Nicholas Mitrokostas, JD, Responds to Changes to IPRs in the Biosimilars Context

While all eyes were on the Supreme Court of the United States’ ruling in the much-anticipated Oil States Energy Services, LLC, v Greene’s Energy Group, LLC, the Court issued a second key ruling this week in SAS Institute v Iancu, Director, United States Patent and Trademark Office, et al—one that will also impact inter partes review (IPR) of biologic drug patents.

The SAS Institute case concerned whether the Patent and Trademark Office (PTO) could choose to institute IPR proceedings on some claims made by a petitioner and deny the review of other claims on a patent. On Tuesday of this week, the Court ruled that, when the PTO institutes an IPR, it must decide on the patentability of all challenged claims.

In essence, in determining whether to institute an IPR, the Patent Trial and Appeal Board (PTAB) finds at least 1 claim that could potentially be found unpatentable under the appropriate standard, then the PTAB must address the patentability of all of the claims challenged by the petitioner.

Nicholas Mitrokostas, JD, partner in Goodwin’s intellectual property litigation group, told The Center for Biosimilars^® in an interview that this ruling is unlikely to extend the timeline for the IPR process, because the PTAB is required to issue a written decision within 1 year of instituting an IPR.

However, the ruling could result in the PTAB issuing shorter institution decisions; to date, PTAB has explained on a claim-by-claim basis whether a review will be instituted, and has explained where the petitioner may not have met its burden for demonstrating why a review should be instituted. Given the fact that the PTAB will now have to address all claims in its written decision, it may choose to provide shorter institution decisions if it is only required to address 1 claim at that time. “If that’s the case, it’ll be interesting for petitioners who won’t have a sense of where the panel is focused with respect to each of the claims…I think there are still a lot of open questions as to how the PTAB is going to change its practice in institution decisions moving forward.”

In terms of practicalities, Mitrokostas suggested that it is unlikely that biosimilar developers will seek to challenge more numerous claims on patents in light of the ruling, because claims raised in IPRs may limit arguments that can later be raised in district court. “There are estoppel consequences with respect to what arguments could be presented by the petitioner in …a later district court litigation,” Mitrokostas said, and to that end, biosimilar developers will have to strategically consider which claims to challenge.

From the reference product sponsor’s perspective, “One of the consequences of this decision is that there’s more risk associate with an IPR in the sense that, in the past, the patent owner could be in a position where not all of the claims were subject to review,” and that fact “would give the patent owner some comfort the sense that they would know at the end of an IPR proceeding, they could lose some of their claims, but not all of their claims.” This week’s ruling means there is now a higher risk of having all claims found unpatentable. That fact, says Mitrokostas, could result in more pre-decision settlements between reference biologics sponsors and biosimilar developers.