Celltrion, Inc. et al. vs Regeneron Pharmaceuticals, Inc.

Other: Fed Circuit mandate

Final Written Decision: original

Petitioner's Updated Power of Attorney

Petitioner's Updated Mandatory Notice

Institution Decision: Joined

Ex. 3001

Notice : Power of Attorney

Notice : Mandatory Notice

Notice: NOTICE OF FILING DATE ACCORDED TO PETITION AND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE

U.S. Patent No. 10,888,601 B2

Expert Declaration of Dr. Thomas A. Albini, ISO IPR of USP 10,888,601

Expert Declaration of Mary Gerritsen, Ph.D. ISO IPR of USP 10,888,601

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Quan Dong Nguyen et al. (2009)

James A Dixon et al. (2009)

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U.S. Patent No. 7,396,664 B2

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Press Release, Regeneron (May 8, 2008)

NCT00509795, ClinicalTrials.gov (Apr. 28, 2009)

NCT00637377, ClinicalTrials.gov (Mar. 17, 2008)

IPR2021-00881 Ex.1109, Diana V. Do Deposition Transcript (April 21, 2022)

Jeffrey S. Heier et al. (2012)

IPR2021-00881 Ex.2051, Expert Declaration of Dr. Diana V. Do, M.D.

Jeffrey S. Heier, Intravitreal VEGF Trap for AMD (2009)

Regeneron Pharm., Inc., Quarterly Report (Form 10-Q) (Sept. 30, 2009)

IPR2021-00881 Ex.1110, David M. Brown Deposition Transcript -April 26, 2022

File History for U.S. Pat. No. 7,070,959, 12/22/2011 Patent Term Extension

File History of U.S. Pat. No. 7,374,758 12/22/2011 Patent Term Extension

Michael Engelbert et al. (2010)

John S. Rudge et al. (2007)

Richard F. Spaide et al. (2009)

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Candelaria Gomez-Manzano et al. (2008)

P Mitchell et al., (2009)

Polly A. Quiram & Yahui Song (2009)

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Anne E. Fung et al. (2007)

Geeta A. Lalwani et al

Hamish M. Fraser et al. (2008)

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Curriculum Vitae of Dr. Thomas Albini

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Heinrich Heimann (2007)

Press Release, Regeneron (February 26, 2009)

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David M. Brown & Carl D. Regillo (2007)

U.S. DEP’T HEALTH & HUMAN SERVS., NIH, NAT’L EYE INST. (Sept. 2015)

Napoleone Ferrara & Kari Alitalo (1999)

Napoleone Ferrara & Robert S. Kerbel (2005)

Ziad F. Bashshur et al. (2006)

LUCENTIS® Prescribing Information (2006)

L. Spielberg & A. Leys (2009)

CENTER FOR DRUG EVALUATION & RESEARCH, BLA No.125-387, Eylea Medical Review

Pearse A. Keane et al. (2009)

J.S. Rudge et al. (2005)

Press Release, Regeneron (March 27, 2007)

Press Release, Regeneron (August 2, 2007)

Retina Society, VEGF Trap-Eye in Wet AMD CLEAR-IT 2 (September 28, 2008)

Press Release, Regeneron (September 28, 2008)

Rama D. Jager (2004)

Philip J. Rosenfeld et al. (2006)

Erik Christensen (2007)

Jorma B. Mueller & Christopher M. McStay (2008)

Curriculum Vitae of Dr. Mary Gerritsen

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File History of European Patent No. 2 663 325

BMJ Publishing Group Ltd., Online First, BJO ONLINE, (Feb. 11, 2009),

BMJ Publishing Group Ltd., Review: Ranibizumab (Lucentis) (Dec, 2020)

European Patent No. 3 222 285

File History of European Patent No. 3 222 285

Press Release, Regeneron (September 14, 2009)

ClinicalTrials.gov, What Is ClinicalTrials.gov?, U.S. NAT’L LIBRARY MED.

Affidavit of Duncan Hall (Internet Archive Records Request Processor)

U.S. Patent No. 9,254,338

Janice M. Reichert (2011)

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Thomas A. Ciulla & Philip J. Rosenfeld (2009)

Zhang Ni & Peng Hui (2009)

Marco A. Zarbin & Philip J. Rosenfeld (2010)

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Carl W. Schneider, Nits, Grits, and Soft Information in SEC Filings (1972)

Justin Kuepper (Jan. 13. 2021)

Kristina Zucchi, EDGAR: January 31, 2014

Adam Hayes, SEC Filings (January 18, 2021)

Kirk R. Wilhelmus (1988)

Christopher Wirbelauer (2006)

IPR2021-00881 Ex. 2055, Napoleone Ferrara et al

IPR2021-00881 Ex.2050, Expert Declaration of David M. Brown, M.D.

IPR2021-00881 Ex.2098, CDER, Statistical Review for Application No. 125387

Amino acid sequence alignment of SEQ ID NO:2 of the ’681 and ’601 patents

Quan Dong Nguyen et al. (2006)

Press Release, Regeneron (August 19, 2008)

IPR2021-00881 Ex.2103, Ongoing Treatment for Patients with Neovascular AMD

John S. Rudge et al. (2008)

Amino acid sequence alignment of SEQ ID NO:2 of the ’681 and ’601 patents

Nucleotide sequence alignment of SEQ ID NO:1 of the ’681 and ’601

ClinicalTrials.gov, 1997: Congress Passes Law (FDAMA) (Oct. 2020)

Affidavit of Duncan Hill (Internet Archive Records Request Processor)

File History of U.S. Patent No. 10,130,681 B2

Part 1 - File History of U. S. Patent No. 10,888,601

Part 2 - File History of U. S. Patent No. 10,888,601

Part 3 - File History of U. S. Patent No. 10,888,601

Part 4 - File History of U. S. Patent No. 10,888,601

Part 5 - File History of U. S. Patent No. 10,888,601

Notice : Power of Attorney

Petition : as filed

Motion : Joinder