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Item What Will It Take to Reap the Clinical Benefits of Pharmacogenomics?(Food & Drug Law Journal, 2006) Evans, Barbara J.Genetically targeted drug and biologic therapies promise a new era of personalized medicine, but there has been frustration with how slowly these therapies are moving from concept to actual clinical application. Various legal and regulatory barriers threaten to delay translation of basic discoveries into approved products and to slow the clinical uptake of new therapeutic products as they become available. There is a pressing need to reach consensus on what these barriers are, so that they can be addressed in a timely and effective manner. This paper explores what some of the key barriers may be. It examines: (1) legal, regulatory, and commercial barriers to “successive improvement” of existing drugs through improved targeting strategies; (2) barriers to cooperative, multi-party development of targeted therapies; (3) methodological problems in assessing the incremental health and economic benefits of an improved targeting strategy; (4) limitations of traditional product labeling as a medium for communicating timely, clear information about drug targeting to clinicians and the need to create new mechanisms within the medical profession to manage and communicate this information; and (5) difficulty defining the appropriate line between regulation of medical products and regulation of medical practice, in the case of targeted therapies.Item The Unfinished Business of US Drug Safety Regulation(Food & Drug Law Journal, 2006) Evans, Barbara J.; Flockhart, David A.Various proposals have been advanced in response to recent problems with the safety of Food and Drug Administration (FDA)-approved drugs. Many call for incremental change, such as new safety oversight bodies or minor expansions of FDA's existing powers. "Fixing" FDA may not fix the problem, without related reform of the broader legal framework in which FDA operates. Key reform challenges include promoting clinical compliance with important safety warnings while preserving needed flexibility for physicians to adapt drug use to the individual patient; developing a clearer distinction between pre- and postapproval safety regulation; and devising mechanisms for funding investments in safety improvements. Until these fundamental problems are addressed, the United States will face ongoing problems with drug safety and patients will be denied the full measure of safety and therapeutic benefit that today's technologies could support. This article proposes a new direction to address these problems in the context of an insurance-based framework for promoting drug safety.Item Altered standards of care for health care providers in the pandemic influenza(Indiana University, 2009) Kinney, Eleanor D.; McCabe, Heather A.; Gilbert, Amy Lewis; Shisler, Janna JoPandemic influenza will pose tremendous challenges to health care providers, state public health authorities, and the public. All will have to conduct business under the most adverse of circumstances. It will be difficult for providers to meet the customary legal standards of care imposed by state and federal regulatory authorities, as well as the common law tort system. This white paper will explore the legal issues associated with altered standards of care in pandemic influenza.Item The Draft Common Frame Of Reference (DCFR) - the Most Interesting Development in Contract Law Since the Code Civil and the BGB(2012) Emmert, FrankThe paper presents the DCFR, which is the blueprint for the future Code of Obligations of the European Union and works or works a bit like the UCC in the United States, that is, as a model of commercial code. After a brief historical justification of the project, there is a presentation of what may or may not make the DCFR today. Finally, the potential effect of the MCR project to be chosen by the parties to an international sale transaction is explained through a hypothetical situation.Item Illuminating Innovation: From Patent Racing to Patent War(Washington & Lee Law Review, 2012) Shaver, LeaPatent law assumes that stronger protection promotes innovation, yet empirical evidence to test this “innovation hypothesis” is lacking. This Article argues that historical case studies hold unique promise to provide an empirical foundation for modern patent policy. Specifically, this Article uses the history of patents surrounding the light bulb to examine a recently articulated theory of “patent racing” as a justification for patent protection. Thomas Edison’s experience confirms that Mark Lemley’s racing model has substantial descriptive merit. Yet this case study also reveals the limits of the patent racing model. Looking past the initial finish line of patent filings to later litigation, the competition looks less like a race and more like a war. The Article then proposes a new model of “patent warfare” resembling the board game Risk. In the game, competing parties assemble strategic assets, then turn to battle their rivals for world domination. Similarly, innovative technology companies assemble patent portfolios—initially for defensive purposes in the context of a dynamic and competitive field. As an industry matures, however, dominant players convert their shields into weapons to eliminate their competition. Just as nineteenth-century companies in the early electrical industry battled to control the light bulb, a new patent war is now emerging to control the smartphone. This anticompetitive endgame diminished next-generation innovation in electric light and now threatens the future of innovation in mobile computing. A new appreciation of patent warfare should prompt increased skepticism of the “innovation assumption” at the heart of patent law. Patent protection clearly provides short-term benefits to innovation, but it also produces unanticipated longterm costs to competition and next-generation innovation. Further empirical research is needed to ascertain whether the benefits outweigh the costs or vice versa and what tweaks to the patent system might allow us to continue to capture the benefits while lowering the costs. In this continued effort, historical case studies will prove particularly helpful because they permit insight into the complex workings of patent law on an industry over a longer time horizon, revealing not only the short-term benefits but also the long-term costs.Item Defining and Measuring A2K: A Blueprint for an Index of Access to Knowledge(I/S: A Journal of Law and Policy for the Information Society, 2008) Shaver, LeaAccess to knowledge (A2K) is increasingly recognized as the central human development issue of our time. Yet to date there has been little literature defining precisely what is meant by this term, much less how to evaluate the progress toward achieving it. To help bridge this gap, this article offers a blueprint for an A2K index: a quantitative tool integrating a variety of data points to assess how well countries promote access to knowledge. The proposed index tracks five key dimensions of access to knowledge: education for informational literacy, access to the global knowledge commons, access to knowledge goods, an enabling legal framework, and effective innovation systems. The resulting conceptual map offers a concrete introduction to the A2K framework for information scholars and professionals.Item The Right to Science and Culture(Wisconsin Law Review, 2010) Shaver, LeaThe Universal Declaration of Human Rights states: “Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits.” This Article suggests how this text may offer a philosophical and legal basis to constrain the further expansion of protectionism in international IP law. Drawing on accepted methodologies of human rights interpretation and recent research from legal and economic scholars on the value of preserving the knowledge commons, the Article offers a theory of “the right to science and culture” as requiring a public goods approach to knowledge innovation and diffusion. The Article then translates this public goods theory into concrete guidance for policy makers seeking to implement human rights obligations, and for jurists asked to adjudicate rights-based challenges to copyright and patent laws. In conclusion, this Article suggests that reviving attention to this long-marginalized provision of international public law may provide an important rhetorical and legal tool with which to open up new possibilities for sensible IP reform.Item The Inter-American Human Rights System: An Effective Institution for Regional Rights Protection?(Washington University Global Studies Law Review, 2010) Shaver, LeaThe Inter-American Court of Human Rights and the Inter-American Commission on Human Rights are charged with protecting human rights in the Western Hemisphere. This article explains the workings of this regional human rights system, examining its history, composition, Junctions, jurisdiction, procedure, jurisprudence, and enforcement. The article also evaluates the system's historical and current effectiveness. Particular attention is given to the disconnect between the system's success with the region's Latin-American nations and its rejection by Anglo-American States, as well as to the potential to use the system to improve human rights in Cuba.