restraint doctrine and the government’s digital surveillance efforts.
As artificial intelligence and big data analytics increasingly replace human decision making, questions about algorithmic ethics become more pressing. Many are concerned that an algorithmic society is too opaque to be accountable for its behavior. We set out to test the limits of transparency around governmental deployment of big data analytics, contributing to the literature on algorithmic accountability with a thorough study of the opacity of governmental predictive algorithms. Using open records processes, we focused our investigation on local and state government deployment of predictive algorithms.
This Article explores the implications for medical care of a debate that is more familiar in the law and ethics of human subjects research: whether people should be paid to receive or decline medical interventions, or to reach certain health objectives. It examines the legal and ethical issues such payments raise, and considers various actors who might make such payments, including governments, employers, insurers, care providers, and private parties. It argues for two interrelated conclusions: first, that these payments should not be subject to blanket normative condemnation, and, second, that payments made in different settings and contexts frequently share underlying commonalities, which suggests categorizing them according to these commonalities. We should move from a “siloed” legal and normative landscape, where discussions of payments to patients in one context are isolated from similar discussions in other contexts, to a landscape where payments are evaluated and categorized more systematically. The categories along which payments should be evaluated include who the payer is, what purpose the payment serves, and who the payment affects.
This article analyzes the long-term impact of the Second Circuit’s opinion in Lola v. Skadden, Arps, Slate, Meagher & Flom LLP, 620 F. App’x 37 (2d Cir. 2015), on the legal field’s existing monopoly over the “practice of law.” In Lola, the Second Circuit underscored that “tasks that could otherwise be performed entirely by a machine” could not be said to fall under the “practice of law.” By distinguishing between mechanistic tasks and legal tasks, the Second Circuit repudiated the legal field’s oft-cited appeals to tradition insisting that tasks fall under the “practice of law” because they have always fallen under the practice of law. The article proceeds by first discussing the procedural history and decision in Lola v. Skadden. It then explains the technological advances that will impact the legal field and the tools used by the legal field to perpetuate its self-regulating monopoly. The article then turns to the socioeconomic implications of technological disruption within the legal field and concludes with a discussion on how lawyers may prepare themselves for, and thrive within, an inevitably automated future.
Ten years ago, the city of Chattanooga, Tennessee built its own high-speed Internet network, and today Chattanooga’s publicly owned Internet infrastructure (“public broadband” or “municipal broadband”) is faster and more affordable than almost anywhere else in the world. In this Article, I make the case for why other communities currently underserved by private broadband providers should consider building their own high-speed broadband networks and treating Internet as an essential public service akin to water or electricity, and I explore means by which these communities can overcome the legal and political hurdles they may face along the way.
State-sponsored cyber-attacks are on the rise and show no signs of abating. Despite the threats posed by these attacks, the states responsible frequently escape with impunity because of the difficulty in attributing cyber-attacks to their source. As a result, current scholarship has focused almost exclusively on overcoming the technological barriers to attribution. This Note suggests that a legal approach, rather than a technological one, can solve the attribution problem. First, despite the barriers to attribution, computer scientists have developed a range of tools to trace cyber-attacks, and empirically, large-scale state attacks tend to leave behind enough footprints (or circumstantial evidence) to lead forensic experts to their source. Second, the law does not demand guaranteed certainty, but only a sufficient degree of certainty that someone is responsible; the question of what counts as a sufficient degree of certainty is an answerable, purely legal question. Thus, the question is no longer whether cyber-attacks can be attributed; instead, it is how the international community might configure a system of law to do so. By surveying the scope of existing procedural rules—including the features of adversarial and inquisitorial systems, burdens of proof and persuasion, state responsibility doctrines, and rules governing evidentiary production—this Note explains how a system of law can be created to address the seemingly unique problem of identifying the source of cyber-attacks. In doing so, this Note lays the groundwork for envisioning an international tribunal and procedure for states to address the threats posed by state-sponsored cyber-attacks.