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Full-Text Articles in Health Law and Policy

Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman Jan 2020

Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman

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Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …


Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro Oct 2014

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

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The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.

As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to …


Preface To Fatal Invention: How Science, Politics, And Big Business Re-Create Race In The Twenty-First Century, Dorothy E. Roberts Jan 2011

Preface To Fatal Invention: How Science, Politics, And Big Business Re-Create Race In The Twenty-First Century, Dorothy E. Roberts

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Fatal Invention documents the emergence of a new biopolitics in the United States that relies on re-inventing race in biological terms using cutting-edge genomic science and biotechnologies. Some scientists are defining race as a biological category written in our genes, while the biotechnology and pharmaceutical industries convert the new racial science into race-based products, such as race-specific medicines, ancestry tests, and DNA forensics, that incorporate false assumptions of racial difference at the genetic level. The genetic understanding of race calls for technological responses to racial disparities while masking the continuing impact of racism in a supposedly post-racial society. Instead, I …