Stewart’s Denial of Institution on Two Amgen IPRs Highlights Possible Tension Between Drug Pricing, USPTO Priorities

In a recently-issued Director Discretionary Denial decision, U.S. Patent and Trademark Office (USPTO) Acting Director Coke Morgan Stewart denied institution of two petitions for inter partes review (IPR) brought by Amgen, Inc. against Bristol-Myers Squibb Company (BMS) but allowed institution in a third IPR.

The IPR petitions were brought by Amgen to challenge claims of three BMS patents: U.S. Patent 9,856,320; U.S. Patent 10,174,113; and U.S. Patent 11,332,529. The ‘320 patent  covers a method of administering immunotherapy to a patient; the ‘113 patent covers a method of treating a melanoma; and the ‘529 patent covers a method of treating colorectal cancer. The patents relate to BMS’s popular cancer drug, Opdivo. The related composition of matter patent expires in December 2028.

Amgen’s opposition to the requests for discretionary denial of the IPRs argued that the patents merely recite methods of administration and dosing that were publicly disclosed in the prior art and/or were the obvious choices. “Any differences between the claims of the ’529 Patent and the prior art are trivial, are within the ordinary skill in the art of treating cancer, and do not justify extending patent protection on Opdivo® by another nine years,” wrote Amgen in its opposition brief in IPR2025-00603.

In a short decision addressing the petitions on Thursday, Stewart explained that discretionary denial was warranted in IPR2025-00601 and IPR2025-00602 due to the number of years the patents have been in force (seven and six years, respectively), but was not in IPR2025-00603, where the patent has only been in force for three years.

While the lack of parallel proceedings in any of the IPRs weighed in favor of denying the petition for director discretionary denial, Stewart said the “settled expectations” of the patent owner in IPR2025-00601 and IPR2025-00602 outweigh this factor. “[T]he challenged patents have been in force for seven and six years, respectively, creating strong settled expectations for Patent Owner, and Petitioner does not provide persuasive reasoning why an inter partes review is an appropriate use of Board resources,” Stewart wrote.

‘Settled Expectations’ Under Scrutiny

Stewart has been issuing discretionary denial decisions based on the “settled expectations” standard since early June, a few months after the Office first announced a new interim process for Patent Trial and Appeal Board (PTAB) workload management. Under that process, the USPTO’s Acting Director exercises her discretion under 35 U.S.C. 314(a) and 324(a) to determine whether discretionary denial is appropriate for any petition for inter partes review (IPR) or post-grant review (PGR). Decisions on whether to institute an IPR or PGR are bifurcated between the discretionary considerations addressed by the Director and the merits and other statutory considerations. Stewart has said the aim of the change is to improve PTAB efficiency, to better allocate resources to reduce the pendency in ex parte appeals, and to promote consistent application of discretionary considerations in AIA proceedings.

While patent owners have been receptive to the change, petitioners have been critical. iRhythm Technologies, Inc., for instance, filed a petition for Director Review of Stewart’s June 6 Director Discretionary Denial decision denying institution of five inter partes reviews (IPR) it brought against Welch Allyn, Inc., claiming the decision has “unsettled the IP community.”

Drug Pricing Implications

According to Amgen’s brief, a decision to deny institution of its IPRs is counter to the United States’ economic interest in lowering drug prices, which has been a key focus of the Trump Administration, particularly via Trump’s Executive Order on “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients.”

Since Stewart’s memo contemplates taking into consideration issues including “compelling economic, public health, or national security interests,” Amgen’s opposition brief pointed to data showing that “‘patient and taxpayer spending on biologics increased from $100 billion to $260 billion (adjusted for inflation) over the last decade’…. Notably, biosimilars have been reported to consistently drive down drug costs, averaging more than 40 percent less than the reference brand at biosimilar launch, and providing $12.4 billion in savings in 2023.”

Opdivo may be selected as part of the Trump Administration’s first round of drug price negotiations under the Biden-era Inflation Reduction Act. According to reports, draft guidance of the Centers for Medicare and Medicaid Services indicates that “fixed-dose combination drugs” would be eligible for negotiations if it is determined that they do not have any “clinically meaningful difference” compared to the original drug.

Amgen also noted in its briefs that BMS’s attempts to patent the claims at issue in the IPRs have not fared well in Europe, with BMS voluntarily requesting revocation of the European equivalent to the ‘529 patent and extensive oppositions and rejections being filed in the other counterpart cases. “This rejection and capitulating withdrawal of similar claims in Europe reveals the Patent Office’s unmistakable error in allowing the challenged claims over prior art disclosing exactly what is recited in the claims,” wrote Amgen in its opposition brief in the 00601 IPR .

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