IPR2020-00084
`Patent 9,089,519
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`PROLLENIUM US INC.,
`Petitioner,
`
`v.
`
`ALLERGAN INDUSTRIE, SAS,
`Patent Owner.
`
`_________________
`
`Case IPR2020-00084
`U.S. Patent 9,089,519
`_________________
`
`
`
`
`
`PATENT OWNER ALLERGAN INDUSTRIE, SAS’S
`UPDATED EXHIBIT LIST
`
`
`
`
`Patent 9,089,519
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_________________
`
`PROLLENIUM US INC.,
`Petitioner,
`
`v.
`
`ALLERGAN INDUSTRIE, SAS,
`Patent Owner.
`
`_________________
`
`Case IPR2020-00084
`U.S. Patent 9,089,519
`_________________
`
`
`
`
`
`PATENT OWNER ALLERGAN INDUSTRIE, SAS’S
`UPDATED EXHIBIT LIST
`
`
`
`
`
`IPR2020-00084
`Patent 9,089,519
`
`EXHIBITS
`
`Exhibit No.
`2001
`2002
`2003
`2004
`
`2005
`2006
`2007
`2008
`2009
`2010
`2011
`
`2012
`
`2013
`2014
`2015
`
`2016
`
`2017
`
`Exhibit Description
`Juvéderm Ultra™ XC Label
`Juvéderm Ultra Plus™ XC Label
`Juvéderm Voluma®XC Label
`U.S. Patent Publication No. 2004/0101959 to Marko et al,
`published May 27, 2004
`Excerpts from U.S. 8,822,676 file history
`Excerpts from U.S. 9,089,519 file history
`About Juvéderm Ultra Plus™ XC
`About Juvéderm Volbella® XC
`About Juvéderm Voluma® XC
`Reserved
`Declaration in support of unopposed motion for pro hac vice
`admission of Elizabeth Flanagan
`Updated Declaration in support of unopposed motion for pro hac
`vice admission of Elizabeth Flanagan
`Declaration of Cory J. Berkland, Ph.D
`Curriculum Vitae, Cory J. Berkland, Ph.D.
`Kuo, Practical Aspects of Hyaluronan Based Medical Products,
`Chs. 1-6, 2006. (“Kuo”)
`Hascall and Laurent, Hyaluronan: Structure and Physical
`Properties, Hyaluronan Today, Vol. 1, 1997,
`https://www.glycoforum.gr.jp/article/01A2.html. (“Hascall”)
`Cleland, et al., Polyelectrolyte Properties of Sodium Hyaluronate.
`2. Potentiometric Titration of Hyalyuronic Acid, Macromolecules
`Vol. 15, 1982; 386-395. (“Cleland”)
`
`
`
`
`
`
`
`-ii-
`
`
`
`
`
`IPR2020-00084
`Patent 9,089,519
`
`Exhibit Description
`Knill, et al., Effect of Metal Ions on the Rheological Flow Profiles
`of Hyaluronate Solutions, Kennedy Ch. 21, Hyaluronan, 2002;
`175-180. (“Knill”)
`Kablik, et al., Comparative Physical Properties of Hyaluronic
`Acid Dermal Fillers, Dermatologic Surgery, Vol. 35, 2009; 302-
`312. (“Kablik”)
`Reserved
`Lapcik, et al., Hyaluronan: Preparation, Structure, Properties,
`and Applications, Chemical Reviews, Vol. 98, No. 8, 1998; 2664-
`2684. (“Lapcik”)
`Kubota and Shimoda, Macromolecular Complexes of Chitosan,
`Dumitriu Ch. 29, Polysaccharides Structural Diversity and
`Functional Versatility, 2nd Ed., 2005; 679-706. (“Kubota”)
`Matsumoto, et al., Reducing the Discomfort of Lidocaine
`Administration through pH Buffering, Journal of Vascular and
`Interventional Radiology, Vol. 5, No. 1, 1994; 171-175.
`(“Matsumoto”)
`International Publication No. WO 2005/112888 (Wang).
