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pollyvonwog

09/23/11 2:12 PM

#127220 RE: ghmm #127219

International Medical Systems is a subsidiary of Amphastar that makes injectables
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DewDiligence

09/23/11 2:14 PM

#127222 RE: ghmm #127219

...I was a tad surprised the FDA was not named as a defendant since they likely were influenced by Momenta technology (based on the 5 criteria)…

The FDA can’t be sued for patent infringement. They can be sued for malfeasance, but it’s not clear that the FDA did anything wrong by publishing the approval criteria for generic Lovenox, even if those criteria were taken directly from MNTA’s patents.

In short, naming the FDA as a defendant would have been a serious mistake, IMO.