On July 24, 2025, Acting Director of the USPTO, Coke Morgan Stewart, denied institution of inter partes review in IPR2025-00601 and IPR2025-00602, but referred the petition in IPR2025-00603 to the Board in Amgen Inc. v. Bristol-Myers Squibb Co. The Bristol-Myers Squibb ("BMS") patents, challenged by Petitioner Amgen, relate to methods of treating cancer with a combination of an anti-PD-1 antibody and an anti-CTLA-4 antibody.
In choosing to refer the petition in -00603, Stewart noted that the parties are not currently engaged in a parallel proceeding, and the challenged patent has not been in force for a significant amount of time, having issued in 2022.
In Patent Owner's Discretionary Denial Brief, BMS raised several points about the BPCIA, arguing that the Director should deny institution because Amgen's challenges will be resolved through the BPCIA proceedings. Specifically, BMS argued that the exchanges under the Patent Dance are "statutorily mandated by the BPCIA regardless of whether an IPR is instituted and they culminate in the filing of a complaint in district court," and that "an IPR based on this Petition will guarantee duplicative proceedings and waste PTO resources." IPR2025-00603, Patent Owner's Discretionary Denial Brief, at 2–3.
In response, Amgen addressed Patent Owner BMS's arguments on the BPCIA, emphasizing the length of time the proceedings would take: "This voluntary Patent Exchange can take approximately ten months to complete before an infringement action under the BPCIA is filed. Once filed, the average time for a decision on the merits by the district court in BPCIA cases is 2.5–3.5 years. By contrast, a Final Written Decision in this IPR would be issued by October of 2026—likely years earlier than any resolution via the BPCIA procedures." IPR2025-00603, Petitioner's Opp., at 3.
Moreover, Amgen warned of a potential chilling effect on IPR filings: "PO's argument would preclude all biosimilar manufacturers from ever filing an IPR as all biosimilar products developed to date have faced the potential for BPCIA litigation. The mere possibility of future litigation should not deprive biosimilar developers of access to IPRs to efficiently challenge clearly unpatentable claims while still in the process of preparing to file aBLAs to secure FDA approval to sell their products in the United States." Id. at 4.
Additionally, Amgen raised a policy argument that biosimilars allow the public to potentially access less expensive treatment options for treatment, and IPRs play a critical role in the process, which would weigh against denial. See id. Amgen also compared the continued availability of IPR proceedings to the "settled expectations" of biosimilar manufacturers, a factor that has been increasingly addressed in the Acting Director's recent decisions. See id. at 5.
Stay tuned to Big Molecule Watch and Goodwin's PTAB Trial Tracker as we continue to monitor the latest biosimilars developments.
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