Authorized Generics: A Prescription for Hatch-Waxman Reform

Authorized generics present the latest controversy in the perennial battle between pioneer and generic drug manufacturers. Under these arrangements, a pioneer firm will “authorize” a generic version of its brand-name drug to enter the market during another generic competitor’s 180-day exclusivity period. This practice has generated intense debate within the pharmaceutical industry regarding its potential impact on Paragraph IV patent challenges, in addition to the proper operation and intent of the Hatch-Waxman Act. Because of the immense economic and public health consequences at stake, and previous patterns of Hatch-Waxman abuse, the Federal Trade Commission has recently launched an investigation of authorized generics.

This Note explores the qualitative nature of pharmaceutical competition, specifically focusing on the interaction between pharmaceutical supply chain economics and consumer behavior. From these observations, I propose a theory of competitive harm and conclude that authorized generics are an anticompetitive strategic behavior which violate the antitrust laws by deterring Paragraph IV entry. I find normative support within the Hatch-Waxman and patent law regimes to corroborate my antitrust analysis. Finally, I recommend potential solutions to the authorized generics controversy, including Hatch-Waxman legislative reform.

Mens Rea and the Cost of Ignorance

This Essay advances a new understanding of the controversial doctrine of strict criminal liability. While the conventional view holds that strict criminal liability aims at alleviating the administrative burden of proving defendants’ mental state, this Essay argues that this doctrine also can induce genuinely ignorant offenders to acquire information. The predominant mens rea standard assures ignorant offenders that they can engage in the prohibited conduct without being penalized. This drawback, however, is mitigated when offenders find that the market imposes too high a cost on ignorance. If ignorance is sufficiently costly, offenders will take steps to become (or remain) informed notwithstanding the adverse incentive created by the mens rea standard. The Essay thus predicts that, other things being equal, strict liability is likely to be especially useful in those elements of a criminal offense for which ignorance is virtually costless. The Essay demonstrates the illuminating power of this explanation by analyzing the application of strict liability to liquor sale to minors, statutory rape, child pornography, regulatory offenses, criminal liability of corporate officers, and mistakes of law and fact. The Essay concludes by exploring whether alternative doctrines may induce offenders to acquire information without producing the harsh and unfair consequences often attributed to strict liability.

The Temporal Dimension of Voting Rights

Modern voting rights scholarship agrees on one thing: voting rights are in large part aggregate rights. Accordingly, one cannot evaluate voting rights claims, or the fairness of the electoral system, without establishing the boundaries of appropriate aggregation. This framework has led the literature to focus on spatial aggregation. That is, commentators concentrate on when it is appropriate to aggregate across persons located in different places to determine the fairness (or constitutionality) of a voting rule. Almost entirely overlooked, however, is the possibility of temporal aggregation. To evaluate the fairness of a voting rule, one must also pick a time period across which to aggregate the collective treatment of individual voters. This Article explores the temporal dimension of voting rights, showing that temporal aggregation issues play a central but unexamined role in many voting rights disputes, including the partisan gerrymandering cases recently decided by the Supreme Court. In addition, the Article highlights the importance of temporal aggregation for a number of concrete disputes in voting rights theory and doctrine. Understanding the temporal dimension of voting rights expands the available strategies for incorporating minority voices into legislative assemblies, provides a new perspective on the debates over partisan gerrymandering, and helps reconcile disagreements over the appropriate role of competition in the electoral process.