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HDGabor

03/29/15 9:35 AM

#46152 RE: alwayswatching1 #46149

NCE does not have ANY relation to SPA / ANCHOR. If NCE will be granted (I think it will) it won't prove anything or help in case of the SPA or ANCHOR.

The primary reason is time:
a.) w NCE, ANDAs should be withdrawn / refused by FDA, could not be resubmitted before 07/26/2016 and approved before 7/26/2017 (except some special case, but it isn't a case here)
b.) if ANDAs will request a dismiss of the (current) patent case, new case will be started after new ANDA submission (after 7/26/2016) and the automatic 30-months stay will be started again -> generic could be marketed by 1/26/2020 as earliest (unless the court will invalidate the patents during this 30 months earlier - I do not think)
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rafunrafun

03/29/15 9:43 AM

#46154 RE: alwayswatching1 #46149

Lucky for AMRN, they have a top notch attorney who will give them the right advice. I'll piggyback and add a few more questions/topics to consider...

1. Can AMRN sue for SPA, ever though they didn't exhaust all appeals, even though it's idiotic to do so, because each appeal ultimately goes through the commissioner.

2. If AMRN does sue for SPA, can they get same judge? The reasoning would be that he's so familiar with these two, why waste time and resources to re-educate another judge.

3. As HD has been saying all along, if REDUCE-IT results are right around the corner, what's even the point of SPA.