Intellectual Property Practice Group Co-Leader Imron Aly was quoted on how including patents in the U.S. Food and Drug Administration’s “Purple Book” — which lists biological products, including any biosimilar and interchangeable biological products — might affect developers.
“From a generics point of view, putting patent information in the Purple Book would be a huge improvement to the status quo,” Imron said. “Right now, there’s a lot of uncertainty about what patents could be asserted, when they would be asserted, and even how they would be asserted. We’ve heard a lot about the patent dance in literature and publications, but having that listing, much like there’s already that Orange Book for small molecules, would really give guidance to the generics to see what are the patents, what are the expiration dates, and what is a pathway to get to a generic biologic?”
He added, “From a brand point of view, it would also be very helpful, because they would have certainty as well about which patents apply to which products, and therefore can put up their own hurdles in terms of what patent information they would like to have listed.”
“Finally, there is one challenge having information on the Purple Book like the Orange Book, and that is so many biologics patents are process patents, how to make the biologic, or tools to get to the biologic,” Imron said. “That’s very different because the Orange Book currently does not allow for listing of process patents, and therefore those aren’t in the Orange Book at all. That would be a big difference to keep an eye out for.”
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