`
`_________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________________
`
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`_________________________
`
`Case IPR2023-00884
`
`U.S. Patent No. 11,253,572
`_________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 11,253,572
`
`DECLARATION OF DR. EDWARD CHAUM
`
`Samsung Bioepis Exhibit 1002 Page 1
`Biocon Exhibit 1002 Page 1
`
`
`
`V.
`
`F.
`
`TABLE OF CONTENTS
`INTRODUCTION ....................................................................................... 1
`I.
`BACKGROUND AND QUALIFICATIONS .............................................. 2
`II.
`INFORMATION RELIED UPON ............................................................... 5
`III.
`IV. RELEVANT LEGAL STANDARD ............................................................ 6
`A.
`Person of Ordinary Skill in the Art..................................................... 7
`B.
`Claim Construction ............................................................................ 9
`C.
`Presumption of Validity ................................................................... 10
`D.
`Obviousness ..................................................................................... 10
`TECHNOLOGY BACKGROUND............................................................ 14
`A.
`Diabetic Retinopathy (DR) .............................................................. 14
`B.
`Diabetic Macular Edema .................................................................. 15
`C.
`Age-Related Macular Degeneration (AMD) .................................... 15
`D.
`VEGF Trap-Eye/Aflibercept ............................................................ 17
`E.
`Dosing Regimen for Intravitreal Injections of VEGF
`Antagonists ...................................................................................... 20
`Exclusion Criteria Intended to Reduce Risks Associated with
`Intravitreal Injections ....................................................................... 22
`VI. BACKGROUND OF THE ’572 PATENT ................................................. 25
`A.
`General Description ......................................................................... 25
`B.
`Prosecution History.......................................................................... 27
`VII. CHALLENGED CLAIMS ......................................................................... 28
`VIII. CLAIM CONSTRUCTION ....................................................................... 29
`A.
`“A method for treating…” ............................................................... 29
`B.
`“Exclusion Criteria” ......................................................................... 31
`PRIORITY DATE ..................................................................................... 33
`A.
`Applicable Legal Standard ............................................................... 33
`
`IX.
`
`ii
`
`Samsung Bioepis Exhibit 1002 Page 2
`Biocon Exhibit 1002 Page 2
`
`
`
`B.
`
`X.
`
`2.
`
`Claim 25 of the ’572 Patent Has an Earliest Effective Filing
`Date of July 12, 2013 at Best ........................................................... 35
`INVALIDITY UNDER 35 U.S.C. § 103 ................................................... 37
`A.
`Overview of the Prior Art ................................................................ 37
`1.
`September 14, 2009 Press Release ......................................... 37
`2.
`November 22, 2010 Press Release ......................................... 38
`3.
`December 20, 2010 Press Release .......................................... 39
`4.
`Dixon ..................................................................................... 40
`5.
`Hecht ..................................................................................... 41
`6.
`Shams 2006 ........................................................................... 42
`7.
`Elman 2010 ............................................................................ 43
`8.
`CATT and PIER Studies ........................................................ 46
`9.
`Prior Art Regarding Efficacy of Aflibercept .......................... 50
`Analysis ........................................................................................... 52
`1.
`Claims 15 and 24 are Anticipated by Each of the 2009
`Press Release and December 2010 Press Release ................... 52
`Claims 1-5, 8-11, 16-17, and 20-21 (Generic/DME
`Results Claims) Are Anticipated by the December 2010
`Press Release ......................................................................... 55
`Claims 26-30 (AMD Results Claims) Are Anticipated by
`the November 2010 Press Release ......................................... 60
`Claims 1-5, 8-11, and 26-30 (Generic/AMD Results
`Claims) Are Rendered Obvious by Dixon Alone or In
`View of the 2006 Press Release ............................................. 64
`Claims 16-17, and 20-21 (DME Results Claims) Are
`Rendered Obvious by the 2009 Press Release Alone or in
`View of the 2007 ARVO Abstract, Dixon, and/or the
`2010 ARVO Abstract (collectively, “Section X.B.5
`References”) .......................................................................... 72
`
`B.
`
`3.
`
`4.
`
`5.
`
`iii
`
`Samsung Bioepis Exhibit 1002 Page 3
`Biocon Exhibit 1002 Page 3
`
`
`
`6.
`
`7.
