I been pondering this below for awhile and thought I'd get it out of my head and down to the board:
Could TEVA/AIS have two versions of the epi-pen available?
I ponder this because the litigation in the works evolves (evolved) around two patents held by Meridian, the holder of approved NDA # 019-430, the “Epi-Pen” widely marketed and used today.
The two patents are, the ‘012, "Automatic Injector" (issued 11/11/2008)and the ‘432 patent, "Automatic Injector with Kickback Attenuation", issued 9/14/2010.
We know that King/Meridian, et. al filed a motion to dismiss the ‘012 patent, subsequently after the Markham hearing in which the Court ruled in favor of TEVA regarding King’s claims of infringement on ‘one or more’ claims. Case dismissed.
The ‘432 patent infringement continues as we know. The next trial date is Wednesday, March 6th and probably or may be wrapped up in two days total. We know from the Markham hearing that the Court was (imo) just about equally split between each parties claims. And we know now that TEVA/AIS have or are changing, tweaking this particular pen. Is that to address the individual claims? Is that to produce a “stand alone” pen version and not a true generic?
Now I ask myself, does TEVA/AIS already have a pen ready to go market based on the dismissal of the ‘012 patent once FDA gives approval?
Do they have another pen that is being or has been changed to potentially have ready to go to market based on a positive outcome in the ‘432 patent case?
Is the dual mentality displayed by Antares with the two dose submittal to the FDA for Anturol in play here?
jab9