Dr. Falk Pharma GMBH vs Ellodi Pharmaceuticals LP - IPR2025-00054

Petitioner's Objections to Admissibility of Patent Owner's Evidence

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

Transcript of the August 29, 2025 Deposition of Alan F. Parr, Pharm.D., Ph.D. from Nos. IPR2025-00052, IPR2025-00054, and IPR2025-00055

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

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

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)

Hahm, H.A., Augsburger, L.L., 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. from No. IPR2024-01197

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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

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

Transcript from the July 2, 2025 Deposition of Martyn Christopher Davies, Ph.D. from No. IPR2024-01197

U.S. Patent 9,867,780

Geoffrey Lee, Report on Measurement of Disintegration Time of Jorveza® 1 mg Schmelztabletten

Jorveza® label

Patent Owner's Response

Patent Owner's Updated Mandatory Notices

Patent Owner's Notice of Intent to Designate I. Agarwal as Backup Counsel

Patent Owner's Exhibit List

Agarwal Declaration

Joint Stipulation to Modify Due Dates 1-3

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

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

Institution Decision: DECISION Granting Institution of Inter Partes Review 35 U.S.C. § 314

Order: SCHEDULING ORDER

Petitioner's Supplmental Mandatory Notice

Notice: Notice filing date accorded

Notice : Mandatory Notice

Notice : Power of Attorney

U.S. Patent No. 11,246,828

U.S. Publication No. 20070111978

EP2482822B1

The Opposition Division of the European Patent Office decision revoking EP2

FDA Guidance for Industry - Orally Disintegrating Tablets

Notice of Publication of FDA Guidance for Industry on Orally Disintegrating

Notice of Publication of FDA Guidance for Industry on Orally Disintegrating

WO2000044351A1

Oral formulations of budesonide a novel treatment for inflammatory bowel

Eosinophilic gastroenteritis treated with non-enteric-coated budesonide tab

Evaluation of oral budesonide in the treatment of active distal ulcerative

Eosinophilic gastroenteritis with severe protein-losing enteropathy Succes

Budesonide for the treatment of obstructive eosinophilic jejunitis

Topical viscous budesonide suspension for treatment of eosinophilic esophag

Oral Viscous Budesonide_ A potential new therapy for eosinophilic esophagit

The United States Pharmacopeia, USP 32

Intraoral Drug Delivery_ A Comparative Review

Orally fast disintegrating tablets developments, technologies, taste-mask

Mouth Dissolving Tablets I An overview of formulation technology, Scientia

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

Prosecution History excerpts 12896005

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

U.S. Patent No. 7,229,641

Prosecution history excerpts from U.S. Application No. 17_236,295

DisintegrationRevisedBulletin2008

Conway Solid Dosage Forms

Handbook of Pharmaceutical Excipients 5th Edition - Magnesium Stearate

Handbook of Pharmaceutical Excipients 5th Edition - Mannitol

Handbook of Pharmaceutical Excipients 5th Edition - Povidone

Handbook of Pharmaceutical Excipients 5th Edition - Sucralose

Handbook of Pharmaceutical Polyethylene

El-Arini 2002

File History Excerpts US10632069

File History Excerpts US11246828

Parr Declaration 828 patent

US Pat 10,632,069

Petition : as filed

Notice : Power of Attorney

[CORRECTED] Handbook of Pharmaceutical Excipients 5th Edition - Sucralose

Corrected Certificate of Service