Regulation, Policy, and Litigation in Biosimilars - Episode 14
Amanda Forys, MSPH: We talked earlier about the Pfizer lawsuit against Johnson & Johnson. What other litigation should we be looking toward in the coming months as an industry?
Ha Kung Wong, JD: Every “patent geek” out there is looking at the pending Supreme Court case with Oil States Energy Services. The reason is, Oil States is looking at whether the IPR (inter partes review) process is even constitutional. The fact of the matter is, they’re looking at whether patents are considered private property. And if it’s private property, whether it can be extinguished by anything other than an Article III court. If that’s the case, that it can’t be extinguished by anything but an Article III court. Then, the PTAB (Patent Trial and Appeal Board), being a regulatory agency, so to speak, can’t do it. That means that everything that we’ve seen cancelled in the last 5 to 6 years, suddenly pops back to life. That would be very interesting. That would change the dynamic of IP (intellectual property) litigation, dramatically. A lot of challengers have been looking to this IPR process in the PTAB, in lieu of litigation, because it’s cheaper and faster. If that goes away, not only will we suddenly have all of these patents that are now back as invalid, but it will change the way people move forward in the future, as well.
The other case that I will mention is that there’s an Amgen-Sanofi case that looks at the use of permanent injunctions in drug patent disputes. I think it will be interesting to see how that turns out, because it will significantly impact biosimilar applicants and whether they want an at-risk launch or not, assuming that the regulatory exclusivity has already been completed. And then, the Amgen v Hospira case actually talks about whether the ramp up and making of the product, and warehousing of the biosimilar product in advance of launching it is something that’s under safe harbor or not. The question there is whether safe harbor actually applies to commercial batches of a biosimilar that’s prepared prior to launch. And in that case, Hospira has manufactured over 20 million doses with a commercial value of hundreds of millions of dollars. They say, “It’s solely for uses reasonably related to the development and submission of information to the FDA. So, therefore, it’s safe harbored.” But is it? I don’t know. And if it isn’t, that could be significantly damaging.
Amanda Forys, MSPH: Dr. Worthing, let’s talk a little bit about all of the litigation and the complexities around that. The bottom line is patient access, right? Ultimately, you want to get patients to products faster. You want to give safe products as soon as possible. What are the concerns, not just with this patent litigation, but other cases you see coming to market around anticompetitive behavior? What is the ultimate effect for that on your patient population?
Angus Worthing, MD, FACR, FACP: Well, to tell you the truth, we don’t talk too much about lawsuits in the clinic. But the overall effect of a delay in the courts or in litigation, of which I have learned a lot about on this panel, I appreciate. The net effect of all of that is that there’s a delay in getting drugs that might be cheaper. People might have an easier time getting control of their disease, their aching joints, and their other organs that might be inflamed. I’ll just register that there’s a little bit of frustration about it. Doctors appreciate the innovation that helps us, and the tools that we can use to take care of patients. But I think a lot of us want to just see the new drugs come out, so that we can use them, if they’re safe and effective, and meet our bar.
Amanda Forys, MSPH: How many of your patients are walking in your office knowing what a biosimilar is, or are following this? What percent of your patients actually know that Inflectra (infliximab) is available? Or, that Renflexis (infliximab-abda) is coming out and could be a potential therapy for them to switch over to?
Angus Worthing, MD, FACR, FACP: Good question. I have the pleasure of practicing in Washington, DC, downtown on K Street. A lot of people are actually involved in the healthcare business and in policy. Some of them are actually people who know a lot about biosimilars, or even more than me. But for the average patient, I’m taking some extra time in a lot of my visits to tell people who are taking a biologic about what a biosimilar is and a little bit about the marketplace. Then, they know. They might do some research—if they’re interested when the time comes or when we might be deciding, together, to move to a biosimilar. But not too many people have heard about them.
Ha Kung Wong, JD: Let me add one thing in respect to patent litigations and its impact on consumer access to biologics. I want to make note that the BPCIA pathway, like the Hatch-Waxman pathway before it, was meant to sort out all of the IP issues prior to the approval of the generic or biosimilar. It was meant to not delay the access, but to actually be done during the regulatory stay period. In the Hatch-Waxman context, that would be the 30-month regulatory stay. In the BPCIA pathway, it would be this kind of new biologic entity, a 12-years stay on approval. In essence, although patent litigation could take a long time, what actually slows things down is not the litigation, itself. Patent litigation can be slow, but it’s usually not 8 years slow. Typically, it’s actually the regulatory exclusivity that will slow it down. After you have the 12 years, you may have another 6 months, and you can kind of go on from there.
I’m not saying that there aren’t instances in which the regulatory stay has been extinguished, and that litigation is ongoing and could cause some issues with timing. But I’m saying that in a typical process, the BPCIA was meant to actually expedite the litigation, to make sure it’s done early on, so it doesn’t slow the access of the biosimilar to the marketplace. Then, all of those IP issues are sorted out and it doesn’t end up being a situation where someone has to launch, at-risk, or go for a preliminary injunction.