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?
This just my opinion but if they DONT have a pen ready for marketing or extremely close then they are being very short sighted. Another reason it would be smart to have two pens or perhaps more with minor deviations. What is the compromise is fine you can make generic pens BUT the design has to be IDENTICAL to the Pfizer one? Or if they dont make that stipulation and AIS has a better design BAM we get to show the market how we can improve on the pen and do better than big bad Pfizer :)
They must have a pen ready to go to market based on the '012 patent case dismissal. Just waiting for FDA approval.
And why not another pen based on or one that addresses the '432 patent litigation.
After all, Meridian has two pens.
Now back to what's the most important topic - unsubstantiated rumors and personality clashes.
Did you hear the rumor that I'm going to bid on Antares? I just have to find the capital - a minor issue and hurdle to get over. Look for a future/new SEC 13G/A filing for the "KouJabTapDelRyDaug Yahoo Board Capital Fund" for a majority share stock purchase.
Disclosure: I just made that up folks. Happy Friday and a good weekend.