One of the primary incentives provided in the BPCIA to engage in the “patent dance” is that if the applicant completes the dance and the reference product sponsor does not sue that 30-day period, as required by statue, infringement damages for patents that could have been asserted are limited to a reasonable royalty. So the patent dance, which takes about 6 months, in order to narrow down to those 2 lists, is designed in part as a vehicle to provide patent certainty for biosimilar applicants fairly early in the process, rather than allowing a reference product sponsor to bring suits later and potentially complicate the biosimilar launch process.
But with Sandoz, we’ve already seen that some biosimilar applicants would prefer to forego the patent dance entirely. Currently, the biosimilars in late-stage development are for blockbuster drugs that have been on the market since the 1990s. And because they’ve been on the market for so long, many are covered by only a handful of unexpired patents. So under those circumstances, biosimilar applicants may not see any incentive to participate in this dance.
With Amgen’s Humira biosimilar, on the other hand, we’ve seen them engage in the BPCIA disclosures and set up this 2-stage litigation. And in that case, Amgen would likely have decided to participate in the patent dance with AbbVie if their application had been accepted by the FDA after the Supreme Court’s ruling with Sandoz.
The reason why, is because AbbVie has close to 100 patents on Humira, some covering methods of use, some covering formulations, and some covering process technologies. Some of those patents may be more important than others, and Amgen might have likely liked to use the BPCIA to kind of narrow the patents at issue—make sure they know which ones are the most important. Now, in that scenario, both the BLA holder and the biosimilar gains additional certainty.
Going forward, though, biosimilar applicants will begin targeting newer drugs not long after data exclusivity expires. Under those circumstances, with larger patent portfolios and longer expiration dates, the certainty that the patent dance provides could be valuable to biosimilar applicants.
And last, keep in mind that whether the biosimilar applicant is looking to get an interchangeable biosimilar may also impact their strategy, as interchangeables carry the additional incentive of potential exclusivity. And the FDA did release a new guidance this year, talking about what they might require to get interchangeable. So that may be the carrot that everyone’s looking for.