Short Summary
Amgen seeks Director review of a denied institution for IPR2025‑00602, arguing that Bristol‑Myers Squibb’s Opdivo® flat‑dose patent is obvious and was improperly shielded by a discretionary denial based on settled expectations.
Detailed Summary
In a petition for Director review, Amgen challenges the PTAB’s discretionary denial of institution for IPR2025‑00602 concerning U.S. Patent No. 10,174,113, which claims a flat‑dose regimen of anti‑PD‑1 antibodies for treating melanoma. Amgen contends that the patent’s sole novel element—a fixed 240 mg or 480 mg dose—is anticipated by prior art (Wolchok, clinical studies) and therefore unpatentable under §§ 102 and 103. The petition highlights material errors demonstrated by European rejections of analogous claims, a recent disclaimer of related claims in the ’529 patent, and argues that the interim memo’s “settled expectations” factor was applied retroactively and unconstitutionally, violating Section 314(a). Amgen urges reversal of the denial and referral to a merits panel to protect public interest in accelerating biosimilar access to Opdivo®.
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before local courts. Understanding the court's reasoning in Amgen Inc. et al. vs Bristol-Myers Squibb Company is valuable context for structuring arguments or assessing risk in similar proceedings.
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