Sunday, March 29, 2015 9:35:54 AM
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a.) w NCE, ANDAs should be withdrawn / refused by FDA, could not be resubmitted before 07/26/2016 and approved before 7/26/2017 (except some special case, but it isn't a case here)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)
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a.) w NCE, ANDAs should be withdrawn / refused by FDA, could not be resubmitted before 07/26/2016 and approved before 7/26/2017 (except some special case, but it isn't a case here)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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