Case number PGR2020-00086
Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences LLC > Documents
| Date Field | Doc. No. | Party | Description |
|---|---|---|---|
| Jan 27, 2021 | 2021 | patent_own | Download |
| Jan 27, 2021 | 2020 | patent_own | Excerpt From the File History of U.S. Patent Application No. 16/773,641 Download |
| Jan 27, 2021 | 2019 | patent_own | Excerpt From the File History of U.S. Patent Application No. 16/746,028 Download |
| Jan 27, 2021 | 2018 | patent_own | Eton Letter to Judge Noreika, Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc. Download |
| Jan 27, 2021 | 2017 | patent_own | Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, Inc., PGR2020-00068, Paper 11 Download |
| Jan 27, 2021 | 2016 | patent_own | Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, Inc., PGR2020-00068, Paper 1 Download |
| Jan 27, 2021 | 2015 | patent_own | Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, Inc., PGR2020-00064, Paper 12 Download |
| Jan 27, 2021 | 2014 | patent_own | Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, Inc., PGR2020-00064, Paper 1 Download |
| Jan 27, 2021 | 2013 | patent_own | Eton Pharmaceuticals, Inc., Amendment No. 1 to Sales/Marketing Agreement Download |
| Jan 27, 2021 | 2012 | patent_own | Robert L. Poole et al., Aluminum Exposure From Pediatric Parenteral Nutrition: Meeting the New FDA Regulation Download |
| Jan 27, 2021 | 2011 | patent_own | Jay M. Mirtallo, Aluminum Contamination of Parenteral Nutrition Fluids Download |
| Jan 27, 2021 | 2010 | patent_own | Gordon L. Klein et al., Hypocalcemia Complicating Deferoxamine Therapy in an Infant with Parenteral Nutrition-Associated Aluminum Overload: Evidence for a Role of Aluminum in the Bone Disease of Infants Download |
| Jan 27, 2021 | 2009 | patent_own | Kathleen M. Gura, Aluminum Contamination in Parenteral Products Download |
| Jan 27, 2021 | 2008 | patent_own | Megan Fortenberry et al., Evaluating Differences in Aluminum Exposure Through Parenteral Nutrition in Neonatal Morbidities Download |
| Jan 27, 2021 | 2007 | patent_own | Declaration of Mark Hartman (Redacted), Exela Pharma Sciences, LLC v. Sandoz Inc. Download |
| Jan 27, 2021 | 2006 | patent_own | Amended Complaint, Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc. Download |
| Jan 27, 2021 | 2005 | patent_own | Amended Complaint (Redacted), Exela Pharma Sciences, LLC v. Sandoz, Inc. Download |
| Jan 27, 2021 | 2004 | patent_own | ELCYS Label, Exela Pharma Sciences, LLC Download |
| Jan 27, 2021 | 2003 | patent_own | Nicholas J. Bishop et al., Aluminum Neurotoxicity in Preterm Infants Receiving Intravenous-Feeding Solutions Download |
| Jan 27, 2021 | 2002 | patent_own | Aileen B. Sedman et al., Evidence of Aluminum Loading in Infants Receiving Intravenous Therapy Download |
| Jan 27, 2021 | 2001 | patent_own | Declaration of Dr. Robert J. Kuhn Download |
| Feb 17, 2021 | 1126 | petitioner | Download |
| Feb 17, 2021 | 1125 | petitioner | Download |
| Feb 10, 2021 | 1124 | petitioner | Transcript of Conference Call with Board taken February 8, 2021 Download |
| Sep 21, 2020 | 1123 | petitioner | U.S. Patent No. 4,385,086 Download |
| Sep 21, 2020 | 1122 | petitioner | July 23, 2020 Office Action in Application No. 16/773,641 Download |
| Sep 21, 2020 | 1121 | petitioner | July 23, 2020 Office Action in Application No. 16/746,028 Download |
| Sep 21, 2020 | 1120 | petitioner | U.S. Patent No. 9,220,700 Download |
| Sep 21, 2020 | 1119 | petitioner | THE MERCK INDEX: AN ENCYCLOPEDIA OF CHEMICALS, DRUGS, AND BIOLOGICALS (2006) Download |
