Momenta Pharmaceuticals, Inc. (MNTA)

[biopearl]

Mouton and stockbetter, thanks for posting the pertinent briefs re ongoing lovenox litigation. Mouton, your statement,

<<Unless I am missing something, though, in the end, the court concludes that the patented test is in fact required because it is in the USP (emphasis added): >> My question is this:

Just because a procedure for manufacture is listed in the USP, is its use "required" for approval? If so this would not comport with Momenta using an entirely different test (2D NMR) for their approval. So do you see this finding by the DC as strong?

As I read through the brief I am reminded that the ruling was only on an injunction, and that Ampahstar withheld data from the court and was sanctioned.

So unlike the copaxone case where the CAFC ruling will still be in force at the time of FDA approval (whenever that is...) the lovonox case is different in that only the injunction is in force but the case not as yet determined. Is this correct and if so in this case is there a legitimate chance for treble damages in favor of Momenta since it may be found that Momenta's patent was indeed violated? Thanks and regards, bp