UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`SAMSUNG BIOEPIS CO., LTD.
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.
`Patent Owner.
`
`Patent No. 11,253,572
`
`_______________
`
`Inter Partes Review No. IPR2023-00884
`____________________________________________________________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`SAMSUNG BIOEPIS CO., LTD.
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.
`Patent Owner.
`
`Patent No. 11,253,572
`
`_______________
`
`Inter Partes Review No. IPR2023-00884
`____________________________________________________________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`IPR2023-00884
`
`Updated Exhibit List for Inter Partes Review of U.S. Patent No. 11,253,572
`
`Exhibit No.
`
`Exhibit Description
`
`2001
`
`2002
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`Expert Declaration of Richard Manning, Ph.D., Mylan Pharms.
`Inc. v. Regeneron Pharms., Inc., IPR2021-00881, Ex. No. 2052
`(Feb. 11, 2022)
`EYLEA® Label (rev. Oct. 2014)
`Trial Transcript (unsealed portions), Regeneron Pharms., Inc. v.
`Mylan Pharms. Inc., No. 1:22-cv-00061-TSK-JPM (N.D.W. Va.)
`Press Release, Positive Interim Phase 2 Data Reported for VEGF
`Trap-Eye in Age-Related Macular Degeneration, Regeneron
`Pharmaceuticals, Inc. (Mar. 27, 2007)
`Email from George Yancopoulos to Murray Goldberg re Top Line
`sum for PR (Mar. 22, 2007)
`Interim Analysis of Phase 2 Study of VEGF Trap in AMD patients
`(Mar. 22, 2007) (Attachment to Ex.2005)
`George D. Yancopoulos, VEGF Trap : Scientific Background,
`BSP / REGN Kick-Off (Feb. 16, 2007)
`Email from Kathleen Lawrence re Decisions & Actions: AMD
`Ph3 Program Mtg – 4/2/07 (Apr. 2, 2007)
`Email from George Yancopoulos to Darlene Jody re Summary of
`issues for call: AMD P3 Planning with enclosed outline attached
`(Apr. 4, 2007)
`Email from Robert Terifay to George Yancopoulos re VGTeye
`VIEW 430 presentation (Nov. 19, 2010)
`Vascular Endothelial Growth Factor (VEGF) Trap-Eye:
`Investigation of Efficacy and Safety in Wet Age-Related Macular
`Degeneration (AMD) - VIEW 1 and VIEW 2 – 1-Year Results
`(Attachment to Ex.2010)
`Regeneron Pharmaceuticals, Phase 1 Study of VEFT Trap in
`Patients With Diabetic Macular Edema,
`https://clinicaltrials.gov/study/NCT00320814 (last updated Jun.
`10, 2011)
`Regeneron, Clinical Study Concept - Ophthalmology-Diabetic
`Macular Edema-Phase 2-IVT-VGFT-OD-0706 (updated May 19,
`2008)
`Diana V. Do et al., One-Year Outcomes of the DA VINCI Study of
`VEGF Trap-Eye in Eyes with Diabetic Macular Edema, 119
`OPHTHALMOLOGY 1658-1665 (Aug. 2012).
`
`i
`
`
`
`IPR2023-00884
`
`Exhibit No.
`
`Exhibit Description
`
`2015
`
`2016
`
`2017
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`DA VINCI – DME And VEGF Trap-Eye: Investigation of Clinical
`Impact: One Year Data (Dec. 8, 2010) (attachment to Ex.2024)
`Regeneron Pharmaceuticals, DME And VEGF Trap-Eye
`[Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)]
`INvestigation of Clinical Impact (DA VINCI),
`https://clinicaltrials.gov/study/NCT00789477 (last updated Sep. 9,
`2014)
`Email from Caroline Saxton re Data Review (Feb. 1, 2010)
`Regeneron Pharmaceuticals, Inc., VGFT-OD-0706 Week 24
`Topline Results (Feb. 1, 2010) (attachment to Ex.2017)
`DRAFT – DA VINCI – 6-Month Primary Endpoint (Feb. 1, 2010)
`(attachment to Ex.2017)
`Regeneron Pharmaceuticals, Inc., VEGF Trap-Eye Shows Positive
`Results in a Phase 2 Study in Patients With Diabetic Macular
`Edema (Feb. 18, 2010)
`Email from Alyson Berliner to Dave Brown re ARVO late
`breakers (Mar. 1, 2010)
`DA VINCI: DME And VEGF Trap-Eye: Investigation of Clinical
`Impact: Phase 2 study in patients with Diabetic Macular Edema
`(DME) (Mar. 1, 2010) (Attachment to Ex.2021)
`Email from Dave Brown to Alyson Berliner and James Major re
`ARVO abstract (Mar. 3, 2010)
`Email from Caroline Saxton re Slides and tables – DaVinci (Dec.
