Paper 3
`Date: August 7, 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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`IPR2015-01680
`Patent 8,852,636
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`PETITIONER’S EXHIBIT LIST
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`
`
`Date: August 7, 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.
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
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`
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`IPR2015-01680
`Patent 8,852,636
`
`
`
`
`
`
`
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`PETITIONER’S EXHIBIT LIST
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`
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`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits this current list of
`
`IPR2015-01680
`Patent 8,852,636
`
`
`
`exhibits.
`
`Exhibit No. Description
`
`1001
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`1002
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`1003
`
`1004
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`1005
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`1006
`
`1007
`
`1008
`
`1009
`
`1010
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`1011
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`1012
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`1013
`
`1014
`
`1015
`
`U.S. Patent No. 8,852,636 (“the ’636 Patent”)
`
`File History of the ’636 Patent, U.S. Patent App. No. 14/045,156
`(“the ’156 Application”)
`
`Declaration of Leon Shargel, Ph.D., R.Ph.
`
`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”)
`
`U.S. Patent No. 5,698,225 (“Gimet”)
`
`U.S. Patent No. 5,714,504 (“Lindberg”)
`
`U.S. Patent No. 6,183,779 (“Ouali”)
`
`U.S. Patent No. 6,926,907 (“the ’907 Patent”)
`
`Certificate of Correction for the ’907 Patent (December 25, 2007)
`
`“Esomeprazole Provides Improved Acid Control vs. Omeprazole in
`Patients with Symptoms of Gastro-Oesophageal Reflux Disease,”
`T. Lind, et al., Alimentary Pharmacology & Therapeutics, Vol. 14,
`Issue 7 (July 2000) (“Lind”)
`
`U.S. Patent No. 4,757,060
`
`“The Mechanism of Action of Aspirin,” J.R. Vane, et al., Pergamon
`(June 15, 2003)
`
`G.B. Patent No. 1211134
`
`“Drug-Induced Peptic Ulcer Disease,” Valerie Vella, Journal of the
`Malta College of Pharmacy Practice, Issue 10 (2005)
`
`2
`
`
`
`
`
`Exhibit No. Description
`
`IPR2015-01680
`Patent 8,852,636
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`“Goodman & Gilman’s The Pharmacological Basis of
`Therapeutics,” Joel G. Hardman, et al., McGraw-Hill Publ’g Co.,
`Ninth Edition (1996)
`
`“Upper Gastrointestinal (GI) pH in Young, Healthy Men and
`Women,” Jennifer B. Dressman, et al., Pharmaceutical Research,
`Vol. 7, No. 7 (July 1990)
`
`“Effect of Orally Administered Prostaglandin E2 and its 15-Methyl
`Analogues on Gastric Secretion,” S. M. M. Karim, et al., British
`Med. Journal (Jan. 20, 1973)
`
`“Tagamet: The Discovery of Histamine H2-Receptor Antagonists,”
`SmithKlein Beecham Pharm., Am. Chem. Soc. (Nov. 24, 1997)
`“Inhibition of Gastric (H+ + K+)-ATPase by the Substituted
`Benzimidazole Picoprazole,” B. Wallmark, et al., Biochimica et
`Biophysica Acta, Vol. 728, Issue 1 (Sept. 2, 1983)
`
`U.S. Patent No. 4,255,431
`
`Notice of Final Determination, In re: Patent Term Extension for
`U.S. Patent No. 6,143,771 (July 28, 2005)
`
`“Drug Discovery: Practices, Processes, and Perspectives,” Jie Jack
`Li, et al., John Wiley & Sons (Apr. 3, 2013)
`
`“Prevention of the Gastrointestinal Adverse Effects of Nonsteroidal
`Anti-Inflammatory Drugs,” Gregor J.E. Brown, et al., Drug Safety,
`Vol. 21, Issue 6 (Dec. 21, 1999)
`
`U.S. Patent App. Pub. No. 2002/0045184 (“Chen”)
`
`“Management of NSAID-Related Gastrointestinal Mucosal Injury,”
`Adam F. Barrison, et al., Inflammopharmacology, Vol. 7, No. 3
`(Sept. 1999)
`
`3
`
`
`
`
`
`Exhibit No. Description
`
`IPR2015-01680
`Patent 8,852,636
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`“Prevention of NSAID-Induced Gastroduodenal Ulcers,” A.
`Rostom, et al., Cochrane Database of Systematic Reviews, Issue 4
`(2002)
`
`“Abolition by Omeprazole of Aspirin Induced Gastric Mucosal
`Injury in Man,” T. K. Daneshmend, et al., Gut, Vol. 31, Issue 5
`(May 1990)
`
`U.S. Patent No. 6,319,519
`
`U.S. Patent No. 6,365,184 (“Depui”)
`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)
`
`Shargel Walmart Receipts
`
`Int’l Patent Pub. No. WO 98/54171
`
`U.S. Patent No. 6,262,085
`
`U.S. Patent Pub. No. 2001/0000468
`
`U.S. Patent No. 5,051,262
`
`“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)
`
`“Measurement of Gastrointestinal pH Profiles in Normal Ambulant
`Human Subjects,” D. F. Evans, et al., Gut, Vol. 29, Issue 8 (Aug.
`1988) (“Evans”)
`
`“Omeprazole,” Stephen P. Clissold, et al., Drugs, Vol. 32, Issue 1
`(July 1986) (“Clissold”)
`
`4
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`Exhibit No. Description
`
`IPR2015-01680
`Patent 8,852,636
`
`1041
`
`1042
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`1043
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`1044
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`1045
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`1046
`
`“Development of an Oral Formulation of Omeprazole,” A. Pilbrant,
`Scandinavian Journal of Gastroenterology, Vol. 20, No. s108
`(1985) (“Pilbrant”)
`
`“Effects of Single and Repeated Doses of Omeprazole on Gastric
`Acid and Pepsin Secretion in Man,” C. W. Howden, et al., Gut,
`Vol. 25, Issue 7 (July 1984) (“Howden”)
`
`“Omeprazole: A Study of Its Inhibition of Gastric pH and Oral
`Pharmacokinetics After Morning or Evening Dosage,” Peter J.
`Prichard, et al., Gastroenterology, Vol. 88, Issue 1, Part 1 (Jan.
`1985) (“Prichard”)
`
`“The Effects of Oral Doses of Lansoprazole and Omeprazole on
`Gastric pH,” Keith G. Tolman, et al., Journal of Clinical
`Gastroenterology, Vol. 24, Issue 2 (Mar. 1997) (“Tolman”)
`
`Citizen Petition, Horizon Pharma (Feb. 3, 2014)
`
`“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,” P. Miner, Jr., et al., Alimentary
`Pharmacology & Therapeutics, Vol. 32, Issue 3 (Aug. 2010)
`(“Miner”)
`
`1047
`
`
`
`FDA Response to Horizon’s Citizen Petition (July 3, 2014)
`
`
`5
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`IPR2015-01680
`Patent 8,852,636
`
`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
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`6
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`Date: August 7, 2015
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`CERTIFICATE OF SERVICE
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`IPR2015-01680
`Patent 8,852,636
`
`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on August 7, 2015 a
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`copy of the foregoing PETITIONER’S EXHIBIT LIST and copies of the listed
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`Exhibits were provided via FedEx, overnight delivery, to the Patent Owner by
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`serving the correspondence address of record for the ’636 Patent:
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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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`Steven L. Highlander
`Parker Highlander PLLC
`1120 South Capital of Texas Highway
`Bldg. 1, Suite 200
`Austin, Texas 78746
`
`
`
`Date: August 7, 2015
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