UNITED STATES PATENT AND TRADEMARK OFFICE
`
`———————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`———————
`
`ETON PHARMACEUTICALS, INC.,
`
`Petitioner
`
`v.
`
`EXELA PHARMA SCIENCES, LLC,
`
`Patent Owner
`
`———————
`
`U.S. PATENT NO. 10,653,719
`
`PGR2020-00086
`
`PETITIONER’S UPDATED INDEX OF EXHIBITS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`———————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`———————
`
`ETON PHARMACEUTICALS, INC.,
`
`Petitioner
`
`v.
`
`EXELA PHARMA SCIENCES, LLC,
`
`Patent Owner
`
`———————
`
`U.S. PATENT NO. 10,653,719
`
`PGR2020-00086
`
`PETITIONER’S UPDATED INDEX OF EXHIBITS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PGR2020-00086: Petitioner’s Updated Index of Exhibits
`
`PETITIONER’S EXHIBIT LIST
`
`Exhibit Description
`
`1001 U.S. Patent No. 10,583,155
`
`1002 U.S. Patent No. 10,478,453 File History
`
`1003 Declaration of Barrett Rabinow, Ph.D.
`
`1004 Affidavit of Christopher Butler
`
`1005 Way Back Machine Screenshots of
`https://web.archive.org/web/20170403170533/http:/drugsdb.eu/drug.p
`hp?d=L-
`cysteine%20Hydrochloride&m=Sandoz%20Inc&id=083366d6-0437-
`4ee0-90d4-440a5b5d03b5.xml and
`https://web.archive.org/web/20160824090050/http:/drugsdb.eu/drug.p
`hp?d=L-
`cysteine%20Hydrochloride&m=Sandoz%20Inc&id=083366d6-0437-
`4ee0-90d4-440a5b5d03b5.xml
`
`1006 A Hernández-Sánchez et al., Aluminum in Parenteral Nutrition: A
`Systematic Review, 67 EUR. J. CLINICAL NUTRITION 230 (2013)
`
`1007 Robert L. Poole et al., Aluminum in Pediatric Parenteral Nutrition
`Products: Measured Versus Labeled Content, 16 J. PEDIATRIC
`PHARMACOLOGY & THERAPEUTICS 92 (2011)
`
`1008 Denise Bohrer et al., Influence of the Glass Packing on the
`Contamination of Pharmaceutical Products by Aluminum. Part II:
`Amino Acids for Parenteral Nutrition, 15 J. TRACE ELEMENTS MED. &
`BIOLOGY 103 (2001) (“Bohrer II”)
`
`1009 Number Not Used
`
`1010 Number Not Used
`
`1011 Kavita Pilaniya et al., Recent Trends in the Impurity Profile of
`Pharmaceuticals, 3 J. ADVANCED PHARMACEUTICAL TECH. & RES. 302
`
`
`
`1
`
`
`
`PGR2020-00086: Petitioner’s Updated Index of Exhibits
`
`(2010)
`
`1012 Denise Bohrer et al., Influence of the Glass Packing on the
`Contamination of Pharmaceutical Products by Aluminum. Part III:
`Interaction Container-Chemicals During the Heating for Sterilisation,
`17 J. TRACE ELEMENTS MED. & BIOLOGY 107 (2003) (“Bohrer III”)
`
`1013 Q3D ELEMENTAL IMPURITIES: GUIDANCE FOR INDUSTRY (Sept. 2015)
`
`1014 Michael J Akers, Parenteral Preparations, in REMINGTON: THE
`SCIENCE AND PRACTICE OF PHARMACY 810 (David B. Troy et al. eds.,
`21st ed. 2006)
`
`1015 Winston W.K. Koo et al., Aluminum in Parenteral Nutrition
`Solution— Sources and Possible Alternatives, 10 J. PARENTERAL &
`ENTERAL NUTRITION 591 (1986)
`
`1016 Cysteine, DRUGBANK, https://www.drugbank.ca/drugs/DB00151 (last
`visited May 7, 2020)
`
`1017 Barrett E. Rabinow et al., Plastic Packaging Materials, in
`REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY 1047 (David
`B. Troy et al. eds., 21st ed. 2006)
`
`1018
`
`FDA GUIDANCE FOR INDUSTRY Q8(R2) PHARMACEUTICAL
`DEVELOPMENT, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
`FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION
`AND RESEARCH (CDER) CENTER FOR BIOLOGICS EVALUATION AND
`RESEARCH (CBER) (Nov. 2009)
`
`1019 August 4, 2017 Letter from Donna Griebel, M.D., Director of Division
`of Gastroenterology and Inborn Errors Products, CDER, to Patent
`Owner
`
`1020 Loyd V. Allen, L-Cysteine Hydrochloride 50 mg/mL Injection, 36 U.S.
