Replies to post #109415 on Biotech Values

[DewDiligence]

The Hatch-Waxman 30-month stay on final FDA approval of NVS/MNTA’s Copaxone ANDA expires in two months, at which time the Copaxone patent case and the Copaxone ANDA become fully independent of one another. Since the Copaxone patent case cannot possibly be resolved in the next two months, the patent case and the pending ANDA are already unrelated for all practical purposes.

If the FDA approves NVS/MNTA’s ANDA, Teva could file a lawsuit against the FDA as SNY has done for Lovenox, but such a suit would have no bearing on Teva’s patent case against NVS, MNTA, and MYL, or vice-versa.

[rkrw]

They can appeal the decision. Plenty of decisions get overturned on appeal. They'll also barrage the FDA with Citizens Petitions. Personally I think the FDA decision is more of a risk than the litigation.