`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`Filed: May 8, 2019
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC. and
`DR. REDDY’S LABORATORIES, INC.,
`Petitioners
`
`v.
`
`HORIZON PHARMA USA, INC. and NUVO PHARMACEUTICALS
`(IRELAND) DESIGNATED ACTIVITY COMPANY,
`
`Patent Owners
`
`Case No. IPR2018-002721
`U.S. Patent No. 9,393,208 B2
`
`
`
`
`
`UPDATED LIST OF PETITIONERS’ EXHIBITS
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioners submit the following current
`
`exhibit list.
`
`
`1 Petitioner Dr. Reddy’s Laboratories, Inc. from IPR2018-01341, has been joined
`
`as a Petitioner to this proceeding.
`
`1
`
`
`
`Exhibit
`1001
`
`1002
`1003
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`1010
`1011
`
`Description
`U.S. Patent No. 9,393,208, Method for Delivering a
`Pharmaceutical Composition to Patient in need thereof (filed
`Dec. 28, 2015) (issued Jul. 19, 2016) (“the ’208 patent”)
`Declaration of David C. Metz, M.D. (“Metz Decl.”)
`Declaration of Michael Mayersohn, Ph.D. (“Mayersohn Decl.”)
`U.S. Patent No. 6,926,907, Pharmaceutical Compositions for the
`Coordinated Delivery of NSAIDS (filed May 31, 2002) (issued
`Aug. 9, 2005)
`U.S. Patent No. 8,557,285, Pharmaceutical Compositions for the
`Coordinated Delivery of NSAIDS (filed Aug. 23, 2011) (issued
`Oct. 15, 2013)
`Howden, Review Article: Immediate-Release Proton-Pump
`Inhibitor Therapy – Potential Advantages, 22 (Suppl. 3)
`ALIMENT. PHARMACOL. THER. 25 (2005)
`U.S. Patent No. 5,877,192, Method for the Treatment of Gastric
`Acid-Related Diseases and Production of Medication using (-)
`Enantiomer of Omeprazole (filed Apr. 11, 1997) (issued Mar. 2,
`1999)
`Products on NDA 020067 (EC-Naprosyn), FDA.GOV,
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=
`overview.process&ApplNo=020067 (last visited Aug. 23, 2017)
`EC-Naprosyn prescribing information (2007)
`Zegerid approval letter and prescribing information (2004)
`Goldstein et al., 116 A Single Tablet Multilayer Formulation of
`Enteric-Coated Naproxen Coupled with Non-Enteric Coated
`OMEPRAZOLE is Associated with a Significantly Reduced
`Incidence of Gastric Ulcers vs. Enteric-Coated Naproxen: A
`Prospective, Randomized, Double-Blind Study, 134(4)
`GASTROENTEROLOGY A19 (2008)
`
`2
`
`
`
`Exhibit
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`Description
`Hochberg et al., A Novel, Single-Tablet Formulation that Delivers
`Immediate-Release Omeprazole Followed by Enteric-Coated
`(EC) Naproxen Significantly Reduces the Incidence of Gastric
`Ulcers Compared with EC Naproxen Alone: Results of a
`Prospective, Randomised, Double-Blind, 6-Month Study including
`Patients with OA and RA, EULAR (2008)
`U.S. Patent No. 9,220,698 Prosecution History Excerpt:
`Amendment C and Response to Final Office Action (Jan. 30,
`2013)
`Wolfe et al., Acid Suppression: Optimizing Therapy for
`Gastroduodenal Ulcer Healing, Gastroesophageal Reflux
`Disease, and Stress-Related Erosive Syndrome, 118
`GASTROENTEROLOGY S9 (2000)
`Bell et al., Appropriate Acid Suppression for the Management of
`Gastro-Oesophageal Reflux Disease, 51(suppl. 1) DIGESTION 59
`(1992)
`Hassan-Alin et al., Lack of Pharmacokinetic Interaction between
`Esomeprazole and the Nonsteroidal Anti-Inflammatory Drugs
`Naproxen and Rofecoxib in Healthy Subjects, 25(11) CLIN. DRUG
`INVEST. 731 (2006)
`Khosravan et al., Pharmacokinetic Interactions of Concomitant
`Administration of Febuxostat and NSAIDs, 46 J. CLIN. PHARMA.
