Volume 87, Issue 3
Articles
In this Article, Professor Benjamin N. Roin exposes a significant flaw in the current patent system that, he argues, presents a significant impediment to pharmaceutical innovation: socially valuable drugs often cannot be patented and are therefore unlikely to be developed for public use. This flaw, according to Roin, is the result of two fundamental requirements for patent protection—novelty and nonobviousness—coupled with the massive R&D costs necessary to develop a new drug in a way that satisfies the FDA's safety and efficacy standards.
Professor Roin begins with a discussion of the necessity of the patent system for innovation in the drug industry: since unpatented drugs are vulnerable to free-riding by generic manufacturers, pharmaceutical companies would usually find it impossible to recoup their R&D investments without the delay in generic competition that a patent provides. This fact underscores the significance of Roin's assertion that the novelty and nonobviousness requirements render many potentially useful drugs unpatentable. After providing a detailed account of the various ways in which these two requirements serve to prevent the patentability of many new drugs, Professor Roin offers practical evidence that the patent standards routinely deter private industry from developing promising drug candidates. Therefore, Roin argues, the current patent system is preventing the development of untold numbers of beneficial drugs, which results in considerable harm to the public. After considering the relative costs and benefits of two other possible solutions to this dilemma—patent reform and direct government funding of clinical trials—Professor Roin concludes that the best way for Congress to promote the development of unpatentable drugs is through the FDA, by requiring the agency to withhold regulatory approval from generics for long enough to replicate the protection normally provided by patents.
Responses in See Also:
Are repeat offenders more culpable than first-time offenders? In the United States, the most important determinant of punishment for a crime, other than the seriousness of the crime itself, is criminal history. In this Article, Professor Youngjae Lee presents an original and provocative argument in defense of the recidivist premium—the practice of punishing repeat offenders more harshly than first-time offenders—within the context of retributivism and the notion of just deserts.
While theories of deterrence, incapacitation, and rehabilitation may provide plausible defenses of the recidivist premium, the practice has traditionally been problematic for retributivists, who assert that criminals deserve to be punished only to a degree that is proportional to the seriousness of the crime committed. Professor Lee examines three arguments that attempt to explain why recidivist criminals deserve enhanced punishment—arguments based on character, notice, and defiance—and exposes significant flaws in each. He argues that the recidivist premium should be thought of as punishment not for a defiant attitude or a bad character trait, but as punishment for an omission. The culpable omission that justifies the recidivist premium is the repeat offender's failure, after conviction, to arrange his life in a way that ensures a life free of further criminality. Professor Lee recognizes that how one conducts one's life as a general matter is not properly the business of the state, but asserts that once one is convicted of a crime, one enters into a thick relationship with the state and that relationship gives rise to an obligation for the offender to rearrange his life in order to steer clear of criminal wrongdoing. For Professor Lee, this relational account can serve both as an affirmative basis for increasing a repeat offender's punishment and as a negative constraint that limits permissible amounts of punishment. Finally, he argues that the relationship between the offender and the state is a two-way street, in the sense that the obligations of offenders are met with the state's corollary obligation not to interfere with their return to normal life.
Book Reviews
In her review of their book Bending Science, Professor Lisa Heinzerling praises Thomas O. McGarity and Wendy E. Wagner for producing an "immensely important book" that is both frightening and constructive. It is frightening because it provides a detailed account of the various ways in which the scientific process can be, and has repeatedly been, bent to produce a result consistent with economic or ideological motives. When scientific research in the areas of public health and the environment is bent in the ways described by McGarity and Wagner, the impact is often dangerous and lives can be lost. The book is constructive, according to Heinzerling, for several reasons.
First, McGarity and Wagner provide a useful taxonomy of the ways in which science can be bent—by shaping science, hiding science, attacking science, harassing scientists, packaging science, and spinning science—which aids the public in identifying the practice of science bending when it occurs. Second, by documenting examples of bent science within the context of this taxonomy—documentation which Heinzerling praises as being decidedly evenhanded—McGarity and Wagner make clear how pervasive the practice of bending science is and how early in the scientific process it can begin. Finally, McGarity and Wagner bring the useful perspective of lawyers to the problem of bent science. They illuminate the ways in which the law now promotes, or at least does not discourage, scientific distortions, and they offer numerous suggestions for legal reform.
Notwithstanding her praise of the work of McGarity and Wagner, Professor Heinzerling suggests that they may not go far enough in their condemnation of the practice of bending science, and asserts that there is an element of violence at the heart of bent science which may implicate criminal laws against murder. She argues that characterizing bent science in the realm of public health as violence, and perhaps even murder, reveals the practice for what it is: "a circuitous but sure way to watch people fall ill and die."
Notes
In his new book Weak Courts, Strong Rights, Professor Mark Tushnet considers the most effective form of judicial review in the context of protecting socioeconomic rights. He embarks on this analysis by identifying two types of judicial review—"strong-form" and "weak-form"— and examining them using a comparative analytical framework, looking to rights-enforcement models from around the world. Tushnet concludes that weak-form review is most consistent with a commitment to democratic self-governance, and is thus the most desirable mode of review. After analyzing several examples of weak-form review in practice, Tushnet argues that a form of the "dialogic" mode of review—in which a legislature "sometimes, and not rarely," but not "too often, or routinely," asserts its own understanding of the constitution above that of the judiciary—is the ideal system for the protection of socioeconomic rights. In his review of Professor Tushnet's new book, Brett Kaufman evaluates Tushnet's framework under both a theoretical and a practical approach.
Kaufman employs public choice analysis—which he argues is applicable to constitutional decision making—to conclude that Tushnet's weak-form system, which leaves the "legislature's insistence on its own reasonable interpretation legally effective," provides inadequate protection of socioeconomic rights. On a practical level, Kaufman examines constitutional decision making in Latin America. Through case studies of several Latin American courts, Kaufman demonstrates that the protection of constitutional social and economic rights in that region would not be viable without a strong judiciary having the authority to be the last mover in the constitutional dialogue. Thus, Kaufman argues, a stronger version of Tushnet's dialogic mode of review—the "weak–strong" approach to the enforcement of socioeconomic rights—ultimately holds the greatest promise for the protection of these rights around the world.
In this Note, Christopher M. Weimer examines the current state of foreign direct investment (FDI) review as it relates to national security. As a backdrop for his analysis, Weimer presents statistical data to demonstrate the importance of FDI to the U.S. economy, and provides examples of the types of threats that foreign investment can pose to national security.
He then analyzes the current regulatory framework—a framework that has developed through a combination of Congress's apprehension regarding particular transactions and its frustration with Executive inaction—as it currently exists after the passage of the Foreign Investment and National Security Act (FINSA) in 2007. After identifying several significant shortcomings, Weimer concludes that the current regime, in which the Committee on Foreign Investment in the United States (CFIUS) is charged with reviewing foreign-investment transactions for potential security threats, does not adequately serve the interests of either the domestic economy or national security. As an alternative to current the regulatory scheme, Weimer proposes the use of a modified form of the golden shares currently used in the United Kingdom to ensure protection in a limited number of security-sensitive firms. The use of golden shares, Weimer argues, could offer increased certainty in national-security protections while limiting the threat of government interference in foreign investment in the majority of sectors, thus encouraging the inflow of much-needed foreign capital. Finally, Weimer seeks to demonstrate the superiority of this approach through the hypothetical application of the golden shares concept to two recent FDI controversies: Magnequench and the rise of sovereign-wealth funds.
