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.
Related Cases
Amazon.com, Inc. et al.vsNokia Technologies Oy
Amazon and Nokia have settled their IPR dispute over U.S. Patent 10,536,714 and jointly moved to terminate the proceeding, requesting the settlement documents be kept confidential.
Amphenol CorporationvsCredo Technology Group Ltd.
Amphenol and Credo Technology Group settled four related IPRs before trial, leading the Board to terminate the proceedings and treat the settlement agreement as confidential business information.
Intel Corp. et al.vsGeneral Video, LLC
Intel, Dell and Dell Technologies have filed an IPR petition seeking to invalidate 30 claims of General Video's '437 patent covering serial video/audio transmission, arguing obviousness over Kim, Shin and Myers. The petition relies on expert testimony and cites multiple district‑court cases involving the patent.
Samsung Electronics America, Inc. et al.vsKoninklijke KPN N.V.
Samsung and Dutch telecom KPN have settled their IPR dispute over a location‑based services patent, filing a joint motion to terminate the proceeding.
USAA Federal Savings BankvsPACid Technologies, LLC
USAA has filed an IPR petition seeking cancellation of all 19 claims of PACid Technologies' ’771 patent on obviousness grounds, relying on a suite of prior‑art references covering biometric and cryptographic authentication.
Dealing with a patent challenge?
Whether it's a Section 3(d) rejection, a post-grant opposition, or a FRAND dispute, Arctic's patent litigation team has handled it. Get a strategy call.
Disclaimer: This page contains an automated summary based on publicly available judicial records. The content is generated for informational purposes only and does not constitute legal advice. Always verify details against the original source judgment before relying on this information for any legal purpose. If you believe any information is inaccurate, please contact us.