On July 24, 2025, the PTO Acting Director Coke Morgan Stewart discretionarily denied Amgen’s IPR2025-00601 and IPR2025-00602 challenging Bristol-Myers Squibb’s (“BMS”) U.S. Patent Nos. 9,856,320 (“the ’320 patent”) and 10,174,113 (“the ’113 patent”) respectively, related to BMS’s Opdivo® (nivolumab) and Yervoy® (ipilimumab). A third IPR, IPR2025-00603 challenging BMS’s U.S. Patent No. 11,332,529 (“the ’529 patent”) was not denied by the Acting Director for discretionary reasons and instead was referred to the Board for a review as to whether it should be instituted on the merits. Amgen is currently developing a biosimilar of Opdivo®, referred to as ABP 206.
In the decision denying institution, the Acting Director stated that the IPRs were denied based on a totality of the arguments presented in the case, but pointed specifically to the “strong settled expectations of the Patent Owner” in the ’320 and ’113 patents given they had been in force for six and seven years respectively. In contrast, the Director found the ’529 patent did not have the same strongly settled expectations given it had only been in force for three years. The Director’s focus on this issue is somewhat surprising as it was not a main argument in the briefing and was only alluded to by the Patent Owner in a few sentences and a parenthetical citation.[1]
Unlike in many of the previous discretionary denials, the patents at issue in these IPRs are not subject to parallel litigation between the parties given that Amgen has not yet filed an aBLA for ABP 206 and a BPCIA litigation has not yet been filed. The Acting Director noted that this fact weighed against discretionary denial, but still ultimately concluded discretionary denial was appropriate. The Director’s decision to deny institution is not appealable.
As noted previously (Samsung Bioepis and Formycon’s EYLEA® IPRs Discretionarily Denied Institution Among Wave of Fintiv Denials; Regeneron Files Second BPCIA Lawsuit Against Amgen’s Pavblu™), there has been a wave of discretionary denials after the Acting Director rescinded a previous guidance memorandum (“Interim Procedure”) from former Director Vidal concerning the discretionary denial standard under Fintiv and issued a new guidance memorandum (“Guidance on USPTO’s recission of ‘Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation’”) and Interim Process for PTAB Workload Management in March 2025. The Interim Process outlined factors that would be considered by the Director, including “[s]ettled expectations of the parties, such as the length of time the claims have been in force.”
Patent Owners and Petitioners should take note that the reasoning for these discretionary denials pointed specifically to the settled expectations of the Patent Owner in the validity of its patents, given it has not been a basis that has previously been cited as a reason for discretionary denial of biosimilar-related IPRs. These decisions may signal that under the current guidance, the settled expectations are a particularly strong consideration for the Acting Director. This change could make it more difficult for biosimilar applicants to navigate the timing for filing early IPRs given that filing too early may prevent standing for an appeal. See ModernaTx Inc. v. Arbutus Biopharma Corp., 18 F.4th 1364 (Fed. Cir. 2021); Momenta Pharms, Inc. v. Bristol-Myers Squibb Co., 915 F.3d 764, 766 (Fed. Cir. 2019)). This could mean that IPRs may become less useful for biosimilar manufacturers if the patents they are challenging have not been issued very recently.
Bristol-Myers Squibb reported U.S. sales of $5.35B for Opdivo® in 2024.
For more information about these and other biosimilars and biosimilar disputes, please visit BiologicsHQ.
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The author would like to thank April Breyer Menon for her contributions to this article.
[1] See e.g. IPR2025-00601 Patent Owner Request for Discretionary Denial, Paper 6 at 42-42 (P.T.A.B. Jun. 10, 2025) (emphasis added): “The ’320 Patent issued more than seven years ago on January 2, 2018. EX1001. Its related family members were the subject of well-publicized litigation between BMS and AstraZeneca beginning in March 2022. EX2020 (providing a link to complaint); EX2021 (complaint asserting patents in Cogswell family). Had Amgen wanted to avoid addressing the ’320 Patent through the BPCIA, it could have filed its IPR much sooner—it began Phase III clinical trials of its OPDIVO® biosimilar on July 26, 2023. EX2006; see also Irhythm Techs., Inc. v. Welch Allyn, Inc., IPR2025-00363, Paper 10 at 3 (P.T.A.B. Jun. 6, 2025) (exercising discretion to deny institution based on settled expectations of the parties).”
Notably the IPR2025-00603 briefing did not contain the single sentence stating when the patent issued, which appears to be what the Acting Director relied on in determining discretionary denial was appropriate in IPR2025-00601 and IPR2025-00602.