`
`Claims 6-7 and 12-13 (Aflibercept Formulation) Are
`Rendered Obvious by Each of Dixon in View of Hecht,
`Dixon in View of the 2006 Press Release and Hecht, and
`the December 2010 Press Release in View of Hecht .............. 76
`Claims 18-19 and 22-23 (Aflibercept Formulation) Are
`Rendered Obvious by Each of the December 2010 Press
`Release in View of Hecht, and the 2009 Press Release in
`View of the Section X.B.5 References and Hecht .................. 78
`Claim 14 (Exclusion Criteria) Is Rendered Obvious by
`Each of Dixon, and the December 2010 Press Release
`Alone or In View of the CATT Study and/or PIER Study ...... 78
`Claim 25 (Five Initial Doses) is Rendered Obvious by the
`2009 Press Release Alone or in View of Shams or Elman
`2010 ....................................................................................... 81
`Claims 1-5, 8-11, and 26-30 (Generic/AMD Results
`Claims) are Anticipated by Dixon Because the “Results
`Limitations” Lack Patentable Weight..................................... 98
`Claims 1-5, 8-11, 16-17, and 20-21 (Generic/DME
`Results Claims) are Anticipated by the 2009 Press
`Release Because the “Results Limitations” Lack
`Patentable Weight .................................................................. 98
`XI. NO SECONDARY CONSIDERATIONS.................................................. 99
`XII. SUPPLEMENTATION ........................................................................... 100
`
`10.
`
`8.
`
`9.
`
`11.
`
`iv
`
`Samsung Bioepis Exhibit 1002 Page 4
`Biocon Exhibit 1002 Page 4
`
`
`
`TABLE OF EXHIBITS
`
`1005
`
`1006
`
`Exhibit Description
`1001
`U.S. Patent No. 11,253,572
`1003
`Edward Chaum Curriculum Vitae
`1004
`Institution Decision in Apotex Inc. v. Regeneron Pharmaceuticals, Inc.,
`IPR2022-01524. (“Apotex ’572 ID”)
`Press Release, “Enrollment Completed in Regeneron and Bayer
`Healthcare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-
`Related Macular Degeneration (Wet AMD) (September 14, 2009),”
`available
`at:
`https://newsroom.regeneron.com/news-releases/news-
`release-details/enrollment-completed-regeneron-and-bayer-healthcare-
`phase-3 (“2009 Press Release”)
`Press Release, “Regeneron and Bayer Report Positive Results for VEGF
`Trap-Eye in Phase 3 Study in Central Retinal Vein Occlusion (CRVO)
`and in Phase 2 Study in Diabetic Macular Edema (DME),” Exhibit 99.1
`to Regeneron 8-K filed on December 20, 2010, available at:
`https://yahoo.brand.edgar-
`online.com/displayfilinginfo.aspx?FilingID=7617341-6436-
`23571&type=sect&TabIndex=2&companyid=5036&ppu=%252fdef%
`E2%80%A6 (“December 2010 Press Release”)
`Press Release, “Bayer and Regeneron Report Positive Top-Line Results
`of Two Phase 3 Studies with VEGF Trap-Eye in Wet Age-related
`Macular Degeneration,” Exhibit 99.1 to Regeneron 8-K filed on
`November 22, 2010,
`available
`at:
`https://yahoo.brand.edgar-
`online.com/displayfilinginfo.aspx?FilingID=7572010-8611-
`26486&type=sect&TabIndex=2&companyid=5036&ppu=%252fdef%
`E2%80%A6 (“November 2010 Press Release”)
`1008 Apotex Petition for
`IPR filed
`in Apotex Inc. v. Regeneron
`Pharmaceuticals, Inc., IPR2022-01524 (Paper 1) (“Apotex Petition”)
`1009 Dixon JA, Oliver SC, Olson JL, Mandava N. VEGF Trap-Eye for the
`treatment of neovascular age-related macular degeneration. Expert Opin
`Investig Drugs. 2009;18(10):1573-1580. (“Dixon”)
`1010 Major JC et al., “DA VINCI: DME and VEGF Trap-Eye: INvestigation
`of Clinical Impact: Phase 2 Study in Patients With Diabetic Macular
`
`1007
`
`-v-
`
`Samsung Bioepis Exhibit 1002 Page 5
`Biocon Exhibit 1002 Page 5
`
`
`
`1011
`
`1012
`
`1013
`
`Exhibit Description
`Edema (DME), ARVO Annual Meeting Abstract (April 2010), Vol. 51,
`Issue
`13,
`available
`at:
`https://iovs.arvojournals.org/article.aspx?articleid=2375028
`(“2010
`ARVO Abstract”)
`Final Written Decision in Mylan Pharmaceuticals Inc. v. Regeneron
`Pharmaceuticals, Inc., IPR2021-00881 (Paper 94) (“’338 FWD”)
`Institution Decision in Mylan Pharmaceuticals Inc. v. Regeneron
`Pharmaceuticals, Inc., IPR2022-01225 (Paper 21) (“’681 ID”)
`Institution Decision in Mylan Pharmaceuticals Inc. v. Regeneron
`Pharmaceuticals, Inc., IPR2022-01226 (Paper 22) (“’601 ID”)
`1014 Certified Prosecution History of U.S. Patent No. 11,253,572 (“’572
`patent PH”)
`1015 Adis R&D Profile, Aflibercept: AVE 0005, AVE 005, AVE0005, VEGF
`Trap - Regeneron, VEGF Trap (R1R2), VEGF Trap-Eye. Drugs R D.
