Wow..
The NCE period of exclusion is defined by HW, an act of congress. The NCE period is not arbitrary, not altered by the circumstances or the time in which it is determined. There have been many cases (many of them cited in our our NCE trial) when then NCE was not determined at the time of the NDA, but at a much later date. In all cases the NCE ran from the date the NDA was approved until five years later which is specified in HW.
The five year period commencing at the time of drug approval is not alterable by FDA or a federal judge, it is indeed set in stone until the time congress determines otherwise. The reason is related to fairness, not only to the sponsor, but also the generics. Why should they be punished by having to wait a longer time, because the FDA erred, or simply could not make up its mind.
HDG was right a bunch of deafs...
":>) JL
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