The detailed information for PTAB case with proceeding number IPR2025-00603 filed by Amgen Inc. et al. against Bristol-Myers Squibb Company on Feb 28, 2025. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2025-00603
Filing Date
Feb 28, 2025
Petitioner
Amgen Inc. et al.
Respondent
Bristol-Myers Squibb Company
Status
Preliminary response waived
Respondent Application Number
16306290
Respondent Tech Center
1600
Respondent Patent Number
11332529

Proceeding Documents

The table below shows documents filed in the case, listing each document name, filing date, document type, and filing party. Tracking these filings indicates the activity of the parties involved in the case, and the types of documents filed can provide insights into the legal strategies being employed.


Document NameFiling DateCategoryFiling Party

Alert me when new update on this case

Director Discretionary Decision: Refer

Jul 24, 2025PAPERBOARD

OPDIVO FDA Approval label and prescribing information, December 2014

Jul 10, 2025EXHIBITPETITIONER

Commemorating the 15th Anniversary of the Biologics Price Competition and Innovation Act, FDA.gov

Jul 10, 2025EXHIBITPETITIONER

Patent Term Extension certificate for U.S. Patent No. 8,008,449

Jul 10, 2025EXHIBITPETITIONER

Notice of Final Determination Eligible for U.S. Patent No. 8,008,449

Jul 10, 2025EXHIBITPETITIONER

U.S. Patent No. 9,358,289

Jul 10, 2025EXHIBITPETITIONER

Bristol-Myers Squibb Company Form 10-K (Dec. 31, 2024)

Jul 10, 2025EXHIBITPETITIONER

European Patent No. EP3464373 B1

Jul 10, 2025EXHIBITPETITIONER

Decision Revoking EP3464373 B1, mailed April 19, 2023

Jul 10, 2025EXHIBITPETITIONER

Notices of Opposition to European Patent No. EP3464373 B1

Jul 10, 2025EXHIBITPETITIONER

Request for revocation of European Patent No. EP3464373 B1, mailed April 13, 2023

Jul 10, 2025EXHIBITPETITIONER

Consolidated list of references cited in Oppositions of European Patent No. EP3464373 B1

Jul 10, 2025EXHIBITPETITIONER

Biosimilar-Related IPR Petitions, Biologicshq.com

Jul 10, 2025EXHIBITPETITIONER

Biosimilar-Related IPRs by Reference Product, Biologicshq.com

Jul 10, 2025EXHIBITPETITIONER

Patents Subject to Biosimilar-Related IPRs and Litigations, Biologicshq.com

Jul 10, 2025EXHIBITPETITIONER

Biosimilars Council White Paper, Breaking Through on Biosimilars, Delivering More-Affordable, Innovative Medicines to America's Patients

Jul 10, 2025EXHIBITPETITIONER

Biosimilars in the United States 2023-2027, Iqvia.com

Jul 10, 2025EXHIBITPETITIONER

Biosimilars Forum Applauds the Trump Administration for Drug Pricing Executive Order, Biosimilarsforum.org

Jul 10, 2025EXHIBITPETITIONER

The U.S. Generic & Biosimilar Medicines Savings Report, September 2024

Jul 10, 2025EXHIBITPETITIONER

Petitioner's Opposition to Patent Owner's Discretionary Denial Brief

Jul 10, 2025PAPERPETITIONER

PATENT OWNER’S REQUEST FOR DISCRETIONARY DENIAL

Jun 10, 2025PAPERPATENT OWNER

U.S. Patent No. 9,856,320

Jun 10, 2025EXHIBITPATENT OWNER

Press Release, Bristol-Myers Squibb, FDA Approves Yervoy™ (ipilimumab) for the Treatment of Patients with Newly Diagnosed or Previously-Treated Unresectable or Metastatic Melanoma, the Deadliest Form of Skin Cancer (Mar. 25, 2011)

Jun 10, 2025EXHIBITPATENT OWNER

Press Release, Bristol-Myers Squibb, Bristol-Myers Squibb Receives Accelerated Approval of Opdivo (nivolumab) from the U.S. Food and Drug Administration (Dec. 22, 2014)

Jun 10, 2025EXHIBITPATENT OWNER

YERVOY, FDA Approved label and prescribing information, Rev. 5/2025

Jun 10, 2025EXHIBITPATENT OWNER

OPDIVO, FDA Approved label and prescribing information, Rev. 5/2025

Jun 10, 2025EXHIBITPATENT OWNER

Amgen Pipeline

Jun 10, 2025EXHIBITPATENT OWNER

NCT05907122, “A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma” (Last Update Posted Nov. 27, 2024)

Jun 10, 2025EXHIBITPATENT OWNER

Press Release, Amgen, Amgen Reports First Quarter 2025 Financial Results (May 1, 2025)

Jun 10, 2025EXHIBITPATENT OWNER

Press Release, Amgen, Amgen Reports Fourth Quarter and Full Year 2024 Financial Results (Feb. 4, 2025)

