Paper 3
`Date: May 21, 2015
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`COALITION FOR AFFORDABLE DRUGS VII LLC,
`Petitioner,
`
`v.
`
`POZEN INC.,
`Patent Owner.
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`IPR2015-01241
`Patent 6,926,907
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`PETITIONER’S EXHIBIT LIST
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`1
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`
`Date: May 21, 2015
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`COALITION FOR AFFORDABLE DRUGS VII LLC,
`Petitioner,
`
`v.
`
`POZEN INC.,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2015-01241
`Patent 6,926,907
`
`
`
`
`
`
`
`
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`
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`PETITIONER’S EXHIBIT LIST
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`1
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`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits this current list of
`
`IPR2015-01241
`Patent 6,926,907
`
`
`
`exhibits.
`
`Exhibit No. Description
`
`1001
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`1002
`
`1003
`
`1004
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`1005
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`1006
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`1007
`
`1008
`
`1009
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`1010
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`1011
`
`1012
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`1013
`
`1014
`
`U.S. Patent No. 6,926,907 (“the ’907 Patent”)
`
`File History of the ’907 Patent
`
`Declaration of Leon Shargel, Ph.D., R.Ph.
`
`U.S. Patent No. 5,698,225 (“Gimet”)
`
`U.S. Patent No. 5,204,118 (“Goldman”)
`
`“Remington’s Pharmaceutical Sciences,” Alfonso R. Gennaro, et
`al., Mack Publ’g Co., Seventeenth Edition, 1985 (“Remington”)
`
`“Does Misoprostol Given as a Single Large Dose Improve its
`Antisecretory Effect?” S.G. Chiverton, et al., Aliment. Pharmacol.
`Therap., Vol. 3 (1989) (“Chiverton”)
`
`U.S. Patent No. 4,757,060 (“Lukacsko”)
`
`“The Mechanism of Action of Aspirin,” J.R. Vane, et al., Pergamon
`(2003)
`
`G.B. Patent No. 1211134
`
`“Drug-Induced Peptic Ulcer Disease,” Valerie Vella, Journal of the
`Malta College of Pharmacy Practice (2005)
`
`“Goodman & Gilman’s The Pharmacological Basis of
`Therapeutics,” Joel G. Hardman, et al., McGraw-Hill Publ’g Co.,
`Ninth Edition (1996)
`
`U.S. Patent No. 6,365,184 (“Depui”)
`
`“Tagamet: The Discovery of Histamine H2-Receptor Antagonists,”
`SmithKlein Beecham Pharmas., Am. Chem. Soc. (Nov. 24, 1997)
`
`1
`
`
`
`
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`IPR2015-01241
`Patent 6,926,907
`
`Exhibit No. Description
`“Inhibition of Gastric (H+ + K+)-ATPase by the Substituted
`Benzimidazole Picoprazole,” B. Wallmark, et al., Biochimica et
`Biophysica Acta, Vol. 728, at 31-38 (1983)
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`U.S. Patent No. 4,255,431
`
`“Drug Discovery: Practices, Processes, and Perspectives,” Jie Jack
`Li, et al., John Wiley & Sons (Apr. 3, 2013)
`
`U.S. Patent App. Pub. 2002/0045184 (“Chen”)
`
`“Management of NSAID-Related Gastrointestinal Mucosal Injury,”
`A.F. Barrison, et al., Inflammopharmacology 7(3), at 277-86 (1999)
`
`“Prevention of NSAID-Induced Gastroduodenal Ulcers,” A.
