Amneal Pharmceuticals LLC et al. vs Almirall, LLC

Petitioner's Notice of Appeal

Termination Decision Document

Hearing Transcript

Conduct of the Proceeding

Almirall Letter to FDA

Patent Owner's Demonstratives

Petitioners' Demonstratives

Objection to Demonstratives

Updated Mandatory Notices

Patent Owner's Reply in Support of Its Motion to Exclude Evidence Under 37 C.F.R. Section 42.64

Petitioners' Updated Exhibit List

IPR2019-00207 - Institution Decision

Petitioners' Reply ISO Motion to Exclude Evidence

Order - Granting Requests for Oral Argument - 37 CFR 42.70

Petitioners' Opposition to Motion to Exclude

Opposition to Petitioners' Motion to Exclude Evidence

Motion to Exclude Evidence

Request for Oral Hearing

Patent Owner's Motion to Exclude Evidence

Patent Owner's Request for Oral Argument

Patent Owner's Sur-Reply

US Patent 9,517,219

Patent Owner's Objections to Reply Evidence

MODIFYING SCHEDULING ORDER 37 C.F.R. § 42.5

Reply to Patent Owner's Response

Petitioners' Exhibit List

Second Declaration of Elaine Gilmore

Tanghetti 2012

Fleischer, Jr. 2010

PDR - Tri-Luma

PDR - Ziana

PDR - Veltin

Dollars for Docs 2011

Harper Deposition Transcript

Second Declaration of Bozena Michniak-Kohn

Sullivan 2014

PDR - Solage

Dollars for Docs 2012

2013 CMS Data

2014 CMS Data

2015 CMS Data

2016 CMS Data

2017 CMS Data

Aczone - Dollars for Docs

List of Dr. Klibanov's clerical errors

FDA Inactive Ingredient Database Field Descriptions

FDA Inactive Ingredient Database FAQs

2010 Inactive Ingredient Database

Andersson 2007

FDA Drug Master File Database

Klibanov Deposition Transcript

Klibanov Depo Notice

Notice of Deposition of Julie Harper, M.D.

Notice of Stipulation to Extend Due Dates 2&3

Decision - Granting Patent Owner's Motion for Pro Hac Vice Admission of Ms. Elizabeth B. Hagan - 37 CFR 42.10

Petitioners' Objections to Evidence

Curriculum Vitae for Professor Alexander M. Klibanov

International Patent Application Publication No. WO 2011/014627 (¿¿¿Ahluwalia¿¿¿)

International Patent Application Publication No. WO 2009/108147 (¿¿¿Garrett I¿¿¿)

International Patent Application Publication No. WO 2010/105052 (¿¿¿Hani¿¿¿)

U.S. Patent No. 4,912,112 (¿¿¿Seydel II¿¿¿)

MaryAnn Steiner, ¿¿¿Dapsone Topical Gel for Acne,¿¿¿ J. Pharm. Soc. Wisc. 12(6): 67¿¿¿71 (2009) (¿¿¿Steiner¿¿¿)

rwrwer

Declaration of Professsor Alexander M. Klibanov

U.S. Patent No. 4,829,058 (¿¿¿Seydel I¿¿¿)

Wayback Machine Results for David Pascoe, Aczone Fails to Impress for Rosacea, Rosacea Support Group (July 23, 2012), available at https://rosacea-support.org/aczone-fails-toimpress-for-rosacea.html

S. Puavilai et al., ¿¿¿Incidence of anemia in leprosy patients treated with dapsone,¿¿¿ J. Med. Assoc. Thailand 67(7): 404¿¿¿407 (1984) (¿¿¿Puavilai¿¿¿)

World Health Organization Alert No. 117, Antimalarial chlorproguanil-dapsone (LapDap¿¿¿) withdrawn following demonstration of post-treatment haemolytic anaemia in G6PD deficient patients in a Phase III trial of chlorproguanildapsone-artesunate (Dacart¿¿¿)

Robert Lott et al., ¿¿¿Medication adherence among acne patients: A review.¿¿¿ J. Cosmetic Dermatology 9: 160¿¿¿166 (2010) (¿¿¿Lott¿¿¿)

Barry Coutinho, ¿¿¿Dapsone (Aczone) 5% Gel for the Treatment of Acne,¿¿¿ American Family Physician (Dec. 2010) (¿¿¿Coutinho¿¿¿)

Food and Drug Administration Inactive Ingredient Database (September, 2012)

European Commission¿¿¿s Scientific Committee on Consumer Safety, Opinion on Diethylene Glycol Monoethyl Ether (DEGEE) (2010) (Part 2 of 2)

Food and Drug Administration Inactive Ingredient Database (December, 2012)

Declaration of Julie Harper, M.D.

