Replies to post #128339 on Biotech Values

[iwfal]

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.

Presumably you say this because they couldn't have known about the patent until issue date (2009 and 2010)? Ok, but even before knowing of the patents they may have chosen to steer away from what they viewed as cumbersome routine testing for other reasons - like saving process time and/or $ (I presume the tests MNTA references in the patents are quite time consuming when done on a batch by batch basis).

Several other comments:

1) It wouldn't surprise me if they had to do full testing only on SOME batches or, for instance, every n months - and for the rest the run records (time/temp) plus proxies would be adequate. Somewhat like instrument calibration for electrical test equipment isn't done every hour - but is instead scheduled for every x days/weeks.

2) It also wouldn't surprise me if they decided to do the same test using a different technology (e.g. claim 1 of 466 calls specifically for testing using "strong anion exchange HPLC") - but the neighboring claims provide a variety of other techniques (e.g. claim 2 of 466 call for doing the same test using "fast protein liquid chromatography").

In both of the above cases I could also see a company (e.g. Amphastar) attempting to redact data using the above as excuses. "well, this (proxy) is what we use every batch - and the other stuff (call it a calibration run) is only done for regulatory reasons")