>This is not about the FDA action. FDA has the right to approve drugs regardless of whether they have patent protection.<
Following Thomas’s line of thinking: If I were arguing the case for Teva/Amphastar, I would assert that SNY’s fraudulently obtained patent materially delayed a decision by Teva and Amphastar to even consider a development program for a generic version of Lovenox. Were it not for the fraud, Teva and Amphastar might have filed ANDA’s several years earlier and these ANDA’s might have been approved by now.
The pitfall of such an argument is that Teva and Amphastar would not have stood to make much money if SNY’s Lovenox patent in question had never issued; under such circumstances, there would presumably have been multiple generic companies in the market from the outset.
As you noted, this will be an interesting case to follow.
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