`PHARMACIST 41 (Sept. 20, 2011)
`
`1021 ESSENTIALS OF PHARMACEUTICAL CHEMISTRY (Donald Cairns ed., 4th
`ed. 2012)
`
`
`
`2
`
`
`
`PGR2020-00086: Petitioner’s Updated Index of Exhibits
`
`1022 Declaration of Harry “Warren” Johnson, dated May 15, 2020
`
`1023 M.X. Sullivan et al., The Effect of Pyruvic Acid on the Estimation of
`Cystine and Cysteine, 122 J. BIOL. CHEM. 11 (1937)
`
`1024 R.S. Asquith et al., The Photochemical Degradation of Cystine in
`Aqueous Solution in the Presence of Air, 184 BIOCHIMICA ET
`BIOPHYSICA ACTA (BBA) – GENERAL SUBJECTS 345 (1969)
`
`1025
`
`Soji Rokushika et al., Radiolysis of Cystine in Aqueous Solution by
`Gamma Irradiation, 7-2 J. RADIATION RES. 47 (1966)
`
`1026 Ben H. Nicolet, Biochemistry by Analogy: The Sulfur of Cystine, 28 J.
`WASH. ACADS. SCI. 84 (1938)
`
`1027 Kenneth C. Waterman et al., Stabilization of Pharmaceuticals to
`Oxidative Degradation, 7 PHARMACEUTICAL DEV. & TECH. 1 (2002).
`
`1028 Henri J. R. Maget, Use of an Oxygen Extractor to Minimize Oxidation
`of Compounded Preparations, 3 INT’L J. PHARM. COMPOUNDING 493
`(1999)
`
`1029 Alpaslan Yaman, Engineering Considerations in Sterile Powder
`Processes, in STERILE PHARMACEUTICAL PRODUCTS: PROCESS
`ENGINEERING APPLICATIONS 297 (Kenneth E. Avis ed. 1995)
`
`1030 Copyright Registration Number for Alpaslan Yaman, Engineering
`Considerations in Sterile Powder Processes, in STERILE
`PHARMACEUTICAL PRODUCTS: PROCESS ENGINEERING APPLICATIONS
`297 (Kenneth E. Avis ed. 1995)
`
`1031
`
`Jalpa Patel et al., Stability Considerations for Biopharmaceuticals,
`Part 1: Overview of Protein and Peptide Degradation Pathways, 2011
`BIOPROCESS INT’L 20
`
`1032 Henry L. Avallone et al., Food and Drug Administration Inspection
`and Licensing of Manufacturing Facilities, in DRUG BIOTECHNOLOGY
`REGULATION: SCIENTIFIC BASIS AND PRACTICES 322-23 (Yuan-yuan H.
