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

Director Discretionary Decision: Deny

Patent Owner's Preliminary Response

Declaration of Peter P. Lee, M.D.

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

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Summons to Attend Oral Proceedings, European Patent Application No. 16725959.7 mailed on April 28, 2021

Declaration of Withdrawal of European Patent Application No. 16725959.7, mailed on October 1, 2021

European Patent No. EP3288980 B1

Consolidated list of references cited in Opposition of European Patent No. EP3288980 B1

Declaration of Dr. Leonard, submitted in connection with Opposition of European Patent No. EP3288980 B1

Declaration of Dr. Langguth, submitted in connection with Opposition of European Patent No. EP3288980 B1

Grounds for Decision Revoking European Patent No. EP3288980 B1, mailed March 13, 2024

Examination Report mailed on October 8, 2018 in European Patent Application No. 16725959.7

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

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

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

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

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Statement of Grounds for Appeal of Decision Revoking European Patent No. EP3288980 B1, filed July 15, 2024

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

PATENT OWNER’S REQUEST FOR DISCRETIONARY DENIAL

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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)

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Amgen Biosimilars

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Notice filing date accorded to petition

Notice: Mandatory Notice

Notice: Power of Attorney

U.S. Patent No. 10,174,113 ("'113 Patent")

Prosecution History of U.S. Patent No. 10,174,113 - Part 1 of 2

Prosecution History of U.S. Patent No. 10,174,113 - Part 2 of 2

Curriculum Vitae of Dr. Brent Hanks M.D., Ph.D.

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Declaration of Dr. Dhaval Shah

Curriculum Vitae of Dr. Dhaval Shah

Declaration of Prescott Lassman

Curriculum Vitae of Prescott Lassman

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Power of Attorney

Declaration of Dr. Brent Hanks M.D., Ph.D.

Petition for Inter Partes Review