`2008;9(4):261-269. (“Adis”)
`1016 Hecht, “Opthalmic Preparations,” Remington: The Science and Practice
`of Pharmacy, Volume II, 19th edition, Chapter 89 (1995). (“Hecht”)
`1017 WO 2006/047325 Al (“Shams”)
`1018
`Elman MJ, et al., Randomized trial evaluating ranibizumab plus prompt
`or deferred laser or triamcinolone plus prompt laser for diabetic macular
`edema. Ophthalmology. 2010 Jun;117(6):1064-1077.e35. (“Elman
`2010”)
`Elman MJ, et al., Randomized trial evaluating ranibizumab plus prompt
`or deferred laser or triamcinolone plus prompt laser for diabetic macular
`edema. Ophthalmology. 2010 Jun;117(6):1064-1077.e35, published
`April 28 2010, available at https://www.aaojournal.org/article/S0161-
`6420(10)00243-5/fulltext (“Elman AAO Website”)
`1020 Authenticating Affidavit and the July 13, 2010 Web Archive of the
`CATT
`Patient
`Eligibility
`Criteria,
`available
`at
`https://web.archive.org/web/20100713035617/http://www.med.upenn.e
`du/cpob/studies/documents/CATTEligibilityCriteria_000.pdf, attached
`as Exhibit B (“CATT Study”).
`
`1019
`
`
`
`vi
`
`Samsung Bioepis Exhibit 1002 Page 6
`Biocon Exhibit 1002 Page 6
`
`
`
`Exhibit Description
`1021 Regillo CD, Brown DM, Abraham P, et al. Randomized, double-masked,
`sham-controlled trial of ranibizumab for neovascular age-related
`macular degeneration: PIER Study year 1. Am J Ophthalmol.
`2008;145(2):239-248. (“PIER Study”).
`1022 Comparison of Age-related Macular Degeneration Treatments Trials:
`Lucentis-Avastin
`Trial
`(NCT00593450),
`available
`at:
`https://clinicaltrials.gov/ct2/show/NCT00593450 (“NCT-450”)
`1023 Regillo CD, Brown DM, Abraham P, et al. Randomized, double-masked,
`sham-controlled trial of ranibizumab for neovascular age-related
`macular degeneration: PIER Study year 1. Am J Ophthalmol.
`2008;145(2):239-248, published December 3, 2007, available at
`https://www.ajo.com/article/S0002-9394(07)00881-1/fulltext
`(“PIER
`AJO Website”)
`1024 History of Changes for Study: A Study of rhuFab V2 (Ranibizumab) in
`Subjects With Subfoveal Choroidal Neovascularization Secondary to
`Age-Related Macular Degeneration (AMD) (NCT00090623), available
`at:
`https://clinicaltrials.gov/ct2/history/NCT00090623?V_1=View#StudyP
`ageTop. (“NCT-623”)
`at:
`available
`Background,
`1025 ClinicalTrials.gov
`https://clinicaltrials.gov/ct2/about-site/background (“ClinicalTrials.gov
`Background”)
`1026 ClinicalTrials.gov About the Results Database, available at:
`https://clinicaltrials.gov/ct2/about-site/results
`
` (“ClinicalTrials.gov
`About the Results Database”)
`Press Release, “Regeneron Reports Positive Phase 1 Data for the VEGF
`TRAP in Age-Related Macular Degeneration,” Exhibit 99(a) to
`Regeneron
`8-K
`filed
`on May
`2,
`2006,
`available
`at:
`https://yahoo.brand.edgar-
`online.com/displayfilinginfo.aspx?FilingID=4380124-5423-
`15279&type=sect&TabIndex=2&companyid=5036&ppu=%252fdef%
`E2%80%A6
`(“May 2006 Press Release”)
`
`1027
`
`vii
`
`Samsung Bioepis Exhibit 1002 Page 7
`Biocon Exhibit 1002 Page 7
`
`
`
`1029
`
`Exhibit Description
`1028 Nguyen QD et al. A phase I study of intravitreal vascular endothelial
`growth factor trap-eye in patients with neovascular age-related macular
