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Abstract:
The view that biotechnology patenting has reached unsustainable levels is well accepted among many legal scholars. This Article presents the first comprehensive empirical study of biotechnology patents. Our analysis reveals the striking rise and fall in patenting, the surprisingly diffuse pattern of patent ownership, and a consistent influx of new entrants conducting biotechnology research and development. This Article finds little evidence that the rise in biotechnology patenting is adversely affecting innovation. Counting patents, as it turns out, offers few insights on its own. One must also have a measure of the geographic scope of the scientific commons and the distribution of patents within it. These findings lead to a cautionary corollary for patent metrics generally - fundamental uncertainties associated with the statistics of innovative success cannot be overcome by sophisticated empirical methods. Ironically, the current enthusiasm for empirical work may have caused academics to reify abstract statistics over the obvious complexity of innovative processes.

biotechnology, patents, statistics, metrics

Abstract:
A hallmark of environmental federalism is that neither the states nor the federal government limits themselves to what many legal scholars have deemed to be their appropriate domains. The federal government regulates local issues, such as remediation of contaminated industrial sites, while states and local governments develop policies on environmental issues of national or even international scale, such as global climate change. The current system of environmental federalism is thus a dynamic one of overlapping federal and state jurisdiction. It is increasingly threatened, however, by federal legislation and Supreme Court rulings that favor preemptive federal control. This Article advocates an adaptive model of environmental federalism that reinforces the existing dynamic system. Our approach rejects the dominant economic theory, which holds that regulatory authority should reside at the level of government that roughly "matches" the geographic scope of the subject environmental problem. We show that its one-sided focus on static optimization is ill-suited to the complexity and variability of environmental problems. Drawing on an emerging trend in legal scholarship that calls for a dynamic conception of federalism, our adaptive model recognizes the importance of sustaining both a diversity of regulatory options and the processes for winnowing and refining them. An adaptive framework would exploit local variability, as well as the unpredictability of nature itself, to make the federal system both highly adaptable and resilient to environmental change. We propose several doctrinal and legislative principles to enhance the dynamic attributes of environmental federalism. These prescriptions include adopting a judicial presumption, and a corresponding principle of legislative drafting, against federal preemption, as well as a more specific presumption against federal regulations that preclude states from establishing more stringent standards. We further advocate tempering uniform federal standards by allowing a small number of competing state standards.

environmental federalism, federalism, adaptive federalism, dynamic federalism, cooperative federalism, environmental law, preemption, matching principle, Revesz, Stewart, Esty, Farber, Schapiro, scale, climate change, complexity theory

Abstract:
Much like tort reform, the debate over pending legislation on biotech drugs - and particularly regulatory supplements to patent protection - has taken on a significance that dwarfs its impact on overall health care expenditures. Under the pending Health Care Reform legislation, Congress would enact two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics, which are the analogues of generics for conventional drugs. Second, establishment of a twelve-year “data exclusivity” period during which clinical testing data collected by brand-name producers could not be used by competitors to satisfy FDA testing requirements. While the abbreviated FDA approval process enjoys broad support, the data-exclusivity provision has been hotly contested, including strong opposition from the Federal Trade Commission.

We argue that regulatory data exclusivity is a sideshow. Current estimates find that the effect of data exclusivity on health care expenditures would be trivial. For this and other reasons, any potential benefit to patients that might result from a shorter period of data exclusivity would be outweighed by the financial risks to the biotech industry, and particularly the negative impacts on investments in research and development. More importantly, we believe that the current focus on data exclusivity is misplaced. Weak competition in markets for biotech drugs poses a much greater and longer-term problem for patient access - without effective competition, pricing of many biotech drugs will remain high indefinitely. The most important issue for Congress to address ought to be minimizing the barriers to market entry for manufacturers of follow-on biologics after the relevant patent terms and data exclusivity end. We close the article by suggesting a variety of ways in which this objective could be met.

Biotechnology, Biologics, Patents, FDA, Health Care Reform

Abstract:
Virtually anyone with an interest in environmental policy is familiar with the allegations that traditional methods of statistical inference are biased against preventative environmental standards. They surely also know of the Precautionary Principle as the broad theory often cited by environmentalists to support this critique and to argue that regulated industries should bear the burden of proving that their products and activities are safe. This collision between scientific method and environmental principle has had great salience in environmental law and policy for many years. However, the debate loses much of its force and momentum because it is premised on a relatively superficial understanding of the underlying statistical methods. This Article seeks to move beyond the heuristics of the current discourse.

The Article examines the role of statistical methods in environmental policy-making and describes the interplay between scientific assessments and frequentist statistics. Part I provides a brief introduction to frequentist methods. Part II addresses the debate over burdens of proof and minimizing statistical error rates in environmental law, and uses several rationales for the Precautionary Principle to evaluate common misconceptions about the use of frequentist methods in environmental science. This Article demonstrates that statistical tests are more flexible than most people appreciate and proposes a solution to environmentalists' concerns, "equivalence testing," that reverses the benign-until-proven-guilty presumption of traditional frequentist methods. It concludes by identifying the respective limits of statistical inference and the Precautionary Principle in environmental decisionmaking.

Environmental law, precautionary principle, statistics, risk, scientific uncertainty

Abstract:
The image of science that has emerged from debates over environmental policy is distorted by expectations that are simultaneously too great and too modest. By clinging to a classical vision of science, critics set environmental science up for failure; by presuming that scientific results are primarily the product of ideology, they risk trivializing their value. This Article looks beyond the domain of environmental law to identify appropriate benchmarks for the role of science in environmental policymaking. A unique contribution of the Article is identification of finance theory and modeling as an exemplar for effective application of sophisticated scientific methods.

law and science, environmental science, statistics, scientific uncertainty, risk

Abstract:
This Article challenges the prevailing view that state action on climate change is misconceived because it cannot meaningfully impact greenhouse gas emissions. We argue that inducing technological change provides an independent ground for state programs; one can think globally and still act locally. Technological innovation is essential to successful climate policy and subject to a distinct market failure - technology spillovers that undermine investment incentives. State action can significantly enhance technological change, as promoting innovation is less dependent on large-scale government action and its inherent uncertainties favor the diversity sustained by multiple state programs. These observations suggest a two-tiered strategy: primary federal responsibility for reducing greenhouse gas emissions while state policies focus on promoting technological change. The Article concludes by proposing measures designed to support this complementary federal-state framework.

Climate Change, Federalism, Innovation Policy, Inducing Technological Change