Amgen Inc. v. Bristol-Myers Squibb Co.

Informative decision only: persuasive authority, not binding precedent. When a patent has been in force only about three years (here, issued in 2022), a patent owner may still have strong settled expectations that favor discretionary denial under 35 U.S.C. § 314(a), but it must articulate why, for example by explaining how an extraordinary amount of investment, time, and resources dedicated to research, development, trials, and regulatory approval correlates to settled expectations. Absent that showing, the Director found no strong settled expectations for the three-year-old patent and referred the petition to the Board, whereas for patents in force for six and seven years the Director found strong settled expectations and denied institution. No prior precedent directly addressed this issue in the text; the decision cites Dabico Airport Sols. Inc. v. AXA Power ApS, IPR2025-00408, Paper 21 at 2–3 (Director June 18, 2025), only for the point that a petitioner must give persuasive reasoning why an inter partes review is an appropriate use of Board resources. For petitioners, patents in force six or seven years carry strong settled expectations, so the petitioner must supply persuasive reasoning why review is an appropriate use of Board resources, and without it institution is denied. For patent owners, a patent in force about three years is not automatically without settled expectations, but the owner must affirmatively explain, for example with investment and regulatory-approval evidence, why its expectations are strong; here the owner failed to do so and lost on that factor for the 2022 patent. The decision cites no Federal Circuit or Supreme Court authority. LEGAL TEST OR STANDARD: Discretionary denial under 35 U.S.C. § 314(a) is decided on the totality of the evidence and a holistic assessment of all arguments. Factors discussed: whether a parallel proceeding exists (inconsistent outcomes and duplicated effort); how long the patent has been in force and whether the patent owner has strong settled expectations; and whether the petitioner gives persuasive reasoning why inter partes review is an appropriate use of Board resources. The decision does not list numbered factors. TRIGGERING FACTS: No parallel proceeding involving the challenged patents existed, which counseled against denial. The patent in IPR2025-00603 issued in 2022 (three years in force), and the patent owner did not sufficiently articulate reasons for strong settled expectations, so the petition was referred to the Board. The patents in IPR2025-00601 and IPR2025-00602 had been in force seven and six years, creating strong settled expectations, and the petitioner gave no persuasive reasoning for using Board resources, so institution was denied. Arguments under the Biologics Price Competition and Innovation Act from both parties were not persuasive. KEY QUOTE: "Although there may be good reasons why a patent owner has strong settled expectations in a patent that has only been in force for three years, for example an explanation of how an extraordinary amount of investment, time, and resources dedicated to research, development, trials, and regulatory approval correlates to settled expectations, Patent Owner has not sufficiently articulated such reasons in these proceedings." (Paper 9, p. 2) PRIOR PRECEDENT AFFECTED: Follows Dabico Airport Sols. Inc. v. AXA Power ApS, IPR2025-00408, Paper 21 at 2–3 (Director June 18, 2025), for the requirement that the petitioner provide persuasive reasoning why an inter partes review is an appropriate use of Board resources. No other prior precedential or informative decision is named. PRACTICE TIP: Patent owners with a relatively young patent should put in the discretionary-denial request concrete evidence tying investment, time, resources, research, development, trials, and regulatory approval to their settled expectations, rather than relying on patent age alone. Petitioners challenging patents in force six years or more should include affirmative reasoning in the opposition why review is an appropriate use of Board resources.