Replies to post #92959 on Biotech Values

[DewDiligence]

It's not like NVS/MNTA can tell the FDA "Our drug is made using the same process that Teva uses - this we know for sure, because we stole their trade secrets."

However, this notion has already been planted by virtue of Teva’s filing its lawsuit, and I presume that FDA staffers are aware of some of the legal machinations in the Copaxone patent case. Such awareness could perhaps color the review process in NVS/MNTA’s favor, perhaps even subliminally.

Teva must have belatedly realized that alleging theft of Copaxone trade secrets was a losing game. These charges are no longer part of the ongoing litigation.

[DewDiligence]

…if you patent something, then you have to show how to enable the patent…

Right. These disclosures are presumably the starting point for MNTA’s claim of replicating the process.

Clearly the process is not fully disclosed in the patent, otherwise others without MNTA's technology could also copy it easily.

Notwithstanding the copious disclosures in the Copaxone patents, one presumably needs MNTA’s informatics tools—or some equally powerful toolset—to convert this knowledge into a full-fledged, commercial process.

Can another company do it? Perhaps, but MNTA wins big even if another company can do it. Unlike the NVS-MNTA agreement for Lovenox, MNTA shares Copaxone profits 50/50 with NVS regardless of how many approved generics reach the market. Moreover, NVS/MNTA have Hatch-Waxman first-filer status on Copaxone, which could be worth a lot in its own right.