Current Issue: Volume 20

Masthead: Volume 20

Sam F. Halabi
20 Yale J. L. & Tech. 1

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.

Al-Amyn Sumar
20 Yale J. L. & Tech. 74

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.