Amgen Inc. et al. vs. Bristol-Myers Squibb Company

Explore the PTAB proceeding IPR2025-00601 filed by Amgen Inc. et al. on 2025-02-28. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Proceeding Overview

Proceeding Number

IPR2025-00601

Filing Date

2025-02-28

Accorded Filing Date

2025-02-28

Institution Decision Date

2025-07-24

Last Modified Date

2025-12-09

Proceeding Type

IPR

Termination Date

2025-07-24

Trial Status

Discretionary Denial

Parties & Counsel

Petitioner

Amgen Inc. et al.

Represented By

McKeown, Scottet al

Patent Owner / Respondent

Bristol-Myers Squibb Company

Represented By

Maslowski, Stevenet al

Tribunal & Venue

Tribunal

Patent Trial and Appeal Board (USPTO)

Technology Center

TC 1600 - Biotechnology & Organic Chemistry

Patent Information

1 Patent Involved

Respondent Application Number 14400667

Respondent Patent Number 9856320

External Links

Espacenet

Google Patents

Respondent Inventor John P. Cogswell et al

Respondent Tech Center TC 1600 - Biotechnology & Organic Chemistry

Address and Attorney/Agent Information

127 Registered Practitioners

Power of Attorney & Correspondence

Firm / Entity Name Sterne, Kessler, Goldstein & Fox P.L.L.C. - BMS

Customer Number 115018

Address 1101 K Street, NW, 10th Floor, Washington, DC, 20005, UNITED STATES

Attorney / Agent Information

Reg #	Name	Phone
28912	Robert Sterne	202-772-8555
29021	Jorge Goldstein	202-371-2600
32705	Elliott Korsen	609-252-4741
32831	Tracy-Gene Durkin	202-371-2600
33876	Donald Featherstone	202-772-8629
33997	Michael Ray	202-772-8569
34395	Robert Millonig	202-371-2600
35239	Michael Lee	703-628-0233
35888	Henry Hadad	609-252-4825
36013	Robert Sokohl	202-371-2600
36351	Karen Markowicz	202-772-8637
36688	Eric Steffe	202-371-8625
38759	John Covert	202-371-2600
39408	Mary Vanatten	609-252-4379
39967	Eldora Ellison	202-772-8508
41306	Timothy Shea Jr	202-371-2600
42289	Donald Banowit	202-371-2600
42591	Paul Golian	609-252-4091
43447	Jason Eisenberg	202-371-2600
43689	Barry Jacobsen	609-252-5080
44757	Jeffrey Helvey	202-772-8675
45871	Mark Rygiel	202-371-2600
45986	Peter Jackman	202-371-2600
47326	Isabelle Clauss	609-252- 6254
47609	Gary Greenblatt	609-252-3850
47756	Gaby Longsworth	202-371-2600
48256	Pamela Mingo	202-371-2600
48451	Gregory Bellomy	650-260-9187
50720	Jon Wright	202-371-2600
53812	Daniel Yonan	202-371-2600
54144	Zhongmin Guo	4089389060
54179	Michelle Holoubek	202-772-8855
54463	Michael Specht	202-371-2600
54891	Hong Liu	609-252-5312
56374	Ross Hicks	202-371-2600
57170	Bing Hai	609-252-4945
57772	Lori Brandes	202-371-2600
57913	Paul Calvo	202-772-8846
58164	Kristina Kelly	202-776-5284
58403	Marsha Gillentine	202-772-8692
58885	Matthew Bodenstein	202-772-8787
59425	Kyle Conklin	202-371-2600
60167	Scott Schaller	202-371-2600
60390	Richard Coller Iii	202-772-8764
60607	Chandrika Vira	202-772-8672
60789	Cynthia Derenzo	+358-10-505-6847
60889	Salvador Bezos	202-772-8533
61205	David Holman	202-371-2600
61327	Jonathan Tuminaro	202-371-2600
61868	Dennies Varughese	202-772-8805
61908	Andrej Barbic	617-526-9427
62732	Deborah Sterling	202-772-8501
63208	Christopher O'Brien	202-772-8680
