UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________________
`
`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
`REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`_________________________
`
`Case IPR2023-00739
`
`U.S. Patent No. 10,888,601
`_________________________
`
`PETITION FOR INTER PARTES REVIEW
`OF U.S. PATENT NO. 10,888,601
`
`DECLARATION OF DR. EDWARD CHAUM
`
`Samsung Bioepis Exhibit 1002 - Page 1
`Biocon Exhibit 1002 - Page 1
`
`

`

`V.
`
`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...............................................................................8
`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.........................................................................................21
`Exclusion Criteria Intended to Reduce Risks Associated with
`Intravitreal Injections .........................................................................22
`VI. BACKGROUND OF THE ’601 PATENT ..................................................26
`A.
`General Description............................................................................26
`B.
`Prosecution History ............................................................................28
`VII. CHALLENGED CLAIMS ...........................................................................29
`VIII. CLAIM CONSTRUCTION .........................................................................29
`A.
`“A method for treating…” / “an effective amount” / “effective” ......30
`B. “Wherein the patient [loses less than/gains at least] 15 letters of
`Best Corrected Visual Acuity (BCVA) score” (Claims 13, 15,
`22, 23, 29, and 31)..............................................................................33
`
`F.
`
`ii
`
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`

`

`IX.
`
`X.
`
`C. “The method of [claims 15/23/32] wherein Best Corrected Visual
`Acuity (BCVA) is according to Early Treatment Diabetic
`Retinopathy Study (ETDRS) letter score” (Claims 14, 15, 20,
`24, 30, and 32)....................................................................................34
`D. “Exclusion Criteria”.................................................................................35
`PRIORITY DATE ........................................................................................36
`A.
`Applicable Legal Standard.................................................................36
`B.
`Claims 10-33 of the ’601 Patent Have an Earliest Effective
`Filing Date of July 12, 2013 at Best...................................................38
`INVALIDITY UNDER 35 U.S.C. § 103 .....................................................41
`A.
`Overview of the Prior Art...................................................................41
`1.
`September 14, 2009 Press Release ..........................................41
`2.
`Shams 2006..............................................................................41
`3.
`Elman 2010 ..............................................................................42
`4.
`CATT and PIER Studies..........................................................46
`Prior Art Knowledge Regarding the Relationship
`5.
`Between DR/DME ...................................................................49
`Analysis..............................................................................................51
`1.
`The 2009 Press Release Anticipates and/or Renders
`Obvious Dependent Claims 46 and 47 ....................................51
`Claims 10, 18, and 26 Are Rendered Obvious by the
`September 14, 2009 Press Release Either Alone Or In
`View Of Shams ........................................................................53
`The Regeneron September 14, 2009 Press Release in
`Combination with Elman 2010 Renders Obvious Claims
`10, 18, and 26...........................................................................59
`The Dependent Claims Are Rendered Obvious by the
`September 14, 2009 Press Release Alone or in View of
`Elman 2010 ..............................................................................69
`
`B.
`
`2.
`
`3.
`
`4.
`
`iii
`
`Samsung Bioepis Exhibit 1002 - Page 3
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`
`

`

`5.
`
`Claims 13-16, 20, 22-24, and 29-32 Are Rendered
`Obvious by the September 14, 2009 Press Release, Either
`Alone and in Combination with Elman 2010, and Further
`in View of Do 2011..................................................................71
`The 2016 Eylea Label Anticipates Claims 13-16, 20, 22-
`24, and 29-32............................................................................76
`Claims 17, 25, and 33 Are Rendered Obvious by the
`September 14, 2009 Press Release Alone or in View of
`Elman 2010 and Further in View of the CATT and PIER
`Studies......................................................................................79
`XI. NO SECONDARY CONSIDERATIONS ...................................................82
`XII. SUPPLEMENTATION................................................................................83
`
`6.
`
`7.
`
`iv
`
`Samsung Bioepis Exhibit 1002 - Page 4
`Biocon Exhibit 1002 - Page 4
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`

