Dr. Falk Pharma GmbH vs Ellodi Pharmaceuticals LP - IPR2025-00052

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

Patent Owner's Response

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 eosinophilic 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)

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 tech-nique. 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

U.S. Patent 9,867,780

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

Jorveza® label

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 Supplemental Mandatory Notice (U.S. Patent No. 10,632,069)

Notice: Notice filing date accorded

Notice : Mandatory Notice

Notice : Power of Attorney

U.S. Patent No. 10,632,069 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 EPO decision revoking EP2484822B1

“Guidance for Industry: Orally Disintegrating Tablets,” FDA (CDER), 2008

Publication Notice, FDA Guidance, Industry re Orally Disintegrating Tablets

DRAFT Guidance for Industry: Orally Disintegrating Tablets, FDA (CDER) 2007

International Publication No. WO2000044351 to Grother et al.

Oral formulations of budesonide: a novel treatment for bowel disease (2008)

Eosinophilic gastroenteritis treated w/non-enteric-coated budesonide tablet

Evaluation of oral budesonide treatment of active distal ulcerative colitis

Eosinophilic gastroenteritis w/severe enteropathy-Successful treatment

Budesonide for the treatment of obstructive eosinophilic jejunitis, (2007)

Topical viscous budesonide suspension-treatment of eosinophilic esophagitis

Oral Viscous Budesonide, Potential new therapy for eosinophilic esophagitis

The United States Pharmacopeia, USP 32, 2009, “<701> Disintegration”

“Intraoral Drug Delivery: A Comparative Review,” (2003)

Orally fast disintegrating tablets: developments, technologies etc. (2004)

“Mouth Dissolving Tablets I: An overview of formulation technology,” (2009)

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

The Pharmacological Basis of Therapeutics, 11th edition (2005)

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 US Application No. 12/896,005 ('729 Pat.)

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

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

Prosecution history Excerpts from US Application No. 17/236,295 ('598 Pat.)

The U.S. Pharmacopeia Convention, Rev. Bulletin, “<701> Disintegration”

“Solid dosage forms,” Ch. 4.1, Pharmaceutical Manufacturing Handbook (2008)

“Magnesium Stearate,” Handbook of Pharmaceutical Excipients, 5th ed, (2006)

“Mannitol,” Handbook of Pharmaceutical Excipients, 5th edition, (2006)

“Povidone,” Handbook of Pharmaceutical Excipients, 5th edition, (2006)

“Sucralose,” Handbook of Pharmaceutical Excipients, 5th edition, (2006)

Evaluation of disintegration testing of different fast dissolving tablets

Prosecution History Excerpts from US Application No. 15/816,154 ('069 Pat.)

Prosecution History Excerpts from US Application No. 16/821,464 ('828 Pat.)

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

Notice : Power of Attorney

Petition : as filed