UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`
`
`COALITION FOR AFFORDFABLE DRUGS VII, LLC,
`Petitioner,
`
`
`
`
`
`v.
`
`POZEN INC.,
`Patent Owner.
`
`___________
`
`
`
`Case IPR2015-01718
`Patent 8,945,621
`
`___________
`
`
`
`PATENT OWNER EXHIBIT LIST
`
`
`
`

`
`PATENT OWNER EXHIBIT LIST
`
`2002
`
`Exhibit No. Exhibit Description
`2001
`License Agreement between Patent Owner Pozen Inc. and
`exclusive licensee Horizon Pharma, Inc.
`Bhatt, D., et al., “ACCF/ACG/AHA 2008 Expert Consensus
`Document on Reducing the Gastrointestinal risks of Antiplatelet
`Therapy and NSAID Use: A Report of the American College of
`Cardiology Foundation Task Force on Clinical Expert Consensus
`Documents,” J Am Coll Cardiol, Vol. 52, No. 18, pp. 1502–1517
`(2008)
`PREVACID® (lansoprazole) Delayed-Release Capsules,
`Prescribing Information (May 1, 2001), downloaded from
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda
`/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist on
`November 17, 2015
`Laine, L., et al., “Assessment of Upper Gastrointestinal Safety of
`Etoricoxib and Diclofenac in Patients with Osteoarthritis and
`Rheumatoid Arthritis in the Multinational Etoricoxib and
`Diclofenac Arthritis Longterm (MEDAL) Programme: a
`Randomised Comparison,” Lancet, Vol. 369, pp. 465-473 (2007)
`Angiolillo, D., et al., “Impact of Concomitant Low-Dose Aspirin on
`the Safety and Tolerability of Naproxen and Esomeprazole
`Magnesium Delayed-Release Tablets in Patients Requiring Chronic
`Nonsteroidal Anti-Inflammatory Drug Therapy: an Analysis from 5
`Phase III Studies,” J Thromb Thrombolysis, Vol. 38, pp. 11-23
`(2014; first published 12/25/2013) doi: 10.1007/s11239-013-1035-4
`Declaration of Lee S. Simon, MD, FACP, FACR, submitted May
`22, 2015 from File History of U.S. Patent Application No.
`14/593,212
`Goldstein, J.L., et al., “PN400 Significantly Reduces the Incidence
`of Gastric Ulcers Compared With Enteric-Coated Naproxen in
`Patients Requiring Chronic NSAID Therapy Regardless of Low-
`Dose Aspirin Use: Results from Two Prospective, Randomized
`Controlled Trials,” Arthritis Rheum, 60 Suppl. 10:842 (2009)
`Gabriel, S.E., et al., “Risk for Serious Gastrointestinal
`Complications Related to Use of Nonsteroidal Anti-inflammatory
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
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`IPR2015-01718
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`Page 1
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`

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`2009
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`2010
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`2011
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`2012
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`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`Drugs,” Annals of Internal Medicine, Vol. 115, No. 10, pp. 787-796
`(1991)
`Cryer, B. and Feldman, M., “Effects of Nonsteroidal Anti-
`inflammatory Drugs on Endogenous Gastrointestinal
`Prostaglandins and Therapeutic Strategies for Prevention and
`Treatment of Nonsteroidal Anti-inflammatory Drug-Induced
`Damage,” Archives of Internal Medicine, Vol. 152, No. 6, pp.
`1145-1155 (1992)
`Fries, J.F., et al., “Nonsteroidal Anti-inflammatory Drug-
`Associated Gastropathy: Incidence and Risk Factor Models,” The
`American Journal of Medicine, Vol. 91, pp. 213-222 (1991)
`Sørensen, H.T., et al., “Risk of Upper Gastrointestinal Bleeding
`Associated With Use of Low-Dose Aspirin,” The American Journal
`of Gastroenterology, Vol. 95, No. 9, pp. 2218-2224 (2000)
`Tamura, A., et al., “Prevalence and independent factors for
`gastroduodenal ulcers/erosions in asymptomatic patients taking
`low-dose aspirin and gastroprotective agents: the OITA-GF study,”
`The Quarterly Journal of Medicine, Vol. 104, pp. 133-139 (2010)
`Derry, S. and Loke, Y.K., “Risk of gastrointestinal haemorrhage
`with long term use of aspirin: meta-analysis,” British Medical
`Journal, Vol. 321, pp. 1183-1187 (2000)
`Rodriguez, L.A.G., et al., “Association between aspirin and upper
`gastrointestinal complications: Systematic review of epidemiologic
`studies,” British Journal of Clinical Pharmacology, Vol. 52, pp.
`563-571 (2001)
`Bellary, S.V., et al., “Upper Gastrointestinal Lesions in Elderly
`Patients Presenting for Endoscopy: Relevance of NSAID Usage,”
`The American Journal of Gastroenterology, Vol. 86, No. 8, pp.
