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Alexandra Valenti, JD: Experience With BPCIA Litigation


Alexandra Valenti, JD, associate at Goodwin, discusses how Biologics Price Competition and Innovation Act (BPCIA) litigation has evolved with greater experience.


So, [Biologics Price Competition and Innovation Act, BPCIA] litigation, I wouldn’t say it’s gotten any smoother. Some fundamental questions about how to interpret the statute have now been answered by the federal circuit and the Supreme Court, which certainly leaves fewer unanswered questions that can come up in a district court case.

However, these cases are still very complex. They involve many patents, many more patents than are typical in small-molecule Hatch-Waxman cases, and that has, attendant to it, further complexities in the case. There are usually more experts involved in these cases. The sheer volume of these patents just leads to more proceedings and takes longer to resolve.

And so, these cases are typically taking much longer than we saw on average in the Hatch-Waxman space. So, I wouldn’t say they’re going any smoother or less smooth, but certainly remain very complex litigations to undertake.

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