| Sep 21, 2020 | 1118 | petitioner | August 26, 2020 Scheduling Order in Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., No. 20-00365-MN (D. Del.) Download |
| Sep 21, 2020 | 1117 | petitioner | Q1A(R2) STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS Download |
| Sep 21, 2020 | 1116 | petitioner | Download |
| Sep 21, 2020 | 1115 | petitioner | Stability Studies, in HANDBOOK OF MODERN PHARMACEUTICAL ANALYSIS Download |
| Sep 21, 2020 | 1114 | petitioner | FDA Warning Letter to Mr. Ian Reed, Pfizer, dated February 14, 2017 Download |
| Sep 21, 2020 | 1113 | petitioner | 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 Download |
| Sep 21, 2020 | 1112 | petitioner | Rignall, ICHQ1A(R2) Stability Testing of New Drug Substance and Product and ICHQ1C Stability Testing of New Dosage Forms Download |
| Sep 21, 2020 | 1111 | petitioner | Turco, Intravenous Admixtures Download |
| Sep 21, 2020 | 1110 | petitioner | USP 32/NF 27 (The U.S. Pharmacopeial Convention, 2009) Download |
| Sep 21, 2020 | 1109 | petitioner | Akers, STERILE DRUG PRODUCTS: FORMULATION, PACKAGING, MANUFACTURING, AND QUALITY Download |
| Sep 21, 2020 | 1108 | petitioner | Langille, Particulate Matter in Injectable Drug Products Download |
| Sep 21, 2020 | 1107 | petitioner | U.S. Patent No. 10,654,719 File History Download |
| Sep 21, 2020 | 1106 | petitioner | U.S. Patent No. 10,654,719 Download |
| Sep 21, 2020 | 1101 | petitioner | U.S. Patent No. 10,478,453 Download |
| Sep 21, 2020 | 1094 | petitioner | Download |
| Sep 21, 2020 | 1082 | petitioner | Butler et al., Removal of Dissolved Oxygen From Water: A Comparison of Four Common Techniques Download |
| Sep 21, 2020 | 1081 | petitioner | Jalilehvand, Lead(II) Complex Formation with L-Cysteine in Aqueous Solution Download |
| Sep 21, 2020 | 1080 | petitioner | Whiting, Effect of Headspace Oxygen Concentration on Growth and Toxin Production by Proteolytic Strains of Clostridium Botulinum Download |
| Sep 21, 2020 | 1079 | petitioner | SIGMA ALDRICH PRODUCT INFORMATION, L-CYSTEINE HYDROCHLORIDE MONOHYDRATE (05/06) Download |
| Sep 21, 2020 | 1078 | petitioner | Declaration of Daniel Ingles Download |
| Sep 21, 2020 | 1077 | petitioner | Download |
| Sep 21, 2020 | 1076 | petitioner | USP 32/NF 18, The U.S. Pharmacopeial Convention (1995) Download |
| Sep 21, 2020 | 1075 | petitioner | Copyright Registration Number for DRUG FACTS AND COMPARISONS (2015) Download |
| Sep 21, 2020 | 1074 | petitioner | DRUG FACTS AND COMPARISONS (2015) Download |
| Sep 21, 2020 | 1073 | petitioner | Orange Book Screenshot for Elcys Download |
| Sep 21, 2020 | 1071 | petitioner | Rabinow, Aluminum in Parenteral Products: Analysis, Reduction and Implications for Pediatric TPN Download |
| Sep 21, 2020 | 1070 | petitioner | McHalsky, Reduction of Aluminum Levels in Dialysis Fluids Download |
| Sep 21, 2020 | 1069 | petitioner | Kasaraian et al., Developing an Injectable Formula Containing an Oxygen-Sensitive Drug Download |
| Sep 21, 2020 | 1068 | petitioner | Download |
| Sep 21, 2020 | 1062 | petitioner | QUALITY BY DESIGN (QBD) APPROACHES FOR ORALLY INHALED AND NASAL DRUG PRODUCTS (OINDPS) IN THE USA, RDD EUROPE (2007) Download |
| Sep 21, 2020 | 1061 | petitioner | Okabe, Studies on the Solubility of Cystine Under Various Conditions, and On A New Method of Cystine Preparation Download |
| Sep 21, 2020 | 1059 | petitioner | Guzman Barron, Thiol Groups of Biological Importance Download |
