Biotech Values

[iwfal]

MNTA -

One issue for MNTA here is timing - could be that the Amphastar process predates the MNTA patents.

Could be - but one of the two patents dates from 2003 and I believe that the FDA guidance on sameness criteria was after that. So it is plausible that Momenta got there first.

Even for the later patent, it is clear that the FDA was refining its needs over the last 5 years and thus Momenta could have patented before Amphastar implemented. But I do think the 2003 patent seems most likely to pass your hurdle.