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Friday, October 07, 2011 9:05:13 AM
Per Amphastar 2010 lawsuit against the FDA, they claim that the majority of their ANDA delay had to do with their heparin supply out of China. They also make mention in the suit that they had attained proof of sameness on Nov 2, 2007. (see pg 5, item 23)
The question is how did they prove that they attained sameness. Either they had used a process differing from Momenta's or a process similar to Momenta's, PRIOR to any patent approvals (so they didn't cheat, lie or steal) and subsequently, even if they did use the exact process that Momenta has patented, they probably can have the can have the patents rejected because of prior knowledge.
http://freepdfhosting.com/ec66abc083.pdf
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