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Robert Cerwinski: Hatch-Waxman Litigation of Follow-On Insulins


Robert Cerwinski, JD, partner at Goodwin, explains why Hatch-Waxman litigation may provide a smoother path than does the Biologics Price Competition and Innovation Act.


FDA granted tentative approval to Merck for an insulin glargine follow-on pending the outcome of Hatch-Waxman litigation; does the fact that FDA regulates insulin as a drug have an impact on the litigation process?

I think it does. The Hatch-Waxman laws were enacted in 1984 and we’ve had a lot of practice with these litigations in the district courts and appellate courts, and the metes and bounds and contours of the Hatch-Waxman laws have been pretty well defined through decades of adjudication. It’s a pretty rapid and efficient timeline from [Abbreviated New Drug Application, ANDA] filing to final resolution of the appeal—pretty well-oiled litigation procedure. We have a lot more uncertainty with the [Biologics Price Competition and Innovation Act, BPCIA]. It’s a new statute, courts are just adjudicating it now for the first time, and we are seeing a lot of—I wouldn’t say confusion—but a lot of testing of the gray areas of the statute, for example, with Amgen v Hospira. Litigants are really trying to take advantage of every perceived advantage in the statue and are bringing motions and are litigating those. So, the pace of litigation is likely to be quite a bit slower in the context of the BPCIA, at least initially. Also, we see a lot more patents typically being brought to bear in and BPCIA litigation. So, the fact that Lantus is being brought along this sort of well-oiled generic drug litigation track, I think [that] in general, although the specifics will vary from case to case, I think that in general that’s going to be a faster timeline right now, than BPCIA litigation.

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