`Reserved
`Bajpai and Giri, Swelling Dynamics of A Macromolecular
`Hydrophilic Network and Evaluation of Its Potential For
`Controlled Release of Agrochemicals, Reactive & Functional
`Polymers, Vol. 53, 2002; 125-141. (“Bajpai”)
`Ghosh, et al., Rheological Characterization of in Situ Cross-
`Linkable Hyaluronan Hydrogels, Biomacromolecules, Vol. 6,
`2005; 2857-2865. (“Ghosh”)
`Leach and Schmidt, Hyaluronan; Encyclopedia of Biomaterials
`and Biomedical Engineering, 2004; 779-789. (“Leach”)
`Wik, Rheology of Hyaluronan Products, Kennedy Ch. 24,
`Hyaluronan, 2002; 201-204. (“Wik”)
`
`-iii-
`
`
`
`Exhibit No.
`2018
`
`2019
`
`2020
`2021
`
`2022
`
`2023
`
`2024
`2025
`2026
`
`2027
`
`2028
`
`2029
`
`
`
`
`
`
`
`
`
`IPR2020-00084
`Patent 9,089,519
`
`Exhibit Description
`Scott and Heatley, Biological Properties of Hyaluronan are
`Controlled and Sequestered by Tertiary Structures, Kennedy Ch.
`15, Hyaluronan, 2002; 117-122. (“Scott”)
`Mo, et al., Effects of Sodium Chloride, Guanidine Hydrochloride,
`and Sucrose on the Viscoelastic Properties of Sodium Hyaluronate
`Solutions, Biopolymers, Vol. 50, 1999; 23-34. (“Mo”)
`Lefebvre and Doublier, Rheological Behavior of Polysaccharides
`Aqueous Systems, Dumitriu Ch. 13, Polysaccharides Structural
`Diversity and Functional Versatility, 2nd Ed., 2005; 357-394.
`(“Lefebvre”)
`Hoefling, et al., Rheological Creep Experiments Utilizing Mixtures
`of 1% Hylan A Solution and 0.5% Hylan B Gel Slurry, Kennedy
`Ch. 23, Hyaluronan, 2002; 195-200. (“Hoefling”)
`Forbes, et al., Bailey & Scott’s Diagnostic Microbiology, 10th Ed.,
`1998; 1-6. (“Bailey”)
`Ege, Organic Chemistry Structure and Reactivity, 3rd Ed., 1994;
`530. (“Ege”)
`Inoue and Nagasawa, Preparation, by Chemical Degradation of
`Hyaluronic Acid, of a Series of Even- and Odd-Numbered
`Oligosaccharides Having A 2-Acetamido-2-Deoxy-D-Glucose and
`A D-Glucuronic Acid Residue, Respectively, at the Reducing End,
`Carbohydrate Research, Vol. 141, 1985; 99-110. (“Inoue”)
`Tokita and Okamoto, Degradation of Hyaluronic Acid-Kinetic
`Study and Thermodynamics, European Polymer Journal, Vol. 32,
`No. 8, 1996; 1011-1014. (“Tokita 1996”)
`Tokita and Okamoto, Hydrolytic Degradation of Hyaluronic Acid,
`Polymer Degradation and Stability, Vol. 48, 1995; 269-273.
`(“Tokita 1995”)
`Tømmeraas and Melander, Kinetics of Hyaluronan Hydrolysis in
`Acidic Solution at Various pH Values, Biomacromolecules, Vol. 9,
`2008; 1535-1540. (“Tømmeraas”)
`-iv-
`
`
`
`Exhibit No.
`2030
`
`2031
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`
`
`
`
`
`
`
`
`IPR2020-00084
`Patent 9,089,519
`
`Exhibit Description
`Lowry and Beavers, Thermal Stability of Sodium Hyaluronate in
`Aqueous Solution, Journal of Biomedical Materials Research, Vol.
`28, 1994; 1239-1244. (“Lowry”)
`Bothner, et al., Limiting Viscosity Number and Weight Average
`Molecular Weight of Hyaluronate Samples Produced by Heat
`Degradation, International Journal of Biological Macromolecules,
`Vol. 10, 1988; 287-291. (“Bothner”)
`Powell, Stability of Lidocaine in Aqueous Solution: Effect of
`Temperature, pH, Buffer, and Metal Ions on Amide Hydrolysis,
`Pharmaceutical Research, Vol. 4, No. 1, 1987; 42-45. (“Powell”)
`The Merck Index, An Encyclopedia of Chemicals, Drugs, and
`Biologicals, 12th Ed., 1996; 936-937. (“1996 Merck Index:
`Lidocaine”)
`Bromage, A Comparison of the Hydrochloride and Carbon
`Dioxide Salts of Lidocaine and Prilocaine in Epidural Analgesia,
`Acta Anaesthesiologica Scandinavica, Supplementum XVI, 1965;
`55-69. (“Bromage”)
`U.S. Patent No. 4,582,865 (Balazs).
