Short Summary
Amgen petitions the PTAB to overturn a Director’s denial of institution for an IPR challenging Bristol‑Myers Squibb’s Opdivo dosing patent, arguing the denial misapplied settled‑expectations criteria and ignored European claim abandonments.
Detailed Summary
Amgen Inc. filed a Request for Director Review seeking reversal of the PTAB Director’s discretionary denial to institute an inter partes review of U.S. Patent No. 9,856,320, which covers dosing regimens for the cancer drug Opdivo®. The petition contends that the Director improperly relied on a newly introduced "settled expectations" factor, failed to consider the patent owner’s surrender of nearly identical claims in Europe, ignored a recent disclaimer of a related patent, and overlooked the public interest in accelerating biosimilar availability. Citing prior art such as clinical trial NCT01024231 and European applications, Amgen argues the patent is obvious and that the denial violates statutory and constitutional limits. The request asks the Director to reverse the denial and refer the case to a merits panel.
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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