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Full-Text Articles in Law
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
All Faculty Scholarship
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 …
Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch
Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch
Journal of Health Care Law and Policy
No abstract provided.
Follow-On Biologics: Legal, Scientific, And Policy Considerations, Jeremiah L. Kelly
Follow-On Biologics: Legal, Scientific, And Policy Considerations, Jeremiah L. Kelly
Journal of Health Care Law and Policy
No abstract provided.