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

Other: Fed Circuit mandate

JUDGMENT Final Written Decision Denying in Part, Granting in Part, and Dismissing in Part Petitioner’s Motion to Exclude Evidence, Denying in Part and Dismissing in Part Patent Owner’s Motion to Exclude Evidence, Determining Challenged Claims 1, 3–11, 13, 14, 16–24, and 26 Unpatentable 35 U.S.C. § 318(a)

Petitioner's Updated Mandatory Notice

Petitioner's Updated Power of Attorney

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. 10,130,681 B2 (“‘681 patent”)

Expert Declaration of Dr. Thomas A. Albini

Expert Declaration of Mary Gerritsen, Ph.D.

Jocelyn Holash et al., VEGF-Trap

Quan Dong Nguyen et al.,

James A Dixon et al.

Adis R&D Profile, Aflibercept: AVE 0005

U.S. Patent No. 7,531,173 B2 (“‘173 patent”)

U.S. Patent No. 7,396,664 B2 (“‘664 patent”)

U.S. Patent No. 7,374,758 B2 (“‘758 patent”)

F Semeraro et al., Aflibercept in Wet AMD: Specific Role and Optimal

Press Release, Regeneron (Apr. 28, 2008)

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)

File History of U.S. Patent No. 10,130,681 B2 (“’681 FH”)

Jeffrey S. Heier et al.

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 (Apr. 26, 2022)

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

File History of U.S. Pat. No. 7,374,758 B2, 12/22/2011 Pat. Term Extension

Michael Engelbert et al., (2010)

John S. Rudge et al., (2007)

Richard F. Spaide et al., (2009)

IPR2021-00881 Ex.2080, Jeffery S. Heier,

Candelaria Gomez-Manzano et al. (2008)

P Mitchell et al., (2009)

Polly A. Quiram & Yahui Song (2009)

Press Release, Bayer AG (May 8, 2008)

U.S. Patent App., Publication No. 2006/0217311 A1 (“Dix”)

Anne E. Fung et al. (2007)

Geeta A. Lalwani et al. (2009)

Hamish M. Fraser et al. (2008)

CENTER FOR DRUG EVALUATION & RESEARCH, BLA No. 125156, Lucentis Med. Review

Curriculum Vitae of Dr. Thomas Albini

U.S. Patent No. 7,378,095 B2

Heinrich Heimann, Intravitreal Injections (2007)

Press Release, Regeneron (Feb. 26, 2009)

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

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

U.S. DEP’T HEALTH & HUMAN SERVS., NIH, NAT’L EYE INST., (Sep. 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 EVAL. & 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 (Aug. 2, 2007)

Retina Society, VEGF Trap-Eye in Wet AMD CLEAR-IT 2 (Sep. 8, 2008)

Press Release, Regeneron, VEGF Trap-Eye Final Phase 2 Results (9.28.2008)

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

European Patent No. 2 663 325 (published as WO 2012/097019 A1)

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 (Sep. 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)

Owen A. Anderson et al. (2010)

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

Zhang Ni & Peng Hui (2009)

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

Corporate Finance Institute, SEC Filings (May 5, 2021)

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

Justin Kuepper, The Best Investment Information Sources (Jan. 13, 2021)

Kristina Zucchi, EDGAR (Jan. 31. 2014)

Adam Hayes, SEC Filings, INVESTOPEDIA (Jan. 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 App. 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 (Aug. 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 patents

Eugene S. Kim et al. (2002)

File History of U.S. Patent No. 9,254,338 B2

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

Monthly Dosing Patents: 7,303,746 ; 7,303,747 ; 7,306,799 & 7,521,049

IPR2021-00881, Ex.2003, Lucentis (ranibizumab injection) Label, revised

Notice : Power of Attorney

Petition : as filed

Motion : Joinder