There has been legislation introduced recently to change the provisions as to how the 180‑day award for being a first filer in a paragraph IV patent challenge works. The FDA has proposed some alternate changes as well, outlined in a current blog by our friend Kurt Karst (here). If you want your head to spin (and it will), take a read at what may be inserted into the legislative hopper.
Karst professes that the proposed FDA change will make things easier for the FDA to deal with the complexity of the exclusivity forfeiture provisions of the Act, and, while that may be the case, I say too bad, FDA. It might be easier for you but upsetting the delicate balance struck by Hatch‑Waxman, which has been tinkered with before, is why you (FDA) are in this pickle. Taking the value out of or potentially diminishing the value of the 180‑day incentive is not the answer. It would result in fewer firms seeking to challenge patents that could bring generics to market faster because the boatload of money for doing so will not be a reasonable value proposition if the challenger cannot expect a return on its efforts.
If you, FDA, need to make it easier to make these decisions, then find another way. Don’t further erode one of the few potential sources of real value in generic drug approvals before the industry’s profit margin drops to an even lower level and firms are forced to stop manufacturing certain drug products altogether. I say, good for you, Kurt Karst, for blowing the whistle on this foolhardy idea.