`U.S. Patent Publication No. 2006/0122147 (Wohlrab).
`Barbucci et al., Hyaluronic Acid Hydrogel in the Treatment of
`Osteoarthritis, Biomaterials, Vol. 23, 2002; 4503-4513.
`(“Barbucci”)
`Reserved
`Brandt and Cazzaniga, Hyaluronic Acid Fillers: Restylane and
`Perlane, Facial Plastic Surgery Clinics of North America, Vol. 15,
`2007; 63-76. (“Brandt”)
`Declaration of Amelia E. Murray.
`Zhao, et al., Synthesis and Characterization of A Novel Double
`Crosslinked Hyaluronan Hydrogel, Journal of Materials Science:
`Materials in Medicine, Vol. 13, 2002; 11-16. (“Zhao”)
`
`-v-
`
`
`
`Exhibit No.
`2040
`
`2041
`
`2042
`
`2043
`
`2044
`
`2045
`2046
`2047
`
`2048
`2049
`
`2050
`2051
`
`
`
`
`
`
`
`
`
`IPR2020-00084
`Patent 9,089,519
`
`Exhibit No.
`2052
`
`2056
`
`2057
`
`2058
`2059
`
`Exhibit Description
`Ballin, et al., Long-term Efficacy, Safety and Durability of
`Juvéderm® XC, Clinical, Cosmetic and Investigational
`Dermatology, Vol. 6, 2013; 183-189. (“Ballin”)
`2053-2054 Reserved
`2055
`Khabarov, et al., Chemical Modifications, Solid Phase, Radio-
`Chemical and Enzymatic Transformations of Hyaluronic Acid,
`Polyak Ch. 5, Hyaluronic Acid: Preparation, Properties,
`Application in Biology and Medicine, 1st Ed., 2015; 121-141.
`(“Khabarov”)
`Onesti et al., Assessment of A New Hyaluronic Acid Filler.
`Double-blind, Randomized, Comparative Study Between Puragen
`and Captique in the Treatment of Nasolabial Folds, In Vivo, Vol.
`23, 2009; 479-486. (“Onesti”)
`Application for Patent Term Extension of U.S. Pat. No. 5,827,937
`(Ågerup).
`U.S. Patent No. 5,827,937 (Ågerup).
`Micheels et al., Effect of Difference Crosslinking Technologies on
`Hyaluronic Acid Behavior: A Visual and Microscopic Study of
`Seven Hyaluronic Acid Gels, Journal of Drugs in Dermatology,
`Vol. 15, No. 5, 2016; 600-606. (“Micheels 2016”)
`Micheels and Eng, Rheological Properties of Several Hyaluronic
`Acid-Based Gels: A Comparative Study, Journal of Drugs in
`Dermatology, Vol. 17, No. 9, 2018; 948-954. (“Micheels 2018”)
`Stocks et al., Rheological Evaluation of the Physical Properties of
`Hyaluronic Acid Dermal Fillers, Journal of Drugs in
`Dermatology, Vol. 10, No. 9, 2011; 974-980. (“Stocks”)
`Shah and Barnett, Hyaluronic Acid Gels, Harland and
`Prud’homme Ch. 7, Polyelectrolyte Gels, 1992; 116-130. (“Shah”)
`
`2060
`
`2061
`
`2062
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`
`
`
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`
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`-vi-
`
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`
`IPR2020-00084
`Patent 9,089,519
`
`Exhibit Description
`Busso, Calcium Hyroxylapatite (Radiesse®): Safety, Techniques
`and Pain Reduction, Journal of Drugs in Dermatology, Vol. 8, No.
`10, 2009; s21-s23. (“Busso 2009”)
`Busso and Voigts, An Investigation of Changes in Physical
`Properties of Injectable Calcium Hydroxylapatite in a Carrier Gel
`when Mixed with Lidocaine and with Lidocaine/Epinepherine,
`Dermatologic Surgery, Vol. 34, 2008; s16-s24. (“Busso 2008”)
`Reserved
`U.S. Patent No. 5,880,107 (Buenter).
`U.S. Patent No. 8,455,465 (Molliard).
