Momenta Pharmaceuticals, Inc. (MNTA)

[mouton29]

I would need to go back and do some more review to answer your questions fully, but here are some partial answers:

<<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?>>

I quoted from the CAFC, so I'm not sure this was a "finding by the DC." But it certainly seems wrong -- either it is wrong or Momenta not properly manufacturing product. But the error is irrelevant to the CAFC conclusion, they specifically say that even if the Momenta test is not the only one required, the use of the Momenta test is still protected by the safe harbor. Now that's obviously a broader holding, so I suppose it increases the probability of Supreme Court review.

You are correct that the CAFC ruling was "only" on the injunction, but of course what is now being appealed is the summary judgment by the DC on the merits. So if the CAFC affirms that, it's all over, unless the Supreme's agree to review.