Imron Aly, JD, partner at Schiff Hardin, LLP, discusses key trends emerging in Biologics Price Competition and Innovation Act (BPCIA) litigation.
In our growing experience with the Biologics Price Competition and Innovation Act, are there some trends that you’ve seen emerging?
Yes, there are. The key trend is that there’s no need to go through a regulatory pathway, to first go through the FDA, and then go through the litigation at the district court level. So, what we’ve seen over and over is an opportunity to identify patents of interest, and then go to court on declaratory judgement actions right away. That’s the way to get to the market sooner and at least get the patent issues resolved—perhaps before investing the millions of dollars required for the regulatory side.