`Balazs, et al., Applications of Hyaluronan and Its Derivatives,
`Biotechnological Polymers, 1993; 41-65. (“Balazs”)
`U.S. Patent No. 5,017,229 (Burns).
`Collins and Birkinshaw, Comparison of the Effectiveness of Four
`Different Crosslinking Agents with Hyaluronic Acid Hydrogel
`Films for Tissue-Culture Applications, Journal of Applied Polymer
`Science, Vol. 104, 2007; 3183-3191. (“Collins 2007”)
`Collins and Birkinshaw, Physical Properties of Crosslinked
`Hyaluronic Acid Hydrogels, Journal of Materials Science:
`Materials Science in Medicine, Vol. 19, 2008; 3335–3343.
`(“Collins 2008”)
`Shah and Barnett, Swelling Behavior of Hyaluronic Acid Gels,
`Journal of Applied Polymer Science, Vol. 45, 1992; 293-298.
`(“Shah II”)
`Reserved
`Liao, et al., Hyaluronan: Pharmaceutical Characterization and
`Drug Delivery, Drug Delivery, Vol. 12, No. 6, 2005; 327-342.
`(“Liao”)
`
`-vii-
`
`
`
`Exhibit No.
`2063
`
`2064
`
`2065
`2066
`2067
`2068
`
`2069
`2070
`
`2071
`
`2072
`
`2073
`2074
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`
`
`
`
`
`
`
`
`IPR2020-00084
`Patent 9,089,519
`
`Exhibit No.
`2075
`
`2079
`
`2080
`
`2081
`2082
`2083
`
`Exhibit Description
`Artes Medical Initiates Market Launch and Commercial Sale of
`Elevess, a New FDA-Approved Hyaluronic Acid-Based Dermal
`Filler, Business Wire, 2008,
`https://www.businesswire.com/news/home/20080805005349/en/A
`rtes-Medical-Initiates-Market-Launch-Commercial-Sale.
`2076-2077 Reserved
`2078
`Clark, Shelf Life of Medical Devices, FDA Guidance, 1991,
`https://www.fda.gov/regulatory-information/search-fda-guidance-
`documents/shelf-life-medical-devices. (“Clark”)
`Falcone, et al., Biomedical Applications of Hyaluronic Acid,
`Marchessault et al. Ch. 8, Polysaccharides for Drug Delivery and
`Pharmaceutical Applications, 2006; 155-174. (“Falcone”)
`Wieland, et al., Non-Viral Vector Delivery From PEG-Hyaluronic
`Acid Hydrogels, Journal of Controlled Release, Vol. 120, No. 3,
`2007. (“Wieland”)
`Curriculum Vitae, Pierre F. Lebreton, Ph.D.
`Reserved
`Vivacy Laboratories Testing Report on FR0857575, with
`translation,
`https://register.epo.org/application?documentId=ER83XYVA8475
`754&number=EP09768146&lng=fr&npl=true.
`Vivacy Laboratories Testing Report on EP2 349 203 B1, with
`translation,
`https://register.epo.org/application?documentId=EWD1Y85G8021
`FI4&number=EP09768146&lng=fr&npl=false.
`Kuo, et al., Chemical Modification of Hyaluronic Acid by
`Carbodiimides, Bioconjugate Chemistry, Vol. 2, 1991; 232-241.
`(“Kuo 1991”)
`U.S. Patent No. 4,963,666 (Mälson).
`
`2084
`
`2085
`
`2086
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`-viii-
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`IPR2020-00084
`Patent 9,089,519
`
`Exhibit No.
`2087
`
`2088
`
`Exhibit Description
`Agalloco, et al., Aseptic Processing: A Review of Current Industry
`Practice, Pharmaceutical Technology, 2004; 126-150.
`(“Agalloco”)
`Kuroda, et al., Interactions Between Local Anesthetics and Na+
`Channel Inactivation Gate Peptides in Phosphatidylserine
`Suspensions as Studied by 1H-NMR Spectroscopy, Chemical and
`Pharmaceutical Bulletin, Vol. 48, No. 9, 2000; 1293-1298.
`(“Kuroda”)
`Anslyn and Dougherty, Solutions and Non-Covalent Binding
`Forces, Ch. 3, Modern Physical Organic Chemistry, 2006; 145-
`205. (“Anslyn”)
`Simon, et al., Mechanisms Controlling Diffusion and Release of
`Model Proteins Through and From Partially Esterified
`Hyaluronic Acid Membranes, Journal of Controlled Release, Vol.
