Thirty-one State AG's have filed an amicus brief with the US Supreme Court in favor of ending pay-for-delay deals between pharma innovators and generic producers. The AG's are backing the US Federal Trade Commission position that says these deals cost States and consumers dearly in increased healthcare costs. The FTC estimates the increased cost at approximately $3.5 B per year. The AMA has also come around to support the FTC position.
Drug manufacturers say the deals are legal and that they actually get generic drugs to market faster than might be possible otherwise. In fact the GMA (generics trade group), says the deals have never stopped a drug getting to market beyond a product's patent expiration date -- and in many cases months or years sooner.
Opponents counter that the deals prevent patent challenges and thereby weaken the patent system by allowing marginal patents to stand. This in turn allows holders of those patents to maintain a monopoly position witha drug longer than they might otherwise -- and this is anticompetitive.
So far, lower courts have sided both ways. The 3rd, 6th and DC Circuits have generally ruled to make pay-for-delay harder, and the 2nd, 11th and Federal Circuits have made rulings more likely to allow pay-for-delay. Normally, the US prefers to have law that is a bit more consistent across the land, so the Supreme court is being asked to review the issue. But will they hear the case and break the ties? Hard to say.
Posted by Bruce Lehr Nov 15th 2012.