Replies to post #129005 on Biotech Values

[floblu14]

Dew - if MNTA can prove beyond doubt that Amphastar infringed MNTA's patent, can the FDA rescind Amphastar's approval? TIA

[mcbio]

Based on MNTA’s limited expedited discovery, MNTA told the Court yesterday that Amphastar does infringe MNTA’s ‘466 patent, which covers the 1,6 anhydro structural component of Lovenox that the FDA said is a requirement for showing sameness to branded Lovenox.

Based on the same expedited discovery, MNTA also told the Court that Amphastar does not infringe on MNTA’s ‘886 patent, so you no longer need to worry about the claims in that patent.

Do you feel like the prospects for a settlement are likely off the table, or at least close to it, at this point? I assume a settlement would occur prior to the judge's decision and, since that could have come yesterday, it strikes me as MNTA being willing to roll the dice on the PI. (I'm fine with that, of course.) There's still time for a settlement now with the TRO extended but it's presumably going to take a change in MNTA's sentiment for this to occur.

[jb_118]

Based on MNTA’s limited expedited discovery, MNTA told the Court yesterday that Amphastar does infringe MNTA’s ‘466 patent, which covers the 1,6 anhydro structural component of Lovenox that the FDA said is a requirement for showing sameness to branded Lovenox.

How do you parse the below statement from Amphastar with the above assertion?

A. Plaintiffs Have No Evidence Of Infringement
In spite of having moved for a TRO/preliminary injunction on the ground that Defendants are infringing the ’466 patent, Plaintiffs have not responded at all to Defendants arguments and evidence that there is no infringement of the ’466 patent based on a fundamental fact that the FDA never asked Amphastar to perform any release testing for sequencing of tetrasaccharides. Significantly, Plaintiffs have not responded to Defendants’ point that Plaintiffs have not presented evidence that there is an actual FDA requirement for tetrasaccharide sequencing.