`61, 1999; 267-279. (“Simon”)
`Anika Therapeutics Inc., 2006 Annual Report,
`http://www.annualreports.co.uk/HostedData/AnnualReportArchiv
`e/a/NASDAQ_ANIK_2006.pdf.
`Ruiz-Cardona, et al., Application of Benzyl Hyaluronate
`Membranes as Potential Wound Dressings: Evaluation of Water
`Vapour and Gas Permeabilities, Biomaterials, Vol. 17, 1996;
`1639-1643. (“Ruiz-Cardona”)
`Bulpitt and Aeschlimann, New Strategy for Chemical Modification
`of Hyaluronic Acid: Preparation of Functionalized Derivatives
`and Their Use in the Formation of Novel Biocompatible
`Hydrogels, Journal of Biomaterials Research, Vol. 47, No. 2,
`1999; 152-169. (“Bulpitt”)
`Maleki, et al., Effect of pH on the Behavior of Hyaluronic Acid in
`Dilute and Semidilute Aqueous Solutions, Macromolecular
`Symposia, Vol. 274, 2008; 131-140. (“Maleki”)
`2095-2099 Reserved
`
`2089
`
`2090
`
`2091
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`2092
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`2093
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`2094
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`-ix-
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`IPR2020-00084
`Patent 9,089,519
`
`2106
`
`2123
`
`Exhibit Description
`Exhibit No.
`Transcript of the Deposition of Dale DeVore
`2100
`2101-2104 Reserved
`2105
`Anika Therapeutics, Inc., SEC Form 10-k, 2006,
`https://www.sec.gov/Archives/edgar/data/898437/0001104659070
`18715/0001104659-07-018715-index.htm. (Ex. 05 to DeVore
`Dep.)
`FDA Premarket Approval, CTA Suppl. 004,
`https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cf
`m?id=P050033S004. (Ex. 06 to DeVore Dep.)
`2107-2121 Reserved
`2122
`FDA Premarket Approval, CTA Suppl. 001. (Ex. 22 to DeVore
`Dep.)
`FDA Premarket Approval, CTA Suppl. 003,
`https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cf
`m?id=P050033S001. (Ex. 23 to DeVore Dep.)
`2124-2127 Reserved
`2128
`U.S. Pat. No. 9,352,046 (DeVore). (Ex. 28 to DeVore Dep.)
`2129
`ESM Technologies, Inc. v BIOVA, LLC and Matthew Stegenga,
`C.A. No. 6:10-cv-03009-RED (W.D. Mo. 2011), Declaration of
`Dale Paul DeVore, Ph.D. (Ex. 29 to DeVore Dep.)
`Curriculum Vitae of Dale P. DeVore, Ph.D, submitted in Biocell
`Technology, LLC v. ARTHRO-7 INC., C.A. No. 8:12-cv-00516-
`JVS-RNB (C.D. Ca. Mar. 25, 2013). (Ex. 30 to DeVore Dep.)
`2131-2134 Reserved
`2135
`Mentor Corporation, Press Release and Third Quarter Financial
`Results, 2006,
`https://www.sec.gov/Archives/edgar/data/64892/00000648920600
`0005/k8feb0606results.htm. (Ex. 35 to DeVore Dep.)
`
`2130
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`IPR2020-00084
`Patent 9,089,519
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`Exhibit No.
`2136
`
`2137
`
`2138
`
`Exhibit Description
`Mentor Corporation, SEC Form 10-Q, 2006,
`https://www.sec.gov/Archives/edgar/data/64892/00010032970600
`0047/0001003297-06-000047-index.htm. (Ex. 36 to DeVore Dep.)
`Mentor Corporation, SEC Form 10-K, 2006,
`https://www.sec.gov/Archives/edgar/data/64892/00000648920600
`0023/0000064892-06-000023-index.htm. (Ex. 37 to DeVore Dep.)
`Mentor Corporation, SEC Form 10-K, 2007,
`https://www.sec.gov/Archives/edgar/data/64892/00013623100700
`0951/0001362310-07-000951-index.htm. (Ex. 38 to DeVore
`Dep.)
`Mentor Corporation, SEC Form 10-K, 2008,
`https://www.sec.gov/Archives/edgar/data/64892/00013623100800
`3062/0001362310-08-003062-index.htm. (Ex. 39 to DeVore Dep.)
