DR. FALK PHARMA GMBH vs Ellodi Pharmaceuticals LP - IPR2024-01197

Petitioner's Request for Oral Argument

Patent Owner's Request for Oral Hearing

Petitioner's Opposition to Patent Owner's Motion to Strike

Ex. 3004

Patent Owner's Corrected Surreply

Patent Owner's Surreply

Hahm, HA, Augsberger, LL, Ch 9 Orally Disintegrating Tablets and Related Tablet Formulations

Ghosh, T.K. et al, Drug Delivery to the Oral Cavity Molecules to Market, Ch. 14 Quick dissolving oral dosage forms: Scientific and regulatory considerations from a clinical pharmacology and Biopharmaceutics Perspective (2005)

Transcript of the August 25, 2025 deposition of Alan Parr, Pharm.D.

Cordova-Fraga T, Sosa M, Wiechers C, et al., Effects of anatomical position on esophageal transit time: a biomagnetic diagnostic technique. World J Gastroenterol 14:5707–11 (2008)

U.S. Patent No. 8,324,192

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, Patent and Exclusivity for: N213976, Product 001 Budesonide (Eohilia) Suspension 2mg/10ml

Memorandum from Director Coke Morgan Stewart to Members of the Patent Trial and Appeal Board re Enforcement and Non-Waiver of 37 C.F.R. § 42.104(B)(4) and Permissible Uses of General Knowledge in Inter Partes Reviews, dated July 31, 2025

Guidance for Industry, Dissolution Testing of Immediate Release Solid Oral Dosage Forms, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (August 1997)

International Publication No. WO 2009/006516 A1

Patent Owner's Motion to Strike Exhibits 1075-1082, Portions of Petitioner’s Reply Brief and Dr. Parr’s Reply Declaration

Petitioner's Updated Exhibit List

August 14, 2025 Oral Hearing Transcript Regarding Patent Owner Request for Authorization to File a Motion to Strike in IPR2024- 01197

Ex. 3003

Joint Stipulation to Modify Due Date 3

Patent Owner's Notice of Deposition of Alan F. Parr, Pharm.D., Ph.D.

Patent Owner's Objections to Petitioner's Evidence Submitted with Petitioner Reply

Petitioner's Reply Brief

Petitioner's Updated Exhibit List

U.S. Publication No. US20110189299 to Okubo and Davies et al.

2025-07-02 Deposition transcript of Dr. Martyn Davies

Schoepfer et al., “Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults With Eosinophilic Esophagitis,” Clinical Gastroenterology and Hepatology, 17:1477- 1488 (2019)

2021-04-19 Assignment of U.S. Patent No. 8,771,729 from Adare Pharmaceuticals US, L.P. to Ellodi Pharmaceuticals, L.P. recorded at Reel 055966, Frame 0658

International Publication No. WO2003074029 to McEntee et al.

International Publication No. WO2009078872 to Martin et al.

U.S. Patent Publication No. 20030124184 to Mezaache et al.

U.S. Patent Publication No. 20050019393 to Augsburger et al.

U.S. Patent No. 7,384,921 to Tang et al.

U.S. Patent Publication No. 20080132535 to Singh et al.

U.S. Patent Publication No. 20090022799 to Barman

Than, “Individualized Drugs for Individual Needs,” Review of Optometry, 146:38-43 (2009)

Iorgulescu, “Saliva between normal and pathological. Important factors in determining systemic and oral health,” Journal of Medicine and Life 2:3003-307 (2009)

2015-09-18 Assignment of U.S. Patent Application No. 10/827,106 (which published as Venkatesh, EX1020) to Adare Pharmaceuticals, Inc. recorded at Reel 036554, Frame 0829

U.S. Patent No. 6,139,865 to Friend et al.

2015-09-18 Assignment of U.S. Patent No. 6,139,865 to Adare Pharmaceuticals, Inc. recorded at Reel 036640, Frame 0591

Narmada et al., “Formulation, evaluation and optimization of fast dissolving tablets containing amlodipine besylate by sublimation method,” ARS Pharmaceutica, 50:129-144 (2009)

Khan et al., “Taste masking of ondansetron hydrochloride by polymer carrier system and formulation of rapid-disintegrating tablets,” AAPS PharmSciTech 8:E1-E7 (2007)

CLARITIN® (loratadine) FDA-approved package insert

ZOFRAN® (ondansetron) FDA-approved package insert

CLARINEX® (desloratadine) FDA-approved package insert

PEPCID® (famotidine) FDA-approved package insert

Declaration of Alan F. Parr, Pharm.D., Ph.D. supporting Petitioner Reply for U.S. 8,771,729

