Dr. Falk Pharma GmbH vs Ellodi Pharmaceuticals LP - IPR2025-00055

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

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

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

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

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)

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

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

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

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

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: Granting Institution of Inter Partes Review 35 U.S.C. sec. 314

Order: SCHEDULING ORDER

Petitioner's Supplemental Mandatory Notice: Related Matters Section

Notice: Notice filing date accorded

Notice : Mandatory Notice

Notice : Power of Attorney

U.S. Patent No. 9,486,407 to Perrett et al.

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

EP2482822B1 that was revoked by the European Patent Office

The Opposition Division of the European Patent Office decision revoking EP2

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

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

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

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

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

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

The United States Pharmacopeia, USP 32, 2009 at pages 262-263 “<701>

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

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.

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

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

Teitlebaum et al., Eosinophilic esophagitis in children:

Noel et al., Clinical and immunopathologic effects

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

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

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

Wen, “Adsorption at solid surfaces: pharmaceutical applications,”

Physical Pharmacy: Physical Chemical Principles in the Pharmaceutical

Notice : Power of Attorney

Petition : as filed

Conway, “Solid dosage forms,” Chapter 4.1 in Pharmaceutical Manufacturing Handbook: Production and Processes