Replies to post #127075 on Biotech Values

[exwannabe]

One issue for MNTA here is timing - could be that the Amphastar process predates the MNTA patents.

It might be well documented in the FDA CMC paperwork, so the issue could be at the trial.

As a technical point, is it not the date of the MNTA invention, and not the patent application, that matters?

[mcbio]

The couple of percent deals tend to be settlements. The injunctions are always from successful lawsuits.

Thanks very much. That makes perfect sense.

One issue for MNTA here is timing - could be that the Amphastar process predates the MNTA patents.

But if they are using a process that they never got a patent on and that violates MNTA's patented process, I assume timing wouldn't be an issue.

[iwfal]

MNTA -

One issue for MNTA here is timing - could be that the Amphastar process predates the MNTA patents.

Could be - but one of the two patents dates from 2003 and I believe that the FDA guidance on sameness criteria was after that. So it is plausible that Momenta got there first.

Even for the later patent, it is clear that the FDA was refining its needs over the last 5 years and thus Momenta could have patented before Amphastar implemented. But I do think the 2003 patent seems most likely to pass your hurdle.