63285	Joseph Mutschelknaus	202-371-2600
63504	Ralph Powers Iii	202-772-8876
63929	Jaume Canaves	202-371-2600
64228	Graham Phero	202-772-8860
64286	Ashton Delauney	609-252-4560
64515	Daniel Gajewski	202-772-8774
64565	Teofilo Javier Jr.	617-816-0737
64681	Adam Larock	212-218-2507
64920	Julia Vom Wege	609-252-5188
65021	Christian Camarce	202-772-8895
65172	Byron Pickard	202-371-2600
65211	Michael Malek	410-533-1922
65245	Richard Crudo	202-772-8575
65326	Olga Partington	202-772-8626
65367	Jason Fitzsimmons	202-772-8701
65457	Lauren Schleh	703-836-6400
65934	Marian Silberstein	202-470-6455
66568	Branka Bogunovic	202-772-8727
66638	Jeremiah Frueauf	202-772-8506
67254	Ryan Richardson	202-772-8729
67836	Bonnie Nannenga-Combs	202-371-2600
68395	Daniel Block	202-371-2600
68504	Ji Eun Kim	202-371-2600
68658	Richard Bemben	202-371-2600
68887	Amirali Sharifi	202-772-8871
69086	Daniel Bernard	202-371-2600
69105	Nirav Desai	202-371-2600
69199	Tyler Tassone	202-371-2600
69235	Karen Wong-Chan	202-772-8647
70077	Shoshana Marvin	202-772-8850
70291	Christopher Gallo	202-371-2600
70307	Joshua Mccoy	202-772-8869
70524	Dohm Chankong	202-772-8529
70680	Sarah Leesman	202-371-2600
71185	Rebekah Holtz	202-772-8712
71909	Josephine Kim	949-422-1586
72039	Daniel Choo	202-371-2600
72126	Tyler Liu	202-772-8641
72314	Lestin Kenton Jr.	202-772-8594
72488	Yuke Wang	214-284-3876
72567	Todd Hopfinger	202-772-8696
72755	Hojung Cho	202-772-8710
72762	Bryan Hsu	202-772-8912
72981	Trevor O'Neill	202-371-2600
73112	David Haars	202-371-2600
73287	Charles Hammond	202-772-8551
73707	Matthew Smith	202-772-8503
73904	Steven Pappas	202-772-8719
74017	Robert Niemeier	309-678-6806
74290	Ian Soule	202-772-8984
74533	Alexander Covington	202-772-8749
74612	Ivy Clarice Estoesta	202-772-8686
74992	John Higgins	202-783-6040
75069	Tyler Dutton	202-772-8982
75187	Timothy Tang	202-772-8758
75234	Rola Aylo	202-772-8810
75269	Roozbeh Gorgin	202-772-8667
75349	Brian Burke	202-772-8861
76231	Todd Thurheimer	202-772-8863
76928	Hasina Ali	202-772-8978
76989	Lisa Ritchey	202-371-2600
77546	Brian Dudley	216-647-1931
77776	Zhichun Zhang	202-772-8813
78365	Wenhao Xiong	202-772-8615
78508	Louis Panzica Jr.	202-772-8954
78921	Maria Briscione	202-772-8517
79290	Michael Webb	202-772-8834
79587	Kristofer Schroder	859-991-6529
79831	Christian Berrios	317-345-2233
80131	Brittany Internoscia	908-507-3747
80152	Calvin Mendel	202-772-8511
80168	Benjamin Nagasing	202-772-8981
81060	Michael Guzzano	202-772-8646
81318	Pratibha Khanduri	202-772-8509

Proceeding Documents

117

Notice: refund approved NOTICE

2025-12-09 FILING PARTY: BOARD

Download

Petitioner's Request for Refund OTHER

2025-12-05 FILING PARTY: PETITIONER

Download

Order Denying Director Review of Institution Decision REHEARING

2025-10-20 FILING PARTY: BOARD

Download

AUTHORIZED RESPONSE TO DIRECTOR REVIEW REQUEST OTHER

2025-09-03 FILING PARTY: PATENT OWNER

Download

3100

Email, Subject_RE_ IPR2025-00601_ Deposit Account Withdrawal Authorization Exhibit

2025-08-26 FILING PARTY: BOARD

Download

Amgen Inc. et al. vs. Bristol-Myers Squibb Company

Proceeding Overview

Parties & Counsel

Petitioner

Amgen Inc. et al.