`

`TABLE OF EXHIBITS
`
`1001|US. Patent No. 10,888,601
`
`1003|Edward Chaum Curriculum Vitae
`
`1004‘|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”).
`
`1005__|
`
`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”)
`
`Elman MJ,et al., Randomizedtrial evaluating ranibizumab plus prompt
`or deferred laser or triamcinolone plus promptlaser for diabetic
`macular edema. Ophthalmology. 2010 Jun;117(6):1064-1077.e35.
`(“Elman 2010”)
`
`1007|HeierJS, et al., Intravitreal aflibercept (VEGF trap-eye) in wet age-
`related macular degeneration. Ophthalmology. 2012;119(12):2537-
`2548. (“Heier 2012”)
`
`1008|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”)
`
`f
`
`Press Release, Enrollment Completed in Regeneron and Bayer
`Healthcare Phase 3 Studies of VEGF Trap-Eye in Neovascular Age-
`Related Macular Degeneration (Wet AMD) (September14, 2009),
`https://newsroom.regeneron.com/news-releases/news-release-
`details/enrollment-completed-regeneron-and-bayer-healthcare-phase-3
`(“September 14, 2009 Press Release”’)
`
`1010|WO 2006/047325 Al (“Shams”)
`
`
`1011|Press Release, VEGF Trap-Eye Final Phase 2 Results in Age-Related
`Macular Degeneration Presented at 2008 Retina Society Meeting
`(September 28, 2008), https://investor.regeneron.com/news-
`
`SamsungBioepis Exhibit 1002 - Page 5
`Biocon Exhibit 1002 - Page 5
`
`

`

`1012|Certified Prosecution History of U.S. Patent No. 10,888,601 (“601
`patent PH”’)
`
`1013.|Adis R&D Profile, Aflibercept: AVE 0005, AVE 005, AVE000S,
`VEGFTrap - Regeneron, VEGF Trap (RIR2), VEGF Trap-Eye. Drugs
`R D. 2008:9(4):261-269. (“Adis”)
`
`1014|Elman MJ,et al., Randomizedtrial evaluating ranibizumabplus prompt
`or deferred laser or triamcinoloneplus promptlaser 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)
`
`
`
`History of Changes for Study: A Study of rhuFab V2 (Ranibizumab) in
`Subjects With Subfoveal Choroidal Neovascularization Secondary to
`
`1015|Lucentis ® Original Approved Labeling (2006), available at:
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125156s000
`Q Lucentis Prntlbl.pdf
`
`1016|Eylea Label 2023 availableat:
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125387s07
`SIbLpdf
`1017.|Comparison of Age-related Macular Degeneration Treatments Trials:
`Lucentis-Avastin Trial (NCT00593450), available at:
`https://clinicaltnials.gov/ct2/show/NCT00593450
`
`1018|Web Archive of the CATT Patient Eligibility Criteria (July 13, 2010),
`availableat:
`https://web.archive.org/web/20100713035617/http://www.med.upenn.e
`du/cpob/studies/documents/CATTEligibilityCriteria_000.pdf (“CATT
`Study”)
`
`1019|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 December3, 2007, available at
`https://www.ajo.com/article/S0002-9394(07)00881-1/fulltext (“PIER
`AJO Website”)
`
`1020
`
`SamsungBioepis Exhibit 1002 - Page 6
`Biocon Exhibit 1002 - Page 6
`
`

`

`Age-Related Macular Degeneration (AMD) (NCT00090623), available
`at:
`https://clinicaltrials.gov/ct2/history/NCT00090623?V_1=View#StudyP
`ageTop.
`
`1021|ClinicalTnals.gov Background,availableat:
`https://clinicaltnials.gov/ct2/about-site/background
`1022|ClinicalTnials.gov About the Results Database, available at:
`https://clinicaltrials.gov/ct2/about-site/results
`
`1023|Do DV et al., Incorporating the Latest Findings From Clinical Tnals
`Into the Management of Diabetic Retinopathy for the Comprehensive
`Ophthalmologist (October 25, 2009), available at:
`https://aao.scientificposters.com/epsView.cfm?xvTgEIiINo9X9FYIsrbB
`{IRKZIICSVGWM3JbEunzn9LGZqaMHKIw4tNfe%3D%3D (“Do
`workshop 2009”)
`
`1024|Pai A, El Shafei1 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”).
`1025|Final Written Decision in Mylan Pharmaceuticals Inc. v. Regeneron
`Pharmaceuticals, Inc., IPR2021-00881 (Paper 94) (“’338 FWD”)
`1026|U.S. Dep’t Health & Human Servs., Nat’] Inst. Health, Nat’] Eye Inst.,
`Diabetic Retinopathy: What You Should Know (Sept. 2015),
`https://www_nei.nih.gov/sites/default/files/health-
`pdfs/Diabetic Retinopathy What You Should Know.pdf (“NIH
`DR’).
`
`1027|U.S. Dep’t Health & HumanServs., Nat’! Inst. Health, Nat’] Eye Inst.,
`
`Age-Related Macular Degeneration: What You Should Know (Sept.
`
`2015),
`https://www.nei.nihgov/sites/default/files/healthpdfs/WYSK AMD E
`nglish Sept2015 PRINT.pdf (“NIH AMD”)
`
`1028|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”).
`
`Vii
`
`SamsungBioepis Exhibit 1002 - Page 7
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`

