The Need for Clarity After <i>Sandoz v Amgen</i>

Amanda Forys, MSPH: Back in June, the Supreme Court made a ruling on the case of Sandoz v Amgen, which clarified some issues around the so-called BPCIA (Biologics Price Competition and Innovation Act) “patent dance.” This has left some other questions unanswered. What clarifications are biosimilar developers looking for now? What did they get from that? And, what about innovators?

Ha Kung Wong, JD: We talked a little bit about this earlier. The 2 aspects of the “patent dance,” as we call it, and this BPCIA litigation pathway for biosimilars that was impacted by the Supreme Court decision was, first of all, the aspect of, what happens if you don’t give them the biosimilar application? The second part of it was, what happens with the 2 lists of patents that you narrow down to in this pathway? In one, you litigate right away. The other one is keyed off with this commercial manufacturing notice. That question was kind of answered by the Supreme Court. They can actually give that notice any time they want, even if it’s not an FDA approved product. So, I’ll put that aside.

The real question that people are looking for clarification on is, what has to be done in order to get the BPCIA process going? Right now, it looks like it may be optional. There is one aspect of it that was remanded back to the Federal Circuit, and that was whether state law injunctions can be used to enforce the BPCIA. All the Supreme Court said was that federal injunctions can’t be used. So, that is a question. And then, the second question is, if so, is it preempted? The United States actually filed a brief saying, “Yes, it’s preempted.” Clearly, they think they preempt everything, so it’s not really a surprise. But, it will be something that people will look at, pretty carefully, to see if there is still life in the BPCIA litigation pathway.

And the second aspect is, we talked about total noncompliance. “I’m not going to give you the application.” “I’m not going to give you my manufacturing information.” “Come sue me.” But what happens if I just give you the application and I don’t give you the manufacturing information? So, let’s say “partial noncompliance.” Well, so far, it looks like according to Amgen v Hospira, and some other things we’ve seen, that you’re left with the same problem. “You don’t get to start the BPCIA pathway.” “Go sue me.” They go and get a declaratory judgment action. So, again, Congress’s intent, I think, was thwarted. You kind of see the ambiguity in the language and the statute.

Let’s talk about an even stickier situation. What does manufacturing information mean? “How much do I have to give?” “I don’t know.” So, maybe I, as a biosimilar manufacturer, gave my application. I gave my manufacturing information, but it’s not enough. Does that mean that I have to get sued? Or, does that mean I get to go into the BPCIA pathway? Who knows. Those are all open questions. A lot of people are looking for clarification. I’m not sure that the courts are going to be able to clarify it. It might come down to Congress.

Angus Worthing, MD, FACR, FACP: I appreciate your talking about the “patent dance” a little bit, Ha Kung. As a rheumatologist taking care of people, what was meaningful to me was the first part where you mentioned that because it’s now simple and you put it aside, the notification can start at any time, which means that I’ll learn about a drug when it’s FDA approved, generally. It will entice patients and doctors to find out more information about it. And the sooner that that drug can be available after the FDA approval date, the better to improve communication and education. And then, it’s also refreshing that the marketplace is working and the drugs can come out quicker and safer.

Ha Kung Wong, JD: The interesting point, here, is that the reason why biosimilars wanted to give notice early was not because they wanted to market the drug earlier. It’s because they wanted to trigger the litigation on a second set of patents, earlier. So, it was actually kind of looking at ways to manipulate the statute to trigger more litigation, earlier. That’s not necessarily a bad thing. I’m just saying that when you say, “I’m going to give 180-day commercial marketing notice,” you’d think that you’d have something to commercially market. You can’t just say, “Hey guys, I plan to make this drug sometime in the future. Here’s your notice. I’m going to market it someday.” But the Court said, “That’s okay.” So, it’s okay.