`Chiu et al. eds. 1991)
`
`
`
`3
`
`
`
`PGR2020-00086: Petitioner’s Updated Index of Exhibits
`
`1033 Gaozhong Zhu et al., Formulation of Protein- and Peptide-Based
`Parental Products, in PHARMACEUTICAL DOSAGE FORMS (Sandeep
`Nema et al. eds. 2010)
`
`1034 Andrew Teasdale et al., Impurities in New Drug Substances and New
`Drug Products: ICH Q3A/B: Key Guidelines in the General Impurity
`Management Process, in ICH QUALITY GUIDELINES: AN
`IMPLEMENTATION GUIDE (Andrew Teasdale et al. eds. 2018)
`
`1035 Aluminum in Large and Small Volume Parenterals Used in Total
`Parenteral Nutrition, 65 Fed. Reg. 4103 (Jan. 26, 2000) (codified at 21
`C.F.R. pt. 201)
`
`1036 G.J. Schuringa et al., The Reaction of Combined Cystine of Wool with
`Sodium Bisulfite, 21 TEXTILE RES. J. 281 (1951)
`
`1037 Lawrence X. Yu et al., Understanding Pharmaceutical Quality by
`Design, 16 AM. ASSOC. PHARM. SCIENTISTS J. 771 (2014
`
`1038 Victoria Lima-Rogel et al., Aluminum Contamination in Parenteral
`Nutrition Admixtures for Low-Birth-Weight Preterm Infants in Mexico,
`40 J. PARENTERAL AND ENTERAL NUTRITION 1014 (2016).
`
`1039 Number Not Used
`
`1040 Number Not Used
`
`1041 David Connaughton, Argon or Nitrogen: Which is Best for Your
`Application?, PARKER (Sept. 15, 2016), http://blog.parker.com/argon-
`or-nitrogen-which-is-best-for-your-application
`
`1042
`
`Prescribing Information for Selenious Acid Injection (revised 04/2019)
`
`1043
`
`July 10, 2019 Press Release regarding Selenious Acid Injection
`
`1044
`
`Prescribing Information for Zinc Sulfate Injection (revised 07/2019)
`
`1045 UCSF CHILDREN’S HOSPITAL INTENSIVE CARE NURSERY HOUSE STAFF
`MANUAL (2004-2006)
`
`
`
`4
`
`
`
`PGR2020-00086: Petitioner’s Updated Index of Exhibits
`
`1046 Reese H. Clark et al., Effects of Two Different Doses of Amino Acid
`Supplementation on Growth and Blood Amino Acid Levels in
`Premature Neonates Admitted to the Neonatal Intensive Care Unit: A
`Randomized, Controlled Trial, 129 PEDIATRICS 1286 (2007)
`
`1047 E. Friedmann et al., CCLXV, Reactions of Pyruvic Acid with
`Thiolacetic Acid and Cysteine, 30 BIOCHEM. J. 1886 (1936)
`
`1048 U.S. Patent No. 8,415,337 (“’337 patent”)
`
`1049 Number Not Used
`
`1050
`
` Number Not Used
`
`1051
`
` Number Not Used
`
`1052 Number Not Used
`
`1053 August 2017 Important Drug Warning Letter from Patent Owner to
`Health Care Provider
`
`1054 Aluminum in Large and Small Volume Parenterals Used in Total
`Parenteral Nutrition, 63 Fed. Reg. 176 (Jan. 5, 1998) (codified at 21
`C.F.R. 201)
`
`1055 W. Mihatsch, et al., ESPGHAN/ESPEN/ESPR/ESPEN Guidelines on
`Pediatric Parenteral Nutrition: Calcium, Phosphorus and Magnesium,
`37 CLINICAL NUTRITION (2018)
`
`1056 Dayong Luo et al., Kinetics and Mechanism of the Reaction of
`Cysteine and Hydrogen Peroxide in Aqueous Solution, 94 J. PHARM.
`SCI. 304 (2005)
`
`1057 CDER – NON-CLINICAL REVIEW(S), APP. NO. 210906ORIG1S000
`(signed 09/28/2018)
`
`1058 Arika Hanaki, et al., Manometric Study of the Copper-Catalyzed
`Oxidation of Cysteine, 19 CHEM. PHARM. BULL. 1006 (1971)
`
`
`
`
`5
`
`
`
`PGR2020-00086: Petitioner’s Updated Index of Exhibits
`
`1059 E. S. Guzman Barron, Thiol Groups of Biological Importance, in
`Advances in Enzymology and Related Subjects of Biochemistry 203-
`207 (F. F. Nord ed., 1951)
`
`1060 Number Not Used.