Petitioner's Notice of Deposition of Dr. Martyn Christopher Davies

Patent Owner's Response

Declaration of Martyn Christopher Davies in Support of Patent Owner’s Response

Curriculum Vitae of Martyn Christopher Davies

U.S. Patent Application Publication No. 2005/0009848 A1

Clinical Trials Study, “Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)(FLUTE),” last updated Apr. 26, 2023

Deposition of Alan F. Parr, Pharm.D., Ph.D., dated April 9, 2025

“Antrum” Definition, American Medical Dictionary: A Concise and Up-to-Date Guide to Medical Terms (1998)

M.E. Aulton (Ed.), Pharmaceutics: The Science of Dosage Form Design (2d. 2002)

“Lozenge” Definition, Dennis B. Worthen (ed.), Dictionary of Pharmacy (2004)

Paul J. Sheskey et al., Handbook of Pharmaceutical Excipients (8d. 2017)

Panel Change Order

Granting Patent Owner’s Motion for Admission Pro Hac Vice of Isha Agarwal 37 C.F.R. § 42.10

Patent Owner's Notice of Deposition of Alan F. Parr, Pharm.D, Ph.D.

Patent Owner's Unopposed Motion for Pro Hac Vice Admission for Isha Agarwal

Patent Owner's Updated Exhibit List

Biography of Isha Agarwal

Declaration of Isha Agarwal ISO Motion for Pro Hac Vice Admission

Patent Owner's Objections Pursuant to 37 CFR 42.64(b)(1)

Institution Decision: Grant

SCHEDULING ORDER

Patent Owner's SurReply

Petitioner's Reply to Patent Owner's Preliminary Response

Petitioner's Supplemental Mandatory Notice Adding to the Related Matters Section

Exhibit 3002

Patent Owner's Preliminary Response

US Pat. Appl. Publ. No. US 2009/0191275 A1 to Dohil et al.

US Pat. Appl. Publ. No. US 2009/0169620 A1 to Venkatesh et al.

US Pat. Appl. Publ. No. US 2009/0131386 A1 to Phillips

Prosecution History for US Pat. No. 10,632,069

Exhibit 3001

Notice : Mandatory Notice

Notice : Power of Attorney

Notice: Notice filing date accorded

[Corrected] U.S. Patent Publication No. 20070111978

U.S. Patent No. 8,771,729 to Perrett et al.

EXPUNGED

EP2482822B1 that was revoked by the European Patent Office

The Opposition Division of the European Patent Office decision revoking

Guidance for Industry: Orally Disintegrating Tablets,” U.S. Food & Drug

Notice of Publication of FDA Guidance for Industry on Orally Disintegrating

DRAFT Guidance for Industry: Orally Disintegrating Tablets,

International Publication No. WO2000044351 to Grother et al.

Svoboda et al., “Oral formulations of budesonide: a novel treatment

Tan et al., “Eosinophilic gastroenteritis treated with non-enteric-coated

Kolkman et al., “Evaluation of oral budesonide in the treatment of active

Siewert et al., “Eosinophilic gastroenteritis with severe protein-losing

Elsing et al., “Budesonide for the treatment of obstructive eosinophilic

Aceves et al., “Topical viscous budesonide suspension for treatment

Aceves et al., “Oral Viscous Budesonide: A potential new therapy

The United States Pharmacopeia, USP 32, 2009 at pages 262-263

Danckwerts, “Intraoral Drug Delivery: A Comparative Review,” American

Fu et al., “Orally fast disintegrating tablets: developments, technologies

Shukla et al., “Mouth Dissolving Tablets I: An overview of formulation

U.S. Publication No. 20050232988 to Venkatesh et al.

Goodman & Gilman’s: The Pharmacological Basis of Therapeutics

Budenofalk Brochure (2005)

Budenofalk® Advertisement (2007)

Dr. Falk Pharma Brochure (2008)

Curriculum Vitae of Alan F. Parr, Pharm.D., Ph.D.

Declaration of Alan F. Parr, Pharm.D., Ph.D.

Prosecution history excerpts from U.S. Application No. 12/896,005

Prosecution history excerpts from U.S. Application No. 15/816,154

Teitlebaum et al., Eosinophilic esophagitis in children

Noel et al., “Clinical and immunopathologic effects of swallowed fluticason

U.S. Patent No. 7,122,198 to Singh et al.

U.S. Patent No. 7,229,641 Cherukuri et al.

Ellodi Response to the Grounds of Opposition filed by Dr. Falk Pharma GmbH

Prosecution history excerpts from U.S. Application No. 17/236,295

Notice : Power of Attorney

Petition : as filed