Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals - PGR2025-00086

Petitioner's Opposition to Patent Owner's Discretionary Denial Request

Petitioner's Updated Exhibit List

The Opposition Division of the European Patent Office decision revoking EP2484822B1 with auxiliary requested claims

Petitioner’s Reply Brief, Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P., IPR2024-01197, Paper 20

Judgment Granting Request for Adverse Judgment after Institution of Trial, Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P., IPR2024-01197, Paper 41 (PTAB 2025)

2024-10-23 Transcript of Oral Hearing Dismissing Complaint, Ellodi Pharmaceuticals, L.P. v. Dr. Falk Pharma, Case No. 24-cv- 01392-PTG (E.D. Va)

Judgment Against Ellodi in Ellodi Pharmaceuticals, L.P. v. Dr. Falk Pharma GmbH, Case No. 4b O 43/24, Regional Court of Dusseldorf, Germany (Feb. 27, 2025) – Original German Language

Judgment Against Ellodi in Ellodi Pharmaceuticals, L.P. v. Dr. Falk Pharma GmbH, Case No. 4b O 43/24, Regional Court of Dusseldorf, Germany (Feb. 27, 2025) – Certified English Language Translation

PTAB email instructing Ellodi Pharmaceuticals that declaration evidence may not be submitted with Patent Owner’s Sur-reply, Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P., IPR2024- 01197, EX3003

Email exchange between PTAB and Ellodi Pharmaceuticals regarding improper exhibits submitted with Patent Owner’s Surreply, Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P IPR2024-01197, EX3004

Patent Owner’s Opposition To Petitioner’s Motion For Additional Discovery, Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P., IPR2025-00052, Paper 22

Patent Owner’s Opposition To Petitioner’s Motion For Additional Discovery, Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P., IPR2025-00054, Paper 23

Email exchange between PTAB and the Parties regarding additional discovery and false statement in Patent Owner Opposition brief, Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P., IPR2025- 00052 and IPR2025-00054, EX3001

Petitioner’s email to the Director regarding Patent Owner’s unauthorized request for Certificate of Correction, Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P., PGR2025-00086

Patent Owner’s Response, Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P., IPR2025-00052, Paper 15

Patent Owner’s Response, Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P., IPR2025-00054, Paper 16

Patent Owner’s Response, Dr. Falk Pharma GmbH v. Ellodi Pharmaceuticals, L.P., IPR2025-00055, Paper 15

Dellon, E.S. et al., Fluticasone Propionate Orally Disintegrating Tablet (APT-1011) for Eosinophilic Esophagitis: Randomized Controlled Trial, Clinical Gastroenterology and Hepatology 20:2485–2494 (2022)

Excerpt from the file history of U.S. Patent No. 10,632,069

Iorgulescu, G., Saliva between normal and pathological. Important factors in determining systemic and oral health, Journal of Medicine and Life Vol. 2, No.3, July-September 2009, pp.303-307

Miehkle, S. et al., A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic oesophagitis, Gut 0:1-10 (2015)

Curriculum Vitae of Martyn Christopher Davies

Clinical Trials Study, “Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE)(FLUTE),”

Transcript of the April 9, 2025 Deposition of Alan F. Parr, Pharm.D., Ph.D. from No. IPR2024-01197

“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)

Hahm, H.A., Augsburger, L.L., Ch. 9 Orally Disintegrating Tablets and Related Tablet Formulations

Hahm, H.A., Augsburger, L.L., Ch. 9 Orally Disintegrating Tablets and Related Tablet Formulations

Transcript of the August 25, 2025 deposition of Alan Parr, Pharm.D. from No. IPR2024-01197

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

Dr. Falk Pharma GMBH v. Ellodi Pharms., L.P., IPR2024-01197, EX1093 (P.T.A.B. July 10, 2024)

Highlights of Prescribing Information for EOHILIA™

Sonnegaard, J.M. et al., Comparative Investigations of Tablet Crushing Force Testers, Pharm. Ind. 67, Nr. 1, 109−115 (2005)

Dr. Schleuniger® Pharmatron Tablet Hardness Measuring Technology, Key Factors Influencing measured tablet hardness (2011)

USP <1151>, Pharmaceutical Dosage Forms

Declaration of Martyn Davies in Support of Patent Owner's Preliminary Response

Patent Owner's Preliminary Response

Order: Staying Certificate of Correction

Patent Owner's Brief in Support of Discretionary Denial

Request for Certificate of Correction for U.S. Patent No. 12,290,598

Notice: Mandatory Notice

Notice: Power of Attorney

Notice: NOTICE OF FILING DATE ACCORDED TO PETITION AND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE

U.S. Patent No. 12,290,598 to Perrett et al

U.S. Publication No. 20070111978 to Dohil et al.

FDA Guidance for Industry - Orally Disintegrating Tablets

FDA Draft Guidance for Industry on Orally Disintegrating Tablets (2007)

International Publication No. WO2000044351 to Grother et al.

Svoboda et al., Oral formulations of budesonide

Tan et al. Eosinophilic gastroenteritis treatment

Exhibit 1011 Kolkman et al.

Siewert et al. Digestive and Liver Disease

Budesonide for the Treatment of Obstructive Eosinophilic Jejunitis

Exhibit 1014 - Aceves et al.

Exhibit 1015 - Aceves et al.

Danckwerts, Intraoral Drug Delivery A Comparative Review

Fu et al., Orally fast disintegrating tablets

Shukla et al., Mouth Dissolving Tablets

U.S. Patent Publication No. 2005_0232988A1

Goodman And Gillman's

Budenofalk Brochure 2005

Budenofalk Advertisement 2007

Dr Falk Pharma Brochure (2008)

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

Prosecution history excerpts from U.S. Application No.12896005

Eosinophilic esophagitis in children

Exhibit 1034 - Noel et al.

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

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

USP Convention 701 Disintegration, Revision Bulletin August 1, 2008

Conway Solid Dosage Forms

Exhibit 1047 El-Arini et al.

Exhibit 1064 - Roeder et al.,

Exhibit 1065 - Remedios et al.

Exhibit 1066 - Konikoff et al.

Prosecution history excerpts from U.S. Application No. 17/569,047

U.S. Application No. 17/569,047 as filed on January 5, 2022

U.S. Application No. 16/821,464 as filed on March 17, 2020

U.S. Application No. 15/816,154 as filed on November 17, 2017

U.S. Application No. 15/205,390 as filed on July 8, 2016

U.S. Application No. 14/311,732 as filed on June 23, 2014

U.S. Application No. 12/896,005 as filed on October 1, 2010

U.S. Provisional Application No. 61/247,642 as filed on October 1, 2009

The United States Pharmacopeia, USP 31, 2008 (“USP”)

The European Pharmacopeia, 6.0, 2008

Remington: The science and practice of pharmacy, 20th edition

Lee, “Pharmaceutical Preformulation,”

Seitz et al., “Evaluation of the physical properties of compressed tablets

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

International Publication No. WO2002015884 to Kararli et al. (“Kararli”)

International Publication No. WO2009006516 "Venkatesh516"

International Publication No. WO2010127345 “Venkatesh345"

International Publication No. WO2010127346 “Venkatesh346"

Declaration of Alan F. Parr, Pharm.D., Ph.D. supporting PGR petition of U.S

Petition: as filed

Notice: Power of Attorney