`

`1029|Holash J, Davis S, Papadopoulos N, et al. VEGF-Trap: a VEGF
`blocker with potent antitumoreffects. Proc Natl Acad SciU S A.
`2002;99(17):11393-11398. (“Holash’’)
`
`1030_|Rudge JS, Thurston G, DavisS, et al. VEGF trap as a novel
`antiangiogenic treatmentcurrently in clinical trials for cancer and eye
`diseases, and VelociGene- based discovery of the next generation of
`angiogenesis targets. Cold Spring Harb Symp QuantBiol.
`2005:70:411-418 (“Rudge 2005”)
`
`1031|Gomez-ManzanoC, Holash J, FueyoJ, et al. VEGF Trap induces
`antigliomaeffect at different stages of disease. Neuro Oncol.
`2008:10(6):940-945. (“Gomez-Manzano”)
`
`1032|US. Patent No. 7,531,173 (173 patent”)
`
`1033|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”)
`
`1034|LiE, 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”)
`
`1035|Brown DM,Michels M,Kaiser PK,et al. Ranibizumab versus
`verteporfin photodynamic therapy for neovascular age-related macular
`degeneration: Two-year results of the ANCHORstudy.
`Ophthalmology. 2009;116(1):57-65.e5. (“Brown 2009”)
`
`1036|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 bevacizumabfor treatment
`of neovascular age-related macular degeneration: two-yearresults.
`Ophthalmology 2012; 119(7):1388-98 (“Martin’’)
`
`bevacizumabto treat neovascular age-related macular degeneration: 1037|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
`
`vill
`
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`

`one-year findings from the IVAN randomizedtrial. Ophthalmology
`2012; 119(7):1399-411 (“Chakravarthy 2012”)
`
`1038|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’’)
`1039|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’’)
`
`1040|Jager RD, Aiello LP, Patel SC, Cunningham ET Jr. Risks of
`intravitreous injection: a comprehensive review.Retina.
`2004:24(5):676-698. (“Jager”)
`
`1047|Eylea Label 2011 available at:
`
`1041|Pilot Study ofIntravitreal Injection of Ranibizumab for Macular
`Telangiectasia With Neovascularization (NCT00685854) (May 24,
`2008), availableat:
`https://clinicaltrials.gov/ct2/history/NCT00685854?V_1=View#StudyP
`agelop (“MACTEL Study”)
`1042|Ranibizumab Injections to Treat Macular Telangiectasia Without New
`Blood Vessel Growth (NCT00685854) (November 7, 2008), available
`at:
`https://web.archive.org/web/20081107014243/https://clinicaltrials.gov/
`ct2/show/NCT00685854 (“MACTEL Study Wayback Machine’)
`
`1043|Using the Wayback Machine,availableat:
`https://help.archive.org/help/using-the-wayback-machine/
`
`1044|US. Patent App. Pub. US 2007/0190058A1
`
`1045|Do DVetal., The DA VINCIStudy:phase 2 primary results of VEGF
`Trap-Eye in patients with diabetic macular edema. Ophthalmology.
`2011 Sep:118(9):1819-26 (published online on May5, 2011). (“Do
`2011”)
`
`1046|Certified Prosecution History of U.S. Patent No. 10,130,681 B2 (“681
`patent PH”’)
`
`SamsungBioepis Exhibit 1002 - Page 9
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`

