The Importance Of Options In Biosimilar Litigation

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

Last year around this time, I was on vacation, desperately hoping the FDA would not choose that one week of the year to release its long-awaited interchangeability guidelines. Little did any of us know, the agency was about seven months away from doing so. But this year, as I settled into my beach chair at the Outer Banks, it was impossible to stray far from the biosimilar space.

Last Monday, the Supreme Court came back with its ruling on the highly debated Amgen v. Sandoz, siding unanimously with Sandoz. The patent dance is to remain optional (though there are still possibilities state law could get involved), and biosimilar companies do not have to wait until approval to provide 180 days of marketing notice.

Within the last month or so, Biosimilar Development has published several installments of a roundtable discussion with experts from different legal firms. (In case you’ve missed them, they can be found here, here, and here.) Of course, these roundtables began with a focus on the now-resolved Amgen v. Sandoz. However, prior to my leaving for vacation, I also wrote two articles based off the most recent AtlanticLive biosimilar policy update. This program featured a panel discussion amongst experts from Momenta, Eli Lilly, and Foley & Lardner, focused primarily on Amgen v. Sandoz.

Though many of you likely have your own opinions on how the Supreme Court should have voted (as this panel proved), I found the diversity of opinions worthy of discussion. In particular, the most valuable portion of the conversation came at the end of the session, during which the experts shared their Amgen v. Sandoz predictions and touched upon other legal concerns in the biosimilar space.

How “Shall” Become The Most Important Word In Biosimilars

The nerdy former English major in me never ceases to enjoy how important the seemingly simple word “shall” has become within this scientific industry. Though the small molecule generics market survived and still faces legal strife today, I think many would agree the biosimilar industry’s fixation on one word has surprised all stakeholders involved. In fact, as Bruce Artim, senior director of federal government affairs from Eli Lilly, explained, the Biologics Price Competition and Innovation Act’s (BPCIA’s) approval was a somewhat unique case.

The lead sponsor of the BPCIA was Senator Ted Kennedy, who completed a draft of the bill in 2007. At the same time, there was also a parallel set of legislation being crafted in the House to usher in biosimilars. However, following Kennedy’s untimely death in 2009, members of Congress decided to adopt Kennedy’s bipartisan bill. Because of reconciliation rules, “Congress had to take the language or leave it,” said Artim. So, ultimately, “What was passed was the 2007 version, in many respects. In a normal situation, I think this language would’ve been refined so you wouldn’t have, [for instance, Supreme Court] Justice Pryor asking if the FDA could fill in some of these gaps.”

We all likely have varying levels of familiarity with Amgen v. Sandoz. Prior to the Supreme Court, the Federal Circuit ruled that “shall” made it optional for biosimilar companies to share their biosimilar applications with brand companies, especially because the legislation spells out consequences for not sharing this information. However, in the case of the 180-day pre-marketing notice, the Federal Circuit ruled the biosimilar companies could only provide commercial notice upon receiving approval from the FDA, not before. Courtenay Brinckerhoff, a partner for Foley & Lardner, put it best when she explained, “Shall does not really mean shall in the first issue. But shall does mean shall in the second issue.”

Are IPRs Poised To Steal Legal Spotlight Post- Amgen v. Sandoz?

Though Brinckerhoff correctly predicted the Supreme Court would keep the patent dance optional, she argued it would be much harder to predict the outcome of the pre-marketing notice portion of the case. Protests against high drug prices seem to reach new heights every week. As such, “There’s a lot of public interest in believing the [biosimilar] products should be marketed as soon as they’re approved,” Brinckerhoff said. “The statute is pretty black-and-white, but the expectations were different.” In the end, to brand companies’ chagrin, the Supreme Court eliminated that extra six-month cushion.

As for the biosimilar and originator sides, both of which had voices on this panel, their expectations for the patent dance issue were in keeping with their business interests. Phil Nickson, associate general counsel, intellectual property for biosimilar maker Momenta, argued in favor of keeping the patent dance optional, while Lilly’s Artim predicted the dance would be deemed mandatory because the Supreme Court has regularly overturned Federal Circuit rulings in the past. However, he also wouldn’t have been surprised had the Court dismissed the case as improvidently granted, especially because of the amount of angst displayed by several justices during the hearing. (Luckily, for biosimilar makers, neither of these predictions came to fruition.)

But Artim also carried the conversation away from Amgen v. Sandoz to another increasingly prominent legal challenge: The Inter-Partes Review (IPR) process. Established by the America Invents Act (AIA) of 2012, the IPR process has become quite popular in the biosimilar space because it is a cheaper, more efficient means of patent litigation. The process owes its efficiency to the fact that proceedings conducted by the Patent Trial and Appeal Board (PTAB) require a lower standard of evidence than the Federal Courts. For biosimilar makers, this has its perks; for originators, the lower standard of evidence is quite controversial.

Artim quite emphatically argued the IPR standard of evidence needs to be reviewed. In fact, following Nickson’s support of IPRs for biosimilars, Artim struck up what could’ve been an interesting debate, had there been more time to venture further into discussion. “Why does it need to be a lower standard of evidence than the Federal Courts,” Artim asked. “Why would we not give deference to the originator, which spent billions on preclinical and clinical development and whose drug made it to market and became one of the two-in-10 drugs that actually earns its money back?... We believe the rule for biologics and biosimilars should be clear and convincing evidence. That’s what it is for every other patent in the Federal courts.” 

Now, seeing as I’m not a lawyer, nor am I defending patents from other companies, I’m unable to speak at length on the merits or downfalls of a lower standard of evidence. However, given the predicament the biosimilar space currently is in, with biosimilars being approved but held up in the courts, there’s certainly something to be said for a process that could help a company cover some legal ground more quickly and cost-effectively.

As Nickson argued, “We need to separate those patents that protect new cures from those that are designed to delay patient access to biosimilars. There are certain patents out there for certain molecules that don’t protect new cures but are designed to delay patient access through abuse of litigation.” This is why he believes biosimilar companies should have the choice to engage in the patent dance on a case-by-case basis. “Choice is a good thing,” he offered.

Though Nickson was speaking about the patent dance and not IPRs, his emphasis on having options for patent battles also rang true for IPRs. When it comes to litigation, especially in these early biosimilar days, having a choice of legal strategies is key. And, judging from its recent ruling, the Supreme Court seems to find options integral for moving the biosimilar industry forward, as well.