`Rostom, et al., Cochrane Database of Systematic Reviews (2000)
`
`VIMOVO® (Naproxen and Esomeprazole Magnesium) Tablets |
`Horizon Pharma, http://www.horizonpharma.com/vimovo/ (last
`visited May 9, 2015)
`
`Horizon Pharma plc 2014 Irish Statutory Accounts,” Horizon
`Pharma Public Limited Company (Apr. 9, 2015)
`
`Nov. 19, 2004 Amendment and Response Under 37 C.F.R. § 1.116,
`File History of the ’907 Patent
`
`“Pharmaceutical Companies Buy Rivals’ Drugs, Then Jack Up the
`Prices,” The Wall Street Journal (Apr. 26, 2015)
`
`Oct. 20, 2004 Final Office Action, File History of the ’907 Patent
`
`Nov. 19, 2004 Request for Continued Examination, File History of
`the ’907 Patent
`
`Mar. 29, 2005 Notice of Allowance and Fee(s) Due, File History of
`the ’907 Patent
`
`2
`
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`
`
`Exhibit No. Description
`
`IPR2015-01241
`Patent 6,926,907
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`Dec. 25, 2007 Certificate of Correction, File History of the ’907
`Patent
`
`“Clinical Trial: Evaluation of Gastric Acid Suppression with Three
`Doses of Immediate-Release Esomeprazole in the Fixed-Dose
`Combination of PN 400 (Naproxen/Esomeprazole Magnesium)
`Compared with
`Naproxen 500 mg and Enteric-Coated Esomeprazole 20 mg: A
`Randomized, Open-Label, Phase I Study in Healthy Volunteers,”
`Miner et al., Alim. Pharmacol. Ther., 32:414-424 (2010)
`(“Miner”)
`
`Nexium 24HR Acid Reducer, 42 Capsules – Walmart.com,
`http://www.walmart.com/ip/Nexium-24HR-Acid-Reducer-42-
`Capsules/35284453 (last visited May 9, 2015)
`
`“Effects of Misoprostol on Gastric Acid and Mucus Secretion in
`Man,” Donald E. Wilson, et al., Digestive Diseases and Sciences,
`Vol. 31, No. 2 (Feb. 1986)
`
`“Misoprostol Versus Antacid Titration for Preventing Stress Ulcers
`in Postoperative Surgical ICU Patients,” Michael J. Zinner, MD, et
`al., Ann. Surg., Vol. 210, No. 5 (Nov. 1989)
`
`“COX-2 Inhibitors,” Peter M. Brooks, et al., Australian Prescriber
`(Feb. 1, 2000)
`
`“Effect of Orally Administered Prostaglandin E2 and its 15-Methyl
`Analogues on Gastric Secretion,” Karim, et al., British Med.
`Journal (Jan. 20, 1973)
`
`“Effect of Increasing Gastric pH with Famotidine on the
`Absorption and Oral Pharmacokinetics of the Inotropic Agent
`Vesnarinone,” B. Koneru, et al., J. Clin. Pharmacol. (1998)
`
`3
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`Exhibit No. Description
`
`IPR2015-01241
`Patent 6,926,907
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`“Twenty-Four-Hour Intragastric pH Profiles and Pharmacokinetics
`Following Single and Repeated Oral Administration of the Proton
`Pump Inhibitor Pantoprazole in Comparison to Omeprazole,” M.
`Hartmann, et al., Aliment Pharmacol. Ther. (Jan. 3, 1996)
`
`“Effects of Famotidine on Gastric pH and Residual Volume in
`Pediatric Surgery.” J.S. Jahr, et al., Acta Aneasthesiol Scand.
`(1991)
`
`“Effect of Preanesthetic Famotidine on Gastric Volume and pH,”
`Takahiko Okuda, et al., Journal of Anesthesia, Vol. 2, Issue 1 (Mar.
`1988)
`
`“Effect of Oral and Intramuscular Famotidine on pH and Volume
`of Gastric Contents,” Kazuo Abe, M.D., et al., Anesth. Analg.