`

`Po https://www.accessdata.fda.gov/drugsatfda docs/label/2011/125387Ibl.
`
`pdf
`
`1048|Glenn J. Jaffe, Paul Ashton, P. Andrew Pearson, Intraocular Drug
`Delivery (2006) (“Jaffe”).
`
`1049|Steps for a Safe Intravitreal Injection Technique (2009), availableat:
`https://www.retinalphysician.com/issues/2009/july-aug/steps-for-a-
`safe-intravitreal-injection-technique
`
`1057.|WO 2012/097019A1 (“Yancopoulos PCT Application”)
`
`Do DVet al., The DA VINCIStudy:phase 2 primary results of VEGF
`Trap-Eye in patients with diabetic macular edema. Ophthalmology.
`2011 Sep;118(9):1819-26, available at:
`https://www.aaojournal.org/article/S0161-6420(1 1)00177-1/fulltext
`(“Do 2011 AAO Website”)
`1056|US. Patent No. 9,254,338 (“338 patent’)
`
`Eylea Label May 2016, available at
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125387s05
`LbLpdt (“Eylea 2016 Label’)
`
`Scheduling Order (Dkt. 87) entered in Regeneron Pharmaceuticals,
`Inc. v. Mylan Pharmaceuticals Inc., NDWV-1-22-cv-00061
`
`September 28, 2022 Status Conference Transcript entered in Regeneron
`Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc., NDWV-1-22-cv-
`00061
`
`Institution Decision in Mylan Pharmaceuticals Inc. v. Regeneron
`Pharmaceuticals, Inc., 1PR2022-01226 (Paper 22) (“601 ID”)
`
`Institution Decision in Mylan Pharmaceuticals Inc. v. Regeneron
`Pharmaceuticals, Inc., 1PR2022-01225 (Paper 21) (“681 ID”)
`
`SamsungBioepis Exhibit 1002 - Page 10
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`

`

`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. 10,888,601 (“the ’601 Patent”) (Ex. 1001) and the scientific and technical
`
`knowledge regarding the subject matter of the ’601 Patent before and for a period
`
`following the earliest priority date of the application that led to the ’601 Patent.
`
`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
`
`per hour. My compensation is in no way contingent on the substance of my opinions
`
`or the outcome of this case.
`
`1
`
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`

`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
`
`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.
`
`2
`
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`

`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 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
`
`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
`
`3
`
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`

`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
`
`degeneration, diabetic retinopathy (DR), and/or diabetic macular edema (DME),
`
`among other disorders of the eye.
`
`4
`
`Samsung Bioepis Exhibit 1002 - Page 14
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`

`

`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 ’601 Patent, the prosecution history of the ’601 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”)
`
`concerning U.S. Patent No. 9,254,338 (“’338 Patent”), finding all challenged claims
`
`there unpatentable. See Ex. 1025, ’338 FWD. I understand the ’338 and ’601 Patents
`
`5
`
`Samsung Bioepis Exhibit 1002 - Page 15
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`

