Eton Pharmaceuticals, Inc. vs Exela Pharma Sciences LLC

Notice of Refund

Petitioner's Request for Refund of Post-Institution Fee (PGR2020-00086 '719 Patent)

Denying Petitioner's Request on Rehearing of Decision Denying Institution of Post Grant Review

Petitioner's Request for Rehearing

Trial Instituted Document

Patent Owner's Sur-Reply to Petitioner's Reply to Patent Owner's Preliminary Response

Petitioner's Reply to Patent Owner's Preliminary Response

Petitioner's Updated Index of Exhibits

Eton���s Request for Rehearing (PGR2020-00064, Paper 13)

Eton���s Request for Rehearing (PGR2020-00068, Paper 12)

Petitioner's Updated index of Exhibits

Transcript of Conference Call with Board taken February 8, 2021

Patent Owner Preliminary Response

Declaration of Dr. Robert J. Kuhn

Aileen B. Sedman et al., Evidence of Aluminum Loading in Infants Receiving Intravenous Therapy

Nicholas J. Bishop et al., Aluminum Neurotoxicity in Preterm Infants Receiving Intravenous-Feeding Solutions

ELCYS Label, Exela Pharma Sciences, LLC

Amended Complaint (Redacted), Exela Pharma Sciences, LLC v. Sandoz, Inc.

Amended Complaint, Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc.

Declaration of Mark Hartman (Redacted), Exela Pharma Sciences, LLC v. Sandoz Inc.

Megan Fortenberry et al., Evaluating Differences in Aluminum Exposure Through Parenteral Nutrition in Neonatal Morbidities

Kathleen M. Gura, Aluminum Contamination in Parenteral Products

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

Jay M. Mirtallo, Aluminum Contamination of Parenteral Nutrition Fluids

Robert L. Poole et al., Aluminum Exposure From Pediatric Parenteral Nutrition: Meeting the New FDA Regulation

Eton Pharmaceuticals, Inc., Amendment No. 1 to Sales/Marketing Agreement

Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, Inc., PGR2020-00064, Paper 1

Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, Inc., PGR2020-00064, Paper 12

Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, Inc., PGR2020-00068, Paper 1

Eton Pharmaceuticals, Inc. v. Exela Pharma Sciences, Inc., PGR2020-00068, Paper 11

Eton Letter to Judge Noreika, Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc.

Excerpt From the File History of U.S. Patent Application No. 16/746,028

Excerpt From the File History of U.S. Patent Application No. 16/773,641

Opening Brief in Support of Defendant Eton Pharmaceuticals, Inc.���s Motion to Stay Pending Post-Grant Proceedings, Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc.

Notice of Accord Filing Date

Patent Owner's Power of Attorney

Patent Owner's Mandatory Notices

Petition for Post Grant Review of U.S. Patent No. 10,653,719

U.S. Patent No. 10,583,155

Way Back Machine Screenshots

Poole et al., Aluminum in Pediatric Parenteral Nutrition Products

Bohrer, Influence of the Glass Packing on the Contamination of Pharmaceutical Products by Aluminum. Part II

Pilaniya, Recent Trends in the Impurity Profile of Pharmaceuticals

Bohrer, Influence of the Glass Packing on the Contamination of Pharmaceutical Products by Aluminum. Part III

Q3D ELEMENTAL IMPURITIES: GUIDANCE FOR INDUSTRY (Sept. 2015)

Akers, Parenteral Preparations, in REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY

Koo, Aluminum in Parenteral Nutrition Solution¿¿¿ Sources and Possible Alternatives

Petitioner's Power of Attorney

U.S. Patent No. 10,478,453 File History

Declaration of Barrett Rabinow, Ph.D.

Affidavit of Christopher Butler

Hern¿¿ndez-S¿¿nchez et al., Aluminum in Parenteral Nutrition: A Systematic Review,

Cysteine, DRUGBANK

Rabinow, Plastic Packaging Materials, in REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY

Declaration of Harry ¿¿¿Warren¿¿¿ Johnson, dated May 15, 2020

Asquith et al., The Photochemical Degradation of Cystine in Aqueous Solution in the Presence of Air,

FDA GUIDANCE FOR INDUSTRY Q8(R2) PHARMACEUTICAL DEVELOPMENT (Nov. 2009)

August 4, 2017 Letter from Donna Griebel, M.D., CDER, to Patent Owner

Allen, L-Cysteine Hydrochloride 50 mg/mL Injection

ESSENTIALS OF PHARMACEUTICAL CHEMISTRY

Sullivan, The Effect of Pyruvic Acid on the Estimation of Cystine and Cysteine

Rokushika et al., Radiolysis of Cystine in Aqueous Solution by Gamma Irradiation

Nicolet, Biochemistry by Analogy: The Sulfur of Cystine

Waterman et al., Stabilization of Pharmaceuticals to Oxidative Degradation

Maget, Use of an Oxygen Extractor to Minimize Oxidation of Compounded Preparations

Copyright Registration Number for Alpaslan Yaman, Engineering Considerations in Sterile Powder Processes