Yuko Takenaka et al., Glycolic acid chemical peeling improves inflammatory acne eruptions through its inhibitory and bactericidal effects on Propionibacterium acnes, 39 J. Dermatology 350¿¿¿354 (2012)

ACZONE Gel, 5% Prescribing Information (2008) (¿¿¿2008 Aczone 5% PI¿¿¿)

Kirk A. James et al., ¿¿¿Emerging drugs for acne,¿¿¿ Expert Opin. Emerging Drugs 14(4): 649¿¿¿659 (2009) (¿¿¿James I¿¿¿)

H.C. Korting & C. Sch¿¿llmann, ¿¿¿Current topical and systemic approaches to treatment of rosacea,¿¿¿ JEADV 23: 876¿¿¿882 (2009) (¿¿¿Korting¿¿¿)

European Commission¿¿¿s Scientific Committee on Consumer Safety, Opinion on Diethylene Glycol Monoethyl Ether (DEGEE) (2010) (Part 1 of 2)

Curriculum Vitae of Julie Harper, M.D.

John Kraft & Anatoli Freiman, Management of acne, 183 Canadian Med. Assoc. J. E430¿¿¿E435 (2011) (¿¿¿Kraft¿¿¿)

Meghan I. Dubina & Alan B. Fleisher Jr., Interaction of Topical Sulfacetamide and Topical Dapsone with Benzoyl Peroxide, 145 JAMA Dermatology 1027¿¿¿1029 (2009) (¿¿¿Dubina¿¿¿)

P. Marazzi et al., Clinical evaluation of Double Strength IsotrexinTM versus Benzamycin¿¿ in the topical treatment of mild to moderate acne vulgaris, 13 Journal of Dermatological Treatment 111¿¿¿117 (2002)

N. Kellett et al., Conjoint analysis: a novel, rigorous tool for determining patient preferences for topical antibiotic treatment for acne. A randomized controlled trial, 154 British Journal of Dermatology 524¿¿¿532 (2006)

Frank C. Powell, Rosacea, 352 New Eng. J. Med. 793¿¿¿803 (2005)

Aczone 7.5% PI

Dina Anderson, Finding a Place for Topical Anti-inflammatory Acne Therapy, Practical Dermatology 17¿¿¿18 (July 2009)

Stephen Titus & Joshua Hodge, Diagnosis and Treatment of Acne, 86 Am. Family Physician 734¿¿¿740 (2012) (¿¿¿Titus¿¿¿)

John S. Strauss, Biology of the Sebaceous Gland and the Pathophysiology of Acne Vulgaris, in Pathophysiology of Dermatologic Diseases, Second Edition, N. A. Soter and H. Baden eds., McGraw-Hill, New York 195¿¿¿210 (1991) (Strauss)

Ayumi Naito et al., Topical retinoids for acne vulgaris (Protocol), 3 The Cochrane Library (John Wiley & Sons 2008) (¿¿¿Naito¿¿¿)

Physicians¿¿¿ Desk Reference 2967¿¿¿2969 (2011) (excerpt)

Physicians¿¿¿ Desk Reference 2765¿¿¿2767 (2012) (excerpt)

Gabriella Fabbrocini et al., Resveratrol-Containing Gel for the Treatment of Acne Vulgaris, 12 Am. J. of Clinical Dermatology 131¿¿¿141 (2011) (¿¿¿Fabbrocini¿¿¿)

William D. James, Acne, 352 New Eng. J. Medicine 1463¿¿¿1472 (2005) (¿¿¿James II¿¿¿)

Janusz Marcinkiewicz et al., Topical taurine bromamine, a new candidate in the treatment of moderate inflammatory acne vulgaris¿¿¿A pilot study, 18 Eur J. Dermatology 433¿¿¿439 (2008) (¿¿¿Marcinkiewicz¿¿¿)

Clinical Study Report¿¿¿ACZ ROS 01, A phase II, randomized, partial-blind, parallel-group, active- and vehiclecontrolled, multicenter study of the safety and efficacy of Aczone (dapsone) Gel, 5% (Part 1 of 2)

Clinical Study Report¿¿¿ACZ ROS 01, A phase II, randomized, partial-blind, parallel-group, active- and vehiclecontrolled, multicenter study of the safety and efficacy of Aczone (dapsone) Gel, 5% (Part 2 of 2)

Otto H. Mills et al., Comparing 2.5%, 5%, and 10% Benzoyl Peroxide on Inflammatory Acne Vulgaris, 25 Int¿¿¿l J. Dermatology 664¿¿¿667 (1986) (¿¿¿Mills¿¿¿)