`degeneration. Ophthalmology. 2009 Nov;116(11):2141-8.e1. (“Nguyen
`2009”)
`Press Release, “Bayer and Regeneron Dose First Patient in Second Phase
`3 Study for VEGF Trap-Eye in Wet Age-Related Macular Degeneration”
`published
`on
`May
`8,
`2008,
`available
`at:
`https://investor.regeneron.com/node/10561/pdf
` (“May 2008 Press
`Release”)
`1030 Do DV et al., “Results of a Phase I Study of Intravitreal VEGF Trap in
`Subjects With Diabetic Macular Edema: The CLEAR-IT DME Study,”
`ARVO Annual Meeting Abstract (May 2007), Vol. 48, Issue 3, available
`at: https://iovs.arvojournals.org/article.aspx?articleid=2384099 (“2007
`ARVO Abstract”)
`1031 Do DV et al., The DA VINCI Study: phase 2 primary results of VEGF
`Trap-Eye in patients with diabetic macular edema. Ophthalmology. 2011
`Sep;118(9):1819-26 (published online on May 5, 2011). (“Do 2011”)
`1032 Randolph and Jones, “Surfactant-Protein Interactions,” Rational Design
`of Stable Protein Formulations, edited by Carpenter and Manning, vol.
`13, 2002 (“Randolph”)
`Fraser et al., Journal of Clinical Endocrinology and Metabolism,
`February 2005, 90(2):1114-1122 (“Fraser”)
`Lucentis ® Original Approved Labeling (2006), available at:
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125156s000
`0_Lucentis_Prntlbl.pdf (“Lucentis Label”)
`1035 Holash J, Davis S, Papadopoulos N, et al. VEGF-Trap: a VEGF blocker
`with potent antitumor effects. Proc Natl Acad Sci U S A.
`2002;99(17):11393-11398. (“Holash”)
`1036 Rudge JS, Thurston G, Davis S, et al. VEGF trap as a novel
`antiangiogenic treatment currently in clinical trials for cancer and eye
`diseases, and VelociGene- based discovery of the next generation of
`angiogenesis targets. Cold Spring Harb Symp Quant Biol. 2005;70:411-
`418 (“Rudge 2005”)
`
`1033
`
`1034
`
`viii
`
`Samsung Bioepis Exhibit 1002 Page 8
`Biocon Exhibit 1002 Page 8
`
`
`
`1040
`
`Exhibit Description
`1037 Gomez-Manzano C, Holash J, Fueyo J, et al. VEGF Trap induces
`antiglioma effect at different stages of disease. Neuro Oncol.
`2008;10(6):940-945. (“Gomez-Manzano”)
`1038 Heier JS, et al., Intravitreal aflibercept (VEGF trap-eye) in wet age-
`related macular degeneration. Ophthalmology. 2012;119(12):2537-
`2548. (“Heier 2012”)
`1039 Heier JS, et al., CLEAR-IT 2 Investigators. The 1-year results of
`CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-
`eye dosed as-needed after 12-week fixed dosing. Ophthalmology. 2011
`Jun;118(6):1098-106. (“Heier 2011”)
`Pai A, El Shafei MM, Mohammed OA, Al Hashimi M., Current concepts
`in intravitreal drug therapy for diabetic retinopathy. Saudi J Ophthalmol.
`2010 Oct;24(4):143-9. (“Pai 2010”)
`1041 U.S. Patent App. Pub. US 2007/0190058A1 (“Shams US App. Pub.”)
`1042
`U.S. Patent No. 9,254,338 (“’338 patent”)
`1043 WO 2012/097019A1 (“Yancopoulos PCT Application”)
`1044 U.S. Dep’t Health & Human Servs., Nat’l Inst. Health, Nat’l Eye Inst.,
`“Diabetic Retinopathy: What You Should Know (Sept. 2015),” available
`at:
`https://www.nei.nih.gov/sites/default/files/health-
`pdfs/Diabetic_Retinopathy_What_You_Should_Know.pdf (“NIH DR”)
`1045 U.S. Dep’t Health & Human Servs., Nat’l Inst. Health, Nat’l Eye Inst.,
`“Age-Related Macular Degeneration: What You Should Know (Sept.
