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.
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`POZEN INC.,
`Patent Owner.
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`IPR2015-01718
`Patent 8,945,621
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`PETITIONER’S UPDATED EXHIBIT LIST
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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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`IPR2015-01718
`Patent 8,945,621
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`PETITIONER’S UPDATED EXHIBIT LIST
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`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits the following current
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`IPR2015-01718
`Patent 8,945,621
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`
`
`Exhibit List:
`
`Exhibit No. Description
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`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
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`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
`
`
`
`
`
`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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`
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`Exhibit No. Description
`
`IPR2015-01718
`Patent 8,945,621
`
`
`1025
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`1026
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`1027
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`1028
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`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`“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)
`
`Orange Book Patent Data for: N022511, Product 001,
`ESOMEPRAZOLE MAGNESUM; NAPROXEN (VIMOVO)
`TABLET, DELAYED RELEASE EQ 20MG BASE; 500MG
`
`1037
`
`Deposition Transcript of David A. Johnson, M.D. (Aug. 27, 2016)
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`3
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`
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`IPR2015-01718
`Patent 8,945,621
`
`
`Exhibit No. Description
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`1038
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`Deposition Transcript of Robert W. Makuch, Ph.D. (Sept. 19,
`2016)
`
`Respectfully submitted,
`
`
`
`
`
`/Amy E. LaValle/
`Amy E. LaValle (Reg. No. 51,092)
`Jerry C. Harris, Jr. (Reg. No. 66,822)
`WICK PHILLIPS GOULD & MARTIN, LLP
`3131 McKinney Avenue, Suite 100
`Dallas, TX 75204
`(214) 692-6200 (phone)
`(214) 692-6255 (fax)
`amy.lavalle@wickphillips.com
`jerry.harris@wickphillips.com
`
`Counsel for Petitioner
`Coalition for Affordable Drugs VII LLC
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`Date: September 29, 2016
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`4
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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 September 29, 2016
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`a copy of the foregoing PETITIONER’S UPDATED EXHIBIT LIST was provided
`
`via email to the following counsel of record for Patent Owner:
`
`Lead Counsel
`Ricardo Rodriguez
`COOLEY LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`Tel: (650) 843-5046
`Fax: (650) 843-7400
`rr@cooley.com
`zIPR2015-01718@cooley.com
`
`Back-Up Counsel
`Lauren L. Stevens, Ph.D.
`HORIZON PHARMA USA, INC.
`150 S. Saunders Road
`Lake Forest, Illinois 60045
`Tel: (224) 383-3265
`Fax: (224) 383-3001
`lstevens@horizonpharma.com
`
`Back-Up Counsel
`Stephen M. Hash, Ph.D.
`BAKER BOTTS LLP
`98 San Jacinto Blvd., Suite 1500
`Austin, TX 78701-4078
`Tel: (512) 322-2587
`Fax: (512) 322-3687
`stephen.hash@bakerbotts.com
`PozenVimovoBB@bakerbotts.com
`
`Back-Up Counsel
`Thomas A. Blinka, Ph.D.
`COOLEY LLP
`1299 Pennsylvania Avenue, NW
`Suite 700
`Washington, DC 20004-2400
`Tel: (202) 842-7800
`Fax: (202) 842-7899
`tblinka@cooley.com
`
`Back-Up Counsel
`Dennis Bennett
`GLOBAL PATENT GROUP, LLC
`1005 N. Warson Road, Suite 404
`St. Louis, MO 63132
`Tel: (314) 812-8018
`Fax: (314) 685-2300
`dennisbennett@globalpatentgroup.com
`
`Back-Up Counsel
`Margaret J. Sampson, Ph.D.
`BAKER BOTTS LLP
`98 San Jacinto Blvd., Suite 1500
`Austin, TX 78701-4078
`Tel: (512) 322-2552
`Fax: (512) 322-3652
`margaret.sampson@bakerbotts.com
`
`5
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`
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`IPR2015-01718
`Patent 8,945,621
`
`
`Back-Up Counsel
`Kevin Laurence
`RENAISSANCE IP LAW GROUP LLP
`1940 Duke Street, Second Floor
`Alexandria, VA 22314
`Tel: (703) 463-0640
`Fax: (503) 517-9919
`kevin.laurence@renaissanceiplaw.com
`
`
`
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`
`
`/Amy E. LaValle/
`Lead Counsel for Petitioner
`Coalition for Affordable Drugs VII LLC
`
`
`
`
`Back-Up Counsel
`Jeffrey S. Gritton
`BAKER BOTTS LLP
`98 San Jacinto Blvd., Suite 1500
`Austin, TX 78701-4078
`Tel: (512) 322-2624
`Fax: (512) 322-3652
`Jeff.Gritton@bakerbotts.com
`
`Back-Up Counsel
`Matthew Phillips
`RENAISSANCE IP LAW GROUP LLP
`7327 SW Barnes Road #521
`Portland, OR 97225
`Tel: (503) 964-1129
`Fax: (503) 517-9919
`matthew.phillips@renaissanceiplaw.com
`
`
`
`Date: September 29, 2016
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`
`
`6
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