In other words, the FDA’s five criteria for “sameness” ...are merely a starting point—they are necessary but not sufficient to obtain FDA approval for a generic version of Lovenox.
Right, and isn't MNTA's suit against Teva, in essence, an attempt to prevent TEVA from infringing on MNTA's ability to accurately characterize the molecule (and others) because MNTA has patented the technology to do this in a way that has not been done before? That ability to characterize would also be the primary reason that the FDA went to momenta during the contamination crisis, N'cest, pas?
aj
