north40000, dew, tinkershaw - feel free to weigh in on this thread. TIA
I am trying to understand if any other company can satisfy the 5 criteria(esp II,III.1 , III.2) listed in FDA's CP response to Aventis and yet not be able to infringe on the 2 patents momenta holds on characterization of lovenox....the claims seem pretty general and seems that any company trying to characterize lovenox would infringe on momenta's patents(For example:methods they used to prove III.1 and III.2 like compositional analysis,SAX-HPLC...So does TEVA have to come up with new methods to prove III.1 and III.2???)
...on the other hand as rockrat mentioned could such general claims hold up to a challenge? one would think that momenta's attorneys would have thought through this..
Here is my "basic" understanding of Lovenox characterization by Momenta .there are 2 parts to it, if u will
1. Starting material signature of UFH(which includes among other p's, the p8 that was found for the 1st time)
2. Signature caused by process in this case mode of depolymerization which leads "1,6 anhydro ring structure at the reducing ends of the oligosaccharide chains"
Controlling the starting material and Controlling process conditions of depolymerization, would basically yield equivalent product.