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. 10,478,453
`
`PGR2020-00064
`
`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. 10,478,453
`
`PGR2020-00064
`
`PETITIONER’S UPDATED INDEX OF EXHIBITS
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PGR2020-00064: Petitioner’s Updated Index of Exhibits
`
`Petitioner’s Index of Exhibits
`
`Exhibit Description
`
`1001
`
`U.S. Patent No. 10,478,453 (“’453 patent”)
`
`1002
`
`U.S. Patent No. 10,478,453 File History
`
`1003
`
`Declaration of Barrett Rabinow, Ph.D.
`
`1004
`
`Affidavit of Christopher Butler
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`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
`
`A Hernández-Sánchez et al., Aluminum in Parenteral Nutrition: A
`Systematic Review, 67 EUR. J. CLINICAL NUTRITION 230 (2013)
`
`Robert L. Poole et al., Aluminum in Pediatric Parenteral Nutrition
`Products: Measured Versus Labeled Content, 16 J. PEDIATRIC
`PHARMACOLOGY & THERAPEUTICS 92 (2011)
`
`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”)
`
`Way Back Machine Screenshots of
`https://web.archive.org/web/20130831172706/http:/www.drugsdb.eu/d
`rug.php?d=Aminosyn&m=Hospira,%20Inc.&id=2A72A8B8-A77C-
`49C6-3C8D-43B03672D802.xml
`
`1010
`
`Affidavit of Christopher Butler
`
`ii
`
`
`
`PGR2020-00064: Petitioner’s Updated Index of Exhibits
`
`1011
`
`1012
`
`Kavita Pilaniya et al., Recent Trends in the Impurity Profile of
`Pharmaceuticals, 3 J. ADVANCED PHARMACEUTICAL TECH. & RES. 302
`(2010)
`
`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
`
`1015
`
`1016
`
`1017
`
`1018
`
`Michael J Akers, Parenteral Preparations, in REMINGTON: THE
`SCIENCE AND PRACTICE OF PHARMACY 810 (David B. Troy et al. eds.,
`21st ed. 2006)
`
`Winston W.K. Koo et al., Aluminum in Parenteral Nutrition
`Solution— Sources and Possible Alternatives, 10 J. PARENTERAL &
`ENTERAL NUTRITION 591 (1986)
`
`Cysteine, DRUGBANK, https://www.drugbank.ca/drugs/DB00151 (last
`visited May 7, 2020)
`
`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)
`
`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)
`
`
`
`3
`
`
`
`PGR2020-00064: Petitioner’s Updated Index of Exhibits
`
`1021
`
`ESSENTIALS OF PHARMACEUTICAL CHEMISTRY (Donald Cairns ed., 4th
`ed. 2012)
`
`1022
`
`Declaration of Harry “Warren” Johnson
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`M.X. Sullivan et al., The Effect of Pyruvic Acid on the Estimation of
`Cystine and Cysteine, 122 J. BIOL. CHEM. 11 (1937)
`
`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)
`
`Soji Rokushika et al., Radiolysis of Cystine in Aqueous Solution by
`Gamma Irradiation, 7-2 J. RADIATION RES. 47 (1966)
`
`Ben H. Nicolet, Biochemistry by Analogy: The Sulfur of Cystine, 28 J.
`WASH. ACADS. SCI. 84 (1938)
`
`Kenneth C. Waterman et al., Stabilization of Pharmaceuticals to
`Oxidative Degradation, 7 PHARMACEUTICAL DEV. & TECH. 1 (2002).
`
`Henri J. R. Maget, Use of an Oxygen Extractor to Minimize Oxidation
`of Compounded Preparations, 3 INT’L J. PHARM. COMPOUNDING 493
`(1999)
`
`Alpaslan Yaman, Engineering Considerations in Sterile Powder
`Processes, in STERILE PHARMACEUTICAL PRODUCTS: PROCESS
`ENGINEERING APPLICATIONS 297 (Kenneth E. Avis ed. 1995)
`
`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
`
`
`
`4
`
`
`
`PGR2020-00064: Petitioner’s Updated Index of Exhibits
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`REGULATION: SCIENTIFIC BASIS AND PRACTICES 322-23 (Yuan-yuan H.