U.S. Patent Publication No. 2011/0003894 (¿¿¿Louis¿¿¿)

James Q. Del Rosso, The Use of Sodium Sulfacetamide 10%-Sulfur 5% Emollient Foam in the Treatment of Acne Vulgaris, 2 J. Clinical and Aesthetic Dermatology 26¿¿¿29 (2009) (¿¿¿Del Rosso¿¿¿)

Michael Ghods et al., The Role of Dapsone Gel in the Acne Armamentarium, The Dermatologist (June 10, 2010), available at https://www.the-dermatologist.com/content/role-dapsonegel-acne-armamentarium (¿¿¿Ghods¿¿¿)

David Pascoe, Aczone Fails to Impress for Rosacea, Rosacea Support Group (July 23, 2012), available at https://rosaceasupport.org/aczone-fails-to-impress-for-rosacea.html (¿¿¿Pascoe¿¿¿)

AZC ROS 01 Web Results Summary, A phase II, randomized, partial-blind, parallel-group, active- and vehicle-controlled, multicenter study of the safety and efficacy of Aczone (dapsone) Gel, 5% in subjects with papulopustular rosacea

John V. Ashurst et al., Pathophysiological Mechanisms, Diagnosis, and Management of Dapsone-Induced Methemoglobinemia, 110 J. Am. Osteopathic Assoc. 16¿¿¿20 (2010) (¿¿¿Ashurst¿¿¿)

J.S. Chun et al., Dapsone hypersensitivity syndrome with circulating 190-kDA and 230-kDA autoantibodies, 34 Clinical and Experimental Dermatology e798¿¿¿e801 (2009) (¿¿¿Chun¿¿¿)

U.S. Patent Publication No. 2011/0135584 (¿¿¿Mallard¿¿¿)

Deposition of Bozena B. Michniak-Kohn, Ph.D., taken November 20, 2018

NDA 21-794 FDA approval letter (July 7, 2005)

NDA 21-794 FDA approval letter (March 14, 2008)

Deposition of Elaine S. Gilmore, M.D., Ph.D., taken November 16, 2018

Patent Owner's Response

Panel Change Order

Patent Owner Almirall, LLC's Notice of Deposition of Dr. Bozena B. Michniak-Kohn Under 37 C.F.R. 42.53

Order Motion to Withdraw and Substitute Counsel

Patent Owner Almirall, LLC's Notice of Deposition of Dr. Elaine S. Gilmore Under 37 C.F.R 42.53

Declaration of Elizabeth B. Hagan in Support of Patent Owner Almirall, LLC's Motion for Admission Pro Hac Vice

Patent Owner Almirall, LLC's Motion for Pro Hac Vice Admission of Elizabeth B. Hagan Pursuant to 37 C.F.R. 42.10(c)

Patent Owner Motion for Withdrawal of Counsel

Patent Owner Almirall, LLC's Mandatory Notices Under 37 C.F.R. 42.8

Patent Owner's Revocation of Power of Attorney and New Power of Attorney Pursuant to 37 C.F.R. 42.10(b)

Patent Owner Updated Mandatory Notice

Patent Owner's Exhibit List

Ex 2001 - Confirmatory Assignment

Patent Owner's Objections to Evidence

Trial Instituted Document

Scheduling Order

Patent Owner Preliminary Response

Notice of Accepting Corrected Petition

Transmittal Letter Accompanying Exhibit 1007

Exhibit 1007 - US Pat. Appl. No. Publ. No. 20060204526

Notice of Accord Filing Date

Patent Owner's Mandatory Notices

Patent Owner's Power of Attorney and 3.73 Statement

WO 2010/072958

U.S. Patent No. 9,161,926

Michniak-Kohn CV

WO 2009/061298

Certification for Translation WO 2010/072958

U.S. Pat. Appl. Publ. No. 2010/0029781

US Pat. Appl. Publ. No. 2006/0204526

Bonacucina 2009

Gilmore CV

Aczone Product Label

U.S. Patent No. 7,820,186

Epiduo Package Insert

U.S. Pat. Appl. Publ. No. 2007/0190019

Handbook of Pharmaceutical Excipients

Osborne II

'926 File History

Lubrizol Technical Data Sheet

Lubrizol Pharmaceutical Bulletin

Wozel 2010

Thiboutot 2007

Sepineo P 600

Barclay 2009

Kim 2003

Noveon Technical Data Sheet

Remington

File History Excerpts for U.S. Patent No. 9,517,219

Piskin 2007

Williams 2012

Osborne I

Nguyen 2010

Orange Book: N207154

Michniak-Kohn Declaration

Petition

Gilmore Declaration

Power of Attorney

Exhibit List