In Amgen Inc. v. Bristol-Myers Squibb Company, IPR2025-00603, Paper 8 (PTAB Jul. 24, 2025), the Acting USPTO Director Coke Morgan Stewart denied institution in two IPRs where the challenged patents had been in force for at least six years, but referred the third—IPR2025-00603—to the Board for further consideration, because the challenged patent had only been in force for three years. However, in doing so the Director provided guidance as to the sorts of arguments the patent holder could have made to support settled expectations for a young patent.
The Director found that the patents challenged in IPR2025-00601 and IPR2025-00602—issued seven and six years ago, respectively—had developed "strong settled expectations" that weighed against institution. In contrast, the patent challenged in IPR2025-00603 was issued in 2022 and thus only three years old. Although the IPR in this instance was referred, the Acting Director acknowledged that even young patents may support settled expectations, explaining that "an extraordinary amount of investment, time, and resources dedicated to research, development, trials, and regulatory approval" could support settled expectations. But since Patent Owner had not sufficiently articulated such reasons, IPR2025-00603 was referred.
This decision provides valuable guidance for practitioners where the patent owner is seeking discretionary denial for younger patents based on settled expectations. For patents under six years old, "settled expectations" are not impossible, but the bar is higher: detailed evidence, such as the examples given of investments, is required. Both parties should pay careful attention to what sort of evidence is available to show such investments.
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