`2015),”
`available
`at:
`https://www.nei.nih.gov/sites/default/files/healthpdfs/WYSK_AMD_E
`nglish_Sept2015_PRINT.pdf (“NIH AMD”)
`1046 Halpern MT, Schmier JK, Covert D, Venkataraman K. Resource
`utilization and costs of age-related macular degeneration. Health Care
`Financ Rev. 2006;27(3):37-47. (“Halpern 2006”)
`1047 Rudge JS, Holash J, Hylton D, et al. VEGF Trap complex formation
`measures production rates of VEGF, providing a biomarker for
`predicting efficacious angiogenic blockade. Proc Natl Acad Sci U S A.
`2007;104(47):18363-18370. (“Rudge 2007”)
`
`ix
`
`Samsung Bioepis Exhibit 1002 Page 9
`Biocon Exhibit 1002 Page 9
`
`
`
`Exhibit Description
`1048
`Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment
`regimens for administration of anti-vascular endothelial growth factor
`agents for neovascular age-related macular degeneration. Cochrane
`Database Syst Rev. 2020;5(5):CD012208. (“Li 2020”)
`1049 Brown DM, Michels M, Kaiser PK, et al. Ranibizumab versus
`verteporfin photodynamic therapy for neovascular age-related macular
`degeneration: Two-year results of the ANCHOR study. Ophthalmology.
`2009;116(1):57-65.e5. (“Brown 2009”)
`1050 Martin DF, Maguire MG, Fine SL, Ying GS, Jaffe GJ, Grunwald JE, et
`al, Comparison of Age-Related Macular Degeneration Treatments Trial
`(CATT) Research Group. Ranibizumab and bevacizumab for treatment
`of neovascular age-related macular degeneration: two-year results.
`Ophthalmology 2012; 119(7):1388-98 (“Martin”)
`1051 Chakravarthy U, Harding SP, Rogers CA, Downes SM, Lotery AJ,
`Wordsworth S, et al, Inhibition of VEGF in Age-related choroidal
`Neovascularization (IVAN) Study Investigators. Ranibizumab versus
`bevacizumab to treat neovascular age-related macular degeneration:
`one-year findings from the IVAN randomized trial. Ophthalmology
`2012; 119(7):1399-411 (“Chakravarthy 2012”)
`1052 Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY,
`et al. Ranibizumab for neovascular age-related macular degeneration.
`New England Journal of Medicine 2006; 355(14):1419-31 (“Rosenfeld
`2006”)
`1053 Heimann, H. (2007). Chapter 5 Intravitreal Injections: Techniques and
`Sequelae. In: Holz, F.G., Spaide, R.F. (eds) Medical Retina. Essentials
`in Ophthalmology. Springer, Berlin, Heidelberg. (“Heimann 2007”)
`Jager RD, Aiello LP, Patel SC, Cunningham ET Jr. Risks of intravitreous
`injection: a comprehensive review. Retina. 2004;24(5):676-698. (“Jager
`2004”)
`1055 Certified Prosecution History of U.S. Patent No. 10,130,681 B2 (“’681
`patent PH”)
`Pilot Study of Intravitreal Injection of Ranibizumab for Macular
`Telangiectasia With Neovascularization (NCT00685854) (May 24,
`2008),
`available
`at:
`
`1056
`
`1054
`
`x
`
`Samsung Bioepis Exhibit 1002 Page 10
`Biocon Exhibit 1002 Page 10
`
`
`
`1059
`
`at:
`
`Exhibit Description
`https://clinicaltrials.gov/ct2/history/NCT00685854?V_1=View#StudyP
`ageTop
`(“MACTEL Study”)
`1057 Authenticating Affidavit and the November 7, 2008 Web Archive of
`Ranibizumab Injections to Treat Macular Telangiectasia Without New
`Blood Vessel Growth (NCT00685854), available at
`https://web.archive.org/web/20081107014243/https://clinicaltrials.gov/
`ct2/show/NCT00685854, attached as Exhibit A (“MACTEL Study
`Wayback Machine”)
`available
`Machine,
`Wayback
`1058 Using
`the
`https://help.archive.org/help/using-the-wayback-machine/
`Eylea Label 2011, available at:
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125387lbl.
`1060 Glenn J. Jaffe, Paul Ashton, P. Andrew Pearson, Intraocular Drug
`Delivery (2006) (“Jaffe”)
`Steps for a Safe Intravitreal Injection Technique (2009), available at:
`https://www.retinalphysician.com/issues/2009/july-aug/steps-for-a-
`safe-intravitreal-injection-technique
`1062 Mylan’s Emergency Motion to Modify Scheduling Order and For
`Emergency Status Conference filed in Regeneron Pharmaceuticals, Inc.