`(1989) (“Abe”)
`
`“High-Viscosity HPMC as a Film-Coating Agent,” G. Maffione, et
`al., Drug Dev. & Indus. Pharmacy (1993)
`
`“Upper Gastrointestinal (GI) pH in Young, Healthy Men and
`Women,” Jennifer B. Dressman, et al., Pharmaceutical Research,
`Vol. 7, No. 7, 756-761 (1990)
`
`FDA Response to Horizon’s Citizen Petition
`
`Notice of Final Determination, In re: Patent Term Extension for
`U.S. Patent No. 6,143,771
`
`“Prevention of the Gastrointestinal Adverse Effects of Nonsteroidal
`Anti-Inflammatory Drugs, Gregor J.E. Brown, et al., Drug Safety
`(6): 503-512 (December 21, 1999)
`
`“Abolition by Omeprazole of Aspirin Induced Gastric Mucosal
`Injury in Man,” T K Daneshmend et al., Gut, Vol. 31, 514-517
`(1990) (“Daneshmend”)
`
`1046
`
`U.S. Patent No. 6,319,519
`
`4
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`Exhibit No. Description
`
`IPR2015-01241
`Patent 6,926,907
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`1055
`
`Shargel Walmart Receipts
`
`“Pantoprazole A Review of its Pharmacological Properties and
`Therapeutic Use in Acid-Related Disorders,” A. Fitton, et al.,
`Drugs, Vol. 51, Issue 3 (Mar. 1996) (“Fitton”)
`
`“The Pathophysiological and Pharmacological Basis of Peptic
`Ulcer Therapy,” J. Freston, Toxicologic Pathology, Vol, 16, No. 2
`(1988)
`
`“Measurement of Gastrointestinal pH Profiles in Normal Ambulant
`Human Subjects,” D. F. Evans, et al., Gut, Vol. 29, 1035-1041
`(1988) (“Evans”)
`
`“Intragastric pH and Serum Gastrin During Administration of
`Different Doses of Pantoprazole in Healthy Subjects,” H. Koop, et
`al., European Journal of Gastroenterology & Hepatology (Sept.
`1996)
`
`“Omeprazole: A Preliminary Review of Its Pharmacodynamic and
`Pharmacokinetic Properties, and Therapeutic Potential in Peptic
`Ulcer Disease and Zollinger- Ellison Syndrome,” Clissold et al.,
`Drugs, 32, 15-47 (1986) (“Clissold”)
`
`“Development of an Oral Formulation of Omeprazole,” Pilbrant
`and Cederberg, Scand. J. Gastroenterol., 20(Suppl. 108):113-120
`(1985) (“Pilbrant”)
`
`“Effects of Single and Repeated Doses of Omeprazole in Gastric
`Acid and Pepsin Secretion in Man,” Howden et al., Gut, Vol. 25,
`707-710 (1984) (“Howden”)
`
`“Omeprazole: A Study of Its Inhibition of Gastric pH and Oral
`Pharmacokinetics After Morning or Evening Dosage,” Prichard et
`al., Gastroenterol., 88:64-69 (1985) (“Prichard”)
`
`5
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`Exhibit No. Description
`
`IPR2015-01241
`Patent 6,926,907
`
`1056
`
`“The Effects of Oral Doses of Lansoprazole and Omeprazole on
`Gastric pH,” Tolman et al., J. Clin. Gastroenterol, 24(2):65-70
`(1997) (“Tolman”)
`
`1057
`
`Horizon’s Citizen Petition (February 4, 2014)
`
`
`
`
`Date: May 21, 2015
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`Respectfully submitted,
`
`
`
`
`/Amy E. LaValle/
`Amy E. LaValle (Reg. No. 51,092)
`Jerry C. Harris, Jr. (Reg. No. 66,822)
`Rodney B. Carroll (Reg. No. 39,624)
`Conley Rose, P.C.
`5601 Granite Parkway, Suite 500
`Plano, Texas 75024
`(972) 731-2288 (phone)
`(972) 731-2289 (fax)
`alavalle@conleyrose.com
`jcharris@conleyrose.com
`rcarroll@conleyrose.com
`
`Counsel for Petitioner
`Coalition for Affordable Drugs VII LLC
`
`6
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`CERTIFICATE OF SERVICE
`
`IPR2015-01241
`Patent 6,926,907
`
`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on May 21, 2015 a
`
`copy of the foregoing PETITIONER’S EXHIBIT LIST and copies of the listed
`
`Exhibits were provided via FedEx, overnight delivery, to the Patent Owner by
`
`serving the correspondence address of record for the ’907 Patent:
`
`Steven L. Highlander
`Parker Highlander PLLC
`1120 South Capital of Texas Highway
`Bldg. 1, Suite 200
`Austin, Texas 78746
`
`
`Date: May 21, 2015
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`
`
`/Amy E. LaValle/
`Lead Counsel for Petitioner
`Coalition for Affordable Drugs VII LLC
`
`
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`7
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