Dr. Falk Pharma GmbH vs Ellodi Pharmaceuticals LP

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EP2482822B1 that was revoked by the European Patent Office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DRAFT Guidance for Industry: Orally Disintegrating Tablets, FDA (CDER) 2007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