`8, 2010)
`U.S. Provisional Patent Application No. 61/434,836 (Jan. 21,
`2011)
`Mylan Pharmaceuticals Inc.’s Answer, Defenses, and
`Counterclaims to Plaintiff's Complaint, Regeneron Pharms., Inc. v.
`Mylan Pharms. Inc., No. 1:22-cv-00061-TSK-JPM (N.D.W. Va.),
`ECF No. 47 (filed Aug. 25, 2022)
`Stipulation and Order Joining Biocon Biologics Inc. as Defendant,
`Regeneron Pharms., Inc. v. Mylan Pharms. Inc., No. 1:22-cv-
`00061-TSK-JPM (N.D.W. Va.), ECF No. 523 (filed Jun. 5, 2023)
`Complaint for Patent Infringement, Regeneron Pharms., Inc. v.
`Mylan Pharms. Inc., No. 1:22-cv-00061-TSK-JPM (N.D.W. Va.),
`ECF No. 1 (filed Aug. 2, 2022)
`
`ii
`
`
`
`IPR2023-00884
`
`Exhibit No.
`
`Exhibit Description
`
`2029
`
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`
`2042
`
`Order on Claim Construction, Regeneron Pharms., Inc. v. Mylan
`Pharms. Inc., No. 1:22-cv-00061-TSK-JPM (N.D.W. Va.), ECF
`No. 427 (filed Apr. 19, 2023)
`Scheduling Order, Regeneron Pharms., Inc. v. Mylan Pharms.
`Inc., No. 1:22-cv-00061-TSK-JPM (N.D.W. Va.), ECF No. 87
`(filed Oct. 25, 2022)
`Regeneron's Stipulation Regarding Summary Judgment and Case
`Narrowing, Regeneron Pharms., Inc. v. Mylan Pharms. Inc., No.
`1:22-cv-00061-TSK-JPM (N.D.W. Va.), ECF No. 433 (filed Apr.
`27, 2023)
`Defendant's Opening Post Trial Brief - Issues Where Defendants
`Bear the Burden of Proof, Regeneron Pharms., Inc. v. Mylan
`Pharms. Inc., No. 1:22-cv-00061-TSK-JPM (N.D.W. Va.), ECF
`No. 576 (filed July 7, 2023)
`Order Setting Briefing Schedule, Regeneron Pharms., Inc. v.
`Mylan Pharms. Inc., No. 1:22-cv-00061-TSK-JPM (N.D.W. Va.),
`ECF No. 514 (filed May 30, 2023)
`Transcript of the Status Conference held on Sept. 28, 2022,
`Regeneron Pharms., Inc. v. Mylan Pharms. Inc., No. 1:22-cv-
`00061-TSK-JPM (N.D.W. Va.), ECF No. 90 (filed Nov. 2, 2022)
`Email from George Yancopoulos re DME Phase 2 – ALL
`TABLES (Feb. 2, 2010)
`DME Target Product Profile - VEGF Trap-Eye (Sept. 26, 2007)
`Clinical Development & Regulatory Affairs Weekly Update (Oct.
`29, 2010)
`Clinical Development & Regulatory Affairs Weekly Update (Dec.
`3, 2010)
`Email from George Yancopoulos re DME PLANS & FDA
`meeting pre-discussion (Jan. 9, 2008)
`MEMO re Guidance From Bayer/ REGN Sr. Management
`Regarding Additional Indications in Ophthalmology from George
`Yancopoulos to Bayer/REGN Joint Development Group (Mar. 28,
`2008)
`Action Items by GD Yancopoulos - Bayer/REGN JSC (Feb. 15,
`2008)
`Email from Yuhwen Soo to George Yancopoulos re Can you send
`me that slide you made combining the VA curves for View1 &
`View2 (Nov. 20, 2010)
`
`iii
`
`
`
`IPR2023-00884
`
`Exhibit No.
