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Articles 1 - 4 of 4
Full-Text Articles in Intellectual Property Law
I Want A New (Generic) Drug: A Comparative Case For Shifting U.S. Generic Drug Policies To Increase Availability And Lower Healthcare Costs, Immer S. Chriswell
I Want A New (Generic) Drug: A Comparative Case For Shifting U.S. Generic Drug Policies To Increase Availability And Lower Healthcare Costs, Immer S. Chriswell
Northwestern Journal of International Law & Business
Enacted in 1984, Hatch-Waxman was intended to increase generic drug availability and make critical healthcare more affordable for Americans. In the nearly forty years following, while it has increased availability of drugs, it has also allowed drug originators to create avenues to profit in ways not intended when the original compromise was struck, undermining its success. Moreover, given a weak antitrust standard against reverse settlement payments proscribed in Actavis, the U.S. faces a dilemma to further improve access to generic medications in the future. The E.U.’s approach to generic drugs, while presently geographically fragmented, is simpler and has a clear …
Can The Law Track Scientific Risk And Technological Innovation?: The Problem Of Regulatory Definitions And Nanotechnology, David A. Dana
Can The Law Track Scientific Risk And Technological Innovation?: The Problem Of Regulatory Definitions And Nanotechnology, David A. Dana
Faculty Working Papers
The functioning of a regulatory regime often turns on what is defined to be included in the scope of regulation and what is defined to be outside. In constructing the definitions of what is regulated, two key challenges are to align the defintions with the risks that motivated the establishment of the regulatory regime and to build in dynamism into the defintions so that they adapt to changes in scientific understanding and technology. This Chapter of a forthcoming book from Cambridge University Press (David Dana, ed., The Nanotechnology Challenge), explores these challnegs in the context of nanotechnology.
The Contextual Rationality Of The Precautionary Principle, David A. Dana
The Contextual Rationality Of The Precautionary Principle, David A. Dana
Faculty Working Papers
This article defines the precautionary principle (PP) primarily based on what it is not: it is not quantitative cost-benefit analysis (CBA) or cost-cost analysis of the sort we associate with the Office of Management and Budget in the United States and U.S. policymaking and policy discourse generally. In this definition, the PP is a form of analysis in which the costs of a possible environmental or health risk are not quantified, or if they are, any quantification is likely to be inadequate to capture the full extent of the costs of not taking regulatory measures to mitigate or avoid the …
General Exclusion Orders Under Section 337, Gary M. Hnath
General Exclusion Orders Under Section 337, Gary M. Hnath
Northwestern Journal of International Law & Business
Your company, Widgets Unlimited, imports foreign-made widgets into the United States. One day, you're informed that U.S. Customs & Border Protection (Customs) has detained your goods and is determining whether they infringe a patent owned by The American Widget Corporation, based on an exclusion order issued by the International Trade Commission (ITC) after a recent ITC investigation, titled Certain Widgets with Extra Shiny Surfaces. Since you were never a party to any proceeding at the ITC, and indeed, you never even knew American Widget had patents on its widgets, you conclude that there must be some mistake and wait for …