`v. Mylan Pharmaceuticals Inc., Case No. 1:22-cv-00061-TSK, Northern
`District of West Virginia. (Dkt. 415) (“Mylan April 10 Motion”)
`1063 April 19, 2023 Claim Construction Order entered in Regeneron
`Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., Case No. 1:22-cv-
`00061-TSK, Northern District of West Virginia. (Dkt. 427) (“Mylan
`Litigation CC Order”)
`1064 U.S. Patent No. 7,531,173 (“’173 patent”)
`
`1061
`
`xi
`
`Samsung Bioepis Exhibit 1002 Page 11
`Biocon Exhibit 1002 Page 11
`
`
`
`I.
`
`INTRODUCTION
`I have been retained by the law firm Quinn Emanuel Urquhart &
`
`Sullivan on behalf of Samsung Bioepis Co., Ltd., (hereinafter, “Petitioner”) to
`
`provide expert opinions concerning antagonists of Vascular Endothelial Growth
`
`Factor (“VEGF”) used as intravitreal injection for the treatment of angiogenic
`
`disorders such as age related macular degeneration, diabetic retinopathy, diabetic
`
`macular edema, central retinal vein occlusion (CRVO), branch retinal vein occlusion,
`
`and corneal neovascularization.
`
`Specifically, I have been asked to provide my opinions related to U.S.
`
`Patent No. 11,253,572 (“the ’572 patent”) (Ex. 1001) and the scientific and technical
`
`knowledge regarding the subject matter of the ’572 patent before and for a period
`
`following the earliest priority date of the application that led to the ’572 patent. For
`
`purposes of this expert declaration, I have been asked to assume that the earliest
`
`priority date of the ’572 patent is January 13, 2011 for all claims other than claim
`
`25.
`
`My opinions in this declaration are based on the documents I cite along
`
`with my professional training, experience and knowledge that I have acquired
`
`working in the field of ophthalmology over the past 30 years. I am being
`
`compensated for my services as an expert at my standard consulting rate of $1500
`
`1
`
`Samsung Bioepis Exhibit 1002 Page 12
`Biocon Exhibit 1002 Page 12
`
`
`
`per hour. My compensation is in no way contingent on the substance of my opinions
`
`or the outcome of this case.
`
`My opinions and their underlying reasoning are explained in detail
`
`below.
`
`II.
`
`BACKGROUND AND QUALIFICATIONS
`I am an ophthalmologist with over 30 years of experience in the
`
`research, diagnosis, treatment, and analysis of vitreoretinal eye disorders. I received
`
`a Bachelor of Arts degree in Natural Sciences from Johns Hopkins University in
`
`1979. I obtained my Ph.D. in Cell Biology and Genetics from Cornell Graduate
`
`School of Medical Sciences in 1986 and my M.D. from Cornell University Medical
`
`College in 1987. I completed a pediatrics residency at Massachusetts General
`
`Hospital and an ophthalmology residency at Boston University Hospital. After my
`
`residency, I completed a Retina Fellowship at Massachusetts Eye & Ear Infirmary.
`
`From 1994 to 2000, I held the position of Assistant Professor of
`
`Ophthalmology at the University of Massachusetts Medical Center and served as the
`
`Interim Chief of Division of Ophthalmology between 1998 and 2000. From 2000 to
`
`2018, I was the Plough Foundation Professor of Retinal Diseases at the University
`
`of Tennessee Health Science Center, College of Medicine. I joined faculty at the
`
`University of Tennessee Health Science Center, College of Medicine in 2000. I held
`
`the position of Assistant Professor of Ophthalmology and Pediatrics between 2000
`
`2
`
`Samsung Bioepis Exhibit 1002 Page 13
`Biocon Exhibit 1002 Page 13
`
`
`
`and 2001, and Associate Professor of Ophthalmology (with tenure) between 2001
`
`and 2006. I became full professor of Ophthalmology in 2006 and Pediatrics in 2007.
`
`Between 2014 and 2018, I was the Director of Research at the Hamilton Eye Institute
`
`at the University of Tennessee Health Science Center.
`
`I joined faculty at the Vanderbilt University Medical Center in 2018,
`
`and since 2018, I have been the Margy Ann and J. Donald M. Gass Chair and
`
`Professor of Ophthalmology & Visual Sciences. I hold joint appointments in the
`
`Department of Pathology, Immunology and Microbiology and the Department of
`
`Biomedical Engineering.