`Identification of Expert Witness in International Trade
`Commission Inv. No. 337-TA-515 (2004). (Ex. 40 to DeVore
`Dep.)
`2141-2147 Reserved
`2148
`Silver, et al., Viscoelastic Evaluation of Different Hyaluronic Acid
`Based Fillers Using Vibrational Optical Coherence Tomography,
`Materials Sciences and Applications, Vol. 10, 2019; 423-431. (Ex.
`48 to DeVore Dep.)
`Pendant Modification Figure. (Ex. 49 to DeVore Dep.)
`2149
`2150-2151 Reserved
`2152
`Figure Depicting Chemical Structure of DEO. (Ex. 52 to DeVore
`Dep.)
`Figure Depicting Chemical Structure of BDDE. (Ex. 53 to DeVore
`Dep.)
`Figure Depicting Chemical Structure of DVS. (Ex. 54 to DeVore
`Dep.)
`
`2139
`
`2140
`
`2153
`
`2154
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`-xi-
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`IPR2020-00084
`Patent 9,089,519
`
`Exhibit No.
`2155
`
`2156
`
`2157
`2158
`
`Exhibit Description
`Figure Depicting Incorrect Chemical Structure of pBCDI. (Ex. 55
`to DeVore Dep.)
`Figure Depicting Correct Chemical Structure of pBCDI. (Ex. 56 to
`DeVore Dep.)
`Reserved
`Figure Depicting Chemical Structure of NaHA. (Ex. 58 to DeVore
`Dep.)
`2159-2164 Reserved
`2165
`Lidocaine Quiz. (Ex. 65 to DeVore Dep.)
`2166-2171 Reserved
`2172
`Declaration of Dale P. DeVore in U.S. Patent Application No.
`13/813,557. (Ex. 72 to DeVore Dep.)
`Declaration of Dale P. Devore in U.S. Patent Application No.
`14/430,741. (Ex. 73 to DeVore Dep.)
`Figures Depicting Chemical Structures of Crosslinked HA. (Ex. 74
`to DeVore Dep.)
`Deposition Transcript of Glenn Prestwich, Ph.D. (Nov. 23-24,
`2020).
`
`2173
`
`2174
`
`2200
`
`
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`-xii-
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`IPR2020-00084
`Patent 9,089,519
`
`Exhibit No.
`
`Exhibit Description
`Dep. Ex. 2200B – Declaration of Glenn Prestwich in Galderma v.
`Allergan, IPR2014-01417, Ex. 1041 (April 17, 2014).1
`Dep. Ex. 2200E – Declaration of Glenn Prestwich in Galderma v.
`Allergan, IPR2014-01422, Ex. 1041 (April 17, 2014).
`Dep. Ex. 2200G – Declaration of Glenn Prestwich in Teoxane v.
`Allergan, IPR2017-02002, Ex. 1041 (Aug. 19, 2017).
`Dep. Ex. 2200I – Declaration of Glenn Prestwich in Teoxane v.
`Allergan, IPR2017-01906, Ex. 1041 (July 31, 2017).
`
`
`1 Patent Owner submits Dr. Prestwich’s prior declarations (Exs. 2200B,
`
`2200E, 2200G and 2200I) as part of the deposition transcript. These declarations
`
`regard two of the patents at issue in these related IPR proceedings and contradict
`
`numerous positions taken by Petitioner and Dr. Prestwich in these proceedings.
`
`Petitioner did not serve them pursuant to 37 C.F.R. § 42.51(b)(1)(iii). Patent
`
`Owner uses these exhibits for impeachment purposes to evaluate the credibility of
`
`Dr. Prestwich’s statements in these proceedings. See, e.g., Actelion Pharm. LTD v.
`
`ICOS Corp., IPR2015-00562, Paper 50 at 32 (PTAB, Aug. 3, 2015) (Snedden,
`
`APJ).
`
`
`
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`
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`-xiii-
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`
`Exhibit No.
`
`IPR2020-00084
`Patent 9,089,519
`
`Exhibit Description
`Dep. Ex. 2200L – Information Disclosure Statement, U.S. Patent
`Application No. 14/242,747.*2
`Dep. Ex. 2200M – Information Disclosure Statement, U.S. Patent
`Application No. 13/746,170.*
`Dep. Ex. 2200N – Information Disclosure Statement, U.S. Patent
`Application No. 13/891,052.*
`Dep. Ex. 2200V – Prestwich, From Classroom to Courtroom: Can
`Academics Be Effective Expert Witnesses?, Materials Today, Vol.