Patel et al., Stability Considerations for Biopharmaceuticals, Part 1: Overview of Protein and Peptide Degradation Pathways

Yaman, Engineering Considerations in Sterile Powder Processes

Avallone, Food and Drug Administration Inspection and Licensing of Manufacturing Facilities

Zhu et al., Formulation of Protein- and Peptide-Based Parental Products

Teasdale, Impurities in New Drug Substances and New Drug Products: ICH Q3A/B: Key Guidelines in the General Impurity Management Process

Schuringa et al., The Reaction of Combined Cystine of Wool with Sodium Bisulfite

Yu et al., Understanding Pharmaceutical Quality by Design

July 10, 2019 Press Release regarding Selenious Acid Injection

Prescribing Information for Zinc Sulfate Injection (revised 07/2019)

UCSF CHILDREN¿¿¿S HOSPITAL INTENSIVE CARE NURSERY HOUSE STAFF MANUAL (2004-2006)

U.S. Patent No. 8,415,337 (¿¿¿¿¿¿337 patent¿¿¿)

Mihatsch, ESPGHAN/ESPEN/ESPR/ESPEN Guidelines on Pediatric Parenteral Nutrition: Calcium, Phosphorus and Magnesium

Luo, Kinetics and Mechanism of the Reaction of Cysteine and Hydrogen Peroxide in Aqueous Solution

Hanaki, Manometric Study of the Copper-Catalyzed Oxidation of Cysteine

Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition, 65 Fed. Reg. 4103

Lima-Rogel et al., Aluminum Contamination in Parenteral Nutrition Admixtures for Low-Birth-Weight Preterm Infants in Mexico

Connaughton, Argon or Nitrogen: Which is Best for Your Application?

Prescribing Information for Selenious Acid Injection (revised 04/2019)

Clark., Effects of Two Different Doses of Amino Acid Supplementation on Growth and Blood Amino Acid Levels in Premature Neonates Admitted to the NICU

Friedmann et al., CCLXV, Reactions of Pyruvic Acid with Thiolacetic Acid and Cysteine

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

CDER ¿¿¿ NON-CLINICAL REVIEW(S), APP. NO. 210906ORIG1S000

Guzman Barron, Thiol Groups of Biological Importance

21 C.F.R. ¿¿ 201.323

Kasaraian et al., Developing an Injectable Formula Containing an Oxygen-Sensitive Drug

Okabe, Studies on the Solubility of Cystine Under Various Conditions, and On A New Method of Cystine Preparation

QUALITY BY DESIGN (QBD) APPROACHES FOR ORALLY INHALED AND NASAL DRUG PRODUCTS (OINDPS) IN THE USA, RDD EUROPE (2007)

Orange Book Screenshot for Elcys

DRUG FACTS AND COMPARISONS (2015)

Copyright Registration Number for DRUG FACTS AND COMPARISONS (2015)

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 (D. Del.)

SIGMA ALDRICH PRODUCT INFORMATION, L-CYSTEINE HYDROCHLORIDE MONOHYDRATE (05/06)

Whiting, Effect of Headspace Oxygen Concentration on Growth and Toxin Production by Proteolytic Strains of Clostridium Botulinum

Jalilehvand, Lead(II) Complex Formation with L-Cysteine in Aqueous Solution

BENTLEY¿¿¿S TEXTBOOK OF PHARMACEUTICALS: AN ADAPTATION

U.S. Patent No. 10,654,719

McHalsky, Reduction of Aluminum Levels in Dialysis Fluids

Rabinow, Aluminum in Parenteral Products: Analysis, Reduction and Implications for Pediatric TPN

USP 32/NF 18, The U.S. Pharmacopeial Convention (1995)

Declaration of Daniel Ingles

Butler et al., Removal of Dissolved Oxygen From Water: A Comparison of Four Common Techniques

U.S. Patent No. 10,478,453

U.S. Patent No. 10,654,719 File History

Langille, Particulate Matter in Injectable Drug Products

Akers, STERILE DRUG PRODUCTS: FORMULATION, PACKAGING, MANUFACTURING, AND QUALITY

USP 32/NF 27 (The U.S. Pharmacopeial Convention, 2009)

FDA Warning Letter to Mr. Ian Reed, Pfizer, dated February 14, 2017

August 26, 2020 Scheduling Order in Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., No. 20-00365-MN (D. Del.)

U.S. Patent No. 9,220,700

U.S. Patent No. 4,385,086

Turco, Intravenous Admixtures

Rignall, ICHQ1A(R2) Stability Testing of New Drug Substance and Product and ICHQ1C Stability Testing of New Dosage Forms

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

Stability Studies, in HANDBOOK OF MODERN PHARMACEUTICAL ANALYSIS

Declaration of Harry ¿¿¿Warren¿¿¿ Johnson, dated August 24, 2020

Q1A(R2) STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS

THE MERCK INDEX: AN ENCYCLOPEDIA OF CHEMICALS, DRUGS, AND BIOLOGICALS (2006)

July 23, 2020 Office Action in Application No. 16/746,028

July 23, 2020 Office Action in Application No. 16/773,641