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Monday, October 09, 2017 12:31:43 PM
If ITC rules wrong jurisdiction it goes to FDA.
If ITC rules the complaint is not cognizant due to inability to determine drug status it goes to FDA.
If the FDA fails to properly enforce laws at the request of Amarin, it is arbitrary and capricious "regulation". The answer here is yes, it is arbitrary and capricious. Next question, what are the damages done to Amarin for the FDA's failure to act? IMO this moves into a phase of discussions regarding NCE, ANCHOR, First Amendment and now the additional failure to apply laws to imported drugs that cross into Amarin's IP and new drug application. The damages to the above actions and inactions are cognizant under a "takings" claim against the United States. Amarin wins this law suit IMO if the FDA fails to act on ITC "loss".
I do not think Amarin will lose ITC action, but if they do the FDA is on-the-hook.
BB
Mr. McGee, don't make me angry. You wouldn't like me when I'm angry---David Banner
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