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Full-Text Articles in Law
Faster Resolutions In Tariff Classification Litigation: Using Patent Law As A Model, Lawrence Friedman
Faster Resolutions In Tariff Classification Litigation: Using Patent Law As A Model, Lawrence Friedman
Lawrence Friedman
This article draws a previously unmade analogy between patent litigation and customs cases before the U.S. Court of International Trade. The article posits that tariff classification litigation can be made more efficient by inverting the current focus on developing the facts through discovery and, instead, moving quickly to resolve controlling questions of law through motions for partial summary judgment, court-annexed mediation, or, if necessary, revised rules of procedure.
Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork
Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork
Michigan Telecommunications & Technology Law Review
Similarity is an elusive and complicated concept facing comparisons of biological molecules, as even minute changes to a molecule's structure can dramatically affect its function in the body. Yet the flood of biologic drugs on the market will increasingly force these similarity comparisons. These concerns are particularly relevant to two groups of drugs: families of biologic drugs that closely resemble each other in structure and function, here termed "similar-impact biologics," and the biosimilars, which are intended to closely approximate generic forms of biologic drugs. In bringing biologic drugs to the market, manufacturers are likely to face dual obstacles: FDA approval …