`Chiu et al. eds. 1991)
`
`Gaozhong Zhu et al., Formulation of Protein- and Peptide-Based
`Parental Products, in PHARMACEUTICAL DOSAGE FORMS (Sandeep
`Nema et al. eds. 2010)
`
`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)
`
`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)
`
`G.J. Schuringa et al., The Reaction of Combined Cystine of Wool with
`Sodium Bisulfite, 21 TEXTILE RES. J. 281 (1951)
`
`Lawrence X. Yu et al., Understanding Pharmaceutical Quality by
`Design, 16 AM. ASSOC. PHARM. SCIENTISTS J. 771 (2014
`
`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).
`
`Ulrich Reichert et al., Metal Residue: How Much is Too Much?,
`PHARMA MANUFACTURING (Aug. 19, 2013)
`
`Diane L. Tribble et al., Hypercysteinemia and Delayed Sulfur
`Excretion in Cirrhotics After Oral Cysteine Loads, 50 Am. Soc.
`Clinical Nutrition 1401 (1989)
`
`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)
`
`
`
`5
`
`
`
`PGR2020-00064: Petitioner’s Updated Index of Exhibits
`
`1043
`
`July 10, 2019 Press Release regarding Selenious Acid Injection
`
`1044
`
`Prescribing Information for Zinc Sulfate Injection (revised 07/2019)
`
`1045
`
`1046
`
`UCSF CHILDREN’S HOSPITAL INTENSIVE CARE NURSERY HOUSE STAFF
`MANUAL (2004-2006)
`
`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
`
`1050
`
`1051
`
`Maaike A. Riedijk et al., Cysteine: A Conditionally Essential Amino
`Acid In Low-Birth-Weight Preterm Infants?, 86 AM. J. CLIN.
`NUTRITION 1120 (2007)
`
`A. D. Patrick, The Degradative Metabolism of L-Cysteine and L-
`Cystine In Vitro By Liver in Cystinosis, 83 BIOCHEM. J. 248 (1962)
`
`Soghier LM et al., CYSTEINE, CYSTINE OR N-ACETYLCYSTEINE
`SUPPLEMENTATION IN PARENTERALLY FED NEONATES (REVIEW),
`COCHRANE DATABASE OF SYSTEMATIC REVIEWS (2010).
`
`1052
`
`Screenshot of https://www.rxlist.com/aminosyn-sulfite-free-drug.htm
`
`1053
`
`1054
`
`1055
`
`August 2017 Important Drug Warning Letter from Patent Owner to
`Health Care Provider
`
`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)
`
`W. Mihatsch, et al., ESPGHAN/ESPEN/ESPR/ESPEN Guidelines on
`Pediatric Parenteral Nutrition: Calcium, Phosphorus and Magnesium,
`37 CLINICAL NUTRITION (2018)
`
`
`
`6
`
`
`
`PGR2020-00064: Petitioner’s Updated Index of Exhibits
`
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`1063
`
`1064
`
`Dayong Luo et al., Kinetics and Mechanism of the Reaction of
`Cysteine and Hydrogen Peroxide in Aqueous Solution, 94 J. PHARM.
`SCI. 304 (2005)
`
`CDER – NON-CLINICAL REVIEW(S), APP. NO. 210906ORIG1S000
`(signed 09/28/2018)
`
`Arika Hanaki, et al., Manometric Study of the Copper-Catalyzed
`Oxidation of Cysteine, 19 CHEM. PHARM. BULL. 1006 (1971)
`
`
`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)
`
`Daniel Rudman et al., Hypotyrosinemia, Hypocystinemia, and Failure
`to Retain Nitrogen During Total Parenteral Nutrition of Cirrhotic
`Patients, 81 GASTROENTEROLOGY 1025 (1981)
`
`Len Okabe, Studies on the Solubility of Cystine Under Various
`Conditions, and On A New Method of Cystine Preparation, 8
`BIOCHEM. J. 441 (1927)
`
`QUALITY BY DESIGN (QBD) APPROACHES FOR ORALLY INHALED AND
`NASAL DRUG PRODUCTS (OINDPS) IN THE USA, RDD EUROPE (2007)
`
`Walter D. Block et al., Methionine, Cysteine, Cystine, and Taurine
`Interrelationships in Human Plasma, 22 AM. J. CLINICAL NUTRITION
`33 (1969)
`
`Mary Fewtrell et al., Symposium 2: Micronutrients Under the
`Microscope Aluminium Exposure From Parenteral Nutrition in
`Preterm Infants and Later Health Outcomes During Childhood and
`Adolescence, 70 PROCEEDINGS OF THE NUTRITION SOC. 299 (2011)
`
`1065
`
`Charles J. J. Fox, On the Coefficients of Absorption of Nitrogen and
`Oxygen in Distilled Water and Sea-Water and of Atmospheric
`
`
`
`7
`
`
`
`PGR2020-00064: Petitioner’s Updated Index of Exhibits
`
`Carbonic Acid in Sea-Water, 5 TRANS. FARAD. SOC., 68 (1909)
`
`1066
`
`STANDARD METHODS FOR THE EXAMINATION OF WATER AND SEWAGE,
`APHA (2d ed. 1915)
`
`1067
`
`U.S. Patent No. 6,382,442 (“’442 patent”)
`
`1068
`
`21 C.F.R. § 201.323
`
`1069
`
`1070
`
`1071
`
`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)
`
`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)
`
`Barrett E. Rabinow et al., Aluminum in Parenteral Products: Analysis,
`Reduction and Implications for Pediatric TPN, 43 J. PARENTERAL SCI.
