Paper 3
`Date: August 12, 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,
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`v.
`
`HORIZON PHARMA USA, INC.,
`Patent Owner.
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`IPR2015-01718
`Patent 8,945,621
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`PETITIONER’S EXHIBIT LIST
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`Date: August 12, 2015
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`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`COALITION FOR AFFORDABLE DRUGS VII LLC,
`Petitioner,
`
`v.
`
`HORIZON PHARMA USA, INC.,
`Patent Owner.
`
`
`
`
`
`
`
`
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`
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`
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`
`IPR2015-01718
`Patent 8,945,621
`
`
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`PETITIONER’S EXHIBIT LIST
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`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits this current list of
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`IPR2015-01718
`Patent 8,945,621
`
`
`
`exhibits.
`
`Exhibit No. Description
`
`1001
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`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
`
`U.S. Patent No. 8,945,621 (“the ’621 Patent”)
`
`File History of the ’621 Patent, U.S. Patent App. No. 12/822,612
`(“the ’612 Application”)
`
`Declaration of Leon Shargel, Ph.D., R.Ph.
`
`U.S. Patent No. 6,926,907 (“Plachetka”)
`
`“Ulcer Prevention in Long-term Users of Nonsteroidal Anti-
`inflammatory Drugs,” David Y. Graham, et al., Archives of Internal
`Medicine, Vol. 162, January 28, 2002
`
`“Ulcer Recurrence in High-Risk Patients Receiving Nonsteroidal
`Anti-Inflammatory Drugs Plus Low-Dose Aspirin: Results of a Post
`Hoc Subanalysis,” Jay L. Goldstein, et al., Clinical Therapeutics,
`Vol. 26, No. 10, October 2004
`
`“Horizon Pharma Announces Agreement to Acquire U.S. Rights to
`VIMOVO(R) and Provides 2014 Guidance,” Horizon Pharma
`(Nov. 19, 2013)
`
`Horizon Pharma plc 2014 Irish Statutory Accounts, Horizon
`Pharma Public Limited Company (Apr. 9, 2015)
`
`“Pharmaceutical Companies Buy Rivals’ Drugs, Then Jack Up the
`Prices,” The Wall Street Journal (Apr. 26, 2015)
`
`U.S. Patent No. 4,757,060
`
`“The Mechanism of Action of Aspirin,” J.R. Vane, et al., Pergamon
`(June 15, 2003)
`
`1012
`
`G.B. Patent No. 1211134
`
`1
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`
`
`Exhibit No. Description
`
`IPR2015-01718
`Patent 8,945,621
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`“Drug-Induced Peptic Ulcer Disease,” Valerie Vella, Journal of the
`Malta College of Pharmacy Practice, Issue 10 (2005)
`
`“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
`
`“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. 2002/0045184 (“Chen”)
`
`U.S. Patent No. 5,698,225
`
`2
`
`
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`IPR2015-01718
`Patent 8,945,621
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`Exhibit No. Description
`
`1025
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`1026
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`1027
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`1028
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`1029
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`1030
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`1031
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`1032
`
`1033
`
`1034
`
`1035
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`“Management of NSAID-Related Gastrointestinal Mucosal Injury,”
`Adam F. Barrison, et al., Inflammopharmacology, Vol. 7, No. 3
`(Sept. 1999)
`
`“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. Pat. No. 6,319,519
`
`“Remington’s Pharmaceutical Sciences,” Alfonso R. Gennaro, et
`al., Mack Publ’g Co., Seventeenth Edition, (1985) (“Remington”)
`
`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)
`
`Shargel Walmart Receipts
`
`U.S. Patent No. 6,224,911
`
`Int’l Patent Pub. No. WO 01/19346
`
`“Pharmacology of Proton Pump Inhibitors,” Jai Moo Shin, et al.,
`Current Gastroenterology Reports, Vol. 10, Issue 6 (Dec. 2008)
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`3
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`IPR2015-01718
`Patent 8,945,621
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`Respectfully submitted,
`
`
`
`
`
`
`
`/Jerry C. Harris, Jr./
`Jerry C. Harris, Jr. (Reg. No. 66,822)
`Amy E. LaValle (Reg. No. 51,092)
`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)
`jcharris@conleyrose.com
`alavalle@conleyrose.com
`rcarroll@conleyrose.com
`
`Counsel for Petitioner
`Coalition for Affordable Drugs VII LLC
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`4
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`Date: August 12, 2015
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`CERTIFICATE OF SERVICE
`
`IPR2015-01718
`Patent 8,945,621
`
`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on August 12, 2015 a
`
`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
`
`serving the correspondence address of record for the ’621 Patent:
`
`
`
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`
`
`/Jerry C. Harris, Jr./
`Lead Counsel for Petitioner
`Coalition for Affordable Drugs VII LLC
`
`
`
`
`
`Steven L. Highlander
`Parker Highlander PLLC
`1120 South Capital of Texas Highway
`Bldg. 1, Suite 200
`Austin, Texas 78746
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`
`
`Date: August 12, 2015
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`
`
`5
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