USPTO Acting Director Denies Institution of Two Petitions for IPR Brought by Amgen Against Bristol-Myers, Allows Institution in Third IPR

USPTO Acting Director Denies Institution of Two Petitions for IPR Brought by Amgen Against Bristol-Myers, Allows Institution in Third IPR

According to Amgen, the patents merely recite methods of administration and dosing that were publicly revealed in the prior art and/or were the obvious choices.

US Patent and Trademark Office (USPTO) Acting Director Coke Morgan Stewart has 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.

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

According to Amgen, the patents merely recite methods of administration and dosing that were publicly revealed in the prior art and/or were the obvious choices. Amgen’s opposition brief reportedly states, “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.”

Addressing the petitions, Stewart said the 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 not warranted in IPR2025-00603 where the patent has only been in force for three years. Although the lack of parallel proceedings weighed in favor of institution, Stewart held that the “settled expectations” of the patent owner outweighed this factor.

Stewart reportedly wrote: “[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’s discretionary denial decisions rely on the “settled expectations” standard under a new interim USPTO process that aims to manage Patent Trial and Appeal Board (PTAB) workload, improve efficiency and ensure consistent application of discretionary considerations under 35 U.S.C. 314(a) and 324(a).

Meanwhile, Amgen argues that refusing institution of its IPRs works against the USA’s economic interest in lowering drug prices — an issue highlighted under the Biden-era Inflation Reduction Act and prior Trump Executive Orders. Amgen pointed to data showing that biosimilars consistently reduce drug costs by over 40% at launch, saving $12.4 billion in 2023 alone.

Amgen also noted that BMS’s attempts to patent similar claims in Europe have faced strong opposition, with BMS voluntarily revoking the European equivalent of the ‘529 patent.