`961-964 (1991)
`Weil, J., et al., “Prophylactic aspirin and risk of peptic ulcer
`bleeding,” British Medical Journal, Vol. 310, pp. 827-830 (1995)
`Goldstein, J.L., et al., “Effects of Concomitant Aspirin (81 mg qd)
`On Incidence of Gastric and/Or Duodenal Ulcers in Healthy
`Subjects Taking Celecoxib Or Naproxen: A Randomized, Placebo-
`Controlled Trial,” Gastroenterology, Vol. 130 (suppl. 2), pp. A-81-
`A-82 (2006)
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`2018
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`2019
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`2020
`2021
`2022
`2023
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`2024
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`2025
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`2026
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`2027
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`2028
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`2029
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`Rahme, E., et al., “Gastrointestinal Effects of Rofecoxib and
`Celecoxib Versus NSAIDs Among Patients on Low Dose Aspirin,”
`Gastroenterology, 126 (suppl. 2), pp. A-1-A-2 (2004)
`Silverstein, F.E., et al., “Gastrointestinal Toxicity With Celecoxib
`vs Nonsteroidal Anti-inflammatory Drugs for Osteoarthritis and
`Rheumatoid Arthritis,” The Journal of the American Medical
`Association, Vol. 284, No. 10, pp. 1247-1255 (2000)
`Deposition Transcript of Leon Shargel
`Declaration of Robert W. Makuch, Ph.D.
`Declaration of David A. Johnson, M.D.
`Lee M., et al, “Dose effects of aspirin on gastric prostaglandins and
`stomach mucosal injury,” Ann Intern Med, Vol. 120, No. 3, pp.
`184-189 (1994)
`Serrano P., et al., “Risk of upper gastrointestinal bleeding in
`patients taking low-dose aspirin for the prevention of
`cardiovascular diseases,” Aliment Pharmacol Ther, Vol. 16, pp.
`1945-1953 (2002) doi:10.1046/j.0269-2813.2002.01355.x
`Chan, F.K., “Anti-platelet therapy and managing ulcer risk,” J
`Gastroenterol Hepatol, Vol. 27, pp. 195-199 (2012)
`Goldstein, J.L., et al, “The impact of low-dose aspirin on
`endoscopic gastric and duodenal ulcer rates in users of a non-
`selective non-steroidal anti-inflammatory drug or a cyclo-
`oxygenase-2-selective inhibitor,” Aliment Pharmacol Ther, Vol. 23,
`pp. 1489-1498 (2006) doi:10.1111/j.1365-2036.2006.02912.x
`Goldstein, J.L., et al, “Clinical trial incidence of NSAID-associated
`endoscopic gastric ulcers in patients treated with PN 400 (naproxen
`plus esomeprazole magnesium) vs. enteric-coated naproxen alone,”
`Aliment Pharmacol Ther, Vol. 32, pp. 401-413(2010)
`doi:10.1111/j.1365-2036.2010.04378.x
`Sostres C. and Gargallo C.J., “Gastrointestinal lesions and
`complications of low-dose aspirin in the gastrointestinal tract,” Best
`Pract Res Clin Gastroenterol., Vol. 26, pp. 141-151 (2012) doi:
`10.1016/j.bpg.2012.01.016
`Wolfe, M., et al, “Gastrointenstinal Toxicity of Nonsteroidal
`Antiinflammatory Drugs,” The New England Journal of Medicine,
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`2030
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`2031
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`2032
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`2033
`
`Vol. 340, No. 24, pp. 1888-1899 (1999)
`Flower, R., “The Development of COX2 Inhibitors,” Nature
`Reviews Drug Discovery, Vol. 2, pp. 179-191 (2003)
`Public Health Advisory - FDA Announces Important Changes and
`Additional Warnings for COX-2 Selective and Non-Selective Non-
`Steroidal Anti-Inflammatory Drugs (NSAIDs) (April 7, 2005),
`downloaded from
`http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInfor
`mationforPatientsandProviders/ucm150314.htm on March 23, 2015
`Whitlock , C., et al, “Bleeding Risks With Aspirin Use for Primary
`Prevention in Adults: A Systematic Review for the U.S. Preventive
`Services Task Force,” Annals of Internal Medicine, Vol. 164, No.
`12, pp. 826-837 (2016)
`Bombardier, E., et al, “Comparison of Upper Gastrointestinal
`Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid
`Arthritis,” The New England Journal of Medicine, Vol. 343, No.
`21, pp. 1520-1528 (2000)
`
`
`
`
`
`
`By: /s/ Ricardo Rodriguez
`Ricardo Rodriguez
`Reg. No. 40,789
`Counsel for Patent Owner
`
`
`
`
`
`Dated: June 23, 2016
`
`  
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`IPR2015-01718
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`Page 4
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`
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`CERTIFICATION OF SERVICE UNDER 37 C.F.R. § 42.6(e)
`I hereby certify that on the date indicated below, the foregoing Patent
`
`Owner’s Response, including all exhibits and all other papers filed with it, was
`
`served electronically via email on the following counsel for the Petitioner, as
`
`consented to by said counsel:
`
`
`
`Jerry C. Harris, Jr. (Reg. No. 66,822)
`
`Amy E. LaValle (Reg. No. 51,092)
`
`Wick Phillips Gould & Martin, LLP
`
`3131 McKinney Avenue, Suite 100
`
`Dallas, TX 75204
`
`(214) 692-6200 (phone)
`
`(214) 692-6255 (fax)
`
`jerry.harris@wickphillips.com
`
`amy.lavalle@wickphillips.com
`
`
`
`Dated: June 23, 2016
`
`
`
`
`
`
`
`
`
`By: /s/ Ricardo Rodriguez
`Ricardo Rodriguez
`Reg. No. 40,789
`Counsel for Patent Owner
`
`IPR2015-01718
`
`
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`Page 5