`
`1061 Len Okabe, Studies on the Solubility of Cystine Under Various
`Conditions, and On A New Method of Cystine Preparation, 8
`BIOCHEM. J. 441 (1927)
`
`1062 QUALITY BY DESIGN (QBD) APPROACHES FOR ORALLY INHALED AND
`NASAL DRUG PRODUCTS (OINDPS) IN THE USA, RDD EUROPE (2007)
`
`1063 Number Not Used.
`
`1064 Number Not Used.
`
`1065 Number Not Used.
`
`1066 Number Not Used.
`
`1067 Number Not Used.
`
`1068
`
`21 C.F.R. § 201.323
`
`1069 Kasra Kasaraian et al., Developing an Injectable Formula Containing
`an Oxygen-Sensitive Drug: A Case Study of Danofloxacin Injectable, 4
`PHARM. DEV. & TECH. 475 (1999)
`
`1070 Michael L. McHalsky, et al., Reduction of Aluminum Levels in
`Dialysis Fluids Through the Development and Use of Accurate and
`Sensitive Analytical Methodology, 41 J. PARENTERAL SCI. & TECH. 67
`(1987)
`
`1071 Barrett E. Rabinow et al., Aluminum in Parenteral Products: Analysis,
`Reduction and Implications for Pediatric TPN, 43 J. PARENTERAL SCI.
`& TECH. (1989)
`
`1072 Number Not Used.
`
`
`
`6
`
`
`
`PGR2020-00086: Petitioner’s Updated Index of Exhibits
`
`1073 Orange Book Screenshot for Elcys
`
`1074 DRUG FACTS AND COMPARISONS (2015)
`
`1075 Copyright Registration Number for DRUG FACTS AND COMPARISONS
`(2015)
`
`1076 USP 32/NF 18, The U.S. Pharmacopeial Convention (1995)
`
`1077 Eton Pharmaceuticals, Inc.’s August 11, 2020 Answer and Affirmative
`Defenses to Complaint in Exela Pharma Sciences, LLC v. Eton
`Pharmaceuticals, Inc., No. 20-00365-MN (D. Del., filed March 16,
`2020)
`
`1078 Declaration of Daniel Ingles
`
`1079
`
`SIGMA ALDRICH PRODUCT INFORMATION, L-CYSTEINE
`HYDROCHLORIDE MONOHYDRATE (05/06)
`
`1080 R.C. Whiting et al., Effect of Headspace Oxygen Concentration on
`Growth and Toxin Production by Proteolytic Strains of Clostridium
`Botulinum, 55 J. FOOD PROTECTION 23 (1992)
`
`1081
`
`Farideh Jalilehvand et al., Lead(II) Complex Formation with L-
`Cysteine in Aqueous Solution, 54 INORG. CHEM. 2160 (2015)
`
`1082
`
`Ian B. Butler et al., Removal of Dissolved Oxygen From Water: A
`Comparison of Four Common Techniques, 41 TALANTA 211 (1994)
`
`1083 Number Not Used.
`
`1084 Number Not Used.
`
`1085 Number Not Used.
`
`1086 Number Not Used.
`
`1087 Number Not Used.
`
`1088 Number Not Used.
`
`
`
`7
`
`
`
`PGR2020-00086: Petitioner’s Updated Index of Exhibits
`
`1089 Number Not Used.
`
`1090 Number Not Used.
`
`1091 Number Not Used.
`
`1092 Number Not Used.
`
`1093 Number Not Used.
`
`1094 BENTLEY’S TEXTBOOK OF PHARMACEUTICALS: AN ADAPTATION
`(Sanjay K. Jain eds. et al., 2012)
`
`1095 Number Not Used.
`
`1096 Number Not Used.
`
`1097 Number Not Used.
`
`1098 Number Not Used.
`
`1099 Number Not Used.
`
`1100 Number Not Used.
`
`1101 U.S. Patent No. 10,478,453
`
`1102 Number Not Used.
`
`1103 Number Not Used.
`
`1104 Number Not Used.
`
`1105 Number Not Used.
