Replies to post #5955 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

…it would probably be possible for SNY to launch a generic without violating [MNTA’s Lovenox patents]

SNY’s authorized generic (should they choose to launch one) would in all likelihood be simply branded Lovenox with different packaging, so MNTA’s patents would not be in play.

[kaivamei]

the FDA roadmap for approval runs right through the middle of territory defended by MNTA's patents

True, but Amphastar's complaint, which was posted here yesterday (and which they also withdrew yesterday), argued in part that their enox should be approved because it FDA scientists had considered it approvable
(and were about to approve it) some time before the new MNTA-inspired FDA guidelines were instituted. They claimed the FDA had "moved the goalposts" (I recall this was a phrase their lawyers had used).

So isn't it at least theoretically possible that the FDA approved their enox on the basis of a "grandfathering" or rolling back to previous guidelines that were in place when their application was first evaluated?

If this is so (and I do hope it is not), it would potentially vitiate the basis for MNTA's suit.

Any thoughts on why this would be outside the realm of possibility?