Elaine Blais, JD, partner at Goodwin and head of the litigation department in Goodwin’s Boston office, discusses whether a recent spate of patent settlements related to biosimilars reflects a shift away from lengthy Biologics Price Competition and Innovation Act (BPCIA) litigation.
It’s hard to say whether the number of settlements in the biosimilars arena indicate a shift away from lengthy BPCIA litigation. Many of those settlements have been entered into after litigation that some would probably say was lengthy.
And I think it’s a little too early to know how this will shake out. There’s a couple factors at play: One is that the courts and the [Federal Trade Commission, FTC] and Congress have started to pay more attention to settlements in the biosimilar space. We could see activity from anyone of those bodies or from the plaintiff’s bar that might discourage settlements going forward.
We could also see changes in the ways these cases are managed by the courts, or in the risks that both biosimilars manufacturers and the brands face that might impact whether settlements take place. Because of course, generally speaking, a settlement happens when both parties have risks.