Momenta Pharmaceuticals, Inc. (MNTA)

[investorgold2002]

jb-you asked: "What makes you think that Amphastar is infringing on Momenta's patents?"


Momenta was the "pathfinder" or "pathsetter" for equivalence criteria for generic lovenox. There is some truth to that. Testament to that is MNTA filed ANDA 2 years later in 2005 and got approved much earlier. I am repeating what the bean counter stated in the last cc. So some of those equivalence criteria including testing for below was probably a "path" "set" by MNTA that may have been initially missing in Ampha's ANDA which explains the delay in their ANDA approval.
Take an example

EQUIVALENCE CRITERIA:
" for determining that a defined percentage of the oligosaccharidechains that make up enoxaparin include, at their reducing ends, a non-naturally occurring sugar that includes a 1,6-anhydro ring structure, whichmethod infringes the '886 patent; and(b) "

MNTA'S IP ON HOW TO PROVE THE ABOVE EQUIVALENCE CRITERIA:

"providing an enoxaparin sample that has been exhaustively digested with two or more heparin degrading enzymes; using a separation method to determine, in the enoxaparin sample that has been contacted with two or more heparin degrading enzymes, the presence of a structural signature associated with the non naturally occurring sugar associated with peak 9 of FIG. 1" "


Now another thing I would like to add is MNTA's other IP on heparin...example: Contamination control patent or Oxidation process patent...Although they are not the patents in suit now, IMO they have a good potential of getting added to this suit post discovery because I think Ampha or it's suppliers may likely be infringing on those?