RockRat,
There is no black and white when it comes to rules. Even thou shall not kill, except in self-defense, to avert a worse disaster, or to kill infidels...
I think what Teva is doing is arguing with the FDA as to what the rules really mean, and why their results really do "functionally" and "practically" meet these criteria.
As we all know "equivalent" does not mean what it says, anymore then does the Clayton Act that states "there shall be no restraint of trade" (paraphrased but pretty close). Really, that would make all contracts an anti-trust violation because each contract restrains trade, and excludes others.
So Teva can make this argument based upon how they want the FDA to interpret their rules in relations to Teva's submission, and the FDA may never agree with them.
I think actually that it is in Teva's best interest for the FDA to remain as rigid as possible, and keep the barriers to approval as high as possible, in order to protect Copaxone which is also seeking approval through the ANDA process. But, as we've seen, they will argue for more flexibility on Lovenox and less on the impossible to characterize Copaxone (according to Teva).
Was Sanofi "lying" when they said it was impossible to characterize Lovenox? Given their patent application on Lovenox, perhaps, but probably not.
Tinker
AI