`855 (2006)
`Jung et al., Steady-State Pharmacokinetics of Enteric-Coated
`Naproxen Tablets Compared with Standard Naproxen Tablets,
`16(6) CLIN. THER. 923 (1994)
`Davies et al., Clinical Pharmacokinetics of Naproxen, 32(4) CLIN.
`PHARMACOKINET. 268 (1997)
`Naprosyn/EC-Naprosyn/Anaprox DS Prescribing Information
`(2017)
`Dan M. Roden, Principles of Clinical Pharmacology, in
`HARRISON’S PRINCIPLES OF INTERNAL MEDICINE 13 (Dennis L.
`Kasper et al. eds., 16th ed. 2005)
`
`3
`
`
`
`Exhibit
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`1031
`
`1032
`
`1033
`
`1034
`1035
`1036
`
`Description
`Malcolm Rowland & Thomas N. Tozer, CLINICAL
`PHARMACOKINETICS (3d ed. 1995)
`Clissold et al., Omeprazole A Preliminary Review of its
`Pharmacodynamic and Pharmacokinetic Properties, and
`Therapeutic Potential in Peptic Ulcer Disease and Zollinger-
`Ellison Syndrome, 32 DRUGS 15 (1986)
`U.S. Patent No. 7,411,070, Form of S-Omeprazole (filed Sept. 25,
`2003) (issued Aug. 12, 2008)
`U.S. Patent No. 5,714,504, Compositions (filed Jan. 23, 1995)
`(issued Feb. 3, 1998)
`Michael Mayersohn, Principles of Drug Absorption, in MODERN
`PHARMACEUTICS 21 (3d ed. 1996)
`Howden, Clinical Pharmacology of Omeprazole, 20(1) CLIN.
`PHARMACOKINET. 38 (1991)
`Lind et al., Esomeprazole Provides Improved Acid Control vs.
`Omeprazole in Patients with Symptoms of Gastro-Oesophageal
`Reflux Disease, 14 ALIMENT. PHARMACOL. THER. 861 (2000)
`Regårdh et al., Pharmacokinetics and Metabolism of Omeprazole
`in Animals and Man – An Overview, 20(suppl. 108) SCAND. J.
`GASTROENTEROL 79 (1985)
`Vimovo prescribing information (2014)
`Target, WEBSTER’S NEW WORLD COLLEGE DICTIONARY (4th ed.
`2005)
`Target, THE AMERICAN HERITAGE DICTIONARY OF THE ENGLISH
`LANGUAGE (4th ed. 2006)
`Target, MERRIAM-WEBSTER’S CONCISE DICTIONARY (Large print
`ed. 2006)
`Intentionally Left Blank
`Intentionally Left Blank
`Intentionally Left Blank
`
`4
`
`
`
`Exhibit
`1037
`1038
`1039
`1040
`1041
`1042
`
`1043
`
`1044
`
`1045
`
`1046
`1047
`1048
`1049
`1050
`1051
`
`Description
`
`Intentionally Left Blank
`Intentionally Left Blank
`Intentionally Left Blank
`Intentionally Left Blank
`Intentionally Left Blank
`Goldlust et al., Nighttime Dosing of Omeprazole Immediate-
`Release Oral Suspension Rapidly Decreases Nocturnal Gastric
`Acidity, 99(10) AM. J. GASTROENTEROLOGY S39 (2004)
`Nexium Prescribing Information (2001), available at
`https://www.accessdata.fda.gov/
`drugsatfda_docs/label/2001/21153lbl.pdf (last visited Nov. 22,
`2017)
`Prilosec Prescribing Information (2002), available at
`https://www.accessdata.fda.gov/
`drugsatfda_docs/label/2002/19810s074lbl.pdf (last visited Nov.
