Why would Sandoz have to give notice to TEVA of launching copaxone if FDA approves??????? at all???
I presume the judge is familiar with FDA action date - spring 2011, and there is some pressure to wrap up the suit before than - if not, Sandoz could launch at risk and force the courts to expedite the patent dispute together with any injuction suit filed by TEVA.
This news actually is consequential, but not for the reason most investors think. On a recent webcast (#msg-54378320), Teva’s Bill Marth told investors that, following the Court’s denial of NVS/MNTA’s request for a summary judgment based on indefiniteness, the Copaxone case was effectively decided in Teva’s favor already and that Teva would probably ask the Court for a summary judgment that all of its patents are valid and infringed.
Well, since Marth made those comments about a month ago, there has been no motion by Teva for a summary judgment. Instead, we now know that Teva has been negotiating with NVS as to how much advance notice Teva will receive when NVS launches generic Copaxone.
Why is this notable? Because there’s no way in hell NVS would launch without a favorable outcome to the patent case in the District Court. (NVS might launch at-risk prior to a decision by the appellate court, however.) In other words, Teva would have no reason to be concerned about receiving advance notice of NVS’ launch unless Teva thought they might lose the patent case.