`

`are in the same patent family and share the same specification. I have formed an
`
`opinion regarding the ’601 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
`
`(“Mylan IPR”). I understand the Mylan IPR was instituted on January 11, 2023. Ex.
`
`1053, ’601 ID. I have formed an opinion regarding the ’601 claims here independent
`
`of the ’601 ID, but I found the ’601 ID to be, in my judgment, consistent with my
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`independent opinion expressed herein.
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`The full list of information, in addition to my professional, academic
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`and clinical experience, that I have relied upon in forming my opinions for this report
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`is set forth throughout the report and in the Table of Exhibits.
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`Where my conclusions are based on certain assumptions that I have
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`adopted, I have stated such assumptions in this Declaration.
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`IV. RELEVANT LEGAL STANDARD
`In forming my opinions and considering the patentability of the claims
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`of the ’601 Patent, I am relying upon certain legal principles that counsel for
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`Petitioner have explained to me, as listed below.
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`I understand that for an invention claimed in a patent to be found
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`patentable, it must be, among other things, new and not obvious in light of what
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`came before it. Patents and publications which predated the invention are generally
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`referred to as “prior art.”
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`For patent invalidity under an inter partes review, I understand the
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`burden is on the party asserting unpatentability to prove it by a preponderance of the
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`evidence. I understand that “a preponderance of the evidence” is evidence sufficient
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`to show that a fact is more likely than not.
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`A.
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`Person of Ordinary Skill in the Art
`I have been informed that the claims of a patent are judged from the
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`perspective of a hypothetical construct involving “a person of ordinary skill in the
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`art” (“POSA”). The “art” is the field of technology to which the patent is related. I
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`understand that the purpose of using a POSA’s viewpoint is objectivity. Thus, I
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`understand that the question of validity is viewed from the perspective of a POSA,
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`and not from the perspective of (a) the inventor, (b) a layperson, or (c) a person of
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`extraordinary skill in the art. I have been informed that the claims of the ’601 Patent
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`are interpreted as a POSA would have understood them at the relevant time period
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`(i.e., when the patent application was filed or the earliest effective filing date).
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`I have been informed that in the ’338 IPR, the petitioner proposed – and
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`the Board adopted – the following definition for the relevant POSA:
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`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,
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`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. 1025, ’338 FWD, 9-11.
`
`I understand that in the ’338 FWD, the Board found that petitioner’s
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`definition was “reasonable and consistent with the ’338 Patent and the prior art or
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`record.” Ex. 1025, ’338 FWD, 10.
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`Based on my review of the patent and prior art, I agree with the Board’s
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`definition of a POSA adopted in the ’338 FWD, and in my opinion it should be
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`adopted here consistent with the relevant art before the earliest priority of the ’601
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`Patent.
`
`B.
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`Claim Construction
`I understand the first step in determining whether a patent claim is valid
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`is to properly construe the claims. I understand that each claim of a patent subject
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`to inter partes review is to be interpreted in light of the language of the claim, the
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`written description, the figures, and the prosecution history of the patent.
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`I further understand that in the absence of a specific definition within
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`the specification or the reliance on a specific meaning in the prosecution history, the
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`terms as used in the challenged claims of the ’601 Patent are to be afforded their
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`plain and ordinary meaning at the time of the invention.
`
`I understand that the “plain and ordinary meaning” of a term means the
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`ordinary and customary meaning given to the term by those of ordinary skill in the
`
`art at the time of the invention and that the ordinary and customary meaning of a
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`term may be evidenced by a variety of sources, including the words of the claims,
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`the specification, drawings, and prior art.
`
`I understand that in construing claims all words in a claim must be
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`considered in judging the patentability of that claim against the prior art.
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`I understand that extrinsic evidence may be consulted for the meaning
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`of a claim term as long as it is not used to contradict claim meaning that is
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`unambiguous in light of the intrinsic evidence. I also understand that in construing
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`claim terms, the general meanings gleaned from reference sources must always be
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`compared against the use of the terms in context, and the intrinsic record must always
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`be consulted to identify which of the different possible dictionary meanings is most
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`consistent with the use of the words by the inventor.
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`C.
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`Presumption of Validity
`I understand that a granted patent is presumed to be valid. I understand
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`that the presumption of validity can be overcome in district court litigations if clear
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`and convincing evidence is presented that proves the patent is invalid. I understand
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`that the standard of proof for invalidating a patent in an inter partes review
`
`proceeding is a “preponderance of the evidence” (i.e., greater than 50% chance of
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`likelihood), which is a lower standard than the clear and convincing evidence
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`standard.
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`D.
`
`Obviousness
`I understand that even if a patent claim is not anticipated, it is still
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`invalid if the differences between the claimed subject matter and the prior art are
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`such that the subject matter as a whole would have been obvious at the time the
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`invention was made to a person of ordinary skill in the pertinent art.
`
`I understand that a person of ordinary skill in the art provides a
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`reference point from which the prior art and claimed invention should be viewed.
`
`This reference point prevents one from using his or her own insight or hindsight in
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`deciding whether a claim is obvious.
`
`I also understand that an obviousness determination includes the
`
`consideration of various factors such as (1) the scope and content of the prior art, (2)
`
`the differences between the prior art and the asserted claims, (3) the level of ordinary
`
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`skill in the pertinent art, and (4) the existence of secondary considerations or
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`objective indicia of obviousness or non-obviousness.
`
`I understand that an obviousness determination can be based on a single
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`prior art reference or a combination of multiple prior art references or the knowledge
`
`of one of ordinary skill in the art. I understand that the prior art itself may provide
`
`a suggestion, motivation, or reason to combine or modify the teachings of the prior
`
`art, or that such a reason may come from other sources, such as the knowledge of a
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`person having ordinary skill in the art, common sense, and market forces. I
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`understand that the following rationales may support a finding of obviousness:
`
` combining prior art elements according to known methods to yield
`
`predictable results;
`
` simple substitution of one known element for another to obtain
`
`predictable results;
`
` use of known technique to improve similar devices (methods, or
`
`products) in the same way;
`
` applying a known technique to a known device (method or product)
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`ready for improvement to yield predictable results;
`
` “obviou