Dr. Falk Pharma GmbH vs Ellodi Pharmaceuticals LP

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EP2482822B1 that was revoked by the European Patent Office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DRAFT Guidance for Industry: Orally Disintegrating Tablets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