Jun 10, 2025EXHIBITPATENT OWNER

Amgen Biosimilars

Jun 10, 2025EXHIBITPATENT OWNER

Notice filing date accorded to petition

Apr 10, 2025PAPERBOARD

Notice: Mandatory Notice

Mar 21, 2025PAPERPATENT OWNER

Notice: Power of Attorney

Mar 21, 2025PAPERPATENT OWNER

U.S. Patent No. 11,332,529 ("'529 Patent")

Feb 28, 2025EXHIBITPETITIONER

Prosecution History of U.S. Patent No. 11,332,529 - Part 1 of 6

Feb 28, 2025EXHIBITPETITIONER

Prosecution History of U.S. Patent No. 11,332,529 - Part 2 of 6

Feb 28, 2025EXHIBITPETITIONER

Prosecution History of U.S. Patent No. 11,332,529 - Part 3 of 6

Feb 28, 2025EXHIBITPETITIONER

Prosecution History of U.S. Patent No. 11,332,529 - Part 4 of 6

Feb 28, 2025EXHIBITPETITIONER

Prosecution History of U.S. Patent No. 11,332,529 - Part 5 of 6

Feb 28, 2025EXHIBITPETITIONER

Prosecution History of U.S. Patent No. 11,332,529 - Part 6 of 6

Feb 28, 2025EXHIBITPETITIONER

Curriculum Vitae of Dr. Arta M. Monjazeb

Feb 28, 2025EXHIBITPETITIONER

NCT02060188 Version 1, ClinicalTrials.gov ("NCT-188")

Feb 28, 2025EXHIBITPETITIONER

Zhang et al., World J Gastrointest Oncol. 2013 Feb 15; 5(2):12-9. ("Zhang")

Feb 28, 2025EXHIBITPETITIONER

NCT01968109 Version 1, ClinicalTrials.gov ("NCT-109")

Feb 28, 2025EXHIBITPETITIONER

Le et al., N Engl J Med. 2015 Jun 25;372(26):2509-20. ("Le")

Feb 28, 2025EXHIBITPETITIONER

Hammers et al., J Clin Oncol., 33:15_suppl, May 20, 2015 ("Hammers")

Feb 28, 2025EXHIBITPETITIONER

Xiao et al., Cancer Discov. 2015 Jan; 5(1):16-8. ("Xiao")

Feb 28, 2025EXHIBITPETITIONER

Larkin et al., N Engl J Med. 2015 Jul 2; 373(1):23-34. ("Larkin")

Feb 28, 2025EXHIBITPETITIONER

Curran et al., Proc Natl Acad Sci USA. 2010 Mar 2;107(9):4275-80 (“Curran")

Feb 28, 2025EXHIBITPETITIONER

Wolchok et al., N Engl J Med. 2013 Jun 2; 369(2):122-33.

Feb 28, 2025EXHIBITPETITIONER

Llosa et al., Cancer Discov. 2015 Jan; 5(1):43-51. ("Llosa")

Feb 28, 2025EXHIBITPETITIONER

National Cancer Institute, Dictionary of Cancer Terms "Monotherapy"

Feb 28, 2025EXHIBITPETITIONER

Declaration of Prescott Lassman

Feb 28, 2025EXHIBITPETITIONER

Curriculum Vitae of Prescott Lassman

Feb 28, 2025EXHIBITPETITIONER

ClinicalTrials.gov, Glossary of Common Site Terms

Feb 28, 2025EXHIBITPETITIONER

Affidavit of Nathaniel E. Frank-White Re: EX1008 & EX1011

Feb 28, 2025EXHIBITPETITIONER

Raedler et al., Am Health Drug Benefits. 2015 Mar; 8(Spec Feature):180-3.

Feb 28, 2025EXHIBITPETITIONER

Lipson et al., Clin Cancer Res. 2011 Nov 15;17(22):6958-62. (“Lipson-2011”)

Feb 28, 2025EXHIBITPETITIONER

Merriam-Webster Collegiate Dictionary, "Colorectal"

Feb 28, 2025EXHIBITPETITIONER

National Cancer Institute, Dictionary of Cancer Terms, "overall survival"

Feb 28, 2025EXHIBITPETITIONER

Pawlik et al., Dis Markers. 2004; 20(4-5):199-206 ("Pawlik")

Feb 28, 2025EXHIBITPETITIONER

de'Angelis et al., Acta Biomed. 2018 Dec 17; 89(9-S):97-101. ("de'Angelis")

Feb 28, 2025EXHIBITPETITIONER

Lindor et al., J Clin Oncol. 2002 Feb 15; 20(4):1043-8. ("Lindor")

Feb 28, 2025EXHIBITPETITIONER

Boland et al., Cancer Res. 1998 Nov 15; 58(22):5248-57. ("Boland")

Feb 28, 2025EXHIBITPETITIONER

Smyrk et al., Cancer. 2001 Jun 15; 91(12):2417-22. ("Smyrk")

Feb 28, 2025EXHIBITPETITIONER

Mathijssen et al., Oncologist. 2007 Aug; 12(8):913-23. ("Mathijssen")

Feb 28, 2025EXHIBITPETITIONER

Wang et al., J Clin Pharmacol. 2009 Sep; 49(9):1012-24. ("Wang")

Feb 28, 2025EXHIBITPETITIONER

Postow et al., N Engl J Med. 2015 May 21; 372(21):2006-17. ("Postow")

Feb 28, 2025EXHIBITPETITIONER

Le et al., Supplementary Appendix 1. N Engl J Med. 2015 Jun 25; 372(26)

Feb 28, 2025EXHIBITPETITIONER

van Eeghen et al., J Gastrointest Oncol. 2015 Dec; 6(6):605-12.

