`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`Filed: January 25, 2018
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner
`
`v.
`
`POZEN INC. and HORIZON PHARMA USA, INC.,
`
`Patent Owners
`
`Case No. IPR2017-01995
`U.S. Patent No. 9,220,698
`
`
`
`
`
`UPDATED LIST OF PETITIONER’S EXHIBITS
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits the following current
`
`exhibit list.
`
`Exhibit
`1001
`
`1002
`1003
`
`Description
`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) (“the ’698 patent”)
`Declaration of David C. Metz, M.D. (“Metz Decl.”)
`Declaration of Michael Mayersohn, Ph.D. (“Mayersohn Decl.”)
`
`1
`
`
`
`Exhibit
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`Description
`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 (Jan. 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)
`
`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)
`
`2
`
`
`
`Exhibit
`1013
`
`Description
`U.S. Patent No. 9,220,698 Prosecution History Excerpt:
`Amendment C and Response to Final Office Action (Jan. 30,
`2013)
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`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
`(Mar. 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)
`Malcolm Rowland & Thomas N. Tozer, CLINICAL
`PHARMACOKINETICS (3d ed. 1995)
`
`3
`
`
`
`Exhibit
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`Description
`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 (Dec. 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)
`U.S. Patent No. 9,220,698 Prosecution History Excerpt: Office
`Action Summary (Jan. 5, 2012)
`U.S. Patent No. 9,220,698 Prosecution History Excerpt: Office
`Action Summary (July 30, 2012)
`U.S. Patent No. 9,220,698 Prosecution History Excerpt: Office
`Action Summary (June 16, 2014)
`
`4
`
`
`
`Exhibit
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`1044
`1045
`1046
`1047
`
`Description
`U.S. Patent No. 9,220,698 Prosecution History Excerpt: Office
`Action Summary (Mar. 26, 2015)
`U.S. Patent No. 9,220,698 Prosecution History Excerpt:
`Amendment B in Response to January 5, 2012 Office Action
`(May 8, 2012)
`U.S. Patent No. 9,220,698 Prosecution History Excerpt: Response
`to Non-Final Office Action Mailed June 16, 2014 (Dec. 12, 2014)
`U.S. Patent No. 9,220,698 Prosecution History Excerpt: Response
`to Final Office Action Mailed March 26, 2015 (Sept. 25, 2015)
`U.S. Patent No. 9,220,698 Prosecution History Excerpt: Advisory
`Action (Oct. 9, 2015)
`Goldlust et al., Nighttime Dosing of Omeprazole Immediate-
`Release Oral Suspension Rapidly Decreases Nocturnal Gastric
`Acidity, 99(10) AM. J. GASTROENTEROLOGY S39 (2004)
`INTENTIONALLY LEFT BLANK
`INTENTIONALLY LEFT BLANK
`INTENTIONALLY LEFT BLANK
`INTENTIONALLY LEFT BLANK
`Stipulation and Order to Dismiss Certain Counterclaims, Horizon
`Pharma, Inc. v. Mylan Pharms. Inc., No. 15-cv-3327 (D.N.J.
`Feb. 23, 2017), ECF No. 40
`
`
`
`Dated: January 25, 2018
`
`
`
`
`
`/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
`
`5
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing Updated List of
`
`Petitioner’s Exhibits was served electronically via email as follows:
`
`Thomas A. Blinka
`Jonathan G. Graves
`Susan Krumplitsch
`Cooley LLP
`zIPR2017-01995@cooley.com
`
`Margaret J. Sampson
`Stephen M. Hash
`Jeffrey S. Gritton
`Baker Botts LLP
`vimovoBB@bakerbotts.com
`
`
`
`
`Date: January 25, 2018
`
`/s/ Brandon M. White
`Brandon M. White
`
`Attorneys for Petitioner Mylan Pharmaceuticals
`Inc.
`
`
`
`
`
`
`
`
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