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

Patent Owner's Supplemental Pre-Institution Brief

Patent Owner's Updated Exhibit List

Statutory Disclaimer of U.S. Patent No. 11,332,529

Director Discretionary Decision: Refer

OPDIVO FDA Approval label and prescribing information, December 2014

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

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

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

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

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

European Patent No. EP3464373 B1

Decision Revoking EP3464373 B1, mailed April 19, 2023

Notices of Opposition to European Patent No. EP3464373 B1

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

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

Biosimilar-Related IPR Petitions, Biologicshq.com

Biosimilar-Related IPRs by Reference Product, Biologicshq.com

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

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

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

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

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

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

PATENT OWNER’S REQUEST FOR DISCRETIONARY DENIAL

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

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)

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

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

Amgen Pipeline

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

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

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

Amgen Biosimilars

Notice filing date accorded to petition

Notice: Mandatory Notice

Notice: Power of Attorney

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

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

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

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

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

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

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

Curriculum Vitae of Dr. Arta M. Monjazeb

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Curriculum Vitae of Prescott Lassman

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

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

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Power of Attorney

Declaration of Dr. Arta M. Monjazeb

Petition for Inter Partes Review