Feb 28, 2025EXHIBITPETITIONER

Merriam-Webster Medical Dictionary, "monotherapy"

Feb 28, 2025EXHIBITPETITIONER

Lipson et al., Clin Cancer Res. 2013 Jan 15;19(2):462-8. ("Lipson-2013")

Feb 28, 2025EXHIBITPETITIONER

Pernot et al., . World J Gastroenterol. 2014 Apr 14; 20(14):3738-50.

Feb 28, 2025EXHIBITPETITIONER

de la Chapelle et al., J Clin Oncol. 2010 Jul 10; 28(20):3380–3387.

Feb 28, 2025EXHIBITPETITIONER

Le et al., Protocol. N Engl J Med. 2015 Jun 25;372(26):2509-20.

Feb 28, 2025EXHIBITPETITIONER

Feng et al., Br J Clin Pharmacol. 2014 Jan 17; 78(1):106-17. ("Feng")

Feb 28, 2025EXHIBITPETITIONER

U.S. Patent Application Publication No. 2017/0158776 A1

Feb 28, 2025EXHIBITPETITIONER

U.S. Patent No. 8,008,449

Feb 28, 2025EXHIBITPETITIONER

U.S. Patent No. 8,900,587

Feb 28, 2025EXHIBITPETITIONER

U.S. Patent No. 6,984,720

Feb 28, 2025EXHIBITPETITIONER

Kroemer et al., OncoImmunology. 2015 Jun 5; 4(7):e1058597. (“Kroemer”)

Feb 28, 2025EXHIBITPETITIONER

Mansh, Yale J Biol Med. 2011 Dec; 84(4):381–389. ("Mansh")

Feb 28, 2025EXHIBITPETITIONER

Topalian et al., N Engl J Med. 2012 Jun 28; 366(26):2443-54. ("Topalian")

Feb 28, 2025EXHIBITPETITIONER

Brahmer et al., J Clin Oncology. 2010 Jul 1; 28(19):3167–3175. ("Brahmer")

Feb 28, 2025EXHIBITPETITIONER

National Cancer Institute, "nivolumab"

Feb 28, 2025EXHIBITPETITIONER

Antonia et al., J Clin Oncology. 2015 May 20; 33(15S)

Feb 28, 2025EXHIBITPETITIONER

Duraiswamy et al., Cancer Res. 2013 Jun 15; 73(12):3591-603. ("Duraiswamy")

Feb 28, 2025EXHIBITPETITIONER

Callahan et al., J Leukoc Biol. 2013 Jul; 94(1): 41–53. ("Callahan")

Feb 28, 2025EXHIBITPETITIONER

Bai et al., Clin Pharmacokinet. 2012 Feb 1; 51(2):119-35. ("Bai")

Feb 28, 2025EXHIBITPETITIONER

Monjazeb et al., Clin Cancer Res. 2021 May 1; 27(9):2470–2480. ("Monjazeb")

Feb 28, 2025EXHIBITPETITIONER

Declaration of Sylvia D. Hall-Ellis, Ph.D.

Feb 28, 2025EXHIBITPETITIONER

Affidavit of Nathaniel E. Frank-White (Internet Archive)

Feb 28, 2025EXHIBITPETITIONER

ClinicalTrials.gov, Clinical Trial Reporting Requirements

Feb 28, 2025EXHIBITPETITIONER

Press Release: National Institutes of Health Launches "ClinicalTrials.gov"

Feb 28, 2025EXHIBITPETITIONER

Zarin et al., Chest. 2009 Jul; 136(1):295–303.

Feb 28, 2025EXHIBITPETITIONER

ClinicalTrials.gov, How to Edit Your Study Record,

Feb 28, 2025EXHIBITPETITIONER

National Center for Biotechnology Information, About ClinicalTrials.gov

Feb 28, 2025EXHIBITPETITIONER

ClinicalTrials.gov, Trends and Charts on Registered Studies

Feb 28, 2025EXHIBITPETITIONER

Barbee et al., Annals of Pharmacotherapy. 2015, 49(8):907–937. ("Barbee")

Feb 28, 2025EXHIBITPETITIONER

Power of Attorney

Feb 28, 2025PAPERPETITIONER

Declaration of Dr. Arta M. Monjazeb

Feb 28, 2025EXHIBITPETITIONER

Petition for Inter Partes Review

Feb 28, 2025PAPERPETITIONER