`
`In my current and prior positions, I have been involved in the teaching
`
`and training of medical students, fellows, and residents in the area of
`
`ophthalmological surgical techniques, specifically, injection protocols for the
`
`administration of therapeutics for the treatment of age-related macular degeneration
`
`(AMD) and other vitreoretinal eye disorders. Further, since 2018, I began my
`
`current appointment as ophthalmologist at the Vanderbilt University Medical Center.
`
`I received numerous awards throughout my career. In 1998, I was
`
`awarded Research Career Award (K08) from the National Eye Institute, NIH.
`
`Between 2006 and 2013, I was elected to Best Doctors in America®. In 2009, I was
`
`awarded Senior Scientist Award from Research to Prevent Blindness. In 2013, I was
`
`awarded American Telemedicine Association Innovation Award for Hubble
`
`3
`
`Samsung Bioepis Exhibit 1002 Page 14
`Biocon Exhibit 1002 Page 14
`
`
`
`Telemedical, Inc. and B. Otto Wheeley Award for Excellence in Technology
`
`Transfer from the University of Tennessee. I have served as an editor, co-editor, or
`
`editorial reviewer on the editorial board of several publications, including PLoS One,
`
`American Journal of Ophthalmology, Archives of Ophthalmology, Autophagy,
`
`British Journal of Ophthalmology, British Journal of Pharmacology, Experimental
`
`Eye Research, Investigative Ophthalmology and Visual Science, Journal of Cellular
`
`Biochemistry, Journal of Cellular Physiology, Journal of Gene Medicine, Journal of
`
`Pharmacy and Pharmacology, Lipids, Molecular Vision, Ophthalmology, Pan
`
`American Journal of Public Health, PLoS ONE, Retina, Survey of Ophthalmology,
`
`IEEE Transactions in Medical Imaging, IEEE Computers in Biology and Medicine,
`
`SPIE, and others.
`
`I was and/or currently am a member in several Professional and
`
`Academic Societies, including American Academy of Ophthalmology, Association
`
`for Research in Vision and Ophthalmology, Alpha Omega Alpha Honor Medical
`
`Society, Retina Society, Macular Society, American Telemedicine Association,
`
`Research to Prevent Blindness, and Fight for Sight, among others.
`
`I have authored or co-authored over two hundred and fifty (250)
`
`publications, including book chapters, peer-reviewed scientific papers, abstracts,
`
`and other published works. These publications pertain to age-related macular
`
`4
`
`Samsung Bioepis Exhibit 1002 Page 15
`Biocon Exhibit 1002 Page 15
`
`
`
`degeneration, diabetic retinopathy (DR), and/or diabetic macular edema (DME),
`
`among other disorders of the eye.
`
`My clinical practice is focused on the diagnosis and treatment of
`
`patients suffering from all diseases of the retina, including age-related macular
`
`degeneration, diabetic retinopathy, diabetic macular edema, and related disorders, as
`
`well as uveitis. I have experience with surgical interventions as well as the
`
`prescription and administration of various
`
`intravitreally-administered anti-
`
`angiogenesis agents. I routinely administer anti-VEGF agents as part of my practice,
`
`and have for over fifteen years.
`
`In sum, I have over 30 years of hands-on clinical and research
`
`experience specializing in treating vitreoretinal disorders and the prescription, and
`
`intravitreal administration of VEGF antagonists. I have included a copy of my
`
`curriculum vitae in support of my opinions. Ex. 1003, Chaum CV.
`
`III.
`
`INFORMATION RELIED UPON
`In addition to my general knowledge gained as a result of my education
`
`and experience as an ophthalmologist, I have reviewed and considered, among other
`
`things, the ’572 patent, the prosecution history of the ’572 patent, and the prior art
`
`of record discussed herein.
`
`I also considered the Final Written Decision (“FWD”) issued by the
`
`Patent Trial and Appeal Board (“Board”) in IPR2021-00881 (“the ’338 IPR”)
`
`5
`
`Samsung Bioepis Exhibit 1002 Page 16
`Biocon Exhibit 1002 Page 16
`
`
`
`concerning U.S. Patent No. 9,254,338 (“’338 Patent”), finding all challenged claims
`
`there unpatentable. See Ex. 1011, ’338 FWD. I understand the ’338 and ’572 patents
`
`are in the same patent family and share the same specification. I have formed an
`
`opinion regarding the ’572 claims here independent of the ’338 FWD, but I found
`
`the ’338 FWD to be, in my judgment, consistent with my independent opinion
`
`expressed herein.
