Kevin M. Nelson, JD: Federal Circuit Decision Brings Clarity to Early Case Assessment for Biosimilar Applicants

Last week’s ruling in the federal circuit, which held that state law cannot compel biosimilar applicants to participate in the Biologics Price Competition and Innovation Act (BPCIA) “patent dance,” has raised questions about how the case will impact the BPCIA in the days ahead. Yet Kevin M. Nelson, JD, partner at Schiff Hardin’s Hatch-Waxman and biosimilars practice, told The Center for Biosimilars^® in an interview, that, “For the BPCIA, I don’t think it means much.” In Nelson’s view, the most significant impact that the ruling will have is on the early case assessments that biosimilar applicants undertake when determining whether they will take part in the information exchange process.

“When we walk to clients about whether to play in this space,” said Nelson, “one of the things we talk about is early case assessment; that means not only deciding what type of compound to look at…but also looking at the legal or regulatory landscape.” Part of that assessment is understanding the types of disclosures that a company will have to make in the context of BPCIA litigation. “What this opinion did,” Nelson said, “is lent certainty to 1 variable that previously was uncertain for biosimilar competitors.” Biosimilar applicants will now have a more definite understanding concerning the types of information that they will be required to disclose if they choose to participate in the so-called patent dance, and will also have a choice as to whether to engage in the patent dance.

Nelson states that there are still good reasons to participate in the information-exchange process: “It allows [biosimilar developers] to have some sort of certainty as far as patents that are going to be at issue in the litigation, and some control over the second phase—that litigation phase. They know the patents that are at issue, they know the potential for an injunction. If they refuse to participate in the patent dance, they get the benefit of speeding up the process, which is good, but they don’t get the benefit of that certainty and being able to control that second phase.” While there are no guarantees that this greater level of clarity will result in speedier BPCIA litigation, “that’s the hope,” said Nelson.

While the federal circuit’s ruling lent certainty to this area of interest to biosimilar stakeholders, there may still be room for further clarification to the BPICA from the US Congress. “I think it will undergo changes the longer we have it around,” said Nelson. “If you look at Hatch-Waxman, that was implemented in the mid 1980s, and it underwent a substantial revision in 2003…and after 2003, we still saw some tinkerings around the edge, mainly by the FDA. I don’t think we’ve heard the last of changes to the BPCIA. We’d be foolish to think it’s perfect and right the first time out of the box. Everything can and should be improved.”

Asked whether the FDA may begin to make its voice heard on BPCIA issues in the way that it did on Hatch-Waxman, Nelson thinks that the FDA may become more vocal in the future. “I think FDA is waiting for the structure [of the BPCIA] to be at least a little more solidified…before it starts to put in its technical expertise. However, FDA has made some important determinations in the realm of biosimilars…FDA has given a little bit of guidance that has allowed us to have a little bit of clarity from a scientific and regulatory perceptive, and I think we’ll see more of that.”

In light of the federal circuit’s ruling and the clarity that it brings to administration of the BPCIA, Nelson said, “I think we’re going to see more scientific guidance from the FDA and more technical guidance, especially form the payer’s side, so I think this decision…will really pave the way for a little more clarity each day in the biosimilars area.”