`
`1106 U.S. Patent No. 10,654,719
`
`1107 U.S. Patent No. 10,654,719 File History
`
`1108
`
`Stephen E. Langille, Particulate Matter in Injectable Drug Products,
`
`
`
`8
`
`
`
`PGR2020-00086: Petitioner’s Updated Index of Exhibits
`
`PDA J. PHARM. SCI. & TECH. 186, 186, 188 (2013)
`
`1109 Michael J. Akers, STERILE DRUG PRODUCTS: FORMULATION,
`PACKAGING, MANUFACTURING, AND QUALITY 434-36 (2010)
`
`1110 USP 32/NF 27 (The U.S. Pharmacopeial Convention, 2009)
`
`1111
`
`Salvatore J. Turco, Intravenous Admixtures, in REMINGTON: THE
`SCIENCE AND PRACTICE OF PHARMACY 810 (David B. Troy et al. eds.,
`21st ed. 2006)
`
`1112 Andy Rignall, ICHQ1A(R2) Stability Testing of New Drug Substance
`and Product and ICHQ1C Stability Testing of New Dosage Forms, in
`ICH QUALITY GUIDELINES: AN IMPLEMENTATION GUIDE 37 (Andrew
`Teasdale et al. eds., 2018)
`
`1113
`
`International Conference on Harmonisation; Guidance on Q6A
`Specifications: Test Procedures and Acceptance Criteria for New
`Drug Substances and New Drug Products: Chemical Substances, 65
`Fed. Reg. 83,041 (Dec. 29, 2000)
`
`1114
`
`FDA Warning Letter to Mr. Ian Reed, Pfizer, dated February 14, 2017
`
`1115
`
`Stability Studies, in HANDBOOK OF MODERN PHARMACEUTICAL
`ANALYSIS 466 (Satinder Ahuja eds. 2001)
`
`1116 Declaration of Harry “Warren” Johnson, dated August 24, 2020
`
`1117 Q1A(R2) STABILITY TESTING OF NEW DRUG SUBSTANCES AND
`PRODUCTS
`
`1118 August 26, 2020 Scheduling Order in Exela Pharma Sciences, LLC v.
`Eton Pharmaceuticals, Inc., No. 20-00365-MN (D. Del., filed March
`16, 2020)
`
`1119 THE MERCK INDEX: AN ENCYCLOPEDIA OF CHEMICALS, DRUGS, AND
`BIOLOGICALS (2006)
`
`1120 U.S. Patent No. 9,220,700
`
`
`
`9
`
`
`
`PGR2020-00086: Petitioner’s Updated Index of Exhibits
`
`1121
`
`July 23, 2020 Office Action in Application No. 16/746,028
`
`1122
`
`July 23, 2020 Office Action in Application No. 16/773,641
`
`1123 U.S. Patent No. 4,385,086
`
`1124 Transcript of Conference Call with Board taken February 8, 2021
`
`
`
`
`
`
`
`
`
`10
`
`
`
`PGR2020-00086: Petitioner’s Updated Index of Exhibits
`
`February 10, 2021
`
`Respectfully submitted,
`
`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No 34,167)
`HAYNES and BOONE LLP
`2323 Victory Ave. Suite 700
`Dallas, TX 75219
`Tel.: (312) 216-1620
`ralph.gabric.ipr@haynesboone.com
`
`Counsel for Petitioner
`
`11
`
`
`
`PGR2020-00086: Petitioner’s Updated Index of Exhibits
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.105 and 42.6, I certify that a true and correct copy
`
`of the forgoing document and new Exhibit 1124 were served on Patent Owner as
`
`detailed below.
`
`
`
`Date of service February 10, 2021
`
`Person served Dorothy P. Whelan
`PGR48751-0005PSa@fr.com
`
`Alana Mannige
`PTABInbound@fr.com
`
`
`
`
`
`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No 34,167)
`HAYNES AND BOONE LLP
`2323 Victory Ave. Suite 700
`Dallas, TX 75219
`Tel.: (312) 216-1620
`ralph.gabric.ipr@haynesboone.com
`Counsel for Petitioner
`
`
`
`
`
`12
`
`
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