| Sep 21, 2020 | 1058 | petitioner | Hanaki, Manometric Study of the Copper-Catalyzed Oxidation of Cysteine Download |
| Sep 21, 2020 | 1057 | petitioner | Download |
| Sep 21, 2020 | 1056 | petitioner | Luo, Kinetics and Mechanism of the Reaction of Cysteine and Hydrogen Peroxide in Aqueous Solution Download |
| Sep 21, 2020 | 1055 | petitioner | Mihatsch, ESPGHAN/ESPEN/ESPR/ESPEN Guidelines on Pediatric Parenteral Nutrition: Calcium, Phosphorus and Magnesium Download |
| Sep 21, 2020 | 1054 | petitioner | Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition, 63 Fed. Reg. 176 Download |
| Sep 21, 2020 | 1053 | petitioner | August 2017 Important Drug Warning Letter from Patent Owner to Health Care Provider Download |
| Sep 21, 2020 | 1048 | petitioner | Download |
| Sep 21, 2020 | 1047 | petitioner | Friedmann et al., CCLXV, Reactions of Pyruvic Acid with Thiolacetic Acid and Cysteine Download |
| Sep 21, 2020 | 1046 | petitioner | Clark., Effects of Two Different Doses of Amino Acid Supplementation on Growth and Blood Amino Acid Levels in Premature Neonates Admitted to the NICU Download |
| Sep 21, 2020 | 1045 | petitioner | Download |
| Sep 21, 2020 | 1044 | petitioner | Prescribing Information for Zinc Sulfate Injection (revised 07/2019) Download |
| Sep 21, 2020 | 1043 | petitioner | July 10, 2019 Press Release regarding Selenious Acid Injection Download |
| Sep 21, 2020 | 1042 | petitioner | Prescribing Information for Selenious Acid Injection (revised 04/2019) Download |
| Sep 21, 2020 | 1041 | petitioner | Connaughton, Argon or Nitrogen: Which is Best for Your Application? Download |
| Sep 21, 2020 | 1038 | petitioner | Lima-Rogel et al., Aluminum Contamination in Parenteral Nutrition Admixtures for Low-Birth-Weight Preterm Infants in Mexico Download |
| Sep 21, 2020 | 1037 | petitioner | Yu et al., Understanding Pharmaceutical Quality by Design Download |
| Sep 21, 2020 | 1036 | petitioner | Schuringa et al., The Reaction of Combined Cystine of Wool with Sodium Bisulfite Download |
| Sep 21, 2020 | 1035 | petitioner | Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition, 65 Fed. Reg. 4103 Download |
| Sep 21, 2020 | 1034 | petitioner | Teasdale, Impurities in New Drug Substances and New Drug Products: ICH Q3A/B: Key Guidelines in the General Impurity Management Process Download |
| Sep 21, 2020 | 1033 | petitioner | Zhu et al., Formulation of Protein- and Peptide-Based Parental Products Download |
| Sep 21, 2020 | 1032 | petitioner | Avallone, Food and Drug Administration Inspection and Licensing of Manufacturing Facilities Download |
| Sep 21, 2020 | 1031 | petitioner | Patel et al., Stability Considerations for Biopharmaceuticals, Part 1: Overview of Protein and Peptide Degradation Pathways Download |
| Sep 21, 2020 | 1030 | petitioner | Copyright Registration Number for Alpaslan Yaman, Engineering Considerations in Sterile Powder Processes Download |
| Sep 21, 2020 | 1029 | petitioner | Yaman, Engineering Considerations in Sterile Powder Processes Download |
| Sep 21, 2020 | 1028 | petitioner | Maget, Use of an Oxygen Extractor to Minimize Oxidation of Compounded Preparations Download |
| Sep 21, 2020 | 1027 | petitioner | Waterman et al., Stabilization of Pharmaceuticals to Oxidative Degradation Download |
| Sep 21, 2020 | 1026 | petitioner | Nicolet, Biochemistry by Analogy: The Sulfur of Cystine Download |
| Sep 21, 2020 | 1025 | petitioner | Rokushika et al., Radiolysis of Cystine in Aqueous Solution by Gamma Irradiation Download |