`22, 2017)
`Opinion & Order, Horizon Pharma, Inc. v. Dr. Reddy’s Labs.,
`Inc., No. 15-cv-3324-SRC-CLW (consolidated) (D.N.J. Nov. 14,
`2017), ECF No. 82
`U.S. Patent No. 9,393,208 Prosecution History Excerpts
`Intentionally Left Blank
`Intentionally Left Blank
`Intentionally Left Blank
`Intentionally Left Blank
`Order (A) Authorizing the Sale of Certain of the Debtors’ Assets
`Pursuant to the Stalking Horse Agreement Free and Clear of
`Liens, Claims, Encumbrances, and Other Interests to the Fullest
`Extent Permitted by Law; (B) Approving the Assumption and
`Assignment of Certain Executory Contracts; and (C) Granting
`Related Relief, In re Aralez Pharmaceuticals US Inc., No. 18-
`2425-mg (Bankr. S.D.N.Y. Dec. 27, 2018), ECF No. 412
`
`5
`
`
`
`Exhibit
`1052
`
`1053
`1054
`
`1055
`
`1056
`
`1057
`
`1058
`
`1059
`1060
`
`1061
`
`1062
`
`1063
`
`1064
`
`1065
`1066
`
`Description
`Asset Purchase Agreement, In re Aralez Pharmaceuticals US Inc.,
`No. 18-2425 (Bankr. S.D.N.Y. Dec. 27, 2018), ECF No. 412-1
`Intentionally Left Blank
`Declaration of Autumn N. Nero in Support of Motion for Pro Hac
`Vice Admission of Autumn N. Nero
`Declaration of Bryan D. Beel in Support of Motion for Pro Hac
`Vice Admission of Bryan D. Beel
`Plaintiffs’ Notice of Appeal, Horizon Pharma, Inc. v. Mylan
`Pharm. Inc., No. 16-cv-4921 (D.N.J. Feb. 21, 2019), ECF No. 84
`Plaintiffs’ Notice of Appeal, Horizon Pharma, Inc. v. Dr. Reddy’s
`Labs. Inc., No. 15-cv-3324 (D.N.J. Feb. 21, 2019), ECF No. 179
`Plaintiffs’ Notice of Appeal, Horizon Pharma, Inc. v. Mylan
`Pharm. Inc., No. 15-cv-3327 (D.N.J. Feb. 21, 2019), ECF No. 69
`Reply Declaration of David C. Metz, M.D.
`Hawkey et al., Omeprazole Compared with Misoprostol for
`Ulcers Associated with Nonsteroidal Antiinflammatory Drugs,
`338(11) NEW ENG. J. MED. 727 (1998)
`Yeomans et al., A Comparison of Omeprazole with Ranitidine for
`Ulcers Associated with Nonsteroidal Anti-Inflammatory Drugs,
`338(11) NEW ENG. J. MED. 719 (1998)
`Agrawal et al., Misoprostol Compared with Sucralfate in the
`Prevention of Nonsteroidal Anti-Inflammatory Drug-Induced
`Gastric Ulcer, 115(3) ANNALS INTER. MED. 195 (1991)
`Brown et al., Prevention of the Gastrointestinal Adverse Effects of
`Nonsteroidal Anti-Inflammatory Drugs: The Role of Proton Pump
`Inhibitors, 21(6) DRUG SAFETY 503 (1999)
`EC-Naprosyn, in PHYSICIANS’ DESK REFERENCE 2631-34 (54 ed.
`2000)
`Nexium prescribing information (2007)
`EC-Naprosyn prescribing information (2004)
`
`6
`
`
`
`Exhibit
`1067
`
`1068
`
`1069
`
`1070
`
`1071
`
`1072
`
`1073
`
`1074
`1075
`
`1076
`
`1077
`
`1078
`1079
`
`Description
`Katz et al., Intragastric Acid Suppression and Pharmacokinetics
`of Twice-Daily Esomeprazole: A Randomized, Three-Way
`Crossover Study, 20 ALIMENT. PHARMACOL. THER. 399 (2004)
`Junghard et al., The Effect of the Area Under the Plasma
`Concentration vs Time Curve and the Maximum Plasma
`Concentration of Esomeprazole on Intragastric pH, 58 EUR. J.
`CLIN. PHARMACOL. 453 (2002)
`Hammer et al., Effect of Splitting the Dose of Esomeprazole on
`Gastric Acidity and Nocturnal Acid Breakthrough, 19 ALIMENT.
