Eton Pharmaceuticals, Inc. vs Exela Pharma Sciences, LLC

Notice of Refund

Petitioner's Request for Refund of Post-Institution Fee (PGR2020-00064 '453 Patent)

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

Petitioner's Request for Rehearing

Trial Instituted Document

U.S. Patent 4,385,086 (Nakayama)

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

Petitioner's Reply to Patent Owner's Preliminary Response

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. 16/746,028 ¿¿¿ 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 ¿¿¿ Information Disclosure Statement (April 17, 2020)

Petitioner's Updated Index of Exhibits

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. 16/773,641 ¿¿¿ Request for Continued Examination (June 2, 2020) and Information Disclosure Statement (June 11, 2020)

Excerpt From the File History of Pending Application No. 16/746,028 ¿¿¿ 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)

Declaration of John Geissler, Ex 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 Updated Index of Exhibits

Transcript of Conference call with Board on September 21, 2020

Order - Conduct of the Proceeding - 37 CFR 42.5; 42.08(c)

Patent Owner Preliminary Response

Aileen B. Sedman - Evidence of Aluminum Loading in Infants Receiving Intravenous Therapy

Nicholas J. Bishop - 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., No. 1:20-cv-00645-MN (D. Del. June 1, 2020)

Amended Complaint, Exela Pharma Sciences, LLC v. Eton Pharmaceuticals, Inc., No. 20-365-MN (D. Del. July 28, 2020)

Megan Fortenberry - Evaluating Differences in Aluminum Exposure Through Parenteral Nutrition in Neonatal Morbidities

Gordon L. Klein - Hypocalcemia Complicating Deferoxamine Therapy

Declaration of Dr. Robert J. Kuhn

Declaration of Mark Hartman (Redacted), Exela Pharma Sciences, LLC v. Sandoz Inc., No. 19-cv-00318-MR

Kathleen M. Gura, Aluminum Contamination in Parenteral Products

Jay M. Mirtallo, Aluminum Contamination of Parenteral Nutrition Fluids

Robert L. Poole - Aluminum Exposure From Pediatric Parenteral Nutrition - Meeting the New FDA Regulation

Notice of Accord Filing Date

Patent Owner's Mandatory Notices

Patent Owner Power of Attorney

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

Declaration of Barrett Rabinow, Ph.D.

Way Back Machine Screenshots (Sandoz)

Robert L. Poole et al., Aluminum in Pediatric Parenteral Nutrition Products

Way Back Machine Screenshots (Hospira)

Affidavit of Christopher Butler

Petition for Post Grant Review

Petitioner's Power of Attorney

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

Affidavit of Christopher Butler

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

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

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

FDA GUIDANCE FOR INDUSTRY Q8(R2)

August 4, 2017 Letter from Donna Griebel, M.D., Director of Division of Gastroenterology and Inborn Errors Products, CDER, to Patent Owner

ESSENTIALS OF PHARMACEUTICAL CHEMISTRY

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

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

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

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,

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

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

July 10, 2019 Press Release regarding Selenious Acid Injection

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

Q3D ELEMENTAL IMPURITIES: GUIDANCE FOR INDUSTRY

Michael J Akers, Parenteral Preparations

Cysteine, DRUGBANK

Barrett E. Rabinow et al., Plastic Packaging Materials

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

Declaration of Harry ¿¿¿Warren¿¿¿ Johnson

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

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

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

Jalpa Patel et al., Stability Considerations for Biopharmaceuticals, Part 1

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

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 (revised 04/2019)

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

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

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

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,

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

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

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

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

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

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

Orange Book Screenshot for Elcys

DRUG FACTS AND COMPARISONS (2015)

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

Eton Pharmaceuticals, Inc.¿¿¿s May 6, 2020 Answer and Affirmative Defenses to Complaint

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

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

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

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

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

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

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

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

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

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

STANDARD METHODS FOR THE EXAMINATION OF WATER AND SEWAGE,

21 C.F.R. ¿¿ 201.323

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

Copyright Registration Number for 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,

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