`15, No. 9, 2012; 406-09.*
`Dep. Ex. 2200W – 21 C.F.R. § 500.26 (2008).*
`Dep. Ex. 2200Z – GOODMAN & GILMAN’S THE
`PHARMACOLOGICAL BASIS OF THERAPEUTICS, 10th ed., 2001; 6.*
`Dep. Ex. 2200CC – U.S. Patent No. 5,502,081. (“Prestwich
`1996”)*
`Dep. Ex. 2200FF – Prestwich et al., Chemical Modification of
`Hyaluronic Acid for Drug Delivery, Biomaterials and Biochemical
`Probes, The Chemistry, Biology, and Medical Applications of
`Hyaluronan and Its Derivatives, 1998; 43-65.*
`
`
`2 Patent Owner submits exhibits marked with an asterisk (*)in support of
`
`Patent Owner’s Motion to Exclude Evidence. These exhibits are also provided as
`
`exhibits to the transcript of Dr. Prestwich’s deposition. Patent Owner uses these
`
`exhibits for impeachment and to evaluate the credibility of Dr. Prestwich’s
`
`statements. See, e.g., Actelion Pharm. LTD v. ICOS Corp., IPR2015-00562, Paper
`
`50 at 32 (PTAB, Aug. 3, 2015) (Snedden, APJ).
`
`
`
`
`
`
`
`-xiv-
`
`
`
`
`
`IPR2020-00084
`Patent 9,089,519
`
`Exhibit No.
`
`2201
`2202
`
`Exhibit Description
`Dep. Ex. 2200HH – U.S. Patent No. 6,096,027. (“Prestwich
`2000”)*
`Dep. Ex. 2200ZZ – Mathiowitz, Food and Drug Administration
`Requirements for Controlled Release Products, Encyclopedia of
`Controlled Drug Delivery, 1999; 381-394.*
`Dep. Ex. 2200AAA – Burgess et al., Assuring Quality and
`Performance of Sustained and Controlled Release Parenterals:
`Workshop Report, AAPS PharmSci, Vol. 4, No. 2, 2002; 1-11.*
`Dep. Ex. 2200FFF – Lidocaine, PUBCHEM,
`https://pubchem.ncbi.nlm.nih.gov/compound/Lidocaine#section=S
`olubility (last visited Nov. 19, 2020).*
`Pre-Hearing Conference Transcript (Jan. 5, 2021).
`Motion to Exclude Hearing Transcript (Jan. 12, 2021).
`
`-xv-
`
`
`
`CERTIFICATE OF SERVICE
`
`IPR2020-00084
`Patent 9,089,519
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on January 20,
`
`2021, a complete and entire copy of PATENT OWNER’S UPDATED EXHIBIT
`
`LIST with supporting exhibits has been served in its entirety by e-mail on the
`
`following counsel of record for Petitioner:
`
`Lead Counsel:
`Warren J. Thomas
`(Reg. No. 70,581)
`MEUNIER CARLIN & CURFMAN LLC
`999 Peachtree Street NE, Suite 1300
`Atlanta, GA 30309
`wthomas@mcciplaw.com
`
`
`
`
`Dated: January 20, 2021
`
`
`
`
`
`
`
`Backup Counsel:
`Christopher L. Curfman (Reg. No. 52,787)
`William W. Cutchins (Reg. No. 63,451)
`John Harbin (pro hac vice motion filed)
`Anthony J. Zucchero (Reg. No. 71,827)
`MEUNIER CARLIN & CURFMAN LLC
`999 Peachtree Street NE, Suite 1300
`Atlanta, GA 30309
`ccurfman@mcciplaw.com
`wcutchins@mcciplaw.com
`mcc.prollenium.ipr@mcciplaw.com
`azucchero@mcciplaw.com
`
`
`
`/Anthony M. Insogna/
`Anthony M. Insogna (Reg. No. 35,203)
`JONES DAY
`4655 Executive Drive, Suite 1500
`San Diego, CA 92121
`Telephone: 858-314-1200
`Fax: 844-345-3178
`
`Attorney for Patent Owner
`
`
`
`
`
`
`
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