`PHARMACOL. THER. 1105 (2004)
`International Publication No. WO 97/25064 (published July 17,
`1997)
`U.S. Patent No. 5,601,843, Pharmaceutical Tablet Composition
`(filed July 18, 1994) (issued Feb. 11, 1997)
`U.S. Patent No. 6,544,556, Pharmaceutical Formulations
`Containing a Non-Steroidal Antiinflammatory Drug and a Proton
`Pump Inhibitor (filed Sept. 11, 2000) (issued Apr. 8, 2003)
`Ekström et al., Prevention of Peptic Ulcer and Dyspeptic
`Symptoms with Omeprazole in Patients Receiving Continuous
`Non-Steroidal Anti-Inflammatory Drug Therapy, 31 SCAND. J.
`GASTROENTEROL. 753 (1996)
`Reply Declaration of Michael Mayersohn, Ph.D.
`Trial Transcript vol. 6, Horizon Pharma, Inc. v. Dr. Reddy’s
`Labs., Inc., Case No. 3:11-cv-02317 (D.N.J. Jan. 20, 2017)
`EC-Naprosyn, in PHYSICIANS’ DESK REFERENCE 2967-70 (56 ed.
`2002)
`Miner et al., Gastric Acid Control with Esomeprazole,
`Lansoprazole, Omeprazole, Pantoprazole, and Rabeprazole: A
`Five-Way Crossover Study, 98(12) AM. J. GASTRO. 2616 (2003)
`Intentionally Left Blank
`Deposition of David R. Taft (Aug. 17, 2018)
`
`7
`
`
`
`Exhibit
`1080
`1081
`
`1082
`
`1083
`
`1084
`
`1085
`1086
`
`1087
`
`1088
`
`1089
`
`Description
`U.S. Patent Application No. 61/095,584 prosecution history
`Office Action Summary, U.S. Patent Application No. 12/553,107
`(June 16, 2014)
`Office Action Summary, U.S. Patent Application No. 12/553,107
`(Mar. 26, 2015)
`FDA Website, Orange Book, Vimovo, FDA.GOV,
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?P
`roduct_No=002& Appl_No=022511&Appl_type=N (last visited
`May 7, 2019)
`U.S. Patent No. 6,365,184, Oral Pharmaceutical Dosage Forms
`Comprising A Proton Pump Inhibitor and a NSAID (filed Dec. 23,
`1999) (issued Apr. 2, 2002)
`Deposition of David A. Johnson, M.D. (May 3, 2019)
`Declaration of David A. Johnson, M.D., Mylan Pharm. Inc. v.
`Pozen Inc., IPR2017-01995, Ex. 2026 (PTAB June 1, 2018)
`Decision, Mylan Pharm. Inc. v. Pozen Inc., IPR207-01995, Paper
`18 (PTAB Mar. 8, 2018)
`EC-Naprosyn, in PHYSICIANS’ DESK REFERENCE 2631-34 (54 ed.
`2000)
`U.S. Patent No. 9,220,698, Method for Delivering a
`Pharmaceutical Composition to Patient in Need Thereof (filed
`Sept. 3, 2009) (issued Dec. 29, 2015)
`
`Dated: May 8, 2019
`
`
`
`/s/ Brandon M. White
`Brandon M. White
`Reg. No. 52,354
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`E-mail: bmwhite@perkinscoie.com
`
`8
`
`
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that the foregoing Updated List of
`
`Petitioners’ Exhibits was served electronically via email as follows:
`
`Thomas A. Blinka
`Jonathan G. Graves
`Ellen Scordino
`Lauren Krickl
`Cooley LLP
`zIPR2018-00272@cooley.com
`
`Margaret J. Sampson
`Stephen M. Hash
`Jeffrey S. Gritton
`Baker Botts LLP
`nuvo-vimovoBB@bakerbotts.com
`
`Petitioner Dr. Reddy’s :
`Alan H. Pollack
`Stuart D. Sender
`Louis H. Weinstein
`Windels Marx Lane & Mittendorf, LLP
`apollack@windelsmarx.com
`ssender@windelsmarx.com
`lweinstein@windelsmarx.com
`
`Date: May 8, 2019
`
`/s/ Brandon M. White
`Brandon M. White
`Reg. No. 52,354
`
`Attorneys for Petitioner Mylan Pharmaceuticals
`Inc.
`
`
`
`
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