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.
>>But generally Momenta's only description of those sugars is a description of them as whatever causes Peak 9 in a CE plot. Is this specific enough... or not? Note that they are also somewhat unspecific about exactly what the signature is. <<
Clark, Did you look at figure 1a from the '886 patent?
The plot is milli-absorbance units over time. I'm thinking that's signature enough, because it probably is unique. Would love to get more color on that thought from actual bench scientists like PGS or winchem.