| Sep 21, 2020 | 1024 | petitioner | Asquith et al., The Photochemical Degradation of Cystine in Aqueous Solution in the Presence of Air, Download |
| Sep 21, 2020 | 1023 | petitioner | Sullivan, The Effect of Pyruvic Acid on the Estimation of Cystine and Cysteine Download |
| Sep 21, 2020 | 1022 | petitioner | Download |
| Sep 21, 2020 | 1021 | petitioner | ESSENTIALS OF PHARMACEUTICAL CHEMISTRY Download |
| Sep 21, 2020 | 1020 | petitioner | Allen, L-Cysteine Hydrochloride 50 mg/mL Injection Download |
| Sep 21, 2020 | 1019 | petitioner | August 4, 2017 Letter from Donna Griebel, M.D., CDER, to Patent Owner Download |
| Sep 21, 2020 | 1018 | petitioner | FDA GUIDANCE FOR INDUSTRY Q8(R2) PHARMACEUTICAL DEVELOPMENT (Nov. 2009) Download |
| Sep 21, 2020 | 1017 | petitioner | Rabinow, Plastic Packaging Materials, in REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY Download |
| Sep 21, 2020 | 1016 | petitioner | Cysteine, DRUGBANK Download |
| Sep 21, 2020 | 1015 | petitioner | Download |
| Sep 21, 2020 | 1014 | petitioner | Akers, Parenteral Preparations, in REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY Download |
| Sep 21, 2020 | 1013 | petitioner | Q3D ELEMENTAL IMPURITIES: GUIDANCE FOR INDUSTRY (Sept. 2015) Download |
| Sep 21, 2020 | 1012 | petitioner | Bohrer, Influence of the Glass Packing on the Contamination of Pharmaceutical Products by Aluminum. Part III Download |
| Sep 21, 2020 | 1011 | petitioner | Pilaniya, Recent Trends in the Impurity Profile of Pharmaceuticals Download |
| Sep 21, 2020 | 1008 | petitioner | Bohrer, Influence of the Glass Packing on the Contamination of Pharmaceutical Products by Aluminum. Part II Download |
| Sep 21, 2020 | 1007 | petitioner | Poole et al., Aluminum in Pediatric Parenteral Nutrition Products Download |
| Sep 21, 2020 | 1006 | petitioner | Download |
| Sep 21, 2020 | 1005 | petitioner | Way Back Machine Screenshots Download |
| Sep 21, 2020 | 1004 | petitioner | Affidavit of Christopher Butler Download |
| Sep 21, 2020 | 1003 | petitioner | Declaration of Barrett Rabinow, Ph.D. Download |
| Sep 21, 2020 | 1002 | petitioner | U.S. Patent No. 10,478,453 File History Download |
| Sep 21, 2020 | 1001 | petitioner | U.S. Patent No. 10,583,155 Download |
| Aug 4, 2021 | 15 | board | Notice of Refund Download |
| Jul 29, 2021 | 14 | petitioner | Petitioner's Request for Refund of Post-Institution Fee (PGR2020-00086 '719 Patent) Download |
| Jul 21, 2021 | 13 | board | Denying Petitioner's Request on Rehearing of Decision Denying Institution of Post Grant Review Download |
| May 5, 2021 | 12 | petitioner | Petitioner's Request for Rehearing Download |
| Apr 23, 2021 | 11 | board | Trial Instituted Document Download |
| Feb 25, 2021 | 10 | patent_own | Patent Owner's Sur-Reply to Petitioner's Reply to Patent Owner's Preliminary Response Download |
| Feb 17, 2021 | 9 | petitioner | Petitioner's Updated Index of Exhibits Download |
| Feb 17, 2021 | 8 | petitioner | Petitioner's Reply to Patent Owner's Preliminary Response Download |
| Feb 10, 2021 | 7 | petitioner | Petitioner's Updated index of Exhibits Download |
| Jan 27, 2021 | 6 | patent_own | Patent Owner Preliminary Response Download |
| Oct 27, 2020 | 5 | board | Notice of Accord Filing Date Download |
| Oct 5, 2020 | 4 | patent_own | Patent Owner's Power of Attorney Download |
| Oct 5, 2020 | 3 | patent_own | Patent Owner's Mandatory Notices Download |
| Sep 21, 2020 | 2 | petitioner | Petitioner's Power of Attorney Download |
| Sep 21, 2020 | 1 | petitioner | Petition for Post Grant Review of U.S. Patent No. 10,653,719 Download |
