MNTA/TEVA—What if there is no way to analytically characterize enox to FDA standard w out infringing on one [MNTA’s] patents? Teva could try to copy their science but would be infringing and couldn't get to market. Under this scenario, the FDA could approve other generics but they couldn't get to market due to the IP.
This is a problem Teva would be happy to have :- ) In the actual situation, Teva is presumably not using MNTA’s proprietary technology else their ANDA would have been approved by now.