`& TECH. (1989)
`
`1072
`
`George C. Whipple et al., Solubility of Oxygen in Sea Water, 33 J. AM.
`CHEM. SOC. 362 (1911)
`
`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 May 6, 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,
`
`
`
`8
`
`
`
`PGR2020-00064: Petitioner’s Updated Index of Exhibits
`
`2020)
`
`1078
`
`Declaration of Daniel Ingles
`
`1079
`
`1080
`
`1081
`
`1082
`
`SIGMA ALDRICH PRODUCT INFORMATION, L-CYSTEINE
`HYDROCHLORIDE MONOHYDRATE (05/06)
`
`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)
`
`Farideh Jalilehvand et al., Lead(II) Complex Formation with L-
`Cysteine in Aqueous Solution, 54 INORG. CHEM. 2160 (2015)
`
`Ian B. Butler et al., Removal of Dissolved Oxygen From Water: A
`Comparison of Four Common Techniques, 41 TALANTA 211 (1994)
`
`1083
`
`Transcript of Conference Call with Board taken September 21, 2020
`
`1084
`
`1085
`
`1086
`
`1087
`
`1088
`
`Excerpt From the File History of Pending Application No. 16/746,028
`– As-Filed Claims (Jan. 17, 2020)
`
`Excerpt From the File History of Pending Application No. 16/773,641
`– As-Filed Claims (Jan. 27, 2020)
`
`Excerpt From the File History of Pending Application No. 16/746,028
`– Notice of Allowance (May 14, 2020)
`
`Excerpt From the File History of Pending Application No. 16/773,641
`– Notice of Allowance (April 30, 2020)
`
`Excerpt From the File History of Pending Application No. 16/746,028
`– Request for Continued Examination (May 28, 2020) and Information
`Disclosure Statement (June 11, 2020)
`
`1089
`
`Excerpt From the File History of Pending Application No. 16/773,641
`– Request for Continued Examination (June 2, 2020) and Information
`
`
`
`9
`
`
`
`PGR2020-00064: Petitioner’s Updated Index of Exhibits
`
`Disclosure Statement (June 11, 2020)
`
`1090
`
`1091
`
`1092
`
`1093
`
`1094
`
`Excerpt From the File History of Pending Application No. 16/746,028
`– Non-Final Rejection (July 23, 2020)
`
`Excerpt From the File History of Pending Application No. 16/773,641
`– Non-Final Rejection (July 23, 2020)
`
`Excerpt From the File History of Pending Application No. 16/746,028
`– Information Disclosure Statement (April 17, 2020)
`
`Excerpt From the File History of Pending Application No. 16/773,641
`– Information Disclosure Statement (April 17, 2020)
`
`Declaration of John Geissler, Exhibit 1, Response in Opposition to
`Plaintiff’s Motion for Preliminary Injunction, Exela Pharma Sciences,
`LLC v. Sandoz, Inc., No. 1:19-cv-318 (W.D.N.C., Dec. 6, 2019)
`
`September 28, 2020
`
`
`
`
`
`,
`
`
`/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
`
`
`
`
`
`
`
`
`10
`
`
`
`PGR2020-00064: Petitioner’s Updated Index of Exhibits
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.105 and 42.6, I certify I caused a true and correct
`
`copy of Petitioner’s Updated Index of Exhibits and Exhibits 1084-1094 on Patent
`
`Owner as detailed below.
`
`
`
`Date of service September 28, 2020
`
`Person served Dorothy P. Whelan
`PGR48751-0005PS1@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
`
`
`
`
`
`11
`
`
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