Minneapolis patent attorney Jim Nelson of Schwegman, Lundberg & Woessner explains how business can navigate the challenges of BioSimilars.
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Well, the first thing and most important thing, I think, is to petition the congress, our federal legislature to change the litigation rules for biosimilars. I think there needs to be some governmental oversight in this initial process about who’s supposed to submit what when. And I think like the small molecules like pharmaceuticals, I think that there needs to be a book that lists all the patents that cover the biological. Now, the FDA has said that it is producing such a book. It’s called the Purple Book. But if you look on the FDA website, the Purple Book’s a blank page. There’s nothing in it ’cause, for one thing, there aren’t an approved biosimilars, although there are many, many biologicals that are approved, but there’s no federal requirement, federal law that requires the sponsor of the biological to list all the patents that cover the biologicals. No law like that. And so, of course, the biologicals aren’t gonna do that. What they’re gonna say is, “Ah, you’re a biosimilar. Well, you got to figure it out yourself. All right? And then when it comes time, we’ll spring things on ya.” So it’s the battle. That’s the battle. So that’s the first thing.
Second thing that a biosimilar can do is make sure that the analytical and functional information that they are going to deliver to the FDA gives the FDA enough information that the FDA is able to go forward. Now, the FDA has a separate group that is an advisory group that will review your information as you’re developing it and will tell you, “Well, I don’t think this is enough.” And so my advice is very early on you need to become associated with this advisory group at the FDA. And it’s not the approval group. It’s a separate group at the FDA. Become associated with this advisory group and periodically, every month talk to the advisory group about what you’re doing, what you should do, and what you need to do in order to get approval of the analytical and functional requirements for the biosimilar’s approval. That way you’re not finishing up your analytical and functional database only to find out that you have to go back to the beginning. Work with the FDA.
Last thing I would say is patent your material. Absolutely 110-percent important. You might think, “Well, I’m making the same thing as the sponsor is making. Why should I patent it?” Hey, your stuff is not the same thing. Remember the wine analogy? The wine from Rutherford Vineyards is not the same as the cabernet from, say, St. Julian and the Bordeaux Region in France. Not the same thing, although they have allegedly the same kinds of grapes and the same percentage of grape varieties that are in the wine. Not the same thing. So you have something different. Your process is different, the side products are different. They’re not different enough to kick you out of the biosimilar situation, but they’re different. And so you ought to patent it too. Why? Because other biosimilars will come along and will use your information as a way to piggyback into the sales of their biological. They’re gonna use yours and the sponsor’s information.