Eton Pharmaceuticals Inc. vs Exela Pharma Sciences, LLC

Notice of Refund

Petitioner's Request for Refund of Post-Institution Fee (PGR2020-00068 '155 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

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. 16/746,028 ¿¿¿ 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)

Petitioner's Reply to Patent Owner's Preliminary Response

Petitioner's Updated Index of Exhibits

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)

Excerpt From the File History of Pending Application No. 16/773,641 ¿¿¿ Request for Continued Examination (June 2, 2020) and Information Disclosure Statement (June 11, 2020)

Excerpt From the File History of Pending Application No. 16/773,641 ¿¿¿ Non-Final Rejection (July 23, 2020)

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

ORDER Conduct of Proceeding 37 C.F.R. ¿¿¿¿ 42.5; 42.208(c)

Ex. 3001

Declaration of Dr. Robert J. Kuhn

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

Patent Owner's Preliminary Response

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

Jay M. Mirtallo, Aluminum Contamination of Parenteral Nutrition Fluids

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

Robert L. Poole et al., Aluminum Exposure From Pediatric Parenteral Nutrition

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

Notice of Accord Filing Date

Patent Owner's Mandatory Notices

Patent Owner Power of Attorney

Petitioner's Power of Attorney

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

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

Petition for Post Grant Review of U.S. Patent No. 10,583,155

Affidavit of Christopher Butler

Declaration of Barrett Rabinow, Ph.D.

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

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

Way Back Machine Screenshots re Hospira

Affidavit of Christopher Butler

Michael J Akers, Parenteral Preparations

Cysteine, DRUGBANK, https://www.drugbank.ca/drugs/

Barrett E. Rabinow et al., Plastic Packaging Materials,

Way Back Machine Screenshots re Sandoz

Robert L. Poole et al., Aluminum in Pediatric Parenteral Nutrition Products: Measured Versus Labeled Content

Kavita Pilaniya et al., Recent Trends in the Impurity Profile of Pharmaceuticals

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

3D ELEMENTAL IMPURITIES: GUIDANCE FOR INDUSTRY

Winston W.K. Koo et al., Aluminum in Parenteral Nutrition Solution¿¿¿ Sources and Possible Alternatives

FDA GUIDANCE FOR INDUSTRY Q8(R2) PHARMACEUTICAL DEVELOPMENT

August 4, 2017 Letter from Donna Griebel, M.D.

Loyd V. Allen, L-Cysteine Hydrochloride 50 mg/mL Injection

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

Ben H. Nicolet, Biochemistry by Analogy: The Sulfur of Cystine

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

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

ESSENTIALS OF PHARMACEUTICAL CHEMISTRY

Declaration of Harry ¿¿¿Warren¿¿¿ Johnson

M.X. Sullivan et al., The Effect of Pyruvic Acid on the Estimation of Cystine and Cysteine

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

Kenneth C. Waterman et al., Stabilization of Pharmaceuticals to Oxidative Degradation

Henri J. R. Maget, Use of an Oxygen Extractor to Minimize Oxidation of Compounded Preparations

Alpaslan Yaman, Engineering Considerations in Sterile Powder Processes

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

Henry L. Avallone et al., Food and Drug Administration Inspection and Licensing of Manufacturing Facilities

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

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

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

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

Ulrich Reichert et al., Metal Residue: How Much is Too Much?

Diane L. Tribble et al., Hypercysteinemia and Delayed Sulfur Excretion in Cirrhotics After Oral Cysteine Loads

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

Prescribing Information for Selenious Acid Injection

Prescribing Information for Zinc Sulfate Injection

Reese H. Clark et al., Effects of Two Different Doses of Amino Acid Supplementation on Growth and Blood Amino Acid Levels in Premature Neonates

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

Maaike A. Riedijk et al., Cysteine: A Conditionally Essential Amino Acid In Low-Birth-Weight Preterm Infants?,

A. D. Patrick, The Degradative Metabolism of L-Cysteine and L-Cystine In Vitro By Liver in Cystinosis

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

Dayong Luo et al., Kinetics and Mechanism of the Reaction of Cysteine and Hydrogen Peroxide in Aqueous Solution,

Lawrence X. Yu et al., Understanding Pharmaceutical Quality by Design

July 10, 2019 Press Release regarding Selenious Acid Injection

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

U.S. Patent No. 8,415,337

Soghier LM et al., CYSTEINE, CYSTINE OR N-ACETYLCYSTEINE SUPPLEMENTATION IN PARENTERALLY FED NEONATES (REVIEW), COCHRANE DATABASE OF SYSTEMATIC REVIEWS

