Abbott may now claim that the BPCIA will induce the FDA to run afoul of the takings clause in the Fifth Amendment but revealing its trade secrets to competitors without compensation, but Rep Eshoo, one of the Bill's authors, says Abbott never said a word when the bill was being drafted.
Further she says, it was Congressional intent to apply BPCIA to all biologics -- both prior and after the Bill's March 23, 2010 passage. And the Bill was specifically designed to allow competitors to go after big multi-billion biologics that would be coming off patent soon -- so the Government and patients could realize savings. She says, Abbott was privy to all this information in real-time and never raised an objection in conference. See Patent Docs blog.
One must conclude that Abbott likely had its legal strategy in its pocket and planned to spring it whenever the time seemed opportune. Now, we'll have to see how the FDA responds -- for or against the Citizen Petition Will that depend on who wins the next Presidential Election?
Posted by Bruce Lehr Oct 26th 2012.