Represented By

Patent Owner / Respondent

Bristol-Myers Squibb Company

Represented By

Tribunal & Venue

Patent Information

Address and Attorney/Agent Information

Power of Attorney & Correspondence

Attorney / Agent Information

Proceeding Documents

Notice: refund approved NOTICE

Petitioner's Request for Refund OTHER

Order Denying Director Review of Institution Decision REHEARING

AUTHORIZED RESPONSE TO DIRECTOR REVIEW REQUEST OTHER

Email, Subject_RE_ IPR2025-00601_ Deposit Account Withdrawal Authorization Exhibit

Email, Subject_IPR2025-00601 and -00602 Director Review Requests Exhibit

Request for Director Review - Institution Decision REQUEST

Director Discretionary Decision: Deny RESPONSE

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

"Potential Impact of the Affordable Prescriptions for Patients Act Patent Limit on BPCIA Litigations", Venable LLP Exhibit

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

OPDIVO FDA Approval label and prescribing information, December 2014 Exhibit

U.S. Food and Drug Administration, The Drug Development Process, Step 3: Clinical Research (Content current as of Jan. 4, 2018), available at https://www.fda.gov/patients/drug-development-process/step-3-clinical-research Exhibit

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

Wang, D.D. et al. Fixed Dosing Versus Body Size–Based Dosing of Monoclonal Antibodies in Adult Clinical Trials, J Clin Pharmacol., 2009 Sep; 49(9):1012-24 Exhibit

Keytruda FDA Approval label and prescribing information, June 2025 Exhibit

Patent Owner's Preliminary Response POPR

Opdivo FDA Approval label and prescribing information, May 2025 Exhibit

Declaration of Peter P. Lee, M.D. Exhibit

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

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

NCT01024231, “Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma” (Last Update Posted Mar. 22, 2021), available at https://clinicaltrials.gov/study/NCT01024231 Exhibit

Umscheid, C.A. et al. Key Concepts of Clinical Trials: A Narrative Review, Postgraduate Medicine, 2011 Sep; 123:5, 194-204 Exhibit

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

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

National Institutes of Health, National Cancer Institute, NCI Dictionary of Cancer Terms, Definition of “partial response” available at https://www.cancer.gov/publications/dictionaries/cancer-terms/def/partial-response (last visited July 9, 2025) Exhibit

Biosimilar-Related IPRs by Reference Product, Biologicshq.com Exhibit

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

Biosimilar-Related IPR Petitions, Biologicshq.com Exhibit

NCT00730639, “A Phase 1 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Recurrent Malignancies (MDX1106-03)” (Last Update Posted Dec. 3, 2021), available at https://clinicaltrials.gov/study/NCT00730639 Exhibit

Curriculum Vitae of Peter P. Lee, M.D. Exhibit

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

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

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

European Patent Application No. 17189595.6 - Annex to Communication (Oct. 7, 2019) Exhibit

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

National Institutes of Health, National Cancer Institute, NCI Dictionary of Cancer Terms, Definition of “complete response” available at https://www.cancer.gov/publications/dictionaries/cancer-terms/def/complete-response (last visited July 9, 2025) Exhibit

Press Release, Bristol-Myers Squibb, Bristol-Myers Squibb Completes Acquisition of Medarex, Inc. (Sept. 1, 2009), available at https://news.bms.com/news/details/2009/Bristol-Myers-Squibb-to-Acquire-Medarex/default.aspx Exhibit

U.S. Patent No. 10,441,655 Exhibit

U.S. Patent No. 9,387,247 Exhibit

Brittain, B., Bristol Myers sues AstraZeneca over cancer-treatment patents, Reuters (Mar. 18, 2022) Exhibit

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

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

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

Amgen Pipeline Exhibit

Amgen Biosimilars, available at https://www.amgen.com/science/biosimilars Exhibit

U.S. Patent No. 9,492,540 Exhibit

PATENT OWNER’S REQUEST FOR DISCRETIONARY DENIAL RESPONSE

U.S. Patent No. 8,779,105 Exhibit

U.S. Patent No. 9,492,539 Exhibit

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) Exhibit

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

NCT01024231, “Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma” (Last Update Posted Mar. 22, 2022) Exhibit

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

U.S. Patent No. 8,728,474 Exhibit

U.S. Patent No. 9,084,776 Exhibit

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

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) Exhibit

Sharma, P., et al. Novel cancer immunotherapy agents with survival benefit: recent successes and next steps, 11(11) Nat. Rev. Cancer at 805-812 (2011) Exhibit

Complaint, Bristol-Myers Squibb Co. and E.R. Squibb & Sons, L.L.C., v. AstraZeneca Pharmaceuticals LP and AstraZeneca UK LTD., Civil Action No. 1:22-cv-00346-UNA (D. Del. filed Mar. 17, 2022) Exhibit

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

Notice: Notice filing date accorded NOTICE

Notice: Power of Attorney NOTICE

Notice: Mandatory Notice NOTICE

Parry et al., Mol Cell Biol. 2005 Nov; 25(21):9543-53. Exhibit