Biotech Values

[DewDiligence]

…we don't know if Amphastar actually went down this path or not, but the fact that they are now citing the R&D exemption suggests that they might have.

If they did, they would have had to submit an amendment to the ANDA as MNTA has done to circumvent Teva’s “Gad” patents in its Copaxone ANDA.

In the lawsuit Amphastar filed against the FDA, there is no evidence or even a suggestion that Amphastar submitted such an amendment. Hence, my guess is that Amphastar did not submit one and your premise about an easy workaround to MNTA’s Lovenox patents is flawed.

We should know more about this one way or the other if the Judge allows limited expedited discovery. Regards, Dew