`
`Exhibit Description
`
`2043
`
`2044
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`
`2051
`
`2052
`
`2053
`2054
`
`Vascular Endothelial Growth Factor (VEGF): Investigation of
`Efficacy and Safety in Wet Age-Related Macular Degeneration
`(AMD)—VIEW1 + VIEW 2: 1-Year Results (Nov. 20, 2010)
`(Attachment to Ex.2042)
`Email from Michael Aberman to George Yancopoulos and
`Leonard Schleifer re Press Release (Nov. 19, 2010)
`Regeneron, Bayer and Regeneron Report Positive Top-Line
`Results of Two Phase 3 Studies with VEGF Trap-Eye in Wet Age-
`related Macular Degeneration (Nov. 19, 2010) (Attachment to
`Ex.2044)
`U.S. Food & Drug Administration, 22 Case Studies Where Phase
`2 and Phase 3 Trials Had Divergent Results (Jan. 2017)
`VEGF Trap-Eye in Wet AMD - CLEAR-IT 2: Summary of One-
`Year Key Results, Presented at 2008 Retina Society Meeting,
`Scottsdale, Arizona (Sep. 28, 2008)
`Regeneron Pharmaceuticals, Inc., A Double-Masked, Randomized,
`Controlled Study of the Safety, Tolerability and Biological Effect
`of Repeated Intravitreal Administration of VEGF Trap-Eye in
`Patients with Diabetic Macular Edema (DME) (Issued Jan. 28,
`2009)
`Appendix to Heier et al., Intravitreal Aflibercept (VEGF Trap-
`Eye) in Wet Age-Related Macular Degeneration, 119
`OPHTHALMOLOGY 2537 (2012)
`Retinal Physician Symposium Covers Broad Range of Topics,
`Retinal Physician (Sept. 1, 2006),
`https://www.retinalphysician.com/issues/2006/september2006/reti
`nal-physician-symposium-covers-broad-range-of
`Prema Abraham et al., Randomized, Double-Masked,
`ShamControlled Trial of Ranibizumab for Neovascular Age-
`Related Macular Degeneration: PIER Study Year 2, 150 AM. J.
`OPHTHALMOLOGY 315 (2010)
`FDA, Step 3: Clinical Research,
`https://www.fda.gov/patients/drug-development-process/step-3-
`clinical-research (last accessed Aug. 23, 2023)
`Prosecution History of U.S. Patent App. No. 16/159,282 B2
`Anant Pai et al., Current concepts in intravitreal drug therapy for
`diabetic retinopathy, 24 SAUDI J. OPHTHALMOLOGY 143 (June 30,
`2010)
`
`iv
`
`
`
`IPR2023-00884
`
`Exhibit No.
`
`Exhibit Description
`
`2055
`
`2056
`
`2057
`
`2058
`
`2059
`2060
`[NEW]
`2061
`[NEW]
`
`David M. Brown et al., Long-term Outcomes of Ranibizumab
`Therapy for Diabetic Macular Edema: The 36-Month Results from
`Two phase Ill Trials, 120 OPHTHALMOLOGY 2013 (2013)
`Jean-Francois Korobelnik et al., Intravitreal Aflibercept for
`Diabetic Macular Edema, 121 OPHTHALMOLOGY 2247 (2014)
`Quan Dong Nguyen et al., Ranibizumab for Diabetic Macular
`Edema, Results from 2 Phase Ill Randomized Trials: RISE and
`RIDE, 119 OPHTHALMOLOGY 789 (2012)
`Ursula Schmidt-Erfurth et al., Three-Year Outcomes of
`Individualized Ranibizumab Treatment in Patients with Diabetic
`Macular Edema. 121 OPHTHALMOLOGY 1045 (2014)
`Default Protective Order
`Declaration of Kira A. Davis in Support of Motion for Admission
`Pro Hac Vice (“Davis Decl.”)
`Declaration of Daralyn J. Durie in Support of Motion for
`Admission Pro Hac Vice (“Durie Decl.”)
`
`Date: December 21, 2023
`
`Respectfully Submitted,
`
`By: /Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, California 94105
`Tel: (415) 268-6053
`ABrausa@mofo.com
`
`Counsel for Patent Owner
`
`v
`
`
`
`IPR2023-00884
`
`Certificate of Service (37 C.F.R. § 42.6(e)(4))
`
`I hereby certify that the attached PATENT OWNER’S UPDATED
`
`EXHIBIT LIST was served on the date listed below via email (by agreement) upon
`
`the following counsel of record for Petitioner:
`
`Raymond N. Nimrod (Reg. No. 31,987)
`Matthew A. Traupman (Reg. No. 50,832)
`Landon Andrew Smith (Reg. No. 79,248)
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`raynimrod@quinnemanuel.com
`matthewtraupman@quinnemanuel.com
`landonsmith@quinnemanuel.com
`qe-samsungbioepis@quinnemanuel.com
`
`Dated: December 21, 2023
`
`/Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`
`1
`
`
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