The ITC's Potential Role In Hatch-Waxman Litigation

Law360, New York (April 19, 2017, 12:21 PM EDT) -- Imagine a scenario where a branded pharmaceutical company holds U.S. patents claiming a process for making an active pharmaceutical ingredient, intermediates of the API, or the finished branded drug product. The process patents were not listed in the U.S. Food and Drug Administration’s Orange Book. The branded pharmaceutical company did not prevail in the abbreviated new drug application litigation over the patents that were listed in the Orange Book. The generic challenger together with foreign manufacturers have plans for the sale of imported batches of the...
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