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Re: mouton29 post# 12200

Monday, 07/21/2014 5:33:14 PM

Monday, July 21, 2014 5:33:14 PM

Post# of 20689
Thanks Mouton, I was mistaken in thinking the quote about a required process originating from the DC, thanks for correcting me. So as it stands now it certainly seems the CAFC will have to correct itself in that the FDA did not require only one test for approval. Would they actually consider correcting their own mistake based on additional information or is there some legal reason they couldn't revisit their own ruling (egos aside). In reading the Safe Harbor language it also seems that while Amphastar was protected in preparing their product for launch and could use the Momenta patent in preparation for approval, the ability to actually use the patent to allow production of product they are actually selling is a different story and appears to infringe. The case for Momenta seems strong at this point. It will be interesting to read the Amphastar rejoinder in mid August. Care to handicap? Regards and thanks for the discussion. bp