`
`I further considered the Institution Decision in IPR2022-01226 (“’601
`
`IPR”). I understand the ’601 IPR was instituted on January 11, 2023. Ex. 1013, ’601
`
`ID. I have formed an opinion regarding the ’572 claims here independent of the ’601
`
`ID, but I found the ’601 ID to be, in my judgment, consistent with my independent
`
`opinion expressed herein.
`
`The full list of information, in addition to my professional, academic
`
`and clinical experience, that I have relied upon in forming my opinions for this report
`
`is set forth throughout the report and in the Table of Exhibits.
`
`Where my conclusions are based on certain assumptions that I have
`
`adopted, I have stated such assumptions in this Declaration.
`
`IV. RELEVANT LEGAL STANDARD
`In forming my opinions and considering the patentability of the claims
`
`of the ’572 patent, I am relying upon certain legal principles that counsel for
`
`Petitioner have explained to me, as listed below.
`
`6
`
`Samsung Bioepis Exhibit 1002 Page 17
`Biocon Exhibit 1002 Page 17
`
`
`
`I understand that for an invention claimed in a patent to be found
`
`patentable, it must be, among other things, new and not obvious in light of what
`
`came before it. Patents and publications which predated the invention are generally
`
`referred to as “prior art.”
`
`For patent invalidity under an inter partes review, I understand the
`
`burden is on the party asserting unpatentability to prove it by a preponderance of the
`
`evidence. I understand that “a preponderance of the evidence” is evidence sufficient
`
`to show that a fact is more likely than not.
`
`A.
`
`Person of Ordinary Skill in the Art
`I have been informed that the claims of a patent are judged from the
`
`perspective of a hypothetical construct involving “a person of ordinary skill in the
`
`art” (“POSA”). The “art” is the field of technology to which the patent is related. I
`
`understand that the purpose of using a POSA’s viewpoint is objectivity. Thus, I
`
`understand that the question of validity is viewed from the perspective of a POSA,
`
`and not from the perspective of (a) the inventor, (b) a layperson, or (c) a person of
`
`extraordinary skill in the art. I have been informed that the claims of the ’572 patent
`
`are interpreted as a POSA would have understood them at the relevant time period
`
`(i.e., when the patent application was filed or the earliest effective filing date).
`
`I have been informed that in the ’338 IPR, the petitioner proposed – and
`
`the Board adopted – the following definition for the relevant POSA:
`
`7
`
`Samsung Bioepis Exhibit 1002 Page 18
`Biocon Exhibit 1002 Page 18
`
`
`
`A person of ordinary skill in the art at the time of the
`invention would have had (1) knowledge regarding the
`diagnosis and treatment of angiogenic eye disorders,
`including the administration of therapies to treat said
`disorders; and (2) the ability to understand results and
`findings presented or published by others in the field,
`including the publications discussed herein. Typically,
`such a person would have an advanced degree, such as an
`M.D. or Ph.D. (or equivalent, or less education but
`considerable professional experience in the medical,
`biotechnological, or pharmaceutical field), with practical
`academic or medical experience
`in (i) developing
`treatments for angiogenic eye disorders (such as AMD),
`including through the use of VEGF antagonists, or (ii)
`treating of same, including through the use of VEGF
`antagonists.
`Ex. 1011, ’338 FWD, 9-11.
`
`I understand that in the ’338 FWD, the Board found that petitioner’s
`
`definition was “reasonable and consistent with the ’338 Patent and the prior art or
`
`record.” Ex. 1011, ’338 FWD, 10.
`
`Based on my review of the patent and prior art, I agree with the Board’s
`
`definition of a POSA adopted in the ’338 FWD, and in my opinion it should be
`
`adopted here consistent with the relevant art before the earliest priority of the ’572
`
`patent.
`
`8
`
`Samsung Bioepis Exhibit 1002 Page 19
`Biocon Exhibit 1002 Page 19
`
`
`
`B.
`
`Claim Construction
`I understand the first step in determining whether a patent claim is valid
`
`is to properly construe the claims. I understand that each claim of a patent subject
`
`to inter partes review is to be interpreted in light of the language of the claim, the
`
`written description, the figures, and the prosecution history of the patent.
`
`I further understand that in the absence of a specific definition within
`
`the specification or the reliance on a specific meaning in the prosecution history, the
`
`terms as used in the challenged claims of the ’572 patent are to be afforded their
`
`plain and ordinary meaning at the time of the invention.
`
`I understand that the “plain and ordinary meaning” of a term means the
`
`ordinary and customary meaning given to the term by those of ordinary skill i