Screenshot of https://www.rxlist.com/aminosyn-sulfite-free-drug.htm

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

E. S. Guzman Barron, Thiol Groups of Biological Importance

Daniel Rudman et al., Hypotyrosinemia, Hypocystinemia, and Failure to Retain Nitrogen During Total Parenteral Nutrition of Cirrhotic Patients

Len 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

Arika Hanaki, et al., Manometric Study of the Copper-Catalyzed Oxidation of Cysteine,

Walter D. Block et al., Methionine, Cysteine, Cystine, and Taurine Interrelationships in Human Plasma

Mary Fewtrell et al., Symposium 2: Micronutrients Under the Microscope Aluminium Exposure From Parenteral Nutrition

U.S. Patent No. 6,382,442

21 C.F.R. ¿¿ 201.323

Copyright Registration Number for DRUG FACTS AND COMPARISONS (2015)

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

Charles J. J. Fox, On the Coefficients of Absorption of Nitrogen and Oxygen in Distilled Water and Sea-Water and of Atmospheric Carbonic Acid in Sea-Water

STANDARD METHODS FOR THE EXAMINATION OF WATER AND SEWAGE, APHA

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

Michael L. McHalsky, et al., Reduction of Aluminum Levels in Dialysis Fluids Through the Development and Use of Accurate and Sensitive Analytical Methodology

Barrett E. Rabinow et al., Aluminum in Parenteral Products: Analysis, Reduction and Implications for Pediatric TPN,

George C. Whipple et al., Solubility of Oxygen in Sea Water

Orange Book Screenshot for Elcys

DRUG FACTS AND COMPARISONS (2015)

Declaration of Daniel Ingles

R.C. Whiting et al., Effect of Headspace Oxygen Concentration on Growth and Toxin Production by Proteolytic Strains of Clostridium Botulinum

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

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

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

Johannes B. van Goudoever et al., ESPGHAN/ESPEN/ESPR/CSPEN Guidelines on Pediatric Parenteral Nutrition: Amino Acids

Declaration of Madan Chilakuri

Michael H. Malloy et al., Total Parenteral Nutrition in Sick Preterm Infants

Terhi Ahola et al., N-Acetylcysteine Does Not Prevent Bronchopulmonary Dysplasia in Immature Infants

Stanley H. Zlotkin, et al., Cysteine Supplementation to Cysteine-free Intravenous Feeding Regimens in Newborn Infants

GUIDANCE FOR INDUSTRY: E11 CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION (Dec. 2000)

THE UNITED STATES PHARMACOPEIA ¿¿¿ THE NATIONAL FORMULARY, (1985)

Joseph Boullata, Nutrients and Associated Substances

Yakup Yesil et al., Evaluation of the Children with Acute Acetaminophen Overdose and Intravenous N-Acetylcysteine Treatment

Farideh Jalilehvand et al., Lead(II) Complex Formation with L-Cysteine in Aqueous Solution

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

Jay Mirtallo et. al., Safe Practices for Parenteral Nutrition,

Michael C. Storm et al., Cysteine Supplementation Normalizes Plasma Taurine Concentrations in Low Birth Weight Premature Infants

Letter from Baxter Healthcare Corp. to Healthcare Professional, dated November 30, 2017

Ekhard E. Zeigler, Parenteral Nutrition¿¿ in IOWA NEONATOLOGY HANDBOOK (2006)

Patricia Worthington et al., When is Parenteral Nutrition Appropriate?

Emily Gasser et al., Parenteral Nutrition: Macronutrient Composition and Requirements

Determination that Cysteine Hydrochloride Injection, USP, 7.25%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 75 Fed. Reg. 31,790

May 8, 2018 Citizen Petition regarding Cysteine Hydrochloride Injection 5% and Attachments

BENTLEY¿¿¿S TEXTBOOK OF PHARMACEUTICALS: AN ADAPTATION

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

WM Lee et al., Intravenous N-Acetylcysteine Improves Transplant-Free Survival in Early Stage Non-Acetaminophen Acute Liver Failure

Shadi S. Yarandi et al., Amino Acid Composition in Parenteral Nutrition: What is the Evidence

Declaration of Judy He