FDA’s “Holding On The Merits” Test

Law360, New York (April 21, 2006, 12:00 AM EDT) -- In the latest development relating to the triggering of the 180-day generic marketing exclusivity period, the U.S. District Court for the District of Columbia upheld the Food & Drug Administration’s (“FDA”) April 11, 2006 letter ruling, in which FDA adopted a new “holding on the merits” test. In its letter ruling, FDA determined that only a decision on the merits holding the brand company’s patent invalid, unenforceable or not infringed, will trigger the running of the 180-day generic exclusivity period. FDA rejected the argument that a...
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