Imron Aly, JD, partner at Schiff Hardin LLP, discusses the impact of listing patents in the FDA's Purple Book.
How might including patents in the Purple Book affect developers?
For generics point of view, putting patent information in the Purple Book would be a huge improvement to the status quo. Right now, there’s a lot of uncertainty about what patens 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?
I would add 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. 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.