Biotech Values

[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.